Intra-Cellular (ITCI) Beat on Q3 Earnings and Sales Estimates
Intra-Cellular Therapeutics ITCI incurred a loss of 57 cents per share in third-quarter 2022, narrower than the year-ago quarter’s loss of 95 cents and beating the Zacks Consensus Estimate of a loss of 86 cents.
Intra-Cellular’s total revenues, comprising product sales, came in at $72 million in the third quarter compared with $22.2 million reported in the year-ago period. Revenues beat the Zacks Consensus Estimate of $65 million.
Shares of Intra-Cellular have declined 0.9% in the year so far compared with the industry’s fall of 20.4%.
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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 and is currently the first and only treatment for the indication. Post the approval of the bipolar indication, Caplyta sales have increased tremendously.
In the reported quarter, net product revenues comprising Caplyta sales were up 233% year over year at $72 million compared with $21.6 million in the year-ago quarter.
Compared with the year-ago quarter’s levels, Caplyta’s total prescriptions increased by 220% year over year in the reported quarter.
In the third quarter, research and development expenses were $33.3 million, up 23.1% 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 expenses also surged 25.4% year over year to $88.4 million, owing to a rise in marketing and advertising expenses and labor-related costs.
As of Sep 30, 2022, ITCI had cash, cash equivalents, restricted cash and investment securities of $630.5 compared with $600.6 million as of Jun 30, 2022.
Pipeline Updates
In the third quarter, Intra-Cellular launched two new dosage strengths of Caplyta (lumateperone), 10.5 mg and 21 mg.
Presently, lumateperone is being developed in a phase III study as a treatment for 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 (sNDA) 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 by the end of 2022. 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.
Lumateperone is also being evaluated for relapse prevention in schizophrenic patients in a phase III study.
IntraCellular Therapies Inc. Price, Consensus and EPS Surprise
IntraCellular Therapies Inc. price-consensus-eps-surprise-chart | IntraCellular Therapies Inc. Quote
Zacks Rank & Stocks to Consider
Intra-Cellular currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector are Intellia Therapeutics NTLA, carrying a Zacks Rank #1 (Strong Buy) and Kodiak Sciences KOD and Puma Biotechnology PBYI, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Intellia Therapeutics’ loss estimates for 2022 have improved from $5.82 to $5.78 in the past 30 days. Shares of Intellia have declined 56.3% year to date. Earnings of NTLA missed earnings estimates in all the last four quarters. NTLA delivered a negative earnings surprise of 28%, on average.
Kodiak Sciences’ loss estimates for 2022 have remained steady at $7.12 in the past 30 days. Shares of Kodiak have declined 91.8% year to date. Earnings of KOD beat earnings estimates only once in the last four quarters. KOD delivered a negative earnings surprise of 20.20%, on average
Puma Biotechnology’s loss estimates for 2022 have remained steady at 6 cents the past 30 days. Shares of PBYI have declined 29.7% year to date. Earnings of Puma beat earnings estimates in three of the trailing four quarters and missed the same in the remaining occasion. PBYI delivered an earnings surprise of 201.37%, on average.
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