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.
MAP Pharmaceuticals had $103.5
million in cash and cash equivalents as of June 30, 2011, compared to $76.0 million as of December 31, 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
LEVADEX® 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 BOTOX® 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.
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 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, lborland@mappharma.com.
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,
|
|
|
Six Months
Ended June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011
|
|
2010
|
|
|
2011
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue
|
$
|
3,513
|
|
$
|
-
|
|
$
|
37,675
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
7,259
|
|
|
8,242
|
|
|
18,827
|
|
|
18,028
|
|
Sales, general and
administrative
|
|
4,796
|
|
|
3,910
|
|
|
9,639
|
|
|
7,791
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
12,055
|
|
|
12,152
|
|
|
28,466
|
|
|
25,819
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from
operations
|
|
(8,542)
|
|
|
(12,152)
|
|
|
9,209
|
|
|
(25,819)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense,
net
|
|
(84)
|
|
|
(337)
|
|
|
(231)
|
|
|
(728)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
$
|
(8,626)
|
|
$
|
(12,489)
|
|
$
|
8,978
|
|
$
|
(26,547)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
$
|
(0.28)
|
|
$
|
(0.47)
|
|
$
|
0.30
|
|
$
|
(1.01)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
$
|
(0.28)
|
|
$
|
(0.47)
|
|
$
|
0.28
|
|
$
|
(1.01)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
used in computing net income (loss) per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
30,333
|
|
|
26,480
|
|
|
30,272
|
|
|
26,168
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
30,333
|
|
|
26,480
|
|
|
31,595
|
|
|
26,168
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SOURCE MAP Pharmaceuticals, Inc.