Halozyme Therapeutics
38 named things its latest annual report says its results depend on, each in the company's own words. 11 of them are also named by other companies we've read.
Customers
F. Hoffmann-La Roche Ltd. (Roche)
earns from · five commercial productsWe currently earn 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.Business (Item 1)
Janssen Biotech, Inc.
earns from · two commercial productsWe currently earn 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.Business (Item 1)
Takeda Pharmaceuticals International AG
earns fromnamed as a riskFor example, Roche is responsible for producing the Herceptin and MabThera required for its SC products and Takeda is responsible for producing the GAMMAGARD LIQUID for its product HYQVIA.Risk factors (Item 1A)
McKesson Corporation
earns fromWe also contract with numerous wholesale distributors, including Cardinal Health 105, Inc., also known as Specialty Pharmaceutical Services (“Cardinal”), McKesson Corporation and Cencora Inc. (formerly known as AmerisourceBergen Corporation) to distribute XYOSTED, to retail pharmacies as well as the Veterans Administration and other governmental agencies.Business (Item 1)
Also named by ABBV, AMGN, CAH, COR, GILD, HROW, HSIC, LLY and 1 more
argenx BVBA
earns fromIn June 2023, argenx received FDA approval under the brand name VYVGART® Hytrulo for the SC injection with ENHANZE for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.Business (Item 1)
Bristol-Myers Squibb Company (BMS)
earns fromIn December 2024, BMS announced the FDA approved Opdivo® Qvantig (nivolumab and hyaluronidase-nvhy) with ENHANZE for SC use in most previously approved adult, solid IV Opdivo (nivolumab) indications.Business (Item 1)
Teva Pharmaceutical Industries, Ltd.
earns fromWe are the exclusive supplier of the device, which we developed, for Teva’s generic Epinephrine Injection USP products, indicated for emergency treatment of severe allergic reactions including those that are life threatening (anaphylaxis) in adults and certain pediatric patients.Business (Item 1)
Viatris Inc.
earns fromIn December 2025, we entered into a commercial license and supply agreement with Viatris under which we license and supply an auto-injector product for self-administered SC selatogrel for the treatment of acute myocardial infarction in adult patients.Business (Item 1)
Suppliers
Catalent Indiana LLC
depends onnamed as a riskCatalent currently produces bulk rHuPH20 for use in Hylenex and collaboration products and product candidates.Business (Item 1)
Also named by REGN
Avid Bioservices, Inc.
depends onnamed as a riskFor example, we have existing supply agreements with contract manufacturing organizations Avid Bioservices, Inc. (“Avid”) and Catalent Indiana LLC (“Catalent”) to produce bulk rHuPH20.Risk factors (Item 1A)
Lonza Sales AG
depends onAvid and Catalent currently produce and we anticipate Lonza will eventually produce bulk rHuPH20 under current Good Manufacturing Practices for clinical and commercial uses.Business (Item 1)
Patheon Manufacturing Services, LLC
depends onWe have a commercial manufacturing and supply agreement with Patheon Manufacturing Services, LLC (“Patheon”) under which Patheon will provide the final fill and finishing steps in the production process of Hylenex recombinant.Business (Item 1)
Phillips-Medisize Corporation
depends onPhillips-Medisize Corporation, an international outsource provider of design and manufacturing services, produces commercial quantities of components of our QuickShot auto-injector device for XYOSTED and other partnered products and our VIBEX epinephrine auto-injector product with Teva.Business (Item 1)
ComDel Innovation, Inc.
depends onComDel Innovation, Inc., a domestic provider of integrated solutions for product development, tooling, and manufacturing, produces commercial quantities of components for the VIBEX epinephrine and teriparatide auto-injector products with Teva.Business (Item 1)
Fresenius Kabi
depends onFresenius Kabi and Pharmaceutics International Inc. supply commercial quantities of pre-filled syringes of testosterone for XYOSTED.Business (Item 1)
Pharmaceutics International Inc.
depends onFresenius Kabi and Pharmaceutics International Inc. supply commercial quantities of pre-filled syringes of testosterone for XYOSTED.Business (Item 1)
Sharp Corporation
depends onSharp Corporation, an international contract packaging company, assembles and packages XYOSTED auto-injector products.Business (Item 1)
Nolato Contour, Inc.
depends onNolato Contour, Inc. produces commercial quantities of components of our QuickShot auto-injector device for XYOSTED.Business (Item 1)
Partners and platforms
AmerisourceBergen (Integrated Commercialization Solutions)
depends onWe engage Integrated Commercialization Solutions, a division of AmerisourceBergen Specialty Group, a subsidiary of AmerisourceBergen, to act as our exclusive distributor for commercial shipment and distribution of Hylenex recombinant to our customers in the U.S.Business (Item 1)
Cardinal Health
depends onCardinal provides us with services related to logistics, warehousing, returns and inventory management, sales reports, contract administration, chargebacks processing and accounts receivable management.Business (Item 1)
Knipper Health, Inc.
depends onKnipper provides us with the same services except chargeback processing.Business (Item 1)
Other companies
Merck Sharp & Dohme Corp.
named as a riskFor example, in April 2025 we filed a patent infringement lawsuit against Merck Sharp & Dohme Corp. (“Merck”) 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 (“SC”) Keytruda.Risk factors (Item 1A)
Competitors
Alteogen Inc.
competes withnamed as a riskFor example, Alteogen Inc. has developed ALT‑B4, a modified human hyaluronidase that has been licensed for use in SC formulations.Business (Item 1)
Amphastar Pharmaceuticals, Inc.
competes withnamed as a riskThe competitors for Hylenex recombinant include, but are not limited to, Amphastar Pharmaceuticals, Inc.’s product, Amphadase®, a bovine (bull) hyaluronidase.Risk factors (Item 1A)
Places
San Diego, California
operates innamed as a riskOur operations, including laboratories, offices and other research facilities, are headquartered in San Diego, California.Risk factors (Item 1A)
Minnetonka, Minnesota
operates innamed as a riskIn addition, our Minnetonka, Minnesota facility supports our administrative functions, product development and quality operations and provides additional assembly and warehousing capabilities, and therefore is subject to relevant risks comparable to those of our third-party manufacturers.Risk factors (Item 1A)
Commodities and inputs
Swiss franc
exposed to its pricenamed as a riskWe hedge a portion of foreign currency exchange risk associated with forecasted royalties revenue denominated in Swiss francs to reduce the risk of our earnings and cash flows being adversely affected by fluctuations in exchange rates.Market risk (Item 7A)
rHuPH20
depends onnamed as a riskrHuPH20 is a key technological component of Hylenex and our ENHANZE technology and most of our ENHANZE partnered products and product candidates, including the current and future products and product candidates under our ENHANZE collaborations.Risk factors (Item 1A)
Regulators
U.S. Food and Drug Administration (FDA)
subject tonamed as a riskAdditionally, recent widespread reductions in workforce at federal health agencies, including the FDA, could have a negative impact on the speed with which our products or devices and our partners’ products are reviewed and approved for commercialization.Risk factors (Item 1A)
Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more
Centers for Medicare & Medicaid Services (CMS)
subject tonamed as a riskCMS, the federal agency responsible for administering Medicare and overseeing state Medicaid programs and Health Insurance Marketplaces, has substantial power to implement policy changes or demonstration projects that can quickly and significantly affect how drugs, including our partners’ products, are covered and reimbursed.Risk factors (Item 1A)
Also named by A, ABT, AMGN, AXGN, BAX, BWIN, CNC, COO and 23 more
U.S. Drug Enforcement Administration (DEA)
subject tonamed as a riskCertain of our products are controlled substances and accordingly, we, and our contractors, distributors, prescribers, and dispensers must comply with Federal controlled substances laws and regulations, enforced by the DEA, as well as state-controlled substances laws and regulations enforced by state authorities.Risk factors (Item 1A)
Also named by CAH, COR, DGX, DHR, HSIC, IQV, LH, MCK and 7 more
European Patent Office
subject tonamed as a riskFor example, as a result of two such proceedings, in March 2023 and October 2024 the Opposition Division of the European Patent Office revoked two of Janssen’s co-formulation patents for DARZALEX® (daratumumab) SC.Risk factors (Item 1A)
Laws and programs
2022 Credit Agreement
maximum consolidated net leverage ratio of 4.50 to 1.00named as a riskThe 2022 Credit Agreement also includes financial covenants requiring us to maintain, measured as of the end of each fiscal quarter, a maximum consolidated net leverage ratio of 4.50 to 1.00 initially and a minimum consolidated interest coverage ratio of 3.00 to 1.00.Risk factors (Item 1A)
Also named by ALB
U.S. tariffs
exposed to its pricenamed as a riskSuch tariffs and any countermeasures by the U.S.’ trading partners could increase the cost of raw materials, components and finished goods necessary for our or our partners’ operations, disrupt global supply chains, create additional operational challenges and cause widespread uncertainty in the financial markets.Risk factors (Item 1A)
Also named by A, AAPL, ACHR, ADI, AEHR, AEP, AIOT, AKAM and 170 more
Inflation Reduction Act of 2022
subject tonamed as a riskIn May 2025, CMS issued draft guidance for 2028 price controls under the IRA that creates uncertainty as to whether combination therapies, such as our partners’ ENHANZE products, will be protected from IRA price negotiations for thirteen years following approval of the combination therapy.Risk factors (Item 1A)
Also named by ABBV, APD, ARE, BKH, DD, DHR, ELV, ENPH and 30 more
Most Favored Nation drug pricing Executive Order
subject tonamed as a riskThe Executive Order directs the Secretary of the Department of Health and Human Services (“HHS”) to communicate Most Favored Nations (“MFN”) price targets to pharmaceutical manufacturers to bring prices in line with comparably developed nations.Risk factors (Item 1A)
Technology
ENHANZE
concentrated in · a substantial portion of our revenuesnamed as a riskWe derive a substantial portion of our revenues from our ENHANZE collaborations.Risk factors (Item 1A)
rHuPH20 patents
an issued U.S. patent which expires in 2027named as a riskAny such loss of patent protection or proprietary rights could lead to a reduction or loss of revenues, incentivize one or more of our key ENHANZE partners to terminate their relationship with us and impact our ability to enter into new collaboration and license agreements.Risk factors (Item 1A)