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.
Shares of Intercept Pharmaceuticals, Inc. rose 13.4% on Nov 1 after the company beat sales estimates for the third quarter of 2022 and raised its sales guidance for its lead drug, Ocaliva.
Intercept incurred a loss of $3.04 per share (from continuing operations) in third-quarter 2022 in contrast to the Zacks Consensus Estimate of earnings of $5.11 per share. In the year-ago quarter, the company had reported a loss of 53 cents per share.
The wider year-over-year net loss was due to the gain recognized on the sale of the ex-U.S. business, partially offset by a loss on the extinguishment of 2026 Convertible Secured Notes.
Total revenues came in at $77.59 million, which surpassed the Zacks Consensus Estimate of $76 million and were up from $66.6 million in the year-ago quarter.
Intercept’s shares have lost 3.5% in the year so far compared with the industry’s decline of 21.9%.
Image Source: Zacks Investment Research
Quarter in Detail
Total revenues generated in the quarter comprised only Ocaliva (obeticholic acid or OCA) net sales in the United States.
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. While the approval for Ocaliva was granted by the FDA under an accelerated pathway, the drug also received conditional approval from the European Commission.
On Jul 1, 2022, Intercept completed the sale of its international business for $405 million.
Selling, general and administrative expenses increased to $43.2 million from $41.2 million in the prior-year quarter. The increase was primarily due to commercial activities and costs related to litigation.
Research and development expenses decreased to $44 million from $44.7 million in the year-ago quarter.
As of Sep 30, 2022, Intercept had cash, cash equivalents, restricted cash and marketable securities of $497.8 million.
In August and September 2022, Intercept repurchased $388.9 million of 2026 Convertible Secured Notes for $258.2 million in cash and $219.4 million in equity for a total consideration of $477.6 million.
Guidance Update
ICPT now expects net sales between $340 million and $350 million compared with the previous guidance of $325 million to $345 million.
Other Updates
Based on the positive new interim analysis from its phase III REGENERATE study, Intercept is on track to resubmit its new drug application (NDA) for OCA in liver fibrosis due to non-alcoholic steatohepatitis (NASH) by the end of 2022.
However, the phase III REVERSE study in patients with compensated cirrhosis, due to NASH, did not meet its regulatory primary endpoint.
Intercept is currently in the process of compiling data from the post-marketing phase IV COBALT study. ICPT plans to submit data from this study to the FDA later this year to support the continued approval of Ocalvia for the PBC indication.
Intercept continues to add clinical sites and screen patients in its U.S.-based phase II OCA/bezafibrate fixed-dose combination trial in PBC.
The phase I study for its next-generation FXR agonist, INT-787, progressed to the final cohorts. Intercept looks forward to sharing data from its phase I studies, as well as a targeted indication and development plans for INT-787 later.
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 hand at successfully developing a treatment for the same condition.
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 in the fourth quarter of 2022 and report data for the primary endpoint in the first half of 2023.
Loss estimates for Puma have narrowed to 6 cents from 16 cents over the past 60 days. Puma surpassed estimates in three of the trailing four quarters and missed in the other one, the average being 201.37%.
Earnings estimates for Dynavax have increased to $1.74 from $1.15 for 2022 over the past 90 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Intercept (ICPT) Q3 Earnings Miss, Sales Beat, View Raised
Shares of Intercept Pharmaceuticals, Inc. rose 13.4% on Nov 1 after the company beat sales estimates for the third quarter of 2022 and raised its sales guidance for its lead drug, Ocaliva.
Intercept incurred a loss of $3.04 per share (from continuing operations) in third-quarter 2022 in contrast to the Zacks Consensus Estimate of earnings of $5.11 per share. In the year-ago quarter, the company had reported a loss of 53 cents per share.
The wider year-over-year net loss was due to the gain recognized on the sale of the ex-U.S. business, partially offset by a loss on the extinguishment of 2026 Convertible Secured Notes.
Total revenues came in at $77.59 million, which surpassed the Zacks Consensus Estimate of $76 million and were up from $66.6 million in the year-ago quarter.
Intercept’s shares have lost 3.5% in the year so far compared with the industry’s decline of 21.9%.
Image Source: Zacks Investment Research
Quarter in Detail
Total revenues generated in the quarter comprised only Ocaliva (obeticholic acid or OCA) net sales in the United States.
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. While the approval for Ocaliva was granted by the FDA under an accelerated pathway, the drug also received conditional approval from the European Commission.
On Jul 1, 2022, Intercept completed the sale of its international business for $405 million.
Selling, general and administrative expenses increased to $43.2 million from $41.2 million in the prior-year quarter. The increase was primarily due to commercial activities and costs related to litigation.
Research and development expenses decreased to $44 million from $44.7 million in the year-ago quarter.
As of Sep 30, 2022, Intercept had cash, cash equivalents, restricted cash and marketable securities of $497.8 million.
In August and September 2022, Intercept repurchased $388.9 million of 2026 Convertible Secured Notes for $258.2 million in cash and $219.4 million in equity for a total consideration of $477.6 million.
Guidance Update
ICPT now expects net sales between $340 million and $350 million compared with the previous guidance of $325 million to $345 million.
Other Updates
Based on the positive new interim analysis from its phase III REGENERATE study, Intercept is on track to resubmit its new drug application (NDA) for OCA in liver fibrosis due to non-alcoholic steatohepatitis (NASH) by the end of 2022.
However, the phase III REVERSE study in patients with compensated cirrhosis, due to NASH, did not meet its regulatory primary endpoint.
Intercept is currently in the process of compiling data from the post-marketing phase IV COBALT study. ICPT plans to submit data from this study to the FDA later this year to support the continued approval of Ocalvia for the PBC indication.
Intercept continues to add clinical sites and screen patients in its U.S.-based phase II OCA/bezafibrate fixed-dose combination trial in PBC.
The phase I study for its next-generation FXR agonist, INT-787, progressed to the final cohorts. Intercept looks forward to sharing data from its phase I studies, as well as a targeted indication and development plans for INT-787 later.
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 hand at successfully developing a treatment for the same condition.
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 in the fourth quarter of 2022 and report data for the primary endpoint in the first half of 2023.
Zacks Rank and Stocks to Consider
Intercept currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector are Puma Biotechnology (PBYI - Free Report) and Dynavax (DVAX - Free Report) . Both the stocks carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for Puma have narrowed to 6 cents from 16 cents over the past 60 days. Puma surpassed estimates in three of the trailing four quarters and missed in the other one, the average being 201.37%.
Earnings estimates for Dynavax have increased to $1.74 from $1.15 for 2022 over the past 90 days. Earnings of Dynavax surpassed estimates in two of the trailing four quarters.