On July 26, 2024 Bristol Myers Squibb (NYSE: BMY) reported results for the second quarter of 2024 (Press release, Bristol-Myers Squibb, JUL 26, 2024, View Source [SID1234645106]).
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"Our second quarter results reflect progress against our strategy to position BMS for long-term, sustainable growth," said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. "As we move into the second half of the year, we remain focused on prioritizing opportunities with the greatest growth potential and impact for patients, including the anticipated U.S. launch of KarXT. We’re also driving operational excellence throughout the company, becoming more agile and strengthening execution."
Second Quarter
$ in millions, except per share amounts
2024
2023
Change
Change Excl.
F/X**
Total Revenues
$12,201
$11,226
9%
11%
Earnings Per Share — GAAP*
0.83
0.99
(16)%
N/A
Earnings Per Share — Non-GAAP* **
2.07
1.75
18%
N/A
Acquired IPRD charge and Licensing Income Net Impact on Earnings Per Share
(0.04
)
(0.05
)
N/A
N/A
* GAAP and Non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income.
** See "Use of Non-GAAP Financial Information".
SECOND QUARTER RESULTS
All comparisons are made versus the same period in 2023 unless otherwise stated.
Bristol Myers Squibb posted second quarter revenues of $12.2 billion, an increase of 9%, or 11% when adjusted for foreign exchange impacts, primarily driven by the Growth Portfolio and Eliquis .
U.S. revenues increased 13% to $8.8 billion, primarily due to the Growth and Legacy Portfolios.
International revenues decreased 1% to $3.4 billion, primarily due to the negative impact from foreign exchange of 7% and Revlimid, partially offset by Opdivo.
On a GAAP basis, gross margin decreased from 74.4% to 73.2%, primarily due to a one-time impairment charge related to marketed product rights. On a non-GAAP basis, gross margin increased from 75.0% to 75.6% due to product mix.
On a GAAP and non-GAAP basis, marketing, selling and administrative expenses remained relatively flat at $1.9 billion.
On a GAAP basis, research and development expenses increased 28% to $2.9 billion, primarily due to an IPRD impairment charge resulting from the decision to discontinue further development of alnuctamab. On a non-GAAP basis, research and development expenses remained relatively flat at $2.3 billion.
On a GAAP and non-GAAP basis, Acquired IPRD decreased to $132 million from $158 million. On a GAAP and non-GAAP basis, licensing income was $37 million compared to $20 million.
On a GAAP basis, amortization of acquired intangible assets increased 7% to $2.4 billion, primarily due to the RayzeBio acquisition in 2024 and approval of Augtyro in the fourth quarter of 2023.
On a GAAP basis, income tax benefit was $398 million despite pre-tax earnings of $1.3 billion, primarily due to the release of income tax reserves. On a non-GAAP basis, effective tax rate changed from 16.9% to 14.1%, primarily due to the release of income tax reserves.
On a GAAP basis, the company reported net income attributable to Bristol Myers Squibb of $1.7 billion, or $0.83 per share, during the second quarter of 2024 compared to $2.1 billion, or $0.99 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. The company reported non-GAAP net earnings attributable to Bristol Myers Squibb of $4.2 billion, or $2.07 per share, during the second quarter of 2024 compared to $3.7 billion, or $1.75 per share, for the same period a year ago.
SECOND QUARTER PRODUCT REVENUE HIGHLIGHTS
($ amounts in millions)
Quarter Ended June 30,
2024
% Change from Quarter
Ended June 30, 2023
% Change from
Quarter Ended
June 30, 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
$
1,406
$
981
$
2,387
15%
6%
11%
18%
16%
Orencia
742
206
948
7%
(11)%
2%
(2)%
5%
Yervoy
404
226
630
10%
4%
8%
11%
10%
Reblozyl
348
77
425
96%
38%
82%
41%
82%
Opdualag
223
12
235
48%
*
53%
*
53%
Abecma
54
41
95
(53)%
*
(28)%
*
(27)%
Zeposia
111
40
151
52%
48%
51%
48%
51%
Breyanzi
122
31
153
47%
82%
53%
94%
55%
Camzyos
130
9
139
*
N/A
*
N/A
*
Sotyktu
41
12
53
71%
*
*
*
*
Augtyro
7
—
7
N/A
N/A
N/A
N/A
N/A
Krazati
29
3
32
N/A
N/A
N/A
N/A
N/A
Other Growth Products(a)
168
173
341
4%
30%
16%
35%
18%
Total Growth Portfolio
3,785
1,811
5,596
21%
11%
18%
21 %
21%
Legacy Portfolio
Eliquis
2,544
872
3,416
10%
(2)%
7%
—%
7%
Revlimid
1,165
188
1,353
(4)%
(24)%
(8)%
(20)%
(7)%
Pomalyst/Imnovid
716
243
959
27%
(14)%
13%
(11)%
14%
Sprycel
341
83
424
6%
(39)%
(7)%
(34)%
(6)%
Abraxane
154
77
231
(18)%
8%
(10)%
25%
(6)%
Other Legacy Products(b)
96
126
222
16%
(24)%
(10)%
(19)%
(8)%
Total Legacy Portfolio
5,016
1,589
6,605
7%
(11)%
2%
(8)%
3%
Total Revenues
$
8,801
$
3,400
$
12,201
13%
(1)%
9%
6%
11%
*
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).
SECOND QUARTER PRODUCT REVENUE HIGHLIGHTS
Growth Portfolio
Growth Portfolio worldwide revenues increased to $5.6 billion compared to $4.7 billion in the prior year period, representing growth of 18% on a reported basis, or 21% when adjusted for foreign exchange impacts. Growth Portfolio revenues were primarily driven by higher demand for Opdivo, Reblozyl, Camzyos and Opdualag, partially offset by Abecma.
Legacy Portfolio
Revenues for the Legacy Portfolio in the second quarter were $6.6 billion compared to $6.5 billion in the prior year period, representing growth of 2% on a reported basis, or 3% when adjusted for foreign exchange impacts. Legacy Portfolio revenues were driven by higher demand for Eliquis and Pomalyst, partially offset by a decline in Revlimid due to generic erosion.
PRODUCT AND PIPELINE UPDATE
Bristol Myers Squibb recently achieved several important clinical and regulatory milestones.
Today, the company is announcing that the Phase 3 trial evaluating the efficacy and safety of cendakimab in patients with eosinophilic esophagitis (EoE) met both co-primary endpoints. The company will work with key investigators to present detailed results at an upcoming medical conference.
Multiple regulatory approvals were received during the second quarter, including U.S. Food and Drug Administration (FDA) approval for Breyanzi to expand into follicular lymphoma and mantle cell lymphoma. In addition, the FDA and the European Medicines Agency (EMA) are each currently evaluating an application from the company for the approval of subcutaneous nivolumab.
Oncology
Category
Asset
Milestone
Regulatory
Opdivo
(nivolumab) +
Yervoy
(ipilimumab)
The EMA validated the Type II variation application for Opdivo plus Yervoy as a potential first-line treatment option for adult patients with unresectable or advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The application was based on results from the Phase 3 CheckMate -9DW trial. Validation confirms the submission is complete and begins the EMA’s centralized review procedure.
Krazati
(adagrasib)
The FDA granted accelerated approval for Krazati in combination with cetuximab as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The approval is based on results from the Phase 1/2 KRYSTAL-1 study.
Subcutaneous
nivolumab
The EMA validated the extension application to introduce a new route of administration (subcutaneous use) for nivolumab that includes a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial) across multiple previously approved adult solid tumor indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib. The validation, based on results from the Phase 3 CheckMate -67T trial, confirms the submission is complete and begins the EMA’s centralized review procedure.
Augtyro
(repotrectinib)
The FDA granted accelerated approval of Augtyro for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. The approval is based on results from the Phase 1/2 TRIDENT-1 trial.
Opdivo
The European Commission (EC) 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 makes Opdivo in combination with cisplatin and gemcitabine the first concurrent immunotherapy-chemotherapy approved for the treatment of adult patients with unresectable or metastatic UC in the first-line setting in the European Union. The approval is based on the results from the CheckMate -901 trial.
Opdivo +
Yervoy
The EMA validated the Type II variation application for Opdivo plus Yervoy for the first-line treatment of adult patients with microsatellite instability–high or mismatch repair deficient metastatic CRC. The application is based on results from the Phase 3 CheckMate -8HW trial. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
Subcutaneous
nivolumab
The FDA accepted the Biologics License Application (BLA) for the subcutaneous formulation of nivolumab co-formulated with Halozyme’s proprietary recombinant human hyaluronidase across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 29, 2024.
Clinical &
Research
Opdivo +
Yervoy
Results from the Phase 3 CheckMate -9DW trial showed the dual immunotherapy combination of Opdivo plus Yervoy meaningfully improved overall survival, the trial’s primary endpoint, compared to investigator’s choice of lenvatinib or sorafenib as a first-line treatment for patients with unresectable HCC. The results also demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of objective response rate.
Krazati
Results from the Phase 3 KRYSTAL-12 study evaluating Krazati compared to standard of care chemotherapy in patients with locally advanced or metastatic KRASG12C -mutated NSCLC who had previously received platinum-based chemotherapy, concurrently or sequentially with anti-PD-(L)1 therapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), the study’s primary endpoint. The KRYSTAL-12 study remains ongoing to assess the additional key secondary endpoint of overall survival.
Opdivo +
Yervoy
The Phase 3 CheckMate -73L trial did not meet its primary endpoint of PFS in unresectable, locally advanced stage III NSCLC. CheckMate -73L evaluated Opdivo with concurrent chemoradiotherapy (CCRT) followed by Opdivo plus Yervoy versus CCRT followed by durvalumab in patients with unresectable stage III NSCLC.
Hematology
Category
Asset
Milestone
Regulatory
Breyanzi
(lisocabtagene
maraleucel)
The FDA approved Breyanzi for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. This FDA approval is based on results from the MCL cohort of the Phase 1 TRANSCEND NHL 001 trial.
Breyanzi
The FDA granted accelerated approval for Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. The approval is based on results from the Phase 2 TRANSCEND FL trial.
Immunology
Category
Asset
Milestone
Clinical & Research
cendakimab
The pivotal Phase 3 trial evaluating the efficacy and safety of cendakimab in patients with EoE met both co-primary endpoints, demonstrating statistically significant reductions versus placebo in symptoms (dysphagia days) and esophageal eosinophil counts after 24 weeks of treatment. The overall safety profile of cendakimab through 48 weeks of treatment in the Phase 3 trial was consistent with previously reported EoE Phase 2 trial results, and no new safety signals were identified.
Sotyktu
(deucravacitinib)
Four-year results from the POETYK PSO long-term extension trial of Sotyktu treatment in adult patients with moderate-to-severe plaque psoriasis showed that, after four years of continuous Sotyktu treatment, clinical response was maintained in more than seven out of 10 patients for Psoriasis Area and Severity Index 75. In addition, the safety profile of Sotyktu at Year 4 remained consistent with the established safety profile, with no new safety signals identified.
Financial Guidance
Bristol Myers Squibb is raising portions of its 2024 line-item guidance as noted below.
2024 Line-Item Guidance
Non-GAAP2
April
(Prior)
July
(Updated)
Total Revenues
Low single-digit increase
Upper end of low single-
digit range
Total Revenues
(excl. F/X)
Low single-digit increase
Upper end of low single-
digit range
Gross Margin %
~74%
Between ~74% and ~75%
Operating Expenses1
Low single-digit increase
No Change
Other income/(expense)
~($250M)
~($50M)
Effective tax rate
~69%
~66%
Diluted EPS
$0.40 – $0.70
$0.60 – $0.90
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. To learn more about our priorities and goals, please visit our latest ESG report.
In June 2024, Bristol Myers Squibb was added to the 2023 Dow Jones Sustainability Index North America. This reflects the company’s evolved strategy and meaningful progress on its ESG efforts.
On May 22, 2024, the company announced ASPIRE (Accessibility, Sustainability, Patient-centric, Impact, Responsibility and Equity), a 10-year strategy to advance access to the company’s innovative treatments and help patients in low- and middle-income countries (LMICs) gain access to potentially life-saving medicines. This strategy supports the company’s commitment to reach more than 200,000 patients in LMICs by 2033 with its innovative treatments.
Conference Call Information
Bristol Myers Squibb will host a conference call today, Friday, July 26, 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 July 26, 2024, through 11:30 a.m. ET on August 9, 2024, by dialing in the U.S. toll free 1-877-344-7529 or international +1 412-317-0088, confirmation code: 2169814.