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<h4>Resolution Details</h4>
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<strong>Company:</strong>
<p>Bristol-Myers Squibb Company</p>
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<strong>Year:</strong>
<p>2026 </p>
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<strong>Issue Area:</strong>
<p>Corporate Governance </p>
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<strong>Focus Area:</strong>
<p>Independent Board Chairs </p>
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<strong>Status:</strong>
<p>Filed</p>
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<h2>Resolution Text</h2>
<p><strong>RESOLVED</strong>: Shareholders request that the Board of Directors adopt an enduring policy, and amend the governing documents as necessary in order that 2 separate people hold the office of the Chairman and the office of the CEO as soon as possible.</p>
<p><strong>SUPPORTING STATEMENT</strong>:&nbsp;</p>
<p dir=”ltr”>The Chairman of the Board shall be an Independent Director. A Lead Director shall not be a substitute for an independent Board Chairman.<br>&nbsp;<br>The Board shall have the discretion to select an interim Chairman of the Board, who is not an Independent Director, to serve while the Board is required to seek an Independent Chairman of the Board on an accelerated basis. This policy could be phased in when there is a contract renewal for our current CEO or for the next CEO transition although it is better to adopt it now.</p>
<p dir=”ltr”>An independent Board Chairman&nbsp;at all times improves corporate governance by bringing impartiality, objective oversight, and external expertise to board decisions, mitigating conflicts of interest, enhancing transparency, and boosting shareholder confidence.&nbsp;</p>
<p dir=”ltr”>This detached perspective allows the chairman to focus on&nbsp;shareholder interests,&nbsp;strengthen management accountability, and provide critical checks and balances, ultimately contributing to long-term sustainability and credibility.&nbsp;</p>
<p dir=”ltr”>This may be a particularly good time to consider the merits of this proposal. Bristol-Myers Squibb stock was at $77 in 2016 and fell to $43 in late 2025 despite a robust stock market.</p>
<p dir=”ltr”>Unfavorable news reports regarding Bristol-Myers Squibb emerged in 2025.&nbsp;</p>
<p dir=”ltr”>There were disappointing drug trial results:<br>• Cobenfy for schizophrenia:&nbsp;In April 2025, a Phase 3 trial showed that the schizophrenia drug Cobenfy failed to significantly improve symptoms when used as an add-on therapy.&nbsp;<br>• Mavacamten for heart disease:&nbsp;A late-stage study released in April 2025 indicated that the heart disease drug Mavacamten failed to meet its primary goals.&nbsp;<br>• Reblozyl for anemia:&nbsp;A Phase 3 study for Reblozyl in patients with myelofibrosis-associated anemia failed to meet its primary endpoint in July 2025. This was the fourth failed pivotal trial of the year for BMY.<br><br>Sales from BMY’s legacy drug portfolio, including cancer treatment Revlimid, have been negatively impacted by growing generic competition. Revlimid sales alone plunged 38% in the first half of 2025.&nbsp;<br><br>A federal appeals court rejected BMY’s and Janssen’s legal challenge to the Medicare drug price negotiation program in September 2025. The program is expected to drive down drug prices for Medicare beneficiaries, a development that is unfavorable for companies like BMY.&nbsp;<br><br>In July 2025, BMY lowered its full-year earnings per share forecast, citing a charge related to a partnership with BioNTech. This came after lowering the 2025 outlook earlier in the year.<br><br>BMY accumulated significant debt to fund its strategy of acquiring companies with promising drugs. As of mid-2025, the company’s long-term debt stood at $44 billion. BMY’s stock lost momentum throughout 2025. It slipped below key moving averages, signaling a bearish shareholder reaction.</p>

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<div class=”views-field views-field-nothing”><span class=”field-content”> John Chevedden</span></div><div class=”views-field views-field-title views-field-field-shareholder”><span class=”field-content”>Chevedden Corporate Governance</span></div>
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<h4>Resolution Details</h4>
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<strong>Company:</strong>
<p>Bristol-Myers Squibb Company</p>
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<strong>Year:</strong>
<p>2025 </p>
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<strong>Issue Area:</strong>
<p>Health, Lobbying &amp; Political Contributions </p>
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<strong>Focus Area:</strong>
<p>Global Health, Lobbying, Pharma Lobbying/Political Contributions </p>
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<strong>Status:</strong>
<p>Filed</p>
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<h2>Resolution Text</h2>
<p>Shareholders request the preparation of a report, updated annually, disclosing:&nbsp;</p>
<p>1.&nbsp;&nbsp;&nbsp;&nbsp;Company policy and procedures governing lobbying, both direct and indirect, and grassroots lobbying communications.<br>2.&nbsp;&nbsp;&nbsp;&nbsp;Payments by BMS used for (a) direct or indirect lobbying or (b) grassroots lobbying communications, in each case including the amount of the payment and the recipient.<br>3.&nbsp;&nbsp;&nbsp;&nbsp;BMS’s membership in and payments to any tax-exempt organization that writes and endorses model legislation.<br>4.&nbsp;&nbsp;&nbsp;&nbsp;Description of management’s decision-making process and the Board’s oversight for making payments described in section 2 above.</p>
<p>For purposes of this proposal, a “grassroots lobbying communication” is a communication directed to the general public that (a) refers to specific legislation or regulation, (b) reflects a view on the legislation or regulation and (c) encourages the recipient of the communication to take action with respect to the legislation or regulation. “Indirect lobbying” is lobbying engaged in by a trade association or other organization of which BMS is a member.&nbsp;<br>&nbsp;</p>
<p>Both “direct and indirect lobbying” and “grassroots lobbying communications” include efforts at the local, state and federal levels.&nbsp;<br>&nbsp;</p>
<p>The report shall be presented to the Committee on Directors and Corporate Governance and posted on BMS’s website.&nbsp;<br>&nbsp;</p>
<p>Supporting Statement&nbsp;<br>Full disclosure of BM S’s lobbying activities and expenditures is needed to assess whether BMS’s lobbying is consistent with its expressed goals and stockholder interests. BMS spent $61 million from 2010- 2023 on federal lobbying. BMS also lobbies at the state level, spending over $1.9 million on lobbying in California from 2010 – 2023. And BMS lobbies abroad, spending between €1,000,000 – 1,249,999 on lobbying in Europe for 2023.&nbsp;<br>&nbsp;</p>
<p>Companies can give unlimited amounts to third party groups that spend millions on lobbying and undisclosed grassroots activity. 1 BMS sits on the boards of the Chamber of Commerce and the Pharmaceutical Research and Manufacturers of America (PhRMA), which together have spent over $2.4 billion on lobbying since 1998. BMS’s trade association disclosure leaves out many memberships in trade associations that lobby, like Biocom California, the Healthcare Distribution Alliance, Healthcare Institute of New Jersey and MassBio. And unlike peer Biogen, BMS’s disclosure critically leaves out its payments to social welfare groups, including the Alliance for Patient Access (AfPA), Alliance for Regenerative Medicine, Bay Area Council, Caregiver Action Network and Public Affairs Council.&nbsp;<br>&nbsp;</p>
<p>BMS’s lack of disclosure presents reputational risk when its lobbying contradicts company public positions. On company positions, BMS states it is committed to providing access to its prescription medicines at fair prices, yet PhRMA sued the federal government’s plan to negotiate Medicare drug prices.2 And BMS funds AfPA, a social welfare group which<br>”claims to be pro-consumer but consistently advocates against policies to lower drug prices”3 and is described as a foil “for the pharmaceutical industry instead of advancing patient interests.”4&nbsp;<br>&nbsp;</p>
<p>Improved Bristol-Myers lobbying disclosure will protect the reputation of Bristol-Myers and preserve shareholder value.&nbsp;</p>
<p>1 https :/ /theintercept.com/2 0 I 9 /0 8/06/bus i ness-grou p-spend i ng-on-lobbying-in-wash i ngton-is-at-1 east-dou b le-whats-pub I icly­<br>reported/.&nbsp;<br>2 https ://www. centraloregondai ly .com/news/nati on-wor Id/ drugm aker-lob by i ng-group-sues-over-p Ian-to-negotiate-med icare-drug­<br>prices/ article_ ce2e7741-a721-5875-8f01-f09785144e64.htm l?=/&amp;subcategory=615% 7CCraft+Fairs;&nbsp;<br>https://news.bloomberglaw.com/health-law-and-business/phrma-to-revive-medicare-drug-price-lawsuit-before-fifth-circuit.&nbsp;<br>3 https://prospect.org/power/astroturf-campaign-attacks-discount-drug-program-for-poor/.&nbsp;<br>4 https://apnews.com/article/7c8d0728c38345cd8dfc0fe I abd456ae.&nbsp;</p>

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<div class=”views-field views-field-nothing”><span class=”field-content”> John Chevedden</span></div><div class=”views-field views-field-title views-field-field-shareholder”><span class=”field-content”>Chevedden Corporate Governance</span></div>
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<h4>Resolution Details</h4>
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<strong>Company:</strong>
<p>Bristol-Myers Squibb Company</p>
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<strong>Year:</strong>
<p>2025 </p>
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<strong>Issue Area:</strong>
<p>Finance </p>
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<strong>Focus Area:</strong>
<p>Corporate Taxation, Corporate Taxation/Policies, Tax Havens </p>
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<strong>Status:</strong>
<p>Filed</p>
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<h2>Resolution Text</h2>
<p><strong>RESOLVED</strong>: Bristol-Myers Squibb (BMY) shareholders request the Board of Directors issue a tax transparency report to shareholders, at reasonable expense and excluding confidential information, prepared in consideration of the indicators and guidelines outlined in the Global Reporting Initiative’s (GRI) Tax Standard.</p>
<p><strong>Supporting Statement&nbsp;</strong></p>
<p>BMY’s tax practices and failure to disclose has harmed our company’s reputation, resulting in an investigation into whether BMY was using an “abusive” tax shelter that would cheat the United States out of $1.4 billion in taxes.1 Tax transparency is required to restore BMY’s reputation and prevent future losses.&nbsp;</p>
<p>BMY does not disclose revenues or profits in non-US markets, and foreign tax payments are not disaggregated, challenging investors’ ability to evaluate the risks to BMY of taxation reforms or whether BMY is engaged in responsible tax practices that ensure long-term value creation. BMY’s alleged profit shifting to Ireland is central to current scrutiny involving its tax practices.2&nbsp;</p>
<p>Global OECD tax reforms are now implemented worldwide. There are growing demands for the United Nations to play a stronger role, ensuring multinationals pay taxes where profits are earned. The Financial Accounting Standards Board adopted new reporting requirements on tax payments, effective in 2025. A European Union directive to implement country-by-country reporting (CbCR) is effective in 2024.3 Similar legislation is expected in Australia in the same timeframe.&nbsp;</p>
<p>Unchecked corporate tax avoidance poses a risk to the long-term portfolios of diversified investors. While such activities may help one company, they can cause externalities for other companies, taxpayers, consumers, and workers — ultimately hampering economic value creation and portfolio growth upon which long-term diversified investors depend.4</p>
<p>The GRI Standards is the world’s most utilized reporting standard, actively supported by global investors representing over $10 trillion.5 The GRI Tax Standard was developed in response to investor concerns regarding the lack of corporate tax transparency and the impact of tax avoidance on governments’ ability to fund services and support sustainable development.6 It is the first comprehensive, global standard for public tax disclosure. It requires public reporting of a company’s business activities, including revenues, profits and losses, and tax payments within each jurisdiction.7&nbsp;</p>
<p>Profit shifting by corporations is estimated to cost the US government $70 – 100 billion annually.8 The OECD estimates annual revenue losses of $100 – 240 billion globally.9 The PRI states that tax avoidance is a key driver of global inequality.10 Further reforms and greater international scrutiny of BMY’s tax practices will continue to put shareholders at risk without greater transparency.&nbsp;</p>
<p>This proposal would bring BMY’s disclosures in line with leading companies using the Tax Standard.11 The reporting burden is negligible, since BMY already reports similar confidential CbCR information shared with OECD tax authorities.</p>
<p>1https://www.nytimes.com/2021/04/01/business/bristol-myers-taxes-irs.html</p>
<p>2https://www.investigate-europe.eu/posts/deadly-prices-pharma-firms-stash-profits-in-europes-tax-havens-as-patients struggle-with-drug-prices</p>
<p>3https://www.internationaltaxreview.com/article/b1vf7yc65qpzcd/this-week-in-tax-eu-on-track-for-public-cbcr-by-2023&nbsp;</p>
<p>4https://theshareholdercommons.com/wp-content/uploads/2024/09/Sample-Text_Portfolio-focused-Proxy Actions_2024September.pdf&nbsp;</p>
<p>5https://assets.kpmg/content/dam/kpmg/xx/pdf/2020/11/the-time-has-come.pdf 6https://www.globalreporting.org/about-gri/news-center/backing-for-gri-s-tax-standard/ 7https://www.globalreporting.org/standards/standards-development/topic-standard-for-tax/ 8https://thefactcoalition.org/trillions-at-stake-behind-the-numbers-at-play-in-u-s-international-corporate-tax-reform/&nbsp;</p>
<p>9https://www.washingtonpost.com/us-policy/2020/11/19/global-tax-evasion-data/&nbsp;</p>
<p>10 https://www.globalreporting.org/about-gri/news-center/backing-for-gri-s-tax-standard/&nbsp;</p>
<p>11 https://www.globalreporting.org/about-gri/news-center/momentum-gathering-behind-public-country-by-country-tax reporting/</p>
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<div class=”views-field views-field-nothing”><span class=”field-content”> James McRitchie</span></div><div class=”views-field views-field-title views-field-field-shareholder”><span class=”field-content”>Corporate Governance</span></div>
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Resolution Details

Company:

Bristol-Myers Squibb Company

Year:

2024

Issue Area:

Corporate Governance

Focus Area:

Shareholder Rights

Status:

Withdrawn for Agreement

Resolution Text

RESOLVED

Shareholders request the Board of Directors adopt and disclose a policy stating how it will exercise its discretion to treat shareholders’ nominees for board membership equitably and avoid encumbering such nominations with unnecessary administrative or evidentiary requirements.

SUPPORTING STATEMENT

In the view of the proponent, the Board should consider exercising its discretion under the proposed policy toward ensuring that paperwork requirements governing the nomination and election of directors should generally treat shareholder and Board nominees equitably; requirements regarding endorsements and solicitations should not unnecessarily encumber the nomination process.

Consideration should also be given under the policy to repealing any advance notice bylaw provisions imposing additional requirements inconsistent with this proposal, unless legally required, such as those requiring:

· Nominating shareholders be shareholders of record, rather than beneficial owners;

· Nominees submit questionnaires regarding background and qualifications (other than as required in the Company’s certificate of incorporation or bylaws);

· Nominees submit to interviews with the Board or any committee thereof;

· Shareholders or nominees provide information that is already required to be publicly disclosed under applicable law or regulation; and

· Excessive or inappropriate levels of disclosure regarding nominees’ eligibility to serve on the Board, the nominees’ background, or experience.

The legitimacy of Board power to oversee the executives of Bristol-Myers Squibb Company (Company) rests on the power of shareholders to elect directors:1 [T]he unadorned right to cast a ballot in a contest for [corporate] office . . . is meaningless without the right to participate in selecting the contestants… To allow for voting while maintaining a closed candidate selection process thus renders the former an empty exercise.”2

Burdening shareholder nominees can entrench incumbent directors and management. Laws and regulations overseen and enforced by the U.S. Securities and Exchange Commission, a neutral third party, ensure shareholders have pertinent information on nominating shareholders and nominees before executing proxies,3

Advance notice bylaws can create hurdles for shareholders exercising their rights and can be used to conduct “fishing expeditions” to which board nominees are not subject.

These practices delegitimize corporate activity because directors work on behalf of shareholders, who should be able to replace their own fiduciaries. Company interference in this process is especially dangerous because financial theory recommends that most shareholders diversify their portfolios.

Such diversified investors have an interest in ensuring our Company does not profit from practices that threaten social and environmental systems upon which diversified portfolios depend.4 Company directors influenced by executives, in contrast, may prioritize Company profitability over systems that are of critical importance to shareholders.5

Accordingly, giving Company directors a gatekeeper role through a burdensome unequal nomination process threatens the interests of shareholders to nominate candidates free of management influence.

Fair Treatment of Shareholder Nominees – Vote FOR Proposal [4*]

1 https://ssrn.com/abstract=4565395 

2 https://casetext.com/case/durkin-v-national-bank-of-olyphant 

3 https://www.ecfr.gov/current/title-17/chapter-II/part-240/subpart-A/subject-group- ECFR8c9733e13b955d6/section-240.14a-101

4 https://theshareholdercommons.com/wp-content/uploads/2022/09/Climate-Change-Case-Study-FINAL.pdf 

5 https://ssrn.com/abstract=4056602 

 

 

Resolution Details

Company:

Bristol-Myers Squibb Company

Year:

2024

Issue Area:

Health, Human Rights & Worker Rights

Focus Area:

Access & Affordability, Human Rights Policy, Pharmaceutical Prices and Access

Status:

Withdrawn for Agreement

Resolution Text

RESOLVED, that shareholders of Bristol-Myers Squibb Company (“BMS” or the “Company”) urge the board of directors to adopt a comprehensive human rights policy, referencing internationally recognized human rights standards, that applies to both its own operations and its suppliers that includes the right to the highest attainable standard of physical and mental health and establishes a process to identify, prevent, mitigate, and remedy adverse human rights impacts, above and beyond supplier audits, including consultation with stakeholders. 

SUPPORTING STATEMENT

BMS currently has a “Position on Human Rights” (“Position”), which states that BMS “fully supports the principles established under the United Nations Universal Declaration of Human Rights and the International Labour Organization Declaration on Fundamental Principles and Rights at Work.”[1] BMS also has issued Standards of Business Conduct and Ethics for Third Parties (the “Standards”) in which the Company sets forth expectations for suppliers. Neither the Position nor the Standards mentions the human right to health–“the right of everyone to the enjoyment of the highest attainable standard of physical and mental health”—as recognized in Article 12.1 of the International Covenant on Economic, Social, and Cultural Rights (“ICESCR”)[2] 

Access to medicines is a key component of the right to health.[3] Target 3.8 of Sustainable Development Goal 3 assesses progress toward “access to safe, effective, quality and affordable essential medicines and vaccines for all.”[4] The UN Special Rapporteur on the Right to Health has made clear that responsibility for increasing access to medicines is shared between states and pharmaceutical firms[5] and recommends that firms “should adopt a human rights policy statement which expressly recognises the importance of human rights generally, and the right to the highest attainable standard of health in particular.”[6] Novartis has adopted a human rights commitment statement that incorporates the right to health, including access to medicine, and references the ICRSCR.[7] BMS, as a global pharmaceutical firm, should do so as well.

Although BMS has disclosed information about its access programs[8] and management systems,[9] it does not explain in the Position or Standards how it implements its support for human rights. A process to identify, prevent, mitigate, and remedy adverse human rights impacts–”human rights due diligence” defined by the U.N. Guiding Principles on Business and Human Rights–is a key part of a comprehensive human rights policy. The Pharmaceutical Supply Chain Initiative Principles, which BMS says it supports,[10] contemplate supplier audits,[11] whose effectiveness has been questioned.[12]  Including a human rights due diligence process in its human rights policy, as Novartis has done,[13] would enable BMS to identify potential impacts before they occur, track its human rights performance, and embed human rights in its operations.

[1]  https://www.bms.com/about-us/sustainability/social-progress/human-rights.html

[2] www.ohchr.org/en/instruments-mechanisms/instruments/international-covenant-economic-social-and-cultural-rights; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605313/

[3]  https://www.hsph.harvard.edu/wp-content/uploads/sites/580/2012/10/marks_access_to_essential_medecines-2009.pdf

[4] www.un.org/en/development/desa/population/migration/generalassembly/docs/globalcompact/A_RES_70_1_E.pdf

[5] https://documents-dds-ny.un.org/doc/UNDOC/GEN/N06/519/97/PDF/N0651997.pdf?OpenElement, paras. 82-93.

[6] https://www.ohchr.org/Documents/Issues/Health/GuidelinesForPharmaceuticalCompanies.doc

[7] https://www.novartis.com/sites/novartiscom/files/novartis-human-rights-commitment-statement.pdf

[8]  https://www.bms.com/patient-and-caregivers/get-help-paying-for-your-medicines.html; https://www.bms.com/about-us/responsibility/position-on-key-issues/pricing.html; https://www.bms.com/assets/bms/us/en-us/pdf/bmy-2021-esg-report.pdf, at 23.

[9]  https://www.bms.com/assets/bms/us/en-us/pdf/standards/English-3PStandards.pdf

[10]  https://www.bms.com/about-us/sustainability/social-progress/our-suppliers.html

[11] https://pscinitiative.org/sharedAudits

[12] https://www.ajsosteniblebcn.cat/human-rights-due-diligence-in-global-supply-chains_28919.pdf, at 14; https://shiftproject.org/resource/from-audit-to-innovation-advancing-human-rights-in-global-supply-chains/, at 8

[13] https://www.novartis.com/sites/novartiscom/files/novartis-human-rights-commitment-statement.pdf

 

Resolution Details

Company:

Bristol-Myers Squibb Company

Year:

2023

Issue Area:

Corporate Governance, Health

Focus Area:

Executive Compensation, Opioids

Status:

Withdrawn for Agreement

Vote Percentage:

Resolution Text

RESOLVED that shareholders of Bristol-Myers Squibb Company (“Bristol-Myers” or “the Company”) urge the Board of Directors to adopt a policy that no financial performance metric shall be adjusted to exclude Legal or Compliance Costs when evaluating performance for purposes of determining the amount or vesting of any senior executive Incentive Compensation award. “Legal or Compliance Costs” are expenses or charges associated with any investigation, litigation or enforcement action related to drug manufacturing, sales, marketing or distribution, including legal fees; amounts paid in fines, penalties or damages; and amounts paid in connection with monitoring required by any settlement or judgement of claims of the kind described above. “Incentive Compensation” is compensation paid pursuant to short-term and long-term incentive compensation plans and programs. The policy should be implemented in a way that does not violate any existing contractual obligation of the Company or the terms of any compensation or benefit plan. The Board shall have discretion to modify the application of this policy in specific circumstances for reasonable exceptions and in that case shall provide a statement of explanation.

SUPPORTING STATEMENT: The Investors for Opioid and Pharmaceutical Accountability (IOPA), a coalition of 67 investors with $4.2 trillion in assets under management has been engaging companies on issues of good corporate governance for several years. As shareholders bear the financial impacts of legal settlements related to inadequate assessment of how business decisions would impact possible litigation, the IOPA believes executives should similarly be accountable for the financial impacts of those decisions.

Bristol-Myers (BMS) adjusts certain financial metrics when calculating progress for executive incentive compensation. While some adjustments may be appropriate, we believe senior executives should not be insulated from all legal costs as a matter of policy.

These considerations are especially critical for pharmaceutical companies because of the industry’s high legal and regulatory risks related to product safety and the industry’s commercial practices. BMS, in particular, is facing several concerning lawsuits, including:

A $6.4 billion class action lawsuit filed on behalf of former shareholders of Celgene Corporation who received Contingent Value Rights for violations of the federal securities laws.[1]
A $75 Million, plus interest, settlement to resolve allegations that it knowingly underpaid rebates owed under the Medicaid Drug Rebate Program[2]
$11 million to settle a lawsuit that accused several drugmakers of conspiring to block generic competition to HIV medicines.[3]

Companies that opt to align the interests of executive and shareholders through the structure of the executive compensation plan sever that alignment when litigation is simply cherry picked out of the calculation. Some firms have chosen to address this issue by voluntarily reducing CEO pay in response to large litigation fees. For example, following discussions with the IOPA and other shareholders, AmerisourceBergen, Cardinal Health, and McKesson reduced CEO pay in light of opioid-related litigation settlements. While the IOPA views the amounts of the reductions as less than warranted, we applaud the decision to acknowledge that incentives matter. We urge shareholders to vote for this proposal.

[1] https://www.fiercepharma.com/pharma/bristol-myers-loses-bid-toss-64-billion-cvr-lawsuit-tied-celgene-takeover-breyanzi-approval

[2] https://www.justice.gov/usao-edpa/pr/bristol-myers-squibb-pay-75-million-resolve-false-claims-act-allegations-underpayment

[3] https://www.statnews.com/pharmalot/2022/04/14/bristol-gilead-hiv-aids-antitrust/

  

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Resolution Details

Company:

Bristol-Myers Squibb Company

Year:

2023

Issue Area:

Health

Focus Area:

Anti-Competitive Practices, Pharmaceutical Patents, Pharmaceutical Prices and Access

Status:

Withdrawn

Vote Percentage:

Resolution Text

RESOLVED, that shareholders of the Bristol-Myers Squibb Company (“BMY”) ask the Board of Directors to establish and report on a process by which the impact of extended patent exclusivities on product access would be considered in deciding whether to apply for secondary and tertiary patents. Secondary and tertiary patents are patents applied for after the main active ingredient/molecule patent(s) and which relate to the product. The report on the process should be prepared at reasonable cost, omitting confidential and proprietary information, and published on BMY’s website.

SUPPORTING STATEMENT: Access to medicines, especially costly specialty drugs, is the subject of widespread public debate in the U.S. A 2021 Rand analysis concluded that U.S. prices for branded drugs were nearly 3.5 times higher than prices in 32 OECD member countries.1 The Kaiser Family Foundation has “consistently found prescription drug costs to be an important health policy area of public interest and public concern.”2

This high level of concern has driven policy responses. The Inflation Reduction Act empowers the federal government to negotiate some drug prices.3 State measures, including drug price transparency legislation and copay caps, have also been adopted.4 The House Committee on Oversight and Reform (the “Committee”) launched a far-reaching investigation into drug pricing in January 2019.5

Intellectual property protections on branded drugs play an important role in maintaining high prices and impeding access. When a drug’s patent protection ends, generic manufacturers can enter the market, reducing prices. But branded drug manufacturers may try to delay competition by extending their exclusivity periods.

Among the abuses described by the Committee’s December 2021 report is construction of a “patent thicket,” which consists of many “secondary patents covering the formulations, dosing, or methods of using, administering, or manufacturing a drug”; they are granted after the drug’s primary patent, covering its main active ingredient or molecule, has been granted.6 In June 2022, citing the impact of patent thickets on drug prices, a bipartisan group of Senators urged the U.S. Patent and Trademark Office to “take regulatory steps to . . . eliminate large collections of patents on a single invention.”

The Committee reported that 109 patents have been granted for BMY’s Revlimid, extending its exclusivity period to 40 years.7 Although two “copycat” drugs for BMY’s Eliquis blood-thinner were FDA approved in 2019, BMY and partner Pfizer “erected a patent wall”8 to defend exclusivity. In 2021, they prevailed in litigation, winning exclusivity until 20289 and effectively forestalling competition by 7.7 years compared to the European market.10

In our view, a process that considers the impact of extended exclusivity periods on patient access would ensure that BMY considers not only whether it can apply for secondary and tertiary patents but also whether it should do so. BMY’s current approach subjects the company to reputational risks and further regulatory blowback resulting from high drug prices and perceptions regarding abusive patenting practices.

1 https://www.rand.org/news/press/2021/01/28.html

2 https://www.kff.org/health-costs/poll-finding/public-opinion-on-prescription-drugs-and-their-prices/

3 https://www.kff.org/medicare/issue-brief/explaining-the-prescription-drug-provisions-in-the-inflation-reduction-act/

4 https://www.americanprogress.org/article/state-policies-to-address-prescription-drug-affordability-across-the-supply-chain/

5 https://oversight.house.gov/sites/democrats.oversight.house.gov/files/DRUG%20PRICING%20REPORT%20WITH%2 0APPENDIX%20v3.pdf, at i.

6 https://oversight.house.gov/sites/democrats.oversight.house.gov/files/DRUG%20PRICING%20REPORT%20WITH%2 0APPENDIX%20v3.pdf, at 79.

7 https://oversight.house.gov/sites/democrats.oversight.house.gov/files/DRUG%20PRICING%20REPORT%20WITH%2 0APPENDIX%20v3.pdf, at 80.

8 https://www.fiercepharma.com/pharma/first-generics-to-bristol-myers-and-pfizer-s-eliquis-are-here-but-might-not-launch-until

9 https://news.bms.com/news/details/2021/The-Bristol-Myers-Squibb-Pfizer-Alliance-is-pleased-with-the-decision-by-the-U.S.-Court-of-Appeals-for-the-Federal-Circuit-upholding-the-Eliquis-Patents/default.aspx

10 https://money.usnews.com/investing/news/articles/2022-09-15/consumer-group-says-drugmakers-abuse-u-s-patent-system-to-keep-prices-high

  

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