Arrowhead Pharmaceuticals’ Earnings Call Highlights FDA Approval and Strong Financials

Arrowhead Pharmaceuticals, Inc. ((ARWR)) has held its Q4 earnings call. Read on for the main highlights of the call.

The recent earnings call for Arrowhead Pharmaceuticals, Inc. was marked by a strong positive sentiment, underscored by significant achievements such as the FDA approval of Rodemplo and robust financial performance. The company is making a successful transition to a commercial stage, although it faces some challenges in program timelines and regulatory claims that need to be addressed.

FDA Approval of Rodemplo

Arrowhead Pharmaceuticals announced a major milestone with the FDA approval of Rodemplo, its first FDA-approved medicine. This approval marks a significant transition for the company as it moves into the commercial stage. Rodemplo is approved as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), highlighting the company’s innovative capabilities in addressing unmet medical needs.

Robust Financial Performance

The company reported a near breakeven result with a net loss of $2 million for fiscal year 2025, a remarkable improvement from a net loss of $599 million in fiscal year 2024. This turnaround was driven by $829 million in revenue from license and collaboration agreements, showcasing Arrowhead’s strong financial management and strategic partnerships.

Significant Milestone Payments

Arrowhead Pharmaceuticals secured a $200 million milestone payment from Sarepta and a $200 million upfront payment from Novartis for licensing collaboration agreements. These payments, along with potential future milestone payments of up to $2 billion, reflect the company’s successful collaborations and potential for future growth.

Pipeline Advancements

The company is making significant progress in its pipeline programs, including Phase III trials for Zidaziran and Aerodimer PA. Additionally, Arrowhead is expanding into the CNS space with ARO MAPT for tauopathies and Alzheimer’s disease, demonstrating a broad and diverse pipeline that promises future innovations.

Challenges in Obesity Program Timelines

Arrowhead faces challenges with delays in early data sharing from its obesity programs ARO I and HBE, and ARO AP7, now expected in early 2026. These delays are attributed to travel schedules and holidays, indicating potential setbacks in program timelines that the company will need to manage.

Uncertainty in Pancreatitis Risk Reduction Claim

The company has not yet engaged with the FDA regarding a pancreatitis risk reduction claim for Rodemplo, particularly for the high-risk SHTG patient population. This uncertainty presents a regulatory challenge that Arrowhead will need to address to fully capitalize on Rodemplo’s potential.

Forward-Looking Guidance

Arrowhead Pharmaceuticals provided significant guidance for the future, emphasizing the FDA approval of Rodemplo with a $60,000 annual WAC price. The company anticipates completing the Shasta 3 and Shasta 4 Phase III studies by mid-2026, with top-line data expected in the second half of 2026. Plans to submit an sNDA by the end of 2026 were also announced. Financially, Arrowhead reported fiscal year 2025 revenue of $829 million, supported by a cash runway extending into fiscal year 2028. The company remains optimistic about its late-stage pipeline and expects multiple data readouts in 2026.

In summary, Arrowhead Pharmaceuticals’ earnings call conveyed a strong positive outlook, driven by key achievements such as the FDA approval of Rodemplo and robust financial results. While the company faces challenges in program timelines and regulatory claims, its strategic partnerships and diverse pipeline position it well for future growth and innovation.