EX-99.3 4 q12022earningspresentati.htm PRESENTATION MATERIALS OF BRISTOL-MYERS SQUIBB COMPANY DATED APRIL 29, 2022 q12022earningspresentati
Q1 2022 Results April 29, 2022


 
Q1 2022 Results Not for Product Promotional Use Forward Looking Statement and Non-GAAP Financial Information 2 This presentation contains statements about the Company’s future plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated as a result of various important factors, including those discussed in the Company’s most recent annual report on Form 10-K and reports on Form 10-Q and Form 8-K. These documents are available on the SEC’s website, on the Bristol Myers Squibb website or from Bristol Myers Squibb Investor Relations. In addition, any forward-looking statements represent our estimates only as of the date hereof and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our estimates change. This presentation includes certain non-generally accepted accounting principles (GAAP) financial measures that we use to describe our company’s performance. The non-GAAP information presented 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 GAAP financial measure are available on our website at bms.com/investors. Also note that a reconciliation of certain forward-looking non-GAAP financial measures, however, is not provided due to no reasonably accessible or reliable comparable GAAP measures for such statements and the inherent difficulty in forecasting and quantifying such measures that are necessary for such reconciliation. Namely, we are not able to reliably predict the impact of certain specified items or currency exchange rates beyond the next twelve months. As a result, the reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is not available without unreasonable effort. 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.


 
Not for Product Promotional Use Q1 2022 Results Giovanni Caforio Board Chair and Chief Executive Officer 3


 
Q1 2022 Results Not for Product Promotional Use Operational Performance Strong commercial execution • Q1 sales: ~$11.6B,+5% YoY, +7% ex-FX • Double-digit Non-GAAP EPS growth in Q1 • Strong growth for in-line products & continued momentum from New Product Portfolio Pipeline Execution Key milestones • 2 first-in-class new product approvals: Camzyos in oHCM & Opdualag in 1L melanoma • 7 additional approved indications1 & 3 clinical filings2 across therapeutic areas globally • Positive Ph2 for deucravacitinib in SLE; registrational program expected to initiate by end of 2022 • Initiated Opdualag 2L+ CRC study Financial Strength • Adjusting 2022 Full Year Guidance • Balance sheet strength & strong cash flow generation • ~$3.8B cash from operating activities • ~$15B total cash and marketable debt securities Q1 2022 Performance 41Approvals: U.S. – Opdivo in neo-adjuvant NSCLC (CM-816); EU - Breyanzi 3L+ LBCL, Opdivo+Yervoy in 1L ESCC (CM-648); Opdivo in adjuvant MIUC (CM-274) & 1L ESCC (CM-648); Japan – Opdivo in adjuvant MIUC (CM-274) & Abecma 3L+ MM 2Clinical filings – Breyanzi 2L LBCL in U.S. & Japan; Opdivo in neo-adjuvant NSCLC (CM-816) in EU


 
Q1 2022 Results Not for Product Promotional Use 2022 Key Milestones Opdivo (+/- Yervoy) U.S./EU expected approvals:  1L ESCC (CM-648)  Neo-adj lung EFS (CM-816) (U.S.) Opdualag  1L melanoma U.S. approval  Initiation 2L+ CRC Ph3 bempeg  1L melanoma  1L renal  1L bladder Breyanzi  2L LBCL U.S. approval  3L+ LBCL EU approval Abecma  2L+ MM Ph2 (KarMMa-2) iberdomide  Initiation 2L+ MM Ph3 (EXCALIBER) CC-92480  4L+ MM Ph1/2 Portfolio Depth Provides Significant Near-term Catalysts 5Milestones represent data read-outs unless otherwise specified To be expanded to include regulatory milestones pending future registrational successes deucravacitinib  PsO U.S. approval  SLE Ph2 cendakimab  AD Ph2 Camzyos  oHCM U.S. approval  oHCM Ph3 (VALOR)  Initiation nHCM Ph3 milvexian  SSP Ph2 2023/2024 Key Milestones Opdivo (+/- Yervoy) Metastatic:  1L CRPC (CM-7DX)  1L HCC (CM-9DW) Early Stage:  Adj. HCC (CM-9DX)  Adj. RCC (CM-914)  Peri-adj lung (CM-77T)  Peri-adj MIBC (CM-078)  Adj. NSCLC (ANVIL, co- op group) Opdualag  1L melanoma EU approval  Initiation 1L lung Ph3  2L HCC Ph2 bempeg  Neo-adj. cis-ineligible MIBC Breyanzi  3L+ FL  3L+ CLL Abecma  3L+ MM Ph3 (KarMMa-3) alnuctamab BCMA TCE  Initiation of pivotal trial iberdomide  Initiation of Post transplant maintenance Ph3 H2H vs Rev  Initiation of NDMM Ph3 H2H vs. Rev CC-92480  Initiation triplet 2L+ MM Ph3 Reblozyl  1L MDS Ph3 (COMMANDS)  1L MF Ph3 (INDEPENDENCE) deucravacitinib  PsO EU approval  PsA Ph3  CD & DLE Ph2  UC Ph2 (IM011- 127) cendakimab  EoE Ph3 Zeposia  CD Ph3 Camzyos  HFpEF Ph2 (EMBARK)


 
Q1 2022 Results Not for Product Promotional Use Two additional $4B+1 Medicines Now Approved 6 1NRA sales in 2029 NRA: Non-Risk Adjusted sales subject to positive registrational trials and health authority approval Deucravacitinib Three First-in-Class Opportunities Clinically meaningful PFS & OS First-in-class myosin inhibitor approved in U.S. in oHCM Potential first-in-class selective allosteric TYK-2 inhibitor First-in-class LAG-3 inhibitor, FDC with nivolumab approved in U.S. in 1L melanoma 3rd I-O agent approved Potential expansion in lung, liver, & colorectal cancers First novel option to treat underlying condition in oHCM Exciting VALOR Ph3 data at ACC 2022 Future opportunities to expand indications (e.g. nHCM) U.S. PDUFA September 10th Phase 3 in PsA ongoing; achieved PoC in SLE with registrational trial start expected end of 2022 Superior efficacy to current oral SOC in mod-severe psoriasis; favorable safety & tolerability profile Oral of choice profile in psoriasis U.S. Approval April 28thU.S. Approval March 18th


 
Q1 2022 Results Not for Product Promotional Use Driving Growth Through the Decade 7 ($12B – $14B) +$8B – $10B +$10B – $13B 2020 Revenues Key LOE Products In-Line Products Primarily I-O & Eliquis 2025 Revenues New Product Portfolio Growth 2020 - 2025 Growth 2025 - 2029 2025 Revenues 2029 Revenues LOE Products Primarily Eliquis & Opdivo Additional growth from New Product Portfolio Advancing Robust Pipeline Additional Optionality from Disciplined Business Development Maintain low to mid 40s operating margin** Key LOE Products = Revlimid, Abraxane, Sprycel, and Pomalyst Financial projections may contain non promoted sales, BMS promotes only according to label *At constant exchange rates on a risk-adjusted basis; **Non-GAAP: There is no reliable or reasonable estimable comparable GAAP metric for this forward-looking information Continuing Business Growth Low to mid-single digit revenue CAGR*


 
Not for Product Promotional Use David Elkins Chief Financial Officer 8 Q1 2022 Results


 
Q1 2022 Results Not for Product Promotional Use Strong Total Company Performance 9 Total Company +$0.6B, +5% YoY, +7% Ex-FX $7.8 $8.6 $3.3 $3.0 Q1 21 Q1 22 Recent LOEs In-Line & New Products $B Net Sales YoY % Ex-FX Total Company $11.6 5% 7% In-Line Products $8.3 8% 11% New Product Portfolio $0.4 * * In-Line Products & New Product Portfolio $8.6 11% 13% Recent LOEs $3.0 (8%) (6%) * In excess of +100%


 
Q1 2022 Results Not for Product Promotional Use New Product Portfolio Sales Performance 10 Contributed $350M in Q1’22; more than doubled vs PY Anticipated approval of deucravacitinib PDUFA: September 10, 2022 $112 $156 $67 $18 $36 $44 $15 $23 $16 $18 $161 $350 Q1 2021 Q1 2022 Q1 2022 vs Q1 2021 Global Net Sales $M Reblozyl Abecma Zeposia Breyanzi Onureg Inrebic Opdualag Strong outlook for future growth Recent Approvals


 
Q1 2022 Results Not for Product Promotional Use 11 Q1 2022 Solid Tumor product summary Opdivo • U.S. growth driven by demand in 1L lung, 1L renal, 1L gastric, adj. esophageal & adj. bladder cancer • Ex-U.S. growth from new launches in multiple geographies • Continued growth expected from current & new indications Opdualag (launched in U.S. March 18, 2022) • 3rd approved I-O agent • $3M inventory build in Q1 2022 • Potential to be new SOC in 1L melanoma Key Commentary $M YoY % Ex-Fx $1,923 +12% +15% $515 +13% +16% $214 (32%) (31%) $6 --- --- Q1 Global Net Sales


 
Q1 2022 Results Not for Product Promotional Use 12 Q1 2022 Cardiovascular product summary • Continues to be the best-in-class medicine in an expanding category • Strong underlying demand in U.S., ~10% TRx growth • Continues to be #1 NOAC in key international markets Key Commentary $M YoY % Ex-Fx $3,211 +11% +14% Q1 Global Net Sales U.S. approval April 28, 2022 • First-in-class myosin inhibitor indicated for NYHA class II & III symptomatic oHCM • Significant clinical, functional and QoL benefits • Dosing & monitoring aligns to HCM clinical practice & patient management • Leverages strong CV leadership, relationships & capabilities • Initial focus on top HCM centers Key Commentary


 
Q1 2022 Results Not for Product Promotional Use 13 Q1 2022 Hematology product summary Revlimid – Impacted by generic entry • Expect Q2’22 Revenues of ~$2B & FY’22 of $9 - $9.5B Pomalyst – Increased demand as patients move into earlier lines and extend treatment duration Reblozyl • Strong demand in the U.S.; encouraging trends reducing time from ESA failures & increasing dose; remain focused on patient identification & dosing education to extend duration & benefit to patients • Expansion in international markets based on reimbursement timing Abecma – Continued strong demand; on track for expanded capacity in mid-2022 Breyanzi - Growing demand from best-in-class profile; planning for U.S. PDUFA in 2L LBCL - June 24, 2022 Key Commentary 1 $M YoY % Ex-Fx $2,797 (5%) (4%) $826 +7% +9% $483 +3% +6% $156 +39% +41% $75 (12%) (9%) $67 --- --- $44 --- --- $23 +53% +55% $18 +13% +14% Q1 Global Net Sales


 
Q1 2022 Results Not for Product Promotional Use 14 Q1 2022 Immunology product summary Orencia • Continued growth in U.S. due to higher demand & expanded market share Zeposia • Sales increased due to higher demand including expansion into UC • Encouraging leading indicators in UC: Increased trialists & higher new patient starts • Expect UC to further contribute in 2H 2022 with expansion in 2023 Key Commentary $M YoY % Ex-Fx $792 +4% +6% $36 +100% * Q1 Global Net Sales Deucravacitinib Anticipated U.S. approval September 10, 2022 * In excess of +100%


 
Q1 2022 Results Not for Product Promotional Use US GAAP Non-GAAP $ in billions, except EPS Q1 2022 Q1 2021 Q1 2022 Q1 2021 Total Revenues, net 11.6 11.1 11.6 11.1 Gross Margin % 78.8% 74.3% 79.2% 78.1% Operating Expenses1 (4.1) (3.9) (4.0) (3.9) Effective Tax Rate 23.9% 19.8% 15.9% 16.8% Diluted EPS 0.59 0.89 1.96 1.74 Diluted Shares Outstanding (# in millions) 2,164 2,265 2,164 2,265 Q1 2022 Financial Performance 15 US P No - AAP $ in millions, except EPS Acquired IPR&D and Licensing Income, Net (280) (10) (280) (10) Diluted EPS Impact (0.10) - (0.10) - 1 Operating Expenses = MS&A and R&D; does not include Acquired IPR&D and Amortization of acquired intangibles


 
Q1 2022 Results Not for Product Promotional Use Balanced Approach to Capital Allocation 16 *Cash includes cash, cash equivalents and marketable debt securities **Non-GAAP: There is no reliable or reasonable estimable comparable GAAP metric for this non-GAAP forward-looking information ***Subject to Board approval $B Q1 2022 Total Cash* ~$15B Total Debt ~$45B • Prioritize small & mid-sized bolt-on opportunities • Replenish & diversify portfolio • Continued debt reduction; ~$12B in maturities from 2022-2024 • Maintain strong investment-grade credit rating Business Development Debt Reduction Returning Cash to Shareholders • Continued dividend growth*** ‒ 13th consecutive dividend increase announced Dec ’21 • Opportunistic share repurchase ‒ $5B ASR agreement executed in Q1’22; 85% settled upon execution; remainder to be settled in Q2/Q3$45B - $50B in free cash flow** 2022 - 2024 $3.8 $3.1 $5.3 $4.1 $3.8 Cash flow from Operations $B Q1 2021 Q2 2021 Q3 2021 Q4 2021 Q1 2022


 
Q1 2022 Results Not for Product Promotional Use February (prior) April (Revised) February (prior) April (Revised) Commentary Total net Sales ~$47B or low single-digit increase In-line with 2021 ~$47B or low single-digit increase In-line with 2021 FX impact & lower ex-US Revlimid sales Recent LOE Products1 ~$10.5B or double-digit decline ~$10B or double-digit decline ~$10.5B or double-digit decline ~$10B or double-digit decline Lower ex-US Revlimid sales Revlimid $9.5 - $10B $9 - $9.5B $9.5 - $10B $9 - $9.5B In-line Products & New Product Portfolio ~$36.5B or low double-digit increase No Change ~$36.5B or low double-digit increase No Change Gross Margin % ~78% No Change ~78% No Change Operating Expenses2 Approx. 10% decline Mid single-digit decline In-line with 2021 Low single-digit decline FX & cost discipline Tax Rate ~24% ~22% ~16.5% No Change Diluted EPS $3.37 - $3.67 $2.92 - $3.22 $7.65 - $7.95 $7.44 - $7.74 Includes net impact of ($0.21) from Acquired IPRD & licensing income3 2022 Guidance 17 US GAAP Non-GAAP 1Key LOE Products = Revlimid & Abraxane 2Operating Expenses = MS&A and R&D; does not include Acquired IPR&D and amortization of acquired intangibles 3Comprises the net impact of ($0.10) from Acquired IPRD & licensing income incurred in Q1 2022 and an additional ($0.11) due to the buyout of future royalty obligation related to mavacamten that occurred in April 2022. Does not include estimate of Acquired IPRD & licensing income for remainder of 2022


 
Q1 2022 Results Not for Product Promotional Use Q&A Giovanni Caforio, M.D. Board Chair, Chief Executive Officer David Elkins Executive VP, Chief Financial Officer 18 Chris Boerner, Ph.D. Executive VP, Chief Commercialization Officer Samit Hirawat, M.D. Executive VP, Chief Medical Officer, Global Drug Development


 
Q1 2022 Results Not for Product Promotional Use Q1 2022 Opdivo Sales Mix 19 23% 24% 26% 11% 17% U.S. Sales Mix Note: percentages are approximate 30% 21% 23% 4% 23% Ex-U.S. Sales Mix


 
Q1 2022 Results Not for Product Promotional Use Q1 2022 Eliquis NBRx/TRx Share 20Rx Source: Symphony Health 54% 57% 20% 17% 26% 26% Q1 2021 Q1 2022 TRx Share - US Other NOACsWarfarinEliquis 63% 61% 12% 10% 25% 29% Q1 2021 Q1 2022 NBRx Share – US


 
Q1 2022 Results Not for Product Promotional Use 2022 Key News Flow 21 Asset Timing Opdivo Approval in 1L ESCC (CM-648) U.S. PDUFA - May 28, 2022 Approved in EU Opdivo Approval in Neo-Adj. Lung EFS (CM-816) Approved in U.S. MAA under review Opdualag Approval in 1L Melanoma (RELATIVITY-047) Approved in U.S. MAA under review Bempegaldesleukin 1L Melanoma/Adjuvant Melanoma 1L Renal Cell Carcinoma (RCC) 1L Muscle Invasive Urothelial Carcinoma Program discontinued Breyanzi Approval in 3L+ LBCL Approved in U.S. & EU Breyanzi Approval in 2L LBCL U.S. PDUFA – June 24, 2022 Asset Timing deucravacitinib Approval in mod to severe PsO POETYK PSO-1 & PSO-2 U.S. PDUFA – September 10, 2022 MAA under review deucravacitinib Ph2 in Systemic Lupus Erythematosus (PAISLEY) Positive POC Registration program to initiate end of 2022 Camzyos Approval in symptomatic obstructive HCM (EXPLORER-HCM) Approved in U.S. MAA under review Camzyos Ph3 in obstructive HCM NYHA Class III & IV (VALOR) Positive Topline February 2022 milvexian (FXIa inhib.) Ph 2 in SSP (+TKR in VTEp to inform Ph3) Expect data in-house mid 2022


 
Not for product promotional use Hematology Fibrosis HSP47 LPA1 Antagonist Immunology Oncology Anti-Fucosyl GM1 TIGIT Bispecific Anti-NKG2A Anti-SIRPα1 AR LDD Anti-CTLA-4 NF Anti-CCR8 Anti-CTLA-4 Probody alnuctamab BCMA TCE CD3xPSCA (Avencell)2 IL-12 Fc Anti-IL-8 Anti-TIGIT BET Inhibitor (BMS-986158) CD19 NEX T BCMA ADC TGFβ Inhibitor iberdomide 1 - In development for solid tumors and hematology 2 - BMS has an exclusive option to license and/or option to acquire MK2 Inhibitor Anti-CD40 IL2-CD25 cendakimab branebrutinib deucravacitinib Cardiovascular FA-RelaxinFXIa Inhibitor 22 Phase 1 Phase 2 Phase 3 Marketed A/I CELMoD (CC-92480) GSPT1 CELMoD (CC-90009) BET Inhibitor1 (CC-90010) CD33 NKE CD47xCD20 Neuroscience Anti-Tau (Prothena)2 AHR Antagonist (Ikena)2 S1PR1 Modulator afimetoran (TLR 7/8 Inhibitor) NME Active Clinical Development Portfolio STING Agonist danicamtiv BCMA NEX T Cardiac Myosin Inhibitor milvexian (FXIa Inhibitor) TYK2 Inhibitor GPRC5D CAR T Anti-CTLA-4 NF- Probody CK1α CELMoD ROMK Inhibitor BTK Inhibitor BCMA NKE ROR1 CAR T FAAH/MGLL Dual Inhibitor Subcutaneous nivolumab eIF2b Activator MAGE A4/8 TCE Data as of Apr 22nd, 2022 A/I CELMoD (CC-99282) farletuzumab ecteribulin LSD1 Inhibitor Anti-ILT4


 
Q1 2022 Results Not for Product Promotional Use Our Commitment as a sustainable organization Embracing environmental stewardship 23 • Experienced & diverse Board ― Board oversight of strategy & key enterprise risks ― 60% female & ethnically diverse directors • Shareholder rights ― Regular shareholder engagement ― Proxy access ― Special meeting right (15%) Environment GovernanceSocial K e y P ri o ri ti e s C o n c re te C o m m it m e n ts 2021 • ≥ 25% new clinical trial sites in diverse metro areas 2022 • Gender parity at executive level • 2X representation for Black/African American & Hispanic/Latino executives 2025 • $1B spend with diverse suppliers 2024 • Science-based emissions reduction targets established 2030 • 100% renewable electricity 2040 • Net neutral GHG • 100% EV fleet • 100% equitable water use • Zero waste to landfill Maintaining highest ethics, integrity & compliance Upholding Board oversight & accountability Promoting product quality & safety Cultivating diversity, equity & inclusion Ensuring health equity, patient access & innovation