MAP PHARMACEUTICALS INC. 
By MOUNTAIN VIEW, Calif., May 4, 2012 /PRNewswire/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced financial results for the first quarter ended March 31, 2012.
The net loss for the first quarter ended March 31, 2012 was $17.8 million, compared to a net loss of $16.0 million during the same period in 2011. The net loss for the first quarter ended March 31, 2012 included a one-time expense of $2.8 million for the purchase of a data package relating to the propellant used for LEVADEX. MAP Pharmaceuticals had $79.0 million in cash and cash equivalents as of March 31, 2012, compared to $98.8 million as of December 31, 2011.
"Following receipt of the Complete Response letter from the FDA on March 26 for our LEVADEX NDA submission, we will meet with the FDA in the second quarter of this year and we look forward to gaining clarity around the issues raised in the letter," said Timothy S. Nelson, president and chief executive officer of MAP Pharmaceuticals. "We believe that LEVADEX has the potential to be an important treatment for many of the 30 million Americans who suffer from migraine, and we will continue to closely collaborate with the FDA to address the issues raised in the Complete Response letter as quickly as possible."
Revenues for the first quarter ended March 31, 2012 were $1.0 million, compared to $0.6 million for the same period in 2011. The revenues for both periods were due to amortization of a $60.0 million nonrefundable upfront cash payment received in February 2011, pursuant to a collaboration agreement with Allergan, Inc. entered into in January 2011.
Research and development (R&D) expenses for the first quarter ended March 31, 2012 were $11.0 million, compared to $11.6 million for the same period in 2011. The decrease in R&D expenses for the three months ended March 31, 2012 was caused primarily by a decrease in expenses related to the LEVADEX program, that was partially offset by a one-time $2.8 million expense to purchase a data package relating to the propellant used for LEVADEX, an increase in expenses related to earlier stage research projects and an increase in personnel related expenses.
Sales, general and administrative (SG&A) expenses for the first quarter ended March 31, 2012 were $7.9 million, compared to $4.8 million for the same period in 2011. The increase in SG&A expenses was related primarily to an increase in personnel related expenses primarily within sales and marketing, and an increase in professional services, including activities in preparation for a potential launch of LEVADEX.
For the first quarter ended March 31, 2012, non-cash stock-based compensation and depreciation was approximately $2.7 million.
2012 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."
The Company currently anticipates operating expenses for the remainder of 2012, excluding non-cash charges such as stock-based compensation and depreciation, to be approximately $35 to $37 million. Not included in this financial outlook are potential incremental launch costs which will be determined once the Company has clarity around the Complete Response letter. Collaboration revenues are estimated to be approximately $2.6 million for the remainder of 2012.
About MAP Pharmaceuticals
MAP Pharmaceuticals is a 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 (FDA) reviewed the New Drug Application (NDA) for LEVADEX and on March 26, 2012, the Company received a Complete Response letter with respect to this NDA. 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.
Forward-Looking Statements
In addition to statements of historical facts or statements of current conditions, this press release contains forward-looking statements, including with respect to the process for responding to the FDA's Complete Response letter with respect to the Company's LEVADEX product candidate and the Company's expected cash requirements for the remainder of 2012 described above. 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, including the possibility that the FDA may require additional studies and data with respect to LEVADEX, which may delay the approval of the LEVADEX NDA and require additional capital. 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 Annual Report on Form 10-K for the year ended December 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, lborland@mappharma.com.
MAP PHARMACEUTICALS, INC.
(a development stage enterprise)
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
(Unaudited)
March 31, December 31,
2012 2011
---- ----
ASSETS
Current assets:
Cash and cash
equivalents $79,003 $98,816
Accounts receivable 340 636
Other current
assets 887 763
Total current
assets 80,230 100,215
Property and
equipment, net 7,101 6,786
Other assets 27 27
Restricted
investment 310 310
--- ---
Total assets $87,668 $107,338
======= ========
LIABILITIES AND
STOCKHOLDERS'
EQUITY
Current
liabilities:
Accounts payable
and accrued
liabilities $7,541 $10,793
Current portion of
deferred revenue 3,512 3,349
----- -----
Total current
liabilities 11,053 14,142
Deferred revenue,
less current
portion 52,390 53,581
Other liabilities 34 63
--- ---
Total liabilities 63,477 67,786
Total stockholders'
equity 24,191 39,552
------ ------
Total liabilities
and stockholders'
equity $87,668 $107,338
======= ========
MAP PHARMACEUTICALS, INC.
(a development stage enterprise)
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended March 31,
----------------------------
2012 2011
Collaboration
revenue $1,028 $558
Operating
expenses:
Research and
development 10,962 11,568
Sales, general
and
administrative 7,909 4,843
Total operating
expenses 18,871 16,411
Loss from
operations (17,843) (15,853)
Other expense,
net - (147)
Net loss $(17,843) $(16,000)
Net loss per
share
Basic and
diluted $(0.58) $(0.53)
Weighted average shares outstanding used in
calculating net loss per share
Basic and
diluted 30,620 30,211
Comprehensive
loss $(17,843) $(16,000)
SOURCE MAP Pharmaceuticals, Inc.
