1. SAN DIEGO, Feb. 24, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) ("Halozyme" or the "Company"), a leader in converting IV biologics to subcutaneous delivery, today announced the pricing of $700 million aggregate principal amount of its convertible senior notes due 2027 (the "Convertible Notes"). The Convertible Notes are being offered in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The Company granted an option to the initial purchasers to purchase up to an additional $105 million aggregate principal amount of Convertible Notes.

    The Convertible Notes will be senior, unsecured, obligations of the Company, will pay interest semi-annually…

    SAN DIEGO, Feb. 24, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) ("Halozyme" or the "Company"), a leader in converting IV biologics to subcutaneous delivery, today announced the pricing of $700 million aggregate principal amount of its convertible senior notes due 2027 (the "Convertible Notes"). The Convertible Notes are being offered in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The Company granted an option to the initial purchasers to purchase up to an additional $105 million aggregate principal amount of Convertible Notes.

    The Convertible Notes will be senior, unsecured, obligations of the Company, will pay interest semi-annually in arrears at an annual rate of 0.25% and under certain circumstances, will be convertible into cash and, if applicable, shares of the Company's common stock, at the Company's election. The Convertible Notes have an initial conversion rate of 12.9576 shares of the Company's common stock per $1,000 principal amount of Convertible Notes (which is equivalent to an initial conversion price of approximately $77.17 per share of the Company's common stock, representing an initial conversion premium of approximately 50% above the closing price of $51.45 per share of the Company's common stock on February 24, 2021). The conversion rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. Holders of the Convertible Notes will have the right to require the Company to repurchase all or a portion of their Convertible Notes upon the occurrence of a fundamental change (as defined in the indenture governing the Convertible Notes) at a cash repurchase price of 100% of their principal amount plus any accrued and unpaid interest. The Convertible Notes will mature on March 1, 2027, unless repurchased, redeemed or converted in accordance with their terms prior to such date. Prior to the close of business on the business day immediately preceding September 1, 2026, the Convertible Notes will be convertible only upon the satisfaction of certain conditions and during certain periods, and on and after September 1, 2026, at any time prior to the close of business on the scheduled trading day immediately preceding the maturity date regardless of these conditions. The Company expects to close the offering on March 1, 2021, subject to the satisfaction of various customary closing conditions.

    The Company will receive net proceeds from the offering of approximately $681.9 million (or approximately $784.3 million if the initial purchasers exercise their option to purchase additional Convertible Notes in full). The Company expects to use a portion of the net proceeds of the offering to enter into privately negotiated agreements with certain holders of its outstanding 1.25% convertible senior notes due 2024 (the "Existing Convertible Notes") to exchange their Existing Convertible Notes for a combination of cash and shares of its common stock through privately negotiated transactions entered into concurrently with or shortly after the offering (the "Note Repurchases"). In connection with the Note Repurchases, the Company expects to pay approximately $370.2 million in cash, which includes accrued interest, and issue approximately 9.08 million shares of its common stock, to settle such exchanges. In addition, the Company plans to use up to $75.0 million of the net proceeds from the offering to repurchase shares of its common stock under its existing stock repurchase program (the "Share Repurchases").

    These Note Repurchases and Share Repurchases could increase (or reduce the size of any decrease in) the market price of Halozyme common stock or the Convertible Notes. We also expect that some existing noteholders may purchase or sell shares of the Company's common stock in the market to hedge their exposure in connection with these transactions. The Note Repurchases, Share Repurchases and any associated hedging by holders could have affected or affect the market price of the Company's common stock prior to, concurrently with or shortly after the pricing of the Convertible Notes, and could have also resulted in a higher effective conversion price for the Convertible Notes.

    The Company intends to use the remainder of the net proceeds from the offering for general corporate purposes, including other repurchases of the Company's common stock from time to time under its existing stock repurchase program, working capital, capital expenditures, potential acquisitions and strategic transactions. If the initial purchasers exercise their option to purchase additional Convertible Notes, the Company intends to use net proceeds from the sale of additional Convertible Notes for general corporate purposes. 

    This press release is neither an offer to sell nor a solicitation of an offer to buy the Convertible Notes or the shares of the Company's common stock issuable upon conversion of the Convertible Notes, if any, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offer of these securities will be made only by means of a private offering memorandum.

    The offer and sale of the Convertible Notes and the shares of the Company's common stock issuable upon conversion of the Convertible Notes, if any, have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and the Convertible Notes and such shares may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

    Forward-looking Statements:

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the planned offering. Words such as "anticipates," "estimates," "expects," "projects," "forecasts," "intends," "plans," "will," "believes" and words and terms of similar substance used in connection with any discussion identify forward-looking statements. These forward-looking statements are based on management's current expectations and beliefs about future events and are inherently susceptible to uncertainty and changes in circumstances. Except as required by law, the Company is under no obligation to, and expressly disclaim any obligation to, update or alter any forward-looking statements whether as a result of such changes, new information, subsequent events or otherwise. With respect to the planned offering, such uncertainties and circumstances include whether the Company will consummate the offering; and the use of the net proceeds from the offering. Various factors could also adversely affect the Company's operations, business or financial results in the future and cause the Company's actual results to differ materially from those contained in the forward-looking statements, including those factors discussed in detail in the "Risk Factors" sections contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2020 which is filed with the Securities and Exchange Commission.

    About Halozyme Therapeutics, Inc.

    Halozyme is a biopharmaceutical company focused on bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx and Horizon Therapeutics. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

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    SOURCE Halozyme Therapeutics, Inc.

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  2. SAN DIEGO, Feb. 23, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) ("Halozyme" or the "Company"), a leader in converting IV biologics to subcutaneous delivery, today announced that it intends to offer, subject to market conditions and other factors, $500 million aggregate principal amount of convertible senior notes due 2027 (the "Convertible Notes"). The Convertible Notes are to be offered and sold to "qualified institutional buyers" pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The Company also expects to grant a 30-day option to the initial purchasers to purchase up to an additional $75 million aggregate principal amount of Convertible Notes.

    The Convertible Notes will be senior…

    SAN DIEGO, Feb. 23, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) ("Halozyme" or the "Company"), a leader in converting IV biologics to subcutaneous delivery, today announced that it intends to offer, subject to market conditions and other factors, $500 million aggregate principal amount of convertible senior notes due 2027 (the "Convertible Notes"). The Convertible Notes are to be offered and sold to "qualified institutional buyers" pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"). The Company also expects to grant a 30-day option to the initial purchasers to purchase up to an additional $75 million aggregate principal amount of Convertible Notes.

    The Convertible Notes will be senior, unsecured obligations of the Company and will accrue interest payable semiannually in arrears. The Convertible Notes will mature on March 1, 2027, unless earlier redeemed, repurchased or converted in accordance with their terms. Prior to September 1, 2026, the Convertible Notes will be convertible only upon the satisfaction of certain conditions and during certain periods, and on and after September 1, 2026, at any time prior to the close of business on the scheduled trading day immediately preceding the maturity date, the Convertible Notes will be convertible regardless of these conditions. The Company will settle conversions in cash and, if applicable, shares of the Company's common stock. The initial conversion rate, interest rate and other terms of the Convertible Notes will be determined at the time of pricing in negotiations with the initial purchasers of the Convertible Notes.

    The Company expects to use a portion of the net proceeds of the offering to enter into privately negotiated agreements with certain holders of its outstanding 1.25% convertible senior notes due 2024 (the "Existing Convertible Notes") to exchange their Existing Convertible Notes for a combination of cash and shares of its common stock through privately negotiated transactions entered into concurrently with or shortly after the pricing of the proposed offering (the "Note Repurchases"). In addition, the Company plans to use up to $75 million of the net proceeds of the offering to repurchase shares of its common stock under the existing stock repurchase program described below (the "Share Repurchases"), concurrently with, or shortly after, the pricing of the offering in privately negotiated transactions or otherwise, which may be effected through one or more of the initial purchasers or any affiliate thereof.

    These Note Repurchases and Share Repurchases could increase (or reduce the size of any decrease in) the market price of Halozyme common stock or the Convertible Notes. We also expect that some existing noteholders may purchase or sell shares of the Company's common stock in the market to hedge their exposure in connection with these transactions. The Note Repurchases, Share Repurchases and any associated hedging by holders could affect the market price of the Company's common stock prior to, concurrently with or shortly after the pricing of the Convertible Notes and could also result in a higher effective conversion price for the Convertible Notes.

    The Company intends to use the remainder of the net proceeds from the offering for general corporate purposes, including other repurchases of the Company's common stock from time to time under the existing stock repurchase program described below, working capital, capital expenditures, potential acquisitions and strategic transactions. If the initial purchasers exercise their option to purchase additional notes, the Company intends to use net proceeds from the sale of additional notes for general corporate purposes.

    This press release is neither an offer to sell nor a solicitation of an offer to buy the Convertible Notes or the shares of the Company's common stock issuable upon conversion of the Convertible Notes, if any, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. Any offer of these securities will be made only by means of a private offering memorandum.

    The offer and sale of the Convertible Notes and the shares of the Company's common stock issuable upon conversion of the Convertible Notes, if any, have not been registered under the Securities Act, or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

    Existing Stock Repurchase Program

    In November 2019, the Board of Directors of the Company authorized a capital return program to repurchase up to $550.0 million of outstanding common stock over a three-year period. As of December 31, 2020, $200 million of Halozyme's common stock remained available for repurchase under this program.

    Forward-looking Statements:

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the planned offering. Words such as "anticipates," "estimates," "expects," "projects," "forecasts," "intends," "plans," "will," "believes" and words and terms of similar substance used in connection with any discussion identify forward-looking statements. These forward-looking statements are based on management's current expectations and beliefs about future events and are inherently susceptible to uncertainty and changes in circumstances. Except as required by law, the Company is under no obligation to, and expressly disclaim any obligation to, update or alter any forward-looking statements whether as a result of such changes, new information, subsequent events or otherwise. With respect to the planned offering, such uncertainties and circumstances include whether the Company will offer the notes or consummate the offering; and the anticipated terms of the notes and the use of the net proceeds from the offering. Various factors could also adversely affect the Company's operations, business or financial results in the future and cause the Company's actual results to differ materially from those contained in the forward-looking statements, including those factors discussed in detail in the "Risk Factors" sections contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2020 which is filed with the Securities and Exchange Commission.

    About Halozyme Therapeutics, Inc.

    Halozyme is a biopharmaceutical company focused on bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx and Horizon Therapeutics. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

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    SOURCE Halozyme Therapeutics, Inc.

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  3. SAN DIEGO, Feb. 23, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today reported financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on its recent corporate activities and outlook.

    "The fourth quarter capped an extraordinary year for Halozyme during which we transitioned to a profitable, high-growth company with strong prospects for continued growth over the long-term," said Dr. Helen Torley, president and chief executive officer. "Our  strong growth prospects are fueled by recent product approvals for subcutaneous DARZALEX® (daratumumab) and Phesgo® (pertuzumab, trastuzumab and hyaluronidase) utilizing our ENHANZE® technology.  Building on our portfolio of 5 commercialized partner…

    SAN DIEGO, Feb. 23, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today reported financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on its recent corporate activities and outlook.

    "The fourth quarter capped an extraordinary year for Halozyme during which we transitioned to a profitable, high-growth company with strong prospects for continued growth over the long-term," said Dr. Helen Torley, president and chief executive officer. "Our  strong growth prospects are fueled by recent product approvals for subcutaneous DARZALEX® (daratumumab) and Phesgo® (pertuzumab, trastuzumab and hyaluronidase) utilizing our ENHANZE® technology.  Building on our portfolio of 5 commercialized partner products, we project the expansion of our development pipeline, including 4 products being evaluated in 7 phase 3 studies utilizing our ENHANZE® technology.  We believe this advancing pipeline of products utilizing our ENHANZE® technology is setting the potential for multiple waves of future product launches that will deliver long-term growth in revenues, profitability and cash flow."

    Fourth Quarter 2020 and Recent Highlights Include:

    • In February 2021, argenx announced a "go" decision for its ADHERE trial evaluating subcutaneous (SC) efgartigimod with ENHANZE® technology in chronic inflammatory demyelinating polyneuropathy (CIDP). argenx plans to continue enrollment to include approximately 130 patients to support potential registration of SC efgartigimod for the treatment of CIDP.
    • In January 2021, ENHANZE® partner Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) accelerated approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. AL amyloidosis is a rare and potentially fatal disease that develops when plasma cells in the bone marrow generate abnormal light chains, which form amyloid deposits in vital organs and lead to organ deterioration. There were previously no approved therapies for the disease.
    • In January 2021, argenx initiated a Phase 3 study of ARGX-113 with ENHANZE® technology in pemphigus vulgaris and pemphigus foliaceus, rare autoimmune diseases that cause painful blisters on the skin and mucous membranes.
    • In December 2020, argenx initiated a Phase 3 study of ARGX-113 with ENHANZE® technology for patients with immune thrombocytopenia (ITP), an immune disorder in which the blood does not clot normally, resulting in a $15 million payment to Halozyme.
    • In December 2020, Roche initiated a Phase 3 study in patients with non-small cell lung cancer for Tecentriq® (atezolizumab) with ENHANZE® technology, resulting in a $17 million payment to Halozyme.
    • In December 2020, the Company announced that the European Commission approved Roche's Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with ENHANZE® technology, administered by SC injection for the treatment of patients with early and metastatic HER2-positive breast cancer. This was the first time the European Commission approved a product combining two monoclonal antibodies that can be administered by a single SC injection utilizing  ENHANZE® technology.
    • In November 2020, the Company announced a global collaboration and license agreement that provides Horizon Therapeutics plc exclusive access to ENHANZE® technology for SC formulation of medicines targeting IGF-1R for which the Company received an upfront payment of $30 million. Horizon intends to use ENHANZE® technology to develop a SC formulation of TEPEZZA® (teprotumumab-trbw), indicated for the treatment of Thyroid Eye Disease, a serious, progressive and vision-threatening rare autoimmune disease, potentially shortening drug administration time, reducing healthcare practitioner time and offering additional flexibility and convenience for patients.
    • In November 2020, Janssen initiated a Phase 1 study of amivantamab utilizing ENHANZE® technology in advanced solid tumors.
    • In November 2020, the Company announced that Janssen submitted regulatory applications to the FDA and European Medicines Agency (EMA) seeking approval of DARZALEX FASPRO® in the U.S. and as DARZALEX® SC in the European Union (EU) utilizing ENHANZE® technology in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
    • In November 2020, Janssen submitted a Type II variation application to the EMA seeking European approval for DARZALEX® SC utilizing ENHANZE® technology to be used in the treatment of patients with AL amyloidosis.
    • In October 2020, the Company announced that argenx expanded its existing global collaboration and license agreement that was signed in February 2019. Under the expansion, argenx gained the ability to exclusively access Halozyme's ENHANZE® drug delivery technology for three additional targets upon nomination for a total of up to six targets. To date, argenx has nominated two targets including the human neonatal Fc receptor FcRn, which is blocked by efgartigimod, and complement component C2.
    • During the fourth quarter, the Company repurchased approximately 1.1 million shares of common stock for $37.6 million at an average price per share of $34.36, bringing the total 2020  repurchases to $150.0 million at an average price of $23.05.

    Fourth Quarter and Full Year 2020 Financial Highlights

    • Revenue for the fourth quarter was $121.7 million compared to $53.7 million for the fourth quarter of 2019. The year-over-year increase was primarily driven by a $30.0 million upfront payment from Horizon, a $15.0 million sales milestone from Janssen, an increase in royalty revenue following the strong DARZALEX FASPRO® launch during the second quarter and  an increase in product sales. Revenue for the quarter included $32.0 million in royalties, an increase of 86% compared to $17.2 million in the prior year period.

      Total revenues for the full year were $267.6 million, compared with $196.0 million in 2019, representing growth of 37% year over year.
    • Research and development expenses for the fourth quarter were $7.4 million, compared to $45.1 million for the fourth quarter of 2019. The decrease in expenses was due to a decrease in clinical trial activities-related costs as a result of the Company halting its oncology drug development efforts beginning in November 2019 and one-time restructuring charges of $17.2 million in the prior year related to the shift in strategic focus to the Company's ENHANZE® technology.

      Research and development expenses for the full year were $34.2 million, compared with $140.8 million in 2019.
    • Selling, general and administrative expenses for the fourth quarter were $10.4 million, compared to $23.9 million for the fourth quarter of 2019. The decrease was due to lower compensation and commercial-related expenses related to the corporate restructuring announced in November 2019 and a one-time restructuring charge of $11.2 million in the prior year.

      Selling, general and administrative expenses for the full year were $45.7 million, compared with $77.3 million in 2019.
    • Operating income for the fourth quarter was $77.6 million, compared to an operating loss of $32.1 million in the fourth quarter of 2019.

      Operating income for the full year was $144.3 million, compared to an operating loss of $67.6 million in 2019. 
    • Net income for the fourth quarter was $73.2 million, or $0.50 per share, compared to a net loss in the fourth quarter of 2019 of $34.4 million, or loss of $0.24 per share.

      Net income for the full year was $129.1 million or $0.91 per share, compared to a net loss of $72.2 million or loss of $0.50 per share in 2019.
    • Cash, cash equivalents and marketable securities were $368.0 million at December 31, 2020, compared to $421.3 million at December 31, 2019.
    • During 2020, the Company repurchased 6.5 million shares of common stock for $150 million at an average price of $23.05, bringing the total for share repurchases since the announcement of the Company's three-year share repurchase program to $350.0 million at an average price of $19.88.

    Financial Outlook for 2021

    Based on the latest information from collaboration partners and planned expenditures for the year, the Company expects:

    • Revenues of $375 million to $395 million, representing year-over-year growth of 40%-48%, with revenues from royalties projected to approximately double versus 2020;
    • Operating Income of $215 million to $235 million, representing year-over-year growth of 49%-63%;
    • Earnings per share on a GAAP basis of $1.40 to $1.55, representing year-over-year growth of 54%-70%.

    The Company plans to repurchase up to $125 million in common stock during 2021 as part of the $550 million three-year share repurchase plan authorized by Halozyme's board of directors in 2019. The amount and timing of shares to be repurchased in 2021 will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements.

    Webcast and Conference Call

    Halozyme will webcast its Quarterly Update Conference Call for the fourth quarter of 2020 today, Tuesday, February 23, 2021 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme's corporate website and a replay will be available following the close of the call. To register for this conference call, please use this link: http://www.directeventreg.com/registration/event/7096809. After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx and Horizon Therapeutics. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. 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 in this press release include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance (including the Company's financial outlook for 2021) and expectations for future growth, profitability, revenue, operating income, cash flow, expenses and earnings-per-share and the Company's plans to continue its share repurchase program. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's ENHANZE® business may include potential growth driven by our partners' development and commercialization efforts, the size and growth prospects of our partners' drug franchises, potential new ENHANZE® collaborations and collaborative targets and regulatory review and potential approvals of new ENHANZE® products. These 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 and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, inability to sustain profitability, unexpected delays in the execution of the Company's  share repurchase program, unexpected results or delays in the growth of the Company's ENHANZE® business, or in the development, regulatory review or commercialization of ENHANZE® products, including any potential delays caused by the current COVID-19 global pandemic, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-K filed with the Securities and Exchange Commission.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122



    Halozyme Therapeutics, Inc

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per share amounts)





    Three Months Ended

     December 31,



    Twelve Months Ended

    December 31,



    2020



    2019



    2020



    2019

    Revenues:















    Royalties

    $

    31,997





    $

    17,230





    $

    88,596





    $

    69,899



    Product sales, net

    32,455





    22,693





    55,987





    66,048



    Revenues under collaborative agreements

    57,251





    13,742





    123,011





    60,045



    Total revenues

    121,703





    53,665





    267,594





    195,992



    Operating expenses:















    Cost of product sales

    26,272





    16,687





    43,367





    45,546



    Research and development

    7,380





    45,111





    34,236





    140,804



    Selling, general and administrative

    10,427





    23,929





    45,736





    77,252



    Total operating expenses

    44,079





    85,727





    123,339





    263,602



    Operating income (loss)

    77,624





    (32,062)





    144,255





    (67,610)



    Other income (expense):















    Investment and other income, net

    661





    1,333





    5,425





    6,986



    Interest expense

    (5,036)





    (3,731)





    (20,378)





    (11,627)



    Net income (loss) before income taxes

    73,249





    (34,460)





    129,302





    (72,251)



    Income tax expense

    85





    (63)





    217





    (11)



    Net income (loss)

    $

    73,164





    $

    (34,397)





    $

    129,085





    $

    (72,240)



















    Net income (loss) per share:















    Basic

    $

    0.54





    $

    (0.24)





    $

    0.95





    $

    (0.50)



    Diluted

    $

    0.50





    $

    (0.24)





    $

    0.91





    $

    (0.50)



















    Shares used in computing net income (loss) per share:















    Basic

    135,107





    141,046





    136,206





    144,329



    Diluted

    145,122





    141,046





    141,463





    144,329









    Halozyme Therapeutics, Inc

    Condensed Consolidated Balance Sheets

    (Unaudited)

    (In thousands)





    December 31,

    2020



    December 31,

    2019

    ASSETS







    Current assets:







    Cash and cash equivalents

    $

    147,703





    $

    120,179



    Marketable securities, available-for-sale

    220,310





    301,083



    Accounts receivable, net and other contract assets

    97,730





    59,442



    Inventories

    60,747





    29,359



    Prepaid expenses and other assets

    28,274





    33,373



    Total current assets

    554,764





    543,436



    Property and equipment, net

    10,593





    10,855



    Prepaid expenses and other assets

    14,067





    11,083



    Restricted cash

    500





    500



    Total assets

    $

    579,924





    $

    565,874











    LIABILITIES AND STOCKHOLDERS' EQUITY







    Current liabilities:







    Accounts payable

    $

    1,928





    $

    6,434



    Accrued expenses

    20,483





    55,649



    Deferred revenue, current portion

    1,746





    4,012



    Current portion of long-term debt, net

    397,228





    19,542



    Total current liabilities

    421,385





    85,637











    Deferred revenue, net of current portion

    4,026





    1,247



    Long-term debt, net





    383,045



    Other long-term liabilities

    3,466





    4,180











    Stockholders' equity:







    Common stock

    135





    137



    Additional paid-in capital

    625,483





    695,066



    Accumulated other comprehensive income (loss)

    22





    240



    Accumulated deficit

    (474,593)





    (603,678)



    Total stockholders' equity

    151,047





    91,765



    Total liabilities and stockholders' equity

    $

    579,924





    $

    565,874



     

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  4. SAN DIEGO, Feb. 10, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) will webcast its Quarterly Update Conference Call for the fourth quarter 2020 on Tuesday, February 23 at 4:30 p.m. ET / 1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the fourth quarter ended December 31, 2020 following the close of trading.

    To register for this conference call, please use this link: http://www.directeventreg.com/registration/event/7096809. After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are…

    SAN DIEGO, Feb. 10, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) will webcast its Quarterly Update Conference Call for the fourth quarter 2020 on Tuesday, February 23 at 4:30 p.m. ET / 1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the fourth quarter ended December 31, 2020 following the close of trading.

    To register for this conference call, please use this link: http://www.directeventreg.com/registration/event/7096809. After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of 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 the Investors page of www.halozyme.com approximately 15 minutes prior to the call to register, download and install any necessary audio software. A telephone replay will be available for two weeks after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 7096809.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx and Horizon Therapeutics. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

     

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  5. SAN DIEGO, Jan. 15, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Janssen Biotech, Inc. (Janssen) has received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.1 DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this rare and serious blood disorder associated with the production of an abnormal protein which leads to the deterioration of vital organs, most notably the heart, kidneys and liver.1 This indication is approved under accelerated approval and is based…

    SAN DIEGO, Jan. 15, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Janssen Biotech, Inc. (Janssen) has received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.1 DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this rare and serious blood disorder associated with the production of an abnormal protein which leads to the deterioration of vital organs, most notably the heart, kidneys and liver.1 This indication is approved under accelerated approval and is based on the combination's hematologic complete response rate (hemCR) measure. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.  DARZALEX FASPRO® is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

    "We are delighted that DARZALEX FASPRO® utilizing our ENHANZE® technology has become the first and only FDA-approved treatment for newly diagnosed patients with AL amyloidosis," said Dr. Helen Torley, president and chief executive officer. "AL amyloidosis represents an area of high unmet medical need."

    The FDA approval is based on positive results from the Phase 3 ANDROMEDA study, which were recently presented at the American Society of Hematology (ASH) 2020 Annual Meeting. The study evaluated DARZALEX FASPRO® in combination with VCd, compared with VCd alone, a common treatment regimen offered to adult patients with newly diagnosed AL amyloidosis. 5  Patients receiving treatment with DARZALEX FASPRO® experienced a hemCR more than triple that of patients receiving VCd alone (42 percent for D-VCd and 13 percent for VCd; P<0.0001).1

    Approximately 4,500 people in the U.S. develop this rare disease each year.4  AL amyloidosis is a life-threatening blood cell disorder that occurs when blood plasma cells in the bone marrow produce amyloid deposits, which build up in vital organs and eventually cause organ deterioration.3  The disease can affect different organs in different people, but the most frequently affected organs are the heart, kidneys, liver, spleen, gastrointestinal tract and nervous system.2,3  About one-third of patients visit five or more doctors before receiving a diagnosis, and 72 percent are diagnosed more than one year after they first experience symptoms.3,4  Patients often have a poor prognosis due to the delay in diagnosis of AL amyloidosis, which frequently presents with non-specific symptoms that can mimic other, more common conditions.6  As many as 30 percent of patients with AL amyloidosis die within the first year after diagnosis.7   

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx and Horizon Therapeutics. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. 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 possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes from being treated with the newly-approved ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    1 DARZALEX FASPRO® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.

    2 Mayo Clinic. Amyloidosis overview: symptoms and causes. https://www.mayoclinic.org/diseases-conditions/amyloidosis/symptoms-causes/syc-20353178. Accessed January 2021.

    3 Lousada I, Comenzo RL, Landau H, et al. Light chain amyloidosis: patient experience survey from the Amyloidosis Research Consortium. Advances in Therapy. 2015;32(10):920-928.

    4 McCausland KL, et al. Patient. 2018;11(2):207-216.

    5 Kastritis E, et al. Subcutaneous Daratumumab + Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis: Primary Results from the Phase 3 ANDROMEDA Study. Available at: https://library.ehaweb.org/eha/2020/eha25th/303396/efstathios.kastritis.subcutaneous.daratumumab.2B.cycl%20ophosphamide.bortezomib.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Amedia%3D3%2Ace_i. Accessed January 2021. 

    Mayo Clinic. Amyloidosis diagnosis and treatment. https://mayocl.in/3jK50G4. Accessed January 2021.

    7 Merlini G, et al. Light chain amyloidosis: the heart of the problem. Haematologica. 2013;98(10):1492-1495.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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  6. SAN DIEGO, Jan. 11, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today introduced 2021 financial guidance and commented on its outlook for the year.

    "2020 was a year of tremendous accomplishment at Halozyme highlighted by our successful transition to revenue growth and profitability, 2 U.S. FDA approvals and 2 European Commission approvals for ENHANZE® partner products, and successful completion of $150 million in share repurchases in 2020," said Dr. Helen Torley, president and chief executive officer.  "We are delighted with the strong first six months post launch market adoption of DARZALEX FASPRO® in the US, which drove a return to royalty revenue growth in 2020.  In 2021 we expect continued strong revenue and earnings growth…

    SAN DIEGO, Jan. 11, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today introduced 2021 financial guidance and commented on its outlook for the year.

    "2020 was a year of tremendous accomplishment at Halozyme highlighted by our successful transition to revenue growth and profitability, 2 U.S. FDA approvals and 2 European Commission approvals for ENHANZE® partner products, and successful completion of $150 million in share repurchases in 2020," said Dr. Helen Torley, president and chief executive officer.  "We are delighted with the strong first six months post launch market adoption of DARZALEX FASPRO® in the US, which drove a return to royalty revenue growth in 2020.  In 2021 we expect continued strong revenue and earnings growth driven by continued uptake of subcutaneous DARZALEX® in US and international markets and by uptake of Roche's Phesgo®, which received approval from the European Commission in late December 2020.  In addition, we expect to create catalysts for growth well into the future based on the advancement of multiple partners' ENHANZE® drug development programs."

    Anticipated 2021 Key Events :

    • Strong subcutaneous DARZALEX® (daratumumab) royalty revenue growth driven by continued US and international market uptake;
    • Potential Ministry of Health, Labour and Welfare approval in Japan for Janssen's subcutaneous DARZALEX® utilizing ENHANZE®;
    • Potential U.S. FDA approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in light chain amyloidosis;
    • Strong Phesgo® (pertuzumab, trastuzumab and hyaluronidase) royalty revenue growth driven by adoption in US and Europe;
    • Two new products entering Phase 3 development, resulting in a total of 4 products in Phase 3, including Roche's TECENTRIQ® (atezolizumab) and argenx's efgartigimod;
    • Five new Phase 1 trial starts for ENHANZE® partner programs resulting in a total of 13 Phase 1 studies completed or ongoing by end of 2021;
    • Continued commitment to capital return with up to $125 million in share repurchases anticipated in 2021 as part of the $550 million three-year share repurchase plan authorized by Halozyme's board of directors in November 2019.

    2021 Financial Guidance

    For 2021, Halozyme expects revenues of $375 million to $395 million, representing growth of approximately 40% to 45% over 2020 expected revenue. This revenue guidance, per the Company's standard practice, excludes any potential new ENHANZE® deals. Notably, in comparison to 2020 expected results the Company expects a doubling in revenue from royalties, a significant increase in product sales related to API, and revenue under collaborative agreements in a similar range to the substantial milestones expected in 2020.

    The Company further expects GAAP earnings per share of $1.40 to $1.55, representing growth of approximately 55% to 70% over 2020 expected EPS. Guidance includes the impact of an accounting change for convertible notes which eliminates non-cash interest expense.

    Table 1. 2021 Financial Guidance







    Guidance Range

    Net Revenue

    $375 million to $395 million

    Earnings Per Share (GAAP)

    $1.40 to $1.55

    The Company plans to report fourth quarter and full year 2020 financial results on February 23, 2021.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx and Horizon Therapeutics. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. 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 in this presentation include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance (including the Company's financial outlook for 2021) and expectations for profitability, revenue, expenses and earnings-per-share and the Company's plans to continue its share repurchase program.  Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery of injectable medications through subcutaneous delivery.  Forward-looking statements regarding the Company's ENHANZE® business may include potential growth driven by our partners' development and commercialization efforts, potential new ENHANZE® collaborations and collaborative targets and regulatory approvals of new ENHANZE® products.  These 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 and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements.  Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected delays in the execution of the Company's share repurchase program, unexpected results or delays in the growth of the Company's ENHANZE® business or in the development, regulatory review or commercialization of ENHANZE® products, including any potential delays caused by the current COVID-19 global pandemic, regulatory approval requirements, unexpected adverse events, patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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  7. SAN DIEGO, Jan. 4, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will present virtually at the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 12:40 p.m. PT / 3:40 p.m. ET. The virtual conference will be held from January 11-14, 2021.

    An audio-only direct link of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 30 days following the event. To access the link, please visit Halozyme's website approximately 10 minutes prior to the presentation to register and download any necessary audio software.

    About Halozyme

    Halozyme is a biopharmaceutical…

    SAN DIEGO, Jan. 4, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will present virtually at the 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 12:40 p.m. PT / 3:40 p.m. ET. The virtual conference will be held from January 11-14, 2021.

    An audio-only direct link of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 30 days following the event. To access the link, please visit Halozyme's website approximately 10 minutes prior to the presentation to register and download any necessary audio software.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx and Horizon Therapeutics. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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  8. SAN DIEGO, Dec. 23, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the European Commission has approved Roche's Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with Halozyme's ENHANZE® technology, administered by subcutaneous injection for the treatment of patients with early and metastatic HER2-positive breast cancer. This is the first time the European Commission has approved a product combining two monoclonal antibodies that can be administered by a single subcutaneous injection utilizing Halozyme's ENHANZE® technology.

    "We are pleased that HER2-positive breast cancer patients in Europe will now have the option to receive this important therapy in a substantially…

    SAN DIEGO, Dec. 23, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the European Commission has approved Roche's Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with Halozyme's ENHANZE® technology, administered by subcutaneous injection for the treatment of patients with early and metastatic HER2-positive breast cancer. This is the first time the European Commission has approved a product combining two monoclonal antibodies that can be administered by a single subcutaneous injection utilizing Halozyme's ENHANZE® technology.

    "We are pleased that HER2-positive breast cancer patients in Europe will now have the option to receive this important therapy in a substantially shorter period of time than standard IV therapy," said Dr. Helen Torley, president and chief executive officer. "The approval of Phesgo® in Europe closes out a terrific year for Halozyme in which we received multiple regulatory clearances for products utilizing our ENHANZE® technology, including 2 U.S. FDA approvals and now two European Commission approvals."

    Phesgo® is available in single-dose vials and can be administered via subcutaneous injection in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose.(1) This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta® and Herceptin® using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines.(2,3)

    The approval of Phesgo® in Europe is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint, with Phesgo® showing non-inferior levels of Perjeta® and Herceptin® in the blood and demonstrated comparable efficacy versus IV administration of the two medicines. The safety profile of Phesgo® with chemotherapy was comparable to IV administration of Perjeta® plus Herceptin® and chemotherapy. No new safety signals were identified, including no meaningful difference in cardiac toxicity.(1,4)

    Phesgo® has the potential to help minimize pressure on healthcare systems by reducing administration time, as well as other costs associated with treatment, such as time spent in the infusion chair and drug preparation(5). In addition, Roche's phase II PHranceSCa study showed that 85% (136/160) of people receiving treatment for HER2-positive breast cancer preferred treatment under the skin to IV administration due to less time in the clinic and more comfortable treatment administration.(1)

    About ENHANZE® Technology

    Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx and Horizon Therapeutics. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Halozyme Safe Harbor Statement

    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients and treatment costs. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner including clinical trial results. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected treatment costs, adverse events or patient outcomes from being treated with the newly-approved ENHANZE® co-formulated product referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    References:

    (1) US Food and Drug Administration. Prescribing information for Phesgo.

    (2) US Food and Drug Administration. Prescribing Information for Herceptin. [Internet; cited June 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf.

    (3) US Food and Drug Administration. Prescribing Information for Perjeta [Internet; cited June 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf.

    (4) Tan A, et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study. Presented at SABCS, 2019 Dec 10-14; San Antonio, Texas. Abstract #PD4-07.

    (5) Tjalma, et al. Trastuzumab IV versus SC: A time, motion and cost assessment in a lean operating day care oncology unit. Presented at: SABCS; 2016 Dec 6-10; San Antonio, TX, USA. Abstract #P4-21-15.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

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    SOURCE Halozyme Therapeutics, Inc.

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  9. SAN DIEGO, Nov. 23, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that it is updating 2020 financial guidance to reflect the signing of a global collaboration and license agreement with Horizon Therapeutics plc.

    The Company is raising full year 2020 revenue guidance to $265 million to $275 million to reflect incremental anticipated revenues as Halozyme and its partners continue to execute on a number of fourth quarter revenue-related activities.

    The Company now expects:

    • Revenues of $265 million to $275 million, increased from prior guidance of $250 million to $260 million, representing growth of 35% to 40% over prior year revenues;

    • Earnings per share on a GAAP basis of $0.90 to $0.95, increased from prior guidance…

    SAN DIEGO, Nov. 23, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that it is updating 2020 financial guidance to reflect the signing of a global collaboration and license agreement with Horizon Therapeutics plc.

    The Company is raising full year 2020 revenue guidance to $265 million to $275 million to reflect incremental anticipated revenues as Halozyme and its partners continue to execute on a number of fourth quarter revenue-related activities.

    The Company now expects:

    • Revenues of $265 million to $275 million, increased from prior guidance of $250 million to $260 million, representing growth of 35% to 40% over prior year revenues;



    • Earnings per share on a GAAP basis of $0.90 to $0.95, increased from prior guidance of $0.80 to $0.85.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. 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 in this press release include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance (including the Company's financial outlook for 2020) and expectations for future growth, profitability, revenue, expenses and earnings-per-share. Forward-looking statements regarding the Company's ENHANZE®  business may include potential growth driven by our partners' development and commercialization efforts. These 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 and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected results or delays in the growth of the Company's ENHANZE® business, or in the development, regulatory review or commercialization of ENHANZE® products, including any potential delays caused by the current COVID-19 global pandemic, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-Q filed with the Securities and Exchange Commission.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/halozyme-raises-full-year-2020-guidance-301178597.html

    SOURCE Halozyme Therapeutics, Inc.

    View Full Article Hide Full Article
  10. DUBLIN and SAN DIEGO, Nov. 23, 2020 /PRNewswire/ -- Horizon Therapeutics plc (Nasdaq:  HZNP) and Halozyme Therapeutics, Inc. (Nasdaq:  HALO) today announced a global collaboration and license agreement that gives Horizon exclusive access to Halozyme's ENHANZE® drug delivery technology for subcutaneous (SC) formulation of medicines targeting IGF-1R.  Horizon intends to use ENHANZE® to develop a SC formulation of TEPEZZA (teprotumumab-trbw), indicated for the treatment of Thyroid Eye Disease, a serious, progressive and vision-threatening rare autoimmune disease,1 potentially shortening drug administration time, reducing healthcare practitioner time and offering additional flexibility and convenience for patients.

    Under the terms of the agreement…

    DUBLIN and SAN DIEGO, Nov. 23, 2020 /PRNewswire/ -- Horizon Therapeutics plc (Nasdaq:  HZNP) and Halozyme Therapeutics, Inc. (Nasdaq:  HALO) today announced a global collaboration and license agreement that gives Horizon exclusive access to Halozyme's ENHANZE® drug delivery technology for subcutaneous (SC) formulation of medicines targeting IGF-1R.  Horizon intends to use ENHANZE® to develop a SC formulation of TEPEZZA (teprotumumab-trbw), indicated for the treatment of Thyroid Eye Disease, a serious, progressive and vision-threatening rare autoimmune disease,1 potentially shortening drug administration time, reducing healthcare practitioner time and offering additional flexibility and convenience for patients.

    Under the terms of the agreement, Horizon will make an upfront payment of $30 million to Halozyme and is obligated to make potential future payments of up to $160 million in the aggregate, subject to achievement of specified development, regulatory and sales-based milestones.  Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialized medicines using the ENHANZE® technology.

    "Our goal with all of our medicines is to optimize the patient experience," said Tim Walbert, chairman, president and chief executive officer, Horizon.  "As we continue to explore subcutaneous administration for TEPEZZA to provide greater flexibility for patients and physicians, access to the ENHANZE® technology, which has been deployed successfully in multiple biologics, represents an important step in our development efforts."

    "We are thrilled to announce our tenth collaboration and license agreement for ENHANZE® and look forward to working closely with Horizon to develop TEPEZZA with ENHANZE®," said Dr. Helen Torley, president and chief executive officer, Halozyme.  "The launch of TEPEZZA has been one of the most successful and exciting launches in rare disease medicine and is making a difference in the lives of patients suffering from Thyroid Eye Disease."

    Horizon represents Halozyme's tenth global collaboration and license partner for the ENHANZE® technology.  These collaborations cover more than 50 therapeutic targets and include five commercialized products to date.

    About ENHANZE® Technology

    Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20).  rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin).  By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously.  ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections.  This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

    About Horizon

    Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases.  Our pipeline is purposeful:  we apply scientific expertise and courage to bring clinically meaningful therapies to patients.  We believe science and compassion must work together to transform lives.  For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

    Horizon Safe Harbor Statement 

    This press release contains forward-looking statements, including, but not limited to, statements related to the potential benefits of ENHANZE® and a subcutaneous formulation of TEPEZZA, Horizon's strategy, plans, objectives, expectations and intentions, including with respect to the potential development of a subcutaneous formulation of TEPEZZA, and other statements that are not historical facts. These forward-looking statements are based on Horizon's expectations and assumptions as of the date of this press release and inherently involve significant risks and uncertainties. Actual results may differ materially from those in these forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks associated with the development, regulatory approval and commercialization of novel medicines or formulations of existing medicines, as well as those described in Horizon's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings.  Forward-looking statements speak only as of the date of this press release and Horizon does not undertake any obligation to update or revise these statements, except as may be required by law.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies.  Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success.  As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets.  Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe.  Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients.  Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx and Horizon Therapeutics.  Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®.  Halozyme is headquartered in San Diego.  For more information visit www.halozyme.com.

    Halozyme Safe Harbor Statement

    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients.  These forward-looking statements also include statements regarding the product development and regulatory efforts of Halozyme's ENHANZE® partner and Halozyme's potential receipt of payments associated with   achievement of certain development, regulatory and sales-based milestones, and royalties on sales of commercialized products.  These forward-looking statements involve risks 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 uncertainties concerning whether development, regulatory and sales-based milestones will be achieved, uncertainties concerning whether collaborative products are ultimately developed or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission.  Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    About TEPEZZA

    INDICATION

    TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

    IMPORTANT SAFETY INFORMATION

    Warnings and Precautions

    Infusion Reactions:  TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity.  Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

    Preexisting Inflammatory Bowel Disease:  TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD).  Monitor patients with IBD for flare of disease.  If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

    Hyperglycemia:  Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA.  In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia.  Hyperglycemic events should be managed with medications for glycemic control, if necessary.  Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA.  Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.

    Adverse Reactions

    The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache and dry skin.

    For additional information on TEPEZZA, please see Full Prescribing Information at TEPEZZAhcp.com.

    References

    1. Barrio-Barrio J, et al. Graves' Ophthalmopathy:  VISA versus EUGOGO Classification, Assessment and Management. Journal of Ophthalmopathy. 2015;2015:1-16.

    Horizon contacts:

    Tina Ventura

    Senior Vice President, Investor Relations

    Ruth Venning

    Executive Director, Investor Relations

    U.S. Media Contacts:

    Geoff Curtis

    Executive Vice President, Corporate Affairs & Chief Communications Officer

    Ireland Media Contact:

    Gordon MRM

    Ray Gordon

    Halozyme contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/horizon-therapeutics-plc-and-halozyme-therapeutics-inc-enter-global-collaboration-and-license-agreement-for-enhanze-technology-301178530.html

    SOURCE Halozyme Therapeutics, Inc.

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  11. - Horizon to use ENHANZE® subcutaneous delivery technology for TEPEZZA® (teprotumumab-trbw) -

    Horizon Therapeutics plc (NASDAQ:HZNP) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced a global collaboration and license agreement that gives Horizon exclusive access to Halozyme's ENHANZE® drug delivery technology for subcutaneous (SC) formulation of medicines targeting IGF-1R. Horizon intends to use ENHANZE® to develop a SC formulation of TEPEZZA (teprotumumab-trbw), indicated for the treatment of Thyroid Eye Disease, a serious, progressive and vision-threatening rare autoimmune disease,1 potentially shortening drug administration time, reducing healthcare practitioner time and offering additional flexibility and convenience for patients…

    - Horizon to use ENHANZE® subcutaneous delivery technology for TEPEZZA® (teprotumumab-trbw) -

    Horizon Therapeutics plc (NASDAQ:HZNP) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced a global collaboration and license agreement that gives Horizon exclusive access to Halozyme's ENHANZE® drug delivery technology for subcutaneous (SC) formulation of medicines targeting IGF-1R. Horizon intends to use ENHANZE® to develop a SC formulation of TEPEZZA (teprotumumab-trbw), indicated for the treatment of Thyroid Eye Disease, a serious, progressive and vision-threatening rare autoimmune disease,1 potentially shortening drug administration time, reducing healthcare practitioner time and offering additional flexibility and convenience for patients.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201123005620/en/

    Under the terms of the agreement, Horizon will make an upfront payment of $30 million to Halozyme and is obligated to make potential future payments of up to $160 million in the aggregate, subject to achievement of specified development, regulatory and sales-based milestones. Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialized medicines using the ENHANZE® technology.

    "Our goal with all of our medicines is to optimize the patient experience," said Tim Walbert, chairman, president and chief executive officer, Horizon. "As we continue to explore subcutaneous administration for TEPEZZA to provide greater flexibility for patients and physicians, access to the ENHANZE® technology, which has been deployed successfully in multiple biologics, represents an important step in our development efforts."

    "We are thrilled to announce our tenth collaboration and license agreement for ENHANZE® and look forward to working closely with Horizon to develop TEPEZZA with ENHANZE®," said Dr. Helen Torley, president and chief executive officer, Halozyme. "The launch of TEPEZZA has been one of the most successful and exciting launches in rare disease medicine and is making a difference in the lives of patients suffering from Thyroid Eye Disease."

    Horizon represents Halozyme's tenth global collaboration and license partner for the ENHANZE® technology. These collaborations cover more than 50 therapeutic targets and include five commercialized products to date.

    About ENHANZE® Technology

    Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

    About Horizon

    Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

    Horizon Safe Harbor Statement

    This press release contains forward-looking statements, including, but not limited to, statements related to the potential benefits of ENHANZE® and a subcutaneous formulation of TEPEZZA, Horizon's strategy, plans, objectives, expectations and intentions, including with respect to the potential development of a subcutaneous formulation of TEPEZZA, and other statements that are not historical facts. These forward-looking statements are based on Horizon's expectations and assumptions as of the date of this press release and inherently involve significant risks and uncertainties. Actual results may differ materially from those in these forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks associated with the development, regulatory approval and commercialization of novel medicines or formulations of existing medicines, as well as those described in Horizon's filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release and Horizon does not undertake any obligation to update or revise these statements, except as may be required by law.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx and Horizon Therapeutics. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Halozyme Safe Harbor Statement

    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients. These forward-looking statements also include statements regarding the product development and regulatory efforts of Halozyme's ENHANZE® partner and Halozyme's potential receipt of payments associated with achievement of certain development, regulatory and sales-based milestones, and royalties on sales of commercialized products. These forward-looking statements involve risks 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 uncertainties concerning whether development, regulatory and sales-based milestones will be achieved, uncertainties concerning whether collaborative products are ultimately developed or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    About TEPEZZA

    INDICATION

    TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

    IMPORTANT SAFETY INFORMATION

    Warnings and Precautions

    Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

    Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

    Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.

    Adverse Reactions

    The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache and dry skin.

    For additional information on TEPEZZA, please see Full Prescribing Information at TEPEZZAhcp.com.

    References

    1. Barrio-Barrio J, et al. Graves' Ophthalmopathy: VISA versus EUGOGO Classification, Assessment and Management. Journal of Ophthalmopathy. 2015;2015:1-16.

    View Full Article Hide Full Article
  12. SAN DIEGO, Nov. 18, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will participate in a fireside chat presentation for the Piper Sandler 32nd Annual Virtual Healthcare Conference.  The virtual conference will be held from December 1-3, 2020.

    The pre-recorded fireside chat will be available online Wednesday, November 25 in the investor relations section of the company's website at https://www.halozyme.com/investors/events-and-webcast/

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its…

    SAN DIEGO, Nov. 18, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will participate in a fireside chat presentation for the Piper Sandler 32nd Annual Virtual Healthcare Conference.  The virtual conference will be held from December 1-3, 2020.

    The pre-recorded fireside chat will be available online Wednesday, November 25 in the investor relations section of the company's website at https://www.halozyme.com/investors/events-and-webcast/

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

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  13. SAN DIEGO, Nov. 13, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Roche's Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) utilizing ENHANZE®, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in the near future.

    "We are delighted that Phesgo®, the first combination of two established monoclonal…

    SAN DIEGO, Nov. 13, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Roche's Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) utilizing ENHANZE®, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. Based on this recommendation, a final decision regarding the approval of Phesgo is expected from the European Commission in the near future.

    "We are delighted that Phesgo®, the first combination of two established monoclonal antibodies with our ENHANZE® technology, administered in just 5-8 minutes, is one step closer to becoming available for patients with HER-2 positive breast cancer in the EU," said Dr. Helen Torley, president and chief executive officer.

    Phesgo® can be administered in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose1. This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta® and Herceptin® using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines2,3.

    The recommendation from the CHMP is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint, with Phesgo® showing non-inferior levels of Perjeta® in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta®. The safety profile of Phesgo® with chemotherapy was comparable to IV administration of Perjeta® plus Herceptin® and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhea and anemia1,4.

    The U.S. Food and Drug Administration recently expedited the approval of Phesgo for the treatment of early and metastatic HER2-positive breast cancer. Based on the decision of the treating physician and the preference of the patient, it can be administered by a healthcare professional in a treatment center or in a patient's home.

    About ENHANZE® Technology 

    Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Halozyme Safe Harbor Statement 

    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients. These forward-looking statements also include statements regarding the product development and regulatory approval efforts of Halozyme's ENHANZE® partner. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes from being treated with the  ENHANZE® co-formulated product referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    References:

    [1] US Food and Drug Administration. Prescribing information for Phesgo. [Internet; cited October 2020]. Available from:  https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761170s000lbl.pdf.

    [2] European Medicines Agency. Summary of Product Characteristics for Perjeta. [Internet; cited October 2020]. Available from: https://www.ema.europa.eu/en/documents/product-information/perjeta-epar-product-information_en.pdf

    [3] European Medicines Agency. Summary of Product Characteristics for Herceptin. [Internet; cited October 2020]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922.pdf 

    [4] Tan A, et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study. Presented at SABCS, 2019 Dec 10-14; San Antonio, Texas. Abstract #PD4-07.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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  14. SAN DIEGO, Nov. 12, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the Janssen Pharmaceutical Companies submitted regulatory applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of the daratumumab subcutaneous (SC) formulation, known as DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S. and as DARZALEX® (daratumumab) SC in the European Union (EU). The applications seek approval of the combination of DARZALEX FASPRO™/ DARZALEX® SC with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. As a fixed-dose formulation, DARZALEX…

    SAN DIEGO, Nov. 12, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the Janssen Pharmaceutical Companies submitted regulatory applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval of the daratumumab subcutaneous (SC) formulation, known as DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S. and as DARZALEX® (daratumumab) SC in the European Union (EU). The applications seek approval of the combination of DARZALEX FASPRO™/ DARZALEX® SC with pomalidomide and dexamethasone (D-Pd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. As a fixed-dose formulation, DARZALEX FASPRO™/ DARZALEX® SC can be administered over approximately three to five minutes under the skin, significantly less time than the intravenous (IV) formulation of DARZALEX®, which is given over several hours. 

    The supplemental Biologics License Application (sBLA) to the U.S. FDA and Type II variation application to the EMA are supported by positive findings from the Phase 3 APOLLO study (MMY3013), which met its primary endpoint of significantly longer progression-free survival (PFS) in patients with relapsed or refractory multiple myeloma who received D-Pd compared with Pd alone.1

    "We are pleased that Janssen has submitted applications in both the US and EU to expand the label for the subcutaneous form of DARZALEX® utilizing our ENHANZE® technology," said Dr. Helen Torley, president and chief executive officer. "We look forward to the subcutaneous forms of DARZALEX® becoming available for a broader group of patients with multiple myeloma, offering them the potential for reduced administration time from hours to minutes compared with the IV formulation."

    These applications are supported by positive results from the Phase 3 APOLLO study, which demonstrated improved significant progression-free survival in patients receiving the subcutaneous formulation of daratumumab.2

    Full results from the Phase 3 APOLLO study, a collaboration between Janssen Research & Development, LLC and the European Myeloma Network (EMN), will be presented in an oral session  at the upcoming American Society of Hematology (ASH) Annual Meeting on Sunday, December 6, 2020 at 3:00 p.m. ET (Abstract #412).

    The D-Pd regimen received approval from the U.S. FDA for the IV formulation of DARZALEX® in 2017 for patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. This regimen for the IV formulation is not approved for use in Europe by the EMA.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. 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 possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release DARZALEX® is a trademark of Janssen Pharmaceutica NV.

    References:

    1  Chari, Ajai et al. "Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma." Blood vol. 130,8 (2017): 974-981. doi:10.1182/blood-2017-05-785246

    2  Comparison of Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide and a Proteasome Inhibitor Daratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone (EMN14). Available at: https://clinicaltrials.gov/ct2/show/record/NCT03180736 Last accessed: October 2020.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

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  15. NEW YORK, Nov. 5, 2020 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P  MidCap 400 and SmallCap 600 effective prior to the opening of trading on Friday, November 13:

    • First Bancorp (NASD:FBNC) will replace AMAG Pharmaceuticals Inc. (NASD:AMAG) in the S&P SmallCap 600. Covis Group is acquiring AMAG Pharmaceuticals in a deal expected to be completed soon pending final conditions.
    • MGIC Investment Corp. (NYSE:MTG) will replace The Geo Group Inc. (NYSE:GEO) in the S&P MidCap 400, and The Geo Group will replace Gulfport Energy Corp. (NASD:GPOR) in the S&P SmallCap 600. Halozyme Therapeutics Inc.(NASD:HALO) will replace Mednax Inc. (NYSE:MD) in the S&P MidCap 400, and Mednax will replace Washington Prime Group Inc. (NYSE…

    NEW YORK, Nov. 5, 2020 /PRNewswire/ -- S&P Dow Jones Indices will make the following changes to the S&P  MidCap 400 and SmallCap 600 effective prior to the opening of trading on Friday, November 13:

    • First Bancorp (NASD:FBNC) will replace AMAG Pharmaceuticals Inc. (NASD:AMAG) in the S&P SmallCap 600. Covis Group is acquiring AMAG Pharmaceuticals in a deal expected to be completed soon pending final conditions.
    • MGIC Investment Corp. (NYSE:MTG) will replace The Geo Group Inc. (NYSE:GEO) in the S&P MidCap 400, and The Geo Group will replace Gulfport Energy Corp. (NASD:GPOR) in the S&P SmallCap 600. Halozyme Therapeutics Inc.(NASD:HALO) will replace Mednax Inc. (NYSE:MD) in the S&P MidCap 400, and Mednax will replace Washington Prime Group Inc. (NYSE:WPG) in the S&P SmallCap 600. The GEO Group and Mednax are more representative of the small-cap market space. Gulfport Energy and Washington Prime Group are no longer representative of the small-cap market space.

    Following is a summary of the changes that will take place prior to the open of trading on the effective date:

    Effective Date

    Index Name      

    Action

    Company Name

    Ticker

    GICS Sector

    November 13, 2020

    S&P MidCap 400

    Addition

    MGIC Investment

    MTG

    Financials



    S&P MidCap 400

    Addition

    Halozyme Therapeutics

    HALO

    Health Care



    S&P MidCap 400

    Deletion

    Geo Group

    GEO

    Real Estate



    S&P MidCap 400

    Deletion

    Mednax

    MD

    Health Care



    S&P SmallCap 600

    Addition

    First Bancorp

    FBNC

    Financials



    S&P SmallCap 600

    Addition

    Geo Group

    GEO

    Real Estate



    S&P SmallCap 600

    Addition

    Mednax

    MD

    Health Care



    S&P SmallCap 600

    Deletion

    AMAG Pharmaceuticals

    AMAG

    Health Care



    S&P SmallCap 600

    Deletion

    Gulfport Energy

    GPOR

    Energy



    S&P SmallCap 600

    Deletion

    Washington Prime Group

    WPG

    Real Estate

    For more information about S&P Dow Jones Indices, please visit www.spdji.com

    ABOUT S&P DOW JONES INDICES

    S&P Dow Jones Indices is the largest global resource for essential index-based concepts, data and research, and home to iconic financial market indicators, such as the S&P 500® and the Dow Jones Industrial Average®. More assets are invested in products based on our indices than products based on indices from any other provider in the world. Since Charles Dow invented the first index in 1884, S&P DJI has been innovating and developing indices across the spectrum of asset classes helping to define the way investors measure and trade the markets.

    S&P Dow Jones Indices is a division of S&P Global (NYSE:SPGI), which provides essential intelligence for individuals, companies, and governments to make decisions with confidence. For more information, visit www.spdji.com.

    FOR MORE INFORMATION:

    S&P Dow Jones Indices

    Media Inquiries

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  16. SAN DIEGO, Nov. 5, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that studies sponsored by Janssen Research & Development, LLC (Janssen) evaluating subcutaneous (SC) daratumumab utilizing ENHANZE® will be the subject of presentations at the upcoming American Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.

    Primary data from the Phase 3 APOLLO study of SC daratumumab in combination with pomalidomide and dexamethasone (D-Pd) in patients with multiple myeloma who have received one or more prior lines of therapy (Abstract #412) will be the subject of an oral presentation and official ASH Press Program (Sunday, December 6 3:00 p.m. ET).

    Results from the Phase 3…

    SAN DIEGO, Nov. 5, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that studies sponsored by Janssen Research & Development, LLC (Janssen) evaluating subcutaneous (SC) daratumumab utilizing ENHANZE® will be the subject of presentations at the upcoming American Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.

    Primary data from the Phase 3 APOLLO study of SC daratumumab in combination with pomalidomide and dexamethasone (D-Pd) in patients with multiple myeloma who have received one or more prior lines of therapy (Abstract #412) will be the subject of an oral presentation and official ASH Press Program (Sunday, December 6 3:00 p.m. ET).

    Results from the Phase 3 ANDROMEDA study of SC daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) in patients with light chain AL amyloidosis (Abstract #552) will be the subject of an oral presentation (Monday, December 7 11:15 a.m. ET).  The ANDROMEDA study will also be the subject of four poster presentations (Abstracts #1392, #1640, #1409 and #2305).

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Halozyme Safe Harbor Statement

    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

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  17. SAN DIEGO, Nov. 2, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today reported financial results for the third quarter ended September 30, 2020 and provided an update on its recent corporate activities and outlook.

    "I am pleased to report the first quarter of what the Company projects will be sustainable royalty revenue growth, primarily driven by the strong uptake of Janssen's DARZALEX® SC with our ENHANZE® technology," said Dr. Helen Torley, president and chief executive officer. "In addition, we achieved higher milestone-related revenues in the quarter driven by partner clinical trial progress. Based on the improved outlook for royalties and greater visibility on anticipated milestone revenues, we are increasing our full…

    SAN DIEGO, Nov. 2, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today reported financial results for the third quarter ended September 30, 2020 and provided an update on its recent corporate activities and outlook.

    "I am pleased to report the first quarter of what the Company projects will be sustainable royalty revenue growth, primarily driven by the strong uptake of Janssen's DARZALEX® SC with our ENHANZE® technology," said Dr. Helen Torley, president and chief executive officer. "In addition, we achieved higher milestone-related revenues in the quarter driven by partner clinical trial progress. Based on the improved outlook for royalties and greater visibility on anticipated milestone revenues, we are increasing our full year 2020 financial guidance. Recent new product launches and partner development progress position Halozyme to deliver continued strong growth. Our strong growth outlook supports our commitment to capital return, which has already resulted in $312.4 million worth of share repurchases under our three-year $550 million share repurchase program announced in November 2019."

    Third Quarter 2020 and Recent Highlights Include:

    • On October 22, argenx announced it is advancing development of efgartigimod SC with Halozyme's ENHANZE® technology for pemphigus (vulgaris and foliaceus), a group of autoimmune skin disorders. The global Phase 3 ADDRESS trial evaluating SC efgartigimod in up to 150 pemphigus patients is expected to initiate by end of 2020, and will result in a milestone payment to Halozyme. In addition, argenx announced it had initiated a Phase 1 healthy volunteer study of intravenous ARGX-117 and subcutaneous ARGX-117 utilizing ENHANZE® technology targeting complement C2. On October 6, the Company announced that argenx expanded its existing global collaboration and license agreement that was signed in February 2019. Under the newly announced expansion, argenx gained the ability to exclusively access Halozyme's ENHANZE® drug delivery technology for three additional targets upon nomination for a total of up to six targets. To date, argenx has nominated two targets including the human neonatal Fc receptor FcRn, which is blocked by efgartigimod, and complement component C2.
    • On September 17, the Company announced that Roche presented a poster with data from Part 1 of its Phase 1b study (IMscin001) evaluating atezolizumab (Tecentriq®) for subcutaneous administration utilizing Halozyme's ENHANZE® technology in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) at the European Society for Medical Oncology ("ESMO") Virtual Congress 2020. The poster concluded that atezolizumab utilizing Halozyme's ENHANZE® technology, provided similar exposure as atezolizumab IV and that results supported further development of subcutaneous atezolizumab in IMscin001 Part 2, a confirmatory phase III study. Initiation of the Tecentriq® Phase 3 study will result in a milestone payment to Halozyme.
    • On September 15, Takeda Pharmaceutical announced that the European Medicines Agency (EMA) approved a label update for HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] broadening its use and making it the first and only facilitated subcutaneous immunoglobulin replacement therapy in adults, adolescents and children with an expanded range of secondary immunodeficiencies (SID).
    • On September 10, the Company announced that Janssen submitted a supplemental BLA for FDA approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) to be approved for a new indication, light chain (AL) amyloidosis. The application is based on positive data from the phase 3 ANDROMEDA trial (NCT03201960). An estimated 30,000 to 45,000 people are living with AL amyloidosis in the U.S. and Europe, and an estimated 4,500 people develop the disease each year in the U.S. alone. There are currently no approved therapies for the disease.
    • In August 2020, Janssen announced that Health Canada approved DARZALEX® SC utilizing ENHANZE® technology (daratumumab) in four regimens across five indications in patients with multiple myeloma, most notably newly diagnosed, transplant ineligible patients as well as relapsed or refractory patients.
    • During the third quarter, the Company repurchased approximately 2.1 million shares of common stock for $58.9 million at an average price per share of $27.57, bringing the total for year-to-date open market share repurchases to $112.4 million at an average price of $20.76.

    Third Quarter 2020 Financial Highlights

    • Revenue for the third quarter was $65.3 million compared to $46.2 million for the third quarter of 2019. The year-over-year increase was primarily driven by $32.0 million in collaboration revenue from Roche and argenx in the current period. Revenue for the quarter included $23.9 million in royalties, an increase of 44% compared to $16.6 million in the prior year period.
    • Research and development expenses for the third quarter were $7.7 million, compared to $30.5 million for the third quarter of 2019. The decrease in expenses was due to a decrease in clinical trial activities-related costs as a result of the Company halting its oncology drug development efforts beginning in November 2019.
    • Selling, general and administrative expenses for the third quarter were $11.7 million, compared to $18.0 million for the third quarter of 2019. The decrease was due to lower compensation and commercial-related expenses related to the corporate restructuring announced in November 2019.
    • The Company reported its second consecutive quarter of what it expects will be sustainable profitability. Net income for the third quarter was $36.2 million, or $0.25 per share, compared to a net loss in the third quarter of 2019 of $25.0 million, or $0.17 per share.
    • Cash, cash equivalents and marketable securities were $346.7 million at September 30, 2020, compared to $421.3 million at December 31, 2019.

    Financial Outlook for 2020

    The Company continues to monitor the impact of the COVID-19 pandemic on its business and receives updates from its partners and suppliers on how their businesses are affected. Based on this information and Halozyme's planned expenditures for the year, the Company is raising full year 2020 financial guidance and now expects:

    • Revenues of $250 million to $260 million, increased from prior guidance of $230 million to $245 million, representing growth of 28 to 33% over prior year revenues;
    • Earnings per share on a GAAP basis of $0.80 to $0.85, increased from prior guidance of $0.60 to $0.75.

    Webcast and Conference Call

    Halozyme will webcast its Quarterly Update Conference Call for the third quarter of 2020 today, Monday, November 2, 2020 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme's corporate website and a replay will be available following the close of the call. To register for this conference call, please use this link: http://www.directeventreg.com/registration/event/7767139. After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of the call.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. 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 in this press release include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance (including the Company's financial outlook for 2020) and expectations for future growth, profitability, revenue, margins, expenses and earnings-per-share and the Company's plans to continue its share repurchase program. Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's ENHANZE®  business may include potential growth driven by our partners' development and commercialization efforts, the size and growth prospects of our partners' drug franchises, potential new ENHANZE® collaborations and collaborative targets and regulatory review and potential approvals of new ENHANZE® products. These 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 and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, inability to sustain profitability, unexpected delays in the execution of the Company's  share repurchase program, unexpected results or delays in the growth of the Company's ENHANZE® business, or in the development, regulatory review or commercialization of ENHANZE® products, including any potential delays caused by the current COVID-19 global pandemic, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-K filed with the Securities and Exchange Commission.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

     

    Halozyme Therapeutics, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per share amounts)







    Three Months Ended

     September 30,



    Nine Months Ended

    September 30,





    2020



    2019



    2020



    2019

    Revenues:

















    Royalties



    $

    23,931





    $

    16,609





    $

    56,599





    $

    52,669



    Product sales, net



    9,048





    29,205





    23,532





    43,355



    Revenues under collaborative agreements



    32,337





    416





    65,760





    46,303



    Total revenues



    65,316





    46,230





    145,891





    142,327



    Operating expenses:

















    Cost of product sales



    5,568





    22,333





    17,095





    28,859



    Research and development



    7,747





    30,455





    26,856





    95,693



    Selling, general and administrative



    11,702





    17,979





    35,309





    53,323



    Total operating expenses



    25,017





    70,767





    79,260





    177,875



    Operating income (loss)



    40,299





    (24,537)





    66,631





    (35,548)



    Other income (expense):

















    Investment and other income, net



    961





    1,613





    4,764





    5,653



    Interest expense



    (4,990)





    (2,078)





    (15,342)





    (7,896)



    Net income (loss) before income taxes



    36,270





    (25,002)





    56,053





    (37,791)



    Income tax expense



    63





    13





    132





    52



    Net income (loss)



    $

    36,207





    $

    (25,015)





    $

    55,921





    $

    (37,843)





















    Net income (loss) per share:

















    Basic



    $

    0.27





    $

    (0.17)





    $

    0.41





    $

    (0.26)



    Diluted



    $

    0.25





    $

    (0.17)





    $

    0.40





    $

    (0.26)





















    Shares used in computing net income (loss) per share:

















    Basic



    136,578





    146,136





    136,575





    145,435



    Diluted



    142,081





    146,136





    139,971





    145,435



     

    Halozyme Therapeutics, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited)

    (In thousands)







    September 30,

     2020



    December 31,

     2019

    ASSETS









    Current assets:









    Cash and cash equivalents



    $

    65,741





    $

    120,179



    Marketable securities, available-for-sale



    280,965





    301,083



    Accounts receivable, net and other contract assets



    62,551





    59,442



    Inventories



    57,697





    29,359



    Prepaid expenses and other assets



    31,941





    33,373



    Total current assets



    498,895





    543,436



    Property and equipment, net



    10,252





    10,855



    Prepaid expenses and other assets



    14,382





    11,083



    Restricted cash



    500





    500



    Total assets



    $

    524,029





    $

    565,874













    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









    Accounts payable



    $

    433





    $

    6,434



    Accrued expenses



    25,795





    55,649



    Deferred revenue, current portion



    748





    4,012



    Current portion of long-term debt, net







    19,542



    Total current liabilities



    26,976





    85,637













    Deferred revenue, net of current portion



    641





    1,247



    Long-term debt, net



    393,631





    383,045



    Other long-term liabilities



    3,793





    4,180













    Stockholders' equity:









    Common stock



    135





    137



    Additional paid-in capital



    646,184





    695,066



    Accumulated other comprehensive income (loss)



    426





    240



    Accumulated deficit



    (547,757)





    (603,678)



    Total stockholders' equity



    98,988





    91,765



    Total liabilities and stockholders' equity



    $

    524,029





    $

    565,874



     

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  18. SAN DIEGO, Oct. 22, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) will webcast its Quarterly Update Conference Call for the third quarter 2020 on Monday, November 2 at 4:30 p.m. ET / 1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the third quarter ended September 30, 2020, following the close of trading.

    To register for this conference call, please use this link: http://www.directeventreg.com/registration/event/7767139. After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected…

    SAN DIEGO, Oct. 22, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) will webcast its Quarterly Update Conference Call for the third quarter 2020 on Monday, November 2 at 4:30 p.m. ET / 1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the third quarter ended September 30, 2020, following the close of trading.

    To register for this conference call, please use this link: http://www.directeventreg.com/registration/event/7767139. After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of 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 the Investors page of www.halozyme.com approximately 15 minutes prior to the call to register, download and install any necessary audio software. A telephone replay will be available for two weeks after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 7767139.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

     

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  19. SAN DIEGO, Oct. 6, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Halozyme and argenx are expanding their existing global collaboration and license agreement that was signed in February 2019.

    Under the newly announced expansion, argenx gained the ability to exclusively access Halozyme's ENHANZE® drug delivery technology for three additional targets upon nomination for a total of up to six targets under the existing and newly expanded collaboration.  To date, argenx has nominated two targets including the human neonatal Fc receptor FcRn and complement component C2.

    "We are pleased to be expanding the scope of our collaboration with Halozyme and to continue our productive relationship. We recognize that patients…

    SAN DIEGO, Oct. 6, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Halozyme and argenx are expanding their existing global collaboration and license agreement that was signed in February 2019.

    Under the newly announced expansion, argenx gained the ability to exclusively access Halozyme's ENHANZE® drug delivery technology for three additional targets upon nomination for a total of up to six targets under the existing and newly expanded collaboration.  To date, argenx has nominated two targets including the human neonatal Fc receptor FcRn and complement component C2.

    "We are pleased to be expanding the scope of our collaboration with Halozyme and to continue our productive relationship. We recognize that patients have different preferences and we want to secure our ability to offer subcutaneous delivery of our current and future candidates to reach as many patients as possible. We already have exclusive access to ENHANZE® for our FcRn antagonist efgartigimod, which is in late stage development for multiple severe autoimmune diseases, and additionally have nominated our complement inhibitor targeting C2," said Keith Woods, Chief Operating Officer of argenx.

    "We are delighted that argenx has agreed to expand our global collaboration and license agreement to include up to six targets," said Dr. Helen Torley, president and chief executive officer. "argenx has made rapid progress in the clinic with efgartigimod utilizing ENHANZE® since signing the original agreement, moving to a Phase 2 study initiation for an indication being developed only as SC, within just fourteen months. argenx is also working to bring SC efgartigimod to patients suffering from myasthenia gravis following the successful ADAPT trial results."

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. 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, the product development and approval efforts of Halozyme's ENHANZE® partners, including the potential to nominate additional targets under an existing collaboration agreement, and statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and lowering the treatment burden for patients. These forward-looking statements involve risks 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 uncertainties concerning whether the expansion of the collaboration agreement referred to in this press release ultimately results in the nomination of additional targets or the development, approval or commercialization of additional collaboration products, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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  20. SAN DIEGO, Sept. 17, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that its collaborator, Roche, presented a poster with data from Part 1 of its Phase 1b study (IMscin001) evaluating atezolizumab (Tecentriq®) for subcutaneous administration utilizing Halozyme's ENHANZE® technology in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) at the ESMO Virtual Congress 2020.

    The Phase 1b dose-finding study enrolled 67 patients with advanced/metastatic NSCLC previously treated with chemotherapy (no prior cancer immunotherapy) in 3 cohorts.  The poster concluded that atezolizumab utilizing ENHANZE® was well tolerated, provided similar exposure as atezolizumab IV and that results support…

    SAN DIEGO, Sept. 17, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that its collaborator, Roche, presented a poster with data from Part 1 of its Phase 1b study (IMscin001) evaluating atezolizumab (Tecentriq®) for subcutaneous administration utilizing Halozyme's ENHANZE® technology in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) at the ESMO Virtual Congress 2020.

    The Phase 1b dose-finding study enrolled 67 patients with advanced/metastatic NSCLC previously treated with chemotherapy (no prior cancer immunotherapy) in 3 cohorts.  The poster concluded that atezolizumab utilizing ENHANZE® was well tolerated, provided similar exposure as atezolizumab IV and that results support further development of subcutaneous atezolizumab in IMscin001 Part 2, a confirmatory phase III study.

    "We are pleased that the results from Roche's Phase 1b evaluating atezolizumab with ENHANZE® support continued development in a Phase 3 study," said Dr. Helen Torley, president and chief executive officer.

    The subcutaneous formulation of atezolizumab is being developed to potentially allow faster administration via subcutaneous injection under the skin, compared to the original intravenous (IV) formulation, thereby significantly reducing a patient's time spent receiving treatment.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. 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, the product development and approval efforts of Halozyme's ENHANZE® partners, including the potential continued evaluation of atezolizumab with ENHANZE® in a Phase 3 clinical study, and statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and lowering the treatment burden for patients. These forward-looking statements also include statements. These forward-looking statements involve risks 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 uncertainties concerning whether the collaborative product referred to in this press release is ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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  21. SAN DIEGO, Sept. 10, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that its collaborator Janssen Biotech, Inc. (Janssen) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab utilizing Halozyme's ENHANZE® technology, for the treatment of patients with light chain (AL) amyloidosis, a rare and potentially fatal disease for which there are no currently approved therapies1,2. The sBLA is supported by positive results from the Phase 3 ANDROMEDA study, which were presented as a late-breaking abstract at the 25th European Hematology Association…

    SAN DIEGO, Sept. 10, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that its collaborator Janssen Biotech, Inc. (Janssen) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab utilizing Halozyme's ENHANZE® technology, for the treatment of patients with light chain (AL) amyloidosis, a rare and potentially fatal disease for which there are no currently approved therapies1,2. The sBLA is supported by positive results from the Phase 3 ANDROMEDA study, which were presented as a late-breaking abstract at the 25th European Hematology Association Annual Congress in June 2020. Janssen's ANDROMEDA study evaluated subcutaneous daratumumab in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) compared to VCd alone and met its primary endpoint of overall hematologic complete response rate.

    "We are excited that DARZALEX FASPROTM utilizing our ENHANZE® technology has the potential to be approved in a new indication," said Dr. Helen Torley, president and chief executive officer. "Patients diagnosed with AL amyloidosis currently have no approved therapeutic options and we are therefore pleased that a new treatment for the disease may soon be available."

    The sBLA is being reviewed under the FDA Real-Time Oncology Review (RTOR) program, which allows data for certain applications to be reviewed before the applicant formally submits the complete application. The RTOR program aims to explore a more efficient review process to help ensure treatments are available as soon as possible for patients. Selection into the RTOR program does not guarantee or influence approvability of the supplemental application.

    The submission is also being reviewed under Project Orbis, an initiative of the FDA Oncology Center of Excellence, which provides a framework for concurrent submission and review of oncology medicine applications among international regulatory agencies.3

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. 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, the product development and approval efforts of Halozyme's ENHANZE® partners and statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery. These forward-looking statements also include statements regarding the FDA Real-Time Oncology Review program and the potential for a more efficient regulatory review process of the sBLA referenced in this press release. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review, unexpected regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    1 National Organization for Rare Disorders. Amyloidosis. Accessed August 20, 2020. https://rarediseases.org/rare-diseases/amyloidosis/.

    2 Lousada I, Comenzo RL, Landau H, et al. Light chain amyloidosis: patient experience survey from the Amyloidosis Research Consortium. Advances in Therapy. 2015;32(10):920-928.

    3  Project Orbis. U.S. Food and Drug Administration. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis. Accessed July 2020.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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  22. SAN DIEGO, Sept. 9, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will be participating in the following investor conferences:

    • Cantor Virtual Global Healthcare Conference at 10:40 a.m. ET / 7:40 a.m. PT on Tuesday, September 15, 2020
    • Morgan Stanley Virtual Global Healthcare Conference at 2:00 p.m. ET / 11:00 a.m. PT on Thursday, September 17, 2020

    A live webcast of each event can be accessed through the "Investors" section of Halozyme's website (www.halozyme.com), and an archive will be made available for 90 days following each event. To access a live webcast, please visit Halozyme's website (www.halozyme.com) approximately 15 minutes prior to the presentation…

    SAN DIEGO, Sept. 9, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will be participating in the following investor conferences:

    • Cantor Virtual Global Healthcare Conference at 10:40 a.m. ET / 7:40 a.m. PT on Tuesday, September 15, 2020
    • Morgan Stanley Virtual Global Healthcare Conference at 2:00 p.m. ET / 11:00 a.m. PT on Thursday, September 17, 2020

    A live webcast of each event can be accessed through the "Investors" section of Halozyme's website (www.halozyme.com), and an archive will be made available for 90 days following each event. To access a live webcast, please visit Halozyme's website (www.halozyme.com) approximately 15 minutes prior to the presentation to register and download any necessary audio software.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via three commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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  23. SAN DIEGO, Sept. 2, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will participate in the upcoming 2020 Wells Fargo Virtual Healthcare Conference. Dr. Torley will take part in a fireside chat at 10:00 a.m. ET / 07:00 a.m. PT on Wednesday, September 9, 2020.

    A live webcast of the event can be accessed through the "Investors" section of Halozyme's website (www.halozyme.com), and an archive will be made available for 90 days following the event. To access a live webcast, please visit Halozyme's website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

    About Halozyme

    Halozyme is a biopharmaceutical…

    SAN DIEGO, Sept. 2, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will participate in the upcoming 2020 Wells Fargo Virtual Healthcare Conference. Dr. Torley will take part in a fireside chat at 10:00 a.m. ET / 07:00 a.m. PT on Wednesday, September 9, 2020.

    A live webcast of the event can be accessed through the "Investors" section of Halozyme's website (www.halozyme.com), and an archive will be made available for 90 days following the event. To access a live webcast, please visit Halozyme's website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary recombinant human hyaluronidase enzyme rHuPH20 forms the basis of the ENHANZE® drug delivery technology and is used to facilitate the subcutaneous delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® drug delivery technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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  24. SAN DIEGO, Aug. 10, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today reported financial results for the second quarter ended June 30, 2020 and provided an update on its recent corporate activities and outlook.

    "The second quarter marked the achievement of multiple key milestones for Halozyme including two FDA approvals and one EMA approval for partnered drugs bringing the total number of FDA-approved products utilizing our ENHANZE® drug delivery technology to five," said Dr. Helen Torley, president and chief executive officer. "In addition, we are delighted to report that in the second quarter we delivered our first profitable quarter of expected sustainable profitability with earnings per share of $0.19. We see this as an…

    SAN DIEGO, Aug. 10, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today reported financial results for the second quarter ended June 30, 2020 and provided an update on its recent corporate activities and outlook.

    "The second quarter marked the achievement of multiple key milestones for Halozyme including two FDA approvals and one EMA approval for partnered drugs bringing the total number of FDA-approved products utilizing our ENHANZE® drug delivery technology to five," said Dr. Helen Torley, president and chief executive officer. "In addition, we are delighted to report that in the second quarter we delivered our first profitable quarter of expected sustainable profitability with earnings per share of $0.19. We see this as an important first step in our transformation to a high growth, high margin business delivering sustainable revenue growth and profitability over the long term. The events of the quarter were highlighted by our partner Janssen receiving approvals in both the U.S. and the EU for the subcutaneous form of DARZALEX® utilizing ENHANZE®, which is branded as DARZALEX FASPROTM in the U.S. We earned $25 million in total milestone payments from Janssen during the quarter, upon the first commercial sales in both markets. In late June, our partner Roche received FDA approval for Phesgo™, a fixed-dose combination of two monoclonal antibodies, Perjeta® and Herceptin®, utilizing our ENHANZE® technology for the treatment of patients with HER2-positive breast cancer. In addition to providing important new treatment options for patients, each of these newly-approved drugs represents the subcutaneous form of a growing, blockbuster franchise, and we expect their adoption to be an important driver of our growth and profitability in the coming years."

    "I want to again express my gratitude to the Halozyme team, our partners and suppliers for their tireless work as we all navigate challenges posed by the COVID-19 pandemic," continued Dr. Torley. "Based on the latest information from our partners, I am pleased to report that we are maintaining our financial outlook for the full year 2020.  It is possible that our partners' timelines may change as a result of future changes related to COVID-19. We will continue to monitor this closely and provide updates as appropriate."

    Second Quarter 2020 and Recent Highlights Include:

    • On June 29, the Company announced that Roche received FDA approval for Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf), a fixed-dose combination of Perjeta® and Herceptin® for subcutaneous injection utilizing ENHANZE® technology for the treatment of patients with HER2-positive breast cancer. Phesgo™ can be administered in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose. This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta® and Herceptin® using the standard intravenous (IV) formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines. Phesgo™ can be administered by a healthcare professional in a treatment center or at a patient's home.
    • On June 13, the Company announced that findings from Janssen's phase 3 ANDROMEDA (AMY3001) study evaluating subcutaneous daratumumab utilizing ENHANZE® in light-chain Amyloidosis were presented at the European Hematology Association 25th Annual Congress. Janssen reported that the study met the primary endpoint of percentage of patients with hematologic complete response.
    • On June 4, the Company announced that Janssen received European marketing authorization for the subcutaneous formulation of DARZALEX® (daratumumab) utilizing ENHANZE® for the treatment of adult patients with multiple myeloma in all currently approved DARZALEX® intravenous (IV) formulation indications in frontline and relapsed / refractory settings. Subsequent launch of the product and first commercial sale in Europe resulted in a $10 million milestone payment in the quarter.
    • In June 2020, Bristol Myers Squibb initiated a Phase 1/2 study of ipilimumab in combination with nivolumab in multiple tumor types utilizing ENHANZE® technology.
    • On May 1, the Company announced that Janssen received U.S. FDA approval of DARZALEX FASPROTM (daratumumab hyaluronidase human- fihj) in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients. As a fixed-dose formulation, DARZALEX FASPROTM can be administered subcutaneously over three to five minutes, significantly less time than IV DARZALEX®, which requires multi-hour infusions. Subsequent launch of the product and first commercial sale resulted in a $15 million milestone in the quarter.

    Second Quarter 2020 Financial Highlights

    • Revenue for the second quarter was $55.2 million compared to $39.1 million for the second quarter of 2019. The year-over-year increase was primarily driven by $32.3 million in collaboration payments from Janssen and Bristol Myers Squibb in the current period. Revenue for the quarter included $15.8 million in royalties, which compared to $18.1 million in the prior year period.
    • Research and development expenses for the second quarter were $9.0 million, compared to $33.9 million for the second quarter of 2019. The decrease in expenses was due to a decrease in clinical trial activities-related costs as a result of the Company halting its oncology drug development efforts in November 2019.
    • Selling, general and administrative expenses for the second quarter were $11.0 million, compared to $17.3 million for the second quarter of 2019. The decrease was due to lower compensation and commercial-related expenses related to the corporate restructuring announced in November 2019.
    • The Company reported the first quarter of what it expects will be sustainable profitability. Net income for the second quarter was $25.8 million, or $0.19 per share, compared to a net loss in the second quarter of 2019 of $14.6 million, or $0.10 per share.
    • Cash, cash equivalents and marketable securities were $385.4 million at June 30, 2020, compared to $421.3 million at December 31, 2019.

    Financial Outlook for 2020

    The Company continues to monitor the impact of the COVID-19 pandemic on its business and receives updates from its partners and suppliers on how their businesses are affected. Based on this information and Halozyme's planned expenditures for the year, the Company's 2020 financial guidance remains unchanged. For 2020 Halozyme continues to expect:

    • Revenues of $230 million to $245 million, representing growth of 17% to 25%;
    • Earnings per share on a GAAP basis of $0.60 to $0.75.

    The Company remains committed to capital return and plans to repurchase an additional number of shares, up to an additional $96 million worth, during the remainder of 2020. The amount and timing of shares repurchased during 2020 will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements.

    Webcast and Conference Call

    Halozyme will webcast its Quarterly Update Conference Call for the second quarter of 2020 today, Monday, August 10, 2020 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme's corporate website and a replay will be available following the close of the call. To register for this conference call, please use this link: http://www.directeventreg.com/registration/event/6277618. To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. A telephone replay will be available for two weeks after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 6277618.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. 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 in this press release include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance (including the Company's financial outlook for 2020) and expectations for future growth, profitability, revenue, margins, expenses and earnings-per-share and the Company's plans to continue its share repurchase program.  Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's ENHANZE®  business may include potential growth driven by our partners' development and commercialization efforts, the size and growth prospects of our partners' drug franchises, potential new ENHANZE® collaborations and collaborative targets and regulatory review and potential approvals of new ENHANZE® products. These 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 and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, inability to sustain profitability, unexpected delays in the execution of the Company's  share repurchase program, unexpected results or delays in the growth of the Company's ENHANZE® business, or in the development, regulatory review or commercialization of ENHANZE® products, including any potential delays caused by the current COVID-19 global pandemic, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-K filed with the Securities and Exchange Commission.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per share amounts)







    Three Months Ended 

     June 30,



    Six Months Ended





    2020



    2019



    2020



    2019

    Revenues:

















    Royalties



    $

    15,846





    $

    18,107





    $

    32,668





    $

    36,060



    Product sales, net



    6,337





    5,760





    14,484





    14,150



    Revenues under collaborative agreements



    33,038





    15,281





    33,423





    45,887



    Total revenues



    55,221





    39,148





    80,575





    96,097



    Operating expenses:

















    Cost of product sales



    5,740





    1,877





    11,527





    6,526



    Research and development



    8,951





    33,910





    19,109





    65,238



    Selling, general and administrative



    10,975





    17,338





    23,607





    35,344



    Total operating expenses



    25,666





    53,125





    54,243





    107,108



    Operating income (loss)



    29,555





    (13,977)





    26,332





    (11,011)



    Other income (expense):

















    Investment and other income, net



    1,324





    1,983





    3,803





    4,040



    Interest expense



    (5,004)





    (2,613)





    (10,352)





    (5,818)



    Net income (loss) before income taxes



    25,875





    (14,607)





    19,783





    (12,789)



    Income tax expense



    58





    17





    69





    39



    Net income (loss)



    $

    25,817





    $

    (14,624)





    $

    19,714





    $

    (12,828)





















    Net income (loss) per share:

















    Basic



    $

    0.19





    $

    (0.10)





    $

    0.14





    $

    (0.09)



    Diluted



    $

    0.19





    $

    (0.10)





    $

    0.14





    $

    (0.09)





















    Shares used in computing net income (loss) per share:

















    Basic



    135,935





    145,411





    136,572





    145,051



    Diluted



    138,084





    145,411





    138,837





    145,051



     

    Halozyme Therapeutics, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited)

    (In thousands)







    June 30, 

     2020



    December 31, 

     2019

    ASSETS









    Current assets:









    Cash and cash equivalents



    $

    133,606





    $

    120,179



    Marketable securities, available-for-sale



    251,840





    301,083



    Accounts receivable, net



    37,401





    59,442



    Inventories



    48,271





    29,359



    Prepaid expenses and other assets



    29,240





    33,373



    Total current assets



    500,358





    543,436



    Property and equipment, net



    11,169





    10,855



    Prepaid expenses and other assets



    14,970





    11,083



    Restricted cash



    500





    500



    Total assets



    $

    526,997





    $

    565,874













    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









    Accounts payable



    $

    4,067





    $

    6,434



    Accrued expenses



    21,258





    55,649



    Deferred revenue, current portion



    748





    4,012



    Current portion of long-term debt, net







    19,542



    Total current liabilities



    26,073





    85,637













    Deferred revenue, net of current portion



    641





    1,247



    Long-term debt, net



    390,079





    383,045



    Other long-term liabilities



    4,627





    4,180













    Stockholders' equity:









    Common stock



    137





    137



    Additional paid-in capital



    688,318





    695,066



    Accumulated other comprehensive income (loss)



    1,086





    240



    Accumulated deficit



    (583,964)





    (603,678)



    Total stockholders' equity



    105,577





    91,765



    Total liabilities and stockholders' equity



    $

    526,997





    $

    565,874



     

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  25. SAN DIEGO, Aug. 4, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will participate in the upcoming Canaccord Genuity 40th Annual Growth Conference. Dr. Torley will take part in a fireside chat at 8:30 a.m. ET / 05:30 a.m. PT on Wednesday, August 12, 2020.

    A live webcast of the event can be accessed through the "Investors" section of Halozyme's website (www.halozyme.com), and an archive will be made available for 90 days following the event. To access a live webcast, please visit Halozyme's website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

    About Halozyme

    Halozyme is a biopharmaceutical…

    SAN DIEGO, Aug. 4, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will participate in the upcoming Canaccord Genuity 40th Annual Growth Conference. Dr. Torley will take part in a fireside chat at 8:30 a.m. ET / 05:30 a.m. PT on Wednesday, August 12, 2020.

    A live webcast of the event can be accessed through the "Investors" section of Halozyme's website (www.halozyme.com), and an archive will be made available for 90 days following the event. To access a live webcast, please visit Halozyme's website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary recombinant human hyaluronidase enzyme rHuPH20 forms the basis of the ENHANZE® drug delivery technology and is used to facilitate the subcutaneous delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® drug delivery technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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  26. SAN DIEGO, July 29, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) will webcast its Quarterly Update Conference Call for the second quarter 2020 on Monday, August 10 at 4:30 p.m. ET / 1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the second quarter ended June 30, 2020, following the close of trading.

    To register for this conference call, please use this link: http://www.directeventreg.com/registration/event/6277618. After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected…

    SAN DIEGO, July 29, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) will webcast its Quarterly Update Conference Call for the second quarter 2020 on Monday, August 10 at 4:30 p.m. ET / 1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the second quarter ended June 30, 2020, following the close of trading.

    To register for this conference call, please use this link: http://www.directeventreg.com/registration/event/6277618. After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call. However, to ensure you are connected for the full call, we suggest registering a day in advance or at minimum 10 minutes before the start of 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 the Investors page of www.halozyme.com approximately 15 minutes prior to the call to register, download and install any necessary audio software. A telephone replay will be available for two weeks after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 6277618.

    About Halozyme

    Halozyme Therapeutics, Inc. is a biopharma technology platform company that provides innovative and disruptive solutions with the goal of improving patient experience and outcomes. Our proprietary enzyme rHuPH20 is used to facilitate the delivery of injected drugs and fluids. We license our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug delivery technology with the collaborators' proprietary compounds. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

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  27. SAN DIEGO, June 29, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the U.S. Food and Drug Administration (FDA) has approved Roche's Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, a fixed-dose combination (FDC) of Perjeta® and Herceptin® with Halozyme's ENHANZE® technology, administered subcutaneously in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with early and metastatic HER2-positive breast cancer. This is the first time a product has been approved combining two monoclonal antibodies that can be administered by a single subcutaneous injection utilizing Halozyme's ENHANZE® technology.

    "We are excited that HER2-positive breast cancer patients…

    SAN DIEGO, June 29, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the U.S. Food and Drug Administration (FDA) has approved Roche's Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf) injection, a fixed-dose combination (FDC) of Perjeta® and Herceptin® with Halozyme's ENHANZE® technology, administered subcutaneously in combination with intravenous (IV) chemotherapy, for the treatment of eligible patients with early and metastatic HER2-positive breast cancer. This is the first time a product has been approved combining two monoclonal antibodies that can be administered by a single subcutaneous injection utilizing Halozyme's ENHANZE® technology.

    "We are excited that HER2-positive breast cancer patients in the U.S. will now have the option to receive this important therapy in a meaningfully shorter period of time," said Dr. Helen Torley, president and chief executive officer. "This subcutaneous delivery was shown to be preferred to IV administration by 85% of patients in the PHranceSCa study due to less time in the clinic and more comfortable treatment administration. Phesgo is the second product to receive FDA approval this year, and the first demonstrating the ability to combine two monoclonal antibodies, utilizing our ENHANZE® technology."

    Phesgo is available in single-dose vials and can be administered in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent maintenance dose.(1) This is compared to approximately 150 minutes for a sequential infusion of a loading dose of Perjeta® and Herceptin® using the standard IV formulations, and between 60-150 minutes for subsequent maintenance infusions of the two medicines.(2,3) Phesgo can be administered by a healthcare professional in a treatment center or at a patient's home.

    The approval is based on results from the pivotal phase III FeDeriCa study, which met its primary endpoint, with Phesgo showing non-inferior levels of Perjeta® in the blood during a given dosing interval (Ctrough), when compared to IV administration of Perjeta®. The safety profile of Phesgo with chemotherapy was comparable to IV administration of Perjeta® plus Herceptin® and chemotherapy, and no new safety signals were identified, including no meaningful difference in cardiac toxicity. The most common adverse events in both arms were alopecia, nausea, diarrhea and anemia.(1,4)

    The phase II PHranceSCa study showed that 85% (136/160) of people receiving treatment for HER2-positive breast cancer preferred treatment under the skin to IV administration due to less time in the clinic and more comfortable treatment administration.(1)

    About ENHANZE® Technology 

    Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via four commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Halozyme Safe Harbor Statement

    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes from being treated with the newly-approved ENHANZE® co-formulated product referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    References:

    (1) US Food and Drug Administration. Prescribing information for Phesgo.

    (2) US Food and Drug Administration. Prescribing Information for Herceptin. [Internet; cited June 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf.

    (3) US Food and Drug Administration. Prescribing Information for Perjeta [Internet; cited June 2020]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf

    (4) Tan A, et al. Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study. Presented at SABCS, 2019 Dec 10-14; San Antonio, Texas. Abstract #PD4-07.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

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  28. SAN DIEGO, June 22, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced  the company will receive a $10 million milestone payment from Janssen Biotech, Inc. (Janssen) triggered under the Collaboration and License Agreement between the two companies. The milestone payment is associated with the first commercial sale in the European Union of Janssen's subcutaneous formulation of DARZALEX® (daratumumab) utilizing ENHANZE®, which was recently granted marketing authorization by the European Commission.

    About Halozyme
    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical…

    SAN DIEGO, June 22, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced  the company will receive a $10 million milestone payment from Janssen Biotech, Inc. (Janssen) triggered under the Collaboration and License Agreement between the two companies. The milestone payment is associated with the first commercial sale in the European Union of Janssen's subcutaneous formulation of DARZALEX® (daratumumab) utilizing ENHANZE®, which was recently granted marketing authorization by the European Commission.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via four commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com

    Halozyme Safe Harbor Statement

    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the receipt of a future milestone payment, the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected delays in the receipt of the milestone payment referred to in this press release, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

     

     

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

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  29. SAN DIEGO, June 17, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will be participating in the upcoming BMO 2020 Prescriptions for Success Healthcare Conference, which is being held as a virtual event. Dr. Torley will participate in a fireside chat at 3:00 p.m. ET / 12:00 p.m. PT on Tuesday, June 23, 2020.

    A live webcast of each event can be accessed through the "Investors" section of Halozyme's website (www.halozyme.com), and an archive will be made available for 90 days following each event. To access a live webcast, please visit Halozyme's website approximately 15 minutes prior to the presentation to register and download any necessary audio software…

    SAN DIEGO, June 17, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will be participating in the upcoming BMO 2020 Prescriptions for Success Healthcare Conference, which is being held as a virtual event. Dr. Torley will participate in a fireside chat at 3:00 p.m. ET / 12:00 p.m. PT on Tuesday, June 23, 2020.

    A live webcast of each event can be accessed through the "Investors" section of Halozyme's website (www.halozyme.com), and an archive will be made available for 90 days following each event. To access a live webcast, please visit Halozyme's website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via four commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

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  30. SAN DIEGO, June 13, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced  that Janssen Research & Development, LLC (Janssen) presented data from its Phase III ANDROMEDA (AMY3001) study of subcutaneous (SC) daratumumab utilizing ENHANZE® in combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD) for patients with newly diagnosed light-chain (AL) amyloidosis at the 25th Annual Congress of the European Hematology Association. Janssen reported that the study met the primary endpoint of percentage of patients with hematologic complete response. Additional information can be accessed here.

    "We are excited that the subcutaneous formulation of daratumumab utilizing ENHANZE® has demonstrated positive results…

    SAN DIEGO, June 13, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced  that Janssen Research & Development, LLC (Janssen) presented data from its Phase III ANDROMEDA (AMY3001) study of subcutaneous (SC) daratumumab utilizing ENHANZE® in combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD) for patients with newly diagnosed light-chain (AL) amyloidosis at the 25th Annual Congress of the European Hematology Association. Janssen reported that the study met the primary endpoint of percentage of patients with hematologic complete response. Additional information can be accessed here.

    "We are excited that the subcutaneous formulation of daratumumab utilizing ENHANZE® has demonstrated positive results in a potentially new indication addressing an underserved population with limited treatment options," said Dr. Helen Torley.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via four commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary recombinant human hyaluronidase enzyme rHuPH20 forms the basis of the ENHANZE® drug delivery technology and is used to facilitate the subcutaneous delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® drug delivery technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Halozyme Safe Harbor Statement

    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

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  31. SAN DIEGO, June 4, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the European Commission (EC) has granted Janssen-Cilag International NV (Janssen) marketing authorization for the subcutaneous (SC) formulation of DARZALEX® (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved DARZALEX® intravenous (IV) formulation indications in frontline and relapsed / refractory settings. The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV DARZALEX®, which is given over several hours. Patients currently…

    SAN DIEGO, June 4, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the European Commission (EC) has granted Janssen-Cilag International NV (Janssen) marketing authorization for the subcutaneous (SC) formulation of DARZALEX® (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved DARZALEX® intravenous (IV) formulation indications in frontline and relapsed / refractory settings. The approval follows a Positive Opinion by the CHMP of the European Medicines Agency (EMA) in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV DARZALEX®, which is given over several hours. Patients currently on IV DARZALEX® will have the choice to switch to the SC formulation.

    "We are delighted that the subcutaneous formulation of DARZALEX® has been granted marketing authorization in the EU with a broad label so soon after the CHMP positive opinion," said Dr. Helen Torley. "DARZALEX® SC has the potential to improve the treatment experience for multiple myeloma patients and physicians in the European Union as patients may benefit from a shorter treatment time when compared with a multi-hour intravenous infusion."

    The approval was based on data from two studies: the Phase III non-inferiority COLUMBA (MMY3012) study, which compared the SC formulation of daratumumab to the IV formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which evaluated SC daratumumab in combination with certain standard multiple myeloma regimens. The topline results from the COLUMBA study were announced in February 2019 and subsequently presented in oral sessions at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and the 24th European Hematology Association (EHA) Annual Congress. Updated data of the COLUMBA and the PLEIADES studies were presented during poster sessions at the 61st American Society of Hematology (ASH) Annual Meeting in December 2019.

    About ENHANZE® Technology 
    Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

    About Halozyme
    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via four commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Halozyme Safe Harbor Statement
    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes from being treated with the newly-approved ENHANZE® co-formulated product referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    Contact:
    Al Kildani
    Vice President, Investor Relations and Corporate Communications
    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

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  32. SAN DIEGO, May 28, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will be participating in the following investor conferences:

    • Jefferies Virtual Healthcare Conference at 10:00 a.m. ET / 7:00 a.m. PT on Thursday, June 4, 2020
    • Goldman Sachs 41st Annual Healthcare Conference at 4:40 p.m. ET / 1:40 p.m. PT on Wednesday, June 10, 2020

    A live webcast of each event can be accessed through the "Investors" section of Halozyme's website (www.halozyme.com), and an archive will be made available for 90 days following each event. To access a live webcast, please visit Halozyme's website approximately 15 minutes prior to the presentation to register and download…

    SAN DIEGO, May 28, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will be participating in the following investor conferences:

    • Jefferies Virtual Healthcare Conference at 10:00 a.m. ET / 7:00 a.m. PT on Thursday, June 4, 2020
    • Goldman Sachs 41st Annual Healthcare Conference at 4:40 p.m. ET / 1:40 p.m. PT on Wednesday, June 10, 2020

    A live webcast of each event can be accessed through the "Investors" section of Halozyme's website (www.halozyme.com), and an archive will be made available for 90 days following each event. To access a live webcast, please visit Halozyme's website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via three commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Contact:
    Al Kildani
    Vice President, Investor Relations and Corporate Communications
    858-704-8122

     

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  33. SAN DIEGO, May, 14, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced  the company will receive a $15 million milestone payment from Janssen Biotech, Inc. (Janssen) triggered under the Collaboration and License Agreement between the two companies. The milestone payment is associated with the first commercial sale in the United States of Janssen's DARZALEX FASPROTM (daratumumab and hyaluronidase - fihj) utilizing ENHANZE®, which was recently approved by the U.S. Food and Drug Administration.

    About Halozyme
    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical…

    SAN DIEGO, May, 14, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced  the company will receive a $15 million milestone payment from Janssen Biotech, Inc. (Janssen) triggered under the Collaboration and License Agreement between the two companies. The milestone payment is associated with the first commercial sale in the United States of Janssen's DARZALEX FASPROTM (daratumumab and hyaluronidase - fihj) utilizing ENHANZE®, which was recently approved by the U.S. Food and Drug Administration.

    About Halozyme
    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via three commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Halozyme Safe Harbor Statement
    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the receipt of a future milestone payment, the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected delays in the receipt of the milestone payment referred to in this press release, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release

    Contact:
    Al Kildani
    Vice President, Investor Relations and Corporate Communications
    858-704-8122

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  34. SAN DIEGO, May 11, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today reported financial results for the first quarter ended March 31, 2020 and provided an update on its recent corporate activities and outlook.

    "This has been a very exciting start to the year for Halozyme as we have achieved multiple value-creating events in our ENHANZE® business, including U.S. FDA approval for DARZALEX FASPROTM  with a broad set of label indications, and the receipt of a positive CHMP opinion in the EU, also recommending a broad set of label indications. The positive CHMP opinion is typically a precursor to marketing clearance," said Dr. Helen Torley, president and chief executive officer. "As we look ahead, we are excited about the launches…

    SAN DIEGO, May 11, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today reported financial results for the first quarter ended March 31, 2020 and provided an update on its recent corporate activities and outlook.

    "This has been a very exciting start to the year for Halozyme as we have achieved multiple value-creating events in our ENHANZE® business, including U.S. FDA approval for DARZALEX FASPROTM  with a broad set of label indications, and the receipt of a positive CHMP opinion in the EU, also recommending a broad set of label indications. The positive CHMP opinion is typically a precursor to marketing clearance," said Dr. Helen Torley, president and chief executive officer. "As we look ahead, we are excited about the launches of subcutaneous DARZALEX® in the U.S. and E.U. as well as the potential FDA approval of the subcutaneous fixed-dose combination of Perjeta® and Herceptin® later this year, and what they may mean for patients."

    "I want to express my gratitude to the Halozyme team, our partners and suppliers for our continued progress in spite of the challenges posed by COVID-19," continued Dr. Torley. "In light of these challenges, it is obviously difficult to predict how the pandemic recovery will unfold in the coming quarters. However, based on the latest information from our partners and suppliers, and our team's commitment to maintaining a lean operating structure, we feel confident maintaining our 2020 financial guidance at this time."

    First Quarter 2020 and Recent Highlights Include:

    • On May 1, the Company announced that The Janssen Pharmaceutical Companies of Johnson and Johnson received U.S. FDA approval of DARZALEX FASPROTM in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients. As a fixed-dose formulation, DARZALEX FASPROTM can be administered subcutaneously over three to five minutes, significantly less time than IV DARZALEX which requires multi-hour infusions.
    • On April 30, the Company announced that Janssen-Cilag International NV (Janssen) received a Committee for Medicinal Products for Human Use (CHMP) Positive Opinion from the European Medicines Agency (EMA) recommending approval of a DARZALEX® (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma in frontline and relapsed/refractory settings. The CHMP's Positive Opinion for daratumumab SC formulation applies to multiple current daratumumab indications including newly diagnosed and transplant-ineligible patients, as well as relapsed or refractory patients.
    • In April, the Company announced the submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) by Janssen Pharmaceutical K.K. (Janssen) seeking approval of a new subcutaneous (SC) formulation of daratumumab, an intravenous (IV) treatment approved for patients with multiple myeloma.
    • During the first quarter, the Company repurchased 3.2 million shares of its common stock at a weighted average price of $16.15 per share. These repurchased shares were in addition to shares repurchased as part of an Accelerated Share Repurchase plan that was completed in mid-February. To date the Company has repurchased over $250 million in shares as part of its three-year share repurchase authorization of up to $550 million approved by the Board in November 2019.
    • In February, the Company announced that the FDA has accepted a Biologics License Application (BLA) from Genentech, a member of the Roche Group, for the fixed-dose combination of pertuzumab (Perjeta®) and trastuzumab (Herceptin® ) for subcutaneous administration using ENHANZE® technology in combination with IV chemotherapy for the treatment of eligible patients with HER2-positive breast cancer, with an action date of October 18, 2020.

    First Quarter 2020 Financial Highlights

    • Revenue for the first quarter was $25.4 million compared to $56.9 million for the first quarter of 2019. The year-over-year decrease was primarily driven by a $30 million upfront payment from argenx in the prior year period. Revenue for the quarter included $16.8 million in royalties, which compared to $18.0 million in the prior year period.
    • Research and development expenses for the first quarter were $10.2 million, compared to $31.3 million for the first quarter of 2019. The decrease in expenses was due to a decrease in clinical trial activities-related costs as a result of the Company halting its oncology drug development efforts and related restructuring as announced in November 2019.
    • Selling, general and administrative expenses for the first quarter were $12.6 million, compared to $18.0 million for the first quarter of 2019. The decrease was due to lower compensation and commercial-related expenses related to the corporate restructuring announced in November 2019.
    • Net loss for the first quarter was $6.1 million, or $0.04 per share, compared to a net income in the first quarter of 2019 of $1.8 million, or $0.01 per share.
    • Cash, cash equivalents and marketable securities were $368.2 million at March 31, 2020, compared to $421.3 million at December 31, 2019.

    Financial Outlook for 2020

    The Company continues to monitor the impact of the COVID-19 pandemic on its business and receive updates from its partners and suppliers on how their businesses are affected. Based on this information and Halozyme's planned expenditures for the year, the Company's 2020 financial guidance remains unchanged from that first provided on January 14, 2020. For 2020 Halozyme continues to expect:

    • Revenues of $230 million to $245 million, representing growth of 17% to 25%;
    • Earnings per share on a GAAP basis of $0.60 to $0.75 with the first quarter of sustainable profitability beginning in Q2 2020.

    The guidance on earnings per share does not reflect any potential impact from the Company's plans to repurchase any additional number of shares, up to an additional $98 million worth, during the remainder of 2020. The amount and timing of shares repurchased during 2020 will be subject to a variety of factors including market conditions, other business considerations and applicable legal requirements.

    Webcast and Conference Call

    Halozyme will webcast its Quarterly Update Conference Call for the first quarter of 2020 today, Monday, May 11, 2020 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme's corporate website and a replay will be available following the close of the call. To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (833) 968-2181 (domestic callers) or (825) 312-2108 (international callers). A telephone replay will be available after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 3199114.

    About Halozyme

    Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients' lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially-validated solution has positively impacted more than 400,000 patient lives via three commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme's proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company's partners make progress developing and commercializing their products being developed with ENHANZE®. 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 in this press release include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance (including the Company's financial outlook for 2020) and expectations for profitability, revenue, expenses and earnings-per-share and the Company's plans to continue its share repurchase program.  Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's ENHANZE® business may include potential growth driven by our partners' development and commercialization efforts, potential new ENHANZE® collaborations and collaborative targets and regulatory review and potential approvals of new ENHANZE® products. These 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 and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected delays in the execution of the Company's share repurchase program, unexpected results or delays in the growth of the Company's ENHANZE® business, or in the development, regulatory review or commercialization of ENHANZE® products, including any potential delays caused by the current COVID-19 global pandemic, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-K filed with the Securities and Exchange Commission.

    Contact:
    Al Kildani
    Vice President, Investor Relations and Corporate Communications
    858-704-8122

     

    Halozyme Therapeutics, Inc

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per share amounts)




    Three Months Ended
    March 31,



    2020


    2019

    Revenues:





    Royalties


    $

    16,822



    $

    17,953


    Product sales, net


    8,147



    8,390


    Revenues under collaborative agreements


    385



    30,606


    Total revenues


    25,354



    56,949


    Operating expenses:





    Cost of product sales


    5,787



    4,649


    Research and development


    10,158



    31,328


    Selling, general and administrative


    12,632



    18,006


    Total operating expenses


    28,577



    53,983


    Operating (loss) income


    (3,223)



    2,966


    Other income (expense):





    Investment and other income, net


    2,479



    2,057


    Interest expense


    (5,348)



    (3,205)


    Net (loss) income before income taxes


    (6,092)



    1,818


    Income tax expense


    11



    22


    Net (loss) income


    $

    (6,103)



    $

    1,796







    Net (loss) income per share:





    Basic


    $

    (0.04)



    $

    0.01


    Diluted


    $

    (0.04)



    $

    0.01







    Shares used in computing net (loss) income per share:





    Basic


    137,186



    144,743


    Diluted


    137,186



    147,474


     

    Halozyme Therapeutics, Inc

    Condensed Consolidated Balance Sheets

    (Unaudited)

    (In thousands)




    March 31,
    2020


    December 31,
    2019

    ASSETS





    Current assets:





    Cash and cash equivalents


    $

    104,820



    $

    120,179


    Marketable securities, available-for-sale


    263,363



    301,083


    Accounts receivable, net


    29,749



    59,442


    Inventories


    41,452



    29,359


    Prepaid expenses and other assets


    28,587



    33,373


    Total current assets


    467,971



    543,436


    Property and equipment, net


    11,752



    10,855


    Prepaid expenses and other assets


    12,130



    11,083


    Restricted cash


    500



    500


    Total assets


    $

    492,353



    $

    565,874







    LIABILITIES AND STOCKHOLDERS' EQUITY





    Current liabilities:





    Accounts payable


    $

    8,320



    $

    6,434


    Accrued expenses


    26,811



    55,649


    Deferred revenue, current portion


    4,012



    4,012


    Current portion of long-term debt, net


    2,859



    19,542


    Total current liabilities


    42,002



    85,637







    Deferred revenue, net of current portion


    641



    1,247


    Long-term debt, net


    386,571



    383,045


    Other long-term liabilities


    5,097



    4,180







    Stockholders' equity:





    Common stock


    135



    137


    Additional paid-in capital


    667,677



    695,066


    Accumulated other comprehensive income (loss)


    11



    240


    Accumulated deficit


    (609,781)



    (603,678)


    Total stockholders' equity


    58,042



    91,765


    Total liabilities and stockholders' equity


    $

    492,353



    $

    565,874


     

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  35. SAN DIEGO, May 7, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO), will participate in the Bank of America Securities 2020 Healthcare Conference. This conference is being hosted virtually. Dr. Helen Torley, president and chief executive officer, will provide an overview of the company on Thursday, May 14 at 5:00 p.m. ET / 2:00 p.m. PT.

    A live webcast of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following each event. To access a live webcast, please visit Halozyme's website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

    About Halozyme

    Halozyme Therapeutics, Inc. is a biopharma…

    SAN DIEGO, May 7, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO), will participate in the Bank of America Securities 2020 Healthcare Conference. This conference is being hosted virtually. Dr. Helen Torley, president and chief executive officer, will provide an overview of the company on Thursday, May 14 at 5:00 p.m. ET / 2:00 p.m. PT.

    A live webcast of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following each event. To access a live webcast, please visit Halozyme's website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

    About Halozyme

    Halozyme Therapeutics, Inc. is a biopharma technology platform company that provides innovative and disruptive solutions with the goal of improving patient experience and outcomes. Our proprietary enzyme rHuPH20 is used to facilitate the delivery of injected drugs and fluids. We license our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug delivery technology with the collaborators' proprietary compounds. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Contact:
    Al Kildani
    Vice President, Investor Relations and Corporate Communications
    858-704-8122

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  36. SAN DIEGO, May 1, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that its collaborator Janssen Biotech, Inc. (Janssen) has received approval from the U.S. Food and Drug Administration (FDA) for DARZALEX FASPRO™ (daratumumab hyaluronidase human- fihj). DARZALEX FASPRO™ is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients.

    "We are delighted that DARZALEX FASPRO™ has been approved in the U.S. making it possible for patients diagnosed with multiple myeloma to receive daratumumab (DARZALEX®) treatment in 3-5 minutes with a subcutaneous injection rather than through a multi-hour intravenous…

    SAN DIEGO, May 1, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that its collaborator Janssen Biotech, Inc. (Janssen) has received approval from the U.S. Food and Drug Administration (FDA) for DARZALEX FASPRO™ (daratumumab hyaluronidase human- fihj). DARZALEX FASPRO™ is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients.

    "We are delighted that DARZALEX FASPRO™ has been approved in the U.S. making it possible for patients diagnosed with multiple myeloma to receive daratumumab (DARZALEX®) treatment in 3-5 minutes with a subcutaneous injection rather than through a multi-hour intravenous infusion. This can reduce the treatment burden for patients, significantly shortening the time required in the physician clinic, hospital in-patient and out-patient treatment centers," said Dr. Helen Torley, president and chief executive officer. "We are also pleased with the breadth of indications granted to DARZALEX FASPRO™, which includes the majority of the indications granted for the IV DARZALEX® formulation."

    DARZALEX FASPRO™ is approved for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

    About ENHANZE® Technology 
    Halozyme's proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

    About Halozyme
    Halozyme Therapeutics, Inc. is a biopharma technology platform company that provides innovative and disruptive solutions with the goal of improving patient experience and outcomes. Our proprietary enzyme rHUPH20 is used to facilitate the delivery of injected drugs and fluids. We license our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug delivery technology with the collaborators' proprietary compounds. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Halozyme Safe Harbor Statement
    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes from being treated with the newly-approved ENHANZE® co-formulated product referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    Contact:
    Al Kildani
    Vice President, Investor Relations and Corporate Communications
    858-704-8122

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  37. SAN DIEGO, April 30, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Janssen-Cilag International NV (Janssen)  received a Committee for Medicinal Products for Human Use (CHMP) Positive Opinion from the European Medicines Agency (EMA) recommending approval of a DARZALEX® (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma in frontline and relapsed/refractory settings.  The CHMP's Positive Opinion for daratumumab SC formulation applies to all current daratumumab indications including newly diagnosed and transplant-ineligible patients, as well as relapsed or refractory patients. 

    The DARZALEX® SC formulation utilizes Halozyme's ENHANZE® drug delivery technology…

    SAN DIEGO, April 30, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Janssen-Cilag International NV (Janssen)  received a Committee for Medicinal Products for Human Use (CHMP) Positive Opinion from the European Medicines Agency (EMA) recommending approval of a DARZALEX® (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma in frontline and relapsed/refractory settings.  The CHMP's Positive Opinion for daratumumab SC formulation applies to all current daratumumab indications including newly diagnosed and transplant-ineligible patients, as well as relapsed or refractory patients. 

    The DARZALEX® SC formulation utilizes Halozyme's ENHANZE® drug delivery technology and reduces the treatment time from several hours to approximately five minutes with comparable efficacy to intravenous DARZALEX® and lower rates of infusion-related reactions.

    "We are excited that a subcutaneous formulation of DARZALEX® is one step closer to transforming the treatment experience for multiple myeloma patients and physicians in the European Union," said Dr. Helen Torley, president and chief executive officer. "Once available, multiple myeloma patients may benefit from a shorter infusion time when compared with a multi-hour intravenous infusion."

    The CHMP opinion is supported by data from Janssen's Phase 3 COLUMBA study, which investigated subcutaneously administered DARZALEX® in comparison to intravenous DARZALEX® in patients with relapsed and refractory multiple myeloma, and the Phase 2 PLEIADES study. In the COLUMBA study, subcutaneous DARZALEX®, using ENHANZE® drug delivery technology, was found to be non-inferior to intravenous DARZALEX® with regard to the co-primary endpoints of overall response rate and maximum Ctrough concentration on day 1 of the third treatment cycle prior to dose.

    About ENHANZE® Technology 

    Halozyme's proprietary ENHANZE® drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

    About Halozyme

    Halozyme Therapeutics, Inc. is a biopharma technology platform company that provides innovative and disruptive solutions with the goal of improving patient experience and outcomes. Our proprietary enzyme rHuPH20 is used to facilitate the delivery of injected drugs and fluids. We license our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug delivery technology with the collaborators' proprietary compounds. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Halozyme Safe Harbor Statement

    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

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    SOURCE Halozyme Therapeutics, Inc.

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  38. SAN DIEGO, April 28, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) will webcast its Quarterly Update Conference Call for the first quarter 2020 on Monday, May 11 at 4:30 p.m. ET / 1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the first quarter ended March 31, 2020 following the close of trading.

    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 the Investors page of www.halozyme.com approximately fifteen minutes prior to the call…

    SAN DIEGO, April 28, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) will webcast its Quarterly Update Conference Call for the first quarter 2020 on Monday, May 11 at 4:30 p.m. ET / 1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call. On the same date, Halozyme will release financial results for the first quarter ended March 31, 2020 following the close of trading.

    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 the Investors page of www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The live call may be accessed by dialing (833) 968-2181 (domestic callers) or (825) 312-2108 (international callers). Callers must enter Conference ID 3199114. A telephone replay will be available after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 3199114.

    About Halozyme

    Halozyme Therapeutics, Inc. is a biopharma technology platform company that provides innovative and disruptive solutions with the goal of improving patient experience and outcomes. Our proprietary enzyme rHuPH20 is used to facilitate the delivery of injected drugs and fluids. We license our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug delivery technology with the collaborators' proprietary compounds. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Contact:
    Al Kildani
    Vice President, Investor Relations and Corporate Communications
    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

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    SOURCE Halozyme Therapeutics, Inc.

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  39. SAN DIEGO, April 26, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced the submission of a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) by Janssen Pharmaceutical K.K. (Janssen) seeking approval of a new subcutaneous (SC) formulation of daratumumab, an intravenous (IV) treatment approved for patients with multiple myeloma.

    "We are pleased to see this New Drug Application submission in Japan, which builds on Janssen's prior regulatory submissions in the U.S. and EU that are currently under review," said Dr. Helen Torley, president and chief executive officer. "We are excited that patients with multiple myeloma in Japan may soon have a new therapeutic option that can be administered…

    SAN DIEGO, April 26, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced the submission of a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) by Janssen Pharmaceutical K.K. (Janssen) seeking approval of a new subcutaneous (SC) formulation of daratumumab, an intravenous (IV) treatment approved for patients with multiple myeloma.

    "We are pleased to see this New Drug Application submission in Japan, which builds on Janssen's prior regulatory submissions in the U.S. and EU that are currently under review," said Dr. Helen Torley, president and chief executive officer. "We are excited that patients with multiple myeloma in Japan may soon have a new therapeutic option that can be administered with a shorter infusion time when compared with a multi-hour intravenous infusion."

    The NDA is supported by pivotal data from the Phase 3 COLUMBA (MMY3012) study – a randomized open label study – that included a non-inferiority comparison of daratumumab SC formulation versus daratumumab IV administration in patients with multiple myeloma who had received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or whose disease was refractory to both PI and IMiD. In addition to non-inferiority, daratumumab SC showed a lower rate of infusion-related reactions. Data from the Phase 2 PLEIADES (MMY2040) study – a non-randomized open label study conducted in newly diagnosed or relapsed or refractory multiple myeloma patients – are also included in the NDA. The subcutaneous formulation of daratumumab is co-formulated with Halozyme's ENHANZE® drug delivery technology, based on recombinant human hyaluronidase PH20 (rHuPH20).

    About ENHANZE® Technology 
    Halozyme's proprietary ENHANZE® drug delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.

    About Halozyme
    Halozyme Therapeutics, Inc. is a biopharma technology platform company that provides innovative and disruptive solutions with the goal of improving patient experience and outcomes. Our proprietary enzyme rHuPH20 is used to facilitate the delivery of injected drugs and fluids. We license our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug delivery technology with the collaborators' proprietary compounds. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Halozyme Safe Harbor Statement
    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery. These forward-looking statements also include statements regarding the product development efforts of Halozyme's ENHANZE® partner. These forward-looking statements involve risks 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 uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    Contact:
    Al Kildani
    Vice President, Investor Relations and Corporate Communications
    858-704-8122

     

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

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    SOURCE Halozyme Therapeutics, Inc.

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  40. SAN DIEGO, April 3, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that due to the emerging public health impact of the coronavirus outbreak (COVID-19), to support the health and well-being of our employees and stockholders, and to comply with the State of California's stay at home order, its Board of Directors has approved a change in the location of its 2020 Annual Meeting of Stockholders to a virtual-only shareholder meeting instead of an in-person meeting.  As previously announced, the Annual Meeting will be held on Thursday, April 30, 2020 at 8:00 a.m. local time. Stockholders will not be able to attend the Annual Meeting physically in person.

    As described in the proxy materials for the Annual Meeting previously…

    SAN DIEGO, April 3, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that due to the emerging public health impact of the coronavirus outbreak (COVID-19), to support the health and well-being of our employees and stockholders, and to comply with the State of California's stay at home order, its Board of Directors has approved a change in the location of its 2020 Annual Meeting of Stockholders to a virtual-only shareholder meeting instead of an in-person meeting.  As previously announced, the Annual Meeting will be held on Thursday, April 30, 2020 at 8:00 a.m. local time. Stockholders will not be able to attend the Annual Meeting physically in person.

    As described in the proxy materials for the Annual Meeting previously distributed, stockholders are entitled to participate in the Annual Meeting if they were a stockholder as of the close of business on March 2, 2020, the record date, or hold a legal proxy for the meeting provided by their bank, broker, or nominee.

    To be admitted to the Annual Meeting at www.virtualshareholdermeeting.com/HALO2020, stockholders must enter the control number found on the proxy card, voting instruction form or notice they previously received. Stockholders may vote during the Annual Meeting by following the instructions available on the meeting website during the meeting. The meeting's virtual attendance format will provide stockholders the ability to participate and ask questions in writing during the meeting.  Whether or not they plan to attend the Annual Meeting, our stockholders are urged to vote and submit their proxy in advance of the meeting by one of the methods described in the proxy materials for the Annual Meeting. The proxy card included with the proxy materials previously distributed will not be updated to reflect the change in location and format and may continue to be used to vote your shares in connection with the Annual Meeting.

    About Halozyme
    Halozyme Therapeutics, Inc. is a biopharma technology platform company that provides innovative and disruptive solutions with the goal of improving patient experience and outcomes. Our proprietary enzyme rHUPH20 is used to facilitate the delivery of injected drugs and fluids. We license our technology to biopharmaceutical companies to collaboratively develop products that combine our ENHANZE® drug delivery technology with the collaborators' proprietary compounds. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Contact:
    Al Kildani
    Vice President, Investor Relations and Corporate Communications
    858-704-8122

    Halozyme Therapeutics, Inc. Logo. (PRNewsFoto/Halozyme Therapeutics, Inc.)

     

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  41. SAN DIEGO, Feb. 26, 2020 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) will be presenting at the Cowen and Company 40th Annual Health Care Conference on Wednesday, March 4 at 11:20 a.m. ET / 8:20 a.m. PT in Boston. Dr. Helen Torley, president and chief executive officer, will provide a corporate overview.

    The presentation will be webcast through the "Investors" section of Halozyme's corporate website at www.halozyme.com, and a recording will be made available for 90 days following the event. To access a live webcast, please visit Halozyme's website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

    About Halozyme

    Halozyme Therapeutics Inc. is a biopharma technology platform company…