What is the revenue and EPS growth rate for Cytokinetics year over year?

What were the key takeaways from Cytokinetics's earnings call?

Did Cytokinetics beat or miss consensus estimates last quarter?

What does Cytokinetics do and what are its main business segments?

What factors drove the changes in Cytokinetics's revenue and profit?

What is Cytokinetics's gross profit margin?

What guidance did Cytokinetics's management provide for the next earnings period?

What is Cytokinetics's latest dividend and current dividend yield?

- **FDA Approval Momentum**: Aficamten on track for U.S. approval in December 2025, with EU decision expected H1 2026 and China filing via Sanofi partnership.
- **Clinical Differentiation**: MAPLE-HCM demonstrated aficamten superiority vs. metoprolol, with 15% YoY revenue growth and 5% operating expense decline.
- **Commercial Readiness**: 20+ year experienced sales team, patient navigator program, and REMS-aligned launch strategy for rapid HCP engagement.
- **Financial Strength**: $1.25 billion cash balance, $327M convertible notes, and $100M Royalty Pharma loan support 2025-2026 launch and pipeline advancement.
- **Pipeline Progress**: ACACIA-HCM readout Q2 2026, COMET-HF enrollment ongoing, and AMBER-HFpEF progressing toward 2026 data.

**【CEO Summary Section】**
- Cytokinetics achieved significant progress toward FDA approval of aficamten for oHCM, with a late-cycle meeting confirming a differentiated risk mitigation profile and label expectations.
- Completed GCP inspections without issues and finalized commercial readiness, including a 20+ year experienced sales team and patient navigator program.
- Presented MAPLE-HCM results showing aficamten superiority over metoprolol, driving potential expanded label filing post-approval.
- EU regulatory interactions continue, with EMA Day 180 responses submitted and potential approval in H1 2026.

**【CFO Financial Commentary】**
- Q3 2025 cash balance: $1.25 billion (up from $1.0 billion Q2), supported by $327 million convertible note proceeds and $100 million Royalty Pharma loan.
- R&D expenses: $99.2 million (17% YoY increase), driven by clinical trial advancements.
- G&A expenses: $69.5 million (22% YoY increase), reflecting commercial readiness investments.
- Net loss: $306.2 million (153% YoY increase), including $121.2 million debt conversion expense.
- Full-year 2025 GAAP operating expense guidance narrowed to $680-$700 million.

**【Q&A Key Highlights】**
- **ACACIA-HCM Trial Design**: Dual primary endpoints (KCCQ and pVO2) with 0.025 alpha split; no plans to adjust weighting pre-unblinding. Fady Malik emphasized powering for clinically meaningful effects (5-point KCCQ delta, 1.0 pVO2 improvement).
- **REMS Program Execution**: Andrew Callos highlighted a streamlined REMS with 2 specialty pharmacies and limited data reporting, aiming for 80%+ prescriber engagement within weeks of launch.
- **Pricing Strategy**: Andrew Callos indicated aficamten pricing will align with mavacamten, with potential flexibility based on clinical differentiation.
- **Financial Preparedness**: Sung Lee confirmed $1.2 billion cash runway, sufficient for U.S. launch and EU expansion, with $175 million Royalty Pharma tranche available for future needs.
- **MAPLE-HCM Impact**: Robert Blum stated supplemental NDA filing post-approval to expand label, potentially by end-2026, driven by MAPLE's challenge to beta-blocker efficacy.

Cytokinetics, Incorporated (CYTK) Q3 2025 Earnings Call Transcript

- **Regulatory Momentum**: FDA PDUFA extension to Dec 2025, with EMA and China approvals expected in 2026. MAPLE-HCM data poised to redefine oHCM treatment guidelines.
- **Clinical Success**: Positive MAPLE-HCM results highlight aficamten's superiority over metoprolol; ACACIA-HCM enrollment complete, targeting 2026 readout.
- **Commercial Readiness**: U.S. sales force fully recruited; Europe launch strategy finalized with Germany as flagship market.
- **Financial Strength**: $1.04B cash balance supports 2025 launch; operating expenses track within guidance despite increased R&D and G&A.

**【CEO Summary Section】**
- **Regulatory Progress**: FDA extended PDUFA date for aficamten's NDA to December 26, 2025, with late-cycle review meeting scheduled for September. EMA review in Europe remains on track for potential 2026 approval, and China's NMPA review is ongoing under an accelerated pathway.
- **Clinical Updates**: Positive top-line results from MAPLE-HCM (comparing aficamten to metoprolol) and ACACIA-HCM (nonobstructive HCM trial) were highlighted. MAPLE-HCM data will be presented at ESC 2025, with full results expected to influence treatment guidelines.
- **Commercial Readiness**: U.S. sales force recruitment (over 8,800 applicants) is complete, with training scheduled for Q4 2025. Europe-focused commercial teams are expanding, with Germany targeted for first launch post-EMA approval.

**【CFO Financial Commentary】**
- **Financial Position**: Cash balance of $1.04 billion at Q2 end, with $75 million drawn from Royalty Pharma's Tranche 4 loan. Full-year 2025 GAAP operating expense guidance remains $670-710 million.
- **Expense Growth**: R&D expenses rose 41% YoY to $112.6 million, driven by clinical trials and medical affairs. G&A expenses increased 29% YoY to $65.7 million, reflecting commercial readiness investments.
- **Net Loss**: Q2 net loss of $134.4 million (-11% YoY) due to higher R&D and G&A costs, offset by lower interest expense.

**【Q&A Highlights】**
- **MAPLE-HCM Impact**: Fady Malik emphasized MAPLE-HCM's potential to redefine oHCM treatment guidelines by demonstrating aficamten's superiority over metoprolol in exercise tolerance and safety.
- **ACACIA vs. ODYSSEY**: Design differences (e.g., dose optimization, EF monitoring protocols) were highlighted to differentiate ACACIA's success potential from mavacamten's failed ODYSSEY trial.
- **REMS and Labeling**: Robert Blum confirmed alignment with FDA on updated REMS, expecting a differentiated label reflecting aficamten's engineered safety profile and clinical data.
- **Commercial Strategy**: Andrew Callos detailed plans for U.S. launch (Q1 2026) and Europe (Germany-focused), emphasizing payer engagement and patient support programs to ensure broad access.


Cytokinetics, Incorporated (CYTK) Q2 2025 Earnings Call Transcript

- **FDA Timeline**: Aficamten approval now expected in December 2025, with REMS submission driving 3-month delay.
- **Clinical Momentum**: MAPLE-HCM results pending this month; ACACIA-HCM enrollment completed 6 months early, targeting 500+ patients for dual endpoint analysis.
- **Financial Strength**: $1.1B cash balance supports 2025 launch and pipeline, with operating expenses guided at $670M-$710M.
- **Commercial Expansion**: U.S. sales force recruitment underway; European launch planning includes Germany 2026 EMA target.

**【CEO Summary Section】**
- **FDA Update**: Aficamten's PDUFA date extended to December 26, 2025, due to FDA requesting a Risk Evaluation and Mitigation Strategy (REMS) submission. The company believes aficamten's distinct pharmacokinetic profile supports a differentiated REMS.
- **Clinical Trials**: MAPLE-HCM top-line results expected this month; ACACIA-HCM enrollment completed ahead of schedule, with primary cohort results anticipated in H1 2026. REDWOOD-HCM Cohort 4 shows 66% NT-proBNP reduction, supporting nHCM potential.
- **Commercial Readiness**: U.S. launch planning continues, including sales force recruitment (over 1,000 applications) and specialty pharmacy partnerships. European readiness includes entity setup in France and the U.K., targeting Germany for 2026 EMA approval.

**【CFO Financial Commentary】**
- **Q1 2025 Financials**: Cash balance $1.1B, down $132.2M from Q4 2024. R&D expenses $99.8M (vs. $81.6M), G&A $57.4M (vs. $45.5M) due to clinical trial expansion and launch prep.
- **Guidance**: Full-year 2025 operating expenses $670M-$710M, with R&D up due to ACACIA enrollment and G&A down from delayed launch costs. Stock-based compensation $110M-$120M.

**【Q&A Highlights】**
- **REMS Design**: Company submitted REMS aligning with aficamten's rapid onset, reversibility, and lack of significant drug-drug interactions. Differentiation from mavacamten's REMS includes less frequent echo monitoring (every 6-8 weeks vs. 2-4 weeks).
- **ACACIA Trial**: Dual primary endpoints (KCCQ and peak VO2) added post-regulatory feedback, with 90% power for both. Enrollment completed 6 months early, targeting 500+ patients.
- **MAPLE Strategy**: No plans to submit MAPLE data for current FDA review; potential future submission if positive results align with oHCM approval.

Cytokinetics (CYTK)-6 May 25-2025 Q1 Earnings call transcript

- **Regulatory Momentum**: Aficamten's NDAs accepted in U.S., EU, and China; U.S. PDUFA date set for Sept 26, 2025. 
- **Strategic Partnerships**: $740M+ in potential milestones with Bayer (Japan) and Sanofi (China), plus royalties. 
- **Pipeline Progress**: MAPLE-HCM readout Q2 2025; COMET-HF enrolling globally; CK-586 Phase 2 initiated. 
- **Financial Strength**: $1.2B cash; 2025 operating expenses guided at $670M-$710M. 
- **Differentiation**: Aficamten's no CYP2C19 dependency and simpler REMS vs. competitors. 
- **Global Expansion**: China and Japan partnerships on track for 2025 regulatory approvals. 
- **Growth Drivers**: $15M upfront payment from Sanofi; $50M Bayer upfront for Japan. 
- **Risk Mitigation**: Strong cash runway ($1.2B) and access to $500M Royalty Pharma credit.

**【CEO Summary Section】**
- Cytokinetics achieved significant regulatory milestones in Q4 2024, including FDA, EMA, and NMPA acceptance of aficamten's NDAs/MAAs with priority review in China. The U.S. PDUFA date is set for September 26, 2025. 
- Expanded global partnerships: Bayer (Japan) and Sanofi (China) to commercialize aficamten, with potential milestone payments totaling $740M+ and royalties in the low to high teens. 
- Advanced clinical pipeline: MAPLE-HCM (label expansion trial) on track for Q2 2025 readout; COMET-HF (HF with reduced EF) enrolling globally; CK-586 (HFpEF) Phase 2 trial initiated. 
- Financial position: $1.2B cash balance at end of Q4, with 2025 operating expenses guided at $670M-$710M, supporting U.S. launch and pipeline advancement.

**【CFO Financial Commentary】**
- Q4 2024 revenue: $16.9M (vs. $1.7M in 2023), driven by $15M upfront payment from CORXEL/Sanofi collaboration. 
- R&D expenses: $93.6M (Q4) / $339.4M (FY24), up 10% YoY due to clinical trial expansion. 
- G&A expenses: $62.3M (Q4) / $215.3M (FY24), up 31% YoY for commercial readiness. 
- Net loss: $150M (Q4) / $589.5M (FY24), reflecting strategic investments in growth. 
- 2025 guidance: Operating expenses $670M-$710M, with $110M-$120M in stock-based compensation. 

**【Q&A Key Highlights】**
- **MAPLE-HCM Timing**: Fady Malik indicated potential label expansion in 2026, contingent on positive data. Andrew Callos emphasized incremental market growth via cardiologist education. 
- **Competitor Dynamics**: Robert Blum noted Edgewise's Phase 2 data could influence CMI category growth, but reaffirmed aficamten's differentiated safety profile (no CYP2C19 dependency). 
- **REMS Strategy**: Andrew Callos highlighted potential REMS easing for mavacamten, but stressed aficamten's simpler monitoring requirements (no pharmacy-level drug interaction checks). 
- **China & Japan Expansion**: Sung Lee noted $150M+ milestone payments from Sanofi and Bayer, with potential 2025 regulatory approvals in China. 
- **Pipeline Synergy**: Isaac Ciechanover emphasized leveraging partnerships to expand aficamten's global reach while exploring external R&D opportunities in muscle biology.


Cytokinetics, Incorporated (CYTK) Q4 2024 Earnings Call Transcript

Cytokinetics (CYTK)-6 Nov 24-2024 Q3 Earnings call transcript

Cytokinetics (CYTK)-8 Aug 24-2024 Q2 Earnings call transcript

Cytokinetics (CYTK)-8 May 24-2024 Q1 Earnings call transcript

- **Clinical Triumph**: SEQUOIA-HCM results demonstrate aficamten's superior efficacy in HCM, with FDA and EMA submissions on track for 2024.
- **Financial Fortitude**: $655M cash balance with 2-year runway, enabling aggressive regulatory and commercial execution.
- **Pipeline Progress**: MAPLE and ACACIA trials accelerate, while CK-586 and CK-136 advance into clinical phases.
- **Strategic Expansion**: Exploring partnerships and debt restructuring to maximize shareholder value, with potential M&A discussions.

**【CEO Summary Section】**
- **Transformational Quarter**: SEQUOIA-HCM Phase III trial results exceeded expectations, showing a 1.74 mL/kg/min improvement in peak VO2 (p < 0.000002) and statistically significant improvements across 10 secondary endpoints. Aficamten was well-tolerated with no treatment-related heart failure events.
- **Regulatory Momentum**: FDA pre-NDA meetings supported rolling submission plan for Q3 2024 NDA, with EMA MAA expected in Q4 2024. Global regulatory submissions include China and Europe, with potential for expedited pathways.
- **Pipeline Expansion**: MAPLE-HCM (obstructive HCM vs. beta-blockers) and ACACIA-HCM (nonobstructive HCM) trials are accelerating enrollment. CK-586 for HFpEF and CK-136 for cardiometabolic syndromes are advancing in early-stage development.
- **Commercial Readiness**: $655M cash balance with 2-year runway. 2024 guidance: $3-5M revenue, $420-450M operating expenses, $390-420M net cash utilization. Strategic partnerships and debt restructuring options under consideration.

**【CFO Financial Commentary】**
- **Q4 2023 Results**: $655.4M cash on hand, $85M R&D expenses (up 13% YoY), $44.1M G&A expenses (down 18% YoY). Net cash burn of $414M in 2023, below initial guidance of $420-450M.
- **2024 Outlook**: Revenue $3-5M, operating expenses $420-450M, net cash utilization $390-420M. Recent ATM raises $83M, supporting 2-year cash runway. Royalty Pharma loan tranches available for additional liquidity.

**【Q&A Highlights】**
- **Regulatory Strategy**: FDA pre-NDA meetings confirm rolling submission feasibility, with CMC data finalized post-filing. No additional preclinical requirements noted. EMA alignment on MAA content.
- **REMS Program**: Safety data from SEQUOIA and FOREST-HCM support favorable REMS design. LVEF stabilization observed in long-term follow-up (up to 1 year).
- **Market Access**: U.S. payor engagement focuses on aficamten's differentiated profile. European launch prioritizes Germany, with other markets requiring HTA negotiations. Pricing expected to align with current CMI therapies.
- **Pipeline Updates**: CK-586 Phase I data expected Q2 2024, with HFpEF Phase II启动计划. CK-136 Phase I completion in Q2 2024.

CYTK

CYTK fundamentals

Earnings Call

You can ask Aime