IONS - NASDAQ
Ionis Pharmaceuticals, Inc.
IONS·NASDAQ
$73.82
+1.2%HealthcareBiotechnology
Ionis Pharmaceuticals, Inc. discovers and develops RNA-targeted therapeutics in the United States. The company offers SPINRAZA for spinal muscular atrophy (SMA) in pediatric and adult patients; TEGSEDI, an injection for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults; and WAYLIVRA, a treatment for familial chylomicronemia syndrome and familial partial lipodystrophy. It also develops medicines for various indications that are in phase 3 study, including Eplontersen as a monthly self-administered subcutaneous injection to treat all types of TTR amyloidosis; Olezarsen for patients with severe hypertriglyceridemia (SHTG); Donidalorsen for patients with hereditary angioedema; ION363 for patients with amyotrophic lateral sclerosis; Pelacarsen for patients with established cardiovascular disease and elevated lipoprotein(a); and Tofersen to inhibit the production of superoxide dismutase 1. In addition, the company develops medicines for metabolic diseases, infectious diseases, renal diseases, ophthalmic diseases, and cancer. It has a strategic collaboration with Biogen Inc.; and collaboration and license agreement with AstraZeneca, Bayer AG, GlaxoSmithKline plc, Novartis AG, Roche, Janssen Biotech, Inc., and Flamingo Therapeutics, Inc. Ionis Pharmaceuticals, Inc. was founded in 1989 and is based in Carlsbad, California.
At a Glance
Live SnapshotMarket Cap$12.20B
EPS-2.3800
P/E Ratio-31.02
Earnings Date07/29/2026
Earnings Call Transcript
IONS • 2026 • Q1
Operator
Good day, welcome to Ionis first quarter 2026 financial results conference call. As a reminder, this call is being recorded. At this time, I would like to turn over to Wade Walke, Senior Vice President of Investor Relations, to lead off the call. Please begin.
Wade Walke
Thank you, Sabrina. Before we begin, I encourage everyone to go to the investors section of the Ionis website to view the press release and related financial tables we will be discussing today, including a reconciliation of GAAP to non-GAAP financials. We believe non-GAAP financial results better represent the economics of our business and how we manage our business. We have also posted slides on our website that accompany today's call. With me this morning are Brett Monia, Chief Executive Officer; Kyle Jenne, Chief Global Product Strategy Officer; and Beth Hougen, Chief Financial Officer. Holly Kordasiewicz, Chief Development Officer; Eugene Schneider, Chief Clinical Development Officer; and Eric Swayze, Executive Vice President of Research, will also join us for the Q&A portion of the call. I'd like to draw your attention to slide three, which contains our forward-looking language statement.
Wade Walke
During this call, we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors contained in our SEC filings for additional detail. With that, I'll turn the call over to Brett.
Brett Monia
Thanks, Wade. Good morning, everyone, and thank you for joining us today. Ionis entered 2026 with significant momentum, which continued to accelerate through the first quarter of this year. Our performance to date highlights our strong execution across the business, which positions us to fuel substantial growth for years to come. We are very pleased with the continued success of TRYNGOL
Brett Monia
Together, TRYNGOL
Brett Monia
Today, based on HCP demand and payer research, we are increasing our annual peak sales estimate for olezarsen from greater than $2 billion to now greater than $3 billion, positioning olezarsen to become Ionis' first wholly owned multibillion-dollar medicine as the new standard of care for treating patients with severe hypertriglyceridemia.
Brett Monia
TRYNGOL
Brett Monia
We also remain on track for data from two major cardiovascular outcome trials from our partner pipeline this year. The pelacarsen Lp(a) HORI
Brett Monia
Our pipeline and our launches are delivering tremendous value, and we continue to strengthen our financial position. Even more importantly, we are well-positioned and committed to build on this success to drive far greater value for patients and our shareholders. With that, I'll turn the call over to Kyle.
Kyle Jenne
Thank you, Brett. As we enter 2026, Ionis is capitalizing on the exceptional launch momentum we generated in 2025 to drive even greater impact. We are set up for continued success with our independent launches. TRYNGOL
Kyle Jenne
Prescribers span a broad mix of specialties, including cardiology, endocrinology, and lipidology, which is exactly the prescriber base we want as we prepare for the broader sHTG population. Physicians remain highly satisfied with TRYNGOL
Kyle Jenne
That work consistently showed a clear understanding that preventing pancreatitis is the key treatment goal in sHTG and that current options fall short. Strong recognition of olezarsen's differentiated clinical profile, especially the acute pancreatitis data and the very low number needed to treat. HCPs have stated a high intent to prescribe across a range of patient types with initial use expected for individuals with triglyceride levels above 880 mg/dL or above 500 mg/dL with a history of acute pancreatitis or other high-risk comorbidities, including progressive cardiovascular disease and Type 2 diabetes. In line with our commitment to patient access and to a successful transition into the broader sHTG market, we recently announced an important pricing decision for TRYNGOL
Kyle Jenne
Effective April 1st, we set the new annual wholesale acquisition cost to $40,000, which applies to the current FCS indication and will be maintained for the anticipated sHTG indication across both doses. Importantly, by establishing a new price ahead of the June 30th PDUFA date, we are integrating olezarsen into 2027 payer contracting cycles, positioning us for accelerating access following approval. From a go-to-market standpoint, our full U.S. field organization is now in place, trained, and deployed. Today, that team is focused on supporting TRYNGOL
Kyle Jenne
We are seeing increasing adoption across all patient segments, patients switching from existing prophylactic therapies, patients who were previously using on-demand treatment, and treatment-naive patients. Our free trial program has been very effective, with high conversion to paid therapy rate to date. Just as importantly, feedback from both physicians and patients has been consistently positive, highlighting DAWN
Kyle Jenne
While it will take time to fully transition appropriate patients off legacy therapies, especially in a well-established market like HAE, the launch fundamentals give us confidence that DAWN
Kyle Jenne
On the back of the positive phase III results, we now have FDA priority review with the PDUFA date set of September 22nd, and our expanded access program is underway. On the commercial side, our focus has been on continuing to strengthen current relationships and build new relationships with the highly specialized community of leukodystrophy and rare neurology HCPs, further advancing partnerships with patient advocacy groups and ensuring the right support infrastructure is in place for diagnosis, treatment, and ongoing care. Our medical affairs team has been engaging with top leukodystrophy centers, sharing data and helping to build awareness of Alexander disease. Our marketing and access teams are finalizing the launch strategy. We will hire the customer-facing team closer to approval.
Beth Hougen
Thank you, Kyle. The strong operational execution you've heard about this morning translated into very strong first quarter financial results. We delivered year-over-year revenue growth and maintained disciplined expense management while continuing to invest in our current and upcoming independent launches. First quarter total revenues were $246 million, an increase of 87% compared to the first quarter of 2025. This increase was driven by year-over-year commercial revenue growth from TRYNGOL
Beth Hougen
DAWN
Beth Hougen
The strength of our balance sheet is the result of our prudent fiscal management, which enables us to make strategic investments as we advance and launch our wholly-owned medicines. Our Q1 performance underscores the value of our diversified revenue model, which combines growing commercial revenue with substantial and recurring R&D revenue from partner programs. Based on our strong year-to-date financial results, accelerating launch momentum and positive outlook for the rest of the year, we are improving our 2026 financial guidance. We now expect total revenue in the range of $875 million-$900 million, an increase of $75 million versus prior guidance, with total revenue weighted slightly more toward commercial revenues. For the first time this year, we are also providing product-level guidance for TRYNGOL
Beth Hougen
We expect TRYNGOL
Beth Hougen
In fact, we recently learned that the first patient-initiated treatment in the phase III program for salanersen, which triggered a $45 million payment we will recognize in the second quarter. Over the balance of the year, we also are eligible to earn additional milestones tied to sapablursen, bepirovirsen, pelacarsen, and other partnered programs as they advance. We expect our 2026 operating expenses to increase in the low teen percentage range compared to last year. This modest increase reflects our commitment to financial discipline as we bring multiple medicines directly to patients and advance our pipeline. The key drivers of expense growth will be sales and marketing investments to support TRYNGOL
Beth Hougen
As late-stage studies reach completion, we are redeploying our resources towards the drugs in our pipeline that we expect to fuel our next phase of growth. Our focus on improving operating leverage is enabling us to drop the full increase in revenue guidance to the bottom line. As a result, we expect a non-GAAP operating loss between $425 million and $475 million, a $75 million improvement over our previous guidance. This is similar to our 2025 operating loss after adjusting for the one-time sapablursen license fee we earned last year. We are projecting a 2026 year-end cash balance of greater than $1.6 billion. This reflects the repayment of the 0% convertible notes, which were due on April 1st.
Beth Hougen
The strength of our balance sheet, combined with our diversified revenue streams, supports our continued strategic investments in ongoing and planned launches as we advance our wholly-owned pipeline. Our financial outlook reflects accelerating commercial launches, a progressing pipeline, and a diversified revenue base, positioning us for continued growth and keeping us on track for cash flow breakeven in 2028. With that, I'll turn the call back over to Brett.
Brett Monia
Thank you, Beth. The first quarter and our outlook for 2026 underscore the strength of Ionis today. With two successful independent launches underway, two more independent launches anticipated this year, a robust pipeline advancing toward multiple near and midterm catalysts, and a solid financial position that supports the continued investments we are making to maximize the value of our commercial medicines and pipeline. With all these key elements in place, we're confident in our ability to accelerate revenue growth and deliver increasing value for patients and for all Ionis stakeholders. In closing, I wanna highlight that this week at Ionis, we are holding our annual Why Week. It's a time when our employees come together to hear directly from patients and caregivers about their personal stories and reinforce our purpose, which is bringing better futures to people in need.
Brett Monia
I've never been prouder of the impact we are having on patient lives and clinical medicine, and I'm even more excited about the greater impact we are positioned to make in the near-term and sustainably well into the future. With that, we'll now open the call up for questions. Sabrina?
Operator
Thank you. We will now begin the question-and-answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from Jessica Fye of JPMorgan. Please go ahead.
Jessica Fye
Hey, guys. Good morning. Thanks for taking my question. You once again raised peak expectations for TRYNGOL
Brett Monia
Yes. Jess, thank you for the question. Our increase in peak product sales for TRYNGOL
Brett Monia
As far as gross to net, we're not commenting on that at this time.
Jessica Fye
Thank you.
Operator
The next question comes from Mike Ulz of Morgan Stanley. Please go ahead.
Mike Ulz
Good morning. Thanks for taking the question, and congratulations on the progress. Maybe just a question on the TRYNGOL
Brett Monia
Kyle, would you take that, please?
Kyle Jenne
Yeah, Mike, appreciate that. I think what's important first is the strong performance that we saw in Q1 in terms of demand. It's the best quarter that we've had in terms of the FCS patient population, the number of scripts that were received, and the number of patients that are starting on therapy. That actually lends us a lot of confidence, not only in the FCS space, but also as we get closer to the June 30th PDUFA date in sHTG. I think it's indicating that there is a lot of interest in using olezarsen very broadly in this patient population. In terms of the launch in sHTG, we do know that there are a number of patients that are waiting, right?
Kyle Jenne
Especially the patients that have a history of acute pancreatitis, patients that are above 880 mg/dL, those are really the patients that we're gonna focus on out of the gate. The trajectory, I think, is gonna be modest at the beginning here in 2026. I think the revenue guidance that Beth shared, of $100 million-$110 million, is consistent with that expectation, we'll see it steadily grow over time with that focus being on the highest risk patient population. Some of the dynamics here, as typically seen, is it takes some time for the HCPs to be educated on the label.
Kyle Jenne
We've got to get those patients into those centers in order to get the prescriptions and then get the execution of the scripts to turn into patients on treatment. It'll be a build over time, and it will, you know, accumulate. We expect a modest and steady growth throughout the back half of this year.
Mike Ulz
Great. Thank you.
Operator
The next question comes from Gary Nachman, with Canaccord Genuity. Please go ahead.
Gary Nachman
Hi, guys. Good morning and congrats on the progress. Again, on sHTG, just talk about how you expect the payer access to ramp up, the timing of that, when you think it'll really kick in. You got updated guidelines for FCS. Will you be able to get that for sHTG as well? How long before you think you could expand to a less severe patient population over time? Thanks.
Brett Monia
Kyle, you wanna take, you wanna start? I can touch on the guidelines.
Kyle Jenne
Sure. On, on the payer access piece, Gary, you know, part of the price change that decision that we made on April 1st to change the WAC price to $40,000 is directly in line with working with those payers, right? It fits into the annual review cycle as they're getting ready for their 2027 decisions to be made. We believe that it will help us get ahead of sHTG a little bit, not only in 2026, but also will help us in anticipation of 2027. That being said, some payers or all payers will actually wait for the final label, right, before they make any payer coverage decisions, because they wanna see what the indication statement is.
Kyle Jenne
They wanna see what information is in the label, you know, including, you know, acute pancreatitis, and some of the other clinical study data that will be included in the label. It'll take a little bit of time. Some payers will say, you know, "We're not gonna review anything for six to nine months," for example. That's standard policy with some payers. We hope that we'll be able to get ahead of that with the payers that do review earlier, by making that price change and also with our current interactions that we're having leading up to the sHTG approval. We're gonna work quickly, and I think we're in a good spot right now in terms of the way that we're approaching the payers.
Brett Monia
Gary, to your other question, you know, we're very pleased by the fact that the cardiovascular treatment guidelines for FCS has singled out TRYNGOL
Brett Monia
We're also pleased by the fact that they have increased or updated their guidelines on Lp(a) testing, which bodes well for a potential positive phase III readout for pelacarsen and the subsequent launch. It's great news for patients, and it's great news for our pipeline. In terms of the less severe patient population, you know, we'll start with the over 880 mg/dL and over 500 mg/dL with history of AP. However, those same physicians that are treating that patient population also have patients that are 500-880 mg/dL, for example. The education will be ongoing. We're in the right segment of HCPs in terms of our targets, right? Focused on cardiology, endocrinology, and lipid specialists. They'll see a mix of those patients.
Brett Monia
I think some of those patients will already be picked up, especially if they have comorbidities, Type 2 diabetes and/or ASCVD. You know, the broader population will take a little bit of time just for awareness and for more of the data and information to come out and more experience of using olezarsen in the sHTG population. There's a lot of optimism and a lot of excitement around the category and around the use of a product like this because they've never seen the triglyceride-lowering effects that they're gonna see on top of standard of care, and they've never seen the outcomes in acute pancreatitis like they're, like they've seen with the CORE and CORE2 data.
Gary Nachman
Great. Thank you very much.
Operator
The next question comes from Jason Gerberry with Bank of America. Please go ahead.
Chi Fong
Hey, good morning. This is Chi on for Jason. Thanks for taking our question. On olezarsen sHTG, could you give us an update on the levels of liver fat you have observed in the CORE open-label extension studies? To what extent those open-label extension study data have been incorporated into the NDA as the FDA reviews the totality of the safety data? When would you expect to present the updated OLE data later this year? Thanks so much.
Brett Monia
Yeah, let me start, Chi. Thank you for the question, then I'll pass it on to Eugene. Maybe you could comment on where we are in the regulatory process for sHTG briefly. We're very pleased with the ongoing open-label extension data that we're continuing to accumulate with respect to MRI as assessment of hepatic fat fraction. As you recall, the increases in hepatic fat that we saw were relatively minor, there were no clinical sequelae associated with increase in the small increases in triglycerides. We strongly believe this is a non-target effect. It's consistent with other modalities that have taken that silencing approach in lowering ApoC-III in this patient population.
Brett Monia
It's completely logical based on the mechanism of inhibition of ApoC-III, which leads to a rapid and substantial clearance of triglycerides in large part through the liver. We've always felt that the observations in liver fat that we've seen here, again, no clinical sequelae associated, would be transient based on the liver just needing to have a little bit more time to clear out the liver that's being shunted through the liver. That's what we're seeing in the long-term extension data. We're seeing a return to baseline in liver fat. Again, no clinical associate sequelae associated with anything in the long-term extension.
Brett Monia
We look forward to presenting the data in the second half of this year at a major, medical, congress. Stay tuned for that. Eugene, you wanna provide an update on regulatory?
Eugene Schneider
Yeah. The application's under review. Everything is going as planned. Of course, the emerging safety data has been provided to the agency as part of routine day 90 safety updates. That's under review now with no questions asked so far.
Brett Monia
I'll also add that the discontinuations in the long-term extension are extremely low. We're seeing excellent compliance with long-term treatment in the open-label extension. Stay tuned. We're very much looking forward to presenting the results.
Brett Monia
We'd rather not comment on competitor data that's doesn't even exist yet today. I mean, we're looking forward to seeing any additional data that comes out this year, next year, and years to come in sHTG from other programs. All I'll say is that the phase III data that we presented at American Heart Association in late-breaking clinical trial session last year is incredibly compelling. It's a very high bar to me with respect to efficacy, with respect to safety, with respect to tolerability. 85% reduction in acute pancreatitis, which has resonated very well in the HCP community as Kyle highlighted earlier in his prepared remarks. 72% reduction in triglycerides on top of standard of care.
Brett Monia
We're focused on our program. We're ready to launch in June. You know, we're not, you know. I'll just leave it right there. Thank you.
Kyle Jenne
I'll just add, this is a large market, greater than 3 million patients that are potentially addressable here. We have a lot of confidence in the greater than $3 billion peak that we've put out there. That's really based on the phase III clinical trial outcomes that we have. It's based on our HCP demand research. It's based on the comprehensive, payer research that we've done and also the final pricing decision that we made. You know, we stand behind the increase, and we're excited about launching this program and getting it to as many patients as possible after the June 30 PDUFA date.
Operator
The next question comes from Jay Olson with Oppenheimer. Please go ahead.
Jay Olson
Oh, hey. Congrats on the quarter, and thank you for this update. Maybe I'll shift gears to DAWN
Brett Monia
Take that.
Kyle Jenne
Yeah, happy to, Jay. Thanks for the question. The competitive landscape obviously is evolving. I mean, there was some, you know, recent announcement as late as this week related to some of the dynamics in the marketplace. Keep in mind that in the United States, over 75% of the patients are currently on a prophylactic treatment. You know, this is a switch market as we understand the dynamics to be. We are really pleased with the momentum that we're seeing in terms of the interest in using DAWN
Kyle Jenne
The patient and HCP feedback has been extremely positive when they've been able to transition over to DAWN
Kyle Jenne
As early in the launch as we are right now, you would anticipate that the majority of patients would be on a four-week regimen. We will expect over time that they'll be able to progress onto an eight-week schedule as they're doing well on therapy, and we saw that in the clinical trial as well. Patients are doing great, momentum is very strong, and we're encouraged by what we're seeing in terms of the metrics with the launch at this point.
Jay Olson
Great. Thank you.
Operator
The next question comes from Moritz Reiterer with Guggenheim Securities. Please go ahead.
Moritz Reiterer
Hi, this is Moritz on for Debjit. Thanks for taking our questions. I'll continue on DAWN
Kyle Jenne
Yeah, I'd be happy to touch on that. Thanks for the question. You know, we had a very strong first quarter, $16 million in net product sales. This is a 128% increase over Q4. And I just spoke about the momentum that we're seeing in this market and the dynamics and also the receptivity by both HCPs and patients as they get started and gain experience with DAWN
Kyle Jenne
In terms of the new patient starts, the majority are switches, right. This is a switch market. Greater than 75% of the patients are on a prophylactic therapy in the United States. So it's gonna take time and time to build, you know, the revenues quarter-over-quarter. That it's happening the way that we expected it based on what we're seeing in the trends with Q4 as well as Q1. In addition to that, we are seeing some patients that haven't been on a prophylactic therapy before start on DAWN
Kyle Jenne
You know, those three patient segments I think speak to the fact that, the profile is very strong in what patients and HCPs are looking for. We have a differentiated mechanism of action, and our sales execution and market access teams are doing a great job in terms of supporting these patients to get started and stay on treatment.
Brett Monia
If you wanna start and then, Kyle take the second part.
Beth Hougen
Sure. On the collaborative revenue for this year, the way to think about it is we've raised our revenue guidance for the total year to $875 million-$900 million. That is slightly weighted towards commercial revenue. You can think about that split being slightly more weighted towards commercial revenue versus R&D revenues. Obviously, we've already realized and recognized $95 million in milestones, plus our ongoing collaborative revenue, which put us, you know, well over $100 million, closer to $130 million, $140 million for the first quarter. We've got a host of other milestones that we could potentially earn over the remainder of this year, plus our ongoing collaborative revenue from Waylivra cost share and amortization.
Beth Hougen
That is, you know, all the items that really give us confidence in the overall collaborative revenue for this year. For 2027, we've got, think about it this way, there's some very large potential milestones for approvals coming in 2027 with the phase III data that we're expecting to see from pelacarsen, eplontersen in particular. Those milestones are likely gonna drive collaborative revenue in 2027.
Brett Monia
Yeah. The, our launch preparations are going really well, right?
Kyle Jenne
Yeah. For zilganersen, I just, I want to, you know, just reinforce the excitement that we've got around this program. You know, this is gonna be our first anticipated neurology launch program. To be able to potentially bring this therapy to patients living with Alexander disease, I think is really an exciting opportunity for the community and also exciting for Ionis. In terms of the approach here, we're really gonna be focused on the patients that are currently on the clinical trial and helping get those patients moved over so that they can maintain treatment. The second area that we'll focus on are patients that are going to be enrolled in our expanded access program, which is ongoing and going very well.
Kyle Jenne
As, as you asked, what about the patients that are currently being identified and how do we help get those patients on treatment? We believe that there are approximately 300 or so Alexander disease patients in the United States. About 50% of those have been identified thus far. Some of them are on therapy that I just referenced. But we are doing some expanded work through our omni-channel and through our non-personal promotion campaigns to help identify more and more of these patients. Really what we want to make sure of is that they have the opportunity to experience zilganersen as the patients in the clinical trial did to potentially have the positive outcomes that were seen in that trial.
Kyle Jenne
Patient identification will be a key area of focus, and we're doing that while we're really making sure that we're gonna take care of the patients that are on treatment today and those that are awaiting treatment that have already been identified.
Kyle Jenne
At Q1, we continued to see very strong demand in terms of patients on therapy as well as new patient starts. Demand is still there. Oftentimes you see some January, February pressure as it relates to reauthorizations and the timing of those reauthorizations, which drove some of the pressure early in the quarter. We expect to see that pick up in subsequent quarters and in return to revenue growth as we move into Q2 and beyond in the U.S. You asked about the prefilled syringe. Really that's been put out there for optionality, right?
Operator
The next question is from Yanan
Yanan Zhu
Great. Thanks for taking our questions. Wondering for the FCS, you mentioned a great continued growth in demand. Could you help quantify that a little bit in terms of percent growth, given that, you know, the price change making it difficult for us to appreciate? And then, can you talk about how to think about sHTG in 2027? What kind of growth could we expect from, you know, the initial launch quarters in 2026? Obviously, you guided for peak revenue at $3 billion. Any sense that how long that might take? Any color would be super helpful. Thank you.
Brett Monia
Yeah. Yanan, let me start, and then I'll. Kyle already touched on what expectations are for 2026 launch in sHTG. He could cover that again, maybe comment on 2027. For FCS, as Kyle mentioned earlier, our first quarter of this year is our strongest quarter to date on patient demand and gaining access to TRYNGOL
Brett Monia
Launch trajectory?
Kyle Jenne
Yeah, I think what's important again is to mention that in 2026, the revenue guidance is $100 million-$110 million for olezarsen this year. We expect that to grow steadily over time. As I also described, the focus initially is gonna be on the high risk sHTG patient population over 880 mg/dL or over 500 mg/dL with history of AP. As we get into 2027, I would expect that more and more patients will start to come on board that are broader than that, Type 2 diabetes, ASCVD, et cetera, as I described. The launch momentum will build, and so will the patient base.
Kyle Jenne
As we get these patients on, as HCPs get experience in seeing the triglyceride-lowering levels and seeing the reduction in acute pancreatitis, that were demonstrated in CORE and CORE2. I think that experience and that evidence ultimately, will help us drive the trajectory into next year.
Yanan Zhu
Great. Thanks. Very helpful.
Kyle Jenne
Yeah, the real quarter-over-quarter growth is coming from the switch cadence that we are expecting to see, right? This being a switch market. We expect that to continue throughout the course of this year. That's the big driver, right? We know that, you know, that there's a need. We know that the profile of DAWN
Kyle Jenne
As HCPs are gaining experience, we're seeing more and more HCPs not only prescribe for the first time, but we're also seeing those that have used the treatment before use it again and again. I think that plus payer coverage tells us that we've got an optimistic outlook in terms of what 2026 looks like. I think the $110 million-$120 million guidance is in line with that expectation.
Brett Monia
We have time for one more question, please.
Operator
The last question comes from Myles Minter with William Blair. Please go ahead.
Myles Minter
Hey, thanks for sending me in and congrats on the quarter. Just on the TTR cardiomyopathy market, you know, Pfizer did settle for a potential generic entry from VYNDAMAX in mid-2031 versus something like, you know, in 2035. Does that change the way you or Astra
Brett Monia
Thank you, Myles. You know, the news that has been emerging this past week or so on genericizing tafamidis versus brand pricing has not come terribly surprising to us. It's consistent with our product sales guidance that we've put out there with Astra
Brett Monia
Combination usage, to your question, will also be utilized very, very, you know, robustly, especially if there's data supporting that combination usage will add further benefit to these patients that inevitably are progressing on current treatments. Our study is designed to actually generate the data that we believe could be convincing to HCPs who are asking the question whether or not combination of a stabilizer with a silencer will add further benefit to these patients. It's the largest study ever conducted in ATTR cardiomyopathy, and the combination subgroup is quite sizable. We're looking forward to the data in the second half of this year.
Brett Monia
We're prepared to submit the NDA by the end of this year and to launch next year. Thank you, Myles, for that. Thank you for the question, Myles. Thank you everybody who joined us today and participated on our call. We're looking forward to an outstanding year and sharing our progress along the way. Until then, thank you and have a great day, everybody.
Transcript from April 29, 2026
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