UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-32335 _______________________________________ HALOZYME THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) ...

Financial Performance - Total revenue for Q1 2025 increased by 35% year-over-year to $265 million, with royalty revenue rising by 39% to $168 million[1] - Net income for Q1 2025 rose by 54% year-over-year to $118 million, while adjusted EBITDA increased by 40% to $162 million[1] - Total revenues for Q1 2025 reached $264.861 million, a 35.2% increase from $195.879 million in Q1 2024[22] - Royalty revenues increased to $168.192 million in Q1 2025, up 39.6% from $120.593 million in Q1 2024[22] - Net income for Q1 2025 was $118.095 million, representing a 53.5% increase compared to $76.823 million in Q1 2024[22] - Adjusted EBITDA for Q1 2025 was $161.983 million, compared to $115.748 million in Q1 2024, reflecting a 39.9% growth[26] - GAAP diluted earnings per share (EPS) for Q1 2025 was $0.93, up from $0.60 in Q1 2024, marking a 55% increase[28] Financial Guidance - The company raised its 2025 financial guidance for total revenue to a range of $1,200 million to $1,280 million, representing year-over-year growth of 18% to 26%[1] - Adjusted EBITDA guidance for 2025 is now set at $790 million to $840 million, indicating growth of 25% to 33% over 2024[1] - Non-GAAP diluted EPS guidance for 2025 has been increased to a range of $5.30 to $5.70, reflecting growth of 25% to 35% year-over-year[1] Share Repurchase Program - The company announced a new $250 million share repurchase program, in addition to the previous $750 million approved program[6] - The company has outlined potential share repurchases under its share repurchase program, reflecting confidence in its financial performance[18] Product Development and Growth Opportunities - Recent product launches, including Ocrevus Zunovo and Tecentriq Hybreza, are expected to contribute to future revenue growth as partners expand coverage and reimbursement[2] - The company signed its first HVAI development agreement with an ENHANZE partner, indicating ongoing collaboration and innovation in product development[3] - The company is pursuing multiple new product approvals and reimbursement milestones, creating additional growth opportunities in the near and long term[2] - The company anticipates continued growth in royalty and milestone payments driven by partner collaborations and product launches[18] - The company is focused on the development of its ENHANZE drug delivery technology, which is expected to enhance the delivery of injectable medications[18] Cash and Assets - Cash, cash equivalents, and marketable securities increased to $747.9 million as of March 31, 2025, up from $596.1 million at the end of 2024[9] - Cash and cash equivalents increased to $176.328 million as of March 31, 2025, compared to $115.850 million at the end of 2024[24] - Total assets grew to $2.197 billion as of March 31, 2025, up from $2.063 billion at the end of 2024, indicating a 6.5% increase[24]

Core Insights - Halozyme Therapeutics reported a strong financial performance for Q1 2025, with total revenue increasing by 35% year-over-year to $265 million, driven by a 39% increase in royalty revenue to $168 million [1][8] - The company announced a new $250 million share repurchase program, part of a larger $750 million initiative approved in February 2024 [6][2] - Halozyme raised its financial guidance for 2025, projecting total revenue between $1,200 million and $1,280 million, representing year-over-year growth of 18% to 26% [1][11] Financial Performance - Net income for Q1 2025 increased by 54% year-over-year to $118 million, with adjusted EBITDA rising by 40% to $162 million [1][8] - GAAP diluted EPS rose by 55% year-over-year to $0.93, while non-GAAP diluted EPS increased by 41% to $1.11 [1][8] - Cash, cash equivalents, and marketable securities totaled $747.9 million as of March 31, 2025, up from $596.1 million at the end of 2024 [8] Product and Pipeline Developments - The company highlighted strong growth from its three blockbuster brands: Darzalex SC, Phesgo, and VYVGART Hytrulo, along with contributions from four recently launched products [2][3] - Halozyme's pipeline includes two products in Phase 3 trials, with ongoing development and progress reported by partners [3][2] - Recent approvals and positive opinions from regulatory bodies for various products are expected to create additional growth catalysts [6][9] Corporate Activities - Halozyme filed a patent infringement lawsuit against Merck for alleged use of its MDASE™ technology in developing Subcutaneous Keytruda [6] - The company completed its first $250 million accelerated share repurchase under the approved program in March 2025 [6][2] - Recent corporate highlights include positive regulatory developments for Phesgo® and VYVGART® in Europe and the U.S. [6][9]

Company Overview - Halozyme Therapeutics, Inc. is a biopharmaceutical company focused on advancing disruptive 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 and fluids, aiming to improve patient experience through rapid delivery and reduced treatment burden [3] - Halozyme has impacted one million patient lives through post-marketing use of ten commercialized products across more than 100 global markets [3] Product and Technology - Halozyme has licensed its ENHANZE® technology to major pharmaceutical and biotechnology companies, including Roche, Takeda, Pfizer, and AbbVie, among others [3] - The company also develops and commercializes drug-device combination products using advanced auto-injector technologies, which offer advantages such as improved convenience, reliability, and patient comfort [4] - Halozyme has two proprietary commercial products, Hylenex® and XYOSTED®, and is engaged in ongoing product development programs with partners like Teva Pharmaceuticals and McDermott Laboratories Limited [4] Upcoming Events - Dr. Helen Torley, the president and CEO of Halozyme, will present and host investor meetings at the BofA Securities 2025 Healthcare Conference on May 13, 2025, at 4:20 PM PT / 7:20 PM ET [1] - A live audio webcast of the presentation will be available on the company's Investor Relations website, with replays accessible for 90 days post-conference [2]

Core Insights - The article emphasizes the importance of long-term wealth creation through value growth investing, value investing, and dividend investing [1] - The author expresses a commitment to writing articles focused on fundamental value investing, aiming to identify great companies at fair prices [1] Group 1 - The author has over 7 years of investing experience, primarily focusing on long-term strategies [1] - The educational background of the author is in Biology, specifically molecular cell biology, which informs their analytical approach to investing [1] - The articles will be based on personal experience, research, and literature related to building long-term wealth [1] Group 2 - The author has a beneficial long position in HALO shares, indicating a personal investment interest [2] - The article reflects the author's opinions and is not influenced by compensation from any company mentioned [2] - There is no business relationship with any company whose stock is discussed in the article [2]

Company Overview - Halozyme Therapeutics, Inc. is a biopharmaceutical company focused on improving patient experiences and outcomes through innovative solutions [3] - The company is known for its ENHANZE® drug delivery technology, which utilizes the proprietary enzyme rHuPH20 to facilitate subcutaneous delivery of drugs and fluids [3] - Halozyme has impacted over one million patients through its technology, which is used in ten commercialized products across more than 100 global markets [3] Product Development - Halozyme develops, manufactures, and commercializes drug-device combination products, leveraging advanced auto-injector technologies to enhance convenience, reliability, and patient comfort [4] - The company has two proprietary commercial products: Hylenex® and XYOSTED®, along with partnered products and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited [4] Upcoming Financial Results - Halozyme will release its first quarter 2025 financial and operating results on May 6, 2025, after the market closes [1] - A conference call to discuss these results will take place on the same day at 1:30 p.m. PT/4:30 p.m. ET, with live access available through pre-registration [1][2]

Core Insights - Halozyme Therapeutics, Inc. announced that argenx received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending European Commission (EC) approval of VYVGART® 1000mg for treating chronic inflammatory demyelinating polyneuropathy (CIDP) [1][4] - VYVGART® is the first targeted IgG Fc-antibody fragment for CIDP and represents the first novel mechanism of action for CIDP treatment in over 30 years [2] - The CHMP recommendation is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date [4] Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through its ENHANZE® drug delivery technology, which facilitates subcutaneous delivery of injected drugs [5] - The company has licensed its ENHANZE® technology to major pharmaceutical companies including Roche, Takeda, and Pfizer, impacting over one million patients globally [5] - Halozyme also develops drug-device combination products aimed at enhancing patient comfort and adherence [6] Market Implications - The EC decision on the marketing authorization application is expected within approximately two months, which will apply to all 27 EU Member States and additional countries [1][4] - The approval of VYVGART® could provide a groundbreaking treatment option for patients with rare autoimmune diseases across Europe [3]

智通财经APP获悉，生物科技公司Halozyme Therapeutics Inc.(HALO.US)起诉默沙东(MRK.US)，试图阻 止其推出更易使用的重磅抗癌药Keytruda新剂型，指控这家制药巨头侵犯其知识产权。 根据周四向美国新泽西地区法院提交的诉讼文件，默沙东在开发可皮下注射版Keytruda(替代静脉输注 剂型)时，故意侵犯了Halozyme的专利。Halozyme要求法院禁止新版Keytruda的商业化上市——该产品 预计将于今年晚些时候推出。 Keytruda在2024年为默沙东创造近300亿美元收入，已成为癌症治疗的基石和制药史上最畅销产品。但 这款占默沙东近半数营收的药物，预计将在2028年面临低价竞争和政府定价谈判。默沙东计划在该剂型 获批后尽快让患者转换用药，这意味着任何上市延迟都可能打乱公司的长期规划。 Halozyme首席执行官海伦·托利今年3月表示，公司希望与默沙东达成授权协议，仅当计划落空时才会采 取法律行动。 皮下注射剂型对默沙东的未来增长至关重要。该公司未立即回应就诉讼置评的请求。默沙东此前曾表 示，认为Halozyme相关专利无效，并对自身法律立场充满信心。为开发注射 ...

Core Viewpoint - Halozyme Therapeutics has filed a patent infringement lawsuit against Merck, alleging that Merck's development of subcutaneous Keytruda infringes on Halozyme's patented MDASE technology [1][2][5] Company Overview - Halozyme is a biotechnology company that specializes in subcutaneous drug delivery using human hyaluronidase, with a focus on improving patient outcomes through innovative drug delivery solutions [1][6] - The company has developed the ENHANZE® drug delivery technology, which facilitates rapid subcutaneous delivery of therapeutic drugs, and has partnered with major pharmaceutical companies to enhance patient experiences [6][8] Patent Infringement Details - Halozyme claims that Merck has used its MDASE technology without permission to develop subcutaneous Keytruda, which has completed phase 3 clinical testing and is expected to launch in 2025 [2][3] - The lawsuit seeks damages and injunctive relief to prevent Merck from launching SC Keytruda, as Halozyme believes Merck is aware of the infringement [5][6] Research and Development - Halozyme's patents stem from extensive research involving nearly 7,000 modifications to human hyaluronidases, which enable rapid subcutaneous administration of therapeutic drugs [4] - The company's innovations in hyaluronidases represent significant advancements in the field, providing a roadmap for enhancing drug delivery mechanisms [4] Legal Context - Halozyme's Chief Legal Officer stated that Merck's actions indicate a clear infringement of Halozyme's patents, and the lawsuit aims to enforce these rights without affecting Halozyme's existing ENHANZE® licensing program [5][6]

Core Insights - Halozyme Therapeutics, Inc. announced that argenx received FDA approval for VYVGART® Hytrulo prefilled syringe for self-injection, targeting adult patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) [1][2] Group 1: Product Details - VYVGART® Hytrulo is designed for a 20-to-30-second subcutaneous injection, allowing self-administration by patients or caregivers after proper training [2] - The approval is based on studies demonstrating bioequivalence to the vial version of VYVGART® and successful administration by participants in human factors validation studies [2] Group 2: Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences through its ENHANZE® drug delivery technology, which facilitates rapid subcutaneous delivery of biologics [3] - The company has impacted over one million patients globally through its technology, which is licensed to major pharmaceutical companies including Roche, Takeda, and Pfizer [3] Group 3: Additional Products and Technologies - Halozyme also develops drug-device combination products using advanced auto-injector technologies aimed at enhancing patient comfort and adherence [4] - The company has two proprietary commercial products, Hylenex® and XYOSTED®, and is engaged in ongoing development with partners like Teva Pharmaceuticals [4]