Andrew Callos
Analyst · Mizuho
Thank you, Robert. In the second quarter, the launch of MYQORZO continued to exhibit strong growth. While still early, we are encouraged by the steady progress we're seeing across physician awareness, prescribing activity, patient demand and market access. We believe these early indicators are beginning to demonstrate that the differentiated profile of MYQORZO is resonating well with both health care providers, payers and most importantly, also with patients. Since our commercial launch at the end of January, MYQORZO has accelerated quarter-over-quarter growth in new-to-brand prescriptions within the CMI category, by 24% in Q1 and 15% in Q2 compared to the single-digit growth rate observed when only a single CMI was available. The introduction of MYQORZO is helping drive increased breadth and depth of new patient starts as well as greater engagement and awareness among a broad range of physicians and prescribers within the category. In fact, in our most recent market research survey, which was conducted during the second quarter, unaided awareness among HCPs increased to 68% compared to 52% in the first quarter. We're also seeing encouraging engagement among patients. Our patient marketing campaign has driven early and increased awareness, resulting in over 30% awareness among oHCM patients in the United States. In addition, we have generated more than 390 million impressions and 2.1 million social media clicks through our focused and directed digital media campaigns across a broad range of channels and platforms. We're also pleased to see continuing perception of clinical differentiation favoring MYQORZO among HCPs. In our most recent physician survey conducted in May, HCPs are continuing to favor the clinical profile of MYQORZO. Treating physicians that we surveyed also view MYQORZO favorably across several attributes, including the convenience of dosing flexibility, safety and tolerability and the flexibility associated with differentiated REMS requirements. In this stage of our commercial launch, our emphasis remains on deepening prescribing among high-volume CMI prescribers. Historically, these physicians have generated approximately 80% of CMI prescriptions. While our call universe spans more than 10,000 health care providers we are prioritizing engagement with high-volume prescribers. And at the end of the second quarter, our sales team had reached more than 90% of these HCPs. We plan to maintain that same priority emphasis to high-volume prescribers until we achieve greater than 50% new-to-brand prescription share, which we believe could occur by the end of this year, if not sooner. At the same time, we're encouraged by the degree to which adoption is already broadening beyond the historically high-volume CMI writers. In fact, by the end of the second quarter, more than 50% of MYQORZO prescribers were either low-volume CMI prescribers or first-time CMI writers. Our field force reached more than half of these physicians during the second quarter. We see prescribing from this cohort as an important signal that MYQORZO is gaining traction across a wider segment in the oHCM treating community something we anticipated based on the differentiated profile of MYQORZO and it is validating to see that in actual prescribing. Importantly, our field-based teams are also bringing the data from MAPLE-HCM to the attention of the oHCM treating community. These important data from our second Phase III trial of aficamten both support findings from SEQUOIA-HCM and further demonstrate that MYQORZO is superior to beta-blocker metoprolol, an important point of differentiation that resonates with physicians to further reinforce the safety, efficacy and utility of MYQORZO in patients with oHCM. As we committed at launch, we continue to evaluate performance using 3 key metrics: breadth of prescribing measured by the number of HCPs who have written prescriptions, depth of prescribing measured by the number of patients to which each HCP prescribed MYQORZO, and patient volume, which reflects a total number of unique patients prescribed MYQORZO. Across all 3 metrics, we are encouraged by the progress and rate of growth achieved during the quarter. By the end of the quarter, more than 700 unique health care providers in the U.S. have prescribed MYQORZO including approximately 300 physicians from the high-volume CMI writer segment. On average, HCPs prescribed MYQORZO to approximately 3 of their patients, the figure is even higher among the subset of high-volume CMI writers who have now already prescribed MYQORZO to approximately 5 of their patients on average. Although limitations with syndicated data make it difficult to precisely calculate new-to-brand Q2 exit share in the CMI category, our internal analysis suggests that the exit share for MYQORZO has increased to greater than 40% in the second quarter. We also continue to see encouraging leading indicators of future demand, including more than 25 health care -- 2,500 health care providers who have now completed REMS certification since launch. Turning to patient demand. In the first quarter, we reported approximately 680 MYQORZO prescriptions, of which 400 were dispensed to patients by end of Q1. By the end of the second quarter, MYQORZO was dispensed to 1,500 patients, approximately nearly tripling the number of new patients dispensed MYQORZO in the quarter. The majority of prescriptions continue to be dispensed within approximately 3 weeks, once all patient documentation and benefits investigation is complete. Going forward, we plan to report on patient dispense versus prescriptions to better align with product revenue. In Q2, over 80% of the dispensed prescriptions were paid for with the remainder associated with either free trial, bridge or other patient assistance programs. These too are encouraging indicators of commercial launch growth and velocity. From an access perspective, we maintain our aspiration of broad coverage across key payer channels. We ended the quarter with nearly 90% parity coverage for Medicare lives. We also continue to broaden our commercial wide coverage achieving over 50% commercial coverage by quarter end and remain on track to achieve parity access by the end of 2026. Outside the United States, we successfully launched MYQORZO in Germany in June to support expanding access throughout Europe, we have also submitted 10 HTA dossiers across Europe reimbursement approval received effective August 1 in the Netherlands. And in England and Wales, NICE published guidance recommending MYQORZO for use as we continue to make progress broadening the pathway to further patient access, in key markets with additional markets anticipated to launch later this year during the first half of 2027. We are very encouraged by the performance we have seen in our launch markets. The launch velocity we are seeing reflects the differentiated profile of MYQORZO, but also the dedication and execution of our colleagues across the U.S. and Europe who are delivering excellence with both integrity and focus. And with that, I'll turn the call over to Fady.