- Spotlights Key Drivers of Growth for Upcoming Decade, Including Progress on New Launches and Forthcoming Clinical and Regulatory Milestones across Product Pipeline
- Announces $5 Billion Accelerated Share Repurchase Agreement to Be Executed During the First Quarter
- Provides 2022 Total Revenue and Non-GAAP EPS Guidance
- Reaffirms Long-Term Financial Targets
Bristol Myers Squibb (NYSE:BMY) will highlight progress against the Company’s growth strategy and outlook for 2022 during a presentation scheduled today at 7:30 a.m. ET at the 40th Annual J.P. Morgan Healthcare Conference.
“We are successfully transforming the company by further diversifying our product portfolio, launching breakthrough new medicines that benefit our patients and advancing a robust product pipeline that will help us deliver sustained growth,” said Giovanni Caforio, M.D., board chair and chief executive officer, Bristol Myers Squibb. “We are entering 2022 excited about the growth opportunities in our in-line brands and new product portfolio. With our strong financial position, we continue to invest in internal and external innovation to further enhance and diversify our pipeline, while delivering new medicines to patients with serious disease and creating long-term value for our shareholders.”
Highlights of the presentation
Bristol Myers Squibb’s presentation will focus on four key drivers positioning the Company for sustained growth and value creation, helping to offset losses of exclusivity in the coming years. The drivers build upon a strong foundation of existing in-line products, including Opdivo® (nivolumab), Yervoy® (ipilimumab) and Eliquis® (apixaban), which are expected to contribute approximately $8-$10 billion in revenue growth during the period of 2020-2025. The drivers include:
New product portfolio with significant growth potential. With six recent launches (Abecma® (idecabtagene vicleucel), Breyanzi® (lisocabtagene maraleucel), Inrebic® (fedratinib), Onureg® (azacytidine), Reblozyl® (luspatercept-aamt) and Zeposia® (ozanimod)) and three launches anticipated in 2022 (relatimab and nivolumab fixed dose combination, mavacamten, deucravacitinib), Bristol Myers Squibb’s renewed and diverse product portfolio has the potential to deliver:
- $10-$13 billion of risk-adjusted revenue in 2025;
- More than $25 billion non-risk-adjusted revenue in 2029; and
- At least $4 billion of non-risk adjusted revenue in 2029 for each of the following recent or anticipated new products: Reblozyl, relatimab and nivolumab fixed dose combination, mavacamten and deucravacitinib.
- Promising mid- to late-stage assets with large commercial opportunities. Bristol Myers Squibb has seven key assets in its mid-to-late-stage pipeline focused on disease areas where there are meaningful opportunities to improve outcomes for patients. These assets include milvexian, which has demonstrated a differentiated profile as a next generation anti-thrombotic therapy, and two novel CELMoDs, iberdomide and CC-92480, with potential to be new foundational treatments in multiple myeloma.
- Powerful innovation engine driving a broad early-stage pipeline. With more than 50 assets in its early-stage pipeline and the opportunity for more than 20 proof of concept decisions over the next three years, Bristol Myers Squibb is advancing one of the most exciting pipelines in the industry, amplified by the Company’s strong external partnerships.
- Strong cash flow generation provides significant financial strength and flexibility. Bristol Myers Squibb plans to leverage its $45-$50 billion in expected free cash flow between 2022 and 2024 to execute a consistent, balanced capital allocation strategy, prioritizing business development and returning cash to shareholders through the Company’s dividend and share repurchase program. The Company remains committed to maintaining a strong investment grade rating and reducing debt.
Announcement of Accelerated Share Repurchase Program
Today, the Company also announced that it plans to execute an accelerated share repurchase (ASR) agreement during the first quarter of 2022 to repurchase up to $5 billion of Bristol Myers Squibb common stock. The ASR is part of the Company’s previously disclosed multi-year $15 billion share repurchase authorization.
The total number of shares ultimately repurchased will be determined upon final settlement and will be based on a discount to the volume-weighted average price of Bristol Myers Squibb’s common stock during the ASR period.
Introduction of 2022 Financial Guidance
Bristol Myers Squibb is introducing the following guidance metrics for 2022:
- Total company revenues are expected to be approximately $47 billion, representing an increase in the low-single digits.
- Sales from key loss of exclusivity (LOE) brands, which represent Revlimid and Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), are expected to be approximately $10.5 billion. Revlimid sales are expected to be $9.5-$10 billion.
- Our Continuing Business is expected to grow in the low-double digits and contribute approximately $36.5 billion in 2022 with growth from the new product portfolio and in-line products.
- The Company’s non-GAAP EPS guidance is expected to be in the range of $7.65 - $7.95. Non-GAAP EPS guidance assumes current exchange rates.
The Company intends to provide additional 2022 financial guidance during its 2021 fourth quarter earnings conference call on February 4, 2022.
The 2022 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. The 2022 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.
Reaffirms Long-Term Financial Targets
Bristol Myers Squibb is also reaffirming its 2020-2025 long-term revenue and operating margin targets communicated in January 2021. The Company is extending its previously communicated guidance for free cash flow for an additional year as detailed below:
- Expects low to mid-single digit revenue CAGR and low double-digit revenue CAGR excluding Revlimid and Pomalyst® (pomalidomide) at constant exchange rates
- Expects to maintain low to mid-40s percent non-GAAP operating margin
- Expects significant cash flow generation of $45-$50 billion dollars from 2022-2024 compared to prior guidance of $45-$50 billion dollars from 2021-2023
This financial guidance excludes the impact of any potential future strategic acquisitions and divestitures as well as any specified items as discussed under “Use of Non-GAAP Financial Information.” There is no reliable or reasonably estimable comparable GAAP measures for this non-GAAP financial guidance. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.
Company and Webcast Information
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.
Investors and the general public are invited to listen to a live webcast of the J.P. Morgan presentation at http://investor.bms.com. Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the presentation will be available later that day.
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), including non-GAAP EPS, operating margin and free cash flow. These non-GAAP financial measures may provide investors with additional useful information. For example, non-GAAP earnings and EPS information are indications of the company’s baseline performance before items that are considered by us to not be reflective of the company’s ongoing results. This information is among the primary indicators that we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods. In addition, non-GAAP operating margin, which is operating income excluding certain specified items as a percentage of revenues, is relevant and useful for investors because it allows 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.
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 GAAP financial measures 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.
Also note that a reconciliation of the forward-looking non-GAAP EPS, free cash flow, and operating margin measures is not provided due to no reasonably accessible or reliable comparable GAAP measures and the inherent difficulty in forecasting and quantifying such measures that are necessary for such reconciliation. Namely, we are not able to reliably predict the impact of specified items 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, 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.
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 press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the company’s current and projected financial position, results of operations, market position, product development, share repurchase program, and business strategy. 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 likely to relate to, among other things, the company’s ability to execute successfully its strategic plans, including its business development strategy generally and in relation to its ability to realize the projected benefits of the Celgene acquisition and the MyoKardia acquisition, the full extent of the impact of the COVID-19 pandemic on the company’s operations and the development and commercialization of its products, potential laws and regulations to lower drug costs, market actions taken by private and government payers to manage drug utilization and contain costs, the expiration of patents or data protection on certain products, including assumptions about the company’s ability to retain patent exclusivity of certain products and the impact and the result of governmental investigations. No forward-looking statement can be guaranteed, including that product candidates will receive necessary clinical and manufacturing regulatory approvals, pipeline products will prove to be commercially successful, clinical and manufacturing regulatory approvals will be sought or obtained within currently expected timeframes or contractual milestones will be achieved.
Forward-looking statements are based on current expectations and projections about our 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 our control and could cause our 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; changes to tax and importation laws and other restrictions in the United States, the European Union and other regions around the world that result in lower prices, lower reimbursement rates and smaller populations for whom payers will reimburse; challenges inherent in new product development, including obtaining and maintaining regulatory approval; 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; the risk of certain novel approaches to disease treatment (such as CAR T therapy); industry competition from other manufacturers; potential difficulties, delays and disruptions in manufacturing, distribution or sale of products, including without limitation, interruptions caused by damage to the company’s and the company’s suppliers’ manufacturing sites; the impact of integrating the company’s and Celgene’s business and operations, including with respect to human capital management, portfolio rationalization, finance and accounting systems, sales operations and product distribution, pricing systems and methodologies, data security systems, compliance programs and internal controls processes, on the company’s ability to realize the anticipated benefits from the Celgene acquisition; the risk of an adverse patent litigation decision or settlement and exposure to other litigation and/or regulatory actions; the impact of any healthcare reform and legislation or regulatory action in the United States and international markets; changes in tax law and regulations; the failure of the company’s suppliers, vendors, outsourcing partners, alliance partners and other third parties to meet their contractual, regulatory and other obligations; regulatory decisions impacting labeling, manufacturing processes and/or other matters; the impact on the company’s competitive position from counterfeit or unregistered versions of its products or stolen products; the adverse impact of cyber-attacks on the company’s information systems or products, including unauthorized disclosure of trade secrets or other confidential data stored in the company’s information systems and networks; the company’s ability to execute its financial, strategic and operational plans; the company’s ability to identify potential strategic acquisitions, licensing opportunities or other beneficial transactions; the company’s dependency on several key products; any decline in the company’s future royalty streams; the company’s ability to effectively manage acquisitions, divestitures, alliances and other portfolio actions and to successfully realize the expected benefits of such actions; the company’s ability to attract and retain key personnel; the impact of the company’s significant additional indebtedness that it incurred in connection with the Celgene acquisition and the MyoKardia acquisition and its issuance of additional shares in connection with the Celgene acquisition on its ability to operate the combined company; political and financial instability of international economies and sovereign risk; interest rate and currency exchange rate fluctuations, credit and foreign exchange risk management; 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. In addition, the financial guidance provided in this release relies on assumptions about the duration and severity of the COVID-19 pandemic, timing of the return to a more stable business environment, patient and physician behaviors, buying patterns and clinical trial activities (together, the “Recovery Process”), among other things. If the actual Recovery Process differs materially from our assumptions, the impact of COVID-19 on our business could be worse than expected and our results may be negatively impacted.
Forward-looking statements in this press release 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, 2020, as updated by our 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, Bristol Myers Squibb 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.
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