Achieved a record $1.4 billion in total revenue for 2025, a 38% increase driven by a 52% surge in royalty revenue from core blockbuster franchises. Transformed the corporate profile from two to four drug delivery technologies through the acquisitions of Elektrofi (Hypercon) and Surf Bio, extending IP protection into the mid-2040s. Performance was anchored by DARZALEX FASPRO, which now holds a 97% share of sales in the U.S., and PHESGO, which surpassed its initial 50% conversion target to reach 54%. ...

Financial Data and Key Metrics Changes - Total revenue for 2025 grew by 38% to $1.4 billion, with royalty revenue increasing by 52% to $868 million, reflecting strong performance from ENHANZE-enabled products [9][17] - Net income for the full year was $316.9 million, down from $444.1 million in 2024, impacted by a $285 million acquired IP R&D expense [19] - Adjusted EBITDA was $657.6 million, compared to $632.2 million in 2024, indicating operational strength despite the IP charge [19] Business Line Data and Key Metrics Changes - DARZALEX Subcutaneous generated $483 million in royalty revenue, a 29% year-over-year growth, with total sales reaching $14.4 billion [10] - PHESGO's royalty revenue increased by 51% to $105.6 million, with total sales growing 48% year-over-year to approximately $3 billion [11] - VYVGART and VYVGART Hytrulo saw a 444% year-over-year growth in royalty revenues to $157.2 million, with total sales reaching $4.15 billion [12] Market Data and Key Metrics Changes - ENHANZE now has 10 global blockbuster opportunities, with significant approvals in the U.S., Japan, and China for various products [8][16] - The subcutaneous formulations of Ocrevus, Opdivo, RYBREVANT, and Tecentriq represent a combined market opportunity of approximately $30 billion by 2028 [13] Company Strategy and Development Direction - The company aims to expand its ENHANZE pipeline, projecting 6 new programs to enter phase one in 2026, bringing the total development portfolio to 15 products [24] - The strategy includes pursuing additional licensing agreements and evaluating new drug delivery technologies to enhance long-term revenue streams [27][28] - Hypercon technology is expected to meet the demand for lower volume, auto-injector-ready therapies, with projections of approximately $1 billion in royalty revenue within five years of the first launches [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term trajectory of the company, emphasizing the durability of royalty revenue and the potential for exceptional value creation [23] - The company anticipates continued strong growth driven by existing products and new collaborations, with a focus on expanding into new therapeutic areas [25][36] Other Important Information - The company completed acquisitions of Elektrofi and Surf Bio, enhancing its drug delivery capabilities and extending IP into the mid-2040s [6][27] - The balance sheet was strengthened with the issuance of convertible notes and an upsized revolving credit facility, reducing near-term refinancing risk [21] Q&A Session Summary Question: Regarding the DARZALEX collaboration with J&J - Management expects to enter discussions with J&J to extend the agreement closer to its expiration in 2032, emphasizing the importance of the partnership [42] Question: On the ADC strategy and regulatory paths - The regulatory pathway for converting ADCs from IV to subcutaneous is expected to follow traditional PK non-inferiority studies, with additional trials for unapproved products [50] Question: Update on Hypercon products and clinical testing - Two Hypercon products are on track for phase 1 clinical testing in 2026, with completion of clinical scale-up batches and IND filings underway [66] Question: Potential incremental royalty opportunities from Merus's petosemtamab - Management highlighted the potential for expanded indications and the importance of subcutaneous formulations in enhancing patient treatment experiences [58]

Financial Data and Key Metrics Changes - Total revenue grew 38% to $1.4 billion, with royalty revenue increasing 52% to $868 million for the full year 2025 [9][17][19] - Net income for the full year was $316.9 million, compared to $444.1 million in 2024, while adjusted EBITDA was $657.6 million, up from $632.2 million in 2024 [19][20] - GAAP diluted EPS was $2.50, down from $3.43 in 2024, while non-GAAP diluted EPS was $4.15, compared to $4.23 in 2024 [19][20] Business Line Data and Key Metrics Changes - DARZALEX Subcutaneous generated $483 million in royalty revenue, a 29% year-over-year growth, with total sales reaching $14.4 billion [10][19] - Phesgo's royalty revenue increased 51% year-over-year to $105.6 million, with total sales growing 48% to approximately $3 billion [11][19] - VYVGART and VYVGART Hytrulo saw a 444% year-over-year growth in royalty revenues to $157.2 million, with total sales reaching $4.15 billion [12][19] Market Data and Key Metrics Changes - ENHANZE-enabled products now include 10 global blockbuster opportunities, with significant approvals in multiple markets including the U.S., Japan, and China [8][16] - The subcutaneous formulations of Ocrevus, Opdivo, RYBREVANT, and Tecentriq represent a combined market opportunity of approximately $30 billion by 2028 [13][16] Company Strategy and Development Direction - The company aims to expand its ENHANZE portfolio with six new programs entering phase I in 2026, bringing the total development portfolio to 15 products [24][35] - Hypercon technology is expected to meet the demand for lower volume, auto-injector-ready therapies, with projections of approximately $1 billion in royalty revenue within five years of the first launches [26][27] - The company plans to pursue strategic acquisitions to enhance its drug delivery portfolio while maintaining financial discipline [27][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term trajectory of the company, highlighting multiple revenue drivers and the durability of royalty revenue [23][39] - The company anticipates continued strong growth from existing products and new launches, with a focus on expanding into new therapeutic areas [24][35] Other Important Information - The company completed acquisitions of Elektrofi and Surf Bio, enhancing its drug delivery capabilities with long-duration IP [6][27] - The company expects to maintain a strong balance sheet and reduce net debt to below 1x by the end of 2026 [21][22] Q&A Session Summary Question: Regarding the mechanics of DARZALEX collaboration with J&J - Management expects to enter discussions with J&J to extend the agreement closer to its expiration in 2032, emphasizing the importance of the partnership [42][43] Question: On the ADC strategy and regulatory paths - Management indicated that the regulatory pathway for converting IV to subcutaneous delivery would likely follow traditional PK non-inferiority studies [49][50] Question: Update on Hypercon products and clinical testing - Management confirmed that two Hypercon products are on track for phase I clinical testing in 2026, with completion of clinical scale-up batches underway [63][64] Question: Expectations for new partnerships in auto-injectors - Management anticipates progress with high-volume auto-injectors and expects to see interest from both current and new partners [75][76]

Financial Data and Key Metrics Changes - Total revenue grew 38% to $1.4 billion, with royalty revenue increasing 52% to $868 million for the full year 2025 [7][15][17] - Net income for the full year was $316.9 million, compared to $444.1 million reported in 2024 [17] - Adjusted EBITDA was $657.6 million, compared to $632.2 million in 2024 [17] - GAAP diluted EPS was $2.50, compared with $3.43 in 2024, while non-GAAP diluted EPS was $4.15, compared with $4.23 in 2024 [17][18] Business Line Data and Key Metrics Changes - DARZALEX Subcutaneous generated $483 million in royalty revenues, representing 29% year-over-year growth, with total sales growing 22% to $14.4 billion [8][9] - PHESGO delivered $105.6 million in royalty revenue, reflecting 51% year-over-year growth, with total sales increasing 48% to approximately $3 billion [9][10] - VYVGART and VYVGART Hytrulo generated $157.2 million in royalty revenue, representing 444% year-over-year growth, with total sales growing 90% to $4.15 billion [10][11] Market Data and Key Metrics Changes - The company now has 10 ENHANZE-enabled global blockbuster opportunities, with significant approvals in the U.S., Japan, and China [6][12] - Roche reported that there are now 17,500 patients on Ocrevus Zunovo, a 5,000 patient increase from the third quarter [11] - Analysts project that PHESGO will reach CHF 3.6 billion in 2028, and Ocrevus franchise sales expectations have been increased to CHF 9 billion, or approximately $11.5 billion [10][12] Company Strategy and Development Direction - The company expanded its portfolio from two to four subcutaneous drug delivery technologies through acquisitions, positioning itself as a one-stop shop for biopharma subcutaneous drug delivery [5][6] - The focus is on advancing the ENHANZE pipeline, with projections for 6 new ENHANZE programs entering phase one in 2026 [21][32] - The company aims to continue strategic M&A to enhance its drug delivery portfolio and maintain financial discipline while investing in long-term value creation [24][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term trajectory of the company, highlighting multiple revenue drivers that will support durable royalty revenue [20][36] - The company anticipates continued strong growth from its existing blockbusters and new product launches, with a focus on expanding into new therapeutic areas [20][21] - Management expects to enter discussions with Johnson & Johnson to extend the DARZALEX collaboration agreement closer to its expiration in 2032 [39][40] Other Important Information - The company signed three new ENHANZE collaboration and licensing agreements, expanding its reach beyond oncology into obesity and inflammatory bowel disease [6][7] - The acquisition of Surf Bio is expected to enhance the company's hyperconcentration technology capabilities [24] - The company ended the year with a net debt to EBITDA ratio of 2.1x, with expectations to deleverage to below 1x by the end of 2026 [19] Q&A Session Summary Question: Can you elaborate on the mechanics of the DARZALEX collaboration with J&J? - Management expects to enter discussions with J&J to extend the agreement closer to its expiration in 2032, as they do not anticipate J&J seeking another source of API [39][40] Question: What are the regulatory paths for ADCs with ENHANZE? - The regulatory pathway for converting from IV to subcutaneous is expected to follow traditional PK non-inferiority studies, while additional benefits would require phase trials [46][47] Question: What is the progress on Hypercon products? - The company is on track to support two partners in advancing to phase 1 clinical testing in 2026, with clinical scale-up batches being completed [61][62] Question: How will sales from auto-injectors be reported? - Sales from auto-injectors will be recognized similarly to API sales, with royalties recognized on commercial sales [76]

Core Insights - Halozyme Therapeutics is expanding its portfolio with the acquisition of Hypercon and Surf Bio, enhancing its capabilities in subcutaneous (SC) drug delivery technologies [4][5][6] - The company expects significant revenue growth, with preliminary 2025 total revenue estimates between $1.385 billion and $1.4 billion, representing a 36% to 38% increase over 2024 [8] - Halozyme has raised its 2026 guidance, projecting total revenue between $1.71 billion and $1.81 billion, with royalty revenue between $1.13 billion and $1.17 billion [17] Acquisition and Technology Expansion - The acquisition of Surf Bio adds a second hyperconcentration technology, which is expected to be clinic-ready by the end of 2027 or early 2028 [4][7] - Hypercon technology is anticipated to be clinic-ready in 2026, with two partners expected to initiate Phase I studies by the end of 2026 [5][7] - The company now has three royalty-bearing SC delivery technologies, expanding its opportunity set into the mid-2040s [5][6] Financial Performance and Projections - Halozyme's 2025 royalty revenue is projected to be between $865 million and $870 million, reflecting a growth of 51% to 52% over 2024 [8] - For 2026, the company expects to exceed $1 billion in royalty revenue, a year earlier than previously projected [9] - Long-term projections indicate total revenue exceeding $2 billion by 2028, with royalty revenue between $1.46 billion and $1.51 billion, representing a CAGR of 26% to 28% from 2024 to 2028 [11] Product Development and Market Strategy - The company anticipates six new ENHANZE products entering Phase I in 2026, increasing the development portfolio to 13 products [13] - Major product drivers include DARZALEX and VYVGART Hytrulo, with projected sales of $14.3 billion and $4.15 billion respectively for 2025 [13] - Halozyme is exploring additional M&A opportunities to enhance its drug delivery technology and revenue growth [15] Profitability and Operational Efficiency - Halozyme aims for a gross margin above 80% and an operating margin greater than 60% during the 2026–2028 period [12] - The company projects free cash flow to exceed 70% of EBITDA, indicating a strong focus on operational efficiency [12]

Halozyme Therapeutics Investor Conference Call Summary Company Overview - **Company**: Halozyme Therapeutics (NasdaqGS: HALO) - **Date of Call**: January 28, 2026 - **Key Speaker**: Dr. Helen Torley, President and CEO Key Highlights Business Updates - **Acquisitions**: - Acquired Elektrofi in November 2025, gaining Hypercon technology for biologic hyperconcentration with IP extending to the mid-2040s [4][5] - Acquired Surf Bio in late December 2025, adding another hyperconcentration technology with similar long-duration IP [5] - **ENHANZE Technology**: - Continued strong momentum with global regulatory approvals for ENHANZE, co-formulated with Johnson & Johnson's RYBREVANT, leading to 10 globally approved products [5][6] - Three new collaboration agreements signed in late 2025, expanding therapeutic areas to include obesity and inflammatory bowel disease [6] Financial Performance - **2025 Revenue Estimates**: - Projected total revenue of $1.385 billion to $1.4 billion, representing a 36%-38% growth over 2024 [15] - Royalty revenue projected at $865 million to $870 million, a 51%-52% increase year-over-year [16] - **2026 Guidance**: - Total revenue projected at $1.71 billion to $1.81 billion, a 23%-30% increase over 2025 [17] - Royalty revenue guidance increased to $1.13 billion to $1.17 billion, reflecting a 30%-35% year-over-year increase [18] - **Long-term Projections**: - Total revenue expected to exceed $2 billion by 2028, driven by robust royalty revenue growth [19] Technology and Market Trends - **Subcutaneous Delivery**: - Halozyme's technologies address challenges in subcutaneous delivery of biologics, allowing larger volumes to be administered quickly [9][11] - Hypercon and Surf Bio technologies can achieve concentrations of up to 500 mg/mL, significantly reducing injection volumes [11][12] - **Emerging Opportunities**: - Interest in using ENHANZE with nucleic acids and antibody-drug conjugates, indicating a growing market for these applications [10][27] - **Market Dynamics**: - Shift towards at-home therapies and smaller volume injections is driving demand for Halozyme's technologies [29] Competitive Positioning - **Durability and Profitability**: - Halozyme's business model is asset-light, with partners responsible for development costs, leading to high margins and free cash flow [21] - Projected growth margin exceeding 80% and operating margin greater than 60% for 2026-2028 [21] Strategic Outlook - **Future Growth Drivers**: - Continued expansion of ENHANZE with 13 products in development by the end of 2026 [41] - Potential for additional M&A to enhance revenue streams and leverage Halozyme's expertise in drug delivery technologies [30][82] - **Regulatory Environment**: - FDA's evolving stance on clinical study designs may expedite approval timelines for new technologies [50][51] Additional Insights - **Partnerships and Collaborations**: - Ongoing discussions with biopharma companies for new licensing agreements, with expectations of signing 1-3 new ENHANZE deals in 2026 [41][42] - **Market Position**: - ENHANZE remains a key platform for Halozyme, with significant contributions expected from existing and new products [41][42] This summary encapsulates the critical points discussed during the Halozyme Therapeutics investor conference call, highlighting the company's strategic direction, financial performance, and market opportunities.

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]

Core Insights - Halozyme Therapeutics and Skye Bioscience have entered a non-exclusive global collaboration to develop a subcutaneous formulation of nimacimab for obesity treatment, utilizing Halozyme's ENHANZE drug delivery technology [1][2] - The collaboration aims to evaluate higher doses of nimacimab through larger injection volumes, with Skye planning to initiate a Phase 2b clinical trial in mid-2026 [3] Group 1: Collaboration Details - Skye has licensed Halozyme's ENHANZE technology to support the development and commercialization of nimacimab, which is intended to enhance treatment options for obesity [1][2] - Skye will make milestone payments based on the achievement of specific development and commercialization events, while Halozyme will receive mid-single digit royalties on net sales of nimacimab for at least 10 years [2] Group 2: Market Potential and Strategy - The collaboration expands Halozyme's ENHANZE technology into the obesity market, which is identified as having significant long-term potential [2] - Halozyme's strategy focuses on driving sustainable royalty growth through new partnerships and innovations, reinforcing the scalability of ENHANZE across various therapeutic indications [2] Group 3: Clinical Development Plans - Skye plans to assess the combination of nimacimab with a GLP-1 receptor agonist in the upcoming Phase 2b clinical trial, which will evaluate multiple dose-ranging strategies [3][9] Group 4: Company Background - Halozyme is a biopharmaceutical company that develops solutions to improve patient experiences and outcomes, with a focus on drug delivery technologies [4][5] - The ENHANZE technology has been validated commercially and is licensed to numerous leading pharmaceutical companies, enhancing its market presence [5] Group 5: Future Innovations - Halozyme is also developing Hypercon™, a microparticle technology aimed at reducing injection volumes while expanding the scope of therapeutics that can be delivered subcutaneously [6] - The company is engaged in developing drug-device combination products to improve patient comfort and adherence [7]

Core Insights - Investing in Halozyme Therapeutics offers exposure to the healthcare and biotechnology sectors, with the S&P 500 healthcare sector rising 13% compared to the broader index's 7% increase, while Halozyme's stock has decreased by 9% in the same period, presenting a buying opportunity [1] Company Overview - Halozyme Therapeutics has a market capitalization of $7 billion, with a current stock price of $63.33 and a gross margin of 78.83% [2] - The company is recognized for its ENHANZE technology, which facilitates subcutaneous drug delivery, serving over 1 million patients and significantly reducing delivery time for 97% of its patients [2] Financial Performance - Halozyme has achieved a 38% annualized sales growth rate over the last decade, indicating strong performance despite current stock valuation pressures due to upcoming patent expirations in the U.S. (2027) and EU (2029) [3] Strategic Acquisitions - The company has diversified its offerings through strategic acquisitions, including the recent $750 million acquisition of Elektrofi, enhancing its drug delivery capabilities with Hypercon technology, which extends intellectual property until 2040 [5] - In 2022, Halozyme acquired Antares Pharma for $960 million, adding autoinjector technology and enabling at-home self-administered therapies, further diversifying its product range [6] Investment Potential - Halozyme demonstrates a cash return on invested capital of 31%, effectively utilizing its free cash flow for acquisitions and share repurchases, with shares trading at 14 times free cash flow, suggesting resilience against the upcoming patent cliff [7]

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].