Analyst Conference Summary
|Revenues by product (millions):|
y/y increase 23%
Antiviral inventory, including the supply chain, remained flat sequentially. We have not seen a significant increase in patients seeking financial assistance. US HIV revenues performed strongly lead by Atripla and Truvada. 7% increase in anti-viral therapy patients in U.S. 4 out of 5 new patients used Atripla, Truvada, or both. Europe also seeing revenue growth.
Letairis for pulmonary arterial hypertension (PAH) subscribing base has grown significantly over the last year. "We are very committed to the growth of Letairis."
Cost of goods sold was $329 million. Research and development expense $189 million. Selling, general and administrative expense was $204 million. Leaving income from operations of $808 million. Interest and other expense was negative $12 million [partly due to APB 14-1 and SFAS 160 adoption]. There was also a loss of $2.5 million attributable to noncontrolling interest.
Solid progress in pipeline programs. Two Phase I studies of GS 9350 were good. Elvitegravir is in Phase III in combination with ritonavir, to be compared to twice-daily raltegravir for HIV. Also in a Elvitegravir with Truvada Phase II trial. For HCV completed enrollment in Phase IIb study of 9190. However, the FDA decided Gilead needs additional studies before aztreonam for inhalation can be approved. Cicletanine hydrochloride Phase II trial has begun enrolling pulmonary arterial hypertension patients.
Was your French reimbursement included in your prior guidance? Yes. The French market is the number 2 market outside the U.S. We think Atripla will be very appealing because of its cost efficiency. Product should be available in June to patients.
More on reimbursements, including Medicaid? About 35% of U.S. patients go through federal programs. ADAP program purchases have been smoother this year than in the past.
Pfizer-Glazo HIV alliance threat? If they develop more products, that is a good thing for patients. However, they don't appear to have anything competitive with Gilead in their pipelines.
Your revenue guidance now looks conservative, so what causes uncertainty? We are concerned because of potential currency fluctuations and unknowns from CVT acquisition. We will include CV Therapeutics in guidance next quarter.
9350 results, what does "good" mean? ELT normalizations were positive, so we initiated a phase IIb study. Data details will be presented later this year.
CV Therapy has about 130 people in its sales force. We are doing sizing analysis. If we do a resistant hypertension launch (Darusentan) we may need additional salespeople for specialists.
Viread and Hepsera prices were increased by 7.9% on April 1.
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Copyright 2009 William P. Meyers