Bristol Myers Squibb Reports First Quarter Financial Results for 2023

• Reports First Quarter Revenues of $11.3 Billion
• Posts First Quarter GAAP Earnings Per Share of $1.07 and Non-GAAP EPS of $2.05; Includes Net Impact of ($0.01) Per Share for GAAP and Non-GAAP EPS Due to Acquired IPRD Charges and Licensing Income
• Delivers Strong Revenue Growth of 8% from In-Line Products and New Product Portfolio; or 10% When Adjusted for Foreign Exchange
• Further Advances Portfolio Renewal Strategy, Achieving Important Milestones Across Therapeutic Areas
• Adjusts GAAP 2023 EPS Guidance; Affirms Non-GAAP Financial Guidance for 2023

Bristol Myers Squibb (NYSE:BMY) today reports results for the first quarter of 2023, which reflect robust in-line and new product portfolio growth, strong commercial execution and continued advancement of the product pipeline.

“Our strong execution resulted in double-digit revenue growth for our in-line products and new product portfolio,” said Giovanni Caforio, M.D., board chair and chief executive officer, Bristol Myers Squibb. “We continue to successfully execute against our key strategic priorities and meaningfully advance our portfolio renewal strategy, achieving important regulatory and clinical milestones that will benefit patients with serious unmet needs. We remain focused on commercial execution, progressing our pipeline and leveraging our strong financial foundation to invest in the next wave of innovation and deliver value to all of our stakeholders.”

FIRST QUARTER FINANCIAL RESULTS

All comparisons are made versus the same period in 2022 unless otherwise stated.

• Bristol Myers Squibb posted first quarter revenues of $11.3 billion, a decrease of 3%, due to Revlimid generic erosion and foreign exchange impacts, partially offset by in-line products (primarily Opdivo and Eliquis) and our new product portfolio (primarily Opdualag, Abecma and Reblozyl). When adjusted for foreign exchange, revenues decreased 1%. Our revenues for in-line products and new product portfolio increased 8% to $9.3 billion, or 10% when adjusted for foreign exchange impacts.
• U.S. revenues increased 4% to $8.0 billion in the quarter primarily due to Eliquis, Opdivo and our new product portfolio, partially offset by Revlimid generic erosion. International revenues decreased 16% to $3.3 billion in the quarter. When adjusted for foreign exchange impacts, international revenues decreased 11%, primarily due to Revlimid and Eliquis generic erosion, partially offset by Opdivo and our new product portfolio.
• On a GAAP basis, gross margin decreased from 78.8% to 77.4% and on a non-GAAP basis, decreased from 79.2% to 77.8% primarily due to product mix, partially offset by foreign exchange impacts and related hedging settlements.
• On a GAAP and non-GAAP basis, marketing, selling and administrative expenses decreased 4% to $1.8 billion in the quarter, primarily due to differences of timing of spend compared to the prior year and foreign exchange impacts, partially offset by higher costs to support new product launches.
• On a GAAP and non-GAAP basis, research and development expenses increased 3% in the quarter, primarily due to higher costs to support the overall portfolio.
• On a GAAP and non-GAAP basis, Acquired IPRD decreased to $75 million in the current quarter from $333 million in the same period a year ago. On a GAAP and non-GAAP basis, licensing income decreased to $43 million in the current quarter from $52 million in the same period a year ago.
• On a GAAP basis, amortization of acquired intangible assets decreased 7% to $2.3 billion in the quarter, primarily due to the Abraxane marketed product right being fully amortized in the fourth quarter of 2022.
• On a GAAP basis, effective tax rate changed from 23.9% to 18.2% in the quarter primarily due to jurisdictional earnings mix resulting from specified items and the release of income tax reserves in the first quarter of 2023, partially offset by changes to our Puerto Rico tax decree. On a non-GAAP basis, effective tax rate changed from 15.9% to 15.5%, due to the aforementioned tax reserve releases and changes to our Puerto Rico tax decree.
• The company reported net earnings attributable to Bristol Myers Squibb of $2.3 billion, or GAAP EPS of $1.07, in the first quarter, compared to $1.3 billion, or $0.59 per share, for the same period a year ago. In addition to the items discussed above, the higher GAAP EPS in the first quarter of 2023 was due to lower equity investments losses, higher litigation and other settlements income in the first quarter of 2023 and a debt redemption charge in the same period a year ago.
• The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $4.3 billion, or non-GAAP EPS of $2.05, in the first quarter, compared to non-GAAP net earnings of $4.2 billion, or non-GAAP EPS of $1.96 per share, for the same period a year ago.
• In addition to the items discussed above, the earnings per share results in the first quarter of 2023 include the impact of lower weighted-average common shares outstanding.

FIRST QUARTER PRODUCT REVENUE HIGHLIGHTS

FIRST QUARTER PRODUCT REVENUE HIGHLIGHTS

In-Line Products

Revenues for in-line products in the first quarter were $8.6 billion compared to $8.3 billion in the prior year period, representing an increase of 4% or 6% when adjusted for foreign exchange. In-line products revenue was largely driven by:

• Opdivo worldwide revenues increased 15% compared to the prior year period. U.S. revenues were $1.3 billion compared to $1.1 billion in the prior year period, representing an increase of 17% due to higher demand across multiple indications, partially offset by declining second-line eligibility across tumor indications. The higher demand was related to the following indications: the Opdivo+Yervoy combinations for non-small cell lung cancer, various gastric, esophageal and bladder cancers. International revenues were $912 million compared to $824 million in the prior year period, representing an increase of 11% driven by higher demand as a result of additional indication launches and core indications, partially offset by foreign exchange impacts of 7%. Excluding foreign exchange impacts, revenues increased 18%.
• Eliquis worldwide revenues grew 7% compared to the prior year period. U.S. revenues were $2.6 billion compared to $2.1 billion in the prior year period, representing an increase of 19% primarily driven by higher demand. International revenues were $869 million compared to $1.1 billion in the prior year period, representing a decrease of 18%, primarily driven by generic erosion in Canada and the U.K. and foreign exchange impacts of 5%. Excluding foreign exchange impacts, revenues declined 13%.

New Product Portfolio

• New product portfolio worldwide revenues grew to $723 million compared to $350 million in the prior year period, driven by the launch of Opdualag in March 2022 and higher demand for Abecma and Reblozyl.

Recent LOE Products

• Revlimid worldwide revenues declined by 37% compared to the prior year period primarily driven by generic erosion.

PRODUCT AND PIPELINE UPDATE

Cardiovascular

Oncology

Hematology

Immunology

Business Development

• In April, the company announced an agreement for a vector facility to further strengthen its cell therapy supply chain and expand manufacturing capacity. This will allow Bristol Myers Squibb to dual-source vector supply and transition to newer, higher efficiency manufacturing processes. The transaction is expected to close in the second half of 2023, subject to the fulfillment of applicable closing conditions.

Environmental, Social & Governance (ESG)

• On March 15, 2023, the company announced meaningful progress toward its global inclusion & diversity goals and health equity commitments, detailing that the company is on track to achieve many of our goals and exceeding some goals ahead of schedule. In addition, the company introduced new workforce representation goals for Executive Directors and above to strengthen our internal pipeline of talent and next generation of leaders at Bristol Myers Squibb.

As a leading biopharmaceutical company, we understand our responsibility extends well beyond the discovery, development, and delivery of innovative medicines. Our evolving Environmental, Social, and Governance (ESG) strategy builds on a legacy of comprehensive and global sustainability efforts. To learn more about our priorities and goals, please visit our latest ESG report.

Financial Guidance

Bristol Myers Squibb is adjusting its 2023 GAAP line-item guidance as follows:

Adjusting GAAP EPS guidance primarily due to changes in other settlement income and in the fair market value of equity investments while affirming non-GAAP EPS guidance.

Key 2023 GAAP and non-GAAP line-item guidance assumptions are:

The 2023 financial guidance excludes the impact of any potential future strategic acquisitions and divestitures, and any specified items that have not yet been identified and quantified and impact of future Acquired IPRD charges. To the extent we have quantified the impact of significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights, we may update this information from time to time on our website www.bms.com, in the "Investors" section. GAAP and non-GAAP guidance assume current exchange rates. The 2023 non-GAAP EPS guidance is further explained under “Use of Non-GAAP Financial Information.” The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.

Conference Call Information

Bristol Myers Squibb will host a conference call today, Thursday, April 27, 2023, at 8:00 a.m. ET during which company executives will review the quarterly financial results and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at http://investor.bms.com.

Investors and the public can also access the live conference call by dialing in the U.S. toll free 888-300-3045 or international +1 646-568-1027, confirmation code: 3734085. Materials related to the call will be available at http://investor.bms.com prior to the start of the conference call.

A replay of the webcast will be available at http://investor.bms.com approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at 11:30 a.m. ET on April 27 through 11:30 a.m. ET on May 11, 2023, by dialing in the U.S. toll free 800-770-2030 or international +1 647-362-9199, confirmation code: 3734085.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

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Use of Non-GAAP Financial Information

In discussing financial results and guidance, the company 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 press release 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. In addition, non-GAAP gross margin, which is gross profit excluding certain specified items, as a percentage of revenues, non-GAAP operating margin, which is gross profit less marketing, selling and administrative expenses and research and development expense excluding certain specified items as a percentage of revenues, non-GAAP operating expenses, which is marketing, selling and administrative and research and development expenses excluding certain specified items, non-GAAP marketing, selling and administrative expenses, which is marketing, selling and administrative expense excluding certain specified items, and non-GAAP research and development expenses, which is research and development expenses excluding certain specified items, are relevant and useful for investors because they allow investors to view performance in a manner similar to the method used by our management and make it easier for investors, analysts and peers to compare our operating performance to other companies in our industry and to compare our year-over-year results.

This earnings release and the accompanying tables also provide certain revenues and expenses as well as non-GAAP measures excluding the impact of foreign exchange ("Ex-Fx"). We calculate foreign exchange impacts by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our current-period results. Ex-Fx financial measures are not accounted for according to GAAP because they remove the effects of currency movements from GAAP results.

Non-GAAP financial measures such as 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 the company believes they neither relate to the ordinary course of the company’s business nor reflect the company’s underlying business performance. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including amortization of acquired intangible assets, including product rights that generate a significant portion of our ongoing revenue and will recur until the intangible assets are fully amortized, unwind of inventory purchase price adjustments, acquisition and integration expenses, restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, costs of acquiring a priority review voucher, divestiture gains or losses, stock compensation resulting from acquisition-related equity awards, pension, legal and other contractual settlement charges, equity investment and contingent value rights fair value adjustments (including fair value adjustments attributed to limited partnership equity method investments), income resulting from the change in control of the Nimbus Therapeutics TYK2 Program and amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates.

Because the non-GAAP financial measures are not calculated in accordance with GAAP, they should not be considered superior to and are not intended to be considered in isolation or as a substitute for the related financial measures presented in the press release that are prepared in accordance with GAAP 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.

Reconciliations of the non-GAAP financial measures to the most comparable GAAP measures are provided in the accompanying financial tables and will also be available on the company’s website at www.bms.com. Within the accompanying financial tables presented, certain columns and rows may not add due to the use of rounded numbers. Percentages and earnings per share amounts presented are calculated from the underlying amounts.

Also note that a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses and non-GAAP tax rate is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not able to reliably predict the impact of the 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. In addition, the company 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.

Website Information

We routinely post important information for investors on our website, BMS.com, in the “Investors” section. We may use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investors section of our website, in addition to following our press releases, SEC filings, public conference calls, presentations and webcasts. We may also use social media channels to communicate with our investors and the public about our company, our products and other matters, and those communications could be deemed to be material information. The information contained on, or that may be accessed through, our website or social media channels are not incorporated by reference into, and are not a part of, this document.

Cautionary Statement Regarding Forward-Looking Statements

This earnings release and the related attachments (as well as the oral statements made with respect to information contained in this release and the attachments) contain certain “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 Company’s 2023 financial guidance, plans and strategy, including its business development and capital allocation strategy, anticipated developments in the company’s pipeline and expectations with respect to the company’s future market position. 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. No forward-looking statement can be guaranteed and there is no assurance that the company will achieve its financial guidance and long-term targets, that the company’s future clinical studies will support the data described in this release, that the company’s product candidates will receive necessary clinical and manufacturing regulatory approvals, that the company’s pipeline products will prove to be commercially successful, that clinical and manufacturing regulatory approvals will be sought or obtained within currently expected timeframes, or that contractual milestones will be achieved.

Forward-looking statements are based on current expectations and projections about the company’s future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond the company’s control and could cause the company’s future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. Such risks, uncertainties and other matters include, but are not limited to: increasing pricing pressures from market access, pharmaceutical pricing controls and discounting; market actions taken by private and government payers to manage drug utilization and contain costs; the company’s ability to retain patent exclusivity of certain products; regulatory changes that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse; changes under the 340B Drug Pricing Program; the company’s ability to obtain and maintain regulatory approval for its product candidates; the company’s ability to obtain and protect market exclusivity rights and enforce patents and other intellectual property rights; the possibility of difficulties and delays in product introduction and commercialization; increasing industry competition; potential difficulties, delays and disruptions in manufacturing, distribution or sale of products; the company’s ability to identify potential strategic acquisitions, licensing opportunities or other beneficial transactions; failure to complete, or delays in completing, collaborations, acquisitions, divestitures, alliances and other portfolio actions and the failure to achieve anticipated benefits from such transactions and actions; the risk of an adverse patent litigation decision or settlement and exposure to other litigation and/or regulatory actions or investigations; the impact of any healthcare reform and legislation or regulatory action in the United States and international markets; increasing market penetration of lower-priced generic products; the failure of the company’s suppliers, vendors, outsourcing partners, alliance partners and other third parties to meet their contractual, regulatory and other obligations; the impact of counterfeit or unregistered versions of the company’s products and from stolen products; product label changes or other measures that could reduce the product's market acceptance for the company's products and result in declining sales; safety or efficacy concerns regarding the company’s products or any product in the same class as the company’s products; the risk of cyber-attacks on the company’s information systems or products and unauthorized disclosure of trade secrets or other confidential data; the company’s ability to execute its financial, strategic and operational plans; the company’s dependency on several key products; any decline in the company’s future royalty streams; the company’s ability to attract and retain key personnel; the impact of the company’s significant indebtedness; political and financial instability of international economies and sovereign risk including as a result of the Russian Federation-Ukraine conflict; interest rate and currency exchange rate fluctuations, credit and foreign exchange risk management; risks relating to the use of social media platforms; the impact of our exclusive forum provision in our by-laws for certain lawsuits on our stockholders’ ability to obtain a judicial forum that it finds favorable for such lawsuits; issuance of new or revised accounting standards; and risks relating to public health outbreaks, epidemics and pandemics, including the impact of the COVID-19 pandemic on the company’s operations.

Forward-looking statements in this earnings release should be evaluated together with the many risks and uncertainties that affect the company’s business and market, particularly those identified in the cautionary statement and risk factors discussion in the company’s Annual Report on Form 10- K for the year ended December 31, 2022, as updated by the company’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, the company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

The GAAP financial results for the full year of 2023 will include specified items, including but not limited to purchase price accounting adjustments, acquisition and integration expenses, charges associated with restructuring, cost of acquiring a priority review voucher, equity investment losses (including fair value adjustments attributed to limited partnership equity method investments), impairment of intangible assets, and litigation and other settlements. The 2023 financial guidance excludes the impact of any potential future strategic acquisitions and divestitures and any specified items that have not yet been identified and quantified. For a fuller discussion of items that could impact full year GAAP results, as well as the use of non-GAAP financial information, see Bristol Myers Squibb Reports First Quarter Financial Results for 2023 on April 27, 2023, including “Financial Guidance” and “Use of non-GAAP Financial Information” therein.

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