ARWR

This article first appeared on GuruFocus. Net Loss: $194.3 million, or a loss of $1.36 per share, for the fiscal 2026 third quarter ended June 30, 2026. Revenue: Approximately $75 million for the quarter, up from $28 million in the prior year quarter. Commercial Revenue: Approximately $2.4 million from Redemplo sales, more than double the approximately $1 million recorded in fiscal quarter two. Collaboration Revenue: Approximately $26 million from Sarepta, $20 million from Novartis, $25 million from Madrigal, and $1.2 million from Sanofi. Total Operating Expenses: Approximately $245 million, compared to $193 million in the prior year quarter. R&D Expense: Approximately $198 million, up $36 million year-over-year. SG&A Expense: Approximately $47 million, up $16 million year-over-year. Cash and Investments: Approximately $1.6 billion as of June 30, 2026. Common Shares Outstanding: 141.1 million at quarter end. Priority Review Voucher: $215 million payment expected in fiscal fourth quarter following HSR clearance. Warning! GuruFocus has detected 7 Warning Signs with ARWR. Is ARWR fairly valued? Test your thesis with our free DCF calculator. Release Date: August 04, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Positive top-line Phase III results from SHASTA-3 and SHASTA-4 studies, with both meeting primary and all pre-specified secondary endpoints, showing median triglyceride reductions of 79% and 81%. Significant reduction in acute pancreatitis events, with a 78% reduction in the broad SHTG population and a 100% reduction in the highest-risk subgroup. Favorable safety and tolerability profile with no new safety signals, no clinically meaningful liver enzyme changes, no hypersensitivity, and no thrombocytopenia signal. Strong commercial momentum in the FCS launch, with prescriptions more than doubling quarter-over-quarter and over 400 unique prescribers. Expansion of regulatory approvals for Redemplo to five geographies, including the EU, Australia, Canada, China, and the U.S., with a unique label covering clinically diagnosed FCS patients in Europe. Acquisition of a priority review voucher to potentially accelerate FDA review of the SNDA for SHTG, potentially bringing the drug to market four months earlier. Robust pipeline progress, including positive interim data for ARO-INHBE in obesity/MASH, full enrollment of the Phase III Yosemite study for zodasiran, and upcoming data readouts for ARO-DiRPA and ARO-MAP-T. Strong balance sheet with approximately $1.6 billion in cash and investments, providing financial flexibility for ongoing development and commercialization. Partnership strategy yielding significant milestones, including a $25 million upfront payment from Madrigal for ARO-PNPLA-3, with potential for up to $975 million in milestones and royalties. Scalable commercial infrastructure designed to support future indications and multiple products, with plans to expand field force to address over 20,000 HCP targets for SHTG. Net loss widened to $194.3 million in the quarter, compared to $175.2 million in the prior year, driven by higher R&D and SG&A expenses. R&D expenses increased by $36 million year-over-year, reflecting continued high investment in clinical development and manufacturing. SG&A expenses rose to $47 million, up from $31 million, due to increased commercial headcount and launch support costs. The acquisition of the priority review voucher for $215 million represents a significant cash outlay, with the return dependent on successful approval and launch. Commercial revenue from Redemplo remains modest at approximately $2.4 million for the quarter, indicating early-stage launch revenue generation. The SHTG market launch is expected to be a slow ramp due to the need for extensive physician and patient education, potentially limiting near-term revenue growth. Uncertainty regarding ex-U.S. market revenue due to factors like MFN and varying reimbursement processes, which could impact international sales. The company is under embargo for detailed SHASTA-3/4 data until ESC, limiting transparency and potentially affecting investor confidence. The Phase III Yosemite study for zodasiran is not expected to complete until mid-2027, with data in the second half of 2027, delaying potential revenue from this program. The company faces competitive pressure in the SHTG market, with a competitor already launched, and the need to justify a premium price for Redemplo. Q: With the SHASTA-3 and SHASTA-4 data in hand, what are the gating factors for the sNDA submission by year-end 2026, and can you comment on any imbalances in liver fat, ALP elevations, or glycemic parameters?A: James Hamilton (CMO & Head of R&D) stated that the team is focused on generating sNDA modules and study reports to file by the end of the year, with a pre-sNDA meeting with the FDA planned. He declined to comment on specific safety data details, citing the embargo until the ESC presentation. Q: What top-line data will you share from the ARO-MAP-T Phase 1 study in September, and what level of target knockdown are you looking for?A: James Hamilton (CMO & Head of R&D) explained that the September readout will be from healthy volunteers, focusing on safety and total tau knockdown as the primary pharmacodynamic biomarker. He reiterated that the benchmark for success remains a 50% to 60% knockdown, a level that has shown clinical improvements in other studies. Q: How will you scale the sales force for the potential SHTG launch, and what is the sequencing over the next several months?A: Andy Davis (SVP & Head of Global Cardiometabolic Franchise) stated that the field force will expand from addressing over 5,000 HCP targets to over 20,000, including specialists and primary care physicians who act like specialists. The final onboarding and optimization of the field force is expected to be completed before the end of the year to prepare for a potential accelerated SHTG launch in Q2 2027. Q: What proportion of patients in SHASTA-3 and SHASTA-4 received an MRI to assess liver fat, and will you continue the SHASTA-5 trial?A: James Hamilton (CMO & Head of R&D) declined to provide details on the MRI subgroup, citing the embargo. He confirmed that there are no plans to terminate the SHASTA-5 study at this time, and it will continue to run without changes until the label is better understood. Q: Which triglyceride responder analysis is more important for establishing plozasiran's value, and will the priority review voucher allow for Part D coverage for most of 2027?A: James Hamilton (CMO & Head of R&D) noted that the 500 mg/dL threshold is key for reducing acute pancreatitis risk, while Chris Anzalone (CEO) added that both 150 and 500 mg/dL thresholds are important, as normalizing a large percentage of patients is an attractive goal. Andy Davis (SVP) stated that the market access team will interact with payers as soon as data is published to prepare for policy development and coverage throughout 2027. Q: How do you see the difference in prescribing between the U.S. and European markets for SHTG, and how much of the $3-4 billion peak sales estimate is U.S.-based?A: Chris Anzalone (CEO) stated that the overwhelming majority of the peak sales estimate is U.S.-based. Andy Davis (SVP) added that European markets are very outcomes-based, making the statistically significant reduction in acute pancreatitis events from the pooled analysis incredibly important for demonstrating value, though the MFN uncertainty makes it difficult to project ex-U.S. revenue. Q: With the Ionis launch underway, how should we think about the right analogs for the SHTG commercial opportunity, and how important are the initial quarters for validating the market size?A: Andy Davis (SVP) emphasized the importance of getting out of the gates quickly, focusing on educating providers and working with payers to accelerate the ramp. He noted a high degree of overlap between FCS and SHTG prescribers, which bodes well for the ramp. Chris Anzalone (CEO) added that SHTG is a large market opportunity, but the launch will be a relatively slow ramp as it is a brand-new market requiring significant education. Q: What is the current weekly prescription run rate for Redemplo, and has the prescription-to-drug conversion rate hit steady state?A: Andy Davis (SVP) confirmed the run rate is approximately 20-30 new prescriptions per week, consistent with prior disclosures. He noted that the market access team is working hard to navigate prior authorizations and appeals, and with new field personnel onboarding this month, he expects an inflection point in both prescriptions and the conversion funnel to patient shipments. Q: Will the SHTG launch be segmented to the highest-risk patients or broader across patients with TGs above 500, and how will this reflect on the commercial build?A: Andy Davis (SVP) stated that while the data supports Redemplo across the spectrum of SHTG patients, the initial focus will be on high-risk patients with the highest unmet need and payer willingness to pay. Chris Anzalone (CEO) added that the data shows it's important to lower triglycerides for anyone above 500 mg/dL, as pancreatitis events occurred in patients below 880 mg/dL, but the broader market will require time and education. Q: How are you thinking about price differential versus the competitor now that you have the SHASTA data?A: Andy Davis (SVP) declined to discuss pricing or contracting strategy but noted the $45,000 WAC is justified by the product's efficacy, safety, and convenience. Chris Anzalone (CEO) confirmed there are no plans to change the price, citing the better safety profile, greater TG reduction, quarterly dosing, lack of liver enzyme monitoring, and simple 25 mg dose as reasons for the premium. Q: What other CNS targets are you excited about if the ARO-MAP-T Phase 1 data is positive?A: James Hamilton (CMO & Head of R&D) stated that the company has many undisclosed targets in its preclinical pipeline. He noted that wholly owned programs will likely not be disclosed until around the time of CTA filing due to the competitive nature of the siRNA space. Q: What are the plans for marketing Redemplo in the newly approved geographies (U.S., Canada, Australia, Europe), and how will revenue be recognized?A: Andy Davis (SVP) explained that Arrowhead is marketing directly in those countries using commercial partners, with the exception of China, where San For the complete transcript of the earnings call, please refer to the full earnings call transcript.

- Conference Call and Webcast Today, August 4, 2026, at 4:30 p.m. ET PASADENA, Calif., August 04, 2026--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2026 third quarter ended June 30, 2026. The Company is hosting a conference call today, August 4, 2026, at 4:30 p.m. ET to discuss the results. "The recent period for Arrowhead included transformational events that support continued growth," said Christopher Anzalone, Ph.D., President and CEO at Arrowhead Pharmaceuticals. "We recently announced topline results from the SHASTA-3 and SHASTA-4 studies supporting our continued belief that plozasiran is a best-in-class molecule for patients with a spectrum of triglyceride disorders. Based on these promising results, we acquired a priority review voucher (PRV) that potentially accelerates the process of bringing this important new medicine to patients. On the commercial front, REDEMPLO continued to demonstrate growing momentum and penetration with physicians and patients with familial chylomicronemia syndrome. Lastly, we made strong progress across our broad pipeline of RNAi therapeutic candidates at various stages of development, expanding the opportunity to help patients in diverse disease areas." Key REDEMPLO® Commercial Events U.S. REDEMPLO launch continued to build momentum during the quarter. Key progress included: Announced marketing authorizations of REDEMPLO in two new territories: Key R&D Events Announced topline results for the global Phase 3 SHASTA-3 and SHASTA-4 clinical studies of plozasiran in patients with severe hypertriglyceridemia (sHTG). Detailed results will be presented as a HOT LINE Late Breaker at the European Society of Cardiology (ESC) Congress on August 30, 2026. Announced that the Company completed enrollment in the global Phase 3 YOSEMITE clinical trial of zodasiran, the Company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for homozygous familial hypercholesterolemia (HoFH), a rare genetic condition that leads to severely elevated low-density lipoprotein cholesterol (LDL-C) and early-onset cardiovascular disease. Presented interim results at the European Association for the Study of the Liver Congress (EASL 2026) from a Phase 1/2a clinical trial of ARO-INHBE, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for obesity and metabolic dysfunction-associated steatohepatitis (MASH). Reported new positive plozasiran clinical data in two oral presentations at the 94th European Atherosclerosis Society (EAS) Congress. The data support plozasiran use in patients with moderate-to-severe renal impairment or moderate hepatic impairment without the need for dose adjustment and suggests that preconception exposure to plozasiran may be associated with sustained lowering of fasting triglyceride levels through the term of a pregnancy. Key Corporate Events Acquired a U.S. Food and Drug Administration (FDA) priority review voucher, which the company intends to use with its upcoming plozasiran sNDA submission, anticipated before the end of 2026, to potentially expand the approved indication to include patients with severe hypertriglyceridemia (sHTG). Announced an exclusive worldwide license agreement with Madrigal Pharmaceuticals for ARO-PNPLA3, Arrowhead’s clinical stage RNAi therapeutic designed to reduce liver expression of patatin-like phospholipase domain containing 3 (PNPLA3) as a potential treatment for patients with metabolic dysfunction-associated steatohepatitis (MASH). Webcast and Conference Call and Details Investors may access a live audio webcast on the Events and Presentations page under the Investors section of the Arrowhead website. A replay of the webcast will be available approximately two hours after the conclusion of the call. For analysts that wish to participate in the conference call, please register at https://register-conf.media-server.com/register/BIe3d7a8269de14d348890ebe006a5b6a1. Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call. Selected Fiscal 2026 Third Quarter Financial Results About REDEMPLO® (plozasiran) REDEMPLO (plozasiran) is currently approved by the U.S. Food and Drug Administration, Health Canada, China’s National Medical Products Administration, the Australian Therapeutic Goods Administration, and by the European Commission as an adjunct to diet to reduce triglycerides for adults with FCS. REDEMPLO is the first and only siRNA treatment approved in these countries to be studied in both clinically diagnosed and genetically confirmed patients living with FCS. REDEMPLO is designed to suppress the production of apolipoprotein C-III (APOC3), a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting APOC3 with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is self-administered via subcutaneous injection once every three months. REDEMPLO has been granted Orphan Medicinal Product Designation by the EMA for the treatment of patients with FCS, and Breakthrough Therapy Designation, Fast Track Designation, and Orphan Drug Designation by the U.S. FDA for the treatment of patients with FCS and was also granted Breakthrough Therapy designation by the U.S. FDA in severe hypertriglyceridemia. Sanofi acquired the rights to develop and commercialize REDEMPLO in Greater China, with Arrowhead retaining rights to REDEMPLO in all geographies, outside of Greater China. For more information about REDEMPLO, visit Our Medicines. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals (NASDAQ: ARWR) is a commercial-stage pharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them, harnessing the natural RNA interference (RNAi) mechanism. The company has built a broad portfolio of clinical and commercial RNAi therapeutics through its industry-leading targeted RNAi molecule (TRiM™) platform, which can precisely silence genes in a wide range of cell types, including liver, lung, muscle, adipose, and central nervous system tissue. At Arrowhead, we rapidly advance potential best- and first-in-class RNAi treatments for diseases with significant unmet medical need, because every day matters to the patients we serve. For more information, please visit www.arrowheadpharma.com, or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts. Safe Harbor Statement under the Private Securities Litigation Reform Act: This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "hope," "intend," "plan," "project," "could," "estimate, "target," "forecast" or "continue" or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline, products or product candidate or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about our beliefs and expectations regarding the long-term impacts of REDEMPLO® (plozasiran) on patient health and the health care system; our beliefs and expectations regarding the pricing, value, or expected timing of regulatory approval and the availability of our drugs and drug candidates, including but not limited to plozasiran; and our beliefs and expectations around the potential uses and value of the TRiM™ platform. These statements are based upon our current expectations and speak only as of the date hereof. Actual results or outcomes may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties including the safety and efficacy of our products and product candidates, pricing and reimbursement decisions related to our products, demand for our products, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances. Source: Arrowhead Pharmaceuticals, Inc. View source version on businesswire.com: https://www.businesswire.com/news/home/20260804998802/en/ Contacts Arrowhead Pharmaceuticals, Inc.Vince Anzalone, [email protected] Investors: LifeSci Advisors, LLCBrian Ritchie [email protected] Media: LifeSci Communications, LLCKendy Guarinoni, [email protected]

Interested in Arrowhead Pharmaceuticals, Inc.? Here are five stocks we like better. Plozasiran delivered positive Phase III results in severe hypertriglyceridemia, reducing triglycerides by 79% to 81% and cutting acute pancreatitis events by 78% in a pooled analysis. Arrowhead plans to submit a supplemental FDA application before the end of 2026 and may use a priority review voucher to shorten the review period. REDEMPLO’s commercial launch is gaining momentum in familial chylomicronemia syndrome, with prescription volume more than doubling, over 400 prescribers supported and quarterly revenue reaching approximately $2.4 million. The company expects broader payer coverage and additional sales personnel to support growth. Arrowhead’s third-quarter revenue increased to approximately $75 million, but its net loss widened to $194.3 million as operating expenses rose. The company ended the quarter with about $1.6 billion in cash and investments, supporting continued pipeline development and commercialization efforts. Want Diversified Upside in Biotechnology? Check out LABU Arrowhead Pharmaceuticals (NASDAQ:ARWR) reported positive Phase III results for plozasiran in severe hypertriglyceridemia (SHTG), accelerating plans for a supplemental New Drug Application and highlighting continued growth in the launch of its REDEMPLO therapy for familial chylomicronemia syndrome (FCS). For the fiscal third quarter ended June 30, 2026, Arrowhead recorded a net loss of $194.3 million, or $1.36 per diluted share, compared with a loss of $175.2 million, or $1.26 per share, a year earlier. Revenue rose to approximately $75 million from $28 million in the prior-year period, driven by collaboration agreements and commercial REDEMPLO sales. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control President and Chief Executive Officer Dr. Chris Anzalone said the company’s Phase III SHASTA-3 and SHASTA-4 studies both met their primary endpoint and all prespecified secondary endpoints in patients with SHTG. Median triglyceride reductions from baseline were 79% in SHASTA-3 and 81% in SHASTA-4. In the studies’ placebo groups, reductions were approximately 27%, according to Andy Davis, senior vice president and head of the Global Cardiometabolic Franchise. → Financials Hit Record Highs as the AI Trade Unravels—Can They Keep Leading? Arrowhead also reported a statistically significant reduction in acute pancreatitis events in a prespecified pooled analysis of the trials. Davis said plozasiran reduced cumulative acute pancreatitis events by 78% versus placebo across the broader SHTG population. In a subgroup of patients with triglyceride levels above 880 milligrams per deciliter and a prior history of acute pancreatitis, the company reported a 100% reduction in events versus placebo. The company said safety and tolerability findings were consistent with prior plozasiran studies. Anzalone said Arrowhead observed no new safety signals, no clinically meaningful adverse changes in liver enzymes, no hypersensitivity cases and no thrombocytopenia signal. In a prespecified MRI-PDFF subgroup, there was no statistically significant difference in mean liver fat content between plozasiran and placebo. → Why Rare Earth Processing Could Be the Real 2027 Opportunity Detailed SHASTA results are scheduled for presentation at the European Society of Cardiology Congress on Aug. 30, followed by an Arrowhead webcast on Aug. 31. Chief Medical Officer and Head of R&D Dr. James Hamilton said the company remained under embargo regarding further trial details ahead of the conference. Arrowhead intends to submit an sNDA to the Food and Drug Administration before the end of 2026. The company acquired an FDA priority review voucher that could shorten the agency’s review period from 10 months to six months. Chief Financial Officer Dan Apel said Arrowhead expects to pay $215 million for the voucher during its fiscal fourth quarter, following Hart-Scott-Rodino clearance. Management said the initial focus of a potential SHTG launch would likely be patients at the highest risk, while emphasizing that the clinical data support treatment across patients with triglyceride levels above 500 milligrams per deciliter. Anzalone said the company expects SHTG to be an education-driven market because physicians have historically had limited options for substantially reducing triglycerides. REDEMPLO prescription volume more than doubled during the fiscal third quarter and that momentum continued into the current quarter, Davis said. Arrowhead has supported more than 400 unique prescribers, led by preventive cardiologists and endocrinologists. Davis said the company was receiving approximately 20 to 30 new prescriptions per week, consistent with its previously disclosed run rate. Arrowhead is working to improve the progression of prescriptions through prior authorization and appeals processes and expects an additional wave of field personnel to enter the market during August. REDEMPLO has favorable policies in place with the most significant U.S. payers, according to Davis, and the company expects remaining coverage gaps to narrow in the coming months. Nearly all published payer policies allow clinicians to diagnose FCS through clinical criteria rather than genetic confirmation alone. The therapy’s U.S. wholesale acquisition cost remains $45,000 per patient annually. Management said it does not intend to change the price following the SHASTA results, citing REDEMPLO’s efficacy, safety profile, quarterly dosing schedule and 25-milligram fixed dose. REDEMPLO is approved for FCS in the United States, Canada, China, Australia and the European Union. Arrowhead said reimbursement processes in Europe will proceed country by country over approximately 12 months, beginning with Germany. Sanofi leads commercialization in Greater China. Arrowhead expects several clinical data releases before year-end. The company plans to report top-line Phase I data for ARO-DIMER-PA in September. The candidate is designed to silence both APOC3 and PCSK9 to reduce LDL cholesterol and triglycerides in patients with mixed hyperlipidemia. The company also expects September data from its Phase I healthy-volunteer study of ARO-MAPT, a subcutaneously administered RNA interference therapy targeting tau. Hamilton said the release will focus on safety and total tau knockdown, with Arrowhead targeting approximately 50% to 60% knockdown. The study’s second phase in Alzheimer’s disease patients is actively enrolling. For obesity and metabolic dysfunction-associated steatohepatitis, Arrowhead plans to provide an update primarily focused on ARO-ALK7 in the fourth quarter. It has submitted an ARO-INHBE Phase IIb protocol to regulators. Earlier data showed a placebo-adjusted 44% reduction in liver fat in a small subgroup of patients with obesity and elevated baseline liver fat receiving at least a 200-milligram dose as monotherapy. Separately, Arrowhead completed enrollment in the Phase III YOSEMITE trial of its therapy for homozygous familial hypercholesterolemia, enrolling 70 patients compared with a planned 60. The company expects study completion in mid-2027 and data in the second half of 2027. Apel said the quarter’s revenue included approximately $26 million from the Sarepta collaboration, about $20 million from the Novartis collaboration and the full $25 million upfront payment from Madrigal for the ARO-PNPLA3 license and technology transfer. Commercial REDEMPLO revenue was approximately $2.4 million for the quarter, more than double the roughly $1 million reported in the prior fiscal quarter. Arrowhead said it does not plan to separately highlight product sales until they become a more meaningful financial contributor. Operating expenses increased to approximately $245 million from $193 million a year earlier, including research and development expense of $198 million and selling, general and administrative expense of $47 million. The increases reflected clinical development, manufacturing activity and commercialization investment. Arrowhead ended the quarter with approximately $1.6 billion in cash and investments. Apel said the company believes its balance sheet provides flexibility to fund pipeline development, commercial activities and longer-term strategic priorities. Arrowhead Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of RNA interference (RNAi) therapeutics. Since its founding in 2008, Arrowhead has leveraged its proprietary delivery platform—known internally as the Advanced RNAi Compound (ARC) technology—to silence disease-causing genes in patients suffering from genetically defined diseases. The company's approach aims to offer durable, targeted treatments across a range of therapeutic areas. The company's pipeline includes multiple candidates in various stages of development. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Arrowhead Pharmaceuticals Q3 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

PASADENA, Calif., July 21, 2026--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it will host a webcast and conference call on August 4, 2026, at 4:30 p.m. ET to discuss its financial results for the fiscal 2026 third quarter ended June 30, 2026. Webcast and Conference Call Details Investors may access a live audio webcast on the Events and Presentations page under the Investors section of the Arrowhead website. A replay of the webcast will be available approximately two hours after the conclusion of the call. For analysts that wish to participate in the conference call, please register at https://register-conf.media-server.com/register/BIe3d7a8269de14d348890ebe006a5b6a1. Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals (NASDAQ: ARWR) is a commercial-stage pharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them, harnessing the natural RNA interference (RNAi) mechanism. The company has built a broad portfolio of clinical and commercial RNAi therapeutics through its industry-leading targeted RNAi molecule (TRiM™) platform, which can precisely silence genes in a wide range of cell types, including liver, lung, muscle, adipose, and central nervous system tissue. At Arrowhead, we rapidly advance potential best- and first-in-class RNAi treatments for diseases with significant unmet medical need, because every day matters to the patients we serve. For more information, please visit www.arrowheadpharma.com, or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts. Safe Harbor Statement under the Private Securities Litigation Reform Act: This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "hope," "intend," "plan," "project," "could," "estimate," "continue," "target," "forecast" or "continue" or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances. Source: Arrowhead Pharmaceuticals, Inc. View source version on businesswire.com: https://www.businesswire.com/news/home/20260721983600/en/ Contacts Arrowhead Pharmaceuticals, Inc.Vince Anzalone, [email protected] Investors:LifeSci Advisors, LLCBrian [email protected] Media:LifeSci Communications, LLCKendy Guarinoni, [email protected]

Interested in Arrowhead Pharmaceuticals, Inc.? Here are five stocks we like better. REDEMPLO launch shows early commercial momentum with about 30 new prescriptions per week (over 400 total), accelerating refills and ~10% switches from a competitor, while Arrowhead set U.S. WAC at $45,000 to support market access and anticipated SHTG expansion. Several near-term clinical catalysts are expected in 2026, notably top-line Phase III results for plozasiran (SHASTA-3/4) in Q3 with pooled pancreatitis analyses, early Phase I/II ARO‑DIMER‑PA biomarker data in Q3, and an initial ARO‑MAPT readout around end‑Q3/early‑Q4. Financially Arrowhead reported a Q2 net loss of $132.7M but has a strong balance sheet with nearly $1.8 billion in cash and investments after >$1B raised in recent financings; revenue was $74M (including collaboration payments) and the company signed a license with Madrigal for ARO‑PNPLA3 with $25M upfront and up to $975M in milestones. Want Diversified Upside in Biotechnology? Check out LABU Arrowhead Pharmaceuticals (NASDAQ:ARWR) highlighted continued commercial traction for REDEMPLO and outlined multiple anticipated clinical catalysts in the second half of 2026 as the company reported fiscal 2026 second-quarter results for the period ended March 31, 2026. President and CEO Dr. Chris Anzalone said the company is “now on the strongest footing of our history,” pointing to an expanding commercial footprint, a broader pipeline, and a stronger balance sheet. → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? REDEMPLO was approved by the FDA in November 2025 as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). Anzalone described FCS as a severe rare disease that can carry a substantially increased risk of acute pancreatitis. Management said the U.S. launch continues to build on an initially strong start. Anzalone said the company is seeing “around 30 new prescriptions written each week,” with “more than 400 prescriptions” written since launch. He added that “more than 10%” of prescriptions have been for patients switching from a competing APOC3 inhibitor. Senior Vice President and Head of the Global Cardiometabolic Franchise Andy Davis said prescriptions accelerated through the fiscal second quarter, “growing nearly threefold from the start to the end of the quarter,” and noted that total prescriptions written exceeded 400. → A Prada Payday: Is AMC Back in Style? Davis also described early indicators of persistence, saying refill activity is “accelerating meaningfully,” which he characterized as an early validation of clinical effectiveness, patient satisfaction, and REDEMPLO’s once-quarterly dosing profile. He said the geographic distribution of prescribing has been balanced across the U.S., signaling broad territory activation rather than reliance on a small number of high-volume centers. On patient mix, Davis said approximately 85% of prescriptions are from patients naïve to the APOC3 class, with the remainder largely switch patients. Asked about motivations for switching, Davis said the company has seen “diversity of reasons” including efficacy, safety, and tolerability. → Insider Sales: Top AST SpaceMobile Insider Cuts Postion Over 30% Management also discussed a change in wholesale acquisition cost (WAC). Anzalone said Arrowhead updated REDEMPLO’s U.S. WAC to $45,000 per patient per year and described it as a premium to a competitor’s WAC, which he said the company believes is appropriate based on clinical data suggesting superior triglyceride reduction, safety profile, and convenience. Davis framed the $45,000 price as part of a strategy to optimize market access and reduce friction in formulary decisions and prior authorization. In Q&A, CFO Daniel Apel said Arrowhead is not providing guidance on gross-to-net at this stage and said the company had not seen anything substantial in that regard beyond statutory items such as Medicaid rebates. Anzalone emphasized the WAC reduction “had nothing to do with any pushback from payers,” describing payer interactions as “quite positive,” and said the company made the move in expectation of a future severe hypertriglyceridemia (SHTG) market expansion and to reduce the likelihood of payers requiring a “step through” a competitor. Davis said Arrowhead’s market access team has been engaged with large U.S. payers and that discussions are proceeding as expected, with some resulting in improved coverage and additional formulary decisions expected in coming months across commercial and government segments. He pointed to what he called an important trend: “diagnostic pathway flexibility” in payer coverage policies. Davis said policies taking shape recognize both genetic testing and clinical criteria as valid routes to diagnosis, which he said is important because a meaningful proportion of real-world FCS patients are clinically diagnosed rather than genetically confirmed. Anzalone said Arrowhead secured positive regulatory action in four additional geographies for REDEMPLO in FCS, citing approvals from Australia’s Therapeutic Goods Administration, China’s National Medical Products Administration, and Health Canada, as well as a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Davis said Canada and China approvals came in January, with Australia following “last month,” and that all three markets are in pre-launch phases as Arrowhead works through pricing and reimbursement. In Europe, he said CHMP recommended EU marketing authorization for REDEMPLO in FCS “without requiring genetic confirmation,” and he anticipated an EMA decision in the June to July timeframe. Davis said Arrowhead intends to commercialize directly in Europe using contracted infrastructure spanning market access, account management, medical affairs support, and stakeholder engagement. Anzalone said REDEMPLO will be marketed by Sanofi in Greater China, while Arrowhead anticipates marketing independently in Canada. Pending a European Commission decision, he said the company expects launches later this year in select EU countries and “likely in the U.K. as well.” Arrowhead leaders highlighted several expected clinical readouts in 2026. Plozasiran in SHTG (SHASTA-3/4 and supporting studies): Anzalone and Davis said top-line results from registrational Phase III studies SHASTA-3 and SHASTA-4 are expected in Q3, with Anzalone also referencing SHASTA-3 and “four studies” in SHTG and Davis describing SHASTA-3 and SHASTA-4 as the two registrational studies. Chief Medical Officer Dr. James Hamilton said SHASTA-3 and SHASTA-4 enrolled over 750 patients and have a primary endpoint of triglyceride change from baseline and key secondary endpoints of acute pancreatitis (AP) rates. Hamilton added that MUIR-3 enrolled over 1,400 patients to provide additional safety data and that SHASTA-5 is enrolling high-risk patients with AP risk reduction as a primary endpoint. He said the blinded portion of SHASTA-3, SHASTA-4, and MUIR-3 is expected to complete in mid-2026, supporting a planned top-line readout in Q3. Analysis of pancreatitis endpoints: In response to an analyst question, Hamilton said the plan is to pool SHASTA-3 and SHASTA-4 and conduct a meta-analysis of AP event rates, including both event rates in individual patients and total events. He said the studies remain blinded ahead of the expected Q3 data. Asked whether Arrowhead might extend the blinded period to accrue additional AP events, Hamilton said the company feels “comfortable with the number of events” seen so far and said there are “no plans to extend the study or stay blinded for a longer period at this time.” Hamilton also noted that SHASTA-2 used strict Atlanta criteria for pancreatitis events, while SHASTA-3/4 pooled analysis uses “modified Atlanta criteria” including definite, probable, and possible pancreatitis. ARO-DIMER-PA in mixed hyperlipidemia: Anzalone and Hamilton said early data from the Phase I/II study of ARO-DIMER-PA is expected in Q3. Hamilton described ARO-DIMER-PA as the first dual-functional siRNA intended to silence two genes—PCSK9 and APOC3—with a single molecule. He said the study initiated in January and is designed as a placebo-controlled, dose-escalating trial evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on LDL cholesterol and triglycerides, with up to 78 adults enrolled across single-dose and multiple-dose parts. Hamilton said enrollment has been rapid and that the company expects sufficient data for a first clinical readout in Q3. In Q&A, he said the program’s relevant biomarkers are blood-based and that the initial readout will focus on biomarker effects and safety, with development plans to be shared later. ARO-MAPT for tauopathies via a CNS platform: Management expects an initial ARO-MAPT readout around the end of Q3 or early Q4. Hamilton said the first subjects were dosed in December 2025 in a Phase I/II placebo-controlled, dose-escalating study in up to 64 healthy subjects and up to 48 patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s dementia. He said the study is nearing completion of enrollment for the single-dose healthy-volunteer portion and has begun multi-dose cohorts in both healthy volunteers and Alzheimer’s patients. Separately, Hamilton highlighted long-term plozasiran data presented at the American College of Cardiology meeting in March from a two-year open-label extension of Phase IIb studies. He said median triglyceride reductions were 83% in SHTG patients from SHASTA-2 and 67% in hypertriglyceridemia patients from MUIR, and that no adjudicated acute pancreatitis events occurred in patients receiving plozasiran during the two-year extension. CFO Daniel Apel reported a net loss of $132.7 million, or $0.93 per share, for the quarter ended March 31, 2026, compared with net income of $370.4 million, or $2.75 per share, in the year-ago quarter. Apel attributed the prior-year period’s income to “over $540 million in revenue solely related to the Sarepta transaction” executed at that time. Revenue for the quarter totaled $74 million, driven primarily by licensed and collaboration agreements with Sarepta and Novartis. Apel said approximately $42 million was related to the Sarepta collaboration, including $28 million from ongoing recognition of initial Sarepta consideration, $10 million of reimbursement for preclinical collaboration costs, and $4 million for clinical supply. He also said Arrowhead recognized $20 million of a $200 million upfront payment from Novartis received in October, bringing year-to-date recognition of that upfront to $54 million, with $146 million remaining to be deferred over time as preclinical obligations are fulfilled. Apel said Arrowhead recorded $11 million related to the Sanofi-Visirna asset purchase agreement in Greater China, which he said was “almost entirely due” to China’s January approval for FCS. Apel said Arrowhead is not yet highlighting specific REDEMPLO product sales numbers, but noted net sales can be derived as the difference between total net revenue and collaboration revenue, representing approximately $1 million for the quarter. He said this was the first full quarter of REDEMPLO sales and compared favorably on a unit basis to the first full commercial quarter of the other approved APOC3 inhibitor. Total operating expenses were approximately $215 million, roughly flat sequentially and up from $162 million a year ago. Apel said the year-over-year increase was driven by $40 million higher R&D expense and $13 million higher SG&A, aligning with expectations. He said nearly two-thirds of year-to-date clinical trial spend was attributable to plozasiran Phase III studies and expected spending for those programs to moderate after summer readouts. Arrowhead ended the quarter with nearly $1.8 billion in cash and investments. Apel said the company brought in over $1 billion during the quarter, including approximately $850 million net from January financing transactions consisting of concurrent offerings of $700 million of 0% coupon convertible senior notes and $230 million of common stock, along with an associated capped call transaction. He also cited a $200 million Sarepta milestone payment and a $50 million anniversary payment under the Sarepta long-term collaboration. In addition, Anzalone discussed an exclusive worldwide license agreement with Madrigal Pharmaceuticals for ARO-PNPLA3, a clinical-stage program aimed at a genetically defined population of MASH patients. Under the agreement, he said Madrigal will pay a $25 million upfront payment and Arrowhead is eligible for up to $975 million in development, regulatory, and sales milestones, plus tiered royalties up to the mid-teens. In Q&A, Anzalone said the program originated from Arrowhead’s deal with Janssen, that Janssen conducted the Phase I, and that the asset was returned when Janssen exited MASH. He said Arrowhead did not spend money on the program and viewed Madrigal as a “pure play MASH company” suited to develop a genetically defined approach that may require a companion diagnostic. Arrowhead Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of RNA interference (RNAi) therapeutics. Since its founding in 2008, Arrowhead has leveraged its proprietary delivery platform—known internally as the Advanced RNAi Compound (ARC) technology—to silence disease-causing genes in patients suffering from genetically defined diseases. The company's approach aims to offer durable, targeted treatments across a range of therapeutic areas. The company's pipeline includes multiple candidates in various stages of development. The article "Arrowhead Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Image source: The Motley Fool. Thursday, May 7, 2026 at 4:30 p.m. ET Chief Executive Officer — Dr. Christopher Anzalone Chief Commercial Officer — Andy Davis Chief Medical Officer — Dr. James M. Hamilton Chief Financial Officer — Daniel Apel Need a quote from a Motley Fool analyst? Email [email protected] Dr. Christopher Anzalone: Thanks, Vince. Good afternoon, everyone, and thank you for joining us today. During the fiscal second quarter and the period since our last earnings call, we have continued to execute well against our commercial, R&D and corporate goals. Arrowhead is now on the strongest footing of our history. We are commercial. We have a clear line of sight to expand our commercial opportunities and footprint. Our pipeline is larger than ever. Our discovery capabilities are broader than ever, and our balance sheet is stronger than ever. This is a historic time for our company. We are uniquely positioned to deliver important medicines to patients who need them and to create substantial value for our shareholders. Let's talk about some of our recent progress and begin with commercial. As you recall, the FDA approved REDEMPLO in November 2025 as an adjunct to diet to reduce triglycerides in adults with FCS. FCS is a severe rare disease with an estimated 6,500 people in the U.S. living with genetic or clinical FCS, characterized by TG levels that can be 10 to 100x higher than normal. This leads to a substantially increased risk of developing acute, recurrent and potentially fatal pancreatitis. As we reported last quarter, the U.S. REDEMPLO launch was off to a strong start. That momentum has continued into the current quarter and we are now seeing around 30 new prescriptions written each week. Greater than 400 prescriptions have been written since launch and more than 10% of these have been for patients switching from our competitors' APOC3 inhibitor. Of course, each prescription needs to be fully adjudicated with payers before becoming paid claims, but we offer a robust quick start program to support these FCS patients in the interim. The volume of physicians writing prescriptions and the number of patients receiving REDEMPLO continues to exceed our initial expectations. With respect to pricing, we updated REDEMPLO's U.S. wholesale acquisition cost or WAC to $45,000 per patient per year. This represents a premium to our competitor's WAC pricing. We believe this is appropriate given that clinical data suggests we have a clearly and demonstrably superior product in terms of TG reduction, safety profile and convenience. As part of the One REDEMPLO unified pricing model, this price is intended to remain consistent across FCS and SHTG if that indication is approved. We continue to see this strategy as potentially simplifying payer contracting and eliminating pricing complexity that could complicate future formulary negotiations. Response from payers to this strategy has been positive and our interactions to date have been productive. Beyond the U.S., we secured positive regulatory action in 4 additional geographies for REDEMPLO in patients with genetically confirmed and clinically defined FCS. We received approvals from the Australian Therapeutic Goods Administration, the Chinese National Medical Products Administration and Health Canada. In addition, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the approval of REDEMPLO. This is an impressive result achieved by our global regulatory team in a very short period and further reflects the strength of our clinical data in FCS and the value that REDEMPLO offers to patients. REDEMPLO will be available later this year in Canada, and we anticipate it will be marketed independently by Arrowhead. Pending a marketing authorization decision from the European Commission, we expect to launch REDEMPLO later this year in select EU countries and likely in the U.K. as well. In Greater China, REDEMPLO will be marketed by Sanofi. In addition to our regulatory team, the rest of the R&D organization has performed extremely well and has made progress in the broader portfolio. Our drive to expand our platforms in order to increase the number and types of diseases we can address continues even as we grow as a commercial entity. During the recent period, we have made rapid progress across the pipeline, including programs targeting genes expressed in liver, skeletal muscle, adipose, CNS and the lung as well as the first dual functional siRNA designed to silence the expression of 2 genes with a single molecule. We believe the depth and breadth of our clinical pipeline is unmatched and we expect to continue to lead the field in innovation. Importantly, many of these programs will have clinical readouts this year, so investors and others may start to properly value the broader pipeline. As we look to near-term clinical data releases, we anticipate 4 important events. First, the Phase III SHASTA-3 and -4 studies of plozasiran in SHTG patients should be ready for top line data release in Q3. This is an important readout that will drive our anticipated supplemental NDA or sNDA as we seek to expand the population of patients we can treat with plozasiran. We expect to continue to see a favorable safety profile and substantial reduction in TGs and we are cautiously optimistic that we could see an improvement in acute pancreatitis risk. Second, we expect to have early data from the ongoing Phase I/II study of ARO-DIMER-PA in patients with mixed hyperlipidemia in Q3. We believe this will be the world's first clinical data of a single RNAi molecule designed to simultaneously silence the expression of 2 proteins. If we see good reduction of PCSK9 and APOC3 and therefore, reductions in LDL-cholesterol NTTs, we could have a very powerful and unique therapy for roughly 20 million people in the U.S. living with mixed hyperlipidemia. More broadly, the data could provide initial clinical proof of concept for our growing dimer platform and pipeline. We expect to see additional dual functional dimers in the clinic in 2027. Third, we expect to have early data from the ongoing Phase I/II study of ARO-MAPT around the end of Q3 or early Q4. As you recall, this is our first candidate using our CNS platform designed to deliver RNAi molecules to the brain via simple subcutaneous administration. Our MAPT targets -- sorry, ARO-MAPT targets the tau protein, which is increasingly validated for the potential treatment of Alzheimer's and other tauopathies. We believe that positive early data could be substantially disruptive. It could represent a great move forward in treating tauopathies and more broadly open the door to using RNAi to treat a broad range of conditions from neurodegenerative disorders to obesity. The early ARO-MAPT data are encouraging. We expect a substantial expansion of our CNS pipeline beginning at the end of 2026. Fourth, we expect to provide clinical updates on ARO-INHBE and ARO-ALK7 throughout the second half of the year. Regarding ARO-INHBE, we plan to present additional data at various conferences and launch a Phase II study. For ARO-ALK7, we expect to provide additional data from the ongoing Phase I/II study. We see these as potentially important therapies for metabolic disorders and represent our first steps into obesity and NASH. We expect to have additional candidates in this space by the end of the year and into 2027. Moving on to financial and portfolio management. Arrowhead took important steps to ensure that we are properly funded to advance our commercial and development portfolio. We also entered into a license agreement for a program that achieved clinical proof of concept, but it's not one that we wish to take forward. This is key to Arrowhead's strategy since we are extraordinarily productive in discovery and early development but cannot commercialize everything independently. Let's talk about the steps we took. First, we dramatically strengthened our balance sheet, allowing us to push multiple programs toward commercialization and potentially through multiple independent and partner launches. During the quarter, we completed the largest fundraising Arrowhead has ever conducted. We closed concurrent public offerings of $700 million of 0% coupon convertible senior notes and $230 million of common stock. Both offerings were several times oversubscribed, reflecting investor confidence in our portfolio and our ability to continue to build value. Second, and just this week, we announced an exclusive worldwide license agreement with Madrigal Pharmaceuticals for ARO-PNPLA3, Arrowhead's clinical stage program designed to treat a genetically defined population of NASH patients. Under the terms of the agreement, Madrigal will pay a $25 million upfront payment to Arrowhead. Arrowhead is also eligible to receive development, regulatory and sales milestone payments of up to $975 million. Arrowhead is further eligible to receive tier royalties up to mid-teens. Madrigal's leadership in the NASH space makes it a natural and attractive partner to advance ARO-PNPLA3 into Phase II studies and towards potential commercialization. The transaction with Madrigal underscores Arrowhead's disciplined business development strategy, demonstrating our ability to partner high potential clinically validated programs with leading organization. With that overview, I'd now like to turn the call over to Andy Davis. Andy? Andy Davis: Thank you, Chris, and good afternoon, everyone. It has now been approximately 5.5 months since the FDA approval of REDEMPLO on November 18, 2025, and we continue to be very pleased with the trajectory of the launch. Today, I would like to cover 5 areas: prescription and patient dynamics, payer coverage development, pricing strategy, commercial infrastructure expansion and our international and SHTG outlook. Let's start with prescription and patient dynamics. REDEMPLO's launch continues to build strong and consistent momentum. Through the fiscal second quarter ending March 31, 2026, we have seen prescriptions accelerating week-over-week, growing nearly threefold from the start to the end of the quarter. That momentum has continued into the current quarter with total prescriptions written exceeding 400, representing over 40% growth over just the last 4 weeks alone. The awareness and conviction driving this prescription growth are encouraging. REDEMPLO awareness among the prescribers who matter most has increased meaningfully. Critically, this awareness has translated into conviction. Nearly all REDEMPLO prescribers surveyed report being satisfied or highly satisfied with the product, and REDEMPLO is perceived strongest on the efficacy outcomes SCS patients care about most, triglyceride reduction and acute pancreatitis risk reduction. The patient mix continues to reflect what we expected. Approximately 85% of prescriptions are from patients naive to the APOC3 class, a strong signal that physicians are identifying and treating FCS patients who have never had access to an effective therapy. Switch patients largely account for the remainder. Patient persistence data is equally encouraging. We feel activity is accelerating meaningfully, an important early validation of both clinical effectiveness and patient satisfaction for REDEMPLO's once quarterly dosing profile. Geographic distribution of prescribing is balanced across the country. This breadth of prescriber activation across all territories signals that patient identification capability is building at scale across the organization, not just concentrated in a handful of high-volume centers, and this gives us confidence in the durability of the prescription growth trajectory. Turning to payer access. We are making meaningful and consistent progress. Our market access team has been actively engaged with the largest payers in the country, covering the vast majority of U.S. lives to support continued patient access. These discussions are proceeding as expected and in some cases, have already led to REDEMPLO's improved coverage. Additional formulary coverage decisions are expected in the coming months across both commercial and government segments. A particularly important development in the payer landscape is the diagnostic pathway flexibility that major payers are recognizing. The coverage policies taking shape across major payers reflect both genetic testing and clinical criteria as valid routes to diagnosis. This is critical for ensuring that all appropriate REDEMPLO patients can access treatment because a meaningful proportion of real-world SCS patients are clinically diagnosed rather than genetically confirmed and policies that require genetic confirmation as a prerequisite would create an unnecessary and inappropriate barrier. As Chris mentioned, we have made a proactive decision to reduce the list price of REDEMPLO to $45,000 per patient per year. This decision reflects our commitment to optimizing market access for FCS patients and is consistent with our belief that a competitive and rational price point accelerates formulary decisions and reduces friction in the prior authorization process. We have always believed that REDEMPLO's clinical profile is best-in-class and the $45,000 per year price point reflects the premium value supported by the clinical evidence. With the FCS launch performing ahead of our expectations and with potential expansion into SHTG on the horizon, we are making deliberate and sequenced investments to scale our commercial infrastructure. I will speak more on this in the future, but the field infrastructure we are building will be sized and structured for both the current expanded FCS accessible population and also the future SHTG opportunity as it unfolds in the future. On international expansion, REDEMPLO received regulatory approval in both Canada and China in January and most recently in Australia last month. All 3 markets are currently in prelaunch phase as we work through the pricing and reimbursement frameworks in each country. We look forward to providing updates on those time lines as they develop. Also last month, CHMP, the Committee for Medicinal Products for Human Use, recommended EU marketing authorization for REDEMPLO in Europe for FCS without requiring genetic confirmation. Consequently, we anticipate an EMA approval decision in the June to July time frame. We intend to commercialize REDEMPLO directly in Europe, supported by contracted infrastructure, which encompasses market access strategy, account management deployment, medical science liaison support and broader stakeholder engagements, including medical congresses and patient advocacy group engagement. We believe this model is the right approach for Arrowhead and are pleased with the readiness of that team as we approach the anticipated EMA decision. Finally, I want to comment on the SHTG program, which represents the most significant near-term value catalyst for the cardiometabolic franchise. We are approaching what we expect to be a highly meaningful series of milestones. Top line results from SHASTA-3 and SHASTA-4, our 2 registrational Phase III studies in severe hypertriglyceridemia are expected in Q3. We head into the data readout with confidence grounded in the strength of REDEMPLO's established mechanism of action and the consistency of the APOC3 biology we have observed across our full clinical program to date. We also intend to present the data at a major medical congress, which we hope will be with a simultaneous publication in a top-tier medical journal. We then expect to file an sNDA with the FDA before the end of 2026 with an anticipated regulatory approval based on an expected standard review time line targeted in second half of 2027. Additional regulatory filings in other jurisdictions are planned to follow thereafter. The SHTG opportunity represents a patient population that is substantially larger than FCS with over 1 million high-risk patients in the United States alone. The commercial infrastructure investments we are making for FCS today are also designed with that launch in mind. In summary, the REDEMPLO launch is progressing well and continues to exceed our expectations across prescription volume, patient dynamics and payer access. Physician satisfaction and forward prescribing intent are both extremely strong. Refill activity is accelerating and we have a series of highly anticipated milestones in the second half of 2026 that we believe will be transformative for the cardiometabolic franchise and for Arrowhead. With that, I'll turn the call over to James Hamilton to discuss the broader R&D portfolio. James Hamilton: Thank you, Andy. As Chris mentioned, we have a very broad pipeline with over 20 clinical programs, so I will focus on areas with upcoming readouts. First, I'd like to announce that we are planning to host 3 webcasts over the coming months as part of our R&D webinar summer series. Each webcast will cover a specific aspect of our pipeline where we expect to have upcoming data readouts this year. These include cardiometabolic, including plozasiran, zodasiran and ARO-DIMER-PA, obesity, including ARO-INHBE and ARO-ALK7; and ARO-MAPT, including the blood-brain barrier or BBB platform. I'll now give status updates from the quarter on these specific areas. First, let's review the suite of plozasiran Phase III studies, SHASTA-3, SHASTA-4, SHASTA-5 and MUIR-3, designed to support supplemental NDA filings to expand the REDEMPLO label beyond genetic and clinical FCS into patients with SHTG. SHASTA-3 and SHASTA-4 together enrolled over 750 patients and have a primary endpoint of change in triglycerides from baseline with key secondary endpoints of acute pancreatitis rates. MUIR-3, which enrolled over 1,400 patients is designed to supplement the SHASTA studies with additional patient safety data. We are also enrolling patients at high risk of acute pancreatitis into SHASTA-5 to directly assess the ability of plozasiran to reduce the risk of acute pancreatitis as the primary endpoint. Should SHASTA-3 and SHASTA-4 show a statistically significant improvement in acute pancreatitis risk, we will reassess whether there is added value in continuing SHASTA-5. We remain on schedule to complete the blinded portion of the SHASTA-3, SHASTA-4 and MUIR-3 in mid-2026 to support a planned top line data readout in the third quarter. This would further support our plans for an sNDA submission for SHTG before the end of this year. Before moving on to zodasiran, I'd like to highlight a presentation we made with new long-term efficacy and safety data for plozasiran across a spectrum of patients with hypertriglyceridemia at the American College of Cardiology Conference in March. The data were from a 2-year open-label extension of the 2 Phase IIb double-blind placebo-controlled studies of plozasiran. SHASTA-2 conducted in adults with severe hypertriglyceridemia and MUIR, which enrolled patients with hypertriglyceridemia. During the 2-year open-label extension, patients saw median reductions in their triglycerides of 83% in SHTG patients from SHASTA-2 and 67% in HTG patients from MUIR with additional reductions in random and non-HDL cholesterol. 96% of SHTG patients achieved TGs below 500 milligrams per deciliter and 63% achieved TGs below 150 milligrams per deciliter with 93% of HTG patients achieving TGs below 150 milligrams per deciliter. Importantly, no adjudicated acute pancreatitis events occurred in any patient receiving plozasiran during the 2-year Phase IIb open-label extension study. These findings support the potential of plozasiran as a promising new approach to managing patients with moderate to severe HTG phenotypes who are at risk of AP and potentially other cardiometabolic comorbidities. I'd now like to give a quick update on the YOSEMITE Phase III study of zodasiran, which is being developed as a potential treatment for homozygous familial hypercholesterolemia or HoFH, a rare genetic condition that leads to severely elevated LDL cholesterol and early onset cardiovascular disease. Zodasiran is the fourth investigational RNAi-based candidate developed by Arrowhead to reach late-stage clinical studies. YOSEMITE is designed to enroll approximately 60 individuals with HoFH over the age of 12, who will be randomized 2:1 to receive 5 doses of 200 milligrams zodasiran or placebo. The primary endpoint is the percent change from baseline to month 12 in fasting LDL cholesterol. Enrollment has been on track and we are confident that the study can be fully enrolled this year to enable study completion and potential NDA filings before the end of 2027. The last program within cardiometabolic is ARO-DIMER-PA, the first dual functional siRNA designed to silence the expression of 2 genes with a single RNAi molecule. ARO-DIMER-PA is being developed as a potential treatment for ASCVD due to mixed hyperlipidemia by silencing expression of both PCSK9 and APOC3. In January, we initiated a Phase I/IIa placebo-controlled dose escalating study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and effects on LDL cholesterol and triglycerides using single-dose ARO-DIMER-PA in Part 1 and multiple doses in Part 2 in up to 78 adults with mixed hyperlipidemia. Enrollment in the study has been rapid and we are on schedule to have sufficient data to provide the first clinical readout in Q3 of this year. This is a very interesting program, and we think the preclinical data has been highly compelling. We have some innovative ideas on late-stage trial designs and potentially that potentially accelerate the path to regulatory approval. So we are eager to have the first clinical readout to start moving ahead later studies if supported by initial data. Lastly, I'd like to give an update on the status of the ARO-MAPT first-in-human study. ARO-MAPT is being developed as a potential treatment for tauopathies, including Alzheimer's disease, progressive neurodegenerative disease characterized by cognitive and functional decline. Alzheimer's disease is the most common cause of dementia affecting an estimated 32 million people worldwide and is part of a group of neurodegenerative diseases called tauopathies that are marked by abnormal tau accumulation and formation of tau tangles in neurons. Tau-related pathology may be a critical driver of neurodegeneration and targeting tau is a promising strategy to potentially slow or stop cognitive and functional decline. ARO-MAPT is Arrowhead's first investigational RNAi-based therapy to achieve a new proprietary delivery system, which in preclinical studies has achieved blood-brain barrier penetration and deep knockdown of target genes across central -- across the central nervous system, including deep brain regions after subcutaneous injection. This underscores Arrowhead's leadership in the delivery of siRNA to multiple tissues and cell types throughout the body, utilizing our proprietary and differentiated targeted RNAi molecule or TRiM platform. In December 2025, we dosed the first subjects in a Phase I/II clinical trial of ARO-MAPT. This study is a placebo-controlled dose escalating study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARO-MAPT in up to 64 healthy subjects and up to 48 patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia. In Part 1a of the study, healthy subjects will receive 1 or 3 weekly doses of ARO-MAPT or placebo by subcutaneous injection. In Parts 1b and Part 2, healthy volunteers and Alzheimer's disease patients, respectively, will receive multiple escalating doses of ARO-MAPT or placebo. We are nearing completion of enrollment of the single-dose portion of the study in healthy volunteers and have begun enrollment in the multi-dose cohorts in both healthy volunteers and patients with Alzheimer's disease. This keeps us on pace for an initial data readout at the end of Q3 or early Q4. I will now turn the call over to Dan Apel. Daniel Apel: Thank you, James, and good afternoon, everyone. As we reported today, net loss for the quarter ended March 31, 2026, was $132.7 million or a loss of $0.93 per share based on 142.4 million fully diluted weighted average shares outstanding. This compares to net income of $370.4 million or $2.75 per share for the quarter ended March 31, 2025, based on 134.5 million fully diluted weighted average shares outstanding in that quarter. Recall that in the prior year quarter, we recorded over $540 million in revenue solely related to the Sarepta transaction that was executed at that time. Revenue for this quarter totaled $74 million, driven primarily by our license and collaboration agreements with Sarepta and with Novartis. Of this amount, approximately $42 million related to the Sarepta collaboration. This includes $28 million from ongoing recognition of the initial Sarepta consideration, $10 million related to reimbursement of incurred preclinical collaboration program costs and $4 million for our clinical supply provided to them under a clinical supply agreement. In addition, we recognized $20 million of the $200 million upfront payment received from Novartis in October, bringing year-to-date recognition of Novartis upfront to $54 million, with the remaining $146 million to be deferred over time as we fulfill our preclinical obligations. We also recorded $11 million related to the asset purchase agreements between Sanofi and Visirna to develop and commercialize investigational plozasiran in Greater China. Visirna, as you know, is our majority-owned subsidiary with operations in China and the amount recognized is almost entirely due to the January approval of FCS in that region by the Chinese National Medical Products Administration. As mentioned previously, we are not intending to headline specific REDEMPLO product sales numbers until such time as they become a meaningful driver to our financials. That said, net sales can be derived from our disclosures as the difference between total net revenue and collaboration revenue and represents approximately $1 million for the quarter. This is our first full quarter of REDEMPLO sales. And on a unit basis, that figure compares favorably to the first full commercial quarter of the other approved APOC3 inhibitor. Turning now to expenses. Total operating expenses for the quarter were approximately $215 million, roughly flat with operating expenses in the first fiscal quarter. This compares to $162 million in the prior year quarter, representing an increase of $53 million year-over-year. This increase was driven by $40 million of higher R&D expenses and $13 million of higher SG&A expenses, fully in line with our expectations. The increase in R&D expense was primarily attributable to ongoing progression of our Phase III registrational studies for plozasiran in SHTG as well as our early-stage pipeline programs, including the dimer and MAPT. Fiscal year-to-date, almost 2/3 of the clinical trial spend can be attributed to our plozasiran Phase III studies. As James already mentioned, the registration of SHTG studies for plozasiran should readout in the summer and clinical trial spend for these programs should thereafter moderate accordingly. SG&A expenses increased year-over-year compared to the prior year second fiscal quarter, driven primarily by ongoing investments to support the commercialization of REDEMPLO. As previously discussed, we are continuing to build our commercial capabilities to fully support the FCS launch. We continue to leverage and invest in these capabilities to support REDEMPLO and FCS while also positioning the organization to support a potential future launch in SHTG. And we ultimately expect to leverage these same capabilities for the advancement of zodasiran for the treatment of HoFH. Turning to the balance sheet. Cash and investments on hand totaled nearly $1.8 billion as of March 31, 2026. Common shares outstanding at quarter end were 140.6 million. To provide a little color, in this quarter alone, we brought in over $1 billion, including approximately $850 million net from our January financing transactions, inclusive of a concurrent offering of 0% convertible senior notes and common stock, along with the associated capped call transaction. Other notable inflows in the quarter include the $200 million received from Sarepta upon achieving the second DM1 program milestone as well as the $50 million anniversary payment under the Sarepta long-term collaboration agreement. All of this is very much in line with the information provided previously during our February earnings call. We believe our strong balance sheet provides us with significant financial flexibility to support ongoing clinical development to advance current and future commercialization activities and to execute against our long-term strategic priorities. With that brief overview, I will now turn the call back to Chris. Dr. Christopher Anzalone: Thanks, Dan. As we build out our commercial team and focus on efficiently bringing REDEMPLO to patients who need it, we have not lost sight on continuing to expand our pipeline and ultimately increasing the number of medicines we can offer to a wide variety of patients. Our business has become more complex as we grow in all of these areas, where we continue to innovate and execute well. We see multiple key potential value-creating events in the second half of 2026 that together speak to our priorities. Here are just a few of the events we are tracking. SHASTA-3, SHASTA-4 and MURI-3, which is a suite of Phase III clinical studies designed to support an sNDA for REDEMPLO in patients with SHTG is on schedule for completion and top line readout in Q3. The first clinical readout of ARO-DIMER-PA targeting both PCSK9 and APOC3 for LDL and TG lowering is also expected in Q3. The first clinical readout for ARO-MAPT is expected around the end of Q3 or early Q4. It is being developed as a potential treatment for tauopathies, including Alzheimer's disease and is our first program using the CNS delivery platform designed to cross the blood-brain barrier after systemic delivery via subcutaneous administration. Additional ARO-INHBE and ARO-ALK7 data releases are planned in 2026 for this novel non-incretin strategy, which had quite encouraging early data, particularly in diabetic obese patients in combination with tirzepatide and with liver fat reductions as monotherapy or in combination with tirzepatide. As James mentioned, we are planning to webcast 3 presentations as part of our summer series of R&D webinars to go over cardiometabolic broadly, obesity and ARO-MAPT. These can serve as a review of the programs and results to date and as a primer for the potentially important readouts coming up later this year. Thank you for joining us today. I would now like to open the call to your questions. Operator: At this time we will now conduct the question-and-answer session. [Operator Instructions] Our first question comes from the line of Edward Tenthoff from Piper Sandler. Edward Tenthoff: My question really has to do with looking at the upcoming SH, severe hypertriglyceridemia readout. When it comes to pancreatitis as a secondary, is the plan to pool SHASTA-3 and 4? And what are sort of the assumptions around pancreatitis? James Hamilton: Yes, Ted, thanks for the question. This is James. Yes, you've got that right. The plan is to pool both of those studies, SHASTA-3 and -4, and we'll analyze meta-analysis of those 2 studies to look at pancreatitis event rates, both rates of events in individual patients and a total number of overall events. I think that's kind of all I can say on that. We're still blinded. And like we said, should have the data in Q3. Edward Tenthoff: Great. Looking forward to that. Operator: [Operator Instructions] Our next question comes from Jason Gerberry of Bank of America. Jason Gerberry: I just wanted to probe in a little bit more on the INHBE and ALK 7 updates later this year and get your latest thoughts on these modalities and think investors have soured a little bit on INHBE after the WAVE data update. So just wanted to get your perspective on kind of what you need to see from these upcoming readouts to advance one or both for obesity treatment versus any alternative potentially considering for a NASH indication. James Hamilton: Jason, this is James. Sure. Happy to cover those questions. We've been saying all along really that we thought that this INHBE ALK 7 access is interesting, but we thought the approach was to combine with GLP-1s. And that is still our standpoint here. We think that there's potential, particularly in the type 2 diabetics for additional weight loss on top of tirzepatide or other GLP-1s with either ALK 7 knockdown or INHBE knockdown. What we've seen from the clinical study that we talked about earlier this year from INHBE -- with INHBE knockdown is really clear redistribution of fat out of the liver, even with monotherapy, but also with combination therapy and some additional changes and improvements in body composition and reductions in total fat and visceral fat, particularly in that type 2 diabetic population. So I think we look forward to more of the same and sharing more of that liver fat data here in the coming quarter or so and then in the second half of the year, providing some additional updates on the changes in body composition and some of the other parameters that we showed back in January. Operator: Our next question comes from Brian Cheng of JPMorgan. Ron Feiner: This is Ron on for Brian. Congrats on the quarter. Just wanted to ask you, can you guys give more color on the interactions you've had with payers that led to the recent price lowering? And what has been the feedback since your competitive action last month? Andy Davis: Ron, this is Andy. So our interactions with payers to date have been consistent, have been positive, and we're seeing payer policies, and these are public payer policies that reflect the ability to diagnose FCS patients through multiple diagnosis pathways, in particular, through the clinical criteria that we saw in PALISADE. So really, really positive conversations with payers about payer policies and about future coverage. Ron Feiner: Okay. And just a quick follow-up. Could you guys how should we think about the impact here to gross to net following the price lowering? Dr. Christopher Anzalone: Well, gross to net. And Dan will take that. What's our assumption on gross to net with the new pricing policy? Daniel Apel: Yes. So we -- I mean, we -- I'll just answer your second question, with more in line to -- as Chris already explained, to make a premium price to the competitor there. We are -- I'm not actually going to give guidance on gross to net. We have not seen anything substantial in that regard nor do we currently expect that other than things that are statutory required such as Medicaid rebates and the manufacture discount program and the like. So -- but we have a policy not to provide any sort of guidance or -- on that at this stage. Dr. Christopher Anzalone: And let's just be clear, the lowering of the WAC from $60,000 to $45,000 had nothing to do with any pushback from the payers. To the contrary, I think that those interactions have been quite positive. This is a lowering of the WAC in expectation of an expectation of, of an expansion the market into SHTG and to ensure that we are -- that we would -- the payers would not require a step through with our competitor. As we talked about, we are priced at a premium here. We think that's appropriate given the characteristics of our drug versus the competitors' drug. And we think $45,000 actually long term is probably quite a good price in terms of maximizing access to the drug across various subpopulations within SHTG. Operator: [Operator Instructions] Our next question comes from Mike Ols from Morgan Stanley. Avraham Novick: This is Avi Novick on for Mike. Congrats on the quarter. I guess among the patients who were switchers, could you characterize, I guess, the motivations for switching to REDEMPLO? Was it due to its clinical profile? Or could it be more payer related? Andy Davis: Mike, this is Andy. Thanks for the question. We've seen really diversity of reasons for switch that include efficacy, safety and tolerability and a variety of other reasons as well. So I wouldn't say there's one particular reason driving switch. There's a multitude of reasons. Operator: [Operator Instructions] Our next question comes from Maury Raycroft from Jefferies. Maurice Raycroft: Maybe just a follow-up to Ted's question earlier on SHASTA-3 and -4. Just wondering if there's an updated perspective on whether the blinded AP event rates are tracking in line with your expectations and whether you'd be able to generate enough events by the time the study completes? Or could you potentially even keep the study blinded a little bit longer to get an adequate number of total events? James Hamilton: Maury, this is James. I'll take that question. So we're not giving any guidance on or sort of blow-by-blow details on the number of events we're seeing. Suffice it to say, we feel comfortable with the number of events we have seen and the big reveal will be in Q3. But no plans to extend the study or stay blinded for a longer period at this time. Operator: [Operator Instructions] Our next question comes from Mani Foroohar from Leerink. Unknown Analyst: You have [ Val ] for Mani. Congrats on the quarter. So yes, can you talk about how the Phase III data from Biogen will inform the strategy for ARO-MAPT? And maybe also can you just comment on your internal expectations for this readout? Dr. Christopher Anzalone: I don't think any of us caught that. Could you say that again? I think the line is a bit muddled. Unknown Analyst: Sorry. No, yes, I was asking if you could talk about the Phase III SLE data from Biogen and how it will inform your strategy for ARO-MAPT and can you also talk about internal expectations? James Hamilton: Sure. Yes, I can take that. This is James. So the -- I'm assuming you're referring to the ASO starting MAPT from Biogen and Ionis that's supposed to readout here in maybe this quarter or early next quarter. Yes, I mean, I hope those data look good, and I hope that they show an improvement in the cognitive rating scales. I think that would be broadly positive for Arrowhead and for the tau hypothesis in general. Of course, that study is in Alzheimer's disease. and a positive readout would support our Alzheimer's programs. That being said, even if those data are not positive, I think we can still -- we still have the option of pursuing all the other tauopathies, right, because the knockdown approach of tau should improve any condition that's really driven by tau gain of function or tau pathology. So things like progressive supranuclear palsy or corticobasal dementia or some of the real specific MAPT gain of function frontotemporal dementia disorders. Those are all fair game for us as we think about Phase IIs and Phase III down the road. So hopefully, the Biogen data are positive. If it's not -- it's not the end of the world for our program because we can still pursue the tauopathies. Operator: [Operator Instructions] Our next question comes from Joseph Thome from TD Cowen. Joseph Thome: Just as we're thinking about the potential outcomes for the SHASTA-3, -4 studies later this year, do you expect that you'll have to show differentiated efficacy versus what Ionis has shown in addition to the dosing benefit in order to keep that even slightly premium pricing? And then just a point of clarification, are you characterizing the AP events in SHASTA-3, -4 the same way that you characterized them in the long-term of SHASTA-2 extension that was recently presented? James Hamilton: Why don't I take the second part first about the characterization. The answer is no. So the SHASTA-2 study, we used the strict Atlanta criteria to look at pancreatitis events, whereas in the SHASA-3, -4 pooled analysis, we're using this to modify the Atlanta criteria that has definite probable and possible pancreatitis. And regarding the premium pricing, let's just see what those data look like. Dr. Christopher Anzalone: Historically, when we look at data side by side with the large caveat, of course, it's difficult to compare different clinical studies with different patient populations. What we have seen consistently is superior triglyceride reduction, superior safety profile and of course, superior convenience. We expect those to continue. And should that be the case, then we would expect that a premium is still appropriate. Operator: Our next question comes from Patrick Trucchio of H.C. Wainwright. Patrick Trucchio: Just regarding your business development strategy, I was hoping you could give us some additional detail just in terms of which assets you would be looking to bring forward on your own versus those that you may partner? And then just more broadly, how you're thinking about how RNAi kind of fits into the broader genetic medicines sort of portfolio and how RNAi is looking sort of competitively against modalities like gene editing, et cetera? Dr. Christopher Anzalone: Sure. Look, I think that RNAi is at the forefront of genetic medicine for the foreseeable future. Now look, it's not the right modality for everything. But for those diseases that are characterized by the overproduction of something, if we can address that cell type, then RNAi is a very attractive modality. But when we think about RNAi versus gene editing, the way I feel at least is that RNAi is a relatively straightforward and conservative approach, right? It is a reversible approach. And in our hands, we can have very long durability space. So you can almost get the best of both worlds where you have a low needle burden, if you will, but the ability to come off drug should some new biology come out to suggest that you don't actually want to knock down that gene product. That's not the case in gene editing. And I think that gene editing does have a place in the world of medicine. It's just quite unknown right now because I don't know what happens to these edited genes 10 years from now. I don't think anybody does, notwithstanding as the biology changes and it could be that sometime in the future, we decide that they might not want to knock down a certain gene product. So for those horrible diseases that are terminal, it could be worth taking a risk to do gene editing. But frankly, for all others, if you can address something with RNAi, that feels to me a better approach. Regarding to the development, this is a dynamic question. Right now, we feel pretty good about our existing pipeline in terms of that, which is wholly owned right now. We like the idea of pushing all these forward ourselves with the possible exception of C3 and Factor B, we like those programs a lot. Those drug candidates appear to do what they're intended to do and they seem to be well tolerated. Those are just really outside of our core focus at present. And so those are a couple of assets that we could partner with the right partner at some point. Everything else feels pretty good right now. Look, that may change as we talk to other companies and as our pipeline grows, but we don't feel a real sense of urgency to do additional deals on existing clinical programs other than maybe C3 and Factor B. Operator: Our next question comes from Amine Chaherli from B. Riley Securities. Amine Chaherli: Congratulations on the quarter. This is Amine Chaherli on behalf of Madison El-Saadi. I just wanted to ask, as you think about the next generation of the dimer platform, is a construct combining INHBE or ALK 7 with a nonoverlapping mechanism target, something you're evaluating for obesity or other indications? Dr. Christopher Anzalone: Yes. James Hamilton: Can we move on to next question. Operator: Yes. Our next question comes from Luca Issi from RBC Capital Markets. Shelby Hill: This is Shelby on for Luca. Given Ionis has announced a new price at $40,000 and have first-mover advantage, can you walk us through the rationale to continue to price for REDEMPLO at a premium versus Zeptar in SHTG maybe as a way to kind of undercut their pricing since you're coming in second. Just wondering the rationale behind that. Andy Davis: Yes. Thanks, Shelby. As Chris previously mentioned, we do believe REDEMPLO is a best-in-class APOC3 inhibitor and that it commands premium pricing as a consequence of that. And there are a variety of reasons for that. Chris touched on some of them, including the depth of knockdown for APOC3 as a target, the depth of TG reduction. We saw that from PALISADE with an 80% reduction from baseline. We saw that with the numerical decrease in acute pancreatitis from PALISADE. We've seen that also with an FDA label that has no contraindications, no warnings and no precautions. And then lastly, with a convenient dosing schedule that's only 4 injections a year. When you sum up the totality of those attributes, we just believe it's a best-in-class APOC3 inhibitor and as a consequence, should be premium priced. Operator: Our next call -- our next question comes from Jen Jia from Cantor Fitzgerald. Jennifer Jia: This is Jennifer Jia on for Prakhar Agrawal. I'd like to understand a little bit more on the expectations for ARO-DIMER readout later this year. So what efficacy are you hoping to see? And what does it take to take this forward to a larger trial? And if it's positive, do you consider going straight to a cardio outcomes trial? Or will you still need to complete a Phase II? James Hamilton: Yes, Jennifer, this is James. Happy to address that question. So the great thing about this program is that all of the relevant biomarkers and even biomarkers that you could use for potentially for approval are blood-based, right? We can measure CSTK-09, we can measure APOC3 in the blood, and we can measure LDL cholesterol and triglycerides, Apo B, non-HDL cholesterol are all pretty easy for us to measure. So that's what we'll be primarily focused on as well as safety in this initial data readout. In terms of where we go from here, I think we're working on that now. There may be some additional limited Phase II work, which we could even consider doing as part of this study, but then moving quickly into an outcome study down the road. So more to come on the development plan and the study designs, but looking forward to the readout later this year. Operator: Our next question comes from Keay Nakae from Chardan Capital Markets. Kaey Nakae: A question about the Madrigal license agreement for PNPLA. Help us understand from a capital allocation strategy perspective, why it makes sense for you to do this deal at this time as opposed to taking the drug further on your own? Dr. Christopher Anzalone: Yes, good question. So let me just take it back and remind everyone that where ARO- PNPLA3 came from. We didn't develop this on our own independently. This is part of our deal with Janssen that was centered around [ HBV FSP ], but also included a couple of additional targets. This was one of those targets. And so we developed it for them. They did the Phase I. The Phase I was compelling. After only a single dose, they saw about a 40% reduction in liver fat in homozygous patients. So that was interesting to us. Janssen, as I understand, decided to get out of NASH. And so the asset was returned to us. We didn't spend any money on this. As we look at taking this forward, we think it's a really compelling target for a company that's focused in NASH largely. This is a genetically defined population. And that's sort of the good news and the bad news, right? The good news is it's quite specific. The challenge there is that there will be a companion diagnostic component to this. And it made sense for us to find a pure-play NASH company to take this forward. And of course, Madrigal is, I think, the best that's out there right now. It doesn't make sense. It didn't really make sense for us to spend much money right now to do a Phase II. Those studies could be a bit long and more expensive than made sense for us. We've got a very large pipeline. We've got some really interesting programs that we are pushing ourselves. And I just think that our ROI is probably better by allocating capital to those programs that we are more confident that we will hold on to long term. So that's where we went. We are thrilled to have Madrigal as a partner. We're thrilled to have them develop that drug. It's a good drug, and we're thrilled to have them commercialize eventually. So we feel good about the deal. Operator: This concludes the question-and-answer session. I would now like to turn it back to Chris Anzalone for closing remarks. Dr. Christopher Anzalone: Thanks, everyone, for joining us today. We look forward to seeing you in the future. Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Before you buy stock in Arrowhead Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Arrowhead Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $475,926!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,296,608!* Now, it’s worth noting Stock Advisor’s total average return is 981% — a market-crushing outperformance compared to 205% for the S&P 500. 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- Conference Call and Webcast Today, May 7, 2026, at 4:30 p.m. ET PASADENA, Calif., May 07, 2026--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2026 second quarter ended March 31, 2026. The Company is hosting a conference call today, May 7, 2026, at 4:30 p.m. ET to discuss the results. "Arrowhead continues to show strong execution in meeting and exceeding our commercial, R&D, and corporate goals. The company is on extremely strong footing to continue to drive growth in the near-term with numerous opportunities to create long-term shareholder value," said Christopher Anzalone, Ph.D., President and CEO at Arrowhead Pharmaceuticals. "We remain focused on a few key areas as being critical sources of sustainable growth for Arrowhead, and we have made tangible advancements across these areas. These include: strengthening our commercial presence to bring REDEMPLO® and potentially other cardiometabolic products in the future to the many patients and physicians who need it; continuing to deliver best-in-class in discovery, development, and regulatory capabilities in support of a deep pipeline of RNAi therapeutics capable of silencing genes expressed throughout the body to treat various diseases; and, being strategic and disciplined around pipeline, portfolio, and financial management." Key REDEMPLO® Commercial Events Continued to build strong and consistent momentum since launching REDEMPLO (plozasiran) independently in the U.S. following its approval by the FDA on November 18, 2025, as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). Key metrics include: Total prescriptions received and in process to date exceeds 400, representing greater than 40% growth over just the last four weeks alone; A total of approximately 180 patients to date have received at least one pre-filled syringe shipment; New weekly prescriptions are accelerating - currently averaging approximately 30 new written prescriptions per week; Approximately 85% of prescriptions were for patients naive to the APOC3 class — a strong signal that physicians are identifying and treating patients with FCS who have never had access to an effective therapy. Patients switching from other APOC3 targeted therapies largely account for the remainder; Updated the U.S. wholesale acquisition cost (WAC) of REDEMPLO to $45,000 per patient per year, representing a premium to the competing APOC3 inhibitor approved for FCS which the company believes is supported by its clinical evidence. This price reflects Arrowhead’s commitment to optimize market access for all patients with FCS. As part of the One-REDEMPLO unified pricing model, the new price is intended to remain consistent across FCS and severe hypertriglyceridemia (SHTG), if that indication is approved, which potentially simplifies payer contracting and eliminates pricing complexity that could complicate future formulary negotiations; Key R&D Events Following U.S. FDA approval of REDEMPLO in 2025, secured positive regulatory action in four additional geographies for patients with genetically confirmed and clinically diagnosed FCS: The Australian Therapeutic Goods Administration (TGA) approved REDEMPLO (plozasiran), as an adjunct to diet to reduce triglyceride levels for adult patients with familial chylomicronaemia syndrome in Australia; Received positive CHMP opinion recommending approval of REDEMPLO (plozasiran) to reduce triglycerides in adults with familial chylomicronemia syndrome in Europe. The European Commission is expected to issue a decision on REDEMPLO’s Marketing Authorization in the second quarter of 2026; The Chinese National Medical Products Administration (NMPA) approved REDEMPLO (plozasiran) for the reduction of triglyceride levels in adult patients with familial chylomicronemia syndrome. REDEMPLO will be marketed in Greater China by Sanofi under an agreement between Sanofi and Arrowhead; Health Canada issued a Notice of Compliance (NOC) authorizing REDEMPLO (plozasiran) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome for whom standard triglyceride lowering therapies have been inadequate. REDEMPLO is expected to be available later this year in Canada and the company anticipates it will be marketed independently by Arrowhead; Presented new long-term efficacy and safety data for plozasiran across a spectrum of hypertriglyceridemia at the American College of Cardiology’s 75th Annual Scientific Session and Expo. Key highlights include: Patients with severe hypertriglyceridemia achieved an 83% median reduction in triglycerides (TG), with 96% of patients achieving TG levels below 500 mg/dL, a threshold associated with increased risk of acute pancreatitis; No adjudicated acute pancreatitis events occurred in any patient receiving plozasiran during the two-year Phase 2b open-label expansion (OLE) study; Favorable and durable improvements in atherogenic lipoproteins, including remnant cholesterol, non-HDL cholesterol, and ApoB, were observed, with a safety profile consistent with earlier trials; Initiated and dosed the first subjects in a Phase 1/2a clinical trial of ARO-DIMER-PA, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for atherosclerotic cardiovascular disease (ASCVD) due to mixed hyperlipidemia: ARO-DIMER-PA is designed to silence expression of the proprotein convertase subtilisin kexin 9 (PCSK9) and apolipoprotein C3 (APOC3) genes. This represents an important step forward for the RNAi field as it is the first dual-functional clinical candidate to target two genes simultaneously in one molecule; Announced interim clinical data on our RNAi-based obesity candidates, ARO-INHBE and ARO-ALK7, showing weight loss in obese patients with diabetes and improved measures of body composition; In obese patients with type 2 diabetes mellitus, ARO-INHBE in combination with tirzepatide achieved -9.4% weight loss at week 16, representing an approximately two-fold improvement versus -4.8% on tirzepatide alone; ARO-INHBE drove robust fat reduction including -23.2% visceral fat, -15.4% total fat, and -76.7% liver fat reduction, representing an approximately three-fold improvement in all three measures versus tirzepatide alone in obese diabetic patients; ARO-ALK7 is the first RNAi-therapeutic to show knockdown in humans of an adipocyte expressed gene, achieving a mean reduction of -88% in ALK7 mRNA with a maximum reduction of -94%; ARO-ALK7 monotherapy achieved a reduction of -14.1% (single dose, week 8) in placebo adjusted visceral fat; Key Corporate Events Announced, earlier this week, an exclusive worldwide license agreement with Madrigal Pharmaceuticals for ARO-PNPLA3, Arrowhead’s clinical stage RNAi therapeutic designed to reduce liver expression of patatin-like phospholipase domain containing 3 (PNPLA3) as a potential treatment for patients with metabolic dysfunction-associated steatohepatitis (MASH): Under the terms of the agreement, Madrigal will make a $25 million upfront payment to Arrowhead. Arrowhead is also eligible to receive development, regulatory, and sales milestone payments of up to $975 million. Arrowhead is further eligible to receive tiered royalties on commercial sales ranging from high-single digits to the mid-teens; In a Phase 1 single-ascending dose clinical study, ARO-PNPLA3 achieved encouraging results, including a dose-dependent mean reduction in liver fat of up to 40% in patients homozygous for the I148M mutation, no apparent treatment emergent increases in triglycerides or LDL-cholesterol, and a positive safety and tolerability profile at all doses studied; Meaningfully strengthened the balance sheet through two concurrent public offerings with gross proceeds totaling $930 million and consisting of: $700 million of 0.00% convertible senior notes with a 35% conversion premium (initial conversion price of approximately $87.08 per share of common stock) due 2032; $230 million through issuance of shares of common stock, at a public offering price of $64.50 per share (or, in lieu of shares of common stock to certain investors, pre-funded warrants); A capped call transaction to reduce dilution, with the cap price set at $119.33, representing a premium of approximately 85% over the public offering price of $64.50 per share in the common stock offering; Webcast and Conference Call and Details Investors may access a live audio webcast on the Events and Presentations page under the Investors section of the Arrowhead website. A replay of the webcast will be available approximately two hours after the conclusion of the call. For analysts that wish to participate in the conference call, please register at https://register-conf.media-server.com/register/BI94a3f6754bd3471e8e895704fb645ee5. Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call. Selected Fiscal 2026 Second Quarter Financial Results About REDEMPLO® (plozasiran) REDEMPLO (plozasiran) is approved by the U.S. Food and Drug Administration as an adjunct to diet to reduce triglycerides in adults with Familial Chylomicronemia Syndrome (FCS). REDEMPLO is an siRNA therapeutic designed to suppress the production of apoC-III, a protein produced in the liver that raises triglyceride levels by slowing their breakdown and clearance. By targeting apoC-III with sustained silencing, REDEMPLO delivers significant reductions in triglyceride levels. REDEMPLO is the first and only siRNA FDA-approved treatment studied in both genetically confirmed and clinically diagnosed patients living with FCS. For more information about REDEMPLO, visit Our Medicines. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS None. ADVERSE REACTIONS Most common adverse reactions in REDEMPLO treated patients (incidence ≥10% of patients treated with REDEMPLO and >5% more frequently than with placebo) are hyperglycemia, headache, nausea, and injection site reaction. Please see full U.S. Prescribing Information for REDEMPLO®. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals (NASDAQ: ARWR) is a commercial-stage pharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them, harnessing the natural RNA interference (RNAi) mechanism. The company has built a broad portfolio of clinical and commercial RNAi therapeutics through its industry-leading targeted RNAi molecule (TRiM™) platform, which can precisely silence genes in a wide range of cell types, including liver, lung, muscle, adipose, and central nervous system tissue. At Arrowhead, we rapidly advance potential best- and first-in-class RNAi treatments for diseases with significant unmet medical need, because every day matters to the patients we serve. For more information, please visit www.arrowheadpharma.com, or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts. Safe Harbor Statement under the Private Securities Litigation Reform Act: This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "expect," "believe," "anticipate," "hope," "intend," "plan," "project," "could," "estimate," "continue," "target," "forecast" or "continue" or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline, products or product candidate or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about our beliefs and expectations regarding the long-term impacts of REDEMPLO® (plozasiran) on patient health and the health care system; our beliefs and expectations regarding the pricing, value, or expected timing for availability of our drugs and drug candidates; and our believes and expectations around the potential uses and value of the TRiM™ platform. These statements are based upon our current expectations and speak only as of the date hereof. Actual results or outcomes may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties the safety and efficacy of our products and product candidates, pricing and reimbursement decisions related to our products, demand for our products, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances. Source: Arrowhead Pharmaceuticals, Inc. View source version on businesswire.com: https://www.businesswire.com/news/home/20260507696321/en/ Contacts Arrowhead Pharmaceuticals, Inc. Vince Anzalone, CFA 626-304-3400 [email protected] Investors: LifeSci Advisors, LLC Brian Ritchie 212-915-2578 [email protected] Media: LifeSci Communications, LLC Kendy Guarinoni, Ph.D. 724-910-9389 [email protected]