NEW YORK, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced its financial results for the quarter ended September 30, 2020.

“We were pleased to reengage with FDA at our recent Type A end-of-review meeting to discuss the Agency’s benefit-risk assessment in the CRL based on its review of the available data, as well as our proposed way forward to resubmitting our NDA for OCA in NASH fibrosis,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “The meeting was constructive and FDA has provided us with helpful guidance regarding supplemental data we can provide to further characterize OCA’s efficacy and safety profile that could support resubmission based on our Phase 3 REGENERATE 18-month biopsy data, together with a safety update from our ongoing studies. We are advancing accordingly and plan to hold additional meetings with the Agency with the goal of achieving sufficient alignment to proceed on this basis and potentially resubmit our NDA next year. Of note, the REGENERATE outcomes phase is ongoing and our Phase 3 REVERSE study in NASH patients with compensated cirrhosis is expected to read out by the end of next year. We continue to lead the NASH field and believe that, if approved, OCA has the potential to become an important treatment for patients with advanced fibrosis due to NASH. Meanwhile, our PBC business continued its strong performance in the third quarter and we have updated our 2020 financial guidance with anticipated Ocaliva net sales of $310 to $320 million and non-GAAP adjusted operating expenses of $460 to $480 million, providing us with a strong financial footing for the future.”

Ocaliva^® (obeticholic acid) Commercial Highlights

We recognized $79.5 million of Ocaliva net sales in the third quarter of 2020, as compared to $61.5 million in the prior year quarter. Ocaliva net sales in the third quarter of 2020 were comprised of U.S. net sales of $58.6 million and ex-U.S. net sales of $20.9 million, as compared to U.S. net sales of $45.2 million and ex-U.S. net sales of $16.3 million in the prior year quarter.

Selected Third Quarter 2020 Financial Results

Revenues

We recognized $79.5 million in total revenue in the third quarter of 2020, as compared to $61.9 million in total revenue in the prior year quarter. Total revenue in the third quarter of 2019 included approximately $0.4 million of licensing revenue.

Operating Expenses

Our cost of sales was $1.8 million in the third quarter of 2020, as compared to $0.5 million in the prior year quarter. Our cost of sales for the quarters ended September 30, 2020 and 2019 consisted primarily of packaging, labeling, materials and related expenses.

Our selling, general and administrative expenses decreased to $70.6 million in the third quarter of 2020, from $76.8 million in the prior year quarter. The decrease was primarily driven by reductions in spend resulting from the delay of the potential approval and commercialization of obeticholic acid (OCA) for liver fibrosis due to nonalcoholic steatohepatitis (NASH).

Our research and development expenses decreased to $48.9 million in the third quarter of 2020, from $60.2 million in the prior year quarter. The decrease was primarily driven by lower NASH development costs, including the conclusion of enrollment activities for the REGENERATE and REVERSE studies and reduced costs related to our preparations for regulatory interactions.

Restructuring expenses were $13.4 million and $0 for the three months ended September 30, 2020 and 2019, respectively. The increase between periods was driven primarily by severance costs and other related termination benefits incurred in conjunction with the previously announced plan to reduce workforce in response to the receipt of the complete response letter.

In the quarters ended September 30, 2020 and 2019, we recorded $134.7 million and $137.5 million, respectively, in total operating expenses and $118.1 million and $123.4 million, respectively, in non-GAAP adjusted operating expenses, which excludes non-cash stock-based compensation expense of $15.8 million and $13.1 million, respectively, and depreciation expense of $0.7 million and $0.9 million, respectively.

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

Interest Expense

Interest expense in the quarters ended September 30, 2020 and 2019 was $12.1 million and $11.8 million, respectively. For the quarter ended September 30, 2020, interest expense related to the $460.0 million aggregate principal amount of 3.25% Convertible Senior Notes due 2023 that we issued in July 2016 and the $230.0 million aggregate principal amount of 2.00% Convertible Senior Notes due 2026 (the “2026 Convertible Notes”) that we issued in May 2019.

Net Loss

In the third quarter of 2020 we reported a net loss of $66.5 million, a decrease compared to a net loss of $84.8 million in the third quarter 2019.

Cash Position

As of September 30, 2020, we had cash, cash equivalents, restricted cash, and investment debt securities available for sale of approximately $496.8 million. As of December 31, 2019, we had cash, cash equivalents, restricted cash, and investment debt securities available for sale of approximately $657.3 million.

2020 Financial Guidance

We are updating our 2020 Ocaliva net sales guidance to narrow the range at the upper end of our previously announced guidance, and now anticipate Ocaliva net sales of $310 million to $320 million. We are also updating our non-GAAP adjusted operating expenses guidance to narrow the range at the lower end of the previously announced guidance, and now anticipate non-GAAP adjusted operating expenses of $460 million to $480 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.

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.