2017-02-20 08:30:01 CET
2017-02-20 08:30:01 CET
REGULATED INFORMATION
Biohit Oyj - Financial Statement Release
BIOHIT GROUP FINANCIAL STATEMENT RELEASE 2016
Biohit Oyj Financial Statement Release, 20 February 2017 at 9:30 am local time
(EET)
SUMMARY
January–December 2016
-- Net sales grew by 35.4% compared to 1-12/2015
-- Net sales EUR 8.2 million (EUR 6.1 million)
-- Operating loss, EUR -3.4 million (EUR -2.9 million)
-- The result for the reporting period was EUR -3.3 million (EUR -2.9
million)
-- Net sales from international operations 92.2% (88.3%) of total net sales
-- Equity ratio
83.0
% (87.9%)
July-December 2016
-- Net sales grew by 72.8% compared to 7-12/2015
-- Net sales EUR 4.4 million (EUR 2.5 million)
-- Operating loss, EUR -1.3 million (EUR -1.4 million)
-- The result for the reporting period was EUR -1.2 million (EUR -1.6 million)
-- Net sales from international operations 93.7% (88.9%) of total net sales
-- Equity ratio 83.0% (87.9%)
PRESIDENT & CEO SEMI KORPELA:
‘In the second half of 2016 our net sales grew by 72.8% compared to the
comparison period 7-12/2015. During the entire year our net sales grew by 35.4%
compared to 1-12/2015. In terms of operational development, Biohit Oyj has
focused on supporting the business activities of our joint venture Biohit
HealthCare (Hefei) Co. Ltd, expanding the international distributor network and
supporting partners, for example in product registrations. Especially our
operations in China developed in a favorable manner in 2016 and our joint
venture exceeded EUR 5 million in net sales with GastroPanel® (EUR 0.2 million
in 2015) and made a positive operational result (EUR -1.1 million 2015).
Our most important products are GastroPanel®, Acetium and diagnostic quick
tests. Our main market areas are Asia and Europe. The smoking intervention
study, which started in 2016, burdened the financial year’s costs in 2016 but
other comparable non-IFRS costs were at a similar level than 2015. For 2017 the
costs are not expected to grow, as the cost burden associated with clinical
studies focused on the year 2016. In addition the net cash flow from operating
activities improved by EUR 0.6 million compared to 2015.’
We expanded our distributor network and advanced product registrations
We continued expanding our distributor network with new agreements and by
restructuring agreements. During 2016 we signed following distribution
agreements of Biohit`s diagnostic products: OnSite Diagnostic Lab India Pvt Ltd
sells our diagnostic tests in India and SPD Scientific Pte Ltd. in Thailand. In
the Philippines UC Biosciencies Inc. will distribute diagnostic tests.
Pooyandegan Pezeshki Pardis was appointed as the GastroPanel® distributor in
Iran and Delta Biologicals S.r.I in southeast Italy. Tianjin Jingsheng
Biological Technology Development Co. Ltd was appointed as distributor for
Biohit´s calprotectin-test in China. We renewed the agreement with our Russian
partner Melon OOO for the exclusive right to distribute our diagnostic products
to a further contract period. In addition, we made a celiac disease quick test
and GA-mapTM dysbiosis test distribution agreements with Beijing HuayiHuilang
Medical Instrument Co.,Ltd in China and Glomedics distributes Lactose
Intolerance Quick Tests in South Korea. In Sri Lanka Easemed Global Ltd was
appointed as distributor for Helicobacter Pylori Quick Test. Furthermore, an
agreement with exclusive right to distribute calprotectin-test in Iran was made
with Iranian Arad Tajhiz Azma. In Sweden diagnostic tests are distributed
through XboXLab AB.
During the reporting period Ericon S.r.l. in Moldova and Inversiones Naturalia
S.A in Panama got exclusive rights to sell Acetium. The acetaldehyde binding
L-cysteine capsule, which was registered in Mexico as a food supplement and
under a product name Etium, was granted an import license in Mexico in May
2016. The first batch was delivered to Mexico in early summer. During the first
half of 2016 several diagnostic test registrations were concluded in Costa
Rica. In the end of 2016 Indian authorities granted import license for Biohit´s
several diagnostic tests. Additionally, during the second half of 2016
registrations in Thailand for several diagnostic tests, a re-registration of
GastroPanel® and H. Pylori quick test in Kazakhstan and registration of
ColonView, UFT300 and Quick test reader in Israel were concluded.
During 2016 a price approval decision on the three GastroPanel® tests
(pepsinogen l, pepsinogen II, gastrin-17) was issued in four Chinese provinces.
The price approval decision has already been issued in 20 provinces. Price
approval is a pre-requisite for reimbursability of GastroPanel® and start of
sales.
In general, the duration of the product registration process is different in
each market area. For this reason, it is not possible to accurately assess the
time it takes for the authorities to handle registrations in different
countries and for product sales to begin.
We bought a share of Norwegian Genetic Analysis AS with a directed share issue
Biohit Oyj and Genetic Analysis AS signed a share exchange agreement through
which Biohit Oyj acquired ownership of 18% of shares in the company. In
addition to this the companies signed a distribution agreement giving Biohit
Oyj a right to sell Genetic Analysis AS’s Dysbiosis Test under the Biohit brand
and exclusively in Finland and in China. In the future, Genetic Analysis will
also operate as a distributor to Biohit Oyj’s products and services in Norway.
Biohit Oyj’s Chinese joint venture starts production
Biohit Oyj’s Chinese joint venture Biohit HealthCare (Hefei) Co. Ltd production
facility has passed official test requirements and has been granted a license
enabling production and sales of products. Biohit HealthCare (Hefei) Co. Ltd
manufactures GastroPanel®-products developed by Biohit Oyj for the Chinese
market.
Screening studies provided additional information about the diagnosis of
gastric cancer risks and the frequency of vitamin B12 deficiency
More research evidence was obtained on the association of Helicobacter Pylori
with gastric cancer. The long-term follow-up of the subjects who participated
in a population-based screening during 1994-1996 was completed and the report
was published in Scandinavian Journal of Gastroenterology. The study confirms
the previous observations, according to which helicobacter infection alone
increases significantly the risk of gastric cancer. This risk increases
substantially when an untreated helicobacter infection has progressed to
atrophic gastritis.
Furthermore, we obtained additional evidence that GastroPanel® test predicts
the risk of stomach cancer. In GastroPanel® test, a low Pepsinogen I level
predicts stomach cancer risk even ten years in advance. These results were
obtained in two separate studies among Asian and Caucasian population, where
the subjects were followed-up for several years after GastroPanel® testing. The
long-term predictive value of GastroPanel® test as a predictor of this risk has
not been previously confirmed in a Caucasian population.
According to a study conducted in Estonia and Finland, in the majority of cases
in Estonia but less than 25% in Finland, vitamin B12 deficiency remains
undiagnosed among elderly people. In that study, the frequency of atrophic
gastritis and levels of vitamin B12 were compared among elderly people in both
countries.
Cancer screening pilots continued in China and Russia
We continued our efforts towards advanced medical practices, especially in
cancer screenings. The two pilot screening trials for gastric cancer risk
started in China in 2015 continued, using Biohit Oyj`s GastroPanel® test. The
first of these is a project of the National Clinical Research Center for
Digestive Diseases (Changhai Hospital), funded by the Ministry of Science and
Technology of China. The Ministry is the coordinator of this multi-center study
screening the risks of early gastric cancer. In the study, at least 20,000
persons will be screened in some 50 hospitals. The screenings were expected to
be concluded by the end of 2016.
The second study is being conducted in Chinese healthcare centers by the China
Health Promotion Foundation. The foundation is a public organisation,
administered by the Chinese Ministry of Health. Around half a million
40-80-year-old asymptomatic subjects will be screened in this trial. The sample
collection has started in the summer of 2015 and continued over the whole year
2016. Due to the fact, that both organisational sides of the study are public
organisations, and independent of Biohit Oyj and its joint venture, there is no
specific information available about the exact time of completion.
In 2015, Russian Federation started a pilot project for colorectal cancer
screening, targeted to 48-75-year old asymptomatic persons. In the pilot
project, around 20,000 persons will be screened, and the results are expected
to be available during 2017. Based on these results, the final selection of the
screening test to be used in the national screening program will be made, and
one of the options is Biohit Oyj`s ColonViewFIT test. The national screening is
organised and sponsored by the Russian Federal Government and it will be
conducted by local medical centers.
We brought our expertise for food industry
In 2016 we started a 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), responding to the consumers’
demands. The product is, among other properties, a gluten-free product and it
has a very low acetaldehyde level. The cooperation with the brewery is 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
7-12/2016 7-12/2015 1-12/2016 1-12/2015
--------------------------------------------------------------------------------
Net sales (MEUR) 4.4 2.5 8.2 6.1
--------------------------------------------------------------------------------
Operating profit/loss (MEUR) -1.3 -1.4 -3.4 -2.9
--------------------------------------------------------------------------------
Profit/loss before taxes (MEUR) -1.2 -1.6 -3.3 -2.9
--------------------------------------------------------------------------------
Profit/loss for the period. -1.2 -1.6 -3.3 -2.9
total (MEUR)
--------------------------------------------------------------------------------
Average number of personnel 52 51 53 52
--------------------------------------------------------------------------------
Number of personnel at the end 49 49 49 49
of the period
--------------------------------------------------------------------------------
Equity ratio (%) 83.0% 87.9% 83.0% 87.9%
--------------------------------------------------------------------------------
Earnings per share (EUR) -0.08 -0.11 -0.22 -0.20
--------------------------------------------------------------------------------
Shareholders' equity per share 0.73 0.72 0.73 0.72
(EUR)
--------------------------------------------------------------------------------
Average number of shares during 14 698 533 14 347 512 14 685 071 14 276 519
the period
--------------------------------------------------------------------------------
Number of shares at the end of 14 698 533 14 348 533 14 698 533 14 348 533
the period
--------------------------------------------------------------------------------
REPORTING
Biohit's product portfolio consists of diagnostic tests, analysis systems,
products binding carcinogenic acetaldehyde into a harmless compound, monoclonal
antibodies and service laboratory operations. The entire product and service
portfolio is reported under a single segment.
NET SALES AND RESULT
January-December
Net sales grew by 35.4% compared with 1-12/2015.
The operating loss was EUR -3.4 million (EUR -2.9 million 1-12/2015). The
result during the reporting period totalled EUR -3.3 million (EUR -2.9
million).
Consolidated net sales and operating profit
7-12/20 7-12/20 Change 1-12/20 1-12/20 Change
16 15 16 15
--------------------------------------------------------------------------------
Net sales MEUR 4.4 2.5 1.8 8.2 6.1 2.1
--------------------------------------------------------------------------------
Change compared with the 72.8% 35.4%
previous year (%)
--------------------------------------------------------------------------------
Operating income MEUR -1.3 -1.4 0.2 -3.4 -2.9 -0.5
--------------------------------------------------------------------------------
Change compared with the 10.8% -15.7%
previous year (%)
--------------------------------------------------------------------------------
Operating income -29% -57% -41% -48%
(% of net sales)
--------------------------------------------------------------------------------
BALANCE SHEET
On 31 December 2016, the balance sheet total was EUR 13.0 million (EUR 11.7
million). 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 2016, our equity ratio was 83.0% (87.9%).
FINANCING AND OPERATIONAL CONTINUITY
Biohit Oyj has a moderate financial position, which allows for the necessary
actions towards creating an international distributor network as well as the
development and commercialisation of new products. Liquidity is at a good
level. At the end of the reporting period, the company's financial assets
totaled EUR 7.7 million (EUR 7.2 million) containing EUR 3.2 million worth of
Genetic Analysis AS shares.
Despite loss making financial periods the company has managed to keep its
working capital on a good level and the management believes the working capital
will cover the operations for the next 12 months and the company is not
dependent on external financing to be able to guarantee the continuity of its
operations. Furthermore, as announced on 2 January 2017, the company expects to
receive EUR 1.8 million cash during the first half of the year from the
ownership arrangement of its joint venture, which is expected to strengthen
company’s working capital structure. The transaction requires approval from the
authorities. 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
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 1-12/2016 reporting period amounted to
EUR 2.0 million (EUR 2.0 million), of which the second half-year accounted for
EUR 0.8 million (EUR 1.0 million).
The main focus was in the development of the GastroPanel® quick test. The quick
test is particularly suitable for the test assortment at doctor’s offices and
small laboratories, and it is designed to operate with an automatic reader.
During 2016, a dysbiosis test was launched on the market measuring the gut
microbiota. A bone density measurement (by a newly designed equipment) was
added to the test portfolio of our laboratory services.
CLINICAL RESEARCH
Ongoing clinical trials continued and new trials were started
To confirm the promising results of the smoking intervention study, which was
concluded in November, 2015, a new, more comprehensive study with Acetium
lozenge was designed. The study setting is similar as in the previous study, in
which Acetium lozenge was found to be more effective than placebo in assisting
the cessation of smoking. This needs to be confirmed in an adequately powered
study. The new study with larger series of patients started in spring 2016 and
continues until the first half of 2017. L-cysteine slowly released from Acetium
lozenge binds the human carcinogen acetaldehyde in the saliva to form a
harmless compound, and in addition, improves oral health.
An international study comparing colorectal cancer screening tests still
continues in Barretos, Brazil. It has a similar design as the study completed
in 2015 but the cohort of screened patients is larger. This study is close to
completion and compares the sensitivity and specificity of Biohit Oyj’s
ColonViewFIT test and a traditional guaiac-based method as a screening test for
colorectal cancer. Based on the interim results, an abstract was submitted for
the 2017 congress of DDW (Digestive Disease Week) in the USA.
During 2016, the two randomised double-blind trials on patients who suffer from
migraine and cluster headaches still continued. Due to the slow recruitment of
the patients, the progress of these two studies is delayed. There are no
interim results available.
Year 2016 was also the starting point for a long-term treatment trial in two
clinics in Italy, where the efficacy of Acetium capsule in the treatment of
atrophic gastritis or in intervention of disease progression is tested in a
randomised placebo-controlled trial. This study setting necessitates a
sufficient number of patients who fulfill the selection criteria and an
adequate follow-up period after therapy. Due to these reasons, the total
duration of the project will be at least three years.
The results of the senior citizens study, which was concluded at the end of
2015, were published during 2016 in the Journal of Aging Research and Clinical
Practice. In this study, more than 200 residents of assisted housing facilities
in Finland (Tampere) and Estonia (Tartu), with an average age of over 80 years,
were tested with GastroPanel®- and vitamin B12 measurement. The aim was to
compare the prevalence of atrophic gastritis, helicobacter-infection and B12
vitamin deficiency. The study disclosed significant differences in the general
health of these elderly people between the two countries. This applies
particularly to the prevalence, detection rate and management practices of
helicobacter infection and vitamin B12 deficiency. Atrophic gastritis detected
by GastroPanel® examination is a common cause of vitamin B12 malabsorption, an
early diagnosis of which is emphasised also in this study.
Novel results on the use of GastroPanel® test and a meta-analysis
In 2016, Biohit’s Department of Clinical Research made a systematic review of
the entire literature published on the use of GastroPanel® test in diagnosis of
atrophic gastritis worldwide. All studies fulfilling the inclusion criteria
were subjected to a formal meta-analysis. Meta-analysis is a statistical
technique, which is suitable for calculating the pooled sensitivity and
specificity of GastroPanel® test in diagnosis of atrophic gastritis, based on
all published studies. Altogether, 27 studies fulfilled the inclusion criteria,
comprising nearly 9000 patients tested with GastroPanel® in different countries
and continents. Despite substantial variation between individual studies, the
pooled results of this meta-analysis are encouraging and clearly substantiate
the positive experiences of this test, reported in Biohit´s own studies and in
those conducted by its partners. Especially important is the high specificity
of GastroPanel® test in detecting atrophic gastritis signifying in practical
terms that in cases with a completely normal test result a probability of
atrophic gastritis or helicobacter-infection in the stomach is negligible.
In addition to this meta-analysis, also two other studies with significant
results conducted by Biohit or its partners were reported in Anticancer
Research-journal during 2016. One of these is a screening study with
GastroPanel® conducted in St. Petersburg with asymptomatic patients and the
other one is a case-control study with 10-year longitudinal setting, in which
the value of GastroPanel® as a predictor of a long-term risk of gastric cancer
was estimated. The suitability of GastroPanel® as a screening tool of
asymptomatic population was excellent and the test was sensitive and specific
to detect a. o. atrophic gastritis
(www.biohithealthcare.com/additional-information ). In the case-control study,
the below-threshold levels of GastroPanel® markers (PGI and PGII) were an
independent predictor for an increased risk of gastric cancer even during a
follow-up of 10 years. In the multi-variate model, the strongest predictor was
a low PGI/PGII-ratio, which is an indicator for mucosal atrophy in the
GastroPanel® marker profile.
The acetaldehyde-related studies produced new significant findings
During 2016, a new clinical acetaldehyde study in Uppsala University Hospital
was concluded. The study compared the effect of Acetium capsule and placebo on
the acetaldehyde levels in the gastric juice after alcohol intake in volunteers
who had an atrophic gastritis (acid-free stomach) confirmed by GastroPanel®
test and biopsy. Like in the previous studies, Acetium reduced the acetaldehyde
level in the gastric juice highly significantly (68%) as compared to placebo.
Furthermore, the study is the first to confirm that the slow-release L-cysteine
remains in the stomach for several hours and binds acetaldehyde into a harmless
MTCA-compound. These results were published in the November 2016 issue of
Scandinavian Journal of Gastroenterology.
Acetium has been in use by Japanese cancer researcher for quite a long time by
now. In Akita University the research group of Professor Katsunori Iijima (Head
of Gastroenterology Department) has conducted further studies assessing the
impact of Acetium on the internal acetaldehyde levels in the oesophageal and
gastric mucosa and its possible impact on preventing the recurrence of cancer
among the high-risk patients. GastroPanel® examination developed by Biohit Oyj
is a significant tool in assessing the cancer risk of these patients.
Awareness of acetaldehyde was increased
During 2016 the awareness of the harmfulness of acetaldehyde was increased in
several occasions. In conjunction with the Annual Medical Assembly professor
Mikko Salaspuro held a presentation about acetaldehyde as the most common
carcinogen in the world. The presentation provoked a lively public discussion.
Professor Salaspuro held a presentation about the same topic also in 8th Annual
Charles Lieber Satellite Symposium in New Orleans on 25 June 2016. The
presentation was called ‘Acetaldehyde a neglected human carcinogen’ and its
summary is published in an international serie ‘Experimental and Molecular
Pathology 102: 2017’.
In the light of the current knowledge, the packages of alcoholic beverages
should contain a statement on its possible content of acetaldehyde, which is
classified by the WHO as a human carcinogen. Given that there is no scientific
evidence to indicate that acetaldehyde and ethanol in the foodstuffs are less
carcinogenic than acetaldehyde in alcoholic beverages, the same requirements
should also apply to these products. Several alcoholic beverages and foodstuffs
have an acetaldehyde content in excess of 5mg/L, which is the recommended upper
limit for the acetaldehyde content in cosmetic products. Additionally, a
scientific committee set by the EU has proposed in 2012 that mouthwashes should
not contain acetaldehyde at all.
INVESTMENTS
Gross investments during the 1-12/2016 reporting period totalled EUR 0.1
million (EUR 0.2 million), of which the second half year accounted for EUR 0.0
million (EUR 0.0 million). Key investments in the period were related to
production automation-related equipment.
PERSONNEL
During the review period, the Biohit Group employed 53 (52 in 2015) people on
average. 44 (44) of whom were employed by the parent company and 9 (8) by the
subsidiaries. At the end of the year 2016, the Group employed 49 (49)
personnel, of whom 40 (40) were employed by the parent company and 9 (9) by the
subsidiaries.
SHORT-TERM RISKS AND UNCERTAINTY FACTORS
Biohit’s key risks are related to the investments required for business growth
and adequacy of economic resources these require in the medium term. 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 in the next 12-month-period.
Other risks are involved in areas such as the success of clinical trials, the
selection and development of new market areas and distribution channels,
personnel recruitment, registration processes, product pricing, and political
decision-making affecting the progress of screening programs. Significant
short-term risks are associated with the successful selection of new market
areas, the timing of expansion into selected markets and product success in
these markets. The recent increase in uncertainty factors associated with
international politics may have an unfavorable impact on the company's
business.
The duration of the product registration process is different in each market
area. For this reason, it is not possible to accurately assess the time taken
for the authorities to handle registrations in these areas and for product
sales to begin.
When investing liquid assets, the objective is to gain a return on investment
with a minimum risk of equity loss. The investment portfolio consists of
deposits, money market investments and corporate loans. A fundamental aspect in
portfolio management is sufficient diversification across different asset
classes, investment instruments and counterparties. Biohit conducts its
investment activities with at least two partners.
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 project 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 2017
Together with its distributors and license partners Biohit has several product
registrations ongoing in a number of different markets, which is affecting net
sales development. A number of such registrations are expected to be completed
in 2017. In addition, negotiations are in progress with new partners, including
on the launch of major screening projects, but a number of political risks are
affecting the progress of such projects.
China’s operations are in Biohit’s focus in 2017. In addition to the ongoing
screening studies Biohit’s joint venture Biohit HealthCare (Hefei) Co. Ltd has
succeeded in building a wide distributor network and customer base as well as
in commercialising GastroPanel® widely, making use of the previous work on
gaining price approval decisions in Chinese provinces. Development of sales has
been good and increasing, especially in the second half of the year. The joint
venture is well positioned to continue this work also in 2017. Biohit expects
to complete the reduction of the joint venture share capital during the first
quarter of 2017. As a result of the transaction Biohit Oyj estimates its
non-comparable operating result to turn clearly positive for 2017. Reduction of
the entire share capital of the joint venture is a part of our future
GastroPanel® strategy in China. Establishing a production plant, receiving the
needed licenses and commercialisation of the new product required sharing the
risk in the means of a joint venture but for a company, which is completely
Chinese-owned, is easier to get an access to national health care programs and
growth funding than for a company, which is partly foreign-owned.
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. Late 2016 Biohit
announced GastroPanel® quick test. GastroPanel® quick test differs from the
current version by being able to give the result already during a single
clinical appointment. GastroPanel® quick test is available in Europe after the
performance and clinical tests required by the CE certification process are
completed.
We also facilitated the access to our health tests. R-kioski convenience stores
are selling and marketing gift cards for Biohit Oyj’s health checks for
consumers.
We aim to grow profitable and are strongly committed to taking necessary
actions in order to build a profitable future for the company. Net sales growth
is expected in 2017. The company does not assess when the comparable result
will turn to positive.
BOARD’S PROPOSAL FOR DISTRIBUTIONS OF PROFIT
The parent company's distributable funds (unrestricted equity) on 31 December
2016 are
EUR 5,479,775.77, of which the period net loss is EUR 2,580,940.29. The Board
of Directors proposes to the Annual General Meeting that no dividend be paid
for the financial year.
MAIN EVENTS IN THE SECOND HALF OF THE YEAR (H2)
Beijing HuayiHuilang Medical Instrument Co., Ltd. to distribute GA-mapTM
Dysbiosis Test in China
Biohit Oyj and Beijing HuayiHuilang Medical Instrument Co., Ltd. signed an
agreement for the distribution of the GA-map(TM) Dysbiosis Test in China.
Ilari Patrakka appointed Biohit Oyj’s Sales and Marketing Director
Ilari Patrakka was appointed Biohit Oyj’s Sales and Marketing Director and as
a member of the Management Team as of August 26th 2016. He holds a Master of
Science (M.Sc.) degree in Business Administration.
Glomedics to distribute Biohit Lactose Intolerance Quick Test in South Korea
Biohit Oyj and Glomedics signed an agreement for the distribution of the Biohit
Lactose Intolerance Quick Test in South Korea.
The first meta-analysis of the scientific studies conducted with GastroPanel®
was completed – the test is accurate for diagnosing atrophic gastritis
The first meta-analysis of the scientific studies conducted with GastroPanel®
test was completed. GastroPanel® is a unique, very informative test for
examining patients with upper stomach problems and diagnosing helicobacter
gastritis (infection) and atrophic gastritis developed from it and stomach
cancer and other risks caused by atrophic gastritis. Atrophic gastritis, which
is usually asymptomatic and which 13C urea breath test, fecal antigen test or
pure antibody tests can not detect, can be detected only with GastroPanel® or
gastroscopy and biopsy examination. Possibly for this reason, a stomach cancer
developed from atrophic gastritis is still diagnosed at late stages, when the
prognosis is very poor (www.biohithealthcare.com/additional-information ).
Biohit Oyj’s Chinese joint venture to start production - Gastric cancer risk
screening study progressing in China
Biohit Oyj’s Chinese joint venture Biohit HealthCare (Hefei) Co. Ltd production
facility passed official test requirements and was granted a license enabling
production and sales of products. Biohit HealthCare (Hefei) Co. Ltd will start
manufacturing of the globally unique GastroPanel®-product developed by Biohit
Oyj for the Chinese market. The first shipments will go to fill orders relating
to the ongoing gastric cancer risk screening study.
Acetium capsule prevents the exposure to carcinogenic acetaldehyde in patients
with atrophy of the stomach mucosa
New scientific evidence on Acetium capsule was obtained. A collaborative study
with Uppsala University shows that Acetium capsule prevents acetaldehyde
exposure in patients suffering from the atrophy of the stomach mucosa (atrophic
gastritis) caused by Helicobacter pylori infection.
Biohit Oyj’s GastroPanel® quick test
GastroPanel® test’s performance and clinical tests as well as registration can
be potentially be completed already during 2017. Thisquick test can be
performed during a clinical appointment from a fingertip blood drop. The new
test is an advanced version of Biohit´s unique GastroPanel® stomach health test
(www.biohithealthcare.com/additional-information). GastroPanel® quick test
differs from the current clinical test version by giving the results
immediately during a single clinical appointment. The GastroPanel® quick test
saves costs and unnecessary clinical appointments as well as speeds up the
referral to further examinations and eventual treatment, which significantly
improves the patient safety.
Biohit Oyj and R-kioski to start cooperation
Biohit Oyj and R-kioski started cooperation. R-kioski will sell and promote the
gift cards for Biohit’s health checks for its consumers in R-kioski convenience
stores across Finland. The agreement will enter into force immediately and will
start with a launch during December 2016.
Biohit Oyj’s Option Scheme I 2013 – Management Option Arrangement
Biohit Oyj’s Board of Directors decided on December 5, 2016 to distribute
option rights of the option scheme I 2013 as follows: Graham Johnson 30.000
pcs, Panu Hendolin 30.000 pcs, Niklas Nordström 30.000 pcs, Daniela Söderström
30.000 pcs and Ilari Patrakka 30.000 pcs. For the option rights share
subscription period commences on January 1, 2017 and ends on May 31, 2019. The
persons have accepted the option rights.
Biohit Oyj’s Financial Reporting and Annual General Meeting in 2017
Biohit Oyj will release its financial statements for 2016 on Monday 20th of
February 2017.The Annual Report, which contains the Financial Statements for
2016 and the Report of the Board of Directors will be published approximately
during week 12. Biohit Oyj’s Annual General Meeting has been planned for
Wednesday 26th of April 2017 at 5:00 pm. Half year financial report for period
January-June (H1) 2017 will be published on Thursday 17th of August 2017.
Possible to send a whole blood sample for GastroPanel® examination
Biohit has now subjected the GastroPanel® examination for further refinements,
of which a patent application has been recently submitted. Now a whole blood
sample can be sent to GastroPanel® examination without additional processing
steps in context of drawing the sample, like centrifugation and transfer of the
plasma (separated from a whole blood sample) into a tube with patient’s data
label. This gives only in Europe the possibility for the thousands of private
practices to take GastroPanel® as part of their test assortment with its
benefits. Furthermore, by collecting whole blood samples, the risk of stomach
and oesophagus cancer, with GastroPanel® screening, which provide plenty of
other information as well, could be even easier to realise in a cost efficient
way (www.gastropanel.com, www.biohithealthcare.com/additional-information ).
MAJOR EVENTS AFTER THE CLOSE OF THE PERIOD
Ownership arrangement in Biohit Oyj’s Chinese Joint Venture – 2017 operating
result expected to be positive
Biohit Oyj and Anhui Wisdom-Win Investment Co. Ltd signed a resolution
authorised by shareholders of Biohit HealthCare (Hefei) Co. Ltd. a joint
venture operating in Hefei, China, concerning reduction of the joint venture
share capital for an amount equal to Biohit Oyj’s shareholding. Biohit Oyj owns
40% of the company, and the agreement is for reduction of the entire share
capital. As a result of the transaction Biohit Oyj estimates its operating
result to turn calculatory positive for 2017. The transaction requires approval
from the authorities.
Biohit Oyj does not classify Biohit HealthCare (Hefei) Co. Ltd shares as an
asset available for sale as the book value of the asset is not in principal
determined by the assets transaction value and the share capital reduction
requires approval from the authorities.
ADMINISTRATION
Biohit's financial reporting and Annual General Meeting in 2017
Biohit Oyj’s Annual General Meeting has been planned for 5.00 pm on Wednesday
26 April 2017 in Helsinki. The Board of Directors will call the General Meeting
at a later date. In 2017 the company will publish the half-year report for
period January - June 2017 (H1) at 9:30 am on Thursday 17 August 2017.
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
Ilari Patrakka, 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 (14,348,533), of which 2,975,500
(2,975,500) are Series A shares and 11,723,033 (11,373,033) 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 88.9 million
(EUR 80.5 million on 31 December 2015). Shares’ trade value during the period
amounted to approximately EUR 12 million.
BIOBV/NASDAQ OMX Helsinki 1-12/2016 1-12/2015
-------------------------------------------------
High (EUR) 6.42 7.14
-------------------------------------------------
Low (EUR) 4.71 4.22
-------------------------------------------------
Average (EUR) 5.57 5.45
-------------------------------------------------
Latest (EUR) 6.05 5.61
-------------------------------------------------
Turnover (EUR) 11,988,747 22,618,230
-------------------------------------------------
Turnover volume 2,158,791 4,014,402
-------------------------------------------------
Shareholders
At the end of the reporting period on 31 December 2016, the company had 6,402
shareholders (6,594 on 31 December 2015). Private households held 76.17%
(78.0%). companies 19.26% (20.1%) and public sector organisations 0.02% (0.0%).
Foreign ownership or nominee registrations accounted for 4.41% (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
This financial statement release has been prepared in accordance with the
requirements of the IAS 34 Interim Financial Reporting standard. Biohit Oyj has
applied the same accounting principles in preparing this financial statement
release as for its financial statements 2015.
The figures in the financial statement release have not been audited.
CONSOLIDATED INCOME STATEMENT
EUR million 7-12/2 7-12/2 Change 1-12/2 1-12/2 Change
016 015 016 015
--------------------------------------------------------------------------------
Net sales 4.4 2.5 1.8 8.2 6.1 2.1
--------------------------------------------------------------------------------
Materials and services -2.2 -1.4 -0.9 -4.0 -2.9 -1.1
--------------------------------------------------------------------------------
Gross margin 2.1 1.2 1.0 4.2 3.2 1.0
--------------------------------------------------------------------------------
Other operating income 0.1 0.7 -0.7 0.1 0.8 -0.6
--------------------------------------------------------------------------------
Sales and marketing -1.1 -1.1 0.1 -2.2 -2.3 0.1
--------------------------------------------------------------------------------
Administration -1.8 -1.2 -0.6 -3.3 -2.4 -0.9
--------------------------------------------------------------------------------
Research and development -0.8 -1.0 0.1 -2.0 -2.0 0.1
--------------------------------------------------------------------------------
Share of profit/loss in Joint 0.2 -0.1 0.3 -0.2 -0.1 -0.1
Venture
--------------------------------------------------------------------------------
Operating profit/loss -1.3 -1.4 0.2 -3.4 -2.9 -0.5
--------------------------------------------------------------------------------
Financial income 0.2 0.1 0.1 0.2 0.2 0.0
--------------------------------------------------------------------------------
Financial expenses 0.0 -0.2 0.2 -0.2 -0.2 0.1
--------------------------------------------------------------------------------
Profit/loss before taxes -1.2 -1.6 0.4 -3.3 -2.9 -0.4
--------------------------------------------------------------------------------
Income taxes 0.0 0.0 0.0 0.0 0.0 0.0
--------------------------------------------------------------------------------
Profit/loss for the period -1.2 -1.6 0.4 -3.3 -2.9 -0.4
--------------------------------------------------------------------------------
Other comprehensive income after
taxes
--------------------------------------------------------------------------------
Other comprehensive income to be
reclassified to profit or loss
in subsequent periods
--------------------------------------------------------------------------------
Available-for-sale financial 0.5 0.0 0.5 1.0 -0.2 1.1
assets
--------------------------------------------------------------------------------
Translation differences 0.0 0.0 0.0 -0.1 0.0 -0.1
--------------------------------------------------------------------------------
Other comprehensive income to be 0.4 0.0 0.5 0.9 -0.2 1.0
reclassified to profit or loss
in subsequent periods
--------------------------------------------------------------------------------
Total comprehensive income for -0.8 -1.6 0.9 -2.4 -3.1 0.7
the period
--------------------------------------------------------------------------------
Earnings per share calculated from earnings attributable to equity holders of
the parent company
1-12/2016 1-12/2015
--------------------------------------------------------
--------------------------------------------------------
Undiluted earnings per share (EUR) -0.22 -0.20
CONSOLIDATED BALANCE SHEET
MEUR 31.12.2016 31.12.2015
--------------------------------------------------------------------------------
ASSETS
--------------------------------------------------------------------------------
NON-CURRENT ASSETS
--------------------------------------------------------------------------------
Intangible assets 1.2 1.4
--------------------------------------------------------------------------------
Tangible assets 0.7 0.8
--------------------------------------------------------------------------------
Share in Joint Venture 0.4 0.6
--------------------------------------------------------------------------------
Other financial long-term assets 0.0 0.0
--------------------------------------------------------------------------------
Deferred tax assets 0.1 0.1
--------------------------------------------------------------------------------
Total non-current assets 2.4 2.9
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
CURRENT ASSETS
--------------------------------------------------------------------------------
Inventories 0.9 0.6
--------------------------------------------------------------------------------
Trade and other receivables 2.0 1.0
--------------------------------------------------------------------------------
Other financial short-term assets 7.1 6.5
--------------------------------------------------------------------------------
Cash and cash equivalents 0.6 0.7
--------------------------------------------------------------------------------
Total current assets 10.6 8.9
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
TOTAL ASSETS 13.0 11.7
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
SHAREHOLDERS' EQUITY AND LIABILITIES
--------------------------------------------------------------------------------
Shareholders' equity attributable to the owners of the
parent company
--------------------------------------------------------------------------------
Share capital 2.4 2.4
--------------------------------------------------------------------------------
Invested unrestricted equity fund 4.3 2.4
--------------------------------------------------------------------------------
Translation differences -0.1 0.0
--------------------------------------------------------------------------------
Retained earnings 4.1 5.6
--------------------------------------------------------------------------------
Total shareholders' equity 10.7 10.3
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
NON-CURRENT LIABILITIES
--------------------------------------------------------------------------------
Deferred tax liabilities 0.4 0.2
--------------------------------------------------------------------------------
Other liabilities 0.0 0.0
--------------------------------------------------------------------------------
Total non-current liabilities 0.4 0.2
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
CURRENT LIABILITIES
--------------------------------------------------------------------------------
Trade payables 1.0 0.3
--------------------------------------------------------------------------------
Total interest-bearing liabilities 0.1
--------------------------------------------------------------------------------
Tax liabilities 0.0 0.0
--------------------------------------------------------------------------------
Other liabilities 0.8 0.8
--------------------------------------------------------------------------------
Total current liabilities 1.8 1.2
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Total liabilities 2.2 1.4
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES 13.0 11.7
--------------------------------------------------------------------------------
STATEMENT OF CHANGES IN EQUITY
Consolidated statement of changes in equity on 31 December 2016
MEUR Share Invested Translati Fair Retained Sharehold
capita unrestricted on value earnings ers'
l equity fund differenc reserve equity
es
--------------------------------------------------------------------------------
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 0.9 0.9
payments
--------------------------------------------------------------------------------
Total -0.1 1.0 -3.3 -2.4
comprehensive
income for the
period
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Shareholders' 2.4 4.3 -0.1 1.0 3.1 10.7
equity 31
December 2016
Consolidated statement of changes in equity on 31 December 2015
MEUR Share Invested Translati Fair Retained Sharehold
capita unrestricted on value earnings ers'
l equity fund differenc reserve equity
es
--------------------------------------------------------------------------------
Shareholders' 2.4 1.9 0.0 0.2 8.2 12.7
equity
1 Jan 2015
--------------------------------------------------------------------------------
Share based 0.2 0.2
payments
--------------------------------------------------------------------------------
Exercise of 0.5 0.5
share options
--------------------------------------------------------------------------------
Total 0.0 -0.2 -2.9 -3.1
comprehensive
income for the
period
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Shareholders' 2.4 2.4 0.0 0.0 5.5 10.3
equity
30 Dec 2015
CONSOLIDATED CASH FLOW STATEMENT
MEUR 1-12/2016 1-12/2015
--------------------------------------------------------------------------------
CASH FLOW FROM OPERATING ACTIVITIES
--------------------------------------------------------------------------------
Loss for the period -3.3 -2.9
--------------------------------------------------------------------------------
Adjustments 1.3 0.0
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Change in working capital -0.5 -0.2
--------------------------------------------------------------------------------
Interest paid and payments on other operating financial -0.1 -0.2
expenses
--------------------------------------------------------------------------------
Interest received 0.3 0.2
--------------------------------------------------------------------------------
Realised exchange rate gains and losses 0.0 0.0
--------------------------------------------------------------------------------
Income taxes paid -0.1 -0.1
--------------------------------------------------------------------------------
Net cash flow from operating activities -2.5 -3.1
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
CASH FLOW FROM INVESTMENTS
--------------------------------------------------------------------------------
Investments in tangible and intangible assets -0.1 -0.2
--------------------------------------------------------------------------------
Proceeds from disposal of tangible and intangible assets 0.0 0.1
--------------------------------------------------------------------------------
Net investments in funds and deposits 2.6 3.0
--------------------------------------------------------------------------------
Net cash flow from investments 2.5 2.9
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
CASH FLOW FROM FINANCING ACTIVITIES
--------------------------------------------------------------------------------
Rights issue 0.5
--------------------------------------------------------------------------------
Repayment of loans -0.1 -0.1
--------------------------------------------------------------------------------
Net cash flow from financing activities -0.1 0.4
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Increase (+)/decrease (-) in cash and cash equivalents -0.1 0.1
--------------------------------------------------------------------------------
Cash and cash equivalents at the beginning of the period 0.7 0.6
--------------------------------------------------------------------------------
Effect of exchange rates on cash and cash equivalents -0.1 0.0
--------------------------------------------------------------------------------
Cash and cash equivalents at the end of the period 0.6 0.7
--------------------------------------------------------------------------------
RELATED PARTY TRANSACTIONS
Biohit Oyj’s goods and service sales for our joint venture Biohit Healthcare
(Hefei) Co. Ltd increased significantly during the financial period compared to
previous year being EUR 3.6 million (EUR 1.4 million in 2015 including the
closely associated company Anhui Machinery Development).
Biohit Oyj B-shares subscribed with stock options I and II 2013 during the
1-12/2016 reporting period
During 2016 no new Biohit Oyj shares were subscribed for with stock options I
2013.
As a result of the directed share issue for Genetic Analysis AS in 2016
(350,000 shares), the total number of Biohit Oyj's shares increased to
14,698,533 (14,348,533 shares December 31, 2015) and B-shares to 11,723,033
(11,373,033 shares December 31, 2015). The new shares will correspond to a
percentage of 2.38% of Biohit Oyj's total number of shares and 0.49% of the
voting rights after registration.
COLLATERAL, CONTINGENT LIABILITIES AND OTHER COMMITMENTS
31.12.2016 31.12.2015
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Collateral granted on behalf of the parent company
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Guarantees 0.1 0.0
--------------------------------------------------------------------------------
Collateral granted on behalf of the subsidiaries
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Guarantees
--------------------------------------------------------------------------------
Other liabilities
--------------------------------------------------------------------------------
Leasing commitments
--------------------------------------------------------------------------------
Due for payment in less than one year 0.1 0.0
--------------------------------------------------------------------------------
Due for payment in more than one year but less than five 0.1 0.0
years
--------------------------------------------------------------------------------
Due for payment in more than five years 0.0 0.0
--------------------------------------------------------------------------------
Total 0.1 0.1
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Other rental commitments
--------------------------------------------------------------------------------
Due for payment in less than one year 0.3 0.2
--------------------------------------------------------------------------------
Due for payment in more than one year but less than five 0.5 0.6
years
--------------------------------------------------------------------------------
Due for payment in more than five years
--------------------------------------------------------------------------------
Total 0.7 0.9
--------------------------------------------------------------------------------
Other contingent liabilities 0.8 0.9
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Collateral and contingent liabilities total 0.9 0.9
--------------------------------------------------------------------------------
NEXT FINANCIAL REPORT
The half-year report for January - June 2017 (H1) will be published at 9:30 am
local time (EEST) on Thursday 17 August 2017.
Helsinki, 20 February 2017
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
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