...ich habs mal überflogen. Es steht, soweit ich erkennen kann, nichts weltbewegendes drin. Das ganze Dokument ist aber durchzogen von Unsicherheiten - man merkt schon, dass Keryx' Wohl und Wehe von einem oder nur wenigen Produkten in der Pipeline abhängt. Keryx erwartet im 2. Halbjahr 2011 die Ergebnisse der Phase III-Studie zu Perifosine bei Darmkrebs und im 2. Halbjahr 2012 die Ergebnisse der Phase III-Studie für Perifosine bei Multipler Sklerose.
Auf der Keryx-Webseite gibt's eine firmeneigene Zusammenfassung:
Keryx Biopharmaceuticals, Inc. Announces Fourth Quarter and Year-End 2010 Financial Results Keryx to Host Investor Conference Call on Wednesday, March 9, 2011 at 8:30am EST
NEW YORK, March 8, 2011 /PRNewswire via COMTEX/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and renal disease (the "Company"), today announced its results for the fourth quarter and year ended December 31, 2010.
At December 31, 2010, the Company had cash, cash equivalents, interest receivable, and investment securities of $28.5 million, as compared to $35.9 million at December 31, 2009.
The net loss for the fourth quarter ended December 31, 2010 was $5.3 million, or $0.09 per share, compared to a net loss of $4.7 million, or $0.08 per share, for the comparable quarter in 2009, representing an increase in net loss of $0.6 million. Other research and development expenses increased by $2.6 million, as compared to the fourth quarter of 2009, principally related to the KRX-0401 (perifosine) and Zerenex Phase 3 clinical programs. The fourth quarter of 2009 included a $1.5 million one-time research and development expense related to a terminated early-stage pipeline product candidate, which accounts for the net increase in other research and development expenses of $1.1 million as compared to the fourth quarter of 2009.
The net loss for the year ended December 31, 2010, was $20.3 million, or $0.34 per diluted share, compared to net income of $10.5 million, or $0.21 per diluted share, for the year ended December 31, 2009. The change in net (loss) income was primarily attributable to a $21.6 million decrease in license revenue and a $3.6 million decrease in other revenue. License revenue in the year ended December 31, 2009 was related to an amendment to the September 2007 sublicense agreement with Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. (JT/Torii) which eliminated the Company's significant ongoing obligations included in the original agreement ($18.0 million) and a $3.0 million milestone payment from JT/Torii earned in the first quarter of 2009. Other revenue in the year ended December 31, 2009 was primarily related to the settlement of a dispute for $3.5 million with the former licensor of Sulonex (sulodexide), in July 2009. The change in net (loss) income was also attributable to a $6.4 million increase in other research and development expenses primarily related to increased expenses for KRX-0401 (perifosine) and Zerenex, as compared to the comparable period last year, related to the Company's ongoing Phase 3 clinical development programs.
Ron Bentsur, the Company's Chief Executive Officer, commented, "Following another very exciting year, with both of our compounds entering Phase 3 development under SPA agreements with the FDA and the announcement of positive Phase 3 data on Zerenex, we expect to leverage the momentum in 2011 with the anticipated completion of our Phase 3 metastatic colorectal study. On the financial side, we believe we are sufficiently funded to realize the value inherent in our late stage compounds, which we believe represent tremendous commercial opportunities." |