NEW YORK, Nov. 05, 2019 (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, 2019.

“During the third quarter, we submitted our NDA seeking accelerated approval of OCA for NASH in the U.S., a historic achievement for our company and a critically important milestone for the many patients currently without an approved treatment,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “With the submission behind us, we are actively preparing to launch the first therapy for advanced fibrosis due to NASH and our pre-launch disease state educational activities are accelerating with the continued expansion of our sales, medical and market access teams. In addition, we are looking forward to the presentation of important new data from the interim analysis of our ongoing Phase 3 REGENERATE study at the upcoming AASLD Liver Meeting. Based on our team’s strong commercial execution in the third quarter, I am also pleased to announce that we are increasing our 2019 net sales guidance for Ocaliva to between $245 million and $250 million.”

Ocaliva® (obeticholic acid) Commercial Highlights

We recognized $61.5 million of worldwide Ocaliva net sales in the third quarter of 2019, as compared to $46.6 million in the prior year quarter. Ocaliva net sales in the third quarter of 2019 were comprised of U.S. net sales of $45.2 million and ex-U.S. net sales of $16.3 million, as compared to U.S. net sales of $36.7 million and ex-U.S. net sales of $9.9 million in the prior year quarter.

Ocaliva was approved in the United States by the FDA in May 2016 and by the European Commission in December 2016 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. Since December 2016, Ocaliva has also received regulatory approval in several of our target markets outside the United States and Europe, including Canada, Israel and Australia.

Selected Third Quarter 2019 Financial Results

Revenues

We recognized $61.9 million in total revenue in the third quarter of 2019, as compared to $47.0 million in total revenue in the prior year quarter. Total revenue in the third quarter of 2019 included $61.5 million of Ocaliva net sales and approximately $0.4 million of licensing revenue, as compared to $46.6 million and approximately $0.4 million, respectively, in the prior year quarter.

Operating Expenses

Our cost of sales was $0.5 million in the third quarter of 2019, as compared to $0.5 million in the prior year quarter. Our cost of sales for the quarters ended September 30, 2019 and 2018 consisted primarily of packaging, labeling, materials and related expenses.

Our selling, general and administrative expenses increased to $76.8 million in the third quarter of 2019, up from $56.8 million in the prior year quarter. The increase was primarily driven by increases in launch preparation activities related to our lead product candidate, obeticholic acid (“OCA”), for the potential treatment of liver fibrosis due to NASH.

Our research and development expenses increased to $60.2 million in the third quarter of 2019, up from $47.9 million in the prior year quarter. The increase was primarily driven by increases in development program expenses relating to OCA for NASH and costs associated with the NDA submission.

In the quarters ended September 30, 2019 and 2018, we recorded $137.5 million and $105.3 million, respectively, in total operating expenses and $122.1 million and $92.2 million, respectively, in non-GAAP adjusted operating expenses, which excludes non-cash stock-based compensation expense of $13.1 million and $12.0 million, respectively, and depreciation and amortization expense of $2.2 million and $1.1 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 and amortization. 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, 2019 and 2018 was $11.8 million and $7.7 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 $230 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 2019, we reported a net loss of $84.8 million, up from a net loss of $64.5 million in the prior year quarter.

Cash Position

As of September 30, 2019, we had cash, cash equivalents and investment debt securities available for sale of approximately $712.4 million. As of December 31, 2018, we had cash, cash equivalents and investment debt securities available for sale of approximately $436.2 million.

2019 Financial Guidance

Based on our third quarter results and our current outlook for the remainder of 2019, we are increasing our 2019 Ocaliva net sales guidance range to between $245 million and $250 million, from $235 million to $245 million. In addition, we are narrowing our 2019 non-GAAP adjusted operating expenses guidance range to between $480 million and $500 million, from $470 million to $500 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.