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Cloud Call Center Community Featured Article

TMCNet: Gilead has Strong 4Q, but U.S. HIV Drug Sales Down

[January 28, 2009]

Gilead has Strong 4Q, but U.S. HIV Drug Sales Down

(BioWorld Today Via Acquire Media NewsEdge) Shares of Gilead Sciences Inc. gained $2.31 Wednesday after the Foster City, Calif.-based biotech beat Wall Street estimates for global sales of its HIV drugs in the fourth quarter of 2008.

However, U.S. sales for the quarter were not as robust as anticipated, leaving analysts puzzled.

Gilead blamed the U.S. weakness on a change of inventory in the channel, most prominently at retail pharmacies.

Gilead's product sales increased 35 percent to $1.39 billion for the fourth quarter of 2008, "marking our fifth consecutive quarter of surpassing $1 billion in total product sales and five consecutive years of quarterly product sales growth," said Chief Financial Officer Robin Washington.


The company's sales for the year rose to $5.08 billion, a 36 percent increase from 2007, she told investors and analysts late Tuesday during a conference call. Sales of Gilead's antiviral products, which includes Atripla (efavirenz-emtricitabine-tenofovir disoproxil fumarate) and Truvada (emtricitabine-tenofovir disoproxil fumarate), grew to $1.27 billion for the fourth quarter, compared with $941.1 million for the same period in 2007, Washington said.

The company's antiviral product sales for 2008 increased to $4.67 billion, a 36 percent increase from a year earlier, which Washington said was driven by volume growth of Atripla and Truvada and a favorable foreign currency exchange impact. Sales of Truvada increased to $562.1 million for the fourth quarter of 2008, up 25 percent from $448.8 million in the same quarter in 2007, she said, noting the Truvada sales contributed 44 percent to the firm's total sales figures for the quarter.

Truvada sales for the year increased 33 percent to $2.11 billion from $1.59 billion in 2007, she added.

Sales of Atripla, a three-in-one combination drug containing Gilead's Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate) and Bristol-Myer Squibb Co.'s Sustiva (efavirenz), increased 79 percent to $465.5 million for the fourth quarter of 2008 from $259.7 million for the same quarter in 2007, Washington said.

The Atripla sales contributed to 37 percent of the firm's antiviral product sales for the quarter, she added.

Atripla 2008 full-year sales increased 74 percent to $1.57 billion from $903.4 million in 2007, Washington said.

The increase in Atripla sales for the quarter and the year was driven primarily by the continued uptake in the U.S. and launches of the product in most European countries, the company reported.

"The growth of Truvada alongside Atripla is particularly gratifying and demonstrates the complementary roles of both drugs," said Kevin Young, executive vice president of commercial operations. However, he noted that while U.S. sales of Atripla were up 2 percent, those for Truvada were down 3 percent. "While demand was strong, both at the retail and non-retail level for both products, this demand was not fully reflected in our revenues for the fourth quarter," Young said. "We believe this is because during the quarter, inventories were drawn down within the distribution channel."

Nonetheless, Young said, Truvada "maintained its position as the backbone of choice for antiviral therapy in the U.S, with 188,000 patients on therapy or approximately 34 percent of all treated patients." In addition, he said, Atripla remained the most prescribed regimen in HIV, with 31 percent of patients. "This is the first time that any regimen has equaled or exceeded 30 percent share of treated patients," Young said. "Atripla together with Truvada continue to account for greater than four out of five treatment-naive patients," he added.

CEO John Martin said that "remarkably," more than 1 million HIV-infected patients around the world currently are receiving tenofovir in either Viread, Truvada or Atripla.

Sales of Viread, which is approved to treat HIV infection and chronic hepatitis B, were $162 million for the fourth quarter of 2008, representing a 9 percent increase, Washington said. The company's other hepatitis B drug, Hepsera (adefovir dipivoxil), generated sales of $76 million in the fourth quarter, which Washington noted was a 1 percent decrease from a year earlier.

Sales of AmBisome (amphotericin B), an antifungal marketed in the U.S. by Gilead's partner Deerfield, Ill.-based Astellas Pharma US Inc., were $76 million for the fourth quarter of 2008, a 12 percent increase from $67.8 million for the same period in 2007.

Sales of Letairis (ambrisentan), a drug used to treat pulmonary arterial hypertension, were $36.2 million, a twofold increase from $14.8 million a year earlier, Washington said.

Royalties, contract and other revenues from collaborations with corporate partners were $40.4 million, a decrease of 41 percent from $68.8 million in the fourth quarter of 2007, she said, noting that the decrease was driven primarily by lower royalties from its worldwide marketing partner Roche AG for the influenza drug Tamiflu (oseltamivir phosphate), which dropped to $16 million for the quarter compared with $46.1 million a year earlier.

Martin said the company continues to keep the "hurdle bar" high for Gilead's R&D programs, "only bringing forward molecules that have the potential to become best in class compounds in areas of significant unmet medical need."

The company filed an appeal to the FDA's September 2008 complete response letter for its new drug application for an inhaled version of aztreonam lysine as a treatment for cystic fibrosis-related pseudomonal infections, Martin noted. (See BioWorld Today, Sept. 18, 2008.)

The FDA wants an additional clinical study before it considers approving the product. However, regulators did not raise any significant safety concerns about the drug.

Martin said the company held a face-to-face meeting with the agency in late December and is awaiting a response.

As of Dec. 31, 2008, Gilead had cash, cash equivalents and marketable securities of $3.24 billion compared with $2.72 billion a year earlier, Washington said. For the year, Gilead generated $2.20 billion of operating cash flows including $646.1 million in the fourth quarter, she added.

Total 2008 revenues were $5.3 billion, up 26 percent over 2007. The company reported operating expenses of $1.5 billion, which represents an increase of 18 percent over 2007, Washington said.

Cowen & Co. analyst Phil Nadeau said he expected Gilead to "consistently beat and raise through the year." "Gilead's fundamentals remain among the best in large-cap biotech, and we expect the shares will outperform the market by 15-20 percent over the next 12 months," Nadeau said in a research note.

Shares of Gilead (NASDAQ:GILD) closed at $50.54 Wednesday. n

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Copyright ? 2009 Thomson BioWorld, All Rights Reserved.

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