U.S. Ocaliva® net sales of $77.2 million and $285.7 million for the fourth quarter and full year 2022, representing 13% and 10% growth over the prior year
Worldwide Ocaliva® non-GAAP adjusted net sales of $343.8 million for the full year 2022
As of December 31, 2022, Company has cash, cash equivalents, restricted cash, and investment debt securities available for sale of $490.9 million
PDUFA target action date set for June 22, 2023, for OCA for the treatment of pre-cirrhotic liver fibrosis due to NASH
Company has fully resolved the patent infringement litigation that was scheduled for trial on February 27, 2023; settlements protect Ocaliva market exclusivity into the 2030s
Company to host conference call today at 8:30 a.m. ET
MORRISTOWN, N.J., March 02, 2023 (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 on December 31, 2022.
“2022 was a strong year for Intercept,” said Jerry Durso, President and Chief Executive Officer of Intercept. “We resubmitted our new drug application for OCA in pre-cirrhotic liver fibrosis due to NASH, advanced our pipeline programs in PBC and severe alcohol-associated hepatitis, and successfully delivered double-digit revenue growth for Ocaliva. Moreover, we fully resolved the patent infringement case for Ocaliva that was scheduled for trial this week, reinforcing the long-term opportunity we have in PBC. This progress was complemented by the transformation of our capital structure, positioning us well to manage this exciting period and drive growth.”
“Looking ahead in NASH, we continue to believe that OCA has the potential to become an impactful therapy given the strong and confirmed antifibrotic effect, and manageable safety profile, demonstrated in our landmark Phase 3 REGENERATE study,” Durso continued. “With the acceptance of our NDA and a PDUFA target action date on the horizon, we are focused on advancing through the regulatory review process and preparing for an anticipated commercial launch."
Company Highlights
Primary Biliary Cholangitis (PBC)
Nonalcoholic Steatohepatitis (NASH)
Pipeline
Selected Fourth Quarter and Full Year 2022 Financial Results
Revenues
Operating Expenses
Interest Expense
Net Income/Loss
Cash Position
Capital Structure
Convertible Secured Notes Repurchase
2023 Financial Guidance
Conference Call on March 2, 2023, at 8:30 a.m. ET
The fourth quarter and full-year 2022 financial results conference call and webcast will take place on March 2, 2023, 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), nonalcoholic steatohepatitis (NASH) and severe alcohol-associated hepatitis (sAH). 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 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. 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 interim analysis was conducted in 931 subjects who had a liver biopsy at Month 18 to assess the effect of OCA on liver histology as compared to baseline biopsies. REGENERATE is fully enrolled with 2,480 randomized participants and is expected to continue while collecting data on the incidence of clinical outcomes for verification and description of clinical benefit. The end-of-study primary endpoint will compare the impact of treatment group (placebo, OCA 10 mg or OCA 25 mg daily) on all-cause mortality and liver-related clinical outcomes, as well as on long-term safety.
About Primary Biliary Cholangitis
Primary biliary cholangitis (PBC) is a rare, progressive and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent (approximately 1 in 10,000) in women over the age of 40. PBC causes bile acid to build up in the liver, resulting in inflammation and scarring (fibrosis), which, if left untreated, can lead to cirrhosis, a liver transplant, or death.
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
[email protected]
For media:
Karen Preble, Executive Director, Global Corporate Communications
[email protected]
Intercept Pharmaceuticals, Inc. | |||||||||||||||
Condensed Consolidated Statements of Operations | |||||||||||||||
(Unaudited) | |||||||||||||||
(In thousands, except per share data) | |||||||||||||||
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Revenue: | |||||||||||||||
Product revenue, net | $ | 77,219 | $ | 68,633 | $ | 285,710 | $ | 260,750 | |||||||
Total revenue | 77,219 | 68,633 | 285,710 | 260,750 | |||||||||||
Operating expenses: | |||||||||||||||
Cost of sales | 29 | 404 | 984 | 1,205 | |||||||||||
Selling, general and administrative | 55,418 | 46,338 | 176,303 | 177,488 | |||||||||||
Research and development | 40,681 | 51,067 | 176,639 | 182,747 | |||||||||||
Restructuring | - | - | - | (284) | |||||||||||
Total operating expenses | 96,128 | 97,809 | 353,926 | 361,156 | |||||||||||
Operating loss | (18,909) | (29,176) | (68,216) | (100,406) | |||||||||||
Other income (expense): | |||||||||||||||
Interest expense | (2,806) | (15,317) | (21,385) | (54,419) | |||||||||||
(Loss)/gain on extinguishment of debt | - | - | (91,778) | 16,511 | |||||||||||
Other income, net | 4,172 | (103) | 6,521 | 1,962 | |||||||||||
Loss from continuing operations | $ | (17,543) | $ | (44,596) | $ | (174,858) | $ | (136,352) | |||||||
(Loss)/Income from discontinued operations, net of tax | $ | (3,281) | $ | 8,315 | $ | 396,674 | $ | 44,926 | |||||||
Net (loss)/income, net of tax | $ | (20,824) | $ | (36,281) | $ | 221,816 | $ | (91,426) | |||||||
Net income/(loss) per common and potential common share: | |||||||||||||||
Net loss from continuing operations | $ | (0.42) | $ | (1.51) | $ | (5.17) | $ | (4.28) | |||||||
Net (loss)/income from discontinued operations | $ | (0.08) | $ | 0.28 | $ | 11.72 | $ | 1.41 | |||||||
Net (loss)/income | $ | (0.50) | $ | (1.23) | $ | 6.56 | $ | (2.87) | |||||||
Weighted average common and potential common shares outstanding: | |||||||||||||||
Basic and diluted | 41,479 | 29,563 | 33,837 | 31,894 | |||||||||||
Condensed Consolidated Balance Sheet Information | |||||||
(Unaudited) | |||||||
(In thousands) | |||||||
December 31, 2022 | December 31, 2021 (1) | ||||||
Cash, cash equivalents, restricted cash and investment debt securities, available for sale | $ | 490,909 | $ | 427,808 | |||
Total assets, including current assets of discontinued operations | $ | 553,711 | $ | 527,023 | |||
Total liabilities, including current liabilities of discontinued operations (2) | $ | 460,634 | $ | 710,985 | |||
Stockholders’ equity (deficit) | $ | 93,077 | $ | (183,962 | ) | ||
(1) Derived from the reclassified financial statements included in Intercept's Annual Report on Form 10-K for the period ended December 31, 2022 to conform with discontinued operations presentation.
(2) Includes $332.7 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 December 31, 2022 and December 31, 2021, respectively. The aggregate outstanding principal amount of the Convertible Notes was $336.3 million as of December 31, 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 December 31, | Twelve Months Ended December 31, | |||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||
Total revenue | $ | 77,219 | $ | 68,633 | $ | 285,710 | $ | 260,750 | ||||
Adjustment: | ||||||||||||
ex-U.S. revenue (discontinued operations) | - | - | 58,065 | 52,760 | ||||||||
Non-GAAP adjusted net sales | $ | 77,219 | $ | 68,633 | $ | 343,775 | $ | 313,510 |
Reconciliation of Non-GAAP Adjusted Operating Expenses to Total Operating Expenses | ||||||||||||
(Unaudited) | ||||||||||||
(In thousands) | ||||||||||||
Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||
Total operating expenses | $ | 96,128 | $ | 97,809 | $ | 353,926 | $ | 361,156 | ||||
Adjustments: | ||||||||||||
Add: ex-U.S. operating expenses (discontinued operations) | 227 | 15,461 | 30,683 | 57,985 | ||||||||
Less: Stock-based compensation | 5,338 | 8,405 | 26,390 | 33,888 | ||||||||
Depreciation | 92 | 421 | 3,038 | 2,978 | ||||||||
Non-GAAP adjusted operating expenses | $ | 90,925 | $ | 104,444 | $ | 355,181 | $ | 382,275 |
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