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Biotest AG Investor Presentation 2016

Nov 10, 2016

66_rns_2016-11-10_fdadd0f1-7e74-4e7c-8061-a7969c5b6016.pdf

Investor Presentation

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Biotest AG.

Analyst Conference Q1-Q3 2016 Frankfurt November 10Frankfurt, 10, 2016

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: Q1-Q3 2016 at a glance

  • • Sales in Q1-Q3 2016 up by 9.0% to €455.6 m vs. €417.9 m in previous year period; Increase largely attributable to an increase in volume
  • • Q1-Q3 2016 EBIT increased to €26.1 m vs. -€82.0 m in the p y revious yea r
  • • Extraordinary tax and interest payment of €14.5 m for final settlement for Biotest AG with respect to business in Russia
  • • Opening of five plasma collection centres in the US (3) and Hungary (2) in (2) to date
  • •"Biotest Next Level" project is on track
  • •Guidance confirmed

Worldwide sales increases

Salesby region (€ million)

  • • Markets of North/ South America and Middle East & Africa and other Asia & Pacific made most significant contribution to growth
  • • Highest growth rates in the US with +43.5%
  • • Decrease in Germany due to one time effect of high plasma sales in previous year period p yp

EBIT and EBITDA (€ million)

Company Presentation Biotest AG 6

Reported EBIT significantly influenced by mAb and Biotest Next Level (BNL) (€ million)

mAb = monoclonal Antibodies

Financial position: strong equity base

Fi i l iti f th Bi t t G (€ illi ) Financial position of the Biotest Group million)

Positive cash flow from operating activities

January – September 2016 (in € million)

Cash flow from operating activities

January – September 2016 (in € million)

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Q1-Q3 2015 Q1-Q3 2016

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Positive development of key figures Sales, operating Cash Flow, EBITDA, EBIT

Company Presentation Biotest AG 13

Update BPC

  • • Kedrion Distribution & Commercialisation Agreement with BPC has a positive impact on business on
  • • Bivigam® batches on risk:
  • −Reduction of risk by € 3 5 million to 3.5 € 6 5 million 6.5
  • − In Q3 2016 some of the batches in question were inspected and approved within internal quality systems
  • •Opening of three plasma collection centres in the US

Research & Development projects

Biotest product and R&D portfolio

First Patient treated in global pivotal trial with IgG Next Generation (IVIG)

IgM Concentrate – preparation of phase III in sCAP

Fibrinogen

Fibrinogen:

Fibrinogen is a plasma-derived clotting factor for the treatment of acute haemorrhages due to congq g enital or acquired fibrinogen deficiencies

Congenital Fibrinogen Deficiency

•Phase I/III study: phase III part approved and ongoing

Acquired Fibrinogen Deficiency

  • •Paul Ehrlich Institute (PEI) supports Biotest concept of phase III study
  • •Phase III in acquired fibrinogen deficiency planned to start in 2017

BT-062 Indatuximab RavtansineOverview

  • • 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; poster presentati f on o study at ASH* conference
  • • Solid tumours: breast and bladder cancer; phase I completed, phase IIa study ongoing

* ASH = American Society for Haematology, Dec 3-6 , 2016 in San Diego, USA; abstract online since Nov 3, 2016

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

  • • A t t l f 17 ti t ll d D t t ASH*total of 17 patients were enrolled; Data at
  • •3 patients were not evaluable for response (less than 2 complete treatment cycles)
  • •11/14 = 79% showed an objective response (≥ PR) to treatment
  • •7 patients without progressive disease for more than 12 months than 12

* ASH = American Society for Haematology, Dec 3-6 , 2016 in San Diego, USA; abstract online since Nov 3, 2016

Indatuximab Ravtansine (BT-062) Solid Tumor Study no. 989 ongoing - current status

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Interim analysis supports continuation of phase IIa trial in SLE* with BT-063

Clinical proof of concept study phase IIa study no. 990

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

Duration: 3 months treatment + 4 months follow up

Study endpoints:

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

Status:

• The Data Safety Monitoring Board (DSMB) recommends the continuation of the study based on interim analysis from part I of the study.

*: SLE = Systemic Lupus Erythematosus ** SLEDAI: SLE Disease Activity Index

Biotest Next Level On track in terms of timeline and budget (October 2016)

Biotest Next Level - construction works on track

  • •Building shell is completed
  • • Interior fitting/ work (clean (clean-rooms laboratories cold rooms, laboratories, cold-rooms doorways etc ) are rooms, etc.) about to be completed
  • • Technical installations (power heating air Technical (power, heating, air-conditioning water/ waste water) as well conditioning, as media supply (e.g. compressed air, pristine steam/ vapor, heating/ cooling medium) is currently being commissioned. In parallel the qualification of operations is ongoing
  • •Installation of process equipment has started

Biotest Next Level Impressions from inside (1)

Biotest Next Level Impressions from inside (2)

Guidance 2016 confirmed

  • Sales: In the financial year 2016 sales will grow in a low single -digit percentage range
  • EBIT: EBIT in the range of € 33 -35million