SAN DIEGO, Aug. 9 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company developing and commercializing products based on the extracellular matrix, today reported financial results for the three and six months ended June 30, 2007.
"We have made significant progress on the execution of our overall strategy to develop and commercialize products based on the extracellular matrix. Our three primary programs are to Enable, Improve and Innovate, leveraging our unique expertise and experience. Specifically, our Enable program focuses on HYLENEX and our Enhanze(TM) Technology for drug delivery. Our Improve program focuses on extending potential patient benefits through the co-formulation of rHuPH20 with marketed small molecules, particularly oncology and bisphosphonate drugs. And, finally, our Innovate program focuses on developing and commercializing new molecular entities targeting the extracellular matrix with emphasis on oncology and dermatology," stated Jonathan Lim, MD, Halozyme's President and CEO. "Moreover, we now have both the financial resources, as well as the management talent to move these programs forward."
Second Quarter 2007 and Subsequent Weeks' Highlights
-- The presentation of final results of the Enhanze Technology clinical
trial demonstrating improved absorption and bioavailability of
HUMIRA(R) (adalimumab), a representative commercially-available large
protein molecule therapeutic (LPMT), at the 34th Annual Meeting of the
Controlled Release Society in Long Beach, California. Enhanze
Technology is Halozyme's enzyme-based drug delivery platform based on
recombinant human PH20 hyaluronidase (rHuPH20). The presentation
included a recently completed modeled population pharmacokinetic (PK)
analysis used to estimate the effect of steady state co-administration
of rHuPH20 with the LPMT. This clinical trial, sponsored and funded
solely by Halozyme, compared the PK, safety, and tolerability of an
LPMT agent subcutaneously (SC) injected first without Enhanze
Technology (rHuPH20) and then with rHuPH20 in 15 patients.
-- The introduction by Baxter of HYLENEX recombinant (hyaluronidase human
injection) to the ophthalmology market for use in enhancing the
absorption and dispersion of other injected drugs. HYLENEX is the
first and only FDA-approved human recombinant hyaluronidase therapeutic
product and is available from Baxter in one milliliter single-dose
vials containing 150 units of hyaluronidase. Baxter also continues to
develop its INFUSE clinical program, in which HYLENEX with other fluids
or drugs are administered subcutaneously to patients. The INFUSE
trials are evaluating the potential for HYLENEX to offer an alternative
route of administration for patients with difficult venous access in
various markets.
-- The closing of a private placement of 3.5 million shares of common
stock with New River Management V, LP ("New River") at a price of $9.17
per share, for aggregate gross proceeds of approximately $32.1 million.
The per share sale price represented a $0.22 per share premium to the
closing price of Halozyme common stock on the date that the parties
executed the definitive stock purchase agreement relating to the sale
of the shares. New River is a private equity fund managed by Third
Security, LLC and affiliated with Halozyme's largest stockholder and
Board member, Randal J. Kirk.
-- The addition of Walter Bee, PhD as Vice President, Preclinical
Development. Dr. Bee will help drive the Company's pharmacology,
toxicology, PK, and pharmacodynamics. Dr. Bee was previously Director
of Toxicology, Pathology and Laboratory Animal Medicine at Johnson &
Johnson, where he was responsible for global preclinical development on
the West Coast. Dr. Bee has authored numerous scientific publications
and book chapters reflecting his experience with both small and large
molecules, across all phases of preclinical development, including
regulatory filings.
-- The addition of Randal J. Kirk and Kathryn E. Falberg to the Board of
Directors. Mr. Kirk was Founder, Chairman of the Board, President, and
CEO of New River Pharmaceuticals, Inc., which was recently sold to
Shire plc for $2.6 billion. Mr. Kirk has more than 20 years of
experience in the health care industry. Ms. Falberg is the former CFO
of Amgen and has more than 23 years of financial and management
experience. At Amgen, over a period of almost seven years, Ms. Falberg
played a key role in shaping strategy as the company grew from $1.6
billion to $4.0 billion in revenues, and from $7 billion to $70 billion
in market capitalization.
Second Quarter 2007 Financial Results
-- Net loss for the second quarter of 2007 was $4.8 million, or $0.07 per
share, compared with a net loss for the second quarter of 2006 of $3.2
million, or $0.05 per share. Net loss for the six months ended June
30, 2007 was $8.2 million, or $0.11 per share, compared with a net loss
of $6.7 million, or $0.11 per share, for the comparable period last
year.
-- Revenues for the second quarter of 2007 were $709,000, compared with
$120,000 for the second quarter of 2006. Cumulase product sales for
the second quarter of 2007 were $139,000, compared with $120,000 for
the second quarter of 2006. Revenues under collaborative agreements
were $539,000 for the three months ended June 30, 2007. Revenues under
collaborative agreements primarily consisted of the amortization of
upfront fees received from Baxter and Roche of $436,000 and research
and development reimbursements from Baxter and Roche of $103,000.
-- Research and development expenses for the second quarter of 2007 were
$4.1 million, compared with $1.9 million for the second quarter of
2006, reflecting increased compensation expenses, share-based
compensation expenses, research and development spending on Improve and
Innovate programs, and manufacturing costs associated with the
manufacturing scale up of the Company's rHuPH20 enzyme.
-- Selling, general and administrative expenses for the second quarter of
2007 were $2.4 million, compared with $1.6 million for the second
quarter of 2006, reflecting increases in compensation expenses, share-
based compensation expenses, as well as travel, facilities, and
marketing expenses compared with the prior-year quarter.
-- Cash and cash equivalents were $100.6 million as of June 30, 2007,
compared with $71.0 million as of March 31, 2007, and $44.2 million as
of December 31, 2006.
Conference Call
Halozyme management will host an investment community conference call tomorrow to discuss these topics beginning at 8:00 a.m. PDT (11:00 a.m. EDT). 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 for domestic callers, or 706- 645-9291 for international callers, and entering reservation number 10793634. The conference call will be broadcast live over the Internet at http://www.halozyme.com/ and will be available for 30 days.
About HYLENEX
HYLENEX recombinant (hyaluronidase human injection) is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs, as an adjuvant for subcutaneous fluid administration (hypodermoclysis), and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hyaluronidase is contraindicated in patients with hypersensitivity to hyaluronidase enzyme or any other ingredients in the formulation. Hyaluronidase should not be used to enhance the absorption and dispersion of dopamine and/or alpha agonist drugs. Discontinue HYLENEX recombinant if sensitization occurs. Hyaluronidase should not be applied directly to the cornea, and should not be injected around infected or acutely inflamed areas, nor used to reduce the swelling of bites or stings. Hyaluronidase should not be used for intravenous injections because the enzyme is rapidly inactivated. Furosemide, the benzodiazepines, and phenytoin are incompatible with hyaluronidase. Please see accompanying package insert for full Prescribing Information.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing products based on the extracellular matrix for the drug delivery, oncology, and dermatology markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company's Enhanz Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its first partnership is with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for 13 targets. In addition, the company has received FDA approval for two products: Cumulase(R) and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter Healthcare Corporation. The Company also has a number of different enzymes in its portfolio that are targeting significant areas of unmet need.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, (i) statements concerning the company's ability to execute on its strategy and (ii) clinical trial results and the conclusions drawn from such trials) 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-K, 10-Q, and other filings with the Securities and Exchange Commission.
HALOZYME THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - UNAUDITED
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2007 AND 2006
Three Months Ended Six Months Ended
June 30 June 30
2007 2006 2007 2006
REVENUES:
Product sales $169,082 $119,662 $356,168 $192,943
Revenue under
collaborative
agreements 539,434 - 1,162,563 -
Total Revenues 708,516 119,662 1,518,731 192,943
EXPENSES:
Cost of sales 75,518 16,538 151,746 39,498
Research and
development 4,083,885 1,914,925 6,913,249 4,106,994
Selling, general
and administrative 2,381,827 1,603,172 4,366,861 3,134,464
Total Expenses 6,541,230 3,534,635 11,431,856 7,280,956
LOSS FROM
OPERATIONS (5,832,714) (3,414,973) (9,913,125) (7,088,013)
Interest income 1,031,007 182,182 1,754,114 365,028
NET LOSS $(4,801,707) $(3,232,791) $(8,159,011) $(6,722,985)
Net loss per
share, basic and
diluted $(0.07) $(0.05) $(0.11) $(0.11)
Shares used in
computing net
loss per share,
basic and diluted 73,217,967 61,841,867 71,610,380 61,152,991
Halozyme Contact Investor Relations Contact
David A. Ramsay Don Markley
Chief Financial Officer Lippert/Heilshorn & Associates
(858) 794-8881 (310) 691-7100
dramsay@halozyme.com dmarkley@lhai.com
Halozyme Therapeutics, Inc.
