Cytokinetics, Incorporated Reports Second Quarter 2013 Financial Results
(Thomson Reuters ONE) -
Company Provides Updated Financial and Milestone Guidance
in Connection with Recent Strategic Transactions and Clinical Trials Progress
SOUTH SAN FRANCISCO, CA, July 31, 2013 - Cytokinetics, Incorporated (Nasdaq:
CYTK) reported total research and development revenues for the second quarter of
2013 were $1.0 million, compared to $1.8 million during the same period in
2012. The second quarter revenue does not include $33.5 million in deferred
revenue related to the agreements entered into with Amgen Inc. and Astellas
Pharma Inc. in June 2013. The net loss for the second quarter was $15.0
million, or $0.58 per basic and diluted share. This is compared to a net loss
allocated to common stockholders for the same period in 2012, of $10.3 million,
or $0.76 per basic and diluted share, which included a one-time, non-cash
dividend of $1.3 million related to the beneficial conversion feature of the
Series B convertible preferred stock. As of June 30, 2013, cash, cash
equivalents and investments totaled $75.7 million, which includes the receipt of
$15 million from the expansion of our strategic collaboration with Amgen for
omecamtiv mecarbil and $10 million for the sale of common stock to Amgen, but
does not include $16.0 million received from Astellas in July 2013.
"In the second quarter, Cytokinetics announced important strategic transactions
and progress in our lead development-stage programs," stated Robert I. Blum,
Cytokinetics' President and Chief Executive Officer. "A new collaboration with
Astellas and an expanded alliance with Amgen afford us increased resources and
opportunities to take key steps forward as we are advancing multiple drug
candidates from our leading muscle biology directed research. We believe that
Cytokinetics is well-positioned in both our cardiac and skeletal muscle
activator programs to deliver on the promise they may represent for patients
suffering from grievous illnesses and we are looking forward to the results from
our Phase II clinical trials."
Updated Financial Guidance for 2013
Cytokinetics also announced its updated financial guidance for 2013. The
company anticipates cash revenue will be approximately $40 to $42 million, cash
R&D expenses will be in the range of $52 to $55 million, and cash G&A expenses
will be in the range of $15 to $16 million. This financial guidance is on a
cash basis and does not include the deferral of approximately $10 million in
revenue to future calendar years and an estimated $5.6 million in non-cash
related operating expenses primarily related to stock compensation expense.
Company Highlights
Cardiac Muscle Contractility
omecamtiv mecarbil
* During the quarter, Cytokinetics announced that results from ATOMIC-AHF
(Acute Treatment with Omecamtiv Mecarbil to Increase Contractility in Acute
Heart Failure) have been accepted for presentation during a Hot Line Late
Breaking Trials Session at the European Society of Cardiology (ESC)
Congress. ATOMIC-AHF is a Phase IIb clinical trial designed to evaluate the
safety, tolerability and efficacy of an intravenous formulation of omecamtiv
mecarbil compared to placebo in patients with left ventricular systolic
dysfunction who are hospitalized with acute heart failure.
* Recently, cohort 2 of COSMIC-HF (Chronic Oral Study of Myosin Activation to
Increase Contractility in Heart Failure) opened to enrollment. This Phase
II, double-blind, randomized, placebo-controlled, multicenter, dose
escalation study is designed to evaluate three modified-release oral
formulations of omecamtiv mecarbil in patients with heart failure and left
ventricular systolic dysfunction. COSMIC-HF is expected to inform the
selection of an oral formulation of omecamtiv mecarbil for potential
advancement into the Phase III clinical development program.
* During the quarter, Cytokinetics and Amgen reviewed results from a recently
completed Phase I, open-label, single-dose clinical trial designed to
compare the pharmacokinetics of omecamtiv mecarbil in patients undergoing
hemodialysis versus healthy volunteers. No clinically meaningful
differences were observed in this study in the pharmacokinetics of omecamtiv
mecarbil administered to patients undergoing hemodialysis versus healthy
volunteers.
The trials described above were or are being conducted by Amgen in collaboration
with Cytokinetics. Additional information on these and other clinical trials of
omecamtiv mecarbil can be found at www.clinicaltrials.gov.
Skeletal Muscle Contractility
tirasemtiv
* We are conducting BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects
and Functional Improvement with Tirasemtiv in ALS) at over 70 sites across
the United States, Canada and several European countries. To date, we have
enrolled over 500 patients in BENEFIT-ALS. Cytokinetics recently announced
that it had been informed by its data management vendor that a programming
error in the electronic data capture system controlling study drug
assignment for the on-going BENEFIT-ALS clinical trial caused 58 patients
initially randomized to and treated with tirasemtiv to receive placebo
instead at a certain study visit and for the remainder of the study. No
patients randomized to placebo were dispensed incorrect treatment.
Cytokinetics and all clinical trial personnel remain blinded to the specific
patients affected by the error. Following detection of the error, the
company took steps to ensure that no further incorrect study drug
assignments occurred and to correct the programming error in the electronic
data capture system controlling study drug assignment. In addition, we
convened an ad hoc meeting of the study's Data Safety Monitoring Board
(DSMB) to assess whether the error in dispensing study drug had impacted the
safety of the 58 affected patients. After review of the relevant safety
data from BENEFIT-ALS, the DSMB reported no concerns regarding patient
safety.
* Following interactions with regulatory authorities, Cytokinetics amended the
protocol for BENEFIT-ALS to enable increased enrollment to approximately
680 patients and to update the statistical methods section, in both cases
with the objective to maintain the originally intended statistical power of
the trial.
CK-2127107
* During the quarter, Cytokinetics continued to enroll patients in CY 5011, a
first-time-in-humans, Phase I clinical trial of CK-2127107, a novel small
molecule activator of the fast skeletal muscle troponin complex, in healthy
male volunteers. CY 5011 is a double-blind, randomized, placebo-controlled
study designed to assess the safety, tolerability, and pharmacokinetics of
single ascending oral doses of CK-2127107 administered in a three-period
crossover design.
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. In addition, the company continued
research activities directed to other muscle biology programs.
* In June, Cytokinetics announced the publication of three peer-reviewed
manuscripts co-authored by company scientists and a group led by Dr. Henk
Granzier, Professor of Physiology, and Norville Endowed Chair, Molecular
Cardiovascular Research Program, University of Arizona. These publications
describe translational research conducted by Dr. Granzier's laboratory in
collaboration with Cytokinetics in which the effects of fast skeletal muscle
troponin activation were explored in nemaline myopathy, a rare, sarcomere-
based disease.
Corporate
* In June, Cytokinetics announced an expansion of our strategic collaboration
with Amgen to include Japan. In consideration of this expansion,
Cytokinetics received $25 million from Amgen comprised of a $15 million non-
refundable license fee and $10 million for Amgen's purchase of 1.4 million
shares of Cytokinetics' common stock. Cytokinetics is also eligible to
receive additional pre-commercialization milestone payments for the
development of omecamtiv mecarbil in Japan of up to $50 million, as well as
royalties on sales of omecamtiv mecarbil in Japan. As of June 30, 2013,
the Company determined that all conditions necessary for revenue recognition
under the accounting guidelines had not been met. The Company will defer
the recognition of the $15.0 million license fee under this amendment to the
collaboration agreement until these criteria have been satisfied, which we
anticipate will be in the third quarter 2013.
* In June, Cytokinetics and Astellas Pharma Inc. announced a collaboration
focused on the research, development and commercialization of skeletal
muscle activators. The primary objective of the collaboration is to advance
novel therapies for diseases and medical conditions associated with muscle
weakness. The parties will jointly conduct research in the area of skeletal
muscle activation. Astellas will have exclusive rights to develop and
commercialize drug candidates that may arise from these activities, subject
to certain Cytokinetics' development and commercialization rights. As part
of this collaboration, Cytokinetics has exclusively licensed to Astellas the
rights to co-develop and commercialize CK-2127107, for potential
applications in non-neuromuscular indications. CK-2127107 will be developed
jointly by Cytokinetics and Astellas. Under the agreement, Cytokinetics
will be primarily responsible for the conduct of Phase I clinical trials and
certain Phase II readiness activities for CK-2127107 and Astellas will be
primarily responsible for the conduct of subsequent development and
commercialization activities for CK-2127107. Astellas will have exclusive
rights to develop and commercialize other fast skeletal troponin activators
in non-neuromuscular indications and to develop and commercialize other
novel mechanism skeletal muscle activators in all indications, subject to
certain Cytokinetics' development and commercialization rights. Astellas
will have the exclusive right to commercialize collaboration products
worldwide, subject to Cytokinetics' option to co-promote collaboration
products in the United States and Canada. In July, Cytokinetics received a
$16.0M non-refundable upfront payment and is eligible to potentially receive
over $24.0M in reimbursement of sponsored research and development
activities during the initial two years of the collaboration. In addition,
Cytokinetics is eligible to receive over $450 million in pre-
commercialization and commercialization milestones plus royalties. The
Company will recognize the $16.0 million upfront license fee ratably over
the 24 month period of the research plan with Astellas.
* In June, Cytokinetics filed a Certificate of Amendment to its Amended and
Restated Certificate of Incorporation to effect a one-for-six reverse stock
split of its common stock. As of June 30, 2013, there were 28,685,215 basic
shares outstanding and 41,495,272 fully diluted shares outstanding.
* In June, Cytokinetics was added as a member of the Russell Global, Russell
3000, Russell 2000 and Russell Microcap Indexes as Russell Investments
reconstituted its comprehensive family of global indexes.
Financials
Revenues for the second quarter of 2013 were $1.0 million, compared to $1.8
million during the same period in 2012. Revenues for the second quarter of
2013 included $0.4 million of revenue from our collaboration with MyoKardia,
Inc., $0.6 million of revenue from our collaboration with Amgen, and $36,000 of
grant revenue. Revenues for the same period in 2012 included $1.1 million of
revenue from our collaboration with Amgen, $0.3 million in grant revenue, and
$0.4 million of revenue from our collaboration with Global Blood Therapeutics,
Inc.
Total research and development (R&D) expenses in the second quarter of 2013 were
$12.3 million, compared with $8.2 million for the same period in 2012. The $4.1
million increase in R&D expenses for the second quarter of 2013, compared with
the same period in 2012, was primarily due to increased spending for outsourced
clinical and personnel-related costs, partially offset by decreased spending for
outsourced preclinical expenses.
Total general and administrative (G&A) expenses for the second quarter of 2013
were $3.7 million, compared with $2.6 million for the same period in 2012. The
$1.1 million increase in G&A expenses in the second quarter of 2013, compared
with the same period in 2012, was primarily due to increased spending for
personnel-related costs and legal expenses.
Revenues for the six months ended June 30, 2013 were $1.8 million, compared to
$3.7 million for the same period in 2012. Revenues for the first six months of
2013 included $0.9 million of reimbursements in program expenses under the Amgen
collaboration, $0.8 million revenue from our collaboration with MyoKardia and
$0.1 million of grant revenue. Revenues for the same period in 2012 included
$2.3 million of revenue from our collaboration with Amgen, $0.6 million in grant
revenue, and $0.8 million of revenue from our collaboration with Global Blood
Therapeutics.
Total R&D expenses for the six months ended June 30, 2013 were $22.2 million,
compared to $17.0 million for the same period in 2012. The $5.2 million increase
in R&D expenses in the first six months of 2013, over the same period in 2012,
was primarily due to increased spending for outsourced clinical and personnel-
related costs, partially offset by decreased spending for outsourced preclinical
expenses.
Total G&A expenses for the six months ended June 30, 2013 were $7.4 million,
compared to $5.6 million for the same period in 2012. The $1.8 million increase
in G&A spending in the first six months of 2013 compared to the same period in
2012, was primarily due to increased spending for personnel-related costs, legal
expenses and outside services.
The net loss allocable to common stockholders for the six months ended June
30, 2013, was $27.7 million, or $1.11 per basic and diluted share, compared to a
net loss allocable to common stockholders of $20.2 million, or $1.54 per basic
and diluted share, for the same period in 2012, which includes a one-time, non-
cash dividend of $1.3 million related to the beneficial conversion feature of
the Series B convertible preferred stock.
Company Milestones
Cardiac Muscle Contractility
omecamtiv mecarbil
* Results from ATOMIC-AHF are planned to be presented at the Hot Line Late
Breaking Clinical Trials Session at the ESC Congress in Amsterdam,
Netherlands on September 3, 2013 at 11:18 AM Central European Time. In
addition, results from ATOMIC-AHF are planned to be presented at the Late
Breaking Clinical Trial Session at the Heart Failure Society of America
Conference in Orlando, FL on September 23, 2013 at 4:00 PM Eastern Time.
* By the end of 2013, Cytokinetics expects the opening to enrollment of the
expansion phase of COSMIC-HF.
Skeletal Muscle Contractility
tirasemtiv
* In the second half of 2013, Cytokinetics anticipates completion of
enrollment in BENEFIT-ALS.
Conference Call and Webcast Information
Members of Cytokinetics' senior management team will review the company's second
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 92572524.
An archived replay of the webcast will be available via Cytokinetics' website
until August 7, 2013. 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 92572524 from July 31, 2013 at 5:30
PM Eastern Time until August 7, 2013.
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' lead drug candidate from its cardiac muscle
contractility program, omecamtiv mecarbil, is in Phase II clinical development
for the potential treatment of heart failure. Amgen Inc. holds an exclusive
license worldwide to develop and commercialize omecamtiv mecarbil and related
compounds, subject to Cytokinetics' specified development and commercialization
participation rights. Cytokinetics is independently developing tirasemtiv, a
fast skeletal muscle activator, as a potential treatment for diseases and
medical conditions associated with neuromuscular dysfunction. Tirasemtiv is
currently the subject of a Phase II clinical trials program and 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 amyotrophic lateral sclerosis, a
debilitating disease of neuromuscular impairment. Cytokinetics is collaborating
with Astellas Pharma Inc. to develop CK-2127107, a skeletal muscle activator
structurally distinct from tirasemtiv, for non-neuromuscular indications. 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
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' financial guidance, including expected
revenue and R&D and G&A expenses for 2013; Cytokinetics' and its partners'
research and development activities, including the initiation, conduct, design,
enrollment, progress, completion and results of clinical trials, the anticipated
timing for the availability of clinical trial results, planned presentations of
clinical trial results, and the significance and utility of clinical trial
results; the effectiveness of steps taken to prevent further occurrences of
incorrect study drug assignment; the objective of the protocol amendment for the
BENEFIT-ALS trial to maintain the originally intended statistical power of the
trial; potential milestone payments, royalties and other payments under
Cytokinetics' collaborations; the expected roles of Cytokinetics and Astellas
under their collaboration and in developing or commercializing drug candidates
or products subject to the collaboration; 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
may not be able to enroll additional patients in BENEFIT-ALS until the protocol
amendment is implemented; Cytokinetics anticipates that it will be required to
conduct at least one confirmatory Phase III clinical trial of tirasemtiv in ALS
patients which will require significant additional funding, and it may be unable
to obtain such additional funding 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, 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 Statements of Operations
(in thousands, except per share data)
(unaudited)
Three Months Ended Six Months Ended
June 30, June 30, June 30, June 30,
2013 2012 2013 2012
------------- ------------ ----------- ------------
Revenues:
Research and development $ 1,009 $ 1,841 $ 1 ,830 $ 3,661
------------- ---------- ----------- ----------
Total revenues 1,009 1,841 1,830 3,661
------------- ------------ ----------- ------------
Operating Expenses:
Research and development 12,347 8,242 22,181 16,987
General and administrative 3,730 2,568 7,364 5,624
Restructuring - (13) - (54)
------------- ------------ ----------- ------------
Total operating expenses 16,077 10,797 29,545 22,557
------------- ------------ ----------- ------------
Operating loss (15,068) (8,956) (27,715) (18,896)
Interest and other, net 27 13 55 26
------------- ------------ ----------- ------------
Net loss (15,041) (8,943) (27,660) (18,870)
Deemed dividend related to
beneficial conversion
feature of convertible
preferred stock - (1,307) - (1,307)
---------------------------------------------------
Net loss allocable to $
common stockholders $ (15,041) $ (10,250) $ (27,660) (20,177)
------------- ------------ ----------- ------------
Net loss per share
allocable to common
stockholders - basic and
diluted $ (0.58) $ (0.76) $ (1.11) $ (1.54)
Weighted average shares
used in computing net loss
per share allocable to
common stockholders - basic
and diluted 25,773 13,538 24,896 13,109
Cytokinetics, Incorporated
Condensed Balance Sheets
(in thousands)
(unaudited)
June 30, December 31,
2013 2012
----------------------------------
Assets
Cash and cash equivalents $ 17,057 $ 14,907
Short term investments 58,596 59,093
License fee receivable 16,000 -
Related party receivables - 4
Other current assets 1,967 2,423
------------ ---------------
Total current assets 93,620 76,427
Property and equipment, net 809 997
Other assets 126 127
------------ ---------------
Total assets $ 94,555 $ 77,551
------------ ---------------
Liabilities and stockholders' equity
Deferred revenue, current $ 25,529 $ -
Other current liabilities 8,517 7,105
------------ ---------------
Total current liabilities 34,046 7,105
Deferred revenue, non-current 8,000 -
Other non-current liabilities 520 361
Stockholders' equity 51,989 70,085
------------ ---------------
Total liabilities and stockholders' equity $ 94,555 $ 77,551
------------ ---------------
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters 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 Thomson Reuters ONE
[HUG#1720330]
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Datum: 31.07.2013 - 22:18 Uhr
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