EXHIBIT 99.1
[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 FIRST QUARTER 2005
FINANCIAL RESULTS
-- Conference Call and Webcast to be Held Today at 7:00 AM PDT --
SAN DIEGO, MAY 13, 2005 - Halozyme Therapeutics, Inc. (AMEX: HTI), a development
stage biopharmaceutical company focused on the development and commercialization
of recombinant human enzymes, today reported progress and financial results for
the quarter ended March 31, 2005.
FIRST QUARTER 2005 AND SUBSEQUENT HIGHLIGHTS
o Filing a New Drug Application (NDA) with the U.S. Food and Drug
Administration (FDA) on March 23 for Hylenex(TM) (formerly referred to
as Enhanze SC(TM)), the first product in Halozyme's Enhanze(TM)
Technology portfolio, for potential use as a "spreading agent" to
enhance the drug delivery of local anesthesia, contrast agents, and
for subcutaneous fluid replacement (also called hypodermoclysis). The
application was subsequently granted FDA Priority Review status,
pending the formal acceptance of the filing.
o Expanding Baxter Healthcare's and Halozyme's relationship by signing a
development and supply agreement for Hylenex. Subject to approval of
the therapeutic by the FDA, Baxter will fill and finish Hylenex as
well as market, distribute, and sell it in the U.S. and Puerto Rico.
Under terms of the agreement, Halozyme also will grant Baxter a right
of first refusal for additional select developmental stage products
and territories.
o Receiving 510(k) clearance from the FDA for Cumulase(TM) for the
treatment of oocytes to facilitate certain in vitro fertilization
(IVF) procedures. Cumulase is the first and only recombinant human
hyaluronidase product approved in the United States for cumulus
removal in the IVF process.
o Presenting results from new preclinical studies investigating the use of
Halozyme's rHuPH20 hyaluronidase enzyme in conjunction with
chemotherapy at the American Association for Cancer Research in
Anaheim, California. Studies conducted in
collaboration with the University of Trondheim, Norway, showed that
rHuPH20 reduced both tumor interstitial fluid pressure in animal
models and the resistance of cultured human bladder carcinoma
aggregates to a commonly used chemotherapy agent. The company also
announced its selection of bladder cancer as its first therapeutic
target for Chemophase(TM) in oncology.
o Presenting results from new preclinical studies with Halozyme's rHuPH20
hyaluronidase enzyme at the 2005 Association for Research in Vision
and Ophthalmology annual meeting in Fort Lauderdale, Florida.
Preclinical safety and pharmacology animal studies conducted with
Halozyme's rHuPH20 hyaluronidase enzyme showed that when viscoelastic
agents commonly used in cataract surgery were left in the eyes of
animals, injection of Halozyme's rHuPH20 enzyme into the front of the
eye significantly reduced the incidence and severity of intraocular
pressure rises.
o Signing a commercial manufacturing supply agreement with Avid
Bioservices, Inc., under which Avid will manufacture under current
good manufacturing practices Halozyme's first recombinant human enzyme
to be used in Cumulase and Hylenex.
o Bolstering the management team with the addition of Richard C. Yocum, MD,
who joined Halozyme as its new Vice President of Clinical Development
and Medical Affairs. Dr. Yocum brings to Halozyme over 23 years of
experience in clinical drug development, project team management,
clinical research trial design and implementation, and patient care.
FIRST QUARTER 2005 FINANCIAL RESULTS
o Net loss for the first quarter of 2005 was $3.2 million, or $0.06 per
share, compared with a net loss for the first quarter of 2004 of $1.3
million, or $0.08 per share.
o Research and development expenses for the first quarter of 2005 were $2.5
million, compared with $0.7 million for the first quarter of 2004,
reflecting increased research, development and manufacturing expenses
associated with the Company's Cumulase and Hylenex product candidates.
o General and administrative expenses for the first quarter of 2005 were
$0.8 million, compared with $0.5 million for the first quarter of
2004, reflecting increased personnel costs and the costs of being a
public company, including those to support compliance with the
internal control aspects of the Sarbanes-Oxley legislation.
o Cash and cash equivalents were $13.0 million as of March 31, 2005
compared with $16.0 million as of December 31, 2004 and $7.5 million
as of March 31, 2004.
"We continue to make solid progress on all fronts and are meeting our
milestones, including FDA approval of our first product Cumulase, as targeted,"
stated Jonathan Lim, MD, Halozyme's Chairman and CEO. "With the expansion of our
agreement with Baxter and the
signing of our commercial manufacturing agreement with Avid to produce our
recombinant human enzyme for use in Cumulase and Hylenex, we believe Halozyme is
well-positioned and well-capitalized to achieve our clinical and
commercialization goals this year."
Dr. Lim continued, "We are also excited about potentially bringing Chemophase,
Halozyme's oncology drug candidate, into the clinic later this year. Chemophase
is designed to enhance the delivery of chemotherapeutic agents to tumor tissue,
which may renew response to chemotherapy regimens and potentially increase
patient survival. Our goal is to initiate clinical trials in bladder cancer
beginning in the second half of 2005."
CONFERENCE CALL
Halozyme management will host an investment community conference call today to
discuss these topics beginning at 7:00 a.m. PT (10:00 a.m. ET). To participate
via telephone, please call 888-463-4487 for domestic callers, or 706-679-5355
for international callers. 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 6103423. The conference call will be broadcast
live over the Internet at www.halozyme.com and will be available for 30 days.
ABOUT HALOZYME THERAPEUTICS, INC.
Halozyme is a development stage biopharmaceutical company dedicated to
developing and commercializing recombinant human enzymes for the infertility,
ophthalmology, and oncology communities. The company's portfolio of products
under development is based on intellectual property covering the family of human
enzymes known as hyaluronidases. Halozyme's recombinant human enzymes may
replace current animal slaughterhouse-derived enzymes that carry potential risks
of animal pathogen transmission and immunogenicity. The versatility of the first
enzyme, rHuPH20, enables Halozyme to develop the product as a medical device,
drug enhancement agent, and therapeutic biologic.
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 clinical study 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.
[Table to Follow]
HALOZYME THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
CUMULATIVE
THREE MONTHS ENDED FROM INCEPTION
MARCH 31, (FEBRUARY 26, 1998)
2005 2004 TO 2005
-------------------- -------------------- -----------------------------
OPERATING EXPENSES:
Research and development $ 2,462,290 $ 696,581 $ 11,389,588
General and administrative 808,621 510,971 4,580,361
-------------------- -------------------- -----------------------------
Total Operating Expenses 3,270,911 1,207,552 15,969,949
Other income (expense), net 77,834 (76,870) (295,009)
-------------------- -------------------- -----------------------------
LOSS BEFORE INCOME TAXES (3,193,077) (1,284,422) (16,264,958)
Income Tax Expense (Benefit)
- - -
-------------------- -------------------- -----------------------------
NET LOSS $ (3,193,077) $ (1,284,422) $ (16,264,958)
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Net loss per share, basic and diluted $ (0.06) $ (0.08)
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Shares used in computing net loss per share,
basic and diluted 49,575,492 15,441,244
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