Concert Pharmaceuticals Reports Third Quarter 2017 Financial Results and Provides Company Update
Conference Call Scheduled Today at
"This is an exciting time for our deuterium-based chemistry as we
continue to demonstrate our technology's ability to meaningfully improve
the clinical properties of existing medicines. The CTP-656 program and
subsequent asset purchase agreement with Vertex Pharmaceuticals is a
great example of leveraging our platform to rapidly create significant
Recent Business Highlights and Upcoming Milestones
- CTP-543 Phase 2a Trial Underway. The Company began dosing patients in the Phase 2a trial in the third quarter of 2017. The Phase 2a trial is designed to assess two doses (4 mg and 8 mg twice daily) of CTP-543 compared to placebo in patients with moderate-to-severe alopecia areata over 24 weeks of dosing. Dosing in the 8 mg arm of the trial is expected to begin after an independent Data Monitoring Committee completes a planned interim review of the safety data from the first dosing cohort in the first quarter of 2018. Concert expects to complete the trial in the second half of 2018.
CTP-543 Patent Proceedings. In
October 2017, the Patent Trial and Appeal Board (PTAB) denied Incyte's petition to institute inter partes review (IPR) of U.S.Patent No. 9,249,149. The denial of Incyte's IPR petition upholds the validity of Concert's composition of matter patent claims covering CTP-543.
CTP-656 Asset Purchase Agreement Closed. In
July 2017, Concert received a $160 millioncash payment from Vertex Pharmaceuticals under an asset purchase agreement whereby Vertex acquired worldwide development and commercialization rights to CTP-656 and other assets related to the treatment of cystic fibrosis. CTP-656 is an investigational cystic fibrosis transmembrane conductance regulator (CFTR) potentiator that has the potential to be used as part of future once-daily combination regimens of CFTR modulators that treat the underlying cause of cystic fibrosis. Concert is eligible to receive up to $90 millionin additional milestones based on regulatory approval in the U.S.and reimbursement in the U.K., Germanyor France.
Alopecia Areata Patient Focused Drug Development Meeting. In
September 2017, the U.S. Food and Drug Administration(FDA) hosted a patient-focused meeting for alopecia areata as part of its Patient-Focused Drug Development Initiative. The meeting's goal was to obtain patient input on the impact of alopecia areata, including on daily life, patient views and experiences regarding current treatments, and decision factors taken into account when selecting a treatment. The meeting materials are available on the FDA's website at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm554443.htm
Repayment of Venture Debt. In
September 2017, Concert paid $30.8 millionto Hercules Capitalin repayment of the Company's outstanding obligations under a Loan Agreement. All outstanding obligations under the Loan Agreement were paid in full, and the agreement has been terminated.
Third Quarter 2017 Financial Results
Cash and Investments Position. Cash, cash equivalents and
investments as of
September 30, 2017, totaled $207.1 millionas compared to $103.4 millionas of June 30, 2017. Concert expects its cash, cash equivalents and investments as of September 30, 2017to be sufficient to fund the Company into 2021.
Revenues. Revenue was
$143.8 millionfor the quarter ended September 30, 2017, compared to $26,000for the corresponding quarter in 2016. The increase in revenue relates to the close of the CTP-656 asset purchase agreement with Vertex.
R&D Expenses. Research and development expenses were
$7.1 millionfor the quarter ended September 30, 2017, compared to $8.1 millionfor the same period in 2016, a decrease of $1.0 million. The decrease was primarily due to the discontinuation of development related to CTP-656 resulting from the asset purchase agreement.
G&A Expenses. General and administrative expenses were
$4.9 millionfor the quarter ended September 30, 2017, compared to $3.4 millionfor the same period in 2016, an increase of $1.5 million. The increase in general and administrative expenses was primarily related to an increase in stock compensation, professional and legal fees in connection with the CTP-656 asset purchase agreement and intellectual property matters related to CTP-543.
Net Income (Loss). For the quarter ended
September 30, 2017, net income was $128.1 million, or $5.61per share, as compared to a net loss of $11.4 million, or $0.51per share for the quarter ended September 30, 2016.
Conference Call and Webcast
The Company will host a conference call and webcast today at
A live webcast of Concert's presentation may be accessed in the Investors section of the Company's website at www.concertpharma.com. Please log on to the Concert website approximately 15 minutes prior to the scheduled webcast to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Concert's website for three months.
- Financial Tables to Follow -
|Condensed Consolidated Statements of Operations|
|(in thousands, except per share amounts)|
Three Months Ended
Nine Months Ended
|License and research and development revenue||$||17||$||26||$||52||$||153|
|Research and development||7,136||8,054||22,658||28,323|
|General and administrative||4,875||3,440||15,835||10,845|
|Total operating expenses||12,011||11,494||38,493||39,168|
|Income (loss) from operations||131,833||(11,468||)||105,386||(39,015||)|
|Interest and other income (expense), net||(1,591||)||112||(1,504||)||338|
|Income (loss) before tax provision||130,242||(11,356||)||103,882||(38,677||)|
|Provision for income taxes||2,177||—||2,177||—|
|Net income (loss)||$||128,065||$||(11,356||)||$||101,705||$||(38,677||)|
|Net income (loss) attributable to common stockholders - basic||127,324||(11,356||)||101,272||(38,677||)|
|Net income (loss) attributable to common stockholders - diluted||127,347||(11,356||)||101,284||(38,677||)|
|Net income (loss) per share applicable to common stockholders:|
Weighted-average number of common shares used in net
|Summary Balance Sheet Data|
|Cash and cash equivalents||$||32,119||$||40,555|
|Investments, available for sale||174,993||55,630|
|Total stockholders' equity||$||195,860||$||85,594|
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 CTP-543, the sufficiency of our
cash, cash equivalents and investments to fund our operations 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
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