August 4, 2011
MAP Pharmaceuticals Reports Second Quarter of 2011 Financial Results
MOUNTAIN VIEW, Calif., Aug. 4, 2011 /PRNewswire/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced financial results for the second quarter ended June 30, 2011.
The net loss for the three months ended June 30, 2011 was $8.6 million compared to $12.5 million during the same period in 2010. The net income for the first six months of 2011 was $9.0 million compared to a net loss of $26.5 million during the same period in 2010. Net income for the first six months of 2011 was impacted positively by $37.7 million in collaboration revenue recognized from a $60.0 million upfront payment received in February 2011 pursuant to a collaboration agreement with Allergan, Inc., compared to no collaboration revenue for the first six months of 2010.
"We completed a very productive second quarter of 2011 including the submission of our New Drug Application for LEVADEX to the U.S. Food and Drug Administration, which we recently announced was accepted for filing," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "This accomplishment brings us closer to our goal of providing millions of patients in an underserved migraine patient population with a potential new treatment option. We are now focusing our efforts on building infrastructure and preparing for the launch and commercialization of LEVADEX, if approved."
2011 Year-to-Date Accomplishments:
- Announced a strategic collaboration with Allergan to co-promote LEVADEXÃ® orally inhaled migraine drug, upon potential approval, to neurologists and pain specialists in the United States for the acute treatment of migraine in adults. Allergan will leverage its existing U.S. sales force dedicated to headache specialists using BOTOXÃ® for the preventative treatment of headaches in patients with Chronic Migraine, which will be complemented by a 50 person MAP Pharmaceuticals field sales force targeting neurologists and pain specialists. Allergan recently executed an option to expand the collaboration to include Canada for neurologists and pain specialists. MAP Pharmaceuticals retains all rights to commercialize LEVADEX to primary care physicians within the United States and Canada, as well as all rights to LEVADEX outside the United States and Canada.
- Announced that the New Drug Application (NDA) for LEVADEX for the potential acute treatment of migraine in adults was submitted to and accepted for filing by the U.S. Food and Drug Administration (FDA), with a goal date of March 26, 2012 under the Prescription Drug User Fee Act (PDUFA).
- Received an upfront payment of $60.0 million pursuant to the collaboration agreement with Allergan, and may receive up to $97.0 million in additional payments upon meeting certain regulatory milestones associated with the initial indication. The recent acceptance for filing of the NDA by the FDA triggers a first milestone payment of $20.0 million from Allergan.
- Published results from the Phase 3 FREEDOM-301 study of LEVADEX orally inhaled migraine drug in the peer-reviewed journal 'Headache.'
- Presented additional data on LEVADEX at various medical meetings including the 63rd Annual Meeting of the American Academy of Neurology, the 53rd Annual Scientific Meeting of the American Headache Society and the 15th Congress of the International Headache Society.
Second Quarter and Six Month Financial Results
Revenues for the three and six months ended June 30, 2011 were $3.5 million and $37.7 million, respectively, compared to $0.0 for the same periods in 2010. In February 2011, pursuant to the Allergan collaboration agreement, Allergan paid the Company an upfront payment of $60.0 million, $3.5 million and $37.7 million of which was recognized, respectively, as collaboration revenue for the three and six months ended June 30, 2011. The remaining $22.3 million is deferred revenue and will be amortized as collaboration revenue over the estimated obligation periods.
Research and development (R&D) expenses for the three and six months ended June 30, 2011 were $7.3 million and $18.8 million, respectively, compared to $8.2 million and $18.0 million, respectively, for the same periods in 2010. For the three months ended June 30, 2011 compared to the same period in 2010, the decrease in R&D expenses was due primarily to a decrease in clinical and other project expenses to support the LEVADEX Phase 3 clinical program, partially offset by an increase in personnel related expenses including stock-based compensation. For the six months ended June 30, 2011 compared to the same period in 2010, the increase in R&D expenses was due primarily to an increase in personnel related expenses including stock-based compensation, partially offset by a decrease in other expenses.
Sales, general and administrative (SG&A) expenses for the three and six months ended June 30, 2011 were $4.8 million and $9.6 million, respectively, compared to $3.9 million and $7.8 million, respectively, for the same periods in 2010. For the three and six months ended June 30, 2011 compared to the same periods in 2010, the increase in SG&A expenses was due primarily to an increase in personnel related expenses including stock-based compensation, and an increase in professional services expenses.
For the three and six months ended June 30, 2011, non-cash stock-based compensation and depreciation expense were approximately $2.0 million and $4.4 million, respectively.
About MAP Pharmaceuticals
MAP Pharmaceuticals is an emerging biopharmaceutical company focused on developing and commercializing new therapies to address undermet patient needs in neurology. The Company is developing LEVADEX, an orally inhaled investigational drug for the acute treatment of migraine. The U.S. Food and Drug Administration has accepted for filing the New Drug Application for LEVADEX for the potential acute treatment of migraine in adults. MAP Pharmaceuticals has entered into a collaboration agreement with Allergan, Inc. to co-promote LEVADEX to neurologists and pain specialists in the U.S. and Canada. The Company also applies its proprietary drug particle and inhalation technologies to generate new pipeline opportunities by enhancing the therapeutic benefits of proven drugs, while minimizing risk by capitalizing on their known safety, efficacy and commercialization history. Additional information about MAP Pharmaceuticals can be found at http://www.mappharma.com.
In addition to statements of historical facts or statements of current conditions, this press release contains forward-looking statements, including with respect to MAP Pharmaceuticals' LEVADEX product candidate. Actual results may differ materially from current expectations based on risks and uncertainties affecting the Company's business, including, without limitation, risks and uncertainties relating to the regulatory process to have the Company's LEVADEX product candidate approved for commercial use and the commercialization of LEVADEX, if approved. The reader is cautioned not to unduly rely on the forward-looking statements contained in this press release. MAP Pharmaceuticals expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Additional information on potential factors that could affect MAP Pharmaceuticals' results and other risks and uncertainties are detailed in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2011, available at http://edgar.sec.gov.
CONTACT: Christopher Y. Chai, Sr. Vice President and Chief Financial Officer of MAP Pharmaceuticals, Inc., (650) 386-3107; or media, Lisa Borland, (650) 386-3122, [email protected].
MAP PHARMACEUTICALS, INC. (a development stage enterprise) CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands) (Unaudited)
June 30, December 31, 2011 2010 ---- ---- ASSETS Cash and cash equivalents $103,461 $76,007 Accounts receivable 384 - Other current assets 516 644 Total current assets 104,361 76,651 Property and equipment, net 5,782 5,803 Other assets 27 30 Restricted investment 310 310 --- --- Total assets $110,480 $82,794 ======== ======= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $7,169 $12,440 Debt 3,715 7,581 Current portion of deferred revenue 14,400 - ------ --- Total current liabilities 25,284 20,021 Deferred revenue, less current portion 7,925 - Other liabilities 105 117 --- --- Total liabilities 33,314 20,138 Total stockholders' equity 77,166 62,656 ------ ------ Total liabilities and stockholders' equity $110,480 $82,794 ======== =======
MAP PHARMACEUTICALS, INC. (a development stage enterprise) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (Unaudited)
Three Months Ended June 30, --------------------------- 2011 2010 Collaboration revenue $3,513 $ - Operating expenses: Research and development 7,259 8,242 Sales, general and administrative 4,796 3,910 Total operating expenses 12,055 12,152 Income (loss) from operations (8,542) (12,152) Other expense, net (84) (337) Net income (loss) $(8,626) $(12,489) Net income (loss) per share Basic $(0.28) $(0.47) Diluted $(0.28) $(0.47) Weighted average common shares used in computing net income (loss) per share Basic 30,333 26,480 Diluted 30,333 26,480
Six Months Ended June 30, ------------------------- 2011 2010 Collaboration revenue $37,675 $ - Operating expenses: Research and development 18,827 18,028 Sales, general and administrative 9,639 7,791 Total operating expenses 28,466 25,819 Income (loss) from operations 9,209 (25,819) Other expense, net (231) (728) Net income (loss) $8,978 $(26,547) Net income (loss) per share Basic $0.30 $(1.01) Diluted $0.28 $(1.01) Weighted average common shares used in computing net income (loss) per share Basic 30,272 26,168 Diluted 31,595 26,168
SOURCE MAP Pharmaceuticals, Inc.