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Jun 30, 2022
Cytokinetics Q2 2022 Earnings Report
Reported financial results for the second quarter of 2022 and revised 2022 financial guidance, reducing projected spending.
Key Takeaways
Cytokinetics reported a net loss of $19.8 million for Q2 2022, with cash, cash equivalents, and investments totaling $596.7 million as of June 30, 2022. The company revised its 2022 financial guidance, anticipating operating expenses between $375 to $385 million and expects to end the year with over $800 million in cash.
Net loss for the second quarter was $19.8 million, or $0.23 per share.
Cash, cash equivalents and investments totaled $596.7 million at June 30, 2022.
The FDA plans to convene an Advisory Committee meeting to review the NDA for omecamtiv mecarbil on December 13, 2022.
The company anticipates operating expenses for 2022 will be in the range of $375 to $385 million.
Cytokinetics
Cytokinetics
Forward Guidance
The company revised its financial guidance related to a reduction in expected operating expenses as a result of the three-month extension of the PDUFA date for omecamtiv mecarbil to February 28, 2023.
Positive Outlook
- Participate in Advisory Committee meeting to review the NDA for omecamtiv mecarbil on December 13, 2022.
- Launch omecamtiv mecarbil in the U.S. subject to FDA approval in Q1 2023.
- Continue enrolling patients with obstructive HCM in SEQUOIA-HCM through 2022 with results expected in 2H 2023.
- Continue enrolling patients with non-obstructive HCM in Cohort 4 of REDWOOD-HCM with results expected in 1H 2023.
- Begin second Phase 3 clinical trial of aficamten in obstructive HCM in Q4 2022.
Challenges Ahead
- The company revised its financial guidance related to a reduction in expected operating expenses as a result of the three-month extension of the PDUFA date for omecamtiv mecarbil to February 28, 2023, which shifted certain hiring and activities previously planned to occur in 2022 to 2023.
- The company anticipates operating expenses for 2022 will be in the range of $375 to $385 million.
- Net cash utilization will be approximately $360 to $365 million.
- The company expects to end 2022 with more than $800 million, representing between two and three years of forward cash.
- The FDA extended the Prescription Drug User Fee Act (PDUFA) date for omecamtiv mecarbil to February 28, 2023 due to additional pharmacokinetic analyses of omecamtiv mecarbil provided to the FDA upon request and that are deemed to constitute a major amendment to the NDA.