Friday, February 12, 2010

ZymoGenetics, Inc. Q4 2009


On the RECOTHROM front, we continue to gain market share and in January we published pooled safety and immunogenicity data across 8 different clinical studies in the Journal of the American College of Surgeons. This data further supports the safety and differentiation of RECOTHROM as a topical hemostat; we have recently been notified by FDA that they will require more time to analyze the mix of the citizen petition we filed in August which was inline with our expectations for their actions. Less visible but no less important will be the GMP manufacturing of the IL-31 monoclonal antibody and the initiation of IND enabling toxicology studies to support a first half 2011 IND Filing.

The company proceed of $13.6 million profits for the quarter which resulted from a one set of recognition at differed revenue related to restructuring of the their agreement. It was the positive quarter financially was increased RECOTHROM sale further reductions in ongoing operating expenses. A $94 million of cash inflow is from milestone payments.

All of our financial goals for the year ending with the strong cash position strengthen further by the additional $91 million rate of last month. Net sales of RECOTHROM increased $10.6 million for the quarter including 1.4 million (inaudible) to try the clinic launch in Canada. For the year sales of (inaudible) firm within our range of guidance further in asset sales to be included. At the hospital level we continue to see increasing demand in Q4, we estimated the growth that approximately 18% compared to the third quarter. Cognition and license revenue for the quarter were $51.2 million and the largest component of this total was the acceleration of $34 million related to their agreement.

Baxter International Inc. Q4 2009

In our regenerative medicine business we initiated a Phase III study evaluating Tisseel, fiber and sealant as a hemostatic agent in vascular surgery and completed a Phase III study evaluating the use of Artiss fiber and sealant in facial surgery in the United States.......
Sales in regenerative medicine which includes our bio surgery products, totaled $125 million and increased 24%. Sales excluding foreign currency grew 18% and continued to reflect robust growth of Floseal.

JnJ 2009 Earnings Call January 2010

We received FDA approval in October for the SURGIFLO Hemostatic Matrix chip, an advanced flowable hemostat for use in a broad range of surgical procedures. This is our first product launch resulting from Ethicon’s 2008 acquisition of Omrix. The regulatory knowledge gained from this combination product will be valuable as we continue to develop and commercialize other combination products in our pipeline like the Fibrin Pad, which I will address in a minute.......
As I mentioned earlier, Johnson & Johnson leads the industry in developing next-generation advanced hemostats to address the persistent clinical problems associated with bleeding in surgical settings, and we are very excited by the potential of the Fibrin Pad. With our human-plasma based biologics embedded directly into a proprietary matrix, the Fibrin Pad has the potential to uniquely and effectively address bleeding challenges that are hardly unmet by traditional hemostats. As Louise mentioned earlier, the BLI filing for the Fibrin Pad is now expected in the first half of this year.
And obviously, the best thing is to take the $7 billion we are investing and be able to generate products like Simponi or Stelara or Sedasys or the Fibrin Pad. Like, if we see other opportunities to license or to partner, partner may be an even more strategic investment than just a license. But, we will continue to take advantage of each of those in the areas where we see again the biggest opportunities for growth in the corporation.