Maxygen, Inc. (Nasdaq:
MAXY - News) today reported financial results for the first
quarter ended March 31, 2003.
For the first quarter of 2003, Maxygen reported a non-GAAP
(formerly pro forma) net loss of $2.9 million, or $0.09 per
share(1), a 55 percent improvement over the company's non-GAAP
net loss of $6.5 million, or $0.20 per share(1), in the
comparable period in 2002. In both cases, these results are
exclusive of stock compensation expense, amortization of
intangible assets and subsidiary preferred stock accretion.
Including such charges, Maxygen reported a net loss applicable
to common stockholders on a GAAP basis of $4.3 million, or $0.12
per share, for the first quarter of 2003 compared to a net loss
applicable to common stockholders of $9.0 million, or $0.27 per
share, in the first quarter of 2002.
Revenue in the first quarter of 2003 was $13.1 million
compared to $9.3 million for the same period in 2002, an
increase of 41 percent. The increase in revenue was primarily
attributable to the receipt of a $2
million product development milestone from Pioneer Hi-Bred to
Verdia, Inc., a wholly owned subsidiary of Maxygen; and a
$2.5 million payment from Hercules to Codexis, Inc., a majority
owned subsidiary of Maxygen, to terminate its agreement
established in 2000 due to a change in Hercules' strategic
direction. Expenses relating to research and development
decreased in the first quarter of 2003 to $14.0 million,
compared to $15.0 million for the same period in 2002 as a
result of cost reduction measures announced in October 2002 that
allow Maxygen to focus the company's resources on high-priority
product candidates while managing cash utilization.
At March 31, 2002, cash, cash equivalents and marketable
securities totaled $225.5 million. This includes $35.2 million
held by Maxygen's subsidiaries Verdia and Codexis.
"We are pleased to remain on track to achieve our financial
targets for this year, including consolidated revenues of $35 to
$40 million, net loss applicable to common stockholders of $44
to $49 million, non-GAAP net loss of $40 to $45 million(2), and
a cash utilization, excluding Codexis and Verdia, of
approximately $30 million(2)," said Russell Howard, Ph.D., Chief
Executive Officer. "While our revenue increased sharply in the
first quarter, this should not be considered an overall trend
due to the nature of the payments made by Pioneer Hi-Bred and
Hercules. On the expense side, we will continue to try to
balance control of spending and maintaining a strong cash
position with investing the appropriate amount of resources to
move our most important product candidates forward."
"We continue to make strong progress with our research and
development pipeline," continued Dr. Howard. "A key aspect of
Maxygen's product portfolio strategy is to analyze existing and
potential human therapeutics to identify deficiencies that limit
their therapeutic use and commercial value. The nature of our
proprietary technologies provide Maxygen with a powerful
platform to create next-generation human therapeutics with
optimized and novel commercial attributes."
"As we continue to move our core therapeutics business
forward, our subsidiaries Codexis and Verdia continue to deliver
success to partners and build in value. In recent months, Verdia
earned a $2 million product development milestone from Pioneer
Hi-Bred, and Codexis' partners have launched five processes
operating at commercial scale for which Codexis receives ongoing
royalty payments."
COMPANY HIGHLIGHTS
Product pipeline continues to move forward
Maxygen's partnered product candidates continue their strong
progress towards potential INDs. These include an interferon
beta in development with Lundbeck for multiple sclerosis and
other CNS diseases and an interferon gamma in development with
InterMune for idiopathic pulmonary fibrosis.
Maxygen's prioritized internal product candidates include an
optimized protein pharmaceutical to treat myelosuppression that
has recently entered preclinical development and an improved
interferon alpha for hepatitis C that is following rapidly
behind.
Optimized protein pharmaceutical to treat myelosuppression
Myelosuppression, or a decreased production of red blood
cells, platelets and some white blood cells is a common side
effect from chemotherapeutic treatments of many forms of cancer.
Myelosuppression puts the patient at significant risk of
bleeding and infection that may lead to serious illness or even
death. Erythropoietin (EPO), granulocyte macrophage-colony
stimulating factor (GM-CSF) and granulocyte-colony stimulating
factor (G-CSF) are three Food and Drug Administration
(FDA)-approved drugs used to decrease the duration of
chemotherapy-induced myelosuppression. Worldwide sales of these
drugs exceeded $8 billion in 2001.
Maxygen has developed a cytokine variant of an existing
protein pharmaceutical that was designed to further reduce the
duration of myelosuppression while maintaining the convenience
of once-weekly dosing. The profile of Maxygen's modified
cytokine drug has been validated in both rat and primate models
of chemotherapy-induced myelosuppression. This product candidate
is currently in preclinical development.
Optimized interferon alpha to treat hepatitis C
Hepatitis C virus (HCV) is a contagious viral infection that
can lead to serious, sometimes fatal, liver disease and causes
an estimated 8,000 to 10,000 deaths annually in the United
States. The current market for interferon alpha for hepatitis C
(including ribivirin) is approximately $1.6 billion worldwide.
Maxygen's improved interferon alphas have been designed to
increase antiviral activity and immune response in patients who
do not respond to existing therapies. In addition to
improvements in the drug's mechanism of action, our PEGylation
technologies may allow us to maintain the convenience and
improved efficacy associated with once-weekly dosing.
Experienced drug development executive joins management team
Elliot Goldstein, M.D., joined Maxygen in February 2003 as
Senior Vice President, Clinical Development and Denmark
Operations. In this role, Dr. Goldstein is responsible for
managing key functions critical to the rapid and efficient
advance of promising pre-clinical candidates from IND up to and
including commercialization, as well as overseeing Maxygen's
Denmark operations. Dr. Goldstein brings to Maxygen extensive
experience as a senior executive leading clinical and commercial
development activities in both biotechnology and pharmaceutical
companies, including SmithKline Beecham (now GlaxoSmithKline)
and British Biotech.
Product development success: Industrial subsidiaries
Verdia
Verdia recently received a $2 million
milestone payment from Pioneer Hi-Bred International Inc. for
successfully delivering an improved corn trait. Verdia
discovered the starting gene and rapidly improved its activity
over 5,000 fold using MolecularBreeding(TM) directed molecular
evolution technologies in order to achieve the desired
commercial attributes. Including this product candidate, Verdia
now has seven product candidates in crop development and testing
with its partners and an additional 13 earlier-stage potential
products in its pipeline.
Codexis
In the first quarter of 2003, Codexis announced that its
partner Novozymes had launched two new products that were
developed using Codexis' proprietary MolecularBreeding(TM)
directed evolution technologies. Novozymes has to date launched
a total of three industrial enzyme products that were developed
using MolecularBreeding(TM) directed evolution technologies.
Codexis currently has over 19 potential products and processes
in its R&D pipeline, including two product candidates and
processes in development. In addition, Codexis has five
processes now operating at commercial scale, each generating
royalty payments.
Non-GAAP Financial Measures
To supplement our consolidated financial statements presented
in accordance with GAAP, we use non-GAAP financial measures of
cash utilization and non-GAAP net loss, which are adjusted from
results based on GAAP to exclude certain expenses. These
non-GAAP financial measures are provided to enhance the user's
overall understanding of our current financial performance and
our prospects for the future. Specifically, we believe the
non-GAAP financial measures provide useful information to both
management and investors by excluding certain expenses that may
not be indicative of our core operating results. Our management
uses non-GAAP net loss and cash utilization in analyzing the
performance of each of our operating business segments and in
analyzing the performance of Maxygen as a whole. In addition,
because we have historically reported certain non-GAAP financial
measures to investors, we believe the inclusion of non-GAAP
financial measures provides consistency in our financial
reporting. These measures should be considered in addition to
results prepared in accordance with GAAP, but should not be
considered a substitute for or superior to GAAP results. The
non-GAAP financial measures included in this press release have
been reconciled to the nearest GAAP measure.