Cytokinetics Q4 net loss $137.4M; FDA rejects omecamtiv mecarbil NDA

CYTOKINETICS INC

2022-FY EPS reported -$4.33 revenue$94,588,000

Net loss Q4 2022 $137.4M ($1.45/share) vs $30.6M ($0.36/share) in Q4 2021; full year loss $389.0M ($4.33/share).
FDA issued Complete Response Letter for omecamtiv mecarbil NDA, citing insufficient evidence from GALACTIC-HF.
Cash, cash equivalents and investments $829.3M at Dec 31, 2022; 2023 guidance: revenue up to $5M, operating expenses $420-450M.
SEQUOIA-HCM (aficamten) enrollment complete in Q2 2023 with results expected Q4 2023; second interim analysis of COURAGE-ALS in Q2 2023.
R&D expenses $75.0M in Q4 2022, up from $43.5M in Q4 2021; G&A $54.0M vs $33.8M.

item 2.02 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 1.0

CYTOKINETICS INC reported the fourth quarter and full year 2022 results: net income Net loss for the fourth quarter was $137.4 million or $1.45 per share and the net loss for the year 2022 was $389.0 mill.

Period: the fourth quarter and full year 2022
Net income: Net loss for the fourth quarter was $137.4 million or $1.45 per share and the net loss for the year 2022 was $389.0 mill
Result: reported results

Exact text from the filing

On March 1, 2023, Cytokinetics, Incorporated announced its financial results for the fourth quarter and for the year ended December 31, 2022.

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Source: SEC EDGAR

accession 0000950170-23-005503

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