Conference Call Scheduled Today at 8:30 a.m.
EDT
Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported
financial results for the second quarter of 2016.
“Concert has made significant progress with our pipeline of
multiple products, including CTP-656 and CTP-543, both of which we
are committed to advancing into efficacy trials in 2017. CTP-656
for cystic fibrosis has demonstrated properties that we believe
will be beneficial over the current standard of care. CTP-543 for
alopecia areata is following a similar approach of building on the
known activity of approved drugs to provide a novel and
differentiated treatment for patients,” said Roger Tung, Ph.D.,
President and Chief Executive Officer of Concert Pharmaceuticals,
Inc. “These drug candidates demonstrate the ability of our DCE
Platform® to readily bring new drug candidates into development
with the potential to improve patient care, whether competing with
the non-deuterated drug in an existing market or meeting an unmet
need in a new market.”
Recent Business Highlights and Upcoming Milestones
- CTP-656 Phase 1 Results Presented at
European Cystic Fibrosis Conference. In June 2016, Concert
presented results from a Phase 1 multiple ascending dose trial
of CTP-656 at the European Cystic Fibrosis Society Conference.
The Phase 1 results support the development of CTP-656 as a
once-daily treatment for cystic fibrosis. These results also
demonstrated that the pharmacokinetic profile of CTP-656 was
superior to that of Kalydeco®, the current standard of care for
cystic fibrosis caused by certain CFTR mutations. Concert plans to
conduct a Phase 2 clinical trial with CTP-656 in cystic fibrosis
patients with these mutations. The Company expects to open an
Investigational New Drug application (IND) in the fourth quarter of
2016 to support the Phase 2 trial. Topline results from
the Phase 2 trial are expected in the second half of 2017.
- CTP-543 Phase 1 for Alopecia
Areata. In May 2016, Concert unveiled its next clinical
candidate, CTP-543, for the oral treatment of alopecia areata, an
autoimmune disease for which there are currently no approved
treatments. CTP-543 is a deuterium-modified analog of ruxolitinib,
which selectively inhibits Janus kinases JAK1 and JAK2. The Phase 1
clinical program for CTP-543 in healthy volunteers, which includes
single and multiple ascending dose trials, was initiated in the
second quarter of 2016 and topline Phase 1 data is expected in the
fourth quarter of 2016. A Phase 2 trial in patients with alopecia
areata is expected to begin in the first half of 2017.
Second Quarter 2016 Financial Results
- Cash and Investment Position.
Cash, cash equivalents and investments as of June 30, 2016, totaled
$118.4 million as compared to $127.7 million as of March 31, 2016.
Concert expects its cash, cash equivalents and investments as of
June 30, 2016 to be sufficient to fund the Company into 2018.
- Revenues. Revenue was $71,000
for the quarter ended June 30, 2016, compared to $53.4 million for
the corresponding quarter in 2015. The decrease in revenue was
related to a one-time payment of $50.2 million received in the
second quarter of 2015 as a result of a patent assignment agreement
between Concert and Auspex Pharmaceuticals, Inc. Under the
agreement, Concert became eligible to receive the payment due to a
change of control of Auspex, which was acquired by Teva
Pharmaceuticals Industries Ltd. in May 2015. The decrease in
revenue also relates to the completion of the Phase 1 clinical
evaluation under our strategic collaboration with Celgene
Corporation in 2015.
- R&D Expenses. Research and
development expenses were $9.8 million for the quarter ended June
30, 2016, compared to $8.4 million for the same period in 2015, an
increase of $1.4 million. The increase was primarily due to
expenses associated with the development of the Company’s
proprietary programs CTP-656 and CTP-543.
- G&A Expenses. General and
administrative expenses were $3.8 million for the quarter ended
June 30, 2016, compared to $3.3 million for the same period in
2015, an increase of $0.5 million. The increase in general and
administrative expenses was primarily related to non-cash
stock-based compensation.
- Net Loss. For the quarter ended
June 30, 2016, net loss was $13.4 million, or $0.60 per share, as
compared to a net income of $41.0 million, or $1.89 per share –
basic and $1.80 per share – diluted, for the quarter ended June 30,
2015. Profitability in the second quarter of 2015 was the result of
the Auspex change in control payment.
Conference Call and Webcast
The Company will host a conference call and webcast today at
8:30 a.m. EDT to provide an update on the company and discuss
second 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 endedJune
30,
Six months endedJune 30,
2016 2015 2016
2015 Revenue: License and research and development revenue $
71 $ 3,254 $ 127 $ 4,560 Other revenue — 50,155
— 50,155 Total revenue 71 53,409
127 54,715 Operating expenses: Research and development
9,816 8,420 20,269 15,364 General and administrative 3,828
3,299 7,405 6,532 Total operating expenses
13,644 11,719 27,674 21,896 (Loss)
Income from operations (13,573 ) 41,690 (27,547 ) 32,819 Interest
and other income (expense), net 132 (77 ) 226
(208 ) (Loss) Income before income taxes (13,441 ) 41,613
(27,321 ) 32,611 Provision for income taxes — 567
— 567 Net (loss) income $ (13,441 ) $ 41,046 $
(27,321 ) $ 32,044 Net (loss) income per share applicable to common
stockholders—basic $ (0.60 ) $ 1.89 $ (1.23 ) $ 1.58 Net (loss)
income per share applicable to common stockholders—diluted $ (0.60
) $ 1.80 $ (1.23 ) $ 1.50 Weighted-average number of common shares
used in net (loss) income per share applicable to common
stockholders—basic 22,217 21,762 22,208
20,252 Weighted-average number of common shares used in net (loss)
income per share applicable to common stockholders— diluted
22,217 22,850 22,208 21,355
Concert
Pharmaceuticals, Inc. Summary Balance Sheet Data (in
thousands) June 30,
December 31, 2016 2015 Cash and cash
equivalents $ 53,651 $ 92,510 Investments, available for sale
64,769 49,680 Working capital 113,076 137,481 Total assets 122,631
146,932 Deferred revenue 10,088 10,170 Total stockholders’ equity $
106,183 $ 130,635
- more -
About Concert
Concert Pharmaceuticals is a clinical stage biopharmaceutical
company focused on applying its DCE Platform® (deuterated chemical
entity platform) to create novel medicines designed to address
unmet patient needs. The Company’s approach starts with approved
drugs in which deuterium substitution has the potential to enhance
clinical safety, tolerability or efficacy. Concert has a broad
pipeline of innovative medicines targeting pulmonary diseases,
including cystic fibrosis, central nervous systems (CNS) disorders,
as well as autoimmune and inflammatory diseases. 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 for clinical development of our therapeutic
candidates, including CTP-656 and CTP-543, 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.
Kalydeco is a registered trademark of Vertex
Pharmaceuticals, Inc.
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version on businesswire.com: http://www.businesswire.com/news/home/20160809005124/en/
Concert Pharmaceuticals, Inc.Justine Koenigsberg (investors),
781-674-5284ir@concertpharma.comorThe Yates NetworkKathryn Morris
(media), 845-635-9828
Concert Pharmaceuticals (NASDAQ:CNCE)
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