NIH to Renew PGx Research Program
A total of up to $30 million will go to 12 or 14 investigators in 2010 to fund new and renewal studies in the Pharmacogenomics Research Network program, the National Institutes of Health said last week.
The PGRN is a consortium of interdisciplinary groups that study how genetics affect drug responses in both positive and adverse ways. These projects aim to use genomic studies to identify and validate genes involved in biological pathways, to identify variation in genes and biological pathways, to understand the consequences of genetic variation on certain drugs being studied, and to learn more about the clinical implications of using genotyping to predict drug responses.
Scientists applying for the funding may request direct costs of around $1 million to $1.5 million per year for a total of up to five years.
Although past PGRN groups have focused on areas including cardiovascular diseases, cancers, asthma, depression and addiction, researchers applying for funding may propose studying other illnesses.
The PGRN includes participation from the National Institute of General Medical Sciences; National Heart, Lung, and Blood Institute; National Cancer Institute; National Institute on Drug Abuse; National Institute on Mental Health; and National Institute of Child Health and Human Development.
Genomic Health's Q4, Full-Year Revenues Soar
Genomic Health this week reported double-digit growth in fourth-quarter and full-year 2008 revenues, accompanied by a slimmer net loss.
The company posted a 61 percent increase in revenues for the quarter ended Dec. 31, 2008, to $30.9 million from $19.3 million in the fourth quarter of 2007. Product revenue from the company's Oncotype DX breast cancer assay contributed $30.9 million to fourth-quarter revenues, an increase of 60 percent over $19.3 million in product revenue in the fourth quarter of 2007.
Kim Popovits, president and CEO of Genomic Health, said in a statement that the strong results were "fueled by the expanded clinical utility of the Oncotype DX breast cancer assay, its inclusion in clinical practice guidelines, and additional reimbursement coverage providing access to Oncotype DX for more than 90 percent of US insured lives."
Genomic Health narrowed its fourth-quarter net loss by 61 percent to $2.3 million, or $.08 per share, from $6 million, or $.21 per share, in the fourth quarter of 2007.
The company's total operating expenses rose 29 percent to $33.9 million from $26.1 million in the year-ago period. Fourth-quarter 2008 operating expenses included non-cash charges of $3.8 million, including $2.4 million of stock-based compensation expense, compared with $1.9 million in the comparable period of 2007, and $1.4 million of depreciation and amortization expenses, compared with $1.0 million in the year-ago period.
Fourth-quarter R&D spending increased 32 percent to $8 million from $6 million; selling and marketing expenses rose 15 percent to $11.6 million from $10.1 million; and general and administrative costs grew 37 percent to $7 million from $5.1 million.
For full-year 2008, Genomic Health's revenues increased 73 percent to $110.6 million from $64 million in 2007. Product revenue was $108.7 million in 2008, compared to $62.7 million in 2007.
The company's full-year net loss decreased 41 percent to $16.1 million, or $.57 per share, from $27.3 million, or $1.02 per share, in 2007.
[ pagebreak ]
R&D spending rose 30 percent to $28.6 million in 2008 from $22.1 million in 2007; full-year selling and marketing spending increased 28 percent to $46.7 million from $36.5 million; and general and administrative expenses rose 43 percent to $25.6 million in 2008 from $17.8 million in 2007.
Genomic Health had $11.2 million in cash and cash equivalents as of Dec. 31. Including short-term investments, the company's cash position was $56.7 million as of that date.
"In 2009, we intend to continue to make the necessary investments to penetrate the existing breast cancer market, broaden reimbursement to cover node-positive patients, drive international access of Oncotype DX and advance our pipeline, while continuing to move the organization toward profitability," said Brad Cole, chief operating and financial officer of Genomic Health, in a statement.
He added that the company expects the "majority" of its annual net loss to be realized in the first half of the year "as we continue to invest in our product pipeline, US sales force expansion and worldwide commercial infrastructure."
The company said that it expects to deliver between 50,000 and 53,000 test results in 2009, and that it expects full-year 2009 revenues to be in the range of $148 million to $160 million — an increase of 34 percent to 45 percent over 2008 revenues.
Genomic Health projects a 2009 net loss of $7 million to $14 million, an improvement of 13 percent to 57 percent over 2008.
Nasdaq Bumps DeCode from Global Market
DeCode Genetics' stock has been moved from the Nasdaq Global Market to the Nasdaq Capital Market after failing to maintain a minimum market value for listed shares, the company said this week.
Nasdaq decided to move DeCode to the Capital Market, which is one of three Nasdaq tiers, after a review hearing on Dec. 18, 2008, regarding its non-compliance with the market's rules.
The move to the Capital Market took effect this morning and the company will continue to be listed there, under the same market symbol (DCGN), until a review process is completed by April 29.
The company's stock was trading at $.22 per share this morning, and its current market capitalization is around $13.6 million.
Myriad's Q2 Revenues Jump 49 Percent
Myriad Genetics this week reported a 49 percent increase in second-quarter revenues year over year and a swing to a profit from a loss in the comparable period a year ago.
The Salt Lake City-based molecular diagnostics firm brought in revenues of $84.4 million for the three-month period ended Dec. 31, compared to revenues of $56.7 million for the second quarter of 2008. Myriad reported molecular diagnostics sales of $84 million for the quarter compared to $53.1 million for Q2 2008, an increase of 58 percent. Its service revenues declined to $424,000 from $3.6 million year over year.
In a statement, the firm attributed the sharp uptick in molecular diagnostics revenue to its sales and marketing efforts, which included expanding its women's health sales force to 100 sales representatives. It also believes an ongoing direct-to-consumer campaign has resulted in "improved physician acceptance and adoption of its molecular diagnostic products."
Myriad posted a profit of $21.2 million, or $.43 per share, for Q2 2009, compared to a net loss of $5.1 million, or $.11 per share, the year before. The profit handily beat analysts' average estimate of $.32 per share for the quarter.
[ pagebreak ]
The firm's R&D costs dropped 27 percent to $20 million from $27.3 million. Myriad said that the decrease was due to the discontinuation of its Alzheimer's disease program in June 2008. Its SG&A spending rose 17 percent to $35.6 million from $30.5 million.
Myriad President and CEO Peter Meldrum noted that despite the current economic climate, patient sample flow for the firm's tests "continued to be very strong."
Myriad finished the quarter with $496.9 million in cash, cash equivalents, and marketable securities.
Exact Sciences Regains Nasdaq Compliance
Exact Sciences said last week that it had regained compliance with listing requirements for the Nasdaq Capital Market.
Exact's stock was moved from the Nasdaq Global Market to the Nasdaq Capital Market in late November 2008, because its shares failed to meet certain listing requirements. That move followed a letter sent to the firm from Nasdaq on July 10, informing Exact that the value of its listed securities was below the minimum $50 million required for continued listing on the market.
Last week, the firm announced that it had sold to Genzyme certain intellectual property assets related to the fields of prenatal and reproductive health in a deal that is expected to provide the firm with a cash infusion of $24.5 million.
In addition, the Marlborough, Mass.-based firm sold to Genzyme 3 million shares of its common stock for $2 per share.
The pact with Genzyme ended Sequenom's bid to acquire Exact for $41 million.
Response Genetics, Roche Ink Cancer Test Pact
Response Genetics has signed a deal with Roche Diagnostics to support the development of a cancer assay.
The Los Angeles-based firm said this week that it had licensed to Roche non-exclusive rights to use its PCR analysis technology to assess human epidermal growth factor type 2 gene expression. A test that can accurately measure HER2 expression could assist physicians with treatment decisions for patients with certain cancers in tissues such as breast.
"This agreement strengthens our long relationship with Roche and fulfills a promise we made during our initial public offering to license our intellectual property while protecting our intellectual capital freedom," Kathleen Danenberg, Response Genetics' president and CEO, said in a statement.
Financial and other terms of the license were not disclosed.