Q3 2026 Arrowhead Pharmaceuticals Inc Earnings Call

August 4, 2026

Operator: Welcome to the Arrowhead Pharmaceutical Conference Call. Throughout today's recorded presentation, all participants will be in a listen mode only. After the presentation, there will be an opportunity to ask questions. I will now hand the conference over to Vincent Anzalone, Senior Vice President of Investor Relations for Arrowhead. Please go ahead, Vincent.

Speaker #2: Moment. Welcome to the ARROWHEAD PHARMACEUTICAL CONFERENCE CALL. Throughout today's recorded presentation, all participants will be in a listen mode only. After the presentation, there will be an opportunity to ask questions.

Speaker #2: I will now hand the conference over to Vincent Anzalone, Senior Vice President of Investor Relations for ARROWHEAD. Please go ahead, Vincent.

Speaker #3: Thank you, and good afternoon, everyone. Thank you for joining us today to discuss Arrowhead's results for its fiscal 2026 third quarter, ended June 30, 2026.

Vincent Anzalone: Thank you. Good afternoon, everyone. Thank you for joining us today to discuss Arrowhead's results for its fiscal 2026 Q3 ended 30 June 2026. With us today for 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. Dan 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 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.

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

Speaker #3: 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 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.

Speaker #3: 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: 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: to turn the call over to Chris. I'd now like

Speaker #4: Thanks, Vince. Good afternoon, everyone, and thank you for joining us today. ARROWHEAD is now on the strongest footing in its history. Two weeks ago, we reported positive top-line phase three results from the Global Shasta III and Shasta IV studies in patients with severe hypertriglyceridemia, or SHTG, and we expect additional results to be presented later this month at the European Society of Cardiology topics.

Chris Anzalone: Thanks, Vince. Good afternoon, everyone, and thank you for joining us today. Arrowhead is now on the strongest footing in its history. Two weeks ago, we reported positive top-line phase III results from the global SHASTA-3 and SHASTA-4 studies in patients with severe hypertriglyceridemia or SHTG. We expect additional results to be presented later this month at the European Society of Cardiology conference. These data made clear to us that REDEMPLO is a needed therapy for SHTG patients. To that end, we announced today that we have acquired a priority review voucher, which can accelerate the regulatory review process in the United States from 10 months to 6 months, potentially bringing this important medicine to patients as quickly as possible. To me, this is an expression of Arrowhead values, push to create the best medicines and be creative and aggressive to rapidly get them to patients who need them.

Speaker #4: These data made clear to us that redemplo is needed therapy for SHTG patients. To that end, we announce today that we have acquired a priority review voucher which can accelerate the regulatory review process in the United States from 10 months to 6 months, potentially bringing this important medicine to patients as quickly as possible.

Speaker #4: To me, this is an expression of ARROWHEAD values: push to create the best medicines and be creative and aggressive to rapidly get them to patients who need them.

Speaker #4: Let's talk about the SHASTA-III and SHASTA-IV top-line results. Both studies met their primary endpoint and every pre-specified secondary endpoint—a clean sweep across two pivotal trials.

Chris Anzalone: Let's talk about the SHASTA-3 and -4 top-line results. Both studies met their primary endpoint and every pre-specified secondary endpoint, a clean sweep across two pivotal trials. Median triglyceride reductions from baseline were 79% and 81% in SHASTA-3 and SHASTA-4 respectively. These results were deep, durable, and remarkably consistent across both studies. Just as encouraging, safety and tolerability remained favorable and consistent with everything we've seen in prior studies. We observed no new safety signals, no clinically meaningful differences in routine laboratory measures, no clinically meaningful adverse changes in liver enzymes, no hypersensitivity cases, and no thrombocytopenia signal. In a pre-specified MRI-PDFF subgroup, there was no statistically significant difference in mean liver fat content between plozasiran and placebo. The acute pancreatitis findings are, in our view, the standout results.

Speaker #4: Median triglyceride reductions from baseline were 79% and 81% in Shasta III and Shasta IV, respectively. These results were deep, durable, and remarkably consistent across both studies.

Speaker #4: Just as encouraging, safety and tolerability remained favorable and consistent with everything we've seen in prior studies. We observed no new safety signals, no clinically meaningful differences in routine laboratory measures, no clinically meaningful adverse changes in liver enzymes, no hypersensitivity cases, and no thrombocytopenia signal.

Speaker #4: In a pre-specified MRI PDFS subgroup, there was no statistically significant difference in mean liver fat content between pozasteran and placebo. The acute pancreatitis findings are, in our view, to stand out results.

Speaker #4: Across the broad SHTG population, patients with triglycerides above 500 milligrams per deciliter with or without history of pancreatitis. Cumulative acute pancreatitis events were reduced by 78% versus subgroup, patients with triglycerides above 880 milligrams per deciliter and a history of acute pancreatitis, we saw a 100% reduction in events versus placebo.

Chris Anzalone: Across the broad SHTG population, patients with triglycerides above 500 mg/dL with or without history of pancreatitis. Cumulative acute pancreatitis events were reduced by 78% versus placebo. In the highest-risk subgroup, patients with triglycerides above 880 mg/dL and a history of acute pancreatitis, we saw a 100% reduction in events versus placebo. Detailed results are expected to be presented at a hotline late breaker at the European Society of Cardiology Congress on 30 August, followed by an Arrowhead webcast on 31 August. We intend to submit an sNDA to the FDA before the end of 2026, followed by additional global filings. If approved, SHTG would represent a substantially larger commercial opportunity than FCS. It would let us utilize the infrastructure we're building today for a much broader patient population.

Speaker #4: Detailed results are expected to be presented at a Hotline Late-Breaker at the European Society of Cardiology Congress on August 30th, followed by an Arrowhead webcast on August 31st.

Speaker #4: We intend to submit an FNDA to the FDA before the end of 2026, followed by additional global filings. If approved, SHTG would represent a substantially larger commercial opportunity than FCS, and it would let us utilize the infrastructure we're building today for a much broader patient population.

Speaker #4: We believe the SHASTA results materially de-risk our most important near-term label expansion opportunity and further strengthen the foundation of our cardiometabolic franchise. As we consider how we could fit into SHTG therapeutic paradigms, we think of redemplo in three ways.

Chris Anzalone: We believe the SHASTA results materially de-risk our most important near-term label expansion opportunity and further strengthen the foundation of our cardiometabolic franchise. As we consider how we could fit into SHTG therapeutic paradigms, we think of REDEMPLO in three ways: safe, simple, and strong. Safe because of the impressive tolerability we saw in the PALISADE Phase III and resulting clean label in FCS, combined with what we saw in SHASTA-3 and -4 across multiple measures, including quiet liver enzymes, no hypersensitivity, and no increase in liver death. Simple because of quarterly dosing, no anticipated need for liver enzyme monitoring, and a 25 mg dose for all patients rather than having to titrate up. Strong because of the unprecedented reductions in triglyceride levels from baseline across multiple studies. We see this as a clearly compelling value proposition for patients, healthcare providers, and payers.

Speaker #4: Safe, simple, and strong. Safe because of the impressive tolerability we saw in the Palisade phase three and resulting clean label in FCS, combined with what we saw in Shasta III and IV across multiple measures, including quiet liver enzymes, no hypersensitivity, and no increase in liver fat.

Speaker #4: It's simple because of quarterly dosing, no anticipated need for liver enzyme monitoring, and a 25-milligram dose for all patients rather than having to titrate up.

Speaker #4: And strong because of unprecedented reductions in triglyceride levels because of unprecedented reductions in triglyceride levels from baseline across multiple studies. We see this as a clearly compelling value proposition for patients, healthcare providers, and payers.

Speaker #4: Therefore, the speed at which we can bring pozasteran to the broader SHTG population is critical. The possibility of shaving four months off the approval process through the priority review voucher we acquired is important.

Chris Anzalone: Therefore, the speed at which we can bring plozasiran to the broader SHTG population is critical. The possibility of shaving 4 months off the approval process through the priority review voucher we acquired is important. We have a saying at Arrowhead that is even etched in the floor of one of our facilities. It is that every day matters. This is a driving principle for us from discovery to early development, to late-stage clinical, to regulatory interactions, and ultimately to the last mile, getting important medicines to the patients who need them. Turning to execution of this last mile, our US REDEMPLO launch for FCS continued to build real momentum during the quarter. We've seen greater than doubling of prescriptions quarter-on-quarter. Andy will talk through our progress in a moment, including prescription and market access progress, and I think you'll come away as encouraged as we are.

Speaker #4: We have a saying at ARROWHEAD that is even etched in the floor of one of our facilities: it is that every day matters. This is a driving principle for us from discovery to early development to late-stage clinical to regulatory interactions, and ultimately to the last mile, getting important medicines to the patients who need them.

Speaker #4: Turning to execution of this last mile, our U.S. redemplo launch for FCS continued to build real momentum during the quarter. We've seen greater than doubling of prescriptions quarter on quarter.

Speaker #4: Andy will talk through our progress in a moment, including prescription and market access progress, and I think you'll come away as encouraged as we are.

Speaker #4: This launch in FCS has given us valuable experience and a scalable foundation to build on. Physicians are identifying previously untreated FCS patients, prescribing activities broad, and our team is building the capabilities we'll need for a much larger potential SHTG launch.

Chris Anzalone: This launch in FCS has given us valuable experience and a scalable foundation to build on. Physicians are identifying previously untreated FCS patients, prescribing activity is broad, and our team is building the capabilities we'll need for a much larger potential SHTG launch. We also continue to expand REDEMPLO's reach outside the United States. In May, Australia's Therapeutic Goods Administration approved REDEMPLO as the first and only medicine approved for FCS in Australia, including genetically confirmed and clinically diagnosed adults. In June, the European Commission formally granted marketing authorization, making REDEMPLO the first and only oligo-based medicine authorized by the EC for adults with FCS diagnosed through either clinical criteria or genetic testing. Together with our approvals in the United States, Canada, China, and Australia, the EU authorization gives REDEMPLO an approved footprint across five geographies, an important achievement we're very proud of.

Speaker #4: We also continue to expand redemplo's reach outside the United States. In May, Australia's Therapeutic Goods Administration approved redemplo as the first and only medicine approved for FCS in Australia, including genetically confirmed and clinically diagnosed adults.

Speaker #4: In June, the European Commission formally granted marketing authorization making redemplo the first and only oligo-based medicine authorized by the EC for adults with FCS diagnosed through either clinical criteria or genetic testing.

Speaker #4: Together with our approvals in the United States, Canada, China, and Australia, the EU authorization gives Redemplo an approved footprint across five geographies and important achievements we're very proud of.

Speaker #4: We're now working through country-specific reimbursements and launch processes while Sanofi leads commercialization in Greater China. All of the commercial infrastructure we're building we are building is intended not only to hopefully bring pozasteran to SHTG patients, but also to serve as the basis for our broader cardiometabolic franchise, which we expect to include zodasteran, aerodymer PA, obesity treatments, and other candidates you will hear more about in coming quarters.

Chris Anzalone: We're now working through country-specific reimbursement and launch processes while Sanofi leads commercialization in Greater China. All the commercial infrastructure we are building is intended not only to hopefully bring plozasiran to SHTG patients, but also to serve as the basis for our broader cardiometabolic franchise, which we expect to include plozasiran, ARO-PNPLA3, obesity treatments, and other candidates you will hear more about in coming quarters. We're building a large number of potential medicines that could use the same commercial channels, hopefully providing us with substantial scalability and cost-effective growth. We view plozasiran as providing us with a strong value foundation. Our intention is to build on that aggressively, and we have made good progress recently toward that end. At EASL, we presented interim phase IIa data for ARO-INHBE in obesity and MASH, and the results were compelling.

Speaker #4: We're building a large number of potential medicines that could use the same commercial channels, hopefully providing us with substantial scalability and cost-effective growth. We view pozasteran as providing us with a strong value foundation.

Speaker #4: Our intention is to build on that aggressively and we have made good progress recently toward that end. At Easel, we present an interim phase one 2A data for ARROWHEAD INHBE and obesity and MASH, and the results were compelling.

Speaker #4: ARROWHEAD INHBE achieved dose-dependent active E reductions, with a mean maximum reduction of over 85% after a single 400-milligram dose, with effects persisting beyond three months.

Chris Anzalone: ARO-INHBE achieved dose-dependent active and E reductions with a mean maximum reduction over 85% after a single 400-milligram dose, with effects persisting beyond 3 months. In a small subgroup with obesity and elevated baseline liver fat receiving at least 200 milligrams as monotherapy, the placebo-adjusted post-dose reduction in liver fat was 44%. The program has been generally well-tolerated, and we're now engaging regulators on potential phase II designs and endpoints. We continue to make progress in the ARO-ALX007 phase I/II program and expect to release more data from that study in Q4. Further, we expect to file a CTA for a new obesity candidate against an undisclosed target by the end of this year. Our June cardiometabolic R&D webinar highlighted plozasiran and ARO-PNPLA3.

Speaker #4: In a small subgroup with obesity and elevated baseline liver fat, receiving at least 200 milligrams as monotherapy, the placebo-adjusted post-dose reduction in liver fat was 44%.

Speaker #4: The program has been generally well tolerated, and we're now engaging regulators on potential Phase 2 designs and endpoints. We continue to make progress in the Arrowhead ALK-7 Phase 1/2 program and expect to release more data from that study in the fourth quarter.

Speaker #4: Further, we expect to file a CTA for a new obesity candidate against the undisclosed target by the end of this year. Our June cardiometabolic R&D webinar highlighted pozasteran, zodasteran, and ARO-DMYR PA.

Speaker #4: The zodasteran Yosemite phase three study in HOF patients is fully enrolled and we expect to have data in Q3, 2027, and hopefully file an NDA by the end of 2027.

Chris Anzalone: zodasiran USEMBY phase III study in HoFH patients is fully enrolled, and we expect to have data in Q3 2027 and hopefully file an NDA by the end of 2027. ArrowDyr PA is designed to silence both APOC3 and PCSK9 and therefore reduce both LDL cholesterol and triglycerides. We believe this could be a uniquely powerful therapy for roughly 20 million people in the United States with both elevated LDL and triglycerides. We expect to release early data from our phase I study in September. During the quarter, we also presented our subcutaneous CNS delivery work around ARO-MAPT at TIDES.

Speaker #4: Aerodymer PA is designed to silence both APOC3 and PCSK9, and therefore reduce both LDL cholesterol and triglycerides. We believe this could be a uniquely powerful therapy for the roughly 20 million people in the United States with both elevated LDL and triglycerides.

Speaker #4: We expect to release early data from our Phase 1 study in September. During the quarter, we also presented our subcutaneous CNS delivery work around ARROWHEAD MAP-T at TIDES.

Speaker #4: This is an important piece of our pipeline, and we expect to release early data from our phase one study in September. This is a potentially exciting dataset not only because of the potential of ARROWHEAD MAP-T against Alzheimer's disease and other childhood disease, but also because we think it could provide the first clinical proof of concept that we are able to address brain targets with RNAi using a simple subcutaneously administered conjugate.

Chris Anzalone: We expect to release early data from our phase I study in September. This is a potentially exciting data set, not only because of the potential of ARO-MAPT against Alzheimer's disease and other geographies, but also because we think it could provide the first clinical proof of concept that we are able to address brain targets with RNAi using a simple subcutaneously administered conjugate. Our partnership strategy remains a key part of our model and value proposition. In May, we announced an exclusive worldwide license agreement with Madrigal for ARO-PNPLA3, a program for a genetically defined MASH population. Phase I data showed liver fat reductions of up to 46% after a single dose in homozygous carriers of the PNPLA3 I148M variant with rapid onset durability through at least 24 weeks and no clinically meaningful adverse events observed.

Speaker #4: Our partnership strategy remains a key part of our model and value proposition. In May, we announced an exclusive worldwide license agreement with Madrigal for ARROWHEAD-P and PLA3, a program for a genetically defined MASH population.

Speaker #4: Phase one data showed liver fat reductions of up to 46% after a single dose in homozygous carriers of the P and PLA 3 I148M variant with rapid onset durability through at least meaningful adverse events observed.

Speaker #4: Under the agreement, Arrowhead received a $25 million upfront payment and is eligible for up to $975 million in development, regulatory, and sales milestones, and tiered royalties in the mid-teens.

Chris Anzalone: Under the agreement, Arrowhead received a $25 million upfront payment and is eligible for up to $975 million in development, regulatory, and sales milestones and tiered royalties to mid-teens. We believe that Arrowhead is something truly unique in biotech today. We have an approved product and positive pivotal data that we believe supports a potentially much larger indication that we think could drive peak sales in the $3 to 4 billion per year range. We have commercial infrastructure that is effective, growing, and capable of being the basis for multiple additional products. We have a set of platforms that enable us to address liver, adipose, muscle, lung, and CNS targets, and we believe virtually everything we have introduced to the clinic has translated from animal models to humans.

Chris Anzalone: Under the agreement, Arrowhead received a $25 million upfront payment and is eligible for up to $975 million in development, regulatory, and sales milestones and tiered royalties to mid-teens. We believe that Arrowhead is something truly unique in biotech today. We have anapproved product and positive pivotal data that we believe supports a potentially much larger indication that we think could drive peak sales in the $3 to 4 billion per year range. We have commercial infrastructure that is effective, growing, and capable of being the basis for multiple additional products. We have a set of platforms that enable us to address liver, adipose, muscle, lung, and CNS targets, and we believe virtually everything we have introduced to the clinic has translated from animal models to humans.

Speaker #4: We believe that ARROWHEAD is something truly unique in biotech today. We have an approved product and positive pivotal data that we believe supports a potentially much larger indication that we think could drive peak sales in the three to four billion dollars per year range.

Speaker #4: We have commercial infrastructure that is effective, growing, and capable of being the basis for multiple additional products. We have a set of platforms that enable us to address liver, adipose, muscle, lung, and CNS targets, and we believe virtually everything we have introduced to the clinic has translated from animal models to humans.

Speaker #4: By the end of this year, we expect to have 23 individual drug candidates in clinical trials, 11 wholly owned, 12 partnered, and we have a high degree of confidence that the overwhelming majority of these could eventually be approved products.

Chris Anzalone: By the end of this year, we expect to have 23 individual drug candidates in clinical trials, 11 wholly owned, 12 partnered, and we have a high degree of confidence that the overwhelming majority of these could eventually be approved products. We have the potential for substantial future partner income from milestones and royalties, and we have the financial resources to keep this engine running and growing. As you look to the patients we can help and the value we can create, of course, look to zodasiran, but also look to the engine we have built and the dozens of new medicines we can bring to patients. With that overview, I'd now like to turn the call over to Andy Davis. Andy?

Speaker #4: We have the potential for substantial future partner income from milestone royalties, and we have the financial resources to keep this engine running and growing.

Speaker #4: So as you look to the patients, we can help, and the value we can create of course look to pozasteran. But also look to the engine we have built and the dozens of new medicines we can bring to patients.

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

Speaker #3: Thank you, Chris, and good afternoon, everyone. It has now been approximately eight and a half months since the FDA approval of REDEMPFLO last November, and we continue to be very pleased with the progress of the launch.

Andy Davis: Thank you, Chris. Good afternoon, everyone. It has now been approximately eight and a half months since the FDA approval of REDEMPLO last November, and we continue to be very pleased with the progress of the launch. Today, I'd like to first walk through where we stand with our FCS launch. First, prescription and patient dynamics. Second, payer coverage. Third, pricing and competitive positioning. Fourth, commercial infrastructure. Fifth, international expansion. Finally, turn to some reflections on our recent SHTG clinical trial results. Let's start with prescription and patient dynamics. REDEMPLO prescription volume has more than doubled over the course of the fiscal Q3, and that momentum has continued into the current quarter. We have supported more than 400 unique prescribers of REDEMPLO, with the specialty mix continuing to be led by preventive cardiology and endocrinology, consistent with prior quarters and our expectations at launch.

Speaker #3: Today, I'd like to first walk through where we stand with our FCS launch. First, prescription and patient dynamics. Second, payer coverage. Third, pricing and competitive positioning.

Speaker #3: Fourth, commercial infrastructure. And fifth, international expansion. And then finally, I'll turn to some reflections on our recent SHTG clinical trial results. Let's start with prescription and patient dynamics.

Speaker #3: REDEMPFLO prescription volume has more than doubled over the course of the fiscal third quarter, and that momentum has continued into the current quarter. We have supported more than 400 unique prescribers of REDEMPFLO.

Speaker #3: The specialty mix continues to be led by preventive cardiology and endocrinology, consistent with prior quarters and our expectations at launch. Patient origination remains steady from prior communications across new-to-therapy versus switch patients, and the volume of physicians writing prescriptions and patients receiving REDEMPFLO for FCS continues to exceed our internal targets.

Andy Davis: Patient origination remains steady from prior communications across new-to-therapy versus switch patients. The volume of physicians writing prescriptions and patients receiving REDEMPLO for FCS continues to exceed our internal targets. In recent market tracking studies, healthcare professional respondents indicate steadily increasing awareness and depth of product knowledge with consistently high marks for REDEMPLO, both in absolute terms and relative to competition. Turning now to payer coverage developments. We continue to see strong momentum in the publication of payer policies and overall coverage across payer segments. REDEMPLO now has favorable policies in place for the most significant payers, and overall coverage is progressing at a fast trajectory for the brand. We expect the remaining coverage gap to continue closing over the coming months.

Speaker #3: In recent market tracking studies, healthcare professional respondents indicate steadily increasing awareness and depth of product knowledge with consistently high marks for REDEMPFLO, both in absolute terms and relative to developments, we continue to see strong momentum in the publication of payer policies and overall coverage across payer segments.

Speaker #3: REDEMPFLO now has favorable policies in place for the most significant payers and overall coverage is progressing at a fast trajectory for the brand. We expect the remaining coverage gap to continue closing over the coming months.

Speaker #3: Our market access team remains focused on ensuring both genetically confirmed and clinically diagnosed FCS patients have access to REDEMPFLO in nearly all published payer policies reflect the ability for physicians to diagnose FCS patients using clinical criteria alone.

Andy Davis: Our market access team remains focused on ensuring both genetically confirmed and clinically diagnosed FCS patients have access to REDEMPLO. Nearly all published payer policies reflect the ability for physicians to diagnose FCS patients using clinical criteria alone. Next, pricing and competitive positioning. As a reminder, REDEMPLO's US WAC is $45,000 per patient per year under our one REDEMPLO unified pricing model. We believe the value of REDEMPLO is supported by its highly differentiated efficacy, safety profile, and dosing convenience. We've said consistently that we believe REDEMPLO offers physicians and patients a best-in-class option. We remain confident that both the clinical data and the commercial model we've built position us well in FCS as we head towards the potential launch in SHTG.

Speaker #3: Next, pricing and competitive positioning. As a reminder, REDEMPFLO's US WACC is 45,000 US dollars per patient per year, under our one REDEMPFLO unified pricing model, and we believe the value of REDEMPFLO is supported by its highly differentiated efficacy, safety profile, and dosing convenience.

Speaker #3: We've said consistently that we believe REDEMPFLO offers physicians and patients a best-in-class option, and we remain confident that both the clinical data and the commercial model we've built position us well in FCS as we head towards the potential launch in SHTG.

Speaker #3: Ultimately, we believe physicians and patients should have the freedom to choose the therapy that best fits a given patient's clinical profile and will continue to let the product profile of REDEMPFLO and FCS make our case.

Andy Davis: Ultimately, we believe physicians and patients should have the freedom to choose the therapy that best fits a given patient's clinical profile. We will continue to let the product profile of REDEMPLO and FCS make our case. On our commercial infrastructure, our field organization continues to scale in a deliberate, sequenced way, sized for both the current FCS opportunity and the future SHTG opportunity as it unfolds. Our commercial team's tenure and productivity continue to build. We're seeing that reflected in the prescription and payer metrics I just walked through. Importantly, if the launch timing for SHTG is accelerated, as we expect, we will be ready. Just this past week, in fact, we onboarded the next wave of field personnel. This team will be in the field this month educating stakeholders on FCS and REDEMPLO. Lastly, a word about international expansion.

Speaker #3: On our commercial infrastructure, our field organization continues to scale in a deliberate sequenced way sized for both the current FCS opportunity and the future SHTG opportunity as it unfolds our commercial teams tenure and productivity continue to build and we're seeing that reflected in the prescription and payer metrics I just walked through.

Speaker #3: Importantly, if the launch timing for SHTG is accelerated as we expect, we will be ready. Just this past week, in fact, we onboarded the next wave of field personnel.

Speaker #3: This team will be in the field this month educating stakeholders on FCS and REDEMPFLO. Lastly, a word about international expansion: REDEMPFLO has now been approved for FCS in the United States, Canada, China, Australia, and the European Union.

Andy Davis: REDEMPLO is now approved for FCS in the United States, Canada, China, Australia, and the European Union. On the EU approval specifically, REDEMPLO's label uniquely covers both genetically confirmed and clinically diagnosed FCS patients. That is to say, it is the only therapy in Europe with clinical FCS on label. We view this as a meaningful differentiator, given that a substantial share of real-world FCS patients are diagnosed clinically rather than genetically. We expect reimbursement will proceed on a country-by-country basis over approximately the next 12 months, beginning with Germany in the coming weeks. I will wrap up my remarks with some reflections on what is ahead for plozasiran and SHTG. As Chris highlighted, we recently announced top-line results from the Phase III SHASTA-3 and SHASTA-4 studies of plozasiran in severe hypertriglyceridemia, and we believe these are best-in-class results.

Speaker #3: On the EU approvals specifically, REDEMPFLO's label uniquely covers both genetically confirmed and clinically diagnosed FCS patients. That is to say, it's the only therapy in Europe with clinical FCS on label.

Speaker #3: We view this as a meaningful differentiator given that a substantial share of real-world FCS patients are diagnosed clinically rather than genetically. We expect reimbursement will proceed on a country-by-country basis over approximately the next 12 months.

Speaker #3: Beginning with Germany in the coming weeks. I'll wrap up my remarks with some reflections on what's ahead for pozasteran and SHTG. As Chris highlighted, we recently announced top-line results from the Phase 3 SHASTA-III and SHASTA-IV studies of pozasteran in severe hypertriglyceridemia, and we believe these are best-in-class results.

Speaker #3: Both studies met their primary endpoint, with median triglyceride reductions of 79% and 81% from baseline at month 12 in SHASTA III and SHASTA IV, respectively, compared to approximately 27% for placebo.

Andy Davis: Both studies met their primary endpoint, with median triglyceride reductions of 79% and 81% for baseline at month 12 in SHASTA-3 and SHASTA-4, respectively, compared to approximately 27% for placebo. Just as importantly, in the pre-planned pooled analysis, plozasiran achieved a statistically significant reduction in acute pancreatitis events versus placebo across the broad SHTG population study, a 78% reduction in cumulative AP events. And in the subset of patients at the very highest risk, those with triglycerides above 880 milligrams per deciliter and a prior history of pancreatitis, we saw a 100% reduction in AP events versus placebo. The safety and tolerability profile remained consistent with what we have seen across the plozasiran program to date, with no new safety signals, no clinically meaningful liver findings, and no hypersensitivity or thrombocytopenia signal.

Speaker #3: Just as importantly in the pre-planned pooled analysis, pozasteran achieved a statistically significant reduction in acute pancreatitis events versus placebo across the broad SHTG population study, a 78% reduction in cumulative AP events.

Speaker #3: And in the subset of patients at the very highest risk, those with triglycerides above 880 milligrams per deciliter and a prior history of pancreatitis we saw a 100% reduction in AP events versus placebo.

Speaker #3: The safety and tolerability profile remained consistent with what we've seen across the pozasteran program to date, with no new safety signals, no clinically meaningful liver findings, and no hypersensitivity or thrombocytopenia signal.

Speaker #3: We see this data set as a powerful validation of pozasteran's profile across the full spectrum of SHTG, and it gives us continued confidence in our planned supplemental NDA submission, which remains on track for before the end of this year.

Andy Davis: We see this data set as a powerful validation of plozasiran's profile across the full spectrum of SHTG, and it gives us continued confidence in our planned supplemental NDA submission, which remains on track for before the end of this year. With that, I will turn the call over to James.

Speaker #3: With that, I'll turn the call over to James.

Speaker #2: Thank you, Andy. I'd like to share our plans for R&D milestones and data readouts throughout the rest of the year. But first, let's review the R&D team's accomplishments over the last quarter and beyond.

James Hamilton: Thank you, Andy. I would like to share our plans for R&D milestones and data readouts throughout the rest of the year. First, let us review the R&D team's accomplishments over the last quarter and beyond. We made large strides in advancing our cardiometabolic programs, specifically the Arrowhead team mock databases and analyzed data for MUIR-3, SHASTA-3, and SHASTA-4 ahead of schedule, culminating in the release of top-line SHASTA-3 and SHASTA-4 data at the end of last month. As already mentioned, plozasiran achieved deep and durable reductions in triglycerides, translating into statistically significant reduction in acute pancreatitis events. Plozasiran also demonstrated a favorable safety profile with no statistically significant difference in liver fat in the treatment group versus placebo. We remain excited about sharing detailed results which are planned for presentation at the upcoming European Society of Cardiology meeting later this month.

Speaker #2: We made large strides in advancing our cardiometabolic programs, specifically the AROWHEAD team lot databases and analyzed data for MIR3, SHASTA III, and SHASTA IV ahead of schedule, culminating in the release of top-line SHASTA III and SHASTA IV data at the end of last month.

Speaker #2: As already mentioned, pozasteran achieved deep and durable reductions in triglycerides, translating into a statistically significant reduction in acute pancreatitis events. Pozasteran also demonstrated a favorable safety profile, with no statistically significant difference in liver fat in the treatment group versus placebo.

Speaker #2: We remain excited about sharing detailed results, which are planned for presentation at the upcoming European Society of Cardiology meeting later this month. The MIR3 trial achieved its intended purpose as a study designed to build the pozasteran safety database.

James Hamilton: The MUIR-3 trial achieved its intended purpose as a study designed to build the plozasiran safety database. We plan on presenting data from this study at a future medical conference. During the quarter, plozasiran received Australian and European Commission approval as an adjunct to diet in FCS patients. Switching gears to zodasiran in the development for the treatment of homozygous familial hypercholesterolemia, or HoFH, we completed enrollment of the Phase III study in mid-July. Importantly, the study was designed to enroll 60 HoFH patients. However, due to strong demand, we ended up enrolling 70 patients, all with genetically confirmed or clinically defined HoFH. This is a one-year study, so we expect study completion mid-2027, with data in H2 2027. In cardiometabolic, the ArrowDimer PA Phase I/IIa study in patients with mixed hyperlipidemia is nearing full enrollment, and we plan to share top-line data in September.

Speaker #2: We plan on presenting data from this study at a future medical conference. Additionally, during the quarter, pozasteran received Australian and European Commission approval as an adjunct to diet in FCS patients.

Speaker #2: Switching gears to zodasteran, in the development for the treatment of homozygous familial hypercholesterolemia, or HOFH, we completed enrollment of the phase three Yosemite study in mid-July.

Speaker #2: Importantly, the study was designed to enroll 60 HoFH patients. However, due to strong demand, we ended up enrolling 70 patients, all with defined HoFH.

Speaker #2: This is a one-year study, so we expect study completion mid-2027 with data in the second half of '27. Also, in cardiometabolic, the AROWDIMER PA phase one 2A study in patients with mixed hyperlipidemia is nearing full enrollment, and we plan to share top-line data in September.

Speaker #2: Elsewhere in our pipeline, we continue to make progress with both the ARO-HIF2 and the ARO-ANG3 and the ARO-ALK7 programs. As Chris already highlighted, we presented data from the ARO-HIF2 and ARO-ANG3 phase 1 study demonstrating a 44% reduction in liver fat in patients with hepatic steatosis at baseline.

James Hamilton: Elsewhere in our pipeline, we continue to make progress with both the ARO-INHBE and the ARO-ALK7 programs. Chris already highlighted, we presented data from the ARO-INHBE Phase I study demonstrating a 44% reduction in liver fat in patients with hepatic steatosis baseline. A reminder, liver fat reductions of better than 30% are generally thought to translate into histologic and potentially clinical benefit. An ARO-INHBE Phase IIb clinical trial protocol has been submitted to regulators. The trial is designed to evaluate the effects of various doses of ARO-INHBE on liver fat, liver histology, body weight, and body composition in obese patients with MASH. The study is intended to evaluate diabetic and non-diabetic patients, as well as those on and not on stable incretin therapy. The study is under regulatory review, we plan on sharing trial details once agreed upon with regulators.

Speaker #2: As a reminder, liver fat reduction is a better than 30% or generally thought to translate into histologic and potentially clinical benefit. And AROW and HIV and E phase two B clinical trial protocol has been submitted to regulators; the trial is designed to evaluate the effects of various doses of AROW and HIV and E on liver fat, liver histology, body weight, and body composition in obese patients with NASH.

Speaker #2: The study is intended to evaluate diabetic and non-diabetic patients as well as those on and not on stable increedin therapy. As the study is under regulatory review, we plan on sharing trial details once agreed upon with regulators.

Speaker #2: We intend to provide an obesity data update primarily focused on ALK7 towards the end of this year. Moving on to CNS, we've long held the belief that the CNS represents the next frontier for siRNA therapeutics.

James Hamilton: We intend to provide an obesity data update primarily focused on ALK7 towards the end of this year. Moving on to CNS. We've long held the belief that the CNS represents the next frontier for siRNA therapeutics, with a large number of gene targets amenable to a gene-silencing approach. Historically, the field has been severely limited by the requirement of intrathecal administration. This is a limitation Arrowhead hopes to remove with pioneering technology designed to deliver siRNA therapeutics across the blood-brain barrier. ARO-MAPT is Arrowhead's first molecule based on this delivery platform. MAPT gene encodes for the tau protein. Abnormal tau accumulation is widely believed to be a critical component of the pathologic cascade leading to Alzheimer's disease. Other forms of abnormal tau accumulation are known to directly cause MAPT variant frontotemporal dementia, as well as progressive supranuclear palsy.

Speaker #2: With a large number of gene targets amenable to a gene silencing approach, historically the field has been severely limited by the requirement of intrathecal administration.

Speaker #2: This is a limitation Arrowhead hopes to remove with pioneering technology designed to deliver siRNA therapeutics across the blood-brain barrier. AROWMAT-T is Arrowhead's first molecule based on this delivery platform.

Speaker #2: The MAT-T gene encodes for the tau protein. An abnormal tau accumulation is widely believed to be a critical component of the pathologic cascade leading to Alzheimer's disease.

Speaker #2: Additionally, other forms of abnormal tau accumulation are known to directly cause MAT-T variant frontotemporal dementia, as well as progressive supranuclear palsy. A Phase 1 clinical trial of AROWMAT-T in healthy volunteers is reaching full enrollment, and the second phase of this study in Alzheimer's patients is actively enrolling.

James Hamilton: A Phase I clinical trial of ARO-MAPT in healthy volunteers is reaching full enrollment, and the second phase of this study in Alzheimer's patients is actively enrolling. Chris mentioned, we are targeting this September for top-line data release from the healthy volunteers. This will be a very important data readout as it could pave the way for later-stage tauopathy clinical trials. Achieving successful MAPT gene silencing will validate the platform for use in numerous additional CNS programs in our pre-clinical pipeline, which includes our partnered programs. I will now turn the call over to Dan Apel.

Speaker #2: As Chris mentioned, we are targeting this September for a top-line data release from the healthy volunteers. This will be a very important data readout, as it could pave the way for later-stage tauopathy clinical trials. Additionally, achieving successful MAT-T gene silencing will validate the platform for use in numerous additional CNS programs in our preclinical pipeline, which includes our partnered programs.

Speaker #2: I will now turn the call over to Daniel Apel.

Speaker #3: Thank you, James, and good afternoon, everyone. As we reported today, net loss for the quarter in the June 30, 2026 was $194.3 million. Or loss of $1.36 per share based on $143.4 million fully diluted weighted average shares outstanding.

Dan Apel: Thank you, James, and good afternoon, everyone. As we reported today, net loss for the quarter ended 30 June 2026 was $194.3 million, or a loss of $1.36 per share based on 143.4 million fully diluted weighted average shares outstanding. This compares to a net loss of $175.2 million, or a loss of $1.26 per share for the prior year quarter ended 30 June 2025, based on $139 million fully diluted weighted average shares outstanding in that quarter. Revenue for the quarter totaled approximately $75 million compared to $28 million in the prior year quarter. Revenue was driven by our license and collaboration agreements with Sarepta, Madrigal, Novartis, and Sanofi, together with commercial sales of REDEMPLO. Of the total, approximately $26 million related to the Sarepta collaboration, mainly from ongoing recognition of initial consideration under that agreement, as well as reimbursement of certain clinical and manufacturing expenses.

Speaker #3: This compares to a net loss of $175.2 million, or a loss of $1.26 per share, for the prior year quarter ended June 30, 2025, based on 139.0 million fully diluted weighted average shares outstanding in that quarter.

Speaker #3: Revenue for the quarter totaled approximately $75.0 million compared to $28.0 million in the prior year quarter. Revenue was driven by our license and collaboration agreements with Sarepta, Madrigal, Novartis, and Sanofi, together with commercial sales of Odempo.

Speaker #3: Of the total, approximately $26.0 million related to the Sarepta collaboration. Mainly from ongoing recognition of initial consideration under that agreement, as well as reimbursement of certain clinical and manufacturing expenses.

Speaker #3: For the Novartis collaboration, we recognize approximately $20.0 million in the quarter. Bringing fiscal year-to-date revenue recognition to approximately $75.0 million. As of June 30 of the initial $200.0 million of cash received upfront, approximately $125.0 million of consideration remains in deferred revenue and will be recognized over time as we fulfill our pre-clinical research and development obligations.

Dan Apel: With the Novartis collaboration, we recognized approximately $20 million in the quarter, bringing fiscal year-to-date revenue recognition to approximately $75 million. As of 30 June, of the initial $200 million of cash received upfront, approximately $125 million of consideration remains in deferred revenue and will be recognized over time as we fulfill our pre-clinical research and development obligations. We also recognized the full $25 million upfront payment from Madrigal following completion of a license and technology transfer for ARO-PNPLA3. As previously announced, Arrowhead remains eligible to receive up to $975 million in development, regulatory, and sales milestones, as well as tiered royalties on future commercial sales ranging from the high single digits to the mid-teens. Finally, we recognized approximately $1.2 million for transitional services and commercial FCS supply to Sanofi under our license agreement for Greater China.

Speaker #3: We also recognize the full $25.0 million upfront payment from Madrigal following completion of a license and technology transfer for AROW PNP LA3. As previously announced, AROWHEAD remains eligible to receive up to $975.0 million in development, regulatory, and sales milestones as well as tiered royalties on future commercial sales ranging from the high single digits to the mid-teens.

Speaker #3: Finally, we recognize the approximately $1.2 million for transitional services and commercial FCS supply to Sanofi under our license agreement for Greater China. As previously mentioned, we are not intending to headline specific Odempo product sale numbers until they become a meaningful driver to our financials.

Dan Apel: As previously mentioned, we are not intending to headline specific REDEMPLO product sale numbers until they become a meaningful driver to our financials. That said, commercial revenue can be derived from our disclosures as a difference between total revenue and collaboration revenue and represented approximately $2.4 million for the quarter. This has more than doubled the approximately $1 million recorded in fiscal Q2, and we have been very encouraged by the continued progress we are seeing in launch. Turning now to expenses. Total operating expenses for the quarter were approximately $245 million compared to $193 million in the prior year quarter. The $52 million year-over-year increase was driven by approximately $36 million of higher R&D expense and $16 million of higher SG&A expense. R&D expense was approximately $198 million.

Speaker #3: That said, commercial revenue can be derived from our disclosures as the difference between total revenue and collaboration revenue, and represented approximately $2.4 million for the quarter.

Speaker #3: This is more than double the approximately $1.0 million recorded in fiscal quarter two, and we have been very encouraged by the continual progress we are seeing in launch.

Speaker #3: Turning now to expenses, total operating expenses for the quarter were approximately $245 million, compared to $193 million in the prior year quarter. The $52 million year-over-year increase was driven by approximately $36 million of higher R&D expense and $16 million of higher SG&A expense.

Speaker #3: R&D expense was approximately $198.0 million. The increase year-over-year was primarily attributed to a $32.0 million increase in candidate costs pipelined through clinical development, including the Phase 3 registration program for plozasiran in SHCG, as well as increased manufacturing and clinical supply activity.

Dan Apel: The increase year-over-year was primarily attributed to a $32 million increase in candidate costs, reflecting continued progression of our pipeline through clinical development, including the phase III registrational program for plozasiran in SHTG, as well as increased manufacturing and clinical supply activity. In line with our forecast, this also contributed to the pickup in expenses when compared to fiscal Q2. Salaries were also higher, driven by increased headcount to support manufacturing operations and a broader clinical pipeline. As James discussed, SHASTA-3 and SHASTA-4 have now read out with positive top-line results. Accordingly, we expect costs associated with active execution of those studies to begin to moderate down over time beginning in fiscal 2027. At the same time, we will continue to invest in regulatory activities, commercial supply readiness for potential SHTG launch, and advancement of our broader pipeline.

Speaker #3: In line with our forecast, this also contributed to the uptick in expenses when compared to fiscal quarter two. Salaries were also higher, driven by increased headcount to support manufacturing operations and a broader clinical pipeline.

Speaker #3: As James discussed, both the 3 and the 4 have now read out with positive top-line results. Accordingly, we expect costs associated with active execution of those studies to begin to moderate down over time, beginning in fiscal 2027.

Speaker #3: At the same time, we will continue to invest in regulatory activities, commercial supply readiness, or potential SHCG launch and advancement of our broader pipeline so quarterly R&D expense will continue to be highly influenced by program timing and clinical activity.

Dan Apel: The quarterly R&D expense will continue to be highly influenced by program timing and clinical activity. SG&A expense was approximately $47 million in the quarter compared to $31 million in the prior year quarter. The increase was primarily driven by ongoing investments supporting the commercialization of REDEMPLO, including commercial headcount, marketing and launch support, and other outside services. Given the opportunities we are seeing in FCS, we have expanded and are continuing to expand our commercial footprint and our capabilities where appropriate. We're building these capabilities to support the current FCS launch, but we've designed them to scale, supporting potential future indications for plozasiran and ultimately zodasiran in HoFH. Turning to the balance sheet. Cash and investments on hand totaled approximately $1.6 billion as of 30 June 2026.

Speaker #3: SG&A expense was approximately $47.0 million in the quarter, compared to $31.0 million in the prior-year quarter. The increase was primarily driven by ongoing investments supporting the commercialization of Odevmpo, including commercial headcount, marketing and launch support, and other outside services.

Speaker #3: Given the opportunities we are seeing in FCS, we have expanded and are continuing to expand our commercial footprint and our capabilities where appropriate. We're building these capabilities to support the current FCS launch, but we've designed them to scale, supporting potential future indications for Plasoster and, ultimately, Sudoster in HoFH.

Speaker #3: Turning to the balance sheet, cash and investments on hand totaled approximately $1.6 billion as of June 30, 2026, common shares outstanding at quarter end were $141.1 million.

Dan Apel: Common shares outstanding at quarter end were 141.1 million. As we have disclosed, we have entered into an asset purchase agreement for an issued FDA priority review voucher, which we plan to use with our upcoming sNDA submission for plozasiran in SHTG. Under the terms of the APA, we will pay the current holder $215 million at closing, which we expect to occur in our fiscal Q4 following HSR clearance. According to our projections, should we gain approval in SHTG, the increase in present value of REDEMPLO simply as a result of shifting our launch aspirations and uptake curve forward by four months, provides a greater than 3x return on the PRV investment. Further, it is easy to layer on top of that incremental value that we might expect to achieve commercially should we be able to shorten our competitor's first-mover advantage.

Speaker #3: As we have disclosed, we have entered into an asset purchase agreement for an issued FDA priority review voucher which we plan to use with our upcoming SNDA submission for plasoster in SHCG.

Speaker #3: Under the terms of the APA, we will pay the current holder $215 million at closing, which we expect to occur in our fiscal fourth quarter following HSR clearance.

Speaker #3: According to our projections, should we gain approval in SHCG, the increase in present value of Odempo simply as a result of shifting our launch aspirations and uptake curve forward by four months provides a greater than 3x return on the PR and PRV investment.

Speaker #3: Further, it is easy to layer on top of that incremental value that we might expect to achieve commercially should we be able to shorten our competitors' first move advantage.

Speaker #3: As a concluding remark, we believe our strong balance sheet provides significant financial flexibility to support ongoing clinical development, current and future commercialization activities, and our long-term strategic priorities.

Dan Apel: As a concluding remark, we believe that our strong balance sheet provides significant financial flexibility to support ongoing clinical development, current and future commercialization activities, and our long-term strategic priorities. With that brief overview, I will now turn the call back to Chris.

Speaker #3: With that brief overview, I will now turn the call back to Chris.

Speaker #2: Thanks, Dan. We've made so much progress during the first half of the year, and the second half of 2026 is equally packed with potentially important and value-creating events.

Chris Anzalone: Thanks, Dan. We've made so much progress during the H1 of the year, and the H2 of 2026 is equally packed with potentially important and value-creating events. First, we want to move as quickly as possible to get our sNDA submitted for plozasiran, supported by the strong clinical data from the SHASTA-3 and SHASTA-4 studies. The priority review voucher we acquired, it could help us get this important new medicine to patients with SHTG as rapidly as possible. Physicians and patients are eagerly anticipating this medicine, so we are working hard to make it happen. Beyond plozasiran, we have some important data readouts and events planned before the end of the year that could represent important de-risking and potential value-creating events. These readouts include the following.

Speaker #2: First, we want to move as quickly as possible to get our SNDA submitted for plasoster in supported by the strong clinical data from the Shasta III and Shasta IV studies.

Speaker #2: The priority review voucher we acquired could help us get this important new medicine to patients with SHCG as rapidly as possible. Physicians and patients are eagerly anticipating this medicine, so we are working hard to make it happen.

Speaker #2: Beyond plosenosterin, we have some important data readouts and events planned before the end of the year that could represent significant de-risking and potential value-creating events.

Speaker #2: These readouts include the following: one, the first clinical readout of Aerodymer PA, the first dual functional siRNA candidate targeting both PCSK9 and APOC3 for LDL and TG lowering is expected in September.

Chris Anzalone: One, the first clinical readout of ARROW-1006PA, the first dual-functional siRNA candidate targeting both PCSK9 and APOC3 for LDL and TG lowering, is expected in September. Two, the first clinical readout for ARO-MAPT, being developed as a potential treatment for tauopathies, including Alzheimer's disease, representing our first program using the subcutaneously administered CNS delivery platform designed across the blood-brain barrier after systemic delivery. This is expected in September. Three, additional ARO-INHB and ARO-AB7 data releases are planned in Q4 for this novel non-inhibition strategy, which has quite encouraging early data in obesity and MASH. With that, thank you for joining us today, and I would now like to open the call to your questions. Operator?

Speaker #2: Two, the first clinical readout for AeromapT being developed as a potential treatment for tauopathies including Alzheimer's disease, representing our first program using the subcutaneously administered CNS delivery platform designed across the blood-brain barrier after systemic delivery.

Speaker #2: This is expected in September. And three, additional AeroINHBE and AeroALP7 data releases are planned in the fourth quarter for this novel non-encryption strategy which has quite encouraging early data in obesity and NASH.

Speaker #2: With that, thank you for joining us today, and I would now like to open the call to your questions. Operator?

Speaker #1: Thank you. At this time, we will conduct the question and answer session. As a reminder to ask a question, you'll need to press star 11 on your telephone and wait for your name to be announced.

Operator: Thank you. At this time, we will 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 limit one question per person. Please stand by while we compile the Q&A roster. Our first question comes from Maury Raycroft from Jefferies. Your line is now open.

Speaker #1: To withdraw your question, please press star 11 again. Please limit to one question per person. Please stand by while we compile the Q&A roster. Our first question comes from Maury Ray Kroff from Jefferies.

Speaker #1: Your line is now open.

Maury Raycroft: Hi. Congrats on the progress and on the SHASTA data, and thanks for taking my question. With a question on just the sNDA, getting that submitted by year-end 2026, can you bookend what that timeline could look like and what the gating factors are for getting that in? Separately, can you talk about expectations for the ESC late-breaker data? There has been some debate on median versus mean TG reduction magnitude, and even though there are no static differences on safety, were there any imbalances in liver fat, LP elevations, or glycemic parameters you want to comment on?

Speaker #4: Hi. Congrats on the progress and on the Shasta data and thanks for taking my question. With a question on just the SNDA, getting that submitted by year-end 26, can you bookend what that timeline could look like and what the gating factors are for getting that in?

Speaker #4: And separately, can you talk about expectations for the ESC Late Breaker data? There's been some debate on median versus mean TG reduction magnitude, and even though there are no static differences on safety, were there any imbalances in liver fat, ALT elevations, or glycemic parameters you want to comment on?

Speaker #3: Yeah, sure. Maury, this is James. I'll answer the second question. The ESC data you'll have to wait and see. At ESC, we really are under embargo until the conference, so we can't discuss any details around the study.

James Hamilton: Yeah, sure. Maury, this is James. I will answer the second question. The ESC data, you will have to wait and see at ESC. We really are under embargo until the conference, so cannot discuss any details around the study. In terms of rate limiters for the sNDA, we do plan to have a pre-sNDA meeting with FDA, then subsequent to our discussions with the agency, would file the submission. For the time being, for our team, it is really all about generating sNDA modules and study reports and whatnot, and finalizing the data that we need for the filing by the end of the year.

Speaker #3: In terms of rate limiters for the SNDA, we do plan to have a pre-SNDA meeting with FDA and then subsequent to our discussions with the agency, would file the submission.

Speaker #3: So for the time being, for our team, it's really all about generating SNDA modules and study reports and whatnot, and finalizing the data that we need for the.

Speaker #3: And by the end of the year.

Speaker #4: Got it. Okay. Thanks for taking my questions.

Maury Raycroft: Got it. Okay. Thanks for taking my questions.

Speaker #1: Thank you. One moment for our next question. Our next question comes from Mike Oltz from Morgan Stanley. Your line is now open.

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

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

Mike Oltz: Good afternoon. Thanks for taking the question, and congratulations on all the progress as well. Maybe just one on ARO-MAPT. Just if you can remind us what top-line data you might share with us in September and what level of knockdown are you looking for, and has that sort of evolved at all now that we've seen some of the Biogen data? Thanks.

Mike Ulz: Good afternoon. Thanks for taking the question, and congratulations on all the progress as well. Maybe just one on ARO-MAPT. Just if you can remind us what top-line data you might share with us in September and what level of knockdown are you looking for, and has that sort of evolved at all now that we've seen some of the Biogen data? Thanks.

Speaker #4: Good afternoon. Thanks for taking the question and congratulations on all the progress as well. Maybe just one on AeromapT. Just if you can remind us what top line data you might share with us in September and what level of knockdown are you looking for and has that sort of evolved at all now that we've seen some of the biogen data.

Speaker #4: Thanks.

Speaker #3: Yeah, sure. I can take that one also. So this will only be healthy volunteer data. We'll be discussing primarily safety and then total tau knockdown.

Chris Anzalone: Yeah, sure. I can take that one also. This will only be healthy volunteer data. We'll be discussing primarily safety and then total tau knockdown. There's not a lot of other biomarkers that we can measure in the healthies

Speaker #3: There's not a lot of other biomarkers that we can measure in the healthies. So it's just safety and pharmacodynamic dose range finding study. In the healthies, and then sorry, what was the other part of the question?

James Hamilton: It's just safety and pharmacodynamic dose range finding study in the healthies. Sorry, what was the other part of the question? What knockdown was?

Chris Anzalone: Oh, yeah. I think that we're still aiming for probably that 50% to 60% knockdown. That level of knockdown seemed to achieve some level of clinical improvements in the CELIA study. I think we've said that all along, and we're sticking with that benchmark of 50% to 60% knockdown.

Speaker #3: Oh, yeah. So I think that we still we're still aiming for probably that 50 to 60 percent knockdown. I mean, that level of knockdown seemed to achieve some level of clinical improvement in the Celia study.

Speaker #3: So I think we've said that all along, and we're kind of sticking with that benchmark of 50 to 60 percent knockdown.

Speaker #4: Thanks. And congrats again.

Mike Oltz: Thanks, congrats again.

Mike Ulz: Thanks, congrats again.

Speaker #1: Thank you. One moment for our next question. Our next question comes from Brian Chang from JPMorgan. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from Brian Cheng from J.P. Morgan. Your line is now open.

Speaker #5: Hey, guys. Thanks for kicking out questions. And let us at our congrats into the on the Shasta data. Early in the call, you talk about the sequencing scale up of your Salesforce.

Brian Cheng: Hey, guys. Thanks for taking our questions and let us add our congrats on the SHASTA data. Early in the call, you talk about the sequencing scale-up of your sales force. How big of a sales force do you envision that you'll need to reach, and how does that sequence look over the course of the next several months heading into the label expansion decision? Thank you.

Speaker #5: I'll think of a Salesforce to envision that you'll need to reach, and how that sequence looks over the course of the next several months heading into the label expansion decision.

Speaker #5: Thank you.

Speaker #3: Thanks, Brian. This is Andy. Good question. Well, I won't go into the details of the size of our field force for SHTG. I would tell you that we'll be moving from effectively addressing over 5,000 HCP targets to a world where we'll be addressing over 20,000 HCP targets across both the specialists that I've mentioned previously and also potentially those primary care physicians who act like specialists.

Andy Davis: Thanks, Brian. This is Andy. Good question. While I won't go into the details of the size of our field force for SHTG, I would tell you that we'll be moving from effectively addressing over 5,000 HCP targets to a world where we'll be addressing over 20,000 HCP targets across both the specialists that I've mentioned previously and also potentially those primary care physicians who act like specialists. We would anticipate the final onboarding of the optimization of our field force to happen before the end of the year as we prepare for a potential accelerated launch in SHTG in the Q2 of next year.

Speaker #3: So, we would anticipate the final onboarding of the optimization of our field force to happen before the end of the year, as we prepare for a potential accelerated launch in SHTG in the second quarter of next year.

Speaker #5: Thanks, guys.

Brian Cheng: Thanks, guys.

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

Speaker #1: Our next question. Our next question comes from Luca Izzy from RBC. Your line is now open.

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

Luca Issi: Oh, great. Yeah, thanks so much for taking my question. Congrats on all the progress. Maybe a quick one for James again. You're not commenting on whether there is or there's not a trend in terms of increase a little liver fat, again, rightly so, given that the data's still embargoed at ESC. Maybe can you remind us what proportion of all patients in SHASTA 3 and SHASTA 4 actually received an MRI at baseline in year 1? Just trying to understand what's the sample size here and how meaningful that analysis will be. That'll be much appreciated. Maybe super quickly, now that you have SHASTA 3 and SHASTA 4 in-house, how should we be thinking about SHASTA 5? Will you still continue that trial or maybe will you wind that down? Any thoughts there? Much appreciated. Thanks so much.

Speaker #6: Oh, great. Yeah. Thanks so much for taking my question. Congrats on the progress. Maybe quick one for James again. Again, you're not commenting on whether there is or there's not a trend in terms of increasing liver fat.

Speaker #6: Again, rightly so, given that the data is still embargoed at ESC. But maybe can you remind us what proportion of all patients in Shasta 3 and Shasta 4 actually received an MRI at baseline in year one?

Speaker #6: Just trying to understand what's the sample size here and how meaningful that analysis will be so that there'll be much appreciated. And then maybe super quickly, now that you have Shasta 3 and Shasta 4 in-house, how should we be thinking about Shasta 5?

Speaker #6: Will you still continue that trial or maybe will you wind that down? Any thoughts there? Much appreciated. Thanks so much.

Speaker #3: Yeah, sure. Thanks, Luca. So for the initial question, like I said before, we're under embargo. I can't really give any details around the Shasta 3 or Shasta 4 study, but we'll present all of that at ESC for Shasta 5.

James Hamilton: Yeah, sure. Thanks, Luca. For the initial question, like I said before, we're under embargo. I can't really give any details around the SHASTA 3 or SHASTA 4 study, but we'll present all of that at ESC. For SHASTA 5, we don't have any plans to terminate that study right now. The plan would be to continue that and maybe get a better idea of what our label's going to look like before we make any decisions to stop the study. For the time being, it's kind of status quo. We're continuing to enroll that study and continuing to run the study without any changes.

Speaker #3: We don't have any plans to terminate that study right now. The plan would be to continue that and maybe get a better idea of what our labels are going to look like before we make any decisions to stop the study.

Speaker #3: So for the time being, it's kind of status quo. We're continuing to enroll that study and continuing to run the study without any changes.

Speaker #6: Got it. Thank you, guys.

Luca Issi: Got it. Thank you, guys.

Speaker #1: Thank you. One moment for our next question. Our next question comes from Jason Gerberry from Bank of America. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from Jason Gerberry from Bank of America. Your line is now open.

[Analyst] (Bank of America): Hi, good afternoon. This is Dina on for Jason. Congrats on the progress this quarter. Thank you so much for taking our question. Just the first one is on REDEMPLO and SHTG. Just curious if you guys have a view on which TG responder analysis you view as maybe more important for establishing that REDEMPLO is a very strong TG lowering. Is it below that 500 threshold or below that 150? Just a second one, if I could squeeze it in. Will your priority review voucher allow you to get Medicare Part D coverage for REDEMPLO for most of 2027, or is it just the second half of 2027? Thanks.

Speaker #7: Hi, good afternoon. This is Dina on for Jason. Congrats on the progress this quarter, and thank you so much for taking our question. Just the first one is on Redemplo and SHTG.

Speaker #7: Just curious if you guys have a view on which TG responder analysis you view as maybe more important or establishing that Redemplo is a very strong TG lowering?

Speaker #7: Is it below that 500 threshold or below that 150? And then just a second one, if I could squeeze it in. While your priority review voucher allow you to get part D coverage for Redemplo for most of 2027, or is it just the second half of 2027?

Speaker #7: Thanks.

James Hamilton: I'll take the first question around responder analysis. Again, going to have to wait until ESC to see the actual data on the responder analysis. For SHTG, 500 vis per deciliter is the threshold. It's thought to be below that. You should reduce the risk for acute pancreatitis, which is really where we're focused with the drug right now.

Speaker #3: I'll take the first question around responder analysis. I mean, again, you're going to have to wait until ESC to see the actual data on the responder analysis.

Speaker #3: But I mean, for SHTG, 500 weeks per deciliter is the threshold, and it's thought to be below that. You should reduce the risk for acute pancreatitis, which is really where we're focused with the drug right now.

Speaker #2: Yeah. I think both 150 and 500 are important. It's our goal to get as many below 500 as possible. But certainly, if we can normalize a large percentage of these patients, that's a very attractive tool for physicians.

Andy Davis: Yeah, I think both 150 and 500 are important. It's our goal to get as many below 500 as possible. Certainly, if we can normalize a large percentage of these patients, that's a very attractive tool for physicians.

Speaker #2: And on the, sorry, what was the question on the priority voucher?

James Hamilton: Sorry, what was the question on the priority voucher?

[Analyst] (Bank of America): If your PRV will allow you to get Part D coverage for most of 2027? Or is it just the H2 of the year, more towards the end of the year?

Speaker #7: If your PRV will allow you to get part D coverage for most of 2027, or is it just the second half of the year, like more towards the end of the year?

Speaker #3: Yeah, so Dina, as we normally would, we'll be pursuing both payer policies and coverage for SHTG as rapidly as possible. Our market access team, as soon as the data is published in the coming month or so, will be interacting with payers to inform them of the data and prepare for eventual policy development and coverage throughout 2027.

Andy Davis: Yeah. Dina, as we normally would, we will be pursuing both payer policies and coverage for SHTG as rapidly as possible. Our market access team, as soon as the data is published in the coming month or so, will be interacting with payers to inform them of the data and prepare for eventual policy development and coverage throughout 2027.

Speaker #7: Thank you very much.

[Analyst] (Bank of America): Thank you very much.

Speaker #1: Thank you. One moment for our next question. Our next question comes from Joseph Tome from TD Cohen. 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 #8: Hi, there. Good afternoon. Congrats on the progress and thank you for taking my question. For the SHTG market, how would you see the difference in prescribing between the US and European markets or any changes in practice guidelines between the two that we should be thinking about?

Joseph Thome: Hi there. Good afternoon. Congrats on the progress and thank you for taking my question. For the SHTG market, how do you see the difference in prescribing between the US and European markets, or any changes in practice guidelines between the two that we should be thinking about? Maybe of that $3 to 4 billion range that you indicated for plozasiran, how much of that is US-based versus international markets? Thank you.

Speaker #8: And maybe of that $3 to $4 billion range that you indicated for Pozasta, how much of that is US-based versus international markets? Thank you.

Speaker #2: Yeah, I'll take the easy question. The second question—the majority of that is the United States, the overwhelming majority of that. Andy, you want to take it?

Chris Anzalone: Yeah, I'll take the easy question. The second question. The majority of that is the United States. The overwhelming majority of that. Andy, you want to take that?

Andy Davis: Yeah. This is Andy. As far as European market dynamics versus US market dynamics related to triglycerides and acute pancreatitis, both are extremely important. These markets from a payer perspective are very outcomes-based, so the fact that we demonstrated a statistically significant reduction in the pooled analysis for phase III SHASTA-3 and phase III SHASTA-4 is incredibly important to demonstrating value in the European markets. Those healthcare practitioners in Europe recognize that AP and ongoing AP is a function of elevated triglycerides and whether or not you have a prior history of AP. That's the same as the healthcare providers in the United States as well.

Speaker #6: Yeah. And then this is Andy. As far as European market dynamics versus US market dynamics related to triglycerides and acute pancreatitis, both are extremely important.

Speaker #6: These markets, from a payer perspective, are very outcomes-based. So the fact that we demonstrated a statistically significant reduction in the pooled analysis for Shasta 3 and Shasta 4 is incredibly important to demonstrating value in the European markets.

Speaker #6: But those healthcare practitioners in Europe recognize that AP and ongoing AP is a function of elevated triglycerides. And whether or not you have a prior history of AP and so that's the same as the healthcare providers in the United States as well.

Chris Anzalone: We'll be the 65th company to tell you that given the uncertainty around MFN, it's very difficult for us to, at this point, to know how these are going to be pursued in ex-US markets and what kind of revenue we're going to see from outside the US markets.

Speaker #2: But we'll be the 65th company to tell you that given the uncertainty around MFN, it's very difficult for us to, at this point, to know how these are going to be pursued in XUS markets and what kind of revenue we're going to see from outside the US markets.

Andy Davis: We'll be the 65th company to tell you that given the uncertainty around MFN, it's very difficult for us to, at this point, to know how these are going to be pursued in ex-US markets and what kind of revenue we're going to see from outside the US markets.

Speaker #8: Perfect. Thank you.

Joseph Thome: Perfect. Thank you.

Operator: Thank you. One moment for our next question. Our next question comes from James Coldus from Stifel. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from James Condulis from Stifel. Your line is now open.

Speaker #1: Thank you. One moment for our next question. Our next question comes from James Coldis from Stifel. Your line is now open.

James Coldus: Hey, thanks for taking my question and congrats on all the progress. Maybe one on trigs and just specifically as it relates to sort of your expectations around the commercial opportunity. With your data out there now, the Ionis launch is sort of underway. Just wanted to get your latest on kind of how we should be thinking about what the right analogs are here and maybe more specifically, how important you think the initial quarters for this class are to sort of validating or reading onto the size of the overall opportunity here. Thanks so much.

James Condulis: Hey, thanks for taking my question and congrats on all the progress. Maybe one on trigs and just specifically as it relates to sort of your expectations around the commercial opportunity. With your data out there now, the Ionis launch is sort of underway. Just wanted to get your latest on kind of how we should be thinking about what the right analogs are here and maybe more specifically, how important you think the initial quarters for this class are to sort of validating or reading onto the size of the overall opportunity here. Thanks so much.

Speaker #5: Hey. Thanks for taking my question and congrats on all the progress. Maybe one on Craig's and just specifically as it relates to sort of your expectations around the commercial opportunity.

Speaker #5: With your data out there now, the Ionis launch is sort of underway. Just wanted to get your latest on kind of how we should think how we should be thinking about what the right analogs are here.

Speaker #5: And maybe more specifically, how important you think the initial quarter's for this class are to sort of validating or reading onto the size of the overall opportunity here.

Speaker #5: Thanks so much.

Speaker #6: Yeah, happy to take that. This is Andy. And I mean, as with any launch, of course, you want to get out of the gates quickly.

Andy Davis: Yeah, happy to take that. This is Andy. As with any launch, of course, you want to get out of the gates quickly. We'll be hyper-focused on ensuring that our providers are well-educated on the value of REDEMPLO in SHTG. We'll also simultaneously, of course, be working with payers to get policies published and coverage in place in order to accelerate the ramp of REDEMPLO in SHTG. As you would know, there's a high degree of overlap between those prescribers who are writing for familial chylomicronemia syndrome and those who will also write for SHTG. These are, of course, those who have an interest in lipidology. There are about 1,500 of those individuals in the United States across specialties. We think the ramp that we're seeing in FCS bodes well for the ramp we would expect to see in SHTG also.

Speaker #6: So we'll be hyper-focused on ensuring that our providers are well-educated on the value of Redemplo and SHTG. And we'll also simultaneously, of course, be working with payers to get policies published and coverage in place in order to accelerate the ramp of Redemplo and SHTG.

Speaker #6: As you would know, there's a high degree of overlap between those prescribers who are writing for familial kylomicronemia syndrome and those who will also write for SHTG.

Speaker #6: These are, of course, those who have an interest in lipidology. There are about 1,500 of those individuals in the United States across specialties. So, we think the ramp that we're seeing in FCS bodes well for the ramp we would expect to see in SHTG, also.

Chris Anzalone: I'll give you a qualitative answer also. Look, we think that SHTG is a very large market opportunity. There is an awful lot of patients who have triglycerides that we really need to help get under control. We are convinced of that. Our KOLs are convinced of that. However, this is going to be a relatively slow wrench because this is a brand-new market. We are in the education business. It is going to take a bit of time for us to get the word out because look, the world is not used to looking at TGs closely in part at least because there have been no good ways to really reduce triglycerides until now. This is all a good thing for patients. It is just going to take a bit of time to educate those patients and educate physicians.

Speaker #2: And I'll give you a qualitative answer also. Look, we think that SHTG is a very large market opportunity. There's an awful lot of patients who have triglycerides that we really need to help get under control.

Speaker #2: We're convinced of that. Our KOLs are convinced of that. However, this is going to be a relatively slow ramp because this is a brand new market.

Speaker #2: We are in the education business. And so it's going to take a bit of time for us to get the word out. Because look, the world is not used to looking at TGs closely because there have been in part, at least because there have been no good ways to really reduce triglycerides until now.

Speaker #2: And so this is all a good thing for patients to just going to take a bit of time to educate those patients and educate physicians.

Speaker #5: Makes sense. Thanks.

James Coldus: Makes sense. Thanks.

James Condulis: Makes sense. Thanks.

Speaker #1: Thank you. One moment for our next question. Our next question comes from Madison Elsadi. From B. Riley Securities, your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from Madison Elsadi from B. Riley Securities. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from Madison El-Saadi from B. Riley Securities. Your line is now open.

Speaker #8: Hi guys. Congrats on the progress and thanks for taking a question here. Maybe how should we think about the doubling of Redemplo prescriptions? I guess in terms of weekly run rate, I think 30 per week, maybe was the last disclosure you guys put out.

Madison Elsadi: Hi, guys. Congrats on the progress and thanks for taking our question here. Maybe how should we think about the doubling of REDEMPLO prescriptions, I guess, in terms of weekly run rate? I think 30 per week maybe was the last disclosure you guys put out. Relatedly, has the prescription to drug in DC-to-RF conversion rate kind of hit the steady state for FCS? If not, just what are the drivers there? Secondly, if I can quickly, for ESC, I know you are under embargo, so just a general question. Do you expect the learnings there are more academic in nature, or is it something that really facilitates a naive cross-trial comparison and really informs the label? Thanks.

Madison El-Saadi: Hi, guys. Congrats on the progress and thanks for taking our question here. Maybe how should we think about the doubling of REDEMPLO prescriptions, I guess, in terms of weekly run rate? I think 30 per week maybe was the last disclosure you guys put out. Relatedly, has the prescription to drug in DC-to-RF conversion rate kind of hit the steady state for FCS? If not, just what are the drivers there? Secondly, if I can quickly, for ESC, I know you are under embargo, so just a general question. Do you expect the learnings there are more academic in nature, or is it something that really facilitates a naive cross-trial comparison and really informs the label? Thanks.

Speaker #8: And then relatedly, has the prescriptions to drug and arm conversion rate kind of hit the steady state for FCS? And if not, kind of just what are the drivers there?

Speaker #8: And then secondly, if I can quickly, for ESC—I know you're under embargo—so just a general question: do you expect the learnings there are more academic in nature?

Speaker #8: Or is it something that really kind of facilitates a naive cross-trial comparison and really kind of informs the label things?

Speaker #6: Yeah. Hi, Madison. This is Andy again. Thanks for your question. Yeah. We do see approximately 20 to 30 new prescriptions a week that has been the run rate and consistent with what we had communicated previously.

Andy Davis: Hi, Madison. This is Andy again. Thanks for your question. We do see approximately 20 to 30 new prescriptions a week. That has been the run rate and consistent with what we had communicated previously. Of course, our teams are very focused on also ensuring that those prescriptions find their way through the funnel, ultimately to shipments to patients. Our market access team is working incredibly hard to support our payer and our physicians and offices around compliantly navigating the prior authorization process and appeal process. As I mentioned, we will have new field personnel in the field educating stakeholders as early as this month. I would expect to see also an inflection point both in prescriptions at the top of the funnel, but also in the way those prescriptions filter through the funnel to ultimately those patient shipments.

Speaker #6: Of course, our teams are very focused on also ensuring that those prescriptions find their way through the funnel ultimately to shipments to patients and so our market access team is working incredibly hard to support our payer and our physicians and offices around compliantly navigating the prior authorization process and appeal process.

Speaker #6: But as I mentioned, we will have new field personnel in the field educating stakeholders as early as this month. And so I would expect to see an inflection point both in prescriptions at the top of the funnel, but also in the way those prescriptions filter through the funnel to ultimately those patient shipments.

Andy Davis: On the ESC question, again, I'm just real hesitant to make any additional comments on the data just given the embargo. We'll see at the end of the month.

Speaker #2: And on the ESC question, again, I'm just real hesitant to make any additional comments on the data, just given the embargo. So you'll see at the end of the month.

Andy Davis: On the ESC question, again, I'm just real hesitant to make any additional comments on the data just given the embargo. We'll see at the end of the month.

Madison Elsadi: Sounds good. Thanks, guys.

Madison El-Saadi: Sounds good. Thanks, guys.

Speaker #8: Sounds good. Thanks.

Speaker #1: Thank you. One moment for our next question. Our next question comes from Patrick Tortucci from HC Wainwright. Your line is now open.

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

Speaker #7: Hi everyone, thank you for taking our questions. This is Luis. For Patrick, we're thinking about the launch in SHTG. Will it be in the highest risk patients?

[Analyst] (H.C. Wainwright): Hi, everyone. Thank you for taking our questions. This is Luis in for Patrick. We're thinking about the launch in the SHTG. Will it be in the highest-risk patients? Will it be segmented to the highest-risk patients, or more broadly across patients with TGs above 500? The question is directed at how would this reflect on the commercial builds? Would it be a step function or would it be an incremental expansion of the existing FCS field force?

Speaker #7: Will it be segmented to the highest risk patients, or more broadly across patients with triglycerides above 500? And the question is directed at how would this reflect on the commercial bills?

Speaker #7: Would it be a step function or would it be an incremental expansion of the existing FCS field force?

Speaker #6: Yeah. Thanks for your question. This is Andy. Certainly, while we think the top-line results support Redemplo across the spectrum of SHTG patients, naturally, we'll be focused on those high-risk SHTG patients out of the gate.

Andy Davis: Yeah. Thanks for your question. This is Andy. Certainly, while we think the top-line results support REDEMPLO across the spectrum of SHTG patients, naturally we'll be focused on those high-risk SHTG patients out of the gate. These are, of course, those patients who have the highest unmet need in the view of healthcare professionals and also the highest willingness to pay by payers. So that'll be our initial focus at launch. As far as scaling of the field force, as I mentioned, we did implement effectively a step function increase in the field force that will go into the field this month and we'll continue to look to optimize our field force as we head towards SHTG. Let's be clear. I think that our data suggests that it is important to get people's triglycerides down if they have triglyceride levels above 500, full stop.

Speaker #6: These are, of course, those patients who have the highest unmet need in the view of healthcare professionals, and also the highest willingness to pay by payers.

Speaker #6: And so that'll be our initial focus at launch. As far as scaling of the field force, as I mentioned, we did implement effectively a step function increase in the field force.

Speaker #6: That will go into the field this month and we'll continue to look to optimize our field force as we head towards SHTG.

Speaker #2: And let's be clear: I think that our data suggests that it is important to get people's triglycerides down if they have triglyceride levels above 500—full stop.

Speaker #2: We had people who had triglycerides below 880 who had episodes of pancreatitis. I think that's important. So while we think that that population at greatest risk is going to be the initial market, there is a broader market to address here that I think is important and their patients that need to be treated.

Andy Davis: We had people who had triglycerides below 880 who had episodes of pancreatitis. I think that's important. So while we think that that population at greatest risk is going to be the initial market, there is a broader market to address here that I think is important and there are patients that need to be treated. Again, as I mentioned earlier, this is going to be an education play and it's just going to take a bit of time to help physicians and patients understand the risk here.

Speaker #2: But again, as I mentioned earlier, this is going to be an education play and it's just going to take a bit of time to help physicians and patients understand the risk here.

[Analyst] (H.C. Wainwright): Great. Thank you. Congratulations.

Speaker #7: Great. Thank you. And congratulations.

Speaker #2: Thank you.

Andy Davis: Thank you.

Speaker #1: Thank you. One moment for our next question. Our next question comes from Kay from Chart & Capital Markets. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from Keay from Chardan Capital Markets. Your line is now open.

Speaker #7: Hi, thank you. Now that you have your data, how are you thinking about the price differential versus Trengoza?

[Analyst] (Chardan Capital Markets): Hi. Thank you. Now that you have your data, how are you thinking about price differential versus Tryngolza?

Keay Nakae: Hi. Thank you. Now that you have your data, how are you thinking about price differential versus Tryngolza?

Speaker #6: Yeah. This is Andy. So I won't go into price details or contracting strategy, only to say that you would be aware of the wholesale acquisition cost for Redemplo 45,000 US dollars per year.

Andy Davis: Yeah. This is Andy. I won't go into price details or contracting strategy, only to say that you would be aware of the wholesale acquisition cost for REDEMPLO of $45,000 per year. That does differ from our competitor and we've communicated previously that we believe that premium is justified based on the product attributes of REDEMPLO across efficacy, safety, and convenience. If the question is, do we intend to move that price now that we have these data? The answer is no. We believe this is the right price for this drug. We think that there is real reason to price this at a slight premium to our competitor given what we see as a better safety profile, a better reduction in triglycerides from baseline, a simpler approach with quarterly dosing rather than a monthly dosing.

Speaker #6: That does differ from our competitor, and we've communicated previously that we believe the premium is justified based on the product attributes of Redemplo across efficacy, safety, and convenience.

Speaker #2: If the question is, do we intend to move that price now that we have these data? The answer is no. We believe this is the right price for this drug.

Speaker #2: We think that there is real reason to price this at a slight premium to our competitor, given what we see as a better safety profile, a better reduction in triglycerides from baseline, a simpler approach with quarterly dosing rather than monthly dosing, and a lack of need to—well, we believe—a lack of need to follow more enzymes, because we haven't seen those issues.

Andy Davis: We believe a lack of need to follow liver enzymes because we just haven't seen those issues and a simple 25 mg dose for all patients rather than having to titrate up.

Speaker #2: And a simple 25 milligram dose for all patients rather than having to titrate up.

Speaker #7: Okay. Thanks.

[Analyst] (Chardan Capital Markets): Okay. Thanks.

Keay Nakae: Okay. Thanks.

Speaker #1: Thank you. One moment for our next question. Our next question comes from Jen Jai from Cantor Fitzgerald. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from Jenn Jia from Cantor Fitzgerald. Your line is now open.

Operator: Thank you. One moment for our next question. Our next question comes from Jennifer Jia from Cantor Fitzgerald. Your line is now open.

Jennifer Jia: Hi, this is Jennifer Jia for Caroyu. Congrats on the SHP results. For the neuro programs, what other CNS targets are you excited about if the phase I/II for MAPT is positive?

Speaker #5: Hi. This is Jennifer Jett for our alcohol. Congrats on the shots and results. So for the NEURO programs, what other CMS targets are you excited about if the phase one and two for MAPT is positive?

James Hamilton: Are you asking what other gene targets are we interested in?

Speaker #2: Are you asking what other gene targets are we interested in?

Jennifer Jia: Yes. For knockdown. If the MAPT works out.

Speaker #5: Yes. Yes. For knockdown. If the MAPT works out.

Speaker #2: Sure. So, we have a lot of different targets. We haven't disclosed any of those. And in terms of wholly owned programs, we probably won't disclose those until around the time of CTA filing, just given the competitive nature in the siRNA space right now.

James Hamilton: Sure. We have a lot of different targets. We haven't disclosed any of those. In terms of wholly owned programs, we probably won't disclose those until around the time of the CTA filing, just given the competitive nature in the siRNA space right now. Stay tuned.

Speaker #2: So stay tuned.

Speaker #5: Great. Thank you.

Jennifer Jia: Great. Thank you.

Speaker #1: Thank you. One moment for our next question. Edward, 10 off from Piper Sandlers is our next question. Your line is now open.

Operator: Thank you. One moment for our next question. Edward Tenthoff from Piper Sandler is our next question. Your line is now open.

Edward Tenthoff: Great. Thank you very much. I just wanted to retreat a little bit and go back through sort of what the plans are for marketing now that you're approved in US, Canada, Australia, and Europe. Are you directly marketing in each of those or are you using distributors? Are you going to recognize revenues from each of those geographies and then pay out a distributor fee in SG&A? I just want to understand those dynamics more. Thank you.

Speaker #7: Great. Thank you very much. I just wanted to retreat a little bit and go back through sort of what the plans are for marketing now that you're approved in US, Canada, Austria, Australia, and Europe.

Speaker #7: Are you directly marketing in each of those? And how or are you using distributors? And how does are you going to recognize revenues from each of those geographies and then pay out a distributor fee and SCNA?

Speaker #7: Just want to understand those dynamics more. Thank you.

Chris Anzalone: Thanks for the question, Edward. Good question. This is Andy again. We are marketing into those countries that you mentioned using commercial partners. Redemplo is not out-licensed nor have we established distributor relationships in those markets. It's effectively Arrowhead in operation with our commercial partners in those markets that you mentioned, with the exception of China.

Speaker #2: Thanks for the question, Edward. Good question. This is Andy again. So we are marketing into those countries that you mentioned using commercial partners. So Redemplo is not out-licensed, nor have we established distributor relationships in those markets.

Speaker #2: It's effectively Arrowhead in operation with our commercial partners. In those markets that you mentioned with the exception of China.

Edward Tenthoff: In terms of revenue recognition?

Speaker #7: And in terms of revenue recognition?

Edward Tenthoff: In terms of revenue recognition?

Speaker #3: So in terms of revenue recognition, it just follows the standard. So this is Dan here. It follows the standard revenue recognition. So as we complete a sale to customers in those countries, we would recognize revenue.

Dan Apel: In terms of revenue recognition, it would just follow the standard. Sorry, this is Dan here. Follow the standard revenue recognition. As we complete a sale to customers in those countries, we would recognize revenue. Nothing unique in that regard.

Speaker #3: So nothing unique or in that regard.

Edward Tenthoff: Is it a net revenue or is there a fee that's paid in SG&A? Thanks so much.

Speaker #7: Is it a net revenue, or is there a fee that's paid in SCNA? Thanks so much.

Speaker #3: Oh, yeah. No, it's a I mean, it's similar to the US, so it would be a gross sale. And then in the gross to net, you have to deduct out sort of distribution costs and the like.

Dan Apel: Oh, yeah. No, it's similar to the US, it'll be a gross sale, and then in the gross to net, you have to deduct out sort of distribution costs and the like. If you're asking about the cost to support that's being offered by our commercial partners there, which is kind of like a contract marketing, contract sales, that would show up in marketing and sales costs. That would now be part of net.

Speaker #3: But if you're asking about the cost to support that has been offered by our commercial partners there, which is kind of like a contract marketing contract sales, that would show up in marketing and sales costs.

Speaker #3: So that would not be part of it.

Speaker #7: Right. That's super helpful, Dan. Thanks, guys. And keep up.

Edward Tenthoff: Super helpful, Dan. Thanks, guys, and keep it up.

Speaker #2: Thanks, Ed.

Chris Anzalone: Thanks, Ed.

Operator: This concludes the question and answer session. I would now like to turn the call back to Chris and Nazali for closing remarks.

Operator: This concludes the question and answer session. I would now like to turn the call back to Chris Anzalone for closing remarks.

Speaker #1: This concludes the question and answer session. I would now like to turn the call back to Chris and the Zolli only for closing remarks.

Speaker #2: Thanks very much for joining us today. And we look forward to speaking with you later in August. After ESC and then in September around the era DARPA disclosures as well as in MAPT.

Chris Anzalone: Thanks very much for joining us today. We look forward to speaking with you later in August after ESC, then in September around the ARROWDABRA PA disclosures, as well as in MAPT. Have a great summer.

Speaker #2: Have a great summer.

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

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