Transforming Pharma to Deliver Sustainable Long-Term Growth /// March 10-11, 2021 Cautionary Statements Regarding Forward-Looking Information
Total Page:16
File Type:pdf, Size:1020Kb
Transforming Pharma to Deliver Sustainable Long- term Growth /////////// Capital Markets Day March 10-11, 2021 Stefan Oelrich President of the Pharmaceuticals Division Marianne De Backer Head of Strategy and BD&L Pharmaceuticals Christian Rommel Head of R&D Pharmaceuticals 1 /// Bay er Capital Markets Day /// Transforming Pharma to Deliver Sustainable Long-term Growth /// March 10-11, 2021 Cautionary Statements Regarding Forward-Looking Information This presentation may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at http://www.bayer.com/. The company assumes no liability whatsoever to update these forward-looking statements or to conformthem to future events or developments. 2 /// Bay er Capital Markets Day /// Transforming Pharma to Deliver Sustainable Long-term Growth /// March 10-11, 2021 1 Overview Pharma: Focused on Therapeutic Areas with High Unmet Needs Sales development EBITDA margin development Sales by region In €m In %, before special items In %, in 2020 17,962 16,420 16,847 16,746 17,243 North 34.9 America 22 33.9 33.4 32.0 32.6 40 EMEA Latin 5 America 33 2016 2017 2018 2019 2020 2016 2017 2018 2019 2020 Asia / Pacific Therapeutic areas Leading positions in key therapeutic areas Top products In %, based on sales 2020 In €m, based on sales 2020 Cardiovascular Other 4,515 Hematology 10 Hematology 5 2,468 Cardiovascular 37 Retinal Diseases Ophthalmology 14 1,081 9 Women´s Health Oncology 851 9 16 Radiology Radiology Women´s Health 670 3 /// Bay er Capital Markets Day /// Transforming Pharma to Deliver Sustainable Long-term Growth /// March 10-11, 2021 2 Pharma Mark et We are Operating in a Rapidly Changing but Attractive Market Environment Pharma Market Market Dynamics Market Size 20201 Opportunities Japan • Rising life expectancy and increased access to China healthcare systems 7% APAC 8% • Accelerated digital transformation across the 9% value chain • Technological disruption by breakthrough science ~ €1,000bn 52% Americas • Shift from treatment to prevention and potential 24% cure EMEA Challenges Market CAGR 2020-24e2 • Pressure on pricing • Declining R&D productivity 4 - 5% • Increased pressure for value and real-world evidence 1 Source: IQVIA MIDAS MAT Q3-20 2 Source: IQVIA Market Prognosis as of September 2020 4 /// Bay er Capital Markets Day /// Transforming Pharma to Deliver Sustainable Long-term Growth /// March 10-11, 2021 3 Strategy The Transformation of Pharma is Underway New management team focused on improving existing structures and processes Realize full potential of products and pipeline to mitigate LoE impact and return to growth Re-allocate resources and shape financial profile to post LoE future Capitalize and build on investments in breakthrough innovation, espec. C> Challenge strategic direction of R&D - enhance focus on external innovation 5 /// Bay er Capital Markets Day /// Transforming Pharma to Deliver Sustainable Long-term Growth /// March 10-11, 2021 3 Strategy Our Transformation is Guided by Five Strategic Focus Areas Strategic Focus Areas Portfolio and Digital Health Cell & Gene Oncology China & US Pipeline Therapy Key Priorities Maximize the value of the current portfolio and manage the loss of exclusivity for Xarelto & Eylea Deliver three new potential blockbusters from late-stage pipeline Build digital health solutions and capitalize on Cell & Gene therapy platform Build an at scale player in oncology in our areas of focus Evolve regional strategies in China and the US to sustain future growth 6 /// Bay er Capital Markets Day /// Transforming Pharma to Deliver Sustainable Long-term Growth /// March 10-11, 2021 4 Xarelto & Eylea Xarelto and Eylea are on Track to Deliver Peak Sales Potential Xarelto Eylea €bn €bn 2.5 2.5 4.5 4.1 2.2 3.6 1.9 3.3 2.9 1.6 2016 2017 2018 2019 2020 2016 2017 2018 2019 2020 • Peak sales potential > €5bn • Peak sales potential > €2.5bn • Strongest real-world experience • Leveraging leading market position in retinal diseases • Most comprehensively licensed NOAC • Investigating high-dose formulation • Near-term impact due to Covid-19 7 /// Bay er Capital Markets Day /// Transforming Pharma to Deliver Sustainable Long-term Growth /// March 10-11, 2021 4 Xarelto & Eylea Xarelto´s Loss of Exclusivity Will be Staggered Over Several Years Xarelto´s main patent expirations Xarelto sales by main markets Effective Region Patent USA Duration Other regions China Compound patent 2020 12% 11% Japan Compound patent 2022-2025 Germany Japan 11% Europe Compound patent Q1 2024 11% incl. 6 months pediatric FY 2020 exclusivity 5% France €4.5bn USA Compound patent Q1 2025 11% 6% China incl. 6 months pediatric UK exclusivity Once-daily use patent 2027* 33% Other EMEA *) Litigation settled with all 16 generic defendants. Terms are confidential. As reported for Q3 2020, Unichemis licensed to market a generic version of Xarelto 10/15/20mg beginning in 2027. Official patent expiration in 2034. 8 /// Bay er Capital Markets Day /// Transforming Pharma to Deliver Sustainable Long-term Growth /// March 10-11, 2021 4 Xarelto & Eylea Historic Genericization Patterns of Small Molecules Reveal that the most Pronounced LoE Impact Occurs in the US Standard Units Atorvastatin (Lipitor™) Standard Units Clopidogrel (Plavix™) Valsartan (Diovan™) Standard Units 120% 120% 120% 100% 100% 100% 80% 80% 80% 60% 60% 60% 40% 40% 40% 20% 20% 20% 0% 0% 0% Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year Year 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 0 1 2 3 4 5 6 7 8 9 10 • Post LoE, in EU5 and Latin America sales decrease moderately over time while in the US, sales are declining rapidly • Staggered market entry of generics in many European countries • Most Emerging Markets are characterized by private and tender business, reducing relevance of patent expirations Source: IQVIA Data; Standard Unit Volume set to 100% in the year of patent expiration Lipitor, Plavix and Diovan are trademarks of Pfizer, Sanofi and Novartis respectively 9 /// Bay er Capital Markets Day /// Transforming Pharma to Deliver Sustainable Long-term Growth /// March 10-11, 2021 4 Xarelto & Eylea Bayer´s Long-Term Sales Projection Reveals Limited LoE Impact and Return to Sustainable Long-term Growth Value maximization Xarelto LoE Return to sustainable growth Trough 2020 expectedin Sales: €17.2bn Bayer Pharma 2024 Sales Projection Margin1: 35% Market Estimate2 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 1 EBITDA margin before special items 2 Consolidated estimates from seven major banks as of Jan. 2021 Graphic illustrative 10 /// Bay er Capital Markets Day /// Transforming Pharma to Deliver Sustainable Long-term Growth /// March 10-11, 2021 5 Growth Drivers We Laid The Foundation for Long-term Growth at Pharma Main Building Blocks of Post LoE Growth 1 Late-stage Pipeline Finerenone Elinzanetant in CV & WH (KaNDy NT-814) Oncology Pipeline eg. EGFRexon20 inhib., ATR inhib., TTCs C> platform expected to deliver Cell & Gene Therapy significant sales contributions from Platform ~2025 onwards External Innovation >25 BD&L-transactions signed in 2020 and BD&L Enhanced focus on external innovation to replenish pipeline 1 In collaboration with Merck & Co. Inc., Kenilworth, NJ, USA 11 /// Bay er Capital Markets Day /// Transforming Pharma to Deliver Sustainable Long-term Growth /// March 10-11, 2021 Christian Rommel Head of Pharma R&D 12 /// Bay er Capital Markets Day /// Transforming Pharma to Deliver Sustainable Long-term Growth /// March 10-11, 2021 6 R&D A Successfully Matured Late-stage Pipeline May Deliver Three New Potential Blockbusters Nubeqa (Darolutamide)1 Finerenone Elinzanetant AR-Antagonist MR-Antagonist Dual NK 1,3 Receptor-Antagonist • Launched in nmCRPC - global roll- • Significant reduction of renal and • First-in-class oral, non- out underway cardiovascular outcomes in hormonal, once-daily • Differentiated clinical profile - 31% patients with CKD and T2D neurokinin-1,3 receptor OS benefit & favourable safety • Filed in key markets - FDA priority antagonist profile (ARAMIS) review • Promising phase IIb data for the • Prim. completion of phase III trial in • Phase III trials in CKD/T2D treatment of frequent mHSPC with chemo mid-2021e (FIGARO) and in HFm/pEF menopausal symptoms (ARASENS) (FINEARTS-HF) ongoing • Phase III to be initiated in 2021 • New phase III trial in mHSPC • Peak sales potential ≥€1bn • Peak sales potential >€1bn without chemo (ARANOTE) • Peak sales potential ≥€1bn 1 In collaboration with Orion Corporation 13 /// Bay er Capital Markets Day /// Transforming Pharma to Deliver Sustainable Long-term Growth /// March 10-11, 2021 6 R&D Peak-sales Potential of Key Late-stage Pipeline Assets 2018 2021 Peak Sales New: Peak Sales Pipeline Asset Pipeline Asset Potential Elinzanetant Potential Nubeqa1 ≥ €1bn (KaNDy NT-814) Nubeqa1 ≥ €1bn (Darolutamide) (Darolutamide) Finerenone ≥ €1bn Finerenone ≥ €1bn Vitrakvi > €750m Elinzanetant > €1bn (Larotrectinib) (KaNDy NT-814) Aliqopa ≥ €0.5bn (Copanlisib) Launched: Verquvo2 ~ €0.5bn Vitrakvi (Vericiguat) Aliqopa Verquvo2 (Vericiguat) 1 In collaboration with