[February 27, 2015] |
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Concert Pharmaceuticals Reports Year End 2014 Financial Results
Concert
Pharmaceuticals, Inc. (NASDAQ: CNCE) today reported financial
results for the year ended December 31, 2014 and provided an update on
its product pipeline and corporate activities.
"We made significant progress in 2014 in a number of areas, including
important advances in our clinical programs. Our deuterium chemistry
platform continues to be highly productive, providing us with excellent
opportunities to expand our pipeline of product candidates, as evidenced
by deuterium-modified ivacaftor, our new clinical candidate for cystic
fibrosis," stated Roger Tung, Ph.D., President and Chief Executive
Officer of Concert Pharmaceuticals. "In 2015, we expect continued
clinical progression across our pipeline, including the potential
advancement of AVP-786 into pivotal testing this year."
Recent Business Highlights and Upcoming Milestones
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Highlighted broad clinical potential of AVP-786 under
collaboration with Avanir Pharmaceuticals. Avanir
Pharmaceuticals intends to meet with the U.S. Food and Drug
Administration in early 2015 to discuss the potential advancement of
AVP-786 into Phase 3 clinical testing for the treatment of agitation
in patients with Alzheimer's Disease. In addition, Avanir is
conducting a Phase 2 clinical trial evaluating AVP-786 for the
treatment of major depressive disorder.
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Announced new clinical candidate for cystic fibrosis.
Concert has selected deuterium-modified ivacaftor for the treatment of
the genetic disease cystic fibrosis as the next clinical candidate.
Deuterated ivacaftor, a novel potentiator of the cystic fibrosis
transmembrane conductance regulator (CFTR), has the potential to be a
disease-modifying agent for patients with cystic fibrosis alone and in
combination with other CFTR modulators. Concert plans to initiate
clinical testing in the first half of 2015.
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Commenced SPA process for CTP-499, a potential treatment for
diabetic nephropathy. Concert initiated its process to
negotiate a Special Protocol Assessment (SPA) for CTP-499 with the
FDA. Concert expects to complete the SPA process in 2015.
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Commenced Phase 1 trial for JZP-386 under Jazz Pharmaceuticals
collaboration. The Phase 1 clinical trial evaluating JZP-386
is underway and data that will inform the next steps in the
development of JZP-386 is expected in the second quarter of 2015.
Concert and Jazz Pharmaceuticals are collaborating on the development
of JZP-386 as a next-generation agent for the treatment of narcolepsy.
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Advanced Phase 1 program for CTP-730 under Celgene
collaboration. In the third quarter of 2014, Concert initiated
Phase 1 testing of CTP-730 for inflammatory disease. The Phase 1
program will encompass single and multiple ascending dose trials. In
2015, Concert expects to complete Phase 1 clinical testing of CTP-730
and has the potential to realize its first development milestone
payment under its collaboration with Celgene.
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Began additional non-clinical assessment of CTP-354, a potential
treatment for spasticity. In January 2015, Concert received
study reports confirming that the adverse effects seen in the three
month non-clinical studies were limited to one of the two species
studied. Concert intends to conduct additional non-clinical evaluation
in 2015 before commencing further clinical development of CTP-354.
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Broadened Patent Estate. During the fourth
quarter of 2014, the U.S. Patent and Trademark Office awarded Concert
four new patents. As of December 31, 2014, Concert held 63 issued
patents in the United States, including composition of matter patents
for each of Concert's development programs.
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Expanded Executive Management Team and Board of
Directors. In February 2015, Concert appointed James Cassella,
Ph.D. as its Chief Development Officer. Dr. Cassella has more than 25
years of experience in pharmaceutical drug development including
clinical trial design and execution, regulatory affairs and product
registration. In December 2014, Concert appointed Thomas G.
Auchincloss, Jr. to its Board of Directors and as the independent
Chair of its Audit Committee. Mr. Auchincloss is a financial expert
and seasoned corporate financial executive with more than 30 years of
financial experience.
Full Year 2014 Financial Results
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Cash and Investment Position: Cash, cash equivalents and
investments as of December 31, 2014, totaled $79.2 million as compared
to $32.7 million as of December 31, 2013. In the first quarter of
2014, Concert completed its initial public offering, raising net
proceeds of $83.1 million. Concert expects its cash, cash equivalents
and investments as of December 31, 2014 are sufficient to fund the
company into the second half of 2016.
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Revenues: Revenue was $8.6 million for the year ended December
31, 2014, compared to $25.4 million for the year ended December 31,
2013. In 2013, Concert recognized $17.0 million of license revenue
under its collaboration agreement with Celgene Corporation and $3.7
million of license revenue under its licensing agreement with Jazz
Pharmaceuticals. Revenue recognized in 2014 is comprised of services
performed by Concert in connection with its strategic collaborations
and a $2.0 million milestone payment from Avanir Pharmaceuticals based
on the initiation of a Phase 2 clinical trial of AVP-786 in major
depressive disorder.
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R&D Expenses: Research and development expenses were $27.5
million for the year ended December 31, 2014, compared to $21.8
million for the same period in 2013, an increase of $5.7 million. The
increase was primarily due to expenses associated with the development
of CTP-354, JZP-386 and CTP-730.
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G&A Expenses: General and administrative expenses were
$11.7 million for the year ended December 31, 2014, compared to $8.0
million for the same period in 2013. The increase in general and
administrative expenses was primarily related to cash compensation and
non-cash stock based compensation expenses and expenses associated
with operating as a public company.
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Net Loss: For the year ended December 31, 2014, net loss
applicable to common stockholders was $31.8 million, or $2.00 per
share, compared with a net loss applicable to common stockholders of
$6.5 million, or $4.99 per share, for the year ended December 31, 2013.
Conference Call and Webcast
The company will host a conference call and webcast today at 8:30 a.m.
ET to provide an update on the company and discuss full year 2014
financial results. To access the conference call, please dial (855)
354-1855 (U.S. and Canada) or (484) 365-2865 (International) five
minutes prior to the start time.
A live webcast may be accessed in the Investors section of the company's
website at www.concertpharma.com.
Please log on to the Concert website approximately 15 minutes prior to
the scheduled webcast to ensure adequate time for any software downloads
that may be required. A replay of the webcast will be available on
Concert's website for three months.
- Financial Tables to Follow -
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Concert Pharmaceuticals, Inc.
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Condensed Consolidated Statements of Operations
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(in thousands, except per share amounts)
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Year ended December 31,
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2014
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2013
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Revenue:
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License and research and development revenue
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$
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6,576
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$
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23,408
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Milestone revenue
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2,000
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2,000
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Total revenue
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8,576
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25,408
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Operating expenses:
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Research and development
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27,474
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21,790
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General and administrative
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11,700
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8,028
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Total operating expenses
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39,174
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29,818
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Loss from operations
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(30,598
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(4,410
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Interest and other expense, net
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(1,101
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(1,646
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Net loss
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$
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(31,699
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$
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(6,056
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Accretion on redeemable convertible preferred stock
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(55
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(396
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Net loss applicable to common stockholders
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$
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(31,754
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$
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(6,452
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Net loss per share applicable to common stockholders-basic and
diluted
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$
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(2.00
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$
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(4.99
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Weighted-average number of common shares used in net loss per share applicable
to common stockholders-basic and diluted
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15,842
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1,292
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Concert Pharmaceuticals, Inc.
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Summary Balance Sheet Data
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(in thousands)
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December 31,
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2014
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2013
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Cash and cash equivalents
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$
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13,396
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$
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9,638
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Investments, available for sale
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65,836
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23,039
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Working capital
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63,102
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18,128
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Total assets
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84,454
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39,773
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Deferred revenue
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15,821
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19,631
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Loan payable, net of discount
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7,101
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14,919
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Redeemable convertible preferred stock
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-
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112,244
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Total stockholders' equity (deficit)
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$
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54,825
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$
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(112,104
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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 clinical development of
our therapeutic candidates, potential achievement of milestone payments
and expectations regarding the sufficiency of our cash balance to fund
operating expenses and capital expenditures, 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, availability and
timing of data from ongoing and future clinical trials and the results
of such 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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