It has been about a month since the last earnings report for Intercept Pharmaceuticals . Shares have added about 15.4% in that time frame, outperforming the S&P 500.
Will the recent positive trend continue leading up to its next earnings release, or is Intercept due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers.
Intercept Q4 Earnings & Sales Beat, Ocaliva in Focus
Intercept 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.
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.
How Have Estimates Been Moving Since Then?
Analysts were quiet during the last two month period as none of them issued any earnings estimate revisions.
The consensus estimate has shifted 8.14% due to these changes.
VGM Scores
At this time, Intercept has a strong Growth Score of A, a grade with the same score on the momentum front. Charting a somewhat similar path, the stock was allocated a grade of B on the value side, putting it in the second quintile for this investment strategy.
Overall, the stock has an aggregate VGM Score of A. If you aren't focused on one strategy, this score is the one you should be interested in.
Outlook
Intercept has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.
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Intercept (ICPT) Up 15.4% Since Last Earnings Report: Can It Continue?
It has been about a month since the last earnings report for Intercept Pharmaceuticals . Shares have added about 15.4% in that time frame, outperforming the S&P 500.
Will the recent positive trend continue leading up to its next earnings release, or is Intercept due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers.
Intercept Q4 Earnings & Sales Beat, Ocaliva in Focus
Intercept 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.
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.
How Have Estimates Been Moving Since Then?
Analysts were quiet during the last two month period as none of them issued any earnings estimate revisions.
The consensus estimate has shifted 8.14% due to these changes.
VGM Scores
At this time, Intercept has a strong Growth Score of A, a grade with the same score on the momentum front. Charting a somewhat similar path, the stock was allocated a grade of B on the value side, putting it in the second quintile for this investment strategy.
Overall, the stock has an aggregate VGM Score of A. If you aren't focused on one strategy, this score is the one you should be interested in.
Outlook
Intercept has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months.