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8/12/2026
Greetings. Welcome to the Milestone Pharma 2Q26 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Michael Wood from LifeSci Advisors. Thank you, Michael. You may begin.
Thank you and good morning, everyone, and welcome to Milestone Pharmaceuticals' second quarter 2026 financial results and business update conference call. Earlier this morning, the company issued a press release providing an overview of its financial results for the quarter ended June 30th, 2026 and recent corporate highlights. The release can be accessed on the investors' media section of the company's website, milestonepharma.com. Before we begin, I would like to remind you that some of the information presented on this conference call contains forward-looking statements under the securities laws. These forward-looking statements involve substantial risks and uncertainties that could cause actual clinical programs, future results, progress timing, performances, or achievements to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties associated with milestones, business, and factors that could cause or contribute to such differences are described in details in the company's filings with the SEC, including in the risk factors section of the annual report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 20, 2026. Speaking on the call today will be Joseph Oliveto, President and Chief Executive Officer, Lorenz Muller, Chief Commercial Officer, Chief Financial Officer and EVP of Corporate Development. In addition, Dr. David Bharucha, the company's Chief Medical Officer, will also be available during the Q&A session. I will now turn the call over to Joseph Oliveto. Please go ahead.
Thank you, Michael. Good morning, everyone, and thank you for joining us today to hear about our progress through the second quarter. Until this year, Patients experiencing sudden attacks of paroxysmal supraventricular tachycardia, or PSVT, had no FDA-approved self-administered treatment available to them. Now, a growing population of patients in the United States have cardamom in their homes, in their workplaces, in their pockets, or wherever it's convenient for them to have on hand to treat their PSVT. Today, we're excited to report on our first full financial quarter since our commercial launch in mid-February. We're seeing growing evidence that physicians, patients, and payers recognize the value of cardamom as a new treatment paradigm for PSVT. I'll start by taking you through total scripts, the number of unique prescribers, and patients filling prescriptions, and we'll report these figures for the quarter compare them to the prior quarter and add them for the first half results. Realize that the first quarter is a partial quarter and first half figures represent approximately four and a half months of promotion between mid-February and the end of June. We'll also provide an update on market access coverage and how it has changed since our last investor call in May. For the second quarter of 2026, ending June 30th, We continue to view the breadth of prescriber experience as one of the more important positive early indicators for the launch. More than 600 unique healthcare professionals wrote prescriptions for Cardamist in the second quarter compared with approximately 200 in the first quarter for a total of greater than 800 unique prescribers across the first half of the year. We recorded more than 1,200 total prescriptions in Q2 Compared with approximately 300 in the first quarter, bringing the total prescriptions for the first half of 2026 to more than 1,500. And more than 1,000 patients received cardamom in the second quarter, compared with nearly 300 in the first quarter, for a total of more than 1,300 patients in the first half of the year. As of today, we have secured formulary coverage representing more than 50% of commercially insured lives. Most of this progress of additional coverage has come very recently, specifically in July and August. During the second quarter, coverage remained relatively unchanged at approximately 25% of commercially insured lives, which we reported on at our May investor call. Our recent crossing of the 50% commercially insured mark is an important achievement, which will enable increased access to Cardamis for patients in those plans, as well as providing us with increased confidence for gaining coverage from additional plans. Lorenz will share further insights about the launch, but before turning the call over to Lorenz, I'll provide an update on the AFib-RVR program. From the start of our development of this novel compound and delivery system, our aim has been to shift appropriate acute care for tachycardias from the current treatment state, which is reactive and healthcare setting intensive, to one that is proactive and patient empowering by enabling patients to treat themselves outside the hospital. We are now at an exciting intersection of both fulfilling that promise for patients with PSVT and having begun the Registrational Phase III stage of evaluating atripomil in the broader population of patients, those who experience atrial fibrillation with rapid ventricular rate or AFib-RVR. We have begun our pivotal Phase III trial evaluating atripomil for treatment of AFib-RVR as announced in our last learnings release. Thanks to the efforts of the Milestone Clinical Team, our lead clinical sites are now active and we expect our first patients to be enrolled shortly. We believe AFib-RVR represents a substantially larger opportunity for Atripamil to help patients than it has for PSVT. Atrial fibrillation is a growing problem in the United States, estimated to impact over 10 million people. From this, we estimate an addressable population with burdensome symptomatic RVR of 3 to 4 million patients. Somewhat like PSVT, patients with AFib RVR experience symptomatic episodes and currently for AFib have limited and suboptimal self-administered treatment options. As a result, many of these episodes are managed in the emergency department using intravenous therapies or even electrical cardioversion. We're looking to leverage the strong and unique foothold that we have established in the cardiovascular space to address these current limitations. The design of our Phase III AFib study, called Rivera 301, follows the same approach that was the basis for our successful Phase III program in PSVT. Patients self-administer study medication, either a triple molar placebo in a double-blended fashion, at home in response to their symptoms using the same 70 milligram dose and repeat dose regimen that is already approved for Cardamis and PSVT. Many of the operational components of the study and many of the clinical sites are the same as those that were performed and performed well in our PSVT program. We believe this continuity between the two programs lowers our executional risk and reflects the experience we, meaning our team, the clinical investigators and our collaboration partners have built across the ATRIPAMIL program. Our regulatory approach in AFib using our phase three study is a single study supplemental new drug application or SMDA. This is an efficient registrational pathway to a potential label expansion and we will provide further updates on this program as it progresses. In addition to our progress toward an indication for AFib-RVR, we are progressing towards regulatory decisions in PSVT in Europe and China. If successful, these will expand access to atrypamil globally. Our marketing application with the European Medicines Agency, or EMA, remains on track for a decision expected in the first half of 2027. The engagement with the Chinese regulators is being carried by our partner, Everest Medicines. I will now turn the call over to Lorenz to cover our commercial progress in more detail.
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