2016-08-18 08:30:01 CEST
2016-08-18 08:30:01 CEST
REGULATED INFORMATION
Biohit Oyj - Half Year financial report
BIOHIT GROUP HALF YEAR FINANCIAL REPORT 2016
Biohit Oyj Half Year Financial Report August 18, 2016 at 9:30 am local time
(EEST)
SUMMARY
January–June 2016
-- Net sales grew by 8.4% compared to 1-6/2015
-- Net sales EUR 3.8 million (EUR 3.5 million)
-- Operating loss EUR -2.1 million (EUR -1.5 million)
-- The result for the reporting period was EUR -2.1 million (EUR -1.4 million)
-- Net sales from international operations 90.5% (88.2%) of total net sales
-- Equity ratio 85.4% (84.7%)
PRESIDENT & CEO SEMI KORPELA:
‘In the first half of the year 2016, our net sales grew by 8.4% compared to the
reference period Q1-Q2/2015. With regard to the costs, the most significant
change compared to the reference period is related to the costs incurred by the
new smoking intervention study and losses accrued from the Chinese joint
venture’s efforts made towards preparations to start manufacturing as well as
costs incurred in recruitments in ramp-up of the sales organization. Together
these caused an additional cost of EUR 0.7 million. The other cost structure of
the Group has not substantially increased from the comparison period. We
expanded our international distributor network, intensified cooperation with
our partners, updated our product range and commercialised new products as well
as communicated study results significant to Biohit’s future to the important
stakeholders of the company. We continued increasing the awareness of
decision-makers, doctors and broader public on carcinogenic acetaldehyde and
importance of the screenings. Our spearhead products are Acetium®, GastroPanel®
and diagnostic quick tests as well as diagnostic analysis systems and
laboratory services. Main market areas are China, Europe, Russia and Middle
East.
We expanded our distributor network and advanced product registrations as well
as reimbursement practices
We continued expanding our distributor network with new agreements and by
restructuring the existing agreements. During the first half of 2016, we signed
the following contracts for the distribution of Biohit’s diagnostic products:
OnSite Diagnostic Lab India Pvt Ltd will sell our diagnostic tests in India and
SPD Scientific Pte Ltd. in Thailand. Arad TajhizAzma Ltd. was appointed as
distributor of Biohit Total 25OH vitamin D test in Iran. Diagnostic tests in
the Philippines will be distributed by UC Biosciencies Inc. Pooyandegan
Pezeshki Pardis was appointed as distributor of GastroPanel® test in Iran and
Delta Biologicals S.r.l. in Southeastern Italy. Tianjin Jingsheng Biological
Technology Development Co. Ltd. will distribute the Biohit Calprotectin test in
China. We extended the exclusive distribution agreement with our partner Melon
OOO for the next contract period. After the reporting period, we signed a
contract with Beijing HuayiHuilang Medical Instrument Co., Ltd of the
distribution of Celiac Disease Quick Test in China.
During the reporting period, Ericon S.r.l. received exclusive right to sell
Acetium in Moldova, and Inversiones Naturalia S.A. in Panama. The L-cysteine
capsule binding acetaldehyde registered as a food supplement in Mexico with the
brand name Etium received an import permit for Mexico in May 2016. The first
sales lot was delivered to Mexico early this summer. During the first half of
the year 2016, registration of several diagnostic tests was completed in Costa
Rica. In general, the duration of the product registration process is different
in each market area. It is not possible to accurately predict the time needed
by the authorities to handle and complete the registrations in different
countries and for product sales to begin.
During the first half of 2016, a price approval decision on the three
GastroPanel® tests (pepsinogen l, pepsinogen II, gastrin-17) was issued in two
Chinese provinces. The price approval decision has already been issued in 14
provinces by now: Anhui, Gansu, Hebei, Henan, Hunan, Jilin, Sichuan, Tianjing,
Shandong, Jiangsu, Inner Mongolia, Liaoning, Shanxi and Shaanxi. Price approval
is the pre-requisite for reimbursement of GastroPanel® and start of the sales.
We bought a share of Norwegian Genetic Analysis AS company with a directed
share issue
Biohit Oyj and Genetic Analysis AS (www.genetic-analysis.com) 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
contract 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,
complementing Biohit’s products and services. In the future, Genetic Analysis
will also operate as a distributor to Biohit Oyj’s selected products and
services in Norway.
We started the confirmatory smoking intervention trial
Biohit Oyj started the confirmatory smoking intervention trial in cooperation
with research agency Kuulas Helsinki. The aim of the study is to confirm the
promising results obtained in the previous study with a similar design.
Provided that the difference between the treatment and placebo groups will
remain at least the same, the new study is designed to ensure adequate
statistical power to confirm that the Acetium lozenge is a breakthrough in the
development of smoking intervention methods.
The scientific report of the first smoking intervention study by Biohit was
published in a widespread international journal Anticancer Research. According
to the trial, the Acetium lozenge is a promising novel method to assist in
smoking cessation. Additionally, the lozenge has beneficial effects on oral
health and it binds carcinogenic acetaldehyde dissolved into the saliva from
cigarette smoke and formed endogenously from alcohol into a harmless compound.
Separate screening studies provided additional evidence on detection of gastric
cancer risk and vitamin-B12 deficiency
Additional scientific evidence was obtained regarding the association between
Helicobacter pylori and gastric cancer. A long-term follow up of the population
screened in 1994-1996 was completed, and the study report was accepted for
publication in Scandinavian Journal of Gastroenterology. The study confirms
previously reported results implicating that Helicobacter pylori infection
alone increases significantly the risk for gastric cancer. This risk increases
substantially further, when untreated infection has progressed to atrophic
gastritis.
More evidence on GastroPanel® test as a predictor of gastric cancer risk was
also reported recently. Low Pepsinogen I level in the GastroPanel® test
predicts the risk for stomach cancer even years in advance. This was
established in two separate recent studies among Asian and Caucasian
population, where the subjects were followed-up for several years after
GastroPanel® testing. Low serum levels of Pepsinogen I accompanied by increased
Gastrin-17, is a sign of atrophic gastritis of the corpus. This, in turn, is a
known risk factor, e.g. for gastric and oesophageal cancer. This longitudinal
predictive value of GastroPanel® test for gastric cancer has not been
previously confirmed in a Caucasian population.
According to a study conducted in Estonia and Finland, a majority of B12
vitamin deficient cases in elderly people in Estonia and less than 25% in
Finland remained undiagnosed. The study compared the prevalence of atrophic
gastritis and vitamin-B12 levels in elderly people in both countries. Early
diagnosis of atrophic gastritis and vitamin-B12 deficiency in elderly people is
important to prevent, e.g. the irreversible neurological complications as well
as memory loss and depression. Atrophic gastritis is caused by Helicobacter
pylori infection or autoimmune disease. Atrophic gastritis is related to an
increased risk for gastric and oesophageal cancers and it is the most important
cause of vitamin-B12 deficiency. In all cases when vitamin-B12 deficiency is
suspected, it is appropriate to make GastroPanel® test, which accurately
detects atrophic gastritis unlike the other commonly used helicobacter tests
(www.biohithealthcare.com/additional-information )
We offered our expertise at the disposal of food industry
After the reporting period, we started cooperation with Pyynikin Craft Brewery
and brought our biotechnological expertise at the disposal of the brewery
production process. As a result of this cooperation, Pyynikin Craft Brewery
launched a new beer brand called Pyynikin Vapaa (‘Pyynikki’s Free’), in the
production of which the consumers’ demands were taken into account. The product
is, among other properties, gluten-free and it has a very low acetaldehyde
level. The cooperation with the brewery was a new business area for Biohit and
it paves the way for developing the production of other food stuffs as well. We
want to be part of the development aimed to offering the customers alimentary
products made of pure raw materials.’
THE GROUP’S KEY FIGURES
1-6/2016 1-6/2015 1-12/2015
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Net sales (MEUR) 3.8 3.5 6.1
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Operating profit/loss (MEUR) -2.1 -1.5 -2.9
--------------------------------------------------------------------------------
Profit/loss before taxes (MEUR) -2.1 -1.3 -2.9
--------------------------------------------------------------------------------
Profit/loss for the period, -2.1 -1.4 -2.9
total (MEUR)
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Average number of personnel 55 53 52
--------------------------------------------------------------------------------
Number of personnel at the end of the period 58 58 49
--------------------------------------------------------------------------------
Equity ratio (%) 85.4% 84.7% 87.9%
--------------------------------------------------------------------------------
Earnings per share (EUR) -0.14 -0.10 -0.20
--------------------------------------------------------------------------------
Shareholders' equity per share (EUR) 0.74 0.82 0.72
--------------------------------------------------------------------------------
Average number of shares during the period 14,619,501 14,201,454 14,276,519
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Number of shares at the end of the period 14,698,533 14,315,593 14,348,533
REPORTING
Biohit's product portfolio consists of diagnostic tests, analysis systems,
products binding carcinogenic acetaldehyde into a harmless compound, 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-June
Net sales grew by 8.4% compared with 1-6/2015.
The operating loss was EUR -2.1 million (EUR -1.5 million 1-6/2015). The result
for the reporting period totaled EUR -2.1 million (EUR -1.4 million).
Consolidated net sales and result
1-6-/2016 1-6/2015 Change 1-12/2015
--------------------------------------------------------------------------------
Net sales MEUR 3.8 3.5 0.3 6.1
--------------------------------------------------------------------------------
Change compared with the previous year 8.4%
(%)
--------------------------------------------------------------------------------
Operating income MEUR -2.1 -1.5 -0.6 -2.9
--------------------------------------------------------------------------------
Change compared with the previous year -42.1%
(%)
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Operating income (% of net sales) -54% -41% -48%
BALANCE SHEET
On 30 June 2016, the balance sheet total was EUR 12.8 million (31 December 2015
EUR 11.7 million). At the end of the reporting period, our equity ratio stood
at 85.4% (31 December 2015 87.9%).
FINANCING
Biohit Oyj has a moderate financial position, which allows necessary investment
in building 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 totaled EUR 8.1 million
including EUR 2.5 million worth of Genetic Analysis AS shares (31 December 2015
EUR 7.2 million).
RESEARCH AND DEVELOPMENT
During the first half of the year, we focused on innovating new products and
preparing them for the market. We improved the technical features of the
products in order to make them as simple and user-friendly as possible for the
customers.
Biohit employs external experts and subcontractors in its R&D operations.
Development expenditure has not been capitalised. Research and development
expenditure during the 1-6/2016 reporting period amounted to EUR 1.1 million
(EUR 1.1 million).
CLINICAL RESEARCH
During 2016, almost twenty clinical trials are ongoing in Finland and abroad
with the Biohit’s diagnostic tests and Acetium products
(www.biohithealthcare.com/scientific).
Confirmatory study on the efficacy of Acetium lozenge in smoking intervention
In the study completed in 2015, the efficacy of slow-release L-cysteine in
Acetium lozenge was assessed as a novel aid in smoking cessation. In meticulous
analyses of the results, the efficacy of Acetium lozenge in smoking cessation
was almost at the same level as that of nicotine replacement therapy (NRT),
which is currently the most commonly used method for smoking intervention.
Unlike the medications used for intervention, Acetium lozenge has no side
effects or restrictions for use, and it does not cause nicotine addiction. The
product binds carcinogenic acetaldehyde dissolved into the saliva from
cigarette smoke and formed endogenously from alcohol into a harmless compound.
In addition to this, the Acetium lozenge has beneficial effects on oral health,
due to its xylitol.
Although there was a marked difference between Acetium and placebo groups, the
statistical power was not sufficient due to the small sample size. To confirm
the results, the study will be repeated with a notably larger sample size. In
the beginning of 2016, a new double-blind, randomised trial was designed with a
sample size of 1,800 smokers. The study is estimated to be adequately powered
provided that the difference between Acetium and placebo groups will remain at
least equal to that of the first study. The study design is similar as in the
previous study, except that the participants will be randomised also by gender,
to control for the potential bias due to the male smokers showing a higher
propensity for giving up smoking shown in the first study. The study will be
conducted entirely over internet without contact visits to the research units.
Research agency Kuulas Helsinki is responsible for study logistics and
recruiting the voluntary study subjects. The recruitment of volunteers started
in May 2016, immediately after the ethical committee approval. The duration of
the study is six months for each subject.
Effect of Acetium capsule on migraine and cluster headache as well as on
atrophic gastritis
Two randomised double-blind studies investigating the effect of Acetium capsule
as a new method to prevent migraine and cluster headaches are still ongoing.
Both are multicenter studies started in 2014 in six centers in Finland. The
migraine study is approaching to its conclusion. The cluster headache study has
progressed more slowly, as cluster headache is a rare disease and the
occurrence of the attacks is related to the annual season. Because blinding is
perfect in both studies, and unblinding will be made only at study completion,
not even preliminary results are available.
As to the long-term studies, the placebo-controlled double-blind study testing
efficacy of the Acetium capsule in the treatment and cure of atrophic gastritis
is ongoing in two leading gastroenterology clinics in Italy (Bologna and
Parma). Final results are expected after two years at the earliest, as the
study includes a prolonged follow-up period to confirm whether the treatment is
effective in the long-term. Atrophic gastritis caused by helicobacter infection
or autoimmune disease can be diagnosed with the unique GastroPanel®
helicobacter test. Other helicobacter tests, 13C-urea breath test, fecal
antigen test and antibody tests still in use, cannot detect atrophic gastritis
with associated cancer risks, and the first two give plenty of false-negative
results in cases when the early discovery of helicobacter infection with
associated risks would be vital
(www.biohithealthcare.com/additional-information).
Prevalence of vitamin-B12 deficiency and its causes among the ageing population
in Estonia and Finland
During the spring of 2016, an international study investigating the prevalence
of latent vitamin-B12 deficiency and its cause, atrophic gastritis, among
elderly people beyond 75 years of age was completed. The study was carried out
by using the Biohit GastroPanel® test and measuring vitamin-B12 concentration
in blood. The study report is currently in press in an international scientific
journal of geriatrics. The results show that latent vitamin-B12 deficiency
among the ageing population is even more common than expected. At the same
time, the results show that serious complications, caused by vitamin-B12
deficiency can be prevented with early and appropriate GastroPanel® and
vitamin-B12 testing and replacement therapy.
Accuracy of GastroPanel® test in population-based screening in St. Petersburg
Another completed study assessed the diagnostic accuracy of GastroPanel® test
in a population-based screening. The project was conducted as collaboration
between two clinics in St. Petersburg. The results were completed in spring
2016, and the report was published in an international cancer journal in July
2016. This is the first screening study using GastroPanel® test, where only the
GastroPanel® positive subjects were controlled by gastroscopy and biopsies. The
results were also corrected for the verification bias, which has not been the
case in the previous GastroPanel® studies. The results show that GastroPanel®
test is also highly suitable for population-based screening of asymptomatic
people.
Clinical validation study of the unified GastroPanel® test
Clinical validation study of the unified GastroPanel® test is ongoing at the
gastroenterology clinic, GastroCenter, Oulu University Hospital (OUH). The
study validates the unified GastroPanel® test in gastroscopy referral patients.
The study subjects represent the patients referred to OUH for gastroscopy from
the primary health care. The first patients were examined in January 2016.
Based on the study results, reliable cut-off values for different diagnostic
categories of GastroPanel® test can be determined.
Comparative study of colorectal cancer screening tests in Brazil
An international study comparing colorectal cancer screening tests has been
ongoing in one of the leading cancer centers in Brazil since 2014. The study
design is similar as in in the previous study in St. Petersburg, published in
2015, but the cohort is larger. In the previously published study, Biohit’s
new-generation ColonView FIT test proved to be superior to the conventional
guaiac test, which is non-specific to human blood. ColonView FIT test detects
both hemoglobin (Hb) and hemoglobin-haptoglobin (Hb/Hp) complex in the stool
sample, whereas the conventional FOB test only detects Hb. The new comparative
study is estimated to be completed by the end of 2016.
Celiac disease quick test in pediatric patients in Romania
A study assessing the accuracy of the Biohit Celiac Disease Quick Test in
pediatric patients with suspected celiac disease is ongoing in a children’s
hospital in Romania. The study has progressed more slowly than expected, in
part because the local guidelines for the diagnostic work-up of celiac disease
have changed during this time.
Additionally, Biohit is the supplier of Celiac Disease Quick Test kits for an
extensive multi-center celiac disease screening study in healthcare centers in
the Netherlands, examining young people. The study is conducted by the
Department of Pediatrics, Leiden University Medical Center.
Helicobacter pylori as a cause for dyspepsia and its diagnostics
Globally, there is a very great demand for a simple, quick and reliable test
for the diagnosis of Helicobacter infection (gastritis), which causes dyspepsia
and many diseases. In western countries the prevalence of dyspepsia caused by
different reasons is 20-40%. It is estimated that 20-80% of the world’s
population is affected by the usually asymptomatic Helicobacter infection. It
is estimated that in Finland, over half of the 70-year-olds, quarter of the
30-50-year-olds and 10 % of those born after 1990 have helicobacter.
Sixteen gastroenterology experts from twelve different countries in the
international Healthy Stomach Initiative organization’s working group propose
the blood sample based GastroPanel® biomarkers for the basic examination of an
asymptomatic as well as a dyspeptic patient in order to screen and diagnose
Helicobacter pylori infection, and for atrophic gastritis which is caused by
helicobacter or autoimmune disease ( Agréus L, Kuipers EJ, Kupcinskas L,
Malfertheiner P, Di Mario F, Leja M, Mahachai V, Yaron N, van Oijen M, Perez
Perez G, Rugge M, Ronkainen J, Salaspuro M, Sipponen P, Sugano K, Sung J.
Rationale in diagnosis and screening of atrophic gastritis with
stomach-specific plasma biomarkers, Scandinavian Journal of Gastroenterology
2012; 47: 136 – 147).
Among dyspeptic patients, GastroPanel® helps to identify those in need of
gastroscopy and biopsy examination due to an increased risk for gastric cancer
(Syrjänen K. Serologinen testi dyspepsia-potilaiden diagnostiikkaan ja
mahasyövän riskiryhmien seulontaan. Best Practice Gastroenterologia 2015;1:
2-7, www.biohithealthcare.com/scientific: A simple blood test reveals whether
the stomach is healthy or not).
Undiagnosed helicobacter gastritis due to the test methods or other reasons can
progress to gastric cancer or most often asymptomatic atrophic gastritis, which
can cause the risk for gastric cancer and vitamin B12 deficiency. Atrophic
gastritis with its associated risks may also develop due to gastric mucosal
autoimmune disease and it may occur simultaneously with other autoimmune
diseases, such as type 1 diabetes and thyroiditis. It is well known that still
many gastric and oesophageal cancer cases lead to examination and treatment
only after the patient has so called alarming symptoms and a poor prognosis.
Contrary to current practice, atrophic gastritis, the most important risk
factor for the increasingly common vitamin B12 deficiency, is most advantageous
to treat early enough together with vitamin B12 determination, as the
population ages. (www.biohithealthcare.com/additional-information,
www.biohit.fi/varaaverkossa).
GastroPanel® and Acetium
The GastroPanel® and Acetium® innovations are together a unique combination
that can help prevent gastric and oesophageal cancers. GastroPanel® detects
atrophic gastritis, which is related to an increased risk for gastric and
oesophageal cancer, while the conditions are still treatable. Atrophic
gastritis of the gastric corpus, which is usually irreversible, leads to a
permanently anacidic stomach. In an anacidic stomach, which is also caused by
long-term proton pump inhibitor (PPI) treatment, microbes from the mouth can
survive and produce acetaldehyde from alcohol and the sugar present in food. In
2009, the WHO published a new list of carcinogenic compounds classifying
acetaldehyde present in alcoholic beverages and formed from ethanol
endogenously in Group 1, i.e., in the same category with the well-known
carcinogens asbestos, tobacco smoke and benzene. Globally, acetaldehyde
exposure mediated by gastrointestinal tract microbes or tobacco smoke is
associated with several important cancer types, including upper aerodigestive
tract cancer, colon cancer and lung cancer. Biohit Oyj has developed Acetium®
products which can be used to reduce the exposure to acetaldehyde, which is
produced by microbes from ethanol or derived from food (www.acetium.com,
www.biohithealthcare.com/scientific/study-protocols).
Acetium® capsules bind the carcinogenic acetaldehyde in the stomach with
individuals suffering from an anacidic stomach due to the following reasons: 1)
atrophic gastritis, 2) PPI medication or 3) gastric surgery, as well as in
individuals with 4) a gene mutation affecting acetaldehyde metabolism or 5)
chronic helicobacter infection that produces acetaldehyde. Acetium capsules may
treat atrophic gastritis and prevent migraine and cluster headache (studies
ongoing).
Acetium® lozenges improve oral health and additionally bind carcinogenic
acetaldehyde dissolved into the saliva from cigarette smoke and formed
endogenously from alcohol into a harmless compound. It may also assist in the
cessation of smoking (additional study ongoing). Acetium lozenge removes 87% of
the immediate effects of acetaldehyde in saliva from alcoholic beverages
containing high levels of acetaldehyde and over 90% of acetaldehyde dissolved
in saliva during smoking.
In 2012, the European Commission's appointed group of experts gave a unanimous
recommendation stating that cosmetic products may contain at most 5 mg/l of
acetaldehyde while no acetaldehyde may be added to mouth wash. Many alcoholic
beverages and foodstuffs sold in Finland exceed by several-fold the maximum
permitted acetaldehyde levels for cosmetic products
(www.biohithealthcare.com/laboratory-services/determination-of-acetaldehyde).
INVESTMENTS
Gross investments during the 1-6/2016 reporting period totalled EUR 0.1 million
(EUR 0.1 million). Key investments in the period were related to equipment
purchases.
PERSONNEL
During the review period, the Biohit Group employed 55 (53) people on average,
45 (45) of whom were employed by the parent company and 10 (8) 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 the 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 predict the time needed
by the authorities to handle the registrations, to complete the process in
different 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 significant 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
the launch of major screening projects, but a number of political risks may
affect 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. Studies assessing the
efficacy of the Acetium product in new indications, such as in prevention of
migraine attacks, were continued also in 2016. These, strategically important
projects will require significant additional investments also during the latter
half of 2016.
In the beginning of 2016, our partner GrandPharma started the sales of Acetium
capsule in China using the brand name Shubang. The product received wide
attention, for example in public transportation, social media and in printed
media. Royalties to be obtained from the sales of Shubang during the first half
of the year are not expected to have a material impact on Biohit’s result.
Biohit Biotech (Hefei) Co Ltd is expected to start production in the end of
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 ramp-up of the sales
organization and the recruitment of personnel have been successful. Sales of
the GastroPanel® tests produced in Finland to the distributors has had a good
start and the product has been sold for commercial purposes to almost 90
different distributors and in most of the provinces in China. One of the
short-term key objectives of the joint venture is expanding the coverage of the
distributor network, and it is subject to considerable efforts. Wide
distributor network is a prerequisite for full exploitation of the commercial
potential of the product in Chinese market, especially after the screening
studies have been completed.
The company aims to grow profitable and it is strongly committed to taking
actions necessary for the future, especially in international marketing. Net
sales growth is expected in 2016. The company does not publish forecasts when
the result will turn to positive.
MAIN EVENTS IN THE REPORTING PERIOD
Biohit Oyj bought a share of Norwegian Genetic Analysis AS company with a
directed share issue
Biohit Oyj and Genetic Analysis AS (www.genetic-analysis.com) 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 the right to sell Genetic Analysis AS’s Dysbiosis
Test globally under the Biohit brand and exclusively in Finland and in China,
complementing the company’s products and services. 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 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 and OnSite Diagnostic Labs India Pvt Ltd. signed an agreement for the
distribution of Biohit’s diagnostic tests in India
Biohit Oyj and Onsite Diagnostic Labs India Pvt Ltd signed a distributor
agreement for the unique Biohit diagnostic portfolio in India. OnSite
Diagnostic Labs India Pvt Ltd will focus on the marketing of Biohit's tests and
analysis systems in India. Diagnostic tests covered by the distribution
agreement include e.g.: GastroPanel®, Active vitamin-B12 test, Celiac Quick
test, Calprotectin test, ColonView FIT test. According to the CEO of Onsite
Diagnostic Labs India Pvt Ltd, the company focuses on key disease areas
contributing to death rates in India and brings advanced technologies and cost
savings for early diagnosis of gastric cancer risk using GastroPanel® analysis
systems. (www.gastropanel.com/decision-makers/screening-model)
Biohit and Tianjin Jingsheng Biological Technology Development Co. Ltd. signed
an agreement for the distribution of Biohit’s Calprotectin test in China
Biohit Oyj and Tianjin Jingsheng Biological Technology Development Co. Ltd
signed a distributor agreement for the distribution of the Biohit Calprotectin
ELISA test in China. In China, there seems to be differences in prevalence of
Inflammatory Bowel Diseases (IBD), that is ulcerative colitis and Crohn’s
disease between rural and urban populations. The disease is increasing
particularly among young people. Fecal calprotectin has proven to be a useful
biomarker of IBD. Biohit Calprotectin test differentiates reliably IBD and IBS
and reduces significantly the need of colonoscopies.
Pooyandegan Pezeshki Pardis to distribute Biohit GastroPanel®-test in Iran
Biohit Oyj and Pooyandegan Pezeshki Pardis (3P) have signed a contract for the
distribution of the Biohit GastroPanel® test in Iran, where gastric cancer
resulting from helicobacter infection and atrophic gastritis, is a particularly
common disease (www.biohithealthcare.com/additional-information) Most of the
studies have confirmed that in Iran helicobacter is found in almost 90 % of the
population, and more than 50% of children become infected before the age of 15
(J Clin Pathol 2004;57:37-42). Symptomatic Helicobacter pylori infection,
atrophic gastritis and high acid secretion detected by the unique GastroPanel®
require confirmation by gastroscopy and biopsies, and appropriate treatment and
monitoring. The other helicobacter tests, 13C-urea breath test, stool antigen
test and antibody tests, which are still in use, do not detect atrophic
gastritis with associated cancer risks. Additionally, 13C-urea breath test as
well as stool antigen test may give plenty of false-negative results in cases
where early detection of Helicobacter pylori infection with associated risks
would be of vital importance (www.biohithealthcare.com/additional-information)
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, as soon as the ethical
approval from the regional ethical committee was obtained. At least 1,800
voluntary smokers will be invited to the study. The aim of the new trial is to
confirm the promising results obtained in the previous corresponding trial. If
the study is successful, this new study (adequately powered to confirm the
statistical significance between Acetium and placebo) can confirm the previous
results according to which the Acetium lozenge would represent a breakthrough
also in the development of smoking intervention methods. The lozenge has
favorable effects on oral health, and it binds carcinogenic acetaldehyde
dissolved into the saliva from cigarette smoke. The study is expected to be
completed by the end of 2016.
The scientific report of the Biohit’s first smoking intervention trial was
published
The scientific report of the first smoking intervention study by Biohit was
published in a widespread international journal: Anticancer Research. According
to the trial, the Acetium lozenge is a promising novel method to assist in
smoking cessation.
Atrophic gastritis and vitamin B12 deficiency remain frequently undetected in
the ageing population – early diagnosis is important to prevent complications
A majority of B12 vitamin deficient cases in Estonia but less than 25% in
Finland remained undiagnosed. This is evident in a study comparing prevalence
of atrophic gastritis diagnosed with GastroPanel® and vitamin-B12 deficiency in
elderly people in Finland and Estonia. Early diagnosis of atrophic gastritis
and vitamin B12 deficiency in elderly people is important to prevent, e..g. the
irreversible neurological complications. Atrophic gastritis is caused by
Helicobacter pylori infection or autoimmune disease, is related to the risk of
gastric cancer, and is an important cause of vitamin-B12 deficiency.
More scientific evidence on GastroPanel® test – the test predicts gastric
cancer risk even at 15-year follow-up
Low Pepsinogen I level diagnosed with GastroPanel® test predicts the risk for
stomach cancer even years in advance. The result is evident in two separate
recent studies among Asian and Caucasian population, where the subjects were
followed-up for several years after GastroPanel® testing. Low Pepsinogen I
level in the blood sample accompanied by high Gastrin-17, is a sign of atrophic
gastritis of the corpus. The latter is known to be a risk factor for gastric
cancer. The long-term predictive value of GastroPanel® test as a predictor of
this risk has not been previously confirmed.
Helicobacter pylori infection increases the risk for gastric cancer – Long-term
follow-up of the population- screening in Finland was completed
Additional confirmatory scientific evidence is obtained regarding the
association between Helicobacter pylori and gastric cancer. A long-term follow
up of the population screened in 1994-1996 in two cities in Finland has been
completed, and the report was accepted for publication in Scandinavian Journal
of Gastroenterology. The study confirms previously reported results implicating
that even Helicobacter pylori infection alone increases significantly the risk
for gastric cancer. This risk increases further, when untreated Helicobacter
infection has progressed to atrophic gastritis.
Decisions of the Annual General Meeting of Biohit Oyj and the constitutive
meeting of the Board of Directors
The Annual General Meeting (AGM) of Biohit Oyj held on Monday April 25, 2016
approved the financial statements of the parent company and the consolidated
financial statements, and discharged the members of the Board of Directors and
the President and CEO from liability for the financial year 2015.
Distribution of dividends
The AGM approved the Board of Directors proposal that no dividend shall be paid
for the financial period ended on December 31, 2015.
Members of the Board of Directors
The AGM decided that the number of members of the Board of Directors would be
six (6) and elected the following Board members until the end of the next AGM:
current members MD, PhD, Professor (h.c.) Osmo Suovaniemi, MD, PhD, Professor
Mikko Salaspuro, Commercial Counselor Eero Lehti, M. Sc. Eng. Seppo Luode,
Managing Director Franco Aiolfi and Master of Political Science Janina
Andersson.
Additionally, the AGM decided that the Chairman of the Board of Directors would
be paid a meeting fee of EUR 1,600 and the other Board members would be paid a
meeting fee of EUR 1,500.
Election and remuneration of the Auditor
The AGM elected authorised public accountants PricewaterhouseCoopers Oy as the
company’s auditor until the end of the next AGM. The auditor will be paid
remuneration against the auditor’s invoice.
Authorisation of the Board of Directors to decide on the issue of shares and to
issue special rights entitling the receipt of shares
The AGM decided to authorise the Board to decide on the issue of shares and to
issue special rights referred to in Chapter 10, section 1 of the Limited
Liability Companies Act entitling the receipt of shares with the following
terms and conditions:
The maximum number of new Series B shares to be issued pursuant to the special
rights is 3,000,000, which corresponds to approximately 26.4% of the company’s
all existing Series B shares.
The authorisation includes the Board of Directors’ entitlement to decide on
all terms and conditions regarding the issue of special rights. The issue of
shares and the issue of special rights entitling to the receipt of shares can
occur deviant from the subscription right of the shareholders (special issue).
The authorisation remains valid for two years from the resolution of the GM and
the authorisation replaces the former authorisations.
All decisions of the AGM were made unanimously.
Constitutive meeting of Biohit Oyj’s Board of Directors
Biohit Oyj’s Board of Directors elected in its meeting Mr Osmo Suovaniemi as
the Chairman of the Board of Directors.
Biohit Oyj’s Option Scheme I 2013 – International Sales Management Option
Arrangement
Biohit Oyj’s Board of Directors decided to distribute in total 10,000 pcs
option rights in class I 2013E of the option scheme I 2013 to the key members
of the company’s international sales management as follows: Ilari Patrakka
5,000 pcs, Qiongchao Zhang 5,000 pcs.
Biohit Oyj Stock Options I 2013 were decided to register in the Finnish
book-entry system
Biohit Oyj decided to convert all outstanding Biohit Oyj I 2013A–E stock
options into Biohit Oyj I 2013 stock options. Additionally, the Board of
Directors of Biohit Oyj decided to register the Stock Options I 2013 in the
Finnish book-entry system. Registration will not affect the terms of the Option
Scheme or share subscription periods. The terms and conditions of Biohit Oyj
Stock Option Plan I 2013 are available on the company’s website
www.biohithealthcare.com/investors.
MAJOR EVENTS AFTER THE CLOSE OF THE PERIOD
Biohit Oyj and Pyynikin Craft Brewery to start cooperation
Biohit Oyj started cooperation with Pyynikin Craft Brewery. Biohit brought its
biotechnological expertise at the disposal of the brewery production process.
As a result of this cooperation, Pyynikin Craft Brewery launched a new beer
brand called Pyynikin Vapaa (‘Pyynikki’s Free’), in the production of which the
consumers’ demands were responded to. The product is, among other properties, a
gluten-free product. The cooperation with the brewery is a new business area
for Biohit and it paves the way for developing acetaldehyde-free food stuffs
and their production
(www.biohithealthcare.com/laboratory-services/determination-of-acetaldehyde).
Beijing HuayiHuilang Medical Instrument Co., Ltd to distribute Biohit Celiac
Disease Quick Test in China
Biohit Oyj and Beijing HuayiHuilang Medical Instrument Co., Ltd. signed an
agreement for the distribution of the Biohit Celiac Disease Quick Test in
China. According to the General Director of Beijing HuayiHuilang Medical
Instrument Co., Ltd:n, in China, celiac disease has so far received
insufficient attention. Biohit’s sensitive and specific Celiac Disease Quick
Test helps detect celiac disease patients among those with dyspeptic symptoms.
Vitamin B12 deficiency remains undetected and untreated far too often
particularly among elderly citizens
A lively discussion has been ongoing in daily newspapers, weekly magazines and
Finnish Medical Journal (SLL) as well on vitamin B12. In this discussion,
perhaps the most surprising has been the proposal to make a treatment attempt
(intramuscular B12-vitamin, at 1-2 week interval, three times) instead of a
detailed diagnostic work-up. The modern medical treatment should always be
based on correct diagnosis. In addition to determining vitamin-B12, it is
justified to recommend the cost-effective and highly informative GastroPanel®
test also for testing asymptomatic people always, when there is a possibility
that the person belongs to a risk group for vitamin-B12 deficiency. The most
important reason of vitamin-B12 deficiency is atrophic gastritis related to
helicobacter infection or autoimmune disease, remaining undetected with the
helicobacter tests still in use.
(www.biohithealthcare.com/additional-information,
www.biohithealthcare.com/investors/annual-report 2000, page 23: image and text,
www.biohit.fi/varaaverkossa)
GastroPanel® test detects the risk factors of gastric cancer – a
population-based screening study in Russia was completed
A population-based screening study for gastric cancer risk was completed in
Russia. The study results confirm the previous study results showing that
GastroPanel® detects patients at increased risk for developing gastric cancer.
GastroPanel® test was used for screening of randomly selected asymptomatic
people in a country with high incidence of gastric cancer. The results have
been published in the August issue of an international cancer journal
Anticancer Research.
Simultaneous testing of GastroPanel® biomarkers is possible – preliminary study
results were completed
In accordance with the licensing agreement signed in 2013 between Biohit Oyj
and clinical diagnostic company Randox Laboratories Ltd., an initial study
investigating the simultaneous analysis of Biohit GastroPanel® biomarkers using
Randox Biochip Array Technology (BAT) was completed. According to the
preliminary study results, BAT simultaneously detects three GastroPanel®
biomarkers from a single patient sample. The different tests of GastoPanel®
analysed at the same time make the assay even more cost-effective and
user-friendly for diagnosis of helicobacter infection and dyspepsia as well as
for gastric and oesophageal cancer screening.
Changes to Biohit Oyj’s Management Team
M.Sc. (Tech.), Daniela Söderström (b. 1987) was appointed as Quality and
Regulatory Affairs Director and a member of the Management Team of Biohit Oyj
as of July 5, 2016. She joined Biohit Oyj in 2014. In her new position she
reports to CEO Semi Korpela.
ADMINISTRATION
Biohit's financial reporting and Annual General Meeting in 2017
Biohit will publish a time table for financial reporting and Annual General
Meeting 2017 later this year.
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 and Regulatory Affairs Director Daniela Söderström and
Chief Medical Director Kari Syrjänen.
SHARES AND SHAREHOLDERS
Biohit Oyj’s number of shares is 14,698,533 (14,315,593), of which 2,975,500
(2,975,500) are Series A shares and 11,723,033 (11,340,093) are Series B
shares. The Series B shares are quoted on NASDAQ Helsinki in the Small
cap/Healthcare group under the code BIOBV.
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 72.8 million
(30 June 2015 EUR 66.3 million). Shares’ trade value during the period amounted
to EUR 7.1 million.
BIOBV/NASDAQ OMX Helsinki 1-6/2016 1-6/2015 1-12/2015
------------------------------------------------------------
High (EUR) 6.15 7.14 7.14
------------------------------------------------------------
Low (EUR) 4.71 4.55 4.22
------------------------------------------------------------
Average (EUR) 5.48 5.48 5.45
------------------------------------------------------------
Latest (EUR) 4.95 4.63 5.61
------------------------------------------------------------
Turnover (EUR) 7,060,808 10,815,222 22,618,230
------------------------------------------------------------
Turnover volume 1,286,255 1,879,529 4,014,402
------------------------------------------------------------
Shareholders
At the end of the reporting period on 30 June 2016, the company had 6,505
shareholders (6,739 on 30 June 2015). Private households held 79.4% (78.0%),
companies 20.3% (20.2%) and public sector organisations 0.0% (0.0%). Foreign
ownership or nominee registrations accounted for 4.2% (1.7%) 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
Half year financial report 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 half year financial
report as for its financial statements 2015.
Biohit classifies Genetic Analysis AS shares as an asset available for sale
recognised at fair value. The value of the investment for the half year
financial report is determined based on the assets market value, which led to a
positive change in the value of 0.4 million euros (including the effect of
deferred tax) in Genetic Analysis AS shareholdings. The change in the value is
recorded in other comprehensive income.
The figures in the half year financial report have not been audited.
CONSOLIDATED INCOME STATEMENT
---------------------------------------------------------
MEUR 1-6/20 1-6/20 Change 1-12/2
16 15 015
--------------------------------------------------------------------------------
Net sales 3.8 3.5 0.3 6.1
--------------------------------------------------------------------------------
Materials and services -1.7 -1.5 -0.2 -2.9
--------------------------------------------------------------------------------
Gross margin 2.1 2.0 0.0 3.2
--------------------------------------------------------------------------------
Other operating income 0.1 0.0 0.0 0.8
--------------------------------------------------------------------------------
Sales and marketing -1.1 -1.2 0.1 -2.3
--------------------------------------------------------------------------------
Administration -1.5 -1.2 -0.3 -2.4
--------------------------------------------------------------------------------
Production and product development -1.1 -1.1 0.0 -2.0
--------------------------------------------------------------------------------
Share of profit/loss in Joint Venture -0.4 0.0 -0.4 -0.1
--------------------------------------------------------------------------------
Operating profit/loss -2.1 -1.5 -0.6 -2.9
--------------------------------------------------------------------------------
Financial income 0.1 0.1 -0.1 0.2
--------------------------------------------------------------------------------
Financial expenses -0.1 0.0 -0.1 -0.2
--------------------------------------------------------------------------------
Share of the profit (loss) of associates
consolidated with the equity method
--------------------------------------------------------------------------------
Profit/loss before taxes -2.1 -1.3 -0.8 -2.9
--------------------------------------------------------------------------------
Income taxes 0.0 0.0 0.0 0.0
--------------------------------------------------------------------------------
Income for the period, total -2.1 -1.4 -0.7 -2.9
--------------------------------------------------------------------------------
Other comprehensive income after taxes
--------------------------------------------------------------------------------
Other comprehensive income to be reclassified to
profit or loss in subsequent periods
--------------------------------------------------------------------------------
Available-for-sale financial assets 0.5 -0.1 0.7 -0.2
--------------------------------------------------------------------------------
Translation differences -0.1 0.0 -0.1 0.0
--------------------------------------------------------------------------------
Other comprehensive income to be reclassified to 0.4 -0.1 0.6 -0.2
profit or loss in subsequent periods
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Total comprehensive income for the period -1.7 -1.5 -0.2 -3.1
Earnings per share calculated from earnings attributable to equity holders of
the parent company
1-6/2016 1-6/2015 1-12/2015
-----------------------------------------------------------
Undiluted earnings per share -0.14 -0.10 -0.20
-----------------------------------------------------------
CONSOLIDATED BALANCE SHEET
----------------------------------------------------------
MEUR 30.6.2016 30.6.2015 31.12.2015
--------------------------------------------------------------------------------
ASSETS
--------------------------------------------------------------------------------
NON-CURRENT ASSETS
--------------------------------------------------------------------------------
Intangible assets 1.3 1.5 1.4
--------------------------------------------------------------------------------
Tangible assets 0.8 0.9 0.8
--------------------------------------------------------------------------------
Share in Joint Venture 0.2 0.6
--------------------------------------------------------------------------------
Other financial long-term assets 0.0 0.0 0.0
--------------------------------------------------------------------------------
Deferred tax assets 0.1 0.1 0.1
--------------------------------------------------------------------------------
Total non-current assets 2.3 2.5 2.9
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
CURRENT ASSETS
--------------------------------------------------------------------------------
Inventories 0.7 0.7 0.6
--------------------------------------------------------------------------------
Trade and other receivables 1.8 1.6 1.0
--------------------------------------------------------------------------------
Other financial short-term assets 7.6 8.3 6.5
--------------------------------------------------------------------------------
Cash and cash equivalents 0.5 0.7 0.7
--------------------------------------------------------------------------------
Total current assets 10.5 11.4 8.9
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
TOTAL ASSETS 12.8 13.9 11.7
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
SHAREHOLDERS' EQUITY AND LIABILITIES
--------------------------------------------------------------------------------
Shareholders' equity attributable to the
owners of the parent company
--------------------------------------------------------------------------------
Share capital 2.4 2.4 2.4
--------------------------------------------------------------------------------
Invested unrestricted equity fund 4.3 2.3 2.4
--------------------------------------------------------------------------------
Translation differences -0.1 0.0 0.0
--------------------------------------------------------------------------------
Retained earnings 4.3 7.1 5.6
--------------------------------------------------------------------------------
Total shareholders' equity 10.9 11.8 10.3
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
NON-CURRENT LIABILITIES
--------------------------------------------------------------------------------
Deferred tax liabilities 0.3 0.2 0.2
--------------------------------------------------------------------------------
Other liabilities 0.0 0.0 0.0
--------------------------------------------------------------------------------
Total non-current liabilities 0.3 0.2 0.2
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
CURRENT LIABILITIES
--------------------------------------------------------------------------------
Trade payables 0.7 0.8 0.3
--------------------------------------------------------------------------------
Total interest-bearing liabilities 0.1 0.1
--------------------------------------------------------------------------------
Tax liabilities 0.0 0.0 0.0
--------------------------------------------------------------------------------
Other liabilities 0.9 1.0 0.8
--------------------------------------------------------------------------------
Total current liabilities 1.6 1.9 1.2
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Total liabilities 1.9 2.1 1.4
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES 12.8 13.9 11.7
STATEMENT OF CHANGES IN EQUITY
Statement of changes in consolidated shareholders' equity on June 30th, 2016
--------------------------------------------------------------------------------
-
MEUR Share Invested Translati Fair Retained Shareh
capita unrestricted on value earnings olders
l equity fund differenc reserve '
es equity
--------------------------------------------------------------------------------
Shareholders' 2.4 2.4 0.0 0.0 5.5 10.3
equity 1 Jan
2016
--------------------------------------------------------------------------------
Direct share 2.0 2.0
issue
--------------------------------------------------------------------------------
Share based 0.3 0.3
payments
--------------------------------------------------------------------------------
Total -0.1 0.5 -2.1 -1.7
comprehensive
income for the
period
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Shareholders' 2.4 4.3 -0.1 0.6 3.7 10.9
equity 30 June
2016
Statement of changes in consolidated shareholders' equity on June 30th, 2015
--------------------------------------------------------------------------------
-
Share Invested Translatio Fair Retained Shareh
capital unrestricted n value earnings olders
(MEUR) equity fund difference reserve (MEUR) '
(MEUR) s (MEUR) equity
(MEUR)
--------------------------------------------------------------------------------
Shareholders' 2.4 1.9 0.0 0.2 8.3 12.7
equity
1 Jan 2015
--------------------------------------------------------------------------------
Share based 0.1 0.1
payments
--------------------------------------------------------------------------------
Exercise of 0.4 0.4
share options
--------------------------------------------------------------------------------
Total 0.0 -0.2 -1.3 -1.5
comprehensive
income for
the period
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Shareholders' 2.4 2.3 0.0 0.0 7.1 11.8
equity 30
June 2015
CASH FLOW STATEMENT
---------------------------------------------------------------
MEUR 1-6/20 1-6/20 1-12/201
16 15 5
--------------------------------------------------------------------------------
CASH FLOW FROM OPERATING ACTIVITIES
--------------------------------------------------------------------------------
Profit for the period -2.1 -1.4 -2.9
--------------------------------------------------------------------------------
Adjustments 0.9 0.1 0.0
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Change in working capital -0.3 -0.3 -0.2
--------------------------------------------------------------------------------
Interest paid and payments on other operating -0.1 0.0 -0.2
financial expenses
--------------------------------------------------------------------------------
Interest received 0.1 0.2 0.2
--------------------------------------------------------------------------------
Realised exchange rate gains and losses 0.0 0.0 0.0
--------------------------------------------------------------------------------
Income taxes paid 0.0 0.0 -0.1
--------------------------------------------------------------------------------
Net cash flow from operating activities -1.6 -1.4 -3.1
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
CASH FLOW FROM INVESTMENTS
--------------------------------------------------------------------------------
Investments in tangible and intangible assets -0.1 -0.2 -0.2
--------------------------------------------------------------------------------
Revenue from disposal of tangible and intangible 0.0 0.1
assets
--------------------------------------------------------------------------------
Capital gain from the sale of liquid handling business 0.0 0.0
--------------------------------------------------------------------------------
Net investments in funds and deposits 1.5 1.3 3.0
--------------------------------------------------------------------------------
Net cash flow from investments 1.5 1.2 2.9
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
CASH FLOW FROM FINANCING ACTIVITIES
--------------------------------------------------------------------------------
Rights issue 0.4 0.5
--------------------------------------------------------------------------------
Dividend payout 0.0 0.0
--------------------------------------------------------------------------------
Repayment of loans -0.1 -0.1 -0.1
--------------------------------------------------------------------------------
Net cash flow from financing activities -0.1 0.3 0.4
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Increase (+)/decrease (-) in cash and cash equivalents -0.2 0.1 0.1
--------------------------------------------------------------------------------
Cash and cash equivalents at the beginning of the 0.7 0.6 0.6
period
--------------------------------------------------------------------------------
Effect of exchange rates on cash and cash equivalents -0.1 0.0 0.0
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Cash and cash equivalents at the end of the period 0.5 0.7 0.7
RELATED PARTY TRANSACTIONS 1-6/2016
During the first half of 2016, there were no notable changes in related party
transactions.
Biohit Oyj B-shares subscribed with stock options I and II 2013 during the
1-6/2016 reporting period
During 2016 there were no subscriptions with stock options.
COLLATERAL, CONTINGENT LIABILITIES, AND OTHER COMMITMENTS
--------------------------------------------------------------------------------
-
June 30, June 30, Dec
2016 2015 31,
2015
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Collateral granted on behalf of the parent
company
--------------------------------------------------------------------------------
Corporate mortgages 0.0 0.0 0.0
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Collateral granted on behalf of the
subsidiaries
--------------------------------------------------------------------------------
Guarantees 0.0 0.0 0.0
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Other liabilities
--------------------------------------------------------------------------------
Leasing commitments
--------------------------------------------------------------------------------
Due for payment in less than one year 0.0 0.1 0.0
--------------------------------------------------------------------------------
Due for payment in more than one year but less 0.0 0.1 0.0
than five years
--------------------------------------------------------------------------------
Due for payment in more than five years 0.0 0.0 0.0
--------------------------------------------------------------------------------
Yhteensä 0.1 0.2 0.1
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Other rental commitments
--------------------------------------------------------------------------------
Due for payment in less than one year 0.2 0.2 0.2
--------------------------------------------------------------------------------
Due for payment in more than one year but less 0.6 0.7 0.6
than five years
--------------------------------------------------------------------------------
Due for payment in more than five years 0.0 0.0 0.0
--------------------------------------------------------------------------------
Total 0.8 0.9 0.9
--------------------------------------------------------------------------------
Other contingent liabilities 0.8 1.1 0.9
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Collateral and contingent liabilities total 0.8 1.1 0.9
NEXT FINANCIAL REPORT
Biohit will publish a time table for financial reporting and Annual General
Meeting 2017 later this year.
Helsinki, 18 August 2016
Biohit Oyj
Board of Directors
Additional information:
CEO Semi Korpela
tel. +358 9 773 861
investor.relations@biohit.fi
www.biohithealthcare.com
Biohit Oyj in brief
Biohit 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
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