Joseph Oliveto
Analyst · TD Cowen and Company
Thank you, Michael. Good morning, everyone, and thank you for joining us today to hear about our progress through the second quarter. Until this year, patients experiencing sudden attacks of paroxysmal supraventricular tachycardia, or PSVT, had no FDA-approved self-administered treatment available to them. Now a growing population of patients in the United States have CARDAMYST in their homes, in their workplaces, in their pockets or wherever it's convenient for them to have on hand to treat their PSVT. Today, we're excited to report on our first full financial quarter since our commercial launch in mid-February. We're seeing growing evidence that physicians, patients and payers recognize the value of CARDAMYST as a new treatment paradigm for PSVT. I'll start by taking you through total scripts, the number of unique prescribers and patients filling prescriptions. And we'll report these figures for the quarter, compare them to the prior quarter and add them for the first half results. Realize that the first quarter is a partial quarter and first half figures represent approximately 4.5 months of promotion between mid-February and the end of June. We'll also provide an update on market access coverage and how it has changed since our last investor call in May. For the second quarter of 2026 ending June 30, we continue to view the breadth of prescriber experience as one of the more important positive early indicators for the launch. More than 600 unique health care professionals wrote prescriptions for CARDAMYST in the second quarter compared with approximately 200 in the first quarter for a total of greater than 800 unique prescribers across the first half of the year. We recorded more than 1,200 total prescriptions in Q2 compared with approximately 300 in the first quarter, bringing the total prescriptions for the first half of 2026 to more than 1,500. And more than 1,000 patients received CARDAMYST in the second quarter compared with nearly 300 in the first quarter for a total of more than 1,300 patients in the first half of the year. As of today, we have secured formulary coverage, representing more than 50% of commercially insured lives. Most of this progress of additional coverage has come very recently, specifically in July and August. During the second quarter, coverage remained relatively unchanged at approximately 25% of commercially insured lives, which we reported on at our May investor call. Our recent crossing of the 50% commercially insured mark is an important achievement, which will enable increased access to CARDAMYST for patients in those plans as well as providing us with increased confidence for gaining coverage from additional plans. Lorenz will share further insights about the launch. But before turning the call over to Lorenz, I'll provide an update on the AFib-RVR program. From the start of our development of this novel compound and delivery system, our aim has been to shift appropriate acute care for tachycardias from the current treatment state, which is reactive and health care setting intensive to one that is proactive and patient empowering by enabling patients to treat themselves outside the hospital. We are now at an exciting intersection of both, fulfilling that promise for patients with PSVT and having begun the registrational Phase III stage of evaluating etripamil in the broader population of patients, those who experience atrial fibrillation with rapid ventricular rate, or AFib-RVR. We have begun our pivotal Phase III trial evaluating etripamil for treatment of AFib-RVR as announced in our last earnings release. Thanks to the efforts of the Milestone clinical team, our lead clinical sites are now active, and we expect our first patients to be enrolled shortly. We believe AFib-RVR represents a substantially larger opportunity for etripamil to help patients than it has for PSVT. Atrial fibrillation is a growing problem in the United States, estimated to impact over 10 million people. From this, we estimate an addressable population with burdensome symptomatic RVR of 3 million to 4 million patients. Somewhat like PSVT, patients with AFib-RVR experience symptomatic episodes and currently for AFib have limited and suboptimal self-administered treatment options. As a result, many of these episodes are managed in the emergency department using intravenous therapies or even electrical cardioversion. We're looking to leverage the strong and unique foothold that we have established in the cardiovascular space to address these current limitations. The design of our Phase III AFib study called ReVeRA-301 follows the same approach that was the basis for our successful Phase III program in PSVT. Patients self-administer study medication, either etripamil or placebo, in a double-blinded fashion at home in response to their symptoms using the same 70-milligram dose and repeat dose regimen that is already approved for CARDAMYST in PSVT. Many of the operational components of the study and many of the clinical sites are the same as those that were performed and performed well in our PSVT program. We believe this continuity between the 2 programs lowers our executional risk and reflects the experience we, meaning our team, the clinical investigators and our collaboration partners have built across the etripamil program. Our regulatory approach in AFib using our Phase III study is a single study supplemental New Drug Application, or sNDA. This is an efficient registrational pathway to a potential label expansion, and we will provide further updates on this program as it progresses. In addition to our progress toward an indication for AFib-RVR, we are progressing towards regulatory decisions in PSVT in Europe and China. If successful, these will expand access to etripamil globally. Our marketing application with the European Medicines Agency, or EMA, remains on track for a decision expected in the first half of 2027. For China, the engagement with the Chinese regulators is being carried by our partner, Everest Medicines. I will now turn the call over to Lorenz to cover our commercial progress in more detail.