Intercept Pharmaceuticals, Inc. ( ICPT Quick Quote ICPT - Free Report) incurred a loss of 68 cents per share (from continuing operations) in second-quarter 2022, wider than the Zacks Consensus Estimate of a loss of 53 cents.
Total revenues came in at $100.4 million, which surpassed the Zacks Consensus Estimate of $95 million.
Intercept’s shares have lost 15.1% in the year so far compared with the industry’s decrease of 22.1%. Shares jumped 12.98% following the quarterly results. Image Source: Zacks Investment Research Quarter in Detail
Total revenues generated in the quarter comprised only Ocaliva (obeticholic acid or OCA) net sales. Net sales came in at $71.8 million in the United States.
OCA is approved under the brand name Ocaliva for treating primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA alone or as a monotherapy for adults intolerant to UDCA. While the approval for Ocaliva was granted by the FDA under an accelerated pathway, the drug received conditional approval from the European Commission.
On Jul 1, 2022, Intercept completed the sale of its international business for $405 million.
Selling, general and administrative expenses decreased to $40.0 million from $43.9 million in the prior-year quarter. The decline was primarily due to ICPT’s ongoing efforts to manage its operational costs.
Research and development expenses increased to $44.8 million from $37.7 million in the year-ago quarter.
As of Jun 30, 2022, Intercept had cash, cash equivalents, restricted cash and marketable securities of $412.3 million.
The company has reissued guidance which was previously suspended due to the impact and lack of clarity on the timing for closing the sale of its international business. ICPT now expects net sales between $325 million and $345 million compared with the previous guidance of $375 million to $405 million.
Intercept is currently in the process of compiling data from the post-marketing phase IV COBALT study. ICPT plans to submit data from this study to the FDA later this year to support the continued approval of Ocalvia for PBC indication.
Intercept continues to add clinical sites and screen patients in its U.S.-based phase II OCA/bezafibrate fixed-dose combination trial in PBC and keeps enrolling patients in its phase II OCA/bezafibrate fixed-dose combination trial in Europe. The phase I study of this combination in the United States has completed enrollment.
Last month, Intercept had a pre-submission meeting with FDA in July. It plans to resubmit its new drug application (NDA) for OCA in fibrosis due to nonalcoholic Steatohepatitis (NASH) by the end of 2022.
Top-line readout from the phase III REVERSE study in patients with compensated cirrhosis due to NASH is expected late in the ongoing quarter. This is a separate investigational new drug (IND) application in fibrosis due to NASH.
The phase I study for its next-generation FXR agonist, INT-787, has progressed to the final cohorts. Intercept looks forward to sharing data from its phase 1 studies, as well as a targeted indication and development plans for INT-787 later this year.
While the NASH market promises potential with no approved therapies yet, it is challenging.
Quite a few players are trying their hand at successfully developing a treatment for the same.
Viking Therapeutics ( VKTX Quick Quote VKTX - Free Report) , is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. VK2809 is currently being evaluated in a phase IIb study in patients with NASH. Viking expects to complete enrollment in the second half of 2022. Pfizer ( PFE Quick Quote PFE - Free Report) recently announced that the FDA has granted Fast Track designation to its investigational combination therapy for treating NASH with liver fibrosis.
The investigational therapy comprises ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi). Pfizer is currently studying the combination in an ongoing phase II study evaluating the impact of treatment on the resolution of NASH or improvement in liver fibrosis, expected to complete in 2024.
Zacks Stock and Stocks to Consider
Intercept currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the sector is
Alkermes ( ALKS Quick Quote ALKS - Free Report) carrying a Zacks Rank #2 (Buy) at present. You can see . the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
ALKS’ earnings estimates for 2022 reversed from a loss of 14 cents to earnings of 20 cents in the past seven days. Alkermes surpassed earnings in all the trailing four quarters, the average being 325.48%
(We are reissuing this article to correct a mistake. The original article, issued on August 04, 2022, should no longer be relied upon.)