Intercept Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Business Update.

ENPNewswire-November 1, 2018--Intercept Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Business Update

(C)2018 ENPublishing - http://www.enpublishing.co.uk

Release date- 31102018 - NEW YORK - 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, 2018.

'2018 has been an important year for Intercept as we have continued to make progress executing against our key strategic priorities in our Phase 3 NASH program and our PBC commercial efforts,' said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. 'We remain on track to report top line data from the Phase 3 REGENERATE trial in the first half of 2019. We have also continued to advance our efforts to bring Ocaliva to eligible PBC patients in need and believe that we are well positioned to drive growth and capitalize on this sizeable market opportunity.'

Ocaliva (obeticholic acid or OCA) Commercial Highlights

We recorded $46.6 million of Ocaliva net sales in the third quarter of 2018, as compared to $40.9 millionin the prior year quarter. Ocaliva net sales in the third quarter of 2018 were comprised of U.S. net sales of $36.7 million and ex-U.S. net sales of $9.9 million, as compared to U.S. net sales of $36.2 million and ex-U.S. net sales of $4.7 million in the prior year quarter.

Ocaliva was approved in the United States by the U.S. Food and Drug Administration ('FDA') in May 2016for 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. We commenced sales and marketing of Ocaliva in the United States shortly after receiving marketing approval, and Ocaliva is now available to patients primarily through a network of specialty pharmacy distributors.

Ocaliva was granted conditional approval by the European Commission in December 2016 for the treatment of PBC in combination with UDCA in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA, and we commenced our European commercial launch in January 2017. Since January 2017, 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 2018 Financial Results

Revenues

We recognized $47.0 million in total revenue in the quarter ended September 30, 2018, up from $41.3 million in total revenue in the quarter ended September 30, 2017. Total revenue in the third quarter of 2018 included $46.6 million of Ocaliva net sales and approximately $0.4 million of licensing revenue related to the amortization of upfront payments under our license agreement with Sumitomo Dainippon Pharma Co., Ltd., as compared to $40.9 million and approximately $0.4 million, respectively, in the prior year quarter. Included in total revenue in the third quarter of 2017 is $4.1 million of previously deferred revenue recognized in connection with our adoption of a sell-in basis revenue recognition policy in such quarter.

Operating Expenses

Our cost of sales was $0.5 million in the third quarter of 2018, as compared to $0.2 million in the prior year quarter. Prior to the FDA's approval of Ocaliva, we expensed costs related to the manufacturing and buildup of our Ocaliva commercial launch supplies. As a result, our cost of sales in the quarters ended September 30, 2018 and 2017 consisted primarily of packaging and labeling expenses.

Our selling, general and administrative expenses decreased to $56.8 million in the quarter ended September 30, 2018, down from $61.4 million in the prior year quarter. The decrease was primarily driven by a decrease in consultant spend and personnel-related costs.

Research and development expenses increased to $47.9 million in the quarter ended September 30, 2018, up from $46.0 million in the prior year quarter. The increase was primarily driven by an increase in OCA research and development activities and other costs.

In the quarters ended September 30, 2018 and 2017, we recorded $105.3 million and $107.5 million, respectively, in total operating expenses and $92.2 million and $92.9 million, respectively, in non-GAAP adjusted operating expenses, which excludes non-cash stock-based compensation expense of $12.0 million and $13.2 million, respectively, and depreciation expense...

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