Q2 2026 Arrowhead Pharmaceuticals Inc Earnings Call

May 7, 2026

Operator: All participants will be in listen-only mode. After the presentation, there will be an opportunity to ask questions. Instruction will follow at that time. I will now hand the conference call over to Vincent Anzalone, Senior Vice President of Investor Relations for Arrowhead. Please go ahead, Vince.

Speaker #1: Participants will be in listen-only mode. After the presentation, there will be an opportunity to ask questions, instruction will follow at that time. I will now hand the conference call over to Vince Anzalone, Senior Vice President of Investor Relations for Arrowhead.

Speaker #3: reduce triglycerides in adults with FTS. FTS is a severe Let's talk about some of our rare disease with an estimated 6,500 people in the US living with genetic or clinical FTS characterized by TG levels that can be 10 to 100 times higher than normal.

Speaker #2: Instruction will follow at that time. I will now hand the conference call over to Vince Anzalone, Senior Vice President

Speaker #2: Investor Relations for gentlemen, welcome to the Arrowhead.

Speaker #2: ARROWHEAD. Please go ahead,

Speaker #2: Vince.

Speaker #1: Please go ahead, Vince.

Speaker #3: This leads to a substantially increased risk of developing acute recurrent and potentially fatal pancreatitis. As reported last quarter, the US REDEMPLO launch was off to a strong start.

Speaker #3: Good afternoon, and thank you for joining us today to

Speaker #2: Good afternoon, and thank you for joining us today to discuss Arrowhead's results for its fiscal 2026 second quarter ended March 31, 2026. With us today from management are President and CEO, Dr. Chris Anzalone, who will provide an overview; Andy Davis, Senior Vice President and Head of the Global Cardiometabolic Franchise; who will provide an update on commercialization activities; Dr. James Hamilton, Chief Medical Officer and Head of R&D, who will discuss our development programs; and Dan Appel, Chief Financial Officer, who will give a review of the financials.

Vincent Anzalone: Good afternoon, and thank you for joining us today to discuss Arrowhead's results for its fiscal 2026 Q2 ended 31 March 2026. With us today from management, our President and Chief Executive Officer, Dr. Chris Anzalone, who will provide an overview. Andy Davis, Senior Vice President and Head of the Global Cardiometabolic Franchise, who will provide an update on commercialization activities. Dr. James Hamilton, Chief Medical Officer and Head of R&D, who will discuss our development programs, and Daniel Apel, Chief Financial Officer, who will give a review of the financials. Following management's prepared remarks, we will open the call to questions. Before we begin, I would like to remind you that comments made during today's call contain certain forward-looking statements within the meaning of Section 27 of the Securities Act of 1933 and Section 21 of the Securities Exchange Act of 1934.

Speaker #3: 2026 second quarter ended March 31,

Speaker #3: With us today from management are President and CEO, Dr.

Speaker #3: 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

Speaker #3: Chris Anzalone, who will provide an

Speaker #3: President and Head of the Global

Speaker #3: For the Cardiometabolic Franchise, Andy Davis will provide an update.

Speaker #3: Of course, each prescription

Speaker #3: our development programs; and

Speaker #3: payers, before becoming paid

Speaker #3: quick-start program to support these FTS patients in patients receiving REDEMPLO continues to The volume

Speaker #3: Following management's prepared

Speaker #2: Following management's prepared remarks, we will open the call to questions. Before we begin, I would like to remind you that comments made during today's call contain certain forward-looking statements within the meaning of Section 27(a) of the Securities Act of 1933 and Section 21(e) of the Securities Exchange Act of 1934.

Speaker #3: questions. Before we begin, I would like to

Speaker #3: of physicians writing prescriptions and the inhibitor.

Speaker #3: remind you that comments made during today's call contain certain

Speaker #3: continues to exceed our initial

Speaker #3: forward-looking statements within the meaning of Section 27(a) of the Securities

Speaker #3: pricing, we updated REDEMPLO's US wholesale acquisition cost,

Speaker #3: 21(e) of the Securities Exchange Act of 1934.

Speaker #3: year. This represents a premium to our competitor's WAC pricing. We believe this WAC pricing.

Speaker #3: All statements other than statements of

Speaker #2: All statements other than statements of historical fact are forward-looking statements, and are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed in any forward-looking statements.

Vincent Anzalone: All statements other than statements of historical fact are forward-looking statements and are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed in any forward-looking statements. For further details concerning these risks and uncertainties, please refer to our SEC filings, including our most recent annual report on Form 10-K and our quarterly reports on Form 10-Q. I'd now like to turn the call over to Chris.

Speaker #3: statements, and are subject to numerous risks

Speaker #3: is appropriate given that clinical We believe this is

Speaker #3: and uncertainties, that could

Speaker #3: cause actual

Speaker #3: intermonitorably superior product in terms of TG reduction, safety profile, and convenience. As part

Speaker #3: results to differ materially from those expressed in

Speaker #3: any forward-looking

Speaker #3: statements. For further details, concerning these risks and uncertainties, please refer

Speaker #3: of the One REDEMPLO Unified

Speaker #2: For further details, concerning these risks and uncertainties, please refer to our SEC filings including our most recent annual report on Form 10-K and our quarterly reports on Form 10-Q.

Speaker #3: Pricing Model, this price is intended to remain productive.

Speaker #3: consistent across FTS and

Speaker #3: to our SEC filings, including our most recent annual report on Form 10-K and our quarterly reports on Form 10-Q. I'd now like to turn the call over to Chris.

Speaker #3: SHCG, if that indication is approved.

Speaker #3: strategy as potentially simplifying payer

Speaker #3: contracting and eliminating pricing

Speaker #2: I'd now like to turn the call over to Chris.

Speaker #3: complexity that could complicate future

Speaker #4: Thanks, Vince. Good afternoon, everyone, and thank you for joining us today. During the fiscal second quarter, in the period since our last earnings call, we have continued to execute well against our commercial,

Speaker #3: Formulary negotiations. Administration, the Chinese National Medical. The response from payers to this strategy has been

Speaker #3: Thanks, Vince. Good afternoon, everyone, and thank you for joining us today. During the fiscal second quarter, in the period since our last earnings call, we have continued to execute well against our commercial, R&D, and corporate goals.

Christopher Anzalone: Thanks, Vince. Good afternoon, everyone, and thank you for joining us today. During the fiscal second quarter, in 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're commercial. We have a clear line of sight to expand our commercial opportunities and footprints. Our pipeline is larger than ever. Our discovery capabilities are broader than ever. Our balance sheet is stronger than ever. This is an 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'll recall, the FDA approved REDEMPLO in November 2025 as an adjunct to diet to reduce triglycerides in adults with FCS.

Speaker #3: positive and our interactions to date have been

Speaker #3: productive. European Medicines Agency's Committee

Speaker #4: R&D, and corporate filings, including our most recent annual goals. Arrowhead is now on the strongest

Speaker #3: REDEMPLO in patients with

Speaker #3: genetically confirmed and clinically

Speaker #3: Arrowhead is now on the strongest footing of our history. Your 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.

Speaker #3: defined FTS. We received achieved by our global regulatory team in

Speaker #4: Your

Speaker #3: approvals from the Australian Therapeutic Goods in a very short period.

Speaker #4: sight to expand our commercial opportunities

Speaker #3: Administration, the Chinese National

Speaker #4: Our pipeline is larger than ever. Our discovery

Speaker #3: Medical Products Administration, and FTS and the value that REDEMPLO offers to Health Canada. In addition,

Speaker #4: capabilities are broader than ever. And

Speaker #4: our balance sheet is stronger than

Speaker #3: the European Medicines patients.

Speaker #3: Agency's Committee for Medicinal Products

Speaker #4: This is a historic time for our company. We are uniquely positioned

Speaker #3: for Human Use adopted a positive

Speaker #3: This is a historic time for our company. We are uniquely positioned to deliver important medicines to the patients who need them and to create substantial value for our shareholders.

Speaker #3: opinion recommending the approval of Ending a marketing authorization decision

Speaker #3: REDEMPLO. This is an impressive from the European Commission, we expect to

Speaker #4: patients who need them, and to create

Speaker #3: result achieved by our global

Speaker #4: substantial value for our

Speaker #4: shareholders. line of sight to expand our commercial Let's talk about some of our recent progress and begin with commercial. As you

Speaker #3: regulatory team in a very short period. And EU countries, and likely in the UK as well, further reflects the strength of our clinical data and

Speaker #3: 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 FTS.

Speaker #3: FTS and the value that

Speaker #3: REDEMPLO offers to patients. Sanofi.

Speaker #4: REDEMPLO in November 2025 as an adjunct to diet to reduce triglycerides in adults with FTS. FTS is a severe rare disease with an estimated 6,500 people in the US living with genetic or clinical FTS, characterized by TG levels that can be 10 to 100 times higher than normal.

Speaker #3: REDEMPLO will be available later this year in

Speaker #3: Canada and will anticipate it will be marketed has performed extremely well and has

Speaker #3: ARROWHEAD. Pending a marketing authorization

Speaker #3: FTS is a severe rare disease with an estimated 6,500 people in the U.S. living with genetic or clinical FTS, characterized by TG levels that can be 10 to 100 times higher than normal.

Christopher Anzalone: FCS is a severe, rare disease with an estimated 65 million people in the US living with genetic or clinical FCS, characterized by TG levels that can be 10 to 100 times higher than normal. This leads to a substantially increased risk of developing acute, recurring, and potentially fatal pancreatitis. As we reported last quarter, the US 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. More than 400 prescriptions have been written since launch, and more than 10% of these have been for patients switching from our competitor's 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.

Speaker #3: decision from the European Commission, we

Speaker #3: select EU countries and likely in the

Speaker #3: China, REDEMPLO will be marketed by

Speaker #4: This leads to a substantially increased risk of developing acute recurrent and

Speaker #3: 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.

Speaker #3: Sanofi. In addition to our

Speaker #4: potentially fatal pancreatitis. As we reported last

Speaker #3: regulatory team, the rest of the R&D

Speaker #3: organization has performed extremely well and has made progress in the broader

Speaker #3: portfolio. Our drive to expand our

Speaker #3: platforms to in order to

Speaker #3: we can address continues, even as

Speaker #4: week. Greater than 400 prescriptions have been written since launch, and more than 10% of shareholders. these have been for patients switching from our

Speaker #3: entity. During the recent period, we have made rapid progress across the pipeline, including programs targeting the 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 two genes with a single molecule.

Speaker #4: fully adjudicated with payers, before becoming paid claims, but we offer a robust quick-start program

Speaker #3: 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 FTS patients in the interim.

Speaker #4: interim. The volume of physicians writing prescriptions and the number of

Speaker #3: We believe the depth and breadth of our clinical pipeline

Christopher Anzalone: 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 US full sale 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 FHCG 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. The response from payers to this strategy has been positive, and our interactions to date have been productive.

Speaker #3: 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.

Speaker #3: is unmatched. And we expect to SHAST3 and 4 studies of

Speaker #4: exceed our initial expectations. With respect to pricing, we updated REDEMPLO's US wholesale acquisition cost, or WAC, to $45,000 per patient per year. This

Speaker #3: innovation. Importantly, many of these

Speaker #3: programs will have clinical

Speaker #3: readouts, this year, so investors and others may

Speaker #3: 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 intermonitorably superior product in terms of TG reduction, safety profile, and convenience.

Speaker #3: start to properly value the broader anticipated supplemental NDA

Speaker #3: pipeline. As we look or SNDA, as we seek to expand

Speaker #3: to near-term clinical data releases, the population of patients we can treat with

Speaker #3: we anticipate four important

Speaker #4: appropriate, given that clinical data suggests we have a clearly intermonitorably 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 FTS and SHCG, if that indication is approved.

Speaker #3: III SHAST3 and 4 studies of

Speaker #3: patients should be ready for top-line data release in Q3. This

Speaker #2: on the Yosemite phase three study of zodaceran, 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.

Speaker #3: is an important readout that will drive our

Speaker #3: anticipated supplemental early data from the ongoing phase one-two

Speaker #3: As part of the One Redemplo Unified Pricing Model, this price is intended to remain consistent across FTS and SHCG, if that indication is approved.

Speaker #3: NDA or SNDA as we seek study of ARROWDIMER PA in

Speaker #3: to expand the population of patients we can patients with mixed hyperlipidemia

Speaker #3: treat with losastra.

Speaker #3: We expect to continue to see a favorable the world's first clinical data of a

Speaker #4: We continue to see this strategy as potentially simplifying payer

Speaker #3: safety profile and substantial single RNAi molecule designed to

Speaker #3: We continue to see this strategy as potentially simplifying payer contracting and eliminating pricing complexity that could complicate future formulary negotiations. The response from payers to this strategy has been positive, and our interactions to date have been productive.

Speaker #3: reduction in TGs, and we are

Speaker #2: Zodaceran 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 two-to-one to receive five doses of 200 milligrams of zodaceran or placebo.

Speaker #3: in acute pancreatitis

Speaker #4: negotiations. The response data suggests we have a clearly from payers to this strategy has been positive,

Speaker #3: risk. Second, we expect to ApoC3 and therefore reductions in have early data from the ongoing Phase

Speaker #4: and our interactions to date have been

Speaker #3: I/II study of ARROWDIMER

Speaker #4: Beyond the US, we secure positive regulatory

Speaker #3: PA in patients with mixed therapy for the roughly 20 million

Speaker #3: Beyond the U.S., we secure positive regulatory action in four additional geographies for Redemplo in patients with genetically confirmed and clinically defined FTS. We received approvals from the Australian Therapeutic Goods Administration, the Chinese National Medical Product Administration, and Health Canada.

Christopher Anzalone: Beyond the US, we secure positive regulatory action in four additional geographies for REDEMPLO in patients with genetically confirmed and clinically defined FCS. We received approvals from the Australian Therapeutic Goods Administration, the 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 UK as well.

Speaker #3: Hyperlipidemia in Q3. We, people in the US living with mixed—

Speaker #4: action in four additional geographies for

Speaker #4: REDEMPLO in patients with genetically confirmed and clinically defined

Speaker #3: believe this will be the world's first clinical data

Speaker #3: of a single RNAi molecule broadly, the data could provide

Speaker #4: We received approvals from the Australian Therapeutic Goods

Speaker #3: of two proteins. If we

Speaker #3: see good reduction of growing DIMER platform and

Speaker #2: 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.

Speaker #3: PCSK9 and APOC3 and therefore reductions pipeline.

Speaker #4: Product Administration, and Health Canada. In addition, the

Speaker #3: in LDL cholesterol and TGs, we could have a very powerful

Speaker #3: 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.

Speaker #4: for Medicinal Products for Human

Speaker #3: and unique therapy for the roughly 20 2027.

Speaker #3: million people in the US living

Speaker #4: Use adopted a positive regulatory action in four additional geographies for opinion recommending the approval of

Speaker #3: with mixed hyperlipidemia. study of ARROWMAP T around the

Speaker #4: REDEMPLO.

Speaker #3: More broadly, the data could provide end of Q3 or early

Speaker #3: initial clinical proof of concept for our

Speaker #2: The last program within cardiometabolic is aerodimer PA. The first dual-functional siRNA designed to silence the expression of two genes with a single RNAi molecule.

Speaker #4: And further reflects the strength of our clinical data and

Speaker #3: growing DIMER platform and our CNS platform designed to

Speaker #3: And further reflects the strength of our clinical data and FTS 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.

Speaker #3: pipeline. Expect to see deliver RNAi molecules to the brain

Speaker #3: additional dual-functional DIMERs in the clinic in

Speaker #4: REDEMPLO will be

Speaker #3: 2027. Third, we expect to

Speaker #4: available later this year in Canada, and we anticipate it will be marketed independently by ARROWHEAD.

Speaker #3: have early data from the ongoing Phase T targets the tau protein, which is I/II study of ARROWMAP T

Speaker #2: Aerodimer 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 one 2A placebo-controlled dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on LDL cholesterol and triglycerides, using single-dose aerodimer PA in part one and multiple doses in part two in up to 78 adults with mixed hyperlipidemia.

Speaker #3: Pending a marketing authorization decision from the European Commission, we expect to launch Redemplo later this year and select EU countries and likely in the U.K.

Speaker #3: around the end of Q3 or early

Speaker #3: Q4. As you recall, this is our

Speaker #4: launch REDEMPLO later this year in select

Speaker #3: first candidate positive early data could be substantially

Speaker #3: using our CNS platform designed to

Speaker #4: well. In Greater China, REDEMPLO will be marketed by

Speaker #3: 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.

Speaker #3: deliver RNAi molecules to the leap forward in treating tau opposites and, more

Christopher Anzalone: 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.

Speaker #3: brain via simple subcutaneous, broadly open the door to using

Speaker #4: In addition to our regulatory team, the rest of the R&D organization

Speaker #3: administration. Our MAP T

Speaker #3: ARROWMAP T targets the tau

Speaker #4: made progress in the broader portfolio. Our drive to expand our

Speaker #3: protein, which is increasingly validated for ARROWMAP T data are

Speaker #4: platforms in order to increase the

Speaker #3: the potential treatments of Alzheimer's and

Speaker #3: Our drive to expand our platforms to in order to increase the number and types of diseases we can address continues, even as we grow as a commercial entity.

Speaker #4: number and types of diseases we can address continues, even as we grow

Speaker #3: other tauopathies. We believe

Speaker #3: that positive early data could be of

Speaker #3: substantially disruptive; it could represent

Speaker #4: as a commercial entity.

Speaker #3: tauopathies and, more broadly, open the door to

Speaker #4: rapid progress across the pipeline,

Speaker #3: 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 two genes with a single molecule.

Speaker #4: including programs targeting genes expressed

Speaker #3: using RNAi to treat a broad range second half of the year.

Speaker #2: Enrollment in the study has been rapid, and we are on schedule to have sufficient data to provide the first clinical readouts in Q3 of this year.

Speaker #4: in liver, skeletal

Speaker #3: of conditions from neurodegenerative

Speaker #4: muscle, adipose,

Speaker #3: disorders to obesity. If present additional data at various

Speaker #3: Early ARROWMAP T data are conferences and launch a phase two—encouraging, expect a substantial expansion.

Speaker #4: first dual-functional siRNA designed to

Speaker #3: of our CNS pipeline beginning at

Speaker #4: silence the expression of two genes with a single molecule. We believe the

Speaker #2: 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.

Speaker #3: the end of from the ongoing phase one-two 2026. Fourth, we expect to

Speaker #3: 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.

Christopher Anzalone: 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 four 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.

Speaker #4: 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.

Speaker #3: ARROWINHBE and ARROWL7 throughout the second half of the year.

Speaker #2: So we're eager to have a first clinical readout to start moving ahead with later studies. It's supported by initial data. Lastly, I'd like to give an update on the status of the ARROWMAP-T first in human study.

Speaker #3: To present additional data at various development portfolio, and we also entered conferences and launched a Phase II study. For ARROWL7, we expect to provide additional data from the ongoing Phase I/II study.

Speaker #4: As we look to near-term clinical data releases, we anticipate four important events. First, the phase three

Speaker #3: As we look to near-term clinical data releases, we anticipate four important events. First, the Phase III SHASTA-3 and 4 studies of losastra and NSHTG patients should be ready for top-line data release in Q3.

Speaker #3: We see these as potentially important therapies for metabolic

Speaker #4: Losastran in SHCG patients should be ready for top-line data release.

Speaker #2: ARROWMAP-T is being developed as a potential treatment for myopathies, 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.

Speaker #3: disorders and represent our first

Speaker #3: steps into obesity and a program that achieves clinical proof of

Speaker #3: MASH. We expect to have additional candidates in

Speaker #4: in Q3.

Speaker #4: important readout that will drive our

Speaker #3: this space by the end of the year and forward.

Speaker #3: 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 losastra.

Speaker #3: into

Speaker #3: portfolio management, ARROWHEAD

Speaker #3: took important steps to ensure that we Let's talk about the steps we

Speaker #4: losastran. We expect

Speaker #4: to continue to see a favorable safety profile and substantial reduction in

Speaker #3: are properly funded to advance our took.

Speaker #2: And as part of a group of neurodegenerative diseases called tauopathies, that are marked by abnormal tau accumulation and formation of tau tangles in neurons.

Speaker #3: We expect it 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.

Speaker #3: commercial and development portfolio and we

Speaker #3: commercial and development portfolio and we also entered into license multiple programs toward

Speaker #4: TGs, and we are cautiously optimistic that we could see an improvement in acute

Speaker #3: agreements for a program that achieves clinical proof of commercialization and potentially through multiple

Speaker #4: pancreatitis risk. Second, we expect to have

Speaker #3: forward. This is key to

Speaker #2: Tau-related pathology may be a critical driver of neurodegeneration and targeting tau as a promising strategy that potentially slow or stop cognitive and functional decline.

Speaker #3: Second, we expect to have early data from the ongoing Phase I/II study of aerodimer 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 two proteins.

Speaker #3: ARROWHEAD's strategy since we are extraordinarily

Christopher Anzalone: 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 two proteins. If we see good reduction of PCSK9 and APOC3, and therefore reductions in LDL cholesterol and TGs, we could have a very powerful and unique therapy for the roughly 20 million people in the US living with mixed hyperlipidemia. More broadly, the data could provide initial clinical proof of concept for our growing dimer platform and pipeline. 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.

Speaker #3: productive in discovery and early development conducted.

Speaker #3: but cannot commercialize everything

Speaker #3: independently. Let's talk about the steps we

Speaker #4: in Q3.

Speaker #3: took. First, we senior notes and $230

Speaker #4: simultaneously silence the expression of

Speaker #2: ARROWMAP-T 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.

Speaker #3: commercialization and potentially through

Speaker #4: two proteins. If we see good reduction of PCSK9 and

Speaker #3: multiple independent and partner confidence in our portfolio and our ability

Speaker #3: If we see good reduction of PCSK9 and ApoC3 and therefore reductions in LDL cholesterol and TGs, we could have a very powerful and unique therapy for the roughly 20 million people in the U.S.

Speaker #3: launches. During the quarter, we completed the to continue to build largest fundraising ARROWHEAD has ever

Speaker #4: LDL cholesterol and TGs, we could have a very powerful and unique

Speaker #3: conducted. We closed concurrent public

Speaker #3: offerings of $700 agreement with Madrigal Pharmaceuticals for million of 0% coupon

Speaker #4: hyperlipidemia. More

Speaker #3: convertible senior notes and

Speaker #3: living with mixed hyperlipidemia. More broadly, the data could provide additional initial clinical proof of concept for our growing dimer platform and pipeline. Expect to see additional dual-functional dimers in the clinic in 2027.

Speaker #3: $230 million of common

Speaker #3: stock. Both offerings were MASH patients.

Speaker #4: additional initial clinical proof of concept for our

Speaker #2: 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.

Speaker #3: several times oversubscribed reflecting

Speaker #3: investor confidence in our portfolio and

Speaker #4: Expect to see additional dual-functional DIMERs in the clinic in

Speaker #3: value. Second, and just this

Speaker #3: license agreement with Madrigal Pharmaceuticals

Speaker #4: Third, we expect to have early data from the ongoing phase one-two

Speaker #3: Third, we expect to have early data from the ongoing Phase I/II study of ARROWMapT 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.

Speaker #3: for ARROW PMPLA3,

Speaker #3: ARROWHEAD's clinical stage program designed

Speaker #2: In December 2025, we dosed the first subjects in a phase one two clinical trial of ARROWMAP-T. This study is a placebo-controlled dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARROWMAP-T 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.

Speaker #4: Q4. As you recall, this is our first candidate using

Speaker #3: of MASH patients.

Speaker #3: Under the terms of the agreement, Madrigal will pay partner to advance ARROW

Christopher Anzalone: As you recall, this is our first candidate using our CNS platform designed to deliver RNAi molecules to the brain via simple subcutaneous administration. ARO-MAPT targets the tau protein, which is increasingly validated for the potential treatments of Alzheimer's and other tauopathies. We believe that positive early data could be substantially disruptive. It could represent a great leap 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. If early ARO-MAPT data are encouraging, 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.

Speaker #3: a $25 million upfront payment to PMPLA3 into phase two studies and toward

Speaker #3: ARROWHEAD. ARROWHEAD is also potential commercialization.

Speaker #3: eligible to receive development, regulatory, and

Speaker #4: via simple subcutaneous

Speaker #4: administration. Our MAP T targets sorry, ARROWMAP

Speaker #3: sales milestone payments of up to ARROWHEAD's disciplined business development

Speaker #3: $975

Speaker #3: Our MAPT targets sorry, ARROWMapT targets the tau protein, which is increasingly validated for the potential treatments of Alzheimer's and other tauopathies. We believe that positive early data could be substantially disruptive.

Speaker #3: million. ARROWHEAD is further eligible to receive high-potential clinically validated

Speaker #4: increasingly validated for the potential treatments of Alzheimer's and other tau

Speaker #3: tiered royalties up to $19 programs with leading

Speaker #4: opposites. We believe that

Speaker #3: the MASH space makes it a natural and

Speaker #3: attractive partner to advance ARROW Andy?

Speaker #4: disruptive. It could represent a great

Speaker #2: In part one A of the study, healthy subjects will receive one or three weekly doses of ARROWMAP-T or placebo by subcutaneous injection. In parts one B and part two, healthy volunteers and Alzheimer's disease patients, respectively, will receive multiple escalating doses of ARROWMAP-T or placebo.

Speaker #3: toward potential

Speaker #3: It could represent a great leap 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.

Speaker #3: commercialization. This transaction with Madrigal the FDA approval of REDEMPLO on

Speaker #3: underscores ARROWHEAD's disciplined business development November 18, 2025,

Speaker #4: RNAi to treat a broad range of

Speaker #4: conditions from neurodegenerative disorders to obesity. If early

Speaker #3: strategy demonstrating our ability to partner high-potential clinically

Speaker #3: validated programs with leading

Speaker #3: If early ARROWMapT data are encouraging, expect a substantial expansion of our CNS pipeline beginning at the end of 2026. Fourth, we expect to provide clinical updates on ARROWi and HPE and ARROWL7 throughout the second half of the year.

Speaker #4: encouraging, expect a substantial expansion of our

Speaker #3: organizations. With that overview, I'd prescription and patient dynamics,

Speaker #3: Davis. Andy?

Speaker #4: 2026. Fourth, we expect to provide

Speaker #1: Thank you, Chris,

Speaker #1: and good afternoon, everyone. It has now been approximately five and a half months since the FDA approval. Pricing strategy, commercial infrastructure expansion, and our international and SHTG outlook.

Speaker #2: 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.

Speaker #4: clinical updates on ARROW-INHBE and ARROW-L7 throughout the

Speaker #4: Regarding ARROWINHBE, we plan to

Speaker #3: Regarding ARROWi and HPE, we plan to present additional data at various conferences and launch a Phase II study. For ARROWL7, we expect to provide additional data from the ongoing Phase I/II study.

Speaker #4: study. For ARROWL7, we expect to provide additional data

Speaker #2: 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.

Christopher Anzalone: 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 MASH. 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 is 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.

Speaker #4: study. We see these as potentially important therapies for metabolic disorders and represent our first steps into obesity and MASH. We expect to have additional candidates in this space by the end of the year and into 2027.

Speaker #3: We see these as potentially important therapies for metabolic disorders and represent our first steps into obesity and MASH. We expect to have additional candidates in this space by the end of the year and into 2027.

Speaker #1: Thank you, James, and good afternoon, everyone. As we reported today, net loss for the quarter ended March 31, 2026, was 132.7 million dollars, or a loss of 93 cents per share.

Speaker #4: Moving on to financial and portfolio management, ARROWIN took important steps to ensure that we are properly funded to advance our commercial and

Speaker #3: Moving on to financial and portfolio management, ARROW took important steps to ensure that we are properly funded to advance our commercial and development portfolio, and we also entered into license agreements for a program that achieves clinical proof of concept but is not one that we wish to take forward.

Speaker #1: Based on 142.4 million fully diluted weighted average shares outstanding. This compares to net income of 370.4 million dollars, or $2.75 per share, for the quarter ended March 31, 2025.

Speaker #4: into a license agreement for a

Speaker #4: This is key to ARROWIN's

Speaker #3: This is key to ARROW'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.

Speaker #4: in discovery and early development but cannot commercialize everything independently.

Speaker #1: 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 dollars in revenue, solely related to disruptive transaction that was executed at that time.

Speaker #4: First, we dramatically strengthened our balance sheets, allowing us to push

Speaker #3: First, we dramatically strengthened our balance sheets, 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.

Christopher Anzalone: 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, 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 MASH patients. Under the terms of the agreement, Madrigal will pay a $25 million upfront payment to Arrowhead.

Speaker #4: independent and partner launches. During the quarter, we completed the largest

Speaker #4: fundraising ARROWHEAD has ever

Speaker #1: Revenue for this quarter totaled 74 million dollars, driven primarily by our licensing collaboration agreements with Sarepta and with Novartis. Of this amount, approximately 42 million related to the Sarepta collaboration.

Speaker #4: We closed concurrent public offerings of $700 million.

Speaker #3: 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.

Speaker #4: of 0% coupon convertible

Speaker #4: million of common stock. Both

Speaker #4: offerings were several times push multiple programs toward oversubscribed reflecting investor

Speaker #1: 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 clinical supply agreement.

Speaker #4: value. Second, and just this week, we announced an exclusive worldwide license

Speaker #3: Second, and just this week, we announced an exclusive worldwide license agreement with Madrigal Pharmaceuticals for ARROW PMPLA3, ARROWhead's clinical stage program designed to treat a genetically defined population of MASH patients.

Speaker #4: ARROW PMPLA3, ARROWHEAD's clinical stage program designed to

Speaker #4: treat a genetically defined population of

Speaker #1: In addition, we recognized 20 million of the 200 million dollar upfront payment received from Novartis in October bringing year-to-date recognition of Novartis upfront to 54 million.

Speaker #4: Under the terms of the agreement, Madrigal will pay a

Speaker #3: Under the terms of the agreement, Madrigal will pay a $25 million upfront payment to ARROWhead. ARROWhead has also eligible to receive development regulatory and sales milestone payments of up to $975 million.

Speaker #4: ARROWHEAD. ARROWHEAD is also eligible to

Christopher Anzalone: 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 up to mid-teens. Madrigal's leadership in the MASH space makes it a natural and attractive partner to advance ARO-PNPLA3 into phase II studies and toward potential commercialization. This transaction with Madrigal underscores Arrowhead's disciplined business development strategy, demonstrating our ability to partner high-potential, clinically validated programs with leading organizations. With that overview, I'd now like to turn the call over to Andy Davis. Andy?

Speaker #4: milestone payments of up to

Speaker #1: With the remaining 146 million dollars to be deferred over time, as we fulfill our preclinical obligation. We also recorded 11 million related to the asset purchase agreements between Sanofi and Vicerna to develop and commercialize investigational possession in Greater China.

Speaker #4: Arrowhead is further eligible to receive tiered

Speaker #3: ARROWhead is further eligible to receive tiered royalties up to $19 million. Madrigal's leadership in the MASH space makes it a natural and attractive partner to advance ARROW PMPLA3 into Phase II studies and toward potential commercialization.

Speaker #4: royalties up to $19

Speaker #4: million. Madrigal's leadership in the MASH space makes it a natural and attractive

Speaker #4: This

Speaker #1: Vicerna, as you know, is our majority-owned subsidiary with operations in China. And the amount recognized was almost entirely due to the January approval of FCS in that region by the Chinese National Medical Products Administration.

Speaker #3: This transaction with Madrigal underscores ARROWhead's disciplined business development strategy demonstrating our ability to partner high-potential clinically validated programs with leading organizations. With that overview, I now like to turn the call over to Andy Davis.

Speaker #4: strategy, demonstrating our ability to partner

Speaker #4: organizations. With that overview, I'd now like to turn the call over to Andy Davis.

Speaker #5: Thank you, Chris, and good

Speaker #1: 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.

Speaker #3: Andy?

Speaker #5: afternoon, everyone. It has now PMPLA3 into Phase II studies and been approximately five and a half months since

Speaker #5: Thank you, Chris, and good afternoon, everyone. It has now been approximately five and a half months since the FDA approval of Redemplo on November 18, 2025, and we continue to be very pleased with the trajectory of the launch.

Andy Davis: Thank you, Chris, and good afternoon, everyone. It has now been approximately five and a half months since the FDA approval of REDEMPLO on 18 November 2025, and we continue to be very pleased with the trajectory of the launch. Today, I would like to cover five areas: prescription and patient dynamics, payer coverage developments, 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 Q2, ending 31 March 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 four weeks alone. The awareness and conviction driving this prescription growth are encouraging.

Speaker #5: and we continue to be very pleased with the

Speaker #5: trajectory of the launch. Today, I would like to cover five areas:

Speaker #1: 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 dollars for the quarter.

Speaker #5: Today, I would like to cover five areas: prescription and patient dynamics, payer coverage developments, pricing strategy, commercial infrastructure expansion, and our international NSHTG outlook.

Speaker #5: payer coverage developments, pricing strategy, commercial

Speaker #5: infrastructure expansion, and our international and SHTG outlook. Let's start with prescription.

Speaker #1: 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.

Speaker #5: Let's start with prescription and patient dynamics. Redemplo's launch continues to build strong and consistent momentum. Through the fiscal second quarter and the March 31, 2026, we have seen prescriptions accelerating week over week.

Speaker #1: Turning now to expenses, total operating expenses for the quarter were approximately 250 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.

Speaker #5: 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 four weeks alone.

Speaker #5: 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.

Speaker #1: This increase is 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 three registration of studies for prazosin and SHTG, as well as our early-stage pipeline programs including the Dimer and MAP-T.

Andy Davis: 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. REDEMPLO is perceived strongest on the efficacy outcomes FCS 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. Refill 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.

Speaker #5: Nearly all Redemplo prescribers surveyed report being satisfied or highly satisfied with the product, and Redemplo is perceived strongest on the efficacy outcomes FCS patients care about most.

Speaker #5: 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.

The awareness and conviction driving this prescription growth are encouraging.

Speaker #1: Fiscal year to date, almost two-thirds of the clinical trial spend can be attributed to our prazosin phase three studies. As James already mentioned, the registration of SHTG studies for prazosin should readout in the summer, and clinical trial spend for these programs should thereafter moderate accordingly.

Redeemable awareness among the prescribers who matter most has increased meaningfully.

Speaker #5: Switch patients largely account for the remainder. Patient persistence data is equally encouraging. Refill activity is accelerating meaningfully and important early validation of both clinical effectiveness and patient satisfaction with Redemplo's once-quarterly dosing profile.

Critically, this awareness is translated into conviction. Nearly all Redemption will prescribe or survey report being satisfied or highly satisfied with the product, and Redemption flow is perceived strongest on the efficacy outcomes FCS patients care about most: triglyceride reduction and acute pancreatitis risk reduction.

Speaker #1: SG&A expenses increased year over year compared to the prior year's second fiscal quarter, driven primarily by ongoing investments to support the commercialization of Redemplo.

Speaker #1: 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.

Speaker #5: 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.

The patient makes continues to reflect what we expected. Approximately 85% of prescriptions are from patients naive to the apocalyptic free class a strong signal. That Physicians are identifying and treating SDS patients who have never had access to an effective therapy

Andy Davis: 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. 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 US 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.

Twist patients largely account for the remainder.

Speaker #5: 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 accents, we are making meaningful and consistent progress.

Speaker #1: And we ultimately expect to leverage these same capabilities for the advancement of prazosin for the treatment of HOFH. Turning to the balance sheet, cash and investments on hand total nearly 1.8 billion as of March 31, 2026.

Patient persistence data is equally encouraging refill activity is accelerating meaningful, even important early, validation of both clinical. Effectiveness and patient satisfaction for dental is 1's. Quarterly dosing profile

Speaker #5: Our market access team has been actively engaged with the largest payers in the country, covering the vast majority of US lines. To support continued patient access.

Speaker #5: 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.

Speaker #1: Common shares outstanding at quarter-end were 140.6 million. To provide a little cover, in this quarter alone, we brought in over $1 billion including approximately 850 million net from our January financing transactions inclusive of a concurrent alternative 0% convertible senior notes and common stock, along with the associated capped call transactions.

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 constantly in the handful of high, volume sensors and this gives us confidence in the durability of the prescription growth trajectory.

Journey to pay your accents.

Speaker #5: 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.

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 us lives to support continued patient access.

Andy Davis: 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 FCS 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.

These discussions are proceeding as expected. And in some cases have already led to Redemption close to improved coverage

Speaker #1: Other notable inflows in the quarter include the 200 million received from Sarepta upon achieving the second Tier 1 program milestone, as well as a 50 million anniversary payment under the Sarepta long-term collaboration agreement.

Speaker #5: This is critical for ensuring that all appropriate Redemplo patients can access treatment. Because a meaningful proportion of real-world FCS patients are clinically diagnosed, rather than genetically confirmed.

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

Speaker #5: 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.

Speaker #1: 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.

It covers policies taking shape across major, payers reflect both genetic testing and clinical criteria as valid groups to diagnosis.

This is critical for ensuring that all appropriate. Redemptive patients can access treatment

Speaker #5: 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.

Speaker #1: With that brief overview, I will now turn the call back to Chris.

Because a meaningful proportion of real-world SDS patients are clinically diagnosed rather than genetically confirmed, policies that require genetic confirmation as a prerequisite would create an unnecessary and inappropriate barrier.

Speaker #5: We have always believed that Redemplo's clinical profile is best in class and the $45,000 per year price point reflects a premium value supported by the clinical evidence.

Speaker #2: Thanks, Dan. As we build out our commercial team and focus on efficiently bringing Redemplo to the 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.

Andy Davis: We have always believed that REDEMPLO's clinical profile is best in class, and the $45,000 per year price point reflects a 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, 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 three markets are currently in pre-launch phase as we work through the pricing and reimbursement frameworks in each country.

As Chris mentioned, we have made a proactive decision to reduce the list price of redemption. Loads of 45,000 dollars per patient per year.

Speaker #5: 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.

Speaker #2: Our business has become more complex as we grow in all these areas, but 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.

This decision reflects our commitment to optimizing market access for FCS patients. It is consistent with our beliefs that a competitive and rational price point accelerates formulary decisions and reduces friction in the prior authorization process.

Speaker #5: 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.

We have always believed that redemp clinical profile is best in class and the 45,000 per year. Price point. Reflects a premium value supported by the clinical evidence.

Speaker #2: Here are just a few of the events we are tracking. Just a three, just a four, and year three, which is a suite of phase three clinical studies designed to support an SNDA for Redemplo in patients with SHTG, is on schedule for completion and top-line readout in Q3.

Speaker #5: On international expansion, Redemplo received regulatory approval in both Canada and China in January, and most recently in Australia last month. All three markets are currently in pre-launch phase as we work through the pricing and reimbursement frameworks in each country.

That the fds launched performing ahead of our expectations and with potential expansion into sxd on the horizon. We are making deliberate and sequenced Investments to scale our commercial infrastructure.

Speaker #2: The first clinical readout of Arrow Dimer PA targeting both PCSK9 and APOC3 for LDL and TG lowering is also expected in Q3. The first clinical readout for Arrow MAP-T is expected around the end of Q3 or early Q4.

Speaker #5: We look forward to providing updates on those timelines 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.

Andy Davis: We look forward to providing updates on those timelines as they develop. 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. We anticipate an EMA approval decision in the June to July timeframe. 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. 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.

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 SDS accessible population and also the future satg opportunity as it unfolds in the future.

Speaker #2: This 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.

Speaker #5: Consequently, we anticipate an EMA approval decision in the June to July timeframe 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.

On International expansion, Redemption received regulatory approval, in both Canada, and China in January. And most recently in Australia last month, all 3 markets are currently in pre-launch Phase as we work through the pricing and reimbursement Frameworks in each country. We look forward to providing updates on those timelines that they developed.

Speaker #2: Additional Arrow INHPE and Arrow 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 quick tears appetite and with liver fat reductions as monotherapy or in combination with tears appetite.

Also last month, C hmpps, the committee for medicinal products for human use recommended EU marketing authorization for Redemption, blue and Europe for SDS without requiring genetic confirmation.

Speaker #5: 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.

Consequently, we anticipate an EMA approval decision in the June to July time frame.

Speaker #5: Finally, I want to comment on the FHTG program, which represents the most significant near-term value add listed for anabolic franchise. We are approaching what we expect to be a highly meaningful series of milestones.

Speaker #2: As James mentioned, we are planning to webcast three presentations as part of our summer series of R&D webinars, to go over cardiometabolic broadly, obesity, and Arrow MAP-T.

We intend the commercialized Redemption flow directly in Europe, supported by contracted infrastructure, which encompasses market access strategy, account management, appointments, Medical Science Liaison support, and broader stakeholder engagements, including medical congresses and patient advocacy group engagements.

Speaker #5: Hotline results from Chapter 3 and Chapter 4 are two registrational Phase 3 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.

Speaker #2: These can serve as a review of the programs and results to date and as a primer to the potentially important readouts coming up later this year.

Andy Davis: 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 expect to file an sNDA with the FDA before the end of 2026, with an anticipated regulatory approval based on an expected standard review timeline targeted in H2 2027. Additional regulatory filings in other jurisdictions are planned to follow thereafter.

Decision.

Speaker #2: Thank you for joining us today, and I would now like to open the call to your questions.

Finally, I want to comment on the shtg program, which represents the most significant near-term value Catalyst for the cardio metabolic franchise.

Speaker #3: Thank you. At this time, we will now conduct the question-and-answer session. As a reminder to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced.

Speaker #5: 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.

Speaker #5: 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 timeline targeted in second half of 2027.

Speaker #3: To withdraw your question, please press star 11 again. Please note that each analyst is permitted to ask one question. Should you have a follow-up question, you will need to get back in queue.

We are approaching what we expect to be a highly meaningful series of Milestones. Hotline results. From Shasta, 3, and Shasta, 4 or 2 registration phase 3, studies, and severe hypertriglyceridemia.

Speaker #5: Additional regulatory filings and other jurisdictions are planned to follow thereafter. The FHTG 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.

Speaker #3: Please stand by while we compile the Q&A roster. Our first question comes from the line of Edward Tentoff from Piper Sandler. Your line is now open.

Andy Davis: 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 intents 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.

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

Speaker #4: Great. Thank you, and thanks for all the detail in the update today. My question really has to do with looking at the upcoming SH severe hypertriglyceridemia readouts.

With any respect the file, an SDA with the FDA before the end of 2026 with an anticipated regulatory approval, based on an expected standard review. Timeline targeted in second, half of 2027,

Speaker #5: 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.

Additional regulatory filings, and other jurisdictions are planning to follow thereafter.

Speaker #4: When it comes to pancreatitis as a secondary, is the plan to pool FASTA4 3 and 4, and what are sort of the assumptions around pancreatitis?

The shc opportunity represents a patient population that is substantially larger than fds with over 1 million, high-risk patients in the United States alone.

The commercial infrastructure Investments. We are making for SCS. Today are also designed with that launched in line.

Speaker #5: With that, I'll turn the call over to James Hamilton to discuss the broader R&D portfolio.

Speaker #4: Thank you.

In summary the redemptor launches progressing well and continues to exceed our expectations across prescription volume patient Dynamics, and payer access.

Speaker #6: 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.

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 three 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 MIRROR III, designed to support supplemental NDA filings to expand the REDEMPLO label beyond genetic and clinical FCS in the patients with SHTG.

Speaker #2: Yeah, it's Ed. Thanks for the question. This is James. Yeah, you've got that right. The plan is to pool both of those studies: FASTA 3 and 4, and we'll analyze do a meta-analysis of those two studies to look at pancreatitis event rates both rates of events and individual patients and then total number of overall events and I think that's kind of all I can say on that.

Speaker #6: First, I'd like to announce that we are planning to host three webcasts over the coming months as part of our R&D webinar summer series.

Speaker #6: Each webcast will cover a specific aspect of our pipeline where we expect to have upcoming data readouts this year. These include cardiometabolic, including Plasazaran, Zodazaran, and Arrow Dimer PA, obesity, including arrow inhibin E and arrow ALK7, and arrow MAP-T, including the blood-brain barrier or BBB platform.

Edition satisfaction and forward. Prescribing intent, or both extremely strong. Refill activity is accelerating and we have a series of Highly anticipated. Milestones in the second half of 2026 and we believe will be transformative for the cardio metabolic franchise. And for Arrowhead with that, I'll turn the call over to James Hamilton to discuss the broader R&D portfolio.

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.

Speaker #2: We're still blinded and, like we said, should have the data in Q3.

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.

Speaker #4: Great. Looking forward to that. Thank you.

Speaker #6: I'll now give status updates from the quarter on these specific areas. First, let's review the suite of Plasazaran, Phase 3 studies, Shasta 3, Shasta 4, Shasta 5, and MIR3 designed to support supplemental NDA filings to expand the Redemplo label beyond genetic and clinical FCS into patients with SHTG.

Each webcast will cover a specific aspect of our pipeline where we expect to have upcoming data readouts this year.

Speaker #3: Thank you. One moment for our next question. Our next question comes from Jason Gerbery of Bank of America. Your line's now open.

These include cardio metabolic including plazas and zoom and arridy PA.

Obesity, including arrow and Gibby, and arrow out 7.

Speaker #5: Hey, guys. Thanks for taking my question. I just wanted to probe in a little bit more on the INHIBE and ALK7 updates later this year and get your latest thoughts on these modalities and take investors have soured a little bit on INHIBE after the WAVE data update.

And arrow Mt, including the blood brain barrier or BBB platform.

Speaker #6: 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.

I'll now give status updates from the quarter on these specific areas.

James Hamilton: 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. MIRROR III, 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 in the 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 MIRROR III in mid-2026 to support a planned top-line data readout in Q3.

Speaker #5: So just wanted to get your perspective on kind of what you need to see from these upcoming readouts both for obesity treatment versus any alternative potentially considering for a MASH indication.

Speaker #6: MIR3, 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 that directly assess the ability of Plasazaran to reduce the risk of acute pancreatitis as the primary endpoint.

First, let's review The Suite of possessor and phase 3 studies. Shasta 3, Shasta 4, Shasta 5, and mirror 3 design to support supplemental. NDA filings to expand the Redemptive label Beyond genetic and clinical SCS in the patients from shtg.

Speaker #5: Thanks.

Speaker #2: Yeah, hi, Jason. This is James. Sure, happy to cover those questions. We've been saying all along, really, that we thought that this INHIBE and ALK7 and ACCESS is interesting but we thought the approach was to combine with GLP-1s and that's still our standpoint here.

Chester 3, and Chester 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.

Speaker #6: 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.

Speaker #6: We remain on schedule to complete the blinded portion of the Shasta 3, Shasta 4, and MIR3 in mid-2026 to support a planned top-line data readout in the third quarter.

Near 3 which enrolled over 1400 patients is designed to supplement, the shots to studies with additional patient. Safety data, we are also enrolling patients at high risk of acute. Pancreatitis can be shot to 5 to directly assess the ability of possessor and to reduce the risk of acute pancreatitis as the primary employee.

Speaker #2: We think that there's potential, particularly in the type 2 diabetics, for additional weight loss on top of tears appetite or other GLP-1s with either ALK7 knockdown or INHIBE and E knockdown.

Speaker #6: This would further support our plans for an SNDA submission for SHTG before the end of this year. Before moving on to Zodazaran, I'd like to highlight a presentation we made with new long-term efficacy and safety data for Plasazaran across a spectrum of patients with hypertriglyceridemia at the American College of Cardiology Conference in March.

James Hamilton: 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 two-year open-label extension of the two 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 two-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 remnant and non-HDL cholesterol.

Kids shot to 3 and shots to 4 show a statistically significant improvement in acute pancreatitis risk. We will reassess whether there is added value in continuing to justify.

Speaker #2: What we've seen from the clinical study that we talked about earlier this year from INHIBE and E with INHIBE and E knockdown is really clear redistribution of fat out of the liver, even with monotherapy, but also with combination therapy.

We remain on schedule to complete the blinded portion of the Shasta 3, Shasta 4 in year 3. In mid 2026, the support of plants Topline data readouts in third quarter,

Speaker #6: The data were from a two-year open-label extension of the two Phase 2B double-blind placebo-controlled studies of Plasazaran. Shasta 2 conducted in adults with severe hypertriglyceridemia and MIR, which enrolled patients with hypertriglyceridemia.

This would further support our plans for an S NDA submission for shtg before the end of this year.

Speaker #2: And some additional changes and improvements in body composition, reductions in total fat and visceral fat, particularly in that type 2 diabetic population. So I think that we look forward to more of the same and sharing more of that liver fat data here in the coming quarter or so.

Speaker #6: During the two-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 MIR.

Before moving on to disaster, Aunt, I'd like to highlight a presentation we made with new long-term efficacy and safety data for plazaster, and across a spectrum of patients with hypertriglyceridemia, at the American College of Cardiology conference in March.

Speaker #2: And then in the second half of the year, providing some additional updates on changes in body composition and some of the other parameters that we showed back in January.

The data were from a 2-year open label extension of the 2. Phase 2B, double blind, Placebo control studies of plaster. And

Speaker #6: With additional reductions in Remden 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.

Just the 2 conductors for severe hydro triglyceridemia and mirror which enrolled patients with hyper triglyceridemia.

James Hamilton: 96% of SHTG patients achieved TGs below 500 mg/dL, and 63% achieved TGs below 150 mg/dL, with 93% of HTG patients achieving TGs below 150 mg/dL. 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.

Speaker #3: Thank you. One moment for our next

Speaker #3: question. Our next question. Brian Chang. Of JP. Next one from Vinyl King.

Speaker #6: Importantly, no adjudicated acute pancreatitis events occurred in any patient receiving Plasazaran during the two-year Phase 2B open-label extension study. These findings support the potential of Plasazaran 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.

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 hpg patients from mirror with additional reductions in Remnant and non-hdl cholesterol.

TG is below. 150 milligrams per deciliter with 93% of HTG patients, achieving TGs below 150 milligrams per deciliter.

Speaker #6: I'd now like to give a quick update on the Yosemite Phase 3 study of Zodazaran, which is being developed as a potential treatment for homozygous familial hypercholesterolemia, or HOFH.

Importantly, no, adjudicated acute. Pancreatitis events occurred in any patient, receiving possessor and during the 2-year phase. 2B open label extension study.

Speaker #6: A rare genetic condition that leads to severely elevated LDL cholesterol and early-onset cardiovascular disease. Zodazaran is the fourth investigational RNAi-based candidate developed by Arrowhead to reach late-stage clinical studies.

These findings support, the potential of possessor is a promising new approach to managing patients with moderate to severe HTG phenotypes for at risk of AP and potentially other cardio metabolic comorbidities.

James Hamilton: 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-to-1 to receive 5 doses of 200 milligrams of zodasiran or placebo. The primary endpoint is the percent change from baseline to month 12 in fasting LDL cholesterol. Enrollment has been on track, 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.

Speaker #6: Yosemite is designed to enroll approximately 60 individuals with HOFH over the age of 12 who will be randomized two-to-one to receive five doses of 200 milligrams of Zodazaran or placebo.

Speaker #6: 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.

Speaker #6: The last program within cardiometabolic is Arrow Dimer PA. The first dual-functional siRNA designed to silence the expression of two genes with a single RNAi molecule.

Speaker #6: Arrow 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 1, 2A placebo-controlled dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and effects on LDL cholesterol and triglycerides using single-dose Arrow Dimer PA in Part 1 and multiple doses in Part 2 in up to 78 adults with mixed hyperlipidemia.

James Hamilton: 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 I and multiple doses in Part II 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 that potentially accelerate the path to regulatory approval, so we're eager to have a first clinical readout to start moving ahead with 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.

Speaker #6: 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.

Speaker #6: 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.

Speaker #6: So we're eager to have a first clinical readout to start moving ahead with later studies if supported by initial data. Lastly, I'd like to give an update on the status of the ARROWMAP-T first-in-human study.

Speaker #6: ARROWMAP-T 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.

James Hamilton: 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 the central nervous system, including deep brain regions after subcutaneous injection.

Speaker #6: And as part of a group of neurodegenerative diseases called tauopathies, that are marked by abnormal tau accumulation and formation of tau tangles in neurons.

Speaker #6: Tau-related pathology may be a critical driver of neurodegeneration and targeting tau as a promising strategy to potentially slow or stop cognitive and functional decline.

Speaker #6: ARROWMAP-T 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.

Speaker #6: 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.

James Hamilton: 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.

Speaker #6: In December 2025, we dosed the first subjects in a Phase 1, 2 clinical trial of ARROWMAP-T. This study is a placebo-controlled dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARROWMAP-T 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.

Speaker #6: In Part 1A of the study, healthy subjects will receive one or three weekly doses of ARROWMAP-T 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 ARROWMAP-T or placebo.

Speaker #6: 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.

James Hamilton: 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 Daniel Apel.

Speaker #6: 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 Appel.

Speaker #1: Thank you, James, and good afternoon, everyone. As we reported today, net loss for the quarter ended March 31, 2026, was 132.7 million dollars, or a loss of 93 cents per share.

Daniel Apel: Thank you, James, and good afternoon, everyone. As we reported today, net loss for the quarter ended 31 March 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 31 March 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.

Daniel Apel: 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 agreement between Sanofi and Visirna to develop and commercialize investigational plozasiran in Greater China.

Speaker #1: 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 clinical supply provided to them under clinical supply agreement.

Speaker #1: In addition, we recognized 20 million of the 200 million dollar upfront payment received from Novartis in October bringing year-to-date recognition of Novartis upfront to 54 million, with the remaining 146 million dollars to be deferred over time as we fulfill our preclinical obligations.

Speaker #1: We also recorded 11 million related to the asset purchase agreements between Sanofi and Vicerna, developed and commercialized investigational pedestrian in Greater China. Vicerna, as you know, is our majority-owned subsidiary with operations in China.

Daniel Apel: Visirna, as you know, is our majority-owned subsidiary with operations in China, and the amount recognized was almost entirely due to the January approval of FCS in that region by the 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.

Speaker #1: And the amount recognized was 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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: Turning now to expenses, total operating expenses for the quarter were approximately $250 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.

Daniel Apel: 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 and SHTG, as well as our early-stage pipeline programs, including ARO-DIMER-PA and MAPT. Fiscal year to date, almost two-thirds of the clinical trial spend can be attributed to our plozasiran phase III studies.

Speaker #1: This increase was driven by 40 million of higher R&D expenses and 13 million of higher SGA expenses. Fully in line with our expectations. The increase in R&D expense was primarily attributable to ongoing progression of our Phase 3 registration of studies for prazosin and SHTG, as well as our early-stage pipeline programs including the Dimer and MAP-T.

Speaker #1: Fiscal year-to-date almost two-thirds of the clinical trial spend can be attributed to our prazosin Phase 3 studies. As James already mentioned, the registration of SHTG studies for prazosin should readout in the summer, and clinical trial spend for these programs should thereafter moderate accordingly.

Daniel Apel: As James already mentioned, the registration of SHTG studies for plozasiran should read out 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's 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 on FCS, while also positioning the organization to support a potential future launch in HoFH. 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 31 March 2026.

Speaker #1: SGA expenses increased year over year compared to the prior year's second fiscal quarter, driven primarily by ongoing investments to support the commercialization of Redemplo.

Speaker #1: 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.

Speaker #1: 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 prazosin for the treatment of HOFH.

Speaker #1: Turning to the balance sheet, cash and investments on hand total nearly $1.8 billion as of March 31, 2026. Common shares outstanding at quarter-end were 140.6 million.

Daniel Apel: Common shares outstanding at quarter end were 140.69. 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 D01 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.

Speaker #1: 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 ultimate of 0% convertible senior notes and common stock, along with the associated capped call transactions.

Speaker #1: Other notable inflows in the quarter include the $200 million received from Sarepta upon achieving the second Tier 1 program milestone, as well as a $50 million anniversary payment under the Sarepta long-term collaboration agreement.

Speaker #1: With that brief overview, I will now turn the call back to Chris.

Daniel Apel: With that brief overview, I will now turn the call back to Chris.

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 these areas, but 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. There are just a few of the events we are tracking. SHASTA-3, SHASTA-4, and MUIR-3, which is a suite of phase III clinical studies designed to support an sNDA for REDEMPLO in patients with FCS, is on schedule for completion and top-line readout in Q3.

Speaker #2: Here are just a few of the events we are tracking. JASSA 3, JASSA 4, and YEAR 3, which is the suite of Phase 3 clinical studies designed to support an SNDA for Redemplo in patients with SHTG, is on schedule for completion and top-line readout in Q3.

Speaker #2: The first clinical readout of aerodimer PA targeting both PCSK9 and APOC3 for LDL and TG lowering is also expected in Q3. The first clinical readout for AeroMAP-T is expected around the end of Q3 or early Q4.

Christopher Anzalone: 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. This 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-inhibitor 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 three presentations as part of our summer series of R&D webinars to go over cardiometabolic broadly, obesity, and ARO-MAPT.

Speaker #2: Additional AeroINHPE and AeroALK7 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.

Speaker #2: As James mentioned, we are planning to webcast three presentations as part of our summer series of R&D webinars, to go over cardiometabolic broadly, obesity, and AeroMAP-T.

Speaker #2: These can serve as a review of the programs, and results to date, and as a primer to the potentially important readouts coming up later this year.

Christopher Anzalone: These can serve as a review of the programs and results to date and as a primer to the potentially important readouts coming up later this year. Thanks for joining us today. I would now like to open the call to your questions.

Speaker #2: Thank you for joining us today, and I would now like to open the call to your questions.

Speaker #3: Thank you. At this time, we will now conduct the question-and-answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone, and wait for your name to be announced.

Operator: Thank you. At this time, we will now conduct the question and answer session. As a reminder, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please note that each analyst is permitted to ask one question. Should you have a follow-up question, you will need to get back in queue. Please stand by while we compile the Q&A roster. Our first question comes from the line of Edward Tenthoff from Piper Sandler. Your line is now open.

Speaker #3: Please stand by while we compile the Q&A roster. Our first question comes from the line of Edward Tenthoff from Piper Sandler. Your line is now open.

Speaker #4: Great. Thank you. And thanks for all the detail in the update today. My question really has to do with looking at the upcoming SH severe hypertriglyceridemia readouts.

Edward Tenthoff: Great. Thank you. Thanks for all the detail in the update today. My question really has to do with looking at the upcoming Severe Hypertriglyceridemia readouts. When it comes to, I guess, pancreatitis as a secondary, is the plan to pool SHASTA-4, SHASTA-3 and SHASTA-4? What are sort of the assumptions around pancreatitis? Thank you.

Speaker #4: When it comes to pancreatitis as a secondary, is the plan to pool Shasta 4, 3, and 4? And what are sort of the assumptions around pancreatitis?

Speaker #4: Thank you.

Speaker #2: Yeah, I'd say thanks for the question. This is James. Yeah, you've got that right. The plan is to pool both of those studies: Shasta 3 and 4, and we'll analyze do a meta-analysis of those two studies to look at pancreatitis event rates both rates of events in individual patients and then total number of overall events and I think that's kind of all I can say on that.

James Hamilton: Yeah. Hi, Jed. Thanks for the question. This is James. Yeah, you got that right. The plan is to pool both of those studies, SHASTA-3 and SHASTA-4. We'll analyze, do a meta-analysis of those two studies to look at pancreatitis event rates, both rates of events in individual patients and then total number of overall events. I think that's kind of all I can say on that. We're still, you know, we're still blinded and, like we said, should have the data in Q3.

Speaker #2: We're still blinded and, like we said, should have the data in Q3.

Speaker #4: Great. Looking forward to that. Thank you.

Edward Tenthoff: Great. Looking forward to that. Thank you.

Speaker #3: Thank you. One moment for our next question. Our next question comes from Jason Gerberry of Bank of America. Your line's now open.

Operator: Thank you. One moment for our next question.

Operator 2: Our next question comes from Jason Gerbury of Bank of America. Your line's now open.

Operator: Our next question comes from Jason Gerbury of Bank of America. Your line's now open.

Speaker #5: Hey, guys. Thanks for taking my question. I just wanted to probe in a little bit more on the InhibE and ALK7 updates later this year and get your latest thoughts on these modalities and think investors have soured a little bit on InhibE after the WAVE data update.

Jason Gerbury: Hey, guys. Thanks for taking my question. Just wanted to probe in a little bit more on the INHBE and ALK7 updates later this year, and get your latest thoughts on these modalities. I think investors have soured a little bit on INHBE after the WAVE data update. Just wanted to get your perspective on kinda what you need to see from these upcoming readouts to, you know, advance one or both for obesity treatment versus, you know, any alternative potentially considering for a MASH indication. Thanks.

Jason Gerberry: Hey, guys. Thanks for taking my question. Just wanted to probe in a little bit more on the INHBE and ALK7 updates later this year, and get your latest thoughts on these modalities. I think investors have soured a little bit on INHBE after the WAVE data update. Just wanted to get your perspective on kinda what you need to see from these upcoming readouts to, you know, advance one or both for obesity treatment versus, you know, any alternative potentially considering for a MASH indication. Thanks.

Speaker #5: 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 in the alternative, potentially considering for a MASH indication.

Speaker #5: Thanks.

Speaker #6: Yeah, hi, Jason. This is James. Sure, happy to cover those questions we've been saying all along, really, that we thought that this InhibE, ALK7, and ACCESS is interesting but we thought the approach was to combine with GLP-1s and that's still our standpoint here.

James Hamilton: Yeah. Hi, Jason. This is James. Sure happy to cover those questions. You know, we've been saying all along really that we thought that this INHBE ALK7 access is interesting, we thought the approach was to combine with GLP-1s. That's 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 ALK7 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, also with combination therapy.

Speaker #6: 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 ALK7 knockdown or InhibE knockdown.

Speaker #6: What we've seen from the clinical study that we talked about earlier this year from InhibE with InhibE knockdown is really clear redistribution of fat out of the liver, even with monotherapy, but also with combination therapy.

Speaker #6: And some additional changes and improvements in body composition, 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 to sharing more of that liver fat data here in the coming quarter or so.

James Hamilton: Some additional changes, improvements in body composition, reductions in total fat and visceral fat, particularly in that type 2 diabetic population. We look forward to more of the same and sharing more of that liver fat data here in the coming Q or so. In the H2 of the year, providing some additional updates on changes in body composition and some of the other parameters that we showed back in January.

Speaker #6: And then in the second half of the year, providing some additional updates on changes in body composition and some of the other parameters that we showed back in January.

Speaker #3: Thank you. One moment for our next question. Our next question comes from Brian Chang of JPMorgan. Your line is now open.

Operator 2: Thank you. One moment for our next question. Our next question comes from Brian Chang of JP Morgan. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from Brian Chang of JP Morgan. Your line is now open.

Speaker #7: Hi, guys. This is Ron on for Brian. Got some of the quarter. Just wanted to ask, can you guys give more color on the interactions you've had with payers that led to the recent price lowering?

[Analyst] (JP Morgan): Hi, guys. 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? What has been the feedback since your competitor's action last month? Thank you.

Ron Feiner: Hi, guys. 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? What has been the feedback since your competitor's action last month? Thank you.

Speaker #7: And what has been the feedback since your competitors' action last month? Thank you.

Speaker #6: Yeah, hi, 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 FTS patients through multiple diagnosis pathways, in particular through the clinical criteria.

Andy Davis: Hi, Ron. This is Andy. 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. Really positive conversations with payers about payer policies and about future coverage.

Speaker #6: That we saw in Palisade. So really, really positive conversations with payers about payer policies. And about future coverage.

Speaker #7: Okay. And just a quick follow-up, could you guys how should we think about the impact here that goes to net following the price lowering?

[Analyst] (JP Morgan): Okay. Just a quick follow-up. Could you guys, how should we think about the impact here of gross to net following the price lowering?

Ron Feiner: Okay. Just a quick follow-up. Could you guys, how should we think about the impact here of gross to net following the price lowering?

Speaker #6: Well, it's gross to net. Dan can take that. What's our assumption on gross to net with the new pricing policy?

Christopher Anzalone: Well, gross to net. Dan, can you take that? What's our assumption on gross to net with the new pricing policy?

Speaker #7: Yeah. So I mean, we ignore the I should answer your second question. We ignore the WAG-2. As Chris already explained, to make it premium price to the competitor there.

Daniel Apel: Yeah. We I mean, I should answer your second question. We ignore the WAC too, as Chris already explained, to make that, you know, premium price to the competitor there. We are not actually gonna give guidance on gross to net. We have not seen anything substantial in that regard, nor do we currently expect it. You know, other than things that were statutorily required, such as Medicaid rebates and the manufacturer discount program and the like. But we have a policy at the moment not to provide any sort of guidance or on that at this stage.

Okay. And uh just a quick follow up. Could you guys um

How should we think about the impact here at gross? Janet following the price lowering?

Speaker #7: We are not actually going to give guidance on gross to net. We have not seen anything substantial in that regard. Nor do we currently expect it.

What's our assumption on gross now that the price of policy?

yeah, so we I mean, we

Speaker #7: Other than things that are statute, statutorily required, such as Medicaid rebates and the manufacturer discount program and the like, so but we have a policy at the moment not to provide any sort of guidance or on that at this stage.

Ignore the time to answer your second question. We lower the wage to is Chris already explained to me that um you know, premium price to, to better their

We are—we are not actually going to give guidance on a gross of that. We have not seen anything.

Speaker #6: And let's just be clear. The lowering of the WAG from 60 to 45 had nothing to do with any pushback from payers to the contrary.

Substantial in that regard, no, to be currently expected.

Christopher Anzalone: Let's just be clear. The lowering of the WAC from 60 to 45 had nothing to do with any pushback from the payers. The contrary, I think that those interactions have been quite positive. You know, this is a lowering of the WAC in expectation of an expansion on the market into SHTG and to ensure this, that we are, you know, that the payers would not require a step-through with our competitor. As we talked about, you know, we are priced at a premium here. We think that's appropriate, you know, given the characteristics of our drug versus the competitor's drug.

Speaker #6: I think that those interactions have been quite positive. This is a lowering of the WAG in expectation of an expansion on the market into FHTG and to ensure that we are that we would the payers would not require a step-through with our competitor.

uh, you know, other than things that were statute, such totally required such as Medicaid, rebates and the manufacturing discount program and the

like so, um but we we have a policy at the moment not to not to provide any sort of guidance or

Speaker #6: As we talked about, we are priced at a premium here. We think that's appropriate. Given the characteristics of our drug versus the competitor's drug.

Speaker #6: And we think 45 actually long-term is probably quite a good price in terms of maximizing access to the drug across various subpopulations within FHTG.

Christopher Anzalone: We think 45 actually, you know, long term is probably quite a good price in terms of maximizing access to the drug across various subpopulations within SHTG.

Speaker #7: Great. Thank you so much.

Speaker #6: You're welcome.

[Analyst] (JP Morgan): Great. Thank you so much.

Ron Feiner: Great. Thank you so much.

Speaker #3: Thank you. One moment for our next question. Our next question comes from Mike Olds from Morgan Stanley. Your line's now open.

James Hamilton: You're welcome.

Operator 2: Thank you. One moment for our next question. Our next question comes from Mike Olds from Morgan Stanley. Your line's now open.

Operator: Thank you. One moment for our next question. Our next question comes from Mike Olds from Morgan Stanley. Your line's now open.

Or, um, on that at this stage. And let's just be clear the, the the lowering of the wax, the 60 to 45 has had nothing to do with any push back from repairs to the contrary, I think that that those interactions have been quite positive. Um, you know, this is this is a lowering of the of the wac in uh, expectation of um, of an expansion on the market in HTG and to ensure that that that we are, you know, that that that uh that we would, the parents would not require a step through, uh, with our competitor. Um, as we talked about, you know, we are priced at a premium here, we think that's appropriate. You know, given the characteristics of our drug person, they can be used at vendors Drive. Um, and we think 45 actually, you know, long term is it is is probably quite a good price in terms of of maximizing.

Speaker #8: Hey, guys. It's Alvin Novak on the line for Mike. Thank you for taking our questions and congrats on the quarter. I guess among the patients who were switchers, could you characterize I guess the motivations for switching to Redemplo?

Access the drive across various, uh, some populations Within fhg.

[Analyst] (Morgan Stanley): Hey, guys. Savi Novak on the line for Mike. Thank you for taking our questions and congrats on the quarter. I guess among the patients who were switchers, could you characterize, you know, I guess the motivations for switching to REDEMPLO? Was it due to its clinical profile, or could it be more pay-related? Thanks.

Avraham Novick: Hey, guys. Savi Novak on the line for Mike. Thank you for taking our questions and congrats on the quarter. I guess among the patients who were switchers, could you characterize, you know, I guess the motivations for switching to REDEMPLO? Was it due to its clinical profile, or could it be more pay-related? Thanks.

Great, thank you so much.

You're welcome. Thank you.

Speaker #8: Was it due to its clinical profile or could it be more payer-related? Thanks.

1 moment for our next question.

Speaker #6: Hi, Mike. This is Andy. Thanks for the question. We've seen really diversity of reasons for switch that include efficacy, safety, and tolerability. And the variety of other reasons as well.

Andy Davis: Hi, Mike. This is Andy. Thanks for the question. We've seen really diversity of reasons for switch that include efficacy, safety, and tolerability in the variety of other reasons as well. I wouldn't say there's one particular reason driving switch. There's a multitude of reasons.

Our next question comes from Mike S from Morgan Stanley Airlines. Now open

Speaker #6: So I wouldn't say there's one particular reason driving switch. There's a multitude of reasons.

Hey guys, it's a Nova on the line for Mike. Thank you for taking our questions and grabs on the quarter. I guess, among the patients who were switchers, um, could you characterize, um, you know, I guess the motivations for switching to Redemption flow was it due to its clinical profile or um, could it be more payroll related? Thanks.

Speaker #8: Okay. Great. Thanks for taking our questions.

[Analyst] (Morgan Stanley): Okay, great. Thanks for taking our questions.

Avraham Novick: Okay, great. Thanks for taking our questions.

Speaker #3: Thank you. One moment for our next question. Our next question comes from Mary Raycroft from Jefferies.

Operator 2: Thank you. One moment for our next question. Our next question comes from Mary Raycroft from Jefferies.

Operator: Thank you. One moment for our next question. Our next question comes from Mary Raycroft from Jefferies.

Speaker #9: Hi. Thanks for taking my question. 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?

Hi, Mike. This is Andy. Thanks for the question. We've seen really diversity of reasons for switch that include efficacy. Safety and tolerability in the variety of other reasons as well. So I wouldn't say there's 1 particular reason driving switch is a multitude of reasons.

Mary Raycroft: Hi. Thanks for taking my question. Maybe just a follow-up to Ted's question earlier on SHASTA-3 and SHASTA-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. Could you potentially even keep the study blinded a little bit longer to get an adequate number of total events?

Maury Raycroft: Hi. Thanks for taking my question. Maybe just a follow-up to Ted's question earlier on SHASTA-3 and SHASTA-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. Could you potentially even keep the study blinded a little bit longer to get an adequate number of total events?

Okay. Great, thanks for taking our questions.

Thank you. One moment for our next question.

Speaker #9: And whether you'd be able to generate enough events by the time this study completes? Or could you potentially even keep the study blinded a little bit longer to get an adequate number of total events?

Our next question comes from Mary Ray Croft from Jeffries.

Speaker #6: Yeah. Hi, Maury. This is James. I'll take that question. So we're not giving any guidance on or sort of low-by-low details on the number of events we're seeing.

James Hamilton: Yeah. Hi, Mary. This is James. I'll take that question. 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, you know, the big reveal will be in Q3. No plans to extend the study or stay blinded for a longer period at this time.

Speaker #6: 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.

Hi. Uh thanks for taking my question. Uh maybe just a follow-up to Ted's question earlier on Shasta 3 and 4 just wondering if um 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.

Speaker #9: Got it. Okay. Thanks for taking my questions.

Mary Raycroft: Got it. Okay, thanks for taking my questions.

Maury Raycroft: Got it. Okay, thanks for taking my questions.

Speaker #3: Thank you. One moment. For our next question. Our next question comes from Manny Faruhar from Lyrink. Your line is now open.

Operator 2: Thank you. One moment for our next question. Our next question comes from Mani Foroohar from Leerink Partners. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from Mani Foroohar from Leerink Partners. Your line is now open.

Yeah I'm already. This is this is James I'll take that question. Absolutely. So we're not giving any guidance on or sort of blow by blow details on the number of events. We're seeing to places to say, we feel comfortable that would put the number of events. We we have seen and

You know the the the the reveal will be in Q3 but no plans to extend the study or stay blinded for a longer period of time.

Speaker #10: Hi. You have the line for Manny. Thanks for taking my question. Congrats on the culture. So yeah, can you talk about how the phase 3 survey data from Biogen will inform the strategy for our MAPT?

Got it. Okay. Thanks for taking my questions.

[Analyst] (Leerink Partners): Hi, you have found for Mani Foroohar. Thanks for taking my question. Congrats on your quarter. Yeah. Can you talk about how the phase III Soria data from Biogen will inform the strategy for ARO-MAPT? Maybe also, can you just comment on your internal expectations for this readout? Thank you.

Mani Foroohar: Hi, you have found for Mani Foroohar. Thanks for taking my question. Congrats on your quarter. Yeah. Can you talk about how the phase III Soria data from Biogen will inform the strategy for ARO-MAPT? Maybe also, can you just comment on your internal expectations for this readout? Thank you.

Thank you. 1 moment for our next question.

Question comes from.

Speaker #10: And maybe also can you just comment on your internal expectations for this rebound? Thank you.

Manny fuhar from lank. Your line is now open.

Speaker #6: I don't think any of us caught that. Could you say that again? I think that the line is a bit muddled.

James Hamilton: I don't think any of us caught that. Could you say that again? I think the line is a bit muddled.

Christopher Anzalone: I don't think any of us caught that. Could you say that again? I think the line is a bit muddled.

Speaker #10: Oh, sorry. No, yeah, I was asking if you could talk about the phase 3 survey data from Biogen and how it won't form your strategy for our MAPT?

[Analyst] (Leerink Partners): Oh, sorry. no, yeah. I was asking if you could talk about the phase III Soria data from Biogen and how it will inform your strategy for ARO-MAPT.

Mani Foroohar: Oh, sorry. no, yeah. I was asking if you could talk about the phase III Soria data from Biogen and how it will inform your strategy for ARO-MAPT.

Hi, you have found for many. Thanks for taking my question, congrats on the culture. Um, so yeah. Can you talk about uh, how the place where your data from my general, informal strategy for aromaticity and maybe also can you just comment on your internal expectations for this rebound? Thank you.

Speaker #10: And you also talk about the internal expectations.

James Hamilton: Oh, I see.

[Analyst] (Leerink Partners): The general expectation.

Mani Foroohar: The general expectation.

Speaker #6: Sure. Yeah, I can take that. This is James. So the I'm assuming you're referring to the ASO targeting MAPT from Biogen and Ionis that's supposed to read out here in maybe this quarter or early next quarter.

James Hamilton: Sure. Yeah, I can take that. This is James. I'm assuming you're referring to the ASO targeting MAPT from Biogen and Ionis that's supposed to read out here in maybe this quarter or early next quarter. Yeah, I mean, I hope those data look good, and I hope that they show improvements 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?

I don't think any of us thought that could you could you, could you say that again? I think that the line is a bit muddled

Sorry, um no yeah, I was asking if you could talk about the phase 3, Sia data from Biogen and how it won't form your strategy for our map key.

Speaker #6: Yeah, 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.

Um, and you also expectation.

Yep, sure. Yeah, I can take that. This is James.

So the, uh, the the I'm assuming you're referring to the ASO.

Speaker #6: 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?

Speaker #6: Because a knockdown approach of tau should improve any condition. It's really driven by tau gain of function or tau pathology. So things like progressive supernuclear palsy or corticobasilar 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 2s and phase 3 down the road.

James Hamilton: Cause a knockdown approach of tau should improve any condition that's really driven by tau gain of function or tau pathology. Things like progressive supranuclear palsy or corticobasal dementia or some of the real specific MAPT gain of function frontotemporal dementia disorders. You know, those are all fair game for us as we think about phase II and phase III down the road. 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.

Starting map key from Biogen and ionis, that's supposed to read out here in maybe this quarter or early next quarter. Um, yeah, I mean, I I hope those data look good. And I, I hope that they show an improvement in the cognitive rating scales. I think that would be broadly a positive for, for arrowheads, and for the towel hypothesis. In general, of course that study is in Alzheimer's disease.

Speaker #6: So hopefully the Biogen data are positive. If it's not, it's not the end of the world for our program because we could still pursue the tauopathies.

Speaker #10: Great. Thank you.

[Analyst] (Leerink Partners): Great. Thank you.

Mani Foroohar: Great. Thank you.

Speaker #3: Thank you. One moment for our next question. Our next question comes from Joseph Thome from TD Cohen. Your line is now open.

Operator 2: Thank you. One moment for our next question. Our next question comes from Joseph Thome from TD Cowen. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from Joseph Thome from TD Cowen. Your line is now open.

Speaker #9: Hi there. Good afternoon. And thank you for taking my question. 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?

Joseph Thome: Hi there. Good afternoon, and thank you for taking my question. Just overthinking 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? Just a point of clarification, are you characterizing the AP events in SHASTA 3, 4 the same way that you characterize them in the long-term SHASTA 2 extension that was recently presented? Thank you.

And a positive readout with support our Alzheimer's programs, that being said that, even if those data are not positive, I think we can still we still have the option of pursuing, all the other telepathy, right? Because a knockdown approach of how should improve any, any condition is really driven by how gain of function or how pathology so things like Progressive super nuclear policy or code of political border, Dementia or um some of the real specific map team gain of function from the temporal dementia disorders. You know those are all fair game for us that as we think about Phase 2 and phase 3 down the road. So hopefully the Biogen data are positive. If it's not that it's it's not the end of the world for our program because we can still pursue the power of these

great. Thank you.

Thank you. One moment for our next.

Speaker #9: And then just a point of clarification, are you characterizing the AP events in Shasta 3/4 the same way that you characterize them in the long-term Shasta 2 extension that was recently presented?

Question. Our next question comes from Joseph, Tom from TD Colin, your line is now open.

Speaker #9: Thank you.

Speaker #6: Yeah. 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 Atlantic criteria.

James Hamilton: Yeah. Why don't I take the second part first about the characterization. The answer is no. The SHASTA 2 study, we used the strict Atlanta criteria to look at pancreatitis events, whereas in the SHASTA 3-4 pooled analysis, we're using this sort of modified Atlanta criteria that has definite, probable, and possible pancreatitis. Regarding the premium pricing, look, let's just see what those data look like. You know, historically, when we look at data side by side, you know, with the large caveat that 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.

Hi there. Good afternoon and thank you for taking my question. Um, just as we're thinking about the potential outcomes for the jasa. 34 studies later this year. Do you expect that? You'll have to show differentiated efficacy versus what Iona 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?

Speaker #6: To look at pancreatitis events, whereas in the Shasta 3/4 pooled analysis, we're using this sort of modified Atlantic criteria that has definite probable and possible pancreatitis.

Raising the AP events in Shasta, 34 the same way that you characterize them in the long term or shots at 2 extension. That was recently presented. Thank you.

Speaker #6: And regarding the premium pricing, what let's just see what those data look like. Historically, when we look at data side by side, with the large caveat that, of course, it's difficult to compare different clinical studies with different patient populations.

Christopher Anzalone: You know, historically, when we look at data side by side, you know, with the large caveat that 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.

Speaker #6: 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 a premium is still appropriate.

Second part first about the characterization, the answer is no. So the Shasta 2 study, we used the strict Atlantic criteria to to look at pancreatitis events. Whereas in the Shasta, 34 Pooles analysis, we're using this to modify, it Atlantic criteria that has that definite probable impossible.

James Hamilton: Should that be the case, we would expect a premium is still appropriate.

Christopher Anzalone: Should that be the case, we would expect a premium is still appropriate.

Speaker #9: Great. Thank you.

Speaker #6: You're welcome.

Joseph Thome: Great. Thank you.

Speaker #3: Thank you. Our next question comes from Patrick Truchio of HC Wainwright. Your line is now open.

James Hamilton: Welcome.

Operator 2: Thank you. Our next question comes from Patrick Trucchio of H.C. Wainwright. Your line is now open.

Operator: Thank you. Our next question comes from Patrick Trucchio of H.C. Wainwright. Your line is now open.

Speaker #11: Hi. Thanks so much. Just regarding your business development strategy, I was hoping you could give us some additional details just in terms of which assets you would be looking to bring forward on your own versus those that you may partner?

Patrick Trucchio: Hi. Thanks so much.

And regarding the uh, the premium pricing, but let's just see what they look like, you know, historically when we, when we look at at data side, you know, with with the large caveat, but of course it's difficult to compare different clinical studies, you know with different patient populations what we've seen consistently is is is superior to those right? Reductions Superior safety profile and of course Superior convenience, we expect those to continue. Um and should that be the case that we would expect um a bit of a premium is still appropriate

[Analyst]: Just regarding your business development strategy, I was hoping you could give us some additional details just in terms of which assets you would be looking to bring forward on your own versus those that you may partner. More broadly, how you're thinking about how RNAi kind of fits into the broader genetic medicines sort of portfolio and how, you know, how RNAi is looking sort of competitively against modalities like gene editing, et cetera?

Patrick Trucchio: Just regarding your business development strategy, I was hoping you could give us some additional details just in terms of which assets you would be looking to bring forward on your own versus those that you may partner. More broadly, how you're thinking about how RNAi kind of fits into the broader genetic medicines sort of portfolio and how, you know, how RNAi is looking sort of competitively against modalities like gene editing, et cetera?

Right. Thank you.

Thank you.

Speaker #11: 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, etc.

Our next question comes from Patrick tukio of HC Wayne Wright. Your line is now open.

Speaker #6: 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.

Christopher Anzalone: Sure. Look, I think that RNAi is at the forefront of genetic medicine, you know, for the foreseeable future. Now, look, it's not the right modality for everything. 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. You know, when we think about RNAi versus gene editing, you know, the way I feel at least is that, you know, RNAi is a relatively straightforward and conservative approach, right? It is a reversible approach. In our hands, you know, we can have very long durability.

Speaker #6: 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.

Um, modality is like United agent, Etc.

Uh, sure. Um

Speaker #6: 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?

Speaker #6: It is irreversible approach. And in our hands, we can have very long durability. 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 a knockdown that gene product.

Christopher Anzalone: You, 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, you know, should some new biology, you know, come out to suggest that you don't, you don't actually wanna knock down that gene product. That's not the case in gene editing. I think that gene editing does have a place in the world of medicine. It's just, it's just quite unknown right now because I don't know what happens, you know, to these edited genes 10 years from now. I don't, I don't think anybody does.

Speaker #6: That's not the case in gene editing. And I think the 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.

Speaker #6: I don't think anybody does. Notwithstanding, as the biology changes and it could be that sometime in the future, we decide that you might not want a knockdown a certain gene product.

Let's see, I I think that that um, that RNA is is at the Forefront of of genetic medicine, you know, for the foreseeable future. Now look it's not it's not the right modality for everything. Um but for those, for those diseases that are characterized by the open production of something, if we can address that sell site then then then rnai is a very attractive modality. But, you know, you know, when we think about about RNA versus Gene editing, um, um, uh, you know, the way I feel at least is that is that, you know, rni is a, is a relatively straightforward and, and and, uh, conservative approach, right? You know, it is a reversible approach. And, and, and in our hands, you know, we can have very long durability. So you, you can almost get the best of both worlds. Where if you have a low legal burden, if you will, um, like the ability to, to, um, to come off drugs, you know, should some new biology, you know, come out to suggest that you don't, you don't actually

Christopher Anzalone: Notwithstanding, as the biology changes and it could be that sometime in the future, we decide that you might not wanna knock down a certain gene product. For those horrible diseases that are terminal, it could be worth taking a risk to do gene editing. Frankly, for all others, if you can address something with RNAi, that feels to me a better approach. Regarding business 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 that idea of pushing all these forward ourselves.

Speaker #6: 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 as a better approach.

Want to knock down that two product. Um, that's not the case in, in genetically and, and I think the genetic team does have a place in, in, uh, in the world of medicine. It's just, it's just quite unknown right now because I don't know what happens, you know, to, uh, to these edited teams, uh, ten years from now on. I don't think anybody does, um, notwithstanding.

have biology changes and, and, and

Speaker #6: Regarding business 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.

Speaker #6: 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.

And it could be that that sometimes the future, we decide that they might not want to not going to certain certain product. So, so, you know, you know, for those for those, you know, the horrible diseases that are that are terminal, um, it it could be worth taking a risk to do Gene editing. Um, but frankly for for, you know, for all others, if you can address something with rnai that feels to me as a, a, a better approach.

Christopher Anzalone: With the possible exception of C3 and Factor B, we like those programs a lot. Those drug candidates appear to do what they're intending to do, and they seem to be well-tolerated. Those are just really outside of our core focus at present. Those are a couple assets that we could, you know, partner with the right partner at some point. Everything else feels pretty good right now. You know, look, that may change as we talk to other companies and as our pipeline grows, but we don't feel real sense of urgency to do additional deals on existing clinical programs other than maybe C3 and Factor B.

Speaker #6: 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.

Speaker #6: And so those are a couple of assets that we could partner with the right partner at some point. Everything else, it feels pretty good right now.

Speaker #6: What that may change as we talk to other companies, and as our pipeline grows. But we don't feel real sense of urgency to do additional deals on existing clinical programs other than maybe C3 and factor B.

Speaker #3: Thank you. Our next question comes from Amineh Chaharelli from B Riley Securities. Your line is now open.

Operator: Thank you. Our next question comes from Amin Chaharelli from B. Riley Securities. Your line is now open.

Speaker #12: Hi, everyone. Congratulations on the quarter. This is Amin Charelli on behalf of Madison El Sadi. I just wanted to ask, as you think about the next generation of the dimer platform, is there a construct combining inhibinE or ALK7 with a non-overlapping mechanism target, something you're evaluating for obesity or other indications?

Um, regarding the developments. Um, you know, this is a dynamic question. Um, right now, we feel pretty good about about our, our existing pipelines in terms of of, of that, which is, is wholly owned right now. You know, we like the idea of pushing all these for ourselves. You know what, the possible exception of C3, in fact, that we like the programs a lot of those those um, those drug candidates appear to do what they're intending to do. And they've seen me. Well tolerated, um those are just really outside of our, our core Focus as as as president. And so those are those are a couple assets that we could, you know, um, a partner with, with the right partner at some point, everything else feels pretty good right now. Um, you know what that may change as, as as as as as we talked to other companies, uh, and as our pipeline grows. But, but you don't feel, um, you don't feel real sense of urgency um, to do additional deals on existing clinical programs of it and maybe uh, 23

Amin Chaharelli: Hi, everyone. Congratulations on the quarter. This is Amin Chaharelli 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 inhibin E or ALK7 with a non-overlapping mechanism target, you know, something you're evaluating for obesity or other indications? Thank you.

Amine Chaherli: Hi, everyone. Congratulations on the quarter. This is Amin Chaharelli 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 inhibin E or ALK7 with a non-overlapping mechanism target, you know, something you're evaluating for obesity or other indications? Thank you.

Thank you.

Our next question comes from Amin chahar, Ali from B, Riley Securities. Your line is now, open.

Speaker #12: Thank you.

Speaker #6: Yes. Okay. We can move on to the next question.

Christopher Anzalone: Yes. Could we move on to the next question?

Christopher Anzalone: Yes.

James Hamilton: Could we move on to the next question?

Hi everyone. Uh, congratulations on the quarter. Uh, this is a mean Trail on behalf of Madison elsad. Um, I just wanted to ask, as you think about the next generation of the dimer. Platform is a construct. Combining, uh, inhibitor ALK 7. With a non overlapping mechanism Target. You know, something you're you're evaluating for for obesity or other indications.

Speaker #3: Yes. Our next question comes from Luca Issi from RBC Capital Markets. Your line is now open.

Thank you.

Operator: Yes. Our next question comes from Luca Issi from RBC Capital Markets. Your line is now open.

Yes.

Speaker #13: Oh, great. Hi, team. This is Shelby on for Luca. And thanks for taking the question. Given Ionis has announced a new price at 40K, it has first-mover advantage.

Okay, we move on to the next question.

[Analyst] (RBC Capital Markets): Oh, great. Hi, team. This is Shelby on for Luca, and thanks for taking the question. Given Ionis has announced a new price at $40K, and has first-mover advantage, can you walk us through the rationale to continue to price for REDEMPLO at a premium versus that par in SHTG, maybe as a way to kind of undercut their pricing since you're coming in second? Just wondering the rationale behind that. Thanks.

Shelby Hill: Oh, great. Hi, team. This is Shelby on for Luca, and thanks for taking the question. Given Ionis has announced a new price at $40K, and has first-mover advantage, can you walk us through the rationale to continue to price for REDEMPLO at a premium versus that par in SHTG, maybe as a way to kind of undercut their pricing since you're coming in second? Just wondering the rationale behind that. Thanks.

Yes.

Speaker #13: Can you walk us through the rationale to continue to price for Dimplo at a premium versus Zeptar and SHTG? Maybe as a way to kind of undercut their pricing since you're coming in second.

Our next question comes from Luca EC from RBC Capital markets, your line is now open.

Speaker #13: Just wondering the rationale behind that. Thanks.

Speaker #6: Yeah. Thanks, Shelby. As Chris previously mentioned, we do believe for Dimplo as a best-in-class APOC3 inhibitor in that it commands premium pricing as a consequence of that.

Andy Davis: Yeah. 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. 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. 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.

Speaker #6: 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.

Oh, great. Hi team. This is Shelby on for Luca and thanks for taking the question. Uh, given ionis has announced a new price at 40K. Um, it has first mover Advantage. Can you walk us through the rationale to continue to price for Dumbo at a premium versus that par and shpg? Um maybe as, as a way to kind of undercut their pricing since you're coming in second just wondering the rationale behind that.

Yeah, thanks Shelby is as Chris previously mentioned. We do believe

Speaker #6: 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.

Speaker #6: And then lastly, with a convenient dosing schedule that's only four injections a year. When you sum up the totality of those attributes, we just believe it's a best-in-class APOC3 inhibitor.

Speaker #6: And as a consequence, should be premium priced.

It was the best-in-class C3 inhibitor in 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 APLS C3 as a target and the depth of PG reduction. We saw that from Palisade with an 80% reduction from baseline. We saw that with the numerical decrease in acute pancreatitis from Palisade.

Speaker #3: Thank you. Our next question comes from Jen Jia from Cantor Fitzgerald. Your line is now open.

Operator: Thank you. Our next question comes from Jen Jia from Cantor Fitzgerald. Your line is now open.

Speaker #14: Hi. Thanks for taking my question. This is Jennifer Jia on for Prakhar Agrawal. I'd like to understand a little bit more on the expectations for Arrow dimer readout later this year.

We've seen that also with an FDA label that has no Contra indications, no warnings and no precautions. And then lastly, with a convenient dosing schedule, that's only for injections a year. When you sum up the totality of those attributes, we just believe it's a best-in-class A plus C3 inhibitor, and as a consequence should be premium price.

Jennifer Jia: Hi. Thanks for taking my question. This is Jennifer Jia on for Prakhar Agarwal. I'd like to understand a little bit more on the expectations for ARO-Dimer readout later this year. What effect are you hoping to see? What does it take to take this forward to a larger trial? If it's positive, do you consider going straight to a cardio outcomes trial, or will you still need to complete a phase II?

Speaker #14: 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?

Thank you. Our next, call. Our next question.

Comes from Jen Gia from Cantor, Fitzgerald. Your line is now open.

Speaker #14: Or will you still need to compete a phase two?

Speaker #6: Yeah. Hi, 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?

James Hamilton: Hi, Jennifer. This is James. Happy to address that question. The great thing about this program is that all of the relevant biomarkers and even, you know, biomarkers that you could use for potentially for approval are blood-based, right? We can measure PCSK9, we can measure APOC3 in the blood, and we can measure LDL cholesterol and triglycerides. ApoB, non-HDL cholesterol are all pretty easy for us to measure. 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, you know, 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, moving quickly into an outcome study down the road.

Speaker #6: We can measure PCSK9. We can measure APOC3 in the blood. And we can measure LDL cholesterol and triglycerides, ApoB, non-HDL cholesterol, are all pretty easy for us to measure.

Hi, thanks for taking my question. This is Jennifer Gia on for pekar aaal. Um, I'd like to understand a little bit more on the expectations for arridy, dimer, read out later this year. So, what effects see are you hoping to see, and, um, what does it take to take this 4 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?

To phase 2.

Speaker #6: 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.

Speaker #6: There may be some additional limited phase two work, which we could even consider doing as part of this study. But then moving quickly into an outcome study, down the road.

Yeah. Hi Jennifer. This is James happy to address that question. So the great thing about this program is that all of the the relevant biomarkers and even you know, biomarkers that you could use for potentially for that for approval are blood based, right? We can measure pcsk9, we can measure a plus C3 in the blood and we can measure LDL cholesterol and triglycerides, aob non-hdl cholesterol.

Speaker #6: So more to come on the development plan and the study designs. But looking forward to the readout later this year.

Christopher Anzalone: More to come on the development plan and the study designs, but, yeah, looking forward to the readout later this year.

James Hamilton: More to come on the development plan and the study designs, but, yeah, looking forward to the readout later this year.

Speaker #14: Great. Thanks.

Jennifer Jia: Great. Thanks.

Speaker #3: Thank you. Our next question comes from Keay Nakae from Sharden Capital Markets. Your line is now open.

Operator: Thank you. Our next question comes from Keay Nakae from Chardan Capital Markets.

Speaker #15: Yeah. Thank you. Question about the Madrigal licensing agreement for PMPLA. It's almost 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.

Keay Nakae: Yeah, thank you. Question about the Madrigal licensing 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.

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 read that, in terms of where we go from here. You know, I think we're working on that now, um, that there may be some additional limited Phase 2 work, which we could even consider doing as part of this study. But then moving quickly into, uh, into an outcome, study down the road. So um, more to come on the, uh, the development plan, and the study study designs. But, uh, yeah. Looking forward to the the readout later this year,

Great, thanks.

Thank you.

Our next question comes from Kia McKay from chardan Capital markets. Your line is now open.

Speaker #6: Yeah. It's a good question. So let me just take it back and remind everyone. Where PMPLA3, where Arrow PMPLA3 came from, we didn't develop this on our own independently.

Christopher Anzalone: Yes, good question. Let me just take it back and remind everyone that where PNPLA3, where ARO-PNPLA3 came from. We didn't develop this on our own independently. This was part of our deal with Janssen that was centered around HBV, FSBP, also included a couple of additional targets. This was one of those targets. So we developed it for them. They did the phase I. The phase I was compelling. You know, after only a single dose, they saw about a 40% reduction in liver fat in homozygous patients. That was interesting to us. Janssen, as I understand it, decided to get out of MASH, the asset was returned to us.

Uh, yeah, thank you. Um, question about the, uh, magical, uh, licensing agreement for pmpa help us understand, uh, from a capital, allocation strategy perspective.

Speaker #6: This was part of our deal with Janssen that was centered around HPV, hepatitis B, but also included a couple of additional targets. This was one of those targets.

Why it makes sense for you to do this deal at this time as opposed to taking the drug further on your own?

Speaker #6: And so we developed it for them. They did the phase one. The phase one was compelling. After only a single dose, they saw about a 40% reduction in liver fat in homozygous patients.

Speaker #6: So that was interesting to us. Janssen, as I understand it, decided to get out of match and so the asset was returned to us.

Speaker #6: We didn't spend any money on this. As we looked at taking this forward, we think it's a really compelling target for a company that's focused in match.

Christopher Anzalone: 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 MASH, largely. This is a genetically defined population, and that's sort of the good news and the bad news, right? You know, the good news is it's quite specific. The challenge there is that there will be, you know, a companion diagnostic component to this. It made sense for us to find, you know, a pure play MASH, a company to take this forward. Of course, Madrigal is, I think, the best out there right now. It made sense.

Speaker #6: 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.

Speaker #6: 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 match company to take this forward.

Yes, good question. Um, so so let me just take you back and and remind everyone um, that uh, where P like 3, where Arrow be like, we came from, we didn't develop this on our on our own independently and this was part of our, our deal with Jensen. Um, that was centered around hbv FSB, um, but also included a couple of personal Targets, this was 1 of those targets and so so we we developed it for them. They did The Phase 1, uh, The Phase 1 was compelling, you know, after only a single dose, they saw about a 40% reduction in liver fat, um, in homozygous, homozygous patients. So that was interesting uh, to us, um, Jansen as as I understand, he decided to get out of math and so the, the asset was returned to us, we didn't spend any money on it.

Speaker #6: And of course, Medical is, I think, the best out there right now. And so it made sense it didn't really make sense for us to spend much money right now to do a phase two those studies could be a bit long and more expensive than made sense for us.

Christopher Anzalone: It didn't really make sense for us, you know, to spend much money right now to do a phase II. You know, those studies could be a bit long and more expensive than made sense for us. You know, we've got a very large pipeline. I just think that, you know, our ROI is probably better, you know, by allocating capital to those programs that we are more confident that we will hold on to long term. That's where we went. You know, we are thrilled to have Madrigal as a partner. We're thrilled to have them develop that drug. We think it's a good drug. We're thrilled to have them commercialize it eventually.

Speaker #6: 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.

Um, as we look at at taking this forward, uh, we think it's a really compelling Target for a company that's focused in match. Uh, largely. Um, this is a genetically defined population, um, and that's sort of the good news and the bad news. Right. You know, the good news is it's it's quite specific. Um, The Challenge there is that is that there will be, you know, a a companion diagnostic onto this and it made sense uh, for us to find, you know, a pure play MASH uh uh uh a company to take this forward. Um, and of course a medical is. I think that

Speaker #6: So that's where it went. We are thrilled to have Madrigal as a partner. We're thrilled to have them develop that drug. I think it's a good drug.

Speaker #6: And we're thrilled to have them commercialize it eventually. So we feel good about the deal.

Christopher Anzalone: We feel good about the deal.

Speaker #15: Great. Thank you.

Speaker #6: Sure.

Keay Nakae: Great. Thank you.

Those studies could be, could be a bit long and, and, and more expensive than, than made sense for us. You know, we've got a very large pipeline, we've got some really interesting programs that we are pushing ourselves. And I just think that there are Roi is probably better um you know, by allocating Capital to those programs that we that we are more confident that we will hold on to long term.

Speaker #3: Thank you. This concludes the question and answer session. I would now like to turn it back to Chris Anzalone for closing remarks.

Christopher Anzalone: Sure.

Operator: Thank you. This concludes the question and answer session. I would now like to turn it back to Christopher Anzalone for closing remarks.

Speaker #6: Thanks, everyone, for joining us today. We look forward to seeing you in the future.

Um, so that's where we— that's where we went. You know, we are thrilled to have Navigators Department, we're thrilled to have them develop that drug, leads to good drugs, um, and we're thrilled to have them commercialize it eventually. So, um, we feel good about the— the

Christopher Anzalone: I thank everyone for joining us today, and we look forward to seeing you in the future.

Great. Thank you.

Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Thank you. This concludes the question and answer session, I would now like to turn it back to Chris and salon for closing remarks.

I thank you for 1 for joining us today. We look forward to seeing you uh, in the future.

Thank you for your participation. In today's conference, this does conclude the program. You may now disconnect

Mhm.

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Q2 2026 Arrowhead Pharmaceuticals Inc Earnings Call

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Q2 2026 Arrowhead Pharmaceuticals Inc Earnings Call

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