Bristol Myers Squibb Strengthens and Diversifies Presence in Neuroscience with Acquisition of Karuna Therapeutics
Transaction strengthens BMS’ neuroscience portfolio with addition of KarXT, a first-in-class M1 and M4 muscarinic receptor agonist, and an early-stage and pre-clinical pipeline
Delivering Meaningful Benefits to Patients with KarXT
KarXT has meaningful and expanding revenue potential for schizophrenia with upside in additional indications:
SCHIZOPHRENIA
KarXT is expected to launch in late 2024 in the U.S. as a treatment for schizophrenia in adults, with a PDUFA date of 9/26/24. There are ~1.6M1 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.
ALZHEIMER’S DISEASE PSYCHOSIS
Registrational clinical trials are currently underway evaluating KarXT for treatment of Alzheimer’s disease psychosis, with data expected in 2026. There are more than 6M2 people living with
Alzheimer’s disease in the U.S. There are currently no approved treatments for Alzheimer’s disease psychosis.
ADJUNCTIVE SCHIZOPHRENIA
A registrational clinical trial is currently underway evaluating KarXT as an adjunctive treatment with current standard of care agents for treatment of schizophrenia, with data expected in 2025.
ADDITIONAL INDICATIONS
BMS believes KarXT also has potential in additional indications, including Bipolar I disorder, which impacts
~1.4M1 people in the U.S., and Alzheimer’s disease agitation.
1
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Source: DRG – Clarivate, as of July 2023.
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2
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Source: Alzheimer’s Disease Association, 2023.
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Additional Information and Where to Find it
In connection with the proposed acquisition of Karuna Therapeutics by Bristol Myers Squibb, Karuna Therapeutics intends to file a preliminary and definitive proxy statement. The definitive proxy
statement and proxy card will be delivered to the stockholders of Karuna Therapeutics in advance of the special meeting relating to the proposed acquisition. This communication is not a substitute for the proxy statement or any
other document that may be filed by Karuna Therapeutics with the SEC. KARUNA THERAPEUTICS’ STOCKHOLDERS AND INVESTORS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS
FILED BY EACH OF BRISTOL MYERS SQUIBB AND KARUNA THERAPEUTICS WITH THE SEC IN CONNECTION WITH THE PROPOSED ACQUISITION OR
INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
ACQUISITION AND THE PARTIES TO THE
PROPOSED ACQUISITION. Investors and security holders will be able to obtain a free copy of the proxy statement and such other documents containing important information about Bristol Myers Squibb and
Karuna Therapeutics, once such documents are filed with the SEC, through the website maintained by the SEC at www.sec.gov. Bristol Myers Squibb and Karuna Therapeutics make available free of charge at Bristol Myers Squibb’s website
at
www.bms.com/investors and Karuna Therapeutics’ website at
https://karunatx.com/, respectively, copies of materials they file with, or furnish to, the SEC.
Participants in the Solicitation
This communication does not constitute a solicitation of a proxy, an offer to purchase or a solicitation of an offer to sell any securities. Bristol Myers Squibb, Karuna Therapeutics and their
respective directors, executive officers and certain employees may be deemed to be participants in the solicitation of proxies from the stockholders of Karuna Therapeutics in connection with the proposed acquisition. Information
regarding Bristol Myers Squibb’s directors and executive officers is contained in Bristol Myer Squibb’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2022, which was filed with the SEC on
February 14, 2023, and
its definitive proxy statement for the 2023 annual meeting of stockholders, which was filed with the SEC on
March 23, 2023. Information regarding Karuna Therapeutics’ directors and executive officers is contained in Karuna
Therapeutics’ definitive proxy statement for the 2023 annual meeting of stockholders, which was filed with the SEC on
April 27, 2023. To the extent holdings of Bristol Myers Squibb’s or Karuna Therapeutics’ securities by their
respective directors or executive officers have changed since the amounts set forth in such 2023 proxy statements, such changes have been or will be reflected on Initial Statements of Beneficial Ownership on Form 3 or Statements of
Beneficial Ownership on Form 4 filed with the SEC. Additional information regarding the identity of potential participants, and their direct or indirect interests, by security holdings or otherwise, will be included in the
definitive proxy statement relating to the proposed acquisition when it is filed with the SEC. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov, Bristol Myers Squibb’s website at
www.bms.com and Karuna Therapeutics’ website at
https://karunatx.com/.
Cautionary Statement Regarding Forward-Looking Statements
This communication 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 Karuna Therapeutics by Bristol Myers Squibb, the expected timetable for completing the transaction, future opportunities for the combined businesses, the expected
benefits of Bristol Myers Squibb’s acquisition of Karuna Therapeutics and the development and commercialization of Karuna Therapeutics’ product candidates, including the therapeutic and commercial potential of KarXT and Karuna
Therapeutics’ other technologies and products in development. These statements may be identified by the fact they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,”
“intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance, although not all forward-looking statements contain such
terms. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. These statements are only predictions, and such forward-looking statements are based on current expectations
and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them, that are difficult to predict, may be beyond our control and could cause actual
outcomes and results to differ materially from those expressed in, or implied by, the forward-looking statements. Actual results may differ materially because of numerous risks and uncertainties including with respect to (i) the
approval of Karuna Therapeutics’ stockholders of the proposed acquisition, which may be delayed or may not be obtained, (ii) the risk that the expected benefits or synergies of the acquisition will not be realized, (iii) the risk
that legal proceedings may be instituted related to the merger agreement, (iv) any competing offers or acquisition proposals for Karuna Therapeutics, (v) the possibility that various conditions to the consummation of the acquisition
may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the acquisition and
(vii) unanticipated difficulties or expenditures relating to the proposed acquisition, including the response of business partners and competitors to the announcement of the proposed acquisition or
difficulties in employee retention as a result of the announcement and pendency of the proposed acquisition. The actual financial impact of this transaction may differ from the expected financial impact described in this
communication. In addition, the compounds described in this communication are subject to all the risks inherent in the drug development process, and there can be no assurance that the development of these compounds will be
commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this communication should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business
and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended
December 31, 2022, and Karuna Therapeutics’ business,
particularly those identified in the risk factors discussion in Karuna Therapeutics’ Annual Report on Form 10-K for the year ended
December 31, 2022, as well as other documents that may be filed by Bristol Myers Squibb or Karuna
Therapeutics from time to time with the SEC. Neither Bristol Myers Squibb nor Karuna Therapeutics undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or
otherwise, except to the extent required by law. The forward-looking statements made in this communication relate only to events as of the date on which the statements are made and readers are cautioned not to place undue reliance
on such statements.
Use of Non-GAAP Financial Information and Financial Guidance
In discussing financial guidance, Bristol Myers Squibb refers to financial measures that are not in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The non-GAAP financial
measures are provided as supplemental information to the financial measures presented in this communication that are calculated and presented in accordance with GAAP and are presented because management has evaluated the company’s
financial results both including and excluding the adjusted items or the effects of foreign currency translation, as applicable, and believes that the non-GAAP financial measures presented portray the results of the company’s
baseline performance, supplement or enhance management, analysts and investors overall understanding of the company’s underlying financial performance and trends and facilitate comparisons among current, past and future periods.
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 Bristol Myers Squibb believes they neither relate to the ordinary course of Bristol Myers
Squibb’s business nor reflect Bristol Myers Squibb’s underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods.
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, Bristol Myers Squibb believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. The
variability of the specified items may have a significant and unpredictable impact on our future GAAP results. In addition, the non-GAAP financial guidance in this communication excludes the impact of any potential additional future
strategic acquisitions and divestitures and any specified items that have not yet been identified and quantified. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described
elsewhere in this communication.