Milestone Pharmaceuticals Inc. (NASDAQ:MIST) Q1 2026 Earnings Call Transcript

Milestone Pharmaceuticals Inc. (NASDAQ:MIST) Q1 2026 Earnings Call Transcript May 13, 2026

Milestone Pharmaceuticals Inc. misses on earnings expectations. Reported EPS is $-0.2 EPS, expectations were $-0.03.

Operator: Ladies and gentlemen, good morning, and welcome to the Milestone Pharma First Quarter 2026 Earnings Conference Call. [Operator Instructions] 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.

Michael Wood: 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.

Joseph Oliveto: 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 physicians’ 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.

Lorenz Muller: 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.

Joseph Oliveto: 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.

Amit Hasija: 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.

Joseph Oliveto: 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.

Operator: [Operator Instructions] We take the first question from the line of Ritu Baral from Cowen.

Q&A Session

Ritu Baral: I wanted to ask about the 400 unique prescribers and sort of the first Rxs, NRxs that have come in. Can you talk about the mix of prescribers at this point and how you expect that sort of evolution of the mix, especially as you continue your commercial targeting? And how do you think that, that will sort of reflect downstream on the percentage of patients — I’m sorry, the mix of patients that you end up getting? And then 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 free drug. Can you talk about sort of the receptivity of that program, and has sort of bridging programs been offered and will that continue to be a part of the 2026 effort?

Joseph Oliveto: 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, physicians’ assistants, a few PCPs, 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 guidelines, 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.

Lorenz Muller: Sure. Happy to do that. Ritu, thanks for the question. So 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 2 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 physicians’ assistants.

As practices get comfortable that the cardiologists in that practice or cardiologists 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, I do think primary care will start to adopt more, although they only represent roughly 1/3 or 1/4 or 1/3 of the prescribing population. What we’re seeing is early on is primary care that look more like cardiologists than true primary care. And I do think over time, primary care will also start to write more because they’re seeing some of the younger patients where they don’t have — they only have — 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, that 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 — avail themselves of those rebates. So we don’t just provide free drug right out of the gate. We go through the process and then the pharmacist and/or the physician, the office have to fill out the paperwork for prior auths or medical exception, which is where most of the scripts come through ahead of coverage. And only where those prior auths or medical exceptions are not granted, do we then come in primarily with assistance.

So I would say I was pleased to see that we are week-over-week seeing growth in the number of scripts that are actually filled. And 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.

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

Lorenz Muller: Yes, I think that’s accurate, Ritu, yes.

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

Edward Tenthoff: Congrats on the nice first quarter launch. Lorenz, always appreciate all the detail and color that you provide. My question has to do with the ReVeRa-301 and just a sense of — I know you’re just starting and just kicking it off, but walk us through a little bit more in terms of the patients that you’re enrolling and maybe what our expectations should be in terms of how long it might take to enroll the study?

Joseph Oliveto: Sure. I’ll handle this. Of course, if there’s any further questions, David Bharucha is on the line. So very importantly, and just a reminder for the audience is atrial fibrillation is a huge market. Current estimates about 10 million patients with atrial fibrillation in the U.S. alone and growing. Expectations are that this number will increase in the short term here. And very important to realize that we are looking for patients that have AFib are characterized with AFib and importantly, are characterized with AFib and events of rapid ventricular rate. These are events above 100 beats per minute and commonly last for some time and are very importantly, symptomatic to the patient. The ultimate value prop for CARDAMYST, Ted, is really to help resolve that elevated rate, bring it down towards a more normal rate, doesn’t have to get all the way to normal and reduce symptoms.

And by doing that, we should enable the patient to manage these episodes at home and not have to go to the emergency department for most commonly IV calcium channel blockers like IV diltiazem. That is the value prop. We want to follow that in this study. So very importantly, we’re looking for patients that have a history of AFib with rapid ventricular rate, ideally more elevated rates and very importantly, symptomatic rates. So that’s what’s really the driver for this study in the patient population we’d like to see. We believe that the study should — well, it is powered at 90% to deliver 0.05 based on really the second endpoint, which is symptomatic improvement. We believe that powering it that way should deliver a successful results with a total size of somewhere in the range of 150 to 200 total events.

And we believe that, that study should take around 2 years from start from our first patient enrolled to data. That’s our current estimate. There’s a lot of variables in there, but it’s driven primarily off of our experience with our PSVT program, our experience with our Phase II program in AFib and trying to triangulate around what we saw in both of those programs both with the AFib experience in the emergency department, but also operationally the PSVT program in the outpatient setting. So it will be — also it will be sized similar to our PSVT programs in the sense of multi-country, multisites ranging up to 600 patients enrolled in the funnel, if you will, to deliver that 150 to 200 total AFib-RVR events.

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

Mohit Bansal: 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?

Joseph Oliveto: 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?

Mohit Bansal: Yes. So basically, like $238,000 divided by the 300 script number that you provided. So just trying to calculate it via that.

Joseph Oliveto: Okay. Well, maybe I’ll ask Lorenz or Amit to help out with that one as well. So Lorenz, maybe you could start with the ESI number.

Lorenz Muller: Sure. Yes. So ESI is one of the 3 big pharmacy benefit managers, right? It rolls up under Ascent. And so by signing a contract with them and getting coverage, that allows, as I mentioned on the call, about 1 in 4 commercially insured patients to have coverage for the drug. And that means all the plans that ESI administers a pharmacy benefit for will now have the ability to make a coverage decision and then fill the drug without all the different steps that I mentioned in the previous question from Ritu, which is an onerous prior auth process or medical exception, things that take time and requires a lot of work on the part of the physician or the pharmacy to populate. With Express Scripts, I mentioned that we think the majority of that will be what we call quality coverage.

I can’t say all of it because there’s a lot of different benefit designs under ESI and not everyone opts into the offer, but we have confidence that the majority will. And our definition of quality coverage is essentially that the — it’s not onerous to prescribe the drug and get it filled, meaning the physician’s office doesn’t have to do a ton of paperwork, in some cases, no paperwork in order for the product to be able to be filled at the pharmacy. And that 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 so they want — if they have success with the drug, which we are hearing anecdotally from patients, they are, they’ll want to go back and get a refill, and we don’t want it to disproportionately limit the amount of product that a patient can get, but we also understand that payers in a launch here might be concerned about a patient using this 30 or 50 or 80 times a year, which we’re not expecting to see.

So again, quality coverage is limit the amount of prior auth paperwork to as little as possible. And ideally, anything that’s required is adjudicated at the pharmacy and not requiring the doctor or the doctor’s office to fill a lot of paperwork and also that the quantity limits aren’t overly draconian. So we’re happy if a patient can have up to 6 or 12 fills in a year. Although in a launch year, as we’ve said, we expect most patients to use this a couple of times. On the second part of the question, by the way, I was taking note. I think, Mohit, the confusion is we had announced on the earnings call that we have around about $200,000 in net sales and that that’s coming from 600 prescriptions, not 300. So I think the math you did was a little bit off in terms of the dollars per prescription.

It is, in fact, a little bit lower than the range we’ve often quoted of $500 to $1,000, but that’s because we’re in the first quarter of launch, and we are seeing a lot more use of denial conversion or where medical exceptions aren’t going through, we do want those patients to have access to the drug. So we expect that number to increase steadily over the next few quarters to get into the range of what we’ve reported previously.

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

Tiago Fauth: I just want to talk a little bit more about the acceleration in prescription volume, right? 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? Does that quality coverage actually could increase the pace of net adds? And then I have a follow-up just in terms of the depth of prescribers and the patient journey. Question here is mostly about the ramp for the launch, right? So 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, depth of prescribing and also the utilization per patient, what are some of the levers early in the launch? I understand, but just trying to think about this the longer term.

Joseph Oliveto: 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. So these first quarter numbers are really all without any coverage pretty much or very, very little coverage, whatever you get initially out of the gate. So remember that is the first thing. We do see coverage in general and then ESI is a good early win is providing 2 things. One is obviously a little better pull-through once a script gets to the pharmacy and that paperwork, as Lorenz said explained, having to be a lot less, if any, to be able to actually see the script show up and actually get filled.

So that’s the first part. And then the subsequent kind of intangible that is just the reality these days is physicians will write if they know that there’s less hassle factor. It’s funny. I’ve been out in the field now too handfuls of times. And very consistently, you’re ending the call with how do I get it? Is it covered? Is it in Epic? That type of stuff. What pharmacy has it? And is it covered and what have I got to do? And what does my staff have to do is a real question. So it’s an intangible, but I can’t help but believe that with coverage, and we are very cognizant of not wanting to put too much burden on these offices with the idea of turning them off. A doctor has to write 2 or 3, 4 pieces of paperwork for a patient and then they don’t get it, that can frustrate them.

So we’re very sensitive to not having that happen. And getting that coverage. And at the end of the day, we think that as we get coverage and less of that paperwork has to happen, it’s going to result in more initial scripts. So it’s just in the back of the physician’s mind. So yes, to acceleration. However, remember, Express Scripts, while a big payer, it’s 1 of 3 on the commercial side. And remember, about half of our population is commercial, about half of the population is Medicare. So think of it as like half of the 25% that we reported for the total target addressable market in terms of coverage so far. So a ways to go on that front. So that was a lot on that. Lorenz, maybe you can move on to the second and third questions.

Lorenz Muller: 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 listing 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 refills.” That’s sort of a dynamic. We will also accelerate our adoption.

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

Brandon Folkes: 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.

Joseph Oliveto: 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.

Lorenz Muller: Sure. So we’ve always said that this is a patient-driven market. And we still — everything we’re seeing in the launch so far suggests that, that was a correct assessment. And so it’s really a question of timing rather than — so it’s not if, but it’s when. And what I mean by that is you don’t want to drive patients, this is in any therapeutic area into the HCP office or into a prescriber office if the prescriber is not aware of the new drug, right? That always becomes problematic. It’s one of the reasons why DTC ads are not allowed in the launch year, meaning television. So what we’re doing is to be compliant with that, which we believe, which we agree with, is we’ve done some pilots, as Joe alluded to, which are really primarily targeting tools that are already in doctors’ offices, whether they’re wallboards or whatever that is, to be able to generate some awareness amongst patients and see if we can actually raise awareness amongst patients through those tactics.

So they’re not expensive, but there are things that are very scalable. So if we invest in that and we do it for a period of 2 or 3 months and we 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 very confident that if a patient is aware of a new treatment for SVT since there’s no competition out there, they will likely go into the doctor and ask for it. And where they do ask for it, more than likely it will be granted. Then more broadly in terms of patient activation, so that was just awareness generation tactics. But in terms of actually doing kind of the customer relationship marketing, building educational resources and then capturing patients by advertising for them and then building a relationship with them and marketing to them.

So the classic direct-to-patient type tactics. We are in the process of building those capabilities, and we expect to bring them online in a time frame, whether it’s later this year or early next, where we have sufficient awareness and trial amongst cardiology that they’re not going to be surprised that a patient is coming in to ask for the drug and certainly won’t be irritated by that. So that’s kind of how we think about the staged rollout of a very important and long-term tactic that I think will drive business, which is patient activation. In terms of the second part of your question, Brandon, around what are some of the — how is the launch tracking from our view? You kind of captured the 3 broad areas. So we think about payers, we do think we’re a little bit ahead of what we were expecting with the early win from ESI.

And we — nobody asked about how we’re doing with the other big payers, but we are in active discussions and are pleased with what we’re seeing in terms of level of engagement, right? You can’t get to a contract, you can’t get to coverage if the 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, which is the big 3 PBMs as well as the Medicare payers where we’re setting ourselves up to be within the consideration set for formulary decisions in 2027. So there — I’d say we’re ahead of plan. In terms of cardiologists and HCP reception, we are hearing very positive feedback and Joe and I have seen it when we’ve been out in the field ourselves in terms of the profile of the drug.

People seem very happy with the efficacy and the safety data. It doesn’t take very long when you’re in the field as a rep or as one of us going out to get the doctor to say, “Okay, I get it.” This looks really interesting. Yes. And then you start talking about what kind of a patient and when am I going to be able to write this. I can say we’ve mentioned earlier in the pre-approval that we were targeting around 10,000 doctors. We currently have engaged with about 1/3 of those doctors, meaning a sales rep has been in there one or multiple times to actually get in and talk and make them aware of etripamil. And you heard me earlier, so that’s — think about it as around 3,000 or 4,000 doctors that have actually been engaged with a sales rep. And you heard earlier that we have around 400 writers.

So we’re seeing north of a 10% prescribing rate for the people that we’ve reached. And this early in the launch, 2 to 3 months in, we’re actually quite pleased with that metric. We expect it to obviously grow as we get more reach and as we get more frequency on these customers. But that’s an early metric that I think is a sign of, that the launch is tracking as we hoped it would. And then the patient response is the third area that’s very important. All we’ve heard at this point is anecdotal from social media listening about how patients are responding to the drug. Not many patients have gotten a prescription and actually use the drug given the nature of the episodes, but some have. And so far, that response has been overwhelmingly positive.

And so that’s a very good sign that patients are having good experience. They’re going to report that back to their doctor and then they’re going to get refills.

Brandon Folkes: Congrats on the launch progress to date.

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

Georgia Bank: 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?

Joseph Oliveto: 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.

Lorenz Muller: Fair enough. Thanks, Georgia, for the questions. So 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 very much varies in terms of the access. So it is definitely too early to be able to calculate promotional response. We can get an anecdotal feel for, wow, that doctor got one detail and they wrote a script, and we saw that a number of times, right? So that’s very promising and suggests that it’s not complicated to understand how to use this drug, and there don’t appear to be any concerns about new mechanisms or safety concerns or any of that, that would limit a doctor based on an initial encounter or two with a sales rep to be willing to write the drug and actually follow through with getting it filled.

So that feels pretty good early on. But you’re right, we will, over time, want to get doctors not only to reach more customers than the ones we’ve already reached, so go beyond the roughly 1/3 of our targets that we’ve reached and get to a higher number and then also get more depth, which would result in it being more top of mind, which means that each doctor would end up writing for more than one patient over time. In terms of sales force expansion, our strategy at launch is still valid, which we thought is we’re going to go out with a sufficiently sized sales force, our 60 reps, where we can confidently demonstrate demand, but not get ahead of coverage. So what we don’t want to do is make a number of — a larger number of physicians frustrated by the fact that they can’t get scripts filled and then decide they’re not going to write until we have broader coverage.

So we felt like that was the rightsized sales force to be able to go out with. And as we do gain coverage, this has always been the strategy, focused on commercial first, but over time, next year, we hope to get some Medicare coverage. That will be the time to consider expanding the sales force. But you also heard me say earlier that we’re also going to be thinking about ramping up patient activation. And so it’s going to have to be a responsible decision around what gets the biggest bang for the buck. So later this year, we’ll have a better sense of the promotional response for our existing promotion. In other words, how much do we pay for a rep and how many scripts does that rep generate? And we’ll also have a sense from some of the pilots about how effective patient activation is.

If we market to a patient, we identify them and market to them, will they actually go in and get a script. And we can measure all that because they’re largely digital tactics. And based on that, we’ll make a decision probably later this year or early next year around where do we put the resource, which one gets the bigger bang for the buck. So it’s going to be ROI driven in terms of how we expand the commercial effort, and it’s not just focused on the sales force. You also asked about any differences in promotional response from cardiologists versus electrophysiologists. And again, it’s too early to calculate that from data. But again, having been out in the field, Joe also alluded to the number of times he’s been out. The use case and the discussion with an EP is a little different than with a cardiologist, and we’ve trained our reps to be able to accommodate that.

But we’re not necessarily seeing any incremental resistance to prescribing and/or any overly enthusiastic prescribing differences between cards and EPs. It’s just that how they think about using the drug is a little different. A cardiologist is more likely managing a newly diagnosed patient that doesn’t want an ablation or an existing patient that is dissatisfied with existing therapies. And the EP is more thinking about how to use the drug potentially on a patient that they’re queued up and waiting for an ablation. And your last question is around — on sales force productivity and maximizing that. And again, it’s too early to calculate that, but conventional, let’s call it, wisdom or experience would suggest that when you deploy a new sales force, you need at least 3 to 6 months before they can get out to all of their customers, to get to their reach targets and also get sufficient frequency on their customers to get them on whatever adoption path that particular customer is on.

So I’d suggest that second half of this year is what we’ll have a better sense of that. And that’s also when we feel like we can start to calculate promotional response, which would drive some of the investments that I mentioned earlier in this answer.

Joseph Oliveto: 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.

Operator: 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.

Joseph Oliveto: 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.

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