CYTOKINETICS INC
For the period ended Mar 31, 2024. Filed May 10, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2024 · Filed May 10, 2024
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Glossary of Terms
Unless the context requires otherwise, references to “Cytokinetics,” “the Company,” “we,” “us” or “our” in this Quarterly Report on Form 10-Q refer to Cytokinetics, Incorporated and its subsidiaries. References to “Notes” in this Form 10-Q are to the Notes to the Condensed Consolidated Financial Statements in this Form 10-Q. We also have used other specific terms in this Form 10-Q, most of which are explained or defined below:
| Term/Abbreviation | Definition |
|---|---|
| 2004 Plan | Cytokinetics’ Amended and Restated 2004 Equity Incentive Plan |
| 2020 RTW Transactions | The transactions contemplated by the RTW Royalty Purchase Agreement, Ji Xing Aficamten License Agreement and the Common Stock Purchase Agreements, dated July 14, 2020, by and between Cytokinetics and the RTW Investors |
| 2021 RTW Transactions | The transactions contemplated by the Ji Xing OM License Agreement and the Common Stock Purchase Agreements, dated December 20, 2021 by and between Cytokinetics and the RTW Investors |
| 2022 RPI Transactions | The transactions contemplated by the RP Loan Agreement and the RP Aficamten RPA |
| 2026 Notes | Cytokinetics’ 4% convertible senior notes due 2026 |
| 2027 Indenture | Indenture Agreement, dated July 6, 2022, between Cytokinetics and U.S. Bank Trust Company, as trustee |
| 2027 Notes | Cytokinetics’ 3.50% convertible senior notes due 2027 |
| ACA | Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act |
| ACACIA-HCM | Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM |
| ACC | American College of Cardiology |
| AHA | American Heart Association |
| ALS | amyotrophic lateral sclerosis (also known as Lou Gehrig’s Disease) |
| ALSFRS-R | ALS Functional Rating Scale – Revised |
| Amended ATM Facility | amended and restated Controlled Equity Offering Sales Agreement |
| Amgen Agreement | Collaboration and Option Agreement, dated December 29, 2006, as amended, between Cytokinetics and Amgen |
| ARR | absolute risk reductions |
| Astellas Agreement | License and Collaboration Agreement, dated June 21, 2013, between Cytokinetics and Astellas |
| Astellas FSRA Agreement | Fast Skeletal Regulatory Activator Agreement, dated April 23, 2020 between Cytokinetics and Astellas |
| Astellas OSSA Agreement | License and Collaboration Agreement for Other Skeletal Sarcomere Activators, dated April 23, 2020, as amended, between Cytokinetics and Astellas |
| cGMP | current Good Manufacturing Practice |
| Cantor | Cantor Fitzgerald & Co. |
| China | People's Republic of China (including the Hong Kong and Macau SARs) |
| CMC | Chemistry, Manufacturing and Controls |
| CMO | Contract Manufacturing Organizations |
| Common Stock | our common stock, par value $0.001 per share |
| Compensation Committee | Compensation and Talent Committee of Cytokinetics’ Board of Directors |
| Convertible Notes | 2026 Notes and 2027 Notes |
| COURAGE-ALS | Clinical Outcomes Using Reldesemtiv on ALSFRS-R in a Global Evaluation in ALS |
| CPET | cardiopulmonary exercise testing |
| CRL | Complete Response Letter |
| CRO | Contract Research Organization |
|---|---|
| CV | cardiovascular |
| E.U. or EU | European Union |
| EEA | European Economic Area |
| EMA | European Medicines Agency |
| ESPP | employee stock purchase plan |
| Exchange Act | Securities Exchange Act of 1934, as amended |
| FDA | U.S. Food and Drug Administration |
| Final Payment Amount | As defined in Part I, Item 2 (Management’s Discussion and Analysis of Financial Conditions and Results of Operations) of this Quarterly Report on Form 10-Q – Sources and Uses of Cash, Royalty Pharma Transactions |
| FOREST-HCM | Five-Year, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM |
| FSRA | fast skeletal regulatory activator |
| FSTA | fast skeletal muscle troponin activator |
| Fundamental Change | As defined in the 2027 Indenture |
| GAAP | Generally Accepted Accounting Principles in the U.S. |
| GALACTIC-HF | Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure |
| GCP | Good Clinical Practice |
| GDPR | General Data Protection Regulation ((EU) 2016/679) |
| HCM | hypertrophic cardiomyopathy |
| HFpEF | heart failure with preserved ejection fraction |
| HFrEF | heart failure with reduced ejection fraction |
| HFSA | Heart Failure Society of America |
| HHS | U.S. Department of Health and Human Services |
| HIPAA | The federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act |
| ICER | Institute for Clinical and Economic Review |
| IND | Investigational New Drug |
| IRA | Inflation Reduction Act of 2022 |
| IRB | Institutional Review Board |
| Ji Xing | Ji Xing Pharmaceuticals Limited and/or its affiliates, including Ji Xing Pharmaceuticals Hong Kong Limited |
| Ji Xing Aficamten License Agreement | License and Collaboration Agreement, dated July 14, 2020, by and between Cytokinetics and Ji Xing Pharmaceuticals Limited |
| Ji Xing Agreements | Ji Xing Aficamten License Agreement and Ji Xing OM License Agreement |
| Ji Xing OM License Agreement | License and Collaboration Agreement, dated December 20, 2021, by and between Cytokinetics and Ji Xing Pharmaceuticals Limited |
| KCCQ | Kansas City Cardiomyopathy Questionnaire |
| KCCQ-OSS | KCCQ Overall Summary Score |
| Lenders | Silicon Valley Bank and Oxford Finance LLC |
| LVEF | left ventricular ejection fraction |
| LVOT | left ventricular outflow tract |
| LVOT-G | left ventricular outflow tract gradient |
| MAA | Marketing Authorization Application |
|---|---|
| MAPLE-HCM | Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Endpoints Capacity in HCM |
| Mavacamten Royalty | certain payments on the net sales of products containing the compound mavacamten pursuant to the Research Collaboration Agreement, dated August 24, 2012, between Cytokinetics and MyoKardia, Inc. |
| NDA | New Drug Application |
| nHCM | non-obstructive HCM |
| NOLs | net operating loss carryforward |
| NYHA | New York Heart Association |
| oHCM | obstructive HCM |
| OLE | Open-Label Extension |
| Ownership Change | As defined in Part II, Item 1A (Risk Factors) of this Quarterly Report on Form 10-Q, General Risks |
| Oxford | Oxford Finance LLC |
| Oyster Point Lease | Lease, dated July 24, 2019, by and between Cytokinetics and KR Oyster Point 1, LLC, as amended |
| Partial Redemption Limitation | As defined in the 2027 Indenture |
| PSU | Performance Stock Unit |
| Radnor Lease | As defined in Part I, Item 1 (Financial Statements (Unaudited)), Notes to Condensed Consolidated Financial Statements of this Quarterly Report on Form 10-Q - Note 9 (Commitments and Contingencies) – Operating Leases |
| REDWOOD-HCM | Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM |
| REDWOOD-HCM OLE | Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM Open Label Extension |
| REMS | Risk Evaluation and Mitigation Strategy |
| RP Aficamten RPA | Revenue Participation Right Purchase Agreement, dated January 7, 2022, by and between Cytokinetics and Royalty Pharma Investments 2019 ICAV |
| RP Loan Agreement | Development Funding Loan Agreement, dated January 7, 2022, by and among Royalty Pharma Development Funding, LLC and Cytokinetics |
| RP OM Liability | As defined in Part I, Item 1 (Financial Statements (Unaudited)), Notes to Condensed Consolidated Financial Statements of this Quarterly Report on Form 10-Q - Note 6 (Agreements with Royalty Pharma) – 2017 RP Omecamtiv Mecarbil Royalty Purchase Agreement |
| RP OM RPA | Royalty Purchase Agreement, dated February 1, 2017, by and between the Cytokinetics and RPI Finance Trust, as amended by Amendment No. 1, dated January 7, 2022 |
| RPDF | Royalty Pharma Development Funding, LLC |
| RPFT | RPI Finance Trust |
| RPI ICAV | Royalty Pharma Investments 2019 ICAV |
| RSU | Restricted Stock Unit |
| RTW ICAV | RTW Investments ICAV for RTW Fund 1 |
| RTW Investors | RTW Master Fund, Ltd., RTW Innovation Master Fund, Ltd. and RTW Venture Fund Limited |
| RTW Royalty Holdings | RTW Royalty Holdings Designated Activity Company |
| RTW Royalty Purchase Agreement | Royalty Purchase Agreement, dated July 14, 2020, between Cytokinetics and RTW Royalty Holdings |
| Section 382 | Section 382 of the Internal Revenue Code |
| Securities Act | Securities Act of 1933, as amended |
|---|---|
| SEQUOIA-HCM | Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM |
| SGLT2 | sodium-glucose cotransporter-2 |
| SMA | spinal muscular atrophy |
| SPA | Special Protocol Assessment |
| Tax Act | Tax Cuts and Jobs Act |
| Term Loan Agreement | Loan and Security Agreement, dated as of October 19, 2015, by and among Cytokinetics, Oxford Finance LLC and Silicon Valley Bank and Loan and Security Agreement, dated as of May 17, 2019, by and among Cytokinetics, Oxford Finance LLC and Silicon Valley Bank |
| U.S. or US | United States |
This Form 10-Q includes discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.
CYTOKINETICS and our C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Other service marks, trademarks and trade names referred to in this report are the property of their respective owners.
The information contained on our website, our Facebook, Instagram, YouTube and LinkedIn pages or our Twitter accounts, or any third-party website, is not incorporated by reference into this Form 10-Q.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.