Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2021
Bristol Myers Squibb (NYSE:BMY) reported Q4 revenues of $12.0 billion, an 8% increase driven by robust sales of Eliquis and immuno-oncology products. Full-year revenues reached $46.4 billion, up 9%. Q4 earnings per share (EPS) stood at $1.07 (GAAP) and $1.83 (non-GAAP), with annual EPS at $3.12 and $7.51 respectively. The company announced a $15 billion share repurchase authorization and provided 2022 guidance, predicting $47 billion in revenues. The outlook includes expected growth from new products and a reduction in operating expenses.
- Q4 revenues increased by 8% to $12.0 billion.
- Full-year revenues rose by 9% to $46.4 billion.
- Announced $15 billion share repurchase authorization.
- Projected GAAP EPS guidance for 2022 is $3.37 - $3.67.
- Sales from key loss of exclusivity brands expected to be approximately $10.5 billion in 2022.
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Reports Fourth Quarter Revenues of
; Full-Year Revenues of$12.0 Billion $46.4 Billion -
Posts Fourth Quarter Earnings Per Share of
and Non-GAAP EPS of$1.07 ; Posts Full-Year Earnings Per Share of$1.83 and Non-GAAP EPS of$3.12 $7.51 - Delivers Strong Revenues for Eliquis, Immuno-Oncology and New Product Portfolios
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Advances Pipeline with Achievement of Significant Clinical and Regulatory Milestones;
Builds Strong Foundation for Portfolio Renewal -
Announces
Share Repurchase Authorization;$15 Billion Accelerated Share Repurchase Agreement to be Executed During the First Quarter 2022$5 Billion - Provides GAAP and More Detailed Non-GAAP Financial Guidance for 2022
- Reaffirms Long-term Financial Targets
“I am proud of how our company performed in 2021, helping more patients across our therapeutic areas, while achieving
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Fourth Quarter |
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$ amounts in millions, except per share amounts |
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2021 |
2020 |
Change |
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Total Revenues |
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Earnings (Loss) Per Share - GAAP |
1.07 |
(4.45) |
* |
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Earnings Per Share - Non-GAAP |
1.83 |
1.46 |
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Full-Year |
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2021 |
2020 |
Change |
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Total Revenues |
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Earnings (Loss) Per Share - GAAP |
3.12 |
(3.99) |
* |
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Earnings Per Share - Non-GAAP |
7.51 |
6.44 |
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*In excess of +
FOURTH QUARTER FINANCIAL RESULTS
All comparisons are made versus the same period in 2020 unless otherwise stated.
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Bristol Myers Squibb posted fourth quarter revenues of , an increase of$12.0 billion 8% , driven by Eliquis, our Immuno-Oncology and new product portfolios. -
U.S. revenues increased11% to in the quarter. International revenues increased$7.5 billion 4% to in the quarter. When adjusted for foreign exchange impact, international revenues increased$4.5 billion 7% . -
Gross margin increased from
73.7% to80.3% in the quarter primarily due to an impairment charge related to marketed product rights in the same period a year ago and lower unwinding of inventory purchase price accounting adjustments.
On a non-GAAP basis, gross margin increased from79.8% to80.3% in the quarter primarily driven by foreign exchange and lower royalties. -
Marketing, selling and administrative expenses decreased
13% to in the quarter primarily due to cash settlement of$2.4 billion MyoKardia unvested stock awards in the prior year, and certain incremental and accelerated investments to support our business in 2020, partially offset by investments to support new product launches.
On a non-GAAP basis, marketing, selling and administrative expenses decreased5% in the quarter primarily due to certain incremental and accelerated investments to support our business in 2020, partially offset by investments to support new product launches. -
Research and development expenses decreased
30% to in the quarter. The same period a year ago included license and acquisition charges related to Dragonfly, an in-process research and development (IPR&D) impairment charge and cash settlement of$2.6 billion MyoKardia unvested stock awards.
On a non-GAAP basis, research and development expenses increased3% to in the quarter primarily due to higher costs related to investments in the overall portfolio.$2.6 billion -
Amortization of acquired intangible assets decreased
4% to in the quarter primarily due to an extended marketed product rights exclusivity period.$2.4 billion -
The effective tax benefit rate was
27.7% in the quarter. Income tax benefit was approximately despite pre-tax earnings of$510 million in the quarter primarily due to the impact of internal transfers of certain intangible assets of$1.9 billion .$1.0 billion
On a non-GAAP basis, the effective tax rate decreased0.5% to15.0% in the quarter primarily due to earnings mix. -
The company reported net earnings attributable to
Bristol Myers Squibb of , or$2.4 billion per share, in the fourth quarter, compared to net loss of$1.07 , or$10.0 billion per share, for the same period a year ago. In addition to the items discussed above, the results in the same period a year ago included an IPR&D charge related to the$(4.45) MyoKardia asset acquisition of and the impact of fair value adjustments on equity investments and contingent value rights in both periods.$11.4 billion -
The company reported non-GAAP net earnings attributable to
Bristol Myers Squibb of , or$4.1 billion per share, in the fourth quarter, compared to non-GAAP net earnings of$1.83 , or$3.3 billion per share, for the same period a year ago.$1.46
A discussion of the non-GAAP financial measures is included under the “Use of Non-GAAP Financial Information” section.
FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS
$ amounts in millions |
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Product |
Quarter Ended
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Quarter Ended
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% Change from Quarter
Ended 2020 |
Revlimid*** |
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(2)% |
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Abraxane*** |
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Reblozyl** |
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(11)% |
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Abecma** |
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N/A |
N/A |
Zeposia** |
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* |
Breyanzi** |
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N/A |
N/A |
Inrebic** |
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Onureg** |
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*In excess of +
** Included as part of the new product portfolio
***Included as part of the key loss of exclusivity (LOE) brands
TWELVE-MONTH PRODUCT REVENUE HIGHLIGHTS
$ amounts in millions |
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Product |
Twelve Months Ended
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Twelve Months Ended
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% Change from Twelve Months Ended
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Revlimid*** |
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(1)% |
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Abraxane*** |
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(5)% |
Reblozyl** |
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* |
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(12)% |
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Abecma** |
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N/A |
N/A |
Zeposia** |
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* |
Breyanzi** |
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N/A |
N/A |
Inrebic** |
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Onureg** |
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* |
*In excess of +
**Included as part of the new product portfolio
***Included as part of the key loss of exclusivity (LOE) brands
FOURTH QUARTER PRODUCT AND PIPELINE UPDATE
Cardiovascular
mavacamten
Regulatory
-
In November, the company announced that the
U.S. Food and Drug Administration (FDA) has extended the review of the New Drug Application (NDA) for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy toApril 28, 2022 . The extension will allow sufficient time to review information pertaining to updates of the proposed Risk Evaluation Mitigation Strategy (REMS). A REMS program was included in the initial application for mavacamten. No additional data or studies have been requested. (link)
Cardiovascular Portfolio
Medical Meetings
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In November, the company presented new data from across its cardiovascular portfolio (link) at the American Heart Association’s (AHA) annual Scientific Sessions, including results from: the:
- Phase 2 AXIOMATIC-TKR trial that showed milvexian reduced the risk of postoperative venous thromboembolism in a dose dependent manner without increasing the risk of bleeding compared with enoxaparin in patients undergoing total knee replacement surgery. The study was conducted by The Bristol Myers Squibb-Janssen Collaboration. (link)
Oncology
Opdivo
Clinical
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In November, the company announced that the Phase 3 CheckMate -816 trial met the co-primary endpoint of improved event-free survival (EFS) in patients with resectable Stage IB to
IIIA non-small cell lung cancer. In a prespecified interim analysis, Opdivo® (nivolumab) plus chemotherapy showed a statistically significant and clinically meaningful improvement in EFS compared to chemotherapy alone when given before surgery. This combination previously showed a significant improvement of pathologic complete response, the trial’s other primary endpoint. (link)
Hematology
Breyanzi
Regulatory
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In January, the company announced that the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has recommended approval of Breyanzi® (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B after at least two prior therapies. The recommendation is based on results from TRANSCEND NHL 001 and data from the TRANSCEND WORLD study. (link)
Reblozyl
Regulatory
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In December, the company announced two regulatory applications for Reblozyl® (luspatercept-aamt) have been accepted. The FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Reblozyl for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia. The FDA has set a PDUFA goal date of
March 27, 2022 . The EMA also validated the Type II variation for Reblozyl for NTD beta thalassemia. The applications are based on results from the Phase 2 BEYOND trial. (link)
Hematology Portfolio
Medical Meetings
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In December, the company announced new data and analyses from across its hematology portfolio (link) that were presented at the
American Society of Hematology (ASH) Annual Meeting, including results from the:- Phase 3 TRANSFORM trial, which showed Breyanzi significantly improved EFS compared to chemotherapy plus autologous stem cell transplant as second line treatment in adults with relapsed or refractory large B-cell lymphoma. (link)
Immunology
Orencia
Regulatory
- In December, the company announced that Orencia® (abatacept) was approved by the FDA for the prophylaxis, or prevention, of acute graft versus host disease, in combination with a calcineurin inhibitor and methotrexate, in patients 2 years of age and older undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donor. The approval is based on results from the Phase 2 GVHD-1 trial, also known as ABA2, and a non-interventional (observational) study known as GVHD-2. (link)
Zeposia
Regulatory
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In November, the company announced that the
European Commission (EC) approved Zeposia® (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. The EC’s decision is based on results from the Phase 3 True North trial. (link)
deucravacitinib
Regulatory
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In November, the company announced three regulatory applications for deucravacitinib have been accepted for review. The FDA has accepted the NDA and the EMA has validated the Marketing Authorization Application for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis. The FDA has assigned a PDUFA goal date of
September 10, 2022 .Japan's Ministry of Health, Labour and Welfare also accepted the NDA for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis. The applications are based on the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials. (link)
Environmental, Social & Governance (ESG)
In December, the company issued its 2021 Global Access Report that detailed Bristol Myers Squibb’s efforts and progress towards advancing access to healthcare and health equity globally through its own efforts and in partnership with other stakeholders. (link)
Business Development
-
In January, the company and
Century Therapeutics (NASDAQ: IPSC) announced a research collaboration and license agreement to develop and commercialize up to four induced pluripotent stem cell derived, engineered natural killer cell and / or T cell programs for hematologic malignancies and solid tumors. (link) -
In December, the company and
Immatics N.V. (NASDAQ: IMTX, “Immatics”), announced that they have entered into a license, development and commercialization agreement for Immatics’ TCR Bispecific candidate, IMA401. (link)
Capital Allocation
The company continues to maintain a consistent, balanced approach to capital allocation focused on prioritizing investment for growth through business development along with reducing debt, commitment to dividend growth and share repurchase.
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In December, the company announced that its Board of Directors approved an increase in the quarterly dividend and authorized an additional
, multi-year share repurchase program. (link) As part of that program, in January, the company announced that it plans to execute an accelerated share repurchase agreement during the first quarter of 2022 to repurchase up to$15 billion of$5 billion Bristol Myers Squibb common stock. (link)
Financial Guidance
-
Worldwide revenues are expected to be approximately
, representing an increase in the low-single digits.$47 billion -
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
. Revlimid sales are expected to be$10.5 billion .$9.5 -$10 billion -
Our Continuing Business, which represents in-line products and new product portfolio, is expected to grow in the low-double digits and contribute approximately
in 2022.$36.5 billion
-
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
-
Gross margin is expected to be approximately
78% for GAAP and for non-GAAP. -
Operating expenses, consisting of marketing, selling and administrative expenses and research and development expenses, are expected to decrease by approximately
10% for GAAP and be in-line with 2021 levels for non-GAAP. -
An effective tax rate of approximately
24% for GAAP and approximately16.5% for non-GAAP.
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
- Expects low- to mid-single digit revenue CAGR and low double-digit revenue CAGR for our Continuing Business at constant exchange rates
- Expects to maintain low- to mid-40s percent non-GAAP operating margin
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Expects significant free cash flow generation of
from 2022-2024$45 -$50 billion dollars
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 Conference Call Information
There will be a conference call on
Investors and the public can also access the live webcast by dialing in the
A replay of the webcast will be available on http://investor.bms.com approximately three hours after the conference call concludes. A replay of the conference call will be available beginning at
Corporatefinancial-news
Use of Non-GAAP Financial Information
In discussing financial results and guidance, the company refers to financial measures that are not in accordance with
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. 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.
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, R&D charges or other income resulting from up-front or contingent milestone payments in connection with the acquisition or licensing of third-party intellectual property rights, divestiture gains or losses, stock compensation resulting from accelerated vesting of Celgene awards, certain retention-related employee compensation charges related to the Celgene transaction, 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 beginning in 2021) and amortization of fair value adjustments of debt acquired from Celgene in our 2019 exchange offer, among other items. Certain other significant tax items are also excluded such as the impact resulting from internal transfers due to streamlining our legal entity structure subsequent to the Celgene acquisition and the global intangible low taxed income tax change upon finalization of the Otezla* divestiture in 2020. 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 also available on the company’s website at www.bms.com. Within the attached 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 the forward-looking revenue (ex-FX), free cash flow and non-GAAP operating margin measures 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 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.
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,
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, statements relating to goals, plans and projections regarding 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 and capital allocation strategy, planned product launches and updates, expectations relating to its pipeline and in relation to its ability to realize the projected benefits of the Celgene acquisition and the
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; changes to tax and importation laws and other restrictions in
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
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