Biotest AG — AGM Information 2010

May 7, 2010

Shareholder's Meeting 2010

Speech by the Chairman of the Board of Management Prof. Dr. Gregor Schulz 6 May 2010

Speech by the Chairman of the

Check against delivery!

Ladies and Gentlemen,

It is my pleasure to welcome you most cordially, on my own behalf and on that of my fellow Board member Dr. Ramroth, to the 2010 Annual Shareholders' Meeting of Biotest AG. We naturally extend our first greetings to you, dear shareholders. Thank you very much for your interest in the development of the Biotest and for your readiness to participate in its development by your decisions.

We are also pleased to extend a warm welcome to the representatives of banks and the media, to the analysts who are present, and to all our other guests.

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2009 – The Highlights

• Plasma protein production capacity doubled in Dreieich
• Start of production operations in the United States
• Approval of Zutectra®
• Biotherapeutics: clear indications of clinical efficacy
• Sales and earnings clearly up on previous year

Let me begin to look at the key events that have occurred in recent months.

In 2009, Biotest made further important progress in implementing strategic projects:

We have expanded our plasma protein capacities significantly. Since early March 2009 we have had twice the annual immunoglobulin production capacity at our disposal. At the end of last year, the new manufacturing plant at our US subsidiary Biotest Pharmaceuticals Corporation (BPC) began operations. With this plant we will be able to manufacture up to 1.5 tonnes of immunoglobulins per year. So compared to the end of 2008, Biotest will nearly triple its immunoglobulin production capacity from 2.0 to 5.5 tonnes.

We also made further additions to our plasma proteins product range. Most important factors were approvals for our preparations in additional European countries and the marketing launch for our hepatitis B immunoglobulin Zutectra®.

In Biotherapeutics we have had clear indications of clinical efficacy for two of our three monoclonal antibodies since 2009. All clinical trials to date have led to good, and in some cases even very good, results. I will give some examples later on.

Last but not least, 2009 was also another very good year in respect of our financial figures. In a year in which many companies were confronted with enormous decreases in sales due to the economic crisis and showed losses, we were able to increase both sales and earnings. Sales were up 14.1% on the previous year and we achieved a 4.2% increase in EBIT.

Medical Diagnostics sold to Bio-Rad

• Sale of transplantation and transfusion diagnostic activities
• Buyer: Bio-Rad Laboratories, Inc.
• Contract signed: 23 October 2009
• Closing on 6 January 2010
• Sale price: €45 million

• Preliminary sales proceeds: €18.1 million (EBIT)

• Biotest Medical Diagnostics GmbH

• Biotest Diagnostics Corp.
• Activities of international affiliates

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Ladies and Gentlemen,

As of 6 January 2010, Biotest sold its transfusion and transplantation diagnostic activities to Bio-Rad Laboratories, Inc. of Hercules, California. This transaction comprised our subsidiaries Biotest Medical Diagnostics in Dreieich, Germany, and Biotest Diagnostics Corporation with headquarters in Rockaway, New Jersey, in the US. In addition, parts of our affiliated companies that were connected with transplantation and transfusion diagnostics were transferred to Bio-Rad as part of an asset deal.

In return for this package the buyer paid the purchase price of €45 million on 6 January 2010. Less transaction costs, the likely expense of restructuring that has yet to be undertaken and the assignment of shareholders' loans, the sale will yield €18.1 million in recognised profit for 2010 in addition to profit from Continuing Operations. After taxes this corresponds to a sum of €15.1 million.

We have used the proceeds of the sale to reduce our financial liabilities. In the medium to long term, we aim to invest part of the proceeds in expanding capacity and to finance research and development.

Ladies and Gentlemen,

I explained the situation of the Medical Diagnostic segment to you at the 2009 Annual Shareholders' Meeting. Although the segment had high-quality products and interesting R&D projects, it was too small overall to hold against increasingly fierce competition in the long term. That is why, in 2008, we started a search for a strategic partner for the segment.

In Bio-Rad Laboratories, Inc. we found just such a partner. Bio-Rad is a globally active provider of life sciences research and clinical diagnostic products. The two partners' competences complement each other ideally. Furthermore, like Biotest, Bio-Rad has strong roots as a family firm and is recognised as pursuing long-term corporate policies that are sound and attach particular importance to ensuring that jobs are safe and stable.

We are convinced that Medical Diagnostics will be able to make better use of its potential under the new owner.

Moreover, Dr. Ramroth and I feel that this transaction confirms our view that with business arrangements of this kind, it is always better to focus on the best alternative rather than to aim for the quickest solution.

We would both like to take this opportunity to thank the management and all staff at Medical Diagnostics for their work over the years – and to wish them all the best in a successful future under the wing of Bio-Rad.

Plasma Proteins

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Ladies and Gentlemen,

Let me now go into greater detail on the major strategic milestones we have reached in the Plasma Proteins segment since the 2009 Annual Shareholders' Meeting.

The strategy for our core business is based on three pillars:

• Expanding our product range by means of new preparations and approvals for further indications

• Opening up new international markets
• And expansion of our capacities in line with demand

We aim in this way to expand our position as a specialist in innovative immunology and haematology.

Major progress in development of Plasma Proteins
	Zutectra®	Europe-wide approval (centralised procedure)
	Hepatect®	Approvals in seven other European countries (mutual recognition procedure)
	Albiomin®	Approvals in six other European countries
Biotest Annual Shareholders' Meeting 2010	Intratect®	Use in fibromyalgia indication: trial completed – scientific publications finalised 7

In December 2009, as expected, we were granted approval by the European Commission to market the new subcutaneous hepatitis B immunoglobulin Zutectra®. The approval applies to the entire European Union.

That was something new for Biotest – it was the first time in our history that we took a drug to approval via the central EU procedure. The procedure went according to plan. In the process, our drug safety department and the entire Medical/Regulatory Affairs division gained valuable experience. This will help us in future proceedings of this kind, be they in Plasma proteins or, viewed on a longer-term basis, in Biotherapeutics.

I will come back to Zutectra® and Biotest's leading position in hyperimmunoglobulins in a moment, but first I would like to present an overview of the other R&D milestones we have reached since the beginning of 2009.

As early as January 2009, Biotest was granted approval for the albumin preparations Albiomin® 5% and Albiomin® 20% in a further six European markets. In April 2009, Hepatect® CP was approved in seven more European countries via the mutual recognition procedure.

In a clinical phase III trial, our polyspecific immunoglobulin Intratect® proved its efficacy for treating fibromyalgia, or chronic pain syndrome. In 30% of patients treated, the pain level was reduced by a clinically relevant amount after treatment with Intratect®. Final data from the trial are now available and will be published in a medical journal.

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Clinical development of the new IgM concentrate began in June last year with a phase I clinical trial. As expected, the findings were good: during treatment and over the 13-week follow-up phase none of the 24 healthy volunteers who underwent treatment suffered from serious side effects. We will most likely start the development of another phase II clinical trial at the end of 2010.

We are developing the IgM concentrate for a range of indications comparable to those for Pentaglobin®, which has already been approved. The focus is on treating serious bacterial infections, such as sepsis. Biotest is the world's only provider of an IgMenriched immunoglobulin of this kind.

A new virus inactivation procedure as well as a new chemical purification process for proteins ensures that along with a higher concentration of IgM, the functional properties are better too.

The additional benefit for Biotest is that we can obtain the raw material for the IgM concentrate from the plasma that we process. The new product will thus further increase our manufacturing efficiency and profitability.

Cytotect®: Trial is progressing

For our immunoglobulin Cytotect®, the phase III clinical trial of using the product to treat cytomegalovirus infection of mothers during pregnancy is still under way. The aim is to prove that by administering Cytotect® a transfer of the virus to the unborn child can be prevented. That is important because a transfer could harm the child, even leading to serious abnormalities. The findings of an interim analysis of the trial will probably be available toward the end of 2010. A decision on the further progress of the project will then be made on the basis of these findings.

In individual cases Cytotect® is already used successfully in this indication.

Official approval is needed to position it for a regular treatment. It is also the basis on which tests for possible cytomegalovirus infection during pregnancy can become a regular feature of prenatal care in the first place.

I think that this description must make it clear that we are discussing an indication with the highest level of ethical significance. That is a further reason why we have initiated an international phase III clinical trial in order to gain approval. In the course of this trial about 5,000 pregnant women have been screened so far. Over the course of the full trial, we anticipate that up to 20,000 immune screenings will be required. In the process, we will check whether or not the pregnant woman has been immunised by a previous infection. We can only include in the actual trial women who have not had a previous infection.

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Zutectra®: Europe-wide approval of first hepatitis B immunoglobulin with subcutaneous administration

Biotest Annual Shareholders' Meeting 2010

Ladies and Gentlemen,

As noted earlier, I would like to deal in greater detail with Zutectra® and Biotest's position as regards hepatitis B immunoglobulins. With Europe-wide approval we now have a preparation in our product range that can provide patients with lasting protection from reinfection after a liver transplantation caused by hepatitis B infection. This is necessary because a reinfection would severely damage the transplanted organ. Patients affected would then suffer from a renewed chronic infection of the transplanted liver within a very short time.

That is why these patients need to be treated with hepatitis B immunoglobulins as a precaution for the rest of their lives.

Zutectra® is the ideal solution. It is injected subcutaneously, i.e. under the skin, it is supplied in pre-filled syringes, and dosed in such a way that patients can administer the dose themselves once a week. That makes this vitally important prophylaxis as easy and gentle as possible.

Hepatect® CP and Zutectra® are an ideal combination

Zutectra® is an ideal complement to Hepatect®, which has already been approved for some time and which is used in high-dosage therapy during and in the first months after transplantation and is administered intravenously by the doctor.

Biotest has thereby further consolidated its position as world market leader in this indication.

Ladies and Gentlemen,

We can call ourselves world market leader because for this indication our products serve 42% of the market. We are also the leading provider in the United States. There, our preparation Nabi-HB® has successfully defended its position as the most important hepatitis B immunoglobulin with a market share of over 50%.

As you know, we acquired Nabi-HB® along with the US plasma protein business we acquired at the end of 2007. That business has since been handled by our subsidiary Biotest Pharmaceutics Corporation, or BPC for short. For us, BPC is the platform on which we are building up our business in North America step by step.

Today, our Plasma Proteins business has already moved into entirely different dimensions from where we were before acquiring BPC. Segment sales in 2009 were more than 60% higher than in 2007. Viewed over a five-year period, we have increased our Plasma Proteins sales by nearly 150%. In the years ahead we anticipate further substantial growth, generated mainly by our US business. This is because we are opening up the world's most attractive market for immunoglobulins by developing this business.

There are two main reasons for this high level of attractiveness:

The first is the sheer size of the market: the United States accounts for 40 tonnes, or more than 40% of annual world demand for immunoglobulins. That is due largely to the per capita consumption of immunoglobulins being significantly higher in the United States than elsewhere. Compared to Germany, for example, it is nearly three times as high.

One of the main reasons for this is that immune diagnostics is much more prevalent in the United States. In this field Europe in general, and countries such as the UK and Germany in particular, have a substantial amount of ground to make good for.

The other factor that makes the US market so attractive is the high price level there: in 2009 the average price for a unit of intravenous immunoglobulin in the United States was \$70. In Europe, the price ranged from €35 to €52.

US manufacturing plant in operation since end of 2009

• State-of-the-art manufacturing facility at Biotest Pharmaceuticals Corp. (BPC) in Boca Raton, Florida
• Fractionation: 400,000 litres per annum
• Immunoglobulin production: 1.5 tonnes per annum
• Plasma collection at 10 BPC-owned plasma collection centres

Biotest Annual Shareholders' Meeting 2010

That is why we at Biotest are investing in a further strengthening of our presence in the United States. We have already successfully completed the first phase: on 26 December 2009 the new manufacturing plant began operations at BPC. Final work on the corresponding storage and service facilities is now under way. We will then have at our disposal in Boca Raton a fully equipped production facility capable of processing around 400,000 litres of blood plasma and manufacturing 1.5 tonnes of immunoglobulins a year. We can produce the quantities of blood plasma required in full at our ten donor stations in the United States.

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BivigamTM (IVIG) development nears successful completion

Polyspecific immunoglobulin with a wide indication range (incl. antibody deficiency and autoimmune diseases)

• A polyspecific immunoglobulin comparable to Intratect®
• Clinical development: successful conclusion of phase III
• Production of stability batches completed

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• Submission of approval documents in Q3 2010, approval likely in Q3 2011
• Sales potential after approval: around \$100 million per annum

Biotest Annual Shareholders' Meeting 2010

Along with Nabi-HB® we will be producing in Boca Raton the new intravenous immunoglobulin (IVIG), developed for the US market. Its properties are comparable to those of Intratect®, for which we have approval in Europe and other markets outside of the United States.

We have recently received registered trademark rights for this preparation. In the future, IVIG will be marketed under the name BivigamTM, of which we have already manufactured the first batches at our new production facility. These will have to prove that the product is biochemically stable, which is a precondition for securing approval.

Clinical development was completed successfully at the same time. The final medical report of the phase III clinical trial and the required documentation on the production process are currently being prepared. Together with the stability test data, they are the principal constituent parts of the approval dossier.

We will be submitting the dossier in the third quarter of 2010 to the US approval authority FDA, and we anticipate approval of BivigamTM in the third quarter of 2011.

Based on the current market price of around \$70 per gram, potential annual sales of Biotest immunoglobulins in the United States could amount to around \$100 million. The full potential should take effect in the year 2012.

Our US activities will have a significant positive effect on our results much earlier, however. With the newly established production alliance network between Dreieich and Boca Raton we will enhance our efficiency substantially.

One of the main reasons for this is that we can make use of preliminary and intermediate products made in the United States at our manufacturing plant in Dreieich. They are, specifically, the raw materials for albumin and for our factor VIII preparation Haemoctin®. At present we still need to buy in raw materials for this but in the future we will no longer need to do so to the same extent.

This move alone should enable us to improve our margin on plasma proteins by about two percentage points.

CivacirTM: Attractive project is put on course

Ladies and Gentlemen,

I feel this outline makes it clear that the decision to purchase our US activities was absolutely the right one.

Also, BPC has with CivacirTM another highly promising development project in the pipeline. CivacirTM is being developed for use as a hepatitis C reinfection prophylaxis after liver transplantations. We aim to secure approval for the preparation in the United States and Europe and in selected Asian and South American markets.

The number of liver transplantations as a result of a hepatitis C infection differs by region and is about five to ten times higher than those due to a hepatitis B infection. So for Biotest, CivacirTM represents significant long-term sales potential.

After we had taken over CivacirTM as an R&D project that was already under way, our initial focus was on optimising the production process and the product's consistency. The aim was to ensure that we always achieve the optimal concentration of antibodies in the finished preparation.

We largely completed this process at the end of 2009. Our aim is now to reconfirm these results in further pre-clinical trials before proceeding with clinical development. From today's perspective we expect this to be the case in 2011.

Ladies and Gentlemen,

The immunoglobulins business at Biotest can be divided into two product areas. The one consists of polyvalent immunoglobulins such as Intratect® or BivigamTM. These are used across a wide range of indications.

The other consists of special preparations –known as hyperimmunoglobulins – designed for therapy and prophylaxis for specific disorders.

They already account for about 30% of our sales of plasma proteins. None of our direct competitors commands a comparable market share. Our world market share is currently around 15% and it is projected to increase to nearly 18% over the next four years.

To make such specialised products you need, in addition to the necessary expertise, the right raw material. For hepatitis B immunoglobulins, for example, you need plasma with an especially high antibody titre count, which is only to be found in a minority of donors. Building up a base of suitable donors takes a long time and requires substantial investment.

Biotest has such a donor base. We are, for example, able to meet our hepatitis B plasma requirements in full from our own sources.

Alongside the barriers to market entry another reason for these special preparations' stable and high margins is that they are less attractive for very large manufacturers who set their sights on mass markets.

That is why we will continue to work on staying ahead of the pack with these preparations. In the process, we will carry on networking our activities in Europe and the United States: In the medium to long term we will aim to market

immunoglobulins that already have approval in Europe in the United States. And on the other side, CivacirTM also has great potential in the EU.

Demand for immunoglobulins is increasing and will continue to increase in the years ahead – we anticipate annual growth rates of 5 to 6%. The important growth drivers are expansion of the indication range, generally higher dosages per patient and the opening up of new regional markets in developing and emerging countries.

Those of you who follow Biotest very intensively will know that we pointed out at a very early stage that this rising demand has for some time been facing a supply that is growing even faster.

Between 2005 and 2009 the collection volume at plasma donor stations in the United States rose on average by 20% per annum – and this capacity is a key indicator of world supply. So it was to be expected that the demand surplus of past years would be reduced, as it has been now, and that in a number of submarkets we now have a supply surplus.

That, of course, could not fail to exert an influence on prices. Individual submarkets have seen prices fall significantly for certain products. In other regions and product categories, prices have, however, remained stable to this day. Cyclical fluctuation between supply and demand is well known to the industry. Due to lengthy production times, the amount of plasma collected and processed cannot be adjusted at short notice. Since mid-2009 we have noted a decline in plasma collection capacities. At the end of 2009 the monthly volume of plasma collected was lower than in the previous year. As this influences the availability of end products in the medium term, we anticipate a gradual rise in prices for these from 2011 on.

That, however, means we will face a more difficult market environment this year and next. We responded early to the change in trend that was on the horizon and adjusted our production volume accordingly.

I will explain later the possible consequences for Biotest's sales and earnings prospects.

One or another of you may now wonder why Biotest is expanding its immunoglobulin capacity so strongly in this market environment. We do not see this as a contradiction, for three reasons:

First, because Biotest has in the recent past been limited in the amounts of certain products that it had at its disposal.

Second, because demand for plasma proteins continues to rise – just, by the way, as it does for immunoglobulins and coagulation factors.

And, third, because the establishing of the production facilities in the United States provides the opportunity to make use of the enormous potential of this market. In terms of the overall market for immunoglobulins in the United States – the 40 tonnes mentioned earlier – BPC's capacity accounts for less than 4% of the total. That is less than annual market growth, which is running at approximately 5%.

Ladies and Gentlemen,

In the plasma proteins business Biotest has worked at improving its position. Further opportunities have been and continue to be our commitment in the United States and expanding our product range, particularly by adding special preparations. We have an attractive development pipeline, and with the newly created production network we will become significantly more efficient in manufacturing. All of this will enable us to do business successfully, even in today's difficult market environment.

Biotherapeutics

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By developing monoclonal antibodies, Biotest is extending its activities in immunology and haematology in the biotherapeutic sector.

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Apart from the French LFB, we are the world's only manufacturer of plasma proteins that is making use of its competences in this respect and developing them further. As the lead indications of our three monoclonal antibodies are immune or blood diseases, in developing them, we can fall back on our experience and our network in the field of plasma-based products.

The lead indications for BT-061 are rheumatoid arthritis and plaque psoriasis, for BT-062 multiple myeloma and for BT-063 systemic lupus erythematosus, an autoimmune deficiency.

All three antibodies have two points in common:

As mentioned above, they are being developed for indications in which a high medical need exists for new, effective and tolerable treatments.

Furthermore, their mechanism of action differs significantly from alternative therapies approved and under development.

As a consequence, the market potential for new drugs in these indications is high. In all areas, the annual growth rate is in double-figure percentages, namely between 13% and 18%. The market for drugs to treat rheumatoid arthritis will grow to nearly \$18 billion by 2012. Growth will mainly be triggered by new biological therapeutics such as monoclonal antibodies. For multiple myeloma the market potential is expected to increase to nearly \$8 billion.

Here, you can see our current development timetable for Biotherapeutics. Since 2009 all three monoclonal antibodies have been in clinical development: BT-061 is developed furthest, with phase II clinical trials now under way for the lead indications of rheumatoid arthritis and plaque psoriasis.

BT-062 is currently undergoing a phase I clinical trial in the United States. A further phase I/IIa clinical trial has already been approved by the FDA and will be launched later this year. And for BT-063 the first phase I clinical trial – a trial of its tolerability in healthy people – began at the end of 2009.

Last year at this point I reported initial findings of a phase IIa clinical trial on BT-061 in rheumatoid arthritis. They suggest that the antibody alone brings about a considerable improvement in the so-called ACR score, an indicator of the clinical progression of rheumatoid arthritis. We expect the final evaluation of this trial in the late summer of 2010 now that the last trial patient has commenced treatment.

In the meantime, data from another phase II clinical trial has now become available. It involved testing BT-061 in combination with methotrexate, or MTX for short. Methotrexate is currently the most widespread basic therapy used to treat rheumatoid arthritis. In the trial, the effect of BT-061 in combination with MTX is to be compared to the effect of MTX alone. To compare the effect, some of the patients are treated with BT-061 and methotrexate while others, the control group, are given methotrexate on its own.

Analysis of initial data from the ongoing trial has shown that patients treated additionally with BT-061 achieved markedly better therapy results than the control group. This data relates to intravenous administration of BT-061. The effect of the antibody when administered subcutaneously is being tested in the second part of the trial. These results are estimated to be available in the second half of 2010.

But even on the present basis, the data indicate for us a clear proof of concept for BT-061 in the indication of rheumatism.

As the next development step we will be submitting in the weeks ahead the documentation for approval of a phase IIb clinical trial. Its aim is to gather further efficacy and tolerability data for subcutaneous administration and to determine the optimal antibody dosage.

If the trials – new and in progress – continue to be so successful, we will most probably be able to initiate phase III clinical trials on the basis of the findings gained. That, however, will not be before 2012.

For plaque psoriasis the second lead indication for BT-061, we have also been able to gather trial data that gives us an initial indication of clinical efficacy. Seventy-five days after subcutaneous administration of 25 mg of BT-061, an improvement by at least 50% was noted for 60% of patients. For 20% of patients who were given this dose, the improvement was at least 75%. These improvements are by PASI scores of 50 and 75, respectively. PASI scores (Psoriasis Area and Severity Index) are used all over the world to determine how serious the psoriasis is. They describe the average redness, thickness and scaling of the skin affected, weighted by the size of the area the psoriasis covers.

We also have similarly encouraging indications of efficacy for BT-062.

As multiple myeloma is a cancer of plasma cells for which there is at present no cure, we are able to administer this antibody to patients as early as phase I clinical trials.

In this way we are able to gather data about efficacy, in addition to the focus on information about tolerability. And this data is very good: in 53% of patients, progress of the tumour was arrested for more than six weeks, and in one case for as long as 30 weeks.

We are presenting the findings available to date at the annual congress of the American Society of Hematology (ASH), one of the most renowned medical conferences in the world that deals with this indication.

Trial participants: Patients with a long history of illness

For ethical reasons tests so far only on seriously ill patients

Patients whose illness has relapsed / patients on whom other treatments have had no effect

On average, patients have suffered from their illness for six years and have already undergone intensive previous treatment*

• (Up to) 15 rounds of chemotherapy with different cytostatic drugs
• Stem cell transplantations (over 50% of participants)

In later stages, patients with shorter illness histories and fewer previous therapies included in trials

Thus increasing likelihood of even better efficacy

* Median: 8 previous therapies

Biotest Annual Shareholders' Meeting 2010 29

What makes these results so extraordinarily positive is the fact that the patients involved in the trial are people who are seriously ill. For them, other approved therapies have either had no effect or the patient has suffered a relapse. So the people involved have been suffering from multiple myeloma for several years and have on average already undergone eight courses of treatment:

They had all endured several different chemotherapy treatments, and more than half of them had been given stem cell transplantations. Yet in all cases the treatment was unable to bring the illness to a long lasting halt.

As you can see, we are now able to base our confident assessments of the potential of our monoclonal antibodies on increasingly firm foundations supported by clinical data. That also applies to BT-063, for which the current phase I clinical trial has shown it to have good tolerability.

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Biotherapeutics: Established own production capacities

Development structures in the segment:

• GMP production of monoclonal antibodies established in Boca Raton (BPC)
• Manufactured first large-scale batches of BT-061 in own production facility

Gradual further establishment of teams in Drug Development

Biotest Annual Shareholders' Meeting 2010

Ladies and Gentlemen,

Along with pre-clinical and clinical development we are taking the establishment and expansion of structures in the Biotherapeutic segment further forward. We have, for example, continued to strategically reinforce our teams and thereby to recruit additional expertise for Biotest.

Furthermore, in 2009 we set up the BT-061 production process at the BPC site and manufactured our first large-scale batches. The assets acquired along with the takeover of Nabi in 2007 included a production facility for genetically engineered vaccines, which we were able to convert. In the meantime, the first batches of BT-061 have now been produced on a scale of 2,000 litres in Boca Raton.

In keeping with its Plasma Proteins approach, Biotest will also cover the entire value chain in the Biotherapeutic segment.

BT-061 partnership

• Talks with international pharmaceutical companies
• High level of interest
• Desire for confirmation of positive trial results via further phase II clinical trials
• Stand-alone further development of mAb until agreement is reached Biotest strategy:

Biotest Annual Shareholders' Meeting 2010 31

Yet we would still like to share development from clinical phase III onward as well as approval and marketing of monoclonal antibodies with a partner.

At last year's Annual Shareholders' Meeting I informed you that we had initiated a search for a suitable partner for BT-061. This process is still under way and we have already held intensive discussions with groups that operate all over the world. The response has been positive. Keen interest was shown in the trial results available to date, and the partnership and marketing concept that we envisage has met with approval.

Before concluding an agreement, however, potential partners would like to wait and see further findings of current phase II trials and to see the positive properties of BT-061 confirmed in trials involving a wider group of patients.

For us this means that we must first continue to take the development of monoclonal antibodies forward under our own responsibility. We have the necessary expertise and organisational, technical and financial resources for this at our disposal.

The structure of any cooperation agreement on monoclonal antibodies will determine how well we are able to make use of the great potential of these new agents for Biotest. That is why we are proceeding particularly carefully and thoroughly and will definitely not be aiming to conclude an agreement at any price – that would fail to acknowledge the interests of Biotest and the value of the projects.

In Biotherapeutics a later agreement may prove beneficial for Biotest for another reason: the more clinical data is available, the greater the value of the projects. That holds true even more so if the trials continue to deliver such good results as the course of findings to date would appear to indicate.

Ladies and Gentlemen,

I think that what I have said so far makes it clear that Biotest continues to be heading in the right direction, both in its core plasma proteins business and in developing biotherapeutics. All of us at Biotest will continue to work on expanding our position as a specialist in the therapy and prophylaxis of complex immunological diseases.

Before I go on to outline details of sales, earnings and financials for 2009, I would like to deal briefly with developments in the Microbiological Monitoring segment.

Biotest Annual Shareholders' Meeting 2010

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In our business in products for hygiene monitoring we have succeeded in increasing sales by 8% year on year and in maintaining – and in some cases expanding – our position in important markets. This growth was again due to the success of our affiliated company heipha Dr. Müller, in which Biotest holds a 51% equity stake. Sales in the segment's second line of business, the products in the Biotest HYCON series, were maintained at the previous year's level.

We are investing in this segment too:

• In 2009, for example, we took into service the enlarged logistics capacities at the heipha location in Eppelheim, near Heidelberg.
• We also took various R&D projects forward. One I would like to mention is a Biotest HYCON project that significantly speeds up the identification of atmospheric and surface bioburdens by means of PCR technology.
• And we have also further reinforced our sales teams in the United States and Japan.

This all establishes the basis for Microbiological Monitoring continuing to develop successfully in spite of a market environment that here too has grown more difficult.

In addition to the measures mentioned, we strive to further improve the segment's profitability. In doing so, we are, amongst other things, looking into whether strategic cooperations might be a sensible move.

Ladies and Gentlemen,

Let me now explain the key financial indicators for 2009. All of the following figures relate to the Biotest Group's Continuing Operations.

The transfusion and transplantation diagnostic activities are recognised as a Discontinued Operation due to the decision to dispose of them that was taken in October 2009.

Most of the remaining parts of the former Medical Diagnostic segment were transferred to the Microbiological Monitoring segment. The figures for the previous year have also been adjusted accordingly.

In 2009, Biotest revenue again reached a record figure at €440.2 million. Compared to the previous year that was an increase of 14%. Revenue in Plasma Proteins for 2009 was nearly 15% higher than in the previous year, while Microbiological Monitoring, as just mentioned, reported a revenue increase of 8%.

EBIT, the Group's operating profit, was also above guidance at +4.2%. By this we achieved again the previous year's excellent level.

The fact that the EBIT increase was below the figure for revenue growth was due to three effects.

First, reconstruction work at the Boca Raton plasma proteins manufacturing plant led to vacancy and amortisation costs. Second, rising raw material costs burdened the result, especially in the first half of the year. And third, falling prices in the second half of the year made write-downs on inventories necessary.

In the development of the Group's pre-tax earnings you will note what is, compared to EBIT, a disproportionately higher growth of 7.7%. This was a consequence of the improved financial result. Which in turn was due mainly to lower interest payments.

Nevertheless, earnings after taxes were slightly down on the previous year because the 34.9% tax rate in 2009 was much higher than that of the previous year. In 2008 it was 28.1%. There were a number of reasons for the increase. One was that we incurred higher non-deductible expenses.

After taking minority interests into account, earnings per ordinary share were €2.49 in 2009, and including the additional dividend entitlement of 6 cents, earnings per preference share were €2.55.

The slight declines in the EBIT margin and return on capital employed reflect the below-average EBIT growth and the increase in current assets.

The latter effect can also be noted in the structure of the statement of financial position. You will see it on the assets side in the higher year-on-year volume of current assets and on the equity and liabilities side, in the increase in current liabilities.

The temporary build-up of current assets due to larger inventories is typical of Biotest's business. In connection with approval procedures, for example, we have to manufacture production batches and store them for several months in order to demonstrate their stability.

The volume of receivables in the 2009 statement of financial position is only slightly below the figure for the previous year. This development is due mainly to the increased use of factoring and to our stringent receivables management.

Ladies and Gentlemen,

I have already explained why we anticipate a more difficult market environment for our core business in plasma proteins this year than in the recent past. Along with these industry-typical effects resulting from more extensive supply, the economic crisis and its consequences will have an impact on developments in 2010 and probably also 2011.

Our products are, of course, life-saving drugs and thus do not face the threat of a slump in demand. In view of the poor state of public sector budgets, however, there will probably be further efforts to make savings in state healthcare systems around the world. What is more, many of the supply agreements in our industry are concluded on a long-term basis. This means that the changed market situation is only now beginning to take its full effect.

Q1 2010: Sales and earnings in line with expectations

The information that is available to us so far about business developments in Continuing Operations in the first few months of 2010 confirms our assessment of the situation. According to preliminary figures, sales in the first quarter of 2010 were 5.2% higher than in the first three months of 2009. In contrast to last year the Microbiological Monitoring segment grew at a significantly swifter rate than the Group's Plasma Proteins business. EBIT at the end of the first quarter was €12.3 million and thus €2.7 million or 18% lower than in the previous year. The reasons were, for one, that substantial price declines for immunoglobulins in a number of European core markets led to lower profitability, and that, although we were able to maintain our market share for coagulation factors in Russia, we were forced to make price concessions there too in order to do so. And, third, research and development expenses increased significantly.

The Biotest Group's profit after tax in the first quarter of 2010 was nearly three times as high as in the same period of the previous year. It rose from €7.7 million to €22.6 million. This figure includes €15.1 million from the sale of the Group's Medical Diagnostic business.

We are publishing the report for the first quarter with the final figures and corresponding notes next Tuesday, 11 May.

42

Biotest's business environment fundamentally attractive and stable:

• Products often life-saving treatments long-term demand independent of cyclical effects
• Biotest's business is regionally diversified
• Growth opportunities in industrialised countries and emerging markets

But there are grounds for caution:

• Difficult funding situation of public sector healthcare systems
• Higher credit and default risks in some markets

Our targets for 2010:

• Low single-digit percentage sales growth
• EBIT at 2009 level

Prerequisite:

– No further price decreases

– More sales in high-margin markets

Biotest Annual Shareholders' Meeting 2010

The market environment changes described, along with continued uncertainty as to further economic developments, are reason enough for us to act with increased caution in setting targets for 2010 in spite of what continues to be a fundamentally stable and attractive environment for Biotest.

Based on the developments in the first three months of 2010, the Board of Management reaffirms the targets set for the full year 2010 in the 2009 Annual Report. Biotest continues to expect sales growth in the low single-digit percentage range and anticipates an operating profit (EBIT) at the 2009 level, provided that no further price reductions occur and that we succeed in selling more of our products in less price-sensitive markets.

Our forecast relates solely to Continuing Operations. It therefore takes into consideration neither the one-off effects of the Medical Diagnostics sale nor possible income from the conclusion of a cooperation agreement in the Biotherapeutic segment.

Ladies and Gentlemen,

Compared to last year's Annual Shareholders' Meeting, Biotest ordinary and preference share prices are now quoting about 10% or 21% higher.

After the share price had performed better for several years than the respective benchmark, share price growth between May 2009 and May 2010 was lower than the growth achieved by the SDAX index. However, it must be borne in mind that the index experienced a severe loss of value last year, whereas the Biotest share price remained stable over the 12-month period. Viewed over a three-year period, Biotest shares have clearly outperformed the index – and even more clearly so over a five-year period.

We are convinced that Biotest's operational strength in its core business, combined with its R&D projects, make the share an attractive investment. And we will continue to work on ensuring that this is reflected in how the share price progresses.

Ladies and Gentlemen,

With my remarks I wanted to inform you about the current situation of the Biotest Group, the progress of our strategic projects and the Group's future prospects. I hope you have gained a sufficient insight. Dr. Ramroth and I will be available afterwards to answer your questions.

Before I give you a brief explanation of three items on today's agenda, I would like, on behalf of all of the members of the Board of Management and the Supervisory Board, to thank the employees of Biotest Group for their work over the past twelve months. We are especially grateful to everyone who has supported the necessary changes, be they in connection with the sale of Medical Diagnostics or with the changes in plasma proteins production, with a high level

of flexibility and commitment. I feel sure that you will join me in extending this gratitude to our employees.

Furthermore, I would like to thank our business partners, our supporting banks and our customers.

Looking at agenda item 2, the Board of Management and the Supervisory Board would like to propose distributing from the net profit earned in financial year 2009 a dividend of 34 cents per ordinary share and 40 cents per preference share. Compared to the previous year's dividend payment this is an increase of 4 cents per share, or more than 11%.

Despite of the fall in profit after tax from Continuing Operations, we consider the dividend increase to be appropriate. It must in part be seen against the background that we are distributing to shareholders a share of the profit from the sale of Medical Diagnostics.

This means that a quarter of the net profit for 2009 would be distributed to shareholders, leaving the remainder to be carried forward and invested in the Company's future development.

Agenda items 8 and 9

Agenda item 8: Authorised Capital 2010/1	Agenda item 9: Authorised Capital 2010/II
ƒ Capital increase by up to €3.7 million through issuance of new preference shares ƒ Increase on one or more occasions ƒ Subscription right for existing shareholders ƒ Term until 5 May 2015	ƒ Capital increase by up to €3.0 million through issuance of new preference shares ƒ Increase on one or more occasions ƒ Subscription right may be excluded ƒ Term until 5 May 2015
Authorised capital ensures flexibility in future entrepreneurial decisions No current plans for a capital increase
Biotest Annual Shareholders' Meeting 2010	45

With agenda items 8 and 9 we would like you to approve the creation of a new authorised capital from which to issue preference shares.

Item 8 deals with the approval of increasing the share capital by up to €3.7 million through the issuance of new preference shares, for which existing shareholders will have subscription rights. Item 9 requires your approval of a further capital increase involving the issue of up to €3.0 million in new preference shares. The subscription rights of existing shareholders may be excluded if the new shares' percentage of the share capital prior to the resolution does not exceed 10%. Both authorisations for the capital increases would run for five years, or until 5 May 2015.

By creating authorised capital we would like to gain scope for raising additional funding insofar as this might be appropriate for the further development of the Company. We have no immediate plans to do so.

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Conclusion: 2009 – Another successful year for Biotest

Biotest Annual Shareholders' Meeting 2010

Ladies and Gentlemen,

Despite of a markedly more difficult market environment, 2009 was a further successful year for the Biotest Group. We achieved the goals that we had set ourselves and made important progress in all strategic projects. That makes us feel confident of achieving good results in 2010 and 2011 – even though the market environment is more than likely to remain difficult in both years.

In my name and in that of my fellow director and the members of the Supervisory Board, I would like to thank you, dear shareholders, for the constructive way in which you have accompanied us in the past. We would be delighted if you were to continue to be loyal to Biotest as shareholders.