Intra-Cellular Therapies ITCI reported a loss of 30 cents per share for the fourth quarter of 2023, narrower than the Zacks Consensus Estimate of a loss of 44 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 $132 million compared with $88 million in the year-ago period. However, the top line missed the Zacks Consensus Estimate of $136 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 50% year over year to $131.5 million on the back of strong prescription uptake.
Per Intra-Cellular, Caplyta prescriptions increased 55% year over year in the fourth quarter of 2023 and 10% sequentially.
Research and development (R&D) expenses jumped 50% to $51 million from the year-ago quarter’s figure. This uptick was mainly due to higher lumateperone program costs.
Selling, general and administrative (SG&A) expenses increased 11% year over year to $105 million, driven by marketing and advertising costs.
Shares of the company have rallied 51% in the past year against the industry’s decline of 10.3%.
Zacks Investment Research
Image Source: Zacks Investment Research
As of Dec 31, 2023, ITCI had cash, cash equivalents, restricted cash and investment securities of $499.7 million compared with $494.8 million as of Sep 30, 2023.
Full-Year Results
Total revenues were up 86% year over year to $464.37 million, which missed the Zacks Consensus Estimate of $468.57 million.
Net product sales of Caplyta, as of December end, were $462.2 million, up 86% year over year. The increase was driven bystrong underlying prescription demand, which surged 85% year over year. The reported figure was in line with the company’s last guided range of $460-$470 million in Caplyta net sales.
For 2023, the company reported a loss of $1.46 per share, narrower than the Zacks Consensus Estimate of a loss of $1.60. The company had incurred a loss of $2.72 per share in 2022.
2024 Financial Outlook
Intra-Cellular expects Caplyta net product sales in the range of $645-$675 million.
R&D expenses, for 2024, are expected in the band of $215-$240 million. Intra-Cellular’s guidance reflects investments to support its broad pipeline, especially expenditures related to lumateperone development programs as the company continues to explore the use of lumateperone in additional patient populations.
For 2024, SG&A expenses are expected between $450 million and $480 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
Intra-Cellular is currently evaluating 42 mg of lumateperone in several late-stage studies as a treatment for major depressive disorder (MDD). The company expects top-line data from the phase III Study 501 in April 2024 and the phase III Study 502 in the second quarter of 2024.
Based on the data, the company plans to file a supplemental new drug application to the FDA seeking approval for lumateperone as adjunctive therapy to antidepressants for the treatment of MDD in the second half of 2024.
Intra-Cellular Therapies Inc. Price, Consensus and EPS Surprise
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 from the drug/biotech industry are Puma Biotechnology, Inc. PBYI, ADMA Biologics ADMA and Adicet Bio, Inc. ACET. While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA & ACET 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 Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 69 cents to 71 cents. Over the past year, shares of PBYI have risen 45.1%.
PBYI beat on earnings in three of the last four quarters and missed in the other, delivering an average surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past year, shares of ADMA have jumped 50%.
ADMA beat on earnings in three of the trailing four quarters and met in one, delivering an average surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has narrowed from $2.29 to $1.81. In the past year, shares of ACET have plunged 69.9%.
ACET’s earnings beat estimates in two of the trailing four quarters and missed in the other two, delivering an average negative surprise of 8.36%.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
