Q3 2023 Results
October 26, 2023
Forward Looking Statements and Non-GAAP Financial Information
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, including our ability to complete the acquisition of Mirati Therapeutics, Inc. and
- 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 atwww.bms.com/investors.
Also note that a reconciliation of forward-lookingnon-GAAP gross margin, non-GAAP operating 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.
Q3 2023 Results | Not for Product Promotional Use | 2 |
Q3 2023 Results
Giovanni Caforio, MD
Board Chair and Chief Executive Officer
Q3 2023 Results
Chris Boerner, PhD
Chief Operating Officer
Chief Executive Officer, effective November 1, 2023
Q3 2023 Performance
Q3 Global Net Sales
• 11.0B; (2%) YoY; (3%) Ex-FX*
Commercial | In-Line Brands & New Product Portfolio | Financial |
& Financial | • ~$9.3B; +8% YoY; +7% Ex-FX* | |
Outlook | ||
Execution | ||
Earnings per Share (EPS)
• GAAP $0.93, +24% YoY
• Non-GAAP* $2.00, +1% YoY
Medium-Term Financial Targets*
Reaffirms1:
- Low-to-midsingle digit revenue CAGR2
- Low double-digit revenue CAGR2 ex-Rev/Pom
- $8-10Brevenue growth from in-line brands3
Adjusts:
- >$10B growth from new product portfolio in 2026
- Operating margin to >37%4
• Reblozyl: U.S. approval in 1L MDS | ||||||
associated anemia (COMMANDS) | ||||||
Business | • Entered into acquisition agreement | Pipeline | • Opdivo: U.S. & EU approval in Stage II | |||
with planned close by 1H 2024 | adj. melanoma (CM-67K); positive Ph3 in | |||||
Development | Execution | |||||
• Strengthens & diversifies Oncology | SC nivolumab (CM-67T) & peri-adj. lung | |||||
(CM-77T) | ||||||
portfolio | ||||||
• LPA1 antagonist: Established PoC in PPF | ||||||
Q3 2023 Results | *See "Forward-Looking Statements and Non-GAAP Financial Information" and "Bristol Myers Squibb Company Reconciliation of Certain GAAP | 5 | ||||
Line Items to Certain Non-GAAP Line Items" | Not for Product Promotional Use | |||||
1. 2020-2025 Financial Targets 2. At constant exchange rates on a risk-adjusted basis 3. Primarily I-O & Eliquis 4. Target through 2025 |
Our Goal is to Deliver Sustainable Growth
Four Key Enablers
Evolve R&D for scientific leadership
Strong commercial execution to realize value of our marketed portfolio
Execute strategic capital allocation to further strengthen our growth profile
Foster a high- performance culture and attract & retain industry-leadingtalent
We are driven by our mission: Transforming patients' lives through science
Q3 2023 Results | Not for Product Promotional Use | 6 |
Solid Momentum in Q3 & Accelerating Future Growth
Key In-Line Products
New Product Portfolio
Outlook*
$ in millions
+67% ex-FX*
$928
• Expect >$10B revenue |
• Strong U.S. demand |
growth offset by gross- |
to-net adjustments |
$553** | $21 | |
$32 | ||
$5 |
$43 $66
$68 $92 $93
$29
from new product |
portfolio in 2026 |
• Focused on product |
acceleration to enable |
• | Continued demand |
growth | |
• | Delivered key clinical |
$1 | ||
$44 | ||
$107 |
$69 $84
$190
$123
$166
$248
future growth |
• Planned expansion of |
new product portfolio |
with repotrectinib1 & |
Krazati2 |
milestones to enable |
future growth |
Q3 2022 | Q3 2023 | |||||||
Reblozyl | Opdualag | Zeposia | Abecma | Breyanzi | ||||
Camzyos | Sotyktu | Onureg | Inrebic | |||||
Q3 2023 Results | *See "Forward-Looking Statements and Non-GAAP Financial Information" | 1. | U.S. PDUFA: November 27, 2023 | Not for Product Promotional Use | 7 |
2. | Subject to satisfaction of customary closing conditions; | ||||
**Q3 2022 sales: Camzyos - $5M & Sotyktu - $1M | |||||
anticipated closing by 1H 2024 | |||||
Strong Delivery from our R&D Engine Since R&D Day
Oncology
Opdivo
- U.S. approval in Stage II adj. melanoma
- Peri-adj.lung & 1L MIUC presented at ESMO
- Met co-primary endpoints for SC nivolumab1
Krazati2
- 1L lung TPS ≥ 50% encouraging Ph2 data at
ESMO
Immunology
LPA1 antagonist
- Breakthrough Therapy Designation granted in PPF
CD19 NEX T Cell Therapy
- Enrolling patients in Ph1 severe, refractory SLE trial
- Achieved FDA clearance to initiate MS trial
Hematology
Reblozyl
- U.S. approval in 1L MDS associated anemia with a broad label
Other assets
- Data to be presented on key assets at ASH 2023
Q3 2023 Results | 1. | Subcutaneous nivolumab could provide U.S. approval in indications representing 65-75% of Opdivo business & benefit patients into the early 2030s | Not for Product Promotional Use | 8 |
2. | Subject to satisfaction of customary closing conditions; anticipated closing by 1H 2024 |
Mirati Therapeutics: Strong Strategic Fit
Extending in IO
- Best-in-class KRASG12C inhibitor approved in 2L+ mutated NSCLC; confirmatory Ph3 results expected 1H 2024
- Potential KRASG12C mutated tumor opportunities: 1L NSCLC; 2L & 3L+ CRC
Indication
1L NSCLC
2L CRC
3L+ CRC
Development
TPS ≥ 50%: Krazati + pembrolizumab
TPS < 50%: Krazati + pembrolizumab + chemo
Krazati + cetuximab
Status
Ph3 initiation by YE 2023
Ph2 data expected in 1H 2024
Ph3 data expected in 2024
Ph2 submission expected by YE 2023
Diversifying beyond IO
repotrectinib1
(U.S. PDUFA: 11/27/23)
2
Selective PRMT5/MTA inhibitor (MRTX1719): Potential first-in-class asset
- Ph2 expected to initiate 1H 2024; Fast Track Designation granted
Early Clinical Programs: Additional opportunities from KRAS inhibitors & enabling programs (e.g., SOS1 inhibitor)
Planned close by 1H 20242
Q3 2023 Results | 1. | Acquired from Turning Point Therapeutics | Not for Product Promotional Use | 9 |
2. | Subject to satisfaction of customary closing conditions; anticipated closing by 1H 2024 | |||
Continued Strong Pipeline Execution
2023 Key Milestones
2024/2025 Key Milestones
Opdivo (+/- Yervoy)
Opdualag
repotrectinib
Abecma
Breyanzi
Early Stage:
Neo-adjuvant NSCLC Ph3 (CM-816) approval in EU
Metastatic:
- 1L mCRPC Ph3 (CM-7DX)
- 1L NSCLC Ph21
ROS1+ NSCLC (TRIDENT-1) U.S. filing
3-5L MM Ph3 (KarMMa-3) filing
Initiation NDMM Ph3 (KarMMa-9)
2L TE LBCL EU approval
3L+ CLL Ph1/2 (TRANSCEND-CLL)
3L+ FL Ph2 (TRANSCEND- FL)
iberdomide
Reblozyl
Sotyktu
LPA1 Antagonist
Camzyos
LIBREXIA (milvexian)
Initiation of pivotal
post-transplant maintenance H2H vs Revlimid
1L MDS (COMMANDS) U.S. filing
Mod-to-severe PsO EU approval
- CD Ph2 (IM011-023)
- UC Ph2 (IM011-127)
Initiation IPF Ph3 PPF Ph2 (IM027-040)
oHCM EU approval
Initiation Ph3
program2
Opdivo (+/- Yervoy)
Opdualag
alnuctamab
BCMA TCE
Metastatic:
- 1L HCC Ph3 (CM-9DW)
- 1L+ MSI High CRC Ph3 (CM-8HW)
Early Stage:
Peri-adj NSCLC Ph3 (CM-77T)
- Peri-adjMIBC Ph3 (CM-078)
- Adj HCC Ph3 (CM-9DX)
- Stage III Unresectable NSCLC Ph3 (CM-73L)
- Adj NSCLC Ph3 (ANVIL, co-op group)
- 1L HCC Ph2
- 2L+ HCC Ph2
- 2L/3L+ MSS mCRC Ph3
- Initiation MM Ph3
Reblozyl | 1L MF Ph3 |
(INDEPENDENCE) | |
cendakimab | EoE Ph3 |
Sotyktu | PsA Ph3 |
Zeposia | CD maintenance Ph3 |
(YELLOWSTONE) | |
Q3 2023 Results
1. | Data readout anticipated early 2024 | Milestones represent data readouts unless otherwise specified; | Not for Product Promotional Use | 10 |
2. | ACS, SSP, AF trials conducted by Janssen | subject to positive registrational trials and health authority approval | ||
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Bristol-Myers Squibb Company published this content on 26 October 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 October 2023 11:51:28 UTC.