UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
For the quarterly period ended
or
For the transition period from to
Commission file number:
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
|
|
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
|
Trading symbol
|
Name of each exchange on which registered
|
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 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
|
Accelerated filer ☐ |
|
Non-accelerated filer ☐ |
|
Smaller reporting company |
|
Emerging growth company |
|
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
Number of shares of common stock, $0.001 par value, outstanding as of November 1, 2023:
CYTOKINETICS, INCORPORATED
TABLE OF CONTENTS FOR FORM 10-Q
FOR THE three and nine months ended September 30, 2023
2
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 |
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 |
ASU 2020-06 |
|
ASU 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity |
BTR/W |
|
background therapy reduction/withdrawal |
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 |
3
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 |
DMC |
|
Data Monitoring Committee |
E.U. or EU |
|
European Union |
EEA |
|
European Economic Area |
eGFR |
|
estimated glomerular filtration rate |
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, 2022 Royalty Pharma Transactions |
FOREST-HCM |
|
Five-Year, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM |
FORTITUDE-ALS |
|
Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS |
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 |
4
KCCQ |
|
Kansas City Cardiomyopathy Questionnaire |
KCCQ-OSS |
|
KCCQ Overall Summary Score |
Lenders |
|
Silicon Valley Bank and Oxford Finance LLC |
LSM |
|
least square mean |
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 Liability |
|
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 – Results of Operations, Non-cash interest expense on liabilities related to revenue participation right purchase agreements |
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 |
5
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 |
SAM |
|
systolic anterior motion |
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 |
SVC |
|
slow vital capacity |
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.
6
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CYTOKINETICS, INCORPORATED
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data) (Unaudited)
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
||
ASSETS |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Short-term investments |
|
|
|
|
|
|
||
Accounts receivable |
|
|
|
|
|
|
||
Prepaid expenses and other current assets |
|
|
|
|
|
|
||
Total current assets |
|
|
|
|
|
|
||
Long-term investments |
|
|
|
|
|
|
||
Property and equipment, net |
|
|
|
|
|
|
||
Operating lease right-of-use assets |
|
|
|
|
|
|
||
Other assets |
|
|
|
|
|
|
||
Total assets |
|
$ |
|
|
$ |
|
||
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
|
|
$ |
|
||
Accrued liabilities |
|
|
|
|
|
|
||
Short-term operating lease liabilities |
|
|
|
|
|
|
||
Other current liabilities |
|
|
|
|
|
|
||
Total current liabilities |
|
|
|
|
|
|
||
Term loan, net |
|
|
|
|
|
|
||
Convertible notes, net |
|
|
|
|
|
|
||
Liabilities related to revenue participation right purchase agreements, net |
|
|
|
|
|
|
||
Long-term operating lease liabilities |
|
|
|
|
|
|
||
Other non-current liabilities |
|
|
|
|
|
|
||
Total liabilities |
|
|
|
|
|
|
||
|
|
|
|
|
|
|||
Stockholders’ deficit: |
|
|
|
|
|
|
||
Preferred stock, $ |
|
|
|
|
|
|
||
Common stock, $ |
|
|
|
|
|
|
||
Additional paid-in capital |
|
|
|
|
|
|
||
Accumulated other comprehensive loss |
|
|
( |
) |
|
|
( |
) |
Accumulated deficit |
|
|
( |
) |
|
|
( |
) |
Total stockholders’ deficit |
|
|
( |
) |
|
|
( |
) |
Total liabilities and stockholders’ deficit |
|
$ |
|
|
$ |
|
||
The accompanying notes are an integral part of these condensed consolidated financial statements.
7
CYTOKINETICS, INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except per share data) (Unaudited)
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
||||||||||
|
|
September 30, 2023 |
|
|
September 30, 2022 |
|
|
September 30, 2023 |
|
|
September 30, 2022 |
|
||||
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development revenues |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Milestone revenues |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Realization of revenue participation right purchase agreement |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total revenues |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
|
|
|
|
|
|
|
|
|
|
||||
General and administrative |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating loss |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Interest expense |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Loss on extinguishment of debt |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Non-cash interest expense on liabilities related to revenue participation right purchase agreements |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Interest and other income, net |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Net loss per share — basic and diluted |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
Weighted-average number of shares used in computing net loss per share — basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized gain (loss) on available-for-sale securities, net |
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
||
Comprehensive loss |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
The accompanying notes are an integral part of these condensed consolidated financial statements.
8
CYTOKINETICS, INCORPORATED
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ (Deficit) Equity
(In thousands, except share data) (Unaudited)
|
|
Common Stock |
|
|
Additional |
|
|
Accumulated |
|
|
Accumulated |
|
|
Total |
|
|||||||||
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
(Loss) Income |
|
|
Deficit |
|
|
Deficit |
|
||||||
Balance, December 31, 2022 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|||
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Vesting of restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Shares withheld related to net share settlement of equity awards |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
( |
) |
|||
Stock-based compensation |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Other comprehensive income |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Net loss |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|||
Balance, March 31, 2023 |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|||
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Vesting of restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Issuance of common stock under |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Stock-based compensation |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Other comprehensive income |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Net loss |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|||
Balance, June 30, 2023 |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|||
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Vesting of restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Issuance of common stock under at-the-market offering, net of issuance costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Stock-based compensation |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Other comprehensive income |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Net loss |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|||
Balance, September 30, 2023 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
( |
) |
|||
9
|
|
Common Stock |
|
|
Additional |
|
|
Accumulated |
|
|
Accumulated |
|
|
Total |
|
|||||||||
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Loss |
|
|
Deficit |
|
|
Equity (Deficit) |
|
||||||
Balance, December 31, 2021 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
( |
) |
|
$ |
|
||||
ASU 2020-06 adoption |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
( |
) |
||||
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Vesting of restricted stock units |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Shares withheld related to net share settlement of equity awards |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
( |
) |
|||
Stock-based compensation |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Other comprehensive loss |
|
|
— |
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
( |
) |
|||
Net loss |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|||
Balance, March 31, 2022 |
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|||||