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Intra-Cellular (ITCI) Q2 Loss Narrower Than Expected, Sales Beat
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Intra-Cellular Therapies, Inc. (ITCI - Free Report) reported second-quarter 2024 loss of 16 cents per share, narrower than the Zacks Consensus Estimate of a loss of 18 cents, primarily due to higher product sales. The company had incurred a loss of 45 cents per share in the year-ago quarter.
Total revenues, comprising product sales and grant revenues, came in at $161.4 million, up 46% year over year. The top line beat the Zacks Consensus Estimate of $158 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 46% year over year to $161.3 million on the back of strong prescription uptake. Per Intra-Cellular, Caplyta prescriptions jumped 36% year over year and 10% sequentially, reflecting its continued strong uptake in market share gains in bipolar depression.
To maximize the sales potential of Caplyta for its approved indications, the company is planning to increase its sales force during the third quarter of 2024 to expand its accessibility to primary care physicians. Hence, Intra-Cellular is set to hire 150 additional sales representatives.
Research and development (R&D) expenses climbed 13% to $56.2 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 20% year over year to $121.6 million, driven by marketing and advertising costs.
Year to date, shares of the company have gained 2.8% against the industry’s 5.9% decline.
Image Source: Zacks Investment Research
As of Jun 30, 2024, ITCI had cash, cash equivalents, restricted cash and investment securities of $1.025 billion compared with $477.4 million as of Mar 31, 2024.
2024 Financial Outlook Updated
Intra-Cellular updated its previously announced financial guidance for 2024. It now expects higher full-year Caplyta net product sales in the range of $650-$680 million compared with the previously guided range of $645-$675 million.
The company’s R&D expenses are projected in the range of $210-$230 million, down from the previous guidance of $215-$240 million.
Intra-Cellar expects SG&A expenses in the range of $480-$510 million, up from the previously guided range of $450-$480 million due to an anticipated increase in sales, marketing and other expenses associated with the sales force expansion in the primary care segment in the second half of 2024.
Key Pipeline Updates
In June, Intra-Cellar announced positive top-line results from Study 502, the second late-stage study that evaluated lumateperone 42 mg for the treatment of major depressive disorder (MDD). The phase III Study 502 of lumateperone 42 mg, given once daily as an adjunctive therapy to antidepressants for MDD, met the primary endpoint as well as the key secondary endpoint with statistical significance.
Please note that in April 2024, Intra-Cellular reported the success of its first late-stage Study 501 evaluating lumateperone 42 mg, which also achieved statistically significant and clinically meaningful results in the same primary and the key secondary endpoints.
Per the company, the success of both the phase III studies, Study 501 and Study 502, forms the basis for a regulatory filing seeking the label expansion of lumateperone as an adjunctive treatment of MDD. Intra-Cellular anticipates the submission of a supplemental new drug application for lumateperone in the United States to treat the MDD indication 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.
In the past 60 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $1.95 to $1.91. Year to date, shares of ANVS have plunged 57.1%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 60 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2024 loss per share has narrowed from 44 cents to 43 cents. During the same time frame, the estimate for Anixa Biosciences’ 2025 loss per share has remained constant at 45 cents. Year to date, shares of ANIX have lost 22.2%.
ANIX beat estimates in three of the trailing four quarters and missed the mark once, delivering an average earnings surprise of 2.27%.
In the past 60 days, estimates for Akero Therapeutics’ 2024 loss per share have narrowed from $3.87 to $3.82. During the same period, loss per share estimates for 2025 have remained constant at $4.29. Year to date, shares of AKRO have gained 1.4%.
Akero’s earnings beat estimates in one of the trailing four quarters, missed twice and matched once, delivering an average negative surprise of 5.10%.
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Intra-Cellular (ITCI) Q2 Loss Narrower Than Expected, Sales Beat
Intra-Cellular Therapies, Inc. (ITCI - Free Report) reported second-quarter 2024 loss of 16 cents per share, narrower than the Zacks Consensus Estimate of a loss of 18 cents, primarily due to higher product sales. The company had incurred a loss of 45 cents per share in the year-ago quarter.
Total revenues, comprising product sales and grant revenues, came in at $161.4 million, up 46% year over year. The top line beat the Zacks Consensus Estimate of $158 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 46% year over year to $161.3 million on the back of strong prescription uptake. Per Intra-Cellular, Caplyta prescriptions jumped 36% year over year and 10% sequentially, reflecting its continued strong uptake in market share gains in bipolar depression.
To maximize the sales potential of Caplyta for its approved indications, the company is planning to increase its sales force during the third quarter of 2024 to expand its accessibility to primary care physicians. Hence, Intra-Cellular is set to hire 150 additional sales representatives.
Research and development (R&D) expenses climbed 13% to $56.2 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 20% year over year to $121.6 million, driven by marketing and advertising costs.
Year to date, shares of the company have gained 2.8% against the industry’s 5.9% decline.
Image Source: Zacks Investment Research
As of Jun 30, 2024, ITCI had cash, cash equivalents, restricted cash and investment securities of $1.025 billion compared with $477.4 million as of Mar 31, 2024.
2024 Financial Outlook Updated
Intra-Cellular updated its previously announced financial guidance for 2024. It now expects higher full-year Caplyta net product sales in the range of $650-$680 million compared with the previously guided range of $645-$675 million.
The company’s R&D expenses are projected in the range of $210-$230 million, down from the previous guidance of $215-$240 million.
Intra-Cellar expects SG&A expenses in the range of $480-$510 million, up from the previously guided range of $450-$480 million due to an anticipated increase in sales, marketing and other expenses associated with the sales force expansion in the primary care segment in the second half of 2024.
Key Pipeline Updates
In June, Intra-Cellar announced positive top-line results from Study 502, the second late-stage study that evaluated lumateperone 42 mg for the treatment of major depressive disorder (MDD). The phase III Study 502 of lumateperone 42 mg, given once daily as an adjunctive therapy to antidepressants for MDD, met the primary endpoint as well as the key secondary endpoint with statistical significance.
Please note that in April 2024, Intra-Cellular reported the success of its first late-stage Study 501 evaluating lumateperone 42 mg, which also achieved statistically significant and clinically meaningful results in the same primary and the key secondary endpoints.
Per the company, the success of both the phase III studies, Study 501 and Study 502, forms the basis for a regulatory filing seeking the label expansion of lumateperone as an adjunctive treatment of MDD. Intra-Cellular anticipates the submission of a supplemental new drug application for lumateperone in the United States to treat the MDD indication 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.
Intra-Cellular Therapies Inc. Price and Consensus
Intra-Cellular Therapies Inc. price-consensus-chart | Intra-Cellular Therapies Inc. Quote
Zacks Rank & Stocks to Consider
Intra-Cellular currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Annovis Bio (ANVS - Free Report) , Anixa Biosciences (ANIX - Free Report) and Akero Therapeutics (AKRO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $1.95 to $1.91. Year to date, shares of ANVS have plunged 57.1%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 60 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2024 loss per share has narrowed from 44 cents to 43 cents. During the same time frame, the estimate for Anixa Biosciences’ 2025 loss per share has remained constant at 45 cents. Year to date, shares of ANIX have lost 22.2%.
ANIX beat estimates in three of the trailing four quarters and missed the mark once, delivering an average earnings surprise of 2.27%.
In the past 60 days, estimates for Akero Therapeutics’ 2024 loss per share have narrowed from $3.87 to $3.82. During the same period, loss per share estimates for 2025 have remained constant at $4.29. Year to date, shares of AKRO have gained 1.4%.
Akero’s earnings beat estimates in one of the trailing four quarters, missed twice and matched once, delivering an average negative surprise of 5.10%.