Deutsche Small Caps - Basisinvestments eines Langfristdepots (Seite 6876)
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Labopharm: Wenn die Raubtiere im Rudel ausschwärmen -
oder wie wird aus einem kurzfristigen Spiel ein mittelfristiges Investment!
Labopharm Just Became a Great Growth Stock
According to the Wednesday morning press release, the company expects to have OLEPTRO available for prescription in the United States later this year.
After spiking to nearly $3 on the market open, shares of DDSS traded down roughly to the $2.70 mark as the morning progressed, although volume was extremely heavy; the first hour of trading saw more than ten times the average daily volume change hands.
The modest bump in price did not meet the expectations of many investors, although it's my opinion that the February 3rd approval may have caught some off-guard since February 11th was expected to be the decision-day; and the FDA has been running behind schedule at that.
The booming volume would indicate that there are big players taking positions in the stock, and although OLEPTRO won't make it to market until later this year, the potential for a short term bump in price still exists since Wednesday's PR mentioned that the company "currently expects to finalize the commercialization plan for OLEPTRO[TM] in the near term."
That means partnership news can come at any time.
With an approved product in a very large market, DDSS should be considered a nice long term growth play, one that also could become a nice short to mid term story if the stock starts trading to its potential.
These days in the biotech sector it looks more and more like large investors like to see revenue before running the stock, but the small investor needs to have the patience to wait for the run.
Remember, the big boys will play their games and eat their cake, we're just trying to pick up a few crumbs along the way.
DDSS just became a great growth stock, in my opinion, especially since the share price hasn't changed on what should be considered big news.
Also worth mentioning is the possibility of dilution, although a partnership deal could bring enough of an upfront payment to LaboPharm to negate the need for raising a large sum of cash through stock sales.
UPDATE (after market close):
An early day price spike to nearly three dollars preceded the downturn that saw DDSS trade for as low as $2.17, before closing the day at $2.21. Volume remained very strong throughout the day, as expected after such news.
These days, it's not unusual to see such a drop in price after positive FDA approval news (see: BDSI, NRIFF.PK, etc); and although it's a bit nerve-shattering for longs of the stock to watch, it's actually nothing to complain about because it gives small investors the chance to buy shares of a company with an approved drug for the same price - or less - that just days before would have bought a more speculative company with an uncertain FDA decision looming.
Even when the stock trades down after positive news, it's still a better buy today than it was yesterday because of the increased certainty that the company will be able to generate revenue over the mid to long term.
However, it's because of scenarios like this one that demonstrate the need of the small investor to base investment decision on his or her own DD - and not the message boards, blogs or unexpected price swings; in the confusion it's a whole lot easier to sell into the uncertainty and move on, but an investor who is confident in the DD will have the fortitude to stick it out, maybe add some shares on the dip, and look towards the future.
The small investor cannot influence the stock price, the stock price will do what the big boys want it to do; it's up to the small investor to be on top of his or her game and to take advantage of the volatility and manipulation (if in fact manipulation is at play) . In this case it's a buying opportunity that has been presented, in my opinion.
When discussing possible manipulation, you can't ignore the fact that when the big boys want a stock to drop, they get their minions - that I like to call riff-raff - to swarm the message boards with multiple user IDs whose orders are to create a mood of confusion, panic, fear and uncertainty. Many small investors cannot handle the desperation that comes with all of those emotions and will therefore sell their shares (either for a loss or not as much profit as they could have banked by selling earlier) and play right into the hands of the riff-raff.
Once the stock has dropped and the riff-raff are somewhat satisfied with the amount of shares that they've shaken loose, they disappear off the message boards just as quickly as they showed up. Many will deny that such manipulation takes place, but after seeing the same game quite a few times, you'll feel a lot more comfortable holding through the storm, and possibly even adding a few shares.
Don't get me wrong, if something changes with the company that you're investing in that fits your 'exit strategy' protocol, then it may be wise to completely bail out. But if it's a secondary variable that is impacting the share price of your stock, and not actually events related to the company, then rely on your DD and stick to your entry/exit strategies.
It always comes back to DD and patience - and to not being afraid to take some profit off the table when the opportunity arises.
In the case of DDSS - as is usually the case immediately after FDA approvals- the time between approval and commercial launch is usually months, and that is why - in my opinion - there is time for these games to be played; because even after a commercial launch, it'll still be months before the investor has a good idea of how much revenue is coming in.
That's why these days the small investor can't count on banking some profits immediately after approval - we need to have a longer term outlook to realize the expected gains; however, with that said, there is usually plenty of volatility leading up to the FDA approval that allows investors to do a bit of trading in order to end up on house money by the time D-day comes.
If you were positive on DDSS before the FDA decision, then there's no reason to change your position now - just keep patient and look for news regarding a partnership announcement, commercial launch and ultimately, the revenue generation for OLEPTRO could be significant.
All just my opinion, each investor should do his or her own DD.
http://seekingalpha.com/article/186526-labopharm-just-became…
Fazit:
Labopharm wurde mitte Januar für 1,5 Euro vor der FDA-Zulassung erworben in der Erwartung, daß nach einer solchen Zulassung dem Unternehmen eine höhere Bewertung, durch mehr Sicherheit und den anstehenden Vermarktungschancen, zugesprochen wird.
Nun, da das Rudel von Raubtieren über den Wert herfällt, ist die Bewertung wieder auf dem Ursprungsniveau angekommen. Sehr schön wird diese Vorgehensweise im zitierten Bericht dokumentiert.
Labopharm wird jetzt mit 100 Mill. Dollar an der Börse bewertet. Es wird kurzfristig die Vermarktungskonzeption von Trazadol publiziert. Im Jahr 2009 macht das Unternehmen etwa 20 Mill. Dollar Umsatz. In 2010 kann der Umsatz mehr als verdoppelt werden aus der Vermarktung von 2 zugelassenen Medikamenten. In 2011 kann der Umsatz dann die 100 Mill. Dollar Grenze überschreiten. Für eine dann profitables Unternehmen, mit drei zugelassenen Medikamenten wird i.d.R. ein mehrfaches des Jahresumsatzes bezahlt. Gute Aussichten also für ein mittelfristiges Investment.
oder wie wird aus einem kurzfristigen Spiel ein mittelfristiges Investment!
Labopharm Just Became a Great Growth Stock
According to the Wednesday morning press release, the company expects to have OLEPTRO available for prescription in the United States later this year.
After spiking to nearly $3 on the market open, shares of DDSS traded down roughly to the $2.70 mark as the morning progressed, although volume was extremely heavy; the first hour of trading saw more than ten times the average daily volume change hands.
The modest bump in price did not meet the expectations of many investors, although it's my opinion that the February 3rd approval may have caught some off-guard since February 11th was expected to be the decision-day; and the FDA has been running behind schedule at that.
The booming volume would indicate that there are big players taking positions in the stock, and although OLEPTRO won't make it to market until later this year, the potential for a short term bump in price still exists since Wednesday's PR mentioned that the company "currently expects to finalize the commercialization plan for OLEPTRO[TM] in the near term."
That means partnership news can come at any time.
With an approved product in a very large market, DDSS should be considered a nice long term growth play, one that also could become a nice short to mid term story if the stock starts trading to its potential.
These days in the biotech sector it looks more and more like large investors like to see revenue before running the stock, but the small investor needs to have the patience to wait for the run.
Remember, the big boys will play their games and eat their cake, we're just trying to pick up a few crumbs along the way.
DDSS just became a great growth stock, in my opinion, especially since the share price hasn't changed on what should be considered big news.
Also worth mentioning is the possibility of dilution, although a partnership deal could bring enough of an upfront payment to LaboPharm to negate the need for raising a large sum of cash through stock sales.
UPDATE (after market close):
An early day price spike to nearly three dollars preceded the downturn that saw DDSS trade for as low as $2.17, before closing the day at $2.21. Volume remained very strong throughout the day, as expected after such news.
These days, it's not unusual to see such a drop in price after positive FDA approval news (see: BDSI, NRIFF.PK, etc); and although it's a bit nerve-shattering for longs of the stock to watch, it's actually nothing to complain about because it gives small investors the chance to buy shares of a company with an approved drug for the same price - or less - that just days before would have bought a more speculative company with an uncertain FDA decision looming.
Even when the stock trades down after positive news, it's still a better buy today than it was yesterday because of the increased certainty that the company will be able to generate revenue over the mid to long term.
However, it's because of scenarios like this one that demonstrate the need of the small investor to base investment decision on his or her own DD - and not the message boards, blogs or unexpected price swings; in the confusion it's a whole lot easier to sell into the uncertainty and move on, but an investor who is confident in the DD will have the fortitude to stick it out, maybe add some shares on the dip, and look towards the future.
The small investor cannot influence the stock price, the stock price will do what the big boys want it to do; it's up to the small investor to be on top of his or her game and to take advantage of the volatility and manipulation (if in fact manipulation is at play) . In this case it's a buying opportunity that has been presented, in my opinion.
When discussing possible manipulation, you can't ignore the fact that when the big boys want a stock to drop, they get their minions - that I like to call riff-raff - to swarm the message boards with multiple user IDs whose orders are to create a mood of confusion, panic, fear and uncertainty. Many small investors cannot handle the desperation that comes with all of those emotions and will therefore sell their shares (either for a loss or not as much profit as they could have banked by selling earlier) and play right into the hands of the riff-raff.
Once the stock has dropped and the riff-raff are somewhat satisfied with the amount of shares that they've shaken loose, they disappear off the message boards just as quickly as they showed up. Many will deny that such manipulation takes place, but after seeing the same game quite a few times, you'll feel a lot more comfortable holding through the storm, and possibly even adding a few shares.
Don't get me wrong, if something changes with the company that you're investing in that fits your 'exit strategy' protocol, then it may be wise to completely bail out. But if it's a secondary variable that is impacting the share price of your stock, and not actually events related to the company, then rely on your DD and stick to your entry/exit strategies.
It always comes back to DD and patience - and to not being afraid to take some profit off the table when the opportunity arises.
In the case of DDSS - as is usually the case immediately after FDA approvals- the time between approval and commercial launch is usually months, and that is why - in my opinion - there is time for these games to be played; because even after a commercial launch, it'll still be months before the investor has a good idea of how much revenue is coming in.
That's why these days the small investor can't count on banking some profits immediately after approval - we need to have a longer term outlook to realize the expected gains; however, with that said, there is usually plenty of volatility leading up to the FDA approval that allows investors to do a bit of trading in order to end up on house money by the time D-day comes.
If you were positive on DDSS before the FDA decision, then there's no reason to change your position now - just keep patient and look for news regarding a partnership announcement, commercial launch and ultimately, the revenue generation for OLEPTRO could be significant.
All just my opinion, each investor should do his or her own DD.
http://seekingalpha.com/article/186526-labopharm-just-became…
Fazit:
Labopharm wurde mitte Januar für 1,5 Euro vor der FDA-Zulassung erworben in der Erwartung, daß nach einer solchen Zulassung dem Unternehmen eine höhere Bewertung, durch mehr Sicherheit und den anstehenden Vermarktungschancen, zugesprochen wird.
Nun, da das Rudel von Raubtieren über den Wert herfällt, ist die Bewertung wieder auf dem Ursprungsniveau angekommen. Sehr schön wird diese Vorgehensweise im zitierten Bericht dokumentiert.
Labopharm wird jetzt mit 100 Mill. Dollar an der Börse bewertet. Es wird kurzfristig die Vermarktungskonzeption von Trazadol publiziert. Im Jahr 2009 macht das Unternehmen etwa 20 Mill. Dollar Umsatz. In 2010 kann der Umsatz mehr als verdoppelt werden aus der Vermarktung von 2 zugelassenen Medikamenten. In 2011 kann der Umsatz dann die 100 Mill. Dollar Grenze überschreiten. Für eine dann profitables Unternehmen, mit drei zugelassenen Medikamenten wird i.d.R. ein mehrfaches des Jahresumsatzes bezahlt. Gute Aussichten also für ein mittelfristiges Investment.
Watchlist: Silicon Sensor Übernahme durch Augusta?
Im aktuellen Platow-Brief steht Augusta auf dem Prüfstand! Augusta
wird als Highlight des Close Brothers Mid&Small Conference zitiert.
Alles Wiederholungen der Spekulationen über Nov., Hopp und Silicon Sensor sind im Artikel hervorgehoben. Ansonsten wird nur gesagt, daß dieses Jahr mit Verstärkung des Vorstands ernst gemacht wird.
Zum Preis wird nichts gesagt.
Wenn SIS derzeit für 35 Mio. Euro zu haben ist, bin ich glaube ich kein Prophet, das SIS für 40 - 50 Mio. über den Tisch gehen könnte.
Viel interessanter ist das letzte Interview aus Jan. 2010 des Augusta Vorstands, wonach man eine ähnliche 1. Akquisition ohne Verwässerung stemmen könnte, 1 Mio. Aktien + Cash + Fremdkapital. Dennoch bleibt es dabei, daß für Augusta dies eine Option für die Zukunft bedeutet, dennoch dürfte der Gewinnbeitrag in 2010 sich in Grenzen halten.
Fazit: Kommt es tatsächlich zu einer Übernahme zwischen 40-50 Mill. Euro wird dies für Augusta eher mittelfristiges Potenzial eröffnen, während für SIS-Aktionäre ein Übernahmeangebot einen Kurssprung von ca 20 % ergeben könnte.
Im aktuellen Platow-Brief steht Augusta auf dem Prüfstand! Augusta
wird als Highlight des Close Brothers Mid&Small Conference zitiert.
Alles Wiederholungen der Spekulationen über Nov., Hopp und Silicon Sensor sind im Artikel hervorgehoben. Ansonsten wird nur gesagt, daß dieses Jahr mit Verstärkung des Vorstands ernst gemacht wird.
Zum Preis wird nichts gesagt.
Wenn SIS derzeit für 35 Mio. Euro zu haben ist, bin ich glaube ich kein Prophet, das SIS für 40 - 50 Mio. über den Tisch gehen könnte.
Viel interessanter ist das letzte Interview aus Jan. 2010 des Augusta Vorstands, wonach man eine ähnliche 1. Akquisition ohne Verwässerung stemmen könnte, 1 Mio. Aktien + Cash + Fremdkapital. Dennoch bleibt es dabei, daß für Augusta dies eine Option für die Zukunft bedeutet, dennoch dürfte der Gewinnbeitrag in 2010 sich in Grenzen halten.
Fazit: Kommt es tatsächlich zu einer Übernahme zwischen 40-50 Mill. Euro wird dies für Augusta eher mittelfristiges Potenzial eröffnen, während für SIS-Aktionäre ein Übernahmeangebot einen Kurssprung von ca 20 % ergeben könnte.
Quanmax: Kurserwartung Ende 2010 4 Euro!
DJ DGAP-Adhoc: Quanmax AG erhält Ausfallsbürgschaft des..
08:30
Landes Oberösterreich
Quanmax AG / Sonstiges
03.02.2010
Veröffentlichung einer Ad-hoc-Mitteilung nach § 15 WpHG,
übermittelt
durch die DGAP - ein Unternehmen der EquityStory AG.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
--------------------------------------------------------------------------
Quanmax AG erhält Ausfallsbürgschaft des Landes Oberösterreich
Die Quanmax AG hat vom Land Oberösterreich auf Grundlage des vom
oberösterreichischen Landtag am 2.4.2009 beschlossenen Haftungsmodells
eine
Ausfallsbürgschaft über 80 Prozent einer zusätzlichen
6-Millionen-Euro-Finanzierung bekommen. Der Kredit über 6 Millionen Euro,
der von einem Bankenkonsortium bestehend aus BAWAG und Volksbank
bereitgestellt wird, soll als Working Capital das weitere Wachstum und die
Expansion des Unternehmens sicherstellen. In Zeiten der internationalen
Kreditklemme sind Liquidität und ausreichende Kreditlinien für den
Computerhersteller ein Schlüsselfaktor, um seinen Marktanteil und die
Arbeitsplätze in Österreich abzusichern.
Bereits im November 2009 wurde die Eigenkapitalquote des Unternehmens durch
eine Kapitalerhöhung von 8,3 Mio. EUR auf rund 50 Prozent gesteigert. Mit
dem neuen Kreditrahmen wurden nun auch Liquiditätsengpässe beseitigt,
die
in der Vergangenheit zu Problemen bei der Abwicklung von Großprojekten
geführt hatten. Trotz des schwierigen Marktumfeldes geht das Management
für
2009 von einem Nettogewinn von 2 bis 3 Millionen Euro aus. Damit ist die
Restrukturierung des Unternehmens sowohl operativ als auch bilanziell
erfolgreich abgeschlossen.
Zukünftig will die Quanmax AG mit Produkten mit ausgezeichnetem
Preis/Leistungsverhältnis sowie besonders flexibler Projektabwicklung
neben
dem starkem Österreich-Geschäft auch in Osteuropa, Deutschland und
der
Schweiz mitmischen. Dabei sollen durch mehr Wertschöpfung in
Österreich
zudem bereits mittelfristig technologische und logistische
Alleinstellungsmerkmale geschaffen werden.
Die börsennotierte Quanmax AG ist mit den Marken chiliGREEN, *G, und
Maxdata einer der größten Vermarkter von IT-Hardware in
Österreich. Das
Unternehmen fertigt Notebooks, PCs, externe Festplatten und Server, die
über namhafte Handelspartner, Fachhändler und online vertrieben
werden. Am
Linzer Standort beschäftigt das Unternehmen über 100 Mitarbeiter.
03.02.2010 Ad-hoc-Meldungen, Finanznachrichten und Pressemitteilungen
übermittelt durch die DGAP.
Medienarchiv unter http://www.dgap-medientreff.de und http://www.dgap.de
--------------------------------------------------------------------------
Sprache: Deutsch
Unternehmen: Quanmax AG
Industriezeile 35
4021 Linz
Österreich
Telefon: +43 (732) 7664 - 0
Fax: +43 (732) 7664 - 801
E-Mail: ir@quanmax.ag
Internet: www.quanmax.ag
ISIN: AT0000A0E9W5
WKN: A0X9EJ
Börsen: Regulierter Markt in Frankfurt (General Standard);
Freiverkehr in Berlin, München, Düsseldorf, Stuttgart,
Hamburg
Ende der Mitteilung DGAP News-Service
--------------------------------------------------------------------------
(END) Dow Jones Newswires
February 03, 2010 02:30 ET (07:30 GMT)
020310 07:30 -- GMT
© DJV
Das ist die Reaktion des Marktes in einem schlechten Umfeld:
DJ DGAP-Adhoc: Quanmax AG erhält Ausfallsbürgschaft des..
08:30
Landes Oberösterreich
Quanmax AG / Sonstiges
03.02.2010
Veröffentlichung einer Ad-hoc-Mitteilung nach § 15 WpHG,
übermittelt
durch die DGAP - ein Unternehmen der EquityStory AG.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
--------------------------------------------------------------------------
Quanmax AG erhält Ausfallsbürgschaft des Landes Oberösterreich
Die Quanmax AG hat vom Land Oberösterreich auf Grundlage des vom
oberösterreichischen Landtag am 2.4.2009 beschlossenen Haftungsmodells
eine
Ausfallsbürgschaft über 80 Prozent einer zusätzlichen
6-Millionen-Euro-Finanzierung bekommen. Der Kredit über 6 Millionen Euro,
der von einem Bankenkonsortium bestehend aus BAWAG und Volksbank
bereitgestellt wird, soll als Working Capital das weitere Wachstum und die
Expansion des Unternehmens sicherstellen. In Zeiten der internationalen
Kreditklemme sind Liquidität und ausreichende Kreditlinien für den
Computerhersteller ein Schlüsselfaktor, um seinen Marktanteil und die
Arbeitsplätze in Österreich abzusichern.
Bereits im November 2009 wurde die Eigenkapitalquote des Unternehmens durch
eine Kapitalerhöhung von 8,3 Mio. EUR auf rund 50 Prozent gesteigert. Mit
dem neuen Kreditrahmen wurden nun auch Liquiditätsengpässe beseitigt,
die
in der Vergangenheit zu Problemen bei der Abwicklung von Großprojekten
geführt hatten. Trotz des schwierigen Marktumfeldes geht das Management
für
2009 von einem Nettogewinn von 2 bis 3 Millionen Euro aus. Damit ist die
Restrukturierung des Unternehmens sowohl operativ als auch bilanziell
erfolgreich abgeschlossen.
Zukünftig will die Quanmax AG mit Produkten mit ausgezeichnetem
Preis/Leistungsverhältnis sowie besonders flexibler Projektabwicklung
neben
dem starkem Österreich-Geschäft auch in Osteuropa, Deutschland und
der
Schweiz mitmischen. Dabei sollen durch mehr Wertschöpfung in
Österreich
zudem bereits mittelfristig technologische und logistische
Alleinstellungsmerkmale geschaffen werden.
Die börsennotierte Quanmax AG ist mit den Marken chiliGREEN, *G, und
Maxdata einer der größten Vermarkter von IT-Hardware in
Österreich. Das
Unternehmen fertigt Notebooks, PCs, externe Festplatten und Server, die
über namhafte Handelspartner, Fachhändler und online vertrieben
werden. Am
Linzer Standort beschäftigt das Unternehmen über 100 Mitarbeiter.
03.02.2010 Ad-hoc-Meldungen, Finanznachrichten und Pressemitteilungen
übermittelt durch die DGAP.
Medienarchiv unter http://www.dgap-medientreff.de und http://www.dgap.de
--------------------------------------------------------------------------
Sprache: Deutsch
Unternehmen: Quanmax AG
Industriezeile 35
4021 Linz
Österreich
Telefon: +43 (732) 7664 - 0
Fax: +43 (732) 7664 - 801
E-Mail: ir@quanmax.ag
Internet: www.quanmax.ag
ISIN: AT0000A0E9W5
WKN: A0X9EJ
Börsen: Regulierter Markt in Frankfurt (General Standard);
Freiverkehr in Berlin, München, Düsseldorf, Stuttgart,
Hamburg
Ende der Mitteilung DGAP News-Service
--------------------------------------------------------------------------
(END) Dow Jones Newswires
February 03, 2010 02:30 ET (07:30 GMT)
020310 07:30 -- GMT
© DJV
Das ist die Reaktion des Marktes in einem schlechten Umfeld:
Antwort auf Beitrag Nr.: 38.877.128 von testersteron am 04.02.10 09:25:10Schaue Dir einfach den letzten Bericht an und mach Dir ein Bild:
http://www.labopharm.com/images/pdf_img.gif
Wir sind jetzt auf ein Niveau zurückgefallen, bei dem wir weit vor der Zulassung waren und haben 25 % abgegeben. Die Company ist noch 100 Mill. Dollar wert. Das könnte der Umsatz vom nächsten Jahr sein. Normalerweise sind solche Companies mit mit dem 3-4 fachen Umsatz bewertet. Ich wäre schon sehr überrascht, wenn wir nicht auch eine Gegenbewegung im Kurs sehen. Hängt natürlich auch an dem Umfeld.
Gruß
http://www.labopharm.com/images/pdf_img.gif
Wir sind jetzt auf ein Niveau zurückgefallen, bei dem wir weit vor der Zulassung waren und haben 25 % abgegeben. Die Company ist noch 100 Mill. Dollar wert. Das könnte der Umsatz vom nächsten Jahr sein. Normalerweise sind solche Companies mit mit dem 3-4 fachen Umsatz bewertet. Ich wäre schon sehr überrascht, wenn wir nicht auch eine Gegenbewegung im Kurs sehen. Hängt natürlich auch an dem Umfeld.
Gruß
Ist Labopharm jetzt ein Kauf oder sollte man noch warten?
Trading Spotlight
Antwort auf Beitrag Nr.: 38.851.334 von Kleiner Chef am 31.01.10 17:39:26Labopharm: Die Zulassung ist da!
Labopharm's Antidepressant Gets FDA Approval; Commercialization Plan In The Works - Update
2/3/2010 9:42 AM ET
RELATED NEWS
FDA Okays Labopharm's Oleptro To Treat Major Depressive Disorder In Adults; Shares Surge - Update
U.S. FDA Approves Labopharm's OLEPTRO Extended Release Tablets - Quick Facts
Labopharm Inc. - Awaiting FDA Decision
Labopharm Enters Into C$25 Mln Standby Equity Distribution Agreement With YA Global Master SPV - Quick Facts
Labopharm Q3 Loss Widens
Trade DDSS now with
(RTTNews) - Labopharm Inc. (DDSS: News ) (DDS.TO: News ) has every reason to cheer and investors are in high spirits. The shares traded as high as $3.74 in pre-market trading on Wednesday, an increase of 43% from the previous day's close of $2.61.
The FDA, which was scheduled to make a decision on the company's novel once-daily formulation of the antidepressant trazodone, now branded as Oleptro Extended Release Tablets, for the treatment of major depressive disorder in adults on February 11, approved the drug today, a week ahead of its deadline. RTTNews had alerted readers about the impending FDA decision on January 20.
Major depressive disorder or MDD is a common mental illness and it affects more than 14 million adults in the U.S. The U.S. antidepressant market is estimated to be in excess of $11 billion.
The company said it has completed market research with physicians and third-party payors, developed a positioning and marketing campaign for the drug and finalized product manufacturing and packaging arrangements.
Labopharm expects Oleptro to be available for prescription in the U.S. later this year, with specific timing for its launch to be determined within the context of the final commercialization plan. The company is also actively exploring several alternatives for the U.S. commercialization of the drug and a commercialization plan is expected to be finalized in the near term
Einschätzung: Sell on good news findet heute statt. 50 % der ausstehenden Aktien wechseln heute den Besitzer. Dannach kann man in die nächste Phase gespannt erwarten, die Vermarktungskonzeption mit Bekanntgabe des Partners sowie der Launch des Produkt. Nach den News ist bekanntlich vor den News. Und die werden bald kommen.
Labopharm's Antidepressant Gets FDA Approval; Commercialization Plan In The Works - Update
2/3/2010 9:42 AM ET
RELATED NEWS
FDA Okays Labopharm's Oleptro To Treat Major Depressive Disorder In Adults; Shares Surge - Update
U.S. FDA Approves Labopharm's OLEPTRO Extended Release Tablets - Quick Facts
Labopharm Inc. - Awaiting FDA Decision
Labopharm Enters Into C$25 Mln Standby Equity Distribution Agreement With YA Global Master SPV - Quick Facts
Labopharm Q3 Loss Widens
Trade DDSS now with
(RTTNews) - Labopharm Inc. (DDSS: News ) (DDS.TO: News ) has every reason to cheer and investors are in high spirits. The shares traded as high as $3.74 in pre-market trading on Wednesday, an increase of 43% from the previous day's close of $2.61.
The FDA, which was scheduled to make a decision on the company's novel once-daily formulation of the antidepressant trazodone, now branded as Oleptro Extended Release Tablets, for the treatment of major depressive disorder in adults on February 11, approved the drug today, a week ahead of its deadline. RTTNews had alerted readers about the impending FDA decision on January 20.
Major depressive disorder or MDD is a common mental illness and it affects more than 14 million adults in the U.S. The U.S. antidepressant market is estimated to be in excess of $11 billion.
The company said it has completed market research with physicians and third-party payors, developed a positioning and marketing campaign for the drug and finalized product manufacturing and packaging arrangements.
Labopharm expects Oleptro to be available for prescription in the U.S. later this year, with specific timing for its launch to be determined within the context of the final commercialization plan. The company is also actively exploring several alternatives for the U.S. commercialization of the drug and a commercialization plan is expected to be finalized in the near term
Einschätzung: Sell on good news findet heute statt. 50 % der ausstehenden Aktien wechseln heute den Besitzer. Dannach kann man in die nächste Phase gespannt erwarten, die Vermarktungskonzeption mit Bekanntgabe des Partners sowie der Launch des Produkt. Nach den News ist bekanntlich vor den News. Und die werden bald kommen.
Labopharm: Kurserwartung Ende 2010 4 Euro!
Die wohl kurzfristig spannendste Aktie im Depot ist Labopharm, da am 11.02 das FDA-Approval für das Anti-Drepressivum Trazodone ansteht:
Labopharm’s new antidepressant to be ‘game-changer’
January 26, 2010 by leonardzehr · Leave a Comment
It’s game on for Labopharm (TSX
DS (2.79 ↑1.82%); NASDAQDSS).
By February 11, the FDA is expected to approve the company’s antidepressant trazodone, a novel once-daily formulation that addresses many of the shortcomings of similar drugs on the market. “I think it’s fair to say this drug could be a game-changer for us,” CEO James Howard-Tripp says in an exclusive interview with BioTuesday.ca. “Clearly, it has the potential to be a bigger drug for us than tramadol.”
Labopharm’s once-daily tramadol pain drug has been launched in 17 countries and is generating top line sales of $100 million a year. “That drops about $20 million down to us, of which we have a gross margin of 55% to 60%,” he adds.
“2010 is clearly a pivotal year,” he contends. “Tramadol is making decent money; we would like it to make more, so we will make a strong push to do that. With the possible approval of trazodone right around the corner and then a launch, this has opportunity to put us into a different space. And we have the opportunity for a third drug approval by year-end. So, there are not very many organizations in our position that can show that.”
In mid-December, Labopharm filed regulatory documents in Europe to clear its twice-daily tramadol-acetaminophen drug for acute pain, with the review process likely to take 12 months. It also lined up Germany’s Grunenthal to distribute and market the drug in a number of European countries. Grunenthal currently markets Labopharm’s once-daily tramadol in France and Belgium.
But for now, all attention is focused on trazodone.
The annual U.S. market for antidepressants is more than $12 billion (U.S.). According to Labopharm, shortcomings with the current standard of care, namely serotonin-specific reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), may force 28% of patients to stop therapy in the first four weeks and 44% in the first 12 weeks. The reasons: less than optimal efficacy, slow onset of action, increased sleep disturbance and agitation, sexual dysfunction and weight gain.
Mr. Howard-Tripp explains that trazodone needs to be dosed at 300 milligrams a day in order to get true antidepressant efficacy. But because it was a three-times-a day dose, it often results in an undue level of next day drowsiness.
“What we’ve been able to do with our once-a-day is to make it to be used at the 300-mg level, with the full antidepressant effect, and a positive effect on sleep but without the undue level of next day drowsiness.” It also has a fast onset of action and does not exhibit drug-induced sexual dysfunction or drug-induced weight gain.
Dundee Securities analyst David Martin points out that trazodone’s barrier to market entry should be lower, because “all currently approved antidepressants have similar efficacy, making the side effect profile an important differentiator.”
Labopharm plans to sign a marketing partner for trazodone after it receives FDA approval. “We are comfortable with that,” Mr. Howard-Tripp says, adding that launch preparations and planning have been underway for well over a year.
Dundee’s Mr. Martin figures a partnership could bring Labopharm an upfront payment in the range of $10 million to $20 million.
While Labopharm’s tramadol pain drug holds the largest market share for once-daily tramadol products in Canada and Europe, sales in the U.S. have remained below expectations since the May 2009 launch by marketing partner, Purdue Pharma. The reason: the threat of generic competition.
There are at least two tramadol copycats being sold in the U.S. now, but Mr. Howard-Tripp says neither is a “generic formulation of our product, so they are not substitutable for our formulation at the pharmacy.”
Moreover, he said, “Purdue has come back to us and confirmed that they think this is an important product in their portfolio, and their intent is to continue promoting the drug.”
Despite the challenging market conditions in the U.S., “neither one of us is happy with the performance to date,” he admits. “We have a number of strategies on the table to increase the value of the product. Unfortunately, people are just going to have to wait a while to see how that plays out.”
Last April, Labopharm reported pivotal results of efficacy from its tramadol-acetaminophen drug for acute low back pain that demonstrated a “statistically significant difference from placebo in some cases but not in others.” Citing different requirements for the analysis of efficacy by regulators around the world, the company acknowledged the trial results were “likely insufficient” for an FDA filing but strong enough for filings in Europe and Canada.
Mr. Howard-Tripp says the company plans to meet with the FDA soon to review the data and whether it is sufficient to file. “If it is, we’ll go ahead and file. If it isn’t, we’ll adjust according to what else we need. If another pivotal trial is needed, then yes we would go ahead.”
Acute pain, which can last from several days to six months and covers arthritic conditions, represents 40% of the $30 billion global analgesic market. Labopharm’s solution is a twice-daily pill that offers acetaminophen for rapid onset of action and tramadol for analgesic strength in order to reduce the potential for opioid-related side effects, among other things.
“We are excited about this drug,” Mr. Howard-Tripp says. “We’ve had a lot of interest from a number of players around the world. So we are going to continue to file in global jurisdictions and continue to partner the drug.”
And as Labopharm pushes along several pipeline projects, the company appears ready to turn the page on merely using formulation technologies to address limitations in the action of FDA-approved drugs. “You will also see us beginning to go a little deeper as we move, not necessarily into new chemical entities, but certainly more towards that as we try to get products that have very high rewards,” he contends.
Another hallmark for 2010 will be a very strong commercial bias, he adds. “We have a clear intent as we move out down the road to be able to not only develop our own drugs but to commercialize our own drugs. A very small and focused sales force will be considered.”
Asked about co-promoting trazodone, he says “we have had our best success all over the world wherever we have been very involved in the sales and marketing process with our partners. We made the comment some time ago that it will be unlikely that we will simply hand over future drugs. We would always want to have a role in it with the partner.”
Die wohl kurzfristig spannendste Aktie im Depot ist Labopharm, da am 11.02 das FDA-Approval für das Anti-Drepressivum Trazodone ansteht:
Labopharm’s new antidepressant to be ‘game-changer’
January 26, 2010 by leonardzehr · Leave a Comment
It’s game on for Labopharm (TSX
DS (2.79 ↑1.82%); NASDAQDSS).By February 11, the FDA is expected to approve the company’s antidepressant trazodone, a novel once-daily formulation that addresses many of the shortcomings of similar drugs on the market. “I think it’s fair to say this drug could be a game-changer for us,” CEO James Howard-Tripp says in an exclusive interview with BioTuesday.ca. “Clearly, it has the potential to be a bigger drug for us than tramadol.”
Labopharm’s once-daily tramadol pain drug has been launched in 17 countries and is generating top line sales of $100 million a year. “That drops about $20 million down to us, of which we have a gross margin of 55% to 60%,” he adds.
“2010 is clearly a pivotal year,” he contends. “Tramadol is making decent money; we would like it to make more, so we will make a strong push to do that. With the possible approval of trazodone right around the corner and then a launch, this has opportunity to put us into a different space. And we have the opportunity for a third drug approval by year-end. So, there are not very many organizations in our position that can show that.”
In mid-December, Labopharm filed regulatory documents in Europe to clear its twice-daily tramadol-acetaminophen drug for acute pain, with the review process likely to take 12 months. It also lined up Germany’s Grunenthal to distribute and market the drug in a number of European countries. Grunenthal currently markets Labopharm’s once-daily tramadol in France and Belgium.
But for now, all attention is focused on trazodone.
The annual U.S. market for antidepressants is more than $12 billion (U.S.). According to Labopharm, shortcomings with the current standard of care, namely serotonin-specific reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), may force 28% of patients to stop therapy in the first four weeks and 44% in the first 12 weeks. The reasons: less than optimal efficacy, slow onset of action, increased sleep disturbance and agitation, sexual dysfunction and weight gain.
Mr. Howard-Tripp explains that trazodone needs to be dosed at 300 milligrams a day in order to get true antidepressant efficacy. But because it was a three-times-a day dose, it often results in an undue level of next day drowsiness.
“What we’ve been able to do with our once-a-day is to make it to be used at the 300-mg level, with the full antidepressant effect, and a positive effect on sleep but without the undue level of next day drowsiness.” It also has a fast onset of action and does not exhibit drug-induced sexual dysfunction or drug-induced weight gain.
Dundee Securities analyst David Martin points out that trazodone’s barrier to market entry should be lower, because “all currently approved antidepressants have similar efficacy, making the side effect profile an important differentiator.”
Labopharm plans to sign a marketing partner for trazodone after it receives FDA approval. “We are comfortable with that,” Mr. Howard-Tripp says, adding that launch preparations and planning have been underway for well over a year.
Dundee’s Mr. Martin figures a partnership could bring Labopharm an upfront payment in the range of $10 million to $20 million.
While Labopharm’s tramadol pain drug holds the largest market share for once-daily tramadol products in Canada and Europe, sales in the U.S. have remained below expectations since the May 2009 launch by marketing partner, Purdue Pharma. The reason: the threat of generic competition.
There are at least two tramadol copycats being sold in the U.S. now, but Mr. Howard-Tripp says neither is a “generic formulation of our product, so they are not substitutable for our formulation at the pharmacy.”
Moreover, he said, “Purdue has come back to us and confirmed that they think this is an important product in their portfolio, and their intent is to continue promoting the drug.”
Despite the challenging market conditions in the U.S., “neither one of us is happy with the performance to date,” he admits. “We have a number of strategies on the table to increase the value of the product. Unfortunately, people are just going to have to wait a while to see how that plays out.”
Last April, Labopharm reported pivotal results of efficacy from its tramadol-acetaminophen drug for acute low back pain that demonstrated a “statistically significant difference from placebo in some cases but not in others.” Citing different requirements for the analysis of efficacy by regulators around the world, the company acknowledged the trial results were “likely insufficient” for an FDA filing but strong enough for filings in Europe and Canada.
Mr. Howard-Tripp says the company plans to meet with the FDA soon to review the data and whether it is sufficient to file. “If it is, we’ll go ahead and file. If it isn’t, we’ll adjust according to what else we need. If another pivotal trial is needed, then yes we would go ahead.”
Acute pain, which can last from several days to six months and covers arthritic conditions, represents 40% of the $30 billion global analgesic market. Labopharm’s solution is a twice-daily pill that offers acetaminophen for rapid onset of action and tramadol for analgesic strength in order to reduce the potential for opioid-related side effects, among other things.
“We are excited about this drug,” Mr. Howard-Tripp says. “We’ve had a lot of interest from a number of players around the world. So we are going to continue to file in global jurisdictions and continue to partner the drug.”
And as Labopharm pushes along several pipeline projects, the company appears ready to turn the page on merely using formulation technologies to address limitations in the action of FDA-approved drugs. “You will also see us beginning to go a little deeper as we move, not necessarily into new chemical entities, but certainly more towards that as we try to get products that have very high rewards,” he contends.
Another hallmark for 2010 will be a very strong commercial bias, he adds. “We have a clear intent as we move out down the road to be able to not only develop our own drugs but to commercialize our own drugs. A very small and focused sales force will be considered.”
Asked about co-promoting trazodone, he says “we have had our best success all over the world wherever we have been very involved in the sales and marketing process with our partners. We made the comment some time ago that it will be unlikely that we will simply hand over future drugs. We would always want to have a role in it with the partner.”
Siga Technology: Kurserwartung Ende 2010 15 Euro!
Welchen Anteil der Barda-Ausschreibung, deren Umfang im Mrd.-Bereich liegen wird, wird Siga erhalten?
Sseveral important inferences from this most recent set of Changes:
First, BARDA continues to actively pursue its objective to acquire a therapeutic smallpox antiviral drug into the Strategic National Stockpile.
Second, we believe SIGA remains uniquely qualified as an offeror for this RFP, with consistent evidence of the excellent therapeutic index of ST-246 in multiple non-human primate tests using the smallpox virus itself and monkeypox.
Third, proof of efficacy in non-human primates remains a substantial barrier to entry that our competitors will need to overcome to commercialize their product candidates. We believe we have at least a three year lead compared to any other potential product candidate in regard to non-human primate efficacy testing.
Will the changes in the RFP delay a contract for the RFP?
The original RFP solicitation stated the intent to come to contract by September 2009, while BARDA officials have previously stated their expectation to complete a contract by the end of calendar year 2009. We believe it is unlikely we will consummate a contract in this calendar year, but we have been engaged with BARDA contracting personnel in an active, diligent process regarding technical aspects of our proposal, physical and informational security at our laboratories and our manufacturing contractors’ plants, and pricing. We don’t believe that Friday’s amendments to the RFP will adversely affect our prospects in this process.
Also, we don’t believe the December 11th amendment will create a long process delay, so we continue to await the finalization of the amendment on or about December 28. We find this process to be entirely consistent with the contracting processes we have engaged in with HHS and DOD for our prior grants and contracts. We have the highest respect for the diligence and integrity of the process and our government partners.
If BARDA makes awards to multiple contractors, will that diminish SIGA’s share of the base acquisition of 1.7 million courses of drug?
While this is certainly possible, we believe we are best able to deliver the entire 1.7 million courses as rapidly as possible.
Our pricing proposal only contemplated an order for the entire 1.7 million courses. We believe that BARDA has shown an understanding both in this RFP and its acquisitions that lower volumes deserve higher unit pricing.
Will these delays postpone potential delivery of ST-246 into the strategic national stockpile?
We have already produced 20,000 courses of ST-246 in our FDA registration batches and plan to produce 300,000 more courses in early 2010 in our commercial validation process. This activity is funded by the $20 million increase to our ST-246 therapeutic development contract which BARDA awarded to us in September 2008.
We believe that if we complete a contract in the first quarter of 2010, we can fulfill our plan to begin delivery of our drug into the strategic national stockpile in late 2010.
Siga: Wert nach Auftragserteilung zwischen 11 - 26 Dollar!
SIGA Technologies (SIGA): Initiate coverage w/ Outperform; to be awarded a big gov. contract - RBC Capital
January 28, 2010 8:43 AM EST
From Notable Calls
RBC Capital is picking up coverage on SIGA Technologies (NASDAQ: SIGA) with Outperform rating and $11 price target, while noting that depending on contract size SIGA's NPV could be as high as $26/per share.
Firm notes their positive thesis is based on the likelihood that SIGA Technologies, Inc. will be awarded a lucrative contract under Project BioShield to supply the U.S. Government with its oral treatment for smallpox (ST-246, tecovirimat). SIGA shares traded lower following an unexpected amendment to the Request for Proposals (RFP), which they believe creates an attractive entry point. The timing of a contract is uncertain but is likely to occur in the firsthalf 2010. The recent negative assessment of the U.S. Government’s preparedness also increases political pressure to get a contract signed, in RBC's opinion. The simple oral dosing, compelling animal data, anecdotal efficacy in humans against related viral infections, and secure and audited supply chain make ST-246 an attractive asset to the U.S. Government and others interested in effective counter measures against smallpox.
Key Reasons to Expect BARDA Contract
- Small pox counter measures are a high priority at Biomedical Advanced Research and Development Authority (BARDA) given the vulnerability of the population following the discontinuation of routine vaccination in 1972.
- Only two known drugs are vying for the government contract, and the amended RFP permits the government to acquire both.
- ST-246 has demonstrated safety in humans and efficacy across multiple animal species, including non-human primates.
- This week a bipartisan commission issued a scathing report giving the U.S. Government an “F” for preparedness, increasing the political pressure for the government to act now.
Initial Contract worth Approximately $500 million; Expansion Potential to over $1 billion
- Assuming $250-300 per course of treatment and an initial contract for 1.7 million courses, the total sale could be $425-510 million over a three-year period.
- The initial contract has an option to expand to 12 million courses (a blockbuster opportunity even if price is adjusted downward for the increased volume).
- Other governments are likely to place orders after the United States
Competition – Room for Two Drugs
- Privately held Chimerix Inc. is developing a competitive agent for the treatment of smallpox. Because Chimerix is private, there are limited public disclosures regarding the status of its program.
- CMX001 is Chimerix’s oral version of the broadly active antiviral cidofovir. It is active in most animal models of smallpox but cannot be tested in non-human primates, which may provide a competitive advantage for SIGA because the RFP requires that the company demonstrates efficacy in non-human primates.
Governmental Purchasing and Regulation are the Key Risks
SIGA is seeking government contracts for ST-246. As a result, SIGA is dependent on the vagaries of timing, purchase size and pricing. The U.S. Government could also change its mind or amend the contract. In addition, gaining FDA approval will require SIGA to use the ‘animal rule’ because efficacy studies in humans are not possible with smallpox. Although there are guidelines for approval based on animal studies, the path is not well trodden, and there remains significant regulatory risk. FDA approval is not necessary for initial government purchases, but it may be required for longer-term contracts or sales in other countries.
Government Funding History Suggests Strong Interest in ST-246
Over the past-two years, SIGA has received contracts and grants totalling $78 million specifically for the development of ST-246. This amount includes a $55 million contract to develop alternative intravenous formulations of ST-246 for seriously ill patients and a $20 million extension to a $16.5 million, 2006, three-year contract for the development of ST-246. Given the government’s investment in this program, and the advanced stage of clinical and regulatory development of the program, we believe a contract to purchase ST-246 for the Strategic National Stockpile (SNS) is highly likely.
Notablecalls: SIGA Tech (SIGA) certainly presents an interesting situation for traders here as RBC Capital seems to be the 1st firm to pick up coverage on this biodefense name. Biodefense (and homeland def. in general) has become a hit topic once again & contracts usually follow.
Note that SIGA has a long history getting funding from the U.S. Government. Since 2004, SIGA has secured approximately $122 million in government grants, contracts and awards to fund the development of ST-246 and other novel antiviral agents.
I really don't think the Government will leave SIGA empty-handed after plowing $100m+ into the co.
As noted, RBC estimates the stock could be worth up to $26 if everything goes right. That's some upside.
I think this call will get traders' attention and will serve to push the stock higher by 10%+, putting $7 level possibly in plays.
Fazit:
Bekanntlich ist an der Börse nichts sicher. Aber es gibt wahrscheinliche Szenarien und unwahrscheinliche. Das aufgezeigte Szenario gehört wohl zu den wahrscheinlichen. Der Eintritt ist zeitlich im 1. Halbjahr 2010 zu erwarten. Die Zeit spricht für Siga, da der Druck umso stärker wächst, je mehr Nachfrage nach ST-246 für Emergency Use eintritt, wie zuletzt von Israel:
"While no drug was actually delivered in this exercise, Israeli authorities told us they had arranged for immediate transportation of as many courses as we could provide, fully understanding that our drug candidate is under advanced development with BARDA and not registered with FDA," said Eric A. Rose, MD, SIGA's Chief Executive Officer.
http://investor.siga.com/releasedetail.cfm?ReleaseID=438564
Welchen Anteil der Barda-Ausschreibung, deren Umfang im Mrd.-Bereich liegen wird, wird Siga erhalten?
Sseveral important inferences from this most recent set of Changes:
First, BARDA continues to actively pursue its objective to acquire a therapeutic smallpox antiviral drug into the Strategic National Stockpile.
Second, we believe SIGA remains uniquely qualified as an offeror for this RFP, with consistent evidence of the excellent therapeutic index of ST-246 in multiple non-human primate tests using the smallpox virus itself and monkeypox.
Third, proof of efficacy in non-human primates remains a substantial barrier to entry that our competitors will need to overcome to commercialize their product candidates. We believe we have at least a three year lead compared to any other potential product candidate in regard to non-human primate efficacy testing.
Will the changes in the RFP delay a contract for the RFP?
The original RFP solicitation stated the intent to come to contract by September 2009, while BARDA officials have previously stated their expectation to complete a contract by the end of calendar year 2009. We believe it is unlikely we will consummate a contract in this calendar year, but we have been engaged with BARDA contracting personnel in an active, diligent process regarding technical aspects of our proposal, physical and informational security at our laboratories and our manufacturing contractors’ plants, and pricing. We don’t believe that Friday’s amendments to the RFP will adversely affect our prospects in this process.
Also, we don’t believe the December 11th amendment will create a long process delay, so we continue to await the finalization of the amendment on or about December 28. We find this process to be entirely consistent with the contracting processes we have engaged in with HHS and DOD for our prior grants and contracts. We have the highest respect for the diligence and integrity of the process and our government partners.
If BARDA makes awards to multiple contractors, will that diminish SIGA’s share of the base acquisition of 1.7 million courses of drug?
While this is certainly possible, we believe we are best able to deliver the entire 1.7 million courses as rapidly as possible.
Our pricing proposal only contemplated an order for the entire 1.7 million courses. We believe that BARDA has shown an understanding both in this RFP and its acquisitions that lower volumes deserve higher unit pricing.
Will these delays postpone potential delivery of ST-246 into the strategic national stockpile?
We have already produced 20,000 courses of ST-246 in our FDA registration batches and plan to produce 300,000 more courses in early 2010 in our commercial validation process. This activity is funded by the $20 million increase to our ST-246 therapeutic development contract which BARDA awarded to us in September 2008.
We believe that if we complete a contract in the first quarter of 2010, we can fulfill our plan to begin delivery of our drug into the strategic national stockpile in late 2010.
Siga: Wert nach Auftragserteilung zwischen 11 - 26 Dollar!
SIGA Technologies (SIGA): Initiate coverage w/ Outperform; to be awarded a big gov. contract - RBC Capital
January 28, 2010 8:43 AM EST
From Notable Calls
RBC Capital is picking up coverage on SIGA Technologies (NASDAQ: SIGA) with Outperform rating and $11 price target, while noting that depending on contract size SIGA's NPV could be as high as $26/per share.
Firm notes their positive thesis is based on the likelihood that SIGA Technologies, Inc. will be awarded a lucrative contract under Project BioShield to supply the U.S. Government with its oral treatment for smallpox (ST-246, tecovirimat). SIGA shares traded lower following an unexpected amendment to the Request for Proposals (RFP), which they believe creates an attractive entry point. The timing of a contract is uncertain but is likely to occur in the firsthalf 2010. The recent negative assessment of the U.S. Government’s preparedness also increases political pressure to get a contract signed, in RBC's opinion. The simple oral dosing, compelling animal data, anecdotal efficacy in humans against related viral infections, and secure and audited supply chain make ST-246 an attractive asset to the U.S. Government and others interested in effective counter measures against smallpox.
Key Reasons to Expect BARDA Contract
- Small pox counter measures are a high priority at Biomedical Advanced Research and Development Authority (BARDA) given the vulnerability of the population following the discontinuation of routine vaccination in 1972.
- Only two known drugs are vying for the government contract, and the amended RFP permits the government to acquire both.
- ST-246 has demonstrated safety in humans and efficacy across multiple animal species, including non-human primates.
- This week a bipartisan commission issued a scathing report giving the U.S. Government an “F” for preparedness, increasing the political pressure for the government to act now.
Initial Contract worth Approximately $500 million; Expansion Potential to over $1 billion
- Assuming $250-300 per course of treatment and an initial contract for 1.7 million courses, the total sale could be $425-510 million over a three-year period.
- The initial contract has an option to expand to 12 million courses (a blockbuster opportunity even if price is adjusted downward for the increased volume).
- Other governments are likely to place orders after the United States
Competition – Room for Two Drugs
- Privately held Chimerix Inc. is developing a competitive agent for the treatment of smallpox. Because Chimerix is private, there are limited public disclosures regarding the status of its program.
- CMX001 is Chimerix’s oral version of the broadly active antiviral cidofovir. It is active in most animal models of smallpox but cannot be tested in non-human primates, which may provide a competitive advantage for SIGA because the RFP requires that the company demonstrates efficacy in non-human primates.
Governmental Purchasing and Regulation are the Key Risks
SIGA is seeking government contracts for ST-246. As a result, SIGA is dependent on the vagaries of timing, purchase size and pricing. The U.S. Government could also change its mind or amend the contract. In addition, gaining FDA approval will require SIGA to use the ‘animal rule’ because efficacy studies in humans are not possible with smallpox. Although there are guidelines for approval based on animal studies, the path is not well trodden, and there remains significant regulatory risk. FDA approval is not necessary for initial government purchases, but it may be required for longer-term contracts or sales in other countries.
Government Funding History Suggests Strong Interest in ST-246
Over the past-two years, SIGA has received contracts and grants totalling $78 million specifically for the development of ST-246. This amount includes a $55 million contract to develop alternative intravenous formulations of ST-246 for seriously ill patients and a $20 million extension to a $16.5 million, 2006, three-year contract for the development of ST-246. Given the government’s investment in this program, and the advanced stage of clinical and regulatory development of the program, we believe a contract to purchase ST-246 for the Strategic National Stockpile (SNS) is highly likely.
Notablecalls: SIGA Tech (SIGA) certainly presents an interesting situation for traders here as RBC Capital seems to be the 1st firm to pick up coverage on this biodefense name. Biodefense (and homeland def. in general) has become a hit topic once again & contracts usually follow.
Note that SIGA has a long history getting funding from the U.S. Government. Since 2004, SIGA has secured approximately $122 million in government grants, contracts and awards to fund the development of ST-246 and other novel antiviral agents.
I really don't think the Government will leave SIGA empty-handed after plowing $100m+ into the co.
As noted, RBC estimates the stock could be worth up to $26 if everything goes right. That's some upside.
I think this call will get traders' attention and will serve to push the stock higher by 10%+, putting $7 level possibly in plays.
Fazit:
Bekanntlich ist an der Börse nichts sicher. Aber es gibt wahrscheinliche Szenarien und unwahrscheinliche. Das aufgezeigte Szenario gehört wohl zu den wahrscheinlichen. Der Eintritt ist zeitlich im 1. Halbjahr 2010 zu erwarten. Die Zeit spricht für Siga, da der Druck umso stärker wächst, je mehr Nachfrage nach ST-246 für Emergency Use eintritt, wie zuletzt von Israel:
"While no drug was actually delivered in this exercise, Israeli authorities told us they had arranged for immediate transportation of as many courses as we could provide, fully understanding that our drug candidate is under advanced development with BARDA and not registered with FDA," said Eric A. Rose, MD, SIGA's Chief Executive Officer.
http://investor.siga.com/releasedetail.cfm?ReleaseID=438564
In den nachfolgenden Beiträgen werde ich zu den einzelnen Werten ausführen, auf welcher Grundlage meine Erwartungen der Kursziele Ende 2010 basieren:
Dialog Semiconductor: Kursziel Ende 2010 13 Euro!
Für 2009 erwarte ich bei Dialog ein EPS von 40 Eurocent und für 2010 von 60 Eurocent bei gut 300 Mill. Dollar Umsatz. Ein zugestandenes KGV von 20 am Ende des Jahres 2010 führt zum genannten Kursziel.
Eine Steigerung bereits in 2010 von 40 % könnte auch zu dem Schluß führen, bei Dialog Gewinne mitzunehmen, da das Potential bei bereits gesehenen Kursen > 11 Euro eher begrenzt ist, bei jetzt steigenden Risiken.
Wer die Prognosen von Dialog beobachtet weis, daß diese nach dem kaufmännischen Vorsichtsprinzip ausgesprochen werden, d.h. es ist
immer noch Luft nach oben. Entsprechend denke ich, werden am 11.02. bei Bekanntgabe der Jahreszahlen 2009, auch die Prognosen für 2010 lauten, "ein 2-stelliger Umsatzzuwachs bei überproportional steigendem Ergebnis."
Wer Dialog hinsichtlich der Veröffentlichungen verfolgt weis, daß die Produktpipeline prall gefüllt ist. An dieser Stelle will ich 3 Beispiele aufführen, die nicht in den 2010er und Folgejahren bisher enthalten sind:
a) Mirasol-Mems Launches für Mobiltelefone und E-Reader!
Qualcomm greift auf die PM-Lösungen von Dialog zurück. Für 2010 wird die "Massenproduktion" dieser Displaytechnologie erwartet. Weitergehende Infos unter:
http://www.mirasoldisplays.com/qualcomm-display-technology-n…
Man beachte die neuen Medienberichte 2010 zur CES z.b.
Exclusive: Tech Behind Next-Gen Kindle Revealed?
Zitat eines Qualcomm Spokesman:
"When pressed about who its partner might be in 2010, a company spokesman asked me, "You know that device that everyone reads books on? Well, it's going to be a game changer on a device we all know."
b) Dialog - Intel Kooperation = Nokia Design Wins für Dialog?
Im April 2009 kündigt Dialog eine Kooperation mit Intel an, für die nächste Generation von Atom Prozessoren mit PM Lösungen "Dialog Inside". Der Rollout der Lösungen in Mobiltelefonen für 2011 ist hier angekündigt. Die Chance für Intel in diesem Segment den Einstieg zu finden:
http://www.dialog-semiconductor.de/img/panoramas/pda7.jpg
Im Juni 2009 dann folgende Meldung von Intel und Nokia:
Intel und Nokia kooperieren bei Mobilgeräten
Die Intel-Kooperation könnte für Dialog erst der richtige Einstieg in den Massenmarkt bedeuten, in dem man für seine PM-Lösungen Nokia als Kunden gewinnt!
c)Neue PM-Oled Display Technologie Smartxtend vor dem Durchbruch?
Bereits vor längerer Zeit gab Dialog bekannt, mit der Smartxtend Technologie über eine neue Generation von Display-Generation zu verfügen, die Dialog in neue Umsatzdimensionen führen dürfte:
http://www.dialog-semiconductor.de/pr.php?pr=dialog-semicond…
Inzwischen konnte mit TDK einen führenden Kooperationspartner gewinnen. Desweiteren verweist man darauf, daß die Markteinführung sich im Zeitrahmen befindet. Demnach wird ist der Launch dieser Technologie für die 2. Jahreshälfte 2010 vorgesehen.
Auch die neueste Investorenpräsentation von Dialog aus Januar 2010 bestätigt diese Aussage auf der Seite 19:
"Oled Technology - Dialog is leading the shift to Ultra Low Power Celluar Displays with SmartXTend".
http://www.dialog-semiconductor.de/reports/Cheuvreux-Jan2010…
Fazit: Dialog präsentiert am 11.02. die Jahreszahlen 2009. Der Ausblick dürfte gewohnt konservativ ausfallen. Das Wachstum 2010 basiert primär auf ein wachsende Desin Wins mit Samsung, LG und Apple!
Vor solchen Ereignissen launched Dialog gerne Meldungen, die über den Fortschritt von Design Wins berichten. Dies kann dann der Türöffner für die erfolgreiche Umsetzung der Produktpipeline sein mit der Folge, daß meine Erwartungen hinsichtlich der Kursziele für Dialog überarbeitet werden müssen. Schafft es Dialog die vorgestellte Produktpipeline erfolgreich umzusetzen, sind aktuelle Kurse von 10-11 Euro, nach über 1000 % Kurszuwachs innerhalb der letzten 12 Monate, die Zwischenstaftion für weitere mittelfristige Wertzuwäschse auf über 20 Euro!
Dialog Semiconductor: Kursziel Ende 2010 13 Euro!
Für 2009 erwarte ich bei Dialog ein EPS von 40 Eurocent und für 2010 von 60 Eurocent bei gut 300 Mill. Dollar Umsatz. Ein zugestandenes KGV von 20 am Ende des Jahres 2010 führt zum genannten Kursziel.
Eine Steigerung bereits in 2010 von 40 % könnte auch zu dem Schluß führen, bei Dialog Gewinne mitzunehmen, da das Potential bei bereits gesehenen Kursen > 11 Euro eher begrenzt ist, bei jetzt steigenden Risiken.
Wer die Prognosen von Dialog beobachtet weis, daß diese nach dem kaufmännischen Vorsichtsprinzip ausgesprochen werden, d.h. es ist
immer noch Luft nach oben. Entsprechend denke ich, werden am 11.02. bei Bekanntgabe der Jahreszahlen 2009, auch die Prognosen für 2010 lauten, "ein 2-stelliger Umsatzzuwachs bei überproportional steigendem Ergebnis."
Wer Dialog hinsichtlich der Veröffentlichungen verfolgt weis, daß die Produktpipeline prall gefüllt ist. An dieser Stelle will ich 3 Beispiele aufführen, die nicht in den 2010er und Folgejahren bisher enthalten sind:
a) Mirasol-Mems Launches für Mobiltelefone und E-Reader!
Qualcomm greift auf die PM-Lösungen von Dialog zurück. Für 2010 wird die "Massenproduktion" dieser Displaytechnologie erwartet. Weitergehende Infos unter:
http://www.mirasoldisplays.com/qualcomm-display-technology-n…
Man beachte die neuen Medienberichte 2010 zur CES z.b.
Exclusive: Tech Behind Next-Gen Kindle Revealed?
Zitat eines Qualcomm Spokesman:
"When pressed about who its partner might be in 2010, a company spokesman asked me, "You know that device that everyone reads books on? Well, it's going to be a game changer on a device we all know."
b) Dialog - Intel Kooperation = Nokia Design Wins für Dialog?
Im April 2009 kündigt Dialog eine Kooperation mit Intel an, für die nächste Generation von Atom Prozessoren mit PM Lösungen "Dialog Inside". Der Rollout der Lösungen in Mobiltelefonen für 2011 ist hier angekündigt. Die Chance für Intel in diesem Segment den Einstieg zu finden:
http://www.dialog-semiconductor.de/img/panoramas/pda7.jpg
Im Juni 2009 dann folgende Meldung von Intel und Nokia:
Intel und Nokia kooperieren bei Mobilgeräten
Die Intel-Kooperation könnte für Dialog erst der richtige Einstieg in den Massenmarkt bedeuten, in dem man für seine PM-Lösungen Nokia als Kunden gewinnt!
c)Neue PM-Oled Display Technologie Smartxtend vor dem Durchbruch?
Bereits vor längerer Zeit gab Dialog bekannt, mit der Smartxtend Technologie über eine neue Generation von Display-Generation zu verfügen, die Dialog in neue Umsatzdimensionen führen dürfte:
http://www.dialog-semiconductor.de/pr.php?pr=dialog-semicond…
Inzwischen konnte mit TDK einen führenden Kooperationspartner gewinnen. Desweiteren verweist man darauf, daß die Markteinführung sich im Zeitrahmen befindet. Demnach wird ist der Launch dieser Technologie für die 2. Jahreshälfte 2010 vorgesehen.
Auch die neueste Investorenpräsentation von Dialog aus Januar 2010 bestätigt diese Aussage auf der Seite 19:
"Oled Technology - Dialog is leading the shift to Ultra Low Power Celluar Displays with SmartXTend".
http://www.dialog-semiconductor.de/reports/Cheuvreux-Jan2010…
Fazit: Dialog präsentiert am 11.02. die Jahreszahlen 2009. Der Ausblick dürfte gewohnt konservativ ausfallen. Das Wachstum 2010 basiert primär auf ein wachsende Desin Wins mit Samsung, LG und Apple!
Vor solchen Ereignissen launched Dialog gerne Meldungen, die über den Fortschritt von Design Wins berichten. Dies kann dann der Türöffner für die erfolgreiche Umsetzung der Produktpipeline sein mit der Folge, daß meine Erwartungen hinsichtlich der Kursziele für Dialog überarbeitet werden müssen. Schafft es Dialog die vorgestellte Produktpipeline erfolgreich umzusetzen, sind aktuelle Kurse von 10-11 Euro, nach über 1000 % Kurszuwachs innerhalb der letzten 12 Monate, die Zwischenstaftion für weitere mittelfristige Wertzuwäschse auf über 20 Euro!
Antwort auf Beitrag Nr.: 38.789.381 von Kleiner Chef am 22.01.10 11:11:36Aktueller Depotstatus und Ausblick: Depotperformance in 2010 knapp 30 %!
Dialog Semiconductor
Kurs Anfang 2010 7,60 Euro
Kurs Aktuell 10,9 Euro
Kurserwartung Ende 2010 13 Euro
Siga Technology:
Kurs Anfang 2010 3,8 Euro
Kurs Aktuell 4,05 Euro
Kurserwartung Ende 2010 15 Euro
Billing Services Group
Kurs Anfang 2010 0,22 Euro
Kurs Aktuell 0,29 Euro
Kurserwartung Ende 2010 0,75 Euro
Nanostart AG
Kurs Anfang 2010 16,8 Euro
Kurs Aktuell 22,5 Euro
Kurserwartung Ende 2010 50 Euro
Nanofocus
Kurs Anfang 2010 4,75 Euro
Kurs Aktuell 4,20 Euro
Kurserwartung Ende 2010 8 Euro
Plan-Optik
Kurs Anfang 2010 2,6 Euro
Kurs Aktuell 4,00 Euro
Kurserwartung Ende 2010 5 Euro
Quanmax
Kurs Anfang 2010 1,7 Euro
Kurs Aktuell 1,7 Euro
Kurserwartung Ende 2010 4 Euro
Bavaria Industriekapital
Kurs Anfang 2010 9 Euro
Kurs Aktuell 11,75 Euro
Kurserwartung Ende 2010 20 Euro
Mox Telecom
Kaufkurs im Januar 6,4 Euro
Kurs aktuell 6,4 Euro
Kurserwartung Ende 2010 12 Euro
Labopharm
Kaufkurs im Januar 1,50 Euro
Kurs aktuell 1,7 Euro
Kurserwartung Ende 2010 4 Euro
Pacific Lottery
Kurs Anfang des Jahres 0,05 Euro
Kurs aktuell 0,05 Euro
Kurserwartung Ende 2010 - Euro
Brilliant Technology
Kurs Anfang des Jahres 0,03 Dollar
Kurs aktuell 0,03 Dollar
Kurserwartung Ende 2010 - Dollar
Fazit: Depotstart in 2010 ist geglückt. Perfomance 2010
bisher knapp 30 %, da Plan-Optik mit 50 % vorn, Dialog mit 40 % vorn, und Bavaria, Nanostart, Billing Services mit 35 % vorn.
Aktuelle Disposition
Verkauf Plan-Optik, da Konsolidierung erwartet wird und Gewinnmitnahe!
Dialog Semiconductor
Kurs Anfang 2010 7,60 Euro
Kurs Aktuell 10,9 Euro
Kurserwartung Ende 2010 13 Euro
Siga Technology:
Kurs Anfang 2010 3,8 Euro
Kurs Aktuell 4,05 Euro
Kurserwartung Ende 2010 15 Euro
Billing Services Group
Kurs Anfang 2010 0,22 Euro
Kurs Aktuell 0,29 Euro
Kurserwartung Ende 2010 0,75 Euro
Nanostart AG
Kurs Anfang 2010 16,8 Euro
Kurs Aktuell 22,5 Euro
Kurserwartung Ende 2010 50 Euro
Nanofocus
Kurs Anfang 2010 4,75 Euro
Kurs Aktuell 4,20 Euro
Kurserwartung Ende 2010 8 Euro
Plan-Optik
Kurs Anfang 2010 2,6 Euro
Kurs Aktuell 4,00 Euro
Kurserwartung Ende 2010 5 Euro
Quanmax
Kurs Anfang 2010 1,7 Euro
Kurs Aktuell 1,7 Euro
Kurserwartung Ende 2010 4 Euro
Bavaria Industriekapital
Kurs Anfang 2010 9 Euro
Kurs Aktuell 11,75 Euro
Kurserwartung Ende 2010 20 Euro
Mox Telecom
Kaufkurs im Januar 6,4 Euro
Kurs aktuell 6,4 Euro
Kurserwartung Ende 2010 12 Euro
Labopharm
Kaufkurs im Januar 1,50 Euro
Kurs aktuell 1,7 Euro
Kurserwartung Ende 2010 4 Euro
Pacific Lottery
Kurs Anfang des Jahres 0,05 Euro
Kurs aktuell 0,05 Euro
Kurserwartung Ende 2010 - Euro
Brilliant Technology
Kurs Anfang des Jahres 0,03 Dollar
Kurs aktuell 0,03 Dollar
Kurserwartung Ende 2010 - Dollar
Fazit: Depotstart in 2010 ist geglückt. Perfomance 2010
bisher knapp 30 %, da Plan-Optik mit 50 % vorn, Dialog mit 40 % vorn, und Bavaria, Nanostart, Billing Services mit 35 % vorn.
Aktuelle Disposition
Verkauf Plan-Optik, da Konsolidierung erwartet wird und Gewinnmitnahe!
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