- 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.
- 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 $0.4 million related to an alternative minimum tax obligation for 2015.
A live webcast of Concert's presentation may be accessed in the Investors section of the Company's website at www.concertpharma.com. Please log on to the Concert website approximately 15 minutes prior to the scheduled webcast to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Concert's website for three months.- Financial Tables to Follow -
|Concert Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except per share amounts)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|License and research and development revenue||$||1,709||$||2,418||$||6,269||$||5,266|
|Research and development||7,135||8,569||22,499||20,406|
|General and administrative||3,268||3,457||9,800||8,713|
|Total operating expenses||10,403||12,026||32,299||29,119|
|(Loss) Income from operations||(8,694||)||(7,608||)||24,125||(21,853||)|
|Interest and other expense, net||(21||)||(224||)||(229||)||(919||)|
|(Loss) Income before income taxes||(8,715||)||(7,832||)||23,896||(22,772||)|
|(Benefit) Provision for income taxes||(161||)||—||406||—|
|Net (loss) income||$||(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||$||(1.52||)|
|Weighted-average number of common shares used in net (loss) income per share applicable to common stockholders—basic||21,949||18,098||20,824||15,046|
|Weighted-average number of common shares used in net (loss) income per share applicable to common stockholders— diluted||21,949||18,098||21,918||15,046|
|Concert Pharmaceuticals, Inc.|
|Summary Balance Sheet Data|
|September 30, 2015||December 31, 2014|
|Cash and cash equivalents||$||20,710||$||13,396|
|Investments, available for sale||121,270||65,836|
|Loan payable, net of discount||775||7,101|
|Total stockholders' equity||$||128,869||$||54,825|
Concert Pharmaceuticals Inc., the CoNCERT Pharmaceuticals Inc. logo and DCE Platform are registered trademarks of Concert Pharmaceuticals, Inc.