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Biotest AG Investor Presentation 2017

Mar 30, 2017

66_rns_2017-03-30_5e42651e-24aa-49f6-b49b-5a27527d7047.pdf

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Biotest AG

Press and Analyst Conference FY 2016 Frankfurt am Main, 30 March 2017

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 figures reported relate to the Continuing Operations of the Biotest Group, if not specified otherwise. After the sale of the US Therapy business and contract manufacturing activities to ADMA Biologics Inc., these activities are being reported as Discontinued Operations. With the exception of the statement of financial position, 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: FY 2016 at a glance

  • • Biotest restructures US therapy business: Focus on plasma collection and its extension in the US
  • • Sales of Continuing Operations in FY 2016 up by 3.5% to € 553.1 m
  • • EBIT of Continuing Operations in FY 2016 up to € 63.9 m
  • • Ope g o s e p as a co ect o nin of six new plas m collection centres in the US (4) and Hungary (2) to date
  • • "Biotest Next Level Biotest Level"project is on track

Re-alignment of US business

Re-alignment of US operations to de-risk business and create optionality

Note: Restriction of voting rights to 25%-1 ADMA shares permits Biotest to deconsolidate earnings / cash flows of the US Therapy business without consolidating stake in ADMA.

Continuing vs. Discontinued Operations (€ million)

Sales & EAT – Discontinued Operations (€ million)

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Sales growth (Continuing Operations) (€ million)

  • •Strong plasma sales in the US
  • •Good development in Asia

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 2016 (€ million)

Guidance 2017

  • Sales: In 2017 sales will grow in a low single-digit percentage range
  • EBIT: We expect an EBIT in the range of € 46-48 million Profitability 2017 will be influenced by :
  • Biotest Next Level costs ~ € 60-70 million (incl. associated R&D costs)
  • R&D monoclonal antibodies ~ € 10 million
  • continued tense situation in crisis regions, especially in the Middle East

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

•Worldwide demand for IgG is growing

IVIG usage per capita 2015

Consumption

  • • Increased consumption in major markets
  • • Availability of raw material limits growth
  • R l bi•Regulatory barriers restrict global exchange
  • • Improved reimbursement outlook will support market growth

Source: Biotest Market Research based on PPTA (2016), MRB (2016), NBA Australia (2016), IMS Midas (2016), CIA World Factbook (2016). (1) Based on 2014 data.

Global FVIII market forecast

Volume perspective

  • •Stabilization of pFVIII following SIPPET study results
  • • Biotest will launch new recombinant Factor VIII (Vihuma) in the DACH region in order to capitalize on the company´s excellent long-lasting customer relationship

Key pillars of Biotest's strategy

  • • Drive organic growth with significant capacity and process investment
  • −Broadening of product portfolio
  • Doubling of production capacity
  • Improved yield
  • −Additional products f f rom every litre o f Plasma
  • • Capitalise on new product opportunities with strong in-house R&D capabilities
  • Focus on IgG Next Gen, IgM Concentrate, Fibrinogen
  • • Further leverage existing platform via value-enhancing partnering
  • Partnering strategy in selected R&D areas to leverage products beyond own production capacity
  • 50% 1 h ADMA hi 1 s hare ADMA ownership

Research & Development projects

Biotest product and R&D portfolio

  • •IgG Next Generation
  • IgM Concentrate
  • •Fibrinogen

IgG Next Generation (IVIG)

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

Clinical development

  • • Phase III study in PID* (EU + US): recruitment of adults nearly finalized – recruitment of children ongoing
  • •Phase III study in ITP** (EU): first patients treated in Q1 2017
  • •Phase III study in CIDP*** (USA + EU): study start planned for Q4 2017

*: Primary Immune Deficiency; **: Idiopathic Thrombocytopenic Purpura; ***: Chronic Inflammatory Demyelinating Polyneuropathy

IgG Next Generation (IVIG)

IgM Concentrate: Severe community acquired pneumonia (sCAP)

  • • Community acquired pneumonia (CAP) is a leading cause of illness and death worldwide(1)
  • • Severe CAP (sCAP) is usually defined as CAP that usually as that requires admission to the intensive care unit (ICU)
  • • sCAP is a progressive disease often leading to life-threatening sepsis and multiple organ failure

Chest radiograph

Hi h t di l d Hi g h unmet medical nee

  • • 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.

IgM Concentrate: CIGMA study (phase II) Key data

Stratification (baseline level)(1)

CRP = C-Reactive Protein.(1) 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

  • •V l d i b d CIGMA t d lt Value driver based on CIGMA study results
  • •Market size in sCAP approx. 350,000 patients worldwide(1)
  • •Sales p pp otential approx. €500 million p.a.
  • •High unmet medical need

Several upside indications possible

Current status

•

  • •Publication phase II results in preparation
  • •Phase III design in sCAP discussed with FDA and PEI

Fibrinogen: Development for congenital and acquired fibrinogen deficiencies

  • •Fibrinogen plays an essential role in blood clotting
  • •A sufficient plasma fibrinogen level is critical for effective haemostasis

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Phase I:completed

  • •Single dose of fibrinogen
  • • PK parameters and surrogate efficacy (MCF)

Phase III: ongoing

  • O d d h l i /t t t • Ondemand prop ylaxis / treatment•
  • Clinical efficacy / surrogate efficacy (MCF)

Phase III study acquired fibrinogen deficiency

  • • Caused by major surgery associated with excessive blood loss
  • Ö Clinical study start 2017

MCF = Maximum clot firmness.

RI-002

IVIG

  • • Novel IVIG, manufactured from a unique plasma pool formed by blending high-titer Respiratory Syncytial Virus (RSV) Virus
  • • Initial target indication Primary Immune Deficiency Disease (PIDD)

Clinical trial data results

lead product Respiratory Syncytial Virus (RSV)

  • • RSV Infection is a serious problem for Immune-Compromised patients

  • • Approximately 5-15% RSV infection rate in immune-compromised patient populations

  • • Pivotal Phase III trial achieved primary endpoint (rate of serious bacterial infection (SBI) per patient / year < 1 SBI)

  • • RI-002 prevented serious bacterial infections such as bacterial pneumonia, osteomyelitis and bacterial sepsis demonstrating no SBI in 55 patient / years

Label expansion

• Potential future follow-on target populations for RSV specific indications: HSCT / BMT, solid organ transplant, chemotherapy and other immune-compromised patients

Monoclonal antibodies – BT-062

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Monoclonal antibodies – BT-063

• Humanised monoclonal antibody, which selectively neutralises human interleukin-10, thus representing a new approach to treat autoimmune diseases (SLE*)

Clinical proof of concept study phase IIa study

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) recommended the continuation of the study based on interim analysis from part I of the study.
  • P t II t t d i F b 2017 it t i•Part II starte in e2017, recruitment ongoing

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

Biotest Next Level 2016

BNL enhancing utilization of plasma

T do

day BNL f ll d fully rampe d-up

…will be long-term driver of profitability

Biotest Next Level - construction works on track(March 2017)

Interior fitting/ work (cleanrooms laboratories cold rooms, laboratories, coldrooms, doorways, etc.) almost completed

•

• Technical installations (power, heating, airconditioning, water/ waste water) ll di ) as well as media supply (e.g. compressed air, ultra pure media, heating/ cooling medium) are in operation and qualifications are ongoing

Biotest Next Level Impressions from inside

Installation of process equipment is almost completed; first qualifications of process equipment have started

Summary

  • •Continuously expand the plasma collection network
  • • Biotest Next Level - construction works on track
  • ¾Broadening of product portfolio
  • ¾Doubling of production capacity
  • ¾Increase yield
  • ¾Additional products from every litre of plasma
  • • Clinical trials for new BNL Products ong g(g , g , g oing (IgG Next Gen, Fibrinogen, IgM in preparation)
  • •Additional life cycle projects ongoing

Financial Calendar 2017Contact Financial Calendar 201710 May 2017 3M Report 2017 14 AuInvestor Relations Public RelationsDr. Monika Buttkereit Dirk Neumüller6103 801 4406 Tel : +49 6103 801 269

g 2017 6M Re port 2017 g p 14 Nov 2017 9M Report 2017

Tel : +49Tel.:+49-6103-801-4406Tel.: [email protected] [email protected]

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