Risk Sleuth
ARWR · 10-K filed 25 Nov 2025 · year to 30 Sep 2025

Arrowhead Pharmaceuticals

28 named things its latest annual report says its results depend on, each in the company's own words. 18 of them are also named by other companies we've read.

Suppliers

REDEMPLO single-source third-party manufacturer

depends onnamed as a risk
For instance, drug substance and drug product for REDEMPLO are each currently sourced from a single, third-party manufacturer, and many of our pulmonary product candidates are administered using a proprietary delivery device which is currently sourced from a single manufacturer.Risk factors (Item 1A)

Partners and platforms

Amgen Inc.

earns from · up to an additional $485.0 million
The Company remains eligible to receive up to an additional $485.0 million in remaining development, regulatory and sales milestone payments payable from Amgen and Royalty Pharma.Business (Item 1)

Also named by REGN, VKTX

Takeda Pharmaceutical Company Limited

earns from · tiered royalties of 20% to 25% on net sales
Outside the United States, Takeda received an exclusive license to commercialize fazirsiran and will lead the global commercialization strategy, while the Company will be eligible to receive tiered royalties of 20% to 25% on net sales.Business (Item 1)

Also named by NBIX

Vanscoy Rare Pharmacy

depends onnamed as a risk
We have an exclusive agreement with Vanscoy Rare Pharmacy for drug delivery services, and we expect to rely on this pharmacy for a considerable portion of our sales for REDEMPLO.Risk factors (Item 1A)

Sarepta Therapeutics, Inc.

earns fromnamed as a risk
Under our licensing and collaboration agreements with Amgen, Takeda, GSK, Sarepta, Visirna, Sanofi, and Novartis, our partners substantially control clinical development and commercialization for all of the candidates covered under those agreements in their relevant territories.Risk factors (Item 1A)

Visirna

earns fromnamed as a risk
These geopolitical risks could also adversely affect Visirna.Risk factors (Item 1A)

Royalty Pharma

In consideration for the payments under the Royalty Pharma Agreement, Royalty Pharma is entitled to receive all royalties otherwise payable by Amgen to the Company under the Olpasiran Agreement.Business (Item 1)

Also named by BIIB, EXEL, IONS

Sanofi

earns from
(1) Greater China rights for plozasiran are out-licensed to Sanofi.Business (Item 1)

Also named by LGND, MRNA, REGN

GlaxoSmithKline (GSK)

earns from
On December 11, 2023, the Company entered into an Amended and Restated License Agreement with GSK (the “GSK-HBV Agreement”) pursuant to which GSK received a worldwide, exclusive license to develop and commercialize daplusiran/tomligisiran (GSK5637608, formerly JNJ-3989), the Company’s third-generation subcutaneously administered RNAi therapeutic candidate being developed as a potential therapy for patients with chronic hepatitis B virus infection.Business (Item 1)

Also named by MRNA, TEM

Alnylam Pharmaceuticals, Inc.

depends on
Under the assigned Alnylam-Novartis License, the Company acquired a worldwide, royalty-bearing, exclusive license with limited sublicensing rights to existing and future Alnylam intellectual property (including intellectual property that came under Alnylam’s control on or before March 31, 2016), excluding intellectual property concerning delivery technology, to research, develop and commercialize 30 undisclosed gene targets.Business (Item 1)

Also named by REGN

Novartis Pharma AG

earns from
On August 29, 2025, Novartis and the Company entered into a global licensing and collaboration agreement.Business (Item 1)

Other companies

Sixth Street Lending Partners

depends on · $500.0 millionnamed as a risk
The financing agreement establishes a senior secured term loan facility of $500.0 million (the “Credit Facility”), consisting of $400.0 million funded on the closing date and an additional $100.0 million available at our option, subject to mutual agreement with Sixth Street, over a seven-year term.Risk factors (Item 1A)

Competitors

Ionis Pharmaceuticals, Inc.

named as a risk
For example, as the Company previously reported in Form 8-K filed on September 12, 2025, Ionis Pharmaceuticals, Inc. (“Ionis”) filed a complaint for patent infringement against the Company in the United States District Court for the Central District of California alleging patent infringement of United States Patent No. 9,593,333 (“the ’333 patent”) (the "Ionis Claim"), which may impact our planned commercialization of REDEMPLO.Risk factors (Item 1A)

Places

San Diego, California

operates in · more than 251,000 total square feet
The Company operates research laboratory facilities in San Diego, California and Madison, Wisconsin, where its pre-clinical research and development activities, including the discovery and early development of RNAi therapeutics, take place.Business (Item 1)

Also named by BDX, DOC, DXCM, HALO, ILMN, VKTX

Verona, Wisconsin

operates in · approximately 300,000 total square feet
During the first quarter of fiscal 2025, the Company further expanded into a new, state-of-the-art GMP manufacturing facility in Verona, Wisconsin that includes related laboratories and office space to support chemistry, manufacturing, and controls (CMC) and quality activities.Business (Item 1)

China

depends onnamed as a risk
For example, tensions between the United States and China have led to a series of tariffs being imposed by the United States on imports from mainland China, as well as other business restrictions.Risk factors (Item 1A)

Also named by A, AA, AAOI, AAP, AAPL, AB, ADI, AEHR and 261 more

Australia

operates innamed as a risk
Most of our clinical trials involve study subjects outside of the United States, including most of our Phase 1 clinical trials (which often enroll study subjects in Australia and New Zealand), and our Phase 3 clinical trials of plozasiran and zodasiran, for which we have enrolled and plan to enroll cohorts outside the United States.Risk factors (Item 1A)

Also named by AJG, AXP, BF/B, BTU, CL, CSGP, CVX, DECK and 15 more

New Zealand

operates innamed as a risk
Most of our clinical trials involve study subjects outside of the United States, including most of our Phase 1 clinical trials (which often enroll study subjects in Australia and New Zealand), and our Phase 3 clinical trials of plozasiran and zodasiran, for which we have enrolled and plan to enroll cohorts outside the United States.Risk factors (Item 1A)

Also named by AJG, RYN, STZ

Hazards

Russia-Ukraine conflict

named as a risk
For example, a number of our clinical trial sites we had previously planned to use in Russia, Ukraine, and Belarus were shut down and we had to seek alternatives in other geographies.Risk factors (Item 1A)

Also named by ABT, ADM, CAG, CDRE, DOW, EMN, FDX, FLR and 14 more

Commodities and inputs

Synthetic oligonucleotides

depends onnamed as a risk
There are a limited number of manufacturers that supply synthetic oligonucleotides.Risk factors (Item 1A)

Regulators

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk
Our business depends upon the ability of the FDA to accept and review our potential regulatory filings.Risk factors (Item 1A)

Also named by A, ABBV, ABT, AMGN, ARE, ATR, AXGN, BAX and 112 more

Laws and programs

U.S. pharmaceutical import tariffs

exposed to its price · up to 100% tariffsnamed as a risk
Furthermore, in September 2025, the current Presidential Administration announced plans to impose up to 100% tariffs on imported branded or patented pharmaceutical products, subject to certain exceptions.Risk factors (Item 1A)

Medicare

earns fromnamed as a risk
Sales of REDEMPLO, or any other approved drug candidate, will depend in part on the availability of coverage and reimbursement from third-party payers such as government insurance programs, including Medicare and Medicaid, private health insurers, health maintenance organizations and other health care related organizations, who are increasingly challenging the price of medical products and services.Risk factors (Item 1A)

Also named by ABT, AXGN, BAX, BDX, BMY, BSX, CAH, CDNA and 48 more

One Big Beautiful Bill Act

subject tonamed as a risk
And the recently-enacted One Big Beautiful Bill Act (the “OBBBA”) imposes new restrictions on funding for government health care programs and on individual eligibility for coverage under those programs, which may lead to lower reimbursements for drugs covered by those programs.Risk factors (Item 1A)

Also named by AA, ABR, ADI, ADM, ALB, AMAT, AMGN, AMKR and 121 more

Medicaid

earns fromnamed as a risk
Sales of REDEMPLO, or any other approved drug candidate, will depend in part on the availability of coverage and reimbursement from third-party payers such as government insurance programs, including Medicare and Medicaid, private health insurers, health maintenance organizations and other health care related organizations, who are increasingly challenging the price of medical products and services.Risk factors (Item 1A)

Also named by ABBV, ABT, ARE, BAX, BMY, BSX, CHE, CNC and 39 more

Inflation Reduction Act (IRA)

subject tonamed as a risk
For example, the IRA includes several measures intended to lower the cost of prescription drugs and related healthcare reforms, including limits on price increases and subjecting an escalating number of drugs to annual price negotiations with the Centers for Medicare & Medicaid Services ("CMS").Risk factors (Item 1A)

Also named by AEE, AMGN, BIIB, BKNG, BMY, CAH, CI, CNC and 26 more

Orphan Drug Act

subject tonamed as a risk
It is possible that another RNAi drug could be approved for the treatment of a disease that one of our orphan products is intended to treat before our product is approved, which means that we may not obtain orphan drug exclusivity and could also potentially be blocked from approval until the first product’s orphan drug exclusivity period expires or we demonstrate, if we can, that our product is superior.Risk factors (Item 1A)

Also named by IONS, KRYS, NBIX, PVLA, UTHR, VKTX

Most Favored Nation drug pricing executive order

subject tonamed as a risk
In addition, an executive order issued by the White House on May 12, 2025, directs the Department of Health and Human Services (the “HHS”) to implement a “Most Favored Nation” drug pricing policy.Risk factors (Item 1A)

Also named by HALO, INCY, MRNA, REGN