Cytokinetics Reports Fourth Quarter 2021 Financial Results
Commercial Launch Readiness Activities Underway for Omecamtiv Mecarbil in Advance of PDUFA Date of
SEQUOIA-HCM Open to Enrollment;
Company Provides 2022 Financial Guidance;
More Than 2 Years of Cash Runway
“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
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 ofNovember 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 AnnualScientific Session & Expo inWashington, D.C. , as part of a Late Breaking Clinical Trial session onSunday, 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 AnnualScientific Session & Expo inWashington, D.C. , onSaturday, 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 theNational Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for aficamten for the treatment of symptomatic obstructive HCM inChina .
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 inWest Dover, VT , and presented preclinical data on a closely related analog to CK-136 related to its effect on cardiac contractility and energetics at theAmerican 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.
- 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 withRTW Investments, LP (RTW), by entering into an exclusive license and collaboration agreement to develop and commercialize omecamtiv mecarbil for the proposed treatment of HFrEF inGreater 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 inGreater 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
Research and development expenses for the three and twelve months ended
General and administrative expenses for the three and twelve months ended
2022 Financial Guidance
The company today announced financial guidance for 2022. The company anticipates revenue will be in the range of
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) (
An archived replay of the webcast will be available via Cytokinetics’ website until
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Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”).
CYTOKINETICS® and the
Contact:
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(425) 314-1721
Condensed Consolidated Balance Sheets | |||||||||
(in thousands) | |||||||||
(unaudited) | |||||||||
ASSETS | |||||||||
Current assets: | |||||||||
Cash and short term investments | $ | 471,638 | $ | 464,060 | |||||
Other current assets | 64,034 | 10,161 | |||||||
Total current assets | 535,672 | 474,221 | |||||||
Long-term investments | 152,050 | 36,954 | |||||||
Property and equipment, net | 73,271 | 13,346 | |||||||
Operating lease right-of-use assets | 73,138 | 2,924 | |||||||
Other assets | 7,188 | 6,358 | |||||||
Total assets | $ | 841,319 | $ | 533,803 | |||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||
Current liabilities: | |||||||||
Accounts payable and accrued liabilities | $ | 55,457 | $ | 27,365 | |||||
Short-term lease liability | 14,863 | 2,785 | |||||||
Other current liabilities | 1,540 | 1,049 | |||||||
Total current liabilities | 71,860 | 31,199 | |||||||
Term loan, net | 47,367 | 46,209 | |||||||
Convertible notes, net | 95,471 | 89,504 | |||||||
Liabilities related to revenue participation right purchase agreement, net | 179,072 | 166,068 | |||||||
Long-term deferred revenue | 87,000 | 87,000 | |||||||
Long-term operating lease liabilities | 112,229 | 440 | |||||||
Other non-current liabilities | 4,457 | — | |||||||
Total liabilities | 597,456 | 420,420 | |||||||
Commitments and contingencies | |||||||||
Stockholders’ equity: | |||||||||
Common stock | 84 | 70 | |||||||
Additional paid-in capital | 1,452,268 | 1,105,470 | |||||||
Accumulated other comprehensive income | (869 | ) | 149 | ||||||
Accumulated deficit | (1,207,620 | ) | (992,306 | ) | |||||
Total stockholders’ equity | 243,863 | 113,383 | |||||||
Total liabilities and stockholders’ equity | $ | 841,319 | $ | 533,803 |
Condensed Consolidated Statements of Operations | |||||||||||||||
(in thousands except per share data) | |||||||||||||||
(unaudited) | |||||||||||||||
Three Months Ended |
Years Ended |
||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenues: | |||||||||||||||
Research and development revenues | $ | 744 | $ | 4,222 | $ | 10,572 | $ | 16,527 | |||||||
License revenues | 54,856 | — | 54,856 | 36,501 | |||||||||||
Milestone revenues | — | 2,500 | 5,000 | 2,800 | |||||||||||
Total revenues | 55,600 | 6,722 | 70,428 | 55,828 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 43,498 | 29,221 | 159,938 | 96,951 | |||||||||||
General and administrative | 33,806 | 13,908 | 96,803 | 52,820 | |||||||||||
Total operating expenses | 77,304 | 43,129 | 256,741 | 149,771 | |||||||||||
Operating loss | (21,704 | ) | (36,407 | ) | (186,313 | ) | (93,943 | ) | |||||||
Interest expense | (4,218 | ) | (4,018 | ) | (16,440 | ) | (15,963 | ) | |||||||
Non-cash interest expense on liability related to sale of future royalties | (4,271 | ) | (5,651 | ) | (12,892 | ) | (22,713 | ) | |||||||
Interest and other income, net | (377 | ) | 2,146 | 331 | 5,329 | ||||||||||
Net loss before income taxes | (30,570 | ) | (43,930 | ) | (215,314 | ) | (127,290 | ) | |||||||
Income tax benefit | — | — | — | — | |||||||||||
Net loss | $ | (30,570 | ) | $ | (43,930 | ) | $ | (215,314 | ) | $ | (127,290 | ) | |||
Net loss per share — basic and diluted | $ | (0.36 | ) | $ | (0.62 | ) | $ | (2.80 | ) | $ | (1.97 | ) | |||
Weighted-average shares in net loss per share — basic and diluted | 84,087 | 70,833 | 76,886 | 64,524 |
Source: Cytokinetics, Incorporated