Milestone Pharmaceuticals Q2 2026 Earnings Report

Milestone Pharmaceuticals EPS Results

• Actual EPS: -$0.21
• Consensus EPS: -$0.20
• Beat/Miss: Missed by -$0.02
• One Year Ago EPS: N/A

Milestone Pharmaceuticals Revenue Results

• Actual Revenue: $0.56 million
• Expected Revenue: $0.82 million
• Beat/Miss: Missed by -$258.00 thousand
• YoY Revenue Growth: N/A

Milestone Pharmaceuticals Announcement Details

• Quarter: Q2 2026
• Date: 8/12/2026
• Time: Before Market Opens
• Conference Call Date: Wednesday, August 12, 2026
• Conference Call Time: 8:30AM ET

Milestone Pharmaceuticals (NASDAQ:MIST), Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for respiratory diseases. The company’s research emphasizes both biologic and small-molecule approaches designed to improve mucociliary clearance, reduce airway inflammation and address chronic and refractory cough. Milestone’s pipeline targets key underserved conditions such as cystic fibrosis, primary ciliary dyskinesia and severe asthma.

Milestone’s lead product candidates are delivered through inhalation or systemic administration, reflecting the company’s commitment to optimizing therapeutic delivery directly to the lungs. Preclinical and early clinical studies are aimed at demonstrating safety, tolerability and proof of concept in patient populations with high unmet medical need. The company leverages strategic collaborations and research partnerships to accelerate development and expand its scientific expertise.

Founded in the United States and headquartered in San Diego, California, Milestone Pharmaceuticals operates with a management team experienced in respiratory drug development. The company continues to pursue regulatory pathways for its lead programs and is preparing for later-stage clinical trials. Through a combination of internal innovation and external partnerships, Milestone seeks to bring new treatment options to patients suffering from debilitating respiratory disorders.

Milestone Pharmaceuticals Q2 2026 Earnings Call Transcript

Key Takeaways

• Early CARDAMYST launch momentum: Second-quarter prescriptions exceeded 1,200, with more than 600 unique prescribers and over 1,000 patients receiving treatment, bringing first-half totals to more than 1,500 prescriptions, 800 prescribers, and 1,300 patients. Management said prescribing is broadening across electrophysiologists, cardiologists, and advanced practice providers, with repeat use beginning to emerge.
• Commercial coverage expanded materially: Formulary coverage increased from approximately 25% of commercially insured lives at the end of Q2 to more than 50% by early August, following wins at UnitedHealthcare and other insurers tied to major pharmacy benefit managers. The company expects broader coverage to improve patient access, prescription growth, and average selling prices by reducing copay assistance and denial conversions.
• Patient and physician marketing is set to scale: With coverage reaching a perceived critical mass, Milestone is initiating targeted digital patient activation through CARDAMYST.com, social media, search, and healthcare websites, while increasing sales-call frequency among receptive prescribers. Management believes patient requests and deeper engagement with early adopters can accelerate demand in the second half of 2026.
• AFib-RVR program advances: The pivotal Phase III RIVERA 301 trial has activated lead sites and is expected to enroll its first patients shortly, using the same 70 mg dose and repeat-dose regimen as CARDAMYST. A successful study could support a single-study supplemental NDA for a substantially larger estimated addressable population of 3 million to 4 million symptomatic AFib-RVR patients.
• Launch spending increased losses: Second-quarter selling, general and administrative expense rose to $22.6 million from $8.9 million a year earlier, contributing to a net loss of $28.6 million versus $13.0 million. Product revenue was $0.6 million for the quarter, although management said cash and short-term investments of $170.6 million should fund operations into the second half of 2027.

Presentation

[Operator]

Greetings. Welcome to the Milestone Pharmaceuticals 2Q 2026 earnings conference call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Michael Wood from LifeSci Advisors. Thank you, Michael. You may begin.

[Michael Wood, Managing Director at LifeSci Advisors]

Thank you, and good morning, everyone, and welcome to Milestone Pharmaceuticals' second 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 June 30th, 2026, and recent corporate highlights. The release can be accessed on the Investors' media section of the company's website, milestonepharma.com. Before we begin, I would 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 details 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; 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 during the Q&A session. I will now turn the call over to Joseph Oliveto. Please go ahead.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Thank you, Michael. Good morning, everyone, and thank you for joining us today to hear about our progress through the second quarter. Until this year, patients experiencing sudden attacks of paroxysmal supraventricular tachycardia, or PSVT, had no FDA-approved self-administered treatment available to them. Now, a growing population of patients in the U.S. have CARDAMYST in their homes, in their workplaces, in their pockets, or wherever it's convenient for them to have on-hand to treat their PSVT. Today, we're excited to report on our first full financial quarter since our commercial launch in mid-February. We're seeing growing evidence that physicians, patients, and payers recognize the value of CARDAMYST as a new treatment paradigm for PSVT.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

I'll start by taking you through total scripts, the number of unique prescribers and patients filling prescriptions, and we'll report these figures for the quarter, compare them to the prior quarter, and add them for the first half results. Realize that the first quarter is a partial quarter, and first half figures represent approximately four and a half months of promotion between mid-February and the end of June. We'll also provide an update on market access coverage and how it has changed since our last investor call in May. For the second quarter of 2026, ending June 30th, we continue to view the breadth of prescriber experience as one of the more important positive early indicators for the launch.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

More than 600 unique healthcare professionals wrote prescriptions for CARDAMYST in the second quarter, compared with approximately 200 in the first quarter, for a total of greater than 800 unique prescribers across the first half of the year. We recorded more than 1,200 total prescriptions in Q2, compared with approximately 300 in the first quarter, bringing the total prescriptions for the first half of 2026 to more than 1,500. More than 1,000 patients received CARDAMYST in the second quarter, compared with nearly 300 in the first quarter, for a total of more than 1,300 patients in the first half of the year. As of today, we have secured formulary coverage representing more than 50% of commercially insured lives. Most of this progress of additional coverage has come very recently, specifically in July and August.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

During the second quarter, coverage remained relatively unchanged at approximately 25% of commercially insured lives, which we reported on at our May investor call. Our recent crossing of the 50% commercially insured mark is an important achievement which will enable increased access to CARDAMYST for patients in those plans, as well as providing us with increased confidence for gaining coverage from additional plans. Lorenz will share further insights about the launch, but before turning the call over to Lorenz, I'll provide an update on the AFib-RVR program. From the start of our development of this novel compound and delivery system, our aim has been to shift appropriate acute care for tachycardias from the current treatment state, which is reactive and healthcare setting intensive, to one that is proactive and patient-empowering by enabling patients to treat themselves outside the hospital.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

We are now at an exciting intersection of both fulfilling that promise for patients with PSVT and having begun the registrational phase III stage of evaluating etripamil in the broader population of patients, those who experience atrial fibrillation with rapid ventricular rate, or AFib-RVR. We have begun our pivotal phase III trial evaluating etripamil for treatment of AFib-RVR, as announced in our last earnings release. Thanks to the efforts of the Milestone clinical team, our lead clinical sites are now active, and we expect our first patients to be enrolled shortly. We believe AFib-RVR represents a substantially larger opportunity for etripamil to help patients than it has for PSVT. Atrial fibrillation is a growing problem in the United States, estimated to impact over 10 million people. From this, we estimate an addressable population with burdensome symptomatic RVR of 3 million-4 million patients.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Somewhat like PSVT, patients with AFib-RVR experience symptomatic episodes, and currently for AFib, have limited and suboptimal self-administered treatment options. As a result, many of these episodes are managed in the emergency department using intravenous therapies or even electrical cardioversion. We are looking to leverage the strong and unique foothold that we have established in the cardiovascular space to address these current limitations. The design of our phase III AFib study, called ReVeRA-301, follows the same approach that was the basis for our successful phase III program in PSVT. Patients self-administer study medication, either etripamil or placebo in a double-blinded fashion, at home in response to their symptoms using the same 70 mg dose and repeat dose regimen that is already approved for CARDAMYST in PSVT.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Many of the operational components of the study and many of the clinical sites are the same as those that were performed and performed well in our PSVT program. We believe this continuity between the two programs lowers our executional risk and reflects the experience we, meaning our team, the clinical investigators, and our collaboration partners, have built across the etripamil program. Our regulatory approach in AFib using our phase III study is a single-study supplemental new drug application, or sNDA. This is an efficient registrational pathway to a potential label expansion, and we will provide further updates on this program as it progresses. In addition to our progress toward an indication for AFib-RVR, we are progressing towards regulatory decisions in PSVT in Europe and China. If successful, these will expand access to etripamil globally.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Our marketing application with the European Medicines Agency, or EMA, remains on track for a decision expected in the first half of 2027. For China, the engagement with the Chinese regulators is being carried by our partner, Everest Medicines. I will now turn the call over to Lorenz to cover our commercial progress in more detail.

[Lorenz Muller, Chief Commercial Officer at Milestone Pharmaceuticals]

Thank you, Joe, and good morning, everyone. Building on Joe's remarks, I will highlight what we are seeing six months into the launch and specifically how we are well-positioned to accelerate in the coming months. We are excited about the progress of our work towards securing commercial coverage for CARDAMYST, which is a critical goal that can define success in the first year of a drug launch. At the end of Q2, we had secured coverage for an estimated 25% of commercial lives, which primarily accounted for the early win we achieved at the end of Q1 with Express Scripts. In the weeks since the quarter close, we have seen a meaningful step-up in coverage.

[Lorenz Muller, Chief Commercial Officer at Milestone Pharmaceuticals]

As of last week, approximately half of commercially insured lives are now covered, driven by formulary decisions at UnitedHealthcare and several other prominent commercial insurers that use either Express Scripts or Optum Rx as their pharmacy benefit manager. It is important to see our focused and persistent market access work gain traction, and we remain optimistic about securing the last of the major PBMs and associated insurance providers, as well as pulling through additional plans who work with ESI and Optum Rx. The receptivity among payers is an important signal. We believe it tells us that they appreciate the clinical value of CARDAMYST and anticipate that demand will continue to grow.

[Lorenz Muller, Chief Commercial Officer at Milestone Pharmaceuticals]

As Joe mentioned at the top of the call, we are also very encouraged by the growing breadth of prescribers we have seen to date, and just as importantly, that electrophysiologists are strongly engaged in prescribing CARDAMYST for their patients. Recognized as the key opinion leaders in the treatment of tachycardias, these physicians represent many of the early adopters of CARDAMYST. Early experience among electrophysiologists is important because as awareness of CARDAMYST continues to grow, use and endorsement by this subspecialty will influence demand generation in general cardiology. In terms of demand generation, in Q2, we have seen steady, consistent growth in prescriptions for CARDAMYST. In addition to electrophysiologists, our sales efforts have established a broad and growing receptive base of prescribers that include clinical and interventional cardiologists, as well as advanced practice providers, such as nurse practitioners within cardiology practices.

[Lorenz Muller, Chief Commercial Officer at Milestone Pharmaceuticals]

As we move through the second half of the year, our efforts will continue to grow this base of new prescribers while simultaneously focusing on the early adopters of CARDAMYST with the goal of driving greater depth of prescribing, encouraging the healthcare providers already using CARDAMYST to prescribe it more consistently across their eligible patients. A second area of our launch strategy that we are initiating is targeted patient activation. With coverage now at approximately 50% of commercially insured lives, we believe we have reached an important tipping point where patients can have greater confidence in accessing CARDAMYST. We have also learned from market research that when patients ask their healthcare provider about CARDAMYST, there is a high likelihood that they will receive it.

[Lorenz Muller, Chief Commercial Officer at Milestone Pharmaceuticals]

With that foundation in place, we believe that now is the right time to begin building patient awareness through our enhanced cardamyst.com experience and targeted digital advertising. This investment will encourage interested patients to speak with their healthcare providers and download resources that make CARDAMYST affordable for commercially insured patients. Together, we believe that enhanced promotion to healthcare providers as a result of learnings from the first six months of launch, combined with newly initiated patient activation efforts, will support an acceleration of demand for CARDAMYST in the quarters ahead. I will now turn the call over to Amit for a review of our financials.

[Amit Hasija, CFO and EVP of Corporate Development at Milestone Pharmaceuticals]

Thank you, Lorenz. As of June 30th, 2026, we had cash, cash equivalents, and short-term investments of $170.6 million, compared with $106 million at December 31st, 2025. We expect cash, cash equivalents, and short-term investments to be sufficient to cover operating expenses and capital expenditure into the second half of 2027. Product revenue for the three months and six months ended June 30th, 2026, was $0.6 million and $0.8 million respectively. There was no product revenue recorded in the three-month or six-month periods ended June 30th, 2025. Research and development expense net of tax credits was $3.5 million for the second quarter of 2026, compared with $3.7 million for the same period in 2025.

[Amit Hasija, CFO and EVP of Corporate Development at Milestone Pharmaceuticals]

For the six months ended June 30th, 2026, research and development expense was $6.8 million, compared with $8.6 million for the same period in 2025. The decrease was a result of a decrease in outside service costs related to drug development and research. Selling, general and administrative expense was $22.6 million for the second quarter of 2026, compared with $8.9 million for the second quarter of 2025. For the six months ended June 30th, 2026, selling, general and administrative expense was $43.3 million, compared with $24.4 million for the same period in 2025. The increase was a result of additional personnel costs, professional costs, and other operational expenses related to the launch of CARDAMYST.

[Amit Hasija, CFO and EVP of Corporate Development at Milestone Pharmaceuticals]

Net loss for the second quarter of 2026 was $28.6 million or $0.21 per share, compared with a net loss of $13 million or $0.20 per share for the second quarter of 2025. For the six months ended June 30th, 2026, net loss was $54.7 million or $0.41 per share, compared with $33.7 million or $0.51 per share for the same period in 2025. For further details on our financial results, please refer to our quarterly report on Form 10-Q for the quarter ended June 30th, 2026, which was filed with the SEC this morning. I will now turn the call back over to Joe for closing remarks.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Thank you, Lorenz and Amit. Today, we've reported on numbers and metrics that we are following closely, and I'm sure we'll discuss further. Let's remember why we're here and the value of our product. I'd like to share some recent anecdotes we've received from the field about PSVT patients and their experience with CARDAMYST. This includes having received stories from patients with self-described history of, quote-unquote, multiple trips to the emergency department, who successfully converted to normal sinus rhythm on CARDAMYST and without the trip to the ED.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

We've heard recently from a medical assistant who, after she recounted the specifics of the patient's success story, which I unfortunately can't share the details, finished a note with, [she], meaning the patient, is excited, the doctor's excited, and I'm excited, and I needed to let you know. Another patient actually made a special trip back to his provider's office only to share the great success he had with CARDAMYST. These stories serve as powerful reminders of the transformational impact we're having on patients' experience with PSVT. They lift us up and reinforce our commitment to the cardiology patient community. We can't help but believe stories like these also lift healthcare providers up because they can offer an innovative option that their patients are excited about. In closing, the first half of the year has given us a solid foundation to build on.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

We have established a broad and growing receptive base of prescribers, which we believe tells us the clinical value of CARDAMYST is resonating. We have expanded commercial coverage to roughly half of commercially insured lives and fully expect to pull through more commercial coverage. Together with continuously improving refined sales and marketing strategies, our goal is to continue to accelerate growth in the second half of the year. Looking beyond the PSVT launch, we are particularly excited about initiating our phase III AFib-RVR study and enrolling the first patient soon. We will share that news as soon as it's available. That concludes our remarks, and we will now open the call for questions.

[Operator]

Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would 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. One moment please, while we poll for questions. Our first question is from Ritu Baral with TD Cowen & Company. Please proceed with your question.

[Athena Chin, Analyst at TD Cowen & Company]

Hi, guys. This is Athena Chin on for Ritu Baral. Thanks for taking the question. I wanted to get more color on your prescribing trends, especially on the 600 new or unique prescribers through Q2. What percentage of them were high-volume writers versus one-time prescribers? How are you seeing the breakdown between prescribing trends between cardiologists, electrophysiologists, and nurse practitioners kind of shifting throughout this launch? Thank you.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Hey, Athena. Thanks for the question. Just to come back to specific numbers, through Q2, we're at around 800 unique prescribers. That is a strength that leads us as a forward indicator for expected prescription growth going forward. We did report that 800 unique prescribers prescribed to about 1,300 patients over that first four and a half months through June 30th. Just doing the math, you can see a lot of those writers are, if you will, one-time writers. We see this as a strength. As we've gotten out into the field, we've probably reached about half of our targets. Recall that we have about 10,000 high-value targets on our call list. Of those targets, we also have explained that we call on the whole office, and there's about 16,000, what we call affiliate members, associated with the offices of those targets.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

A call universe of about 26,000 of which we've reached about half, let's say. Of the 10,000 targets, about half have been called on. About 800 have written so far, which we think is a good number for that high-value target list. As I had said, a fair number of them are one-timers. We've also seen promotional response that Lorenz will talk about, and I'll also ask him to talk about the diversity of writers. But he had mentioned in the call script the value of the electrophysiologist, so he'll also comment on that.

[Lorenz Muller, Chief Commercial Officer at Milestone Pharmaceuticals]

Yeah. Thanks, Athena. Regarding the mix, we're pleasantly surprised that it's a broad, not only is it a significant number of writers, but also it's a healthy mix of clinical cardiologists, interventional cardiologists, nurse practitioners and what we call APPs, but also electrophysiologists, as I alluded to on the prepared remarks. We always expected EPs to treat these patients, but we didn't expect them to write as early and as broadly because, let's face it, their job is to do ablations, right? We always expected some use, but we're seeing, I think more than we even expected, which I think is an early sign of, a good sign for the market, where we've got the thought leaders that are getting experience and then going to be advocating for it. On the promotional response, we also are obviously measuring this.

[Lorenz Muller, Chief Commercial Officer at Milestone Pharmaceuticals]

We're now six months in, so we're starting to get a small number of doctors that are getting five calls, six calls, seven calls, eight calls, 10 calls. We are pleased to see real response, meaning as you get more promotion, you do get more prescriptions. Again, that's across the board. It's not isolated to EPs or cardiologists. But I can tell you that EPs have a strong promotional response, meaning when they hear about the drug, it's a calcium channel blocker, they see these patients frequently, and they have a real use case for it. So they are prescribing it relatively early in what we typically see for cardiology launches.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Yeah. So Athena, just to put a wrap on it, what that means for us going forward is we would still expect to see continued breadth and growth of breadth of prescribers as seen by prescribers that write after one or two calls. Given the promotional response now, it directs us to go with more frequent calling where it is appropriate, and we see that there should be benefits once you get beyond five calls or six calls to actually have further writing. So it is a double-pronged approach that will start going forward where depth will be added to breadth.

[Athena Chin, Analyst at TD Cowen & Company]

Got it. Thank you.

[Operator]

Our next question is from Ted Tenthoff with Piper Sandler. Please proceed with your question.

[Ted Tenthoff, Analyst at Piper Sandler]

Great. Thank you, and congrats on the study progress. I really appreciated the patient vignettes. That is really encouraging and cool to hear, because I do think this is a really important therapy. I wanted to get a sense, it may still be a little bit early, but just any commentary you have on pricing and whether or not there is gross-to-net discounting that you are seeing. Then also, again, it still may be a little bit early, but any early indications on repeat use. I am trying to get back to sort of the real world numbers that you used for annual attack rates. So thanks for answering those.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Yeah. I will start. I will ask Amit to add any additional color on average selling prices. I will start there, though. Foundationally, this is a market that hasn't had any new development, certainly on the drug side, for decades. We consciously went into this market knowing that it is a market that has to be broken into and woken up a little bit. The thought process was the value prop would ring true across the continuum of patients, physicians, and payers. We made a bet, and we continue to believe that's the right strategy, to try to make the drug easy to get as we work through coverage.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

We are really happy to report very recent 50% coverage, but through the second quarter, which is what these numbers are on, Ted, really, while we were happy to get Express Scripts early in the quarter and eventually see that pull through, the second quarter, we really had relatively low coverage, if you think about it, right? 25% of commercially covered lives. Commercial is about half of the overall population. We are talking about a small piece of the overall population. As a result of that, our strategy was to allow for a fair amount of co-pay mitigation. When you don't have a lot of coverage, that means a lot of denial conversion, meaning that the script is basically given away and we don't make any revenues from it. That really swamps out your average selling price over that period while coverage is low.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

With Q3 now starting and we are just getting, I mean, literally, in July and even just the other day, we got more coverage. July into mid-August here, that's growing beyond 50%. As that grows, we think that amount of denial conversion and overall co-pay mitigation will start to come down over time.

[Ted Tenthoff, Analyst at Piper Sandler]

Yeah.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

It's hard to predict exactly when, but we still believe we got the right strategy. Let's make it easy to get the drug. Let's make it a good experience for doctors and patients when they get it. Not having a good experience means going through a lot of paperwork. We try to limit that until we can get coverage, and that's when we will start to see increases in average selling price kick up as we get better coverage and less denial conversion.

[Ted Tenthoff, Analyst at Piper Sandler]

That makes a lot of sense.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

You talked about also repeat use, right? If we look at just the numbers, Q1, very early, 300 scripts, 300 patients. Q2, I guess we had 1,500 scripts over 1,300 patients. So good signal that we are starting to see repeat use per patient, which is a great sign. As time goes by, we will see that more and more, right? We have seen it in our clinical trials. We expect that to happen in the real world as well.

[Ted Tenthoff, Analyst at Piper Sandler]

Great. Excellent. Thanks for all that additional color.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Thanks, Ted.

[Operator]

Our next question is from Mohit Bansal with Wells Fargo. Please proceed with your question.

[Mohit Bansal, Analyst at Wells Fargo]

Great. Thank you very much for taking my questions, and congrats on all the progress. I just wanted to understand. So a couple of questions there. So number one, I just wanted to understand the difference between commercially covered life that is 25% versus the covered lives here. Is this the step edit which is an issue, which is the difference between these two, or are there any other things? And would the covered life be same as commercial covered lives at some point? I would love to get some clarification there. The second question is, basically, so far for the 25% commercially covered lives, the kind of rebates and all, are they in the ballpark of what you were thinking before, or are there some difference there? Thank you.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Yeah. No, great questions, and I will clarify that, Mohit. It was really a simple concept. Essentially, SVT is about half of our population is under 65, and about half of our population is over 65. When that breaks down into coverage, it is actually, to be very specific, a little bit more like 45% commercial, 45% Medicare, and about 10% other, which is kind of Medicaid and government-type programs like that. So that is what I was talking about when I talked about the whole population. When you think of commercially covered lives, you think about that being about half of the overall population. So when we say we have about 25% of commercially covered lives, we are talking about 25% of just that portion of the population. Medicare and stuff like that comes starting in 2027, and we will get there.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

That is why we have always focused investors, analysts, and even prescribers to really starting with commercial, because we expect commercial coverage to come sooner than Medicare coverage would come, and that is playing out. With regard to the rebates, the short answer is yes. We think, and we have always said, that we have priced this product such that with moderate rebates, we would be able to have good coverage and have reasonable out-of-pockets for patients. At least with the initial coverage we have so far, which is now approaching 50% or now exceeded 50% of commercially covered lives, it is right in the ballpark of what we thought.

[Mohit Bansal, Analyst at Wells Fargo]

Awesome. Thank you very much. Appreciate it.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Thanks.

[Operator]

Our next question is from Tiago Fauth with Raymond James. Please proceed with your question.

[Tiago Fauth, Analyst at Raymond James]

Thanks for taking the question. Just kind of a follow-up on the commercial coverage improvements. That expanded coverage, I know we are going to see more impacts on that in Q4, but I am trying to understand how can it translate to prescription, both behavior and also net revenue per patient. Is this mostly going to convert some of the prescriptions that are already being written to commercial and you are going to get a higher net revenue per script? Or could this actually be a trigger of better access and more written prescriptions because physicians can actually get a little easier access on that? Just a follow-up on ReVeRA, because again, you are using the exact same formulation, you have an existing database, it would be an sNDA. What is the remaining risks on that AFib trial?

[Tiago Fauth, Analyst at Raymond James]

Is it going to be like the symptom endpoint, the patient identification, enrollment, trial execution? Can you just talk about some of the levers there? Thank you.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Okay. Thanks, Tiago. Three questions as I captured them there. I think the first was around with improving coverage, how does that impact scripts and revenues, essentially. It impacts both, I would say. Foundationally, I say it would have the most impact on revenues, on improved average selling prices, because as I said before, we'll just have less denial conversion associated with the products, right? Which we're doing quite extensively now. We should see with that coverage pulled through in Q3 and impacting Q4, we should start to see eventual improvements in average selling price and better gross-to-nets. You're very astute, though, to ask about impacts on scripts as well, because let's face it, doctors know that new drugs come with access hurdles.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

When I'm out in the field, the typical call closes with, Looks like a great idea, how do I get it and is it covered? They fundamentally know that that involves paperwork, and that involves the work of their office to get it through. It's a soft variable. Tiago, I can't put an exact number on it, but it's there in their minds. We believe fully that once we I don't know if this is exactly the time, but once we get to critical mass of coverage, then physicians know it's going to go through. Their patients can pick it up at their local pharmacy with a reasonable out-of-pocket and awareness of our co-pay card, bringing a reasonable out-of-pocket down to $25 is going to go quickly and it's not going to involve a lot of extra paperwork.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

That's in their minds and we fully believe that'll increase script growth once we start reaching a critical mass of coverage. Now heading over to ReVeRA, you're exactly right. We take a lot of confidence and I'll ask David if I miss anything here. We'll take a lot of confidence in the fact that we learned a lot from the SVT program and we are really using a lot of those same tactics. All the things that we really wrapped ourselves around the [etripamil] and went well, how to identify patients, how to train patients, how to capture data, what monitor to use, how to adjudicate them too. All those details that worked very well in that program are going to follow through here. AFib-RVR, though, is different. Right?

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

I would say the main risk that we've identified for investors is that this study has two main differences to the SVT study. The first one being that the secondary endpoint is pivotal to getting the approval, and that is a patient-reported outcome. We have experience with patient-reported outcomes in SVT, but they weren't as important an endpoint. Here we have to double down and make sure that, that patient-reported outcome performs well and we capture the data as if it was a primary. That's a new thing for this program. The other main difference between, I would say, AFib-RVR program and the SVT program is those patients that misdiagnose their event. In the PSVT program, that was about 20%. 80% of the people got it correct.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

They thought they were in SVT and they dosed themselves for an SVT event, and about 20% of those events were mischaracterized. They were not actually SVT, they were dosing for something else. That dilution factor will play into the AFib program, so we will have to make sure that we limit that in the AFib program. We are all over it. We believe we will do a great job there, and we have incorporated that into the powering of the study. We will be able to see that as the study goes along in a blinded manner. We will be able to adjust our tactics as we go forward. But those are the two primary differences between the AFib program and the PSVT program from a tactical standpoint.

[Tiago Fauth, Analyst at Raymond James]

Okay. Fantastic. Thanks Joe.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Thanks a lot, Tiago. Appreciate it.

[Operator]

Our next question is from Brandon Folkes with H.C. Wainwright. Please proceed with your question.

[Brandon Folkes, Analyst at H.C. Wainwright]

Hi. Thanks for taking my questions and congrats on the quarter. I just want to kind of continue on the prescribing trends. Are you seeing prescribers undertake almost their own kind of mini patient experience trial, in that they write a script, are waiting to hear back from the patient to use it more broadly, in which case we beholden to the patient having an episode? Then carrying on, what is the physician targeting or prescribing strategy in the back half of this year and into 2027? Does it remain on growing the breadth of prescribing? Then sort of at what stage of the launch do you envision focusing more on the depth of prescribing and seeing that as a significant growth driver? Thank you.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Okay. Thanks, Brandon. So, with regard to that I love how you put it, their own patient experience trial. Are they doing that in their own heads? A little bit, yes and no, I'd say. We've heard two things. We have heard and seen that is not in doctors' heads, that they're willing to prescribe very broadly to a swath of patients, and we see that across both electrophysiology and cardiology. There are early adopters who see the value and are just prescribing it. The question there is just, do they have it top of mind when they have their patients in front of them? Then, is this the right patient? Right?

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

So, we see that, but you're very astute to ask the question because it is very common in cardiology that they actually will wait for their own experience, see how the drug does for their patient, and then write refills or write additional patients. Right? So there is a very natural tendency for that. We do see that. We have heard from some doctors; they said, Let me try it on one patient or two patients, see how it goes, and then I'll write more. So we see that as upside for sure, because the drug really has performed quite well in our view, in our experience with doctors. It goes to our strategy of getting it in the hands of patients. It is not like a chronic drug where they can get their experience in the next week.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

They have to wait for an event, so that's a little bit of a dampener for timing. But we fully expect the drug to do well and that experience to shine through. Similar to those vignettes, these things are very powerful. Maybe more than a couple of sales calls, they'll remember when a patient or a nurse walks into them and said, oh, patient so-and-so did well. We think that's going to be a multiplier effect. I'm going to ask Lorenz to expand a little further on our strategy, but the bottom line is we're doing both breadth and depth right now. Again, I'll ask him to expand a little further as to why we're doing that, particularly relative to the promotional response.

[Lorenz Muller, Chief Commercial Officer at Milestone Pharmaceuticals]

Yeah. Thanks, Brandon, for the question. Early in the launch, there's always two goals, right? You want to get doctors to raise awareness first and foremost, which is a big driver early on, right? Nothing's been new in this area for 30 years, and doctors have gotten very comfortable in how they prescribe. Going in there and initially raising awareness and getting them excited about the drug, which has proven to be relatively straightforward because it's a calcium channel blocker. That early signal of breadth of prescribing, we've been very pleased with, and the fact that it's been a sustained growth. It hasn't been a bolus early on and it's flattened out.

[Lorenz Muller, Chief Commercial Officer at Milestone Pharmaceuticals]

That's a natural part of it. Because the drug isn't necessarily top of mind, now what we're doing is now that we know where our better targets are, our reps have been out there for four to six months. They know, and they've talked to, they've profiled offices. They know which ones are actively treating SVT. They know how many patients, roughly, they're treating from all their work with those practices. They can now go back and when a person has trialed, right, they've tried it on one patient. They'll now go back and start to increase frequency on those targets while continuing to identify new targets that are perhaps a little bit later adopting. Those early adopters, they're going to be focused like a laser on those to increase their volume of prescribing, meaning get that repeat use. Meaning not refills.

[Lorenz Muller, Chief Commercial Officer at Milestone Pharmaceuticals]

That's also a part of the strategy, but making them aware that there are other patients than just the first ones they prescribed for. So it's a kind of a shift from initially doing more prospecting and understanding what the nature of the territories are and where the business is, to now shifting at least some of their effort into increasing frequency to drive more use and shifting doctors from awareness to trial to usage.

[Brandon Folkes, Analyst at H.C. Wainwright]

Great. Thank you very much and congrats on the progress.

[Operator]

Once again, if you would like to ask a question, please press star one on your telephone keypad. Our next question is from Dennis Ding with Jefferies. Please proceed with your question.

[Georgia Bank, Analyst at Jefferies]

Hey, this is Georgia Bank on the line for Dennis Ding. Congrats on the quarter, and thanks for taking our questions. I had one about what you spoke about an acceleration in the second half. I guess how much of that expectation is driven by the recent improvement in coverage versus the new patient awareness initiatives? Maybe can you provide more detail on what those patient activation efforts look like and when would you expect them to begin having a measurable impact on prescription growth? Then separately on commercially insured lives in the U.S., now that you have 50%, I guess, how quickly do you expect commercial coverage to scale from here? What should we be watching over the second half of this year in terms of any incremental payer wins? Thank you.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Hey, thanks, Georgia. It's a great question, but a difficult one to answer in terms of specificity as to exactly which tactics will drive what impact on scripts. We obviously have those internally, but we view it a little bit as a gestalt, right? We're six months into this launch. We've used the first six months here essentially for prospecting the market and seeing what's working and what's not. We've saved a fair amount of dry powder for these programs, and we foundationally have a belief that we will get commercial coverage. We thought we would get it sooner than most products. It seems like we're on target for that so far. Hard to say whether it'll continue to be ahead of coverage and coverage will grow specifically by the end of the year. But we're really bullish, given our interactions on coverage, that it's going well.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

What felt good with Express Scripts and UnitedHealthcare is continuing to feel good with the others. That's the best I could say with regard to our bullishness towards coverage coming. But exactly when, it's really in their hands, not our hands. We love the value prop. I will say, and I'll ask Lorenz to expand a little bit more on the patient activation, that was gated by design for coverage. What we did not want to do is start driving patient awareness and ask patients to go into their doctors and ask about CARDAMYST if coverage wasn't approaching some critical mass. Which we feel at least 50% of commercial coverage gives us that chip to be able to go in and start that. As coverage goes, those patients going in will have a better experience.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

So maybe I'll just use that as a foundation and ask Lorenz to expand on that as well as where the improved call targeting will help out as well.

[Lorenz Muller, Chief Commercial Officer at Milestone Pharmaceuticals]

Yeah. Thanks, Georgia, for the question. As Joe said, we've always focused on gaining coverage, getting physicians aware of the drug, getting experience with it. And at the right time, we felt there was a real opportunity to get patients also aware so that they go into their office, doctors, and ask for the drug. As Joe mentioned, there's a very high grant rate when a patient, both in general, in cardiology or in other specialties too. But we've actually seen it in our market research, where if a patient asks for CARDAMYST, it's highly likely that the physician will grant that for them. So the scale of the patient activation campaign, let's be clear, what is not is DTC. We're not going to do TV ads and all that kind of thing. We don't think the market's ready for that yet.

[Lorenz Muller, Chief Commercial Officer at Milestone Pharmaceuticals]

We're doing a very targeted digital marketing campaign that involves advertising to patients where they are, whether it's social media or search or even banner advertising on things like WebMD and other resources so that we get the patient's attention there. The payoff is to go to a website where they can get more information. cardamyst.com, as you can see, has been enhanced with a whole front end as a patient campaign, and that will allow them to be educated. And then there's some things they can do. They're encouraged to opt in to us so we can market to them, so we can have a relationship with them. They're encouraged to go see their doctor and ask for CARDAMYST. There are resources they can download in terms of co-pay cards and whatnot.

[Lorenz Muller, Chief Commercial Officer at Milestone Pharmaceuticals]

The idea is to make them aware and then allow them to take an action and also build a relationship with them so that we can market to them over time with things like refill reminders or reminding them to go see their doctor, et cetera. So that is going to be a lot of energy this part, this second half of the year, to complement everything we're doing on the physician side to continue to drive top-line awareness, top-of-mind awareness of the doc, and continuing to see the broad set of patients in front of them that they can appropriately and write CARDAMYST for.

[Joseph Oliveto, President and CEO at Milestone Pharmaceuticals]

Yeah. Lastly, I'll just add on to that, Georgia. There's also— We don't talk about it much, many investors just ask about the sales force, but the sales force comes with surround sound as well on the HCP. So HCP awareness is still something we are working towards. We expect that to go up over time. This surround sound, these advertising on the sites that physicians are on, where they see educational materials, understanding that there's something new for SVT, I think, is a powerful aspect of our program. We've seen that putting that next to a sales representative actually improves the opportunity for a physician to write. So we'll continue to see that pull through in the second half as well.

[Georgia Bank, Analyst at Jefferies]

Got it. Thank you so much.

[Operator]

This now concludes our question-and-answer session. Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. Please disconnect your lines and have a wonderful day.

Participants

Executives

• Joseph Oliveto, President and CEO
• Lorenz Muller, Chief Commercial Officer
• Amit Hasija, CFO and EVP of Corporate Development

Analysts

• Michael Wood, Managing Director at LifeSci Advisors
• Athena Chin, Analyst at TD Cowen & Company
• Ted Tenthoff, Analyst at Piper Sandler
• Mohit Bansal, Analyst at Wells Fargo
• Tiago Fauth, Analyst at Raymond James
• Brandon Folkes, Analyst at H.C. Wainwright
• Georgia Bank, Analyst at Jefferies