Aug 4, 2026 earnings call — SHASTA pivotal trial success and priority review voucher
Both SHASTA studies met primary endpoints with median triglyceride reductions of 79% and 81% and a 78% reduction in acute pancreatitis events.
Revenue $0.1B (est $0.0B) · EPS $-1.36 (est $-1.28)
Key quotes
"Median triglyceride reductions from baseline were 79% and 81% in SHASTA-3 and SHASTA-4, respectively."
"REDEMPLO prescription volume has more than doubled over the course of the fiscal third quarter, and that momentum has continued into the current quarter."
"Under the terms of the APA, we will pay the current holder $215 million at closing, which we expect to occur in our fiscal fourth quarter following HSR Clearance."
Analyst Q&A 12
sNDA filing timeline and ESC data
Q (Maurice Raycroft · Jefferies): Analyst asked for a timeline to submit the sNDA by year-end 2026 and what could block that. He also asked about expectations for the ESC late-breaker data and whether there were any liver fat, ALT, or glycemic imbalances.
A: Management said they are under embargo for the ESC data and cannot discuss details before the conference. For the sNDA they plan a pre-sNDA meeting with FDA and then will file after discussions. The team is focused on preparing sNDA modules, study reports, and finalizing the data needed by year-end.
"In terms of rate limiters for the sNDA, we do plan to have a pre-sNDA meeting with FDA and then subsequent to our discussions with the agency would file the submission." — James Hamilton
ARO-MAPT September data and knockdown target
Q (Michael Ulz · Morgan Stanley): Analyst asked what top-line data will be shared in September for ARO-MAPT and what level of tau knockdown they expect. He also asked if that target changed after seeing Biogen data.
A: Management said the September data will be only in healthy volunteers and will focus on safety and total tau knockdown. They reiterated their knockdown target of about 50% to 60%, which they have kept as a benchmark. There are few other biomarkers available in healthy volunteers, so the readout is mostly safety and pharmacodynamic.
"We'll be discussing primarily safety and then total tau knockdown." — James Hamilton
Sales force size and timing for sHTG
Q (Lut Ming Cheng · JPMorgan): Analyst asked how large the sales force will need to be and how the scale-up will be sequenced over the next months into the label expansion decision.
A: Management would not give exact field force size but said they will expand target coverage from effectively over 5,000 HCPs to over 20,000 HCPs. They expect final onboarding and optimization of the field force before the end of the year to prepare for a potential accelerated launch in sHTG in Q2 next year. They plan to include both specialists and some primary care physicians who act like specialists.
"So we would anticipate the final onboarding of the optimization of our field force to happen before the end of the year as we prepare for a potential accelerated launch in sHTG in the second quarter of next year." — Andy Davis
SHASTA MRI sample and SHASTA-5 plans
Q (Luca Issi · RBC): Analyst asked what proportion of SHASTA-3 and SHASTA-4 patients had MRI at baseline in year 1 to gauge sample size. He also asked whether SHASTA-5 will continue or be wound down now that SHASTA-3/4 are in-house.
A: Management said they cannot give details on SHASTA-3 or SHASTA-4 because the data are under embargo and will be presented at ESC. For SHASTA-5 they have no plans to terminate the study and will continue enrolling and running it as status quo while they better understand the label. No changes are planned now.
"For SHASTA-5, we don't have any plans to terminate that study right now." — James Hamilton
Responder thresholds and Part D timing
Q (Dina Ramadane · BofA): Analyst asked which triglyceride responder threshold (below 500 or below 150) matters more for showing strong TG lowering. She also asked whether the priority review voucher (PRV) will allow Part D coverage for most of 2027 or only the second half.
A: Management said they must wait until ESC to show the actual responder data, but noted the 500 mg per deciliter threshold is the sHTG cutoff linked to reduced acute pancreatitis risk and that is their current focus. They also said both 150 and 500 are important, they aim to get as many patients below 500 as possible, and market access will engage payers after data publication to prepare coverage through 2027. They did not commit to exact Part D timing but described active payer engagement.
"But I mean, for sHTG, 500 mg per deciliter is the threshold and it's thought to be below that, you should reduce the risk for acute pancreatitis, which is really where we're focused with the drug right now." — James Hamilton
US vs Europe prescribing and revenue split
Q (Joseph Thome · TD Cowen): Analyst asked how prescribing might differ between the U.S. and Europe for sHTG and what portion of the quoted $3 billion to $4 billion opportunity is U.S.-based versus international.
A: Management said the overwhelming majority of that $3 billion to $4 billion estimate is in the United States. They added that both U.S. and European markets are outcomes-driven and the pooled SHASTA result is important for demonstrating value in Europe. They also noted uncertainty around MFN makes forecasting ex-U.S. revenues difficult.
"Yes, I'll take the easy question -- the second question, the majority of that is in the United States, the overwhelming majority of that." — Dr. Christopher Anzalone (CEO)
TRIGS commercial ramp and class validation
Q (James Condulis · Stifel): Analyst asked what analogs to use to think about TRIGS commercial opportunity and how important the initial quarters are in validating the class opportunity.
A: Management said they will move quickly at launch, focus on provider education and work with payers to publish policies and coverage. They noted high overlap between FCS prescribers and sHTG prescribers with about 1,500 lipid-interested clinicians in the U.S. They also cautioned the ramp will be relatively slow because this is a new market that requires educating physicians and patients.
"However, this is going to be a relatively slow ramp because this is a brand-new market." — Dr. Christopher Anzalone (CEO)
Prescription run rate and ESC implications
Q (Madison Wynne El-Saadi · B. Riley): Analyst asked how to think about doubling REDEMPLO prescriptions in weekly run rate and whether prescription-to-drug conversion for FCS is steady. She also asked if ESC learnings will be academic or inform label/cross-trial comparison.
A: Management said the current run rate is approximately 20 to 30 new prescriptions per week, consistent with prior disclosures. They are focused on moving prescriptions through the funnel to shipments via market access support and new field personnel being deployed this month, which they expect to help inflect prescriptions and conversions. On ESC, management declined to comment further because the data remain under embargo.
"Yes, we do see approximately 20 to 30 new prescriptions a week that has been the run rate and consistent with what we have communicated previously." — Andy Davis
Initial patient targeting and field scaling
Q (Luis Santos · H.C. Wainwright): Analyst asked whether the sHTG launch will focus on the highest-risk patients or be broader across patients with TGs above 500, and whether the commercial build will be a step function or incremental expansion of the FCS field force.
A: Management said they will initially focus on the highest-risk sHTG patients, who have the greatest unmet need and payer willingness to pay. They implemented a step function increase in the field force that goes into the field this month and will continue to optimize it approaching sHTG launch. Management also said the data suggest treating patients above 500 is important and there is a broader market, but education will be required.
"Certainly, while we think the top line results support REDEMPLO across the spectrum of sHTG patients, naturally, we'll be focused on those high-risk sHTG patients out of the gate." — Andy Davis
Pricing versus Tryngolza
Q (Kaey Nakae · Chardan): Analyst asked how they are thinking about price differential versus Tryngolza now that they have data.
A: Management said they would not discuss detailed pricing strategy on the call, but reminded listeners that the wholesale acquisition cost for REDEMPLO is USD 45,000 per year and they believe the premium versus the competitor is justified by product attributes. They added they do not intend to move the price now that they have the data and believe the current price is appropriate given efficacy, safety, convenience, and dosing simplicity.
"If the question is, do we intend to move that price now that we have these data, the answer is no." — Dr. Christopher Anzalone (CEO)
Other neuro gene targets if MAPT succeeds
Q (Jennifer Jia · Cantor Fitzgerald): Analyst asked what other gene targets (TMS targets) the company is excited about if the MAPT program is positive.
A: Management said they have many different targets but have not disclosed them. They said they probably will not disclose those wholly owned programs until around the time of the CTA filing because of competitive reasons in the siRNA space. They asked investors to stay tuned for future disclosures.
"We haven't disclosed any of those in terms of wholly owned programs, we probably won't disclose those until around the time of the CTA filing, just given the competitive nature in the siRNA space right now." — James Hamilton
International commercialization and revenue recognition
Q (Edward Tenthoff · Piper Sandler): Analyst asked whether Arrowhead will directly market REDEMPLO or use distributors in the countries where approved, and how revenue will be recognized and whether distributor fees appear in SG&A.
A: Management said they are marketing in those countries via commercial partners rather than out-licensing or using distributors, with Arrowhead operating with commercial partners except in China. For revenue recognition, they follow standard practice and will recognize revenue as they complete sales to customers; gross sales will be adjusted for distribution costs and contract marketing support will show up in marketing and sales costs. No unique revenue recognition treatment was described.
"So as we complete a sale to customers in those countries, we will recognize revenue." — Daniel Apel (CFO)