Q2 2026 Cytokinetics Inc Earnings Call

Speaker #1: Thank you for standing by, and welcome to the CYTOKINETICS Q2, 2026 earnings conference call. This call is being recorded and all participants are in a listen-only mode.

Operator: Thank you for standing by, and welcome to the Cytokinetics Q2 2026 earnings conference call. This call is being recorded, and all participants are in a listen-only mode. After the speakers' remarks, we will open the call to questions. We will allow for one question per participant. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. I would now like to turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate Affairs. Diane, please go ahead.

Operator: Thank you for standing by, and welcome to the Cytokinetics Q2 2026 Earnings Conference Call. This call is being recorded, and all participants are in a listen-only mode. After the speakers' remarks, we will open the call to questions. We will allow for one question per participant. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. I would now like to turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate Affairs. Diane, please go ahead.

Speaker #1: your telephone keypad. If you would like to withdraw your question, press star one again. I would now like to turn the call over to Diane Weiser, Cytokinetics Senior Vice President of Corporate Affairs.

Speaker #1: Diane, please go ahead.

Speaker #2: Good afternoon, and thanks for joining us on the call today. The slides accompanying today's webcast can be found on the Investors and Media section of our website, at cytokinetics.com, along with today's press release.

Diane Weiser: Good afternoon, and thanks for joining us on the call today. The slides accompanying today's webcast can be found on the Investors and Media section of our website at cytokinetics.com, along with today's press release. Robert Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent developments. Andrew Callos, EVP and Chief Commercial Officer, will discuss the commercial launch of MYQORZO in the US and Europe. Fady Malik, EVP of R&D, will provide updates related to aficamten. Steve Hytner, SVP and Chief Medical Officer, will provide updates related to our ongoing clinical development program. Sung Lee, EVP and Chief Financial Officer, will provide a financial overview for the quarter. Finally, Robert will make closing remarks and review key milestones for the year ahead. As you can see on this slide, today's discussion will include forward-looking statements which are subject to risks and uncertainties.

Diane Weiser: Good afternoon, and thanks for joining us on the call today. The slides accompanying today's webcast can be found on the Investors and Media section of our website at cytokinetics.com, along with today's press release. Robert Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent developments. Andrew Callos, EVP and Chief Commercial Officer, will discuss the commercial launch of MYQORZO in the US and Europe.

Speaker #2: Robert Blum, President and Chief Executive Officer, will begin with an overview of the quarter and recent developments. Andrew Callos, EVP and Chief Commercial Officer, will discuss the commercial launch of myCorso in the U.S.

Speaker #2: and Europe. Fady Malik, EVP of R&D, will provide updates related to API Campton. Steve Heitner, SVP and Chief Medical Officer, will provide updates related to our ongoing clinical development program.

Diane Weiser: Fady Malik, EVP of R&D, will provide updates related to aficamten. Steve Hytner, SVP and Chief Medical Officer, will provide updates related to our ongoing clinical development program. Sung Lee, EVP and Chief Financial Officer, will provide a financial overview for the quarter. Finally, Robert will make closing remarks and review key milestones for the year ahead. As you can see on this slide, today's discussion will include forward-looking statements which are subject to risks and uncertainties. Please refer to our SEC filings for a discussion of these factors. Now I will turn the call over to Robert.

Speaker #2: Sung Lee, EVP and Chief Financial Officer, will provide a financial overview for the quarter. And finally, Robert will make closing remarks and review key milestones for the year ahead.

Speaker #2: As you can see on the slide, today's discussion will include forward-looking statements, which are subject to risks and uncertainties. Please refer to our SEC filings for discussion of these factors.

Diane Weiser: Please refer to our SEC filings for a discussion of these factors. Now I will turn the call over to Robert.

Speaker #2: And now, I will turn the call over to Robert.

Speaker #1: Thank you, Diane. And thanks to all for joining us on the call today. The second quarter was another solid period of execution for CYTOKINETICS, marked by strong commercial momentum, per myCorso in the United States, our first European launch in Germany, progress toward additional market access globally, potential regulatory milestones internationally, and continued advancement of our later-stage specialty cardiology pipeline.

Robert Blum: Thank you, Diane, and thanks to all for joining us on the call today. The Q2 was another solid period of execution for Cytokinetics, marked by strong commercial momentum for MYQORZO in the United States, our first European launch in Germany, progress towards additional market access globally, potential regulatory milestones internationally, and continued advancement of our later-stage specialty cardiology pipeline. Just five months into the commercial launch of MYQORZO, we are demonstrating increased velocity that's exceeding expectations. As Andrew will discuss, growth in prescribing and dispensing for MYQORZO reflects increasing awareness and physician engagement, expanding patient access, and adoption across multiple segments of the targeted prescriber base. All of which reinforce confidence in MYQORZO and its clinical, therapeutic, and commercial opportunities.

Robert Blum: Thank you, Diane, and thanks to all for joining us on the call today. The Q2 was another solid period of execution for Cytokinetics, marked by strong commercial momentum for MYQORZO in the United States, our first European launch in Germany, progress towards additional market access globally, potential regulatory milestones internationally, and continued advancement of our later-stage specialty cardiology pipeline.

Speaker #1: Just 5 months into the commercial launch of myCorso, we are demonstrating increased velocity that's exceeding expectations. As Andrew will discuss, growth in prescribing and dispensing for myCorso reflects increasing awareness and physician engagement, expanding patient access, and adoption across multiple segments of the targeted prescriber base.

Robert Blum: Just five months into the commercial launch of MYQORZO, we are demonstrating increased velocity that's exceeding expectations. As Andrew will discuss, growth in prescribing and dispensing for MYQORZO reflects increasing awareness and physician engagement, expanding patient access, and adoption across multiple segments of the targeted prescriber base. All of which reinforce confidence in MYQORZO and its clinical, therapeutic, and commercial opportunities.

Speaker #1: All of which reinforce confidence in myCorso and its clinical, therapeutic, and commercial opportunities. During the quarter, we also executed well on our global commercialization strategy, with the launch of myCorso in Germany, the first in a series of European launches expected over the next 6 to 12 months.

Robert Blum: During the quarter, we also executed well on our global commercialization strategy with the launch of MYQORZO in Germany, the first in a series of European launches expected over the next six to 12 months. This is a key milestone for Cytokinetics and for patients in Europe, and it serves as the foundation upon which we will build broader access across Europe and beyond over the coming years. To that end, more recently, the MHRA granted MYQORZO marketing authorization across the United Kingdom for the treatment of symptomatic OHCM in adult patients. At the same time, NICE issued guidance recommending MYQORZO for use in England and Wales. We're pleased that the concurrent regulatory approval and reimbursement recommendation will help MYQORZO reach patients sooner. We expect drug supply and full launch in the UK later this year.

Robert Blum: During the quarter, we also executed well on our global commercialization strategy with the launch of MYQORZO in Germany, the first in a series of European launches expected over the next six to 12 months. This is a key milestone for Cytokinetics and for patients in Europe, and it serves as the foundation upon which we will build broader access across Europe and beyond over the coming years.

Speaker #1: This is a key milestone for CYTOKINETICS and for patients in Europe, and it serves as the foundation upon which we will build broader access across Europe and beyond over the coming recently, the MHRA granted myCorso marketing authorization across the United Kingdom for the treatment of symptomatic OHCM in adult patients.

Robert Blum: To that end, more recently, the MHRA granted MYQORZO marketing authorization across the United Kingdom for the treatment of symptomatic OHCM in adult patients. At the same time, NICE issued guidance recommending MYQORZO for use in England and Wales. We're pleased that the concurrent regulatory approval and reimbursement recommendation will help MYQORZO reach patients sooner. We expect drug supply and full launch in the UK later this year.

Speaker #1: And at the same time, NICE issued guidance recommending myCorso for use in England and Wales. We're pleased that the concurrent regulatory approval and reimbursement recommendation will help myCorso reach patients sooner.

Speaker #1: We expect drug supply and full launch in the U.K. later this year. During the second quarter, we highlighted the opportunity for API Campton to potentially treat the full-spectrum of HCM, as we shared, the top-line results from Acacia HCM in patients with nonobstructive HCM showed that the phase 3 trial met both of its dual primary endpoints: demonstrating statistically significant improvements from baseline to week 36 in both KCCQ clinical summary score and peak VO2, compared to placebo.

Robert Blum: During the Q2, we highlighted the opportunity for aficamten to potentially treat the full spectrum of HCM. As we shared, the top-line results from ACACIA-HCM in patients with non-obstructive HCM showed that the phase III trial met both of its dual primary endpoints, demonstrating statistically significant improvements from baseline to week 36 in both KCCQ clinical summary score and peak VO2 compared to placebo. These results represent an important scientific achievement for an NHCM patient population with no currently approved therapies. They define a meaningful step toward expanding the potential reach of aficamten beyond OHCM, subject, of course, to regulatory review and subsequent potential approval. Following our announcement of the top-line results from ACACIA-HCM, we met with the FDA to discuss our next steps. We reviewed the clinical trial results together. We posed questions to which the FDA responded.

Robert Blum: During the Q2, we highlighted the opportunity for aficamten to potentially treat the full spectrum of HCM. As we shared, the top-line results from ACACIA-HCM in patients with non-obstructive HCM showed that the phase III trial met both of its dual primary endpoints, demonstrating statistically significant improvements from baseline to week 36 in both KCCQ clinical summary score and peak VO2 compared to placebo.

Speaker #1: These results represent an important scientific achievement for an NHCM patient population with no currently approved therapies and they define a meaningful step toward expanding the potential reach of API Campton beyond OHCM.

Robert Blum: These results represent an important scientific achievement for an NHCM patient population with no currently approved therapies. They define a meaningful step toward expanding the potential reach of aficamten beyond OHCM, subject, of course, to regulatory review and subsequent potential approval. Following our announcement of the top-line results from ACACIA-HCM, we met with the FDA to discuss our next steps. We reviewed the clinical trial results together. We posed questions to which the FDA responded.

Speaker #1: Subject, of course, to regulatory review and subsequent potential approval. Following our announcement of the top-line results from Acacia HCM, we met with the FDA to discuss our next steps.

Speaker #1: We reviewed the clinical trial results together, and we posed questions to which the FDA responded. Those discussions and the FDA feedback now inform our plan to submit a supplemental NDA for API Campton in NHCM in the fourth quarter of this year.

Robert Blum: Those discussions and the FDA feedback now inform our plan to submit a supplemental NDA for aficamten in NHCM in the Q4 of this year. We also plan to meet with EU regulators to hold similar discussions in support of future potential regulatory submissions in Europe. In the meantime, we look forward to presenting the full results from ACACIA-HCM in a hotline session at the European Society of Cardiology Congress to occur later this month. Alongside progress towards making MYQORZO available to more patients with OHCM in the United States and internationally, we're prioritizing potential regulatory approvals for aficamten in patients with NHCM, as could lead to MYQORZO being the only approved therapy for patients across the wider spectrum of HCM.

Robert Blum: Those discussions and the FDA feedback now inform our plan to submit a supplemental NDA for aficamten in NHCM in the Q4 of this year. We also plan to meet with EU regulators to hold similar discussions in support of future potential regulatory submissions in Europe. In the meantime, we look forward to presenting the full results from ACACIA-HCM in a hotline session at the European Society of Cardiology Congress to occur later this month.

Speaker #1: We also plan to meet with EU regulators to hold similar discussions in support of future potential regulatory submissions in Europe. In the meantime, we look forward to presenting the full results from Acacia HCM in a hotline session at the European Society of Cardiology next month.

Speaker #1: Alongside progress toward making myCorso available to more patients with OHCM in the United States and internationally, we're prioritizing potential regulatory approvals for API Campton and as could lead to myCorso being the only approved therapy for patients across the wider spectrum of HCM.

Robert Blum: Alongside progress towards making MYQORZO available to more patients with OHCM in the United States and internationally, we're prioritizing potential regulatory approvals for aficamten in patients with NHCM, as could lead to MYQORZO being the only approved therapy for patients across the wider spectrum of HCM.

Speaker #1: Moreover, in the second quarter, as you'll hear, we continue to advance our later-stage specialty cardiology pipeline, with further progress evidenced in important clinical trials for novel drug candidates that have emerged from our pioneering leadership in innovative muscle biology and pharmacology.

Robert Blum: Moreover, in the Q2, as you'll hear, we continued to advance our later-stage specialty cardiology pipeline with further progress evidenced in important clinical trials for novel drug candidates that have emerged from our pioneering leadership in innovative muscle biology and pharmacology. We fortified our balance sheet with a successful financing that supports our plans and objectives. Taken altogether, the progress we made this Q2 underscores that Cytokinetics is executing well on a global commercial stage and integrated biopharmaceutical company. We're building commercial growth and velocity, expanding global scale and access, proceeding towards expanded product labeling, and advancing pipeline, all with focus and discipline to capital access and allocation. I look forward to sharing more about that now from our colleagues. With that, I'll turn the call over to Andrew.

Robert Blum: Moreover, in the Q2, as you'll hear, we continued to advance our later-stage specialty cardiology pipeline with further progress evidenced in important clinical trials for novel drug candidates that have emerged from our pioneering leadership in innovative muscle biology and pharmacology. We fortified our balance sheet with a successful financing that supports our plans and objectives.

Speaker #1: And we fortified our balance sheet with a successful financing that supports our plans and objectives. Taken all together, the progress we made this second quarter underscores that CYTOKINETICS is executing well on a global commercial stage and integrated biopharmaceutical company.

Robert Blum: Taken altogether, the progress we made this Q2 underscores that Cytokinetics is executing well on a global commercial stage and integrated biopharmaceutical company. We're building commercial growth and velocity, expanding global scale and access, proceeding towards expanded product labeling, and advancing pipeline, all with focus and discipline to capital access and allocation. I look forward to sharing more about that now from our colleagues. With that, I'll turn the call over to Andrew.

Speaker #1: We're building commercial growth and velocity expanding global scale and access, proceeding toward expanded product labeling and advancing pipeline. All with focus and discipline to capital access and allocation.

Speaker #1: I look forward to sharing more about that now from our colleagues. And with that, I'll turn the call over to Andrew.

Speaker #3: Thank you, Robert. In the second quarter, the launch of myCorso 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.

Andrew Callos: Thank you, Robert. In Q2, the launch of MYQORZO continued to exhibit strong growth. While still early, we are encouraged by the steady progress we are 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 healthcare 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.

Andrew Callos: Thank you, Robert. In Q2, the launch of MYQORZO continued to exhibit strong growth. While still early, we are encouraged by the steady progress we are 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 healthcare providers, payers, and most importantly, also with patients.

Speaker #3: We believe these early indicators are beginning to demonstrate that the differentiated profile of myCorso is resonating well with both healthcare providers, payers, and most importantly, also with patients.

Speaker #3: Since our commercial launch at the end of January, myCorso 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.

Andrew Callos: 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.

Speaker #3: The introduction of myCorso 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.

Speaker #3: 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.

Andrew Callos: In fact, in our most recent market research survey, which was conducted during Q2, unaided awareness among HCPs increased to 68%, compared to 52% in Q1. We are 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 US. 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 are 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.

Andrew Callos: In fact, in our most recent market research survey, which was conducted during Q2, unaided awareness among HCPs increased to 68%, compared to 52% in Q1. We are 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 US.

Speaker #3: We are 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.

Speaker #3: 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.

Andrew Callos: 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 are 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.

Speaker #3: We're also pleased to see continuing perception of clinical differentiation favoring myCorso among HCPs. In our most recent physician survey conducted in May, HCPs are continuing to favor the clinical profile of myCorso, treating physicians that we surveyed also view myCorso favorably across several attributes, including the convenience of dosing flexibility, safety and tolerability, and in the flexibility associated with differentiated REMS requirements.

Andrew Callos: 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 whole universe spans in more than 10,000 healthcare providers, we are prioritizing engagement with high-volume prescribers, and at the end of Q2, 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 2024, if not sooner. At the same time, we are encouraged by the degree to which adoption is already broadening beyond the historically high-volume CMI writers.

Andrew Callos: 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.

Speaker #3: 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.

Speaker #3: While our whole universe spans in more than 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.

Andrew Callos: While our whole universe spans in more than 10,000 healthcare providers, we are prioritizing engagement with high-volume prescribers, and at the end of Q2, 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 2024, if not sooner. At the same time, we are encouraged by the degree to which adoption is already broadening beyond the historically high-volume CMI writers.

Speaker #3: 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.

Speaker #3: At the same time, we're encouraged by the degree to which adoption has already broadening beyond the historically high-volume CMI writers. In fact, by the end of the second quarter, more than 50% of myCorso prescribers were either low-volume CMI prescribers or first-time CMI writers.

Andrew Callos: In fact, by the end of Q2, 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 Q2. 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.

Andrew Callos: In fact, by the end of Q2, 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 Q2. 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.

Speaker #3: 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 myCorso is gaining traction across a wider segment in the OHCM treating community, something we anticipate based on the differentiated profile of myCorso and its validating to see that in actual prescribing.

Speaker #3: 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 three trial of APTI Campton both support findings from Sequoia HCM and further demonstrate that myCorso is superior to beta blocker metoprolol and important point of differentiation that resonates with physicians to further reinforce the safety efficacy and utility of myCorso in patients with OHCM.

Andrew Callos: 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 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.

Andrew Callos: These important data from our 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 three 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. Patient volume, which reflects the total number of unique patients prescribed MYQORZO. Across all three metrics, we are encouraged by the progress and rate of growth achieved during the quarter.

Speaker #3: As we committed at launch, we continue to evaluate performance using three 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 myCorso; and patient volume, which reflects a total number of unique patients prescribed myCorso.

Andrew Callos: As we committed at launch, we continue to evaluate performance using three 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. Patient volume, which reflects the total number of unique patients prescribed MYQORZO. Across all three metrics, we are encouraged by the progress and rate of growth achieved during the quarter.

Speaker #3: Across all three metrics, we growth achieved during the quarter. By the end of the quarter, more than 700 unique healthcare providers in the US had prescribed myCorso, including approximately 300 physicians from the high-volume CMI writer segment.

Andrew Callos: By the end of the quarter, more than 700 unique healthcare providers in the US had prescribed MYQORZO, including approximately 300 physicians from the high-volume CMI writer segment. On average, HCPs prescribed MYQORZO to approximately three of their patients. The figure is even higher among the subset of high-volume CMI writers who have now already prescribed MYQORZO to approximately five 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 Q2. We also continue to see encouraging leading indicators of future demand, including more than 2,500 healthcare providers who have now completed REMS certification since launch.

Andrew Callos: By the end of the quarter, more than 700 unique healthcare providers in the US had prescribed MYQORZO, including approximately 300 physicians from the high-volume CMI writer segment. On average, HCPs prescribed MYQORZO to approximately three of their patients. The figure is even higher among the subset of high-volume CMI writers who have now already prescribed MYQORZO to approximately five of their patients on average.

Speaker #3: On average, HCPs prescribed myCorso to approximately three of their patients, the figure is even higher among the subset of high-volume CMI writers who have now already prescribed myCorso to approximately five of their patients on average.

Speaker #3: 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 myCorso has increased to greater than 40% in the second quarter.

Andrew Callos: 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 Q2. We also continue to see encouraging leading indicators of future demand, including more than 2,500 healthcare providers who have now completed REMS certification since launch.

Speaker #3: We also continue to see encouraging leading indicators of future demand, including more than 2,500 healthcare providers who have now completed REMS certification since launch.

Speaker #3: Turning to patient demand in the first quarter, we reported approximately 680 myCorso prescriptions, of which 400 were dispensed to patients by end of Q1.

Andrew Callos: Turning to patient demand, in Q1, we reported approximately 680 MYQORZO prescriptions, of which 400 were dispensed to patients by end of Q1. By the end of Q2, MYQORZO was dispensed to 1,500 patients, approximately nearly tripling the number of new patients dispensed MYQORZO in the quarter. The majority of prescriptions continued 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 program. These two are encouraging indicators of commercial launch growth and velocity. From an access perspective, we maintain our aspiration of broad coverage across key payer channels.

Andrew Callos: Turning to patient demand, in Q1, we reported approximately 680 MYQORZO prescriptions, of which 400 were dispensed to patients by end of Q1. By the end of Q2, MYQORZO was dispensed to 1,500 patients, approximately nearly tripling the number of new patients dispensed MYQORZO in the quarter. The majority of prescriptions continued to be dispensed within approximately 3 weeks once all patient documentation and benefits investigation is complete.

Speaker #3: By the end of the second quarter, myCorso was dispensed to 1,500 patients, approximately nearly tripling the number of new patients dispensed myCorso in the quarter.

Speaker #3: The majority of prescriptions continued to be dispensed within approximately three 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.

Andrew Callos: 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 program. These two are encouraging indicators of commercial launch growth and velocity. From an access perspective, we maintain our aspiration of broad coverage across key payer channels.

Speaker #3: In Q2, over 80% of the dispensed prescriptions were paid for, with the remainder associated with either free trial, bridge, or other patient assistance program.

Speaker #3: These two are encouraging indicators of commercial launch growth and velocity. From an access perspective, we maintain our aspiration of broad coverage across key payer channels.

Speaker #3: We ended the quarter with nearly 90% parity, coverage for Medicare lives, we also continue to broaden our commercial lives coverage, achieving over 50% commercial coverage by quarter end, and remain on track to achieve parity access by the end of 2026.

Andrew Callos: We end up the quarter with nearly 90% parity coverage for Medicare lives. We also continue to broaden our commercial lives 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 with reimbursement approval received effective 1 August in the Netherlands. 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 H1 2027. We are very encouraged by the performance we have seen in our launch markets.

Andrew Callos: We end up the quarter with nearly 90% parity coverage for Medicare lives. We also continue to broaden our commercial lives 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.

Speaker #3: Outside the United States, we successfully launched myCorso in Germany in June. To support expanding access throughout Europe, we have also submitted 10 HTA dossiers across Europe with reimbursement approval received effective August 1st in the Netherlands.

Andrew Callos: To support expanding access throughout Europe, we have also submitted 10 HTA dossiers across Europe with reimbursement approval received effective 1 August in the Netherlands. 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 H1 2027. We are very encouraged by the performance we have seen in our launch markets.

Speaker #3: And in England and Wales, NICE published guidance recommending myCorso for use as we continue to make progress broadening the pathway to further patient access.

Speaker #3: 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.

Speaker #3: The launch velocity we are seeing reflects a differentiated profile of myCorso but also the dedication and execution of our colleagues across the US and Europe who are delivering excellence with both integrity and focus.

Andrew Callos: The launch velocity we are seeing reflects a differentiated profile of MYQORZO, but also the dedication and execution of our colleagues across the US and Europe who are delivering excellence with both integrity and focus. With that, I'll turn the call over to Fady.

Andrew Callos: The launch velocity we are seeing reflects a differentiated profile of MYQORZO, but also the dedication and execution of our colleagues across the US and Europe who are delivering excellence with both integrity and focus. With that, I'll turn the call over to Fady.

Speaker #3: And with that, I'll turn the call over to Fady.

Speaker #1: Thanks, Andrew. The second quarter was an important period for HCM portfolio. Most notably, with our announcement of positive top-line results from Acacia HCM, our pivotal phase three clinical trial and patients with symptomatic NHCM.

Fady Malik: Thanks, Andrew. The Q2 was an important period for our HCM portfolio, most notably with our announcement of positive top-line results from ACACIA-HCM, our pivotal phase III clinical trial in patients with symptomatic NHCM. As we shared by top-line press release in May, ACACIA-HCM met both dual primary endpoints, demonstrating statistically significant improvements from baseline to week 36 in both KCCQ clinical summary score and peak VO2 compared to placebo. In addition, statistically significant improvements compared to placebo were observed across key secondary endpoints, and no new safety signals were identified. We believe these findings are particularly meaningful because they demonstrate the potential of aficamten in NHCM, which represents as much as one-half or more of the overall HCM population, and for which there are no currently approved therapies. For many years, treatment options for patients with NHCM have been limited, despite the significant burden associated with the disease.

Fady Malik: Thanks, Andrew. The Q2 was an important period for our HCM portfolio, most notably with our announcement of positive top-line results from ACACIA-HCM, our pivotal phase III clinical trial in patients with symptomatic NHCM. As we shared by top-line press release in May, ACACIA-HCM met both dual primary endpoints, demonstrating statistically significant improvements from baseline to week 36 in both KCCQ clinical summary score and peak VO2 compared to placebo.

Speaker #1: As we shared by top-line press release in May, Acacia HCM met both dual primary endpoints demonstrating statistically significant improvements from baseline to week 36 in both KCCQ clinical summary score and peak VO2 compared to placebo.

Speaker #1: In addition, statistically significant improvements compared to placebo were observed across key secondary endpoints and no new safety signals were identified. We believe these findings are particularly meaningful because they demonstrate the potential of APTI Campton in NHCM, which represents as much as one half or more of the overall HCM population.

Fady Malik: In addition, statistically significant improvements compared to placebo were observed across key secondary endpoints, and no new safety signals were identified. We believe these findings are particularly meaningful because they demonstrate the potential of aficamten in NHCM, which represents as much as one-half or more of the overall HCM population, and for which there are no currently approved therapies. For many years, treatment options for patients with NHCM have been limited, despite the significant burden associated with the disease.

Speaker #1: And for which there are no currently approved therapies. For many years, treatment options for patients with NHCM have been limited despite the significant burden associated with the disease.

Speaker #1: We believe the results from ACACIA-HCM represent an important step toward potentially changing that treatment paradigm. Later this month, we look forward to presenting the primary results from ACACIA-HCM during a hotline session at the European Society of Cardiology Congress.

Fady Malik: We believe the results from ACACIA-HCM represent an important step towards potentially changing that treatment paradigm. Later this month, we look forward to presenting the primary results from ACACIA-HCM during a hotline session at the European Society of Cardiology Congress. Alongside the presentation of the primary results, which will provide a more comprehensive and detailed look at the results for both primary endpoints, secondary endpoints, and of course, safety. We'll also be presenting additional analyses regarding the effect of aficamten on cardiac structure and function in a separate late-breaker session to help further inform treatment effect of aficamten in this population. At ESC, we also plan to hold an event both in person and online for investors and analysts to hear perspectives and insights on the results from prominent HCM KOLs.

Fady Malik: We believe the results from ACACIA-HCM represent an important step towards potentially changing that treatment paradigm. Later this month, we look forward to presenting the primary results from ACACIA-HCM during a hotline session at the European Society of Cardiology Congress. Alongside the presentation of the primary results, which will provide a more comprehensive and detailed look at the results for both primary endpoints, secondary endpoints, and of course, safety.

Speaker #1: Alongside the presentation of the primary results, which will provide a more comprehensive and detailed look at the results for both primary endpoints, secondary endpoints, and of course safety, we'll also be presenting additional analyses regarding the effect of APTI Campton on cardiac structure and function, and a separate late-breaker session to help further inform the treatment effect of APTI Campton in this population.

Fady Malik: We'll also be presenting additional analyses regarding the effect of aficamten on cardiac structure and function in a separate late-breaker session to help further inform treatment effect of aficamten in this population. At ESC, we also plan to hold an event both in person and online for investors and analysts to hear perspectives and insights on the results from prominent HCM KOLs.

Speaker #1: At ESC, we also plan to hold an event both in person and online for investors and analysts to hear perspectives and insights on the results from prominent HCM KOLs.

Speaker #1: As Robert mentioned, after we shared the top-line results publicly, we then met with the FDA to discuss the results of ACACIA-HCM and next steps for Aficamten.

Fady Malik: As Robert mentioned, after we shared the top-line results publicly, we then met with FDA to discuss the results of ACACIA-HCM and next steps for aficamten, which informed our plan to submit an sNDA expected during the Q4 of this year. While we prepare for that filing, we also expect to engage with European regulatory authorities in a similar fashion regarding a potential submission to the European Medicines Agency. There is still much work ahead, but the positive top-line results and our regulatory interactions to date reinforce our continued confidence in opportunities for aficamten in NHCM. In OHCM, we continue to support review activities and engage constructively with FDA regarding the sNDA based on MAPLE-HCM that's currently under review, with a PDUFA date of 14 November 2026.

Fady Malik: As Robert mentioned, after we shared the top-line results publicly, we then met with FDA to discuss the results of ACACIA-HCM and next steps for aficamten, which informed our plan to submit an sNDA expected during the Q4 of this year. While we prepare for that filing, we also expect to engage with European regulatory authorities in a similar fashion regarding a potential submission to the European Medicines Agency.

Speaker #1: Which informed our plan to submit a supplemental NDA. Expected during the fourth quarter of this year. While we prepare for that filing, we also expect to engage with European regulatory authorities in a similar fashion regarding a potential submission to the European Medicines Agency.

Speaker #1: There is still much work ahead, but the positive top-line results and our regulatory interactions to date reinforce our continued confidence in opportunities for APTI Campton in NHCM.

Fady Malik: There is still much work ahead, but the positive top-line results and our regulatory interactions to date reinforce our continued confidence in opportunities for aficamten in NHCM. In OHCM, we continue to support review activities and engage constructively with FDA regarding the sNDA based on MAPLE-HCM that's currently under review, with a PDUFA date of 14 November 2026.

Speaker #1: In OHCM, we continue to support review activities engaged and engaged constructively with FDA regarding the SNDA based on Maple HCM. That's currently under review.

Speaker #1: With a PDUFA date of November 14th, 2026. We continue to believe that the results from Maple HCM have the potential to meaningfully inform treatment guidelines and clinical practice by providing evidence supporting the use of APTI Campton as an earlier treatment option in appropriate patients.

Fady Malik: We continue to believe that the results from MAPLE-HCM have the potential to meaningfully inform treatment guidelines and clinical practice by providing evidence supporting the use of aficamten as an earlier treatment option in appropriate patients. In the meantime, given that the efficacy and safety profile of aficamten observed in MAPLE-HCM are consistent with our labeling, our field medical team have been sharing these results with potential prescribers. In addition, our field medical team continued to support the launch of MYQORZO and completed more than 800 scientific exchanges with US-based HCPs across a variety of topics, including questions related to the USPI and our public announcement of the results from ACACIA-HCM. Our medical science liaisons also supported our cardiovascular account specialists, or CASs, with introductory HCP meetings. During the quarter, our medical colleagues were pleased to support the initiation of our first-ever investigator-initiated research study utilizing aficamten.

Fady Malik: We continue to believe that the results from MAPLE-HCM have the potential to meaningfully inform treatment guidelines and clinical practice by providing evidence supporting the use of aficamten as an earlier treatment option in appropriate patients. In the meantime, given that the efficacy and safety profile of aficamten observed in MAPLE-HCM are consistent with our labeling, our field medical team have been sharing these results with potential prescribers.

Speaker #1: In the meantime, given that the FDA and safety profile of APTI Campton observed in Maple HCM are consistent with our labeling, our field medical team have been sharing these results with potential prescribers.

Speaker #1: In addition, our field medical team continued to support the launch of myCorso. They completed more than 800 scientific exchanges with US-based HCPs, across a variety of topics, including questions related to the USPI and our public announcement of the results from ACACIA-HCM.

Fady Malik: In addition, our field medical team continued to support the launch of MYQORZO and completed more than 800 scientific exchanges with US-based HCPs across a variety of topics, including questions related to the USPI and our public announcement of the results from ACACIA-HCM. Our medical science liaisons also supported our cardiovascular account specialists, or CASs, with introductory HCP meetings. During the quarter, our medical colleagues were pleased to support the initiation of our first-ever investigator-initiated research study utilizing aficamten.

Speaker #1: Our medical science liaisons also supported our cardiovascular account specialists, our CASs, with introductory HCP meetings. During the quarter, our medical colleagues were pleased to support the initiation of our first ever investigator-initiated research study utilizing APTI Campton.

Speaker #1: Studies investigating the feasibility, safety, and efficacy of physician seamlessly transitioning patients from APTI Campton to APTI Campton in patients with OHCM. Taken together, the progress made this quarter reinforces our conviction in the potential role of APTI Campton to address the full spectrum of HCM.

Fady Malik: Studies investigating the feasibility, safety, and efficacy of physicians seamlessly transitioning patients from mavacamten to aficamten in patients with OHCM. Taken together, the progress made this quarter reinforces our conviction in the potential role of aficamten to address the full spectrum of HCM. With MYQORZO now available for adults with symptomatic OHCM and the positive results from ACACIA-HCM supporting a potential expansion into NHCM, we continue to see a substantial opportunity to bring this medicine to a broader population of patients in the United States and also around the world. I'm pleased to hand it over to Steve Heitner. Before I do, I'd like to formally announce that Steve has been promoted to Chief Medical Officer.

Fady Malik: Studies investigating the feasibility, safety, and efficacy of physicians seamlessly transitioning patients from mavacamten to aficamten in patients with OHCM. Taken together, the progress made this quarter reinforces our conviction in the potential role of aficamten to address the full spectrum of HCM.

Speaker #1: With myCorso now available for patients—and I mean, for adults with symptomatic oHCM—and the positive results from Acacia HCM supporting a potential expansion into nHCM, we continue to see a substantial opportunity to bring this medicine to a broader population of patients in the United States and also around the world.

Fady Malik: With MYQORZO now available for adults with symptomatic OHCM and the positive results from ACACIA-HCM supporting a potential expansion into NHCM, we continue to see a substantial opportunity to bring this medicine to a broader population of patients in the United States and also around the world. I'm pleased to hand it over to Steve Heitner. Before I do, I'd like to formally announce that Steve has been promoted to Chief Medical Officer.

Speaker #1: Next, I'm pleased to hand it over to Steve Heidner. But before I do, I'd like to formally announce that Steve has been promoted to chief medical officer.

Speaker #1: Steve, who joined Cytokinetics in March 2020, will continue to lead clinical research with responsibility for conception, conduct, and execution of our clinical trials. As well as contributing to the expansion of our pipeline and evolution of our clinical research infrastructure as we move into a new age of artificial intelligence aided R&D.

Fady Malik: Steve, who joined Cytokinetics in March 2020, will continue to lead clinical research with responsibility for conception, conduct, and execution of our clinical trial, as well as contributing to the expansion of our pipeline and evolution of our clinical research infrastructure as we move into a new age of artificial intelligence-aided R&D.

Fady Malik: Steve, who joined Cytokinetics in March 2020, will continue to lead clinical research with responsibility for conception, conduct, and execution of our clinical trial, as well as contributing to the expansion of our pipeline and evolution of our clinical research infrastructure as we move into a new age of artificial intelligence-aided R&D.

Speaker #1: Served by his experience in treating patients with HCM and deep expertise in this disease, Steve's been an exemplary leader in helping to bring APTI Campton to patients.

Fady Malik: Certified his experience in treating patients with HCM and deep expertise in this disease. Steve's been an exemplary leader in helping to bring aficamten to patients. His insights and guidance contributed immeasurably to the approvals of MYQORZO in the US, EU, and China. Steve's also played major roles in the innovative study designs and quality of conduct of ACACIA-HCM for aficamten, AMBER-HFpEF for ulacamten, and COMET-HF for omecamtiv mecarbil. This transition represents a passing of the baton from Stuart Kupfer, who had served as Chief Medical Officer at Cytokinetics since 2020, and who contributed enormously to many of our successes in recent years, through his seasoned leadership and expert oversight of clinical research, clinical pharmacology, and drug safety. We're pleased that Stuart will remain at Cytokinetics as Senior Vice President, Clinical Development, contributing to our clinical programs and external innovation with a special focus on pharmacovigilance.

Fady Malik: Certified his experience in treating patients with HCM and deep expertise in this disease. Steve's been an exemplary leader in helping to bring aficamten to patients. His insights and guidance contributed immeasurably to the approvals of MYQORZO in the US, EU, and China. Steve's also played major roles in the innovative study designs and quality of conduct of ACACIA-HCM for aficamten, AMBER-HFpEF for ulacamten, and COMET-HF for omecamtiv mecarbil.

Speaker #1: His insights and guidance contributed immeasurably to the approvals of myCorso in the US, EU, and China. Steve's also played major roles in the innovative study designs and quality of conduct of Acacia HCM for APTI Campton, Amber Half Pepper Ulicampton, and Common HF for Omicampton MacArthur.

Speaker #1: This transition represents a passing of a baton from Stuart Kupfer, who had served as chief medical officer at Cytokinetics since 2020, and who contributed enormously to many of our successes in recent years.

Fady Malik: This transition represents a passing of the baton from Stuart Kupfer, who had served as Chief Medical Officer at Cytokinetics since 2020, and who contributed enormously to many of our successes in recent years, through his seasoned leadership and expert oversight of clinical research, clinical pharmacology, and drug safety. We're pleased that Stuart will remain at Cytokinetics as Senior Vice President, Clinical Development, contributing to our clinical programs and external innovation with a special focus on pharmacovigilance. With that, I'll hand it over to Steve.

Speaker #1: Who is seasoned leadership and expert oversight of clinical research, clinical pharmacology, and drug safety. We're pleased that Stuart will remain at Cytokinetics as senior vice president clinical development, contributing to our clinical programs and external innovation with a special focus on pharmacovigilance.

Speaker #1: And with that, I'll hand it over to Steve.

Sung Lee: With that, I'll hand it over to Steve.

Speaker #2: Thank you, Fady. So first, starting with our ongoing programs for APTI Campton, we continue to advance studies supporting broader availability worldwide. During the third quarter, we expect to complete the conduct of the Japan cohort of Acacia HCM, and for our partner Bayer, to complete the conduct of Camellia HCM, evaluating the treatment of obstructive HCM patients in Japan.

Stephen Heitner: Thank you, Fady. First, starting with our ongoing programs for aficamten, we continue to advance studies supporting broader availability worldwide. During Q3, we expect to complete the conduct of the Japan cohort of ACACIA-HCM and for our partner, Bayer, to complete the conduct of CAMELLIA-HCM, evaluating the treatment of obstructive HCM patients in Japan. We also advanced CEDAR-HCM, a study evaluating aficamten in pediatric patients with obstructive HCM. In fact, during the quarter, we completed enrollment in the adolescent cohort ahead of prior expectations. In addition to the progress for aficamten, we continue to advance the remainder of our cardiovascular pipeline during Q2. Starting with omecamtiv mecarbil, we continued conduct of COMET-HF, our confirmatory phase III clinical trial in patients with heart failure and severely reduced ejection fraction. We've now enrolled just over one-third of patients across North America, Europe, and China.

Steve Heitner: Thank you, Fady. First, starting with our ongoing programs for aficamten, we continue to advance studies supporting broader availability worldwide. During Q3, we expect to complete the conduct of the Japan cohort of ACACIA-HCM and for our partner, Bayer, to complete the conduct of CAMELLIA-HCM, evaluating the treatment of obstructive HCM patients in Japan. We also advanced CEDAR-HCM, a study evaluating aficamten in pediatric patients with obstructive HCM.

Speaker #2: We also advance Cedar HCM, our study evaluating APTI Campton in pediatric patients with obstructive HCM. In fact, during the quarter, we completed enrollment in the adolescent cohort ahead of prior expectations.

Steve Heitner: In fact, during the quarter, we completed enrollment in the adolescent cohort ahead of prior expectations. In addition to the progress for aficamten, we continue to advance the remainder of our cardiovascular pipeline during Q2. Starting with omecamtiv mecarbil, we continued conduct of COMET-HF, our confirmatory phase III clinical trial in patients with heart failure and severely reduced ejection fraction. We've now enrolled just over one-third of patients across North America, Europe, and China.

Speaker #2: In addition to the progress for APTI Campton, we continue to advance the remainder of our cardiovascular pipeline during the second quarter. Starting with Omicampton MacArthur, we continue conduct of Comet HF, our confirmatory phase three clinical trial in patients with heart failure and severely reduced ejection fraction.

Speaker #2: We've now enrolled just over one-third of patients across North America, Europe, and China. With the addition of sites from China this past quarter, more than 90% of planned sites are now activated.

Stephen Heitner: With the additional sites from China this past quarter, more than 90% of planned sites are now activated. We are encouraged that the baseline characteristics of patients with heart failure, and their severity are tracking very closely with those in the subgroup of heart failure patients from GALACTIC-HF with severely reduced ejection fraction, in whom the treatment effect appeared most concentrated, and in whom informed the design of this trial. We expect to continue enrollment through 2026. For ulacamten, we continue to enroll cohort 1 of AMBER-HFpEF, our phase II study in patients with heart failure, preserved ejection fraction, towards our expected completion of enrollment in H2 of this year. We remain focused on continuing trial conduct and generating data to help define the potential role of cardiac myosin inhibition in heart failure, preserved ejection fraction.

Steve Heitner: With the additional sites from China this past quarter, more than 90% of planned sites are now activated. We are encouraged that the baseline characteristics of patients with heart failure, and their severity are tracking very closely with those in the subgroup of heart failure patients from GALACTIC-HF with severely reduced ejection fraction, in whom the treatment effect appeared most concentrated, and in whom informed the design of this trial.

Speaker #2: We are encouraged that the baseline characteristics of patients with heart failure and their severity are tracking very closely with those in the subgroup of heart failure patients from galactic heart failure.

Speaker #2: With severely reduced ejection fraction, in whom the treatment effect appeared most concentrated, and in whom informed the design of this trial. We expect to continue enrollment through 2026.

Steve Heitner: We expect to continue enrollment through 2026. For ulacamten, we continue to enroll cohort 1 of AMBER-HFpEF, our phase II study in patients with heart failure, preserved ejection fraction, towards our expected completion of enrollment in H2 of this year. We remain focused on continuing trial conduct and generating data to help define the potential role of cardiac myosin inhibition in heart failure, preserved ejection fraction.

Speaker #2: For Ulicampton, we continue to enroll cohort one of Amber Half Pep, our phase two study in patients with heart failure with preserved ejection fraction, towards our expected completion of enrollment in the second half of this year.

Speaker #2: We remain focused on continuing trial conduct and generating data to help define the potential role of cardiac myosin inhibitions in heart failure with preserved ejection fraction.

Speaker #2: Overall, we are pleased with the continued progress across our latest stage specialty cardiology development portfolio. And look forward to important milestones over the coming quarters.

Stephen Heitner: Overall, we are pleased with the continued progress across our later-stage specialty cardiology development portfolio and look forward to important milestones over the coming quarters. With that, I'll hand over to Sung.

Steve Heitner: Overall, we are pleased with the continued progress across our later-stage specialty cardiology development portfolio and look forward to important milestones over the coming quarters. With that, I'll hand over to Sung.

Speaker #2: With that, I'll hand over to Sung Lee.

Speaker #1: Thanks, Steve. Beginning with revenue, total revenues for the second quarter were $28.6 million, compared to $66.8 million for the same period in 2025. Net product revenues of myCorso reached $25.3 million, serving as the foundational driver of our top line moving forward.

Sung Lee: Thanks, Steve Hytner. Beginning with revenue, total revenues for the Q2 were $28.6 million compared to $66.8 million for the same period in 2025. Net product revenues of MYQORZO reached $25.3 million, serving as the foundational driver of our top line moving forward. Of this amount, US net product revenues were $23 million, powered by robust demand and more than 80% of patients on paid prescriptions. Europe contributed $2.3 million in net product revenues, reflecting initial inventory purchased by distributors in Germany. Other components that contributed to total revenues in the Q2 include $3.3 million in collaboration revenue compared to $2.4 million for the same period in 2025. No licensing or milestone revenues were recorded in the Q2 of 2026, compared to $64.4 million in the Q2 of 2025, which benefited from the achievement of milestones from our collaboration agreement for aficamten in Japan with Bayer.

Sung Lee: Thanks, Steve Hytner. Beginning with revenue, total revenues for the Q2 were $28.6 million compared to $66.8 million for the same period in 2025. Net product revenues of MYQORZO reached $25.3 million, serving as the foundational driver of our top line moving forward. Of this amount, US net product revenues were $23 million, powered by robust demand and more than 80% of patients on paid prescriptions.

Speaker #1: Of this amount, US net product revenues were $23 million, powered by robust demand and more than 80% of patients on paid prescriptions. Europe contributed $2.3 million, and net product revenues reflecting initial inventory purchase by distributors in Germany.

Sung Lee: Europe contributed $2.3 million in net product revenues, reflecting initial inventory purchased by distributors in Germany. Other components that contributed to total revenues in the Q2 include $3.3 million in collaboration revenue compared to $2.4 million for the same period in 2025. No licensing or milestone revenues were recorded in the Q2 of 2026, compared to $64.4 million in the Q2 of 2025, which benefited from the achievement of milestones from our collaboration agreement for aficamten in Japan with Bayer.

Speaker #1: Other components that contributed to total revenues in the second quarter include $3.3 million in collaboration revenue, compared to $2.4 million for the same period in 2025.

Speaker #1: No licensing or milestone revenues were recorded in the second quarter of 2026, compared to $64.4 million in the second quarter of 2025, which benefited from the achievement of milestones from our collaboration agreement for APTI Campton in Japan with Bayer.

Speaker #1: Turning to operating expenses, R&D expenses for the second quarter were $97.8 million, compared to $110.1 million for the same period in 2025. The decrease was primarily due to higher clinical trial activity, supply chain costs, and medical affairs activities in 2025, partially offset by higher personnel related costs in 2026.

Sung Lee: Turning to operating expenses, R&D expenses for the Q2 were $97.8 million compared to $110.1 million for the same period in 2025. The decrease was primarily due to higher clinical trial activity, supply chain costs, and medical affairs activities in 2025, partially offset by higher personnel-related costs in 2026. SG&A expenses for the Q2 were $104.4 million compared to $65.7 million for the same period in 2025. The increase was primarily due to commercial launch costs for MYQORZO, the US sales force, and higher non-sales personnel-related costs, including stock-based compensation. Cost of goods sold for the Q2 of 2026 was $2.7 million, driven almost entirely by a non-routine charge related to drug supply optimization.

Sung Lee: Turning to operating expenses, R&D expenses for the Q2 were $97.8 million compared to $110.1 million for the same period in 2025. The decrease was primarily due to higher clinical trial activity, supply chain costs, and medical affairs activities in 2025, partially offset by higher personnel-related costs in 2026. SG&A expenses for the Q2 were $104.4 million compared to $65.7 million for the same period in 2025.

Speaker #1: SG&A expenses for the second quarter were $104.4 million compared to $65.7 million for the same period in 2025. The increase was primarily due to commercial launch costs for myCorso, the US sales force, and higher non-sales personnel related costs, including stock-based compensation.

Sung Lee: The increase was primarily due to commercial launch costs for MYQORZO, the US sales force, and higher non-sales personnel-related costs, including stock-based compensation. Cost of goods sold for the Q2 of 2026 was $2.7 million, driven almost entirely by a non-routine charge related to drug supply optimization.

Speaker #1: Cost of goods sold for the second quarter of 2026 was $2.7 million, driven almost entirely by a non-routine charge related to drug supply optimization.

Speaker #1: Collaboration cost of revenues for the second quarter of 2026 was $2.9 million, compared to $2.4 million for the same period in 2025, reflecting primarily partner cost reimbursements.

Sung Lee: Collaboration cost of revenues for the Q2 of 2026 was $2.9 million compared to $2.4 million for the same period in 2025, reflecting primarily partner cost reimbursement. Net loss for the Q2 of 2026 was $198.8 million, or $1.50 per share, compared to a net loss of $134.4 million or $1.12 per share for the same period in 2025. Turning to the balance sheet, we ended the Q2 with approximately $1.7 billion in cash and investments, compared to $1.1 billion at the end of the Q1 of 2026. The increase in cash and investments in the Q2 was primarily driven by our May public offering, generating approximately $760 million in net proceeds.

Sung Lee: Collaboration cost of revenues for the Q2 of 2026 was $2.9 million compared to $2.4 million for the same period in 2025, reflecting primarily partner cost reimbursement. Net loss for the Q2 of 2026 was $198.8 million, or $1.50 per share, compared to a net loss of $134.4 million or $1.12 per share for the same period in 2025.

Speaker #1: Net logs for the second quarter of 2026 was $198.8 million, or $1.50 per share, compared to a net loss of $134.4 million or $1.12 per share, for the same period in 2025.

Speaker #1: Turning to the balance sheet, we ended the second quarter with approximately $1.7 billion in cash and investments, compared to $1.1 billion at the end of the first quarter of 2026.

Sung Lee: Turning to the balance sheet, we ended the Q2 with approximately $1.7 billion in cash and investments, compared to $1.1 billion at the end of the Q1 of 2026. The increase in cash and investments in the Q2 was primarily driven by our May public offering, generating approximately $760 million in net proceeds.

Speaker #1: The increase in cash and investments in the second quarter was primarily driven by our May public offering, generating approximately $760 million in net proceeds.

Speaker #1: Turning to financial guidance, we are updating full-year 2026 GAAP combined R&D and SG&A expense to a range of $860 million to $890 million, from the previous range of $830 million to $870 million.

Sung Lee: Turning to financial guidance, we are updating full year 2026 GAAP combined R&D and SG&A expense to a range of $860 million to $890 million from the previous range of $830 million to $870 million. Stock-based compensation included in the GAAP combined R&D and SG&A expense is being adjusted to a range of $130 million to $140 million, up from the previous range of $120 million to $130 million. Excluding stock-based compensation from the updated GAAP combined R&D and SG&A expense results in a range of $720 million to $760 million. This increase in guidance is primarily driven by commercial readiness investments prompted by the positive results from ACACIA-HCM to support the potential 2027 launch of MYQORZO in NHCM. With that, I'll hand it back to Robert.

Sung Lee: Turning to financial guidance, we are updating full year 2026 GAAP combined R&D and SG&A expense to a range of $860 million to $890 million from the previous range of $830 million to $870 million. Stock-based compensation included in the GAAP combined R&D and SG&A expense is being adjusted to a range of $130 million to $140 million, up from the previous range of $120 million to $130 million.

Speaker #1: Stock-based compensation included in the GAAP combined R&D and SG&A expense is being adjusted to a range of $130 million to $140 million, up from the previous range of $120 million to $130 million.

Speaker #1: Excluding stock-based compensation from the updated gap combined R&D and SG&A expense, results in a range of $720 million to $760 million. This increase in guidance is primarily driven by commercial readiness investments prompted by the positive results from Acacia HCM to support the potential 2027 launch of myCorso, an NHCM.

Sung Lee: Excluding stock-based compensation from the updated GAAP combined R&D and SG&A expense results in a range of $720 million to $760 million. This increase in guidance is primarily driven by commercial readiness investments prompted by the positive results from ACACIA-HCM to support the potential 2027 launch of MYQORZO in NHCM. With that, I'll hand it back to Robert.

Speaker #1: With that, I'll hand it back to Robert.

Speaker #2: Thank you, Sung. As we reflect on the first half of 2026, I believe the progress that we've made demonstrates the strength of our execution.

Robert Blum: Thank you, Sung. As we reflect on H1 2026, I believe the progress that we've made demonstrates the strength of our execution and our strategic positioning as a maturing global growth enterprise. In less than six months of our commercial launch, we've seen encouraging demand for MYQORZO, growing physician adoption, and expanding patient access. The breadth of prescribing, increasing depth of use amongst physicians, and growth in patient volume all provide evidence that our launch is gaining momentum. We also executed a successful launch in our first European market, and while we're early in our commercial journey, the trajectory we're seeing reinforces our belief that MYQORZO has the potential to become the CMI of choice in oHCM. Our near-term priorities for aficamten are clear. In oHCM, firstly, executing successful global launches for MYQORZO and pursuing additional approvals across Europe.

Robert Blum: Thank you, Sung. As we reflect on H1 2026, I believe the progress that we've made demonstrates the strength of our execution and our strategic positioning as a maturing global growth enterprise. In less than six months of our commercial launch, we've seen encouraging demand for MYQORZO, growing physician adoption, and expanding patient access. The breadth of prescribing, increasing depth of use amongst physicians, and growth in patient volume all provide evidence that our launch is gaining momentum.

Speaker #2: And our strategic positioning as a maturing global growth enterprise. In less than six months of our commercial launch, we've seen encouraging demand for myCorso, growing physician adoption, and expanding patient access.

Speaker #2: The breadth of prescribing, increasing depth of use amongst physicians, and growth in patient volume all provide evidence that our launch is gaining momentum. We also executed a successful launch in our first European market.

Robert Blum: We also executed a successful launch in our first European market, and while we're early in our commercial journey, the trajectory we're seeing reinforces our belief that MYQORZO has the potential to become the CMI of choice in oHCM. Our near-term priorities for aficamten are clear. In oHCM, firstly, executing successful global launches for MYQORZO and pursuing additional approvals across Europe.

Speaker #2: And while we're early in our commercial journey, the trajectory we're seeing reinforces our belief that myCorso has the potential to become the CMI of choice in OHCM.

Speaker #2: Our near-term priorities for APTI Campton are clear. In OHCM, firstly, executing successful global launches for myCorso and pursuing additional approvals across Europe. In NHCM, presenting the primary results from Acacia HCM at ESC and preparing and submitting an SNDA to FDA later this year, as well as planning for the commercialization in NHCM.

Robert Blum: In NHCM, presenting the primary results from ACACIA-HCM at ESC and preparing and submitting an sNDA to FDA later this year, as well as planning for the commercialization in NHCM. Beyond Europe, regulatory reviews for aficamten also remain active in multiple geographies, including Canada, Hong Kong, and Taiwan. In parallel, we continue to evaluate opportunities to broaden global access through potential partners in additional regions outside of North America, Europe, and Asia, where we believe MYQORZO may address meaningful unmet need. Building our specialty cardiology franchise also relies on the promise of both omecamtiv mecarbil and ulacamten, which we're pleased are progressing well in respective later-stage trials. As we look ahead, I believe our strategic positioning has never been stronger.

Robert Blum: In NHCM, presenting the primary results from ACACIA-HCM at ESC and preparing and submitting an sNDA to FDA later this year, as well as planning for the commercialization in NHCM. Beyond Europe, regulatory reviews for aficamten also remain active in multiple geographies, including Canada, Hong Kong, and Taiwan.

Speaker #2: Beyond Europe, regulatory reviews for APTI Campton also remain active in multiple geographies, including Canada, Hong Kong, and Taiwan. In parallel, we continue to evaluate opportunities to broaden global access through potential partners, in additional regions outside of North America, Europe, and Asia, where we believe myCorso may address meaningful unmet need.

Robert Blum: In parallel, we continue to evaluate opportunities to broaden global access through potential partners in additional regions outside of North America, Europe, and Asia, where we believe MYQORZO may address meaningful unmet need. Building our specialty cardiology franchise also relies on the promise of both omecamtiv mecarbil and ulacamten, which we're pleased are progressing well in respective later-stage trials. As we look ahead, I believe our strategic positioning has never been stronger.

Speaker #2: Building our specialty cardiology franchise also relies on the promise of both OMI Campton Macarbo and Ulah Campton, which were pleased or progressing well in respective later stage trials.

Speaker #2: As we look ahead, I believe our strategic positioning has never been stronger or entering this next phase of growth with a strong balance sheet that provides financial flexibility to support the global commercialization of myCorso and continuing investing across our pipeline to pursue opportunities that can enhance longer-term shareholder value.

Robert Blum: We're entering this next phase of growth with a strong balance sheet that provides financial flexibility to support the global commercialization of MYQORZO and continuing investing across our pipeline to pursue opportunities that can enhance longer-term shareholder value. Together with our growing commercial presence, expanding clinical evidence base, and advancing pipeline, we believe we're well-positioned to create meaningful value for patients and shareholders in the years ahead. Now, I'll recap our 2026 milestones. For aficamten, we expect to submit a supplemental NDA in NHCM in Q4 later this year, and we potentially will receive FDA approval of the sNDA for MAPLE-HCM also in Q4 later this year. We expect to prepare to launch aficamten in the UK later in Q4, continue conduct of the adolescent cohort of CEDAR-HCM throughout the year, and potentially receive approval from Health Canada in H2 2026.

Robert Blum: We're entering this next phase of growth with a strong balance sheet that provides financial flexibility to support the global commercialization of MYQORZO and continuing investing across our pipeline to pursue opportunities that can enhance longer-term shareholder value. Together with our growing commercial presence, expanding clinical evidence base, and advancing pipeline, we believe we're well-positioned to create meaningful value for patients and shareholders in the years ahead.

Speaker #2: Together with our growing commercial presence, expanding clinical evidence base, and advancing pipeline, we believe we're well positioned to create meaningful value for patients and shareholders in the years ahead.

Speaker #2: Now, I'll recap our 2026 milestones. For APTI Campton, we expect to submit a supplemental NDA in NHCM in Q4 later this year. And we potentially will receive FDA approval of the SNDA for Maple HCM also in Q4 later this year.

Robert Blum: Now, I'll recap our 2026 milestones. For aficamten, we expect to submit a supplemental NDA in NHCM in Q4 later this year, and we potentially will receive FDA approval of the sNDA for MAPLE-HCM also in Q4 later this year. We expect to prepare to launch aficamten in the UK later in Q4, continue conduct of the adolescent cohort of CEDAR-HCM throughout the year, and potentially receive approval from Health Canada in H2 2026.

Speaker #2: We expect to prepare to launch APTI Campton in the UK later in Q4, continue conduct of the adolescent cohort of Cedar HCM throughout the year, and potentially receive approval from Health Canada in the second half of 2026.

Speaker #2: For OMI Campton Macarbo, we expect to continue patient enrollment and the conduct of Comet HCF through this year. For Ulah Campton, we expect to complete patient enrollment in cohort one of Amber Hep Pep in the second half of this year.

Robert Blum: For omecamtiv mecarbil, we expect to continue patient enrollment and the conduct of COMET-HF through this year. For ulacamten, we expect to complete patient enrollment in cohort 1 of AMBER-HFpEF in H2 this year. For CK-089, we expect to continue the second phase I study. Finally, for preclinical development and ongoing research, we expect to continue those activities directed to additional muscle biology-focused programs. Operator, with that, we can now open up the call to questions, please.

Robert Blum: For omecamtiv mecarbil, we expect to continue patient enrollment and the conduct of COMET-HF through this year. For ulacamten, we expect to complete patient enrollment in cohort 1 of AMBER-HFpEF in H2 this year. For CK-089, we expect to continue the second phase I study. Finally, for preclinical development and ongoing research, we expect to continue those activities directed to additional muscle biology-focused programs. Operator, with that, we can now open up the call to questions, please.

Speaker #2: And for CK089, we expect to continue the second phase one study ongoing research, we expect to continue those activities directed to additional muscle biology-focused programs.

Speaker #2: An operator with that, we can now open up the call to questions, please.

Speaker #3: Thank you. We will now begin the question and answer session. We will allow for one question per participant. If you would like to ask a question, please press star one to raise your hand.

Operator: Thank you. We will now begin the question and answer session. We will allow for one question per participant. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Your first question comes from the line of Salim Syed with Mizuho. Salim, your line is open.

Operator: Thank you. We will now begin the question and answer session. We will allow for one question per participant. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Your first question comes from the line of Salim Syed with Mizuho. Salim, your line is open.

Speaker #3: To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality.

Speaker #3: If you are muted locally, please remember to unmute your device. Your first question comes from the line of Salim Syed with Mizuho. Salim, your line, please open.

Speaker #1: Great. Good afternoon, guys, and thanks for the question and congrats on the great number. Robert and Andrew, maybe just one from us on the dispensed versus prescribed we're certainly getting a lot of emails just on the clarification here.

Salim Syed: Great. Good afternoon, guys. Thanks for the question, and congrats on the great number. Robert and Andrew, maybe just one from us on the dispensed versus prescribed. We're certainly getting a lot of emails just on the clarification here. Could you, just so we have the apples to apples on the Rx. I think you said it was 400 dispensed versus the 680 in the Q1, and then 1,500 dispensed this quarter. What's the Rx this quarter? If you could provide that. Is the ratio of 59% consistent between the two quarters, if you don't want to get too granular? Thanks so much.

Salim Syed: Great. Good afternoon, guys. Thanks for the question, and congrats on the great number. Robert and Andrew, maybe just one from us on the dispensed versus prescribed. We're certainly getting a lot of emails just on the clarification here. Could you, just so we have the apples to apples on the Rx. I think you said it was 400 dispensed versus the 680 in the Q1, and then 1,500 dispensed this quarter. What's the Rx this quarter? If you could provide that. Is the ratio of 59% consistent between the two quarters, if you don't want to get too granular? Thanks so much.

Speaker #1: Could you just so we have the apples to apples on the RX? So I think you said it was 400 dispensed 400 dispensed versus the 680 and the 1Q, and then 1,500 dispensed this quarter.

Speaker #1: What's the RX this quarter? If you could provide that. And is the ratio of 59% consistent between the two quarters, if you don't want to get too granular?

Speaker #1: Thanks so much.

Speaker #2: Yes. I'll turn that over to Andrew to address. But obviously, it's the dispensing that drives the revenue. So we thought it important to align to that number.

Robert Blum: Yes. I'll turn that over to Andrew to address. Obviously it's the dispensing that drives the revenue, so we thought it important to align to that number. Andrew, could you address the specific prescriptions and dispensing in Q2?

Robert Blum: Yes. I'll turn that over to Andrew to address. Obviously it's the dispensing that drives the revenue, so we thought it important to align to that number. Andrew, could you address the specific prescriptions and dispensing in Q2?

Speaker #2: But Andrew, could you address the specific prescriptions and dispensing in Q2?

Speaker #3: Sure. Yeah. Thanks for the question, Salim. Happy to clarify. To your right, 680 to 400 in Q1 to around 2,000 to 1,500 in Q2.

Andrew Callos: Sure. Yeah. Thanks for the question, Salim. Happy to clarify. You're right, 680 to 400 in Q1 to around 2,000 to 1,500 in Q2. Launch to date overall. That difference of pending patients. We described patients in the process. Once a prescription is sent in, that's really the underlying demand. There has not been a change. Actually, there's a growth in underlying demand as you saw from the market share for new-to-brand that we reported. There is a process. A REMS enrollment has to occur, a prescription has to occur, signatures both on physician and patient side, benefit investigation, oftentimes prior auth. There's a process that takes several weeks. We're getting about 100 plus prescriptions per week. The majority of the difference is that pending patient in process of getting a prescription filled and dispensed.

Andrew Callos: Sure. Yeah. Thanks for the question, Salim. Happy to clarify. You're right, 680 to 400 in Q1 to around 2,000 to 1,500 in Q2. Launch to date overall. That difference of pending patients. We described patients in the process. Once a prescription is sent in, that's really the underlying demand. There has not been a change.

Speaker #3: Launch to date overall. That difference of pending patients we described patients in the process. Once a prescription is sent in, I mean, that's really the underlying demand.

Speaker #3: And there has not been a change actually. There's a growth in underlying demand as you saw from the market share for new to brand that we reported.

Andrew Callos: Actually, there's a growth in underlying demand as you saw from the market share for new-to-brand that we reported. There is a process. A REMS enrollment has to occur, a prescription has to occur, signatures both on physician and patient side, benefit investigation, oftentimes prior auth. There's a process that takes several weeks.

Speaker #3: But there is a process. There's a REMS enrollment has to occur, a prescription has to occur, signatures growth on physician and patient side, benefit investigation oftentimes prior auth.

Speaker #3: So there's a process that takes several weeks. We're getting about 100 plus prescriptions per week so the majority of the difference is that pending patient in process of getting a prescription filled and dispensed.

Andrew Callos: We're getting about 100 plus prescriptions per week. The majority of the difference is that pending patient in process of getting a prescription filled and dispensed. There is a small mid-single digit of prescriptions that do get canceled. The vast majority are in process and will wind up as a dispense, hopefully that answers your question.

Speaker #3: There is a kind of a small mid-single digit of prescriptions that do get canceled. But the vast majority are in process and will wind up as a dispense.

Andrew Callos: There is a small mid-single digit of prescriptions that do get canceled. The vast majority are in process and will wind up as a dispense, hopefully that answers your question.

Speaker #3: Hopefully, that answers your question.

Speaker #1: Okay. So about 2,000.

Salim Syed: Okay. About 2,000.

Salim Syed: Okay. About 2,000.

Speaker #3: Yep. You got it.

Andrew Callos: Yep. You got it.

Andrew Callos: Yep. You got it.

Speaker #1: Okay. Got it. Thanks so much for the clarification.

Salim Syed: Okay. Got it. Thanks so much for the clarification.

Salim Syed: Okay. Got it. Thanks so much for the clarification.

Speaker #2: Thank you, Salim.

Robert Blum: Thank you, Salim.

Robert Blum: Thank you, Salim.

Speaker #3: Our next question comes from the line of Rowana Ruiz with Leerink Partners. Your line is open, please go ahead.

Operator: Our next question comes from the line of Roanna Ruiz with Leerink Partners. Your line is open.

Operator: Our next question comes from the line of Roanna Ruiz with Leerink Partners. Your line is open.

Speaker #4: Hi. Afternoon, everyone. So I was curious regarding the different metrics that you're tracking for myCorso's US launch, just a big picture. Are there any that seem to be accelerating more than others into on the what you can see in terms of number of switches versus new patient starts that proportion holding from last quarter?

Roanna Ruiz: Hi. Afternoon, everyone. I was curious, regarding the different metrics that you're tracking for MYQORZO's US launch, just the big picture, are there any that seem to be accelerating more than others into the quarter? Could you comment on what you can see in terms of number of switches versus new patient starts, that proportion holding from last quarter? Are you seeing some changes there?

Roanna Ruiz: Hi. Afternoon, everyone. I was curious, regarding the different metrics that you're tracking for MYQORZO's US launch, just the big picture, are there any that seem to be accelerating more than others into the quarter? Could you comment on what you can see in terms of number of switches versus new patient starts, that proportion holding from last quarter? Are you seeing some changes there?

Speaker #4: Are you seeing some changes there?

Speaker #2: Sure. So maybe I'll turn that also to Andrew, please.

Robert Blum: Sure. Maybe I'll turn that also to Andrew, please.

Robert Blum: Sure. Maybe I'll turn that also to Andrew, please.

Speaker #3: Sure. Thanks for the question. So we are seeing a couple changes. One, the higher percentage of paid-for prescriptions which is encouraging. Around the same in terms of how long it's taking that prescription paid we're seeing acceleration in that low volume.

Andrew Callos: Sure. Thanks for the question. We are seeing a couple changes. One, the higher percentage of paid-for prescriptions, which is encouraging. Around the same in terms of how long it's taking to get that prescription paid. We are seeing acceleration in that low volume to first-time ever CMI prescribers from a switching point of view. Both of those certainly speak to breadth of prescribing. Switching, we reported very low single digit. We are actually seeing probably in the 5% to 7% of our overall dispenses are from switching. The switching has increased slightly, not dramatically and not a major driver.

Andrew Callos: Sure. Thanks for the question. We are seeing a couple changes. One, the higher percentage of paid-for prescriptions, which is encouraging. Around the same in terms of how long it's taking to get that prescription paid. We are seeing acceleration in that low volume to first-time ever CMI prescribers from a switching point of view. Both of those certainly speak to breadth of prescribing. Switching, we reported very low single digit. We are actually seeing probably in the 5% to 7% of our overall dispenses are from switching. The switching has increased slightly, not dramatically and not a major driver.

Speaker #3: To first-time ever CMI prescribers, from a switching point of view and both of those certainly speak to breadth of prescribing. Switching, we reported very kind of low single digit.

Speaker #3: We are actually seeing probably in the 5 to 7 percent of our overall dispenses are from switching. The switching has increased slightly, but not dramatically and not a major driver.

Speaker #3: Thanks for the question. Our next question comes from the line of Carter Gould with Canterfetch Gerald. Your line, please open.

Roanna Ruiz: Thanks for the question.

Robert Blum: Thanks for the question.

Operator: Our next question comes from the line of Carter Gould with Cantor Fitzgerald. Your line is open.

Operator: Our next question comes from the line of Carter Gould with Cantor Fitzgerald. Your line is open.

Robert Blum: Hey, Carter.

Robert Blum: Hey, Carter.

Carter Gould: Great. Good afternoon. Hey, Robert. Good afternoon. Thanks for taking the questions. Doing a bunch of math on the fly here, but it would seem to suggest that the overall class adds per month or per week are only up modestly, and what you're seeing so far is primarily share capture versus growing the pie. Is that a fair characterization? Separately, I guess a clarification question, was there any impact from stocking in that $23 million US figure? Thank you.

Carter Gould: Great. Good afternoon. Hey, Robert. Good afternoon. Thanks for taking the questions. Doing a bunch of math on the fly here, but it would seem to suggest that the overall class adds per month or per week are only up modestly, and what you're seeing so far is primarily share capture versus growing the pie. Is that a fair characterization? Separately, I guess a clarification question, was there any impact from stocking in that $23 million US figure? Thank you.

Speaker #1: Great. Good afternoon. Hey, Robert. Good afternoon. Thanks for taking the questions. Doing a bunch of math on the fly here, but it would seem to suggest that the overall class sort of ads per month or per week are only sort of up modestly.

Speaker #1: And what you're seeing so far is primarily share capture versus growing the pie. Is that sort of a fair characterization? And separately, I guess a clarification question.

Speaker #1: Was there any impact from stop stocking in that 23 million dollar US figure? Thank you.

Speaker #2: So Andrew, again, I'll turn to you, please.

Robert Blum: Andrew, again, I'll turn to you, please.

Robert Blum: Andrew, again, I'll turn to you, please.

Speaker #3: Sure. So we are actually seeing an increase in growth. I showed you the new to brand prescription growth overall. I think last year we were seeing at least in syndicated data about 2,000 new prescriptions per quarter.

Andrew Callos: Sure. We are actually seeing an increase in growth. I showed you the new-to-brand prescription growth overall. I think last year we were seeing, at least in syndicated data, about 2,000 new prescriptions per quarter. I think in the first quarter, the number was probably around 2,500. In the second quarter, it's starting to approach 3,000. You're seeing a growth in terms of new patients entering the market. There really hasn't been a change in compliance and persistency overall. You're seeing an increase in patients dispensed. I'll hand the other question over to Sung around stocking relative to revenue.

Andrew Callos: Sure. We are actually seeing an increase in growth. I showed you the new-to-brand prescription growth overall. I think last year we were seeing, at least in syndicated data, about 2,000 new prescriptions per quarter. I think in the first quarter, the number was probably around 2,500. In the second quarter, it's starting to approach 3,000. You're seeing a growth in terms of new patients entering the market. There really hasn't been a change in compliance and persistency overall. You're seeing an increase in patients dispensed. I'll hand the other question over to Sung around stocking relative to revenue.

Speaker #3: I think in the first quarter, the number was probably around 2,500. In the second quarter, it's starting to approach 3,000. So you're seeing a growth in terms of new patients, entering the market, and there really hasn't been a change in kind of compliance and persistency overall.

Speaker #3: So you're seeing an increase in patients dispensed. And another question over to Sung around stocking relative to revenue.

Speaker #5: Yeah. So thanks, Carter. So as demand increases, our distributors would carry higher inventory, but that inventory is commensurate with the demand. So this quarter was demand less.

Sung Lee: Yeah. Thanks, Carter. As demand increases, our distributors would carry higher inventory, but that inventory is commensurate with the demand. This quarter was demand-led.

Sung Lee: Yeah. Thanks, Carter. As demand increases, our distributors would carry higher inventory, but that inventory is commensurate with the demand. This quarter was demand-led.

Speaker #1: Thank you.

Carter Gould: Thank you.

Carter Gould: Thank you.

Speaker #2: Thank you, Carter.

Robert Blum: Thank you, Carter.

Robert Blum: Thank you, Carter.

Speaker #3: Our next question comes from the line of Ash Verma with UBS. Your line, please open.

Operator: Our next question comes from the line of Ash Verma with UBS. Your line is open.

Operator: Our next question comes from the line of Ash Verma with UBS. Your line is open.

Speaker #6: Hey, guys. Thanks for taking my question. So yeah, I have kind of like a similar question, just a prescription versus dispense. So I know when you provided the first quarter update, you mentioned about the April prescription.

Ash Verma: Hey, guys. Thanks for taking my question. Yeah, I have a similar question, just the prescriptions with the dispense. I know when you provided the Q1 update, you mentioned about the April prescription, and if I take that 420 number and apply the 60%, I get to 250 dispensed during April. versus when you did it for the full quarter, it's 1,500. One month had 250, and then for the full quarter, you have 1,500. As you're thinking about month-over-month, are you seeing more of a growth acceleration at this point? Anything that you can share about how July has shaped out to be? Thanks.

Ash Verma: Hey, guys. Thanks for taking my question. Yeah, I have a similar question, just the prescriptions with the dispense. I know when you provided the Q1 update, you mentioned about the April prescription, and if I take that 420 number and apply the 60%, I get to 250 dispensed during April. versus when you did it for the full quarter, it's 1,500. One month had 250, and then for the full quarter, you have 1,500. As you're thinking about month-over-month, are you seeing more of a growth acceleration at this point? Anything that you can share about how July has shaped out to be? Thanks.

Speaker #6: And if I take that 420 number and apply this 60%, I get to 250 dispensed during April. Versus when you did it for the full quarter, it's like 1,500.

Speaker #6: So one month had 250, and then for the full quarter, you have 1,500. So as you’re thinking about month-over-month, are you seeing more of a growth acceleration at this point?

Speaker #6: And anything that you can share about how July shaped out to be? Thanks.

Speaker #5: So we'll resist the temptation to talk about July, but Andrew, could you speak to the second quarter?

Robert Blum: We will resist the temptation to talk about July, but Andrew, could you speak to Q2?

Robert Blum: We will resist the temptation to talk about July, but Andrew, could you speak to Q2?

Speaker #3: Sure. So you can see from the ratios, we do see an increase in dispense. I would expect dispenses to level out once managed care and access level outs.

Andrew Callos: Sure. You can see from the ratios, we do see an increase in dispense. I would expect dispenses to level out once managed care and access level out. Oftentimes, that timeframe of a pending patient, and the REMS certainly adds to it because of certifications needed. A pending patient often stays in pending longer because of the benefits investigation and a prior auth process. We would look to shrink that timeframe down over time, but I would not anticipate that in the near term.

Andrew Callos: Sure. You can see from the ratios, we do see an increase in dispense. I would expect dispenses to level out once managed care and access level out. Oftentimes, that timeframe of a pending patient, and the REMS certainly adds to it because of certifications needed. A pending patient often stays in pending longer because of the benefits investigation and a prior auth process. We would look to shrink that timeframe down over time, but I would not anticipate that in the near term.

Speaker #3: Oftentimes, that timeframe for a pending patient—and the REMS certainly adds to it because of certifications needed—but a patient often stays in pending longer because of the benefits investigation and prior auth process.

Speaker #3: So we would look to shrink that timeframe down over time, but I would not anticipate that in the near term. Thanks for the question.

Robert Blum: Thanks for the question.

Robert Blum: Thanks for the question.

Speaker #3: Our next question comes from the line of Tess Romero with JP Morgan. Tess, your line, please open.

Operator: Our next question comes from the line of Tess Romero with J.P. Morgan. Tess, your line is open.

Operator: Our next question comes from the line of Tess Romero with J.P. Morgan. Tess, your line is open.

Speaker #7: Hi, Robert and team. Hope you are all well and thanks so much for taking our question. So taking a step back, as you think about ESC here coming up in a few weeks, what do you believe will be better understood by physicians and investors on the other side of the conference?

Tessa Romero: Hi, Robert and team. Hope you are all well, and thanks so much for taking our question. Taking a step back as you think about ESC here coming up in a few weeks, what do you believe will be better understood by physicians and investors on the other side of the conference? Secondly, just to double-click here, you talked about reaching 50% new-to-brand share by end of the year, if not sooner, for MYQORZO. With that in mind, where do you sit now? Thank you so much.

Tessa Romero: Hi, Robert and team. Hope you are all well, and thanks so much for taking our question. Taking a step back as you think about ESC here coming up in a few weeks, what do you believe will be better understood by physicians and investors on the other side of the conference? Secondly, just to double-click here, you talked about reaching 50% new-to-brand share by end of the year, if not sooner, for MYQORZO. With that in mind, where do you sit now? Thank you so much.

Speaker #7: And then secondly, just to double-click here, you talked about reaching 50% new to brand share by end of the year if not sooner for myCorso.

Speaker #7: With that in mind, where do you sit now? Thank you so much.

Speaker #5: So let's take the first part of your question regarding ESC. What might be elaborated from with regard to what has already been disclosed in our top-line press release?

Robert Blum: Let's take the first part of your question regarding ESC, what might be elaborated from with regard to what has already been disclosed in our top-line press release. Firstly, we've been very clear that we believe that when we actually present the fuller data, that investors will better understand what we've meant by words like consistent and robust as we now can speak to magnitudes of change across all endpoints, including secondary endpoints, and how we believe that tells a very consistent, robust story of efficacy measured by those various endpoints. Maybe I'll ask Fady and Steve if they want to speak more to that before we address your second question, which relates to a proportion of new scripts.

Robert Blum: Let's take the first part of your question regarding ESC, what might be elaborated from with regard to what has already been disclosed in our top-line press release. Firstly, we've been very clear that we believe that when we actually present the fuller data, that investors will better understand what we've meant by words like consistent and robust as we now can speak to magnitudes of change across all endpoints, including secondary endpoints, and how we believe that tells a very consistent, robust story of efficacy measured by those various endpoints. Maybe I'll ask Fady and Steve if they want to speak more to that before we address your second question, which relates to a proportion of new scripts.

Speaker #5: Firstly, we've been very clear that we believe that when we actually present the fuller data, that investors will better understand what we've meant by words like consistent and robust as we now can speak to magnitudes of change across all endpoints, including secondary endpoints and how we believe that tells a very consistent, robust story of efficacy measured by those various endpoints.

Speaker #5: Maybe I'll ask Fady and Steve if they want to speak more to that before we address your second question, which relates to the proportion of new scripts.

Speaker #2: Hi, Tess. So we have both the top-line data, which kind of goes to the endpoints delineated in the SAP. But those are going to be put into both clinical and mechanistic context.

Stephen Heitner: Hi, Tess. We have both the top-line data, which kind of goes through the endpoints delineated in the SAP, but those are going to be put into both clinical and mechanistic context. The clinical context will be deliberated by Dr. Masri in his hotline presentation on Friday. On the Saturday, you'll see that there is the echo analysis that's being done by Dr. Hegde where we'll be talking about what the mechanism by which these clinical benefits are being enjoyed by patients. I think that that's going to be very elucidating to scientists and patients, hopefully, moving forward.

Steve Heitner: Hi, Tess. We have both the top-line data, which kind of goes through the endpoints delineated in the SAP, but those are going to be put into both clinical and mechanistic context. The clinical context will be deliberated by Dr. Masri in his hotline presentation on Friday. On the Saturday, you'll see that there is the echo analysis that's being done by Dr. Hegde where we'll be talking about what the mechanism by which these clinical benefits are being enjoyed by patients. I think that that's going to be very elucidating to scientists and patients, hopefully, moving forward.

Speaker #2: So the clinical context, we'll be deliberated by Dr. Masry and his hotline presentation on Friday. And then on the Saturday, you'll see that there is the echo analysis that's being done by Dr. Hegde where we'll be talking about what the mechanism by which these clinical benefits are being enjoyed by patients.

Speaker #2: And I think that that's going to be very elucidating to scientists and patients, hopefully, moving forward.

Speaker #5: So I do think that as these data will be fully presented, we'll be able to speak much more completely about the effects how they were observed across time as well as ultimately across endpoints that measure both function and quality of life.

Robert Blum: I do think that as these data will be fully presented, we'll be able to speak much more completely about the effects, how they were observed across time, as well as ultimately across endpoints that measure both function and quality of life. With regard to your second question, let's turn to Andrew. I think you may have already addressed it in part by speaking to over 40% proportion of new scripts coming out of Q2, but maybe, Andrew, if there's anything more you want to elaborate.

Robert Blum: I do think that as these data will be fully presented, we'll be able to speak much more completely about the effects, how they were observed across time, as well as ultimately across endpoints that measure both function and quality of life. With regard to your second question, let's turn to Andrew. I think you may have already addressed it in part by speaking to over 40% proportion of new scripts coming out of Q2, but maybe, Andrew, if there's anything more you want to elaborate.

Speaker #5: With regard to your second question, let's turn to Andrew. I think he may have already addressed it in part by speaking to the over 40% proportion of new scripts coming out of the second quarter, but maybe, Andrew, if there's anything more you want to elaborate on.

Speaker #3: Yeah. I mean, that's the number we're reporting at the end of Q2 as an exit share, meaning our share in the month of June was over 40% new to brand share.

Andrew Callos: Yeah, that's the number we're reporting at the end of Q2 as an exit share, meaning our share in the month of June was over 40% new-to-brand share. We're not going to report July. We'll report the Q3 during that call.

Andrew Callos: Yeah, that's the number we're reporting at the end of Q2 as an exit share, meaning our share in the month of June was over 40% new-to-brand share. We're not going to report July. We'll report the Q3 during that call.

Speaker #3: So we're not going to report July; we'll report the third quarter during that call.

Speaker #2: You know, Tess, to the point, if not sooner, the trends are demonstrating that we are seeing a higher proportion of new scripts to myCorso than might have been expected.

Robert Blum: Tess, to the point, if not sooner, the trends are demonstrating that we are seeing a higher proportion of new scripts to MYQORZO than might have been expected. When we talk about exceeding expectations, we are coming out of the gate very strongly with respect to new scripts. Knowing that some of that could be a transient effect, I think we're going to be still conservative with respect to timing on when we might expect majority share. Certainly, it's moving very swiftly in that direction.

Robert Blum: Tess, to the point, if not sooner, the trends are demonstrating that we are seeing a higher proportion of new scripts to MYQORZO than might have been expected. When we talk about exceeding expectations, we are coming out of the gate very strongly with respect to new scripts. Knowing that some of that could be a transient effect, I think we're going to be still conservative with respect to timing on when we might expect majority share. Certainly, it's moving very swiftly in that direction.

Speaker #2: And when we talk about exceeding expectations, we are coming out of the gate very strongly with respect to new scripts. Knowing that some of that could be a transient effect, I think we're going to be still conservative with respect to timing on when we might expect majority share.

Speaker #2: But certainly, it's moving very swiftly in that direction.

Speaker #7: Thank you. See you soon.

Tessa Romero: Thank you. See you soon.

Tessa Romero: Thank you. See you soon.

Speaker #5: Thank you.

Robert Blum: Thank you.

Robert Blum: Thank you.

Speaker #2: Thank you.

Andrew Callos: Thank you.

Andrew Callos: Thank you.

Speaker #3: Thank you. Our next question comes from the line of Akash Tiwari with Jefferies. Your line, please open.

Stephen Heitner: Thank you.

Steve Heitner: Thank you.

Operator: Our next question comes from the line of Akash Tewari with Jefferies. Your line is open.

Operator: Our next question comes from the line of Akash Tewari with Jefferies. Your line is open.

Speaker #5: Hey, Akash.

Robert Blum: Hey, Akash.

Robert Blum: Hey, Akash.

[Analyst] (Jefferies): Hey. This is Manoj. Hey. Sorry. This is Manoj on for Akash. Just one from our end. Are you hearing any feedback from the prescribers who switched from the CAMZYOS, especially like the efficacy with the lower doses? Approximately what percentage of your new patient adds are outside the treatment of the center of excellence? Thank you.

Manoj Eradath: Hey. This is Manoj. Hey. Sorry. This is Manoj on for Akash. Just one from our end. Are you hearing any feedback from the prescribers who switched from the CAMZYOS, especially like the efficacy with the lower doses? Approximately what percentage of your new patient adds are outside the treatment of the center of excellence? Thank you.

Speaker #8: This is Manoj. Hey, sorry, this is Manoj on for Akash. Just one from our end: Are you hearing any feedback from the prescribers who switched from the CAMSEOS, especially regarding the efficacy with the lower doses?

Speaker #8: And approximately what percentage of your new patient ads are outside the treatment of the center of excellence? Thank you.

Speaker #5: So if I understood your question correctly, are we hearing anything with respect to Mavicampton as it relates to lower doses?

Robert Blum: If I understood your question correctly, are we hearing anything with respect to mavacamten as it relates to lower doses? The prescription-

Robert Blum: If I understood your question correctly, are we hearing anything with respect to mavacamten as it relates to lower doses? The prescription-

Speaker #8: Yeah. The patients from Mavicampton and your efficacy with the lower doses of API?

[Analyst] (Jefferies): Yeah. The patient switch from CAMZYOS and your efficacy with the lower doses of aficamten.

Manoj Eradath: Yeah. The patient switch from CAMZYOS and your efficacy with the lower doses of aficamten.

Speaker #5: Yeah. So it's not for us really to comment on CAMSEOS and lower doses. But Andrew, is there anything you want to say about API Campton myCorso and how doses are being titrated?

Robert Blum: Yeah. It's not for us really to comment on CAMZYOS and lower doses. Andrew, is there anything you want to say about aficamten MYQORZO and how doses are being titrated? Perhaps tackle the second question, which relates to prescribing outside of Velocity accounts.

Robert Blum: Yeah. It's not for us really to comment on CAMZYOS and lower doses. Andrew, is there anything you want to say about aficamten MYQORZO and how doses are being titrated? Perhaps tackle the second question, which relates to prescribing outside of Velocity accounts.

Speaker #5: And then perhaps tackle the second question, which relates to prescribing outside of velocity accounts.

Speaker #3: Sure. So in terms of dosing, we do have a flexible dosing window. A physician can increase a dose with each echo, and we're seeing that dosing window play out in the real world, where some patients are being dosed as quickly as two weeks, and other patients are having their dose increased as long as two months.

Andrew Callos: Sure. In terms of dosing, we do have a flexible dosing window. A physician can increase a dose with each echo, and we are seeing that dosing window play out in real world, where some patients are being dosed as quickly as 2 weeks, and other patients are being increased dose as long as 2 months. That is really between the logistics of a center, a patient's, and a physician's scheduling. That window is taking place across every dose change. Relative to breadth and depth of prescribing, we have a really good mix in terms of breadth. The majority of our prescriptions and prescribers are in that high CMI category. That is about 40% overall. That low volume category is about 30%. The CMI naive, meaning they had not written a CMI until we have entered the market, is 30% of our prescribers.

Andrew Callos: Sure. In terms of dosing, we do have a flexible dosing window. A physician can increase a dose with each echo, and we are seeing that dosing window play out in real world, where some patients are being dosed as quickly as 2 weeks, and other patients are being increased dose as long as 2 months. That is really between the logistics of a center, a patient's, and a physician's scheduling. That window is taking place across every dose change.

Speaker #3: And that's really between the logistics of a center, a patient, and a physician's scheduling. So that window is taking place across every dose change.

Speaker #3: Relative to breadth and depth of prescribing, we have a really good mix in terms of breadth. The majority of our prescriptions and prescribers are in that high CMI category.

Andrew Callos: Relative to breadth and depth of prescribing, we have a really good mix in terms of breadth. The majority of our prescriptions and prescribers are in that high CMI category. That is about 40% overall. That low volume category is about 30%. The CMI naive, meaning they had not written a CMI until we have entered the market, is 30% of our prescribers.

Speaker #3: That's about 40% overall. But then that low volume category is about 30%. And the CMI naive, meaning they had not written a CMI until we've entered the market, is 30% of our prescribers.

Speaker #3: So we're doing really well across a broader range of prescribers. When we talk to those CMI-naive prescribers, anecdotally, we're really hearing what you saw on that slide around differentiation.

Andrew Callos: We are doing really well across a broader range of prescribers. When we talk to those CMI-naive prescribers anecdotally, we are really hearing what you saw on that slide around differentiation. It really comes down to the REMS, the dosing window, the dosing flexibility, the lack of DDI monitoring as part of the overall REMS program, and they are the reasons we hear from those, generally from that CMI naive, in terms of why initiation of a CMI at this point. Hopefully, that answers your question.

Andrew Callos: We are doing really well across a broader range of prescribers. When we talk to those CMI-naive prescribers anecdotally, we are really hearing what you saw on that slide around differentiation. It really comes down to the REMS, the dosing window, the dosing flexibility, the lack of DDI monitoring as part of the overall REMS program, and they are the reasons we hear from those, generally from that CMI naive, in terms of why initiation of a CMI at this point. Hopefully, that answers your question.

Speaker #3: It really comes down to the REMS, the dosing window, the dosing flexibility, the lack of DDI monitoring as part of it, the overall REMS program.

Speaker #3: And they're the reasons we hear from those generally from that CMI-naive group in terms of why initiation of a CMI at this point. Hopefully, that answers your question.

Speaker #5: Yeah. Thank you.

[Analyst] (Jefferies): Yes. Thank you.

Manoj Eradath: Yes. Thank you.

Speaker #2: If you think about what may be hovering well with regard to a exceeding of expectations associated with prescribing down the road, it's going to be the number of prescriptions repeat prescriptions coming from each of these segments and an expansion of the category.

Robert Blum: If you think about what may be auguring well with regard to an exceeding of expectations associated with prescribing down the road, it is going to be the number of prescriptions, repeat prescriptions, coming from each of these segments and an expansion of the category. I think Andrew commented on both of those in his scripted comments. We are especially encouraged to see the high-volume writers writing the number of prescriptions that they are, but also that 50% of the prescriptions are coming from folks who are otherwise new or low-volume prescribers. That suggests to me that we are seeing category expansion as you should expect of us. Next question, please.

Robert Blum: If you think about what may be auguring well with regard to an exceeding of expectations associated with prescribing down the road, it is going to be the number of prescriptions, repeat prescriptions, coming from each of these segments and an expansion of the category. I think Andrew commented on both of those in his scripted comments.

Speaker #2: And I think Andrew commented on both of those. In his scripted comments, we're especially encouraged to see the high volume writers writing the number of prescriptions that they are, but also that 50% of the prescriptions are coming from folks who were otherwise new or low volume prescribers.

Robert Blum: We are especially encouraged to see the high-volume writers writing the number of prescriptions that they are, but also that 50% of the prescriptions are coming from folks who are otherwise new or low-volume prescribers. That suggests to me that we are seeing category expansion as you should expect of us. Next question, please.

Speaker #2: That suggests to me that we're seeing category expansion as you should expect of us.

Speaker #5: Next question, please.

Speaker #3: Our next question comes from the line of Paul Choi with Goldman Sachs. Paul, your line is open.

Operator: Our next question comes from the line of Paul Choi with Goldman Sachs. Paul, your line is open.

Operator: Our next question comes from the line of Paul Choi with Goldman Sachs. Paul, your line is open.

Speaker #6: Hi, good afternoon, and thanks for taking my questions. Apologies for any background noise. As you think about your commercialization efforts over the coming year, you'll be launching in symptomatic oHCM, frontline oHCM.

Paul Choi: Hi, good afternoon, and thanks for taking my questions. Apologies for any background noise. As you think about your commercialization efforts over the coming year, you'll be launching in symptomatic OHCM, frontline OHCM, and NHCM, which is a lot of data to put in front of doctors. As you think about your messaging, can you maybe clarify for us how you'll sort of think about all these opportunities and present them to doctors as your salesforce is in the field over the next year? Thank you.

Paul Choi: Hi, good afternoon, and thanks for taking my questions. Apologies for any background noise. As you think about your commercialization efforts over the coming year, you'll be launching in symptomatic OHCM, frontline OHCM, and NHCM, which is a lot of data to put in front of doctors. As you think about your messaging, can you maybe clarify for us how you'll sort of think about all these opportunities and present them to doctors as your salesforce is in the field over the next year? Thank you.

Speaker #6: And then NHCM, which is a lot of data to put in front of doctors, and as you think about your messaging, can you maybe clarify for us how you'll sort of think about all these opportunities and presenting them to doctors as your sales force is in the field over the next year?

Speaker #6: Thank you.

Speaker #2: Yeah. So maybe I'll ask both Fady and Steve to start because they're obviously on the forward edge of these studies. And as they get reported, presented, and published, the medical colleagues are already speaking to some of these things and then Andrew and his commercial team pick up from there.

Robert Blum: Yeah. Maybe I'll ask both Fady and Steve to start because they're obviously on the forward edge of these studies. As they get reported, presented, and published, the medical colleagues are already speaking to some of these things. Andrew and his commercial team pick up from there. Fady, do you want to start and then Andrew afterwards?

Robert Blum: Yeah. Maybe I'll ask both Fady and Steve to start because they're obviously on the forward edge of these studies. As they get reported, presented, and published, the medical colleagues are already speaking to some of these things. Andrew and his commercial team pick up from there. Fady, do you want to start and then Andrew afterwards?

Speaker #2: So, Fady, do you want to start, and then Andrew afterwards?

Speaker #4: Yeah. I mean, it really starts with dissemination of the data through published literature and Steve and his team have been extremely productive in terms of not just the primary publications, but secondary publications that expand on the initial findings.

Fady Malik: Yeah. It really starts with dissemination of the data through published literature, Steve and his team have been extremely productive in terms of not just the primary publications, but secondary publications that expand on the initial findings. With that, our medical affairs team is regularly interacting with the most elite prescribers and physicians taking care of these HCM patients, bringing them the information, help them walk them through it in concise but complete manners. Finally, through executing a number of educational programs, either through CME or industry-sponsored symposia. A pretty complete program from the primary publications through to delivering the information through a variety of channels. Ultimately, our commercial colleagues will build on what gets into label and be able to then also disseminate the information broadly to their customer base.

Fady Malik: Yeah. It really starts with dissemination of the data through published literature, Steve and his team have been extremely productive in terms of not just the primary publications, but secondary publications that expand on the initial findings. With that, our medical affairs team is regularly interacting with the most elite prescribers and physicians taking care of these HCM patients, bringing them the information, help them walk them through it in concise but complete manners.

Speaker #4: With that, our medical affairs team is regularly interacting with the most elite prescribers and physicians taking care of these HCM patients, bringing them the information helping walk them through it and concise but complete manners.

Speaker #4: And finally, through executing a number of educational programs either through CME or industry sponsored symposia. So pretty complete program from the primary publications through to delivering the information through a variety of channels.

Fady Malik: Finally, through executing a number of educational programs, either through CME or industry-sponsored symposia. A pretty complete program from the primary publications through to delivering the information through a variety of channels. Ultimately, our commercial colleagues will build on what gets into label and be able to then also disseminate the information broadly to their customer base.

Speaker #4: And ultimately, our commercial colleagues will build on what gets into label and be able to then also disseminate the information broadly to their customer base.

Paul Choi: Thank you.

Paul Choi: Thank you.

Speaker #3: So I can ask? Yeah. Sorry. Thanks, Fady. I can maybe just add to it from a commercial point of view. It's a great challenge in terms of having so much data.

Robert Blum: So I-

Robert Blum: So I-

Fady Malik: Thanks for the question.

Fady Malik: Thanks for the question.

Andrew Callos: Sure, I can add-

Andrew Callos: Sure, I can add-

Robert Blum: Andrew, do you want to add?

Robert Blum: Andrew, do you want to add?

Andrew Callos: Yeah, sorry. Thanks, Fady. I can maybe just add to it from a commercial point of view. It's a great challenge in terms of having so much data in this period of time. When we think about MAPLE-HCM, we've done a lot of research on this as well. From a physician point of view, it broadens their horizon in terms of who they think an appropriate patient is for a CMI. We'll certainly highlight that for a physician. That's especially true for those low writers and the naive CMI writers, meaning they haven't written before. Or they certainly feel like they have the appropriate patient when you consider them relative to a beta-blocker. Guidelines have certainly fueled that. More of that were to change in 2027.

Andrew Callos: Yeah, sorry. Thanks, Fady. I can maybe just add to it from a commercial point of view. It's a great challenge in terms of having so much data in this period of time. When we think about MAPLE-HCM, we've done a lot of research on this as well. From a physician point of view, it broadens their horizon in terms of who they think an appropriate patient is for a CMI. We'll certainly highlight that for a physician. That's especially true for those low writers and the naive CMI writers, meaning they haven't written before. Or they certainly feel like they have the appropriate patient when you consider them relative to a beta-blocker. Guidelines have certainly fueled that. More of that were to change in 2027.

Speaker #3: In this period of time, when we think about MAPLE—MAPLE, we've done a lot of research on this as well. From a physician's point of view, it broadens the horizon in terms of who they think an appropriate patient is for a CMI.

Speaker #3: So we'll certainly highlight that for a physician. Especially true for those low writers and the naive CMI writers, meaning they haven't written before. Where they certainly feel like they have the appropriate patient when you consider them relative to a beta blocker.

Speaker #3: Guidelines to certainly fuel that more if that were to change in 2027. NHCM then really just broadens the spectrum of the number of patients a physician and a cardiology office can have with a single agent in my corso if it's approved for NHCM to treat a broader range of patients.

Andrew Callos: NHCM really just broadens the spectrum of the number of patients a physician in a cardiology office can have with a single agent in MYQORZO, if it's approved for NHCM, to treat a broader range of patients. We have our messaging cascaded, we have our visual aids cascaded, et cetera, and I think we'll be ready to take well advantage of that further differentiation should those approvals come in from a regulatory point of view.

Andrew Callos: NHCM really just broadens the spectrum of the number of patients a physician in a cardiology office can have with a single agent in MYQORZO, if it's approved for NHCM, to treat a broader range of patients. We have our messaging cascaded, we have our visual aids cascaded, et cetera, and I think we'll be ready to take well advantage of that further differentiation should those approvals come in from a regulatory point of view.

Speaker #3: So we have our messaging cascaded. We have our vis aids cascaded, etc. And I think we'll be ready to take well advantage of that further differentiation should those approvals come in from a regulatory point of view.

Speaker #2: You know, Paul, to your question, we aim to keep it simple. And what I am especially pleased to see is how we have great coordination across functions at Cytokinetics.

Robert Blum: Paul, to your question, we aim to keep it simple, and what I especially am pleased to see is how we have great coordination across functions at Cytokinetics. You asked about publications and communications in the field. What I'll also point you to is the abundance of secondary manuscripts and other publications that build off of the primary manuscripts. There's a plethora of information that's informing physicians about how best to think about aficamten, MYQORZO, and I do think that that's translated to awareness, significant education, and pull-through in patient demand as is enabling of our commercial colleagues to do so well. Hats off to the medical colleagues who make it happen on the publication side, and then the commercial folks can keep it simple when they are out there detailing physicians.

Robert Blum: Paul, to your question, we aim to keep it simple, and what I especially am pleased to see is how we have great coordination across functions at Cytokinetics. You asked about publications and communications in the field. What I'll also point you to is the abundance of secondary manuscripts and other publications that build off of the primary manuscripts.

Speaker #2: You asked about publications and communications in the field. But I'll also point you to is the abundance of secondary manuscripts and other publications that build off of the primary manuscripts.

Speaker #2: There's a plethora of information that's informing physicians about how best to think about aficamten, myo-cursor, and I do think that that's translated to awareness, significant education, and pull-through and patient demand, as is enabling our commercial colleagues to do so well.

Robert Blum: There's a plethora of information that's informing physicians about how best to think about aficamten, MYQORZO, and I do think that that's translated to awareness, significant education, and pull-through in patient demand as is enabling of our commercial colleagues to do so well. Hats off to the medical colleagues who make it happen on the publication side, and then the commercial folks can keep it simple when they are out there detailing physicians.

Speaker #2: So hats off to the medical colleagues who make it happen on the publication side and then the commercial folks can keep it simple when they are out there detailing physicians.

Speaker #3: Our next question comes from the line of James Condulis with Stiefel. James, your line is open.

Operator: Our next question comes from the line of James Condulis with Stifel. James, your line is open.

Operator: Our next question comes from the line of James Condulis with Stifel. James, your line is open.

Speaker #6: Hey, thanks for taking my question and congrats on all the progress. Maybe on the non-obstructive side, I'm curious as you started sort of these SNDA discussions, do you expect any sort of differences on the label or the REMS with the potential approval of non-obstructive?

James Condulis: Hey, thanks for taking my question. Congrats on all the progress. Maybe on the non-obstructive side, curious, as you started sort of these sNDA discussions, do you expect any sort of differences on the label or the REMS with the potential approval of non-obstructive? Appreciate any color you can share. Thanks.

James Condulis: Hey, thanks for taking my question. Congrats on all the progress. Maybe on the non-obstructive side, curious, as you started sort of these sNDA discussions, do you expect any sort of differences on the label or the REMS with the potential approval of non-obstructive? Appreciate any color you can share. Thanks.

Speaker #6: Appreciate any colleague can share. Thanks.

Speaker #2: Yeah. So it's premature to speak to that. Obviously, we haven't even submitted the SNDA nor had conversations with FDA following their review of a submitted SNDA.

Robert Blum: Yeah. It's premature to speak to that. Obviously, we haven't even submitted the sNDA, nor had conversations with FDA following their review of a submitted sNDA. I do expect that for what could be this being a separate trial, there will be some distinctions that'll have to reflect NHCM versus OHCM. Maybe we shouldn't front run any of that until we have actually interacted with FDA following a submission.

Robert Blum: Yeah. It's premature to speak to that. Obviously, we haven't even submitted the sNDA, nor had conversations with FDA following their review of a submitted sNDA. I do expect that for what could be this being a separate trial, there will be some distinctions that'll have to reflect NHCM versus OHCM. Maybe we shouldn't front run any of that until we have actually interacted with FDA following a submission.

Speaker #2: But I do expect that, for what could be this being a separate trial, there will be some distinctions that will have to reflect NHCM versus OHCM. But maybe we shouldn't front-run any of that until we have actually interacted with the FDA following a submission.

James Condulis: Thanks.

James Condulis: Thanks.

Speaker #6: Thanks.

Speaker #2: Sure.

Robert Blum: Sure.

Robert Blum: Sure.

Speaker #3: Our next question comes from the line of Jason Butler with Citizens. Jason, your line is open.

Operator: Our next question comes from the line of Jason Butler with Citizens. Jason, your line is open.

Operator: Our next question comes from the line of Jason Butler with Citizens. Jason, your line is open.

Speaker #5: Hi. Thanks for taking the question and congrats on the quarter. Robert, can you just walk us through your expectations for the cohort one of olecamptin?

Jason Butler: Hi, thanks for taking the question and congrats on the quarter. Robert, can you just walk us through your expectations for the cohort 1 of ulacamten? How are you thinking about what you can learn from that cohort, specifically about the safety profile as well as PK/PD? Thanks.

Jason Butler: Hi, thanks for taking the question and congrats on the quarter. Robert, can you just walk us through your expectations for the cohort 1 of ulacamten? How are you thinking about what you can learn from that cohort, specifically about the safety profile as well as PK/PD? Thanks.

Speaker #5: How are you thinking about what you can learn from that cohort specifically about the safety profile as well as PKPD? Thanks.

Speaker #4: Sure. So I'll turn that over to Fadi, please. Yeah. So I mean, I think as we've said before, Amber is a mostly a dose-finding trial.

Robert Blum: Sure. I'll turn that over to Fady, please.

Robert Blum: Sure. I'll turn that over to Fady, please.

Fady Malik: I think as we've said before, AMBER-HFpEF is mostly a dose-finding trial, and to understand how the unique mechanism of ulacamten might play out in HFpEF population. We'll have initial PK. We'll be looking broadly across echocardiographic parameters. Of course, we'll have safety. We'll also understand the feasibility of enrolling a population focused to where we think the impact might be felt with a mechanism like ulacamten. I think over the course of the study, that'll help inform the continued development of ulacamten in this indication.

Fady Malik: I think as we've said before, AMBER-HFpEF is mostly a dose-finding trial, and to understand how the unique mechanism of ulacamten might play out in HFpEF population. We'll have initial PK. We'll be looking broadly across echocardiographic parameters. Of course, we'll have safety. We'll also understand the feasibility of enrolling a population focused to where we think the impact might be felt with a mechanism like ulacamten. I think over the course of the study, that'll help inform the continued development of ulacamten in this indication.

Speaker #4: And to understand how the unique mechanism of olecamptin might play out in have test population so we'll have initial PK. We'll be looking broadly across echocardiographic parameters.

Speaker #4: Of course, we'll have safety and we'll also understand the feasibility of enrolling a population focused to where we think the impact might be felt with a mechanism like olecamptin.

Speaker #4: So I think over the course of the study, that'll help inform the continued development of olecamptin in this indication.

Robert Blum: Thanks, Jason.

Robert Blum: Thanks, Jason.

Speaker #2: Thanks, Jason.

Speaker #3: Our next question comes from the line of Corey Kazimov with Evercore. Corey, your line is open.

Operator: Our next question comes from the line of Cory Kasimov with Evercore. Cory, your line is open.

Operator: Our next question comes from the line of Cory Kasimov with Evercore. Cory, your line is open.

Speaker #7: Hey, this is Josh on for Corey. Thanks for taking our question. What percent of the OHCM market is penetrated by CMIs today? And what do you anticipate a peak penetration could be for the class?

[Analyst] (Evercore): Hey, this is Josh on for Cory. Thanks for taking our question. What % of the OHCM market is penetrated by CMIs today, and what do you anticipate a peak penetration could be for the class? Thanks.

[Analyst] (Evercore): Hey, this is Josh on for Cory. Thanks for taking our question. What % of the OHCM market is penetrated by CMIs today, and what do you anticipate a peak penetration could be for the class? Thanks.

Speaker #4: So maybe I'll turn to

Robert Blum: Maybe I'll turn to you, Andrew, for that, please.

Robert Blum: Maybe I'll turn to you, Andrew, for that, please.

Speaker #2: you, Andrew, for that, please.

Speaker #3: Sure. Our guess is around 110 to 120,000. It's more than a guess based on the analytics we've done. From an epi point of view, around that number is the eligible patient population that's if diagnosis doesn't increase.

Andrew Callos: Our guess is around 110,000 to 120,000. It's more than a guess. Based on the analytics we've done from an epi point of view around that number is the eligible patient population. That's if diagnosis doesn't increase. There's probably in the 20,000 to 25,000 range of treated patients. You get a penetration in around 20% range. Peak penetration I think will depend over time on access, demonstrated safety, if REMS programs change, et cetera. I would anticipate peak penetration in the 60% to 70% range.

Andrew Callos: Our guess is around 110,000 to 120,000. It's more than a guess. Based on the analytics we've done from an epi point of view around that number is the eligible patient population. That's if diagnosis doesn't increase. There's probably in the 20,000 to 25,000 range of treated patients. You get a penetration in around 20% range. Peak penetration I think will depend over time on access, demonstrated safety, if REMS programs change, et cetera. I would anticipate peak penetration in the 60% to 70% range.

Speaker #3: There's probably in the 20,000 to 25,000 range of treated patients, so you get a penetration in around the 20% range. Peak penetration, I think, will depend over time on access and demonstrated safety.

Speaker #3: If REMS programs change, etc. But I would anticipate peak penetration in the 60 to 70% range.

Speaker #2: Yeah, so what Andrew's citing would suggest that we've got a long way to go still to see CMIs penetrate a majority of the patients who are diagnosed and eligible.

Robert Blum: Yeah. What Andrew's citing would suggest that we've got a long way to go still to see CMIs penetrate a majority of the patients who are diagnosed and eligible, and there could be still others that could be diagnosed now that there's new medicines available to those patients. This is the beginning of what hopefully will be penetration of MYQORZO into more and more of those patients. Assume we're closer to 20% of the total eligible today, and that number, hopefully denominator grows. Next question, please.

Robert Blum: Yeah. What Andrew's citing would suggest that we've got a long way to go still to see CMIs penetrate a majority of the patients who are diagnosed and eligible, and there could be still others that could be diagnosed now that there's new medicines available to those patients. This is the beginning of what hopefully will be penetration of MYQORZO into more and more of those patients. Assume we're closer to 20% of the total eligible today, and that number, hopefully denominator grows. Next question, please.

Speaker #2: And there could be still others that could be diagnosed now that there's new medicines available to those patients. So, this is the beginning. Hopefully, there will be penetration of mycorsa into more and more of those patients, but assume we're closer to 20% of the total eligible today.

Speaker #2: And that number, hopefully, the denominator grows.

Speaker #4: Next question, please.

Speaker #3: Our next question comes from the line of Leonid Timashev with RBC. Your line is open.

Operator: Our next question comes from the line of Leonid Timashev with RBC. Your line is open.

Operator: Our next question comes from the line of Leonid Timashev with RBC. Your line is open.

Speaker #7: Hey, thanks for taking my question. I wanted to ask on comet just given the pace of enrollment, how are you thinking about the timing of the interim, your expectations for that interim, and then ultimately what would be clinically meaningful on comet?

Leonid Timashev: Yeah, thanks for taking my question. I wanted to ask on COMET. Given the pace of enrollment, how are you thinking about the timing of the interim, your expectations for that interim, and then ultimately, what would be clinically meaningful on COMET? Thanks.

Leonid Timashev: Yeah, thanks for taking my question. I wanted to ask on COMET. Given the pace of enrollment, how are you thinking about the timing of the interim, your expectations for that interim, and then ultimately, what would be clinically meaningful on COMET? Thanks.

Speaker #7: Thanks.

Speaker #2: Thank you. Fadi, please.

Robert Blum: Thank you. Fady, please.

Robert Blum: Thank you. Fady, please.

Speaker #4: Yeah. I mean, the pace of enrollment in comet is been pretty pleasing to us over the last few months. And I would say not providing specific guidance on when we think it'll complete enrollment, but it'll be into the beginning of 2027 for sure.

Fady Malik: I mean, the pace of enrollment in COMET has been pretty pleasing to us over the last few months. We're, I would say, not providing specific guidance on when we think it'll complete enrollment, but it'll be into the beginning of 2027 for sure. The interim analysis has a pretty high bar to stop the trial on the basis of efficacy. My expectations for stopping at the interim analysis are pretty low, because it's a very minute bit of alpha that's spent there. Clinically, the trial was designed, and we always try and do this, design a trial with the number of patients you think to demonstrate a minimally clinically beneficial effect and not overpower it to show de minimis effects, if you will. This trial was powered with that in mind.

Fady Malik: I mean, the pace of enrollment in COMET has been pretty pleasing to us over the last few months. We're, I would say, not providing specific guidance on when we think it'll complete enrollment, but it'll be into the beginning of 2027 for sure. The interim analysis has a pretty high bar to stop the trial on the basis of efficacy.

Speaker #4: The interim analysis has a pretty high bar to stop the trial on the basis of efficacy. I wouldn't necessarily I mean, my expectations for stopping at the interim analysis are pretty low because it's a very minute bit of alpha that's spent there.

Fady Malik: My expectations for stopping at the interim analysis are pretty low, because it's a very minute bit of alpha that's spent there. Clinically, the trial was designed, and we always try and do this, design a trial with the number of patients you think to demonstrate a minimally clinically beneficial effect and not overpower it to show de minimis effects, if you will. This trial was powered with that in mind.

Speaker #4: Clinically, we think anything trial was designed and we've always tried to do this, design a trial with the number of patients you think to demonstrate a minimally clinically beneficial effect and not overpower it to show de minimis effects, if you will.

Speaker #4: So this trial was powered with that in mind, and I think it should be statistically significant around 0.86, 0.87, 0.88. And that remains in terms of a hazard ratio for the primary endpoint.

Fady Malik: I think it should be statistically significant around 0.86, 0.87, 0.88 in that range in terms of the hazard ratio for the primary endpoint. Of course, I think when you looked at this treatment effect in GALACTIC-HF, we saw more sizable treatment effects in that and would hope to see that in COMET emerge as well. I hope that addresses your question, Leo.

Fady Malik: I think it should be statistically significant around 0.86, 0.87, 0.88 in that range in terms of the hazard ratio for the primary endpoint. Of course, I think when you looked at this treatment effect in GALACTIC-HF, we saw more sizable treatment effects in that and would hope to see that in COMET emerge as well. I hope that addresses your question, Leo.

Speaker #4: But of course, I think when you looked at this treatment effect in galactic, we saw more sizable treatment effects than that. And we hope to see that in comet emerge as well.

Speaker #4: So I hope that addresses your question, Leo.

Leonid Timashev: It does. Thank you.

Leonid Timashev: It does. Thank you.

Speaker #7: Yes. Thank you.

Speaker #3: Our next question comes from the line of Amin Shaherli with B. Riley Securities. Your line is open.

Operator: Our next question comes from the line of Amin Shahirli with B. Riley Securities. Your line is open.

Operator: Our next question comes from the line of Amin Shahirli with B. Riley Securities. Your line is open.

Speaker #8: Hi, team. Congratulations on the quarter. This is Amin on from Mayank. I had a question for Andrew on the greater than 40% exit NBRX share.

Amin Shahirli: Hi, team. Congratulations on the quarter. This is Amin on for Mayank. Had a question for Andrew on the greater than 40% exit on NBRX share. Can you talk about what gets you to 50-plus by the end of the year? Is that mostly just 300 high-volume docs going deeper, or do you need the rest of that Velocity group coming on? Relatedly, when you put the full ACACIA data up at ESC, what do you think that does to OHCM prescribing near term?

Amine Chaherli: Hi, team. Congratulations on the quarter. This is Amin on for Mayank. Had a question for Andrew on the greater than 40% exit on NBRX share. Can you talk about what gets you to 50-plus by the end of the year? Is that mostly just 300 high-volume docs going deeper, or do you need the rest of that Velocity group coming on? Relatedly, when you put the full ACACIA data up at ESC, what do you think that does to OHCM prescribing near term?

Speaker #8: Can you talk about what gets you to 50 plus by the end of the year? Is that mostly the 300 high-volume docs? Going deeper, or do you need kind of the rest of that velocity group coming on?

Speaker #8: And then relatedly, when you put the full acacia data up at ESC, what do you think that does to OHCM prescribing near-term?

Speaker #2: Andrew, do you want to take that?

Robert Blum: Andrew, do you want to take that?

Robert Blum: Andrew, do you want to take that?

Speaker #3: Yeah, thanks for the question. So in terms of what gets us there, it's not going to be any one segment that gets us there.

Andrew Callos: Sure. Thanks for the question. In terms of what gets us there, it's not going to be any one segment that gets us there. It really is continuing utilization across all segments. The definition of a Velocity account for us was 80% of the market. That is actually shifting in terms of who are the Velocity prescribers as compared to who they were when we launched. Our expectation is that on a physician-by-physician basis, especially the academic centers and centers of excellence, where we certainly want to continue to grow share as we have been doing for the majority of them. Also getting on board the CMI-naive segment as well as that segment who hasn't really written much from a CMI. Many of them were referring. With NHCM, getting to your second question, obviously it's not approved.

Andrew Callos: Sure. Thanks for the question. In terms of what gets us there, it's not going to be any one segment that gets us there. It really is continuing utilization across all segments. The definition of a Velocity account for us was 80% of the market. That is actually shifting in terms of who are the Velocity prescribers as compared to who they were when we launched.

Speaker #3: It really is continuing utilization across all segments. The definition of a velocity account for us was 80% of the market. That is actually shifting in terms of who are the velocity prescribers.

Speaker #3: As compared to who they were when we launched. So our expectation is that on a physician-by-physician basis, especially the academic centers and centers of excellence where we certainly want to continue to grow share as we have been doing for the majority of them, but also getting on board the CMA naive segment as well as that kind of the segment who hasn't really written much from a CMI, many of them were referring.

Andrew Callos: Our expectation is that on a physician-by-physician basis, especially the academic centers and centers of excellence, where we certainly want to continue to grow share as we have been doing for the majority of them. Also getting on board the CMI-naive segment as well as that segment who hasn't really written much from a CMI. Many of them were referring. With NHCM, getting to your second question, obviously it's not approved.

Speaker #3: ing. And with NHCM, getting to your second question, obviously, it's not approved. We're not going to be promoting it or discussing it until it is approved.

Andrew Callos: We're not going to be promoting it or discussing it until it is approved. The fact that it will be published in the public domain, our expectation there probably will be some kind of overhang effect, if you will, in terms of increasing prescribing. When you have a third clinical trial, the obstructive HCM two trials with SEQUOIA and MAPLE and a third one with ACACIA, the continuous safety evidence efficacy is very reassuring to a physician as well. I think all this collectively will have an effect on OHCM. We anticipate continuing to grow share over time, and as we've said all along, our aspiration is to have greater than 50% of share by the end of the year. We're certainly on our way to do that.

Andrew Callos: We're not going to be promoting it or discussing it until it is approved. The fact that it will be published in the public domain, our expectation there probably will be some kind of overhang effect, if you will, in terms of increasing prescribing. When you have a third clinical trial, the obstructive HCM two trials with SEQUOIA and MAPLE and a third one with ACACIA, the continuous safety evidence efficacy is very reassuring to a physician as well.

Speaker #3: But the fact that it will be published in the public domain our expectation there will probably will be some kind of overhang effect, if you will, in terms of increasing prescribing when you have a third clinical trial obstructive HCM two trials with sequoia and maple on a third one with acacia.

Speaker #3: The continuous safety evidence efficacy is very reassuring to a physician as well. So I think all this collectively will have an effect on OHCM.

Andrew Callos: I think all this collectively will have an effect on OHCM. We anticipate continuing to grow share over time, and as we've said all along, our aspiration is to have greater than 50% of share by the end of the year. We're certainly on our way to do that.

Speaker #3: So we anticipate continuing to grow share. Over time, and as we've said all along, our aspiration is to have greater than 50% to share by the end of the year.

Speaker #3: We're certainly on our way to do that.

Speaker #8: Thank you.

Amin Shahirli: Thank you.

Amine Chaherli: Thank you.

Speaker #3: Thanks for the question. Our next question comes from the line of Maxwell Score with Mortgage Stanley. Maxwell, your line is open.

Andrew Callos: Thanks for the question.

Andrew Callos: Thanks for the question.

Operator: Our next question comes from the line of Maxwell Skor with Morgan Stanley. Maxwell, your line is open.

Operator: Our next question comes from the line of Maxwell Skor with Morgan Stanley. Maxwell, your line is open.

Speaker #8: Great. Thank you very much for taking my question. So far, we draw on the ChemZios experience. How should we think about persistence as the treated base builds?

Maxwell Skor: Great. Thank you very much for taking my question. If we draw on the CAMZYOS experience, how should we think about persistence as the treated base builds? Could it look different from MYQORZO given that it's differentiated dosing and titration regimen? Also, if I could ask, any thoughts on seasonality or how we should frame quarterly cadence heading into 2027? Thank you.

Maxwell Skor: Great. Thank you very much for taking my question. If we draw on the CAMZYOS experience, how should we think about persistence as the treated base builds? Could it look different from MYQORZO given that it's differentiated dosing and titration regimen? Also, if I could ask, any thoughts on seasonality or how we should frame quarterly cadence heading into 2027? Thank you.

Speaker #8: And could it look different for my corso given that it's differentiated dosing and titration regimen? And also, if I could ask, any thoughts on seasonality or how we should frame quarterly cadence heading into 2027?

Speaker #8: Thank you.

Robert Blum: Andrew, do you want to take that?

Robert Blum: Andrew, do you want to take that?

Speaker #2: Hey, do you want to take that?

Speaker #3: Sure. So from a persistence point of view, I mean, our expectation is that we will be the same, if not slightly better, from ChemZio's point of view, just given the profile of the drugs and some of the programs we're putting in place.

Andrew Callos: Sure. From a persistence point of view, our expectation is that we will be the same if not slightly better from CAMZYOS point of view, just given the profile of the drugs and some of the programs were put in place. I think it is reasonable to assume they would be similar if not slightly improved for MYQORZO. In terms of your second question was around. Can you repeat that part again? I'm not sure if I heard it.

Andrew Callos: Sure. From a persistence point of view, our expectation is that we will be the same if not slightly better from CAMZYOS point of view, just given the profile of the drugs and some of the programs were put in place. I think it is reasonable to assume they would be similar if not slightly improved for MYQORZO. In terms of your second question was around. Can you repeat that part again? I'm not sure if I heard it.

Speaker #3: But I think it's reasonable to assume they'd be similar if not slightly improved for my corso in terms of your second question was around can you repeat that part again?

Speaker #3: I'm not sure if I heard.

Speaker #8: Yeah. Just in regards to any thoughts on seasonality or how we should think or frame the quarterly cadence heading into '27.

Maxwell Skor: Yeah. Just in regards to any thoughts on seasonality or how we should think or frame the quarterly cadence heading into 2027.

Maxwell Skor: Yeah. Just in regards to any thoughts on seasonality or how we should think or frame the quarterly cadence heading into 2027.

Speaker #3: Sure. I mean, I think we always see a lag right before or right during a holiday week. There is flattening during the summertime. Physicians are on holiday or vacation, as are patients.

Andrew Callos: Sure. We always see a lag right before or right during a holiday week. There is flattening during the summertime. Physicians are on holiday or vacation as are patients. We see an uptick again in the Q4.

Andrew Callos: Sure. We always see a lag right before or right during a holiday week. There is flattening during the summertime. Physicians are on holiday or vacation as are patients. We see an uptick again in the Q4. The seasonality you'll see is usually around holidays, which is a minor point, but it's more flattening during that summertime, especially in the months of July and August.

Speaker #3: We see an uptick again in the fourth quarter. So, the seasonality you'll see is usually around holidays, which is a minor point. But it's more flattening during the summertime, especially in the months of July and August.

Robert Blum: The seasonality you'll see is usually around holidays, which is a minor point, but it's more flattening during that summertime, especially in the months of July and August.

Maxwell Skor: Great. Thank you.

Maxwell Skor: Great. Thank you.

Speaker #3: Thank you. Our next question comes from the line of Yasmin Rahimi with Piper Sandler Company. Yasmin, your line is open.

Robert Blum: Thank you.

Robert Blum: Thank you.

Operator: Our next question comes from the line of Yasmeen Rahimi with Piper Sandler Company. Yasmeen, your line is open.

Operator: Our next question comes from the line of Yasmeen Rahimi with Piper Sandler Company. Yasmeen, your line is open.

Speaker #9: Hi. This is Dominic on for Yas. Thank you for taking her question. And congrats on the good quarter. We just had a quick question on European launch.

[Analyst] (Piper Sandler): Hi, this is Dominic on for Yas. Thank you for taking our question, and congrats on the good quarter. We just had a quick question on European launch. How are you envisioning that panning out, especially as you continue to progress with US launch and launches in other European countries? Do you think that that will be a driver for subsequent launches? Thank you.

Dominic Risso-Gill: Hi, this is Dominic on for Yas. Thank you for taking our question, and congrats on the good quarter. We just had a quick question on European launch. How are you envisioning that panning out, especially as you continue to progress with US launch and launches in other European countries? Do you think that that will be a driver for subsequent launches? Thank you.

Speaker #9: How are you envisioning that panning out, especially as you continue to progress with the US launch and launches in other European countries? Do you think that will be a driver for subsequent launches?

Speaker #9: Thank you.

Speaker #2: Yeah, so maybe I'll start there and ask Andrew and also Sung maybe to comment. We're very committed to ensuring that mycapro is available to patients throughout Europe.

Robert Blum: Yeah. Maybe I'll start there and ask Andrew, and also Sung maybe to comment. We're very committed to ensuring that MYQORZO is available to patients throughout Europe. Now with our focus on certain countries and in partnering discussions as relate to others, we believe we can make that happen. At the same time, we're realistic about what moves the needle for the revenue line, and that's going to be more primarily obviously the US business. With that said, we're off to a great start in Germany, and we are very pleased with how we got some initial traction there in terms of stocking towards really just the last few weeks of the quarter. Now we've got to ensure that we're going to be enabling of demand and pull-through.

Robert Blum: Yeah. Maybe I'll start there and ask Andrew, and also Sung maybe to comment. We're very committed to ensuring that MYQORZO is available to patients throughout Europe. Now with our focus on certain countries and in partnering discussions as relate to others, we believe we can make that happen.

Speaker #2: Now, with our focus on certain countries and in partnering discussions as relate to others, we believe we can make that happen. But at the same time, we're realistic about what moves the needle.

Robert Blum: At the same time, we're realistic about what moves the needle for the revenue line, and that's going to be more primarily obviously the US business. With that said, we're off to a great start in Germany, and we are very pleased with how we got some initial traction there in terms of stocking towards really just the last few weeks of the quarter. Now we've got to ensure that we're going to be enabling of demand and pull-through. Andrew, do you want to speak to expectations in Europe and relative to US, and Sung, anything you want to add after that?

Speaker #2: For the revenue line, and that's going to be more primarily obviously the US business. With that said, we're off to a great start in Germany, and we are very pleased with how we got some initial traction there in terms of stocking towards really just the last few weeks of the quarter.

Speaker #2: And now we got to ensure that we're going to be enabling of demand and pull-through. Andrew, do you want to speak to expectations in Europe and relative to US and Sung, anything you want to add after that?

Robert Blum: Andrew, do you want to speak to expectations in Europe and relative to US, and Sung, anything you want to add after that? Yeah, sure. From a German point of view, it's early. We just launched in June. Data lags, but the data we've seen beyond the stocking is at, if not above our expectations from a German point of view. Other major markets, we're starting to get reimbursements in. We've talked about England and Wales. We've talked about the Netherlands. We have major markets launching, probably one at the end of this year, several H1 of next year. Europe takes more time to build up over from a revenue point of view. Pricing is in the 10% to 20% range.

Speaker #3: Yeah, sure. So from a German point of view, it's early. We just launched in June. Data lags, but the data we've seen beyond the stocking is at if not above our expectations from a German point of view.

Andrew Callos: Yeah, sure. From a German point of view, it's early. We just launched in June. Data lags, but the data we've seen beyond the stocking is at, if not above our expectations from a German point of view. Other major markets, we're starting to get reimbursements in. We've talked about England and Wales. We've talked about the Netherlands.

Speaker #3: In other major markets, we're starting to get reimbursements in. We've talked about England and Wales, we've talked about the Netherlands, and we have major markets launching.

Andrew Callos: We have major markets launching, probably one at the end of this year, several H1 of next year. Europe takes more time to build up over from a revenue point of view. Pricing is in the 10% to 20% range. My expectation would be that Europe will be a contribution but not a driver of growth, and over time, it'll probably be in the 15% range of our overall revenue. Maybe Sung wants to add to that.

Speaker #3: Probably one at the end of this year. Several first half of next year. Europe takes more time to build up over from a revenue point of view, pricing is in the 10 to 20 percent range.

Speaker #3: So my expectation would be that Europe will be a contributor but not a driver of growth. And over time, it'll probably be in the 15 percent range of our overall revenue.

Robert Blum: My expectation would be that Europe will be a contribution but not a driver of growth, and over time, it'll probably be in the 15% range of our overall revenue. Maybe Sung wants to add to that.

Speaker #3: But maybe Sung wants to add to that.

Speaker #2: Yeah, I think Andrew characterized the pace in Europe well. The launches are staggered as we go through the HPA process in each country. And the next likely country that we will launch in in Q4 is the UK.

Andrew Callos: Yeah. I think Andrew characterized the pace in Europe well. The launches are staggered as we go through the HTA process in each country, the next likely country that we will launch in in Q4 is the UK. We'll have subsequent launches into 2027, all the way to the end of 2027.

Sung Lee: Yeah. I think Andrew characterized the pace in Europe well. The launches are staggered as we go through the HTA process in each country, the next likely country that we will launch in in Q4 is the UK. We'll have subsequent launches into 2027, all the way to the end of 2027.

Speaker #2: And we'll have subsequent launches into 2027 all the way to the end of the end of 2027.

Speaker #3: We don't underestimate the challenges of going to market in the United States and also multiple countries in Europe at the same time. But I do believe we're executing very well across all these geographies.

Robert Blum: We don't underestimate the challenges of going to market in the United States and also multiple countries in Europe at the same time. I do believe we're executing very well across all these geographies and setting the table for the kinds of things that matter to shareholders, including top-line growth. Thank you for the question.

Robert Blum: We don't underestimate the challenges of going to market in the United States and also multiple countries in Europe at the same time. I do believe we're executing very well across all these geographies and setting the table for the kinds of things that matter to shareholders, including top-line growth. Thank you for the question.

Speaker #3: And setting the table for the kinds of things that matter to shareholders, including the top-line growth. Thank you for the question.

Speaker #9: Great. Thank you.

[Analyst] (Piper Sandler): Great. Thank you.

Dominic Risso-Gill: Great. Thank you.

Speaker #3: Our next question comes from the line of Srikripa, Devarakanta, with Truist. Your line is open.

Operator: Our next question comes from the line of Srikripa Devarakonda with Truist. Your line is open.

Operator: Our next question comes from the line of Srikripa Devarakonda with Truist. Your line is open.

Speaker #10: Hey, guys. Thank you so much for taking my question and congratulations on the quarter. Given the launch curve that you're seeing now and Purdue for Date for Maple in November, how are you expecting a potential approval to change this curve?

Srikripa Devarakonda: Hey, guys. Thank you so much for taking my question, and congratulations on the quarter. Given the launch curve that you're seeing now, and PDUFA date for MAPLE in November, how are you expecting a potential approval to change this curve? Do you expect it to have an immediate effect, or do you think it could take time for doctors to be more educated about MAPLE? Just a quick follow-up on the doctors that are REMS-certified. It looks like about 1,400 of them are REMS-certified. Can you remind me what percentage of them have prescribed the drug and if you're seeing any bottlenecks going from certification to prescription? Thank you.

Srikripa Devarakonda: Hey, guys. Thank you so much for taking my question, and congratulations on the quarter. Given the launch curve that you're seeing now, and PDUFA date for MAPLE in November, how are you expecting a potential approval to change this curve? Do you expect it to have an immediate effect, or do you think it could take time for doctors to be more educated about MAPLE?

Speaker #10: Do you expect it to have an immediate effect, or do you think it could take time for doctors to be more educated about Maple?

Speaker #10: And then just a quick follow-up on the doctors that are REMS certified. It looks like about 1,400 of them are REMS certified. Can you remind me what percentage of them have prescribed the drug?

Srikripa Devarakonda: Just a quick follow-up on the doctors that are REMS-certified. It looks like about 1,400 of them are REMS-certified. Can you remind me what percentage of them have prescribed the drug and if you're seeing any bottlenecks going from certification to prescription? Thank you.

Speaker #10: And if you're seeing any bottlenecks going from certification to prescription? Thank you.

Speaker #2: Andrew, do you want to tackle those, please?

Robert Blum: Andrew, do you want to tackle those, please?

Robert Blum: Andrew, do you want to tackle those, please?

Speaker #3: Sure. So from a REMS, I'll go backwards. From a REMS certification point of view, the ratio is about 30% in terms of those who prescribed versus those who are certified from a REMS point of view.

Andrew Callos: Sure. I'll go backwards. From a REMS certification point of view, the ratio is about a 30% ratio in terms of those who prescribed versus those who are certified from a REMS point of view. We continue to get REMS enrollments week after week. That certainly shows an intention to or attention to prescribe overall. Sometimes the certification occurs and prescribing occurs within the institution by another physician. It's a good indicator of future prescribing. Again, we're confident that that growth is going to continue from broad-based prescribing. In terms of MAPLE, assuming MAPLE gets added to the label, that certainly provides greater ability from a promotion point of view.

Andrew Callos: Sure. I'll go backwards. From a REMS certification point of view, the ratio is about a 30% ratio in terms of those who prescribed versus those who are certified from a REMS point of view. We continue to get REMS enrollments week after week. That certainly shows an intention to or attention to prescribe overall.

Speaker #3: We continue to get REMS enrollments week after week, which certainly shows an intention or attention to prescribe overall. Sometimes the certification occurs and prescribing happens within the institution by another physician.

Andrew Callos: Sometimes the certification occurs and prescribing occurs within the institution by another physician. It's a good indicator of future prescribing. Again, we're confident that that growth is going to continue from broad-based prescribing. In terms of MAPLE, assuming MAPLE gets added to the label, that certainly provides greater ability from a promotion point of view.

Speaker #3: So it's a good indicator of future prescribing. And again, we're confident that that growth is going to continue from broad-based prescribing. In terms of Maple, when Maple gets assuming Maple gets added to the label, that's certainly provides greater ability from a promotion point of view, probably the two things that I discussed earlier that really Maple does is one is it paints a picture, especially for low to non-prescribers of appropriate patients for a CMI.

Andrew Callos: Probably the two things that I discussed earlier that really MAPLE does is one is it paints a picture, especially for low to non-prescribers of appropriate patients for a CMI, and it broadens or it widens their mind in terms of who that appropriate patient is for. The other thing it does is certainly increases preference share and market growth. There's a kind of a multiplier factor there. If guidelines do get updated relative to MAPLE, that certainly would, as many physicians want to follow guidelines and understand guidelines, so that would be a further accelerator, but obviously that would take more time. To answer your question specifically, I would expect that we would get some level of impact.

Andrew Callos: Probably the two things that I discussed earlier that really MAPLE does is one is it paints a picture, especially for low to non-prescribers of appropriate patients for a CMI, and it broadens or it widens their mind in terms of who that appropriate patient is for. The other thing it does is certainly increases preference share and market growth.

Speaker #3: And it broadens or widens their mind in terms of who that appropriate patient is for. The other thing it does is certainly increase preference share and market growth.

Speaker #3: So there's a kind of a multiplier factor there if guidelines do get updated relative to Maple. That's certainly would as many physicians want to follow guidelines and understand guidelines.

Andrew Callos: There's a kind of a multiplier factor there. If guidelines do get updated relative to MAPLE, that certainly would, as many physicians want to follow guidelines and understand guidelines, so that would be a further accelerator, but obviously that would take more time. To answer your question specifically, I would expect that we would get some level of impact. Whether it will be noticeable right at launch or if it is going to take a bit of time, I would expect that it is probably going to take a bit of time, more likely than this big bolus of prescribing change.

Speaker #3: So that would be a further accelerator. But, obviously, that would take more time. So to answer your question specifically, I would expect that we would get some level of impact, whether it'll be noticeable right at launch or if it's going to take a bit of time.

Andrew Callos: Whether it will be noticeable right at launch or if it is going to take a bit of time, I would expect that it is probably going to take a bit of time, more likely than this big bolus of prescribing change.

Speaker #3: I would expect that it's probably going to take a bit of time more likely than this big bolus of prescribing change. Yep. Thanks for the question.

Srikripa Devarakonda: Thank you so much.

Srikripa Devarakonda: Thank you so much.

Andrew Callos: Yep. Thanks for the questions.

Andrew Callos: Yep. Thanks for the questions.

Speaker #3: Our next question comes from the line of Eric Joseph with Citi. Eric, your line is open.

Operator: Our next question comes from the line of Eric Joseph with Citi. Eric, your line is open.

Operator: Our next question comes from the line of Eric Joseph with Citi. Eric, your line is open.

Eric Joseph: Thanks for fitting me in. I just wanted to actually follow up on this point about REMS-certified HCPs given the growth that you saw this past quarter. Can you just talk about how that metric contrasts with the number of REMS-certified potential prescribers for CAMZYOS? What does that metric look like fully baked? Thanks.

Eric Joseph: Thanks for fitting me in. I just wanted to actually follow up on this point about REMS-certified HCPs given the growth that you saw this past quarter. Can you just talk about how that metric contrasts with the number of REMS-certified potential prescribers for CAMZYOS? What does that metric look like fully baked? Thanks.

Speaker #2: Thanks for fitting me in. I just wanted to actually follow up on this point about HCT or sorry, REMS certified. HCTs, given the growth that you saw this past quarter, can you just talk about sort of how that metric contrasts with the number of REMS certified writers for potential writers for TAMS IOS?

Speaker #2: And what does that metric look like fully baked? Thanks.

Speaker #3: So, are you asking how the REMS certification number compares to the TAMS iOS certification number? Is that your question?

Andrew Callos: Are you asking how our REMS certification number compares to the CAMZYOS certification number? Is that your question?

Andrew Callos: Are you asking how our REMS certification number compares to the CAMZYOS certification number? Is that your question?

Speaker #2: Yes. That and sort of what you anticipate the total number of potential REMS certified providers would be in the US.

Eric Joseph: Yes, that and what you anticipate the total number of potential REMS-certified providers would be in the US.

Eric Joseph: Yes, that and what you anticipate the total number of potential REMS-certified providers would be in the US.

Speaker #3: Got it. So I can't comment on the TAMS IOS REMS certification number. I don't know that number. I don't even know if that number is reported in a BMS reported it early in their launch, and it stopped reporting it at some point in time.

Andrew Callos: Got it. I can't comment on the CAMZYOS REMS certification number. I don't know that number. I don't even know if that number is reported. I know BMS reported it early in their launch, and it stopped reporting it at some point in time. In terms of our expectation, so we sized our field force for around 11,000 prescribers. Those 11,000 prescribers are around 80% of the treaters of HCM. Meaning that the majority of them are obviously using beta blockers, calcium channel blockers. We were going to where we thought the market would go with CMI penetration over time. With OHCM, if NHCM could get approved, our expectation is that prescribing base from around 3,000 in total today will increase to probably in the 7 to 10,000 range. Over time, I would expect we'd have greater than 5,000 REMS certifications.

Andrew Callos: Got it. I can't comment on the CAMZYOS REMS certification number. I don't know that number. I don't even know if that number is reported. I know BMS reported it early in their launch, and it stopped reporting it at some point in time. In terms of our expectation, so we sized our field force for around 11,000 prescribers. Those 11,000 prescribers are around 80% of the treaters of HCM. Meaning that the majority of them are obviously using beta blockers, calcium channel blockers.

Speaker #3: In terms of our expectation, we sized our field force for around 11,000 prescribers. Those 11,000 prescribers represent about 80% of the treaters of HCM.

Speaker #3: Meaning that the majority of them are obviously using beta blockers, calcium channel blockers. So we were going to where we thought the market would go with CMI penetration over time.

Andrew Callos: We were going to where we thought the market would go with CMI penetration over time. With OHCM, if NHCM could get approved, our expectation is that prescribing base from around 3,000 in total today will increase to probably in the 7 to 10,000 range. Over time, I would expect we'd have greater than 5,000 REMS certifications. We're very happy with the pace. The pace is outpacing the number of prescribers, which is exactly where we want to be.

Speaker #3: So with oHCM, if nHCM would get approved, our expectation is that the prescribing base, from around 3,000 in total today, will increase to probably in the 7,000 to 10,000 range.

Speaker #3: So over time, I would expect we'd have greater than 5,000 REMS certifications. But we're happy, very happy with the pace. The pace is outpacing the number of prescribers.

Andrew Callos: We're very happy with the pace. The pace is outpacing the number of prescribers, which is exactly where we want to be.

Speaker #3: Which is exactly where we want to be.

Speaker #2: Yes. Talk about exceeding expectations. We're seeing those numbers track in terms of REMS certified HCPs. And how that's converting so promptly to new prescriptions prescribers, especially outside of velocity accounts.

Robert Blum: Yes. Talk about exceeding expectations. We're seeing those numbers track in terms of REMS-certified HCPs and how that's converting so promptly to new prescriptions, prescribers, especially outside of Velocity accounts.

Robert Blum: Yes. Talk about exceeding expectations. We're seeing those numbers track in terms of REMS-certified HCPs and how that's converting so promptly to new prescriptions, prescribers, especially outside of Velocity accounts.

Speaker #3: Great. Thanks for taking the questions. Our next question comes from the line of Yanin Zhu with Wells Fargo. Your line is open.

Eric Joseph: Great. Thanks for taking the questions.

Eric Joseph: Great. Thanks for taking the questions.

Operator: Our next question comes from the line of Yanan Zhu with Wells Fargo. Your line is open.

Operator: Our next question comes from the line of Yanan Zhu with Wells Fargo. Your line is open.

Speaker #5: Great. Thanks for taking our questions. And congrats on the quarter. Maybe a question on your FDA interaction. For the filing of the NHCM indication, I was curious has there been any particular questions or focuses from the agency?

Yanan Zhu: Great. Thanks for taking our questions and congrats on the quarter. Maybe a question on your FDA interaction for the filing of the NHCM indication. I was curious, has there been any particular questions or focuses from the agency? A quick question on the pattern of the final doses patients land on in a commercial setting and whether that is similar or different compared with your clinical trial experience. Thank you.

Yanan Zhu: Great. Thanks for taking our questions and congrats on the quarter. Maybe a question on your FDA interaction for the filing of the NHCM indication. I was curious, has there been any particular questions or focuses from the agency? A quick question on the pattern of the final doses patients land on in a commercial setting and whether that is similar or different compared with your clinical trial experience. Thank you.

Speaker #5: And then a quick question on the pattern of the final doses. Patients land on in a commercial setting, and how does whether that is similar or different compared with your clinical trial experience?

Speaker #5: Thank you.

Speaker #2: So I'll ask Fadi to comment, but caution you that it's not our practice to be speaking on a play-by-play basis with regard to ongoing FDA interactions.

Robert Blum: I'll ask Fady to comment, but caution you that it's not our practice to be speaking on a play-by-play basis with regard to ongoing FDA interactions. Maybe Andrew and Steve can talk about the doses that we're seeing patients relative commercial to clinical.

Robert Blum: I'll ask Fady to comment, but caution you that it's not our practice to be speaking on a play-by-play basis with regard to ongoing FDA interactions. Maybe Andrew and Steve can talk about the doses that we're seeing patients relative commercial to clinical.

Speaker #2: And then maybe Andrew and Steve can talk about the doses that we're seeing patients relative commercial to clinical.

Speaker #4: Sure. I think we presented as we presented the data the natural questions that anybody would have around reviewing product for potential approval in that indication include the clinical meaningfulness of the endpoints, and the results, the safety that was observed, how we might deploy those things in understand the interplay of those with the patient population.

Fady Malik: Sure. I think we presented as we presented the data, the natural questions that anybody would have around reviewing product for potential approval in that indication include the clinical meaningfulness of the endpoints and the results, the safety that was observed, how we might deploy those things and understand the interplay of those with the patient population. I think those are some of the themes of our discussion without getting too granular. I think we're well-placed to be able to address any questions in those areas.

Fady Malik: Sure. I think we presented as we presented the data, the natural questions that anybody would have around reviewing product for potential approval in that indication include the clinical meaningfulness of the endpoints and the results, the safety that was observed, how we might deploy those things and understand the interplay of those with the patient population. I think those are some of the themes of our discussion without getting too granular. I think we're well-placed to be able to address any questions in those areas.

Speaker #4: I think those are some of the themes of our discussion, without getting too granular. And I think we're well placed to be able to address any questions in those areas.

Speaker #2: What I can say is, we were pleased that there were no surprises. And then, Andrew, do you want to talk about the dose levels that people are achieving already commercially?

Robert Blum: What I can say is we were pleased that there were no surprises. Andrew, do you want to talk about the dose levels that people are achieving already commercially, and then Steve can comment about that in the context of clinical research?

Robert Blum: What I can say is we were pleased that there were no surprises. Andrew, do you want to talk about the dose levels that people are achieving already commercially, and then Steve can comment about that in the context of clinical research?

Speaker #2: And then Steve can comment on that in the context of clinical research.

Speaker #3: Yeah, sure. So, I mean, we are seeing a broad range of dosing, all the way up to the 20 milligram. I think it's too early to tell exactly where the mix is going to wind up, given the number of new patients. We continue to have the dosing window that physicians and patients are taking advantage of—that two- to eight-week window.

Andrew Callos: We are seeing a broad range of dosing all the way up to the 20 milligram. I think it's too early to tell exactly where the mix is going to wind up given the number of new patients we continue to have, the dosing window that physicians and patients are taking advantage of, that two to eight-week window. I think that certainly is something we're monitoring and trying to understand exactly where is dosing going to compare to clinical trials. Typically, what I've seen is dosing usually winds up slightly lower in terms of a percentage in clinical trials, but we'll certainly report on that number in the future. Steve, anything you want to add?

Andrew Callos: We are seeing a broad range of dosing all the way up to the 20 milligram. I think it's too early to tell exactly where the mix is going to wind up given the number of new patients we continue to have, the dosing window that physicians and patients are taking advantage of, that two to eight-week window.

Speaker #3: So I think that is certainly something we're monitoring and trying to understand—exactly where dosing is going to compare to clinical trials. Typically, what I've seen is dosing usually winds up slightly lower, in terms of percentage, than in clinical trials.

Andrew Callos: I think that certainly is something we're monitoring and trying to understand exactly where is dosing going to compare to clinical trials. Typically, what I've seen is dosing usually winds up slightly lower in terms of a percentage in clinical trials, but we'll certainly report on that number in the future. Steve, anything you want to add?

Speaker #3: But we'll certainly report on that number in the future. Steve, anything you want to add?

Stephen Heitner: Well, nothing more than say the obvious that the clinical trials did show the preponderance of patients ended up on the 15 and 20 milligram doses, both in MAPLE, SEQUOIA, and the data that we published out of the FOREST-HCM experience.

Steve Heitner: Well, nothing more than say the obvious that the clinical trials did show the preponderance of patients ended up on the 15 and 20 milligram doses, both in MAPLE, SEQUOIA, and the data that we published out of the FOREST-HCM experience.

Speaker #2: Well, I mean, nothing more than the obvious that the clinical trials did show the preponderance of patients ended up on the 15 and 20 milligram doses both in Maple, Sequoia, and the data that we've published out of the forest experience.

Speaker #2: That gives an opportunity to underscore one of the things that we think is important regarding myCorzo is that one can up titrate and that's enabling of convenience and flexibility for physicians and patients to feel like they can be moving to that dose which is most likely to be the best balance between efficacy and safety.

Robert Blum: That gives an opportunity to underscore one of the things that we think is important regarding MYQORZO is that one can up titrate, and that's enabling of convenience and flexibility for physicians and patients to feel like they can be moving to that dose, which is most likely to be the best balance between efficacy and safety without having to compromise.

Robert Blum: That gives an opportunity to underscore one of the things that we think is important regarding MYQORZO is that one can up titrate, and that's enabling of convenience and flexibility for physicians and patients to feel like they can be moving to that dose, which is most likely to be the best balance between efficacy and safety without having to compromise.

Speaker #2: Without having to compromise.

Speaker #5: Super helpful. Thank you, and congrats again.

Yanan Zhu: Super helpful. Thank you, and congrats again.

Yanan Zhu: Super helpful. Thank you, and congrats again.

Speaker #2: Thank you.

Robert Blum: Thank you.

Robert Blum: Thank you.

Speaker #3: Our next question comes from the line of Serge Ballanger with Needham. Your line is open.

Operator: Our next question comes from the line of Serge Bélanger with Needham. Your line is open.

Operator: Our next question comes from the line of Serge Bélanger with Needham. Your line is open.

Serge Bélanger: Good afternoon. Maybe the first one is for Andrew. I think in your slides you mentioned that about 300 of the 700 unique prescribers of MYQORZO through June were high volume CMI users. I assume these are also CAMZYOS users. Is there any indication at this point on whether these high volume prescribers will continue using both products or eventually they'll adopt just one? Secondly, for Robert, was there any discussions in your FDA meeting about a potential priority review for the upcoming NHCM sNDA? Thank you.

Serge Bélanger: Good afternoon. Maybe the first one is for Andrew. I think in your slides you mentioned that about 300 of the 700 unique prescribers of MYQORZO through June were high volume CMI users. I assume these are also CAMZYOS users. Is there any indication at this point on whether these high volume prescribers will continue using both products or eventually they'll adopt just one? Secondly, for Robert, was there any discussions in your FDA meeting about a potential priority review for the upcoming NHCM sNDA? Thank you.

Speaker #6: Hi, good afternoon. Maybe the first one for Andrew. I think in your slides, you mentioned about 300 of the 700 unique prescribers of myCarzo through June are high-volume CMI users.

Speaker #6: I assume these are also CanZios users. So, is there any indication at this point on whether these high-volume prescribers will continue using both products, or eventually they'll adopt just one?

Speaker #6: And then secondly, for Robert, was there any discussion in your FDA meeting about a potential priority review for the upcoming NHCM NDA? Thank you.

Speaker #2: Andrew, I'm not sure if you heard all of that question. Did you get it?

Robert Blum: Andrew, I'm not sure if you heard all of that question. Did you get it? I think I got the essence of it. The very beginning of it was very broken up. Serge, thanks for the question. I don't anticipate the majority of the prescribers will go 100% one way or the other. There certainly are those that are advocates for one product or the other that prescribe that way. The vast majority will use both products over time. Our expectation is that use of MYQORZO is greater than that of CAMZYOS for most prescribers, hence our aspiration in terms of greater than 50% share. I'm not anticipating that we would have 100% share for the majority of prescribers or anywhere near that. Robert.

Robert Blum: Andrew, I'm not sure if you heard all of that question. Did you get it?

Speaker #3: I think I got the essence of it at the very beginning of it was very broken up. But Serge, thanks for the question. I don't anticipate the majority of the prescribers will go 100% one way or the other.

Andrew Callos: I think I got the essence of it. The very beginning of it was very broken up. Serge, thanks for the question. I don't anticipate the majority of the prescribers will go 100% one way or the other. There certainly are those that are advocates for one product or the other that prescribe that way.

Speaker #3: There certainly are those that are advocates for one product or the other that prescribe that way. The vast majority will use both products over time.

Andrew Callos: The vast majority will use both products over time. Our expectation is that use of MYQORZO is greater than that of CAMZYOS for most prescribers, hence our aspiration in terms of greater than 50% share. I'm not anticipating that we would have 100% share for the majority of prescribers or anywhere near that. Robert.

Speaker #3: Our expectation is that use of Mycorzo is greater than that of CanZios for most prescribers. Hence, our aspiration in terms of greater than 50% share.

Speaker #3: But I'm not anticipating that we would have 100% share for the majority of prescribers or anywhere near that. Robert?

Speaker #2: And then to your question about FDA, and reasonableness of a priority review, I don't think we'll comment again on any of our specific interactions with FDA.

Robert Blum: To your question about FDA and reasonableness of a priority review, I don't think we'll comment again on any of our specific interactions with FDA. As we've stated publicly already, independent of any interactions with FDA, it's not unreasonable. It's reasonable to assume that a priority review might be possible. It's not a base case assumption. It certainly would be great if that happens, and we'll see if we can't make that happen.

Robert Blum: To your question about FDA and reasonableness of a priority review, I don't think we'll comment again on any of our specific interactions with FDA. As we've stated publicly already, independent of any interactions with FDA, it's not unreasonable. It's reasonable to assume that a priority review might be possible. It's not a base case assumption. It certainly would be great if that happens, and we'll see if we can't make that happen.

Speaker #2: But as we've stated publicly already, independent of any interactions with the FDA, it's not unreasonable—it's reasonable to assume that a priority review might be possible.

Speaker #2: It's not a base case assumption. But it certainly would be great if that happens. And we'll see if we can't make that happen.

Speaker #6: Great. Thank you.

Serge Bélanger: Great. Thank you.

Serge Bélanger: Great. Thank you.

Speaker #3: Our next question comes from the line of Jason Zamansky with Bank of America. Jason, your line is open.

Operator: Our next question comes from the line of Jason Zemansky with Bank of America. Jason, your line is open.

Operator: Our next question comes from the line of Jason Zemansky with Bank of America. Jason, your line is open.

Speaker #6: Hey, good afternoon. Congrats on the quarter and appreciate you squeezing us in. Maybe as a follow-up, potentially the last question. You indicated, I think, that about 5 to 7% of myCorzo dispenses are for those switching therapies.

Jason Zemansky: Hey, good afternoon. Congrats on the quarter and appreciate you squeezing us in. Maybe as a follow-up, potentially to the last question. You indicated, I think, that about 5% to 7% of MYQORZO dispenses are for those switching therapies. What are the primary factors driving those switches? Among those transitioning from mavacamten, what sort of feedback are you getting regarding the maintenance of symptoms and gradient control? Thanks.

Jason Zemansky: Hey, good afternoon. Congrats on the quarter and appreciate you squeezing us in. Maybe as a follow-up, potentially to the last question. You indicated, I think, that about 5% to 7% of MYQORZO dispenses are for those switching therapies. What are the primary factors driving those switches? Among those transitioning from mavacamten, what sort of feedback are you getting regarding the maintenance of symptoms and gradient control? Thanks.

Speaker #6: What are the primary factors driving those switches? And then among those transitioning from mavacamten, what sort of feedback are you getting regarding the maintenance of symptoms and gradient control?

Speaker #6: Thanks.

Speaker #2: Yeah, so obviously, there's nothing so systematic about that understanding that we can speak to it with any kind of robust fidelity. But there are anecdotes that we hear. Maybe Steve, if you want to comment on what might motivate a physician who would switch from CanZios to myCorzo?

Robert Blum: Yeah. Obviously there's nothing so systematic about that understanding that we can speak to it with any kind of robust fidelity. There are anecdotes that we hear. Maybe Steve Hytner, if you want to comment on what might motivate a physician who would switch from CAMZYOS to MYQORZO.

Robert Blum: Yeah. Obviously there's nothing so systematic about that understanding that we can speak to it with any kind of robust fidelity. There are anecdotes that we hear. Maybe Steve Hytner, if you want to comment on what might motivate a physician who would switch from CAMZYOS to MYQORZO.

Speaker #6: Sure. Before I get to that, I'll just point out that in MAPLE-HCM, prior exposure to mavacamten was allowed, and those participants had an expected therapeutic response to aficamten in that setting.

Stephen Heitner: Sure. Before I get to that, I'll just point out that in MAPLE-HCM, prior exposure to mavacamten was allowed. Those participants had an expected therapeutic response to mavacamten in that setting. To Robert Blum's point, there are some pharmacologic benefits that we believe suits certain patients more. Those are related firstly to the speed of onset and offset. Patients who may have specific indications where they may need to start and stop the drug with a rapid onset and offset, those are patients who would naturally be selected for mavacamten. Individuals who are considering starting a family. As you might be aware, with the CAMZYOS label, it's a black box warning. With MYQORZO, on the other hand, it certainly hasn't been studied, but it isn't a black box warning based on our preclinical data. The drug-drug interactions is something that you're well aware of.

Steve Heitner: Sure. Before I get to that, I'll just point out that in MAPLE-HCM, prior exposure to mavacamten was allowed. Those participants had an expected therapeutic response to mavacamten in that setting. To Robert Blum's point, there are some pharmacologic benefits that we believe suits certain patients more. Those are related firstly to the speed of onset and offset.

Speaker #6: Then, to Robert's point, there are some pharmacologic benefits that we believe suit certain patients more. Those are related, firstly, to the speed of onset and offset.

Speaker #6: So patients who may have specific indications where they may need to start and stop the drug with a rapid onset and offset, those are patients who would naturally be selected for Aficampton.

Steve Heitner: Patients who may have specific indications where they may need to start and stop the drug with a rapid onset and offset, those are patients who would naturally be selected for mavacamten. Individuals who are considering starting a family. As you might be aware, with the CAMZYOS label, it's a black box warning. With MYQORZO, on the other hand, it certainly hasn't been studied, but it isn't a black box warning based on our preclinical data. The drug-drug interactions is something that you're well aware of.

Speaker #6: Individuals who are considering starting a family—as you might be aware, with the CanZios label, there's a black box warning. With myCorzo, on the other hand, it certainly hasn't been studied.

Speaker #6: But it isn't a black box warning based on our preclinical data. The drug-drug interaction is something that you're well aware of. Patients who have had good experiences on certain kinds of antidepressants or therapies for things like gastroesophageal reflux disease may not necessarily want to switch medications in order to start a new medication for their hypertrophic cardiomyopathy.

Stephen Heitner: Patients who have had good experiences on certain kinds of antidepressants or therapies for things like gastroesophageal reflux disease may not necessarily want to switch medications in order to start a new medication for their hypertrophic cardiomyopathy. That would be another indication to preferentially use MYQORZO.

Steve Heitner: Patients who have had good experiences on certain kinds of antidepressants or therapies for things like gastroesophageal reflux disease may not necessarily want to switch medications in order to start a new medication for their hypertrophic cardiomyopathy. That would be another indication to preferentially use MYQORZO.

Speaker #6: That would be another indication to preferentially use myCorzo clinically.

Robert Blum: Maybe just annotating a bit on what Steve Hytner said. It is fundamentally not our strategy to drive switches. We are observing that there are certain physicians who are asking questions about how to switch. Some investigators have chosen to do a study that will inform that practice were that to be of interest. As Andrew Callos has spoken to prescribing and new prescriptions and share of new scripts, it's a modest percentage of the total that's driven by switches, that's potentially something for which there was more of a bolus of that activity early on in the launch. As we get deeper into the launch, we expect that may not continue to be a motivating factor for some of those physicians.

Speaker #2: Yeah. Maybe just annotating a bit on what Steve said. It is not fundamentally not our strategy to drive switches. We are observing that there are certain physicians who are asking questions about how to switch.

Robert Blum: Maybe just annotating a bit on what Steve Hytner said. It is fundamentally not our strategy to drive switches. We are observing that there are certain physicians who are asking questions about how to switch. Some investigators have chosen to do a study that will inform that practice were that to be of interest.

Speaker #2: Some investigators have chosen to conduct studies that will inform that practice, should it be of interest. But as Andrew has mentioned, when it comes to prescribing, new prescriptions, and the share of new scripts, it's a modest percentage of the total that's driven by switches.

Robert Blum: As Andrew Callos has spoken to prescribing and new prescriptions and share of new scripts, it's a modest percentage of the total that's driven by switches, that's potentially something for which there was more of a bolus of that activity early on in the launch. As we get deeper into the launch, we expect that may not continue to be a motivating factor for some of those physicians.

Speaker #2: And that's potentially something for which there was more of a bolus of that activity early on the launch. And as we get deeper into the launch, we expect that that may not continue to be a motivating factor for some of those physicians.

Speaker #2: So, all in all, what we're focused on is those patients who are naïve to CMI and where they may benefit from the addition of myCorzo to their regimen.

Robert Blum: All in all, what we're focused on is those patients who are naive to CMI and where they may benefit from the addition of MYQORZO to their regimen. That's where we're seeing the velocity, that's where we're seeing the growth, and that's where we see ultimately, the potential and upside for MYQORZO. Thank you.

Robert Blum: All in all, what we're focused on is those patients who are naive to CMI and where they may benefit from the addition of MYQORZO to their regimen. That's where we're seeing the velocity, that's where we're seeing the growth, and that's where we see ultimately, the potential and upside for MYQORZO. Thank you.

Speaker #2: And that's where we're seeing the velocity. That's where we're seeing the growth. And that's where we see, ultimately, the potential and upside for omecamtiv mecarbil.

Speaker #2: So thank you.

Speaker #3: We have reached the end of our Q&A session. I will now turn the call back to Robert Blum, CEO, for closing remarks.

Operator: We have reached the end of our Q&A session. I will now turn the call back to Robert Blum, CEO, for closing remarks.

Operator: We have reached the end of our Q&A session. I will now turn the call back to Robert Blum, CEO, for closing remarks.

Speaker #2: Thank you, operator. I want to thank the participants on the call today. I also want to thank you for your continued support and interest in how we're doing here at Cytokinetics.

Robert Blum: Thank you, operator. I want to thank the participants on the call today. I want to thank you for your continued support and interest in how we're doing here at Cytokinetics. I do believe that our Q2 report here is a very positive one, reflecting on the things that we've indicated matter. That which speaks to how we go commercial and enabling a strong commercial launch momentum and velocity here initially in the US and hopefully also as we're building the foundation in Europe. Having that occur at the same time we're enabling a better information to inform patient and market access, and also preparing for what we hope will be an expanded label to include NHCM based on the ACACIA data. I will remind you that we're going to have several presentations, including hotline presentation at ESC later this month.

Robert Blum: Thank you, operator. I want to thank the participants on the call today. I want to thank you for your continued support and interest in how we're doing here at Cytokinetics. I do believe that our Q2 report here is a very positive one, reflecting on the things that we've indicated matter. That which speaks to how we go commercial and enabling a strong commercial launch momentum and velocity here initially in the US and hopefully also as we're building the foundation in Europe.

Speaker #2: I do believe that our Q2 report here is a very positive one, reflecting on the things that we've indicated matter. That speaks to how we go commercial and enable strong commercial launch momentum and velocity, here initially in the United States, and hopefully also as we're building the foundation in Europe.

Speaker #2: And having that occur at the same time we're enabling better information to inform patient and market access, and also preparing for what we hope will be an expanded label to include nHCM based on the ACACIA data.

Robert Blum: Having that occur at the same time we're enabling a better information to inform patient and market access, and also preparing for what we hope will be an expanded label to include NHCM based on the ACACIA data. I will remind you that we're going to have several presentations, including hotline presentation at ESC later this month.

Speaker #2: I'll remind you that we're going to have several presentations, including a hotline presentation at ESC later this month. And coming out of that, we'll also have an investor event that we look forward to communicating to you from Munich.

Robert Blum: Coming out of that, we will also have an investor event that we look forward to communicating to you from Munich. At the same time, advancing our pipeline. That's a key tenet and hallmark of how we see our business growing over time for the benefit of patients, science, and shareholders. With that, operator, we're going to bring this call to a conclusion, and we thank you very much for all of your time and attention today.

Robert Blum: Coming out of that, we will also have an investor event that we look forward to communicating to you from Munich. At the same time, advancing our pipeline. That's a key tenet and hallmark of how we see our business growing over time for the benefit of patients, science, and shareholders. With that, operator, we're going to bring this call to a conclusion, and we thank you very much for all of your time and attention today.

Speaker #2: And at the same time, advancing our pipeline—that's a key tenet and hallmark of how we see our business growing over time, for the benefit of patients, science, and shareholders.

Speaker #2: With that, operator, we're going to bring this call to a conclusion. And we thank you very much for all of your time and attention today.

Operator: Thank you. This concludes today's call. Thank you for attending. You may now disconnect.

Operator: Thank you. This concludes today's call. Thank you for attending. You may now disconnect.

Q2 2026 Cytokinetics Inc Earnings Call

Demo
CYTK

Cytokinetics

Earnings

Q2 2026 Cytokinetics Inc Earnings Call

CYTK

Thursday, August 6th, 2026 at 8:30 PM

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