MAP Pharmaceuticals announces net loss of $13.4M for fourth-quarter 2009

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced financial results for the fourth quarter and year ended December 31, 2009.

The net loss for the fourth quarter ended December 31, 2009 was $13.4 million compared to $21.8 million during the same period in 2008. The net loss for the year ended December 31, 2009 was $9.0 million compared to $72.9 million for the year ended December 31, 2008.

MAP Pharmaceuticals had $65.8 million in cash and cash equivalents as of December 31, 2009. Additionally, in January 2010, the company received net proceeds of approximately $19.7 million pursuant to an equity line of credit common stock purchase agreement with Azimuth Opportunity, Ltd.

"With our strong Phase 3 clinical results and recent notification from the FDA that a second pivotal efficacy trial will not be required, we have made significant progress towards our goal of bringing LEVADEX to many of the approximately 30 million migraine sufferers in the U.S., including many who are not helped by currently available migraine therapies," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals.  "We remain focused on completing patient treatment in the remaining safety, pharmacokinetics and pharmacodynamics trials this year to support our planned NDA filing."

2009 and 2010 Year-to-Date Accomplishments and Upcoming Milestones

LEVADEX™ (formerly known as MAP0004)

• Met all four primary endpoints in the efficacy portion of FREEDOM-301, the first Phase 3 clinical trial of LEVADEX for the potential acute treatment of migraine.  Additional endpoints showed that LEVADEX provided rapid and sustained pain relief for up to 48 hours.
• Completed a planned six month interim safety review of the open-label, long-term safety extension of FREEDOM-301, with no drug-related serious adverse events reported.  The trial is continuing as planned.
• Received notification from the U.S. Food and Drug Administration that a second pivotal efficacy study is not required for the LEVADEX new drug application (NDA) submission.   The remaining clinical trials needed for NDA submission include the ongoing open-label, long-term safety extension trial, a pharmacokinetics (PK) trial and a pharmacodynamics (PD) trial. The company anticipates that patients in these trials will complete treatment in 2010.
• Initiated the PK trial in smokers and non-smokers.
• Anticipate initiating the PD trial in the first half of 2010.
• Presented additional analysis of FREEDOM-301 at the 14th Congress of the International Headache Society showing the potential of LEVADEX to effectively treat acute migraine as well as a broad spectrum of migraine, including subpopulations that are resistant to current treatments such as triptans.
• Published results from an in vitro study of LEVADEX exploring the potential mechanisms by which the PK and PD of the compound may produce fewer adverse events than those seen in intravenous dihydroergotamine in Headache: The Journal of Head and Face Pain.

Corporate

• Raised gross proceeds of $34 million in a common stock offering.
• Secured a committed equity financing facility under which the company may sell up to $60 million of its common stock to Azimuth Opportunity Ltd, and raised gross proceeds of $20 million through this facility.
• Received $54 million pursuant to the license agreement with former partner AstraZeneca.
• Appointed Alan Petro as Vice President, Manufacturing and Technical Operations—a key hire as the Company prepares for the potential commercialization of LEVADEX.  Mr. Petro brings more than 25 years of product/process development and manufacturing operations experience.

Fourth Quarter and 2009 Year End Financial Results

Revenues for the fourth quarter and year ended December 31, 2009 were $2.8 million and $54.2 million, respectively, compared to $0 for the same periods in 2008. Revenue for fiscal 2009 was due to a $40.0 million upfront payment and reimbursements of development expenses for Unit Dose Budesonide (UDB), the company's nebulized pediatric asthma product candidate, pursuant to the license agreement with AstraZeneca AB.  This license agreement was terminated on July 8, 2009, and all development expense reimbursements have been received as of December 31, 2009.

Research and development (R&D) expenses for the fourth quarter ended December 31, 2009 were $12.4 million, compared to $17.7 million for the same period in 2008.  The decrease in R&D expenses for the fourth quarter ended December 31, 2009 as compared to the same period in 2008 was driven primarily by a decrease in clinical and other related expenses to support the UDB Phase 3 clinical program as a result of suspending the development of UDB in the third quarter of 2009, partially offset by an increase in other project related expenses and an increase in clinical and other related expenses to support the LEVADEX Phase 3 clinical program.  

R&D expenses for the year ended December 31, 2009 were $48.0 million, compared to $59.3 million for the year ended December 31, 2008. The decrease in R&D expenses for the year ended December 31, 2009 as compared to the year ended December 31, 2008 was driven primarily by a decrease in clinical and other related expenses to support the UDB Phase 3 clinical program as a result of suspending the UDB program, partially offset by an increase in clinical and other related expenses to support the LEVADEX Phase 3 clinical program and an increase in personnel related expenses.

Sales, general and administrative (SG&A) expenses for the fourth quarter ended December 31, 2009 were $3.3 million compared to $3.7 million for the same period in 2008. The decrease in SG&A expenses for the fourth quarter ended December 31, 2009 as compared to the same period in 2008 was related primarily to a decrease in professional services, partially offset by an increase in personnel related expenses.

SG&A expenses for the year ended December 31, 2009 were $13.1 million compared to $13.4 million for the year ended December 31, 2008. The decrease in SG&A expenses for the year ended December 31, 2009 as compared to the year ended December 31, 2008 was related primarily to a decrease in professional services, partially offset by an increase in stock-based compensation and an increase in personnel related expenses.

MAP Pharmaceuticals had cash, cash equivalents and short-term investments of $65.8 million as of December 31, 2009, compared to $44.7 million as of December 31, 2008.  For the fourth quarter and year ended December 31, 2009, non-cash share-based compensation and depreciation was approximately $1.5 million and $6.4 million, respectively.  Additionally, in January 2010, the company received net proceeds of approximately $19.7 million from drawing down on an equity line of credit pursuant to the common stock purchase agreement with Azimuth signed on November 11, 2009.

2010 Financial Outlook

MAP Pharmaceuticals' financial outlook is based on current expectations.  The following statements are forward looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements."

In 2010 the company currently anticipates operating expenses, excluding non-cash share-based compensation and depreciation to be approximately $42 to $46 million.  In addition, the company currently anticipates capital expenditures to be approximately $3 to $4 million.  As previously disclosed, the company has loan payments of approximately $8 million in 2010 related to a working capital loan.  

SOURCE MAP Pharmaceuticals, Inc.