AI assistant
Biotest AG — Interim / Quarterly Report 2018
Nov 14, 2018
66_10-q_2018-11-14_5b6f17de-e258-4818-af17-6ccce853fed1.pdf
Interim / Quarterly Report
Open in viewerOpens in your device viewer
QUARTERLY STATEMENT 1 JANUARY TO 30 SEPTEMBER 2018
KEY FIGURES
| BIOTEST GROUP | Q1 – Q3 2018 | Q1–Q3 2017 | Change in% | |
|---|---|---|---|---|
| Revenue | € million | 289.6 | 263.0 | 10.1 |
| thereof: | ||||
| Germany | € million | 81.3 | 79.1 | 2.8 |
| Rest of world | € million | 208.3 | 183.9 | 13.3 |
| thereof: | ||||
| Therapy | € million | 252.8 | 218.0 | 16.0 |
| Plasma & Services | € million | 32.2 | 40.7 | –20.9 |
| Other Segments | € million | 4.6 | 4.3 | 7.0 |
| EBITDA | € million | 23.4 | –24.4 | >100 |
| Operating profit (EBIT) | € million | 5.1 | –33.9 | >100 |
| EBIT in% of revenue | % | 1.8 | –12.9 | |
| Earnings before taxes from continuing operations | € million | –11.8 | –52.1 | 77.4 |
| Earnings after taxes from continuing operations | € million | –6.6 | –41.0 | 83.9 |
| Earnings after taxes from discontinued operations | € million | 197.5 | 18.8 | >100 |
| Earnings after taxes (Total) | € million | 190.9 | –22.2 | >100 |
| Financing | ||||
| Cash flow from operating activities of continuing operations | € million | –61.5 | –20.7 | <–100 |
| Depreciation and amortisation | € million | 18.3 | 9.5 | 92.6 |
| 30 Sept. 2018 | 31 Dec. 2017 | |||
| Equity | € million | 505.3 | 347.8 | 44.9 |
| Equity ratio | % | 48.2 | 35.5 | |
| Employees (full-time equivalents) | Number | 1,630 | 1,659 | –1.7 |
KEY SHARE FIGURES
| Ordinary share | |
|---|---|
| Ticker / ISIN | BIO/DE0005227201 |
| Number of shares | 19,785,726 |
| Closing price* (28 September 2018) | € 23.45 |
| Highest/lowest price* 9M 2018 | € 31.40 / € 22.00 |
| Performance* 9 months | +3.7% |
| Performance* SDAX 9 months | –0.2% |
| Market capitalisation (28 September 2018) | € 464.0 million |
* Closing prices on Xetra trading system at Deutsche Börse AG
Following the reorganisation of the share indices by Deutsche Börse, Biotest has no longer been included in the SDAX since 24 September 2018.
Preference share
| Ticker / ISIN | BIO3/DE0005227235 |
|---|---|
| Number of shares | 19,785,726 |
| Closing price* (28 September 2018) | € 23.95 |
| Highest/lowest price* 9M 2018 | € 27.60 / € 18.68 |
| Performance* 9 months | +18.6% |
| Performance* SDAX 9 months | –0.2% |
| Market capitalisation (28 September 2018) | € 473.9 million |
The ordinary and preference shares of Biotest AG are listed in the Prime Standard segment of Deutsche Börse.
CONTENTS
- 3 Foreword
- 4 Business performance
- 6 Research and development
- 8 Marketing and distribution
- 8 Outlook, risk and opportunities report
- 8 Supplementary report
- 9 Consolidated statement of income
- 10 Consolidated statement of financial position
- 11 Consolidated cash flow statement
- 12 Acknowledgements
Ladies and Gentlemen,
In the third quarter of 2018 we successfully made structural changes in the Biotest Group. These were directly related to the acquisition by Creat. Following the approval of the American anti-trust authority FTC (Federal Trade Commission) in late July 2018, the sale of our US plasma collection companies to Grifols S.A. for USD 286 million was closed. With this process behind us, our focus now lies on realising the opportunities for Biotest as part of the Creat Group. We are identifying potential to work together more efficiently and act more effectively in the market.
If we look at the first nine months of 2018, we see a positive development compared with the same period of the previous year, with sales rising to € 289.6 million and EBIT improving to € 5.1 million.
Biotest also made encouraging progress in opening up new markets for our products. The European mutual recognition procedure for the product Cytotect® CP Biotest was successfully completed in the third quarter of 2018. This led to the product's approval in four other attractive European markets. Cytotect® CP Biotest is now approved in 12 EU markets.
Our expansion project Biotest Next Level remains of particular importance for the further growth of Biotest. We continued our progress in this area as planned. That included integrating an innovative, technologically leading system for virus inactivation into the production process. The system has enabled product safety in our production process to reach an even higher level.
In the first nine months of the year, we achieved important milestones for the further development of the Biotest Group. We will continue to pursue the path we have taken and cordially invite you to join us on this journey!
Kind regards,
Dr Bernhard Ehmer Chairman of the Board of Management
BUSINESS PERFORMANCE
A. AT A GLANCE
Unless otherwise stated, the following figures relate exclusively to continuing operations. The previous year's figures have been adjusted accordingly.
In the first nine months of 2018, the Biotest Group reported revenue of € 289.6 million. This is an increase of 10.1% over the € 263.0 million in sales during the same period of the previous year. Thus, we were able to compensate for last year's decline in sales, which was caused by the product recall of human albumin and its limited availability as well as the postponement of tender deliveries.
EBIT at Group level reached a positive level in the first nine months of the 2018 financial year, amounting to € 5.1 million (same period of the previous year: € –33.9 million).
During the first nine months of 2018 Biotest further expanded its network of the Group's own plasma collection centres in Europe. In this time, Biotest opened two plasma collection centres in the Czech Republic. There are now 19 collection centres in Europe to ensure the long-term supply of plasma.
The important expansion project Biotest Next Level was further advanced in the first nine months of 2018. Contamination in the ultra-pure media systems discovered during commissioning was removed using intensive cleaning activities. Commissioning of the systems which had been interrupted was resumed in the second quarter and the first process system for purification of IgG Next Generation was successfully qualified in June 2018 and transferred to Biotest.
Upon closing of the public takeover bid for Biotest AG shares announced on 18 May 2017, Tiancheng (Germany) Pharmaceutical Holdings AG, Munich, Germany (Tiancheng) – a company indirectly controlled by Creat Group Co. Ltd., Nanchang, People's Republic of China (Creat) – holds a majority stake (approximately 90% of the ordinary shares with voting rights of Biotest AG) in Biotest AG since 31 January 2018. A change of control under company law thus occurred on 31 January 2018 for Biotest AG and indirectly for Biotest Pharma GmbH.
In the context of the foreign trade approval from American authority CFIUS (Committee on Foreign Investment in the United States) for the takeover, Biotest signed an agreement on the sale of its US companies Biotest Pharmaceuticals Corporation, Boca Raton, USA, (BPC) and Biotest US Corporation, Boca Raton, USA. Until the closing of this sale, Biotest AG had transferred the US companies to a US trustee on 19 January 2018. As a result of the transfer to the US trustee, the conditions for including the US companies in the consolidated financial statements were no longer met, and consequently, the US companies were removed from the scope of consolidation at Biotest. The business attributable to these companies was assigned to "discontinued operations."
With the approval of the American anti-trust authority FTC (Federal Trade Commission) on 31 July 2018, it was possible to close the sale of the US companies to Grifols Shared Services North America, Inc., a subsidiary of Grifols S.A., Barcelona, Spain, for USD 286 million. The recognised gain on disposal amounts to € 162.4 million.
The US authority CFIUS had already approved the sale of US companies Biotest Pharmaceuticals Corporation, Boca Raton, USA, and Biotest US Corporation, Boca Raton, USA, in late April 2018.
In connection with the sale of the US business, BPC and its former parent company, Biotest AG, signed a Share Transfer, Amendment and Release Agreement with ADMA Biologics, Inc. (ADMA) on 14 May 2018. Thereafter, BPC transferred all non-voting common stock in ADMA to ADMA. In return, ADMA waived, among other things, BPC's rights to repurchase two ADMA plasma collection centres from BPC as well as potential indemnification claims against BPC and Biotest connected to the original master purchase agreement.
On 8 February 2018, Tiancheng informed Biotest AG that it intends to persue into a domination and profit and loss transfer agreement pursuant to Section 291 para. 1 of the German Stock Corporation Act (AktG) with Biotest AG as the dominated and profit transferring company and Tiancheng as dominating company, which is authorised to receive the profit transfer, and to vote in favour of such domination and profit and loss transfer agreement in a general shareholders meeting of Biotest AG. The evaluation of this initiative by Tiancheng is still ongoing.
In the first quarter of 2018, Creat notified Biotest that it was considering integrating Tiancheng International Investment Limited, Hong Kong – the indirect majority shareholder in Biotest AG's voting capital – into Shanghai RAAS Blood Products Co., Ltd., Shanghai, People's Republic of China, as part of a capital increase. The respective preparations are currently underway.
To lenders who exercised their special termination rights after 20 July 2018 as well as to lenders who did not accept the agreement on the deferral of rights as a result of the change of control on 29 August 2017 (the "Umbrella Agreement"), promissory notes of € 154.0 million and USD 36.5 million and a KfW loan of € 169.8 million were repaid until the publication of the report. Contracts regarding short-term credit lines in the amount of € 97.5 million were cancelled by mutual agreement or were not extended. Prepayment penalties in connection with this change of the financing structure amounted to approximately € 8.5 million. Promissory note loans of € 10.5 million and USD 13.5 million were repaid on maturity on 30 October 2018.
Tiancheng (Germany) Pharmaceutical Holdings AG concluded a contract with Biotest on 28 August 2017 to grant a subordinated shareholder loan of € 190.0 million with a term of 2 years from the date of drawing in oder to to replace loans that would be claimed back on the basis of special termination rights. The loan was granted to Biotest AG on 30 January 2018. A further subordinated shareholder loan in the amount of € 150.0 million was granted on 8 June 2018. This increased the amount of loans provided by the shareholder to a total of € 340 million. The loan has a term until 30 April 2020 and served to repay loans to lenders exercising their special right of termination after 20 July 2018. After receipt of the proceeds from the sale of the US business, part of the second shareholder loan in the amount of € 50.0 million was repaid as agreed in the loan agreement.
For interim financing until the proceeds from the sale of the US companies were received, Biotest AG had taken out a loan of € 160.0 million on 18 July 2018 which was fully repaid on 1 August 2018. Until this sale was closed, Biotest AG had transferred the US companies to a US trustee. As part of the sale, various assets will remain with the US trustee which have meanwhile been transferred to Biotest or will be sold by the US trustee.
A significant factor influencing the calculation of pension obligations for employees in Germany is mortality probabilities, which are determined using Heubeck mortality tables in version 2005G. On 20 July 2018, Heubeck AG published new mortality tables containing new mortality probabilities. The new mortality tables will be applied as of 31 December 2018. Biotest assumes that this will not lead to a significant increase in the pension obligation, which would be reflected in a change in equity not affecting net income.
On 10 August 2018, the Biotest AG Supervisory Board again extended the Board of Management employment contract for Dr Ehmer to April 2019.
Result of operations
In the first nine months of 2018, the Biotest Group generated revenue of € 289.6 million, after € 263.0 million in the same period of the previous year. Previous-year revenue was negatively impacted by credit notes for the recall of human albumin, particularly in the core segment Therapy. As a result, revenue in this segment increased 16.0% to € 252.8 million, after € 218.0 million in the previous year. The revenue decrease in the Plasma & Services segment is due primarily to the general economic situation in the Middle East and to the discontinuation of a toll manufacturing contract with a long-term customer.
SALES BY SEGMENT
| in € millions | Q1 – Q3 2018 | Q1–Q3 2017 | Change in% |
|---|---|---|---|
| Therapy | 252.8 | 218.0 | 16.0 |
| Plasma & Services | 32.2 | 40.7 | –20.9 |
| Other Segments | 4.6 | 4.3 | 7.0 |
| Biotest Group | 289.6 | 263.0 | 10.1 |
In addition to the segments, which present both the type of sales and the underlying contract types, sales are also broken down geographically. Since the current 2018 financial year, Biotest has been reporting in four sales regions worldwide instead of the previous six regions. A map indicating what countries comprise the "Central Europe," "Eastern and Southern Europe," "Intercontinental" and "Middle East, Africa and France" sales regions can be found at the end of this quarterly report.
In the first nine months of 2018, Biotest generated sales growth in all four regions. With sales of € 110.3 million, the Central Europe region made the largest contribution to sales.
SALES BY REGION
| Biotest Group | 289.6 | 263.0 | 10.1 |
|---|---|---|---|
| Middle East, Africa and France |
76.0 | 64.6 | 17.6 |
| Intercontinental | 53.3 | 48.0 | 11.0 |
| Eastern and Southern Europe |
50.0 | 45.6 | 9.6 |
| Central Europe | 110.3 | 104.8 | 5.2 |
| in € million | Q1 – Q3 2018 | Q1–Q3 2017 | Change in% |
EBIT of continuing operations was € 5.1 million in the first nine months of 2018 (same period of the previous year: € –33.9 million). It includes expenses for the Biotest Next Level project of € 37.8 million (same period of the previous year: € 40.9 million). EBIT for the previous year was also negatively impacted by the human albumin recall. For the first nine months of the current financial year, the EBIT margin was 1.8% after –12.9% in the same period of the previous year. In the core segment Therapy EBIT was positive at € 8.2 million in the first nine months of the 2018 financial year (same period of the previous year: € –27.2 million, considerably impacted by the negative effect of the human albumin recall).
EBIT BY SEGMENT
| in € million | Q1 – Q3 2018 | Q1–Q3 2017 | Change in% |
|---|---|---|---|
| Therapy | 8.2 | –27.2 | >100 |
| Plasma & Services | 0.2 | 2.2 | –90.9 |
| Other Segments | –3.3 | –8.9 | 63.3 |
| Biotest Group | 5.1 | –33.9 | >100 |
EBIT of discontinued operations amounted to € 196.5 million in the reporting period after € 18.6 million in the same period of the previous year. It was positively influenced with the recognition of the disposal gains of € 162.4 million and from foreign currency translation differences, which were previously recognised directly in equity under other comprehensive income and reclassified to profit and loss in connection with the deconsolidation of the US companies.
Earnings after taxes of continuing operations were € –6.6 million (same period of the previous year: € –41.0 million).
Earnings after taxes of discontinued operations amounted to € 197.5 million in the first nine months of 2018 after € 18.8 million in the same period of the previous year.
For the first three quarters of 2018, Biotest Group's total earnings after taxes (EAT) were € 190.9 million (same period of the previous year: € –22.2 million). This results in earnings per share of € 4.81 after € –0.57 in the same period of the previous year.
Financial position
The Biotest Group's total assets increased from € 978.5 million as of 31 December 2017 to € 1,047.5 million as of 30 September 2018. This increase was significantly influenced by continued investments at the Dreieich site as part of our Biotest Next Level expansion project and the completion of the sale of the US companies, which is reflected in the increase in cash and cash equivalents.
Under equity and liabilities, equity increased to € 505.3 million as of 30 September 2018 due to the high profit for the period (31 December 2017: € 347.8 million). As a result, the equity ratio reached 48.2%. Debt decreased to € 542.2 million (31 December 2017: € 630.7 million). This was primarily due to the repayment of current financial liabilities.
Cash Flow
The Biotest Group reported negative operating cash flow for continuing operations of € –61.5 million in the first nine months of 2018 resulting from changes in working capital. This was due in particular to payments for trade payables in the amount of € 26.6 million. This effect is caused in particular by the completion of the construction phase of the Biotest Next Level project. In addition, the increase in receivables of € 17.3 million and inventories of € 32.8 million due to reference date factors also contributed to the strong change in working capital. In the same period of the previous year, operating cash flow amounted to € –20.7 million. Cash flow from investing activities for continuing operations amounted to € –35.5 million in the period from January to September 2018 (same period of the previous year: € –79.2 million). The high positive cash flow from investing activities from discontinued operations of € 256.3 million resulted from the purchase price payment for the US plasma companies. Cash flow from financing activities for continuing operations was € –61.0 million in the first nine months of 2018 (same period of the previous year: € 39.3 million), primarily due to repayment of financial loans.
B. RESEARCH AND DEVELOPMENT
The costs of research and development decreased by 13.3% to € 36.2 million in the first nine months of the business year 2018 (same period of the previous year: € 41.8 million). A complete list of all research and development projects is provided in the 2017 Annual Report (pages 18 to 21). Biotest was able to make further progress with the following research and development projects in the period from January to September 2018:
RESEARCH & DEVELOPMENT PROGRESS IN THE FIRST NINE MONTHS OF 2018
Therapeutic area Haematology
Indatuximab ravtansine (BT-062)
For the phase I/IIa clinical trial (no. 989) on triple-receptor negative metastatic breast cancer and metastatic bladder cancer, the patient follow up was completed in 2017 and the trial was analysed. The clinical trial confirms the good safety profile of BT-062 and presents initial encouraging indications of efficacy in these severely ill patients for whom the options for further treatment of their cancer have largely been exhausted. Publication of the data is being prepared.
When combined with chemotherapy, BT-062 also shows synergetic efficacy in a tumour mouse model for triplenegative breast cancer that is particularly difficult to treat.
Clinical data on combined treatment using BT-062 and Lenalidomide or Pomalidomide and Dexamethasone in multiple myeloma (phase I/IIa clinical trial no. 983) from a period of nearly six years is now available. It shows that BT-062 treatment in these patient groups combined with Lenalidomide or Pomalidomide and Dexamethasone results in a good response rate to the treatment. Treatment of these patients was completed in September 2018.
Therapeutic area Clinical Immunology
IgG Next Generation The immunoglobulin G product IgG Next Generation is being developed to treat primary immune deficiencies, secondary antibody deficiency syndromes and several autoimmune diseases. In the previous year, a new production process was developed for this project with significantly higher yields and further improved product properties. In the long term, IgG Next Generation will replace the existing product Intratect® as a global product and will be the "master product" for the new Biotest Next Level manufacturing facility. Two pivotal studies of IgG Next Generation are currently underway in several European countries and in the US: Firstly, a phase III clinical trial (no. 991) on the treatment of patients with primary immune deficiencies (PID) and, secondly, a phase III clinical trial (no. 992) on the treatment of immune thrombocytopenia (ITP). In clinical trial no. 991, the recruitment of adults has already been completed, while children are still being included in the study. The European Medicines Agency (EMA) agreed with the positive recommendation of the Paediatric Committee (PDCO) regarding the paediatric development plan (PIP) for the indications PID and ITP. The U.S. Food and Drug Administration (FDA) has approved the submitted Pediatric Study Plan (PSP) for the indication PID as well. The need to conduct a special children's study can be avoided by including more children in the PID Study no. 991. In Study no. 992, patient recruitment continues as planned. Patient recruitment is close to being completed. Preparations are now underway to transfer the IgG process from the pilot plant (Technical centre) to the new Biotest Next Level facility. BT-063 In the ongoing phase IIa clinical trial (no. 990), the safe-
ty and tolerability of the monoclonal antibody BT-063 are studied in the lead indication of systemic lupus erythematosus (SLE), and initial data was collected on efficacy. The phase IIa clinical trial (no. 990) is currently being analysed. The study report is now being written and publication of the data is being prepared.
| Cytotect® | Cytomegalovirus (CMV) infection is quite common in patients following a haematopoietic (blood-forming) stem cell transplantation (HSCT) complication that leads to a substantial number of infections and cases of death. Some 40,000 HSCTs are performed in Europe each year, in most cases to treat certain types of blood cancer, such as myeloma or leukaemia. A recently published retrospective data collection from France highlights the benefits of Cytotect® in treating CMV in HSCT patients. High-risk patients were treated with Cytotect® after antiviral drugs failed. The published overall response rate in patients was 78%. In particu lar, CMV infection was eliminated in the blood in 70% of all cases, which is an excellent result given the prior failure of alternative treatment approaches in these patients. |
|---|---|
| ----------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Trimodulin (IgM Concentrate) Preparations are currently underway to start the phase III clinical trial with Trimodulin (IgM Concentrate). The clinical trial design has already been approved by the relevant authorities (EMA, FDA, Paul-Ehrlich-Institut). Fibrinogen In March 2018, the first patient with acquired fibrinogen deficiency was treated in the phase III clinical trial
Therapeutic area Intensive Care Medicine
- "ADFirst" (no. 995). The ongoing phase I/III clinical trial (no. 984) in the treatment of patients with congenital fibrinogen deficiency is proceeding as planned. Congenital indication (Study no. 984): The EMA approved the paediatric development plan to treat children under 6 years of age in this study and the first children have already been included.
- Pentaglobin In the first quarter of 2018, the first patient was added to the PERFORM registry (Pentaglobin® Registry For Outcome Report and Monitoring) – a non-interventional study to assess the efficacy and safety of Pentaglobin® in adult patients with life-threatening severe bacterial infections or sepsis. Biotest supports the PER-FORM registry, which was initiated by the Center for Clinical Studies at Jena University Hospital, Germany. A recently published study by Medizinische Hochschule Hannover (Hanover Medical School, Germany) showed that the rate of survival in patients with early development of donor-specific antibodies (DSA) after lung transplantation was significantly increased by administering Pentaglobin® (IgM-enriched immunoglobulin). In lung transplantation, the development of DSA significantly increases the mortality risk and the risk of organ rejection. Between 20 and 30% of all patients with lung transplantations develop DSA. So far, there is no established treatment in lung transplantations. In the Pentaglobin® group (128 patients), the 94% rate of survival after one year was comparable to that of patients without development of DSA (452 patients) and significantly higher than the 79% rate of survival in the historical comparison group (57 patients with development of DSA), who were treated with therapeutic plasma exchange. The relative reduction of the mortality rate after one year was over 70%.
C. MARKETING AND DISTRIBUTION
MARKETING & DISTRIBUTION PROGRESS IN THE FIRST NINE MONTHS OF 2018
| Therapeutic area Clinical Immunology | |
|---|---|
| Fovepta® | Marketing authorisations for Jordan was granted in May 2018. Fovepta® received final marketing authorisation by the Gulf Central Committee for Drug Registration in June 2018. In addition, initial sales were generated in Lebanon via a new distributor. |
| Hepatect® | Marketing authorisations for Jordan was granted in May 2018. |
| Cytotect® | The MRP (Mutual Recognition Procedure) to extend the approvals of Cytotect® in the EU countries Spain, Croa tia, Slovenia and Poland has been completed. National approvals are expected shortly. |
| Intratect | Marketing authorisation for Intratect 5% 50 ml was granted in Turkey. Marketing authorisation for Intratect 5% was granted in Palestine and Costa Rica. New Marketing authorisation for Intratect 10% was granted in the United Arab Emirates. |
| Therapeutic area Haematology | |
| Haemoctin® | Marketing authorisation was granted in Morocco and Palestine. Marketing authorisation was granted for 250IU and 1000IU in Iran. |
| Therapeutic area Intensive Care Medicine | |
| Albiomin® | New Marketing authorisation was granted in Palestine. |
D. OUTLOOK, RISK AND OPPORTUNITY REPORT
I. CHANGE IN OUTLOOK REPORT
The Biotest Group's outlook has not changed significantly from its presentation in the 2017 Annual Report (page 28).
Pentaglobin® New Marketing authorisation was granted in Azerbaijan.
II. RISK REPORT
The risk situation of the Biotest Group has changed in terms of the following factors since its presentation in the 2017 Annual Report (pages 30 to 39):
All the banks and promissory note creditors who wanted their loans repaid due to the change of control executed on 31 January 2018 under company law at Biotest AG were repaid due to the shareholder loan granted by Tiancheng (Germany) Pharmaceutical Holdings AG and as a result of the sale of the US business. The largest single lender is now Tiancheng (Germany) Pharmaceutical Holdings AG.
Tiancheng (Germany) Pharmaceutical Holdings AG concluded a contract with Biotest on 28 August 2017 to grant a subordinated shareholder loan of € 190.0 million with a term of two years from the date of drawing in oder to to replace loans that would be claimed back on the basis of special termination rights. The loan was granted to Biotest AG on 30 January 2018. A further subordinated shareholder loan in the amount of € 150.0 million was granted on 8 June 2018. This increased the amount of loans provided by the shareholder to a total of € 340 million. The loan has a term until 30 April 2020 and served to repay loans to lenders who exercise their special right of termination after 20 July 2018. Part of the second shareholder loan in the amount of € 50.0 million was repaid after receipt of the proceeds from the sale of the US business as agreed in the loan agreement.
In May 2018, US President Donald Trump announced that the US would withdraw from the nuclear deal with Iran. He reintroduced the sanctions against the country. This could have a negative impact on the value of Biotest's assets in the mid doubledigit million range. The sanctions could also lead to a complete termination of business relations. The Board of Management currently assesses this risk as moderate, but does not rule out that the situation may deteriorate in the course of the year as a result of the US sanctions.
III. OPPORTUNITIES REPORT
The opportunity situation of the Biotest Group has not changed significantly compared to the presentation in the 2017 annual report (pages 39 and 40).
After approval from the British anti-trust authorities, talks have taken place between Biotest and Bio Products Laboratory Ltd., Elstree (London), UK, subsidiary of Tiancheng International, to assess options for enhanced cooperation and identify possible synergy effects.
E. SUPPLEMENTARY REPORT
After the balance sheet date, Plasma Service Europe GmbH, a 100% subsidiary of Biotest AG, has acquired a plasmapheresis centre in Hanover, Germany. The closing of the transaction is expected in the first quarter 2019.
CONSOLIDATED STATEMENT OF INCOME
of the Biotest Group for the period from 1 January to 30 September 2018
| in € million | Q3 2018 | Q3 2017 | Q1 – Q3 2018 | Q1–Q3 2017 |
|---|---|---|---|---|
| Revenue | 88.9 | 93.0 | 289.6 | 263.0 |
| Cost of sales | –55.1 | –60.0 | –191.9 | –184.4 |
| Gross profit | 33.8 | 33.0 | 97.7 | 78.6 |
| Other operating income | 3.9 | 1.1 | 7.0 | 2.3 |
| Marketing and distribution costs | –11.7 | –11.1 | –37.3 | –38.0 |
| Administrative expenses | –7.8 | –8.9 | –23.8 | –32.5 |
| Research and development costs | –13.4 | –15.2 | –36.2 | –41.8 |
| Other operating expenses | –0.6 | –0.6 | –2.6 | –2.5 |
| Change of write downs on financial assets recognised at amortised cost | 0.2 | – | 0.3 | – |
| Operating profit | 4.4 | –1.8 | 5.1 | –33.9 |
| Value adjustments on financial instruments recognised at fair value | –0.7 | – | –4.0 | – |
| Financial result | –5.5 | –10.0 | –12.9 | –18.2 |
| Earnings before taxes | –1.8 | –11.8 | –11.8 | –52.1 |
| Income taxes | 3.2 | 1.0 | 5.2 | 11.1 |
| Earnings after taxes from continuing operations | 1.3 | –10.8 | –6.6 | –41.0 |
| Earnings after taxes from discontinued operations | 3.8 | 6.4 | 197.5 | 18.8 |
| Earnings after taxes (Total) | 5.1 | –4.4 | 190.9 | –22.2 |
| Attributable to: | ||||
| Equity holders of the parent | 5.1 | –4.4 | 190.0 | –22.2 |
| thereof from continuing operations | 1.3 | –10.8 | –6.6 | –41.0 |
| thereof from discontinued operations | 3.8 | 6.4 | 197.5 | 18.8 |
| Non-controlling interests | ||||
| thereof from continuing operations | – | – | – | – |
| thereof from discontinued operations | – | – | – | – |
| Earnings per share in € | 0.13 | –0.12 | 4.81 | –0.57 |
| thereof from continuing operations | 0.03 | –0.28 | –0.18 | –1.05 |
| thereof from discontinued operations | 0.10 | 0.15 | 4.98 | 0.47 |
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
of the Biotest Group as of 30 September 2018
| in € million | 30 September 2018 | 31 December 2017 |
|---|---|---|
| ASSETS | ||
| Non-current assets | ||
| Intangible assets | 16.4 | 16.6 |
| Property, plant and equipment | 507.1 | 477.1 |
| Investments in joint ventures | 2.3 | 2.3 |
| Other assets | 0.2 | 0.3 |
| Other financial assets | 0.2 | 13.0 |
| Deferred tax assets | 21.0 | 19.5 |
| Total non-current assets | 547.2 | 528.8 |
| Current assets | ||
| Inventories | 179.6 | 146.9 |
| Trade receivables | 143.9 | 133.8 |
| Current income tax assets | 0.4 | 4.1 |
| Other assets | 14.0 | 10.5 |
| Other financial assets | 36.8 | 6.5 |
| Cash and cash equivalents | 119.6 | 22.3 |
| Assets from discontinued operations | 6.0 | 125.6 |
| Total current assets | 500.3 | 449.7 |
| Total assets | 1.047.5 | 978.5 |
| EQUITY AND LIABILITIES | ||
| Equity | ||
| Subscribed capital | 39.6 | 39.6 |
| Share premium | 219.8 | 219.8 |
| Retained earnings | 54.9 | 91.7 |
| Share of profit or loss attributable to equity holders of the parent | 190.8 | –3.5 |
| Equity attributable to equity holders of the parent | 505.1 | 347.6 |
| Non-controlling interests | 0.2 | 0.2 |
| Total equity | 505.3 | 347.8 |
| Non-current liabilities | ||
| Provisions for pensions and similar obligations | 87.8 | 86.3 |
| Other provisions | 1.7 | 2.5 |
| Financial liabilities | 318.8 | 286.8 |
| Other liabilities | 0.2 | 1.3 |
| Deferred tax liabilities | 2.6 | 2.6 |
| Total non-current liabilities | 411.1 | 379.5 |
| Current liabilities | ||
| Other provisions | 23.5 | 22.1 |
| Current income tax liabilities | 2.9 | 3.4 |
| Financial liabilities | 34.3 | 119.6 |
| Trade payables | 45.4 | 65.0 |
| Other liabilities | 25.0 | 27.0 |
| Liabilities of discontinued operations | 0.0 | 14.1 |
| Total current liabilities | 131.1 | 251.2 |
| Total liabilities | 542.2 | 630.7 |
| Total equity and liabilities | 1.047.5 | 978.5 |
CONSOLIDATED CASH FLOW STATEMENT
of the Biotest Group for the period from 1 January to 30 September 2018
| in € million | Q1 – Q3 2018 | Q1–Q3 2017 |
|---|---|---|
| Operating cash flow before changes in working capital | 27.7 | 7.8 |
| Cash flow from changes in working capital | –84.9 | –17.7 |
| Interest and taxes paid | –4.3 | –10.8 |
| Cash flow from operating activities from continuing operations | –61.5 | –20.7 |
| Cash flow from operating activities from discontinued operations | –0.5 | 9.4 |
| Cash flow from operating activities total | –62.0 | –11.3 |
| Cash flow from investing activities from continuing operations | –35.5 | –79.2 |
| Cash flow from investing activities from discontinued operations | 256.3 | –16.2 |
| Cash flow from investing activities total | 220.8 | –95.4 |
| Cash flow from financing activities from continuing operations | –61.0 | 39.3 |
| Cash flow from financing activities from discontinued operations | – | 14.4 |
| Cash flow from financing activities total | –61.0 | 53.7 |
| Cash changes in cash and cash equivalents | 97.8 | –53.0 |
| Exchange rate-related changes in cash and cash equivalents | –0.5 | –0.8 |
| Cash and cash equivalents on 1 January | 22.3 | 84.7 |
| Cash and cash equivalents on 30 September | 119.6 | 30.9 |
| thereof from discontinued operations | – | – |
| thereof from continuing operations | 119.6 | 30.9 |
THE FOUR SALES REGIONS OF BIOTEST
Intercontinental Middle East, Africa and France Eastern and Southern Europe Central Europe
SCHEDULE OF ASSETS – NET PRESENTATION
| in € million | Carrying amount as of 31 December 2017 |
Capital expenditure |
Disposals net | Depreciation and amortisation |
Currency translation differences |
Carrying amount as of 30 September2018 |
|---|---|---|---|---|---|---|
| Intangible assets | 16.6 | 1.0 | – | –1.2 | – | 16.4 |
| Property, plant & equipment | 477.1 | 48.2 | –0.6 | –17.1 | –0.5 | 507.1 |
| Total | 493.7 | 49.2 | –0.6 | –18.3 | –0.5 | 523.5 |
Dreieich, 14 November 2018 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
FINANCIAL CALENDAR
| 28 March 2019 | Annual Report 2018 Financial statements press conference 2018 |
14 August 2019 | Half-Year Report 2019 |
|---|---|---|---|
| 7 May 2019 | Quarterly Statement as of 31 March 2019 Annual General Meeting |
14 November 2019 | Quarterly Statement 9 months 2019 |
ACKNOWLEDGEMENTS
−
| PUBLISHER: | Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com |
|---|---|
| IR CONTACT: | Dr Monika Buttkereit, phone +49-6103-801-4406, Fax +49-6103-801-347, [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 | |
| PHOTOGRAPHY: | Simone Kiefer, Dreieich, Germany |
BIOTEST AG | Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
This report contains forward-looking statements on overall economic development as well as on the state of business, results of operation, cash flows 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 at the time of publication of this report. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.