8-K
BRISTOL MYERS SQUIBB CO (BMY)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________________
FORM 8-K
_____________________________
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 27, 2023
_____________________________
BRISTOL-MYERS SQUIBB COMPANY
(Exact name of registrant as specified in its charter)
_____________________________
| Delaware | 001-01136 | 22-0790350 |
|---|---|---|
| (State or other jurisdiction of<br>incorporation or organization) | (Commission File Number) | (I.R.S Employer<br>Identification No.) |
430 E. 29th Street, 14th Floor
New York, New York, 10016
(Address of principal executive offices) (zip code)
Registrant’s telephone number, including area code: (212) 546-4200
_____________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, $0.10 Par Value | BMY | New York Stock Exchange |
| 1.000% Notes due 2025 | BMY25 | New York Stock Exchange |
| 1.750% Notes due 2035 | BMY35 | New York Stock Exchange |
| Celgene Contingent Value Rights | CELG RT | New York Stock Exchange |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 Results of Operations and Financial Condition. |
|---|
On April 27, 2023, Bristol-Myers Squibb Company (the “Company”) issued a press release (the “Earnings Press Release”) announcing its financial results for the first quarter of 2023. A copy of the Earnings Press Release is furnished pursuant to this Item 2.02 as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein in its entirety.
| Item 7.01 Regulation FD Disclosure. |
|---|
On April 27, 2023, the Company posted on its website at www.bms.com a presentation (the “Bristol Myers Presentation”) on certain financial and operating initiatives available for viewing during the Company’s conference call and webcast announcing its financial results for the first quarter of 2023 at 8:00 a.m. Eastern time on April 27, 2023. A copy of the Bristol Myers Presentation is furnished pursuant to this Item 7.01 as Exhibit 99.2 to this Current Report on Form 8-K and incorporated by reference herein in its entirety. The Earnings Press Release and the Bristol Myers Presentation include references to non-GAAP financial information. Reconciliations between the non-GAAP financial measures and the comparable GAAP financial measures and the reasons for the presentation of such non-GAAP financial measures, are available in the Earnings Press Release which is included as Exhibit 99.1 hereto. The Bristol Myers Presentation should be read in conjunction with the Earnings Press Release. The Company reserves the right to discontinue availability of the Bristol Myers Presentation from its website at any time.
Pursuant to General Instruction B.2. to Form 8-K, the information set forth in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1, and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities thereof, nor shall it be incorporated by reference into future filings by the Company under the Exchange Act or under the Securities Act of 1933, as amended, except to the extent specifically provided in any such filing. Additionally, the submission of the information set forth in this Item 7.01 is not deemed an admission as to the materiality of any information in this Current Report on Form 8-K that is required to be disclosed solely by Regulation FD.
| Item 9.01 Financial Statements and Exhibits. |
|---|
(d) Exhibits
The following exhibits are furnished as part of this Current Report on Form 8-K:
| Exhibit<br>No. | Description |
|---|---|
| 99.1 | Press release of Bristol-Myers Squibb Company dated April 27, 2023. |
| 99.2 | Presentation Materials of Bristol-Myers Squibb Company dated April 27, 2023. |
| 104 | The cover page from this Current Report on Form 8-K formatted in Inline XBRL (included as Exhibit 101). |
EXHIBIT INDEX
| Exhibit<br>No. | Description |
|---|---|
| 99.1 | Press release of Bristol-Myers Squibb Company dated April 27, 2023. |
| 99.2 | Presentation Materials of Bristol-Myers Squibb Company dated April 27, 2023. |
| 104 | The cover page from this Current Report on Form 8-K formatted in Inline XBRL (included as Exhibit 101). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| BRISTOL-MYERS SQUIBB COMPANY | ||
|---|---|---|
| Dated: April 27, 2023 | By: | /s/ Kimberly M. Jablonski |
| Name: | Kimberly M. Jablonski | |
| Title: | Corporate Secretary |
Document
Exhibit 99.1
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
(NEW YORK, April 27, 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.”
| amounts in millions, except per share amounts | 2022 | Change | Change Excl. F/X** | ||
| Total Revenues | $11,648 | (3) | % | (1) | % |
| Earnings per share - GAAP* | 0.59 | 81 | % | N/A | |
| Earnings per share - Non-GAAP* | 1.96 | 5 | % | N/A | |
| * GAAP and non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income of (0.01) in 2023 compared to (0.10) per share in 2022. | |||||
| ** See "Use of Non-GAAP Financial Information". |
All values are in US Dollars.
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 $1.96 per share, for the same period a year ago.
•In addition to the items discussed above, the earnings per share results in the first quarter of 2023 include the impact of lower weighted-average common shares outstanding.
FIRST QUARTER PRODUCT REVENUE HIGHLIGHTS
| ($ amounts in millions) | Quarter Ended March 31, 2023 | % Change from Quarter Ended March 31, 2022 | % Change from Quarter Ended March 31, 2022 (Excl. F/X) ** | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| U.S.(c) | Int'l | WW(d) | U.S.(c) | Int'l | WW(d) | Int'l | WW(d) | |||||||||
| In-Line Products | ||||||||||||||||
| Eliquis | $ | 2,554 | $ | 869 | $ | 3,423 | 19 | % | (18) | % | 7 | % | (13) | % | 8 | % |
| Opdivo | 1,290 | 912 | 2,202 | 17 | % | 11 | % | 15 | % | 18 | % | 17 | % | |||
| Pomalyst/Imnovid | 545 | 287 | 832 | (2) | % | 7 | % | 1 | % | 12 | % | 2 | % | |||
| Orencia | 562 | 202 | 764 | (5) | % | 1 | % | (4) | % | 10 | % | (1) | % | |||
| Sprycel | 295 | 134 | 429 | (3) | % | (25) | % | (11) | % | (19) | % | (9) | % | |||
| Yervoy | 314 | 194 | 508 | 1 | % | (5) | % | (1) | % | 3 | % | 2 | % | |||
| Mature and other products (a) | 182 | 285 | 467 | 1 | % | (20) | % | (13) | % | (16) | % | (10) | % | |||
| Total In-Line Products | 5,742 | 2,883 | 8,625 | 11 | % | (7) | % | 4 | % | (1) | % | 6 | % | |||
| New Product Portfolio | ||||||||||||||||
| Reblozyl | 158 | 48 | 206 | 18 | % | * | 32 | % | * | 33 | % | |||||
| Abecma | 118 | 29 | 147 | * | * | * | * | * | ||||||||
| Opdualag | 116 | 1 | 117 | * | N/A | * | N/A | * | ||||||||
| Zeposia | 52 | 26 | 78 | * | 73 | % | * | 80 | % | * | ||||||
| Breyanzi | 58 | 13 | 71 | 41 | % | * | 61 | % | * | 66 | % | |||||
| Onureg | 25 | 9 | 34 | 32 | % | * | 48 | % | * | 52 | % | |||||
| Inrebic | 17 | 8 | 25 | 13 | % | * | 39 | % | * | 39 | % | |||||
| Camzyos | 29 | — | 29 | N/A | N/A | N/A | N/A | N/A | ||||||||
| Sotyktu | 15 | 1 | 16 | N/A | N/A | N/A | N/A | N/A | ||||||||
| Total New Product Portfolio | 588 | 135 | 723 | * | * | * | * | * | ||||||||
| Total In-Line and New Product Portfolio | 6,330 | 3,018 | 9,348 | 15 | % | (4) | % | 8 | % | 2 | % | 10 | % | |||
| Recent LOE Products (b) | ||||||||||||||||
| Revlimid | 1,541 | 209 | 1,750 | (24) | % | (72) | % | (37) | % | (71) | % | (37) | % | |||
| Abraxane | 162 | 77 | 239 | (6) | % | 88 | % | 12 | % | * | 14 | % | ||||
| Total Recent LOE Products | 1,703 | 286 | 1,989 | (23) | % | (64) | % | (34) | % | (62) | % | (33) | % | |||
| Total Revenues | $ | 8,033 | $ | 3,304 | $ | 11,337 | 4 | % | (16) | % | (3) | % | (11) | % | (1) | % |
* In excess of +100%
** See "Use of Non-GAAP Financial Information".
(a) Includes over-the-counter (OTC) products, royalty revenue and mature products.
(b) Recent LOE Products includes products with significant expected decline in revenue from a prior reporting period as a result of a loss of exclusivity.
(c) Includes Puerto Rico.
(d) Worldwide (WW) includes International (Int'l) and U.S.
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
| Category | Asset | Milestone |
|---|---|---|
| Regulatory | Camzyos®<br><br>(mavacamten) | The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Camzyos for the treatment of symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy (HCM) in adult patients. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP opinion. The positive opinion is based upon efficacy and safety results from two Phase 3 trials, EXPLORER-HCM and VALOR-HCM. |
| Clinical & Research | milvexian | The company, in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, launched the Phase 3 Librexia program studying milvexian, an investigational oral factor XIa inhibitor (antithrombotic).The Librexia program will provide important data across three indication-seeking studies: Librexia STROKE for antiplatelet therapy for stroke prevention in acute ischemic stroke or high-risk transient ischemic stroke, Librexia ACS in addition to antiplatelet therapy for event reduction in acute coronary syndromes and Librexia AF which compares milvexian to apixaban in the prevention of stroke in patients with atrial fibrillation. |
| --- | --- | --- |
Oncology
| Category | Asset | Milestone |
|---|---|---|
| Regulatory | Opdivo® (nivolumab) | The U.S. Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for Opdivo as a monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 13, 2023.<br><br>In addition, the EMA validated the Type II Variation Marketing Authorization Application for Opdivo as a monotherapy in the adjuvant setting for the treatment of patients with completely resected stage IIB or IIC melanoma. The EMA’s validation confirms the submission is complete and begins the start of the EMA’s centralized review process.<br><br>The submissions were based on results from the Phase 3 CheckMate -76K clinical trial. |
| Clinical & Research | Opdivo | Three-year follow-up results from Phase 3 CheckMate -816 trial demonstrated sustained clinical benefits with three cycles of Opdivo in combination with platinum-based chemotherapy for the neoadjuvant treatment of patients with resectable NSCLC. While overall survival (OS) remained immature at this analysis, there was a continued encouraging trend in OS favoring neoadjuvant Opdivo with chemotherapy over chemotherapy alone. |
| Three-year follow-up results from Phase 3 CheckMate -274 trial demonstrated significant sustained clinical benefits with Opdivo for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma. | ||
| Three-year follow-up results from Phase 3 CheckMate -9ER trial demonstrated sustained survival and response rate benefits with the combination of Opdivo and Exelixis Inc.’s CABOMETYX (cabozantinib) versus sunitinib in the first-line treatment of advanced renal cell carcinoma. |
Hematology
| Category | Asset | Milestone |
|---|---|---|
| Regulatory | Abecma®<br><br>(idecabtagene vicleucel) | The FDA has accepted the company's and 2seventy bio's (NASDAQ: TSVT) sBLA for Abecma for the treatment of adults with relapsed or refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The FDA has assigned a PDUFA goal date of December 16, 2023.<br><br><br><br>The EMA also validated the type II variation for the extension of indication for Abecma to treat adults with relapsed or refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.<br><br><br><br>In addition, Japan's Ministry of Health, Labour and Welfare has accepted Bristol Myers Squibb’s supplemental new drug application for Abecma in patients who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, and have experienced disease progression or relapse after the last therapy.<br><br><br><br>The three regulatory applications were based on results from the pivotal Phase 3, open-label, global, randomized, controlled KarMMa-3 clinical trial. |
| Breyanzi®<br><br>(lisocabtagene maraleucel) | The CHMP of the EMA has recommended approval of Breyanzi for the treatment of adult patients with diffuse large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B, who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. The positive opinion was based on results from the pivotal Phase 3 TRANSFORM clinical trial. | |
| Reblozyl®<br><br>(luspatercept-aamt) | The EC granted full Marketing Authorization for Reblozyl for treatment in adult patients of anemia associated with non-transfusion-dependent beta thalassemia. The decision was based on results from the Phase 2 BEYOND trial. Reblozyl is being developed and commercialized through a global collaboration with Merck following Merck’s acquisition of Acceleron Pharma, Inc. in November 2021. | |
| Clinical & Research | Abecma | Positive results from Phase 3 KarMMa-3 Study showed Abecma reduced the risk of disease progression or death by 51% versus standard regimens in earlier lines of therapy for relapsed and refractory multiple myeloma. |
Immunology
| Category | Asset | Milestone |
|---|---|---|
| Regulatory | SotyktuTM<br><br>(deucrava-citinib) | The EC approved Sotyktu, a first-in-class, oral, selective tyrosine kinase 2 inhibitor, for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease. The approval was based on results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials. Additional data from the POETYK PSO long-term extension trial (LTE) also supported approval. |
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:
| U.S. GAAP | Non-GAAP2 | ||||
|---|---|---|---|---|---|
| February<br>(Prior) | |||||
| Total Revenues<br><br>(as reported) | ~2% increase | No change | ~2% increase | No change | |
| Total Revenues<br><br>(excl. F/X) | ~2% increase | No change | ~2% increase | No change | |
| Revlimid | ~6.5 billion | No change | ~6.5 billion | No change | |
| Gross Margin % | ~77% | No change | ~77% | No change | |
| Operating Expenses1 | Mid single-digit decline | No change | Low single-digit decline | No change | |
| Tax Rate | ~22% | ~21% | ~17% | No change | |
| Diluted EPS | 4.03-4.33 | 4.10-4.40 | 7.95-8.25 | No change |
All values are in US Dollars.
1 Operating Expenses = MS&A and R&D, excluding Acquired IPRD and Amortization of acquired intangible assets.
2 See "Use of Non-GAAP Financial Information."
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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For more information, contact:
Media: media@bms.com
Investor Relations: investor.relations@bms.com
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.
BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF EARNINGS
FOR THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022
(Unaudited, dollars and shares in millions except per share data)
| Three Months Ended March 31, | ||||
|---|---|---|---|---|
| 2023 | 2022 | |||
| Net product sales | $ | 11,048 | $ | 11,308 |
| Alliance and other revenues | 289 | 340 | ||
| Total Revenues | 11,337 | 11,648 | ||
| Cost of products sold(a) | 2,566 | 2,471 | ||
| Marketing, selling and administrative | 1,762 | 1,831 | ||
| Research and development | 2,321 | 2,260 | ||
| Acquired IPRD | 75 | 333 | ||
| Amortization of acquired intangible assets | 2,256 | 2,417 | ||
| Other (income)/expense, net | (413) | 649 | ||
| Total Expenses | 8,567 | 9,961 | ||
| Earnings Before Income Taxes | 2,770 | 1,687 | ||
| Provision for Income Taxes | 503 | 404 | ||
| Net Earnings | 2,267 | 1,283 | ||
| Noncontrolling Interest | 5 | 5 | ||
| Net Earnings Attributable to BMS | $ | 2,262 | $ | 1,278 |
| Weighted-Average Common Shares Outstanding: | ||||
| Basic | 2,099 | 2,146 | ||
| Diluted | 2,113 | 2,164 | ||
| Earnings per Common Share: | ||||
| Basic | $ | 1.08 | $ | 0.60 |
| Diluted | 1.07 | 0.59 | ||
| Other (income)/expense, net | ||||
| Interest expense(b) | $ | 288 | $ | 326 |
| Royalty and licensing income | (363) | (306) | ||
| Royalty income - divestitures | (188) | (171) | ||
| Equity investment losses | 155 | 644 | ||
| Integration expenses | 67 | 105 | ||
| Loss on debt redemption | — | 275 | ||
| Divestiture gains | — | (211) | ||
| Litigation and other settlements | (325) | (37) | ||
| Investment income | (102) | (10) | ||
| Provision for restructuring | 67 | 23 | ||
| Other | (12) | 11 | ||
| Other (income)/expense, net | $ | (413) | $ | 649 |
(a) Excludes amortization of acquired intangible assets.
(b) Includes amortization of purchase price adjustments to Celgene debt.
BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUES
FOR THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022
(Unaudited, dollars in millions)
| Change vs. 2022 | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | GAAP | Excl. F/X** | |||||||||||||||||||||
| U.S. (c) | Int'l | WW (d) | U.S. (c) | Int'l | WW (d) | U.S. (c) | Int'l | WW (d) | U.S.(c) | Int'l | WW (d) | |||||||||||||
| In-Line Products | ||||||||||||||||||||||||
| Eliquis | $ | 2,554 | $ | 869 | $ | 3,423 | $ | 2,147 | $ | 1,064 | $ | 3,211 | 19 | % | (18) | % | 7 | % | 19 | % | (13) | % | 8 | % |
| Opdivo | 1,290 | 912 | 2,202 | 1,099 | 824 | 1,923 | 17 | % | 11 | % | 15 | % | 17 | % | 18 | % | 17 | % | ||||||
| Pomalyst/Imnovid | 545 | 287 | 832 | 557 | 269 | 826 | (2) | % | 7 | % | 1 | % | (2) | % | 12 | % | 2 | % | ||||||
| Orencia | 562 | 202 | 764 | 592 | 200 | 792 | (5) | % | 1 | % | (4) | % | (5) | % | 10 | % | (1) | % | ||||||
| Sprycel | 295 | 134 | 429 | 305 | 178 | 483 | (3) | % | (25) | % | (11) | % | (3) | % | (19) | % | (9) | % | ||||||
| Yervoy | 314 | 194 | 508 | 311 | 204 | 515 | 1 | % | (5) | % | (1) | % | 1 | % | 3 | % | 2 | % | ||||||
| Mature and other brands(a) | 182 | 285 | 467 | 180 | 357 | 537 | 1 | % | (20) | % | (13) | % | 1 | % | (16) | % | (10) | % | ||||||
| Total In-Line Products | 5,742 | 2,883 | 8,625 | 5,191 | 3,096 | 8,287 | 11 | % | (7) | % | 4 | % | 11 | % | (1) | % | 6 | % | ||||||
| New Product Portfolio | ||||||||||||||||||||||||
| Reblozyl | 158 | 48 | 206 | 134 | 22 | 156 | 18 | % | * | 32 | % | 18 | % | * | 33 | % | ||||||||
| Abecma | 118 | 29 | 147 | 56 | 11 | 67 | * | * | * | * | * | * | ||||||||||||
| Opdualag | 116 | 1 | 117 | 6 | — | 6 | * | N/A | * | * | N/A | * | ||||||||||||
| Zeposia | 52 | 26 | 78 | 21 | 15 | 36 | * | 73 | % | * | * | 80 | % | * | ||||||||||
| Breyanzi | 58 | 13 | 71 | 41 | 3 | 44 | 41 | % | * | 61 | % | 41 | % | * | 66 | % | ||||||||
| Onureg | 25 | 9 | 34 | 19 | 4 | 23 | 32 | % | * | 48 | % | 32 | % | * | 52 | % | ||||||||
| Inrebic | 17 | 8 | 25 | 15 | 3 | 18 | 13 | % | * | 39 | % | 13 | % | * | 39 | % | ||||||||
| Camzyos | 29 | — | 29 | — | — | — | N/A | N/A | N/A | N/A | N/A | N/A | ||||||||||||
| Sotyktu | 15 | 1 | 16 | — | — | — | N/A | N/A | N/A | N/A | N/A | N/A | ||||||||||||
| Total New Product Portfolio | 588 | 135 | 723 | 292 | 58 | 350 | * | * | * | * | * | * | ||||||||||||
| Total In-Line and New Product Portfolio | 6,330 | 3,018 | 9,348 | 5,483 | 3,154 | 8,637 | 15 | % | (4) | % | 8 | % | 15 | % | 2 | % | 10 | % | ||||||
| Recent LOE Products(b) | ||||||||||||||||||||||||
| Revlimid | 1,541 | 209 | 1,750 | 2,038 | 759 | 2,797 | (24) | % | (72) | % | (37) | % | (24) | % | (71) | % | (37) | % | ||||||
| Abraxane | 162 | 77 | 239 | 173 | 41 | 214 | (6) | % | 88 | % | 12 | % | (6) | % | * | 14 | % | |||||||
| Total Recent LOE Products | 1,703 | 286 | 1,989 | 2,211 | 800 | 3,011 | (23) | % | (64) | % | (34) | % | (23) | % | (62) | % | (33) | % | ||||||
| Total Revenues | $ | 8,033 | $ | 3,304 | $ | 11,337 | $ | 7,694 | $ | 3,954 | $ | 11,648 | 4 | % | (16) | % | (3) | % | 4 | % | (11) | % | (1) | % |
* In excess of +100%
** See "Use of Non-GAAP Financial Information".
(a) Includes over-the-counter (OTC) products, royalty revenue and mature products.
(b) Recent LOE Products includes products with significant expected decline in revenue from a prior reporting period as a result of a loss of exclusivity.
(c) Includes Puerto Rico.
(d) Worldwide (WW) includes International (Int'l) and U.S.
BRISTOL-MYERS SQUIBB COMPANY
INTERNATIONAL AND WORLDWIDE REVENUES
FOREIGN EXCHANGE IMPACT (%)
FOR THE THREE MONTHS ENDED MARCH 31, 2023
(Unaudited)
| International | WW (c) | |||||
|---|---|---|---|---|---|---|
| Change % | Favorable/ (Unfavorable)<br>F/X % | Change % Excl. F/X | Change % | Favorable/ (Unfavorable)<br>F/X % | Change % Excl. F/X** | |
| In-Line Products | ||||||
| Eliquis | (18)% | (5)% | (13)% | 7% | (1)% | 8% |
| Opdivo | 11% | (7)% | 18% | 15% | (2)% | 17% |
| Pomalyst/Imnovid | 7% | (5)% | 12% | 1% | (1)% | 2% |
| Orencia | 1% | (9)% | 10% | (4)% | (3)% | (1)% |
| Sprycel | (25)% | (6)% | (19)% | (11)% | (2)% | (9)% |
| Yervoy | (5)% | (8)% | 3% | (1)% | (3)% | 2% |
| Mature and other products(a) | (20)% | (4)% | (16)% | (13)% | (3)% | (10)% |
| Total In-Line Products | (7)% | (6)% | (1)% | 4% | (2)% | 6% |
| New Product Portfolio | ||||||
| Reblozyl | * | * | * | 32% | (1)% | 33% |
| Abecma | * | * | * | * | * | * |
| Opdualag | N/A | N/A | N/A | * | * | * |
| Zeposia | 73% | (7)% | 80% | * | * | * |
| Breyanzi | * | * | * | 61% | (5)% | 66% |
| Onureg | * | * | * | 48% | (4)% | 52% |
| Inrebic | * | * | * | 39% | — | 39% |
| Camzyos | N/A | N/A | N/A | N/A | N/A | N/A |
| Sotyktu | N/A | N/A | N/A | N/A | N/A | N/A |
| Total New Product Portfolio | * | * | * | * | * | * |
| Total In-Line Products and New Product Portfolio | (4)% | (6)% | 2% | 8% | (2)% | 10% |
| Recent LOE Products(b) | ||||||
| Revlimid | (72)% | (1)% | (71)% | (37)% | — | (37)% |
| Abraxane | 88% | (14)% | * | 12% | (2)% | 14% |
| Total Recent LOE Products | (64)% | (2)% | (62)% | (34)% | (1)% | (33)% |
| Total | (16)% | (5)% | (11)% | (3)% | (2)% | (1)% |
* In excess of +/- 100%.
** See "Use of Non-GAAP Financial Information".
(a) Includes over-the-counter (OTC) products, royalty revenue and other mature products.
(b) Recent LOE products include products with significant expected decline in revenue from a prior reporting period as a result of a loss of exclusivity.
(c) Worldwide (WW) includes International (Int'l) and U.S.
BRISTOL-MYERS SQUIBB COMPANY
SPECIFIED ITEMS
FOR THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022
(Unaudited, dollars in millions)
| Three Months Ended March 31, | ||||
|---|---|---|---|---|
| 2023 | 2022 | |||
| Inventory purchase price accounting adjustments | $ | 53 | $ | 52 |
| Site exit and other costs | 1 | — | ||
| Cost of products sold | 54 | 52 | ||
| Site exit and other costs | — | 2 | ||
| Marketing, selling and administrative | — | 2 | ||
| IPRD impairments | 20 | 40 | ||
| Inventory purchase price accounting adjustments | — | 87 | ||
| Priority review voucher | 95 | — | ||
| Research and development | 115 | 127 | ||
| Amortization of acquired intangible assets | 2,256 | 2,417 | ||
| Interest expense(a) | (14) | (27) | ||
| Equity investment losses/(income) | 150 | 643 | ||
| Integration expenses | 67 | 105 | ||
| Loss on debt redemption | — | 275 | ||
| Divestiture losses/(gains) | — | (211) | ||
| Litigation and other settlements | (335) | (40) | ||
| Provision for restructuring | 67 | 23 | ||
| Other | (5) | — | ||
| Other (income)/expense, net | (70) | 768 | ||
| Increase to pretax income | 2,355 | 3,366 | ||
| Income taxes on items above | (293) | (398) | ||
| Increase to net earnings | $ | 2,062 | $ | 2,968 |
(a) Includes amortization of purchase price adjustments to Celgene debt.
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF CERTAIN GAAP LINE ITEMS TO CERTAIN NON-GAAP LINE ITEMS
FOR THE THREE MONTHS ENDED MARCH 31, 2023 AND 2022
(Unaudited, dollars and shares in millions except per share data)
| Three Months Ended March 31, 2023 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| GAAP | Specified Items(a) | Non-GAAP | |||||||
| Gross profit | $ | 8,771 | $ | 54 | $ | 8,825 | |||
| Marketing, selling and administrative | 1,762 | — | 1,762 | ||||||
| Research and development | 2,321 | (115) | 2,206 | ||||||
| Amortization of acquired intangible assets | 2,256 | (2,256) | — | ||||||
| Other (income)/expense, net | (413) | 70 | (343) | ||||||
| Earnings before income taxes | 2,770 | 2,355 | 5,125 | ||||||
| Provision for income taxes | 503 | 293 | 796 | ||||||
| Net earnings attributable to BMS used for diluted EPS calculation | $ | 2,262 | $ | 2,062 | $ | 4,324 | |||
| Weighted-average common shares outstanding - diluted | 2,113 | 2,113 | 2,113 | ||||||
| Diluted earnings per share | $ | 1.07 | $ | 0.98 | $ | 2.05 | |||
| Effective tax rate | 18.2 | % | (2.7) | % | 15.5 | % | |||
| Three Months Ended March 31, 2022 | |||||||||
| GAAP | Specified Items(a) | Non-GAAP | |||||||
| Gross profit | $ | 9,177 | $ | 52 | $ | 9,229 | |||
| Marketing, selling and administrative | 1,831 | (2) | 1,829 | ||||||
| Research and development | 2,260 | (127) | 2,133 | ||||||
| Amortization of acquired intangible assets | 2,417 | (2,417) | — | ||||||
| Other (income)/expense, net | 649 | (768) | (119) | ||||||
| Earnings before income taxes | 1,687 | 3,366 | 5,053 | ||||||
| Provision for income taxes | 404 | 398 | 802 | ||||||
| Net earnings attributable to BMS used for diluted EPS calculation | $ | 1,278 | $ | 2,968 | $ | 4,246 | |||
| Weighted-average common shares outstanding - diluted | 2,164 | 2,164 | 2,164 | ||||||
| Diluted earnings per share | $ | 0.59 | $ | 1.37 | $ | 1.96 | |||
| Effective tax rate | 23.9 | % | (8.0) | % | 15.9 | % |
(a) Refer to the Specified Items schedule above for further details. Effective tax rate on the Specified Items represents the difference between the GAAP and Non-GAAP effective tax rate.
BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF GAAP AND NON-GAAP GROWTH DOLLARS AND PERCENTAGES EXCLUDING FOREIGN EXCHANGE IMPACT
FOR THE PERIOD ENDED MARCH 31, 2023
(Unaudited, dollars in millions)
| 2023 | 2022 | Change | Change % | Favorable / (Unfavorable) F/X * | 2023 Excl. F/X** | Favorable / (Unfavorable) F/X %* | % Change Excl. F/X** | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Revenues | $ | 11,337 | $ | 11,648 | (3) | % | $ | 11,548 | (2) | % | (1) | % | ||||
| Gross profit | 8,771 | 9,177 | (406) | (4) | % | N/A | N/A | N/A | N/A | |||||||
| Gross profit excluding specified items(a) | 8,825 | 9,229 | (404) | (4) | % | N/A | N/A | N/A | N/A | |||||||
| Gross margin(b) | 77.4 | % | 78.8 | % | ||||||||||||
| Gross margin excluding specified items | 77.8 | % | 79.2 | % | ||||||||||||
| Marketing, selling and administrative | 1,762 | 1,831 | (69) | (4) | % | 31 | 1,793 | 2 | % | (2) | % | |||||
| Marketing, selling and administrative excluding specified items(a) | 1,762 | 1,829 | (67) | (4) | % | 31 | 1,793 | 2 | % | (2) | % | |||||
| Marketing, selling and administrative excluding specified items as a % of revenues | 15.5 | % | 15.7 | % | ||||||||||||
| Research and development | 2,321 | 2,260 | 61 | 3 | % | 16 | 2,337 | — | 3 | % | ||||||
| Research and development excluding specified items(a) | 2,206 | 2,133 | 73 | 3 | % | 16 | 2,222 | 1 | % | 4 | % | |||||
| Research and development excluding specified items as a % of revenues | 19.5 | % | 18.3 | % |
All values are in US Dollars.
* Foreign exchange impacts were derived 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.
** See "Use of Non-GAAP Financial Information".
(a) Refer to the Specified Items schedule above for further details.
(b) Represents gross profit as a percentage of Revenues.
BRISTOL-MYERS SQUIBB COMPANY
NET DEBT CALCULATION
AS OF MARCH 31, 2023 AND DECEMBER 31, 2022
(Unaudited, dollars in millions)
| March 31,<br>2023 | December 31,<br>2022 | |||
|---|---|---|---|---|
| Cash and cash equivalents | $ | 8,995 | $ | 9,123 |
| Marketable debt securities - current | 274 | 130 | ||
| Cash, cash equivalents and marketable debt securities | 9,269 | 9,253 | ||
| Short-term debt obligations | (2,752) | (4,264) | ||
| Long-term debt | (35,078) | (35,056) | ||
| Net debt position | $ | (28,561) | $ | (30,067) |
BRISTOL-MYERS SQUIBB COMPANY
2023 FULL YEAR PROJECTED DILUTED EPS FROM OPERATIONS
EXCLUDING PROJECTED SPECIFIED ITEMS
| Full Year 2023 | ||||
|---|---|---|---|---|
| Pre-tax | Tax | After-tax | ||
| Projected Diluted Earnings Attributable to Shareholders per Common Share - GAAP(a) | $4.10 to $4.40 | |||
| Projected Specified Items: | ||||
| Purchase price accounting adjustments(a) | 4.27 | 0.54 | 3.73 | |
| Acquisition, restructuring and integration expenses(b) | 0.17 | 0.03 | 0.14 | |
| Equity investment losses | 0.07 | 0.01 | 0.06 | |
| Priority review voucher | 0.04 | 0.01 | 0.03 | |
| Intangible asset impairment | 0.01 | — | 0.01 | |
| Litigation and other settlements | (0.16) | (0.04) | (0.12) | |
| Total | 4.40 | 0.55 | 3.85 | |
| Projected Diluted Earnings Attributable to Shareholders per Common Share - Non-GAAP(a) | $7.95 to $8.25 |
(a) Includes amortization of acquired intangible assets, unwind of inventory fair value adjustments and amortization of fair value adjustments of debt assumed from Celgene.
(b) Includes acquisition, restructuring and integration expenses recognized in Other (income)/expense, net.
| The following table summarizes the company's 2023 financial guidance: | ||
|---|---|---|
| Line item | GAAP | Non-GAAP |
| Total reported revenues | ~ 2% increase | ~ 2% increase |
| Total revenues Ex-Fx (c) | ~ 2% increase | ~ 2% increase |
| Revlimid | ~$6.5 billion | ~$6.5 billion |
| Gross margin % | ~ 77% | ~ 77% |
| Operating expenses(d) | Mid single-digit decline | Low single-digit decline |
| Effective tax rate | ~ 21% | ~ 17% |
(c) Ex-FX excludes the impact of foreign exchange calculated by converting our current-period local currency financial results using the prior period average currency rates and comparing these adjusted amounts to our prior-period results.
(d) Operating expenses consist of Marketing, selling and administrative expenses and Research and development expenses, excluding Acquired IPRD expenses.
| 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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Q1 2023 Results April 27, 2023
Q1 2023 Results Not for Product Promotional Use Forward Looking Statements and Non-GAAP Financial Information 2 This presentation contains statements about Bristol-Myers Squibb Company’s (the “Company”) future financial results, plans, business development strategy, anticipated clinical trials, results and regulatory approvals that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Actual results may differ materially from those expressed in, or implied by, these statements as a result of various factors, including, but not limited to, (i) new laws and regulations, (ii) our ability to obtain, protect and maintain market exclusivity rights and enforce patents and other intellectual property rights, (iii) our ability to achieve expected clinical, regulatory and contractual milestones on expected timelines or at all, (iv) difficulties or delays in the development and commercialization of new products, (v) difficulties or delays in our clinical trials and the manufacturing, distribution and sale of our products, (vi) adverse outcomes in legal or regulatory proceedings, (vii) risks relating to acquisitions, divestitures, alliances, joint ventures and other portfolio actions and (viii) political and financial instability, including changes in general economic conditions. These and other important factors are discussed in the Company’s most recent annual report on Form 10-K and reports on Forms 10-Q and 8-K. These documents are available on the U.S. Securities and Exchange Commission’s website, on the Company’s website or from Bristol-Myers Squibb Investor Relations. No forward-looking statements can be guaranteed. In addition, any forward-looking statements and clinical data included herein are presented only as of the date hereof. Except as otherwise required by applicable law, the Company undertakes no obligation to publicly update any of the provided information, whether as a result of new information, future events, changed circumstances or otherwise. This presentation includes certain non-generally accepted accounting principles (“GAAP”) financial measures that we use to describe the Company’s performance. The non-GAAP financial measures are provided as supplemental information 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’s, analysts’ and investors’ overall understanding of the Company’s underlying financial performance and trends and facilitate comparisons among current, past and future periods. This presentation also provides certain revenues and expenses 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. The non-GAAP information presented herein provides investors with additional useful information but should not be considered in isolation or as substitutes for the related GAAP measures. Moreover, other companies may define non-GAAP measures differently, which limits the usefulness of these measures for comparisons with such other companies. We encourage investors to review our financial statements and publicly filed reports in their entirety and not to rely on any single financial measure. An explanation of these non-GAAP financial measures and a reconciliation to the most directly comparable financial measure are available on our website at www.bms.com/investors. 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 a comparable GAAP measure 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, without unreasonable effort, 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. In addition, the Company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results.
Giovanni Caforio, MD Chairman of the Board and Chief Executive Officer 3 Q1 2023 Results
Q1 2023 Results Not for Product Promotional Use Q1 2023 Performance 4 Strong Commercial Execution Global Net Sales Q1:~$11.3B (3%) YoY; (1%) Ex-FX* Earnings Per Share (EPS) Q1: GAAP $1.07, +81% YoY Non-GAAP* $2.05, +5% YoY Strong Financial Execution In-Line Brands & New Product Portfolio: +8% YoY; +10% Ex-FX*Q1:~$9.3B 2023 Guidance Total Sales1* Affirmed Non-GAAP EPS* Reflects continued top & bottom-line growth ~2% YoY Growth $7.95 - $8.25 $4.10 - $4.40Increased GAAP EPS* New Product Performance $350 $723 Q1 2022 Q1 2023 Revenues more than doubled vs prior year *See “Forward-Looking Statements and Non-GAAP Financial Information” 1Sales growth on reported & Ex-FX* basis $ in millions
Q1 2023 Results Not for Product Promotional Use Near-term Catalysts Across Diversified Portfolio 5 1CD PoC not achieved; awaiting higher dose UC Ph2 data to inform future IBD development plans; 2EU CHMP Positive Opinion; 3SSP, ACS, AF trials conducted by Janssen 2023 Key Milestones Opdivo (+/- Yervoy) Early Stage: Neo-adjuvant NSCLC Ph3 (CM-816) approval in EU Metastatic 1L mCRPC Ph3 (CM-7DX) Opdualag 1L NSCLC Ph2 repotrectinib ROS1+ NSCLC (TRIDENT-1) U.S. filing Abecma 3-5L MM Ph3 (KarMMa-3) filing Initiation NDMM Ph3 (KarMMa-9) Breyanzi 2L TE LBCL EU approval 3L+ CLL Ph1/2 (TRANSCEND-CLL) 3L+ FL Ph2 (TRANSCEND- FL) iberdomide Initiation of pivotal post-transplant maintenance H2H vs Revlimid Reblozyl 1L MDS (COMMANDS) U.S. filing Sotyktu Mod-to-severe PsO EU approval CD Ph2 (IM011-023)1 UC Ph2 (IM011-127) LPA1 Antagonist Initiation IPF Ph3 PPF Ph2 (IM027-040) Camzyos oHCM EU approval2 LIBREXIA (milvexian) Initiation Ph3 program3 2024/2025 Key Milestones Opdivo (+/- Yervoy) Metastatic: 1L HCC Ph3 (CM-9DW) 1L+ MSI High CRC Ph3 (CM-8HW) Early Stage: Peri-adj NSCLC Ph3 (CM-77T) Peri-adj MIBC Ph3 (CM-078) Adj HCC Ph3 (CM-9DX) Stage III Unresectable NSCLC Ph3 (CM-73L) Adj NSCLC Ph3 (ANVIL, co-op group) Opdualag 1L HCC Ph2 2L+ HCC Ph2 2L/3L+ MSS mCRC Ph3 alnuctamab BCMA TCE Initiation MM Ph3 Reblozyl 1L MF Ph3 (INDEPENDENCE) cendakimab EoE Ph3 Sotyktu PsA Ph3 Zeposia CD maintenance Ph3 (YELLOWSTONE) Milestones represent data readouts unless otherwise specified; subject to positive registrational trials and health authority approval
Q1 2023 Results Not for Product Promotional Use • Camzyos nHCM • Sotyktu SLE • Opdualag 1L NSCLC Breyanzi 3L+ CLL • Breyanzi 3L+ iNHL • Reblozyl MF Planned Next 1-2 Years • Sotyktu PsA • Zeposia CD Milestones Already Delivered that De-Risk 2025–2030 and Beyond Zeposia MS Reblozyl 2L TD MDS Breyanzi 3L+ LBCL Abecma 5L+ Zeposia UC Camzyos oHCM Sotyktu PsO Opdualag 1L Mel FDC Breyanzi 2L LBCL Abecma 3-5L Reblozyl 1L MDS Onureg AML maint. New Product Portfolio Significantly De-Risked with Important Catalysts Ahead 6 Camzyos Reblozyl Breyanzi Zeposia Sotyktu Other** 2025 $10B - $13B Risk-Adjusted Sales $25B+ Non-Risk Adjusted* 2030 $4B+ $4B+ $4B+ $4B+ $3B+ $3B+ $1B+ Key Milestones Beyond • Opdualag Adj. Mel • Opdualag 2L+ MSS CRC *Non-risk adjusted revenue potential **Other includes: Abecma, Onureg, Inrebic, and Opdualag Financial projections may contain non promoted sales, BMS promotes only according to label Milestones represent data readouts unless otherwise specified; subject to positive registrational trials and health authority approval
David Elkins Executive Vice President and Chief Financial Officer 7 Q1 2023 Results
Q1 2023 Results Not for Product Promotional Use Strong Total Company Performance 8 Total Company Sales ~$11.3B (3%) YoY, (1%) Ex-FX* $B Q1 Net Sales1 YoY % Ex-FX* % Total Company $11.3 (3%) (1%) In-Line Products $8.6 +4% +6% New Product Portfolio $0.7 ** ** In-Line Products & New Product Portfolio $9.3 +8% +10% Recent LOEs2 $2.0 (34%) (33%) 2Recent LOE Brands = Revlimid & Abraxane $8.6 $9.3 $3.0 $2.0 Q1 2022 Q1 2023 Recent LOEs In-Line & New Products 1Amounts may not add due to rounding **In excess of +100% *See “Forward-Looking Statements and Non-GAAP Financial Information”
Q1 2023 Results Not for Product Promotional Use New Product Portfolio Sales Performance 9 $156 $206 $67 $147 $117 $36 $78 $44 $71 $23 $34 $29 $25 $350 $723 Q1 2022 Q1 2023 Reblozyl Abecma Opdualag Zeposia Breyanzi Onureg Camzyos Inrebic Sotyktu $18 $16 $6 Revenues more than doubled vs prior year $7 $16 +12% or +11% Ex-FX* growth vs prior quarter $199 $206 $125 $147 $104 $117 $79 $78 $55 $71$37 $34 $29 $23 $25$645 $723 Q4 2022 Q1 2023 Reblozyl Abecma Opdualag Zeposia Breyanzi Onureg Camzyos Inrebic Sotyktu $16 *See “Forward-Looking Statements and Non-GAAP Financial Information” $ in millions $ in millions
Q1 2023 Results Not for Product Promotional Use Q1 2023 Solid Tumor Product Summary 10 Opdivo • U.S. growth driven by demand in 1L lung, upper GI indications & adj. bladder cancer • Ex-U.S. growth from 1L lung & upper GI indications Opdualag • 3rd approved I-O agent; potential to be a new SOC in 1L melanoma • U.S. growth driven by strong demand; >20% market share1 in 1L melanoma $M YoY % Ex-FX* % $2,202 +15% +17% $508 (1%) +2% $117 ** ** $239 +12% +14% Q1 Global Net Sales **In excess of +100% 1Source: BMS Internal Analysis *See “Forward-Looking Statements and Non-GAAP Financial Information”
Q1 2023 Results Not for Product Promotional Use As of Dec 31, 20221 As of March 31, 20231 REMS Certified HCPs ~2600 ~3200 Patients in hub ~1800 ~2700 Patients on commercial drug ~900 ~1500 Q1 2023 Cardiovascular Product Summary 11 • U.S. robust underlying demand strength • Ex-U.S. continues to be #1 OAC in key international markets; impacted by some generic entry (UK & Canada) & pricing measures • U.S. increase in total treated & commercial dispensed patients — VALOR: U.S. PDUFA date June 16, 2023 • EU CHMP Positive Opinion in oHCM; approval expected mid-year First-in-class myosin inhibitorBest-in-class & leading OAC within category Q1 Global Net Sales 1Source: BMS Internal Analysis $M YoY % Ex-FX* % $3,423 +7% +8% $M YoY % Ex-FX* % $29 --- --- *See “Forward-Looking Statements and Non-GAAP Financial Information”
Q1 2023 Results Not for Product Promotional Use Q1 2023 Hematology Product Summary 12 Revlimid – Impact from Gx entry; FY 2023 revenue projection of ~$6.5B Pomalyst – Growth driven by demand for triplet-based regimens in earlier lines & favorable buying patterns ex-U.S. Reblozyl • U.S. demand growth & progress in patient adherence • Continued expansion in international markets based on reimbursement timing Abecma - Strong demand supported by increased manufacturing capacity • KarMMa-3: U.S. PDUFA date December 16, 2023; filed in EU & Japan Breyanzi - Strong 2L/3L+ demand supported by increased manufacturing capacity • EU CHMP Positive Opinion in 2L LBCL 1 $M YoY % Ex-FX* % $1,750 (37%) (37%) $832 +1% +2% $429 (11%) (9%) $206 +32% +33% $147 ** ** $71 +61% +66% $34 +48% +52% $25 +39% +39% Q1 Global Net Sales1 **In excess of +100% 1Empliciti grouped in Mature & Other Brands *See “Forward-Looking Statements and Non-GAAP Financial Information”
Q1 2023 Results Not for Product Promotional Use Q1 2023 Immunology Product Summary 13 Zeposia • Growth from demand in MS & expanding contribution from UC • Continued focus on improving formulary access • Expansion in international markets based on reimbursement timing • U.S. continued strong early adoption; significant demand growth in Q1 • Focused on driving demand to enable broader access in 2024 First-in-class selective allosteric TYK2 inhibitor Q1 Global Net Sales % $M YoY % Ex-FX* % $764 (4%) (1%) $78 ** ** % $M YoY % Ex-FX* % $16 --- --- **In excess of +100% As of Dec 31, 20221 As of March 31, 20231 Volume >2000 TRx Equivalent >9500 TRx Equivalent2 Market Share3 ~25-30% Mid-30s% Source of Business • Systemic-naïve (~1/3) • Otezla-experienced (~1/3) • Biologic-experienced (~1/3) Consistent with prior quarter 3Market share of written oral prescriptions in NBRx sourced from BrandImpact 1Source: BMS Internal Analysis *See “Forward-Looking Statements and Non-GAAP Financial Information” 2Cumulative TRx equivalent since launch
Q1 2023 Results Not for Product Promotional Use Q1 2023 Financial Performance 14 US GAAP Non-GAAP $ in billions, except EPS Q1 2023 Q1 2022 Q1 2023 Q1 2022 Total Revenues, net 11.3 11.6 11.3 11.6 Gross Margin % 77.4% 78.8% 77.8% 79.2% Operating Expenses1 4.1 4.1 4.0 4.0 Acquired IPR&D 0.1 0.3 0.1 0.3 Amortization of Acquired Intangibles 2.3 2.4 - - Effective Tax Rate 18.2% 23.9% 15.5% 15.9% Diluted EPS 1.07 0.59 2.05 1.96 Diluted Shares Outstanding (# in millions) 2,113 2,164 2,113 2,164 US P Non- P* Diluted EPS Impact from Acquired IPR&D2 (0.01) (0.10) (0.01) (0.10) 1Operating Expenses = MS&A and R&D 2Comprises the net impact from Acquired IPRD & Licensing income *See “Forward-Looking Statements and Non-GAAP Financial Information”
Q1 2023 Results Not for Product Promotional Use Balanced Approach to Capital Allocation 15*Cash includes cash, cash equivalents and marketable debt securities **Subject to Board approval $B Q1 2023 Total Cash* ~$9.3B Total Debt ~$37.8B • Prioritize opportunities to further diversify portfolio & strengthen long-term outlook • Continued debt reduction ‒ ~$1.6B in debt repayments in Q1 • Maintain strong investment-grade credit rating Business Development Balance Sheet Strength Returning Cash to Shareholders • Continued annual dividend growth** ‒ 14th consecutive dividend increase • Opportunistic share repurchase ‒ ~$7B remaining authorizationStrong operating cash flow generation $3.8 $2.3 $3.7 $3.3 $3.0 Cash flow from Operations $B Q1 2022 Q2 2022 Q3 2022 Q4 2022 Q1 2023
Q1 2023 Results Not for Product Promotional Use February (Prior) April (Revised) April (Affirm) Total Revenues Reported Rates ~2% increase No Change ~2% increase Total Revenues Ex-FX ~2% increase No Change ~2% increase Revlimid ~$6.5 billion No Change ~$6.5 billion Gross Margin % ~77% No Change ~77% Operating Expenses1 Mid-single digit decline No Change Low-single digit decline Tax Rate ~22% ~21% ~17% Diluted EPS $4.03 - $4.33 $4.10 - $4.40 $7.95 - $8.25 2023 Guidance 16 US GAAP* Non-GAAP* 1Operating Expenses = MS&A and R&D, excluding Acquired IPR&D and Amortization of acquired intangibles *See “Forward-Looking Statements and Non-GAAP Financial Information”
17 Giovanni Caforio, MD Chairman of the Board, Chief Executive Officer Chris Boerner, PhD Executive VP, Chief Operating Officer David Elkins Executive VP, Chief Financial Officer Samit Hirawat, MD Executive VP, Chief Medical Officer, Global Drug Development Q1 2023 Results Q&A