Medicinal cannabis in Germany - Business Report

12 Confidential __________________________________________________________________________________ III List of figures Figure 1: Cascade of active substances in the Cannabis plant ....................................................................... 17 Figure 2: The entourage effect........................................................................................................................ 18 Figure 3: Indications, prevalence and market ................................................................................................ 20 Figure 4: Patient ID of the company CANNAMEDICAL ................................................................................... 29 Figure 5: Regulatory triangle of medicinal Cannabis ...................................................................................... 30 Figure 6: The Cannabis market by product class and corresponding sub-markets ....................................... 32 Figure 7: Example of consumer products containing Cannabis ..................................................................... 37 Figure 8: Cannabis prescribers ........................................................................................................................ 38 Figure 9: Market penetration curve for prescribers and patients ................................................................. 39 Figure 10: Cannabis prescriptions by group of specialists.............................................................................. 50 Figure 11: Frequency of Cannabis drugs used ................................................................................................ 51 Figure 12: Reasons for discontinuing Cannabis therapy ................................................................................ 51 Figure 13: Stakeholders in the Cannabis market in Germany ........................................................................ 53 Figure 14: Cannabis organisation at BfArM.................................................................................................... 53 Figure 15: Interaction of national and regional monitoring institutions ....................................................... 59 Figure 16 Development of exemption permits from 2005 to 2016 ............................................................... 64 Figure 17: Development of applications for cost coverage since 2017 ......................................................... 66 Figure 18: The Cannabis market in Germany in 2018 .................................................................................... 89 Figure 19: Development of finished medicinal products and formulations from 2018 to 2019................... 91 Figure 20: Development of finished medicinal products and pharmaceutical preparations, 2018-2019 .... 91 Figure 21: Proportion of Cannabis prescriptions by medical specialty .......................................................... 94 Figure 22: Cannabis prescriptions of physicians by specialisation in the second quarter of 2019 ............... 95 Figure 23: Changes in Cannabis prescriptions from 2018 to 2019................................................................. 96 Figure 24: Prescriptions of Sativex® and Canemes® from 2014 to 2019 ....................................................... 98 Figure 25: Development of the Sativex and Canemes Regulations, 2018 to 2019........................................ 99 Figure 26: Sativex and Canemes revenues (ApU) from 2018 to 2019 .........................................................100 Figure 27: Sativex and Canemes revenues (AVP) from 2018 to 2019..........................................................101 Figure 28: Procedure in the AMNOG process...............................................................................................103 Figure 29: Pharmacy purchases of Cannabis products 2018 to 2019 ..........................................................105 Figure 30: Pharmacy purchases of Cannabis products 2018 to 2019 ..........................................................106 Figure 31: Pharmacy purchases of Cannabis products in ApU from 2018 to 2019 .....................................107 Figure 32: Development of the number of suppliers of Cannabis flowers from 2017 to 2019...................108 Figure 33: Pharmacy purchases of Cannabis flowers in the second quarter of 2018..................................109