HALO Halozyme Therapeutics Inc.

26.28
-0.23  -1%
Previous Close 26.51
Open 26.61
52 Week Low 12.71
52 Week High 29.77
Market Cap $3,601,060,888
Shares 137,026,670
Float 121,990,461
Enterprise Value $3,557,734,553
Volume 1,135,958
Av. Daily Volume 1,000,216
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Drug Pipeline

Drug Stage Notes
Atezolizumab (Tecentriq) using ENHANZE - (IMscin001)
Non-small cell lung cancer (NSCLC)
Phase 1b
Phase 1b
Phase 1b data presented at ESMO 2020 noted treatment was well tolerated.
DARZALEX (Daratumumab) using ENHANZE
Amyloidosis
sNDA Filing
sNDA Filing
sBLA filing announced September 10, 2020.
ARGX-117
Autoimmune diseases
Phase 1
Phase 1
Phase 1 trial to commence 3Q 2020.
Subcutaneous Pertuzumab And Trastuzumab
HER2-positive early breast cancer
Approved
Approved
FDA Approval announced June 29, 2020.
DARZALEX (Daratumumab) using ENHANZE
Multiple myeloma
Approved
Approved
FDA Approval announced May 1, 2020.
PEGPH20 and atezolizumab
Cholangiocarcinoma
Phase 1b
Phase 1b
Phase 1b trial ongoing. 42/70 patients have enrolled as of December 2018.
HALO-301
Pancreatic cancer
Phase 3
Phase 3
Phase 3 data November 4, 2019 did not meet primary endpoint.
Trastuzumab (Herceptin) using ENHANZE
Breast cancer
Approved
Approved
FDA approval announced February 28, 2019.
HYQVIA
Subcutaneous treatment for patients with primary immunodeficiency (PI)
Approved
Approved
Approved September 12, 2014.
PEGPH20 in Combination with docetaxel
Non-small cell lung cancer (NSCLC)
Phase 1b
Phase 1b
Discontinued August 2016
Subcutaneous rituximab
Various blood cancers
Approved
Approved
Approval announced June 22, 2017.

Latest News

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

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

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

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

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

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

    About Halozyme

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

    Safe Harbor Statement

    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, the product development and approval efforts of Halozyme's ENHANZE® partners, including the potential continued evaluation of atezolizumab with ENHANZE® in a Phase 3 clinical study, and statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and lowering the treatment burden for patients. These forward-looking statements also include statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning whether the collaborative product referred to in this press release is ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

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

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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

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    SOURCE Halozyme Therapeutics, Inc.

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

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

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

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

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

    About Halozyme

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

    Safe Harbor Statement

    In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, the product development and approval efforts of Halozyme's ENHANZE® partners and statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery. These forward-looking statements also include statements regarding the FDA Real-Time Oncology Review program and the potential for a more efficient regulatory review process of the sBLA referenced in this press release. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning whether collaborative products are ultimately developed, approved or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review, unexpected regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

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

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

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

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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

     

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    SOURCE Halozyme Therapeutics, Inc.

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

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

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

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

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

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

    About Halozyme

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

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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

     

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

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

    About Halozyme

    Halozyme is a biopharmaceutical…

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

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

    About Halozyme

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

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    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-2020-wells-fargo-virtual-healthcare-conference-301123227.html

    SOURCE Halozyme Therapeutics, Inc.

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

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

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

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

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

    Second Quarter 2020 and Recent Highlights Include:

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

    Second Quarter 2020 Financial Highlights

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

    Financial Outlook for 2020

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

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

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

    Webcast and Conference Call

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

    About Halozyme

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

    Safe Harbor Statement

    In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance (including the Company's financial outlook for 2020) and expectations for future growth, profitability, revenue, margins, expenses and earnings-per-share and the Company's plans to continue its share repurchase program.  Forward-looking statements regarding the Company's ENHANZE® drug delivery technology may include the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs and facilitating more rapid delivery of injectable medications through subcutaneous delivery. Forward-looking statements regarding the Company's ENHANZE®  business may include potential growth driven by our partners' development and commercialization efforts, the size and growth prospects of our partners' drug franchises, potential new ENHANZE® collaborations and collaborative targets and regulatory review and potential approvals of new ENHANZE® products. These forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, inability to sustain profitability, unexpected delays in the execution of the Company's  share repurchase program, unexpected results or delays in the growth of the Company's ENHANZE® business, or in the development, regulatory review or commercialization of ENHANZE® products, including any potential delays caused by the current COVID-19 global pandemic, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-K filed with the Securities and Exchange Commission.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

    Halozyme Therapeutics, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per share amounts)







    Three Months Ended 

     June 30,



    Six Months Ended





    2020



    2019



    2020



    2019

    Revenues:

















    Royalties



    $

    15,846





    $

    18,107





    $

    32,668





    $

    36,060



    Product sales, net



    6,337





    5,760





    14,484





    14,150



    Revenues under collaborative agreements



    33,038





    15,281





    33,423





    45,887



    Total revenues



    55,221





    39,148





    80,575





    96,097



    Operating expenses:

















    Cost of product sales



    5,740





    1,877





    11,527





    6,526



    Research and development



    8,951





    33,910





    19,109





    65,238



    Selling, general and administrative



    10,975





    17,338





    23,607





    35,344



    Total operating expenses



    25,666





    53,125





    54,243





    107,108



    Operating income (loss)



    29,555





    (13,977)





    26,332





    (11,011)



    Other income (expense):

















    Investment and other income, net



    1,324





    1,983





    3,803





    4,040



    Interest expense



    (5,004)





    (2,613)





    (10,352)





    (5,818)



    Net income (loss) before income taxes



    25,875





    (14,607)





    19,783





    (12,789)



    Income tax expense



    58





    17





    69





    39



    Net income (loss)



    $

    25,817





    $

    (14,624)





    $

    19,714





    $

    (12,828)





















    Net income (loss) per share:

















    Basic



    $

    0.19





    $

    (0.10)





    $

    0.14





    $

    (0.09)



    Diluted



    $

    0.19





    $

    (0.10)





    $

    0.14





    $

    (0.09)





















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

















    Basic



    135,935





    145,411





    136,572





    145,051



    Diluted



    138,084





    145,411





    138,837





    145,051



     

    Halozyme Therapeutics, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited)

    (In thousands)







    June 30, 

     2020



    December 31, 

     2019

    ASSETS









    Current assets:









    Cash and cash equivalents



    $

    133,606





    $

    120,179



    Marketable securities, available-for-sale



    251,840





    301,083



    Accounts receivable, net



    37,401





    59,442



    Inventories



    48,271





    29,359



    Prepaid expenses and other assets



    29,240





    33,373



    Total current assets



    500,358





    543,436



    Property and equipment, net



    11,169





    10,855



    Prepaid expenses and other assets



    14,970





    11,083



    Restricted cash



    500





    500



    Total assets



    $

    526,997





    $

    565,874













    LIABILITIES AND STOCKHOLDERS' EQUITY









    Current liabilities:









    Accounts payable



    $

    4,067





    $

    6,434



    Accrued expenses



    21,258





    55,649



    Deferred revenue, current portion



    748





    4,012



    Current portion of long-term debt, net







    19,542



    Total current liabilities



    26,073





    85,637













    Deferred revenue, net of current portion



    641





    1,247



    Long-term debt, net



    390,079





    383,045



    Other long-term liabilities



    4,627





    4,180













    Stockholders' equity:









    Common stock



    137





    137



    Additional paid-in capital



    688,318





    695,066



    Accumulated other comprehensive income (loss)



    1,086





    240



    Accumulated deficit



    (583,964)





    (603,678)



    Total stockholders' equity



    105,577





    91,765



    Total liabilities and stockholders' equity



    $

    526,997





    $

    565,874



     

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