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Halozyme Therapeutics (NasdaqGS:HALO) Earnings Call Presentation
2025-10-01 12:30
Halozyme to Acquire Elektrofi Investor Conference Call Non-GAAP Financial Measures: NASDAQ: HALO October 1, 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 the assumptions used in deriving such guidance) including expectations for ...
Halozyme(HALO) - 2025 FY - Earnings Call Transcript
2025-09-04 18:32
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]
Halozyme(HALO) - 2025 FY - Earnings Call Transcript
2025-09-04 18:30
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]
Halozyme(HALO) - 2025 Q2 - Earnings Call Presentation
2025-08-05 20:30
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]
European Commission Approved DARZALEX Faspro® for Adult Patients with Smouldering Multiple Myeloma
Prnewswire· 2025-07-23 15:36
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]
Halozyme Therapeutics Added to Russell 1000® Index
Prnewswire· 2025-06-30 20:05
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]
Halozyme Announces argenx Received European Commission Approval for VYVGART® Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Prnewswire· 2025-06-20 17:15
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]
Halozyme to Participate at Upcoming Investor Conferences
Prnewswire· 2025-05-28 20:05
Company Overview - Halozyme Therapeutics, Inc. is a biopharmaceutical company focused on improving patient experiences and outcomes through innovative drug delivery solutions [2] - The company is known for its ENHANZE® drug delivery technology, which utilizes the proprietary enzyme rHuPH20 to facilitate subcutaneous delivery of drugs and fluids [2] - Halozyme has impacted over one million patients through its technology, which is used in ten commercialized products across more than 100 global markets [2] Product Development - Halozyme develops, manufactures, and commercializes drug-device combination products, leveraging advanced auto-injector technologies for improved convenience and patient adherence [3] - The company has two proprietary commercial products, Hylenex® and XYOSTED®, and is engaged in partnerships with Teva Pharmaceuticals and McDermott Laboratories Limited [3] Upcoming Events - Dr. Helen Torley, the president and CEO of Halozyme, will participate in investor meetings at the Benchmark 2025 Healthcare House Call Virtual Conference on May 29, 2025 [1] - The company will also be featured at the Goldman Sachs 46th Annual Global Healthcare Conference on June 9, 2025, with a presentation scheduled for 7:00 am PT / 10:00 am ET [1] - Live audio webcasts of the presentations will be available on the company's Investor Relations website, with replays accessible for 90 days post-conference [1]
Halozyme Announces Bristol Myers Squibb Received European Commission Approval for Subcutaneous Opdivo® (nivolumab) Co-Formulated with ENHANZE® Across Multiple Solid Tumor Indications
Prnewswire· 2025-05-28 12:30
Group 1 - Halozyme Therapeutics announced that Bristol Myers Squibb received European Commission approval for a new subcutaneous formulation of Opdivo® (nivolumab) for multiple adult solid tumors [1][2] - The subcutaneous injection of Opdivo® can be administered in 3 to 5 minutes, providing a more convenient option for cancer patients [2] - The approval is valid across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway [3] Group 2 - The positive decision from the European Commission is supported by results from the Phase 3 CheckMate -67T trial [2] - Halozyme's ENHANZE® technology, which facilitates subcutaneous drug delivery, has been licensed to several leading pharmaceutical companies [4] - Halozyme has impacted over one million patients through its commercialized products and aims to improve patient experiences with rapid subcutaneous delivery [4]
HALOZYME RAISES 2025 FINANCIAL GUIDANCE RANGES AND REPORTS STRONG FIRST QUARTER 2025 RESULTS
Prnewswire· 2025-05-06 20:01
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]