Cytokinetics 2021 results and 2022 outlook

 Commercial Launch Readiness Activities Underway for Omecamtiv Mecarbil in Advance of PDUFA Date of November 30, 2022

SEQUOIA-HCM Open to Enrollment;
Development Program for Aficamten Expanding in 2022

Company Provides 2022 Financial Guidance;
More Than 2 Years of Cash Runway

2022 Corporate Milestones

Cardiac Muscle Programs

omecamtiv mecarbil (cardiac myosin activator)

• Launch omecamtiv mecarbil in the U.S. pending FDA approval in Q4 2022.
  

aficamten (cardiac myosin inhibitor)

• Continue enrollment in SEQUOIA-HCM through 2022.
  
  

• Begin enrolling patients with non-obstructive HCM in Cohort 4 of REDWOOD-HCM in Q1 2022.
  
  

• Begin second Phase 3 clinical trial of aficamten in obstructive HCM in 2H 2022.
  
  

• Expect to share data from the open label extension study, REDWOOD-HCM OLE, for patients who complete REDWOOD-HCM, in 2022.
  

CK-3828136 (CK-136) (cardiac troponin activator)

• Reactivate development program for CK-136 in 2H 2022.
  

Skeletal Muscle Program

reldesemtiv (fast skeletal muscle troponin activator (FSTA))

• Expect the Data Monitoring committee to conduct the first interim analysis from COURAGE-ALS in 2H 2022, assessing for futility, 12 weeks after approximately one-third or more of the planned sample size is randomized.
  

Financials

Revenues for the three and twelve months ended December 31, 2021 were $55.6 million and $70.4 million, respectively, compared to $6.7 million and $55.8 million for the corresponding periods in 2020. The increase in revenues for the year ended December 31, 2021 was primarily due to $54.9 million of license revenue recognized for the transaction with Ji Xing.

Research and development expenses for the three and twelve months ended December 31, 2021 increased to $43.5 million and $159.9 million, respectively, compared to $29.2 million and $97.0 million for the same periods in 2020, respectively, due primarily to increases in spending for clinical development activities for our cardiac muscle inhibitor programs, COURAGE-ALS, facility expenses and for regulatory filing costs. In addition, we incurred transition costs related to the termination of our collaboration with Amgen and our purchase of approximately $14.6 million of material including manufactured quantities of the active pharmaceutical ingredients for omecamtiv mecarbil.

General and administrative expenses for the three and twelve months ended December 31, 2021 increased to $33.8 million and $96.8 million from $13.9 million and $52.8 million in 2020 due primarily to higher outside services spending in anticipation of the potential commercial launch of omecamtiv mecarbil, an increase in personnel related costs including stock-based compensation and facilities expenses for our new headquarters.

2022 Financial Guidance

The company today announced financial guidance for 2022. The company anticipates revenue will be in the range of $20 to $25 million, operating expenses will be in the range of $380 to $400 million, and net cash utilization will be approximately $365 to $385 million. Our current cash balance of $724 million, in addition to committed capital expected to be earned upon dosing of the first patient in SEQUOIA-HCM, represents more than two years of forward cash based on our projected operating expenses and net cash utilization.

Conference Call and Webcast Information

Members of Cytokinetics’ senior management team will review the company’s fourth quarter results on a conference call today at 4:30 PM Eastern Time. The call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 2895984.

An archived replay of the webcast will be available via Cytokinetics’ website until March 10, 2022. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 2895984 from February 24, 2022 at 7:30 PM Eastern Time until March 10, 2022.

https://finance.yahoo.com/news/cytokinetics-reports-fourth-quarter-2021-210000775.html