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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.