Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial
results for the fourth quarter and full year 2020. Net loss for the
fourth quarter was $43.9 million or $0.62 per share and the net
loss for the year 2020 was $127.3 million or $1.97 per share. Net
loss for the fourth quarter of 2019 was $30.6 million or $0.52 per
share and net loss for the year 2019 was $121.7 million or $2.11
per share. Cash, cash equivalents and investments totaled $501.0
million at December 31, 2020.
“In the fourth quarter, we were pleased to
present the results of GALACTIC-HF which demonstrated a positive
effect on the primary composite endpoint of cardiovascular death or
heart failure events in patients receiving standard of care plus
omecamtiv mecarbil, with potentially larger treatment effects in
patients with increasingly lower ejection fractions. In the next
few weeks, we plan to discuss the results of GALACTIC-HF with FDA
as may inform a potential registration path,” said Robert I. Blum,
Cytokinetics’ President and Chief Executive Officer. “In addition,
we recently progressed REDWOOD-HCM to Cohort 2 following a positive
interim analysis and we completed enrollment promptly afterwards.
Results from both cohorts are expected mid-year. We believe that we
are well positioned for what may be a transformational year for the
company as we approach potential commercialization of our first
medicine for patients with heart failure and we hope to advance two
other programs into pivotal clinical trials.”
Q4 and Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac
myosin activator)
- Results from GALACTIC-HF
(Global Approach to
Lowering Adverse
Cardiac Outcomes Through
Improving Contractility in
Heart Failure), the Phase 3
clinical trial of omecamtiv mecarbil, were presented and published
online.
- GALACTIC-HF demonstrated a
statistically significant effect of treatment with omecamtiv
mecarbil to reduce risk of the primary composite endpoint of
cardiovascular (CV) death or heart failure events (heart failure
hospitalization and other urgent treatment for heart failure)
compared to placebo in patients treated with standard of care.
- No reduction in the secondary
endpoint of time to CV death was observed and no other secondary
endpoints were met in accordance with the prespecified statistical
analysis.
- Adverse events and treatment
discontinuation of study drug were balanced between the treatment
arms. In general, the overall rates of myocardial ischemia,
ventricular arrhythmias and death were similar between treatment
and placebo groups.
- The effect of omecamtiv mecarbil
was consistent across most prespecified subgroups and with a
potentially greater treatment effect suggested in patients with a
lower left ventricular ejection fraction (LVEF).
- Supplemental analyses from
GALACTIC-HF were presented that demonstrated a greater treatment
effect of omecamtiv mecarbil in patients with lower LVEF as well as
characteristics that may indicate advanced heart failure, such as
being hospitalized within the last 3 months, higher N-terminal-pro
brain natriuretic peptide levels and lower blood pressures.
- Continued conduct of METEORIC-HF
(Multicenter Exercise
Tolerance Evaluation of
Omecamtiv Mecarbil Related to
Increased Contractility in
Heart Failure), the second Phase
3 trial of omecamtiv mecarbil.
- Presented findings from analyses of
claims data and electronic health records related to heart failure,
including analyses of the high spending and unmet need,
underscoring the growing economic burden of this disease.
- Conducted market research with
physicians and payors and continued other commercial planning
activities for omecamtiv mecarbil.
CK-3828136 (CK-136 (formerly
referred to as AMG 594), cardiac troponin activator)
- Analyzed data from the completed
Phase 1 study of CK-136 conducted by Amgen to inform next steps in
its development.
CK-3773274 (CK-274, cardiac
myosin inhibitor)
- Progressed REDWOOD-HCM
(Randomized Evaluation of
Dosing With CK-274 in
Obstructive Outflow
Disease in HCM), the Phase 2
clinical trial designed to determine the safety and tolerability of
CK-274 in patients with obstructive hypertrophic cardiomyopathy
(oHCM), to Cohort 2 following the conduct of an interim analysis of
data from Cohort 1. In December, we opened Cohort 2 in REDWOOD-HCM
to screening and it completed patient enrollment in February.
- The interim analysis of data from
Cohort 1 showed that patients experienced substantial reductions in
the average resting left ventricular outflow tract gradient
(LVOT-G) as well as the post-Valsalva LVOT-G. These clinically
relevant decreases in pressure gradients were achieved with only
modest decreases in average LVEF; there were no dose interruptions
due to LVEF falling below 50%. Pharmacokinetic data were similar to
data from Phase 1.
- Safety and tolerability data were
supportive of continued dose escalation with no serious adverse
events attributed to study treatment reported by the
investigators.
- Received approval of IND submitted
in China for conduct of a Phase 1 study of CK-274 under the License
and Collaboration Agreement between Cytokinetics and Ji Xing
Pharmaceuticals Limited.
- Presented preclinical data for
CK-274 showing that it reduced contractility and left ventricular
outflow tract peak pressure gradient in cats with naturally
occurring HCM and left ventricular outflow tract obstruction.
CK-3772271 (CK-271, second
cardiac myosin inhibitor)
- Presented preclinical data for
CK-271 demonstrating that, in the Dahl/Salt sensitive rat model of
heart failure with preserved ejection fraction (HFpEF), CK-271
attenuated the development of fibrosis and diastolic
dysfunction.
- Completed the planned Phase 1,
single-dose pharmacokinetic evaluation and tolerability assessments
of CK-271 in healthy volunteers and determined it to be suitable
for further development. We are evaluating its potential for
further development in connection with plans to conduct a broad
development program for our cardiac myosin inhibitor(s) in HCM and
other indications.
Skeletal Muscle Program
reldesemtiv (next-generation
fast skeletal muscle troponin activator (FSTA))
- Additional data from FORTITUDE-ALS,
the Phase 2 clinical trial of reldesemtiv in patients with ALS,
were presented showing that the effect of reldesemtiv was more
apparent in faster progressing patients, supporting the rationale
and design of COURAGE-ALS, the planned Phase 3 clinical trial of
reldesemtiv in patients with ALS.
- The design of COURAGE-ALS was also
presented, and we conducted readiness activities in preparation for
the potential start of the trial.
Pre-Clinical Development and Ongoing
Research
- Continued to develop new chemical
entities and to conduct IND enabling studies with the expectation
of our potentially advancing 1-2 potential drug candidates in
development.
- Continued research in collaboration
with Astellas directed to the discovery of next-generation skeletal
muscle activators under a joint research program extended through
March 31, 2021.
- Continued research activities
directed to our other muscle biology research programs which we
expect to continue in 2021.
Corporate
- Announced we will regain worldwide
rights to develop and commercialize omecamtiv mecarbil and CK-136
in May 2021.
- Named Nancy Wysenski and Muna
Bhanji to the company’s Board of Directors.
- Received $85 million upon the
closing of the sale of a royalty on mavacamten, being developed by
Bristol-Myers Squibb Company (formerly by MyoKardia, Inc.), to RTW
Royalty Holdings Designated Activity Company.
2021 Corporate Milestones
Cardiac Muscle Programs
omecamtiv
mecarbil (cardiac myosin activator)
- Plan to meet with FDA to discuss
GALACTIC-HF in Q1 2021.
- Expect enrollment in METEORIC-HF to
be completed in 1H 2021.
- Develop a “go-to-market” strategy
and potential commercial launch plan in 1H 2021.
CK-3773274 (CK-274, cardiac
myosin inhibitor)
- Expect a Phase 1 study of CK-274 in
China, conducted under the License and Collaboration Agreement
between Cytokinetics and Ji Xing Pharmaceuticals Limited, to start
in Q1 2021.
- Expect to begin an open label
extension study for patients who complete REDWOOD-HCM in Q2
2021.
- Expect to announce results from
both cohorts in REDWOOD-HCM by mid-year 2021.
- Plan to engage regulatory
authorities regarding a potential registration path in 2H
2021.
- Expect to begin a potential Phase 3
clinical trial of CK-274 by the end of 2021.
Skeletal Muscle Program
reldesemtiv (next-generation
fast skeletal muscle troponin activator (FSTA))
- We expect to conduct start-up
activities for COURAGE-ALS in 2021 and may open the trial to
enrollment in 2H 2021, subject to our plans relating to advancing
omecamtiv mecarbil towards commercialization and CK-274 to a
potential Phase 3 clinical trial in patients with oHCM.
Financials
Revenues for the three and twelve months ended
December 31, 2020 were $6.7 million and $55.8 million,
respectively, compared to $5.2 million and $26.9 million for the
corresponding periods in 2019. The increase in revenues for the
year ended December 31, 2020 was primarily due to $36.5 million of
license revenue recognized in the third quarter 2020 for the RTW
transactions.
Research and development expenses for the three
and twelve months ended December 31, 2020 increased to $29.2
million and $97.0 million, respectively, compared to $18.3 million
and $86.1 million for the same periods in 2019, respectively, due
primarily to increased spending for our cardiac myosin inhibitor
programs and increased spending on readiness for reldesemtiv offset
by a study that concluded on reldesemtiv in 2019.
General and administrative expenses for the
three and twelve months ended December 31, 2020 increased to $13.9
million and $52.8 million from $10.6 million and $39.6
million in 2019 due primarily to an increase in personnel
related costs including stock-based compensation and higher outside
spending for commercial readiness.
2021 Financial Guidance
The company today announced financial guidance
for 2021. The company anticipates revenue will be in the range of
$23 to $28 million, operating expenses will be in the range of $195
to $205 million, and net cash utilization will be approximately
$160 to 170 million. Our current cash balance of $501 million
represents more than two years of forward cash based on our
projected operating expenses and this net cash utilization range.
The net cash utilization range includes approximately $35 million
of non-recurring, building construction and related costs; it also
includes receipt of a potential $45 million from RTW Royalty
Holdings Designated Activity Company in exchange for a low single
digit royalty on CK-274 in connection with the funding agreement
signed in July 2020, subject to conditions for payment being
fulfilled. Should we not exercise our option to receive the $45
million, we expect our net cash utilization range will be
increased. We expect to revise our financial guidance mid-year once
we finalize strategies and potential commercial launch plans for
omecamtiv mecarbil. Significant additional expenses may arise from
our executing on those strategies and plans that are not included
in the current financial guidance.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s fourth quarter 2020 results via a webcast
and conference call today at 4:30 PM Eastern Time. The webcast can
be accessed through the Investors & Media section of the
Cytokinetics website at www.cytokinetics.com. The live audio of
the conference call can also be accessed by telephone by
dialing either (866) 999-CYTK (2985) (United States and Canada) or
+1 (706) 679-3078 (international) and typing in the
passcode 6555297.
An archived replay of the webcast will be
available via Cytokinetics’ website until March 11, 2021. The
replay will also be available via telephone by dialing (855)
859-2056 (United States and Canada) or +1 (404) 537-3406
(international) and typing in the passcode 6555297 from
February 25, 2021 at 7:30 PM Eastern Time until March 11, 2021.
About Cytokinetics
Cytokinetics is a late-stage 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 muscle performance is compromised and/or declining. As a
leader in muscle biology and the mechanics of muscle performance,
the company is developing small molecule drug candidates
specifically engineered to impact muscle function and
contractility. Cytokinetics is preparing for regulatory
interactions for omecamtiv mecarbil, its novel cardiac muscle
activator, following positive results from GALACTIC-HF, a large,
international Phase 3 clinical trial in patients with heart
failure. Cytokinetics is conducting METEORIC-HF, a second Phase 3
clinical trial of omecamtiv mecarbil. Cytokinetics is also
developing CK-274, a next-generation cardiac myosin inhibitor, for
the potential treatment of hypertrophic cardiomyopathies (HCM).
Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of
CK-274 in patients with obstructive HCM. Cytokinetics is also
developing reldesemtiv, a fast skeletal muscle troponin activator
for the potential treatment of ALS and other neuromuscular
indications following conduct of FORTITUDE-ALS and other Phase 2
clinical trials. The company is preparing for the potential
advancement of reldesemtiv to a Phase 3 clinical trial in ALS.
Cytokinetics continues its over 20-year history of pioneering
innovation in muscle biology and related pharmacology focused to
diseases of muscle dysfunction and conditions of muscle
weakness.
For additional information about Cytokinetics,
visit www.cytokinetics.com and follow us on Twitter, 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 are not limited to, statements relating to
Cytokinetics’ and its partners’ research and development and
commercial readiness activities, including the initiation, conduct,
design, enrollment, progress, continuation, completion, timing and
results of clinical trials, including the completion of enrollment
in METEORIC-HF in 1H 2021 and the release of results of METEORIC-HF
by the end of 2021, the availability of results from the first and
second cohorts of patients in REDWOOD-HCM by mid-year 2021, the
commencement of a Phase 3 clinical trial of CK-274 by year-end
2021, the significance and utility of pre-clinical study and
clinical trial results, including the results of GALACTIC-HF in
respect of omecamtiv mecarbil; the timing of interactions with
regulatory authorities in connection to any of Cytokinetics’ drug
candidates and the outcomes of such interactions, including
discussions related to the potential NDA submission and prospects
of regulatory approval for, and if approved, potential
commercialization of omecamtiv mecarbil and discussions in
preparation for a potential Phase 3 clinical trial and registration
program for reldesemtiv in patients with ALS; our decision to
engage in or execute, and the cost and expenses to be incurred in
connection with, any particular transition activities from Amgen
related to omecamtiv mecarbil and any particular commercial launch
readiness activities for omecamtiv mecarbil, including, but not
limited to, any development and regulatory activities associated
with the immunoassay used in GALACTIC-HF and METEORIC-HF and the
potential purchase of drug substance related to omecamtiv mecarbil,
the expected timing of events and milestones; the properties and
potential benefits of Cytokinetics’ drug candidates; and our
ability to meet any conditions required for the disbursement of $45
million under our funding agreement with RTW Royalty Holdings
Designated Activity Company. 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.
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.
Contact:Cytokinetics Diane
WeiserSenior Vice President, Corporate Communications, Investor
Relations(415) 290-7757
Cytokinetics, Incorporated Condensed
Consolidated Balance Sheets (in
thousands) |
|
|
|
|
|
December 31, 2020 |
|
December 31, 2019 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and short term investments |
$ |
464,060 |
|
|
$ |
225,112 |
|
Other current assets |
|
10,161 |
|
|
|
8,640 |
|
Total current assets |
|
474,221 |
|
|
|
233,752 |
|
Long-term investments |
|
36,954 |
|
|
|
42,650 |
|
Property and equipment, net |
|
13,346 |
|
|
|
4,530 |
|
Operating lease right-of-use assets and other assets |
|
9,282 |
|
|
|
8,882 |
|
Total assets |
$ |
533,803 |
|
|
$ |
289,814 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY (DEFICIT) |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued liabilities |
$ |
27,365 |
|
|
$ |
20,283 |
|
Short-term lease liability |
|
2,785 |
|
|
|
4,616 |
|
Other current liabilities |
|
1,049 |
|
|
|
1,124 |
|
Total current liabilities |
|
31,199 |
|
|
|
26,023 |
|
Term loan, net |
|
46,209 |
|
|
|
45,052 |
|
Convertible notes, net |
|
89,504 |
|
|
|
84,205 |
|
Liability related to the sale of
future royalties, net |
|
166,068 |
|
|
|
143,276 |
|
Long-term deferred revenue |
|
87,000 |
|
|
|
— |
|
Long-term lease liability |
|
440 |
|
|
|
2,195 |
|
Total liabilities |
|
420,420 |
|
|
|
300,751 |
|
Commitments and
contingencies |
|
|
|
Stockholders’ equity
(deficit): |
|
|
|
Common stock |
|
70 |
|
|
|
59 |
|
Additional paid-in capital |
|
1,105,470 |
|
|
|
853,341 |
|
Accumulated other comprehensive income |
|
149 |
|
|
|
679 |
|
Accumulated deficit |
|
(992,306 |
) |
|
|
(865,016 |
) |
Total stockholders’ equity (deficit) |
|
113,383 |
|
|
|
(10,937 |
) |
Total liabilities and stockholders’ equity (deficit) |
$ |
533,803 |
|
|
$ |
289,814 |
|
Cytokinetics, Incorporated Condensed
Consolidated Statements of Operations (in
thousands except per share
data) (unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Years Ended December 31, |
|
2020 |
|
2019 |
|
2018 |
|
2020 |
|
2019 |
|
2018 |
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
Research and development revenues |
$ |
4,222 |
|
|
$ |
5,212 |
|
|
$ |
9,377 |
|
|
$ |
16,527 |
|
|
$ |
26,868 |
|
|
$ |
26,368 |
|
License revenues |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
36,501 |
|
|
|
— |
|
|
|
5,133 |
|
Milestone revenues |
|
2,500 |
|
|
|
— |
|
|
|
— |
|
|
|
2,800 |
|
|
|
— |
|
|
|
— |
|
Total revenues |
|
6,722 |
|
|
|
5,212 |
|
|
|
9,377 |
|
|
|
55,828 |
|
|
|
26,868 |
|
|
|
31,501 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
29,221 |
|
|
|
18,334 |
|
|
|
23,278 |
|
|
|
96,951 |
|
|
|
86,125 |
|
|
|
89,135 |
|
General and administrative |
|
13,908 |
|
|
|
10,584 |
|
|
|
7,558 |
|
|
|
52,820 |
|
|
|
39,610 |
|
|
|
31,282 |
|
Total operating expenses |
|
43,129 |
|
|
|
28,918 |
|
|
|
30,836 |
|
|
|
149,771 |
|
|
|
125,735 |
|
|
|
120,417 |
|
Operating loss |
|
(36,407 |
) |
|
|
(23,706 |
) |
|
|
(21,459 |
) |
|
|
(93,943 |
) |
|
|
(98,867 |
) |
|
|
(88,916 |
) |
Interest expense |
|
(4,018 |
) |
|
|
(2,731 |
) |
|
|
(1,170 |
) |
|
|
(15,963 |
) |
|
|
(6,623 |
) |
|
|
(3,797 |
) |
Non-cash interest expense on liability related to sale of future
royalties |
|
(5,651 |
) |
|
|
(5,533 |
) |
|
|
(4,740 |
) |
|
|
(22,713 |
) |
|
|
(20,737 |
) |
|
|
(17,767 |
) |
Interest and other income, net |
|
2,146 |
|
|
|
1,330 |
|
|
|
900 |
|
|
|
5,329 |
|
|
|
4,535 |
|
|
|
4,191 |
|
Net loss before income taxes |
|
(43,930 |
) |
|
|
(30,640 |
) |
|
|
(26,469 |
) |
|
|
(127,290 |
) |
|
|
(121,692 |
) |
|
|
(106,289 |
) |
Income tax benefit |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
$ |
(43,930 |
) |
|
$ |
(30,640 |
) |
|
$ |
(26,469 |
) |
|
$ |
(127,290 |
) |
|
$ |
(121,692 |
) |
|
$ |
(106,289 |
) |
Net loss per share — basic and
diluted |
$ |
(0.62 |
) |
|
$ |
(0.52 |
) |
|
$ |
(0.48 |
) |
|
$ |
(1.97 |
) |
|
$ |
(2.11 |
) |
|
$ |
(1.95 |
) |
Weighted-average shares in net
loss per share — basic and diluted |
|
70,833 |
|
|
|
59,133 |
|
|
|
54,689 |
|
|
|
64,524 |
|
|
|
57,575 |
|
|
|
54,420 |
|
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