Hot Features
Premium
Register for Free to get streaming real-time quotes, interactive charts, live options flow, and more.
Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT) , a clinical stage biopharmaceutical company focused on the development and commercialization of novel bile acid therapeutics to treat chronic liver and intestinal diseases, has reported financial results for the fourth quarter and full year ended December 31, 2013 and provided an update on key development programs.
Summary of Key Programs, Updates and Anticipated Milestones
— PBC Program:
POISE top-line results expected in March 2014
Phase 3 confirmatory trial planned to be initiated in 3Q 2014
NDA and MAA Filings for OCA in PBC anticipated end of 2014
— FLINT Trial in NASH Stopped Early After Achieving Primary Efficacy Endpoint
Final results expected July 2014
Phase 3 program anticipated to begin in 1H 2015
Phase 2 DSP NASH trial enrollment completed; results anticipated 4Q 2015
Phase 2 lipid metabolism trial in NASH patients planned to be initiated in 2H 2014
— Proof of Concept Trial in Portal Hypertension (PESTO) Completed
Preliminary data indicate approximately 50% of patients had clinically meaningful reduction in HVPG
Additional data to be presented at EASL 2014
— Proof of Concept Trial in Bile Acid Diarrhea (OBADIAH) Completed; Data to be Presented at DDW 2014
— Double-Blind Phase 2 Trial Planned to be Initiated in Primary Sclerosing Cholangitis (PSC) in 2H 2014
— Phase 1 Trial for INT-767, Dual FXR and TGR5 Agonist, Planned to be Initiated in 4Q 2014
2013 Full-Year Financial Results
As of December 31, 2013, our cash, cash equivalents and investment securities available for sale totaled approximately $144.8 million, compared to $110.2 million at December 31, 2012. The net $34.6 million increase is primarily due to the net proceeds of $61.2 million from a public equity offering and $4.9 million received from exercise of warrants and options offset by $28.0 million in cash outflows from operations and $1.6 million expended in net additions to fixed assets. Based upon our currently expected level of program commitment and expected operating expenditures, we believe that we will be able to fund our operations into the third quarter of 2015.
Net loss attributable to common stockholders for the full year 2013 was $67.8 million, or $3.76 per share, compared to a net loss of $46.3 million, or $7.36 per share, for the full year 2012. The 2013 net loss includes $9.4 million in non-cash stock-based compensation expense, an increase of $6.1 million from 2012 and $28.4 million of non-cash warrant revaluation expense, an increase of $3.8 million from 2012. During 2013 the Company increased its expenditures in the OCA program by $6.0 million and increased its cash compensation expenses by $3.3 million, primarily due to an overall increase in the personnel base by 19 employees.
