Staff Writer

Gilead Sciences Inc. beat analyst expectations for third-quarter revenues and earnings per share, rebounding from its second-quarter EPS miss and posting record product sales thanks to the continued strong growth of its HIV franchise.

Shares in the Foster City, Calif.-based company (NASDAQ:GILD) popped up more than 10 percent in midday trading on Friday before settling at $43.03, a gain of $1.64 for the day.

Gilead reported third-quarter earnings of $504 million, or 52 cents per share, on a GAAP basis, and $534.1 million, or 55 cents per share, on a non-GAAP basis - beating analyst EPS estimates of 49 cents per share.

During an investor conference call, Gilead Chairman and CEO John Martin attributed the strong performance both to record product sales and "disciplined management of our expenses."

Third-quarter total revenues reached a record $1.37 billion, up 30 percent over the third quarter of 2007 and beating analyst estimates of $1.32 billion.

Product revenues also hit a record high, reaching $1.34 billion for the quarter, a 39 percent increase over the same period last year.

Bringing in the bulk of the money were HIV drugs Truvada (emtricitabine and tenofovir disoproxil fumarate) and Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).

Truvada sales grew 34 percent over the third quarter of 2007 to $549.1 million, while Atripla sales grew a whopping 77 percent to $427.6 million.

Meanwhile HIV drug Viread (tenofovir disoproxil fumarate) brought in $156 million, hepatitis B drug Hepsera (adefovir dipivoxil) brought in $91.2 million, antifungal drug AmBisome (amphotericin B) brought in $72.9 million and pulmonary arterial hypertension drug Letairis (ambrisentan) brought in $31.7 million.

Royalty revenue from partner F. Hoffmann-La Roche Ltd. related to sales of Tamiflu (oseltamivir phosphate) decreased to $8.6 million for the quarter from $77.4 million in the third quarter of 2007, primarily because of changes in worldwide pandemic flu planning.

On the expense side of the equation, Martin cleared up lingering questions from last quarter about Gilead's plans to increase research and development investment. (See BioWorld Today, July 21, 2008.)

He emphasized the company's intention to "continue to keep a vigilant focus on managing our expenses," and he said the current R&D spend rate of 12.5 percent allows the company to "manage the business very efficiently."

Also key to managing R&D spending is maintaining a high bar for advancing pipeline products, Martin said.

One pipeline product to advance during the quarter was HIV drug elvitegravir (GS 9137), which started a Phase III trial in July. Also moving through Phase III is resistant hypertension drug darusentan.

On the regulatory front, the third quarter brought one approval and one setback for Gilead. HIV drug Viread gained an expected approval for hepatitis B, while aztreonam lysine got a complete response letter seeking another trial in response to its bid for approval to treat cystic fibrosis-related pseudomonal infections. (See BioWorld Today, Aug. 13, 2008, and Sept. 18, 2008.)

Martin said Gilead is "continuing our dialogue with the agency" regarding aztreonam lysine.

Gilead ended the quarter with $3.26 billion in cash, equivalents and marketable securities after generating operating cash flows of $1.56 billion in the first nine months of the year.

The company has put some of its money to work repurchasing $1.2 billion worth of its shares during the year, and another $750 million worth of shares will be repurchased on an accelerated basis, the company said.

Despite the strong quarter, Gilead maintained its projected revenue guidance of $4.9 billion to $5 billion for the year, citing uncertainties about foreign exchange rates.

In other earnings news:

• Cubist Pharmaceuticals Inc., of Lexington, Mass., reported that third-quarter net sales of the antibiotic Cubicin (daptomycin for injection) increased 45 percent from the prior year, to $110.6 million, helping it easily beat consensus earning estimates. With Cubicin leading the way, Cubist saw revenues increase 41 percent and net income 39 percent over the third quarter of 2007. Net income for the third quarter on a GAAP basis was $27.9 million, or 49 cents and 44 cents per basic and diluted share, respectively, compared to $20 million, or 36 cents and 32 cents per basic and diluted share, respectively, for the third quarter of 2007. Non-GAAP net income, excluding stock-based compensation expenses, was $30.8 million. The company had $373.1 million in cash, cash equivalents and investments as of Sept. 30. Cubist's stock (NASDAQ:CBST) gained $1.25 Friday, to close at $21.64.