HALOZYME THERAPEUTICS, INC.

Halozyme Therapeutics, Inc. operates in the biopharmaceutical industry, focusing on drug delivery technologies that improve patient experiences and outcomes for emerging and established therapies. The company's commercially validated ENHANZE drug delivery technology, utilizing its proprietary enzyme rHuPH20, facilitates the subcutaneous delivery of injected drugs and fluids. Halozyme also develops partner products with Hypercon drug delivery technology and the Surf Bio drug delivery technology to expand its drug delivery technology portfolio. The company develops, manufactures, and commercializes drug-device combination products using advanced auto-injector technologies designed to provide commercial or functional advantages such as improved convenience, reliability, tolerability, and enhanced patient comfort and adherence.

The company faces competition from a number of sources, including large pharmaceutical companies, smaller pharmaceutical companies, biotechnology companies, academic institutions, government agencies, and private and public research institutions, many of which have greater financial resources, drug development experience, sales and marketing capabilities, manufacturing capabilities, experience in obtaining regulatory approvals, and other resources. For the ENHANZE technology, competitors may include major pharmaceutical and specialized biotechnology firms, and Alteogen Inc. has developed ALT-B4, a modified human hyaluronidase that has been licensed for use in SC formulations. For Hylenex recombinant, the competitor includes Amphastar Pharmaceuticals, Inc.'s product, Amphadase, a bovine hyaluronidase. For XYOSTED, competitors include various formulations for testosterone replacement therapy such as transdermal solutions, injectables, surgically implanted pellets, intranasal products, and oral formulations from companies including AbbVie, Perrigo, Lilly, Endo, Pfizer, Tolmar Pharmaceuticals, Verity Pharmaceuticals, and Marius Pharmaceuticals. For devices, competitors include established specialty pharmaceutical companies, major brand name and generic manufacturers such as Teva, Viatris, Lilly, and Endo, as well as medical device companies including Scandinavian Health Ltd., Ypsomed AG, West Pharmaceutical, and Owen Mumford Ltd.

Halozyme generates revenue through three primary streams: royalties from licensing its ENHANZE technology and other royalty arrangements, revenues under collaborative agreements, and sales of proprietary and partnered products. The company licenses its ENHANZE technology to biopharmaceutical companies to collaboratively develop products that combine ENHANZE with partners' proprietary compounds. In addition to receiving upfront licensing fees from ENHANZE collaborations, Halozyme is entitled to receive event and sales-based milestone payments, revenues from the sale of bulk rHuPH20, and royalties from commercial sales of approved partner products co-formulated with ENHANZE. The company also earns royalties from the sales of ten commercial products, including five from the Roche collaboration, two from the Janssen collaboration, and one from each of the Takeda, argenx, and BMS collaborations. Through the acquisition of Elektrofi, Halozyme has Hypercon collaboration and license agreements with Janssen, Lilly, and argenx, entitling it to upfront license fees, event and sales-based milestone payments, and royalties from commercial sales for approved partner products co-formulated with Hypercon. The commercial portfolio of proprietary products includes Hylenex, utilizing rHuPH20, and XYOSTED, utilizing auto-injector technology.

Halozyme's ENHANZE collaborations and licensing agreements are with F. Hoffmann-La Roche, Ltd. and Hoffmann-La Roche, Inc., Takeda Pharmaceuticals International AG and Baxalta US Inc., Pfizer Inc., Janssen Biotech, Inc., AbbVie, Inc., Eli Lilly and Company, Bristol-Myers Squibb Company, argenx BVBA, ViiV Healthcare, Chugai Pharmaceutical Co., Ltd., Acumen Pharmaceuticals, Inc., Merus N.V., and Skye Bioscience, Inc. The company currently earns royalties from the sales of ten commercial products including sales of five commercial products from the Roche collaboration, two commercial products from the Janssen collaboration and one commercial product from each of the Takeda, argenx and BMS collaborations. Through the acquisition of Elektrofi, Halozyme has Hypercon collaboration and license agreements with Janssen, Lilly, and argenx. The company has commercialized auto-injector products with Teva Pharmaceutical Industries, Ltd. and has development programs including auto-injectors with McDermott Laboratories Limited, an affiliate of Viatris Inc. The commercial portfolio of proprietary products includes Hylenex, utilizing rHuPH20, and XYOSTED, utilizing auto-injector technology. In December 2025, Halozyme made a strategic decision to discontinue the development of ATRS-1902.

In November 2025, Halozyme completed the acquisition of Elektrofi, Inc., subsequently renamed Halozyme Hypercon, Inc., for total purchase consideration of $810.4 million ¹, resulting in an expansion of the drug delivery technology portfolio. In December 2025, Halozyme completed the acquisition of Surf Bio, Inc., subsequently renamed Halozyme Surf Bio, Inc., for total purchase consideration of $305.0 million ² to selling shareholders, inclusive of $10.2 million ³ in transaction expenses. In November 2025, Halozyme completed the sale of $750.0 million ⁴ aggregate principal amount of 0.875% Convertible Senior Notes due 2032 and $750.0 million ⁵ aggregate principal amount of 0.00% Convertible Senior Notes due 2031. In November 2025, Halozyme entered into an amendment to its credit agreement that extended the maturity date and increased the borrowing capacity of its existing revolving credit facility from $575.0 million ⁶ to $750.0 million ⁷. In June 2025, Halozyme initiated the third $250 million ⁸ share repurchase tranche under the $750 million ⁹ approved program from February 2024, and as of December 31, 2025, $92.3 million ¹⁰ had been used to repurchase approximately 1.7 million ¹¹ shares at an average price of $52.89 ¹² per share. In May 2025, Halozyme announced a second $250 million ¹³ share repurchase under the $750 million ¹⁴ approved program, which was completed in June 2025, resulting in a total purchase of 4.8 million ¹⁵ shares at an average price of $52.09 ¹⁶ per share. In April 2025, Halozyme filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. in the U.S. District Court in New Jersey alleging that Merck is using Halozyme's patented MDASE subcutaneous drug delivery technology to develop Subcutaneous Keytruda. In December 2025, Halozyme and Takeda entered into a new global collaboration and exclusive license agreement which provides Takeda with access to ENHANZE for use with vedolizumab. In December 2025, Halozyme entered into a commercial license and supply agreement with Viatris under which Halozyme licenses and supplies an auto-injector product for self-administered SC selatogrel. In November 2025, Halozyme and Merus entered into a non-exclusive global collaboration and license agreement that provides Merus access to ENHANZE for a single target. In December 2025, Halozyme and Skye Bioscience entered into a non-exclusive global collaboration and license agreement that provides Skye Bioscience access to ENHANZE for the development and potential commercialization of SC formulation of nimacimab.

Total revenues for the year ended December 31, 2025 were $1,396,611,000 ¹⁷, compared to $1,015,324,000 ¹⁸ for the year ended December 31, 2024. Net income for the year ended December 31, 2025 was $316,889,000 ¹⁹, compared to $444,091,000 ²⁰ for the year ended December 31, 2024. Diluted earnings per share for the year ended December 31, 2025 was $2.56 ²¹, compared to $3.43 ²² for the year ended December 31, 2024. Operating income for the year ended December 31, 2025 was $469,006,000 ²³, compared to $551,475,000 ²⁴ for the year ended December 31, 2024. Net cash provided by operating activities for the year ended December 31, 2025 was $651,558,000 ²⁵, compared to $479,064,000 ²⁶ for the year ended December 31, 2024.

A key growth vector is the continued expansion of ENHANZE collaborations. Halozyme currently has thirteen ENHANZE collaborations and licensing agreements, and the company intends to work with existing partners to expand collaborations to add new targets and develop targets and product candidates under the terms of the operative collaboration agreements. The company will also continue its efforts to enter into new collaborations to derive additional revenue from its proprietary technology. The company expects royalty revenue to grow further as a result of anticipated increasing partner product sales of DARZALEX SC, Phesgo and VYVGART Hytrulo, the largest drivers of royalty revenues. The total of all other products is also expected to grow, mainly driven by recently launched ENHANZE partner products, TECENTRIQ SC and OCREVUS SC by Roche, RYBREVANT SC by Janssen and Opdivo Qvantig by BMS, partially offset by modest price erosion expected to continue on earlier launched ENHANZE partner products, Herceptin and MabThera.

Another growth vector is the expansion of the drug delivery technology portfolio through the recently acquired Hypercon and Surf Bio technologies. With the acquisitions of Elektrofi and Surf Bio, the company's goal is to extend the number of partners and products being developed and commercialized by offering the Hypercon and Surf Bio technologies to further expand the drug delivery portfolio. The Hypercon technology is an innovative microparticle approach enabling hyperconcentration of monoclonal antibodies, certain complex proteins and peptides while maintaining syringeability, enabling biologic product formulation concentrations of ~500 mg/ml, which can be up to four to five times higher than standard aqueous solution formulations for biologics today. The Surf Bio technology is an innovative, polymer-enabled approach enabling hyperconcentration SC of monoclonal antibodies, other biologics and small molecules while maintaining syringeability, enabling concentrations of up to 500 mg/mL. The company also intends to extend the range of auto-injectors available to current and new partners, and it is the company's goal to further extend the number of partners for the current auto-injectors and add new partners for the high-volume auto-injector that utilizes ENHANZE technology.

The filing does not contain explicit margin trajectory or cost structure evolution targets.

The filing does not contain explicit supply chain posture, manufacturing capacity, technology infrastructure investments, or headcount strategy targets beyond the general description of operations.

Research and development expenses for the year ended December 31, 2025 were $81,490,000 ²⁷. Purchases of property and equipment for the year ended December 31, 2025 were $6,970,000 ²⁸. In February 2024, the Board of Directors authorized a capital return program to repurchase up to $750.0 million ²⁹ of outstanding common stock. As of December 31, 2025, $92.3 million ³⁰ had been used to repurchase approximately 1.7 million ³¹ shares at an average price of $52.89 ³² per share under the third tranche of this program. The company has never declared or paid any dividends on its common stock and currently intends to retain available cash for funding operations, stock repurchases and other capital initiatives, and does not expect to pay any dividends in the foreseeable future.

A structural headwind is the potential for modest price erosion on earlier launched ENHANZE partner products such as Herceptin and MabThera, which are later in their life cycle. The company also faces risks related to the expiration of patents, including an issued U.S. patent which expires in 2027 and additional patents that are valid into 2029, which the company believes cover the products and product candidates under its ENHANZE collaborations and Hylenex recombinant. Upon expiration of these patents, other pharmaceutical companies may seek to compete by developing, manufacturing and selling biosimilars to the active drug ingredient in the ENHANZE technology. Additionally, the company faces risks from changes in U.S. trade policy, including tariffs and potential countermeasures by trading partners, which could delay regulatory approval and increase costs, disrupt global supply chains and have a material adverse impact on the business.

A key constraint is the company's reliance on a limited number of third-party manufacturers for bulk rHuPH20, including Avid Bioservices, Inc. and Catalent Indiana LLC, and the company expects Lonza Sales AG to eventually produce bulk rHuPH20. Any disruption in the supply of bulk rHuPH20 or other components by these manufacturers or vendors could delay or suspend development or commercialization efforts. The company also faces risks related to the concentration of revenues and accounts receivable among a few partners, with approximately 69% ³³ of the accounts receivable balance as of December 31, 2025 representing amounts due from Janssen, Roche and argenx, and approximately 60% ³⁴ of the accounts receivable balance as of December 31, 2024 representing amounts due from Janssen and Roche.

The company is heavily dependent on its ENHANZE collaborations, and any adverse development regarding the rHuPH20 enzyme could substantially impact multiple areas of the business, including current and potential ENHANZE collaborations and revenues, as well as any proprietary programs. The company relies on a limited number of third-party manufacturers for bulk rHuPH20, including Avid Bioservices, Inc. and Catalent Indiana LLC, and any disruption in supply could delay or suspend development or commercialization efforts. The company faces significant customer concentration risk, with approximately 69% ³⁵ of the accounts receivable balance as of December 31, 2025 representing amounts due from Janssen, Roche and argenx. The company has substantial debt, with aggregate consolidated indebtedness, net of debt discount, of $2,142.6 million ³⁶ as of December 31, 2025, and failure to fulfill obligations under debt agreements could cause repayment obligations to accelerate. The company's ability to license its ENHANZE and device technologies depends on the validity of its patents, and an issued U.S. patent expires in 2027, with additional patents valid into 2029, which could lead to loss of patent protection and reduced revenues.

Management's message emphasizes the company's position as a leader in converting IV biologics to SC delivery and extending the dosing interval of SC drugs using the commercially-validated ENHANZE technology. The strategic priorities for the period ahead include working with existing partners to expand collaborations to add new targets and develop product candidates, continuing efforts to enter into new collaborations to derive additional revenue from proprietary technology, and extending the number of partners and products being developed and commercialized by offering the Hypercon and Surf Bio technologies to further expand the drug delivery portfolio. Management also intends to extend the range of auto-injectors available to current and new partners and add new partners for the high-volume auto-injector that utilizes ENHANZE technology.