Forest Lab. Inc. - wächst seit 10 Jahren - 500 Beiträge pro Seite
eröffnet am 16.01.05 16:20:32 von
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Beiträge: 87
ID: 944.090
ID: 944.090
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ISIN: US3458381064 · WKN: 856886
Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 6,0000 | +25,00 | |
| 0,6674 | +21,35 | |
| 0,7050 | +20,82 | |
| 9,5000 | +18,75 | |
| 0,6400 | +18,52 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 9,7200 | -19,60 | |
| 0,9250 | -23,55 | |
| 4,0000 | -27,27 | |
| 2,7280 | -29,14 | |
| 14,510 | -32,32 |
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@ alle
nachdem ich nun schon fast 5 Jahre bei WO registriert bin, wird es doch mal Zeit für meinen ersten Thread.
Ich möchte ein Pharma Unternehmen vorstellen, das aus meiner Sicht letztes Jahr zu unrecht ziemlich heftig unter die Räder gekommen ist. Vermutlich im Sog der Ereignisse um Pfizer und Merck (Vioxx) sowie das Auslaufen des Patentes für Celexa, ging der Kurs um fast 50% in den Keller, wodurch man jetzt aber Anteile eines hervorragenden Unternehmens so günstig erwerben kann wie seit 10 Jahren nicht mehr.
Hier ein Auszug von der Homepage :
------
Forest identifies, develops and delivers pharmaceutical products that make a difference in people`s lives. Lexapro is the fastest growing SSRI antidepressant in the United States. Benicar has become an important treatment option for hypertension. Namenda, our latest product, is the first approved therapy in the United States for those with moderate to severe Alzheimer`s disease.
"We have been extremely successful in meeting our business objectives and expanding our franchises," says Howard Solomon, Forest`s chairman and chief executive officer. "But there is a satisfaction beyond profits in helping to bring relief to people who are suffering."
Based in New York, Forest has operations on Long Island, in New Jersey, Missouri, Ohio, Ireland and the United Kingd
-----
Dem interessierten Anleger empfehle ich auch einen Blick in die Geschäftesberichte zu werfen und da insbesondere den Brief an die Aktionäre. FRX ist in den vergangenen 10 Jahren kontinuierlich gewachsen und zwar aus eigener Kraft organisch, nicht durch Zukäufe wie viele andere. Dabei konnte der Umsatz von 350 Mio. auf über 3 Mrd. US$, die für 2005 erwartet werden, gesteigert werden und das bei einer Eigenkapitalquote von ca. 90%.
Um beurteilen zu können, ob das Unternehmen ein Value Investment sein könnte, stelle ich nach wie vor die folgenden 7 Value Fragen (siehe auch : V. Gelfarth / M. Otte; Investieren statt spekulieren)
1) Ist das Unternehmen einfach zu verstehen, hat es eine beständige Firmengeschichte ?
Wenn man mal davon absieht, dass ich kein Mediziner bin, so hat es aus meiner Sichtweise definitiv eine beständige Firmengeschichte und ist auch einfach zu verstehen.
Antwort auf die Value-Frage : Kriterium klar erfüllt
2) Werden die Produkte dringend benötigt, gibt es keinen direkten Ersatz ?
Forest Lab. hat eine ganze Reihe von Produkten auf dem Markt. Die Produkte werden zwar dringend benötigt, aber es gibt ebenso auch direkten Ersatz, nämlich von den Mitbewerbern.
Allerdings verspricht sich FRX eine Menge von dem 2004 auf den Markt gekommenen Präparat „Namenda“
Hier ein Auszug von der FRX Homepage :
NAMENDA is the first and only medication approved to treat moderate to severe Alzheimer`s disease. Of the 4.5 million people that have Alzheimer`s disease, the majority are in the moderate to severe stages. NAMENDA works in an entirely different way than currently available medications, and provides benefits when used alone, or in combination with an acetylcholinesterase inhibitor (AChEI).
Anfang 2005 wurde mit Camparel erstmals seit 10 Jahren wieder ein neues Medikament gegen Alkoholabhängigkeit auf den Markt gebracht.
Um eine fundierte Antwort auf die Frage 2) geben zu können, müsste man wohl eher einen Mediziner zu rate ziehen. Daher lasse ich das hier mal offen.
3) Gibt es wenig Restriktionen, ist die Produktion einfach auszudehnen ?
Auf keinen Fall. In wohl kaum einem Bereich gibt es derart viele Restriktionen wie im Pharmabereich.
4) Sind die Produkte eindeutig von Konkurrenzprodukten zu unterscheiden ?
Da FRX bislang nur in den USA, England und Irland vertreten ist, vermag ich auch das nicht zu beurteilen. Ich halte das aber auch nicht für so entscheidend, da der Endverbraucher mit z.B. Alzheimer, Erkrankungen des Nervensystems oder Bluthochdruck wohl eher nicht in die Apotheke geht, um sich was dagegen zu kaufen. Daher dürfte mehr von Bedeutung sein, welche Reputation die Produkte bei den Medizinern haben.
5) Hat das Unternehmen eine monopolartige Stellung ?
Nein, sicher nicht.
6) Hat das Unternehmen noch Wachstumspotential ? Wird die Nachfrage noch wachsen ?
Mit großer Wahrscheinlichkeit ja. Das Unternehmen ist frei von Bankschulden, macht seit Jahren gute Gewinne und hat daher beste Vorraussetzungen, die Entwicklung neuer Produkte vorantreiben zu können. Diverse neue Produkte sind gerade am Markt eingeführt oder deren Einführung steht in 2005 an.
Allerdings gibt es auch Risiken. Die Phase III Ergebnisse von Neramexane (ebenfalls einem Alzheimer Medikament) waren enttäuschend und 2005 läuft der Patentschutz für das umsatzstärkste Produkt Celexa aus. Allerdings verschieben sich die Umsätze (immerhin knapp 1,1 Mrd.) ohnehin geplant von Celexa zum „Nachfolger“ Lexapro, der kontinuierlich hinzugewinnt und 2 Jahre nach Markteinführung schon auf einen Marktanteil von ca. 15% kommt.
Ich würde die Frage daher mit ja beantworten.
7) Hat das Unternehmen eine weitgehende Gestaltungsfreiheit der Preise ?
Es hängt viel davon ab, ob die Medikamente einen echten Vorteil gegenüber den Produkten der Wettbewerber haben. In der Vergangenheit scheint es so gewesen zu sein, zumindest hat FRX seit vielen Jahren beeindruckende Wachstumsraten erzielen können.
Daher scheint mir dieses Kriterium momentan erfüllt.
Die messbaren Qualitätskriterien :
1) Eigenkapitalquote (soll > 30%)
Die Eigenkapitalquote liegt bei aktuell ca. 85% und hat auch schon immer in der Größenordnung gelegen. Es gibt keine langfristigen Schulden.
Das Kriterium ist klar erfüllt.
2) Eigenkapitalrendite (soll > 25%)
Die Eigenkapitalrendite schwankte in den vergangenen 10 Jahren zwischen ca. 10% und 25% und war 1997 sogar einmal negativ. Dennoch reicht mir, in Anbetracht der hohen Eigenkapitalquote, die Rendite von zuletzt zwischen 20% und 26% (2002 – 2005e) allemal aus.
3) Gewinnwachstum (soll >10%)
Egal, ob man einen 10, 5 oder 3 Jahresdurchschnitt betrachtet, 10% Wachstum wurden immer erreicht.
Auch dieses Kriterium ist erfüllt.
4) Verzinsung der einbehaltenen Gewinne (soll > 15%)
Eine Dividende wird nicht gezahlt und wurde auch noch nie gezahlt. Das Unternehmen kauft derzeit eigene Aktien zurück.
5) Umsatzrendite (soll > 10%)
Hier gilt, was auch schon zur Eigenkapitalrendite zu sagen war. In den letzten Jahren beständig über 20%.
Kriterium erfüllt
6) Cash-Flow-Marge (soll > 15%)
Hier sieht es ebenfalls ähnlich aus wie bei der Umsatz- und Eigenkapitalrendite. Zuletzt Werte von über 20% vereinzelt sogar über 30%. Selbst im 10-Jahresdurschnitt sind es 20%.
Kriterium daher erfüllt.
7) Sachinvestitionen (soll <40% des Cash Flows)
Die Sachinvestitionen machten in den letzten Jahren etwa 10% - 20% des Cash Flows aus.
Kriterium erfüllt.
Fazit : Nach meinem Verständnis sind alle 7 Kriterien erfüllt und das hatte ich lange nicht mehr.
Die Signale, oder der Versuch den Wert eines Unternehmens zu berechnen :
Signal 1 (DNCF)
Ich habe mal ein NCF-Wachstum von 12% für die nächsten 10 Jahre angesetzt, was signifikant unter allen Durchschnittswerten der Vergangenheit liegt. Damit komme ich bei einer Diskontierungsrate von 6% noch auf eine Sicherheitsmarge von ca. 27%. Oder anders ausgedrückt : nach dieser Berechnung wäre FRX, wenn sie denn den NCF die nächsten 10 Jahre um durchschnittlich 12% steigern könnten, zur Zeit etwa 54 US$ wert.
Signal 2 (Gewinne / KGV)
Bei dieser Berechnung ergibt sich auf 5-Jahressicht eine zu erwartende Wertsteigerung von durchschnittlich 81% und auf 10-Jahressicht von 34%. Das ist aber reine Mathematik, es wird einfach das Wachstum der Vergangenheit in Zukunft extrapoliert.
Signal 3 (Eigenkapitalrendite und KGV)
Dieses Verfahren errechnet mir einen Wert von 271 U$ in 10 Jahren, was einer durchschnittlichen Steigerung von 20% pro Jahr entspricht.
Signal 4 (Berechnung des Downside Target)
Ich verwende seit einiger Zeit Daten des Benchmarkinvesting zum „screenen“. Demnach notiert FRX sowohl auf 5- wie auch aus 10-Jahressicht ca. 40% unter seinem Downside Target.
Wer sich dafür interessiert kann unter http://www.benchmarkinvesting.com nachsehen, worum es sich dabei handelt.
Gruß
Balou
nachdem ich nun schon fast 5 Jahre bei WO registriert bin, wird es doch mal Zeit für meinen ersten Thread.
Ich möchte ein Pharma Unternehmen vorstellen, das aus meiner Sicht letztes Jahr zu unrecht ziemlich heftig unter die Räder gekommen ist. Vermutlich im Sog der Ereignisse um Pfizer und Merck (Vioxx) sowie das Auslaufen des Patentes für Celexa, ging der Kurs um fast 50% in den Keller, wodurch man jetzt aber Anteile eines hervorragenden Unternehmens so günstig erwerben kann wie seit 10 Jahren nicht mehr.
Hier ein Auszug von der Homepage :
------
Forest identifies, develops and delivers pharmaceutical products that make a difference in people`s lives. Lexapro is the fastest growing SSRI antidepressant in the United States. Benicar has become an important treatment option for hypertension. Namenda, our latest product, is the first approved therapy in the United States for those with moderate to severe Alzheimer`s disease.
"We have been extremely successful in meeting our business objectives and expanding our franchises," says Howard Solomon, Forest`s chairman and chief executive officer. "But there is a satisfaction beyond profits in helping to bring relief to people who are suffering."
Based in New York, Forest has operations on Long Island, in New Jersey, Missouri, Ohio, Ireland and the United Kingd
-----
Dem interessierten Anleger empfehle ich auch einen Blick in die Geschäftesberichte zu werfen und da insbesondere den Brief an die Aktionäre. FRX ist in den vergangenen 10 Jahren kontinuierlich gewachsen und zwar aus eigener Kraft organisch, nicht durch Zukäufe wie viele andere. Dabei konnte der Umsatz von 350 Mio. auf über 3 Mrd. US$, die für 2005 erwartet werden, gesteigert werden und das bei einer Eigenkapitalquote von ca. 90%.
Um beurteilen zu können, ob das Unternehmen ein Value Investment sein könnte, stelle ich nach wie vor die folgenden 7 Value Fragen (siehe auch : V. Gelfarth / M. Otte; Investieren statt spekulieren)
1) Ist das Unternehmen einfach zu verstehen, hat es eine beständige Firmengeschichte ?
Wenn man mal davon absieht, dass ich kein Mediziner bin, so hat es aus meiner Sichtweise definitiv eine beständige Firmengeschichte und ist auch einfach zu verstehen.
Antwort auf die Value-Frage : Kriterium klar erfüllt
2) Werden die Produkte dringend benötigt, gibt es keinen direkten Ersatz ?
Forest Lab. hat eine ganze Reihe von Produkten auf dem Markt. Die Produkte werden zwar dringend benötigt, aber es gibt ebenso auch direkten Ersatz, nämlich von den Mitbewerbern.
Allerdings verspricht sich FRX eine Menge von dem 2004 auf den Markt gekommenen Präparat „Namenda“
Hier ein Auszug von der FRX Homepage :
NAMENDA is the first and only medication approved to treat moderate to severe Alzheimer`s disease. Of the 4.5 million people that have Alzheimer`s disease, the majority are in the moderate to severe stages. NAMENDA works in an entirely different way than currently available medications, and provides benefits when used alone, or in combination with an acetylcholinesterase inhibitor (AChEI).
Anfang 2005 wurde mit Camparel erstmals seit 10 Jahren wieder ein neues Medikament gegen Alkoholabhängigkeit auf den Markt gebracht.
Um eine fundierte Antwort auf die Frage 2) geben zu können, müsste man wohl eher einen Mediziner zu rate ziehen. Daher lasse ich das hier mal offen.
3) Gibt es wenig Restriktionen, ist die Produktion einfach auszudehnen ?
Auf keinen Fall. In wohl kaum einem Bereich gibt es derart viele Restriktionen wie im Pharmabereich.
4) Sind die Produkte eindeutig von Konkurrenzprodukten zu unterscheiden ?
Da FRX bislang nur in den USA, England und Irland vertreten ist, vermag ich auch das nicht zu beurteilen. Ich halte das aber auch nicht für so entscheidend, da der Endverbraucher mit z.B. Alzheimer, Erkrankungen des Nervensystems oder Bluthochdruck wohl eher nicht in die Apotheke geht, um sich was dagegen zu kaufen. Daher dürfte mehr von Bedeutung sein, welche Reputation die Produkte bei den Medizinern haben.
5) Hat das Unternehmen eine monopolartige Stellung ?
Nein, sicher nicht.
6) Hat das Unternehmen noch Wachstumspotential ? Wird die Nachfrage noch wachsen ?
Mit großer Wahrscheinlichkeit ja. Das Unternehmen ist frei von Bankschulden, macht seit Jahren gute Gewinne und hat daher beste Vorraussetzungen, die Entwicklung neuer Produkte vorantreiben zu können. Diverse neue Produkte sind gerade am Markt eingeführt oder deren Einführung steht in 2005 an.
Allerdings gibt es auch Risiken. Die Phase III Ergebnisse von Neramexane (ebenfalls einem Alzheimer Medikament) waren enttäuschend und 2005 läuft der Patentschutz für das umsatzstärkste Produkt Celexa aus. Allerdings verschieben sich die Umsätze (immerhin knapp 1,1 Mrd.) ohnehin geplant von Celexa zum „Nachfolger“ Lexapro, der kontinuierlich hinzugewinnt und 2 Jahre nach Markteinführung schon auf einen Marktanteil von ca. 15% kommt.
Ich würde die Frage daher mit ja beantworten.
7) Hat das Unternehmen eine weitgehende Gestaltungsfreiheit der Preise ?
Es hängt viel davon ab, ob die Medikamente einen echten Vorteil gegenüber den Produkten der Wettbewerber haben. In der Vergangenheit scheint es so gewesen zu sein, zumindest hat FRX seit vielen Jahren beeindruckende Wachstumsraten erzielen können.
Daher scheint mir dieses Kriterium momentan erfüllt.
Die messbaren Qualitätskriterien :
1) Eigenkapitalquote (soll > 30%)
Die Eigenkapitalquote liegt bei aktuell ca. 85% und hat auch schon immer in der Größenordnung gelegen. Es gibt keine langfristigen Schulden.
Das Kriterium ist klar erfüllt.
2) Eigenkapitalrendite (soll > 25%)
Die Eigenkapitalrendite schwankte in den vergangenen 10 Jahren zwischen ca. 10% und 25% und war 1997 sogar einmal negativ. Dennoch reicht mir, in Anbetracht der hohen Eigenkapitalquote, die Rendite von zuletzt zwischen 20% und 26% (2002 – 2005e) allemal aus.
3) Gewinnwachstum (soll >10%)
Egal, ob man einen 10, 5 oder 3 Jahresdurchschnitt betrachtet, 10% Wachstum wurden immer erreicht.
Auch dieses Kriterium ist erfüllt.
4) Verzinsung der einbehaltenen Gewinne (soll > 15%)
Eine Dividende wird nicht gezahlt und wurde auch noch nie gezahlt. Das Unternehmen kauft derzeit eigene Aktien zurück.
5) Umsatzrendite (soll > 10%)
Hier gilt, was auch schon zur Eigenkapitalrendite zu sagen war. In den letzten Jahren beständig über 20%.
Kriterium erfüllt
6) Cash-Flow-Marge (soll > 15%)
Hier sieht es ebenfalls ähnlich aus wie bei der Umsatz- und Eigenkapitalrendite. Zuletzt Werte von über 20% vereinzelt sogar über 30%. Selbst im 10-Jahresdurschnitt sind es 20%.
Kriterium daher erfüllt.
7) Sachinvestitionen (soll <40% des Cash Flows)
Die Sachinvestitionen machten in den letzten Jahren etwa 10% - 20% des Cash Flows aus.
Kriterium erfüllt.
Fazit : Nach meinem Verständnis sind alle 7 Kriterien erfüllt und das hatte ich lange nicht mehr.
Die Signale, oder der Versuch den Wert eines Unternehmens zu berechnen :
Signal 1 (DNCF)
Ich habe mal ein NCF-Wachstum von 12% für die nächsten 10 Jahre angesetzt, was signifikant unter allen Durchschnittswerten der Vergangenheit liegt. Damit komme ich bei einer Diskontierungsrate von 6% noch auf eine Sicherheitsmarge von ca. 27%. Oder anders ausgedrückt : nach dieser Berechnung wäre FRX, wenn sie denn den NCF die nächsten 10 Jahre um durchschnittlich 12% steigern könnten, zur Zeit etwa 54 US$ wert.
Signal 2 (Gewinne / KGV)
Bei dieser Berechnung ergibt sich auf 5-Jahressicht eine zu erwartende Wertsteigerung von durchschnittlich 81% und auf 10-Jahressicht von 34%. Das ist aber reine Mathematik, es wird einfach das Wachstum der Vergangenheit in Zukunft extrapoliert.
Signal 3 (Eigenkapitalrendite und KGV)
Dieses Verfahren errechnet mir einen Wert von 271 U$ in 10 Jahren, was einer durchschnittlichen Steigerung von 20% pro Jahr entspricht.
Signal 4 (Berechnung des Downside Target)
Ich verwende seit einiger Zeit Daten des Benchmarkinvesting zum „screenen“. Demnach notiert FRX sowohl auf 5- wie auch aus 10-Jahressicht ca. 40% unter seinem Downside Target.
Wer sich dafür interessiert kann unter http://www.benchmarkinvesting.com nachsehen, worum es sich dabei handelt.
Gruß
Balou
hört sich alles nicht schlecht an.
Mich stören momentan noch(Daten aus 2002!)
-Mktkap. von über 10Mrd USD
-steigende Aktienzahl (bis 2002!)
-keine Monopolartige Stellung - Produkt kann ausgetauscht werden!
Ansonsten sieht es sehr gut aus
R.R.
Mich stören momentan noch(Daten aus 2002!)
-Mktkap. von über 10Mrd USD
-steigende Aktienzahl (bis 2002!)
-keine Monopolartige Stellung - Produkt kann ausgetauscht werden!
Ansonsten sieht es sehr gut aus
R.R.
Ich nutze als Datenquelle entweder Valueline.com oder http://quicktake.morningstar.com/Stock/Income10.asp?Country=…
Im letzten Quartal wurden lt. Quartalsbericht ca. 2,3 Mio Aktien zurückgekauft.
Die MK liegt derzeit bei ca. 15 Mrd. US$, lag aber nach meinen Daten 2002 auch schon so hoch, allerdings bei nur etwas über 60% des heutigen Umsatzes und weniger als 50% des 2004er Gewinns.
Gruß
Balou
Im letzten Quartal wurden lt. Quartalsbericht ca. 2,3 Mio Aktien zurückgekauft.
Die MK liegt derzeit bei ca. 15 Mrd. US$, lag aber nach meinen Daten 2002 auch schon so hoch, allerdings bei nur etwas über 60% des heutigen Umsatzes und weniger als 50% des 2004er Gewinns.
Gruß
Balou
@Balue2
Kompliment für deine sehr gute Analyse! Das ist mit Abstand die beste Analyse, die ich seit langer Zeit gelesen habe (viele Analysten machen sich weniger Gedanken).
Wo ist die Quelle deiner Signalberechnung zu finden?
Unterschiedliche Ergebnisse - wie gewichtest du sie?
Ein Patentablauf (Nachfolger zeigt gute Strategie) hat schon viele Pharma-Unternehmen in die Krise gestürzt - leider finde ich keine Übersicht über die zukünftigen Projekte (Homepage)
Kompliment für deine sehr gute Analyse! Das ist mit Abstand die beste Analyse, die ich seit langer Zeit gelesen habe (viele Analysten machen sich weniger Gedanken).
Wo ist die Quelle deiner Signalberechnung zu finden?
Unterschiedliche Ergebnisse - wie gewichtest du sie?
Ein Patentablauf (Nachfolger zeigt gute Strategie) hat schon viele Pharma-Unternehmen in die Krise gestürzt - leider finde ich keine Übersicht über die zukünftigen Projekte (Homepage)
Hallo Balou,
tatsächlich dein erster Thread. Es freut mich, dass ich das zufällig mitbekommen habe. Es gefällt mir ausgesprochen gut, wie du an die Sache herangehst. Ich habe inzwischen schon sehr viel zu FRX gelesen und ich denke, es bietet sich hier gerade eine tolle Möglichkeit, in ein hervorragendes Unternehmen einzusteigen. Finanziell steht FRX wirklich Klasse da. Man kann es kaum besser machen. Die Philosophie hinter dem geschäftlichen Erfolg kann mich ebenfalls begeistern. So weit ich das als medizinischer Laie beurteilen kann, stehen die Chancen für die neuen Medikamente sehr gut. Zudem ist man weiter bestrebt, aus der Masse heraus stechende Medikamente zu finden. Dabei stelle ich mir die bisher erzielten Erfolge als sehr hilfreich vor.
Der Kursverlauf erinnert zwar an den Spruch, don’t catch a falling knife, aber niedrigere Kurse sollten hier eher zu weiteren Käufen einladen. Ich für meinen Teil habe begonnen mir schon mal einen Bestand aufzubauen. Noch tiefere Kurse würden mich also derzeit eher freuen.
Bist du denn subscriber bei benchmarkinvesting?
Morningstar war mir bereits bekannt. Ich wusste allerdings nicht, wie viel nützliches Zahlenmaterial man dort zu sehen bekommt. Danke für den Hinweis.
tatsächlich dein erster Thread. Es freut mich, dass ich das zufällig mitbekommen habe. Es gefällt mir ausgesprochen gut, wie du an die Sache herangehst. Ich habe inzwischen schon sehr viel zu FRX gelesen und ich denke, es bietet sich hier gerade eine tolle Möglichkeit, in ein hervorragendes Unternehmen einzusteigen. Finanziell steht FRX wirklich Klasse da. Man kann es kaum besser machen. Die Philosophie hinter dem geschäftlichen Erfolg kann mich ebenfalls begeistern. So weit ich das als medizinischer Laie beurteilen kann, stehen die Chancen für die neuen Medikamente sehr gut. Zudem ist man weiter bestrebt, aus der Masse heraus stechende Medikamente zu finden. Dabei stelle ich mir die bisher erzielten Erfolge als sehr hilfreich vor.
Der Kursverlauf erinnert zwar an den Spruch, don’t catch a falling knife, aber niedrigere Kurse sollten hier eher zu weiteren Käufen einladen. Ich für meinen Teil habe begonnen mir schon mal einen Bestand aufzubauen. Noch tiefere Kurse würden mich also derzeit eher freuen.
Bist du denn subscriber bei benchmarkinvesting?
Morningstar war mir bereits bekannt. Ich wusste allerdings nicht, wie viel nützliches Zahlenmaterial man dort zu sehen bekommt. Danke für den Hinweis.
Trading Spotlight
@kosto,
vielen Dank für die Blumen.
Die Homepage von Forest Labs. ist hier http://www.frx.com/ zu finden.
Meine Berechnungen basieren auf einer Methode von Volker Gelfahrt (ist u.a. Chefredakteur der Aktien-Analyse) und Prof. Dr. Max Otte, die sie in ihrem Buch Investieren statt spekulieren vorstellen. Die ganze Vorgehensweise ist stark von W. Buffet geprägt.
Auf http://www.value-analyse.de/ wird die Methode, vor allem im Forum, diskutiert. Betreiber der Seite sind Volker Gelfahrt und Andreas Droege.
Die Gewichtung der Signale ist für mich nicht so entscheident. Das Gesamtbild muss stimmen. Inzwischen würde ich sogar soweit gehen, dass ich nach einer Stunde zu der Aussgage gelangen können muss, ein Unternehmen ist kaufenswert oder eben nicht. Den Rest der Zeit, den ich für die Anlayse aufwende, geht es nur noch darum diese Aussage abzusichern und den Preis, den ich bereit bin zu bezahlen, zu bestimmen.
Gruß
Balou
vielen Dank für die Blumen.
Die Homepage von Forest Labs. ist hier http://www.frx.com/ zu finden.
Meine Berechnungen basieren auf einer Methode von Volker Gelfahrt (ist u.a. Chefredakteur der Aktien-Analyse) und Prof. Dr. Max Otte, die sie in ihrem Buch Investieren statt spekulieren vorstellen. Die ganze Vorgehensweise ist stark von W. Buffet geprägt.
Auf http://www.value-analyse.de/ wird die Methode, vor allem im Forum, diskutiert. Betreiber der Seite sind Volker Gelfahrt und Andreas Droege.
Die Gewichtung der Signale ist für mich nicht so entscheident. Das Gesamtbild muss stimmen. Inzwischen würde ich sogar soweit gehen, dass ich nach einer Stunde zu der Aussgage gelangen können muss, ein Unternehmen ist kaufenswert oder eben nicht. Den Rest der Zeit, den ich für die Anlayse aufwende, geht es nur noch darum diese Aussage abzusichern und den Preis, den ich bereit bin zu bezahlen, zu bestimmen.
Gruß
Balou
@better,
auch ich habe eine erste Position aufgebaut. Eine derartig umfangreiche Analyse mache ich eigentlich nur, wenn meine Kaufentscheidung bereits gefallen ist.
Ich bin subscriber bei benchmarkinvesting.com und den Motley Fools.
Bei den Fools sind die Betreiber der Seite, Lee Lackey und Rick Sandberg sehr aktiv und posten wöchentlich die aktualisierten Daten des MidCap 400. Auch der Autor des Buches "Trouncing the Dow" Kenneth Lee, der das Verfahren entwickelt und getestet hat, ist dort aktiv. NYB stand übrigens im Sommer 04 ganz weit oben auf der Liste der unterbewerteten Aktien.
Gruß
Balou
auch ich habe eine erste Position aufgebaut. Eine derartig umfangreiche Analyse mache ich eigentlich nur, wenn meine Kaufentscheidung bereits gefallen ist.
Ich bin subscriber bei benchmarkinvesting.com und den Motley Fools.
Bei den Fools sind die Betreiber der Seite, Lee Lackey und Rick Sandberg sehr aktiv und posten wöchentlich die aktualisierten Daten des MidCap 400. Auch der Autor des Buches "Trouncing the Dow" Kenneth Lee, der das Verfahren entwickelt und getestet hat, ist dort aktiv. NYB stand übrigens im Sommer 04 ganz weit oben auf der Liste der unterbewerteten Aktien.
Gruß
Balou
Hallo Balou,
muss man sich das Buch Trouncing the Dow kaufen, oder kann man mit wenigen Worten erklären, wie dieses Bewertungsmodell funktioniert.
Du kennst ja meine anderen amerikanischen Werte. Kommen diese in den Auflistungen von benchmarkinvesting vor und wenn ja, wie werden sie denn gerade bewertet?
Wie sind deine Erfahrungen. Ist benchmarkinvesting sein Geld Wert? Immerhin sind im Jahr 149$ fällig.
Wie sieht es mit Motley Fool aus. Eine Mitgliedschaft ist dort ist, so wie ich das sehe, ja kostenlos. Wird man dafür mit Werbung oder dergleichen beläßtigt? Gibt es einen Hacken?
muss man sich das Buch Trouncing the Dow kaufen, oder kann man mit wenigen Worten erklären, wie dieses Bewertungsmodell funktioniert.
Du kennst ja meine anderen amerikanischen Werte. Kommen diese in den Auflistungen von benchmarkinvesting vor und wenn ja, wie werden sie denn gerade bewertet?
Wie sind deine Erfahrungen. Ist benchmarkinvesting sein Geld Wert? Immerhin sind im Jahr 149$ fällig.
Wie sieht es mit Motley Fool aus. Eine Mitgliedschaft ist dort ist, so wie ich das sehe, ja kostenlos. Wird man dafür mit Werbung oder dergleichen beläßtigt? Gibt es einen Hacken?
Hallo Better,
das Buch zu kaufen würde ich nicht unbedingt empfehlen. Das Verfahren an sich ist auf wenigen Seiten erklärt. Einen sehr großen Anteil nimmt der Statistik-Teil in Anspruch, in dem der Autor bis 1973 zurück belegt, welche Unternehmen man jeweils hätte kaufen müssen und wie sie sich entwickelt haben. Er berücksichtigt dabei die Entwicklung aller DOW-Aktien.
Wenn du mir deine E-Mailadresse ggf. per Boardmail zukommen lässt, kann ich dir das Kapitel 4, wo das Verfahren erklärt wird, zuschicken.
Zu den 149US$: Für die Analyse von Unternehmen habe ich mehr Interesse als Zeit und da bin ich dankbar, wenn mir jemand, der eine ähnliche Anlagestrategie verfolgt wie ich selbst, mir die Vorauswahl ein wenig erleichtet. Außerdem ist es ist schließlich mein Hobby und mein Hobby ist mir diese 149 US$ wert. Man bekommt genau das, was für die Dow30 Werte frei verfügbar ist, jedoch für den kompletten S&P500 Index.
Die Fools sind auch nur im ersten Monat kostenlos, danach sind es 29 US$ im Jahr. Wird bei mir auch unter Ausgaben für`s Hobby verbucht. Sie schicken zwar regelmäßig Info`s per Mail, was man sonst noch so abbonieren kann, aber das stört nicht weiter. Da gehen mir andere Mail Versender wesentlich mehr auf den Senkel
Von deinen Werten habe ich nur 3 gefunden.
MO - Range 44,50 - 73,88
KRB - Range 23,39 - 41,39
NYB - Range 23,51 - 41,33
jeweils in US$
Ich könnte dir die jeweils aktuellen Listen zuschicken, wenn du mich im Gegenzug wissen lässt, falls du dabei auf was Interessantes stösst.
Ich wollte mir als nächstes ACS (Affiliated Computer Services) mal ansehen. Ich habe zwar bislang kaum eine Ahnung was die machen, aber die Zahlen sehen nicht schlecht aus und der Preis scheint derzeit auch zu stimmen. Sie haben für ein Unternehmen, dass IT-Services im weitesten Sinne anbietet, die Jahre 2001 und 2002 erstaunlich unbeschadet überstanden. Umsatzrendite (akt. 12%), Eigenkapitalrendite (akt. 20%), Eigenkaptalquote (akt. 68%), Cash Flow Marge (akt. 12%), alles tendenziell steigend.
Gruß
Balou
das Buch zu kaufen würde ich nicht unbedingt empfehlen. Das Verfahren an sich ist auf wenigen Seiten erklärt. Einen sehr großen Anteil nimmt der Statistik-Teil in Anspruch, in dem der Autor bis 1973 zurück belegt, welche Unternehmen man jeweils hätte kaufen müssen und wie sie sich entwickelt haben. Er berücksichtigt dabei die Entwicklung aller DOW-Aktien.
Wenn du mir deine E-Mailadresse ggf. per Boardmail zukommen lässt, kann ich dir das Kapitel 4, wo das Verfahren erklärt wird, zuschicken.
Zu den 149US$: Für die Analyse von Unternehmen habe ich mehr Interesse als Zeit und da bin ich dankbar, wenn mir jemand, der eine ähnliche Anlagestrategie verfolgt wie ich selbst, mir die Vorauswahl ein wenig erleichtet. Außerdem ist es ist schließlich mein Hobby und mein Hobby ist mir diese 149 US$ wert. Man bekommt genau das, was für die Dow30 Werte frei verfügbar ist, jedoch für den kompletten S&P500 Index.
Die Fools sind auch nur im ersten Monat kostenlos, danach sind es 29 US$ im Jahr. Wird bei mir auch unter Ausgaben für`s Hobby verbucht. Sie schicken zwar regelmäßig Info`s per Mail, was man sonst noch so abbonieren kann, aber das stört nicht weiter. Da gehen mir andere Mail Versender wesentlich mehr auf den Senkel
Von deinen Werten habe ich nur 3 gefunden.
MO - Range 44,50 - 73,88
KRB - Range 23,39 - 41,39
NYB - Range 23,51 - 41,33
jeweils in US$
Ich könnte dir die jeweils aktuellen Listen zuschicken, wenn du mich im Gegenzug wissen lässt, falls du dabei auf was Interessantes stösst.
Ich wollte mir als nächstes ACS (Affiliated Computer Services) mal ansehen. Ich habe zwar bislang kaum eine Ahnung was die machen, aber die Zahlen sehen nicht schlecht aus und der Preis scheint derzeit auch zu stimmen. Sie haben für ein Unternehmen, dass IT-Services im weitesten Sinne anbietet, die Jahre 2001 und 2002 erstaunlich unbeschadet überstanden. Umsatzrendite (akt. 12%), Eigenkapitalrendite (akt. 20%), Eigenkaptalquote (akt. 68%), Cash Flow Marge (akt. 12%), alles tendenziell steigend.
Gruß
Balou
Forest Laboratories, Inc. has added a news release to its
Title: Forest Laboratories, Inc. Reports Diluted Earnings Per Share of $0.70 for 3Q`05
Date: 1/18/2005 8:05:16 AM
Forest Laboratories, Inc.
(NYSE: FRX), an international pharmaceutical manufacturer and marketer, today
reported record revenues and earnings for its fiscal third quarter ended
December 31, 2004.
Net sales for the quarter increased 14% to $795,047,000 from $700,447,000
in the prior year. Sales in the quarter included $560,640,000 for Forest`s
antidepressant franchise which was comprised of $427,118,000 of Lexapro(R)
(escitalopram oxalate), an SSRI indicated for the initial and maintenance
treatment of Major Depressive Disorder and Generalized Anxiety Disorder, and
$129,812,000 of Celexa(R) (citalopram HBr), an SSRI for the treatment of
Depression. Also included this quarter were $3,710,000 of generic citalopram
sold by the Company`s Inwood Division. Antidepressant franchise sales in the
quarter decreased by 5% as compared to last year`s third quarter sales of
$587,892,000 due to the introduction of generic versions of Celexa during the
quarter. Lexapro`s new prescriptions accounted for approximately 74% of the
Company`s antidepressant new prescriptions prior to the approval of generic
versions of Celexa. Sales of Namenda(R), an NMDA receptor antagonist for the
treatment of moderate to severe Alzheimer`s disease, totaled $100,603,000 in
the quarter. Sales of Flumadine (R), an anti-viral, were $34,615,000, which
includes a one-time purchase by the U.S. Government of $33,509,000 due to the
flu vaccine shortage, while earnings from the co-promotion agreement with
Sankyo Pharma for Benicar(R)* and Benicar HCT(TM), antihypertensive therapies,
totaled $22,544,000. This was the first full quarter in which Benicar was
profitable.
Net income in the current quarter increased by 15% to $260,805,000 as
compared to $226,118,000 reported in the third quarter of the prior year.
Diluted earnings per share increased 17% to $0.70 in the current quarter as
compared to $0.60 in last year`s third quarter. Selling, general and
administrative expenses increased 17% to $242,863,000. Research and
development spending increased 53% to $77,393,000 during the quarter and
included a one-time upfront payment to Gedeon Richter Limited for the U.S. and
Canadian rights to RGH-188, a compound being investigated for the treatment of
schizophrenia and bipolar mania.
Nine-month results
Net sales for the nine months ended December 31, 2004 increased 26% to
$2,434,123,000 from $1,925,352,000 in the prior year. Antidepressant sales
totaled $1,856,878,000 for the nine-month period, an increase of 18% over the
prior year`s nine-month antidepressant sales of $1,578,745,000.
Net income for the nine months ended December 31, 2004 increased 33% to
$786,050,000 from net income of $590,392,000 reported in the nine months of
the prior year. Diluted earnings per share increased 33% to $2.09 in the
current year`s first nine months as compared to diluted earnings per share of
$1.57 for last year`s nine months.
Howard Solomon, Chairman and Chief Executive Officer of Forest, said:
"During the quarter our key promoted products continued to exhibit strong
performance. This is the first quarter where generic versions of Celexa have
been in the marketplace and to date the introduction of generics have not had
any meaningful negative impact on the performance of Lexapro nor do we expect
any meaningful impact given physicians` experience with Lexapro, its
differentiated clinical profile and additional indication in Generalized
Anxiety Disorder. While the impact of generic Celexa on our overall business
will be noticeable in the short-term, the continued growth of Lexapro, Namenda
and Benicar and the launches of Campral(R)* and Combunox(TM) will serve to
overcome the loss of Celexa revenues during the coming quarters.
Regarding product development during the quarter, we received Food and
Drug Administration marketing approval for Combunox for the treatment of acute
moderate to severe pain and expect to commence marketing of the product to
physicians this coming March. We also entered into a collaboration agreement
with Gedeon Richter Limited which represents an important pipeline addition of
an anti-psychotic medication that will compliment our existing Central Nervous
System franchise. Our Business Development group continues to evaluate
interesting potential development drug candidates and we anticipate completing
additional collaboration agreements during the coming quarters."
Mr. Solomon continued: "We expect our financial performance for the
remainder of this fiscal year ending March 31, 2005 should result in earnings
per share of approximately $2.60. Regarding our next fiscal year we plan to
offer guidance in conjunction with our fourth fiscal quarter and fiscal year-
end earnings release which will occur in mid-April."
Forest will host a conference call at 10:00 AM EST today to discuss the
results. The conference call will be webcast live beginning at 10:00 AM EST
on the Company`s website at http://www.frx.com and also on the website
http://www.streetevents.com. Please log on to either website at least fifteen
minutes prior to the conference call as it may be necessary to download
software to access the call. A replay of the conference call will be
available until January 31, 2004 at both websites and also by dialing 1-800-
642-1687 (US investors) or +1-706-645-9291 (international investors) passcode
3307809.
Title: Forest Laboratories, Inc. Reports Diluted Earnings Per Share of $0.70 for 3Q`05
Date: 1/18/2005 8:05:16 AM
Forest Laboratories, Inc.
(NYSE: FRX), an international pharmaceutical manufacturer and marketer, today
reported record revenues and earnings for its fiscal third quarter ended
December 31, 2004.
Net sales for the quarter increased 14% to $795,047,000 from $700,447,000
in the prior year. Sales in the quarter included $560,640,000 for Forest`s
antidepressant franchise which was comprised of $427,118,000 of Lexapro(R)
(escitalopram oxalate), an SSRI indicated for the initial and maintenance
treatment of Major Depressive Disorder and Generalized Anxiety Disorder, and
$129,812,000 of Celexa(R) (citalopram HBr), an SSRI for the treatment of
Depression. Also included this quarter were $3,710,000 of generic citalopram
sold by the Company`s Inwood Division. Antidepressant franchise sales in the
quarter decreased by 5% as compared to last year`s third quarter sales of
$587,892,000 due to the introduction of generic versions of Celexa during the
quarter. Lexapro`s new prescriptions accounted for approximately 74% of the
Company`s antidepressant new prescriptions prior to the approval of generic
versions of Celexa. Sales of Namenda(R), an NMDA receptor antagonist for the
treatment of moderate to severe Alzheimer`s disease, totaled $100,603,000 in
the quarter. Sales of Flumadine (R), an anti-viral, were $34,615,000, which
includes a one-time purchase by the U.S. Government of $33,509,000 due to the
flu vaccine shortage, while earnings from the co-promotion agreement with
Sankyo Pharma for Benicar(R)* and Benicar HCT(TM), antihypertensive therapies,
totaled $22,544,000. This was the first full quarter in which Benicar was
profitable.
Net income in the current quarter increased by 15% to $260,805,000 as
compared to $226,118,000 reported in the third quarter of the prior year.
Diluted earnings per share increased 17% to $0.70 in the current quarter as
compared to $0.60 in last year`s third quarter. Selling, general and
administrative expenses increased 17% to $242,863,000. Research and
development spending increased 53% to $77,393,000 during the quarter and
included a one-time upfront payment to Gedeon Richter Limited for the U.S. and
Canadian rights to RGH-188, a compound being investigated for the treatment of
schizophrenia and bipolar mania.
Nine-month results
Net sales for the nine months ended December 31, 2004 increased 26% to
$2,434,123,000 from $1,925,352,000 in the prior year. Antidepressant sales
totaled $1,856,878,000 for the nine-month period, an increase of 18% over the
prior year`s nine-month antidepressant sales of $1,578,745,000.
Net income for the nine months ended December 31, 2004 increased 33% to
$786,050,000 from net income of $590,392,000 reported in the nine months of
the prior year. Diluted earnings per share increased 33% to $2.09 in the
current year`s first nine months as compared to diluted earnings per share of
$1.57 for last year`s nine months.
Howard Solomon, Chairman and Chief Executive Officer of Forest, said:
"During the quarter our key promoted products continued to exhibit strong
performance. This is the first quarter where generic versions of Celexa have
been in the marketplace and to date the introduction of generics have not had
any meaningful negative impact on the performance of Lexapro nor do we expect
any meaningful impact given physicians` experience with Lexapro, its
differentiated clinical profile and additional indication in Generalized
Anxiety Disorder. While the impact of generic Celexa on our overall business
will be noticeable in the short-term, the continued growth of Lexapro, Namenda
and Benicar and the launches of Campral(R)* and Combunox(TM) will serve to
overcome the loss of Celexa revenues during the coming quarters.
Regarding product development during the quarter, we received Food and
Drug Administration marketing approval for Combunox for the treatment of acute
moderate to severe pain and expect to commence marketing of the product to
physicians this coming March. We also entered into a collaboration agreement
with Gedeon Richter Limited which represents an important pipeline addition of
an anti-psychotic medication that will compliment our existing Central Nervous
System franchise. Our Business Development group continues to evaluate
interesting potential development drug candidates and we anticipate completing
additional collaboration agreements during the coming quarters."
Mr. Solomon continued: "We expect our financial performance for the
remainder of this fiscal year ending March 31, 2005 should result in earnings
per share of approximately $2.60. Regarding our next fiscal year we plan to
offer guidance in conjunction with our fourth fiscal quarter and fiscal year-
end earnings release which will occur in mid-April."
Forest will host a conference call at 10:00 AM EST today to discuss the
results. The conference call will be webcast live beginning at 10:00 AM EST
on the Company`s website at http://www.frx.com and also on the website
http://www.streetevents.com. Please log on to either website at least fifteen
minutes prior to the conference call as it may be necessary to download
software to access the call. A replay of the conference call will be
available until January 31, 2004 at both websites and also by dialing 1-800-
642-1687 (US investors) or +1-706-645-9291 (international investors) passcode
3307809.
18.01.2005 20:07:
Forest Labs: Gewinn deutlich angezogen
Forest Laboratories hat den Gewinn im dritten Quartal von 226,12 auf 260,81 Millionen Dollar oder 70 Cents pro Aktie steigern können. Der Umsatz kletterte auf Jahressicht um 14 Prozent auf 795,05 Millionen Dollar. Die Analystenschar hatte laut Thomson First Call einen Gewinn von 68 Cents pro Aktie erwartet. Ein Teil des Anstiegs war laut Unternehmensauskunft allerdings auf unerwartet hohe Umsätze mit dem Anti-Viren-Medikament Flumidine zurückzuführen. Hier hatte man von dem Engpass bei Grippeimpfstoffen profitiert, der in diesem Herbst in den USA herrschte.
Das Unternehmen prognostizierte nun für das Gesamtjahr einen Gewinn von 2,60 Dollar pro Aktie, was den Analystenprognosen entsprach. Die Aktie verliert an der NYSE derzeit 0,95 Prozent auf 41,77 Dollar.
Forest Labs: Gewinn deutlich angezogen
Forest Laboratories hat den Gewinn im dritten Quartal von 226,12 auf 260,81 Millionen Dollar oder 70 Cents pro Aktie steigern können. Der Umsatz kletterte auf Jahressicht um 14 Prozent auf 795,05 Millionen Dollar. Die Analystenschar hatte laut Thomson First Call einen Gewinn von 68 Cents pro Aktie erwartet. Ein Teil des Anstiegs war laut Unternehmensauskunft allerdings auf unerwartet hohe Umsätze mit dem Anti-Viren-Medikament Flumidine zurückzuführen. Hier hatte man von dem Engpass bei Grippeimpfstoffen profitiert, der in diesem Herbst in den USA herrschte.
Das Unternehmen prognostizierte nun für das Gesamtjahr einen Gewinn von 2,60 Dollar pro Aktie, was den Analystenprognosen entsprach. Die Aktie verliert an der NYSE derzeit 0,95 Prozent auf 41,77 Dollar.
An der Börse zählt die Zukunft - die Basis ist da
Wichtig erscheint mir bei dem Ergebnis auch, dass der Rückgang bei Celexa (nur noch 121,8 Mio. Umsatz im akt. Quartal gegenüber 245 Mio. im Vorjahresquartal) kompensiert werden konnte. D.h. der Auslauf des Patentes konnte durch Umsatzsteigerungen bei den übrigen Produkten ausgeglichen werden. Der Anteil, den Celexa zum Umsatz beiträgt, liegt jetzt bei 16,3% gegenüber 35% im Vorjahr.
Gruß
Balou
Gruß
Balou
noch mal ich,
Namenda, das letztes Jahr eingeführte Alzheimer Medikament, konnte seinen Umsatz auf jetzt 100 Mio. fast verdreifachen und trägt inzwischen zu 12,6% (Vorjahr 4,7%) zum Umsatz bei.
Gruß
Balou
Namenda, das letztes Jahr eingeführte Alzheimer Medikament, konnte seinen Umsatz auf jetzt 100 Mio. fast verdreifachen und trägt inzwischen zu 12,6% (Vorjahr 4,7%) zum Umsatz bei.
Gruß
Balou
Laut Earnings Call wurde das Aktienrückkaufprogramm von 20 Mio. Aktien auf 30 Mio. erhöht.
Gerade als deutscher Anleger profitiert man von Rückkäufen mehr, als von Dividendenzahlungen.
Zum ersten steigt hierdurch der Gewinn pro Aktie in Zukunft überproportional und zum zweiten sind die daraus resultierenden Kursgewinne, im Gegensatz zu Dividendenzahlungen, nach einem Jahr steuerfrei.
Gerade als deutscher Anleger profitiert man von Rückkäufen mehr, als von Dividendenzahlungen.
Zum ersten steigt hierdurch der Gewinn pro Aktie in Zukunft überproportional und zum zweiten sind die daraus resultierenden Kursgewinne, im Gegensatz zu Dividendenzahlungen, nach einem Jahr steuerfrei.
Forest Labs` shares dip following Q3
By Val Brickates Kennedy, CBS.MarketWatch.com
Last Update: 5:06 PM ET Jan. 18, 2005
BOSTON (CBS.MW) - Shares of Forest Laboratories Inc. slipped Tuesday after the pharmaceutical company reported fiscal third-quarter results marked by sales growth of 14 percent.
For the quarter ended Dec. 31, 2004, New York-based Forest (FRX: news, chart, profile) said it earned $260.81 million, or 70 cents a share, up from $226.12 million, or 60 cents, earned in the third quarter of fiscal 2004. Sales for the latest quarter came in at $795.05 million, up from the prior year`s $700.45 million.
The average of a poll of analysts surveyed by Thomson First Call had the drugmaker earning 68 cents a share, on average.
On Jan. 4, Forest said it expected to earn about 68 cents a share for the quarter, or 15 percent higher than previously issued estimates. The company added that sales would come in at about $795 million for the quarter.
Forest attributed the boost in part to a $34 million sale of anti-viral drug Flumidine to the U.S. government in the wake of last year`s national shortage of vaccine for flu shots.
Forest also issued financial estimates for fiscal 2005, stating that it now sees earnings per share coming at about $2.60.
The Thomson First Call-derived average earnings forecast also stands at $2.60 for the year ending March 31.
According to analysts at Prudential Financial, Forest`s future performance will depend on growth achieved by its antidepressant Lexapro and by Namenda, a treatment for Alzheimer`s disease.
The Prudential analysts noted that Namenda could face increasing competition in the Alzheimer`s market and that Lexapro`s sales could similarly suffer from the rollout of a generic version of another of Forest`s antidepressants, Celexa.
Forest`s management believes sales growth for Namenda and Lexapro is experiencing "only a temporary lull," Prudential said in a note.
Shares of Forest closed down 0.9 percent at $41.79 on Tuesday.
By Val Brickates Kennedy, CBS.MarketWatch.com
Last Update: 5:06 PM ET Jan. 18, 2005
BOSTON (CBS.MW) - Shares of Forest Laboratories Inc. slipped Tuesday after the pharmaceutical company reported fiscal third-quarter results marked by sales growth of 14 percent.
For the quarter ended Dec. 31, 2004, New York-based Forest (FRX: news, chart, profile) said it earned $260.81 million, or 70 cents a share, up from $226.12 million, or 60 cents, earned in the third quarter of fiscal 2004. Sales for the latest quarter came in at $795.05 million, up from the prior year`s $700.45 million.
The average of a poll of analysts surveyed by Thomson First Call had the drugmaker earning 68 cents a share, on average.
On Jan. 4, Forest said it expected to earn about 68 cents a share for the quarter, or 15 percent higher than previously issued estimates. The company added that sales would come in at about $795 million for the quarter.
Forest attributed the boost in part to a $34 million sale of anti-viral drug Flumidine to the U.S. government in the wake of last year`s national shortage of vaccine for flu shots.
Forest also issued financial estimates for fiscal 2005, stating that it now sees earnings per share coming at about $2.60.
The Thomson First Call-derived average earnings forecast also stands at $2.60 for the year ending March 31.
According to analysts at Prudential Financial, Forest`s future performance will depend on growth achieved by its antidepressant Lexapro and by Namenda, a treatment for Alzheimer`s disease.
The Prudential analysts noted that Namenda could face increasing competition in the Alzheimer`s market and that Lexapro`s sales could similarly suffer from the rollout of a generic version of another of Forest`s antidepressants, Celexa.
Forest`s management believes sales growth for Namenda and Lexapro is experiencing "only a temporary lull," Prudential said in a note.
Shares of Forest closed down 0.9 percent at $41.79 on Tuesday.
Rückgang bei Celexa
Wie sieht es mit Generika Konkurrenz nach Ablauf des Patents aus?
Wie sieht es mit Generika Konkurrenz nach Ablauf des Patents aus?
Ja wenn man das wüsste.
Als Pharmaunternehmen würde ich die Medikamente, deren Patent ausläuft, preislich grundsätzlich immer unter allen Generikaherstellern verkaufen.
Mit der Zeit würden diese bemerken, dass es sich nicht rentiert meine Medikamente nachzumachen. Somit hätte ich auch über den Auslauf meiner Patente hinaus kaum Konkurrenz.
Als Pharmaunternehmen würde ich die Medikamente, deren Patent ausläuft, preislich grundsätzlich immer unter allen Generikaherstellern verkaufen.
Mit der Zeit würden diese bemerken, dass es sich nicht rentiert meine Medikamente nachzumachen. Somit hätte ich auch über den Auslauf meiner Patente hinaus kaum Konkurrenz.
@kosto1929,
der Umsatz bei Celexa hat sich schon jetzt nach dem ersten Quartal, in dem Generika auf dem Markt sind, halbiert.
Damit hat Forest Labs. aber, wenn ich die Informationen aus dem Unternehmen richtig interpretiere, gerechnet und darauf hatte man sich vorbereitet. Wichtiger scheint zu sein, ob die Generika auch für Lexapro, den noch bis mindestens 2008 (Verlängerung bis 2012 beantragt) unter Patentschutz stehenden "Nachfolger" ein Problem werden könnten. Danach sieht es im Moment nicht aus, da die Umsätze bei beiden Antidepressiva (Celexa und Lexapro) zusammen trotz der Generika nur um 5% zurückgegangen sind.
Ob diese, aus meiner Sicht erfreuliche, Entwicklung Bestand haben wird, werden wir in den nächsten Quartalen sehen.
Gruß
Balou
der Umsatz bei Celexa hat sich schon jetzt nach dem ersten Quartal, in dem Generika auf dem Markt sind, halbiert.
Damit hat Forest Labs. aber, wenn ich die Informationen aus dem Unternehmen richtig interpretiere, gerechnet und darauf hatte man sich vorbereitet. Wichtiger scheint zu sein, ob die Generika auch für Lexapro, den noch bis mindestens 2008 (Verlängerung bis 2012 beantragt) unter Patentschutz stehenden "Nachfolger" ein Problem werden könnten. Danach sieht es im Moment nicht aus, da die Umsätze bei beiden Antidepressiva (Celexa und Lexapro) zusammen trotz der Generika nur um 5% zurückgegangen sind.
Ob diese, aus meiner Sicht erfreuliche, Entwicklung Bestand haben wird, werden wir in den nächsten Quartalen sehen.
Gruß
Balou
@Balou
Vielen Dank für die Info.
Wieviel Generikaprodukte für Celexa sind im Umlauf?
Namenda ist ja sehr erfreulich.
Das Risiko dürfte tatsächlich überschaubar sein.
Gruß Kosto
Vielen Dank für die Info.
Wieviel Generikaprodukte für Celexa sind im Umlauf?
Namenda ist ja sehr erfreulich.
Das Risiko dürfte tatsächlich überschaubar sein.
Gruß Kosto
@kosto1929,
bislang sollen es 3 sein. Von Watson Pharma, Novartis und wer der Dritte ist, weiß ich nicht.
Diese Meldung habe ich auch noch gefunden.
----
Forest Labs announced it will launch its own generic version of its Celexa® antidepressant now that 3
other companies have received FDA approvals for their generic versions.
----
Gruß
Balou
bislang sollen es 3 sein. Von Watson Pharma, Novartis und wer der Dritte ist, weiß ich nicht.
Diese Meldung habe ich auch noch gefunden.
----
Forest Labs announced it will launch its own generic version of its Celexa® antidepressant now that 3
other companies have received FDA approvals for their generic versions.
----
Gruß
Balou
Ich glaube ich sollte das EMA-Signal mit in meine Überlegungen einbeziehen (Kurs > EMA13 > EMA 50).
Da ich mich um technische Anlayse nicht kümmere, ist mein timing mal wieder eher bescheiden.
Gruß
Balou
Da ich mich um technische Anlayse nicht kümmere, ist mein timing mal wieder eher bescheiden.
Gruß
Balou
Halber Kurs wäre mir auch recht. Dann bekäme ich die doppelte Anzahl Aktien.
24.01.05 12:26
FRANKFURT (dpa-AFX) - Mit einem aus Fledermaus-Speichel entwickelten Medikament gegen Schlaganfall will das Aachener Biotechnologie-Unternehmen Paion an der Börse Erfolge feiern. Die Zeichnungsfrist für den ersten klassischen Börsengang in diesem Jahr läuft vom 25. Januar bis zum 7. Februar, die Preisspanne für die fünf Millionen Stammaktien liegt zwischen 11 und 14 Euro je Aktie. Das teilte die Paion AG am Montag in Frankfurt mit.
Am 10. Februar soll das Papier voraussichtlich erstmals an der Frankfurter Wertpapierbörse gehandelt werden. Mit dem Börsengang will Paion bis zu 70 Millionen Euro einnehmen. Vergangene Woche wurde von Branchenkreisen über eine Preisspanne von 15 bis 20 Euro spekuliert.
VAMPIRFLEDERMAUS DESMODUS ROTUNDUS
Paion hat gentechnologisch den Wirkstoff Desmoteplase entwickelt, der auf einem Protein im Speichel der Vampirfledermaus Desmodus rotundus basiert. Damit könnten Schlaganfall-Patienten noch neun Stunden nach dem Vorfall behandelt werden, erläuterte Paion- Vorstandschef Wolfgang Söhngen, der das Unternehmen 2000 zusammen mit seiner Frau Mariola gegründet hat. Im Logo findet sich die Fledermaus wieder. "Derzeit gibt es kein vergleichbares Produkt. Wir haben die Chance, aus der Pole Position heraus zu starten."
Für Desmoteplase soll 2007 der Zulassungsantrag gestellt werden. Partner ist der US-Pharmakonzern Forest Lab, der auch die Vermarktungsrechte für Nordamerika innehat. Zusätzlich werden weitere Medikamente zur Behandlung von Schlaganfall und verwandten Erkrankungen entwickelt. "Wir stehen bereits auf mehreren Beinen", sagte Söhngen. "Wir wollen als erste Firma ein integriertes Schlaganfall-Portfolio anbieten."
GELD AUS BÖRSENGANG
Paion (55 Mitarbeiter) erzielte mit 16,6 Millionen Euro in den ersten drei Quartalen 2004 erstmals nennenswerte Umsätze und zwar aus Zahlungen des US-Partners sowie erstmals auch Gewinn. Der Ertrag lag bei 5,3 Millionen Euro. Mindestens bis zur Einführung von Desmoteplase sei aber künftig wieder mit Verlusten zu rechnen, betonte Finanzvorstand Bernhard Hofer.
Das Geld aus dem Börsengang soll in eigene Entwicklungsprojekte und gegebenenfalls auch in Lizenznahmen von anderen Start-Ups, die sich nicht aus eigener Kraft finanzieren können, investiert werden. Die ausgegebenen Aktien stammen komplett aus einer Kapitalerhöhung. Konsortialführer ist die Schweizer Großbank UBS. Schlaganfälle sind nach Angaben von Paion die dritthäufigste Todesursache in den Industrieländern./mi/DP/sk
Quelle: News (c) dpa-AFX Wirtschaftsnachrichten GmbH.
FRANKFURT (dpa-AFX) - Mit einem aus Fledermaus-Speichel entwickelten Medikament gegen Schlaganfall will das Aachener Biotechnologie-Unternehmen Paion an der Börse Erfolge feiern. Die Zeichnungsfrist für den ersten klassischen Börsengang in diesem Jahr läuft vom 25. Januar bis zum 7. Februar, die Preisspanne für die fünf Millionen Stammaktien liegt zwischen 11 und 14 Euro je Aktie. Das teilte die Paion AG am Montag in Frankfurt mit.
Am 10. Februar soll das Papier voraussichtlich erstmals an der Frankfurter Wertpapierbörse gehandelt werden. Mit dem Börsengang will Paion bis zu 70 Millionen Euro einnehmen. Vergangene Woche wurde von Branchenkreisen über eine Preisspanne von 15 bis 20 Euro spekuliert.
VAMPIRFLEDERMAUS DESMODUS ROTUNDUS
Paion hat gentechnologisch den Wirkstoff Desmoteplase entwickelt, der auf einem Protein im Speichel der Vampirfledermaus Desmodus rotundus basiert. Damit könnten Schlaganfall-Patienten noch neun Stunden nach dem Vorfall behandelt werden, erläuterte Paion- Vorstandschef Wolfgang Söhngen, der das Unternehmen 2000 zusammen mit seiner Frau Mariola gegründet hat. Im Logo findet sich die Fledermaus wieder. "Derzeit gibt es kein vergleichbares Produkt. Wir haben die Chance, aus der Pole Position heraus zu starten."
Für Desmoteplase soll 2007 der Zulassungsantrag gestellt werden. Partner ist der US-Pharmakonzern Forest Lab, der auch die Vermarktungsrechte für Nordamerika innehat. Zusätzlich werden weitere Medikamente zur Behandlung von Schlaganfall und verwandten Erkrankungen entwickelt. "Wir stehen bereits auf mehreren Beinen", sagte Söhngen. "Wir wollen als erste Firma ein integriertes Schlaganfall-Portfolio anbieten."
GELD AUS BÖRSENGANG
Paion (55 Mitarbeiter) erzielte mit 16,6 Millionen Euro in den ersten drei Quartalen 2004 erstmals nennenswerte Umsätze und zwar aus Zahlungen des US-Partners sowie erstmals auch Gewinn. Der Ertrag lag bei 5,3 Millionen Euro. Mindestens bis zur Einführung von Desmoteplase sei aber künftig wieder mit Verlusten zu rechnen, betonte Finanzvorstand Bernhard Hofer.
Das Geld aus dem Börsengang soll in eigene Entwicklungsprojekte und gegebenenfalls auch in Lizenznahmen von anderen Start-Ups, die sich nicht aus eigener Kraft finanzieren können, investiert werden. Die ausgegebenen Aktien stammen komplett aus einer Kapitalerhöhung. Konsortialführer ist die Schweizer Großbank UBS. Schlaganfälle sind nach Angaben von Paion die dritthäufigste Todesursache in den Industrieländern./mi/DP/sk
Quelle: News (c) dpa-AFX Wirtschaftsnachrichten GmbH.
Der nächste Blockbuster.
Die Aktien von Novartis gaben 0,61 Prozent auf 57,25 Schweizer Franken nach. Am Markt kursierten Gerüchte, denen zufolge die amerikanische Forest Laboratories auf der Übernahmeliste von Novartis stehen soll. Zudem will der Schweizer Pharmakonzern seine Produktivität deutlich erhöhen und dazu die Entwicklungszeiten neuer Medikamente massiv verkürzen. Entwicklungschef Jörg Reinhardt bestätigte der Zeitung«Die Welt»entsprechende Informationen.
wenn das stimmt nehme ich mein Posting #22 zurück und behaupte jetzt das Gegenteil.
Gruß
Balou
Gruß
Balou
Der nächste Blockbuster steht in den Startlöchern.
Forest Laboratories, Inc.
(NYSE: FRX) today announced the initiation of a phase IIb/III study of
desmoteplase, an investigational novel plasminogen activator, or blood clot
buster, for the treatment of acute ischemic stroke, a condition affecting over
600,000 patients annually in the U.S.
The DIAS2 (Desmoteplase in Acute Ischemic Stroke) study will be a multi-
center, multinational, randomized, parallel-design dose-ranging study of more
than 150 patients to confirm the results of earlier Phase II studies that
demonstrated the potential of desmoteplase to treat acute ischemic stroke
patients up to nine hours after the onset of stroke symptoms, three times
longer than the currently available treatment allows. Because most stroke
patients arrive at the hospital outside the accepted three hour treatment
window, the majority of patients are not eligible for the currently available
treatment. Lengthening that window may expand the number of patients who
could benefit from treatment.
"Preserving brain function and restoring quality of life in patients after
acute ischemic stroke is the goal of effective stroke treatment," says Anthony
Furlan, MD, Medical Director, Cleveland Clinic Foundation and primary
investigator of the DIAS2 and DEDAS (Dose Escalation study of Desmoteplase in
Acute Ischemic Stroke) studies. "The consistent results from two completed
studies of desmoteplase in patients with acute stroke strongly support moving
forward to further assess this potential breakthrough treatment in a large-
scale worldwide trial."
Results of Desmoteplase Confirmed in Second Phase II Study
Results from the recently completed DEDAS study, presented for the first
time on February 4, 2005, as a late-breaker presentation at the 30th
International Stroke Conference in New Orleans, Louisiana, showed trends
indicating that desmoteplase administered intravenously in the time window up
to nine hours after the onset of stroke symptoms:
* Improved blood flow in the damaged area of the brain in patients
treated with 125µg/kg of desmoteplase.
* Improved clinical outcome after 90 days compared to placebo.
The DEDAS study was a multi-center, placebo-controlled, double-blind,
randomized, dose-escalation Phase II trial conducted in 38 patients across 17
hospitals in the U.S. and three hospitals in Europe. This study showed
similar results to the earlier DIAS (Desmoteplase in Acute Ischemic Stroke)
trial, which was published in Stroke in January 2005 and presented at the 29th
International Stroke Conference in February 2004. The former DIAS study used
a similar protocol to DEDAS, with 104 patients across 25 hospitals in Europe,
Australia and Asia. In both these studies, patients with the potential to
benefit from reperfusion therapy were selected using MRI methods to determine
whether they had salvageable tissue and were then administered intravenous
(IV) desmoteplase or placebo in the time window up to nine hours after the
onset of stroke symptoms. Both of these studies were pilot in nature and were
not sized to show statistical differences.
About Desmoteplase
Desmoteplase, first in a new class of plasminogen activators, is a
genetically engineered version of a clot-busting agent found in the saliva of
the vampire bat, Desmodus rotundus. It possesses high fibrin selectivity,
potentially allowing it to dissolve a clot locally without adversely affecting
the blood coagulation system, possibly reducing the risk of intracranial
bleeding (a common risk when administering blood clot-dissolvers) as compared
to other less fibrin-specific plasminogen activators.
Desmoteplase has received fast-track review designation from the U.S. Food
and Drug Administration (FDA) for the treatment of acute ischemic stroke
beyond the three-hour time window. Desmoteplase was licensed to Forest by
PAION GmbH on June 30, 2004. Under the agreement, Forest will be responsible
for regulatory and sales and marketing activities in the U.S. and Canada, and
will have development and marketing rights to other indications of the product
in these territories. PAION retains commercial rights in Europe, Japan, and
the rest of the world.
About Stroke
Stroke is the third leading cause of death in the United States and
Europe, behind heart disease and cancer. According to the American Heart
Association, over 600,000 people in the U.S. fall victim to an ischemic stroke
each year, which comprises approximately 88 percent of all strokes. The
treatment of acute stroke and its serious long-term disabilities currently
present an extensive unmet need.
Ischemic stroke occurs when a blood vessel supplying the brain with oxygen
and nutrients is obstructed by a blood clot. The blockage or rupture of the
vessel results in a lack of blood flow to part of the brain. Deprived of
oxygen, nerve cells in the affected region die within minutes or hours after
the event resulting in loss of function of the part of the body they control.
Ischemic stroke requires emergency treatment to rapidly dissolve or remove the
blood clots in the brain, but many people delay getting treatment.
The only drug currently approved for the treatment of acute ischemic
stroke, tPA (Activase(R)), must be administered within three hours after onset
of stroke symptoms, thus limiting the potential patient population who can
safely benefit from the rapid dissolution of the blood clot and the
reperfusion of blood supply to the affected area of the brain. The majority of
stroke patients arrive at the hospital outside that treatment window. At
present, only eleven percent of ischemic stroke patients are eligible for the
treatment and fewer than four percent actually receive it.
Forest Laboratories, Inc.
(NYSE: FRX) today announced the initiation of a phase IIb/III study of
desmoteplase, an investigational novel plasminogen activator, or blood clot
buster, for the treatment of acute ischemic stroke, a condition affecting over
600,000 patients annually in the U.S.
The DIAS2 (Desmoteplase in Acute Ischemic Stroke) study will be a multi-
center, multinational, randomized, parallel-design dose-ranging study of more
than 150 patients to confirm the results of earlier Phase II studies that
demonstrated the potential of desmoteplase to treat acute ischemic stroke
patients up to nine hours after the onset of stroke symptoms, three times
longer than the currently available treatment allows. Because most stroke
patients arrive at the hospital outside the accepted three hour treatment
window, the majority of patients are not eligible for the currently available
treatment. Lengthening that window may expand the number of patients who
could benefit from treatment.
"Preserving brain function and restoring quality of life in patients after
acute ischemic stroke is the goal of effective stroke treatment," says Anthony
Furlan, MD, Medical Director, Cleveland Clinic Foundation and primary
investigator of the DIAS2 and DEDAS (Dose Escalation study of Desmoteplase in
Acute Ischemic Stroke) studies. "The consistent results from two completed
studies of desmoteplase in patients with acute stroke strongly support moving
forward to further assess this potential breakthrough treatment in a large-
scale worldwide trial."
Results of Desmoteplase Confirmed in Second Phase II Study
Results from the recently completed DEDAS study, presented for the first
time on February 4, 2005, as a late-breaker presentation at the 30th
International Stroke Conference in New Orleans, Louisiana, showed trends
indicating that desmoteplase administered intravenously in the time window up
to nine hours after the onset of stroke symptoms:
* Improved blood flow in the damaged area of the brain in patients
treated with 125µg/kg of desmoteplase.
* Improved clinical outcome after 90 days compared to placebo.
The DEDAS study was a multi-center, placebo-controlled, double-blind,
randomized, dose-escalation Phase II trial conducted in 38 patients across 17
hospitals in the U.S. and three hospitals in Europe. This study showed
similar results to the earlier DIAS (Desmoteplase in Acute Ischemic Stroke)
trial, which was published in Stroke in January 2005 and presented at the 29th
International Stroke Conference in February 2004. The former DIAS study used
a similar protocol to DEDAS, with 104 patients across 25 hospitals in Europe,
Australia and Asia. In both these studies, patients with the potential to
benefit from reperfusion therapy were selected using MRI methods to determine
whether they had salvageable tissue and were then administered intravenous
(IV) desmoteplase or placebo in the time window up to nine hours after the
onset of stroke symptoms. Both of these studies were pilot in nature and were
not sized to show statistical differences.
About Desmoteplase
Desmoteplase, first in a new class of plasminogen activators, is a
genetically engineered version of a clot-busting agent found in the saliva of
the vampire bat, Desmodus rotundus. It possesses high fibrin selectivity,
potentially allowing it to dissolve a clot locally without adversely affecting
the blood coagulation system, possibly reducing the risk of intracranial
bleeding (a common risk when administering blood clot-dissolvers) as compared
to other less fibrin-specific plasminogen activators.
Desmoteplase has received fast-track review designation from the U.S. Food
and Drug Administration (FDA) for the treatment of acute ischemic stroke
beyond the three-hour time window. Desmoteplase was licensed to Forest by
PAION GmbH on June 30, 2004. Under the agreement, Forest will be responsible
for regulatory and sales and marketing activities in the U.S. and Canada, and
will have development and marketing rights to other indications of the product
in these territories. PAION retains commercial rights in Europe, Japan, and
the rest of the world.
About Stroke
Stroke is the third leading cause of death in the United States and
Europe, behind heart disease and cancer. According to the American Heart
Association, over 600,000 people in the U.S. fall victim to an ischemic stroke
each year, which comprises approximately 88 percent of all strokes. The
treatment of acute stroke and its serious long-term disabilities currently
present an extensive unmet need.
Ischemic stroke occurs when a blood vessel supplying the brain with oxygen
and nutrients is obstructed by a blood clot. The blockage or rupture of the
vessel results in a lack of blood flow to part of the brain. Deprived of
oxygen, nerve cells in the affected region die within minutes or hours after
the event resulting in loss of function of the part of the body they control.
Ischemic stroke requires emergency treatment to rapidly dissolve or remove the
blood clots in the brain, but many people delay getting treatment.
The only drug currently approved for the treatment of acute ischemic
stroke, tPA (Activase(R)), must be administered within three hours after onset
of stroke symptoms, thus limiting the potential patient population who can
safely benefit from the rapid dissolution of the blood clot and the
reperfusion of blood supply to the affected area of the brain. The majority of
stroke patients arrive at the hospital outside that treatment window. At
present, only eleven percent of ischemic stroke patients are eligible for the
treatment and fewer than four percent actually receive it.
...forest labs sieht sehr gut aus! charttechnisch dürfte die wende eingeleitet worden sein.
Es könnte aber auch genauso gut, wie in den Jahren zwischen 1991 und 1997, sechs Jahre dauern bis es wieder weitergeht.
Wer weiß das schon.
Wer weiß das schon.
naja dann hat man noch genug zeit jede menge geld nachzuschießen! ...forest labs ist so ein wert in den man bedenkenlos sein geld investieren kann. die erwirtschaften eine super rendite und haben eine extrem gute eigenkapitalquote! über 80%. ein wert mit substanz.
...der aber trotz allem auch nicht ganz billig ist.
Forest Laboratories, Inc. Sets Date and Conference Call for Fiscal 2005 Fourth Quarter Earnings
NEW YORK, April 11 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX), an international manufacturer and marketer of pharmaceutical products, will release its Fiscal 2005 Fourth Quarter financial results before the market opens on Tuesday, April 19, 2005. Later that day, at 10:00 AM EDT, Forest will host a conference call where Kenneth Goodman, President and Chief Operating Officer and Frank Perier, Senior Vice President and Chief Financial Officer, will discuss the financial results and relevant company and industry topics. The conference call will be webcast live beginning at 10:00 AM EDT on the Company`s website http://www.frx.com and also on the website http://www.streetevents.com. Please log on to either website at least fifteen minutes prior to the conference call as it may be necessary to download software to access the call. A replay of the conference call will be available until April 30, 2005 at both websites and also by dialing 1-800-642-1687 (US investors) or +1-706-645-9291 (international investors), ID 5519975.
Except for the historical information contained herein, this release contains forward-looking statements that involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in the Company`s SEC reports, including the Company`s Annual Report on Form 10-K for the fiscal year ended March 31, 2004, and on form 10-Q for the periods ended June 30, 2004, September 30, 2004 and December 31, 2004. Actual results may differ materially from those projected.
NEW YORK, April 11 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX), an international manufacturer and marketer of pharmaceutical products, will release its Fiscal 2005 Fourth Quarter financial results before the market opens on Tuesday, April 19, 2005. Later that day, at 10:00 AM EDT, Forest will host a conference call where Kenneth Goodman, President and Chief Operating Officer and Frank Perier, Senior Vice President and Chief Financial Officer, will discuss the financial results and relevant company and industry topics. The conference call will be webcast live beginning at 10:00 AM EDT on the Company`s website http://www.frx.com and also on the website http://www.streetevents.com. Please log on to either website at least fifteen minutes prior to the conference call as it may be necessary to download software to access the call. A replay of the conference call will be available until April 30, 2005 at both websites and also by dialing 1-800-642-1687 (US investors) or +1-706-645-9291 (international investors), ID 5519975.
Except for the historical information contained herein, this release contains forward-looking statements that involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in the Company`s SEC reports, including the Company`s Annual Report on Form 10-K for the fiscal year ended March 31, 2004, and on form 10-Q for the periods ended June 30, 2004, September 30, 2004 and December 31, 2004. Actual results may differ materially from those projected.
Forest Laboratories, Inc. has added a news release to its Investor Relations website.
Title: Campral(R) is Safe and Well-Tolerated in Long-Term Treatment of Alcohol Dependence According to Results Presented at American Society of Addiction Medicine Conference
Date: 4/15/2005 9:00:27 AM
Forest Laboratories, Inc.
(NYSE: FRX) today announced results of two analyses of several studies
demonstrating that Campral(R) (acamprosate calcium) Delayed-Release Tablets is
safe and well-tolerated in the long-term treatment of alcohol dependence. The
report(1), which was presented today at the 36th Annual Medical-Scientific
Conference of the American Society of Addiction Medicine (ASAM), found Campral
to be safe and well tolerated in studies up to one year, even in patients
taking other drugs such as antidepressants and analgesics.(1)
"These data are important because they show that Campral is safe for
alcohol-dependent patients and even in those who may be taking other
medications," said investigator Richard N. Rosenthal, MD, Professor of
Clinical Psychiatry, Columbia University College of Physicians and Surgeons.
"Unlike older treatments for alcohol dependence, Campral is not metabolized
through the liver. Its favorable long-term safety profile makes it an
attractive new option to help reduce relapse in patients committed to staying
abstinent from alcohol."
The abstract "Acamprosate is Safe and Well-Tolerated in the Long-Term
Treatment of Alcohol Dependence" received this year`s ASAM Medical-Scientific
Program Committee Award for having the highest rating for scientific merit.
The ASAM Conference Program Committee reviewers grant this award to one
abstract each year. The award is based on the presentation of new ideas or
findings of importance to the field of addiction medicine, the methodology
used and clarity of presentation.
Results
The abstract contained data from two key analyses. The first analysis
assessed five year-long, double-blind, placebo-controlled studies (n=1681) to
determine long-term safety and tolerability of Campral in alcohol-dependent
patients, 16 to 70 years of age.(1) In this five-study analysis, patients were
randomized to receive either Campral 1332 mg/day or Campral 1998 mg/day with
counseling, or placebo plus counseling. A second analysis reviewed four
long-term studies and six short term studies (n=3395). The aim of this second
analysis was to evaluate the impact of concomitant medications on the
tolerability profile of Campral versus placebo.
In the first analysis, the overall incidence of spontaneously reported
adverse events was similar between the Campral 1998 mg/day group and the
placebo group.(1) Rates of adverse events for the combined Campral group (1998
mg and 1332 mg) were higher than placebo (59 percent vs 52 percent;
P<0.050).(1) Diarrhea was the only adverse event reported at higher rates than
placebo, occurring in 10 percent of both Campral groups and 6 percent of the
placebo group (P<0.010).(1) The 1998 mg dose is the only dose approved by the
FDA.(2)
In the second analysis, the incidence of adverse events in patients
treated with Campral concomitantly with medications such as antidepressants,
anxiolytics, sedatives, hypnotics, and analgesics, was comparable to that of
patients taking placebo with these concomitant medications.(1)
Overall, in this study, Campral was found to be safe and well-tolerated in
the long-term treatment of alcohol dependence.(1)
About Campral
Campral (acamprosate calcium) Delayed-Release Tablets are FDA-approved for
the maintenance of abstinence from alcohol in patients with alcohol dependence
who are abstinent at treatment initiation.(2) Treatment with Campral should be
part of a comprehensive management program that includes psychosocial
support.(2)
In clinical trials, patients taking Campral demonstrated a higher rate of
complete abstinence, longer time to first drink, and greater percent days
abstinent than those taking placebo.(1) The mechanism of action of Campral in
maintenance of alcohol abstinence is not completely understood. It is believed
to restore the normal chemical balance in the brain, which is disrupted by
chronic heavy drinking.(2)
In the clinical trial program, side effects for Campral were generally
mild with the most frequently reported side effect being diarrhea.(2)
Campral is contraindicated in patients with severe renal impairment
(creatinine clearance less than or equal to 30 mL/min) and requires a dose
reduction in patients with moderate renal impairment (creatinine clearance of
30-50 mL/min).(2)
The recommended dose of Campral is two 333 mg tablets taken three times
daily (1998 mg total daily dose). Treatment with Campral should be initiated
as soon as possible after the period of alcohol withdrawal, when the patient
has achieved abstinence, and should be maintained if the patient relapses.(2)
Campral was developed by Merck Sante s.a.s., subsidiary of Merck KGaA of
Darmstadt, Germany, and licensed to Forest Laboratories for the United States.
Interested parties can get more information on Campral and obtain the
prescribing information by visiting http://www.campral.com or by calling
800-678-1605.
Title: Campral(R) is Safe and Well-Tolerated in Long-Term Treatment of Alcohol Dependence According to Results Presented at American Society of Addiction Medicine Conference
Date: 4/15/2005 9:00:27 AM
Forest Laboratories, Inc.
(NYSE: FRX) today announced results of two analyses of several studies
demonstrating that Campral(R) (acamprosate calcium) Delayed-Release Tablets is
safe and well-tolerated in the long-term treatment of alcohol dependence. The
report(1), which was presented today at the 36th Annual Medical-Scientific
Conference of the American Society of Addiction Medicine (ASAM), found Campral
to be safe and well tolerated in studies up to one year, even in patients
taking other drugs such as antidepressants and analgesics.(1)
"These data are important because they show that Campral is safe for
alcohol-dependent patients and even in those who may be taking other
medications," said investigator Richard N. Rosenthal, MD, Professor of
Clinical Psychiatry, Columbia University College of Physicians and Surgeons.
"Unlike older treatments for alcohol dependence, Campral is not metabolized
through the liver. Its favorable long-term safety profile makes it an
attractive new option to help reduce relapse in patients committed to staying
abstinent from alcohol."
The abstract "Acamprosate is Safe and Well-Tolerated in the Long-Term
Treatment of Alcohol Dependence" received this year`s ASAM Medical-Scientific
Program Committee Award for having the highest rating for scientific merit.
The ASAM Conference Program Committee reviewers grant this award to one
abstract each year. The award is based on the presentation of new ideas or
findings of importance to the field of addiction medicine, the methodology
used and clarity of presentation.
Results
The abstract contained data from two key analyses. The first analysis
assessed five year-long, double-blind, placebo-controlled studies (n=1681) to
determine long-term safety and tolerability of Campral in alcohol-dependent
patients, 16 to 70 years of age.(1) In this five-study analysis, patients were
randomized to receive either Campral 1332 mg/day or Campral 1998 mg/day with
counseling, or placebo plus counseling. A second analysis reviewed four
long-term studies and six short term studies (n=3395). The aim of this second
analysis was to evaluate the impact of concomitant medications on the
tolerability profile of Campral versus placebo.
In the first analysis, the overall incidence of spontaneously reported
adverse events was similar between the Campral 1998 mg/day group and the
placebo group.(1) Rates of adverse events for the combined Campral group (1998
mg and 1332 mg) were higher than placebo (59 percent vs 52 percent;
P<0.050).(1) Diarrhea was the only adverse event reported at higher rates than
placebo, occurring in 10 percent of both Campral groups and 6 percent of the
placebo group (P<0.010).(1) The 1998 mg dose is the only dose approved by the
FDA.(2)
In the second analysis, the incidence of adverse events in patients
treated with Campral concomitantly with medications such as antidepressants,
anxiolytics, sedatives, hypnotics, and analgesics, was comparable to that of
patients taking placebo with these concomitant medications.(1)
Overall, in this study, Campral was found to be safe and well-tolerated in
the long-term treatment of alcohol dependence.(1)
About Campral
Campral (acamprosate calcium) Delayed-Release Tablets are FDA-approved for
the maintenance of abstinence from alcohol in patients with alcohol dependence
who are abstinent at treatment initiation.(2) Treatment with Campral should be
part of a comprehensive management program that includes psychosocial
support.(2)
In clinical trials, patients taking Campral demonstrated a higher rate of
complete abstinence, longer time to first drink, and greater percent days
abstinent than those taking placebo.(1) The mechanism of action of Campral in
maintenance of alcohol abstinence is not completely understood. It is believed
to restore the normal chemical balance in the brain, which is disrupted by
chronic heavy drinking.(2)
In the clinical trial program, side effects for Campral were generally
mild with the most frequently reported side effect being diarrhea.(2)
Campral is contraindicated in patients with severe renal impairment
(creatinine clearance less than or equal to 30 mL/min) and requires a dose
reduction in patients with moderate renal impairment (creatinine clearance of
30-50 mL/min).(2)
The recommended dose of Campral is two 333 mg tablets taken three times
daily (1998 mg total daily dose). Treatment with Campral should be initiated
as soon as possible after the period of alcohol withdrawal, when the patient
has achieved abstinence, and should be maintained if the patient relapses.(2)
Campral was developed by Merck Sante s.a.s., subsidiary of Merck KGaA of
Darmstadt, Germany, and licensed to Forest Laboratories for the United States.
Interested parties can get more information on Campral and obtain the
prescribing information by visiting http://www.campral.com or by calling
800-678-1605.
Campral trägt für die Merck KGaA offensichtlich so wenig zum Umsatz und / oder Gewinn bei, dass die Zahlen in den letzten 5 Geschäftsberichten gar nicht erwähnt werden. Lediglich die FDA-Zulassung in den USA und die daraus resultierenden Lizenzzahlungen seitens FRX (immerhin 27 Mio US$) haben zu einer Notiz im letzten Geschäftsbericht geführt.
Daher sollte man sich von Campral nicht allzuviel erwarten.
Allerdings gibt es eine Reihe von Studien, die belegen, dass das Medikament wirkt und seit 10 Jahren wurde in den USA kein Medikament zur Behandlung von Alkoholabhängigkeit mehr zugelassen. Das wiederrum lässt hoffen.
Hier noch was deutschsprachiges zu Campral :
http://www.merck.de/servlet/PB/show/1350720/Campral_29.07.04…
Gruß
Balou
Daher sollte man sich von Campral nicht allzuviel erwarten.
Allerdings gibt es eine Reihe von Studien, die belegen, dass das Medikament wirkt und seit 10 Jahren wurde in den USA kein Medikament zur Behandlung von Alkoholabhängigkeit mehr zugelassen. Das wiederrum lässt hoffen.
Hier noch was deutschsprachiges zu Campral :
http://www.merck.de/servlet/PB/show/1350720/Campral_29.07.04…
Gruß
Balou
Forest Laboratories revidiert Erwartungen nach unten
Der US-amerikanische Pharmakonzern Forest Laboratories Inc. geht davon aus, dass sein Gewinn im eben abgelaufenen vierten Quartal nicht die vorherigen Unternehmensprognosen erreichen wird. Der Konzern begründete dies am Mittwoch damit, dass seine Handelspartner ihre Bestände zurückfahren.
Demnach erwartet das Unternehmen einen Nettoumsatz in Höhe von 614 Mio. Dollar. Hierbei macht sich vor allem der Absatzrückgang des Antidepressivums Celexa bemerkbar, welches lediglich einen Umsatz von 6 Mio. Dollar generieren konnte. Das Präparat hatte vor allem unter dem Wettbewerbsdruck günstigerer Generika zu leiden.
Forest Laboratories gab ferner bekannt, dass es sein EPS bei nur noch 15 Cents sieht. Dieser Wert beinhaltet einen Sondereffekt in Höhe von 91 Mio. Dollar. Im vierten Quartal des Vorjahres hatte das Unternehmen noch einen Gewinn von 38 Cents je Aktie erwirtschaftet.
Forest Laboratories wird an der NYSE aktuell bei einem Minus von 6,69 Prozent mit 35,45 Dollar gehandelt.
Quelle: FINANZEN.NET
Der US-amerikanische Pharmakonzern Forest Laboratories Inc. geht davon aus, dass sein Gewinn im eben abgelaufenen vierten Quartal nicht die vorherigen Unternehmensprognosen erreichen wird. Der Konzern begründete dies am Mittwoch damit, dass seine Handelspartner ihre Bestände zurückfahren.
Demnach erwartet das Unternehmen einen Nettoumsatz in Höhe von 614 Mio. Dollar. Hierbei macht sich vor allem der Absatzrückgang des Antidepressivums Celexa bemerkbar, welches lediglich einen Umsatz von 6 Mio. Dollar generieren konnte. Das Präparat hatte vor allem unter dem Wettbewerbsdruck günstigerer Generika zu leiden.
Forest Laboratories gab ferner bekannt, dass es sein EPS bei nur noch 15 Cents sieht. Dieser Wert beinhaltet einen Sondereffekt in Höhe von 91 Mio. Dollar. Im vierten Quartal des Vorjahres hatte das Unternehmen noch einen Gewinn von 38 Cents je Aktie erwirtschaftet.
Forest Laboratories wird an der NYSE aktuell bei einem Minus von 6,69 Prozent mit 35,45 Dollar gehandelt.
Quelle: FINANZEN.NET
Forest Laboratories Reports Fiscal Fourth Quarter 2005 Results and Provides Earnings Per Share Guidance for Fiscal 2006
NEW YORK, April 19 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, today reported revenues and earnings for its fiscal fourth quarter and twelve months ended March 31, 2005.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Fourth Quarter Results
Net sales for the quarter decreased 15% to $618,285,000 from $725,080,000 in the prior year`s fourth quarter as a result of the launch of generic equivalents of the Company`s antidepressant Celexa(R) (citalopram HBr). Sales in the current quarter included $406,432,000 for Forest`s antidepressant franchise which was comprised of $399,381,000 of Lexapro(R) (escitalopram oxalate), $6,197,000 of Celexa, and $854,000 of generic citalopram, all selective serotonin reuptake inhibitors (SSRIs). Antidepressant sales in last year`s fourth quarter were $597,493,000 consisting of $351,838,000 of Lexapro and $245,655,000 of Celexa. Sales of Namenda(R), a NMDA receptor antagonist for the treatment of moderate to severe Alzheimer`s disease, were $93,945,000 compared to $34,295,000 in the year ago quarter. Earnings from the co- promotion agreement with Sankyo Pharma for Benicar(R)* and Benicar HCT(TM), antihypertensive therapies, totaled $21,329,000 in the current quarter.
Net income in the current quarter decreased 64% to $52,755,000, or $0.15 per share, as compared to net income of $145,482,000, or $0.38 per share, in the fourth quarter of the prior year. Net income in the quarter was reduced by a one-time special charge of $91 million, or $0.25 per diluted share outstanding, related to taxes associated with $1.239 billion of funds repatriated under the American Jobs Creation Act of 2004. Excluding the one- time charge, earnings per share would have equaled $0.40. Selling, general and administrative expenses decreased 11% from last year`s fourth quarter to $266,459,000. Research and development spending decreased 23% to $61,758,000 during the quarter. Research and development expense in the year ago quarter included upfront payments, including a payment of $25 million to Cypress Bioscience, Inc. for the signing of a development and marketing agreement for milnacipran.
During the quarter Forest repurchased an additional 7.8 million shares under its exiting share repurchase program increasing the program-to-date total to 23.9 million shares. The Company continues to have an additional 6.1 million shares available for repurchase under the existing 30 million share authorization.
Twelve Months Results
Net sales for the fiscal year ended March 31, 2005 increased by 15% to $3,052,408,000 from reported net sales of $2,650,432,000 in fiscal 2004. For the fiscal year, total antidepressant franchise sales were $2,263,310,000 which was comprised of $1,605,296,000 of Lexapro, $653,450,000 of Celexa and $4,564,000 of generic citalopram. Antidepressant franchise sales in fiscal 2004 were $2,176,238,000 which was comprised of $1,088,957,000 of Lexapro and $1,087,281,000 of Celexa. Net sales of Namenda were $332,707,000 for fiscal 2005 versus $45,472,000 for fiscal 2004.
Net income for the twelve months ended March 31, 2005 increased 14% to $838,805,000 from net income of $735,874,000 reported in the prior year. Excluding the one-time $91 million tax charge, net income increased 26% to $929,462,000 from net income of $735,874,000 in the prior year. Selling, general and administrative expenses increased 12% to $993,715,000, while research and development spending increased 19% to $293,659,000 during the year. Diluted earnings per share for fiscal 2005 equaled $2.25 compared to diluted earnings per share of $1.95 in fiscal 2004 and would have been $2.50 excluding the one-time tax charge.
Fiscal 2006 Guidance
Regarding the fiscal year ending March 31, 2006, the first full fiscal year with generic competition for Celexa, the Company expects that fully diluted earnings per share will be approximately $2.30. Forest projects that quarterly earnings per share in the fiscal first quarter of 2006 will be higher than reported earnings per share in the fiscal fourth quarter of 2005 and that quarterly earnings per share will show sequential growth through fiscal 2006. The Company anticipates that net sales for the year will be approximately $50 million lower than the $3,052,408,000 reported in fiscal 2005 but that net revenue, which includes the earnings contribution from Benicar, interest income and other income will increase slightly from reported net revenue in fiscal 2005 of $3,159,639,000.
Forest anticipates continued growth in revenue for its three principal marketed products, Lexapro, Namenda and Benicar, as well as revenue contribution from our two recently launched products, Campral(R) for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation and Combunox(TM) for the short-term management of acute moderate to severe pain. Campral and Combunox will reduce earnings in fiscal 2006 during their launch phase but should contribute to earnings in the future.
Key assumptions supporting the fiscal year forecast include the following: For Lexapro, a projected decline in overall prescription volume for the underlying SSRI/SNRI antidepressant market as a whole of approximately 0.5% and an increase in Lexapro`s total prescription market share from 19.7% at March 31, 2005 to approximately 21.5% at March 31, 2006. This increase in market share along with a price increase should generate Lexapro sales of slightly less than $2 billion.
Namenda is also expected to increase its total prescription volume and benefit from a projected underlying prescription volume growth for the Alzheimer`s market in the 11% range. We anticipate that Namenda sales should be approximately $530,000,000 for the fiscal year.
The Company expects that Benicar will continue to show strong market share gains in fiscal 2006 in a market that will continue to show low double-digit growth. Earnings from Benicar in fiscal 2006 are expected to more than double from fiscal 2005.
For purposes of this forecast the Company is not factoring in any increase in inventory levels at key wholesaler and chain customers but rather anticipating that current levels of approximately two weeks supply will be an average level throughout our fiscal year.
The fiscal 2006 projection includes an approximate 10% increase in selling, general and administrative expenses which would imply spending near the $1.1 billion level. Research and development spending is expected to increase by approximately 25% during the year to $365,000,000 to support numerous clinical development programs and account for potential milestone payments as these programs progress. The estimate does not include upfront payments, milestone or research payments for new products the Company may license during the fiscal year.
Howard Solomon, Chairman and Chief Executive Officer of Forest, said: "Fiscal 2005 demonstrated Forest`s ability to replace lost profits from Celexa by continuing to successfully position our key products, Lexapro, Namenda and Benicar in the marketplace. During the just completed fiscal year, all of our principal promoted products increased their prescription market share and continue to be viewed by physicians as important treatments for their respective disease states. In addition, our business development group successfully completed development agreements with three new partner companies for three new product candidates. We believe that our pipeline includes promising product opportunities and we continue to look forward to entering into additional development agreements."
Mr. Solomon continued: "For fiscal 2006, although quarterly earnings per share comparisons will be more difficult earlier in the year, the Company is on track to generate meaningful earnings per share despite the availability of generic Celexa. During the year our salesforce will focus on maximizing the in-market potential of our currently promoted products while our Research Institute will continue to progress on its development programs."
Mr. Solomon added: "The Lexapro patent infringement case is expected to proceed on schedule with a May 9, 2005 trial date. Forest remains confident in the strength of the Lexapro patent."
Forest Management will host a conference call at 10:00 AM EDT today to discuss the results. The conference call will be webcast live on the Company`s website at http://www.frx.com and also on the website http://www.streetevents.com. Please log on to either website at least fifteen minutes prior to the conference call as it may be necessary to download software to access the call. A replay of the conference call will be available until April 30, 2004 at both websites and also by dialing 1 800 642 1687 (US investors) or +1 706 645 9291 (international investors) passcode 5519975.
About Forest Laboratories and Its Products
Forest Laboratories` growing line of products includes: Lexapro(R) (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda(R) (memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer`s disease; Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar* HCT(R) (olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; Campral(R)* (acamprosate calcium), a glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation in combination with psychosocial support; and Combunox(TM) (Oxycodone HCl and Ibuprofen), an opioid and NSAID combination indicated for the short-term management of acute, moderate to severe pain.
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in the Company`s SEC reports, including the Company`s Annual Report on Form 10-K for the fiscal year ended March 31, 2004, and on form 10-Q for the periods ended June 30, September 30, and December 31, 2004.
* Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral
is a registered trademark under license from Merck Sante s.a.s.,
subsidiary of Merck KGaA, Darmstadt, Germany.
NEW YORK, April 19 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX), an international pharmaceutical manufacturer and marketer, today reported revenues and earnings for its fiscal fourth quarter and twelve months ended March 31, 2005.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Fourth Quarter Results
Net sales for the quarter decreased 15% to $618,285,000 from $725,080,000 in the prior year`s fourth quarter as a result of the launch of generic equivalents of the Company`s antidepressant Celexa(R) (citalopram HBr). Sales in the current quarter included $406,432,000 for Forest`s antidepressant franchise which was comprised of $399,381,000 of Lexapro(R) (escitalopram oxalate), $6,197,000 of Celexa, and $854,000 of generic citalopram, all selective serotonin reuptake inhibitors (SSRIs). Antidepressant sales in last year`s fourth quarter were $597,493,000 consisting of $351,838,000 of Lexapro and $245,655,000 of Celexa. Sales of Namenda(R), a NMDA receptor antagonist for the treatment of moderate to severe Alzheimer`s disease, were $93,945,000 compared to $34,295,000 in the year ago quarter. Earnings from the co- promotion agreement with Sankyo Pharma for Benicar(R)* and Benicar HCT(TM), antihypertensive therapies, totaled $21,329,000 in the current quarter.
Net income in the current quarter decreased 64% to $52,755,000, or $0.15 per share, as compared to net income of $145,482,000, or $0.38 per share, in the fourth quarter of the prior year. Net income in the quarter was reduced by a one-time special charge of $91 million, or $0.25 per diluted share outstanding, related to taxes associated with $1.239 billion of funds repatriated under the American Jobs Creation Act of 2004. Excluding the one- time charge, earnings per share would have equaled $0.40. Selling, general and administrative expenses decreased 11% from last year`s fourth quarter to $266,459,000. Research and development spending decreased 23% to $61,758,000 during the quarter. Research and development expense in the year ago quarter included upfront payments, including a payment of $25 million to Cypress Bioscience, Inc. for the signing of a development and marketing agreement for milnacipran.
During the quarter Forest repurchased an additional 7.8 million shares under its exiting share repurchase program increasing the program-to-date total to 23.9 million shares. The Company continues to have an additional 6.1 million shares available for repurchase under the existing 30 million share authorization.
Twelve Months Results
Net sales for the fiscal year ended March 31, 2005 increased by 15% to $3,052,408,000 from reported net sales of $2,650,432,000 in fiscal 2004. For the fiscal year, total antidepressant franchise sales were $2,263,310,000 which was comprised of $1,605,296,000 of Lexapro, $653,450,000 of Celexa and $4,564,000 of generic citalopram. Antidepressant franchise sales in fiscal 2004 were $2,176,238,000 which was comprised of $1,088,957,000 of Lexapro and $1,087,281,000 of Celexa. Net sales of Namenda were $332,707,000 for fiscal 2005 versus $45,472,000 for fiscal 2004.
Net income for the twelve months ended March 31, 2005 increased 14% to $838,805,000 from net income of $735,874,000 reported in the prior year. Excluding the one-time $91 million tax charge, net income increased 26% to $929,462,000 from net income of $735,874,000 in the prior year. Selling, general and administrative expenses increased 12% to $993,715,000, while research and development spending increased 19% to $293,659,000 during the year. Diluted earnings per share for fiscal 2005 equaled $2.25 compared to diluted earnings per share of $1.95 in fiscal 2004 and would have been $2.50 excluding the one-time tax charge.
Fiscal 2006 Guidance
Regarding the fiscal year ending March 31, 2006, the first full fiscal year with generic competition for Celexa, the Company expects that fully diluted earnings per share will be approximately $2.30. Forest projects that quarterly earnings per share in the fiscal first quarter of 2006 will be higher than reported earnings per share in the fiscal fourth quarter of 2005 and that quarterly earnings per share will show sequential growth through fiscal 2006. The Company anticipates that net sales for the year will be approximately $50 million lower than the $3,052,408,000 reported in fiscal 2005 but that net revenue, which includes the earnings contribution from Benicar, interest income and other income will increase slightly from reported net revenue in fiscal 2005 of $3,159,639,000.
Forest anticipates continued growth in revenue for its three principal marketed products, Lexapro, Namenda and Benicar, as well as revenue contribution from our two recently launched products, Campral(R) for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation and Combunox(TM) for the short-term management of acute moderate to severe pain. Campral and Combunox will reduce earnings in fiscal 2006 during their launch phase but should contribute to earnings in the future.
Key assumptions supporting the fiscal year forecast include the following: For Lexapro, a projected decline in overall prescription volume for the underlying SSRI/SNRI antidepressant market as a whole of approximately 0.5% and an increase in Lexapro`s total prescription market share from 19.7% at March 31, 2005 to approximately 21.5% at March 31, 2006. This increase in market share along with a price increase should generate Lexapro sales of slightly less than $2 billion.
Namenda is also expected to increase its total prescription volume and benefit from a projected underlying prescription volume growth for the Alzheimer`s market in the 11% range. We anticipate that Namenda sales should be approximately $530,000,000 for the fiscal year.
The Company expects that Benicar will continue to show strong market share gains in fiscal 2006 in a market that will continue to show low double-digit growth. Earnings from Benicar in fiscal 2006 are expected to more than double from fiscal 2005.
For purposes of this forecast the Company is not factoring in any increase in inventory levels at key wholesaler and chain customers but rather anticipating that current levels of approximately two weeks supply will be an average level throughout our fiscal year.
The fiscal 2006 projection includes an approximate 10% increase in selling, general and administrative expenses which would imply spending near the $1.1 billion level. Research and development spending is expected to increase by approximately 25% during the year to $365,000,000 to support numerous clinical development programs and account for potential milestone payments as these programs progress. The estimate does not include upfront payments, milestone or research payments for new products the Company may license during the fiscal year.
Howard Solomon, Chairman and Chief Executive Officer of Forest, said: "Fiscal 2005 demonstrated Forest`s ability to replace lost profits from Celexa by continuing to successfully position our key products, Lexapro, Namenda and Benicar in the marketplace. During the just completed fiscal year, all of our principal promoted products increased their prescription market share and continue to be viewed by physicians as important treatments for their respective disease states. In addition, our business development group successfully completed development agreements with three new partner companies for three new product candidates. We believe that our pipeline includes promising product opportunities and we continue to look forward to entering into additional development agreements."
Mr. Solomon continued: "For fiscal 2006, although quarterly earnings per share comparisons will be more difficult earlier in the year, the Company is on track to generate meaningful earnings per share despite the availability of generic Celexa. During the year our salesforce will focus on maximizing the in-market potential of our currently promoted products while our Research Institute will continue to progress on its development programs."
Mr. Solomon added: "The Lexapro patent infringement case is expected to proceed on schedule with a May 9, 2005 trial date. Forest remains confident in the strength of the Lexapro patent."
Forest Management will host a conference call at 10:00 AM EDT today to discuss the results. The conference call will be webcast live on the Company`s website at http://www.frx.com and also on the website http://www.streetevents.com. Please log on to either website at least fifteen minutes prior to the conference call as it may be necessary to download software to access the call. A replay of the conference call will be available until April 30, 2004 at both websites and also by dialing 1 800 642 1687 (US investors) or +1 706 645 9291 (international investors) passcode 5519975.
About Forest Laboratories and Its Products
Forest Laboratories` growing line of products includes: Lexapro(R) (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda(R) (memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer`s disease; Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar* HCT(R) (olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; Campral(R)* (acamprosate calcium), a glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation in combination with psychosocial support; and Combunox(TM) (Oxycodone HCl and Ibuprofen), an opioid and NSAID combination indicated for the short-term management of acute, moderate to severe pain.
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in the Company`s SEC reports, including the Company`s Annual Report on Form 10-K for the fiscal year ended March 31, 2004, and on form 10-Q for the periods ended June 30, September 30, and December 31, 2004.
* Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral
is a registered trademark under license from Merck Sante s.a.s.,
subsidiary of Merck KGaA, Darmstadt, Germany.
Hi allerseits,
hört sich doch ganz gut an. Trotzdem sieht der Chart miserabel aus! Kann mir das jemand erklären. Seht ihr ein Bodenbildung bei 26 €?
Erwäge einen Einstieg. Gestern wurde doch der Gesundheits sektor heraufgestuft wenn ich nicht täusche?!
Grüße!
BF
hört sich doch ganz gut an. Trotzdem sieht der Chart miserabel aus! Kann mir das jemand erklären. Seht ihr ein Bodenbildung bei 26 €?
Erwäge einen Einstieg. Gestern wurde doch der Gesundheits sektor heraufgestuft wenn ich nicht täusche?!
Grüße!
BF
@Mr. BA
Ich denke bei Forest Labs gibt es zwei Gründe für den Kurseinbruch.
Die Ereignisse um Pfizer und Merck, haben dem Kurs (der gesamten Pharma-Industrie) sicher nachhaltig geschadet.
Der Auslauf des Celexa Patentes dürfte ebenfalls eine große Rolle spielen. Forest Labs steht erstmals in seiner Geschichte vor Situation den Patentschutz eines Blockbusters zu verlieren. Mit immerhin ca. 1,2 Mrd Dollar hat Celexa ca. 1/3 des Umsatzes ausgemacht. Da muss auch ein hervoragendes Unternehmen wie FRX erst mal beweisen, dass es das wegstecken kann.
Weiter muss man bedenken, dass FRX momentan auf die Erweiterung von Zulassungen für bereits im Markt befindliche Präparate setzt (vornehmlich Lexapro). Neue Medikamente mit erheblichem Potential sind aktuell keine marktreif, soweit ich informiert bin. Daher sollte man sich auf vielleicht 2 Jahre mit moderatem oder gar keinem Wachstum einstellen.
Dennoch sind sie meiner Meinung nach auch dann noch attraktiv bewertet und sie haben in den vergangenen 10 Jahren beweisen, dass sie ihr Geschäft verstehen. Ich sehe keinen Grund warum sich das ändern sollte.
Gruß
Balou
Ich denke bei Forest Labs gibt es zwei Gründe für den Kurseinbruch.
Die Ereignisse um Pfizer und Merck, haben dem Kurs (der gesamten Pharma-Industrie) sicher nachhaltig geschadet.
Der Auslauf des Celexa Patentes dürfte ebenfalls eine große Rolle spielen. Forest Labs steht erstmals in seiner Geschichte vor Situation den Patentschutz eines Blockbusters zu verlieren. Mit immerhin ca. 1,2 Mrd Dollar hat Celexa ca. 1/3 des Umsatzes ausgemacht. Da muss auch ein hervoragendes Unternehmen wie FRX erst mal beweisen, dass es das wegstecken kann.
Weiter muss man bedenken, dass FRX momentan auf die Erweiterung von Zulassungen für bereits im Markt befindliche Präparate setzt (vornehmlich Lexapro). Neue Medikamente mit erheblichem Potential sind aktuell keine marktreif, soweit ich informiert bin. Daher sollte man sich auf vielleicht 2 Jahre mit moderatem oder gar keinem Wachstum einstellen.
Dennoch sind sie meiner Meinung nach auch dann noch attraktiv bewertet und sie haben in den vergangenen 10 Jahren beweisen, dass sie ihr Geschäft verstehen. Ich sehe keinen Grund warum sich das ändern sollte.
Gruß
Balou
Morning King Pharma`s Revenue Upside Isn`t Sustainable
05.10.05, 10:31 AM ET
Tear Sheet | Chart | News
Morgan Stanley maintained its "equal weight" rating for King Pharmaceuticals (nyse: KG - news - people ) and raised earnings per share estimates for 2005 and 2006. The research firm lifted 2005 earnings estimate to 90 cents per share from 73 cents, and raised the 2006 estimate to 66 cents from 60 cents. Morgan Stanley stressed that although first-quarter earnings were above estimates, it will not upgrade King Pharmaceuticals. "The revenue upside in the quarter came from accounting changes and the timing of R&D spending and thus is not sustainable, in our view. King remains a company in transition, and we continue to believe that management should and will reinvest the upside of the company into growing the business." The research outfit also believes King`s stock has bottomed out and "wouldn’t be surprised if the stock remains in the $9 to $10 range until we get some more clarity on the prospects for Skelaxin or the product pipeline." Morgan Stanley highlighted two hurdles King must face: "The two key challenges we see are competing in the primary care space as a much smaller company than its competition, and competing for new product in-licensing opportunities with the many companies that are pursuing this strategy." In its coverage of specialty pharmaceuticals, Morgan Stanley rates at "overweight": Barr Pharmaceuticals (nyse: BRL - news - people ), Barrier Therapeutics (nasdaq: BTRX - news - people ), Forest Laboratories (nyse: FRX - news - people ) and Sepracor (nasdaq: SEPR - news - people ).
05.10.05, 10:31 AM ET
Tear Sheet | Chart | News
Morgan Stanley maintained its "equal weight" rating for King Pharmaceuticals (nyse: KG - news - people ) and raised earnings per share estimates for 2005 and 2006. The research firm lifted 2005 earnings estimate to 90 cents per share from 73 cents, and raised the 2006 estimate to 66 cents from 60 cents. Morgan Stanley stressed that although first-quarter earnings were above estimates, it will not upgrade King Pharmaceuticals. "The revenue upside in the quarter came from accounting changes and the timing of R&D spending and thus is not sustainable, in our view. King remains a company in transition, and we continue to believe that management should and will reinvest the upside of the company into growing the business." The research outfit also believes King`s stock has bottomed out and "wouldn’t be surprised if the stock remains in the $9 to $10 range until we get some more clarity on the prospects for Skelaxin or the product pipeline." Morgan Stanley highlighted two hurdles King must face: "The two key challenges we see are competing in the primary care space as a much smaller company than its competition, and competing for new product in-licensing opportunities with the many companies that are pursuing this strategy." In its coverage of specialty pharmaceuticals, Morgan Stanley rates at "overweight": Barr Pharmaceuticals (nyse: BRL - news - people ), Barrier Therapeutics (nasdaq: BTRX - news - people ), Forest Laboratories (nyse: FRX - news - people ) and Sepracor (nasdaq: SEPR - news - people ).
Das ruft nach Verbilligen bzw. Einstieg. Das Umfeld sieht gut aus?!
Tief war Anfang-Mitte April.
Meinungen gefragt....
Tief war Anfang-Mitte April.
Meinungen gefragt....
Die Information an sich ist ja nicht neu, aber sie hat es dennoch in sich. Forest Labs hat es in den vergangenen Jahren geschafft, die Patienten von Celexa (ausgelaufener Patentschutz) auf das neue Produkt Lexapro umzustellen. Damit konnte erreicht werden, dass der wegbrechende Celexa Umsatz kompensiert wurde. Wenn jetzt aber, wie aus dem Artikel hevorgeht, die Versicherer nur noch die Kosten für Celexa (bzw. deren Generika) erstatten, könnte das erhebliche Auswirkungen auf den Umsatz von Lexapro haben und Lexapro steht für ca. 60% des Umsatzes von FRX.
Gruß
Balou
------
NEW YORK (AP) -- Shares of Forest Laboratories Inc. fell more than 4 percent on Monday as investors reacted to news that Medicare will not require its insurers to cover Forest`s Lexapro antidepressant.
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Earlier this month, the government agency in charge of Medicare and Medicaid told insurance plans that they only need to cover Forest`s older antidepressant, Celexa, which now faces competition from cheaper generics. The decision did not become public until this morning, according to Pacific Growth Equities analyst Patricia Bank.
Bank said the news means that Forest could have trouble growing its Lexapro franchise, but is not completely unexpected.
"This has already kind of been the trend," Bank said. "I`d kind of look at it as `another nail in the coffin` type of scenario." Lexapro also is immersed in patent litigation as Forest tries to hold back generic competition and Bank noted that the overall antidepressant market has become very mature, making it harder to gain market share.
"We were actually more concerned on the private-payer side," Bank said, explaining that private insurers seem to be mixed on whether to cover the newer Lexapro drug. Lexapro and Celexa share the same active ingredient.
Forest shares recently were trading down $1.70, or 4.2 percent, at $38.94 on the New York Stock Exchange. Its shares have been trading in a 52-week range of $32.46 to $63.54, and are off 13 percent year to date.
Lexapro accounts for about 60 percent of Forest`s revenue, according to Bank. The company has the U.S. rights to the therapy from Danish drug maker H. Lundbeck AS.
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Gruß
Balou
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NEW YORK (AP) -- Shares of Forest Laboratories Inc. fell more than 4 percent on Monday as investors reacted to news that Medicare will not require its insurers to cover Forest`s Lexapro antidepressant.
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Earlier this month, the government agency in charge of Medicare and Medicaid told insurance plans that they only need to cover Forest`s older antidepressant, Celexa, which now faces competition from cheaper generics. The decision did not become public until this morning, according to Pacific Growth Equities analyst Patricia Bank.
Bank said the news means that Forest could have trouble growing its Lexapro franchise, but is not completely unexpected.
"This has already kind of been the trend," Bank said. "I`d kind of look at it as `another nail in the coffin` type of scenario." Lexapro also is immersed in patent litigation as Forest tries to hold back generic competition and Bank noted that the overall antidepressant market has become very mature, making it harder to gain market share.
"We were actually more concerned on the private-payer side," Bank said, explaining that private insurers seem to be mixed on whether to cover the newer Lexapro drug. Lexapro and Celexa share the same active ingredient.
Forest shares recently were trading down $1.70, or 4.2 percent, at $38.94 on the New York Stock Exchange. Its shares have been trading in a 52-week range of $32.46 to $63.54, and are off 13 percent year to date.
Lexapro accounts for about 60 percent of Forest`s revenue, according to Bank. The company has the U.S. rights to the therapy from Danish drug maker H. Lundbeck AS.
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[posting]16.942.404 von Balou2 am 20.06.05 22:32:04[/posting]Murphys Gesetz.
Alles was schiefgehen kann, wird auch schiefgehen.
Alles was schiefgehen kann, wird auch schiefgehen.
Ist zwar nur die Meinung eines "Analysten" und weiß Gott nichts Konkretes, aber immerhin.
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Prudential Equity Group upgraded shares of Forrest Laboratories (nyse: FRX - news - people ) to "overweight" from "neutral weight" and said the company makes an attractive acquisition candidate.
Following the acquisition of Vicuron (nasdaq: MICU - news - people ) by Pfizer (nyse: PFE - news - people ), "questions have arisen about who might be next. One deal that makes great sense to us is a Pfizer-Forest combination," the research firm deduced.
Prudential believes that Forrest`s product roster would fit well with Pfizer`s expiring pipeline. "One of the problems with Pfizer is that the company has significant patent exposure over the next multiyear period, and in some very big categories--like depression and hypertension--Pfizer could become noticeably absent once its products in these areas go off patent.
A Forrest acquisition helps to solve some of Pfizer`s problems." Such substitutions include Forrest`s Lexapro for Zoloft and Benicar for Pfizer`s Norvasc. Prudential`s upgrade was also based on "low investor expectations and a depression market that appears to be stabilizing."
The research firm raised earnings estimates for fiscal 2006 and 2007 to $2.30 and $2.58, respectively, up from $2.29 and $2.51. Prudential has a $44 price target on Forrest Labs and rates Pfizer at "neutral" with a $30 price target.
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Gruß
Balou
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Prudential Equity Group upgraded shares of Forrest Laboratories (nyse: FRX - news - people ) to "overweight" from "neutral weight" and said the company makes an attractive acquisition candidate.
Following the acquisition of Vicuron (nasdaq: MICU - news - people ) by Pfizer (nyse: PFE - news - people ), "questions have arisen about who might be next. One deal that makes great sense to us is a Pfizer-Forest combination," the research firm deduced.
Prudential believes that Forrest`s product roster would fit well with Pfizer`s expiring pipeline. "One of the problems with Pfizer is that the company has significant patent exposure over the next multiyear period, and in some very big categories--like depression and hypertension--Pfizer could become noticeably absent once its products in these areas go off patent.
A Forrest acquisition helps to solve some of Pfizer`s problems." Such substitutions include Forrest`s Lexapro for Zoloft and Benicar for Pfizer`s Norvasc. Prudential`s upgrade was also based on "low investor expectations and a depression market that appears to be stabilizing."
The research firm raised earnings estimates for fiscal 2006 and 2007 to $2.30 and $2.58, respectively, up from $2.29 and $2.51. Prudential has a $44 price target on Forrest Labs and rates Pfizer at "neutral" with a $30 price target.
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Gruß
Balou
[posting]17.040.644 von Balou2 am 28.06.05 21:24:55[/posting]Passt doch.
Wenn allein schon die Produktpipeline für Übernahmespekulationen gut ist, dann dürfte die Zukunft für FRX so schlecht wohl nicht aussehen.
Wenn allein schon die Produktpipeline für Übernahmespekulationen gut ist, dann dürfte die Zukunft für FRX so schlecht wohl nicht aussehen.
Forest Labs hat gestern seine Quartalsergebnisse bekannt gegeben (Zusammenfassung siehe unten).
Der Rückgang der "Celexa" Umsätze ist ja erwartet worden (von 261 Mio. auf gut 4 Mio.) und es kam auch nicht unerwartet, dass FRX dies mit den Umsatzsteigerungen bei Lexapro und Namenda nicht würde kompensieren können. Allerdings ist gegenüber dem Vorquartal mit einem Umsatz von nur 618 Mio. eine deutliche Erholung zu erkennen.
Lexapro legte von 363 Mio. (Jun.04) auf 461 Mio. (Jun.05) und Namenda von 57 Mio. auf 114 Mio. zu. Eine, wie ich finde, erfreuliche Entwicklung.
Man sollte aber nicht vergessen, dass noch zwei Quartale kommen, bei denen im Vorjahr noch nennenswerte Umsätze mit Celexa generiert wurden. Besonders das laufende Quartal wird schwierig, da man letztes Jahr in diesem Quartal bei 856 Mio. Umsatz einen Gewinn von 295 Mio. ausweisen konnte.
Leider fehlen noch Informationen, wie sich die neu eingeführten Präparate Campral und Combunox entwickelt haben. Einige weitere Entwicklungen befinden sich zwar in klinischen Studien, aber mit der Zulassung und Markteinführung ist wohl nicht vor 2007 zu rechnen.
Gruß Balou
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The company (FRX: news, chart, profile) said fiscal first quarter net income eased 6% to $216.6 million or 62 cents a share. Excluding a tax benefit from repatriating foreign funds, profits dropped 22% to $180.2 million for the period, or 52 cents a share. The results were a penny ahead of the average estimate from analysts.
Net revenues dropped 10% to $711.8 million, reflecting a $250 million drop in Celexa sales because of generic competition. Sales of Lexapro, also a depression treatment, reached $461 million, however, topping the Prudential Securities projection at $450 million.
Looking ahead, Forest Labs said that the "overall antidepressant market, our largest market, has shown some recovery in total prescription volume growth rates, which had been negative, and exhibited slightly positive year-over-year growth during each month in the quarter."
The company maintained expectations for earnings per share around $2.30 for the fiscal year ending in March 2006.
Shares declined 96 cents, or 2.3% at $40.69. "Overall, the investment community may be slightly disappointed with (the) results because some had appeared to believe Forest Labs would have a blow-out quarter," Prudential told clients.
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Der Rückgang der "Celexa" Umsätze ist ja erwartet worden (von 261 Mio. auf gut 4 Mio.) und es kam auch nicht unerwartet, dass FRX dies mit den Umsatzsteigerungen bei Lexapro und Namenda nicht würde kompensieren können. Allerdings ist gegenüber dem Vorquartal mit einem Umsatz von nur 618 Mio. eine deutliche Erholung zu erkennen.
Lexapro legte von 363 Mio. (Jun.04) auf 461 Mio. (Jun.05) und Namenda von 57 Mio. auf 114 Mio. zu. Eine, wie ich finde, erfreuliche Entwicklung.
Man sollte aber nicht vergessen, dass noch zwei Quartale kommen, bei denen im Vorjahr noch nennenswerte Umsätze mit Celexa generiert wurden. Besonders das laufende Quartal wird schwierig, da man letztes Jahr in diesem Quartal bei 856 Mio. Umsatz einen Gewinn von 295 Mio. ausweisen konnte.
Leider fehlen noch Informationen, wie sich die neu eingeführten Präparate Campral und Combunox entwickelt haben. Einige weitere Entwicklungen befinden sich zwar in klinischen Studien, aber mit der Zulassung und Markteinführung ist wohl nicht vor 2007 zu rechnen.
Gruß Balou
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The company (FRX: news, chart, profile) said fiscal first quarter net income eased 6% to $216.6 million or 62 cents a share. Excluding a tax benefit from repatriating foreign funds, profits dropped 22% to $180.2 million for the period, or 52 cents a share. The results were a penny ahead of the average estimate from analysts.
Net revenues dropped 10% to $711.8 million, reflecting a $250 million drop in Celexa sales because of generic competition. Sales of Lexapro, also a depression treatment, reached $461 million, however, topping the Prudential Securities projection at $450 million.
Looking ahead, Forest Labs said that the "overall antidepressant market, our largest market, has shown some recovery in total prescription volume growth rates, which had been negative, and exhibited slightly positive year-over-year growth during each month in the quarter."
The company maintained expectations for earnings per share around $2.30 for the fiscal year ending in March 2006.
Shares declined 96 cents, or 2.3% at $40.69. "Overall, the investment community may be slightly disappointed with (the) results because some had appeared to believe Forest Labs would have a blow-out quarter," Prudential told clients.
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[posting]17.287.315 von Balou2 am 20.07.05 17:23:58[/posting]Ich sehe die Sache langfristig als positiv.
Forest Labs Shares Could See `Positive Momentum`
07.26.05, 11:59 AM ET
Forrest Laboratories
Morgan Stanley maintained an "overweight" rating on Forest Laboratories (nyse: FRX - news - people ) after the U.S. Food and Drug Administration rejected an expanded label for the drug company`s Namenda Alzheimer`s treatment. "We think the FDA`s decision is more of a hit to investor sentiment, rather than the actual numbers," Morgan Stanley said.
The FDA issued a non-approvable letter in response to Forest`s supplemental new drug application for Namenda to treat mild Alzheimer`s disease, according to Morgan Stanley. "We are very surprised by the FDA`s action, given our understanding that the FDA`s previous guidance was that only one positive study would be needed to get the approval," the firm said. "As it turns out, the FDA decided not to approve Namenda for mild patients because of two previously disclosed studies that were not statistically significant. This is very confusing, considering that the FDA has approved many CNS [central nervous system] drugs with multiple failed studies."
The research firm lowered the price target on Forest Labs to $49 from $50. "We continue to like the stock and are making no change to our `overweight` rating," it said. "We look forward to the top-line Phase III results for Milnacipran in the fall, which, if positive, should provide some positive momentum to the stock."
As stated in a note published earlier this month, the risks to the stock achieving the price target include growth in the depression category and continued growth of Lexapro with generic Celexa and Cymbalta from Eli Lilly (nyse: LLY - news - people ) on the market as well as continued growth of Namenda and Benicar, Morgan Stanley said. Elsewhere in the specialty pharmaceuticals sector, Morgan Stanley rates the following companies at "overweight": Advanced Medical Optics (nyse: AVO - news - people ), Barrier Therapeutics (nasdaq: BTRX - news - people ) and Sepracor (nasdaq: SEPR - news - people ).
Ich bleib´ erstmal bei 50$ - 49$ ist zu krumm.
07.26.05, 11:59 AM ET
Forrest Laboratories
Morgan Stanley maintained an "overweight" rating on Forest Laboratories (nyse: FRX - news - people ) after the U.S. Food and Drug Administration rejected an expanded label for the drug company`s Namenda Alzheimer`s treatment. "We think the FDA`s decision is more of a hit to investor sentiment, rather than the actual numbers," Morgan Stanley said.
The FDA issued a non-approvable letter in response to Forest`s supplemental new drug application for Namenda to treat mild Alzheimer`s disease, according to Morgan Stanley. "We are very surprised by the FDA`s action, given our understanding that the FDA`s previous guidance was that only one positive study would be needed to get the approval," the firm said. "As it turns out, the FDA decided not to approve Namenda for mild patients because of two previously disclosed studies that were not statistically significant. This is very confusing, considering that the FDA has approved many CNS [central nervous system] drugs with multiple failed studies."
The research firm lowered the price target on Forest Labs to $49 from $50. "We continue to like the stock and are making no change to our `overweight` rating," it said. "We look forward to the top-line Phase III results for Milnacipran in the fall, which, if positive, should provide some positive momentum to the stock."
As stated in a note published earlier this month, the risks to the stock achieving the price target include growth in the depression category and continued growth of Lexapro with generic Celexa and Cymbalta from Eli Lilly (nyse: LLY - news - people ) on the market as well as continued growth of Namenda and Benicar, Morgan Stanley said. Elsewhere in the specialty pharmaceuticals sector, Morgan Stanley rates the following companies at "overweight": Advanced Medical Optics (nyse: AVO - news - people ), Barrier Therapeutics (nasdaq: BTRX - news - people ) and Sepracor (nasdaq: SEPR - news - people ).
Ich bleib´ erstmal bei 50$ - 49$ ist zu krumm.
Form 10-Q for FOREST LABORATORIES INC
8-Aug-2005
Quarterly Report
MANAGEMENT`S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
(Dollar amounts in thousands)
The decline in revenues for the quarter ended June 2005 as compared with June 2004, resulted from the loss of Celexa sales to generic competition. Sales of Celexa were $261,053 in the June 2004 quarter compared with $4,155 in the current period for both the brand and generic combined. Offsetting this reduction in revenue was strong growth in Lexapro and Namenda sales, as well as co-promotion income earned on Benicar. We had not earned any co-promotion income in the June 2004 quarter.
During the quarter, we received the results of a recently completed placebo-controlled proof of concept study of neramexane in the treatment of moderate to severe Alzheimer`s disease. The study showed sufficient clinical activity, safety and tolerability for us to continue development of the compound. In July 2005, we received a non-approvable letter from the Food and Drug Administration (FDA) in response to our supplemental New Drug Application (sNDA) to expand the indication of Namenda to include mild Alzheimer`s disease. The FDA accepted the sNDA for review in November 2004. Upon completing its review, the FDA acknowledged that it had informed us that a single positive study in patients with mild to moderate Alzheimer`s disease would be adequate to support extending Namenda`s claim to include mild patients. The FDA further acknowledged that the six-month, U.S. mild to moderate study which reached statistical significance at the required primary endpoints was such a study. Nevertheless, the FDA decided not to approve Namenda for mild patients based upon this single positive study in light of two previously disclosed, additional studies of Namenda in patients with mild to moderate Alzheimer`s disease - a study of Namenda monotherapy conducted by H. Lundbeck A/S in Europe and a combination study conducted by Forest in the U.S. with Namenda administered to patients already taking an acetylcholinesterase inhibitor. In both of these studies, which were included in the sNDA filing, Namenda performed numerically better than placebo; however, statistical significance was not reached at the primary endpoints. In all three studies, Namenda was found to be well tolerated. We plan to meet with the FDA shortly to further discuss the non-approvable letter.
During fiscal 2005, our Board of Directors authorized a share repurchase program for up to 30 million shares of common stock (the 2005 Repurchase Program), of which approximately 6,100,000 shares remained to be purchased during the current fiscal year. As of May 11, 2005, all of these shares were repurchased, completing the program. In May 2005, our Board of Directors authorized a new share repurchase program for up to 25 million shares of common stock (the 2006 Repurchase Program). As of June 30, 2005, 2,400,000 shares have been repurchased under this program and we continue to have authority to purchase up to an additional 22,600,000 shares.
During the fourth quarter of fiscal 2005, we repatriated $1,238,900 in qualifying dividends pursuant to the American Jobs Creation Act of 2004. We intend to utilize the repatriated funds pursuant to a qualified domestic investment plan which we have adopted. This repatriation was the maximum dividend amount allowed and resulted in a one-time tax charge of $90,657. In the current quarter, we reversed $36,414 of this charge based on recently issued U.S. Treasury Department guidance. The originally enacted law did not specifically address whether the deduction applied to the required tax gross-up related to the dividend. In May 2005, the U.S. Treasury Department clarified that the dividend received deduction does in fact apply to the tax gross-up amount and accordingly we were allowed to reverse the $36,414 million in the current quarter. The impact of such reversal, was to increase our diluted earnings per share in the June quarter by $0.10 per share.
Financial Condition and Liquidity
Net current assets increased by $91,691 during the current period from March 31, 2005. During the current quarter, approximately 6.1 million shares of common stock were repurchased pursuant to the 2005 Repurchase Program authorized by our Board of Directors in fiscal 2005, at various prices totaling $217,146, completing that program. In May 2005, our Board of Directors approved the 2006 Repurchase Program, which authorized the repurchase of up to 25 million additional shares. In order to fund these share repurchase programs, as longer term investments matured they are being used either to fund the purchase of common stock or shifted to shorter term investments, in anticipation of further common stock repurchases. During the current quarter, the share repurchase programs were funded with cash generated from normal operating activities and supplemented by maturing investments. As of June 30, 2005 we had repurchased 2.4 million shares pursuant to the 2006 Repurchase Program at various prices totaling $93,816 and we continue to have authorization to purchase an additional 22.6 million shares under this program. In total, cash and marketable securities
- both short-term and long-term - decreased by $139,409 during the current period. Trade accounts receivable increased due to strong sales of our principal branded products, partially offset by lower sales of Celexa due to generic competition, while other accounts receivable decreased due to a payment from Sankyo Pharma for our co-promotion of Benicar. The increase in raw materials was primarily due to increased levels of Lexapro inventory to meet higher demand. Work in process and finished goods inventories decreased during the period primarily due to Lexapro and Namenda, as wholesalers brought their inventories to more normal levels - approximately two and a half to three weeks as compared with the two weeks they were holding at March 31, 2005. We believe that our inventory levels are adequate to support future demand. Other current assets increased due principally to the renewal of our insurance policies, particularly product liability insurance, which are paid in full at the time of renewal and expensed over the course of the year. The changes in accounts payable, particularly the timing of raw material receipts and payments, and accrued expenses were due to normal ongoing operating activities.
Property, plant and equipment increased primarily due to the continuing expansion of our facilities in order to meet future product demands. In Jersey City, we are leasing an additional floor of office space totaling 36,000 square feet to accommodate growth in our Research Institute. On Long Island, we are adding 37,000 square feet to our sales training facility. In fiscal 2005 we purchased a 40,000 square foot facility in St. Louis, which is being used as a data center and we have begun construction on a 141,000 square foot addition to our current distribution facility, which will bring the total capacity of our warehouse and distribution center to approximately 475,000 square feet. In Ireland, we are refurbishing a 90,000 square foot plant which will provide redundancy for the manufacture of Lexapro and Namenda and additional capacity for future products. Further property expansions and acquisitions are planned in the future to meet the needs from increased sales and related production, warehousing and distribution, sales training and for products under development. During the current quarter, we also continued to make technology investments to expand our principal operating systems to include salesforce and warehouse management applications.
During fiscal 2005 our Board of Directors approved the 2005 Repurchase Program which authorized the purchase of up to 30 million shares of common stock. We purchased 23,930,400 shares on the open market at an average price of $42.06 per share during fiscal 2005, and completed the balance of the program in May 2005. The remainder of the shares were purchased at an average price of $35.79, bringing the total cost of the 30 million shares to $1,224,192. On May 10, 2005 our Board of Directors authorized the 2006 Repurchase Program for up to 25 million shares. As of June 30, 2005, 2,400,000 shares have been repurchased under this program and we continue to have authority to purchase up to an additional 22,600,000 shares. We expect to make additional purchases, from time to time in the open market, depending on market conditions.
Management believes that current cash levels, coupled with funds to be generated by ongoing operations, will continue to provide adequate liquidity to facilitate potential acquisitions of products, payment of achieved milestones, capital investments and the 2006 Repurchase Program.
Results of Operations
Net sales decreased $107,743 to $674,653, a 14% decrease from the same period last year, primarily due to generic competition for Celexa. Sales of Celexa were $261,053 in the June 2004 quarter compared with $4,155 in the current period for both the brand and generic combined. Offsetting the losses from Celexa were strong sales of Lexapro and Namenda. Lexapro, our largest product, with sales of $461,072, contributed $97,200 to the net sales change, of which $78,108 was due to volume and $19,092 was due to price. As of June 30, 2005 Lexapro achieved a 20.0% share of total prescriptions in the selective serotonin reuptake inhibitor (SSRI) market. Lexapro has patent protection until 2009 and we have applied for an extension to 2012. In fiscal 2004, we received notification from generic manufacturers that they had filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV Certification with the FDA for a generic equivalent to Lexapro. We believe that our patents on Lexapro are valid. Forest has commenced an action for patent infringement against the third party ANDA filers with a trial date in December 2005.
Sales of Namenda, an N-methyl-D-aspartate (NMDA) receptor antagonist for the treatment of moderate to severe Alzheimer`s disease, launched in March 2004, increased $57,336 as compared to the same period last year to $114,704 for the current quarter. Namenda is the first product indicated for the treatment of moderate to severe Alzheimer`s disease and has generated significant new prescriptions in the retail and long-term care markets. Namenda achieved a 27.3% share of total prescriptions in the Alzheimer`s market as of June 30, 2005. In July 2005, we received a non-approvable letter from the FDA in response to our sNDA to expand the indication of Namenda to include mild Alzheimer`s disease - a study of Namenda monotherapy conducted by H. Lundbeck A/S in Europe and a combination study conducted by Forest in the U.S. with Namenda administered to patients already taking an acetylcholinesterase inhibitor. In both of these studies, which were included in the sNDA filing, Namenda performed numerically better than placebo; however, statistical significance was not reached at the primary endpoints. In all three studies, Namenda was found to be well tolerated. We plan to meet with the FDA shortly to further discuss the non-approvable letter. We anticipate Namenda continuing positive growth through fiscal 2006.
Sales of Campral, which was launched in the fourth quarter of fiscal 2005, amounted to $4,324. Campral is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Sales of Combunox, also launched in the fourth quarter of fiscal 2005, amounted to $58. Combunox, which is for the treatment of acute, moderate to severe pain, had a slower than anticipated uptake at launch due its status as a schedule II controlled substance which initially hinders retail stocking at the pharmacy level. Tiazac sales declined $9,885 from last year due primarily to generic competition. The remainder of the net sales change for the period was due principally to volume fluctuations of our older non-promoted product lines.
Contract revenue for the current quarter was $26,269 compared to $2,252 in the same period last year primarily due to co-promotion income from our co-marketing agreement with Sankyo Pharma for Benicar of $24,267. Under the terms of the agreement, Forest has been co-promoting Benicar since May 2003 and is entitled to a share of the product profits (as defined) from the point the product becomes cumulatively profitable. Benicar became cumulatively profitable during the second quarter of fiscal 2005.
Other income for the current quarter increased over the same period last year primarily due to higher interest income received on funds available for investment resulting from more favorable rates of return.
Cost of sales as a percentage of net sales increased to 23.54% for the current quarter as compared to 22.65% for the same period last year, primarily due to product mix, particularly the mix between branded and generic Tiazac.
Selling, general and administrative expenses increased $29,168 in the current quarter as compared to the same period last year due in large measure to the activities of our salesforce and additional product license amortization expense on our recently launched products.
Research and development expense decreased $28,890 in the current quarter primarily due to the payment to PAION GmbH in the same period last year for the U.S. and Canadian rights to desmoteplase, a compound being investigated for the treatment of acute ischemic stroke. Research and development expense also reflects the following developments:
� During the quarter, we received the results of a recently completed placebo-controlled proof of concept study of neramexane in the treatment of moderate to severe Alzheimer`s disease. The study showed sufficient clinical activity, safety and tolerability for us to continue development of the compound.
� In July 2005, we received a non-approvable letter from the FDA in response to our sNDA to expand the indication of Namenda to include mild Alzheimer`s disease. The FDA accepted the sNDA for review in November 2004. Upon completing its review, the FDA acknowledged that it had informed us that a single positive study in patients with mild to moderate Alzheimer`s disease would be adequate to support extending Namenda`s claim to include mild patients. The FDA further acknowledged that the six-month, U.S. mild to moderate study which reached statistical significance at the required primary endpoints was such a study. Nevertheless, the FDA decided not to approve Namenda for mild patients based upon this single positive study in light of two previously disclosed, additional studies of Namenda in patients with mild to moderate Alzheimer`s disease - a study of Namenda monotherapy conducted by H. Lundbeck A/S in Europe and a combination study conducted by Forest in the U.S. with Namenda administered to patients already taking an acetylcholinesterase inhibitor. In both of these studies, which were included in the sNDA filing, Namenda performed numerically better than placebo; however, statistical significance was not reached at the primary endpoints. In all three studies, Namenda was found to be well tolerated. We plan to meet with the FDA shortly to further discuss the non-approvable letter.
� In November 2004, Forest reported on the development progress of lercanidipine, a calcium channel blocker (CCB), being investigated for the treatment of hypertension. In August 2002, an approvable letter was received from the FDA seeking additional data related to the proposed dosing regimen. In response to the request, we conducted an eight week Phase II pilot study in order to assess the clinical efficacy profile of lercanidipine in a new modified release formulation. The preliminary study results indicated that this modified release version of lercanidipine was associated with a clinically relevant reduction in blood pressure, but did not meet all the pre-set criteria for dose response across the range of doses studied. Lercanidipine treatment was well tolerated in this study. We are evaluating additional alternative extended release formulations and considering future development activities.
� During the third quarter of fiscal 2005, Forest entered into a collaboration agreement with Gedeon Richter Limited for the North American rights to RGH-188, a compound which is being developed for the treatment of schizophrenia, bipolar mania and other psychiatric conditions.
� During the second quarter of fiscal 2005, Forest entered into a collaboration agreement with Glenmark Pharmaceuticals S.A. for the North American development and marketing of GRC 3886, a PDE4 inhibitor which will be developed for the treatment of asthma and COPD. In March 2005, as a result of a successfully completed Phase I single and multiple dose study in the U.K., a milestone payment was made to Glenmark pursuant to the terms of the collaboration agreement.
� During the first quarter of fiscal 2005, we entered into an agreement with PAION GmbH for the development and marketing of desmoteplase, a novel drug currently in Phase III clinical studies for the treatment of acute ischemic stroke.
� During the fourth quarter of fiscal 2004, Forest entered into two licensing agreements; the first with Cypress Bioscience, Inc. for the development and marketing of milnacipran, which is currently in Phase III development as a treatment for fibromyalgia syndrome. We expect to have the results of the first Phase III study of milnacipran in fibromyalgia patients in late September 2005. The second was a development agreement with ChemoCentryx, Inc. for novel therapeutics for autoimmune and inflammatory diseases.
The effective tax rate decreased to 5% in the current quarter as compared to 21% in the same period last year primarily due to a one-time reversal of $36,414 related to the March 2005 charge of $90,657 for the repatriation of dividends pursuant to the American Jobs Creation Act of 2004. Excluding this impact, the effective tax rate would have been 21% and is lower than the U.S. statutory tax rate due to the proportion of earnings generated in lower-taxed foreign jurisdictions versus the United States. These earnings include manufacturing and development income from our operations in Ireland, which are taxed at 10% through 2010 and at 12.5% thereafter.
On October 22, 2004, the American Jobs Creation Act of 2004 (the Act) was signed into law. The Act contains numerous changes to existing tax laws, including both domestic and foreign tax incentives. One of the key provisions of the Act, new Internal Revenue Code Section 965, includes a temporary incentive for U.S. multinationals to repatriate foreign earnings by providing an elective 85% dividends received deduction for certain cash dividends from controlled foreign corporations. The provision is effective for dividends paid during the taxable year beginning before the date of enactment or the first taxable year beginning on or after the date of enactment. Moreover, the dividends must be invested in the United States under a domestic reinvestment plan approved by senior management and, subsequently, the board of directors. The provision contains a non-exclusive list of examples of permitted uses of the funds which include funding of worker hiring and training, infrastructure, research and development, capital investment and the financial stabilization of the corporation for purposes of job retention and creation. The dividends subject to the dividend received deduction must not exceed the greater of $500,000 or the earnings reported on the company`s financial statements pursuant to Accounting Principles Board Opinion No. 23 as permanently invested earnings for financial statements certified on or before June 30, 2003. Forest, upon satisfying the U.S. investment criteria and other requirements under the Act, as well as evaluating the guidance provided by the U.S. Treasury Department, executed such a qualifying repatriation in the amount of $1,238,900, the maximum dividend amount for which the special deduction under the Act may be claimed. The resulting additional U.S. tax of $90,657 with respect to such repatriation was provided for in our fiscal 2005 income tax expense. In the current quarter, we reversed $36,414 of this accrual based on recently issued U.S. Treasury Department guidance. Since the originally enacted law did not specifically address whether the deduction applied to the required tax gross-up related to the dividend as of the date the financial statements were prepared for the March 2005 quarter, Forest accrued the tax assuming the deduction did not apply which represented an additional $36 million of tax. In May the U.S. Treasury Department clarified that the dividend received deduction does in fact apply to the tax gross-up amount and accordingly we were allowed to reverse the $36 million in the current quarter.
We expect to continue our profitability in the current fiscal year with continued growth in our principal promoted products.
Inflation has not had a material effect on our operations for the periods presented.
Critical Accounting Policies
The following accounting policies are important in understanding our financial condition and results of operations and should be considered an integral part of the financial review. Refer to the notes to the consolidated financial statements for additional policies.
Estimates and Assumptions
The preparation of financial statements in conformity with generally accepted accounting principles requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and of revenues and expenses during the reporting period. Estimates are made when accounting for sales allowances, returns, rebates and other pricing adjustments, depreciation, amortization and certain contingencies. Forest is subject to risks and uncertainties, which may include but are not limited to competition, federal or local legislation and regulations, litigation and overall changes in the healthcare environment that may cause actual results to vary from estimates. We review all significant estimates affecting the financial statements on a recurring basis and record the effect of any adjustments when necessary. Certain of these risks, uncertainties and assumptions are discussed further under the section entitled "Forward Looking Statements".
Revenue Recognition
Revenues are recorded in the period the merchandise is shipped. As is typical in the pharmaceutical industry, gross product sales are subject to a variety of deductions, primarily representing rebates and discounts to government agencies, wholesalers and managed care organizations. These deductions represent estimates of the related liabilities and, as such, judgment is required when estimating the impact of these sales deductions on gross sales for a reporting period. If estimates are not representative of actual settlement, results could be materially affected. Provisions for estimated sales allowances, returns, rebates and other pricing adjustments are accrued at the time revenues are recognized as a direct reduction of such revenue.
The accruals are estimated based on available information, including third party data, regarding the portion of sales on which rebates and discounts can be earned, adjusted as appropriate for specific known events and the prevailing contractual discount rate. Provisions are reflected either as a direct reduction to accounts receivable or, to the extent that they are due to entities other than customers, as accrued expense. Adjustments to estimates are recorded when customer credits are issued or payments are made to third parties.
The sensitivity of estimates can vary by program and type of customer. However, estimates associated with Medicaid and contract rebates are most at risk for adjustment because of the extensive time delay between the recording of the accrual and its ultimate settlement, an interval that can range up to one year. Because of this time lag, in any given quarter, adjustments to actual may incorporate revisions of prior quarters.
Provisions for Medicaid and contract rebates during a period are recorded based upon the actual historical experience ratio of rebates paid and actual prescriptions written. The experience ratio is applied to the period`s sales to determine the rebate accrual and related expense. This experience ratio is evaluated regularly to ensure that the historical trends are as current as practicable. As appropriate, we will adjust the ratio to more closely match the current experience or expected future experience. In assessing this ratio, we consider current contract terms, such as the effect of changes in formulary status, discount rate and utilization trends. Periodically, the accrual is adjusted based upon actual payments made for rebates. If the ratio is not indicative of future experience, results could be affected. Rebate accruals for Medicaid were $52,729 at June 30, 2005 and $58,026 at June 30, 2004. Commercial discounts and other rebate accruals were $53,902 at June 30, 2005 and $103,733 at June 30, 2004. These and other rebate accruals are established in the period the related revenue was recognized, resulting in a reduction to sales and the establishment of a liability, which is included in accrued expenses.
The following table summarizes the quarterly activity in the accounts related to accrued rebates, sales returns and discounts (In thousands):
June 30, 2005 June 30, 2004
$171,119 $266,209
Beginning balance
56,818 50,380
Provision for rebates ( 61,233) ( 74,233)
Settlements ( 4,415) ( 23,853)
6,540 8,599
Provision for returns ( 7,601) ( 6,950)
Settlements ( 1,061) 1,649
106,890 95,465
Provision for chargebacks and discounts ( 101,571) ( 95,503)
Settlements 5,319 ( 38)
$170,962 $243,967
Ending balance
Deductions for chargebacks (primarily discounts to group purchasing organizations and federal government agencies) closely approximate actual as these deductions are settled generally within 2-3 weeks of incurring the liability.
Forest`s policy relating to the supply of inventory at wholesalers is to maintain stocking levels of up to three weeks and to keep monthly levels consistent from year to year, based on patterns of utilization. We have historically closely monitored wholesale customer stocking levels by purchasing information directly from customers and by obtaining other third party information. Unusual or unexpected variations in buying patterns or utilizations are investigated.
Sales incentives are generally given in connection with a new product launch. These sales incentives are recorded as a reduction of revenues and are based on terms fixed at the time goods are shipped. New product launches may result in expected temporary increases in wholesaler inventories, which as described above, are closely monitored and have not resulted in increased product returns.
Forward Looking Statements
Except for the historical information contained herein, the Management Discussion and other portions of this Form 10-Q contain forward looking statements that involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in our filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended March 31, 2005.
8-Aug-2005
Quarterly Report
MANAGEMENT`S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
(Dollar amounts in thousands)
The decline in revenues for the quarter ended June 2005 as compared with June 2004, resulted from the loss of Celexa sales to generic competition. Sales of Celexa were $261,053 in the June 2004 quarter compared with $4,155 in the current period for both the brand and generic combined. Offsetting this reduction in revenue was strong growth in Lexapro and Namenda sales, as well as co-promotion income earned on Benicar. We had not earned any co-promotion income in the June 2004 quarter.
During the quarter, we received the results of a recently completed placebo-controlled proof of concept study of neramexane in the treatment of moderate to severe Alzheimer`s disease. The study showed sufficient clinical activity, safety and tolerability for us to continue development of the compound. In July 2005, we received a non-approvable letter from the Food and Drug Administration (FDA) in response to our supplemental New Drug Application (sNDA) to expand the indication of Namenda to include mild Alzheimer`s disease. The FDA accepted the sNDA for review in November 2004. Upon completing its review, the FDA acknowledged that it had informed us that a single positive study in patients with mild to moderate Alzheimer`s disease would be adequate to support extending Namenda`s claim to include mild patients. The FDA further acknowledged that the six-month, U.S. mild to moderate study which reached statistical significance at the required primary endpoints was such a study. Nevertheless, the FDA decided not to approve Namenda for mild patients based upon this single positive study in light of two previously disclosed, additional studies of Namenda in patients with mild to moderate Alzheimer`s disease - a study of Namenda monotherapy conducted by H. Lundbeck A/S in Europe and a combination study conducted by Forest in the U.S. with Namenda administered to patients already taking an acetylcholinesterase inhibitor. In both of these studies, which were included in the sNDA filing, Namenda performed numerically better than placebo; however, statistical significance was not reached at the primary endpoints. In all three studies, Namenda was found to be well tolerated. We plan to meet with the FDA shortly to further discuss the non-approvable letter.
During fiscal 2005, our Board of Directors authorized a share repurchase program for up to 30 million shares of common stock (the 2005 Repurchase Program), of which approximately 6,100,000 shares remained to be purchased during the current fiscal year. As of May 11, 2005, all of these shares were repurchased, completing the program. In May 2005, our Board of Directors authorized a new share repurchase program for up to 25 million shares of common stock (the 2006 Repurchase Program). As of June 30, 2005, 2,400,000 shares have been repurchased under this program and we continue to have authority to purchase up to an additional 22,600,000 shares.
During the fourth quarter of fiscal 2005, we repatriated $1,238,900 in qualifying dividends pursuant to the American Jobs Creation Act of 2004. We intend to utilize the repatriated funds pursuant to a qualified domestic investment plan which we have adopted. This repatriation was the maximum dividend amount allowed and resulted in a one-time tax charge of $90,657. In the current quarter, we reversed $36,414 of this charge based on recently issued U.S. Treasury Department guidance. The originally enacted law did not specifically address whether the deduction applied to the required tax gross-up related to the dividend. In May 2005, the U.S. Treasury Department clarified that the dividend received deduction does in fact apply to the tax gross-up amount and accordingly we were allowed to reverse the $36,414 million in the current quarter. The impact of such reversal, was to increase our diluted earnings per share in the June quarter by $0.10 per share.
Financial Condition and Liquidity
Net current assets increased by $91,691 during the current period from March 31, 2005. During the current quarter, approximately 6.1 million shares of common stock were repurchased pursuant to the 2005 Repurchase Program authorized by our Board of Directors in fiscal 2005, at various prices totaling $217,146, completing that program. In May 2005, our Board of Directors approved the 2006 Repurchase Program, which authorized the repurchase of up to 25 million additional shares. In order to fund these share repurchase programs, as longer term investments matured they are being used either to fund the purchase of common stock or shifted to shorter term investments, in anticipation of further common stock repurchases. During the current quarter, the share repurchase programs were funded with cash generated from normal operating activities and supplemented by maturing investments. As of June 30, 2005 we had repurchased 2.4 million shares pursuant to the 2006 Repurchase Program at various prices totaling $93,816 and we continue to have authorization to purchase an additional 22.6 million shares under this program. In total, cash and marketable securities
- both short-term and long-term - decreased by $139,409 during the current period. Trade accounts receivable increased due to strong sales of our principal branded products, partially offset by lower sales of Celexa due to generic competition, while other accounts receivable decreased due to a payment from Sankyo Pharma for our co-promotion of Benicar. The increase in raw materials was primarily due to increased levels of Lexapro inventory to meet higher demand. Work in process and finished goods inventories decreased during the period primarily due to Lexapro and Namenda, as wholesalers brought their inventories to more normal levels - approximately two and a half to three weeks as compared with the two weeks they were holding at March 31, 2005. We believe that our inventory levels are adequate to support future demand. Other current assets increased due principally to the renewal of our insurance policies, particularly product liability insurance, which are paid in full at the time of renewal and expensed over the course of the year. The changes in accounts payable, particularly the timing of raw material receipts and payments, and accrued expenses were due to normal ongoing operating activities.
Property, plant and equipment increased primarily due to the continuing expansion of our facilities in order to meet future product demands. In Jersey City, we are leasing an additional floor of office space totaling 36,000 square feet to accommodate growth in our Research Institute. On Long Island, we are adding 37,000 square feet to our sales training facility. In fiscal 2005 we purchased a 40,000 square foot facility in St. Louis, which is being used as a data center and we have begun construction on a 141,000 square foot addition to our current distribution facility, which will bring the total capacity of our warehouse and distribution center to approximately 475,000 square feet. In Ireland, we are refurbishing a 90,000 square foot plant which will provide redundancy for the manufacture of Lexapro and Namenda and additional capacity for future products. Further property expansions and acquisitions are planned in the future to meet the needs from increased sales and related production, warehousing and distribution, sales training and for products under development. During the current quarter, we also continued to make technology investments to expand our principal operating systems to include salesforce and warehouse management applications.
During fiscal 2005 our Board of Directors approved the 2005 Repurchase Program which authorized the purchase of up to 30 million shares of common stock. We purchased 23,930,400 shares on the open market at an average price of $42.06 per share during fiscal 2005, and completed the balance of the program in May 2005. The remainder of the shares were purchased at an average price of $35.79, bringing the total cost of the 30 million shares to $1,224,192. On May 10, 2005 our Board of Directors authorized the 2006 Repurchase Program for up to 25 million shares. As of June 30, 2005, 2,400,000 shares have been repurchased under this program and we continue to have authority to purchase up to an additional 22,600,000 shares. We expect to make additional purchases, from time to time in the open market, depending on market conditions.
Management believes that current cash levels, coupled with funds to be generated by ongoing operations, will continue to provide adequate liquidity to facilitate potential acquisitions of products, payment of achieved milestones, capital investments and the 2006 Repurchase Program.
Results of Operations
Net sales decreased $107,743 to $674,653, a 14% decrease from the same period last year, primarily due to generic competition for Celexa. Sales of Celexa were $261,053 in the June 2004 quarter compared with $4,155 in the current period for both the brand and generic combined. Offsetting the losses from Celexa were strong sales of Lexapro and Namenda. Lexapro, our largest product, with sales of $461,072, contributed $97,200 to the net sales change, of which $78,108 was due to volume and $19,092 was due to price. As of June 30, 2005 Lexapro achieved a 20.0% share of total prescriptions in the selective serotonin reuptake inhibitor (SSRI) market. Lexapro has patent protection until 2009 and we have applied for an extension to 2012. In fiscal 2004, we received notification from generic manufacturers that they had filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV Certification with the FDA for a generic equivalent to Lexapro. We believe that our patents on Lexapro are valid. Forest has commenced an action for patent infringement against the third party ANDA filers with a trial date in December 2005.
Sales of Namenda, an N-methyl-D-aspartate (NMDA) receptor antagonist for the treatment of moderate to severe Alzheimer`s disease, launched in March 2004, increased $57,336 as compared to the same period last year to $114,704 for the current quarter. Namenda is the first product indicated for the treatment of moderate to severe Alzheimer`s disease and has generated significant new prescriptions in the retail and long-term care markets. Namenda achieved a 27.3% share of total prescriptions in the Alzheimer`s market as of June 30, 2005. In July 2005, we received a non-approvable letter from the FDA in response to our sNDA to expand the indication of Namenda to include mild Alzheimer`s disease - a study of Namenda monotherapy conducted by H. Lundbeck A/S in Europe and a combination study conducted by Forest in the U.S. with Namenda administered to patients already taking an acetylcholinesterase inhibitor. In both of these studies, which were included in the sNDA filing, Namenda performed numerically better than placebo; however, statistical significance was not reached at the primary endpoints. In all three studies, Namenda was found to be well tolerated. We plan to meet with the FDA shortly to further discuss the non-approvable letter. We anticipate Namenda continuing positive growth through fiscal 2006.
Sales of Campral, which was launched in the fourth quarter of fiscal 2005, amounted to $4,324. Campral is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Sales of Combunox, also launched in the fourth quarter of fiscal 2005, amounted to $58. Combunox, which is for the treatment of acute, moderate to severe pain, had a slower than anticipated uptake at launch due its status as a schedule II controlled substance which initially hinders retail stocking at the pharmacy level. Tiazac sales declined $9,885 from last year due primarily to generic competition. The remainder of the net sales change for the period was due principally to volume fluctuations of our older non-promoted product lines.
Contract revenue for the current quarter was $26,269 compared to $2,252 in the same period last year primarily due to co-promotion income from our co-marketing agreement with Sankyo Pharma for Benicar of $24,267. Under the terms of the agreement, Forest has been co-promoting Benicar since May 2003 and is entitled to a share of the product profits (as defined) from the point the product becomes cumulatively profitable. Benicar became cumulatively profitable during the second quarter of fiscal 2005.
Other income for the current quarter increased over the same period last year primarily due to higher interest income received on funds available for investment resulting from more favorable rates of return.
Cost of sales as a percentage of net sales increased to 23.54% for the current quarter as compared to 22.65% for the same period last year, primarily due to product mix, particularly the mix between branded and generic Tiazac.
Selling, general and administrative expenses increased $29,168 in the current quarter as compared to the same period last year due in large measure to the activities of our salesforce and additional product license amortization expense on our recently launched products.
Research and development expense decreased $28,890 in the current quarter primarily due to the payment to PAION GmbH in the same period last year for the U.S. and Canadian rights to desmoteplase, a compound being investigated for the treatment of acute ischemic stroke. Research and development expense also reflects the following developments:
� During the quarter, we received the results of a recently completed placebo-controlled proof of concept study of neramexane in the treatment of moderate to severe Alzheimer`s disease. The study showed sufficient clinical activity, safety and tolerability for us to continue development of the compound.
� In July 2005, we received a non-approvable letter from the FDA in response to our sNDA to expand the indication of Namenda to include mild Alzheimer`s disease. The FDA accepted the sNDA for review in November 2004. Upon completing its review, the FDA acknowledged that it had informed us that a single positive study in patients with mild to moderate Alzheimer`s disease would be adequate to support extending Namenda`s claim to include mild patients. The FDA further acknowledged that the six-month, U.S. mild to moderate study which reached statistical significance at the required primary endpoints was such a study. Nevertheless, the FDA decided not to approve Namenda for mild patients based upon this single positive study in light of two previously disclosed, additional studies of Namenda in patients with mild to moderate Alzheimer`s disease - a study of Namenda monotherapy conducted by H. Lundbeck A/S in Europe and a combination study conducted by Forest in the U.S. with Namenda administered to patients already taking an acetylcholinesterase inhibitor. In both of these studies, which were included in the sNDA filing, Namenda performed numerically better than placebo; however, statistical significance was not reached at the primary endpoints. In all three studies, Namenda was found to be well tolerated. We plan to meet with the FDA shortly to further discuss the non-approvable letter.
� In November 2004, Forest reported on the development progress of lercanidipine, a calcium channel blocker (CCB), being investigated for the treatment of hypertension. In August 2002, an approvable letter was received from the FDA seeking additional data related to the proposed dosing regimen. In response to the request, we conducted an eight week Phase II pilot study in order to assess the clinical efficacy profile of lercanidipine in a new modified release formulation. The preliminary study results indicated that this modified release version of lercanidipine was associated with a clinically relevant reduction in blood pressure, but did not meet all the pre-set criteria for dose response across the range of doses studied. Lercanidipine treatment was well tolerated in this study. We are evaluating additional alternative extended release formulations and considering future development activities.
� During the third quarter of fiscal 2005, Forest entered into a collaboration agreement with Gedeon Richter Limited for the North American rights to RGH-188, a compound which is being developed for the treatment of schizophrenia, bipolar mania and other psychiatric conditions.
� During the second quarter of fiscal 2005, Forest entered into a collaboration agreement with Glenmark Pharmaceuticals S.A. for the North American development and marketing of GRC 3886, a PDE4 inhibitor which will be developed for the treatment of asthma and COPD. In March 2005, as a result of a successfully completed Phase I single and multiple dose study in the U.K., a milestone payment was made to Glenmark pursuant to the terms of the collaboration agreement.
� During the first quarter of fiscal 2005, we entered into an agreement with PAION GmbH for the development and marketing of desmoteplase, a novel drug currently in Phase III clinical studies for the treatment of acute ischemic stroke.
� During the fourth quarter of fiscal 2004, Forest entered into two licensing agreements; the first with Cypress Bioscience, Inc. for the development and marketing of milnacipran, which is currently in Phase III development as a treatment for fibromyalgia syndrome. We expect to have the results of the first Phase III study of milnacipran in fibromyalgia patients in late September 2005. The second was a development agreement with ChemoCentryx, Inc. for novel therapeutics for autoimmune and inflammatory diseases.
The effective tax rate decreased to 5% in the current quarter as compared to 21% in the same period last year primarily due to a one-time reversal of $36,414 related to the March 2005 charge of $90,657 for the repatriation of dividends pursuant to the American Jobs Creation Act of 2004. Excluding this impact, the effective tax rate would have been 21% and is lower than the U.S. statutory tax rate due to the proportion of earnings generated in lower-taxed foreign jurisdictions versus the United States. These earnings include manufacturing and development income from our operations in Ireland, which are taxed at 10% through 2010 and at 12.5% thereafter.
On October 22, 2004, the American Jobs Creation Act of 2004 (the Act) was signed into law. The Act contains numerous changes to existing tax laws, including both domestic and foreign tax incentives. One of the key provisions of the Act, new Internal Revenue Code Section 965, includes a temporary incentive for U.S. multinationals to repatriate foreign earnings by providing an elective 85% dividends received deduction for certain cash dividends from controlled foreign corporations. The provision is effective for dividends paid during the taxable year beginning before the date of enactment or the first taxable year beginning on or after the date of enactment. Moreover, the dividends must be invested in the United States under a domestic reinvestment plan approved by senior management and, subsequently, the board of directors. The provision contains a non-exclusive list of examples of permitted uses of the funds which include funding of worker hiring and training, infrastructure, research and development, capital investment and the financial stabilization of the corporation for purposes of job retention and creation. The dividends subject to the dividend received deduction must not exceed the greater of $500,000 or the earnings reported on the company`s financial statements pursuant to Accounting Principles Board Opinion No. 23 as permanently invested earnings for financial statements certified on or before June 30, 2003. Forest, upon satisfying the U.S. investment criteria and other requirements under the Act, as well as evaluating the guidance provided by the U.S. Treasury Department, executed such a qualifying repatriation in the amount of $1,238,900, the maximum dividend amount for which the special deduction under the Act may be claimed. The resulting additional U.S. tax of $90,657 with respect to such repatriation was provided for in our fiscal 2005 income tax expense. In the current quarter, we reversed $36,414 of this accrual based on recently issued U.S. Treasury Department guidance. Since the originally enacted law did not specifically address whether the deduction applied to the required tax gross-up related to the dividend as of the date the financial statements were prepared for the March 2005 quarter, Forest accrued the tax assuming the deduction did not apply which represented an additional $36 million of tax. In May the U.S. Treasury Department clarified that the dividend received deduction does in fact apply to the tax gross-up amount and accordingly we were allowed to reverse the $36 million in the current quarter.
We expect to continue our profitability in the current fiscal year with continued growth in our principal promoted products.
Inflation has not had a material effect on our operations for the periods presented.
Critical Accounting Policies
The following accounting policies are important in understanding our financial condition and results of operations and should be considered an integral part of the financial review. Refer to the notes to the consolidated financial statements for additional policies.
Estimates and Assumptions
The preparation of financial statements in conformity with generally accepted accounting principles requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and of revenues and expenses during the reporting period. Estimates are made when accounting for sales allowances, returns, rebates and other pricing adjustments, depreciation, amortization and certain contingencies. Forest is subject to risks and uncertainties, which may include but are not limited to competition, federal or local legislation and regulations, litigation and overall changes in the healthcare environment that may cause actual results to vary from estimates. We review all significant estimates affecting the financial statements on a recurring basis and record the effect of any adjustments when necessary. Certain of these risks, uncertainties and assumptions are discussed further under the section entitled "Forward Looking Statements".
Revenue Recognition
Revenues are recorded in the period the merchandise is shipped. As is typical in the pharmaceutical industry, gross product sales are subject to a variety of deductions, primarily representing rebates and discounts to government agencies, wholesalers and managed care organizations. These deductions represent estimates of the related liabilities and, as such, judgment is required when estimating the impact of these sales deductions on gross sales for a reporting period. If estimates are not representative of actual settlement, results could be materially affected. Provisions for estimated sales allowances, returns, rebates and other pricing adjustments are accrued at the time revenues are recognized as a direct reduction of such revenue.
The accruals are estimated based on available information, including third party data, regarding the portion of sales on which rebates and discounts can be earned, adjusted as appropriate for specific known events and the prevailing contractual discount rate. Provisions are reflected either as a direct reduction to accounts receivable or, to the extent that they are due to entities other than customers, as accrued expense. Adjustments to estimates are recorded when customer credits are issued or payments are made to third parties.
The sensitivity of estimates can vary by program and type of customer. However, estimates associated with Medicaid and contract rebates are most at risk for adjustment because of the extensive time delay between the recording of the accrual and its ultimate settlement, an interval that can range up to one year. Because of this time lag, in any given quarter, adjustments to actual may incorporate revisions of prior quarters.
Provisions for Medicaid and contract rebates during a period are recorded based upon the actual historical experience ratio of rebates paid and actual prescriptions written. The experience ratio is applied to the period`s sales to determine the rebate accrual and related expense. This experience ratio is evaluated regularly to ensure that the historical trends are as current as practicable. As appropriate, we will adjust the ratio to more closely match the current experience or expected future experience. In assessing this ratio, we consider current contract terms, such as the effect of changes in formulary status, discount rate and utilization trends. Periodically, the accrual is adjusted based upon actual payments made for rebates. If the ratio is not indicative of future experience, results could be affected. Rebate accruals for Medicaid were $52,729 at June 30, 2005 and $58,026 at June 30, 2004. Commercial discounts and other rebate accruals were $53,902 at June 30, 2005 and $103,733 at June 30, 2004. These and other rebate accruals are established in the period the related revenue was recognized, resulting in a reduction to sales and the establishment of a liability, which is included in accrued expenses.
The following table summarizes the quarterly activity in the accounts related to accrued rebates, sales returns and discounts (In thousands):
June 30, 2005 June 30, 2004
$171,119 $266,209
Beginning balance
56,818 50,380
Provision for rebates ( 61,233) ( 74,233)
Settlements ( 4,415) ( 23,853)
6,540 8,599
Provision for returns ( 7,601) ( 6,950)
Settlements ( 1,061) 1,649
106,890 95,465
Provision for chargebacks and discounts ( 101,571) ( 95,503)
Settlements 5,319 ( 38)
$170,962 $243,967
Ending balance
Deductions for chargebacks (primarily discounts to group purchasing organizations and federal government agencies) closely approximate actual as these deductions are settled generally within 2-3 weeks of incurring the liability.
Forest`s policy relating to the supply of inventory at wholesalers is to maintain stocking levels of up to three weeks and to keep monthly levels consistent from year to year, based on patterns of utilization. We have historically closely monitored wholesale customer stocking levels by purchasing information directly from customers and by obtaining other third party information. Unusual or unexpected variations in buying patterns or utilizations are investigated.
Sales incentives are generally given in connection with a new product launch. These sales incentives are recorded as a reduction of revenues and are based on terms fixed at the time goods are shipped. New product launches may result in expected temporary increases in wholesaler inventories, which as described above, are closely monitored and have not resulted in increased product returns.
Forward Looking Statements
Except for the historical information contained herein, the Management Discussion and other portions of this Form 10-Q contain forward looking statements that involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in our filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended March 31, 2005.
[posting]17.492.660 von RogerKLAUS am 09.08.05 16:05:12[/posting]Generics should be forbidden.
Oral Solution Formulation of Namenda(R), the Only FDA-Approved Oral Solution for Moderate to Severe Alzheimer`s Disease, Now Available
Thursday August 18, 5:10 pm ET
NEW YORK, Aug. 18 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX - News) announced today that an oral solution formulation of Namenda®(memantine HCl), the only FDA-approved treatment for moderate to severe Alzheimer`s disease, is now available to physicians, patients, and pharmacies nationwide. Oral solution offers an alternative that may make administration of Namenda easier for those patients who have trouble swallowing tablets, and for those who prefer taking medication in liquid form.
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The oral solution of Namenda is equivalent on a milligram per milligram basis to the Namenda tablets and is administered in the same manner. Namenda oral solution is available in a 2mg/ml concentration, 360 ml (12 oz) bottle.
About Namenda
Namenda (memantine HCl) is the first in a class of medications with a unique mechanism of action that focuses on the glutamate pathway, a target for the treatment of Alzheimer`s disease. Indicated for the treatment of moderate to severe Alzheimer`s disease, the FDA approved Namenda (October 2003) based on three studies of Namenda used alone or in combination with another Alzheimer`s disease drug.
Namenda is contraindicated in patients with known hypersensitivity to memantine HCl or any excipients used in the formulation. The most common adverse events reported with Namenda vs placebo (greater-than or equal-to 5% and higher than placebo) were dizziness, confusion, headache, and constipation. In patients with severe renal impairment, the dosage should be reduced.
About Forest Laboratories and Its Products
Forest Laboratories` growing line of products includes: Lexapro® (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda®(memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer`s disease; Benicar®*(olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar HCT®(olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; Campral®*(acamprosate calcium), a glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation in combination with psychosocial support; and Combunox(TM)(Oxycodone HCl and Ibuprofen), an opioid and NSAID combination indicated for the short-term management of acute, moderate to severe pain.
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. These statements are subject to risks and uncertainties that affect our business, including risk factors listed from time to time in the Company`s SEC reports, including the Company`s Annual Report on Form 10-K for the fiscal year ended March 31, 2005 and on form 10-Q for the periods ended June 30, 2005. Actual results may differ materially from those projected.
* Benicar is a registered trademark of Sankyo Pharma Inc.; Campral is a
registered trademark under license from Merck Sante s.a.s., subsidiary
of Merck KGaA, Darmstadt, Germany.
Forest Laboratories markets Namenda®(memantine HCl) in the United States under license from Merz Pharma GmbH & Co. of Germany. Lundbeck, under license from Merz, markets memantine as Ebixa®, and Merz markets memantine as Axura® and as Akatinol®, each in a number of markets worldwide. Ebixa, Axura, and Akatinol are registered trademarks Merz Pharma GmbH & Co.
Source: Forest Laboratories, Inc.
Thursday August 18, 5:10 pm ET
NEW YORK, Aug. 18 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX - News) announced today that an oral solution formulation of Namenda®(memantine HCl), the only FDA-approved treatment for moderate to severe Alzheimer`s disease, is now available to physicians, patients, and pharmacies nationwide. Oral solution offers an alternative that may make administration of Namenda easier for those patients who have trouble swallowing tablets, and for those who prefer taking medication in liquid form.
ADVERTISEMENT
Click Here
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
The oral solution of Namenda is equivalent on a milligram per milligram basis to the Namenda tablets and is administered in the same manner. Namenda oral solution is available in a 2mg/ml concentration, 360 ml (12 oz) bottle.
About Namenda
Namenda (memantine HCl) is the first in a class of medications with a unique mechanism of action that focuses on the glutamate pathway, a target for the treatment of Alzheimer`s disease. Indicated for the treatment of moderate to severe Alzheimer`s disease, the FDA approved Namenda (October 2003) based on three studies of Namenda used alone or in combination with another Alzheimer`s disease drug.
Namenda is contraindicated in patients with known hypersensitivity to memantine HCl or any excipients used in the formulation. The most common adverse events reported with Namenda vs placebo (greater-than or equal-to 5% and higher than placebo) were dizziness, confusion, headache, and constipation. In patients with severe renal impairment, the dosage should be reduced.
About Forest Laboratories and Its Products
Forest Laboratories` growing line of products includes: Lexapro® (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda®(memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer`s disease; Benicar®*(olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar HCT®(olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; Campral®*(acamprosate calcium), a glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation in combination with psychosocial support; and Combunox(TM)(Oxycodone HCl and Ibuprofen), an opioid and NSAID combination indicated for the short-term management of acute, moderate to severe pain.
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. These statements are subject to risks and uncertainties that affect our business, including risk factors listed from time to time in the Company`s SEC reports, including the Company`s Annual Report on Form 10-K for the fiscal year ended March 31, 2005 and on form 10-Q for the periods ended June 30, 2005. Actual results may differ materially from those projected.
* Benicar is a registered trademark of Sankyo Pharma Inc.; Campral is a
registered trademark under license from Merck Sante s.a.s., subsidiary
of Merck KGaA, Darmstadt, Germany.
Forest Laboratories markets Namenda®(memantine HCl) in the United States under license from Merz Pharma GmbH & Co. of Germany. Lundbeck, under license from Merz, markets memantine as Ebixa®, and Merz markets memantine as Axura® and as Akatinol®, each in a number of markets worldwide. Ebixa, Axura, and Akatinol are registered trademarks Merz Pharma GmbH & Co.
Source: Forest Laboratories, Inc.
UPDATE 2-Forest Labs` fibromyalgia study doesn`t meet goal
Wed Sep 28, 2005 06:38 PM ET
(Adds analyst comment, byline)
By Deena Beasley
LOS ANGELES, Sept 28 (Reuters) - Forest Laboratories Inc. (FRX.N: Quote, Profile, Research) and Cypress Bioscience Inc. (CYPB.O: Quote, Profile, Research) said on Wednesday that early results from a pivotal study of milnacipran as a treatment for fibromyalgia show that the trial did not meet its primary goal.
Shares of Cypress Bioscience fell 51 percent to $6.21 in after-hours trading from a Nasdaq close of $12.70. Shares of Forest Labs were nearly 8 percent lower at $39.24 after closing at $42.30 on the New York Stock Exchange.
"For Forest, this was, and I guess still is, the next important growth driver in the pipeline ... It is kind of the whole deal for Cypress," said David Windley, an analyst at Jefferies & Co. He owns shares of Forest, but Jefferies does not have a banking relationship with the drugmaker.
The companies said the Phase III study of 888 patients failed to prove a statistically significant link between the drug and reduction in pain as well as improvement in patient well-being.
But a response to the treatment was demonstrated and the companies said they would conduct further analysis, and that the results supported continued development of the drug.
Fibromyalgia syndrome is a chronic disorder that causes widespread pain in the muscles and soft tissues. The disease is estimated to affect about six million Americans, most of them women.
Milnacipran is the first of a new class of agents known as norepinephrine serotonin reuptake inhibitors.
The drug`s developers said an ongoing Phase III trial of milnacipran will continue and another Phase III trial will soon by launched by Forest Labs.
Analysts had been expecting the companies to file for U.S. regulatory approval of the drug in late 2006 or early 2007, but a third trial is likely to delay the filing, Windley said.
The second Phase III trial has a similar design to the first one, he said. Officials at Forest Labs were not available to comment on the design of the third trial.
Forest Labs is still recovering from the onset of generic competition for its former best-selling depression drug Celexa. "There was a gap in the pipeline between that and the next sizable product. This (the delay with milnacipran) widens that gap," Windley said.
Wed Sep 28, 2005 06:38 PM ET
(Adds analyst comment, byline)
By Deena Beasley
LOS ANGELES, Sept 28 (Reuters) - Forest Laboratories Inc. (FRX.N: Quote, Profile, Research) and Cypress Bioscience Inc. (CYPB.O: Quote, Profile, Research) said on Wednesday that early results from a pivotal study of milnacipran as a treatment for fibromyalgia show that the trial did not meet its primary goal.
Shares of Cypress Bioscience fell 51 percent to $6.21 in after-hours trading from a Nasdaq close of $12.70. Shares of Forest Labs were nearly 8 percent lower at $39.24 after closing at $42.30 on the New York Stock Exchange.
"For Forest, this was, and I guess still is, the next important growth driver in the pipeline ... It is kind of the whole deal for Cypress," said David Windley, an analyst at Jefferies & Co. He owns shares of Forest, but Jefferies does not have a banking relationship with the drugmaker.
The companies said the Phase III study of 888 patients failed to prove a statistically significant link between the drug and reduction in pain as well as improvement in patient well-being.
But a response to the treatment was demonstrated and the companies said they would conduct further analysis, and that the results supported continued development of the drug.
Fibromyalgia syndrome is a chronic disorder that causes widespread pain in the muscles and soft tissues. The disease is estimated to affect about six million Americans, most of them women.
Milnacipran is the first of a new class of agents known as norepinephrine serotonin reuptake inhibitors.
The drug`s developers said an ongoing Phase III trial of milnacipran will continue and another Phase III trial will soon by launched by Forest Labs.
Analysts had been expecting the companies to file for U.S. regulatory approval of the drug in late 2006 or early 2007, but a third trial is likely to delay the filing, Windley said.
The second Phase III trial has a similar design to the first one, he said. Officials at Forest Labs were not available to comment on the design of the third trial.
Forest Labs is still recovering from the onset of generic competition for its former best-selling depression drug Celexa. "There was a gap in the pipeline between that and the next sizable product. This (the delay with milnacipran) widens that gap," Windley said.
[posting]18.075.251 von RogerKLAUS am 29.09.05 10:59:41[/posting]Hohe Gewinnaussichten, hohes Risiko. So war es schon immer.
Hoffen wir das Beste.
Hoffen wir das Beste.
Cypres hat es heute richtig schlimm erwischt.
Über 55% minus.
Über 55% minus.
Hier mal eine Meldung, die das gegenwärtige Patentwirrwar um Laxapro ganz gut durchleuchtet.
Gruß
Balou
-----
UPDATE 2-Lundbeck settles patent case with Alphapharm
Thu Oct 6, 2005 11:33 AM ET
(Rewrites with CEO, analyst quotes)
By Per Bech Thomsen
COPENHAGEN, Oct 6 (Reuters) - Danish pharmaceutical group Lundbeck (LUN.CO: Quote, Profile, Research) said on Thursday it had settled a patent infringement case regarding its antidepressant Lexapro with Australian generic drugmaker Alphapharm.
The deal was seen as a defensive measure by Lundbeck and Forest Laboratories (FRX.N: Quote, Profile, Research) , which has the rights to sell Lexapro in the United States, to protect revenues if they lose a similar patent case against U.S.-based IVAX Corp. (IVX.A: Quote, Profile, Research) .
"The Alphapharm deal is a backstop or defensive move in response to the ongoing litigation between Ivax and Forest/Lundbeck. Should IVAX win the patent dispute over Lexapro, they will be entitled to 180 days exclusivity to the generic market for Lexapro," Morgan Stanley said in a research note.
As part of the settlement, Lundbeck and Forest agreed to give Alphapharm, a unit of German drugmaker Merck KGaA (MRCG.DE: Quote, Profile, Research) , the right to distribute an authorised generic version of Lexapro in the U.S. when the patent expires, or sooner if Lundbeck and Forest lose the case against IVAX.
The move follows a trend among drug companies to launch their own approved, or authorised, generics when medicines lose patent protection.
The patent on Lexapro expires in June 2009, but Lundbeck expects it to be extended to March 2012.
"The deal simply ensures that Forest/Lundbeck will participate in the profitable 180 day exclusivity period. The deal will only be activated should Ivax be successful in overturning the court case," Morgan Stanley said.
Under either scenario, Alphapharm will pay Forest a portion of the profit from the generic sales of Lexapro, said Lundbeck, which gets royalties from Forest`s sale of the antidepressant.
On Wednesday IVAX denied market speculation that it was in settlement talks with Forest and Lundbeck regarding the patent dispute, but Lundbeck is ready to settle the dispute with IVAX.
"If IVAX approaches us, we will definitely consider a similar settlement," Lundbeck Chief Executive Claus Braestrup told Reuters.
By 1518 GMT, Lundbeck shares were down 2.8 percent at 153.50 crowns, extending losses from just before the announcement, and underperforming the Copenhagen bourse`s top-20 OMXC-index , which was down 1.1 percent.
"The agreement is positive, because there is now one fewer case to worry about," said Sydbank analyst Brian Kirk.
"Distribution rights to Alphapharm was the price Lundbeck and Forest had to pay to reach the agreement. If a generic version were sold on the market, Lundbeck wouldn`t make much money anyway."
Gruß
Balou
-----
UPDATE 2-Lundbeck settles patent case with Alphapharm
Thu Oct 6, 2005 11:33 AM ET
(Rewrites with CEO, analyst quotes)
By Per Bech Thomsen
COPENHAGEN, Oct 6 (Reuters) - Danish pharmaceutical group Lundbeck (LUN.CO: Quote, Profile, Research) said on Thursday it had settled a patent infringement case regarding its antidepressant Lexapro with Australian generic drugmaker Alphapharm.
The deal was seen as a defensive measure by Lundbeck and Forest Laboratories (FRX.N: Quote, Profile, Research) , which has the rights to sell Lexapro in the United States, to protect revenues if they lose a similar patent case against U.S.-based IVAX Corp. (IVX.A: Quote, Profile, Research) .
"The Alphapharm deal is a backstop or defensive move in response to the ongoing litigation between Ivax and Forest/Lundbeck. Should IVAX win the patent dispute over Lexapro, they will be entitled to 180 days exclusivity to the generic market for Lexapro," Morgan Stanley said in a research note.
As part of the settlement, Lundbeck and Forest agreed to give Alphapharm, a unit of German drugmaker Merck KGaA (MRCG.DE: Quote, Profile, Research) , the right to distribute an authorised generic version of Lexapro in the U.S. when the patent expires, or sooner if Lundbeck and Forest lose the case against IVAX.
The move follows a trend among drug companies to launch their own approved, or authorised, generics when medicines lose patent protection.
The patent on Lexapro expires in June 2009, but Lundbeck expects it to be extended to March 2012.
"The deal simply ensures that Forest/Lundbeck will participate in the profitable 180 day exclusivity period. The deal will only be activated should Ivax be successful in overturning the court case," Morgan Stanley said.
Under either scenario, Alphapharm will pay Forest a portion of the profit from the generic sales of Lexapro, said Lundbeck, which gets royalties from Forest`s sale of the antidepressant.
On Wednesday IVAX denied market speculation that it was in settlement talks with Forest and Lundbeck regarding the patent dispute, but Lundbeck is ready to settle the dispute with IVAX.
"If IVAX approaches us, we will definitely consider a similar settlement," Lundbeck Chief Executive Claus Braestrup told Reuters.
By 1518 GMT, Lundbeck shares were down 2.8 percent at 153.50 crowns, extending losses from just before the announcement, and underperforming the Copenhagen bourse`s top-20 OMXC-index , which was down 1.1 percent.
"The agreement is positive, because there is now one fewer case to worry about," said Sydbank analyst Brian Kirk.
"Distribution rights to Alphapharm was the price Lundbeck and Forest had to pay to reach the agreement. If a generic version were sold on the market, Lundbeck wouldn`t make much money anyway."
Heute wurden die Q3 Ergebnisse päsentiert. Wie nicht anders zu erwarten, konnten die Ergebnisse des Vorjahresquartals bei weitem nicht erreicht werden. Das hat allerdings auch keiner erwartet und die "earnings per share" lagen sogar leicht über den Erwartungen.
Jetzt haben wir nur noch ein "schwieriges" Quartal mit fallendem Umsatz und Gewinn vor der Brust, dann ist der Auslauf des "Celexa" Patentes verdaut.
Allerdings gibt die Pipeline momentan auch nichts her, womit kurzfristig weiteres Wachstum generiert werden könnte. Mal sehen, ob der conference call noch was an Informationen bringt.
Gruß
Balou
-----
Forest Labs 2Q Profit Down 16 Percent
Tuesday October 18, 8:51 am ET
Drug Maker Forest Laboratories Second-Quarter Profit Falls 16 Percent, but Beats Estimates
NEW YORK (AP) -- Drug maker Forest Laboratories Inc. said Tuesday that second-quarter profit fell 16 percent as sales of one of its antidepressants plummeted because of competition from generics.
Net income declined to $204.9 million, or 59 cents per share, from $295.3 million, or 79 cents per share, a year ago. Revenue fell 19 percent to $736.5 million from $881.2 million last year.
Despite the decline, the per-share result managed to beat Wall Street earnings estimates. Analysts surveyed by Thomson Financial estimated earnings per share of 56 cents but expected higher revenue of $749.2 million.
Second-quarter sales of antidepressant Celexa fell to $4.4 million from $256.4 million a year ago as drug makers entered the market with a generic equivalent in February. Sales of the company`s other antidepressant, Lexapro, rose to $467.4 million from $414.9 million a year ago.
Additionally, sales of Alzheimer`s disease treatment Namenda grew 53 percent to $123.9 million from last year.
The company still expects to meet an earnings per share forecast of $2.30, or $2.40 excluding one-time items, on revenue of about $3 billion for 2005. Analysts expect earnings per share of $2.32 on revenue of $3.07 billion.
-----
Jetzt haben wir nur noch ein "schwieriges" Quartal mit fallendem Umsatz und Gewinn vor der Brust, dann ist der Auslauf des "Celexa" Patentes verdaut.
Allerdings gibt die Pipeline momentan auch nichts her, womit kurzfristig weiteres Wachstum generiert werden könnte. Mal sehen, ob der conference call noch was an Informationen bringt.
Gruß
Balou
-----
Forest Labs 2Q Profit Down 16 Percent
Tuesday October 18, 8:51 am ET
Drug Maker Forest Laboratories Second-Quarter Profit Falls 16 Percent, but Beats Estimates
NEW YORK (AP) -- Drug maker Forest Laboratories Inc. said Tuesday that second-quarter profit fell 16 percent as sales of one of its antidepressants plummeted because of competition from generics.
Net income declined to $204.9 million, or 59 cents per share, from $295.3 million, or 79 cents per share, a year ago. Revenue fell 19 percent to $736.5 million from $881.2 million last year.
Despite the decline, the per-share result managed to beat Wall Street earnings estimates. Analysts surveyed by Thomson Financial estimated earnings per share of 56 cents but expected higher revenue of $749.2 million.
Second-quarter sales of antidepressant Celexa fell to $4.4 million from $256.4 million a year ago as drug makers entered the market with a generic equivalent in February. Sales of the company`s other antidepressant, Lexapro, rose to $467.4 million from $414.9 million a year ago.
Additionally, sales of Alzheimer`s disease treatment Namenda grew 53 percent to $123.9 million from last year.
The company still expects to meet an earnings per share forecast of $2.30, or $2.40 excluding one-time items, on revenue of about $3 billion for 2005. Analysts expect earnings per share of $2.32 on revenue of $3.07 billion.
-----
Da ich ja gerne bei den Motly Fools stöbere, hier mal auszugsweise ein Artikel von S.D. Simpson. Gibt meine Erwartung / Hoffnung / Stimmung ganz gut wieder.
-----
Forest Labs` Clear-Cut Woes
By Stephen D. Simpson, CFA
October 18, 2005
...Whatever the outcome of the patent dispute, Forest absolutely needs to bring some product candidates into the pipeline. Fortunately, the company has a decent reputation for commercializing drugs and plenty of cash available for upfront licensing payments. Management said that it expects to add several new candidates in the coming months. Let`s hope it does; bringing potential new revenue on board should be a high priority for this company.
Forest Labs will test shareholders` patience, and I could readily understand why some would rather wait for new product announcements before buying. That said, the Street seldom rewards the obvious; any gains from this stock will probably go to those brave enough to invest ahead of the news....
----
Gruß
Balou
-----
Forest Labs` Clear-Cut Woes
By Stephen D. Simpson, CFA
October 18, 2005
...Whatever the outcome of the patent dispute, Forest absolutely needs to bring some product candidates into the pipeline. Fortunately, the company has a decent reputation for commercializing drugs and plenty of cash available for upfront licensing payments. Management said that it expects to add several new candidates in the coming months. Let`s hope it does; bringing potential new revenue on board should be a high priority for this company.
Forest Labs will test shareholders` patience, and I could readily understand why some would rather wait for new product announcements before buying. That said, the Street seldom rewards the obvious; any gains from this stock will probably go to those brave enough to invest ahead of the news....
----
Gruß
Balou
[posting]18.383.407 von Balou2 am 22.10.05 23:55:51[/posting]Ich halte ziemlich viel von diesem Simpson. Gute Leute werden selten über Nacht schlecht. Dass es im Geschäftsleben Auf und Abs gibt, weiß ich aus eigener Erfahrung.
Auch hier denke ich, wird Geduld belohnt werden.
Auch hier denke ich, wird Geduld belohnt werden.
Hallo,
hab gerade ne Nachricht von Forest Labs in meinem E-Mail-Account gefunden.
Der Verhandlungstermin zum Lexapro-Fall wird vom 5. Dezember auf den 15. März 2006 verschoben.
Gruß grigri
hab gerade ne Nachricht von Forest Labs in meinem E-Mail-Account gefunden.
Der Verhandlungstermin zum Lexapro-Fall wird vom 5. Dezember auf den 15. März 2006 verschoben.
Gruß grigri
[posting]18.468.440 von grigri4 am 27.10.05 14:15:17[/posting]Und man gibt sich zuversichtlich bei Forest.
Gedeon Richter and Forest Laboratories Expand Relationship with Two New Collaborations for CNS Compounds
NEW YORK and BUDAPEST, Hungary, Nov. 28 /PRNewswire-FirstCall/ -- Gedeon Richter Limited (Reuters: GDRB.BU; Bloomberg: RICHT HB) and its wholly owned subsidiary Gedeon Richter USA, Inc. and Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX) have entered into two new collaboration agreements involving two novel mechanisms targeted for the treatment of various CNS conditions. These two new agreements build upon the existing collaboration announced last year for a novel antipsychotic.
RGH-896
The first new collaboration will focus upon a group of compounds that target the NMDA 2B receptor and will be developed for the treatment of chronic pain and other CNS conditions. RGH-896 is the first of this group and is currently in early clinical development. Forest and Richter intend to initiate a Phase IIb study in neuropathic pain in the United Stated in the second half of 2006. In addition to neuropathic pain, the companies intend to investigate various other pain conditions and possibly CNS indications not related to pain. RGH-896 represents a novel approach to neuropathic pain by targeting a specific portion of the NMDA receptor that may be involved in the transmission of pain. Forest will pay Richter undisclosed upfront and milestone payments in addition to royalties and will have exclusive rights in the U.S. and Canada. The two companies will jointly fund the development program. RGH-896 has patent applications that provide patent protection until at least 2022.
mGLUR1/5 Compounds
The second new collaboration will focus upon a group of novel compounds that target the group 1 metabotropic glutamate receptors (mGLUR1/5). mGLUR1/5 antagonists represent novel, potential agents for the treatment of anxiety, depression and other CNS conditions. Richter and Forest intend to advance promising leads to clinical trials within the next two to three years. Forest will pay Richter undisclosed upfront and milestone payments in addition to royalties and will have exclusive rights in North America while Richter will retain exclusive rights in Europe and countries of the former Soviet Union. The two companies will share rights in all other territories.
The two new agreements build upon the ongoing and successful collaboration between the two companies announced last year for the novel antipsychotic RGH-188 and related compounds. RGH-188 has successfully completed testing in healthy volunteers and is currently undergoing initial trials in schizophrenia patients.
Erik Bogsch, CEO of Gedeon Richter Ltd., stated: "We are very pleased to announce Richter`s new agreements for two CNS development projects with Forest. This perfectly fits our corporate goal of establishing strategic alliances. Forest is one of the industry`s leaders in the CNS field with excellent scientific and marketing expertise in North America. The teams of Forest and Richter have established an excellent working relationship in the past year on RGH-188, a potential antipsychotic. This served as a catalyst for the two new projects, one at an early research stage, mGluR1/5, and the other, RGH-896, in early Phase II. The human studies will take several years before their submission to the regulatory agencies. The success of the compounds obviously will depend on the results of this extensive testing."
Howard Solomon, Chairman and Chief Executive Officer of Forest, commented: "We are delighted to partner with Gedeon Richter in two additional development projects. Gedeon Richter has outstanding discovery and chemistry skills, as refined and skilled and creative as any company anywhere, and combined with our development, clinical and regulatory experience, we believe that together we can create and that we can market new therapies that will benefit many patients. Both companies are particularly focused on CNS drugs, still the most difficult, the most unexplored, the most mysterious and the most needy from the patients` viewpoint of all therapeutic areas. This transaction will further build on Forest`s expertise in the field of NMDA receptors and the excitatory neurotransmitter glutamate."
About RGH-896 and NR2B:
RGH-896 is an orally active selective NR2B antagonist in Phase II development. NR2B is predominantly expressed on pain processing neuronal pathways. By blocking NR2B, RGH-896 and related compounds block pain signaling without interacting with other NMDA receptor subtypes thus potentially improving therapeutic index and side effect profile. Pre-clinical data with RGH-896 and related compounds support development in neuropathic pain and possibly other chronic pain conditions. The neuropathic pain market in the United States is estimated to exceed $2 Billion dollars annually. Currently available therapies are inadequate with room to improve efficacy, tolerability and dosing regimens. There is also an unmet need in other chronic pain conditions such as chronic osteoarthritis pain and low back pain which afflict a large number of patients and for which there are no wholly adequate therapies. A novel medication that is effective and well tolerated could expand this market and may have significant commercial potential.
About mGLUR1/5
Group 1 metabotropic glutamate receptors (mGluR1 and 5) are G-protein coupled receptors (GPCRs) that are activated by the excitatory neurotransmitter glutamate. These receptors are distinct from other glutamate receptors, e.g. ionotropic NMDA and AMPA receptors. Over the past decade, mGluRs have emerged as an exciting therapeutic target for a variety of psychiatric and neurological disorders including anxiety, depression, pain and other conditions. The potential advantages of targeting mGluR1/5 include improved efficacy and safety/tolerability compared with currently used therapeutics.
About Forest Laboratories Inc. and Its Products
Forest Laboratories` (http://www.frx.com) growing line of products includes: Lexapro(R) (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda(R) (memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer`s disease; Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar* HCT(R) (olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; Campral(R)* (acamprosate calcium), a glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation in combination with psychosocial support; and Combunox(TM) (Oxycodone HCl and Ibuprofen), an opioid and NSAID combination indicated for the short-term management of acute, moderate to severe pain.
* Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is a registered trademark under license from Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in the Company`s SEC reports, including the Company`s Annual Report on Form 10-K for the fiscal year ended March 31, 2005 and on Form 10-Q for the periods ended June 30, 2005 and September 30, 2005.
About Gedeon Richter Limited
Gedeon Richter Ltd., (http://www.richter.hu) headquartered in Budapest/Hungary, is the leading pharmaceutical company in Hungary and one of the largest in Central Eastern Europe, with more than 3 billion US$ market capitalization. The company was founded in 1901. Gedeon Richter Ltd. plays the role of a regional multinational company in Central Eastern Europe and in the CIS, and has a growing presence through its commercial subsidiaries in key EU countries, and the USA. Two thirds of its annual sales of more than 599 million USD in 2004 are exported to 80 countries (EU, USA, Japan, Russia etc.) The company has a worldwide presence through its representative offices, subsidiaries in 30 countries. It has production facilities in Russia and Romania and Poland and there is one under construction in India. The product portfolio of the company includes more than 100 products and covers almost all important therapeutic areas. Based on its traditional skills in steroid chemistry, the company is a significant player in the gynaecological field worldwide. A significant part of the company`s turnover results from original drug research and development activity, which is focused on the diseases of the central nervous system since 1999.
SOURCE Forest Laboratories Holdings, Ltd.
NEW YORK and BUDAPEST, Hungary, Nov. 28 /PRNewswire-FirstCall/ -- Gedeon Richter Limited (Reuters: GDRB.BU; Bloomberg: RICHT HB) and its wholly owned subsidiary Gedeon Richter USA, Inc. and Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX) have entered into two new collaboration agreements involving two novel mechanisms targeted for the treatment of various CNS conditions. These two new agreements build upon the existing collaboration announced last year for a novel antipsychotic.
RGH-896
The first new collaboration will focus upon a group of compounds that target the NMDA 2B receptor and will be developed for the treatment of chronic pain and other CNS conditions. RGH-896 is the first of this group and is currently in early clinical development. Forest and Richter intend to initiate a Phase IIb study in neuropathic pain in the United Stated in the second half of 2006. In addition to neuropathic pain, the companies intend to investigate various other pain conditions and possibly CNS indications not related to pain. RGH-896 represents a novel approach to neuropathic pain by targeting a specific portion of the NMDA receptor that may be involved in the transmission of pain. Forest will pay Richter undisclosed upfront and milestone payments in addition to royalties and will have exclusive rights in the U.S. and Canada. The two companies will jointly fund the development program. RGH-896 has patent applications that provide patent protection until at least 2022.
mGLUR1/5 Compounds
The second new collaboration will focus upon a group of novel compounds that target the group 1 metabotropic glutamate receptors (mGLUR1/5). mGLUR1/5 antagonists represent novel, potential agents for the treatment of anxiety, depression and other CNS conditions. Richter and Forest intend to advance promising leads to clinical trials within the next two to three years. Forest will pay Richter undisclosed upfront and milestone payments in addition to royalties and will have exclusive rights in North America while Richter will retain exclusive rights in Europe and countries of the former Soviet Union. The two companies will share rights in all other territories.
The two new agreements build upon the ongoing and successful collaboration between the two companies announced last year for the novel antipsychotic RGH-188 and related compounds. RGH-188 has successfully completed testing in healthy volunteers and is currently undergoing initial trials in schizophrenia patients.
Erik Bogsch, CEO of Gedeon Richter Ltd., stated: "We are very pleased to announce Richter`s new agreements for two CNS development projects with Forest. This perfectly fits our corporate goal of establishing strategic alliances. Forest is one of the industry`s leaders in the CNS field with excellent scientific and marketing expertise in North America. The teams of Forest and Richter have established an excellent working relationship in the past year on RGH-188, a potential antipsychotic. This served as a catalyst for the two new projects, one at an early research stage, mGluR1/5, and the other, RGH-896, in early Phase II. The human studies will take several years before their submission to the regulatory agencies. The success of the compounds obviously will depend on the results of this extensive testing."
Howard Solomon, Chairman and Chief Executive Officer of Forest, commented: "We are delighted to partner with Gedeon Richter in two additional development projects. Gedeon Richter has outstanding discovery and chemistry skills, as refined and skilled and creative as any company anywhere, and combined with our development, clinical and regulatory experience, we believe that together we can create and that we can market new therapies that will benefit many patients. Both companies are particularly focused on CNS drugs, still the most difficult, the most unexplored, the most mysterious and the most needy from the patients` viewpoint of all therapeutic areas. This transaction will further build on Forest`s expertise in the field of NMDA receptors and the excitatory neurotransmitter glutamate."
About RGH-896 and NR2B:
RGH-896 is an orally active selective NR2B antagonist in Phase II development. NR2B is predominantly expressed on pain processing neuronal pathways. By blocking NR2B, RGH-896 and related compounds block pain signaling without interacting with other NMDA receptor subtypes thus potentially improving therapeutic index and side effect profile. Pre-clinical data with RGH-896 and related compounds support development in neuropathic pain and possibly other chronic pain conditions. The neuropathic pain market in the United States is estimated to exceed $2 Billion dollars annually. Currently available therapies are inadequate with room to improve efficacy, tolerability and dosing regimens. There is also an unmet need in other chronic pain conditions such as chronic osteoarthritis pain and low back pain which afflict a large number of patients and for which there are no wholly adequate therapies. A novel medication that is effective and well tolerated could expand this market and may have significant commercial potential.
About mGLUR1/5
Group 1 metabotropic glutamate receptors (mGluR1 and 5) are G-protein coupled receptors (GPCRs) that are activated by the excitatory neurotransmitter glutamate. These receptors are distinct from other glutamate receptors, e.g. ionotropic NMDA and AMPA receptors. Over the past decade, mGluRs have emerged as an exciting therapeutic target for a variety of psychiatric and neurological disorders including anxiety, depression, pain and other conditions. The potential advantages of targeting mGluR1/5 include improved efficacy and safety/tolerability compared with currently used therapeutics.
About Forest Laboratories Inc. and Its Products
Forest Laboratories` (http://www.frx.com) growing line of products includes: Lexapro(R) (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda(R) (memantine HCl), an N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate to severe Alzheimer`s disease; Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar* HCT(R) (olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; Campral(R)* (acamprosate calcium), a glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation in combination with psychosocial support; and Combunox(TM) (Oxycodone HCl and Ibuprofen), an opioid and NSAID combination indicated for the short-term management of acute, moderate to severe pain.
* Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is a registered trademark under license from Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in the Company`s SEC reports, including the Company`s Annual Report on Form 10-K for the fiscal year ended March 31, 2005 and on Form 10-Q for the periods ended June 30, 2005 and September 30, 2005.
About Gedeon Richter Limited
Gedeon Richter Ltd., (http://www.richter.hu) headquartered in Budapest/Hungary, is the leading pharmaceutical company in Hungary and one of the largest in Central Eastern Europe, with more than 3 billion US$ market capitalization. The company was founded in 1901. Gedeon Richter Ltd. plays the role of a regional multinational company in Central Eastern Europe and in the CIS, and has a growing presence through its commercial subsidiaries in key EU countries, and the USA. Two thirds of its annual sales of more than 599 million USD in 2004 are exported to 80 countries (EU, USA, Japan, Russia etc.) The company has a worldwide presence through its representative offices, subsidiaries in 30 countries. It has production facilities in Russia and Romania and Poland and there is one under construction in India. The product portfolio of the company includes more than 100 products and covers almost all important therapeutic areas. Based on its traditional skills in steroid chemistry, the company is a significant player in the gynaecological field worldwide. A significant part of the company`s turnover results from original drug research and development activity, which is focused on the diseases of the central nervous system since 1999.
SOURCE Forest Laboratories Holdings, Ltd.
Hallo, habe das eben gefunden.
Hat jemand ein Update zu dem "Alkoholpräparat"?
"Demnach stehe dem Alkoholismus-Medikament „Vivitrol“ möglicherweise eine große Zukunft bevor. Es sei denkbar, dass dieses 2012 bereits auf einen Umsatz von 350 Millionen Dollar pro Jahr komme. Derzeit vollziehe gerade das Konkurrenzpräparat „Campral“ von Forest Laboratories erfolgreich seinen Marktauftritt. Dieser könne erste Anhaltspunkte für die zu erwartende Nachfrage nach Vivitrol“ geben und zugleich den Weg für Medikamente mit derartigen Anwendungsgebieten ebnen."
Hat jemand ein Update zu dem "Alkoholpräparat"?
"Demnach stehe dem Alkoholismus-Medikament „Vivitrol“ möglicherweise eine große Zukunft bevor. Es sei denkbar, dass dieses 2012 bereits auf einen Umsatz von 350 Millionen Dollar pro Jahr komme. Derzeit vollziehe gerade das Konkurrenzpräparat „Campral“ von Forest Laboratories erfolgreich seinen Marktauftritt. Dieser könne erste Anhaltspunkte für die zu erwartende Nachfrage nach Vivitrol“ geben und zugleich den Weg für Medikamente mit derartigen Anwendungsgebieten ebnen."
[posting]19.577.541 von MrRipley am 06.01.06 21:21:37[/posting]Hallo Mr. Ripley,
in den ersten 6 Monaten seit Markeinführung wurde mit Campral ein Umsatz von ca. 9,5 Mio erzielt, davon 5,2 Mio. in den ersten 3 Monaten.
Auch bei Combunox, dem fast zeitgleich eingeführten Schmerzmittel, hielt sich der Umsatz mit nur ca. 1,8 Mio. in den ersten 6 Monaten in Grenzen.
Gruß
Balou
in den ersten 6 Monaten seit Markeinführung wurde mit Campral ein Umsatz von ca. 9,5 Mio erzielt, davon 5,2 Mio. in den ersten 3 Monaten.
Auch bei Combunox, dem fast zeitgleich eingeführten Schmerzmittel, hielt sich der Umsatz mit nur ca. 1,8 Mio. in den ersten 6 Monaten in Grenzen.
Gruß
Balou
@ all
was hatte den die deutsche merck damals als milestone payment für die zulassung bekomme ?
und ist campral offenkundig deutlich "schlechter" als vivitrol" ??
was hatte den die deutsche merck damals als milestone payment für die zulassung bekomme ?
und ist campral offenkundig deutlich "schlechter" als vivitrol" ??
[posting]19.585.907 von KnigRollo am 07.01.06 13:12:00[/posting]@ KnigRollo
zu 1)
Ich habe keine Ahnung.
zu 2)
die Frage ob nun Campral oder Vivitrol besser ist, ist meiner Meinung nach nebensächlich. Ich denke entscheidender ist, dass 18 Mio. Umsatz mit einem neuen Medikament bei einem Untermehmen mit über 3 Mrd. Umsatz nur ein kleines Zubrot sein können.
Was FRX für die Zukunft braucht, ist ein Medikament (oder besser mehrere) mit einem Potential > 500 Mio. Dollar.
Gruß
Balou
zu 1)
Ich habe keine Ahnung.
zu 2)
die Frage ob nun Campral oder Vivitrol besser ist, ist meiner Meinung nach nebensächlich. Ich denke entscheidender ist, dass 18 Mio. Umsatz mit einem neuen Medikament bei einem Untermehmen mit über 3 Mrd. Umsatz nur ein kleines Zubrot sein können.
Was FRX für die Zukunft braucht, ist ein Medikament (oder besser mehrere) mit einem Potential > 500 Mio. Dollar.
Gruß
Balou
wenn es in etwa gleich ist, dann taugt die Vertriebsmannschaft von forest nichts. aus dem campral könnte man doch was machen
Vielleicht ist es aber auch nur eine Frage des Marktes. Bekommt ein Alkoholiker in den Staaten das Medikament bezahlt, oder muss er selbst dafür aufkommen? (Was er wahrscheinlich nicht kann.)
Besser müssten sich solche Mittel z.B. in Deutschland verkaufen lassen. Hier kommt ja bekanntlich die Allgemeinheit für die Kosten auf.
Besser müssten sich solche Mittel z.B. in Deutschland verkaufen lassen. Hier kommt ja bekanntlich die Allgemeinheit für die Kosten auf.
campral ist ja eigentlich von der deutschen Merck, kenne nur die deutschen Verkaufszahlen nicht ??!
Forest Laboratories, Inc. has added a news release to its Investor Relations website.
Title: Mylan Laboratories and Forest Laboratories Announce Nebivolol Licensing Agreement
Date: 1/11/2006 6:15:00 PM
For a complete listing of our news releases, please click here
PITTSBURGH and NEW YORK, Jan. 11 /PRNewswire-FirstCall/ -- Mylan
Laboratories Inc. (NYSE: MYL) and Forest Laboratories Holdings, Ltd., a wholly
owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX) announced today that
the two companies have entered into an agreement for the commercialization,
development and distribution of Mylan`s novel beta blocker nebivolol in the
United States and Canada.
Under the terms of the agreement, Forest will make an upfront payment to
Mylan of $75 million as well as potential future milestone payments. In
addition, Mylan will also receive royalty payments based on nebivolol sales.
Forest will assume all nebivolol development expenses for current and future
development programs. Forest will be responsible for all sales and marketing
expenses and Mylan has retained an option to co-promote the product in the
future.
Robert J. Coury, Vice Chairman and Chief Executive Officer of Mylan,
commented: "We view Forest as an ideal partner for nebivolol. They meet all
of the criteria that we previously described, including impressive expertise
in the cardiovascular market, a proven track record in launching major branded
products and a commitment to invest in the research and development necessary
to maximize the full commercial potential of nebivolol."
Howard Solomon, Chairman and Chief Executive Officer of Forest, said: "We
are excited about the opportunity to market nebivolol, a highly beta-1
selective beta blocker which, based on the Phase III studies included in the
NDA filed by Mylan, appears to have favorable differentiating characteristics.
We are also particularly pleased to be partnering with Mylan and look forward
to a long-term collaboration with this excellent company."
On May 31, 2005, Mylan received an approvable letter from the U.S. Food
and Drug Administration (FDA) on its New Drug Application (NDA) for nebivolol
for the treatment of hypertension. Final approval is contingent upon
successfully satisfying additional FDA requirements included in the approvable
letter. Mylan has completed a pre-clinical study designed to address certain
questions posed by the FDA and is working towards submitting the results and
other information to the FDA for their review.
In addition, Mylan intends to submit a separate nebivolol NDA to the FDA
for the treatment of congestive heart failure. The submission, anticipated to
occur sometime during the second half of calendar year 2006, will be based on
data from the SENIORS clinical study conducted in Europe by the Menarini
Group.
About Nebivolol
Nebivolol is a novel beta blocker that is already approved and marketed in
more than 65 countries outside of North America. Mylan licensed the U.S. and
Canadian rights to nebivolol from Janssen Pharmaceutica N.V. in 2001, and has
obtained Janssen`s consent to sub-license nebivolol to Forest Laboratories in
those territories. Nebivolol is a highly-beta-1 selective beta-blocker, an
attribute which may provide certain advantages compared to currently marketed
beta blockers. Upon FDA approval Nebivolol will receive five years of
marketing exclusivity under the Hatch Waxman legislation. In addition there
is an issued U.S. pharmaceutical composition of matter patent set to expire in
2020 which may offer additional exclusivity.
About Mylan Laboratories
Mylan Laboratories Inc. is a leading pharmaceutical company with three
principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc.
and UDL Laboratories, Inc., that develop, license, manufacture, market and
distribute an extensive line of generic and proprietary products.
About Forest Laboratories Inc. and Its Products
Forest Laboratories` (www.frx.com) growing line of products includes:
Lexapro(R) (escitalopram oxalate), an SSRI antidepressant indicated for the
initial and maintenance treatment of major depressive disorder and for
generalized anxiety disorder in adults; Namenda(R) (memantine HCl), an N-
methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of
moderate to severe Alzheimer`s disease; Benicar(R) * (olmesartan medoxomil),
an angiotensin receptor blocker indicated for the treatment of hypertension;
Benicar* HCT(R) (olmesartan medoxomil hydrochlorothiazide), an angiotensin
receptor blocker and diuretic combination product indicated for the second-
line treatment of hypertension; Campral(R) * (acamprosate calcium), a
glutamate receptor modulator, indicated for the maintenance of abstinence from
alcohol in patients with alcohol dependence who are abstinent at treatment
initiation in combination with psychosocial support; and Combunox(TM)
(Oxycodone HCl and Ibuprofen), an opioid and NSAID combination indicated for
the short-term management of acute, moderate to severe pain.
* Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is
a registered trademark under license from Merck Sante s.a.s., subsidiary of
Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Because these statements involve a
number of risks and uncertainties, actual future results may differ materially
from those expressed or implied by such forward-looking statements. Factors
that could cause or contribute to such differences include, but are not
limited to the difficulty of predicting FDA approvals, acceptance and demand
for new pharmaceutical products, challenges relating to intellectual property
protection, the impact of competitive products and pricing, the timely
development and launch of new products and the risk factors listed from time
to time in both companies` SEC reports, including their Annual Reports on Form
10-K for the fiscal year ended March 31, 2005 and Quarterly Reports on Form
10-Q for the periods ended June 30, 2005 and September 30, 2005.
SOURCE Mylan Laboratories Inc.; Forest Laboratories, Inc.
-0- 01/11/2006
/CONTACT: Patrick Fitzgerald of Mylan Laboratories Inc., +1-724-514-1800;
or Charles E. Triano, Vice President-Investor Relations of Forest
Laboratories, Inc., +1-212-224-6714/
/Web site: http://www.mylan.com/
(MYL FRX)
CO: Mylan Laboratories Inc.; Forest Laboratories Holdings, Ltd.; Forest
Laboratories, Inc.
ST: Pennsylvania, New York
IN: HEA MTC
SU: LIC
Title: Mylan Laboratories and Forest Laboratories Announce Nebivolol Licensing Agreement
Date: 1/11/2006 6:15:00 PM
For a complete listing of our news releases, please click here
PITTSBURGH and NEW YORK, Jan. 11 /PRNewswire-FirstCall/ -- Mylan
Laboratories Inc. (NYSE: MYL) and Forest Laboratories Holdings, Ltd., a wholly
owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX) announced today that
the two companies have entered into an agreement for the commercialization,
development and distribution of Mylan`s novel beta blocker nebivolol in the
United States and Canada.
Under the terms of the agreement, Forest will make an upfront payment to
Mylan of $75 million as well as potential future milestone payments. In
addition, Mylan will also receive royalty payments based on nebivolol sales.
Forest will assume all nebivolol development expenses for current and future
development programs. Forest will be responsible for all sales and marketing
expenses and Mylan has retained an option to co-promote the product in the
future.
Robert J. Coury, Vice Chairman and Chief Executive Officer of Mylan,
commented: "We view Forest as an ideal partner for nebivolol. They meet all
of the criteria that we previously described, including impressive expertise
in the cardiovascular market, a proven track record in launching major branded
products and a commitment to invest in the research and development necessary
to maximize the full commercial potential of nebivolol."
Howard Solomon, Chairman and Chief Executive Officer of Forest, said: "We
are excited about the opportunity to market nebivolol, a highly beta-1
selective beta blocker which, based on the Phase III studies included in the
NDA filed by Mylan, appears to have favorable differentiating characteristics.
We are also particularly pleased to be partnering with Mylan and look forward
to a long-term collaboration with this excellent company."
On May 31, 2005, Mylan received an approvable letter from the U.S. Food
and Drug Administration (FDA) on its New Drug Application (NDA) for nebivolol
for the treatment of hypertension. Final approval is contingent upon
successfully satisfying additional FDA requirements included in the approvable
letter. Mylan has completed a pre-clinical study designed to address certain
questions posed by the FDA and is working towards submitting the results and
other information to the FDA for their review.
In addition, Mylan intends to submit a separate nebivolol NDA to the FDA
for the treatment of congestive heart failure. The submission, anticipated to
occur sometime during the second half of calendar year 2006, will be based on
data from the SENIORS clinical study conducted in Europe by the Menarini
Group.
About Nebivolol
Nebivolol is a novel beta blocker that is already approved and marketed in
more than 65 countries outside of North America. Mylan licensed the U.S. and
Canadian rights to nebivolol from Janssen Pharmaceutica N.V. in 2001, and has
obtained Janssen`s consent to sub-license nebivolol to Forest Laboratories in
those territories. Nebivolol is a highly-beta-1 selective beta-blocker, an
attribute which may provide certain advantages compared to currently marketed
beta blockers. Upon FDA approval Nebivolol will receive five years of
marketing exclusivity under the Hatch Waxman legislation. In addition there
is an issued U.S. pharmaceutical composition of matter patent set to expire in
2020 which may offer additional exclusivity.
About Mylan Laboratories
Mylan Laboratories Inc. is a leading pharmaceutical company with three
principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc.
and UDL Laboratories, Inc., that develop, license, manufacture, market and
distribute an extensive line of generic and proprietary products.
About Forest Laboratories Inc. and Its Products
Forest Laboratories` (www.frx.com) growing line of products includes:
Lexapro(R) (escitalopram oxalate), an SSRI antidepressant indicated for the
initial and maintenance treatment of major depressive disorder and for
generalized anxiety disorder in adults; Namenda(R) (memantine HCl), an N-
methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of
moderate to severe Alzheimer`s disease; Benicar(R) * (olmesartan medoxomil),
an angiotensin receptor blocker indicated for the treatment of hypertension;
Benicar* HCT(R) (olmesartan medoxomil hydrochlorothiazide), an angiotensin
receptor blocker and diuretic combination product indicated for the second-
line treatment of hypertension; Campral(R) * (acamprosate calcium), a
glutamate receptor modulator, indicated for the maintenance of abstinence from
alcohol in patients with alcohol dependence who are abstinent at treatment
initiation in combination with psychosocial support; and Combunox(TM)
(Oxycodone HCl and Ibuprofen), an opioid and NSAID combination indicated for
the short-term management of acute, moderate to severe pain.
* Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is
a registered trademark under license from Merck Sante s.a.s., subsidiary of
Merck KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Because these statements involve a
number of risks and uncertainties, actual future results may differ materially
from those expressed or implied by such forward-looking statements. Factors
that could cause or contribute to such differences include, but are not
limited to the difficulty of predicting FDA approvals, acceptance and demand
for new pharmaceutical products, challenges relating to intellectual property
protection, the impact of competitive products and pricing, the timely
development and launch of new products and the risk factors listed from time
to time in both companies` SEC reports, including their Annual Reports on Form
10-K for the fiscal year ended March 31, 2005 and Quarterly Reports on Form
10-Q for the periods ended June 30, 2005 and September 30, 2005.
SOURCE Mylan Laboratories Inc.; Forest Laboratories, Inc.
-0- 01/11/2006
/CONTACT: Patrick Fitzgerald of Mylan Laboratories Inc., +1-724-514-1800;
or Charles E. Triano, Vice President-Investor Relations of Forest
Laboratories, Inc., +1-212-224-6714/
/Web site: http://www.mylan.com/
(MYL FRX)
CO: Mylan Laboratories Inc.; Forest Laboratories Holdings, Ltd.; Forest
Laboratories, Inc.
ST: Pennsylvania, New York
IN: HEA MTC
SU: LIC
[posting]19.671.386 von grigri4 am 12.01.06 10:03:48[/posting]Im Gegensatz zu Altana tut sich hier wenigstens was.
(Antwort auf Beitrag Nr. 19.671.756 - erstellt von betterthantherest am 12.01.06 10:24:18)
Hallo better,
nächste Woche wird Nikolaus Schweickart eine Rede an der TU in München zum Thema Biotechnologie halten. Da werde ich ihn mir mal in Natur ansehen. Bisher halte ich viel von ihm. Schade ist, dass er nächstes Jahr wohl aus seinem Amt ausscheidet.
Hoffentlich setzt der Nachfolger/ setzen die Nachfolger die Akzente ähnlich. Ich habe Altana bisher nicht verkauft, weil sie nur moderat bewertet sind und meiner Ansicht nach trotz aller Probleme ein gutes Unternehmen sind. Hier warte ich im Moment eigentlich nur darauf, dass wie du schon angesprochen hast, bei einer Aufspaltung unter Umständen die Chemiesparte (weil sehr klein) unter Druck kommt und sich dann ein möglicherweise guter Kaufzeitpunkt bieten könnte. Bei Altana ist man stolz darauf in beiden Sparten zu den profitabelsten Unternehmen in Europa zu gehören, worauf ich ziemlich viel Wert lege.
Über Forest Labs freue ich mich auch. Die habe ich auch sehr hoch gewichtet in meinen Depots. Wichtig ist, dass das Management hier auch einen sehr kompetenten Eindruck macht.
Gruß grigri
Hallo better,
nächste Woche wird Nikolaus Schweickart eine Rede an der TU in München zum Thema Biotechnologie halten. Da werde ich ihn mir mal in Natur ansehen. Bisher halte ich viel von ihm. Schade ist, dass er nächstes Jahr wohl aus seinem Amt ausscheidet.
Hoffentlich setzt der Nachfolger/ setzen die Nachfolger die Akzente ähnlich. Ich habe Altana bisher nicht verkauft, weil sie nur moderat bewertet sind und meiner Ansicht nach trotz aller Probleme ein gutes Unternehmen sind. Hier warte ich im Moment eigentlich nur darauf, dass wie du schon angesprochen hast, bei einer Aufspaltung unter Umständen die Chemiesparte (weil sehr klein) unter Druck kommt und sich dann ein möglicherweise guter Kaufzeitpunkt bieten könnte. Bei Altana ist man stolz darauf in beiden Sparten zu den profitabelsten Unternehmen in Europa zu gehören, worauf ich ziemlich viel Wert lege.
Über Forest Labs freue ich mich auch. Die habe ich auch sehr hoch gewichtet in meinen Depots. Wichtig ist, dass das Management hier auch einen sehr kompetenten Eindruck macht.
Gruß grigri
[posting]19.675.581 von grigri4 am 12.01.06 13:52:00[/posting]Ich würde mir zu Altana eine Meldung, wie die, zur Zusammenarbeit zwischen Forest und Mylan wünschen.
Herr Schweikart hätte jedenfalls für seine bisher erbrachte Leistung einen besseren Abgang verdient.
Herr Schweikart hätte jedenfalls für seine bisher erbrachte Leistung einen besseren Abgang verdient.
Forest Laboratories, Inc. has added a news release to its Investor Relations website.
Title: Forest Laboratories, Inc. Reports Q3`06 Diluted Earnings Per Share of $0.57 Including $0.05 Per Share Licensing Payment
Date: 1/17/2006 8:09:00 AM
For a complete listing of our news releases, please click here
NEW YORK, Jan. 17 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX), an international pharmaceutical manufacturer and marketer, today
reported financial results for its fiscal third quarter ended December 31,
2005.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Revenues for the quarter decreased 9% to $757,830,000 from $832,343,000 in
the year-ago period. Revenues were comprised of net sales of $714,887,000, a
decrease of 10% from $795,047,000 in the year-ago period, contract revenue of
$28,373,000, an increase of 19% from $23,813,000 in the year-ago period and
other income of $14,570,000, which increased 8% from $13,483,000 in the year-
ago period.
Sales in the quarter included $485,687,000 for Forest`s antidepressant
franchise which was comprised of $480,707,000 of Lexapro(R) (escitalopram
oxalate), an SSRI indicated for the initial and maintenance treatment of major
depressive disorder and generalized anxiety disorder in adults, $4,823,000 of
Celexa(R) (citalopram HBr), an antidepressant, and $157,000 of generic
citalopram. The year-ago period included $560,640,000 of antidepressant
franchise sales which was comprised of $427,118,000 of Lexapro, $129,812,000
of branded Celexa and $3,710,000 of generic citalopram. Sales of Namenda(R),
an NMDA receptor antagonist for the treatment of moderate to severe
Alzheimer`s disease, totaled $124,022,000 in the quarter compared to sales of
$100,603,000 in last year`s third quarter.
Other income included earnings from the co-promotion agreement with Sankyo
Pharma for Benicar(R)* and Benicar HCT(R), antihypertensive therapies, of
$28,290,000 and interest income of $14,229,000. Additional contract revenue
and other income totaled $424,000.
Selling, general and administrative expenses increased 3% to $250,725,000.
Research and development spending increased 22% to $94,188,000 during the
quarter and included a one-time upfront payment equal to $0.05 per share to
Gedeon Richter for U.S. and Canadian rights to RGH-896, a compound being
developed for the treatment of chronic pain and other CNS conditions and a
group of novel compounds that target the group 1 metabotropic glutamate
receptors (mGLUR1/5). The year-ago period also included an upfront payment to
Gedeon Richter Limited for the U.S. and Canadian rights to RGH-188, a compound
being investigated for the treatment of schizophrenia, bipolar mania and other
psychiatric disorders.
Net income in the current quarter decreased by 25% to $195,163,000 as
compared to $260,805,000 reported in the third quarter of the prior year.
Diluted earnings per share decreased 19% to $0.57 in the current quarter
including the $.05 per share payment to Gedeon Richter, compared to earnings
per share of $0.70 in the year-ago period.
Fully diluted shares outstanding for the third quarter were 340,663,000, a
reduction of 30,975,000 shares due mainly to the Company`s ongoing share
repurchase program. During the quarter the Company purchased 12,343,300
shares under its current 25 million share authorization. The Company expects
to complete the repurchase of the 10,256,700 shares remaining under the
current program during the quarter ending March 31, 2006
Nine-month results
Revenue for the nine months ended December 31, 2005 decreased 12% to
$2,206,068,000 from $2,506,403,000 in the prior year.
Net income for the nine months ended December 31, 2005 decreased 22% to
$616,624,000 from net income of $786,050,000 reported in the nine months of
the prior year. Diluted earnings per share decreased 14% to $1.79 in the
current year`s first nine months as compared to diluted earnings per share of
$2.09 for last year`s nine months.
Howard Solomon, Chairman and Chief Executive Officer of Forest, said:
"During the quarter sales for our key promoted products increased compared to
the prior year. Our additional collaborations with Gedeon Richter Limited
announced during the quarter are important pipeline additions in the CNS area
in which Gedeon Richter focuses and which produced the antipsychotic licensed
from Gedeon Richter in 2004 which is now in clinical testing. With these new
collaborations we will be exploring areas such as chronic pain, anxiety,
depression and related conditions. These programs strengthen our longer-term
development pipeline while the just announced licensing agreement with Mylan
Laboratories Inc. for nebivolol, a beta-blocker for the treatment of
hypertension and potentially congestive heart failure, represents a
significant near-term product opportunity for the Company. We continue to
evaluate additional product opportunities that could be commercialized near,
mid, and longer term."
Mr. Solomon continued: "Regarding our patent litigation trial against IVAX
Pharmaceuticals, Inc., it is scheduled to begin on March 15, 2006 in U.S.
Federal District Court in Delaware and we continue to remain confident in the
validity of the Lexapro patent."
Fiscal 2006 Guidance
The Company continues to expect adjusted fully diluted earnings per share
of approximately $2.30 for the fiscal year ending March 31, 2006, excluding
the effect of the one-time tax benefit recorded in the fiscal first quarter.
Including the one-time tax benefit, reported fully diluted earnings per share
are projected to be approximately $2.40. The Company continues to expect that
revenues will total approximately $3 billion and forecasts that net sales will
total approximately $2.8 billion. The Company currently forecasts Lexapro
sales of approximately $1.9 billion and Namenda sales of approximately $500
million.
Research and development spending is now forecast at approximately $280
million, a reduction of $40 million in the projection from last quarter due
to the timing of various potential milestone payments shifting into next
fiscal year. The projection includes the payment to Gedeon Richter which was
made in the just completed quarter. Selling, general and administrative
expenses are projected to grow to just over $1.03 billion.
The upfront payment to Gedeon Richter of $0.05 per share in the just-
completed quarter was not included in the Company`s prior guidance nor was any
impact from the ongoing share repurchase program. These two factors are
projected to offset each other and are now included in the $2.30 per share
estimate.
Forest will host a conference call at 10:00 AM EST today to discuss the
results. The conference call will be webcast live beginning at 10:00 AM EST
on the Company`s website at http://www.frx.comand also on the website
http://www.streetevents.com. Please log on to either website at least fifteen
minutes prior to the conference call as it may be necessary to download
software to access the call. A replay of the conference call will be
available until January 31, 2006 at both websites and also by dialing
1-800-642-1687 (US investors) or +1-706-645-9291 (international investors)
passcode 3995668.
About Forest Laboratories and Its Products
Forest Laboratories` growing line of products includes: Lexapro(R)
(escitalopram oxalate), an SSRI antidepressant indicated for the initial and
maintenance treatment of major depressive disorder and for generalized anxiety
disorder in adults; Namenda(R) (memantine HCl), an N-methyl-D-aspartate
(NMDA)-receptor antagonist indicated for the treatment of moderate to severe
Alzheimer`s disease; Benicar(R) * (olmesartan medoxomil), an angiotensin
receptor blocker indicated for the treatment of hypertension; Benicar* HCT(R)
(olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker
and diuretic combination product indicated for the second-line treatment of
hypertension; Campral(R) * (acamprosate calcium), a glutamate receptor
modulator, indicated for the maintenance of abstinence from alcohol in
patients with alcohol dependence who are abstinent at treatment initiation in
combination with psychosocial support; and Combunox(TM) (Oxycodone HCl and
Ibuprofen), an opioid and NSAID combination indicated for the short-term
management of acute, moderate to severe pain.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA approvals,
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products and the risk factors listed from time to time in the Company`s SEC
reports, including the Company`s Annual Report on Form 10-K for the fiscal
year ended March 31, 2005 and on Form 10-Q for the periods ended June 30, 2005
and September 30, 2005.
* Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is
a registered trademark under license from Merck Sante s.a.s., subsidiary of
Merck KGaA, Darmstadt, Germany.
FOREST LABORATORIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(Unaudited)
THREE MONTHS NINE MONTHS
ENDED DECEMBER 31 ENDED DECEMBER 31
(In thousands, except per share amounts)
2005 2004 2005 2004
Revenues:
Net sales $714,887 $795,047 $2,081,173 $2,434,123
Contract revenue 28,373 23,813 86,945 39,055
Other income 14,570 13,483 37,950 33,225
Net revenues 757,830 832,343 2,206,068 2,506,403
Costs and expenses:
Cost of goods sold 165,875 176,431 483,136 545,298
Selling, general and
administrative 250,725 242,863 772,435 727,256
Research and
development 94,188 77,393 216,054 231,901
510,788 496,687 1,471,625 1,504,455
Income before income
tax expense 247,042 335,656 734,443 1,001,948
Income tax expense 51,879 74,851 117,819 215,898
Net income $195,163 $260,805 $616,624 $786,050
Net income per share:
Basic $0.58 $0.71 $1.81 $2.13
Diluted $0.57 $0.70 $1.79 $2.09
Weighted average
number of shares
outstanding:
Basic 336,890 364,914 340,160 368,227
Diluted 340,663 371,638 344,801 376,930
SOURCE Forest Laboratories, Inc.
-0- 01/17/2006
/CONTACT: Charles E. Triano, Vice President - Investor Relations, of
Forest Laboratories, Inc., +1-212-224-6714, or charles.triano@frx.com/
/Photo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO /
/Web site: http://www.frx.com /
(FRX)
CO: Forest Laboratories, Inc.
ST: New York
IN: MTC HEA BIO
SU: ERN ERP CCA
MV-AA
-- NYTU052 --
3808 01/17/2006 08:09 EST http://www.prnewswire.com
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Title: Forest Laboratories, Inc. Reports Q3`06 Diluted Earnings Per Share of $0.57 Including $0.05 Per Share Licensing Payment
Date: 1/17/2006 8:09:00 AM
For a complete listing of our news releases, please click here
NEW YORK, Jan. 17 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX), an international pharmaceutical manufacturer and marketer, today
reported financial results for its fiscal third quarter ended December 31,
2005.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Revenues for the quarter decreased 9% to $757,830,000 from $832,343,000 in
the year-ago period. Revenues were comprised of net sales of $714,887,000, a
decrease of 10% from $795,047,000 in the year-ago period, contract revenue of
$28,373,000, an increase of 19% from $23,813,000 in the year-ago period and
other income of $14,570,000, which increased 8% from $13,483,000 in the year-
ago period.
Sales in the quarter included $485,687,000 for Forest`s antidepressant
franchise which was comprised of $480,707,000 of Lexapro(R) (escitalopram
oxalate), an SSRI indicated for the initial and maintenance treatment of major
depressive disorder and generalized anxiety disorder in adults, $4,823,000 of
Celexa(R) (citalopram HBr), an antidepressant, and $157,000 of generic
citalopram. The year-ago period included $560,640,000 of antidepressant
franchise sales which was comprised of $427,118,000 of Lexapro, $129,812,000
of branded Celexa and $3,710,000 of generic citalopram. Sales of Namenda(R),
an NMDA receptor antagonist for the treatment of moderate to severe
Alzheimer`s disease, totaled $124,022,000 in the quarter compared to sales of
$100,603,000 in last year`s third quarter.
Other income included earnings from the co-promotion agreement with Sankyo
Pharma for Benicar(R)* and Benicar HCT(R), antihypertensive therapies, of
$28,290,000 and interest income of $14,229,000. Additional contract revenue
and other income totaled $424,000.
Selling, general and administrative expenses increased 3% to $250,725,000.
Research and development spending increased 22% to $94,188,000 during the
quarter and included a one-time upfront payment equal to $0.05 per share to
Gedeon Richter for U.S. and Canadian rights to RGH-896, a compound being
developed for the treatment of chronic pain and other CNS conditions and a
group of novel compounds that target the group 1 metabotropic glutamate
receptors (mGLUR1/5). The year-ago period also included an upfront payment to
Gedeon Richter Limited for the U.S. and Canadian rights to RGH-188, a compound
being investigated for the treatment of schizophrenia, bipolar mania and other
psychiatric disorders.
Net income in the current quarter decreased by 25% to $195,163,000 as
compared to $260,805,000 reported in the third quarter of the prior year.
Diluted earnings per share decreased 19% to $0.57 in the current quarter
including the $.05 per share payment to Gedeon Richter, compared to earnings
per share of $0.70 in the year-ago period.
Fully diluted shares outstanding for the third quarter were 340,663,000, a
reduction of 30,975,000 shares due mainly to the Company`s ongoing share
repurchase program. During the quarter the Company purchased 12,343,300
shares under its current 25 million share authorization. The Company expects
to complete the repurchase of the 10,256,700 shares remaining under the
current program during the quarter ending March 31, 2006
Nine-month results
Revenue for the nine months ended December 31, 2005 decreased 12% to
$2,206,068,000 from $2,506,403,000 in the prior year.
Net income for the nine months ended December 31, 2005 decreased 22% to
$616,624,000 from net income of $786,050,000 reported in the nine months of
the prior year. Diluted earnings per share decreased 14% to $1.79 in the
current year`s first nine months as compared to diluted earnings per share of
$2.09 for last year`s nine months.
Howard Solomon, Chairman and Chief Executive Officer of Forest, said:
"During the quarter sales for our key promoted products increased compared to
the prior year. Our additional collaborations with Gedeon Richter Limited
announced during the quarter are important pipeline additions in the CNS area
in which Gedeon Richter focuses and which produced the antipsychotic licensed
from Gedeon Richter in 2004 which is now in clinical testing. With these new
collaborations we will be exploring areas such as chronic pain, anxiety,
depression and related conditions. These programs strengthen our longer-term
development pipeline while the just announced licensing agreement with Mylan
Laboratories Inc. for nebivolol, a beta-blocker for the treatment of
hypertension and potentially congestive heart failure, represents a
significant near-term product opportunity for the Company. We continue to
evaluate additional product opportunities that could be commercialized near,
mid, and longer term."
Mr. Solomon continued: "Regarding our patent litigation trial against IVAX
Pharmaceuticals, Inc., it is scheduled to begin on March 15, 2006 in U.S.
Federal District Court in Delaware and we continue to remain confident in the
validity of the Lexapro patent."
Fiscal 2006 Guidance
The Company continues to expect adjusted fully diluted earnings per share
of approximately $2.30 for the fiscal year ending March 31, 2006, excluding
the effect of the one-time tax benefit recorded in the fiscal first quarter.
Including the one-time tax benefit, reported fully diluted earnings per share
are projected to be approximately $2.40. The Company continues to expect that
revenues will total approximately $3 billion and forecasts that net sales will
total approximately $2.8 billion. The Company currently forecasts Lexapro
sales of approximately $1.9 billion and Namenda sales of approximately $500
million.
Research and development spending is now forecast at approximately $280
million, a reduction of $40 million in the projection from last quarter due
to the timing of various potential milestone payments shifting into next
fiscal year. The projection includes the payment to Gedeon Richter which was
made in the just completed quarter. Selling, general and administrative
expenses are projected to grow to just over $1.03 billion.
The upfront payment to Gedeon Richter of $0.05 per share in the just-
completed quarter was not included in the Company`s prior guidance nor was any
impact from the ongoing share repurchase program. These two factors are
projected to offset each other and are now included in the $2.30 per share
estimate.
Forest will host a conference call at 10:00 AM EST today to discuss the
results. The conference call will be webcast live beginning at 10:00 AM EST
on the Company`s website at http://www.frx.comand also on the website
http://www.streetevents.com. Please log on to either website at least fifteen
minutes prior to the conference call as it may be necessary to download
software to access the call. A replay of the conference call will be
available until January 31, 2006 at both websites and also by dialing
1-800-642-1687 (US investors) or +1-706-645-9291 (international investors)
passcode 3995668.
About Forest Laboratories and Its Products
Forest Laboratories` growing line of products includes: Lexapro(R)
(escitalopram oxalate), an SSRI antidepressant indicated for the initial and
maintenance treatment of major depressive disorder and for generalized anxiety
disorder in adults; Namenda(R) (memantine HCl), an N-methyl-D-aspartate
(NMDA)-receptor antagonist indicated for the treatment of moderate to severe
Alzheimer`s disease; Benicar(R) * (olmesartan medoxomil), an angiotensin
receptor blocker indicated for the treatment of hypertension; Benicar* HCT(R)
(olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker
and diuretic combination product indicated for the second-line treatment of
hypertension; Campral(R) * (acamprosate calcium), a glutamate receptor
modulator, indicated for the maintenance of abstinence from alcohol in
patients with alcohol dependence who are abstinent at treatment initiation in
combination with psychosocial support; and Combunox(TM) (Oxycodone HCl and
Ibuprofen), an opioid and NSAID combination indicated for the short-term
management of acute, moderate to severe pain.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA approvals,
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products and the risk factors listed from time to time in the Company`s SEC
reports, including the Company`s Annual Report on Form 10-K for the fiscal
year ended March 31, 2005 and on Form 10-Q for the periods ended June 30, 2005
and September 30, 2005.
* Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is
a registered trademark under license from Merck Sante s.a.s., subsidiary of
Merck KGaA, Darmstadt, Germany.
FOREST LABORATORIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(Unaudited)
THREE MONTHS NINE MONTHS
ENDED DECEMBER 31 ENDED DECEMBER 31
(In thousands, except per share amounts)
2005 2004 2005 2004
Revenues:
Net sales $714,887 $795,047 $2,081,173 $2,434,123
Contract revenue 28,373 23,813 86,945 39,055
Other income 14,570 13,483 37,950 33,225
Net revenues 757,830 832,343 2,206,068 2,506,403
Costs and expenses:
Cost of goods sold 165,875 176,431 483,136 545,298
Selling, general and
administrative 250,725 242,863 772,435 727,256
Research and
development 94,188 77,393 216,054 231,901
510,788 496,687 1,471,625 1,504,455
Income before income
tax expense 247,042 335,656 734,443 1,001,948
Income tax expense 51,879 74,851 117,819 215,898
Net income $195,163 $260,805 $616,624 $786,050
Net income per share:
Basic $0.58 $0.71 $1.81 $2.13
Diluted $0.57 $0.70 $1.79 $2.09
Weighted average
number of shares
outstanding:
Basic 336,890 364,914 340,160 368,227
Diluted 340,663 371,638 344,801 376,930
SOURCE Forest Laboratories, Inc.
-0- 01/17/2006
/CONTACT: Charles E. Triano, Vice President - Investor Relations, of
Forest Laboratories, Inc., +1-212-224-6714, or charles.triano@frx.com/
/Photo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO /
/Web site: http://www.frx.com /
(FRX)
CO: Forest Laboratories, Inc.
ST: New York
IN: MTC HEA BIO
SU: ERN ERP CCA
MV-AA
-- NYTU052 --
3808 01/17/2006 08:09 EST http://www.prnewswire.com
------------------------------------------------------------
If you are unable to click on the link above, please copy and paste the URL below into a web browser
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------------------------------------------------------------
Thomson Financial Inc 22 Thomson Place Boston, MA 02210
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Der Unterschied macht`s.
(Hoffentlich)
Forest Labs: Is Different Better?
By Stephen D. Simpson, CFA (TMFWildWeasel)
January 17, 2006
Like a woodsman with a big ax, generic competition continues to cut away at Forest Labs` (NYSE: FRX) profitability. And it`ll still be a while before Forest investors can look for the kind of growth to which they`ve become accustomed over the history of this company.
Revenue fell by about 9% this quarter. Yes, that`s a bit worse than expected, but not by a truly significant degree. Sales in the antidepressant franchise tumbled by 13%, as growth in Lexapro couldn`t offset Celexa revenue lost to generic competition. But Namenda, a drug for the treatment of Alzheimer`s disease, continued to be something of a bright spot, with sales growing more than 23%.
While revenue shrinks, the company continues to run and build its business. Sales, general, and administrative expenses rose 3% in the quarter, and research and development was 22% higher. In turn, there was a 25% drop in net income, which, offset by share repurchases, translated into a 19% drop in earnings per share.
Based on the emails I`ve received, I`m sensing that there`s a bit of confusion about what Forest is and how it operates, so I`ll devote a little time here to this subject. In a very real sense, Forest is a specialist in pharmaceutical development and marketing. It looks for companies -- often smaller ones overseas -- that can`t, or don`t want to, finish clinical development of a drug and/or market it themselves. Forest then in-licenses these compounds, finishes the clinical development, and markets them in North America in exchange for paying certain upfront fees, milestones, and royalties.
The advantage is that Forest doesn`t have to pay for the infrastructure of a basic science research effort -- it takes the fruits of other people`s basic science and carries it forward. The bad news is that it has virtually no internal pipeline of its own -- it has to in-license compounds to replenish the pipeline. Historically, though, that bad news hasn`t been all that bad: There are always smaller pharmaceuticals and biotechs that lack the infrastructure (or willingness) to bring their own products to market.
Forest now has a fair number of interesting products in the pipeline, but with the exception of the recently licensed drug nebivolol, they won`t likely be hitting the market until 2007 and beyond. Of course, Forest will also begin a period of easier year-over-year comparisons (the anniversary of falling Celexa sales), and that might ease the perceptions around this stock. Competitors such as Lilly (NYSE: LLY) and GlaxoSmithKline (NYSE: GSK) will remain formidable, and the patent challenge on Lexapro from Ivax (AMEX: IVX) is a valid worry, but investors shouldn`t count Forest out just yet.
http://www.fool.com/News/mft/2006/mft06011710.htm
(Hoffentlich)
Forest Labs: Is Different Better?
By Stephen D. Simpson, CFA (TMFWildWeasel)
January 17, 2006
Like a woodsman with a big ax, generic competition continues to cut away at Forest Labs` (NYSE: FRX) profitability. And it`ll still be a while before Forest investors can look for the kind of growth to which they`ve become accustomed over the history of this company.
Revenue fell by about 9% this quarter. Yes, that`s a bit worse than expected, but not by a truly significant degree. Sales in the antidepressant franchise tumbled by 13%, as growth in Lexapro couldn`t offset Celexa revenue lost to generic competition. But Namenda, a drug for the treatment of Alzheimer`s disease, continued to be something of a bright spot, with sales growing more than 23%.
While revenue shrinks, the company continues to run and build its business. Sales, general, and administrative expenses rose 3% in the quarter, and research and development was 22% higher. In turn, there was a 25% drop in net income, which, offset by share repurchases, translated into a 19% drop in earnings per share.
Based on the emails I`ve received, I`m sensing that there`s a bit of confusion about what Forest is and how it operates, so I`ll devote a little time here to this subject. In a very real sense, Forest is a specialist in pharmaceutical development and marketing. It looks for companies -- often smaller ones overseas -- that can`t, or don`t want to, finish clinical development of a drug and/or market it themselves. Forest then in-licenses these compounds, finishes the clinical development, and markets them in North America in exchange for paying certain upfront fees, milestones, and royalties.
The advantage is that Forest doesn`t have to pay for the infrastructure of a basic science research effort -- it takes the fruits of other people`s basic science and carries it forward. The bad news is that it has virtually no internal pipeline of its own -- it has to in-license compounds to replenish the pipeline. Historically, though, that bad news hasn`t been all that bad: There are always smaller pharmaceuticals and biotechs that lack the infrastructure (or willingness) to bring their own products to market.
Forest now has a fair number of interesting products in the pipeline, but with the exception of the recently licensed drug nebivolol, they won`t likely be hitting the market until 2007 and beyond. Of course, Forest will also begin a period of easier year-over-year comparisons (the anniversary of falling Celexa sales), and that might ease the perceptions around this stock. Competitors such as Lilly (NYSE: LLY) and GlaxoSmithKline (NYSE: GSK) will remain formidable, and the patent challenge on Lexapro from Ivax (AMEX: IVX) is a valid worry, but investors shouldn`t count Forest out just yet.
http://www.fool.com/News/mft/2006/mft06011710.htm
Forest Labs bleibt seinem Konzept treu und sucht sich Partnerschaften mit Firmen, die Präparate in fortgeschrittenen Entwicklungsstadien haben, um diese dann in den USA zu vermarkten.
----
LOUISVILLE, Colo. and NEW YORK, Feb. 13 /PRNewswire-FirstCall/ -- Replidyne, Inc., a privately held biopharmaceutical company and Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX - News) announced today that the two companies have entered into an agreement for the commercialization, development and distribution of Replidyne`s new oral antibiotic, faropenem medoxomil, in the United States.
http://biz.yahoo.com/prnews/060213/nym057.html?.v=36
----
Gruß
Balou
----
LOUISVILLE, Colo. and NEW YORK, Feb. 13 /PRNewswire-FirstCall/ -- Replidyne, Inc., a privately held biopharmaceutical company and Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX - News) announced today that the two companies have entered into an agreement for the commercialization, development and distribution of Replidyne`s new oral antibiotic, faropenem medoxomil, in the United States.
http://biz.yahoo.com/prnews/060213/nym057.html?.v=36
----
Gruß
Balou
Antwort auf Beitrag Nr.: 20.207.384 von Balou2 am 14.02.06 21:24:06Nachrichten von gestern
NEW YORK and BARCELONA, Spain, April 10 /PRNewswire-FirstCall/ -- Forest
Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories,
Inc. (NYSE: FRX) and Almirall, a privately held pharmaceutical company
headquartered in Barcelona, Spain, announced today that the two companies have
entered an agreement to develop, market and distribute Almirall's novel
inhaled, long-acting muscarinic antagonist, LAS34273, in the United States.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
The innovative LAS34273 is now entering Phase III studies in the United
States and Europe for chronic obstructive pulmonary disease (COPD). LAS34273
has been evaluated in Phase II studies that demonstrate that it has a fast
onset of action and provides 24 hours of bronchodilation. LAS 34273 is
designed to have a very specific action in the lungs resulting in a low level
of systemic exposure. Studies to date including cardiovascular safety studies
support a favorable side effects profile. The product is being developed in a
Multi Dose-Dry Powder Inhaler (MDPI) which represents an improvement in drug
delivery over currently available devices.
This new treatment promises to provide relief for the many sufferers of
COPD. According to the World Health Organisation, COPD is the 5th leading
cause of death worldwide and the fourth in the US. Affecting over 12 million
adults in the US, it is also estimated that a further 24 million show some
evidence of impaired lung function highlighting a clear under diagnoses of
COPD.(1) The condition, which is mainly caused by smoking, results in damage
to the airways which triggers symptoms such as cough, breathlessness, excess
sputum and chest infections.
Under terms of the agreement, Forest will make an upfront payment of $60
million to Almirall and will pay future undisclosed milestone payments. In
addition, Almirall will receive royalty payments based on LAS34273 sales.
Forest and Almirall will jointly oversee the development and regulatory
approval of LAS34273 and share all expenses for current and future development
programs. Almirall has granted Forest the rights of first negotiation for
other Almirall respiratory products that could be combined with LAS34273.
Forest will be responsible for sales and marketing of LAS34273 in the US
and Almirall has retained an option to co-promote the product in the future
while retaining commercialization rights for the rest of the world. In
addition to five years of Hatch-Waxman exclusivity granted upon approval,
LAS34273 is protected by an issued US composition of matter patent expiring in
2020. Extension of exclusivity under Hatch-Waxman legislation is expected.
Howard Solomon, Chairman and Chief Executive Officer of Forest commented:
"We are very pleased to be entering into this partnership with Almirall, which
is the largest and a highly successful independent pharmaceutical company in
Spain. We expect LAS34273 to become an important product in the treatment of
COPD, a major respiratory disease that affects over 12 million people in the
United States and is the nation's fourth leading cause of death. We have been
very impressed by the clinical profile of the drug based on the Phase II study
results as well as its convenient inhalation delivery system. LAS34273 is
another later stage product that augments our growing pipeline and validates
again our unique position and our business strategies."
"We are very pleased to be working with Forest to launch LAS34273 into the
fast growing COPD market", said Dr. Jorge Gallardo, Chairman and Chief
Executive Officer of Almirall. "Through this agreement we will collaborate
with a strong and experienced partner who has a successful track record in
building successful brands in the United States. We are confident that this
will be a successful partnership leveraging Forest's proven skills in clinical
development and marketing in the competitive US market. Both companies
believe LAS34273 is a compelling product that has promising potential to
become a leading treatment for patients suffering from COPD."
(1) American Lung Association
About Forest Laboratories
Forest Laboratories (http://www.frx.com ) is a US-based pharmaceutical
company dedicated to identifying, developing, and delivering products that
make a positive difference in peoples' lives. Forest Laboratories' growing
product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major depressive disorder
and for generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl-
D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate
to severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an
angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan medoxomil-
hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination
product, each indicated for the treatment of hypertension; and Campral(R)*
(acamprosate calcium), indicated in combination with psychosocial support for
the maintenance of abstinence from alcohol in patients with alcohol dependence
who are abstinent at treatment initiation.
*Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is
a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA approvals, the
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in the Forest
Laboratories' SEC reports, including the Company's Annual Report on Form 10-K
for the fiscal year ended March 31, 2005, and on form 10-Q for the periods
ended June 30, September 30, 2005 and December 31, 2005.
About Almirall
Almirall is an international pharmaceutical company that researches,
develops and commercialises its own R&D and licensed specialties with the aim
of improving health and quality of life. Almirall research products include
AXERT9(R) (Almotriptan) for the treatment of migraine which was approved by
the FDA in 2001 and is marketed by Ortho-McNeil, a division of Johnson &
Johnson.
Almirall is to invest 750 million euros in R&D over the next five years.
Almirall, whose headquarters are in Barcelona (Spain), has a staff of over
3,200 people, approximately 500 of whom work in R&D and with approximately
1000 working internationally in Almirall affiliate companies.
The therapeutic areas on which Almirall focuses its research resources are
related to the treatment of COPD, asthma, psoriasis and rheumatoid arthritis.
Almirall is currently present in approximately 100 countries with its own
products and licensed products from other companies. The company is
strengthening its direct presence in Europe and Latin America via affiliates
in France, Germany, Italy, Portugal, Belgium and Mexico.
For more information: http://www.almirall.es
About COPD
COPD is the 4th leading cause of death in the U.S. and is projected to be
the 3rd leading cause of death for both men and women by 2020. In 2000 about
119.000 deaths in the US were due to COPD and in 2002 $18 billion direct cost
and 14 billion indirect costs were caused by COPD. Data from National Heart
Blood and lung Institute COPD fact sheet.
(www.nhlbi.nih.gov/health/public/lung/other/copd_fact.pdf)
SOURCE Forest Laboratories, Inc.; Almirall
-0- 04/10/2006
/CONTACT: Charles E. Triano, Vice President-Investor Relations, Forest
Laboratories, Inc., +1-212-224-6714, charles.triano@frx.com; Carla Cudos,
carla.cudos@ketchum.com or Victoria Hernandez, victoria.hernandez@ketchum.com,
both of Ketchum/SEIS, for Almirall, +34-91-788-32-00 /
/Photo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO /
/Web site: http://www.frx.com
http://www.almirall.es /
(FRX)
CO: Forest Laboratories, Inc.; Almirall
ST: New York, Spain
IN: BIO HEA MTC
SU:
AH
-- NYM016 --
6110 04/10/2006 08:00 EDT http://www.prnewswire.com
NEW YORK and BARCELONA, Spain, April 10 /PRNewswire-FirstCall/ -- Forest
Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories,
Inc. (NYSE: FRX) and Almirall, a privately held pharmaceutical company
headquartered in Barcelona, Spain, announced today that the two companies have
entered an agreement to develop, market and distribute Almirall's novel
inhaled, long-acting muscarinic antagonist, LAS34273, in the United States.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
The innovative LAS34273 is now entering Phase III studies in the United
States and Europe for chronic obstructive pulmonary disease (COPD). LAS34273
has been evaluated in Phase II studies that demonstrate that it has a fast
onset of action and provides 24 hours of bronchodilation. LAS 34273 is
designed to have a very specific action in the lungs resulting in a low level
of systemic exposure. Studies to date including cardiovascular safety studies
support a favorable side effects profile. The product is being developed in a
Multi Dose-Dry Powder Inhaler (MDPI) which represents an improvement in drug
delivery over currently available devices.
This new treatment promises to provide relief for the many sufferers of
COPD. According to the World Health Organisation, COPD is the 5th leading
cause of death worldwide and the fourth in the US. Affecting over 12 million
adults in the US, it is also estimated that a further 24 million show some
evidence of impaired lung function highlighting a clear under diagnoses of
COPD.(1) The condition, which is mainly caused by smoking, results in damage
to the airways which triggers symptoms such as cough, breathlessness, excess
sputum and chest infections.
Under terms of the agreement, Forest will make an upfront payment of $60
million to Almirall and will pay future undisclosed milestone payments. In
addition, Almirall will receive royalty payments based on LAS34273 sales.
Forest and Almirall will jointly oversee the development and regulatory
approval of LAS34273 and share all expenses for current and future development
programs. Almirall has granted Forest the rights of first negotiation for
other Almirall respiratory products that could be combined with LAS34273.
Forest will be responsible for sales and marketing of LAS34273 in the US
and Almirall has retained an option to co-promote the product in the future
while retaining commercialization rights for the rest of the world. In
addition to five years of Hatch-Waxman exclusivity granted upon approval,
LAS34273 is protected by an issued US composition of matter patent expiring in
2020. Extension of exclusivity under Hatch-Waxman legislation is expected.
Howard Solomon, Chairman and Chief Executive Officer of Forest commented:
"We are very pleased to be entering into this partnership with Almirall, which
is the largest and a highly successful independent pharmaceutical company in
Spain. We expect LAS34273 to become an important product in the treatment of
COPD, a major respiratory disease that affects over 12 million people in the
United States and is the nation's fourth leading cause of death. We have been
very impressed by the clinical profile of the drug based on the Phase II study
results as well as its convenient inhalation delivery system. LAS34273 is
another later stage product that augments our growing pipeline and validates
again our unique position and our business strategies."
"We are very pleased to be working with Forest to launch LAS34273 into the
fast growing COPD market", said Dr. Jorge Gallardo, Chairman and Chief
Executive Officer of Almirall. "Through this agreement we will collaborate
with a strong and experienced partner who has a successful track record in
building successful brands in the United States. We are confident that this
will be a successful partnership leveraging Forest's proven skills in clinical
development and marketing in the competitive US market. Both companies
believe LAS34273 is a compelling product that has promising potential to
become a leading treatment for patients suffering from COPD."
(1) American Lung Association
About Forest Laboratories
Forest Laboratories (http://www.frx.com ) is a US-based pharmaceutical
company dedicated to identifying, developing, and delivering products that
make a positive difference in peoples' lives. Forest Laboratories' growing
product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major depressive disorder
and for generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl-
D-aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate
to severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an
angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan medoxomil-
hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination
product, each indicated for the treatment of hypertension; and Campral(R)*
(acamprosate calcium), indicated in combination with psychosocial support for
the maintenance of abstinence from alcohol in patients with alcohol dependence
who are abstinent at treatment initiation.
*Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is
a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA approvals, the
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in the Forest
Laboratories' SEC reports, including the Company's Annual Report on Form 10-K
for the fiscal year ended March 31, 2005, and on form 10-Q for the periods
ended June 30, September 30, 2005 and December 31, 2005.
About Almirall
Almirall is an international pharmaceutical company that researches,
develops and commercialises its own R&D and licensed specialties with the aim
of improving health and quality of life. Almirall research products include
AXERT9(R) (Almotriptan) for the treatment of migraine which was approved by
the FDA in 2001 and is marketed by Ortho-McNeil, a division of Johnson &
Johnson.
Almirall is to invest 750 million euros in R&D over the next five years.
Almirall, whose headquarters are in Barcelona (Spain), has a staff of over
3,200 people, approximately 500 of whom work in R&D and with approximately
1000 working internationally in Almirall affiliate companies.
The therapeutic areas on which Almirall focuses its research resources are
related to the treatment of COPD, asthma, psoriasis and rheumatoid arthritis.
Almirall is currently present in approximately 100 countries with its own
products and licensed products from other companies. The company is
strengthening its direct presence in Europe and Latin America via affiliates
in France, Germany, Italy, Portugal, Belgium and Mexico.
For more information: http://www.almirall.es
About COPD
COPD is the 4th leading cause of death in the U.S. and is projected to be
the 3rd leading cause of death for both men and women by 2020. In 2000 about
119.000 deaths in the US were due to COPD and in 2002 $18 billion direct cost
and 14 billion indirect costs were caused by COPD. Data from National Heart
Blood and lung Institute COPD fact sheet.
(www.nhlbi.nih.gov/health/public/lung/other/copd_fact.pdf)
SOURCE Forest Laboratories, Inc.; Almirall
-0- 04/10/2006
/CONTACT: Charles E. Triano, Vice President-Investor Relations, Forest
Laboratories, Inc., +1-212-224-6714, charles.triano@frx.com; Carla Cudos,
carla.cudos@ketchum.com or Victoria Hernandez, victoria.hernandez@ketchum.com,
both of Ketchum/SEIS, for Almirall, +34-91-788-32-00 /
/Photo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO /
/Web site: http://www.frx.com
http://www.almirall.es /
(FRX)
CO: Forest Laboratories, Inc.; Almirall
ST: New York, Spain
IN: BIO HEA MTC
SU:
AH
-- NYM016 --
6110 04/10/2006 08:00 EDT http://www.prnewswire.com
Antwort auf Beitrag Nr.: 21.156.325 von grigri4 am 11.04.06 10:51:55Kurzfristig stellen diese Vereinbarungen eine Belastung für den Gewinn dar, langfristig sind sie der Treibstoff für das Unternehmen.
Mir gefällt die Strategie ausgesprochen gut.
Mir gefällt die Strategie ausgesprochen gut.
Egal was das Management von Forest Labs auch sagt, verlieren sie den Rechtsstreit mit TEVA, dann geht es erst mal bergab. Der Lexapro Umstz macht über 60% des Gesamtumsatzes aus. Nicht auszudeneken was passieren wird, wenn das Gericht Generika zulassen würde. Ich bin zwar nach wie vor investiert, aber nur noch mit einer vergleichsweise kleinen Position, das Risiko ist mir z.Z. doch zu groß.
Es folgt eine Meldung zu den neuesten Zahlen.
Gruß Balou
-----
Forest Laboratories (FRX:NYSE - commentary - research - Cramer's Take) posted higher fourth-quarter profit and sales than it had a year ago, but the New York-based drug company's shares were under pressure following the report.
Forest earned $91.9 million, or 28 cents a share, on revenue of $756.3 million for the three months ended March 31. For the same period last year, Forest earned $52.8 million, or 15 cents a share, with revenue of $618.3 million.
However, the stock lost $2.19, or 5.1%, to $41.12 by early afternoon, having fallen as low as $40.70.
"Overall, the quarter was disappointing," says analyst Gary Nachman of Leerink Swann. He maintained his market-perform rating in a research note issued after the quarterly results.
Sales of the antidepressant Lexapro were slightly below his estimate, and the earnings per share was 9 cents short of his prediction. He doesn't own shares, and his firm doesn't have an investment-banking relationship with Forest.
Nachman and other analysts focused their attention on Lexapro, which provided $464.1 million in sales for the fourth quarter, a 16% increase from the same period last year. Lexapro is Forest's biggest product.
Forest licenses the drug from Denmark's H. Lundbeck, and they are suing the former Ivax, now owned by Teva Pharmaceutical Industries (TEVA:Nasdaq ADR - commentary - research - Cramer's Take), for patent infringement. The U.S. trial was held in March, and Forest executives told analysts Tuesday they expect a decision in June or July.
Although Lexapro's sales were affected by discounts and inventory fluctuations, Nachman says "a number of clouds" hang over the drug, including the patent suit and generic competition.
Analysts are tracking how generic versions of Forest's Celexa, the older cousin of Lexapro, and of Pfizer's (PFE:NYSE - commentary - research - Cramer's Take) Zoloft will affect Lexapro, as managed care companies try to steer patients to cheaper generics. Zoloft loses U.S. patent protection in late June.
-----
Es folgt eine Meldung zu den neuesten Zahlen.
Gruß Balou
-----
Forest Laboratories (FRX:NYSE - commentary - research - Cramer's Take) posted higher fourth-quarter profit and sales than it had a year ago, but the New York-based drug company's shares were under pressure following the report.
Forest earned $91.9 million, or 28 cents a share, on revenue of $756.3 million for the three months ended March 31. For the same period last year, Forest earned $52.8 million, or 15 cents a share, with revenue of $618.3 million.
However, the stock lost $2.19, or 5.1%, to $41.12 by early afternoon, having fallen as low as $40.70.
"Overall, the quarter was disappointing," says analyst Gary Nachman of Leerink Swann. He maintained his market-perform rating in a research note issued after the quarterly results.
Sales of the antidepressant Lexapro were slightly below his estimate, and the earnings per share was 9 cents short of his prediction. He doesn't own shares, and his firm doesn't have an investment-banking relationship with Forest.
Nachman and other analysts focused their attention on Lexapro, which provided $464.1 million in sales for the fourth quarter, a 16% increase from the same period last year. Lexapro is Forest's biggest product.
Forest licenses the drug from Denmark's H. Lundbeck, and they are suing the former Ivax, now owned by Teva Pharmaceutical Industries (TEVA:Nasdaq ADR - commentary - research - Cramer's Take), for patent infringement. The U.S. trial was held in March, and Forest executives told analysts Tuesday they expect a decision in June or July.
Although Lexapro's sales were affected by discounts and inventory fluctuations, Nachman says "a number of clouds" hang over the drug, including the patent suit and generic competition.
Analysts are tracking how generic versions of Forest's Celexa, the older cousin of Lexapro, and of Pfizer's (PFE:NYSE - commentary - research - Cramer's Take) Zoloft will affect Lexapro, as managed care companies try to steer patients to cheaper generics. Zoloft loses U.S. patent protection in late June.
-----
Antwort auf Beitrag Nr.: 21.321.850 von Balou2 am 25.04.06 23:32:14Nachdem Forest die letzten 2 Jahre etw. 55 Millionen Aktien zurückgekauft hat haben sie nun weil das letzte Programm inzwischen abgeschlossen ist ein neues über weitere 25 Millionen Aktien aufgelegt, das sofort in Kraft tritt. Wird das Programm noch in diesem Jahr abgeschlossen hätte die Firma innerhalb von 2,5 Jahren etw. 20% der ausstehenden Aktien zurückgekauft. Bei Abschluss dürften nur noch etwas mehr als 300 Millionen Aktien in Umlauf sein. Das Management nutzt die historisch sehr niedrigen Kurse und die komfortable Mittelausstattung durchaus weise. Mit dem nächsten umsatzstarken Präparat sollte das deutlich spürbar werden.
Gruß grigri
Forest Laboratories, Inc. has added a news release to its Investor Relations website.
Title: Forest Laboratories, Inc. Announces New Share Repurchase Program
Date: 5/18/2006 2:25:00 PM
For a complete listing of our news releases, please click here
NEW YORK, May 18 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today that its Board of Directors has approved a new
share repurchase program for up to an additional 25 million shares of its
common stock. The authorization will become effective immediately and has no
set expiration date. The Company expects to make the repurchases from time to
time in the open market depending on market conditions.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
The new program is in addition to two previously announced and completed
share repurchase programs: a 20 million share repurchase program announced on
July 20, 2004 and expanded to 30 million shares on December 14, 2004 as well
as a 25 million share repurchase program announced May 10, 2006.
About Forest Laboratories
Forest Laboratories (http://www.frx.com) is a US-based pharmaceutical
company dedicated to identifying, developing and delivering products that make
a positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults
for the initial and maintenance treatment of major depressive disorder and for
generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl-D-
aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate
to severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an
angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan medoxomil-
hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination
product, each indicated for the treatment of hypertension; and Campral(R)*
(acamprosate calcium), indicated in combination with psychosocial support for
the maintenance of abstinence from alcohol in patients with alcohol dependence
who are abstinent at treatment initiation.
*Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is
a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA approvals, the
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in the Forest
Laboratories' SEC reports, including the Company's Annual Report on Form 10-K
for the fiscal year ended March 31, 2005, and on form 10-Q for the periods
ended June 30 ,2005, September 30, 2005 and December 31, 2005.
SOURCE Forest Laboratories, Inc.
-0- 05/18/2006
/CONTACT: Charles E. Triano, Vice President - Investor Relations,
+1-212-224-6714, Charles.Triano@frx.com/
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
PRN Photo Desk, photodesk@prnewswire.com/
/Web site: http://www.frx.com /
(FRX)
CO: Forest Laboratories, Inc.
ST: New York
IN: MTC HEA
SU:
EA
-- NYTH115 --
1989 05/18/2006 14:25 EDT http://www.prnewswire.com
If you are unable to click on the link above, please copy and paste the URL below into a web browser
http://www.frx.com/news/PressReleaseArchive.aspx
Gruß grigri
Forest Laboratories, Inc. has added a news release to its Investor Relations website.
Title: Forest Laboratories, Inc. Announces New Share Repurchase Program
Date: 5/18/2006 2:25:00 PM
For a complete listing of our news releases, please click here
NEW YORK, May 18 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) announced today that its Board of Directors has approved a new
share repurchase program for up to an additional 25 million shares of its
common stock. The authorization will become effective immediately and has no
set expiration date. The Company expects to make the repurchases from time to
time in the open market depending on market conditions.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
The new program is in addition to two previously announced and completed
share repurchase programs: a 20 million share repurchase program announced on
July 20, 2004 and expanded to 30 million shares on December 14, 2004 as well
as a 25 million share repurchase program announced May 10, 2006.
About Forest Laboratories
Forest Laboratories (http://www.frx.com) is a US-based pharmaceutical
company dedicated to identifying, developing and delivering products that make
a positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults
for the initial and maintenance treatment of major depressive disorder and for
generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl-D-
aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate
to severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an
angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan medoxomil-
hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination
product, each indicated for the treatment of hypertension; and Campral(R)*
(acamprosate calcium), indicated in combination with psychosocial support for
the maintenance of abstinence from alcohol in patients with alcohol dependence
who are abstinent at treatment initiation.
*Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral is
a registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA approvals, the
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in the Forest
Laboratories' SEC reports, including the Company's Annual Report on Form 10-K
for the fiscal year ended March 31, 2005, and on form 10-Q for the periods
ended June 30 ,2005, September 30, 2005 and December 31, 2005.
SOURCE Forest Laboratories, Inc.
-0- 05/18/2006
/CONTACT: Charles E. Triano, Vice President - Investor Relations,
+1-212-224-6714, Charles.Triano@frx.com/
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
PRN Photo Desk, photodesk@prnewswire.com/
/Web site: http://www.frx.com /
(FRX)
CO: Forest Laboratories, Inc.
ST: New York
IN: MTC HEA
SU:
EA
-- NYTH115 --
1989 05/18/2006 14:25 EDT http://www.prnewswire.com
If you are unable to click on the link above, please copy and paste the URL below into a web browser
http://www.frx.com/news/PressReleaseArchive.aspx
Das nenne ich eine gute Nachricht.
Forest Announces Federal Court Upholds Lexapro(R) Patent
NEW YORK, July 13 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) said today that the U.S. District Court for the District of Delaware has determined that the U.S. patent covering escitalopram, the active ingredient in Lexapro(R), is both valid, enforceable and infringed by Ivax/Teva's proposed generic product, thereby confirming Forest's and Lundbeck's patent rights for Lexapro(R), which expire in March 2012.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Judge Joseph J. Farnan ruled in Forest's and Lundbeck's favor in a lawsuit brought by Forest and its partner H. Lundbeck A/S of Denmark against the generic manufacturer Ivax/Teva.
The patent at issue in the U.S. lawsuit is Lexapro's patent (U.S. Patent No. Re 34,712), which is set to expire in March 2012 and covers substantially pure escitalopram.
http://www.frx.com/news/PressRelease.aspx?ID=882051
Forest Announces Federal Court Upholds Lexapro(R) Patent
NEW YORK, July 13 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) said today that the U.S. District Court for the District of Delaware has determined that the U.S. patent covering escitalopram, the active ingredient in Lexapro(R), is both valid, enforceable and infringed by Ivax/Teva's proposed generic product, thereby confirming Forest's and Lundbeck's patent rights for Lexapro(R), which expire in March 2012.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Judge Joseph J. Farnan ruled in Forest's and Lundbeck's favor in a lawsuit brought by Forest and its partner H. Lundbeck A/S of Denmark against the generic manufacturer Ivax/Teva.
The patent at issue in the U.S. lawsuit is Lexapro's patent (U.S. Patent No. Re 34,712), which is set to expire in March 2012 and covers substantially pure escitalopram.
http://www.frx.com/news/PressRelease.aspx?ID=882051
Antwort auf Beitrag Nr.: 22.583.486 von betterthantherest am 14.07.06 09:01:22Forest Laboratories, Inc. has added a news release to its Investor Relations website.
Title: Forest Laboratories Reports Earnings Per Share of $0.75 for Q2'07
Date: 10/17/2006 7:57:00 AM
For a complete listing of our news releases, please click here
Updates Fiscal 2007 Guidance
NEW YORK, Oct. 17 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX), an international pharmaceutical manufacturer and marketer, today
announced that fully diluted earnings per share equaled $0.75 in the second
quarter of fiscal 2007, an increase of 27% over last year's second quarter's
fully diluted earnings per share of $0.59. Reported earnings included a $9.1
million charge for stock option expense in accordance with the adoption of
Statement of Financial Accounting Standard 123R.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Net revenues for the quarter increased 15% to $846,975,000 from
$736,472,000 in the year-ago period.
Net revenues were comprised of net sales, which increased 13% to
$778,676,000 from $691,633,000 in the prior year. Sales in the quarter
included $522,662,000 for Lexapro(R) (escitalopram oxalate), our SSRI for the
treatment of depression and anxiety in adults, an increase of 12% from the
year-ago period. Namenda(R), our NMDA receptor antagonist for the treatment of
moderate and severe Alzheimer's disease, recorded sales of $155,586,000 during
the quarter, growth of 26% from last year. Also included in net revenues was
other income of $68,299,000 which includes $48,315,000 in earnings
contribution from the Benicar(R)* (olmesartan medoxomil) co-promotion
agreement, an increase of 55%. The remaining component of other income was
principally interest income.
Net income in the current quarter increased 18% to $241,111,000 from
$204,884,000 reported in the second quarter of the prior year. Selling,
general and administrative expenses increased 2% to $259,008,000. Research and
development expenses increased 43% to $93,752,000 during the quarter.
Fully diluted shares outstanding at September 30, 2006 were 322,581,000 a
reduction of 23 million shares compared to the year-ago period due mainly to
the Company's ongoing share repurchase program. During the just-completed
quarter, the Company repurchased approximately 7.2 million shares leaving an
additional 16 million shares available for repurchase under the existing
program, which has no expiration date.
Six Month Results
Revenues for the six months ended September 30, 2006 increased 15% to
$1,663,313,000 from $1,448,238,000 in the prior year.
Net income for the six months ended September 30, 2006 increased 5% to
$441,718,000 from net income of $421,461,000 reported in the six months of the
prior year. Diluted earnings per share increased 12% to $1.36 in the current
year's first six months as compared to diluted earnings per share of $1.21 in
last year's six months. The year-ago six-month earnings per share reflect a
one-time tax benefit of $36.4 million, or $0.10 per share, related to the
repatriation of foreign funds under the American Jobs Creation Act of 2004.
Excluding the one-time tax benefit, year-ago fully diluted earnings per share
were $1.11.
Fiscal 2007 Guidance
Based on the stronger-than-projected performance of our promoted products,
accretion from shares repurchased fiscal year-to-date, and shifting
approximately $43 million in planned product milestone payments into next
fiscal year, the Company has increased its expectations for fully diluted
earning per share for the fiscal year ending March 31, 2007 to $2.60-$2.65
>from prior guidance of $2.45-$2.50 per share. The earnings per share guidance
does not include the potential impact from additional share repurchases which
may be made under the Company's remaining authorization of 16 million shares.
Howard Solomon, Chairman and Chief Executive Officer of Forest, commented:
"We are very pleased with the continued strong performance of our key marketed
products: Lexapro, Namenda and Benicar. Given this performance as well as
accretion from our significant share repurchases, Forest is now projecting a
level of annual earnings per share that meaningfully exceeds our prior record
level achieved in fiscal 2005, the last year of Celexa's exclusivity. At the
same time the Company is also significantly increasing its investment in
research and development.
This investment will support the continued development of current pipeline
products as well as allow the Company to continue to expand the product
pipeline. The ultimate goal and key focus of the Company is to successfully
license, develop and commercialize a next generation of Forest products that
will ultimately more than replace profits from today's key products which lose
exclusivity in the early part of the next decade."
Forest will host a conference call at 10:00 AM EDT today to discuss the
results. The conference call will be webcast live beginning at 10:00 AM EDT on
the Company's website at www.frx.com and also on the website
www.streetevents.com. Please log on to either website at least fifteen minutes
prior to the conference call as it may be necessary to download software to
access the call. A replay of the conference call will be available until
October 31, 2006 at both websites and also by dialing 1-800-642-1687 (US
investors) or +1-706-645-9291 (international investors) passcode 8085488.
About Forest Laboratories and Its Products
Forest Laboratories (www.frx.com) is a US-based pharmaceutical company
dedicated to identifying, developing, and delivering products that make a
positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults
for the initial and maintenance treatment of major depressive disorder and for
generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl-D-
aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate
and severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an
angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan medoxomil-
hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination
product, each indicated for the treatment of hypertension; and Campral(R)*
(acamprosate calcium), indicated in combination with psychosocial support for
the maintenance of abstinence from alcohol in patients with alcohol dependence
who are abstinent at treatment initiation.
* Benicar is a registered trademark of Daiichi Sankyo, and Campral is a
registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA approvals,
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products and the risk factors listed from time to time in the Company's SEC
reports, including the Company's Annual Report on Form 10-K for the fiscal
year ended March 31, 2006 and on Form 10-Q for the period ended June 30, 2006.
FOREST LABORATORIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(Unaudited)
THREE MONTHS SIX MONTHS
ENDED SEPTEMBER 30 ENDED SEPTEMBER 30
(In thousands, except per share amounts)
2006 2005 2006 2005
Revenues:
Net sales $778,676 $691,633 $1,537,444 $1,366,286
Contract revenue 48,909 32,303 91,571 58,572
Other income 19,390 12,536 34,298 23,380
Net revenues 846,975 736,472 1,663,313 1,448,238
Costs and expenses:
Cost of goods sold 185,098 158,415 360,783 317,261
Selling, general and
administrative 259,008 253,237 503,391 521,710
Research and
development 93,752 65,473 232,834 121,866
537,858 477,125 1,097,008 960,837
Income before income
tax expense 309,117 259,347 566,305 487,401
Income tax expense 68,006 54,463 124,587 65,940
Net income $241,111 $204,884 $441,718 $421,461
Net income per share:
Basic $0.76 $0.60 $1.38 $1.23
Diluted $0.75 $0.59 $1.36 $1.21
Weighted average number of
shares outstanding:
Basic 317,809 340,531 319,623 341,808
Diluted 322,581 345,815 324,256 346,883
SOURCE Forest Laboratories, Inc.
-0- 10/17/2006
/CONTACT: Charles E. Triano, Vice President - Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714, charles.triano@frx.com /
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com/
/Web site: http://www.frx.com/
(FRX)
CO: Forest Laboratories, Inc.
ST: New York
IN: HEA MTC BIO
SU: ERN ERP CCA
Title: Forest Laboratories Reports Earnings Per Share of $0.75 for Q2'07
Date: 10/17/2006 7:57:00 AM
For a complete listing of our news releases, please click here
Updates Fiscal 2007 Guidance
NEW YORK, Oct. 17 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX), an international pharmaceutical manufacturer and marketer, today
announced that fully diluted earnings per share equaled $0.75 in the second
quarter of fiscal 2007, an increase of 27% over last year's second quarter's
fully diluted earnings per share of $0.59. Reported earnings included a $9.1
million charge for stock option expense in accordance with the adoption of
Statement of Financial Accounting Standard 123R.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Net revenues for the quarter increased 15% to $846,975,000 from
$736,472,000 in the year-ago period.
Net revenues were comprised of net sales, which increased 13% to
$778,676,000 from $691,633,000 in the prior year. Sales in the quarter
included $522,662,000 for Lexapro(R) (escitalopram oxalate), our SSRI for the
treatment of depression and anxiety in adults, an increase of 12% from the
year-ago period. Namenda(R), our NMDA receptor antagonist for the treatment of
moderate and severe Alzheimer's disease, recorded sales of $155,586,000 during
the quarter, growth of 26% from last year. Also included in net revenues was
other income of $68,299,000 which includes $48,315,000 in earnings
contribution from the Benicar(R)* (olmesartan medoxomil) co-promotion
agreement, an increase of 55%. The remaining component of other income was
principally interest income.
Net income in the current quarter increased 18% to $241,111,000 from
$204,884,000 reported in the second quarter of the prior year. Selling,
general and administrative expenses increased 2% to $259,008,000. Research and
development expenses increased 43% to $93,752,000 during the quarter.
Fully diluted shares outstanding at September 30, 2006 were 322,581,000 a
reduction of 23 million shares compared to the year-ago period due mainly to
the Company's ongoing share repurchase program. During the just-completed
quarter, the Company repurchased approximately 7.2 million shares leaving an
additional 16 million shares available for repurchase under the existing
program, which has no expiration date.
Six Month Results
Revenues for the six months ended September 30, 2006 increased 15% to
$1,663,313,000 from $1,448,238,000 in the prior year.
Net income for the six months ended September 30, 2006 increased 5% to
$441,718,000 from net income of $421,461,000 reported in the six months of the
prior year. Diluted earnings per share increased 12% to $1.36 in the current
year's first six months as compared to diluted earnings per share of $1.21 in
last year's six months. The year-ago six-month earnings per share reflect a
one-time tax benefit of $36.4 million, or $0.10 per share, related to the
repatriation of foreign funds under the American Jobs Creation Act of 2004.
Excluding the one-time tax benefit, year-ago fully diluted earnings per share
were $1.11.
Fiscal 2007 Guidance
Based on the stronger-than-projected performance of our promoted products,
accretion from shares repurchased fiscal year-to-date, and shifting
approximately $43 million in planned product milestone payments into next
fiscal year, the Company has increased its expectations for fully diluted
earning per share for the fiscal year ending March 31, 2007 to $2.60-$2.65
>from prior guidance of $2.45-$2.50 per share. The earnings per share guidance
does not include the potential impact from additional share repurchases which
may be made under the Company's remaining authorization of 16 million shares.
Howard Solomon, Chairman and Chief Executive Officer of Forest, commented:
"We are very pleased with the continued strong performance of our key marketed
products: Lexapro, Namenda and Benicar. Given this performance as well as
accretion from our significant share repurchases, Forest is now projecting a
level of annual earnings per share that meaningfully exceeds our prior record
level achieved in fiscal 2005, the last year of Celexa's exclusivity. At the
same time the Company is also significantly increasing its investment in
research and development.
This investment will support the continued development of current pipeline
products as well as allow the Company to continue to expand the product
pipeline. The ultimate goal and key focus of the Company is to successfully
license, develop and commercialize a next generation of Forest products that
will ultimately more than replace profits from today's key products which lose
exclusivity in the early part of the next decade."
Forest will host a conference call at 10:00 AM EDT today to discuss the
results. The conference call will be webcast live beginning at 10:00 AM EDT on
the Company's website at www.frx.com and also on the website
www.streetevents.com. Please log on to either website at least fifteen minutes
prior to the conference call as it may be necessary to download software to
access the call. A replay of the conference call will be available until
October 31, 2006 at both websites and also by dialing 1-800-642-1687 (US
investors) or +1-706-645-9291 (international investors) passcode 8085488.
About Forest Laboratories and Its Products
Forest Laboratories (www.frx.com) is a US-based pharmaceutical company
dedicated to identifying, developing, and delivering products that make a
positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults
for the initial and maintenance treatment of major depressive disorder and for
generalized anxiety disorder; Namenda(R) (memantine HCl), an N-methyl-D-
aspartate (NMDA)-receptor antagonist indicated for the treatment of moderate
and severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an
angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan medoxomil-
hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination
product, each indicated for the treatment of hypertension; and Campral(R)*
(acamprosate calcium), indicated in combination with psychosocial support for
the maintenance of abstinence from alcohol in patients with alcohol dependence
who are abstinent at treatment initiation.
* Benicar is a registered trademark of Daiichi Sankyo, and Campral is a
registered trademark of Merck Sante s.a.s., subsidiary of Merck KGaA,
Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA approvals,
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products and the risk factors listed from time to time in the Company's SEC
reports, including the Company's Annual Report on Form 10-K for the fiscal
year ended March 31, 2006 and on Form 10-Q for the period ended June 30, 2006.
FOREST LABORATORIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(Unaudited)
THREE MONTHS SIX MONTHS
ENDED SEPTEMBER 30 ENDED SEPTEMBER 30
(In thousands, except per share amounts)
2006 2005 2006 2005
Revenues:
Net sales $778,676 $691,633 $1,537,444 $1,366,286
Contract revenue 48,909 32,303 91,571 58,572
Other income 19,390 12,536 34,298 23,380
Net revenues 846,975 736,472 1,663,313 1,448,238
Costs and expenses:
Cost of goods sold 185,098 158,415 360,783 317,261
Selling, general and
administrative 259,008 253,237 503,391 521,710
Research and
development 93,752 65,473 232,834 121,866
537,858 477,125 1,097,008 960,837
Income before income
tax expense 309,117 259,347 566,305 487,401
Income tax expense 68,006 54,463 124,587 65,940
Net income $241,111 $204,884 $441,718 $421,461
Net income per share:
Basic $0.76 $0.60 $1.38 $1.23
Diluted $0.75 $0.59 $1.36 $1.21
Weighted average number of
shares outstanding:
Basic 317,809 340,531 319,623 341,808
Diluted 322,581 345,815 324,256 346,883
SOURCE Forest Laboratories, Inc.
-0- 10/17/2006
/CONTACT: Charles E. Triano, Vice President - Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714, charles.triano@frx.com /
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com/
/Web site: http://www.frx.com/
(FRX)
CO: Forest Laboratories, Inc.
ST: New York
IN: HEA MTC BIO
SU: ERN ERP CCA
Hier ist der Grund, warum FRX heute recht kräftig unter die Räder gekommen ist. Nachdem sich der Kurs zuletzt nach dem gewonnen Patentverfahren sehr gut erholt hat, gab es heute einen Dämpfer dadurch, dass das Antibiotikum faropenem medoxomil von der FDA (noch ?) nicht zugelaasen worden ist.
Beide Partner streben aber an, den Genehmigungsprozess weiter zu gehen.
Gruß
Balou
-----
BOSTON (MarketWatch) -- Shares of Forest Laboratories and partner Replidyne Inc. were hit hard Monday by news that the Food and Drug Administration has given the thumbs down for their antibiotic candidate faropenem medoxomil.
Early Monday, Forest and Replidyne announced that the FDA had issued a non-approvable letter for their marketing application for faropenem, stating it would not approve the antibiotic unless more clinical trials were conducted.
Replidyne had submitted its market application in December 2005, asking the FDA to approve the antibiotic for the treatment of four conditions: acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin structure infections.
Replidyne said the FDA is now recommending more clinical trials for all of the conditions. However, the agency did not indicate it was concerned about the safety or production of the drug, two other key elements of the drug approval process.
"Replidyne and Forest intend to discuss the clinical plans with the FDA including the number of trials needed for each indication, and expect that a minimum of two years will be required for completion of the clinical studies," the companies said in a joint statement.
Forest entered into a collaboration with Replidyne in February 2006 to commercialize the drug. The antibiotic is Replidyne's lead drug candidate. Forest is best known for its popular antidepressant Lexapro.
Replidyne added that it was in a strong enough financial position to bring the drug through the approval stage. Forest, meanwhile, said it intends to persevere in getting the drug approved for at least two respiratory indications.
Prudential analyst Tim Anderson maintained his neutral weight rating on Forest following the news, stating the move shouldn't have a "huge" earnings impact on the specialty drugmaker for at least the next two years. He noted, however, that it is yet another drug candidate in its late-stage pipeline that has been hit with a regulatory setback.
-----
Beide Partner streben aber an, den Genehmigungsprozess weiter zu gehen.
Gruß
Balou
-----
BOSTON (MarketWatch) -- Shares of Forest Laboratories and partner Replidyne Inc. were hit hard Monday by news that the Food and Drug Administration has given the thumbs down for their antibiotic candidate faropenem medoxomil.
Early Monday, Forest and Replidyne announced that the FDA had issued a non-approvable letter for their marketing application for faropenem, stating it would not approve the antibiotic unless more clinical trials were conducted.
Replidyne had submitted its market application in December 2005, asking the FDA to approve the antibiotic for the treatment of four conditions: acute bacterial sinusitis, community-acquired pneumonia, acute exacerbation of chronic bronchitis and uncomplicated skin and skin structure infections.
Replidyne said the FDA is now recommending more clinical trials for all of the conditions. However, the agency did not indicate it was concerned about the safety or production of the drug, two other key elements of the drug approval process.
"Replidyne and Forest intend to discuss the clinical plans with the FDA including the number of trials needed for each indication, and expect that a minimum of two years will be required for completion of the clinical studies," the companies said in a joint statement.
Forest entered into a collaboration with Replidyne in February 2006 to commercialize the drug. The antibiotic is Replidyne's lead drug candidate. Forest is best known for its popular antidepressant Lexapro.
Replidyne added that it was in a strong enough financial position to bring the drug through the approval stage. Forest, meanwhile, said it intends to persevere in getting the drug approved for at least two respiratory indications.
Prudential analyst Tim Anderson maintained his neutral weight rating on Forest following the news, stating the move shouldn't have a "huge" earnings impact on the specialty drugmaker for at least the next two years. He noted, however, that it is yet another drug candidate in its late-stage pipeline that has been hit with a regulatory setback.
-----
Guten Tag,
was vertreibt denn dieses Unternehmen? Kann mir jemand darüber eine Auskunft geben?
was vertreibt denn dieses Unternehmen? Kann mir jemand darüber eine Auskunft geben?
Antwort auf Beitrag Nr.: 25.619.521 von HansiDurchblick am 23.11.06 12:57:25http://finance.yahoo.com/q/pr?s=FRX
Antwort auf Beitrag Nr.: 25.619.521 von HansiDurchblick am 23.11.06 12:57:25Ist eine kleine bis mittelgroße Pharma-Firma. Hauptmedikament war mal ein Psychopharmakum. Aber sicher viel mehr Details auf deren Webseite.
@ Hansidurchblick
da wäre zunächst Lexapro ein Präparat zur Behandlung von Depressionen und Angstzuständen mit einem Anteil von ca. 67% am Gesamtumsatz. An zweiter Stelle liegt Namenda (ein Alzheimer Medikament) mit knapp 20% Umsatzanteil. Die beiden haben im letzten Quartal 12% bzw. 26% zugelegt. Darüber hinaus gibt es noch ein paar weitere Medikamente, die jedoch (noch ?) nicht die Bedeutung haben, wie die beiden vorgenanten.
Zu erwähnen vielleicht noch Benicar (Bluthochdruck) und Campral, ein Medikament gegen Alkoholabhängigkeit.
Ein wenig Obacht muss man auf die aktuelle Pipeline haben. Die Umsätze mit den vorhandenen Medikamenten lassen sich nicht unnendlich steigern und so ein richtiger zukünftiger Blockbuster ist derzeit nicht zu erkennen.
Allerdings kommen auch immer wieder mal Gerüchte auf, dass FRX als Übernahmekandiat interessant sein könnte.
FRX hat allerdings eine sehr gute Ausstattung mit Eigenkapital vorzuweisen. Das Geschäftsmodell basiert im wesentlichen darauf andere kleinere Firmen die Grundlagenforschung und Entwicklung betreiben zu lassen und erst im späteren Stadium (z.B. Phase III) mit einzusteigen, wenn den Firmen das Geld ausgeht, um die klinischen Studien und Markteinführung selbst schultern zu können.
Dafür sichert man sich dann die Vertriebsrechte für Nordamerika. Derzeit gehört mit Paion auch ein deutsches Unternehmen zu denen, mit denen gemeinsam entwickelt wird.
Gruß
Balou
da wäre zunächst Lexapro ein Präparat zur Behandlung von Depressionen und Angstzuständen mit einem Anteil von ca. 67% am Gesamtumsatz. An zweiter Stelle liegt Namenda (ein Alzheimer Medikament) mit knapp 20% Umsatzanteil. Die beiden haben im letzten Quartal 12% bzw. 26% zugelegt. Darüber hinaus gibt es noch ein paar weitere Medikamente, die jedoch (noch ?) nicht die Bedeutung haben, wie die beiden vorgenanten.
Zu erwähnen vielleicht noch Benicar (Bluthochdruck) und Campral, ein Medikament gegen Alkoholabhängigkeit.
Ein wenig Obacht muss man auf die aktuelle Pipeline haben. Die Umsätze mit den vorhandenen Medikamenten lassen sich nicht unnendlich steigern und so ein richtiger zukünftiger Blockbuster ist derzeit nicht zu erkennen.
Allerdings kommen auch immer wieder mal Gerüchte auf, dass FRX als Übernahmekandiat interessant sein könnte.
FRX hat allerdings eine sehr gute Ausstattung mit Eigenkapital vorzuweisen. Das Geschäftsmodell basiert im wesentlichen darauf andere kleinere Firmen die Grundlagenforschung und Entwicklung betreiben zu lassen und erst im späteren Stadium (z.B. Phase III) mit einzusteigen, wenn den Firmen das Geld ausgeht, um die klinischen Studien und Markteinführung selbst schultern zu können.
Dafür sichert man sich dann die Vertriebsrechte für Nordamerika. Derzeit gehört mit Paion auch ein deutsches Unternehmen zu denen, mit denen gemeinsam entwickelt wird.
Gruß
Balou
Antwort auf Beitrag Nr.: 25.753.571 von Balou2 am 27.11.06 20:16:23Title: Forest Laboratories Announces Termination of Agreement for Faropenem
Date: 2/6/2007 5:30:00 PM
NEW YORK, Feb. 6 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) and Replidyne, Inc. announced today that they have terminated
their collaboration agreement for the development of faropenem medoxomil, a
novel oral, community antibiotic.
The agreement was announced in February 2006. In October 2006 the U.S.
Food and Drug Administration (FDA) issued a non-approvable letter for four
adult indications: acute bacterial sinusitis (ABS), community-acquired
pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB) and
uncomplicated skin and skin structure infections (SSSI). There are no
payments by Forest associated with the termination.
Howard Solomon, Chairman and Chief Executive Officer of Forest, stated:
"Forest believes the FDA's non-approvable letter clearly raises regulatory
uncertainty. We have carefully reviewed all the existing data and the FDA's
pronouncements and have determined that we should not continue further
development of the faropenem program."
About Forest Laboratories and Its Products
Forest Laboratories (http://www.frx.com ) is a US-based pharmaceutical
company dedicated to identifying, developing, and delivering products that
make a positive difference in peoples' lives. Forest Laboratories' growing
product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major depressive disorder
and for generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of
moderate to severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an
angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan
medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and diuretic
combination product, each indicated for the treatment of hypertension; and
Campral(R)* (acamprosate calcium), indicated in combination with psychosocial
support for the maintenance of abstinence from alcohol in patients with
alcohol dependence who are abstinent at treatment initiation.
<pre>
* Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral
is a registered trademark of Merck Sante s.a.s., subsidiary of Merck
KGaA, Darmstadt, Germany.
</pre>
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA approvals,
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products and the risk factors listed from time to time in the Companies' SEC
reports, including the Forest Laboratories, Inc.'s Annual Report on Form 10-K
for the fiscal year ended March 31, 2006 and on Form 10-Q for the periods
ended June 30, 2006 and September 30, 2006.
<pre>
SOURCE Forest Laboratories, Inc.
-0- 02/06/2007
/CONTACT: Charles E. Triano, Vice President - Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714, charles.triano@frx.com/
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com /
/Web site: http://www.frx.com /
(FRX)
CO: Forest Laboratories, Inc.; Replidyne, Inc.
ST: New York
IN: HEA MTC BIO
SU:
RM
-- NYTU191 --
1321 02/06/2007 17:30 EST http://www.prnewswire.com
</pre>
------------------------------------------------------------
If you are unable to click on the link above, please copy and paste the URL below into a web browser
http://www.frx.com/news/PressReleaseArchive.aspx
------------------------------------------------------------
Thomson Financial Inc 22 Thomson Place Boston, MA 02210
Click Here to unsubscribe from this JoinMail list.
Date: 2/6/2007 5:30:00 PM
NEW YORK, Feb. 6 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) and Replidyne, Inc. announced today that they have terminated
their collaboration agreement for the development of faropenem medoxomil, a
novel oral, community antibiotic.
The agreement was announced in February 2006. In October 2006 the U.S.
Food and Drug Administration (FDA) issued a non-approvable letter for four
adult indications: acute bacterial sinusitis (ABS), community-acquired
pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB) and
uncomplicated skin and skin structure infections (SSSI). There are no
payments by Forest associated with the termination.
Howard Solomon, Chairman and Chief Executive Officer of Forest, stated:
"Forest believes the FDA's non-approvable letter clearly raises regulatory
uncertainty. We have carefully reviewed all the existing data and the FDA's
pronouncements and have determined that we should not continue further
development of the faropenem program."
About Forest Laboratories and Its Products
Forest Laboratories (http://www.frx.com ) is a US-based pharmaceutical
company dedicated to identifying, developing, and delivering products that
make a positive difference in peoples' lives. Forest Laboratories' growing
product line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major depressive disorder
and for generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl-D-aspartate (NMDA)-receptor antagonist indicated for the treatment of
moderate to severe Alzheimer's disease; Benicar(R)* (olmesartan medoxomil), an
angiotensin receptor blocker, and Benicar* HCT(R) (olmesartan
medoxomil-hydrochlorothiazide), an angiotensin receptor blocker and diuretic
combination product, each indicated for the treatment of hypertension; and
Campral(R)* (acamprosate calcium), indicated in combination with psychosocial
support for the maintenance of abstinence from alcohol in patients with
alcohol dependence who are abstinent at treatment initiation.
<pre>
* Benicar is a registered trademark of Sankyo Pharma, Inc., and Campral
is a registered trademark of Merck Sante s.a.s., subsidiary of Merck
KGaA, Darmstadt, Germany.
</pre>
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Reform Act of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA approvals,
acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, the timely development and launch of new
products and the risk factors listed from time to time in the Companies' SEC
reports, including the Forest Laboratories, Inc.'s Annual Report on Form 10-K
for the fiscal year ended March 31, 2006 and on Form 10-Q for the periods
ended June 30, 2006 and September 30, 2006.
<pre>
SOURCE Forest Laboratories, Inc.
-0- 02/06/2007
/CONTACT: Charles E. Triano, Vice President - Investor Relations of
Forest Laboratories, Inc., +1-212-224-6714, charles.triano@frx.com/
/Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com /
/Web site: http://www.frx.com /
(FRX)
CO: Forest Laboratories, Inc.; Replidyne, Inc.
ST: New York
IN: HEA MTC BIO
SU:
RM
-- NYTU191 --
1321 02/06/2007 17:30 EST http://www.prnewswire.com
</pre>
------------------------------------------------------------
If you are unable to click on the link above, please copy and paste the URL below into a web browser
http://www.frx.com/news/PressReleaseArchive.aspx
------------------------------------------------------------
Thomson Financial Inc 22 Thomson Place Boston, MA 02210
Click Here to unsubscribe from this JoinMail list.
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