마일스톤 파마슈티컬스(MIST) 2026년 2분기 실적발표 컨퍼런스 콜: CARDAMYST 커버리지 50% 돌파

핵심 요약

• 마일스톤 파마슈티컬스는 2월 중순 CARDAMYST 출시 이후 첫 전체 분기인 2026년 2분기 제품 매출이 60만 달러를 기록했다고 발표했습니다. 상반기 제품 매출은 총 80만 달러를 기록했습니다.
• CARDAMYST는 일부 기간만 포함되었던 1분기의 약 300건에서 증가해 2분기에 1,200건 이상의 처방을 기록했습니다. 2분기 동안 1,000명 이상의 환자가 치료를 받았으며, 600명 이상의 의료 전문가가 이를 처방했습니다.
• 유나이티드헬스케어 및 익스프레스 스크립츠나 옵텀Rx를 이용하는 다른 보험사들의 결정에 따라, 상업 보험 등재 비율은 2분기 말 상업 보험 가입자의 약 25%에서 실적 발표 시점까지 50% 이상으로 확대되었습니다.
• 2분기 판매관리비(SG&A)는 주로 CARDAMYST 출시에 따른 인건비, 전문 서비스 비용 및 운영 비용이 반영되어 전년 동기의 890만 달러에서 2,260만 달러로 증가했습니다.
• 2026년 6월 30일 기준 현금, 현금성 자산 및 단기 투자 자산은 총 1억 7,060만 달러를 기록했습니다. 경영진은 보유 유동성을 통해 2027년 하반기까지 운영 비용과 자본 지출을 충당할 수 있을 것으로 전망하고 있습니다.
• 마일스톤은 빠른 심실 박동을 동반한 심방세동(AFib-RVR) 치료제 에트리파밀의 핵심 임상 3상인 ReVeRA-301 시험을 시작했습니다. 주요 임상 기관들이 활성화되어 있으며, 경영진은 조만간 첫 환자 등록이 이루어질 것으로 예상하고 있습니다.

주요 재무 데이터

사업 및 운영 성과

첫 전체 상업화 분기 동안 CARDAMYST의 처방 활동이 확대되었습니다. 마일스톤은 일부 기간만 포함되었던 1분기의 약 300건에 비해 2분기에는 총 1,200건 이상의 처방을 기록했습니다. 상반기 처방 건수는 1,500건을 넘어섰으며, 이는 약 4.5개월간의 판촉 활동 성과입니다.

1분기의 약 300명 대비 2분기에는 1,000명 이상의 환자가 CARDAMYST를 처방받았습니다. 상반기 누적 인원은 1,300명을 넘어섰습니다. 경영진은 처방 건수와 환자 수의 차이가 재처방이 이루어지고 있음을 보여주는 초기 지표라고 밝혔습니다.

처방 의료진의 범위도 넓어졌습니다. 1분기의 약 200명 대비 2분기에는 600명 이상의 의료 전문가가 CARDAMYST를 처방하여 상반기 누적 처방 의료진 수는 총 800명을 넘어섰습니다. 처방 의료진에는 부정맥 전문의, 임상 및 중재 시술 심장 전문의, 전문 간호사(NP) 및 기타 전문 의료 제공자가 포함되었습니다.

경영진은 지금까지 많은 임상의들이 CARDAMYST를 한 번만 처방했다고 언급했습니다. 회사는 신규 처방 의료진을 지속적으로 확보하는 한편, 적격 환자에 대한 처방을 확대하기 위해 초기 도입 의료진 대상의 방문 영업(call) 빈도를 늘릴 계획입니다. 마일스톤은 약 10,000명의 주요 타깃 대상과 16,000명의 관련 의료진을 포함하는 영업 대상의 약 절반에 도달했습니다.

분기 말 이후 시장 접근성이 크게 개선되었습니다. 2분기 중 상업 보험 가입자 대상 등재 비율은 25% 수준에 머물렀으나, 유나이티드헬스케어 및 익스프레스 스크립츠, 옵텀Rx 관련 보험 플랜의 결정에 힘입어 실적 발표 시점에는 50%를 넘어섰습니다. 경영진은 등재 범위 확대로 처방 거절 전환율과 본인부담금 지원 부담이 줄어들어 시간이 지남에 따라 평균 판매 가격(ASP)과 매출 확정 실현율(gross-to-net)이 개선될 것으로 기대하고 있습니다.

마일스톤은 또한 CARDAMYST.com, 검색, 소셜 미디어 및 엄선된 디지털 광고를 통해 타깃 환자 대상의 마케팅 활동을 시작하고 있습니다. 이번 캠페인은 환자들이 의료진과 CARDAMYST에 대해 상담하고 약제비 지원 프로그램을 이용하도록 유도하기 위한 것입니다. 경영진은 이것이 TV 기반의 대소비자 직접(DTC) 광고 캠페인이 아니라는 점을 강조했습니다.

발작성 상심실성 빈맥(PSVT) 치료 외에도 마일스톤은 AFib-RVR에 대한 핵심 임상 3상 ReVeRA-301 시험에 착수했습니다. 환자들은 PSVT 치료제로 승인된 CARDAMYST와 동일한 70mg 용량 및 반복 투여 용법으로 가정에서 에트리파밀 또는 위약을 자가 투여하게 됩니다. 회사는 임상이 성공할 경우 단일 연구 기반의 적응증 추가 신청(sNDA) 절차를 추진할 계획입니다.

마일스톤은 미국 내 심방세동(AFib) 환자가 1,000만 명 이상이며, 이 중 증상이 심각한 빠른 심실 박동을 겪는 300만~400만 명의 환자가 공략 가능한 시장(addressable)일 것으로 추정하고 있습니다. 해당 수치는 회사 추정치입니다.

경영진 가이던스

경영진은 보유 현금, 현금성 자산 및 단기 투자 자산이 2027년 하반기까지 운영 비용과 자본 지출을 충당할 수 있을 것으로 전망하고 있습니다.

회사는 상업 보험 등재 확대가 3분기부터 환자 접근성과 매출 확정 실현율(gross-to-net) 성과에 영향을 미치기 시작하여 4분기에는 그 효과가 더욱 가시화될 것으로 예상하고 있습니다. 다만 그 시기와 규모는 보험사의 실행 일정 및 추가 등재 결정에 따라 달라질 수 있습니다.

ReVeRA-301의 주요 임상 기관들이 활성화되었으며, 경영진은 조만간 첫 환자 등록이 이루어질 것으로 예상하고 있습니다. PSVT 치료제 에트리파밀에 대한 마일스톤의 유럽 허가 신청은 2027년 상반기 유럽의약품청(EMA)의 승인 결정을 목표로 차질 없이 진행되고 있습니다. 중국에서의 규제당국 대응은 파트너사인 에베레스트 메디신(Everest Medicines)이 담당하고 있습니다.

위험 요소 및 주시 사항

• 2분기 동안 CARDAMYST의 상업 보험 등재 비율은 약 25%에 불과했습니다. 광범위한 처방 거절 승인 전환 및 본인부담금 경감 지원으로 인해 처방당 인식 매출이 감소했습니다.
• 추가적인 보험사의 결정은 마일스톤의 직접적인 통제 범위 밖에 있어 향후 등재 확대 속도가 불확실합니다.
• 여전히 많은 CARDAMYST 처방 의료진이 1회 처방에 그치고 있습니다. PSVT는 발작성으로 발생하므로 의사는 처방 범위를 넓히기 전에 환자가 발작을 겪고 치료하는 과정을 기다려야 할 수 있습니다.
• ReVeRA-301 임상은 경영진이 승인에 중요하다고 밝힌 환자 보고 2차 평가변수(patient-reported secondary endpoint)에 일부 의존하고 있습니다.
• 환자가 AFib-RVR 증상을 잘못 식별하는 경우 임상 3상 결과가 희석될 수 있습니다. 경영진은 이전 PSVT 프로그램에서 약 20%의 증상 오인율이 발생했다고 지적하며, 이 요소가 임상 시험의 검정력 설정 및 모니터링에 반영되어 있다고 밝혔습니다.

애널리스트 Q&A 주요 내용

경영진은 CARDAMYST의 초기 처방 의료진 기반은 넓지만 상당수의 임상의가 단 한 번만 처방했다고 밝혔습니다. 이에 따라 상업화 전략은 초기 시장 개척에서 처방 의료진의 지속적 확대와 호응도가 높은 타깃 대상의 판촉 빈도 증가를 결합하는 방향으로 전환되고 있습니다.

부정맥 전문의의 도입률은 경영진이 당초 예상했던 것보다 더 빠르고 광범위하게 나타났습니다. 회사는 이들 전문의를 영향력 있는 초기 도입자로 보고 있으며, 이들의 경험이 일반 심장 전문의 사이에서 더 넓은 처방으로 이어지는 데 기여할 수 있을 것으로 보고 있습니다.

약가 지정과 관련해 경영진은 초기 보험 등재와 관련된 리베이트 수준이 예상 범위 내에 있었다고 언급했습니다. 그러나 2분기의 낮은 보험 등재율로 인해 처방 거절 승인 전환이 자주 발생했으며, 이로 인해 매출을 발생시키지 못하고 처방이 제공되는 경우가 생겼습니다. 회사는 보험 등재가 확대됨에 따라 이러한 압박이 완화될 것으로 예상하고 있습니다.

경영진은 보험 등재 범위가 넓어지면 처방당 순매출과 전체 처방 건수 증가를 모두 뒷받침할 수 있을 것으로 믿고 있습니다. 용이해진 약국 접근성, 서류 절차 간소화, 상업 보험 가입 환자가 코페이 카드를 통해 본인 부담금을 25달러까지 줄일 수 있는 점 등이 의사들의 처방 의향을 높일 수 있습니다.

ReVeRA-301과 관련하여 경영진은 PSVT 프로그램과의 주요 실행상 차이점으로 두 가지를 꼽았습니다. 하나는 환자 보고 2차 평가변수의 중요성이며, 다른 하나는 잘못 식별된 증상 치료로 인한 결과 희석을 제한해야 한다는 점입니다. 회사는 맹검(blinded) 방식으로 증상 특성 분석을 모니터링하고 임상 진행 상황에 따라 운영 전략을 조정할 계획입니다.

실적 발표 전화회의 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

Operator

Greetings. Welcome to the Milestone Pharma 2Q '26 Earnings Conference Call. [Operator Instructions] 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

Hello. 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 30, 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. 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 20, 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

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 United States 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. 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 4.5 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 30, we continue to view the breadth of prescriber experience as one of the more important positive early indicators for the launch. More than 600 unique health care 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. And 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. 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 health care setting intensive to one that is proactive and patient empowering by enabling patients to treat themselves outside the hospital. 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 to 4 million patients.

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're 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-milligram dose and repeat dose regimen that is already approved for CARDAMYST in PSVT. 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 2 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. 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

Thank you, Joe, and good morning, everyone. Building on Joe's remarks, I will highlight what we are seeing 6 months into the launch and specifically how we are well positioned to accelerate in the coming months. We're 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 week since the quarter closed, we have seen a meaningful step-up in coverage. 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.

As Joe mentioned at the top of the call, we're also very encouraged by the growing breadth of prescribers we've 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. 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 health care 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've reached an important tipping point where patients can have greater confidence in accessing CARDAMYST. We've also learned from market research that when patients ask their health care provider about CARDAMYST, there is a high likelihood that they will receive it.

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 health care providers and download resources that make CARDAMYST affordable for commercially insured patients.

Together, we believe that enhanced promotion to health care providers as a result of learnings from the first 6 months of launch, combined with newly initiated patient activation efforts will support an acceleration of demand for CARDAMYST in the quarters ahead.

I'll now turn the call over to Amit for a review of our financials.

Amit Hasija

Thank you, Lorenz. As of June 30, 2026, we had cash, cash equivalents and short-term investments of $170.6 million compared with $106 million at December 31, 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 3 months and 6 months ended June 30, 2026, was $0.6 million and $0.8 million, respectively. There was no product revenue recorded in the 3- or 6-month periods ended June 30, 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. For the 6 months ended June 30, 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 6 months ended June 30, 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.

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 6 months ended June 30, 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 30, 2026, which was filed with the SEC this morning.

I will now turn the call back over to Joe for closing remarks.

Joseph Oliveto

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 "multiple trips to the emergency department" who successfully converted to normal sinus rhythm on CARDAMYST and without the trip to the ED. We've heard recently from a medical assistant who after she recounted the specifics of the patient success story, which I unfortunately can't share the details, finished a note with she, meaning the patient, is excited, the doctor is excited, and I'm excited, and I needed to let you know.

And another patient who 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. And we can't help but believe stories like these also lift health care 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. 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 in 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

[Operator Instructions] Our first question is from Ritu Baral with TD Cowen and Company.

질의응답

Chi Wen Chin

This is Athena Chin on for Ritu Baral. 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 onetime prescribers? And how are you seeing the breakdown between prescribing trends between cardiologists, electrophysiologists and nurse practitioners kind of shifting throughout this launch?

Joseph Oliveto

Athena, thanks for the question. And 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. And we did report that 800 unique prescribers prescribed to about 1,300 patients over that first 4.5 months through June 30. So just doing the math, you can see a lot of those writers are, if you will, onetime 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. So a call universe of about 26,000, of which we've reached about half, let's say. So 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.

And 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

Yes. Thanks, Athena. Regarding the mix, I mean, 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, 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? And so we weren't -- 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 measure this. We're now 6 months in. So we're starting to get a small number of doctors that are getting 5, 6, 7, 8, 10 calls. And we are pleased to see real response, meaning as you get more promotion, you do get more prescriptions. And again, that's across the board. It's not isolated to EPs or cardiologists. But I would -- 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

Yes. 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 1 or 2 calls. But given the promotional response, now it directs us to go with more frequent calling where it's appropriate, and we see that there should be benefits once you get beyond 5 or 6 calls to actually have further writing. So it's a double-pronged approach that will start going forward where depth will be added to breadth.

Operator

Our next question is from Ted Tenthoff with Piper Sandler.

Edward Tenthoff

Congrats on the study progress. And I really appreciated the patient vignettes. That's 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 kind of any commentary you have on pricing and whether or not there is gross-to-net discounting that you're seeing? And then also, again, still maybe a little bit early, but any early indications on repeat use? And I'm trying to kind of get back to sort of the real-world numbers that you used for annual attack rate.

Joseph Oliveto

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

So we're really happy to report very recent 50% coverage. But through the second quarter, which is what these numbers are on, Ted, really, while we're 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.

So we're 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. And 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. So that really swamps out your average selling price over that period while coverage is low.

With Q3 now starting, and we're 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. 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 and not having a good experience means going through a lot of paperwork. So we try to limit that until we can get coverage. And that's when we'll start to see increases in average selling price kick up as we get better coverage and less denial conversion.

Edward Tenthoff

That makes a lot of sense.

Joseph Oliveto

You talked about also repeat use, right? And 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're starting to see repeat use per patient, which is a great sign. And obviously, as time goes by, we'll see that more and more, right? We've seen it in our clinical trials. We expect that to happen in the real world as well.

Operator

Our next question is from Mohit Bansal with Wells Fargo.

Mohit Bansal

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 commercial covered lives that is 25% versus the covered lives here. Is this the step edit, which is an issue, which is the difference between these 2? Or are there any other things? And would the covered life be same as commercial covered lives at some point? Would love to get some clarification there.

And 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 there is some difference there?

Joseph Oliveto

Yes. No, great questions, and I'll 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's 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.

And 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're talking about 25% of just that portion of the population. Medicare and stuff like that comes starting in '27, and we'll get there. And that's why we've 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's playing out.

With regard to the rebates, the short answer is yes. We think, and we've always said, that we've priced this product such that with moderate rebates, we would be able to have good coverage and have reasonable out-of-pockets for patients. And at least with the initial coverage we have so far, which is now approaching 50% or now exceeded 50% of commercially covered lives, it's right in the ballpark of what we thought.

Operator

Our next question is from Tiago Fauth with Raymond James.

Tiago Fauth

Just kind of a follow-up on the commercial coverage improvement. So that expanded coverage, I know we're going to see more impacts on that in Q4, but I'm 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 into commercial and you're going to get a higher net revenue per script? Or could this actually be a trigger of better access and more prescriptions because physicians can actually get a little easier access on that?

And then 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. Like what is the remaining risks on that AFib trial? 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?

Joseph Oliveto

Okay. Thanks, Tiago. Three questions as I captured them there. So I think the first was around with improving coverage, how does that impact scripts and revenues essentially? And it impacts both, I would say. Foundationally, I'd say it would have the most impacts 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. So we should see with that coverage pull-through in Q3 and impact in Q4, we should start to see eventual improvements in average selling price and better gross-to-net.

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. And 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?" And they fundamentally know that, that involves paperwork. And that involves the work of their office to get it through. And it's a soft variable, Tiago. I can't put an exact number on it, but it's there in their minds.

So 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. They can -- 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. So that's in their minds, and we fully believe that will 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. So all the things that we really wrapped ourselves around the axle on 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? And I would say the main risk that we've identified for investors is that this study has 2 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. And 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. So that's a new thing for this program.

And the other main difference between, I would say, AFib-RVR program and the SVT program is those patients that misdiagnose their events. In the PSVT program, that was about 20%, 80% of the people got it correct. 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're all over it. We believe we'll do a great job there, and we've incorporated that into the powering of the study. And we'll be able to see that as the study goes along in a blinded manner. So we'll be able to adjust our tactics as we go forward. But that's the -- those are the 2 primary differences between the AFib program and the PSVT program from a tactical standpoint.

Operator

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

Brandon Folkes

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 and that they write a script are waiting to hear back from the patient to use it more broadly, in which case we're beholden to the patient having an episode? And then along -- 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? And 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?

Joseph Oliveto

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 2 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. They are early adopters who see the value and are just prescribing it. And the question there is just do they have it top of mind when they have their patients in front of them? And then is this the right patient, right? 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 1 or 2 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.

So it just -- and 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. 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.

And similarly 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, "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. And 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

Yes. Thanks, Brandon, for the question. So early in the launch, there's always 2 goals, right? You want to get doctors to -- you want to raise awareness, first and foremost, which is a big driver early on, right? Nothing has been new in this area for 30 years, and doctors have gotten very comfortable in how they prescribe. So going in there and initially raising awareness and getting the drug -- getting them excited about the drug, which has proven to be relatively straightforward because it's a calcium channel blocker. So that an 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. And that's a natural part of it.

But because the drug isn't necessarily top of mind, now what we're doing is where -- now that we know where our better targets are, our reps have been out there for 4 to 6 months. They know and they've talked to their 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 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, i.e., get that repeat use, meaning not refills, that's also a part of the strategy. But making them aware that there are other patients than just the first ones they prescribe 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.

Operator

[Operator Instructions] Our next question is from Dennis Ding with Jefferies.

Georgia Bank

This is Georgia Bank on the line for Dennis Ding. Congrats on the quarter. 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? And maybe can you provide more detail on what those patient activation efforts look like? And how -- when would you expect them to begin having a measurable impact on prescription growth?

And 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? And what should we be watching over the second half of this year in terms of any incremental payer wins?

Joseph Oliveto

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 6 months into this launch. We've used the first 6 months here essentially for prospecting the market and seeing what's working, 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 will 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. And what felt good with Express Scripts and UnitedHealthcare is continuing to feel good with the others. So 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 was 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. And as coverage goes, those patients going in will have a better experience. 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

Yes. Thanks, Georgia, for the question. So 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 but -- or in other specialties, too. But we've actually seen it in our market research where 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 is ready for that yet. 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, then 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 can -- they're encouraged to opt in to us and 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. So 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 -- the 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

Yes. And 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. And we expect that to go up over time. And 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. And 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.

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.