MOUNTAIN VIEW, Calif.,
July 24, 2012 /PRNewswire/
-- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) today announced
financial results for the second quarter ended June 30, 2012.
The net loss for the three months ended June 30, 2012 was $13.3
million, compared to a net loss of $11.3 million during the same period in
2011. The net loss for the six months ended June 30, 2012 was $31.1
million, compared to a net loss of $27.3 million during the same period in 2011. As
of June 30, 2012, MAP Pharmaceuticals
had cash and cash equivalents of $68.4
million, compared to $79.0
million as of March 31,
2012.
"As we previously announced, in the second quarter we had an
End-of-Review meeting with the U.S. Food and Drug Administration,"
said Timothy S. Nelson, president
and chief executive officer of MAP Pharmaceuticals. "We reduced our
operating expenses in the second quarter as we work to address the
outstanding items identified by the FDA and we believe we are on
track to file the resubmission in the late third quarter/early
fourth quarter 2012 timeframe. If approved, we believe that LEVADEX
has the potential to provide an important treatment option to many
of the 30 million Americans who experience migraine."
2012 Year-to-Date Key Developments:
- Announced that the U.S. Food and Drug Administration (FDA)
issued a Complete Response letter on March
26, 2012 to its New Drug Application (NDA) for LEVADEX®
inhalation aerosol. In the Complete Response letter, the FDA
requested that the Company address issues relating to chemistry,
manufacturing and controls (CMC) and observations from a facility
inspection of a third party manufacturer. The FDA also indicated
that it had not been able to complete review of inhaler usability
information requested late in the review cycle by the FDA. The FDA
did not cite any clinical safety or efficacy issues, nor did the
FDA request that any additional clinical studies be conducted prior
to approval.
- Announced an End-of-Review meeting with the FDA for the LEVADEX
NDA. Based upon the meeting with the FDA, the Company is in the
process of addressing the issues in the Complete Response letter
and plans to resubmit to the FDA in the late third quarter/early
fourth quarter 2012 timeframe.
- Appointed W. James O'Shea to the Board of Directors, bringing
to the Board 35 years of healthcare industry experience in product
commercialization and operations.
- Announced the issuance of U.S. Patent No. 8,119,639 and U.S.
Patent No. 8,148,377, both titled "Method of Therapeutic
Administration of DHE to Enable Rapid Relief of Migraine while
Minimizing Side Effect Profile." The patents, which expire in 2028,
claim novel pharmacokinetic profiles and result from the Company's
discovery that dihydroergotamine (DHE) can be administered to
achieve pharmacokinetic profiles that result in rapid efficacy
while minimizing side effects that are typically seen with other
migraine drugs.
Three and Six Month Financial Results
Revenues for the three and six months ended June 30, 2012 were $0.9
million and $1.9 million,
respectively, compared to $0.8
million and $1.4 million for
the same periods in 2011. The revenues for both years 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 three and
six months ended June 30, 2012 were
$7.8 million and $18.7 million, respectively, compared to
$7.3 million and $18.8 million for the same periods in 2011. For
the three months ended June 30, 2012
compared to the same period in 2011, the increase in R&D
expenses was due primarily to an increase in expenses related to
early stage research projects, partially offset by a decrease in
expenses related to the LEVADEX program. For the six months ended
June 30, 2012 compared to the same
period in 2011, the decrease in R&D expenses was due primarily
to a decrease in expenses related to the LEVADEX program, partially
offset by an increase in expenses related to early stage research
projects and an increase in personnel related expenses, including
stock-based compensation.
Sales, general and administrative (SG&A) expenses for the
three and six months ended June 30,
2012 were $6.4 million and
$14.3 million, respectively, compared
to $4.8 million and $9.6 million for the same periods in 2011. For
the three months ended June 30, 2012
compared to the same period in 2011, the increase in SG&A
expenses was due primarily to an increase in personnel related
expenses primarily within sales and marketing, including
stock-based compensation, partially offset by a decrease in
professional services. For the six months ended June 30, 2012 compared to the same period in
2011, the increase in SG&A expenses was due primarily to an
increase in personnel related expenses primarily within sales and
marketing, including stock-based compensation, and an increase in
professional services, including activities in preparation for a
potential launch of LEVADEX.
For the three and six months ended June
30, 2012, non-cash stock-based compensation and depreciation
were approximately $2.5 million and
$5.2 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 (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. The Company completed an
End-of-Review meeting with the FDA and plans to resubmit in the
late third quarter/early fourth quarter 2012 timeframe. 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, without limitation, statements regarding the
process and timing for responding to the FDA's Complete Response
letter with respect to the Company's 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, 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 Quarterly Report on Form 10-Q for
the quarter ended March 31, 2012,
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,
|
|
|
2012
|
|
|
2011
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash and
cash equivalents
|
|
$
|
68,419
|
|
|
$
|
98,816
|
Accounts
receivable
|
|
|
229
|
|
|
|
636
|
Other
current assets
|
|
|
743
|
|
|
|
763
|
|
|
|
|
|
|
|
|
Total
current assets
|
|
|
69,391
|
|
|
|
100,215
|
Property
and equipment, net
|
|
|
6,720
|
|
|
|
6,786
|
Other
assets
|
|
|
27
|
|
|
|
27
|
Restricted
investment
|
|
|
310
|
|
|
|
310
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
76,448
|
|
|
$
|
107,338
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities
|
|
$
|
7,813
|
|
|
$
|
10,793
|
Current
portion of deferred revenue
|
|
|
3,512
|
|
|
|
3,349
|
|
|
|
|
|
|
Total
current liabilities
|
|
|
11,325
|
|
|
|
14,142
|
Deferred
revenue, less current portion
|
|
|
51,512
|
|
|
|
53,581
|
Other
liabilities
|
|
|
-
|
|
|
|
63
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
62,837
|
|
|
|
67,786
|
|
|
|
|
|
|
|
|
Total
stockholders' equity
|
|
|
13,611
|
|
|
|
39,552
|
|
|
|
|
|
|
|
Total
liabilities and stockholders' equity
|
|
$
|
76,448
|
|
|
$
|
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
June
30,
|
|
|
Six
Months Ended
June
30,
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2012
|
|
2011
|
|
|
2012
|
|
2011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue
|
$
|
878
|
|
$
|
837
|
|
$
|
1,906
|
|
$
|
1,395
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
7,773
|
|
|
7,259
|
|
|
18,735
|
|
|
18,827
|
Sales, general and
administrative
|
|
6,399
|
|
|
4,796
|
|
|
14,308
|
|
|
9,639
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
14,172
|
|
|
12,055
|
|
|
33,043
|
|
|
28,466
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(13,294)
|
|
|
(11,218)
|
|
|
(31,137)
|
|
|
(27,071)
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense), net
|
|
2
|
|
|
(84)
|
|
|
2
|
|
|
(231)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$
|
(13,292)
|
|
$
|
(11,302)
|
|
$
|
(31,135)
|
|
$
|
(27,302)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share - basic and diluted
|
$
|
(0.43)
|
|
$
|
(0.37)
|
|
$
|
(1.02)
|
|
$
|
(0.90)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding used in computing net loss per share -
basic and diluted
|
|
30,698
|
|
|
30,333
|
|
|
30,659
|
|
|
30,272
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
comprehensive loss
|
$
|
(13,292)
|
|
$
|
(11,302)
|
|
$
|
(31,135)
|
|
$
|
(27,302)
|
|
|
|
|
|
|
|
|
|
|
|
|
SOURCE MAP Pharmaceuticals, Inc.