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U.S. Ocaliva® net sales of $77.6 million; 16.4% growth over the prior year quarter
Company increases 2022 Ocaliva non-GAAP adjusted net sales guidance to $340 million to $350 million and narrows non-GAAP adjusted operating expense guidance to $350 million to $365 million
As of September 30, 2022, Company has cash, cash equivalents, restricted cash, and investment debt securities available for sale of $497.8 million
Company remains on track to resubmit new drug application (NDA) for obeticholic acid (OCA) in liver fibrosis due to NASH by end of 2022 based on the positive Phase 3 REGENERATE study
MORRISTOWN, N.J., Nov. 01, 2022 (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 September 30, 2022.
“We drove accelerated, double-digit growth in Ocaliva this quarter, resulting in an increase to our sales guidance for this year,” said Jerry Durso, President and Chief Executive Officer of Intercept. “This quarter’s performance reinforces the underlying strength and value of our PBC business, and there is significant opportunity to grow this franchise given the number of patients who remain eligible for second-line therapy. Importantly, the long-term outcomes data we are generating reinforce the role Ocaliva can play in the future of PBC treatment.”
“In the near term, we remain on track to resubmit our NDA in liver fibrosis due to NASH by the end of this year, based on the second positive interim analysis of our Phase 3 REGENERATE study,” Durso continued. “There will also be additional data from the REGENERATE study presented in a late-breaking oral presentation at The Liver Meeting® later this month. Importantly, given the recent strategic transactions that have strengthened our capital structure, we are well-positioned financially to manage this critical time while building for the future.”
Program Highlights
Primary Biliary Cholangitis (PBC)
Nonalcoholic Steatohepatitis (NASH)
Pipeline
Financial Results
Revenue
Operating Expenses
Cost of Sales
Sales, General & Administrative Expenses
Research & Development Expenses
Interest Expense
Net Income/Loss
Cash Position
Capital Structure
Convertible Secured Notes Repurchase
2022 Financial Guidance
We are updating our full year 2022 guidance:
This guidance includes our international business for the first six months of the year and our ongoing U.S. business for the full year.
See “Non-GAAP Financial Measures” below. A quantitative reconciliation of projected non-GAAP adjusted net sales to total revenue is included below under the heading “Reconciliation of Non-GAAP Adjusted Net Sales to Total Revenue”. 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 November 1, 2022, at 8:30 a.m. ET
We are hosting our third quarter 2022 financial results conference call and webcast on November 1, 2022, at 8:30 a.m. ET. The conference call will be available via a listen-only webcast on the investor page of our website at http://ir.interceptpharma.com. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the call. A replay of the call will be available on our website shortly following the completion of the call and will be available for one year.
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). 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 net sales and non-GAAP adjusted operating expenses on a historical and projected basis. For the periods presented, non-GAAP adjusted net sales include in total revenue, as calculated and presented in GAAP, the effect of one item: total revenue from discontinued operations. 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 and one item for discontinued operations. Non-GAAP adjusted net sales and adjusted operating expenses are financial measures that have not been prepared in accordance with GAAP. Accordingly, investors should consider non-GAAP adjusted net sales and adjusted operating expenses in addition to, but not as a substitute for, total revenue and 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 net sales and 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 net sales to total revenue for all historical periods presented is included below under the heading “Reconciliation of Non-GAAP Adjusted Net Sales to Total Revenue”. 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 net sales to total revenue is included below under the heading “Reconciliation of Non-GAAP Adjusted Net Sales to Total Revenue”. 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 and Cirrhosis due to Nonalcoholic Steatohepatitis (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. There are currently no medications approved for the treatment of NASH.
About the REGENERATE Study
REGENERATE (Randomized Global Phase 3 Study to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment) is an ongoing Phase 3, randomized, double-blind, placebo-controlled, multicenter, international 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 interim analysis was conducted on 931 subjects who had scheduled biopsy at Month 18 to assess the effect of OCA on liver histology comparing Month 18 biopsies with baseline biopsies. REGENERATE is fully enrolled with 2,480 randomized participants 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 the REVERSE Study
REVERSE is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study evaluating the safety and efficacy of OCA in NASH patients with compensated cirrhosis. The primary endpoint is the percentage of patients with histological improvement in fibrosis by at least one stage with no worsening of NASH using the NASH Clinical Research Network (CRN) scoring system after 18 months of treatment. Over 900 patients have been randomized in a 1:1:1 ratio to the three treatment arms: once-daily OCA 10 mg, once-daily OCA 10 mg for the first three months with titration in accordance with the study protocol up to OCA 25 mg for the remaining study period, or once-daily placebo. Patients who successfully completed the double-blind phase of REVERSE were eligible to enroll in an open-label extension phase of the study for up to 12 additional months.
About Ocaliva® (obeticholic acid)
OCALIVA, a farnesoid X receptor (FXR) agonist, is indicated for the treatment of adult patients with primary biliary cholangitis (PBC)
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). 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.
IMPORTANT SAFETY INFORMATION
WARNING: HEPATIC DECOMPENSATION AND FAILURE IN PRIMARY BILIARY CHOLANGITIS PATIENTS WITH CIRRHOSIS
Contraindications
OCALIVA is contraindicated in patients with:
Warnings and Precautions
Hepatic Decompensation and Failure in PBC Patients with Cirrhosis
Hepatic decompensation and failure, sometimes fatal or resulting in liver transplant, have been reported with OCALIVA treatment in PBC patients with cirrhosis, either compensated or decompensated. Among post-marketing cases reporting it, median time to hepatic decompensation (e.g., new onset ascites) was 4 months for patients with compensated cirrhosis; median time to a new decompensation event (e.g., hepatic encephalopathy) was 2.5 months for patients with decompensated cirrhosis.
Some of these cases occurred in patients with decompensated cirrhosis when they were treated with higher than the recommended dosage for that patient population; however, cases of hepatic decompensation and failure have continued to be reported in patients with decompensated cirrhosis even when they received the recommended dosage.
Hepatotoxicity was observed in the OCALIVA clinical trials. A dose-response relationship was observed for the occurrence of hepatic adverse reactions including jaundice, worsening ascites, and primary biliary cholangitis flare with dosages of OCALIVA of 10 mg once daily to 50 mg once daily (up to 5-times the highest recommended dosage), as early as one month after starting treatment with OCALIVA in two 3-month, placebo-controlled clinical trials in patients with primarily early stage PBC.
Routinely monitor patients for progression of PBC, including hepatic adverse reactions, with laboratory and clinical assessments to determine whether drug discontinuation is needed. Closely monitor patients with compensated cirrhosis, concomitant hepatic disease (e.g., autoimmune hepatitis, alcoholic liver disease), and/or with severe intercurrent illness for new evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), or increases above the upper limit of normal in total bilirubin, direct bilirubin, or prothrombin time to determine whether drug discontinuation is needed. Permanently discontinue OCALIVA in patients who develop laboratory or clinical evidence of hepatic decompensation (e.g., ascites, jaundice, variceal bleeding, hepatic encephalopathy), have compensated cirrhosis and develop evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia), experience clinically significant hepatic adverse reactions, or develop complete biliary obstruction. If severe intercurrent illness occurs, interrupt treatment with OCALIVA and monitor the patient’s liver function. After resolution of the intercurrent illness, consider the potential risks and benefits of restarting OCALIVA treatment.
Severe Pruritus
Severe pruritus was reported in 23% of patients in the OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of patients in the placebo arm in a 12-month double-blind randomized controlled clinical trial of 216 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 patients with new onset or worsening severe pruritus. Management strategies include the addition of bile acid binding 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 patients, 20% and 9% in the 10 mg and titration arms, respectively, compared to 2% in the placebo arm. Monitor patients for changes in serum lipid levels during treatment. For 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 (≥5%) are: pruritus, fatigue, abdominal pain and discomfort, rash, oropharyngeal pain, dizziness, constipation, arthralgia, thyroid function abnormality, and eczema.
Drug Interactions
Please click here for Full Prescribing Information, including Boxed WARNING.
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:
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 their dates, 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:
Contact
For more information about Intercept, please contact:
For investors:
Nareg Sagherian, Executive Director, Global Investor Relations
investors@interceptpharma.com
For media:
Karen Preble, Executive Director, Global Corporate Communications
media@interceptpharma.com
Intercept Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share data) Three Months Ended
September 30,
Nine Months Ended
September 30,
2022 2021 2022 2021 Revenue: Product revenue, net$77,588 $66,640 $208,491 $192,117 Total revenue 77,588 66,640 208,491 192,117 Operating expenses: Cost of sales 424 224 956 771 Selling, general and administrative 43,274 41,271 121,013 130,255 Research and development 44,034 44,712 136,753 132,991 Restructuring - - - (284)Total operating expenses 87,732 86,207 258,722 263,733 Operating loss (10,144) (19,567) (50,231) (71,616) Other income (expense): Interest expense (5,237) (14,095) (18,579) (39,103)(Loss)/gain on extinguishment of debt (91,759) 16,511 (91,739) 16,511 Other income, net 3,053 210 2,691 2,389 Loss from continuing operations$(104,087) $(16,941) $(157,858) $(91,819)Income from discontinued operations, net of tax$371,540 $13,309 $400,499 $36,673 Net income/(loss), net of tax$267,453 $(3,632) $242,641 $(55,146) Net income/(loss) per common and potential common share: Net loss from continuing operations$(3.04) $(0.53) $(5.05) $(2.81)Net income from discontinued operations$10.83 $0.42 $12.81 $1.12 Net income/(loss)$7.80 $(0.11) $7.76 $(1.69) Weighted average common and potential common shares outstanding: Basic and diluted 34,293 31,736 31,262 32,679
Condensed Consolidated Balance Sheet Information
(Unaudited)
(In thousands) September 30,
2022 December 31,
2021 (1) Cash, cash equivalents, restricted cash and investment debt securities, available for sale$497,832 $427,808 Total assets, including current assets of discontinued operations$559,404 $527,023 Total liabilities, including current liabilities of discontinued operations (2)$451,728 $710,985 Stockholders’ equity (deficit)$107,676 $(183,962)
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(1)Derived from the reclassified financial statements included in Intercept's Quarterly Report on Form 10-Q for the period ended September 30, 2022. (2)Includes $332.3 million and $539.8 million related to the 2023 Convertible Notes, 2026 Convertible Notes and the 2026 Secured Convertible Notes (together, the “Convertible Notes”) as of September 30, 2022 and December 31, 2021, respectively. The aggregate outstanding principal amount of the Convertible Notes was $336.3 million as of September 30, 2022 and $729.0 million as of December 31, 2021.
Reconciliation of Non-GAAP Adjusted Net Sales to Total Revenue
(Unaudited)
(In thousands) Three Months Ended
September 30,
Nine Months Ended
September 30,
2022 2021 2022 2021 Total revenue$77,588 $66,640 $208,491 $192,117 Adjustment: ex-U.S. revenue (discontinued operations) - - 58,065 52,760 Non-GAAP adjusted net sales$77,588 $66,640 $266,556 $244,877 2022 Financial Guidance
Low High Total revenue$281,935 $291,935 Adjustment: ex-U.S. revenue (discontinued operations) 58,065 58,065 Non-GAAP adjusted net sales$340,000 $350,000
Reconciliation of Non-GAAP Adjusted Operating Expenses to Total Operating Expenses
(Unaudited)
(In thousands) Three Months Ended
September 30,
Nine Months Ended
September 30,
2022 2021 2022 2021 Total operating expenses$87,732 $86,207 $258,722 $263,733 Adjustments: Add: ex-U.S. operating expenses (discontinued operations) 822 12,840 29,545 42,138 Less: Stock-based compensation 5,788 8,616 21,052 25,483 Depreciation 80 808 2,946 2,557 Non-GAAP adjusted operating expenses$82,686 $89,623 $264,269 $277,831