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.
Intra-Cellular (ITCI) Q1 Earnings and Sales Beat Estimates
Read MoreHide Full Article
Intra-Cellular Therapies, Inc. (ITCI - Free Report) reported first-quarter 2024 loss of 16 cents per share, narrower than the Zacks Consensus Estimate of a loss of 31 cents, primarily due to higher product sales. The company had incurred a loss of 46 cents per share in the year-ago quarter.
Total revenues, comprising product sales and grant revenues, came in at $144.9 million compared with $95.3 million reported in the year-ago period. The top line beat the Zacks Consensus Estimate of $141.9 million.
Quarter in Detail
Caplyta, the only approved drug in Intra-Cellular’s portfolio, was approved by the FDA in December 2019, for treating schizophrenia in adults. The drug also received the FDA’s approval for treating bipolar depression in December 2021. Post this approval, Caplyta sales have increased tremendously.
Net product revenues, comprising Caplyta sales, were up 53% year over year to $144.8 million on the back of strong prescription uptake.
Per Intra-Cellular, Caplyta prescriptions jumped 39% year over year, despite typical first-quarter seasonal dynamics as well as industry disruption.
Research and development (R&D) expenses climbed 13% to $42.8 million from the year-ago quarter’s figure. This uptick was due to higher lumateperone program costs.
Selling, general and administrative (SG&A) expenses increased 14% year over year to $113.1 million, driven by marketing and advertising costs.
Year to date, shares of the company have lost 0.6% compared with the industry’s 6.2% decline.
Image Source: Zacks Investment Research
As of Mar 31, 2024, ITCI had cash, cash equivalents, restricted cash and investment securities of $477.4 million compared with $499.7 million as of Dec 31, 2023.
2024 Financial Outlook Reaffirmed
Intra-Cellular reiterated its previously announced financial guidance for 2024. It expects Caplyta net product sales in the range of $645-$675 million.
R&D expenses are expected in the band of $215-$240 million.
SG&A expenses are anticipated between $450 million and $480 million.
Key Pipeline Updates
Last month, Intra-Cellular announced positive top-line results from its late-stage study evaluating lumateperone 42 mg for the treatment of major depressive disorder (MDD). Statistically significant efficacy upon treatment of MDD patients with lumateperone 42 mg was observed as early as after one week of dosing, which was maintained throughout the study in the primary and key secondary endpoints.
A second phase III study, Study 502, is also currently ongoing, evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. The top-line data readout from Study 502 is expected later in the second quarter of 2024.
Intra-Cellular intends to file a supplemental new drug application seeking approval for lumateperone as adjunctive therapy to antidepressants for the treatment of MDD with the FDA in the second half of 2024.
We remind the investors that a third phase III study, Study 505, is also evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. This additional registrational study is intended to support a regulatory filing seeking label expansion of the drug for this indication if needed.
Intra-Cellular Therapies Inc. Price and EPS Surprise
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share has remained constant at $4.56. During the same time frame, the estimate for Ligand’s 2025 earnings per share has remained constant at $5.27. Year to date, shares of LGND have gained 2.5%.
Ligand beat estimates in each of the trailing four quarters, delivering an average surprise of 56.02%.
In the past 30 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have risen from $4.43 to $4.44. Meanwhile, during the same period, the estimate for ANI Pharmaceuticals’ 2025 earnings per share has remained constant at $5.04. Year to date, shares of ANIP have climbed 21%.
ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average surprise of 109.06%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.35 to $2.93. During the same period, the estimate for Annovis’ 2025 loss per share has widened from $2.82 to $2.83. Year to date, shares of ANVS have plunged 71.4%.
ANVS beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Intra-Cellular (ITCI) Q1 Earnings and Sales Beat Estimates
Intra-Cellular Therapies, Inc. (ITCI - Free Report) reported first-quarter 2024 loss of 16 cents per share, narrower than the Zacks Consensus Estimate of a loss of 31 cents, primarily due to higher product sales. The company had incurred a loss of 46 cents per share in the year-ago quarter.
Total revenues, comprising product sales and grant revenues, came in at $144.9 million compared with $95.3 million reported in the year-ago period. The top line beat the Zacks Consensus Estimate of $141.9 million.
Quarter in Detail
Caplyta, the only approved drug in Intra-Cellular’s portfolio, was approved by the FDA in December 2019, for treating schizophrenia in adults. The drug also received the FDA’s approval for treating bipolar depression in December 2021. Post this approval, Caplyta sales have increased tremendously.
Net product revenues, comprising Caplyta sales, were up 53% year over year to $144.8 million on the back of strong prescription uptake.
Per Intra-Cellular, Caplyta prescriptions jumped 39% year over year, despite typical first-quarter seasonal dynamics as well as industry disruption.
Research and development (R&D) expenses climbed 13% to $42.8 million from the year-ago quarter’s figure. This uptick was due to higher lumateperone program costs.
Selling, general and administrative (SG&A) expenses increased 14% year over year to $113.1 million, driven by marketing and advertising costs.
Year to date, shares of the company have lost 0.6% compared with the industry’s 6.2% decline.
Image Source: Zacks Investment Research
As of Mar 31, 2024, ITCI had cash, cash equivalents, restricted cash and investment securities of $477.4 million compared with $499.7 million as of Dec 31, 2023.
2024 Financial Outlook Reaffirmed
Intra-Cellular reiterated its previously announced financial guidance for 2024. It expects Caplyta net product sales in the range of $645-$675 million.
R&D expenses are expected in the band of $215-$240 million.
SG&A expenses are anticipated between $450 million and $480 million.
Key Pipeline Updates
Last month, Intra-Cellular announced positive top-line results from its late-stage study evaluating lumateperone 42 mg for the treatment of major depressive disorder (MDD). Statistically significant efficacy upon treatment of MDD patients with lumateperone 42 mg was observed as early as after one week of dosing, which was maintained throughout the study in the primary and key secondary endpoints.
A second phase III study, Study 502, is also currently ongoing, evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. The top-line data readout from Study 502 is expected later in the second quarter of 2024.
Intra-Cellular intends to file a supplemental new drug application seeking approval for lumateperone as adjunctive therapy to antidepressants for the treatment of MDD with the FDA in the second half of 2024.
We remind the investors that a third phase III study, Study 505, is also evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. This additional registrational study is intended to support a regulatory filing seeking label expansion of the drug for this indication if needed.
Intra-Cellular Therapies Inc. Price and EPS Surprise
Intra-Cellular Therapies Inc. price-eps-surprise | Intra-Cellular Therapies Inc. Quote
Zacks Rank & Stocks to Consider
Intra-Cellular currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are Ligand Pharmaceuticals (LGND - Free Report) , ANI Pharmaceuticals (ANIP - Free Report) and Annovis Bio (ANVS - Free Report) . While LGND sports a Zacks Rank #1 (Strong Buy), ANIP & ANVS carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share has remained constant at $4.56. During the same time frame, the estimate for Ligand’s 2025 earnings per share has remained constant at $5.27. Year to date, shares of LGND have gained 2.5%.
Ligand beat estimates in each of the trailing four quarters, delivering an average surprise of 56.02%.
In the past 30 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have risen from $4.43 to $4.44. Meanwhile, during the same period, the estimate for ANI Pharmaceuticals’ 2025 earnings per share has remained constant at $5.04. Year to date, shares of ANIP have climbed 21%.
ANI Pharmaceuticals beat estimates in each of the last four quarters, delivering an average surprise of 109.06%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.35 to $2.93. During the same period, the estimate for Annovis’ 2025 loss per share has widened from $2.82 to $2.83. Year to date, shares of ANVS have plunged 71.4%.
ANVS beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.