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Biotest AG Interim / Quarterly Report 2016

May 12, 2016

66_10-q_2016-05-12_9ca692e4-0c89-4a3e-bdfd-15216abf6bbc.pdf

Interim / Quarterly Report

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QUARTERLY STATEMENT AS OF 31 MARCH 2016

KEY FIGURES

BIOTEST GROUP Q1 2016 Q1 2015 Change in%
Revenue € million 147.1 142.5 3.2
thereof:
Germany € million 28.4 32.2 -11.8
Rest of world € million 118.7 110.3 7.6
thereof:
Therapy € million 100.3 98.3 2.0
Plasma & Services € million 44.8 42.2 6.2
Other Segments € million 2.0 2.0 0.0
EBITDA € million 14.3 7.7 85.7
Operating profit (EBIT) € million 8.6 0.1 8,500.0
EBIT in% of revenue % 5.8 0.1
Earnings before taxes € million 4.7 4.2 11.9
Earnings after taxes € million 1.8 1.4 28.6
Financing
Cash flow from operating activities € million 18.3 12.6 45.2
Depreciation and amortisation € million 5.7 7.6 -25.0
31 March 2016 31 December 2015
Equity € million 410.1 412.3 -0.5
Equity ratio % 42.4 42.8
Employees (full-time equivalents) FTE 2,324 2,271 2.3

CONTENTS

  • 3 Foreword
  • 4 Business performance
  • 4 Research and development
  • 5 Marketing and distribution
  • 5 Supplementary report
  • 5 Outlook, risk and opportunities report
  • 6 Consolidated Statement of income
  • 6 Consolidated Cash flow statement
  • 7 Consolidated statement of financial position
  • 8 Acknowledgements

KEY SHARE FIGURES

Ordinary share

Ticker / ISIN BIO/DE0005227201
Number of shares 19,785,726
Closing price (31 March 2016)* € 16.82
Highest / lowest price* € 18.00/€ 11.91
Share price performance Q1 -6.56%
Performance SDAX Q1 -1.44%
Market capitalisation (31 March 2016) € 332.8 million

Preference share

Ticker / ISIN BIO3/DE0005227235
Number of shares 19,785,726
Closing price (31 March 2016)* € 14.72
Highest / lowest price* € 14.93/€ 10.40
Share price performance Q1 + 0.75%
Performance SDAX Q1 -1.44%
Market capitalisation (31 March 2016) € 291.2 million

*Closing prices on Xetra trading system at Deutsche Börse AG

FINANCIAL CALENDAR

11 August 2016 Half-Year Report 2016
10 November 2016 Quarterly statement as of 30 Sep 2016

1 Jan 2016 31 Mar 2016

Ladies and gentlemen,

In the first quarter of 2016 we recorded encouraging increases in revenue and operating profit(EBIT) compared with the same period in the previous year.

Ourfocus in the first quarter was implementing our new Group strategy. In the future, we will concentrate on the plasma protein business. We will continue our commitment in the area of monoclonal antibodies until the next milestones are reached. During this time, we intend to identify suitable partners for future development and marketing.

Also in the plasma business we will strengthen our focus on partnerships. The cooperation agreement with Kedrion Biopharma Inc., USA, concluded in January 2016 is a good example of a new partnership. Kedrion Biopharma will take over the exclusive distribution of Bivigam® in the USA until the end of 2022 and is guaranteeing Biotest minimum purchase quantities. We expectthe cooperation to improve profits by USD 4 to 5 million in the 2016 financial year.

The Biotest Next Level projectis a core element of our strategy. With the € 250 million that we are investing within the scope of the project, we are expanding the product portfolio of plasma proteins and doubling production capacity inDreieich. That will lead to a substantial increase in profitability.

Based on the development pipeline with promising projects and the strategic realignment, we anticipate a positive development in the future. We expect an increase in sales in the low single-digit percentage range for 2016. We anticipate a total EBIT in the range of € 33 to 35 million.

Cordially yours,

Dr Bernhard Ehmer Chairman of the Board of Management

BIOTEST SHARE PRICE CHART

110%

100%

80%

60%

70%

90%

Ordinary share Preference share SDAX (performance)

BUSINESS PERFORMANCE

A. AT A GLANCE

Results of operations

In the first quarter of 2016, the Biotest Group generated revenue of € 147.1 million, after € 142.5 million in the same period ofthe previous year. This corresponds to a percentage increase of 3.2%. All segments contributed to this positive development. The Plasma & Services segment recorded the strongest sales increase with 6.2%.

SALES BY SEGMENT
-- -- -- ------------------
in € million Q1 2016 Q1 2015 Change in%
Therapy 100.3 98.3 2.0
Plasma & Services 44.8 42.2 6.2
Other Segments 2.0 2.0 0.0
Biotest Group 147.1 142.5 3.2

In the regional analysis, Biotest generated sales growth in the regions Rest of Europe, Central and South America, Middle East and Africa, as well as Other Asia and Pacific. In the Other Asia and Pacific region, revenue doubled to € 15.8 million, meaning that 10.7% of total sales were generated in this region. Sales decreases of € 3.8 million and € 6.0 million were recorded by Biotest in Germany and in the USA.

EBIT at Group level increased in the first quarter of 2016 to € 8.6 million (same period in the previous year: € 0.1 million). The EBIT margin amounted to 5.8% after 0.1% in the previous year. While Biotestrecorded an EBIT of € -6.4 million last yearin the core segment Therapy, operating income was positive in the first three months of 2016 at € 0.5 million. EBIT in the Plasma & Services segment rose by 18.3% to € 8.4 million.

EBIT BY SEGMENT

Biotest Group 8.6 0.1 8,500.0
Other Segments -0.3 -0.6 50.0
Plasma & Services 8.4 7.1 18.3
Therapy 0.5 -6.4 107.8
in € million Q1 2016 Q1 2015 Change in%

Cash flow

The BiotestGroup again recorded a positive operating cash flow of € 18.3 million in the firstthree months of 2016 (same period in the previous year: € 12.6 million). Cash flow from investing activities adjusted for financial assets as part ofthe short-term financial planning amounted to € -27.8 million (same period in the previous year: € -10.8 million). Cash flow from financing activities amounted to € 6.6 million (same period in the previous year: € 6.8 million).

Financial position

On the assets side ofthe statement of financial position, property, plant and equipmentincreased due to investments as part ofthe Biotest Next Level expansion projectfrom € 317.2 million as of the reporting date 31 December 2015 to € 341.0 million.

B. RESEARCH AND DEVELOPMENT

Research and development costs decreased by 26.3% in the first three months of the 2016 financial year to € 13.7 million (same period in the previous year: € 18.6 million). This reflects the reduction of activities in the area of monoclonal antibodies. A comprehensive list of all research and development projects is provided in the 2015 Annual Report(pages 16 to 19). Biotest also made significant progress in a number of projects in the first quarter of 2016:

Indication Area Intensive Care Medicine
IgM Concentrate • Phase II study with patients with severe com
munity acquired pneumonia (sCAP) comple
ted with good results: extraordinary relative
reduction in mortality rates in a subgroup of
patients (patients with a significant elevation
in inflammatory markers) of over 50%
• Biotest is evaluating different indication possi
bilities for further clinical development and a
phase III study
Pentaglobin® • Pentaglobin® is showing impressive results
in the treatment of donor-specific antibodies
following lung transplantations
• In a study by the Medizinische Hochschule
Hannover (Hanover Medical School), a rela
tive reduction in the mortality rate of over
70% was achieved for patients treated with
Pentaglobin®

C. MARKETING AND DISTRIBUTION

A list of significant marketing and distribution activities in 2015 is provided in the 2015 Annual Report (pages 19 to 20). The following table summarises the progress made in Q1 2016:

PROGRESS IN Q1 2016

Indication Area Clinical Immunology
Intratect® 50 g/l • Marketing authorisation received in Brazil
(5%) • Start of marketing planned for mid 2016
Intratect® 100 g/l
(10%)
• Marketing authorisation received in Jordan
Zutectra® • The results of the ZEUS (Zutectra Early Use)
study were published in March 2016, the
study was completed successfully
• The early use of Zutectra® was started in
Germany
• Negotiations are ongoing in other European
markets. Further market launches, including
in Italy, are expected in 2016
Indication Area Intensive Care Medicine
Pentaglobin® • Market launch in Brazil
Albiomin®
(20% and 5%)
• Start of marketing in Switzerland planned for
the second half of 2016

D. SUPPLEMENTARY REPORT

There were no events with a material influence on the results of operations, financial position and cash flow after the reporting date.

E. OUTLOOK, RISK AND OPPORTUNITIES REPORT

I. CHANGE IN OUTLOOK REPORT

The Board of Management continues to expect an increase in sales in the low single-digit percentage range for 2016.

On 23 March 2016, Biotestincreased the EBIT forecastfor 2016 by more than 10%. The Company now expects an EBIT in the range of € 33 to 35 million. In November 2015, Biotest issued an EBIT forecast of € 30 million.

II. RISK REPORT

The Biotest Group's risk situation has not changed materially from the presentation set outin the 2015 Annual Report(pages 27 to 33).

III. OPPORTUNITIES REPORT

The Biotest Group's opportunities situation has not changed materially from the presentation set out in the 2015 Annual Report (pages 33 to 34) with the exception of the aforementioned cooperation agreement with Kedrion Biopharma.

CONSOLIDATED STATEMENT OF INCOME

of the Biotest Group for the period from 1 January to 31 March 2016

in € million Q1 2016 Q1 2015
Revenue 147.1 142,5
Cost of sales -101.1 -98.1
Gross profit 46.0 44.4
Other operating income 0.7 1.1
Marketing and distribution costs -14.5 -17.9
Administrative expenses -9.3 -8.2
Research and development costs -13.7 -18.6
Other operating expenses -0.6 -0.7
Operating profit 8.6 0.1
Financial result -3.9 4.1
Earnings before taxes 4.7 4.2
Income taxes -2.9 -2.8
Earnings after taxes 1.8 1.4
Attributable to:
Equity holders of the parent 1.8 1.4
Non-controlling interests 0.0 0.0
Earnings per share in €* 0.05 0.11

*Previous year figure adjusted to the new number of shares

CONSOLIDATED CASH FLOW STATEMENT

of the Biotest Group for the period from 1 January to 31 March 2016

Q1 2016
in € million
Q1 2015
Operating cash flow before changes in working capital
14.4
8.3
Cash flow from changes in working capital 7.5
17.1
Interest and taxes paid
-3.6
-12.8
Cash flow from operating activities
18.3
12.6
Cash flow from investing activities
42.2
-74.9
Cash flow from financing activities 6.6
6.8
Cash changes in cash and cash equivalents
67.1
-55.5
Exchange rate-related changes in cash and cash equivalents
-0.4
1.1
Cash and cash equivalents on 1 January
53.8
179.4
Cash and cash equivalents on 31 March
120.5
125.0
thereof cash flow from investing activities
from changes in other financial assets
70.0
-64.1
Cash flow from investing activities adjusted for financial investments
in the scope of short-term financial disposition
-27.8
-10.8

CONSOLIDATED STATEMENT OF FINANCIAL POSITION

of the Biotest Group as of 31 March 2016

in € million 31 March 2016 31 December 2015
ASSETS
Non-current assets
Intangible assets 42.8 44.7
Property, plant and equipment 341.0 317.2
Investments in associates 3.5 3.5
Other assets 0.8 1.0
Other financial assets 0.9 0.8
Deferred tax assets 13.7 8.7
Total non-current assets 402.7 375.9
Current assets
Inventories 208.3 218.7
Trade receivables 168.3 173.9
Current income tax assets 5.0 5.8
Other assets 13.0 13.8
Other financial assets 50.5 120.8
Cash and cash equivalents 120.5 53.8
Total current assets 565.6 586.8
Total assets 968.3 962.7
EQUITY AND LIABILITIES
Equity
Subscribed capital 39.6 39.6
Share premium 219.8 219.8
Retained earnings 148.7 235.3
Share of profit or loss attributable to equity holders of the parent 1.8 -82.5
Equity attributable to equity holders of the parent 409.9 412.2
Non-controlling interests 0.2 0.1
Total equity 410.1 412.3
Liabilities
Provision for pensions and similar obligations 72.9 72.6
Other provisions 6.7 6.6
Financial liabilities 339.5 335.5
Other liabilities 2.1 2.2
Deferred tax liabilities 11.8 7.7
Total non-current liabilities 433.0 424.6
Other provisions 24.6 27.5
Current income tax liabilities 4.2 4.3
Financial liabilities 9.7 9.1
Trade payables 51.8 53.1
Other liabilities 34.9 31.8
Total current liabilities 125.2 125.8
Total liabilities 558.2 550.4
Total equity and liabilities 968.3 962.7

NET DEBT

in € million 31 March 2016 31 December 2015
Financial liabilities to financial institutions 345.5 340.8
Liabilities from finance leases 3.7 3.8
Financial liabilities 349.2 344.6
Cash and cash equivalents 120.5 53.8
Financial investments in other current financial assets* 50.0 119.9
Liquid assets and financial assets as part of the short-term financial disposition 170.5 173.7
Net debt 178.7 170.9

* Current financial investments of surplus cash and cash equivalents are included in other current financial assets.

SCHEDULE OF ASSETS – NET PRESENTATION

in € million Carrying amount
as of
1 January 2016
Capital
expenditure
Net disposals Depreciation and
amortisation
Currency
translation
differences
Carrying amount
as of
31 March 2016
Intangible assets 44.7 0.2 -0.1 -0.4 -1.6 42.8
Property, plant & equipment 317.2 32.1 -0.8 -5.3 -2.2 341.0
Total 361.9 32.3 -0.9 -5.7 -3.8 383.8

Dreieich, 12 May 2016 Biotest Aktiengesellschaft Board of Management

Dr Bernhard Ehmer Chairman of the Board of Management

Dr Michael Ramroth Member of the Board of Management

Dr Georg Floß Member of the Board of Management

ACKNOWLEDGEMENTS

PUBLISHER: Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.de IR CONTACT: Dr Monika Buttkereit, phone +49-6103-801-4406, [email protected] PR CONTACT: Dirk Neumüller, phone +49-6103-801-269, [email protected] DESIGN: Scheufele Hesse Eigler, Kommunikationsagentur GmbH, Frankfurt am Main, Germany EDITORIAL OFFICE: cometis AG, Wiesbaden, Germany

BIOTEST AG | Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.de

This quarterly statement contains forward-looking statements on the state of business, results of operations, cash flow and financial position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid atthe time of publication ofthis quarterly statement. Biotest does notintend to update the forward-looking statements and assumes no obligation to do so.