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.

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. With us today for management, our president and CEO, Dr. Chris Anzalone, who will provide an overview. Andy Davis, senior vice president and head of the global cardiometabolic franchise, who will provide an update on commercialization activities. Dr. James Hamilton, chief medical officer and head of R&D, who will discuss our development programs. and Dan Appel, Chief Financial Officer, who will give a review of the financials. 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 meeting of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. 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. Thanks, Vince. Good afternoon, everyone, and thank you for joining us today. AeroVet 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 hypercubusoridemia, or SHTG, and we expect additional results to be presented later this month at the European Society of Cardiology Conference. These data made clear to us that Redempla was 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 six 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. Let's talk about the Chasset 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 eruptions 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 PDFS subgroup, there was no statistically significant difference in mean liver fat content between plisacirin and placebo. The acute pancreatitis findings are, in our view, the standout results. 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 placebo. And in the highest risk subgroup, patients with triglycerides above 880 milligrams per deciliter 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 August 30th, followed by an Arrowhead webcast on August 31st. We intend to submit an FNDA to the FDA before the end of 2026, followed by additional global findings. 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. We believe the Shasta results materially de-risk our most important near-term label expansion opportunity and further strengthen the foundation of our cardiovascular franchise. As we consider how we could fit into SHTG therapeutic paradigms, we think of Redempla 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 Chasta III and IV across multiple measures, including quiet liver enzymes, no hypersensitivity, and no increase in liver fat. 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. And strong, because of unprecedented reductions in triglyceride levels from baseline across multiple sites. We see this as a clearly compelling value proposition for patients, healthcare providers, and payers, therefore the speed of which we can bring POSASER into the broader SHCG population is critical the possibility of shaving four months off the approval process through the primary 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 U.S. or depth low launch for FCS continued to build real momentum during the quarter. We've seen greater than doubling 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. 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. 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 revemplo an approved footprint across five geographies an important achievement we are very proud of 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 Prozaceran to SHTG patients, but also to serve as the basis for our broader cardiometabolic franchise, which we especially include Zodaceran, Aerodymer PA, 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 for Zastoran 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 present an interim phase 1-2a data for Aero-I and HBE in obesity and mash and the results were compelling. Aero-I and HBE achieved dose dependent active and e-reductions with a mean maximum reduction over 85% after a single 400 milligram dose with effects persisting beyond three months. In a small subgroup with obesity and elevated baseline liver fat receiving at least 200 milligrams of asthma therapy, 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 AeroAlc7 Phase I-II program and expect to release more data from that study in the fourth quarter. 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 Zodacirane, Zodacirane and Aerodimer PA. The Zodacirane Yosemite Phase III 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. Aerodimer PA is designed to sinus 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 AROMAP-T at TIDES. 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 data set not only because of the potential of AROMAP-T against Alzheimer's disease and other challenges, 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 Aero PNPLA-3, a program for a genetically defined mass population. Phase I data showed liver fat reductions of up to 46% after a single dose in homozygous carriers of the PNPLA-3 I-148M variants with rapid onset durability through at least 24 weeks and no clinically meaningful adverse events observed. Under the agreement, Aero had 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. 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 a substantial future partner income for our milestones and royalties and we have the financial resources to keep this engine running and growing. So as you look to the patients we can help and the value we can create of course look to but also look to the engine we have built and the dozens of new medicines we can bring to patients. With that overview I now I'd like to turn the call over to Andy Davis. Andy. Thank you, Chris, and good afternoon, everyone. It has now been approximately eight and a half months since the FDA approval of Redempla 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, and fifth, international expansion. And then finally, turn to some reflections on our recent SHTG clinical trial results. Let's start with prescription and patient dynamics. Redempla 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 Redempla, with the specialty mix continuing to be led by preventive cardiology and endocrinology, consistent with prior quarters and our expectations at lunch. Patient origination remains steady from prior communications across new-to-therapy-versus-switched patients, and 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 Redemplu, 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. Redempla 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. Our market access team remains focused on ensuring both genetically confirmed and clinically diagnosed FCS patients have access to Redempla, and 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 US dollars per patient per year under our one Redemplo unified pricing model, and 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, 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. Ultimately, we believe physicians and patients should have the freedom to choose the therapy that best fits a given patient's clinical profile, and we'll continue to let the product profile of Redemplot and FCS make our case. On our commercial infrastructure, our field organization continues to scale in a deliberate sequenced way, size for both the current FCS opportunity and the future SHTG opportunity as it unfolds. Our commercial team's tenure and productivity continued to build and 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 SDS and Redemblow. Lastly, a word about international expansion. 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's 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'll wrap up my remarks with some reflections on what's ahead for plizasterine and SHTG. As Chris highlighted, we recently announced top-line results from the Phase 3 Shasta 3 and Shasta 4 studies of plizasterine and severe hypotricidyseridemia, and we believe these are best-in-class results. 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 a pre-planned pooled analysis, plisacerin achieved a statistically significant reduction in acute pancreatitis events versus placebo across the broad SHTG population study, a 78% reduction in cumulative of 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've seen across the plizasterin program to date, with no new safety signals, no clinically meaningful liver findings, and no hypersensitivity or thrombocytopenia signal. We see this data set as a powerful validation of Plisasterin'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'll turn the call over to Tim. 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. We made large strides in advancing our cardiometabolic programs. Specifically, the Arrowhead team mocked databases and analyzed data for MIR-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, plozaceran achieved deep and durable reductions in triglycerides, translating into statistically significant reduction in acute pancreatitis events. Plozaceran 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. The MIR-3 trial achieved its intended purpose as a study designed to build the Plozaceran safety database. We plan on presenting data from this study at a future medical conference. Additionally, during the quarter, plizaceran received Australian and European Commission approval as an adjunct to diet in FCS patients. Switching gears to zodaceran in the development for the treatment of homozygous familial hypercholesterolemia, or HOFH, we completed enrollment of the Phase III Yosemite 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 the second half of 27 also in cardiometabolic the AeroDimerPA Phase 1-2A study in patients with mixed hyperlipidemia is nearing full enrollment and we plan to share top-line data in September. Elsewhere in our pipeline we continue to make progress with both the AeroInhibit-E and the AeroAlk7 programs. As Chris already highlighted, we presented data from the AeroInhibit-E Phase 1 study demonstrating a 44% reduction in liver fat in patients with hepatic steatosis baseline as a reminder liver fat reductions of better than 30% are generally thought to translate into histologic and potentially clinical benefit an arrow inhibiting phase 2b clinical trial protocol has been submitted to regulators the trial is designed to evaluate the effects of various doses of arrow inhibiting 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 increment therapy as the study is under regulatory review we plan on sharing trial details once agreed upon with regulators we tend to provide an obesity data update primarily focused on elk 7 towards the end of this year moving on to CNS we've long held the belief that the CNS represents the next frontier for sRNA 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 sRNA therapeutics across the blood-brain barrier arrow map T is arrowhead's first molecule based on this delivery platform map T 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 additionally other forms of abnormal tau accumulation are known to directly cause map T variant frontotemporal dementia as well as progressive supernucleate palsy. A phase one clinical trial of ARROMAP-T in Healthy Volunteers is reaching full enrollment and the second phase of this study in Alzheimer's patients is actively enrolling. As 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 telepathy clinical trials. Additionally, achieving Having successful NAPT 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 Danico.

Thank you, James, and good afternoon, everyone. As we reported today, net loss for the quarter into 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. This compares to a net loss of 175.2 million or loss of $1.26 per share for the prior year quarter and to June 30, 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, Madrico, Novartis, and Sanofi, together with commercial sales of Adempo. 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 with the Novartis collaboration we recognize approximately 20 million in the quarter bringing fiscal year-to-date revenue recognition to approximately 75 million as of June 30th 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 preclinical research and development obligation. We also recognize the full $25 million upfront payment from Madrigal following completion of a license and technology transfer for Arrow PMP-LA3. 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-team. Finally, we recognized 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 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 is more than double the approximately $1 million recorded in Fiscal Quarter 2, and we have been very encouraged by the continued progress we are seeing in lunch. 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. 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 Registration Program for Plesoster and NSHCG, as well as increased manufacturing and clinical supply activity. In line with our forecast, this also contributed to the pick-up in expenses when compared to Fiscal Quarter II. Salaries are also higher given 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, or potential SHCG launch, and advancement of a broader pipeline. The quarterly R&D expense will continue to be highly influenced by program timing, clinical activity. SG&A expense was approximately $47 million in the quarter, compared to $31 million in the prior quarter. The increase is primarily driven by ongoing investments, supporting the commercialization of Redempo, 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 plizoceran and ultimately sudoceran and HOFH. 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. 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 plizasterin in SHCG. Under the terms of the APA, we will pay the current holder $215 million in closing, which we expect to occur in our fiscal fourth quarter following HSR clearance. According to our projections, should we gain approval in SHCG, the increase in present value of Redemplum, simply as a result of shifting our launch aspirations and uptake curve forward by four months, provides a greater than 3x return on the PRB 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 competitors' first-moved advantage. 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.

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. First, we want to move as quickly as possible to get our SNDA-submitted for Plisacirin, supported by the strong clinical data from the Shasta 3 and Shasta 4 studies. The priority review voucher we acquired 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 Plisacirin, 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. One, the first clinical readout of Aerodymopoe, 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 Aeromap-T being developed as a potential treatment for tauopathy, 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. And three, additional ARRO-INHBE and ARRO-ALT7 data releases are planned in the fourth quarter for this novel non-incorporation strategy, which has quite encouraging early data in obesity and NASH. With that, thank you for joining us today, and I would now like to open the call to your questions. Operator?

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. To withdraw your question, please press star 11 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 Jeffries. Your line is now open.

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? 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, ALP elevations, or glycemic parameters you want to comment on?

Yeah, sure. Mari, 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. 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. So for the time being, for our team, it's really all about generating SNDA modules and study reports and whatnot. finalizing the data that we need for the funding by the end of the year.

Okay. Thanks for taking my questions.

Thank you. One moment for our next question.

Our next question comes from Mike Oltz from Morgan Stanley. Your line is now open.

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 thanks it sure I can take that one also so this will only be healthy volunteer data will be discussing primarily safety and then total town knockdown there's not a lot of other biomarkers that we can measure in the healthies so it's Just a safety and pharmacodynamic dose range-finding study in the healthies. And then, sorry, what was the other part of the question? What knocked in low? So I think that we're still aiming for probably that 50% to 60% knockdown. I mean, that level of knockdown seemed to achieve some level of clinical improvement in the CELIA study. So, I think we've said that all along and we're kind of sticking with that benchmark of 50 to 60 percent knockdown.

Thanks, and congrats again.

Thank you. One moment for our next question. Our next question comes from Brian Cheng from JPMorgan. Your line is now open.

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?

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 five thousand HCP targets to a world will be addressing over twenty thousand HCP targets across both the specialists that I've mentioned previously and also potentially those primary care physicians who act like specialists so we would anticipate the final onboarding of the optimization of our field force to happen before the end of the year as we prepare for a potential So accelerated launch in SHTG in the second quarter of next year.

For our next question.

Our next question comes from Luca Izzy from RBC. Your line is now open.

Oh, great. Yeah, thanks so much for taking my question. Congrats on the progress. Maybe a quick one for James again. Again, you're not commenting on whether there is or there's not a trend in terms of, like, increasing over fast. Again, rightly so, given that, you know, the data's still in Barco at ESP. 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? Just trying to understand what's the sample size here and how meaningful that analysis will be. So that would 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? Will you still continue that trial? Or maybe will you wind that down? Any thoughts there? Much appreciated. Thanks so much.

Yeah, sure. Thanks, Luca. Okay, 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, 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 is going to look like before we make any decisions to stop the study. So for the time being, it's kind of status quo. We're continuing to roll that study and continuing to run the study without any changes.

Thank you, guys.

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

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. 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, you know, very strong TG lowering. 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 Redumplo for most of 2027 or is it just the second half of 2027 I'll take the first question around responder analysis I mean but again you have to wait until ESC to see the actual data on the responder analysis but you know I mean that for SHTG 500 weeks per deciliter is that 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

with the drug right now yeah I think I think both you know both 150 and 500 are important you know it's 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 that's a very attractive tool for physicians and on sorry what was the question on the on the priority voucher 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 yeah so Dina as in we normally would we'll be pursuing both payer policies and coverage for shtg is rapidly as possible. So 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.

Thank you very much.

Thank you. One moment for our next question. Our next question comes from Joseph Tom from TD Cohen. Your line is now open.

Hi there. Congrats on the progress and thank you for taking my question. For the FHCTU market, how would you see the difference in prescribing between the U.S. and European markets or any changes in practice guidelines between the two that we should be thinking about? And maybe of that $3 billion to $4 billion range that you indicated for Plisastran, how much of that is U.S. based versus international markets?

Thank you.

Yeah, I'll take the easy question, the second question. And the majority of that is the United States. They overwhelm the majority of that. Andy, once again, and this is Andy. As far as European market dynamics versus U.S. 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 SHASTA-3 and SHASTA-4 is incredibly important to demonstrating value in the European markets, 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. We'll be the 65th company to tell you that given the uncertainty around MFN, And it's very difficult for us to, at this point, you know, 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 XUS markets.

Perfect. Thank you.

Thank you. One moment for our next question. The question comes from Jane Kuldis from Stifle. Your line is now open.

Hey, thanks for taking my question. and congrats on all the progress.

Maybe one on Triggs and just specifically as it relates to sort of your expectations around the commercial opportunity. You know, 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, like, how important you think the initial quarters, you know, for this class are um to sort of validating or reading on to the size of the overall opportunity here thanks so much 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 so we'll be hyper focused on ensuring that our our providers are well educated on the value of redemplo in shtg and we'll also simultaneously of course be working with payers to to get policies published in and coverage in place in order to to accelerate the ramp of over DEMPLO and SXTG as you would know there is a high degree of overlap between those prescribers who are writing for familial chylomicronemia syndrome and those who will also write for SXTG 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 the ramp that we're seeing in FCS bodes well for the ramp we would expect to see in SHTG also and you know I'll give you a you know a qualitative answer also but we think that SHTG is a very large market opportunity there's an there's an awful lot of patients who have triglycerides that we really need to help get under control we're convinced of that our KOLs are convinced of that however this is going to be a relatively slow range because this is a brand new market 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 has been in part at least because there have been you know no good ways to really reduce traviserides until now and so so this is all a good thing for patients it's just going to take a bit of time to educate those patients and educate physicians.

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

Hi, guys. Congrats on the progress, and thanks for taking our question here. Maybe how should we think about the doubling of Rendimplo prescriptions, I guess, in terms of weekly run rate? i think 30 per week maybe was the last disclosure you guys put out um and then relatedly has the prescription to drug and arm conversion rate kind of hit the steady state for fcs um and if not kind of just one of the drivers there and then secondly if i can quickly uh for ESC, I know you're under embargo, so just a general question. Do you expect the learnings there are more academic in nature, or is it something that really kind of facilitates a naive cross-trial comparison and really kind of informs the label? Thanks.

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 have 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. 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. 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 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 those patients shipping 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 that was good i think so thank you one moment for our next question our next question comes from patrick totucci from hc wainwright your line is now open hi everyone thank you for taking our questions this is for patrick um we're thinking about the launch in the shtg will it be in the highest risk patients will be segmented to the highest risk patients or more

broadly across patients with TGs above 500 and the question is directed at how would this reflect on the commercial builds will it be a step function or be an incremental expansion of yes of the existing FCS field force 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 will 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 by payers 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 that will go into the field this month and we'll continue to look to optimize our field force as we head towards SHDG. 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, you know, full stop. 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. 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, you know, to help physicians and patients understand the risk here.

Great. Thank you, and congratulations. Thank you.

Thank you. One moment for our next question. Our next question comes from Kay from Chardon Capital Market. Your line is now open.

Hi. Thank you. Now that you have your data, how are you thinking about price differential versus tringosa?

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 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 of quarterly dosing rather than a monthly dosing, you know, a lack of need to, we believe a lack of need to follow the enzymes because we haven't seen those issues, and, you know, a simple, you know, 25 milligram dose for all patients rather than having it titrate up.

Okay, thanks.

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

Hi, this is Jennifer G.S. for our AdLaw. Congrats on the Shafsa results. So for the neuro programs, what other CMS targets are you excited about if the phase 1 and 2 for MAP-T is positive?

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

Yes, yes, for knockdown, if the MAP-T works out.

Sure. So, 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 CTA filing, just given the competitive nature in the SIRNA space right now. So, stay tuned.

Great.

Thank you.

Thank you. one moment for our next question.

Edward Tendorf from Piper Sandler is our next question. Your line is now open.

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 U.S., Canada, Austria, 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 SC&H? I want to understand those dynamics more. Thank you.

Thanks for the question, Edward. Good question. This is Andy again. And so we are marketing into those countries that you mentioned using commercial partners. So Redempolo 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.

And in terms of revenue recognition?

So in terms of revenue recognition, I just follow the standard. so there's data here, all the standard revenue recognition, so as we as we complete a sale to customers in those countries we would recognize revenue. So nothing nothing unique or in that regard.

Is it a net revenue or is there a fee that's paid in STA? Thanks so much.

Oh yeah, no it's a I mean it's it's similar to the u.s. so it would be a gross sale and then we have in in the gross to that you have to deduct out sort of distribution costs and like but if you're asking about the cost to support that is being offered by our commercial partners there just kind of like a contract marketing contract sales that would show up in marketing sales costs so that would not be great but Super helpful, Dan.

Thanks, guys. Keep up. Thanks, Ed.

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

Thanks very much for joining us today. We look forward to speaking with you later in August after ESC and then in September around the era of our PA disclosures, as well as in MAP-T.

Have a great summer.

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