Halozyme Reports Fourth Quarter and Year End 2012 Financial Results
SAN DIEGO, Feb. 25, 2013
SAN DIEGO, Feb. 25, 2013 /PRNewswire/ --Halozyme Therapeutics, Inc.(NASDAQ:
HALO) today reported financial results for the fourth quarter and year
endedDecember 31, 2012.
"2012 was another productive year marked by key partner regulatory filings in
Europe, as well as our establishment of a new collaboration with Pfizer,"
saidGregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme.
"These advancements, coupled with the continued progress of our own pipeline
products, leave Halozyme well-positioned for continued growth in 2013."
Fourth Quarter Highlights
Highlights of Halozyme's fourth quarter and recent activities include:
oPfizer Collaboration: Entry into a worldwide Collaboration and License
Agreement with Pfizer Inc. for the purpose of developing and
commercializing products combining proprietary Pfizer biologics with
Halozyme's Enhanze™ Technology. Pfizer has elected three exclusive
licenses to therapeutic targets in primary care and specialty care
indications, and has the right to elect up to three additional targets
upon payment of additional fees.
oCinryze^® Phase 2 Trial: ViroPharma initiated a Phase 2b study to evaluate
the safety and efficacy of subcutaneous (SC) administration of Cinryze (C1
esterase inhibitor [human]) in adolescents and adults with hereditary
angioedema (HAE) for prevention of HAE attacks.
oMabThera^® EMA Filing: Roche submitted a line extension application to the
European Medicines Agency (EMA) for a subcutaneous (SC) formulation of
MabThera (rituxumab). MabThera SC uses Halozyme's Enhanze Technology,
which enables the injection of large volumes of a medication under the
skin and may result in faster administration times versus intravenously
(IV) administered MabThera.
oMabThera Positive Trials: Announced positive results from Roche's SABRINA
and SparkThera studies, which showed that a fixed dose of MabThera can be
administered subcutaneously, potentially allowing patients to spend less
time in infusion centers receiving their MabThera treatment. Specifically,
the studies showed that subcutaneous injection resulted in non-inferior
MabThera concentrations in the blood compared with standard IV infusion.
Fourth Quarter and Year End 2012 Financial Results
The net loss for the fourth quarter of 2012 was$4.4 million, or$0.04per
share, compared with a net loss for the fourth quarter of 2011 of$18.4
million, or$0.18 per share. The net loss for the year endedDecember 31,
2012was$53.6 million, or$0.48 per share, compared to a net loss of$19.8
million, or$0.19 per share for the comparable period in 2011.
oRevenues for the fourth quarter of 2012 were$21.8 million, compared
to$2.4 million for the fourth quarter of 2011. Revenues in the fourth
quarter of 2012 included license fees revenue from Pfizer of $9.5 million
and a milestone payment from Rocheof $4 million.
oResearch and development expenses for the fourth quarter of 2012
were$18.6 million, compared with$14.9 million for the fourth quarter of
2011. The increase was due primarily to an increase in manufacturing
activities to support potential launches from our collaborators.
oSelling, general and administrative expenses for the fourth quarter of
2012 were$7.0 million, compared to$5.9 million for the fourth quarter of
oCash and cash equivalents were$99.9 million as ofDecember 31, 2012,
which includes net proceeds of $29.7 million from a term loan with Oxford
Finance and Silicon Valley Bank for working capital and other near-term
growth initiatives, compared with$52.8 millionas ofDecember 31, 2011.
Excluding the proceeds from the term loan, net cash used in the fourth
quarter of 2012 was approximately$17.4 million.
Financial guidance for 2013 was announced on January 7, 2013 and remains
unchanged, with an expected net cash burn to be between $45 and $50 million.
Halozyme will webcast its Quarterly Update and Year End 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 fourth quarter and full year
end 2012 financial results. To access the webcast, please log on
towww.halozyme.comapproximately fifteen minutes prior to the call to
register, download, and install 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 409638.
Upcoming Corporate Presentation
Halozyme is scheduled to present at the upcoming Barclays Global Healthcare
Conference in Miami on March 12, 2013 at 4:15 p.m. ET/1:15 p.m. PT.
The presentation will be webcast through the "Investors" section of Halozyme's
corporate website atwww.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.
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 the Company's expected net cash burn for 2013, the development and
commercialization of products and the potential benefits and attributes of
such products) 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 unexpected expenditures
and costs, unexpected results or delays in development and regulatory review,
regulatory approval requirements, unexpected adverse event 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 theSecurities and Exchange Commission.
Halozyme Therapeutics, Inc.
Unaudited Condensed Consolidated Statements of Operations
Three Months Ended Twelve Months Ended
December 31, December 31,
2012 2011 2012 2011
Product sales, net $ $ $ $
1,459,735 348,280 2,887,442 1,836,102
collaborative 20,333,814 2,062,886 39,437,784 54,250,334
Total revenues 21,793,549 2,411,166 42,325,226 56,086,436
Cost of product sales 653,884 56,159 1,094,400 257,834
Research and 18,567,744 14,916,205 70,044,073 57,563,470
Selling, general and 6,979,034 5,866,921 24,812,199 18,104,073
Total operating 26,200,662 20,839,285 95,950,672 75,925,377
OPERATING LOSS (4,407,113) (18,428,119) (53,625,446) (19,838,941)
Interest and other 1,257 12,504 73,444 69,090
NET LOSS $ $ $ $
(4,405,856) (18,415,615) (53,552,002) (19,769,851)
Basic and diluted net $ $ $ $
loss per share (0.04) (0.18) (0.48) (0.19)
Shares used in computing
basic and diluted
net loss per share 112,323,056 103,406,407 111,077,105 102,566,089
Halozyme Therapeutics, Inc.
Unaudited Condensed Consolidated Balance Sheets
December 31, December 31,
Cash and cash equivalents $ 99,901,264 $ 52,825,527
Accounts receivable, net 15,703,087 2,262,465
Inventories 2,670,696 567,263
Prepaid expenses and other assets 12,752,888 8,332,242
Total current assets 131,027,935 63,987,497
Property and equipment, net 3,700,462 1,771,048
Total Assets $ 134,728,397 $ 65,758,545
LIABILITIES AND STOCKHOLDERS'
Accounts payable $ 2,271,689 $ 7,556,859
Accrued expenses 7,783,447 5,615,574
Deferred revenue, current portion 8,891,017 4,129,407
Total current liabilities 18,946,153 17,301,840
Deferred revenue, net of current portion 34,954,966 36,754,583
Long-term debt, net 29,661,680 -
Lease financing obligation 1,450,000 -
Deferred rent, net of current portion 861,879 802,006
Common stock 112,709 103,990
Additional paid-in capital 347,314,658 255,817,772
Accumulated deficit (298,573,648) (245,021,646)
Total stockholders' equity 48,853,719 10,900,116
Total Liabilities and Stockholders' $ 134,728,397 $ 65,758,545
Hill + Knowlton Strategies
SOURCE Halozyme Therapeutics, Inc.
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