PresentationMaxwell SkorEquity Analyst All right. Great. I'm Max Skor, a biotech analyst with Morgan Stanley. And before we get started, I'd like to read some quick disclosures. For important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative. And with that, I am happy to welcome the Cytokinetics team. With us today is Fady Malik, Head of R&D; Sung Lee, CF ...

Cytokinetics FY Conference Summary Company Overview - **Company**: Cytokinetics (NasdaqGS:CYTK) - **Event**: FY Conference held on September 09, 2025 Key Industry and Company Insights Aficamten Clinical Trial Results - **MAPLE-HCM Trial**: Aficamten demonstrated superior performance compared to metoprolol, a long-standing first-line therapy for hypertrophic cardiomyopathy (HCM) [2][3] - **Beta Blocker Performance**: The trial revealed that beta blockers not only underperformed but also deteriorated exercise capacity, raising questions about their continued use as a standard of care [3][5] - **KOL Feedback**: Key opinion leaders expressed concerns about the efficacy of beta blockers, indicating a potential shift in treatment paradigms for HCM [7][10] Regulatory and Approval Timeline - **PDUFA Date**: Anticipated at the end of 2025, with preparations for launch and potential approvals in Europe and China [4][16] - **Supplemental Application**: Plans to submit a supplemental application post-PDUFA for further elucidation of beta blocker effects [9] Market Dynamics and Commercial Strategy - **Market Penetration**: Approximately 10,000 cardiologists currently prescribe beta blockers, with a significant opportunity to convert them to Aficamten [10] - **Guideline Updates**: If Aficamten is added to treatment guidelines by 2027, it could significantly enhance market penetration and preference share [10][12] - **Patient Support Program**: A focus on building a robust patient support program to facilitate the transition from beta blockers to Aficamten [22][52] Competitive Landscape - **Camzyos (mavacamten)**: Insights from the Odyssey trial indicated that cardiac myosin inhibitors could positively impact HCM physiology, although statistical significance was not achieved [27][28] - **Differentiation from Camzyos**: Aficamten's dosing regimen and metabolic profile are expected to provide a competitive edge in the market [19][20] Pipeline and Future Catalysts - **Upcoming Trials**: Acacia trial results expected next year, with additional studies for omecamtiv mecarbil and AMBER in heart failure populations [44][45] - **Long-term Vision**: Aiming to expand the pipeline with new products and partnerships, particularly in the context of growing opportunities in China [48][49] Financial Position and Capital Allocation - **Cash Reserves**: Over $1 billion in cash at the end of Q2, with plans for strategic capital allocation towards Aficamten's launch and pipeline advancement [46][47] - **Potential Additional Capital**: Access to a $100 million term loan and an additional $175 million contingent on Aficamten's approval [47] Investor Sentiment and Company Outlook - **Positive Momentum**: The company is experiencing high energy and enthusiasm as it approaches the Aficamten launch, with a well-prepared commercial team and differentiated product profile [51][52] - **Market Opportunity**: The potential for Aficamten to address both obstructive and non-obstructive HCM is seen as a significant market opportunity, with a total addressable market of approximately 130,000 to 140,000 symptomatic patients [40][41] Additional Important Points - **Patient Journey**: Non-obstructive HCM patients often go undiagnosed until later stages, highlighting the need for improved diagnostic rates [31][32] - **Regulatory Interactions**: Ongoing productive discussions with the FDA regarding the REMS and labeling processes [17][18] This summary encapsulates the critical insights and strategic directions discussed during the Cytokinetics FY Conference, emphasizing the company's innovative approach to HCM treatment and its robust pipeline.

Key Takeaways Cytokinetics' aficamten beat metoprolol on all key efficacy measures in phase III MAPLE-HCM study.Aficamten improved exercise capacity, symptoms, and LVOT gradients in patients with obstructive HCM.FDA review of aficamten is underway with a target decision date now set for Dec. 26, 2025.Cytokinetics, Incorporated's ((CYTK) shares surged 40.4% on Sept. 2, driven by positive results from a phase III study on cardiovascular candidate aficamten.On Aug. 30, Cytokinetics presented primary results fr ...

Company Overview - Cytokinetics is participating in the Citi Biopharma Conference, indicating a significant event for the company [1] - Robert Blum serves as the President and CEO of Cytokinetics and is joined by a senior executive team [2] - Fady Malik, the Head of Research and Development, has been with the company since its launch in 1998 and is a physician scientist and cardiologist [3] - Sung Lee has been the Chief Financial Officer for approximately 16 months [4] - Isaac Ciechanover also joined around 16 months ago as the Chief Business Officer [5] Key Developments - The conference is described as a big day for Cytokinetics, suggesting important announcements or updates may be forthcoming [2] - The leadership team is preparing to present information about the company's progress and future plans [2]

Cytokinetics (CYTK) Conference Summary Company Overview - Cytokinetics is transitioning from R&D to commercialization, focusing on muscle biology and pharmacology related to cardiovascular and neuromuscular diseases [6][7] - The company has a strong leadership team with extensive experience in the industry [2][4][5] Key Developments - **Pipeline Overview**: Cytokinetics has developed a pipeline of potential medicines, particularly focusing on cardiac myosin modulation [8][9] - **Lead Compound**: Aficamten, a cardiac myosin inhibitor, is pending FDA review for obstructive hypertrophic cardiomyopathy (OHCM) with a PDUFA date set for December 26, 2025 [10] - **Recent Study Results**: Positive results from the MAPLE Phase III study were presented at the European Society of Cardiology, which may enable label expansion for aficamten [11][13] Market Strategy - Cytokinetics aims to build a specialty cardiology franchise, with multiple product launches anticipated over the coming years [13][16] - The company plans to leverage a concentrated customer segment with approximately 125 sales professionals in the U.S. and Europe [16] Financial Position - Cytokinetics reported approximately $1 billion in cash and investments as of Q2 [17][52] - The company has access to additional capital through loans from Royalty Pharma, totaling up to $425 million contingent on aficamten's approval [18][52][53] Competitive Landscape - The company acknowledges competition from Bristol Myers Squibb's mavacamten but believes aficamten's differentiated profile will drive adoption [20][27] - Current market penetration for cardiac myosin inhibitors is about 15% of the symptomatic diagnosed population in the U.S., indicating significant growth potential [27][28] Clinical Insights - Aficamten is designed for easy titration and has shown a favorable safety profile in clinical trials, which may enhance its appeal to physicians [22][23] - The company is optimistic about the potential for aficamten to become a first-line therapy for patients with OHCM, especially following the compelling data presented [34][36] Future Outlook - Cytokinetics is focused on expanding its pipeline and exploring partnerships to enhance its market presence [49][50] - The company is also preparing for the launch of omecamtiv mecarbil, which is undergoing a confirmatory study (COMET) to validate previous positive results [48] Conclusion - Cytokinetics is positioned for significant growth with a robust pipeline and a strategic focus on specialty cardiology, backed by a strong financial foundation and promising clinical data [19][52]

With a background as an RN and an MBA, Stephen analyzes healthcare and tech stocks through the lens of investment process design. His work is guided by his proprietary "Dizzy Framework," a system developed to counter common behavioral errors like chasing market noise or rigidly sticking to priors. By focusing on the quality and timing of information, the framework enforces a patient and disciplined approach, translating complex science and market dynamics into truly actionable theses. His influences include ...

Group 1 - PepsiCo shares increased by 5.8%, with activist investment firm Elliott Management holding $4 billion in shares [1] - Cytokinetics shares surged by 27.2% following significant efficacy results from clinical trials of aficamten in treating symptomatic obstructive hypertrophic cardiomyopathy patients [1] - Constellation Brands shares fell by 7.3% after the company lowered its full-year earnings guidance [1] - Beike shares rose by 2.1%, with multiple institutions reaffirming a "buy" rating post-earnings [1]

Cytokinetics (CYTK) Update / Briefing September 02, 2025 08:30 AM ET Company ParticipantsDiane Weiser - SVP - Corporate AffairsFady Malik - EVP - R&DPablo Garcia-Pavia - CardiologistCarolyn Ho - Medical Director - Cardiovascular Genetics CenterAhmad Masri - Head - Cardiomyopathy SectionDaniel Jacoby - VP - Clinical ResearchAnjali Owens - Cardiovascular FellowRobert I. Blum - CEO, President & DirectorDiane WeiserWelcome, everyone, and thanks for joining. I'm Diane Weiser, SVP, corporate affairs. We're please ...

Cytokinetics (CYTK) Update Summary Company Overview - **Company**: Cytokinetics (CYTK) - **Focus**: Development of aficamtan for the treatment of obstructive hypertrophic cardiomyopathy (OHCM) Key Industry Insights - **Industry**: Cardiovascular Medicine - **Event**: European Society of Cardiology (ESC) Conference Core Findings from the Call 1. **Presentation of Data**: Cytokinetics presented four oral presentations and one poster on aficamtan, with three publications in leading cardiac journals, emphasizing its potential as a treatment for OHCM [7][8][27] 2. **MAPLE HCM Study**: The Phase III trial compared aficamtan to metoprolol, showing aficamtan's superiority in improving exercise capacity and reducing symptoms [8][26] 3. **Efficacy Results**: - Aficamtan showed a mean increase in peak VO2 of 1.1 mL/kg/min, while metoprolol showed a mean decrease of 1.2 mL/kg/min, with a statistically significant difference of 2.3 mL/kg/min (p < 0.001) [21][26] - Aficamtan improved NT proBNP levels by 81% compared to baseline, while metoprolol's levels increased [24][26] 4. **Safety Profile**: Aficamtan was well tolerated with a low incidence of adverse events, contrasting with metoprolol, which had a higher rate of dose reductions due to side effects [25][26] 5. **Long-term Data**: Data from FORWEST HCM indicated sustained hemodynamic benefits and low incidence of new onset atrial fibrillation over a mean follow-up of 62 weeks [11][12] Implications for Treatment 1. **Shift in Treatment Paradigm**: The results challenge the long-standing use of beta blockers as first-line therapy for symptomatic obstructive HCM, suggesting aficamtan as a more effective alternative [8][31] 2. **Guideline Updates**: Anticipation of updates to clinical guidelines to incorporate findings from MAPLE HCM and other studies, with a focus on aficamtan as a first-line therapy [77][79] Additional Insights 1. **Expert Perspectives**: Panelists highlighted the importance of randomized clinical trials in reshaping treatment approaches and the surprising underperformance of beta blockers in the study [33][36] 2. **Future Studies**: Ongoing studies, including Acacia HCM, are expected to provide further insights into the efficacy of aficamtan in different patient populations [82] 3. **Regulatory Pathway**: Cytokinetics is preparing a supplemental NDA to include MAPLE HCM results in labeling following the potential approval of aficamtan [81][82] Conclusion - The data presented at the ESC conference significantly bolster the case for aficamtan as a first-line treatment for obstructive HCM, potentially leading to a paradigm shift in clinical practice and future treatment guidelines [26][31][81]

Core Insights - Aficamten demonstrates improved cardiac structure and function compared to metoprolol in patients with obstructive hypertrophic cardiomyopathy (HCM) as shown in the MAPLE-HCM study [1][2][4] - The annual incidence rate of atrial fibrillation (AF) with aficamten is reported at 1.5%, aligning with expected rates in HCM patient prediction models [1][8] - Long-term data supports the safety profile of aficamten, indicating no significant increase in AF risk and minimal clinical impact from new-onset AF [7][11][16] Company Overview - Cytokinetics is advancing aficamten, an investigational cardiac myosin inhibitor, currently under regulatory review in the U.S. with a target action date of December 26, 2025 [2][21] - The company is preparing for potential regulatory approvals and commercialization of aficamten following positive results from pivotal clinical trials [23] Clinical Data - The MAPLE-HCM study indicates aficamten's superiority over metoprolol in improving diastolic function and reducing left ventricular outflow tract (LVOT) obstruction [4][10] - In the FOREST-HCM study, long-term treatment with aficamten showed sustained hemodynamic benefits and a low incidence of new-onset AF [11][12] - Aficamten treatment resulted in significant improvements in patient-reported outcomes, including a 15-point increase in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score [13] Safety Profile - An integrated safety analysis across multiple trials indicates aficamten has a low incidence of adverse events, comparable to placebo and metoprolol [16] - The incidence of LVEF <50% was low, with no serious heart failure events reported [14][16] Upcoming Events - Cytokinetics will host an investor webcast on September 2, 2025, to discuss the primary results from MAPLE-HCM and other data presented at the European Society of Cardiology Congress 2025 [17]