CIPHER PHARMA am Abgrund? - 500 Beiträge pro Seite
eröffnet am 15.05.07 21:30:23 von
neuester Beitrag 14.05.09 19:34:03 von
neuester Beitrag 14.05.09 19:34:03 von
Beiträge: 44
ID: 1.127.432
ID: 1.127.432
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ISIN: CA17253X1050 · WKN: A0B85L · Symbol: CPH
8,5000
CAD
0,00 %
0,0000 CAD
Letzter Kurs 26.04.24 Toronto
Werte aus der Branche Pharmaindustrie
Wertpapier | Kurs | Perf. % |
---|---|---|
0,9000 | +305,04 | |
57,10 | +40,50 | |
16,740 | +31,50 | |
0,6500 | +25,75 | |
1,8700 | +21,43 |
Wertpapier | Kurs | Perf. % |
---|---|---|
4,0200 | -10,77 | |
6,3150 | -13,02 | |
23,000 | -16,97 | |
1,2100 | -17,12 | |
2,7280 | -29,14 |
Zur Zeit in einigen Turbulenzen, aber es dürften auf Jahressicht wieder bessere Zeiten kommen.
http://finance.google.com/finance?q=TSE%3ADND
http://www.eyeonfda.com/eye_on_fda/2007/05/approvable_lett.h…
FORT WORTH, TX, May 8 /CNW/ - Corriente Advisors L.L.C., the general partner of Corriente Master Fund, L.P., announced today that on April 27, 2007 Corriente Master Fund, L.P. acquired beneficial ownership of 301,100 common shares (the "Shares") of Cipher Pharmaceuticals Inc. ("Cipher"). The Shares acquired on April 27, 2007 represent approximately 1.3% of the 24,035,601 issued and outstanding Shares as at April 30, 2007.
http://www.newswire.ca/en/releases/archive/May2007/08/c6371.…
°°°°°°°°°°°°°°°°°°°°°°°^
esco7
http://finance.google.com/finance?q=TSE%3ADND
http://www.eyeonfda.com/eye_on_fda/2007/05/approvable_lett.h…
FORT WORTH, TX, May 8 /CNW/ - Corriente Advisors L.L.C., the general partner of Corriente Master Fund, L.P., announced today that on April 27, 2007 Corriente Master Fund, L.P. acquired beneficial ownership of 301,100 common shares (the "Shares") of Cipher Pharmaceuticals Inc. ("Cipher"). The Shares acquired on April 27, 2007 represent approximately 1.3% of the 24,035,601 issued and outstanding Shares as at April 30, 2007.
http://www.newswire.ca/en/releases/archive/May2007/08/c6371.…
°°°°°°°°°°°°°°°°°°°°°°°^
esco7
Antwort auf Beitrag Nr.: 29.333.711 von esco7 am 15.05.07 21:30:23 Hallo, jemand da?
Ich finde das man bei diesem Stand auf jeden Fall einsteigen kann.
Wer hat genauere Infos zur aktuellen Lage?
In Can ist sie ja leicht hoch gegangen gegenüber Deu
Ich auf jeden Fall bin jetzt Invest & bleibe auch long....
Gruß SuZau
Ich finde das man bei diesem Stand auf jeden Fall einsteigen kann.
Wer hat genauere Infos zur aktuellen Lage?
In Can ist sie ja leicht hoch gegangen gegenüber Deu
Ich auf jeden Fall bin jetzt Invest & bleibe auch long....
Gruß SuZau
Antwort auf Beitrag Nr.: 30.895.854 von superzausel am 28.07.07 15:44:43Willkommen auf dem einsamen Außenposten von
Cipher Pharma. Wenn du hier zu Besuch bist, ist das symbolisch gesehen so ähnlich wie auf (Sorry; ich liebe Symbole):
http://www.amapof.com/articles.php?id=1191
Kerguelen; Karte
http://www.kerguelen.de/KerguelenFrames/FramesetKerguelen.ht…
Linkliste
Informationen ??? Nein; dort ist niemand aus meiner Verwandtschaft beschäftigt.
Wir warten auf das nächste „Postschiff“…..
Zu einem gemeinsamen Kaffee bist du immer eingeladen.
esco7
Cipher Pharma. Wenn du hier zu Besuch bist, ist das symbolisch gesehen so ähnlich wie auf (Sorry; ich liebe Symbole):
http://www.amapof.com/articles.php?id=1191
Kerguelen; Karte
http://www.kerguelen.de/KerguelenFrames/FramesetKerguelen.ht…
Linkliste
Informationen ??? Nein; dort ist niemand aus meiner Verwandtschaft beschäftigt.
Wir warten auf das nächste „Postschiff“…..
Zu einem gemeinsamen Kaffee bist du immer eingeladen.
esco7
Financial Review
----------------
In the first quarter of 2008, Cipher recorded total revenue of $177,000, compared with nil in the same period last year. Research and de-velopment (R&D) expenses decreased from $0.7 million in the first quarter of fiscal 2007 to $0.3 million in the first quarter of 2008, reflecting the advanced stage of development of the Company's current products. Operating, general and administrative (OG&A) expenses for the first quarter of 2008 were $1.0 million, compared with $1.1 million in the same period last year. While Cipher expects to add select resources to the management team this year to support continued growth, the Company's fixed operating costs will be partially offset by revenue from Lipofen. Net loss for the three months ended March 31, 2008 was $1.1 million ($0.04 per basic and diluted share), compared with a net loss of $1.7 million ($0.07 per basic and diluted share) in the same period last year.
As at March 31, 2008, Cipher had cash of $10.3 million, compared with
$11.0 million at December 31, 2007.
Drug Development Update
-----------------------
In July 2007, Cipher entered into a licensing and distribution agree-ment with ProEthic Pharmaceuticals under which ProEthic was granted the ex-clusive right to market, sell and distribute Lipofen in the United States. In late September 2007, ProEthic launched Lipofen 150 mg and 50 mg capsules in the U.S. market with the full effort of its sales and marketing teams. Lipofen is the lead product for ProEthic as it seeks to build its presence in the important primary care space. Since the product was launched, weekly prescriptions have shown steady growth and the Company is encouraged by the progress to date.
http://www.newswire.ca/en/releases/archive/May2008/01/c3431.…
Weiterhin kleine Brötchen bei Börsenvolumen und Produktumsatz.
esco7
----------------
In the first quarter of 2008, Cipher recorded total revenue of $177,000, compared with nil in the same period last year. Research and de-velopment (R&D) expenses decreased from $0.7 million in the first quarter of fiscal 2007 to $0.3 million in the first quarter of 2008, reflecting the advanced stage of development of the Company's current products. Operating, general and administrative (OG&A) expenses for the first quarter of 2008 were $1.0 million, compared with $1.1 million in the same period last year. While Cipher expects to add select resources to the management team this year to support continued growth, the Company's fixed operating costs will be partially offset by revenue from Lipofen. Net loss for the three months ended March 31, 2008 was $1.1 million ($0.04 per basic and diluted share), compared with a net loss of $1.7 million ($0.07 per basic and diluted share) in the same period last year.
As at March 31, 2008, Cipher had cash of $10.3 million, compared with
$11.0 million at December 31, 2007.
Drug Development Update
-----------------------
In July 2007, Cipher entered into a licensing and distribution agree-ment with ProEthic Pharmaceuticals under which ProEthic was granted the ex-clusive right to market, sell and distribute Lipofen in the United States. In late September 2007, ProEthic launched Lipofen 150 mg and 50 mg capsules in the U.S. market with the full effort of its sales and marketing teams. Lipofen is the lead product for ProEthic as it seeks to build its presence in the important primary care space. Since the product was launched, weekly prescriptions have shown steady growth and the Company is encouraged by the progress to date.
http://www.newswire.ca/en/releases/archive/May2008/01/c3431.…
Weiterhin kleine Brötchen bei Börsenvolumen und Produktumsatz.
esco7
8/13/2008 1:15 PM ET
(RTTNews) - Wednesday, drug development company Cipher Pharmaceuticals Inc. (DND.TO: News, Chart, Quote ) reported a narrower loss for the second quarter, helped by a 22% increase in revenue.
Commenting on the quarter, Larry Andrews, President and chief executive officer, said, "A key product develop-ment highlight during the quarter was the submission of our revised NDA for extended-release tramadol, which we believe provides the most expeditious path to final regulatory approval."
For the first half of 2008, net loss narrowed to C$2.9 million or C$0.12 per share from C$3.8 million or C$0.16 per share in the previous year period.
Total revenue for the year-to-date period grew to C$454,000 from C$227,000 in the preceding year period.
°°°°°
Gääähn…..
(RTTNews) - Wednesday, drug development company Cipher Pharmaceuticals Inc. (DND.TO: News, Chart, Quote ) reported a narrower loss for the second quarter, helped by a 22% increase in revenue.
Commenting on the quarter, Larry Andrews, President and chief executive officer, said, "A key product develop-ment highlight during the quarter was the submission of our revised NDA for extended-release tramadol, which we believe provides the most expeditious path to final regulatory approval."
For the first half of 2008, net loss narrowed to C$2.9 million or C$0.12 per share from C$3.8 million or C$0.16 per share in the previous year period.
Total revenue for the year-to-date period grew to C$454,000 from C$227,000 in the preceding year period.
°°°°°
Gääähn…..
Ich glaube jetzt geht es endlich aufwärts!
Viel Glück an alle
Viel Glück an alle
......und wo bleiben die umsätze????
Die werden ja kaum gehandelt
Greez
Die werden ja kaum gehandelt
Greez
Antwort auf Beitrag Nr.: 36.366.843 von sacha1978 am 13.01.09 20:23:20......und wo bleiben die umsätze????
Schon mal was von "Low Float" gehört ? Wie ich schon erwähnt habe es befinden sich nur sehr wenige Aktien im Umlauf .
Ok bisher habe ich nur im Labopharm Thread über Cipher gepostet , aber ab jetzt nur hier .
Der titel " Cipher Pharma am Abgrund" hat zu damaligen Zeit gut gepasst ,aber jetzt schaut Cipher vom Abgrund nach oben .
Schon mal was von "Low Float" gehört ? Wie ich schon erwähnt habe es befinden sich nur sehr wenige Aktien im Umlauf .
Ok bisher habe ich nur im Labopharm Thread über Cipher gepostet , aber ab jetzt nur hier .
Der titel " Cipher Pharma am Abgrund" hat zu damaligen Zeit gut gepasst ,aber jetzt schaut Cipher vom Abgrund nach oben .
Gestern wurde mit lediglich 500st. Cipher um 17% nach oben katapultiert .
Cipher Pharma (DND.TO)
Marktkap: 17 million CDN$ ( 10,5 million €)
Cash: 10,3 million CDN$ ( 5,9 million € )
Kurs : 0,71 C$
1. Cashbestand wurde zum Vorquartal um 400tsd C$ auf 10,3 mio C$ gesteigert
2. Cipher hat keine Schulden
3. Cipher hat so gut wie keine Ausgaben da sich Lipofen bereits auf dem Markt befindet,Tramadol nur noch auf die Zulassung wartet und Isotretinoin von Ranbaxy Pharma zum teil finanziert wird .
Pipeline
Insiderhandel
http://canadianinsider.com/coReport/allTransactions.php?tick…
Larry Andrews (CEO) hält ca. 9,7 million Aktien
Corriente Master Fund ca. 5 millionen Aktien
Lipofen << Wie ihr auf den Chart seht steigt die Anzahl der Verschreibungen
Isotretinoin << Best in Class potential Zulassung noch in 2009 möglich
Tramadol << Zulassung kann jeden Tag soweit sein
Cipher Pharma (DND.TO)
Marktkap: 17 million CDN$ ( 10,5 million €)
Cash: 10,3 million CDN$ ( 5,9 million € )
Kurs : 0,71 C$
1. Cashbestand wurde zum Vorquartal um 400tsd C$ auf 10,3 mio C$ gesteigert
2. Cipher hat keine Schulden
3. Cipher hat so gut wie keine Ausgaben da sich Lipofen bereits auf dem Markt befindet,Tramadol nur noch auf die Zulassung wartet und Isotretinoin von Ranbaxy Pharma zum teil finanziert wird .
Pipeline
Insiderhandel
http://canadianinsider.com/coReport/allTransactions.php?tick…
Larry Andrews (CEO) hält ca. 9,7 million Aktien
Corriente Master Fund ca. 5 millionen Aktien
Lipofen << Wie ihr auf den Chart seht steigt die Anzahl der Verschreibungen
Isotretinoin << Best in Class potential Zulassung noch in 2009 möglich
Tramadol << Zulassung kann jeden Tag soweit sein
Antwort auf Beitrag Nr.: 36.369.008 von StaatsKnecht am 14.01.09 09:47:25Im Ask befinden sich wieder nur 500st. für 0,76$ also man kommt nicht an viele Aktien ohne den Kurs explodieren zulassen....
http://www.stockhouse.com/tools/?page=%2FFinancialTools%2Fsn…
http://www.stockhouse.com/tools/?page=%2FFinancialTools%2Fsn…
Hier nur als beispiel wie daneben Global Biotech Investing damals gelegen haben . GBI hat die Aktie empfohlen da war der Kurs bei 4,30 € !!!!!!!!!!! 6-Feb-06 4.32 4.35 4.30 4.34 80,300 4.34 http://finance.yahoo.com/q/hp?s=DND.TO&a=00&b=7&c=2006&d=02&…
Jetzt steht die Aktie besser da als je zuvor und wird nicht empfohlen
Cipher Pharmaceuticals für Spekulative
06.02.2006
Global Biotech Investing
Spekulative Anleger springen umgehend mit einer kleinen Startposition auf die Cipher Pharmaceuticals-Aktie (ISIN CA17253X1050 / WKN A0B85L) auf, im deutschen Handel aber unbedingt limitieren, raten die Experten von "Global Biotech Investing".
Das Unternehmen habe Mitte Januar die endgültige Vertriebsfreigabe für den Cholesterin-Senker Lipofen von den US-Gesundheitsbehörden erhalten. Dies sei das erste Präparat, welches die Gesellschaft auf dem Markt habe. Als nächstes wolle Cipher Pharmaceuticals nun so schnell wie möglich eine Vertriebsvereinbarung eingehen.
Mit CIP-Isotretinion und CIP-Tramadol habe die Gesellschaft noch zwei weitere interessante Mittel in der Produktpipeline. Für CIP-Isotretinion werde ein FDA-Entscheid spätestens bis zum 01. Mai erwartet.
Das Investmenthaus Clarus Securities prognostiziere im kommenden Jahr ein EPS in Höhe von 0,60 Kanadische Dollar. Damit wäre der Titel - trotz der jüngsten Kursrally - lediglich mit einem KGV 2007e von 9 bewertet.
Spekulative Anleger springen umgehend mit einer kleinen Startposition auf die Cipher Pharmaceuticals-Aktie auf, im deutschen Handel aber unbedingt limitieren, raten die Experten von "Global Biotech Investing".
Jetzt steht die Aktie besser da als je zuvor und wird nicht empfohlen
Cipher Pharmaceuticals für Spekulative
06.02.2006
Global Biotech Investing
Spekulative Anleger springen umgehend mit einer kleinen Startposition auf die Cipher Pharmaceuticals-Aktie (ISIN CA17253X1050 / WKN A0B85L) auf, im deutschen Handel aber unbedingt limitieren, raten die Experten von "Global Biotech Investing".
Das Unternehmen habe Mitte Januar die endgültige Vertriebsfreigabe für den Cholesterin-Senker Lipofen von den US-Gesundheitsbehörden erhalten. Dies sei das erste Präparat, welches die Gesellschaft auf dem Markt habe. Als nächstes wolle Cipher Pharmaceuticals nun so schnell wie möglich eine Vertriebsvereinbarung eingehen.
Mit CIP-Isotretinion und CIP-Tramadol habe die Gesellschaft noch zwei weitere interessante Mittel in der Produktpipeline. Für CIP-Isotretinion werde ein FDA-Entscheid spätestens bis zum 01. Mai erwartet.
Das Investmenthaus Clarus Securities prognostiziere im kommenden Jahr ein EPS in Höhe von 0,60 Kanadische Dollar. Damit wäre der Titel - trotz der jüngsten Kursrally - lediglich mit einem KGV 2007e von 9 bewertet.
Spekulative Anleger springen umgehend mit einer kleinen Startposition auf die Cipher Pharmaceuticals-Aktie auf, im deutschen Handel aber unbedingt limitieren, raten die Experten von "Global Biotech Investing".
Antwort auf Beitrag Nr.: 36.369.218 von StaatsKnecht am 14.01.09 10:10:44Für Isotretinoin hätte man keinen besseren Partner finden können die Inder sind wirklich sehr erfolgreich .
Hoffentlich gehts bald über die rote Linie obwohl der Chart bei solchen kleinen werten keine große rolle spielt .
Und wieder 13% aufwärts mit weniger als 2000stück ...
Corriente Fund versucht den Kurs zu manipulieren aber sobald einer kaufen möchte ziehen die ihre anteile aus dem Ask zurück .
Ich denke Cipher wird abgehen wie SQNM oder QCOR suchts euch aus .
http://finance.yahoo.com/q?s=dnd.to&x=0&y=0
Corriente Fund versucht den Kurs zu manipulieren aber sobald einer kaufen möchte ziehen die ihre anteile aus dem Ask zurück .
Ich denke Cipher wird abgehen wie SQNM oder QCOR suchts euch aus .
http://finance.yahoo.com/q?s=dnd.to&x=0&y=0
Die grüne Schrift wird von Tag zu Tag immer mehr ,ich wusste aber vorher schon das Cipher ein 100%iger Buy ist ...
http://quote.barchart.com/texpert.asp?sym=dnd.to&code=BSTK
http://quote.barchart.com/texpert.asp?sym=dnd.to&code=BSTK
echat stein schalosch ... so das hast du jetzt davon
so jetzt sind wir quitt
asics
so jetzt sind wir quitt
asics
Antwort auf Beitrag Nr.: 36.375.488 von asics01 am 14.01.09 19:50:44asics im falle von Cipher beudetet das "echat stein schalosch = ich werde steinreich"
Meine Taschen werden auch bald so grinsen
Meine Taschen werden auch bald so grinsen
Antwort auf Beitrag Nr.: 36.375.613 von StaatsKnecht am 14.01.09 20:03:34Antara von Oscient ist ein direkter konkurrent von Lipofen hier könnt ihr schön sehen wie der Umsatz steigt .
Antara ist lediglich ein paar monate länger schon erhältlich .
Revenue from the cardiovascular drug ANTARA® (fenofibrate) capsules increased 41% to $18.1 million in the third quarter of 2008, from $12.8 million in the third quarter of 2007
http://biz.yahoo.com/bw/081104/20081104005584.html?.v=1
Antara ist lediglich ein paar monate länger schon erhältlich .
Revenue from the cardiovascular drug ANTARA® (fenofibrate) capsules increased 41% to $18.1 million in the third quarter of 2008, from $12.8 million in the third quarter of 2007
http://biz.yahoo.com/bw/081104/20081104005584.html?.v=1
Da will unbedingt einer 1000stück haben der erhöht cent für cent anstatt gleich für 0,88 zu kaufen .Wie geizig manche doch sind
Cipher Pharma (DND.TO)
Marktkap: 17 million CDN$ ( 10,5 million €) << wäre es übertrieben zu behaupten ,das verzehnfachung möglich ist ? Ich sage nein
Cash: 10,3 million CDN$ ( 5,9 million € )
Kurs : 0,71 C$
Warum kauft ein CEO(Larry Andrews) weitere Aktien wenn er doch schon über 9,7 milllion Aktien besitzt ?Also dumm ist er ganz sicher nicht . Schaut wo er schon überall war ..
"His career includes senior management assignments with Eli Lilly, Syntex Pharmaceuticals, and Hoffmann-La Roche. He received his Honors BSc degree from Memorial University before joining the pharmaceutical industry."
http://canadianinsider.com/coReport/allTransactions.php?tick…
Marktkap: 17 million CDN$ ( 10,5 million €) << wäre es übertrieben zu behaupten ,das verzehnfachung möglich ist ? Ich sage nein
Cash: 10,3 million CDN$ ( 5,9 million € )
Kurs : 0,71 C$
Warum kauft ein CEO(Larry Andrews) weitere Aktien wenn er doch schon über 9,7 milllion Aktien besitzt ?Also dumm ist er ganz sicher nicht . Schaut wo er schon überall war ..
"His career includes senior management assignments with Eli Lilly, Syntex Pharmaceuticals, and Hoffmann-La Roche. He received his Honors BSc degree from Memorial University before joining the pharmaceutical industry."
http://canadianinsider.com/coReport/allTransactions.php?tick…
Antwort auf Beitrag Nr.: 36.376.276 von StaatsKnecht am 14.01.09 21:10:18Hallo staatsknecht
Liegt man nicht schlecht wenn man sich in Toronto ein paar stk reinziehen möchte oder??
Danke für den tipp
greez
Liegt man nicht schlecht wenn man sich in Toronto ein paar stk reinziehen möchte oder??
Danke für den tipp
greez
Antwort auf Beitrag Nr.: 36.376.326 von sacha1978 am 14.01.09 21:15:57Es kommt drauf an bei welcher Bank du bist sind die gebühren niedrig lohnt sich das , und sehr wichtig limit auf keinenfall vergessen .
Vergiss nicht auch bei Cipher gibts gewisse RISIKEN !!!!!
Vergiss nicht auch bei Cipher gibts gewisse RISIKEN !!!!!
Die Kanadier interessieren sich kaum für Biotechs die sind viel mehr auf Explorer-Rohstoffaktien fixiert .Das ist manchmal auch gut so
Jetzt schon knapp 20% .....
Jetzt schon knapp 20% .....
Antwort auf Beitrag Nr.: 36.376.455 von StaatsKnecht am 14.01.09 21:30:01Danke dir!!
...ein gewisses Risiko gibts ja bekanntlich bei jedem Invest!!
Ich werde mal (bescheiden)mit ca 3T stk einsteigen....bleibt nur zu hoffen das ich diese auch bekomme!!!!!!
...und wünsche uns viel viel Glück!!
Greez
...ein gewisses Risiko gibts ja bekanntlich bei jedem Invest!!
Ich werde mal (bescheiden)mit ca 3T stk einsteigen....bleibt nur zu hoffen das ich diese auch bekomme!!!!!!
...und wünsche uns viel viel Glück!!
Greez
Antwort auf Beitrag Nr.: 36.376.553 von sacha1978 am 14.01.09 21:42:22Ich wünsche Dir viel erfolg und hoffe das du sehr viel verdienst .
Hab ein gebet ausgesprochen auf das uns jegliche art von unheil fern bleibt .
Hab ein gebet ausgesprochen auf das uns jegliche art von unheil fern bleibt .
Antwort auf Beitrag Nr.: 36.376.684 von StaatsKnecht am 14.01.09 21:56:40Danke das wünsche ich dir natürlich auch!!!!!
Ich hoffe sehr, dass wir bald solche Augen machen werden....
..solch ein gebet habe ich auch gerade eben ausgesprochen!
Greez
Ich hoffe sehr, dass wir bald solche Augen machen werden....
..solch ein gebet habe ich auch gerade eben ausgesprochen!
Greez
Antwort auf Beitrag Nr.: 36.376.748 von sacha1978 am 14.01.09 22:04:37Cipher belegt heute Platz 2 unter den Tagesgewinnern im Pharmasektor ...
Morgen gehts weiter bis dahin gute Nacht ....
Morgen gehts weiter bis dahin gute Nacht ....
Werde nachher mal Cipher in einigen Kanadischen Boards "promoten" ...
Die rote Linie kommt immer näher
Die rote Linie kommt immer näher
Antwort auf Beitrag Nr.: 36.378.556 von StaatsKnecht am 15.01.09 10:11:35Was hat den Bid/Ask so hoch getrieben ? hmm
http://aktiencheck.de/kurse/einzelkurse.m?MarketCode=FSE&Sym…
http://aktiencheck.de/kurse/einzelkurse.m?MarketCode=FSE&Sym…
Antwort auf Beitrag Nr.: 36.379.558 von StaatsKnecht am 15.01.09 11:55:21Bis jetzt ist noch nichts passiert ,ist ja noch früh bei denen dadrüben .
Cipher erinnert mich einwenig an Acorda Therapeutics ,ich war der erste der hier in Deutschland gekauft hat, weil ich von der Aktie auch überzeugt war leider habe ich die 3000st. schon bei 11€ verkauft (kk zwischen 2,60€ -3,20€).
Der erste hier in Deutschland war ich auch bei YM Bioscience(YMI), Javelin Pharma (JAV),Halozyme(HALO) usw ...ja das waren noch zeiten .
ACOR ist damals richtig abgegangen ...
Cipher erinnert mich einwenig an Acorda Therapeutics ,ich war der erste der hier in Deutschland gekauft hat, weil ich von der Aktie auch überzeugt war leider habe ich die 3000st. schon bei 11€ verkauft (kk zwischen 2,60€ -3,20€).
Der erste hier in Deutschland war ich auch bei YM Bioscience(YMI), Javelin Pharma (JAV),Halozyme(HALO) usw ...ja das waren noch zeiten .
ACOR ist damals richtig abgegangen ...
Nein nicht erschrecken Zulassung ist noch nicht da ,will nur die Daten unter "neuster Beitrag" haben .
Cipher Pharma (DND.TO)
Marktkap: 17 million CDN$ ( 10,5 million €)
Cash: 10,3 million CDN$ ( 5,9 million € )
Kurs : 0,85 C$
Für Isotretinoin hätte man keinen besseren Partner finden können die Inder sind wirklich sehr erfolgreich .
Pipeline
Insiderhandel
http://canadianinsider.com/coReport/allTransactions.php?tick…
Larry Andrews (CEO) hält ca. 9,7 million Aktien
Corriente Master Fund ca. 5 millionen Aktien
Lipofen << Wie ihr auf den Chart seht steigt die Anzahl der Verschreibungen
Isotretinoin << Best in Class potential Zulassung noch in 2009 möglich
Tramadol << Zulassung kann jeden Tag soweit sein
Cipher Pharma (DND.TO)
Marktkap: 17 million CDN$ ( 10,5 million €)
Cash: 10,3 million CDN$ ( 5,9 million € )
Kurs : 0,85 C$
Für Isotretinoin hätte man keinen besseren Partner finden können die Inder sind wirklich sehr erfolgreich .
Pipeline
Insiderhandel
http://canadianinsider.com/coReport/allTransactions.php?tick…
Larry Andrews (CEO) hält ca. 9,7 million Aktien
Corriente Master Fund ca. 5 millionen Aktien
Lipofen << Wie ihr auf den Chart seht steigt die Anzahl der Verschreibungen
Isotretinoin << Best in Class potential Zulassung noch in 2009 möglich
Tramadol << Zulassung kann jeden Tag soweit sein
Antwort auf Beitrag Nr.: 36.383.239 von StaatsKnecht am 15.01.09 18:30:38In ca 3 Wochen gibts Quartalszahlen und hoffentlich eine kleine Überraschung beim Umsatz von Lipofen .
Ich hoffe das die Zulassung für Tramadol vorher noch kommt .
Seit anfang Januar hat sich Cipher fast verdoppelt,auch wenn kaum Umsatz vorhanden ist .Ich hoffe das die irgendwann an die Nasdaq gehen wie es Labopharm vorgemacht hat .
Ich hoffe das die Zulassung für Tramadol vorher noch kommt .
Seit anfang Januar hat sich Cipher fast verdoppelt,auch wenn kaum Umsatz vorhanden ist .Ich hoffe das die irgendwann an die Nasdaq gehen wie es Labopharm vorgemacht hat .
Antwort auf Beitrag Nr.: 36.396.376 von StaatsKnecht am 17.01.09 19:35:32hallo staatsknecht
was ist denn tramadol (nach erfolgter zulassung????)wert
asics
was ist denn tramadol (nach erfolgter zulassung????)wert
asics
Antwort auf Beitrag Nr.: 36.397.263 von asics01 am 18.01.09 10:18:44Hi asics
Ich schätze mal so 30-50 millionen US$ sollten für Cipher im Jahr drin sein das scheint wenig zu sein aber für eine Cipher mit einer Marktkap von nur 12 million US$ ist das viel .
Dazu kommt noch der Umsatz von Lipofen man darf nicht vergessen das Lipofen erst seit einigen Monaten auf dem Markt erhältlich ist und dessen potential noch lange nicht ausgereizt ist .
Das Hauptprodukt wird jedoch Isotretinoin sein wenn alles gut geht dürfte ende 2009 spätestens anfang 2010 es in USA erhältlich sein .
Ich schätze mal so 30-50 millionen US$ sollten für Cipher im Jahr drin sein das scheint wenig zu sein aber für eine Cipher mit einer Marktkap von nur 12 million US$ ist das viel .
Dazu kommt noch der Umsatz von Lipofen man darf nicht vergessen das Lipofen erst seit einigen Monaten auf dem Markt erhältlich ist und dessen potential noch lange nicht ausgereizt ist .
Das Hauptprodukt wird jedoch Isotretinoin sein wenn alles gut geht dürfte ende 2009 spätestens anfang 2010 es in USA erhältlich sein .
Antwort auf Beitrag Nr.: 36.398.258 von StaatsKnecht am 18.01.09 15:01:35Ich hatte noch vergessen zu erwähnen das die 12 millionUS$ Marktkap durch ca. 9 million US$ Eigenkapital gedeckt sind .
Selbst wenn die null Umsatz machen würden (was nicht der fall ist)reicht das Geld für über 2 Jahre .
Selbst wenn die null Umsatz machen würden (was nicht der fall ist)reicht das Geld für über 2 Jahre .
Schon wieder steht Bid/Ask so hoch ...
http://aktiencheck.de/kurse/einzelkurse.m?MarketCode=FSE&Sym…
Ask ------Bid
0,91 € 0,83 €
http://aktiencheck.de/kurse/einzelkurse.m?MarketCode=FSE&Sym…
Ask ------Bid
0,91 € 0,83 €
Antwort auf Beitrag Nr.: 36.402.813 von StaatsKnecht am 19.01.09 13:44:35Cipher verhält sich ähnlich wie ein Auto ,sie fährt wenn es Grün ist und bei Rot bleibt sie einfach stehen .
Antwort auf Beitrag Nr.: 36.417.582 von StaatsKnecht am 21.01.09 11:50:45Nachricht kam nachbörslich na wenn das mal keine gute News sind . Tramadol ist so gut wie Zugelassen jetzt geht es nur noch um die Patentrechte .
Egal wie es ausgeht auch wenn Cipher im schlimmsten Falle mehrere monate auf die volle Zulassung warten muss ,wichtiger ist die müssen keine weiteren teueren Studien mehr volziehen .
Cipher ist bereits vor der Nachricht um 34% gestiegen ,die Aktie ist saubillig .
Cipher receives tentative FDA approval for extended-release tramadol capsules
2/17/2009 4:30 PM - Canada NewsWire
MISSISSAUGA, ON, Feb. 17, 2009 (Canada NewsWire via COMTEX News Network) --
Toronto Stock Exchange Symbol: DND
Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, the Company's extended-release formulation of the analgesic tramadol, which is indicated for the management of moderate to moderately severe chronic pain such as osteoarthritis. While the product meets all the FDA's requirements for manufacturing quality, clinical safety and efficacy, the Company must resolve certain patent issues related to the reference product, Ultram(R) ER, before CIP-TRAMADOL ER is commercialized.
"Tentative approval of our extended-release tramadol is another important achievement for our organization and validates the safety and efficacy of this product, which has an attractive profile for a chronic pain medication," said Larry Andrews, President and CEO of Cipher. "We are working diligently on the remaining steps toward commercialization, including securing a U.S. marketing partner and addressing the outstanding intellectual property issues."
Cipher's revised New Drug Application (NDA) for CIP-TRAMADOL ER was submitted in Q2 2008 as a 505(b)(2) application. Since there are issued U.S. patents for the approved product held by a third party, Cipher was required to certify to the FDA concerning any patents listed in the FDA's Orange Book publication at the time of submission. Cipher's application contained a paragraph III certification acknowledging that the listed patent had not expired and that final approval would be sought after patent expiration in 2014. A paragraph IV certification, which states that the listed patent is invalid, unenforceable, or will not be infringed by the manufacture or sale of the drug, may trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act. To date, this certification has not been filed.
CIP-TRAMADOL ER capsules are based on patented oral controlled-release bead technology and feature both immediate-release and extended-release properties.
Egal wie es ausgeht auch wenn Cipher im schlimmsten Falle mehrere monate auf die volle Zulassung warten muss ,wichtiger ist die müssen keine weiteren teueren Studien mehr volziehen .
Cipher ist bereits vor der Nachricht um 34% gestiegen ,die Aktie ist saubillig .
Cipher receives tentative FDA approval for extended-release tramadol capsules
2/17/2009 4:30 PM - Canada NewsWire
MISSISSAUGA, ON, Feb. 17, 2009 (Canada NewsWire via COMTEX News Network) --
Toronto Stock Exchange Symbol: DND
Cipher Pharmaceuticals Inc. (TSX: DND) today announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for CIP-TRAMADOL ER, the Company's extended-release formulation of the analgesic tramadol, which is indicated for the management of moderate to moderately severe chronic pain such as osteoarthritis. While the product meets all the FDA's requirements for manufacturing quality, clinical safety and efficacy, the Company must resolve certain patent issues related to the reference product, Ultram(R) ER, before CIP-TRAMADOL ER is commercialized.
"Tentative approval of our extended-release tramadol is another important achievement for our organization and validates the safety and efficacy of this product, which has an attractive profile for a chronic pain medication," said Larry Andrews, President and CEO of Cipher. "We are working diligently on the remaining steps toward commercialization, including securing a U.S. marketing partner and addressing the outstanding intellectual property issues."
Cipher's revised New Drug Application (NDA) for CIP-TRAMADOL ER was submitted in Q2 2008 as a 505(b)(2) application. Since there are issued U.S. patents for the approved product held by a third party, Cipher was required to certify to the FDA concerning any patents listed in the FDA's Orange Book publication at the time of submission. Cipher's application contained a paragraph III certification acknowledging that the listed patent had not expired and that final approval would be sought after patent expiration in 2014. A paragraph IV certification, which states that the listed patent is invalid, unenforceable, or will not be infringed by the manufacture or sale of the drug, may trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act. To date, this certification has not been filed.
CIP-TRAMADOL ER capsules are based on patented oral controlled-release bead technology and feature both immediate-release and extended-release properties.
Ob wir heute eine kleine Party erleben werden ? Hmm ich weiß es nicht, fakt ist Cipher ist auf dem besten Wege und wenn noch Isotretinoin ende des Jahres bzw 1Q 2010 zugelassen wird dann ist Cipher zu diesen Kursen nicht mehr zuhalten .
Fazit : Eine Aktie mit sehr sehr viel Fantasie ....
Fazit : Eine Aktie mit sehr sehr viel Fantasie ....
3 Produkte bis zum 1Q 2010 am Markt zuhaben ist keine schlechte Bilanz .Mein Kursziel liegt bei 4-6 C$ für die nächsten 18 Monate .
3 Produkte bis zum 1Q 2010 am Markt zuhaben ist keine schlechte Bilanz .Mein Kursziel liegt bei 4-6 C$ für die nächsten 18 Monate .
Cipher reports fiscal 2008 year-end results
Wednesday February 18, 7:00 am ET
Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, Feb. 18 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND - News) today announced its financial and operational results for the fourth quarter and fiscal year ended December 31, 2008.
Fiscal 2008 Summary
-------------------
- Total revenue of $1.5 million, driven by growing sales of Lipofen(R)
and initial contribution from CIP-ISOTRETINOIN licensing agreement.
- Entered into a definitive development, distribution and supply
agreement with Ranbaxy Pharmaceuticals Inc. ("Ranbaxy") for CIP-
ISOTRETINOIN in the United States.
- Solid balance sheet at year end with cash of $9.9 million and no debt
at year end.
- Strengthened management team with the appointment of John MacInnis as
Vice President, Portfolio Development and Licensing.
- Subsequent to year end, received tentative FDA approval for CIP-
TRAMADOL ER for distribution in the United States.
"With one product on the market, two others at the late stages of the development and approval process, a solid balance sheet and a strong core management team, we have built the foundation for sustainable success," said Larry Andrews, President and CEO of Cipher. "Achieving our second commercial partnership in the U.S. was a major milestone in 2008, and we believe Ranbaxy is an excellent partner to support our isotretinoin product. As Kowa expands its sales force, we expect continued growth in Lipofen(R) royalties, creating a steadily increasing revenue stream to offset our operating costs. Looking ahead, we are in a solid financial position from which to build our pipeline this year with novel products."
Financial Review
----------------
Total revenue in 2008 was $1.5 million, compared with $0.5 million in 2007. Revenue from Lipofen(R) totalled $1.3 million in 2008, reflecting the continued market penetration of Lipofen(R) as Kowa expands its sales force. Revenue from CIP-ISOTRETINOIN was $0.2 million in 2008, which includes an amortized portion of the US$1.0 million up-front payment from Ranbaxy for CIP-ISOTRETINOIN. This is the first commercial revenue recorded for this product.
Research and Development ("R&D") expenses for fiscal 2008 were $1.3 million, a decrease of $1.6 million compared with 2007. The reported amount does not include reimbursements of $0.5 million from Ranbaxy related to CIP-ISOTRETINOIN and is net of a $0.4 million tax credit received under the Ontario Innovation Tax Credit program. Adjusting for these items, the total R&D costs incurred in 2008 were $2.2 million, a decrease of $0.7 million for the year, which reflects the advanced stage of development of the Company's three current products. Operating General and Administrative ("OG&A") expenses for fiscal 2008 were $3.6 million, a decrease of $0.6 million or 15% compared with 2007. The decrease in OG&A reflects prudent management of OG&A expenses in general, as well as the simplification of the corporate structure as a result of the voluntary wind-up of the Company's three subsidiaries. The loss for the year ended December 31, 2008 was $3.2 million ($0.13 per basic and diluted share), a decrease of 50% compared with the loss of $6.4 million ($0.27 per basic and diluted share) in fiscal 2007. The improved performance in 2008 was primarily a result of increased revenue generated from the Lipofen(R) U.S. distribution agreement and reduced R&D expenditures during the year.
In Q4 2008, Cipher recorded licensing revenue of $0.4 million, compared with $0.2 million in Q4 2007. Fourth quarter R&D expenses were nil, net of reimbursed R&D costs of $0.2 million, compared with R&D expenses of $0.9 million in Q4 2007. OG&A expenses for Q4 2008 were $0.9 million, compared with $1.0 million in the same period last year. Loss for the three months ended December 31, 2008 was $0.5 million ($0.02 per basic and diluted share), compared with a loss of $1.6 million ($0.07 per basic and diluted share) in the same period last year.
The Company's financial position remained solid at year-end. As at December 31, 2008, Cipher had cash of $9.9 million, compared with $11.0 million as at December 31, 2007.
Product Update
--------------
In July 2007, Cipher entered into a licensing and distribution agreement with ProEthic Pharmaceuticals under which ProEthic was granted the exclusive right to market, sell and distribute Lipofen(R) (Fenofibrate) in the United States. In Q3 2008, ProEthic was acquired by Kowa Company, Ltd. and changed its name to Kowa Pharmaceuticals America, Inc. ("Kowa"). During 2008, Lipofen(R) monthly prescriptions showed steady growth, and Cipher expects this trend to continue as Kowa increases penetration of the primary care physicians in its targeted regions and expands its sales force. Since the Kowa acquisition, the number of sales reps increased to 100, with further expansion planned in the first half of 2009.
During the third quarter of 2008, Cipher achieved a major milestone with the completion of a distribution and supply agreement with Ranbaxy Pharmaceuticals Inc. ("RPI"), a wholly owned subsidiary of Ranbaxy Laboratories Limited, under which Cipher granted RPI the exclusive right to market, sell and distribute CIP-ISOTRETINOIN in the United States. Cipher received an initial upfront milestone payment of US$1 million. The agreement includes additional pre- and post-commercialization milestone payments of up to US$23 million, contingent upon the achievement of certain milestone targets. Once the product is successfully commercialized, Cipher will also receive a royalty in the mid-teens on net sales. In addition, Ranbaxy will reimburse Cipher for all costs associated with the remaining clinical studies required to obtain FDA approval, up to a predetermined cap. Any additional development costs associated with initial FDA approval will be shared equally.
During the second half of 2008, Cipher and its advisors met with the FDA regarding the appropriate design of a safety trial for CIP-ISOTRETINOIN, which the FDA has previously requested in its approvable letter. The Company expects to finalize the study protocol shortly under a Special Protocol Assessment ("SPA") and plans to begin trial enrolment in Q2 2009. In Q4 2008, another important milestone was reached with notice that the United States Patent and Trademark Office issued a patent for CIP-ISOTRETINOIN.
In May 2007, Cipher received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER, the Company's extended-release formulation of tramadol. In December 2007, Cipher announced that it had appealed the position taken by the FDA using the FDA's formal dispute resolution process. In the written response, the Acting Director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research supported the original approvable action. During Q2 2008, Cipher submitted a revised NDA to the FDA, which the Company concluded was the most expeditious path to resolve the regulatory concern raised by the FDA. Cipher's revised NDA was submitted as a 505(b)(2) application and included data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER.
In February 2009, the Company received tentative approval from the FDA. While the product meets all the FDA's requirements for manufacturing quality, clinical safety and efficacy, the Company must resolve certain patent issues associated with the reference product, Ultram(R) ER, before CIP-TRAMADOL ER is commercialized. Since there are issued U.S. patents for the approved product held by a third party, Cipher was required to certify to the FDA concerning any patents listed in the FDA's Orange Book publication at the time of submission. Cipher's application contained a paragraph III certification acknowledging that the listed patent had not expired and that final approval would be sought after patent expiration in 2014. A paragraph IV certification, which states that the listed patent is invalid, unenforceable, or will not be infringed by the manufacture or sale of the drug, may trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act. To date, this certification has not been filed.
Out-licensing discussions with potential commercial partners are ongoing.
Notice of Conference Call
-------------------------
Cipher will hold a conference call today, February 18, 2009, at 8:30 a.m. (ET) to discuss its financial results and other corporate developments. To access the conference call by telephone, dial 416-644-3414 or 1-800-733-7571. A live audio webcast of the call will be available at www.cipherpharma.com. The webcast will be archived for 90 days.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals is a drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies. Cipher's strategy is to in-license products that incorporate proven drug delivery technologies and advance them through the clinical development and regulatory approval stages, after which the products are out-licensed to international partners. Because Cipher's products are based on proven technology platforms applied to currently marketed drugs, they are expected to have lower approval risk, shorter development timelines and significantly lower development costs. The Company's lead compound, CIP-FENOFIBRATE, received final approval from the U.S. Food and Drug Administration and Health Canada in the first quarter of 2006. The product is being marketed in the United States by Kowa Pharmaceuticals America under the label Lipofen(R). In addition, Cipher is developing formulations of the pain reliever tramadol (tentative FDA approval in February 2009) and the acne treatment isotretinoin (FDA approvable letter in April 2007).
Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit www.cipherpharma.com.
Forward-Looking Statements
Statements made in this news release, other than those concerning historical financial information, may be forward-looking and therefore subject to various risks and uncertainties. Some forward-looking statements may be identified by words like "may", "will", "anticipate", "estimate", "expect", "intend", or "continue" or the negative thereof or similar variations. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. Factors that could cause results to vary include those identified in the Company's Annual Information Form and other filings with Canadian securities regulatory authorities, such as the applicability of patents and proprietary technology; possible patent litigation; regulatory approval of products in the Company's pipeline; changes in government regulation or regulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships for product candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals; intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability to access capital to fund R&D; and the ability to attract and retain key personnel. All forward-looking statements presented herein should be considered in conjunction with such filings. Except as required by Canadian securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.
Cipher Pharmaceuticals Inc.
Balance Sheets
(in thousands of dollars)
As at
December 31, December 31,
2008 2007
ASSETS
Current assets
Cash $ 9,881 $ 10,961
Accounts receivable 512 1,396
Income taxes receivable 6 128
Prepaid expenses and other current assets 380 56
Current portion of loan receivable (note 5) 608 -
-------------------------------------------------------------------------
11,387 12,541
Property and equipment, net (note 4) 147 208
Loan receivable (note 5) 717 1,377
Intangible assets, net (note 6) 4,126 4,592
-------------------------------------------------------------------------
-------------------------------------------------------------------------
$ 16,377 $ 18,718
-------------------------------------------------------------------------
-------------------------------------------------------------------------
LIABILITIES
Current liabilities
Accounts payable and accrued liabilities $ 1,178 $ 1,059
Current portion of deferred revenue 1,177 790
-------------------------------------------------------------------------
2,355 1,849
Deferred revenue 994 1,192
-------------------------------------------------------------------------
3,349 3,041
-------------------------------------------------------------------------
SHAREHOLDERS' EQUITY
Share capital (note 7) 49,948 49,948
Contributed surplus (note 8) 31,613 31,032
Deficit (68,533) (65,303)
-------------------------------------------------------------------------
13,028 15,677
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------------------------------------------------
$ 16,377 $ 18,718
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these financial statements
Cipher Pharmaceuticals Inc.
Statements of Operations and Comprehensive Loss
(in thousands of dollars, except per share amounts)
For the year ended
December 31, December 31,
2008 2007
(Consolidated
- note 1)
Revenues
Licensing revenue $ 1,543 $ 311
Product sales - 227
-------------------------------------------------------------------------
1,543 538
-------------------------------------------------------------------------
Expenses
Cost of goods sold - 171
Research and development (note 9) 1,303 2,926
Operating, general and administrative 3,565 4,183
Amortization of property and equipment 71 50
Amortization of intangible assets 466 466
Recovery of legal fees and court
costs (note 10) (176) -
Interest income (456) (813)
-------------------------------------------------------------------------
4,773 6,983
-------------------------------------------------------------------------
Loss and comprehensive loss for the year $ (3,230) $ (6,445)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per share (note 12) $ (0.13) $ (0.27)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these financial statements
Cipher Pharmaceuticals Inc.
Statements of Deficit
(in thousands of dollars)
For the year ended
December 31, December 31,
2008 2007
(Consolidated
- note 1)
Deficit, beginning of year $ (65,303) $ (58,858)
Loss for the year (3,230) (6,445)
-------------------------------------------------------------------------
Deficit, end of year $ (68,533) $ (65,303)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these financial statements
Cipher Pharmaceuticals Inc.
Statements of Cash Flows
(in thousands of dollars)
For the year ended
December 31, December 31,
2008 2007
(Consolidated
- note 1)
Cash provided by (used in)
Operating activities
Loss $ (3,230) $ (6,445)
Items not affecting cash
Amortization of property and equipment 71 50
Amortization of intangible assets 466 466
Stock-based compensation expense 581 659
Imputed interest (note 5) (136) (191)
-------------------------------------------------------------------------
(2,248) (5,461)
Net change in non-cash operating
items (note 13) 990 704
Drawdown of loan receivable (note 5) 188 800
-------------------------------------------------------------------------
(1,070) (3,957)
-------------------------------------------------------------------------
Investing activities
Purchase of property and equipment (10) (159)
-------------------------------------------------------------------------
Decrease in cash (1,080) (4,116)
Cash, beginning of year 10,961 15,077
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Cash, end of year $ 9,881 $ 10,961
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these financial statements
Cipher Pharmaceuticals Inc.
Notes to Financial Statements
December 31, 2008
(in thousands of dollars, except per share amounts)
1 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
These financial statements have been prepared in accordance with
Canadian generally accepted accounting principles.
Basis of presentation
The prior year statements of operations and comprehensive loss,
deficit and cash flows were presented on a consolidated basis and
included Cipher Pharmaceuticals Inc. (the "Company") and its wholly-
owned subsidiaries Cipher Canada Inc., Cipher Holdings (Barbados)
Ltd. and Cipher Pharmaceuticals Ltd. There was no activity in the
three wholly-owned subsidiaries during 2008 and on October 31, 2008
the three companies were wound up by way of voluntary dissolution.
Significant accounting policies used in the preparation of these
financial statements are as follows:
Translation of foreign currencies
Revenues and expenses denominated in foreign currencies are
translated into Canadian dollars using the exchange rate in effect at
the transaction date. Monetary assets and liabilities are translated
using the rate in effect at the balance sheet date and non-monetary
items are translated at historical exchange rates. Related exchange
gains and losses are included in the determination of the loss for
the year.
Use of estimates
The preparation of these financial statements requires management to
make estimates and assumptions that could affect the reported amounts
of assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting
periods presented. Significant areas requiring the use of management
estimates include intangible assets and income taxes. By their
nature, these estimates are subject to measurement uncertainty.
Actual results could differ from the estimates and assumptions.
Property and equipment
Property and equipment are recorded at cost less accumulated
amortization. Amortization is computed using the straight-line method
using the following estimated useful lives of the assets or lease
terms:
Computer equipment 3 years
Computer software 3 years
Furniture and fixtures 5 years
Leasehold improvements over the term of the lease
Impairment of long-lived assets
Long-lived assets are tested for recoverability whenever events or
changes in circumstances indicate the carrying value may not be
recoverable. An impairment loss is recognized when the carrying
amount of a long-lived asset exceeds the sum of the estimated
undiscounted cash flows from the long-lived asset. An impairment loss
is measured as the amount by which the carrying amount of the long-
lived asset exceeds the estimated fair value.
Intangible assets
Intangible assets consist of marketing and other rights relating to
products and are initially recorded at cost. Intangible assets have a
finite life and are amortized using the straight-line method over
their estimated period of useful life, which is determined to be 3.5
years from the date of regulatory (generally, U.S. Food and Drug
Administration ("FDA")) approval for marketing the related product.
Intangible assets are reviewed for impairment when events or other
changes in circumstances indicate that the carrying amount of the
assets may not be recoverable.
Revenue recognition
The Company recognizes revenue from product sales contracts and
licensing and distribution agreements, which may include multiple
elements. The individual elements of each agreement are divided into
separate units of accounting, if certain criteria are met. The
applicable revenue recognition approach is then applied to each unit.
Otherwise, the applicable revenue recognition criteria are applied to
combined elements as a single unit of accounting.
Product sales - revenue from product sales contracts is recognized
when the product is shipped to the Company's customers, at which time
ownership is transferred.
Licensing revenues - for up-front licensing payments and pre-
commercialization milestones, revenue is deferred and recognized on a
straight-line basis over the estimated term that the Company
maintains substantive contractual obligations. Post-commercialization
milestone payments are recognized as revenue when the underlying
condition is met, the milestone is not a condition to future
deliverables and collectibility is reasonably assured. Otherwise,
these milestone payments are recognized as revenue over the remaining
term of the underlying agreement or the term over which the Company
maintains substantive contractual obligations. Royalty revenue is
recognized in the period in which the Company earns the royalty.
Amounts received in advance of recognition as revenue are included in
deferred revenue. Revenue from licensing and distribution agreements
is presented on a net basis.
Research and development
The Company conducts various research and development programs and
incurs costs related to these activities, including employee
compensation, materials, professional services and services provided
by contract research organizations. Research and development costs,
net of related tax credits, are expensed in the periods in which they
are incurred.
Income taxes
The Company uses the asset and liability method of accounting for
income taxes. Under this method, future tax assets and liabilities
are determined based on differences between the financial reporting
and income tax bases of assets and liabilities and are measured using
enacted or substantively enacted tax rates and laws that will be in
effect when the difference is expected to reverse. The Company
provides a valuation allowance for future tax assets when it is more
likely than not that some or all of the future tax assets will not be
realized.
Stock-based compensation
The fair value of stock options granted after October 1, 2002 is
recognized as compensation expense on a straight-line basis over the
applicable stock option vesting period. Stock-based compensation
expense is included in operating, general and administrative expense
in the statements of operations and contributed surplus in the
balance sheets. The consideration received on the exercise of stock
options is credited to share capital at the time of exercise.
Financial instruments
Financial instruments are measured at fair value except for loans and
receivables, held-to-maturity investments and other financial
liabilities, which are measured at cost or amortized cost. Gains and
losses on held-for-trading financial assets and liabilities are
recognized in net earnings in the period in which they arise.
Unrealized gains and losses, including changes in foreign exchange
rates on available-for-sale financial assets, are recognized in
comprehensive income until the financial assets are derecognized or
impaired, at which time any unrealized gains or losses are recorded
in net earnings.
The following is the basis of classification and measurement of the
Company's financial instruments:
- Cash is classified as held-for-trading and is measured at fair
value;
- Accounts receivable and loan receivable are classified as loans
and receivables and recorded at cost, which at initial
measurement corresponds to fair value. After initial fair value
measurement, they are measured at amortized cost; and
- Accounts payable and accrued liabilities are classified as other
financial liabilities. They are initially measured at fair value
and, if necessary, subsequent revaluations are recorded at
amortized cost.
2 ADOPTION OF NEW ACCOUNTING POLICIES
Effective January 1, 2008, the Company adopted the following new CICA
accounting standards: Section 3862, Financial Instruments -
Disclosures and Section 1535, Capital Disclosures.
CICA Section 3862, Financial Instruments - Disclosures, establishes
standards for the disclosure of financial instruments including
disclosing the significance of financial instruments and the nature
and extent of risks arising from financial instruments.
CICA Section 1535, Capital Disclosures, establishes standards for
disclosing aspects of the entity's capital management strategy. This
standard requires disclosure of both quantitative and qualitative
disclosures around the entity's objectives, policies and processes
for managing capital requirements and the consequences of non-
compliance.
The adoption of these new standards had no impact on the Company's
financial position or results of operations.
3 RISK MANAGEMENT
Financial risk management
In the normal course of business, the Company is exposed to a number
of financial risks that can affect its operating performance. These
risks are: credit risk, liquidity risk and market risk. The Company's
overall risk management program and prudent business practices
seek to minimize any potential adverse affects on the Company's
financial performance.
(i) Credit risk
Accounts receivable - the Company licenses its products to
distribution partners in major markets. The credit risk associated
with the accounts receivable pursuant to these agreements is
evaluated during initial negotiations and on an ongoing basis. There
have been no events of default under these agreements. As of
December 31, 2008, no accounts receivable balances were considered
impaired and $32 was considered past due.
Loan receivable - the loan receivable is repaid in annual instalments
over a five year period, with two instalments remaining as at
December 31, 2008. All prior instalments have been received on
schedule and there have been no events of default under the loan
agreement.
(ii) Liquidity risk
The Company has no long term debt with specified repayment terms.
Accounts payable and accrued liabilities are settled in the regular
course of business, based on negotiated terms with trade suppliers.
All components of the balance of $1,178 as at December 31, 2008 will
be settled in less than one year. The carrying value of the balances
approximate their fair value as the impact of discounting is not
significant.
(iii) Market risk
Currency risk - the majority of the Company's revenue and a portion
of its expenses are denominated in US currency. At December 31, 2008
the accounts receivable balance includes a total of US$338 and
accounts payable and accrued liabilities includes a total of US$478.
There is no active hedging program currently in place due to the
relatively short time frame for settlement of these balances. A 10%
change in the US/CDN exchange rate on the December 31, 2008 balances
would have had a $14 impact on net income.
Interest rate risk - the fair value of the loan receivable is based
upon a discounted cash flow method, whereby a risk premium is added
to the Bank of Canada risk-free interest rate. A 10% change in the
risk-free interest rate would not have had a significant impact on
imputed interest.
Capital risk management
Shareholders' equity is managed as the capital of the Company. The
Company's objective when managing capital is to safeguard its ability
to continue as a going concern in order to provide returns for
shareholders and to maintain an optimal capital structure to minimize
the cost of capital. In order to maintain or adjust the capital
structure, the Company may issue new common shares from time to time.
4 PROPERTY AND EQUIPMENT
The following is a summary of property and equipment as at
December 31, 2008:
December 31, 2008 December 31, 2007
---------------------------------------------------------------------
Accumulated Accumulated
Cost Amortization Cost Amortization
---------------------------------------------------------------------
Computer equipment $ 101 $ 79 $ 91 $ 58
Computer software 35 24 35 14
Furniture and fixtures 126 58 126 31
Leasehold improvements 67 21 67 8
---------------------------------------------
329 $ 182 319 $ 111
Accumulated amortization (182) (111)
---------------------------------------------------------------------
$ 147 $ 208
---------------------------------------------------------------------
---------------------------------------------------------------------
5 LOAN RECEIVABLE
On February 28, 2005, the Company completed the sale of its wholly-
owned pharmaceutical research services business, Pharma Medica
Research Inc. (Pharma Medica). Consideration consisted of a cash
payment of $14,000 and a deferred payment of $4,000. The deferred
payment is non-interest bearing and is repayable in annual
instalments of $800 over a five year period. As the deferred payment
is non-interest bearing, it was recorded at its fair value of $3,112
based on a discount rate of 9%. Imputed interest of $136 has been
recorded on this deferred payment during the year ended December 31,
2008 ($191 during the year ended December 31, 2007). In accordance
with the terms of the deferred payment agreement, $800 of clinical
services purchased from Pharma Medica during 2007 were offset against
the annual payment that was due on January 30, 2008. During the year
ended December 31, 2008, $188 of clinical services purchased from
Pharma Medica have been offset against the next annual payment, which
is due on January 30, 2009.
6 INTANGIBLE ASSETS
During fiscal 2001, the Company entered into certain agreements with
Galephar Pharmaceutical Research Inc. ("Galephar") for the rights to
package, test, obtain regulatory approvals and market certain
products in various countries around the world. In accordance with
the terms of the agreements, the Company has acquired these
intangible rights through an investment in three separate series of
preferred shares of Galephar. The Company may be required to pay
additional amounts to Galephar in respect of the CIP-ISOTRETINOIN and
CIP-TRAMADOL ER intangible rights of up to $1,837 (US$1,500) if
certain future milestones are achieved as defined in the agreements.
These additional payments will be made in the form of additional
Galephar preferred share purchases. The recoverability of these
intangible rights is dependant upon sufficient revenues being
generated from the related products currently under development and
commercialization.
Upon receipt of FDA approval in January 2006, the Company began
amortizing the intangible rights related to CIP-FENOFIBRATE. As at
December 31, 2008, no other products have received FDA approval.
With regard to CIP-FENOFIBRATE, in July 2007 the Company entered into
a licensing and distribution agreement with Kowa Pharmaceuticals
America, Inc. ("Kowa"), formerly ProEthic Pharmaceuticals, Inc.,
under which Kowa was granted the exclusive right to market, sell and
distribute Lipofen in the United States. The Company received an up-
front licensing payment of US$2 million and, under the terms of the
agreement, could receive additional milestone payments of up to
US$20 million based on the achievement of certain net sales targets.
The Company also receives a royalty based on a percentage of net
sales. These elements are reflected in licensing revenue, which also
incorporates direct product-related expenses and amounts due to
Galephar, the Company's technology partner. Revenue from licensing
and distribution agreements is presented on a net basis. After
product-related expenses are deducted, approximately 50% of all
milestone and royalty payments received by the Company under the
agreement will be paid to Galephar. Lipofen was launched in the U.S.
market in September 2007.
The Company's US$2 million investment in Galephar preferred shares
related to CIP-FENOFIBRATE is being repaid by Galephar in a series of
quarterly payments. A total of US$800 has been received as at
December 31, 2008 and a further amount of US$199 was offset against
amounts owing to Galephar. These amounts are included in revenue over
the same period as up-front licensing payments are recognized.
In August 2008, the Company entered into a development, distribution
and supply agreement with Ranbaxy Pharmaceuticals Inc. ("Ranbaxy")
under which Ranbaxy was granted the exclusive right to market, sell
and distribute CIP-ISOTRETINOIN in the United States. Under the terms
of the agreement, the Company received an up-front licensing payment
of US$1 million and could receive additional pre- and post-
commercialization milestone payments of up to US$23 million, based on
the achievement of certain milestone targets. Once the product is
successfully commercialized, the Company will also receive a royalty
based on a percentage of net sales. In addition, Ranbaxy will
reimburse the Company for all costs associated with the clinical
studies required by the FDA to secure NDA approval, up to a
predetermined cap. Any additional development costs associated with
initial FDA approval will be shared equally. The Company is
responsible for all product development activities, including
management of the clinical studies required by the FDA to secure NDA
approval and is also responsible for product supply and
manufacturing, which will be fulfilled by Galephar. After product-
related expenses are deducted, approximately 50% of all milestone and
royalty payments received by the Company under the agreement will be
paid to Galephar.
The following is a summary of intangible assets as at December 31,
2008:
December 31, 2008 December 31, 2007
---------------------------------------------------------------------
Accumulated Accumulated
Amortization Amortization
Cost and Writedowns Cost and Writedowns
---------------------------------------------------------------------
CIP-FENOFIBRATE $ 3,014 $ 2,080 $ 3,014 $ 1,614
CIP-ISOTRETINOIN 1,883 426 1,883 426
CIP-TRAMADOL ER 2,161 426 2,161 426
------------------------------------------------
7,058 $ 2,932 7,058 $ 2,466
Accumulated
amortization and
writedowns (2,932) (2,466)
---------------------------------------------------------------------
$ 4,126 $ 4,592
---------------------------------------------------------------------
---------------------------------------------------------------------
7 SHARE CAPITAL
Authorized share capital
The authorized share capital consists of an unlimited number of
preference shares, issuable in series, and an unlimited number of
voting common shares.
Issued share capital
The following is a summary of the changes in share capital from
December 31, 2006 to December 31, 2008:
Number of
common shares Amount
(in thousands) $
Balance outstanding - December 31, 2006 24,036 49,891
Options exercised during 2007 19 57
--------------------------
Balance outstanding - December 31, 2007
and December 31, 2008 24,055 49,948
--------------------------
--------------------------
Stock option plan
The following is a summary of the changes in the stock options
outstanding from December 31, 2006 to December 31, 2008:
Weighted
average
Number of exercise
options price
(in thousands) $
Balance outstanding - December 31, 2006 889 2.96
Options granted during 2007 274 3.90
Options exercised during 2007 (38) 1.90
Options cancelled during 2007 (127) 2.16
---------------
Balance outstanding - December 31, 2007 998 3.36
Options granted during 2008 483 0.78
Options that expired or were
cancelled during 2008 (105) 2.55
---------------
Balance outstanding - December 31, 2008 1,376 2.51
---------------
---------------
At December 31, 2008, 540,482 options were fully vested and
exercisable (309,741 at December 31, 2007).
During 2008, the Company issued 483,000 stock options under the
employee and director stock option plan, with exercise prices ranging
from $0.45 to $1.05, 25% of which vest on either February 28,
November 7 or December 3 of each year for the next four years,
commencing in 2009, and all of which expire in 2018. Total
compensation cost for these stock options is estimated to be $334.
This cost will be recognized over the vesting period of the stock
options.
The stock options issued during 2008 were valued using the Black-
Scholes option pricing model with the following assumptions:
Risk-free interest rate 2.27% - 3.14%
Expected life 10 years
Expected volatility 93% - 102%
Expected dividend Nil
The following is a summary of the outstanding options as at
December 31, 2008:
Expiry date Exercise Number of options (in thousands)
price --------------------------------------
$ Vested Unvested Total
January 11, 2012 1.09 125 - 125
September 17, 2014 2.35 125 - 125
March 23, 2016 4.12 100 100 200
June 28, 2016 4.00 90 90 180
August 8, 2016 4.33 10 10 20
September 13, 2016 2.90 34 35 69
March 9, 2017 3.90 56 168 224
February 28, 2018 1.05 - 213 213
November 7, 2018 0.45 - 180 180
December 3, 2018 0.50 - 40 40
--------------------------------------
540 836 1,376
--------------------------------------
--------------------------------------
8 CONTRIBUTED SURPLUS
The following is a summary of the changes in contributed surplus from
December 31, 2006 to December 31, 2008:
Amount
$
Balance - December 31, 2006 30,430
Options exercised during 2007 (57)
Stock-based compensation expense during 2007 659
------------
Balance - December 31, 2007 31,032
Stock-based compensation expense during 2008 581
------------
Balance - December 31, 2008 31,613
------------
------------
9 RESEARCH AND DEVELOPMENT
A total of $2,242 of research and development costs were incurred in
2008 ($2,926 in 2007). The research and development expense reflected
in the Statement of Operations is presented net of Ontario Innovation
Tax Credit ("OITC") program credits of $440 for qualifying research
and development expenditures for 2006 through 2008 and an amount of
$499 reimbursed by Ranbaxy. Under the terms of the agreement with
Ranbaxy, research and development costs incurred for clinical studies
required by the FDA to secure approval for CIP-ISOTRETINOIN are
reimbursed to the Company and as a result, there was a nil impact to
research and development expense with respect to these costs. There
were no OITC credits or reimbursements recorded in 2007.
10 RECOVERY OF LEGAL FEES AND COURT COSTS
On July 30, 2008, the Federal Court of Canada ruled in the Company's
favour and awarded a recovery of legal fees and court costs from
prior years in the amount of $176.
11 INCOME TAXES
The provision for income taxes differs from the amount computed by
applying the statutory income tax rate to the loss for the year. The
sources and tax effects of the differences are as follows:
For the year ended
December 31,
2008 2007
$ $
Statutory income tax rate of 33.5% applied
to loss for the year (2007 - 36.12%) (1,082) (2,328)
Permanent differences 57 253
Change in enacted income tax rates
and other items (599) (1,670)
Change in valuation allowance 1,624 3,745
-----------------------
Provision for income taxes - -
-----------------------
-----------------------
The significant components of future income tax assets are summarized
as follows:
As at
December 31,
2008 2007
$ $
Non-capital losses 10,776 9,864
Excess of tax value of property and
equipment over book value 49 27
SR&ED expenditure pool 3,466 3,206
Excess of tax value of intangible assets
over book value 7,581 7,513
Benefit of investment tax credits 2,057 1,694
Capital losses 93 -
Deductible share issue costs 127 190
Other temporary differences 487 518
-----------------------
24,636 23,012
Valuation allowance (24,636) (23,012)
-----------------------
- -
-----------------------
-----------------------
The Company has non-capital loss carry forwards of $37,200 as at
December 31, 2008 that expire in varying amounts from 2014 to 2028.
The Company has Scientific Research and Experimental Development
("SR&ED") expenditures of $11,900 which can be carried forward
indefinitely to reduce future years' taxable income.
The Company has approximately $2,600 of investment tax credits on
SR&ED expenditures that are available to be applied against federal
taxes otherwise payable in future years and expire in varying amounts
from 2013 to 2028.
12 LOSS PER SHARE
Loss per share is calculated using the weighted average number of
shares outstanding. The weighted average number of shares outstanding
for the year ended December 31, 2008 was 24,054,878 (for the year
ended December 31, 2007 - 24,049,174).
As the Company had a loss for each of the periods presented, basic
and diluted loss per share are the same because the exercise of all
stock options would have an anti-dilutive effect.
13 SUPPLEMENTAL CASH FLOW INFORMATION
The following is a summary of the changes in non-cash operating
items:
For the year ended
December 31,
2008 2007
$ $
Accounts receivable 884 (1,236)
Income taxes receivable 122 (33)
Prepaid expenses and other current assets (324) (24)
Accounts payable and accrued liabilities 119 15
Deferred revenue 189 1,982
-----------------------
990 704
-----------------------
-----------------------
14 COMPARATIVE FIGURES
Certain comparative figures for the previous year have been
reclassified to conform to current financial statement presentation.
For further information
Craig Armitage, Investor Relations, The Equicom Group, (416) 815-0700 ext 278, (416) 815-0080 fax, carmitage@equicomgroup.com
Larry Andrews, President and CEO, Cipher Pharmaceuticals, (905) 602-5840 ext 324, (905) 602-0628 fax, landrews@cipherpharma.com
--------------------------------------------------------------------------------
Source: Cipher Pharmaceuticals Inc.
Wednesday February 18, 7:00 am ET
Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, Feb. 18 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND - News) today announced its financial and operational results for the fourth quarter and fiscal year ended December 31, 2008.
Fiscal 2008 Summary
-------------------
- Total revenue of $1.5 million, driven by growing sales of Lipofen(R)
and initial contribution from CIP-ISOTRETINOIN licensing agreement.
- Entered into a definitive development, distribution and supply
agreement with Ranbaxy Pharmaceuticals Inc. ("Ranbaxy") for CIP-
ISOTRETINOIN in the United States.
- Solid balance sheet at year end with cash of $9.9 million and no debt
at year end.
- Strengthened management team with the appointment of John MacInnis as
Vice President, Portfolio Development and Licensing.
- Subsequent to year end, received tentative FDA approval for CIP-
TRAMADOL ER for distribution in the United States.
"With one product on the market, two others at the late stages of the development and approval process, a solid balance sheet and a strong core management team, we have built the foundation for sustainable success," said Larry Andrews, President and CEO of Cipher. "Achieving our second commercial partnership in the U.S. was a major milestone in 2008, and we believe Ranbaxy is an excellent partner to support our isotretinoin product. As Kowa expands its sales force, we expect continued growth in Lipofen(R) royalties, creating a steadily increasing revenue stream to offset our operating costs. Looking ahead, we are in a solid financial position from which to build our pipeline this year with novel products."
Financial Review
----------------
Total revenue in 2008 was $1.5 million, compared with $0.5 million in 2007. Revenue from Lipofen(R) totalled $1.3 million in 2008, reflecting the continued market penetration of Lipofen(R) as Kowa expands its sales force. Revenue from CIP-ISOTRETINOIN was $0.2 million in 2008, which includes an amortized portion of the US$1.0 million up-front payment from Ranbaxy for CIP-ISOTRETINOIN. This is the first commercial revenue recorded for this product.
Research and Development ("R&D") expenses for fiscal 2008 were $1.3 million, a decrease of $1.6 million compared with 2007. The reported amount does not include reimbursements of $0.5 million from Ranbaxy related to CIP-ISOTRETINOIN and is net of a $0.4 million tax credit received under the Ontario Innovation Tax Credit program. Adjusting for these items, the total R&D costs incurred in 2008 were $2.2 million, a decrease of $0.7 million for the year, which reflects the advanced stage of development of the Company's three current products. Operating General and Administrative ("OG&A") expenses for fiscal 2008 were $3.6 million, a decrease of $0.6 million or 15% compared with 2007. The decrease in OG&A reflects prudent management of OG&A expenses in general, as well as the simplification of the corporate structure as a result of the voluntary wind-up of the Company's three subsidiaries. The loss for the year ended December 31, 2008 was $3.2 million ($0.13 per basic and diluted share), a decrease of 50% compared with the loss of $6.4 million ($0.27 per basic and diluted share) in fiscal 2007. The improved performance in 2008 was primarily a result of increased revenue generated from the Lipofen(R) U.S. distribution agreement and reduced R&D expenditures during the year.
In Q4 2008, Cipher recorded licensing revenue of $0.4 million, compared with $0.2 million in Q4 2007. Fourth quarter R&D expenses were nil, net of reimbursed R&D costs of $0.2 million, compared with R&D expenses of $0.9 million in Q4 2007. OG&A expenses for Q4 2008 were $0.9 million, compared with $1.0 million in the same period last year. Loss for the three months ended December 31, 2008 was $0.5 million ($0.02 per basic and diluted share), compared with a loss of $1.6 million ($0.07 per basic and diluted share) in the same period last year.
The Company's financial position remained solid at year-end. As at December 31, 2008, Cipher had cash of $9.9 million, compared with $11.0 million as at December 31, 2007.
Product Update
--------------
In July 2007, Cipher entered into a licensing and distribution agreement with ProEthic Pharmaceuticals under which ProEthic was granted the exclusive right to market, sell and distribute Lipofen(R) (Fenofibrate) in the United States. In Q3 2008, ProEthic was acquired by Kowa Company, Ltd. and changed its name to Kowa Pharmaceuticals America, Inc. ("Kowa"). During 2008, Lipofen(R) monthly prescriptions showed steady growth, and Cipher expects this trend to continue as Kowa increases penetration of the primary care physicians in its targeted regions and expands its sales force. Since the Kowa acquisition, the number of sales reps increased to 100, with further expansion planned in the first half of 2009.
During the third quarter of 2008, Cipher achieved a major milestone with the completion of a distribution and supply agreement with Ranbaxy Pharmaceuticals Inc. ("RPI"), a wholly owned subsidiary of Ranbaxy Laboratories Limited, under which Cipher granted RPI the exclusive right to market, sell and distribute CIP-ISOTRETINOIN in the United States. Cipher received an initial upfront milestone payment of US$1 million. The agreement includes additional pre- and post-commercialization milestone payments of up to US$23 million, contingent upon the achievement of certain milestone targets. Once the product is successfully commercialized, Cipher will also receive a royalty in the mid-teens on net sales. In addition, Ranbaxy will reimburse Cipher for all costs associated with the remaining clinical studies required to obtain FDA approval, up to a predetermined cap. Any additional development costs associated with initial FDA approval will be shared equally.
During the second half of 2008, Cipher and its advisors met with the FDA regarding the appropriate design of a safety trial for CIP-ISOTRETINOIN, which the FDA has previously requested in its approvable letter. The Company expects to finalize the study protocol shortly under a Special Protocol Assessment ("SPA") and plans to begin trial enrolment in Q2 2009. In Q4 2008, another important milestone was reached with notice that the United States Patent and Trademark Office issued a patent for CIP-ISOTRETINOIN.
In May 2007, Cipher received an approvable letter from the FDA pertaining to its NDA for CIP-TRAMADOL ER, the Company's extended-release formulation of tramadol. In December 2007, Cipher announced that it had appealed the position taken by the FDA using the FDA's formal dispute resolution process. In the written response, the Acting Director of the Office of Drug Evaluation II, Center for Drug Evaluation and Research supported the original approvable action. During Q2 2008, Cipher submitted a revised NDA to the FDA, which the Company concluded was the most expeditious path to resolve the regulatory concern raised by the FDA. Cipher's revised NDA was submitted as a 505(b)(2) application and included data from additional pharmacokinetic studies conducted by the Company comparing CIP-TRAMADOL ER to Ultram(R) ER.
In February 2009, the Company received tentative approval from the FDA. While the product meets all the FDA's requirements for manufacturing quality, clinical safety and efficacy, the Company must resolve certain patent issues associated with the reference product, Ultram(R) ER, before CIP-TRAMADOL ER is commercialized. Since there are issued U.S. patents for the approved product held by a third party, Cipher was required to certify to the FDA concerning any patents listed in the FDA's Orange Book publication at the time of submission. Cipher's application contained a paragraph III certification acknowledging that the listed patent had not expired and that final approval would be sought after patent expiration in 2014. A paragraph IV certification, which states that the listed patent is invalid, unenforceable, or will not be infringed by the manufacture or sale of the drug, may trigger patent infringement litigation and a stay of up to 30 months under the Hatch-Waxman Act. To date, this certification has not been filed.
Out-licensing discussions with potential commercial partners are ongoing.
Notice of Conference Call
-------------------------
Cipher will hold a conference call today, February 18, 2009, at 8:30 a.m. (ET) to discuss its financial results and other corporate developments. To access the conference call by telephone, dial 416-644-3414 or 1-800-733-7571. A live audio webcast of the call will be available at www.cipherpharma.com. The webcast will be archived for 90 days.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals is a drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies. Cipher's strategy is to in-license products that incorporate proven drug delivery technologies and advance them through the clinical development and regulatory approval stages, after which the products are out-licensed to international partners. Because Cipher's products are based on proven technology platforms applied to currently marketed drugs, they are expected to have lower approval risk, shorter development timelines and significantly lower development costs. The Company's lead compound, CIP-FENOFIBRATE, received final approval from the U.S. Food and Drug Administration and Health Canada in the first quarter of 2006. The product is being marketed in the United States by Kowa Pharmaceuticals America under the label Lipofen(R). In addition, Cipher is developing formulations of the pain reliever tramadol (tentative FDA approval in February 2009) and the acne treatment isotretinoin (FDA approvable letter in April 2007).
Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit www.cipherpharma.com.
Forward-Looking Statements
Statements made in this news release, other than those concerning historical financial information, may be forward-looking and therefore subject to various risks and uncertainties. Some forward-looking statements may be identified by words like "may", "will", "anticipate", "estimate", "expect", "intend", or "continue" or the negative thereof or similar variations. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. Factors that could cause results to vary include those identified in the Company's Annual Information Form and other filings with Canadian securities regulatory authorities, such as the applicability of patents and proprietary technology; possible patent litigation; regulatory approval of products in the Company's pipeline; changes in government regulation or regulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships for product candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals; intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability to access capital to fund R&D; and the ability to attract and retain key personnel. All forward-looking statements presented herein should be considered in conjunction with such filings. Except as required by Canadian securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.
Cipher Pharmaceuticals Inc.
Balance Sheets
(in thousands of dollars)
As at
December 31, December 31,
2008 2007
ASSETS
Current assets
Cash $ 9,881 $ 10,961
Accounts receivable 512 1,396
Income taxes receivable 6 128
Prepaid expenses and other current assets 380 56
Current portion of loan receivable (note 5) 608 -
-------------------------------------------------------------------------
11,387 12,541
Property and equipment, net (note 4) 147 208
Loan receivable (note 5) 717 1,377
Intangible assets, net (note 6) 4,126 4,592
-------------------------------------------------------------------------
-------------------------------------------------------------------------
$ 16,377 $ 18,718
-------------------------------------------------------------------------
-------------------------------------------------------------------------
LIABILITIES
Current liabilities
Accounts payable and accrued liabilities $ 1,178 $ 1,059
Current portion of deferred revenue 1,177 790
-------------------------------------------------------------------------
2,355 1,849
Deferred revenue 994 1,192
-------------------------------------------------------------------------
3,349 3,041
-------------------------------------------------------------------------
SHAREHOLDERS' EQUITY
Share capital (note 7) 49,948 49,948
Contributed surplus (note 8) 31,613 31,032
Deficit (68,533) (65,303)
-------------------------------------------------------------------------
13,028 15,677
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------------------------------------------------
$ 16,377 $ 18,718
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these financial statements
Cipher Pharmaceuticals Inc.
Statements of Operations and Comprehensive Loss
(in thousands of dollars, except per share amounts)
For the year ended
December 31, December 31,
2008 2007
(Consolidated
- note 1)
Revenues
Licensing revenue $ 1,543 $ 311
Product sales - 227
-------------------------------------------------------------------------
1,543 538
-------------------------------------------------------------------------
Expenses
Cost of goods sold - 171
Research and development (note 9) 1,303 2,926
Operating, general and administrative 3,565 4,183
Amortization of property and equipment 71 50
Amortization of intangible assets 466 466
Recovery of legal fees and court
costs (note 10) (176) -
Interest income (456) (813)
-------------------------------------------------------------------------
4,773 6,983
-------------------------------------------------------------------------
Loss and comprehensive loss for the year $ (3,230) $ (6,445)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per share (note 12) $ (0.13) $ (0.27)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these financial statements
Cipher Pharmaceuticals Inc.
Statements of Deficit
(in thousands of dollars)
For the year ended
December 31, December 31,
2008 2007
(Consolidated
- note 1)
Deficit, beginning of year $ (65,303) $ (58,858)
Loss for the year (3,230) (6,445)
-------------------------------------------------------------------------
Deficit, end of year $ (68,533) $ (65,303)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these financial statements
Cipher Pharmaceuticals Inc.
Statements of Cash Flows
(in thousands of dollars)
For the year ended
December 31, December 31,
2008 2007
(Consolidated
- note 1)
Cash provided by (used in)
Operating activities
Loss $ (3,230) $ (6,445)
Items not affecting cash
Amortization of property and equipment 71 50
Amortization of intangible assets 466 466
Stock-based compensation expense 581 659
Imputed interest (note 5) (136) (191)
-------------------------------------------------------------------------
(2,248) (5,461)
Net change in non-cash operating
items (note 13) 990 704
Drawdown of loan receivable (note 5) 188 800
-------------------------------------------------------------------------
(1,070) (3,957)
-------------------------------------------------------------------------
Investing activities
Purchase of property and equipment (10) (159)
-------------------------------------------------------------------------
Decrease in cash (1,080) (4,116)
Cash, beginning of year 10,961 15,077
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Cash, end of year $ 9,881 $ 10,961
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these financial statements
Cipher Pharmaceuticals Inc.
Notes to Financial Statements
December 31, 2008
(in thousands of dollars, except per share amounts)
1 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
These financial statements have been prepared in accordance with
Canadian generally accepted accounting principles.
Basis of presentation
The prior year statements of operations and comprehensive loss,
deficit and cash flows were presented on a consolidated basis and
included Cipher Pharmaceuticals Inc. (the "Company") and its wholly-
owned subsidiaries Cipher Canada Inc., Cipher Holdings (Barbados)
Ltd. and Cipher Pharmaceuticals Ltd. There was no activity in the
three wholly-owned subsidiaries during 2008 and on October 31, 2008
the three companies were wound up by way of voluntary dissolution.
Significant accounting policies used in the preparation of these
financial statements are as follows:
Translation of foreign currencies
Revenues and expenses denominated in foreign currencies are
translated into Canadian dollars using the exchange rate in effect at
the transaction date. Monetary assets and liabilities are translated
using the rate in effect at the balance sheet date and non-monetary
items are translated at historical exchange rates. Related exchange
gains and losses are included in the determination of the loss for
the year.
Use of estimates
The preparation of these financial statements requires management to
make estimates and assumptions that could affect the reported amounts
of assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting
periods presented. Significant areas requiring the use of management
estimates include intangible assets and income taxes. By their
nature, these estimates are subject to measurement uncertainty.
Actual results could differ from the estimates and assumptions.
Property and equipment
Property and equipment are recorded at cost less accumulated
amortization. Amortization is computed using the straight-line method
using the following estimated useful lives of the assets or lease
terms:
Computer equipment 3 years
Computer software 3 years
Furniture and fixtures 5 years
Leasehold improvements over the term of the lease
Impairment of long-lived assets
Long-lived assets are tested for recoverability whenever events or
changes in circumstances indicate the carrying value may not be
recoverable. An impairment loss is recognized when the carrying
amount of a long-lived asset exceeds the sum of the estimated
undiscounted cash flows from the long-lived asset. An impairment loss
is measured as the amount by which the carrying amount of the long-
lived asset exceeds the estimated fair value.
Intangible assets
Intangible assets consist of marketing and other rights relating to
products and are initially recorded at cost. Intangible assets have a
finite life and are amortized using the straight-line method over
their estimated period of useful life, which is determined to be 3.5
years from the date of regulatory (generally, U.S. Food and Drug
Administration ("FDA")) approval for marketing the related product.
Intangible assets are reviewed for impairment when events or other
changes in circumstances indicate that the carrying amount of the
assets may not be recoverable.
Revenue recognition
The Company recognizes revenue from product sales contracts and
licensing and distribution agreements, which may include multiple
elements. The individual elements of each agreement are divided into
separate units of accounting, if certain criteria are met. The
applicable revenue recognition approach is then applied to each unit.
Otherwise, the applicable revenue recognition criteria are applied to
combined elements as a single unit of accounting.
Product sales - revenue from product sales contracts is recognized
when the product is shipped to the Company's customers, at which time
ownership is transferred.
Licensing revenues - for up-front licensing payments and pre-
commercialization milestones, revenue is deferred and recognized on a
straight-line basis over the estimated term that the Company
maintains substantive contractual obligations. Post-commercialization
milestone payments are recognized as revenue when the underlying
condition is met, the milestone is not a condition to future
deliverables and collectibility is reasonably assured. Otherwise,
these milestone payments are recognized as revenue over the remaining
term of the underlying agreement or the term over which the Company
maintains substantive contractual obligations. Royalty revenue is
recognized in the period in which the Company earns the royalty.
Amounts received in advance of recognition as revenue are included in
deferred revenue. Revenue from licensing and distribution agreements
is presented on a net basis.
Research and development
The Company conducts various research and development programs and
incurs costs related to these activities, including employee
compensation, materials, professional services and services provided
by contract research organizations. Research and development costs,
net of related tax credits, are expensed in the periods in which they
are incurred.
Income taxes
The Company uses the asset and liability method of accounting for
income taxes. Under this method, future tax assets and liabilities
are determined based on differences between the financial reporting
and income tax bases of assets and liabilities and are measured using
enacted or substantively enacted tax rates and laws that will be in
effect when the difference is expected to reverse. The Company
provides a valuation allowance for future tax assets when it is more
likely than not that some or all of the future tax assets will not be
realized.
Stock-based compensation
The fair value of stock options granted after October 1, 2002 is
recognized as compensation expense on a straight-line basis over the
applicable stock option vesting period. Stock-based compensation
expense is included in operating, general and administrative expense
in the statements of operations and contributed surplus in the
balance sheets. The consideration received on the exercise of stock
options is credited to share capital at the time of exercise.
Financial instruments
Financial instruments are measured at fair value except for loans and
receivables, held-to-maturity investments and other financial
liabilities, which are measured at cost or amortized cost. Gains and
losses on held-for-trading financial assets and liabilities are
recognized in net earnings in the period in which they arise.
Unrealized gains and losses, including changes in foreign exchange
rates on available-for-sale financial assets, are recognized in
comprehensive income until the financial assets are derecognized or
impaired, at which time any unrealized gains or losses are recorded
in net earnings.
The following is the basis of classification and measurement of the
Company's financial instruments:
- Cash is classified as held-for-trading and is measured at fair
value;
- Accounts receivable and loan receivable are classified as loans
and receivables and recorded at cost, which at initial
measurement corresponds to fair value. After initial fair value
measurement, they are measured at amortized cost; and
- Accounts payable and accrued liabilities are classified as other
financial liabilities. They are initially measured at fair value
and, if necessary, subsequent revaluations are recorded at
amortized cost.
2 ADOPTION OF NEW ACCOUNTING POLICIES
Effective January 1, 2008, the Company adopted the following new CICA
accounting standards: Section 3862, Financial Instruments -
Disclosures and Section 1535, Capital Disclosures.
CICA Section 3862, Financial Instruments - Disclosures, establishes
standards for the disclosure of financial instruments including
disclosing the significance of financial instruments and the nature
and extent of risks arising from financial instruments.
CICA Section 1535, Capital Disclosures, establishes standards for
disclosing aspects of the entity's capital management strategy. This
standard requires disclosure of both quantitative and qualitative
disclosures around the entity's objectives, policies and processes
for managing capital requirements and the consequences of non-
compliance.
The adoption of these new standards had no impact on the Company's
financial position or results of operations.
3 RISK MANAGEMENT
Financial risk management
In the normal course of business, the Company is exposed to a number
of financial risks that can affect its operating performance. These
risks are: credit risk, liquidity risk and market risk. The Company's
overall risk management program and prudent business practices
seek to minimize any potential adverse affects on the Company's
financial performance.
(i) Credit risk
Accounts receivable - the Company licenses its products to
distribution partners in major markets. The credit risk associated
with the accounts receivable pursuant to these agreements is
evaluated during initial negotiations and on an ongoing basis. There
have been no events of default under these agreements. As of
December 31, 2008, no accounts receivable balances were considered
impaired and $32 was considered past due.
Loan receivable - the loan receivable is repaid in annual instalments
over a five year period, with two instalments remaining as at
December 31, 2008. All prior instalments have been received on
schedule and there have been no events of default under the loan
agreement.
(ii) Liquidity risk
The Company has no long term debt with specified repayment terms.
Accounts payable and accrued liabilities are settled in the regular
course of business, based on negotiated terms with trade suppliers.
All components of the balance of $1,178 as at December 31, 2008 will
be settled in less than one year. The carrying value of the balances
approximate their fair value as the impact of discounting is not
significant.
(iii) Market risk
Currency risk - the majority of the Company's revenue and a portion
of its expenses are denominated in US currency. At December 31, 2008
the accounts receivable balance includes a total of US$338 and
accounts payable and accrued liabilities includes a total of US$478.
There is no active hedging program currently in place due to the
relatively short time frame for settlement of these balances. A 10%
change in the US/CDN exchange rate on the December 31, 2008 balances
would have had a $14 impact on net income.
Interest rate risk - the fair value of the loan receivable is based
upon a discounted cash flow method, whereby a risk premium is added
to the Bank of Canada risk-free interest rate. A 10% change in the
risk-free interest rate would not have had a significant impact on
imputed interest.
Capital risk management
Shareholders' equity is managed as the capital of the Company. The
Company's objective when managing capital is to safeguard its ability
to continue as a going concern in order to provide returns for
shareholders and to maintain an optimal capital structure to minimize
the cost of capital. In order to maintain or adjust the capital
structure, the Company may issue new common shares from time to time.
4 PROPERTY AND EQUIPMENT
The following is a summary of property and equipment as at
December 31, 2008:
December 31, 2008 December 31, 2007
---------------------------------------------------------------------
Accumulated Accumulated
Cost Amortization Cost Amortization
---------------------------------------------------------------------
Computer equipment $ 101 $ 79 $ 91 $ 58
Computer software 35 24 35 14
Furniture and fixtures 126 58 126 31
Leasehold improvements 67 21 67 8
---------------------------------------------
329 $ 182 319 $ 111
Accumulated amortization (182) (111)
---------------------------------------------------------------------
$ 147 $ 208
---------------------------------------------------------------------
---------------------------------------------------------------------
5 LOAN RECEIVABLE
On February 28, 2005, the Company completed the sale of its wholly-
owned pharmaceutical research services business, Pharma Medica
Research Inc. (Pharma Medica). Consideration consisted of a cash
payment of $14,000 and a deferred payment of $4,000. The deferred
payment is non-interest bearing and is repayable in annual
instalments of $800 over a five year period. As the deferred payment
is non-interest bearing, it was recorded at its fair value of $3,112
based on a discount rate of 9%. Imputed interest of $136 has been
recorded on this deferred payment during the year ended December 31,
2008 ($191 during the year ended December 31, 2007). In accordance
with the terms of the deferred payment agreement, $800 of clinical
services purchased from Pharma Medica during 2007 were offset against
the annual payment that was due on January 30, 2008. During the year
ended December 31, 2008, $188 of clinical services purchased from
Pharma Medica have been offset against the next annual payment, which
is due on January 30, 2009.
6 INTANGIBLE ASSETS
During fiscal 2001, the Company entered into certain agreements with
Galephar Pharmaceutical Research Inc. ("Galephar") for the rights to
package, test, obtain regulatory approvals and market certain
products in various countries around the world. In accordance with
the terms of the agreements, the Company has acquired these
intangible rights through an investment in three separate series of
preferred shares of Galephar. The Company may be required to pay
additional amounts to Galephar in respect of the CIP-ISOTRETINOIN and
CIP-TRAMADOL ER intangible rights of up to $1,837 (US$1,500) if
certain future milestones are achieved as defined in the agreements.
These additional payments will be made in the form of additional
Galephar preferred share purchases. The recoverability of these
intangible rights is dependant upon sufficient revenues being
generated from the related products currently under development and
commercialization.
Upon receipt of FDA approval in January 2006, the Company began
amortizing the intangible rights related to CIP-FENOFIBRATE. As at
December 31, 2008, no other products have received FDA approval.
With regard to CIP-FENOFIBRATE, in July 2007 the Company entered into
a licensing and distribution agreement with Kowa Pharmaceuticals
America, Inc. ("Kowa"), formerly ProEthic Pharmaceuticals, Inc.,
under which Kowa was granted the exclusive right to market, sell and
distribute Lipofen in the United States. The Company received an up-
front licensing payment of US$2 million and, under the terms of the
agreement, could receive additional milestone payments of up to
US$20 million based on the achievement of certain net sales targets.
The Company also receives a royalty based on a percentage of net
sales. These elements are reflected in licensing revenue, which also
incorporates direct product-related expenses and amounts due to
Galephar, the Company's technology partner. Revenue from licensing
and distribution agreements is presented on a net basis. After
product-related expenses are deducted, approximately 50% of all
milestone and royalty payments received by the Company under the
agreement will be paid to Galephar. Lipofen was launched in the U.S.
market in September 2007.
The Company's US$2 million investment in Galephar preferred shares
related to CIP-FENOFIBRATE is being repaid by Galephar in a series of
quarterly payments. A total of US$800 has been received as at
December 31, 2008 and a further amount of US$199 was offset against
amounts owing to Galephar. These amounts are included in revenue over
the same period as up-front licensing payments are recognized.
In August 2008, the Company entered into a development, distribution
and supply agreement with Ranbaxy Pharmaceuticals Inc. ("Ranbaxy")
under which Ranbaxy was granted the exclusive right to market, sell
and distribute CIP-ISOTRETINOIN in the United States. Under the terms
of the agreement, the Company received an up-front licensing payment
of US$1 million and could receive additional pre- and post-
commercialization milestone payments of up to US$23 million, based on
the achievement of certain milestone targets. Once the product is
successfully commercialized, the Company will also receive a royalty
based on a percentage of net sales. In addition, Ranbaxy will
reimburse the Company for all costs associated with the clinical
studies required by the FDA to secure NDA approval, up to a
predetermined cap. Any additional development costs associated with
initial FDA approval will be shared equally. The Company is
responsible for all product development activities, including
management of the clinical studies required by the FDA to secure NDA
approval and is also responsible for product supply and
manufacturing, which will be fulfilled by Galephar. After product-
related expenses are deducted, approximately 50% of all milestone and
royalty payments received by the Company under the agreement will be
paid to Galephar.
The following is a summary of intangible assets as at December 31,
2008:
December 31, 2008 December 31, 2007
---------------------------------------------------------------------
Accumulated Accumulated
Amortization Amortization
Cost and Writedowns Cost and Writedowns
---------------------------------------------------------------------
CIP-FENOFIBRATE $ 3,014 $ 2,080 $ 3,014 $ 1,614
CIP-ISOTRETINOIN 1,883 426 1,883 426
CIP-TRAMADOL ER 2,161 426 2,161 426
------------------------------------------------
7,058 $ 2,932 7,058 $ 2,466
Accumulated
amortization and
writedowns (2,932) (2,466)
---------------------------------------------------------------------
$ 4,126 $ 4,592
---------------------------------------------------------------------
---------------------------------------------------------------------
7 SHARE CAPITAL
Authorized share capital
The authorized share capital consists of an unlimited number of
preference shares, issuable in series, and an unlimited number of
voting common shares.
Issued share capital
The following is a summary of the changes in share capital from
December 31, 2006 to December 31, 2008:
Number of
common shares Amount
(in thousands) $
Balance outstanding - December 31, 2006 24,036 49,891
Options exercised during 2007 19 57
--------------------------
Balance outstanding - December 31, 2007
and December 31, 2008 24,055 49,948
--------------------------
--------------------------
Stock option plan
The following is a summary of the changes in the stock options
outstanding from December 31, 2006 to December 31, 2008:
Weighted
average
Number of exercise
options price
(in thousands) $
Balance outstanding - December 31, 2006 889 2.96
Options granted during 2007 274 3.90
Options exercised during 2007 (38) 1.90
Options cancelled during 2007 (127) 2.16
---------------
Balance outstanding - December 31, 2007 998 3.36
Options granted during 2008 483 0.78
Options that expired or were
cancelled during 2008 (105) 2.55
---------------
Balance outstanding - December 31, 2008 1,376 2.51
---------------
---------------
At December 31, 2008, 540,482 options were fully vested and
exercisable (309,741 at December 31, 2007).
During 2008, the Company issued 483,000 stock options under the
employee and director stock option plan, with exercise prices ranging
from $0.45 to $1.05, 25% of which vest on either February 28,
November 7 or December 3 of each year for the next four years,
commencing in 2009, and all of which expire in 2018. Total
compensation cost for these stock options is estimated to be $334.
This cost will be recognized over the vesting period of the stock
options.
The stock options issued during 2008 were valued using the Black-
Scholes option pricing model with the following assumptions:
Risk-free interest rate 2.27% - 3.14%
Expected life 10 years
Expected volatility 93% - 102%
Expected dividend Nil
The following is a summary of the outstanding options as at
December 31, 2008:
Expiry date Exercise Number of options (in thousands)
price --------------------------------------
$ Vested Unvested Total
January 11, 2012 1.09 125 - 125
September 17, 2014 2.35 125 - 125
March 23, 2016 4.12 100 100 200
June 28, 2016 4.00 90 90 180
August 8, 2016 4.33 10 10 20
September 13, 2016 2.90 34 35 69
March 9, 2017 3.90 56 168 224
February 28, 2018 1.05 - 213 213
November 7, 2018 0.45 - 180 180
December 3, 2018 0.50 - 40 40
--------------------------------------
540 836 1,376
--------------------------------------
--------------------------------------
8 CONTRIBUTED SURPLUS
The following is a summary of the changes in contributed surplus from
December 31, 2006 to December 31, 2008:
Amount
$
Balance - December 31, 2006 30,430
Options exercised during 2007 (57)
Stock-based compensation expense during 2007 659
------------
Balance - December 31, 2007 31,032
Stock-based compensation expense during 2008 581
------------
Balance - December 31, 2008 31,613
------------
------------
9 RESEARCH AND DEVELOPMENT
A total of $2,242 of research and development costs were incurred in
2008 ($2,926 in 2007). The research and development expense reflected
in the Statement of Operations is presented net of Ontario Innovation
Tax Credit ("OITC") program credits of $440 for qualifying research
and development expenditures for 2006 through 2008 and an amount of
$499 reimbursed by Ranbaxy. Under the terms of the agreement with
Ranbaxy, research and development costs incurred for clinical studies
required by the FDA to secure approval for CIP-ISOTRETINOIN are
reimbursed to the Company and as a result, there was a nil impact to
research and development expense with respect to these costs. There
were no OITC credits or reimbursements recorded in 2007.
10 RECOVERY OF LEGAL FEES AND COURT COSTS
On July 30, 2008, the Federal Court of Canada ruled in the Company's
favour and awarded a recovery of legal fees and court costs from
prior years in the amount of $176.
11 INCOME TAXES
The provision for income taxes differs from the amount computed by
applying the statutory income tax rate to the loss for the year. The
sources and tax effects of the differences are as follows:
For the year ended
December 31,
2008 2007
$ $
Statutory income tax rate of 33.5% applied
to loss for the year (2007 - 36.12%) (1,082) (2,328)
Permanent differences 57 253
Change in enacted income tax rates
and other items (599) (1,670)
Change in valuation allowance 1,624 3,745
-----------------------
Provision for income taxes - -
-----------------------
-----------------------
The significant components of future income tax assets are summarized
as follows:
As at
December 31,
2008 2007
$ $
Non-capital losses 10,776 9,864
Excess of tax value of property and
equipment over book value 49 27
SR&ED expenditure pool 3,466 3,206
Excess of tax value of intangible assets
over book value 7,581 7,513
Benefit of investment tax credits 2,057 1,694
Capital losses 93 -
Deductible share issue costs 127 190
Other temporary differences 487 518
-----------------------
24,636 23,012
Valuation allowance (24,636) (23,012)
-----------------------
- -
-----------------------
-----------------------
The Company has non-capital loss carry forwards of $37,200 as at
December 31, 2008 that expire in varying amounts from 2014 to 2028.
The Company has Scientific Research and Experimental Development
("SR&ED") expenditures of $11,900 which can be carried forward
indefinitely to reduce future years' taxable income.
The Company has approximately $2,600 of investment tax credits on
SR&ED expenditures that are available to be applied against federal
taxes otherwise payable in future years and expire in varying amounts
from 2013 to 2028.
12 LOSS PER SHARE
Loss per share is calculated using the weighted average number of
shares outstanding. The weighted average number of shares outstanding
for the year ended December 31, 2008 was 24,054,878 (for the year
ended December 31, 2007 - 24,049,174).
As the Company had a loss for each of the periods presented, basic
and diluted loss per share are the same because the exercise of all
stock options would have an anti-dilutive effect.
13 SUPPLEMENTAL CASH FLOW INFORMATION
The following is a summary of the changes in non-cash operating
items:
For the year ended
December 31,
2008 2007
$ $
Accounts receivable 884 (1,236)
Income taxes receivable 122 (33)
Prepaid expenses and other current assets (324) (24)
Accounts payable and accrued liabilities 119 15
Deferred revenue 189 1,982
-----------------------
990 704
-----------------------
-----------------------
14 COMPARATIVE FIGURES
Certain comparative figures for the previous year have been
reclassified to conform to current financial statement presentation.
For further information
Craig Armitage, Investor Relations, The Equicom Group, (416) 815-0700 ext 278, (416) 815-0080 fax, carmitage@equicomgroup.com
Larry Andrews, President and CEO, Cipher Pharmaceuticals, (905) 602-5840 ext 324, (905) 602-0628 fax, landrews@cipherpharma.com
--------------------------------------------------------------------------------
Source: Cipher Pharmaceuticals Inc.
Press Release Source: Cipher Pharmaceuticals Inc.
Cipher reports Q1 2009 financial results
On Wednesday May 13, 2009, 7:00 am EDT
Buzz up! Print.
Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, May 13 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND - News) today announced its financial and operational results for the three months ended March 31, 2009.
Q1 2009 Summary
----------------
- Received tentative U.S. Food and Drug Administration ("FDA") approval
for CIP-TRAMADOL ER for distribution in the United States.
- Total revenue of $0.6 million, driven by growing sales of Lipofen(R)
and contribution from the CIP-ISOTRETINOIN licensing agreement.
- Solid balance sheet at quarter end with cash of $9.1 million and no
debt.
- Subsequent to quarter end, finalized FDA Special Protocol Assessment
("SPA") for CIP-ISOTRETINOIN Phase III safety trial.
"The first quarter was highlighted by tentative FDA approval of our extended-release tramadol product - an important regulatory milestone for the Company," said Larry Andrews, President and CEO of Cipher. "We were pleased with the continued steady growth of Lipofen prescriptions in the quarter as our partner Kowa expands its salesforce. With the CIP-ISOTRETINOIN study protocol now finalized, we look forward to beginning the trial in the coming months. We are also working diligently on new product in-licensing activity."
Financial Review
-----------------
Total revenue in Q1 2009 was $0.6 million, compared with $0.2 million in Q1 2008, driven by the continued market penetration of Lipofen(R) as Kowa expands its sales force.
Research and Development ("R&D") expenses for Q1 2009 were $0.2 million, a decrease of $0.2 million compared with the same period in 2008, which reflects the advanced stage of development of the Company's current products. Operating, General and Administrative ("OG&A") expenses for Q1 2009 were $1.0 million, compared with $0.8 million in Q1 2008. The increase reflects the addition of new business development resources late in 2008 to support the Company's in-licensing and out-licensing activities. The loss for the three months ended March 31, 2009 was $0.8 million ($0.03 per basic and diluted share), a decrease of 28% compared with the loss of $1.1 million ($0.04 per basic and diluted share) in Q1 2008. The improved performance was primarily a result of increased revenue generated from the Lipofen(R) U.S. distribution agreement and reduced R&D expenditures.
The Company's financial position remained solid at quarter end. As at March 31, 2009, Cipher had cash of $9.1 million, compared with $9.9 million as at December 31, 2008.
Product Update
---------------
During Q1 2009, Lipofen(R) monthly prescriptions showed steady growth, and Cipher expects this trend to continue as Kowa increases penetration of the primary care physicians in its targeted regions and expands its sales force. Since the Kowa acquisition, the number of sales reps has increased from approximately 65 to 140 at the end of April, with further increases planned in 2010.
During Q1 2009, Cipher and its advisors continued their dialogue and discussions with the FDA regarding the appropriate design of a Phase III safety trial for CIP-ISOTRETINOIN. Subsequent to quarter end, the Company finalized the study protocol under a Special Protocol Assessment ("SPA") and plans to begin trial enrolment in early Q3 2009.
During Q2 2008, Cipher submitted a revised NDA to the FDA for CIP-TRAMADOL ER, the Company's extended-release formulation of tramadol. In February 2009, the Company received tentative approval from the FDA. While the product meets all the FDA's requirements for manufacturing quality, clinical safety and efficacy, the Company must resolve certain patent issues associated with the reference product, Ultram(R) ER, before CIP-TRAMADOL ER is commercialized.
Cipher continues to actively pursue new pipeline products and advance out-licensing discussions for its current products.
Notice of Conference Call
--------------------------
Cipher will hold a conference call today, May 13, 2009, at 8:30 a.m. (ET) to discuss its financial results and other corporate developments. To access the conference call by telephone, dial 416-644-3424 or 1-800-731-5319. A live audio webcast of the call will be available at www.cipherpharma.com. The webcast will be archived for 90 days.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals is a drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies. Cipher's strategy is to in-license products that incorporate proven drug delivery technologies and advance them through the clinical development and regulatory approval stages, after which the products are out-licensed to international partners. Because Cipher's products are based on proven technology platforms applied to currently marketed drugs, they are expected to have lower approval risk, shorter development timelines and significantly lower development costs. The Company's lead compound, CIP-FENOFIBRATE, received final approval from the U.S. Food and Drug Administration and Health Canada in the first quarter of 2006. The product is being marketed in the United States by Kowa Pharmaceuticals America under the label Lipofen(R). In addition, Cipher is developing formulations of the pain reliever tramadol (tentative FDA approval in February 2009) and the acne treatment isotretinoin (FDA approvable letter in April 2007).
Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit www.cipherpharma.com.
Forward-Looking Statements
Statements made in this news release, other than those concerning historical financial information, may be forward-looking and therefore subject to various risks and uncertainties. Some forward-looking statements may be identified by words like "may", "will", "anticipate", "estimate", "expect", "intend", or "continue" or the negative thereof or similar variations. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. Factors that could cause results to vary include those identified in the Company's Annual Information Form and other filings with Canadian securities regulatory authorities, such as the applicability of patents and proprietary technology; possible patent litigation; regulatory approval of products in the Company's pipeline; changes in government regulation or regulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships for product candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals; intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability to access capital to fund R&D; and the ability to attract and retain key personnel. All forward-looking statements presented herein should be considered in conjunction with such filings. Except as required by Canadian securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.
Cipher Pharmaceuticals Inc.
Unaudited Balance Sheets
(in thousands of dollars)
As at
March 31, December 31,
2009 2008
ASSETS
Current assets
Cash $ 9,103 $ 9,881
Accounts receivable 754 512
Income taxes receivable 6 6
Prepaid expenses and other current assets 285 380
Current portion of loan receivable (note 2) 741 608
-------------------------------------------------------------------------
10,889 11,387
Property and equipment, net 128 147
Loan receivable - 717
Intangible assets, net (note 3) 4,060 4,126
-------------------------------------------------------------------------
-------------------------------------------------------------------------
$ 15,077 $ 16,377
-------------------------------------------------------------------------
-------------------------------------------------------------------------
LIABILITIES
Current liabilities
Accounts payable and accrued liabilities $ 595 $ 1,178
Current portion of deferred revenue 1,247 1,177
-------------------------------------------------------------------------
1,842 2,355
Deferred revenue 823 994
-------------------------------------------------------------------------
2,665 3,349
-------------------------------------------------------------------------
SHAREHOLDERS' EQUITY
Share capital (note 4) 49,948 49,948
Contributed surplus 31,774 31,613
Deficit (69,310) (68,533)
-------------------------------------------------------------------------
12,412 13,028
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------------------------------------------------
$ 15,077 $ 16,377
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these unaudited financial
statements
Cipher Pharmaceuticals Inc.
Unaudited Statements of Operations and Comprehensive Loss
(in thousands of dollars, except per share amounts)
For the three months ended
March 31, March 31,
2009 2008
Revenues
Licensing revenue $ 602 $ 177
-------------------------------------------------------------------------
Expenses
Research and development 229 450
Operating, general and administrative 989 811
Amortization of property and equipment 19 17
Amortization of intangible assets 188 117
Interest income (46) (138)
-------------------------------------------------------------------------
1,379 1,257
-------------------------------------------------------------------------
Loss and comprehensive loss for the period $ (777) $ (1,080)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per share (note 5) $ (0.03) $ (0.04)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these unaudited financial
statements
Cipher Pharmaceuticals Inc.
Unaudited Statements of Deficit
(in thousands of dollars)
For the three For the
months ended year ended
March 31, March 31, December 31,
2009 2008 2008
Deficit, beginning of period $ (68,533) $ (65,303) $ (65,303)
Loss for the period (777) (1,080) (3,230)
-------------------------------------------------------------------------
Deficit, end of period $ (69,310) $ (66,383) $ (68,533)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these unaudited financial
statements
Cipher Pharmaceuticals Inc.
Unaudited Statements of Cash Flows
(in thousands of dollars)
For the three months ended
March 31, March 31,
2009 2008
Cash provided by (used in)
Operating activities
Loss $ (777) $ (1,080)
Items not affecting cash
Amortization of property and equipment 19 17
Amortization of intangible assets 188 117
Stock-based compensation expense 161 117
Imputed interest (note 2) (28) (41)
-------------------------------------------------------------------------
(437) (870)
Net change in non-cash operating items (831) 179
-------------------------------------------------------------------------
(1,268) (691)
-------------------------------------------------------------------------
Investing activities
Proceeds from loan receivable (note 2) 612 -
Acquisition of intangible rights (note 3) (122) -
-------------------------------------------------------------------------
490 -
-------------------------------------------------------------------------
Decrease in cash (778) (691)
Cash, beginning of period 9,881 10,961
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Cash, end of period $ 9,103 $ 10,270
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these unaudited financial
statements
Cipher Pharmaceuticals Inc.
Notes to Unaudited Financial Statements
March 31, 2009
(in thousands of dollars, except per share amounts)
1 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of presentation
The accompanying unaudited interim financial statements of the Company
have been prepared in accordance with accounting principles generally
accepted in Canada for interim reporting. Accordingly, these financial
statements do not include all of the disclosures required by generally
accepted accounting principles for annual financial statements and should
be read in conjunction with the annual financial statements of the
Company. In the opinion of management, all adjustments considered
necessary for fair presentation have been included. All such adjustments
are of a normal recurring nature. Operating results for the three months
ended March 31, 2009 are not necessarily indicative of the results that
may be expected for the fiscal year ending December 31, 2009.
There have been no changes to the accounting policies as described in
Note 1 and Note 2 to the financial statements for the year ended December
31, 2008.
2 LOAN RECEIVABLE
On February 28, 2005, the Company completed the sale of its wholly-owned
pharmaceutical research services business, Pharma Medica Research Inc.
(Pharma Medica). Consideration consisted of a cash payment of $14,000 and
a deferred payment of $4,000. The deferred payment is non-interest
bearing and is repayable in annual instalments of $800 over a five year
period. As the deferred payment is non-interest bearing, it was recorded
at its fair value of $3,112 based on a discount rate of 9%. Imputed
interest of $28 has been recorded on this deferred payment during the
three months ended March 31, 2009 ($41 during the three months ended
March 31, 2008). In accordance with the terms of the deferred payment
agreement, $188 of clinical services purchased from Pharma Medica in 2008
were offset against the annual instalment received on January 30, 2009.
3 INTANGIBLE ASSETS
During fiscal 2001, the Company entered into certain agreements with
Galephar Pharmaceutical Research Inc. ("Galephar") for the rights to
package, test, obtain regulatory approvals and market certain products in
various countries around the world. In accordance with the terms of the
agreements, the Company has acquired these intangible rights through an
investment in three separate series of preferred shares of Galephar. The
Company may be required to pay additional amounts to Galephar in respect
of the CIP-ISOTRETINOIN and CIP-TRAMADOL ER intangible rights of up to
$1,764 (US$1,400) if certain future milestones are achieved as defined in
the agreements. These additional payments will be made in the form of
additional Galephar preferred share purchases. The recovery of these
intangible rights is dependant upon sufficient revenues being generated
from the related products currently under development and
commercialization. The Company is currently amortizing the intangible
rights related to CIP-FENOFIBRATE and CIP-ISOTRETINOIN.
With regard to CIP-FENOFIBRATE, in July 2007 the Company entered into a
licensing and distribution agreement with Kowa Pharmaceuticals America,
Inc. ("Kowa"), under which Kowa was granted the exclusive right to
market, sell and distribute Lipofen in the United States. The Company
received an up-front licensing payment of US$2 million and, under the
terms of the agreement, could receive additional milestone payments of up
to US$20 million based on the achievement of certain net sales targets.
The Company also receives a royalty based on a percentage of net sales.
These elements are reflected in licensing revenue, which also
incorporates product-related expenses and amounts due to Galephar, the
Company's technology partner. Revenue from licensing and distribution
agreements is presented on a net basis. After product-related expenses
are deducted, approximately 50% of all milestone and royalty payments
received by the Company under the agreement will be paid to Galephar.
Lipofen was launched in the U.S. market in 2007.
In August 2008, the Company entered into a development, distribution and
supply agreement with Ranbaxy Pharmaceuticals Inc. ("Ranbaxy") under
which Ranbaxy was granted the exclusive right to market, sell and
distribute CIP-ISOTRETINOIN in the United States. Under the terms of the
agreement, the Company received an up-front licensing payment of US$1
million and could receive additional pre- and post-commercialization
milestone payments of up to US$23 million, based on the achievement of
certain milestone targets. Once the product is commercialized, the
Company will also receive a royalty based on a percentage of net sales.
In addition, Ranbaxy will reimburse the Company for all costs associated
with the clinical studies required by the FDA to secure NDA approval, up
to a predetermined cap. Any additional development costs associated with
initial FDA approval will be shared equally. The Company is responsible
for all product development activities, including management of the
clinical studies required by the FDA to secure NDA approval and is also
responsible for product supply and manufacturing, which will be fulfilled
by Galephar. After product-related expenses are deducted, approximately
50% of all milestone and royalty payments received by the Company under
the agreement will be paid to Galephar.
4 SHARE CAPITAL
Authorized share capital
The authorized share capital consists of an unlimited number of shares,
issuable in series, and an unlimited number of voting common shares.
Issued share capital
There have been no changes in the Company's share capital during the
period from December 31, 2007 to March 31, 2009. The following is a
summary of the Company's share capital as at March 31, 2009:
Number of
common shares Amount
(in thousands) $
Balance outstanding - March 31, 2009 24,055 49,948
-----------------------------
-----------------------------
Stock option plan
The following is a summary of the changes in the stock options
outstanding from December 31, 2007 to March 31, 2009:
Weighted
average
Number of exercise
options price
(in thousands) $
Balance outstanding - December 31, 2007 998 3.36
Options granted during 2008 483 0.78
Options that expired or were cancelled
during 2008 (105) 2.55
--------------
Balance outstanding - December 31, 2008 1,376 2.51
Options granted during the three months
ended March 31, 2009 204 0.61
--------------
Balance outstanding - March 31, 2009 1,580 2.27
--------------
--------------
At March 31, 2009, 721,974 options were fully vested and exercisable
(500,418 at March 31, 2008).
During the three months ended March 31, 2009, the Company issued 204,375
stock options under the employee and director stock option plan, which
have an exercise price of $0.61, 25% of which vest on February 20 of each
year, commencing in 2010, and expire in 2019. Total compensation cost for
these stock options is estimated to be $114. This cost will be recognized
over the vesting period of the stock options.
The stock options issued during the three months ended March 31, 2009
were valued using the Black-Scholes option pricing model with the
following assumptions:
Risk-free interest rate 3.14%
Expected life 10 years
Expected volatility 99%
Expected dividend Nil
5 LOSS PER SHARE
Loss per share is calculated using the weighted average number of shares
outstanding. The weighted average number of shares outstanding for the
three months ended March 31, 2009 and March 31, 2008 was 24,054,878.
As the Company had a loss for each of the periods presented, basic and
diluted loss per share are the same because the exercise of all stock
options would have an anti-dilutive effect.
For further information
Craig Armitage, Investor Relations, The Equicom Group, (416) 815-0700 ext 278, (416) 815-0080 fax, carmitage@equicomgroup.com
Larry Andrews, President and CEO, Cipher Pharmaceuticals, (905) 602-5840 ext 324, (905) 602-0628 fax, landrews@cipherpharma.com
Cipher reports Q1 2009 financial results
On Wednesday May 13, 2009, 7:00 am EDT
Buzz up! Print.
Toronto Stock Exchange Symbol: DND
MISSISSAUGA, ON, May 13 /CNW/ - Cipher Pharmaceuticals Inc. (TSX: DND - News) today announced its financial and operational results for the three months ended March 31, 2009.
Q1 2009 Summary
----------------
- Received tentative U.S. Food and Drug Administration ("FDA") approval
for CIP-TRAMADOL ER for distribution in the United States.
- Total revenue of $0.6 million, driven by growing sales of Lipofen(R)
and contribution from the CIP-ISOTRETINOIN licensing agreement.
- Solid balance sheet at quarter end with cash of $9.1 million and no
debt.
- Subsequent to quarter end, finalized FDA Special Protocol Assessment
("SPA") for CIP-ISOTRETINOIN Phase III safety trial.
"The first quarter was highlighted by tentative FDA approval of our extended-release tramadol product - an important regulatory milestone for the Company," said Larry Andrews, President and CEO of Cipher. "We were pleased with the continued steady growth of Lipofen prescriptions in the quarter as our partner Kowa expands its salesforce. With the CIP-ISOTRETINOIN study protocol now finalized, we look forward to beginning the trial in the coming months. We are also working diligently on new product in-licensing activity."
Financial Review
-----------------
Total revenue in Q1 2009 was $0.6 million, compared with $0.2 million in Q1 2008, driven by the continued market penetration of Lipofen(R) as Kowa expands its sales force.
Research and Development ("R&D") expenses for Q1 2009 were $0.2 million, a decrease of $0.2 million compared with the same period in 2008, which reflects the advanced stage of development of the Company's current products. Operating, General and Administrative ("OG&A") expenses for Q1 2009 were $1.0 million, compared with $0.8 million in Q1 2008. The increase reflects the addition of new business development resources late in 2008 to support the Company's in-licensing and out-licensing activities. The loss for the three months ended March 31, 2009 was $0.8 million ($0.03 per basic and diluted share), a decrease of 28% compared with the loss of $1.1 million ($0.04 per basic and diluted share) in Q1 2008. The improved performance was primarily a result of increased revenue generated from the Lipofen(R) U.S. distribution agreement and reduced R&D expenditures.
The Company's financial position remained solid at quarter end. As at March 31, 2009, Cipher had cash of $9.1 million, compared with $9.9 million as at December 31, 2008.
Product Update
---------------
During Q1 2009, Lipofen(R) monthly prescriptions showed steady growth, and Cipher expects this trend to continue as Kowa increases penetration of the primary care physicians in its targeted regions and expands its sales force. Since the Kowa acquisition, the number of sales reps has increased from approximately 65 to 140 at the end of April, with further increases planned in 2010.
During Q1 2009, Cipher and its advisors continued their dialogue and discussions with the FDA regarding the appropriate design of a Phase III safety trial for CIP-ISOTRETINOIN. Subsequent to quarter end, the Company finalized the study protocol under a Special Protocol Assessment ("SPA") and plans to begin trial enrolment in early Q3 2009.
During Q2 2008, Cipher submitted a revised NDA to the FDA for CIP-TRAMADOL ER, the Company's extended-release formulation of tramadol. In February 2009, the Company received tentative approval from the FDA. While the product meets all the FDA's requirements for manufacturing quality, clinical safety and efficacy, the Company must resolve certain patent issues associated with the reference product, Ultram(R) ER, before CIP-TRAMADOL ER is commercialized.
Cipher continues to actively pursue new pipeline products and advance out-licensing discussions for its current products.
Notice of Conference Call
--------------------------
Cipher will hold a conference call today, May 13, 2009, at 8:30 a.m. (ET) to discuss its financial results and other corporate developments. To access the conference call by telephone, dial 416-644-3424 or 1-800-731-5319. A live audio webcast of the call will be available at www.cipherpharma.com. The webcast will be archived for 90 days.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticals is a drug development company focused on commercializing novel formulations of successful, currently marketed molecules using advanced drug delivery technologies. Cipher's strategy is to in-license products that incorporate proven drug delivery technologies and advance them through the clinical development and regulatory approval stages, after which the products are out-licensed to international partners. Because Cipher's products are based on proven technology platforms applied to currently marketed drugs, they are expected to have lower approval risk, shorter development timelines and significantly lower development costs. The Company's lead compound, CIP-FENOFIBRATE, received final approval from the U.S. Food and Drug Administration and Health Canada in the first quarter of 2006. The product is being marketed in the United States by Kowa Pharmaceuticals America under the label Lipofen(R). In addition, Cipher is developing formulations of the pain reliever tramadol (tentative FDA approval in February 2009) and the acne treatment isotretinoin (FDA approvable letter in April 2007).
Cipher is listed on the Toronto Stock Exchange under the symbol 'DND' and has approximately 24 million shares outstanding. For more information, please visit www.cipherpharma.com.
Forward-Looking Statements
Statements made in this news release, other than those concerning historical financial information, may be forward-looking and therefore subject to various risks and uncertainties. Some forward-looking statements may be identified by words like "may", "will", "anticipate", "estimate", "expect", "intend", or "continue" or the negative thereof or similar variations. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. Factors that could cause results to vary include those identified in the Company's Annual Information Form and other filings with Canadian securities regulatory authorities, such as the applicability of patents and proprietary technology; possible patent litigation; regulatory approval of products in the Company's pipeline; changes in government regulation or regulatory approval processes; government and third-party payer reimbursement; dependence on strategic partnerships for product candidates and technologies, marketing and R&D services; meeting projected drug development timelines and goals; intensifying competition; rapid technological change in the pharmaceutical industry; anticipated future losses; the ability to access capital to fund R&D; and the ability to attract and retain key personnel. All forward-looking statements presented herein should be considered in conjunction with such filings. Except as required by Canadian securities laws, the Company does not undertake to update any forward-looking statements; such statements speak only as of the date made.
Cipher Pharmaceuticals Inc.
Unaudited Balance Sheets
(in thousands of dollars)
As at
March 31, December 31,
2009 2008
ASSETS
Current assets
Cash $ 9,103 $ 9,881
Accounts receivable 754 512
Income taxes receivable 6 6
Prepaid expenses and other current assets 285 380
Current portion of loan receivable (note 2) 741 608
-------------------------------------------------------------------------
10,889 11,387
Property and equipment, net 128 147
Loan receivable - 717
Intangible assets, net (note 3) 4,060 4,126
-------------------------------------------------------------------------
-------------------------------------------------------------------------
$ 15,077 $ 16,377
-------------------------------------------------------------------------
-------------------------------------------------------------------------
LIABILITIES
Current liabilities
Accounts payable and accrued liabilities $ 595 $ 1,178
Current portion of deferred revenue 1,247 1,177
-------------------------------------------------------------------------
1,842 2,355
Deferred revenue 823 994
-------------------------------------------------------------------------
2,665 3,349
-------------------------------------------------------------------------
SHAREHOLDERS' EQUITY
Share capital (note 4) 49,948 49,948
Contributed surplus 31,774 31,613
Deficit (69,310) (68,533)
-------------------------------------------------------------------------
12,412 13,028
-------------------------------------------------------------------------
-------------------------------------------------------------------------
-------------------------------------------------------------------------
$ 15,077 $ 16,377
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these unaudited financial
statements
Cipher Pharmaceuticals Inc.
Unaudited Statements of Operations and Comprehensive Loss
(in thousands of dollars, except per share amounts)
For the three months ended
March 31, March 31,
2009 2008
Revenues
Licensing revenue $ 602 $ 177
-------------------------------------------------------------------------
Expenses
Research and development 229 450
Operating, general and administrative 989 811
Amortization of property and equipment 19 17
Amortization of intangible assets 188 117
Interest income (46) (138)
-------------------------------------------------------------------------
1,379 1,257
-------------------------------------------------------------------------
Loss and comprehensive loss for the period $ (777) $ (1,080)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Basic and diluted loss per share (note 5) $ (0.03) $ (0.04)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these unaudited financial
statements
Cipher Pharmaceuticals Inc.
Unaudited Statements of Deficit
(in thousands of dollars)
For the three For the
months ended year ended
March 31, March 31, December 31,
2009 2008 2008
Deficit, beginning of period $ (68,533) $ (65,303) $ (65,303)
Loss for the period (777) (1,080) (3,230)
-------------------------------------------------------------------------
Deficit, end of period $ (69,310) $ (66,383) $ (68,533)
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these unaudited financial
statements
Cipher Pharmaceuticals Inc.
Unaudited Statements of Cash Flows
(in thousands of dollars)
For the three months ended
March 31, March 31,
2009 2008
Cash provided by (used in)
Operating activities
Loss $ (777) $ (1,080)
Items not affecting cash
Amortization of property and equipment 19 17
Amortization of intangible assets 188 117
Stock-based compensation expense 161 117
Imputed interest (note 2) (28) (41)
-------------------------------------------------------------------------
(437) (870)
Net change in non-cash operating items (831) 179
-------------------------------------------------------------------------
(1,268) (691)
-------------------------------------------------------------------------
Investing activities
Proceeds from loan receivable (note 2) 612 -
Acquisition of intangible rights (note 3) (122) -
-------------------------------------------------------------------------
490 -
-------------------------------------------------------------------------
Decrease in cash (778) (691)
Cash, beginning of period 9,881 10,961
-------------------------------------------------------------------------
-------------------------------------------------------------------------
Cash, end of period $ 9,103 $ 10,270
-------------------------------------------------------------------------
-------------------------------------------------------------------------
The accompanying notes are an integral part of these unaudited financial
statements
Cipher Pharmaceuticals Inc.
Notes to Unaudited Financial Statements
March 31, 2009
(in thousands of dollars, except per share amounts)
1 SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of presentation
The accompanying unaudited interim financial statements of the Company
have been prepared in accordance with accounting principles generally
accepted in Canada for interim reporting. Accordingly, these financial
statements do not include all of the disclosures required by generally
accepted accounting principles for annual financial statements and should
be read in conjunction with the annual financial statements of the
Company. In the opinion of management, all adjustments considered
necessary for fair presentation have been included. All such adjustments
are of a normal recurring nature. Operating results for the three months
ended March 31, 2009 are not necessarily indicative of the results that
may be expected for the fiscal year ending December 31, 2009.
There have been no changes to the accounting policies as described in
Note 1 and Note 2 to the financial statements for the year ended December
31, 2008.
2 LOAN RECEIVABLE
On February 28, 2005, the Company completed the sale of its wholly-owned
pharmaceutical research services business, Pharma Medica Research Inc.
(Pharma Medica). Consideration consisted of a cash payment of $14,000 and
a deferred payment of $4,000. The deferred payment is non-interest
bearing and is repayable in annual instalments of $800 over a five year
period. As the deferred payment is non-interest bearing, it was recorded
at its fair value of $3,112 based on a discount rate of 9%. Imputed
interest of $28 has been recorded on this deferred payment during the
three months ended March 31, 2009 ($41 during the three months ended
March 31, 2008). In accordance with the terms of the deferred payment
agreement, $188 of clinical services purchased from Pharma Medica in 2008
were offset against the annual instalment received on January 30, 2009.
3 INTANGIBLE ASSETS
During fiscal 2001, the Company entered into certain agreements with
Galephar Pharmaceutical Research Inc. ("Galephar") for the rights to
package, test, obtain regulatory approvals and market certain products in
various countries around the world. In accordance with the terms of the
agreements, the Company has acquired these intangible rights through an
investment in three separate series of preferred shares of Galephar. The
Company may be required to pay additional amounts to Galephar in respect
of the CIP-ISOTRETINOIN and CIP-TRAMADOL ER intangible rights of up to
$1,764 (US$1,400) if certain future milestones are achieved as defined in
the agreements. These additional payments will be made in the form of
additional Galephar preferred share purchases. The recovery of these
intangible rights is dependant upon sufficient revenues being generated
from the related products currently under development and
commercialization. The Company is currently amortizing the intangible
rights related to CIP-FENOFIBRATE and CIP-ISOTRETINOIN.
With regard to CIP-FENOFIBRATE, in July 2007 the Company entered into a
licensing and distribution agreement with Kowa Pharmaceuticals America,
Inc. ("Kowa"), under which Kowa was granted the exclusive right to
market, sell and distribute Lipofen in the United States. The Company
received an up-front licensing payment of US$2 million and, under the
terms of the agreement, could receive additional milestone payments of up
to US$20 million based on the achievement of certain net sales targets.
The Company also receives a royalty based on a percentage of net sales.
These elements are reflected in licensing revenue, which also
incorporates product-related expenses and amounts due to Galephar, the
Company's technology partner. Revenue from licensing and distribution
agreements is presented on a net basis. After product-related expenses
are deducted, approximately 50% of all milestone and royalty payments
received by the Company under the agreement will be paid to Galephar.
Lipofen was launched in the U.S. market in 2007.
In August 2008, the Company entered into a development, distribution and
supply agreement with Ranbaxy Pharmaceuticals Inc. ("Ranbaxy") under
which Ranbaxy was granted the exclusive right to market, sell and
distribute CIP-ISOTRETINOIN in the United States. Under the terms of the
agreement, the Company received an up-front licensing payment of US$1
million and could receive additional pre- and post-commercialization
milestone payments of up to US$23 million, based on the achievement of
certain milestone targets. Once the product is commercialized, the
Company will also receive a royalty based on a percentage of net sales.
In addition, Ranbaxy will reimburse the Company for all costs associated
with the clinical studies required by the FDA to secure NDA approval, up
to a predetermined cap. Any additional development costs associated with
initial FDA approval will be shared equally. The Company is responsible
for all product development activities, including management of the
clinical studies required by the FDA to secure NDA approval and is also
responsible for product supply and manufacturing, which will be fulfilled
by Galephar. After product-related expenses are deducted, approximately
50% of all milestone and royalty payments received by the Company under
the agreement will be paid to Galephar.
4 SHARE CAPITAL
Authorized share capital
The authorized share capital consists of an unlimited number of shares,
issuable in series, and an unlimited number of voting common shares.
Issued share capital
There have been no changes in the Company's share capital during the
period from December 31, 2007 to March 31, 2009. The following is a
summary of the Company's share capital as at March 31, 2009:
Number of
common shares Amount
(in thousands) $
Balance outstanding - March 31, 2009 24,055 49,948
-----------------------------
-----------------------------
Stock option plan
The following is a summary of the changes in the stock options
outstanding from December 31, 2007 to March 31, 2009:
Weighted
average
Number of exercise
options price
(in thousands) $
Balance outstanding - December 31, 2007 998 3.36
Options granted during 2008 483 0.78
Options that expired or were cancelled
during 2008 (105) 2.55
--------------
Balance outstanding - December 31, 2008 1,376 2.51
Options granted during the three months
ended March 31, 2009 204 0.61
--------------
Balance outstanding - March 31, 2009 1,580 2.27
--------------
--------------
At March 31, 2009, 721,974 options were fully vested and exercisable
(500,418 at March 31, 2008).
During the three months ended March 31, 2009, the Company issued 204,375
stock options under the employee and director stock option plan, which
have an exercise price of $0.61, 25% of which vest on February 20 of each
year, commencing in 2010, and expire in 2019. Total compensation cost for
these stock options is estimated to be $114. This cost will be recognized
over the vesting period of the stock options.
The stock options issued during the three months ended March 31, 2009
were valued using the Black-Scholes option pricing model with the
following assumptions:
Risk-free interest rate 3.14%
Expected life 10 years
Expected volatility 99%
Expected dividend Nil
5 LOSS PER SHARE
Loss per share is calculated using the weighted average number of shares
outstanding. The weighted average number of shares outstanding for the
three months ended March 31, 2009 and March 31, 2008 was 24,054,878.
As the Company had a loss for each of the periods presented, basic and
diluted loss per share are the same because the exercise of all stock
options would have an anti-dilutive effect.
For further information
Craig Armitage, Investor Relations, The Equicom Group, (416) 815-0700 ext 278, (416) 815-0080 fax, carmitage@equicomgroup.com
Larry Andrews, President and CEO, Cipher Pharmaceuticals, (905) 602-5840 ext 324, (905) 602-0628 fax, landrews@cipherpharma.com
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