MIST

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved a significant milestone in market access, reaching over 50% of commercially insured lives as of August, up from 25% at the end of Q2. Recorded 1,200 total prescriptions in Q2, a fourfold increase over the partial Q1, driven by a growing base of over 800 unique prescribers. Observed strong early adoption among electrophysiologists (EPs), who serve as key opinion leaders and are expected to influence broader general cardiology prescribing. Maintained a 'patient-first' access strategy by utilizing co-pay mitigation and denial conversion to ensure patients receive medication while formulary coverage is finalized. Initiated the pivotal Phase III ReVeRA-301 study for AFib-RVR, leveraging the same 70mg etripamil dose and delivery system used in the approved PSVT indication. Attributed early commercial success to the 'transformational' patient experience, citing anecdotes of patients avoiding emergency department visits through self-administration. Anticipates an acceleration in demand during the second half of 2026 as recent coverage wins at UnitedHealthcare and Optum Rx begin to pull through. Launching targeted digital patient activation efforts to encourage patient-physician dialogue, timed to coincide with the crossing of the 50% coverage threshold. Expects gradual improvement in average selling price (ASP) and gross-to-net margins as the proportion of covered scripts increases and denial conversion costs decrease. Projecting a regulatory decision from the European Medicines Agency (EMA) for PSVT in the first half of 2027. Maintains a cash runway into the second half of 2027, sufficient to fund the ongoing CARDAMYST launch and the Phase III AFib-RVR clinical program. Identified patient-reported outcomes (PROs) as a critical secondary endpoint risk in the AFib-RVR study, requiring rigorous data capture compared to the PSVT program. Acknowledged a 'dilution factor' risk in the AFib trial where patients may misdiagnose symptoms, though powering has been adjusted based on PSVT program learnings. Reported a significant increase in SG&A expenses ($22.6M vs $8.9M YoY) primarily due to personnel and operational costs associated with the CARDAMYST commercial launch. Noted that Medicare coverage for CARDAMYST is not expected to begin until 2027, making commercial insurance the primary near-term revenue driver. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management noted that while many of the 800 unique prescribers are currently 'one-time' writers, this breadth is a positive forward indicator for future growth. Internal data shows a clear promotional response, with prescribing volume increasing significantly after physicians receive 5 to 6 sales calls. Improved coverage is expected to reduce the 'paperwork hurdle' for physicians, which management believes acts as a soft variable currently dampening script growth. Higher coverage will directly improve net revenue per patient by reducing the need for the company to fully subsidize denied claims. The AFib-RVR study (ReVeRA) utilizes the same clinical sites and operational framework as the successful PSVT trials to lower execution risk. Management highlighted that AFib-RVR represents a substantially larger market opportunity, with an estimated 3 million to 4 million addressable patients in the U.S.

Milestone Pharmaceuticals Inc. (NASDAQ:MIST) shares dropped 12.60% on Wednesday after the biopharmaceutical company reported a second-quarter loss that was wider than Wall Street expected, despite continued progress with the commercial launch of CARDAMYST. For the quarter ended June 30, 2026, Milestone recorded an adjusted loss of $0.21 per share, compared with the analyst consensus forecast for a loss of $0.19 per share. Product revenue reached $559,000 during the quarter, compared with no revenue in the same period last year, following the launch of CARDAMYST for paroxysmal supraventricular tachycardia in mid-February 2026. Milestone reported growing adoption of CARDAMYST as the number of healthcare professionals prescribing the treatment expanded significantly during the quarter. “We continue to make steady progress on the launch of CARDAMYST for PSVT supported by prescription growth from a widening base of new prescribers and a meaningful recent increase in insurance coverage,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. More than 800 unique prescribers had started patients on CARDAMYST by June 30, up from approximately 200 at the end of the first quarter. More than 1,500 prescriptions had been filled for over 1,300 patients by the end of the second quarter. That compares with approximately 300 prescriptions for 300 patients at the end of the previous quarter. Commercial insurance coverage for CARDAMYST has also increased substantially as Milestone works to broaden access to the treatment. Coverage has reached approximately 50% of commercially insured lives in the U.S., following recent formulary additions from UnitedHealthcare and other major commercial insurers. That represents a significant improvement from coverage of around 25% during the second quarter and could support further prescription growth as access to CARDAMYST expands. Milestone recorded a net loss of $28.6 million for the three months ended June 30, 2026, compared with a $13.0 million loss in the corresponding period last year. Research and development expenses declined modestly to $3.5 million from $3.7 million year on year. However, selling, general and administrative expenses climbed sharply to $22.6 million from $8.9 million, primarily reflecting increased commercial expenditure associated with the CARDAMYST launch. Milestone ended the second quarter with $170.6 million in cash, cash equivalents and short-term investments. The company expects its existing financial resources to fund operating expenses into the second half of 2027 as it continues the commercial rollout of CARDAMYST. While the wider-than-expected quarterly loss weighed heavily on the shares, growing prescription volumes and expanding insurance coverage indicate that the CARDAMYST launch is continuing to gain traction. Milestone Pharmaceuticals stock price

Interested in Milestone Pharmaceuticals Inc.? Here are five stocks we like better. CARDAMYST gained early commercial momentum after its mid-February launch, with more than 1,200 second-quarter prescriptions and over 1,000 patients receiving treatment. Commercial insurance coverage expanded from about 25% to roughly 50% of covered lives after new agreements with major insurers and PBM networks. Milestone is shifting its commercial focus toward increasing repeat prescribing, activating patients through targeted digital marketing and securing additional payer coverage. Management expects broader access to improve prescription volumes and revenue per prescription. The company activated sites for its pivotal Phase III ReVeRA-301 study of etripamil in AFib-RVR, with enrollment expected shortly. Second-quarter product revenue reached $0.6 million, while the company reported a $28.6 million net loss and ended June with $170.6 million in cash and investments, expected to fund operations into the second half of 2027. Milestone Pharmaceuticals (NASDAQ:MIST) reported early commercial traction for CARDAMYST following its mid-February launch, while advancing a pivotal Phase III study of etripamil in atrial fibrillation with rapid ventricular rate, or AFib-RVR. Chief Executive Officer Joseph Oliveto said CARDAMYST represents the first FDA-approved self-administered treatment option for patients experiencing attacks of paroxysmal supraventricular tachycardia, or PSVT. The company said physicians, patients and payers are increasingly recognizing the product’s role in managing episodes outside of hospital settings. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat During the second quarter ended June 30, more than 600 unique healthcare professionals prescribed CARDAMYST, compared with approximately 200 in the partial first quarter. More than 800 unique prescribers wrote prescriptions during the first half, which represented about four and a half months of commercial promotion. More than 1,200 total CARDAMYST prescriptions were recorded in the second quarter, versus about 300 in the first quarter. First-half prescriptions exceeded 1,500. More than 1,000 patients received CARDAMYST in the second quarter, compared with nearly 300 in the first quarter. More than 1,300 patients received the product during the first half. Oliveto said the company views the breadth of the prescriber base as an important early launch indicator. In response to an analyst question, he noted that many prescribers have so far been one-time writers, based on the relationship between the number of prescribers and patients. However, he said Milestone has reached roughly half of its approximately 10,000 high-value physician targets and sees room to build both the number of prescribers and the frequency of prescribing. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be Chief Commercial Officer Lorenz Muller said the prescriber group includes electrophysiologists, clinical cardiologists, interventional cardiologists, nurse practitioners and other advanced practice providers. He said electrophysiologists have prescribed CARDAMYST earlier and more broadly than the company initially expected, adding that the subspecialty has shown a strong response to increased promotion. Market access has also improved since the end of the quarter. Coverage stood at about 25% of commercially insured lives at June 30, largely reflecting an earlier Express Scripts win. As of the week before the call, Milestone had secured formulary coverage representing approximately half of commercially insured lives, driven by decisions from UnitedHealthcare and insurers using Express Scripts or Optum Rx pharmacy benefit management services. → First Solar’s Profit Engine Faces a New Policy Test in Washington Muller said the company remains focused on securing coverage from remaining major pharmacy benefit managers and expanding access through additional health plans affiliated with Express Scripts and Optum Rx. Management said the improved coverage base supports the next phase of the CARDAMYST launch. The company plans to continue identifying new prescribers while increasing promotional frequency among early adopters and practices that are actively treating PSVT. Oliveto said increased insurance coverage should improve both prescription volume and revenue per prescription over time. During the early launch period, the company used copay assistance and denial-conversion programs to make the product accessible despite limited coverage. Those efforts reduced average selling prices, he said, but the company expects less denial conversion as payer access expands. The company also said it has begun targeted patient activation efforts, including enhancements to cardamyst.com and digital advertising. Muller said the campaign is not a broad direct-to-consumer television effort. Instead, it will use targeted advertising on social media, search platforms and health-information websites to educate patients, encourage discussions with providers and offer affordability resources for commercially insured patients. Management said patient awareness efforts were intentionally delayed until commercial coverage reached a level that would provide patients with greater confidence that they could access the drug. The company said its market research indicates that patients who ask their physicians about CARDAMYST have a high likelihood of receiving a prescription. Milestone has activated lead clinical sites for its pivotal ReVeRA-301 Phase III trial evaluating etripamil for AFib-RVR, with first patient enrollment expected shortly. The trial uses the same 70-milligram dose and repeat-dose regimen approved for CARDAMYST in PSVT. Patients will self-administer etripamil or placebo at home in a double-blind setting after experiencing symptoms. Oliveto said atrial fibrillation affects an estimated more than 10 million people in the U.S., and Milestone estimates that 3 million to 4 million patients may have burdensome symptomatic rapid ventricular rate episodes. The company is pursuing a single-study supplemental new drug application pathway for a potential label expansion. Management said the program can leverage operational components, clinical sites and experience from the company’s PSVT studies. However, Oliveto identified two key differences: a patient-reported outcome will be pivotal to the AFib-RVR program, and the company will need to limit the impact of patients incorrectly identifying their episodes before self-administering the study drug. Milestone also said its marketing application with the European Medicines Agency for PSVT remains on track for a decision in the first half of 2027. In China, regulatory engagement is being managed by partner Everest Medicines. Milestone reported second-quarter product revenue of $0.6 million, compared with no product revenue in the year-earlier period. First-half product revenue was $0.8 million. Research and development expense, net of tax credits, was $3.5 million in the second quarter, down from $3.7 million a year earlier. Selling, general and administrative expense increased to $22.6 million from $8.9 million, which the company attributed to personnel, professional and operational expenses associated with the CARDAMYST launch. Net loss was $28.6 million, or $0.21 per share, compared with a loss of $13 million, or $0.20 per share, in the second quarter of 2025. For the first six months of 2026, net loss was $54.7 million, or $0.41 per share. Cash, cash equivalents and short-term investments totaled $170.6 million at June 30, compared with $106 million at the end of 2025. Chief Financial Officer Amit Hasija said the company expects its cash resources to fund operating expenses and capital expenditures into the second half of 2027. Milestone Pharmaceuticals, 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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Milestone Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Over 50% of commercially insured lives in the U.S., representing a recent and significant increase, now have coverage for CARDAMYST® (etripamil) nasal spray Phase 3 registrational trial of etripamil for atrial fibrillation with rapid ventricular rate (AFib-RVR) first clinical sites activated, advancing Milestone’s potential, second cardiovascular indication $170.6 million in cash, cash equivalents and short-term investments as of June 30, 2026, provides runway into H2 2027 Company to host investor call and webcast at 8:30am ET today MONTREAL and CHARLOTTE, N.C., Aug. 12, 2026 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced financial results for the second quarter ended June 30, 2026, and provided corporate and regulatory updates. “We continue to make steady progress on the launch of CARDAMYST for PSVT supported by prescription growth from a widening base of new prescribers and a meaningful recent increase in insurance coverage. We are confident that this increased coverage paired with optimized sales and marketing strategies positions us to drive acceleration of CARDAMYST prescriptions moving forward,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “Separately, we have activated several sites in our Phase 3 ReVeRA-301 trial in AFib-RVR and look forward to enrolling the first patient. AFib-RVR is one of the most common heart arrhythmias, affecting millions of Americans. The trial is evaluating the same self-administered regimen already approved in PSVT, giving us a clear path toward extending etripamil to a larger, adjacent patient population.” Launch Progress for CARDAMYST CARDAMYST® (etripamil) nasal spray was launched for paroxysmal supraventricular tachycardia (PSVT) in mid-February 2026. More than 800 unique prescribers have started patients on CARDAMYST through June 30, compared to approximately 200 at the end of Q1. More than 1,500 scripts for CARDAMYST have been filled for more than 1,300 patients with PSVT through June 30, 2026, compared to approximately 300 scripts for 300 patients at the end of Q1. Commercial lives covered remained relatively unchanged through Q2 at approximately 25%; however, covered lives have significantly grown to approximately 50% to date as a result of recently reported formulary coverage for CARDAMYST from UnitedHealthcare and several other prominent commercial insurers. CARDAMYST has been nominated for the 2026 Prix Galien USA Awards for “Best Pharmaceutical Product.” Regulatory and Clinical UpdatesRegulatory review of the marketing authorization application for etripamil for PSVT in Europe remains on track for a decision from the European Medicines Agency (EMA) in the first half of 2027. The New Drug Application for etripamil for PSVT in China is currently under review by China’s National Medical Products Administration (NMPA). Our partner, Everest Medicines, is responsible for engagement with the NMPA for the program. Two new articles have been published in the peer-reviewed Journal of the American College of Cardiology: Advances, supporting the efficacy, safety and emerging role of CARDAMYST for the management of PSVT. Paroxysmal Supraventricular Tachycardia Treatment: Evaluating the Evidence for Established and Newly Approved Options, a summarization of the current acute PSVT treatment landscape, that includes the limitations of existing management approaches and the emerging role of etripamil nasal spray as an acute, self-administered option for outside of the healthcare setting. Minimal Blood Pressure Effects of Intranasal Etripamil for Paroxysmal Supraventricular Tachycardia, an analysis showing that intranasal etripamil has minimal blood pressure effects, with hypotension and syncope occurring rarely across more than 1,600 clinical trial participants. Additionally, “The Impact of Paroxysmal Supraventricular Tachycardia on Patients’ Daily Life and Quality of Life Between Episodes,” an analysis which demonstrates the substantial burden between PSVT episodes, PSVT patients’ quality of life and full participation in daily activities, will be presented at the upcoming European Society of Cardiology (ESC) Congress, August 28-31, 2026. Phase 3 registrational trial in atrial fibrillation with rapid ventricular rate (AFib-RVR) is now open and enrolling patients. The ReVeRA-301 Phase 3 registrational trial evaluating self-administered etripamil as a potential treatment for patients with AFib-RVR is now open, with several sites activated and evaluating patients for enrollment. Previously announced plans to enroll the first patient in the second half of 2026 remain on track. The Company intends to follow the supplemental New Drug Application (sNDA) regulatory approval pathway and expects to leverage the initial PSVT indication and its safety database along with the results from the planned Phase 3 study in AFib-RVR. Second Quarter 2026 Financial Results As of June 30, 2026, Milestone had cash, cash equivalents, and short-term investments of $170.6 million, compared to $106.0 million as of December 31, 2025. The Company currently expects its cash, cash equivalents and short-term investments to be sufficient to cover operating expenses and capital expenditure into the second half of 2027. Product revenues were $0.6 during the three months ended June 30, 2026. There was no product revenue during the three months ended June 30, 2025. For the six months ended June 30, 2026, product revenues were $0.8 million. There was no product revenue during the six months ended June 30, 2025. Research and development expense for the three months ended June 30, 2026, was $3.5 million, compared with $3.7 million for the prior year period. For the six 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 for the three months ended June 30, 2026, was $22.6 million, compared with $8.9 million for the prior year period. For the six 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. For the three months ended June 30, 2026, net loss was $28.6 million or $0.21 per share, compared to a net loss of $13.0 million or $0.20 per share for the prior year period. For the six 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 the Company’s financials, refer to the Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the U.S. Securities and Exchange Commission (SEC) today. Conference Call and Webcast Details CallMe™: Participants can use guest dial-in numbers above and be answered by an operator OR click the CallMe™ link for instant telephone access to the event. The CallMe™ link will be made active 15 minutes prior to scheduled start time. A replay of the audio webcast of the call will be available under the “Investors and Media” section of Milestone’s corporate website, www.milestonepharma.com. About CARDAMYST CARDAMYST® (etripamil) nasal spray is approved by the U.S. Food and Drug Administration (FDA) for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. It is a novel calcium channel blocker nasal spray designed as a self-administered rapid response therapy for patients, thereby bypassing the need for immediate medical oversight. The product is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT. Currently, etripamil is in Phase 2 development for treatment of PSVT in pediatric patients and Phase 3 development for control of acute atrial fibrillation with rapid ventricular rate (AFib-RVR) in adults. For more information, please visit CARDAMYST.com. IndicationCARDAMYST is indicated for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. IMPORTANT SAFETY INFORMATION FOR CARDAMYST (etripamil) What is CARDAMYST?CARDAMYST is a prescription medicine used to help restore normal sinus heart rhythm in adults who have symptoms of sudden episodes of fast heartbeat called paroxysmal supraventricular tachycardia (PSVT). It is not known if CARDAMYST is safe and effective in children. Do not use CARDAMYST if you: are allergic to CARDAMYST or any of its ingredients. See the Patient Information for a complete list of ingredients in CARDAMYST. have limitations in activities due to heart failure (moderate to severe heart failure). have Wolff-Parkinson-White (WPW) syndrome, Lown-Ganong-Levine syndrome, or an abnormal heart rhythm pattern called pre-excitation (delta wave) on an electrocardiogram (ECG). have sick sinus syndrome without a permanent pacemaker. have second degree or higher atrioventricular (AV) block. Before using CARDAMYST, tell your healthcare provider about all of your medical conditions, including if you: have a history of fainting. have low blood pressure. are pregnant or plan to become pregnant. It is not known if CARDAMYST will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if CARDAMYST passes into your breast milk. You should stop breastfeeding for 12 hours after treatment with CARDAMYST. During this time, pump and throw away your breast milk. Talk to your healthcare provider about the best way to feed your baby after using CARDAMYST. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of CARDAMYST? CARDAMYST may cause serious side effects, including: Fainting due to CARDAMYST effects on blood pressure, heart rate, and electrical activity of the heart. CARDAMYST may cause dizziness and fainting, especially in people with a history of fainting and certain heart problems, or people with a history of fainting during an episode of PSVT. Use CARDAMYST while sitting in a safe area where you will not fall if you become dizzy or lightheaded. Lie down if you feel dizzy or lightheaded after using CARDAMYST. If fainting occurs after using CARDAMYST, caregivers should place you on your back and seek medical help. The most common side effects of CARDAMYST include: These are not all of the possible side effects for CARDAMYST. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please see the full Prescribing Information  https://milestonepharma.com/etripamilprescribinginformation.pdf for CARDAMYST. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is an emerging commercial-stage biopharmaceutical company advancing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST® (etripamil) nasal spray, a novel calcium channel blocker, which is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults. Etripamil is also in Phase 3 development for the control of symptomatic episodic attacks associated with AFib-RVR. https://milestonepharma.com/ Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “continue,” “could,” “demonstrate,” “designed,” “develop,” “estimate,” “expect,” “may,” “pending,” “plan,” “potential,” “progress,” “will,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: the commercialization and adoption of CARDAMYST; the timing and outcomes of future interactions with U.S. and foreign regulatory bodies, including the FDA, EMA and NMPA; the expected timing of initiation, completion, and results and data of Milestone’s ongoing and planned clinical studies, including the Phase 3 study in AFib-RVR; Milestone’s anticipated cash runway; and other statements not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to whether Milestone’s future interactions with the EMA will have satisfactory outcomes; whether and when, if at all, Milestone’s MMA for etripamil will be approved by the EMA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of Milestone’s clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs and conflicts, and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone’s capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone’s filings with the SEC, including in its annual report on Form 10-K for the year ended December 31, 2025, under the caption “Risk Factors,” as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.Investor RelationsKevin Gardner, [email protected] Media RelationsRebecca Novak, [email protected]

Image source: The Motley Fool. May 13, 2026, 8:30 a.m. ET President and Chief Executive Officer — Joseph Oliveto Chief Commercial Officer — Lorenz Muller Chief Financial Officer — Amit Hasija Need a quote from a Motley Fool analyst? Email [email protected] Joseph Oliveto: Thank you, Michael. Good morning, everyone, and thank you for joining us today. This is an exciting day as it represents our first analyst call reporting on our first ever quarter or, more accurately, partial quarter of sales since the commercial launch of CARDAMYST for acute episodes of paroxysmal supraventricular tachycardia or PSVT. Today, our prepared remarks will highlight 3 advances or updates since our last quarterly call. First, we'll provide our thoughts on the launch of CARDAMYST. Second, we'll discuss the initiation of our Phase III pivotal trial for etripamil for patients with atrial fibrillation and rapid ventricular rate or AFib-RVR. And lastly, we'll provide an update on our financials from our CFO, Amit Hasija. Let's start with the launch. To recap, CARDAMYST, the brand name for etripamil, was approved by the FDA on December 12 as the first and only rapid-acting self-administered prescription therapy for acute PSVT episodes in adults. Following approval, we immediately mobilized our launch plan. We quickly engaged our distribution channels such that CARDAMYST became readily available through retail pharmacies by the end of January. We then began promotion of CARDAMYST in earnest in mid-February, including the deployment of our national sales force of approximately 60 sales representatives. Launching within 2 months of the approval was an aggressive goal that we successfully met in Q1. Now a little less than 3 months since the launch, we're excited to share the emerging themes we've observed so far. Cardiology health care providers across the board, including physicians, nurses, nurse practitioners and physicians' assistants are consistently responding positively to CARDAMYST. It seems clear to us that the HCP audience we've engaged so far quickly understands the value that CARDAMYST brings to the patients with SVT due to its safety profile and ease of effective self-administration. Insurers continue to collaborate with us on pathways to coverage with the goal of adding CARDAMYST to their formularies. A great example of this is our earliest major win, Express Scripts National Formulary coverage. Express Scripts is one of the 3 major pharmacy benefit managers, or PBMs, which when combined with the other 2 major PBMs account for more than 80% of commercially covered lives in the United States. Perhaps most gratifying for us is the positive initial feedback we are receiving from the patient community and specifically those patients who received CARDAMYST. We gain these insights of patient experiences through our ongoing patient engagement activities, our social media monitoring and through physicians and nurses feedback, much of which is in the form of unsolicited text, calls and e-mails. The stories take the form of 2 flavors. The first being those patients who've used CARDAMYST and have had a positive experience during an event, but also interestingly, stories from some patients who relay excitement simply from having obtained CARDAMYST from their pharmacy and not even having used it yet. These patients describe having an increased sense of preparedness and security for when their next event will occur. All of these patient stories are a very valuable reminder of why we do what we do. So I'll hand it over to Lorenz to provide some additional details on the launch. Lorenz Muller: Thank you, Joe, and thank you to everyone joining us this morning. Building on Joe's overview, I will provide more color on our commercial rollout and sales progress of CARDAMYST in the first part of the year. Given that it's so early in the launch, I'll break total scripts out by month, which demonstrates steady progress month-over-month. Moving forward, we plan to report total prescriptions, unique health care practitioner writers and unique patients as quarterly figures. Through the end of April, we've captured approximately 600 total prescriptions. Specifically, February generated approximately 100 prescriptions and March was around 200, totaling approximately 300 prescriptions in our first partial quarter. In April, we're reporting around 300 scripts, or as many as the previous 2 months combined. Our data indicate that these prescriptions were written by over 400 unique health care professionals for approximately 560 unique patients. Our last key metric that we are reporting today and we will continue to report quarterly is lives covered by commercial insurance. With our early Express Scripts win announced at the end of March, we conservatively estimate that 25% of all commercially insured patients have quality coverage for CARDAMYST. Now for some perspective on what these numbers mean and why they're important at this early stage. In terms of prescription volume, while it's too early to forecast trends definitively, we are pleased to see data showing steady month-over-month growth. As Joe mentioned, prescriber reception has been very positive, which we see as a validation of the core value proposition for CARDAMYST. With both a well-established calcium channel blocker mechanism and a safety profile supported by robust clinical data, we believe that these first scripts written by our target providers tell us that prescribers see CARDAMYST as an important and needed solution for their patients with PSVT. As I said, through the end of April, over 400 unique prescribers have written approximately 600 total prescriptions for CARDAMYST. We view this breadth as a strong leading indicator of the appeal of CARDAMYST among providers. When a new therapy like this is adopted across a relatively wide physician base from the onset rather than just a narrow group of early adopters, we believe it signals that the value is clearly resonating broadly. Thus, we are building a strong, receptive foundation of prescribers who, as coverage expands and their familiarity with CARDAMYST increases, should increase their prescribing depth over time. I will add that many of these prescriptions are coming from physicians who have met with one of our sales representatives only a few times. This is important as we believe in pharmaceutical launches, early trial after 1 or 2 interactions is a positive signal about the strength of the clinical story and a physician's interest in the product. This is something our commercial teams specifically aspire to from the onset, and we believe it reflects the compelling nature of the profile of CARDAMYST and its value proposition. As our reps build frequency and deepen their relationships through repeat visits, we have every expectation that this will be a driver of growing prescription patterns. Now to the third metric, coverage. On March 31, we announced that Express Scripts, one of the nation's largest pharmacy benefit managers, added CARDAMYST to its commercial national formularies. I want to highlight the importance of this earlier than predicted success. This is the first contracted formulary acceptance of CARDAMYST by a major payer. In the landscape of commercial drug launches, getting a major PBM formulary placement within the first quarter of a launch is a significant achievement. We see this as clear validation of the clinical and economic value to payers, particularly in terms of our clinical data, illustrating the potential of this drug to reduce health care utilization, including emergency department visits and hospital admissions. The Express Scripts coverage decision means that we now have approximately 1 in 4 commercially insured lives covered. We believe most of that coverage is quality coverage, meaning patients are more likely to be approved at the point of sale rather than navigating an overly onerous prior authorization process and we will be able to refill a prescription multiple times to treat subsequent episodes of PSVT. We are actively negotiating with other major PBMs and health plans. And while I won't get ahead of any specific decisions, we are committed to continuing to expand contracted coverage, and we expect further announcements as those discussions progress. So to summarize where we stand across our 3 key metrics, the breadth of new prescribers and early physician acceptance gives us confidence that we are gaining traction. We are building momentum, and we will continue to plan for an acceleration in prescription volume as our launch progresses. These measurements of growth will be driven by increased promotional frequency with our target physicians, continued pull-through from our first major coverage win and additional anticipated positive coverage decisions. I'll now turn the call back over to Joe to update on progress in our clinical development program. Joseph Oliveto: Thank you, Lorenz. I'll turn now to the next major advancement for milestone and for etripamil. Namely that we have initiated our Phase III trial for atrial fibrillation with rapid ventricular rate or AFib-RVR named ReVeRa-301. This ReVeRa Phase III registration trial is based firmly on the successful performance of etripamil in our AFib Phase II study. In that trial, patients on etripamil demonstrated a statistically significant and clinically meaningful reduction in their ventricular rate compared to placebo and also showed symptomatic improvement. The design of our Phase III AFib study, ReVeRa, uses the same approach of patient self-administration of drug and operational study conduct as our successful Phase III trials in PSVT. Specifically, the Phase III AFib ReVeRa study is a double-blind, placebo-controlled, event-driven trial in which the patient will self-administer the drug outside of the health care setting. The study employs the same 70-milligram dose and repeat dose regimen that is already approved for CARDAMYST for SVT and many of the operational conduct components are the same as those that were used in the SVT program. Regarding status, we are labeling clinical study drug. We have begun contracting with key clinical research sites with whom we've had successful experience from our PSVT trials and have completed contracting with several. We're actively recruiting additional trial sites in several geographic regions with a focus on the U.S. and the trial has been posted on clinicaltrials.gov. We expect to enroll our first patient into this trial in the second half of this year and look forward to providing further updates as the ReVeRa-301 study advances this year. I will now turn the call over to Amit for a financial update. Amit Hasija: Thanks, Joe. We have a strong balance sheet, including approximately $184 million in cash, cash equivalents and short-term investments as of March 31, 2026. This compares with $106 million at December 31, 2025. We believe our cash balance provides sufficient runway to support both ongoing CARDAMYST launch activities and our operations into the second half of 2027, including the execution of the ReVeRa-301 study. The higher cash number is primarily the result of $75 million cash payment we received in January in connection with our royalty purchase agreement with RTW, as well as approximately $19 million in net proceeds from ATM sales and Series A warrant exercises that took place during Q1. Our operating cash burn during Q1 was approximately $23.7 million. Product revenues in the first quarter of 2026 were $0.2 million. R&D expense net of tax credits was $3.3 million in the first quarter of 2026 compared to $5 million in the first quarter of 2025. The decrease compared with the prior year was primarily due to a decrease in the outside service costs related to drug development and research. G&A expense was $4.8 million in the first quarter of 2026 compared to $5.2 million in the first quarter of 2025. The decrease was primarily due to lower professional costs, partially offset by an increase in personnel costs. Commercial expense was $15.8 million in the first quarter of 2026 compared to $10.4 million in the first quarter of 2025. The higher commercial expense was primarily a result of additional personnel costs, professional costs and other operational costs related to the launch of CARDAMYST. Net loss for the first quarter of 2026 was approximately $26.1 million or $0.20 per share compared to $20.8 million or $0.31 per share in the first quarter of 2025. I will now turn the call over to Joe for some concluding statements. Joseph Oliveto: Thank you, Amit. As we reflect on the quarter, we are proud of the early execution of our launch and the progress we are making in establishing CARDAMYST as a novel treatment for PSVT. While we're still in the early stages, the initial indicators we are seeing give us confidence in the opportunities ahead with the PSVT launch and with our AFib-RVR Phase III clinical development program. Our focus remains clear: driving disciplined commercial launch execution, including expanding payer access, advancing our clinical development program and managing our resources responsibly. We believe these priorities position us well to continue our momentum over the course of 2026 and beyond. Thank you again to our team and our shareholders for your continued support. That concludes our remarks, and we will now open the call to questions. Operator: [Operator Instructions] We take the first question from the line of Ritu Baral from Cowen. Ritu Baral: I wanted to ask about the 400 unique prescribers and sort of the first Rxs, NRxs that have come in. Can you talk about the mix of prescribers at this point and how you expect that sort of evolution of the mix, especially as you continue your commercial targeting? And how do you think that, that will sort of reflect downstream on the percentage of patients -- I'm sorry, the mix of patients that you end up getting? And then according to our calculations, while you have mentioned that you're giving away free drug, it doesn't look like you've given away that much free drug. Can you talk about sort of the receptivity of that program, and has sort of bridging programs been offered and will that continue to be a part of the 2026 effort? Joseph Oliveto: Yes. Great, Ritu. Great to hear your voice. Thanks for listening in on the call. And maybe I'll start a little bit, particularly with the prescriber mix and ask Lorenz to comment a little further on what that means for downstream as we're thinking about it now. And then also Lorenz to give a little bit more color on how much free drug we're giving away and how we think about that going forward. So we've always said that this is primarily driven by clinical cardiologists. That's where the majority of these patients live in terms of their management. We always thought that EPs, electrophysiologists, could be a bigger writer in the first year, primarily because we don't have or are not expecting a lot of refills in the first year. So that was our guidance before launch. And I would say we're largely seeing that. So far, we've seen approximately 50% of the scripts to date written by cardiology and about 25% written by electrophysiology. The other 25% is really a combination of nurse practitioners, physicians' assistants, a few PCPs, really not many at all and just an other bucket that are not classified in our data. So it seems to be playing through with how we've thought about it prelaunch with the idea that while electrophysiologists are writing only 25%. Currently, that's a big number relative to where they'll be over the long haul, and they're influential, as you might be aware. So it's good to have that prescribing behavior because those are the folks that will be called by cardiologists asking about the drug. They're important to P&T committees, they're important guidelines, all those types of things. Lorenz, maybe if you want to comment a little further on how you see downstream going and then move over to the free drug program. Lorenz Muller: Sure. Happy to do that. Ritu, thanks for the question. So Joe is exactly right in that we expected the majority of early scripts to come from cardiology and maybe favor electrophysiology somewhat as the thought leaders. Over time, we would expect to continue to see the majority of our prescriptions coming from cardiology, clinical and interventional cardiology. Electrophysiology will continue to use it, but their use case is more focused on bridging patients to an ablation. And so there wouldn't be as much reuse of the drug, assuming those ablations were successful. So I think over time, we will see 2 dynamics. One is the percentage of cardiology scripts that is written by clinical cardiologists and interventionalists will increase relative to total, including EPs. And I do think the second dynamic over time is we will start to see more APPs, so nurse practitioners and physicians' assistants. As practices get comfortable that the cardiologists in that practice or cardiologists are comfortable prescribing the drug, which we are seeing evolve relatively quickly, APPs will become more the day-to-day managers of these patients and the prescribers. I also think, finally, over time, so measured in years, not months, I do think primary care will start to adopt more, although they only represent roughly 1/3 or 1/4 or 1/3 of the prescribing population. What we're seeing is early on is primary care that look more like cardiologists than true primary care. And I do think over time, primary care will also start to write more because they're seeing some of the younger patients where they don't have -- they only have -- the only form of cardiovascular disease those younger patients have is PSVT. To your second question on free drug quantities, our goal in the launch has always been to ensure that when a script comes in, that the payer is notified that there's demand there because that helps us ultimately convince payers that there is demand and therefore, that they want to cover the drug and make themselves -- avail themselves of those rebates. So we don't just provide free drug right out of the gate. We go through the process and then the pharmacist and/or the physician, the office have to fill out the paperwork for prior auths or medical exception, which is where most of the scripts come through ahead of coverage. And only where those prior auths or medical exceptions are not granted, do we then come in primarily with assistance. So I would say I was pleased to see that we are week-over-week seeing growth in the number of scripts that are actually filled. And that is in part a sign of expanded coverage, meaning the ESI coverage decision win, but also somewhat our ability to now convert patients, meaning at the end of the chain, if they don't pass medical exception, we are there to catch that patient and allow them to use the drug. Ritu Baral: So this is more sort of like true bridging rather than like a sampling effort. Is that correct? Lorenz Muller: Yes, I think that's accurate, Ritu, yes. Operator: We take the next question from the line of Ted Tenthoff from Piper Sandler. Edward Tenthoff: Congrats on the nice first quarter launch. Lorenz, always appreciate all the detail and color that you provide. My question has to do with the ReVeRa-301 and just a sense of -- I know you're just starting and just kicking it off, but walk us through a little bit more in terms of the patients that you're enrolling and maybe what our expectations should be in terms of how long it might take to enroll the study? Joseph Oliveto: Sure. I'll handle this. Of course, if there's any further questions, David Bharucha is on the line. So very importantly, and just a reminder for the audience is atrial fibrillation is a huge market. Current estimates about 10 million patients with atrial fibrillation in the U.S. alone and growing. Expectations are that this number will increase in the short term here. And very important to realize that we are looking for patients that have AFib are characterized with AFib and importantly, are characterized with AFib and events of rapid ventricular rate. These are events above 100 beats per minute and commonly last for some time and are very importantly, symptomatic to the patient. The ultimate value prop for CARDAMYST, Ted, is really to help resolve that elevated rate, bring it down towards a more normal rate, doesn't have to get all the way to normal and reduce symptoms. And by doing that, we should enable the patient to manage these episodes at home and not have to go to the emergency department for most commonly IV calcium channel blockers like IV diltiazem. That is the value prop. We want to follow that in this study. So very importantly, we're looking for patients that have a history of AFib with rapid ventricular rate, ideally more elevated rates and very importantly, symptomatic rates. So that's what's really the driver for this study in the patient population we'd like to see. We believe that the study should -- well, it is powered at 90% to deliver 0.05 based on really the second endpoint, which is symptomatic improvement. We believe that powering it that way should deliver a successful results with a total size of somewhere in the range of 150 to 200 total events. And we believe that, that study should take around 2 years from start from our first patient enrolled to data. That's our current estimate. There's a lot of variables in there, but it's driven primarily off of our experience with our PSVT program, our experience with our Phase II program in AFib and trying to triangulate around what we saw in both of those programs both with the AFib experience in the emergency department, but also operationally the PSVT program in the outpatient setting. So it will be -- also it will be sized similar to our PSVT programs in the sense of multi-country, multisites ranging up to 600 patients enrolled in the funnel, if you will, to deliver that 150 to 200 total AFib-RVR events. Operator: We take the next question from the line of Mohit Bansal from Wells Fargo. Mohit Bansal: Congrats on all the progress. I want to dive a little bit deeper in the Express Script formulary decision. Can you remind us what kind of prior auth is required to make it available for the patient? And then if I do the math on like number of prescriptions and then the sales you are reporting, it seems like pretty high, almost $800 per script number. So is that, Lorenz, like you said, that you are trying to make sure that payers do see it and you are not providing free drug just yet. Is that the reason why the gross to net seems to be really good here? Joseph Oliveto: Yes. I think those maybe are questions for Lorenz to provide color. What I'm hearing, Mohit, is you really want to know about ESI coverage and what that looks like in terms of how quality is it and what's the prior auth process was the first question. And then the second question, let me just make sure I got it correctly. Are you calculating something like $800 per script? Is that what I heard? Mohit Bansal: Yes. So basically, like $238,000 divided by the 300 script number that you provided. So just trying to calculate it via that. Joseph Oliveto: Okay. Well, maybe I'll ask Lorenz or Amit to help out with that one as well. So Lorenz, maybe you could start with the ESI number. Lorenz Muller: Sure. Yes. So ESI is one of the 3 big pharmacy benefit managers, right? It rolls up under Ascent. And so by signing a contract with them and getting coverage, that allows, as I mentioned on the call, about 1 in 4 commercially insured patients to have coverage for the drug. And that means all the plans that ESI administers a pharmacy benefit for will now have the ability to make a coverage decision and then fill the drug without all the different steps that I mentioned in the previous question from Ritu, which is an onerous prior auth process or medical exception, things that take time and requires a lot of work on the part of the physician or the pharmacy to populate. With Express Scripts, I mentioned that we think the majority of that will be what we call quality coverage. I can't say all of it because there's a lot of different benefit designs under ESI and not everyone opts into the offer, but we have confidence that the majority will. And our definition of quality coverage is essentially that the -- it's not onerous to prescribe the drug and get it filled, meaning the physician's office doesn't have to do a ton of paperwork, in some cases, no paperwork in order for the product to be able to be filled at the pharmacy. And that there is the ability for the patient to refill the drug a number of times. Most patients have more than one episode a year. And so they want -- if they have success with the drug, which we are hearing anecdotally from patients, they are, they'll want to go back and get a refill, and we don't want it to disproportionately limit the amount of product that a patient can get, but we also understand that payers in a launch here might be concerned about a patient using this 30 or 50 or 80 times a year, which we're not expecting to see. So again, quality coverage is limit the amount of prior auth paperwork to as little as possible. And ideally, anything that's required is adjudicated at the pharmacy and not requiring the doctor or the doctor's office to fill a lot of paperwork and also that the quantity limits aren't overly draconian. So we're happy if a patient can have up to 6 or 12 fills in a year. Although in a launch year, as we've said, we expect most patients to use this a couple of times. On the second part of the question, by the way, I was taking note. I think, Mohit, the confusion is we had announced on the earnings call that we have around about $200,000 in net sales and that's coming from 600 prescriptions, not 300. So I think the math you did was a little bit off in terms of the dollars per prescription. It is, in fact, a little bit lower than the range we've often quoted of $500 to $1,000, but that's because we're in the first quarter of launch, and we are seeing a lot more use of denial conversion or where medical exceptions aren't going through, we do want those patients to have access to the drug. So we expect that number to increase steadily over the next few quarters to get into the range of what we've reported previously. Operator: We take the next question from the line of Tiago Fauth from Raymond James. Tiago Fauth: I just want to talk a little bit more about the acceleration in prescription volume, right? So you are seeing that steady pace of adds -- an increase in adds. I'm curious, and again, it hasn't been that long, but the Express Script agreement, can we expect to see some degree of acceleration relative to that? Does that quality coverage actually could increase the pace of net adds? And then I have a follow-up just in terms of the depth of prescribers and the patient journey. Question here is mostly about the ramp for the launch, right? So what are some of the key levers that will lead a physician to prescribe to more patients and for a patient to actually utilize this more than once a year. I know there's probably a cap there. But again, depth of prescribing and also the utilization per patient, what are some of the levers early in the launch? I understand, but just trying to think about this the longer term. Joseph Oliveto: Okay. So Tiago, great for jumping on here and for the questions. Again, I'll start, Lorenz. I don't know if I caught all those questions at the end. I might have to ask Tiago to come back to a few of them. But certainly, ESI -- and remember, Tiago, we got that right at the end of the quarter, so right at the start of April. So these first quarter numbers are really all without any coverage pretty much or very, very little coverage, whatever you get initially out of the gate. So remember that is the first thing. We do see coverage in general and then ESI is a good early win is providing 2 things. One is obviously a little better pull-through once a script gets to the pharmacy and that paperwork, as Lorenz said explained, having to be a lot less, if any, to be able to actually see the script show up and actually get filled. So that's the first part. And then the subsequent kind of intangible that is just the reality these days is physicians will write if they know that there's less hassle factor. It's funny. I've been out in the field now too handfuls of times. And very consistently, you're ending the call with how do I get it? Is it covered? Is it in Epic? That type of stuff. What pharmacy has it? And is it covered and what have I got to do? And what does my staff have to do is a real question. So it's an intangible, but I can't help but believe that with coverage, and we are very cognizant of not wanting to put too much burden on these offices with the idea of turning them off. A doctor has to write 2 or 3, 4 pieces of paperwork for a patient and then they don't get it, that can frustrate them. So we're very sensitive to not having that happen. And getting that coverage. And at the end of the day, we think that as we get coverage and less of that paperwork has to happen, it's going to result in more initial scripts. So it's just in the back of the physician's mind. So yes, to acceleration. However, remember, Express Scripts, while a big payer, it's 1 of 3 on the commercial side. And remember, about half of our population is commercial, about half of the population is Medicare. So think of it as like half of the 25% that we reported for the total target addressable market in terms of coverage so far. So a ways to go on that front. So that was a lot on that. Lorenz, maybe you can move on to the second and third questions. Lorenz Muller: Yes, I will. And I'll just add one other thing on the acceleration. You were focused a lot, Tiago, on the coverage part of acceleration. And we certainly think broader coverage will be for the reasons Joe mentioned, a driver of acceleration. But the other one is promotional response, right? Our reps have been out there now for a couple, three months. They've seen a lot of their customers only once or maybe twice. And as they get more frequency on those customers and as they reach more of the customers in the rather large territories that they have, we do expect that to result in more prescription writing. And that's a little bit of answering to the second part of your question, which you were asking about 2 parts, as I heard. One was what are the tactics or the levers where target physicians will write more than they're currently doing. Most of our physicians based on the numbers we reported this morning, have written a script, although about 25% have written more than that. And then the second part was how are we going to drive utilization of the patient where they fill more than one script. And both of those will happen over time. And they're related to both the physicians' awareness and willingness to trial, which we're seeing, but then translating the willingness to trial to usage where they use it on more patients and where patients actually come back after they've had a successfully treated episode. or where they ask for a second script to be filled even before they have a first episode because they want to have access to the drug. So with the payers being willing to give patients, say, more than one dose at a time, we do believe patients will go in and fill a second or a third script in order to be able to have the drug on them, in the office, at home, in close proximity. So when they have that unexpected episode, they can treat it quickly. So I think all of that, the answer is time and effort for us to continue to drive promotional response, getting in front of HCPs, prescribers and making sure they're aware and trialing in appropriate patients. And then we do think over time, as patients have a successful experience with the drug, we've seen this already in some of the anecdotal social media listing we've been doing. They'll come back to the docs say, "Hey, that really works for me. Could you write me another script? I'd like to refills." That's sort of a dynamic. We will also accelerate our adoption. Operator: We take the next question from the line of Brandon Folkes from H.C. Wainwright. Brandon Folkes: Congrats on all the progress so far. Maybe just 2 for me. Can you talk about how you're thinking about targeted DTC spend going forward here? And then last year at your Commercial Day, you provided a lot of really insightful detail on how you envisioned the launch. Can you just talk about if the launch is tracking sort of within all those expectations? Anything there that you see different today? Obviously, Express Scripts coming on very early on. But yes, just put in context how you see the launch today versus sort of how you framed it last Feb. Joseph Oliveto: Sure. Again, I think I'll just provide a high level. And then, Lorenz, these are really questions for your insights. I would say with regard to targeted DTC spend, hopefully, what came across in our plans before we got the approval, Brandon, was we're trying to be very thoughtful around how to use the dollars and use them in areas that are really going to drive the most bang for the buck. And things like targeted DTC or what we call DTP, direct-to-patient as well as even things like nonpersonal promotions to physicians. Everyone is aware, we have about 10,000 targets. I'm pretty sure everyone is aware that we're not going to get to all those targets. There are no C physicians in our target call base. And that lends itself to nondirect promotion or what we call nonpersonal promotion. So these are ability to get the message and the information to these offices that we can't have our reps come in on, right? And it takes a little longer to get to those offices. But the thought is behind both of these tactics, if you will, is let's make sure we have enough coverage and enough general awareness through the more routine routes of our sales representatives and working through the coverage system before we really start driving patients into the office. So it's always been very tailored that way, and we still expect that to happen. We are, though, having pilots in those areas such that when we are ready to turn on the spigot, if you will, and open up spends on those areas, we know where and how to spend it. So that's the general philosophy of how we're approaching these things. But Lorenz, maybe you can provide a little bit more color specifically to the DTC spends that Brandon is talking about. Lorenz Muller: Sure. So we've always said that this is a patient-driven market. And we still -- everything we're seeing in the launch so far suggests that, that was a correct assessment. And so it's really a question of timing rather than -- so it's not if, but it's when. And what I mean by that is you don't want to drive patients, this is in any therapeutic area into the HCP office or into a prescriber office if the prescriber is not aware of the new drug, right? That always becomes problematic. It's one of the reasons why DTC ads are not allowed in the launch year, meaning television. So what we're doing is to be compliant with that, which we believe, which we agree with, is we've done some pilots, as Joe alluded to, which are really primarily targeting tools that are already in doctors' offices, whether they're wallboards or whatever that is, to be able to generate some awareness amongst patients and see if we can actually raise awareness amongst patients through those tactics. So they're not expensive, but there are things that are very scalable. So if we invest in that and we do it for a period of 2 or 3 months and we see a positive ROI, then we'll know we can do more of that later this year or starting next year to drive patient awareness because we're very confident that if a patient is aware of a new treatment for SVT since there's no competition out there, they will likely go into the doctor and ask for it. And where they do ask for it, more than likely it will be granted. Then more broadly in terms of patient activation, so that was just awareness generation tactics. But in terms of actually doing kind of the customer relationship marketing, building educational resources and then capturing patients by advertising for them and then building a relationship with them and marketing to them. So the classic direct-to-patient type tactics. We are in the process of building those capabilities, and we expect to bring them online in a time frame, whether it's later this year or early next, where we have sufficient awareness and trial amongst cardiology that they're not going to be surprised that a patient is coming in to ask for the drug and certainly won't be irritated by that. So that's kind of how we think about the staged rollout of a very important and long-term tactic that I think will drive business, which is patient activation. In terms of the second part of your question, Brandon, around what are some of the -- how is the launch tracking from our view? You kind of captured the 3 broad areas. So we think about payers, we do think we're a little bit ahead of what we were expecting with the early win from ESI. And we -- nobody asked about how we're doing with the other big payers, but we are in active discussions and are pleased with what we're seeing in terms of level of engagement, right? You can't get to a contract, you can't get to coverage if the payers don't want to talk to you. And I can confidently say we are talking to all the major payers, both the commercial ones, which is the big 3 PBMs as well as the Medicare payers where we're setting ourselves up to be within the consideration set for formulary decisions in 2027. So there -- I'd say we're ahead of plan. In terms of cardiologists and HCP reception, we are hearing very positive feedback and Joe and I have seen it when we've been out in the field ourselves in terms of the profile of the drug. People seem very happy with the efficacy and the safety data. It doesn't take very long when you're in the field as a rep or as one of us going out to get the doctor to say, "Okay, I get it." This looks really interesting. Yes. And then you start talking about what kind of a patient and when am I going to be able to write this. I can say we've mentioned earlier in the pre-approval that we were targeting around 10,000 doctors. We currently have engaged with about 1/3 of those doctors, meaning a sales rep has been in there one or multiple times to actually get in and talk and make them aware of etripamil. And you heard me earlier, so that's -- think about it as around 3,000 or 4,000 doctors that have actually been engaged with a sales rep. And you heard earlier that we have around 400 writers. So we're seeing north of a 10% prescribing rate for the people that we've reached. And this early in the launch, 2 to 3 months in, we're actually quite pleased with that metric. We expect it to obviously grow as we get more reach and as we get more frequency on these customers. But that's an early metric that I think is a sign of, that the launch is tracking as we hoped it would. And then the patient response is the third area that's very important. All we've heard at this point is anecdotal from social media listening about how patients are responding to the drug. Not many patients have gotten a prescription and actually use the drug given the nature of the episodes, but some have. And so far, that response has been overwhelmingly positive. And so that's a very good sign that patients are having good experience. They're going to report that back to their doctor and then they're going to get refills. Brandon Folkes: Congrats on the launch progress to date. Operator: We take the next question from the line of Dennis Ding from Jefferies. Georgia Bank: This is Georgia on the line for Dennis Ding. A quick question on the commercial strategy and launch. You mentioned many of the early prescriptions are coming from just 1 or 2 rep interactions. Can you provide more detail on just how many touch points you're seeing on average today and how you expect that to evolve as the launch matures to hit those 10,000 docs you just spoke about? And any plans for a sales force expansion to do that? And then relatedly, are you seeing differences across prescriber segments such as the EPs versus the cardios in terms of the number of interactions required to drive initial and repeat prescribing? And then finally, when would you expect your sales force to reach max productivity? Joseph Oliveto: Okay. Yes. I think some of these, Georgia, will be a little tough just given how early we are, especially when we want to talk about repeats. Really, we're just in the initial stages there. But Lorenz, a host of good questions for you to speculate on, I would say, some of these things. Lorenz Muller: Fair enough. Thanks, Georgia, for the questions. So in terms of the early prescriptions, yes, you're correct. We know many of our customers have seen a sales rep once or twice, although a number of them have seen them dozens of times. It really very much varies in terms of the access. So it is definitely too early to be able to calculate promotional response. We can get an anecdotal feel for, wow, that doctor got one detail and they wrote a script, and we saw that a number of times, right? So that's very promising and suggests that it's not complicated to understand how to use this drug, and there don't appear to be any concerns about new mechanisms or safety concerns or any of that, that would limit a doctor based on an initial encounter or two with a sales rep to be willing to write the drug and actually follow through with getting it filled. So that feels pretty good early on. But you're right, we will, over time, want to get doctors not only to reach more customers than the ones we've already reached, so go beyond the roughly 1/3 of our targets that we've reached and get to a higher number and then also get more depth, which would result in it being more top of mind, which means that each doctor would end up writing for more than one patient over time. In terms of sales force expansion, our strategy at launch is still valid, which we thought is we're going to go out with a sufficiently sized sales force, our 60 reps, where we can confidently demonstrate demand, but not get ahead of coverage. So what we don't want to do is make a number of -- a larger number of physicians frustrated by the fact that they can't get scripts filled and then decide they're not going to write until we have broader coverage. So we felt like that was the rightsized sales force to be able to go out with. And as we do gain coverage, this has always been the strategy, focused on commercial first, but over time, next year, we hope to get some Medicare coverage. That will be the time to consider expanding the sales force. But you also heard me say earlier that we're also going to be thinking about ramping up patient activation. And so it's going to have to be a responsible decision around what gets the biggest bang for the buck. So later this year, we'll have a better sense of the promotional response for our existing promotion. In other words, how much do we pay for a rep and how many scripts does that rep generate? And we'll also have a sense from some of the pilots about how effective patient activation is. If we market to a patient, we identify them and market to them, will they actually go in and get a script. And we can measure all that because they're largely digital tactics. And based on that, we'll make a decision probably later this year or early next year around where do we put the resource, which one gets the bigger bang for the buck. So it's going to be ROI driven in terms of how we expand the commercial effort, and it's not just focused on the sales force. You also asked about any differences in promotional response from cardiologists versus electrophysiologists. And again, it's too early to calculate that from data. But again, having been out in the field, Joe also alluded to the number of times he's been out. The use case and the discussion with an EP is a little different than with a cardiologist, and we've trained our reps to be able to accommodate that. But we're not necessarily seeing any incremental resistance to prescribing and/or any overly enthusiastic prescribing differences between cards and EPs. It's just that how they think about using the drug is a little different. A cardiologist is more likely managing a newly diagnosed patient that doesn't want an ablation or an existing patient that is dissatisfied with existing therapies. And the EP is more thinking about how to use the drug potentially on a patient that they're queued up and waiting for an ablation. And your last question is around -- on sales force productivity and maximizing that. And again, it's too early to calculate that, but conventional, let's call it, wisdom or experience would suggest that when you deploy a new sales force, you need at least 3 to 6 months before they can get out to all of their customers, to get to their reach targets and also get sufficient frequency on their customers to get them on whatever adoption path that particular customer is on. So I'd suggest that second half of this year is what we'll have a better sense of that. And that's also when we feel like we can start to calculate promotional response, which would drive some of the investments that I mentioned earlier in this answer. Joseph Oliveto: I think there's one thing to add, Georgia, is the difference, at least from my experience being in the field now, it's hard to get through a discussion with an electrophysiologist about CARDAMYST for PSVT with them not wanting to bring up atrial fibrillation and they, almost to a person, do. And we know that. We know that it's driven largely by the fact that their ablations in atrial fibrillation are not nearly as successful as they are in SVT. And it provides a nice bridge for us then to have that discussion with them with our medical team. We refer them over to the medical side of the house and the clinical side of the house to be able to engage them around what we're doing on the development and the Phase III program for AFib. So that's the other main difference between the 2 groups, cardiology and atrial fibrillation. We want to be super compliant and make sure we drive the message home that this drug is for PSVT. It's approved there. There's a high medical need there. To Lorenz's point, we do talk about the right patients. Maybe it's that patient getting a bridge to an ablation or that patient who's trying to decide on their ablation. That's the discussion. But it really is obvious that they're really looking forward to our development in AFib and that gets them excited and gets our clinical team excited. Operator: Ladies and gentlemen, as there are no further questions from the participants, I would now hand the conference over to the management for their closing comments. Joseph Oliveto: Thank you, operator, and thank you all to the investors who called in today and those who listened in. And I appreciate all your interest in Milestone and look forward to updating you as the launch progresses. Have a great day. Operator: Thank you. Ladies and gentlemen, the conference of Milestone Pharma has now concluded. Thank you for your participation. You may now disconnect your lines. Before you buy stock in Milestone Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Milestone Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Milestone (MIST) Q1 2026 Earnings Transcript was originally published by The Motley Fool

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Successful commercial launch of Cardamis for acute PSVT, with positive reception from healthcare providers and patients. Express Scripts National Formulary Coverage achieved, providing access to approximately 25% of commercially insured patients. Initiation of Phase III trial for atripamil in AFib-RVR, building on successful Phase II results. Strong financial position with $184 million in cash and equivalents, providing runway into the second half of 2027. Steady month-over-month growth in prescriptions, with 600 total prescriptions by the end of April. Net loss of $26.1 million for Q1 2026, an increase from $20.8 million in Q1 2025. Product revenues were only $0.2 million in the first quarter, indicating early-stage challenges in revenue generation. High commercial expenses of $15.8 million due to launch activities, impacting overall financial performance. Limited coverage beyond Express Scripts, with ongoing negotiations needed to expand payer access. Initial prescription volume is still low, with only 400 unique healthcare professionals writing prescriptions. Warning! GuruFocus has detected 5 Warning Signs with MIST. Is MIST fairly valued? Test your thesis with our free DCF calculator. Q: Can you discuss the mix of prescribers for Cardamis and how you expect this to evolve, especially with your commercial targeting efforts? Also, how is the free drug program being received? A: Joseph Oliveto, CEO: The majority of prescriptions are from clinical cardiologists, with electrophysiologists writing about 25%. Nurse practitioners and physician's assistants make up the rest. The free drug program is more about bridging rather than sampling, ensuring patients can access the drug if prior authorizations are not granted. Lorenz Muller, CCO, added that as practices become more comfortable, nurse practitioners and physician's assistants will likely manage more prescriptions. Q: Regarding the Rivera 301 trial for atrial fibrillation, can you provide more details on patient enrollment and expected timelines? A: Joseph Oliveto, CEO: The trial targets patients with atrial fibrillation and rapid ventricular rate. We expect to enroll 150-200 total events, with the study taking around two years from the first patient enrolled to data collection. The trial is based on our successful Phase II study and will involve multi-country sites. Q: Can you explain the impact of the Express Scripts formulary decision on prescription volume and the gross-to-net ratio? A: Lorenz Muller, CCO: Express Scripts coverage allows for easier prescription filling without onerous prior authorization processes. This should improve prescription volume. The gross-to-net ratio is expected to improve as coverage expands and fewer prescriptions require denial conversion. Q: What are the key levers for increasing prescription volume and patient utilization of Cardamis? A: Joseph Oliveto, CEO: Coverage expansion and promotional response are key. As reps increase frequency with healthcare providers, we expect more prescriptions. Patients are likely to refill prescriptions if they have a positive experience, and as coverage improves, we anticipate more patients will use the drug multiple times. Q: How is the launch tracking compared to your initial expectations, and what are your plans for direct-to-consumer (DTC) spending? A: Lorenz Muller, CCO: The launch is tracking well, with early payer wins and positive feedback from cardiologists. We are conducting pilots for targeted DTC spending to ensure effective use of resources. The focus is on building awareness among healthcare providers before ramping up patient-directed efforts. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management successfully executed an aggressive launch timeline, making CARDAMYST available through retail channels within two months of FDA approval. Early prescriber data shows broad adoption across over 400 unique health care professionals, signaling that the value proposition resonates beyond a narrow group of early adopters. The company secured a major early win with Express Scripts National Formulary coverage, which management views as validation of the drug's clinical and economic value to payers. Initial patient feedback highlights a dual benefit: successful acute episode management and an increased sense of security for patients simply by having the medication on hand. Prescribing patterns are currently split between clinical cardiologists (50%) and electrophysiologists (25%), aligning with pre-launch expectations for initial adoption. Management attributes early traction to the drug's well-established calcium channel blocker mechanism and a safety profile that supports effective self-administration outside of clinical settings. The company expects an acceleration in prescription volume driven by increased promotional frequency, pull-through from the Express Scripts win, and anticipated additional coverage decisions. The Phase III ReVeRa-301 trial for AFib-RVR is expected to enroll its first patient in the second half of 2026, with a projected two-year timeline to data. Management plans to transition reporting to quarterly figures for total prescriptions, unique prescribers, and unique patients to provide a clearer view of adoption trends. Future commercial investments will be ROI-driven, with potential sales force expansion and increased patient activation efforts evaluated in late 2026 or early 2027. Current cash reserves of approximately $184 million are projected to provide a sufficient operational runway into the second half of 2027. The company received a $75 million cash payment in January 2026 related to a royalty purchase agreement with RTW, significantly strengthening the balance sheet. Commercial expenses increased to $15.8 million in Q1 2026, reflecting the personnel and operational costs associated with the national launch of CARDAMYST. Management clarified that early revenue figures reflect a high volume of 'denial conversions' and bridging programs to ensure patient access while payer coverage is still being established. The 60-person sales force has currently engaged approximately one-third of the 10,000 target physicians, representing significant remaining reach potential. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management expects the percentage of clinical cardiology scripts to increase over time, while electrophysiologists will likely focus on bridging patients to ablation. The free drug program is designed as a 'true bridging' effort to ensure demand is visible to payers rather than a simple sampling program. The study is powered at 90% to detect symptomatic improvement and will require approximately 150 to 200 total AFib-RVR events. The trial utilizes the same 70-milligram dose and self-administration regimen as the approved PSVT indication to streamline operational conduct. The Express Scripts win provides 'quality coverage,' meaning minimal prior authorization paperwork and the ability for patients to refill prescriptions multiple times. Management is actively negotiating with the other two major PBMs and expects further coverage announcements as discussions progress. The company is currently running low-cost digital pilots to test patient activation tactics before committing to larger spends. Full-scale patient marketing will likely launch in late 2026 or early 2027 once physician awareness and payer coverage reach sufficient levels.

Interested in Milestone Pharmaceuticals Inc.? Here are five stocks we like better. CARDEMYST launch is underway: Milestone said first-quarter 2026 marked the start of commercial sales for its newly approved PSVT treatment, with about 600 prescriptions written through the end of April and steady month-over-month growth. Payer coverage is improving: CARDEMYST was added to Express Scripts’ commercial formularies on March 31, which Milestone says gives it access to an estimated 25% of commercially insured patients and should help reduce prior-authorization friction. Pipeline and balance sheet remain strong: The company began its Phase 3 ReVeRA-301 trial in AFib with rapid ventricular rate and ended March with about $184 million in cash, which it says should fund operations into the second half of 2027. Milestone Pharmaceuticals (NASDAQ:MIST) said its first quarter of 2026 marked the beginning of commercial sales for CARDEMYST, its newly approved treatment for acute episodes of paroxysmal supraventricular tachycardia, or PSVT, while the company also moved ahead with a Phase 3 program in atrial fibrillation with rapid ventricular rate. President and Chief Executive Officer Joseph Oliveto called the period the company’s “first-ever quarter, or more accurately, partial quarter of sales” following the commercial launch of CARDEMYST, the brand name for etripamil. The FDA approved CARDEMYST on Dec. 12 as the first rapid-acting, self-administered prescription therapy for acute PSVT episodes in adults, according to the company. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? Oliveto said Milestone made the product available through retail pharmacies by the end of January and began promotion in earnest in mid-February, including deployment of a national sales force of about 60 representatives. Chief Commercial Officer Lorenz Muller said Milestone recorded approximately 600 total prescriptions for CARDEMYST through the end of April. That included about 100 prescriptions in February, around 200 in March and approximately 300 in April. → MercadoLibre Boldly Invests in Growth: Discount Deepens Muller said the February and March totals represented about 300 prescriptions in the company’s first partial quarter of launch, while April alone matched the total from the prior two months combined. He said those prescriptions were written by more than 400 unique healthcare professionals for about 560 unique patients. “While it’s too early to forecast trends definitively, we are pleased to see data showing steady month-over-month growth,” Muller said. → MP Materials Is Quietly Building a Rare Earth Powerhouse Management said early prescriber adoption has been broad rather than concentrated among a narrow set of early adopters. In response to an analyst question, Oliveto said about 50% of prescriptions to date had been written by cardiology, about 25% by electrophysiology and the remainder by nurse practitioners, physician assistants, a small number of primary care physicians and other categories not classified in the company’s data. Muller said Milestone expects clinical and interventional cardiologists to account for a larger share of prescriptions over time. Electrophysiologists may be more likely to use CARDEMYST as a bridge to ablation, he said, while advanced practice providers could become more involved in day-to-day patient management as cardiology practices gain comfort with the drug. Milestone highlighted the March 31 addition of CARDEMYST to Express Scripts’ commercial national formularies as an early coverage milestone. Muller said the decision gives the product coverage for an estimated 25% of commercially insured patients. He described the coverage as largely “quality coverage,” meaning patients are more likely to be approved at the point of sale and face less onerous prior authorization requirements. Muller said Milestone is negotiating with other major pharmacy benefit managers and health plans and expects further announcements as discussions progress. Oliveto said coverage could help both with prescription pull-through at pharmacies and physician willingness to prescribe, because clinicians are sensitive to the administrative burden of prior authorizations and medical exceptions. During the question-and-answer session, Muller said the company does not provide free drug “right out of the gate.” Instead, it seeks to ensure that payers see demand for the product, with assistance used primarily when prior authorization or medical exception requests are not granted. He agreed with an analyst’s characterization that the approach is more of a bridging program than a sampling effort. Oliveto said cardiology healthcare providers, including physicians, nurses, nurse practitioners and physician assistants, have responded positively to CARDEMYST. He said providers appear to understand the value of the therapy based on its safety profile and self-administration. Milestone also said it has received positive initial feedback from patients, including some who have used CARDEMYST during an episode and others who reported feeling more prepared simply by having obtained the drug. The company said these insights came from patient engagement, social media monitoring and unsolicited feedback relayed through physicians and nurses. Muller said many prescriptions have come from physicians after only one or two sales representative interactions, which management views as a positive early signal. He said the company has engaged with about one-third of its roughly 10,000 target physicians and is seeing a prescribing rate north of 10% among reached physicians. Milestone also said it has initiated ReVeRA-301, a Phase 3 pivotal trial of etripamil in patients with atrial fibrillation and rapid ventricular rate, or AFib RVR. Oliveto said the trial is based on a Phase 2 study in which patients receiving etripamil demonstrated a statistically significant and clinically meaningful reduction in ventricular rate compared with placebo and showed symptomatic improvement. ReVeRA-301 is designed as a double-blind, placebo-controlled, event-driven study in which patients self-administer the drug outside the healthcare setting. The trial uses the same 70-milligram dose and repeat-dose regimen approved for CARDEMYST in PSVT. Oliveto said Milestone is labeling clinical study drug, has begun contracting with sites and has posted the trial on clinicaltrials.gov. The company expects to enroll the first patient in the second half of 2026. In response to a question, Oliveto said the study is expected to require about 150 to 200 total AFib RVR events and could enroll up to 600 patients across multiple countries and sites. He estimated the trial would take about two years from first patient enrolled to data, though he noted that timing depends on multiple variables. Chief Financial Officer Amit Hasija reported that Milestone had approximately $184 million in cash, cash equivalents and short-term investments as of March 31, compared with $106 million at the end of 2025. He said the cash balance is expected to support CARDEMYST launch activities and operations into the second half of 2027, including execution of ReVeRA-301. Product revenue: $0.2 million in the first quarter of 2026. R&D expense: $3.3 million, net of tax credits, compared with $5 million in the year-earlier quarter. G&A expense: $4.8 million, compared with $5.2 million a year earlier. Commercial expense: $15.8 million, compared with $10.4 million, reflecting additional costs tied to the CARDEMYST launch. Net loss: $26.1 million, or $0.20 per share, compared with $20.8 million, or $0.31 per share, in the first quarter of 2025. Hasija said the higher cash balance primarily reflected a $75 million cash payment received in January under Milestone’s royalty purchase agreement with RTW, as well as about $19 million in net proceeds from at-the-market sales and Series A warrant exercises during the quarter. Operating cash burn in the quarter was approximately $23.7 million. Oliveto said Milestone’s priorities for the rest of 2026 include disciplined launch execution, expanding payer access, advancing clinical development and managing resources responsibly. Milestone Pharmaceuticals, 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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Milestone Pharmaceuticals Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.