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1 ALVOTECH 2017

2 ALVOGEN

3 ALVOGEN WORLDWIDE 35 Alvogen worldwide offices

4 BIOPHARMACEUTICALS ARE THE FUTURE Biologic molecules are the future of the pharmaceutical industry due to type of diseases it treats and precision of targets. 8 of top 10 products worldwide are biologics and by 2016, 45% of top 100 drugs sales will come from biologics Around 50% of new industry launches are biologic products. Biologic innovator molecules costs make extreme pressure on reimbursement systems. By 2020, USD100 billion market value of biologic molecules going off patent. Cost per patient USD to per year the world is waiting for a solution! Biologics are seen to be a significant driver of rising healthcare costs - leading to intense interest in biosimilars

5 THE ALVOTECH ALVOGEN ALLIANCE Alvogen is already strong in the biosimilar marketing field, with three biosimilars playing a market leader role in CEE and many others under registration in CEE and APAC Alvogen sales force will ensure Alvotech product commercial presence in all Alvogen countries. Alvotech out-licensed to partners in other geographies. Alvotech pipeline will provide Alvogen with a pipeline of monoclonal Antibody biosimilars for 7 leading biologic molecules Alvotech to leverage from Alvogen s infrastructure and resources

6 OVERVIEW Alvotech is dedicated to be one of the leaders in the monoclonal antibody market Alvotech is investing $500 million in a new state-of-the-art biotech plant and pipeline The building of a biosimilar API and filling plant in Iceland is completed and validation of facilities, utilities, manufacturing and analytical equipment is abbot 90% done. First seven molecules under development and further portfolio selection on going first products to be launched 2020 Alvotech is offering partnership and licenses for its product portfolio worldwide Alvotech is an independent sister company of Alvogen

7 HIGHLIGHTS 2013 HIGHLIGHTS 2014 HIGHLIGHTS 2015 HIGHLIGHTS HIGHLIGHTS Alvotech founded by Robert Wessman as an independent sister company of Alvogen Development partnership with Swiss based company for the first 2 mab biosimilars Breaking ground on a 12,000 square meters biomanufacturing facility in Reykjavik, Iceland Strategic investments in Baliopharm and Glycothera to increase development capabilities Initiation of development of next 2 Mab biosimilars, bringing pipeline to 4 Mabs New partnership agreement with global pharma company New Program included in global partnership, initiation of development of next 2 Mab biosimilars, bringing the pipeline to 6 Mabs Facility Inauguration 7 product pipline

8 Reykjavik ~100 FTE s Fully integrated value chain under single leadership From clone to dossiers targeting global markets SITE JULICH Cell-line/Process development, and Analytics Specialization in clone creation and selection and the establishment of a process designed to tailor and control product characteristics SITE ZURICH Highly Experienced, Strategic Clinical, Regulatory and IP Fast-to-filing based on superior product knowledge, aggressive clinical approach and ongoing interactions with global regulatory agencies SITE HANOVER World-class Glyco-analysis Capacity More than a decade of experience and know-how in the highly specialized area of Glyco-characterization SITE REYKJAVIK Pharmaceutical Sciences Embedded with Manufacturing Process scale-up and reproducibility to ensure seamless transfer and fit to commercial scale manufacturing. Hanover ~ 20 FTE s Jülich ~ 50 FTE s Zurich ~ 30 FTE s

9 OUR INITIAL APPROACH Develop a pipeline of 6 biosimilar Monoclonal Antibody for key molecules WW, through a fully integrated development and manufacturing organization for Biosimilars Build a state-of-the-art biosimilar production, fill and finish facility, to develop and produce the products Creation of Alvotech Alvogen Alliance and use Alvogen sales and marketing network in more than 34 countries to sell and distribute the products Out licensing to local players in key markets where Alvogen does not have a presence Aim to cover all territories where the innovator has market share

10 ICELANDIC FACILITY

11 WHY ICELAND? IP environment enabling launch of products anywhere in the world the moment the patents expire in any given region or country. Local funding available for facilities and working capital Iceland is part of the EMA regulatory system Located between East and West for easy market access and supply world wide Talent pool of educated professionals and scientists Renewable Energy at favorable cost

12 A new facility in the industry for drug substance manufacturing and filling of biopharmaceuticals State-of-the-art, multiproduct, flexible biopharmaceutical facility in Reykjavik Iceland, officially inaugurated in June ,278 square meters facility and laboratories A blend of 1KL and 2KL disposable fermentation tanks for mammalian cells Drug Substance production, for a total capacity of 16,000L Aseptic filling and finishing lines for vials and prefilled syringes cgmp manufacturing capacity for clinical and commercial scale facility FDA/EMA GMP standards

13 OPERATIONAL 2017 Facility includes R&D capacity, API manufacturing and filling plant fully operational L and 2000L Disposable fermentation technology for mammalian cells API production. Relatively high yield fermentation and downstream process (state of the art Biosimilar production processes). DSP: using non-disposable squids, columns and final filtration units; separated rooms for pre, low and post-virus

14 PLANT OUTPUT Plant output at DSP of 5 Kg in 2017 phasing in to 325 Kg in 2025 on 4 x 1000 L and 6 x 2000L fermentation reactors. 3 million pack units per year at max capacity in vials, prefilled syringes and pens. Aseptic filling - Fill and finish lines for vials, prefilled syringes, cartridges. Semi automatic assembly lines for auto-injectors (Pens)

15 BASEMENT LAYOUT

16 BASEMENT Warehouse: Controlled ambient, 2 to 8 o C and -65 to -55 o C storage. Small GMP warehouse sized for 2 to 4 weeks stock at full production, raw materials, consumables, primary packaging materials, API and drug product. Utilities: purified water, water for injection, pure steam, compressed air, gases Waste decontamination and temporary storage

17 FIRST FLOOR API MANUFACTURING

18 FIRST FLOOR 2 API suites each with dedicated: Media preparation Buffer preparation Inoculum culture rooms Downstream processing suites API-1: 4x1000L and 2x2000L cell culture trains API-2: 4x2000L cell culture trains Based on closed systems and single use technology throughout with the exception of: Tangential flow filtration unit (TFF) not available as single use unit at required scale CIP & SIP Purification columns which are product dedicated

19 MEZZENINE FLOOR LAYOUT Layout Primary change rooms and technical space

20 SECOND FLOOR LAYOUT

21 SECOND FLOOR DRUG PRODUCT MANUFACTURING Shared preparation area: Equipment washing area Pass through washing machine Clean equipment store Weighing room for excipients Separate vial filling suite and syringe filling suite each with: Dedicated change room Compounding room with formulated bulk transferred through wall into filling room Pass through autoclave and VHP MAL Filling lines enclosed by RABS Filled, stoppered and oversealed vials transferred through wall to vial coding and inspection room Filled and stoppered syringes transferred through wall to syringe labelling and inspection room Separate manual inspection room On plant offices

22 PLANT FACTS cgmp manufacturing capacity for clinical and commercial scale. FDA/EMEA GMP compliant. Detailed design review completed for both authorities, without any major or critical observation Full capacity to test and release in GMP laboratories. Collaboration with University of Iceland

23 UNIVERSITY OF ICELAND CAMPUS Alvotech in The science park

24 decode Alvotech

25 Askja University of Iceland

26 GAS

27 COPRESSED AIR

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29 EFFLUENT TANKS

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31 SMART FACTORIES Alvotech Production Facility Reykjavik, Iceland (2015/2016) 6 x 2000L, 4 x 1000L, in 2 suites, single-use/hybrid Two bio-similar drug products initially with further in pipe-line Finesse s project deliveries: Process Equipment Full automation Manufacturing Execution System (MES) Full validation All new equipment purchased

32 Objective review of process requirements: automate only necessary unit operations other steps can be added later Modularize USP/DSP suites with option of pooling materials accept 2000L and DSP process limitations Invest in flexible technologies: SMARTparts, movable workstations (terminal services), flexible core buildings Mix-and-match vendors: use best-of-breed equipment Consider Universal Controllers: better negotiating position for consumables with multiple qualified sources

33 INTRODUCTION TO ALVOTECH: PROCESS Manufacturing process based on platform technology using: CHO cell lines 1000L & 2000L scale cell culture in single use bioreactors (SUB) Harvest and 3 column step purification supported by single use mixers (SUM) and bags Formulation Filtration Filling into vials and syringes Inspection Packing

34 API PROCESS OVERVIEW Inoculum expansion Production cell culture Harvest Purification Dispensing Freezing

35 2000L CELL CULTURE PROCESS 100L seed SUB Batch 1 Batch 2 500L seed SUB 2000L production SUB 2000L production SUB

36 HARVEST PROCESS 2 x 2000L production SUBs 2 x MVP & STAX Filtration units 2 x 2500L SUM pool tanks

37 PURIFICATION PROCESS Protein A Virus Inactivation Cation Exchange 500L SUM Freze/thaw Tangential flow filtration Nano filtration Anion Exchange

38 DRUG & FINISHED PRODUCT PROCESS OVERVIEW Compounding Sterile Filtration Aseptic Vial Filling Aseptic Syringe Filling Batch Coding Inspect Label Secondary Packing

39 SMARTSYSTEMS: UNIVERSAL SOFTWARE Universal Finesse Software Network for Upstream and Downstream Operator Station Professional Plus Station Application Station and Historian OPC SERVER TruBio SCADA interface = control and monitor any OPC Compliant equipment Plant LAN DV Controller DeltaV Network OP C Finesse T300 Controller for Glass and SmartRocker Third Party Controllers: Sartorius/Applikon upstream or Palll/GE downstream TruBio native interface = control and monitor any Finesse or DeltaV equipment OP C Analyzers: Nova 100, 300, 400, BioProfile Flex Any OPC Compliant Instruments/Equip ment One common user interface with remote capability Unified process recipe + off-line analytics database Finesse offers market-leading SW features on a cost effective DeltaV platform DeltaV Software and Network TruBio, TruPur and TruChrom Cost effective DeltaV licensing Both native DeltaV and SCADA versions Modbus comms standard (lowest DST) Fieldbus, Profibus or DeviceNet available TruBio/TruPur/TruChrom features Commercial Off The Shelf (COTS) Highly configurable and expandable Sophisticated control algorithms Parameter update in real-time Sensor redundancy and calibration

40 UNIVERSALITY (USP EXAMPLE) Agitator Physical: outside the bag Defined by bioreactor vendor Bioreactor vessel Differences: agitation, weight (load cells) thermal jacket design Universal Controller VAB TCU Vessel Process Weight Process: inside the bag Defined by end user Sensors: ph, DO, P, T, etc. Actuators: liquids + gases Thermal Control Similarities: automation / control algorithms Universal Controller Concept: Ability to control ANY vessel type with the SAME controller Vessel Adapter Box accounts for physical differences in bioreactors

41 TRUBIO 5.0 Simplified and modernized look Multi-feed feature is perfusion capable out-of-the-box Harvest feature option out-of-the box Flexibility allows rapid configuration for custom apps

42 DOWNSTREAM HARMONIZATION Phase 0: OPC connection Phase 1: SmartSwitch Phase 2: Universal Controllers native native native native native native native native OPC OPC OPC OPC OPC OPC

43 FINESSE TRUPUR SOFTWARE Flexible TruPur software code for filtration Applications include: harvest, virus filtration/inactivation, clarification, and TFF Flexibility allows rapid configuration for custom applications

44 FINESSE TRUCHROM 2.0 SOFTWARE Flexible DeltaV code for Chromatography General functionality based on Unicorn (leading product) Next generation will be fully configurable Flexibility allows rapid configuration for custom applications

45 LEVEL 3: SMART MES SmartFactory is Pre-validated skidded solution that is production ready and ERP capable, that allows the operations team to: 1. Stop deviations before they occur 2. Ensure that correct resources are involved such as: People Equipment Equipment Status Material Documents Work Instructions Data 3. Implement release by exception SmartFactory TruBio TruPur

46 KEY SUPPLIERS Working with leading equipment vendors: API: ThermoFisher upstream single use disposables GE downstream chromatography skids Pall down stream single use disposables & TFF skid F&F: Bausch and Ströbel - vial and syringe filling lines Getinge autoclaves Steris VHP material transfer rooms Finesse/Syncade: Smart Factory Automation of all skids using DeltaV Manufacturing execution system / EBR Materials tracking Equipment tracking 47

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48 SMARTFACTORY: FAT READY

49 Data Center + Workstations

50 Thermo mixers (50, 200, 500, 1000) PALL buffer prep mixers (50, 100) Product pool tanks will go directly Iceland

51 Thermo Bioreactors: 50, 100L, 250, 500, 1000, 2000 Dual Finesse SmartControllers on carts with HMI

52 3 skids: Protein A, Anion, Cation Column packing skid separate (Unicorn)

53 Clarification skid TFF skid is stainless steel (1 )

54 API FERMENTATION

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58 THANK YOU