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Arrowhead Pharmaceuticals, Inc. (ARWR): Business Model Canvas [Dec-2025 Updated] |
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You're looking at Arrowhead Pharmaceuticals, Inc. (ARWR) right now, trying to map out how a pure R&D shop suddenly flips the switch to commercial reality. Honestly, the 2025 numbers tell the defintely pivotal story: the platform validation from REDEMPLO's FDA nod, combined with a staggering $829.4 million in collaboration and license revenue for FY2025, shows the licensing engine is doing heavy lifting while they build the sales force. With $919 million in the bank as of September 2025, they have the runway, but the real test is translating those deep pipeline assets into sustained product sales. This is the pivot point. Let's break down the nine blocks of the Business Model Canvas to see exactly how Arrowhead Pharmaceuticals, Inc. (ARWR) is structuring this massive transition.
Arrowhead Pharmaceuticals, Inc. (ARWR) - Canvas Business Model: Key Partnerships
You're looking at the backbone of Arrowhead Pharmaceuticals, Inc.'s strategy: leveraging its RNAi platform through major collaborations to fund its pipeline and de-risk development. This approach brings in significant, non-dilutive capital right when the company is transitioning to commercial stage with REDEMPLO's 2025 FDA approval.
The sheer scale of these deals provides substantial financial ballast. For fiscal year 2025, total operating expenses were approximately $731 million, up from $605 million in fiscal year 2024, driven by higher R&D costs related to late-stage trials and these business development activities.
Here's a breakdown of the key financial and operational terms associated with these major alliances as of late 2025.
Muscular Dystrophy Programs: Sarepta Therapeutics
The global licensing and collaboration agreement with Sarepta Therapeutics (SRPT), which closed in February 2025, is Arrowhead Pharmaceuticals, Inc.'s largest partnership. This deal immediately provided substantial cash flow.
The initial closing terms included:
- An upfront payment of $500 million cash.
- $325 million via Sarepta's purchase of Arrowhead common stock at $27.25 per share.
- A guaranteed payment stream of $250 million paid in annual installments of $50 million over 5 years.
- Potential near-term payments of $300 million tied to enrollment milestones for ARO-DM1.
- Arrowhead also repurchased 2,660,989 shares from Sarepta.
Just recently, in November 2025, Arrowhead earned a $200 million milestone payment from Sarepta for ARO-DM1 (SRP-1003) advancing in its Phase 1/2 study. This followed a prior $100 million milestone payment for ARO-DM1. The ARO-DM1 study is dosing cohort 4 (6 mg/kg) and plans to start cohort 5 (12 mg/kg) in the first quarter of 2026.
The agreement covers multiple programs, including ARO-DUX4 and ARO-MMP7, and allows Sarepta to propose up to six new CNS or muscle targets. Per program, Arrowhead is eligible for development milestones between $110 million and $410 million, and sales milestones between $500 million and $700 million, plus tiered royalties up to the low double digits.
CNS Programs: Novartis
The global licensing and collaboration agreement with Novartis for ARO-SNCA, targeting synucleinopathies like Parkinson's disease, closed in October 2025. This preclinical-stage program brought in immediate cash.
Financial terms for the Novartis deal include:
| Payment Type | Amount |
| Upfront Payment | $200 million |
| Potential Milestone Payments | Up to $2 billion |
| Commercial Royalties | Tiered, up to the low double digits |
Novartis will also select a limited number of additional targets for development using Arrowhead Pharmaceuticals, Inc.'s TRiM platform. Arrowhead anticipates receiving $25 million from Novartis over the next year.
Geographical Licensing: Sanofi for Greater China
In August 2025, Arrowhead Pharmaceuticals, Inc.'s majority-owned subsidiary, Visirna Therapeutics, signed an asset purchase agreement with Sanofi for rights to cardiometabolic candidates, including plozasiran, in Greater China. Plozasiran is designed to reduce apolipoprotein C-III (APOC3) production.
The Sanofi/Visirna deal structure:
- Upfront payment of $130 million.
- Potential regulatory milestones up to $265 million across various indications in mainland China.
- Total potential consideration is $395 million.
The deal covers four cardiometabolic candidates. Plozasiran's Phase 3 trial in Chinese FCS patients met all primary and key secondary endpoints, and the New Drug Application (NDA) was accepted by the China NMPA in January 2025. Plozasiran also received Breakthrough Therapy Designation and Priority Review Designation from the China NMPA. This follows the 2025 FDA approval of plozasiran (REDEMPLO) for FCS.
Out-Licensed Late-Stage Candidates: Amgen and Takeda
Arrowhead Pharmaceuticals, Inc. has out-licensed late-stage candidates, which continue to generate revenue through milestones and royalties.
Olpasiran (Amgen), targeting Lipoprotein(a), was licensed to Amgen in 2016. Arrowhead received an initial $35.0 million upfront, $21.5 million in equity, and $55.0 million in milestones. Arrowhead remains eligible for up to $400 million in milestones from Amgen. Separately, Arrowhead sold its royalty rights on olpasiran to Royalty Pharma for $250 million upfront, with up to $160 million more contingent on milestones.
Fazirsiran (Takeda), for liver disease associated with alpha-1 antitrypsin deficiency, brought an upfront payment of $300.0 million and an additional $40.0 million upon Phase 3 start. Arrowhead is eligible for up to $527.5 million in further milestones. Within the United States, fazirsiran will be co-commercialized under a 50/50 profit sharing structure, while outside the US, Arrowhead receives tiered royalties of 20% to 25% on net sales. Both olpasiran and fazirsiran have reached late-stage pivotal studies.
Contract Research Organizations (CROs)
Arrowhead Pharmaceuticals, Inc.'s clinical execution relies on CROs, though industry-wide spending shows moderation. For 2025, R&D costs were heavily impacted by Phase III trials for REDEMPLO and SHTG, with nearly two-thirds of the clinical trial spend attributed to these late-stage developments. In contrast, R&D spending from 13 large companies, including Novartis, is only expected to increase by 2.2% in 2025.
Arrowhead Pharmaceuticals, Inc. (ARWR) - Canvas Business Model: Key Activities
Research and Development (R&D) of new RNAi therapeutics.
Arrowhead Pharmaceuticals, Inc. reported total operating expenses for fiscal year 2025 were approximately $731 million, an increase of $126 million from fiscal year 2024. This increase was driven by $101 million of higher R&D expenses. Research and development expenses for the twelve months ending June 30, 2025, were $0.568B. The company is spending heavily to push its pipeline forward.
Advancing a deep clinical pipeline of 18+ drug candidates.
Arrowhead Pharmaceuticals, Inc. plans to have 20 individual drug candidates in clinical trials by the end of 2025. The pipeline is split, with approximately half wholly owned and half partnered. Zodasiran represents the fourth investigational RNAi-based candidate developed by Arrowhead to reach late-stage pivotal studies. The company has four Arrowhead discovered candidates currently in pivotal Phase 3 studies as of August 2025.
- The company is advancing its obesity program, focusing on ARO-INHBE and ARO-ALK7 targets.
- Initial data from obesity and muscle programs, including ARO-INHBE and ARO-ALK7, are expected by year-end 2025.
- The company filed to initiate clinical trials for two new investigational therapies, ARO-DIMER-PA and ARO-MAPT.
Commercialization and launch of REDEMPLO (plozasiran) in the US.
The U.S. Food and Drug Administration (FDA) approved REDEMPLO (plozasiran) on November 18, 2025, as an adjunct to diet to reduce triglycerides in adults with Familial Chylomicronemia Syndrome (FCS). The company expects the drug will become available to FCS patients in the U.S. before the end of the year (2025). Arrowhead Pharmaceuticals, Inc. announced the One-REDEMPLO pricing model that creates one consistent price across current and potential future indications. The annual wholesale price for REDEMPLO is $60,000. However, Arrowhead Pharmaceuticals, Inc. does not anticipate substantial financial impact from commercial sales in fiscal year 2026. The company launched Rely On REDEMPLO, a patient support program.
Ongoing refinement of the proprietary TRiM™ delivery platform.
REDEMPLO represents the first FDA-approval for a medicine leveraging Arrowhead Pharmaceuticals, Inc.'s proprietary and differentiated Targeted RNAi Molecule (TRiM™) platform. The TRiM™ platform is now potentially capable of delivering siRNA to seven different cell types in the body. The technology also has the potential to simultaneously silence the expression of two genes in one molecule.
Global business development to secure new licensing agreements.
Revenue for fiscal year 2025 totaled $829 million, driven entirely by license and collaboration agreements. The company secured two significant deals that closed in 2025.
| Partner/Agreement | Upfront/Initial Payment Amount | Total Potential Milestones | FY 2025 Revenue Contribution |
| Sarepta Therapeutics (ARO-DM1, etc.) | $500 million upfront + $325 million stock purchase (closing Feb 2025) | Up to $10 billion + tiered royalties | $697 million |
| Novartis (ARO-SNCA) | $200 million upfront received | Up to $2 billion | $200 million upfront recognized |
| Sanofi/Visirna Therapeutics (Greater China) | $130 million upfront received | Up to $265 million (for plozasiran) | $130 million |
| GSK Milestone | Not specified | Not specified | $2.6 million |
Arrowhead Pharmaceuticals, Inc. also earned a $100 million milestone payment from Sarepta Therapeutics in fiscal quarter 4, 2025. The company is eligible to receive a further $200 million milestone payment from Sarepta by the end of 2025. Arrowhead Pharmaceuticals, Inc. is also eligible to receive development, regulatory, and sales milestone payments of up to $2 billion from Novartis.
- Net cash provided by operating activities was $180 million in fiscal year 2025, up from net cash used of $463 million in 2024.
- Cash and investments totaled $919 million as of September 30, 2025.
- This cash position provides a runway extending into fiscal year 2028.
Arrowhead Pharmaceuticals, Inc. (ARWR) - Canvas Business Model: Key Resources
You're looking at the core assets Arrowhead Pharmaceuticals, Inc. (ARWR) is leaning on as it officially shifts from a development-focused entity to a commercial-stage company. These aren't just abstract concepts; they are concrete, balance-sheet items and validated technologies that underpin future revenue potential.
Proprietary Targeted RNAi Molecule (TRiM™) delivery platform
The TRiM™ platform is the engine behind Arrowhead Pharmaceuticals, Inc.'s success, now validated by its first commercial product. This technology is what allows for the precise delivery of RNA interference (RNAi) molecules to target specific genes. The platform's capability was recently demonstrated with the FDA approval of REDEMPLO, which uses this differentiated delivery system.
The commercial validation of the TRiM platform is tied to significant financial milestones from partnerships:
- The agreement with Novartis includes an upfront payment of $200 million for a preclinical stage siRNA targeting alpha-synuclein, which is to be developed using the TRiM platform.
- Arrowhead Pharmaceuticals, Inc. is eligible to receive milestone payments up to $2 billion from Novartis related to this collaboration.
- The company is also eligible to receive tiered royalties on commercial sales up to low double digits from the Novartis deal.
The platform's success is also evident in the revenue derived from other collaborations, which drove the company's fiscal 2025 performance.
Strong cash and investment position of $919 million as of September 30, 2025.
Liquidity is a major resource, and Arrowhead Pharmaceuticals, Inc. entered the commercial phase with a very healthy balance sheet. This cash position funds ongoing operations and pipeline advancement without immediate financing pressure. This figure represents cash and investments, including available-for-sale securities.
Here's a quick look at the financial strength as of the fiscal year-end:
| Financial Metric | Amount (as of September 30, 2025) |
| Cash and Investments (Total) | $919 million |
| Total Assets | $1.25 billion |
| Stockholders' Equity | $466 million |
| Net Cash Provided by Operating Activities (FY 2025) | $180 million |
| Fiscal 2025 Revenue (Primarily Milestones) | $829.4 million |
Honestly, the swing in operating cash flow-from net cash used of $463 million in fiscal 2024 to net cash provided of $180 million in fiscal 2025-is a direct reflection of securing these large upfront and milestone payments.
Extensive Intellectual Property (IP) portfolio covering RNAi chemistries and delivery.
While the exact count of patents isn't publically detailed here, the value of the IP is demonstrated by the successful navigation of the regulatory landscape and the ability to secure high-value partnerships. The FDA approval of REDEMPLO itself serves as a massive validation of the underlying IP protecting the TRiM chemistry and delivery method.
Key validation points stemming from the IP include:
- FDA approval of REDEMPLO on November 18, 2025.
- REDEMPLO is the first and only FDA-approved siRNA medicine for Familial Chylomicronemia Syndrome (FCS).
- The drug targets a rare disorder affecting an estimated 6,500 people in the U.S.
This IP foundation is what allows Arrowhead Pharmaceuticals, Inc. to command premium deal terms.
Specialized scientific talent in RNA interference and gene silencing.
The transition to a commercial-stage company required building out functions beyond pure R&D, such as regulatory, supply chain, and order-to-cash capabilities. The team's expertise in RNAi is the core human capital asset that developed the platform and navigated the complex clinical path for REDEMPLO.
The scale of the operation in fiscal 2025 required significant investment in personnel and infrastructure, reflected in the operating expenses:
- Fiscal Year 2025 Operating Expenses totaled $731 million.
- This represented an increase of $126 million from fiscal 2024, driven by late-stage trials and commercial preparations.
- The company ended the year with a net loss of only $2 million (or $0.01 per share) for fiscal 2025, a massive improvement from the $599.5 million loss the prior year.
The scientific team's ability to deliver a near breakeven result while launching a product is defintely a testament to resource management.
First FDA-approved product, REDEMPLO, validating the platform.
REDEMPLO (plozasiran) is the tangible proof of concept for the entire Arrowhead Pharmaceuticals, Inc. model. It validates the TRiM platform's ability to move from concept to a market-ready, self-administered therapy.
Specifics on the approved product:
- Administration: Simple subcutaneous injection once every 3 months.
- Indication: Adjunct to diet to reduce triglycerides in adults with FCS.
- Pricing: Unified One-REDEMPLO pricing model at $60,000 per year.
- Clinical Efficacy: Showed a median 70% triglyceride reduction from baseline in Phase 3 PALISADE study.
The company's common shares outstanding as of the end of the quarter were 135.7 million.
Arrowhead Pharmaceuticals, Inc. (ARWR) - Canvas Business Model: Value Propositions
You're looking at the core value Arrowhead Pharmaceuticals, Inc. is delivering now that they've finally transitioned from a pure-play R&D firm to a commercial-stage company with their first FDA approval. The value proposition centers entirely on the power and reach of their proprietary Targeted RNAi Molecule (TRiM™) platform.
Deep, durable silencing of disease-causing genes via RNAi.
The fundamental value is the ability to trigger RNA interference (RNAi) for rapid, deep, and durable knockdown of target genes. This isn't just theory anymore; we saw it with REDEMPLO (plozasiran), which targets apoC-III production in the liver. In the Phase 3 PALISADE study, the 25 mg dose of REDEMPLO achieved a median triglyceride reduction of -80% from baseline. Compare that to the pooled placebo group, which only saw a -17% median reduction. That's the difference between disease control and minimal effect. Plus, this silencing is designed to be durable, allowing for self-administration at home only once every three months.
Tissue-specific targeting beyond the liver using TRiM™.
The TRiM™ platform is what lets Arrowhead Pharmaceuticals move past the liver-centric limitations of earlier RNAi approaches. The platform now has the potential to address seven different cell types across the body. For instance, preclinical work on ARO-MAPT, targeting tauopathies like Alzheimer's disease, showed delivery across the blood-brain-barrier, achieving better than 75% knockdown of tissue level MAPT mRNA in the Central Nervous System (CNS) in non-human primate studies following subcutaneous injection. Furthermore, for adipose tissue targeting, preclinical studies achieved target gene silencing of greater than 90% with a duration of six months after a single dose in non-human primates.
First-in-class siRNA medicine, REDEMPLO, for rare diseases like FCS.
REDEMPLO is the first and only small interfering RNA (siRNA) medicine approved by the FDA for adults with Familial Chylomicronemia Syndrome (FCS), a rare genetic disorder affecting an estimated 6,500 people in the U.S. This approval marks a transformational milestone, moving Arrowhead Pharmaceuticals into commercialization after decades of development. The value here is providing a novel, first-in-class option where limited therapies existed. The clinical data supported this first-in-class status by showing a lower numerical incidence of acute pancreatitis compared to placebo in the PALISADE trial. This is a huge value driver, especially when you look at the competitive landscape.
Here's a quick look at how REDEMPLO stacks up against the competitor that launched last year, Tryngolza, based on available trial data and announced pricing as of late 2025:
| Value Metric | REDEMPLO (Plozasiran) | Tryngolza (Olezarsen) |
| Median TG Reduction (25mg/Relevant Dose) | -80% | Approximately 70% (Comparative Trial Data) |
| Dosing Frequency | Once every three months | Not specified in comparison data |
| FDA Approval Date | November 18, 2025 | December 2024 |
| Estimated 2025 Sales (Competitor) | N/A (New Launch) | $85 million to $95 million |
Potential to treat previously undruggable targets across multiple therapeutic areas.
The platform's flexibility suggests a vast addressable market beyond FCS. You see this potential in their pipeline expansion. For instance, ARO-DIMER-PA is designed to silence two genes simultaneously (PCSK9 and APOC3) in one molecule for mixed hyperlipidemia, a condition affecting approximately 20 million people in the U.S. This dual-targeting capability in a single RNAi molecule is a significant technological leap. Furthermore, the collaboration with Novartis for ARO-SNCA, targeting alpha-synuclein for synucleinopathies like Parkinson's Disease, shows the platform's utility in CNS targets previously considered difficult to reach systemically.
Simplified manufacturing and potential for improved safety profile.
The TRiM™ platform's structural simplicity, achieved through ligand-mediated delivery, is key to manufacturing efficiency and safety. The FDA approval of REDEMPLO, which leverages this platform, marks Arrowhead Pharmaceuticals' transition to a commercial entity, supported by a strong balance sheet. As of September 30, 2025, the company reported total cash resources of $781.5 million, providing an estimated 24 months of cash runway. Financially, the fiscal year 2025 revenue hit $829.4 million-a monumental jump from $3.6 million in fiscal 2024-largely due to milestone payments, including $300 million from Sarepta Therapeutics and a $200 million upfront payment from Novartis. This financial strength underpins the ability to execute on commercialization and further pipeline development, which inherently includes optimizing the safety profile of future candidates. The company narrowed its annual net loss to $1.6 million in FY 2025, a massive improvement from the $599.5 million loss the prior year.
The platform's value propositions can be summarized by its current achievements and future potential:
- First FDA-approved medicine leveraging the TRiM™ platform.
- Preclinical CNS knockdown better than 75% with CNS delivery.
- ARO-DIMER-PA targets two genes in one molecule.
- Fiscal Year 2025 revenue reached $829.4 million.
- Cash reserves stood at $781.5 million as of September 30, 2025.
Finance: draft 13-week cash view by Friday.
Arrowhead Pharmaceuticals, Inc. (ARWR) - Canvas Business Model: Customer Relationships
You're transitioning from a pure development-stage company to one with a commercial product, and that changes everything about how Arrowhead Pharmaceuticals, Inc. interacts with its key stakeholders. The relationships now have to support both the pipeline and the first revenue-generating asset, REDEMPLO.
Dedicated patient support program, Rely On REDEMPLO, for eligible patients.
The launch of REDEMPLO, approved by the U.S. Food and Drug Administration (FDA) on November 18, 2025, was immediately followed by the rollout of the Rely On REDEMPLO patient support program. This program is designed to shepherd patients through every stage of their treatment journey with the siRNA medicine. For the estimated 6,500 people in the U.S. living with genetic or clinical Familial Chylomicronemia Syndrome (FCS), this support is critical, especially since REDEMPLO is self-administered at home via a subcutaneous injection once every three months. A key component of this relationship management is the provision of financial assistance options for eligible patients. Furthermore, Arrowhead Pharmaceuticals announced the One-REDEMPLO pricing model, establishing one consistent price across current and potential future indications, set at $60,000 per year. This unified pricing strategy is a direct attempt to simplify the payer and patient experience, moving away from variable pricing based on indication. That's a clear signal about how they view long-term patient commitment.
High-touch, direct engagement with specialist physicians (e.g., lipidologists).
Commercial success for REDEMPLO hinges on deep engagement with the specialized medical community that manages FCS. The prescriber base is tightly defined, comprising specialist physicians such as lipidologists, endocrinologists, preventive cardiologists and internal medicine physicians with a focus on lipid disorders. To ensure the drug gets into the hands of those who need it quickly after the November 2025 approval, Arrowhead Pharmaceuticals is targeting approximately 5,000 health care professionals through direct, personal engagement at launch. This high-touch approach is necessary because these specialists often operate within complex multidisciplinary teams that include gastroenterologists and specialized dietitians, all of whom need to be educated on the first and only FDA-approved siRNA medicine for FCS.
Strategic, long-term collaboration management with large pharma partners.
For a company like Arrowhead Pharmaceuticals, managing strategic, long-term collaborations is as much a customer relationship as managing patients; these partners fund significant portions of the pipeline. The fiscal year 2025 results clearly show the financial weight of these relationships, with full-year revenue hitting $829.4 million, driven entirely by these agreements. You need to track these milestones closely, as they directly impact the balance sheet, which stood at $781.5 million in total cash resources as of September 30, 2025. Here's the quick math on the two major recent deals:
| Partner | Program/Asset | Upfront Payment Received | Total Potential Milestones |
| Sarepta Therapeutics | ARO-DM1 (for DM1) | Not specified for upfront, but earned $300 million in FY2025 milestones (including a recent $200 million payment). | Not specified in detail, but previously earned a $100 million milestone. |
| Novartis | ARO-SNCA (for synucleinopathies) and other targets | $200 million | Up to $2 billion, plus tiered royalties up to the low double digits. |
Managing these relationships means ensuring pipeline progress meets contractual obligations, like the recent $200 million milestone earned from Sarepta Therapeutics following a drug safety committee review for ARO-DM1.
Regulatory and medical affairs engagement with the FDA and global agencies.
The relationship with regulatory bodies is perhaps the most critical for a biotech transitioning to commercial status. The successful FDA approval of REDEMPLO on November 18, 2025, followed the FDA's acceptance of the New Drug Application (NDA) on January 17, 2025, with a PDUFA target action date of November 18, 2025. This approval was based on the Phase 3 PALISADE study, which showed a median triglyceride reduction of -80% from baseline. Beyond the initial FCS indication, Arrowhead Pharmaceuticals plans to submit approval applications for plozasiran to other regulatory authorities in 2025, and ongoing late-stage studies, like SHASTA-3 and SHASTA-4, are designed to support a supplemental NDA for broader use, with top-line data expected in the third quarter of 2026. This continuous, data-driven engagement with the FDA and global agencies is what unlocks the next phase of commercial opportunity.
Finance: review the cash runway projection into fiscal 2028 based on current burn rate and expected milestone receipts by end of Q1 2026.
Arrowhead Pharmaceuticals, Inc. (ARWR) - Canvas Business Model: Channels
You're transitioning Arrowhead Pharmaceuticals, Inc. from a development focus to a commercial entity with REDEMPLO. Here's how they are getting the product and the data to the market as of late 2025.
Direct Commercial Sales Force for the US Market Launch of REDEMPLO
Arrowhead Pharmaceuticals, Inc. transitioned to a commercial-stage company following the U.S. FDA approval of REDEMPLO (plozasiran) on November 19, 2025, for familial chylomicronemia syndrome (FCS). The company stated its commercial team was prepared to 'hit the ground running' upon approval. The launch is supported by the Rely On REDEMPLO patient support program.
The pricing strategy channels the drug through a unified One-REDEMPLO pricing model, setting a yearly Wholesale Acquisition Cost (WAC) at $60,000 per patient, regardless of future indications. This is significantly lower than the competitor Tryngolza's WAC of $595,000. The estimated US population for FCS is approximately 6,500 people.
Specialty Pharmacies and Distributors for Drug Fulfillment (Drug in Channel)
Following the FDA approval, Arrowhead Pharmaceuticals, Inc. confirmed they have drug in channel, indicating the fulfillment pathway is active. REDEMPLO is self-administered at home via a subcutaneous injection once every three months. While specific specialty pharmacy partners aren't detailed, the company relies on this network for drug fulfillment for its first commercial product.
Out-Licensing Partners (e.g., Sanofi, Amgen) for Ex-US Market Access
Business development and licensing remain critical to the Arrowhead Pharmaceuticals, Inc. model, providing significant non-product revenue inflows. The fiscal year 2025 revenue totaled $829 million, driven entirely by these agreements with Sarepta, Sanofi, and GSK.
Here are the key financial terms and partner activities as of late 2025:
| Partner | Program/Scope | Upfront Payment (USD) | Total Potential Milestones (USD) | Royalty/Other Terms |
| Sarepta Therapeutics | CNS/Muscle targets (ARO-DM1 milestone earned) | $500 million (cash) + $325 million (equity) | Up to $10 billion total (per program terms) | Tiered royalties up to the low double digits. |
| Novartis | ARO-SNCA (Parkinson's) + additional targets (TRiM platform) | $200 million | Up to $2 billion | Tiered royalties up to the low double digits. |
| Sanofi (Visirna via) | REDEMPLO in Greater China | N/A (Visirna received $130 million upfront) | Up to $265 million (for plozasiran milestones) | N/A |
| Takeda/Amgen | Fazirsiran / Olpasiran | N/A (Milestones/Royalties from prior deals) | N/A | N/A |
The Sarepta deal included a $325 million equity investment priced at $27.25 per share, representing a 35% premium. Arrowhead also earned a $200 million milestone from Sarepta in the period leading up to the earnings call.
Scientific Publications and Medical Conferences to Disseminate Clinical Data
Dissemination of clinical data is channeled through participation in major medical meetings. Arrowhead Pharmaceuticals, Inc. was scheduled to present data at several key events in late 2025, supporting both the approved indication and pipeline expansion efforts.
Key participation and data presentation channels include:
- American Heart Association (AHA) Scientific Sessions 2025 (November 7-10, 2025).
- American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting 2025 (November 7-11, 2025).
- Jefferies Global Healthcare Conference 2025 (November 17-20, 2025).
- TD Cowen's Virtual Treatment Advancements in Obesity & Related Disorders (November 24, 2025).
Specific data presented included a poster presentation on the Phase 3 study of Zodasiran at AHA, and multiple presentations on Fazirsiran at AASLD.
For pipeline expansion, enrollment is complete for the SHASTA-3 and SHASTA-4 Phase III trials, with top-line data expected in the third quarter of 2026, supporting a supplemental New Drug Application submission planned before the end of 2026.
The company's cash and investments stood at $919 million as of the earnings announcement date, following significant licensing inflows.
Arrowhead Pharmaceuticals, Inc. (ARWR) - Canvas Business Model: Customer Segments
You're looking at the customer base for Arrowhead Pharmaceuticals, Inc. (ARWR) as they transition from a pure R&D focus to having their first commercial product, REDEMPLO, on the market in late 2025. This segment breakdown shows who is buying their technology or who is the patient population for their approved/pipeline drugs.
The primary patient segments are defined by rare and severe lipid disorders, which are the initial focus for their FDA-approved medicine, REDEMPLO (plozasiran).
- Patients with Familial Chylomicronemia Syndrome (FCS), an estimated 6,500 people in the U.S.
- Patients with Severe Hypertriglyceridemia (SHTG) at high risk of acute pancreatitis, estimated at approximately 1 million in the U.S.
- Patients with Homozygous Familial Hypercholesterolemia (HoFH) targeted by zodasiran, with its Phase III trial enrolling about 60 subjects over age 12.
The pricing for the approved drug, REDEMPLO, is set uniformly across indications, which is a key factor for payer and physician adoption.
| Customer Segment Detail | Relevant Metric | Value/Amount |
| FCS Patient Population (U.S. Estimate) | Genetic or Clinical FCS Patients | 6,500 |
| REDEMPLO Annual WAC | Wholesale Acquisition Cost | $60,000 |
| High-Risk SHTG Population (U.S. Estimate) | Triglycerides $\geq$ 880 mg/dL or $>$ 500 mg/dL with prior pancreatitis | Approx. 1 million |
| HoFH Trial Enrollment (YOSEMITE) | Subjects Randomized | Approx. 60 |
Specialist physicians, such as endocrinologists and cardiologists, are the prescribers, directly interfacing with the FCS patient segment, which saw REDEMPLO achieve median triglyceride reductions around 80% from baseline in the PALISADE Phase III study.
The third major customer segment involves large pharmaceutical and biotechnology companies who license Arrowhead Pharmaceuticals, Inc. (ARWR)'s Targeted RNAi Molecule (TRiM™) platform technology. These partnerships are critical, as they drove the vast majority of the company's revenue in fiscal year 2025.
- Total Fiscal Year 2025 Revenue: $829 million (or $829.4 million).
- Revenue derived entirely from license and collaboration agreements.
- Fiscal Year 2025 Net Loss narrowed to $2 million (or loss of $0.01 per share), compared to a loss of $599 million in fiscal 2024.
Specific high-value partners define this segment, providing significant upfront payments and milestone revenue.
| Partner Company | Agreement/Milestone Event (FY2025) | Financial Impact (FY2025 Revenue/Payment) |
| Sarepta Therapeutics | Milestone payment earned for ARO-DM1 (SRP-1003) | $300 million total milestone earned in FY2025 (including $200 million in Q4 FY2025) |
| Novartis | Upfront payment for ARO-SNCA collaboration | $200 million upfront payment |
| Sanofi | Revenue recognized from license agreement | $130 million |
| Novartis (Total Potential) | Future milestone payments | Up to $2 billion |
| Sarepta Therapeutics (Total FY2025) | Revenue recognized from arrangement | Roughly $697 million |
The company's cash position also reflects the importance of these corporate customers; cash and investments totaled $919 million as of September 30, 2025.
Arrowhead Pharmaceuticals, Inc. (ARWR) - Canvas Business Model: Cost Structure
You're looking at the cost side of Arrowhead Pharmaceuticals, Inc. (ARWR) as they transition from a pure development company to one with a commercial product, REDEMPLO. The spending profile is dominated by the high burn rate required to advance their RNAi pipeline.
Dominant Research and Development (R&D) expenses represent the largest cost driver. For the fiscal year 2025 ended September 30, 2025, Research and Development expenses totaled $607.2 million (reported as $607,159 thousand). This compares to $505.9 million in the prior fiscal year.
The General and Administrative (G&A) costs are also scaling up, reflecting the commercialization build-out now that REDEMPLO is approved. For FY2025, General and Administrative expenses were $123.9 million (reported as $123,943 thousand). This is a notable increase from the G&A of $98.8 million (reported as $98,761 thousand) in FY2024. Total operating expenses for FY2025 reached $731.1 million (reported as $731,102 thousand).
The R&D spend is heavily weighted toward late-stage work. Here's a breakdown of where that investment is going:
- Costs to run clinical trials, including clinical manufacturing costs.
- Expense related to active preclinical-stage programs.
- Late-stage development of plozasiran and SHTG studies.
Specifically, nearly two-thirds (2/3) of the clinical trial spend in fiscal year 2025 was attributed to the late-stage development of plozasiran and the SHTG registrational studies. Zodasiran is also in a Phase 3 clinical trial.
Manufacturing and supply chain costs are now becoming more tangible with the launch of REDEMPLO. The company established a single pricing structure for REDEMPLO, setting the annual wholesale acquisition cost (WACC) at $60,000. Clinical manufacturing costs were noted as a key driver within the overall R&D spend.
Revenue-generating activities, primarily from partnerships, help offset these costs, but the upfront and milestone payments are distinct from the core operating expenses. Consider these key non-operating/partnership-related cash inflows that impact the overall financial structure:
| Revenue/Payment Type | Amount (USD) | Source/Context |
| Novartis Upfront Payment (ARO-SNCA) | $200 million | Global licensing and collaboration agreement |
| Sarepta Milestone Payments Earned (Total) | $300 million | Milestones for ARO-DM1 Phase 1/2 study |
| Sanofi Upfront Payment (Visirna/Greater China) | $130 million | Asset purchase agreement for four cardiometabolic candidates |
Intellectual property maintenance and licensing fees are an ongoing, though less detailed, component of the cost structure, as the company continues to protect and expand its proprietary Targeted RNAi Molecule (TRiM™) platform.
Finance: draft 13-week cash view by Friday.
Arrowhead Pharmaceuticals, Inc. (ARWR) - Canvas Business Model: Revenue Streams
You're looking at the core engine that powers Arrowhead Pharmaceuticals, Inc. (ARWR) right now: how the money actually comes in. For a company transitioning from pure R&D to commercial stage, the revenue mix tells the whole story. As of late 2025, it's overwhelmingly about partnerships.
Collaboration and License Revenue Dominance
The financial results for fiscal year 2025 show that licensing deals are the primary revenue driver. Collaboration and license revenue totaled $829.4 million for FY2025. This massive figure represents the company's success in monetizing its proprietary Targeted RNAi Molecule (TRiM™) platform through external partners. This revenue stream is critical for funding the internal pipeline development, especially as the company manages its first commercial launch.
The total FY2025 revenue of $829 million was driven entirely by these license and collaboration agreements with partners like Sarepta Therapeutics, Sanofi, and GlaxoSmithKline (GSK). This is a stark contrast to the $3.55 million reported in fiscal 2024.
Upfront and Milestone Payments from Partners
A significant portion of the 2025 revenue came from hitting specific targets within those agreements. You can see the major components contributing to that top line:
- The agreement with Novartis, announced in September 2025 for ARO-SNCA, included an upfront payment of $200 million.
- Arrowhead Pharmaceuticals, Inc. earned a $200 million milestone payment from Sarepta Therapeutics following a Drug Safety Committee review and subsequent authorization to dose escalate for ARO-DM1.
- The company also earned a $100 million milestone from Sarepta related to the first of two pre-specified enrollment targets for ARO-DM1, which was satisfied by a combination of $50 million in cash and $50 million worth of Arrowhead common stock bought back from Sarepta.
Here's a quick look at the major recognized collaboration revenue components for FY2025:
| Partner | FY2025 Revenue Component | Amount (Millions USD) |
| Sarepta Therapeutics | Ongoing Recognition of Initial Consideration | $587 |
| Sarepta Therapeutics | Milestone Payment (ARO-DM1) | $94 |
| Sanofi | Upfront/Consideration Recognition | $130 |
| GSK | Milestone Payment | $2.6 |
The total recognized revenue from Sarepta Therapeutics for FY2025 was approximately $697 million. That's a lot of non-dilutive cash flow.
Royalty Payments on Out-licensed Products
While specific royalty dollar amounts for FY2025 aren't broken out separately from the milestone/recognition figures, the structure is in place for future passive income. For instance, the Novartis deal makes Arrowhead Pharmaceuticals, Inc. eligible to receive tiered royalties on commercial sales up to the low double digits. Similarly, the Sarepta agreement includes potential royalties on commercial sales up to the low double digits. These payments will become a more visible stream once out-licensed products reach the market.
Initial Product Sales of REDEMPLO
Arrowhead Pharmaceuticals, Inc. transitioned into a commercial-stage company with the FDA approval of REDEMPLO (plozasiran) in November 2025 for familial chylomicronemia syndrome (FCS). FCS affects an estimated 6,500 people in the U.S. The company launched the product with a unified pricing model of $60,000 per year for current and future indications. Analyst estimates suggest initial product sales for FCS in 2025 were around $0.5 million. Honestly, the expectation is that commercial sales will have no substantial impact on 2026 financials, with growth expected post-2026 as they pursue label expansion into severe hypertriglyceridemia (sHTG).
Ongoing Revenue Recognition from Existing Deals
The revenue recognition schedule from the massive February 2025 Sarepta deal provides a steady baseline. As noted, $587 million relates to the ongoing recognition of initial Sarepta consideration in FY2025. Furthermore, the Sarepta deal includes a structure for future payments:
- $250 million to be paid in annual installments of $50 million over 5 years, with the first payment due in February 2026.
- Potential milestone payments totaling approximately $10 billion are also possible from the Sarepta agreement.
Finance: draft 13-week cash view by Friday.
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