SAN DIEGO, Feb. 29, 2016 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the fourth quarter and full year ended December 31, 2015, which included a fourth quarter increase in royalty revenue of 136 percent from the prior year period and net income of $4.3 million, or $0.03 per share, compared to a net loss in the fourth quarter of 2014 of $5.3 million, or $0.04 per share. For the full year, total revenue increased 79 percent to $135.1 million compared to $75.3 million in the prior year.

"We closed 2015 with record progress across both pillars of our strategy and enter 2016 with strong momentum," said Dr. Helen Torley, president and chief executive officer. "In our oncology pillar, an investigational device exemption was submitted to the FDA earlier this month by our partner Ventana for the PEGPH20 companion diagnostic test. We remain on track to dose the first patient in March in our Phase 3 study in pancreatic cancer patients. We are also continuing to evaluate the dose of PEGPH20 in our lung and gastric cancer trials and are preparing for the initiation of the breast cancer trial with our clinical partner Eisai.

"At the same time, our ENHANZE(TM) platform continues to generate more value than any other time in company history. With royalty revenue growth in the fourth quarter, a newly signed licensing and collaboration agreement with Eli Lilly and four co-formulated products in the clinic, our ENHANZE platform remains a clear differentiator in any market environment."

Fourth Quarter 2015 Highlights and Subsequent Events include:


    --  Submitting an investigational device exemption to the FDA for the
        companion diagnostic test developed with Ventana to prospectively
        identify patients with high levels of hyaluronan, or HA.
    --  Remaining on track to dose first patient in HALO-301 | Pancreatic study
        in March 2016, a Phase 3 study to explore PEGPH20 with gemcitabine and
        ABRAXANE(®) (nab-paclitaxel) in metastatic pancreatic cancer patients
        at approximately 200 sites in 20 countries located in North America,
        Europe, South America and Asia Pacific.
    --  Closing enrollment in HALO-202 | Pancreatic study with 133 patients in
        Stage 2 (total 279 patients enrolled), the company remains blinded to
        the efficacy results and continues to project mature progression-free
        survival data and overall response rate data in the fourth quarter of
        2016.
    --  Continuing to explore the pan-tumor potential of PEGPH20, the company
        made progress towards identifying the maximum tolerated dose of PEGPH20
        in its phase 1b/2 PRIMAL study of PEGPH20 plus docetaxel in lung cancer
        patients, and Phase 1b study of PEGPH20 plus KEYTRUDA(®)
        (pembrolizumab) in lung and gastric cancer patients. In addition,
        Halozyme expects to initiate the study of PEGPH20 plus eribulin in HER2
        negative breast cancer patients through a clinical collaboration with
        Eisai in the second quarter of 2016.
    --  Signing the company's sixth collaboration and licensing agreement for
        Halozyme's proprietary ENHANZE((TM)) technology platform with Eli Lilly
        for up to five targets, each with potential milestone payments of $160
        million. The agreement resulted in a $25 million upfront license fee to
        Halozyme that was recorded in the fourth quarter.
    --  Earlier this month, dosing the first subject in Pfizer's Phase 1
        clinical trial evaluating the safety, tolerability and pharmacokinetics
        of bococizumab, an investigational PCSK9 inhibitor developed by Pfizer,
        Inc. using Halozyme's ENHANZE((TM)) platform. The initiation of the
        clinical trial triggered a $1 million milestone payment to Halozyme
        under the collaboration and license agreement between Halozyme and
        Pfizer entered into in 2012.
    --  In January, dosing the first subject in AbbVie's Phase 1 clinical trial
        evaluating the safety and pharmacokinetics of adalimumab (HUMIRA(®))
        with Halozyme's ENHANZE((TM) )platform, resulting in a $5 million
        milestone payment under the collaboration and license agreement between
        Halozyme and AbbVie entered into in June of 2015.
    --  In the fourth quarter, dosing the first subjects in Pfizer's Phase 1
        clinical trial of rivipansel and Janssen's Phase 1b clinical trial of
        daratumumab with Halozyme's ENHANZE(TM) platform.

Fourth Quarter and Full Year 2015 Financial Highlights


    --  Revenue for the fourth quarter was $52.2 million, compared to $30.4
        million for the fourth quarter of 2014, driven primarily by the upfront
        license fee from Eli Lilly and royalties from partner sales of
        Herceptin(®) SC, MabThera(®) SC and HyQvia(®).  Revenue for the
        quarter included $9.5 million in royalties, $9.3 million in sales of
        bulk rHuPH20 for use in manufacturing collaboration products and $4.3
        million in HYLENEX(®) recombinant (hyaluronidase human injection)
        product sales.  Revenue for the full year was $135.1 million compared to
        $75.3 million in the previous year.
    --  Research and development expenses for the fourth quarter were $27.7
        million, compared to $19.7 million for the fourth quarter of 2014. The
        planned increases were primarily due to expenses for preclinical and
        clinical support of PEGPH20.
    --  Selling, general and administrative expenses for the fourth quarter were
        $10.6 million, compared to $8.4 million for the fourth quarter of 2014.
        The increase was primarily due to an increase in personnel expenses,
        including stock compensation, for the period.
    --  Net income for the fourth quarter was $4.3 million, or $0.03 per share,
        compared to a net loss in the fourth quarter of 2014 of $5.3 million, or
        $0.04 per share. The net loss for the full year totaled $32.2 million,
        or $0.25 per share, compared to a net loss of $68.4 million, or $0.56
        per share, for 2014.
    --  Cash, cash equivalents and marketable securities were $108.3 million at
        Dec. 31, compared to $123.7 million at Sept. 30, 2015.  Net cash burn
        during 2015 was approximately $27.3 million.

Financial Outlook for 2016
For the full year 2016, the company maintains its previously announced guidance of:


    --  Net revenues to be in the range of $110 million to $125 million;
    --  Operating expenses to be in the range of $240 million to $260 million;
    --  Cash Flow to be in the range of $35 million to $55 million; and
    --  Year-end cash balance of $140 million to $160 million.

Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the fourth quarter and full year 2015 today, Monday, February 29 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call. 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 and additional documents related to the call, please visit http://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) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available shortly after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay passcode 11528439.

About Halozyme
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme's lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie and Lilly for its ENHANZE(TM) drug delivery platform. Halozyme is headquartered in San Diego. 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, statements concerning the Company's future expectations and plans for growth in 2016, the development and commercialization of product candidates and the potential benefits and attributes of such product candidates and expected financial outlook for 2016) 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 fluctuations or changes in revenues, including revenues from collaborators, unexpected results or delays in development of product candidates 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 February 29, 2016.

Contacts:
Jim Mazzola
858-704-8122
ir@halozyme.com

Chris Burton
858-704-8352
ir@halozyme.com


                                          Halozyme Therapeutics, Inc.

                                Condensed Consolidated Statements of Operations

                                                  (Unaudited)

                                   (In thousands, except per share amounts)


                                                Three Months Ended                     Year Ended

                                                 December 31,                    December 31,

                                                   2015                     2014                  2015        2014
                                                   ----                     ----                  ----        ----

    Revenues:

    Product sales, net                          $13,579                  $10,144               $46,082     $37,823

    Revenues under
     collaborative agreements                    29,104                   16,190                58,000      28,086

    Royalties                                     9,544                    4,043                30,975       9,425


    Total revenues                               52,227                   30,377               135,057      75,334
                                                 ------                   ------               -------      ------


    Operating expenses:

    Cost of product sales                         8,427                    6,147                29,245      22,732

    Research and development                     27,746                   19,728                93,236      79,696

    Selling, general and
     administrative                              10,589                    8,353                40,028      35,942


    Total operating expenses                     46,762                   34,228               162,509     138,370
                                                 ------                   ------               -------     -------


    Operating income (loss)                       5,465                  (3,851)             (27,452)   (63,036)


    Other income (expense):

    Investment and other
     income, net                                    155                     (45)                  422         242

    Interest expense                            (1,302)                 (1,378)              (5,201)    (5,581)
                                                 ------                   ------                ------      ------


    Net income (loss)                            $4,318                 $(5,274)            $(32,231)  $(68,375)
                                                 ======                  =======              ========    ========


    Basic net income (loss) per
     share                                        $0.03                  $(0.04)              $(0.25)    $(0.56)
                                                  =====                   ======                ======      ======

    Diluted net income (loss)
     per share                                    $0.03                  $(0.04)              $(0.25)    $(0.56)
                                                  =====                   ======                ======      ======


    Shares used in computing
     basic net income (loss)
     per share:                                 127,197                  124,272               126,704     122,690
                                                =======                  =======               =======     =======

    Shares used in computing
     diluted net income (loss)
     per share:                                 129,248                  124,272               126,704     122,690
                                                -------                  -------               -------     -------



                        Halozyme Therapeutics, Inc.

                   Condensed Consolidated Balance Sheets

                                (Unaudited)

                              (In thousands)

                                                        December 31,

                                                         2015              2014
                                                         ----              ----


    ASSETS


    CURRENT ASSETS:

    Cash and cash equivalents                         $43,292           $61,389

    Marketable securities,
     available-for-sale                                65,047            74,234

    Accounts receivable, net                           32,410             9,149

    Inventories                                         9,489             6,406

    Prepaid expenses and other
     assets                                            21,534            10,143
                                                       ------            ------

    Total current assets                              171,772           161,321


    Property and equipment, net                         3,943             2,951

    Prepaid expenses and other
     assets                                             5,574             1,205

    Restricted cash                                       500               500
                                                          ---


          Total Assets                               $181,789          $165,977
                                                     ========          ========


    LIABILITIES AND STOCKHOLDERS' EQUITY


    CURRENT LIABILITIES:

    Accounts payable                                   $4,499            $3,003

    Accrued expenses                                   26,792            13,961

    Deferred revenue, current
     portion                                            9,304             7,367

    Current portion of long-term
     debt, net                                         21,862                 -

          Total current liabilities                    62,457            24,331


    Deferred revenue, net of current
     portion                                           43,919            47,267

    Long-term debt, net                                27,971            49,860

    Other long-term liabilities                         4,443             3,167


    STOCKHOLDERS' EQUITY:

    Common stock                                          128               126

    Additional paid-in capital                        525,628           491,694

    Accumulated other comprehensive
     loss                                                (99)             (41)

    Accumulated deficit                             (482,658)        (450,427)
                                                     --------          --------

          Total Stockholders' Equity                   42,999            41,352
                                                       ------            ------


          Total Liabilities and
           Stockholders' Equity                      $181,789          $165,977
                                                     --------          --------

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