SAN DIEGO, Aug. 8 /PRNewswire-FirstCall/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix, today reported financial results for the three and six months ended June 30, 2008.
"As we've previously stated, we continue to increase our focus and
resources on our proprietary programs that target large markets. Now we are
beginning to see tangible results of that effort. Data from recent
presentations at medical conferences validates the strength of our
technology platform across multiple therapeutic areas," said Jonathan Lim,
MD, President and CEO of Halozyme. "For example, Phase I clinical results
showed faster absorption and onset for insulin when co-administered with
our PH20 enzyme, a profile more similar to the body's own natural insulin.
This could lead to the development of a best-in-class product. We have also
demonstrated in animal models significant tumor suppression for PEGPH20
plus chemotherapy and controlled degradation of a structural component of
the skin with HTI-501 that may prove beneficial in various dermatologic
conditions. Over the next six months, we plan to initiate additional
clinical trials to enhance the value of our pipeline."
Recent Scientific Achievements
-- Presentation of Phase I clinical results from the Company's diabetes
mellitus program at the American Diabetes Association's 68th Scientific
Sessions. The data showed that combining the Company's proprietary
recombinant human hyaluronidase enzyme (rHuPH20) with Humulin R(R)
(regular insulin human) or Humalog(R) (insulin lispro) yielded
pharmacokinetics and glucodynamics that better mimicked physiologic
prandial (mealtime) insulin release and activity than Humulin R or
Humalog alone. Statistically significant pharmacokinetic (PK) and
glucodynamic (GD) improvements observed in the study include:
Significantly faster systemic absorption of each insulin starting with
the first observation time point of three minutes after injection,
faster and greater glucose lowering activity early after injection,
greater peak insulin levels for the same dose administered, lower
variability of key PK and GD variables across subjects, and improvement
for rHuPH20 in combination with Humulin across all parameters when
compared to Humalog alone.
-- Release of Chemophase(R) Phase I/IIa clinical results from a continuing
clinical trial in the treatment of superficial bladder cancer. Based
on the results, the Chemophase combination treatment of mitomycin plus
the rHuPH20 enzyme was well tolerated and appears safe. The study
reported no dose-limiting toxicities and no observed side effects
attributable to the enzyme, and established the dose for subsequent
clinical trials, therefore achieving the pre-defined primary objective
of the study. In addition, there were no neutralizing antibodies to
rHuPH20 detected and the plasma concentration of mitomycin was either
non-measureable or negligible and well below the threshold that may be
predictive for myelosuppression (a decrease in bone marrow activity,
resulting in fewer red blood cells, white blood cells, and platelets).
-- New findings of positive pre-clinical animal efficacy data for
pegylated-rHuPH20 enzyme (PEGPH20) at the American Association for
Cancer Research (AACR) Translational Cancer Medicine meeting in
Monterey, CA. The study showed that treatment of hormone resistant
human prostate cancer in tumor bearing mouse models with intravenous
PEGPH20 in combination with the chemotherapeutic drugs, docetaxel
(Taxotere(R)) or liposomal doxorubicin (Doxil(R)) resulted in a
substantial increase in anti-tumor activity. The docetaxel combination
treatment demonstrated significantly enhanced survival compared to
treatment with the chemotherapeutic agent alone. The effects of PEGPH20
were selective to prostate tumors producing hyaluronan, consistent with
the selective reduction of tumor interstitial fluid pressure. Treatment
with PEGPH20 was well tolerated without significant increases in
neutropenia (depletion of neutrophils, a type of white blood cell)
compared to chemotherapy alone.
-- New pre-clinical findings on the controlled modification of the
extracellular matrix with HTI-501 at the European Society for
Dermatological Research and Japanese Society for Investigative
Dermatology. HTI-501, a new recombinant human lysosomal proteinase
that could provide an effective dermatologic treatment by targeting and
degrading the fibrous components of the extracellular matrix in a
highly controlled fashion. This new molecular entity is being explored
as a potential solution for medical, as well as aesthetic, dermatology
indications for which surgery may be impractical, such as cellulite and
certain forms of scarring. HTI-501 works by a process called enzymatic
subscision, which involves degradation of fibrous septae (or cords) in
a controllable and predictable manner to release skin tissue from the
fibrous cords and smooth out the surface contour. It could be
especially beneficial in aesthetic dermatology indications.
Second Quarter 2008 Financial Results
-- Net loss for the second quarter of 2008 was $11.0 million, or $0.14 per
share, compared with a net loss for the second quarter of 2007 of $4.8
million, or $0.07 per share. Net loss for the six months ended June
30, 2008 was $21.0 million, or $0.27 per share, compared with a net
loss of $8.2 million, or $0.11 per share, for the comparable period
-- Revenues for the second quarter of 2008 were $1.4 million, compared
with $709,000 for the second quarter of 2007. Revenues under
collaborative agreements for the second quarter of 2008 were $1.4
million, compared with $539,000 for the second 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
$554,000 and Roche of $210,000. Cumulase(R) product sales for the
second quarter of 2008 were $48,000, compared with $139,000 for the
second quarter of 2007.
-- Research and development expenses for the second quarter of 2008 were
$8.9 million, compared with $4.1 million for the second quarter of
2007, reflecting increased compensation expenses including share-based
compensation expenses, research and development spending on the
Company's 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 second quarter of
2008 were $3.8 million, compared with $2.4 million for the second
quarter of 2007, reflecting increases in compensation expenses
including share-based compensation expenses, as well as higher legal
and facilities expenses compared with the prior-year quarter.
-- Cash and cash equivalents were $82.4 million as of June 30, 2008,
compared with $97.7 million as of December 31, 2007.
Halozyme management will host a pipeline update conference call today 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.
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, metabolism, 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,
statements relating to an insulin product and 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
Robert H. Uhl Karen Sparks / Joleen Schultz
Senior Director, Investor Relations Mentus
(858) 704-8264 (858) 455-5500, x275/x215
HALOZYME THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - UNAUDITED
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2008 AND 2007
Three Months Ended Six Months Ended
June 30, June 30,
2008 2007 2008 2007
agreements $1,351,492 $539,434 $3,015,572 $1,162,563
Product sales 82,727 169,082 224,165 356,168
Total Revenues 1,434,219 708,516 3,239,737 1,518,731
Cost of product
sales 37,126 75,518 74,316 151,746
development 8,925,488 4,083,885 17,369,679 6,913,249
administrative 3,846,175 2,381,827 8,003,778 4,366,861
Expenses 12,808,789 6,541,230 25,447,773 11,431,856
OPERATIONS (11,374,570) (5,832,714) (22,208,036) (9,913,125)
Interest income 372,180 1,031,007 1,251,649 1,754,114
NET LOSS $(11,002,390) $(4,801,707) $(20,956,387) $(8,159,011)
Basic and diluted
net loss per share $(0.14) $(0.07) $(0.27) $(0.11)
Shares used in
loss per share,
diluted 79,454,496 73,217,967 78,923,520 71,610,380
HALOZYME THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
AS OF JUNE 30, 2008 AND DECEMBER 31, 2007
June 30, December 31,
Cash and cash equivalents $82,410,139 $97,679,085
Accounts receivable 1,160,990 779,825
Inventory 649,254 703,468
Prepaid expenses and other assets 1,895,820 2,014,680
Total current assets 86,116,203 101,177,058
Property and equipment, net 2,439,765 2,283,316
Total Assets $88,555,968 $103,460,374
LIABILITIES AND STOCKHOLDERS' EQUITY:
Accounts payable $2,814,512 $3,055,637
Accrued expenses 3,338,896 2,502,259
Deferred revenue 3,255,461 3,306,225
Total current liabilities 9,408,869 8,864,121
Deferred revenue, net of current portion 38,376,170 35,963,266
Deferred rent, net of current portion 1,116,892 865,063
Common stock 80,099 77,904
Additional paid-in capital 125,525,748 122,685,443
Accumulated deficit (85,951,810) (64,995,423)
Total stockholders' equity 39,654,037 57,767,924
Total Liabilities and
Stockholders' Equity $88,555,968 $103,460,374
|SOURCE Halozyme Therapeutics, Inc.|
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