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Intra-Cellular's (ITCI) Caplyta Boosts Sales, Dependence a Woe
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Intra-Cellular (ITCI - Free Report) is a commercial-stage biotech company focused on discovering, developing and commercializing small molecule drugs for treating neuropsychiatric and neurological disorders. The company currently has one marketed drug in its portfolio, Caplyta (lumateperone 42 mg).
The FDA initially approved Caplyta for the treatment of schizophrenia in adults in December 2019, while the commercial launch began in March 2020. In December 2021, Caplyta’s indication was further expanded to treat bipolar depression in adults. Caplyta is currently the only approved treatment, both as monotherapy and as adjunctive therapy with lithium or valproate, for depressive episodes associated with bipolar I or II disorder in adults.
Moreover, in April 2022, the FDA approved two new dosage strengths of Caplyta, 10.5 mg and 21 mg for patients concomitantly taking strong or moderate CYP3A4 inhibitors and 21 mg for patients with moderate or severe hepatic impairment. These new dosage strengths have expanded the eligible patient population for Caplyta.
After the launch of its bipolar depression indication, Caplyta sales have increased, with the drug witnessing robust initial prescription growth. The company has also witnessed an increase in Caplyta prescriptions for the treatment of schizophrenia. Total Caplyta prescriptions grew by 85% in 2023 compared with 2022.Net product sales of Caplyta in the first quarter of 2024 were $144.8 million, representing an increase of 53% compared with the year-ago figure on the back of strong prescription uptake.
Given the strength of the drug’s clinical profile, management expects higher sales from Caplyta in future quarters.
Year to date, shares of Intra-Cellular have gained 6.9% against the industry’s 5.8% decline.
Image Source: Zacks Investment Research
Please note that the company is simultaneously evaluating lumateperone for several other indications. The most prominent of the additional indications being pursued for the drug is major depressive disorder (MDD). In the first half of 2024, the company reported achieving the primary and key secondary efficacy endpoints in two global phase III studies, 501 and 502, evaluating 42 mg of lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD.
The success of both the phase III studies, Study 501 and Study 502, forms the basis for a regulatory filing seeking the label expansion of lumateperone as an adjunctive treatment of MDD. Intra-Cellular anticipates the submission of a supplemental new drug application for lumateperone in the United States to treat the MDD indication in the second half of 2024.
If approved as an adjunctive treatment for MDD, the eligible patient population for Caplyta will be further expanded. This is expected to boost revenues for the company.
A third phase III study, Study 505, is also evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. This additional registrational study is intended to support the regulatory filing seeking label expansion of the drug for this indication if needed.
Lumateperone is also currently being evaluated for other Central Nervous System (CNS) indications in adult patients. In the fourth-quarter 2023 earnings release, Intra-Cellular announced that it has commenced its lumateperone pediatric program, which includes several ongoing studies evaluating the drug for various CNS indications.
The company is further evaluating a deuterated form of lumateperone, ITI-1248-ODT-SL, formulated as an oral disintegrating tablet for sublingual administration, making it convenient for patients who have difficulty swallowing conventional tablets. Based on encouraging phase I data, Intra-Cellular has initiated phase II programs evaluating ITI-1284-ODT-SL for the treatment of generalized anxiety disorder, psychosis in Alzheimer's disease and agitation in patients with Alzheimer’s disease. Clinical studies are set to begin soon.
Intra-Cellular’s clinical-stage pipeline also consists of other promising candidates beyond lumateperone, which are currently being developed for other CNS indications as well as cancer. The company also enjoys a comfortable cash position. As of Mar 31, 2024, ITCI had cash, cash equivalents, restricted cash and investment securities of $477.4 million and no debt compared with $499.7 million as of Dec 31, 2023.
However, the company’s dependence on a single product for growth has its risks. Any negative news related to Caplyta would adversely impact Intra-Cellular and its growth prospects. Although Caplyta sales are picking up, customer buying patterns and supply chain disruptions can have an unfavorable impact on the drug's sales in future quarters as seen during the COVID-19 pandemic.
Moreover, Intra-Cellular’s early-stage candidates are several years away from commercialization. Any failure of ongoing studies will hinder the stock’s potential significantly.Investors must note that clinical development involves a high amount of risk. Gaining approval for pipeline candidates has become more difficult, given the tough regulatory environment.
There is also considerable rivalry in the market for CNS disorder therapies. One such company operating in this market space is Axsome Therapeutics (AXSM - Free Report) . Axsome’s core CNS product candidates — AXS-05, AXS-07, AXS-12 and AXS-14 — are being developed for multiple CNS indications. In August 2022, AXSM received FDA approval for Auvelity (AXS-05) for the treatment of adults with MDD. A prospective approval for Axsome’s other candidates or label expansion of AXS-05 to treat other CNS indications will create significant competition for ITCI’s Caplyta.
Zacks Rank and Stocks to Consider
Intra-Cellular currently carries a Zacks Rank #3 (Hold).
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 55.9%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have plunged 68.2%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
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Intra-Cellular's (ITCI) Caplyta Boosts Sales, Dependence a Woe
Intra-Cellular (ITCI - Free Report) is a commercial-stage biotech company focused on discovering, developing and commercializing small molecule drugs for treating neuropsychiatric and neurological disorders. The company currently has one marketed drug in its portfolio, Caplyta (lumateperone 42 mg).
The FDA initially approved Caplyta for the treatment of schizophrenia in adults in December 2019, while the commercial launch began in March 2020. In December 2021, Caplyta’s indication was further expanded to treat bipolar depression in adults. Caplyta is currently the only approved treatment, both as monotherapy and as adjunctive therapy with lithium or valproate, for depressive episodes associated with bipolar I or II disorder in adults.
Moreover, in April 2022, the FDA approved two new dosage strengths of Caplyta, 10.5 mg and 21 mg for patients concomitantly taking strong or moderate CYP3A4 inhibitors and 21 mg for patients with moderate or severe hepatic impairment. These new dosage strengths have expanded the eligible patient population for Caplyta.
After the launch of its bipolar depression indication, Caplyta sales have increased, with the drug witnessing robust initial prescription growth. The company has also witnessed an increase in Caplyta prescriptions for the treatment of schizophrenia. Total Caplyta prescriptions grew by 85% in 2023 compared with 2022.Net product sales of Caplyta in the first quarter of 2024 were $144.8 million, representing an increase of 53% compared with the year-ago figure on the back of strong prescription uptake.
Given the strength of the drug’s clinical profile, management expects higher sales from Caplyta in future quarters.
Year to date, shares of Intra-Cellular have gained 6.9% against the industry’s 5.8% decline.
Image Source: Zacks Investment Research
Please note that the company is simultaneously evaluating lumateperone for several other indications. The most prominent of the additional indications being pursued for the drug is major depressive disorder (MDD). In the first half of 2024, the company reported achieving the primary and key secondary efficacy endpoints in two global phase III studies, 501 and 502, evaluating 42 mg of lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD.
The success of both the phase III studies, Study 501 and Study 502, forms the basis for a regulatory filing seeking the label expansion of lumateperone as an adjunctive treatment of MDD. Intra-Cellular anticipates the submission of a supplemental new drug application for lumateperone in the United States to treat the MDD indication in the second half of 2024.
If approved as an adjunctive treatment for MDD, the eligible patient population for Caplyta will be further expanded. This is expected to boost revenues for the company.
A third phase III study, Study 505, is also evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD. This additional registrational study is intended to support the regulatory filing seeking label expansion of the drug for this indication if needed.
Lumateperone is also currently being evaluated for other Central Nervous System (CNS) indications in adult patients. In the fourth-quarter 2023 earnings release, Intra-Cellular announced that it has commenced its lumateperone pediatric program, which includes several ongoing studies evaluating the drug for various CNS indications.
The company is further evaluating a deuterated form of lumateperone, ITI-1248-ODT-SL, formulated as an oral disintegrating tablet for sublingual administration, making it convenient for patients who have difficulty swallowing conventional tablets. Based on encouraging phase I data, Intra-Cellular has initiated phase II programs evaluating ITI-1284-ODT-SL for the treatment of generalized anxiety disorder, psychosis in Alzheimer's disease and agitation in patients with Alzheimer’s disease. Clinical studies are set to begin soon.
Intra-Cellular’s clinical-stage pipeline also consists of other promising candidates beyond lumateperone, which are currently being developed for other CNS indications as well as cancer. The company also enjoys a comfortable cash position. As of Mar 31, 2024, ITCI had cash, cash equivalents, restricted cash and investment securities of $477.4 million and no debt compared with $499.7 million as of Dec 31, 2023.
However, the company’s dependence on a single product for growth has its risks. Any negative news related to Caplyta would adversely impact Intra-Cellular and its growth prospects. Although Caplyta sales are picking up, customer buying patterns and supply chain disruptions can have an unfavorable impact on the drug's sales in future quarters as seen during the COVID-19 pandemic.
Moreover, Intra-Cellular’s early-stage candidates are several years away from commercialization. Any failure of ongoing studies will hinder the stock’s potential significantly.Investors must note that clinical development involves a high amount of risk. Gaining approval for pipeline candidates has become more difficult, given the tough regulatory environment.
There is also considerable rivalry in the market for CNS disorder therapies. One such company operating in this market space is Axsome Therapeutics (AXSM - Free Report) . Axsome’s core CNS product candidates — AXS-05, AXS-07, AXS-12 and AXS-14 — are being developed for multiple CNS indications. In August 2022, AXSM received FDA approval for Auvelity (AXS-05) for the treatment of adults with MDD. A prospective approval for Axsome’s other candidates or label expansion of AXS-05 to treat other CNS indications will create significant competition for ITCI’s Caplyta.
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 ALX Oncology Holdings (ALXO - Free Report) and Annovis Bio (ANVS - Free Report) , 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.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73. Year to date, shares of ALXO have plunged 55.9%.
ALX Oncology beat estimates in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has remained constant at $1.95. Year to date, shares of ANVS have plunged 68.2%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.