4 th Quarter 2017 Earnings Review & Investor Update
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1 4 th Quarter 2017 Earnings Review & Investor Update February 5,
2 Forward-Looking 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 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 from the SEC, 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 also contains certain non-gaap financial measures, adjusted to include certain costs, expenses, gains and losses and other specified items. Reconciliations of these non-gaap financial measures to the most comparable GAAP measures are available on the company s website at 2
3 Giovanni Caforio Chairman & Chief Executive Officer 3
4 Overview Exciting Announcement in 1L NSCLC Strong Q4 and FY 2017 Continued revenue and earnings growth in 2018 Robust long-term growth outlook 4
5 Tom Lynch Chief Scientific Officer 5
6 Met Co-Primary endpoint of PFS in High TMB Important result for 1L NSCLC Patients: Highly statistically significant Benefit independent of PD-L1 status Demonstrates strength and importance of Translational Research capabilities Further validates role of CTLA-4: Third tumor where benefit demonstrated for Opdivo+Yervoy 6
7 Hypothesized TMB Mechanism TMB is amount of somatic mutations in the tumor DNA relative to healthy tissue Tumor cells with high TMB 1,2 1,2 2-5 may express neo-antigens that could make them more visible to the immune system The high immunogenicity of tumors with high mutation burden makes them a rational target for treatment with I-O therapies 1,2 1. Schumacher TN, Schreiber RD. Science. 2015;348(6230): Kim JM, Chen DS. Ann Oncol. 2016;27(8): Liontos M et al. Ann Transl Med. 2016; 4(14): Sharma P, Allison JP. Science. 2015;348(6230): Giannakis M et al. Cell Rep. 2016;15:
8 Today s Announcement is Focused on the Co-Primary Endpoints for Part 1 of CM-227 1L NSCLC ~1200 pts PD-L1 Expressors ( 1%) ~500 pts PD-L1 Non Expressors (<1%) Part 1 Opdivo 3 Q2W Yervoy 1 Q6W Opdivo Mono Chemo Doublet Opdivo 3 Q2W Yervoy 1 Q6W Opdivo + Chemo Doublet Chemo Doublet Part 1a Part 1b Part 1 Chemo doublet options include: NSQ: pem/cis, pem/carbo; SQ: gem/cis, gem/carbo. ~750 pts 1L NSCLC Part 2: Opdivo + Chemo Doublet Chemo Doublet Fully Enrolled since October 2017 Part 2 Chemo doublet options include NSQ: pem/carbo, pem/cis; SQ: carbo/taxol. 8
9 Integrated Analysis Plan Across Part 1 1L NSCLC PD-L1 Expressors ( 1%) PD-L1 Non Expressors (<1%) Opdivo 3 Q2W Yervoy 1 Q6W Opdivo Mono Chemo Doublet Opdivo 3 Q2W Yervoy 1 Q6W Opdivo + Chemo Doublet Chemo Doublet Part 1a Part 1b Part 1 Opdivo 3 Q2W Yervoy 1 Q6W Chemo Doublet Part 1 Chemo doublet options include: NSQ: pem/cis, pem/carbo; SQ: gem/cis, gem/carbo. 9
10 Two Co-Primary Endpoints Across Part 1 Opdivo/Yervoy vs Chemo for PFS in TMB selected OS in PD-L1 selected 10
11 Met Co-Primary of PFS in High-TMB Pooled Part 1 Opdivo 3 Q2W Yervoy 1 Q6W Chemo Doublet TMB High Opdivo 3 Q2W Yervoy 1 Q6W Chemo Doublet PFS High-TMB: >10mt/MB ~45% of Assessed Patients 11
12 CM-227 Result Validates TMB as an Important New Marker Clinical Trials with TMB Analysis Opdivo & Yervoy Next Generation Assets TMB is being studied prospectively in multiple tumor types and programs 12
13 Broad 1L NSCLC Program Trial Status* CM-227 (Part 1a) Opdivo + Yervoy Final OS in PD-L1 pts Late 2018/Early 2019 CM-227 (Part 2) Opdivo + Chemo 2019 CM-9LA Opdivo + Yervoy + Chemo (2 cycles) Opdivo + IDO (BMY and INCY) 2H2019 Initiating *Timing is event-driven 13
14 Significant Clinical & Regulatory Milestones Tumor Expected Timing* RCC CM-214 Opdivo + Yervoy (1L) PDUFA, 4/18 HCC CM-459 Opdivo (1L) 2H 2018 Gastric CM-649 Opdivo+ Yervoy or Chemo (1L) 2019 Head & Neck CM-651 Opdivo + Yervoy (1L) 2019 CM-714 Opdivo + Yervoy (1L Cis Inel) 1H 2019 ** CM-331 Opdivo (2L) 1H 2018 SCLC Company CM-451 Sponsored Opdivo +/- Yervoy (1L Maintenance) 2H 2018 Trials Melanoma CM-238 Opdivo (Adjuvant) Approved Pan Tumor Opdivo US Q4W Dosing PDUFA, 3/18 * Estimated timing (except PDUFA dates) as noted on clinicaltrials.gov ** Update to clinicaltrials.gov pending 14
15 Giovanni Caforio Chairman & Chief Executive Officer 15
16 2017 Year-End Results $20.8 Billion in Sales $4.9 B $4.9 B 46% * 31% * 7% Growth* $1.2 B 18% * $2.5 B 9% * $2 B 10% * * vs Full Year
17 Strong Foundation for Growth 2018 and Beyond Eliquis poised for significant growth Multiple $1B+ potential growth opportunities from Opdivo including: Lung RCC HCC Gastric Innovative pipeline with advancing registrational opportunities Considerable margin expansion potential and financial flexibility 17
18 Operating Model Evolution Faster Decision-Making Increased Efficiency & Agility Disciplined Resource Allocation Delivering on our priorities Prioritize key brands & markets Simpler, more competitive approach to R&D Realign manufacturing network for biologics-rich portfolio Streamline G&A to be more strategically aligned to our business Evolve our culture to align with the company we want to be 18
19 Charlie Bancroft Chief Financial Officer 19
20 Strong Performance REVENUE GROWTH Q4 FY % 7% EPS GROWTH 2016 $ % 2017 $3.01 All results presented on a Non-GAAP Basis 20
21 Primary P&L Drivers Q (non-gaap) Gross Margin Product Mix SG&A Operating Model Efficiencies R&D Continued Pipeline Investment Tax Rate Earnings Mix 21
22 Balanced Approach to Capital Allocation Business Development Remains a Top Priority Dividend Commitment 9th Consecutive Annual Increase Opportunistic Share Repurchases ~$2.5B in
23 2018 Guidance (non-gaap) EPS $3.15 $3.30 Revenue Increasing Low-Mid Single Digits Gross Margin Approximately 70% MS&A R&D Decreasing Low-Mid Single Digits Increasing High Single Digits Tax Rate 20%-21% 2017 baseline for MS&A and R&D as restated 23
24 4 th Quarter 2017 Earnings Review & Investor Update February 5,
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