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Biotest AG Investor Presentation 2014

Mar 25, 2014

66_rns_2014-03-25_792b49cc-cd49-4bcd-a946-8e92aeba26c5.pdf

Investor Presentation

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Biotest Group

Press and Analyst Conference FY 2013 Frankfurt am Main, 25 March 2014

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 subsidiaries. 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 developments.
  • • The forward-looking statements are only valid at the time of publication. Biotest does not intend to pdate the for ard to update forward-looking statements and looking statements assumes no obligation to do so.
  • • All comparative figures relate to the corresponding last year´s period, unless stated otherwise.

Biotest Group: Highlights FY 2013

  • • FY 2013 group sales up by 13.8% to € 500.8m Increase attributable to significant higher sales in the US and in Asia Asia.
  • • FY 2013 EBIT increase by 20.4% to € 53.8m
  • •Successful capital increase
  • • Successful placement of privately placed promissory note (Schuldschein) of € 210m
  • • Start of "Biotest Next Level" – doublin g of production capacities at headquarter in Dreieich

Financials FY 2013

Biotest with a significant sales growth

Sales (in € m)

  • FY 2013 sales at € 500.8m, a growth of 13.8% vs. € 440.0m in FY 2012
  • Increase attributable to significant higher sales in the US and in Asia

Biotest with a strong EBIT growth

EBIT (in € m)

  • EBIT increase is largely due to higher is largely due sales in international markets
  • Shift of products in markets with higher margin

* Continuing Operations

FY 2013: EBIT Biotest Group (in € m)

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* Continuing Operations

Very strong increase in EBT and in EAT in 2013

EBT and EAT (in € m)

Company Presentation Biotest AG

Strong balance sheet after restructuring of financing

Balance sheet of Biotest Group (in € m)

Assets

  • • Current assets: Cash increase of € 147.2m
  • • Increase in inventories and receivables d t t thdue to strong growth

Equity and Liabilities

  • • Successful capital increase with gross proceeds as of € 76.1m
  • • Successful placement of privately placed promissory note (Schuldschein) of € 210m
  • Equity ratio as of 31 Dec 2013: 52.0% Dec 2012: 54.1%)

Cash flow from operating activities

January – December 2013 (in € m)

Development of dividend per share in €

Biotest stock: attractive development

Biotest AG share price performance vs. SDAX Coverage Target 170180190SDAXof Biotestprice [€] Commerzbank u.r.*150160Biotest preference shareBiotest ordinary Solventis u.r.*equinet 82.5 130140share HSBC 83.0Hauck & Aufhäuser109.0110120 Main First 146.0Sh h ld t ** 9010019 March 2013 24 March 2014• Shareolder return**:82% (ordinary shares) 66% (preference shares) Closing price on 19th of March 2013 = 100 * under review** Performance 03/2013 – 03/2014 plus

dividend for 2012 (as of 08 May 2013)

Biotest stock: attractive target for large investment funds

Monthly preference share turnover [Xetra in € m]

  • I d li idit d t it l i • Increasedliquidity due to capital increase
  • • International investors (Allianz Global Investors, Flossbach von Storch, JO Hambro, BNP, Jupiter, Fidelity, Candriam Belgium, Fisher Funds, Danske Bank, UBS)
  • •Biotest has become an interesting target for larger, international funds

Guidance 2014

  • Sales:In the financial year 2014 sales will grow in a range of 10%
  • EBIT:We expect an EBIT increase of approximately 10%

Extension of international business

Immunoglobulin (IgG) market development

•The global IgG market is expected to grow to ~180 tons by 2018.

Sources: Biotest Market Research based on MRB (2013)

Global Immunoglobulin market: geographic split

  • •The global IgG market is expected to grow to ~180 tons by 2018.
  • •The market share of RoW countries is expected to increase to 31%.

Sources: Biotest Market Research based on MRB (2013), Morgan Stanley Research (October 29, 2013), UBS Investment Research (March 29, 2013)

Growth rates of Immunoglobulin markets

• With an annual growth rate of 11% between 2008 and 2012, Biotest grew faster than the IgG world market.

* 2013 includes actual Biotest sales. All other markets were forecasted based on the 2012 figures. Sources: Biotest Market Research based on MRB (2013), Morgan Stanley Research (October 29, 2013), UBS Investment Research (March 29, 2013).

No oversupply in Immunoglobulins expected

BPC: Bivigam® in the US

BPC (Biotest Pharmaceuticals Corp.):

  • • BPC has received marketing authorization of Bivigam® end of 2012
  • •Successful launch of Bivigam® in the US in February 2013
  • Bi i ® •Bivigam i ll t d i th k t is well accepted in the market
  • • Recall of two batches of Bivigam® in the US in February 2014 due to quality issues with a few glass vials
  • •Cost of recall for testing and re-labeling is included in 2013 result
  • •This has resulted in delay of delivery to distributors and customers in 1st quarter 2014
  • •Sales estimate for Bivigam® in US for 2014: approx. \$ 60m

Sales potential Bivigam® from 2015 onwards of \$ 100m

China: moving into a growth market

  • • China is world's third-largest pharmaceutical market
  • •Double-digit growth rates
  • • Albumin market in China (2012): 205 t Import into China 50% average selling price: \$ 4.6/g
  • • Distribution partnership with leading Chinese pharmaceutical company Wanbang (belongs to Fosun Pharma Group)
  • • Regulatory approval for Albiomin 20% expected in Q3 2014
  • •First sales of Albiomin expected end of 2014

Brazil: approval of Biotest products

  • • Approval of Albiomin 20% in Brazil in November 2013
  • • Further Biotest products under regulatory evaluation (Zutectra ®,Fovepta ®, Intratect ®and Pentaglobin ®)
  • • Brazil is the largest market in South America for plasma proteins and has a st th t ti l trong growth potenti al

France: new subsidiary established

  • •New subsidiary founded in France
  • •First sales in France
  • • Approval of Zutectra ®
  • • Transfer of regulatory approval from former distributor for Tectasim (similar to Intratect) soon

Important projects

Three strategic areas of therapy: Products - Pipeline

Civacir® – Immunoglobulin with high potential

  • • Hepatitis C immunoglobulin for reinfection prophylaxis after reinfection liver transplantation
  • • "Orphan drug designation" in Europe and US: 10- and 7-y y ( p y) ear exclusivity after authorisation (respectively)
  • • Very high medical demand:
  • Currently no reliable prophylaxis for the critical period i di t l ftimmediately after t l t ti i il bl transplantation is available
  • prevention of re-infection within first two month; in this time frame no virostatics can be used due to toxicity in combination with immunosuppressive therapy
  • In the EU and US alone, more than 5,000 liver transplants due to hepatitis C each year >>this corresponds to a market potential > to >€ 200 m
  • • Clinical trial phase III in USA ongoing: inclusion of up to 91 patients planned in phase III trial in US; first patients successfully completed the study protocol
  • Scientific advice meetings with European Regulatory Authorities planned for Q2 2014

IgM Concentrate: development on target

  • • IgM Concentrate for effective treatment of sepsis (severe bacterial infection)
  • •Unique mechanism of action
  • • Interim analysis of ongoing phase II trial: continuation of develop y ment clearl recommended*
  • • Currently more than 100 patients have been included
  • • Study sites:
  • Germany: 16 active
  • S i 12 ti Spain: 12 active
  • UK: planned 6
  • Belgium: 1 active

Fibrinogen – start of clinical development

  • •Severe bleeding is often associated with Fibrinogen deficiency
  • •Goal will be to enter the market with a "ready to use" formulation
  • • Phase I/II Study in patients with congenital Fibrinogen deficiency started Q1 2013
  • • Fi t rs pati t en s t td rea edi Ph I/II in Phase I/II st dudy
  • •Sales potential: about € 100m/year

Tregalizumab (BT-061)

  • •Lead indications: Rheumatoid Arthritis (RA) and Psoriasis
  • • 6 months treatment with open label extension, prospective, placebocontrolled trial

R lt i f td Regulatory issues of stu dy

  • Full approval in 13 countries (incl. US and Canada)
  • •more than 70 sites initiated and activated
  • •More than 300 patients have been screened so far
  • • More than 25% of total p () atient number (n=304) have been included in the study

Indatuximab Ravtansine (BT-062) in Multiple Myeloma

Linesof treatment

Indatuximab Ravtansine(BT-062)

Combination study 983: BT062 + Lenalidomide + Dexamethasone

Multiple Myeloma

  • •Phase I /II ongoing
  • •BT-062 well tolerated in this combination regimen
  • • P ti t h il t t d b t 90% f ti t h d i atients were heavily pretreate d; a bout 90% of patients ad prior Lenalidomide exposure
  • • 100% of patients showed a clinical improvement; in more than 75% of clinical in than evaluated patients complete, very good partial response or partial response have been observed
  • • R hi d i i f i Responses were even achieve in patients refractory to prior L lid id Lenalidomid eand Dexamethasone therapy

Indatuximab Ravtansine (BT-062): solid tumor study 989 Main study criteria

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BT-062 – market potential worldwide markets

BT-062 is developed in indications with high unmet medical need.

Eligible Patients* Market potential Multiple Myeloma (relapsed and refractory) (Peak Net Sales) Triple Negative Breast Cancer (metastatic setting 2nd/1st line) ~80,000 ~ € 950m setting, 2 /1 ~50,000 ~ € 300m Invasive Bladder Cancer (metastatic setting, 2nd/1st line)

Initial labels for BT-062

Over a period of the next 10 years, high costs for clinical development and market introduction

ÆCollaboration with strategic partner essential for raising full potential of BT-062

* Number of patients who become eligible for drug treatment at particular stage - source: Decision Resources 2013 for 7major markets and Biotest estimates

~90,000 ~ € 750m

New products at the horizon

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New Biotest investments in Dreieich until 2018

Biotest investments in further growth

Expansion of global capacity to:

Plasma fractionation:

3 million litres/year currently: 1.5 m litres/year

Immunoglobulins:

13 t/year currently: 5.5 t/year

  • • Capacity expansion programme in Dreieich
  • • Construction of new production plants at head quarter in Dreieich
  • •Duration: 2013 to 2018
  • •Investment: € 200 - 250m
  • • More than 300 additional jobs

First layout impression: production building

Current activities: parking structure

Park deck will be finalised in April 2014 to ensure availability of property of propertyneeded for production area.

Timeline

Contact and Financial Calendar 2014

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