31.07.2008 20:03:00
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Maxygen Reports Second Quarter 2008 Financial Results
Maxygen, Inc. (Nasdaq:MAXY), a biotechnology company focused on the
development of improved protein drugs, today announced financial results
for the quarter ended June 30, 2008 and issued an update on its business.
Second Quarter 2008 Financial Results
Maxygen reported a GAAP net loss of $28.1 million, or $0.76 per share,
for the second quarter 2008 as compared to a GAAP net loss of $15.7
million, or $0.43 per share, for the comparable period in 2007. The
increased loss was primarily due to a $12.2 million charge for
impairment of goodwill. This estimated charge was incurred due to a
goodwill impairment test that determined the market value of the company
was less than the total value of its net assets.
Revenue for the second quarter was $1.2 million, compared to $2.1
million for the same period in 2007. Proceeds from the sale of Maxygen’s
hemophilia assets and other technology rights to Bayer HealthCare will
be recognized in the third quarter. Total research and development and
general and administrative expenses were $17.6 million in the second
quarter of 2008 compared to $19.9 million in the second quarter of 2007.
Excluding the impact of non-cash stock compensation expense under SFAS
123(R) and the goodwill impairment, Maxygen reported a non-GAAP net loss
of approximately $13.5 million, or $0.37 per share, in the second
quarter of 2008, compared to a non-GAAP net loss of approximately $14.0
million, or $0.38 per share, in the second quarter of 2007 (see Footnote
A).
At June 30, 2008, cash, cash equivalents and marketable securities
totaled $122.4 million; this amount does not yet include proceeds from
the Bayer Healthcare agreement.
Business Update
On July 2, 2008, Maxygen announced an agreement with Bayer HealthCare
under which Bayer acquired Maxygen’s
hemophilia assets and other technology rights. In return Maxygen
received an initial payment of $90 million and the potential to receive
additional milestone payments of up to $30 million. MAXY-VII is a novel
recombinant Factor VIIa protein created using Maxygen’s
MolecularBreeding™ directed evolution
platform. Post-closing activities are ongoing, including technology
transfer of MAXY-VII-related knowledge and materials.
As a result of reduced expenditure on the MAXY-VII program due to the
Bayer agreement, Maxygen has lowered its operating cash utilization
projection to $40-45 million for the full
year 2008. Operating cash utilization, a non-GAAP financial measure, is
defined in Footnote A.
The company also announced today that Santosh Vetticaden, PhD, MD,
Maxygen’s chief medical officer, will resign
effective August 15, 2008. In addition to his current role as the company’s
chief operating officer, Elliot Goldstein, MD, will reassume the role of
chief medical officer and will again hold direct responsibility for the
company’s clinical and regulatory operations
on an ongoing basis.
"I thank Santosh for his many contributions to
the company during his time here,” said
Russell Howard, chief executive officer of Maxygen. "He
was the driving force behind achieving our goal of filing a Clinical
Trial Authorization for MAXY-VII and helped establish the clinical
regulatory plan for the program.”
Also during the second quarter, the company reported continued progress
in its two lead programs, MAXY-G34 for chemotherapy-induced neutropenia
and MAXY-4 for the treatment of a broad array of autoimmune disorders,
including rheumatoid arthritis. The Phase IIa trial of MAXY-G34 remains
on track to be completed in the first quarter of 2009. The company
expects to complete preclinical proof-of-concept studies for its MAXY-4
program by the end of this calendar year.
Conference Call
Maxygen will host a conference call today to discuss second quarter 2008
financial results at 4:30 p.m. ET (1:30 p.m. PT). Participants in the
U.S. can access the call by dialing 866.202.4367 and using the passcode
62998376. International participants can dial 617.213.8845 and use the
same passcode. A live webcast of the conference call will be available
on the Maxygen web site at www.maxygen.com/webcasts.
Telephone and webcast replays of the conference call will be available
until August 31, 2008. To access the telephone replay, dial 888.286.8010
(U.S.) or 617.801.6888 (international) and use the passcode 37824983. To
access the webcast archive, go to www.maxygen.com/webcasts.
About Maxygen
Maxygen is a biopharmaceutical company focused on developing improved
versions of protein drugs. The company’s lead
program, MAXY-G34, is designed to be an improved long-acting G-CSF for
the treatment of neutropenia. MAXY-G34 is currently in Phase II clinical
trials. Maxygen also has a MAXY-4 program, under which it is exploring
new CTLA4-Ig product candidates for the treatment of a broad array of
autoimmune disorders, including rheumatoid arthritis. Maxygen uses its
proprietary DNA shuffling technology and extensive protein modification
expertise to pursue the creation of biosuperior proteins. www.maxygen.com Forward-Looking Statements
This news release contains forward-looking statements about our research
and business prospects and financial position, including those relating
to our ability to develop any human therapeutic products suitable for
commercialization; our ability or plans to commence or continue the
preclinical or clinical development of any of our product candidates,
including MAXY-G34 and MAXY-4; the timing and status of any such
development, including the expected completion of our Phase IIa trial of
MAXY-G34; and our projected operating cash utilization for 2008. Such
statements involve risks and uncertainties that may cause results to
differ materially from those set forth in these statements. Among other
things these risks and uncertainties include, but are not limited to,
changing research and business priorities, the inherent uncertainties of
pharmaceutical research and drug development, our ability to develop
human therapeutic drugs in an increasingly competitive biotechnology
industry and the uncertain timing of such development, the development
of superior products by competitors, and our ability to establish and
maintain research and commercialization collaborations and manufacturing
arrangements. These and other risk factors are more fully discussed in
our Form 10-K for the year ended December 31, 2007, including under the
caption "Risk Factors”,
and in our other periodic SEC reports, all of which are available from
Maxygen at www.maxygen.com. Maxygen
disclaims any obligation to update or revise any forward-looking
statement contained in this release as a result of new information or
future events or developments.
Selected Consolidated Financial Information
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
Three Months Ended
Six Months Ended June 30, June 30, 2008
2007 2008
2007
(unaudited)
(unaudited)
Revenues:
Collaborative research and development revenue
$ --
$ 874
$ --
$ 8,471
Revenue from related party
120
--
277
556
Grant revenue
1,037
1,207
2,323
2,146
Total revenues
1,157
2,081
2,600
11,173
Expenses:
Research and development
12,534
16,343
25,640
30,943
General and administrative
5,031
3,528
8,544
7,859
Goodwill impairment
12,192
--
12,192
--
Restructuring charge
266
--
799
--
Total operating expenses
30,023
19,871
47,175
38,802
Loss from operations
(28,866)
(17,790)
(44,575)
(27,629)
Interest income and other (expense), net
759
2,118
2,750
4,292
Net loss
$(28,107)
$(15,672)
$(41,825)
$(23,337)
Basic and diluted net loss per share
$ (0.76)
$ (0.43)
$ (1.13)
$ (0.64)
Shares used in computing basic and diluted net loss per share
37,046
36,791
37,021
36,688
Condensed Consolidated Balance Sheets
(in thousands)
June 30,
December 31, 2008 2007
(unaudited)
(Note 1)
Cash, cash equivalents and marketable securities
$
122,354
$
145,813
Receivables, prepaid and other assets
2,098
11,644
Property and equipment, net
2,673
3,060
Goodwill
--
12,192
Total assets
$
127,125
$
172,709
Other liabilities
$
11,047
$
14,802
Restructuring liabilities
46
4,413
Stockholders' equity
116,032
153,494
Total liabilities and stockholders’ equity
$
127,125
$
172,709
Note 1: Derived from consolidated audited financial statements as
of December 31, 2007.
Footnotes
(A)
Non-GAAP Financial Measures
To supplement our consolidated financial statements, we have
provided non-GAAP net loss and net loss per share. We have also
provided a projection of cash utilization, a non-GAAP financial
measure. The presentation of this financial information is not
intended to be considered in isolation or as a substitute for, or
superior to, the financial information prepared and presented in
accordance with GAAP.
Non-GAAP net loss and net loss per share excludes the impact of
stock compensation expense and the impairment of goodwill. We
believe that it is useful as a supplemental measure in assessing the
performance of our business and is used by our management to
evaluate business results. We excluded goodwill impairment for the
three and six month periods ended June 30, 2008 because it is not
representative of the on-going results of operations of our
business. Below is a reconciliation of GAAP and non-GAAP net loss
and net loss per share (in thousands, except per share amounts):
Three Months Ended
Six Months Ended
June 30,
June 30,
2008
2007
2008
2007
Net loss
$
(28,107
)
$
(15,672
)
$
(41,825
)
$
(23,337
)
Goodwill impairment
12,192
--
12,192
--
Stock compensation expense
2,380
1,714
3,611
3,567
Non-GAAP net loss
$
(13,535
)
$
(13,958
)
$
(26,022
)
$
(19,770
)
Shares used in computing Non-GAAP basic and diluted net loss per
share
37,046
36,791
37,021
36,688
Non-GAAP basic and diluted net loss per share
$
(0.37
)
$
(0.38
)
$
(0.70
)
$
(0.54
)
Operating cash utilization is a non-GAAP measure that is defined
as net income/(loss) as adjusted to include capital expenditures
and exclude the impact of stock compensation expense, the
impairment of goodwill, depreciation, and the $90 million of
proceeds received from Bayer. We believe that operating cash
utilization is a useful measure for investors, as it indicates the
projected rate at which we will use our total cash and investment
balances in our general business activities.
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