European Drug Forecasts

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1 European Drug Forecasts Methodology and sources INTERNAL USE ONLY

2 The first EU dataset based on government and company-reported data and enabling a through horizon scanning of the EU landscape Building blocks R&D product forecast forecast of 500+ R&D products Comprehensive horizon scanning of Ph2 and Ph3 medicines likely to hit the EU market In-line product forecast forecast of marketed drugs based on modelling of brokers forecast Proprietary methodology applied (uptake curve, therapy area analogues, time to market benchmarks) Historical sales Consolidation, cleaning and interpretation of government reported data (sales, volume and pricing) of 300+ marketed drugs for all EU countries Validation with company reported data EVP Proprietary methodology to estimate missing data

3 Contents Design and methodology: historical sales Design and methodology: forecast sales

4 Built upon data from all EU-5 countries plus some of the other key European markets EU-5 coverage Top 100 brands (GKV) + full generic coverage Ongoing expansion of country list Full primary care + top 50 hospital drugs Top 300 drugs across all distribution channels Full primary care + top 200 hospital drugs (including CDF) Top 100 drugs Other countries include: Netherlands, Finland, Portugal, Czech Rep., Denmark Covered Estimated

5 Historical data curated and validated based on a 4-step methodology to ensure high accuracy 1. Reported sales info 2. Consolidation 3. Cleaning 4. Validation Government dataset (e.g. GAMSI, OSMED, NHS) Raw EU data set Apply mark-ups to ensure all sales are ex-factory Estimate missing data based on country split statistics (EFPIA) and product trend data Consistent therapy area trends Checked against major events (e.g. generic/biosimilars) Volume Sales Pricing Projection of monthly/ quarterly data to provide full annual picture Cross-country comparisons of key statistics/ratios (e.g. sales/population) Company reported data Accuracy bar Accuracy bar Accuracy bar

6 Country sources - Germany GAMSI provide a comprehensive overview of the pharma sales reimbursed by the GKV (sickness fund association) Sales SOURCES GAMSI data (GKV, sickness fund association) for branded products reimbursed by GKV - quarterly Generic coverage via Federal Health Monitoring System (GKV) - annual Price detail Price/pack Price/Rx Price Ex-factory, retail (calculated) RETAIL DATA GAMSI data Top 5 products by ATC and top 20 products in the whole German market Mark-ups netted off to obtain ex-factory sales HOSPITAL DATA Same as retail (above) Oncology drugs available from Q Commercial discounts not reported Price/DDD (calculated) Volume Volume (pack) Volume (Rx) Volume (DDD) Volume (patients)

7 Country sources - France Extensive primary care coverage (including detailed generic analysis) Not recent hospital data available Sales SOURCES AMELI data (primary care sales) annual and monthly AFSSAPS (hospital sales) up to 2013 CEPS/Assurance Maladie for pricing data Price detail Price/pack Price/Rx Price Ex-factory, retail (can be calculated) RETAIL DATA 16,000 + pack level data Mark-up calculates based on retail vs. exfactory pricing data available at pack level Includes generic data HOSPITAL DATA Coverage from 2007 to 2013 Estimated from 2014 onward Price/DDD Volume (pack) Volume (Rx) Volume (DDD) (coming up) Volume (can be calculated) Volume (patients)

Country sources - UK Comprehensive coverage of NHS England in terms of sales, volumes and pricing Other nations not covered Sales SOURCES NHS England quarterly and annual NHS Prescription service

8 Country sources - UK Comprehensive coverage of NHS England in terms of sales, volumes and pricing Other nations not covered Sales SOURCES NHS England quarterly and annual NHS Prescription service (Part VIIIA, VIIIB) NHS Prescription Cost analysis monthly, quarterly RETAIL DATA Full view of NHS primary care sales and volumes (released with 3-month delay) Detailed generic data also available Price detail Price/pack Price/Rx Price/DDD Volume (pack) Price Ex-factory (coming up) Volume HOSPITAL DATA / DIRECT DISTRIBUTION Based on NHS England data annual Integrated with Cancer Drug Fund data for oncology products Volume (Rx) Volume (DDD) Volume (patients) (can be calculated)

9 Country sources - Italy OSMED provide a comprehensive view of the Italian pharma markets by channels (hospital, retail, direct distribution) Sales SOURCES OSMED - sales, volume data by channel (hospital, direct distribution, retail) anually + Jan-Sept preview AIFA list for pricing data - monthly RETAIL DATA Top products by ATC distributed by retail pharmacies Netted off of pharmacy/wholesaler markups (3% / 30.35% margins applied) Price detail Price/pack Price/Rx Price/DDD Volume (pack) Price Ex-factory, retail Volume HOSPITAL DATA / DIRECT DISTRIBUTION Top products by ATC distributed by hospital centres or via direct distribution Sales based on list prices, commercial discounts not included Volume (Rx) Volume (DDD) Volume (patients)

Country sources - Spain Coverage limited to top ~50 selling drugs disclosed by the Ministry of Health Sales SOURCES Primary care & hospital top selling drugs (Ministerio de Sanidad, Ministry of

10 Country sources - Spain Coverage limited to top ~50 selling drugs disclosed by the Ministry of Health Sales SOURCES Primary care & hospital top selling drugs (Ministerio de Sanidad, Ministry of Health) Annual coverage RETAIL DATA Top ~50 selling drugs in Spain, Net of Rebate and VAT HOSPITAL DATA / DIRECT DISTRIBUTION Top ~50 selling drugs in Spain, Net of Rebate and VAT Price detail Price/pack Price/Rx Price/DDD Volume (pack) Volume (Rx) Volume (DDD) Price Ex-factory, retail Volume Volume (patients)

Country sources - Netherlands Extensive coverage of primary care products via GIP data Sales SOURCES Primary care (source: GIP) which covers all medicines outside hospitals and nursing homes - Annual

11 Country sources - Netherlands Extensive coverage of primary care products via GIP data Sales SOURCES Primary care (source: GIP) which covers all medicines outside hospitals and nursing homes - Annual RETAIL DATA 400+ drugs in primary care, Annual coverage, GIP HOSPITAL DATA / DIRECT DISTRIBUTION Not available Price detail Price/pack Price/Rx Price/DDD Volume (pack) Volume (Rx) Volume (DDD) Price Ex-factory, retail Volume Volume (patients)

Country sources - Denmark Extensive coverage of both primary care and hospital sector Sales SOURCES Primary care (source: Sundhedsdata) and hospital (source: MedStat) for 2500+ drugs in Denmark -

12 Country sources - Denmark Extensive coverage of both primary care and hospital sector Sales SOURCES Primary care (source: Sundhedsdata) and hospital (source: MedStat) for drugs in Denmark - quarterly Pricing data for 4000 drugs (source: SSI) RETAIL DATA Full coverage of primary care sales in Denmark (2500+ drugs 2011 onward) (source: Sundhedsdata) Price detail Price/pack Price/Rx Price/DDD Volume (pack) Price Ex-factory, retail Volume HOSPITAL DATA / DIRECT DISTRIBUTION Full coverage of hospital products sold in Denmark annual update (source: MedStat) Volume (Rx) Volume (DDD) Volume (patients)

Country sources - Finland Extensive coverage of ~2,000 products across primary care and hospital Sales SOURCES Primary care & hospital coverage (source: FIMEA) quarterly reporting RETAIL DATA ~1900

13 Country sources - Finland Extensive coverage of ~2,000 products across primary care and hospital Sales SOURCES Primary care & hospital coverage (source: FIMEA) quarterly reporting RETAIL DATA ~1900 drugs quarterly (source: FIMEA) HOSPITAL DATA / DIRECT DISTRIBUTION ~1900 drugs quarterly (source: FIMEA) Price detail Price/pack Price/Rx Price/DDD Volume (pack) Volume (Rx) Volume (DDD) Price Ex-factory, retail Volume Volume (patients)

Country sources - Portugal INFARMED data provide good coverage of primary care and hospital products Sales SOURCES Primary care & hospital coverage (source: INFARMED) annual reporting RETAIL DATA Top

14 Country sources - Portugal INFARMED data provide good coverage of primary care and hospital products Sales SOURCES Primary care & hospital coverage (source: INFARMED) annual reporting RETAIL DATA Top 100 drugs by sales and Top 100 by Volume (source: INFARMED) - annual HOSPITAL DATA / DIRECT DISTRIBUTION Top hospital drugs and orphan drugs (source: INFARMED) - annual Price detail Price/pack Price/Rx Price/DDD Volume (pack) Volume (Rx) Volume (DDD) Price Ex-factory, retail Volume Volume (patients)

Country sources Czech Republic Extensive and up to date coverage of products across primary care and hospital Sales SOURCES Primary care & hospital coverage (source: SUKL) annual and monthly

15 Country sources Czech Republic Extensive and up to date coverage of products across primary care and hospital Sales SOURCES Primary care & hospital coverage (source: SUKL) annual and monthly reporting RETAIL DATA ~6,000 packs covered from monthly and annual reporting (source: SUKL) Price detail Price/pack Price/Rx Price/DDD Volume (pack) Price Ex-factory, retail Volume HOSPITAL DATA / DIRECT DISTRIBUTION ~6,000 packs covered from monthly and annual reporting (source: SUKL) Volume (Rx) Volume (DDD) Volume (patients)

16 Contents Design and methodology: historical sales Design and methodology: forecast sales

17 What EU Drug Forecast is and is not WHAT IT IS sales projection based on consensus forecast, either at EU level or extrapolation of RoW and WW data WHAT IT IS NOT Patient-based forecast built on granular epidemiological data and pricing assumptions EU historical sales from government and company reported sources are key inputs Enriched with proprietary inputs

18 The methodology built upon brokers forecast and enhanced by EVP s proprietary inputs Forecast inputs In-line product forecast R&D product forecast Brokers forecast EU historical data from government/company reported data Analogues to model country uptake Expected launch timelines Expected generic entry Generic erosion curves Time to market benchmark Major events at therapy area level for validation Evaluate Proprietary methodology

Specific methodology for each product cluster Spit by indication will be released in the second wave (likely in H2 2016) Product clustering based on 3 main variables # Prd stage Indication Gx until

19 Specific methodology for each product cluster Spit by indication will be released in the second wave (likely in H2 2016) Product clustering based on 3 main variables # Prd stage Indication Gx until In-line Single No 2 Pipeline Single No 3 In-line Single Yes 4 Pipeline Single Yes 5 In-line Multiple No Unlikely to find a pipeline product with generics before Pipeline Multiple No 7 In-line Multiple Yes 8 Pipeline Multiple Yes

20 Product cluster 1) Methodology decision flow Prd stage Indication Gx until 2022 In-line Single No EU broker forecast available Yes No Available at individual country level Available at EU total level only Estimate EU forecast by using historical ratio between EU total and WW/RoW and apply to WW/RoW forecast Use disclosed data for the countries estimated by the brokers Ensure alignment with historical sales (if only available from EU SVP methodology) Established (3+ years) Apply the country share from historical Validate against observed historical growth and/or uptake curve for similar products Newly launched (1-3 years) Apply the country share from historical Validate against observed historical growth and/or uptake curve for similar products Established (3+ years) Apply the country share istorical from EU SVP Validate against observed historical growth and/or uptake curve for similar products Newly launched (1-3 years) Apply the country share from historical Validate against observed historical growth and/or uptake curve for similar products

21 Product cluster 2) Methodology decision flow Prd stage Indication Gx until 2022 Pipeline Single No EU broker forecast available Yes No Available at individual country level Use disclosed data for the countries estimated by the brokers Available at EU total level only Apply the country share from historical data Validate against uptake curve for similar products Account for differences in time-to-market across EU markets RVT-101 (Axovant Sciences) Estimate EU forecast by using historical ratio between EU total and WW/RoW and apply to WW/RoW forecast 1 Ocrelizumab (Roche) Apply the country share from EU SVP Validate against observed historical growth and/or uptake curve for similar products Account for differences in time-to-market across EU markets 1 Use ratio of products with similar profile in terms of budget impact, degree of innovation, TA

Product cluster 3) Methodology decision flow Prd stage Indication Gx until 2022 In-line Single Yes Same methodology applied to in-line products with a single indication (#1)

22 Product cluster 3) Methodology decision flow Prd stage Indication Gx until 2022 In-line Single Yes Same methodology applied to in-line products with a single indication (#1) If generic entry aligned to WW/US figure, simply apply country share from historical data If not aligned or generics not factored in, apply erosion curve based on EU analogues

23 Product cluster 4) Methodology decision flow Prd stage Indication Gx until 2022 Pipeline Single Yes EU broker forecast available Yes No Available at individual country level Use disclosed data for the countries estimated by the brokers Available at EU total level only Apply the country share from EU SVP Validate against uptake curve for similar products Account for differences in time-to-market across EU markets RVT-101 (Axovant Sciences) Estimate EU forecast by using historical ratio between EU total and WW/RoW and apply to WW/RoW forecast 1 Ocrelizumab (Roche) Apply the country share from EU SVP Validate against observed historical growth and/or uptake curve for similar products Account for differences in time-to-market across EU markets 1 Use ratio of products with similar profile in terms of budget impact, degree of innovation, TA

Product clusters 5-8) Methodology decision flow Prd stage

When multiple indications are involved In-line products

sales Remove countries where the indication has not been

methodology if more than one indication will be approved

24 Product clusters 5-8) Methodology decision flow Prd stage Indication Gx until 2022 In-line/pipeline Multiple Yes/No When multiple indications are involved In-line products Apply the Split by Indication methodology to EU country sales Remove countries where the indication has not been approved Pipeline products Apply Split by indication methodology if more than one indication will be approved before 2022 Spit by indication will be released in the second wave (likely in H2 2016)

25 Forecast methdology example Herceptin Lantus, EUR mio mio Europe historical sales 2,031 2,002 2,068 2,117 Historical sales are based on government and company reported data Consensus growth vs. previous year 3.3% -2.9% -1.2% -0.9% -2.8% -3.4% -4.1% 3.3% Europe historical and forecast sales 2,187 2,124 2,099 2,080 2,022 1,953 1,872 Country sales e.g. Germany Germany accounts for 14.8% of Herceptin sales in Europe The ratio has been applied to the European Additional adjustments Launch date validation Generic/biosimilars impact We checked the launch date and the availability of products in the EU-5 markets to ensure that the product is actually marketed (e.g. Tradjenta not available in France and Germany) As some of the conensus forecast did not fully reflect the impact of likely generic/biosimilar competition, we applied generic erosion adjustment for selected products (e.g. Erbitux)

26 Time to market benchmark for EU launch sequencing of R&D and recently approved in line products (e.g. Repatha, Entresto) Time to market across EU markets Time gap between EMA approval and local reimbursement (Source: IMS 2015) EU average = 11 months EU5 RoE

27 Analogue-based inputs for country split across therapy areas Country breakdown across therapy areas (selected sample) 100% 80% 60% 40% 20% 0% 33% 32% 41% 33% 36% 8% 10% 11% 9% 13% 8% 6% 11% 10% 14% 11% 15% 5% 12% 12% 17% 19% 18% 18% 11% 17% 16% 16% 14% 22% EFPIA Asthma Breast cancer Diabetes Anti-TNF/IL-6 Rest of Europe Spain Italy United Kingdom France Germany Product sample Seretide/Advair, Symbicort, Xolair, Ventolin Product sample Herceptin, Kadcyla, Perjeta, Tykerb Product sample Bydureon, Byetta, Humalog, Januvia, Janumet, Lantus, Levemir, Victoza, Onglyza Product sample Enbrel, Cimzia, Humira, Simponi, Actemra

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