Milestone Pharmaceuticals Q1 2026 Earnings Call Transcript

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Provided by Quartr
May 13, 2026

Key Takeaways

  • Positive Sentiment: CARDEMYST launch is off to an early start with steady prescription growth, reaching about 600 total prescriptions by the end of April and over 400 unique HCP writers for roughly 560 patients. Management said the pace is increasing month over month, with April scripts roughly matching the prior two months combined.
  • Positive Sentiment: Express Scripts added CARDEMYST to its national commercial formulary, which management said gives the drug coverage access to about 25% of commercially insured lives. The company views this as an early validation of the product’s clinical and economic value and expects more payer wins ahead.
  • Positive Sentiment: Physician reception appears broad and encouraging, with early prescriptions coming from cardiology, electrophysiology, and advanced practice providers. Management highlighted that many scripts were written after only one or two sales interactions, which they see as a sign the value proposition is resonating.
  • Positive Sentiment: Milestone initiated its Phase III ReVeRA-301 trial in AFib with rapid ventricular rate and expects to enroll the first patient in the second half of 2026. The company said the study is built on positive Phase II data and uses a similar self-administration approach to its PSVT program.
  • Neutral Sentiment: The balance sheet is strong, with about $184 million in cash and investments as of March 31, 2026, enough to fund launch activities and the ReVeRA-301 study into the second half of 2027. First-quarter net loss was about $26.1 million, driven in part by higher commercial spending tied to the launch.
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Earnings Conference Call
Milestone Pharmaceuticals Q1 2026
00:00 / 00:00

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Operator

Ladies and gentlemen, good morning, and welcome to the Milestone Pharma First Quarter 2026 Earnings Conference Call. At this time, all participants are in listen-only mode. A brief question-and-answer session will follow the formal presentation. If anyone requires operator assistance during the conference, please signal the operator by pressing star and zero on your telephone keypad. 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
Managing Director at LifeSci Advisors

Thank you, operator. Welcome to the Milestone Pharmaceuticals First Quarter 2026 Financial Results and Business Update Conference Call. Early 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.

Michael Wood
Managing Director at LifeSci Advisors

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 20th, 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. With that, I'll turn the call over to Joseph Oliveto. Joe, please go ahead.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

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 CARDEMYST for acute episodes of paroxysmal supraventricular tachycardia, or PSVT. Today, our prepared remarks will highlight three advances or updates since our last quarterly call. First, we'll provide our thoughts on the launch of CARDEMYST. 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. Lastly, we'll provide an update on our financials from our CFO, Amit Hasija.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

Let's start with the launch. To recap, CARDEMYST, the brand name for etripamil, was approved by the FDA on December 12th 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 CARDEMYST became readily available through retail pharmacies by the end of January. We began promotion of CARDEMYST in earnest in mid-February, including the deployment of our national sales force of approximately 60 sales representatives. Launching within two months of the approval was an aggressive goal that we successfully met in Q1. Now, a little less than three months since the launch, we're excited to share the emerging themes we've observed so far.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

Cardiology healthcare providers across the board, including physicians, nurses, nurse practitioners, and physician assistants, are consistently responding positively to CARDEMYST. Seems clear to us that the HCP audience we've engaged so far quickly understands the value that CARDEMYST 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 CARDEMYST to their formularies. A great example of this is our earliest major win, Express Scripts National Preferred Formulary coverage. Express Scripts is one of the three major pharmacy benefit managers or PBMs, which when combined with the other two major PBMs, account for more than 80% of commercially covered lives in the United States.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

Perhaps most gratifying for us is the positive initial feedback we are receiving from the patient community, and specifically those patients who've received CARDEMYST. 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 texts, calls, and emails. The stories take the form of two flavors. The first being those patients who've used CARDEMYST and have had a positive experience during an event. Also, interestingly, stories from some patients who relay excitement simply from having obtained CARDEMYST 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.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

All of these patient stories are very valuable reminder of why we do what we do. I'll hand it over to Lorenz to provide some additional details on the launch.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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 CARDEMYST 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 healthcare 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 two months combined.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

Our data indicate that these prescriptions were written by over 400 unique healthcare professionals for approximately 560 unique patients. Our last key metric that we're reporting today and 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 CARDEMYST. 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 CARDEMYST.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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 CARDEMYST as an important and needed solution to their patients with PSVT. As I said, through the end of April, over 400 unique prescribers have written approximately 600 total prescriptions for CARDEMYST. We view this breadth as a strong leading indicator of the appeal of CARDEMYST 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.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

We are building a strong, receptive foundation of prescribers who, as coverage expands and their familiarity with CARDEMYST 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 one or two 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, we believe it reflects the compelling nature of the profile of CARDEMYST and its value proposition.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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 31st, we announced that Express Scripts, one of the nation's largest pharmacy benefit managers, added CARDEMYST to its commercial national formularies. I want to highlight the importance of this earlier than a predicted success. This is the first contracted formulary acceptance of CARDEMYST 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.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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 healthcare utilization, including emergency department visits and hospital admissions. The Express Scripts coverage decision means that we now have approximately one in four 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 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.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

We expect further announcements as those discussions progress. To summarize where we stand across our three 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 will now turn the call back over to Joe to update on progress in our clinical development program.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

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 with 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.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

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 healthcare setting. The study employs the same 70-milligram dose and repeat dose regimen that is already approved for CARDEMYST 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.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

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 our financial update.

Amit Hasija
Amit Hasija
CFO and EVP of Corporate Development at Milestone Pharmaceuticals

Thanks, Joe. We have a strong balance sheet, including approximately $184 million in 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 CARDEMYST launch activities and our operations into the second half of 2027, including the execution of the ReVeRA-301 study. The higher cash number was 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.

Amit Hasija
Amit Hasija
CFO and EVP of Corporate Development at Milestone Pharmaceuticals

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.

Amit Hasija
Amit Hasija
CFO and EVP of Corporate Development at Milestone Pharmaceuticals

The higher commercial expense was primarily a result of additional personnel costs, professional costs, and other operational costs related to the launch of CARDEMYST. 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'll now turn the call over to Joe for some concluding statements.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

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 CARDEMYST 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

Thank you. Ladies and gentlemen, we will now begin the question and answer session. If you would like to ask a question, please press star and one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Ladies and gentlemen, we will wait for a moment while we poll for questions. We take the first question from the line of Ritu Baral from Cowen. Please go ahead.

Ritu Baral
Ritu Baral
Managing Director at Cowen

Good morning, guys. Thanks for taking the question. I wanted to ask about the 400 unique prescribers and sort of the first Rxs and Rxs that have come in. Can you talk about the mix of prescribers at this point and how you expect that sort of mix evolution of the mix, especially as you continue your commercial targeting. 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. 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.

Ritu Baral
Ritu Baral
Managing Director at Cowen

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
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

Yeah. Great, Ritu. Great to hear your voice. Thanks for listening in on the call. Maybe I'll start a little bit, particularly with the prescriber mix and ask Lorenz to comment a little further on, you know, what that means for downstream as we're thinking about it now. 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. We've always said that, you know, 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.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

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 PCPs, really not many at all, and then just an other bucket that are not classified in our data. It seems to be playing true with how we've thought about it pre-launch 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. It's good to have that prescribing behavior because those are the folks that will be called by cardiologists asking about the drug.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

They're important to P&T committees. They're important to 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
Lorenz Muller
CCO at Milestone Pharmaceuticals

Sure. Happy to do that. Hi, Ritu. Thanks for the question. Joe's 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, so there wouldn't be as much reuse of the drug, assuming those ablations were successful. 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.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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 cardiologist in that practice or cardiologists are comfortable prescribing the drug, which we are seeing, you know, evolve relatively quickly, APPs will become more the day-to-day managers of these patients than 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, you know, roughly a third or a quarter or a third of the prescribing population. What we're seeing is early on is primary care that look more like cardiologists than true primary care.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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 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. We don't just provide free drug right out of the gate.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

We go through the process and then the pharmacist, and/or the physician in the office have to fill out, you know, the paperwork for prior auth or medical exception, which is where most of the scripts come through ahead of coverage. Only where those prior auth or medical exceptions are not granted do we then come in primarily with assistance. 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 the sign of an 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
Ritu Baral
Managing Director at Cowen

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

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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

Ritu Baral
Ritu Baral
Managing Director at Cowen

Got it. Thank you. Thanks for taking all the questions.

Operator

Thank you. We take the next question from the line of Ted Tenthoff from Piper Sandler. Please go ahead.

Ted Tenthoff
Ted Tenthoff
Managing Director at Piper Sandler

Great. Thank you, and congrats on a 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. Thank you.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

Sure. I'll handle this. Of course, if there's any further questions, David Bharucha is on the line. 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. 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.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

The ultimate value prop for etripamil 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. 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 wanna follow that in this study. 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. That's what's really the driver for this study and the patient population we'd like to see.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

We believe that the study should, is powered at 90% to deliver a 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 150-200 total events. We believe that that study should take around two 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.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

It'll be also sized similar to our PSVT programs in the sense of multi-country, multi-sites, ranging up to 600 patients enrolled in the funnel, if you will. It'll deliver that 150 to 200 total AFib RVR events.

Ted Tenthoff
Ted Tenthoff
Managing Director at Piper Sandler

That's super helpful. Thank you for all the color, Joe.

Operator

Thank you. We take the next question from the line of Mohit Bansal from Wells Fargo. Please go ahead.

Mohit Bansal
Mohit Bansal
Managing Director at Wells Fargo

Great. Thank you very much for taking my question, and congrats on all the progress. I want to dive a little bit deeper in the Express Scripts formulary decision. Can you remind us what kind of prior authorization is required to make it available for the patient? If I do the math on number of prescriptions to and then the sales you are reporting, it seems pretty high, almost $800 per script number. Is that, Lorenz, you said that you are trying to make sure that payers do see it, and you are not providing free drugs just yet. Is that the reason why the gross-to-net seems to be really good here? Thank you.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

Yeah, I think those maybe are questions for Lorenz to provide color. What I'm hearing, Mohit, is you really wanna 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, right. 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
Mohit Bansal
Managing Director at Wells Fargo

Basically, like, $238 thousand divided by the 300 script number that you provided. Just trying to calculate it via that.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

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

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

Sure. Yeah. So ESI is one of the three big pharmacy benefit managers, right? 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 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 on the previous question from Ritu, which is, you know, 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.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

With Express Scripts, I mentioned that, you know, 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. We have confidence that the majority will. Our definition of quality coverage is essentially that 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. That there is the ability for the patient to refill the drug a number of times.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

Most patients have more than one episode a year, so they want, if they have success with the drug, which we are hearing anecdotally from patients they are, they'll wanna go back and get a refill. We don't want it to disproportionately limit the amount of product that a patient can get. We also understand that payers in a launch year might be concerned about a patient using this, you know, 30 or 50 or 80 times a year, which we're not expecting to see. Again, quality coverage is, you know, 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. The quantity limits aren't overly draconian.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

You know, we're happy if a patient can have, you know, up to six or 12 fills in a year. Although in a launch year, as we've said, we expect most patients to use this, you know, a couple of times. On the second part of the question, by the way, I was taking notes. I think, Mohit, the confusion is we had announced on the earnings call that we have, you know, around about $200,000 in net sales and that that's coming from 600 prescriptions, not 300. I think the math you did was a little bit off in terms of the $ per prescription. It is, in fact, a little bit lower than the range we've often quoted of $500 to $1,000.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

That's because we're in the first quarter of launch and we are seeing a lot more use of denial conversion or, you know, where medical exceptions aren't going through. 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've reported previously.

Mohit Bansal
Mohit Bansal
Managing Director at Wells Fargo

Sounds good. Thank you very much for this. Appreciate it.

Operator

Thank you. We take the next question from the line of Tiago Fauth from Raymond James. Please go ahead.

Tiago Fauth
Tiago Fauth
Managing Director at Raymond James

Great. Thanks for taking the question. I just wanna talk a little bit more about the acceleration in prescription volume, right? You are seeing that steady pace of adds, an increase in adds. I'm curious, and again, it hasn't been that long, but Express Scripts agreement, can we expect to see some degree of acceleration relative to that? Does that quality coverage actually could increase the pace, the pace of net adds? 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? 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 one a year?

Tiago Fauth
Tiago Fauth
Managing Director at Raymond James

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. Thank you.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

Okay. Hey, 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. 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 really all without any coverage, pretty much. Or very, very little coverage, whatever you get initially out of the gate. Remember that as the first thing. We do see coverage in general, and then ESI is a good early win, is providing two things.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

One is obviously a little better pull-through, once a script gets to the pharmacy and that paperwork, as Lorenz had explained, having to be a lot less, if any, to be able to actually see the script show up and actually get filled. That's the first part. 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, you know, two 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?".

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

"Is it covered, and what do I got to do?" and what does my staff have to do is a real question. 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. You know, a doctor has to write two or three, four pieces of paperwork for a patient, and then they don't get it, that can frustrate them. We're very sensitive to not having that happen and getting that coverage. At the end of the day, we think that as we get coverage and less of that paperwork has to happen, it's gonna result in more initial scripts.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

It's just in the back of the physician's mind. Yes to acceleration. However, remember Express Scripts, while a big payer, it's one of three on the commercial side. Remember about half of our population is commercial, about half of the population is Medicare. Think of it as like half of the 25% that we reported for the total target addressable market in terms of coverage so far. A ways to go on that front. That was a lot on that. Lorenz, maybe you can move on to the second and third questions.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

Yeah, I will. I'll just add one other thing on the acceleration. You were focused a lot, Tiago, on the, you know, the coverage part of acceleration, and we certainly think broader coverage will be, for the reasons Joe mentioned, a driver of acceleration. The other one is promotional response, right? Our reps have been out there now for a couple, three months. You know, they've seen a lot of their customers only once or maybe twice. 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. That's a little bit of answering to the 2nd part of your question, which you were asking about, you know, two parts as I heard.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

One was, you know, what are the tactics or the levers where target physicians will write more than they're currently doing? You know, most of our physicians, based on the numbers we reported this morning, have written a script, although about 25% have written more than that. The second part was, you know, how are we gonna drive utilization of the patient where they fill more than one script? Both of those will happen over time, and they're related to both the physician's 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.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

Where they ask for a second script to be filled even before they have a first episode because they wanna have access to the drug. You know, 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, you know, in close proximity, so when they have that unexpected episode, they can treat it quickly. 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.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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 doc, say, "Hey, that really worked for me. Could you write me another script? I'd like two refills." That sort of a dynamic will also accelerate our adoption.

Tiago Fauth
Tiago Fauth
Managing Director at Raymond James

Got it. Perfect. Thanks so much for the context there. Appreciate it.

Operator

Thank you. We take the next question from the line of Brandon Folkes from H.C. Wainwright. Please go ahead.

Brandon Folkes
Brandon Folkes
Managing Director at H.C. Wainwright

Hi. Thanks for taking my questions, congrats on all the progress so far. You know, maybe just two for me. Yeah. Can you talk about how you're thinking about targeted DTC spend going forward here? You know, last year at your commercial day, you know, 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? You know, obviously Express Scripts coming on very early on, but yeah, just put in context how you see the launch today versus sort of how you framed it last Feb. Thank you.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

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, you know, we're trying to be very thoughtful around how to use the dollars and use them in areas that are really gonna drive the most bang for the buck. Things like targeted DTC, or what we call DTP, direct to patient, as well as even things like non-personal promotions to physicians. Everyone's aware, you know, we have about 10,000 targets. I'm pretty sure everyone's aware that we're not gonna get to all those targets. There are no-see physicians in our target call base, that lends itself to non-direct promotion or what we call non-personal promotions.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

These are ability to get the message and the information to these offices that we can't have our reps come in on, right? 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. 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.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

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's talking about.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

Sure. 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. It's really a question of timing rather than. It's not if, but it's when. 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's 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.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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. They're not expensive, but they're things that are very scalable. If we invest in that and we do it for a period of two or three 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.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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. Where they do ask for it, more than likely it'll be granted. More broadly, in terms of patient activation, so that was just awareness generation tactics. In terms of actually doing kind of the customer relationship marketing, you know, 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 DTP type tactics. We are, you know, in the process of building those capabilities, and we expect to bring them online in a timeframe, whether it's later this year or early next.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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. 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, you know, what are some of the How is the launch tracking from our view. You kind of captured the three broad areas. If we think about payers, we do think we're a little bit ahead of what we were expecting with the early win from ESI.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

We had nobody asked about, you know, 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 the level of engagement, right. You can't get to a contract, you can't get to coverage if the payers don't wanna talk to you. I can confidently say we are talking to all the major payers, both the commercial ones, which is the big three PBMs, as well as the Medicare payers, where we're setting ourselves up to be within the consideration set for formulary decisions in 2027. There I'd say we're ahead of plan.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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, yeah. Then you start talking about, you know, what kind of a patient and, and when am I gonna be able to write this? I can say, we've mentioned earlier in the pre-approval that we were targeting around 10,000 doctors.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

We're currently have engaged with about a third of those doctors, meaning our sales rep has been in there one or multiple times to actually get in and talk and make them aware of etripamil. You heard me earlier, that's, you know, think about it as around 3,000 or 4,000 doctors that have actually been engaged with a sales rep. You heard earlier, say earlier that we have around 4,400 writers. We're seeing north of a 10% prescribing rate for the people that we've reached. This early in the launch, two-three 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.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

That's an early metric that I think is a sign that the launch is tracking as we'd hoped it would. 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 used the drug, given the nature of the episodes, but some have. So far that response has been overwhelmingly positive. That's a very good sign that patients are having good experience. They're gonna report that back to their doctor. They're gonna get refills.

Brandon Folkes
Brandon Folkes
Managing Director at H.C. Wainwright

Great. Thanks. Thank you very much. Congrats on the launch progress to date.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

Thanks, Brandon.

Operator

Thank you. We take the next question from the line of Dennis Ding from Jefferies. Please go ahead.

Analyst at Jefferies

Hi. Thank you for taking our questions. 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, you know, just one or two 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, you know, hit those 10,000 docs you just spoke about? Any plans for a sales force expansion to do that? Relatedly, are you seeing differences across prescriber segments such as, you know, the EPs versus the cardios in terms of the number of interactions required to drive initial and repeat prescribing? Finally, when would you expect your sales force to reach max productivity? Thank you.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

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

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

Yeah. Fair enough. Thanks, Georgia, for the questions. In terms of the early prescriptions, yeah, 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, you know, dozens of times. It really very much varies in terms of the access. It is definitely too early to be able to calculate promotional response. You know, 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? That's very promising and suggests that it's not complicated to understand how to use this drug.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

There don't appear to be any concerns about, you know, new mechanisms or safety concerns or any of 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, you know, follow through with getting it filled. That feels pretty good early on, but you're right. We will over time, you know, want to get doctors not only to reach more customers than the ones we've already reached, so go beyond the, you know, the roughly a third 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 the each doctor would end up writing for more than one patient over time.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

In terms of sales force expansion, our strategy at launch is still valid, which we thought is we're gonna go out with a sufficiently sized sales force, our 60 reps, where we can confidently demonstrate demand but not get ahead of coverage. What we don't wanna do is make a larger number of physicians frustrated by the fact that they can't get scripts filled and then decide they're not gonna write until we have broader coverage. We felt like that was the right size sales force to be able to go out with. 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.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

You also heard me say earlier that we're also going to be thinking about ramping up patient activation, it's going to have to be a responsible decision around what gets the biggest bang for the buck. 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? We'll also have a sense from some of the pilots about how effective patient activation is. If we market to a patient, if we identify them and market to them, will they actually go in and get a script? We can measure all that because it's they're largely digital tactics.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

Based on that, we'll make a decision, you know, probably later this year or early next year around where do we put the resource, which one gets the bigger bang for the buck. It's gonna 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. 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.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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. The EP is more thinking about how to use the drug potentially on a patient that they're cued up and waiting for an ablation. Your last question is around what sales force productivity and maximizing that.

Lorenz Muller
Lorenz Muller
CCO at Milestone Pharmaceuticals

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 three to six months before they can get out to all of their customers, so 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. I'd suggest that, you know, second half of this year is where we'll have a better sense of 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
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

Yeah. I think if 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 CARDEMYST for PSVT with them not wanting to bring up atrial fibrillation, and they almost to a person do. 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. 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.

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

That's the other main difference between the two 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. It really is obvious that they're really looking forward to our development in AFib, and that gets them excited and it gets our clinical team excited.

Analyst at Jefferies

Got it. Appreciate all the color. Thank you.

Operator

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

Joseph Oliveto
Joseph Oliveto
President and CEO at Milestone Pharmaceuticals

Thank you, operator. Thank you all to the investors who called in today and those who listened in. 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 line.

Executives
    • Amit Hasija
      Amit Hasija
      CFO and EVP of Corporate Development
    • Joseph Oliveto
      Joseph Oliveto
      President and CEO
    • Lorenz Muller
      Lorenz Muller
      CCO
Analysts
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