ICPT Intercept Pharmaceuticals Inc.

41.9
-1.72  -4%
Previous Close 43.62
Open 43.97
52 Week Low 40.3
52 Week High 125
Market Cap $1,381,895,688
Shares 32,980,804
Float 20,800,490
Enterprise Value $1,406,278,687
Volume 1,258,878
Av. Daily Volume 764,648
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Drug Pipeline

Drug Stage Notes
Ocaliva (Obeticholic acid (OCA)) - REGENERATE
Adult nonalcoholic steatohepatitis (NASH) patients.
Phase 3
Phase 3
CRL announced June 29, 2020.
Ocaliva - Obeticholic acid (OCA) - REVERSE
NASH patients with compensated cirrhosis
Phase 3
Phase 3
Phase 3 completion of enrolment announced January 29, 2020.
Obeticholic acid (Ocaliva)
Primary biliary cirrhosis (PBC) - POISE
Approved
Approved
Approved May 27 2016. Updated U.S. label for Ocaliva anticipated by early 2018
Obeticholic acid (OCA) AESOP
Primary Sclerosing Cholangitis (PSC)
Phase 2
Phase 2
Phase 2 data released July 31, 2017 - primary endpoint met. Late breaker at AASLD October 23, 2017.
Obeticholic acid (OCA) - CONTROL
NASH patients taking statins
Phase 2
Phase 2
Phase 2 primary endpoint met - July 31, 2017. One patient death noted but DSMB noted unlikely to be related to OCA (company unsure).

Latest News

  1. NEW YORK, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that Mark Pruzanski, M.D., President and Chief Executive Officer and Sandip Kapadia, Chief Financial Officer of Intercept, will present at the Wells Fargo 2020 Virtual Healthcare Conference on Wednesday, September 9, 2020 at 12:00 p.m. ET.

    A live webcast of the event will be available on the investor page of Intercept's website at http://ir.interceptpharma.com. An audio archive of the webcast will also be available on Intercept's website for approximately two weeks.

    The company will also…

    NEW YORK, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that Mark Pruzanski, M.D., President and Chief Executive Officer and Sandip Kapadia, Chief Financial Officer of Intercept, will present at the Wells Fargo 2020 Virtual Healthcare Conference on Wednesday, September 9, 2020 at 12:00 p.m. ET.

    A live webcast of the event will be available on the investor page of Intercept's website at http://ir.interceptpharma.com. An audio archive of the webcast will also be available on Intercept's website for approximately two weeks.

    The company will also host meetings at Baird's 2020 Global Healthcare Conference on September 9, 2020 and Citi's Annual BioPharma Virtual Conference on September 10, 2020.

    About Intercept

    Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Founded in 2002 in New York, Intercept has operations in the United States, Europe and Canada. For more information, please visit www.interceptpharma.com or connect with the company on Twitter and LinkedIn.

    CONTACT

    For more information about Intercept, please contact:

    Investor inquiries: 

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  2. NEW YORK, Aug. 27, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced additional data indicating that obeticholic acid (OCA) helped patients with nonalcoholic steatohepatitis (NASH) achieve sustained improvements in liver biochemistry and noninvasive markers of liver fibrosis over two years of treatment. The new results based upon a post hoc review of the interim analysis data from the Phase 3 REGENERATE study are being presented at the virtual International Liver Congress™ 2020, the 55th Annual Meeting of the European Association for the Study of the Liver (EASL…

    NEW YORK, Aug. 27, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced additional data indicating that obeticholic acid (OCA) helped patients with nonalcoholic steatohepatitis (NASH) achieve sustained improvements in liver biochemistry and noninvasive markers of liver fibrosis over two years of treatment. The new results based upon a post hoc review of the interim analysis data from the Phase 3 REGENERATE study are being presented at the virtual International Liver Congress™ 2020, the 55th Annual Meeting of the European Association for the Study of the Liver (EASL).

    "The primary goal of a medicine to treat patients with advanced fibrosis due to NASH is to halt or reverse the progression to cirrhosis and its devastating complications," said Rohit Loomba, M.D., director, U.C. San Diego NAFLD Research Center and director of hepatology at U.C. San Diego School of Medicine. "These new noninvasive data from REGENERATE provide further evidence that OCA can help patients achieve this goal. It is encouraging to see a consistent and sustained effect across multiple noninvasive tests that clinicians use in practice every day to monitor and manage their patients. The marked improvement in measurements of liver stiffness observed with OCA therapy was particularly notable. Additionally, these data give us greater confidence that OCA continues to provide meaningful and durable benefit beyond the histologic benefit already established at 18 months."

    As previously reported, once-daily OCA 25 mg met the primary endpoint of fibrosis improvement (≥1 stage) with no worsening of NASH at the planned 18-month interim analysis of REGENERATE with high statistical significance (p=0.0002 vs. placebo). The new analysis included patients from the interim analysis intent-to-treat (ITT) population randomized early enough to have both evaluable Month 18 biopsies (N = 251–263 per treatment arm) and Month 24 data at the time of the interim analysis (N = 120–125 per arm). Changes from baseline to Month 24 in alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), serum markers of fibrosis (FIB-4, AST to platelet ratio index [APRI]), and liver stiffness (FibroScan® vibration-controlled transient elastography [VCTE]; subset, N = 64‒70 per arm) were analyzed.

    Mean values of transaminases and other serum-based tests improved rapidly in patients treated with OCA and were sustained beyond 18 months of therapy compared with placebo. FibroScan VCTE also demonstrated improvement in liver stiffness in patients treated with OCA versus placebo after 24 months of therapy, with a mean difference of 2.7 kPa between OCA 25 mg and placebo. At baseline, median liver stiffness values were in the advanced fibrosis range; at 24 months, median values of patients treated with OCA 25 mg were below the threshold of 7.9 kPa, and most patients treated with OCA 25 mg had moved from advanced to moderate fibrosis.

    Changes in transaminases and noninvasive markers of fibrosis were associated with changes in histologic fibrosis, with the greatest improvements observed in patients who had a ≥1 stage improvement in fibrosis stage at 18 months. Moreover, early changes in these markers were more pronounced in patients who had histologic fibrosis improvement at Month 18. Overall, these noninvasive data suggest that longer treatment duration with OCA will likely result in greater fibrosis reduction beyond 18 months.

    The overall adverse event profile of OCA 25 mg in the subgroup of the ITT population with 24 months of follow-up at the time of the interim analysis was generally consistent with that observed in the overall ITT population. The most common adverse event was pruritus. The incidence of serious adverse events was balanced across the placebo and OCA 25 mg groups. Few serious adverse events occurred in more than one patient and no consistent pattern of serious adverse events was observed.

    About Liver Fibrosis due to NASH

    Nonalcoholic steatohepatitis (NASH) is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death. Advanced fibrosis is associated with a substantially higher risk of liver-related morbidity and mortality in patients with NASH. In the United States, NASH is currently the second leading cause for liver transplantation overall, and in females, the leading cause. NASH is anticipated to become the leading indication for liver transplantation in Europe within the next decade. There are currently no medications approved for the treatment of NASH.

    About the REGENERATE Study

    REGENERATE is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study assessing the safety and efficacy of obeticholic acid (OCA) on clinical outcomes in patients with liver fibrosis due to NASH. A pre-specified 18-month analysis was conducted to assess the effect of OCA on liver histology comparing month 18 biopsies with baseline. REGENERATE has completed target enrollment for the clinical outcomes cohort, with 2,480 adult NASH patients randomized at over 300 qualified centers worldwide, and is expected to continue through clinical outcomes for verification and description of clinical benefit. The end-of-study analysis is designed to evaluate the effect of OCA on all-cause mortality and liver-related clinical outcomes, as well as long-term safety.

    About Intercept

    Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Founded in 2002 in New York, Intercept has operations in the United States, Europe and Canada. For more information, please visit www.interceptpharma.com or connect with the company on Twitter and LinkedIn.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements regarding the progress, timing and results of our clinical trials, including our clinical trials for the treatment of nonalcoholic steatohepatitis ("NASH"), the safety and efficacy of our approved product, Ocaliva (obeticholic acid or "OCA") for primary biliary cholangitis ("PBC"), and our product candidates, including OCA for liver fibrosis due to NASH, the timing and acceptance of our regulatory filings and the potential approval of OCA for liver fibrosis due to NASH, the review of our New Drug Application for OCA for the treatment of liver fibrosis due to NASH by the U.S. Food and Drug Administration (FDA), our intent to work with the FDA to address the issues raised in the complete response letter (CRL), the potential commercial success of OCA, as well as our strategy, future operations, future financial position, future revenue, projected costs, financial guidance, prospects, plans and objectives.

    These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "possible," "continue" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement except as required by law. These forward-looking statements are based on estimates and assumptions by our management that, although believed to be reasonable, are inherently uncertain and subject to a number of risks. The following represent some, but not necessarily all, of the factors that could cause actual results to differ materially from historical results or those anticipated or predicted by our forward-looking statements: our ability to successfully commercialize Ocaliva for PBC; our ability to maintain our regulatory approval of Ocaliva for PBC in the United States, Europe, Canada, Israel, Australia and other jurisdictions in which we have or may receive marketing authorization; our ability to timely and cost-effectively file for and obtain regulatory approval of our product candidates on an accelerated basis or at all, including OCA for liver fibrosis due to NASH following the issuance of the CRL by the FDA; any advisory committee recommendation or dispute resolution determination that our product candidates, including OCA for liver fibrosis due to NASH, should not be approved or approved only under certain conditions; any future determination that the regulatory applications and subsequent information we submit for our product candidates, including OCA for liver fibrosis due to NASH, do not contain adequate clinical or other data or meet applicable regulatory requirements for approval; conditions that may be imposed by regulatory authorities on our marketing approvals for our products and product candidates, including OCA for liver fibrosis due to NASH, such as the need for clinical outcomes data (and not just results based on achievement of a surrogate endpoint), any risk mitigation programs such as a REMS, and any related restrictions, limitations and/or warnings contained in the label of any of our products or product candidates; any potential side effects associated with Ocaliva for PBC, OCA for liver fibrosis due to NASH or our other product candidates that could delay or prevent approval, require that an approved product be taken off the market, require the inclusion of safety warnings or precautions, or otherwise limit the sale of such product or product candidate; the initiation, timing, cost, conduct, progress and results of our research and development activities, preclinical studies and clinical trials, including any issues, delays or failures in identifying patients, enrolling patients, treating patients, retaining patients, meeting specific endpoints in the jurisdictions in which we intend to seek approval or completing and timely reporting the results of our NASH or PBC clinical trials; our ability to establish and maintain relationships with, and the performance of, third-party manufacturers, contract research organizations and other vendors upon whom we are substantially dependent for, among other things, the manufacture and supply of our products, including Ocaliva for PBC and, if approved, OCA for liver fibrosis due to NASH, and our clinical trial activities; our ability to identify, develop and successfully commercialize our products and product candidates, including our ability to successfully launch OCA for liver fibrosis due to NASH, if approved; our ability to obtain and maintain intellectual property protection for our products and product candidates, including our ability to cost-effectively file, prosecute, defend and enforce any patent claims or other intellectual property rights; the size and growth of the markets for our products and product candidates and our ability to serve those markets; the degree of market acceptance of Ocaliva for PBC and, if approved, OCA for liver fibrosis due to NASH or our other product candidates among physicians, patients and healthcare payors; the availability of adequate coverage and reimbursement from governmental and private healthcare payors for our products, including Ocaliva for PBC and, if approved, OCA for liver fibrosis due to NASH, and our ability to obtain adequate pricing for such products; our ability to establish and maintain effective sales, marketing and distribution capabilities, either directly or through collaborations with third parties; competition from existing drugs or new drugs that become available; our ability to prevent system failures, data breaches or violations of data protection laws; costs and outcomes relating to any disputes, governmental inquiries or investigations, regulatory proceedings, legal proceedings or litigation, including any securities, intellectual property, employment, product liability or other litigation; our collaborators' election to pursue research, development and commercialization activities; our ability to establish and maintain relationships with collaborators with development, regulatory and commercialization expertise; our need for and ability to generate or obtain additional financing; our estimates regarding future expenses, revenues and capital requirements and the accuracy thereof; our use of cash and short-term investments; our ability to acquire, license and invest in businesses, technologies, product candidates and products; our ability to attract and retain key personnel to manage our business effectively; our ability to manage the growth of our operations, infrastructure, personnel, systems and controls; our ability to obtain and maintain adequate insurance coverage; the impact of COVID-19, including any impact on our results of operations or financial position, related quarantines and government actions, delays relating to our regulatory applications, disruptions relating to our ongoing clinical trials or involving our contract research organizations, study sites or other clinical partners, disruptions relating to our supply chain or involving our third-party manufacturers, distributors or other distribution partners, facility closures or other restrictions, and the extent and duration thereof; the impact of general U.S. and foreign economic, industry, market, regulatory or political conditions, including the potential impact of Brexit; and the other risks and uncertainties identified in our periodic filings filed with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020.

    Contact

    For more information about Intercept, please contact:

    Lisa DeFrancesco

    +1-646-565-4833

    Christopher Frates

    +1-646-757-2371

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  3. New analyses of the interim analysis data from the Phase 3 REGENERATE study describe the benefit of obeticholic acid (OCA) on noninvasive measures of liver fibrosis in NASH patients on treatment for at least 24 months

    Additional long-term data in PBC highlight the safety and durable efficacy of OCA through six years of open label treatment

    NEW YORK, Aug. 21, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that multiple abstracts regarding the treatment of primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH) with OCA will be presented…

    New analyses of the interim analysis data from the Phase 3 REGENERATE study describe the benefit of obeticholic acid (OCA) on noninvasive measures of liver fibrosis in NASH patients on treatment for at least 24 months

    Additional long-term data in PBC highlight the safety and durable efficacy of OCA through six years of open label treatment

    NEW YORK, Aug. 21, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that multiple abstracts regarding the treatment of primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH) with OCA will be presented at the Digital International Liver Congress™ 2020, the 55th Annual Meeting of the European Association for the Study of the Liver (EASL), to be held virtually from August 27, 2020 to August 29, 2020.

    "The new data to be presented at this year's International Liver Congress add to the already substantial body of evidence supporting the anti-fibrotic efficacy of OCA in patients with advanced fibrosis due to NASH," said Mark Pruzanski, M.D., President and CEO of Intercept. "We are also excited to see that several Ocaliva® PBC abstracts that deepen the understanding of our drug's long-term safety and efficacy profile will be presented, including one presenting the six-year data from the open label extension of our Phase 3 POISE trial. On behalf of all my colleagues at Intercept, I'd like to thank EASL for providing this virtual forum for important new hepatology research and scientific exchange during the COVID-19 pandemic."

    Presentations at the Digital International Liver Congress include:

    Late-Breaker Poster Presentation

    "Obeticholic acid demonstrates sustained improvements at month 24 in transaminases and non-invasive markers of fibrosis: results of a post hoc analysis from the interim analysis of the REGENERATE study" (LBP19)

    Rohit Loomba, Vlad Ratziu, Quentin M. Anstee, Stephen Harrison, Arun Sanyal, Mary Rinella, Zobair Younossi, Zachary Goodman, Pierre Bedossa, Reshma Shringarpure, Huafeng Zhou, Aditya Venugopal, Mazen Noureddin

    Oral Presentation

    "Obeticholic acid (OCA) improves experimental non-invasive markers of NASH and advanced fibrosis: results of a secondary analysis from the month-18 interim analysis of the REGENERATE study" (AS075)

    Jerome Boursier, Rohit Loomba, Quentin M. Anstee, Stephen Harrison, Arun Sanyal, Mary Rinella, Zobair Younossi, Zachary Goodman, Pierre Bedossa, Céline Fournier, Michael Stenkilsson, Reshma Shringarpure, Luna Zaru, Aditya Venugopal, Leigh MacConell, Vlad Ratziu

    General Poster Presentations

    "The burden of disease associated with non-alcoholic steatohepatitis patients under standard of care" (THU048)

    Raluca Pais, William Green, Stuart Mealing, Aldo Trylesinski, Sandrine Cure, Heather Davies

    "Predicted risk of end stage liver disease utilizing the UK-PBC risk score with continued standard of care and subsequent addition of obeticholic acid for 60 Months in patients with primary biliary cholangitis" (THU114)

    David E. Jones, Marco Carbone, George Mells, Alexander Liberman, Elizabeth Smoot Malecha, Leigh MacConell

    "Noninvasive tests for assessing fibrosis in patients with non-alcoholic fatty liver disease: an evaluation of combining test results" (FRI009)

    Catherine Vick, Andrew Joyce, Amy Law, Molly Sherwood, Essy Mozaffari, Bruce Wong

    "Obeticholic acid improves hepatic fibroinflammation as assessed by multiparametric magnetic resonance imaging: interim results of the REGENERATE trial" (FRI066)

    Rohit Loomba, Quentin M. Anstee, Stephen Harrison, Arun Sanyal, Vlad Ratziu, Zobair Younossi, Zachary Goodman, Pierre Bedossa, Rajarshi Banerjee, Michael Stenkilsson, Reshma Shringarpure, Luna Zaru, Aditya Venugopal, Leigh MacConell, Mary Rinella

    "Obesity-specific health-related quality of life in patients with non-alcoholic steatohepatitis: results from the REGENERATE study" (FRI080)

    Zobair Younossi, Maria Stepanova, Fatema Nader, Rohit Loomba, Quentin M. Anstee, Vlad Ratziu, Stephen Harrison, Arun Sanyal, Jacob George, Susanne Beckebaum, David Orr, Giuseppe Mazzella, Victor Vargas, Lise Lotte Gluud, Rifaat Safadi, James Trotter, Jaideep Behari, David Sheridan, Muhammad Y. Sheikh, Martin Bonacci, Gail Cawkwell, Bruce Wong, Pierre Bedossa, Zachary Goodman, Mary Rinella, on behalf of the REGENERATE Study Investigators

    "Durability of biochemical improvements through six years of open label treatment with obeticholic acid in patients with primary biliary cholangitis who did not achieve the POISE criteria" (FRI146)

    Gideon M. Hirschfield, Marco Carbone, David E. Jones, Bettina E. Hansen, Andreas E. Kremer, Michael Trauner, Alexander Liberman, Elizabeth Smoot Malecha, Leigh MacConell

    "Efficacy and tolerance of obeticholic acid in patients with primary biliary cholangitis and inadequate response to ursodeoxycholic acid in real life: interim analysis of the OCARELIFE study" (FRI180)

    Vincent Leroy, Christophe Corpechot, Jérôme Dumortier, Laurent Alric, Dominique Larrey, Sébastien Dharancy, Olivier Chazouilleres, Alexandra Heurgue, François Boer, Aldo Trylesinski

    A full list of sessions at the Digital International Liver Congress™ 2020 is available at https://ilc-congress.eu.

    About Liver Fibrosis due to NASH

    Nonalcoholic steatohepatitis (NASH) is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death. Advanced fibrosis is associated with a substantially higher risk of liver-related morbidity and mortality in patients with NASH. In the United States, NASH is currently the second leading cause for liver transplantation overall, and in females, the leading cause. NASH is anticipated to become the leading indication for liver transplantation in Europe within the next decade. There are currently no medications approved for the treatment of NASH.

    About the REGENERATE Study

    REGENERATE is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study assessing the safety and efficacy of obeticholic acid (OCA) on clinical outcomes in patients with liver fibrosis due to NASH. A pre-specified 18-month analysis was conducted to assess the effect of OCA on liver histology comparing month 18 biopsies with baseline. REGENERATE has completed target enrollment for the clinical outcomes cohort, with 2,480 adult NASH patients randomized over 300 qualified centers worldwide, and is expected to continue through clinical outcomes for verification and description of clinical benefit. The end-of-study analysis is designed to evaluate the effect of OCA on all-cause mortality and liver-related clinical outcomes, as well as its long-term safety.

    About Intercept

    Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Founded in 2002 in New York, Intercept has operations in the United States, Europe and Canada. For more information, please visit www.interceptpharma.com or connect with the company on Twitter and LinkedIn.

    About Primary Biliary Cholangitis

    Primary biliary cholangitis (PBC) is a chronic, progressive liver disorder that mostly affects women, afflicting approximately one in 1,000 women over the age of 40. If left untreated, survival of PBC patients is significantly worse than the general population.

    About Ocaliva® (obeticholic acid) 

    Ocaliva is indicated in the United States for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

    This indication is approved under the accelerated approval pathway based on a reduction in alkaline phosphatase (ALP) as a surrogate endpoint which is reasonably likely to predict clinical benefit, including an improvement in liver transplant free-survival. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. We are conducting a Phase 4 clinical outcomes trial, which we refer to as our COBALT trial, of OCA in patients with PBC with the goal of confirming clinical benefit on a post-marketing basis.

    In December 2016, Ocaliva received conditional marketing authorization in Europe for the treatment of PBC in combination with UDCA in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA, conditioned upon us providing further data post-approval to confirm benefit. For detailed safety information for Ocaliva 5 mg and 10 mg tablets including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European Summary of Product Characteristics that can be found on www.ema.europa.eu.

    U.S. IMPORTANT SAFETY INFORMATION FOR OCALIVA IN PBC

    WARNING: HEPATIC DECOMPENSATION AND FAILURE IN INCORRECTLY DOSED PBC PATIENTS WITH CHILD-PUGH CLASS B OR C OR DECOMPENSATED CIRRHOSIS

    • In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with Primary Biliary Cholangitis (PBC) with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when OCALIVA was dosed more frequently than recommended.
    • The recommended starting dosage of OCALIVA is 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event.

    Contraindications

    OCALIVA is contraindicated in PBC patients with complete biliary obstruction.

    Warnings and Precautions

    Hepatic Decompensation and Failure in Incorrectly-Dosed PBC Patients with Child-Pugh Class B or C or Decompensated Cirrhosis

    In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in PBC patients with decompensated cirrhosis or Child-Pugh B or C hepatic impairment when OCALIVA was dosed more frequently than the recommended starting dosage of 5 mg once weekly. Reported cases typically occurred within 2 to 5 weeks after starting OCALIVA and were characterized by an acute increase in total bilirubin and/or ALP concentrations in association with clinical signs and symptoms of hepatic decompensation (e.g., ascites, jaundice, gastrointestinal bleeding, worsening of hepatic encephalopathy).

    Routinely monitor patients for progression of PBC disease, including liver-related complications, with laboratory and clinical assessments. Dosage adjustment, interruption or discontinuation may be required. Close monitoring is recommended for patients at an increased risk of hepatic decompensation. Severe intercurrent illnesses that may worsen renal function or cause dehydration (e.g., gastroenteritis), may exacerbate the risk of hepatic decompensation. Interrupt treatment with OCALIVA in patients with laboratory or clinical evidence of worsening liver function indicating risk of decompensation, and monitor the patient's liver function. Consider discontinuing OCALIVA in patients who have experienced clinically significant liver-related adverse reactions. Discontinue OCALIVA in patients who develop complete biliary obstruction.

    Liver-Related Adverse Reactions

    Dose-related, liver-related adverse reactions including jaundice, worsening ascites and primary biliary cholangitis flare have been observed in clinical trials, as early as one month after starting treatment with OCALIVA 10 mg once daily up to 50 mg once daily (up to 5-times the highest recommended dosage). Monitor PBC patients during treatment with OCALIVA for elevations in liver biochemical tests and for the development of liver-related adverse reactions.

    Severe Pruritus

    Severe pruritus was reported in 23% of PBC patients in the OCALIVA 10 mg arm, 19% of PBC patients in the OCALIVA titration arm, and 7% of PBC patients in the placebo arm in a 12-month double-blind randomized controlled trial of 216 PBC patients. Severe pruritus was defined as intense or widespread itching, interfering with activities of daily living, or causing severe sleep disturbance, or intolerable discomfort, and typically requiring medical interventions. Consider clinical evaluation of PBC patients with new onset or worsening severe pruritus. Management strategies include the addition of bile acid resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing.

    Reduction in HDL-C

    Patients with PBC generally exhibit hyperlipidemia characterized by a significant elevation in total cholesterol primarily due to increased levels of high-density lipoprotein-cholesterol (HDL-C). Dose-dependent reductions from baseline in mean HDL-C levels were observed at 2 weeks in OCALIVA-treated PBC patients, 20% and 9% in the 10 mg and titration arms, respectively, compared to 2% in the placebo arm. Monitor PBC patients for changes in serum lipid levels during treatment. For PBC patients who do not respond to OCALIVA after 1 year at the highest recommended dosage that can be tolerated (maximum of 10 mg once daily), and who experience a reduction in HDL-C, weigh the potential risks against the benefits of continuing treatment.

    Adverse Reactions

    The most common adverse reactions from subjects taking OCALIVA for PBC were pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema. 

    Drug Interactions

    Bile Acid Binding Resins

    Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the absorption, systemic exposure, and efficacy of OCALIVA. If taking a bile acid binding resin, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid binding resin, or at as great an interval as possible.

    Warfarin

    The International Normalized Ratio (INR) decreased following coadministration of warfarin and OCALIVA. Monitor INR and adjust the dose of warfarin, as needed, to maintain the target INR range when coadministering OCALIVA and warfarin.

    CYP1A2 Substrates with Narrow Therapeutic Index

    Obeticholic acid, the active ingredient in OCALIVA, may increase the exposure to concomitant drugs that are CYP1A2 substrates. Therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic index (e.g. theophylline and tizanidine) is recommended when coadministered with OCALIVA.

    Inhibitors of Bile Salt Efflux Pump

    Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. Concomitant medications that inhibit canalicular membrane bile acid transporters such as the BSEP may exacerbate accumulation of conjugated bile salts including taurine conjugate of obeticholic acid in the liver and result in clinical symptoms. If concomitant use is deemed necessary, monitor serum transaminases and bilirubin.

    Please see Full Prescribing Information, including Boxed WARNING and Medication Guide for OCALIVA.

    To report SUSPECTED ADVERSE REACTIONS, contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements regarding the progress, timing and results of our clinical trials, including our clinical trials for the treatment of nonalcoholic steatohepatitis ("NASH"), the safety and efficacy of our approved product, Ocaliva (obeticholic acid or "OCA") for primary biliary cholangitis ("PBC"), and our product candidates, including OCA for liver fibrosis due to NASH, the timing and acceptance of our regulatory filings and the potential approval of OCA for liver fibrosis due to NASH, the review of our New Drug Application for OCA for the treatment of liver fibrosis due to NASH by the U.S. Food and Drug Administration (FDA), our intent to work with the FDA to address the issues raised in the complete response letter (CRL), the potential commercial success of OCA, as well as our strategy, future operations, future financial position, future revenue, projected costs, financial guidance, prospects, plans and objectives.

    These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "possible," "continue" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement except as required by law. These forward-looking statements are based on estimates and assumptions by our management that, although believed to be reasonable, are inherently uncertain and subject to a number of risks. The following represent some, but not necessarily all, of the factors that could cause actual results to differ materially from historical results or those anticipated or predicted by our forward-looking statements: our ability to successfully commercialize Ocaliva for PBC; our ability to maintain our regulatory approval of Ocaliva for PBC in the United States, Europe, Canada, Israel, Australia and other jurisdictions in which we have or may receive marketing authorization; our ability to timely and cost-effectively file for and obtain regulatory approval of our product candidates on an accelerated basis or at all, including OCA for liver fibrosis due to NASH following the issuance of the CRL by the FDA; any advisory committee recommendation or dispute resolution determination that our product candidates, including OCA for liver fibrosis due to NASH, should not be approved or approved only under certain conditions; any future determination that the regulatory applications and subsequent information we submit for our product candidates, including OCA for liver fibrosis due to NASH, do not contain adequate clinical or other data or meet applicable regulatory requirements for approval; conditions that may be imposed by regulatory authorities on our marketing approvals for our products and product candidates, including OCA for liver fibrosis due to NASH, such as the need for clinical outcomes data (and not just results based on achievement of a surrogate endpoint), any risk mitigation programs such as a REMS, and any related restrictions, limitations and/or warnings contained in the label of any of our products or product candidates; any potential side effects associated with Ocaliva for PBC, OCA for liver fibrosis due to NASH or our other product candidates that could delay or prevent approval, require that an approved product be taken off the market, require the inclusion of safety warnings or precautions, or otherwise limit the sale of such product or product candidate; the initiation, timing, cost, conduct, progress and results of our research and development activities, preclinical studies and clinical trials, including any issues, delays or failures in identifying patients, enrolling patients, treating patients, retaining patients, meeting specific endpoints in the jurisdictions in which we intend to seek approval or completing and timely reporting the results of our NASH or PBC clinical trials; our ability to establish and maintain relationships with, and the performance of, third-party manufacturers, contract research organizations and other vendors upon whom we are substantially dependent for, among other things, the manufacture and supply of our products, including Ocaliva for PBC and, if approved, OCA for liver fibrosis due to NASH, and our clinical trial activities; our ability to identify, develop and successfully commercialize our products and product candidates, including our ability to successfully launch OCA for liver fibrosis due to NASH, if approved; our ability to obtain and maintain intellectual property protection for our products and product candidates, including our ability to cost-effectively file, prosecute, defend and enforce any patent claims or other intellectual property rights; the size and growth of the markets for our products and product candidates and our ability to serve those markets; the degree of market acceptance of Ocaliva for PBC and, if approved, OCA for liver fibrosis due to NASH or our other product candidates among physicians, patients and healthcare payors; the availability of adequate coverage and reimbursement from governmental and private healthcare payors for our products, including Ocaliva for PBC and, if approved, OCA for liver fibrosis due to NASH, and our ability to obtain adequate pricing for such products; our ability to establish and maintain effective sales, marketing and distribution capabilities, either directly or through collaborations with third parties; competition from existing drugs or new drugs that become available; our ability to prevent system failures, data breaches or violations of data protection laws; costs and outcomes relating to any disputes, governmental inquiries or investigations, regulatory proceedings, legal proceedings or litigation, including any securities, intellectual property, employment, product liability or other litigation; our collaborators' election to pursue research, development and commercialization activities; our ability to establish and maintain relationships with collaborators with development, regulatory and commercialization expertise; our need for and ability to generate or obtain additional financing; our estimates regarding future expenses, revenues and capital requirements and the accuracy thereof; our use of cash and short-term investments; our ability to acquire, license and invest in businesses, technologies, product candidates and products; our ability to attract and retain key personnel to manage our business effectively; our ability to manage the growth of our operations, infrastructure, personnel, systems and controls; our ability to obtain and maintain adequate insurance coverage; the impact of COVID-19, including any impact on our results of operations or financial position, related quarantines and government actions, delays relating to our regulatory applications, disruptions relating to our ongoing clinical trials or involving our contract research organizations, study sites or other clinical partners, disruptions relating to our supply chain or involving our third-party manufacturers, distributors or other distribution partners, facility closures or other restrictions, and the extent and duration thereof; the impact of general U.S. and foreign economic, industry, market, regulatory or political conditions, including the potential impact of Brexit; and the other risks and uncertainties identified in our periodic filings filed with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020.

    Contact

    For more information about Intercept, please contact:

    Lisa DeFrancesco

    +1-646-565-4833



                                                                                                               

    Christopher Frates

    +1-646-757-2371

    Primary Logo

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  4. Worldwide Ocaliva net sales of $77.2 million in the second quarter 2020, representing 17% growth over the prior year quarter 

    Intercept issues 2020 Ocaliva Net Sales Guidance of $300 to $320 million

    Intercept lowers 2020 non-GAAP Adjusted Operating Expense Guidance by $100 million to $460 million to $500 million

    Preparations Underway for Type A Meeting with FDA on NASH Fibrosis Program

    Conference call scheduled for 8:30 a.m. ET today

    NEW YORK, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced its financial results for the quarter ended June 30…

    Worldwide Ocaliva net sales of $77.2 million in the second quarter 2020, representing 17% growth over the prior year quarter 

    Intercept issues 2020 Ocaliva Net Sales Guidance of $300 to $320 million

    Intercept lowers 2020 non-GAAP Adjusted Operating Expense Guidance by $100 million to $460 million to $500 million

    Preparations Underway for Type A Meeting with FDA on NASH Fibrosis Program

    Conference call scheduled for 8:30 a.m. ET today

    NEW YORK, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced its financial results for the quarter ended June 30, 2020.

    "Our PBC business achieved its highest quarterly net sales to date in the second quarter," said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. "We plan to continue to invest in our growing PBC business and announced 2020 Ocaliva net sales guidance earlier this morning. We anticipate that our Ocaliva net sales, together with the announced reduction in our 2020 non-GAAP adjusted operating expense guidance, will help to ensure that we are financially well positioned to support the path forward in NASH. In the meantime, we are preparing to meet with the FDA to discuss the basis for resubmission of our NDA seeking accelerated approval of OCA for the treatment of advanced fibrosis due to NASH, and continue to believe that OCA has the potential to become the foundational treatment for these patients. I am encouraged by the outpouring of support we have received from the liver community in recent weeks and we remain committed to our goal of bringing the first therapy to market for patients with this serious condition."

    Ocaliva® (obeticholic acid) Commercial Highlights

    We recognized $77.2 million of Ocaliva net sales in the second quarter of 2020, as compared to $65.9 million in the prior year quarter. Ocaliva net sales in the second quarter of 2020 were comprised of U.S. net sales of $59.6 million and ex-U.S. net sales of $17.6 million, as compared to U.S. net sales of $50.7 million and ex-U.S. net sales of $15.2 million in the prior year quarter.

    Selected Second Quarter 2020 Financial Results 

    Revenues 

    We recognized $77.2 million in total revenue in the second quarter of 2020, as compared to $66.3 million in total revenue in the prior year quarter. Total revenue in the second quarter of 2019 included approximately $0.4 million of licensing revenue.

    Operating Expenses

    Our cost of sales were $1.9 million in the second quarter of 2020, as compared to $0.7 million in the prior year quarter. Our cost of sales for the quarters ended June 30, 2020 and 2019 consisted primarily of packaging, labeling, materials and related expenses.

    Our selling, general and administrative expenses increased to $93.4 million in the second quarter of 2020, from $69.7 million in the prior year quarter. The increase was primarily driven by activities associated with our preparation for the potential approval and commercialization of obeticholic acid (OCA) for liver fibrosis due to nonalcoholic steatohepatitis (NASH).

    Our research and development expenses decreased to $34.0 million in the second quarter of 2020, down from $59.6 million in the prior year quarter. The decrease was primarily driven by UK R&D tax credits of $22.0 million recognized as a reduction of research and development expenses during the three months ended June 30, 2020, and lower NASH development costs, based on the completion of enrollment activities for our Phase 3 REGENERATE and REVERSE studies prior to the start of the second quarter of 2020.

    In the quarters ended June 30, 2020 and 2019, we recorded $129.3 million and $130.0 million, respectively, in total operating expenses and $112.4 million and $114.2 million, respectively, in non-GAAP adjusted operating expenses, which excludes non-cash stock-based compensation expense of $16.1 million and $14.8 million, respectively, and depreciation expense of $0.8 million and $0.9 million, respectively.

    References in this press release to "non-GAAP adjusted operating expenses" mean our total operating expenses, as calculated and presented in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), adjusted for the effects of two non-cash items: stock-based compensation and depreciation. See "Non-GAAP Financial Measures" below. A reconciliation of non-GAAP adjusted operating expenses to total operating expenses for all historical periods presented is included below under the heading "Reconciliation of Non-GAAP Adjusted Operating Expenses to Total Operating Expenses."

    Interest Expense

    Interest expense in the quarters ended June 30, 2020 and 2019 was $11.9 million and $9.9 million, respectively. For the quarter ended June 30, 2020, interest expense related to the $460.0 million aggregate principal amount of 3.25% Convertible Senior Notes due 2023 that we issued in July 2016 and the $230.0 million aggregate principal amount of 2.00% Convertible Senior Notes due 2026 (the "2026 Convertible Notes") that we issued in May 2019. 

    Net Loss

    In the second quarter of 2020 we reported a net loss of $63.3 million, a decrease compared to a net loss of $71.4 million in the second quarter 2019.

    Cash Position

    As of June 30, 2020, we had cash, cash equivalents, restricted cash, and investment debt securities available for sale of approximately $540.6 million.  As of December 31, 2019, we had cash, cash equivalents, restricted cash, and investment debt securities available for sale of approximately $657.4 million.

    2020 Financial Guidance

    On June 29, 2020, we announced that the U.S. Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) regarding our New Drug Application (NDA) for OCA for the treatment fibrosis due to NASH.  As a result, we no longer expect to launch OCA for NASH in 2020.

    We are announcing 2020 Ocaliva net sales guidance of $300 million to $320 million, and lowering our previously announced 2020 non-GAAP adjusted operating expenses guidance by $100 million to a range of $460 million to $500 million from a range of $560 million to $600 million.

    See "Non-GAAP Financial Measures" below. A quantitative reconciliation of projected non-GAAP adjusted operating expenses to total operating expenses is not available without unreasonable effort primarily due to our inability to predict with reasonable certainty the amount of future stock-based compensation expense.

    Conference Call on August 10, 2020 at 8:30 a.m. ET

    We are hosting our second quarter 2020 financial results conference call and webcast on August 10, 2020 at 8:30 a.m. ET.  The conference call will be available on the investor page of our website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free domestic) or (315) 625-6894 (international) passcode 5073644. A replay of the call will be available on our website shortly following the completion of the call and will be available for two weeks.

    About Intercept

    Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Founded in 2002 in New York, Intercept has operations in the United States, Europe and Canada. For more information, please visit www.interceptpharma.com or connect with the company on Twitter and LinkedIn.

    Non-GAAP Financial Measures

    This press release presents non-GAAP adjusted operating expenses on a historical and projected basis. For the periods presented, non-GAAP adjusted operating expenses exclude from total operating expenses, as calculated and presented in accordance with GAAP, the effects of two non-cash items: stock-based compensation and depreciation. Non-GAAP adjusted operating expenses is a financial measure that has not been prepared in accordance with GAAP. Accordingly, investors should consider non-GAAP adjusted operating expenses in addition to, but not as a substitute for, total operating expenses that we calculate and present in accordance with GAAP. Among other things, our management uses non-GAAP adjusted operating expenses to establish budgets and operational goals and to manage our business. Other companies may define or use this measure in different ways. We believe that the presentation of non-GAAP adjusted operating expenses provides investors and management with helpful supplemental information relating to operating performance and trends. A table reconciling non-GAAP adjusted operating expenses to total operating expenses for all historical periods presented is included below under the heading "Reconciliation of Non-GAAP Adjusted Operating Expenses to Total Operating Expenses". A quantitative reconciliation of projected non-GAAP adjusted operating expenses to total operating expenses is not available without unreasonable effort primarily due to our inability to predict with reasonable certainty the amount of future stock-based compensation expense.

    About Liver Fibrosis due to NASH

    Nonalcoholic steatohepatitis (NASH) is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death. Advanced fibrosis is associated with a substantially higher risk of liver-related morbidity and mortality in patients with NASH. In the United States, NASH is currently the second leading cause for liver transplantation overall, and in females, the leading cause. NASH is anticipated to become the leading indication for liver transplantation in Europe within the next decade. There are currently no medications approved for the treatment of NASH.

    About the REGENERATE Study

    REGENERATE is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study assessing the safety and efficacy of obeticholic acid (OCA) on clinical outcomes in patients with liver fibrosis due to NASH. A pre-specified 18-month analysis was conducted to assess the effect of OCA on liver histology comparing month 18 biopsies with baseline. REGENERATE has completed target enrollment for the clinical outcomes cohort, with 2,480 adult NASH patients randomized at over 300 qualified centers worldwide, and is expected to continue through clinical outcomes for verification and description of clinical benefit. The end-of-study analysis will evaluate the effect of OCA on all-cause mortality and liver-related clinical outcomes, as well as long-term safety.

    About Ocaliva® (obeticholic acid)

    Ocaliva is indicated in the United States for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

    This indication is approved under the accelerated approval pathway based on a reduction in alkaline phosphatase (ALP) as a surrogate endpoint which is reasonably likely to predict clinical benefit, including an improvement in liver transplant free-survival. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. We are conducting a Phase 4 clinical outcomes trial, which we refer to as our COBALT trial, of OCA in patients with PBC with the goal of confirming clinical benefit on a post-marketing basis.

    In December 2016, Ocaliva received conditional marketing authorization in Europe for the treatment of PBC in combination with UDCA in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA, conditioned upon us providing further data post-approval to confirm benefit. For detailed safety information for Ocaliva 5 mg and 10 mg tablets including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European Summary of Product Characteristics that can be found on www.ema.europa.eu.

    U.S. IMPORTANT SAFETY INFORMATION FOR OCALIVA IN PBC

    WARNING: HEPATIC DECOMPENSATION AND FAILURE IN INCORRECTLY DOSED PBC PATIENTS WITH CHILD-PUGH CLASS B OR C OR DECOMPENSATED CIRRHOSIS

    • In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in patients with Primary Biliary Cholangitis (PBC) with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when OCALIVA was dosed more frequently than recommended.
    • The recommended starting dosage of OCALIVA is 5 mg once weekly for patients with Child-Pugh Class B or C hepatic impairment or a prior decompensation event.

    Contraindications

    OCALIVA is contraindicated in PBC patients with complete biliary obstruction.

    Warnings and Precautions

    Hepatic Decompensation and Failure in Incorrectly-Dosed PBC Patients with Child-Pugh Class B or C or Decompensated Cirrhosis

    In postmarketing reports, hepatic decompensation and failure, in some cases fatal, have been reported in PBC patients with decompensated cirrhosis or Child-Pugh B or C hepatic impairment when OCALIVA was dosed more frequently than the recommended starting dosage of 5 mg once weekly. Reported cases typically occurred within 2 to 5 weeks after starting OCALIVA and were characterized by an acute increase in total bilirubin and/or ALP concentrations in association with clinical signs and symptoms of hepatic decompensation (e.g., ascites, jaundice, gastrointestinal bleeding, worsening of hepatic encephalopathy).

    Routinely monitor patients for progression of PBC disease, including liver-related complications, with laboratory and clinical assessments. Dosage adjustment, interruption or discontinuation may be required. Close monitoring is recommended for patients at an increased risk of hepatic decompensation. Severe intercurrent illnesses that may worsen renal function or cause dehydration (e.g., gastroenteritis), may exacerbate the risk of hepatic decompensation. Interrupt treatment with OCALIVA in patients with laboratory or clinical evidence of worsening liver function indicating risk of decompensation, and monitor the patient's liver function. Consider discontinuing OCALIVA in patients who have experienced clinically significant liver-related adverse reactions. Discontinue OCALIVA in patients who develop complete biliary obstruction.

    Liver-Related Adverse Reactions

    Dose-related, liver-related adverse reactions including jaundice, worsening ascites and primary biliary cholangitis flare have been observed in clinical trials, as early as one month after starting treatment with OCALIVA 10 mg once daily up to 50 mg once daily (up to 5-times the highest recommended dosage). Monitor PBC patients during treatment with OCALIVA for elevations in liver biochemical tests and for the development of liver-related adverse reactions.

    Severe Pruritus

    Severe pruritus was reported in 23% of PBC patients in the OCALIVA 10 mg arm, 19% of PBC patients in the OCALIVA titration arm, and 7% of PBC patients in the placebo arm in a 12-month double-blind randomized controlled trial of 216 PBC patients. Severe pruritus was defined as intense or widespread itching, interfering with activities of daily living, or causing severe sleep disturbance, or intolerable discomfort, and typically requiring medical interventions. Consider clinical evaluation of PBC patients with new onset or worsening severe pruritus. Management strategies include the addition of bile acid resins or antihistamines, OCALIVA dosage reduction, and/or temporary interruption of OCALIVA dosing.

    Reduction in HDL-C

    Patients with PBC generally exhibit hyperlipidemia characterized by a significant elevation in total cholesterol primarily due to increased levels of high-density lipoprotein-cholesterol (HDL-C). Dose-dependent reductions from baseline in mean HDL-C levels were observed at 2 weeks in OCALIVA-treated PBC patients, 20% and 9% in the 10 mg and titration arms, respectively, compared to 2% in the placebo arm. Monitor PBC patients for changes in serum lipid levels during treatment. For PBC patients who do not respond to OCALIVA after 1 year at the highest recommended dosage that can be tolerated (maximum of 10 mg once daily), and who experience a reduction in HDL-C, weigh the potential risks against the benefits of continuing treatment.

    Adverse Reactions

    The most common adverse reactions from subjects taking OCALIVA for PBC were pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema.

    Drug Interactions

    Bile Acid Binding Resins

    Bile acid binding resins such as cholestyramine, colestipol, or colesevelam adsorb and reduce bile acid absorption and may reduce the absorption, systemic exposure, and efficacy of OCALIVA. If taking a bile acid binding resin, take OCALIVA at least 4 hours before or 4 hours after taking the bile acid binding resin, or at as great an interval as possible.

    Warfarin

    The International Normalized Ratio (INR) decreased following coadministration of warfarin and OCALIVA. Monitor INR and adjust the dose of warfarin, as needed, to maintain the target INR range when coadministering OCALIVA and warfarin.

    CYP1A2 Substrates with Narrow Therapeutic Index

    Obeticholic acid, the active ingredient in OCALIVA, may increase the exposure to concomitant drugs that are CYP1A2 substrates. Therapeutic monitoring of CYP1A2 substrates with a narrow therapeutic index (e.g. theophylline and tizanidine) is recommended when coadministered with OCALIVA.

    Inhibitors of Bile Salt Efflux Pump

    Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) such as cyclosporine. Concomitant medications that inhibit canalicular membrane bile acid transporters such as the BSEP may exacerbate accumulation of conjugated bile salts including taurine conjugate of obeticholic acid in the liver and result in clinical symptoms. If concomitant use is deemed necessary, monitor serum transaminases and bilirubin.

    Please see Full Prescribing Information, including Boxed WARNING and Medication Guide for OCALIVA.

    To report SUSPECTED ADVERSE REACTIONS, contact Intercept Pharmaceuticals, Inc. at 1-844-782-ICPT or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements, including, but not limited to, statements regarding the progress, timing and results of our clinical trials, including our clinical trials for the treatment of nonalcoholic steatohepatitis ("NASH"), the safety and efficacy of our approved product, Ocaliva (obeticholic acid or "OCA") for primary biliary cholangitis ("PBC"), and our product candidates, including OCA for liver fibrosis due to NASH, the timing and acceptance of our regulatory filings and the potential approval of OCA for liver fibrosis due to NASH, the review of our New Drug Application for OCA for the treatment of liver fibrosis due to NASH by the U.S. Food and Drug Administration (FDA), our intent to work with the FDA to address the issues raised in the complete response letter (CRL), the potential commercial success of OCA, as well as our strategy, future operations, future financial position, future revenue, projected costs, financial guidance, prospects, plans and objectives.

    These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "possible," "continue" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement except as required by law. These forward-looking statements are based on estimates and assumptions by our management that, although believed to be reasonable, are inherently uncertain and subject to a number of risks. The following represent some, but not necessarily all, of the factors that could cause actual results to differ materially from historical results or those anticipated or predicted by our forward-looking statements: our ability to successfully commercialize Ocaliva for PBC; our ability to maintain our regulatory approval of Ocaliva for PBC in the United States, Europe, Canada, Israel, Australia and other jurisdictions in which we have or may receive marketing authorization; our ability to timely and cost-effectively file for and obtain regulatory approval of our product candidates on an accelerated basis or at all, including OCA for liver fibrosis due to NASH following the issuance of the CRL by the FDA; any advisory committee recommendation or dispute resolution determination that our product candidates, including OCA for liver fibrosis due to NASH, should not be approved or approved only under certain conditions; any future determination that the regulatory applications and subsequent information we submit for our product candidates, including OCA for liver fibrosis due to NASH, do not contain adequate clinical or other data or meet applicable regulatory requirements for approval; conditions that may be imposed by regulatory authorities on our marketing approvals for our products and product candidates, including OCA for liver fibrosis due to NASH, such as the need for clinical outcomes data (and not just results based on achievement of a surrogate endpoint), any risk mitigation programs such as a REMS, and any related restrictions, limitations and/or warnings contained in the label of any of our products or product candidates; any potential side effects associated with Ocaliva for PBC, OCA for liver fibrosis due to NASH or our other product candidates that could delay or prevent approval, require that an approved product be taken off the market, require the inclusion of safety warnings or precautions, or otherwise limit the sale of such product or product candidate; the initiation, timing, cost, conduct, progress and results of our research and development activities, preclinical studies and clinical trials, including any issues, delays or failures in identifying patients, enrolling patients, treating patients, retaining patients, meeting specific endpoints in the jurisdictions in which we intend to seek approval or completing and timely reporting the results of our NASH or PBC clinical trials; our ability to establish and maintain relationships with, and the performance of, third-party manufacturers, contract research organizations and other vendors upon whom we are substantially dependent for, among other things, the manufacture and supply of our products, including Ocaliva for PBC and, if approved, OCA for liver fibrosis due to NASH, and our clinical trial activities; our ability to identify, develop and successfully commercialize our products and product candidates, including our ability to successfully launch OCA for liver fibrosis due to NASH, if approved; our ability to obtain and maintain intellectual property protection for our products and product candidates, including our ability to cost-effectively file, prosecute, defend and enforce any patent claims or other intellectual property rights; the size and growth of the markets for our products and product candidates and our ability to serve those markets; the degree of market acceptance of Ocaliva for PBC and, if approved, OCA for liver fibrosis due to NASH or our other product candidates among physicians, patients and healthcare payors; the availability of adequate coverage and reimbursement from governmental and private healthcare payors for our products, including Ocaliva for PBC and, if approved, OCA for liver fibrosis due to NASH, and our ability to obtain adequate pricing for such products; our ability to establish and maintain effective sales, marketing and distribution capabilities, either directly or through collaborations with third parties; competition from existing drugs or new drugs that become available; our ability to prevent system failures, data breaches or violations of data protection laws; costs and outcomes relating to any disputes, governmental inquiries or investigations, regulatory proceedings, legal proceedings or litigation, including any securities, intellectual property, employment, product liability or other litigation; our collaborators' election to pursue research, development and commercialization activities; our ability to establish and maintain relationships with collaborators with development, regulatory and commercialization expertise; our need for and ability to generate or obtain additional financing; our estimates regarding future expenses, revenues and capital requirements and the accuracy thereof; our use of cash and short-term investments; our ability to acquire, license and invest in businesses, technologies, product candidates and products; our ability to attract and retain key personnel to manage our business effectively; our ability to manage the growth of our operations, infrastructure, personnel, systems and controls; our ability to obtain and maintain adequate insurance coverage; the impact of COVID-19, including any impact on our results of operations or financial position, related quarantines and government actions, delays relating to our regulatory applications, disruptions relating to our ongoing clinical trials or involving our contract research organizations, study sites or other clinical partners, disruptions relating to our supply chain or involving our third-party manufacturers, distributors or other distribution partners, facility closures or other restrictions, and the extent and duration thereof; the impact of general U.S. and foreign economic, industry, market, regulatory or political conditions, including the potential impact of Brexit; and the other risks and uncertainties identified in our periodic filings filed with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020.

    Contact

    For more information about Intercept, please contact:

    Lisa DeFrancesco

    +1-646-565-4833

    Christopher Frates

    +1-646-757-2371

    Intercept Pharmaceuticals, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per share data)

     Three Months Ended

    June 30,


     Six Months Ended

    June 30,


     
      2020  2019  2020  2019 
    Revenue:            
    Product revenue, net$77,249 $65,894 $149,901 $117,741 
    Licensing revenue -  406  -  811 
    Total revenue 77,249  66,300  149,901  118,552 
                 
    Operating expenses:            
    Cost of sales 1,877  677  2,729  1,251 
    Selling, general and administrative 93,360  69,683  191,918  146,910 
    Research and development 34,042  59,599  90,729  117,995 
    Total operating expenses 129,279  129,959  285,376  266,156 
    Operating loss (52,030)  (63,659)  (135,475)  (147,604) 
                 
    Other income (expense):            
    Interest expense (11,933)  (9,884)  (23,710)  (17,723) 
    Other income, net 682  2,123  2,921  3,637 
      (11,251)  (7,761)  (20,789)  (14,086) 
    Net loss$(63,281) $(71,420) $(156,264) $(161,690) 
                 
    Net loss per common and potential common share:            
    Basic and diluted$(1.92) $(2.28) $(4.74) $(5.29) 
                 
    Weighted average common and potential common shares outstanding:            
    Basic and diluted 32,960  31,316  32,941  30,542 
                 

    Condensed Consolidated Balance Sheet Information

    (In thousands)     

     June 30, 

    2020


     December 31, 

    2019 (1)

     (Unaudited)

       
    Cash, cash equivalents, restricted cash and investment debt securities, available for sale$  540,634 $  657,347
    Total assets$637,494 $754,886
    Total liabilities (2)$716,290 $703,330
    Stockholders' equity$(78,796) $51,556

    ––––––––––––

    (1) Derived from the audited financial statements included in Intercept's Annual Report on Form 10-K for the year ended December 31, 2019

    (2) Includes $546.0 million and $532.1 million related to the 2023 Convertible Notes and the 2026 Convertible Notes (together, the "Convertible Notes") as of June 30, 2020 and December 31, 2019, respectively. Intercept separately accounts for the debt and equity components of the Convertible Notes. The aggregate outstanding principal amount of the Convertible Notes was $690.0 million as of June 30, 2020, and December 31, 2019.



    Reconciliation of Non-GAAP Adjusted Operating Expenses to Total Operating Expenses

    (Unaudited)

    (In thousands)     

     Three Months Ended

    June 30,


     Six Months Ended

    June 30,


      2020  2019  2020  2019
    Total operating expenses$129,279 $129,959 $285,376 $266,156
                
    Adjustments:           
    Stock-based compensation 16,083  14,782  28,556  29,679
    Depreciation 808  929  1,572  1,925
    Non-GAAP adjusted operating expenses$112,388 $114,248 $255,248 $234,552
                

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  5. NEW YORK, Aug. 03, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, will announce its second quarter 2020 financial results prior to market open on Monday, August 10, 2020. The announcement will be followed by a conference call and audio webcast hosted by Intercept management at 8:30 a.m. ET to discuss the results.

    The conference call will be available on the investor page of our website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free domestic) or (315) 625-6894 (international) passcode 5073644. Archived webcasts will be available on Intercept's website…

    NEW YORK, Aug. 03, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, will announce its second quarter 2020 financial results prior to market open on Monday, August 10, 2020. The announcement will be followed by a conference call and audio webcast hosted by Intercept management at 8:30 a.m. ET to discuss the results.

    The conference call will be available on the investor page of our website at http://ir.interceptpharma.com or by calling (855) 232-3919 (toll-free domestic) or (315) 625-6894 (international) passcode 5073644. Archived webcasts will be available on Intercept's website for approximately two weeks.

    About Intercept

    Intercept is a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, including primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH). Founded in 2002 in New York, Intercept has operations in the United States, Europe and Canada. For more information, please visit www.interceptpharma.com or connect with the company on Twitter and LinkedIn.

    CONTACT

    For more information about Intercept, please contact:

    Investor inquiries: 

    Media inquiries:

    Source: Intercept Pharmaceuticals, Inc.

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