08/03/2022 | Press release | Distributed by Public on 08/03/2022 05:05
Worldwide Ocaliva® non-GAAP adjusted net sales in PBC of $100.4 million; U.S. net sales of $71.8 million representing 5% growth over the prior year quarter
Company reissues 2022 financial guidance to reflect impact of sale of international business: Ocaliva non-GAAP adjusted net sales guidance of $325 million to $345 million and non-GAAP adjusted operating expense guidance of $335 million to $365 million
Intercept completed the sale of its international business for $405 million in upfront consideration on July 1, 2022
Following pre-submission meeting with FDA, Company to resubmit new drug application (NDA) in liver fibrosis due to NASH by end of 2022
MORRISTOWN, N.J., Aug. 03, 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 June 30, 2022.
"This is a transformative time for Intercept," said Jerry Durso, President and Chief Executive Officer of Intercept. "The recent sale of our international business significantly strengthened our balance sheet and now, more than ever, we are poised to continue driving long term growth of Ocaliva in PBC while also building for future success."
"Regarding NASH, we are thrilled with the results of the topline readout we announced last month from our landmark REGENERATE study in patients with fibrosis due to NASH," Durso continued. "In addition to reinforcing the efficacy of OCA as an antifibrotic, with this second analysis, we now have the benefit of a deeper understanding of safety over a longer period of time. We had a constructive pre-submission meeting with FDA in July, and we look forward to resubmitting our NDA by the end of the year. Given the data we have gathered, we are confident in the improved benefit:risk profile of OCA and its potential role as the first therapy in NASH."
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 Loss
Cash Position
2022 Financial Guidance
After previously suspending guidance due to the impact and lack of clarity on the timing for closing the sale of our international business, we are reissuing our full year 2022 guidance:
This guidance includes our international business for the first six months of the year and our ongoing business for the remainder of the 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 August 3, 2022, at 8:30 a.m. ET
We are hosting our second quarter 2022 financial results conference call and webcast on August 3, 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 complete the double-blind phase of REVERSE will be eligible to enroll in an open-label extension phase 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.
SeverePruritus
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 June 30, |
Six Months Ended June 30, |
|||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||
Revenue: | ||||||||||||
Product revenue, net | $ | 71,757 | $ | 68,178 | $ | 130,903 | $ | 125,477 | ||||
Total revenue | 71,757 | 68,178 | 130,903 | 125,477 | ||||||||
Operating expenses: | ||||||||||||
Cost of sales | 309 | 254 | 532 | 547 | ||||||||
Selling, general and administrative | 39,985 | 43,882 | 77,739 | 88,984 | ||||||||
Research and development | 44,826 | 37,668 | 92,719 | 88,279 | ||||||||
Restructuring | - | (160 | ) | - | (284 | ) | ||||||
Total operating expenses | 85,120 | 81,644 | 170,990 | 177,526 | ||||||||
Operating loss | (13,363 | ) | (13,466 | ) | (40,087 | ) | (52,049 | ) | ||||
Other income (expense): | ||||||||||||
Interest expense | (6,669 | ) | (12,589 | ) | (13,342 | ) | (25,008 | ) | ||||
Other (expense)/income, net | (289 | ) | 721 | (342 | ) | 2,179 | ||||||
Loss from continuing operations | $ | 20,321 | $ | 25,334 | $ | 53,771 | $ | 74,878 | ||||
Income from discontinued operations | $ | 12,793 | $ | 14,240 | $ | 28,959 | $ | 23,364 | ||||
Net loss | $ | (7,528 | ) | $ | (11,094 | ) | $ | (24,812 | ) | $ | (51,514 | ) |
Net income/(loss) per common and potential common share: | ||||||||||||
Net loss from continuing operations | $ | (0.68 | ) | $ | (0.76 | ) | $ | (1.81 | ) | $ | (2.26 | ) |
Net income from discontinued operations | $ | 0.43 | $ | 0.43 | $ | 0.97 | $ | 0.70 | ||||
Net loss | $ | (0.25 | ) | $ | (0.33 | ) | $ | (0.83 | ) | $ | (1.55 | ) |
Weighted average common and potential common shares outstanding: | ||||||||||||
Basic and diluted | 29,747 | 33,179 | 29,721 | 33,159 | ||||||||
Condensed Consolidated Balance Sheet Information
(Unaudited)
(In thousands)
June 30, 2022 |
December 31, 2021 (1) |
|||||
Cash, cash equivalents, restricted cash and investment debt securities, available for sale |
$ |
412,313 |
$ |
427,808 |
||
Total assets, including current assets of discontinued operations | $ | 498,597 | $ | 527,023 | ||
Total liabilities, including current liabilities of discontinued operations (2) | $ | 868,430 | $ | 710,985 | ||
Stockholders' deficit | $ | (369,833 | ) | $ | (183,962 | ) |
------------
(1) | Derived from the reclassified financial statements included in Intercept's Quarterly Report on Form 10-Q for the period ended June 30, 2022. | |
(2) | Includes $713.9 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 June 30, 2022 and December 31, 2021, respectively. The aggregate outstanding principal amount of the Convertible Notes was $725.2 million as of June 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 June 30, |
Six Months Ended June 30, |
||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||
Total revenue | $ | 71,757 | $ | 68,178 | $ | 130,903 | $ | 125,477 | |||
Adjustment: | |||||||||||
ex-U.S. revenue (discontinued operations) | 28,628 | 28,398 | 58,065 | 52,760 | |||||||
Non-GAAP adjusted net sales | $ | 100,385 | $ | 96,576 | $ | 188,968 | $ | 178,237 |
2022 Financial Guidance | |||||
Low |
High | ||||
Total revenue | $ | 266,935 | $ | 286,935 | |
Adjustment: | |||||
ex-U.S. revenue (discontinued operations) | 58,065 | 58,065 | |||
Non-GAAP adjusted net sales | $ | 325,000 | $ | 345,000 |
Reconciliation of Non-GAAP Adjusted Operating Expenses to Total Operating Expenses
(Unaudited)
(In thousands)
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||
Total operating expenses | $ | 85,120 | $ | 81,644 | $ | 170,990 | $ | 177,526 | |||
Adjustments: | |||||||||||
Add: ex-U.S. operating expenses (discontinued operations) | 15,739 | 14,172 | 28,723 | 29,298 | |||||||
Less: Stock-based compensation | 8,543 | 8,448 | 15,264 | 16,867 | |||||||
Depreciation | 2,491 | 879 | 2,866 | 1,749 | |||||||
Non-GAAP adjusted operating expenses | $ | 89,825 | $ | 86,489 | $ | 181,583 | $ | 188,208 |
Source: Intercept Pharmaceuticals, Inc.