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Intercept (ICPT) Q4 Earnings & Sales Beat, Ocaliva in Focus
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Intercept Pharmaceuticals, Inc. incurred a loss of $1.23 per share in fourth-quarter 2021, narrower than the Zacks Consensus Estimate of a loss of $1.26 and the year-ago quarter’s loss of $1.58.
Total revenues of $92.4 million in the quarter beat the Zacks Consensus Estimate by 0.56% and increased from $83.3 million in the year-ago quarter.
Intercept shares have lost 16.2% in the past three months compared with the industry’s decline of 14.5%.
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 $68.7 million in the United States and $23.7 million outside the country.
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.
Research and development expenses decreased to $51.7 million from $51.9 million in the year-ago quarter, primarily driven by a reduction in costs associated with non-alcoholic steatohepatitis (NASH) development activities.
Selling, general and administrative expenses decreased to $60.6 million from $70.0 million in the prior-year quarter. The decline was primarily driven by reductions from the September 2020 restructuring activities, including a decrease in activities associated with the potential approval and commercialization of OCA for liver fibrosis due to NASH.
As of Dec 31, 2021, Intercept had cash, cash equivalents, restricted cash and marketable securities of $429.4 million.
2021 Results
Revenues increased to $363.5 million from $312.7 million in 2020. Loss per share was $2.87 compared with $8.34 in 2020.
Ocaliva net sales were $260.8 million in the country and ex-U.S. net sales totaled $102.7 million.
2022 Guidance
Ocaliva net sales are projected between $375 million and $405 million.
Other Updates
The prescribing information for lead drug, Ocaliva, in the United States has been updated. The update to the prescribing information was prompted by cases submitted to the FDA’s Adverse Event Reporting System and published in the medical literature. These were cases of worsening of liver problems or liver failure in PBC patients with cirrhosis treated with Ocaliva.
Consequently, the Boxed Warning has been updated. Ocaliva is now contraindicated for patients with PBC and decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis with evidence of portal.
The company is on track to compile a new data package from the phase III REGENERATE study in fibrosis due to NASH to support a potential resubmission meeting with the FDA in the first half of 2022.
Intercept expects to report top-line results from the phase III REVERSE study, a late-stage study in compensated cirrhosis due to NASH, in the third quarter.
Intercept Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
The lower-than-expected loss in the fourth quarter was encouraging, driven by strong double-digit revenue growth for Ocaliva, despite the challenges associated with the pandemic and the U.S. label update.
While the NASH market promises potential, it is quite challenging as well. Another company, Viking Therapeutics (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 and report initial data on the primary endpoint by the end of 2022.
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Intercept (ICPT) Q4 Earnings & Sales Beat, Ocaliva in Focus
Intercept Pharmaceuticals, Inc. incurred a loss of $1.23 per share in fourth-quarter 2021, narrower than the Zacks Consensus Estimate of a loss of $1.26 and the year-ago quarter’s loss of $1.58.
Total revenues of $92.4 million in the quarter beat the Zacks Consensus Estimate by 0.56% and increased from $83.3 million in the year-ago quarter.
Intercept shares have lost 16.2% in the past three months compared with the industry’s decline of 14.5%.
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 $68.7 million in the United States and $23.7 million outside the country.
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.
Research and development expenses decreased to $51.7 million from $51.9 million in the year-ago quarter, primarily driven by a reduction in costs associated with non-alcoholic steatohepatitis (NASH) development activities.
Selling, general and administrative expenses decreased to $60.6 million from $70.0 million in the prior-year quarter. The decline was primarily driven by reductions from the September 2020 restructuring activities, including a decrease in activities associated with the potential approval and commercialization of OCA for liver fibrosis due to NASH.
As of Dec 31, 2021, Intercept had cash, cash equivalents, restricted cash and marketable securities of $429.4 million.
2021 Results
Revenues increased to $363.5 million from $312.7 million in 2020. Loss per share was $2.87 compared with $8.34 in 2020.
Ocaliva net sales were $260.8 million in the country and ex-U.S. net sales totaled $102.7 million.
2022 Guidance
Ocaliva net sales are projected between $375 million and $405 million.
Other Updates
The prescribing information for lead drug, Ocaliva, in the United States has been updated. The update to the prescribing information was prompted by cases submitted to the FDA’s Adverse Event Reporting System and published in the medical literature. These were cases of worsening of liver problems or liver failure in PBC patients with cirrhosis treated with Ocaliva.
Consequently, the Boxed Warning has been updated. Ocaliva is now contraindicated for patients with PBC and decompensated cirrhosis, a prior decompensation event, or with compensated cirrhosis with evidence of portal.
The company is on track to compile a new data package from the phase III REGENERATE study in fibrosis due to NASH to support a potential resubmission meeting with the FDA in the first half of 2022.
Intercept expects to report top-line results from the phase III REVERSE study, a late-stage study in compensated cirrhosis due to NASH, in the third quarter.
Intercept Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Intercept Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Intercept Pharmaceuticals, Inc. Quote
Our Take
The lower-than-expected loss in the fourth quarter was encouraging, driven by strong double-digit revenue growth for Ocaliva, despite the challenges associated with the pandemic and the U.S. label update.
While the NASH market promises potential, it is quite challenging as well. Another company, Viking Therapeutics (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 and report initial data on the primary endpoint by the end of 2022.
Intercept currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the sector are Axsome Therapeutics, Inc. (AXSM - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Axsome Therapeutics’ loss per share estimates have narrowed to $3.64 from $3.66 for 2022 over the past 60 days.
Earnings of Axsome Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.
Vertex’ Pharmaceuticals earnings per share estimates have increased to $15.31 from $13.85 for 2022 over the past 60 days.
The consensus estimate for 2022 earnings for Vertex has increased $1.01 over the past 30 days to $14.33. Shares of VRTX gained 9.4% in the past year.