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.