Cytokinetics, Incorporated Reports Fourth Quarter 2014 Financial Results
(Thomson Reuters ONE) -
Ongoing Regulatory Interactions in US and Europe Inform Progression of
Tirasemtiv to Phase III
COSMIC-HF Nears Completion of Enrollment with Results Expected Later This Year
Company Exceeded Financial Guidance in 2014 and Provides Milestones and
Financial Guidance for 2015
SOUTH SAN FRANCISCO, CA, February 12, 2015 - Cytokinetics, Incorporated (Nasdaq:
CYTK) reported total research and development revenues for the fourth quarter of
2014 were $21.8 million, compared to $24.3 million during the same period in
2013. The net income for the fourth quarter was $8.4 million, or $0.23 per
basic and diluted share. This is compared to a net income for the same period in
2013, of $6.5 million, or $0.22 per basic share and $0.21 per diluted share. As
of December 31, 2014, cash, cash equivalents and investments totaled $83.2
million, which includes the receipt of $10 million for the sale of common stock
to Astellas Pharma Inc., but does not include $45.0 million received from
Astellas in January 2015. With the recognition of a milestone payment under its
collaboration agreement with Astellas, the company exceeded its 2014 financial
guidance.
"The recent expansion of our collaboration agreement with Astellas enables
Cytokinetics to advance CK-2127107 into a Phase II trial in 2015 as well as the
financial leverage to capitalize on other pipeline progress," stated Robert I.
Blum, Cytokinetics' President and Chief Executive Officer. "Regulatory
interactions over the last few months in both the United States and Europe
inform a path forward for tirasemtiv to Phase III in patients with ALS. In
addition, we are nearing completion of enrollment in COSMIC-HF, enabling the
reporting of key data relating to omecamtiv mecarbil in chronic heart failure
patients later this year. Taken all together, we have entered 2015 well
positioned to achieve on program milestones relating to our first-in-class drug
candidates directed to augmenting muscle function across multiple therapeutic
categories."
Company Highlights
Skeletal Muscle Contractility
tirasemtiv
* Cytokinetics recently attended meetings with regulatory authorities in both
the United States and Europe to discuss the results of BENEFIT-ALS and
potential plans to advance tirasemtiv to Phase III. While regulatory
interactions are ongoing, the company believes that current feedback enables
advancement of tirasemtiv to a Phase III clinical development program that
is designed to potentially confirm and extend results from BENEFIT-ALS.
Objectives of the Phase III program will include measures of respiratory
function after longer duration treatment in patients with amyotrophic
lateral sclerosis (ALS), including effects on Slow Vital Capacity (SVC).
* Cytokinetics has initiated non-clinical and clinical development planning
activities for the Phase III program.
CK-2127107
* During the quarter, Cytokinetics conducted development activities for CK-
2127107 in accordance with an agreed plan under the joint oversight of the
company and Astellas. These development activities included manufacturing
of CK-2127107, review of results from pre-clinical and Phase I clinical
studies with CK-2127107 and other planning for the progression of CK-
2127107 to Phase II clinical development.
Cardiac Muscle Contractility
omecamtiv mecarbil
* During the quarter, enrollment continued in the expansion phase of COSMIC-HF
(Chronic Oral Study of Myosin Activation to Increase Contractility
in Heart Failure). COSMIC-HF is a Phase II, double-blind, randomized,
placebo-controlled, multicenter clinical trial designed to assess the
pharmacokinetics and tolerability of omecamtiv mecarbil dosed orally in
patients with heart failure and left ventricular systolic dysfunction as
well as its effects on echocardiographic measures of cardiac function. The
expansion phase of COSMIC-HF has enrolled over 400 patients towards the
total of 450 patients planned for this phase of the trial. Over 150 patients
have completed dosing in the expansion phase of COSMIC-HF. This trial is
being conducted by Amgen in collaboration with Cytokinetics.
* Recently, a manuscript titled, "Safety and Tolerability of Omecamtiv
Mecarbil During Exercise in Patients With Ischemic Cardiomyopathy and
Angina" was published in the journal JACC Heart Failure. This manuscript
highlights the results from a previously reported Phase IIa clinical trial
designed to evaluate the safety and tolerability of treatment of omecamtiv
mecarbil during symptom-limited exercise in patients with ischemic
cardiomyopathy and angina. The publication concluded that doses of
omecamtiv mecarbil, which produce plasma concentrations previously shown to
increase systolic function, were well tolerated during exercise in patients
with ischemic cardiomyopathy and angina who were evaluated in this trial and
that there was no indication that omecamtiv mecarbil increased the
likelihood of myocardial ischemia in this high-risk population.
Pre-Clinical Research
* During the quarter, Cytokinetics continued to conduct research under our
joint research program with Amgen directed to the discovery of next-
generation cardiac sarcomere activators, and under our joint research
program with Astellas directed to the discovery of next-generation skeletal
muscle activators. In addition, the company continued research activities
directed to other muscle biology programs.
Corporate
* During the quarter, Cytokinetics amended its strategic collaboration with
Astellas focused on the research, development and commercialization of
skeletal muscle activators. The expansion of the collaboration enables the
development of CK-2127107 in spinal muscular atrophy (SMA) and potentially
other neuromuscular indications. Cytokinetics and Astellas will jointly
develop and may jointly commercialize CK-2127107 and other fast skeletal
troponin activators in neuromuscular indications in designated countries.
Cytokinetics and Astellas extended their joint research program focused on
the discovery of additional skeletal sarcomere activators through 2016.
Cytokinetics has recently received $55 million from Astellas comprised of
$30 million as an upfront license fee in connection with the execution of
the amended collaboration agreement, $10 million paid for Astellas' purchase
of Cytokinetics' common stock and $15 million in a milestone payment in
connection with the decision made by Astellas to advance CK-2127107 into
Phase II clinical development. Cytokinetics expects to receive potentially
over $20 million payable by Astellas to reimburse Cytokinetics for planned
research and development expenses over the next 2 years. Under the amended
agreement, Cytokinetics is eligible to receive over $600 million in pre-
commercialization and commercialization milestone payments, of which over
$100 million is payable for CK-2127107 in each of SMA and other
neuromuscular indications. The agreed terms also provide for escalating
royalties to Cytokinetics with increased sales. Cytokinetics retains the
option to co-fund the development of CK-2127107 in SMA and other
neuromuscular indications in exchange for increased milestone payments and
royalties and, if Cytokinetics exercises its co-promotion option, Astellas
will reimburse Cytokinetics for certain expenses associated with its
promotion activities.
Financials
Revenues for the fourth quarter of 2014 were $21.8 million, compared to $24.3
million during the same period in 2013. Revenues for the fourth quarter of 2014
included $2.3 million of license revenues, $3.3 million of research and
development revenues, and $15.0 million in milestone revenues from our
collaboration with Astellas, $1.1 million in research and development revenues
from our collaboration with Amgen, and $0.1 million in milestone revenues from
our collaboration with MyoKardia. Revenues for the same period in 2013 included
$2.4 million of license revenues and $4.1 million of research and development
revenues from our collaboration with Astellas, and $17.2 million of license
revenues and $0.6 million of research and development revenues from our
collaboration with Amgen.
Total research and development (R&D) expenses for the fourth quarter of 2014
were $8.8 million, compared with $13.8 million for the same period in 2013. The
$5.0 million decrease in R&D expenses for the fourth quarter of 2014, compared
with the same period in 2013, was primarily due to a decrease of $5.9 million in
outsourced clinical and preclinical costs partially offset by an increase of
$0.6 million in personnel expenses and an increase of $0.2 million in laboratory
expenses.
Total general and administrative (G&A) expenses for the fourth quarter of 2014
were $4.6 million, compared with $4.1 million for the same period in 2013. The
$0.5 million increase in G&A expenses in the fourth quarter of 2014, compared
with the same period in 2013, was primarily due to an increase of $0.6 million
in legal expenses and $0.5 million in personnel expenses, partially offset by a
decrease of $0.6 million in outsourced expenses.
Revenues for the twelve months ended December 31, 2014 were $46.9 million,
compared to $30.6 million for the same period in 2013. Revenues for the twelve
months of 2014 were primarily comprised of $15.4 million of research and
development revenues, $9.8 million of license revenues and $17.0 million in
milestone revenues from our collaboration with Astellas, $4.5 million of
research and development revenues from our collaboration with Amgen and $0.1
million in milestone revenue from our collaboration with MyoKardia. Revenues for
the same period in 2013 primarily comprised of $3.9 million of license revenues
and $6.4 million of research and development revenues from our collaboration
with Astellas and $17.2 million of license revenue and $2.0 million of research
and development revenues from our collaboration with Amgen, and $1.0 million in
revenue from our collaboration with MyoKardia.
Total R&D expenses for the twelve months ended December 31, 2014 were $44.4
million, compared to $49.5 million for the same period in 2013. The $5.1 million
decrease in R&D expenses for the twelve months of 2014, compared the same period
in 2013, was primarily due to decreased spending of $8.2 million for outsourced
clinical and preclinical costs, partially offset by increased spending of $2.6
million in personnel-related costs.
Total G&A expenses for the twelve months ended December 31, 2014 were $17.3
million, compared to $15.1 million for the same period in 2013. The $2.2 million
increase in G&A spending for the twelve months of 2014, compared to the same
period in 2013, was primarily due to increased spending for personnel-related
costs and outside services.
The net loss for the twelve months ended December 31, 2014 was $(14.6) million,
or $(0.41) per basic and diluted share, compared to a net loss of $(33.7)
million or $(1.24) per basic and diluted share, for the same period in 2013.
Financial Guidance
Cytokinetics also announced its financial guidance for 2015. The company
anticipates cash revenue will be in the range of $40 to $43 million, cash R&D
expenses will be in the range of $55 to $58 million, and cash G&A expenses will
be in the range of $15 to $18 million. This guidance includes approximately $30
million in revenue which will be deferred and recognized over a two year period
ending in 2016 under generally accepted accounting principles. This guidance
excludes the $15 million milestone payment earned in 2014 from Astellas and an
estimated $3.6 million in non-cash related operating expenses primarily related
to stock compensation expense.
Company Milestones
Skeletal Muscle Contractility
tirasemtiv
* Cytokinetics expects to initiate a Phase III clinical development program
for tirasemtiv in patients with ALS in the second quarter of 2015.
CK-2127107
* Cytokinetics expects to initiate a Phase II trial of CK-2127107 in patients
with SMA in the second half of 2015.
Cardiac Muscle Contractility
omecamtiv mecarbil
* Cytokinetics expects enrollment of patients in the expansion phase of
COSMIC-HF to conclude in the first quarter of 2015 and results from COSMIC-
HF to be available in the second half of 2015.
* Cytokinetics expects to continue joint development activities in
collaboration with Amgen directed to the potential advancement of omecamtiv
mecarbil to Phase III clinical development.
Conference Call and Webcast Information
Members of Cytokinetics' senior management team will review the company's fourth
quarter results via a webcast and conference call today at 4:30 PM Eastern Time.
The webcast can be accessed through the Homepage and Investor Relations 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 34459599.
An archived replay of the webcast will be available via Cytokinetics' website
until February 19, 2015. 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 34459599 from February 12, 2015 at
5:30 PM Eastern Time until February 19, 2015.
About Cytokinetics
Cytokinetics is a clinical-stage biopharmaceutical company focused on the
discovery and development of novel small molecule therapeutics that modulate
muscle function for the potential treatment of serious diseases and medical
conditions. Cytokinetics is developing tirasemtiv, a fast skeletal muscle
activator, as a potential treatment for amyotrophic lateral sclerosis (ALS).
Tirasemtiv has been granted orphan drug designation and fast track status by the
U.S. Food and Drug Administration and orphan medicinal product designation by
the European Medicines Agency for the potential treatment of ALS. Cytokinetics
is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a cardiac muscle
activator, for the potential treatment of heart failure. Cytokinetics is
collaborating with Astellas Pharma Inc. to develop CK-2127107, a skeletal muscle
activator, for spinal muscular atrophy. Amgen holds an exclusive license
worldwide to develop and commercialize omecamtiv mecarbil and Astellas holds an
exclusive license worldwide to develop and commercialize CK-2127107. Both
licenses are subject to Cytokinetics' specified development and
commercialization participation rights. All of these drug candidates have
arisen from Cytokinetics' muscle biology focused research activities and are
directed towards the cytoskeleton. The cytoskeleton is a complex biological
infrastructure that plays a fundamental role within every human cell. Additional
information about Cytokinetics can be obtained at http://www.cytokinetics.com/.
Forward-Looking Statements
This press release contains forward-looking statements for purposes of the
Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics
disclaims any intent or obligation to update these forward-looking statements,
and 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 expected revenue and R&D and G&A expenses; Cytokinetics'
and its partners' research and development activities, including the initiation,
conduct, design, enrollment, progress, continuation, completion and results of
clinical trials, the significance and utility of clinical trial results, the
expected availability of clinical trial results, planned interactions with
regulatory authorities and the outcomes of such interactions, the potential
conduct of a Phase III clinical trial of tirasemtiv and the timing for the
initiation of such a trial; the use of effects on slow vital capacity as a Phase
III clinical trial endpoint for tirasemtiv; the potential progression of CK-
2127107 to Phase II development and omecamtiv mecarbil to Phase III development;
potential milestone payments, royalties and other payments; the expected roles
of Cytokinetics and Astellas under the collaboration and in developing or
commercializing drug candidates or products subject to the collaboration; the
indications to be pursued under the Astellas collaboration; the expected timing
of events; 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 further clinical development of tirasemtiv in ALS
patients which will require significant additional funding, and Cytokinetics may
be unable to obtain such additional funding on acceptable terms, if at all; the
FDA and/or other regulatory authorities may not accept effects on slow vital
capacity as a clinical endpoint to support registration of tirasemtiv for the
treatment of ALS; additional Phase I clinical trials for CK-2127107 may be
required; 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, including risks that current
and past results of clinical trials or preclinical studies may not be indicative
of future clinical trials results, patient enrollment for or conduct of clinical
trials may be difficult or delayed, Cytokinetics' drug candidates may have
adverse side effects or inadequate therapeutic efficacy, the U.S. Food and Drug
Administration or foreign regulatory agencies may delay or limit Cytokinetics'
or its partners' ability to conduct clinical trials, and Cytokinetics may be
unable to obtain or maintain patent or trade secret protection for its
intellectual property; Amgen's and Astellas' decisions with respect to the
design, initiation, conduct, timing and continuation of development activities
for omecamtiv mecarbil and CK-2127107, respectively; Cytokinetics may incur
unanticipated research and development and other costs or be unable to obtain
additional financing necessary to conduct development of its products;
Cytokinetics may be unable to enter into future collaboration agreements for its
drug candidates and programs on acceptable terms, if at all; standards of care
may change, rendering Cytokinetics' drug candidates obsolete; competitive
products or alternative therapies may be developed by others for the treatment
of indications Cytokinetics' drug candidates and potential drug candidates may
target; and risks and uncertainties relating to the timing and receipt of
payments from its partners, including milestones and royalties on future
potential product sales under Cytokinetics' collaboration agreements with such
partners. For further information regarding these and other risks related to
Cytokinetics' business, investors should consult Cytokinetics' filings with the
Securities and Exchange Commission.
Contact:
Joanna L. Goldstein
Manager, Investor Relations & Corporate Communications
(650) 624-3000
Cytokinetics, Incorporated
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
Three Months Ended Year Ended
-------------------------- -------------------------
December December December December
31, 31, 31, 31,
2014 2013((1)) 2014 2013((1))
------------ ------------ ------------ ------------
Revenues:
Research and development
revenues from related
parties $ 16,110 $ 564 $ 19,538 $ 2,019
Research and development,
grant and other revenues 3,377 4,113 17,566 7,547
License revenues from
related parties - 17,230 - 17,230
License revenues 2,271 2,442 9,836 3,852
---------- ----------- ---------- ----------
Total revenues 21,758 24,349 46,940 30,648
---------- ----------- ---------- ----------
Operating Expenses:
Research and development 8,779 13,824 44,426 49,450
General and administrative 4,558 4,093 17,268 15,092
---------- ----------- ---------- ----------
Total operating expenses 13,337 17,917 61,694 64,542
---------- ----------- ---------- ----------
Operating income (loss) 8,421 6,432 (14,754 ) (33,894 )
Interest and other, net 22 99 108 177
---------- ----------- ---------- ----------
Net income (loss) $ 8,443 $ 6,531 $ (14,646 ) $ (33,717 )
---------- ----------- ---------- ----------
Net income (loss) per share
- basic $ 0.23 $ 0.22 $ (0.41) $ (1.24)
Net income (loss) per share
- diluted $ 0.23 $ 0.21 $ (0.41) $ (1.24)
Weighted average shares
used in computing net
income (loss) per share -
basic 36,748 29,836 35,709 27,275
Weighted average shares
used in computing net
income (loss) per share -
diluted 36,786 31,190 35,709 27,275
Cytokinetics, Incorporated
Condensed Consolidated Balance Sheets
(in thousands)
December 31, December 31,
2014 2013((1))
-------------- --------------
(unaudited)
Assets
Cash and cash equivalents $ 20,215 $ 20,158
Short term investments 63,013 57,570
Related party accounts receivable 46,646 5
Other current assets 1,257 1,605
-------------- --------------
Total current assets 131,131 79,338
Property and equipment, net 1,637 1,221
Long-term investments - 2,502
Other assets 200 127
-------------- --------------
Total assets $ 132,968 $ 83,188
-------------- --------------
Liabilities and stockholders' equity
Deferred revenue, current $ 17,042 $ 14,701
Other current liabilities 6,813 12,003
-------------- --------------
Total current liabilities 23,855 26,704
Deferred revenue, non-current 16,558 1,500
Other non-current liabilities 491 542
Stockholders' equity 92,064 54,442
-------------- --------------
Total liabilities and stockholders' equity $ 132,968 $ 83,188
-------------- --------------
((1)) Derived from the audited financial statements, included in the Company's
Annual Report on Form 10-K for the year ended December 31, 2013.
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Cytokinetics, Inc. via GlobeNewswire
[HUG#1894244]
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Datum: 12.02.2015 - 22:00 Uhr
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