Intra-Cellular Therapies, Inc. ITCI reported third-quarter 2024 loss of 25 cents per share, wider than the Zacks Consensus Estimate of a loss of 18 cents. The company had incurred a loss of 25 cents per share in the year-ago quarter.
Total revenues, comprising product sales and grant revenues, came in at $175.4 million, up 39% year over year. The top line beat the Zacks Consensus Estimate of $172 million.
ITCI’s Q3 Results 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. After this approval, Caplyta sales have increased tremendously.
Net product revenues, comprising Caplyta sales, were up 39% year over year to $175.2 million on the back of strong prescription uptake. Per Intra-Cellular, Caplyta prescriptions jumped 38% year over year and 9% 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 completed the expansion of its sales force in the third quarter of 2024 for increased accessibility to primary care physicians. Hence, Intra-Cellular hired 150 additional sales representatives. The company is also planning a second primary care physician sales force expansion for 2025, subject to the potential approval of Caplyta for the adjunctive treatment of major depressive disorder (MDD).
Grant revenues came in at $0.2 million in the reported quarter, down 40% year over year.
Year to date, shares of the company have gained 7.2% against the industry’s 3.3% decline.
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Research and development (R&D) expenses surged 61% to $66.8 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 26% year over year to $132.1 million, driven by marketing and advertising costs.
As of Sept. 30, 2024, ITCI had cash, cash equivalents, restricted cash and investment securities of $1 billion compared with $1.025 billion as of June 30, 2024.
ITCI Updates 2024 Financial Outlook
Intra-Cellular updated its previously announced financial guidance for 2024. It now expects higher full-year Caplyta net product sales in the range of $665-$685 million compared with the previously guided range of $650-$680 million.
The company’s R&D expenses are projected in the range of $220-$230 million, which is narrower than the previously guided range of $210-$230 million.
Intra-Cellular expects SG&A expenses in the range of $490-$510 million, which is narrower than the previously guided range of $480-$510 million. The forecast includes 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.
ITCI’s Key Pipeline Updates
Earlier this year, Intra-Cellular announced positive top-line results from Study 502, the second late-stage study that evaluated lumateperone 42 mg for treating 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.
The company met with the regulatory authorities during the third quarter of 2024 and concluded that the positive and robust results from the phase III studies, Study 501 and Study 502, will form the basis of a regulatory filing, seeking the label expansion of Caplyta. Intra-Cellular anticipates the submission of a supplemental new drug application for lumateperone in the United States to treat the MDD indication in the fourth quarter 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. Additionally, Intra-Cellular is simultaneously evaluating lumateperone for various other central nervous system indications in separate clinical studies.
Intra-Cellular Therapies Inc. Price and Consensus
Intra-Cellular Therapies Inc. Price and Consensus
Intra-Cellular Therapies Inc. price-consensus-chart | Intra-Cellular Therapies Inc. Quote
ITCI’s Zacks Rank & Stocks to Consider
Intra-Cellular currently carries a Zacks Rank #3 (Hold).
Some better-ranked pharma stocks are Bayer BAYRY, ANI Pharmaceuticals ANIP and Novartis NVS, 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.
Estimates for Bayer’s 2024 earnings per share (EPS) have increased from $1.37 to $1.38 over the past 60 days, while the same for 2025 have remained constant at $1.44. BAYRY’s shares have lost 24.7% year to date.
ANI Pharmaceuticals’ EPS estimates have risen from $4.68 to $4.73 per share for 2024 over the past 60 days, while that for 2025 has increased from $5.25 to $5.67. ANIP’s shares have risen 7% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 31.32%.
Novartis’ EPS estimates have risen from $7.48 to $7.55 per share for 2024 over the past 60 days, while that for 2025 has increased from $8.29 to $8.32. NVS’ shares have risen 9.5% year to date.
Novartis’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 2.22%.
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