Biohit Oyj Financial Statement Release, 20 February 2019 at 9:30 am local time (EET)


SUMMARY

January-December 2018

  • Net sales EUR 9.9 million (EUR 9.0 million)
  • Net sales grew by 10.6% compared to 2017
  • Operative EBITDA EUR -0.1 million (EUR -0.4 million)
  • Cash at the end of the period EUR 1.4 million (EUR 1.3 million)
  • Net sales from international operations 95.6% (95.7%) of total net sales
  • Equity ratio 89.2% (91.3%)

July-December 2018

  • Net sales EUR 5.0 million (EUR 4.9 million)
  • Net sales grew by 2.0% compared to H2/2017
  • Operative EBITDA EUR 0.0 million (EUR 0.3 million)
  • Cash at the end of the period EUR 1.4 million (EUR 1.3 million)
  • Net sales from international operations 94.0% (96.2%) of total net sales
  • Equity ratio 89.2% (91.3%)

Biohit Group presents certain alternative performance measures (APM) to reflect the underlying business performance and to enhance comparability between financial periods. Alternative performance measures should not be considered in isolation as a substitute for measures of performance in accordance with IFRS. Definitions and reconciliation of key figures are presented in the financial section of the release.

PRESIDENT & CEO SEMI KORPELA:

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.

New products and patents with increased social responsibility

Biohit has made several innovations in last 30 years and taken significant social responsibility in developing preventive healthcare. 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 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 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, 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.

Expansion of our distribution network continued

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 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.

Changes regarding China

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.

Our research projects

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.

BIOHIT GROUP KEY FIGURES

  7-12/2018 7-12/2017 1-12/2018 1-12/2017
Net sales (MEUR) 5.0   4.9   9.9   9.0  
EBITDA (MEUR) 0.0   0.3   -0.2   7.9  
Operative EBITDA (MEUR) 0.0   0.3   -0.1   -0.4  
Operating profit/loss (MEUR) -1.0   -1.0   -2.0   6.4  
Profit/loss before taxes (MEUR) -1.0   -1.0   -2.0   6.4  
Profit/loss for the period (MEUR) -1.1   -1.1   -2.1   6.1  
Average number of personnel 50   51   50   51  
Number of personnel at the end of the period 49   51   49   51  
Equity ratio (%) 89,2 % 91,3 % 89,2 % 91,3 %
Earnings per share (EUR), Undiluted -0.07   -0.07   -0.14   0.42  
Earnings per share (EUR), Diluted -0.07   -0.07   -0.14   0.41  
Shareholders' equity per share (EUR) 1.06   1.16   1.06   1.16  
Average number of shares during the period 14,915,265   14,810,689   14,901,904   14,764,411  
Number of shares at the end of the period 14,952,041   14 886,843   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.

REPORTING

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 AND RESULT

January-December

Net sales grew by 10.6% from the previous year. Operative EBITDA was EUR -0.1 million (EUR -0.4 million).

The operating loss was EUR 2.0 million (profit EUR 6.4 million). The loss for the reporting period was EUR 2.1 million (profit EUR 6.1 million).

Consolidated net sales and operating profit

  7-12/2018 7-12/2017 Change 1-12/2018 1-12/2017 Change
Net sales MEUR 5.0   4.9   0.1 9.9   9.0   1.0
Change compared to the previous year (%) 2.0 % 12.0 %   10.6 % 9.6 %  
Operating income MEUR -1.0   -1.0   0.0 -2.0   6.4   -8.3
Operating income
(% of net sales)
-20.4 % -20.8 %   -19.8 % 70.8 %  

ALTERNATIVE PERFORMANCE MEASURES

Bridge calculation of operative EBITDA

EUR million 7-12/2018 7-12/2017 1-12/2018 1-12/2017
Operating profit/loss -1.0 -1.0 -2.0 6.4
Depreciation and amortization 1.0 1.3 1.8 1.6
IFRS 2 Share based payments   0.0 0.0 0.1
Share of profit/loss in Biohit HealthCare (Hefei) Co. Ltd (profit - / loss +)       -0.2
Profit from sale of share in Biohit HealthCare (Hefei) Co. Ltd       -8.2
Operative EBITDA 0.0 0.3 -0.1 -0.4

BALANCE SHEET

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%).

FINANCING AND OPERATIONAL CONTINUITY

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. 

RESEARCH AND DEVELOPMENT

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 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.

CLINICAL RESEARCH

Clinical studies progressed and some were completed

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. Enrollment of the patients in the study has been augmented substantially after spreading the information about the study to outside-hospital targets, by repeated announcements in the local newspaper and one in the Diabetes-journal. At this writing, more than 200 DM1/AITD patents have been enrolled, with their GastroPanel samples delivered to analysis at Biohit laboratory.

INVESTMENTS

Gross investments during the 1-12/2018 reporting period totalled EUR 0.0 million (EUR 0.2 million).


PERSONNEL

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.

SHORT-TERM RISKS AND UNCERTAINTY FACTORS

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.

OUTLOOK FOR 2019

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.

BOARD’S PROPOSAL FOR DISTRIBUTIONS OF PROFIT

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.


MAIN EVENTS IN THE SECOND HALF OF THE YEAR (H2)

Retail Partner ApS to distribute Acetium® lozenge in Denmark and Sweden

Biohit Oyj and Retail partner ApS signed an agreement for the distribution of the smoking cessation product Acetium lozenge in Denmark and Sweden.

Changes to Biohit Oyj’s management

Adjunct professor (molecular mircobiology) and computer science engineer Minna Mäki (b. 1969) was appointed R&D and production director and as a member of the Management Team of Biohit Oyj starting July 30th 2018. Mäki will report to CEO Semi Korpela.

Decisions of the Extraordinary General Meeting of Biohit Oyj

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). 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 the Annual General Meeting.

The results of the migraine study was delayed from the previously reported schedule

The results of the migraine study was delayed. The final results will not be available until the first reporting period of 2019.

Stina Syrjänen resigns from Biohit Oyj’s Board of Directors 16.10.2018

Stina Syrjänen resigned from the Biohit Oyj’s Board of Directors. The resignation was effective immediately.

Chief Medical Director Kari Syrjänen retired from Biohit Oyj

Biohit’s management team member Chief Medical Director Kari Syrjänen retired as planned 31st of December 2018.

MAIN EVENTS AFTER THE CLOSE OF THE REVIEW PERIOD

Biohit new-generation fecal immunochemical test (ColonView-FIT) is superior to traditional guaiac test in colorectal cancer screening

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.

Business Development Director Lea Paloheimo retired from Biohit Oyj

Biohit’s management team member Business Development Director Lea Paloheimo retired as planned 31st of January 2019.

International group of experts revisited the value of traditional Helicobacter tests (13C urea breath test and stool antigen test) in their critical review

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.

ADMINISTRATION

Biohit's financial reporting and Annual General Meeting in 2019

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. In 2019 the company will publish the half-year financial report for period January - June 2019 (H1) at 9:30 am on Wednesday 14 August 2019.

Biohit Oyj's Management Team

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.

SHARES AND SHAREHOLDERS

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).

BIOBV/NASDAQ OMX Helsinki 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

Shareholders

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 .


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 2017 except 2018 implemented IFRS standard changes and interpretations. Additional information of IFRS 9 and IFRS 15 implementations has been presented in this financial statement release. Other changes in IFRS standards and interpretations has no material impact in this financial statement release. The figures in the financial statement release have not been audited.

Alternative performance measures

The new guidance regarding alternative performance measures (APM) by the European Securities and Markets Authority, ESMA, came into effect in 2016. Biohit Group presents certain alternative performance measures to reflect the underlying business performance and to enhance comparability between financial periods. Alternative performance measures should not be considered in isolation as a substitute for measures of performance in accordance with IFRS. Operative performance measures have been adjusted for certain non-operative items or non-cash valuation items that affect comparability between periods.

Items affecting comparability:

Certain items that are not related to the underlying business or non-cash valuation items that have material effect on the profit and loss for the period are adjusted as items affecting comparability. These items can arise for example from:

- Impairment of assets

- Sale or acquisition of asset or business

- Share based payment expences in accordance with IFRS 2

Additionally Biohit Oyj presents the following alternative performance measures:

EBITDA EBIT + depreciation and amortization
Operative EBITDA EBIT + depreciation and amortization – Items affecting comparability



IFRS 9 Financial Instruments:

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.

The group has reviewed its financial assets and liabilities. The adoption of the new standard has following impact:

Biohit classifies and measures its financial assets according to the following three categories: amortised cost, fair value through other comprehensive income and fair value through profit or loss. Classification of financial assets is driven by the business model and the contractual cash flow characteristics of the financial assets at initial recognition. Financial assets at amortised cost include cash and cash equivalents and trade and loan receivables. The adoption of the new classification model for the financial assets did not have any impact on the carrying amounts.

Equity investments are measured at fair value. The changes of fair value are recognised through profit and loss unless the group has designated the equity investment as at fair value through other comprehensive income. Biohit recognises fair value changes only from the investment in Genetic Analysis AS through other comprehensive income.

In addition, money market investments are measured at fair value through profit or loss.

Adoption of IFRS 9 does not have impact on the measurement of the group’s financial liabilities.

Under IFRS 9, impairment is recognised based on the expected credit losses. Biohit applies simplified approach to recognising expected credit losses on trade receivables. The group uses a provision matrix to calculate the expected credit losses on all trade receivables.

The group does not apply hedge accounting currently and therefore the hedge accounting requirements do not have impact on the financial statements.

The standard was applied first time at 1 January 2018. The financial instruments of the Group were following:

Financial Instruments reclassification followed by IFRS 9 adoption IAS 39 Measurement Category IFRS 9 Measurement Category Carrying amount MEUR IAS 39 Carrying amount MEUR IFRS 9 Change
Current assets
Other current financial assets Available-for-sale financial assets Fair value through profit and loss 4.3 4.3  
Other current financial assets Available-for-sale financial assets Fair value through other comprehensive income 3.1 3.1  
Trade receivables Loans and receivables Amortized cost 1.6 1.6  
Other receivables Loans and receivables Amortized cost 0.3 0.3  
Cash and cash equivalents Loans and receivables Amortized cost 1.3 1.3  

IFRS15 Revenue from Contracts with Customers 

The Group implemented IFRS 15 Revenue from contracts with customers on 1 January 2018. The new standard establishes a five-step guidance for recognizing revenue from contracts with customers and it replaced revenue standards IAS 18, IAS 11 and the related interpretations.

Biohit implemented IFRS 15 standard with modified retrospective method where the cumulative effect of initially applying the Standard, to contracts for which all of the goods or services had not been transferred, is recognized to the opening balance of retained earnings. Due to the modified retrospective method Biohit did not restate comparatives. Implementing the standard did not affect equity or revenue recognition practices.

Group’s revenue consists of sale of goods, laboratory services and royalties. The goods sold comprise of diagnostic tests, products that bind acetaldehyde, analysis systems and monoclonal antibodies. Biohit recognizes revenue from goods, laboratory services and licensing business’ royalties as separate performance obligations as customers can benefit from those separately. Determining transaction price is mainly straightforward as contracts include fixed unit prices and transaction price is not adjusted for effects of time value of the money. Biohit has no variable considerations such as rebates except for rights of return related to certain contracts. Revenue is recognized at a point in time when control is transferred to customer i.e. when the goods are delivered or when the samples have been analyzed, except for royalties. Royalties are recognized as so called subsequent sale occurs i.e. based on customer entity’s revenue arisen from sale of the licensed goods or based on sold amounts.

NET SALES BY MARKET AREA

EUR million
    2018 2017
Finland     0.4 0.4
Europe, other     3.6 3.0
North and South-America     0.2 0.2
Asia     4.7 4.6
Other countries     1.0 0.8
Net Sales from contracts with customers total     9.9 9.0

CONSOLIDATED INCOME STATEMENT

EUR million 7-12/2018 7-12/2017 Change 1-12/2018 1-12/2017 Change
Net sales 5.0 4.9 0.1 9.9 9.0 1.0
Change in investories of finished goods and work in progress 0.3 -0.2 0.4 0.1 -0.1 0.3
Other operating income 0.0 0.0 0.0 0.0 8.3 -8.2
Materials and services -2.0 -1.8 -0.2 -3.6 -3.2 -0.4
Employee benefit expenses -1.6 -1.6 0.0 -3.3 -3.4 0.1
Other operating expenses -1.8 -1.2 -0.6 -3.3 -2.7 -0.6
Share of profit/loss in Joint Venture     0.0   0.2 -0.2
EBITDA 0.0 0.3 -0.3 -0.2 7.9 -8.1
Depreciation and amortization -1.0 -1.3 0.3 -1.8 -1.6 -0.2
Operating profit/loss -1.0 -1.0 0.0 -2.0 6.4 -8.3
Financial income 0.1 0.1 0.0 0.2 0.1 0.0
Financial expenses -0.1 -0.1 0.1 -0.2 -0.1 -0.1
Profit/loss before taxes -1.0 -1.0 0.0 -2.0 6.4 -8.4
Income taxes -0.1 -0.1 0.0 -0.1 -0.3 0.1
Profit/loss for the financial period -1.1 -1.1 0.0 -2.1 6.1 -8.3
Items of comprehensive income that may later be reclassified through profit or loss            
Translation differences 0.0 0.0 0.0 0.0 0.0 0.0
Items that will not be reclassified to profit or loss            
Changes in the fair value of equity investments measured at fair value through other comprehensive income 0.0 -0.1 0.1 0.6 -0.1 0.7
Other comprehensive income total 0.0 -0.1 0.1 0.6 -0.2 0.8
Comprehensive income for the period -1.1 -1.2 0.1 -1.5 6.0 -7.5

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

  1-12/2018 1-12/2017
Undiluted earnings per share, (EUR) -0.14 0.42
Diluted earnings per share, (EUR) -0.14 0.41


CONSOLIDATED BALANCE SHEET   
EUR million 31.12.2018 31.12.2017
ASSETS    
NON-CURRENT ASSETS    
Intangible assets 5.0 6.8
Property. plant and equipment 0.6 0.7
Other financial long-term assets 0.0 0.0
Deferred tax assets 0.1 0.1
Total non-current assets 5.7 7.5
    
CURRENT ASSETS    
Inventories 0.8 0.7
Trade and other receivables 2.0 2.0
Other current financial assets 8.0 7.4
Cash and cash equivalents 1.4 1.3
Total current assets 12.2 11.4
     
TOTAL ASSETS 17.9 18.9
     
SHAREHOLDERS' EQUITY AND LIABILITIES    
Shareholders' equity attributable to the owners of the parent company    
Share capital 2.4 2.4
Invested unrestricted equity fund 4.9 4.8
Translation differences -0.1 -0.1
Retained earnings 8.8 10.3
Total shareholders' equity 15.9 17.2
     
   
NON-CURRENT LIABILITIES    
Deferred tax liabilities 0.4 0.3
Non-current interest-bearing liabilities 0.0  0.1
Other liabilities 0.0 0.0
Total non-current liabilities 0.4 0.4
     
CURRENT LIABILITIES    
Trade payables 0.5 0.4
Current interest-bearing liabilities 0.0 0.0
Tax liabilities 0.0 0.0
Other liabilities 1.0 0.8
Total current liabilities 1.6 1.3
     
Total liabilities 2.0 1.7
     
TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES 17.9 18.9

STATEMENT OF CHANGES IN EQUITY

Consolidated statement of changes in equity on 31 December 2018

EUR million Share capital Invested unrestricted equity fund Translation differences Fair value reserve Retained earnings Shareholders' equity
Shareholders' equity 1 Jan 2018 2.4 4.8 -0.1 0.9 9.3 17.2
Change in accounting policy       0.0 0.0 0.0
Restated total Shareholders' equity 1 Jan 2018 2.4 4.8 -0.1 0.9 9.4 17.2
Incentive scheme for senior management         0.0 0.0
Exercise of share options   0.1       0.1
Total comprehensive income for the period     0.0 0.6 -2.1 -1.5
Shareholders' equity 31 December 2018 2.4 4.9 -0.1 1.5 7.3 15.9

Consolidated statement of changes in equity on 31 December 2017

EUR million Share capital Invested unrestricted equity fund Translation differences Fair value reserve Retained earnings Shareholders' equity
Shareholders' equity 1 Jan 2017 2.4 4.3 -0.1 1.0 3.1 10.7
Incentive scheme for senior management         0.1 0.1
Exercise of share options   0.4       0.4
Total comprehensive income for the period     0.0 -0.1 6.1 6.0
Shareholders' equity 31 December 2017 2.4 4.8 -0.1 0.9 9.3 17.2

CASH FLOW STATEMENT

EUR million 1-12/2018 1-12/2017
CASH FLOW FROM OPERATING ACTIVITIES   
Profit for the period -2.1  6.1
Adjustments  2.0 -6.7
   
Change in working capital  0.1 -0.3
Interest paid and payments on other operating financial expenses -0.1  0.0
Interest received  0.1  0.1
Realised exchange rate gains and losses  0.0 -0.1
Income taxes paid -0.1 -0.1
Net cash flow from operating activities -0.1 -0.9
   
   
CASH FLOW FROM INVESTMENTS   
Investments in tangible and intangible assets  0.0 -0.2
Proceeds from disposal of tangible and intangible assets  0,0  
Proceeds from sale of share in joint venture (cash proportion)    1.7
Investments in funds and deposits -2.1 -0.9
Capital gain from investments in funds and deposits  2.1  0.5
Net cash flow from investments  0.0  1.2
   
CASH FLOW FROM FINANCING ACTIVITIES   
Rights issue 0.1 0.4
Proceeds from non-current loans   0.1
Repayment of loans 0.0 0.0
Net cash flow from financing activities 0.1 0.5
   
Increase (+)/decrease (-) in cash and cash equivalents 0.0 0.8
Cash and cash equivalents at the beginning of the period 1.3 0.6
Effect of exchange rates on cash and cash equivalents 0.0 0.0
Cash and cash equivalents at the end of the period 1.4 1.3

RELATED PARTY TRANSACTIONS

Biohit Oyj exited Joint Venture Biohit Healthcare (Hefei) Co. Ltd in first half of 2017 and since 1 June 2017 its result is no longer consolidated to Biohit Oyj.

During the review period Biohit Healthcare (Hefei) Co Ltd. acquired 33.2% of total number of shares in Biohit Oyj and 29.5% of the voting rights based on the shares. The transaction was closed on 8 June 2018. As a result of the transaction. Biohit Healthcare (Hefei) Co. Ltd reached significant influence in Biohit Oyj in accordance with IAS 28. Therefore all transactions between the parties that occurred during 8.6.2018-31.12.2018 are classified as related party transactions. Biohit Oyj sold EUR 3.0 million worth of goods and services to Biohit Healthcare (Hefei) Co. Ltd during the aforementioned period.

Biohit Oyj B-shares subscribed with stock options I 2013 during the 1-12/2018 reporting period

A total number of 65 198 new Biohit Oyj B-shares have been subscribed for with stock options I 2013 B during 2018. The share subscription price was 2.2766 per share. The entire subscription price of EUR 148 429.78 is credited to the reserve for invested non-restricted equity.

After the subscriptions the number of all Biohit Oyj's shares will rise to 14.952.041 shares and B-shares will rise to 11.976.541 shares.

The share subscription period with stock options I 2013 B began on 1 June 2015 and will end 31 May 2019. The terms and conditions of the option schemes with additional information are available on Biohit Oyj website at www.biohithealthcare.com.

In order to redeem the stock options the stock option holder has paid the subscription price in accordance with the stock option plan. The option holder also pays the income tax on the option income.


COLLATERAL, CONTINGENT LIABILITIES AND OTHER COMMITMENTS
 EUR million 31.12.2018 31.12.2017
   
Collateral granted on behalf of the parent company    
Guarantees 0.0 0.0
   
Collateral granted on behalf of the subsidiaries    
Guarantees   
 

Other liabilities
   
Leasing commitments    
Due for payment in less than one year 0.0 0.1
Due for payment in more than one year but less than five years 0.0 0.0
Due for payment beyond five years    
Total 0.0 0.1
   
Other rental commitments    
Due for payment in less than one year 0.2 0.2
Due for payment in more than one year but less than five years 0.1 0.3
Due for payment beyond five years    
Total 0.3 0.5
Other contingent liabilities 0.3 0.5
     
Collateral and contingent liabilities total 0.3 0.5
   

NEXT FINANCIAL REPORT

The half-year financial report for January - June 2019 (H1) will be published at 9:30 am local time (EET) on Wednesday 14 August 2019.


Helsinki, 20 February 2019

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