Halozyme Reports First Quarter 2013 Financial Results
SAN DIEGO, May 8, 2013
SAN DIEGO, May 8, 2013 /PRNewswire/ -- Halozyme Therapeutics, Inc.(NASDAQ:
HALO) today reported financial results for the quarter ended March 31, 2013.
"With the potential for 3 new product launches over the next 12 months and
continued progress on the Hylenex^® brand, I am pleased with the steps we are
making towards our near term revenue drivers," said Gregory I. Frost, Ph.D.,
President and Chief Executive Officer, Halozyme. "Moreover, over the next 8
weeks, we will present a first-look at clinical data from our innovative
pipeline products, PEGPH20 and HTI-501."
Highlights of Halozyme's first quarter activities and recent events include:
oThe European Medicines Agency's Committee for Medicinal Products for Human
Use (CHMP) granted a positive opinion to Baxter for the use of HyQvia as
replacement therapy for adult patients with primary and secondary
oInitiated a 124 patient Phase 2 clinical study evaluating PEGPH20, a
proprietary, investigational drug, as a first-line therapy for patients
with stage IV metastatic pancreatic cancer. Patients in the study will
receive gemcitabine and nab-paclitaxel either with or without PEGPH20. The
primary endpoint will be to measure progression-free survival.
oInitiated a 400 patient Phase 4 clinical study – The CONtinuous
Subcutaneous Insulin infusion STudy ENrolling Type 1 Diabetes (CONSISTENT
1) – that will evaluate Hylenex use in conjunction with rapid analog
insulin in people with Type 1 diabetes using insulin pumps. The primary
endpoints include metabolic and safety outcomes.
oInvestigators at Yale received FDA clearance to start an artificial
pancreas investigator initiated trial that incorporates Hylenex. The
study will test the effect of Hylenex in the continuous loop setting.
oInitiated an additional multi-lot campaign with our higher productivity
manufacturing process to support potential Roche product launches.
oAppointed Matt Posard, Senior Vice President and General Manager of
Translational & Consumer Genomics at Illumina, Inc., to our Board of
First Quarter 2013 Financial Highlights
oRevenues for the first quarter of 2013 were$11.8 million, compared
to$7.4 million for the first quarter of 2012. Revenues in the first
quarter of 2013 included $9.7 million in revenue from research and
development reimbursements from partners primarily related to
manufacturing activities to support potential launches by our partners.
oResearch and development expenses for the first quarter of 2013 were$22.0
million, compared with$15.9 million for the first quarter of 2012. The
increase was due primarily to an increase in manufacturing activities to
support potential launches by our partners and an increase in clinical
oSelling, general and administrative expenses for the first quarter of 2013
were$7.6 million, compared to$6.6 million for the first quarter of 2012.
The increase was mainly due to an increase in marketing activities.
oThe net loss for the first quarter of 2013 was$19.3 million, or$0.17per
share, compared with a net loss for the first quarter of 2012 of$15.1
million, or$0.14 per share.
oCash, cash equivalents and marketable securities were$87.4 million
atMarch 31, 2013, compared with$99.5 millionatDecember 31, 2012. Net
cash used in the first quarter of 2013 was approximately$12.0 million.
Halozyme will webcast its Quarterly Update Conference Call today at 4:30 p.m.
ET/1:30 p.m. PT. Gregory I. Frost, Ph.D., Halozyme's President and Chief
Executive Officer, will lead the call. During the call, the Company plans to
provide further details underlying its first quarter 2013 financial results.
The call will be webcast through the "Investors" section of Halozyme's
corporate website at www.halozyme.com, and the recording will be made
available for 90 days following the event. To access the live webcast, please
log on to Halozyme's website approximately fifteen minutes prior to the
presentation to register and download any necessary audio software. For those
without access to the Internet, the live call may be accessed by phone by
calling (877) 407-8037 (domestic callers) or (201) 689-8037 (international
callers). A telephone replay will be available shortly after the call by
dialing (877) 660-6853 (domestic callers) or (201) 612-7415 (international
callers) using replay ID number 413625.
oBank of America Merrill Lynch 2013 Healthcare Conference, Las Vegas,
Nevada – 5/14
oUBS Global Health Care Conference, New York, NY – 5/22
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing
and commercializing innovative products that advance patient care. With a
diversified portfolio of enzymes that target the extracellular matrix, the
Company's research focuses primarily on a family of human enzymes, known as
hyaluronidases, which increase the absorption and dispersion of biologics,
drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including
diabetes, oncology and dermatology that have significant unmet medical need.
The Company markets Hylenex^® recombinant (hyaluronidase human injection) and
has partnerships with Roche, Pfizer, Baxter, ViroPharma and Intrexon. Halozyme
is headquartered in San Diego, CA. For more information on how we are
innovating, please visit our corporate website at www.halozyme.com.
Safe Harbor Statement
In addition to historical information, the statements set forth above include
forward-looking statements (including, without limitation, statements
concerning potential product launches and near-term revenue opportunities, the
Company's expected presentation of data from the PEGPH20 Phase 1b study in
pancreatic cancer and Phase 2 HTI-501 trial in cellulite, the development and
commercialization of product candidates and the potential benefits and
attributes of such product candidates) 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 typically, but
not always, 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 unexpected expenditures and costs, unexpected results or delays in
development and regulatory review, regulatory approval requirements,
unexpected adverse events and competitive conditions. These and other factors
that may result in differences are discussed in greater detail in the
Company's Annual Report on Form 10-K filed with the Securities and Exchange
Commission on March 1, 2013.
Halozyme Therapeutics, Inc.
Condensed Consolidated Statements of Operations
Three Months Ended March 31,
Product sales, net $ 1,508,594 $ 187,411
Revenues under collaborative 10,324,946 7,252,768
Total revenues 11,833,540 7,440,179
Cost of product sales 738,971 70,761
Research and development 22,034,437 15,891,109
Selling, general and 7,555,905 6,618,707
Total operating expenses 30,329,313 22,580,577
OPERATING LOSS (18,495,773) (15,140,398)
Investment and other income 54,988 21,217
Interest expense (847,584) -
NET LOSS $ (19,288,369) $ (15,119,181)
Basic and diluted net loss per share $ (0.17) $ (0.14)
Shares used in computing basic and
diluted 112,416,792 107,589,514
net loss per share
Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
March 31, December 31,
Cash and cash equivalents $ 39,017,804 $ 99,501,264
Marketable securities, available-for-sale 48,408,220 -
Accounts receivable, net 10,375,733 15,703,087
Inventories 2,737,387 2,670,696
Prepaid expenses and other assets 10,571,334 12,752,888
Total current assets 111,110,478 130,627,935
Property and equipment, net 3,975,052 3,700,462
Prepaid expenses and other assets 1,280,765 -
Restricted cash 500,000 400,000
Total Assets $ 116,866,295 $ 134,728,397
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $ 2,884,794 $ 2,271,689
Accrued expenses 9,177,574 7,783,447
Deferred revenue, current portion 6,326,158 8,891,017
Current portion of long-term debt 1,362,055 -
Total current liabilities 19,750,581 18,946,153
Deferred revenue, net of current portion 34,318,481 34,954,966
Long-term debt, net 28,323,233 29,661,680
Lease financing obligation 1,450,000 1,450,000
Deferred rent, net of current portion 906,091 861,879
Other long term liability 436,849 -
Common stock 113,143 112,709
Additional paid-in capital 349,459,065 347,314,658
Accumulated other comprehensive loss (29,131) -
Accumulated deficit (317,862,017) (298,573,648)
Total stockholders' equity 31,681,060 48,853,719
Total Liabilities and Stockholders' Equity $ 116,866,295 $ 134,728,397
Hill + Knowlton Strategies
SOURCE Halozyme Therapeutics, Inc.
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