BIOHIT GROUP INTERIM REPORT Q3/2015

Transcription

1 Biohit Oyj Interim Report Q3 / 2015

2 BIOHIT GROUP INTERIM REPORT Q3/2015 Biohit Oyj Interim Report, 22 October 2015 at 9:30 am local time (EEST) SUMMARY January September / 2015 Net sales grew by 50.4% compared with January-September 2014 Net sales EUR 4.8 million (EUR 3.2 million) Operating result, continuing operations EUR -1.5* million (EUR -3.3 million) Result for the reporting period, continuing operations EUR -1.5 million (EUR -3.2 million) Result for the reporting period, discontinued operations EUR 0.0 million (EUR 3.3 million) Total result for the reporting period EUR -1.5 million (EUR 0.0 million) Net sales from international operations 88.1% (91.0%) of total net sales Equity ratio 88.0% (89.2%) July September / Q Net sales grew by 12.3% compared with Q3/2014 Net sales EUR 1.3 million (EUR 1.2 million) Operating result, continuing operations EUR -0.0* million (EUR -0.9 million) Result for the reporting period, continuing operations EUR -0.1 million (EUR -0.9 million) Result for the reporting period, discontinued operations EUR 0.0 million (EUR 0.0 million) Total result for the reporting period EUR -0.1 million (EUR -0.9 million) Net sales from international operations 87.8% (92.7%) of total net sales Equity ratio 88.0% (89.2%) * Includes a nonrecurring operating income of EUR 0.7 million from the consolidation of the joint venture. Net sales grew 12.3 % compared with Q3/2014 Equity ratio 88.0 % Net sales from international operations 87.8 % 2

3 PRESIDENT & CEO SEMI KORPELA: During the reporting period, the development of Biohit Oyj s net sales slowed down but however improved compared to January-September The focus of our business development during the third quarter of 2015 was on increasing services sales, expanding the international distributor network and supporting existing partners, for example by launching new products. Additionally and as planned we have continued our work in order to improve advancements in medical practices (incl. cancer screenings) and also to increase public awareness of acetaldehyde. In July, we announced that China started two gastric cancer screening studies using Biohit Oyj s GastroPanel test. The first study of early gastric cancer screening in the National Clinical Research Center for Digestive Diseases (Changhai Hospital), is funded by the Ministry of Science and Technology, which is the organizer of a multi-center study of early gastric cancer risk screening. The study will involve at least 20,000 persons in approximately 50 hospitals. The second study is being conducted in Chinese healthcare centers by the China Health Promotion Foundation. The foundation is a public organisation, managed by the Chinese Ministry of Health. Around half a million year-old asymptomatic persons will be tested in the study. The sample collection has begun in the summer of During the reporting period, in July, the registration of Acetium capsules in China was completed where our partner GrandPharma will begin the sales of Acetium capsules using the Chinese brand name Shubang by the end of the year. We also signed a distributor agreement with Portuguese ARIUM Sistemas de Diagnòstico Lda and it covers the distribution of diagnostic products in Portugal. In July we signed a distributor agreement with Korean Humas covering the distribution of Biohit quick tests. During the reporting period Helicobacter Pylori Quick Tests was registered in Singapore, Helicobacter Pylori UFT300 Quick Test and Helicobacter pylori IgG antibody for ELISA test was registered in Taiwan and many of our Quick Test were registered in Ukraine. In August we signed a distribution agreement with Kuwaiti Health Life covering Biohit Quick Tests. 3

4 In September Acetium product family grew with a new lozenge flavor. The salty liquorice flavored lozenges came into Finnish pharmacies during September-October. In the service sales side, we expanded our product portfolio with a blood sample based vitamin D test and developed our business by introducing an electronic appointment booking service in Finland. In September Biohit Oyj and Daiichi Sankyo (Thailand) Ltd signed a distributor agreement. With the agreement Daiichi Sankyo (Thailand) Ltd gains exclusive rights for the distribution of Acetium capsules in Vietnam, Laos, Cambodia and Myanmar. In September we extended the distribution agreement of Acetium products with Oriola Oy to the Baltic countries. In the Congress of the European Society for Biomedical Research on Alcoholism (ESBRA) held in September, a new study was introduced that assesses the effect of Acetium lozenges on salivary acetaldehyde concentrations after sipping of alcoholic beverages containing high levels of acetaldehyde. Promising results were gained with Acetium lozenge in the elimination of carcinogenic acetaldehyde in saliva. The motion of the European Parliament s committee on Environment, Public Health and Food Safety (ENVI) was accepted in May 2015, containing key elements regarding acetaldehyde. European Parliament urged the Commission to immediately ask the European Food Safety Authority (EFSA) to re-evaluate the use of acetaldehyde as a flavouring substance in alcoholic and non-alcoholic beverages. MEPs Against Cancer, an informal group of Members of the European Parliament, which is committed to actions against cancer held an expert consultation about alcohol and cancer on Wednesday September 16, Experts were present from European cancer organizations umbrella organization European Cancer League and from European Alcohol Policy Alliance Care that coordinates alcohol policy in the member states of the European Union. Our work to increase public awareness of acetaldehyde continues. We achieved a significant milestone in R&D operations during the reporting period when the development of the standardized GastroPanel test was completed. GastroPanel can now be carried out more cost effectively and user-friendly in the primary health care and screening processes. 4

5 CONSOLIDATED KEY FIGURES 7-9/ / / /2014 Net sales (MEUR) Operating profit/loss, continuing operations (MEUR) Profit/loss before taxes (MEUR) Profit/loss for the period, continuing operations (MEUR) Profit/loss for the period, discontinued operations (MEUR) Profit/loss for the period, total (MEUR) Average number of personnel Number of personnel at the end of the period Equity ratio (%) 88.0% 89.2% 88.0% 89.2% Earnings per share, continuing operations (EUR) Earnings per share, discontinued operations diluted (EUR) Shareholders' equity per share (EUR) Average number of shares during the period 14,346,537 14,010,050 14,074,818 13,893,963 Number of shares at the end of the period 14,348,533 14,030,593 14,348,533 14,030,593 REPORTING Biohit's product portfolio consists of diagnostic tests, acetaldehyde-binding products and monoclonal antibodies. The entire product portfolio is reported under a single segment. NET SALES AND RESULT January September Net sales grew by 50.4% compared with 1-9/2014. Shipments for screening studies in China had a positive impact on net sales in the reporting. The operating loss from continuing operations was EUR -1.5 million (EUR -3.3 million 1-9/2014). The result for continuing operations during the reporting period totalled EUR -1.5 million (EUR -3.2 million). The consolidation of the joint venture had a nonrecurring effect of EUR 0.7 million on the operating income. The result for discontinued operations during the reporting period totalled EUR 0.0 million (EUR 3.3 million). In conjunction with the divestment of the liquid handling business in late 2011, EUR 3.5 million of the gains 5

6 on the sale were not recognized due to the terms of the sale agreement and to other, related factors that remained open at the time. The amount was recognised on 31 March 2014, when the deal was closed. The result for the reporting period totalled EUR -1.5 million (EUR 0.0 million). Consolidated net sales and result for continued operations 7-9/ / 2014 Change 1-9/ / 2014 Change 1-12/ 2014 Net sales MEUR Change compared with the previous year (%) 12.3% 50.4% Operating income MEUR Change compared with the previous year (%) 94.7% 54.6% Operating income (% of net sales) -4% -77 % -31% -103% -103% BALANCE SHEET On 30 September 2015, the balance sheet total was EUR 13.3 million (31 December 2014 EUR 14.5 million), and the equity ratio was 88.0% (31 December %). FINANCING Biohit Oyj enjoys a strong financial position, which allows determined investments in an international distributor network as well as the development and commercialization of new products. At the end of the reporting period, the company's financial assets totalled EUR 8.5 million (31 December 2014 EUR 10.4 million). 6

7 RESEARCH AND DEVELOPMENT R&D operations were again focused on innovations, as well as product development and improved usability. Biohit Oyj also employs external experts and subcontractors in its R&D operations. Development expenditure has not been capitalized. Research and development expenditure during the 1 9/2015 reporting period amounted to EUR 1.6 million (EUR 1.5 million). In Finland, the clinical stage of ongoing research project on smoking cessation (with the Acetium lozenge as the research product) will be completed at the end of October. After this the examination of the results can begin. Two research projects on preventing migraine-type headache episodes (with the Acetium capsule as the research product) continue as planned. The development of the new standardized GastroPanel test is completed, and also the results of the first new clinical confirmatory examination of 100 patients are very good. A broader research of over 1000 patients at the Oulu University Hospital (Gastro Center) has received the approval of the Ethical Committee and is set to begin during October. Acetium capsules acetaldehyde-binding properties have been studied in a trial conducted in Sweden, which confirms the earlier scientific results related to Acetium. The studies showed that Acetium binds 60 80% of the group I carcinogenic acetaldehyde and creates a harmless MTCA compound. The report has been sent to be published in a high class scientific journal. Based on the results of a comparative ColonView trial published in the May issue of the international cancer journal, Anticancer Research, the ColonView test exceeds the performance of even the best currently available FIT clinical tests in terms of sensitivity as well as accuracy. A similar, comparative study has proceeded over midpoint at the Barretos cancer hospital in Brazil and preliminary results strengthen this view. GastroPanel testing targeted at the elderly population was carried out during the last reporting period to determine the prevalence of latent B12 vitamin deficiency and its causes (atrophic gastritis) among over 75- year-olds. The results show that the commonness of latent B12 vitamin deficiency among the elderly is at estimated level, but at the same time the results indicate that serious complications related to this deficiency could be prevented with early diagnostics and an appropriate substitution treatment. Ethical permission has now been gained for a similar study in Tartu. The results of the both studies will be reported together, when it can be determined whether or not there are observed population based differences in B12 vitamin levels and in complications arising from a lack of the vitamin. INVESTMENTS Gross investments during the reporting period 1-9/2015 totalled EUR 0.2 million (EUR 0.3 million), of which expenditure during the third quarter was EUR 0.0 million (EUR 0.1 million). 7

8 PERSONNEL During the reporting period 7-9/2015, the average number of personnel employed by the Group was 53 (52) of whom 45 (43) were employed by the parent company and 8 (9) by its subsidiaries. SHORT-TERM RISKS AND UNCERTAINTY FACTORS Biohit s key risks have to do with the investments required for business growth. There are risks involved in areas such as the success of clinical trials, new market areas, the selection and development of distribution channels, personnel recruitment, registration processes, product pricing, and political decision-making affecting the progress of screening programmes. Significant short-term risks are associated with the selection of new market areas, the timing of expansion into selected markets and product success in these markets. The recent increase in uncertainty factors associated with international politics may have an unfavourable impact on the company's business. The duration of the product registration process is different in each market area due to different processing times of local authorities. For this reason, it is not possible to accurately assess the time it takes to handle registrations in these areas and for product sales to begin. When investing liquid assets, the objective is to gain a return on investment with a minimum risk of equity loss. The investment portfolio consists of deposits, money market investments and corporate loans. A fundamental aspect of portfolio management is sufficient diversification across different asset classes, investment instruments and counterparties. Biohit conducts its investment activities with at least two partners. Thanks to its wide customer base, Biohit does not materially depend on any individual customers or project deliveries, with the exception of GastroPanel sales in China, which currently represents a major business for Biohit. Most of the company s business is conducted in euros. 8

9 MAIN EVENTS IN THE REPORTING PERIOD Gastric cancer screening study to start in China A gastric cancer risk screening study started in China, with at least people to be screened with the Biohit Oyj s GastroPanel test, with over 50 hospitals participating. The screenings are set to begin in 2015 and end in December Population-based screening study of asymptomatic persons to start in China, using GastroPanel biomarkers disclosing gastric cancer A gastric cancer risk screening study will be organised in Chinese healthcare centres by the China Health Promotion Foundation. The foundation is a public organisation managed by the Chinese Ministry of Health. The multi-centre study will be conducted by fifty to one hundred primary healthcare units. The screening of around half a million year-old asymptomatic persons will be tested with GastroPanel biomarkers, delivered by Biohit Oyj. Acetium family grew during September Acetium product family grew with a new lozenge flavor. A consumer survey chose salty liquorice as the Finns favorite flavor. In the future, the package color will indicate the flavor. The new flavor is in Finnish pharmacies during September. Biohit Oyj signed a distributor agreement with Daiichi Sankyo Biohit Oyj and Daiichi Sankyo (Thailand) Ltd signed a distributor agreement during the reporting period. The agreement was in force immediately, and Daiichi Sankyo (Thailand) Ltd gained exclusive rights for the distribution of Acetium capsules in Vietnam, Laos, Cambodia and Myanmar. Promising results with Acetium lozenge in the elimination of carcinogenic acetaldehyde in saliva A new study that assesses the effect of Acetium lozenges on salivary acetaldehyde concentrations after sipping of alcoholic beverages containing high levels of acetaldehyde, was introduced in the Congress of the European Society for Biomedical Research on Alcoholism (ESBRA). European parliament s expert consultation on acetaldehyde MEPs Against Cancer, an informal group of Members of the European Parliament, which is committed to actions against cancer held an expert consultation about alcohol and cancer on Wednesday September 16, 9

10 2015. Experts were present from European cancer organizations umbrella organization European Cancer League and from European Alcohol Policy Alliance Eurocare that coordinates alcohol policy in the member states of the European Union. Vitamin D test added to Biohit's Service Laboratory's selection in Finland Biohit Oyj launches a new test for diagnosis of vitamin D deficiency from venous blood samples. The concentration of 25-OH vitamin D in blood is so far the easiest and most reliable indicator of biologically active vitamin D levels. Serum 25-OH vitamin D levels reflect the total vitamin D storage of the body and also correlate with the clinical symptoms of vitamin D deficiency. MAJOR EVENTS AFTER THE END OF THE PERIOD Biohit Oyj launches a new version of the GastroPanel test The GastroPanel test unification project was completed after the reporting period. The result is a new Biohit GastroPanel test family, in which the four biomarkers (pepsinogen I and II, gastrin-17, Helicobacter pylori IgG antibody) will be processed using uniform reagents and reaction conditions. This increases the acceptance of the test and reduces significantly its labor-intensity and overall processing time. 10

11 SHARES AND SHAREHOLDERS Biohit Oyj s number of shares is 14,348,533 of which 2,975,500 (2,975,500) are Series A shares and 11,373,033 (11,340,093) are Series B shares. The Series B shares are quoted on NASDAQ Helsinki in the Small cap/healthcare group under the code BIOBV. Assuming that the market capitalisation for series A and B shares is equal, the total market capitalisation at the end of the period was EUR 71.2 million (EUR 81.3 million). The shares trade value during the period amounted to EUR 16.3 million. BIOBV/NASDAQ OMX Helsinki 1-9/ / /2014 High (EUR) Low (EUR) Average (EUR) Latest (EUR) Turnover (EUR) 16,303,870 22,531,644 25,927,811 Turnover volume 2,947,195 3,385,412 4,028,617 Shareholders At the end of the reporting period on 30 September 2015, the company had 6,764 shareholders (6,822 on 30 September 2014). Private households held 77.9% (78.0%), companies 20.2% (20.2%) and public sector organisations 0.0% (0.0%). Foreign ownership or nominee registrations accounted for 1.7% (1.7%) of shares. Further information on the shares, major shareholders and management shareholdings is available on the company's website at ACCOUNTING PRINCIPLES This interim report has been prepared in accordance with the requirements of the IAS 34 standard. All business operations are presented as one segment. Biohit Oyj has applied the same accounting principles in preparing this interim report as in its financial statements of The IFRS standards or standard interpretations that came into effect in 2015 did not have a material impact on the accounting principles. Joint control in accordance with the IFRS 10 standard fulfilled on part of Biohit Biotech (Hefei) Co. Ltd. by the closing date of 30 September 2015 in the way referred to in the standard and the shareholders agreement and the investment is therefore presented in the balance sheet drawn up according to the new standards and consolidated in Biohit s consolidated financial statements using the equity method. The consolidation had a nonrecurring effect of EUR 0.7 million on the operating income. In the future Biohit Oyj s share of the joint venture s profit/loss will be reported above operating profit. All of the figures in the interim report have been rounded up or down, due to which the sums of figures may deviate from the sum total presented. The figures for the reporting period are unaudited. 11

12 CONSOLIDATED INCOME STATEMENT EUR million 7-9/ 7-9/ 1-9/ 1-9/ 1-12/ Change Change Net sales Materials and services Gross margin Other operating income Sales and marketing Administration Production and product development Operating profit/loss, continuing operations Financial income Financial expenses Profit/loss before taxes Income taxes Income for the period, continuing operations Income for the period, discontinued operations Income for the period, total Available-for-sale financial assets Translation differences Other comprehensive income to be reclassified to profit or loss in subsequent periods Total comprehensive income for the period Earnings per share calculated from earnings attributable to equity holders of the parent company Undiluted earnings per share, continuing operations (EUR) Undiluted earnings per share, discontinued operations (EUR) Diluted earnings per share, discontinued operations (EUR) 1-9/ / /

13 CONSOLIDATED BALANCE SHEET MEUR 30 September September December 2014 ASSETS NON-CURRENT ASSETS Intangible assets Tangible assets Share in Joint Venture 0.7 Deferred tax assets Total non-current assets CURRENT ASSETS Inventories Trade and other receivables Other financial short-term assets Cash and cash equivalents Total current assets TOTAL ASSETS SHAREHOLDERS' EQUITY AND LIABILITIES Shareholders' equity attributable to the owners of the parent company Share capital Invested unrestricted equity fund Translation differences Retained earnings Total shareholders' equity NON-CURRENT LIABILITIES Deferred tax liabilities Other liabilities Total non-current liabilities CURRENT LIABILITIES Trade payables Total interest-bearing liabilities Tax liabilities Other liabilities Deferred gain Total current liabilities Total liabilities TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES

14 STATEMENT OF CHANGES IN EQUITY Consolidated statement of changes in equity on 30 September 2015 MEUR Share capital Translation differences Invested unrestricted equity fund Retained earnings Shareholders' equity Shareholders' equity 1 Jan Distribution of dividend Capital repayment Direct share issue Share based payments Exercise of share options Total comprehensive income for the period Shareholders' equity 30 Sep Consolidated statement of changes in equity on 30 September 2014 Share capital (MEUR) Translation differences (MEUR) Invested unrestricted equity fund (MEUR) Retained earnings (MEUR) Shareholders ' equity (MEUR) Shareholders' equity 1 Jan Distribution of dividend Capital repayment Direct share issue Share based payments Exercise of share options Total comprehensive income for the period Shareholders' equity 30 Sep

15 CASH FLOW STATEMENT MEUR 1-9/ / /2014 CASH FLOW FROM OPERATING ACTIVITIES Profit for the period Adjustments Change in working capital Interest paid and payments on other operating financial expenses Interest received Realised exchange rate gains and losses Income taxes paid Net cash flow from operating activities CASH FLOW FROM INVESTMENTS Investments in tangible and intangible assets Revenue from disposal of tangible and intangible assets Capital gain from the sale of liquid handling business Net investments in funds and deposits Net cash flow from investments CASH FLOW FROM FINANCING ACTIVITIES Rights issue Dividend payout Repayment of loans Net cash flow from financing activities Increase (+)/decrease (-) in cash and cash equivalents Cash and cash equivalents at the beginning of the period Effect of exchange rates on cash and cash equivalents Cash and cash equivalents at the end of the period RELATED PARTY TRANSACTIONS DURING JULY-SEPTEMBER 2015 Biohit Oyj B series shares subscribed with Stock Options I 2013 B A total number of 32,940 new Biohit Oyj B-shares have been subscribed for with stock options I 2013 B during July 7 th, These shares have been entered into the trade register on August 7 th, 2015, as of which date the new shares will establish equal shareholder rights with the company's existing B-shares. Public 15

16 trading is expected to begin on NASDAQ OMX Helsinki as of August 10, 2015 together with the existing B- shares. The share subscription price was EUR per share respectively. The entire subscription price of EUR 74, will be credited to the reserve for invested non-restricted equity, and the company share capital remains unchanged. The shares have no nominal value. After the subscription the number of all Biohit Oyj's shares will rise to 14,348,533 shares (14,315,593) and B- shares will rise to 11,373,033 shares (11,340,093). The new shares will correspond to a percentage of 0.23% of Biohit Oyj's total number of shares and 0.05% of the voting rights after registration. The share subscription period with stock options I 2013 B began on June 1, 2015 and will end May 31, 2019 and 32,940 of the available 40,000 shares were subscribed. The option schemes are based on the Biohit Oyj board resolution of June 19, 2013 and the Annual General Meeting authorization of April 14, The terms and conditions of the option schemes with additional information are available on Biohit Oyj website at COLLATERAL, CONTINGENT LIABILITIES, AND OTHER COMMITMENTS 30 September September December 2014 Collateral granted on behalf of the parent company Corporate mortgages Collateral granted on behalf of the subsidiaries Guarantees Other liabilities Leasing commitments Due for payment in less than one year Due for payment in more than one year but less than five years Due for payment in more than five years Total Other rental commitments Due for payment in less than one year Due for payment in more than one year but less than five years Due for payment in more than five years Total Other contingent liabilities Collateral and contingent liabilities total

17 NEXT FINANCIAL REPORT Biohit will publish its financial reporting time table later this year. Helsinki, 22 October 2015 Biohit Oyj Board of Directors Additional information: CEO Semi Korpela, Biohit Oyj tel investor.relations@biohit.fi Biohit in brief Biohit Oyj is a globally operating Finnish biotechnology company. Biohit s mission is Innovating for Health we produce innovative products and services to promote research and early diagnosis. Biohit is headquartered in Helsinki, Finland, and has subsidiaries in Italy and the UK. Biohit's Series B share (BIOBV) is quoted on Nasdaq Helsinki in the Small cap/healthcare group. 17