The earnings call highlighted significant regulatory progress and strategic partnerships for aficamten, a strong financial position, and pipeline advancements. However, increased expenses and ongoing regulatory challenges were noted. Despite these challenges, the progress and strategic moves position the company well for future growth.
Company Guidance
During Cytokinetics' Fourth Quarter 2024 Conference Call, several key metrics and updates were shared. The company highlighted that their NDA for aficamten was accepted by the FDA with a PDUFA date of September 26, 2025, and the MAA was validated by the EMA, with priority review given in China. They are preparing for potential commercial launches across multiple geographies, including the U.S. and Europe, and have ongoing regulatory interactions. Financially, Cytokinetics ended the quarter with $1.2 billion in cash and investments, and they expect 2025 GAAP operating expenses to range between $670 million and $710 million. The company's R&D expenses for Q4 2024 were $93.6 million, and G&A expenses were $62.3 million. Additionally, Cytokinetics is advancing its clinical programs with MAPLE-HCM, ACACIA-HCM, and COMET-HF, and has formed strategic partnerships with Sanofi and Bayer to expand aficamten's global reach. They also launched an unbranded disease awareness campaign, "HCM Beyond The Heart," to increase awareness of hypertrophic cardiomyopathy (HCM).
Regulatory Progress for Aficamten
NDA accepted by FDA, MAA validated by EMA, and NDA accepted by NMPA in China with priority review. Engaging in parallel regulatory interactions for potential global approvals.
Strategic Partnerships
Entered a collaboration with Bayer for aficamten in Japan, securing EUR50 million upfront and potential EUR490 million in commercial milestone payments. Additionally, Sanofi acquired rights to aficamten in China.
Financial Strength
Ended Q4 2024 with $1.2 billion in cash and investments. Generated $16.9 million in revenue in Q4 2024, a significant increase from $1.7 million in Q4 2023.
Pipeline Advancements
Started COMET-HF Phase 3 trial for omecamtiv mecarbil and AMBER-HFpEF Phase 2 trial for CK-586. Initiated Phase 1 study for CK-089, a neuromuscular disease candidate.
---
Cytokinetics (CYTK) Earnings, Revenues Date & History
The upcoming earnings date is based on a company’s previous reporting, and may be updated when the actual date is announced
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
---
CYTK Earnings-Related Price Changes
Report Date
Price 1 Day Before
Price 1 Day After
Percentage Change
Feb 27, 2025
$47.45
$46.00
-3.06%
Nov 06, 2024
$55.50
$55.84
+0.61%
Aug 08, 2024
$54.00
$55.79
+3.31%
May 08, 2024
$65.27
$64.02
-1.92%
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
---
FAQ
When does Cytokinetics (CYTK) report earnings?
Cytokinetics (CYTK) is schdueled to report earning on May 01, 2025, TBA Not Confirmed.
What is Cytokinetics (CYTK) earnings time?
Cytokinetics (CYTK) earnings time is at May 01, 2025, TBA Not Confirmed.
Where can I see when companies are reporting earnings?
You can see which companies are reporting today on our designated earnings calendar.