[HALOZYME THERAPEUTICS LOGO]
HALOZYME CONTACT INVESTOR RELATIONS CONTACTS
David A. Ramsay Ina McGuinness / Bruce Voss
Chief Financial Officer Lippert/Heilshorn & Associates
(858) 794-8889 (310) 691-7100
dramsay@halozyme.com imcguinness@lhai.com
HALOZYME THERAPEUTICS REPORTS THIRD QUARTER
2004 FINANCIAL RESULTS
SAN DIEGO, NOVEMBER 12, 2004 - Halozyme Therapeutics, Inc. (AMEX: HTI), a
development stage biopharmaceutical company developing and commercializing
recombinant human enzymes, today reported progress and financial results for the
three months ended September 30, 2004.
THIRD QUARTER 2004 AND SUBSEQUENT HIGHLIGHTS
- The signing of an exclusive sales and marketing agreement with
Baxter Healthcare Corporation for commercialization of Halozyme's
investigational therapeutic, Enhanze SC(TM): Baxter will market,
distribute and sell Enhanze SC, Halozyme's recombinant human PH20
hyaluronidase enzyme (rHuPH20), for certain indications in the
United States and Puerto Rico upon approval of the therapeutic by
the U.S. Food and Drug Administration (FDA). Upon approval, Baxter
and Halozyme will be equal partners in the commercialization of the
product.
- The filing of a 510(k) application for Cumulase(TM) with the FDA,
which will evaluate Cumulase for the treatment of oocytes to
facilitate certain in vitro fertilization (IVF) procedures: Cumulase
is an ex vivo formulation of rHuPH20 designed to replace bovine and
ovine enzymes currently used for the preparation of oocytes prior to
IVF during the process of intracytoplasmic sperm injection (ICSI),
in which the enzyme is an essential component. The total Cumulase
market consists of an estimated 500,000 ICSI cycles worldwide in
2004. Halozyme has signed agreements with Cook Ob/Gyn Incorporated,
MediCult A/S and MidAtlantic Diagnostics, Inc. to distribute
Cumulase worldwide.
- The receipt of ISO 13485:2003 certification: ISO 13485:2003
addresses the establishment of a quality system focused on medical
devices, and is the first step in obtaining the CE (European
Conformity) Mark authorizing distribution to the 25 European Union
(EU) and three European Free Trade Association (EFTA) member states.
With this registration, Halozyme is well positioned to move forward
with its Cumulase medical device.
- more -
- The reporting of Cumulase study results at the Technology Pavilion
of the American Society of Reproductive Medicine (ASRM) 2004 Annual
Meeting in Philadelphia: Studies from Stanford University revealed
that after extended exposure to Cumulase, murine oocytes (eggs)
demonstrated fertilization rates similar to natural IVF, whereas in
the same time period, oocytes exposed to bovine hyaluronidase
experienced approximately a 50 percent decrease in viability
relative to natural IVF or Cumulase treated oocytes.
- The completion of a $13.9 million private placement: The Company
issued an aggregate of approximately 7.9 million shares of common
stock at $1.75 per share and warrants to purchase up to 2.4 million
additional shares of common stock at an exercise price of $2.25 per
share. The transaction closed on October 13, 2004.
- The listing of Halozyme's common stock on the American Stock
Exchange(R) (Amex(R)): Halozyme's common stock commenced trading on
the Amex under the symbol "HTI" on Monday, November 1, 2004.
THIRD QUARTER 2004 FINANCIAL RESULTS
- Net loss for the third quarter of 2004 was $3.3 million, or $0.08
per share, compared to a net loss for the third quarter of 2003 of
$0.4 million, or $0.05 per share.
- Research and development expenses for the third quarter of 2004 were
$2.6 million, compared to $0.3 million for the third quarter of
2003, reflecting increased research and development expenses
associated with the development and manufacturing of the Company's
Cumulase and Enhanze SC product candidates.
- General and administrative expenses for the third quarter of 2004
were $0.7 million, compared to $0.2 million for the third quarter of
2003, reflecting increased personnel costs and the costs of being a
public company.
- Cash and cash equivalents were $3.5 million at September 30, 2004
compared to $5.9 million at June 30, 2004.
Halozyme's lead product candidates are Cumulase, which is designed as an aid in
the in vitro fertilization process and Enhanze SC, which is designed as a
spreading agent for local anesthesia in cataract surgery. Both product
candidates target established markets, are based on a common, proprietary
technology platform and offer significant competitive safety and potency
advantages compared to current alternatives.
- more -
"Our accomplishments this quarter, and year to date, highlight the tremendous
therapeutic potential of Halozyme's recombinant human hyaluronidase in all of
its forms," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "The execution
of key licensing deals, the filing of our 510(k) application for Cumulase(TM) in
the third quarter of 2004, and our planned filing of a New Drug Application for
Enhanze SC(TM) in the first quarter of 2005 keep us on track to achieve our
stated commercialization goals for Cumulase and Enhanze SC, our first two
product candidates."
CONFERENCE CALL
Jonathan Lim, MD, Chairman and Chief Executive Officer, Gregory Frost, Vice
President and Chief Scientific Officer, and David Ramsay, Vice President and
Chief Financial Officer, will host an investment community conference call today
beginning at 8:00 a.m. PT (11:00 a.m. ET) to discuss the results and provide a
business update.
Individuals interested in participating in the conference call may do so by
dialing 888-463-4487 for domestic callers, or 706-679-5355 for international
callers. Those interested in listening to the conference call live via the
Internet may do so by visiting the Investor Relations section of the Company's
website at www.halozyme.com.
A replay will be available on Halozyme's website for 30 days. A telephone replay
will be available for 48 hours by dialing 800-642-1687 from the U.S., or
706-645-9291 for international callers, and entering reservation number 1694457.
ABOUT HALOZYME THERAPEUTICS, INC.
Halozyme Therapeutics, Inc. is a development stage biopharmaceutical company
dedicated to developing and commercializing recombinant human enzymes for the
infertility (Cumulase), ophthalmology (Enhanze SC), and oncology
(Chemophase(TM)) markets. The company's portfolio of products in development is
based on intellectual property covering the family of human enzymes known as
hyaluronidases. Halozyme is developing the first recombinant human hyaluronidase
(rHuPH20) as a medical device (Cumulase), drug enhancement agent (Enhanze SC)
and therapeutic biologic (Chemophase).
SAFE HARBOR STATEMENT
In addition to historical information, the statements set forth above include
forward-looking statements (including, without limitation, statements concerning
the Company's products under development, product development plans and
regulatory strategy and the regulatory filing and potential launch dates
assuming regulatory approval) that involve risk and uncertainties that could
cause actual results to differ materially from those in the forward-looking
statements. The forward-looking statements are also identified through use of
the words "believe," "enable," "may," "will," "could," "intends," "estimate,"
"anticipate," "plan," "predict," "probable," "potential," "possible," "should,"
"continue," and other words of similar meaning. Actual results could differ
materially from the expectations contained in forward-looking statements as a
result of several factors, including regulatory approval requirements and
competitive conditions. These and other factors that may result in differences
are discussed in greater detail in the company's reports on Forms 10-KSB, 10-QSB
and other filings with the Securities and Exchange Commission.
(FINANCIAL TABLE FOLLOWS)
HALOZYME THERAPEUTICS, INC.
A DEVELOPMENT STAGE COMPANY
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
THREE MONTHS ENDED NINE MONTHS ENDED
SEPTEMBER 30, SEPTEMBER 30,
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2004 2003 2004 2003
---- ---- ---- ----
EXPENSES:
Research and development $ 2,598,335 $ 254,903 $ 4,816,492 $ 764,007
General and administrative 664,896 153,327 1,743,417 268,489
------------ ------------ ------------ ------------
Total Expenses 3,263,231 408,230 6,559,909 1,032,496
Other income (expense), net 10,086 (30,784) (52,355) (80,985)
------------ ------------ ------------ ------------
LOSS BEFORE INCOME TAXES (3,253,145) (439,014) (6,612,264) (1,113,481)
Income Tax Expense -- -- -- --
------------ ------------ ------------ ------------
NET LOSS $ (3,253,145) $ (439,014) $ (6,612,264) $ (1,113,481)
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Net loss per share, basic and diluted $ (0.08) $ (0.05) $ (0.21) $ (0.14)
============ ============ ============ ============
Shares used in computing net loss per share,
basic and diluted 39,573,312 8,196,362 31,512,015 8,196,362
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