Conference Call Scheduled Today at 8:30 a.m.
EST
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported
financial results for the third quarter of 2015.
“We have made progress with multiple drug candidates across our
diverse pipeline, in each case focusing on creating an improved
medicine by applying deuterium chemistry to meaningfully enhance
patient care,” said Roger Tung, PhD, Chief Executive Officer of
Concert Pharmaceuticals.
Dr. Tung continued, “In particular, we advanced the clinical
development of CTP-656 for the treatment of cystic fibrosis.
Recently, in a Phase 1 trial we demonstrated that CTP-656 has a
superior pharmacokinetic profile compared to current standard of
care, Kalydeco®, which supports the potential for once-daily
dosing. We look forward to rapidly developing CTP-656 as a new
treatment option that may provide a meaningful benefit to
individuals with cystic fibrosis.”
Recent Business Highlights and Upcoming Milestones
- AVP-786 Clinical Development. In
September 2015, Avanir Pharmaceuticals began recruiting patients in
a Phase 2 trial evaluating AVP-786 as an adjunctive treatment for
patients with residual schizophrenia. In addition, Concert
continues to expect Avanir to advance AVP-786 into Phase 3 clinical
trials for the treatment of agitation in patients with dementia of
the Alzheimer’s type. The Phase 3 trials are expected to begin in
the fourth quarter of 2015.
- CTP-656 Phase 1 Results for Cystic
Fibrosis. In September and October 2015, Concert presented
CTP-656 Phase 1 single ascending dose clinical trial results.
CTP-656 demonstrated a superior pharmacokinetic profile compared to
Kalydeco, and the trial results support once-daily dosing. Results
of the Phase 1 trial also showed that CTP-656 was well-tolerated
and its safety profile was comparable to Kalydeco. The findings
were presented at the Cystic Fibrosis UK Trust Conference and the
North American Cystic Fibrosis Conference. Concert expects to
initiate a multiple ascending dose Phase 1 trial of CTP-656 in
healthy volunteers in the fourth quarter of 2015.
- Development Milestone under Celgene
Collaboration. Under its collaboration with Celgene, Concert
achieved an $8 million milestone in October 2015 based on the
completion of the CTP-730 (deuterated apremilast) Phase 1
studies.
- CTP-499 Special Protocol Assessment
Agreement. Concert has reached agreement with the U.S. Food and
Drug Administration (FDA) under a Special Protocol Assessment (SPA)
for a Phase 3 clinical trial of CTP-499 for the treatment of
diabetic nephropathy. The SPA is a written agreement with the FDA
on the design, endpoints and statistical analysis of a Phase 3
trial to support a New Drug Application (NDA). The Company intends
to seek one or more collaborators for future development.
Third Quarter 2015 Financial Results
- Cash and Investment Position.
Cash, cash equivalents and investments as of September 30, 2015,
totaled $142.0 million as compared to $151.7 million as of June 30,
2015. In October 2015, the Company achieved an $8 million milestone
under its collaboration with Celgene and expects to receive payment
in the fourth quarter.
- Revenues. Revenue was $1.7
million for the quarter ended September 30, 2015, compared to $4.4
million for the corresponding quarter in 2014. The decrease in
revenue was partially due to the completion of the Phase 1 study
with Jazz Pharmaceuticals in the first half of 2015. In addition,
we achieved a $2.0 million development milestone from Avanir
Pharmaceuticals recognized in the third quarter of 2014 for
commencement of a Phase 2 clinical trial of AVP-786 in major
depressive disorder.
- R&D Expenses. Research and
development expenses were $7.1 million for the quarter ended
September 30, 2015, compared to $8.6 million for the same period in
2014, a decrease of $1.5 million. The decrease in research and
development expenses was primarily attributable to decreased
expenses associated with JZP-386 and other proprietary programs,
partially offset by increased development expenses associated with
CTP-656.
- G&A Expenses. General and
administrative expenses were $3.3 million for the quarter ended
September 30, 2015, compared to $3.5 million for the same period in
2014, a decrease of $0.2 million.
- Net Income (Loss). For the
quarter ended September 30, 2015, net loss was $8.6 million, or
$0.39 per share, as compared to a net loss of $7.8 million, or
$0.43 per share, for the quarter ended September 30, 2014. As a
result of a $50 million payment from Auspex Pharmaceuticals in June
2015, the Company expects to be profitable for the full year.
Concert expects to have sufficient operating loss carryforwards
available to offset its estimated ordinary taxable income for
fiscal 2015. During the nine months ended September 30, 2015,
Concert has recorded a tax provision of $0.4 million related to an
alternative minimum tax obligation for 2015.
Conference Call and Webcast
The Company will host a conference call and webcast today at
8:30 a.m. EST to provide an update on the company and discuss third
quarter financial results. To access the conference call, please
dial (855) 354-1855 (U.S. and Canada) or (484) 365-2865
(International) five minutes prior to the start time.
A live webcast of Concert’s presentation may be accessed in the
Investors section of the Company’s website at
www.concertpharma.com. Please log on to the Concert website
approximately 15 minutes prior to the scheduled webcast to ensure
adequate time for any software downloads that may be required. A
replay of the webcast will be available on Concert’s website for
three months.
- Financial Tables to Follow -
Concert Pharmaceuticals, Inc. Condensed
Consolidated Statements of Operations (in thousands, except
per share amounts)
Three Months Ended September
30,
Nine Months Ended September 30, 2015
2014 2015 2014 Revenue: License and
research and development revenue $ 1,709 $ 2,418 $ 6,269 $ 5,266
Other revenue — — 50,155 — Milestone revenue — 2,000
— 2,000 Total revenue 1,709 4,418
56,424 7,266 Operating expenses: Research and
development 7,135 8,569 22,499 20,406 General and administrative
3,268 3,457 9,800 8,713 Total operating
expenses 10,403 12,026 32,299 29,119
(Loss) Income from operations (8,694 ) (7,608 ) 24,125 (21,853 )
Interest and other expense, net (21 ) (224 ) (229 ) (919 ) (Loss)
Income before income taxes (8,715 ) (7,832 ) 23,896 (22,772 )
(Benefit) Provision for income taxes (161 ) — 406 —
Net (loss) income $ (8,554 ) $ (7,832 ) $ 23,490 $
(22,772 ) Accretion on redeemable convertible preferred
stock — — — (55 ) Net (loss) income
applicable to common stockholders $ (8,554 ) $ (7,832 ) $ 23,490
$ (22,827 ) Net (loss) income per share applicable to
common stockholders—basic $ (0.39 ) $ (0.43 ) $ 1.13 $ (1.52
) Net (loss) income per share applicable to common
stockholders—diluted $ (0.39 ) $ (0.43 ) $ 1.07 $ (1.52 )
Weighted-average number of common shares used in net (loss)
income per share applicable to common stockholders—basic 21,949
18,098 20,824 15,046 Weighted-average number of common
shares used in net (loss) income per share applicable to common
stockholders— diluted 21,949 18,098 21,918 15,046
Concert Pharmaceuticals, Inc. Summary Balance Sheet
Data (in thousands) September 30,
2015 December 31, 2014 Cash and cash equivalents
$ 20,710 $ 13,396 Investments, available for sale 121,270 65,836
Working capital 135,738 63,102 Total assets 146,254 84,454 Deferred
revenue 10,341 15,821 Loan payable, net of discount 775 7,101 Total
stockholders’ equity $ 128,869 $ 54,825
About Concert
Concert Pharmaceuticals is a clinical stage biopharmaceutical
company focused on applying its DCE Platform® (deuterated chemical
entity platform) to create novel small molecule drugs. This
approach starts with approved drugs, advanced clinical candidates
or previously studied compounds that have the potential to be
improved with deuterium substitution to enhance clinical safety,
tolerability and efficacy. The Company is developing a broad
pipeline targeting CNS disorders, genetic diseases, renal disease,
inflammatory diseases and cancer. For more information, please
visit www.concertpharma.com.
Cautionary Note on Forward Looking Statements
Any statements in this press release about our future
expectations, plans and prospects, including statements about our
expectations on the progress of clinical development of our
therapeutic candidates, including CTP-656, and other statements
containing the words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “would,” and similar
expressions, constitute forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including: the uncertainties inherent in the initiation of
future clinical trials, whether preliminary results from a clinical
trial will be predictive of the final results of that trial or
whether results of early clinical trials will be indicative of the
results of later clinical trials, expectations for regulatory
approvals, availability of funding sufficient for our foreseeable
and unforeseeable operating expenses and capital expenditure
requirements and other factors discussed in the “Risk Factors”
section of our most recent Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission and in other filings that we
make with the Securities and Exchange Commission. In addition, any
forward-looking statements included in this press release represent
our views only as of the date of this release and should not be
relied upon as representing our views as of any subsequent date. We
specifically disclaim any obligation to update any forward-looking
statements included in this press release.
Concert Pharmaceuticals Inc., the CoNCERT
Pharmaceuticals Inc. logo and DCE Platform are registered
trademarks of Concert Pharmaceuticals, Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20151105005305/en/
Concert Pharmaceuticals, Inc.Justine Koenigsberg (investors),
781-674-5284ir@concertpharma.comorThe Yates NetworkKathryn Morris
(media), 845-635-9828
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