Intercept Pharmaceuticals Reports Third Quarter 2015 Financial Results and Provides Business Update
Summary of Key Development Programs, Updates and Anticipated Milestones
- Nonalcoholic Steatohepatitis (NASH) Program
-- REGENERATE Phase 3 trial initiated
September 2015
-- CONTROL Phase 2 NASH statin trial initiation anticipated in 4Q 2015
- Primary Biliary Cirrhosis (recently renamed Primary Biliary Cholangitis [PBC]) Program
-- PDUFA Date
2/29/2016
-- COBALT Phase 3b confirmatory outcomes trial ongoing
- Primary Sclerosing Cholangitis (PSC) Program
-- AESOP Double-blind phase 2 trial enrolling
-- First clinical trial of OCA in this orphan indication with high unmet medical need
- Biliary Atresia Program
-- Phase 2 trial initiated
October 2015
- INT-767 Phase 1 Trial Initiation Anticipated by YE15
Financial Results
Nine Months Ended
For the nine months ended
Research and development (R&D) expenses increased to
General and administrative (G&A) expenses increased to
Intercept recorded a
Three Months Ended
Intercept reported a net loss of
Cash Position
As of
Intercept projects that adjusted operating expenses for the year ending
Intercept anticipates that stock-based compensation expense will represent the most significant non-cash item that is excluded in adjusted operating expenses as compared to operating expenses under U.S. generally accepted accounting principles, or GAAP. Adjusted operating expense is a financial measure not calculated in accordance with GAAP.
Conference Call on
Intercept will hold its 2015 third quarter financial results conference call and webcast on
About Intercept
Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat chronic underserved liver diseases. The Company's lead product candidate, obeticholic acid (OCA), is an agonist of the farnesoid X receptor (FXR). OCA is being developed for a variety of chronic liver diseases, including primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC) and biliary atresia. The
Non-GAAP Financial Measures
This press release presents projected adjusted operating expense, which is a non-GAAP measure and should be considered in addition to, but not as a substitute for, operating expense that Intercept prepares and announces in accordance with GAAP. Intercept excludes certain items from adjusted operating expense, such as stock-based compensation and other non-cash items, that management does not believe affect Intercept's basic operations and that do not meet the GAAP definition of unusual or non-recurring items. A reconciliation of projected non-GAAP adjusted operating expense to operating expense calculated in accordance with GAAP is not available on a forward-looking basis without unreasonable effort due to an inability to make accurate projections and estimates related to certain information needed to calculate, for example, future stock-based compensation expense. Management also uses adjusted operating expense to establish budgets and operational goals and to manage Intercept's business. Other companies may define this measure in different ways. Intercept believes this presentation provides investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information.
Safe Harbor Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding our financial position, including expected adjusted operating expenses, the activities anticipated to be undertaken by us, our ongoing and anticipated buildout and hiring to support our growing business operations and our strategic directives under the caption "About Intercept." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of important risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the initiation, cost, timing, progress and
results of our development activities, preclinical studies and clinical trials; the timing of and our ability to obtain and maintain regulatory approval of OCA, INT-767 and any other product candidates we may develop, particularly the possibility that regulatory authorities may require clinical outcomes data (and not just results based on achievement of a surrogate endpoint) as a condition to any marketing approval for OCA, and any related restrictions, limitations, and/or warnings in the label of any approved product candidates; our plans to research, develop and commercialize our product candidates; the election by our collaborators to pursue research, development and commercialization activities; our ability to attract collaborators with development, regulatory and commercialization expertise; our ability to obtain and maintain intellectual property protection for our product
candidates; our ability to successfully commercialize our product candidates; the size and growth of the markets for our product candidates and our ability to serve those markets; the rate and degree of market acceptance of any future products; the success of competing drugs that are or become available; regulatory developments in
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Condensed Consolidated Statements of Operations | ||||
(In thousands, except per share data) | ||||
Three Months Ended |
Nine Months Ended |
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2015 | 2014 | 2015 | 2014 | |
Licensing revenue | $ 445 | $ 445 | $ 2,336 | $ 1,296 |
Costs and expenses: | ||||
Research and development | 27,487 | 27,380 | 83,747 | 56,593 |
General and administrative | 24,742 | 9,136 | 58,854 | 22,742 |
Total operating expenses | $ 52,229 | $ 36,516 | $ 142,601 | $ 79,335 |
Other income (expense) | ||||
Revaluation of warrants | -- | -- | -- | (170,832) |
Other income (expense), net | 889 | 228 | 2,090 | 469 |
Net loss | $ (50,896) | $ (35,843) | $ (138,175) | $ (248,402) |
Net loss attributable to common stockholders | $ (50,896) | $ (35,843) | $ (138,175) | $ (248,402) |
Net loss per common share: | ||||
Basic | $ (2.10) | $ (1.69) | $ (5.89) | $ (12.07) |
Weighted average number of shares of common stock outstanding: | ||||
Basic | 24,214,913 | 21,260,303 | 23,472,026 | 20,583,146 |
Condensed Consolidated Balance Sheet Information | ||||
(In thousands) | ||||
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2015 | 2014 | |||
Cash, cash equivalents and investment securities | $ 695,708 | $ 272,806 | ||
Total assets | $ 716,747 | $ 286,021 | ||
Deferred revenue, total | $ 8,463 | $ 10,244 | ||
Total liabilities | $ 38,864 | $ 24,959 | ||
Stockholders' equity | $ 677,883 | $ 261,062 |
CONTACT: For more information aboutSource:Intercept Pharmaceuticals , please contact:Intercept Pharmaceuticals :Mark Vignola +1-646-747-1000 investors@interceptpharma.com Media inquiries: media@interceptpharma.com Investor inquiries: investors@interceptpharma.com
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