Biotest AG

Press and Analyst Conference FY 2015 Frankfurt am Main 23 March 2016Main,

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 p , lans 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 comparative figures relate to the corresponding last year´s period, unless stated otherwise.

Biotest Group FY 2015

• Sales FY 2015: € 589.6 million, +1.3% EBIT FY 2015: € -71.8 million
•Impairment of US business in Q3 2015 2015
•Q4 2015 EBIT: € 10.2 million (above guidance)
•Re-focusing of core business
• Depriorisation of monoclonal antibodies after not meeting the primary endpoint in BT-061 study
• Bi t t N t L l i t k ith t t ti li d b d t otest Next Level is on track with respect to timeline an udget
• Positive results :
IgM Concentrate shows encouraging results in life life-threatening pneumonia threatening
Pentaglobin ® – very good results in treatment of donor specific antibodies after lung transplantation
Zutectra®: marketing approval for early use in EU

Biotest Next Level Objectives

•Broadening of product portfolio
•Facility expansion
•Increased profitability

Biotest Next Level

•Product portfolio expansion:
3products out of one litre plasma 5 products out of one litre plasma
•Capacity expansion: 5.5t 13t immunoglobulins
¾Increase of profitability

~400 €/l

Biotest Next LevelDreieich-Site 2012 => 2020

Biotest Next LevelLab building and plasma receiving building

Lab building

•Virology
•Virus validation
•Sorting area
• -30°C storage capacity g py

Biotest Next LevelAs per April 2015

Biotest Next LevelOn track in terms of timeline and budget (March 2016)

Biotest Next LevelProduction building - product flow

Raw material – Plasma, F VIII eluate for Fibrinogen

I t di t Intermediates – Alb i Fib i I G/I MAlbumin, Fibrinogen, IgG/IgM, Cryo paste

Sales development

Influence of cooperation agreement on sales and EBIT (€ million)

Sales growth

•Solid growth in Germany
• Strong plasma sales in the US in US•
Good development in Asia

Statement of income Profit & Loss positions in % of sales

EBIT and adjusted EBIT

	2 0 1 4	2 0 1 5
( € ) E B I T i l l i m o n	5 3 4	7 1. 8 -
f f * I i t d t i t m p a r m e n a n o n e m e e e c s	-	2 7 7
** B i t t N t L l t o e s e x e v e c o s s	1 5 4	2 3 3
M l l i b d i t o n o c o n a a n o e s	3 8 2	0 1 5
( & ) I d l i t t B D i i h e c a p a c y c o s s o c a r e e c	1 6 2	1 2 4
E B I T d j t d a s e u	1 2 3 2	9 1. 2

* € 2.8 million are recognised in monoclonal antibodies

** R&D costs related to the BNL project only are included in BNL costs

Balance sheet

Fi i lnancial position of th Bi t t G f the Biotest Group (€ milli ) on

Cash flow from operating activities January – December 2015 (in € million)

Sales: In the financial year 2016 sales will grow in a low single-digit percentage range
EBIT: We expect an EBIT in the range of € 30 million Profitability 2016 will be influenced by :
Additional requirements in quality and safety ~ € 3-5 million
Biotest Next Level costs ~ € 10-15 million
R&D monoclonal antibodies ~ € 12 million
Unabsorbed costs for idle capacity ~ € 8-10 million

Strategic targets of Biotest

¾Re-Focus on plasma business

¾Strengthen US profitability

¾ Expansion project Biotest Next Level
Broadening of product portfolio of
Doubling of production capacity

¾Adjustment of R&D programme

¾ - Focus on IgG Next Gen, IgM Concentrate, Fibrinogen
Monoclonal antibodies: minimize expenses, continue activities solely up to next milestone to enable partnering
¾Continue of "partnering-strategy" in selected areas

¾ Increase of p y rofitabilit

Global IgG (i.v. + s.c.) market forecast

•The global IgG market is expected to grow to ~270 tons by 2023.
•Expected annual growth is highest in ROW countries.

Global FVIII market forecastVolume perspective

•The global FVIII volume is expected to grow by 4% p.a. in the period up to 2020.
• The plasmatic segment will grow by 2% p.a. in volume until 2020. In the recombinant segment, growth will predominantly come from the new long predominantly long-acting preparations. acting

Source: Biotest Market Research

Note: SA = short-acting, LA = long-acting

Strengthen US profitability

Biotest Pharmaceuticals Corporation (BPC) and Kedrion Biopharma Inc., New Jersey signed a cooperation contract on marketing & sales of Bi i®vigam

• Kedrion will take over exclusively the marketing & selling of Bivigam ®in the US

¾The manufacturing capacity utilization will be significantly increased

¾ I f fit bilit i 2016 b USD 4 Increase o f profit ability, in by 4-5 illi mon

Development of Product Portfolio and R&D Programme

Biotest product and R&D portfolio

IgG Next Generation

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

Clinical development

• Phase III clinical development (EU/US) planned to start in H2 2016 in two indications
• An additional phase III study in a neurological indication is currently under evaluation - finalization of study design is planned for Q3 2016

IgM Concentrate Severe Community Acquired Pneumonia (sCAP)

Community acquired pneumonia (CAP) is a leading cause of illness and death worldwide1
CAP is an infection of the lungs occurring in people who have not been recently hospitalized
Severe CAP (sCAP) is usually defined as CAP that () y requires admission to the intensive care unit (ICU)
sCAP is a progressive disease often leading to lifethreatening sepsis and multiple organ failure organ

High unmet medical need

M t lit f CAP ti t d itt d t ICU ll f 23 Mortality of sCAP patients admitted to ICUs usually ranges from 23-58% depending on time and admission to hospital 2,3
Mortality rates have not changed significantly over the past several decades despite the availability of improved broad-spectrum antibiotics

1: Wunderink 2014, N Engl J Med 370;6, 2: Woodhead , 2006, Critical Care 10:S1, p3, 3: Sirvent et al. 2013, Med. Intensiva 37:308e 15

Chest radiograph3

IgM Concentrate CIGMA study – objectives & endpoints

Objectives

Evaluation of the efficacy and safety of IgM Concentrate in patients with sCAP

Primary Endpoint / Key Secondary Endpoints

Increase of ventilator free days (VFD)s
28-d ll t lit day all cause mortality

Key inclusion criteria

Pneumonia has been acquired outside the hospital or diagnosed within 72 hours after hospital admission
Patient receiving adequate antibiotic treatment for pneumonia
Major sCAP criterion: need for invasive mechanical ventilation

Markers for post hoc analyses were selected based on scientific/medical considerations

IgM Concentrate CIGMA study design

• A randomized, double-blind, placebo-controlled, multicenter, parallel group, adaptive group-sequential phase II study
•160 patients randomized in Germany, Spain and UK Germany,
•5 daily infusions of IgM Concentrate (42 mg IgM /kg body weight) or placebo
•Start of IgM Concentrate or placebo within 1-12 h after start of ventilation

IgM Concentrate CIGMA – summary incl. post hoc analyses

CRP = C-Reactive Protein

* Descriptive p-values from a Fisher's Exact Test with a significance level of 0.05 have been calculated for subgroups.

IgM Concentrate

Attractive market potential

• S C it A i d P i Severe Community Acquired Pneumonia
−Value driver based on CIGMA study results
Market size in sCAP approx. 350,000 patients worldwide*
Sales potential approx. € 500 million p.a.

P t ti l id i di tiPotential upside indication ( ) early to market indication)

• Common Variable Immunodeficiency Disease (CVID)
e.g. I Mg d fi i ^e ^c ency

Pentaglobin® Encouraging results in lung transplantation

• In lung transplantation donor specific antibodies (DSAs) are risk factors for mortality, and t d h i ft j ti d acute and chronic graft rejection
• Patients treated with Pentaglobin (a IgM/ IgA enriched immunoglobulin ) with early DSAs de elopment after l ng transplantation had ^a significantl development lung significantly higher ^s ^r i al survival rate than patients treated with therapeutic plasma exchange (standard therapy)
• Published data by the Hannover Medical School School*
¾> 70% reduction of relative mortality rate after one year
> Mortality risk caused by DSA after lung transplantation was significantly reduced with Pentaglobin® (First generation IgM/ IgA enriched immunoglobulin)

Fibrinogen

• Fibrinogen plays an essential role in blood clotting
• A sufficient plasma fibrinogen level is critical for effective haemostasis
• In the case of congenital fibrinogen deficiency case patients can not produce sufficient or any fibrinogen
• In acquired fibrinogen deficiency patients lose deficiency, fibrinogen because of heavy bleeding, for example due to severe injuries and surgery
• In both cases fibrinogen is needed cases, to stop bleeding

Fibrinogen Development for congenital and acquired fibrinogen deficiencies

Phase I/III Study Congenital fibrinogen deficiency

9Phase I: completed Single dose of fibrinogen of PK parameters and surrogate efficacy (MCF) caused by major surgery associated with excessive blood

Phase III: ongoing On-demand prophylaxis/treatment Clinical efficacy/surrogate efficacy (MCF)

Phase III Study Acquired fibrinogen deficiency

loss

Öplanning phase

MCF = Maximumclot firmness

Next generation Haemophilia A therapeutic

• D l t f bi t F t VIII l l l t d t th Development o f a recombinant Factor VIII closely relate to the wild type Factor VIII with improved characteristics such as half life extension and lowered immunogenicity
•Preventing inhibitor development
•Extension of treatment intervals

BT-062 Indatuximab Ravtansine Overview

• Antibody Drug Conjugate (ADC), an innovative therapy approach for the treatment of multiple myeloma
• Combination of antibody and cytotoxic agent targets cancer cells
•Combination of efficacy and tolerability
• Multiple myeloma: all patients recruited, treatment ongoing; report on studd i l y data incl. PK* modeling expected in Q4 2016
• Solid tumours: breast and bladder cancer; phase I completed, recruitment in extension phase ongoing

BT-062 phase I/IIa study no. 983 in Multiple Myeloma Results of BT-062 with Pomalidomide / Dexamethasone

•A total of 17 patients were enrolled; 2 patients were replaced (not evaluable for efficacy)
• 11/15 = 73% showed a response ( ^≥ PR) to treatment
• 8 ti t t t t 8 patients are on treatmentwith t i di f th 8 th ithout progressive disease for more than 8 months

* Pomalidomide / Dexamethasone

BT-063 in Systemic Lupus Erythematosus (SLE)

**Clinical proof of concept study phase IIa study no 990* no.**

Patients with moderate to severe SLE on stable medication with joint and cutaneous manifestations

Duration: 3 months treatment ⁺ 4 months follow up

St d d i t udy en dpoin ts:

•Primary: Incidence of adverse events, changes of safety parameter
•Secondary: Improvement of joints, improvement of skin, SLEDAI**

Status:

•Last patient recruited in part I of the study
R lt f i t i l i f t I f th t d t d f Q3 2016 •Results o interim analysis from part I o the study expecte for

* ClinicalTrials.gov Identifier-No.: NCT02554019; ** SLEDAI: SLE Disease Activity Index

BT-063Role of Interleukin-10 (IL-10) in Immuno-Oncology

Background

• IL-10 levels are often elevated in serum and tumor microenvironment of cancer ti t¹ patients1
•Increased IL-10 serum levels correlate with poor survival2
• Elevated IL IL-10 serum levels are expected to inhibit the effects of new 10 to of immunotherapies like checkpoint inhibitors (PD-1, PD-L1), TLR agonists, cancer vaccines

Combining immune immune-stimulatory treatments with anti stimulatory anti-IL-10 therapy (BT 10 (BT-063) has the 063) potential to strongly increase the therapeutic success in cancer patients

•Sound scientific rationale
•Evidence from preclinical models preclinical
•High interest in anti-IL-10 treatment by academia and industry

Increase of EBIT guidance

Outlook 2016

•Increase of EBIT guidance >10% due to good start in 2016
• Low singg g p le di git sales growth ex pected in 2016
•Profitable business with attractive R&D pipeline

EBIT guidance 2016 in a range of € 33-35 million

Contact Financial Calendar 2016 Financial Calendar 2016Investor Relations

Dr. Monika ButtkereitHead of Investor Relations

Phone: +49-6103-801-4406Report E-Mail: [email protected]

12 May 2016 Annual Shareholder Meeting

11 Aug 2016 6M Report 2016 10 N 2016 9M R t 2016 Nov

12 May 2016 3M Report 2016

Company Presentation Biotest AG 44