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Halozyme to Report Fourth Quarter and Full Year 2025 Financial and Operating Results
Prnewswire· 2026-02-10 21:05
Core Insights - Halozyme Therapeutics, Inc. will release its fourth quarter and full year 2025 financial and operating results on February 17, 2026, after market close [1] - A conference call will be held on the same day at 1:30 PM PT/4:30 PM ET to discuss these results [1] Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through innovative drug delivery solutions [1] - The company is known for its ENHANZE® drug delivery technology, which utilizes the proprietary enzyme rHuPH20 to facilitate subcutaneous delivery of drugs, impacting over one million patients globally [1] - Halozyme has partnered with major pharmaceutical companies such as Roche, Takeda, Pfizer, and others to commercialize its technology across more than 100 markets [1] Technology and Product Development - The company has expanded its drug delivery technology portfolio with Hyperconâ™ and Surf Bio's hyperconcentration technology, which aims to reduce injection volume while maintaining dosage [1] - Hyperconâ™ technology has been licensed to leading biopharmaceutical partners, enhancing the delivery of biologics subcutaneously [1] - Halozyme also develops drug-device combination products using advanced auto-injector technologies to improve patient comfort and adherence [1] Corporate Structure - Halozyme is headquartered in San Diego, California, with additional offices in Ewing, New Jersey; Minnetonka, Minnesota; and Boston, Massachusetts [1]
Halozyme Raises 2025 Revenue Estimates, Raises 2026 and Multi-Year Financial Guidance
Prnewswire· 2026-01-28 11:30
Core Insights - Halozyme Therapeutics has raised its revenue estimates for 2025 and provided updated financial guidance for 2026, reflecting strong growth in its core ENHANZE business and recent acquisitions [1] Financial Estimates for 2025 - Total revenue is estimated to be between $1,385 million and $1,400 million, representing a year-over-year growth of 36% to 38% [1] - Royalty revenue is projected to be between $865 million and $870 million, with a year-over-year growth of 51% to 52% [1] Financial Guidance for 2026 - Total revenue guidance has been increased to a range of $1,710 million to $1,810 million, indicating a year-over-year growth of 23% to 30% [1] - Royalty revenue guidance has been raised to between $1,130 million and $1,170 million, reflecting a growth of 30% to 35% compared to 2025 [1] - Adjusted EBITDA is expected to be between $1,125 million and $1,205 million [1] - Non-GAAP diluted EPS is projected to be between $7.75 and $8.25 [1] Strategic Acquisitions - The company acquired Surf Bio for an upfront payment of $300 million, with potential milestone payments of up to $100 million, totaling up to $400 million [1] - Surf Bio's hyperconcentration technology aims to enable high concentrations of therapeutics for subcutaneous delivery, enhancing patient experience [1] Business Development and Partnerships - In 2025, Halozyme signed three new ENHANZE collaboration and licensing agreements, along with one new auto-injector commercial licensing agreement and two development agreements [1] - The company anticipates having 15 partner programs in development by the end of 2026, further expanding its drug delivery portfolio [1]
Halozyme to Host Investor Conference Call to Provide Updated Financial Guidance and Business Update
Prnewswire· 2026-01-20 21:05
Core Insights - Halozyme Therapeutics, Inc. will host an Investor Conference Call on January 28, 2026, to discuss preliminary unaudited full year 2025 revenue results, updated financial guidance for 2026-2028, and a business update [1] Group 1: Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through innovative drug delivery solutions [3] - The company is known for its ENHANZE drug delivery technology, which facilitates subcutaneous delivery of injected drugs, impacting over one million patients through ten commercialized products across more than 100 global markets [3] - Halozyme has partnerships with leading pharmaceutical companies, including Roche, Takeda, Pfizer, and others, to utilize its drug delivery technology [3] Group 2: Product Development - Halozyme is developing Hypercon™, a microparticle technology aimed at enhancing drug concentration and reducing injection volume, which broadens the scope of therapeutics for subcutaneous delivery [4] - The company also focuses on drug-device combination products using advanced auto-injector technologies to improve patient comfort and adherence [5] - Halozyme has two proprietary commercial products, Hylenex and XYOSTED, along with partnered commercial products and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited [5] Group 3: Corporate Information - Halozyme is headquartered in San Diego, California, with additional offices in Ewing, New Jersey; Minnetonka, Minnesota; and Boston, Massachusetts [6]
Halozyme Announces Global Collaboration and License Agreement with Takeda to Develop and Commercialize Vedolizumab with ENHANZE®
Prnewswire· 2026-01-08 13:00
Core Insights - Halozyme Therapeutics has entered into a global collaboration and exclusive license agreement with Takeda for the use of its ENHANZE drug delivery technology with vedolizumab, marketed as ENTYVIO [1][2] - The collaboration aims to enhance patient experience by providing flexible treatment options for those with inflammatory bowel disease (IBD), specifically Crohn's disease and ulcerative colitis [2][3] Company Overview - Halozyme is a biopharmaceutical company focused on innovative solutions to improve patient experiences and outcomes, particularly through its ENHANZE drug delivery technology, which utilizes the proprietary enzyme rHuPH20 [5] - The ENHANZE technology has been validated commercially, impacting over one million patients through ten products across more than 100 global markets [5] - Halozyme is also developing Hyperconâ™, a microparticle technology aimed at reducing injection volume while expanding the range of therapeutics that can be delivered subcutaneously [6] Industry Context - Crohn's disease and ulcerative colitis are significant forms of IBD, with an estimated 10 million people expected to be living with IBD globally within the next decade, indicating a growing healthcare burden [3] - Vedolizumab (ENTYVIO) is a biologic therapy approved for both intravenous and subcutaneous administration for adults with moderately to severely active IBD [4]
U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with ENHANZE® for the Treatment of Advanced EGFR-mutated Non-Small Cell Lung Cancer
Prnewswire· 2025-12-18 12:00
Core Viewpoint - Halozyme Therapeutics announced that Johnson & Johnson received FDA approval for RYBREVANT FASPRO™, a subcutaneously administered targeted therapy for patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) [1][4]. Group 1: Product Approval and Benefits - RYBREVANT FASPRO™ is the first and only subcutaneously administered therapy for EGFR+ mNSCLC, approved across all indications of RYBREVANT® [1]. - Compared to intravenous (IV) delivery, RYBREVANT FASPRO™ significantly reduced administration time from several hours to approximately five minutes and demonstrated a fivefold reduction in administration-related reactions (ARRs) (13% in SC vs 66% in IV) [2]. - The approval highlights the role of ENHANZE technology in providing clinical and economic value for patients, healthcare providers, and payers [3]. Group 2: Clinical Study Results - RYBREVANT FASPRO™ met both co-primary pharmacokinetic (PK) endpoints in the Phase 3 PALOMA-3 study, demonstrating consistent results with RYBREVANT® [4]. Group 3: Company Overview and Technology - Halozyme is a biopharmaceutical company focused on improving patient experiences through innovative drug delivery solutions, particularly with its ENHANZE technology [6]. - The company is also developing Hypercon™, a microparticle technology aimed at enhancing drug concentration and reducing injection volume, which broadens the scope of therapeutics for subcutaneous delivery [7]. - Halozyme has commercialized ten products using ENHANZE technology, impacting over one million patients globally [6].
Jim Lang Elected to Halozyme's Board of Directors
Prnewswire· 2025-12-08 21:05
Company Overview - Halozyme Therapeutics, Inc. is a biopharmaceutical company focused on advancing disruptive solutions to improve patient experiences and outcomes for both emerging and established therapies [5] - The company is headquartered in San Diego, CA, with additional offices in Ewing, NJ; Minnetonka, MN; and Boston, MA [9] Leadership Appointment - Jim Lang has been elected to Halozyme's Board of Directors, bringing over 30 years of executive leadership experience in healthcare, life sciences, business services, and data analytics [1] - Dr. Helen Torley, president and CEO, expressed confidence in Mr. Lang's strategic insight and ability to drive growth, particularly through mergers and acquisitions [2] Previous Experience of Jim Lang - Mr. Lang previously served as CEO of EVERSANA, where he led the company’s growth through the acquisition of over twenty companies, culminating in a merger with Waltz Health in August 2025 [2] - He also transformed Decision Resources Group into a leading healthcare data and analytics firm through significant expansion and acquisitions [2] Current Board Positions - Mr. Lang serves on the board of Biovie, Inc., chairing both the Audit Committee and the Nominating and Corporate Governance Committee [3] - He is also on the board of OptimizeRx Corporation, acting as chair of the Compensation Committee [3] Strategic Vision - Mr. Lang expressed his honor in joining Halozyme's Board and highlighted the company's strong foundation and compelling growth strategy [4] - He aims to work with the leadership team to accelerate growth and enhance shareholder value [4] Product Innovations - Halozyme is known for its ENHANZE drug delivery technology, which facilitates subcutaneous delivery of injected drugs, improving patient convenience and reducing treatment burden [6] - The company is developing Hypercon™, an innovative microparticle technology expected to set a new standard in drug concentration, enhancing at-home and healthcare provider administration [7] - Halozyme also develops drug-device combination products using advanced auto-injector technologies to improve patient comfort and adherence [8]
Halozyme Wins Preliminary Injunction Against Merck's Keytruda SC in Germany
Prnewswire· 2025-12-04 18:26
Core Viewpoint - Halozyme Therapeutics has secured a preliminary injunction from a German court against Merck, preventing the distribution of Keytruda SC in Germany due to patent infringement concerns related to Halozyme's MDASE™ technology [1][2]. Legal Developments - The Munich Regional Court identified imminent infringement of Halozyme's European Patent No. 2 797 622 (EP 622) by Merck's Keytruda SC, leading to the injunction [2]. - Merck has initiated separate nullity proceedings against the patent in August 2025, which are currently pending [2]. - Halozyme is confident that the injunction will withstand any potential appeal by Merck [2]. Patient Access - Patients will still have access to the intravenous (IV) version of Keytruda, which is not affected by the injunction or Halozyme's patent [3]. Company Statements - Halozyme expressed satisfaction with the court's decision, emphasizing the validity of its MDASE patents and its commitment to defending them [4]. - The company is also pursuing patent infringement claims against Merck in the U.S. federal district court, alleging that the subcutaneous formulation of Keytruda marketed as QLEX infringes 15 of Halozyme's patents [4]. Patent and Technology Overview - The MDASE™ patents are distinct from Halozyme's ENHANZE licensing program, meaning the outcome of the lawsuit will not affect ENHANZE or its associated revenues [5]. - Halozyme's MDASE technology is based on extensive research into human hyaluronidases, which facilitate rapid subcutaneous drug delivery [4]. Company Profile - Halozyme is a biopharmaceutical company focused on innovative drug delivery solutions, with its ENHANZE technology having impacted over one million patients globally [6][7]. - The company is also developing Hypercon™, a microparticle technology aimed at enhancing drug concentration and delivery methods [8].
Halozyme to Participate in the 8th Annual Evercore Healthcare Conference
Prnewswire· 2025-11-25 13:30
Core Insights - Halozyme Therapeutics, Inc. will present at the 8th Annual Evercore Healthcare Conference on December 2, 2025, at 10:20 am PT / 1:20 pm ET, hosted by Dr. Helen Torley, the president and CEO [1] Company Overview - Halozyme is a biopharmaceutical company focused on innovative solutions to enhance patient experiences and outcomes for both emerging and established therapies [3] - The company is known for its ENHANZE® drug delivery technology, which utilizes the proprietary enzyme rHuPH20 to facilitate subcutaneous delivery of injected drugs, improving convenience and reducing treatment burden [4] - ENHANZE® has impacted over one million patients through ten commercialized products across more than 100 global markets, with partnerships involving major pharmaceutical companies such as Roche, Takeda, and Pfizer [4] Technology Development - Halozyme is developing Hypercon™, a microparticle technology aimed at hyper-concentration of drugs and biologics, which is expected to reduce injection volume while expanding at-home and healthcare provider administration opportunities [5] - The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Johnson & Johnson and Eli Lilly, enhancing the company's drug delivery capabilities [5] Product Portfolio - The company also develops drug-device combination products using advanced auto-injector technologies to improve patient comfort and adherence, with proprietary products like Hylenex® and XYOSTED® [6] - Halozyme has ongoing development programs in collaboration with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. [6] Corporate Information - Halozyme is headquartered in San Diego, California, with additional offices in Ewing, New Jersey; Minnetonka, Minnesota; and Boston, Massachusetts [7]
Halozyme Completes Acquisition of Elektrofi, Expanding Breadth of Offerings in Drug Delivery
Prnewswire· 2025-11-18 13:50
Core Insights - Halozyme Therapeutics has successfully completed the acquisition of Elektrofi, a biopharmaceutical company specializing in ultra-high concentration microparticle formulation technology for biologics, branded as Hypercon™ [1] Group 1: Acquisition Details - The acquisition follows the expiration of the Hart-Scott-Rodino waiting period and the satisfaction of all closing conditions [1] - The initial partner targets for Halozyme include derisked Mechanisms of Action (MoAs) that are currently approved blockbusters [1] Group 2: Future Projections - Royalty revenue contribution from the acquisition is expected to begin as early as 2030 [1] - Two of Elektrofi's partners are projected to start clinical development of Hypercon™ formulated products by the end of 2026 or earlier [1] Group 3: Business Model and IP - The licensing model is highly scalable with a long duration of intellectual property extending into the 2040s [1] - There is potential for individual product intellectual property extension through proprietary reformulation [1]