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Biotest AG Earnings Release 2011

Nov 10, 2011

66_rns_2011-11-10_fafc5021-582b-406f-bd2e-948241f650ca.pdf

Earnings Release

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Press and Analyst Conference – Q1 - Q3 2011 Frankfurt/Main, November 10 10, 2011

Disclaimer

  • • This document contains forward forward-looking statements on overall economic looking 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 the forward-looking statements and assumes no obligation to looking do so.
  • • All figures reported relate to the Continuing Operations of the Biotest Group. After the disposal of the transfusion and transplantation diagnostic activities to Bio Bio-Rad Laboratories Inc., these diagnostic activities are being reported as Discontinued Operation. Due to the companies intention to sell the segment of Microbiological Monitoring, these activities are also reported under "Discontinued Operation". With th ti f th t t t f fi i l iti th i the exception of the statement of financial position, the previous year´s fi h gures have been adjusted accordingly.
  • • All comparative figures relate to the corresponding last year´s period, unless stated otherwise.

Biotest Group: Highlights Q1- Q3 2011

  • • Biotest Q1- Q3 2011 Group Sales up by 1.9%; Increase largely attributable to an upfront payment by Abbott on a pro rata basis to the Biotherapeutics segment
  • • Q1- Q3 EBIT decreased by 1.6% due to difficult plasma protein market environment and unabsorbed costs in Boca Raton
  • • Biotest and Abbott signed a Licence, Development and Commercialization Agreement for BT-061 in June 2011
  • • Microbiolog gg p ical Monitorin g: Closin g of a sale and purchase Agreement with Merck KGaA Darmstadt, Germany on 1st of Aug. 2011. Profit after Tax of € 22 million
  • • Bivi gamTM g : Remainin g g outstandin g data submitted to FDA with additional conformance lots data

Financials Q1- Q3 2011

Biotest Group: Continuing and Discontinued Operations

Earnings after tax

EAT FY
2009		 FY
2010		 $Q1-Q3$
2011
Continuing 29.6 19.6 14.6
Discontinued $-1.6$ 19.9 25.9
Total 28.0 39.5 40.5

Significant increase in EAT

EAT (in € m)

  • Earnings after tax (Continuing and Discontinued Operations) up by 31.1%
  • • Earnings after tax (Continuing Operations) + 43.1% increased by 14.1%
  • • Tax rate 27.7% in Q1- Q3 2011 vs. * 33.7% in Q1- Q3 2010

*Discontinued Operations

Decrease in EBIT – increase in EBT in Q1-Q3 2011

EBIT and EBT (in € m)

Financial result:

  • • Financial result Q1- Q3 2011 at Q1 -9.9 € million vs -11.3 € million in 2010
  • • Initial devaluation of Greek receivables/ bonds in the previous 30.6 year
  • • Various devaluations of Greekzero bonds in current year
  • • Today the Greek bonds are valued at 50.5% of the nominal value

Q1-Q3 2011: EBIT Biotest Group (in € m)

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Revenue growth in difficult market environment

Revenue (in € m)

  • Q1- Q3 2011 Sales at € 311.9 million, a growth 1.9%of 1.9% vs € 306.0 million in Q1 - Q3 2010
  • • Increase largely attributable to an upfront payment by Abbott on a pro rata basis to the Biotherapeutics segment
  • • Sales in the Plasma Protein segment decreased by 2.4 % due to difficult market environment
  • • Prices under pressure, particularly in markets outside the EU and the USthe

Strong balance sheet

Balance sheet of Biotest Group Assets

(in € m)

  • • Strong increase in cash and cash equivalents due to Abbott agreement and the sale of the microbiology monitoring t
  • The interest-free Greek bonds have a nominal value of € 18.8 million (30 Sep a amount of € 9.5 million (50.5% of the nominal value)

Liabilities

  • • Significant reduction of net debt to € 41.3 million (vs. € 142.6 million on 31 Dec 2010)
  • • Equity ratio as of 30 Sep 2011: 47.1% (31 Dec. 2010: 48.6%)

Cash Flow from Operating Activities in € m* January – September 2011

Guidance 2011

  • Sales: Sales to grow with a low single digit percentage compared to 2010
  • EBIT:EUR 40 million range

The guidance does not take into consideration any extraordinary income from Discontinued Operations. !

Important strategic milestones

Big Success for Biotest's Biotherapeutics:

Biotest and Abbott signed a

"License, Development and Commercialization License, Agreement"

to ensure the further development as well as later on production and worldwide marketing and sales of BT-061

Biotest Analyst Conference November 10, 2011 14

Biotest and Abbott global agreement for BT-061

  • • Upfront payment of USD 85 million; Total Potential Milestone Payments USD 395 million; million; Total Deal Value: USD 480 million
  • • Biotest will be eligible to milestone payments pending completion of certain d l t l t i l d l il t development, regulatory, commercial an d sales milestones
  • •Joint development by Biotest and Abbott
  • •Abbott and Biotest will share responsibility for commercial production
  • •Biotest to co-promote BT-061 in Germany, France, United Kingdom, Italy, Spain

Partnership update

• The joint development has started immediately, implementing respectiv development comitees

Financials

  • •Sales contribution Biotherapeutics from upfront payment: € 13.2 million
  • • EBIT ib i EBIT contribution: approx. €12 illi 12 million

Biotest sold Microbiological Monitoring business to Merck KGaA

  • • On 1st August, 2011 the agreement to sell the activities of the Microbiological Monitoring segment to Merck KGaA (Darmstadt/ Germany) went into effect (closing)
  • •Transfer of activities to Merck KGaA completed
  • • P fi f (Di i d O i ) Profit a fter tax (Discontinue Operations) € 22 million

Plasma Proteins

The price of IVIG in the US still stable on a high level

IVIG Price (USD/gram)

  • •The US is the biggest single immunoglobulin market in the world
  • • Regardless of the pricing developments in EU and RoW, the price in the US remains stable on a high le el on vel

Source: Average Selling Price based on CMS Medicare pricing; IVIG market – MRB and company data

In markets outside of the US, the price of IVIG remains under pressure

• In German hospitals, the price of polyvalent immunoglobulins remains on a low level ith l ff i ifi tl b lwith several offers significantly elow average

Source: IMS DKM

The majority of Biotest's products are currently sold in middle and low price countries

Source: Company data (Q1-3 2011)

IVIG Biotest

• Strong constant growth in volumes with lower growth rates in terms of sales -> result of decreasing prices since 2010

New markets/new products

BivigamTM (IVIG) FDA filing in US

Polyspecific

  • • Restart of production in August after solving severe problems with the immunoglobulin severe automation and control system
  • • Additional conformance lots wereproduced in Q3 2011
  • • Remaining outstanding data with additional conformance lots havebeensubmitted to FDA in Oct. 2011
  • •Expected launch Mid 2012
  • • G adua r l sca el up of p oduct o roduction in H2 2012

US Market entrance of strategic importance to Biotest

Major progress in development of Plasma Proteins (I)

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Cytotect 70®

Indication

• Prevention of congenital cytomegalovirus (CMV) infection of infants of mothers with primary CMV infection during pregnancy

Market Position

  • •High medical need
  • •Unique position in the pharmaceutical market
  • • Indicationwith high ethical visibility
  • •Orphan drug designation in EU and US granted

Status

  • •~ 9500 pregnant women screened today
  • •47 seroconverted (i.e. infected during pregnancy for the first time) women included
  • •Interim analysis planned for Dec 2011 planned

Competition

•Biotest only supplier of CMV hyperimmunoglobulins in the EU

IgM Concentrate

Rationale

  • •Data of Pentaglobin® in sepsis show reduction of mortality in sepsis
  • • IgM concentrate is expected to be superior to Pentaglobin® be Pentaglobin due to ® higher content of IgM and higher functional properties

Indication:

  • • Severe Community-Acquired Pneumonia (sCAP) = Pneumonia acquired from outsidethe hospital
  • • Ten percent of adult CAP patients require intensive medical care and are transferred to intensive care units. Mortality rate is 35-58%.

Status

•Phase II international, placebo controlled, double blind, randomized study started

Impact of Hepatitis C Infection on the Demand for Liver Transplantation

Estimation:

  • • ∼ 3% (130-170 million people) of the world's popul ti a on s how ch i ronc h titi epatiti s C (HCV) i f ti n fection
  • •3 – 4 million people are infected each year
  • • 5 - 20% will develop liver cirrhosis*, thereof ∼ 5%develop liver failure or liver cancer**
  • • HCV is the highest risk factor for liver transplantation (∼ 40% of all patients receiving a liver transplant) = 4000 liver transplantations due to chronic HCV infection
  • • No treatment is so far available to protect the new liver from HCV reinfection from the first day on after transplantation

* WHO Fact Sheed No164** UNOS/Eurotransplant/local transplantation societies

Civacir

I di tiIndication:

  • • Prevention of hepatitis C re-infection of the transplanted liver
  • ÎProtection of the liver transplant from the beginning on with Civacir ® the Civacir®

Rational for development

  • •Protection of the transplant is ke is key
  • •First 6 month after transplantation are the critical time period for re-infection
  • •Standard antiviral therapy p p can not be used up to 6 months after transplantation
  • •No comparable product is on the market
  • •Orphan drug designation granted in EU & US

Status

•Phase I clinical trial planned to start in 2012

Biotherapeutics

Biotest's Biotherapeutics portfolio

Cooperation with Abbott successfully established

  • • Abbott and Biotest benefit from each others strenghts
  • Abbott from deep knowledge of BT-061 provided by Biotest
  • Biotest from experience and operational power of Abbott in the field of Rheumatoid Arthritis
  • •Joint Development Teams established
  • •Constructive interaction on working level successfully implemented

New INN1 name for BT-061

  • •New INN1 name for BT-061: Tregalizumab2
  • • The World Health Organization (WHO) selected a unique and universally available designated name (INN - International nonproprietary name) of worldwide acceptability for identification of BT BT-061
  • •WHO followed Biotest`s suggestion
  • • "lizumab" indicate that BT-061 is an immunmodulating (li) fully humanized (zu) monoclonal antibody ( ) (mab)
  • 1) International nonproprietary name
  • 2) published in WHO Drug Information Vol. 25, No.3, 2011. Recommended INN: List 66

Clinical Development Tregalizumab

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Tregalizumab: Preparation of Phase III Program in Rheumatoid Arthritis

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Basis for Phase III trials

Competitive edge BT-062

Intrinsic properties provide basis for product positioning

1) TAP: Tumor activated payload

BT-062:Overview Clinical Development (Multiple Myeloma)

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Summary Biotherapeutics

Next Stage of Biotherapeutics Implementation Plan Reached

BT-061 (Tregalizumab)

  • • Agreement concluded with partner for Co -Development Development and Co-Promotion
  • •Phase II according to plan
  • •Preparation of Phase III ongoing of

BT-062

  • •Recruitment in multi dose trial in progress
  • •Combination trial to be submitted end of 2011
  • •Planning for trial in Europe ongoing

Outlook Biotest Group

  • •Growing demand for IVIG and albumin (especially in Asian countries)
  • • Stable market for clotting factors
  • •BivigamTM market authorisation expected mid of 2012
  • •Launches of plasma protein products in new markets
  • •Promising R & D pipeline for Plasma Proteins and Biotherapeutics

Contact and Financial Calendar 2011/2012

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