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Intercept (ICPT) Beats on Q3 Earnings & Sales, Ups View
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Intercept Pharmaceuticals, Inc. incurred a loss of 63 cents (excluding gain on extinguishment of debt) per share in third-quarter 2021, narrower than the Zacks Consensus Estimate of a loss of $1.00 and the year-ago quarter’s loss of $2.01.
Total revenues of $92.8 million in the quarter beat the Zacks Consensus Estimate of $83 million and also increased from $79.5 million in the year-ago quarter.
Shares of the company were up following the results. However, the stock has slumped 21.8% in the year so far compared with the industry’s decline of 8.2%.
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 $66.6 million in the United States and $26.2 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 $45 million from $48.9 million in the year-ago quarter, primarily driven by lower personnel and development costs.
Selling, general and administrative expenses decreased to $53.3 million from $70.6 million in the year-ago quarter. The decline was driven by actions taken to decrease expenses relating to the launch preparation activities associated with the potential approval and commercialization of OCA for liver fibrosis due to non-alcoholic steatohepatitis (NASH) following the complete response letter, which was received in 2020.
As of Sep 30, 2021, Intercept had cash, cash equivalents, restricted cash and marketable securities of $428.8 million.
2021 Guidance Upped
Ocaliva net sales are now projected between $355 million and $370 million (earlier guidance: $325 million to $340 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 and 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.
Our Take
The lower-than-expected loss in the third quarter was encouraging. The company’s effort to develop a treatment for NASH despite setbacks is positive.
Intercept Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
While the NASH market promises potential, it is quite challenging as well. Bigwigs like Novo Nordisk (NVO - Free Report) and Gilead Sciences, Inc. (GILD - Free Report) are also evaluating candidates for NASH. Another company, Viking Therapeutics (VKTX - Free Report) , is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis.
Image: Bigstock
Intercept (ICPT) Beats on Q3 Earnings & Sales, Ups View
Intercept Pharmaceuticals, Inc. incurred a loss of 63 cents (excluding gain on extinguishment of debt) per share in third-quarter 2021, narrower than the Zacks Consensus Estimate of a loss of $1.00 and the year-ago quarter’s loss of $2.01.
Total revenues of $92.8 million in the quarter beat the Zacks Consensus Estimate of $83 million and also increased from $79.5 million in the year-ago quarter.
Shares of the company were up following the results. However, the stock has slumped 21.8% in the year so far compared with the industry’s decline of 8.2%.
Quarter in Detail
Total revenues generated in the quarter comprised only Ocaliva (obeticholic acid or OCA) net sales. Net sales came in at $66.6 million in the United States and $26.2 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 $45 million from $48.9 million in the year-ago quarter, primarily driven by lower personnel and development costs.
Selling, general and administrative expenses decreased to $53.3 million from $70.6 million in the year-ago quarter. The decline was driven by actions taken to decrease expenses relating to the launch preparation activities associated with the potential approval and commercialization of OCA for liver fibrosis due to non-alcoholic steatohepatitis (NASH) following the complete response letter, which was received in 2020.
As of Sep 30, 2021, Intercept had cash, cash equivalents, restricted cash and marketable securities of $428.8 million.
2021 Guidance Upped
Ocaliva net sales are now projected between $355 million and $370 million (earlier guidance: $325 million to $340 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 and 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.
Our Take
The lower-than-expected loss in the third quarter was encouraging. The company’s effort to develop a treatment for NASH despite setbacks is positive.
Intercept Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
Intercept Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Intercept Pharmaceuticals, Inc. Quote
While the NASH market promises potential, it is quite challenging as well. Bigwigs like Novo Nordisk (NVO - Free Report) and Gilead Sciences, Inc. (GILD - Free Report) are also evaluating candidates for NASH. Another company, Viking Therapeutics (VKTX - Free Report) , is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis.
Intercept currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.