On April 25, 2024 Bristol Myers Squibb (NYSE: BMY) reported results for the first quarter of 2024, which reflect meaningful progress in the company’s growth portfolio and pipeline (Press release, Bristol-Myers Squibb, APR 25, 2024, View Source [SID1234642339]).
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"We had a good start to 2024, with revenue growth, important advances in our pipeline and the closure of several strategically important transactions," said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. "Our focus remains on strengthening the company’s long-term growth profile. As a part of our continued evolution, we’re executing a strategic productivity initiative that will allow us to be more agile, drive efficiency across the company, and prioritize investing in opportunities where we see the greatest potential to get the most promising medicines to patients as quickly as possible."
First Quarter
$ in millions, except per share amounts
2024
2023
Change
Change Excl.
F/X**
Total Revenues
$11,865
$11,337
5%
6%
(Loss)/Earnings Per Share — GAAP*
(5.89)
1.07
N/A
N/A
(Loss)/Earnings Per Share — Non-GAAP* **
(4.40)
2.05
N/A
N/A
Acquired IPRD charge and Licensing Income Net Impact on Earnings Per Share
(6.30)
(0.01)
N/A
N/A
* GAAP and Non-GAAP loss per share include the net impact of Acquired IPRD charges and licensing income primarily driven by the Karuna Therapeutics asset acquisition and SystImmune collaboration.
** See "Use of Non-GAAP Financial Information".
FIRST QUARTER RESULTS
All comparisons are made versus the same period in 2023 unless otherwise stated.
Bristol Myers Squibb posted first quarter revenues of $11.9 billion, an increase of 5% or 6% when adjusted for foreign exchange impacts, primarily driven by Eliquis, Reblozyl and Opdualag, partially offset by Opdivo and Revlimid.
U.S. revenues increased 7% to $8.5 billion primarily due to Eliquis, Reblozyl and Opdualag, partially offset by Revlimid. Opdivo revenues were $1.2 billion compared to $1.3 billion, representing a decrease of 10% primarily due to inventory and the timing of orders, partially offset by demand growth.
International revenues remained relatively flat at $3.4 billion primarily due to lower average net selling prices, offset in part by higher demand for Opdivo, Yervoy and Reblozyl. The negative impact from foreign exchange was 5%.
On a GAAP basis, gross margin decreased from 77.4% to 75.3%, and on a non-GAAP basis, gross margin decreased from 77.8% to 75.5%, primarily due to product mix.
On a GAAP basis, marketing, selling and administrative expenses increased 34% to $2.4 billion, and on a non-GAAP basis, increased 13% to $2.0 billion, primarily due to the timing of spend and the impact of recent acquisitions.
On a GAAP basis, research and development expenses increased 16% to $2.7 billion, and on a non-GAAP basis, increased 6% to $2.3 billion, primarily due to the impact of recent acquisitions and higher costs to support the overall portfolio.
On a GAAP and non-GAAP basis, Acquired IPRD increased to $12.9 billion from $75 million, primarily due to the Karuna asset acquisition and SystImmune collaboration. On a GAAP and non-GAAP basis, licensing income was $12 million compared to $43 million during the same period a year ago.
On a GAAP basis, amortization of acquired intangible assets increased 4% to $2.4 billion, primarily due to the Mirati Therapeutics and RayzeBio acquisitions and approval of Augtyro in the fourth quarter of 2023.
On a GAAP basis, income tax expense was $392 million on a pre-tax loss of $11.5 billion, and on a non-GAAP basis, income tax expense was $732 million on a pre-tax loss of $8.2 billion, primarily due to the $12.1 billion one-time, non-tax-deductible charge for the acquisition of Karuna.
On a GAAP basis, the company reported net loss attributable to Bristol Myers Squibb of $11.9 billion, or ($5.89) per share, during the first quarter of 2024 compared to net earnings of $2.3 billion, or $1.07 per share, for the same period a year ago. In addition to the items above, the decrease was also due to lower litigation and other settlement income. The company reported on a non-GAAP basis net loss attributable to Bristol Myers Squibb of $8.9 billion, or ($4.40) per share, during the first quarter of 2024 compared to net earnings of $4.3 billion, or $2.05 per share, for the same period a year ago. In addition to the items above, the decrease was also due to higher interest expense resulting from new debt issuance to fund recent acquisitions.
FIRST QUARTER PRODUCT REVENUE HIGHLIGHTS
($ amounts in millions)
Quarter Ended March 31,
2024
% Change from Quarter
Ended March 31, 2023
% Change from
Quarter Ended
March 31, 2023
Ex-F/X**
U.S.
Int’l (c)
WW(d)
U.S.
Int’l(c)
WW(d)
Int’l(c)
WW(d)
Growth Portfolio
Opdivo
$
1,155
$
923
$
2,078
(10)%
—%
(6)%
9%
(2)%
Orencia
572
226
798
4%
6%
4%
13%
6%
Yervoy
368
215
583
18%
10%
15%
17%
18%
Reblozyl
293
61
354
88%
22%
72%
22%
72%
Opdualag
198
8
206
71%
*
76%
*
76%
Abecma
52
30
82
(56)%
3%
(44)%
7%
(44)%
Zeposia
72
38
110
41%
41%
41%
41%
41%
Breyanzi
87
20
107
50%
54%
51%
54%
51%
Camzyos
77
7
84
*
N/A
*
N/A
*
Sotyktu
34
10
44
*
*
*
*
*
Augtyro
6
—
6
N/A
N/A
N/A
N/A
N/A
Krazati
21
—
21
N/A
N/A
N/A
N/A
N/A
Other Growth Products(a)
148
171
319
3%
26%
14%
30%
16%
Total Growth Portfolio
3,083
1,709
4,792
9%
8%
8%
15%
11%
Legacy Portfolio
Eliquis
2,821
899
3,720
12%
—%
9%
1%
9%
Revlimid
1,453
216
1,669
(5)%
(5)%
(5)%
(1)%
(4)%
Pomalyst/Imnovid
597
268
865
10%
(8)%
4%
(7)%
4%
Sprycel
282
92
374
(2)%
(34)%
(13)%
(30)%
(11)%
Abraxane
145
72
217
(10)%
(8)%
(9)%
10%
(3)%
Other Legacy Products (b)
95
133
228
19%
(20)%
(7)%
(17)%
(6)%
Total Legacy Portfolio
5,393
1,680
7,073
5%
(7)%
2%
(4)%
3%
Total Revenues
$
8,476
$
3,389
$
11,865
7%
—%
5%
5%
6%
*
In excess of +100%
**
See "Use of Non-GAAP Financial Information".
(a)
Includes Nulojix, Onureg, Inrebic, Empliciti and royalty revenue.
(b)
Includes other mature brands.
(c)
Beginning in 2024, Puerto Rico revenues are included in International revenues. Prior period amounts have been reclassified to conform to the current presentation.
(d)
Worldwide (WW) includes U.S. and International (Int’l).
FIRST QUARTER PRODUCT REVENUE HIGHLIGHTS
Growth Portfolio
Growth Portfolio worldwide revenues increased to $4.8 billion compared to $4.4 billion in the prior year period, representing growth of 8%, or 11% when adjusted for foreign exchange impacts. Growth Portfolio revenues were primarily driven by higher demand for Reblozyl, Opdualag, Yervoy, Camzyos, and Sotyktu, partially offset by Opdivo and Abecma.
Legacy Portfolio
Revenues for the Legacy Portfolio in the first quarter were $7.1 billion compared to $6.9 billion in the prior year period. Legacy Portfolio revenues were largely driven by a 9% increase in Eliquis worldwide revenues on a reported basis and when adjusted for foreign exchange impacts, partially offset by a decline in Revlimid worldwide revenues of 5%, or 4% when adjusted for foreign exchange impacts.
PRODUCT AND PIPELINE UPDATE
Cardiovascular
Category
Asset
Milestone
Clinical & Research
Camzyos
(mavacamten)
An analysis of results from the 10-month post-launch evaluation of the Camzyos REMS Program in 1,524 patients demonstrated that approximately 1% of patients reported clinical heart failure requiring hospitalization and 2.8% of patients reported a decrease in left ventricular ejection fraction to <50%.
Oncology
Category
Asset
Milestone
Regulatory
Opdivo
(nivolumab)
The U.S. Food and Drug Administration (FDA) approved Opdivo, in combination with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC). The approval is based on results from the Phase 3 CheckMate -901 trial evaluating Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy, compared to cisplatin-gemcitabine alone, for patients with previously untreated unresectable or metastatic UC.
Krazati
(adagrasib)
The FDA accepted the supplemental New Drug Application (sNDA) for Krazati in combination with cetuximab for the treatment of patients with previously treated KRASG12C -mutated locally advanced or metastatic colorectal cancer. The acceptance was based on the results of the Phase 1/2 KRYSTAL-1 trial. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024.
AugtyroTM
(repotrectinib)
The FDA accepted the sNDA for Augtyro for the treatment of adult and pediatric patients 12 years of age and older with NTRK-positive locally advanced or metastatic solid tumors. The acceptance is based on results from the registrational Phase 1/2 TRIDENT-1 trial and the CARE study. The FDA granted the application Priority Review and assigned a PDUFA goal date of June 15, 2024.
Opdivo
The FDA accepted the supplemental Biologics Application (sBLA) for neoadjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The FDA assigned a PDUFA goal date of October 8, 2024.
In addition, the European Medicines Agency (EMA) validated the type II variation application for neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo for the perioperative treatment of resectable stage IIA to IIIB NSCLC. Application validation confirms the submission is complete and begins the EMA’s centralized review procedure.
The FDA’s sBLA acceptance and the EMA’s application validation are based on results from the Phase 3 CheckMate -77T trial.
Clinical & Research
Krazati
The pivotal Phase 3 KRYSTAL-12 study, evaluating Krazati as a monotherapy in patients with pretreated locally advanced or metastatic NSCLC harboring a KRASG12C mutation, met the primary endpoint of progression-free survival (PFS) and the key secondary endpoint of overall response rate as assessed by Blinded Independent Central Review at final analysis for these endpoints. The study remains ongoing to assess the additional key secondary endpoint of overall survival.
Krazati
Data from the cohorts of the Phase 1/2 KRYSTAL-1 study evaluating Krazati in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer demonstrated clinically meaningful activity. With a median follow up of 11.9 months in 94 patients, Krazati plus cetuximab demonstrated an objective response rate of 34%, median PFS of 6.9 months, and median overall survival of 15.9 months in pre-treated patients.
OpdualagTM
(nivolumab and relatlimab)
Initial data from a randomized Phase 2 study evaluating Opdualag in NSCLC support the initiation of a Phase 3 trial in 2024 evaluating Opdualag plus chemotherapy versus PD-1/PD-L1 plus chemotherapy in an important segment of the disease. Phase 2 data is expected to be disclosed later this year.
Opdivo+Yervoy
The Phase 3 CheckMate -9DW trial evaluating Opdivo plus Yervoy as a first-line treatment for patients with advanced hepatocellular carcinoma who have not received a prior systemic therapy met its primary endpoint of improved overall survival compared to investigator’s choice of sorafenib or lenvatinib at a pre-specified interim analysis.
Hematology
Category
Asset
Milestone
Regulatory
Abecma
(idecabtagene vicleucel)
The European Commission (EC) approved Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. The approval is based on results from the Phase 3 KarMMa-3 trial. Abecma is the first CAR T cell immunotherapy approved in the European Union for use in earlier lines of therapy for relapsed and refractory multiple myeloma.
Abecma
The FDA approved Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The approval is based on results from the Phase 3 KarMMa-3 trial.
Abecma is being jointly developed and commercialized in the U.S. by Bristol Myers Squibb and 2seventy bio, Inc.
Breyanzi
(lisocabtagene maraleucel)
The FDA granted accelerated approval of Breyanzi for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor. The accelerated approval is based on the Phase 1/2 open-label, single-arm TRANSCEND CLL 004 trial.
Reblozyl
(luspatercept-aamt)
The EC expanded approval of Reblozyl to include the first-line treatment of adult patients with transfusion-dependent anemia due to very low, low and intermediate-risk myelodysplastic syndromes. The approval covers all European Union member states and is based on the pivotal Phase 3 COMMANDS trial.
Immunology
Category
Asset
Milestone
Clinical & Research
Zeposia
(ozanimod)
First of two induction Phase 3 YELLOWSTONE trials evaluating Zeposia in adult patients with moderate-to-severe active Crohn’s disease did not meet its primary endpoint of clinical remission at Week 12. The safety profile of Zeposia in this study was consistent with that observed in previously reported trials.
Zeposia
Data from the Phase 3 DAYBREAK open-label extension trial demonstrated the long-term efficacy and safety profile of Zeposia in patients with relapsing forms of multiple sclerosis. In the DAYBREAK long-term extension study, treatment with Zeposia demonstrated a low annualized relapse rate of 0.098 and 67% of patients were relapse-free at six years. An analysis of DAYBREAK data showed nearly 97% of followed patients were relapse-free at 90 days post Zeposia discontinuation. Patients that did relapse showed no evidence of rebound effect.
Neuroscience
Category
Asset
Milestone
Clinical & Research
KarXT (xanomeline-trospium)
Interim long-term efficacy data from the Phase 3 EMERGENT-4 open-label extension trial demonstrated that KarXT was associated with significant improvement in symptoms of schizophrenia across all efficacy measures at 52 weeks.
In addition, pooled interim long-term safety, tolerability and metabolic outcomes data from the Phase 3 EMERGENT-4 and EMERGENT-5 trials evaluating the safety, tolerability and efficacy of KarXT in adults with schizophrenia showed that KarXT demonstrated a favorable weight and long-term metabolic profile where most patients experience stability or improvements on key metabolic parameters over 52 weeks of treatment. KarXT was generally well-tolerated, with a side effect profile consistent with prior trials of KarXT in schizophrenia.
Business Development
The company recently completed multiple transactions, strengthening its long-term growth profile and enhancing its portfolio and pipeline.
With the acquisition of Karuna Therapeutics, Inc., Bristol Myers Squibb expanded its position in neuroscience and added important assets, including KarXT, an antipsychotic with a novel mechanism of action and differentiated efficacy and safety. KarXT has a PDUFA goal date of September 26, 2024, for the treatment of schizophrenia in adults.
By acquiring RayzeBio, Inc., a clinical-stage radiopharmaceutical therapeutics company with a differentiated platform and state-of-the-art manufacturing capabilities, Bristol Myers Squibb further diversified its oncology portfolio and gained a rich pipeline of potentially first-in-class and best-in-class drug development programs currently targeting solid tumors.
Through the acquisition of Mirati Therapeutics, Inc., Bristol Myers Squibb strengthened its pipeline and added commercialized lung cancer medicine Krazati to its oncology portfolio, as well as several promising clinical assets.
The company completed an exclusive license and collaboration agreement with SystImmune to develop and commercialize a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate with the potential to treat a variety of solid tumors, including lung and breast cancer.
On April 22, Bristol Myers Squibb and Cellares announced a worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies. As a part of the agreement, Cellares will optimize, automate, and tech-transfer select Bristol Myers Squibb CAR T cell therapies onto its automated and high-throughput manufacturing platform, the Cell ShuttleTM. This agreement enables Bristol Myers Squibb to expand its manufacturing capacity, meeting the growing demand for its diverse range of cell therapies through a platform that is scalable and has the potential to improve turnaround time, bringing the promise of cell therapies to more patients faster.
Strategically Enhancing Productivity and Efficiency
Bristol Myers Squibb is executing a strategic productivity initiative that will drive approximately $1.5 billion in cost savings by the end of 2025, the majority of which will be reinvested to fund innovation and drive growth.
As a part of this initiative, the company is:
Focusing resources on R&D programs with the potential to deliver the greatest return on investment;
Prioritizing investing in key growth brands; and
Optimizing operations across the organization.
Company executives will provide additional details on these actions during the company’s first quarter 2024 earnings conference call.
Financial Guidance
As previously communicated, Bristol Myers Squibb is updating portions of its 2024 line-item guidance, including Non-GAAP EPS, to reflect the impact of recent transactions.
Non-GAAP EPS was updated to account for the following:
2024 Non-GAAP EPS Guidance
February Diluted EPS (Prior)
$7.10 – $7.40
Acquired IPRD Impact1
($6.30)
Dilution Impact (RayzeBio)
($0.13)
Dilution Impact (Karuna Therapeutics)
($0.30)
Total Deals Impact
($6.73)
Revised Diluted EPS
$0.40 – $0.70
1 Primarily represents the Acquired IPRD impact from the Karuna Therapeutics asset acquisition and SystImmune collaboration.
Non-GAAP other income/(expense) was updated primarily due to the financing of the recent acquisitions.
Non-GAAP tax rate was updated to approximately 69% to reflect the impact of a $12.1 billion one-time, non-tax-deductible IPRD charge from the Karuna Therapeutics acquisition, which is expected to contribute 51% to the full-year tax rate.
2024 line-item guidance updates are:
Non-GAAP2
February
(Prior)
April
(Revised)
Total Revenues
Low single-digit increase
No Change
Total Revenues
(excl. F/X)
Low single-digit increase
No Change
Gross Margin %
~74%
No Change
Operating Expenses1
Low single-digit increase
No Change
Other income/(expense)
~$250M
~($250M)
Effective tax rate
~17.5%
~69%
Diluted EPS
$7.10 – $7.40
$0.40 – $0.70
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 2024 financial guidance excludes the impact of any potential future strategic acquisitions, divestitures, 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. Non-GAAP guidance assumes current exchange rates. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.
A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures 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 without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. 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. See "Cautionary Statement Regarding Forward-Looking Statements" and "Use of Non-GAAP Financial Information."
Environmental, Social & Governance (ESG)
As a leading biopharmaceutical company, Bristol Myers Squibb’s passion for making an impact extends beyond the discovery, development and delivery of innovative medicines that help patients prevail over serious diseases.
On April 2, 2024, the company published its latest ESG report, which details the company’s meaningful progress, its evolved ESG strategy, and its long-term aspirational ESG goals. The company’s evolved approach further integrates its ESG strategy and its business strategy. The ESG strategy focuses on three core pillars: advancing patient health around the world, expanding the boundaries of science, and fostering a high-performing and inclusive global workforce.
Highlights from the report include:
Advancing tailored access programs in low-and middle-income countries;
Making clinical trials more accessible to underrepresented groups and ensuring research efforts better reflect patient populations;
Sustained workforce representation and increased community engagement by the company’s employees;
Advancing climate action goals and increasing the company’s renewable energy footprint; and
Incorporating new ESG metrics into the executive compensation program and advancing data privacy and cybersecurity efforts.
Conference Call Information
Bristol Myers Squibb will host a conference call today, Thursday, April 25, 2024, at 8:00 a.m. ET during which company executives will review 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 register for the live conference call here. Those unable to register can access the live conference call by dialing in the U.S. toll-free 1-833-816-1116 or international +1 412-317-0705. 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 April 25, 2024, through 11:30 a.m. ET on May 9, 2024, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, confirmation code: 5034750.