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Halozyme Therapeutics Reports 2008 First Quarter Financial Results

- Pipeline Update Conference Call and Webcast on May 9 at 8:00 a.m. PDT -

SAN DIEGO, May 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 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


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 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 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




Three Months Ended

March 31,

2008 2007


Product sales $141,438 $187,086

Revenue under collaborative agreements 1,664,080 623,129

Total Revenues 1,805,518 810,215


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



AS OF MARCH 31, 2008 AND DECEMBER 31, 2007

March 31, December 31,

2008 2007



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


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

SOURCE Halozyme Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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