Milestone Pharmaceuticals Inc. Q1 FY2026 Earnings Call

Ladies and gentlemen, good morning, and welcome to the Milestone Pharma First Quarter 2026 Earnings Conference Call. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Michael Wood of LifeSci Advisors. Please go ahead.

Thank you, operator. Good morning, everyone, and welcome to the Milestone Pharmaceuticals First Quarter 2026 Financial Results and Business Update Conference Call. Earlier this morning, the company issued a press release providing an overview of its financial results for the quarter ended March 31, 2026, and recent corporate highlights. The release can be accessed on the Investors and Media section of the company's website, milestonepharma.com. Before we begin, I'd like to remind you that some of the information presented on this conference call contains forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause actual clinical programs, future results, progress, timing, performances or achievements to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties associated with Milestone's business and factors that could cause or contribute to such differences are described in detail in the company's filings with the SEC, including in the Risk Factors section of the annual report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 20, 2026. Speaking on the call today will be Joseph Oliveto, President and Chief Executive Officer of Milestone; Lorenz Muller, Chief Commercial Officer; and Amit Hasija, Chief Financial Officer and EVP of Corporate Development. In addition, Dr. David Bharucha, the company's Chief Medical Officer, will also be available on the call during the Q&A session. So with that, I'll turn the call over to Joseph Oliveto. Joe, please go ahead.

Thank you, Michael. Good morning, everyone, and thank you for joining us today. This is an exciting day as it represents our first analyst call reporting on our first ever quarter or, more accurately, partial quarter of sales since the commercial launch of CARDAMYST for acute episodes of paroxysmal supraventricular tachycardia or PSVT. Today, our prepared remarks will highlight 3 advances or updates since our last quarterly call. First, we'll provide our thoughts on the launch of CARDAMYST. Second, we'll discuss the initiation of our Phase III pivotal trial for etripamil for patients with atrial fibrillation and rapid ventricular rate or AFib-RVR. And lastly, we'll provide an update on our financials from our CFO, Amit Hasija. Let's start with the launch. To recap, CARDAMYST, the brand name for etripamil, was approved by the FDA on December 12 as the first and only rapid-acting self-administered prescription therapy for acute PSVT episodes in adults. Following approval, we immediately mobilized our launch plan. We quickly engaged our distribution channels such that CARDAMYST became readily available through retail pharmacies by the end of January. We then began promotion of CARDAMYST in earnest in mid-February, including the deployment of our national sales force of approximately 60 sales representatives. Launching within 2 months of the approval was an aggressive goal that we successfully met in Q1. Now a little less than 3 months since the launch, we're excited to share the emerging themes we've observed so far. Cardiology health care providers across the board, including physicians, nurses, nurse practitioners and physician assistants are consistently responding positively to CARDAMYST. It seems clear to us that the HCP audience we've engaged so far quickly understands the value that CARDAMYST brings to the patients with SVT due to its safety profile and ease of effective self-administration. Insurers continue to collaborate with us on pathways to coverage with the goal of adding CARDAMYST to their formularies. A great example of this is our earliest major win, Express Scripts National Formulary coverage. Express Scripts is one of the 3 major pharmacy benefit managers, or PBMs, which when combined with the other 2 major PBMs account for more than 80% of commercially covered lives in the United States. Perhaps most gratifying for us is the positive initial feedback we are receiving from the patient community and specifically those patients who received CARDAMYST. We gain these insights of patient experiences through our ongoing patient engagement activities, our social media monitoring and through physicians' and nurses' feedback, much of which is in the form of unsolicited text, calls and e-mails. The stories take the form of 2 flavors. The first being those patients who've used CARDAMYST and have had a positive experience during an event, but also interestingly, stories from some patients who relay excitement simply from having obtained CARDAMYST from their pharmacy and not even having used it yet. These patients describe having an increased sense of preparedness and security for when their next event will occur. All of these patient stories are a very valuable reminder of why we do what we do. So I'll hand it over to Lorenz to provide some additional details on the launch.

Thank you, Joe, and thank you to everyone joining us this morning. Building on Joe's overview, I will provide more color on our commercial rollout and sales progress of CARDAMYST in the first part of the year. Given that it's so early in the launch, I'll break total scripts out by month, which demonstrates steady progress month-over-month. Moving forward, we plan to report total prescriptions, unique health care practitioner writers and unique patients as quarterly figures. Through the end of April, we've captured approximately 600 total prescriptions. Specifically, February generated approximately 100 prescriptions and March was around 200, totaling approximately 300 prescriptions in our first partial quarter. In April, we're reporting around 300 scripts, or as many as the previous 2 months combined. Our data indicate that these prescriptions were written by over 400 unique health care professionals for approximately 560 unique patients. Our last key metric that we are reporting today and we will continue to report quarterly is lives covered by commercial insurance. With our early Express Scripts win announced at the end of March, we conservatively estimate that 25% of all commercially insured patients have quality coverage for CARDAMYST. Now for some perspective on what these numbers mean and why they're important at this early stage. In terms of prescription volume, while it's too early to forecast trends definitively, we are pleased to see data showing steady month-over-month growth. As Joe mentioned, prescriber reception has been very positive, which we see as a validation of the core value proposition for CARDAMYST. With both a well-established calcium channel blocker mechanism and a safety profile supported by robust clinical data, we believe that these first scripts written by our target providers tell us that prescribers see CARDAMYST as an important and needed solution for their patients with PSVT. As I said, through the end of April, over 400 unique prescribers have written approximately 600 total prescriptions for CARDAMYST. We view this breadth as a strong leading indicator of the appeal of CARDAMYST among providers. When a new therapy like this is adopted across a relatively wide physician base from the onset rather than just a narrow group of early adopters, we believe it signals that the value is clearly resonating broadly. Thus, we are building a strong, receptive foundation of prescribers who, as coverage expands and their familiarity with CARDAMYST increases, should increase their prescribing depth over time. I will add that many of these prescriptions are coming from physicians who have met with one of our sales representatives only a few times. This is important as we believe in pharmaceutical launches, early trial after 1 or 2 interactions is a positive signal about the strength of the clinical story and a physician's interest in the product. This is something our commercial teams specifically aspire to from the onset, and we believe it reflects the compelling nature of the profile of CARDAMYST and its value proposition. As our reps build frequency and deepen their relationships through repeat visits, we have every expectation that this will be a driver of growing prescription patterns. Now to the third metric, coverage. On March 31, we announced that Express Scripts, one of the nation's largest pharmacy benefit managers, added CARDAMYST to its commercial national formularies. I want to highlight the importance of this earlier than predicted success. This is the first contracted formulary acceptance of CARDAMYST by a major payer. In the landscape of commercial drug launches, getting a major PBM formulary placement within the first quarter of a launch is a significant achievement. We see this as clear validation of the clinical and economic value to payers, particularly in terms of our clinical data, illustrating the potential of this drug to reduce health care utilization, including emergency department visits and hospital admissions. The Express Scripts coverage decision means that we now have approximately 1 in 4 commercially insured lives covered. We believe most of that coverage is quality coverage, meaning patients are more likely to be approved at the point of sale rather than navigating an overly onerous prior authorization process and we will be able to refill a prescription multiple times to treat subsequent episodes of PSVT. We are actively negotiating with other major PBMs and health plans. And while I won't get ahead of any specific decisions, we are committed to continuing to expand contracted coverage, and we expect further announcements as those discussions progress. So to summarize where we stand across our 3 key metrics, the breadth of new prescribers and early physician acceptance gives us confidence that we are gaining traction. We are building momentum, and we will continue to plan for an acceleration in prescription volume as our launch progresses. These measurements of growth will be driven by increased promotional frequency with our target physicians, continued pull-through from our first major coverage win and additional anticipated positive coverage decisions. I'll now turn the call back over to Joe to update on progress in our clinical development program.

Thank you, Lorenz. I'll turn now to the next major advancement for Milestone and for etripamil. Namely that we have initiated our Phase III trial for atrial fibrillation with rapid ventricular rate or AFib-RVR named ReVeRa-301. This ReVeRa Phase III registration trial is based firmly on the successful performance of etripamil in our AFib Phase II study. In that trial, patients on etripamil demonstrated a statistically significant and clinically meaningful reduction in their ventricular rate compared to placebo and also showed symptomatic improvement. The design of our Phase III AFib study, ReVeRa, uses the same approach of patient self-administration of drug and operational study conduct as our successful Phase III trials in PSVT. Specifically, the Phase III AFib ReVeRa study is a double-blind, placebo-controlled, event-driven trial in which the patient will self-administer the drug outside of the health care setting. The study employs the same 70-milligram dose and repeat dose regimen that is already approved for CARDAMYST for SVT and many of the operational conduct components are the same as those that were used in the SVT program. Regarding status, we are labeling clinical study drug. We have begun contracting with key clinical research sites with whom we've had successful experience from our PSVT trials and have completed contracting with several. We're actively recruiting additional trial sites in several geographic regions with a focus on the U.S. and the trial has been posted on clinicaltrials.gov. We expect to enroll our first patient into this trial in the second half of this year and look forward to providing further updates as the ReVeRa-301 study advances this year. I will now turn the call over to Amit for a financial update.

Thanks, Joe. We have a strong balance sheet, including approximately $184 million in cash, cash equivalents and short-term investments as of March 31, 2026. This compares with $106 million at December 31, 2025. We believe our cash balance provides sufficient runway to support both ongoing CARDAMYST launch activities and our operations into the second half of 2027, including the execution of the ReVeRa-301 study. The higher cash number is primarily the result of $75 million cash payment we received in January in connection with our royalty purchase agreement with RTW, as well as approximately $19 million in net proceeds from ATM sales and Series A warrant exercises that took place during Q1. Our operating cash burn during Q1 was approximately $23.7 million. Product revenues in the first quarter of 2026 were $0.2 million. R&D expense net of tax credits was $3.3 million in the first quarter of 2026 compared to $5 million in the first quarter of 2025. The decrease compared with the prior year was primarily due to a decrease in the outside service costs related to drug development and research. G&A expense was $4.8 million in the first quarter of 2026 compared to $5.2 million in the first quarter of 2025. The decrease was primarily due to lower professional costs, partially offset by an increase in personnel costs. Commercial expense was $15.8 million in the first quarter of 2026 compared to $10.4 million in the first quarter of 2025. The higher commercial expense was primarily a result of additional personnel costs, professional costs and other operational costs related to the launch of CARDAMYST. Net loss for the first quarter of 2026 was approximately $26.1 million or $0.20 per share compared to $20.8 million or $0.31 per share in the first quarter of 2025. I will now turn the call over to Joe for some concluding statements.

Thank you, Amit. As we reflect on the quarter, we are proud of the early execution of our launch and the progress we are making in establishing CARDAMYST as a novel treatment for PSVT. While we're still in the early stages, the initial indicators we are seeing give us confidence in the opportunities ahead with the PSVT launch and with our AFib-RVR Phase III clinical development program. Our focus remains clear: driving disciplined commercial launch execution, including expanding payer access, advancing our clinical development program and managing our resources responsibly. We believe these priorities position us well to continue our momentum over the course of 2026 and beyond. Thank you again to our team and our shareholders for your continued support. That concludes our remarks, and we will now open the call to questions.

We will now begin the question-and-answer session. We take the first question from the line of Ritu Baral from Cowen.

I wanted to ask about the 400 unique prescribers and the initial Rxs and NRxs that have come in. Can you talk about the mix of prescribers at this point and how you expect that mix to evolve, especially as you continue your commercial targeting? How do you think that will reflect downstream on the mix of patients that you end up getting? Also, according to our calculations, while you have mentioned that you're giving away free drug, it doesn't look like you've given away that much. Can you discuss the receptivity of that program, whether bridging programs have been offered, and whether that will continue to be part of the 2026 effort?

Yes. Great, Ritu. Great to hear your voice. Thanks for listening in on the call. And maybe I'll start a little bit, particularly with the prescriber mix and ask Lorenz to comment a little further on what that means for downstream as we're thinking about it now. And then also Lorenz to give a little bit more color on how much free drug we're giving away and how we think about that going forward. So we've always said that this is primarily driven by clinical cardiologists. That's where the majority of these patients live in terms of their management. We always thought that EPs, electrophysiologists, could be a bigger writer in the first year, primarily because we don't have or are not expecting a lot of refills in the first year. So that was our guidance before launch. And I would say we're largely seeing that. So far, we've seen approximately 50% of the scripts to date written by cardiology and about 25% written by electrophysiology. The other 25% is really a combination of nurse practitioners, physician assistants, a few primary care physicians, really not many at all and just an other bucket that are not classified in our data. So it seems to be playing through with how we've thought about it prelaunch with the idea that while electrophysiologists are writing only 25% currently, that's a big number relative to where they'll be over the long haul, and they're influential, as you might be aware. So it's good to have that prescribing behavior because those are the folks that will be called by cardiologists asking about the drug. They're important to P&T committees, they're important in guideline discussions, all those types of things. Lorenz, maybe if you want to comment a little further on how you see downstream going and then move over to the free drug program.

Sure. Happy to do that. Ritu, thanks for the question. Joe is exactly right in that we expected the majority of early scripts to come from cardiology and maybe favor electrophysiology somewhat as the thought leaders. Over time, we would expect to continue to see the majority of our prescriptions coming from cardiology, clinical and interventional cardiology. Electrophysiology will continue to use it, but their use case is more focused on bridging patients to an ablation, and so there wouldn't be as much reuse of the drug, assuming those ablations were successful. So I think over time we will see two dynamics. One is the percentage of cardiology scripts that is written by clinical cardiologists and interventionalists will increase relative to total, including EPs. And I do think the second dynamic over time is we will start to see more APPs, so nurse practitioners and physician assistants. As practices get comfortable that the cardiologists in that practice are comfortable prescribing the drug, which we are seeing evolve relatively quickly, APPs will become more the day-to-day managers of these patients and the prescribers. I also think, finally, over time, so measured in years, not months, primary care will start to adopt more, although they only represent roughly a quarter to a third of the prescribing population. What we're seeing early on is primary care that looks more like cardiologists than true primary care. Over time, primary care will also start to write more because they're seeing some of the younger patients who don't have other cardiovascular disease; the only form of cardiovascular disease those younger patients have is PSVT. To your second question on free drug quantities, our goal in the launch has always been to ensure that when a script comes in, the payer is notified that there's demand there because that helps us ultimately convince payers that there is demand and therefore that they want to cover the drug and make themselves available for those rebates. So we don't just provide free drug right out of the gate. We go through the process and then the pharmacist or the physician's office has to fill out the paperwork for prior auths or medical exception, which is where most of the scripts come through ahead of coverage. Only where those prior auths or medical exceptions are not granted do we then come in primarily with assistance. I was pleased to see that we are week-over-week seeing growth in the number of scripts that are actually filled. That is in part a sign of expanded coverage, meaning the ESI coverage decision win, but also somewhat our ability to now convert patients, meaning at the end of the chain, if they don't pass medical exception, we are there to catch that patient and allow them to use the drug.

So this is more sort of like true bridging rather than like a sampling effort. Is that correct?

Yes, I think that's accurate, Ritu, yes.

We take the next question from the line of Ted Tenthoff from Piper Sandler.

Congrats on the nice first-quarter launch. Lorenz, I always appreciate all the detail and color you provide. My question is about ReVeRa-301 and getting a sense of it — I know you're just starting and kicking it off, but could you walk us through the patients you're enrolling and what we should expect in terms of how long it might take to enroll the study?

I'll handle this. David Bharucha is on the line if there are further questions. Atrial fibrillation is a huge market — about 10 million patients in the U.S. alone and growing. We are specifically looking for patients with AFib who experience rapid ventricular rate events, defined as heart rates above 100 beats per minute that commonly last for some time and are symptomatic. The ultimate value proposition for CARDAMYST is to reduce that elevated rate toward a more normal level, not necessarily completely normalizing it, and to reduce symptoms. By doing so, we hope to enable patients to manage these episodes at home rather than going to the emergency department for IV calcium channel blockers like IV diltiazem. We will evaluate that in the study by enrolling patients with a history of AFib with rapid ventricular rate, ideally those with higher and symptomatic rates. The study is powered at 90% to achieve a 0.05 significance level based on the second endpoint, which is symptomatic improvement. We expect a total of roughly 150 to 200 AFib-RVR events and estimate the study will take about two years from first patient enrolled to data readout. That timeline and size are based on our experience with the PSVT program, our Phase II AFib experience in the emergency department, and operational learnings from the outpatient PSVT program. The study will be multi-country and multisite and may enroll up to about 600 patients in the funnel to yield those 150 to 200 events.

We take the next question from the line of Mohit Bansal from Wells Fargo.

Congrats on all the progress. I want to dive a little bit deeper in the Express Script formulary decision. Can you remind us what kind of prior auth is required to make it available for the patient? And then if I do the math on like number of prescriptions and then the sales you are reporting, it seems like pretty high, almost $800 per script number. So is that, Lorenz, like you said, that you are trying to make sure that payers do see it and you are not providing free drug just yet. Is that the reason why the gross to net seems to be really good here?

Yes. I think those maybe are questions for Lorenz to provide color. What I'm hearing, Mohit, is you really want to know about ESI coverage and what that looks like in terms of how quality is it and what's the prior auth process was the first question. And then the second question, let me just make sure I got it correctly. Are you calculating something like $800 per script? Is that what I heard?

Sure. Yes. So ESI is one of the three big pharmacy benefit managers. It rolls up under Ascent. By signing a contract with them and getting coverage, that allows, as I mentioned on the call, about one in four commercially insured patients to have coverage for the drug. That means all the plans for which ESI administers a pharmacy benefit will now have the ability to make a coverage decision and then fill the drug without all the different steps I mentioned in the previous question from Ritu, such as an onerous prior authorization process or a medical exception, which take time and require a lot of work from the physician or the pharmacy to complete. With Express Scripts, we think the majority of that will be what we call quality coverage. I cannot say all of it because there are many different benefit designs under ESI and not everyone opts into the offer, but we are confident the majority will. Our definition of quality coverage is essentially that it is not onerous to prescribe the drug and get it filled, meaning the physician’s office does not have to do a ton of paperwork, and in some cases no paperwork is required for the product to be filled at the pharmacy. It also means there is the ability for the patient to refill the drug a number of times. Most patients have more than one episode a year, and if they have success with the drug, which we are hearing anecdotally from patients, they will want to get a refill. We do not want coverage to disproportionately limit the amount of product a patient can get, but we also understand that payers launching a new therapy might be concerned about a patient using it 30, 50, or 80 times a year, which we are not expecting to see. So again, quality coverage means limiting the amount of prior authorization paperwork to as little as possible, and ideally anything that is required is adjudicated at the pharmacy rather than requiring the doctor or the doctor’s office to fill out a lot of paperwork, and that the quantity limits are not overly draconian. We are happy if a patient can have up to six or 12 fills in a year, although in a launch year, as we have said, we expect most patients to use this a couple of times. On the second part of the question, I was taking note. I think, Mohit, the confusion is we had announced on the earnings call that we have around $200,000 in net sales and that that is coming from 600 prescriptions, not 300. So I think the math you did was a little off in terms of the dollars per prescription. It is, in fact, a little bit lower than the range we have often quoted of $500 to $1,000, but that is because we are in the first quarter of launch, and we are seeing a lot more use of denial conversion or situations where medical exceptions are not going through and we do want those patients to have access to the drug. We expect that number to increase steadily over the next few quarters to get into the range of what we have reported previously.

We take the next question from the line of Tiago Fauth from Raymond James.

I just want to talk a little bit more about the acceleration in prescription volume. So you are seeing that steady pace of adds, an increase in adds. I'm curious, and again it hasn't been that long, but the Express Script agreement — can we expect to see some degree of acceleration relative to that? Could that quality coverage actually increase the pace of net adds? I have a follow-up about the depth of prescribers and the patient journey. This question is mostly about the ramp for the launch. What are some of the key levers that will lead a physician to prescribe to more patients and for a patient to actually utilize this more than once a year? I know there's probably a cap there, but again, thinking about depth of prescribing and utilization per patient, what are some of the levers early in the launch? I understand, I'm just trying to think longer term.

Okay. So Tiago, great for jumping on here and for the questions. Again, I'll start, Lorenz. I don't know if I caught all those questions at the end; I might have to ask Tiago to come back to a few of them. But certainly ESI, and remember Tiago, we got that right at the end of the quarter, so right at the start of April. These first-quarter numbers are essentially without coverage or with very little coverage, whatever you get initially out of the gate. That's the first point. We are seeing coverage generally, and ESI is a good early win that provides two things. First, it improves pull-through once a prescription reaches the pharmacy because the paperwork, as Lorenz explained, is much reduced, if needed at all, allowing the prescription to be processed and filled. Second, and more intangible, physicians are more likely to prescribe when there's less hassle. In the field, doctors consistently ask how to obtain it, whether it's covered, whether it's in Epic, which pharmacy carries it, what they need to do, and what their staff must do. It's intangible, but I believe coverage will help, and we're careful not to burden offices. If a doctor has to complete multiple forms and the patient still doesn't get the medication, it frustrates them, so we try to avoid that. As coverage increases and paperwork declines, we expect more initial prescriptions. That thought is in physicians' minds, so yes, it should accelerate uptake. However, Express Scripts is only one of three major commercial payers. About half our patient base is commercial and half is Medicare, so ESI's coverage represents roughly half of the 25% total addressable market coverage we reported so far — meaning there's still a long way to go on that front. That was a lot on that. Lorenz, maybe you can move on to the second and third questions.

Yes, I will. And I'll just add one other thing on the acceleration. You were focused a lot, Tiago, on the coverage part of acceleration. And we certainly think broader coverage will be for the reasons Joe mentioned, a driver of acceleration. But the other one is promotional response, right? Our reps have been out there now for a couple, three months. They've seen a lot of their customers only once or maybe twice. And as they get more frequency on those customers and as they reach more of the customers in the rather large territories that they have, we do expect that to result in more prescription writing. And that's a little bit of answering to the second part of your question, which you were asking about 2 parts, as I heard. One was what are the tactics or the levers where target physicians will write more than they're currently doing. Most of our physicians based on the numbers we reported this morning, have written a script, although about 25% have written more than that. And then the second part was how are we going to drive utilization of the patient where they fill more than one script. And both of those will happen over time. And they're related to both the physicians' awareness and willingness to trial, which we're seeing, but then translating the willingness to trial to usage where they use it on more patients and where patients actually come back after they've had a successfully treated episode or where they ask for a second script to be filled even before they have a first episode because they want to have access to the drug. So with the payers being willing to give patients, say, more than one dose at a time, we do believe patients will go in and fill a second or a third script in order to be able to have the drug on them, in the office, at home, in close proximity. So when they have that unexpected episode, they can treat it quickly. So I think all of that, the answer is time and effort for us to continue to drive promotional response, getting in front of HCPs, prescribers and making sure they're aware and trialing in appropriate patients. And then we do think over time, as patients have a successful experience with the drug, we've seen this already in some of the anecdotal social media listening we've been doing. They'll come back to the docs say, 'Hey, that really works for me. Could you write me another script? I'd like to refill.' That's sort of a dynamic. We will also accelerate our adoption.

We take the next question from the line of Brandon Folkes from H.C. Wainwright.

Congrats on all the progress so far. Maybe just 2 for me. Can you talk about how you're thinking about targeted DTC spend going forward here? And then last year at your Commercial Day, you provided a lot of really insightful detail on how you envisioned the launch. Can you just talk about if the launch is tracking sort of within all those expectations? Anything there that you see different today? Obviously, Express Scripts coming on very early on. But yes, just put in context how you see the launch today versus sort of how you framed it last Feb.

Sure. Again, I think I'll just provide a high level. And then, Lorenz, these are really questions for your insights. I would say with regard to targeted DTC spend, hopefully, what came across in our plans before we got the approval, Brandon, was we're trying to be very thoughtful around how to use the dollars and use them in areas that are really going to drive the most bang for the buck. And things like targeted DTC or what we call DTP, direct-to-patient as well as even things like nonpersonal promotions to physicians. Everyone is aware, we have about 10,000 targets. I'm pretty sure everyone is aware that we're not going to get to all those targets. There are no C physicians in our target call base. And that lends itself to nondirect promotion or what we call nonpersonal promotion. So these are ability to get the message and the information to these offices that we can't have our reps come in on, right? And it takes a little longer to get to those offices. But the thought is behind both of these tactics, if you will, is let's make sure we have enough coverage and enough general awareness through the more routine routes of our sales representatives and working through the coverage system before we really start driving patients into the office. So it's always been very tailored that way, and we still expect that to happen. We are, though, having pilots in those areas such that when we are ready to turn on the spigot, if you will, and open up spends on those areas, we know where and how to spend it. So that's the general philosophy of how we're approaching these things. But Lorenz, maybe you can provide a little bit more color specifically to the DTC spends that Brandon is talking about.

Sure. So we've always said that this is a patient-driven market. Everything we're seeing in the launch so far suggests that that was a correct assessment. It's really a question of timing rather than if; it's when. What I mean by that is you don't want to drive patients, in any therapeutic area, into the HCP office or into a prescriber office if the prescriber is not aware of the new drug. That always becomes problematic. It's one of the reasons why DTC ads are not allowed in the launch year on television. To be compliant with that, which we believe and agree with, we've done some pilots, as Joe alluded to, which are primarily targeting tools that are already in doctors' offices, whether they're wallboards or other media, to generate some awareness among patients and see if we can actually raise awareness through those tactics. They're not expensive, and there are things that are very scalable. If we invest in that for two or three months and see a positive ROI, then we'll know we can do more of that later this year or starting next year to drive patient awareness because we're confident that if a patient is aware of a new treatment for SVT and there's no competition, they will likely go into the doctor and ask for it. Where they do ask for it, more than likely it will be granted. More broadly in terms of patient activation, those pilots are just awareness-generation tactics. In terms of customer relationship marketing—building educational resources, capturing patients by advertising to them, building a relationship and marketing to them, the classic direct-to-patient tactics—we are building those capabilities and expect to bring them online later this year or early next year, when we have sufficient awareness and trial among cardiology so clinicians won't be surprised or irritated when a patient comes in asking for the drug. That's how we think about the staged rollout of a very important long-term tactic that I think will drive the business: patient activation. Regarding the second part of your question, Brandon, about how the launch is tracking from our view, you captured the three broad areas. On payers, we think we're a little ahead of expectations with the early win from ESI. We're in active discussions with the other big payers and are pleased with the level of engagement. You can't get to a contract or coverage if payers don't want to talk to you, and I can confidently say we are talking to all the major payers, both the commercial ones—the big three PBMs—as well as the Medicare payers, where we're positioning ourselves to be within the consideration set for formulary decisions in 2027. So I'd say we're ahead of plan. On cardiologists and HCP reception, we are hearing very positive feedback, and Joe and I have seen it in the field. People seem very happy with the efficacy and safety data. It doesn't take long in the field for a doctor to say, "Okay, I get it. This looks really interesting." Then the conversation moves to what kind of patient and when they can write it. We mentioned earlier in the pre-approval period that we were targeting around 10,000 doctors. We have currently engaged with about one third of those doctors, meaning a sales rep has been in one or multiple times to talk and make them aware of etripamil. Think of it as around 3,000 to 4,000 doctors who have actually been engaged by a sales rep. We have around 400 writers, and we're seeing north of a 10 percent prescribing rate among the people we've reached. This early in the launch, two to three months in, we're quite pleased with that metric. We expect it to grow as we increase reach and frequency with these customers. That's an early metric that suggests the launch is tracking as we hoped. The patient response is the third important area. So far, what we've heard is anecdotal from social media listening about how patients are responding. Not many patients have gotten a prescription and actually used the drug given the nature of the episodes, but some have, and the response has been overwhelmingly positive. That's a very good sign that patients are having a good experience, will report that back to their doctor, and will seek refills.

We take the next question from the line of Dennis Ding from Jefferies.

This is Georgia on the line for Dennis Ding. A quick question on the commercial strategy and launch. You mentioned many of the early prescriptions are coming from just 1 or 2 rep interactions. Can you provide more detail on just how many touch points you're seeing on average today and how you expect that to evolve as the launch matures to hit those 10,000 docs you just spoke about? And any plans for a sales force expansion to do that? And then relatedly, are you seeing differences across prescriber segments such as the EPs versus the cardios in terms of the number of interactions required to drive initial and repeat prescribing? And then finally, when would you expect your sales force to reach max productivity?

Okay. Yes. I think some of these, Georgia, will be a little tough just given how early we are, especially when we want to talk about repeats. Really, we're just in the initial stages there. But Lorenz, a host of good questions for you to speculate on, I would say, some of these things.

Fair enough. Thanks, Georgia, for the questions. In terms of the early prescriptions, yes, you're correct. We know many of our customers have seen a sales rep once or twice, although a number of them have seen them dozens of times. It really varies a lot in terms of access, so it is definitely too early to calculate promotional response. We can get an anecdotal sense — for example, a doctor got one detail and then wrote a script — and we have seen that a number of times. That is promising and suggests the drug is not complicated to use, and there do not appear to be new mechanism or safety concerns that would prevent a doctor, based on an initial encounter or two with a sales rep, from being willing to write the drug and follow through to get it filled. So that feels pretty good early on. Over time, though, we want to reach more doctors than the roughly one-third of our targets we've already reached, and we want to increase depth so the drug becomes more top of mind and each doctor would write for more than one patient over time. Our launch sales force strategy remains the same: we went out with a sufficiently sized sales force, about 60 reps, where we can confidently demonstrate demand without getting ahead of coverage. We do not want to frustrate physicians by having them write scripts they cannot get filled and then have them stop prescribing until we have broader coverage. As we gain coverage, and particularly next year if we get some Medicare coverage, that will be the time to consider expanding the sales force. At the same time, we are thinking about ramping up patient activation, so decisions will be made around what gives the biggest bang for the buck. Later this year we'll have a better sense of promotional response for our existing promotion — how much we pay for a rep and how many scripts that rep generates — and we'll also learn from some pilots how effective patient activation is. If we identify and market directly to patients, will they go get a script? We can measure that because these are largely digital tactics. Based on those results, probably later this year or early next year we'll decide where to deploy resources. Expansion of the commercial effort will be ROI-driven and not just focused on the sales force. You also asked about differences in promotional response between cardiologists and electrophysiologists. It is too early to calculate that from data, but from being in the field — and as Joe mentioned about his own time in the field — the use case and the discussion with an EP is a little different than with a cardiologist, and we've trained our reps accordingly. We are not seeing any increased resistance to prescribing or any strong differences in enthusiasm between cardiologists and EPs; it's just that they think about using the drug differently. A cardiologist is more likely to manage a newly diagnosed patient who does not want an ablation or an existing patient dissatisfied with current therapies, while an EP is more likely to consider the drug for a patient queued up and waiting for an ablation. Regarding sales force productivity and maximizing that, it is again too early to calculate. Conventional experience suggests that when you deploy a new sales force, you need at least three to six months before they can reach all their customers, hit their reach targets, and achieve sufficient frequency to put customers on their adoption paths. I would expect the second half of this year is when we'll have a better sense of that, and that's also when we should be able to start calculating promotional response, which will inform the investments I mentioned earlier.

I think there's one thing to add, Georgia, is the difference, at least from my experience being in the field now, it's hard to get through a discussion with an electrophysiologist about CARDAMYST for PSVT with them not wanting to bring up atrial fibrillation and they, almost to a person, do. And we know that. We know that it's driven largely by the fact that their ablations in atrial fibrillation are not nearly as successful as they are in SVT. And it provides a nice bridge for us then to have that discussion with them with our medical team. We refer them over to the medical side of the house and the clinical side of the house to be able to engage them around what we're doing on the development and the Phase III program for AFib. So that's the other main difference between the 2 groups, cardiology and atrial fibrillation. We want to be super compliant and make sure we drive the message home that this drug is for PSVT. It's approved there. There's a high medical need there. To Lorenz's point, we do talk about the right patients. Maybe it's that patient getting a bridge to an ablation or that patient who's trying to decide on their ablation. That's the discussion. But it really is obvious that they're really looking forward to our development in AFib and that gets them excited and gets our clinical team excited.

Ladies and gentlemen, as there are no further questions from the participants, I would now hand the conference over to the management for their closing comments.

Thank you, operator, and thank you all to the investors who called in today and those who listened in. And I appreciate all your interest in Milestone and look forward to updating you as the launch progresses. Have a great day.

Thank you. Ladies and gentlemen, the conference of Milestone Pharma has now concluded. Thank you for your participation. You may now disconnect your lines.