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Shares of Intercept Pharmaceuticals, Inc. rose 3.89% on Mar 2 after the company reported results for the fourth quarter of 2022.
Intercept incurred a loss of 42 cents per share (from continuing operations) in fourth-quarter 2022, narrower than the Zacks Consensus Estimate of 53 cents. In the year-ago quarter, the company had reported a loss of $1.51 per share.
Total revenues were $77.2 million, which surpassed the Zacks Consensus Estimate by 0.42% and were up from $68.6 million in the year-ago quarter.
Intercept’s shares have gained 45.9% in the past year against the industry’s decline of 8.5%.
Image Source: Zacks Investment Research
Quarter in Detail
Total revenues generated in the quarter comprised only Ocaliva (obeticholic acid or OCA) net sales 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 FDA approval for Ocaliva was 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 increased to $55.4 million from $46.3 million in the prior-year quarter. The increase was primarily driven by investment in NASH launch preparation.
Research and development expenses decreased to $40.7 million from $51.1 million in the year-ago quarter due to lower non-alcoholic steatohepatitis (NASH) costs and cost-sharing reimbursements from Advanz.
As of Dec 31, 2022, Intercept had cash, cash equivalents, restricted cash and marketable securities worth $490.9 million.
2022 Results
Revenues in 2022 were $285.7 million, up from $260.7 million in 2021. But the same missed the Zacks Consensus Estimate of $343 million. Loss per share was $5.17 compared with $4.28 in 2021, whereas the Zacks Consensus Estimate was pegged at a loss of $7 per share.
Intercept Pharmaceuticals, Inc. Price and EPS Surprise
ICPT expects net sales between $310 million and $340 million.
Other Updates
In January 2023, the FDA accepted the company’s new drug application (NDA) for OCA in pre-cirrhotic liver fibrosis due to NASH. The FDA assigned a target action date of Jun 22, 2023, for the application. Intercept anticipates an advisory committee meeting as part of the FDA review process; however, the date has not yet been confirmed. The NDA included two positive 18-month interim analyses from the phase III REGENERATE study and a robust safety assessment of 2,477 patients, with nearly 1,000 on the study drug for four years.
In November 2022, Intercept announced severe alcohol-associated hepatitis (sAH) as the lead indication for the company's next-generation FXR agonist, INT-787. The company also initiated the phase IIa FRESH (FXR Effect on Severe Alcohol-Associated Hepatitis) study, which evaluated the safety, tolerability, efficacy and pharmacokinetics of INT-787 in patients with sAH.
Intercept is 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 the PBC indication.
Intercept has fully resolved the patent infringement case in the United States District Court for the District of Delaware that was scheduled for trial on Feb 27, 2023, and the case has been terminated by the Court. Similar patent litigation previously disclosed by the company against another ANDA filer seeking approval to market generic Ocaliva remains pending, with a trial scheduled for Jul 22, 2024.
Our Take
The successful development of OCA for NASH will give a significant boost to Intercept.
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 condition.
Another company, Viking Therapeutics (VKTX - Free Report) , is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. Viking initiated the VOYAGE study, a phase IIb study designed to evaluate VK2809 in patients with NASH and fibrosis.
Zacks Rank and Stocks to Consider
Intercept currently carries a Zacks Rank #3 (Hold).
AMRN’s loss estimates narrowed by 2 cents to 4 cents for 2023 and by 5 cents to 10 cents for 2024 in the past 60 days. Amarin surpassed earnings estimates in two of the trailing four quarters and missed in the remaining two, the average negative earnings surprise being 14.29%.
GERN’s loss estimates for 2022 have been flat at 38 cents but have narrowed by 2 cents to 36 cents for 2023 in the past 60 days. Geron surpassed earnings estimates in two of the trailing four quarters and missed in the remaining two, the average earnings surprise being 1.07%.
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Intercept (ICPT) Q4 Earnings Beat, Ocaliva Sales Increase
Shares of Intercept Pharmaceuticals, Inc. rose 3.89% on Mar 2 after the company reported results for the fourth quarter of 2022.
Intercept incurred a loss of 42 cents per share (from continuing operations) in fourth-quarter 2022, narrower than the Zacks Consensus Estimate of 53 cents. In the year-ago quarter, the company had reported a loss of $1.51 per share.
Total revenues were $77.2 million, which surpassed the Zacks Consensus Estimate by 0.42% and were up from $68.6 million in the year-ago quarter.
Intercept’s shares have gained 45.9% in the past year against the industry’s decline of 8.5%.
Image Source: Zacks Investment Research
Quarter in Detail
Total revenues generated in the quarter comprised only Ocaliva (obeticholic acid or OCA) net sales 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 FDA approval for Ocaliva was 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 increased to $55.4 million from $46.3 million in the prior-year quarter. The increase was primarily driven by investment in NASH launch preparation.
Research and development expenses decreased to $40.7 million from $51.1 million in the year-ago quarter due to lower non-alcoholic steatohepatitis (NASH) costs and cost-sharing reimbursements from Advanz.
As of Dec 31, 2022, Intercept had cash, cash equivalents, restricted cash and marketable securities worth $490.9 million.
2022 Results
Revenues in 2022 were $285.7 million, up from $260.7 million in 2021. But the same missed the Zacks Consensus Estimate of $343 million. Loss per share was $5.17 compared with $4.28 in 2021, whereas the Zacks Consensus Estimate was pegged at a loss of $7 per share.
Intercept Pharmaceuticals, Inc. Price and EPS Surprise
Intercept Pharmaceuticals, Inc. price-eps-surprise | Intercept Pharmaceuticals, Inc. Quote
Guidance Update
ICPT expects net sales between $310 million and $340 million.
Other Updates
In January 2023, the FDA accepted the company’s new drug application (NDA) for OCA in pre-cirrhotic liver fibrosis due to NASH. The FDA assigned a target action date of Jun 22, 2023, for the application. Intercept anticipates an advisory committee meeting as part of the FDA review process; however, the date has not yet been confirmed. The NDA included two positive 18-month interim analyses from the phase III REGENERATE study and a robust safety assessment of 2,477 patients, with nearly 1,000 on the study drug for four years.
In November 2022, Intercept announced severe alcohol-associated hepatitis (sAH) as the lead indication for the company's next-generation FXR agonist, INT-787. The company also initiated the phase IIa FRESH (FXR Effect on Severe Alcohol-Associated Hepatitis) study, which evaluated the safety, tolerability, efficacy and pharmacokinetics of INT-787 in patients with sAH.
Intercept is 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 the PBC indication.
Intercept has fully resolved the patent infringement case in the United States District Court for the District of Delaware that was scheduled for trial on Feb 27, 2023, and the case has been terminated by the Court. Similar patent litigation previously disclosed by the company against another ANDA filer seeking approval to market generic Ocaliva remains pending, with a trial scheduled for Jul 22, 2024.
Our Take
The successful development of OCA for NASH will give a significant boost to Intercept.
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 condition.
Another company, Viking Therapeutics (VKTX - Free Report) , is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. Viking initiated the VOYAGE study, a phase IIb study designed to evaluate VK2809 in patients with NASH and fibrosis.
Zacks Rank and Stocks to Consider
Intercept currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the biotech sector are Amarin (AMRN - Free Report) and Geron (GERN - Free Report) , both currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
AMRN’s loss estimates narrowed by 2 cents to 4 cents for 2023 and by 5 cents to 10 cents for 2024 in the past 60 days. Amarin surpassed earnings estimates in two of the trailing four quarters and missed in the remaining two, the average negative earnings surprise being 14.29%.
GERN’s loss estimates for 2022 have been flat at 38 cents but have narrowed by 2 cents to 36 cents for 2023 in the past 60 days. Geron surpassed earnings estimates in two of the trailing four quarters and missed in the remaining two, the average earnings surprise being 1.07%.