Access to Medicine Index 2021 – Company report cards BAY RANK SCORE . Bayer AG Stock Exchange: Frankfurt Stock Exchange • Ticker: BAYN • HQ: Leverkusen, Germany • Employees: 103,824 PERFORMANCE IN THE 2021 INDEX How score was achieved 13th place. Bayer has an average performance. It delivers a Governance of Access 3.55 strong approach to filing its new products for registration, Research & Development 1.01 but has a small-sized R&D priority pipeline and no structured process for access planning. Its approach to governance and Product Delivery 3.03 compliance is average. 0 1 2 3 4 5 Average Leader Governance of Access: 8th place. Bayer has an average per- formance in this area. It implements an access-to-medicine strategy with a business rationale and discloses outcomes of some of its access-to-medicine activities. The company has some compliance controls in place, but lacks evidence of a continuous system to monitor compliance across its activities. Product Delivery: 11th place. Bayer has an average perfor- mance in this area. It has filed to register the majority of Research & Development: 17th place. Bayer falls to the lower its new products in the majority of high-burden countries. ranks in R&D. The company features a small-sized R&D prior- The company has access strategies for some of its products ity pipeline compared to peers and does not have a structured and for some countries in scope and is able to provide evi- process to develop access plans during R&D. A few of its late- dence of how patient reach has been increased through the stage R&D projects are covered by access plans . approaches used. OPPORTUNITIES FOR BAYER CHANGE SINCE THE 2018 INDEX Expand access to more products. Bayer offers certain contraceptives for • Created a new external sustainability council to contribute to procurement through UNFPA for eligible countries and offers the same Bayer innovation, mindset and strategy as from May 2020. terms and price to non-eligible countries for ethinylestradiol/levonorge- • Disclosed a new commitment not to enforce or file for pat- strel/ferrous fumerate (Microgynon® ED Fe/Microgynon® Fe). Bayer can ents in all LICs. apply the same strategy in non-eligible countries for norethisterone enan- • Joined Pat-INFORMED, publishing patent statuses for prod- tate (Noristerat®). Furthermore, Bayer can apply equitable pricing strat- ucts in their portfolio. egies for contraceptives that are not procured through UNFPA: drosperi- • Supports the clinical development of novel antibiotics via the none/ethinylestradiol (Yasmin®), Estradiol valerate/dienogest (Qlaira®/ AMR Action Fund. Natazia®) or estradiol valerate/norethisterone enantate (Norigynon®), • Joined the COVID-19 Therapeutics Accelerator. specifically in countries with a low contraceptive prevalence rate such as • Started a new two-year partnership in January 2020 with Angola, Gambia, Guinea and Mauritania. Outside contraceptives, Bayer can Living Goods to train Community Health Workers on family expand affordable access to on patent EML products such as rivaroxaban planning and neonatal care in rural Uganda. (Xarelto®) for the prevention of stroke. • Established a new partnership with PATH for malaria and COVID-19 in Southern Senegal. Develop an access planning process and access plans for all R&D pro- • Newly partnered with the UN Foundation for malaria eradica- jects. Bayer can develop a formal access planning process and accord- tion by donating Fludora® Fusion for vector control in Haiti. ingly develop access plans for all Phase II projects, such as levonorgestrel/ • Has a new collaboration with John Hopkins University for indomethacin (a combination intrauterine device). Bayer can also further The Challenge Initiative platform to enable governments in strengthen its recently updated post-trial access policy by committing countries in scope of the Index to scale up family planning to filing the product for registration in countries where clinical trials take approaches for poorer populations in urban areas. place, while ensuring affordability. Commit to donating until NTD elimination and control goals. In partner- ship with the WHO since 2002, Bayer has worked to eliminate African Sleeping Sickness (HAT) and to control Chagas disease in Latin America by donating suramin (Germanin®) and nifurtimox (Lampit®) until 2021. Bayer can extend its public commitment indefinitely until elimination of HAT and control of Chagas disease in Latin America. The term LMIC is used to denote all low- and mid- dle-income countries in the scope of the Index, except when analysing companies’ access strat- 140 egies where the use of LMIC refers to lower-mid- dle-income countries as per the World Bank income groups classification. Access to Medicine Foundation SALES AND OPERATIONS Business segments: Crop Science; KaNDy Therapeutics (women’s healthcare) and Net sales by segment (2019) – EUR Pharmaceuticals; Consumer Health of Asklepios BioPharmaceutical (gene thera- Therapeutic areas: Cancer; Cardiovascular and pies) in 2020. Crop Science 19.832 bn kidney diseases; Eye conditions; Haemophilia; Pharmaceuticals 17.962 bn Contraception Bayer Pharma’s products are sold in 92 out of Consumer Health 5.462 bn Product categories: Innovative medicines 106 countries in scope. Bayer Pharma has sales Reconciliation 0.289 bn M&A news: Divested Bayer Animal Health offices in 37 countries, sells via suppliers in 7 to Elanco in August 2019 for USD 7.6 billion; countries and via pooled procurement into 48 Total 43.545 bn acquired BlueRock (neurology) and Century additional countries. (oncology) in 2019; announced acquisition of Sales in countries in scope Sales by geographic region BAY BN EUR In scope, has sales oce In scope, any sales In scope, has no sales Europe/Middle East/Africa Asia-Pacic Not in scope Latin America North America SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEX PIPELINE for diseases and countries in scope PORTFOLIO as selected for analysis by the Index Bayer has a total of 42 R&D projects featuring a small-sized priority R&D Bayer has 21 medicines and contraceptives in scope, 11 of which are on pipeline compared to its peers: 7 projects. The other 35 R&D projects patent. 67% of these medicines and contraceptives (14) are on WHO’s EML. target other diseases in scope. Of the projects targeting priority diseases In addition, the company markets 12 vector control products. The off-pat- the focus is on Chagas disease (2 projects). Of the projects targeting other ent medicines target mainly neglected tropical diseases (NTD), such as diseases in scope the focus is on oncology (18). schistosomiasis, Chagas and Human African Trypanosomiasis. One medi- 17 R&D projects are in late-stage development that target either a prior- cine targets malaria. The on-patent medicines mainly target non-commu- ity disease (6) or address a public health need in LMICs (11).* Evidence of nicable diseases, such as oncology (5), cardiovascular disease and endo- access planning was in place for 24% of these projects: 3 targeting a prior- metriosis. Additionally, one medicine targets bacterial infections. Bayer has ity disease and 1 addressing a public health need in LMICs. eight contraceptives in scope. The vector control products target malaria, dengue, Chikungunya and Zika. Access strategies were analysed for 11 products on Bayer’s portfolio – supranationally procured (4) or nationally procured HCP-administered (2) and self-administered products (5). BAY 42 projects in the pipeline 33 products as selected for analysis by the Index† Communicable Communicable** Neglected tropical Neglected tropical Maternal and neonatal Maternal and neonatal Non-communicable Non-communicable Multiple categories Multiple categories projects in the pipeline products on the market Breakdown of projects# BreakdownBAY of products Levonorgestrel/indomethacin releasing intrauterine system for contraception. WHO EML Non-EML WHO EDL Other Total Medicines on patent Pre-clinical 1 Phase 2 Phase 3 Phase Approval Total plans access W. o patent Targets established R&D priorities Vaccines Addresses needs of LMICs* Diagnostics Other projects in scope Other*** *50 diseases and 211 product gaps in scope have ical phase of development were included for this ***Other includes vector control products. See #Projects in the discovery phases and/or other been established as a priority by global health analysis. Appendix I for definitions. drug development phases were not included in stakeholders. For other diseases/product gaps, **Neglected Tropical Diseases, while also † Product included in the analysis were selected this breakdown. the Index used a set of criteria to determine which communicable, are highlighted separately using a set of criteria determined by stakeholder 141 projects in the pipeline offer a clear public health throughout the Index. consensus. See Appendix I for a full breakdown benefit to patients in LMICs. Projects in the clin- of the criteria. Access to Medicine Index 2021 – Company report cards Bayer AG GOVERNANCE OF ACCESS RANK 8 SCORE 3.55 Has an access-to-medicine strategy with measurable transparency regarding access activities. It publicly dis- Has some compliance controls to ensure that govern- objectives and a business rationale. Bayer has an average closes its commitments, measurable goals, objectives and ance efforts are not undermined by non-compliant or performance. It has an access strategy aiming at increasing targets for improving access