Biotest AG

Company Presentation

January 2015

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 Group: Q1-Q3 2014 at a glance

Biotest Q1-Q3 2014 sales up by 11.5% to € 409.9 m. Increase largely attributable to an increase in volume and sales in international markets w/o US
Q1-Q3 2014 EBIT decrease by 11.5% to € 35.3 m
Ongoing Civacir® Phase III study shows promising data in re-infection in liver transplantation patients
Recruitment of patients for study "Treat 2b" (BT-061) in Rheumatoid Arthritis completed
Biotest "Next Level" project is on track
Marketing authorization granted for Albiomin 20% in China in Oct. 2014

Biotest Group

Headquarter in Dreieich/Germany (Frankfurt area)
Subsidiaries in 11 countries worldwide
Employees (FTE)*: 2,137 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 Sept. 30, 2014

Shareholder structure

50.0% of total capital, and 100% of voting rights 50.0% of total capital, 0% of voting rights

* as of January 2015 based on notifications

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® (IVIG) market share in (GER+ AUT+ CH) = ~ 12%
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

27 plasma collection centres
Level of self-sufficiency: 60% for standard plasma
Exchange of intermediate products from US to Europe from 2014 onwards
Network increases

* Production in Dreieich and capacities at partners

Financials Q1-Q3 2014

Sales growth much stronger than expected

0 5 0 100 150 200 250 300 350 400 450 Q1-Q3 2013 Q1-Q3 2014 409.9 367.5 +11.5% Germany Rest of Europe North/South America Asia Other 119.7 117.4 69.6 130.1 97.6 9.4 70.6 16.2 70.2 76.6

Sales by region (€ million)

EBIT decrease

35.3 Increased costs for clinical trail material of € 4.0 m for BT-061 and Civacir® due to good progress in clinical studies
Unabsorbed costs in US due to slow down of production
Additional costs for the expansion plan "Biotest Next Level" of € 2.2 m

Earnings decrease

Positive exchange rates effect
Increased interest payments due to usage of additional credit lines

Financial position: strong equity base

Financial Position of the Biotest Group (€ million)

Strategy Market environment

Global IgG (i.v. + s.c.) Market Forecast

The global IgG market is expected to grow to over 200 tons by 2018.
Expected annual growth is highest in ROW countries.

Sources: Biotest Market Research based on MRB (2013),

Factors supporting growth of IgG and plasma products

Market expansion

Improvements in wealth and therapy reimbursement
Improving access to care

Physicians' Awareness

Awareness of treatment options and indications still low
Many patients are still undiagnosed

Demographic development

Growth of population
Weight gain

Indications / Usage areas

Use of IgG in a broader set of indications
Regular treatment of patients with chronic conditions

Per Capita Use 2014e

Region	IVIG (kg per million)	pd + re FVIII (IU per capita)
North America	177,9	7,8
Europe	45,9	4,0
RoW	8,7	0,6
Global	27,0	1,9

Source: Biotest Market Research (Basis: CIA Factbook, MRB 2013). Country selection according to MRB market definition: 36 European countries, 44 RoW countries.

IVIG Price Trends (Jan. 2012 – June 2014)

Trend Curves of IVIG Prices: Biotest (EU) vs. US Industry Average

USA: Industry Average Biotest: EU Average

Source: Biotest AG, Centres for Medicare and Medicaid Services (CMS). The chart above shows the linear trend curves of the reported per gram prices. EU average includes Austria, Germany, Hungary, Italy, Spain, Switzerland, UK. A constant exchange rate (30 June 2014) was applied to US prices.

Global market for immunoglobulins continues to grow

0 50 100 150 200 2014 2020 Further additional demand of IVIG up to 2020: 65 tonnes Capacity increase at Biotest up to 2018: 7.5 tonnes i.e. 11% of total additional demand 135 200

Global market volume for IVIG (tonnes)

Global plasmatic FVIII Market Forecast Volume Perspective

The global market for plasmatic FVIII preparations is expected to grow with an average growth rate of 2% p.a. until 2020.
Volume growth will mainly take place in emerging markets, a decline is expected for the US.

Source: Biotest Market Research

Global Albumin Market Forecast

The global Albumin market is expected to grow to ~965 t by 2020.
This is equivalent to a global annual growth expectation of ~ 4% p.a. in the period between 2014 and 2020.

Sources: Biotest Market Research based on MRB (2013), IMS (2013)

Biotest Next Level: Investments in growth

Increase in global capacity (p.a.) to:

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

Timeline

"Biotest Next Level": First projects initiated or already completed

"Biotest Next Level": Biotest's plan to more than double the production capacity until 2020

Already completed:

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

Construction advanced:

Plasma goods receipt area
Virological test laboratory

"Biotest Next Level": Production expansion advancing

Basic engineering completed in Summer 2014
Building application granted on 12 November 2014
Due to high energy efficacy Biotest was able to secure a € 85 m loan of the KfW* banking group with a ten years term and very favourable conditions

Biotest situation in the US

BPC headquarters in Florida

Experienced management in marketing & sales in the US
Additional distribution channels established
Number of plasma collection centres in the US increased to 18 by the end of 2014
Opening of three new plasma collection centres in 2015
Plasma sales to third parties increased including high margin hyperimmune plasma sales

Innovation Quality Responsibility

Research & development

Biotest products and pipeline

New products at the horizon

Tregalizumab (BT-061)

Tregalizumab targets a broad spectrum of autoimmune diseases
Rheumatoid arthritis (RA) is one of the lead indications
Psoriasis has been developed in first phase II studies
Currently on hold upon AbbVie request until after opt-in
Very good tolerability/safety is a competitive advantage for diseases that require life-long treatment

Current status

Production of clinical material for phase III started in 2014 at BPC with improved process
Yield approximately doubled
Phase IIb in RA ongoing

Tregalizumab (BT-061) Treat 2b study: Patient recruitment completed

Treat 2b: phase IIb trial in RA started in autumn 2013
Largest clinical trial in Biotest history:
300 patients
86 study centres in 14 countries, including USA, Canada and Europe
Recruitment completed in September 2014 (321 patients randomized)
Treatment of last patients will be completed end of February 2015
Top line data (24 weeks treatment) expected in Q2 2015

Q3 2015: AbbVie decision point on opt-in and start of Phase III

T cell REgulating Arthritis Trial 2b (TREAT 2b)

Civacir® investigational drug product

Intravenous Hepatitis C Immunoglobulin (10% concentration)
For the prevention of HCV* recurrence in patients undergoing liver transplantation (due to transplantation of HCV damaged liver)
Utilizes a short duration of new antivirals to reduce viral load just prior to transplantation
Civacir® antibodies neutralise any remaining HCV and protect the transplanted liver

Composition of Civacir®

• HCV mutates faster than HIV and an individual can be infected by several HCV mutant populations

Antibodies can be made against all HCV proteins; structural and non-structural
Antibody diversity is limited by genetics in any one infected individual, leaving gaps in patient's ability to neutralize HCV

structural			non-structural
					E2 NS2 NS3 4a NS4b NS5a NS5b 2
5'UTR IRES	p7					3'UTR
	core	envelope protease proteins	serine protease,	membranous web	RNA-dependent RNA polymerase
				helicase	cofactor for NS3

Civacir® has antibody diversity isolated from hundreds of HCV donors with high titres of neutralising antibodies

Civacir® therefore provides a spectrum of antibody protection to neutralise HCV and protect the new liver from infection

Chronic HCV patient´s situation today

Status quo: 150 million patients worldwide with chronic HCV infection (liver damage); many patients undiagnosed
risk that transplanted liver is re-infected after transplantation

Even with pre-treatment with Sofosbuvir or other new virostatics viral recurrence rate in transplanted patients is still ~40 %

*SVR = sustained viral response; source: Curry et al, AASLD 2013

Ongoing US Civacir® trial (study 988)

Evaluation of efficacy, safety & pharmacokinetics of Civacir® in liver transplant recipients
24 centres in North America
Leading hepatologists involved in study
Enrolling patients infected with HCV genotypes 1 6
Study will enrol up to 84 patients

Goal and positioning for Civacir®

Civacir® is a save and effective treatment option for patients with undetectable to <100 IU / ml viral load at transplantation
Transplantation is feasible as soon as antiviral reduces the viral load to <100 IU / ml:
High flexibility in time point of transplantation
No lengthy pre-treatment with antivirals required

Goal: the Hepatitis C virus is eradicated, the transplanted liver is protected and the patient is cured

988 Study: Interim Analysis (AASLD 2014 N. Terrault et al.)

Primary Objective

Determine proportion of Civacir® treated subjects with unquantifiable HCV RNA(<43IU/ml) at 22 weeks post liver transplant (LT) compared to the control group

Next update: EASL in April (planned)

SVR = sustained viral response

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
Sales potential in multiple myeloma of € 950 m; in triple negative breast cancer and bladder cancer € 1,100 m
Very convincing data from this phase II study (combination with Lenalidomide) have been presented at the ASH* conference on 6-9 December 2014
Study amended to include new treatment regimen (Pomalidomide/ Dexamethason)

ASH Poster: Indatuximab Ravtansine (BT-062)

BT-062 is well tolerated with LenDEX (Lenalidomide/Dexamethason)
Very good responses in patients with relapsed and / or refractory multiple myeloma and patients who do not respond to standard therapy
Overall response rate (ORR) for MTD is 83% including:
6% complete remissions
37% very good partial remissions
40% partial remissions
The data was presented at the 56. ASH conference on 6-9 December 2014 in San Francisco, USA (Kevin R. Kelly, et al.)

ASH = American Society of Haematology MTD = Maximum tolerated dose

Intensive Care Medicine: IgM concentrate and fibrinogen

IgM concentrate

IgM concentrate for the treatment of sepsis
Unique mechanism of action
Over 150 patients treated to date in phase II study

Fibrinogen

Fibrinogen for the treatment of severe acute bleeding due to fibrinogen deficiency
Phase I/II study ongoing

Vision – our road to 2020

Consistent focus on biological drugs for the therapeutic areas of haematology, immunology and intensive care medicine
Continuous investment in the development of new therapeutic options
Worldwide operations with a strong base in Europe and the US
2020 sales > € 1bn

Contact and Financial Calendar 2015

Investor Relations Biotest AG:	Financial Calendar 2015
Dr. Monika Buttkereit Head of Investor Relations
Phone: +49 (0) 6103 - 801 -4406 Fax: +49 (0) 6103 - 801 -347 E-Mail: [email protected]	24 Mar 2015 07 May 2015 11 Aug 2015 10 Nov 2015	FY Report 2014 3M Report 2015 6M Report 2015 9M Report 2015