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Dynavax Technologies Corporation (DVAX)
Q4 2007 Earnings Call
February 19, 2008, 4:15 pm ET
Shari Annes - Investor Relations Consultant
Dino Dina - President and Chief Executive Officer
Deborah Smeltzer - Vice President, Operations and Chief Financial Officer
Bret Holley - Oppenheimer & Company
Katherine Xu - Credit Suisse
Alan Leong - Biotech Stock Research
Brian McCarthy - Merriman Curhan & Ford
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Shari Annes – Investor Relations Consultant
Thank you. Good afternoon and thank you for joining this call. As you know, the subject of the call is Dynavax's fourth quarter and year-end 2007 financial results and guidance for 2008. Participating in today's call are Dino Dina, President and Chief Executive Officer and Deborah Smeltzer, Vice President, Operations and Chief Financial Officer.
Following my introduction, Dino will provide a summary of the year's achievements. Deborah will review financial results for the quarter and the full year, and after opening the call for your questions, Dino will provide a closing statement.
Please be advised that this conference call will include forward-looking statements that are subject to a number of risks and uncertainties, including statements about our projected cash position and operating results. Actual results may differ materially from those set forth in this call due to the risks and uncertainties inherent in our business, including: achievement of our Merck agreement collaboration objectives and milestones and regulatory approvals under our third party funding arrangements. Continuation of our third party collaboration and funding arrangements; difficulties or delays in research and development; initiation and completion of clinical trials; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the scope and validity of patent protection and the possibility of claims against us based on the patent rights of others; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
In addition, with respect to the statements by Deborah Smeltzer regarding the financial outlook, I further remind you that they are forward-looking and are based on current expectations. Actual results may differ materially. These statements do not include the potential impact of any equity offerings, new business collaborations, or other transactions that may be closed or entered into after today. And now I'll turn the call over to Dino Dina.
Dino Dina - President and Chief Executive Officer
Thank you. 2007 was a year of significant achievements for Dynavax. Highlighting the year was of course the cooperation we announced with Merck to conceive development and commercialize HELPISAV or enhance two-dose hepatitis B vaccine. This agreement commonly set the commercialization facts for HELPISAV and improved the likelihood of its becoming an important addition to the market for global vaccine.
With an upfront fee of $31.45 million dollars full funding for product development and significant milestones and royalties we gained considerable financial recourses there being leveraged across our other product portfolios. As part of the agreement, we're moving forward to expand our production facility in Düsseldorf to meet the supply requirements of Merck once the product is launched.
Our Phase II study of HELPISAV in Canada in Germany has been completed. As you know, the trail compares the immunogenicity of two-doses of HELPISAV with the immunogenicity for three doses of Anthrax B. With the trail complete, we have stayed on track, which is the next milestone in the HELPISAV program. Importantly in mid 2008 we'll report data from this pivotal Phase III study.
Next I'd like to discuss the landmark, our ragweed allergy immunotherapy. Based on an in-depth and pre-specified analysis of the DARTT trail, we presented an important new set of findings that couldn’t play our meeting last February. We showed that in the Midwest we had successfully recruited individuals with measurable Ragweed Allergy disease and in that geographic area we had shown statistically significant clinical effect for TOLAMBA, much as we had seen in previously successful studies. And of course differently from what the total studies showed.
Later in the year in a presentation made at the College of Allergy Asthma and Immunology, we provided the detailed analysis of the data from the DARTT trail that significantly expanded our understanding of the correlation between skin test parameters and the magnitude of ragweed allergic corneitis symptoms in placebo-treated patients.
Specifically this analysis provided valuable insights that we used to guide the design of future clinical trails. With this extensive understanding of the DARTT trail, we announced in July the $30 million commitment by Deerfield Partners to restart the TOLAMBA development. And the funding was also earmarked to advance our Cat and peanut allergy programs to the clinic. Importantly while Deerfield is providing at risk capital for the TOLAMBA trails we retained all products lines moving forward.
In October, we started environmental exposure chamber study designed to confirm and extend the observations obtained in the DARTT study. We expect that the chamber study data will help us design potential future field studies of TOLAMBA, a study that will increase the likelihood of enrolling patients with measurable disease and therefore, one that will presumably show efficacy. That study would begin in late 2008 or early 2009.