Halozyme Therapeutics Reports Second Quarter 2009 Financial Results

Posted on: Fri, 07 Aug 2009 07:29:00 EDT


Symbols: HALO, HTI
SAN DIEGO, Aug 07, 2009 (BUSINESS WIRE) --
HTI | Quote | Chart | News | PowerRating -- Halozyme Therapeutics, Inc. (Nasdaq: HALO | Quote | Chart | News | PowerRating), a biopharmaceutical company
developing and commercializing products targeting the extracellular
matrix for the endocrinology, oncology, dermatology and drug delivery
markets, today reported financial results for the three and six months
ended June 30, 2009.

"Halozyme continues to advance on multiple fronts including the
presentation of encouraging Insulin-PH20 data at the ADA meeting, the
selection of a fifth exclusive target by Roche, and the completion of
patient enrollment in our first type 1 Insulin-PH20 treatment study with
three times per day dosing," said Jonathan Lim, M.D., Halozyme's
President and CEO. "I am also pleased we have recruited Mike Shepard,
Ph.D. and Jonathan Leff, M.D., two highly successful biotech industry
leaders who will help take Halozyme's research and development
capabilities to a new level of excellence."

Second Quarter 2009 and Recent Corporate Developments and Scientific
Achievements

--
Halozyme raised net proceeds of $38.2 million through a public
offering of 6,150,000 newly issued shares of common stock priced at
$6.50 per share. The offering closed on June 26, 2009 and resulted in
a cash balance of $89.2 million as of June 30, 2009. Excluding the
proceeds from the financing, we still expect 2009 net cash burn to be
between $30 and $35 million. Including the proceeds of the financing,
the company expects a net cash increase of $5 to $10 million.

--
Results from a Phase 2 clinical trial in type 1 diabetic patients
comparing Humalog(R) (insulin lispro) with and without
rHuPH20 demonstrated faster insulin absorption and increased peak
insulin concentrations for the insulin-enzyme combination. The study
also showed a significant reduction in postprandial blood glucose
levels following administration of a standardized test meal. Mean
glucose levels after the meal challenge remained within current
treatment targets throughout the eight hour post meal observation
period. Halozyme presented these results at the American Diabetes
Association meeting on June 6, 2009 in New Orleans. Additional results
from the study for Humulin(R) R (regular human insulin) with
and without rHuPH20 will be presented at the European Association for
the Study of Diabetes (EASD) annual meeting in Vienna on September 30,
2009. Additional studies to determine the optimal insulin and rHuPH20
enzyme dose and concentration and intra-subject variability are
underway. A Phase 2, three times per day, multi-dose, crossover study
comparing regular insulin plus rHuPH20 to Humalog alone has completed
patient enrollment. A Phase 2 standard meal study in type 2 diabetic
patients began in July and will compare insulin lispro+PH20 and
regular insulin+PH20 to lispro (Humalog) alone. Our goal is to develop
a best in class insulin product in comparison to the current gold
standard analog products on the market today.

--
In June 2009, Roche selected a fifth exclusive target under our
existing license and collaboration agreement. Roche paid Halozyme
$4.25 million, net of previously paid maintenance fees, for exclusive,
global rights for the application of Halozyme's hyaluronidase enzyme,
rHuPH20, to a fifth biologic target.

--
Patient enrollment has been completed in the Phase 3 pivotal study of
GAMMAGARD LIQUID with rHuPH20 for the treatment of primary
immunodeficiency disorder. Patients will receive monthly subcutaneous
injections of Halozyme's rHuPH20 with Baxter's GAMMAGARD LIQUID.

--
H. Michael Shepard, Ph.D., joined Halozyme in June 2009 as vice
president of discovery research. Previously at Genentech, Dr. Shepard
led the team that discovered the breast cancer drug Herceptin(TM)
(trastuzumab). In July 2009, Jonathan Leff, M.D. was appointed vice
president and chief medical officer. Dr. Leff, previously the global
head of inflammation clinical development at Roche, brings extensive
experience in pharmaceutical product development from early stage
molecules through post marketing clinical investigations.

Second Quarter 2009 Financial Results

The net loss for the second quarter of 2009 was $17.1 million, or $0.21
per share, compared with a net loss for the second quarter of 2008 of
$11.0 million, or $0.14 per share. Net loss for the six months ended
June 30, 2009 was $31.8 million, or $0.38 per share, compared with a net
loss of $21.0 million, or $0.27 per share for the comparable period last
year.

--
Revenue for the second quarter of 2009 was $1.4 million, which equaled
$1.4 million for the second quarter of 2008. Revenues under
collaborative agreements for the second quarter of 2009 were $1.2
million, compared to $1.4 million for the second quarter of 2008.
Revenues under collaborative agreements in the second quarter of 2009
primarily consisted of the amortization of license fees and milestone
payments received from Baxter and Roche of $0.7 million and research
and development reimbursements from Baxter and Roche of $0.5 million.

--
Research and development expenses for the second quarter of 2009 were
$14.6 million, compared to $8.9 million for the second quarter of
2008, primarily due to an increase in clinical trial expenses and
outsourced research and development expense due to spending on the
PEGPH20 and Insulin-PH20 programs, an increase in research and
development headcount, and production costs associated with the
manufacturing scale-up of the rHuPH20 and PEGPH20 enzymes.

--
Selling, general and administrative expenses for the second quarter of
2009 were $3.9 million, compared to $3.8 million for the second
quarter of 2008.

--
Cash and cash equivalents totaled $89.2 million as of June 30, 2009,
compared with $63.7 million as of December 31, 2008 and $82.4 million
as of June 30, 2008. During the second quarter of 2009 the company
received cash of $4.25 million from Roche and $38.2 million of net
proceeds from an equity financing. Net cash burn for the second
quarter of 2009, not including the equity financing, was $10.9 million.

Upcoming Corporate and Scientific Presentations

Halozyme representatives are scheduled to present at the following
meetings and conferences:

-- Southern California Investor Conference to be held in Newport Beach,
Calif. on August 18, 2009

-- UBS Global Life Sciences Conference to be held in New York on
September 21-23, 2009

-- European Association for the Study of Diabetes 45th Annual
Meeting in Vienna, Austria on September 30, 2009

-- Investor R&D Day, hosted by Halozyme management, to be held in New
York on October 15, 2009.

Conference Call

Halozyme management will host a conference call and webcast on August 7,
2009 to discuss these topics beginning at 8:00 a.m. PST (11:00 a.m.
EST). To participate via telephone, please call 888-256-9044 for
domestic callers or 706-643-5585 for international callers. The
conference ID # is 22806199. A telephone replay will be available
beginning approximately two hours after the call by dialing 800-642-1687
for domestic callers or 706-645-9291 for international callers. The
conference call will be broadcast live over the Internet at www.halozyme.com
and the replay will be available on the company's Web site for seven
days.

About Halozyme Therapeutics, Inc.

Halozyme is a biopharmaceutical company developing and commercializing
products targeting the extracellular matrix for the endocrinology,
oncology, dermatology and drug delivery markets. The company's portfolio
of products and product candidates is based on intellectual property
covering the family of human enzymes known as hyaluronidases and
additional enzymes that affect the extracellular matrix. Halozyme's
Enhanze(TM) Technology is a novel drug delivery platform
designed to increase the dispersion and absorption of biologics. The
company has key partnerships with Roche to apply Enhanze Technology to
Roche's biological therapeutics for up to 13 targets and with Baxter
BioScience to apply Enhanze Technology to Baxter's biological
therapeutic compound, GAMMAGARD LIQUID(TM). The product
candidates in Halozyme's research pipeline target multiple areas of
significant unmet medical need. For more information visit www.halozyme.com.

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 financial position 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
Quarters Ended June 30, Six Months Ended June 30,
2009 2008 2009 2008
(unaudited) (unaudited) (unaudited) (unaudited)
REVENUES:
Revenues under collaboration agreements $ 1,246,205 $ 1,351,492 $ 3,940,369 $ 3,015,572
Product sales 179,951 82,727 258,158 224,165
Total revenues 1,426,156 1,434,219 4,198,527 3,239,737
OPERATING EXPENSES:
Cost of product sales 45,097 37,126 49,301 74,316
Research and development 14,561,137 8,925,488 28,601,224 17,369,679
Selling, general and administrative 3,903,642 3,846,175 7,390,464 8,003,778
Total operating expenses 18,509,876 12,808,789 36,040,989 25,447,773
OPERATING LOSS (17,083,720 ) (11,374,570 ) (31,842,462 ) (22,208,036 )
Interest income 23,695 372,180 57,073 1,251,649
NET LOSS $ (17,060,025 ) $ (11,002,390 ) $ (31,785,389 ) $ (20,956,387 )
Basic and diluted net loss per share $ (0.21 ) $ (0.14 ) $ (0.38 ) $ (0.27 )
Shares used in computing basic and diluted net loss per share
82,990,107 79,454,496 82,807,253 78,923,520

Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
June 30 December 31,
2009 2008
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 89,240,763 $ 63,715,906
Accounts receivable 893,093 7,264,410
Inventory 803,534 441,323
Prepaid expenses and other assets 2,711,585 2,591,149
Total current assets 93,648,975 74,012,788
Property and equipment, net 2,646,666 2,549,925
Total Assets $ 96,295,641 $ 76,562,713
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 5,430,644 $ 6,668,791
Accrued expenses 4,721,593 3,995,897
Deferred revenue 5,016,178 3,553,730
Total current liabilities 15,168,415 14,218,418
Deferred revenue, net of current portion 53,667,269 45,894,726
Deferred rent, net of current portion 1,025,399 1,069,573
Stockholders' equity:
Common stock 89,657 81,554
Additional paid-in capital 171,779,912 128,948,064
Accumulated deficit (145,435,011 ) (113,649,622 )
Total stockholders' equity 26,434,558 15,379,996
Total Liabilities and Stockholders' Equity $ 96,295,641 $ 76,562,713

SOURCE: Halozyme Therapeutics, Inc.


Halozyme
Robert H. Uhl
Senior Director, Investor Relations
858-704-8264
ruhl@halozyme.com

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