Arrowhead Pharmaceuticals (NasdaqGS:ARWR) Q1 2026 Earnings call February 05, 2026 04:30 PM ET Company ParticipantsAndrea Newkirk - SVP of Biotechnology Equity ResearchAndy Davis - SVP and Head of Global Cardiometabolic FranchiseChris Anzalone - President and CEODan Apel - CFOEdward Tenthoff - Managing DirectorJames Hamilton - Chief Medical Officer and Head of R&DJason Gerberry - Managing DirectorJoseph Thome - Managing DirectorMani Foroohar - Managing DirectorMike Ulz - Executive DirectorPatrick Trucchio - ...

Company Overview - Arrowhead Pharmaceuticals, Inc. is a leading RNAi-focused biotechnology company, with its flagship candidate plozasiran targeting the ApoC3 gene to reduce plasma triglyceride levels [2] - The company utilizes its proprietary TRiM™ platform for low-dose, quarterly subcutaneous injections, which allows for the silencing of ApoC3 in liver cells [2] Pipeline and Development - A New Drug Application for plozasiran has been filed for Familial Chylomicronemia Syndrome (FCS), with a PDUFA action date set for November 18, 2025, while Phase 3 trials are ongoing for Severe Hypertriglyceridemia (sHTG) [3] - Arrowhead is also advancing other pipeline candidates, including fazirsiran for Alpha-1 antitrypsin deficiency and early-stage obesity programs ARO-INHBE and ARO-ALK7, demonstrating the versatility of its RNAi platform [3] Financial Position - The company has a robust balance sheet with approximately $900 million in cash and equivalents, providing sufficient funding for its clinical programs [4] - Revenue is primarily generated from partnerships, with recent payments from Sanofi and Sarepta helping to offset high R&D expenditures, which reached $162.4 million in Q3 FY2025 [4] Market Opportunity and Competitive Advantage - Arrowhead's market opportunity is significant, covering cardiometabolic, obesity, and emerging CNS indications, with the TRiM™ delivery platform offering low-frequency dosing and the ability to target novel genes [5] - Near-term catalysts include the PDUFA decision for plozasiran in FCS, sHTG trial readouts, milestone payments, and data from early obesity and CNS programs, positioning Arrowhead for potential value creation and long-term growth [5]

Arrowhead Pharmaceuticals Conference Call Summary Company Overview - **Company**: Arrowhead Pharmaceuticals (NasdaqGS:ARWR) - **Focus**: Development of obesity therapeutics, specifically targeting the activin E ALK7 pathway and its implications for metabolic diseases Key Points from the Call Industry and Market Context - **Obesity Treatment Landscape**: The call highlighted the evolving understanding of obesity as a multifaceted disease requiring diverse treatment approaches, including pharmacotherapy, surgical options, and lifestyle changes [2][4][5] - **Unmet Needs**: There is a significant unmet need in treating obesity, particularly in patients with Type 2 diabetes, who often do not respond well to existing therapies [5][14][24] Clinical Trials and Results - **ARO-INHBE and ARO-ALK7**: The call presented interim results from Phase I and II studies of two obesity candidates, ARO-INHBE and ARO-ALK7, focusing on their efficacy and safety [2][3][30] - **Interim Results**: - ARO-INHBE demonstrated a mean maximal reduction of activin E by 85% at a 400 mg dose, leading to a 10% reduction in visceral fat and a 38% reduction in liver fat after a single dose [20][34] - In combination with tirzepatide, ARO-INHBE achieved a 9.4% weight loss in obese diabetic patients, compared to 4.8% with tirzepatide alone [25][35] - ARO-ALK7 showed an 88% mean reduction in ALK7 mRNA after a single dose, with a 14.1% placebo-adjusted reduction in visceral fat observed at week eight [32][36] Mechanism of Action - **Activin E ALK7 Pathway**: The pathway is implicated in regulating visceral adiposity, and silencing its expression may lead to improved metabolic outcomes [17][18][27] - **Combination Therapy**: The combination of ARO-INHBE with tirzepatide is seen as a promising approach to enhance weight loss and metabolic health in patients with obesity and Type 2 diabetes [24][35] Safety and Tolerability - **Safety Profile**: ARO-INHBE and ARO-ALK7 were reported to be well tolerated, with most treatment-emergent adverse events (TEAEs) being mild and no significant adverse trends in laboratory values [27][33] Future Directions - **Next Steps**: Arrowhead plans to expand its studies, including increasing patient numbers and exploring combination therapies with other GLP-1 drugs [38][39] - **Regulatory Pathway**: Discussions regarding the regulatory pathway for ARO-INHBE and ARO-ALK7 are ongoing, with a focus on combination therapies for diabetic patients [51][52] Additional Insights - **Research and Development**: Arrowhead is exploring additional targets in obesity and metabolic disorders, including liver and adipose dimers capable of silencing multiple genes with a single drug [39][40] - **Commercialization Plans**: The company is transitioning to a commercial stage with its first sales expected in the FCS patient population, with further studies planned to support label expansion [40][41] Conclusion Arrowhead Pharmaceuticals is making significant strides in the development of innovative obesity therapeutics, with promising interim results from its clinical trials. The focus on the activin E ALK7 pathway and combination therapies positions the company well in addressing the unmet needs in obesity treatment, particularly for patients with Type 2 diabetes. The safety and efficacy data presented suggest a strong potential for these candidates in future therapeutic paradigms.

Group 1: Key Policies and Measures - Hubei Province's Medical Insurance Bureau and Health Commission launched 18 measures to support the high-quality development of innovative drugs, covering key aspects such as R&D support, inclusion in the medical insurance catalog, clinical application promotion, and strengthening payment systems [1][2][5] - The measures aim to alleviate public concerns regarding medical treatment and medication, while also establishing a solid foundation for the health industry in central China [1][5] Group 2: R&D and Innovation Support - The new measures extend the payment model from the end of the insurance process to the R&D phase, assisting pharmaceutical companies and research institutions in overcoming challenges and accelerating the market entry of effective drugs [2] - The initiative encourages commercial health insurance to invest in long-term capital through funds, alleviating the financial pressure on R&D for companies [2] Group 3: Access and Reimbursement - A dual-channel support system combining medical insurance and commercial insurance is being established to ensure innovative drugs are more accessible to the public [3] - The medical insurance department is committed to including all innovative drugs in the national medical insurance catalog and providing early intervention for eligible local innovative drugs [3] Group 4: Clinical Application and Training - The medical insurance department is optimizing processes to expedite the entry of innovative drugs into hospitals and directly to patients, including a green channel for drug listing and a two-month deadline for medical institutions to discuss new drug entries [4] - Training for healthcare professionals on the clinical use of innovative drugs will be conducted to ensure effective application and outcomes [4] Group 5: Market Expansion and Global Reach - The measures aim to create a multi-layered payment guarantee network, encouraging commercial insurance and mutual aid organizations to include innovative drugs in their coverage [5] - Hubei Province is actively promoting its innovative drugs in global markets, particularly in countries along the Belt and Road Initiative, enhancing the international influence of Hubei's pharmaceutical industry [5] Group 6: Commercial Insurance Directory - The first commercial health insurance innovative drug directory was published, focusing on high-value drugs that exceed the basic medical insurance's scope, including high-priced cancer drugs and gene therapies [6][7] - A total of 121 drug names were reviewed for inclusion, with 19 drugs from 18 innovative pharmaceutical companies successfully added to the directory, indicating a selection rate of approximately 15.7% [6][7] Group 7: CAR-T Therapies and Market Impact - Five CAR-T therapies were included in the first commercial health insurance innovative drug directory, which is expected to significantly reduce patient out-of-pocket expenses and improve accessibility [8][13] - The inclusion of CAR-T products is anticipated to have a positive ripple effect across the entire industry, enhancing market coverage and patient access [8][13]

Core Insights - Arrowhead Pharmaceuticals (ARWR) has significant upcoming events, including the PDUFA date for plozasiran for treating familiar chylomicronemia syndrome (FCS) and the expected release of fiscal Q4 2025 results [2] Company Developments - The PDUFA date for plozasiran is scheduled for tomorrow, indicating a critical regulatory milestone for Arrowhead Pharmaceuticals [2] - Fiscal Q4 2025 results are anticipated next week, which may provide insights into the company's financial performance and future outlook [2] Investment Focus - The Growth Stock Forum, led by a former stockbroker, emphasizes identifying growth and biotech stocks with substantial growth potential, focusing on risk-adjusted returns [2]

Core Insights - Arrowhead Pharmaceuticals (ARWR) has significant upcoming events, including the PDUFA date for plozasiran for treating familiar chylomicronemia syndrome (FCS) and the release of fiscal Q4 2025 results [2] Company Developments - The PDUFA date for plozasiran is scheduled for tomorrow, indicating a critical regulatory milestone for Arrowhead Pharmaceuticals [2] - Fiscal Q4 2025 results are anticipated next week, which may provide insights into the company's financial performance and future outlook [2] Investment Focus - The Growth Stock Forum, led by a former stockbroker, emphasizes identifying growth and biotech stocks with substantial growth potential, focusing on risk-adjusted returns [2]

Core Viewpoint - Arrowhead Pharmaceuticals, Inc. has filed a Complaint for Declaratory Judgment against Ionis Pharmaceuticals, Inc. to declare the invalidity of Ionis's U.S. Patent No. 9,593,333 and assert that Arrowhead's planned commercialization of investigational plozasiran does not infringe this patent [1] Company Summary - Arrowhead Pharmaceuticals is currently under FDA review for its investigational drug plozasiran [1] - The company intends to vigorously defend its position regarding the patent dispute with Ionis Pharmaceuticals [1] Industry Context - The legal action highlights ongoing patent disputes within the pharmaceutical industry, particularly concerning investigational drugs and their commercialization [1]

Core Insights - The company is preparing for a busy 6 to 9 months ahead, focusing on key clinical developments and transitions [2] Group 1: Clinical Developments - The company plans to bring MAPT, its first CNS drug administered via subcutaneous injection, to the clinic [2] - Following MAPT, the company will introduce its first dimer, the PCSK9 APOC3 dimer, which is expected to be a significant tool against atherosclerotic cardiovascular disease (ASCVD) [2] Group 2: Regulatory and Data Milestones - A major event is the PDUFA date for plozasiran in November, marking a transition from an R&D-only company to one that is also commercial [3] - The company anticipates data releases for INHBE and ALK7 related to obesity, with additional ALK7 data expected in the first half of 2026, approximately 6 months behind INHBE in dosing [3]