Annual Report • Mar 29, 2019
Annual Report
Open in ViewerOpens in native device viewer
Review by the President & CEO Strategy and quality History Corporate governance Financial statements

Contents
Review by the
| Biohit in brief……………………………………………………………… | 1 |
|---|---|
| Year 2018 …………………………………………………………………… |
2 |
| Review by the President & CEO ………………………………… |
5 |
| Strategy……………………………………………………………………… | 7 |
| The Acetium® tablet for smoking cessation ……………… |
8 |
| History ……………………………………………………………………… |
9 |
| Corporate Governance Statement 2018 …………………… |
12 |
| Board of Directors …………………………………………………… |
21 |
| Management Team ………………………………………………… |
22 |
| Information for shareholders…………………………………… | 23 |
| Summary of stock exchange releases in 2018 ………… |
24 |
| Financial statements ……………………………………………… |
25 |
Biohit Oyj carries out research and development work to improve the quality of life of patients and prevent diseases

Review by the President & CEO Biohit in brief Strategy and quality History Corporate governance Financial statements
Biohit Oyj is a Finnish biotechnology company operating on global markets. Our mission, "Innovating for Health", describes our innovative products and services, which aim to promote medical research and early diagnosis, and prevent serious illnesses.
Our goal is to improve people's quality of life by preventing diseases, human suffering and financial loss. Biohit is headquartered in Helsinki and has subsidiaries located in Italy and the United Kingdom. Biohit's Series B shares (BIOBV) are listed in Nasdaq OMX Helsinki Small Cap group and in the healthcare sub-sector.
Gastrointestinal diseases are a growing world-wide concern, with related medical, ethical and financial problems. World-wide, gastrointestinal diseases are the most common cause for people to seek treatment or suffer problems due to a lack of treatment. As the population ages, the need for healthcare will increase further, leading to an urgent requirement for new, cost-effective solutions.
The numerous health-related problems caused by smoking are the most common preventable form of mortality in western countries. Biohit helps people
Biohit serves healthcare organisations and patients by promoting gastric and colorectal health. The most recent innovation is Acetium®, which promotes smoking cessation.
to give up smoking with a new method that does not cause nicotine addiction. The Acetium® lozenge is a natural preparation containing L-cysteine which has already helped numerous smokers to stop smoking altogether or significantly reduce their smoking.
Biohit continuously develops its products and services to address society's needs. Our products and services are researched, cost-effective innovations for diagnosing and preventing diseases and associated risks.
Year 2018
Review by the President & CEO Biohit in brief Strategy and quality History Corporate governance Financial statements
We launched the Acetium® lozenge in a wide range of distribution channels. We also increased product awareness in the healthcare industry overall.

In September 2018 we launched Acetium® lozenge in Finland. Acetium® lozenge is effective and safe product which helps smokers to quit smoking without consuming addictive nicotine or incurring any of the potential side-effects of medicinal intervention methods. The lozenge also contains a small amount of xylitol, which improves overall oral hygiene.
Usage of Acetium® lozenge is started just before smoking and is continued during the duration of smoking the cigarette. Acetium® lozenge effectively binds carcinogenic acetaldehyde that dissolves in saliva during smoking. Also mouth microbes produce acetaldehyde from alcohol, which is removed by Acetium® lozenge. The product launch is ongoing in several distribution channels in Finland and will continue during 2019.
During the review period Acetium® lozenge was granted patents until 12 September 2028 in all nine Eurasian countries including Russia and In 2018, we invested in various studies and a significant product launch, and we obtained new patents.
Belarus. Acetium® lozenge has also been granted a European patent: EP 2 197 436 B1, Sucking tablet for use in reducing tobacco and/or alcohol dependence. In addition, patent has been granted in all African countries and Mexico. There are also several pending patent applications in other countries.
The new GastroPanel® quick test, intended for point-of-care testing, is conducted using a fingertip blood sample during a primary care appointment. The GastroPanel® quick test will be available in Europe as soon as the performance and clinical testing required for the CE mark are completed. We expect to have CE mark available during H2/2019.
Review by the President & CEO Biohit in brief Strategy and quality History Corporate governance Financial statements
We consider GastroPanel's® market position in China to be strong, and demand is expected to increase in the forthcoming years.
During 2018 we got positive study results of colorectal cancer screening tests in Brazil. The clinical state of migraine study was concluded at the end of June, however the results are not completed until end of H1/2019.
In the future we are selective regarding our investments on clinical studies and we shift our focus on commercialization of our excellent products.
During the review period Biohit's distributor Biohit HealthCare (Hefei) Co. Ltd announced that it will make significant investment to expand its production capacity. According the latest estimate new capacity will be available until end of Q1/2020. Biohit Healthcare (Hefei) Co. Ltd acquired from Biohit's main shareholder Osmo Suovaniemi and from his family 33.2% of total number of Biohit shares and 29.5% of the voting rights based on shares.
GastroPanel® market situation in China is strong and we expect the demand to grow in the coming years.

EUR 9.9 million NET SALES
INCREASE IN NET SALES (%) EUR
10.6%
–0.1million OPERATIVE EBITDA
| Biohit Group's key figures | 2018 | 2017 |
|---|---|---|
| Net sales (EUR million) | 9.9 | 9.0 |
| EBITDA (EUR million) | -0.2 | 7.9 |
| Operative EBITDA (EUR million) | -0.1 | –0.4 |
| Operating profit/loss (EUR million) | -2.0 | 6.4 |
| Profit/loss before taxes (EUR million) | -2.0 | 6.4 |
| Profit/loss for the period (EUR million) | -2.1 | 6.1 |
| Average number of personnel | 50 | 51 |
| Number of personnel at the end of the period | 49 | 51 |
| Equity ratio (%) | 89.2% | 91.3% |
| Undiluted earnings per share (EUR) | -0.14 | 0.42 |
| Diluted earnings per share (EUR) | -0.14 | 0.41 |
| Shareholders' equity per share (EUR) | 1.06 | 1.16 |
| Average number of shares during the period | 14,901,904 | 14,764,411 |
| Number of shares at the end of the period | 14,952,041 | 14,886,843 |
Net sales 2014–2018,

EUR thousand Personnel 2014–2018

OBJECTIVE: early detection and prevention of diseases
ACTIONS: commercialising new products and supporting international distribution channels
EFFECTS: enabling the correct and sufficient treatment, preventing serious diseases, and impacting public health
Review by the President & CEO
Review by the President & CEO
Strategy and quality History Corporate governance Financial statements

Review by the President & CEO
During 2018 our growth path continued and at the same time we improved our profitability and cash flow.
We launched the new Acetium® smoking cessation product, continued developing our existing products, renewed our management team and made good progress in our most critical studies.
Our Net Sales grew 11% compared to 2017 due to United Kingdom, Middle-East, Russia and Acetium® sales. During H2/2018 our growth was only 2% due to a delay in the re-registration of one of our GastroPanel® products in China. We expect to get registration completed by the end of H1/2019. Our Operative EBITDA adjusted for items affecting comparability was EUR -0.1 million (EUR -0.4 million), which represents an improvement of EUR 0.2 million compared to previous year. Our cash flow improved compared to 2017 and cash at the end of the period amounted to EUR 1.4 million (EUR 1.3 million).
We expect the growth to continue during 2019 despite of delay in China re-registration process regarding GastroPanel®.
We continued to expand our distributor network by making new agreements and rearranging existing agreements. We made the following agreements in 2018 concerning the distribution of Biohit's diagnostic products: BioVendor – Laboratorní medicína A.S. will sell our diagnostic tests in Czech Republic and Montebello AS in Norway. Trans
Biohit in brief Review by the President & CEO
Continental Medical Products is our new distributor in the Caribbean Islands. Dow Biomedica was nominated as new distributor in the important South-Korean market. AJ Mirza Pharma is our new distributor in Pakistan. Diagnostics and Acetium® (Etium) distribution in Mexico has been discontinued for now and we are actively searching for the new distibutor.
During the review period, Save Health D.o.o in Serbia and Scientronics in Cyprus received exclusive right to sell Acetium®. In Greece we signed an agreement with Pharmathen Hellas S.A. for the distribution of the smoking cessation product Acetium® lozenge. Furthermore, we signed distribution agreement with Oriola Oyj regarding smoking cessation product Acetium® Lozenge. The product is distributed in the pharmacies and
other Oriola's distribution channels. In September we signed contract with Retail Partner ApS for the distribution of the smoking cessation product Acetium® lozenge in Denmark and Sweden. At the end of the 2018 we signed contracts for Acetium® lozenge distribution with MHD Pharma in Vietnam and UAB Osteca in Lithuania.
During the review period, the Biohit Group employed 50 (51 in 2017) people on average. 42 (41) of whom were employed by the parent company and 8 (10) by the subsidiaries. At the end of the year 2018, the Group employed 49 (51) personnel, of whom 41 (42) were employed by the parent company and 8 (9) by the subsidiaries.
Semi Korpela President & CEO
Strategy
We aim to become the world's leading biotechnology company in selected markets promoting gastrointestinal well-being:


We are working long-term to make our operations simpler and more efficient. We always take into account customer benefits.
Our competitive advantage is a quick, flexible and cost-efficient distribution chain where customers play a key role. We are making our processes more efficient by continuously digitalising and automating our operations and services.
Whenever we make a decision, we consider how the decision will benefit customers and how it will enable innovation for customers.
Our target is to constantly improve quality. We monitor our operations and make all required improvements rapidly. We take more proactive measures than reactive measures.

The Acetium® tablet for smoking cessation
The Acetium® lozenge for smoking cessation was launched on the Finnish market in September 2018, accompanied by a large-scale advertising campaign. A comprehensive range of distribution channels was obtained, covering pharmacies, R-kioski shops, S Group and Kesko grocery stores, health food stores, Lidl, Minimani, Keskinen, Tokmanni and Halpahalli.
Launch campaigns continued throughout the autumns 2018 on TV channels, radio stations, billboards and online.
Our messages were pointed for both consumers and healthcare professionals, who have a key position in supporting and contributing smoking cessation. Co-operating with nurses and doctors is in a crucial position.
The Acetium® lozenge is a natural and effective product that helps smokers to give up without consuming addictive nicotine. It also has none of the potential side-effects of medical detoxification methods. The lozenge is used while smoking, and it effectively binds carcinogenic acetaldehyde that dissolves in saliva during smoking.
Acetium® has attracted widespread interest among consumers and healthcare professionals as a nicotine-free alternative is safer for the health and more natural.

History
Biohit's success is primarily based on its aggressive innovation and patenting strategy developed by Professor Osmo Suovaniemi, MD, PhD. He can be considered a pioneer of this strategy, which has demonstrated a successful model and path for small and large companies in Finland.
Biohit's roots extend back to the 1970s, to two companies established by professor Osmo Suovaniemi, M.D., Ph.D (Labsystems Oyj in 1971 and Eflab Oy in 1978). They developed the first single and multichannel precision pipettes with adjustable volumes, which revolutionised liquid handling in laboratories and also made it much safer. The same innovative team also developed the first instrument based on vertical photometry, the Titertek Multiskan, as well as diagnostic tests for the diagnosis of infections and cancers. When Suovaniemi left in 1986, these companies were the largest and fastest growing companies in the industry in Finland.
The aggressive innovation and patenting strategy forms a strong basis for enterprises – whether small or large – to succeed in international competition and create well-being for our society. Giving up on the aggressive innovation and patenting strategy
often precedes the onset of recession in Finland and abroad. (www.biohithealthcare.com/en/ path-to-success).
Analysis and liquid handling devices based on innovations created by Labsystems, Eflab and Biohit have been taken into use worldwide, enabling the massive development of immunoassays using non-radioactive markers based on Suovaniemi's vertical measurement invention. These immunoassays have been used for research and diagnostics of infections and cancer. Immunoassays and vertical measurements have developed into global industrial norms, revolutionising laboratory practices worldwide in the 1970s and 1980s. They have also enabled the development of the GastroPanel test and Biohit's other immunoassays (www.biohithealthcare.com/additional-information).

Osmo Suovaniemi established Biohit Oy in 1988.
Biohit in brief Review by the President & CEO Strategy and quality History Corporate governance Financial statements
• The company is listed on the Helsinki Stock Exchange on 18 June 1999. At that point, Biohit had 16 patents in Finland, while 20 other newly listed companies had 11 patents between them.
Biohit in brief Review by the President & CEO Strategy and quality History Corporate governance Financial statements
• Biohit launches a calprotectin test, which is used for diagnosing and monitoring inflammatory diseases of the bowel (IBS and IBD), as well as the Biohit Active B12 test, based on vertical measurement, for identifying vitamin deficiency.
• Biohit launches the ColonView FIT test, which identifies faecal occult blood and can be used to screen for and diagnose colorectal cancer. Several countries are using the test around the world. (www.biohithealthcare.com/additional-information)
Corporate Governance Statement 2018
Biohit Oyj has prepared this Corporate Governance Statement on the basis of Section 54 of the Finnish Corporate Governance Code for listed companies issued by the Securities Market Association. Biohit Oyj has appended its remuneration statement for the 2018 financial period to this statement.
The Corporate Governance Statement has been issued separately from the Report of Biohit Oyj's Board of Directors. The Board of Directors reviewed the Statement at its meeting on 18 February 2019.
The Report of the Board of Directors, the Auditor's Report and the full Corporate Governance Statement are available at www.biohit.fi/investors.
Biohit Oyj is a Finnish public limited company whose series B shares are listed on Nasdaq Helsinki in the Small cap/Healthcare group. Biohit Group (hereinafter referred to as "Biohit") comprises the parent company, Biohit Oyj, and its foreign subsidiaries, which primarily focus on sales and
marketing for Biohit Oyj's products. Biohit is headquartered in Helsinki.
Biohit's governance complies with applicable legislation, standards and recommendations concerning public listed companies, the regulations of Nasdaq Helsinki Ltd, and Biohit Oyj's Articles of Association. Biohit Oyj has administered its affairs in compliance with the corporate governance code for Finnish listed companies 2015, and this Statement has been prepared in accordance with the code. The Corporate Governance Code is available at www.cgfinland.fi.
One of the members of the five-person Board of Directors is independent of the company, so the company does not fulfil recommendation number 10 stating that the majority of the members of the Board of Directors must be independent of the company. The company strives to comply with high international standards of corporate governance and the key principles of corporate governance among Finnish listed companies.
The highest decision-making power at Biohit is exercised by the company's shareholders at the Annual General Meeting. The company's Board of Directors supervises the administration and organisation of the company and the Group's earnings trends. The President & CEO is responsible for operative management and he is assisted by the Management Team.
In 2018, Biohit Oyj held its Annual General Meeting on 25 April 2018 in Helsinki. 2,878,310 series A shares and 5,054,431 series B shares were represented at the meeting, corresponding to 53.28% of all of the shares in the company and 87.67% of the votes. The meeting was attended by three of the five members of the Board of Directors, the President & CEO and the principal auditor.
Review by the President & CEO Strategy and quality History Corporate governance Financial statements
In 2018, Biohit Oyj held also its Extraordinary General Meeting on 16 August 2018 in Helsinki. 2,108,000 series A shares and 4,840,686 series B shares were represented at the meeting, corresponding to 46.64% of all of the shares in the company and 65.80% of the votes. The meeting was attended by two of the five members of the Board of Directors, the President & CEO and the principal auditor. Additionally new Board candidate which was elected was present.
The Board of Directors, which comprises 5–7 members elected by the Annual General Meeting, is responsible for the administration and appropriate organisation of Biohit's business operations. Proposals concerning membership of the Board of Directors are prepared by the Board of Directors. Biohit has defined the principles applying to diversity within the Board of Directors in accordance with recommendation 9 of the corporate governance code. Biohit's objective is for both sexes to be represented on the company's Board of Directors. In line with this objective, the Board of Directors had members of both sexes until October 2018 resignation by Stina Syrjänen.
The Board of Directors elects a chairman from amongst its members.
Board members' terms of office run from the date of their election by the AGM until the end of the next AGM.
The Board's areas of responsibility are stated in the written rules of procedure approved by the Board. They are as follows:
The Board's decision-making is based on reports prepared by the company's operative management on the operational development of the Group and its business units.
The Chairman is responsible for convening Board meetings and arranging the work of the Board. The Board convenes 5–12 times per year, usually meeting once per month or once every two months, and the meeting schedule for the entire term is confirmed in advance. When necessary, Board meetings are held more frequently or by teleconference.
Until the Annual General Meeting held on 25 April 2018, the following five people were on the Board of Directors: Osmo Suovaniemi (chairman), Eero Lehti, Stina Syrjänen, Franco Aiolfi and Matti Härkönen. At the Annual General Meeting on 25 April 2018, Osmo Suovaniemi (chairman), Eero Lehti, Stina Syrjänen, Franco Aiolfi and Matti Härkönen were re-elected to the Board of Directors until the end of the Annual General Meeting in 2019. The Board of Directors elected Osmo Suovaniemi as its chairman.
At the Extraordinary General Meeting on 16 August 2018 Liu Feng (Managing Director of Biohit Healthcare (Hefei) Co. Ltd) was elected as new member to serve until the end of the Annual General Meeting in 2019.
Stina Syrjänen resigned from the Board of Directors on 16 October 2018.
Biohit Oyj's Board of Directors convened 5 times in 2018 (6 times in 2017). The average attendance was 91 per cent (91 per cent).
Biohit in brief Review by the President & CEO Strategy and quality History Corporate governance Financial statements
Matti Härkönen (b. 1933), MD, PhD, Emeritus Professor
Eero Lehti (b. 1944), MSc (Soc. Sci.), holder of the Finnish honorary title of "kauppaneuvos", honorary doctor of economics
Liu Feng (b. 1972), General manager of Hefei Medicine Co., Ltd, Owner of Biohit Healthcare (Hefei) Co., Ltd.
The scope of Biohit's business operations does not require the appointment of an Audit Committee, and no other committees have been appointed to assist the Board.
The President & CEO is responsible for the day-to-day management of the company in accordance with the instructions and regulations issued by the Board of Directors. The President & CEO of the parent company is elected by the Board and also acts as Group President. He also ensures the appropriate organisation and legality of the company's accounting and asset management. The terms of employment of the President & CEO are based on a written contract that is approved by the Board of Directors. The President & CEO cannot be elected Chairman of the Board. Semi Korpela, MSc (Econ.) was the President & CEO of Biohit during the financial period.
The composition and areas of responsibility of the Group's Management Team were as follows: Semi Korpela (President & CEO), Jukka Kainulainen (finance, ICT, HR), Minna Mäki (R&D and production), Ilari Patrakka (sales and marketing) and Daniela Söderström (quality and registration).
The Managing Directors of the subsidiaries are responsible for the management of subsidiary operations and report to the President & CEO of the parent company. The subsidiaries are responsible for the sales and marketing of Biohit's products in their market areas. The managers of subsidiaries operate under the management and supervision of Biohit's President & CEO. In 2018, the Managing Directors of Biohit's subsidiaries were: Graham Johnson (United Kingdom) and Franco Aiolfi (Italy).
The personal details and shareholdings of Biohit's Board of Directors and operative management are available at www.biohit.fi/investors
Review by the President & CEO Strategy and quality History Corporate governance Financial statements
The Annual General Meeting approves the fees of Biohit Oyj's Board of Directors. A decision was made at the Annual General Meeting on 25 April 2018 to pay a fee of EUR 1,500 per meeting to the chairman and the other members of the Board of Directors.
The remuneration paid to the other members of Biohit Oyj's Board of Directors is decided by the company's Board of Directors in accordance with the company's rules on related-party transactions, which are described on section "related-party transactions".
The Board approves the President & CEO's remuneration and terms of employment. The notice period of the President & CEO and the members of the Management Team and the remuneration for these parties during the notice period is determined in accordance with the Employment Contracts Act.
The President & CEO approves the remuneration and terms of employment of members of the Management Team. Biohit's Board of Directors approves the principles of the incentive schemes for Management Team members and the President & CEO. Bonuses are determined on the basis of the net sales and earnings trends in each person's area of responsibility. The maximum bonus that can be received depends on each person's monthly salary and can total no more than 40% of annual salary. No bonus was paid to the President & CEO and Management Team members in 2018.
The President & CEO approves the salaries and profit-based incentives of subsidiaries' Managing Directors in accordance with the instructions provided by Biohit's Board of Directors. Profit-based incentives are dependent on sales and profitability trends for each unit's product segments.
In 2013, Biohit introduced an incentive system offering stock options to company managers and employees. A total of 65,198 new series B shares in the company were subscribed under stock options in 2018. The share subscription price under the stock options in question was EUR 2.2766 per share. On 31 December 2018, there were 113,552 stock options in circulation. The deadline for exercising
stock options under the options programme is 31 May 2019. According to the terms and conditions of the stock option programme, stock options can be executed or sold on when they have been earned.
No new stock option programmes are in effect for 2019. CEO and the management team members are covered by an incentive scheme, which is based on the reaching of annually set targets. The targets are mainly linked to the net sales and results of the whole company. The target levels of management's bonuses are 20% of the total compensation. The Board of Directors will set and approve the financial targets for the CEO and the Management Team members
No other pension arrangements, beyond those mandated by law, have been made with the Managing Directors of Group companies.
President & CEO Strategy and quality History Corporate governance Financial statements
| Member of the Board of Directors |
Position on the Board of Directors |
Board of Directors' fees (€ 1,000) |
Other remuneration (€ 1,000) |
Total remuneration (€ 1,000) |
|---|---|---|---|---|
| Osmo Suovaniemi | Chairman | 8 | 205 | 213 |
| Matti Härkönen | Member | 8 | – | 8 |
| Eero Lehti | Member | 5 | – | 5 |
| Stina Syrjänen | Member | 5 | – | 5 |
| Franco Aiolfi | Member | 8 | 27 | 35 |
| Liu Feng | Member | 5 | – | 5 |
| Total | 36 | 232 | 268 |
| 2018 | 2017 | |
|---|---|---|
| Franco Aiolfi, Euroclone S.p.A | 66 | 82 |
| Matti Härkönen, Oy Tech Know Ltd. | 55 | 53 |
| Franco Aiolfi, Biobrick | 25 | 25 |
| Total | 146 | 160 |
During the financial period that ended on 31 December 2018, the remuneration paid to members of the parent company's Board of Directors totalled EUR 36,000 (EUR 33,100 in 2017). Osmo Suovaniemi was paid EUR 213,000 (EUR 201,000 in 2017) for his services as a member of the scientific advisory board. Board member Franco Aiolfi is the Managing Director of Biohit Oyj's subsidiary, Biohit Healthcare S.r.l. and he received remuneration of EUR 35,000.
Biohit has a consultancy agreement with Oy Tech Know Ltd, a company controlled by Board member Matti Härkönen. On the basis of this agreement, Oy Tech Know Ltd was paid consultancy fees of EUR 55,400 based on the work done by Matti Härkönen. Biohit has agreements with Euroclone S.p.A and Biobrick, and the companies are controlled by Board member Franco Aiolfi. Companies deliver finance, IT, quality and premises services to Biohit Italy. On the basis of these agreements, Euroclone S.p.A and Biobrick were paid EUR 91,000 during the 2018 financial period.
| Salary and benefits (€ 1,000) |
2018 | 2017 |
|---|---|---|
| Salary | 202 | 202 |
| Short-term incentives | – | – |
| Long-term incentives | 86 | 291 |
| Total | 288 | 494 |
| Salary and benefits (€ 1,000) |
2018 | 2017 |
|---|---|---|
| Salary | 524 | 553 |
| Short-term incentives | – | – |
| Long-term incentives | 11 | 263 |
| Total | 535 | 816 |
Biohit's internal control is responsible for ensuring that the Group carries out its business operations within the framework of current regulations and legislation and in accordance with the instructions of the Board of Directors. Internal control seeks to ensure that the Group operates with maximum efficiency and that efforts are made at various levels of the organisation to achieve the objectives set in the strategy approved by the Board of Directors. Risk management is geared towards supporting the achievement of these objectives by anticipating and managing business-related risks.
Biohit's business operations and administration aim to realise the company's values, of which the most important is to promote health and wellbeing through innovation. Biohit will continue to focus on its diagnostics business and products that bind acetaldehyde – the areas where the company conducts global operations in manufacturing, sales and marketing.
Biohit's control environment is defined by the Board of Directors, which, as the highest administrative body, is responsible for organising internal control. The President & CEO is responsible for maintaining the efficiency of the control environment and the functionality of internal control. Biohit's financial department is responsible for the functionality of financial reporting as well as the interpretation and application of financial statement standards in line with the separately approved instructions.
In the assessment of risks related to financial reporting, Biohit's objective is to identify the major risks associated with the Group's business operations and environment. The cost-effective management and monitoring of these risks will then ensure that the company's strategic and operational targets can be reached as intended.
The Board of Directors carries the main responsibility for risk assessment and monitoring the implementation of risk management. The President & CEO works with the parent company's operative management and subsidiaries' managers to ensure that the Group's risk management is duly arranged. The parent company's operative management is responsible for identifying and managing the risks involved within each business area, while the subsidiaries' Management Teams are responsible for those in their own market areas. Risk management is one of the areas covered by
Biohit's internal control processes, which regularly
Review by the President & CEO Strategy and quality History Corporate governance Financial statements
monitor the risks associated with the company's business operations, identify any changes and, if necessary, take appropriate action to hedge against them. Risk management focuses on ensuring the continuity of business operations and preventing financial misconduct.
Internal control measures are integrated into the Group's general business management and reporting process. The subsidiaries report to Group Management on business and earnings trends and the most significant deviations on a monthly and quarterly basis. The Group's Management Team reports to the Board of Directors on the overall development of business; these two bodies, together with the President & CEO, decide on overall corporate strategies and procedures guiding the operations of the Group.
The subsidiaries' Boards follow business developments and ensure that the parent company's approved instructions and guidelines are followed. As a rule, the Boards of Directors of the subsidiaries meet monthly. Board work in the subsidiaries is based on financial reports and the written monthly and annual reports drawn up by subsidiary management.
Biohit's business control is carried out in accordance with the management system described above. The company provides the reporting systems necessary for business and financial management. The financial department of the parent company provides instructions for drawing up annual and interim financial statements and prepares the consolidated financial statements.
The parent company's finance department retains central control of funding and administrative matters within the framework of the instructions provided by the Board of Directors and the President & CEO, and is also responsible for the management of interest and exchange rate risks. The Managing Directors of the subsidiaries ensure that the subsidiaries' reporting is carried out in accordance with the instructions given by the Group's Management Team.
The parent company's administration department controls and provides instructions on Group-level personnel policies and any agreements made within the Group.
Biohit aims to provide all of its stakeholders with information about the company's operations in a proactive, consistent and timely manner. The company seeks to take the special requirements
and interests of all its stakeholders into account in its communications in order to increase confidence in the company and thereby promote its business operations. Biohit's Board of Directors has approved an information release policy with a view to ensuring the accuracy and reliability of any information released. The policy also specifies who is responsible for communications in different situations.
Biohit's financial department regularly provides information on processes related to financial administration reporting. This ensures the realtime availability of data, which is a prerequisite for efficient internal control.
Financial administration guidelines and the company's information release policy aim to ensure the promptness and comprehensiveness of communications and the release of information required for internal control purposes.
The efficiency of internal controls on financial reporting is overseen by the Board of Directors, the President & CEO, Management Team members, and the Managing Directors of subsidiaries. Control focuses on following weekly and monthly financial reports and forecasts, and analysing any deviations from business plans. Monitoring is performed at all Board and Management Team meetings where reports are reviewed. It is supported by regular
Review by the President & CEO Strategy and quality History Corporate governance Financial statements
contact between Group Management and the company's auditor, and analysis of any deviations, which occurs at least once per quarter.
The audit frameworks for the Group's subsidiaries and key audit areas are jointly defined by the Group's financial management and the chief auditor. Biohit has not appointed a separately organised function for internal auditing purposes.
The Group has internal control reporting systems required for financial management and monitoring business development. The reporting systems produce monthly financial data, so that financial management can ensure compliance with the parent company's approved instructions on matters such as authorisation.
The Group's auditor and the auditors of each subsidiary evaluate the effectiveness of the internal control system both in connection with the external audit and through spot checks throughout the financial period.
The auditor elected by the AGM is responsible for Biohit's statutory audit. According to the Articles of Association, the company must have one auditing body approved by the Central Chamber of Commerce. The 2018 Annual General Meeting re-elected auditing firm PricewaterhouseCoopers Oy as the company's auditor for a one-year term, with Pasi Karppinen, Authorised Public Accountant, as chief auditor.
The 2018 Annual General Meeting decided to pay auditor's fees in accordance with the auditor's invoice. The Group's invoiced auditors' fees for the 2018 financial period totalled EUR 110,000 (EUR 69,000 in 2017). In addition to this, PricewaterhouseCoopers Oy was paid a total of EUR 14,000 for other services (EUR 30,000 in 2017).
The company keeps a list of its related parties, and it regularly engages in transactions with some of these parties. These transactions are related to the company's ordinary business activities, they are appropriate in terms of the company's operations and they are executed on ordinary market terms. The company's financial management monitors and supervises related-party transactions as part of the company's normal reporting and supervision practices. Relevant transactions between the company and its related parties are reported annually in the notes to the company's consolidated financial statements. The company's Board of Directors makes all relevant decisions concerning related-party transactions. Decision-making is based on particularly thorough preparation and appropriate reports, statements and estimates. Preparation of related-party transactions, decisionmaking and approval have been arranged to take account of disqualification rules and appropriate decision-making entities.
Biohit applies the Guidelines for Insiders approved by Nasdaq Helsinki Ltd, as well as any relevant amendments.
Biohit's President & CEO is responsible for insider control. He ensures that people who handle insider information are aware of insider regulations and adhere to trading restrictions. Insiders are not allowed to trade Biohit Oyj securities for 30 days before the publication of the company's financial statement bulletin and interim reports. Insiders participating in projects are not allowed to trade shares in Biohit before an announcement has been made of the continuation or discontinuation of a project.
Information on the shareholdings of Biohit's insiders and their trading activity is available on Biohit's website at www.biohit.fi/investors.
Board of Directors


EERO LEHTI, b. 1944



Management Team


JUKKA KAINULAINEN, b. 1982



Information for shareholders
Biohit Oyj's Annual General Meeting will be held at 5pm on Wednesday 24 April 2019 at the Crowne Plaza hotel, Mannerheimintie 50, 00260 Helsinki, Finland. Shareholders who are listed on the company's register of shareholders and who wish to attend the Annual General Meeting should register by 10am on Wednesday 17 April (the registration must arrive by this date).
Register for the Annual General Meeting: Online: www.biohithealtcare.com/investors By telephone: +358 9 773 861, Mon–Fri, 9am–4pm By post: Biohit Oyj, Annual General Meeting, Laippatie 1, 00880 Helsinki, Finland
On 31 December 2018, the parent company's distributable assets (unrestricted equity) amounted to EUR 11,324,090.66, including the loss for the financial period of EUR 1,515,586.40. The Board of Directors proposes to the Annual General Meeting that no dividend be distributed by the company for the most recent financial period.
Total number of shares: 14,952,041 (14,886,843 in 2017)
Series A shares (20 votes per share): 2,975,500 (2,975,500 in 2017) Series B shares (1 vote per share): 11,976,541 (11,911,343 in 2017)
Biohit Oyj's series B shares are listed in the Nasdaq Helsinki Ltd Small Cap group. The shares are traded under the symbol BIOBV. More detailed information about Biohit Oyj's shares is provided in the notes to the consolidated financial statements and on the company's website at www.biohithealtcare.com/investors.
The financial reviews and other stock exchange releases published by Biohit are available on the company's website at www.biohithealtcare. com/investors. You can also subscribe to receive financial communications by email using the subscription form on the website.
Wednesday 14 August 2019 Interim report, January–June (H1)
Biohit observes a silent period of 30 days before results are published. During this period, Biohit's management and other personnel will not provide information about the company's financial position or market-related comments, nor will they meet with representatives from equity markets or the financial media. However, if an event that requires immediate publication takes place during the silent period, Biohit will publish information without delay in accordance with disclosure regulations. In such cases, the company is able to comment on the event. Summary of stock exchange releases in 2018
| 5 January 2018 | Biohit Oyj's comments on its Chinese distributor´s production capacity expanding |
|
|---|---|---|
| 30 January 2018 | Pharmathen Hellas S.A. to distribute Acetium® lozenge in Greece |
|
| 15 February 2018 | Dow BioMedica to distribute Biohit GastroPanel® in Korea | |
| 20 February 2018 | Changes to Biohit Oyj's Management Team | |
| 22 February 2018 | Biohit GastroPanel® test helps reducing unnecessary gastroscopies in pre-operative evaluation of the patients referred for bariatric surgery |
|
| 23 February 2018 | Montebello to distribute Biohit products in Norway | |
| 28 February 2018 | Biohit Group Financial Statement Release 2017 | |
| 12 March 2018 | Oriola to distribute Acetium® lozenge in Finland | |
| 4 April 2018 | NOTICE OF BIOHIT OYJ'S ANNUAL GENERAL MEETING | |
| 13 April 2018 | BIOHIT OYJ'S OWNERSHIP IS EXPANDING | |
| 25 April 2018 | Decisions of the Annual General Meeting of Biohit Oyj | |
| 30 April 2018 | Changes to Biohit Oyj's management | |
| 31 May 2018 |
| 19 June 2018 | Constitutive meeting of Biohit Oyj´s Board of Directors | |
|---|---|---|
| 2 July 2018 | NOTICE OF BIOHIT OYJ'S EXTRAORDINARY GENERAL MEETING | |
| 30 July 2018 | Changes to Biohit Oyj´s management | |
| 16 August 2018 | Decisions of the Extraordinary General Meeting of Biohit Oyj | |
| 22 August 2018 | Biohit group half year financial report 2018 | |
| 3 September 2018 | Retail Partner ApS to distribute Acetium® lozenge in Denmark and Sweden |
|
| 5 September 2018 | Biohit GastroPanel® accurately predicted the progression of atrophic gastritis and its transition to gastric cancer in a European multicenter trial |
|
| 7 September 2018 The results of the migraine study will be delayed from the previously reported schedule |
||
| 10 September 2018 | A new chance for a smoke-free life - Acetium® lozenges available across Finland |
|
| 16 October 2018 | Stina Syrjänen resigns from Biohit Oyj's Board of Directors | |
| 30 November 2018 | Biohit Oyj´s Financial Reporting and Annual General Meeting in 2019 | |
| 31 December 2018 | Chief Medical Director Kari Syrjänen will retire from Biohit Oyj |
Financial statements
Review by the President & CEO Strategy and quality History Corporate governance Financial statements
| Report by the Board of Directors 2018…………………………… | 26 |
|---|---|
| CONSOLIDATED FINANCIAL STATEMENTS * ………………… |
32 |
| Consolidated comprehensive income statement and balance sheet* …………………………………………………… |
32 |
| Statement of changes in consolidated shareholders' equity*………………………………………………… |
35 |
| Consolidated cash flow statement* …………………………… |
36 |
| Notes to the consolidated financial statements* ……… |
38 |
| Key indicators ……………………………………………………………… |
66 |
|---|---|
| Shares and shareholders ……………………………………………… |
68 |
| Formulae for calculating key indicators ………………………… |
70 |
| PARENT COMPANY'S FINANCIAL STATEMENTS * ………… |
71 |
| Board of Director's proposal regarding the distribution of profits * …………………………………………… |
82 |
| Auditor's Report …………………………………………………………… |
83 |
BIOHIT OYJ ANNUAL REPORT 2018 25
*part of the official financial statements
Report by the Board of Directors 2018
In 2018, Biohit's net sales increased by 10.6% over the previous year. Biohit's balance sheet provides a strong foundation for building the business and exploiting the great potential of the products. Our company's equity ratio at the end of 2018 was 89.2% (91.3%). At the end of the financial period, the company's financial assets amounted to EUR 5.5 million (EUR 5.6 million).
| 1–12/2018 | 1–12/2017 | |
|---|---|---|
| Net sales (MEUR) | 9.9 | 9.0 |
| Operating profit/loss (MEUR) | –2.0 | 6.4 |
| Profit/loss before taxes (MEUR) | –2.0 | 6.4 |
| Profit/loss for the period (MEUR) | –2.1 | 6.1 |
| Average number of personnel | 50 | 51 |
| Number of personnel at the end of the period | 49 | 51 |
| Equity ratio (%) | 89.2 % |
91.3 % |
| Earnings per share (EUR), Undiluted | –0.14 | 0.42 |
| Shareholders' equity per share (EUR) | 1.06 | 1.16 |
| Average number of shares during the period | 14,901,904 | 14,764,411 |
| Number of shares at the end of the period | 14,952,041 | 14,886,843 |
*In 2017 we recognized EUR 8.4 million capital gain regarding divestment of Biohit Healtcare (Hefei) Co. Ltd, which is visible in the 2017 profit for the period. The patent worth of EUR 7.1 million was capitalized relating this transaction which is depreciated EUR 1.5 million annually until end of 2021.
President & CEO Strategy and quality History Corporate governance Financial statements
Biohit's product portfolio consists of diagnostic tests, analysis systems, acetaldehyde binding products, monoclonal antibodies, as well as service laboratory operations. The entire product and service portfolio is reported under a single segment.
Net sales grew by 10.6% from the previous year. The proportion of international operatorions of net sales decreased from the previous year and, in 2018, amounted to 95.6% (95.7%).
The operating loss was EUR 2.0 million (profit EUR 6.4 million).
| EUR million | 2018 | 2017 |
|---|---|---|
| Net sales | 9.9 | 9.0 |
| Operating income | –2.0 | 6.4 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Operating income | –1,965 | 6,356 |
| Depreciation and amortization | 1,807 | 1,589 |
| Items affecting comparability | 20 | –8,313 |
| Operating EBITDA | –138 | –368 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| IFRS 2 share-based payments | –20 | –85 |
| Share of the profit/loss from Biohit HealthCare (Hefei) Co. Ltd |
198 | |
| Share of the impact on profit/ loss from the dissolution of Biohit HealthCare (Hefei) Co. Ltd * |
–596 | |
| Biohit Healthcare (Hefei) Co. Ltd, capital gain on share |
8,796 | |
| Total | –20 | 8,313 |
* The impact on profit/loss is due to the dissolution of the consolidation in the balance sheet of Biohit HealthCare (Hefei) Co. Ltd, which was done using the equity method.
On the 31 December 2018, the balance sheet totalled EUR 17.9 million (EUR 18.9 million 31 Dec 2017). Biohit's balance sheet provides the necessary foundation for building new business and for utilising the significant potential of the company's products. At the end of the reporting period, our equity ratio stood at 89.2% (91.3%).
Biohit Oyj has a stable financing position, which allows for the necessary actions towards creating an international distributor network as well as the development and commercialization of the new products. On 31 December 2018 company's financial assets totalled EUR 5.5 million (EUR 5.6 million) which does not include Genetic Analysis AS shares.
Despite significant financial investments the company has managed to keep its working capital on a good level and the management believes that working capital will cover the operations for the next 12 months and the company is not depended on external financing to be able to guarantee the continuity of its operations. Cash flow from operating activities was during the 1-12/2018 reporting period EUR -0.1 million. Company's management assessment is that company's ability to continue its operations is good and there are no indications towards events or circumstances that alone or together might give a significant reason to doubt the organisation's ability to continue its operations.
R&D operations focus on innovations, as well as product development and further improved usability. Biohit also employs external experts and subcontractors in its R&D operations. Development expenditure has not been capitalised. Research and development expenditure during the 1-12/2018 reporting period amounted to EUR 1.3 million (EUR 1.2 million), of which the second half-year accounted for EUR 0.7 million (EUR 0.5 million).
During the review period we completed CE marking and commercialization project for the Acetium® lozenge smoking cessation product. The product was launched in Finland in September 2018. In addition, we continued the development of the GastroPanel® Quick Test, intended as the first-line diagnostic test for dyspeptic patients, and the ColonView ELISA Test, intended for screening
Review by the President & CEO Strategy and quality History Corporate governance Financial statements
of colorectal cancer and its precursors. The production processes of both test platforms were also standardized and stabilized in order to initiate external clinical validation studies and the CE marking process. Necessary ethical committee approvals have been sought for the initiation of external clinical validation studies in Finland.
Gross investments during the 1-12/2018 reporting period totalled EUR 0.0 million (EUR 0.2 million).
During the review period, the Biohit Group employed 50 (51 in 2017) people on average. 42 (41) of whom were employed by the parent company and 8 (10) by the subsidiaries. At the end of the year 2018, the Group employed 49 (51) personnel, of whom 41 (42) were employed by the parent company and 8 (9) by the subsidiaries.
Biohit's key risks are related to the success of registration processes, the selection and development of new market areas and distribution channels, personnel recruitment and political decision-making affecting the progress of screening programs. Significant short-term risks are associated with the successful selection of new market areas, the timing of expansion into selected markets and product success in these markets. The 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. For this reason, it is not possible to accurately assess the time taken for the authorities 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 in portfolio management is sufficient diversification across different asset classes, investment instruments and counterparties. The investment portfolio is subject to interest rate risk, which is managed by adjusting the duration of the portfolio. The rise of one percentage point in interest rates would have a negative impact of EUR 0.1 million on the fair value of the investment portfolio.
The Group's investment in unlisted shares of Genetic Analysis AS is subject to changes in the terms of transactions involving the company's shares that take place between third parties, which are used as input data in the valuation of Biohit's holding in the company. A negative change of 15% in the valuation of Genetic Analysis AS shares, would have a negative pre-tax impact of EUR 0.6 million on the Group comprehensive income. Market value change impact was +0.6 million in Group comprehensive income during the review period. Genetic Analysis AS valuation changes have no effect on cash flow.
Biohit's operation's customer base is widely diversified, with the exception of GastroPanel® sales in China, which currently represents a major single business for Biohit. Due to this reason, the company is dependent on the continuation of this business relationship. Otherwise, the company is not significantly dependent on individual customers or deliveries. Most of the company's business is conducted in euro, and the indirect effects of currency exchange rate fluctuations are considered insignificant.
Biohit expects the growth to continue during 2019 despite of GastroPanel®'s re-registration delay in China.
"Biohit expects its 2019 Net Sales growing comparing 2018 (previous year EUR 9.9 million)."
Intangible asset depreciation relating divestment of Biohit Healtcare (Hefei) Co. Ltd. shares in 2017 impacts Biohit's result EUR 1.5 million annually until year 2021. Patent worth of 7.1 million was capitalized for the 2017 financial period relating this transaction.
Biohit has made several innovations in last 30 years and taken significant social responsibility in developing preventive healthcare. September
2018 we launched Acetium® lozenge in Finland. Acetium® lozenge is effective and safe product which helps smokers to quit smoking without consuming addictive nicotine or incurring any of the potential side-effects of medicinal intervention methods. The lozenge also contains a small amount of xylitol,
which improves overall oral hygiene. Usage of Acetium® lozenge is started just before smoking and is continued whole duration of smoking the cigarette. Acetium® lozenge effectively removes carcinogenic acetaldehyde that dissolves in saliva during smoking. Also mouth microbes produce acetaldehyde from alcohol, which is removed by Acetium® lozenge. The product launch is ongoing in several distribution channels in Finland and will continue in the rest of the Europe and Asia during 2019.
During the review period Acetium® lozenge was granted patents until 12 September 2028 in all nine Eurasian countries including Russia and Belarus. Acetium® lozenge has also been granted a European patent: EP 2 197 436 B1, Sucking tablet for use in reducing tobacco and/or alcohol dependence. In addition to this patent has been granted in all African countries and Mexico. There are several pending patent applications in other countries.
The new GastroPanel® quick test, intended for point-of-care testing (POCT), can be conducted using a fingertip blood sample during a primary care appointment. The GastroPanel® quick test will be available in Europe as soon as the performance and clinical testing required for the CE mark are completed. We expect to have CE mark available during H2/2019.
We continued to expand our distributor network by making new agreements and rearranging existing agreements. We made the following agreements in 2018 concerning the distribution of Biohit's diagnostic products: BioVendor – Laboratorní medicína A.S. will sell our diagnostic tests in Czech Republic and Montebello AS in Norway. Trans Continental Medical Products is our new distributor in the Caribbean Islands. Dow Biomedica was nominated as new distributor in the important South-Korean market. AJ Mirza Pharma is our new distributor in Pakistan. Diagnostics and Acetium® (Etium) distribution in Mexico has been stopped for now and we are actively searching for the distibutors for both products.
During the review period, Save Health D.o.o in Serbia and Scientronics in Cyprus received exclusive right to sell Acetium®. In Greece we signed an agreement with Pharmathen Hellas S.A. for the distribution of the smoking cessation product Acetium® lozenge. Furthermore, we signed distribution agreement with Oriola Oyj regarding smoking cessation product Acetium® Lozenge. The product will be distributed in the pharmacies and other Oriola's distribution channels. In September we signed contract with Retail Partner ApS for the distribution of the smoking cessation product Acetium® lozenge in Denmark and Sweden. At the end of the 2018 we signed contracts for Acetium® lozenge distribution with MHD Pharma in Vietnam and UAB Osteca in Lithuania.
During the review period Biohit's distributor Biohit HealthCare (Hefei) Co. Ltd announced that it will make significant investment to expand its production capacity. According the latest estimate new capacity will be available until end of Q1/2020.
Biohit Healthcare (Hefei) Co. Ltd acquired from Biohit's main shareholder Osmo Suovaniemi and from his family 33.2% of total number of Biohit shares and 29.5% of the voting rights based on shares.
GastroPanel® market situation in China is strong and we expect demand to grow in coming years.
During 2018 we got positive study results of colorectal cancer screening tests in Brazil. The clinical state of migraine study was concluded at the end of June. However the results are not completed until end of H1/2019.
In the future we are selective regarding our investments on clinical studies and we shift our focus on commercialization of our excellent products.
During the first half of 2018, we elaborated the final results of an international study continued in Brazil since 2014, comparing the diagnostic tests for colorectal cancer (CRC) screening. The design of this study was similar as the comparison study published in 2015, where the sensitivity and specificity of Biohit ColonView®-FIT test (specific to
human blood) was compared with the conventional guaiac-based test in detection of fecal occult blood (FOB). ColonView®-FIT-test, which like all other equivalent tests on the market, is based on the invention made by Biohit Oyj's founder in the early 1980's, represents the top among the new generation immunochemical (FIT) tests. The research group at Barretos Cancer Hospital (BCH) together with the Biohit Clinical Research Department analysed the results and completed the scientific communication reporting the final results of this new comparison study. These results further confirm the results of the previously reported comparison study, and in fact, the difference in favor of Biohit's ColonView®-FIT test compared with the conventional guaiac-based FOB test is even more significant than in the previous study. ColonView®-FIT is both of its performance (sensitivity and specificity) and with regard to patient safety, at a completely different level as the conventional guaiac-FOB test, which has now been confirmed in two independent clinical studies.
As reported previously, the clinical part of the double-blind, randomized trial for migraine patients run with a substantial delay, was finally concluded during the first half of 2018. The checking and reporting of the results are completed until June 2019. To increase the cohort size of the migraine trial, the study was decided to be extended by including two additional centers from Estonia. Both centers agreed to enroll 80 new patients to the study, using the same study protocol as the 6 centers in Finland. Patient enrollment in Tartu progressed well, whereas in Tallin was delayed.
Randomized clinical trial on cluster headache was concluded during the 2018. The checking and reporting of the results are completed until June 2019 like in migraine study.
The previously completed and reported GastroPanel® studies of Biohit is complemented by a new study initiated in 2017, targeted to two specific high-risk groups of patients. These are patients with type 1 diabetes mellitus (DM1) and those with autoimmune thyroid disease (AITD), both known to have a markedly increased risk of contracting autoimmune atrophic gastritis (AG). This study is conducted at GastroCenter and Internal Medice Department (Oulu University Hospital), where all consenting DM1 and AITD patients will be selected among the patients attending the outpatient departments and subjected to GastroPanel® examination. All those with GastroPanel® result suggesting atrophic gastritis will be invited to gastroscopy to clarify eg. the prevalence of the major risk factor of gastric cancer, AG, in these high-risk patients. At this moment, more than 200 DM1/AITD patents have been enrolled, with their GastroPanel® samples delivered to analysis at Biohit laboratory.
In 2018, 65,198 new series B shares were subscribed under Biohit Oyj's I 2013 stock options. The share subscription price was EUR 2.2766 per share. During the review period, a total of EUR 148,429.78 of the subscriptions was recognised in Biohit Oyj's invested unrestricted equity fund.
Biohit Oyj publishes financial reviews twice per year. In 2019, the company will publish its interim report for January-June (H1) 2019 on Wednesday, 14 August 2019 at 9:30 am.
This new study had a similar design as the ColonView-FIT comparison study conducted in St. Petersburg and published in 2015. Also the results of the two studies are very similar, confirming the superior sensitivity of ColonView-FIT as compared with the traditional guaiac test (HemoccultSENSA). Interestingly, the difference between the two tests was even more striking in the Barretos study than in the first study.
Biohit's management team member Business Development Director Lea Paloheimo retired as planned 31st of January 2019.
International group of multidisciplinary experts from China, Italy, Estonia and Finland, wrote a comprehensive and critical review on advantages and limitations of the Helicobacter tests as screening tools of gastric cancer.
President & CEO Strategy and quality History Corporate governance Financial statements
The Annual General Meeting (AGM) held on 25 April 2018 decided in accordance with the proposal by the Board of Directors that no dividend would be paid for the financial period that ended on 31 December 2018.
The AGM decided that the Board of Directors would have five (5) members and selected the following Board members until the end of the next AGM: members Professor (h.c.) Osmo Suovaniemi, Professor Stina Syrjänen, Professor Matti Härkönen, Commercial Counsellor Eero Lehti and managing director Franco Aiolfi.
The AGM selected PricewaterhouseCoopers Oy, a firm of Authorised Public Accountants, to act as Biohit Oyj's auditor.
The Extraordinary General Meeting (EGM) of Biohit Oyj held on Thursday August 16, 2018 decided to accept the propose to increase the number of Board members. The number shall be six (6).
Shareholders of Biohit Oyj decided that Managing Director of Biohit HealthCare (Hefei) Co., Ltd Liu Feng is elected as new member until the end of the next Annual General Meeting on addition of the Board members, which were elected in Annual General Meeting.
Stina Syrjänen resigned from the Board of Directors on 16 October 2018.
The members of Biohit's Management Team are: CEO Semi Korpela, CFO Jukka Kainulainen, Production & Research and Development Director Minna Mäki, Sales and Marketing Director Ilari Patrakka and Quality and Regulatory Affairs Director Daniela Söderström.
The number of Biohit Oyj's shares is 14,952,041 (14,886,843), of which 2,975,500 (2,975,500) are Series A shares and 11,976,541 (11,911,343) are Series B shares. The Series B shares are quoted on NASDAQ Helsinki in the Small cap/Healthcare group under the code BIOBV.
Supposing that the market capitalisation for series A and B shares is equal, the total market capitalisation at the end of the period was EUR 44.3 million (EUR 56.1 million on 31 December 2017).
| 1–12/2018 | 1–12/2017 | |
|---|---|---|
| High (EUR) | 6.20 | 6.85 |
| Low (EUR) | 2.94 | 3.74 |
| Average (EUR) | 4.37 | 5.44 |
| End (EUR) | 2.96 | 3.77 |
| Turnover (EUR) | 37,690,324 | 17,264,322 |
| Turnover volume | 8,616,223 | 3,301,644 |
At the end of the reporting period on 31 December 2018, the company had 6,847 shareholders (6,660 on 31 December 2017). Private households held 63.3% (77.2%). companies 7.5% (19.1%) and public sector organisations 0.0% (0.0%). Foreign ownership or
nominee registrations accounted for 29.2% (3.6%) of shares.
Further information on the shares, major shareholders and management shareholdings is available on the company's website at www. biohithealthcare.com/investors.
The parent company's distributable funds (unrestricted equity) on 31 December 2018 are EUR 11,324,090.66 of which the period net loss is EUR 1,515,586.40. The Board of Directors proposes to the Annual General Meeting that no dividend be paid for the fiscal year.
Biohit's financial reporting and Annual General
Biohit Oyj's Annual General Meeting has been planned to be held at 5.00 pm on Wednesday 24 April 2019 in Helsinki. The Board of Directors will call the General Meeting at a later date.
Biohit Oyj publishes a separate corporate Governance statement on its website at the following adress: https://www.biohithealthcare.com/ en/biohits-corporate-governance-statements/.
Biohit Oyj Board of Directors
CONSOLIDATED FINANCIAL STATEMENTS * Consolidated comprehensive income statement and balance sheet
| 1 Jan – 31 Dec | 1 Jan – 31 Dec | ||
|---|---|---|---|
| € 1,000 | Note | 2018 | 2017 |
| Net sales | 3 | 9,931 | 8,979 |
| Change in inventories of finished and unfinished products | 147 | –133 | |
| Other operating income | 5 | 18 | 8,256 |
| Materials and services | 6 | –3,637 | –3,206 |
| Expenses arising from employment benefits | 7 | –3,333 | –3,442 |
| Other operating expenses | 8 | –3,283 | –2,706 |
| Share of the profit/loss of joint ventures | 9 | - | 198 |
| EBITDA | –157 | 7,946 | |
| Depreciation and amortization | 11, 15, 16 | –1,807 | –1,589 |
| Operating profit/loss | –1,965 | 6,356 | |
| Financial income | 12 | 153 | 143 |
| Financial expenses | 12 | –212 | –94 |
| Profit/loss before taxes | –2,024 | 6,405 | |
| Income taxes | 13 | –120 | –267 |
| Profit/loss for the financial period | –2,143 | 6,139 | |
| Other items of comprehensive income | |||
| Items that may later be reclassified through profit and loss | |||
| Translation differences | 0 | –49 | |
| Items that will not be classified through profit and loss | |||
| Changes in the fair value of equity instruments measured at fair value through other comprehensive income | 632 | –110 | |
| Total comprehensive income for the period | –1,512 | 5,980 | |
| Distribution of profit/loss for the financial period | |||
| To the owners of the parent company | –2,143 | 6,139 | |
| Total | –2,143 | 6,139 | |
| Distribution of comprehensive income for the financial period | |||
| To the owners of the parent company | –1,512 | 5,980 | |
| Total | –1,512 | 5,980 | |
| Earnings per share calculated from earnings attributable to the owners of the parent company | |||
| Undiluted earnings per share (EUR) | 14 | –0.14 | 0.42 |
| Diluted earnings per share (EUR) | –0.14 | 0.41 |
| € 1,000 | Note | 31 Dec 2018 | 31 Dec 2017 |
|---|---|---|---|
| ASSETS | |||
| Non-current assets | |||
| Intangible assets | 15 | 5,045 | 6,764 |
| Property, plant and equipment | 16 | 557 | 708 |
| Other non-current financial assets | 17.18 | 1 | 2 |
| Deferred tax assets | 19 | 54 | 67 |
| Total non-current assets | 5,657 | 7,541 | |
| Current assets | |||
| Inventories | 20 | 826 | 681 |
| Trade and other receivables | 17, 21 | 2,025 | 1,960 |
| Other current financial assets | 17, 18 | 8,003 | 7,375 |
| Cash and cash equivalents | 17, 18, 23 | 1,375 | 1,339 |
| Total current assets | 12,229 | 11,354 | |
| Total assets | 17,887 | 18,895 |

| € 1,000 | Note | 31 Dec 2018 | 31 Dec 2017 |
|---|---|---|---|
| SHAREHOLDERS' EQUITY AND LIABILITIES | |||
| Shareholders' equity | |||
| Share capital | 24 | 2,350 | 2,350 |
| Invested unrestricted equity fund | 24 | 4,925 | 4,777 |
| Translation differences | 24 | –143 | –143 |
| Retained earnings | 24 | 8,760 | 10,259 |
| Shareholders' equity attributable to shareholders of the parent company | 15,892 | 17,243 | |
| Total shareholders' equity | 15,892 | 17,243 | |
| Long-term liabilities | |||
| Deferred tax liabilities | 19 | 380 | 311 |
| Financial liabilities | 17, 18, 26 | 42 | 59 |
| Other liabilities | 17, 18, 27 | 4 | 4 |
| Total long-term liabilities | 425 | 374 | |
| Short-term liabilities | |||
| Trade payables | 17, 27 | 518 | 414 |
| Short-term interest-bearing liabilities | 17, 18, 26 | 17 | 17 |
| Tax liabilities | 17, 27 | 13 | 8 |
| Other liabilities | 17, 27 | 1,022 | 839 |
| Total short-term liabilities | 1,569 | 1,278 | |
| Total shareholders' equity and liabilities | 17,887 | 18,895 |
Statement of changes in consolidated shareholders' equity

| Shareholders' equity attributable to shareholders of the parent company | |||||||
|---|---|---|---|---|---|---|---|
| € 1,000 | Note | Share capital | Invested unrestricted equity fund |
Translation differences |
Fair value reserve |
Retained earnings |
Total shareholders' equity |
| Shareholders' equity 1 January 2018 | 2,350 | 4,777 | –143 | 914 | 9,345 | 17,243 | |
| Change in accounting policies | 24 | - | - | - | –41 | 33 | –7 |
| Adjusted shareholders' equity 1 January 2018 | 2,350 | 4,777 | –143 | 873 | 9,379 | 17,236 | |
| Incentive scheme for senior management | - | - | - | - | 20 | 20 | |
| Subscription of options | - | 148 | - | - | 148 | ||
| Total comprehensive income for the period | - | - | 0 | 632 | –2,143 | –1,512 | |
| Shareholders' equity 31 December 2018 | 2,350 | 4,925 | –143 | 1,505 | 7,255 | 15,892 |
| Shareholders' equity attributable to shareholders of the parent company | ||||||
|---|---|---|---|---|---|---|
| € 1,000 | Share capital | Invested unrestricted equity fund |
Translation differences |
Fair value reserve |
Retained earnings |
Total shareholders' equity |
| Shareholders' equity 1 January 2017 | 2,350 | 4,348 | –94 | 1,024 | 3,122 | 10,750 |
| Incentive scheme for senior management | - | - | - | - | 85 | 85 |
| Subscription of options | - | 429 | - | - | - | 429 |
| Total comprehensive income for the period | - | - | –49 | –110 | 6,139 | 5,980 |
| Shareholders' equity 31 December 2017 | 2,350 | 4,777 | –143 | 914 | 9,345 | 17,243 |
Consolidated cash flow statement

| €1,000 | Note | 2018 | 2017 |
|---|---|---|---|
| Cash flow from operating activities | |||
| Profit/loss for the financial period | –2,143 | 6,139 | |
| Adjustments to profit for the financial period | |||
| Business activities with no payment transactions | 26 | –6,757 | |
| Depreciation and impairment | 11 | 1,807 | 1,589 |
| Unrealised exchange rate gains and losses | 1 | ||
| Financial income and expenses | 59 | –40 | |
| Other adjustments | –1,744 | ||
| Income taxes | 13 | 120 | 267 |
| Total adjustments to income for the financial period | 22 | 2,012 | –6,684 |
| Change in working capital | |||
| Increase (-)/decrease (+) in short-term interest-free trade receivables | –54 | 12 | |
| Increase (-)/decrease (+) in inventories | –145 | 183 | |
| Increase (+)/decrease (-) in short-term interest-free liabilities | 264 | –495 | |
| Total change in working capital | 65 | –300 | |
| Interest paid | –68 | –40 | |
| Interest received | 132 | 131 | |
| Realised exchange rate gains and losses | –13 | –61 | |
| Income taxes paid | –78 | –127 | |
| Net cash flow from operating activities | –93 | –943 |
| Biohit in brief | Review by the |
|---|---|
| President & CFO |
President & CEO Strategy and quality History Corporate governance Financial statements
| €1,000 Note |
2018 | 2017 |
|---|---|---|
| Cash flow from investments | ||
| Investments in tangible and intangible assets | –13 | –170 |
| Income from disposal of tangible and intangible assets | –2 | - |
| Cash received from divestment of joint venture | - | 1,743 |
| Investments in funds and deposits | –2,112 | –877 |
| Profit from the sale of investments in funds and deposits | 2,131 | 500 |
| Net cash flow from investments | 4 | 1,196 |
| Cash flow from financing activities | ||
| Paid share issue | 148 | 429 |
| Withdrawal of loans | - | 88 |
| Payments for financial leasing liabilities | –17 | –13 |
| Net cash flow from financing activities | 131 | 504 |
| Change in financial assets | 43 | 757 |
| Cash and cash equivalents at the beginning of the period | 1,339 | 597 |
| Effect of changes in exchange rates | –7 | –15 |
| Cash and cash equivalents at the end of the period 23 |
1,375 | 1,339 |
Notes to the consolidated financial statements
Biohit Oyj is a Finnish public limited company that manufactures products that bind acetaldehyde, diagnostic products and systems for diagnostic analysis for the use of research institutions, healthcare and industry. The parent company's domicile is Helsinki, Finland.
A copy of the consolidated financial statements is available on the website, www.biohit.fi, and at the headquarters of the Group's parent company at Laippatie 1, Helsinki, Finland.
Biohit Oyj's Board of Directors approved the financial statements for publication on 20 February 2019. In accordance with the Finnish Limited Liability Companies Act, shareholders have the opportunity to approve or reject the financial statements at the Annual General Meeting, which is to be held after the financial statements have been published. At the Annual General Meeting, it is also possible for a decision to be made to alter the financial statements.
These financial statements have been prepared in accordance with the International Financial Reporting Standards (IFRS) endorsed by the
European Union. The IAS and IFRS standards that were valid on 31 December 2018 have been followed, as well as SIC and IFRIC interpretations. The IFRS refer to standards and interpretations thereof approved for application in the EU in compliance with the proceedings stipulated in Regulation (EC) 1606/2002, as referred to in the Finnish Accounting Act and subsequent regulations. The notes to the consolidated financial statements also comply with Finnish accounting and corporate legislation.
The consolidated financial statements have been prepared in compliance with the principle of operational continuity. Despite its loss-making financial periods, the company has succeeded in keeping its working capital at a good level and the company believes that it is sufficient to cover the next 12 months of operations. The company is not dependent on external financing to guarantee operational continuity. In the assessment of the company's senior management, the company's capacity to continue operating is good, and there are no foreseeable events or conditions that could occur individually or in combination to give major cause to doubt the company's ability to continue operating.
The consolidated financial statements have been prepared on the basis of acquisition cost with the exception of equity investments recognised at fair value through other comprehensive income and financial assets and liabilities recognised at fair value through profit or loss. The financial
statements are presented in thousands of euros. The figures presented in the financial statements are rounded from precise figures, so the combined total of individual figures may differ from the total sum presented. Indicators have been calculated using precise values.
The preparation of IFRS-compliant financial statements requires the Group management to make certain estimations and judgments when applying the Group's accounting policies. Information on judgements that the management has made when applying the Group's accounting principles and that have the most significant effect on the figures presented in the financial statements are presented under "Accounting policies calling for judgements by the management and key sources of estimation uncertainty".
The Group's income statement is presented as a single calculation in which the share of the income accounted for by the Group's ongoing operations is presented first and income due to discontinued operations is then presented on a single line.
The consolidated financial statements include the parent company, Biohit Oyj, and all of its subsidiaries. Subsidiaries are companies over which the Group exercises control. The Group has
a controlling interest in a company if, by being involved in the company, it is exposed to fluctuating returns or is entitled to such fluctuating returns and it is able to influence these returns by exercising its control over the company.
Mutual shareholdings of Group companies have been eliminated using the acquisition cost model. Acquisition costs include transferred assets at fair value, generated or assumed liabilities and equity-based instruments that are issued. Acquired subsidiaries are consolidated from the moment that the Group gains control over them and divested subsidiaries are consolidated until this control ends. All internal Group business transactions, receivables, liabilities, unrealised profits and internal profit distribution are eliminated when preparing the consolidated financial statements. Unrealised losses are not eliminated if the loss results from impairment. The distribution of profits for the financial period to the parent company's owners and minority interest-holders is presented in the income statement, and the minority interestholders' share of equity is presented as a separate item in the balance sheet under equity. The minority interest-holders' share of accumulated losses is recognised in the consolidated financial statements up to the amount of the investment. The Group has no associated companies or minority shareholders.
Subsidiaries are consolidated into the financial statements from the moment that the Group gains control over them until this control ends.
The consolidated financial statements have been prepared using the acquisition-cost method. The Group's share of assets, liabilities and contingent liabilities on the date of acquisition is recognised at fair value and the amount in excess of the fair-value acquisition cost is recognised as goodwill. If the acquisition cost of a subsidiary is less than the value of the net assets on the date of acquisition, the difference is recognised in the income statement. Internal Group business transactions, receivables, liabilities and unrealised profits from internal sales are eliminated in the consolidated financial statements. Unrealised losses are also eliminated unless an internal business transaction demonstrates that an asset has become impaired. The share of a subsidiary owned by minority interest-holders is presented in the consolidated balance sheet under equity, separately from shareholders' equity. The accounting principles applied by subsidiaries have been adapted to correspond to the Group's principles. On 31 December 2018, the company had no goodwill on its balance sheet.
The Group has applied IFRS 11 to all of its joint arrangements. Under IFRS 11, joint arrangements are classified as joint operations or joint ventures in accordance with the investors' contractual rights and obligations. The Group has assessed the nature of its joint arrangements and determined that they are joint ventures. Joint ventures are consolidated using the equity method. When the equity method
is used, shares in joint ventures are initially recognised at acquisition cost and this amount is increased or decreased by entering the Group's share of the subsequent profits or losses and other items of comprehensive income. If the Group's share of a loss made by a joint venture is as great as or greater than its interest in the joint venture (including any non-current receivables that actually constitute part of the Group's net investment in the joint venture), the Group will not recognise additional losses unless it has a legal or factual obligation to do so and it has not made payments on behalf of the joint venture. Business transactions between the Group and its joint arrangements give rise to unrealised profits, which are eliminated in accordance with the Group's ownership stake. Unrealised losses are also eliminated unless a business transaction indicates that the value of a transferred asset has become impaired. The joint arrangements were discontinued on 31 May 2017.
The profit and financial position of the Group's units are measured in the currency of the main operating region of the unit in question. The consolidated financial statements are presented in euro, which is the functional and presentation currency of the Group's parent company.
Foreign currency business transactions are recorded in the functional currency at the exchange rate on the date of transaction. Monetary receivables and liabilities are translated at the
exchange rate on the closing date of the financial period. Non-monetary foreign currency items have been translated into the functional currency at the exchange rates on the transaction date. Any exchange differences arising from translation are recognised in the income statement. Any exchange differences arising from the translation of accounts receivable and accounts payable within the Group are recognised as financial items, while corresponding external items are treated as sales or purchase adjustment items. The income statements of foreign subsidiaries have been translated into euro at the average exchange rate for the financial period and the balance sheets have been translated at the exchange rate on the closing date of the financial period. The exchange difference resulting from translating income statement items using the average exchange rate and balance sheet items at the exchange rate on the closing date of the financial period has been recognised as a separate item under translation differences in equity. Exchange differences from monetary items calculated as net investments made in foreign subsidiaries are recognised as translation differences.
Biohit's product portfolio consists of diagnostic tests, analysis systems, products that bind carcinogenic acetaldehyde into harmless compounds, monoclonal antibodies and service laboratory operations. The company classifies
its entire product and service portfolio into one segment.
Segment information is provided to the most senior operative decision-making body as part of internal reporting in a consistent manner. The Group's Management Team is the most senior operative decision-making body. It is responsible for allocating resources to business segments.
The Group has adopted IFRS 15 Revenue from contracts with customers from 1 January 2018. The new standard establishes a five-step model for recognizing revenue from contracts with customers, and it replaced IAS 18 and IAS 11 and the related interpretations.
In the implementation of IFRS 15, Biohit applied a modified retrospective approach, whereby the effect of contracts involving goods or services not yet transferred as of the date of the initial application, is recognised in retained earnings in the opening balance sheet at the date of initial application. As a result of the modified transition approach, comparative information was not adjusted. Before the implementation of the standard, Biohit estimated that the implementation may have an effect for contracts where revenue is expected to be recognised when the customer sells products for which Biohit earns a contractual royalty. The adoption of the standard did not affect Biohit's equity nor revenue recognition practices.
Revenue is recognised on a gross basis, as Biohit acts as a principal towards customers. The transaction price is estimated separately for each contract at the amount of consideration that Biohit is expected to be entitled to in exchange of the goods or services transferred. The determination of the transaction price is normally straightforward, as Biohit's contracts include no variable consideration such as retrospective discounts. Biohit applies the practical expedient and therefore does not recognise a significant financing component, i.e. does not adjust the promised consideration for time value of money when the time between the delivery of the promised good or service to the customer and the payment by the customer is less than one year.
Some distribution agreements include the right to return the goods. In this case, Biohit recognises revenue at the amount that it expects to be entitled to, and recognises a refund liability within advance payments (Note 27) as well as an asset reflecting the right to the returned goods in tangible assets in the balance sheet (Note 20). At the end of each reporting period, Biohit updates its estimates relating to the sales involving a right to return and adjusts revenue, cost of goods sold and the related refund liability and asset accordingly.
Revenue for each good or service as well as royalty from license-based business is recognised as a distinct performance obligation, as those are separately identifiable and Biohit's customers can benefit from them individually. Revenue from goods sold is recognised at a point of time when control over them is transferred to the customer in accordance with the commercial terms of delivery, i.e. when the goods leave the warehouse
Review by the President & CEO Strategy and quality History Corporate governance Financial statements
in accordance with "ex-works". For laboratory services, Biohit considers that control is transferred to the customer when the results of an analysis are delivered to the customer, and revenue is recognised at a point of time. Revenue from licencebased contracts is recognised based on a so-called subsequent sale, i.e. on the basis of revenue generated from the sales of the licenced goods by the customer or on the basis of the number of goods sold. Where Biohit is unable to receive from the customer the information regarding the amount of sales or the number of goods sold that forms the basis for royalty income, royalty income is estimated based on historical data. In the financial year 2018, royalty income is based on information submitted by the customers.
Biohit has a contractual obligation to withdraw defective goods from the market and replace them with new products without a separate compensation. Costs relating to the withdrawal are accounted for in accordance with IAS 37 Provisions, contingent liabilities and contingent assets. The amount of costs relating to goods withdrawn has not been material in Biohit's business.
Biohit recognises a contract asset when the right to a consideration is not unconditional. The asset is recognised within sales receivables when the right to a consideration is unconditional, i.e. when only passage of time is required before payment of the consideration is due. A contract liability is recognised for payments received from customers
for which no goods or services have yet been delivered by Biohit.
Biohit has not incurred any significant costs to obtain the contracts, such as sales commissions. Biohit applies a practical expedient and recognises the incremental costs of obtaining a contract as an expense as incurred, if the amortisation period for the related asset would be one year or less.
Biohit applies the practical expedient and does not disclose information about partly or completely unsatisfied performance obligations that relate to contracts with a duration one year or less. Biohit's contracts with a duration of more than one year consist of distribution agreements that are framework contracts by nature and do not meet the criteria in IFRS 15 for the existence of a contract without specific purchase orders for quantities to be delivered. In this case, future sales relating to distribution agreements are not accounted for as unsatisfied performance obligations, and no transaction price is allocated to them.
Biohit uses management's estimates when recognising revenue from contracts with customers including a right of return. Management estimates the extent to which the right of return will be exercised, and revenue is recognised only for the products which, according to management's estimate, are very likely not to be returned. Management's estimates are based on historical
return rates or, where historical data is not available, on estimates regarding future returns based on unsold goods included in the customer's inventory and their expiry dates.
Revenue from sales of goods and services is recognised, when the related material risks and benefits have been transferred to the purchaser and there is no significant uncertainty regarding payment or cost or any return of goods. The amount of revenue to be recognised consists of the fair value of the consideration to be received for the good or service, less sales tax and volume and other discounts, and adjusted for foreign exchange gains or losses relating to sales.
The goods sold by the Group comprise diagnostic tests, products that bind acetaldehyde, analysis systems and monoclonal antibodies. The sale of goods is recognised when the goods have been delivered to the customer and the risk relating to the goods has been transferred to the customer. Services sold by the Group comprise analysis of samples in the service laboratory. Revenue from services is recognised when the samples have been analysed. Consolidated net sales include contractual royalties whereby Biohit receives a proportion of the sales made by a contractual partner. Royalties are recognised as net sales on an accrual basis in accordance with the contents of the related contracts. Royalties are recognises as
President & CEO Strategy and quality History Corporate governance Financial statements
income when the income can be determined reliably and the economic benefits related to the transaction are likely to flow to the Group.
Property, plant and equipment are recognised at original acquisition cost, less accumulated depreciation and impairments. Acquisition cost includes the direct costs arising from acquisition. Costs that arise subsequently are included in the book value of the asset or recognised as separate assets only if it is likely that the future financial benefit associated with the asset will benefit the Group and the acquisition cost of the asset can be reliably determined. Other repair and maintenance costs are recognised through profit or loss in the period during which they have materialised.
Straight-line depreciation is applied to assets according to the estimated useful life. No depreciation is made on land.
The estimated useful lives are as follows: Machinery and equipment: 3–10 years
The residual value and the useful life of assets are checked in every financial statement and, if necessary, adjusted to represent changes that have occurred in the expectations of financial benefit. Sales gains and losses accumulated from the disposal or transfer of tangible fixed assets are included in other operating income or expenses.
Research expenditure is recognised as an expense in the balance sheet. Development expenditure related to designing new and more advanced products is capitalised in the balance sheet as an intangible asset when the product can be technically realised and commercially exploited, and the product is expected to generate a future financial benefit. Development expenditure that has previously been recognised as an expense cannot be capitalised at a later date. Depreciation is booked for an asset from the time it is ready for use. No development expenditure was capitalised on the balance sheet on 31 December 2018.
Intangible assets are only entered in the balance sheet if the acquisition cost of the asset can be reliably determined and if it is likely that the expected financial benefit from the asset will benefit the company. Other intangible assets with a limited useful life are entered in the balance sheet at original acquisition cost, and costs are booked in the income statement based on straightline depreciation over the course of the known or estimated useful life of the asset. The Group has no intangible assets with indefinite useful lives.
The depreciation periods are as follows:
| Patents: | 4–10 years |
|---|---|
| IT software: | 3 years |
| Other intangible assets: | 5–10 years |
On the closing day of each financial period, the Group assesses whether there are indications of impairment in the value of a particular asset. If there are such indications, the recoverable amount from the said asset is estimated. Additionally, the recoverable amount is estimated annually for goodwill, regardless of whether there is any indication of impairment. The need for impairment is reviewed at the level of cash-generating units, that is, the lowest unit level that is largely independent of other units, and whose cash flow can be separated from other cash flows. The discount rate used is the interest rate that is determined before taxes and that describes the market's view of the time value of money and the risks incorporated in the tested asset.
The recoverable amount is the asset's fair value, less costs arising from transfer or a higher utility value. Value in use is the estimated future net cash flow from the asset or cash-generating unit, which is discounted to its present value. Impairment loss is recognised if the book value of the asset is higher than the recoverable amount. Impairment loss is recognised immediately in the income statement. If the impairment loss is allocated to a cash-generating unit, it is first allocated to reduce the goodwill of the cash-generating unit and then to reduce the other assets of the unit pro rata. The impairment loss is cancelled if there is a change in the conditions and the recoverable amount from the asset has changed since the impairment loss was booked. However, the impairment loss may not be reversed in excess of what the asset's book value
would be without the recognition of the impairment loss. Impairment losses recognised for goodwill are never reversed.
Inventories are measured at acquisition cost or net realisable value, whichever is lower. The acquisition cost is determined using the FIFO method. The acquisition cost for finished and unfinished products consists of raw materials, direct labour costs, other direct costs, and the appropriate share of manufacturing-related variable overheads and fixed overheads at a normal level of operations. The net realisable value is the estimated selling price in the ordinary course of business, less the estimated costs for completing the product and costs related to sales.
In Group companies, pension cover is arranged in accordance with the pension legislation and practices of the country in question. The pension arrangements are defined-contribution plans. The payments related to defined-contribution pension plans are recognised as costs in the financial period in which they arise.
The Group has incentive plans where payments are made in the form of equity instruments. The benefits granted under the plans are recognised at fair value on the date on which they were granted
and entered as costs evenly throughout the period during which they were earned. The effect of the plans on profit or loss is presented under costs of employee benefits.
The cost determined on the date on which the options were granted is based on the Group's estimate of the number of options for which rights are presumed to arise at the end of the incentiveearning period. The Group updates the presumption of the final number of options on the final day of every reporting period. Changes in estimates are treated through profit or loss. The fair value of option plans is defined on the basis of the Black-Scholes option pricing model. Terms that are not market-based, such as profitability and specific growth targets, are not taken into consideration when determining the fair value of options. Instead, they affect the estimate of the final number of options.
When option rights are exercised, the assets obtained from share subscriptions are entered into the invested unrestricted equity fund in accordance with the terms of the plan.
A provision is entered when the Group has, due to a past event, a legal or factual obligation, and the obligation is likely to materialise and the sum of the obligation can be reliably estimated. The amount to be recognised as a provision corresponds to the best estimate of the costs required to meet existing obligations on the closing date of the financial
period. If the time value of money has a material impact, the amount of the provision is recognised as the present value of anticipated expenses.
The tax expense in the income statement consists of the current tax expense and deferred tax. The amount of tax based on the taxable profit for the period is calculated from the taxable profit based on the applicable tax rate in each country. The tax is adjusted by possible taxes related to previous periods.
Deferred taxes are calculated from all temporary differences between the book value and tax base. The biggest temporary differences arise from the depreciation of property, plant and equipment, deferred tax assets and internal margins on inventory.
No deferred tax is recognised for non-deductible goodwill impairment or for the undistributed profits of subsidiaries if the temporary difference is not likely to dissolve in the foreseeable future.
Deferred tax is calculated using the tax rates enacted by the balance sheet date. Deferred tax assets are recognised to the amount for which it is likely that taxable profit will be generated in the future against which the temporary difference can be utilised.
President & CEO Strategy and quality History Corporate governance Financial statements
The group applies IFRS 9 standard for the first time for the financial year starting 1 January 2018. The group applies the new rules retrospectively but the comparatives are not restated. IFRS 9 addresses the classification, measurement, recognition and derecognition of financial assets and financial liabilities, introduces new rules for hedge accounting and a new impairment model for financial assets. The comparative financial information has been prepared according to IAS 39 Financial instruments: Recognition and Measurement.
Group's financial assets are classified in the following measurement categories: amortized cost, fair value through other comprehensive income and fair value through profit or loss. The classification depends on used business model for managing the financial assets and the contractual terms of the cash flows. Assets are classified as current assets, except for maturities over 12 months after balance sheet date, which are classified as non current assets. Purchases and sales of financial assets are recognized on the settlement date. Financial assets are derecognized when the rights to receive cash flows from the investments have expired or have been transferred and the Group has transferred substantially all risks and rewards of ownership.
Amortized cost category consist of cash and cash equivalents, trade receivables and loan receivables where the business model is to hold the asset to collect the contractual cash flows. Financial assets recognized at amortized cost are valued using the effective interest method. In year 2017 these items were classified as loans and receivables when applying IAS 39 for the comparable period.
Assets at fair value through profit or loss consist of interest or equity funds or investments into listed bonds. All gains or losses of fair value changes investments in the category is included in financial income and expenses. Equity investments and investment in funds were classified as available for sale -category when applying IAS 39 for the comparable period.
comprehensive income consist from equity investments to unlisted Genetic Analysis AS shares. These shares were reported as available for sale during comparative reporting period. The group hold these shares as long-term strategic investments which are not expected to be sold at short or medium term period. All fair value changes in this category are recognised in equity and any potential future gain or loss from sale of assets will lead to transfer between equity to retained earnings without impact to the profit and loss statement. Dividends from equity investments are recognized at profit and loss statement.
Group's financial liabilities are classified as amortized cost and measured at fair value net of transaction cost at settlement date. Financial liabilities are subsequently measured at amortized cost using the effective interest method. Financial liabilities at amortized cost consist from loans from financial institutions, bank overdrafts and from other financial liabilities. Financial liabilities are included in non-current liabilities, except for items with maturities less than 12 months after the balance sheet date, which are included in current liabilities. A financial liability is derecognized when the related obligation is discharged, cancelled or expires. The group does not have any derivative liabilities.
The fair values of other interest-bearing liabilities at amortized cost are determined by using the discounted cash flow method employing market interest rates at the balance sheet date.
The credit loss is recognized based on individual assessment of receivable. The simplified expected credit loss model is applied for trade receivables. The impairment process is based on historical credit loss experience combined with current conditions and forward looking macroeconomic analysis. The impairment or credit loss is recognized in the consolidated statement of income within other expenses. In 2017 the provision for impairment was recognized for receivables over 90 days overdue. Maturity analyses for trade receivables, movement
Review by the President & CEO Strategy and quality History Corporate governance Financial statements
in allowance account and general provisioning matrix is presented at note 28 under section credit risk. The Other financial assets at amortized cost consist from cash at banks. The impairment has not been recognised from these assets, as the impact is immaterial to the group's figures due the low credit risk.
IAS 1 Presentation of Financial Statements does not define the concept of operating profit. The Group has defined it as follows: operating profit or loss is a net total that can be calculated by adding other operating income to net sales, subtracting purchase expenses adjusted by the change in the stock of finished and unfinished products as well as expenses caused by production for own use, subtracting expenses from employee benefits, depreciation and potential impairment losses, as well as other operating expenses. All other items, including discontinued operations, are presented beneath operating profit or loss. Exchange differences and changes in the fair value of derivatives are included in operating profit or loss providing they arise from business-related items. Otherwise, they are recognised as financial items. Exchange differences related to the Group's internal receivables and liabilities are recognised as financial items.
When preparing the financial statements, the management must make assessments and assumptions concerning the future, and the outcome may deviate considerably from the original assessments and assumptions. In addition, discretion must be used in applying the accounting policies. Although the estimates are based on the most recent information available, the realised values may differ from these estimates. The most important areas in which estimates and discretion are used are described below.
The Group conducts impairment tests as required on unfinished intangible assets. It also assesses any indication of impairment in accordance with the aforementioned accounting policies. The recoverable amounts of cash-generating units are measured on the basis of value-in-use calculations. Preparing these calculations requires the use of estimates.
Deferred tax assets for unused tax losses and temporary differences in regard to recognised deferred tax assets are estimated by the Group at least once per year to determined the likelihood of the company in question generating sufficient taxable income before the unused tax losses expire.
Insofar as quoted valuations cannot be obtained from securities markets for liquid assets measured at fair value through other comprehensive income, the fair values are based on data that can be obtained for the assets or liabilities in question either directly (as a price) or indirectly (as a derivative of the price). The Group uses generally accepted valuation models to determine the fair values of these instruments, and the input data for these models are based in significant part on observable market data. For the valuation of Genetic Analysis AS, the input data consists of transactions involving the company's shares on market terms between third parties. The company classifies the shares in Genetic Analysis AS as equity investments recognised at fair value fair value through other comprehensive income. On the balance sheet date, the fair value of the shares was EUR 3.9 million.
Biohit will begin applying new or amended IFRS standards and interpretations as of the date on which they enter into force or when they are approved for adoption in the EU. The consolidated financial statements were prepared in compliance with the same principles used in 2017, except for IFRS 15 and IFRS 9, which were adopted on 1 January 2018. See the sections "Revenue recognition" and "IFRS 9 Financial Instruments" in the accounting principles.
Biohit has not yet applied the following new and amended standards and interpretations, which have already been published but have not been approved by the European Union or will not take effect until after the financial period. The Group intends to apply these on the date on which they enter into force or from the beginning of the following financial period if this date is not the first day of the financial period.
The International Accounting Standards Board has published a new standard: IFRS 16 Leases. The standard must be applied as of 1 January 2019.
Biohit applies IFRS 16 for the first time for the reporting period beginning on 1 January 2019. It will result in almost all leases being recognised on the balance sheet by lessees as the distinction between operating and finance leases is removed. Under the new standard, lessee recognises a rightof-use asset (the right to use the leased item) and a lease liability to pay rentals. The standard includes optional recognition exemptions for short-term leases (12 months or less) and leases for which the underlying asset is of low value. Biohit has prepared an analysis for IFRS 16 impacts on the financial statements. Due to adopting IFRS 16 standard, the opening balance sheet on January 1 2019 will increase by EUR 0.3 million. Biohit has evaluated that the most significant impact of adopting the standard is that Biohit recognises new liabilities and right-of-use assets, relating to office premises
and company cars from lease contracts currently classified as operating leases. Furthermore, the nature of expenses relating to such lease contracts changes when the rent expense is removed and depreciation of the right-of-use asset and interest expense (included in financial expenses) on the lease liability will be recognised. Biohit applies the simplified transition method and does not restate comparative amounts for the year prior to first adoption. Instead, the cumulative effect of applying the standard is recognized as an adjustment to the opening balance of retained earnings at the date of initial application.
President & CEO Strategy and quality History Corporate governance Financial statements
The company's product portfolio consists of diagnostic tests, products that bind acetaldehyde and monoclonal antibodies.
The company classifies its entire product portfolio into one segment.
| NET SALES BY MARKET AREA (EUR THOUSAND) | 2018 | 2017 |
|---|---|---|
| Finland | 438 | 390 |
| Europe, other | 3,648 | 3,035 |
| North and South America | 164 | 223 |
| Asia | 4,689 | 4,562 |
| Other countries | 992 | 769 |
| Net Sales from contracts with customers total | 9,931 | 8,979 |
The majority of Biohit's net sales is generated from the diagnostic products. In the year 2017 India was part of the other countries in 2018 part of the Asia.
The majority of Biohit's net sales is generated from distributor agreements. Biohit's customers, i.e. the distributors, buy and resell the products. Biohit has no post-sales rights or obligations relating to the control over the products, except for a right of return relating to some distribution agreements. The goods that are sold include several various tests for diagnostics of diseases in the gastrointestinal tract, such as celiac quick test, lactose intolerance test, Vitamin D test, GastroPanel® test for the first-line diagnosis of dyspepsia measured on simple blood test. Furthermore, the product portfolio includes Acetium® lozenge and Acetium® capsule, which are acetaldehyde-binding products sold under the trade mark Acetium.
In licencing agreements, Biohit transfers licensed immaterial rights to a customer, and the customer both produces and sells the products. Licencing agreements cover both diagnostic products and Acetium products.
Biohit also has contracts that include both a distribution agreement and a licensing agreement. In this case, Biohit sells to the customer finished products and raw materials needed for production and, in addition, receives a royalty fee based on the sale of the product. Revenue from the sale of finished products, raw materials and royalty income from licences are recognised as separate performance obligations.
Biohit provides laboratory services, such as GastroPanel® tests, for customers. Biohit analyses the sample collected from the customer and delivers the results of the analysis to the customer or to a company. The proportion of service contracts of Biohit's net sales is insignificant.
Biohit recognises revenue at a point of time when goods and services are delivered. The payment terms in Biohit's contracts with customers vary from a payment to be made one month in advance to payment in 60 days.
A contract liability is recognised for payments received where the goods or services have not yet been delivered. This is the case, among others, with countries outside Europe and Asia, where as a result of a higher credit risk relating to customers, an advance payment is received, on the average, one month before the delivery of the goods. The timing difference between the receipt of the advance payment by Biohit and the delivery of the products or the results of a service does not exceed one year.
| € 1,000 | 31 Dec 2018 | 1 Jan 2018 |
|---|---|---|
| Contract Assets | 27 | 8 |
| Trade receivables | 1,655 | 1,617 |
| Contract assets and receivables total | 1,681 | 1,626 |
| € 1,000 | 31 Dec 2018 | 1 Jan 2018 |
| Contract liabilities | 12 | 0 |
| Contract liabilities total | 12 | 0 |
The items included in contract liabilities at the beginning of the period have been recognised as revenue during the financial year.
No businesses were acquired in the 2017 and 2018 financial periods.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Biohit Healthcare (Hefei) Co. Ltd, capital gain * | - | 8,200 |
| Subsidies | 17 | 39 |
| Loss from sales of property, plant and equipment | –2 | –6 |
| Others | 3 | 23 |
| Total | 18 | 8,256 |
* On 2 January 2017, Biohit Oyj announced an arrangement to reduce the share capital in Biohit HealthCare (Hefei) Co. Ltd, a joint venture operating in Hefei, China, leading to Biohit Oyj giving up its holding in the company. In H1/2017, the transaction was granted the requisite approval by the authorities and the share capital in the joint venture was reduced by an amount corresponding to Biohit Oyj's holding. A capital gain amounting to approximately EUR 8.4 million was recognised during the first half of the 2017 financial period, and this affected the comparability of the operating profit. The amount recognised under intangible rights on the balance sheet was approximately EUR 7.1 million. In addition, a proportion of the transaction was paid in cash in the amount of EUR 1.7 million. After direct taxes and exchange rate fluctuations, the net effect was approximately EUR 1.5 million. Biohit HealthCare (Hefei) Co. Ltd is no longer a joint venture of Biohit Oyj, nor has it been included in the consolidated balance sheet as of 1 June 2017.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Materials, supplies and goods | 2,867 | 2,741 |
| External manufacturing services | 770 | 465 |
| Total | 3,637 | 3,206 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Salaries | 2,842 | 2,860 |
| Pension expenses – defined-contribution plans | 412 | 421 |
| Options and share bonuses realised and paid in | ||
| shares | 20 | 85 |
| Other personnel expenses | 59 | 75 |
| Total | 3,333 | 3,442 |
| period | 2018 | 2017 |
|---|---|---|
| Group total | 50 | 51 |
Details of the employment benefits enjoyed by senior managers are presented in note 29 ("related-party transactions").
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Travel expenses and other personnel expenses | 379 | 336 |
| Rents and maintenance expenses | 384 | 387 |
| Sales and marketing expenses | 932 | 454 |
| Other external services | 1,189 | 1,138 |
| Other operating expenses | 399 | 390 |
| Total | 3,283 | 2,706 |
Other operating expenses include research and development expenses of EUR 1,290 thousand (EUR 1,211 thousand).
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Consolidation of the profit form Biohit HealthCare | ||
| (Hefei) Co. Ltd in the financial period * | - | 198 |
* See note 5
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Companies belonging to the PricewaterhouseCoopers chain |
||
| Auditors' fees | 100 | 63 |
| Auditors' statements | 10 | 6 |
| Tax service | - | 8 |
| Other services | 14 | 22 |
| Total fees paid to the auditor | 124 | 99 |
In the 2018 financial period, PricewaterhouseCoopers Oy provided Biohit Group with services unrelated to auditing at a total cost of EUR 14 thousand (2017: EUR 22 thousand).
These other services included expert services related to amending the articles of association and the effects of adopting IFRS 16.
President & CEO Strategy and quality History Corporate governance Financial statements
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Intangible assets | 1,643 | 1,002 |
| Buildings | - | 4 |
| Plant and equipment | 164 | 175 |
| Impairment depreciation | - | 409 |
| Total | 1,807 | 1,589 |
Impairment depreciation in 2017 consisted of the impairment of intangible rights that the company received as part of the sale of its holding in Biohit HealthCare (Hefei) Co. Ltd in a total amount of EUR 153 thousand and writedowns on customer relationships in Italy in an amount of EUR 256 thousand.
In the 2018 financial statements, the balance sheet value of patents related to the 2017 sale of Biohit HealthCare (Hefei) Co. Ltd was EUR 4.6 million. The patents will be subject to straight-line depreciation until the end of 2021. Impairment testing will be performed on the value of patents whenever there is an indication of impairment. An impairment test was conducted in conjunction with the 2018 financial statements. No impairment was recognised based on the impairment test. There is uncertainty concerning the future cash flows used for impairment testing as illustrated by the sensitivity analysis below for three factors:
| € 1,000 | 2018 |
|---|---|
| WACC (%) increased by 1% and impact on the value of patents | –60 |
| WACC (%) increased by 5% and impact on the value of patents | –300 |
The required return on capital depends on the interest environment and the risk level of equities.
| One-year delay to the initiation of production in China and impact on the value of patents |
–500 |
|---|---|
| Two-year delay to the initiation of production in China and impact on the value of patents |
–1 700 |
Royalty-based cash flow is dependent on the readiness of Biohit HealthCare (Hefei) Co. Ltd's production facilities in terms of sufficient production quality and ready production capacity. According to the latest estimate, the expanded production capacity will become available by the end of Q1/2020 when the distributor has received all of the permits from the authorities to allow production to begin.
| Decrease in demand for GastroPanel® by 20% and impact on the value of patents |
–100 |
|---|---|
| Decrease in demand for GastroPanel® by 40% and impact on the value of patents |
–1 200 |
Royalty-based cash flow is dependent on the growth of the Chinese market, successful sales work by the distributor and building up the brand.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Financial income | ||
| Net profit on investments recognised at fair value through profit or loss |
153 | 143 |
| Total | 153 | 143 |
| Financial expenses | ||
| Interest expenses on financial liabilities | –3 | –6 |
| Net loss on investments recognised at fair value through profit or loss |
–184 | - |
| Exchange rate losses from financial assets and liabilities |
- | –70 |
| Other financial expenses | –25 | –18 |
| Total | –212 | –94 |
| Total financial income and expenses | –59 | 49 |
In the 2017 financial statements, the item for financial income and expenses was classified in a different manner. The break-down reclassifies the figures for the comparison period so they correspond to the figures for 2018.
| Direct taxes | ||
|---|---|---|
| € 1,000 | 2018 | 2017 |
| Tax based on taxable income for the financial period | –104 | –267 |
| Deferred taxes | –16 | 0 |
| Total direct taxes | –120 | –267 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Profit before taxes | –2,024 | 6,405 |
| Taxes calculated at domestic rates 20% | 405 | –1,281 |
| Effect of differing tax bases applying to foreign subsidiaries |
–104 | –65 |
| Tax-free income and non-deductible expenses | –30 | 1,759 |
| Non-recognised deferred tax assets from taxable loss | –375 | –478 |
| Other items | –16 | –201 |
| Taxes on the income statement | –120 | –267 |
Undiluted earnings per share are calculated by dividing the profit attributable to shareholders of the parent company in the financial period by the weighted average number of shares in circulation during the financial period.
| 2018 | 2017 | |
|---|---|---|
| Profit for the period attributable to the owners of the parent company |
||
| (EUR thousand) | –2 143 | 6 139 |
| Average number of shares, undiluted | 14,901,904 | 14,764,411 |
| Effect of share options | 113,552 | 178,750 |
| Average number of shares, diluted | 15,015,456 | 14,943,161 |
| Earnings per share, undiluted (EUR) | –0.14 | 0.42 |
| Earnings per share, diluted (EUR) | –0.14 | 0.41 |
| Intangible | Other intan - |
||
|---|---|---|---|
| € 1,000 | rights | gible assets | Total |
| Acquisition cost 1 January 2018 | 9,062 | 712 | 9,774 |
| Decreases | –76 | - | –76 |
| Acquisition cost 31 December 2018 | 8,986 | 712 | 9,698 |
| Accumulated depreciation and impairment 1 January 2018 |
–2,300 | –711 | –3,011 |
| Depreciation | –1,641 | –2 | –1,643 |
| Accumulated depreciation and impairment 31 December 2018 |
–3,941 | –712 | –4,653 |
| Book value 1 January 2018 | 6,762 | 2 | 6,764 |
| Book value 31 December 2018 | 5,045 | - | 5,045 |
| Intan | Other intan - |
||
|---|---|---|---|
| € 1,000 | gible rights | gible assets | Total |
| Acquisition cost 1 January 2017 | 2,084 | 712 | 2,796 |
| Increases | 7,053 | - | 7,053 |
| Decreases | –75 | - | –75 |
| Acquisition cost 31 December 2017 | 9,062 | 712 | 9,774 |
| Accumulated depreciation and impairment 1 January 2017 |
–892 | –708 | –1,600 |
| Depreciation | –999 | –3 | –1,002 |
| Impairment | –409 | - | - |
| Accumulated depreciation and impairment 31 December 2017 |
–2,300 | –711 | –3,011 |
| Book value 1 January 2017 | 1,394 | 2 | 1,396 |
| Book value 31 December 2017 | 6,762 | 2 | 6,764 |
Intangible rights consist of patents.
2018
| € 1,000 | Plant and equipment |
Total |
|---|---|---|
| Acquisition cost 1 January 2018 | 1,752 | 1,752 |
| Increases | 35 | 35 |
| Decreases | –83 | –83 |
| Acquisition cost 31 December 2018 | 1,704 | 1,704 |
| Accumulated depreciation and impairment 1 January 2018 Depreciation Depreciation of decreases |
–1,044 –165 61 |
–1,044 –165 61 |
| Accumulated depreciation and impairment 31 December 2018 |
–1,147 | –1,147 |
| Book value 1 January 2018 | 708 | 708 |
| Book value 31 December 2018 | 557 | 557 |
| Plant and | ||
|---|---|---|
| € 1,000 | equipment | Total |
| Acquisition cost 1 January 2017 | 1,600 | 1,600 |
| Increases | 180 | 180 |
| Decreases | –28 | –28 |
| Acquisition cost 31 December 2017 | 1,752 | 1,752 |
| Accumulated depreciation and | ||
| impairment 1 January 2017 | –888 | –888 |
| Depreciation | –175 | –175 |
| Depreciation of decreases | 18 | 18 |
| Accumulated depreciation and impairment 31 December 2017 |
–1,044 | –1,044 |
| Book value 1 January 2017 | 712 | 712 |
| Book value 31 December 2017 | 708 | 708 |
| The Group categorised its financial assets and liabilities into the following categories on 31 December 2018: |
Amortized cost € 1,000 |
Fair value through profit and loss € 1,000 |
Fair value trough OCI € 1,000 |
Hierarchical level |
|---|---|---|---|---|
| Non-current assets | ||||
| Other non-current financial assets | 1 | Level 2 | ||
| Current assets | ||||
| Other current financial assets | 4,141 | Level 2 | ||
| Other current financial assets | 3,862 | Level 3 | ||
| Trade receivables | 1,655 | |||
| Other receivables | 371 | |||
| Cash and cash equivalents | 1,375 |
The company has classified the hierarchies of financial assets according to the availability of data on market terms and other price data.
The fair values on level 1 of the hierarchy are based on the quoted (unadjusted) prices of identical assets or liabilities on active markets. The group has mainly used valuations provided by its asset management partner as a source of price data for determining the fair value of these instruments, and the company has verified that the price data represents genuine, frequent market transactions involving the instruments in question.
In significant part, the fair values of level 2 instruments are based on other input data than the quoted prices included in level 1, although this data can be obtained for the assets or liabilities in question either directly (as a price) or indirectly (as a derivative of the price). The Group uses generally accepted valuation models to determine the fair values of these instruments, and the input data for these models are based in significant part on observable market data.
The level in the fair value hierarchy at which a certain item measured at fair value is classified overall is determined on the basis of the significant input data on the lowest level with regard to the entire item measured at fair value. The significance of input data is evaluated in its entirety in relation to the item valued at fair value.
The original book value of other receivables corresponds to their fair value because the effect of discounting is negligible in view of the maturity of the receivables.
President & CEO Strategy and quality History Corporate governance Financial statements

| IAS 39 | Carrying amount | Carrying amount | |||
|---|---|---|---|---|---|
| Financial Instruments reclassification followed by IFRS 9 adoption | Measurement | IFRS 9 Measurement Category |
(EUR 1,000) IAS 39 |
(EUR 1,000) IFRS 9 |
|
| Category | Change | ||||
| Current assets | |||||
| Investments | Fair value through profit | ||||
| Other current financial assets | available for sale | and loss | 4,302 | 4,302 | |
| Investments | Fair value through other | ||||
| Other current financial assets | available for sale | comprehensive income | 3,072 | 3,072 | |
| Trade receivables | Loans and other receivables |
Amortised cost | 1,617 | 1,617 | –0.0 |
| Other receivables | Loans and other receivables |
Amortised cost | 342 | 342 | |
| Cash and cash equivalents | Loans and other receivables |
Amortised cost | 1,339 | 1,339 | |
| Balance sheet values of financial assets by category 31 December 2017 | Financial securities | ||||
|---|---|---|---|---|---|
| Loans and other | measured via the fair | Fair value | |||
| € 1,000 | receivables | value reserve | Total book value | Fair value | hierarchy |
| Non-current financial assets | |||||
| Other non-current financial assets | 2 | - | 2 | 2 | 2 |
| Total | 2 | - | 2 | 2 | |
| Current financial assets | |||||
| Trade and other receivables | 1,960 | - | 1,960 | 1,960 | |
| Other current financial assets | - | 4,302 | 4,302 | 4,302 | 2 |
| Other current financial assets | - | 3,072 | 3,072 | 3,072 | 2 |
| Cash and cash equivalents | 1,339 | - | 1,339 | 1,339 | |
| Total | 3,299 | 7,375 | 10,674 | 10,674 | |
| Total financial assets | 3,301 | 7,375 | 10,676 | 10,676 |


| Financial liabilities by category | ||||
|---|---|---|---|---|
| Book value | Fair value | Book value | Fair value | |
| € 1,000 | 2018 | 2018 | 2017 | 2017 |
| Long-term financial liabilities valued at amortised cost | ||||
| Other liabilities | 4 | 4 | 4 | 4 |
| Financial leasing liabilities | 42 | 42 | 59 | 59 |
| Total | 46 | 46 | 63 | 63 |
| Short-term financial liabilities valued at amortised cost | ||||
| Trade payables | 518 | 518 | 414 | 414 |
| Tax liabilities | 13 | 13 | 8 | 8 |
| Other liabilities | 1,022 | 1,022 | 839 | 839 |
| Principal payments for financial leasing liabilities | 17 | 17 | 17 | 17 |
| Total | 1,569 | 1,569 | 1,278 | 1,278 |
| Total financial liabilities | 1,615 | 1,615 | 1,341 | 1,341 |
The original book value of accounts payable and other interest-free liabilities corresponds to their fair value because the effect of discounting is negligible in view of the maturity of the liabilities.
| 2018 | 2017 | |
|---|---|---|
| € 1,000 | EUR | EUR |
| Cash and cash equivalents | 1,375 | 1,339 |
| Other investments | 8,004 | 7,377 |
| Current liabilities | –17 | –17 |
| Non-current liabilities | –46 | –63 |
| Net liabilities | 9,317 | 8,636 |
| Liquid assets and other financial assets | 9,379 | 8,716 |
| Gross liabilities – fixed interest | –63 | –80 |
| Net liabilities | 9,317 | 8,636 |
Other investments are short-term money market investments that are traded on active markets and that are measured at fair value through profit and loss. In addition, the other investments include shares in Genetic Analysis AS, which are measured at fair value through comprehensive income.
| Financial | Financial | ||||||
|---|---|---|---|---|---|---|---|
| leasing | leasing | ||||||
| liabilities | liabilities | ||||||
| maturing within | maturing in | Loans maturing | Loans maturing | ||||
| Cash in | Other liquid | less than one | more than one | within less than | in more than | ||
| hand | assets | year | year | one year | one year | Total | |
| € 1,000 | EUR | EUR | EUR | EUR | EUR | EUR | EUR |
| Net liabilities 1 January 2017 | 597 | 7,134 | - | 2 | 0 | –5 | 7,728 |
| Cash flow | 757 | 377 | - | - | - | 1 | 1,136 |
| Purchases, financial leasing | - | - | - | - | –17 | –59 | –76 |
| Changes in exchange rates | –15 | - | - | - | - | - | –15 |
| Other changes not based on cash flow | - | –136 | - | - | - | - | –136 |
| Net liabilities 31 December 2017 | 1,339 | 7,375 | - | 2 | –17 | –63 | 8,636 |
| Cash flow | 43 | –19 | - | –1 | - | 17 | 40 |
| Purchases, financial leasing | - | - | - | - | - | - | 0 |
| Changes in exchange rates | –7 | - | - | - | - | - | –7 |
| Other changes not based on cash flow | - | 647 | - | - | - | - | 647 |
| Net liabilities 31 December 2018 | 1,375 | 8,003 | - | 1 | –17 | –46 | 9,317 |
| Recognised under other |
|||||
|---|---|---|---|---|---|
| Recognised | items of | ||||
| through profit | comprehensive | Businesses | |||
| € 1,000 | 1 Jan 2018 | and loss | income | purchased/sold | 31 Dec 2018 |
| Internal inventory margin | 6 | 0 | - | - | 6 |
| Other items | 61 | - | - | –13 | 48 |
| Total | 67 | 0 | - | –13 | 54 |
| Recognised through profit |
Recognised under other items of comprehensive |
Businesses | |||
|---|---|---|---|---|---|
| € 1,000 | 1 Jan 2018 | and loss | income | purchased/sold | 31 Dec 2018 |
| Capitalisation of intangible assets | 76 | - | - | –76 | - |
| Capitalisation of tangible assets | 6 | - | - | –3 | 3 |
| Financial securities measured via the fair value reserve | 229 | –11 | 158 | - | 376 |
| Total | 311 | –11 | 158 | –79 | 380 |
| Recognised | |||||
|---|---|---|---|---|---|
| Recognised | under other items | ||||
| through profit | of comprehensive | Businesses | |||
| € 1,000 | 1 Jan 2017 | and loss | income | purchased/sold | 31 Dec 2017 |
| Internal inventory margin | 6 | 0 | - | - | 6 |
| Other items | 101 | - | - | –40 | 61 |
| Total | 107 | 0 | - | –40 | 67 |
| Recognised | |||||
|---|---|---|---|---|---|
| Recognised under other items |
|||||
| through profit of comprehensive |
Businesses | ||||
| € 1,000 | 1 Jan 2017 | and loss | income | purchased/sold | 31 Dec 2017 |
| Capitalisation of intangible assets | 151 | - | - | –75 | 76 |
| Capitalisation of tangible assets | 5 | - | - | 1 | 6 |
| Financial securities measured via the fair value reserve | 256 | - | –27 | - | 229 |
| Total | 412 | - | –27 | –74 | 311 |
The Group has tax-deductible losses of EUR 19.3 million for the periods from 2012 to 2018 for which no deferred tax assets have been recognised. EUR 18.9 million of the loss is in Finland (2018: EUR 1.4 million, 2017: EUR 1.7 million, 2016: EUR 2.4 million, 2015: EUR 3.2 million, 2014: EUR 4.1 million, 2013: EUR 2.7 million, 2012: EUR 3.4 million) and EUR 0.4 million is in Italy. The losses expire in 10 years in Finland.
President & CEO Strategy and quality History Corporate governance Financial statements
| 20 | INVENTORIES | |
|---|---|---|
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Materials and supplies | 296 | 297 |
| Work in progress | 90 | 115 |
| Finished products/goods | 440 | 269 |
| Total inventories | 826 | 681 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Long-term interest-free receivables | 56 | 70 |
| Total | 56 | 70 |
| € 1,000 | 2018 | 2 017 |
|---|---|---|
| Trade receivables | 1 655 | 1,617 |
| Accrued income | 317 | 311 |
| Other receivables | 54 | 32 |
| Total | 2,025 | 1,960 |
The age analysis of the trade receivables is presented in note 28.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Business activities with no payment transactions: | ||
| The patents returned to the company when Biohit divested its holding in Biohit Healthcare (Hefei) Co. Ltd |
- | –7,053 |
| Other business activities that do not include payment transactions |
- | 296 |
| Cash amount received from the divestment of the holding in Biohit HealthCare (Hefei) Co. Ltd * |
- | –1,744 |
| Others | 2,012 | 1,816 |
| Total | 2,012 | –6,684 |
* See note 5
EQUIVALENTS
23
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Cash and cash equivalents | 1,375 | 1,339 |
Biohit Oyj's share capital is EUR 2,350,350.81 (EUR 2,350,350.81) and there are 14,952,041 (14,886,843) shares, of which 2,975,500 (2,975,500) belong to Series A and 11,976,541 (11,911,343) belong to Series B. Series B is listed on the stock exchange.
The shares have no nominal value. Shares in Series A and B differ from each other in that each Series A share entitles its holder to twenty (20) votes at general meetings, while each Series B share carries one (1) vote. The dividend paid for Series B shares is, however, two (2) per cent of the nominal value higher than that paid for Series A shares. When this regulation is applied, the nominal value of the shares is taken to be EUR 0.17, which was the nominal value of the company's shares when it decided to discontinue using nominal values for shares.
The shareholders' equity has been paid in full.
The translation differences reserve includes the translation differences arising when the financial statements of foreign subsidiaries and joint ventures are translated into euros.
The invested unrestricted equity fund includes other investments similar to shareholders' equity and the subscription prices of shares insofar as no specific decision is taken to recognise these under shareholders' equity.

| Adjusted shareholders' equity 1 January 2018 | Invested unrestrict | Translation | Fair value | Retained | Shareholders' equity | |
|---|---|---|---|---|---|---|
| € 1,000 | Share capital | ed equity fund | differences | reserve | earnings | Total |
| Shareholders' equity 1 January 2018 | 2,350 | 4,777 | –143 | 914 | 9,345 | 17,243 |
| Change in accounting policies due to IFRS 9, expected credit losses | - | - | - | - | –7 | –7 |
| Change in accounting policies due to IFRS 9, investments | - | - | - | –41 | 41 | 0 |
| Adjusted shareholders' equity 1 January 2018 | 2,350 | 4,777 | –143 | 873 | 9,379 | 17,236 |
Effect of the application of IFRS 9 on the opening balance sheet
The Group began to apply IFRS 9 (Financial Instruments) non-retrospectively on 1 January 2018. As regards shareholders' equity, the opening balance sheet was adjusted to move EUR 41,000 from comprehensive income to retained earnings because money market investments are measured at fair value through profit or loss due to the adoption of IFRS 9, while the same investments were measured at fair value through comprehensive income in the comparison period. Biohit only recognises changes in the fair value of Genetic Analysis AS in other items of comprehensive income.
In accordance with IFRS 9, impairment is recognised on the basis of expected credit losses. Biohit applies the simplified approach to recognising impairment provisions for trade receivables. The Group uses a calculation matrix for credit losses to calculate the credit loss provision for trade receivables, and the impact on retained earnings was negligible at EUR -7,000.
President & CEO Strategy and quality History Corporate governance Financial statements
Terms of share-based incentive schemes Biohit Oyj established an option programme within the framework of the share-based incentive scheme. The option programme is intended for senior managers and employees. In addition, the company granted options to two individuals as one-off compensation for amendments to the terms and conditions of certain old contracts. In accordance with the terms of the option programme, options are granted without cash payment, but a subscription price is set for the shares. The key terms and conditions of the incentive scheme, such as the terms relating to the creation of rights, are shown in the table below.
| I 2013 | ||
|---|---|---|
| Scheme | Types A, B, C, D, E | II 2013 |
| Nature of the scheme | Share options | Share options |
| Date of granting | 19 June 2013 | 19 June 2013 |
| Number of instruments granted | 500,000 | 420,000 |
| Subscription price | EUR 3.00 |
EUR 3.00 |
| Share price at the time of granting | EUR 5.36–7.35 |
EUR 5.36 |
| Period of validity (years) | 6 | 2 |
| Realisation | In shares | In shares |
The share options lapse if they are not exercised by the deadline specified in the programme. Under programme I 2013, an employee forfeits his/her incentives if he/ she leaves the Group before the right ultimately arises. The incentives provided for by programme II 2013 were earned in full before 31 December 2013.
| Number of options | 2018 | 2017 |
|---|---|---|
| Options in circulation at the beginning of the financial period |
178,750 | 367,060 |
| Options exercised | 65,198 | 188,310 |
| Options in circulation at the end of the financial period | 113,552 | 178,750 |
| Exercisable options at the end of the financial period | 113,552 | 178,750 |
| Weighted average strike price per share (EUR) | 2.28 | 2.28 |
The strike price is affected by dividends paid in accordance with the terms of the option programme. No dividend was paid for the financial period that ended on 31 December 2018, so the strike price did not change.
The following section describes the range of strike prices for options in circulation at the end of the financial period, as well as the weighted average period of validity remaining in accordance with the agreement.
| Range of strike prices (EUR) |
Weighted average period of validity (years) |
Number of stock options |
|
|---|---|---|---|
| 2018 | 0.0 | 0.4 | 113,552 |
| 2017 | 0.0 | 1.4 | 178,750 |
The Group uses the Black Scholes model to determine the fair value of its option schemes. The anticipated volatility is defined on the basis of the actual trend shown by the parent company's share price, taking into consideration the remaining period of validity of the options. The fair value of the shares in the option schemes is based on the quoted share price.
| Scheme | I 2013 | II 2013 |
|---|---|---|
| Anticipated volatility | 45% - 88% | 70% |
| Anticipated average period of validity of options on the issue date (years) |
6 | 2 |
| Risk-free rate (%) | 0.40% - 1.12% | 0.39% |
| Anticipated dividends (dividend yield) | subtracted from the subscription value |
subtracted from the subscription value |
| Fair value of the instrument defined on the date of issue (EUR) |
5.36 - 7.35 | 5.36 |
The amount recognised as expenses is included in note 7 ("Expenses arising from employment benefits").

| liabilities | ||
|---|---|---|
| € 1,000 | 2018 | 2017 |
| Non-current interest-bearing liabilities | ||
| Financial leasing liabilities | 42 | 59 |
| Total interest-bearing non-current liabilities |
42 | 59 |
| Current interest-bearing liabilities Principal payments for financial leasing |
||
| liabilities | 17 | 17 |
| Total interest-bearing current liabilities | 17 | 17 |
| Total interest-bearing liabilities | 59 | 76 |
The fair values of financial liabilities are presented in note 17.
There are no special covenants attached to the company's non-current financial lease liabilities.
The company has no subordinated loans.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Deferred tax liabilities | 380 | 311 |
| Other non-current liabilities | 4 | 4 |
| Total | 383 | 315 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Trade payables | 518 | 414 |
| Advances received | 73 | - |
| Tax liabilities | 13 | 8 |
| Accruals and deferred income | 949 | 839 |
| Total | 1,552 | 1,261 |
| Total interest-free liabilities | 1,935 | 1,576 |
The most substantial item included in accruals and deferred income is the deferral of employment benefits.
Biohit's management of financing risks focuses on analysing and minimising the following financing risks:
Exchange rate risks are associated with international business activities. When calculated using comparable currencies, Biohit's net sales are not materially different to the reported values. Overall, exchange rate changes did not significant affect the company's profitability in the last financial period. The company's sales are primarily denominated in euros and the company does not have any exchange rate hedging.
| € 1,000 | GBP | USD |
|---|---|---|
| Non-current liabilities | - | - |
| Open position | - | - |
| Current assets | ||
| Trade and other receivables | 244 | - |
| Current liabilities | ||
| Interest-free liabilities | –253 | - |
| Open position | –9 | - |
| Net position | –9 | - |
| 2017 | ||
| € 1,000 | GBP | USD |
| Non-current liabilities | - | - |
| Open position | - | - |
| Current assets | ||
| Trade and other receivables | 282 | - |
| Current liabilities | ||
| Interest-free liabilities | –249 | –41 |
| Open position | 34 | –41 |
| Net position | 34 | –41 |
The net position includes financial assets denominated in foreign currencies, as well as receivables and liabilities to Group companies and external parties translated into euros at the exchange rate on the final day of the reporting period.
President & CEO Strategy and quality History Corporate governance Financial statements

Interest rate changes have a minor effect on Biohit's earnings. For this reason, the Group did not use any separate hedging against this risk in the financial period.
Liquidity risk management aims to safeguard the Group's finances under all circumstances. The Group's current financial assets on the balance sheet date amounted to EUR 5.5 million (EUR 5.6 million). The company also holds shares in Genetic Analysis AS worth EUR 3.9 million (EUR 3.1 million). The aim of the investment activities related to the company's current liquid assets is to achieve profit at very low risk of capital loss.
The Group's equity ratio was 89.2% (91.3%).
| € 1,000 | ‹1 year | 1–5 years | ›5 years | Total |
|---|---|---|---|---|
| Accounts payable and other interest-free liabilities |
518 | - | - | 518 |
| Principal payments for financial leasing liabilities |
17 | 42 | - | 59 |
| Interest expenses for financial leasing liabilities |
3 | 8 | - | 11 |
| Total | 538 | 50 | - | 588 |
| € 1,000 | ‹1 year | 1–5 years | ›5 years | Total |
|---|---|---|---|---|
| Accounts payable and other interest-free liabilities |
414 | - | - | 414 |
| Principal payments for financial leasing liabilities |
17 | 59 | - | 76 |
| Interest expenses for financial leasing liabilities |
3 | 11 | - | 15 |
| Total | 434 | 71 | - | 505 |
The company is not using derivatives to hedge against commodity risks because the company is not exposed to commodity risks by virtue of the nature of its business.
The business units are responsible for the credit risks connected to their trade receivables, and they have evaluated the risk of credit losses for each customer. Biohit's customer base primarily consists of solvent companies. As such, Biohit's risk of credit losses cannot be considered significant. The company has not used credit insurance. The majority of customer relationships are long-term in nature and business relations are active, so the company will become aware of changes in customers' creditworthiness at an early stage.
The investment portfolio consists of direct corporate bond loans, structured products, corporate loan funds, money market funds and cash in bank accounts. Some of the products in the investment portfolio are listed, while others are not. Sufficient diversification of investments between asset categories, investment instruments and counterparties is essential. The company uses at least two partners in its investment activities. Approximately 12% of the investment portfolio is cash, low-risk money market fund investments and investment-grade investments. Approximately 24% of the portfolio is investments rated BB-B, while investments without credit ratings account for 64%.
On 31 December 2018, trade receivables totalled EUR 1.7 million (EUR 1.6 million). The majority of the trade receivable balance is due to be paid by Biohit HealthCare (Hefei) Co. Ltd. The maximum amount of credit risk is the book value of the trade receivables.

| € 1,000 | 2018 | Impairment loss | Net 2018 | 2017 | Impairment loss | Net 2017 |
|---|---|---|---|---|---|---|
| Not yet at maturity | 1,101 | –3 | 1,098 | 1,305 | - | 1 305 |
| Less than 30 days overdue | 283 | –2 | 281 | 129 | - | 129 |
| 30–60 days overdue | 182 | –8 | 174 | 125 | - | 125 |
| 61–90 days overdue | 51 | –7 | 44 | 23 | - | 23 |
| More than 90 days overdue | 78 | –20 | 57 | 65 | –29 | 36 |
| Total | 1,696 | –40 | 1,655 | 1,646 | –29 | 1,617 |
EUR 33 thousand (EUR 18 thousand) was recognised in credit losses for 2018.
The equity ratio – an indicator of the company's capital structure – is calculated by dividing the Group's equity by the balance sheet total less advances received. The result of this calculation is then multiplied by one hundred.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Total shareholders' equity | 15,892 | 17,243 |
| Balance sheet total | 17,887 | 18,895 |
| Advances received | –73 | - |
| Equity ratio | 89.2% | 91.3% |
Parties are considered to be related parties if one of the parties is able to exercise control or considerable influence over the other's decision-making related to finances and business. The Group's related parties include the members of the Board of Directors and the Group Management Team, as well as the President & CEO.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Parent company | ||
| Management Teams | 524 | 553 |
| President & CEO | 202 | 202 |
| Members of the scientific advisory board | 223 | 221 |
Osmo Suovaniemi has been employed by the company as a member of the scientific advisory board by the Board of Directors' decision. The compensation, including fringe benefits, is EUR 205 thousand (EUR 201 thousand). Stina Syrjänen, a member of the Board of Directors, was paid a consultancy fee of EUR 5 thousand for her services as a member of the scientific advisory board.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Subsidiaries | ||
| Managing Directors | 106 | 106 |
| € 1,000 | 2018 | 2017 | |
|---|---|---|---|
| Parent company | |||
| Osmo Suovaniemi | Chairman | 8 | 8 |
| Franco Aiolfi | Member | 8 | 8 |
| Matti Härkönen | Member | 8 | 5 |
| Eero Lehti | Member | 5 | 3 |
| Stina Syrjänen | Member | 5 | 6 |
| Liu Feng | Member | 5 | - |
| Seppo Luode | Member | - | 2 |
| Mikko Salaspuro | Member | - | 2 |
| Janina Andersson | Member | - | 2 |
| Total Board remuneration | 36 | 33 |
Liu Feng is the owner of Biohit HealthCare (Hefei) Co. Ltd, and he exercises control over the company.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Parent company | ||
| Management Teams | 11 | 263 |
| President & CEO | 86 | 291 |
| Key sales personnel | 11 | - |
On 31 December 2018, the members of the Board of Directors and President & CEO owned a total of 2,950,500 Series A shares and 4,516,533 Series B shares, either directly or through companies under their control. These correspond to 49.9% of all of the shares in the company and 88.9% of all of the votes.
Franco Aiolfi, a member of the Board of Directors, is the majority owner of Euroclone S.p.A. via a company called Arsfin Consult S.r.l. Euroclone S.p.A. owns 92,807 series B shares.
At the end of 2018, the Group's President & CEO held 0 options (40,000). In total, the members of the Group Management Team held 30,000 (80,000) option rights at the end of 2016, while other external parties or the company's key personnel held 83,522. Each option held by a member of senior management entitles the holder to one Series B share, which corresponds to 0.20% of all shares and 0.04% of all votes after subscription. The options in circulation represent 0.75% of all shares and 0.16% of all votes after subscription. The options held by the Group's President & CEO and members of the Group Management Team are subject to the same terms and conditions as the options held by others. Option bonuses granted to the company's managers are measured at fair value at the time of issue and recognised evenly as cost items throughout the period during which they were earned, which runs from 19 June 2013 to 31 May 2019.
President & CEO Strategy and quality History Corporate governance Financial statements
| Group | |
|---|---|
| Parent company: Biohit Oyj, Finland | ownership |
| Biohit Healthcare Ltd, United Kingdom | 100% |
| Biohit Healthcare S.r.l., Italy | 100% |
| Oy Finio Ab, Finland | 100% |
| Vantaan Hienomekano Oy, Finland | 100% |
Oy Finio Ab and Vantaan Hienomekano Oy were not in business in 2017 and 2018.
| Sales of goods and services to related party | ||
|---|---|---|
| companies | 2018 | 2017 |
| Sales of goods | ||
| Biohit HealthCare (Hefei) Co. Ltd | 2,751 | 1,076 |
| Sales of services | ||
| Biohit HealthCare (Hefei) Co. Ltd | 201 | 246 |
| Total | 2,953 | 1,322 |
In the review period, Biohit HealthCare (Hefei) Co. Ltd purchased 33.2% of all of the shares in Biohit Oyj, acquiring 29.5% of the voting rights based on shares. The transaction took place on 8 June 2018 and it resulted in Biohit HealthCare (Hefei) Co. Ltd obtaining substantial control over Biohit Oyj as per the IAS 28 standard. As a consequence, the transactions between 8 June 2018 and 31 December 2018 are classified as related party transactions and, as such, the sales of EUR 3.0 million for 2018 as referred to above are calculated according to this.
During the first half of 2017, Biohit Oyj sold its holding in Biohit HealthCare (Hefei) Co. Ltd, and the profit of this company was not consolidated into Biohit Oyj's profit from 1 June 2017 onwards, and the sales of
EUR 1.3 million as referred to above for 2017 accrued in the period to 31 May 2017.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Consultancy, administration and logistics fees (companies under the control of members of the Board of Directors) |
||
| Euroclone S.p.A., Franco Aiolfi | 66 | 82 |
| Biobrick, Franco Aiolfi | 25 | 25 |
| Oy Tech Know Ltd, Matti Härkönen | 55 | 53 |
| Gascol Tutkimus Oy, Mikko Salaspuro | 0 | 21 |
| Total | 146 | 180 |
| Ownership stakes in joint ventures | ||
| Biohit HealthCare (Hefei) Co. Ltd * | - | 0 % |
* See note 5
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Collateral pledged on the company's own behalf |
||
| Guarantees | 4 | 3 |
| Other liabilities | ||
| Leasing commitments: | ||
| Due for payment in one year | 26 | 51 |
| Due for payment in more than one year but less than five years |
14 | 36 |
| Due for payment in more than five years |
- | - |
| Total | 40 | 87 |
| Other lease commitments: | ||
| Due for payment in one year | 178 | 196 |
| Due for payment in more than one year but less than five years |
86 | 262 |
| Due for payment in more than five years |
- | - |
| Total | 264 | 458 |
| Total other liabilities | 304 | 545 |
| Total collateral and contingent liabilities | 307 | 548 |
The company's management is not aware of any material events since the balance sheet date.
Key indicators
| IFRS | IFRS | IFRS | IFRS | IFRS | |
|---|---|---|---|---|---|
| 2014 | 2015 | 2016 | 2017 | 2018 | |
| Net sales | 4,363 | 6,051 | 8,195 | 8,979 | 9,931 |
| Change in net sales (%) | 26.4% | 38.7% | 35.4% | 9.6% | 10.6% |
| Operating profit/loss | –4,504 | –2,900 | –3,356 | 6,356 | –1,965 |
| Proportion of net sales (%) | –103.2% | –47.9% | –41.0% | 70.8% | –19.8% |
| Profit/loss before extraordinary items and taxes | –4,312 | –2,903 | –3,275 | 6,405 | –2,024 |
| Proportion of net sales (%) | –98.8% | –48.0% | –40.0% | 71.3% | –20.4% |
| Profit/loss before taxes | –4,312 | –2,903 | –3,275 | 6,405 | –2,024 |
| Proportion of net sales (%) | –98.8% | –48.0% | –40.0% | 71.3% | –20.4% |
| Return on equity (%) | –24.5% | –25.3% | –31.1% | 45.8% | –12.2% |
| Return on investments (%) | –23.8% | –22.8% | –29.4% | 46.3% | –10.9% |
| Equity ratio | 87.5% | 87.9% | 83.0% | 91.3% | 89.2% |
| Investments in fixed assets | 447 | 832 | 115 | 7,232 | 13 |
| Proportion of net sales (%) | 10.2% | 13.8% | 1.4% | 80.6% | 0.1% |
| Research and development expenditure | 1,942 | 1,914 | 1,852 | 1,209 | 1,290 |
| Proportion of net sales (%) | 44.5% | 31.6% | 22.6% | 13.5% | 13.0% |
| Balance sheet total | 14,508 | 11,728 | 12,989 | 18,895 | 17,887 |
| Average number of personnel | 50 | 52 | 53 | 51 | 50 |
| IFRS | IFRS | IFRS | IFRS | IFRS | |
|---|---|---|---|---|---|
| 2014 | 2015 | 2016 | 2017 | 2018 | |
| Earnings per share, undiluted (EUR) | –0.32 | –0.20 | –0.22 | 0.42 | –0.14 |
| Shareholders' equity attributable to the owners of the | |||||
| parent company (EUR per share) | 0.90 | 0.72 | 0.73 | 1.16 | 1.06 |
| Price-to-earnings ratio (P/E) | 0.0 | 0.0 | 0.0 | 9.0 | –21.1 |
| Dividend per share | |||||
| Repayment of capital per share | |||||
| Dividend payout ratio (%) | |||||
| Effective dividend yield (%) | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Series B share price trend (EUR) | |||||
| - Average | 6.35 | 5.45 | 5.57 | 5.44 | 4.37 |
| - Low | 4.57 | 4.22 | 4.71 | 3.74 | 2.94 |
| - High | 8.17 | 7.14 | 6.42 | 6.85 | 6.20 |
| - Price 31 December | 4.68 | 5.61 | 6.05 | 3.77 | 2.96 |
| Market capitalisation EUR 1,000 | |||||
| (presuming the same market value for Series A shares |
|||||
| as for Series B shares) | 66,155 | 80,495 | 88,926 | 56,123 | 44,258 |
| Turnover of Series B shares (thousands) | 4,029 | 4,014 | 2,159 | 3,302 | 8,616 |
| - proportion of the total (%) | 37.2% | 37.0% | 19.9% | 27.7% | 71.9% |
| Average ex-rights adjusted number of | |||||
| shares | 13,941,286 | 14,276,519 | 14,685,071 | 14,764,411 | 14,901,904 |
| - taking into consideration the diluting effect of | |||||
| options and convertible bonds | 14,521,286 | 14,703,579 | 15,052,131 | 14,943,161 | 15,015,256 |
| Ex-rights adjusted number of | |||||
| shares at the end of the financial period | 14,135,593 | 14,348,533 | 14,698,533 | 14,886,843 | 14,952,041 |
| - taking into consideration the diluting effect of options and convertible bonds |
14,715,593 | 14,775,593 | 15,065,593 | 15,065,593 | 15,065,593 |
The company has options that have a diluting effect. As the company is loss-making, the diluting effect has not been presented.
Shares and shareholders
| Number of owners |
Number of shares |
|||
|---|---|---|---|---|
| Series A shares | shares | % | shares | % |
| 1. Companies | 1 | 10.0 | 24,990 | 0.8 |
| 2. Households | 9 | 90.0 | 2,950,510 | 99.2 |
| Shares on the waiting list |
0 | 0.0 | ||
| Total number of Series A shares | 10 | 100.0 | 2,975,500 | 100.0 |
| Number of owners |
Number of shares |
|||
|---|---|---|---|---|
| Series B shares | shares | % | shares | % |
| 1. Households | 6,589 | 96.4 | 5,965,941 | 49.8 |
| 2. Financial and insurance institutions |
14 | 0.2 | 511,576 | 4.3 |
| 3. Companies and housing companies |
200 | 2.9 | 519,933 | 4.3 |
| 4. Non-profit organisations | 8 | 0.1 | 4,181 | 0.0 |
| 5. Public corporations | 0 | 0.0 | 0 | 0.0 |
| 6. Nominees and foreign owners | 26 | 0.4 | 4,119,318 | 34.4 |
| In joint and clearing accounts | 0 | 0.0 | 855,592 | 7.1 |
| Total number of Series B shares | 6,837 | 100.0 | 11,976,541 | 100.0 |
| Total number of Series A and Series B shares |
6,847 | 14,952,041 |
| Number of owners |
Number of shares |
|||
|---|---|---|---|---|
| Series A shares | shares | % | shares | % |
| 1–1,000 | 0 | 0.0 | 0 | 0.0 |
| 1,001–10,000 | 3 | 30.0 | 25,000 | 0.8 |
| 10,001–100,000 | 3 | 30.0 | 156,990 | 5.3 |
| More than 100,001 | 4 | 40.0 | 2,793,510 | 93.9 |
| Total number of Series A shares | 10 | 100.0 | 2,975,500 | 100.0 |
| Number of owners |
Number of shares |
|||
|---|---|---|---|---|
| Series B shares | shares | % | shares | % |
| 1–1,000 | 5,832 | 85.3 | 1,534,699 | 12.8 |
| 1,001–10,000 | 874 | 12.8 | 2,583,728 | 21.6 |
| 10,001–100,000 | 129 | 1.9 | 2,895,458 | 24.2 |
| More than 100,001 | 2 | 0.0 | 4,107,064 | 34.3 |
| Shares in joint and clearing | ||||
| accounts | 0 | 0.0 | 855,592 | 7.1 |
| Total number of Series B shares | 6,837 | 100.0 | 11,976,541 | 100.0 |
| Total number of Series A and Series B shares |
6,847 | 14,952,041 |
| Total | ||||
|---|---|---|---|---|
| 10 largest owners in terms of the number of shares |
Series A shares |
Series B shares |
number of shares |
% |
| Biohit Healthcare (Hefei) Co., Ltd. |
850,000 | 4,095,415 | 4,945,415 | 33.1 |
| Suovaniemi Osmo Antero | 2,018,310 | 0 | 2,018,310 | 13.5 |
| Härkönen Matti | 57,200 | 267,965 | 325,165 | 2.2 |
| Oy Etra Invest Ab | 0 | 200,000 | 200,000 | 1.3 |
| Evli Bank Plc | 0 | 130,000 | 130,000 | 0.9 |
| Suovaniemi Vesa Jukka Markku | 0 | 85,353 | 85,353 | 0.6 |
| Syrjälä Pekka | 0 | 77,495 | 77,495 | 0.5 |
| Kähkönen Jouko Juhani | 0 | 76,000 | 76,000 | 0.5 |
| Harmes Arjo | 0 | 74,500 | 74,500 | 0.5 |
| Jaakkola Sami Juhani | 0 | 70,608 | 70,608 | 0.5 |
| 10 largest owners in terms of the number of votes |
Series A shares |
Series B shares |
Total votes | % |
|---|---|---|---|---|
| Suovaniemi Osmo Antero | 2,018,310 | 0 | 40,366,200 | 56.5 |
| Biohit Healthcare (Hefei) Co., Ltd. |
850,000 | 4,095,415 | 21,095,415 | 29.5 |
| Härkönen Matti | 57,200 | 267,965 | 1,411,965 | 2.0 |
| Oy Tech Know Ltd | 24,990 | 43,600 | 543,400 | 0.8 |
| Oy Etra Invest Ab | 0 | 200,000 | 200,000 | 0.3 |
| Evli Bank Plc | 0 | 130,000 | 130,000 | 0.2 |
| Suovaniemi Vesa Jukka Markku | 0 | 85,353 | 85,353 | 0.1 |
| Syrjälä Pekka | 0 | 77,495 | 77,495 | 0.1 |
| Kähkönen Jouko Juhani | 0 | 76,000 | 76,000 | 0.1 |
| Harmes Arjo | 0 | 74,500 | 74,500 | 0.1 |
On 31 December 2018, the members of the Board of Directors and President & CEO owned a total of 2,950,500 Series A shares and 4,516,533 Series B shares, either directly or through companies under their control. These correspond to 49.9 per cent of all of the shares in the company and 88.9 per cent of all of the votes. Franco Aiolfi, a member of the Board of Directors, is the majority owner of Euroclone S.p.A. via a company called Arsfin Consult S.r.l. Euroclone S.p.A. owns 92,807 series B shares.
Formulae for calculating key indicators
President & CEO Strategy and quality History Corporate governance Financial statements
| profit/loss for the financial period | |
|---|---|
| Return on equity (%) | shareholders' equity (average for the year) |
| profit before extraordinary items + interest and other financial expenses |
|
| Return on investments (%) | balance sheet total - interest-free liabilities (average for the year) |
| Equity ratio (%) | shareholders' equity on the balance sheet |
| balance sheet total - advances received | |
| profit/loss for the financial period | |
| Earnings per share (EUR) | average number of ex-rights shares during the period |
| Shareholders' equity per share | shareholders' equity on the balance sheet |
| (EUR) | number of shares on the balance sheet date |
| dividend distributed for the financial period | |
| Dividend per share (EUR) | number of shares on the balance sheet date |
| Dividend per share | |
| Dividend payout ratio (%) | earnings per share |
| Dividend per share | |
| Effective dividend yield (%) | last transaction rate in the financial period |
| Price-to-earnings ratio (P/E) | last transaction rate in the financial period |
| earnings per share |
The new instructions issued by the European Securities and Markets Authority (ESMA) on Alternative Performance Measures (APMs) took effect for the 2016 financial period. In conjunction with the transition to an income statement model based on expense types, Biohit will present APMs to describe the financial development of its business and improve comparability between different periods. APMs should not be considered substitutes for the key indicators specified in the IFRS norms for financial statements. The operational key indicators have been adjusted for certain measurement items that do not constitute part of ordinary business activities or that do not affect cash flow during the period but that affect comparability. The items that affect comparability and the APMs used by Biohit Oyj are defined as follows:
Items that affect comparability:
Certain business transactions that do not constitute part of ordinary business activities or measurement items that do not affect cash flow but that have a significant effect on the income statement for the period have been adjusted for items that affect comparability. This items arise through non-recurring transactions such as:
In addition, Biohit Oyj presents the following APMs:
EBITDA (EUR) = operating profit + depreciation and impairment
Operative EBITDA (EUR) = operating profit + depreciation, impairment - items affecting comparability
Free cash flow (FCF) (EUR) = Cash flow from operating activities - Investments and tangible and intangible assets + Revenue from disposal of tangible and intangible assets
PARENT COMPANY'S FINANCIAL STATEMENTS *

| €1,000 | Note | 1 Jan - 31 Dec 2018 | 1 Jan - 31 Dec 2017 |
|---|---|---|---|
| Net sales | 2 | 7,427 | 6,865 |
| Change in inventories of finished and unfinished products | 151 | –137 | |
| Other operating income | 3 | 205 | 262 |
| Materials and services | 4 | –2,728 | –2,586 |
| Personnel expenses | 5 | –2,780 | –2,817 |
| Other operating expenses | 6 | –2,911 | –2,313 |
| EBITDA | –635 | –727 | |
| Depreciation and amortization | 7 | –1,715 | –1,188 |
| Operating profit/loss | –2,350 | –1,915 | |
| Financial income and expenses | 9 | 849 | 8,858 |
| Profit/loss before appropriations and taxes | –1,502 | 6,943 | |
| Withholding tax | 10 | –14 | –201 |
| Profit/loss for the financial period | –1,516 | 6,742 |
| € 1,000 | Note | 31 Dec | 2018 31 Dec 2017 |
|---|---|---|---|
| Assets | |||
| Non-current assets | |||
| Intangible assets | 11 | 4,736 | 6,306 |
| Tangible assets | 12 | 508 | 643 |
| Investments | |||
| Shares in Group companies | 13 | 232 | 232 |
| Other investments | 13 | 1 | 1 |
| Total fixed assets | 5,477 | 7,182 | |
| Current assets | |||
| Inventories | 14 | 699 | 549 |
| Long-term receivables | 15 | 255 | - |
| Short-term receivables | 15 | 1,822 | 1,960 |
| Financial securities | 16 | 7,992 | 7,363 |
| Cash at bank and in hand | 17 | 912 | 413 |
| Total current assets | 11,680 | 10,286 | |
| TOTAL ASSETS | 17,157 | 17,467 |
| 31 Dec | |||
|---|---|---|---|
| € 1,000 | Note | 2018 31 Dec 2017 | |
| Liabilities and shareholders' equity | |||
| Shareholders' equity | |||
| Share capital | 18 | 2,350 | 2,350 |
| Fair value reserve | 18 | 1,505 | 914 |
| Invested unrestricted equity fund | 18 | 3,829 | 3,681 |
| Retained earnings | 18 | 9,011 | 2,228 |
| Profit/loss for the financial period | 18 | –1,516 | 6,742 |
| Total shareholders' equity | 15,179 | 15,915 | |
| Liabilities | |||
| Long-term liabilities | 19, 20 | 719 | 589 |
| Short-term liabilities | 21 | 1,259 | 964 |
| Total liabilities | 1,978 | 1,552 | |
| TOTAL LIABILITIES AND SHAREHOLDERS' | |||
| EQUITY | 17,157 | 17,467 |

| € 1,000 Note |
2018 | 2017 |
|---|---|---|
| Cash flow from operating activities: | ||
| Profit/loss before appropriations and taxes | –1,502 | 6,943 |
| Adjustments: | ||
| Planned depreciation | 1,715 | 1,188 |
| Unrealised exchange rate gains and losses | –1 | –1 |
| Other income and expenses unconnected to payment | 1 | –158 |
| Financial income and expenses 9 |
–849 | –8,858 |
| Change in working capital: | ||
| Increase (-)/decrease (+) in short-term interest-free trade receivables | –106 | –78 |
| Increase (-)/decrease (+) in inventories | –150 | 183 |
| Increase (+)/decrease (-) in short-term interest-free liabilities | 292 | –594 |
| Realised exchange rate gains and losses | - | –12 |
| Interest paid and payments on other operating financial expenses | –71 | –34 |
| Dividends received | 895 | - |
| Income and interest received from business activities | 136 | 140 |
| Cash flow from operating activities | 361 | –1,282 |
| Cash flow from investments: | ||
| Investments in tangible and intangible assets | –10 | –159 |
| Revenue from disposal of tangible and intangible assets | –2 | 1,688 |
| Investments in other instruments | –2,112 | –877 |
| Revenue from disposal of other investments | 2,131 | 500 |
| Cash flow from investments | 7 | 1,152 |
| Cash flow from financing activities: | ||
| Paid share issue | 148 | 429 |
| Repayment of short-term loans | - | 88 |
| Repayment of long-term loans | –17 | –11 |
| Cash flow from financing activities | 131 | 505 |
| Increase (+)/decrease (-) in cash and cash equivalents | 500 | 375 |
| Cash and cash equivalents at the beginning of the period | 413 | 38 |
| Cash and cash equivalents at the end of the period 17 |
912 | 413 |
When preparing the financial statements in accordance with good accounting practices, the company's senior managers are called upon to make estimates and assumptions that affect the content of the financial statements. The outcomes may differ from these estimates.
The parent company's financial statements have been prepared in accordance with the Finnish Accounting Act.
The financial statements present figures in thousands of euros based on the original values of business transactions, with the exception of financial securities, a component of current assets, which are measured at fair value.
Property, plant and equipment are recognised on the balance sheet at acquisition cost, less received contributions, planned depreciation and impairments. Planned depreciation is calculated using a straight-line model based on the useful life of the asset.
| The planned depreciation periods are as follows: | |
|---|---|
| Intangible rights: | 3–10 years |
| Other long-term expenses: | 5–10 years |
| Plant and equipment: | 3–10 years |
Inventories are presented in accordance with the FIFO principle at acquisition cost or replacement cost or likely sale price, whichever is lower. The acquisition cost of inventories includes variable costs as well as the allotted proportion of the fixed expenses of purchasing and manufacturing.
Financial securities, which belong to current assets, are measured at fair value in accordance with section 5.2a of the Finnish Accounting Act. The fair value of investments is determined based on price quotations on active markets, i.e., the buy quotation on the closing date of the financial period. Unrealised profits and losses due to changes in the fair value of money market investments are recognised in the income statement under financial income and expenses in accordance with the Group's updated accounting policies, which took effect at the beginning of 2018. In the comparison period (2017), they were recognised on the balance sheet in the fair value reserve and on the income statement under financial income and expenses in the period when they were realised. Investments recognised via the fair value reserve consist solely of the equity investment in the unlisted shares in Genetic Analysis AS.
Research expenses are recognised as annual expenses in the year in which they were incurred.
When calculating net sales, indirect sales taxes and discounts are deducted from sales revenues. Sales of work performances are recognised when they are handed over.
Maintenance and repair expenses are recognised as expenses for the financial period. The costs of renovating leased offices are capitalised under other long-term expenses and are subject to straight-line depreciation for the remained for the lease period.
The company's statutory pension cover and any applicable additional benefits is insured by a pension insurance company. Pension expenses are recognised on the basis of work performed by employees during working hours.
No deferred taxes have been recognised on the balance sheet. In accordance with general guidelines issued by the Accounting Board on 12 September 2006, the amounts of deferred taxes that must be entered into the balance sheet are presented in the notes, along with the amounts of tax liabilities and assets that should not be entered into the balance sheet because they are unlikely to be realised.
Receivables and liabilities in foreign currencies have been translated into euros at the exchange rate quoted by the European Central Bank on the balance sheet date. Translation differences have been recognised through profit and loss.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Diagnostics | 7,427 | 6,865 |
| Total | 7,427 | 6,865 |
| 1000 € | 2018 | 2017 |
|---|---|---|
| Finland | 438 | 390 |
| Europe, other | 1,153 | 922 |
| North and South America | 158 | 223 |
| Asia | 4,682 | 4,562 |
| Other countries | 996 | 769 |
| Total | 7,427 | 6,865 |
In year 2017 India was part of the market area other countries but in 2018 it is relocated under market area Asia.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| From Group companies | 188 | 159 |
| Others | 17 | 103 |
| Total | 205 | 262 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Purchases during the financial period | 2,726 | 2,540 |
| Change in inventories | 2 | 46 |
| Total materials and supplies | 2,728 | 2,586 |
| Total materials and services | 2,728 | 2,586 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Salaries | 2,404 | 2,413 |
| Pension expenses | 345 | 358 |
| Other personnel expenses | 32 | 47 |
| Total personnel expenses | 2,780 | 2,817 |
| In the financial period, the parent company employed an average of |
2018 | 2017 |
|---|---|---|
| Office personnel | 42 | 41 |
| Average number of personnel | 42 | 41 |
| Number of personnel at the end of the financial | ||
| period | 41 | 42 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Travel expenses and other personnel expenses | 320 | 254 |
| Rents and maintenance expenses | 299 | 305 |
| Sales and marketing expenses | 852 | 353 |
| Other external services | 942 | 868 |
| Change in value of trade receivables | 13 | 41 |
| Other operating expenses | 486 | 491 |
| Total | 2,911 | 2,313 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Intangible assets | 1,570 | 884 |
| Plant and equipment | 145 | 151 |
| Impairment | - | 153 |
| Total | 1,715 | 1,188 |


In the 2018 financial statements, the balance sheet value of patents related to the 2017 sale of Biohit HealthCare (Hefei) Co. Ltd was EUR 4.6 million. The patents will be subject to straight-line depreciation until the end of 2021. Impairment testing will be performed on the value of patents whenever there is an indication of impairment.
An impairment test was conducted in conjunction with the 2018 financial statements. No impairment was recognised based on the impairment test. There is uncertainty concerning the future cash flows used for impairment testing as illustrated by the sensitivity analysis below for three factors:
| € 1,000 | 2018 |
|---|---|
| WACC (%) increased by 1% and impact on the value of patents | –60 |
| WACC (%) increased by 5% and impact on the value of patents | –300 |
| The required return on capital depends on the interest environment and the risk level of equities. |
|
| One-year delay to the initiation of production in China and impact on the value of patents Two-year delay to the initiation of production in China and impact on the value of patents |
–500 –1,700 |
| (Hefei) Royalty-based cash flow is dependent on the readiness of Biohit Healtcare Co. Ltd's production facilities in terms of sufficient production quality and ready production capacity. According to the latest estimate, the expanded Q1/2020 production capacity will become available by the end of when the distributor has received all of the permits from the authorities to allow production to begin. |
|
| Decrease in demand for GastroPanel® by 20% and impact on the value of patents Decrease in demand for GastroPanel® by 40% and impact on the value of patents |
–100 –1,200 |
Royalty-based cash flow is dependent on the growth of the Chinese market, successful sales work by the distributor and building up the brand.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Companies belonging to the Pricewater - |
||
| houseCoopers chain | ||
| Auditors' fees | 67 | 63 |
| Auditors' statements | 10 | 6 |
| Tax service | - | 8 |
| Other services | 4 | 22 |
| Total fees paid to the auditor | 81 | 99 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Dividend income | ||
| From Group companies | 895 | - |
| Total dividend income | 895 | - |
| Other interest and financial income | ||
| From Group companies | 6 | 6 |
| From others* | 152 | 8,930 |
| Other interest and financial income | 158 | 8,936 |
| Total financial income | 1,053 | 8,936 |
| Interest expenses and other financial expenses | ||
| To Group companies | –2 | –5 |
| To others | –202 | –73 |
| Total financial expenses | –204 | –78 |
| Total financial income and expenses | 849 | 8,858 |
| Financial income and expenses include foreign | ||
| exchange gains/losses (net) | 0 | –52 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Tax based on taxable income for the financial | ||
| period | - | - |
| Withholding tax | 14 | 201 |
| Total | 14 | 201 |
| € 1,000 | Intangible rights |
Total |
|---|---|---|
| Acquisition cost at the beginning of the financial period |
7,942 | 7,942 |
| Acquisition cost at the end of the financial period |
7,942 | 7,942 |
| Accumulated depreciation and impairment in the financial period Depreciation and impairment in the |
–1,636 | –1,636 |
| financial period | –1,570 | –1,570 |
| Accumulated depreciation at the end of the financial period |
–3,205 | –3,205 |
| Book value at the beginning of the financial period Book value at the end of the |
6,306 | 6,306 |
| financial period | 4,736 | 4,736 |
| AUDITORS' FEES | 11 INTANGIBLE ASSETS |
||||
|---|---|---|---|---|---|
| € 1,000 | 2018 | 2017 | |||
| Companies belonging to the Pricewater - |
2018 | ||||
| houseCoopers chain | Intangible | ||||
| Auditors' fees | 67 | 63 | € 1,000 | rights | Total |
| Auditors' statements | 10 | 6 | Acquisition cost at the beginning of | ||
| Tax service | - | 8 | the financial period | 7,942 | 7,942 |
| Other services | 4 | 22 | Acquisition cost at the end of the | ||
| Total fees paid to the auditor | 81 | 99 | financial period | 7,942 | 7,942 |
| Accumulated depreciation and | |||||
| FINANCIAL INCOME AND EXPENSES | impairment in the financial period | –1,636 | –1,636 | ||
| Depreciation and impairment in the | |||||
| € 1,000 | 2018 | 2017 | financial period | –1,570 | –1,570 |
| Dividend income | Accumulated depreciation at the end of the financial period |
–3,205 | –3,205 | ||
| From Group companies | 895 | - | |||
| Total dividend income | 895 | - | Book value at the beginning of the | ||
| Other interest and financial income | financial period | 6,306 | 6,306 | ||
| From Group companies | 6 | 6 | Book value at the end of the | ||
| From others* Other interest and financial income |
152 158 |
8,930 8,936 |
financial period | 4,736 | 4,736 |
| Total financial income | 1,053 | 8,936 | |||
| Interest expenses and other financial expenses | |||||
| To Group companies | –2 | –5 | 2017 | ||
| To others | –202 | –73 | € 1,000 | Intangible rights |
Total |
| Total financial expenses | –204 | –78 | Acquisition cost at the beginning of | ||
| Total financial income and expenses | 849 | 8,858 | the financial period | 889 | 889 |
| Financial income and expenses include foreign | Increases | 7,053 | 7,053 | ||
| exchange gains/losses (net) | 0 | –52 | Acquisition cost at the end of the | ||
| financial period | 7,942 | 7,942 | |||
| *) In 2017, the other interest and financial income consisted primarily of profit recognised from the | Accumulated depreciation and | ||||
| disposal of shares in the joint venture. | impairment in the financial period | –603 | –603 | ||
| The items above operating profit include foreign exchange losses/gains (net) or | Depreciation and impairment in the | ||||
| EUR -5 thousand (EUR -9 thousand) |
financial period | –1,033 | –1,033 | ||
| Accumulated depreciation at the end | |||||
| of the financial period | –1,636 | –1,636 | |||
| INCOME TAXES | Book value at the beginning of the | ||||
| € 1,000 | 2018 | 2017 | financial period | 286 | 286 |
| Tax based on taxable income for the financial | Book value at the end of the | ||||
| period | - | - | financial period | 6,306 | 6,306 |
| Withholding tax | 14 | 201 | |||
| Total | 14 | 201 | |||
| BIOHIT OYJ | ANNUAL REPORT 2018 | 77 |
| € 1,000 | Plant and equipment |
Total |
|---|---|---|
| Acquisition cost at the beginning of the financial | ||
| period | 1,570 | 1,570 |
| Increases | 32 | 32 |
| Decreases | –83 | –83 |
| Acquisition cost at the end of the | ||
| financial period | 1,519 | 1,519 |
| Accumulated depreciation and | ||
| impairment in the financial period | –927 | –927 |
| Accumulated depreciation of | ||
| decreases | 61 | 61 |
| Depreciation in the financial period | –145 | –145 |
| Accumulated depreciation at the end | ||
| of the financial period | –1,011 | –1,011 |
| Book value at the beginning of the | ||
| financial period | 643 | 643 |
| Book value at the end of the | ||
| financial period | 508 | 508 |
| Plant and | ||
|---|---|---|
| € 1,000 | equipment | Total |
| Acquisition cost at the beginning of the financial | ||
| period | 1,412 | 1,412 |
| Increases | 170 | 170 |
| Decreases | –13 | –13 |
| Acquisition cost at the end of the financial period | 1,570 | 1,570 |
| Accumulated depreciation and impairment in the | ||
| financial period | –779 | –779 |
| Accumulated depreciation of decreases | 3 | 3 |
| Depreciation in the financial period | –151 | –151 |
| Accumulated depreciation at the end of the | ||
| financial period | –927 | –927 |
| Book value at the beginning of the financial period | 634 | 634 |
| Book value at the end of the financial period | 643 | 643 |
| Group | |||
|---|---|---|---|
| € 1,000 | companies | Others | Total |
| Book value at the beginning of the | |||
| financial period | 232 | 1 | 233 |
| Book value at the end of the | |||
| financial period | 232 | 1 | 133 |
| Group com - |
|||
|---|---|---|---|
| € 1,000 | panies | Others | Total |
| Book value at the beginning of the | |||
| financial period | 232 | 1 | 233 |
| Book value at the end of the | |||
| financial period | 232 | 1 | 233 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Materials and | ||
| supplies | 296 | 297 |
| Work in progress | 90 | 111 |
| Finished products/goods | 314 | 138 |
| In transit | - | 3 |
| Total inventories | 699 | 549 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Long-term receivables | ||
| Receivables from Group companies | ||
| Loan receivables | 255 | - |
| Total non-current receivables | 255 | - |
| Short-term receivables | ||
| Receivables from Group companies | ||
| Trade receivables | 172 | 238 |
| Loan receivables | - | 255 |
| Other receivables | 57 | 53 |
| Accrued income | 6 | 6 |
President & CEO Strategy and quality History Corporate governance Financial statements
| ← | - | |
|---|---|---|
| P |
| Other receivables | ||
|---|---|---|
| Trade receivables | 1,244 | 1,105 |
| Other receivables | 208 | 192 |
| Accrued income | 134 | 112 |
| Total current receivables | 1,822 | 1,960 |
| € 1,000 | 2018 | Level 2 | Level 3 |
|---|---|---|---|
| Traded securities and investment to | |||
| unlisted company* | 7,992 | 4,130 | 3,862 |
| * Genetic Analysis AS |
| € 1,000 | 2017 | Level 2 | Level 3 |
|---|---|---|---|
| Traded securities | 7,363 | 4,291 | 3,072 |
Financial securities consist of fixed-income investments, corporate loans and money market investments.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Cash in hand and at bank | 912 | 413 |
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Share capital 1 January | 2,350 | 2,350 |
| Share capital 31 December | 2,350 | 2,350 |
| Fair value reserve 1 January | 914 | 1,024 |
| Increases | 632 | - |
| Change in accounting policies, investments Decreases Fair value reserve 31 December |
-41 - 1,505 |
-110 914 |
|---|---|---|
| Invested unrestricted equity fund 1 January Subscription of options |
3,681 148 |
3,252 429 |
| Invested unrestricted equity fund 31 December | 3,829 | 3,681 |
| Retained earnings 1 January Change in accounting policies, investments Retained earnings 31 December |
8,970 41 9,011 |
2,228 - 2,228 |
| Reported profit/loss for the financial period |
-1,516 | 6,742 |
| Total shareholders' equity | 15,179 | 15,915 |
Biohit's shares are divided into Series A and Series B shares. The series from each other in that each Series A share entitles its holder to twenty (20) votes at general meetings, while each Series B share carries one (1) vote. The dividend paid for Series B shares is, however, two (2) per cent of the nominal value higher than that paid for Series A shares. When this regulation is applied, the nominal value of the shares is taken to be EUR 0.17, which was the nominal value of the company's shares when it decided to discontinue using nominal values for shares.
| Calculation of distributable equity 31 December |
2018 | 2017 |
|---|---|---|
| Retained earnings | 9,011 | 2,228 |
| Profit/loss for the | ||
| financial period | –1,516 | 6,742 |
| Invested unrestricted equity fund | 3,829 | 3,681 |
| Total | 11,324 | 12,650 |
President & CEO Strategy and quality History Corporate governance Financial statements
| 2018 | 2017 | |||
|---|---|---|---|---|
| Parent company's share capital |
||||
| structure | shares | % of shares | % of votes | shares |
| Series A shares (20 votes per share) |
2,975,500 | 19.9 | 83.3 | 2,975,500 |
| Series B shares (1 | ||||
| vote per share) | 11,976,541 | 80.1 | 16.7 | 11,911,343 |
| Total | 14,952,041 | 100.0 | 100.0 | 14,886,843 |
The company's share capital is EUR 2,350,350.81. The company does not hold any of its own shares. Based on a resolution of the AGM held on 25 April 2018, the Board of the company is authorised to decide on the issue of shares and to issue the special rights referred to in Chapter 10 of the Limited Liability Companies Act so that the maximum number of new Series B shares to be issued pursuant to the special rights is 3,000,000, which corresponds to approximately 25.0% of all of the company's Series B shares. In 2018, the company did not issue any new shares under the authorisation granted on 25 April 2018.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Loans from Group companies | 301 | 301 |
| Loans from financial institutions | 42 | 59 |
| From others | 376 | 229 |
| Total | 719 | 589 |
Long-term liabilities from others are deferred tax liabilities.
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Assets classed as available for sale | 376 | 229 |
| Total | 376 | 229 |
The company only recognises fair value changes in Genetic Analysis AS in the fair value reserve, and the deferred tax related to this is presented on the balance sheet.
The deferred tax assets due to confirmed losses have not been recognised on the balance sheet. Confirmed losses, including the loss for the 2018 financial period, total EUR 18.9 million (2018: EUR 1.4 million, 2017: EUR 1.7 million, 2016: EUR 2.4 million, 2015: EUR 3.2 million, 2014: EUR 4.1 million, 2013: EUR 2.7 million, 2012: EUR 3.4 million).
| € 1,000 | 2018 | 2017 |
|---|---|---|
| Loans from financial institutions, current | ||
| proportion | 17 | 17 |
| Advances received | 73 | - |
| Trade payables | 433 | 317 |
| Accruals and deferred | ||
| income | 536 | 509 |
| Other liabilities | 164 | 85 |
| Liabilities to Group companies | ||
| Accruals and | ||
| deferred income | 37 | 35 |
| Total short-term liabilities | 1,259 | 964 |
The significant items of accruals and deferred income are salary-related deferred items valued at EUR 355 thousand (EUR 393 thousand).
| PLEDGES, CONTINGENT LIABILITIES AND OTHER LIABILITIES | ||
|---|---|---|
| € 1,000 | 2018 | 2017 |
| Debts for which mortgages have been pledged | ||
| The company has not pledged any collateral. |
||
| Leasing | ||
| commitments | ||
| Payable in the next financial period | 8 | 24 |
| Payable later | 2 | |
| Total | 10 | 30 |
| Rental commitments | ||
| Payable in the next financial period | 171 | 170 |
| Payable later | 86 | 255 |
| Total | 257 | 425 |
| Other contingent liabilities | ||
| Guarantees | 4 |
Leasing and rental fees mainly consist of fixed-term leasing and rental agreements lasting longer than one year.
The company has no contingent liabilities on behalf of Group companies.
On 31 December 2018, the parent company's distributable assets (unrestricted equity) amounted to EUR 11,324,090.66, including the loss for the financial period of EUR 1,515,586.40. The Board of Directors proposes to the Annual General Meeting that the company distribute no divided for the last financial year and that the profit for the financial year be transferred to retained earnings.
Helsinki, 18 February 2019
Board of Director's proposal regarding the distribution of profits *
| Osmo Suovaniemi Chairman of the Board of Directors |
Matti Härkönen Member of the Board of Directors |
Eero Lehti Member of the Board of Directors |
|---|---|---|
| Liu Feng Member of the Board of Directors |
Franco Aiolfi Member of the Board of Directors |
|
Semi Korpela President & CEO
A statement has been issued today on the completed audit.
Helsinki, 20 February 2019
PricewaterhouseCoopers Oy Firm of auditors
Pasi Karppinen Authorised Public Accountant Auditor's Report
Biohit in brief Review by the
President & CEO Strategy and quality History Corporate governance Financial statements
To the Annual General Meeting of Biohit Oyj
In our opinion
Our opinion is consistent with the additional report to the Board of Directors.
We have audited the financial statements of Biohit Oyj (business identity code 0703582-0) for the year ended 31 December 2018.
The financial statements comprise:
We conducted our audit in accordance with good auditing practice in Finland. Our responsibilities under good auditing practice are further described in the Auditor's Responsibilities for the Audit of the Financial Statements section of our report.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
We are independent of the parent company and of the group companies in accordance with the ethical requirements that are applicable in Finland and are relevant to our audit, and we have fulfilled our other ethical responsibilities in accordance with these requirements.
To the best of our knowledge and belief, the non-audit services that we have provided to the parent company and to the group companies are in accordance with the applicable law and regulations in Finland and we have not provided non-audit services that are prohibited under Article 5(1) of Regulation (EU) No 537/2014. The non-audit services that we have provided are disclosed in note 2.10 to the Financial Statements.

President & CEO Strategy and quality History Corporate governance Financial statements

As part of designing our audit, we determined materiality and assessed the risks of material misstatement in the financial statements. In particular, we considered where management made subjective judgements; for example, in respect of significant accounting estimates that involved making assumptions and considering future events that are inherently uncertain.
The scope of our audit was influenced by our application of materiality. An audit is designed to obtain reasonable assurance whether the financial statements are free from material misstatement. Misstatements may arise due to fraud or error. They are considered material if individually or in aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of the financial statements.
Based on our professional judgement, we determined certain quantitative thresholds for materiality, including the overall group materiality for the consolidated financial statements as set out in the table below. These, together with qualitative considerations, helped us to determine the scope of our audit and the nature, timing and extent of our audit procedures and to evaluate the effect of misstatements on the financial statements as a whole.
| Overall group materiality |
€ 179 thousand |
|---|---|
| How we determined it | We used the combination of total assets and total revenues to determine overall group materiality. |
| Rationale for the materiality benchmark applied |
Biohit group's business has been clearly loss making, excluding disposal gain on Chinese joint venture in 2017. Based on our assessment a combination of total assets and total revenues provide a more solid base for determining the materiality than the commonly used benchmarks. |
We tailored the scope of our audit, taking into account the structure of the group, the accounting processes and controls, and the industry in which the group operates. Biohit Oyj is a Finnish biotechnology company operating on global markets, which has foreign subsidiaries in Great Britain and Italy.
We determined the type of work that needed to be performed at group companies. This work was performed by the group audit team. Audit was performed for the parent company and for Biohit Healthcare Ltd, UK. For the Italian subsidiary, we performed selected audit procedures on specified account balances as well as analytical procedures.
By performing the procedures above at reporting components, combined with additional procedures at the Group level, we have obtained sufficient and appropriate evidence regarding the financial information of the Group as a whole to provide a basis for our opinion on the consolidated financial statements.
Key audit matters are those matters that, in our professional judgment, were of most significance in our audit of the financial statements of the current period. These matters were addressed in the context of our audit of the financial statements as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters.
As in all of our audits, we also addressed the risk of management override of internal controls, including among other matters consideration of whether there was evidence of bias that represented a risk of material misstatement due to fraud.

Refer to the financial statements accounting principles and the financial statements note 2.3
Biohit Oyj is a Finnish Biotechnology company operating on global markets. Biohit's product portfolio consists of diagnostic tests, analysis systems, products that bind carcinogen acetaldehyde in monoclonal antibodies and service laboratory operations. The Group's revenue is predominately generated from distribution agreements signed with several distributors who then sell the products further to healthcare operators.
Revenue from distribution agreement based product sales are recognized at a point of time when control has transferred to a distributor in accordance with delivery terms. We focused in our audit on the timing of revenue recognition of distribution agreement based sales. License and service revenues are not as material from group perspective and thus auditing their revenue recognition timing were not a focus area in the audit.
In revenue recognition there is a risk that revenue in the financial statements is recognized in an incorrect period due to either errors or fraud.
We performed audit procedures relating to revenue recognition cut-off, to ensure revenue is recorded in correct period. We performed substantive audit procedures relating to timing of revenue recognition. Our substantive audit procedures included:
President & CEO Strategy and quality History Corporate governance Financial statements

Reference to the accounting principles and the financial statements note 2.17, 2.18 and 2.24
Biohit Oyj owns 18 % of Genetic Analysis AS. At the financial year-end 2018, the value of the shares is 3,9 million euros. Biohit has adopted IFRS9 standard starting from 1.1.2018. In accordance with the new standard, Genetic Analysis AS shares are classified as financial assets and are valued at fair value through other comprehensive income.
As Genetic Analysis AS is an unlisted entity, the fair value is measured using alternative information available. Due to the estimation uncertainty and significance of the investment, we have determined valuation of the Genetic Analysis AS investment to be key audit matter in the audit of the financial statements.
During 2018 we have assessed the appropriateness of the information used in determining the fair value of Genetic Analysis AS shares, specifically at the year-end. These procedures included:

Reference to the financial statements accounting principles and the financial statement notes 2.5 and 2.11
As part of disposal of Biohit HealthCare (Hefei) Co. in 2017, 7,1 million euros of intellectual property rights (patents) were recognized on the balance sheet as a result of the transaction. Balance sheet value amounts to 4,6 million euros as per December 31, 2018. The patents are amortized by the end of 2021.
The value of patents is subject to impairment testing always when there is indication of impairment. An impairment test was performed in connection with 2018 financial statements. Based on impairment test no impairment was recognized.
In the valuation of the patents there is significant management judgement involved relating to the future sales and royalties. Due to the judgement and estimation uncertainty related to the valuation of the patents, we consider this as a key audit matter for the audit of the financial statements.
This matter is a significant risk of material misstatement referred to in Article 10(2c) of Regulation (EU) No 537/2014.
We have assessed the appropriateness of the valuation of the patents at the year-end. As part of the valuation assessment we have performed the following audit procedures:
The above mentioned Key audit matter Valuation of intangible assets (patents) is also a key audit matter with respect to our audit of the parent company financial statements. The value of patents amounted to 4,6 million euros at December 31, 2018. Our audit procedures were aligned with the ones presented above. This matter is a significant risk of material misstatement referred to in Article 10(2c) of Regulation (EU) No 537/2014 also in the parent company financial statements.
The Board of Directors and the Managing Director are responsible for the preparation of consolidated financial statements that give a true and fair view in accordance with International Financial Reporting Standards (IFRS) as adopted by the EU, and of financial statements that give a true and fair view in accordance with the laws and regulations governing the preparation of financial statements in Finland and comply with statutory requirements. The Board of Directors and the Managing Director are also responsible for such internal control as they determine is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.
In preparing the financial statements, the Board of Directors and the Managing Director are responsible for assessing the parent company's and the group's ability to continue as a going concern, disclosing, as applicable, matters relating to going concern and using the going concern basis of accounting. The financial statements are prepared using the going concern basis of accounting unless there is an intention to liquidate the parent company or the group or to cease operations, or there is no realistic alternative but to do so.
Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor's report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with good auditing practice will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these financial statements.
As part of an audit in accordance with good auditing practice, we exercise professional judgment and maintain professional skepticism throughout the audit. We also:
Biohit in brief Review by the President & CEO Strategy and quality History Corporate governance Financial statements
We communicate with those charged with governance regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit.
We also provide those charged with governance with a statement that we have complied with relevant ethical requirements regarding independence, and to communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, related safeguards.
From the matters communicated with those charged with governance, we determine those matters that were of most significance in the audit of the financial statements of the current period and are therefore the key audit matters. We describe these matters in our auditor's report unless law or regulation precludes public disclosure about the matter or when, in extremely rare circumstances, we determine that a matter should not be communicated in our report because the adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such communication.
We were first appointed as auditors by the annual general meeting on 14 April 2014. Our appointment represents a total period of uninterrupted engagement of 5 years.
The Board of Directors and the Managing Director are responsible for the other information. The other information comprises the report of the Board of Directors and the information included in the Annual Report, but does not include the financial statements and our auditor's report thereon. We have obtained the report of the Board of Directors prior to the date of this auditor's report and the Annual Report is expected to be made available to us after that date.
Our opinion on the financial statements does not cover the other information. In connection with our audit of the financial statements, our responsibility is to read the other information identified above and, in doing so, consider whether the other information is materially inconsistent with the financial statements or our knowledge obtained in the audit, or otherwise appears to be materially misstated. With respect to the report of the Board of Directors, our responsibility also includes considering whether the report of the Board of Directors has been prepared in accordance with the applicable laws and regulations.
If, based on the work we have performed on the other information that we obtained prior to the date of this auditor's report, we conclude that there is a material misstatement of this other information, we are required to report that fact. We have nothing to report in this regard.
Helsinki 20 February 2019
Authorised Public Accountants
Pasi Karppinen Authorised Public Accountant (KHT)

Biohit Oyj Laippatie 1 FI-00880 Helsinki, Finland Tel: +358 9773861 [email protected]
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.