Arrowhead Pharmaceuticals, Inc Q1 2026 Earnings Call Transcript

Arrowhead Pharmaceuticals, Inc (NASDAQ: ARWR) Q1 2026 Earnings Call dated Feb. 05, 2026

Presentation

Operator

Ladies and gentlemen, welcome to the Arrowhead Pharmaceuticals Conference Call. Throughout today’s recorded presentation, all participants will be in a listen only mode. After the presentation, there will be an opportunity to ask questions. I will now hand the conference over to Vince Anzalone, Vice President of Investor Relations for Arrowhead. Please go ahead. Vince.

Vincent Anzalone — Head of Investor Relations & Vice President

Thank you. Victor Good afternoon and thank you for. Joining us today to discuss Arrowhead’s results for its fiscal 2026 first quarter ended December 31, 2025. With us today from management, our President and CEO, Dr. Chris Anzalone 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 and D, who will discuss our development programs and Dan Appel, Chief Financial Officer, who will give. Over 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 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 10K and our quarterly reports on Form 10Q.

And now I’d like to turn the call over to Chris Hansloni, President and CEO of the Company. Chris

Dr. Christopher Anzalone — Chairman, Chief Executive Officer & President

Thanks, Vince. Good afternoon everyone and thank you for joining us today. We had another quarter of strong execution across all areas of our business and we are well positioned to build on this progress throughout 2026 and beyond. In fact, the recent months have included some of the more significant achievements in Arrowhead’s history. Talk about some of these. First, on November 18, 2025, Arrowhead received its first regulatory approval and began the next phase of growth as a commercial company marketing its own medicines.

The FDA approved rademflo as an adjunct to diet to reduce triglycerides in adults with Familial columnicronemia syndrome, or FCS. FCS is a severe rare disease with an estimated 6,500 people in the US living with genetic or clinical FCS characterized by TG levels that can be 10 to 100 times higher than normal, leading to a substantially higher risk of developing acute, recurrent and potentially fatal pancreatitis. This approval was supported by clinical data from the phase 3 palisade study in adults with either clinically diagnosed or genetically confirmed FCs. The Palisade study demonstrated deep and durable reductions in TGs with a median reduction of 80% from baseline and a lower numerical incidence of acute pancreatitis events compared to placebo.

Arrowhead launched Redempolo independently in the US with a one redemptlo pricing model that creates one consistent price across current and potential future indications. This is important. We’re committed to sustainable innovation and this requires a rational drug pricing according to the value a medicine offers to patients and healthcare systems. Redempo is a pancreatitis drug and when we think about pricing we look to those patient populations at greatest risk of acute Tg related pancreatitis. We’ve only had drug in channel for about 10 weeks, which included Thanksgiving, Christmas and New Year’s holidays, so it is difficult to infer too much about launch.

However, initial trends in prescriptions, payer interactions and shipments have been encouraging. To date, over 100 prescriptions for Adempolo have been received from a diverse prescriber base with geographically balanced uptake across the US early patient starts fall into three categories patients transitioning from our expanded access program, patients naive to the Apoc 3 class, and patients switching from Olazarcity. In addition, Redempolo shipments are being made for patients with clinically diagnosed and genetically confirmed STS. In addition to FDA approval. We announced in January 2026 that RedempFlo also received approval. The treatment of FCS from Health Canada and from the Chinese National Medical Products Administration.

Redempolo will be available later this year in Canada and we anticipate it will be marketed independently by Arrowhead pending regulatory review and approval. We expect to potentially launch Redempolo later this year in select EU countries and in the uk. In Greater China, Radempolo will be marketed by Sanofi. Our cardiometabolic pipeline is off to a good start with Redempol and the ongoing phase 3 study of zodaserin in homozygous familial hypercholesterolemia or HOFH. We are actively expanding this pipeline with a number of discovery programs and importantly three clinical programs. AroinHPE and Aroalk 7 being developed as potential treatments for obesity are in phase 12 studies.

We also recently initiated a phase 12 study of Arodimer PA in patients with mixed hyperlipidemia for our initial obesity candidates we recently announced some early Interim Clinical Data ARO INHPE enhanced weight loss and fat reduction versus tirzepatide alone in obese patients with type 2 diabetes. More specifically, two administrations of AROINHP at the 400 milligram dose in combination with tirzepatide achieved approximately two fold better weight loss at week 16 than tirzepatide alone. This appears to be high quality weight loss as we saw an approximately three fold reduction in each of total fat, visceral fat and liver fat measures based on week 12 MRI versus tirzepatide alone in these patients.

The Arol 7 Phase1.2 study is approximately 2/4 behind the Arrow INHP study, but early data are encouraging. We believe this is the first RNAi therapeutic to show adiposetin gene target silencing in a clinical trial and we’ve seen dose dependent reductions in adipose alk7mrna with a mean reduction of minus 88% at the 200 milligram dose at week 8 and a maximum reduction of minus 94%. While these are very intriguing data, they are early and incomplete, so we have substantial work ahead of us before we get too excited about how these candidates could eventually be used. We will continue to run both phase 12 studies, we are expanding existing cohorts to increase power and we are adding new cohorts to better understand these candidates and underlying biology.

We intend to report additional results later in 2026. Aerodymer PA is being developed as a potential treatment for atherosclerotic cardiovascular disease or ascvd, due to mixed hyperlipidemia where both LDL cholesterol and triglycerides are elevated. We believe There are approximately 20 million people in the US with mixed hyperlipidemia and this is a patient population without adequate treatment options. We recently announced that we dosed the first patients in the Phase 12 clinical trial of Aerodimer PA, which is a dual functional RNAi therapeutic designed silence expression of the PCSK9 and APO C3 genes, thus designed to reduce both LDL cholesterol and TGS.

This represents an important step forward for the RNAi field as we believe it is the first clinical candidate to target two genes simultaneously in one molecule and an important step forward for preventative cardiology as both LDL and TGS have epidemiologic support as being important drivers for ASCVD risk. We expect to have interim data for arrow rpa in the second half of 2026 if we see good LDL and TG reduction in a well tolerated manner, we may have something truly special for a very large and currently underserved patient population outside of cardiometabolic. We made important advances in our CNS portfolio, specifically in programs that utilize a new proprietary delivery system designed to achieve blood brain barrier or BBV penetration.

Utilizing subcutaneous administration in non clinical studies across multiple animal models, we saw deep target gene knockdown across the CNS including deep brain regions. This underscores Aeroved’s leadership in the delivery of SIRNA to multiple tissues and cell types throughout the body utilizing the proprietary TRIM platform. Our first wholly owned program using the BBB platform is Arrow mapt, being developed as a potential treatment for tauopathies including Alzheimer’s disease. During the last quarter we announced that we dosed the first subjects in a phase 12 clinical trial that will include healthy volunteers and Alzheimer’s patients. Aromapt targets the tau protein in the brain, which has good biological validation as a potential driver of pathology and has emerged as a promising target for Alzheimer’s disease and additional taupathies.

We anticipate interim clinical data from the healthy volunteer portion of the study should be available in 2026 with data from the Alzheimer’s patients to follow in 2027. This is a very exciting program for us. The second program to use our BVB delivery system is SRP 1005, formerly called Arrow HTT for the treatment of Hunting’s disease. This program is partnered with Sarepta which recently announced the submission of its CTA for study SRP 1005 101, also known as INSIGHT, in approximately 24 participants. While our cardiometabolic and CNS work by no means encompasses everything we are doing, they are areas of substantial focus and potential value drivers in the near mid and long term.

Within these areas, we are addressing three of the greatest public health challenges of our time obesity, cardiovascular disease and neurodegenerative conditions. Now I’d like to move on to some key events during the recent period that have dramatically strengthened our balance sheet and give us the necessary resources to push multiple programs toward commercialization. We anticipate being funded through multiple potential independent and partner launches. These meaningfully these meaningfully increase revenue opportunities for the company and push us to toward becoming cash flow positive and self sustaining from commercial sales. Since our last reporting period we have completed transactions with gross proceeds of $1.33 billion.

Let’s break that down first. We completed a global licensing and collaboration agreement with Novartis for Arrow snca. Arrowhead’s preclinical stage SIRNA therapy against alpha Synuclein for the treatment of synucleinopathies such as Parkinson’s disease. The collaboration includes a limited number of additional targets outside our pipeline that will utilize Arrowhead’s proprietary TRIM platform. Arrowhead received a $200 million upfront payment and is also eligible to receive development, regulatory and sales milestone payments of up to $2 billion. Airhead is further eligible to receive tiered royalties on commercial sales up to low double digits. Second, we earned $200 million milestone payment from Sarepta following a Drug Safety Committee review and subsequent authorization to dose escalate and achievement of the second pre specified patient enrollment target for Arrow DM1.

Third, we closed concurrent public offerings of $700 million, aggregate principal amount of 0% coupon, convertible senior notes and $230 million of common stock. Both offerings were several times oversubscribed and priced at company friendly terms. As I mentioned at the beginning of the call, we demonstrated strong execution across all areas of our business. We received regulatory approval in three different countries, we launched our first commercial product, we continued to grow our cardiometabolic portfolio, we had encouraging early results from our obesity programs, we advanced our TRIM platform and CNS pipeline, and we meaningfully improved our financial position to push these and other programs forward.

It has been a productive last few months at Arrowhead with so much potential to continue the strong progress in 2026 and beyond. With that overview, I’d now like to turn the call over to Andy Davis. Andy

Andy Davis — SVP of Cardiovascular & Head of Metabolic Franchise

thank you Chris and good afternoon everyone. It has been just over two months since the approval of Redempolo on November 18, 2025 and we are very pleased with the progress we are seeing. I’d like to share some early insights across healthcare provider engagement, patient dynamics, and payer developments. I’ll start with Healthcare provider Engagement. As a reminder, we are targeting approximately 5,000 healthcare professionals through personal promotion, complemented by a much broader Omni Channel effort. Early prescribing has been led by preventive cardiologists and endocrinologists who together account for approximately 70% of total prescriptions, with the remainder coming from internal medicine physicians focused on lipid disorders.

In addition, advanced practice providers, including nurse practitioners and physician associates working within multidisciplinary care teams are playing a meaningful role in patient identification and treatment decisions. Turning to Patient Dynamics As Chris mentioned, over 100 prescriptions for Adenflo have been received to date. We see this as a very strong start that exceeded our expectations for the early months of the launch. We are also seeing geographically balanced uptake across the United States. Early patient starts fall into three categories, patients transitioning from our expanded access program, patients naive to the Apoc 3 class, and patients switching from Olazarcin class.

Naive patients represent the overwhelming majority of starts that expanded access and switched patients contributing evenly to the remainder. Patients receiving rodent FLO include both clinically diagnosed and genetically confirmed FDs, with the majority not required to submit genetic testing to gain access. Importantly, a high proportion of patients are enrolling in the Relion Redemflo Patient Support Program and in the fiscal first quarter, patients eligible for copay assistance pay $0 out of pocket. Next I’ll touch on payer developments. While it is still early, we remain encouraged by positive payer feedback on both the clinical profile of Redemflo and our unified one Redemflo pricing approach.

We are actively engaged with the largest payers and discussions to date reflect a willingness to cover redemplo to label, including access based on either genetic or clinical diagnosis of fcs. I’d like to conclude with a brief comment on execution. Within days of FDA approval, we had product available in the channel for FDS patients. Our redempo care coordinators, rare disease specialists, and field reimbursement navigators were deployed on day one to support prescribers and patients, and our payer account team continues to work closely with customers to minimize access barriers. The teams are off to a great. Start and our teams are highly encouraged by early stakeholder feedback. This feedback further reinforces the key differentiating attributes of rademplo. As a reminder, in the Palisade study, Rademplo reduced triglycerides by 80% from baseline as early as month one and maintained this reduction with minimal variability through 12 months of treatment. In addition, the numerical incidence of acute pancreatitis was lower in redempolar treated patients than in placebo and the US Approved prescribing information includes no contraindications, no warnings and no precautions and Redemflo can be self administered at home once every three months, just four injections per year.

With that, I’ll turn the call over to James Hamilton to discuss the RD portfolio.

James Hamilton — Chief Medical Officer and Head of R&D

Thank you Andy. I’d like to start with a reviewOf the redentflo FDA approval and information in the label and condition contained in the package insert. Redempolo is approved as an adjunct to diet to reduce triglycerides in adults with FCS. The recommended dose of Rudempolo is 25mg and it can be self administered at home by subcutaneous injection once every three months. Redempol has no contraindications, warnings or precautions. In the U.S. fDA approved label, the most common adverse reaction includes hyperglycemia, headache, nausea and injection site reactions. Prudempolo was studied in patients with both genetic STS and clinically diagnosed STS. In the Phase 3 Palisade study, patients achieved deep and durable reductions in median triglycerides of around 80% from baseline, with reductions largely maintained below the guideline directed threshold of 500mg per deciliter throughout the year of treatment.

Importantly, patients with genetic FCS versus clinical FCS showed similar reductions from baseline. We see the clinical FCS population as having the same high unmet need as the genetic FCS group and as such we think it’s crucial to have shown that both patient populations showed similar large reduction from baseline in triglycerides. In Palisade treated patients also had a reduced rate of adjudicated acute pancreatitis events, a very welcome finding for FCS patients and their caregivers and an important validation that reduction in triglycerides can in fact lead to reductions in pancreatitis. In addition to fcs, we are also investigating clizaceran in patients with severe hypertriglyceridemia or shtg.

We announced last quarter that the FDA granted Breakthrough Therapy designation to investigational plazaseran as an adjunct to diet to reduce triglycerides in adults with shtg. Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on clinically significant end forms. This is another important step for the program. The global phase 3 studies of plesaceran designed to support the supplemental NDA filing to expand the label beyond genetic and clinical SES of the Shasta 3 and Shasta 4 studies, which enrolled approximately 750 patients, and miR3, which enrolled 1400 patients.

We’re also enrolling patients in Shasta 5 to directly assess the ability of plazaceran to reduce the risk of acute pancreatitis as the primary endpoint. We remain on schedule to complete the blinded portion of the Shasta 3, Shasta 4 and Mir 3 Phase 3 clinical studies in mid-2026. We expect top line data to be available in the third quarter of 2026 with planned SMDA submission for SH before the end of the year. We presented the study design and baseline Characteristics of the Shasta 3 and Shasta 4 studies at the 23rd World Congress Insulin Resistance, Diabetes and Cardiovascular Disease in December 2025.

I’d like to spend a moment to go over a few key parts of that poster. The primary endpoint of the Shasta studies and the accepted regulatory endpoint is TG lowering versus placebo. Flizaceran has been highly active in all patient populations studied, so these studies are overpowered to show TG lowering. One of the additional objectives and key secondary endpoints of Shasta 3 and Shasta 4 studies includes the assessment of acute pancreatitis rates. To be clear, the study was not designed or prospectively powered to demonstrate AP rate reduction after just a year of treatment. However, there are a meaningful number of SATG patients enrolled that would be considered at high risk for AP.

Specifically, among the two studies which will be pooled for AP event assessment, 37% of enrolled patients reported TGS greater than 880 milligrams per deciliter accepted high risk threshold for AP. In addition, 20% of enrolled patients had a prior medical history of pancreatitis. Lastly, we are seeing AP events in the studies. We are of course still blinded and have about another four months before the last patient reaches the end of the blinded period, but overall the studies are progressing as planned. Chris mentioned the interim obesity results from our ARO inhibit E and Aroalk 7 programs earlier, but I’d like to add some color and talk about what we’re adding to these programs first.

These early results were very encouraging. The next steps would be to investigate whether and where there is a therapeutic benefit and in the patient segments and treatment settings where it may be applicable to review. The interim clinical trial results represent the first demonstration in humans that the activin E alk7 pathway, a genetically validated pathway that regulates adipose fast storage, may potentially be harnessed therapeutically to improve body composition and enhance weight loss versus tirzepatide treatment alone. In obese patients with type 2 diabetes mellitus. This patient population typically experiences less weight loss with ingredient therapy. They’re less likely to reach weight loss. Targets and need more effective treatment options. Importantly, Arowin hibone in combination with tirzepatide achieved approximately two fold weight loss and approximately three fold reduction in visceral fat, total fat and liver fat versus tirzepatide alone. In obese diabetics. We saw signals that the pathway was active in the non diabetics as well, but based on early data the diabetic signal, particularly in combination with tirzepatide, appeared to be the clearest. We are already in the planning and execution stage of the following next steps increasing numbers of patients in the phase 1 diabetic cohorts, including longer follow up and better to better understand drug durability and activity out to one year and initiating monotherapy cohorts in obese diabetic patients.

We expect to have more data later in 2026 from these programs as we see data from the new expanded scope of the Phase 12 studies. I will now turn the call over to Dan Appel.

Daniel Apel — Chief Financial Officer

Thank you James and good afternoon everyone. I’ll provide a brief outline of our financial picture as we reported today, net income for the quarter end of December 31, 2025 was 30.8 million for an income of $0.22 per share based on 140.7 million fully diluted weighted average shares outstanding. This compares to a Net loss of 173.1 million or loss of $1.39 per share for the quarter ended December 31, 2024 based on 124.8 million fully diluted weighted average shares outstanding at that time. Revenue for the quarter totaled 264 million, driven primarily by our license and collaborations agreements with Saripta and Novartis.

Of this amount, approximately 229 million related to the Sarepta collaboration and this included 181 million from the achievement of the second deem1 milestone, 32 million from the ongoing recognition of the initial Surrepta consideration, and 17 million related to reimbursement of incurred collaboration program costs. In addition, we recognized 34 million of the 200 million upfront payment we received from Novartis under our global licensing and collaboration agreement with them. The remainder of that $200 million will be deferred over time as we fulfill our pre clinical collaboration obligations. Finally, on revenue, we also recorded our first commercial sale of Clodasserin in scs.

As both Chris and Andy have mentioned, we are very encouraged with the feedback and uptake we are seeing with patients and providers. For now, we are not disclosing specific sales numbers until such time as they become a meaningful driver to our financials. Turning to expenses, total operating expenses for the quarter were approximately $223 million compared to $164 million in the prior year quarter, representing an increase of $59 million year over year. This increase was driven by $40 million of higher RD expenses and $19 million of higher SGD expenses. To break that down, the increase in R and D expense was primarily attributable to, as planned, higher clinical costs associated with our phase three registration of studies for Clazacerin in SHTG as well as increased clinical supply chain costs.

Nearly half of our clinical trial spend in the quarter was associated with our three registration SHTG studies, namely Shasta 3, Shasta 4 and Year, which again should read out in the summer. SGA expenses increased year over year compared to the prior year’s fiscal first quarter, primarily driven by investments to support the commercialization of Redempo. As previously discussed in advance of the US launch, we built robust commercial capabilities to fully support FCS and importantly capabilities that were intentionally designed to be highly leverageable downstream should we obtain approval for Clazacerin in SHTG and sodasserin in hofh. Turning now to the balance sheet cash and investments totaled $917 million as of December 31, 2025.

Common shares outstanding at quarter end were $137.4 million. To be clear, the reported cash balance does not include the $200 million that we earned for the DiEM one second milestone which was received in January. Nor does it include the 50 million anniversary payment that we expect to receive from Sarepta on or before February 10th. Finally, and importantly, the cash balance of $970 million also does not include the financing transactions announced in early January consisting of a concurrent offering of convertible senior notes in common stock along with associated capped call transactions. As Chris mentioned, these were on company friendly terms in the sense that the convertible was 0% coupon and the initial conversion premium was 35%.

Said another way, the 0% coupon means the notes will not bear regular interest and the principal amount of the notes will not accrete. The initial conversion price represents a significant premium of approximately 35% over the public offering price per share of common stock in the common stock offering. Moreover, the private cap calls will prevent any dilution to existing shareholders up to an 85% of the premium over the offering price, or roughly $119. We estimate that the total cost of capital of that convertible at any share price below that $119 to be very attractively below 1.5%.

All that is to say that we have very significantly and efficiently strengthened our balance sheet which provides additional flexibility to support ongoing clinical development, current and future commercialization activities and other long term strategic priorities. With that brief overview, I will now turn the call back to Chris.

Dr. Christopher Anzalone — Chairman, Chief Executive Officer & President

Thanks Dan. This is indeed an exciting time to be an arrowhead or an arrowhead shareholder. We’re coming off an historic period for the company where we executed extremely well and all the hard work of the last several years is starting to pay off. While 2025 was productive, we look to the remainder of 2026 and the years ahead to be even more transformational. Let’s look at some key 2026 events that we anticipate could be important value creating events for the company and our shareholders. Commercial Sales Progress for Radempo Q3 2026 readout of Phase 3, Shasta 3 and Shasta 4 studies of plazacerin in patients with SHTG, which we believe has the potential to be a 3 to 4 billion dollars commercial opportunity.

Second half 2026 readout for Aerodimer PA targeting PCSK9 and Apost3 for LDL and TG lowering, which may address mixed hyperlipidemia, a population of potentially 20 million patients in the U.S. additional Arrow INHP and AROAP 7 data presented in 2026 that may build on the already encouraging early data for this novel non incretin strategy and early aromap t data in 2026 potentially providing validation for this drug candidate and our emerging CNS pipeline with systemic delivery via subcutaneous administration. These are just a few potentially important events in 2026 alone. If you fast forward one to three years, we expect many more opportunities in our pipeline to build value and potential commercial launches both independently and with partners.

Thank you for joining us today and I would now like to open the call to your questions Operator.

Question & Answers

Operator

Thank you. To ask a question you need to press star 11 and wait for a name to be announced. To withdraw your question, please press star 11. Again, please. One question in the interest of time. Any additional questions, you can go back into the queue. Please stand by the Q and A roster a moment for our first question. Our first question will come from the line of Mike Ose from Morgan Stanley. Your line is open.

Michael Ulz

Good afternoon and thanks for taking the question. Maybe just one on Redempo. Can you just give a little bit more color on the breakdown between the different categories of patients transitioning from expanded access naive and switch and then maybe on the latter in terms of switch. Just any key reasons you’re seeing a switch and does it have anything to do with coverage and pricing? Thanks.

Andy Davis — SVP of Cardiovascular & Head of Metabolic Franchise

Thanks Mike. This is Andy. Yeah, I can comment that the vast majority patient origination is from Apoc3 naive segment, with the remaining balance split roughly 5050 between those that are coming from Switch and those that are transitioning off of the Expanded access program. As it relates to Switch, we’re seeing switch patients that are coming both from efficacy but also from safety as the Two principal drivers for why physicians might be considering RIDMPLO as an alternative. I hope that helps.

Operator

Thank you. One moment for our next question. Our next question comes online to Maury Raycroft from Jefferies. Your line is open.

Maurice Raycroft

Hi. Congrats on the progress and thanks for taking my question. I’ll ask one on obesity. Just wondering if you’ve had discussions with FDA about the development path or when would it make sense to do this and what could timelines for your phase two star look like? And do you need to have all the data, including combo data, in hand before you can determine next steps for the development path?

James Hamilton — Chief Medical Officer and Head of R&D

Yeah, sure, Mario, I can take that. This is James. Probably middle of the year, we would be having some of those discussions with fda. I don’t think we need all of the data from all of the cohorts. As I mentioned in the prepared remarks, we expanded some of these cohorts so they’ll be going on some of them for a longer period of time. So, you know, FDA conversations probably middle around middle of the year. And then we’ll be looking to file an IND shortly thereafter.

Operator

Thank you. One moment for our next question. Our next question will come from the line of Andrea Newkirk from Goldman Sachs. Your line is open.

Andrea Newkirk — Analyst, Goldman Sachs

Hi guys. Good afternoon. Thanks for taking the question. Maybe I can ask you one here on the Arrow Dimer PA asset. Just as we think about the data set that’s coming later this year, just curious if you might be willing to speculate or share what you are looking for or how you’ve defined a tpp, what level of reduction in LDLC and trigs you’re hoping to see and then how that might inform a go, no go decision for advancing the asset forward and what extent of reduction would give you confidence that you could then see that translation to a benefit on Mace.

Thanks so much.

James Hamilton — Chief Medical Officer and Head of R&D

Yeah, sure. We’ll see. I think we probably don’t have to reach the level of reduction in terms of Apoc3 and triglycerides that we’re seeing with Clozaceran, for example, something less than that with the combination of the LDL cholesterol reductions would probably be sufficient. So, you know, I think if you look at some of the monkey data that we presented in the dyslipidemic monkeys, we were seeing reductions in LDL and in triglycerides of around 40, 50%. So I think something like that, if you could do both of those, that would, that’d be really encouraging. But we’ll see what the data show later this year.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Luca Issey from RBC Capital Markets. Your line is open.

Unidentified Participant

Thanks so much. Hi team. This is Cassie on for LUCA Congress on strong redampo launch and progresses. A question also on Ahebi and alx. Since we just talked about the regulatory path. Andy, appreciate early days but how are you thinking about potential pricing for inhibit and aux 7? I mean Lilly now offers that Bound Valley direct at 300amonth and the compounders announced today that you can get oral reag basically at the same monthly price as YouTube TV. So what is your latest thinking on pricing and how should we think about COGS for Enhibi and aux 7? Thanks so much.

Dr. Christopher Anzalone — Chairman, Chief Executive Officer & President

Thanks. It is as you expected. It’s way too early for us to think about that. You know, we’re interrogating the biology here to see how these drug candidates could potentially work in various patient populations. Until we have a better understanding of that, you know, it’s really too early. To speculate on potential pricing.

Operator

Thank you. One moment for our next question. Our next question comes Prakar Agrawal from Cancer. Your line is open.

Prakhar Agrawal

Hi, thank you for taking my questions and congrats on the quarter and the progress. So I think James, you mentioned that about the pancreatitis event rates in the ongoing phase 3 Shasta 34 trials. Maybe if you can talk about the blinded AP events that you’re seeing in those trials and whether it’s in the same ballpark of what Ionis saw. And just a follow up to that, would you expect the placebo event rate on AP reduction to perform similarly to Olisarcine core trials given the population looks similar or are there any nuances that we should be aware of? Thank you so much.

James Hamilton — Chief Medical Officer and Head of R&D

Yes. So on the first one, we’re not going to give any additional details on event rates or the number of events that we’ve seen other than to say that we are seeing events. On the second question, I mean I think it’s rational to look at the in the core and the core two placebo rate that the population was similar to ours. So they are obviously different studies, but the population was similar.

Operator

You. One moment. Our next question. Next question comes line of Jason Gerberry from Bank of America. Your line is open.

Jason Gerberry

Hey guys, thanks for taking my question. You mentioned payer feedback for Redempo. I believe that was in the context of fcs. But I’m curious if in those discussions shtg came up at all and whether that price point that you guys have for FCS is appropriate for a market the size of shtg and the likely benefits that APOC3 would provide. It seems pretty de risked at this point, but just kind of curious if those discussions came up and how the view was on the 60k price point. Thanks.

Andy Davis — SVP of Cardiovascular & Head of Metabolic Franchise

Thanks Jason. This is Andy. Appreciate the question. I won’t get into the details of any specific payer discussions, only to say that our team is laser focused on ensuring we can gain coverage and access for those patients that have FCs either genetically confirmed or clinically diagnosed. I would just add that the payers with whom we’re discussing represent over 90% of US lives and both the clinical teams and the economic teams recognize the clinical value and the economic value of Radempolo at the one redempt low price that we previously announced.

Jason Gerberry

Thanks.

Dr. Christopher Anzalone — Chairman, Chief Executive Officer & President

And you mentioned the size of the SHTG market. We think there are somewhere around three and a half million people with triglycerides above 500. But that market is not all created equal. When we look at our at least initial target market there and we look at how we price for Demblock, it is really focused on those very high risk individuals, those maybe 750,000 to maybe a million people who have triglycerides above 880 or history of pancreatitis, at least initially. That is the real core market. Those are the patients who really need this new medicine. So again, don’t get lost in the 3 to 4 million people with trigs above 500.

Really focus on that high risk. That’s who we’re focusing on, at least initially.

Operator

Thank you. One moment for our next question. Our next question will come from the line of Patrick Truccio from H.C. wainwright. Your line is open.

Patrick Trucchio — Analyst, H.C. Wainwright

Thanks. My question is on Arrow Mapt. I’m just curious with the interim data from the healthy volunteer portion and then with the patient data to follow, I’m wondering what specific elements of the healthy volunteer data safety, CSF tau knockdown or downstream biomarkers would most likely increase your confidence in this program and as well the data we should look for in patients to follow. And if you could also just talk about, you know, just the confidence this would give in the CNS targeting and platform overall and how we should expect, you know, the CNS platform to develop from here.

James Hamilton — Chief Medical Officer and Head of R&D

Yeah, I can take that. Patrick, this is James. So maybe I’ll take the second question first. You know, we don’t have any data in the clinic yet any data from humans, but we do have data using the platform with multiple different targets in multiple different monkey studies. And they’re pretty consistent in terms of the drug concentration that we get in various CNS regions and the knockdown we’re able to achieve in the deep brain. So that is helpful and certainly enhances our confidence. But of course, the large leap in confidence will come once we see the clinical data.

And to your first question, I think the key data that we anticipate being confidence building. Of course, safety and then the CSS knockdown will be key in the healthy volunteers. There’s not a lot of other downstream biomarkers to measure in the healthy volunteers. But then going forward into the patient cohorts, we can measure some of the phospho tau varieties in the blood, also in the csf. And then of course we can look at Taupet. Although those readouts will take a while to see the Taupet signals in the patients, seeing a reduction in Taupet signal will be really very encouraging.

Operator

Thank you. One moment for our next question. Next question will come from the line of Edward Tentoff from Piper Sandler. Your line is open.

Edward Tenthoff — Analyst, Piper Sandler

Great. Thank you very much. So thanks for all the detail. It’s really exciting to see the pipeline advancing. I’m wondering when it comes to the recognition of revenues at this point, are you guys anticipating breaking out a cost of goods sold line? I’m sure a lot of the manufacturing expense has already been a fence to R and D, but I’m just trying to think about how you’re planning on reporting HUDs going forward and will you break out redempo product sales in the future too? Thanks.

Daniel Apel — Chief Financial Officer

Yeah, thanks, Ted. Thanks for the question. Yeah, as you pointed out, the cost of goods, so part of Lonzo are going to be in the R and D and that’s the majority of what we’re going to see in the short term. You know, we said in the prepared remarks we’re not, we’re not going to disclose this, you know, actively until such time as there are meaningful drivers. So we will at some point, not going to hazard a guess as to when that will be. But then you would at that point you would normally see then sort of that traditional product revenue and public cost.

Operator

Thank you. One moment for our next question. Our next question comes Joseph Thome from TD Cavan. Your line is open.

Joseph Thome

Hi there. Good afternoon. Thank you for taking my question. Maybe just based on the differential biology of activating in Elk 7, can you talk a little bit about your expectation to see monotherapy weight loss in obese non diabetic patients with the Elk 7 and a point of clarification when you talk about the expansions of the studies in terms of including that monotherapy diabetic population and expand the overall size, was that for the Activin E and Elk 7 programs? Already? Both of them. Thank you.

James Hamilton — Chief Medical Officer and Head of R&D

Yeah, I think we don’t really have expectations in terms of monotherapy weight loss. We’ll see what happens. I think said a few times that we view these studies as hypothesis generating. So we like to see if there’s an early signal and then potentially expand cohorts to confirm that signal. So can’t really predict ahead of time what we’re going to see. Then on your second question, the addition of the monotherapy cohort, we did add that in the inhibited study. We will likely add that in the Elk 7 study as well.

Operator

Thank you. One moment for our next question. Our next question comes online of Mani Furuhar from Learing Partners. Your line is open.

Mani Foroohar

Hey guys, thanks for taking the question. I had a little bit technical snapshot. There earlier, so not sure if this was asked earlier, but could you give us a breakdown of the EAP versus non EAP patients out of the 100 plus prescriptions? And how should we think about the total pool of EAP patients rolling on to commercial drug? Is there a tail of that remaining? And I have a follow up question.

Andy Davis — SVP of Cardiovascular & Head of Metabolic Franchise

Thanks for your question, Monet. This is Andy. At this time we’re not going to provide any further details. Aside from the previous remarks, which the vast majority of patients are Apoc3 naive, that gives us a lot of optimism about our ability to identify and diagnose both genetically confirmed and clinically diagnosed FCS patients. And again, with respect to the balance, we do see that fairly evenly split between those patients transitioning off of the expanded access program and those that are coming via switch.

Mani Foroohar

Okay, that’s helpful. And a separate question. What are the expectations we should have over the next 12 to 18 months around potential data sets, admittedly perhaps early on novel tissue types and further expansion of the platform?

Dr. Christopher Anzalone — Chairman, Chief Executive Officer & President

That’s a good question, Manny. We’ve not given any guidance for that at this point. I think we have enough exciting stuff, you know, with, you know, with more inhibiting Alpha 7 data, with, you know, with initial map T data, with initial timer data, with Shasta 3 and 4 reading out, you know, with redemptive sales, you know, that we feel pretty good about those things. But you know, you know, you know us, Manny. We are always developing the platform and we are always expanding to the sites and so, and so I can’t. It’s possible that you may, you may. Hear. Something about where we’re going with the platform as well as meeting new candidates within the existing platform. I just can’t give you any guidance on when that might be. I apologize.

Operator

Thank you. One moment for our next question. Our next question will come from the line of Madison Elsadi from B. Riley. Your line is open.

Madison Wynne El-Saadi — Analyst, B. Riley

Hi guys. Thanks for taking our question on the 100 prescriptions you mentioned. I’m curious, how many of those do you expect to be converted to paid drug and how long does it take to get from prescription to drug and body? And then relatedly, how should we think about the pace of both patient onboarding and competitive switching? Is this kind of a leading indicator for shtg dynamics? Thanks.

Andy Davis — SVP of Cardiovascular & Head of Metabolic Franchise

Thanks, Madison. Happy to comment. What we’re seeing are really high quality prescriptions in the sense that we believe these prescriptions truly represent either genetically confirmed or clinically diagnosed FCS patients. So we do have high confidence that a significant proportion of those prescriptions will in time translate into drug shipments and drug inpatients. As far as the time it takes from prescription to drug shipment, again, that does vary by patient, by insurance and by prior authorization. But I would say in general we’re able to do that within just a couple of weeks from prescription to patient receiving drugs.

So I’ve been incredibly pleased with the patient identification, including both genetic and clinically diagnosed, and incredibly pleased with the operational execution from the team in converting prescriptions to shift medicine.

Dr. Christopher Anzalone — Chairman, Chief Executive Officer & President

And also just broadly be careful about reading too much into where we are right now. We’ve only been actively in market for 10 weeks now, and so we’re still working with payers, we’re still working with physicians to get comfortable prescribing this. We’re still. Informing and educating patients and prescribers about the medicine. So we have a long way to go. Let’s see where we are more towards the end of the year. We have a pretty small sample set at this point.

Operator

Thank you. I’m not showing any further questions in the queue. I would now like to turn it back over to Chris for any closing remarks.

Dr. Christopher Anzalone — Chairman, Chief Executive Officer & President

Thanks everyone for joining us today. We look forward to speaking with you next quarter.

Operator

Thank you for your participation in today’s conference. This does conclude the program. You may now disconnect. Everyone have a great day.