We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Intercept's (ICPT) Q2 Earnings and Revenues Beat Estimates
Read MoreHide Full Article
Intercept Pharmaceuticals, Inc. incurred a loss of $1.92 per share in second-quarter 2020, narrower than the Zacks Consensus Estimate of a loss of $2.94 and the year-ago quarter’s loss of $2.28.
Total revenues of $77.2 million in the quarter beat the Zacks Consensus Estimate of $71.14 million. Revenues also surged 16.5% year over year, primarily owing to higher sales of lead drug, Ocaliva.
Quarter in Detail
The total revenues generated in the quarter comprised only Ocaliva (obeticholic acid or OCA) net sales. Net sales came in at $59.6 million in the United States and $17.6 million outside the country.
We remind investors that OCA is already 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 or as a monotherapy for adults intolerant to UDCA.
Ocaliva sales were driven by strong end-market demand and the company continues to see significant total prescription growth.
Research and development expenses decreased to $34 million from $59.6 million in the year-ago quarter due to lower nonalcoholic steatohepatitis (NASH) development program expenses and costs.
Selling, general and administrative expenses were $93.4 million, up from $69.7 million in the year-ago quarter, primarily driven by activities associated with the preparation for the potential approval and commercialization of OCA for liver fibrosis due to NASH.
As of Jun 30, 2020, Intercept had cash, cash equivalents, restricted cash and marketable securities of $540.6 million compared with $657.4 million as of Dec 31, 2019.
Other Updates
In June 2020, the FDA had issued a Complete Response Letter (CRL) regarding our New Drug Application (NDA) for OCA for the treatment of fibrosis due to NASH. As a result, the company does not expect to launch OCA for NASH in 2020.
The phase III REGENERATE and REVERSE studies have been fully enrolled.
Guidance
Ocaliva net sales are projected between $300 million and $320 million in 2020.
Our Take
Intercept reported better-than-expected results for the second quarter. The company’s efforts to expand Ocaliva’s label are encouraging as well, given the market potential of NASH.
However, the CRL for OCA was disappointing as Intercept’s OCA was a frontrunner in receiving approval for the treatment of NASH. Per the company, the FDA has progressively increased the complexity of the histologic endpoints, creating a very high bar that only OCA has so far met in a late-stage study.
A potential approval would have significantly boosted Intercept’s prospects, as OCA would have been one of the first therapies approved for the treatment of NASH.
Nevertheless, the company is preparing to meet the FDA to discuss the basis for resubmission of the NDA seeking accelerated approval of OCA for the treatment of advanced fibrosis due to NASH.
Shares of Intercept have slumped 57.4% in the year so far against the industry’s growth of 5.3%.
While the NASH market promises potential, it is quite challenging as well. France-based Genfit (GNFT - Free Report) announced disappointing results from an interim analysis of the RESOLVE-IT phase III study evaluating once-daily, 120mg of elafibranor in adults with NASH.
Meanwhile, Viking Therapeutics (VKTX - Free Report) is enrolling in the phase IIb VOYAGE study evaluating VK2809 in biopsy-confirmed NASH and fibrosis. Clinical-stage biopharmaceutical company, Galmed Pharmaceuticals Ltd. (GLMD - Free Report) , is also developing Aramchol, a liver targeted, oral SCD1 modulator for patients with NASH and fibrosis.
From thousands of stocks, 5 Zacks experts each picked their favorite to gain +100% or more in months to come. From those 5, Zacks Director of Research, Sheraz Mian hand-picks one to have the most explosive upside of all.
With users in 180 countries and soaring revenues, it’s set to thrive on remote working long after the pandemic ends. No wonder it recently offered a stunning $600 million stock buy-back plan.
The sky’s the limit for this emerging tech giant. And the earlier you get in, the greater your potential gain.
Image: Bigstock
Intercept's (ICPT) Q2 Earnings and Revenues Beat Estimates
Intercept Pharmaceuticals, Inc. incurred a loss of $1.92 per share in second-quarter 2020, narrower than the Zacks Consensus Estimate of a loss of $2.94 and the year-ago quarter’s loss of $2.28.
Total revenues of $77.2 million in the quarter beat the Zacks Consensus Estimate of $71.14 million. Revenues also surged 16.5% year over year, primarily owing to higher sales of lead drug, Ocaliva.
Quarter in Detail
The total revenues generated in the quarter comprised only Ocaliva (obeticholic acid or OCA) net sales. Net sales came in at $59.6 million in the United States and $17.6 million outside the country.
We remind investors that OCA is already 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 or as a monotherapy for adults intolerant to UDCA.
Ocaliva sales were driven by strong end-market demand and the company continues to see significant total prescription growth.
Research and development expenses decreased to $34 million from $59.6 million in the year-ago quarter due to lower nonalcoholic steatohepatitis (NASH) development program expenses and costs.
Selling, general and administrative expenses were $93.4 million, up from $69.7 million in the year-ago quarter, primarily driven by activities associated with the preparation for the potential approval and commercialization of OCA for liver fibrosis due to NASH.
As of Jun 30, 2020, Intercept had cash, cash equivalents, restricted cash and marketable securities of $540.6 million compared with $657.4 million as of Dec 31, 2019.
Other Updates
In June 2020, the FDA had issued a Complete Response Letter (CRL) regarding our New Drug Application (NDA) for OCA for the treatment of fibrosis due to NASH. As a result, the company does not expect to launch OCA for NASH in 2020.
The phase III REGENERATE and REVERSE studies have been fully enrolled.
Guidance
Ocaliva net sales are projected between $300 million and $320 million in 2020.
Our Take
Intercept reported better-than-expected results for the second quarter. The company’s efforts to expand Ocaliva’s label are encouraging as well, given the market potential of NASH.
However, the CRL for OCA was disappointing as Intercept’s OCA was a frontrunner in receiving approval for the treatment of NASH. Per the company, the FDA has progressively increased the complexity of the histologic endpoints, creating a very high bar that only OCA has so far met in a late-stage study.
A potential approval would have significantly boosted Intercept’s prospects, as OCA would have been one of the first therapies approved for the treatment of NASH.
Nevertheless, the company is preparing to meet the FDA to discuss the basis for resubmission of the NDA seeking accelerated approval of OCA for the treatment of advanced fibrosis due to NASH.
Shares of Intercept have slumped 57.4% in the year so far against the industry’s growth of 5.3%.
While the NASH market promises potential, it is quite challenging as well. France-based Genfit (GNFT - Free Report) announced disappointing results from an interim analysis of the RESOLVE-IT phase III study evaluating once-daily, 120mg of elafibranor in adults with NASH.
Meanwhile, Viking Therapeutics (VKTX - Free Report) is enrolling in the phase IIb VOYAGE study evaluating VK2809 in biopsy-confirmed NASH and fibrosis. Clinical-stage biopharmaceutical company, Galmed Pharmaceuticals Ltd. (GLMD - Free Report) , is also developing Aramchol, a liver targeted, oral SCD1 modulator for patients with 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.
Zacks’ Single Best Pick to Double
From thousands of stocks, 5 Zacks experts each picked their favorite to gain +100% or more in months to come. From those 5, Zacks Director of Research, Sheraz Mian hand-picks one to have the most explosive upside of all.
With users in 180 countries and soaring revenues, it’s set to thrive on remote working long after the pandemic ends. No wonder it recently offered a stunning $600 million stock buy-back plan.
The sky’s the limit for this emerging tech giant. And the earlier you get in, the greater your potential gain.
Click Here, See It Free >>