Attached files
| file | filename |
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| EX-99.2 - CERTAIN SUPPLEMENTAL INFORMATION - BRISTOL MYERS SQUIBB CO | q12021ex992.htm |
| EX-99.1 - PRESS RELEASE OF BRISTOL-MYERS SQUIBB COMPANY DATED APRIL 29, 2021 - BRISTOL MYERS SQUIBB CO | q12021ex991.htm |
| 8-K - 8-K - BRISTOL MYERS SQUIBB CO | bmy-20210429.htm |
Q1 2021 Results April 29, 2021
Q1 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 Q1 2021 Results Giovanni Caforio Board Chair and Chief Executive Officer 3
Q1 2021 Results Not for Product Promotional Use Operational Performance Strong commercial execution • Sales of $11.1B in Q1; increase of 3% YoY, +8% excl. Q1’20 COVID-related buying patterns • Continued execution on launches for I-O and new product portfolio Financial Strength Strong financial results and outlook • Continued revenue and EPS growth • Affirm 2021 Non-GAAP guidance • Balance sheet strength and strong cashflow generation; accelerated debt repayments of ~$4B & executed share repurchases of ~$1.8B in Q1 Pipeline Execution Significant milestones • Solid Tumors: Opdivo positive data in 1L ESCC (CM-648); relatlimab positive data in 1L melanoma FDC w/Opdivo; & Opdivo approval in 1L gastric (CM-649) • Hematology: approval of Breyanzi in R/R LBCL & Abecma in RRMM • Immunology: presented deucrava results from POETYK-1 & POETYK-2 in PsO • CV: mavacamten filed by U.S. FDA in obstructive HCM (PDUFA: Jan 28, 2022) Q1 2021 Performance 4
Q1 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 approval 2L TE and TNE DLBCL 3L+ CLL Abecma 4L+ MM U.S./EU approval1 Iberdomide + dex 4L+ MM Ph 1b/2a Deucravacitinib PsO (2nd study) Ph3 U.S. filing UC Ph2 (POC) Zeposia UC U.S. approval (PDUFA: May 30) / 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 - 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
Q1 2021 Results Not for Product Promotional Use Continued portfolio renewal into 2H of decade 6 *Loss of Exclusivity (LOE) products are Revlimid, Pomalyst, Sprycel, and Abraxane **Non-risk adjusted revenue potential; subject to positive registrational trials and health authority approval 2025 projected business mix Launch portfolio ~30% of continuing business Continuing business ~90% of company • $20B-$25B in NRA revenue potential** in 2029 • Additional potential indications launching in 2025+ Current Launch Portfolio Other continuing business Continuing business LOE products* Launch portfolio growth potential • Additional mid-to late- stage pipeline • Diverse early-stage pipeline • Balance Sheet strength for additional BD opportunities Future Growth Opportunities
Not for Product Promotional Use David Elkins Chief Financial Officer 7 Q1 2021 Results
Q1 2021 Results Not for Product Promotional Use Net Sales $ in Billions Vs. Prior Year $2.9 1% $2.9 9% $1.7 3% $0.8 6% Performance in key products Net Sales $ in Billions Vs. Prior Year $0.8 8% $0.5 10% $0.5 15% $0.3 5% 8 ▲ ▲ ▲ ▲ ▲ ▲ *approx. $500M in Q1’20 + 8% excl. COVID-related buying patterns* + 6% excluding COVID* & FX Q1 2021 Total Sales: $11.1B, up 3%
Q1 2021 Results Not for Product Promotional Use US: Continued significant demand growth • Q1 sales up 8% vs. PY • Continued strong underlying demand, one- time Medicare coverage gap true-up ~$160M • ~11% TRx growth Q1 2021 Eliquis performance 9Rx Source: Symphony Health Significant future growth opportunity • Continues to be the best-in-class drug in an expanding category International: Sales increased 11% • Continues to be #1 NOAC in key markets with future growth Global net sales up 9% in Q1 47% 54% 25% 21% 26% 24% Q1 2020 Q1 2021 TRx Share - US Other NOACs Warfarin Eliquis 57% 62% 16% 12% 26% 25% Q1 2020 Q1 2021 NBRx Share – US
Q1 2021 Results Not for Product Promotional Use U.S. • 1L Lung* shares in low double-digits • Strengthened position in 1L Renal with O+Cabo International • Strong adoption in new launches offset by impacts of COVID and 2L I-O eligibility Q1 2021 Opdivo performance 10 24% 24%30% 22% Approx. U.S. Sales Mix Note: percentages approximate based on tumor ranges 28% 24% 27% 21% Approx. Ex-U.S. Sales Mix NSCLC RCC Melanoma All others Near term growth drivers • 2021 return to growth supported by • 1L Lung & 1L Renal (CM-9ER) • Recent U.S. approval in 1L Gastric (CM-649) • Potential launches: adjuvant EC (CM-577) & adjuvant MIBC (CM-274) • Positive read-out: 1L ESCC (CM-648) *excluding EGFR/ALK patients
Q1 2021 Results Not for Product Promotional Use Q1 2021 Multiple Myeloma performance 11 $489 $512 $224 $261 Q1 2020 Q1 2021 Global sales growth of 1% • US: Reversal of inventory build offset growth • International: +4% driven by FX & demand, offset by ~$100M inventory build and PY tender Global sales growth of 8% • Continued demand growth from new triplet regimens and use in earlier lines Global Net Sales $1,966 $1,958 $949 $986 Q1 2020 Q1 2021 US Ex-US
Q1 2021 Results Not for Product Promotional Use • Encouraged by uptake in new patient starts • Continued transition from initial bolus to underlying demand • Remain focused on new patients earlier in their treatment journey • Expansion in global markets Advancing new product launches 12 • Continued traction as S1P modulator of choice in MS • Acceleration of Rx to commercial demand • Anticipate U.S. UC approval (PDUFA May 30th) and MAA under review • Positive physician feedback and awareness • Establishing profile in 1L maintenance setting in AML • Positive CHMP opinion $96 $115 $112 $2 $9 $18 $3 $14 $15 Q3 2020 Q4 2020 Q1 2021 Q1 2021 Global Net Sales $145M Reblozyl Zeposia Onureg
Q1 2021 Results Not for Product Promotional Use Cell Therapy Franchise • Best-in-class CD-19 CAR T • High physician awareness and robust feedback around efficacy and outpatient utilization • Rapid activation of ~55 sites with patients apheresed and recently infused • First-in-class BCMA CAR T • Enthusiasm from physicians with high awareness • Competitive position with two differentiated cell therapies to leverage site footprint and rapid activation — 40+ sites activated 13 Approved Feb 5, 2021 Approved March 26, 2021 Expand site footprint through continued account activation Maximize differentiated profiles Ensure seamless customer experience Priorities for 2021
Q1 2021 Results Not for Product Promotional Use US GAAP Non-GAAP $ in billions, except EPS Q1 2021 Q1 2020 Q1 2021 Q1 2020 Total Revenues, net 11.1 10.8 11.1 10.8 Gross Margin % 74.3% 66.0% 78.1% 79.4% MS&A 1.7 1.6 1.7 1.6 R&D 2.2 2.4 2.2 2.3 Effective Tax Rate 19.8% (152.0)% 16.8% 16.0% Diluted EPS 0.89 (0.34) 1.74 1.72 Diluted Shares Outstanding (# in millions) 2,265 2,258 2,265 2,298 Q1 2021 Financial Performance 14
Q1 2021 Results Not for Product Promotional Use Significant financial flexibility to support a balanced approach to capital allocation 15 $B Q1 2021 Total Cash** $13.2B Total Debt $46.3B Net Debt Position $33.1B *Subject to Board approval **Cash includes cash, cash equivalents and marketable securities Committed to reducing debt • Executed ~$4B debt reduction transaction • Maintain strong investment-grade credit ratings Returning capital to shareholders • Continued dividend growth* • $3B - $4B total share repurchase planned in 2021 • ~$1.8B executed in Q1 Future innovation through business development • Strategically Aligned • Scientifically Sound • Financially Attractive
Q1 2021 Results Not for Product Promotional Use 2021 Guidance 16 GAAP Non-GAAP Feb (prior) Apr (revised) Affirmed Net Sales High single-digit increase Unchanged High single-digit increase Gross Margin % ~80.5% ~79% ~80.5% MS&A Expense In line with 2020 Unchanged Low single-digit increase R&D Expense High single-digit decrease Low double-digit decrease Mid single-digit increase Tax Rate ~22% Unchanged ~16% Diluted EPS $3.12-3.32 $3.18-3.38 $7.35 - $7.55
Q1 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 17 Chris Boerner, Ph.D. Executive VP, Chief Commercialization Officer Samit Hirawat, M.D. Executive VP, Chief Medical Officer, Global Drug Development
Q1 2021 Results Not for Product Promotional Use 2021 News Flow 18 Asset Timing Opdivo Approval in 1L renal (CM-9ER) Approved Opdivo Approval in 1L gastric (CM-649) Approved Opdivo Approval in adjuvant esophageal (CM-577) PDUFA date May 20, 2021 Opdivo Approval in adjuvant MIBC (CM-274) 2H 2021 Opdivo CM-648 in 1L esophageal Positive topline April 2021 Relatlimab + Opdivo vs Opdivo mono 1L Melanoma CA224-047 Positive topline March 2021 Breyanzi Approval in 3L+ LBCL Approved in U.S. EMA Review Breyanzi 2L DLBCL 3L+ CLL 2H 2021 Asset Timing Abecma Approval in 4L+ MM1 Approved in U.S. EMA Review Zeposia Approval in UC PDUFA date May 30, 2021 iberdomide + dex 2H 2021 deucravacitinib Psoriasis Ph3 POETYK PSO-2 (IM011-047) Positive topline Feb 2021 deucravacitinib Ph2 POC in UC 2H 2021 milvexian (FXIa inhib) POC in VTEp for total knee replacement 2H 20212 mavacamten Obstructive HCM U.S. filing acceptance PDUFA date January 28, 2022 1 Approved after 4 prior lines of therapy 2 August 4th, 2021 per clinicaltrials.gov, study conducted by Janssen
Q1 2021 Results Not for Product Promotional Use Hematology Fibrosis pegbelfermin HSP47 LPA1 Antagonist JNK Inhibitor Immunology Oncology Data as of April 27, 2021 Anti-Fucosyl GM1 Anti-OX40 STING Agonist Anti-NKG2A Anti-SIRPα* CCR2/5 Dual Antagonist Anti-TIM3 Anti-CTLA-4 NF Anti-CCR8 Anti-CTLA-4 Probody BCMA TCE AR-LDD CD3xPSCA (GEMoaB)** Anti-IL8 Anti-TIGIT relatlimab* bempegal- desleukin linrodostat BET Inhibitor (BMS-986158) CD19 NEX T BCMA ADC BCMA CAR T (bb21217) TGFβ Inhibitor LSD1 Inhibitor* iberdomide *In development for solid tumors and hematology **BMS has an exclusive option to license and/or option to acquire iberdomide MK2 InhibitorAnti-CD40 IL2-CD25 Imm. Tolerance (Anokion)** IL2 Mutein cendakimab branebrutinib deucravacitinib Cardiovascular FA-Relaxin FXIa Inhibitor 19 Phase 1 Phase 2 Phase 3 A/I CELMoD (CC-92480) A/I CELMoD (CC-99282) GSPT1 CELMoD (CC-90009) BET Inhibitor* (CC-90010) CD33 NKE CD47xCD20 Neuroscience BTK Inhibitor AHR Antagonist (Ikena)** S1PR1 Modulator TLR 7/8 Inhibitor CD22 ADC (TriPhase)** BET Inhibitor* (CC-95775) NME FPR-2 Agonist Active Clinical Development Portfolio motolimod NLRP3 Agonist danicamtiv BCMA NEX T IL-12 Fc MYK-224 milvexian (FXIa Inhibitor) mavacamten CD3x33 (GEMoaB)** TYK2 Inhibitor TYK2 Inhibitor (Nimbus)** GPRC5D CAR T COVID-19 SARS-CoV-2 mAb Duo Anti-CTLA-4 NF-Probody CK1α Degrader ROMK Inhibitor FAAH/MGLL Dual Inhibitor * Marketed