HALO Halozyme Therapeutics Inc.

47.5
-0.17  -0%
Previous Close 47.67
Open 48.37
52 Week Low 12.71
52 Week High 49.02
Market Cap $6,421,194,400
Shares 135,183,040
Float 120,146,831
Enterprise Value $6,491,100,516
Volume 1,096,792
Av. Daily Volume 1,986,949
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Drug Pipeline

Drug Stage Notes
DARZALEX (Daratumumab) using ENHANZE
Amyloidosis
Approved
Approved
FDA approval announced January 15, 2021.
Daratumumab in combination with pomalidomide and dexamethasone
Multiple myeloma
sNDA Filing
sNDA Filing
sBLA filing announced November 12, 2020.
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.
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.
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, 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

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

     

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    SOURCE Halozyme Therapeutics, Inc.

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  2. 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

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

     

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  3. 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

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

     

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  4. 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

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

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

    The Company now expects:

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

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

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

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

    The Company now expects:

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



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

    About Halozyme

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

    Safe Harbor Statement

    In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's expected future financial performance (including the Company's financial outlook for 2020) and expectations for future growth, profitability, revenue, expenses and earnings-per-share. Forward-looking statements regarding the Company's ENHANZE®  business may include potential growth driven by our partners' development and commercialization efforts. These forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected levels of revenues, expenditures and costs, unexpected results or delays in the growth of the Company's ENHANZE® business, or in the development, regulatory review or commercialization of ENHANZE® products, including any potential delays caused by the current COVID-19 global pandemic, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recently filed Annual Report on Form 10-Q filed with the Securities and Exchange Commission.

    Contact:

    Al Kildani

    Vice President, Investor Relations and Corporate Communications

    858-704-8122

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

     

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