INTERIM REPORT OF BIOHIT GROUP Q3/2013

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Biohit Oyj October 24, 2013 at 9:30am local time (EET)

 

SUMMARY

January–September 2013

  • Net sales increased by 96 % compared with 2012
  • Net sales were EUR 2.7 million (EUR 1.4 million)
  • Operating profit was EUR -4.3 million (EUR -3.4 million)
  • Operating profit excluding non-recurring items was EUR -3.0 million (EUR -3.4 million)
  • Profit before taxes was EUR -4.3 million (EUR -2.8 million), which includes a non-recurring expense due to the stock option program (EUR 1.3 million) as well as other non-recurring items (EUR 0.1 million)
  • International operations accounted for 89 % of turnover (88 %)
  • Earnings per share were EUR -0.31 (EUR -0.20)
  • The equity ratio was 80.8 % (89.8 %)

July–September 2013

  • Net sales increased by 178 % compared with 2012
  • Net sales were EUR 1.3 million (EUR 0.5 million)
  • Operating profit was EUR -0.9 million (EUR -1.2 million)
  • Operating profit before taxes was EUR -0.9 million (EUR ‑0.8 million)
  • International operations accounted for 95 % of turnover (90 %)
  • Earnings per share were EUR -0.07 (EUR -0.06)
  • The equity ratio was 80.8 % (89.8 %)
  • Biohit launched a new celiac quick test
  • GastroPanel screening results from Kazakhstan 2012–2013

 

SEMI KORPELA, PRESIDENT AND CEO:

“During the third quarter, net sales increased by 178 % compared with the same period last year. The most important factors in the growth in net sales were exceptionally large GastroPanel deliveries to China. During the reporting period, we focused on working with our partners to ensure that sales got off the ground.

“In August, we launched a new celiac quick test, which uses fingertip blood. The new test is simple, fast and reliable. The quick test will not completely replace endoscopies, but it will bring clear cost benefits by reducing the number of unnecessary endoscopies. Doctors may use a positive test result for careful consideration for further study. Endoscopy and biopsies from the small bowel are needed to confirm the diagnosis. The quick test costs only a fraction of the price of a small bowel endoscopy.

Biohit Oyj has worked in collaboration with the Medical Center of the President’s Affairs Administration of the Republic of Kazakhstan to conduct a population-based screening study with the GastroPanel test. The screening was conducted in Astana in 2012 and 2013, and the final results became available during the reporting period. The scientific report on these screening results has been accepted for publication in Anticancer Research 2013, 33(10), a widely distributed international cancer journal.

During the reporting period the Chinese subsidiary’s operations were partly combined with the distributor functions and the remaining subsidiary’s operations were discontinued. There were no substantial expenses related to discontinuing the subsidiary operations.”

 

CONSOLIDATED KEY FIGURES

  7–9 / 2013 7–9 / 2012 1–9 /2013 1–9 /2012
Net sales (EUR million) 1.3 0.5 2.7 1.4
Operating profit/loss (EUR million) -0.9 -1.2 -4.3 -3.4
Profit/loss before taxes (EUR million) -0.9 -0.8 -4.3 -2.8
Profit/loss for the period (EUR million) -0.9 -0.8 -4.3 -2.8
Average number of personnel 47 39 43 39
Number of personnel at the end of the period 46 39 46 39
Equity ratio (%) 80.8 % 89.8 % 80.8 % 89.8 %
Earnings per share (EUR) -0.07 -0.06 -0.31 -0.20
Shareholders’ equity per share (EUR) 1.71 2.68 1.71 2.68
Average number of shares during the period 13,795,593 13,615,593 13,702,284 13,615,593
Number of shares at the end of the period 13,795,593 13,615,593 13,795,593 13,615,593

 

NET SALES AND RESULT

January–September

Net sales increased by 96 % compared with the same period in 2012, amounting to EUR 2.7 million (EUR 1.4 million 1-9/2012).

The operating loss was EUR -4.3 million (EUR -3.4 million 1–9/2012).

Development expenditure for the year 2013 totalled EUR 0.7 million (EUR 0.6 million 1–9/2012).

The company issued two stock option plans, recording a total of EUR 1.3 million in charges. Under Stock Option Plan I, the company offered 200,000 stock options to the CEO. Under Stock Option Plan II, the company offered a total of 420,000 stock options to Mikko Salaspuro and Martti Marvola. The costs related to Stock Option Plan II are fully recorded in the second quarter 2013 income statement. The options were issued to compensate the employees for earlier contracts by which immaterial property rights were transferred. The company is released from all other obligations.

The great potential for diagnostic products and acetaldehyde-binding products, and the related growth in the business, necessitates significant investment in distributor and partner networks, as well as support for partners (marketing authorisation, registration, marketing) and product development.

  

Consolidated net sales and operating income

 

EUR million 7–9/2013 7–9/2012 Change 1–9/2013 1–9/2012 Change 1–12/2012
Net sales 1.3 0.5 0.8 2.7 1.4 1.3 2.0
Change compared with the previous year (%) 178.0 %     95.7 %     -5.7 %
Operating income -0.9 -1.2 0.2 -4.3 -3.4 -1.0 -4.6
Change compared with the previous year (%) 18.2 %     -28.7 %     23.3 %
Operating income (% of net sales) -69 % -236 %   -163 % -248 %   -224 %

 

BALANCE SHEET

On September 30, 2013, the balance sheet total was EUR 29.3 million (EUR 40.9 million) and the equity ratio was 80.8 % (89.8 %).

 

FINANCING

Biohit Oyj’s financial position is good, enabling investment in the business, product development and commercialisation. At the end of the quarter, the company’s current financial assets were EUR 17.0 million including cash worth EUR 0.5 million. In addition, the company has a EUR 1.0 million investment due for payment in over one year, and EUR 6.8 million in receivables in an escrow account following a business transaction concluded at the end of 2011. The funds will be released on March 31, 2014, provided no claims concerning the transaction are made.

During the reporting period, working capital increased due to increase in production volumes.

 

RESEARCH AND DEVELOPMENT

Research and development has focused on the further development and improvement of existing innovations and products. The company also uses external experts and subcontractors in its research and development operations. The development expenditure has not been capitalised. During the year 2013 expenditure on research and development amounted to EUR 0.7 million (EUR 0.6 million 1-9/2012).

 

INVESTMENTS

The 2013 gross investments were EUR 2.2 million (EUR 0.2 million 1-9/2012). Investments have not impacted cash flow. Investments were paid by IPR investment in the joint venture, as well as by a direct share issue in the Italian subsidiary acquisition.

During the third quarter there were no significant investments.

 

PERSONNEL

During the reporting period, the average number of personnel employed by the Group was 47 (39 in the corresponding period in 2012), of whom 36 (30) were employed by the parent company and 11 (9) by subsidiaries. At the end of the reporting period, the number of personnel was 46 (39), of whom 37 (30) were employed by the parent company. The number of personnel has increased due to the acquisition of the Italian subsidiary and due to increase in research and development as well as production.

 

SHORT-TERM RISKS AND UNCERTAINTY FACTORS

The company’s key risk factors are related to changes in the business environment and the demand for the company’s products. These risk factors include financial changes in the selected market areas, the ability and willingness of various countries to improve their healthcare systems (development priorities, reimbursement practices, import restrictions, lengths of registration times) and requirements set by customers on the products. To minimise short-term risk factors, it is vital that new market areas be selected in good time, along with professional partners and marketing measures.

Developing the business and launching new products necessitate significant investments.

The company aims to make a profit with a very low risk of capital loss when it makes investments related to its liquid assets. The investment portfolio consists of deposits, money market investments and corporate loans. Sufficient distribution of investments between asset categories, investment instruments and counterparties is essential. The company uses at least two partners for its investments in liquid assets.

  

OUTLOOK FOR 2013

The new Securities Markets Act (SMA) entered into force at the beginning of 2013, removing the obligation to present an assessment of future prospects in interim reports and financial statement releases. The future prospects need to be presented only in the management report by virtue of the Accounting Act. Biohit will therefore no longer provide details of future prospects in its interim reports. The latest outlook summary was published in the Q2 interim report on August 8, 2013. In the future, such information will be provided in connection with annual financial statement releases and in the management report by virtue of the Accounting Act.

 

MAIN EVENTS IN THE REPORTING PERIOD

Joint Venture in China

During the reporting period, three GastroPanel biomarker tests (PG-I, PG-II, gastrin-17) received a favourable re-imbursement approval in Anhui province, China. Registrations needed for the Joint Venture operations are in progress.


Biohit has released a new celiac quick test for sale

Biohit has released a diagnostic quick test that enables celiac disease to be diagnosed from a fingertip blood sample. Celiac disease is a relatively common autoimmune disease in which rye, wheat and barley protein (gluten) cause inflammation and damage of intestinal mucosa, thereby interfering with the absorption of nutrients. The quick test developed by Biohit confirms the diagnosis from a fingertip blood sample within ten minutes. The celiac quick test broadens the spectrum of Biohit’s diagnostic quick tests. The new test is CE-IVD registered and is initially available in European countries.

Biohit’s celiac quick test analyses human tissue transglutaminase (TTG) for all antibodies (IgA, IgG and IgM) directly from a fingertip blood sample. There are several tests available on the market that measure only the IgA antibody, but Biohit’s test also identifies IgA-deficient celiac patients within ten minutes. It is known that IgA-deficient people are ten times more likely to develop celiac disease than those with normal levels of IgA. The test will bring clear benefits in healthcare costs by reducing the number of unnecessary endoscopies. A positive result from the celiac quick test can lead to further diagnosis. Endoscopy and biopsy from the small bowel are needed to confirm the diagnosis.

 

Clinical trial

GastroPanel screening results from Kazahkstan 2012–2013

Biohit Oyj has worked in collaboration with the Medical Center of the President’s Affairs Administration of the Republic of Kazakhstan to conduct a population-based screening study with the GastroPanel test. The study was conducted in Astana in 2012 and 2013, and the final results are now available. A hospital-derived cohort of over 800 subjects was tested using the GastroPanel assay, which is a simple blood test measuring the serum levels of four stomach-specific biomarkers. This test is designed for two purposes: 1) as a first-line diagnostic tool for all patients complaining of dyspeptic symptoms, and 2) for screening of the specific stomach conditions associated with an increased risk of developing gastric cancer. Gastric cancer remains among the leading causes of cancer mortality worldwide and Kazakhstan is one of the high-incidence countries.


Other on-going research projects

Biohit is continuing its Biofilter research project. Biofilter is a filter solution for smoking that efficiently absorbs acetaldehyde in cigarette smoke and thus prevents it from entering the smoker’s saliva and respiratory tract.

In addition, the company is continuing a research project to study whether acetaldehyde binding and the neutralizing Acetium lozenge can help smokers to quit. Based on the results of numerous animal studies it is known that cancer-inducing acetaldehyde is also highly addictive.

Biohit Oyj has received the preliminary results of a clinical trial conducted to determine the capacity of the company’s new BioAcetium product to treat Helicobacter pylori infections. Based on the results, Biohit will conduct further studies using longer treatment times. In these studies, BioAcetium will also be combined with an antibiotic that does not cause the development of antibiotic-resistant strains of the bacteria.


Acetaldehyde measurements

During the reporting period, new acetaldehyde measurements were carried out on Finnish sour whole milk (“viili”) products. Biohit measured the concentrations of carcinogenic acetaldehyde in viili products generally on sale in the Greater Helsinki Region, Finland. The sample consisted of 21 different brands selected randomly from grocery outlets. The analysis demonstrated that the concentrations of carcinogenic acetaldehyde in viili products varied between 0–12 µM. Eleven brands contained no concentrations of carcinogenic acetaldehyde. The highest concentration measured was 12 µM.

In previous studies on yogurts, the concentrations of carcinogenic acetaldehyde varied between 14–394 µM. In one yogurt brand, the concentration of carcinogenic acetaldehyde was under the threshold level (100 µM or possibly significantly less). In all other brands, the concentration was equal to or greater than 205 µM. Thus, the measured yogurts contained, on average, 20 times higher levels of carcinogens than viili products.


Changes to Biohit Oyj’s management

Jaana Mattila, M.Sc. (Econ.) (b. 1966) was appointed as Chief Financial Officer (CFO) and a member of the management team of Biohit Oyj as of August 26, 2013. Before working for Biohit, she has worked as Finance Director at Fazer Amica Oy and in finance managerial positions at Stora Enso Oyj and Baxter Oy.

 

EVENTS OCCURRING AFTER THE REPORTING PERIOD

Biohit Oyj’s Option Schemes I 2013 and II 2013 – Terms update and Management Team Option Arrangement

On October 15, 2013, Biohit Oyj’s Board of Directors decided to distribute a total of 60,000 option rights in class I 2013A of the option scheme I 2013 to the members of the company’s management team (excluding the CEO) as follows: Panu Hendolin: 12,000, Jaana Mattila: 12,000, Anu Mickels: 12,000, Lea Paloheimo: 12,000 and Kari Syrjänen: 12,000. For option rights in this class, the share subscription period commences on June 1, 2014 and ends on May 31, 2019.

In addition, the Board of Directors has decided to amend the conditions of both scheme I 2013 and scheme II 2013 so that EUR 0.17 from the subscription price is recorded in the share capital. Correspondingly, the subscription price shall be at least EUR 0.17.

 

SHARE TURNOVER AND PRICE DEVELOPMENT

Biohit Oyj’s shares are divided into series A and series B shares. There are 2,975,500 series A shares and 10,820,093 series B shares, totalling 13,795,593 shares. Series A shares confer 20 votes per share and series B shares 1 vote per share. 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. The total market capitalisation (assuming that the market capitalisation for series A and B shares is equal) at the end of the period was EUR 88.6 million (EUR 27.6 million on September 30, 2012).

Biohit Oyj’s Series B shares have been listed on NASDAQ OMX Helsinki in the Small cap/Healthcare group under the code BIOBV.

 

BIOBV/NASDAQ OMX Helsinki 1–9/2013 1–9/2012
High (EUR) 9.10 3.97
Low (EUR) 4.00 2.00
Average (EUR) 6.54 2.85
Latest (EUR) 6.42 2.03
Turnover (EUR) 51,081,867 8,981,178
Turnover volume 7,811,096 3,147,611

 

Shareholders

At the end of the reporting period on September 30, 2013, the company had 6,067 shareholders (4,569 on September 30, 2012). Private households held 77.31 % (71.91 %), companies 20.86 % (21.63 %) and non-profit institutions 0.01% (0.03 %) of the shares. Foreign ownership or nominee registrations accounted for 1.75% (3.90%) of all shares.

Further information on the shares, major shareholders and the management’s shareholdings is available on the company’s website at www.biohit.fi/investors.

 

ACCOUNTING PRINCIPLES

This interim report has been prepared in accordance with the IAS 34 standard.

Biohit has applied the same accounting principles in preparing this interim report as it did for its 2012 financial statements. The IFRS standards that came into effect in 2013 did not affect the accounting principles.

All figures in this interim report have been rounded up or down, so the sums of individual figures may deviate from the totals shown.

The figures in this interim report have not been audited.

  

CONSOLIDATED INCOME STATEMENT

EUR million 7-9/2013 7-9/2012 Change 1-9/2013 1-9/2012 Change 1-12/2012
Net sales 1.3 0.5 0.8 2.7 1.4 1.3 2.0
Materials and services -0.7 -0.3 -0.4 -1.3 -0.8 -0.6 -1.3
Gross margin 0.6 0.2 0.4 1.3 0.6 0.7 0.7
Sales and marketing -0.6 -0.6 -0.1 -1.6 -1.5 -0.2 -2.2
Administration -0.7 -0.6 -0.1 -3.4 -2.0 -1.4 -2.2
Product development -0.2 -0.2 0.0 -0.7 -0.6 -0.1 -1.0
Other operating income 0.0 0.0 0.0 0.0 0.0 0.0 0.1
Share of profit/loss in Joint Venture 0.0   0.0 0.0   0.0  
Operating profit/loss -0.9 -1.2 0.2 -4.3 -3.4 -1.0 -4.6
Financial income 0.0 0.3 -0.3 0.0 0.9 -0.8 1.2
Financial expenses 0.0 -0.2 0.2 -0.1 -0.4* 0.2 -0.3
Profit/loss before taxes -0.9 -0.8 0.0 -4.3 -2.8 -1.5 -3.7
Income taxes 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Income for the period -0.9 -0.8 0.0 -4.3 -2.8 -1.5 -3.7
Translation differences 0.0 0.0 0.0 0.0 0.0 0.0 0.0
Total comprehensive income for the period -0.9 -0.8 0.0 -4.3 -2.8 -1.5 -3.7

 

Earnings per share calculated from earnings attributable to the owners of the parent company 1–9/2013 1–9/2012 1–12/2012
Undiluted earnings per share (EUR) -0.31 -0.20 -0.27

 

CONSOLIDATED BALANCE SHEET  

EUR million September 30, 2013 September 30, 2012 December 30, 2012
ASSETS      
NON-CURRENT ASSETS      
Intangible assets 1.2 0.2 0.2
Share in Joint Venture 1,0    
Tangible assets 0.5 0.0 0.4
Other financial long term assets 7.8* 8.0* 7.8*
Deferred tax assets 0.0 0.0 0.0
Total non-current assets 10.5 8.2 8.5
       
CURRENT ASSETS      
Inventories 0.6 0.4 0.4
Trade and other receivables 1.2 1.1 0.6
Other financial short term assets 16.5 30.9 30.2
Cash and cash equivalents 0.5 0.3 0.2
Total current assets 18.8 32.7 31.5
       
TOTAL ASSETS 29.3 40.9 40.0
       
SHAREHOLDERS’ EQUITY AND LIABILITIES      
Shareholders’ equity attributable to the owners of the parent company      
Share capital 2.3 2.3 2.3
Invested unrestricted equity fund 1.1 3.4 3.2
Translation differences 0.0 0.0 0.0
Retained earnings 20.2 30.6 30.0
Total shareholders’ equity 23.7 36.3 35.5
       
CURRENT LIABILITIES      
Trade payables 0.4 0.4 0.4
Total interest-bearing liabilities 0.4 0.4 0.4
Tax liabilities 0.0 0.0 0.0
Other liabilities 3.9 3.8 3.8
Deferred gain 1,0    
Total current liabilities 5.6 4.6 4.5
       
TOTAL SHAREHOLDERS’ EQUITY AND LIABILITIES 29.3 40.9 40.0

* Includes EUR 6.8 million in receivables from a business transaction; the funds are placed in an escrow account. Funds will be released from the escrow account March 31, 2014 provided no claims concerning the transaction are made.

 

STATEMENT OF CHANGES IN SHAREHOLDERS’ EQUITY

Statement of changes in consolidated shareholders’ equity on September 30, 2013

EUR million Share capital Translation differences Invested unrestricted equity fund Retained earnings Shareholders’ equity
Shareholders’ equity 1 Jan 2013 2.3 0.0 3.2 30.0 35.5
Total comprehensive income for the period   0.0   -4.3 -4.3
Distribution of dividend       -6.8 -6.8
Capital repayment     -3.2   -3.2
Share issue to Euroclone     1.1   1.1
Exercise of share options       1.4 1.4
Shareholders’ equity September 30, 2013 2.3 0.0 1.1 20.2 23.7

 

Statement of changes in consolidated shareholders’ equity on September 30, 2012   

EUR million Share capital Translation differences Invested unrestricted equity fund Retained earnings Shareholders’ equity
Shareholders’ equity 1 Jan 2012 2.3 0.0 14.3 36.2 52.8
Total comprehensive income for the period   0.0   -2.8 -2.8
Distribution of dividend       -2.7 -2.7
Capital repayment     -10.9   -10.9
Shareholders’ equity September 30, 2012 2.3 0.0 3.4 30.6 36.3

 

CASH FLOW STATEMENT

EUR million 1–9/2013 1–9/2012 1–12/2012
CASH FLOW FROM OPERATING ACTIVITIES      
Profit for the period -4.3 -2.8 -3.7
Adjustments 1.5 -0.7 -0.8
       
CHANGE IN WORKING CAPITAL -0.8 -0.2 -0.2
Interest paid and payments on other operating financial expenses 0.0 -0.7 -0.8
Interest received 0.2 0.2 1.1
Realised exchange rate gains and losses 0.0 0.0 0.0
Income taxes paid 0.0 -4.5 -4.5
Net cash flow from operating activities -3.5 -8.4 -8.9
       
CASH FLOW FROM INVESTMENTS      
Investments in tangible and intangible assets -0.1 0.0 -0.3
Net investments in funds and deposits 13.8 -20.9 -20.2
Net cash flow from investments 13.7 -20.9 -20.5
       
CASH FLOW FROM FINANCING ACTIVITIES      
Dividend payout -6.8 -2.7 -2.7
Repayment of capital -3.2 -10.9 -10.9
Repayment of loans 0.0 -4.7 -4.7
Net cash flow from financing activities -10.0 -18.3 -18.3
       
Increase (+)/decrease (-) in cash and cash equivalents 0.2 -47.6 -47.7
Cash and cash equivalents at the beginning of the period 0.2 47.9 47.9
Effect of exchange rates on cash and cash equivalents 0.0 0.0 0.0
Cash and cash equivalents at the end of the period 0.5 0.3 0.2

 

PLEDGES, CONTINGENT LIABILITIES AND OTHER LIABILITIES

EUR million 1–9/2013 1–9/2012 1–12/2012
       
Collateral granted on behalf of the parent company      
Corporate mortgages 0.0 0.0 0.0
       
Collateral granted on behalf of subsidiaries      
Guarantees 0.0 0.0 0.0
       
Other liabilities      
Leasing commitments      
Due for payment in more than 1 year 0.1 0.0 0.0
Due for payment in more than 1 year but less than 5 years 0.1 0.0 0.0
Due for payment in more than 5 years 0.0 0.0 0.0
Total 0.2 0.0 0.1
       
Other rental commitments      
Due for payment in more than 1 year 0.2 0.2 0.2
Due for payment in more than 1 year but less than 5 years 0.3 0.4 0.3
Due for payment in more than 5 years 0.0 0.0 0.0
Total 0.5 0.6 0.4
Total other liabilities 0.0 0.0 0.0
       
Total collaterals and contingent liabilities 0.7 0.6 0.5

 

NEXT FINANCIAL REPORT

Biohit’s 2013 Annual Report will be published on Thursday February 27, 2014 at 9:30am local time.

 

Helsinki, October 24, 2013

Biohit Oyj
Board of Directors

 

Additional information:

CEO Semi Korpela, Biohit Oyj
Tel. +358 9 773 861
investor.relations@biohit.fi
www.biohithealthcare.com

 

Biohit in brief

Biohit Oyj is a globally operating Finnish biotechnology company established in 1988. Biohit’s mission is “Innovating for Health”. The purpose of the company is to take social responsibility and produce innovation, new technologies and analysis systems for use in medicine, research institutions and industry, helping to promote research and diagnostics and to improve people’s quality of life by preventing disease, human suffering and financial loss. We are committed to social responsibility and it is our duty to spread knowledge about the Group I human carcinogen, acetaldehyde, and innovate and develop the marketing and availability of our products and services. Biohit is headquartered in Helsinki, Finland and its subsidiaries are located in China, Italy and the United Kingdom. Since 1999, Biohit’s series B shares (BIOBV) have been listed in the NASDAQ OMX Helsinki Oy Small cap/Healthcare sector. www.biohithealthcare.com

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