On February 24, 2022 Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the fourth quarter and full year 2021 (Press release, Cytokinetics, FEB 24, 2022, View Source [SID1234609068]). Net loss for the fourth quarter was $30.6 million or $0.36 per share and the net loss for the year 2021 was $215.3 million or $2.80 per share. Net loss for the fourth quarter of 2020 was $43.9 million or $0.62 per share and net loss for the year 2020 was $127.3 million or $1.97 per share. Cash, cash equivalents and investments totaled $623.7 million at December 31, 2021. This cash balance does not include $150 million in proceeds received from transactions executed in late 2021 and early 2022.
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"In the fourth quarter of last year and in early January we were pleased to execute two important transactions, comprising the licensing of omecamtiv mecarbil in China as well as funding for long-term capital supportive of the commercial launch of omecamtiv mecarbil and the further development of aficamten. In the fourth quarter we also continued to build our commercial infrastructure remaining prudent to spending gated to key de-risking events, such as the recent acceptance of the New Drug Application for omecamtiv mecarbil by the U.S. Food and Drug Administration," said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. "As we look ahead to what may be a pivotal year for our company, we believe that we are in a strong financial position to expand the development program for aficamten and advance our pipeline of early drug candidates while we also deliver on the promise of muscle biology by responsibly transforming from a R&D focused company to one that is also commercial."
Q4 and Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
The U.S. Food and Drug Administration (FDA) accepted and filed our New Drug Application (NDA) for omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction (HFrEF). The NDA was assigned standard review with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2022.
Continued building our commercial infrastructure and capabilities and engaged in product launch readiness activities for omecamtiv mecarbil in the U.S. Key launch readiness activities in Q4 focused to market access, distribution strategy, campaign development, pricing, field force size, structure and territory boundaries. Furthermore, the recent NDA filing has triggered additional investments in systems, training programs, supply chain and logistics as we continue to plan for a potential launch.
Continued to expand our therapeutic Medical Scientists team and began development of our Managed Healthcare Medical Science Liaison team. We completed vendor selection for the Medical Contact Center and finalized design of our Investigator Sponsored Study Program.
Announced topline results of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a Phase 3 clinical trial of omecamtiv mecarbil in patients with HFrEF. METEORIC-HF evaluated the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET). There was no effect on the primary endpoint of change in peak oxygen uptake (pVO2) on CPET from baseline to Week 20 in patients treated with omecamtiv mecarbil compared to placebo. Adverse events, including major cardiac events, were similar between the treatment arms, and the safety profile of omecamtiv mecarbil was consistent with prior clinical trials, including GALACTIC-HF. The results from METEORIC-HF will be presented at the American College of Cardiology 71st Annual Scientific Session & Expo in Washington, D.C., as part of a Late Breaking Clinical Trial session on Sunday, April 3, 2022.
Presented results from additional analyses from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) at the American Heart Association (AHA) Scientific Sessions 2021 showing that treatment with omecamtiv mecarbil was associated with a significant reduction in the risk of stroke.
aficamten (cardiac myosin inhibitor)
Opened enrollment in SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM). SEQUOIA-HCM is a Phase 3 randomized, placebo-controlled, double-blind, multi-center clinical trial designed to evaluate aficamten in patients with symptomatic obstructive HCM on background medical therapy for 24 weeks. The primary endpoint is the change in pVO2 measured by CPET from baseline to week 24. SEQUOIA-HCM is expected to enroll 270 patients, randomized on a 1:1 basis to receive aficamten or placebo in addition to standard-of-care treatment. Each patient will receive up to four escalating doses of aficamten or placebo based on echocardiographic guidance alone.
Announced positive topline results from Cohort 3 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), which enrolled patients with symptomatic obstructive HCM and a resting or post-Valsalva left ventricular outflow tract gradient (LVOT-G) of ≥50 mmHg whose background therapy included disopyramide and in the majority a beta-adrenergic blocker. Results showed that substantial reductions in the average resting LVOT-G as well as the post-Valsalva LVOT-G (defined as resting gradient <30 mmHg and post-Valsalva gradient <50 mmHg) were achieved. In addition, the safety and tolerability of aficamten were consistent with prior experience in REDWOOD-HCM with no treatment interruptions and no serious adverse events attributed to treatment reported by the investigators. The results from Cohort 3 of REDWOOD-HCM will be presented at the American College of Cardiology 71st Annual Scientific Session & Expo in Washington, D.C., on Saturday, April 2, 2022.
Received Breakthrough Therapy Designation for aficamten for the treatment of symptomatic obstructive HCM from the (FDA).
The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for aficamten for the treatment of symptomatic obstructive HCM in China.
CK-3828136 (CK-136) (cardiac troponin activator)
Presented preclinical data relating to the discovery and optimization of CK-136 at the 2021 Medicinal Chemistry Gordon Research Conference in West Dover, VT, and presented preclinical data on a closely related analog to CK-136 related to its effect on cardiac contractility and energetics at the American Heart Association (AHA) Scientific Sessions 2021.
Skeletal Muscle Program
reldesemtiv (fast skeletal muscle troponin activator (FSTA))
Continued conduct of COURAGE-ALS (Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS), the Phase 3 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS).
Presented data from our ALS program at the 32nd International Symposium on ALS/MND, including an analysis of baseline characteristics from the initial 27 patients enrolled in COURAGE-ALS indicating that the majority of patients enrolled to date were categorized as middle or fast progressors. Supplemental analyses presented from FORTITUDE-ALS showed that declining grip strength was strongly correlated with declining fine motor function and declining arm function, and that extremity muscle strength was correlated with physical function and quality of life. Results were also presented from IMPACT ALS, a self-reported online survey of ALS patients and caregivers in Europe exploring perspectives on burden of disease and treatment.
Pre-Clinical Development and Ongoing Research
Continued to advance new muscle directed compounds and conduct IND-enabling studies with the expectation of our potentially moving 1-2 drug candidates into clinical development in the next year.
Continued research activities directed to our other muscle biology research programs.
Corporate
Secured long-term capital from entities affiliated with Royalty Pharma to support the potential commercialization of omecamtiv mecarbil and the further development of aficamten. Royalty Pharma will provide Cytokinetics long-term capital of up to $300 million to support the potential commercialization of omecamtiv mecarbil and the further development of aficamten, and other general corporate purposes. Royalty Pharma also purchased a royalty on aficamten of 4.5% on sales up to $1 billion and 3.5% on sales above $1 billion, subject to certain potential step-downs, in exchange for payments of up to $150 million.
Expanded collaboration with Ji Xing Pharmaceuticals Limited (Ji Xing), a biopharmaceutical company backed by investment funds affiliated with RTW Investments, LP (RTW), by entering into an exclusive license and collaboration agreement to develop and commercialize omecamtiv mecarbil for the proposed treatment of HFrEF in Greater China. The company also entered into Common Stock Purchase Agreements with investment funds affiliated with RTW. Cytokinetics has received committed capital of $70 million, and will receive up to $330 million from Ji Xing in additional milestone payments plus tiered royalties on the net sales of omecamtiv mecarbil in Greater China, subject to certain reductions.
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 reported 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.