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Intercept (ICPT) Q1 Earnings Miss Estimates, Revenues Up Y/Y
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Intercept incurred a loss of 77 cents per share (from continuing operations) in first-quarter 2023, wider than the Zacks Consensus Estimate and our model estimates of 57 cents and 58 cents, respectively. The company also reported a loss of $1.13 per share in the year-ago quarter.
Total revenues were $68 million, up 15% year over year. The top line missed the Zacks Consensus Estimate and our model estimate of $73.27 million and $69.4 million, respectively.
In the year-to-date period, the stock gained 29.1% against the industry’s decline of 6.6%.
Image Source: Zacks Investment Research
Quarter in Detail
Total revenues comprised of only Ocaliva (obeticholic acid or OCA) net sales in the United States.
OCA is approved under the brand name Ocaliva. It is used 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 license from the European Commission.
Selling, general and administrative expenses increased to $57.7 million from $37.8 million in the prior-year quarter. The increase was primarily driven by investment in non-alcoholic steatohepatitis (NASH) launch preparation and cost of abbreviated new drug application (ANDA) litigation, which was settled prior to trial.
Research and development expenses decreased to $41.7 million from $47.6 million in the year-ago quarter. This was due to lower NASH costs and cost-sharing reimbursements.
As of Mar 31, 2023, Intercept had cash, cash equivalents, restricted cash and marketable securities worth $435.2 million compared with $490.9 million as of Dec 31, 2022.
Other Updates
In March, Intercept announced the advisory meeting date by the Gastrointestinal Drugs Advisory Committee of the FDA to review its new drug application (NDA) seeking approval of OCA in pre-cirrhotic liver fibrosis due to NASH. The meeting is scheduled for May 19, 2023, and the target action date is set for Jun 22, 2023.
The company has an ongoing phase IIa FRESH (FXR Effect on Severe Alcohol-Associated Hepatitis) study, which is aimed at evaluating the safety, tolerability, efficacy and pharmacokinetics of INT-787 in patients with severe alcohol-associated hepatitis sAH.
Intercept is in the process of compiling data from the post-marketing phase IV COBALT study. The company plans to submit data from this study to the FDA later this year to support the continued approval of Ocalvia for the PBC indication.
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 hands at successfully developing a treatment for the abovementioned 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.
Intercept Pharmaceuticals, Inc. Price and Consensus
The Zacks Consensus Estimate for Ligand Pharmaceuticals' earnings per share has moved up from $3.30 to $4.16 for 2023 and from $3.10 to $4.58 for 2024, in the past 60 days. The stock has risen 15.6% in the year-to-date period.
Ligand Pharmaceuticals’ earnings missed estimates in three of the trailing four quarters and beat the same once, the average negative surprise being 10.07%. In the last reported quarter, LGND’s earnings beat estimates by 10.57%.
The loss per share estimate for Ocuphire Pharma has narrowed from 29 cents to 24 cents for 2023 and from 86 cents to 81 cents for 2024, in the past 60 days. The stock has risen 49.3% in the year-to-date period.
Ocuphire Pharma’s earnings beat estimates in three of the trailing four quarters and missed the same once, the average surprise being 23.85%. In the last reported quarter, OCUP’s earnings beat estimates by 42.35%.
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Intercept (ICPT) Q1 Earnings Miss Estimates, Revenues Up Y/Y
Intercept incurred a loss of 77 cents per share (from continuing operations) in first-quarter 2023, wider than the Zacks Consensus Estimate and our model estimates of 57 cents and 58 cents, respectively. The company also reported a loss of $1.13 per share in the year-ago quarter.
Total revenues were $68 million, up 15% year over year. The top line missed the Zacks Consensus Estimate and our model estimate of $73.27 million and $69.4 million, respectively.
In the year-to-date period, the stock gained 29.1% against the industry’s decline of 6.6%.
Image Source: Zacks Investment Research
Quarter in Detail
Total revenues comprised of only Ocaliva (obeticholic acid or OCA) net sales in the United States.
OCA is approved under the brand name Ocaliva. It is used 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 license from the European Commission.
Selling, general and administrative expenses increased to $57.7 million from $37.8 million in the prior-year quarter. The increase was primarily driven by investment in non-alcoholic steatohepatitis (NASH) launch preparation and cost of abbreviated new drug application (ANDA) litigation, which was settled prior to trial.
Research and development expenses decreased to $41.7 million from $47.6 million in the year-ago quarter. This was due to lower NASH costs and cost-sharing reimbursements.
As of Mar 31, 2023, Intercept had cash, cash equivalents, restricted cash and marketable securities worth $435.2 million compared with $490.9 million as of Dec 31, 2022.
Other Updates
In March, Intercept announced the advisory meeting date by the Gastrointestinal Drugs Advisory Committee of the FDA to review its new drug application (NDA) seeking approval of OCA in pre-cirrhotic liver fibrosis due to NASH. The meeting is scheduled for May 19, 2023, and the target action date is set for Jun 22, 2023.
The company has an ongoing phase IIa FRESH (FXR Effect on Severe Alcohol-Associated Hepatitis) study, which is aimed at evaluating the safety, tolerability, efficacy and pharmacokinetics of INT-787 in patients with severe alcohol-associated hepatitis sAH.
Intercept is in the process of compiling data from the post-marketing phase IV COBALT study. The company plans to submit data from this study to the FDA later this year to support the continued approval of Ocalvia for the PBC indication.
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 hands at successfully developing a treatment for the abovementioned 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.
Intercept Pharmaceuticals, Inc. Price and Consensus
Intercept Pharmaceuticals, Inc. price-consensus-chart | Intercept Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Currently, Intercept has a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the overall healthcare sector are Ligand Pharmaceuticals and Ocuphire Pharma (OCUP - Free Report) , both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for Ligand Pharmaceuticals' earnings per share has moved up from $3.30 to $4.16 for 2023 and from $3.10 to $4.58 for 2024, in the past 60 days. The stock has risen 15.6% in the year-to-date period.
Ligand Pharmaceuticals’ earnings missed estimates in three of the trailing four quarters and beat the same once, the average negative surprise being 10.07%. In the last reported quarter, LGND’s earnings beat estimates by 10.57%.
The loss per share estimate for Ocuphire Pharma has narrowed from 29 cents to 24 cents for 2023 and from 86 cents to 81 cents for 2024, in the past 60 days. The stock has risen 49.3% in the year-to-date period.
Ocuphire Pharma’s earnings beat estimates in three of the trailing four quarters and missed the same once, the average surprise being 23.85%. In the last reported quarter, OCUP’s earnings beat estimates by 42.35%.