ICPT Intercept Pharmaceuticals Inc.

23.05
-5.55  -19%
Previous Close 28.6
Open 28.82
52 Week Low 23
52 Week High 98.03
Market Cap $760,310,688
Shares 32,992,436
Float 20,812,122
Enterprise Value $1,001,815,300
Volume 2,377,476
Av. Daily Volume 1,130,007
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Upcoming Catalysts

Drug Stage Catalyst Date
Ocaliva - Obeticholic acid (OCA) - REVERSE
NASH patients with compensated cirrhosis
Phase 3
Phase 3
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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.
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. Worldwide Ocaliva® net sales of $83.3 million and $312.7 million for the fourth quarter and full year 2020, representing 18% and 25% growth over the prior year

    Intercept provides initial 2021 Worldwide Ocaliva Net Sales Guidance of $325 million to $355 million and Non-GAAP Adjusted Operating Expense Guidance of $380 to $410 million

    FDA interactions remain ongoing regarding newly identified safety signal (NISS) for liver disorder in a subset of PBC patients with cirrhosis; Update to Ocaliva label expected  

    Anticipated readout of REVERSE Phase 3 study in compensated cirrhosis due to NASH by end of 2021
            
    Conference call scheduled for 8:30 a.m. ET today

    NEW YORK, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (NASDAQ…

    Worldwide Ocaliva® net sales of $83.3 million and $312.7 million for the fourth quarter and full year 2020, representing 18% and 25% growth over the prior year

    Intercept provides initial 2021 Worldwide Ocaliva Net Sales Guidance of $325 million to $355 million and Non-GAAP Adjusted Operating Expense Guidance of $380 to $410 million

    FDA interactions remain ongoing regarding newly identified safety signal (NISS) for liver disorder in a subset of PBC patients with cirrhosis; Update to Ocaliva label expected  

    Anticipated readout of REVERSE Phase 3 study in compensated cirrhosis due to NASH by end of 2021

            

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

    NEW YORK, Feb. 25, 2021 (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 fourth quarter and full year ended December 31, 2020.

    "As we turn the page on 2020, I am proud of the Intercept team's efforts to support patients with PBC and grow our Ocaliva foundational rare disease franchise during a global pandemic," said Jerry Durso, President and Chief Executive Officer of Intercept. "We continued our regulatory dialogue with FDA and EMA and met with the FDA in Q1 regarding the NISS for liver disorder in a subset of PBC patients with cirrhosis. While interactions remain ongoing, the process will ultimately result in a change to our label regarding the use of Ocaliva to treat patients who reach the most advanced stages of PBC."

    "Regarding our NASH regulatory process, we are laser-focused on building alignment with FDA in advance of a potential NDA resubmission, with the goal of increasing the probability of a successful outcome for patients with advanced fibrosis due to NASH," Durso continued. "We are also looking forward to topline results from our phase 3 REVERSE trial in patients with compensated cirrhosis due to NASH this year."

    Ocaliva® (obeticholic acid) Commercial Highlights

    Full year 2020 Ocaliva net sales were $312.7 million, which represented growth of 25% as compared to the prior year. Ocaliva net sales in 2020 were comprised of U.S. net sales of $234.0 million and ex-U.S. net sales of $78.7 million, as compared to U.S. net sales of $187.5 million and ex-U.S. net sales of $62.1 million in 2019.

    We recognized $83.3 million of Ocaliva net sales in the fourth quarter of 2020, as compared to $70.3 million in the prior year quarter. Ocaliva net sales in the fourth quarter of 2020 were comprised of U.S. net sales of $64.9 million and ex-U.S. net sales of $18.4 million, as compared to U.S. net sales of $53.5 million and ex-U.S. net sales of $16.8 million in the prior year quarter.

    Selected Fourth Quarter and Full Year 2020 Financial Results 

    Revenues 

    We recognized $83.3 million in total revenue in the fourth quarter of 2020, as compared to $71.5 million in total revenue in the prior year quarter. Total revenue in the fourth quarter of 2019 included approximately $1.2 million of licensing revenue.

    We recognized $312.7 million in total revenue in 2020, as compared to $252.0 million in 2019. Total revenue in 2019 included $249.6 million of Ocaliva net sales and approximately $2.4 million of licensing revenue.

    Operating Expenses

    Our cost of sales was $0.8 million in the fourth quarter of 2020, as compared to $2.5 million in the prior year quarter. Cost of sales was $5.3 million in 2020, as compared to $4.2 million in 2019. Our cost of sales for the quarters and years ended December 31, 2020 and 2019 consisted primarily of packaging, labeling, materials and related expenses.

    Our selling, general and administrative expenses decreased to $70.0 million in the fourth quarter of 2020, from $93.7 million in the prior year quarter. The fourth quarter period-over-period decrease was primarily driven by reductions in spend resulting from actions taken following the delay of the potential approval and commercialization of obeticholic acid (OCA) for liver fibrosis due to nonalcoholic steatohepatitis (NASH).  Selling, general and administrative expenses increased to $332.5 million in 2020, up from $317.4 million in 2019. The full year period-over-period increase was primarily driven by expenses during the first half of 2020 relating to our launch preparation activities associated with the potential approval and commercialization of OCA for liver fibrosis due to NASH.

    Our research and development expenses decreased to $51.9 million in the fourth quarter of 2020, from $64.6 million in the prior year quarter. The fourth quarter period-over-period decrease was primarily driven by lower NASH development costs and the conclusion of enrollment activities for the REGENERATE and REVERSE studies.  Research and development expenses decreased to $191.5 million in 2020, down from $242.8 million in 2019. The full year period-over-period decrease was primarily driven by UK R&D tax credits of $22.0 million recognized as a reduction of research and development expenses, and lower NASH development costs and the conclusion of enrollment activities for the REGENERATE and REVERSE studies.

    Restructuring expenses were $1.2 million and $0 for the three months ended December 31, 2020 and 2019, respectively. Restructuring expenses were $14.6 million and $0 for the full year ended December 31, 2020 and 2019, respectively. The fourth quarter and full year period-over-period increases were both driven by severance costs and other related termination benefits incurred in conjunction with the 2020 Workforce Plan.

    In the quarters ended December 31, 2020 and 2019, we recorded $123.9 million and $160.8 million, respectively, in total operating expenses and $106.6 million and $146.8 million, respectively, in non-GAAP adjusted operating expenses, which excludes non-cash stock-based compensation expense of $16.5 million and $13.2 million, respectively, and depreciation expense of $0.8 million and $0.8 million, respectively.

    In the years ended December 31, 2020 and 2019, we recorded $543.9 million and $564.4 million, respectively, in total operating expenses and $480.0 million and $504.8 million, respectively, in non-GAAP adjusted operating expenses, which excludes non-cash stock-based compensation expense of $60.8 million and $56.0 million, respectively, and depreciation expense of $3.1 million and $3.7 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 December 31, 2020 and 2019 was $12.3 million and $11.6 million, respectively. Interest expense in the years ended December 31, 2020 and 2019 was $48.1 million and $41.1 million, respectively. Our interest expense is related to the $460.0 million aggregate principal amount of 3.25% Convertible Senior Notes due 2023 (the "2023 Convertible Notes") 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 fourth quarter and full year of 2020 we reported a net loss of $52.1 million and $274.9 million, respectively, a decrease compared to a net loss of $98.2 million and $344.7 million in the fourth quarter and full year 2019.

    Cash Position

    As of December 31, 2020, we had cash, cash equivalents, restricted cash, and investment debt securities available for sale of approximately $477.2 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.

    2021 Financial Guidance

    Our sales guidance range for full year 2021 provided below reflects the potential impact of various Ocaliva label change scenarios, and we plan to refine this range throughout the year as we have more information from our discussions with FDA. 

    We are announcing 2021 Ocaliva net sales guidance of $325 million to $355 million. In addition, we are announcing 2021 non-GAAP adjusted operating expense guidance of $380 million to $410 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 February 25, 2021 at 8:30 a.m. ET

    We are hosting our fourth quarter and full year 2020 financial results conference call and webcast on February 25, 2021 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 7565656. 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, including in connection with the newly identified safety signal relating to Ocaliva identified by the FDA in May 2020; 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; the outcomes of ongoing discussion with the FDA and the European Medicines Agency regarding the feasibility of the COBALT and 401 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 September 30, 2020.

    Contact

    For more information about Intercept, please contact:

    Caileigh Dougherty

    Christopher Frates



    Intercept Pharmaceuticals, Inc.

    Condensed Consolidated Statements of Operations

    (Unaudited)

    (In thousands, except per share data)        

     Three Months Ended

    December 31,
     Year Ended

    December 31,


      2020   2019   2020   2019 
    Revenue:    
    Product revenue, net$        83,268  $        70,284  $        312,690  $        249,570 
    Licensing revenue -   1,216   -   2,432 
    Total revenue 83,268   71,500   312,690   252,002 
         
    Operating expenses:    
    Cost of sales 767   2,474   5,322   4,212 
    Selling, general and administrative 69,956   93,680   332,493   317,418 
    Research and development 51,898   64,636   191,485   242,799 
    Restructuring 1,249   -   14,630   - 
    Total operating expenses 123,870   160,790   543,930   564,429 
    Operating loss (40,602)  (89,290)  (231,240)  (312,427)
         
    Other income (expense):    
    Interest expense (12,253)  (11,626)  (48,054)  (41,144)
    Other income, net 708   2,758   4,414   8,890 
      (11,545)  (8,868)  (43,640)  (32,254)
    Net loss$         (52,147) $         (98,158) $         (274,880) $         (344,681)
         
    Net loss per common and potential common share:    
    Basic and diluted$         (1.58) $         (2.99) $         (8.34) $         (10.89)
         
    Weighted average common and potential common shares outstanding:    
    Basic and diluted 33,007   32,780   32,970   31,654 



    Condensed Consolidated Balance Sheet Information

    (In thousands)        

     December 31,

    2020
     December 31,

    2019


       
    Cash, cash equivalents, restricted cash and investment debt securities, available for sale



    $




    477,170
      



    $




    657,347
    Total assets$580,489  $754,886
    Total liabilities (1)$747,342  $703,330
    Stockholders' (deficit) equity$    (166,853) $51,556

    ––––––––––––

    (1)Includes $560.6 million and $532.1 million related to the 2023 Convertible Notes and the 2026 Convertible Notes (together, the "Convertible Notes") as of December 31, 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 December 31, 2020, and December 31, 2019.







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

    (Unaudited)

    (In thousands)        

     Three Months Ended

    December 31,
     Year Ended

    December 31,
      2020  2019  2020  2019
    Total operating expenses$123,870 $160,790 $543,930 $564,429
         
    Adjustments:    
    Stock-based compensation 16,469  13,173  60,850  55,982
    Depreciation 836  824  3,118  3,663
    Non-GAAP adjusted operating expenses$106,565 $146,793 $479,962 $504,784


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  2. NEW YORK, Feb. 23, 2021 (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 the appointment of Dagmar Rosa-Bjorkeson to its Board of Directors as of April 1, 2021.

    Ms. Rosa-Bjorkeson has more than 25 years of global experience in the pharmaceutical industry, including executive leadership positions in corporate and product strategy, market development and operational execution. She is currently the Chief Operating Officer of Mesoblast Limited. Ms. Rosa-Bjorkeson has led multiple successful product launches, including Gilenya® for multiple sclerosis at Novartis where…

    NEW YORK, Feb. 23, 2021 (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 the appointment of Dagmar Rosa-Bjorkeson to its Board of Directors as of April 1, 2021.

    Ms. Rosa-Bjorkeson has more than 25 years of global experience in the pharmaceutical industry, including executive leadership positions in corporate and product strategy, market development and operational execution. She is currently the Chief Operating Officer of Mesoblast Limited. Ms. Rosa-Bjorkeson has led multiple successful product launches, including Gilenya® for multiple sclerosis at Novartis where she was Vice President and Head of its multiple sclerosis business unit, Vice President, Business Development and Licensing in the United States, and Country Head and President for Novartis Sweden. Prior to joining Mesoblast, Ms. Rosa-Bjorkeson served as Executive Vice President and President, Biosimilars, at Baxalta, now a wholly owned subsidiary of Takeda Pharmaceutical Company. She was also Executive Vice President and Chief Strategy and Development Officer at Mallinckrodt Pharmaceuticals.

    "Dagmar brings a wealth of insight and experience to the Intercept team and we are very pleased to welcome her to our Board," said Jerry Durso, President and Chief Executive Officer of Intercept. "I'm looking forward to working with Dagmar during this pivotal year for the Company as we focus on enhancing our foundational PBC business, supporting our NASH regulatory process in the United States and Europe, and building our pipeline."

    "Intercept has a strong foundation, with differentiated science and commercial capabilities, and I believe the company has a unique opportunity to capitalize on its leadership position in progressive non-viral liver disease to deliver tremendous value for shareholders, the healthcare community and, most importantly, patients in need," said Ms. Rosa-Bjorkeson.

    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 a 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, including in connection with the newly identified safety signal relating to Ocaliva identified by the FDA in May 2020; 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; the outcomes of ongoing discussions with the FDA and European Medicines Agency regarding the feasibility of the COBALT and 401 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 September 30, 2020.

    CONTACT

    For more information about Intercept, please contact: 

    Lisa DeFrancesco 

    +1-646-565-4833 

     

    Christopher Frates 

    +1-646-757-2371 

     

    Source: Intercept Pharmaceuticals, Inc.



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  3. NEW YORK, Feb. 19, 2021 (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 Jerry Durso, President and Chief Executive Officer, and Sandip Kapadia, Chief Financial Officer of Intercept, will present at the SVB Leerink 10th Annual Global Healthcare Conference on Friday, February 26, 2021 at 1:00 p.m. ET, and at the Cowen 41st Annual Healthcare Conference on Tuesday, March 2, 2021 at 10:30 a.m. ET.

    A live webcast of the events will be available on the investor page of Intercept's website at http://ir.interceptpharma.com. An audio archive of the webcast will also…

    NEW YORK, Feb. 19, 2021 (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 Jerry Durso, President and Chief Executive Officer, and Sandip Kapadia, Chief Financial Officer of Intercept, will present at the SVB Leerink 10th Annual Global Healthcare Conference on Friday, February 26, 2021 at 1:00 p.m. ET, and at the Cowen 41st Annual Healthcare Conference on Tuesday, March 2, 2021 at 10:30 a.m. ET.

    A live webcast of the events 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.

    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: 



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  4. Lisa DeFrancesco, Senior Vice President, Corporate Affairs & Investor Relations, will join Intercept's Executive Leadership Team

    NEW YORK, Feb. 17, 2021 (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 the appointment of Linda Richardson as Chief Commercial Officer. Ms. Richardson was previously Senior Vice President and Head of the Global Cholestasis Program at Intercept, where she has guided long-range planning for Intercept's rare disease franchise in PBC and other cholestatic liver diseases since 2018.

    "Linda's deep global commercial experience makes her an…

    Lisa DeFrancesco, Senior Vice President, Corporate Affairs & Investor Relations, will join Intercept's Executive Leadership Team

    NEW YORK, Feb. 17, 2021 (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 the appointment of Linda Richardson as Chief Commercial Officer. Ms. Richardson was previously Senior Vice President and Head of the Global Cholestasis Program at Intercept, where she has guided long-range planning for Intercept's rare disease franchise in PBC and other cholestatic liver diseases since 2018.

    "Linda's deep global commercial experience makes her an ideal leader for Intercept's next phase of growth and development," said Jerry Durso, President and Chief Executive Officer of Intercept. "Linda will be responsible for overseeing our Ocaliva® franchise in the U.S. and International regions, as well as commercial strategy and execution for future indications and product opportunities."

    Prior to joining Intercept, Ms. Richardson served as Chief Strategy & Commercial Officer at Chimerix, Inc., overseeing marketing, market access and reimbursement, market research and analytics, forecasting, supply chain and distribution strategies, commercial operations, product communications and sales. From 2008 to 2013, she held commercial leadership roles of increasing responsibility at Sanofi, where she oversaw multiple U.S. and global product launches. Prior to joining Sanofi, Ms. Richardson held marketing leadership roles at Reliant Pharmaceuticals and GlaxoSmithKline.

    "Intercept has established a proven track record of commercial execution with the launch of Ocaliva and I believe we have an opportunity to build on this strong foundation to support patients with PBC and other progressive non-viral liver diseases in the future," said Ms. Richardson. "We have an amazing team at Intercept, and it is a great privilege to be taking on this new role during a pivotal year for the company."

    In addition to Ms. Richardson, Lisa DeFrancesco will join Intercept's Executive Leadership Team.

    Ms. DeFrancesco, Senior Vice President, Corporate Affairs & Investor Relations since December 2020, was previously Intercept's Vice President of Investor Relations. Prior to joining Intercept, she served as Senior Vice President, Investor Relations, Corporate Communications and Government Affairs at Melinta Therapeutics where she was a member of the company's Executive Leadership Team. From 2009 to 2017, Ms. DeFrancesco held roles of increasing responsibility at Allergan plc, most recently in the role of Vice President, Investor Relations.

    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 a 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, including in connection with the newly identified safety signal relating to Ocaliva identified by the FDA in May 2020; 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; the outcomes of ongoing discussions with the FDA and European Medicines Agency regarding the feasibility of the COBALT and 401 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 September 30, 2020.

    CONTACT

    For more information about Intercept, please contact: 

    Lisa DeFrancesco 

    +1-646-565-4833 

     

    Christopher Frates 

    +1-646-757-2371 

     

    Source: Intercept Pharmaceuticals, Inc.

     



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  5. DUBLIN, Ireland, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the appointment of Richard Kim to the newly formed role of Chief Commercial Officer. In this role his responsibilities will include leading all aspects of the U.S. commercial launch of the company's lead program, once-nightly FT218, pending regulatory approval.

    "Richard joins our team at an important point in the company's history," said Greg Divis, Chief Executive Officer of Avadel. "Richard has over 25 years of biopharmaceutical commercial experience…

    DUBLIN, Ireland, Feb. 17, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on developing FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy, today announced the appointment of Richard Kim to the newly formed role of Chief Commercial Officer. In this role his responsibilities will include leading all aspects of the U.S. commercial launch of the company's lead program, once-nightly FT218, pending regulatory approval.

    "Richard joins our team at an important point in the company's history," said Greg Divis, Chief Executive Officer of Avadel. "Richard has over 25 years of biopharmaceutical commercial experience with direct leadership of successful product launches in the U.S. and around the world to treat specialty and orphan diseases. His hands-on experience in building world-class teams, capabilities and infrastructure to support the commercial launches of those innovative new drugs will play a critical role at Avadel as we accelerate our commercialization strategy for once-nightly FT218, in preparation for the highly anticipated U.S. regulatory approval."

    "I was drawn to Avadel because of the potential its investigational, once-nightly FT218 product offers as a game changing therapy for patients living with narcolepsy," said Mr. Kim. "I am excited to have the opportunity to work alongside the amazing Avadel team and build upon the positive momentum they have already established for the once-nightly FT218 program, including completion of the pivotal phase 3 study, submission of the NDA to the FDA at the end of last year, and the ongoing preparation for a successful commercial launch."

    "It isn't often that a new product has the potential to offer such a significant advancement in patient care for an established multi-billion dollar market. If approved, I believe FT218 will be the preferred choice for sodium oxybate drug therapy and provide a potentially life-changing option for narcolepsy patients, while creating value for our shareholders," concluded Mr. Kim.

    Mr. Kim has over 25 years of commercialization, marketing, development and managerial experience in the biopharmaceutical industry in the U.S. and abroad. Prior to joining Avadel, he was at Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT), where he most recently served as the President of U.S. Commercial & Strategic Marketing. During his time there he helped to successfully launch OCALIVA™ (obeticholic acid), the first new treatment in nearly 20 years in an orphan disease, Primary Billiary Cholangitis, and led the launch strategy for obeticholic acid for the treatment of NASH. Prior to joining Intercept, Mr. Kim worked at Bristol-Myers Squibb, where he served as General Manager, Hepatitis C Worldwide Commercialization where he led the successful worldwide launch of DAKLINZA™ (daclatasvir) for hepatitis C. Prior to this, Mr. Kim held a number of roles of increasing responsibility leading sales, operational and strategic marketing teams at Bristol-Myers Squibb, including Vice President, SPRYCEL™ Brand Lead, Oncology Global Marketing; Vice President, U.S. In-Line Oncology and Global Marketing; and Vice President, East Area Sales, Cardiovascular and Metabolics. Prior to his time at Bristol-Myers Squibb, Mr. Kim held a range of senior positions in the U.S., Canada and Australia at Schering-Plough, which was acquired by Merck & Co., Inc.

    About FT218

    FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel's MicroPump™ controlled-release (CR) technology. In December 2020, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy. The designation was granted on the plausible hypothesis that FT218 may be clinically superior to the twice-nightly formulation of sodium oxybate already approved by the FDA for the same indication. In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

    About Avadel Pharmaceuticals plc:

    Avadel Pharmaceuticals plc (NASDAQ:AVDL) is a biopharmaceutical company primarily focused on the development and FDA approval of FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. For more information, please visit www.avadel.com.

    Cautionary Disclosure Regarding Forward-Looking Statements

    This press release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, the FDA's review of the NDA for FT218, the benefits of Orphan Drug Exclusivity for FT218, if granted by the FDA, the commercial launch of FT218, if approved, and market acceptance of FT218, if approved. In some cases, forward-looking statements can be identified by the use of words such as "will," "may," "could," "believe," "expect," "look forward," "on track," "guidance," "anticipate," "estimate," "project," "next steps" and similar expressions, and the negatives thereof (if applicable).

    Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the FDA does not approve the NDA for FT218 or such approval is delayed, the risk that FT218 (if approved) may not receive a 7-year Orphan Drug Exclusivity, the risk that commercial launch of FT218 (if approved) is delayed, the risk that the potential market performance for FT218 (if approved) may differ materially from projections, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the "Risk Factors" section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, which we filed with the Securities and Exchange Commission (SEC) on March 16, 2020 and subsequent SEC filings.

    Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.

    Contacts:

    Investor Contacts

    Tom McHugh

    Chief Financial Officer

    Phone: (636) 449-1843

    Email:

    Tim McCarthy

    LifeSci Advisors, LLC

    Phone: (212) 915.2564

    Email:

    Media Contact

    Patrick Bursey

    LifeSci Communications, LLC

    Phone: (646) 970-4688

    Email:



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