Bristol Myers Squibb Strengthens Neuroscience Portfolio with Acquisition of Karuna Therapeutics
Transaction Delivers KarXT, a First-in-Class M1 / M4 Muscarinic Receptor Agonist, with Differentiated Efficacy and Safety
KarXT Is a Potential First-in-Class Treatment for Schizophrenia and as an Adjunctive Therapy, and First-in-Disease Treatment for Alzheimer’s Disease Psychosis, with Promise in Additional Neuropsychiatric and Neurodegenerative Indications
KarXT Is Expected to Launch in the
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Karuna is a biopharmaceutical company driven to discover, develop and deliver transformative medicines for people living with psychiatric and neurological conditions. Karuna’s lead asset, KarXT (xanomeline-trospium), is an antipsychotic with a novel mechanism of action (MoA) and differentiated efficacy and safety. Karuna’s New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults was accepted for review by the
“There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio in the space. We expect KarXT to enhance our growth through the late 2020s and into the next decade,” said
“Schizophrenia and Alzheimer’s disease psychosis affect millions of people worldwide, with limited to no treatment options. KarXT’s novel mechanism has resulted in a transformational profile in schizophrenia, with compelling efficacy and a differentiated safety profile,” said
Delivering Meaningful Benefits to Patients with KarXT
KarXT targets both the M1 and M4 muscarinic receptors, resulting in a differentiated safety and efficacy profile. KarXT has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments, including weight gain, extrapyramidal symptoms, increased prolactin levels, akathisia and/or sedation.
Given this differentiated profile, KarXT has meaningful and expanding revenue potential in schizophrenia and with upside in additional indications and geographies:
- Schizophrenia: KarXT is expected to launch in late 2024 in the
U.S.as a treatment for schizophrenia in adults. There are approximately 1.6 million1 people treated for schizophrenia in the U.S., a significant portion of whom do not respond to currently available therapies and experience unacceptable side effects.
- Adjunctive schizophrenia: A registrational clinical trial is currently underway evaluating KarXT as adjunctive treatment with current standard of care agents for the treatment of schizophrenia, with data expected in 2025.
- Alzheimer’s disease psychosis: Registrational clinical trials are currently underway evaluating KarXT for the treatment of Alzheimer’s disease psychosis, with data expected in 2026. There are more than 6 million2 people living with Alzheimer’s disease in the
U.S.There are currently no approved treatments for Alzheimer’s disease psychosis.
- Additional indications:
Bristol Myers Squibbbelieves KarXT also has potential in additional indications, including Bipolar I disorder, which impacts approximately 1.4 million1 people in the U.S., and Alzheimer’s disease agitation.
The transaction is expected to be dilutive to Bristol Myers Squibb’s non-GAAP diluted earnings per share by approximately
Transaction Terms and Financing
Under the terms of the merger agreement,
The transaction is expected to close in the first half of 2024, subject to customary closing conditions, including approval of Karuna stockholders and receipt of required regulatory approvals.
Conference Call Information
Investors and the public can register for the live conference call here. Those unable to register can access the live conference call by dialing in the
A replay of the webcast will be available at http://investor.bms.com approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at
Additional Information and Where to Find It
In connection with the proposed acquisition of
Participants in the Solicitation
This press release does not constitute a solicitation of a proxy, an offer to purchase or a solicitation of an offer to sell any securities.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, among other things, the proposed acquisition of
Use of Non-GAAP Financial Information and Financial Guidance
In discussing financial guidance,
Non-GAAP earnings and related EPS information are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of past or future operating results. These items are excluded from non-GAAP earnings and related EPS information because
Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to or as a substitute for the related financial measures that are prepared in accordance with GAAP and are not intended to be considered in isolation and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.
A reconciliation of the forward-looking non-GAAP measures presented in this communication is not provided due to the inherent difficulty in forecasting and quantifying items that are necessary for such reconciliation. Namely, we are not able to reliably predict the impact of specified items such as unwind of inventory purchase price adjustments, accelerated depreciation and impairment of property, plant and equipment and intangible assets and stock compensation resulting from acquisition-related equity awards, or currency exchange rates beyond the next twelve months. As a result, the reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is not available without unreasonable effort. In addition,
1 Source: DRG – Clarivate, as of
2 Source: “Alzheimer’s Disease Association Facts and Figures,” 2023.
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