On July 27, 2023 Bristol Myers Squibb (NYSE:BMY) reported results for the second quarter of 2023, which reflect continued execution against our strategic priorities (Press release, Bristol-Myers Squibb, JUL 27, 2023, View Source [SID1234633450]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"This was an important quarter for Bristol Myers Squibb," said Giovanni Caforio, M.D., board chair and chief executive officer, Bristol Myers Squibb. "We saw a more rapid than expected decline in Revlimid sales in the quarter, which led to a revision of our financial guidance for the year. Importantly, we continued to advance the renewal and diversification of our portfolio, delivered strong performance across our key in-line products and new product portfolio, while continuing to advance our pipeline. I am confident in our ability to drive future growth and innovation while carrying out our mission to help patients prevail over serious diseases."
Second Quarter
$ amounts in millions, except per share
Change Excl.
amounts
2023
2022
Change
F/X**
Total Revenues
$11,226
$11,887
(6)%
(5)%
Earnings per share – GAAP*
0.99
0.66
50%
N/A
Earnings per share – Non-GAAP* **
1.75
1.93
(9)%
N/A
* GAAP and non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income of ($0.05) in the second quarter of 2023 compared to ($0.14) per share in the second quarter of 2022.
** See "Use of Non-GAAP Financial Information".
SECOND QUARTER FINANCIAL RESULTS
All comparisons are made versus the same period in 2022 unless otherwise stated.
Bristol Myers Squibb posted second quarter revenues of $11.2 billion, a decline of 6%, or 5% when adjusted for foreign exchange, due to lower sales of Revlimid, partially offset by in-line products and our new product portfolio.
U.S. revenues decreased 5% to $7.9 billion in the quarter primarily due to lower sales of Revlimid resulting from generic erosion and an increase in the number of patients receiving free drug product for Revlimid, and to a lesser extent Pomalyst, from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products. This was partially offset by in-line products and our new product portfolio.
International revenues decreased 8% to $3.3 billion in the quarter. When adjusted for foreign exchange impacts, international revenues decreased 6%, primarily due to Revlimid and Eliquis generic erosion and lower average net selling prices, partially offset by Opdivo andour new product portfolio.
On a GAAP basis, gross margin decreased from 77.1% to 74.4% and on a non-GAAP basis, decreased from 78.3% to 75.0% primarily due to product mix.
On a GAAP and non-GAAP basis, marketing, selling and administrative expenses increased 8% and 7%, respectively, to $1.9 billion in the quarter, primarily due to higher costs to support the acceleration of our portfolio, including the launch of new products.
On a GAAP and non-GAAP basis, research and development expenses decreased 3% and 2%, respectively, to $2.3 billion in the quarter.
On a GAAP and non-GAAP basis, Acquired IPRD decreased to $158 million in the quarter from $400 million in the same period a year ago. On a GAAP and non-GAAP basis, licensing income was $20 million in the quarter compared to $16 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, income tax benefit was $218 million despite pre-tax earnings of $1.9 billion primarily due to the receipt of a non-U.S. tax ruling regarding the deductibility of a statutory impairment. On a non-GAAP basis, effective tax rate changed from 17.0% to 16.9%.
The company reported net earnings attributable to Bristol Myers Squibb of $2.1 billion, or GAAP EPS of $0.99, in the second quarter, compared to $1.4 billion, or $0.66 per share, for the same period a year ago. In addition to the items discussed above, the higher GAAP EPS in the second quarter of 2023 also resulted from lower equity investments losses in the second quarter of 2023.
The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $3.7 billion, or non-GAAP EPS of $1.75, in the second quarter, compared to non-GAAP net earnings of $4.2 billion, or non-GAAP EPS of $1.93 per share, for the same period a year ago.
The EPS results in the second quarter of 2023 also include the impact of lower weighted-average common shares outstanding.
SECOND QUARTER PRODUCT REVENUE HIGHLIGHTS
($ amounts in millions)
Quarter Ended June 30,
2023
% Change from Quarter
Ended June 30, 2022
% Change from
Quarter Ended
June 30, 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
$
2,340
$
864
$
3,204
7%
(17)%
(1)%
(17)%
(1)%
Opdivo
1,230
915
2,145
2%
7%
4%
10%
5%
Pomalyst/Imnovid
570
277
847
(7)%
(5)%
(7)%
(4)%
(6)%
Orencia
707
220
927
8%
(1)%
6%
2%
7%
Sprycel
328
130
458
(12)%
(24)%
(16)%
(22)%
(15)%
Yervoy
369
216
585
13%
9%
11%
11%
12%
Mature and other products (a)
197
275
472
2%
(14)%
(8)%
(12)%
(7)%
Total In-Line Products
5,741
2,897
8,638
3%
(7)%
—
(5)%
—
New Product Portfolio
Reblozyl
179
55
234
24%
96%
36%
93%
35%
Abecma
115
17
132
60%
—
48%
—
48%
Opdualag
152
2
154
*
N/A
*
N/A
*
Zeposia
75
25
100
56%
39%
52%
39%
52%
Breyanzi
83
17
100
*
*
*
*
*
Onureg
31
13
44
24%
86%
38%
86%
38%
Inrebic
19
8
27
(5)%
*
17%
*
22%
Camzyos
46
—
46
*
N/A
*
N/A
*
Sotyktu
24
1
25
N/A
N/A
N/A
N/A
N/A
Total New Product Portfolio
724
138
862
80%
75%
79%
75%
79%
Total In-Line and New Product Portfolio
6,465
3,035
9,500
8%
(5)%
4%
(3)%
4%
Recent LOE Products (b)
Revlimid
1,237
231
1,468
(42)%
(38)%
(41)%
(36)%
(41)%
Abraxane
189
69
258
7%
6%
7%
17%
10%
Total Recent LOE Products
1,426
300
1,726
(38)%
(31)%
(37)%
(28)%
(37)%
Total Revenues
$
7,891
$
3,335
$
11,226
(5)%
(8)%
(6)%
(6)%
(5)%
* 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.
SECOND QUARTER PRODUCT REVENUE HIGHLIGHTS
In-Line Products
Revenues for in-line products in the second quarter were $8.6 billion compared to $8.7 billion in the prior year period. In-line products revenue was largely driven by:
Opdivo worldwide revenues increased 4%, or 5% when adjusted for foreign exchange. U.S. revenues increased 2% to $1.2 billion compared to the prior year period. International revenues were $915 million compared to $858 million in the prior year period, representing an increase of 7% primarily due to higher demand as a result of launches for additional indications and core indications, partially offset by foreign exchange impacts and lower average net selling prices. When adjusted for foreign exchange impacts, international revenues increased 10%.
Eliquis worldwide revenues decreased 1% compared to the prior year period. U.S. revenues were $2.3 billion compared to $2.2 billion in the prior year period, representing an increase of 7% primarily due to higher demand, partially offset by GTN adjustments in 2023. International revenues were $864 million compared to $1.0 billion in the prior year period, representing a decrease of 17%, primarily driven by generic erosion in Canada and the U.K. as well as government pricing measures.
New Product Portfolio
New product portfolio worldwide revenues increased to $862 million compared to $482 million in the prior year period representing a growth of 79%, primarily driven by higher demand across the portfolio, including for Opdualag, Reblozyl, Breyanzi, Abecma, Camzyos and Zeposia.
Recent LOE Products
Revlimid worldwide revenues declined by 41% compared to the prior year period, reflecting more rapid decline in revenue in the second quarter of 2023 than expected, due to generic erosion and an increase in the number of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which the company donates products.
SECOND QUARTER PRODUCT AND PIPELINE UPDATE
Cardiovascular
Category
Asset
Milestone
Regulatory
Camzyos
(mavacamten)
The European Commission (EC) approvedCamzyos, the first and only cardiac myosin inhibitor approved in the EU, for the treatment of symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy (HCM) in adult patients. The approval is based upon results from two Phase 3 trials: EXPLORER-HCM and VALOR-HCM.
Camzyos
The U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application to add positive data from the Phase 3 VALOR-HCM trial to the U.S. Prescribing Information for Camzyos. VALOR-HCM is the second Phase 3 trial in which Camzyos demonstrated significant improvement in symptoms of obstructive HCM.
milvexian
The company in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson, was granted Fast Track Designation by the FDA for all three prospective indications for milvexian, an investigational oral factor XIa inhibitor. The designations cover all three indication-seeking studies within the Phase 3 Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all dosing patients.
Oncology
Category
Asset
Milestone
Regulatory
Opdivo
(nivolumab)
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Opdivo as a monotherapy for the adjuvant treatment of adults and adolescents 12 years of age and older with completely resected stage IIB or IIC melanoma. The EC will now review the CHMP recommendation.
Opdivo
The EC approvedOpdivo in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) at a high risk of recurrence in adult patients with tumor cell PD-L1 expression ≥1%. The approval, which makes Opdivo with chemotherapy the first neoadjuvant immunotherapy-based treatment option approved for patients in the European Union in this setting, is based upon results from the Phase 3 CheckMate –816 trial.
repotrectinib
The U.S. FDA accepted the New Drug Application for repotrectinib for the treatment of patients with ROS1-positive locally advanced or metastatic NSCLC. The acceptance was based on results from the Phase 1/2 TRIDENT-1 trial. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 27, 2023.
Clinical &
Research
Opdivo
The Phase 3 CheckMate -7DX trial, evaluating Opdivo in combination with docetaxel in patients with advanced or metastatic castration-resistant prostate cancer (mCRPC), did not meet the primary endpoints of radiographic progressive free survival (rPFS) at final analysis, nor overall survival (OS) at an interim analysis. No safety concerns were reported. Based on the recommendation from the data monitoring committee, BMS has decided to discontinue the study. The study team and the investigators will be unblinded, and patients will be managed according to standards of care as per the discussion between investigators and the patients.
The sub-study of the Phase 3 CheckMate -901 trial met the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review at final analysis. The sub-study results showed that Opdivo in combination with cisplatin-based chemotherapy followed by Opdivo monotherapy demonstrated statistically significant benefits in OS and PFS compared to standard-of-care cisplatin-based combinations as a first-line treatment for patients with unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy.
Opdivo +
Yervoy
Four-year follow-up results from the Phase 3 CheckMate -9LA trial demonstrated durable, long-term survival benefits with Opdivo plus Yervoy with two cycles of chemotherapy compared to four cycles of chemotherapy alone in previously untreated patients with metastatic non-small cell lung cancer.
Hematology
Category
Asset
Milestone
Regulatory
Breyanzi
(lisocabtagene
maraleucel)
The EC approvedBreyanzi for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMLBCL), and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. The approval was based on results from the pivotal Phase 3 TRANSFORM clinical trial.
Reblozyl
(luspatercept-
aamt)
The FDA accepted the supplemental Biologics License Application for Reblozyl, a first-in-class treatment option, to expand its current indication to include treatment of anemia without previous use of erythropoiesis-stimulating agents (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require red blood cell transfusions. The FDA has granted the application Priority Review and assigned a PDUFA goal date of August 28, 2023.
In addition, the European Medicines Agency (EMA) validated the Type II Variation Application for Reblozyl to expand its current indication to include ESA-naïve treatment of anemia in adult patients with very low- to intermediate-risk MDS who may require red blood cell transfusions. The EMA’s validation confirms the submission is complete and begins the start of the EMA’s centralized review process.
The submissions were based on results from the Phase 3 COMMANDS clinical trial.
Japan’s Ministry of Health, Labour and Welfare accepted the New Drug Application for Reblozyl as a treatment of anemia in adult patients with MDS based on the MEDALIST trial, a Japan local Phase 2 trial, and the results of the COMMANDS clinical trial.
Clinical &
Research
Breyanzi
Results from the primary analysis of two studies, TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi in patients with relapsed or refractory follicular lymphoma (FL) in the second-line and third-line plus setting, and the relapsed or refractory mantle cell lymphoma (MCL) cohort of TRANSCEND NHL 001, an open-label, multicenter, pivotal Phase 1, single-arm study evaluating Breyanzi in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including DLBCL, HGBCL, PMBCL, FL3B and MCL, showed deep and durable responses in both relapsed or refractory FL and MCL.
Results from the primary analysis of the pivotal TRANSCEND CLL 004 trial, 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 statistically significant complete response rates in 18.4% of patients in the primary efficacy analysis set. Among patients who achieved a complete response, no disease progression or deaths were observed, with median duration of response not reached.
Reblozyl
First results from the Phase 3 COMMANDS trial, an open-label, randomized trial evaluating Reblozyl versus epoetin alfa, an erythropoiesis-stimulating agent, for the treatment of anemia in adult patients with very low-, low- or intermediate-risk MDS who require red blood cell transfusions and are ESA-naïve demonstrated how nearly twice as many patients treated with Reblozyl achieved superior transfusion independence with concurrent hemoglobin increase versus epoetin alfa, as well as a durable response rate.
Immunology
Category
Asset
Milestone
Clinical &
Research
LPA1
antagonist
BMS-986278
Results from the Phase 2 study evaluating BMS-986278, a potential first-in-class oral, lysophosphatidic acid receptor 1 (LPA1)antagonist in patients with idiopathic pulmonary fibrosis, showed 26 weeks of treatment with twice-daily 60mg dose reduced the rate of lung function decline. Data demonstrate the potential of BMS-986278 in pulmonary fibrosis and support progression into Phase 3.
First Half
$ amounts in millions, except per share
Change Excl.
amounts
2023
2022
Change
F/X**
Total Revenues
$22,563
$23,535
(4)%
(3)%
Earnings per share – GAAP*
2.06
1.25
65%
N/A
Earnings per share – Non-GAAP* **
3.80
3.89
(2)%
N/A
* GAAP and non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income of ($0.06) in the first half 2023 compared to ($0.24) per share in the first half 2022.
** See "Use of Non-GAAP Financial Information".
FIRST HALF FINANCIAL RESULTS
All comparisons are made versus the same period in 2022 unless otherwise stated.
Bristol Myers Squibb posted first half revenues of $22.6 billion, a decline of 4%, or 3% when adjusted for foreign exchange, primarily due to lower revenue for Revlimid.
U.S. revenues remained consistent at $15.9 billion in the first half, primarily due to lower sales of Revlimid resulting from generic erosion and an increase in the number of patients receiving free drug product for Revlimid, and to a lesser extent, Pomalyst, from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products. This was offset by in-line products and our new product portfolio.
International revenues decreased 12% to $6.6 billion in the first half. When adjusted for foreign exchange impacts, international revenues decreased 9%, primarily due to Revlimid and Eliquis generic erosion and lower average net selling prices, partially offset by Opdivo and our new product portfolio.
On a GAAP basis, gross margin decreased from 77.9% to 75.9% and on a non-GAAP basis, decreased from 78.8% to 76.4%, primarily due to product mix.
On a GAAP and non-GAAP basis, marketing, selling and administrative expenses increased 2% to $3.7 billion in the first half, primarily due to higher costs to support the acceleration of our portfolio, including the launch of new products.
On a GAAP basis, research and development expenses remained consistent at $4.6 billion and on a non-GAAP basis increased 1% to $4.5 billion.
On a GAAP and non-GAAP basis, Acquired IPRD decreased to $233 million in the first half of 2023 from $733 million in the same period a year ago. On a GAAP and non-GAAP basis, licensing income was $63 million in the first half of 2023 compared to $68 million in the same period a year ago.
On a GAAP basis, amortization of acquired intangible assets decreased 7% to $4.5 billion in the first half, primarily due to the Abraxane marketed product right being fully amortized in the fourth quarter of 2022.
The GAAP effective tax rate decreased from 25.6% to 6.2%, primarily due to the receipt of a non-U.S. tax ruling regarding the deductibility of a statutory impairment. On a non-GAAP basis, effective tax rate decreased from 16.4% to 16.2%.
The company reported net earnings attributable to Bristol Myers Squibb of $4.3 billion, or GAAP EPS of $2.06, in the first half, compared to $2.7 billion, or $1.25 per share, for the same period a year ago. In addition to the items discussed above, the higher GAAP EPS in the first half of 2023 also resulted from 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 $8.0 billion, or non-GAAP EPS of $3.80, in the first half, compared to non-GAAP net earnings of $8.4 billion, or non-GAAP EPS of $3.89 per share, for the same period a year ago.
The EPS results in the first half of 2023 also include the impact of lower weighted-average common shares outstanding.
FIRST HALF PRODUCT REVENUE HIGHLIGHTS
($ amounts in millions)
Six Months Ended June 30,
2023
% Change from Six Months
Ended June 30, 2022
% Change from Six
Months Ended
June 30, 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
$
4,894
$
1,733
$
6,627
13%
(18)%
3%
(15)%
4%
Opdivo
2,520
1,827
4,347
9%
9%
9%
14%
11%
Pomalyst/Imnovid
1,115
564
1,679
(5)%
1%
(3)%
4%
(2)%
Orencia
1,269
422
1,691
2%
—
1%
6%
3%
Sprycel
623
264
887
(8)%
(25)%
(14)%
(20)%
(12)%
Yervoy
683
410
1,093
7%
2%
5%
7%
7%
Mature and other products (a)
379
560
939
1%
(17)%
(10)%
(14)%
(8)%
Total In-Line Products
11,483
5,780
17,263
7%
(7)%
2%
(3)%
3%
New Product Portfolio
Reblozyl
337
103
440
21%
*
34%
*
34%
Abecma
233
46
279
82%
64%
79%
68%
79%
Opdualag
268
3
271
*
N/A
*
N/A
*
Zeposia
127
51
178
84%
55%
75%
58%
75%
Breyanzi
141
30
171
91%
*
*
*
*
Onureg
56
22
78
27%
100%
42%
*
44%
Inrebic
36
16
52
3%
*
27%
*
29%
Camzyos
75
—
75
*
N/A
*
N/A
*
Sotyktu
39
2
41
N/A
N/A
N/A
N/A
N/A
Total New Product Portfolio
1,312
273
1,585
89%
99%
91%
*
91%
Total In-Line and New Product Portfolio
12,795
6,053
18,848
12%
(4)%
6%
(1)%
7%
Recent LOE Products (b)
Revlimid
2,778
440
3,218
(33)%
(61)%
(39)%
(59)%
(39)%
Abraxane
351
146
497
1%
38%
9%
50%
12%
Total Recent LOE Products
3,129
586
3,715
(31)%
(53)%
(35)%
(50)%
(35)%
Total Revenues
$
15,924
$
6,639
$
22,563
—
(12)%
(4)%
(9)%
(3)%
* 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 HALF PRODUCT REVENUE HIGHLIGHTS
In-Line Products
Revenues for in-line products in the first half were $17.3 billion compared to $17.0 billion in the prior year period. In-line products revenue was largely driven by:
Opdivo worldwide revenues increased 9%, or 11% when adjusted for foreign exchange. U.S. revenues were $2.5 billion compared to $2.3 billion in the prior year period, representing an increase of 9% 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, and various gastric cancers, and adjuvant bladder cancer. International revenues were $1.8 billion compared to $1.7 billion in the prior year period, representing an increase of 9% primarily due to higher demand as a result of launches for additional indications and core indications, partially offset by foreign exchange impacts and lower average net selling prices. When adjusted for foreign exchange impacts, international revenues increased 14%.
Eliquis worldwide revenues increased 3% compared to the prior year period. U.S. revenues were $4.9 billion compared to $4.3 billion in the prior year period, representing an increase of 13% primarily due to higher demand. International revenues were $1.7 billion compared to $2.1 billion in the prior year period, representing a decrease of 18%, primarily driven by generic erosion in the U.K. and Canada. When adjusted for foreign exchange impacts, international revenues decreased 15%.
New Product Portfolio
New product portfolio worldwide revenues increased to $1.6 billion compared to $832 million in the prior year period representing a growth of 91%, primarily driven by higher demand across the portfolio, including Opdualag, Abecma, Reblozyl, Breyanzi, Zeposia and Camzyos.
Recent LOE Products
Revlimid worldwide revenues declined by 39% compared to the prior year period, reflecting more rapid decline in revenue in the second quarter of 2023 than expected, due to generic erosion and an increase in the number of patients receiving free drug product from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which the company donates products.
Environmental, Social & Governance (ESG)
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.
Capital Allocation
The company maintains a balanced approach to capital allocation focused on prioritizing investment for growth through business development, reducing debt, growing the dividend and opportunistic share repurchases. Dividend decisions are subject to Board of Directors approval.
Today, the company is announcing a $4 billion accelerated share repurchase program, which is expected to be executed during the third quarter of 2023.
Financial Guidance
Bristol Myers Squibb is revising its 2023 guidance as follows:
Adjusting outlook for total revenues and GAAP and non-GAAP EPS primarily due to lower than expected sales of Revlimid, and to a lesser extent, Pomalyst.
Revenues from Revlimid are now expected to be approximately $5.5 billion.
GAAP EPS guidance also reflects higher tax benefits resulting from a non-U.S. tax ruling.
Key 2023 GAAP and non-GAAP line-item guidance assumptions are:
U.S. GAAP
Non-GAAP2
April
(Prior)
July
(Revised)
April
(Prior)
July
(Revised)
Total Revenues
(as reported)
~2% increase
Low single-digit decline
~2% increase
Low single-digit decline
Total Revenues
(excl. F/X)
~2% increase
Low single-digit decline
~2% increase
Low single-digit decline
Revlimid
~$6.5 billion
~$5.5 billion
~$6.5 billion
~$5.5 billion
Gross Margin %
~77%
~76%
~77%
~76%
Operating Expenses1
Mid single-digit decline
Low single-digit decline
Low single-digit decline
Low single-digit decline
(No change)
Tax Rate
~21%
~16%
~17%
~17.5%
Diluted EPS
$4.10-$4.40
$3.72-$4.02
$7.95-$8.25
$7.35-$7.65
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 the 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.
Reaffirms 2020-2025 Financial Targets
The company is reaffirming its previously communicated 2020-2025 targets:
Expects low- to mid single-digit revenue CAGR at constant exchange rates.
Expects low double-digit revenue CAGR for our in-line and new product portfolio at constant exchange rates, with $8-$10 billion growth from in-line brands and $10-$13 billion in 2025 from our new product portfolio.
Expects to maintain at least 40% non-GAAP operating margin.
This financial guidance excludes the impact of any potential future strategic acquisitions and divestitures, as well as any specified items as discussed under "Use of Non-GAAP Financial Information." There are no reliable or reasonably estimable comparable GAAP measures for the non-GAAP financial guidance contained herein. See "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, July 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 View Source." target="_blank" title="View Source." rel="nofollow">View Source
Investors and the public can access the live conference call by registering in advance here. Those unable to register can access the live conference call by dialing in the U.S. toll free 1-866-777-2509 or international +1 412-317-5413. Materials related to the call will be available at View Source prior to the start of the conference call.
A replay of the webcast will be available at View Source 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 July 27 through 11:30 a.m. ET on August 10, 2023, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, confirmation code: 7900147.