UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 8, 2024, Cytokinetics, Incorporated announced its financial results for the second quarter ended June 30, 2024. The full text of the press release issued in connection with this announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information furnished under this Item 2.02 and under Exhibit 99.1 shall not be considered “filed” under the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into any future filing under the Securities Act of 1933, as amended, or under the Securities Exchange Act of 1934, as amended, unless the Registrant expressly sets forth in such future filing that such information is to be considered “filed” or incorporated by reference therein.
Item 9.01 Financial Statements and Exhibits.
(d)
99.1 Press Release dated August 8, 2024
104 The cover page of this report has been formatted in Inline XBRL
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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CYTOKINETICS, INCORPORATED |
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Date: |
August 8, 2024 |
By: |
/s/ John O. Faurescu |
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John O. Faurescu, Esq., Vice President, Associate General Counsel & Secretary |
CYTOKINETICS REPORTS SECOND QUARTER 2024 FINANCIAL RESULTS
Type B Meeting Held with FDA Related to Potential Risk Mitigation Strategies for Aficamten;
Company Has Initiated Rolling NDA Submission
FDA Cleared Protocol Amendment for FOREST-HCM Reducing Frequency of
Echocardiographic Monitoring Required During Maintenance Treatment
~$1.4 Billion in Cash, Cash Equivalents and Investments as of June 30, 2024
SOUTH SAN FRANCISCO, Calif., Aug. 8, 2024 - Cytokinetics, Incorporated (Nasdaq: CYTK) reported a management update and financial results for the second quarter of 2024.
“Cytokinetics made substantial progress during the second quarter across our pipeline and aligned to near-term goals as well as our longer-term vision to build a sustainable specialty cardiology business. In May, we secured contingent access to more than $1 billion in funding to support the potential global launch of aficamten as well as to continue conduct of label-expanding clinical trials of aficamten worldwide and to advance our later-stage pipeline including omecamtiv mecarbil and CK-586,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “These three programs, anchored in our pioneering science of myosin modulation provide synergistic opportunities in adjacent specialty cardiology indications that we believe will unlock shareholder value while making good on our promise to patients.”
Q2 and Recent Highlights
Cardiac Muscle Programs
aficamten (cardiac myosin inhibitor)
omecamtiv mecarbil (cardiac myosin activator)
CK-4021586 (CK-586, cardiac myosin inhibitor)
CK-3828136 (CK-136, cardiac troponin activator)
Pre-Clinical Development and Ongoing Research
Corporate
Second Quarter 2024 Financial Results
Cash, Cash Equivalents and Investments
As of June 30, 2024, the company had approximately $1.4 billion in cash, cash equivalents and investments compared to $634.3 million at March 31, 2024. In the second quarter, the company completed a public offering of 11,274,510 shares of its common stock which included the underwriters’ exercise in full of their option to purchase additional shares, raising approximately $563.2 million in net proceeds, after deducting underwriting discounts and commissions. On May 22, 2024, the company entered into a strategic funding collaboration with Royalty Pharma totaling up to $575 million to support the commercialization of aficamten and to advance the company’s expanding cardiovascular pipeline as the company advances its muscle biology-directed specialty cardiology business. The company received $250 million upon execution, including $100 million to fund a confirmatory Phase 3 trial of omecamtiv mecarbil, $50 million to fund a proof-of-concept Phase 2a clinical trial for CK-586, $50 million term loan to support the potential commercial launch of aficamten in obstructive HCM, and $50 million from the purchase of Cytokinetics’ common stock in a private placement. Under the terms of the collaboration, the company, at its option, can borrow up to $175 million upon satisfaction of certain conditions and receive up to $150 million investment in a Phase 3 clinical trial of CK-586 subject to Royalty Pharma exercising its option to participate in the funding of such a trial in exchange for an additional revenue interest in the net sales of CK-586.
Revenues
Research and Development (R&D) Expenses
General and Administrative (G&A) Expenses
Net Income (Loss)
2024 Financial Guidance
The company is updating its full year 2024 financial guidance:
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Current Guidance |
Previous Guidance |
GAAP Operating Expense[1] |
$555m to $575m |
$535m to $555m |
Non-cash Expense[2] Included in GAAP Operating Expense |
$110m to $105m |
$115m to $105m |
Non-GAAP Operating Expense[3] |
$445m to $470m |
$420m to $450m |
Net Cash Utilization[4] |
$400m to $420m |
$390m to $420m |
The financial guidance does not include the effect of GAAP adjustments caused by events that may occur subsequent to the publication of this guidance including but not limited to business development activities.
[1]GAAP operating expense comprised of R&D and G&A expenses.
[2]Non-cash operating expense comprised of stock-based compensation and depreciation.
[3]Non-GAAP operating expense comprised of R&D and G&A expenses but excludes non-cash operating expense.
[4]Net cash utilization is a non-GAAP financial measure that we define as our ending 2023 cash, cash equivalents, and investments balance of $655 million plus the net proceeds of $707 million received from the sale of common stock (through the at-the-market facility, public offerings, and stock purchase agreement with Royalty Pharma) plus proceeds of $200 million received from the structured financing
agreement with Royalty Pharma announced on May 22, 2024 minus our projected ending 2024 cash, cash equivalents, and investments balance of between $1,142 million and $1,162 million.
Conference Call and Webcast Information
Members of Cytokinetics’ senior management team will review the company’s second quarter 2024 results on a conference call today at 4:30 PM Eastern Time. The conference call will be simultaneously webcast and can be accessed from 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 registering in advance at the following link: Cytokinetics Q2 2024 Earnings Conference Call. Upon registration, participants will receive a dial-in number and a unique passcode to access the call. An archived replay of the webcast will be available via Cytokinetics’ website for twelve months.
About Cytokinetics
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing muscle biology directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Cytokinetics is preparing for regulatory submissions for aficamten, its next-in-class cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in obstructive hypertrophic cardiomyopathy which were published in the New England Journal of Medicine. Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle activator, in patients with heart failure. Additionally, Cytokinetics is developing CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten for the potential treatment of HFpEF
For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but not limited to, statements, express or implied, relating to our or our partners’ research and development and commercial readiness activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of any of our clinical trials, or more specifically, our ability to file a new drug application for aficamten in the United States in the third quarter of 2024 or a marketing authorisation application for
aficamten in the European Union in the fourth quarter of 2024, our ability to complete enrollment of MAPLE-HCM in the third quarter of 2024, our ability to complete enrollment of ACACIA-HCM in 2025, our ability to start a new Phase 3 confirmatory trial of omecamtiv mecarbil in the fourth quarter of 2024, and to commence a Phase 2a study of CK-586, if ever, the timing of interactions with FDA or any other regulatory authorities in connection to any of our drug candidates and the outcomes of such interactions; statements relating to the potential patient population who could benefit from aficamten, omecamtiv mecarbil, CK-586, CK-136 or any of our other drug candidates; statements relating to our ability to receive additional capital or other funding, including, but not limited to, our ability to meet any of the conditions relating to or to otherwise secure additional loan disbursements under any of our agreements with entities affiliated with Royalty Pharma or additional milestone payments from Ji Xing; statements relating to our operating expenses or cash utilization for the remainder of 2024, and statements relating to our cash balance at year-end 2024 or any other particular date or the amount of cash runway such cash balances represent at any particular time. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to Cytokinetics’ need for additional funding and such additional funding may not be available on acceptable terms, if at all; potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; patient enrollment for or conduct of clinical trials may be difficult or delayed; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Cytokinetics may incur unanticipated research and development and other costs; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission, particularly under the caption “Risk Factors” in Cytokinetics’ Annual Report on Form 10-K for the year 2023. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries.
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Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757
Cytokinetics, Incorporated |
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Condensed Consolidated Balance Sheets |
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(in thousands) |
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June 30, 2024 |
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December 31, 2023 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and short term investments |
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$ 1,056,775 |
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$ 614,824 |
Other current assets |
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11,035 |
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13,227 |
Total current assets |
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1,067,810 |
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628,051 |
Long-term investments |
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305,361 |
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40,534 |
Property and equipment, net |
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65,689 |
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68,748 |
Operating lease right-of-use assets |
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77,249 |
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78,987 |
Other assets |
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7,679 |
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7,996 |
Total assets |
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$ 1,523,788 |
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$ 824,316 |
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ 49,283 |
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$ 64,148 |
Short-term operating lease liabilities |
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18,507 |
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17,891 |
Current portion of long-term debt |
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11,520 |
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10,080 |
Derivative liabilities measured at fair value |
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13,200 |
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— |
Other current liabilities |
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10,267 |
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10,559 |
Total current liabilities |
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102,777 |
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102,678 |
Term loan, net |
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92,831 |
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58,384 |
Convertible notes, net |
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550,600 |
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548,989 |
Liabilities related to revenue participation right purchase agreements, net |
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435,112 |
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379,975 |
Long-term operating lease liabilities |
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116,718 |
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120,427 |
Liabilities related to RPI Transactions measured at fair value |
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117,200 |
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— |
Other non-current liabilities |
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— |
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186 |
Total liabilities |
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1,415,238 |
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1,210,639 |
Commitments and contingencies |
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Stockholders’ equity (deficit): |
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Common stock |
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117 |
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102 |
Additional paid-in capital |
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2,500,654 |
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1,725,823 |
Accumulated other comprehensive loss |
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(1,022) |
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(10) |
Accumulated deficit |
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(2,391,199) |
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(2,112,238) |
Total stockholders’ equity (deficit) |
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108,550 |
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(386,323) |
Total liabilities and stockholders’ equity (deficit) |
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$ 1,523,788 |
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$ 824,316 |
Cytokinetics, Incorporated |
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Condensed Consolidated Statements of Operations |
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(in thousands except per share data) |
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(unaudited) |
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Three Months Ended |
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June 30, 2024 |
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June 30, 2023 |
Revenues: |
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Research and development revenues |
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$ 249 |
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$ 867 |
Milestone revenues |
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— |
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— |
Total revenues |
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249 |
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867 |
Operating expenses: |
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Research and development |
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79,597 |
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83,194 |
General and administrative |
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50,824 |
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39,722 |
Total operating expenses |
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130,421 |
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122,916 |
Operating loss |
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(130,172) |
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(122,049) |
Interest expense |
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(12,732) |
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(7,045) |
Non-cash interest expense on liabilities related to revenue participation right purchase agreements |
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(11,567) |
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(6,322) |
Interest and other income, net |
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11,553 |
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6,779 |
Change in fair value of derivative liabilities |
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(600) |
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— |
Change in fair value of liabilities related to RPI Transactions |
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200 |
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— |
Net loss |
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$ (143,318) |
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$ (128,637) |
Net loss per share — basic and diluted |
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$ (1.31) |
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$ (1.34) |
Weighted-average number of shares used in computing net loss per share — basic and diluted |
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109,240 |
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95,755 |