Executive Summary

Q1 2024 printed immaterial revenue and a wider GAAP net loss as Cytokinetics remains pre-commercial; revenue fell to $0.84M and GAAP EPS was $(1.33), with cash and investments at $634.3M at quarter-end .
Operating drivers were as expected: R&D modestly higher on cardiac myosin inhibitor programs, G&A lower on reduced pre-commercial spend; no non-GAAP metrics were provided .
Strategic focus remains aficamten: management highlighted late-breaking SEQUOIA-HCM presentations (May 13), preparation for an NDA in Q3 2024 and MAA in Q4 2024, and commercial readiness activities (payer value narrative, patient support, specialty distribution) .
2024 guidance was last issued on Feb 27 and was not updated in Q1; management reiterated roughly two years of cash runway inclusive of Royalty Pharma capacity, supporting NDA/launch readiness and Phase 3 execution (MAPLE enrollment completion targeted Q3 2024) .

What Went Well and What Went Wrong

What Went Well
- Regulatory and data flow on aficamten progressing: late-breaking SEQUOIA-HCM primary and additional analyses at HFA 2024; rolling NDA submission planned Q3 2024; EMA MAA planned Q4 2024 .
- Commercial readiness advanced: payer clinical value proposition, payer engagement plans (pre-approval exchange beginning Q3), patient support and specialty distribution strategy, targeted hiring in US/EU .
- Pipeline momentum: CK‑586 Phase 1 topline supported Phase 2 HFpEF study (Q4 2024 start); CEDAR‑HCM initiated in pediatric oHCM; Japanese PK bridging study for aficamten initiated (June 17 PR) .
What Went Wrong
- Revenue declined YoY due to prior-year milestones (Ji Xing $2.5M) and higher collaboration revenue in 2023, highlighting ongoing dependence on partnership revenue pre-launch .
- Operating loss remained substantial given continued Phase 3 programs and commercial build, with net loss at $(135.6)M and high non-cash interest related to revenue participation obligations .
- Omecamtiv mecarbil EU path set back as the MAA was withdrawn after CHMP feedback, removing a potential nearer-term diversification lever .

Financial Results

Sequential and YoY performance

Metric	Q3 2023	Q4 2023	Q1 2024
Revenue ($M)	$0.38	$1.67	$0.84
R&D Expense ($M)	$82.53	$84.98	$81.57
G&A Expense ($M)	$40.11	$44.11	$45.50
Operating Loss ($M)	$(122.27)	$(127.42)	$(126.24)
Net Loss ($M)	$(129.42)	$(136.90)	$(135.64)
Diluted EPS ($)	$(1.35)	$(1.38)	$(1.33)

YoY for the quarter

Metric	Q1 2023	Q1 2024
Revenue ($M)	$4.61	$0.84
R&D Expense ($M)	$79.42	$81.57
G&A Expense ($M)	$49.67	$45.50
Net Loss ($M)	$(131.29)	$(135.64)
Diluted EPS ($)	$(1.38)	$(1.33)

Drivers and KPIs

KPI	Q3 2023	Q4 2023	Q1 2024
Cash, Cash Equivalents & Investments ($M)	$554.7	$655.4	$634.3
Cash & ST Investments ($M, BS)	$539.24	$614.82	$618.96
Weighted Avg Shares (M)	96.07	99.07	101.92

Notes: Revenue decline vs Q1’23 reflects absence of $2.5M Ji Xing milestone and lower collaboration revenue; R&D up modestly on cardiac myosin inhibitor programs; G&A down on lower pre-commercial outside spend .

Segment breakdown: Not applicable (no reportable segments) .

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Revenue ($M)	FY 2024	$3–$5 (2/27/24)	No update provided in Q1 materials	No update
Operating Expenses ($M)	FY 2024	$420–$450 (2/27/24)	No update provided in Q1 materials	No update
Net Cash Utilization ($M)	FY 2024	$390–$420 (2/27/24)	No update provided in Q1 materials	No update
Cash Runway	~2 years (as of 12/31/23 incl. ATM/Royalty Pharma capacity)	~2 years (as of 3/31/24 incl. Royalty Pharma capacity)	No update

Management did not explicitly reaffirm the numeric ranges during Q1; they reiterated ~2 years of runway and highlighted potential diversified, largely non-dilutive capital access .

Earnings Call Themes & Trends

Topic	Previous Mentions (Q3’23 and Q4’23)	Current Period (Q1’24)	Trend
Regulatory (NDA/MAA) & REMS	Q4: met FDA in Feb ahead of NDA; plan NDA Q3’24, MAA Q4’24 .	Type B meeting in Q2 on risk mitigation; pursuing differentiated risk strategy (notably vs ETASU precedent) .	Increasing clarity; risk-mitigation differentiation emphasized.
SEQUOIA-HCM data/pubs	Q3: topline due late Dec ; Q4: positive topline; primary results to be presented Q2’24 .	Three late-breakers (primary + dosing/safety + CPET deep-dive) at HFA May 13; more presentations/publications through 2024 .	Evidence build accelerating.
Commercial readiness	Q3: advancing go-to-market ; Q4: payer value proposition, specialty channels engagement .	Market development campaign, patient support, specialty distribution, payer dialogues and pre-approval information exchange from Q3 .	Execution progressing.
MAPLE-HCM (oHCM monotherapy vs metoprolol)	Continuing enrollment .	Enrollment completion expected Q3’24; readout in 2025; potential to inform first-line positioning .	On track; strategic for guidelines.
ACACIA-HCM (nHCM)	Initiated/continuing enrollment .	Global activation/enrollment continues through 2024; completion targeted 2025 .	Steady progress.
CK‑586 (HFpEF)	Progressed to MAD cohorts ; Q4: Phase 1 data expected Q2’24 .	Phase 1 topline supports Phase 2 start Q4’24; goal of simpler dosing vs aficamten .	Advancing to Phase 2.
Omecamtiv mecarbil	Q3: FDA dispute/EMA review ongoing .	Withdrew EMA MAA after CHMP feedback .	Deprioritized.
Japan strategy	—	Phase 1 PK bridging study in Japanese/Caucasian participants initiated (June 17) .	Foundation for Japan registration.
Guidelines/payer landscape	—	New AHA/ACC HCM guideline dropped; class-level framing; payer/HTA outlook improving for CMI class (Germany/France/UK) .	Constructive backdrop.

Management Commentary

“We are laser-focused on regulatory submissions in the second half of the year... and accelerating our commercial readiness activities” (CEO) .
“Our position is that the benefit/risk profile of aficamten merits an approach to risk mitigation that's reflective of the safety profile... demonstrated in SEQUOIA‑HCM and FOREST‑HCM” (EVP R&D) .
“Beginning in Q3... we plan to initiate preapproval information exchange with every major payer to review the results of SEQUOIA‑HCM” (Chief Commercial Officer) .
“We ended the quarter with approximately $634.3 million of cash... which represents 2 years of forward cash runway, including capital we expect... under our deal with Royalty Pharma” (Chief Accounting Officer) .
“We’re prepared to execute on a series of primarily non-dilutive transactions... to lower our overall cost of capital” (CEO) .

Q&A Highlights

Risk mitigation/REMS: Management expects a differentiated REMS approach versus existing ETASU precedent, informed by aficamten’s PK/PD, half-life, DDI, and EF excursion profile; details to be shaped with FDA and reflected in NDA strategy .
NDA content: While MAPLE remains blinded, NDA review will include a 120‑day safety update aggregating ongoing trial data (MAPLE, ACACIA, FOREST) to further substantiate safety .
Competitive dynamics: Strategy is category expansion, not switching from mavacamten; switching would be a physician-patient decision rather than a marketed message .
CK‑586 (HFpEF): Designed to enable simpler dosing than aficamten and to target a vulnerable HFpEF subset (high EF, wall thickening, severe diastolic dysfunction); echo monitoring may not be required pending data .
Market sizing and pediatrics: ~200k diagnosed oHCM patients in the US (~130k NYHA II/III eligible), true prevalence likely 3–4x; peds HCM ~6–8k diagnosed across US/EU, with 50–60% potentially eligible .

Estimates Context

We attempted to retrieve S&P Global consensus for Q1 2024 revenue and EPS, the prior quarter, and the next quarter, but the request was rate-limited and consensus figures were unavailable at this time. As a result, we cannot quantify beats/misses versus S&P Global consensus for Q1 2024 actuals [GetEstimates error].
Implication: With minimal reported revenue and a known negative EPS profile pre-commercialization, estimate dispersion is typically driven by operating expense and non-cash interest assumptions; investors should monitor revisions following HFA/SEQUOIA data and NDA clarity.

Key Takeaways for Investors

Aficamten remains the core value driver; late-breaking SEQUOIA-HCM datasets and rolling NDA (Q3’24) should be the primary stock catalysts near term, with MAA (Q4’24) and MAPLE enrollment completion (Q3’24) as secondary catalysts .
Risk mitigation strategy appears differentiated; clarity from the Type B meeting could de-risk REMS burden—a key launch/pricing and uptake consideration relative to the class .
Commercial readiness is progressing (payer narrative, pre-approval exchange in Q3, patient support, specialty distribution), targeting a concentrated prescriber base in specialty cardiology .
Balance sheet supports execution through critical milestones (~$634.3M cash/investments; ~2 years runway with Royalty Pharma capacity), with intent to pursue largely non-dilutive capital and Japan partnering .
CK‑586 is a real option on HFpEF with differentiation aims (simpler dosing; vulnerable subset focus); Phase 2 initiation in Q4’24 is another medium-term pipeline catalyst .
Omecamtiv’s EU withdrawal removes one diversification path but also streamlines focus on aficamten; watch for guideline evolution and payer HTA updates to frame launch trajectory .

Appendix: Additional Data Tables

Consensus vs Actual (Q1 2024)

Metric	Q1 2024 Actual	S&P Global Consensus	Surprise
Revenue ($M)	$0.84	Unavailable	N/A
Diluted EPS ($)	$(1.33)	Unavailable	N/A

Operating Expense Detail (Q1 YoY)

Metric	Q1 2023	Q1 2024	Commentary
R&D ($M)	$79.42	$81.57	Higher on cardiac myosin inhibitor programs
G&A ($M)	$49.67	$45.50	Lower on reduced pre-commercial outside spending

Pipeline and Corporate Milestones (selection)

Aficamten: Late-breakers at HFA May 13 (primary + dosing/safety + CPET analyses) ; NDA Q3’24; MAA Q4’24 .
MAPLE‑HCM: Enrollment completion expected Q3’24; readout 2025 .
ACACIA‑HCM: Enrollment throughout 2024; completion 2025 .
CEDAR‑HCM: Pediatric oHCM trial initiated .
CK‑586: Phase 1 topline supports Phase 2 start Q4’24 .
Japan bridge: Phase 1 Japanese/Caucasian PK study initiated (June 17 PR) .

Sources: CYTK Q1 2024 8‑K and press release -; Q1 2024 earnings call transcript -; Q4 2023 8‑K and press release -; Q3 2023 8‑K and press release -; June 17, 2024 press release -.

CYTOKINETICS INC (CYTK)·Q1 2024 Earnings Summary