AI Terminal

MODULE: AI_ANALYST
Interactive Q&A, Risk Assessment, Summarization
MODULE: DATA_EXTRACT
Excel Export, XBRL Parsing, Table Digitization
MODULE: PEER_COMP
Sector Benchmarking, Sentiment Analysis
SYSTEM ACCESS LOCKED
Authenticate / Register Log In

BRISTOL MYERS SQUIBB CO

Proxy Solicitation & Information Statement Dec 22, 2023

Preview not available for this file type.

Download Source File

DFAN14A 1 ef20017355_dfan14a.htm DFAN14A Licensed to: Broadridge Financial Solutions, Inc. Document created using Broadridge PROfile 23.12.1.5186 Copyright 1995 - 2023 Broadridge

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

SCHEDULE 14A

(Rule 14a-101)

PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE

SECURITIES EXCHANGE ACT OF 1934

(AMENDMENT NO. )

Filed by the Registrant ☐

Filed by a Party other than the Registrant ☒

Check the appropriate box:

Preliminary Proxy Statement
Confidential, for Use of the Commission Only (as permitted by Rule14a-6(e)(2))
Definitive Proxy Statement
Definitive Additional Materials
Soliciting Material Pursuant to Rule 14a-12

KARUNA THERAPEUTICS, INC.

(Name of Registrant as Specified in its Charter)

BRISTOL-MYERS SQUIBB COMPANY

(Name of Person(s) Filing Proxy Statement, if other than the Registrant)

Payment of Filing Fee (Check all boxes that apply):

☒ No fee required

☐ Fee paid previously with preliminary materials

☐ Fee computed on table in exhibit required by Item 25(b) per Exchange Act Rules 14a-6(i)(1) and 0-11

Filed by Bristol-Myers Squibb Company

Pursuant to Rule 14a-12 under the

Securities Exchange Act of 1934, as amended

Subject Company: Karuna Therapeutics, Inc.

Commission File No.: 001-38958

This filing contains the following communications related to the potential acquisition of Karuna Therapeutics, Inc. (“Karuna”) by Bristol-Myers Squibb Company (“BMS”):

  1. Investor presentation published on December 22, 2023.

  2. Social media posts of BMS published on December 22, 2023.

  3. Transaction infographic dated December 22, 2023.

  4. Form of letter sent to clinical trial investigators on December 22, 2023.

  5. Form of letter sent to business partners on December 22, 2023.

  6. Form of letter sent to patient advocacy groups on December 22, 2023.

  7. Form of letter sent to regulators on December 22, 2023.

  8. The following is an investor presentation related to the potential acquisition of Karuna by BMS, published on December 22, 2023.

Bristol Myers Squibb to Acquire Karuna Therapeutics December 22, 2023

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 Myers 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. 5 Forward Looking 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. 5 Non-GAAP Financial Information

Our overarching goal is to achieve sustainable, top-quartile growth Increase company growth rate Maximize potential of the internal portfolio and pipeline Complement internal assets with disciplined business development 5

Acquisition of Karuna expands and strengthens our presence in neuroscience while augmenting our growth profile Adds Lead Asset KarXT Potential first-in-class treatment in schizophrenia and first-in-disease treatment in Alzheimer’s disease psychosis (ADP) Antipsychotic with novel M1/M4 receptor agonism; U.S. PDUFA date late Q3 2024 Compelling efficacy and differentiated safety Multi-billion-dollar peak sales opportunities across multiple indications Promising Early-Stage Opportunities Transaction is expected to close in 1H 2024, subject to customary reviews 5

Karuna accelerates the expansion and diversification of BMS’s neuroscience portfolio 6 FILED / APPROVED eIF2B (ALS and Alzheimer’s disease) FAAH/MGLL (Other) anti-MTBR tau (Alzheimer’s) Zeposia (MS) KarXT (Monotherapy SCZ) PDUFA Date: Sept. 26, 2024 KAR-2618 (Mood/anxiety) KarXT (Adjunctive SCZ) KarXT (ADP) KarXT (Alzheimer’s disease agitation) KarXT (bipolar I disorder) Potential to accelerate BMS entry in Alzheimer’s K K BMS NEUROSCIENCE PORTFOLIO PHASE 1 PHASE 2* REG / PHASE 3 K K K K K Karuna Therapeutics Other Early-Stage Opportunities (Autism, depression, mania, anxiety, and migraine – across clinical and preclinical assets) K Pre-Clinical Asset (confidential), Transitioning to Phase 1 K * Assets are Phase 2 ready Incremental opportunities Incremental opportunities TYK2-CNSi (MS) Transitioning to Phase 1 Transaction is expected to close in 1H 2024, subject to customary reviews

KarXT: Starting next year, opportunity for series of indications supporting continued growth Schizophrenia approval ~1.6M1 treated patients in the U.S. Adjunctive schizophrenia Phase 3 data Expansion within schizophrenia Alzheimer’s disease psychosis registrational data >6M2 people living with AD in U.S. Bipolar I Disorder registrational data Impacts ~1.4M1 patients in U.S. Alzheimer’s Disease Agitation registrational data >6M2 people living with AD in U.S. Pipeline and future indications 2024 2025 2026-2028 2029+ Long-acting injectable Source 2: “Alzheimer’s Disease Association Facts and Figures,” 2023. 7 Source 1: DRG – Clarivate, as of July 2023.

Karuna pipeline addresses neurological and psychiatric conditions Schizophrenia - adjunctive therapy (Registrational trial) Schizophrenia Alzheimer’s disease psychosis (Registrational acute and relapse prevention trials) Mood and anxiety disorders KarXT (xanomeline- trospium) (M1/M4 muscarinic agonist) KAR-2618 (TRPC4/5 inhibitor) Pre-Clinical Asset (confidential), Transitioning to Phase 1 Other Early-Stage Opportunities Reg. PIPELINE OVERVIEW KEY MILESTONES 2025 Topline data for ARISE 2026 Topline data from ADEPT-1 and ADEPT-2 Alzheimer’s disease agitation (Ph.3 ready) Bipolar I disorder (Ph.2 ready) Long-acting formulation P1 P2 P3 Potential to treat negative and cognitive symptoms in addition to positive symptoms of SCZ September 26, 2024 PDUFA date LEGEND In development by Karuna Therapeutics Bristol Myers Squibb plans to develop 10

KarXT: Potential first-in-class antipsychotic with unique MoA leading to differentiated efficacy and safety M1/M4 Unique 2-Drug Combination KarXT = Xanomeline + Trospium Xanomeline: Direct acting M1/M4 muscarinic agonist with potential to be effective in cholinergic deficient conditions Acts directly at muscarinic receptors with potential advantages over acetylcholine requiring PAMs e.g. in Alzheimer’s M1 agonism alongside M4 activity in KarXT could uniquely improve cognitive functions Trospium: peripheral muscarinic antagonist to reduce side-effects Compelling efficacy and safety in schizophrenia based on Phase 3 data Expected launch in schizophrenia in late 2024 Complementary MoA and differentiated safety support potential to be first approved adjunctive treatment in schizophrenia Opportunity to be first agent approved in Alzheimer's Disease Psychosis Patent protection through mid-2030s 10

KarXT in schizophrenia: Compelling efficacy and differentiated safety profile across three studies COMPELLING EFFICACY DIFFERENTIATED SAFETY PROFILE EMERGENT-1, 2 And 3 Trials of KarXT in Schizophrenia Primary endpoint: Change in baseline PANSS total score vs. placebo at Week 5 KarXT is not associated with common side effects of approved treatments, including weight gain, increase in prolactin levels, extrapyramidal symptoms, akathisia and/or sedation Discontinuation due to TEAEs was similar between KarXT and placebo Most common TEAEs were mild to moderate, with most being cholinergic and resolving over time with repeated dosing 10

Expansion opportunities supporting future growth 10 IN REGISTRATIONAL DEVELOPMENT BY KARUNA Adjunctive schizophrenia Alzheimer’s disease psychosis Need to improve on current SOC agents KarXT has complementary MoA with differentiated safety ARISE registrational trial underway No approved therapies Compelling data from Xanomeline alone Acts directly at muscarinic receptors unlike PAMs that require acetylcholine conditions Data expected 2025 M1 agonism alongside M4 activity in KarXT could uniquely improve cognition ADEPT registrational trials underway Data expected 2026 FUTURE INDICATIONS Alzheimer’s disease agitation Bipolar I disorder Xanomeline has demonstrated promising clinical data across symptomatology in Alzheimer’s disease M1/M4 activation believed to modulate dopamine mediated manic behaviors while preserving cognition

Indications currently in development comprise large patient populations and high unmet need 12 SCHIZOPHRENIA ALZHEIMER’S DISEASE PSYCHOSIS ~1.6M people1 in U.S. are treated for schizophrenia ~70% of patients on current therapies are not well managed >6M people2 in the U.S. living with Alzheimer’s disease Currently no approved trea Same physician call point a ~40% of diagnosed patients have psychosis tments for ADP s Alzheimer’s disease High unmet need for new option that provides strong efficacy, clean safety and ability to add onto existing medicines Potential first-in-disease treatment for ADP, an area with significant disease burden Source 1: DRG – Clarivate, as of July 2023. Source 2: “Alzheimer’s Disease Association Facts and Figures,” 2023.

KarXT’s benefit-risk profile is clearly differentiated 13 Risperidone1 Olanzapine2 Quetiapine IR3 Aripiprazole4 Lurasidone5 Brexpiprazole6 Cariprazine7 Lumateperone8 KarXT PANSS Placebo-subtracted difference -6.09 -8.95,10 -7.811 -8.8 -8.2 -6.5 -8.3 -5.0 -9.9 Effect size12 0.6 0.6 0.4 0.4 0.3 0.313 0.414 0.315 0.65 Weight increase >7% of weight short-term trials 21% 22% 23% 8% 5% 11% 8% 9%16 5.3% EPS 17% 32% 15% 13% 14% 5% 19% 7% 1.5% Sedation/ somnolence 10% 29% 18% 12% 17% 2% 8% 24% 4.7% Nausea 9% Not reported Not reported 15% 10% Not reported 7% 9% 17.1% Vomiting Not reported 4% 6% 11% 8% Not reported 5% 3% 10.9% All data come from the prescribing information except PANSS data for risperidone, olanzapine, and quetiapine IR as well as the weight for lumateperone. Pooled data for adverse events are shown when available; if unavailable, the highest incidence is reported. Data is used for reference and for illustrative purposes only; no head-to-head comparisons conducted. Sedation and somnolence data are shown as reported; if both were reported, they have been combined (aripiprazole and KarXT). Source: 1. Risperdal. Prescribing information. Janssen Pharmaceuticals, Inc.; 2022. 2. Zyprexa. Prescribing information. Eli Lilly and Company; 2021. 3. Seroquel. Prescribing information. AstraZeneca; 2009. 4. Abilify. Prescribing information. Otsuka Pharmaceutical Co., Ltd.; 2022. 5. Latuda. Prescribing information. Sunovion Pharmaceuticals Inc.; 2022. 6. Rexulti. Prescribing information. Otsuka Pharmaceutical Co., Ltd.; 2021. 7. Vraylar. Prescribing information. Allergan; 2022. 8. Caplyta. Prescribing information. Intra-Cellular Therapies, Inc.; 2022. 9. Lieberman JA, et al. Biol Psychiatry. 2016;79(12):952-961. 10. Lybalvi. Prescribing information. Alkermes, Inc.; 2021. 11. Seroquel XR. Prescribing information. AstraZeneca; 2022. 12. Leucht S, et al. Lancet. 2013;382(9896):951-962.13. Correll CU, et al. Schizophr Res. 2016;174(1-3):82-92. 14. Marder S, et al. Eur Neuropsychopharmacol. 2019;29(1):127-136. 15. Correll CU, et al. JAMA Psychiatry. 2020;77(4):349-358. 16. Kane JM, et al. International Clinical Psychopharmacology. 2021;36:244-250. KarXT data is pooled from EMERGENT 1-3. For illustrative purposes only. Drawn from several data sources. Cross-trial comparisons not intended

We have a robust go-to-market strategy 14 Patients & Caregivers HCPs: Psychiatry/NP /PAs/RNs Payers/ Medicaid/ Medicare Community Mental Health Centers Administrative Staff Building commercial readiness Patients Initially targeting patients who do not respond or cannot tolerate generic atypicals Key Prescribers Psychiatrists and psychiatry NPs, PAs, RNs Key Centers for Schizophrenia Private medical practices, community mental health centers and psychiatric institutions Integrated Approach Caregivers with patients State-Level Medicaid Strong patient support and local payer and advocacy Transaction is expected to close in 1H 2024, subject to customary reviews

Transaction Details Purchase price: $330.00/share in an all-cash transaction ~53% premium to closing share price as of Dec. 21, 2023 Total consideration: ~$14.0B implied transaction value, net of estimated cash of ~$12.7B Will fund transaction primarily with new debt Financial overview of the acquisition of Karuna Therapeutics 15 Significant opportunity for value creation for BMS, strengthening our presence in Neuroscience Deal Value KarXT: Financial Impact Closing expected 1H 2024 Expect ~$0.30 non-GAAP dilution/share in 2024, primarily from financing costs Maintain operating margin above 37% 2024 Guidance to be provided on Q4 2023 Earnings Call Capital Allocation No change to capital allocation priorities Retain capacity for additional business development Remain committed to the dividend Committed to maintaining strong investment grade rating − PDUFA Sept. 26, 2024 − Multi-billion-dollar sales potential − Opportunity for series of indications supporting continued growth Additional value from pipeline of assets See Forward-Looking Statements and Non-GAAP Financial Information. Transaction is expected to close in 1H 2024, subject to customary reviews

Q&A 16 Chris Boerner, Ph.D. Chief Executive Officer Adam Lenkowsky Executive Vice President, Chief Commercialization Officer David Elkins Executive Vice President, Chief Financial Officer Samit Hirawat, M.D. Executive Vice President, Chief Medical Officer, Global Drug Development Robert Plenge, M.D., Ph.D. Executive Vice President, Chief Research Officer, Head of Research Richard Hargreaves, Ph.D. Senior Vice President, Neuroscience Thematic Research Center

  1. The following are social media posts of BMS related to the potential acquisition of Karuna by BMS, published on December 22, 2023.

BMS-KRTX Social Media Posts

LinkedIn:

FOUND AT: https://www.linkedin.com/feed/update/urn:li:activity:7143936990932078592

Twitter/X:

FOUND AT: https://twitter.com/bmsnews/status/1738171282267541560

FOUND AT: https://twitter.com/bmsnews/status/1738171533141369340

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 state ments.

  1. The following is a transaction infographic related to the potential acquisition of Karuna by BMS, dated December 22, 2023.

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 Source: DRG – Clarivate, as of July 2023.

2 Source: Alzheimer’s Disease Association, 2023.

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.

  1. The following is a form of letter sent to clinical trial investigators on December 22, 2023.

Dear NAME,

I am excited to share that Bristol Myers Squibb announced an agreement to acquire Karuna Therapeutics, Inc., a biopharmaceutical company focused on delivering transformative medicines for people living with psychiatric and neurological conditions.

Karuna’s lead asset, KarXT, is an antipsychotic with a novel mechanism of action (MoA), which has resulted in a transformational profile in schizophrenia, with the potential to improve the lives of millions of patients who have limited to no treatment options. There are approximately 1.6 million 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. In clinical trials, KarXT has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments. Karuna’s New Drug Application (NDA) for KarXT for the treatment of schizophrenia has a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.

We also believe KarXT has promise to address additional areas of significant unmet medical need in the neuropsychiatric space. In addition to September’s PDUFA date, there are currently registrational trials underway evaluating KarXT as an adjunctive treatment in schizophrenia, and as a first-in-disease treatment for Alzheimer’s associated psychosis. BMS also sees potential for KarXT in multiple other indications, including Bipolar I disorder and Alzheimer’s disease agitation, as well as in Karuna’s early-stage and pre-clinical pipeline.

With Bristol Myers Squibb’s long-standing expertise in developing and commercializing medicines on a global scale, and legacy of success in neuroscience, we believe we will be well-positioned to ensure KarXT and the other assets in Karuna’s pipeline reach those living with these diseases.

In terms of next steps, we anticipate the transaction to close in the first half of 2024, subject to customary closing conditions. Until then, Bristol Myers Squibb and Karuna will continue to operate as separate and independent companies.

Your partnership is critical in advancing the science and development of our therapies, and we truly appreciate your continued role in helping us achieve success in our clinical development programs. As always, if you have any questions, please feel free to reach out to me.

On behalf of all of us at Bristol Myers Squibb, I wish you a happy and healthy holiday season.

Sincerely,

NAME

TITLE, Bristol Myers Squibb

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.

  1. The following is a form of letter sent to business partners on December 22, 2023.

Dear Valued Partner,

I am excited to share that Bristol Myers Squibb announced an agreement to acquire Karuna Therapeutics, Inc., a biopharmaceutical company focused on delivering transformative medicines for people living with psychiatric and neurological conditions.

Karuna’s lead asset, KarXT, is an antipsychotic with a novel mechanism of action (MoA), which has resulted in compelling efficacy and a differentiated safety profile, and we believe it has the potential to improve the lives of millions of patients who have limited to no treatment options. KarXT has a PDUFA date of September 26, 2024 for the treatment of schizophrenia in adults. In addition to September’s PDUFA date, there are currently registrational clinical trials underway evaluating KarXT as an adjunctive therapy in schizophrenia, and as a first-in-disease treatment for Alzheimer’s disease psychosis. Bristol Myers Squib sees potential for KarXT in multiple other indications, including Bipolar I disorder and Alzheimer’s disease agitation.

With Bristol Myers Squibb’s long-standing expertise in developing and commercializing medicines on a global scale, and legacy of success in neuroscience, we believe we will be well-positioned to ensure KarXT and the other assets in Karuna’s pipeline reach those living with these diseases.

Until the transaction closes, which we expect in the first half of 2024, subject to customary closing conditions, Bristol Myers Squibb and Karuna will continue to operate as separate and independent companies.

As a valued partner, you have been critical to helping us create an impact. We look forward to continuing to work with you to serve patients and drive our mutual success. As always, if you have any questions, please feel free to reach out to me.

On behalf of all of us at Bristol Myers Squibb, I wish you a happy and healthy holiday season.

Sincerely,

NAME

TITLE, Bristol Myers Squibb

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.

  1. The following is a form of letter sent to patient advocacy groups on December 22, 2023.

Dear NAME,

I am excited to share that Bristol Myers Squibb announced an agreement to acquire Karuna Therapeutics, Inc., a biopharmaceutical company focused on delivering transformative medicines for people living with psychiatric and neurological conditions.

Karuna’s lead asset, KarXT, is an antipsychotic with a novel mechanism of action (MoA), which has resulted in a transformational profile in schizophrenia, with the potential to improve the lives of millions of patients who have limited to no treatment options. A significant portion of people with schizophrenia do not respond to currently available therapies and experience unacceptable side effects. In clinical trials, KarXT has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments. Karuna’s New Drug Application (NDA) for KarXT for the treatment of schizophrenia has a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.

We also believe KarXT has promise to address additional areas of significant unmet medical need in the neuropsychiatric space. In addition to September’s PDUFA date, there are currently registrational trials underway evaluating KarXT as an adjunctive therapy in schizophrenia, and as a first-in-disease treatment for Alzheimer’s associated psychosis, for which there are currently no approved treatments. Bristol Myers Squibb also sees potential for KarXT in multiple other indications, including Bipolar I disorder and Alzheimer’s disease agitation, as well as in Karuna’s early-stage and pre-clinical pipeline.

With Bristol Myers Squibb’s long-standing expertise in developing and commercializing medicines on a global scale, and legacy of success in neuroscience, we believe we will be well-positioned to ensure KarXT and the other assets in Karuna’s pipeline reach those living with these diseases.

In terms of next steps, we expect the transaction to close in the first half of 2024, subject to customary closing conditions. Until then, Bristol Myers Squibb and Karuna will continue to operate as separate and independent companies.

We appreciate all you do to advocate for patients and look forward to our continued partnership. As always, please feel free to reach out to me with any additional questions.

On behalf of all of us at Bristol Myers Squibb, I wish you a happy and healthy holiday season.

Sincerely,

NAME

TITLE, Bristol Myers Squibb

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.

  1. The following is a form of letter sent to regulators on December 22, 2023.

Dear NAME,

I am excited to share that Bristol Myers Squibb announced an agreement to acquire Karuna Therapeutics, Inc., a biopharmaceutical company focused on delivering transformative medicines for people living with psychiatric and neurological conditions.

Karuna’s lead asset, KarXT, is an antipsychotic with a novel mechanism of action (MoA), which has resulted in a transformational profile in schizophrenia, with the potential to improve the lives of millions of patients who have limited to no treatment options. A significant portion of people with schizophrenia do not respond to currently available therapies and experience unacceptable side effects. In clinical trials, KarXT has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments. Karuna’s New Drug Application (NDA) for KarXT for the treatment of schizophrenia has a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.

We also believe KarXT has promise to address additional areas of significant unmet medical need in the neuropsychiatric space. In addition to September’s PDUFA date, there are currently registrational trials underway evaluating KarXT as an adjunctive therapy in schizophrenia, and as a first-in-disease treatment for Alzheimer’s associated psychosis. Bristol Myers Squibb also sees potential for KarXT in multiple other indications, including Bipolar I disorder, and Alzheimer’s disease agitation, as well as in Karuna’s early-stage and pre-clinical pipeline.

With Bristol Myers Squibb’s long-standing expertise in developing and commercializing medicines on a global scale, and legacy of success in neuroscience, we believe we will be well-positioned to ensure KarXT and the other assets in Kodiak’s pipeline reach those living with these diseases.

We expect the transaction to close in the first half of 2024, subject to customary closing conditions. Until then, Bristol Myers Squibb and Karuna will continue to operate as separate and independent companies.

We value our relationship and appreciate your support. As always, please feel free to reach out to me with any additional questions.

On behalf of all of us at Bristol Myers Squibb, I wish you a happy and healthy holiday season.

Sincerely,

NAME

TITLE, Bristol Myers Squibb

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.

Talk to a Data Expert

Have a question? We'll get back to you promptly.