1. SAN DIEGO, Sept. 15, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Elaine Sun, senior vice president and chief financial officer, will present at the 2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 1:20 p.m. Eastern Time / 10:20 a.m. Pacific Time.

    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 6 months 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…

    SAN DIEGO, Sept. 15, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Elaine Sun, senior vice president and chief financial officer, will present at the 2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 1:20 p.m. Eastern Time / 10:20 a.m. Pacific Time.

    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 6 months 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 touched more than 500,000 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 AbbVie, Alexion, argenx, Baxalta, Bristol-Myers Squibb, Horizon, Janssen, Lilly, Pfizer, Roche and ViiV Healthcare. 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 Halozyme.com and connect with us on LinkedIn and Twitter.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    ir@halozyme.com

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

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  2. SAN DIEGO, Aug. 26, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will present at the Wells Fargo 2021 Virtual Healthcare Conference on Friday, September 10, 2021 at 10:40 a.m. Eastern Time / 7:40 a.m. Pacific Time.

    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 6 months 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…

    SAN DIEGO, Aug. 26, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will present at the Wells Fargo 2021 Virtual Healthcare Conference on Friday, September 10, 2021 at 10:40 a.m. Eastern Time / 7:40 a.m. Pacific Time.

    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 6 months 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 touched more than 500,000 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, Horizon Therapeutics and ViiV Healthcare. 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 using ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    ir@halozyme.com

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

     

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  3. SAN DIEGO, Aug. 9, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today reported financial results for the second quarter ended June 30, 2021 and provided an update on its recent corporate activities and outlook.

    "Our excellent start to 2021 continued in the second quarter with strong quarterly growth resulting in record quarterly revenues from royalties and the signing of our eleventh collaboration and license agreement," said Dr. Helen Torley, president and chief executive officer. "Our recently announced collaboration with ViiV Healthcare demonstrates the potential for our ENHANZE® technology to meet evolving patients' needs by creating long-acting drugs that facilitate rapid, large volume subcutaneous injections of small…

    SAN DIEGO, Aug. 9, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today reported financial results for the second quarter ended June 30, 2021 and provided an update on its recent corporate activities and outlook.

    "Our excellent start to 2021 continued in the second quarter with strong quarterly growth resulting in record quarterly revenues from royalties and the signing of our eleventh collaboration and license agreement," said Dr. Helen Torley, president and chief executive officer. "Our recently announced collaboration with ViiV Healthcare demonstrates the potential for our ENHANZE® technology to meet evolving patients' needs by creating long-acting drugs that facilitate rapid, large volume subcutaneous injections of small molecule drugs. This collaboration also highlights the potential for ENHANZE® in new disease areas like infectious disease. As a result of this new collaboration and our strong results to date, we are pleased to share that we are raising our guidance for revenues and earnings for the year."

     Recent Partner Highlights:

    • In July 2021, Janssen received U.S. Food and Drug Administration (FDA) approval for DARZALEX FASPRO® (daratumumab and hyaluronidase - fijh) in combination with pomalidomide and dexamethasone for patients with multiple myeloma after first or subsequent relapse, marking the sixth indication for DARZALEX FASPRO® in the treatment of multiple myeloma.
    • In June 2021, Halozyme announced a global collaboration and license agreement with ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc. This license gives ViiV exclusive access to Halozyme's ENHANZE® technology for four specific small and large molecule targets for the treatment and prevention of HIV. Under the terms of the agreement, Halozyme received an upfront payment of $40 million and ViiV is obligated to make potential future payments of up to $175 million in development and commercial milestones per target, subject to achievement of specified development and commercial milestones, including certain specified sales milestones. Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialized medicines using the ENHANZE® technology.
    • In June 2021, Janssen was granted two marketing authorizations by the European Commission (EC) for DARZALEX® (daratumumab) SC in two new indications in the European Union. The first authorization was for use in combination with cyclophosphamide, bortezomib and dexamethasone (D-VCd) in newly diagnosed adult patients with systemic light chain (AL) amyloidosis marking the first approved therapy for AL amyloidosis in Europe. The second authorization was for use in combination with pomalidomide and dexamethasone (D-Pd) in adult patients with relapsed or refractory multiple myeloma.
    • In June 2021, Bristol Myers Squibb enrolled the first patient in a Phase 3 study of nivolumab using ENHANZE® technology for patients with advanced or metastatic clear cell renal cell carcinoma.

     Recent Corporate Highlights:  

    • During the second quarter, the Company repurchased approximately 1.0 million shares of common stock for $48.8 million at an average price per share of $47.05, achieving its target for share repurchases in 2021 with a total of $125 million at an average price per share of $44.43.

    Second Quarter Financial Highlights

    • Revenue for the second quarter was $136.5 million compared to $55.2 million for the second quarter of 2020. The year-over-year increase was primarily driven by $60.0 million in milestone revenues, including $40 million from ViiV and $20 million from Janssen that was earned upon achievement of a commercial milestone related to subcutaneous DARZALEX®, an increase in royalty revenue primarily attributable to subcutaneous DARZALEX® and an increase in product sales. Revenue for the quarter included $45.8 million in royalties, an increase of 189% compared to $15.8 million in the prior year period.
    • Cost of product sales for the second quarter was $23.0 million, compared to $5.7 million for the second quarter of 2020. The year-over-year increase was primarily driven by higher product sales, principally the sales of bulk rHuPH20 to the Company's partners.
    • Research and development expenses for the second quarter were $8.1 million, compared to $9.0 million for the second quarter of 2020. The decrease in expenses was due to the discontinuation of some development related activities for PEGPH20 and closure of the Company's oncology operations, partially offset by an increase in costs to support additional ENHANZE® targets.
    • Selling, general and administrative expenses for the second quarter were $12.3 million, compared to $11.0 million for the second quarter of 2020. The increase was primarily due to an increase in compensation expense, including stock compensation, for personnel to support additional ENHANZE® targets entering clinical development.
    • Operating Income: On a GAAP basis in the second quarter of 2021, operating income was $93.0 million, compared to an operating income of $29.6 million in the second quarter of 2020.
    • Net Income: On a GAAP basis in the second quarter of 2021, net income was $91.5 million, compared with net income of $25.8 million in the second quarter of 2020. Non-GAAP net income was $97.8 million in the second quarter of 2021, compared with Non-GAAP net income of $33.6 million in the second quarter of 2020.1
    • Earnings per Share: On a GAAP basis in the second quarter of 2021, diluted earnings per share was $0.62, compared with $0.19 in the second quarter of 2020. On a Non-GAAP basis diluted earnings per share was $0.66, compared with diluted earnings per share of $0.24 in the second quarter of 2020.1
    • Cash, cash equivalents and marketable securities were $755.3 million on June 30, 2021, compared to $368.0 million on December 31, 2020.
    • During the second quarter, the Company repurchased 1.0 million shares of common stock for $48.8 million at an average price of $47.05, bringing the total for share repurchases since the announcement of the Company's three-year share repurchase program to $475.0 million at an average price of $23.27.

    Financial Outlook for 2021

    Based on the recent signing of a new collaboration and license agreement and strong year-to-date results as well as the latest information from collaboration partners and planned expenditures for the year, the Company is raising guidance for 2021 and now expects:

    • Revenues of $425 million to $445 million, representing year-over-year growth of 59%-66%, and up from prior guidance of $375 to $395 million;
    • GAAP Operating Income of $260 million to $280 million, representing year-over-year growth of 80%-94%;
    • GAAP Net Income of $235 million to $255 million, representing year-over-year growth of 82%-98% and Non-GAAP Net Income of $280 million to $300 million, representing year-over-year growth of 75%-87%;1
    • GAAP Diluted Earnings per Share of $1.55 to $1.70, representing year-over-year growth of 70%-86%, up from prior guidance of $1.25 to $1.40; and
    • Non-GAAP Diluted Earnings per Share of $1.85 to $2.00, representing year-over-year growth of 65%-78%, up from prior guidance of $1.55 to $1.70.1

    Webcast and Conference Call

    Halozyme will webcast its Quarterly Update Conference Call for the second quarter of 2021 today, Monday, August 9, 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/5694076. 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, please register 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 touched more than 500,000 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, Horizon Therapeutics and Viiv Healthcare. 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 using ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.

    Note Regarding Use of Non-GAAP Financial Measures

    In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), this press release and the accompanying tables contain certain Non-GAAP financial measures. The Company reports Non-GAAP net income and Non-GAAP diluted earnings per share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates Non-GAAP net income and Non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discount, and debt extinguishment expense. Reconciliations between GAAP and Non-GAAP financial measures are included at the end of this press release.  The Company evaluates other items of income and expense on an individual basis and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of Halozyme's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These Non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP; and are not prepared under any comprehensive set of accounting rules or principles.  In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its Non-GAAP financial measures; and the Company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP financial measures. Halozyme considers these Non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The Non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations.

    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 and administration of larger volumes of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's ENHANZE® business may include potential growth and receipt of royalty and milestone payments 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, 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 and Form 10-Q filed with the Securities and Exchange Commission.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    ir@halozyme.com

    Footnotes:

    1. Reconciliations between GAAP reported and non-GAAP financial information and adjusted guidance measures are provided at the end of this press release.

     

    Halozyme Therapeutics, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per share amounts)







    Three Months Ended

     June 30,



    Six Months Ended

    June 30,





    2021



    2020



    2021



    2020

    Revenues:

















    Royalties



    $

    45,778





    $

    15,846





    $

    82,701





    $

    32,668



    Product sales, net



    30,360





    6,337





    52,126





    14,484



    Revenues under collaborative agreements



    60,317





    33,038





    90,650





    33,423



    Total revenues



    136,455





    55,221





    225,477





    80,575



    Operating expenses:

















    Cost of product sales



    23,018





    5,740





    41,237





    11,527



    Research and development



    8,069





    8,951





    17,078





    19,109



    Selling, general and administrative



    12,321





    10,975





    23,380





    23,607



    Total operating expenses



    43,408





    25,666





    81,695





    54,243



    Operating income (loss)



    93,047





    29,555





    143,782





    26,332



    Other income (expense):

















    Investment and other income, net



    221





    1,324





    497





    3,803



    Inducement expense related to convertible note











    (20,960)







    Interest expense



    (1,752)





    (5,004)





    (3,717)





    (10,352)



    Net income (loss) before income taxes



    91,516





    25,875





    119,602





    19,783



    Income tax expense



    58





    58





    249





    69



    Net income (loss)



    $

    91,458





    $

    25,817





    $

    119,353





    $

    19,714





















    Net income (loss) per share:

















    Basic



    $

    0.64





    $

    0.19





    $

    0.85





    $

    0.14



    Diluted



    $

    0.62





    $

    0.19





    $

    0.81





    $

    0.14





















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

















    Basic



    142,487





    135,935





    140,201





    136,572



    Diluted



    147,624





    138,084





    148,096





    138,837



     

    Halozyme Therapeutics, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited)

    (In thousands)







    June 30,

    2021



    December 31,

    2020

    ASSETS









    Current assets:









    Cash and cash equivalents



    $

    446,966





    $

    147,703



    Marketable securities, available-for-sale



    308,343





    220,310



    Accounts receivable, net and other contract assets



    153,196





    97,730



    Inventories



    58,554





    60,747



    Prepaid expenses and other assets



    32,691





    28,274



    Total current assets



    999,750





    554,764



    Property and equipment, net



    10,132





    10,593



    Prepaid expenses and other assets



    15,481





    14,067



    Restricted cash



    500





    500



    Total assets



    $

    1,025,863





    $

    579,924













    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









    Accounts payable



    $

    4,563





    $

    1,928



    Accrued expenses



    19,274





    20,483



    Deferred revenue, current portion



    1,247





    1,746



    Current portion of long-term debt, net



    89,167





    397,228



    Total current liabilities



    114,251





    421,385













    Deferred revenue, net of current portion



    4,026





    4,026



    Long-term debt, net



    785,571







    Other long-term liabilities



    2,267





    3,466













    Stockholders' equity:









    Common stock



    142





    135



    Additional paid-in capital



    461,897





    625,483



    Accumulated other comprehensive income (loss)



    (24)





    22



    Accumulated deficit



    (342,267)





    (474,593)



    Total stockholders' equity



    119,748





    151,047



    Total liabilities and stockholders' equity



    $

    1,025,863





    $

    579,924



     

    Halozyme Therapeutics, Inc.

    GAAP to Non-GAAP Reconciliations

    Net Income and Diluted EPS

    (Unaudited)

    (In thousands, except per share amounts)







    Three Months Ended

     June 30,





    2021



    2020

    GAAP Net Income



    $

    91,458





    $

    25,817



    Adjustments:









    Share-based compensation



    5,372





    4,257



    Amortization of debt discount



    965





    3,510



    Income tax effect of above adjustments (1)



    (4)





    (17)



    Non-GAAP Net Income



    $

    97,791





    $

    33,567













    GAAP Diluted EPS



    $

    0.62





    $

    0.19



    Adjustments:









    Share-based compensation



    0.04





    0.03



    Amortization of debt discount



    0.01





    0.03



    Non-GAAP Diluted EPS



    $

    0.66





    $

    0.24













    GAAP & Non-GAAP Diluted Shares



    147,624





    138,084





    (1) Estimated income tax effect of the Non-GAAP reconciling items are calculated using applicable statutory tax rates, taking into consideration of any valuation allowance.

     

    Halozyme Therapeutics, Inc.

    GAAP to Non-GAAP Reconciliations

    Net Income and Diluted EPS 2021 Guidance

    (Unaudited)

    (In millions, except per share amounts)







    2021



    2020

    GAAP Net Income



    $    235 - 255



    $

    129.1



    Adjustments:









    Inducement expense related to convertible note



    21 - 21





    Share-based compensation



    20 - 21



    17.2



    Amortization of debt discount



    4 - 4



    14.1



    Non-GAAP Net Income



    $    280 - 300



    $

    160.4













    GAAP Diluted EPS



    $  1.55 - 1.70



    $

    0.91



    Adjustments:









    Inducement expense related to convertible note



    0.14 - 0.14





    Share-based compensation



    0.14 - 0.14



    0.12



    Amortization of debt discount



    0.02 - 0.02



    0.10



    Non-GAAP Diluted EPS



    $   1.85 - 2.00



    $

    1.12













    GAAP & Non-GAAP Diluted Shares



    148 - 149



    141.5





    Dollar amounts and percentages, as presented, are rounded. Consequently totals may not add up.

     

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

     

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  4. SAN DIEGO, July 30, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Elaine Sun, senior vice president and chief financial officer, will virtually represent the company in a fireside chat at the Canaccord Genuity 41st Annual Growth Conference Securities 2021 Virtual Health Care Conference on Wednesday, August 11, 2021 at 3:30 p.m. Eastern Time / 12:30 p.m. Pacific Time.

    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 6 months 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…

    SAN DIEGO, July 30, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Elaine Sun, senior vice president and chief financial officer, will virtually represent the company in a fireside chat at the Canaccord Genuity 41st Annual Growth Conference Securities 2021 Virtual Health Care Conference on Wednesday, August 11, 2021 at 3:30 p.m. Eastern Time / 12:30 p.m. Pacific Time.

    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 6 months 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 touched more than 500,000 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 AbbVie, Alexion, argenx, Baxalta, Bristol-Myers Squibb, Horizon, Janssen, Lilly, Pfizer, Roche and ViiV Healthcare. 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 Halozyme.com and connect with us on LinkedIn and Twitter.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    ir@halozyme.com

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

     

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    SOURCE Halozyme Therapeutics, Inc.

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  5. SAN DIEGO, July 27, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) will webcast its Quarterly Update Conference Call for the second quarter 2021 on Monday, August 9 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, 2021 following the close of trading.

    To register for this conference call, please use this link: http://www.directeventreg.com/registration/event/5694076. 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 27, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) will webcast its Quarterly Update Conference Call for the second quarter 2021 on Monday, August 9 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, 2021 following the close of trading.

    To register for this conference call, please use this link: http://www.directeventreg.com/registration/event/5694076. 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 5694076.

    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 touched more than 500,000 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, Horizon Therapeutics and ViiV Healthcare. 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  

    ir@halozyme.com

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

     

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    SOURCE Halozyme Therapeutics, Inc.

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  6. SAN DIEGO, July 12, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. The approval marks Janssen's sixth indication for DARZALEX FASPRO® in the treatment of multiple myeloma. Findings from the Phase 3 APOLLO study were recently published in The Lancet Oncology.

    "We are delighted that Janssen received this FDA approval for DARZALEX FASPRO®, making it…

    SAN DIEGO, July 12, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. The approval marks Janssen's sixth indication for DARZALEX FASPRO® in the treatment of multiple myeloma. Findings from the Phase 3 APOLLO study were recently published in The Lancet Oncology.

    "We are delighted that Janssen received this FDA approval for DARZALEX FASPRO®, making it the first and only FDA-approved subcutaneous anti-CD38 monoclonal antibody therapy available in this combination," said Helen Torley, president and chief executive officer at Halozyme. "This introduces a new delivery option for multiple myeloma patients in the U.S. being treated with this regimen."

    DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.

    This FDA approval for DARZALEX FASPRO® in combination with Pd for patients with multiple myeloma after first or subsequent relapse is supported by data from the Phase 3 APOLLO study, which met its primary endpoint of improved progression-free survival (PFS). For more information related the Phase 3 APOLLO study findings, please view Janssen's press release. 

    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 touched more than 500,000 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, Horizon Therapeutics and ViiV Healthcare. 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, approved or commercialized for the indications referred to in this press release, 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 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.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    ir@halozyme.com

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

     

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    SOURCE Halozyme Therapeutics, Inc.

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  7. SAN DIEGO, June 22, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the European Commission (EC) has granted the Janssen Pharmaceutical Companies of Johnson & Johnson two marketing authorizations for the subcutaneous formulation of daratumumab, known as DARZALEX® SC in the European Union.  The first authorization is for the use of DARZALEX® SC in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adults with newly diagnosed systemic light-chain (AL) amyloidosis. The approval makes the DARZALEX® SC based regimen the first approved therapy for AL amyloidosis in Europe.  The second authorization is for the use of DARZALEX® SC in combination with pomalidomide and dexamethasone…

    SAN DIEGO, June 22, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the European Commission (EC) has granted the Janssen Pharmaceutical Companies of Johnson & Johnson two marketing authorizations for the subcutaneous formulation of daratumumab, known as DARZALEX® SC in the European Union.  The first authorization is for the use of DARZALEX® SC in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) for the treatment of adults with newly diagnosed systemic light-chain (AL) amyloidosis. The approval makes the DARZALEX® SC based regimen the first approved therapy for AL amyloidosis in Europe.  The second authorization is for the use of DARZALEX® SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adults with multiple myeloma (MM) who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or after the last therapy.

    "We are pleased that Janssen received European Commission marketing authorizations for these important new indications," said Helen Torley, president and chief executive officer at Halozyme. "These authorizations will provide new treatment options for certain AL amyloidosis and multiple myeloma patients in Europe."

    DARZALEX® SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.

    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 touched more than 500,000 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, Horizon Therapeutics and ViiV Healthcare. 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, approved or commercialized for the indications referred to in this press release, 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 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.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    ir@halozyme.com

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

     

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    SOURCE Halozyme Therapeutics, Inc.

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  8. Halozyme's drug delivery technology provides the opportunity to administer large volume subcutaneous injections that may enable dosing intervals of every three months and up to six months or longer for ViiV's pipeline of HIV medicines

    ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ("GSK"), with Pfizer Inc. and Shionogi Limited as shareholders, and Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced a global collaboration and license agreement that gives exclusive access to Halozyme's ENHANZE® drug delivery technology, recombinant human hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in the treatment and prevention of HIV.

    This press release features multimedia. View the full release…

    Halozyme's drug delivery technology provides the opportunity to administer large volume subcutaneous injections that may enable dosing intervals of every three months and up to six months or longer for ViiV's pipeline of HIV medicines

    ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ("GSK"), with Pfizer Inc. and Shionogi Limited as shareholders, and Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced a global collaboration and license agreement that gives exclusive access to Halozyme's ENHANZE® drug delivery technology, recombinant human hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in the treatment and prevention of HIV.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210621005867/en/

    Under the terms of the agreement, ViiV Healthcare will make an upfront payment of $40 million to Halozyme for the exclusive license to four HIV small and large molecule targets and is obligated to make potential future payments of up to $175 million in development and commercial milestones per target, subject to achievement of specified development and commercial milestones, including certain specified sales milestones. Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialised medicines using the technology.

    The PH20 enzyme breaks down a substance called hyaluronan (HA) that is found in the body's subcutaneous space (under the skin) that acts as a barrier to the flow of fluid. By breaking down HA locally at the injection site and temporarily removing that barrier, large amounts of fluid can be injected into the subcutaneous space and dispersed. This facilitates the rapid delivery of large volume fluids by subcutaneous injection, potentially reducing the treatment burden of injectable drugs and providing optimised treatment options to patients. The HA is restored under the skin via normal processes within 24-48 hours.

    Halozyme's technology provides ViiV Healthcare with more opportunities to develop ultra-long acting medicines (dosing intervals of three months or longer) with its long-acting portfolio and pipeline products. Plans are underway to initiate the first experiments with the technology by the end of 2021 for investigational, long-acting cabotegravir for prevention of HIV, which is currently administered every two months.

    "Many people living with HIV and those vulnerable to HIV tell us that for a variety of reasons, taking medicine every day is a challenge, and we have listened to them," said Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare. "We believe long-acting medicines are the future of HIV therapies and will help address these unmet needs. Our collaboration with Halozyme will keep us at the forefront of developing additional, innovative new options for HIV treatment and prevention as we work towards reducing the burden of HIV treatment."

    "We are excited to partner with ViiV Healthcare to create new delivery options for innovative medicines for HIV," said Helen Torley, M.B. Ch. B., M.R.C.P., president and chief executive officer, Halozyme. "This collaboration demonstrates the potential value of our technology to facilitate rapid, large volume subcutaneous injections of not only more traditional medicines but also long-acting injectables, including small molecules, which in turn may further extend dosing intervals for people taking medicines for the treatment and prevention of HIV."

    The license gives ViiV exclusive use of Halozyme's proprietary rHuPH20 technology for four, specific HIV medicine targets that will expand opportunities for development of nearly all of ViiV's pipeline assets. These assets are integrase inhibitors, reverse transcriptase inhibitors limited to nucleoside reverse transcriptase inhibitors (NRTI) and nucleoside reverse transcriptase translocation inhibitors (NRTTIs), capsid inhibitors and broadly neutralising monoclonal antibodies (bNAbs), that bind to the gp120 CD4 binding site.

    Halozyme has licensed its technology to 11 pharmaceutical and biotechnology companies, for potential use in oncology, autoimmune disease, rare disease and infectious disease with products currently approved in oncology and immune deficiency indications. In addition, Halozyme currently has a Cooperative Research and Development Agreement with the National Institute of Allergy and Infectious Diseases' Vaccine Research Center in the US, which includes a bNAb, N6LS, that ViiV Healthcare licensed from the National Institutes of Health in 2019.

    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 touched more than 500,000 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, Horizon Therapeutics and ViiV Healthcare. 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.

    About ViiV Healthcare

    ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE:PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aims are to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

    For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

    About GSK

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/en-gb/about-us/.

    Cautionary statement regarding forward-looking statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

    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 and administration of larger volumes of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including potential extension of dosing intervals for people taking medicines for the treatment and prevention of HIV. 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.

    View Full Article Hide Full Article
  9. LONDON and SAN DIEGO, June 22, 2021 /PRNewswire/ -- ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ("GSK"), with Pfizer Inc. and Shionogi Limited as shareholders, and Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced a global collaboration and license agreement that gives exclusive access to Halozyme's ENHANZE® drug delivery technology, recombinant human hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in the treatment and prevention of HIV. 

    Under the terms of the agreement, ViiV Healthcare will make an upfront payment of $40 million to Halozyme for the exclusive license to four HIV small and large molecule targets and is obligated to make potential future payments of up to $175

    LONDON and SAN DIEGO, June 22, 2021 /PRNewswire/ -- ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ("GSK"), with Pfizer Inc. and Shionogi Limited as shareholders, and Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced a global collaboration and license agreement that gives exclusive access to Halozyme's ENHANZE® drug delivery technology, recombinant human hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in the treatment and prevention of HIV. 

    Under the terms of the agreement, ViiV Healthcare will make an upfront payment of $40 million to Halozyme for the exclusive license to four HIV small and large molecule targets and is obligated to make potential future payments of up to $175 million in development and commercial milestones per target, subject to achievement of specified development and commercial milestones, including certain specified sales milestones. Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialised medicines using the technology.

    The PH20 enzyme breaks down a substance called hyaluronan (HA) that is found in the body's subcutaneous space (under the skin) that acts as a barrier to the flow of fluid. By breaking down HA locally at the injection site and temporarily removing that barrier, large amounts of fluid can be injected into the subcutaneous space and dispersed. This facilitates the rapid delivery of large volume fluids by subcutaneous injection, potentially reducing the treatment burden of injectable drugs and providing optimised treatment options to patients. The HA is restored under the skin via normal processes within 24-48 hours.

    Halozyme's technology provides ViiV Healthcare with more opportunities to develop ultra-long acting medicines (dosing intervals of three months or longer) with its long-acting portfolio and pipeline products. Plans are underway to initiate the first experiments with the technology by the end of 2021 for investigational, long-acting cabotegravir for prevention of HIV, which is currently administered every two months. 

    "Many people living with HIV and those vulnerable to HIV tell us that for a variety of reasons, taking medicine every day is a challenge, and we have listened to them," said Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare.  "We believe long-acting medicines are the future of HIV therapies and will help address these unmet needs. Our collaboration with Halozyme will keep us at the forefront of developing additional, innovative new options for HIV treatment and prevention as we work towards reducing the burden of HIV treatment."

    "We are excited to partner with ViiV Healthcare to create new delivery options for innovative medicines for HIV," said Helen Torley, M.B. Ch. B., M.R.C.P., president and chief executive officer, Halozyme. "This collaboration demonstrates the potential value of our technology to facilitate rapid, large volume subcutaneous injections of not only more traditional medicines but also long-acting injectables, including small molecules, which in turn may further extend dosing intervals for people taking medicines for the treatment and prevention of HIV."

    The license gives ViiV exclusive use of Halozyme's proprietary rHuPH20 technology for four, specific HIV medicine targets that will expand opportunities for development of nearly all of ViiV's pipeline assets. These assets are integrase inhibitors, reverse transcriptase inhibitors limited to nucleoside reverse transcriptase inhibitors (NRTI) and nucleoside reverse transcriptase translocation inhibitors (NRTTIs), capsid inhibitors and broadly neutralising monoclonal antibodies (bNAbs), that bind to the gp120 CD4 binding site.

    Halozyme has licensed its technology to 11 pharmaceutical and biotechnology companies, for potential use in oncology, autoimmune disease, rare disease and infectious disease with products currently approved in oncology and immune deficiency indications. In addition, Halozyme currently has a Cooperative Research and Development Agreement with the National Institute of Allergy and Infectious Diseases' Vaccine Research Center in the US, which includes a bNAb, N6LS, that ViiV Healthcare licensed from the National Institutes of Health in 2019.

    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 touched more than 500,000 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, Horizon Therapeutics and ViiV Healthcare.  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

    About ViiV Healthcare

    ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE:PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aims are to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

    For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.   

    About GSK

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/en-gb/about-us/.

    ViiV Healthcare







    Media enquiries:

    Melinda Stubbee

    +1 919 491 0831

    (North Carolina)



    Audrey Abernathy

    +1 919 605 4521

    (North Carolina)

    GSK enquiries: 







    Media enquiries: 

    Simon Steel 

    +44 (0) 20 8047 5502

    (London) 



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    +44 (0) 20 8047 5502

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    +1 804 217 8147

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    +1 202 603 5003

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    Analyst/Investor enquiries:

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    +44 (0) 7392 784784

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    Halozyme enquiries:

    Al Kildani  

    +1 858 704 8122

    (San Diego)

    Cautionary statement regarding forward-looking statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

    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 and administration of larger volumes of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including potential extension of dosing intervals for people taking medicines for the treatment and prevention of HIV.  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.

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

     

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  10. SAN DIEGO, June 1, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced abstracts and presentations by its collaborators for the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held June 4-8, 2021.

    Janssen Research & Development, LLC (Janssen)-sponsored study with therapeutics utilizing ENHANZE® technology:

    Subcutaneous daratumumab in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) in patients with newly diagnosed light chain (AL) amyloidosis  

    • Oral abstract session: Updated results from the Phase 3 ANDROMEDA study of DARZALEX FASPRO® in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of newly diagnosed AL amyloidosis…

    SAN DIEGO, June 1, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced abstracts and presentations by its collaborators for the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held June 4-8, 2021.

    Janssen Research & Development, LLC (Janssen)-sponsored study with therapeutics utilizing ENHANZE® technology:

    Subcutaneous daratumumab in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd) in patients with newly diagnosed light chain (AL) amyloidosis  

    • Oral abstract session: Updated results from the Phase 3 ANDROMEDA study of DARZALEX FASPRO® in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of newly diagnosed AL amyloidosis (Abstract #8003).

    Bristol Myers Squibb-sponsored study with therapeutics utilizing ENHANZE® technology:

    CheckMate 8KX: Phase 1/2 multi-tumor preliminary analyses of a subcutaneous formulation of nivolumab (± rHuPH20)

    • Poster session: The first data on the pharmacokinetics (PK), safety, tolerability, and pharmacodynamics (PD) of subcutaneous nivolumab + rHuPH20 (Abstract #2575).

    Roche-sponsored study with therapeutics utilizing ENHANZE® technology:

    Potential non-drug cost differences associated with the use of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) in the treatment of HER2-positive early breast cancer patients in Western Europe and the United States

    • Poster session: The aim of this study is to estimate the incremental difference in non-drug costs between PH FDC SC and PT IV for a typical patient receiving treatment for HER2-positive early breast cancer in Western Europe and the United States (Abstract #544).

    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 500,000 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, 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 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.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    ir@halozyme.com

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

     

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  11. SAN DIEGO, May 28, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that it will participate at the following investor conferences:

    • The Goldman Sachs 42nd Annual Global Healthcare Conference on Tuesday, June 8, 2021 at 11:20 a.m. ET / 8:20 a.m. ET. Dr. Helen Torley, president and chief executive officer, will represent the company in a fireside chat.
    • The JMP Securities Life Sciences Conference on Thursday, June 17, 2021 at 3:00 p.m. ET / 12:00 p.m. PT. Elaine Sun, senior vice president and chief financial officer, will represent the company in a fireside chat.

    These conferences will be held virtually. Live webcasts of the applicable presentations will be accessible on the company's website www.halozyme.com under…

    SAN DIEGO, May 28, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that it will participate at the following investor conferences:

    • The Goldman Sachs 42nd Annual Global Healthcare Conference on Tuesday, June 8, 2021 at 11:20 a.m. ET / 8:20 a.m. ET. Dr. Helen Torley, president and chief executive officer, will represent the company in a fireside chat.
    • The JMP Securities Life Sciences Conference on Thursday, June 17, 2021 at 3:00 p.m. ET / 12:00 p.m. PT. Elaine Sun, senior vice president and chief financial officer, will represent the company in a fireside chat.

    These conferences will be held virtually. Live webcasts of the applicable presentations will be accessible on the company's website www.halozyme.com under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    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 500,000 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 

    ir@halozyme.com

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

     

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  12. SAN DIEGO, May 21, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Janssen Pharmaceutica N.V.  (Janssen) received two positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending to broaden the existing marketing authorization for the DARZALEX® (daratumumab) subcutaneous (SC) formulation, which uses ENHANZE® technology, in two new indications.  One recommendation is for the use in combination with cyclophosphamide, bortezomib and dexamethasone (D-VCd), for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. The second recommendation is for the use of daratumumab SC in combination with pomalidomide…

    SAN DIEGO, May 21, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Janssen Pharmaceutica N.V.  (Janssen) received two positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending to broaden the existing marketing authorization for the DARZALEX® (daratumumab) subcutaneous (SC) formulation, which uses ENHANZE® technology, in two new indications.  One recommendation is for the use in combination with cyclophosphamide, bortezomib and dexamethasone (D-VCd), for the treatment of adult patients with newly diagnosed systemic light chain (AL) amyloidosis. The second recommendation is for the use of daratumumab SC in combination with pomalidomide and dexamethasone (D-Pd) for the treatment of adult patients with multiple myeloma who have received one prior therapy containing a proteasome inhibitor and lenalidomide and were lenalidomide-refractory, or who have received at least two prior therapies that included lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or after the last therapy. These two positive opinions will next be reviewed by the European Commission (EC), which has the authority to grant final approval of the indications.

    "Janssen's obtaining positive CHMP opinions is an important step forward in the EU and we are delighted subcutaneous DARZALEX® may soon be available in these important new indications," said Helen Torley, president and chief executive officer at Halozyme. "This would be the first approval in Europe for the treatment of AL amyloidosis and also introduces a new treatment option for certain patients with multiple myeloma."

    The Positive CHMP Opinion for the AL amyloidosis indication is supported by data from Janssen's Phase 3 ANDROMEDA study.1 Janssen reported that the study met the primary endpoint of percentage of patients with hematologic complete response. 

    The Positive CHMP Opinion for daratumumab SC in combination with Pd in the treatment of relapsed or refractory multiple myeloma is supported by data from the Phase 3 APOLLO study conducted in collaboration with the European Myeloma Network. 2  Janssen reported that the study met its primary endpoint of improved progression-free survival (PFS). 

    For more information related Phase 3 ANDROMEDA and APOLLO study findings, please view Janssen's press release.

    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 500,000 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, approved or commercialized for the indications referred to in this press release, 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 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.

    References

    1 Comenzo RL et al., Reduction in Absolute Involved Free Light Chain and Difference Between Involved and Uninvolved Free Light Chain Is Associated with Prolonged Major Organ Deterioration Progression-Free Survival in Patients with Newly Diagnosed AL Amyloidosis Receiving Bortezomib, Cyclophosphamide, and Dexamethasone With or Without Daratumumab: Results From ANDROMEDA. Abstract #552. Presented at 2020 American Society of Hematology Annual Meeting.

    2 Dimopoulos, MA et al. APOLLO: Phase 3 Randomized Study of Subcutaneous Daratumumab Plus Pomalidomide and Dexamethasone (D-Pd) Versus Pomalidomide and Dexamethasone (Pd) Alone in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM). Abstract #412. Oral presentation, presented at 2020 American Society of Hematology Annual Meeting.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    ir@halozyme.com

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

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  13. SAN DIEGO, May 10, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today reported financial results for the first quarter ended March 31, 2021 and provided an update on its recent corporate activities and outlook.

    "The first quarter marked a strong start to 2021 highlighted by record quarterly royalty revenue driven by the continued successful launch of subcutaneous DARZALEX® worldwide," said Dr. Helen Torley, president and chief executive officer. "Our pipeline of partnered product candidates using ENHANZE® technology continues to build momentum with four new clinical study starts in the first quarter.  Additionally, we were able to strengthen our balance sheet on highly attractive terms reflective of the strong anticipated…

    SAN DIEGO, May 10, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today reported financial results for the first quarter ended March 31, 2021 and provided an update on its recent corporate activities and outlook.

    "The first quarter marked a strong start to 2021 highlighted by record quarterly royalty revenue driven by the continued successful launch of subcutaneous DARZALEX® worldwide," said Dr. Helen Torley, president and chief executive officer. "Our pipeline of partnered product candidates using ENHANZE® technology continues to build momentum with four new clinical study starts in the first quarter.  Additionally, we were able to strengthen our balance sheet on highly attractive terms reflective of the strong anticipated cash flow generation and growth prospects for Halozyme."

     Recent Partner Highlights:

    • Janssen achieved several important successes related to the subcutaneous formulation of DARZALEX® (daratumumab) using ENHANZE® technology during the first quarter and since including:
      • Janssen Pharmaceutical K.K. announced approval from Japan's Ministry of Health, Labour and Welfare (MHLW) in March for the subcutaneous formulation of DARZALEX® (known as DALACURO® in Japan) for the treatment of multiple myeloma. Accordingly, Halozyme recognized $5 million in milestone revenues.
      • The Janssen Pharmaceutical Companies of Johnson & Johnson announced Health Canada approved DARZALEX® SC (daratumumab injection), a subcutaneous (SC) formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd, also known as DCyBorD) in April for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis. There were previously no approved therapies for the disease.
      • Janssen Biotech, Inc. received U.S. Food and Drug Administration accelerated approval in January for 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. There were previously no approved therapies for the disease.
    • In March, Horizon completed dosing for its first trial exploring a subcutaneous (SC) formulation of TEPEZZA® (teprotumumab-trbw) using ENHANZE® technology. The trial is a small, single-dose Phase 1 pharmacokinetic trial which includes evaluating the use of ENHANZE® drug-delivery technology for a SC formulation, which could potentially shorten drug administration time, reducing healthcare practitioner time and offering additional flexibility and convenience for patients.
    • Bristol Myers Squibb (BMS) has advanced plans to initiate a Phase 3 study of nivolumab with ENHANZE® technology for patients with advanced or metastatic clear cell renal cell carcinoma during the second quarter of 2021. Accordingly, Halozyme recognized $25 million in milestone revenues.
    • During the first quarter, argenx reached two important achievements related to its development of efgartigimod using ENHANZE® including:
      • In February 2021, argenx announced a "go" decision for its late-stage ADHERE trial evaluating subcutaneous (SC) efgartigimod using 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, argenx initiated a Phase 3 study of ARGX-113 using ENHANZE® technology in pemphigus vulgaris and pemphigus foliaceus, rare autoimmune diseases that cause painful blisters on the skin and mucous membranes.

    Recent Corporate Highlights:

    • In March 2021, the Company completed the sale of $805.0 million aggregate principal amount of the 2027 Convertible Senior Notes. A portion of the net proceeds were used to repurchase 80% of the 2024 Convertible Senior Notes. In connection with the note repurchase, the Company paid the holders $370.2 million in cash and issued 9.08 million shares.
    • During the first quarter, the Company repurchased approximately 1.8 million shares of common stock for $76.2 million at an average price per share of $42.89, partially offsetting shares issued to 2024 Convertible Senior Notes holders.

    First Quarter and Full Year 2021 Financial Highlights

    • Revenue for the first quarter was $89.0 million compared to $25.4 million for the first quarter of 2020. The year-over-year increase was primarily driven by $30.0 million in milestone revenues from BMS and Janssen, an increase in royalty revenue attributable to subcutaneous DARZALEX® and an increase in product sales. Revenue for the quarter included $36.9 million in royalties, an increase of 119% compared to $16.8 million in the prior year period.
    • Cost of product sales for the first quarter was $18.2 million, compared to $5.8 million for the first quarter of 2020. The year-over-year increase was primarily driven by higher product sales, principally the sales of bulk rHuPH20 to the Company's partners.
    • Research and development expenses for the first quarter were $9.0 million, compared to $10.2 million for the first quarter of 2020. The decrease in expenses was due to the discontinuation of some development related activities for PEGPH20 and closure of the Company's oncology operations, partially offset by an increase in costs to support additional ENHANZE® targets.
    • Selling, general and administrative expenses for the first quarter were $11.1 million, compared to $12.6 million for the first quarter of 2020. The decrease was primarily due to one-time costs in the prior year related to the discontinuation of the Company's development activities for PEGPH20 and closure of its oncology operations.
    • Operating Income: On a GAAP basis in the first quarter of 2021, operating income was $50.7 million, compared to an operating loss of $3.2 million in the first quarter of 2020.
    • Net Income: On a GAAP basis in the first quarter of 2021, net income was $27.9 million, compared with a net loss of $6.1 million in the first quarter of 2020. Non-GAAP net income was $54.3 million in the first quarter of 2021, compared with Non-GAAP net income of $1.9 million in the first quarter of 2020.1
    • Earnings per Share: On a GAAP basis in the first quarter of 2021, diluted earnings per share was $0.19, compared with a loss per share of $0.04 in the first quarter of 2020. On a non-GAAP basis diluted earnings per share was $0.37, compared with diluted earnings per share of $0.02 in the first quarter of 2020.1
    • Cash, cash equivalents and marketable securities were $764.3 million at March 31, 2021, compared to $368.0 million at December 31, 2020.
    • During the first quarter, the Company repurchased 1.8 million shares of common stock for $76.2 million at an average price of $42.89, bringing the total for share repurchases since the announcement of the Company's three-year share repurchase program to $426.2 million at an average price of $21.99.

    Financial Outlook for 2021

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

    • Revenues of $375 million to $395 million, representing year-over-year growth of 40%-48%;
    • GAAP Operating Income of $215 million to $235 million, representing year-over-year growth of 49% - 63%;
    • GAAP Net Income of $190 million to $210 million, representing year-over-year growth of 47%-63% and Non-GAAP Net Income of $235 million to $255 million, representing year-over-year growth of 47% - 59%;1
    • GAAP Diluted Earnings per Share of $1.25 to $1.40, representing year-over-year growth of 37%-54%; and Non-GAAP Diluted Earnings per Share of $1.55 to $1.70, representing year-over-year growth of 38%-52%.1

    The Company plans to repurchase up to an additional $49 million in common stock this year for a total of 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 first quarter of 2021 today, Monday, May 10, 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/1584694. 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 500,000 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 using ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

    Note Regarding Use of Non-GAAP Financial Measures

    In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), this press release and the accompanying tables contain certain non-GAAP financial measures. The Company reports non-GAAP net income and non-GAAP diluted earnings per share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company calculates non-GAAP net income and non-GAAP diluted earnings per share excluding share-based compensation expense, amortization of debt discount, and debt extinguishment expense. Reconciliations between GAAP and non-GAAP financial measures are included at the end of this press release.  The Company evaluates other items of income and expense on an individual basis and considers both the quantitative and qualitative aspects of the item, including (i) its size and nature, (ii) whether or not it relates to the Company's ongoing business operations and (iii) whether or not the Company expects it to occur as part of Halozyme's normal business on a regular basis. Non-GAAP financial measures do not have any standardized meaning and are therefore unlikely to be comparable to similarly titled measures presented by other companies. These non-GAAP financial measures are not meant to be considered in isolation and should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP; and are not prepared under any comprehensive set of accounting rules or principles.  In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures; and the Company may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. Halozyme considers these non-GAAP financial measures to be important because they provide useful measures of the operating performance of the Company, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events.  The non-GAAP measures also allow investors and analysts to make additional comparisons of the operating activities of the Company's core business over time and with respect to other companies, as well as assessing trends and future expectations.

    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, 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 and Form 10-Q filed with the Securities and Exchange Commission.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    ir@halozyme.com

    Footnotes:

    1. Reconciliations between GAAP reported and non-GAAP financial information and adjusted guidance measures are provided at the end of this press release.

     

    Halozyme Therapeutics, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per share amounts)







    Three Months Ended

    March 31,





    2021



    2020

    Revenues:









    Royalties



    $

    36,923





    $

    16,822



    Product sales, net



    21,766





    8,147



    Revenues under collaborative agreements



    30,333





    385



    Total revenues



    89,022





    25,354



    Operating expenses:









    Cost of product sales



    18,219





    5,787



    Research and development



    9,009





    10,158



    Selling, general and administrative



    11,059





    12,632



    Total operating expenses



    38,287





    28,577



    Operating income (loss)



    50,735





    (3,223)



    Other income (expense):









    Investment and other income, net



    276





    2,479



    Inducement expense related to convertible note



    (20,960)







    Interest expense



    (1,965)





    (5,348)



    Net income (loss) before income taxes



    28,086





    (6,092)



    Income tax expense



    191





    11



    Net income (loss)



    $

    27,895





    $

    (6,103)













    Net income (loss) per share:









    Basic



    $

    0.20





    $

    (0.04)



    Diluted



    $

    0.19





    $

    (0.04)













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









    Basic



    137,952





    137,186



    Diluted



    148,540





    137,186



     

    Halozyme Therapeutics, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited)

    (In thousands)







    March 31,

    2021



    December 31,

    2020

    ASSETS









    Current assets:









    Cash and cash equivalents



    $

    499,450





    $

    147,703



    Marketable securities, available-for-sale



    264,856





    220,310



    Accounts receivable, net and other contract assets



    88,391





    97,730



    Inventories



    58,343





    60,747



    Prepaid expenses and other assets



    30,679





    28,274



    Total current assets



    941,719





    554,764



    Property and equipment, net



    10,366





    10,593



    Prepaid expenses and other assets



    13,997





    14,067



    Restricted cash



    500





    500



    Total assets



    $

    966,582





    $

    579,924













    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









    Accounts payable



    $

    535





    $

    1,928



    Accrued expenses



    16,098





    20,483



    Deferred revenue, current portion



    1,746





    1,746



    Current portion of long-term debt, net



    89,042





    397,228



    Total current liabilities



    107,421





    421,385













    Deferred revenue, net of current portion



    4,026





    4,026



    Long-term debt, net



    784,731







    Other long-term liabilities



    2,809





    3,466













    Stockholders' equity:









    Common stock



    143





    135



    Additional paid-in capital



    501,186





    625,483



    Accumulated other comprehensive income (loss)



    (9)





    22



    Accumulated deficit



    (433,725)





    (474,593)



    Total stockholders' equity



    67,595





    151,047



    Total liabilities and stockholders' equity



    $

    966,582





    $

    579,924



     

    Halozyme Therapeutics, Inc.

    GAAP to Non-GAAP Reconciliations

    Net Income and Diluted EPS

    (Unaudited)

    (In thousands, except per share amounts)







    Three Months Ended

     March 31,





    2021



    2020

    GAAP Net Income (Loss)



    $

    27,895





    $

    (6,103)



    Adjustments:









    Inducement expense related to convertible note



    20,960







    Share-based compensation



    4,923





    4,531



    Amortization of debt discount



    741





    3,478



    Income tax effect of above adjustments



    (181)





    15



    Non-GAAP Net Income (Loss)



    $

    54,338





    $

    1,921













    GAAP Diluted EPS



    $

    0.19





    $

    (0.04)



    Adjustments:









    Inducement expense related to convertible note



    0.14







    Share-based compensation



    0.03





    0.03



    Amortization of debt discount



    0.01





    0.03



    Income tax effect of above adjustments









    Non-GAAP Diluted EPS



    $

    0.37





    $

    0.02













    GAAP & Non-GAAP Diluted Shares



    148,540





    137,186



     

    Halozyme Therapeutics, Inc.

    GAAP to Non-GAAP Reconciliations

    Net Income and Diluted EPS 2021 Guidance

    (Unaudited)

    (In millions, except per share amounts)







    2021



    2020

    GAAP Net Income (Loss)



    $        190 - 210



    $

    129.1



    Adjustments:









    Inducement expense related to convertible note



    21 - 21





    Share-based compensation



    21 - 22



    17.2



    Amortization of debt discount



    4 - 4



    14.1



    Non-GAAP Net Income (Loss)



    $         235 -255



    $

    160.4













    GAAP Diluted EPS



    $      1.25 - 1.40



    $

    0.91



    Adjustments:









    Inducement expense related to convertible note



    0.14 - 0.14





    Share-based compensation



    0.14 - 0.15



    0.12



    Amortization of debt discount



    0.02 - 0.02



    0.10



    Non-GAAP Diluted EPS



    $      1.55 - 1.70



    $

    1.12













    GAAP & Non-GAAP Diluted Shares



    149 - 150



    141.5





    Dollar amounts and percentages, as presented, are rounded. Consequently totals may not add up.

     

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  14. SAN DIEGO, April 29, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will present virtually at the BofA Securities 2021 Virtual Health Care Conference on Tuesday, May 11, 2021 at 12:30 p.m. Eastern Time / 9:30 a.m. Pacific Time

    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 6 months 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…

    SAN DIEGO, April 29, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that Dr. Helen Torley, president and chief executive officer, will present virtually at the BofA Securities 2021 Virtual Health Care Conference on Tuesday, May 11, 2021 at 12:30 p.m. Eastern Time / 9:30 a.m. Pacific Time

    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 6 months 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

    ir@halozyme.com

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  15. SAN DIEGO, April 20, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) will webcast its Quarterly Update Conference Call for the first quarter 2021 on Monday, May 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 first quarter ended March 31, 2021 following the close of trading.

    To register for this conference call, please use this link: http://www.directeventreg.com/registration/event/1584694. 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, April 20, 2021 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ:HALO) will webcast its Quarterly Update Conference Call for the first quarter 2021 on Monday, May 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 first quarter ended March 31, 2021 following the close of trading.

    To register for this conference call, please use this link: http://www.directeventreg.com/registration/event/1584694. 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 1584694.

    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

    ir@halozyme.com

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  16. 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

    ir@halozyme.com

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  17. 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

    ir@halozyme.com

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

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  18. 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

    ir@halozyme.com



    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



     

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

     

     

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  19. 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

    ir@halozyme.com

     

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  20. 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

    ir@halozyme.com

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  21. 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

    ir@halozyme.com

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

     

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  22. 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

    ir@halozyme.com

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  23. 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

    ir@halozyme.com

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  24. 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

    ir@halozyme.com

    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.

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  25. 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

    Investor-relations@horizontherapeutics.com

    Ruth Venning

    Executive Director, Investor Relations

    Investor-relations@horizontherapeutics.com

    U.S. Media Contacts:

    Geoff Curtis

    Executive Vice President, Corporate Affairs & Chief Communications Officer

    media@horizontherapeutics.com

    Ireland Media Contact:

    Gordon MRM

    Ray Gordon

    ray@gordonmrm.ie

    Halozyme contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    ir@halozyme.com

    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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  26. - 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.

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  27. 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

    ir@halozyme.com

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

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/halozyme-to-participate-in-fireside-chat-for-the-piper-sandler-32nd-annual-virtual-healthcare-conference-301176413.html

    SOURCE Halozyme Therapeutics, Inc.

    View Full Article Hide Full Article
  28. 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

    ir@halozyme.com

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

     

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    SOURCE Halozyme Therapeutics, Inc.

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  29. 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

    ir@halozyme.com

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

     

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  30. 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

    index_services@spglobal.com

    Media Inquiries

    spdji.comms@spglobal.com

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    SOURCE S&P Dow Jones Indices

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  31. 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

    ir@halozyme.com

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

     

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    SOURCE Halozyme Therapeutics, Inc.

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  32. 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

    ir@halozyme.com

     

    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 sale