- Pipeline Update Conference Call and Webcast on May 9 at 8:00 a.m. PDT -
SAN DIEGO, May 8 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. , a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today reported financial results for the three months ended March 31, 2008.
"This year is off to a solid start as we significantly advanced both our partnered and proprietary programs in the first quarter of 2008," said Jonathan Lim, MD, Halozyme's President and CEO. "In addition, we are pleased to disclose that insulin is the target of our "Cheetah" program. We will be presenting Phase I clinical data at the upcoming American Diabetes Association meeting next month in San Francisco. This study was designed to identify whether injections of mealtime insulins formulated with PH20 could create a more rapid blood glucose control compared to the best insulin products available today indicated for diabetes. The existing global market for insulin and insulin analogs is estimated at $10 billion. A faster acting insulin may allow physicians and patients tighter glycemic control that more closely mimics natural physiologic human insulin levels and potentially result in a reduction of long-term complications."
Recent Scientific Achievements
-- Preliminary results of a Phase I/II clinical trial demonstrated that
subcutaneous infusion (under the skin) of GAMMAGARD LIQUID [Immune
Globulin Intravenous (Human)] (IGIV) with Enhanze(TM) Technology
enabled administration of a full monthly dose of immune globulin via a
single subcutaneous site to patients with primary immunodeficiency
(PID). Baxter presented the results at the annual meeting of the
American Academy of Allergy, Asthma & Immunology (AAAAI) in
Philadelphia, PA.
-- New pre-clinical findings on the treatment of prostate cancer models
at the American Association for Cancer Research conference. The
studies explored the physiologic responses to enzymatic removal of
hyaluronic acid (HA)-based matrices surrounding tumor cells in the
tumor microenvironment of prostate tumors following systemic
administration of its pegylated rHuPH20 (PEG PH20) pre-clinical
candidate. The objectives of these studies were to determine whether
HA-dependent pericellular matrices produced in vitro and in vivo by a
hormone refractory prostate cancer cell line could be enzymatically
depleted in prostate carcinoma xenografts following intravenous (IV)
administration of the PEG PH20 enzyme. In mice, IV PEG PH20 collapsed
the protective HA-based pericellular matrices of prostate cancer cells
and selectively increased tumor vascular volume 3.5-fold.
-- Findings on the local tolerability and pharmacokinetics of
bisphosphonates combined with PH20 at the American Association for
Cancer Research conference. The objectives of the presented studies
were to investigate in animal models whether increasing the dispersion
and absorption of bisphosphonates in the skin and subcutaneous tissues
with PH20 could modify injection site reaction profiles from two
intravenous bisphosphonate formulations, zoledronic acid and
ibandronate. The pharmacokinetics of bisphosphonates in blood were
also examined and compared to intravenous infusion. The maximal
concentration of bisphosphonates that could be administered without
producing injection site reactions was increased 3-to-5 fold when
co-administered in combination with PH20.
-- New safety and pharmacokinetic data from a second generation
manufacturing process for recombinant human PH20 enzyme. The data from
three studies were presented at the European Federation for
Pharmaceutical Sciences meeting for Development of Safe Protein
Therapeutics: Preclinical, Clinical and Regulatory Issues. The
presented studies investigated the IV and subcutaneous (SC) safety
assessment of PH20 administered to non-human primates at significantly
higher doses than previously examined. PH20 from a first generation
manufacturing process has been studied in a different formulation with
lower concentrations for SC injection as an adjuvant to increase
absorption and dispersion of other injected drugs and for SC fluid
administration. In a pharmacokinetic (PK) dose-range finding study,
doses up to 3,600,000 U/kg (30mg/kg) of the second generation enzyme
were well-tolerated following either IV or SC dosing.
-- Publication of the INFUSE-LR clinical trial results in the Journal of
Palliative Medicine, the official journal of the American Academy of
Palliative Medicine (Thomas JR et al. J Pall Med. December 2007;
19(6):1312-1320). The authors of this publication concluded from this
volunteer subject study that clinically relevant fluid volumes can be
rapidly delivered subcutaneously with HYLENEX in a well-tolerated
manner without the need for an infusion pump. The findings suggest
that this method of hydration could potentially replace intravenous
infusions in many clinical settings and that further studies with
HYLENEX, in patients, are warranted.
Upcoming Scientific Data Presentations
-- International Investigative Dermatology - May 14-17th - presentation
of "Temporal-Spatial Control of Tissue Contouring with an
Extracellular pH-Modulated Enzyme" pre-clinical data
-- American Diabetes Association - June 6-10th - presentation on
"Pharmacokinetics and Glucodynamics of an Insulin Analog Injected with
Recombinant Human Hyaluronidase" Phase I clinical data
-- 6th World Congress of the International Academy of Cosmetic
Dermatology - June 18-20th - podium presentation of "Temporal-Spatial
Control of Tissue Contouring with an Extracellular pH-Modulated
Enzyme" expanded pre-clinical data
First Quarter 2008 Financial Results
-- Net loss for the first quarter of 2008 was $10.0 million, or $0.13 per
share, compared with a net loss for the first quarter of 2007 of
$3.4 million, or $0.05 per share.
-- Revenues for the first quarter of 2008 were $1.8 million, compared
with $810,000 for the first quarter of 2007. Cumulase product sales
for the first quarter of 2008 were $127,000, compared with $171,000
for the first quarter of 2007. Revenues under collaborative
agreements for the first quarter of 2008 were $1.7 million, compared
with $623,000 for the first quarter of 2007. Revenues under
collaborative agreements in 2008 primarily consisted of the
amortization of upfront fees received from Baxter and Roche of
$588,000 and research and development reimbursements from Baxter of
$452,000 and Roche of $624,000.
-- Research and development expenses for the first quarter of 2008 were
$8.4 million, compared with $2.8 million for the first quarter of
2007, reflecting increased compensation expenses including share-based
compensation expenses, research and development spending on our
Insulin, Bisphosphonates, and PEG PH20 clinical and pre-clinical
programs, and production costs associated with the manufacturing
scale-up of the Company's rHuPH20 enzyme.
-- Selling, general and administrative expenses for the first quarter of
2008 were $4.2 million, compared with $2.0 million for the first
quarter of 2007, reflecting increases in compensation expenses
including share-based compensation expenses, as well as legal and
facilities expenses as compared with the prior-year quarter.
-- Cash and cash equivalents were $92.6 million as of March 31, 2008,
compared with $97.7 million as of December 31, 2007. During the
quarter the Company received a $3.5 million product-based payment for
HYLENEX.
Conference Call
Halozyme management will host a pipeline update conference call tomorrow to discuss these topics beginning at 8:00 a.m. PT (11:00 a.m. ET). To participate via telephone, please call 888-256-9044 for domestic callers, or 706-643-5585 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. The reservation number is 44830661. The conference call will be broadcast live over the Internet at http://www.halozyme.com/ and the replay will be available on the Company's website 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 at http://www.hylenex.com/ for full Prescribing Information.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the drug delivery, oncology and dermatology markets. The company's portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases. The company's Enhanze(TM) Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its key partnerships are with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets and with Baxter to apply Enhanze Technology to Baxter's biological therapeutic compound, GAMMAGARD LIQUID 10%. In addition, the company has received FDA approval for two products: Cumulase(R), for use in in-vitro fertilization, and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter International Inc. 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 potential benefits of faster acting insulin and (ii) conclusions and implications drawn from clinical and pre-clinical trial data) 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 Contact Media Contact
David A. Ramsay Karen Sparks / Joleen Schultz
Chief Financial Officer Mentus
(858) 704-8260 (858) 455-5500, x275/x215
dramsay@halozyme.com karen@mentus.com
jschultz@mentus.com
HALOZYME THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - UNAUDITED
FOR THE THREE MONTHS ENDED MARCH 31, 2008 AND 2007
Three Months Ended
March 31,
2008 2007
REVENUES:
Product sales $141,438 $187,086
Revenue under collaborative agreements 1,664,080 623,129
Total Revenues 1,805,518 810,215
OPERATING EXPENSES:
Cost of product sales 37,190 76,228
Research and development 8,444,191 2,829,364
Selling, general and administrative 4,157,603 1,985,034
Total Operating Expenses 12,638,984 4,890,626
LOSS FROM OPERATIONS (10,833,466) (4,080,411)
Interest income 879,469 723,107
NET LOSS $(9,953,997) $(3,357,304)
Basic and diluted net loss per share $(0.13) $(0.05)
Shares used in computing net loss per share,
basic and diluted 78,300,319 69,984,931
HALOZYME THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
AS OF MARCH 31, 2008 AND DECEMBER 31, 2007
March 31, December 31,
2008 2007
(unaudited)
ASSETS:
Cash and cash equivalents $92,558,408 $97,679,085
Accounts receivable 1,130,384 779,825
Inventory 679,083 703,468
Prepaid expenses and other assets 2,252,861 2,014,680
Total current assets 96,620,736 101,177,058
Property and equipment, net 2,251,099 2,283,316
Total Assets $98,871,835 $103,460,374
LIABILITIES AND STOCKHOLDERS' EQUITY:
Accounts payable $3,398,587 $3,055,637
Accrued expenses 2,942,071 2,502,259
Deferred revenue 3,261,983 3,306,225
Total current liabilities 9,602,641 8,864,121
Deferred revenue, net of current portion 38,992,374 35,963,266
Deferred rent, net of current portion 1,005,768 865,063
Stockholders' Equity:
Common stock 79,508 77,904
Additional paid-in capital 124,140,964 122,685,443
Accumulated deficit (74,949,420) (64,995,423)
Total stockholders' equity 49,271,052 57,767,924
Total Liabilities and Stockholders'
Equity $98,871,835 $103,460,374
Halozyme Therapeutics, Inc.
