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Biotest AG Investor Presentation 2018

Nov 14, 2018

66_rns_2018-11-14_f9beee59-7844-4cc2-bc12-aa7c9ae9549d.pdf

Investor Presentation

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Biotest AG

Analyst call - Nine months 201814 November 2018

Disclaimer

  • • This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and asset situation of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and thus are subject to risks and elements of uncertainty that could result in deviation of actual developments from expected developments.
  • • The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.
  • • All figures reported relate to the Continuing Operations of the Biotest Group, if not specified otherwise. After the sale of all US subsidiaries, these activities are being reported as Discontinued Operations. The previous year´s figures have been adjusted accordingly.
  • • All comparative figures relate to the corresponding last year´s period, unless stated otherwise.

Biotest Group: Q1 – Q3 2018 at a glance

  • • Sale of two US subsidiaries incl. the US Plasma collection centres to GrifolsShared Services North America, Inc., a subsidiary of Grifols S.A., Barcelona, Spain for US\$ 286 m completed
  • • Sales proceeds used to repay bank debt and promissory notes
  • • Sales of Continuing Operations in Q1-Q3 2018 at € 289.6 m (+ 10.1%) vs. € 263.0 in Q1-Q3 2017
  • •EBIT in Q1-Q3 2018 at € 5.1 m
  • •Biotest Next Level project progressing

Sales development

(€ million)

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Sales by region(€ million)

EBIT by segment(€ million)

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*: Other segments include merchandise and corporate costs not allocated to Segments, for instance cost for re-alignement (Creat)

EBIT reported and adjusted(€ million)

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*: The R&D costs for those products that can be produced only at the new plant are part of Biotest Next Level costs

Biotest Next Level costs

(€ million)

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*: The R&D costs for those products that can be produced only at the new plant are part of Biotest Next Level costs

Income statement

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*: thereof € 8.5 m prepayment expenses

Biotest Continuing Operations after divestment of US assets

Use of the proceeds from sale of plasma centres (€ million)

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Status financing as of 30 September 2018 (€ million)

Balance sheet (Continuing + Discontinued Operations)(€ million)

Cash flow from Continuing Operating activities 2018(€ million)

Cash flow:working capital (€ million)

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Update Creat – Shanghai Raas

  • • Shanghai Raas has publicly announced to initiate a capital increase against cash and contribution in kind. Creat will contribute Tiancheng as contribution in kind. Other shareholders will acquire new shares against cash. These cash proceeds may be used for future investments into Biotest and BPL
  • • During this process, (to be completed in HY1 2019), Biotest AG (the "underlying asset" of the contribution in kind) may not be changed or adjusted
  • • A decision about the future structure of Tiancheng's European entities will be taken earliest in 2ndhalf of 2019

Biotest Next Level update

August

• Integration of an innovative, technologically leading system for virus inactivation into the production process

September

• Operational qualification of major equipment completed

IgG Next Generation (IVIG)

  • • Development of successor of Intratect® helps patients withimmune system dysfunctions and some autoimmune disorders
  • •Global commercialisation planned
  • •New efficient production process with high IgG yield established
  • •"Master product" for the Biotest Next Level production plant

Clinical development

  • Phase III study in PID* (EU + US): recruitment of adults completed –recruitment of children almost completed (~ 01/2019)
  • Phase III study in ITP** (EU): recruitment of patients nearly completed (~12/2018)
  • •Phase III study in CIDP*** (USA + EU): study design in discussion with FDA

*: Primary Immune Deficiency; **: Idiopathic Thrombocytopenic Purpura; ***: Chronic Inflammatory Demyelinating Polyneuropathy, or other neurological indication

Trimodulin and Fibrinogen

Trimodulin:

  • •Preparations currently under way to start the phase III trial
  • • FDA and PEI feedback on quality of production process and preclinical project status
  • •Very positive feedback on clinical programme
  • Communication with experts and scientific advices lead to a clear development path for the project

Fibrinogen:

a) Congenital fibrinogen deficiency: phase I/III clinical trial (no. 984) ongoingEMA approved the paediatric development plan to treat children under 6 years of age in this study

b) Acquired fibrinogen deficiency: phase III clinical trial "ADFirst" (no. 995)ongoing

Research & development projects to market (overview)

*: Primary Immune Deficiency; **: Idiopathic Thrombocytopenic Purpura; ***: Chronic Inflammatory Demyelinating Polyneuropathy, or other neurological indication

Plasma sourcing after divestment of US plasma donation centres

Accelerated expansion in Europe ongoing

  • •A new centre will be acquired in Germany
  • • 4 new centre in 2017(Prague, Székesfehérvár, Debrecen, Kaposvár)
  • 2 new centre in 2018 (CZ) (Břeclav, Brno)

Marketing & sales activities

Biotest is supporting Shanghai RAAS in selling first Shanghai Raas product in Hungary

  • First cooperation with Shanghai RAAS on a European level
  • •Gammaraas (Liquid 5% IVIG) from Shanghai RAAS
  • •first patient successfully treated with Gammaraas on 1 October 2018

Guidance 2018

  • •Increased demand for immunoglobulins worldwide (price and volume increases)
  • •Considerable uncertainties in key markets due to political uncertainties
  • EBIT guidance unchanged (€10 to 12 million)

  • •Continued focus on Biotest Next Level

  • •Opening of new plasma collection centres in Europe

Financial Calendar 2019Contact

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