IQVIA DEFINITIONS (May 2021) DOWNLOADED VIA ANALYSIS): ON IQVIA PORTAL FOR THE BELOW SECTIONS (EXCEPT SALES DATA Data Source(s) / Report Description / Definitions / Coverage / Updates / MIDAS Panel Coverage / Disease Module: Medical Panel Coverage / Exchange Rates / Methodology Data Source(s) 1. MIDAS Audited Value The figures for the data source represent cash value sales derived from MIDAS data based on sales calculated at manufacturer selling prices. The data grid shows a aggregated total sales for the country, the top 20 products based on latest sales and total others for all other products outside of the top 20. The sales for each of the top 20 products and total others represents aggregated total from sales in the specific country hub you are in. 2. MIDAS Audited Volume The figures for the data source represent volume sales derived from MIDAS data. The data grid shows a aggregated total sales for the country, the top 20 products based on latest sales and total others for all other products outside of the top 20. The sales for each of the top 20 products and total others represents aggregated total from sales in the specific country hub you are in. The list of 20 products remain the same as MIDAS Audited Value when the data source is changed to MIDAS Audited Volume. • • • • Standard Units volume measurement represents the number of smallest common form doses sold. For example for a tablet form product, standard units will show the number of tables sold. For certain formulations the dose is defined by IMS according to the product form. Please note all though standard units are derived at a form level, data at a form level is not available in the platform. 3. MIDAS Audited Kilogram The figures for the data source represent chemical weight sales derived from MIDAS data. The data grid shows a aggregated total sales for the country, the top 20 products based on latest sales and total others for all other products outside of the top 20. The sales for each of the top 20 products and total others represents aggregated total from sale in the specific country hub you are in. The list of 20 products remain the same as MIDAS Audited Value when the data source is changed to MIDAS Audited Kilogram. 4. MIDAS Patient Day The figures for the data source represent patient days sales derived from MIDAS data by combining dividing MIDAS standard unit sales by average daily dose (AVDD). NB: The patient days measure data is not available for oncology data. 5. Average Daily Dose The average daily dose in standard units, based on MIDAS Prescribing Insights summary data and other secondary research. 6. MIDAS Sales Level Implied Price per Standard Unit The figures for the data source represent the implied price driven based on MIDAS Audited MNF value and standard units. Price per standard unit is only accessible to Forecast Link and AC Enhanced Module subscribers. However, it be calculated by running both MIDAS sales value and volume extracts and calculating the factor between the two to derive the implied price. For the below example, 80,239,584 / 50,725,161 = $0.625. 7. MIDAS Sales Level Implied Price per Patient Day The figures for the data source represent the implied price driven based on MIDAS Audited MNF value and patient days. 8. Company reported Sales Value Company reported sales values show product sales aligned with published annual and quarterly reported data for 160 companies. 9. Analyst Consensus Value Analyst consensus provides a 7 year forecast based on a mean average of broker forecasts produced by investment bank and security firm analysts. Company reported/Analyst consensus volume provides a 5 year historical and 7 year forecast which are based on SU driven in lockstep with company reported and analyst consensus values respectively. 10. Company-reported Sales Level Implied Price per Standard Units The figures for the data source represent the implied price driven based on company reported sales value and standard units. 11. MIDAS Audited Value/OTC Value The figures for the data source represent cash value sales derived from MIDAS and OTCims data based on sales calculated at manufacturer selling prices. The data grid shows a total for the molecular entity across the countries covered within the platform, the top 20 products based on latest sales and total others for all other products outside of the top 20. The sales for each of the top 20 products and total others also represents global sales across the countries within the platform. Bain does not subscribe to IQVIA’s OTC module. 12. MIDAS Audited Volume/OTC Volume The figures for the data source represent volume sales derived from MIDAS and OTC IMS data. The data grid shows a total for the molecular entity across the countries covered within the platform, the top 20 products based on latest sales (by value) and total others for all other products outside of the top 20. The sales for each of the top 20 products and total others also represents global sales across the countries within the platform. The list of 20 products remain the same as MIDAS Audited Value/OTC Value when the data source is changed to MIDAS Audited Volume/OTC Volume. Report Description 1. MIDAS Audited Value The figures for the data source represent cash value sales derived from MIDAS data based on sales calculated at manufacturer selling prices. The data grid shows a total for the country you are in, the top 20 products based on latest calendar year sales and total others for all other products outside of the top 20. The sales for each of the top 20 products and total others also represents total sales for the country. 2. MIDAS Audited Volume The figures for the data source represent volume sales derived from MIDAS data. The data grid shows a total for the country you are in, the top 20 products based on latest calendar year sales and total others for all other products outside of the top 20. The sales for each of the top 20 products and total others also represents total sales for the country. The list of 20 products remain the same as MIDAS Audited value when the data source is changed to MIDAS Audited Volume. 3. MIDAS Audited Kilogram The figures for the data source represent chemical weight sales derived from MIDAS data. The data grid shows a total for the country you are in, the top 20 products based on latest calendar year sales and total others for all other products outside of the top 20. The sales for each of the top 20 products and total others also represents total sales for the country. The list of 20 products remain the same as MIDAS Audited Value when the data source is changed to MIDAS Audited Kilogram. 4. MIDAS Patient Day The figures for the data source represent patient days sales derived from MIDAS data by combining dividing MIDAS standard unit sales by average daily dose (AVDD). This offers a dose-adjusted volume measure of sales that is directly comparable across products. 5. Average Daily Dose The average daily dose in standard units, based on MIDAS Prescribing Insights summary data and other secondary research. AVDD varies for each product by route of administration, and where necessary, is also disease or region specific. 6. MIDAS Sales Level Implied Price per Standard Unit The figures for the data source represent the implied price driven based on MIDAS Audited MNF value and standard units. 7. MIDAS Sales Level Implied Price per Patient Day The figures for the data source represent the implied price driven based on MIDAS Audited MNF value and patient days. 8. Company reported sales Company reported sales values show product sales for the country you are in and are derived from sales aligned with published annual and quarterly reported data for 160 companies. 9. Analyst Consensus value forecasts Analyst consensus sales value show product sales for the country you are in and is based on a mean average of broker forecasts produced by investment bank and security firm analysts. 10. Company reported/Analyst Consensus Volume forecasts Company reported/Analyst consensus volume show product sales for the country you are in and is based on SU derived in lockstep with company reported value and analyst consensus values respectively. 11. Company-reported Sales Level Implied Price per Standard Units The figures for the data source represent the implied price for the country you are in, driven based on company reported sales value and standard units. Definitions 1. International Product Name (Brand Name) For products on the market, IQVIA consolidates the various brand names used in different countries. Usually this is the ‘commonly used’ name or the name from the country of first launch. Products are consolidated under one name if 2 out of 3 of the following match: product name, corporation, and active ingredient. When a product cannot be grouped in this way with any other products internationally it is identified with an "@" symbol along with the country it is available in. In the case where a ‘generic name’ is used, an abbreviation of the owning company’s name is added, where it is known. For drugs of this type consolidated under one name, the 3 out of 3 of the following criteria must match: product name, corporation, and active ingredient. 2. Pharmaceutical Molecule Name The name of the molecular entity 3. Corporation The Corporation column represents the corporations which have sales for the product within MIDAS data. The primary corporation which is specified in the grid is the corporation with the highest sales for the product in MIDAS data. If the corporation has a + sign followed by a number, for example +10, hovering over the +10 reveals a list of 10 other corporations which also have sales for this product in MIDAS data. 4. ATC IMS use the hierarchical Anatomical Therapeutic Classification (ATC) standard. It is a way of grouping, and therefore a way to look at, similar products. At its broadest level the system classifies products according to the parts of the body that they are used to treat. At the lower levels it uses therapeutic use, indication, mode of action, pharmacology etc. to define sub groups. Classes consist of a description and/or code. Both are used throughout this service. Code Description Level A Alimentary Tract and Metabolism Level 1 A2 Antacids, Antiflatulents and Antipeptic Ulcerants Level 2 A2A Antacids, Antiflatulents, Carminatives Level 3 A2A1 Plain Antacids Level 4 The EphMRA (European Pharmaceutical Market Research Association) Classification Committee originally prepared the Anatomical Therapeutic Classification Guidelines. More information can be found at www.ephmra.org. The primary objective of the Anatomical Therapeutic Classification is to satisfy the marketing needs of companies who are engaged in researching the pharmaceutical industry. Products are mainly classified according to their indications and use. Therefore it is possible to find the same compound in several classes; e.g. ibuprofen can be classified in M1A (Anti-rheumatic), N2B (Analgesic) and G2X (Other Gynaecological Products) if indicated for gynaecological conditions only. 5. Disease The Disease column represents the Disease area (according to the Analytics disease taxonomy) or a specific ICD10 code 6. Primary / Specialty Drugs in each ATC have been classified as specialty if they treat specific, complex chronic diseases with four or more of the following attributes: Initiated only by a specialist, generally not oral form, require special handling, unique distribution, high expense, warrants intensive patient counselling, requires reimbursement assistance. 7. Channel The split by channel is based on sales across all sales for each channel type. The list of channel types is as follows: Retail Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Central America, Chile, China, Colombia, Croatia, Czech republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French West Africa, Germany (retail), Greece, Hungary, Indonesia (Retail, Drug), Ireland, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Mexico, Morocco, Netherlands (Xponent), New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia (Retail+DLO), Saudi Arabia, Slovak Republic, Spain (retail), Sri Lanka, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, UK (SellIn), Uruguay (Retail + Mutuales), USA (Drugstore, Foodstore, Mail Service), Venezuela and Vietnam. Hospital Australia, Austria, Belgium, Bulgaria, Canada, China, Croatia, Czech republic, Finland, France, Germany, Hungary, Indonesia, Ireland, Italy (Hospital+DPC), Japan, Kazakhstan (Non-retail), Korea (Hospital+Clinic), Lithuania, Malaysia, Netherlands (Hospital IMS), New Zealand, Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, Saudi Arabia (LPO), Slovak Republic, South Africa, Spain, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, UK, USA (Non-Fed Hospital, Misc, Long Term Care, Home Health Care, HMO, Fed Facilities, Clinic) and Vietnam. Combined Hong Kong, India (total sales), Malaysia, Serbia, Singapore, Slovenia, Sweden, South Africa. 8. Generic / Non-Generic The generic product classification is based on the market segmentation generic product classification derived from MIDAS which assigns each local product to one of six categories: Biocomparable Products, Early Entry Generic Products, Non Generic products, Generic Products, Other Products and Non Categorized products. This classification currently covers the 33 countries outlined in coverage. Sales for all other countries are assigned to Non categorized products category. BIOCOMPARABLES – Products that have been approved through official biosimilar approval pathways in countries where this process exists. In addition, products of the same molecule, brand name and corporation in countries without official biosimilar approval processes are also classified in this category. GENERIC PRODUCTS – Products that fall within the IMS definition of a generic product • i.e. Products that have never benefited from any form of protection, were launched post-protection expiry of the original product and were subsequently launched products to the original OR either company branded or unbranded products that are no longer protected (early entry licensed generic products). • NON-GENERIC PRODUCTS – Products that fall within the IMS definition of a nongeneric product • i.e. Products that currently benefit from any form of protection, OR branded products that have once but no longer benefit from some form of protection OR first launch products (i.e. the product of that composition with the earliest launch date in that country) that have never benefited from any form of protection, were launched post-protection expiry of the original product • OTHER PRODUCTS - Products that have never benefited from any form of protection and were launched pre-protection expiry of the original product. • NON CATEGORISED PRODUCTS - products for which Protection is coded as Under Investigation, Unknown or Not Covered 9. Biologic / Non Biologic Data is categorized at a molecule level and then aggregated up to the following categories: Biologic product - If a product contains a Biologic molecule as the active ingredient (or a number of Biologic molecules are active ingredients) and there are no Non-Biologic molecules present as active ingredients then the product is defined as Biologic Product. Non Biologic Product - A product that contains only Non-Biologic molecule(s) as the active ingredient(s) is defined as a Non-Biologic Product. Bio/Non Bio Combi product - A product that contains both a Biologic and a Non-Biologic molecule(s) is defined a Bio/Non Bio Combi product. BIO-PRD Unknown - The category of BIO-PRD Unknown occurs only when the composition of all packs of a product are unknown. In such a case, with no known ingredients, the biologic status of the product's ingredients cannot be determined. IMS uses the following defining characteristics to categorize a biologic: Molecular structure - Biologic molecules are complex macromolecules, typically with some form of polymer structure. Specific macromolecules included in this definition are proteins, nucleic acids and carbohydrates. Molecular Identification - Biologic molecules must be clearly identified. Any 'molecule' where the molecule name is descriptive and the actual composition of the molecule is not identified (e.g. Vegetable Extract) will not be classified as a biologic. Active Substance - Biologic molecules must be, or are intended to be clearly defined active therapeutic ingredients in a product. Regulatory - Biologic molecules must have undergone (or be undergoing) a regulatory human clinical trial programme under the auspices of a national / regional regulatory authority. 10. Change The change column represents the value change from the earliest time period to the latest time period. 11. Currency The sales data is convertible into a number of different currencies from the drop down list above the sales data grid. The sales are converted from each local currency for the 70+ countries in the Analytics Link universe to the currency selected from the drop down. The currencies are supplied to IMS based on a quarterly average between the local and selected currencies by Oanda. Analytics Link uses these quarterly average rates to convert the sales into the selected currency and provides an aggregated total for the calendar year or moving annual total. For Euros, Dollars and Pound Sterling, there is also a constant exchange rate option which uses the last quarter in the time series to reference the average exchange rate and then applies this rate to all previous periods. The constant currency option are shown as LC US Dollars, LC Euros & LC Pound Sterling within the currency drop down. For a list of exchange rates, please see the last section of the 'user guide' available from the 'Help' link at the top of the screen. 12. Standard Units Standard Units volume measurement represents the number of smallest common form doses sold. For example for a tablet form product, Standard Units will show the number of tablets sold. For certain formulations the dose is defined by IMS according to the product form. Please note although Standard Units volume is derived at a form level, data at a form level is not available in the platform. 13. MIDAS Audited Kilogram Kilogram measurement represents chemical weight of active ingredient (molecule) in the product. Please note, kilogram values for all combination products (e.g. Seretide, fluticasone + salmeterol) represent aggregated kilogram sales of all constituent molecules (e.g. fluticasone + salmeterol combined). 14. Patient Days Patient Days measurement represents sales derived from MIDAS data by combining dividing MIDAS standard unit sales by average daily dose (AVDD). This offers a doseadjusted volume measure of sales that is directly comparable across products. NB: The patient days measure data is not available for oncology data. 15. Company reported sales value Company reported sales values provides a 10 year historical product sales for the global brand and are derived from sales reported to the stock market by public listed companies from the top 1200 companies available in the platform. 16. Analyst Consensus value forecasts Analyst consensus provides a 7 year forecast value based on a mean average of broker forecasts produced by investment bank and security firm analysts. A minimum of 3 broker reports published within the same quarter are used to create the consensus forecast. Some of the brokers behind the analyst consensus forecasts include brokers from: Bank am Bellevue, Barclays, Cantor Fitzgerald, Cowen & Co, Credit Suisse, Deutsche Bank, Guggenheim, Jefferies, JP Morgan, Leerink Swann, Mitsubishi UFJ, Morgan Stanley, Piper Jaffray, RBC Captial, SMBC Nikko, Societe Generale and Wedbush. This is a representative list of brokers used, not exhaustive. 17. Company reported/Analyst consensus forecasts Company reported/Analyst consensus volume provides a 5 year historical and 7 year forecast which are based on SU driven in lockstep with company reported and analyst consensus sales value respectively. Coverage 1. Country specific MIDAS Audited Value, MIDAS Audited Volume, MIDAS Audited Kilogram and MIDAS Audited Patient Day coverage MIDAS Audited Value, MIDAS Audited Volume, MIDAS Audited Kilogram and MIDAS Patient Day are based on an aggregated total from sales in the specific country hub you are in. 2. Generic / Non-Generic coverage Figures are global aggregated totals from the following countries covered by MIDAS market segmentation coding: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, United Arab Emirates, Uruguay, USA, Venezuela and Vietnam. 3. Company reported sales coverage Company reported sales represent global sales across all countries. 4. Analyst Consensus value forecast coverage Analyst Consensus forecasts represent global sales across all countries. 5. Analyst Consensus volume forecast coverage Analyst Consensus forecasts represent global volume sales across all countries. Updates 1. Sales Data MIDAS Sales data is updated each quarter approximately 10-12 weeks after the period end, or annually in April, depending on your subscription. 2. Company Information Company-reported sales data, financials and other information is updated quarterly. 3. Analyst consensus Analyst Consensus value and volume sales data updated quarterly. PIPELINE DATA Data Source(s) / Report Description / Definitions / Coverage / Updates / MIDAS Panel Coverage / Disease Module: Medical Panel Coverage / Exchange Rates / Methodology Data Source(s) IMS LifeCycle R&D Focus Report Description The 3 widget view provides a view on all three pipeline widgets; Phase list, Phase count and Bulls eye. Each of these widgets are expandable by clicking the maximise /minimize button. The grid shows all active products in development for the current drug, company, or therapy class. Definitions 1. Pipeline Product Name Identifies the pipeline product name of the product being developed. 2. Corporation Identifies the corporation involved in the development of the drug. The number next to the corporation reflects the number of other companies involved in the development of that product (for that phase and for that indication), and mousing over this number reveals a the full list of these company names. 3. Indication A description of the likely medical use of a drug - using standard terms. 4. Development Stage This refers to the phase of development reached by the drug anywhere in the world. Phases can be as follows: Discovery - These relate to drugs for which no lead compound has been identified and pre-clinical evaluation has not yet begun. This will include all early stage collaborative agreements, drug discovery agreements, target-based screening programs and collaborations, gene discovery programs. The drugs will move to pre-clinical phase, once a lead compound enters pre-clinical studies. Preclinical - covers early research, as well as in vitro and in vivo studies. Drug design technologies and delivery systems are also defined as preclinical. Clinical - is a general term we use when the company refers to the drug as being in clinical trials but they don't specify if it is in phase I, II or III. It has the same status as phase I in terms of the search strategy. Phase I - small-scale, early human studies, covering drug safety, pharmacokinetics and dosage. Usually conducted in healthy volunteers, or, in the case of antitumor agents, in terminal cancer patients. Phase II - small-scale human studies, to evaluate safety and efficacy, and monitor sideeffects. Conducted in patients with the relevant disease or condition Phase III - large scale efficacy studies, often blinded and placebo-controlled, used to compile data for submission to regulatory bodies, e.g. FDA (USA), EMEA (Europe). Pre-registration - submission for approval to regulatory authorities Registered - approval for marketing by regulatory body. Marketed - available on markets Coverage Global Updates 1. R&D Focus Data The R&D information is updated daily. LAUNCH DATA Data Source(s) / Report Description / Definitions / Coverage / Updates / MIDAS Panel Coverage / Disease Module: Medical Panel Coverage / Exchange Rates / Methodology Data Source(s) All launch data is based on IMS MIDAS launch dates. Report Description The 3 widget view provides a view on all three launch widgets; Timeline, Timeline count and sales by launch year. Each of these widgets are expandable by clicking the maximise /minimize button. The grid shows launch dates by country for every product for the current drug, company, country or therapy class. Definitions 1. International Product Name For products on the market, IQVIA consolidates the various brand names used in different countries. Usually this is the ‘commonly used’ name or the name from the country of first launch. Products are consolidated under one name if 2 out of 3 of the following match: product name, corporation, and active ingredient. When a product cannot be grouped in this way with any other products internationally it is identified with an "@" symbol along with the country it is available in. In the case where a ‘generic name’ is used, an abbreviation of the owning company’s name is added, where it is known. For drugs of this type consolidated under one name, the 3 out of 3 of the following criteria must match: product name, corporation, and active ingredient. 2. Local Product Name The local product column shows the product name as it appears on the pack in a specific country. Products marked with a chevron ">>" indicates a parallel import 3. Country The country covered by the report. Note that not all channels of distribution are covered in all countries. Please see the channel to see which distribution channels by country are covered. 4. Corporation The Corporation column represents the corporations which have sales for the product within MIDAS data. The primary corporation which is specified in the grid is the corporation with the highest sales for the product in MIDAS data. If the corporation has a + sign followed by a number, for example +10, hovering over the +10 reveals a list of 10 other corporations which also have sales for this product in MIDAS data. 5. Local Manufacturer A local manufacturer is the local operator responsible for the selling and marketing of a product within that country. 6. Generic / Non Generic The generic product classification is based on the market segmentation generic product classification derived from MIDAS which assigns each local product to one of six categories: Biocomparable Products, Early Entry Generic Products, Non Generic products, Generic Products, Other Products and Non Categorized products. This classification currently covers the 33 countries outlined in coverage. Sales for all other countries are assigned to Non categorized products category. 7. Launch Date Generally this is the month and year that the product first appeared in an IMS audit and can vary from the marketing approval date due to various factors such a pre-stocking or delayed launches. For very recent or very old launches the date may not yet have been coded and has a past unknown launch date. A break down of what the launch date indicates by country is as follows: Country ALGERIA ARGENTINA AUSTRALIA AUSTRIA BANGLADESH BELGIUM BRAZIL BULGARIA CANADA CENTRAL AMERICA CHILE CHINA COLOMBIA CROATIA CZECH REPUBLIC DENMARK DOMINICAN REPUBLIC ECUADOR EGYPT ESTONIA FINLAND FRANCE FRENCH WEST AFRICA Date from which Date of launch sales first begin to Other by manufacturer accumulate √ √ √ Date of product licence grant √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ GERMANY GREECE HONG KONG √ √ √ Date when the Ministry of Welfare officially published price of the product HUNGARY INDIA INDONESIA IRELAND ITALY JAPAN JORDAN KOREA KUWAIT LATVIA LEBANON LITHUANIA LUXEMBOURG MALAYSIA MEXICO MOROCCO √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Date when the Pharmacy Organization (KNMP) officially issues the relevant code for a product NETHERLANDS NEW ZEALAND NORWAY PAKISTAN PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SINGAPORE SLOVAK REPUBLIC SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN THAILAND TUNISIA TURKEY UAE UK √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ URUGUAY USA VENEZUELA VIETNAM √ √ √ √ Coverage 1. MIDAS Audited Value, Volume, Kilogram and Patient Day coverage Figures are global aggregated totals from the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Central America, Chile, China, Colombia, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French West Africa, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, Uruguay, USA and Vietnam. Updates 1. Launch Data Launch data is updated each quarter approximately 10-12 weeks after the period end or annually in April, depending on your subscription. PROTECTION DATA Data Source(s) / Report Description / Definitions / Coverage / Updates / MIDAS Panel Coverage / Disease Module: Medical Panel Coverage / Exchange Rates / Methodology Data Source(s) All protection data is based on IMS MIDAS loss of protection dates. Report Description The 3 widget view provides a view on all three protection widgets; Timeline, Timeline count and sales by loss of protection year. Each of these widgets are expandable by clicking the maximise /minimize button. The grid shows loss of protection dates by country for every product for the current drug, company, country or therapy class. Definitions 1. International Product Name For products on the market, IQVIA consolidates the various brand names used in different countries. Usually this is the ‘commonly used’ name or the name from the country of first launch. Products are consolidated under one name if 2 out of 3 of the following match: product name, corporation, and active ingredient. When a product cannot be grouped in this way with any other products internationally it is identified with an "@" symbol along with the country it is available in. In the case where a ‘generic name’ is used, an abbreviation of the owning company’s name is added, where it is known. For drugs of this type consolidated under one name, the 3 out of 3 of the following criteria must match: product name, corporation, and active ingredient. 2. Local Product Name The local product column shows the product name as it appears on the pack in a specific country. Products marked with a chevron ">>" indicates a parallel import 3. Corporation The Corporation column represents the corporations which have sales for the product within MIDAS data. The primary corporation which is specified in the grid is the corporation with the highest sales for the product in MIDAS data. If the corporation has a + sign followed by a number, for example +10, hovering over the +10 reveals a list of 10 other corporations which also have sales for this product in MIDAS data. 4. Local Manufacturer A local manufacturer is the local operator responsible for the selling and marketing of a product within that country. 5. ATC IMS use the hierarchical Anatomical Therapeutic Classification (ATC) standard. It is a way of grouping, and therefore a way to look at, similar products. At its broadest level the system classifies products according to the parts of the body that they are used to treat. At the lower levels it uses therapeutic use, indication, mode of action, pharmacology etc. to define sub groups. Classes consist of a description and/or code. Both are used throughout this service. Code Description Level A Alimentary Tract and Metabolism Level 1 A2 Antacids, Antiflatulents and Antipeptic Ulcerants Level 2 A2A Antacids, Antiflatulents, Carminatives Level 3 A2A1 Plain Antacids Level 4 The EphMRA (European Pharmaceutical Market Research Association) Classification Committee originally prepared the Anatomical Therapeutic Classification Guidelines. More information can be found at www.ephmra.org. The primary objective of the Anatomical Therapeutic Classification is to satisfy the marketing needs of companies who are engaged in researching the pharmaceutical industry. Products are mainly classified according to their indications and use. Therefore it is possible to find the same compound in several classes; e.g. ibuprofen can be classified in M1A (Anti-rheumatic), N2B (Analgesic) and G2X (Other Gynaecological Products) if indicated for gynaecological conditions only. 6. Biologic / Non Biologic Data is categorized at a molecule level and then aggregated up to the following categories: Biologic product - If a product contains a Biologic molecule as the active ingredient (or a number of Biologic molecules are active ingredients) and there are no Non-Biologic molecules present as active ingredients then the product is defined as Biologic Product. Non Biologic Product - A product that contains only Non-Biologic molecule(s) as the active ingredient(s) is defined as a Non-Biologic Product. Bio/Non Bio Combi product - A product that contains both a Biologic and a Non-Biologic molecule(s) is defined a Bio/Non Bio Combi product. BIO-PRD Unknown - The category of BIO-PRD Unknown occurs only when the composition of all packs of a product are unknown. In such a case, with no known ingredients, the biologic status of the product's ingredients cannot be determined. IMS uses the following defining characteristics to categorize a biologic: Molecular structure - Biologic molecules are complex macromolecules, typically with some form of polymer structure. Specific macromolecules included in this definition are proteins, nucleic acids and carbohydrates. Molecular Identification - Biologic molecules must be clearly identified. Any 'molecule' where the molecule name is descriptive and the actual composition of the molecule is not identified (e.g. Vegetable Extract) will not be classified as a biologic. Active Substance - Biologic molecules must be, or are intended to be clearly defined active therapeutic ingredients in a product. Regulatory - Biologic molecules must have undergone (or be undergoing) a regulatory human clinical trial programme under the auspices of a national / regional regulatory authority. 7. Loss of Protection Date Provides IMS estimate of when the product will no longer be protected from generic competition. The following consideration are taken in determining the expiry date: Patents, SPCs (Supplementary Protection Certificate), CPCs (Complementary Protection Certificate), Data exclusivity, Marketing exclusivity, Delivery device patents, composition patents, Orphan drug status, Paediatric exclusivity, Paediatric patent extensions & known on-going litigation. Protection expiry date unknown and past: -Original and Licensed Brands with early launch dates, launched in countries where patent protection was known to exist but little or no patent information is available, are assumed to have been protected at the time of launch if it can be demonstrated that patents existed in a similar market at that time. In this situation the product would be coded with a protection expiry date of unknown past. Protection expiry date unknown and future: -Products that are known to be currently protected but for which the protection expiry cannot be accurately predicted. For example, recombinant or other high technology products where complexities in the manufacturing and approval processes add an extra deterrent to competitors on top of patents, exclusivity etc. In this situation a product would be coded with a protection expiry date of Unknown future. Coverage 1. Protection Coverage Dates & figures are from the following countries covered by MIDAS market segmentation coding: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, United Arab Emirates, Uruguay, USA, Venezuela and Vietnam. Updates 1. Protection Data Protection data is updated each quarter approximately 10-12 weeks after the period end or annually in April, depending on your subscription. DEALS DATA Data Source(s) / Report Description / Definitions / Coverage / Updates / MIDAS Panel Coverage / Disease Module: Medical Panel Coverage / Exchange Rates / Methodology Data Source(s) IMS PharmaDeals Report Description This sub tabs shows all merger & acquisition deals as well as any divestment deals related to the current drug, company, country or therapy class. Definitions 1. Acquiring Company Identifies the company acquiring the target company 2. Target company Identifies the company targeted for acquisition 3. Product Identifies any specific product in the target companies portfolio which is linked to the drug, therapy, company or country hub page you are on. 4. Product Description Provides a description of the product type from the following categories: Biomarkers Any transaction relating to a naturally occurring molecule, gene or characteristic by which a particular pathological or physiological process or disease can be identified. Companion Diagnostic Any transaction relating to a diagnostic that provides information that is essential for the safe and effective use of a corresponding therapeutic product. Includes diagnostics to identify patients who are most likely to benefit from a particular therapeutic product, diagnostics to identify patients likely to be at increased risk for serious adverse reactions as a result of treatment with a particular therapeutic product and diagnostics to monitor response to treatment for the purpose of adjusting treatment (e.g. schedule, dose) to achieve improved safety or effectiveness. Diagnostic Any transaction relating to products or technologies involving the determination of cause or confirmation of an illness. Drug Delivery Technology Any transaction relating to products or technologies involved in the delivery of drugs to the body. Includes gene delivery. Evidence-based Research Any transaction relating to evidence-based research to inform pharmaceutical R&D and/or improve the treatment of disease. Includes comparative effectiveness studies. Manufacturing Technology Any transaction relating to technologies involved in the manufacturing of therapeutics, diagnostics, medical devices or vaccines. Medical Device Any transaction relating to products or technologies that are used as a device within the medical industry. Includes biomaterials, lab equipment, monitoring devices, surgical devices etc. OTC Any transaction relating to products or technologies that are sold over the counter. Protein engineering Any transaction relating to products or technologies for the engineering of the structure of proteins so as to produce desired properties, or the synthesis of proteins with particular structures. Includes antibody fragments, bispecific antibodies, antibody-drug conjugates and engineered proteins with novel amino acids. Research Technologies Any transaction relating to technologies involved in research. Sub classified, including for cell lines, assay detection, DNA, proteomics and bioprocessing. Software/ Bioinformatics Any transaction relating to products or technologies that involves the use of computers in solving information problems in the area of life sciences. It mainly involves the creation of electronic databases of genomes and protein sequences, and techniques such as the threedimensional modelling of biomolecules and biological systems. Includes in silico operations. Therapeutic Biological: Any transaction relating to products or technologies made from a living organism or its products and is used in the prevention, diagnosis or treatment of cancer and other diseases. Sub-classified, including antibodies, cell therapy, stem cells, hormones, nucleotide-based and peptides. Gene Therapy: Includes all aspects of gene therapy and any research relating to the structure or function of specific genes. Generic: Generic versions of patent-expired medicines. These may or may not have their own brand names. Natural Product: Any transaction relating to products or technologies involving compounds that occur naturally in living organisms. Includes extracts. Radiopharmaceuticals (Therapeutic): Any transaction relating to therapeutic products or technologies that involve radioactivity. Small Molecule: Any small molecule, i.e. a non-polymeric bioactive molecule that is not a peptide/protein, DNA/RNA or complex carbohydrate. Includes synthetic or foreign chemicals (xenobiotics) and vitamins and minerals. Vaccine Includes therapeutic and prophylactic vaccines, and vaccine and immunotherapeutic adjuvants. 5. Deal Title Title of the deal provides a brief description of the deal. 6. Total Deal Value (US$M) The dollar value of the deal. 7. Deal Number The deal number in the PharmaDeals database. Coverage Global Updates 1. PharmaDeals This is updated weekly. FAQs What can we get the latest year data e.g. 2020? • According to IQVIA – latest year data will provisionally be available in late March • From our GC IS healthcare expert: April – May 2021 would be more possible according to previous year’s timeline Are we able to get quarterly data for IQVIA? • No, data is annual only • Bain only subscribes to annual data – quarterly will have to be a separate ad hoc purchase. Do we have full access to the Oncology module? • The country-level data is limited in the Oncology module. In the Oncology module we can see total tumor-sales split by country, but not drug x tumor x country sales splits. • There is the Enhanced Oncology Module that enriches the data available from the standard Oncology Module that offers country-level data across all dimensions in Analytics Link and in the Query Builder. Bain does not subscribe to this enhanced module. Can we get older data (more than 5 years)? • IQVIA will not sell to Bainas they consider us their competitors • Case teams can purchase through clients if required How do I calculate Sales Level Implied Price per Standard Unit? • You can calculate this by running both value and volume extracts and calculating the factor between the two to derive the implied price. • Sales Level Implied Price per Standard Unit = Value / Volume How can we determine the size of the biosimilars market? In the Query Builder, we can use the below segments: Query Builder Segments Country China Biologic / Non-Biologic BIOLOGIC PRODUCTS BIOCOMPARABLE PRODUCTS, EARLY ENTRY GENERIC PRODUCTS, Generic / Non-Generic GENERIC PRODUCTS How does the order of the level in Query Builder affect the output? In Query Builder the items that are displayed are based on the top 20 visible items based on the preceding layers. List 1: Therapy(ATC1) Therapy(ATC2) Pharmaceutical Molecule Name International Product Name Corporation List 2: Therapy(ATC2) Therapy(ATC3) Pharmaceutical Molecule Name International Product Name Corporation In List 1, for pharmaceutical molecule name, you will see the top 20 pharmaceutical molecule names for each ATC2 code. In List 2, you will see the top 20 pharmaceutical molecule names for each ATC3 code. Because ATC3 is more granular than ATC2, that means there are more pharmaceutical molecule names visible in report 2, and in turn – in the fifth level of the report – more companies visible. However, many items are displayed, the rows (e.g. companies) that are not listed individually have their sales reported under ‘other’ so the totals still match. What is the difference between Euro vs LC Euro or US Dollars vs LC US Dollars in the Query Builder? • LC Euro or LC US Dollars is based on a constant exchange rate e.g. 2020 exchange rate used on 2019 to 2020 data • Euro or US Dollars is based on the exchange rate of that particular year e.g. 2016 will use the exchange rate of 2016, 2017 will use the exchange rate of 2017 TO TAKE NOTE • IQVIA data is manufacturer selling price collected from a pharmacy and hospital audit. This data does not match company net sales and does not take into account discounts. • We only have 5 years of historic IQVIA data. We have analyst consensus forecasts based on net sales but they do not match the historic data. • We only have the channel split for pharmacy and hospital. Online data is not covered and would need to be purchased. • The data covers Prescription (Rx) and OTC but not all OTC. o We do not have a split for Rx/OTC. Could be maybe 70% Rx and 30% OTC – but it varies by category. o Bain had a trial to their OTC module in 2019 but we didn’t think their OTC data was very good • We only have brand level data and would need to purchase SKU level data.