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Favrille Reports First Quarter 2007 Financial Results

Companies mentioned in this article: Ligand Pharmaceuticals - Favrille

Favrille, Inc. (NASDAQ:FVRL) , a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer, today reported its financial results for the first quarter ended March 31, 2007. Net loss for the quarter was $10.5 million, or $0.34 per share, compared to $10.9 million, or $0.49 per share for the same period in 2006.

"We are approaching the end of the pivotal Phase 3 clinical trial for our lead product candidate, FavId, for the treatment of B-cell non-Hodgkin's lymphoma (NHL)," said John P. Longenecker, Ph.D., President and Chief Executive Officer of Favrille. "We completed enrollment in this trial in January 2006 and now eagerly await the analysis of our primary endpoint, time to disease progression (TTP). The trigger for this analysis is based upon the number of patients whose disease progresses and is currently projected to occur around the end of this year. We will closely monitor the rate of progression in the coming months and update this projection as necessary. We are currently in the process of validating our commercial-scale manufacturing facility and have begun preparations for the filing of our Biologics License Application."

First Quarter 2007 Financial Review

Research and development expense was approximately $8.0 million for the first quarter of 2007, compared to approximately $8.4 million for the same period in 2006. The decrease is primarily due to a decrease in Phase 3 clinical trial expense related to the completion of patient enrollment into the Company's pivotal Phase 3 clinical trial in January 2006, offset by an increase in utilities, maintenance, depreciation and lease expenses and laboratory supplies associated with the commercial-scale facility expansion.

Marketing, general and administrative expense was approximately $2.9 million for the first quarter of 2007, compared to approximately $2.7 million during the same period in 2006. The increase primarily reflects an increase in compensation costs associated with additional administrative personnel and stock-based compensation, offset by a decrease in outside services related to strategic marketing programs and consulting services related to a software implementation project expensed in 2006.

As of March 31, 2007, cash, cash equivalents and short term investments were approximately $41.9 million, compared to $42.4 million at December 31, 2006. The decrease resulted primarily from net cash used to fund ongoing operations partially offset by the $10 million in gross proceeds from the registered direct offering of common stock in February 2007.

"We expect total operating expenses for the full year 2007 to be in the range of $48 million to $52 million, including an estimated $4 million to $5 million in stock-based compensation," said Tamara A. Seymour, Chief Financial Officer of Favrille. "We believe our cash on hand along with access to the committed equity financing facility we established with Kingsbridge Capital Limited in December 2006 should be sufficient to fund operations for at least 12 months."

Recent Highlights

* Appointed Chief Medical Officer. Earlier this week Favrille appointed Richard Ghalie, M.D., as Chief Medical Officer to direct the Company's medical research activities. A licensed hematologist and oncologist, Dr. Ghalie comes to Favrille with nearly 15 years of experience in the biopharmaceutical industry and a strong background in clinical development, FDA interactions, product approvals and launch, as well as post-marketing studies and support. He served most recently as Vice President of Medical Affairs and Professional Services at Ligand Pharmaceuticals Inc.

* Reported Positive Data at AACR. Favrille announced results from a new study showing enhanced activity from insect-cell derived idiotype proteins, a key component in the Company's Id/KLH immunotherapy product candidate FavId for B-cell NHL, compared to idiotype proteins produced using mammalian cells. The data were reported at the American Association for Cancer Research (AACR) Annual Meeting last month in Los Angeles.

* Entered Agreements with Expression Systems. Favrille recently entered into five-year supply and license agreements with Expression Systems LLC for insect cell growth media that Favrille uses in the production of FavId. Under the terms of the agreements, Favrille has the right to purchase raw material components from Expression Systems and manufacture the cell growth media in-house. Each agreement is also renewable for one three-year period at Favrille's option, ensuring a long-term supply in preparation for commercialization of FavId.

* Entered Agreement with Berlex. Favrille also entered into an agreement with Berlex, Inc., a U.S. affiliate of Bayer Schering Pharma AG, Germany, in February. This agreement helps pave the way for commercialization, including reimbursement, of FavId in combination with Berlex's Leukine (sargramostim, GM-CSF), a growth factor designed to enhance a patient's immune response.

* Raised $10 Million in Registered Direct Offering. Favrille completed a $10 million registered direct common stock offering in February. Selected investors, including leading life sciences institutional investor Federated Kaufmann Fund, purchased 3.3 million shares of the Company's common stock at a price of $3.00 per share pursuant to an effective shelf registration statement.

Conference Call and Webcast Information

Favrille management will host a conference call today to discuss the first quarter 2007 financial results at 4:30 p.m. Eastern Time. A live audio webcast of management's presentation will be available at www.favrille.com. Alternatively, callers may participate in the conference call by dialing (800) 659-2037 or (617) 614-2713, passcode 83529659. A telephone replay of the call will also be available for 48 hours. The telephone replay can be accessed by dialing (888) 286-8010 or (617) 801-6888, passcode 58275228.

About Favrille, Inc.

Favrille, Inc. is a biopharmaceutical company focused on the research, development and commercialization of targeted immunotherapies for the treatment of cancer and other diseases of the immune system. The Company's lead product candidate, FavId, is based upon unique genetic information extracted from a patient's tumor. FavId is currently under investigation in a pivotal Phase 3 clinical trial for patients with follicular B-cell NHL and Phase 2 clinical trials in other B-cell NHL indications. The Company is developing additional applications based on its immunotherapy expertise and proprietary cost-effective manufacturing technology, including a second product candidate, FAV-201, for the treatment of T-cell lymphoma.