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Intra-Cellular Therapies’ (ITCI - Free Report) shares were up 2% on May 5, after the company reported better-than-expected first-quarter 2023 results on May 4.
ITCI incurred a loss of 46 cents per share in the reported quarter, narrower than the Zacks Consensus Estimate of a loss of 63 cents. The reported loss was also narrower than the year-ago quarter’s loss of 78 cents per share. This was due to higher product sales.
Total revenues, comprising product sales and grant revenues, came in at $95 million compared with $35 million in the year-ago period. The top line beat the Zacks Consensus Estimate of $92 million.
Shares of the company have gained 19.6% in the year-to-date period against the industry’s decline of 4.8%.
Image Source: Zacks Investment Research
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 approval for treating bipolar depression in December 2021. Post this approval, Caplyta sales have increased tremendously.
Net product revenues, comprising Caplyta sales, were up 173% year over year to $94.7 million from $34.8 million in the prior-year period.
Per management, the drug’s total and new prescriptions increased 159% year over year and 16% sequentially.
Research and development expenses increased 31% to $38 million from the year-ago quarter’s figure. This was due to higher clinical and non-clinical costs of the lumateperone study, and an increase in non-lumateperone program costs.
Selling, general and administrative expenses also surged 31% year over year to $98.9 million, owing to a rise in marketing and advertising expenses.
As of Mar 31, 2023, ITCI had cash, cash equivalents, restricted cash and investment securities of $540.5 million compared with $593.7 million as of Dec 31, 2022.
2023 Guidance
The company reiterated its Caplyta net product sales in the range of $430-$455 million, for 2023.
Pipeline Updates
Presently, lumateperone is being developed in a phase III study as a treatment for major depressive disorder (MDD).
The company announced positive results for lumateperone in treating MDD episodes in patients with mixed features and in those with bipolar depression with mixed features. Lumateperone 42mg met the primary and key secondary endpoints, and was generally safe and well tolerated.
It is also being developed as an adjunctive therapy to antidepressants for the treatment of MDD in phase III studies.
Intra-Cellular Therapies Inc. Price and EPS Surprise
Intra-Cellular currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks for investors interested in the same sector are Ocuphire Pharma (OCUP - Free Report) , Allogene Therapeutics (ALLO - Free Report) and Arcus Biosciences (RCUS - Free Report) . While Ocuphire Pharma sports a Zacks Rank #1 (Strong Buy), Allogene Therapeutics and Arcus Biosciences, both carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Ocuphire Pharma have narrowed from 29 cents to 24 cents for 2023 and from 86 cents to 81 cents for 2024, in the past 60 days.
The company’s shares have surged 75.1% in the year-to-date period. Ocuphire’s earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 23.85%.
Loss per share estimates for Allogene have narrowed from $2.56 to $2.32 for 2023 and from $2.53 to $2.22 for 2024, in the past 60 days. Shares of ALLO have gained 4.9% in the year-to-date period.
Allogene’s earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 5.08%.
Loss per share estimates for Arcus Biosciences have narrowed from $4.52 to $4.42 for 2023 and from $3.51 to $3.33 for 2024, in the past 60 days. Shares of RCUS have plunged 5.4% in the year-to-date period.
Arcus Biosciences’ earnings outpaced estimates in two of the last four quarters, met the mark in one and missed in another, the average negative surprise being 48.83%.
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Intra-Cellular (ITCI) Q1 Earnings Top, Caplyta Volume Rises
Intra-Cellular Therapies’ (ITCI - Free Report) shares were up 2% on May 5, after the company reported better-than-expected first-quarter 2023 results on May 4.
ITCI incurred a loss of 46 cents per share in the reported quarter, narrower than the Zacks Consensus Estimate of a loss of 63 cents. The reported loss was also narrower than the year-ago quarter’s loss of 78 cents per share. This was due to higher product sales.
Total revenues, comprising product sales and grant revenues, came in at $95 million compared with $35 million in the year-ago period. The top line beat the Zacks Consensus Estimate of $92 million.
Shares of the company have gained 19.6% in the year-to-date period against the industry’s decline of 4.8%.
Image Source: Zacks Investment Research
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 approval for treating bipolar depression in December 2021. Post this approval, Caplyta sales have increased tremendously.
Net product revenues, comprising Caplyta sales, were up 173% year over year to $94.7 million from $34.8 million in the prior-year period.
Per management, the drug’s total and new prescriptions increased 159% year over year and 16% sequentially.
Research and development expenses increased 31% to $38 million from the year-ago quarter’s figure. This was due to higher clinical and non-clinical costs of the lumateperone study, and an increase in non-lumateperone program costs.
Selling, general and administrative expenses also surged 31% year over year to $98.9 million, owing to a rise in marketing and advertising expenses.
As of Mar 31, 2023, ITCI had cash, cash equivalents, restricted cash and investment securities of $540.5 million compared with $593.7 million as of Dec 31, 2022.
2023 Guidance
The company reiterated its Caplyta net product sales in the range of $430-$455 million, for 2023.
Pipeline Updates
Presently, lumateperone is being developed in a phase III study as a treatment for major depressive disorder (MDD).
The company announced positive results for lumateperone in treating MDD episodes in patients with mixed features and in those with bipolar depression with mixed features. Lumateperone 42mg met the primary and key secondary endpoints, and was generally safe and well tolerated.
It is also being developed as an adjunctive therapy to antidepressants for the treatment of MDD in phase III studies.
Intra-Cellular Therapies Inc. Price and EPS Surprise
Intra-Cellular Therapies Inc. price-eps-surprise | Intra-Cellular Therapies Inc. Quote
Zacks Rank and Stocks to Consider
Intra-Cellular currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks for investors interested in the same sector are Ocuphire Pharma (OCUP - Free Report) , Allogene Therapeutics (ALLO - Free Report) and Arcus Biosciences (RCUS - Free Report) . While Ocuphire Pharma sports a Zacks Rank #1 (Strong Buy), Allogene Therapeutics and Arcus Biosciences, both carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Ocuphire Pharma have narrowed from 29 cents to 24 cents for 2023 and from 86 cents to 81 cents for 2024, in the past 60 days.
The company’s shares have surged 75.1% in the year-to-date period. Ocuphire’s earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 23.85%.
Loss per share estimates for Allogene have narrowed from $2.56 to $2.32 for 2023 and from $2.53 to $2.22 for 2024, in the past 60 days. Shares of ALLO have gained 4.9% in the year-to-date period.
Allogene’s earnings beat estimates in three of the last four quarters and missed the mark in one, the average surprise being 5.08%.
Loss per share estimates for Arcus Biosciences have narrowed from $4.52 to $4.42 for 2023 and from $3.51 to $3.33 for 2024, in the past 60 days. Shares of RCUS have plunged 5.4% in the year-to-date period.
Arcus Biosciences’ earnings outpaced estimates in two of the last four quarters, met the mark in one and missed in another, the average negative surprise being 48.83%.