Company Provides 2019 Financial Guidance and
Expected Milestones
Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial
results for 2018. Net loss for 2018 was $106 million, or $1.95 per
share, compared to net loss for 2017 of $128 million, or $2.59 per
share. Cash, cash equivalents and investments totaled $199 million
at December 31, 2018.
“We had a productive fourth quarter 2018
highlighted by the expansion of our clinical pipeline of
muscle-directed investigational medicines and the advancement of
our wholly-owned cardiac myosin inhibitor which we are developing
for the potential treatment of patients with hypertrophic
cardiomyopathies,” said Robert I. Blum, Cytokinetics’ President and
Chief Executive Officer. “Our progress is continuing with the
achievement of key milestones under our partnered programs. Under
our collaboration with Amgen, we recently opened METEORIC-HF to
enrollment and expect GALACTIC-HF to complete enrollment in the
next few months. In that same timeframe, we are also looking
forward to results from FORTITUDE-ALS under our collaboration with
Astellas. We believe that our pioneering leadership in muscle
biology, alongside our partnerships and current financials,
position us well for upcoming company milestones.”
Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac
myosin activator)
- Continued enrollment in GALACTIC-HF (Global
Approach to Lowering
Adverse Cardiac Outcomes
Through Improving
Contractility in Heart
Failure), the Phase 3 cardiovascular outcomes
clinical trial of omecamtiv mecarbil. Enrollment is nearing 90
percent completion with over 7,000 patients randomized to date
having the high-risk profile intended by the trial design.
GALACTIC-HF is being conducted by Amgen in collaboration with
Cytokinetics.
- Opened METEORIC-HF, (Multicenter
Exercise Tolerance
Evaluation of Omecamtiv Mecarbil
Related to Increased
Contractility in Heart
Failure), the second Phase 3 trial of omecamtiv
mecarbil. METEORIC-HF is a randomized, placebo-controlled,
double-blind, parallel group, multicenter clinical trial designed
to evaluate the effect of treatment with omecamtiv mecarbil
compared to placebo on exercise capacity as determined by
cardiopulmonary exercise testing (CPET) following 20 weeks of
treatment. METEORIC-HF is being conducted by Cytokinetics in
collaboration with Amgen.
AMG 594 (cardiac troponin
activator)
- Began dosing in the Phase 1 study of AMG 594 to assess its
safety, tolerability, pharmacokinetics and potential to increase
cardiac function in healthy volunteers. AMG 594 is a novel,
selective, oral, small molecule cardiac troponin activator,
discovered under a joint research program with Amgen. This Phase 1
study is being conducted by Amgen in collaboration with
Cytokinetics.
CK-3773274 (CK-274, cardiac
myosin inhibitor)
- Continued enrollment in a Phase 1 double-blind, randomized,
placebo-controlled, multi-part, single and multiple ascending dose
clinical study of CK-274 in healthy adult subjects. CK-274 is a
wholly-owned, novel cardiac myosin inhibitor, discovered by company
scientists, in development for the potential treatment of
hypertrophic cardiomyopathy (HCM).
Skeletal Muscle Program
reldesemtiv (next-generation
fast skeletal muscle troponin activator (FSTA))
- Received feedback from the U.S. Food and Drug Administration
that the Six Minute Walk Test is an acceptable primary endpoint for
a potential registration program for reldesemtiv in ambulatory
patients with SMA.
- Completed patient enrollment in FORTITUDE-ALS
(Functional Outcomes in a
Randomized Trial of
Investigational Treatment with
CK-2127107 to Understand Decline
in Endpoints – in ALS), the Phase
2 clinical trial designed to assess the change from baseline in the
percent predicted slow vital capacity and other measures of
skeletal muscle function after 12 weeks of treatment with
reldesemtiv in patients with ALS. This Phase 2 trial is being
conducted by Cytokinetics in collaboration with
Astellas.
- Announced data from FORTITUDE-ALS at the 29th International
Symposium on ALS/MND in Glasgow, Scotland, UK, including patient
baseline characteristics and demographics. Baseline
characteristics of patients enrolled in FORTITUDE-ALS are similar
to those of other recent large clinical trials in ALS, including
BENEFIT-ALS and VITALITY-ALS.
Pre-Clinical Development and Ongoing
Research
- Continued pre-clinical development of CK-3762601 (CK-601), a
next-generation FSTA, under our collaboration with Astellas.
- Continued research in collaboration with Astellas directed to
the discovery of next-generation skeletal muscle activators; The
companies are continuing their joint research program with Astellas
providing sponsorship of Cytokinetics' activities through
2019.
- Continued independent research activities directed to our other
muscle biology research programs.
Corporate
- Convened an R&D Day to provide an update on our expanded
pipeline of muscle-directed drug candidates.
Financials
Revenues for 2018 included $29.4 million in
revenue from our collaboration with Astellas and $1.9 million from
our collaboration with Amgen. Revenues from Astellas in 2018
included $22.3 million for reimbursement of research and
development expenses, $5.1 million in license revenue and $2.0
million in a milestone payment. Revenues from Amgen in 2018 include
$1.9 million for reimbursement of research and development
expenses. Revenues for 2017 were offset by $20.0 million for
payments to Amgen related to our option to co-fund the Phase 3
development program of omecamtiv mecarbil in exchange for an
increased royalty upon potential commercialization.
Research and development expenses decreased to
$89.1 million in 2018 from $90.3 million in 2017, primarily due to
the suspension of development of tirasemtiv in late 2017, offset in
part by increased development activities for reldesemtiv and
CK-274.
General and administrative expenses decreased to
$31.3 million in 2018 from $36.5 million in 2017, primarily due to
decreased commercial readiness activities.
2019 Financial Guidance
The company also announced financial guidance
for 2019. The company anticipates cash revenue will be in the range
of $28 to $32 million, operating expenses will be in the range of
$110 to $115 million, and net cash utilization will be
approximately $85 to $90 million.
2019 Corporate Milestones
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin
activator)
- Expect to complete patient enrollment in GALACTIC-HF in the
first half of 2019.
- Expect the Data Monitoring Committee to conduct a first interim
analysis for GALACTIC-HF, the design of which is tied to the
potential for futility, in the first half of 2019.
- Expect to continue patient enrollment in METEORIC-HF through
2019.
AMG 594 (cardiac troponin
activator)
- Expect the continued conduct of the Phase 1 study of AMG 594
through 2019.
CK-3773274 (CK-274, cardiac
myosin inhibitor)
- Expect data from a Phase 1 study of CK-274 in the second half
of 2019.
Skeletal Muscle Program
reldesemtiv (next-generation
FSTA)
- Expect results from FORTITUDE-ALS in Q2 2019.
Pre-Clinical Research
- Expect to continue joint research program with Astellas through
2019.
- Expect to continue independent research activities directed to
our other muscle biology research programs through 2019.
Conference Call and Webcast
Information
Members of Cytokinetics’ senior management team
will review the company’s fourth quarter 2018 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
(706) 679-3078 (international) and typing in the
passcode 9798766.
An archived replay of the webcast will be
available via Cytokinetics’ website until February 28,
2019. The replay will also be available via telephone by
dialing (855) 859-2056 (United States and Canada) or (404) 537-3406
(international) and typing in the passcode 9798766 from
February 21, 2019 at 7:30 PM Eastern Time until February 28,
2019.
About Cytokinetics
Cytokinetics is a late-stage
biopharmaceutical company focused on discovering, developing and
commercializing first-in-class muscle activators and best-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 collaborating
with Amgen Inc. (Amgen) to develop omecamtiv
mecarbil, a novel cardiac muscle activator. Omecamtiv
mecarbil is the subject of an international clinical trials
program in patients with heart failure including GALACTIC-HF and
METEORIC-HF. Amgen holds an exclusive worldwide license to
develop and commercialize omecamtiv mecarbil with a
sublicense held by Servier for commercialization
in Europe and certain other
countries. Cytokinetics is also collaborating
with Amgen to develop AMG 594, a first-in-class cardiac
troponin activator, discovered under the companies’ joint research
program. Further development of AMG 594 is subject to the
collaboration agreement
between Amgen and Cytokinetics. Cytokinetics is
collaborating with Astellas Pharma Inc. (Astellas) to
develop reldesemtiv, a fast skeletal muscle troponin activator
(FSTA). Reldesemtiv has been granted orphan drug
designation by the FDA for the potential treatment of
spinal muscular atrophy. Reldesemtiv was the subject of a
positive Phase 2 clinical study in patients with spinal muscular
atrophy which showed increases in measures of endurance and stamina
consistent with the mechanism of action. Reldesemtiv is
currently the subject of FORTITUDE-ALS, a Phase 2 clinical trial in
patients with amyotrophic lateral sclerosis. Cytokinetics is
also advancing CK-601, a next-generation FSTA, under the
collaboration with Astellas. Astellas holds an exclusive worldwide
license to develop and commercialize reldesemtiv. Licenses
held by Amgen and Astellas are subject to specified
co-development and co-commercialization rights
of Cytokinetics. Cytokinetics is also developing
CK-274, a novel cardiac myosin inhibitor that company scientists
discovered independent of its collaborations, for the potential
treatment of hypertrophic cardiomyopathies.
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.
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
activities, including the initiation, conduct, design, enrollment,
progress, continuation, completion, timing and results of clinical
trials; the significance and utility of pre-clinical study and
clinical trial results; planned interactions with regulatory
authorities and the outcomes of such interactions; the expected
timing of events and milestones, including the receipt of milestone
payments; and the properties and potential benefits of
Cytokinetics’ drug candidates. 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; Amgen’s and Astellas’ decisions with
respect to the design, initiation, conduct, timing and continuation
of development activities for omecamtiv mecarbil and reldesemtiv,
respectively; 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:Diane WeiserVice
President, Corporate Communications, Investor Relations(415)
290-7757
Cytokinetics,
IncorporatedCondensed Consolidated Statements of
Operations(in thousands, except per share
data)(unaudited)
|
Three Months Ended December 31, |
|
|
Years Ended December 31, |
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development, milestone, grant and other revenues, net |
$ |
9,377 |
|
|
$ |
(5,234 |
) |
|
$ |
26,368 |
|
|
$ |
4,569 |
|
License
revenues |
|
— |
|
|
|
5,216 |
|
|
|
5,133 |
|
|
|
8,799 |
|
Total
revenues |
|
9,377 |
|
|
|
(18 |
) |
|
|
31,501 |
|
|
|
13,368 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
23,278 |
|
|
|
26,250 |
|
|
|
89,135 |
|
|
|
90,296 |
|
General and
administrative |
|
7,558 |
|
|
|
10,259 |
|
|
|
31,282 |
|
|
|
36,468 |
|
Total
operating expenses |
|
30,836 |
|
|
|
36,509 |
|
|
|
120,417 |
|
|
|
126,764 |
|
Operating loss |
|
(21,459 |
) |
|
|
(36,527 |
) |
|
|
(88,916 |
) |
|
|
(113,396 |
) |
Interest
expense |
|
(1,170 |
) |
|
|
(670 |
) |
|
|
(3,797 |
) |
|
|
(3,016 |
) |
Non-cash
interest expense on liability related to sale of future
royalties |
|
(4,740 |
) |
|
|
(4,061 |
) |
|
|
(17,767 |
) |
|
|
(13,980 |
) |
Interest and
other income, net |
|
900 |
|
|
|
774 |
|
|
|
4,191 |
|
|
|
2,602 |
|
Net loss |
$ |
(26,469 |
) |
|
$ |
(40,484 |
) |
|
$ |
(106,289 |
) |
|
$ |
(127,790 |
) |
Net loss per share |
$ |
(0.48 |
) |
|
$ |
(0.75 |
) |
|
$ |
(1.95 |
) |
|
$ |
(2.59 |
) |
Weighted-average shares in
net loss per share |
|
54,689 |
|
|
|
53,929 |
|
|
|
54,420 |
|
|
|
49,404 |
|
Cytokinetics,
IncorporatedCondensed Consolidated Balance Sheets
(in thousands)
|
|
December 31, 2018 |
|
|
December 31,
2017(1) |
|
|
|
(unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
short term investments |
|
$ |
198,731 |
|
|
$ |
268,891 |
|
Other
current assets |
|
|
8,943 |
|
|
|
5,404 |
|
Total
current assets |
|
|
207,674 |
|
|
|
274,295 |
|
Long-term
investments |
|
|
— |
|
|
|
16,518 |
|
Property and
equipment, net |
|
|
3,204 |
|
|
|
3,568 |
|
Other
assets |
|
|
300 |
|
|
|
429 |
|
Total
assets |
|
$ |
211,178 |
|
|
$ |
294,810 |
|
LIABILITIES AND
STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities |
|
$ |
19,521 |
|
|
$ |
22,645 |
|
Deferred
revenue, current |
|
|
— |
|
|
|
9,572 |
|
Current
portion of long-term debt |
|
|
2,607 |
|
|
|
— |
|
Other
current liabilities |
|
|
66 |
|
|
|
227 |
|
Total
current liabilities |
|
|
22,194 |
|
|
|
32,444 |
|
Long-term debt, net |
|
|
39,806 |
|
|
|
31,777 |
|
Liability related to the
sale of future royalties, net |
|
|
122,473 |
|
|
|
104,650 |
|
Deferred revenue,
non-current |
|
|
— |
|
|
|
15,000 |
|
Other long-term
liabilities |
|
|
771 |
|
|
|
1,097 |
|
Total
liabilities |
|
|
185,244 |
|
|
|
184,968 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock
and additional paid-in capital |
|
|
768,758 |
|
|
|
755,580 |
|
Accumulated
other comprehensive income |
|
|
500 |
|
|
|
343 |
|
Accumulated
deficit |
|
|
(743,324 |
) |
|
|
(646,081 |
) |
Total
stockholders’ equity |
|
|
25,934 |
|
|
|
109,842 |
|
Total
liabilities and stockholders’ equity |
|
$ |
211,178 |
|
|
$ |
294,810 |
|
(1) Derived from the audited financial statements,
included in the company’s Annual Report on Form 10-K for the year
ended December 31, 2017.
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Feb 2024 to Mar 2024
Cytokinetics (NASDAQ:CYTK)
Historical Stock Chart
From Mar 2023 to Mar 2024