MOUNTAIN VIEW, Calif.,
March 29, 2012 /PRNewswire/ -- MAP
Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced financial
results for the fourth quarter and year ended December 31, 2011.
The net loss for the fourth quarter ended December 31, 2011 was $13.8 million, compared to a net loss of
$13.9 million during the same period
in 2010. The net loss for the year ended December 31, 2011 was $32.9 million, compared to a net loss of
$54.7 million for the year ended
December 31, 2010. The decrease in
net loss for the year ended December 31,
2011 was primarily due to recognition of a $20.0 million milestone payment received in
August 2011 and amortization of a
$60.0 million non-refundable upfront
cash payment received in February
2011, both pursuant to a collaboration agreement with
Allergan, Inc. entered into in February
2011, compared to no collaboration revenue for the year
ended December 31, 2010.
The Company had $98.8 million in
cash and cash equivalents as of December 31,
2011, compared to $76.0
million as of December 31, 2010.
The Company also announced today that it will restate its
interim unaudited financial statements for the first three quarters
of 2011 to correct the accounting treatment for the non-refundable
$60.0 million upfront cash payment
received in February 2011 (the
"Upfront Payment") pursuant to the collaboration agreement with
Allergan. The restatement relates to the timing of revenue
recognition for the Upfront Payment and not the total amount of
revenue ultimately to be recorded by the Company. The
restatement will have no impact on the Company's previously
reported cash position, total assets or operating expenses.
The Company previously recognized $34.2 million of the Upfront Payment as
collaboration revenue in the quarter ended March 31, 2011. The financial results presented
in this press release incorporate the adjustments described above
relating to the restatement.
"We made significant progress with the LEVADEX program
throughout 2011, and recently received a Complete Response letter
from the FDA," said Timothy S.
Nelson, president and chief executive officer of MAP
Pharmaceuticals. "We are committed to making this important new
therapy available to people who experience migraine, and will
continue to work closely with the FDA to address the issues raised
in the Complete Response letter as quickly as possible."
2011 Accomplishments
- 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).
On March 26, 2012, the FDA
issued a Complete Response letter related to the LEVADEX NDA.
- Announced a strategic collaboration with Allergan to co-promote
LEVADEX, upon potential approval, to neurologists and pain
specialists in the United States
for the acute treatment of migraine. Allergan later exercised
an option to expand the collaboration to include Canada for neurologists and pain specialists.
The Company received a $60.0 million
non-refundable upfront cash payment in connection with the
execution of the collaboration agreement. The acceptance for filing
of the NDA for LEVADEX triggered an additional $20.0 million milestone payment. The
collaboration with Allergan provides the potential to expand the
detailing of LEVADEX to a broader number of neurologists and pain
specialists in the United States.
Following potential approval of LEVADEX, the Company will
build a 50-person field sales force targeting neurologists and pain
specialists to be complemented by Allergan's existing U.S. sales
force dedicated to headache specialists using BOTOX® for the
preventative treatment of headaches in patients with chronic
migraine. The Company 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.
- Appointed Frederick H. Graff to
the newly created position of Vice President, Commercial
Operations. Mr. Graff brings to the Company more than 25 years of
experience in commercial sales and marketing of pharmaceutical
products.
- Announced the issuance of U.S. Patent No. 7,994,197, titled
"Method of Therapeutic Administration of DHE to Enable Rapid Relief
of Migraine while Minimizing Side Effect Profile" by the United
States Patent and Trademark Office. The patent, which expires in
2028, results from the Company's discovery that dihydroergotamine
(DHE) can be administered to achieve pharmacokinetic profiles that
result in both rapid efficacy and minimal side effects. LEVADEX
targets the pharmacokinetic profiles described in this patent.
- Published results from the Phase 3 FREEDOM-301 study of LEVADEX
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.
Fourth Quarter and 2011 Year End Financial Results
Revenues for the quarter and year ended December 31, 2011 were $0.8 million and $23.1
million, respectively, compared to $0.0 and $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, of which the Company recognized
$0.8 million and $3.1 million, respectively, as collaboration
revenue for the quarter and year ended December 31, 2011. In addition, in August 2011, Allergan paid the Company a
milestone payment of $20.0 million,
which was recognized as collaboration revenue for the year ended
December 31, 2011.
Research and development (R&D) expenses for the fourth
quarter ended December 31, 2011 were
$8.1 million, compared to
$9.7 million for the same period in
2010. The decrease in R&D expenses during this period was due
primarily to a decrease in expenses related to the LEVADEX program,
a decrease in personnel-related expenses, including stock-based
compensation, partially offset by an increase in expenses related
to earlier stage research projects.
R&D expenses for the year ended December 31, 2011 were $33.7 million, compared to $37.8 million for the same period in 2010. The
decrease in R&D expenses during this period was due primarily
to a decrease in expenses related to the LEVADEX program, partially
offset by an increase in personnel-related expenses, including
stock-based compensation, primarily due to an increase in
manufacturing-related headcount in support of commercial readiness
activities, and an increase in expenses related to earlier stage
research projects.
Sales, general and administrative (SG&A) expenses for the
fourth quarter ended December 31,
2011 were $6.5 million,
compared to $4.0 million for the same
period in 2010. The increase in SG&A expenses during this
period was due primarily to an increase in professional services,
including LEVADEX-related market research activities, and an
increase in personnel-related expenses including stock-based
compensation.
SG&A expenses for the year ended December 31, 2011 were $22.1 million, compared to $15.7 million for the same period in 2010. The
increase in SG&A expenses during this period was due primarily
to an increase in personnel-related expenses including stock-based
compensation, and an increase in professional services, including
LEVADEX related market research activities.
For the fourth quarter and year ended December 31, 2011, non-cash stock-based
compensation and depreciation were approximately $2.3 million and $8.8
million, respectively.
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 reviewed the
New Drug Application for LEVADEX and on March 26, 2012, the Company received a Complete
Response letter. 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, and relating to the
Company's patent rights. 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
September 30, 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)
|
|
CONSOLIDATED
BALANCE SHEETS
|
|
|
(In
thousands)
|
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
|
2011
|
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
98,816
|
|
|
$
|
76,007
|
|
|
Accounts
receivable
|
|
|
636
|
|
|
|
-
|
|
|
Other current
assets
|
|
|
763
|
|
|
|
644
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
|
100,215
|
|
|
|
76,651
|
|
|
Property and equipment,
net
|
|
|
6,786
|
|
|
|
5,803
|
|
|
Other assets
|
|
|
27
|
|
|
|
30
|
|
|
Restricted
investment
|
|
|
310
|
|
|
|
310
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
107,338
|
|
|
$
|
82,794
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
10,793
|
|
|
$
|
12,440
|
|
|
Debt
|
|
|
-
|
|
|
|
7,581
|
|
|
Current portion of
deferred revenue
|
|
|
3,349
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
|
14,142
|
|
|
|
20,021
|
|
|
Deferred revenue, less
current portion
|
|
|
53,581
|
|
|
|
-
|
|
|
Other
liabilities
|
|
|
63
|
|
|
|
117
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
67,786
|
|
|
|
20,138
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders’
equity
|
|
|
39,552
|
|
|
|
62,656
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders’ equity
|
|
$
|
107,338
|
|
|
$
|
82,794
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
MAP
PHARMACEUTICALS, INC.
|
|
(a
development stage enterprise)
|
|
CONSOLIDATED
STATEMENTS OF OPERATIONS
|
|
(In
thousands, except per share amounts)
|
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended December 31,
|
|
|
Twelve
Months Ended December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2011
|
|
2010
|
|
|
2011
|
|
2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue
|
$
|
837
|
|
$
|
-
|
|
$
|
23,069
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
8,111
|
|
|
9,738
|
|
|
33,663
|
|
|
37,775
|
|
Sales, general and
administrative
|
|
6,531
|
|
|
4,001
|
|
|
22,060
|
|
|
15,713
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
14,642
|
|
|
13,739
|
|
|
55,723
|
|
|
53,488
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(13,805)
|
|
|
(13,739)
|
|
|
(32,654)
|
|
|
(53,488)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense,
net
|
|
(15)
|
|
|
(209)
|
|
|
(285)
|
|
|
(1,185)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(13,820)
|
|
$
|
(13,948)
|
|
$
|
(32,939)
|
|
$
|
(54,673)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
$
|
(0.45)
|
|
$
|
(0.46)
|
|
$
|
(1.08)
|
|
$
|
(2.01)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing net loss per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
30,522
|
|
|
30,043
|
|
|
30,377
|
|
|
27,261
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SOURCE MAP Pharmaceuticals, Inc.