Cytokinetics(CYTK)
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Cytokinetics(CYTK) - 2022 Q1 - Quarterly Report
2022-05-05 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 000-50633 Delaware 94-3291317 (State or other jurisdiction of incorporation or organization)(I.R.S. Employer Iden ...
Cytokinetics(CYTK) - 2022 Q1 - Earnings Call Transcript
2022-05-05 02:15
Cytokinetics, Incorporated (NASDAQ:CYTK) Q1 2022 Earnings Conference Call May 4, 2022 4:30 PM ET Company Participants Diane Weiser - SVP of Corporate Communications and IR Robert Blum - President and CEO Fady Malik - EVP of R&D Andrew Callos - EVP and Chief Commercial Officer Stuart Kupfer - SVP and Chief Medical Officer Robert Wong - VP and CAO Ching Jaw - SVP and CFO Conference Call Participants Carter Gould - Barclays Joe Pantginis - H.C. Wainwright Salim Syed - Mizuho Securities Sean McCutcheon - R ...
Cytokinetics (CYTK) Investor Presentation - Slideshow
2022-03-16 17:21
Sarcomere Directed Therapies | --- | --- | --- | --- | --- | --- | |-------------------|-------|-------|-------|-------|-------| | | | | | | | | EMPOWERING | | | | | | | MUSCLE EMPOWERING | | | | | | | LIVES | | | | | | Nefertari, diagnosed with heart failure Jillian, diagnosed with HCM Chuck, diagnosed with ALS Actual patients who consented to use of their name, image, and condition. CYTOKINETICS® and the C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries Copyri ...
Cytokinetics(CYTK) - 2021 Q4 - Earnings Call Transcript
2022-02-25 14:35
Financial Data and Key Metrics Changes - The company ended Q4 2021 with $623.7 million in cash and investments, excluding $150 million from recent transactions [36] - Revenue for Q4 2021 was primarily $54.9 million from license revenue, with R&D expenses increasing to $43.5 million from $29.2 million in Q4 2020 [36][38] - G&A expenses rose to $33.8 million from $13.9 million in Q4 2020, mainly due to higher outside service spending and personnel-related costs [36][38] Business Line Data and Key Metrics Changes - The NDA for omecamtiv mecarbil was accepted by the FDA with a PDUFA date of November 30, 2022, marking a significant milestone for the company [5][15] - The METEORIC-HF trial did not show an effect on exercise capacity compared to placebo, which was disappointing, but the NDA is based on GALACTIC-HF results [6][11] - Aficamten received breakthrough therapy designation from the FDA, and the SEQUOIA-HCM Phase III trial has opened for enrollment [7][20] Market Data and Key Metrics Changes - The company is actively pursuing opportunities to partner omecamtiv mecarbil in Europe and Japan while planning to launch it in the US [46] - The company anticipates 2022 revenue in the range of $20 million to $25 million, with operating expenses between $380 million to $400 million [38] Company Strategy and Development Direction - The company aims to expand its development programs for aficamten and CK-136 while progressing with reldesemtiv and earlier-stage candidates [45][48] - The strategy includes building commercial capabilities for omecamtiv mecarbil and engaging with global health technology assessment organizations for aficamten [31][34] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential approval of omecamtiv mecarbil and the expansion of development programs for aficamten [45][47] - The company expects a slow ramp-up in commercial spending in 2022, with significant increases anticipated in 2023 following potential drug approvals [39][76] Other Important Information - The company has secured long-term capital commitments, including up to $300 million from Royalty Pharma to support commercialization efforts [41][42] - The company plans to pursue additional business development and financing opportunities in 2022 [44] Q&A Session Summary Question: Decision to launch the second Phase III study for aficamten - Management clarified that the decision was not in response to FDA requests but reflects confidence in aficamten's potential [50][51] Question: Observations on peak VO2 reliability as an endpoint during COVID-19 - The quality of data from the METEORIC trial was surprisingly good, with few missing tests, indicating that the pandemic did not significantly affect the outcomes [53][54] Question: Clinical activity measures for the fourth cohort of aficamten - Management indicated that the cohort will include symptomatic patients, and they will track circulating biomarkers to assess disease severity [55][56] Question: Futility analysis criteria for COURAGE-ALS - The futility analysis will assess whether reldesemtiv shows a trend of greater benefit versus placebo after 1/3 of patients have reached 12 weeks of treatment [81] Question: Study design elements for COURAGE-ALS - The study design has been enriched based on learnings from FORTITUDE-ALS, focusing on dose selection and patient population to increase the chances of success [87][88]
Cytokinetics(CYTK) - 2021 Q4 - Annual Report
2022-02-24 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 From the transition period from to Commission file number: 000-50633 | --- | --- | |-------------------------------------------------------------------------------------------------------------- ...
Cytokinetics(CYTK) - 2021 Q3 - Quarterly Report
2021-11-04 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Common Stock, $0.001 par value Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 ...
Cytokinetics(CYTK) - 2021 Q3 - Earnings Call Transcript
2021-11-04 05:03
Cytokinetics, Incorporated (NASDAQ:CYTK) Q3 2021 Earnings Conference Call November 3, 2021 4:30 PM ET Company Participants Joanna Siegall - Senior Manager of Corporate Communications and IR Robert Blum - President and CEO Fady Malik - EVP of R&D Stuart Kupfer - SVP and Chief Medical Officer Robert Wong - VP and CAO Ching Jaw - SVP and CFO Andrew Callos - CCO Conference Call Participants Dane Leone - Raymond James Joe Pantginis - H.C. Wainwright Yasmeen Rahimi - Piper Sandler Jeff Hung - Morgan Stanley Akash ...
Cytokinetics, Incorporated (CYTK) releases Corporate Presentation
2021-08-09 15:52
Sarcomere Directed Therapies | --- | --- | --- | --- | |-------------------|-------|-------|-------| | | | | | | | | | | | EMPOWERING | | | | | MUSCLE EMPOWERING | | | | | LIVES | | | | John, diagnosed with heart failure Jillian, diagnosed with HCM Chuck, diagnosed with ALS Forward-Looking Statements This Presentation contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-lo ...
Cytokinetics(CYTK) - 2021 Q2 - Earnings Call Transcript
2021-08-06 03:03
Cytokinetics, Incorporated (NASDAQ:CYTK) Q2 2021 Earnings Conference Call August 5, 2021 4:30 PM ET Company Participants Diane Weiser - Senior Vice President of Corporate Communications and Investor Relations Robert Blum - President and Chief Executive Officer Fady Malik - Executive Vice President of R&D Stuart Kupfer - Senior Vice President and Chief Medical Officer Robert Wong - Vice President and Chief Accounting Officer Ching Jaw - Senior Vice President and Chief Financial Officer Andrew Callos - Chief ...
Cytokinetics(CYTK) - 2021 Q2 - Quarterly Report
2021-08-05 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Common Stock, $0.001 par value Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 duri ...