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Intra-Cellular Therapeutics (ITCI - Free Report) incurred a loss of 45 cents per share in fourth-quarter 2022, narrower than the Zacks Consensus Estimate of a loss of 62 cents. The reported loss per share is also narrower than the year-ago loss per share of $1.05.
Intra-Cellular’s total revenues, comprising product sales, came in at $88 million in the fourth quarter compared with $26 million reported in the year-ago period. Revenues beat the Zacks Consensus Estimate of $83 million.
Shares of Intra-Cellular have declined 11.9% in the past year compared with the industry’s fall of 9.9%.
Image Source: Zacks Investment Research
Quarter in Detail
Caplyta is the only approved drug in Intra-Cellular’s portfolio. The FDA approved Caplyta for treating schizophrenia in adults in December 2019. Caplyta received FDA approval for bipolar depression in December 2021. Post the approval of the bipolar indication, Caplyta sales have increased tremendously.
In the reported quarter, net product revenues comprising Caplyta sales were up 243% year over year at $87.4 million from $25.5 million in the year-ago quarter. Net product revenues in the reported quarter were up 22% sequentially.
Per management, Caplyta’s total and new prescriptions increased by 193% and 220%, respectively, year over year in the reported quarter from the year-ago quarter’s levels.
In the third quarter, research and development (R&D) expenses were $33.9 million, up 15% from the year-ago quarter’s figure, owing to the higher clinical and non-clinical costs of the lumateperone study and an increase in non-lumateperone program costs.
Selling, general and administrative (SG&A) expenses also surged 18.7% year over year to $94.6 million, owing to a rise in marketing and advertising expenses and commercialization costs.
As of Dec 31, 2022, ITCI had cash, cash equivalents, restricted cash and investment securities of $593.7 million compared with $630.5 million as of Sep 30, 2022.
2022 Results
Total revenues were up 199% over the previous year’s figure to $250.3 million, which just beat the Zacks Consensus Estimate of $245.68 million for the same period. Net product sales of Caplyta as of December end, were $249.1 million, up 205% year over year.
For the full year 2022, the company’s loss per share was recorded at $2.72 per share, narrower than the Zacks Consensus Estimate of a loss of $2.86. Loss per share of the company recorded for the year 2021 stood at $3.50.
2023 Financial Outlook
Intra-Cellular expects Caplyta net product sales to be in the range of $430 to $455 million, rolling into 2023.
R&D expenses, for the full year 2023, are expected to be $195 to $220 million.
For the full year 2023, SG&A expenses are expected to be $420 to $450 million. These expenses are set to increase in the following year owing to commercialization expenses, such as sales and marketing activities related to Caplyta.
Pipeline Updates
Presently, lumateperone is being developed in a phase III study as a treatment for major depressive disorder (MDD). Enrollment is in progress for the company’s global phase III studies 501 and 502, evaluating 42 mg of lumateperone as a treatment for MDD. 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 2024.
The company is also evaluating lumateperone in treating major depressive episodes associated with bipolar I or bipolar II disorder. A phase III study 403 evaluating 42mg of lumateperone in the aforementioned indication is expected to be completed soon. Top-line data from the study is expected in the first quarter of 2023, following which the company intends to consult with the FDA for a potential regulatory filing for the indication.
Intra-Cellular Therapies Inc. Price, Consensus and EPS Surprise
In the past 90 days, the estimate for Allogene’s 2022 loss per share has narrowed from $2.85 to $2.83. During the same period, the loss estimate per share for 2023 has narrowed from $2.82 to $2.69. In the past year, the shares of Allogene have fallen 26.3%.
ALLO’s earnings witnessed an average earnings surprise of 8.33%, beating all four estimates in the trailing four reported quarters.
In the past 90 days, the consensus estimate for ADMA Biologics’ 2022 loss per share has been flat at a loss of 33 cents. But, during the same period, the loss estimate per share for 2023 has narrowed from 20 cents to 19 cents. In the past year, the shares of ADMA Biologics have increased by 117.8%.
ADMA’s earnings beat estimates in three of the trailing four quarters, delivering an average earnings surprise of 1.81%.
In the past 90 days, the estimate for Amarin’s 2022 loss per share has been flat at a loss of 13 cents. During the same period, the loss estimate per share for 2023 has narrowed from 8 cents to 6 cents. In the past year, the shares of Amarin have fallen 35%.
AMRN’s earnings witnessed an average loss surprise of 14.29%, beating two out of four estimates in the trailing four reported quarters and missing the mark on the other two occasions.
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Intra-Cellular (ITCI) Q4 Earnings & Sales Top, Caplyta Shines
Intra-Cellular Therapeutics (ITCI - Free Report) incurred a loss of 45 cents per share in fourth-quarter 2022, narrower than the Zacks Consensus Estimate of a loss of 62 cents. The reported loss per share is also narrower than the year-ago loss per share of $1.05.
Intra-Cellular’s total revenues, comprising product sales, came in at $88 million in the fourth quarter compared with $26 million reported in the year-ago period. Revenues beat the Zacks Consensus Estimate of $83 million.
Shares of Intra-Cellular have declined 11.9% in the past year compared with the industry’s fall of 9.9%.
Image Source: Zacks Investment Research
Quarter in Detail
Caplyta is the only approved drug in Intra-Cellular’s portfolio. The FDA approved Caplyta for treating schizophrenia in adults in December 2019. Caplyta received FDA approval for bipolar depression in December 2021. Post the approval of the bipolar indication, Caplyta sales have increased tremendously.
In the reported quarter, net product revenues comprising Caplyta sales were up 243% year over year at $87.4 million from $25.5 million in the year-ago quarter. Net product revenues in the reported quarter were up 22% sequentially.
Per management, Caplyta’s total and new prescriptions increased by 193% and 220%, respectively, year over year in the reported quarter from the year-ago quarter’s levels.
In the third quarter, research and development (R&D) expenses were $33.9 million, up 15% from the year-ago quarter’s figure, owing to the higher clinical and non-clinical costs of the lumateperone study and an increase in non-lumateperone program costs.
Selling, general and administrative (SG&A) expenses also surged 18.7% year over year to $94.6 million, owing to a rise in marketing and advertising expenses and commercialization costs.
As of Dec 31, 2022, ITCI had cash, cash equivalents, restricted cash and investment securities of $593.7 million compared with $630.5 million as of Sep 30, 2022.
2022 Results
Total revenues were up 199% over the previous year’s figure to $250.3 million, which just beat the Zacks Consensus Estimate of $245.68 million for the same period. Net product sales of Caplyta as of December end, were $249.1 million, up 205% year over year.
For the full year 2022, the company’s loss per share was recorded at $2.72 per share, narrower than the Zacks Consensus Estimate of a loss of $2.86. Loss per share of the company recorded for the year 2021 stood at $3.50.
2023 Financial Outlook
Intra-Cellular expects Caplyta net product sales to be in the range of $430 to $455 million, rolling into 2023.
R&D expenses, for the full year 2023, are expected to be $195 to $220 million.
For the full year 2023, SG&A expenses are expected to be $420 to $450 million. These expenses are set to increase in the following year owing to commercialization expenses, such as sales and marketing activities related to Caplyta.
Pipeline Updates
Presently, lumateperone is being developed in a phase III study as a treatment for major depressive disorder (MDD). Enrollment is in progress for the company’s global phase III studies 501 and 502, evaluating 42 mg of lumateperone as a treatment for MDD. 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 2024.
The company is also evaluating lumateperone in treating major depressive episodes associated with bipolar I or bipolar II disorder. A phase III study 403 evaluating 42mg of lumateperone in the aforementioned indication is expected to be completed soon. Top-line data from the study is expected in the first quarter of 2023, following which the company intends to consult with the FDA for a potential regulatory filing for the indication.
Intra-Cellular Therapies Inc. Price, Consensus and EPS Surprise
Intra-Cellular Therapies Inc. price-consensus-eps-surprise-chart | Intra-Cellular Therapies Inc. Quote
Zacks Rank and Stocks to Consider
Intra-Cellular currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Allogene Therapeutics, Inc. (ALLO - Free Report) , ADMA Biologics, Inc. (ADMA - Free Report) and Amarin Corporation plc (AMRN - Free Report) , all carrying a Zacks Ranks #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the estimate for Allogene’s 2022 loss per share has narrowed from $2.85 to $2.83. During the same period, the loss estimate per share for 2023 has narrowed from $2.82 to $2.69. In the past year, the shares of Allogene have fallen 26.3%.
ALLO’s earnings witnessed an average earnings surprise of 8.33%, beating all four estimates in the trailing four reported quarters.
In the past 90 days, the consensus estimate for ADMA Biologics’ 2022 loss per share has been flat at a loss of 33 cents. But, during the same period, the loss estimate per share for 2023 has narrowed from 20 cents to 19 cents. In the past year, the shares of ADMA Biologics have increased by 117.8%.
ADMA’s earnings beat estimates in three of the trailing four quarters, delivering an average earnings surprise of 1.81%.
In the past 90 days, the estimate for Amarin’s 2022 loss per share has been flat at a loss of 13 cents. During the same period, the loss estimate per share for 2023 has narrowed from 8 cents to 6 cents. In the past year, the shares of Amarin have fallen 35%.
AMRN’s earnings witnessed an average loss surprise of 14.29%, beating two out of four estimates in the trailing four reported quarters and missing the mark on the other two occasions.