Workflow
ENHANZE
icon
Search documents
Halozyme Announces Global Collaboration and License Agreement with Takeda to Develop and Commercialize Vedolizumab with ENHANZE®
Prnewswire· 2026-01-08 13:00
®Agreement provides Takeda with exclusive access to ENHANZE drug delivery technology for vedolizumab ® SAN DIEGO, Jan. 8, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced the Company entered into a global collaboration and exclusive license agreement with Takeda in December 2025. The agreement provides Takeda with access to Halozyme's ENHANZE drug delivery technology, the leading proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20), for use with vedolizumab. Vedol ...
Halozyme and Skye Bioscience Announce Global Collaboration and License Agreement to Evaluate Nimacimab Co-Formulated with ENHANZE® for Obesity
Globenewswire· 2026-01-05 12:00
Agreement supports development and commercialization of higher-dose, subcutaneous administration strategies for nimacimabSAN DIEGO, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) and Skye Bioscience, Inc. (Nasdaq: SKYE) today announced the companies entered into a non-exclusive global collaboration and license agreement in December 2025. Under the collaboration, Skye has licensed Halozyme's ENHANZE® drug delivery technology for the development and potential commercialization of ...
The Healthcare Sector Is Surging. Here's 1 Stock Every Investor Should Have on Their Radar.
The Motley Fool· 2025-12-06 14:30
Investing in Halozyme Therapeutics is a compelling way to gain exposure to the broader healthcare and biotechnology industries.Over the last three months, the S&P 500 healthcare sector has risen 13%, compared to the broader S&P 500 index's 7% increase. However, one stock that hasn't matched its sector's returns is Halozyme Therapeutics (HALO +0.60%). Down 9% over the last few months, here's why Halozyme is a great buy right now.NASDAQ : HALOHalozyme TherapeuticsToday's Change( 0.60 %) $ 0.38Current Price$ 6 ...
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 Therapeutics, Inc. (HALO) Presents at Evercore 8th Annual Healthcare Conference Transcript
Seeking Alpha· 2025-12-02 20:43
PresentationBefore we delve into Q&A, I'd love to get your overview of the business and maybe key things to look forward to in the next 12 months or so.Okay. Let's get started. Welcome, everybody. Welcome to our conference in Miami. I had the pleasure of having Dr. Helen Torley, CEO of Halozyme Therapeutics. Helen, welcome. Thanks so much for making time for us.Helen TorleyPresident, CEO & Director That's great. Well, thanks for the invitation, Mike. Pleased to be here. This really is an incredibly exciting ...
Halozyme Therapeutics (NasdaqGS:HALO) FY Conference Transcript
2025-12-02 19:22
Halozyme Therapeutics FY Conference Summary Company Overview - **Company**: Halozyme Therapeutics (NasdaqGS: HALO) - **Event**: FY Conference held on December 02, 2025 - **Key Speaker**: Dr. Helen Torley, CEO Core Business and Technologies - Halozyme is experiencing significant adoption of its technologies, particularly with argenx's VYVGART Hytrulo and the success of DARZALEX SubQ, where 96% of patients in the US utilize the SubQ version [2][4] - The recent acquisition of Elektrofi for its HyperCon technology aims to enhance home delivery of biologic therapies through autoinjectors, expanding Halozyme's portfolio to three leading technologies [2][5] Financial Performance - Halozyme has raised its revenue guidance to $1.3-$1.375 billion, driven by a 50% year-over-year growth in royalties, expected to reach $850-$880 million [4] - EBITDA is projected to grow nearly 50%, reaching between $880 million and $930 million [4] Product Portfolio and Future Growth - Key products driving revenue include DARZALEX, PHESGO, and VYVGART Hytrulo, with expectations for new products like SubQ OCREVUS, OPDIVO, TECENTRIQ, and RYBREVANT to contribute significantly in the coming years [6][7] - DARZALEX is projected to grow from $14-$15 billion this year to $18 billion by 2028, with over 90% of its use being SubQ with ENHANZE [8] - PHESGO is expected to grow to $3-$3.5 billion, while VYVGART Hytrulo is anticipated to reach $4 billion, with projections of $8 billion based on current indications [9] Regulatory Environment and IRA Impact - Concerns regarding the IRA price negotiation have been downplayed, with Halozyme confident that its products will not be significantly impacted due to their classification and the presence of biosimilars [11][14] - The One Big Beautiful Bill Act clarifies that products with multiple orphan indications will not be included in IRA negotiations, benefiting Halozyme's portfolio [12][13] Elektrofi Acquisition Insights - The acquisition of Elektrofi is seen as timely, as the company has secured major deals and is at a value inflection point with products expected to enter clinical trials soon [16][17] - HyperCon technology allows for higher concentration drug delivery, with IP protection extending to the mid-2040s, providing additional revenue opportunities [18][19] Litigation and Patent Portfolio - Halozyme is currently in litigation with Merck regarding its MDASE patent portfolio, which is separate from its ENHANZE portfolio, ensuring no risk to ENHANZE royalties [23][24] - The company is pursuing a permanent injunction and triple damages in the litigation, while remaining open to licensing agreements with Merck [24] Strategic Partnerships and Deal Structure - Halozyme is shifting towards non-exclusive deals for bispecific products, allowing for greater flexibility and collaboration with multiple partners [27][28] - The company aims to continue adding new products and royalty streams to sustain its growth trajectory [10][29] Conclusion - Halozyme is positioned for strong growth driven by its ENHANZE technology and the new HyperCon technology, with a robust pipeline of products and a favorable regulatory outlook [29][30]
Halozyme(HALO) - 2025 Q3 - Earnings Call Transcript
2025-11-03 22:30
Financial Data and Key Metrics Changes - The company reported record royalty revenue of $236 million, a 52% increase year over year, contributing to total revenue of $354 million, which reflects a 22% growth year over year [4][27] - Adjusted EBITDA grew by 35% to $248 million, outpacing top-line growth, showcasing the strength of the royalty-based business model [4][30] - The company raised its full-year 2025 guidance, projecting total revenue of $1.3 billion to $1.375 billion, representing 28% to 35% growth over 2024 [7][31] Business Line Data and Key Metrics Changes - Darzalex Subcutaneous sales increased by 20% to $3.7 billion, with a significant market share gain of approximately 5.7 percentage points across all therapy lines [10][11] - Fesgo generated revenue of approximately $2.3 billion, reflecting a 54% year-over-year increase, with conversion from intravenous therapies reaching 51% [13] - Vyvgart Hytrulo saw total sales increase by 96% year-over-year to $1.13 billion, driven by the subcutaneous formulation enabling self-injection [14][16] Market Data and Key Metrics Changes - The company achieved 13 out of 15 growth catalysts year to date, including new product approvals and expanded indications [5] - The approval of Darzalex Subcutaneous for smoldering multiple myeloma in Europe is expected to expand its market reach significantly [6] - The subcutaneous formulation of Ocrevus is projected to represent an incremental $2 billion opportunity, with analysts estimating total brand sales to reach $10 billion by 2028 [18][19] Company Strategy and Development Direction - The acquisition of Electrovive aims to enhance at-home administration of biologic therapies, expanding the portfolio of drug delivery technologies [8] - The company is focused on patient-centric drug delivery solutions, leveraging its ENHANZE technology alongside new innovations like HyperCon [9] - The strategic goal is to maintain strong momentum in transforming the subcutaneous delivery landscape, with a robust pipeline of future royalty streams [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued strength of the core ENHANZE business and the accelerating momentum across the partner portfolio [34] - The company anticipates sustained royalty contributions from all products through at least 2030, ensuring a robust revenue stream [24] - Management highlighted the importance of ongoing discussions for new ENHANZE agreements, indicating strong interest from potential partners [48] Other Important Information - The company reported a strong balance sheet with cash and marketable securities of $702 million as of September 30, 2025, up from $596.1 million at the end of 2024 [28] - The net debt-to-EBITDA ratio was 0.9 times at the end of the third quarter, indicating a solid financial position [28] Q&A Session Summary Question: Thoughts on capital allocation and debt management - Management indicated a balanced approach to capital allocation, with plans to pay down debt while considering share repurchases and new acquisition opportunities [35][36] Question: Awareness of Electrovive technology among partners - Management noted that there is good awareness of the HyperCon technology among current partners, with strong support for potential collaboration [39] Question: Market growth sources for products - Management highlighted that market growth is coming from both share gains from other therapies and earlier use in treatment [40] Question: Future M&A opportunities - Management stated that while they are actively looking for new opportunities, it is unlikely there will be another acquisition this year following the Electrovive deal [42][43] Question: Updates on pipeline products - Management confirmed that there have not been any public updates from ViiV or Acumen recently, but they are awaiting further information [57]
Is Halozyme Stock a Portfolio Must-Have Ahead of Q3 Earnings?
ZACKS· 2025-10-27 17:45
Core Insights - Halozyme Therapeutics (HALO) is set to report its third-quarter 2025 results on November 3, with sales and earnings estimates at $336.9 million and $1.62 per share respectively [1][7] - Earnings estimates for 2025 have risen from $6.01 to $6.18 per share over the past 60 days [1] Earnings Performance - Halozyme has a strong history of earnings surprises, having exceeded earnings expectations in the last four quarters with an average surprise of 19.74% [2][3] - The most recent quarter saw an earnings surprise of 25.20% [2] Earnings Prediction Model - The company's earnings prediction model indicates a likely earnings beat, supported by a positive Earnings ESP of +2.53% and a Zacks Rank of 3 (Hold) [4][5] Revenue Drivers - The anticipated revenue for Q3 2025 is expected to be bolstered by royalty gains from partnerships with Roche, J&J, and argenx [7][9] - Halozyme's collaboration agreements with large pharmaceutical companies utilizing its ENHANZE technology are key revenue contributors, generating royalties, milestone payments, and annual license fees [8] Recent Developments - Halozyme has entered into an agreement to acquire Elektrofi for $750 million, which is expected to enhance its drug delivery technology and support long-term revenue growth [11][12] - The company reaffirmed its 2025 revenue guidance, expecting total revenues between $1.28 billion and $1.36 billion, with royalty revenues projected at $825-$860 million [13] Stock Performance and Valuation - Year-to-date, Halozyme's shares have increased by 38.4%, outperforming the industry and the S&P 500 [14] - The stock is currently trading at a price-to-sales ratio of 6.97, which is above the industry average of 2.26 but below its five-year mean of 8.41 [16] Financial Position - Halozyme maintains a strong financial position with $548 million in cash and no near-term debt, providing sufficient liquidity for operations [17] Growth Potential - The company is expected to benefit from higher royalties and incremental contributions from proprietary products, alongside the diversification from the Elektrofi acquisition [18] - Analysts have a positive outlook on the stock, reflected in rising earnings estimates [20]
Halozyme Rallies Almost 40% YTD: How Should You Play the Stock?
ZACKS· 2025-10-16 18:56
Core Insights - Halozyme Therapeutics (HALO) is experiencing steady growth in 2025, primarily due to increasing investor confidence in its novel drug delivery technology, ENHANZE, for subcutaneous drug administration [1] Group 1: Business Model and Revenue Streams - Halozyme has collaboration agreements with major pharmaceutical companies utilizing its ENHANZE technology for developing subcutaneous formulations of approved drugs, generating royalties, milestone payments, and annual license fees [2] - The company has eight marketed partnered drugs based on ENHANZE technology, including J&J's Darzalex and Roche's Phesgo [2] - Total revenues in the first half of 2025 reached $373.8 million, driven by a 52.3% year-over-year increase in royalty payments from Roche and J&J [6][7] Group 2: Recent Developments - Halozyme entered a definitive agreement to acquire Elektrofi, enhancing its drug delivery capabilities with Elektrofi's Hypercon technology, expected to support long-term growth through licensing and royalty income [4] - The acquisition deal involves an upfront payment of $750 million and potential milestone payments of $150 million, contingent on regulatory approvals [5] Group 3: Financial Performance and Projections - The company anticipates total revenues for 2025 to be between $1.28 billion and $1.36 billion, reflecting a growth of 26% to 33% compared to 2024 [7] - The Zacks Consensus Estimate for 2025 EPS remains stable at $6.18, with 2026 EPS estimates increasing from $7.57 to $7.61 [15] Group 4: Market Position and Valuation - Year-to-date, Halozyme's stock has increased by 38.8%, outperforming the industry average of 8.2% [10] - The stock is currently trading at a price-to-sales (P/S) ratio of 6.99, which is above the industry average of 2.23 but below its five-year mean of 8.76 [14]
Halozyme Therapeutics (NasdaqGS:HALO) M&A Announcement Transcript
2025-10-01 13:30
Summary of Halozyme Therapeutics Investor Call Company and Industry - **Company**: Halozyme Therapeutics (NasdaqGS: HALO) - **Industry**: Biopharmaceuticals, specifically focusing on biologic drug delivery technologies Core Points and Arguments 1. **Acquisition of Electrify**: Halozyme announced the acquisition of Electrify, a company specializing in Hyperconcentration technology for biologic drugs, aimed at enhancing drug delivery methods [5][6][7] 2. **Hyperconcentration Technology**: This technology allows biologic formulations to achieve concentrations of 400 to 500 mg/mL, significantly higher than current standards, enabling smaller volume injections for at-home administration [6][9] 3. **Market Opportunity**: The acquisition is positioned to capitalize on the growing trend of at-home biologic administration, which is increasingly sought after by pharmaceutical and biotech companies [8][10] 4. **Strategic Fit**: The Hypercon technology complements Halozyme's existing ENHANZE technology, which is known for rapid, high-volume subcutaneous delivery, thus broadening Halozyme's portfolio and enhancing revenue opportunities [9][19] 5. **Financial Terms**: The acquisition involves a $750 million upfront payment, with additional milestone payments tied to the successful marketing approvals of Hypercon products, potentially totaling $275 million [12][13] 6. **Projected Growth**: Two partner products are expected to enter clinical development by 2026, with royalties beginning as early as 2030, indicating a strong revenue growth trajectory [11][30] 7. **Regulatory Confidence**: The acquisition is expected to clear regulatory review without issues, and the technology is designed to create a new formulation with its own registration path [77][90] Additional Important Content 1. **Intellectual Property**: Electrify has a robust patent portfolio with nine issued U.S. patents and additional applications pending, providing long-term protection for the Hypercon technology [27] 2. **Operational Efficiency**: The business model is capital efficient, relying on partnerships for clinical development and commercialization, which minimizes Halozyme's operational costs [20][26] 3. **Market Readiness**: The technology is at a value inflection point, with existing partnerships with major pharma companies validating its potential [21][28] 4. **Future Deal Flow**: Halozyme anticipates an increase in deal flow due to the expanded offerings from both ENHANZE and Hypercon technologies, aiming for more than one deal per year [56][57] 5. **Clinical Derisking**: The acquisition is seen as a derisking opportunity, with significant preclinical data supporting the technology's efficacy and safety [60][63] This summary encapsulates the key points discussed during the Halozyme Therapeutics investor call, highlighting the strategic acquisition of Electrify and its implications for the company's future growth and market positioning.