Accessibility StatementSkip Navigation SAN DIEGO, Nov. 25, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Dr. Helen Torley, president and chief executive officer, will present and host investor meetings at the 8th Annual Evercore Healthcare Conference. The presentation is scheduled for Tuesday, December 2 at 10:20am PT / 1:20pm ET. A live audio webcast will be available on the Investor Relations section of the Company's website. Replays of the audio webc ...

Core Insights - Halozyme Therapeutics announced FDA approval for DARZALEX Faspro® as the first treatment for high-risk smoldering multiple myeloma (HR-SMM), allowing earlier intervention before progression to active multiple myeloma [1][2][3] Company Overview - Halozyme is a biopharmaceutical company focused on innovative solutions to enhance patient experiences and outcomes, particularly through its ENHANZE® drug delivery technology [4] - The company has successfully licensed its ENHANZE® technology to major pharmaceutical companies, including Roche, Takeda, and Pfizer, among others [4] Market Context - In 2025, over 36,000 individuals are expected to be diagnosed with multiple myeloma in the U.S., with approximately 15% classified as smoldering [2] - About 50% of patients diagnosed with HR-SMM are likely to progress to active disease within two years, highlighting the need for effective early treatment options [2] Clinical Study - The FDA approval was based on the AQUILA study, the largest Phase 3 trial evaluating DARZALEX Faspro® against active monitoring in HR-SMM patients [3]

Halozyme Therapeutics, Inc. Third Quarter Financial & Operating Results NASDAQ: HALO November 3, 2025 1 Forward-Looking Statements 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 and growth rates (including the Company's 2025 financial guidance and longer term financial outlook through 2028 and the assumptions used in deriving such g ...

Transaction Summary - Halozyme 将收购 Elektrofi，总交易额为 7.5 亿美元[15]，外加 1.5 亿美元的或有里程碑付款[15]。 - Elektrofi 的 Hypercon 技术可以将生物制剂浓度提高到比当前行业标准水溶液配方高 4-5 倍[9]。 - 该交易预计在 2025 年第四季度完成[15]，对中期非 GAAP 摊薄后每股收益的稀释小于 5%[15]。 - 收购 Elektrofi 将扩大 Halozyme 在创新药物递送技术方面的视野和广度[9]。 - 预计 Hypercon 配方产品的临床开发将于 2026 年底或更早开始[13]，并预计 2030 年开始贡献特许权使用费收入[14]。 Financial Performance and Guidance - Halozyme 重申了 2025 年全年指导范围[15]，总收入为 12.75 亿至 13.55 亿美元[57]，其中特许权使用费收入为 8.25 亿至 8.6 亿美元[57]。 - 预计调整后的 EBITDA 为 8.65 亿至 9.15 亿美元[57]，非 GAAP 摊薄后每股收益为 6.00 美元至 6.40 美元[57]。 - 预计 2026 财年的增量运营费用约为 5500 万美元[15]。 Technology and Growth - Halozyme 正在扩展其产品组合，包括 ENHANZE® 和 Hypercon 等专有技术[21, 22]。 - Hypercon 的知识产权将持续到 2040 年代[9]，支持长期收入增长[45]。 - Halozyme 预计将通过与现有和新的生物制药合作伙伴合作，扩大合作和收入机会[9]。

Financial Data and Key Metrics Changes - The company raised its revenue guidance for FY 2025 to $1.3 billion, with royalties from the ENHANZE® platform expected to be between $825 million and $860 million, representing a year-over-year growth of 46% to 51% [5][6] - EBITDA is projected to be at least $865 million, indicating a growth in the high 30% range [6] - The company has returned $1.8 billion to shareholders through share repurchases since 2019, including $303 million in the current year [7] Business Line Data and Key Metrics Changes - The ENHANZE® platform has achieved 10 approvals to date, with significant contributions from products launched between 2020 and 2023, including Darzalex® subcutaneous, VYVGART® Hytrulo, and Fesgo® [4][6] - VYVGART® Hytrulo has shown remarkable growth, achieving $1 billion in revenue in the second quarter, with a 100% year-over-year growth driven by its subcutaneous launch [10][11] - The company anticipates additional launches for Opdivo®, Tecentriq®, Ocrevus®, and Rybrevant®, which are expected to contribute meaningfully in 2026 and beyond [6][12] Market Data and Key Metrics Changes - The company is experiencing strong adoption of its subcutaneous delivery technology, with Darzalex® growing at 20% year-over-year and projected to reach $18 billion by 2028 [10] - Ocrevus® subcutaneous has already treated 6,500 patients worldwide, with 50% being new to the drug, indicating market expansion [17] Company Strategy and Development Direction - The company is focused on expanding its delivery platforms and exploring new partnerships, particularly in oncology, inflammation, immunology, neurology, and nephrology [23][24] - Halozyme is actively pursuing new deals and expects to sign at least one additional deal this year, which should progress into clinical trials next year [46] - The company is also looking for new drug delivery platforms that align with its revenue profiles to enhance growth [56] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued strong revenue growth driven by multiple catalysts, including new product approvals and market expansions [54] - The company is confident in its ability to influence policy discussions regarding the Inflation Reduction Act and its potential impact on revenue [30][31] - Management highlighted the importance of ongoing litigation with Merck, which could result in additional revenue streams if successful [37][40] Other Important Information - The company has a robust pipeline with nine products in development, including two in phase three trials, which could provide additional growth opportunities [47] - The co-formulation patent for VYVGART® Hytrulo could extend royalties until 2042, indicating a long revenue tail for the product [51] Q&A Session Summary Question: How is the long-term growth outlook for VYVGART® Hytrulo? - Management indicated that VYVGART® Hytrulo has significant growth potential, with ongoing studies to expand its indications and a strong market presence [12][11] Question: What is the launch trajectory for PD-1s like Opdivo® and Tecentriq®? - Management noted that Opdivo® is seeing good adoption, with a five-minute subcutaneous injection being attractive to physicians and patients [15][14] Question: How is the company addressing the Inflation Reduction Act? - Management is actively engaging with policy discussions and believes that the clinical benefits of their subcutaneous delivery technology will be recognized [26][30] Question: Can you provide an update on the Merck litigation? - Management confirmed that they are pursuing legal action against Merck for patent infringement and are confident in their position [36][37]

Financial Data and Key Metrics Changes - The company raised its revenue guidance for FY 2025 to $1.3 billion, with royalties from the ENHANZE® platform expected to be between $825 million and $860 million, representing a year-over-year growth of 46% to 51% [5][6] - EBITDA is projected to be at least $865 million, indicating a growth in the high 30% range [6] - The company has returned $1.8 billion to shareholders through share repurchases since 2019, including $303 million in the current year [7] Business Line Data and Key Metrics Changes - The ENHANZE® platform has achieved 10 approvals to date, with significant contributions from products launched between 2020 and 2023, including Darzalex® subcutaneous, VYVGART® Hytrulo, and Fesgo® [4][6] - VYVGART® Hytrulo has shown remarkable growth, achieving $1 billion in revenue in the second quarter with a 100% year-over-year growth rate [10][11] - The company anticipates additional launches for Opdivo®, Tecentriq®, Ocrevus®, and Rybrevant®, which are expected to contribute meaningfully starting in 2026 [6][12] Market Data and Key Metrics Changes - The company is experiencing strong adoption of its subcutaneous delivery technology, with Darzalex® growing at 20% year-over-year and projected to reach $18 billion by 2028 [10] - Ocrevus® subcutaneous is expected to expand the market by $2 billion, with 50% of patients being new to the drug [17] - The company is actively pursuing partnerships in oncology, inflammation, immunology, neurology, and nephrology, focusing on subcutaneous delivery opportunities [22] Company Strategy and Development Direction - The company aims to enhance patient convenience through at-home delivery of biologics, aligning with industry trends [5] - There is a focus on expanding the ENHANZE® platform and exploring new drug delivery technologies to drive growth [58] - The company is also looking for M&A opportunities to add new delivery platforms that align with its revenue model [58] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of royalty revenues, driven by multiple product catalysts and new indications [56] - The company is optimistic about the potential for new partnerships and product advancements, which will contribute to durable revenue growth [51][58] - Management is actively engaging with regulatory bodies to clarify the implications of the Inflation Reduction Act on their products [25][30] Other Important Information - The company is involved in litigation with Merck regarding patent infringement related to modified hyaluronidases, with potential for significant financial outcomes depending on the court's decision [36][37] - The company has a robust pipeline with nine products in development, including two in phase three trials, which could provide additional revenue streams [49][50] Q&A Session Summary Question: How is the long-term growth outlook for VYVGART® Hytrulo? - Management highlighted that VYVGART® Hytrulo has significant growth potential, with ongoing studies to expand its indications and a strong market presence [11][12] Question: What is the launch trajectory for PD-1s like Opdivo® and Tecentriq®? - Management indicated that Opdivo® is seeing good adoption, with a five-minute subcutaneous injection being attractive to physicians and patients [15][16] Question: How is the company addressing the Inflation Reduction Act? - Management is actively seeking to influence policy discussions and believes that their products will not be adversely affected by the IRA [25][30] Question: Can you provide an update on the Merck litigation? - Management explained that the litigation is ongoing, with expectations for a lengthy process, but expressed confidence in their position regarding patent infringement [36][37] Question: What are the timelines for new partnerships and product developments? - Management is optimistic about signing at least one new deal this year, with several products in the pipeline expected to progress into clinical trials [48][49]

Second Quarter 2025 Financial Results - Total revenue reached $325.7 million, a 41% increase compared to the second quarter of 2024[32] - Royalty revenue increased by 65% to $205.6 million[32] - Net income was $165.2 million, a 77% increase year-over-year[32] - Adjusted EBITDA was $225.5 million, a 65% increase compared to the same period last year[32] - GAAP diluted EPS increased by 85% to $1.33, while Non-GAAP diluted EPS increased by 69% to $1.54[32] Full Year 2025 Guidance - Total revenue is projected to be between $1.275 billion and $1.355 billion, representing a 26-33% increase[6] - Royalty revenue is expected to be between $825 million and $860 million, a 44-51% increase[6] - Adjusted EBITDA is guided to be between $865 million and $915 million, a 37-45% increase[6] - Non-GAAP diluted EPS is projected to be between $6.00 and $6.40, a 42-51% increase[6] Share Repurchase Program - The company completed a $250 million accelerated share repurchase program[6] - A new $250 million share repurchase program was announced[6]

Core Insights - Halozyme Therapeutics announced the European Commission approval for DARZALEX Faspro® (daratumumab) co-formulated with ENHANZE® for treating high-risk smouldering multiple myeloma (SMM) [1][2] - This approval marks a significant advancement in early intervention strategies for multiple myeloma, addressing critical patient needs [2] Company Overview - Halozyme is a biopharmaceutical company focused on innovative solutions to enhance patient experiences and outcomes, particularly through its ENHANZE® drug delivery technology [4] - The company has successfully licensed its ENHANZE® technology to major pharmaceutical firms, including Roche, Takeda, and Pfizer, among others [4] - Halozyme has two proprietary commercial products, Hylenex® and XYOSTED®, and is involved in ongoing product development with various partners [5] Clinical Study Insights - The EC approval is based on data from the Phase 3 AQUILA study, which compared the efficacy and safety of daratumumab SC monotherapy against active monitoring in high-risk SMM patients [3]

Group 1 - Halozyme Therapeutics, Inc. has been added to the U.S. large-cap Russell 1000® Index, effective after market close on June 27, 2025, as part of the 2025 FTSE Russell indexes annual reconstitution [1][2] - The Russell 1000® Index includes approximately 1,000 of the largest U.S. securities based on market capitalization and serves as a benchmark for large-cap stock performance [1][2] - Dr. Helen Torley, President and CEO of Halozyme, stated that joining the Russell 1000 Index reflects the company's leadership in rapid large-volume subcutaneous drug delivery and its track record of durable growth [2] Group 2 - 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 [3] - The company has licensed its ENHANZE® technology to major pharmaceutical companies, including Roche, Takeda, and Pfizer, impacting over one million patients globally [3][4] - Halozyme develops drug-device combination products using advanced auto-injector technologies aimed at enhancing patient comfort and adherence [4] Group 3 - The company is headquartered in San Diego, CA, with additional offices in Ewing, NJ, and Minnetonka, MN, where its operations facility is located [5]

Core Insights - The European Commission has approved VYVGART® (efgartigimod alfa) for subcutaneous injection as a monotherapy for adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins [1][4] - VYVGART is the first targeted IgG Fc-antibody fragment for CIDP and introduces a novel mechanism of action for CIDP treatment in over 30 years [2] - The approval is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date, and is valid across all 27 EU Member States, as well as Iceland, Norway, and Liechtenstein [4] Company Overview - Halozyme Therapeutics, Inc. specializes in biopharmaceutical solutions aimed at improving patient experiences and outcomes, particularly through its ENHANZE® drug delivery technology [5] - The company has impacted over one million patients through its commercialized products and has licensed its ENHANZE® technology to major pharmaceutical companies including Roche, Takeda, and Pfizer [5] - Halozyme also develops drug-device combination products using advanced auto-injector technologies to enhance patient comfort and adherence [6] Strategic Partnerships - The approval of VYVGART represents a significant milestone in Halozyme's partnership with argenx, expanding access to CIDP treatment in Europe [3] - The company continues to collaborate with various pharmaceutical and biotechnology firms to leverage its ENHANZE® technology for improved drug delivery [5][6]