Halozyme Reports Third Quarter 2012 Financial Results

            Halozyme Reports Third Quarter 2012 Financial Results

PR Newswire

SAN DIEGO, Nov. 8, 2012

SAN DIEGO, Nov. 8, 2012 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:
HALO) today reported financial results for the quarter ended September 30,
2012.

(Logo: http://photos.prnewswire.com/prnh/20100302/LA63139LOGO)

"We are pleased with the clinical data from the subcutaneous MabThera
(rituximab) trials which should enable filing of the marketing application in
Europe later this year," said Gregory I. Frost, Ph.D., President and Chief
Executive Officer, Halozyme. "With potential launches and near-term revenue
streams from both subcutaneous Herceptin and MabThera, we are increasing our
manufacturing activities to build launch inventory of the rHuPH20 enzyme in
support of these programs. We also continue to make progress toward growing
our own brand, Hylenex^®, by targeting the insulin pump market to complement
our late-stage partnered programs and drive sustained growth for
shareholders."

Third Quarter Highlights

Highlights of Halozyme's third quarter activities and recent events include:

  oThree Roche abstracts on the subcutaneous (SC) formulation of MabThera
    have been accepted for presentation at the American Society of Hematology
    (ASH) annual meeting in Atlanta, December 8-11.
  oAnnounced that the U.S. Food and Drug Administration (FDA) provided
    guidance enabling ViroPharma to resume clinical studies of the
    subcutaneous administration of Cinryze in combination with rHuPH20.
  oPresented data at the European Association for the Study of Diabetes from
    two treatment studies which indicate Halozyme's more physiologic insulin
    co-formulations with aspart and lispro reduced post-prandial glucose
    excursions due to the accelerated absorption and action in a Multiple
    Daily Injection (MDI) take-home setting. Both studies met their primary
    endpoint of A1C non-inferiority, and in Type 1 diabetes patients, reduced
    post-meal hypoglycemia compared to lispro alone. Results from Halozyme's
    studies in insulin pumps showed that in addition to providing a more rapid
    profile than current rapid insulin analogs, rHuPH20 also provided a more
    consistent insulin exposure and absorption over the infusion set life of
    the pump.
  oAnnounced plans to develop and commercialize Hylenex recombinant
    (hyaluronidase human injection) in insulin pumps for the U.S.
    endocrinology market.

Anticipated Milestones through 2013

  oRoche to present data from the Phase 3 MabThera SC trial and file the
    marketing authorization application (MAA) with the European Medicines
    Agency (EMA) in 2012
  oPresent HTI-501 clinical proof-of-concept data
  oDecision regarding Herceptin SC MAA from the EMA
  oComplete Cinryze SC+rHuPH20 Phase 2 study
  oInitiate Phase 4 studies to support use of Hylenex with insulin pumps
  oPresent data fromthe run-incohorts of the PEGPH20 Phase 2 program in
    oncology and continue with the randomized portion of the trial

Third Quarter 2012 and Year-To-Date Financial Results

The net loss for the third quarter of 2012 was $(20.0) million, or $(0.18) per
share, compared with a net income for the third quarter of 2011 of $5.2
million, or $0.05 per share. The net loss for the nine months ended September
30, 2012 was $(49.1) million, or $(0.44) per share, compared to a net loss of
$(1.4) million, or $(0.01) per share, for the comparable period in 2011.

  oRevenues for the third quarter of 2012 were $5.3 million, compared to
    $22.9 million for the third quarter of 2011. Revenues in the third quarter
    of 2012 primarily consisted of research and development reimbursements
    from partners.
  oResearch and development expenses for the third quarter of 2012 were $19.5
    million, compared with $13.5 million for the third quarter of 2011,
    primarily due to an increase in manufacturing activities to support
    potential launches from our partners.
  oSelling, general and administrative (SG&A) expenses for the third quarter
    of 2012 were $5.6 million, compared to $4.3 million for the third quarter
    of 2011. The increase for SG&A was due to higher compensation costs during
    the quarter.
  oCash and cash equivalents were $87.6 million as of September 30, 2012,
    compared with $66.3 million as of September 30, 2011. Net cash used in the
    third quarter of 2012 was approximately $14.4 million.
  o2012 cash burn guidance remains at $60-$65 million.

Conference Call

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 third quarter 2012 financial results.
The call will be webcast live through the "Investors" section of Halozyme's
corporate website and a recording will be made available following the close
of the call. To access the webcast, please log on to www.halozyme.com
approximately 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 402796.

About Hylenex^® recombinant (hyaluronidase human injection)

Hylenex recombinant is a tissue permeability modifier approved for use by the
U.S. Food and Drug Administration. Hylenex recombinant temporarily breaks down
a gel-like substance (hyaluronan) that forms a barrier in the tissues between
cells under the skin making the tissue more permeable and facilitating the
absorption of fluids/medicines into systemic circulation. Hylenex recombinant
is indicated as an adjuvant to increase the absorption and dispersion of other
injected or subcutaneously infused drugs, to facilitate subcutaneous fluid
administration and in subcutaneous urography.Hylenex recombinant is
contraindicated in patients with a known hypersensitivity to hyaluronidase or
any excipient used to make the drug. For additional information or full
Prescribing Information visit www.hylenex.com or www.halozyme.com.

About Halozyme

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, that increase the absorption and dispersion of biologics,
drugs and fluids. Halozyme's pipeline addresses therapeutic areas, such as
diabetes, oncology and dermatology that have significant unmet medical need.
The Company markets Hylenex^® recombinant (hyaluronidase human injection) and
has partnerships with Roche, 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 ours and our collaborators' programs in development, the benefits,
attributes and commercial opportunity of pre-administration of Hylenex
recombinant with insulin pumps, our intention to launch Hylenex recombinant
for such market, the anticipated approval and launch of the subcutaneous
Herceptin and MabThera product candidates and possible revenues that may be
generated therefrom, the events listed under the heading "Anticipated
Milestones through 2013," and our anticipated cash burn for 2012. These
statements 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,
clinical trial results, 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 the Securities and Exchange Commission.

Halozyme Therapeutics, Inc
Unaudited Condensed Consolidated Statements of Operations
                        Three Months Ended          Nine Months Ended
                        September 30,              September 30,
                        2012          2011          2012          2011
REVENUES:
  Product sales, net    $          $ 1,156,903  $            $ 1,487,822
                        715,354                     1,427,707
  Revenues under
  collaborative         4,618,969     21,785,525    19,103,970    52,187,447
  agreements
        Total revenues  5,334,323     22,942,428    20,531,677    53,675,269
OPERATING EXPENSES:
  Cost of product sales 226,635       11,723        440,516       201,675
  Research and          19,503,491    13,514,352    51,476,329    42,647,265
  development
  Selling, general and  5,634,034     4,263,520     17,833,165    12,237,152
  administrative
        Total operating 25,364,160    17,789,595    69,750,010    55,086,092
        expenses
OPERATING INCOME (LOSS) (20,029,837)  5,152,833     (49,218,333)  (1,410,823)
Interest and other      23,991        12,360        72,187        56,586
income, net
NET INCOME (LOSS)       $             $ 5,165,193  $             $
                        (20,005,846)                (49,146,146)  (1,354,237)
Basic and diluted net   $        $        $        $    
income (loss) per share (0.18)       0.05          (0.44)       (0.01)
Shares used in
computing net income
(loss)
 per share:
  Basic                 112,305,002   103,223,352   110,658,757   102,282,904
  Diluted               112,305,002   105,009,189   110,658,757   102,282,904

Halozyme Therapeutics, Inc
Unaudited Condensed Consolidated Balance Sheets
                                            September 30,     December 31,
                                            2012               2011
ASSETS
Current assets:
      Cash and cash equivalents             $   87,614,891   $  52,825,527
      Accounts receivable, net              4,464,273          2,262,465
      Inventories                           2,186,063          567,263
      Prepaid expenses and other assets     11,353,342         8,332,242
           Total current assets             105,618,569        63,987,497
Property and equipment, net                 2,363,650          1,771,048
           Total Assets                     $  107,982,219    $  65,758,545
LIABILITIES AND STOCKHOLDERS'
EQUITY
Current liabilities:
      Accounts payable                     $    3,526,839  $   7,556,859
      Accrued expenses                      8,041,673          5,615,574
      Deferred revenue, current portion     9,470,247          4,129,407
           Total current liabilities        21,038,759         17,301,840
Deferred revenue, net of current portion    34,883,135         36,754,583
Deferred rent, net of current portion       870,548            802,006
Stockholders' equity:
      Common stock                          112,693            103,990
      Additional paid-in capital            345,244,876        255,817,772
      Accumulated deficit                   (294,167,792)      (245,021,646)
           Total stockholders' equity       51,189,777         10,900,116
           Total Liabilities and            $  107,982,219    $  65,758,545
           Stockholders' Equity

Media/Investor Contact:
Anne Erickson
Executive Director
Halozyme Therapeutics
858-704-8264
aerickson@halozyme.com

SOURCE Halozyme Therapeutics, Inc.

Website: http://www.halozyme.com
 
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