conference date: August 7, 2007 @ 2:00 PM Pacific Time
for quarter ending: June 30, 2007 (1st quarter 2007)
Overview: Revenues from Nexavar partnership with Bayer continue to increase rapidly, but company still has a net loss.
Cash and equivalents ended at $454.4 million.
R&D costs to expand to 2006 level. SG&A increasing to $49.2 million annually..
Bayer recorded Nexavar revenues of $81.3 million, up 150% over $32.2 million year-earlier (and up 34% sequentially) as domestic sales increased and international sales expanded. As a result the net amount due from Bayer for the quarter was $7.5 million, up from $3.0 million in Q1, which is recorded as a contra-expense.
Expects to launch Nexavar for liver cancer next year (44% increase in survival in trial reported, with average 3 month survival extension and no safety issues). Pursuing comprehensive strategy across many tumor types. Enrollment in new studies (lung cancer, advanced melanoma) is progressing.
Operating expenses included $6.4 million for R&D and SG&A of $15.7 million.
Net loss was $10.8 million or $0.22 per share. Net loss included $3.6 million in stock-based employee compensation expense.
$49.3 million shared Nexavar marketing expenses. Expect shared development and SG&A expected to increase going forward as they prepare for liver cancer launch.
$174 million of cash is from a public offering that took place in June.
Liver cancer launch will be using much of the existing renal cancer infrastructure, so it should increase revenues more than it increases costs.
Patient group issues for liver cancer? Trial success was in a subset, but given lack of therapies for liver cancer, we believe a broader group will have an opportunity to take Nexavar during the course of their disease.
Need to show additional efficacy for Japan approval? No. Trials in Asia have other purposes. Evaluating study in combination with tace (sp?) to expand use for liver cancer.
Currency issues? Not a significant effect because we have expenses as well as revenues in foreign currencies.
Interim analysis results? We do interim analysis for safety and efficacy in every trial, but we do not make announcements until we have final results.
Breast cancer plans? We have plans for several more clinical trials, all randomized, placebo controlled trials in combination with other therapies.
Renal cell v. hepacellular split? No data yet, just a few weeks experience. Won't see major market penetration until approval.
Shared development expenses? $160 million annually.
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