EX-99.3 4 q32021earningspresentati.htm PRESENTATION MATERIALS OF BRISTOL-MYERS SQUIBB COMPANY DATED OCTOBER 27, 2021 q32021earningspresentati
Q3 2021 Results October 27, 2021


 
Q3 2021 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 statements, 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 statements that are necessary for such reconciliation.


 
Not for Product Promotional Use Q3 2021 Results Giovanni Caforio Board Chair and Chief Executive Officer 3


 
Q3 2021 Results Not for Product Promotional Use Operational Performance Strong commercial execution • Sales of $11.6B in Q3; +10% YoY • Continued momentum for in-line brands & new product portfolio Pipeline Execution Key milestones • Relatlimab U.S. & EU filing, U.S. priority review with PDUFA of March 2022 • Multiple regulatory accomplishments: Opdivo, Abecma, Zeposia, & mavacamten • ] Financial Strength Strong financial results & outlook • Continued Revenue & EPS growth • Reaffirm 2021 Revenue & raise lower-end of Non-GAAP EPS guidance range • Balance sheet strength & strong cash flow generation; debt repayments of ~$6.0B & executed share repurchases of ~$3.5B YTD Intellectual Property • Successful decision on Eliquis IP; LOE expected in April 2028* Q3 2021 Performance 4*subject to additional appeals and challenges


 
Q3 2021 Results Not for Product Promotional Use Opdivo (+/- Yervoy) U.S./EU expected approvals: 1L RCC (9ER) , 1L GC (649, O+Chemo), adj Eso (577) adj MIBC (274) 1L Esophageal (CM-648) Opdivo return to annual growth Relatlimab 1L Melanoma w/ Opdivo Ph3 Breyanzi 3L+ DLBCL U.S. / EU approval3 2L TE and TNE DLBCL 3L+ CLL3 Abecma 4L+ MM U.S.1 / EU approval Iberdomide + dex 4L+ MM Ph 1b/2a Deucravacitinib PsO (2nd study) Ph3 & U.S. filing UC Ph2 (POC) Zeposia UC U.S. / EU approval Cendakimab Initiation of Ph3 Factor XIa inh. Total Knee Replacement VTEp Ph2 (POC) Mavacamten oHCM U.S. filing & approval2 Opdivo (+/- Yervoy) Metastatic 1L HCC (CM-9DW) Adjuvant Neo-adj Lung EFS (CM-816) Peri-adj Lung (CM-77T) Bempeg 1L melanoma3 & 1L renal Breyanzi 3L+ Follicular lymphoma Abecma 3L+ MM (KarMMa-3) Ph3 2L+ MM (KarMMa-2) POC CC-92480 4L+ MM Ph1/2 CC-93269 (TCE) Initiation of pivotal trial Deucravacitinib PsO U.S./EU approval CD & Lupus Ph2 (POC) Zeposia CD Ph3 Factor XIa inh. Secondary Stroke Prevention Ph2 (POC) Reblozyl 1L MDS (ESA naïve) COMMANDS Ph3 Ph 1/2 Pipeline >20 POC decisions 5 2021 Key Milestones Execution Scorecard • 2020-2025:  Low to mid-single digit revenue CAGR*  Low double-digit revenue CAGR for Continuing business* • Operating margins low to mid 40%s** • ~$3B of synergies by end of 2022 • $45B - $50B of free- cash flow 2021-2023** Financial Expectations 2022/2023 Key Milestones To be expanded to include regulatory milestones pending future registrational successes On track based on 2021 guidance 1Approved after 4 prior lines of therapy 2 PDUFA January 28, 2022 3 Expected in 2022 *At constant exchange rates – Non-GAAP: there is no reliable or reasonable estimable comparable GAAP metric for this Non-GAAP forward-looking information; **Non-GAAP: there is no reliable or reasonable estimable comparable GAAP metric for this forward-looking information


 
Q3 2021 Results Not for Product Promotional Use Strong foundation for future growth 6 Strong execution Executing launches & advancing pipeline Significant opportunity for portfolio growth & renewal Foundation Established First/Best-in-Class Assets mavacamten deucravacitinib relatlimab Strong Innovation Engine Key Late-Stage Pipeline Opportunities milvexian iberdomide CC-92480 cendakimab BCMA TCE MORab-202 Strength across 4 therapeutic areas Broad & Diversified pipeline Depth across multiple research platforms Robust Commercial performance Multiple Approvals and launches Disciplined Business development Anticipated Launches


 
Not for Product Promotional Use David Elkins Chief Financial Officer 7 Q3 2021 Results


 
Q3 2021 Results Not for Product Promotional Use Net Sales $ in Billions Vs. Prior Year $3.3 11% $2.4 15% $1.9 7% $0.9 10% Strong Q3 performance in key franchises Net Sales $ in Billions Vs. Prior Year $0.9 5% $0.6 1% $0.5 15% $0.3 22% 8 ▲ ▲ ▲ ▲ ▲ ▲ ▲ Q3 2021 Total Sales: $11.6B, up 10% vs PY


 
Q3 2021 Results Not for Product Promotional Use US: Continued significant demand growth • Continued strong underlying demand • ~14% TRx growth Q3 2021 Eliquis performance 9Rx Source: Symphony Health Significant future growth opportunity • Expect to continue to grow share within an expanding class International: Strong demand growth • Continues to be #1 OAC in key markets Global net sales up 15% in Q3 51% 56% 23% 19% 26% 25% Q3 2020 Q3 2021 TRx Share - US Other NOACs Warfarin Eliquis 60% 63% 14% 12% 26% 25% Q3 2020 Q3 2021 NBRx Share – US


 
Q3 2021 Results Not for Product Promotional Use Global net sales up 7% in Q3 U.S. • Continued growth (+4% vs. PY) offset by Q2 inventory destocking (~$40m); 5% demand growth QoQ • 1L lung* shares in low double-digits • Leadership position in 1L renal • Strong initial adoption in Upper GI & adj. esophageal; approved in adj. bladder cancer International • Strong growth (+11% vs. PY) driven by increased demand for new indications & expanded access Q3 2021 Opdivo performance 10 24% 24%28% 7% 17% Approx. U.S. Sales Mix Note: percentages approximate based on tumor ranges 30% 23% 25% 4% 18% Approx. Ex-U.S. Sales Mix NSCLC RCC Melanoma Upper GI All others Near term growth drivers • Momentum from recent launches • Potential next launches: ― 1L ESCC (CM-648): PDUFA May ’22 & filed in EU *excluding EGFR/ALK patients


 
Q3 2021 Results Not for Product Promotional Use Q3 2021 Multiple Myeloma performance 11 $548 $586 $229 $265 Q3 2020 Q3 2021 Global sales growth of 11% • US sales growth of 11% ― Increased use of triplet regimens & longer treatment duration • International sales growth of 10% ― Demand from triplet regimens & maintenance use Global sales growth of 10% • Demand growth from new triplet regimens & use in earlier lines Global Net Sales $2,080 $2,303 $947 $1,044 Q3 2020 Q3 2021 US Ex-US


 
Q3 2021 Results Not for Product Promotional Use Advancing new product portfolio launches 12 $112 $128 $160 $24 $71 $18 $28 $40 $17 $30 $16 $16 $22 $15 $12 $21 $161 $225 $344 Q1 2021 Q2 2021 Q3 2021 Q3 2021 Global Net Sales Reblozyl Abecma Zeposia Breyanzi Inrebic Onureg • Growth from underlying demand & ~$20-25m inventory build • Encouraging NCCN update • Continue to secure reimbursement in international markets • First-in-class BCMA CAR T • Robust demand continues to exceed supply • Increased demand driven by best-in-class profile • Opportunity to expand into earlier lines (2L LBCL) • Momentum from MS launch • #1 S1P modulator in written Rx in MS • UC launch progressing well - focused on building demand & broadening access • Positive CHMP opinion in UC • Establishing profile in 1L AML response maintenance • Focused on increasing adoption & patient adherence


 
Q3 2021 Results Not for Product Promotional Use US GAAP Non-GAAP $ in billions, except EPS Q3 2021 Q3 2020 Q3 2021 Q3 2020 Total Revenues, net 11.6 10.5 11.6 10.5 Gross Margin % 80.3% 76.3% 81.1% 80.6% MS&A 1.8 1.7 1.8 1.7 R&D 3.3 2.5 2.4 2.3 Effective Tax Rate 28.0% 16.8% 14.9% 17.1% Diluted EPS 0.69 0.82 2.00 1.63 Diluted Shares Outstanding (# in millions) 2,243 2,290 2,243 2,290 Q3 2021 Financial Performance 13


 
Q3 2021 Results Not for Product Promotional Use Significant financial flexibility to support a balanced approach to capital allocation 14 $B Q3 2021 Total Cash** ~$15.7B Total Debt ~$44.7B Net Debt Position ~$29.0B *Subject to Board approval **Cash includes cash, cash equivalents and marketable debt securities Committed to reducing debt • ~$6.0B in debt reduction YTD • Maintain strong investment-grade credit ratings Returning capital to shareholders • Continued dividend growth* • Executed ~$3.5B share repurchase YTD; ~$3.0B discretionary authorization available & remain opportunistic Future innovation through business development • Strategically aligned • Scientifically sound • Financially attractive


 
Q3 2021 Results Not for Product Promotional Use 2021 Guidance 15 GAAP Non-GAAP July (prior) October (revised) July (prior) October (revised) Net Sales High single-digit increase High single-digit increase High single-digit increase High single-digit increase Gross Margin % ~79% ~79% ~80% ~80% MS&A Expense In line with 2020 In line with 2020 Low single-digit increase Low single-digit increase R&D Expense Low single-digit decrease Low single-digit increase Mid single-digit increase Mid single-digit increase Tax Rate ~23% ~26% ~16% ~16.5% Diluted EPS $2.77 - $2.97 $2.68 - $2.83 $7.35 - $7.55 $7.40 - $7.55 Raised lower-end of Non-GAAP EPS guidance range


 
Q3 2021 Results Not for Product Promotional Use Q&A Giovanni Caforio, M.D. Board Chair, Chief Executive Officer David Elkins Executive VP, Chief Financial Officer 16 Chris Boerner, Ph.D. Executive VP, Chief Commercialization Officer Samit Hirawat, M.D. Executive VP, Chief Medical Officer, Global Drug Development


 
Q3 2021 Results Not for Product Promotional Use 2021 News Flow 17 Asset Timing Opdivo Approval in 1L renal (CM-9ER) Approved in U.S. & EU Opdivo Approval in 1L gastric (CM-649) Approved in U.S. & EU Opdivo Approval in adjuvant esophageal (CM-577) Approved in U.S. & EU Opdivo Approval in adjuvant MIBC (CM-274) Approved in U.S. Opdivo CM-648 in 1L esophageal U.S. PDUFA - May 28, 2022 MAA under review relatlimab + nivo vs nivo mono 1L Melanoma CA224-047 U.S. PDUFA - March 19, 2022 MAA under review Breyanzi Approval in 3L+ LBCL Approved in U.S. MAA under review2 Breyanzi 2L DLBCL (TRANSFORM) 3L+ CLL (TRANSCEND-CLL) Positive topline June 2021 2H 20212 Asset Timing Abecma Approval in 4L+ MM (KarMMa) Approved in U.S.1 & EU Zeposia Approval in UC (TRUENORTH) Approved in U.S. Positive CHMP Opinion iberdomide + dex Data to be presented at ASH 2021 deucravacitinib Psoriasis Ph3 POETYK PSO-2 (IM011-047) Positive topline Feb 2021 deucravacitinib Ph2 POC in UC (LATTICE-UC) PoC not established milvexian (FXIa inhib) Ph 2 POC in VTEp in TKR Data to be presented at AHA 2021 mavacamten Obstructive HCM (EXPLORER-HCM) U.S. PDUFA - January 28, 2022 MAA under review 1 Approved after 4 prior lines of therapy in U.S. 2 Expected in 2022


 
Q3 2021 Results Not for Product Promotional Use Hematology Fibrosis HSP47 LPA1 Antagonist Immunology Oncology Data as of October 27, 2021 Anti-Fucosyl GM1 Anti-OX40 TIGIT BispecificAnti-NKG2A Anti-SIRPα1 AR LDD Anti-CTLA-4 NF Anti-CCR8 Anti-CTLA-4 Probody BCMA TCE CD3xPSCA (GEMoaB)2 IL-12 Fc Anti-IL8 Anti-TIGIT BET Inhibitor (BMS-986158) CD19 NEX T BCMA ADC BCMA CAR T (bb21217) TGFβ Inhibitor LSD1 Inhibitor1 iberdomide 1 - In development for solid tumors and hematology; 2 - BMS has an exclusive option to license and/or option to acquire iberdomide MK2 InhibitorAnti-CD40 IL2-CD25 Imm. Tolerance (Anokion)2 cendakimab branebrutinib deucravacitinib Cardiovascular FA-RelaxinFXIa Inhibitor 18 Phase 1 Phase 2 Phase 3 A/I CELMoD (CC-92480) A/I CELMoD (CC-99282) 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) BET Inhibitor1 (CC-95775) NME FPR-2 Agonist Active Clinical Development Portfolio STING Agonist danicamtiv BCMA NEX T motolimod Cardiac Myosin Inhibitor milvexian (FXIa Inhibitor) mavacamten CD3xCD33 (GEMoaB)2 TYK2 Inhibitor TYK2 Inhibitor (Nimbus)2 GPRC5D CAR T COVID-19 SARS-CoV-2 mAb Duo Anti-CTLA-4 NF-Probody CK1α CELMoD ROMK Inhibitor BTK Inhibitor BCMA NKE ROR1 CAR T Anti-TIM3 farletuzumab - eribulin ADC FAAH/MGLL Dual Inhibitor relatlimab1 bempegal- desleukin linrodostat subcutaneous nivolumab eIF2b Activator pegbelfermin Marketed