Biotest AG

Company Presentation

June 2014

Company Presentation Biotest AG 0

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
All comparative figures relate to the corresponding last year s period, unless stated otherwise.

Biotest – Our mission

Innovation	• New drugs, new indications • Further development of authorised drugs
Quality	• Safety • Tolerability • User friendliness
Responsibility	• Patient benefit • Due diligence • Long-term view

Highlights first quarter 2014

Biotest headquarters in Dreieich

Sales of € 122.2 million, an increase of 2.9% vs Q1 2013
Position in the US market strenghthened, internationalisation driven forward
Capacity expansion project "Biotest next level" is progressing well
Positive development of R&D projects

Biotest Group

Headquarter in Dreieich/Germany (Frankfurt area)
Subsidiaries in 11 countries worldwide
Employees (FTE)*: 2,090 Thereof 59% located outside Germany
Founded in 1946, IPO in 1987, SDAX in 2007 (preference shares)
Biotest shares:
6,595,242 ordinary shares
6,595,242 preference shares

Headquarter, Dreieich

*: as of March 31, 2014

Biotest: History and milestones achieved

Focus of Biotest

Biotest is a pharmaceutical company which develops, produces and sells biological medicinal products, that are either obtained directly from human plasma or manufactured using biotechnological methods.

Plasma Proteins business at a glance

Biotest Plasma Protein products

Intratect® market share in (GER+ AUT+ CH) = ~ 13%
World market leader with Cytotect® and Varitect®
Leading position with Hepatect® in Europe and Nabi HBTM in USA
Biotest covers full value creation chain: plasma sourcing, production, distribution
vertical integration leads to rationalisation and higher productivity

= Biotest products = lead indications

Plasma Proteins – Efficient production network

26 plasma collection centres
Level of self-sufficiency: 50% for standard plasma
Exchange of intermediate products from US to Europe from 2013 onwards
Network increases

* Production in Dreieich and capacities at partners

Financials Q1 2014

Sales in the first quarter 2014

Sales (€ million)

Sales increase in Germany 1.8%
Sales increase in Europe w/o Germany 11.5%
Sales in other countries stable

Earnings in the first quarter 2014

EBIT (€ million)

Lower Bivigam® sales after recall
Higher project cost for "Biotest Next Level"
Advanced clinical studies incured higher funding

Continue and accelerate growth

Biotest Group: sales 2004–2013 (€ million)*

Sales target for 2020:

~ € 1 billion

* On a comparable basis, excluding pharmaceutical activities

600

Position strengthened in the attractive US market

BPC headquarters in Boca Raton, Florida

Successful start to the marketing of Bivigam® in 2013
Sales forecasts for Bivigam ®
about US\$ 60 million for 2014
about US\$ 100 million p.a. from 2015 onwards
Number of plasma collection centres in the US will increase to 18 by the end of 2014
Promising development projects

Production network offers great advantages

Plasma collection in US collection centres, initial processing in Boca Raton 1 2 3

Processing into finished products, filling/packaging at Dreieich

Global marketing, including in the EU, China or South America

Entering additional growth markets

China: third largest pharmaceutical market in the world, two-digit growth rates
Marketing authorisation for Albiomin® 20% expected by Biotest for the fourth quarter 2014
Brazil: fifth largest country (by population) in the world
Rapidly growing market for plasma proteins
Marketing authorisation for Albiomin® 20% received in November 2013, further plasma proteins in the marketing authorisation procedure

Global market for immunoglobulins continues to grow

Global market volume for IVIG (tonnes)

Global market trend Immunoglobulin (SC/IVIG)

In the midterm, up to 2015 the following regional growth rates are expected: EU: 4-5%, USA: 4-6%, RoW: 12-13% CAGR
The global Immunoglobulin market is expected to grow with an average growth rate of ~5-6% p.a. in the period between 2012 and 2025.

Sources: Biotest Market Research based on MRB (2013) etc.

Per capita usage Immunoglobulins and Albumin 2012

Sources: Biotest Market Research based on MRB (2010-2013), PPTA (2012), IMS (2012)

Biotest Next Level: Investments in growth

Increase in global capacity to:

Plasma fractionation:

3.1 million litres per year

current: 1.5 million litres per year

Immunoglobulins:

13 tonnes per year current: 5.5 tonnes per year

Albumin:

72 tonnes per year

current: 42 tonnes per year

Programme for increasing capacity at Dreieich
Construction of new production facilities at the Dreieich location
Period: 2013 to 2018
Investment amount: > € 200 million
More than 300 additional jobs

A modular approach for a production building

Building(s) and equipment will be implemented stepwise in connection with the progress of the development products.

Location of capacity expansion Dreieich

First projects initiated or already completed

Completed multi-storey car park

Already completed:

Expansion of filling and packaging facilities
First expansion of albumin production
New multi-storey car park

Construction started:

Plasma goods receipt area
Virological test laboratory

Next steps:

Basic engineering completed in Summer 2014
Ground broken for new production building by the end of 2014

Timeline

Research & development Innovation Quality Responsibility

Biotest products and pipeline

New products at the horizon

Company Presentation Biotest AG

Clinical Immunology: Civacir®

Model of hepatitis C virus

Hepatitis C immunoglobulin for reinfection prophylaxis after liver transplantation
Very high demand:
Currently no reliable prophylaxis for the critical period immediately after transplantation
New virostatic drugs are not an option
In the EU and USA alone, more than 5,000 liver tranplants due to hepatitis C each year
Phase III study is underway; treatment of the first patients has already been completed

Intensive Care Medicine: IgM concentrate and fibrinogen

IgM concentrate

IgM concentrate for the treatment of sepsis
Unique mechanism of action
Over 100 patients treated to date in phase II study

Fibrinogen

Fibrinogen for the treatment of severe acute bleeding due to fibrinogen deficiency
Ready-to-use product is in development
First patients treated in phase I/II study

Monoclonal antibodies extend the range of products in the Clinical Immunology and Haematology areas

Haematology: Indatuximab Ravtansine (BT-062)

Targeted mechanism of action:

Antibody docks on cancer cell and toxin is then released:
Targets cancer cells while healthy cells are very largely spared
Clinical development in the lead indication multiple myeloma is continuing
Very convincing data from current phase II study
Partial to complete remission of the disease in about 75% of treated patients
Presentation of the data at the prestigious ASH conference encountered a great response

High efficacy in tumour treatment

Treatment of human breast cancer implanted in mice

Very high efficacy with a tolerable dosage in the treatment of solid tumours that do not respond to standard therapy
Tumours resolved completely within 14 days
No recurrence (renewed growth) after the end of the treatment, no metastases
Start of clinical development in breast and bladder cancer

High need and large sales potential

Indication focus of Indatuximab Ravtansine (BT-062)

* Anticipated potential patients / Source: Decision Resources 2013 for seven important markets, Biotest estimates

Clinical Immunology: Tregalizumab (BT-061)

Developed in the lead indications of rheumatoid arthritis (RA) and psoriasis
Treat 2b: phase IIb trial in RA started in autumn 2013
Largest clinical trial in Biotest history:
Over 300 patients
Over 70 trial sites in 14 countries
Final results in the first six months of 2015
Over half of the planned patients have already been included in the trial

Contact and Financial Calendar 2014

Investor Relations Biotest AG:	Financial Calendar 2014
Dr. Monika Buttkereit Head of Investor Relations	12. Aug 2014	Q2 Report 2014
Phone: +49 (0) 6103 - 801 -4406 Fax: +49 (0) 6103 - 801 -347 E-Mail: [email protected]	12. Nov 2014	Q3 Report 2014/ Analyst Conference