Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial
results for the fourth quarter and full year 2023. Net loss for the
fourth quarter was $136.9 million or $1.38 per share and the net
loss for the year 2023 was $526.2 million or $5.45 per share. Net
loss for the fourth quarter of 2022 was $137.4 million or $1.45 per
share and net loss for the year 2022 was $389.0 million or $4.33
per share. Cash, cash equivalents and investments totaled $655.4
million on December 31, 2023. This cash balance does not include
approximately $83 million in net proceeds generated in early 2024
from the sale of common stock through an at-the-market equity
vehicle.
“We ended 2023 strong with positive results from
SEQUOIA-HCM which now propel our company forward to the next stages
of planning towards our specialty cardiology business model,” said
Robert I. Blum, Cytokinetics’ President and Chief Executive
Officer. “As we prepare regulatory submissions for aficamten, we
are executing on commercial readiness activities while also
conducting Phase 3 clinical trials in patients with oHCM and nHCM
which we believe may further generate evidence in support of our
next-in-class objectives to reach a broader array of patients
struggling with hypertrophic cardiomyopathy. With a strong balance
sheet enabling ample cash runway and multiple levers to access
capital, we are pleased to be turning the page onto the next
chapter for Cytokinetics and all stakeholders.”
Q4 and Recent Highlights
Cardiac Muscle Programs
aficamten (cardiac myosin
inhibitor)
- Announced positive results from
SEQUOIA-HCM (Safety, Efficacy,
and Quantitative Understanding of
Obstruction Impact of
Aficamten in HCM) in December
demonstrating that treatment with aficamten significantly improved
exercise capacity compared to placebo, increasing peak oxygen
uptake (pVO2) measured by cardiopulmonary exercise testing (CPET)
by a least square mean difference (95% CI) of 1.74 (1.04 - 2.44)
mL/kg/min (p=0.000002). Statistically significant (p<0.0001) and
clinically meaningful improvements were also observed in all 10
prespecified secondary endpoints. Aficamten was well-tolerated with
an adverse event profile comparable to placebo. There were no
instances of worsening heart failure or treatment interruptions due
to low left ventricular ejection fraction (LVEF).
- Presented new long-term data from
FOREST-HCM (Follow-up,
Open-Label, Research
Evaluation of Sustained
Treatment with Aficamten in HCM)
in January at CMR 2024 demonstrating that treatment with aficamten
for 48 weeks resulted in favorable structural remodeling,
improvements in cardiac function and stabilization of myocardial
fibrosis.
- Convened meetings in February with
the U.S. Food & Drug Administration (FDA) to discuss the
topline results of SEQUOIA-HCM and prepare for the New Drug
Application (NDA) submission.
- Engaged in commercial readiness
activities for aficamten including market research with
hypertrophic cardiomyopathy (HCM) patients and customer account
profiling, and held initial conversations with specialty pharmacies
and patient hub providers.
- Advanced profiling of HCM treatment
programs, began development of payor clinical value proposition and
continued support of medical education activities at medical
conferences.
- Continued enrolling patients in
MAPLE-HCM (Metoprolol vs
Aficamten in Patients with
LVOT Obstruction on Exercise
Capacity in HCM), the Phase 3 clinical trial
comparing aficamten as monotherapy to metoprolol as monotherapy in
patients with symptomatic obstructive HCM.
- Continued enrolling patients in
ACACIA-HCM (Assessment Comparing
Aficamten to Placebo on Cardiac
Endpoints In Adults with
Non-Obstructive HCM), the pivotal Phase 3 clinical
trial of aficamten in patients with non-obstructive HCM.
- Published manuscript entitled
“Exercise Capacity in Patients with Obstructive Hypertrophic
Cardiomyopathy: SEQUOIA-HCM Baseline Characteristics and Study
Design” in the Journal of the American College of Cardiology: Heart
Failure.
omecamtiv mecarbil (cardiac
myosin activator)
- Received the Day 180 List of
Outstanding Issues from the European Medicines Agency (EMA)
regarding the Marketing Authorization Application (MAA) for
omecamtiv mecarbil during Q4 2023, and submitted responses during
Q1 2024.
- Received denial of our Formal
Dispute Resolution Request (FDRR) to the Office of New Drugs of the
FDA in connection to the Complete Response Letter (CRL) received in
response to our NDA for omecamtiv mecarbil. FDA reaffirmed its
decision in the CRL for omecamtiv mecarbil that GALACTIC-HF is not
sufficiently persuasive to establish substantial evidence of
effectiveness for reducing the risk of heart failure events and
cardiovascular death in adults with chronic heart failure with
reduced ejection fraction (HFrEF), in lieu of evidence from at
least two adequate and well-controlled clinical
investigations.
- Published manuscript entitled “Sex
Differences in Heart Failure with Reduced Ejection Fraction in the
GALACTIC-HF Trial” in the Journal of the American College of
Cardiology: Heart Failure.
CK-4021586 (CK-586, cardiac myosin
inhibitor)
- Proceeded to multiple ascending
dose (MAD) cohorts of the Phase 1 study of CK-586 in healthy
participants.
CK-3828136 (CK-136, cardiac
troponin activator)
- Proceeded to MAD cohorts of the
Phase 1 study of CK-136 in healthy participants.
Skeletal Muscle Program
reldesemtiv (fast skeletal
muscle troponin activator (FSTA))
- Presented results from COURAGE-ALS
(Clinical Outcomes
Using Reldesemtiv on
ALSFRS-R in a Global
Evaluation in ALS) at the 34th
International Symposium on ALS/MND showing that treatment with
reldesemtiv for 24 weeks had no effect on the primary efficacy
endpoint measure of change from baseline up to Week 24 in the ALS
Functional Rating Scale Revised (ALSFRS-R) (joint rank test
p=0.11).
Pre-Clinical Development and Ongoing
Research
- Continued research activities
directed to our other muscle biology research programs.
Corporate
- Raised $162.9 million, net, from
the sale of common stock through an at-the-market (ATM) equity
vehicle in Q4 2023, and approximately $83 million, net, in Q1 2024
as of February 26, 2024.
2024 Corporate Milestones
Cardiac Muscle Programs
aficamten (cardiac myosin
inhibitor)
- Expect to present primary results
from SEQUOIA-HCM at a medical conference in Q2 2024.
- Expect to submit a New Drug
Application (NDA) to the FDA in Q3 2024 and a Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMA) in Q4 2024.
- Complete enrollment of MAPLE-HCM in
Q3 2024.
- Continue enrollment of ACACIA-HCM
in 2024.
- Continue advancing go-to-market
strategies for aficamten.
omecamtiv mecarbil (cardiac
myosin activator)
- Expect the Committee for Medicinal
Products for Human Use (CHMP) to issue an opinion regarding the MAA
for omecamtiv mecarbil in Q2 2024.
CK-4021586 (CK-586, cardiac
myosin inhibitor)
- Expect to share data from the Phase
1 study of CK-586 in Q2 2024.
CK-3828136 (CK-136, cardiac
troponin activator)
- Expect to complete Phase 1 study of
CK-136 in Q2 2024.
Financials
Revenues for the three months and year ended
December 31, 2023 were $1.7 million and $7.5 million, respectively,
compared to $2.0 million and $94.6 million in the corresponding
periods of 2022. The decrease in revenues was primarily due to the
recognition in 2022 of $87.0 million of deferred revenue for
royalties on the net sales of products containing mavacamten as a
result of the extinguishment of royalty obligations.
Research and development expenses for the three
months and year ended December 31, 2023 increased to $85.0 million
and $330.1 million, respectively, compared to $75.0 million and
$240.8 million for the same periods in 2022, respectively, due
primarily to spending on our cardiac myosin inhibitor programs.
General and administrative expenses for the
three and twelve months ended December 31, 2023 decreased
to $44.1 million and $173.6 million, respectively,
from $54.0 million and $178.0 million for the
same period in 2022 due to lower outside spending on commercial
readiness activities offset by higher personnel related costs
including stock-based compensation.
2024 Financial Guidance
The company today announced financial guidance
for 2024. The company anticipates revenue will be in the range of
$3 to $5 million, operating expenses will be in the range of $420
to 450 million, and net cash utilization will be approximately $390
to $420 million. Inclusive of approximately $83 million, net,
raised in early 2024 through our ATM equity vehicle, our year end
cash balance of $655.4 million, plus available long-term debt from
Royalty Pharma, represents approximately two years of forward cash
based on our projected 2024 operating expenses and net cash
utilization.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s fourth quarter 2023 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 Q4 2023 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 first-in-class muscle activators and
next-in-class muscle inhibitors 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. Aficamten is also currently being evaluated in two
ongoing Phase 3 clinical trials: MAPLE-HCM, evaluating aficamten as
monotherapy compared to metoprolol as monotherapy in patients with
obstructive HCM and ACACIA-HCM, evaluating aficamten in patients
with non-obstructive 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, and CK-136, a cardiac
troponin activator for the potential treatment HFrEF and other
types of heart failure, such as right ventricular failure resulting
from impaired cardiac contractility.
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 or a marketing authorisation
application for aficamten in the European Union, our ability to
obtain approval of our marketing authorisation application for
omecamtiv mecarbil in the E.U., 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, aficamten, 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.
Contact:Cytokinetics Diane
WeiserSenior Vice President, Corporate Communications, Investor
Relations(415) 290-7757
|
Cytokinetics, Incorporated |
Condensed Consolidated Balance Sheets |
(in thousands) |
|
|
|
|
|
|
|
|
December 31, 2023 |
|
December 31, 2022 |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and short-term investments |
|
$ |
614,824 |
|
|
$ |
782,577 |
|
Other current assets |
|
|
13,227 |
|
|
|
12,609 |
|
Total current assets |
|
|
628,051 |
|
|
|
795,186 |
|
Long-term investments |
|
|
40,534 |
|
|
|
46,708 |
|
Property and equipment, net |
|
|
68,748 |
|
|
|
80,453 |
|
Operating lease right-of-use assets |
|
|
78,987 |
|
|
|
82,737 |
|
Other assets |
|
|
7,996 |
|
|
|
9,691 |
|
Total assets |
|
$ |
824,316 |
|
|
$ |
1,014,775 |
|
LIABILITIES AND
STOCKHOLDERS’ DEFICIT |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
64,148 |
|
|
$ |
69,707 |
|
Short-term lease liability |
|
|
17,891 |
|
|
|
12,829 |
|
Current portion of long-term debt |
|
|
10,080 |
|
|
|
958 |
|
Other current liabilities |
|
|
10,559 |
|
|
|
1,123 |
|
Total current liabilities |
|
|
102,678 |
|
|
|
84,617 |
|
Term loan, net |
|
|
58,384 |
|
|
|
63,810 |
|
Convertible notes, net |
|
|
548,989 |
|
|
|
545,808 |
|
Liabilities related to revenue
participation right purchase agreements, net |
|
|
379,975 |
|
|
|
300,501 |
|
Long-term operating lease
liabilities |
|
|
120,427 |
|
|
|
126,895 |
|
Other non-current
liabilities |
|
|
186 |
|
|
|
1,044 |
|
Total liabilities |
|
|
1,210,639 |
|
|
|
1,122,675 |
|
Commitments and
contingencies |
|
|
|
|
Stockholders’ deficit: |
|
|
|
|
Common stock |
|
|
102 |
|
|
|
94 |
|
Additional paid-in capital |
|
|
1,725,823 |
|
|
|
1,481,590 |
|
Accumulated other comprehensive loss |
|
|
(10) |
|
|
|
(3,590) |
|
Accumulated deficit |
|
|
(2,112,238) |
|
|
|
(1,585,994) |
|
Total stockholders’ deficit |
|
|
(386,323) |
|
|
|
(107,900) |
|
Total liabilities and stockholders’ deficit |
|
$ |
824,316 |
|
|
$ |
1,014,775 |
|
Cytokinetics, Incorporated |
Condensed Consolidated Statements of
Operations |
(in thousands except per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Years Ended December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
Research and development revenues |
|
$ |
672 |
|
|
$ |
1,957 |
|
|
$ |
4,030 |
|
|
$ |
6,588 |
|
Milestone revenues |
|
|
1,000 |
|
|
|
— |
|
|
|
3,500 |
|
|
|
1,000 |
|
Realization of revenue participation right purchase agreement |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
87,000 |
|
Total revenues |
|
|
1,672 |
|
|
|
1,957 |
|
|
|
7,530 |
|
|
|
94,588 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
84,976 |
|
|
|
75,018 |
|
|
|
330,123 |
|
|
|
240,813 |
|
General and administrative |
|
|
44,114 |
|
|
|
53,969 |
|
|
|
173,612 |
|
|
|
177,977 |
|
Total operating expenses |
|
|
129,090 |
|
|
|
128,987 |
|
|
|
503,735 |
|
|
|
418,790 |
|
Operating loss |
|
|
(127,418) |
|
|
|
(127,030) |
|
|
|
(496,205) |
|
|
|
(324,202) |
|
Interest expense |
|
|
(7,164) |
|
|
|
(7,057) |
|
|
|
(28,306) |
|
|
|
(19,414) |
|
Loss on settlement of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(24,939) |
|
Non-cash interest expense on liabilities related to revenue
participation right purchase agreements |
|
|
(9,900) |
|
|
|
(9,212) |
|
|
|
(29,362) |
|
|
|
(31,742) |
|
Interest and other income, net |
|
|
7,586 |
|
|
|
5,919 |
|
|
|
27,629 |
|
|
|
11,342 |
|
Net loss before income
taxes |
|
|
(136,896) |
|
|
|
(137,380) |
|
|
|
(526,244) |
|
|
|
(388,955) |
|
Income tax benefit |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(136,896) |
|
|
$ |
(137,380) |
|
|
$ |
(526,244) |
|
|
$ |
(388,955) |
|
Net loss per share — basic and
diluted |
|
$ |
(1.38) |
|
|
$ |
(1.45) |
|
|
$ |
(5.45) |
|
|
$ |
(4.33) |
|
Weighted-average shares in net
loss per share — basic and diluted |
|
|
99,067 |
|
|
|
94,681 |
|
|
|
96,524 |
|
|
|
89,825 |
|
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Apr 2023 to Apr 2024