Bristol Myers Squibb Reports Fourth Quarter and Full-Year Financial Results for 2022
February 2, 2023-
Reports Fourth Quarter Revenues of $11.4 Billion; Full-Year Revenues of $46.2 Billion
- Fourth Quarter Revenues from In-Line Products and New Product Portfolio were $9.0 Billion, an Increase of 7%, or 12% When Adjusted for Foreign Exchange
- Full-Year Revenues from In-Line Products and New Product Portfolio were $35.4 Billion, an Increase of 9%, or 13% When Adjusted for Foreign Exchange
- Posts Fourth Quarter GAAP EPS of $0.95 and Non-GAAP EPS of $1.82; Includes Net Impact of ($0.01) Per Share for GAAP and Non-GAAP EPS Due to Acquired IPRD Charges and Licensing Income
- Reports Full-Year GAAP EPS of $2.95 and Non-GAAP EPS of $7.70; Includes Net Impact of ($0.24) Per Share for GAAP and Non-GAAP EPS Due to Acquired IPRD Charges and Licensing Income
- Provides GAAP and Non-GAAP Financial Guidance for 2023 Reflecting Continued Revenue and Earnings Growth
NEW YORK–(BUSINESS WIRE)–$BMY #BMS—Bristol Myers Squibb (NYSE:BMY) today reports results for the fourth quarter and full year of 2022, which reflect robust growth of the in-line and new product portfolios, driven by strong commercial execution and continued progress of the company’s pipeline.
“2022 was a successful year for our company, one of significant clinical and regulatory achievements that broadened our product portfolio and advanced our pipeline,” said Giovanni Caforio, M.D., board chair and chief executive officer, Bristol Myers Squibb. “We are especially proud to have launched three first-in-class medicines that address serious unmet medical needs for patients. Our financial strength, talented workforce and proven ability to execute will enable us to continue to progress our pipeline and invest in future sources of innovation. With a younger and more diversified portfolio, promising mid-to-late stage registrational assets and a deep early-stage pipeline, I am confident that the company is well positioned for multiple waves of innovation that will support long-term growth.”
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Fourth Quarter |
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$ amounts in millions, except per share amounts |
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|
|
2022 |
2021 |
Change |
Change |
|
|
|
|
|
Excl. F/X** |
|
Total Revenues |
$11,406 |
$11,985 |
(5)% |
(1)% |
|
Earnings Per Share – GAAP* |
0.95 |
1.07 |
(11)% |
N/A |
|
Earnings Per Share – Non-GAAP* |
1.82 |
1.84 |
(1)% |
N/A |
|
|
|
|
|
|
* GAAP and non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income of ($0.01) per share in the fourth quarter of 2022 and 2021.
** See “Use of Non-GAAP Financial Information.”
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Full Year |
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$ amounts in millions, except per share amounts |
||||
|
|
2022 |
2021 |
Change |
Change |
|
|
|
|
|
Excl. F/X** |
|
Total Revenues |
$46,159 |
$46,385 |
— |
3 % |
|
Earnings Per Share – GAAP* |
2.95 |
3.12 |
(5)% |
N/A |
|
Earnings Per Share – Non-GAAP* |
7.70 |
7.16 |
8 % |
N/A |
|
|
|
|
|
|
* GAAP and non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income of ($0.24) per share in 2022 compared to ($0.40) per share in 2021.
** See “Use of Non-GAAP Financial Information.”
FOURTH QUARTER FINANCIAL RESULTS
All comparisons are made versus the same period in 2021 unless otherwise stated.
- Bristol Myers Squibb posted revenues of $11.4 billion, a decrease of 5%, driven by recent LOE products (primarily Revlimid) and foreign exchange impacts, partially offset by in-line products (primarily Opdivo) and our new product portfolio (primarily Opdualag and Abecma). When adjusted for foreign exchange, revenues decreased 1%. Our in-line products and new product portfolio increased 7% to $9.0 billion, or 12% when adjusted for foreign exchange.
- U.S. revenues increased 5% to $7.9 billion. International revenues decreased 22% to $3.5 billion. When adjusted for foreign exchange, international revenues decreased 13%, primarily due to lower demand for Revlimid as a result of generic erosion, partially offset by in-line products (primarily Opdivo) and our new product portfolio.
- Gross margin decreased from 80.3% to 77.3% and decreased from 80.3% to 77.9% on a non-GAAP basis primarily due to product mix and higher manufacturing costs.
- On a GAAP and non-GAAP basis, marketing, selling and administrative expenses decreased 4% to $2.3 billion primarily due to foreign exchange.
- On a GAAP and non-GAAP basis, research and development expenses remained constant at $2.5 billion.
- Acquired IPRD expenses decreased from $89 million in 2021 to $52 million in 2022.
- Amortization of acquired intangible assets decreased 3% to $2.3 billion, due to expiration of Abraxane market exclusivity.
- Income tax benefit was $166 million despite pre-tax earnings of $1.9 billion primarily due to the release of income tax reserves. On a non-GAAP basis, the effective tax rate decreased from 15.1% to 10.9% primarily due to the release of income tax reserves, partially offset by jurisdictional earnings mix.
- The company reported net earnings attributable to Bristol Myers Squibb of $2.0 billion, or $0.95 per share, compared to $2.4 billion, or $1.07 per share. In addition to the items discussed above, the net earnings include the impact of fair value adjustments on equity investments in both periods.
- The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $3.9 billion, or $1.82 per share, compared to non-GAAP net earnings of $4.1 billion, or $1.84 per share.
- In addition to the items discussed above, the earnings per share results in 2022 include the impact of lower weighted-average common shares outstanding
FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS
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$ amounts in millions |
|
|
|
|
|
|
Quarter Ended |
Quarter Ended |
% Change from |
% Change from
2021 (Excl. F/X |
|
In-Line Products |
|
|
|
|
|
$2,688 |
$2,671 |
1% |
6% |
|
|
$2,216 |
$1,988 |
11% |
16% |
|
|
$877 |
$854 |
3% |
6% |
|
|
$913 |
$864 |
6% |
9% |
|
|
$578 |
$555 |
4% |
8% |
|
|
$568 |
$545 |
4% |
9% |
|
|
$71 |
$81 |
(12)% |
(7)% |
|
|
Mature and Other Products* |
$411 |
$441 |
(7)% |
(2)% |
|
Total In-Line Products Revenue |
$8,322 |
$7,999 |
4% |
9% |
|
New Product Portfolio |
|
|
|
|
|
$199 |
$151 |
32% |
34% |
|
|
$125 |
$69 |
81% |
87% |
|
|
$104 |
— |
N/A |
N/A |
|
|
$79 |
$48 |
65% |
69% |
|
|
$55 |
$40 |
38% |
48% |
|
|
$37 |
$25 |
48% |
52% |
|
|
$23 |
$20 |
15% |
15% |
|
|
$16 |
— |
N/A |
N/A |
|
|
$7 |
— |
N/A |
N/A |
|
|
Total New Product Portfolio |
$645 |
$353 |
83% |
87% |
|
Total In-Line Products and New Product Portfolio Revenue |
$8,967 |
$8,352 |
7% |
12% |
|
Recent LOE Products |
|
|
|
|
|
$2,260 |
$3,328 |
(32)% |
(31)% |
|
|
$179 |
$305 |
(41)% |
(39)% |
|
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Total Recent LOE Products |
$2,439 |
$3,633 |
(33)% |
(32)% |
|
Total Revenue |
$11,406 |
$11,985 |
(5)% |
(1)% |
* Includes over-the-counter (OTC) products, royalty revenue and other mature products.
** See “Use of Non-GAAP Financial Information.”
FOURTH QUARTER REVENUE HIGHLIGHTS
In-Line Products
Revenues for in-line products were $8.3 billion compared to $8.0 billion, representing an increase of 4%, or 9% when adjusted for foreign exchange. In-line products revenue was largely driven by:
- Eliquis revenues grew 1%, or 6% when adjusted for foreign exchange. U.S. revenues were $1.7 billion compared to $1.5 billion, representing an increase of 15% driven primarily by demand growth and favorable gross to net adjustments. International revenues were $970 million compared to $1.2 billion, representing a decrease of 17% driven by foreign exchange impacts and lower average net selling prices. When adjusted for foreign exchange impacts, Eliquis’ international revenues declined 6%.
- Opdivo revenues increased 11%, or 16% when adjusted for foreign exchange. U.S. revenues were $1.3 billion compared to $1.1 billion, representing an increase of 13% driven by higher demand for our newer metastatic and adjuvant indications, partially offset by declining second-line eligibility across tumors and increased competition. International revenues were $951 million compared to $868 million, representing an increase of 10% driven by higher demand as a result of launches for additional indications and core indications and timing of shipments, partially offset by foreign exchange impacts. When adjusted for foreign exchange impacts, Opdivo’s international revenues increased 20%.
New Product Portfolio
- New product portfolio revenues grew to $645 million compared to $353 million, representing growth of 83% driven by the launch of Opdualag and higher demand for Abecma and Reblozyl. Excluding foreign exchange, new product portfolio revenues grew 87%.
Recent LOE Products
- Revlimid revenues declined by 32% primarily due to lower demand as a result of generic erosion.
FOURTH QUARTER PRODUCT AND PIPELINE UPDATE
Hematology
|
Category |
Asset |
Milestone |
|
Regulatory |
Reblozyl®* (luspatercept) |
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Reblozyl as a treatment for adult patients with anemia associated with non transfusion-dependent beta thalassemia. Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021. |
|
|
Breyanzi® (lisocabtagene maraleucel) |
Japan’s Ministry of Health, Labour and Welfare approved Breyanzi for use in the second-line treatment of patients with relapsed or refractory large B-cell lymphoma regardless of whether autologous hematopoietic stem-cell transplantation is intended. The approval is based on the results of clinical trials in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma after first-line therapy, including global Phase III clinical trials (JCAR017-BCM-003) in patients intended for autologous hematopoietic stem-cell transplantation, Phase II clinical trials (017006) in the United States in patients not intended for autologous hematopoietic stem-cell transplantation, and cohort 2 of Phase II clinical trials (JCAR017- BCM-001) in Europe and Japan. |
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Clinical & Research |
Breyanzi* |
Positive topline results from the Phase 2 portion of the TRANSCEND CLL 004, a Phase 1/2, open-label, single-arm, multicenter study evaluating Breyanzi in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma, showed that the study met the primary endpoint of complete response rate compared to historical control. No new safety signals were reported for Breyanzi in this study. |
|
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Reblozyl |
Phase 3 COMMANDS trial met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in red blood cell transfusion independence with concurrent hemoglobin increase in the first-line treatment of adults with very low-, low-, or intermediate-risk myelodysplastic syndromes who require red blood cell transfusions. No new safety signals were reported. |
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Pipeline |
Multiple Myeloma Portfolio |
In December, the company presented new data from across its multiple myeloma portfolio at the 64th American Society of Hematology Annual Meeting and Exposition, including: |
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Abecma(R) (idecabtagene vicleucel) |
|
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alnuctamab |
|
|
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GPRC5D CAR T (BMS-986393/ CC-95266) |
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mezigdomide |
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|
|
iberdomide |
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Immunology
|
Category |
Asset |
Milestone |
|
Regulatory |
SotyktuTM* (deucrava- citinib) |
The CHMP of the EMA has recommended the approval of Sotyktu for the treatment of adults with moderate-to-severe plaque psoriasis. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. |
|
Clinical & Research |
Zeposia® (ozanimod) |
New retrospective analyses from the ongoing Phase 3 DAYBREAK open-label extension (OLE) study of Zeposia in relapsing multiple sclerosis showed that more than 92% of participants who received Zeposia mounted a serological response following COVID-19 vaccination. Interim analyses of the ongoing Phase 3 DAYBREAK OLE study showed that 68% of participants were relapse-free at up to 74 months of treatment. Post hoc analyses of the Phase 3 SUNBEAM, RADIANCE and DAYBREAK OLE studies demonstrated that a greater proportion of patients treated with Zeposia versus interferon beta-1a had a lower annualized rate of brain volume loss. |
*Announced in January 2023.
FULL YEAR FINANCIAL RESULTS
All comparisons are made versus the same period in 2021 unless otherwise stated.
- Bristol Myers Squibb posted revenues of $46.2 billion, consistent with the prior year, driven by in-line products (primarily Eliquis and Opdivo) and our new product portfolio (primarily Opdualag, Abecma and Reblozyl), offset by recent LOE products (primarily Revlimid) and foreign exchange. When adjusted for foreign exchange, revenues increased 3%. Our in-line products and new product portfolio increased 9% to $35.4 billion, or 13% when adjusted for foreign exchange.
- U.S. revenues increased 9% to $31.8 billion. International revenues decreased 17% to $14.3 billion. When adjusted for foreign exchange, international revenues decreased 8%, primarily due to lower demand for Revlimid as a result of generic erosion, partially offset by in-line products (primarily Opdivo) and our new product portfolio.
- Gross margin decreased from 78.6% to 78.0% and decreased from 79.9% to 78.8% on a non- GAAP basis primarily due to product mix, higher manufacturing costs, partially offset by foreign exchange.
- On a GAAP basis, marketing, selling and administrative expenses increased 2% to $7.8 billion. On a non-GAAP basis, marketing, selling and administrative expenses increased 1% to $7.7 billion.
- On a GAAP basis, research and development expenses decreased 7% to $9.5 billion primarily due to an IPRD impairment charge in 2021. On a non-GAAP basis, research and development expenses decreased 2% to $9.2 billion.
- Acquired IPRD expenses decreased from $1.2 billion to $815 million. Acquired IPRD in 2022 was primarily related to a buyout of a future royalty obligation related to mavacamten and upfront and milestone charges relating to Dragonfly licensing arrangement. Acquired IPRD in 2021 was primarily related to a collaboration agreement with Eisai and Agenus licensing transaction.
- Amortization of acquired intangible assets decreased 4% to $9.6 billion, due to a change in the expected expiration of the market exclusivity period for Pomalyst to the first quarter of 2026 and the expiration of Abraxane market exclusivity.
- The GAAP effective tax rate increased from 13.4% to 17.7% primarily due to an income tax benefit of $1.0 billion in 2021 related to internal transfers of certain intangible assets, partially offset by the release of income tax reserves and jurisdictional earnings mix. The non-GAAP effective tax rate decreased from 16.0% to 15.3% for the full year primarily due to the release of income tax reserves, partially offset by jurisdictional earnings mix.
- The company reported net earnings attributable to Bristol Myers Squibb of $6.3 billion, or $2.95 per share, compared to $7.0 billion, or $3.12 per share. In addition to the items discussed above, the net earnings include the impact of fair value adjustments on equity investments in both periods and contingent value rights in 2021.
- The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $16.5 billion, or $7.70 per share, compared to non-GAAP net earnings of $16.1 billion, or $7.16 per share. In addition to the items discussed above, the earnings per share results in 2022 include the impact of lower weighted-average common shares outstanding.
Beginning with the first quarter of 2022, 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 are no longer excluded from non-GAAP results. These R&D charges that were previously specified are now presented in a new financial statement line item labeled Acquired IPRD. GAAP and non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income of ($0.01) per share in the fourth quarter for both periods. GAAP and non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income of ($0.24) per share in full-year 2022 and ($0.40) per share in full-year 2021. For purposes of comparability, the non-GAAP financial results for the fourth quarter of 2021 have been updated to reflect this change. A discussion of the non- GAAP financial measures is included under the “Use of Non-GAAP Financial Information” section.
FULL YEAR PRODUCT REVENUE HIGHLIGHTS
|
$ amounts in millions |
|
|
|
|
|
|
Full Year Ended |
Full Year Ended |
% Change from |
% Change from |
|
In-Line Products |
|
|
|
|
|
$11,789 |
$10,762 |
10% |
14% |
|
|
$8,249 |
$7,523 |
10% |
14% |
|
|
$3,497 |
$3,332 |
5% |
8% |
|
|
$3,464 |
$3,306 |
5% |
8% |
|
|
$2,165 |
$2,117 |
2% |
6% |
|
|
$2,131 |
$2,026 |
5% |
10% |
|
|
$296 |
$334 |
(11)% |
(7)% |
|
|
Mature and Other Products* |
$1,749 |
$1,900 |
(8)% |
(5)% |
|
Total In-Line Products Revenues |
$33,340 |
$31,300 |
7% |
11% |
|
New Product Portfolio |
|
|
|
|
|
$717 |
$551 |
30% |
32% |
|
|
$388 |
$164 |
** |
** |
|
|
$252 |
— |
N/A |
N/A |
|
|
$250 |
$134 |
87% |
93% |
|
|
$182 |
$87 |
** |
** |
|
|
$124 |
$73 |
70% |
74% |
|
|
$85 |
$74 |
15% |
16% |
|
|
$24 |
— |
N/A |
N/A |
|
|
$8 |
— |
N/A |
N/A |
|
|
Total New Product Portfolio |
$2,030 |
$1,083 |
87% |
92% |
|
Total In-Line Products and New Product Portfolio Revenues |
$35,370 |
$32,383 |
9% |
13% |
|
Recent LOE Products |
|
|
|
|
|
$9,978 |
$12,821 |
(22)% |
(21)% |
|
|
$811 |
$1,181 |
(31)% |
(30)% |
|
|
Total Recent LOE Products |
$10,789 |
$14,002 |
(23)% |
(22)% |
|
Total Revenue |
$46,159 |
$46,385 |
— |
3% |
* Includes OTC products, royalty revenue and other mature products.
** In excess of +100%.
*** See “Use of Non-GAAP Financial Information.”
FULL YEAR REVENUE HIGHLIGHTS
In-Line Products
Revenues for in-line products were $33.3 billion compared to $31.3 billion, representing an increase of 7% or 11% when adjusted for foreign exchange. In-line products revenue was largely driven by:
- Eliquis revenues grew 10%, or 14% when adjusted for foreign exchange. U.S. revenues were $7.8 billion compared to $6.5 billion, representing an increase of 21% driven primarily by favorable gross to net adjustments and demand growth. International revenues were $4.0 billion compared to $4.3 billion, representing a decrease of 7% driven primarily by foreign exchange impacts and lower average net selling prices. When adjusted for foreign exchange impacts, Eliquis’ international revenues increased 4%.
- Opdivo revenues increased 10%, or 14% when adjusted for foreign exchange. U.S. revenues were $4.8 billion compared to $4.2 billion, representing an increase of 15% driven by higher demand for our newer metastatic and adjuvant indications, partially offset by declining second-line eligibility across tumors and increased competition. International revenues were $3.4 billion compared to $3.3 billion, representing an increase of 3% driven by higher demand as a result of launches for additional indications and core indications, partially offset by foreign exchange impacts. When adjusted for foreign exchange impacts, Opdivo’s international revenues increased 14%.
New Product Portfolio
- New product portfolio revenues grew to $2.0 billion compared to $1.1 billion, representing growth of 87% driven by the launch of Opdualag and higher demand for Abecma and Reblozyl. Excluding foreign exchange, new product portfolio revenues grew 92%.
Recent LOE Products
- Revlimid revenues declined by 22% primarily due to lower demand as a result of generic erosion.
Environmental, Social & Governance (ESG)
As a leading biopharma 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 provides its 2023 GAAP EPS guidance range of $4.03 – $4.33 and its non-GAAP EPS guidance range of $7.95 – $8.25. Key 2023 GAAP and non-GAAP line-item guidance assumptions are:
-
Total revenues are expected to increase by approximately 2% at reported rates and approximately 2% excluding foreign exchange.
- Revenues from Revlimid are expected to be approximately $6.5 billion.
- Gross margin is expected to be approximately 77% for GAAP and for non-GAAP.
- Operating expenses1 are expected to decrease by mid-single digits for GAAP and decrease by low single digits for non-GAAP.
- An effective tax rate of approximately 22% for GAAP and approximately 17% for non-GAAP.
1 Consists of MS&A and R&D, excluding Acquired IPRD and Amortization of acquired intangible assets.
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 in the future we quantify 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 at 9:00 a.m. ET during which company executives will review 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, conference 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 on 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.
Contacts
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Investor Relations: [email protected]