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8-K - CURRENT REPORT - BRISTOL MYERS SQUIBB CObrhc10018812_8k.htm
 J.P. Morgan Healthcare Conference  January 11, 2021 
 

   Forward Looking Statement and Non-GAAP Financial Information  *  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. 
 

 A differentiated biopharma company focused on innovative medicines for patients with cancer and other serious diseases  BEST OF BIOTECHBEST OF PHARMA  Leading scientific innovationCollaborating at center of the biotech ecosystemLeveraging global scale and agilityDriven by the best people  *  Our strategic foundation 
 

   Strength of execution in 2020 provides foundation for future growth    *  Successful integration and synergy capture  Strong, high-performance organization  Commercial launch execution  Reblozyl ● Zeposia MS ● Onureg  Superior pipeline execution   Foundation in place for portfolio renewal  Future growth potential further enabled  Cashflow to invest in future innovation   Disciplined business development  Early pipeline strengthened & CV franchise renewal accelerated with MyoKardia  Zeposia UC ● deucravacitinib PsO ● Multiple positive trials for IO    Driving in-line growth  Maintaining leadership position in key disease areas  Opdivo 1L lung & LCM expansion opportunitiesContinued growth & favorable IP ruling for Eliquis            Strengthened IP position for Revlimid*  Not for Product Promotional Use  * Revlimid remains subject to patent litigation 
 

         A leading patient-focused biopharmaceutical company  *  Leading Products across Four Therapeutic Areas  Robust Early-stage Pipeline*  Across leading drug discovery platforms:Small moleculesProtein homeostasisBiologicsCell & gene therapy  Deep and BroadLate-stage Pipeline   8  *Phase I / II Assets  Recent/potential near-term new product launches  Financial strength enabling continued investment for growth  Solid Tumor Oncology  liso-cel  ide-cel  Deucravacitinib   Mavacamten  Additional expansion opportunities across multiple assets  >50 assets  Hematology  Cardiovascular  Immunology  2020 Total Revenues guidance   $41.5B - $42.0B  Free Cash Flow 2021-2023  $45B - $50B  Not for Product Promotional Use 
 

   Objectives for growth and portfolio renewal  Deliver top and bottom line growth through 2025  Diversified, earlier life-cycle growth products  Strong operating margins & cash generation  Grow the business  Renew the portfolio  Financial strength & flexibility  Maximizing our in-line business and launch portfolioContinuing to invest in our late-stage pipeline and expansion opportunitiesAdvancing our mid-stage pipelineDisciplined investment in additional growth though BD  Execution priorities  Continued high performance organization  *  Not for Product Promotional Use 
 

   Bristol Myers Squibb view broadly aligned Expect low to mid-single digit revenue CAGR,* as inline growth products and launches more than offset LOEsStronger conviction on launch product potentialLow double-digit revenue CAGRex-Revlimid & Pomalyst* Maintain strong profitability;low to mid 40s operating margin** Cashflow and balance sheet strength for continued business development    Growing our business from 2020-2025  *  Analyst consensus revenue estimates     LOEs = Revlimid, Pomalyst, Sprycel, Orencia, Abraxane  *At constant exchange rates - There is no reliable or reasonable estimable comparable GAAP metric for this forward-looking information** Non-GAAP - There is no reliable or reasonable estimable comparable GAAP metric for this forward-looking information  Primarily IO & Eliquis  CAGR of 3.7%  Continuing business              2020  LOEs  In-line Brands  Launches  2025  Not for Product Promotional Use 
 

           A strong base for continued portfolio renewal in 2025  *  Strong profitability  Growth opportunities for new launches through expansion into new indications  New launches & registrational opportunities from mid & late-stage pipeline  Continued investment in BD  LOE products = Revlimid, Pomalyst, Sprycel, Abraxane  Continuing business = In-line brands + launch portfolio   * Non-GAAP - There is no reliable or reasonable estimable comparable GAAP metric for this forward-looking information      Continuing business ~90% of companyLaunch portfolio ~30% of continuingbusiness  Refreshed projected business mix    OtherContinuingBusiness  Not for Product Promotional Use 
 

 Growth opportunities for the second half of the decade  $20B-$25B in NRA revenue potential* in 2029 Additional potential indications launching in 2025+  Launch portfolio growth potential  Mid to late-stage pipeline yields new launch opportunities  iberdomide  CC-92480  FXIa inhib  bempeg  Relatlimab  Cendakimab  CC-93269  Danicamtev  Continued innovation  Diverse internal pipeline with >20 assets with proof of concept decisions over next 2-3 yearsStrong R&D capabilitiesSignificant capital for Business Development opportunities e.g. MyoKardia  *  ** Non-GAAP - There is no reliable or reasonable estimable comparable GAAP metric for this forward-looking information  * Peak non-risk adjusted revenue potential; subject to positive registrational trials and health authority approval    2025 projected mix  Not for Product Promotional Use 
 

     Deucravacitinib (TYK2i)  Psoriasis: 1st Ph3 psoriasis data in-house w/ 2nd Ph3 read-out expected in Q1’21   Ph3 PsA to initiate this yearPh2s ongoing in IBD and lupus, 1st expected 2H21      Launched in TD beta-thal & post-ESA RS+ MDS  Ph3 ESA-naïve MDS (COMMANDS) expected 2022+Ph3 MF to initiate this year     Mavacamten  U.S. submission for obstructive HCM planned Q1 2021  Non-obstructive HCM: plans to initiate Ph2/3HFpEF: Ph2 initiating    Cell Therapy Franchise  Liso-cel: under FDA review for 3L+ LBCLIde-cel: PDUFA March 27, 2021 in 4L+ MM  2L TE & TNE DLBCL expected 2021, 3L+ CLL expected 2022Ph3 KarMMa3 3L-5L MM expected 2022+      Launched in U.S. & EU for RMSPositive Ph3 data in UC  Expect FDA approval for UC in 2021Ph3 Crohn’s data expected 2022+      Launched in 1L AML maintenance        Launched in myelofibrosis    Launch portfolio with $20B-$25B of non-risk adjusted revenue replacement power  At least$4B  At least$3B  At least$1B  Non-risk adjustedRevenue potential*  Current status  Additional key growth opportunities  <$1B  *Peak non-risk adjusted revenue potential through 2029; subject to positive registrational trials and health authority approval    *  Not for Product Promotional Use 
 

 Deucravacitinib (TYK-2i): Potential broad autoimmune therapy  *  POETYK-2 Q1'21  Beginning Ph3 in 2021  Ph2 PoC 2H’21  Ph2 PoC 2022  Ph2 PoC 2H’21  Ph2 PoC 2022+  Key expansion opportunities  Deucravacitinib has the potential to address a broad spectrum of auto-immune diseases    2029 non risk-adjusted sales potential* >$4B  SLE   Lupus Nephritis  Ulcerative Colitis   Crohn's Disease   Psoriatic Arthritis  P1  P2  P3  Psoriasis  Timing  # Treated Pts with moderate-severe disease:  Patient #s in millions**  *Peak non-risk adjusted revenue potential through 2029; subject to positive registrational trials and health authority approval** Numbers indicate patients on any prescribed treatment (systemic, topical, advanced)Source: Decision Resources Group; BMS Internal Analysis     2.5M  1.0M  0.4M  0.8M  0.8M  Not for Product Promotional Use 
 

 Reblozyl: Differentiated medicine for anemia  *  Patient #s in thousands**  1L MDS (COMMANDS)  P1  Myelofibrosis (INDEPENDENCE)  P2  P3  Topline 2022+  Ph3 to begin Q1’21  1 Addt’l MDS with COMMANDS (Incremental to MEDALIST)2 Current MDS indication3 Current Beta thal indication  *Peak non-risk adjusted revenue potential through 2029; subject to positive registrational trials and health authority approval**Represent diagnosed prevalence estimates for Reblozyl Eligible patient population (to current or future expected label)Source: Decision Resources Group; BMS Internal Analysis     2029 non risk-adjusted sales potential* >$4B  Key expansion opportunities  41K  14K  7K  12K  (ESA-naïve)1  (ESA-failure,RS+)2  Not for Product Promotional Use 
 

 Mavacamten: Expanding our CV franchise  Obstructive HCMSignificant unmet need for patients with symptomatic obstructive HCMCurrent options limited to treatment of symptoms e.g. use of beta blockers or highly invasive proceduresA potential first-in-class medicine to potentially address the underlying disease    Obstructive HCM (completed)  P1  Non-obstructive HCM  Precision diastolic disease (HFpEF)  P2  P3  * Assumes 25% diagnosis rate  ** Peak non-risk adjusted revenue potential through 2029; subject to positive registrational trials and health authority approval  *    2029 non risk-adjusted sales potential* >$4B  Key expansion opportunities  Application to be filed in Q1’21Ph2 Maverick study completed; plans to initiate Ph2/3Ph2 POC EMBARK initiating  433K  160-200K  Diagnosed* symptomatic oHCM:    2/3 obstructive  U.S.    80-100  Patient #s (in thousands)  EU5    80-100  Not for Product Promotional Use 
 

 Factor XIa inhibitor: Potential to expand antithrombotic therapy and further renew our CV franchise  *  Key upcoming Ph2 Proof-of-Concept readouts   FXIa-i vs enoxaparinExpected 2021  FXIa-i + clopidogrel + aspirin vs. clopidogrel + aspirin Expected 2022  P1  P2  Total knee replacement (VTE)  Secondary stroke prevention  P3  Potential opportunity to address unmet needs due to bleeding riskUp to 20% of patients with high stroke risk do not receive treatmentCombining OACs with dual-antiplatelet therapy is limited due to risk of serious bleeding  FXIa has potential to deliver efficacy with less bleedingPotentially supports prevention of thromboembolic events with:reduced risk of serious bleedingability to combine with anti-plateletsEncouraging genetic, epi and preclinical data  Not for Product Promotional Use 
 

 CELMoD agents: Unique opportunity to sustain a leadership position in multiple myeloma  Potential to displace IMiD* agents as new foundation  Unlock the potential of BCMA targeting  Redefine SoC across lines of therapy  BCMA Targeting Agents  CELMoD agents  Combinations      Unique potential to create novel combinations with BCMA-targeting agents  ORR 2021 (potentially registrational)Initiating earlier lines in MM in 2021ORR 2022  Two different assets in late-stage development  iberdomide + dexamethasone  P1  iberdomide triplet  CC-92480  P2  P3    *  Iberdomide and CC-92480 Potential to improve on IMiD agentsClinical data show promising, durable response rates in highly refractory patientsTrials assessing doublet and triplet treatment options underway    * IMiD agents are a subgroup of CELMoD agents with a similar MOA  Not for Product Promotional Use 
 

 Well positioned for long-term innovation   Protein Homeostasis  *  Cell Therapy  Immuno-oncology  Human Genetics   Broad network of external partnerships  Opportunity to be industry leaders across key scientific platforms      Robust and diverse early pipeline  Oncology21 Phase I / II assets  Immunology10 Phase I / II assets  Cardiovascular6 Phase I / II  Hematology16 Phase I / II assets  Fibrosis6 Phase I / II assets  Neuroscience1 Phase II asset  >50 assets across leading drug discovery platforms>20 POC decisionsin the next 2-3 years  Not for Product Promotional Use 
 

 Significant financial flexibility to support a balanced approach to capital allocation  *  ~$22B* cash on-hand as of Q3 2020  *Cash includes cash, cash equivalents and marketable securities; 75% of total cash is in the U.S.**Future dividend payouts illustrated using 2020 dividend rate and requires board authorization  Returning capital to shareholders:Continued dividend growth$2B incremental share repurchase in 2021; $3B - $4B total planned  Further strengthen the balance sheet to enable future investment<1.5x debt to EBITDA by 2024Maintain strong investment-grade credit ratingBring forward up to $4B additional debt reduction in 2021  Future innovation through business development  ~$45B - $50BFCF expected 2021-2023  Not for Product Promotional Use 
 

 Significant capacity for business development Consistent criteria for sourcing external innovation:Focused on therapeutic areas of interest Oncology ● Hematology ● Immunology ● Cardiovascular ● Neurology  Business Development is a top priority  *  Further strengthen the company’s growth profile andsupport pipeline & research sustainability  ScientificallySound  Strategically Aligned  FinanciallyAttractive  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  liso-cel  3L+ DLBCL U.S./EU approval    2L TE and TNE DLBCL     3L+ CLL   ide-cel  4L+ MM U.S./EU approval  iberdomide + dex  4L+ MM Ph 1b/2a  Deucravacitinb  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 & approval  Opdivo (+/- Yervoy)  Metastatic1L HCC (CM-9DW)1L MSI-H CRC (CM-8HW)    AdjuvantNeo-adj Lung EFS (CM-816)Peri-adj Lung (CM-77T)  Bempeg  1L melanoma*** & 1L renal   liso-cel  3L+ Follicular lymphoma  ide-cel  3L+ MM (KarMMa-3) Ph3    2L+ MM (KarMMa-2) POC  CC-92480  4L+ MM Ph1/2  CC-93269 (TCE)  Initiation of pivotal trial  Deucravacitinb  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  *  2021 Key Milestones  Execution Scorecard    2020-2025:Low to mid-single digit CAGR*Low double-digit 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  *at constant exchange rates - There is no reliable or reasonable estimable comparable GAAP metric for this forward-looking information **Non-GAAP - There is no reliable or reasonable estimable comparable GAAP metric for this forward-looking information ***expected in 2022  To be expanded to include regulatory milestones pending future registrational successes  Not for Product Promotional Use 
 

 Established a strong foundation in 2020Leading in-line medicines, significant short term launch opportunities,and a rich pipeline in each therapeutic area of focusExpect to deliver low to mid-single digit revenue CAGR from 2020 to 2025Strong profitability and financial flexibility enables continued investment in innovationWell positioned for the second half of the decade  *    Bristol Myers Squibb is a leading Biopharma company focused on Innovation and well positioned for growth  Not for Product Promotional Use