BIOHIT GROUP FINANCIAL STATEMENT RELEASE 2015

Biohit Oyj Financial Statement Release, 25 February 2016 at 9:30 am local time (EET)

SUMMARY

January–December 2015

• Net sales grew by 38.7% compared to 1-12/2014
• Net sales EUR 6.1 million (EUR 4.4 million)
• Operating loss, continuing operations, EUR -2.9 million (EUR -4.5 million)
• The result for the reporting period, continuing operations, EUR -2.9 million
  (EUR -4.4 million)
• The result for the reporting period, discontinued operations, EUR 0 million (EUR 3.3 million)
• The result for the reporting period was EUR -2.9 million (EUR -1.2 million)
• Net sales from international operations 88.3% (91.5%) of total net sales
• Equity ratio 87.9% (87.5%)

October-December / Q4 2015

• Net sales grew by 6.0% compared to Q4/2014
• Net sales EUR 1.2 million (EUR 1.1. million)
• Operating loss, continuing operations, EUR -1.4 million (EUR -1.2 million)
• The result for the reporting period, continuing operations, EUR -1.5 million
  (EUR -1.2 million)
• The result for the reporting period was EUR -1.5 million (EUR -1.2 million)
• Net sales from international operations 88.9% (92.7%) of total net sales
• Equity ratio 87.9% (87.5%)

PRESIDENT & CEO SEMI KORPELA:

‘In the fourth quarter of 2015 our net sales grew by 6.0% compared to the comparison period Q4/2014. During the entire year our net sales grew by 38.7% compared to 1-12/2014. In terms of operational development, Biohit Oyj has focused on expanding the international distributor network and supporting partners, for example in product registrations. In addition, we have focused on increasing and developing of domestic service sales as well as the commercialisation of our new products. We continued our work to increase decision-makers’, doctors’ and broader public’s awareness of acetaldehyde. Our spearhead products are Acetium, GastroPanel and diagnostic quick tests. Main market areas are Europe and Asia.

We expanded our distributor network and advanced product registrations

We continued expanding our distributor network with new agreements and by restructuring agreements. During the fourth quarter of 2015 we signed Acetium lozenge distribution agreement with Birtely Pharma (United Arab Emirates), Acetium distribution agreements with Queenslabs Lda (Portugal) and with Biomed S.A. (Spain) and ColonView distribution agreement with Zhejiang Co. Ltd (China).

In addition, during 2015 we entered among others into the following diagnostics distribution agreements: Melon OOO (Kazakhstan), Biohemed doo (Serbia, Bosnia and Herzegovina, Montenegro), Arium Sistemas de Diagnòstico Lda (Portugal), Gulf Drug LLC (United Arab Emirates), PT. InoDia (Indonesia), Mekalasi (Finland), Humasis (Korea), HealthLife (Kuwait).  We made the following agreements on Acetium product distribution: Oriola Oy (Finland), Oriola Oy (Baltic countries), LS Pharma (Italy), Daiichi Sankyo Thailand Ltd (Vietnam, Laos, Cambodia and Myanmar), El-Alawia Medical Agencies (Sudan). In addition, we expanded the distribution of Acetium lozenge to dental care in Finland by beginning a cooperation with Hammasväline Oy.

During 2015 the registration of Acetium capsule was completed in China where our partner GrandPharma will begin sales of the capsules using the Chinese brand name Shubang. The capsule binding acetaldehyde into a harmless compound was registered as a food supplement in Mexico. During the fourth quarter of 2015 the registration of Acetium capsule was completed in Nigeria and in Kuwait. The registration of the quick tests in Kuwait was also completed. In general, 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 different countries and for product sales to begin.

During 2015 a price approval decision on the three GastroPanel tests (pepsinogen l, pepsinogen II, gastrin-17) was issued in four Chinese provinces: Jilin, Liaoning, Jiangsu and Inner Mongolia. The price approval decision has already been issued in 11 provinces. Price approval is a pre-requisite for reimbursability of GastroPanel and start of sales.

We launched new products and expanded service sales

We achieved a significant milestone in R&D operations, when the development of the unified GastroPanel test was completed. GastroPanel can now be carried out more cost effectively and easily in the primary health care and screening processes.

We expanded our product portfolio with a blood sample based vitamin D test and with a quick test reader, which allows an effective use of Biohit ColonView Quick Test and Biohit Celiac Disease Quick Test in a point-of-care setting. Acetium product family grew with a new salty liquorice flavored lozenge. We also renewed the Acetium lozenge packages.

Biohit expanded pharmacy campaigns providing diagnostic testing of the gastrointestinal tract across Finland. The campaigns offer testing to enable diseases to be diagnosed and prevented at an early stage. In Helsinki the Ympyrätalo Pharmacy offers a similar service for its clients as a part of its permanent base range. We also began using an electronic appointment-booking service in Finland.

The Association for Finnish Work granted the Key Flag symbol to Acetium capsules and Acetium lozenges, indicating that the products originate from Finland.

We advanced cancer screenings in China and in Russia

We continued our work in order to improve advancements in medical practices, especially in cancer screenings. China started two gastric cancer risk screening studies using Biohit Oyj’s GastroPanel test. The first screening study is a project of the National Clinical Research Center for Digestive Diseases (Changhai Hospital), and it is funded by the Ministry of Science and Technology of China, which is the organiser of a multi-center study of early gastric cancer risk screening. In the study at least 20,000 persons will be screened in approximately 50 hospitals. The screenings are set to end in December 2016.

The second study is being conducted in Chinese healthcare centers by the China Health Promotion Foundation. The foundation is a public organisation, managed by the Chinese Ministry of Health. Around half a million 40-80-year-old asymptomatic persons will be screened in the study. The sample collection has begun in the summer of 2015.

Russian Federation started a pilot project for colorectal cancer screening, targeted to 48-75-year-old asymptomatic persons. In the project around 20,000 persons will be screened. A screening test will be selected for the project, based on the results of the study. Biohit Oyj’s ColonView test is one of the options.  The screening project is organised and sponsored by the Russian Federal Government and it will be performed in local medical clinics.

We made progress in our clinical studies

The first, nearly two-year smoking intervention study by Biohit Oyj was completed in November 2015. According to some preliminary observations, the Acetium lozenge containing slowly releasing L-cysteine is a promising novel method to assist in smoking cessation. This is a new significant indication of the possible benefit of the product in addition to that it has no side effects such as with medication and nicotine products, and it binds acetaldehyde dissolved into saliva from cigarette smoke to form a harmless compound and promote oral health.

Research results related to acetaldehyde and cancer screenings supported our operations

The research results related to carcinogenic acetaldehyde and cancer screenings underlined the importance of our offering as part of the prevention and early diagnosis of socially important major diseases, especially of ageing population, and thereby saving costs.

An international study comparing colorectal cancer screening tests was completed. The results indicated that Biohit Oyj’s ColonView, specific for human blood, is superior to the conventional tests in colorectal cancer screening due to its sensitivity and specificity. The scientific report was published in an international cancer journal Anticancer Research.

In the Congress of the European Society for Biomedical Research on Alcoholism (ESBRA), a new study was introduced assessing the effect of Acetium lozenges on salivary acetaldehyde concentrations after consuming alcoholic beverages containing high and low levels of acetaldehyde. Promising results were gained with Acetium lozenge in the elimination of carcinogenic acetaldehyde in saliva.

The results of the Japanese–Finnish study were published in PLOS ONE journal. According to the study, acetaldehyde is a major pathophysiological factor in gastric carcinogenesis. According to Professor of Internal Medicine, Gastroenterology and Alcohol Research, Helmut K. Seitz, University of Heidelberg, the study shows for the first time the role of acetaldehyde in gastric cancer. 

Acetium is used in a Japanese cancer study. According to Professor Katsunori Iijima, Chief of Gastroenterology Department from Akita University hospital, the product can be a significant way to prevent cancer. In his new studies, he will assess the effect of Acetium on acetaldehyde concentrations in esophageal and gastric mucosa as well as its possible role in prevention of recurrent cancer among these high-risk patients. Professor Iijima’s team will use also GastroPanel test developed by Biohit Oyj to estimate the cancer risk in these patients.

Awareness of acetaldehyde increased

The motion of the European Parliament´s committee on Environment, Public Health and Food Safety (ENVI) was accepted in May 2015, containing key elements regarding acetaldehyde. In the motion European Parliament urged the Commission to immediately ask the European Food Safety Authority (EFSA) to re-evaluate the use of acetaldehyde as a flavoring substance in alcoholic and non-alcoholic beverages.

MEPs Against Cancer, an informal group of Members of the European Parliament committed to actions against cancer, held an expert consultation about alcohol and cancer. Experts were present from European cancer organisations’ umbrella organisation European Cancer League and from European Alcohol Policy Alliance Eurocare that coordinates alcohol policy in the member states of the European Union. The expert consultation was held due the European Parliament Motion for a resolution on Alcohol Strategy in which acetaldehyde was featured.

In the light of the existing knowledge, the packaging of alcoholic drinks should contain a statement on its possible content of acetaldehyde, which is classified by the WHO as carcinogenic to humans. Given that there is no scientific evidence to indicate that the acetaldehyde and ethanol in the foodstuffs are less carcinogenic than the acetaldehyde in alcoholic beverages, the same requirements should also apply to these products. In 2012, an expert panel set up by the EU proposed that the acetaldehyde content of cosmetic products should not exceed 5mg/l, and mouthwashes should not contain any acetaldehyde. Several foodstuffs have an acetaldehyde content in excess of 5mg/l'. (http://www.biohithealthcare.com/laboratory-services/determination-of-acetaldehyde)

THE GROUP’S KEY FIGURES

REPORTING

Biohit's product portfolio consists of diagnostic tests, analysis systems, products binding carcinogenic acetaldehyde into a harmless compound, monoclonal antibodies and service laboratory operations. The entire product and service portfolio is reported under a single segment.


NET SALES AND RESULT

January-December

Net sales grew by 38.7% compared with 1-12/2014.

The operating loss from continuing operations was EUR -2.9 million (EUR -4.5 million 1-12/2014). The result for continuing operations during the reporting period totalled EUR -2.9 million (EUR -4.4 million).

The result for discontinued operations totalled EUR 0.0 million (EUR 3.3 million). In conjunction with the liquid handling business divestment in late 2011, EUR 3.5 million of the gains on sale were not recognised due to the terms of the sale agreement and other factors, related to the sale, which remained open at the time. The amount was recognised on 31 March 2014 when the deal was closed.

The result from continuing operations for the reporting period was EUR -2.9 million (EUR -4.4 million).

Consolidated net sales and result for continued operations

BALANCE SHEET

On 31 December 2015, the balance sheet total was EUR 11.7 million (EUR 14.5 million). Biohit's balance sheet provides a solid foundation for building new business and for fully utilising the significant potential offered by the company's products. At the end of 2015, our equity ratio stood at 87.9% (87.5%).

                                                                               
FINANCING

Biohit Oyj has a good financial position, which allows investments in an international distributor network as well as the development and commercialisation of new products. Liquidity is at a healthy level. At the end of the reporting period, the company's financial assets totalled EUR 7.2 million (EUR 10.4 million).

RESEARCH AND DEVELOPMENT

R&D operations focuses on innovations, as well as product development and 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 1-12/2015 reporting period amounted to EUR 2.0 million (EUR 2.1 million), of which the final quarter accounted for EUR 0.5 million (EUR 0.6 million).

Development activities focused on the GastroPanel Unification Project, which improved the usability of the test. The unified GastroPanel test kit was completed in September. In addition, we developed and launched new products. During 2015 we launched the ELISA-test for the measurement of vitamin D level from a blood sample (BIOHIT Total25OH vitamin D) and a quick test reader to assist the evaluation of the ColonView and Celiac Disease Test results.
 

CLINICAL RESEARCH

During 2015 some twenty clinical trials were ongoing in Finland and abroad with Biohit’s diagnostic tests and Acetium products.

An international study comparing colorectal cancer screening tests was completed in the beginning of 2015. The results indicated that Biohit ColonView is superior to the conventional tests in colorectal cancer screening due to its sensitivity and specificity. The study compared two colorectal cancer screening tests based on the detection of fecal occult blood (FOB) in stool samples. A cohort of 300 patients, all referred for colonoscopy, were examined using the new-generation Biohit ColonView fecal immunochemical Test (FIT) and a conventional FOB test. The modern ColonView Quick Test detects both hemoglobin (Hb) and hemoglobin-haptoglobin (Hb/Hp) complex, whereas the conventional FOB test is only for the detection of Hb. The scientific report of the study was published in an international cancer journal Anticancer Research. A study with a similar design but larger series of patients is progressing well in a major cancer center in Brazil.   

Another major highlight in Biohit Oyj’s Clinical Research was the conclusion of the smoking intervention study initiated in 2013, assessing the efficacy of the slowly releasing L-cysteine contained in Acetium lozenge as a novel method to assist smoking cessation. According to some preliminary observations, the Acetium lozenge is a promising novel method to assist in smoking cessation. The efficacy in smoking cessation favorably competes with most of the currently used smoking intervention methods (ia. nicotine replacement therapy or medications). Unlike commonly used current intervention methods, the Acetium lozenge has no side effects or restrictions for use. Great expectations are put in the future this indication, representing conceptually an entirely novel method of smoking intervention. The clinical part of the study was concluded in the beginning of November 2015, followed by submission of the scientific report to a major international journal in December. If the efficacy can be confirmed in adequately powered study (approximately a cohort of 1500 smokers) this new approach represents a breakthrough in the development of smoking intervention methods.

An international project determining the prevalence of latent B12 vitamin deficiency and its causes, atrophic gastritis, among over 75-year-olds is ongoing. The determination is carried out with Biohit’s GastroPanel and B12 vitamin test. The clinical part of the project was completed in Finland during 2015. The results show that the commonness of latent B12 vitamin deficiency among the elderly is at estimated level. At the same time the results indicate that serious complications could be prevented with early diagnostics and an appropriate substitution treatment.

As to the other ongoing research projects, the most advanced ones are the two randomised, double-blind trials, where the effect of Acetium capsule is assessed as a new method of prevention of migraine and cluster headaches. Both are multi-center trials and have been in progress since 2014 in six centers around Finland.

In addition, a study testing CeliacDisease Quick Test in pediatric patients is conducted in a children’s hospital in Romania, aiming to enroll a cohort of 100 study subjects.

Towards the end of 2015, the arrangements were completed to start a major clinical trial with the unified GastroPanel test, validating the new test in gastroscopy referral patients at GastroCenter of Oulu University Hospital. Included will be all patients referred for gastroscopy from the primary health care during one year period. i.e. close to 2000 patients. Once completed, this extensive study will provide the reference material for the new GastroPanel test, including the accurate cut-off values for the different diagnostic categories in a representative Finnish population.    

Also, a study testing the efficacy of Acetium capsule in the treatment and recovery of atrophic gastritis in a double-blind, placebo-controlled setting is ongoing. The study is conducted in two leading gastroenterology clinics in Italy (Bologna and Parma). The start of this study was delayed because of the long lasting approval process. The final results are expected after two years, because of the nature of the trial, with prolonged follow-up period needed to confirm the long-term treatment effect.

Acetium capsules’ acetaldehyde-binding properties have been studied in a trial conducted in Sweden, which confirms the earlier scientific results related to Acetium. The study showed that Acetium binds 60–80% of the group I carcinogenic acetaldehyde and creates a harmless MTCA compound that clears from the body. The report is under an evaluation in an international scientific journal. 
 

INVESTMENTS

Gross investments during the 1-12/2015 reporting period totalled EUR 0.2 million (EUR 0.5 million), of which the fourth quarter accounted for EUR 0.0 million (EUR 0.2 million). Key investments in the period were related to production automation-related equipment.

PERSONNEL

During the review period, the Biohit Group employed 52 (50 in 2014) people on average, 44 (41) of whom were employed by the parent company and 8 (9) by the subsidiaries. At the end of the year 2015, the Group employed 49 (51) personnel, of whom 40 (42) were employed by the parent company and 9 (9) by the subsidiaries.

SHORT-TERM RISKS AND UNCERTAINTY FACTORS

Biohit’s key risks have to do with the investments required for business growth and adequacy of economic resources these require in the medium term. There are risks involved in areas such as the success of clinical trials, the selection and development of new market areas and distribution channels, personnel recruitment, registration processes, product pricing, 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 recent increase in uncertainty factors associated with international politics may have an unfavorable 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. Biohit conducts its investment activities with at least two partners.

Thanks to its wide customer base, Biohit does not materially depend on any individual customers or project deliveries, with the exception of GastroPanel sales in China, which currently represents a major business for Biohit. Most of the company’s business is conducted in euro, and the indirect effects of currency exchange rate fluctuations are considered minor.

OUTLOOK FOR 2016

Together with its distributors and license partners, Biohit has several product registrations ongoing in a number of markets, which is affecting net sales development.   A number of such registrations are expected to be completed in 2016. In addition, negotiations are in progress with new partners, including on the launch of major screening projects, but a number of political risks are affecting the progress of such projects.

Biohit's cost structure is characterised by high investment in research to obtain further evidence on the efficacy of Biohit's diagnostic tests in various clinical settings and in population-based screenings.  In 2015 Acetium double-blind study assessing the efficacy of the product in new indications was completed. These studies will be continued also in 2016. The unification project of the GastroPanel test and production investments in Finland were concluded in 2015. These, strategically significant projects will require significant additional investments in 2016.

Biohit Biotech (Hefei) Co Ltd is expected to start production in 2016. The factory is currently producing validation batches in accordance with the requirement of authorities and after approval the factory can start producing GastroPanel kits for the Chinese market. The company has also started recruitment of sales personnel.

We aim to grow profitable and are strongly committed to taking necessary actions in order to build a profitable future for the company. Net sales growth is expected in 2016. The company does not assess when the result of its continuing operations will turn to positive.

BOARD’S PROPOSAL FOR DISTRIBUTIONS OF PROFIT

The parent company's distributable funds (unrestricted equity) on 31 December 2015 are
6,079,716.06, of which the period net loss is 3,526,862.99. The Board of Directors proposes to the Annual General Meeting that no dividend be paid for the financial year.

MAIN EVENTS IN THE FOURTH QUARTER

Vitamin D test to complement the diagnostics for osteoporosis and bone fracture prevention

Biohit Oyj launched a new test for determination of vitamin D from blood samples. The concentration of 25-OH vitamin D in blood is so far the easiest and most reliable indicator of biologically active vitamin D levels. Serum 25-OH vitamin D levels reflect the total vitamin D storage of the body and also correlate with the clinical symptoms of vitamin D deficiency. An adequate intake of vitamin D helps keeping the bones healthy, as it is the single most important factor regulating the calcium and phosphate absorption.

Acetium lozenge – a promising novel method to assist smoking cessation

The first, nearly two-year smoking intervention study with Acetium lozenge by Biohit Oyj was concluded. According to some preliminary observations, the Acetium lozenge is a promising novel method to assist in smoking cessation. This was a significant new indication of the product in addition to its ability to bind carcinogenic acetaldehyde dissolved into saliva from cigarette smoke to form a harmless compound and thereby promote oral health.
 

Colorectal screening project started in Russia with Biohit Oyj’s ColonView test

Russian Federation started a pilot project for colorectal cancer screening, targeted to 48-75-year-old asymptomatic persons. In the project around 20.000 persons will be screened. A screening test will be selected for the project, based on the results of the pilot phase. Biohit Oyj’s ColonView test is one of the options.  After this, the project will last six years and will include all 18 districts of Saint Petersburg. The screening project is organised and sponsored by the Russian Federal Government and it will be performed in local medical clinics.

Acetium® is used in a Japanese cancer study – according to Professor Katsunori Iijima, the product can be a significant way to prevent cancer

Professor Katsunori Iijima. Chief of Gastroenterology Department from Akita University hospital (Japan) believes that Biohit Oyj’s Acetium-products containing slow-release L-cysteine might offer a new means to prevent esophageal and gastric cancers. Professor Iijima visited Biohit Oyj in November to introduce his planned new studies. In his new studies, he will assess the effect of Acetium on acetaldehyde concentrations in esophageal and gastric mucosa as well as its possible role in prevention of recurrent cancer among these high-risk patients. Professor Iijima’s team will use also GastroPanel test developed by Biohit Oyj to estimate the cancer risk in these patients.
 

Biohit Oyj’s Management Team Option Arrangement

Biohit Oyj’s Board of Directors decided to distribute in total 60,000 option rights in class I 2013C of the option scheme I 2013 to the members of the company’s management team excluding the CEO as follows: Hendolin Panu 15,000 pcs, Nordström Niklas 15,000 pcs, Mickels Anu 15,000 pcs and Astola Annika, 15,000 pcs. Each option right entitles its holder to subscribe for one (1) of the company’s new class B-shares. Share subscription price is 2.2766 euros. The subscription price can be amended pursuant to the terms and conditions of the option scheme.
 

Biohit Oyj changed its financial reporting – in the future, the company will publish financial reviews twice a year

Biohit Oyj’s board decided in the final meeting of the year that the company will change its financial reporting schedule from the beginning of 2016. In the future, Biohit Oyj will publish financial reviews twice a year. This was a change to the previously published schedule (4.12.2015 Biohit's Financial Reporting and Annual General Meeting in 2016). Biohit Oyj will publish the Financial Statement Release for 2015 on Thursday 25th of February 2016, the Annual Report, including financial statements for 2015 and the Report of the Board of Directors, approximately during week 12 and the Half-year report for period January - June 2016 (Q2) on Thursday 18th of August 2016.

MAJOR EVENTS AFTER THE CLOSE OF THE PERIOD

Biohit Oyj bought a share of Norwegian Genetic Analysis AS company with a directed share issue

Biohit Oyj and Genetic Analysis AS signed a share exchange agreement through which Biohit Oyj acquired ownership of 18% of shares in the company. In addition to this the companies signed a distribution agreement giving Biohit Oyj a right to sell Genetic Analysis AS’s Dysbiosis Test globally under the Biohit brand and exclusively in Finland and in China. In the future, Genetic Analysis will also operate as a distributor to Biohit Oyj’s products and services in Norway.

In consideration, Biohit Oyj issued 350.000 pcs of new Biohit Oyj’s series B shares to Genetic Analysis AS. The new class B shares were registered with the Trade Register on February 12, 2016, and the shares carry with them the same shareholder rights as the outstanding class B shares as of the date of the registration. The trading in the new shares commenced as of February 15, 2016 on NASDAQ OMX Helsinki together with the outstanding B shares. The arrangements related to the share exchange have been completed and the new Genetic Analysis AS shares have been registered in Biohit Oyj’s name.

Biohit Oyj started a confirmatory smoking intervention trial

Biohit Oyj started a confirmatory clinical trial for smoking intervention in cooperation with research agency Kuulas Helsinki.  The aim of the study is to confirm the promising results obtained in the previous clinical trial aimed at smoking cessation. If successful, the trial gives adequate power to confirm, that the Acetium lozenge is a breakthrough in the development of smoking intervention methods. A cohort of 1,800 voluntary smokers will be invited to the new study. The study has been started and is expected to be completed during 2016.

ADMINISTRATION

Biohit's financial reporting and Annual General Meeting in 2016

Biohit Oyj’s Annual General Meeting has been planned for 3.00 pm on Monday 25 April 2016 in Helsinki. The Board of Directors will call the General Meeting at a later date. In 2016 the company will publish the half-yearly report for period January - June 2016 (Q2) at 9:30 am on Thursday 18 August 2016.

Biohit Oyj's Management Team

The members of Biohit's Management Team are: CEO Semi Korpela, CFO Niklas Nordström, Director of Business Development Lea Paloheimo, Production & Research and Development Director Panu Hendolin, Sales and Marketing Director Anu Mickels, Quality Director Annika Astola and Chief Medical Director Kari Syrjänen.
 

SHARES AND SHAREHOLDERS

Biohit Oyj’s number of shares is 14,348,533 (14,135,593), of which 2,975,500 (2,975,500) are Series A shares and 11,373,033 (11,160,093) 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 80.5 million (EUR 66.2 million on 31 December 2014). Shares’ trade value during the period amounted to EUR 22.6 million.

Shareholders

At the end of the reporting period on 31 December 2015, the company had 6,594 shareholders (6,841 on 31 December 2014). Private households held 78.0% (77.9%), companies 20.1% (20.1%) and public sector organisations 0.0% (0.0%). Foreign ownership or nominee registrations accounted for 1.7% (1.8%) of shares.

Further information on the shares, major shareholders and management shareholdings is available on the company's website at www.biohithealthcare.com/investors.

ACCOUNTING PRINCIPLES

This financial statement release has been prepared in accordance with the requirements of the IAS 34 Interim Financial Reporting standard. Biohit Oyj has applied the same accounting principles in preparing this financial statement release as for its financial statements 2015.

Joint control in accordance with the IFRS 10 standard fulfilled on part of Biohit Biotech (Hefei) Co. Ltd. on 30th September 2015 in the way referred to in the standard and the shareholders’ agreement and the investment is therefore presented in the balance sheet drawn up according to the new standards and consolidated in Biohit’s consolidated financial statements using the equity method. The consolidation had a nonrecurring effect of EUR 0.7 million on the operating income. Biohit Oyj’s share of the joint venture’s profit/loss is reported above operating profit.

The figures in the financial statement release have not been audited.

CONSOLIDATED INCOME STATEMENT

Earnings per share calculated from earnings attributable to equity holders of the parent company

CONSOLIDATED BALANCE SHEET

STATEMENT OF CHANGES IN EQUITY

Consolidated statement of changes in equity on 31 December 2015

Consolidated statement of changes in equity on 31 December 2014

CASH FLOW STATEMENT

RELATED PARTY TRANSACTIONS

During the fourth quarter, there were no notable changes in related party transactions.

Biohit Oyj B-shares subscribed with stock options I and II 2013 during the 1-12/2015 reporting period

A total of 32,940 new Biohit Oyj B-shares were subscribed for with stock options I 2013 during 2015, and at total of 180,000 new Biohit Oyj B-shares were subscribed for with stock options II 2013. These shares have been entered into the trade register and establish equal shareholder rights with the company's existing B-shares. New shares’ are subject to public trading on the NASDAQ Helsinki together with the existing B-shares.

The share subscription price for the stock options in question was EUR 2.2766 per share. The entire subscription price was EUR 74,991.20 for the I 2013 option scheme and EUR 407,788 for the II 2013 option scheme, totalling EUR 484,779.2. The amount was entered in the invested non-restricted equity fund and the company share capital remains unchanged. The shares have no nominal value.

After the 2015 subscription (212,940 shares), the total number of Biohit Oyj's shares increased to 14,348,533 (14,135,593 shares December 31, 2014) and B-shares to 11,373,033 (11,160,093 shares December 31, 2014). The new shares will correspond to a percentage of 1.48% of Biohit Oyj's total number of shares and 0.30% of the voting rights after registration.

The share subscription period for stock options I 2013 began on 1 June 2014 and will end on 31 May 2019. The share subscription period for stock options II 2013 began on 1 July 2013 and ended on 30 June 2015. These schemes are based on the Biohit Oyj board resolution of 19 June 2013 and the Annual General Meeting authorisation of 13 April 2011. The terms and conditions of the option schemes and additional information are available on Biohit Oyj's website at www.biohithealthcare.com.

To exercise their stock options, holders of stock options must have paid the subscription price in accordance with the option scheme. Holders exercising their stock options are liable to pay income tax on the stock option income.
 

COLLATERAL, CONTINGENT LIABILITIES AND OTHER COMMITMENTS  

NEXT FINANCIAL REPORT

The half-yearly report for January - June 2016 (Q2) will be published at 9:30 am local time (EEST) on Thursday 18 August 2016.

Helsinki, 25 February 2016

Biohit Oyj
Board of Directors

Additional information:
CEO Semi Korpela
tel. +358 9 773 861
investor.relations@biohit.fi
www.biohithealthcare.com
 

Biohit in brief

Biohit Oyj is a globally operating Finnish biotechnology company. Biohit mission is “Innovating for Health” – we produce innovative products and services to promote research and early diagnosis. Biohit is headquartered in Helsinki, Finland, and has subsidiaries in Italy and the UK. Biohit Series B share (BIOBV) is quoted on Nasdaq Helsinki in the Small cap/Healthcare group. www.biohithealthcare.com

Additional Information.pdf