Exhibit 99.2
(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
AUGUST 10, 2004
HALOZYME THERAPEUTICS REPORTS SECOND QUARTER
FINANCIAL RESULTS
SAN DIEGO, AUGUST 16, 2004 - Halozyme Therapeutics, Inc. (OTCBB: HZYM), a
development stage biopharmaceutical company developing and commercializing
recombinant human enzymes, today reported financial results for the three months
ended June 30, 2004.
SECOND QUARTER 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 for certain indications in the
United States and Puerto Rico upon approval of the therapeutic by
the Food and Drug Administration (FDA). Under the terms of the
agreement, Baxter and Halozyme will share the gross profit, defined
as net revenue less cost of goods sold, equally.
- The signing of non-exclusive, global distribution agreements with
three of the leading in vitro fertilization (IVF) suppliers for
commercialization of Halozyme's investigational medical device,
CUMULASE(TM): Cook Ob/Gyn Incorporated, MediCult A/S, and
MidAtlantic Diagnostics, Inc., to distribute CUMULASE worldwide.
CUMULASE will be the first and only synthetic alternative to impure
slaughterhouse-derived enzymes to treat eggs prior to certain IVF
procedures.
- Changes to Halozyme's Board of Directors and Scientific Advisory
Board: Halozyme has added Robert Engler, MD, and Kenneth Kelley to
the board, while Ira Lechner and Edward Mercaldo stepped down.
Halozyme added Daniel Von Hoff, MD, a leading expert in the field of
oncology, and Gerhard Baumgartner, MD, a pioneer in the clinical
investigation of hyaluronidase enzymes in the treatment of cancer
patients, to its Scientific Advisory Board. Both will advise the
company in the development of
CHEMOPHASE(TM), Halozyme's therapeutic biologic targeting oncology
applications.
- The Company noted that its SB-2 registration statement covering
resales by holders of shares issued in its recent private financing
and shares issuable upon exercise of warrants issued in that
financing has been declared effective by the Securities and Exchange
Commission.
FINANCIAL RESULTS
- Net loss for the second quarter of 2004 was $2.1 million, or $0.05
per share, compared to a net loss for the second quarter of 2003 of
$0.4 million, or $0.05 per share.
- Research and development expenses for the second quarter of 2004
were $1.5 million, compared to $0.3 million for the second quarter
of 2003, reflecting increased research and development expenses
associated with the development of the Company's Cumulase(TM) and
Enhanze SC(TM) product candidates.
- General and administrative expenses for the second quarter of 2004
were $0.6 million, compared to $0.1 million for the second quarter
of 2003, reflecting increased personnel costs and the additional
costs of being a public company.
- Cash and cash equivalents were $5.9 million at June 30, 2004. Net
cash burn for the second quarter of 2004 was $1.5 million.
Halozyme's lead product candidates are Cumulase(TM) and Enhanze SC(TM). Cumulase
is designed to use as an aid in the in vitro fertilization process and Enhanze
SC(TM) is designed for use as a spreading agent for local anesthesia in cataract
surgery. Both products target established markets, are based on a common,
proprietary technology platform and offer significant competitive safety and
potency advantages compared with current alternatives.
"This is a very exciting period for Halozyme. In the second and third quarters
of 2004, we have been able to execute key licensing deals to achieve our stated
commercialization goals for CUMULASE and ENHANZE SC, our first two products,"
said Jonathan E. Lim, MD, Halozyme's Chairman and CEO. "We also remain on track
to file a 510(k) application for CUMULASE in the fourth quarter of 2004, and a
New Drug Application for ENHANZE SC in the first quarter of 2005."
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 in
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 risks of animal
pathogen contamination and immunogenicity. The versatility of the first enzyme,
rHuPH20, may enable Halozyme to simultaneously market 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 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 TABLES FOLLOW)
HALOZYME THERAPEUTICS, INC.
A DEVELOPMENT STAGE COMPANY
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30, JUNE 30,
2004 2003 2004 2003
EXPENSES:
Research and development ................... $ 1,521,576 $ 297,151 $ 2,218,157 $ 509,104
General and administrative ................. 567,550 75,765 1,078,521 115,162
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Total Expenses ............................. 2,089,126 372,916 3,296,678 624,266
Other income (expense), net ................ 14,429 (30,040) (62,441) (50,201)
------------ ------------ ------------ ------------
LOSS BEFORE INCOME TAXES ................... (2,074,697) (402,956) (3,359,119) (674,467)
Income Tax Expense ......................... -- -- -- --
------------ ------------ ------------ ------------
NET LOSS ................................... $ (2,074,697) $ (402,956) $ (3,359,119) $ (674,467)
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Net loss per share, basic and diluted ...... $ (0.05) $ (0.05) $ (0.12) $ (0.08)
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Shares used in computing net loss per share,
basic and diluted ................... 39,432,904 8,196,362 27,437,074 8,196,362
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