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Halozyme Therapeutics, Inc. is a biotechnology company focused on developing and commercializing drug/device combination products. The company generates revenue through royalties, product sales, and collaborative agreements. Its operations include compliance with regulatory requirements and healthcare laws, as well as investments in research and development.
- Royalties - Earns revenue from royalties on products developed using its proprietary technology, contributing significantly to overall revenue.
- Product Sales - Sells proprietary products, bulk rHuPH20, and device-partnered products.
- Collaboration Revenue - Generates income from collaborative agreements, including upfront license fees, milestone fees, and device licensing and development revenue.
| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Mark Snyder Executive | Senior Vice President, General Counsel, Chief Compliance Officer, and Secretary | Mark Snyder is currently the Senior Vice President, General Counsel, Chief Compliance Officer, and Secretary at Halozyme Therapeutics, having joined the company in January 2022. He brings over 30 years of experience and previously held senior legal roles at Qualcomm from 2008 to 2021. | ||
Nicole LaBrosse Executive | Senior Vice President, Chief Financial Officer | Nicole LaBrosse is the Senior Vice President and Chief Financial Officer at Halozyme Therapeutics, Inc., serving in this executive capacity since at least February 20, 2024. There is no information regarding board memberships or other roles at the company. | ||
Bernadette Connaughton Board | Director, Chair of the Compensation Committee | Director at Editas Medicine, Inc. ; Director at Zealand Pharma A/S | Bernadette Connaughton has been serving as a Director and Chair of the Compensation Committee at Halozyme since 2018. She brings extensive expertise in pharma business leadership, international operations, and human capital management from her prior senior roles at Bristol-Myers Squibb. | |
Jeffrey W. Henderson Board | Chair of the Board of Directors | Member of Board of Directors of Becton Dickinson ; Member of Board of Directors of Qualcomm, Inc. ; President of JWH Consulting LLC | Jeffrey W. Henderson has been serving as the non-employee Chair of the Board of Directors at HALO since May 2022 and as a Director since 2015. He brings over 30 years of financial, commercial, and pharmaceutical expertise. | |
Mahesh Krishnan Board | Board Member | Group Vice President of Growth at DaVita, Inc. | Mahesh Krishnan, M.D. has served on the Board of Directors of Halozyme Therapeutics, Inc. since April 25, 2024 , and previously held leadership roles including Group Vice President of Growth at DaVita, Inc.. | |
Moni Miyashita Board | Board Director | Managing Partner at Beacon Hill Strategy Group | Moni Miyashita has been serving as a Director at HALO since March 11, 2022. With over 25 years of global experience in business transformations, strategy and M&A, she previously held roles including Chief Strategy Officer at Valo Health, LLC and Partner at Innosight Consulting. |
- Given the sequential impact of the annual contractual rate resets, can you explain in detail how you expect the shift from the Q1 negative 10% royalty rate to a full rate to occur within the year, particularly with DARZALEX’s rapid volume growth?
- With the current exclusivity agreement preventing partnering on PD-1 bispecific programs, what steps is management taking to ensure this limitation does not hinder future business development opportunities?
- For the small volume auto-injector deal, can you provide more specifics on its anticipated commercial impact and how it compares to the potential of the high-volume auto-injector, despite the current confidentiality constraints?
- You defined mid-single digit royalty rates as 3% to 7%—what potential risks or market dynamics could push these rates outside of that range, especially given the variability seen with products like DARZALEX subcutaneous?
- With guidance projecting royalty revenue exceeding $1 billion by 2027 and durability extending into the 2040s, what are the key regulatory or market risks that could derail these projections, particularly with emerging products such as amivantamab subcutaneous?
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
The company produces Amphadase®, a bovine (bull) hyaluronidase, which is a competitor to Hylenex recombinant, the only FDA-approved recombinant human hyaluronidase on the market. | |
The company offers Androgel®, a transdermal solution for testosterone replacement therapy, which competes with XYOSTED in the U.S. testosterone replacement market. | |
The company provides a generic version of Androgel® Topical Gel 1.62%, competing in the U.S. testosterone replacement market. | |
The company markets Axiron®, a transdermal solution for testosterone replacement therapy, and is also a competitor in the medical device space. | |
The company offers Testim®, Fortesta®, Aveed®, and Testopel® pellets for testosterone replacement therapy, competing with XYOSTED. | |
Verity Pharma | The company markets TLANDO® and Natesto®, which are testosterone replacement therapies competing with XYOSTED. |
The company provides Depo®-Testosterone, an injectable form of testosterone replacement therapy, competing with XYOSTED. | |
Actavis | The company sells generic oil testosterone products, competing in the testosterone replacement therapy market. |
Sandoz | The company offers generic oil testosterone products, competing in the testosterone replacement therapy market. |
The company markets generic oil testosterone products, competing in the testosterone replacement therapy market. | |
The company provides generic oil testosterone products and is a competitor in the medical device space. | |
Tolmar | The company offers JATENZO®, an oral formulation for testosterone replacement therapy, competing with XYOSTED. |
Marius Pharmaceuticals | The company markets Kyzatrex, an oral formulation for testosterone replacement therapy, competing with XYOSTED. |
Scandinavian Health Ltd. | The company is a competitor in the medical device space, focusing on specific market segments. |
Ypsomed AG | The company is a competitor in the medical device space, focusing on specific market segments. |
The company is a competitor in the medical device space, focusing on specific market segments. | |
Owen Mumford Ltd. | The company is a competitor in the medical device space, focusing on specific market segments. |
| Customer | Relationship | Segment | Details |
|---|---|---|---|
Janssen | Collaboration with licensing and development agreements. | All | Accounts receivable: part of 60% (2024) ; total revenue: 41% (2024), 44% (2023), 46% (2022). |
Roche | Collaboration with licensing and development agreements. | All | Accounts receivable: part of 60% (2024) ; total revenue: 17% (2024), 19% (2023), 20% (2022). |
Teva | Supply and development agreements for pharmaceuticals. | All | Accounts receivable: part of 69% (2023) ; total revenue: 8% (2024), 10% (2023). |
Notable M&A activity and strategic investments in the past 3 years.
| Company | Year | Details |
|---|---|---|
Antares Pharma, Inc. | 2022 |
Recent press releases and 8-K filings for HALO.
- Halozyme Therapeutics announced that argenx received a positive CHMP opinion recommending European Commission approval for VYVGART® 1000mg (efgartigimod alfa), co-formulated with its proprietary ENHANZE® technology for treating adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
- The positive recommendation, based on outcomes from the ADHERE clinical trial—the largest study of its kind in CIDP patients—brings the treatment closer to market launch across the European Union and associated regions.
- Halozyme Therapeutics Inc has filed a patent infringement lawsuit in New Jersey against Merck Sharp & Dohme Corp, alleging that Merck’s subcutaneous formulation of Keytruda infringes on its MDASE technology and seeks damages and injunctive relief.
- The lawsuit highlights that Merck intended to launch SC Keytruda in 2025 without obtaining a license for Halozyme’s patented technology, and the dispute does not affect Halozyme’s ENHANZE licensing program.
- Halozyme Therapeutics announced FDA approval of argenx’s VYVGART® Hytrulo prefilled syringe, co-formulated with its ENHANZE® technology, for self-injection in adult patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP).
- The 20-to-30-second subcutaneous injection is designed for self-administration by patients, caregivers, or healthcare professionals, following proper training, supporting improved treatment convenience.
- European Commission approves the subcutaneous DARZALEX regimen combined with VRd for treatment of newly diagnosed multiple myeloma patients regardless of transplant eligibility.
- The regimen utilizes Halozyme’s ENHANZE technology to enable rapid subcutaneous delivery, reducing the need for lengthy IV infusions.
- This approval follows a previous extension for transplant-eligible patients received in October 2024.
- Halozyme Therapeutics announced that Janssen-Cilag, a Johnson & Johnson company, received European Commission marketing authorization for the subcutaneous formulation of RYBREVANT® (amivantamab) co-formulated with ENHANZE® technology.
- The approval supports its use in first-line treatment for advanced NSCLC with specific EGFR mutations and as a monotherapy for patients with advanced NSCLC after platinum-based therapy failure, based on positive Phase 3 PALOMA-3 study data.
- This marks the tenth approved partner product utilizing Halozyme’s ENHANZE® drug delivery technology.
- Bristol Myers Squibb received a positive CHMP opinion recommending approval of the subcutaneous formulation of Opdivo® developed with Halozyme’s ENHANZE® technology, targeting multiple solid tumor indications.
- The formulation’s approval will now be reviewed by the European Commission, with a decision expected by June 2, 2025.
- The CHMP opinion is supported by positive Phase 3 CheckMate-67T trial results, reinforcing the potential benefits of a faster and more flexible treatment option.
- Halozyme achieved record full year 2024 revenue of $1.015B with 22% YOY growth, driven by robust royalty revenue performance .
- In Q4 2024, the company delivered $298M in revenue, marking a 30% increase over Q4 2023 .
- Royalty revenue surged 27% to $571M, significantly boosting overall results .
- Net income reached $444M and experienced a 58% YOY increase, underscoring improved operational efficiency .
- The 2025 financial guidance projects total revenue of $1.15B–$1.225B, adjusted EBITDA of $755M–$805M, non-GAAP EPS of $4.95–$5.35, with additional guidance for royalty revenue of $725M–$750M .
- Maintaining a strong financial profile, Halozyme reported low net leverage at 1.3x, executed a $250M share repurchase program, and generated significant free cash flow .
- Janssen-Cilag International NV received a positive CHMP opinion for extending the marketing authorization of the subcutaneous RYBREVANT® (amivantamab) formulation co-formulated with ENHANZE®, aimed at treating advanced EGFR-mutated NSCLC in specific patient populations.
- The decision, supported by positive results from the Phase 3 PALOMA-3 study, highlights benefits such as a five-minute administration time and a five-fold reduction in infusion-related reactions.
- Halozyme raised its 2025 financial guidance with projected total revenue of $1.15–$1.225B, adjusted EBITDA of $755–$805M, and non-GAAP diluted EPS of $4.95–$5.35 .
- The update reflects YoY growth improvements of 16–23% in revenue, 21–30% in non-GAAP EPS, and 24–32% in adjusted EBITDA .
- The company reiterated its full-year 2024 estimates .
- A new $250M Accelerated Share Repurchase program was announced, contributing to a cumulative $1.55B in buybacks—including an existing $750M plan .
- Multi-year outlook (2024–2028) projects substantial growth in total revenue, royalty revenue, and adjusted EBITDA, driven by key products like VYVGART Hytrulo and DARZALEX subcutaneous, plus a portfolio of 9 approved products and amivantamab .