2016-02-25 08:30:01 CET
2016-02-25 08:30:01 CET
REGLERAD INFORMATION
Biohit Oyj - Financial Statement Release
BIOHIT GROUP FINANCIAL STATEMENT RELEASE 2015
Biohit Oyj Financial Statement Release, 25 February 2016 at 9:30 am local time
(EET)
SUMMARY
January–December 2015
-- Net sales grew by 38.7% compared to 1-12/2014
-- Net sales EUR 6.1 million (EUR 4.4 million)
-- Operating loss, continuing operations, EUR -2.9 million (EUR -4.5 million)
-- The result for the reporting period, continuing operations, EUR -2.9
million
(EUR -4.4 million)
-- The result for the reporting period, discontinued operations, EUR 0 million
(EUR 3.3 million)
-- The result for the reporting period was EUR -2.9 million (EUR -1.2 million)
-- Net sales from international operations 88.3% (91.5%) of total net sales
-- Equity ratio 87.9% (87.5%)
October-December / Q4 2015
-- Net sales grew by 6.0% compared to Q4/2014
-- Net sales EUR 1.2 million (EUR 1.1. million)
-- Operating loss, continuing operations, EUR -1.4 million (EUR -1.2 million)
-- The result for the reporting period, continuing operations, EUR -1.5
million
(EUR -1.2 million)
-- The result for the reporting period was EUR -1.5 million (EUR -1.2 million)
-- Net sales from international operations 88.9% (92.7%) of total net sales
-- Equity ratio 87.9% (87.5%)
PRESIDENT & CEO SEMI KORPELA:
‘In the fourth quarter of 2015 our net sales grew by 6.0% compared to the
comparison period Q4/2014. During the entire year our net sales grew by 38.7%
compared to 1-12/2014. In terms of operational development, Biohit Oyj has
focused on expanding the international distributor network and supporting
partners, for example in product registrations. In addition, we have focused on
increasing and developing of domestic service sales as well as the
commercialisation of our new products. We continued our work to increase
decision-makers’, doctors’ and broader public’s awareness of acetaldehyde. Our
spearhead products are Acetium, GastroPanel and diagnostic quick tests. Main
market areas are Europe and Asia.
We expanded our distributor network and advanced product registrations
We continued expanding our distributor network with new agreements and by
restructuring agreements. During the fourth quarter of 2015 we signed Acetium
lozenge distribution agreement with Birtely Pharma (United Arab Emirates),
Acetium distribution agreements with Queenslabs Lda (Portugal) and with Biomed
S.A. (Spain) and ColonView distribution agreement with Zhejiang Co. Ltd
(China).
In addition, during 2015 we entered among others into the following diagnostics
distribution agreements: Melon OOO (Kazakhstan), Biohemed doo (Serbia, Bosnia
and Herzegovina, Montenegro), Arium Sistemas de Diagnòstico Lda (Portugal),
Gulf Drug LLC (United Arab Emirates), PT. InoDia (Indonesia), Mekalasi
(Finland), Humasis (Korea), HealthLife (Kuwait). We made the following
agreements on Acetium product distribution: Oriola Oy (Finland), Oriola Oy
(Baltic countries), LS Pharma (Italy), Daiichi Sankyo Thailand Ltd (Vietnam,
Laos, Cambodia and Myanmar), El-Alawia Medical Agencies (Sudan). In addition,
we expanded the distribution of Acetium lozenge to dental care in Finland by
beginning a cooperation with Hammasväline Oy.
During 2015 the registration of Acetium capsule was completed in China where
our partner GrandPharma will begin sales of the capsules using the Chinese
brand name Shubang. The capsule binding acetaldehyde into a harmless compound
was registered as a food supplement in Mexico. During the fourth quarter of
2015 the registration of Acetium capsule was completed in Nigeria and in
Kuwait. The registration of the quick tests in Kuwait was also completed. In
general, the duration of the product registration process is different in each
market area. For this reason, it is not possible to accurately assess the time
taken for the authorities to handle registrations in different countries and
for product sales to begin.
During 2015 a price approval decision on the three GastroPanel tests
(pepsinogen l, pepsinogen II, gastrin-17) was issued in four Chinese provinces:
Jilin, Liaoning, Jiangsu and Inner Mongolia. The price approval decision has
already been issued in 11 provinces. Price approval is a pre-requisite for
reimbursability of GastroPanel and start of sales.
We launched new products and expanded service sales
We achieved a significant milestone in R&D operations, when the development of
the unified GastroPanel test was completed. GastroPanel can now be carried out
more cost effectively and easily in the primary health care and screening
processes.
We expanded our product portfolio with a blood sample based vitamin D test and
with a quick test reader, which allows an effective use of Biohit ColonView
Quick Test and Biohit Celiac Disease Quick Test in a point-of-care setting.
Acetium product family grew with a new salty liquorice flavored lozenge. We
also renewed the Acetium lozenge packages.
Biohit expanded pharmacy campaigns providing diagnostic testing of the
gastrointestinal tract across Finland. The campaigns offer testing to enable
diseases to be diagnosed and prevented at an early stage. In Helsinki the
Ympyrätalo Pharmacy offers a similar service for its clients as a part of its
permanent base range. We also began using an electronic appointment-booking
service in Finland.
The Association for Finnish Work granted the Key Flag symbol to Acetium
capsules and Acetium lozenges, indicating that the products originate from
Finland.
We advanced cancer screenings in China and in Russia
We continued our work in order to improve advancements in medical practices,
especially in cancer screenings. China started two gastric cancer risk
screening studies using Biohit Oyj’s GastroPanel test. The first screening
study is a project of the National Clinical Research Center for Digestive
Diseases (Changhai Hospital), and it is funded by the Ministry of Science and
Technology of China, which is the organiser of a multi-center study of early
gastric cancer risk screening. In the study at least 20,000 persons will be
screened in approximately 50 hospitals. The screenings are set to end in
December 2016.
The second study is being conducted in Chinese healthcare centers by the China
Health Promotion Foundation. The foundation is a public organisation, managed
by the Chinese Ministry of Health. Around half a million 40-80-year-old
asymptomatic persons will be screened in the study. The sample collection has
begun in the summer of 2015.
Russian Federation started a pilot project for colorectal cancer screening,
targeted to 48-75-year-old asymptomatic persons. In the project around 20,000
persons will be screened. A screening test will be selected for the project,
based on the results of the study. Biohit Oyj’s ColonView test is one of the
options. The screening project is organised and sponsored by the Russian
Federal Government and it will be performed in local medical clinics.
We made progress in our clinical studies
The first, nearly two-year smoking intervention study by Biohit Oyj was
completed in November 2015. According to some preliminary observations, the
Acetium lozenge containing slowly releasing L-cysteine is a promising novel
method to assist in smoking cessation. This is a new significant indication of
the possible benefit of the product in addition to that it has no side effects
such as with medication and nicotine products, and it binds acetaldehyde
dissolved into saliva from cigarette smoke to form a harmless compound and
promote oral health.
Research results related to acetaldehyde and cancer screenings supported our
operations
The research results related to carcinogenic acetaldehyde and cancer screenings
underlined the importance of our offering as part of the prevention and early
diagnosis of socially important major diseases, especially of ageing
population, and thereby saving costs.
An international study comparing colorectal cancer screening tests was
completed. The results indicated that Biohit Oyj’s ColonView, specific for
human blood, is superior to the conventional tests in colorectal cancer
screening due to its sensitivity and specificity. The scientific report was
published in an international cancer journal Anticancer Research.
In the Congress of the European Society for Biomedical Research on Alcoholism
(ESBRA), a new study was introduced assessing the effect of Acetium lozenges on
salivary acetaldehyde concentrations after consuming alcoholic beverages
containing high and low levels of acetaldehyde. Promising results were gained
with Acetium lozenge in the elimination of carcinogenic acetaldehyde in saliva.
The results of the Japanese–Finnish study were published in PLOS ONE journal.
According to the study, acetaldehyde is a major pathophysiological factor in
gastric carcinogenesis. According to Professor of Internal Medicine,
Gastroenterology and Alcohol Research, Helmut K. Seitz, University of
Heidelberg, the study shows for the first time the role of acetaldehyde in
gastric cancer.
Acetium is used in a Japanese cancer study. According to Professor Katsunori
Iijima, Chief of Gastroenterology Department from Akita University hospital,
the product can be a significant way to prevent cancer. In his new studies, he
will assess the effect of Acetium on acetaldehyde concentrations in esophageal
and gastric mucosa as well as its possible role in prevention of recurrent
cancer among these high-risk patients. Professor Iijima’s team will use also
GastroPanel test developed by Biohit Oyj to estimate the cancer risk in these
patients.
Awareness of acetaldehyde increased
The motion of the European Parliament´s committee on Environment, Public Health
and Food Safety (ENVI) was accepted in May 2015, containing key elements
regarding acetaldehyde. In the motion European Parliament urged the Commission
to immediately ask the European Food Safety Authority (EFSA) to re-evaluate the
use of acetaldehyde as a flavoring substance in alcoholic and non-alcoholic
beverages.
MEPs Against Cancer, an informal group of Members of the European Parliament
committed to actions against cancer, held an expert consultation about alcohol
and cancer. Experts were present from European cancer organisations’ umbrella
organisation European Cancer League and from European Alcohol Policy Alliance
Eurocare that coordinates alcohol policy in the member states of the European
Union. The expert consultation was held due the European Parliament Motion for
a resolution on Alcohol Strategy in which acetaldehyde was featured.
In the light of the existing knowledge, the packaging of alcoholic drinks
should contain a statement on its possible content of acetaldehyde, which is
classified by the WHO as carcinogenic to humans. Given that there is no
scientific evidence to indicate that the acetaldehyde and ethanol in the
foodstuffs are less carcinogenic than the acetaldehyde in alcoholic beverages,
the same requirements should also apply to these products. In 2012, an expert
panel set up by the EU proposed that the acetaldehyde content of cosmetic
products should not exceed 5mg/l, and mouthwashes should not contain any
acetaldehyde. Several foodstuffs have an acetaldehyde content in excess of
5mg/l'.
(http://www.biohithealthcare.com/laboratory-services/determination-of-acetaldehy
de)
THE GROUP’S KEY FIGURES
10-12/2015 10-12/2014 1-12/2015 1-12/2014
--------------------------------------------------------------------------------
Net sales (MEUR) 1.2 1.1 6.1 4.4
--------------------------------------------------------------------------------
Operating profit/loss, -1.4 -1.2 -2.9 -4.5
continuing operations (MEUR)
--------------------------------------------------------------------------------
Profit/loss before taxes (MEUR) -1.4 -1.2 -2.9 -4.3
--------------------------------------------------------------------------------
Profit/loss for the period, -1.5 -1.2 -2.9 -4.4
continuing operations (MEUR)
--------------------------------------------------------------------------------
Profit/loss for the period, 0.0 0.0 0.0 3.3
discontinued operations (MEUR)
--------------------------------------------------------------------------------
Profit/loss for the period, -1.5 -1.2 -2.9 -1.2
total (MEUR)
--------------------------------------------------------------------------------
Average number of personnel 50 50 52 50
--------------------------------------------------------------------------------
Number of personnel at the end 49 51 49 51
of the period
--------------------------------------------------------------------------------
Equity ratio (%) 87.9% 87.5% 87.9% 87.5%
--------------------------------------------------------------------------------
Earnings per share, continuing -0.10 -0.09 -0.20 -0.32
operations (EUR)
--------------------------------------------------------------------------------
Undiluted earnings per share, 0.23
discontinued opearatons (EUR)
--------------------------------------------------------------------------------
Shareholders' equity per share 0.72 0.90 0.72 0.90
(EUR)
--------------------------------------------------------------------------------
Average number of shares during 14,348,533 14,107,125 14,276,519 13,941,286
the period
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Number of shares at the end of 14,348,533 14,135,593 14,348,533 14,135,593
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 38.7% compared with 1-12/2014.
The operating loss from continuing operations was EUR -2.9 million (EUR -4.5
million 1-12/2014). The result for continuing operations during the reporting
period totalled EUR -2.9 million (EUR -4.4 million).
The result for discontinued operations totalled EUR 0.0 million (EUR 3.3
million). In conjunction with the liquid handling business divestment in late
2011, EUR 3.5 million of the gains on sale were not recognised due to the terms
of the sale agreement and other factors, related to the sale, which remained
open at the time. The amount was recognised on 31 March 2014 when the deal was
closed.
The result from continuing operations for the reporting period was EUR -2.9
million (EUR -4.4 million).
Consolidated net sales and result for continued operations
10-12/2 10-12/2 Change 1-12/20 1-12/20 Change
015 014 15 14
--------------------------------------------------------------------------------
Net sales MEUR 1.2 1.1 0.1 6.1 4.4 1.7
--------------------------------------------------------------------------------
Change compared with the 6.0% 38.7%
previous year (%)
--------------------------------------------------------------------------------
Operating income MEUR -1.4 -1.2 -0.2 -2.9 -4.5 1.6
--------------------------------------------------------------------------------
Change compared with the -17.3% 35.6%
previous year (%)
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Operating income -115% -104% -48% -103%
(% of net sales)
BALANCE SHEET
On 31 December 2015, the balance sheet total was EUR 11.7 million (EUR 14.5
million). Biohit's balance sheet provides a solid foundation for building new
business and for fully utilising the significant potential offered by the
company's products. At the end of 2015, our equity ratio stood at 87.9%
(87.5%).
FINANCING
Biohit Oyj has a good financial position, which allows investments in an
international distributor network as well as the development and
commercialisation of new products. Liquidity is at a healthy level. At the end
of the reporting period, the company's financial assets totalled EUR 7.2
million (EUR 10.4 million).
RESEARCH AND DEVELOPMENT
R&D operations focuses on innovations, as well as product development and
improved usability. Biohit also employs external experts and subcontractors in
its R&D operations. Development expenditure has not been capitalised. Research
and development expenditure during the 1-12/2015 reporting period amounted to
EUR 2.0 million (EUR 2.1 million), of which the final quarter accounted for EUR
0.5 million (EUR 0.6 million).
Development activities focused on the GastroPanel Unification Project, which
improved the usability of the test. The unified GastroPanel test kit was
completed in September. In addition, we developed and launched new products.
During 2015 we launched the ELISA-test for the measurement of vitamin D level
from a blood sample (BIOHIT Total25OH vitamin D) and a quick test reader to
assist the evaluation of the ColonView and Celiac Disease Test results.
CLINICAL RESEARCH
During 2015 some twenty clinical trials were ongoing in Finland and abroad with
Biohit’s diagnostic tests and Acetium products.
An international study comparing colorectal cancer screening tests was
completed in the beginning of 2015. The results indicated that Biohit ColonView
is superior to the conventional tests in colorectal cancer screening due to its
sensitivity and specificity. The study compared two colorectal cancer screening
tests based on the detection of fecal occult blood (FOB) in stool samples. A
cohort of 300 patients, all referred for colonoscopy, were examined using the
new-generation Biohit ColonView fecal immunochemical Test (FIT) and a
conventional FOB test. The modern ColonView Quick Test detects both hemoglobin
(Hb) and hemoglobin-haptoglobin (Hb/Hp) complex, whereas the conventional FOB
test is only for the detection of Hb. The scientific report of the study was
published in an international cancer journal Anticancer Research. A study with
a similar design but larger series of patients is progressing well in a major
cancer center in Brazil.
Another major highlight in Biohit Oyj’s Clinical Research was the conclusion of
the smoking intervention study initiated in 2013, assessing the efficacy of the
slowly releasing L-cysteine contained in Acetium lozenge as a novel method to
assist smoking cessation. According to some preliminary observations, the
Acetium lozenge is a promising novel method to assist in smoking cessation. The
efficacy in smoking cessation favorably competes with most of the currently
used smoking intervention methods (ia. nicotine replacement therapy or
medications). Unlike commonly used current intervention methods, the Acetium
lozenge has no side effects or restrictions for use. Great expectations are put
in the future this indication, representing conceptually an entirely novel
method of smoking intervention. The clinical part of the study was concluded in
the beginning of November 2015, followed by submission of the scientific report
to a major international journal in December. If the efficacy can be confirmed
in adequately powered study (approximately a cohort of 1500 smokers) this new
approach represents a breakthrough in the development of smoking intervention
methods.
An international project determining the prevalence of latent B12 vitamin
deficiency and its causes, atrophic gastritis, among over 75-year-olds is
ongoing. The determination is carried out with Biohit’s GastroPanel and B12
vitamin test. The clinical part of the project was completed in Finland during
2015. The results show that the commonness of latent B12 vitamin deficiency
among the elderly is at estimated level. At the same time the results indicate
that serious complications could be prevented with early diagnostics and an
appropriate substitution treatment.
As to the other ongoing research projects, the most advanced ones are the two
randomised, double-blind trials, where the effect of Acetium capsule is
assessed as a new method of prevention of migraine and cluster headaches. Both
are multi-center trials and have been in progress since 2014 in six centers
around Finland.
In addition, a study testing CeliacDisease Quick Test in pediatric patients is
conducted in a children’s hospital in Romania, aiming to enroll a cohort of 100
study subjects.
Towards the end of 2015, the arrangements were completed to start a major
clinical trial with the unified GastroPanel test, validating the new test in
gastroscopy referral patients at GastroCenter of Oulu University Hospital.
Included will be all patients referred for gastroscopy from the primary health
care during one year period. i.e. close to 2000 patients. Once completed, this
extensive study will provide the reference material for the new GastroPanel
test, including the accurate cut-off values for the different diagnostic
categories in a representative Finnish population.
Also, a study testing the efficacy of Acetium capsule in the treatment and
recovery of atrophic gastritis in a double-blind, placebo-controlled setting is
ongoing. The study is conducted in two leading gastroenterology clinics in
Italy (Bologna and Parma). The start of this study was delayed because of the
long lasting approval process. The final results are expected after two years,
because of the nature of the trial, with prolonged follow-up period needed to
confirm the long-term treatment effect.
Acetium capsules’ acetaldehyde-binding properties have been studied in a trial
conducted in Sweden, which confirms the earlier scientific results related to
Acetium. The study showed that Acetium binds 60–80% of the group I carcinogenic
acetaldehyde and creates a harmless MTCA compound that clears from the body.
The report is under an evaluation in an international scientific journal.
INVESTMENTS
Gross investments during the 1-12/2015 reporting period totalled EUR 0.2
million (EUR 0.5 million), of which the fourth quarter accounted for EUR 0.0
million (EUR 0.2 million). Key investments in the period were related to
production automation-related equipment.
PERSONNEL
During the review period, the Biohit Group employed 52 (50 in 2014) people on
average, 44 (41) of whom were employed by the parent company and 8 (9) by the
subsidiaries. At the end of the year 2015, the Group employed 49 (51)
personnel, of whom 40 (42) were employed by the parent company and 9 (9) by the
subsidiaries.
SHORT-TERM RISKS AND UNCERTAINTY FACTORS
Biohit’s key risks have to do with the investments required for business growth
and adequacy of economic resources these require in the medium term. There are
risks involved in areas such as the success of clinical trials, the selection
and development of new market areas and distribution channels, personnel
recruitment, registration processes, product pricing, and political
decision-making affecting the progress of screening programs. Significant
short-term risks are associated with the successful selection of new market
areas, the timing of expansion into selected markets, and product success in
these markets. The recent increase in uncertainty factors associated with
international politics may have an unfavorable impact on the company's
business.
The duration of the product registration process is different in each market
area. For this reason, it is not possible to accurately assess the time taken
for the authorities to handle registrations in these areas and for product
sales to begin.
When investing liquid assets, the objective is to gain a return on investment
with a minimum risk of equity loss. The investment portfolio consists of
deposits, money market investments and corporate loans. A fundamental aspect in
portfolio management is sufficient diversification across different asset
classes, investment instruments and counterparties. Biohit conducts its
investment activities with at least two partners.
Thanks to its wide customer base, Biohit does not materially depend on any
individual customers or project deliveries, with the exception of GastroPanel
sales in China, which currently represents a major business for Biohit. Most of
the company’s business is conducted in euro, and the indirect effects of
currency exchange rate fluctuations are considered minor.
OUTLOOK FOR 2016
Together with its distributors and license partners, Biohit has several product
registrations ongoing in a number of markets, which is affecting net sales
development. A number of such registrations are expected to be completed in
2016. In addition, negotiations are in progress with new partners, including on
the launch of major screening projects, but a number of political risks are
affecting the progress of such projects.
Biohit's cost structure is characterised by high investment in research to
obtain further evidence on the efficacy of Biohit's diagnostic tests in various
clinical settings and in population-based screenings. In 2015 Acetium
double-blind study assessing the efficacy of the product in new indications was
completed. These studies will be continued also in 2016. The unification
project of the GastroPanel test and production investments in Finland were
concluded in 2015. These, strategically significant projects will require
significant additional investments in 2016.
Biohit Biotech (Hefei) Co Ltd is expected to start production in 2016. The
factory is currently producing validation batches in accordance with the
requirement of authorities and after approval the factory can start producing
GastroPanel kits for the Chinese market. The company has also started
recruitment of sales personnel.
We aim to grow profitable and are strongly committed to taking necessary
actions in order to build a profitable future for the company. Net sales growth
is expected in 2016. The company does not assess when the result of its
continuing operations will turn to positive.
BOARD’S PROPOSAL FOR DISTRIBUTIONS OF PROFIT
The parent company's distributable funds (unrestricted equity) on 31 December
2015 are
6,079,716.06, of which the period net loss is 3,526,862.99. The Board of
Directors proposes to the Annual General Meeting that no dividend be paid for
the financial year.
MAIN EVENTS IN THE FOURTH QUARTER
Vitamin D test to complement the diagnostics for osteoporosis and bone fracture
prevention
Biohit Oyj launched a new test for determination of vitamin D from blood
samples. The concentration of 25-OH vitamin D in blood is so far the easiest
and most reliable indicator of biologically active vitamin D levels. Serum
25-OH vitamin D levels reflect the total vitamin D storage of the body and also
correlate with the clinical symptoms of vitamin D deficiency. An adequate
intake of vitamin D helps keeping the bones healthy, as it is the single most
important factor regulating the calcium and phosphate absorption.
Acetium lozenge – a promising novel method to assist smoking cessation
The first, nearly two-year smoking intervention study with Acetium lozenge by
Biohit Oyj was concluded. According to some preliminary observations, the
Acetium lozenge is a promising novel method to assist in smoking cessation.
This was a significant new indication of the product in addition to its ability
to bind carcinogenic acetaldehyde dissolved into saliva from cigarette smoke to
form a harmless compound and thereby promote oral health.
Colorectal screening project started in Russia with Biohit Oyj’s ColonView test
Russian Federation started a pilot project for colorectal cancer screening,
targeted to 48-75-year-old asymptomatic persons. In the project around 20.000
persons will be screened. A screening test will be selected for the project,
based on the results of the pilot phase. Biohit Oyj’s ColonView test is one of
the options. After this, the project will last six years and will include all
18 districts of Saint Petersburg. The screening project is organised and
sponsored by the Russian Federal Government and it will be performed in local
medical clinics.
Acetium® is used in a Japanese cancer study – according to Professor Katsunori
Iijima, the product can be a significant way to prevent cancer
Professor Katsunori Iijima. Chief of Gastroenterology Department from Akita
University hospital (Japan) believes that Biohit Oyj’s Acetium-products
containing slow-release L-cysteine might offer a new means to prevent
esophageal and gastric cancers. Professor Iijima visited Biohit Oyj in November
to introduce his planned new studies. In his new studies, he will assess the
effect of Acetium on acetaldehyde concentrations in esophageal and gastric
mucosa as well as its possible role in prevention of recurrent cancer among
these high-risk patients. Professor Iijima’s team will use also GastroPanel
test developed by Biohit Oyj to estimate the cancer risk in these patients.
Biohit Oyj’s Management Team Option Arrangement
Biohit Oyj’s Board of Directors decided to distribute in total 60,000 option
rights in class I 2013C of the option scheme I 2013 to the members of the
company’s management team excluding the CEO as follows: Hendolin Panu 15,000
pcs, Nordström Niklas 15,000 pcs, Mickels Anu 15,000 pcs and Astola Annika,
15,000 pcs. Each option right entitles its holder to subscribe for one (1) of
the company’s new class B-shares. Share subscription price is 2.2766 euros. The
subscription price can be amended pursuant to the terms and conditions of the
option scheme.
Biohit Oyj changed its financial reporting – in the future, the company will
publish financial reviews twice a year
Biohit Oyj’s board decided in the final meeting of the year that the company
will change its financial reporting schedule from the beginning of 2016. In the
future, Biohit Oyj will publish financial reviews twice a year. This was a
change to the previously published schedule (4.12.2015 Biohit's Financial
Reporting and Annual General Meeting in 2016). Biohit Oyj will publish the
Financial Statement Release for 2015 on Thursday 25th of February 2016, the
Annual Report, including financial statements for 2015 and the Report of the
Board of Directors, approximately during week 12 and the Half-year report for
period January - June 2016 (Q2) on Thursday 18th of August 2016.
MAJOR EVENTS AFTER THE CLOSE OF THE PERIOD
Biohit Oyj bought a share of Norwegian Genetic Analysis AS company with a
directed share issue
Biohit Oyj and Genetic Analysis AS signed a share exchange agreement through
which Biohit Oyj acquired ownership of 18% of shares in the company. In
addition to this the companies signed a distribution agreement giving Biohit
Oyj a right to sell Genetic Analysis AS’s Dysbiosis Test globally under the
Biohit brand and exclusively in Finland and in China. In the future, Genetic
Analysis will also operate as a distributor to Biohit Oyj’s products and
services in Norway.
In consideration, Biohit Oyj issued 350.000 pcs of new Biohit Oyj’s series B
shares to Genetic Analysis AS. The new class B shares were registered with the
Trade Register on February 12, 2016, and the shares carry with them the same
shareholder rights as the outstanding class B shares as of the date of the
registration. The trading in the new shares commenced as of February 15, 2016
on NASDAQ OMX Helsinki together with the outstanding B shares. The arrangements
related to the share exchange have been completed and the new Genetic Analysis
AS shares have been registered in Biohit Oyj’s name.
Biohit Oyj started a confirmatory smoking intervention trial
Biohit Oyj started a confirmatory clinical trial for smoking intervention in
cooperation with research agency Kuulas Helsinki. The aim of the study is to
confirm the promising results obtained in the previous clinical trial aimed at
smoking cessation. If successful, the trial gives adequate power to confirm,
that the Acetium lozenge is a breakthrough in the development of smoking
intervention methods. A cohort of 1,800 voluntary smokers will be invited to
the new study. The study has been started and is expected to be completed
during 2016.
ADMINISTRATION
Biohit's financial reporting and Annual General Meeting in 2016
Biohit Oyj’s Annual General Meeting has been planned for 3.00 pm on Monday 25
April 2016 in Helsinki. The Board of Directors will call the General Meeting at
a later date. In 2016 the company will publish the half-yearly report for
period January - June 2016 (Q2) at 9:30 am on Thursday 18 August 2016.
Biohit Oyj's Management Team
The members of Biohit's Management Team are: CEO Semi Korpela, CFO Niklas
Nordström, Director of Business Development Lea Paloheimo, Production &
Research and Development Director Panu Hendolin, Sales and Marketing Director
Anu Mickels, Quality Director Annika Astola and Chief Medical Director Kari
Syrjänen.
SHARES AND SHAREHOLDERS
Biohit Oyj’s number of shares is 14,348,533 (14,135,593), of which 2,975,500
(2,975,500) are Series A shares and 11,373,033 (11,160,093) are Series B
shares. The Series B shares are quoted on NASDAQ Helsinki in the Small
cap/Healthcare group under the code BIOBV.
Supposing that the market capitalisation for series A and B shares is equal,
the total market capitalisation at the end of the period was EUR 80.5 million
(EUR 66.2 million on 31 December 2014). Shares’ trade value during the period
amounted to EUR 22.6 million.
BIOBV/NASDAQ OMX Helsinki 1-12/2015 1-12/2014
-------------------------------------------------
High (EUR) 7.14 8.17
-------------------------------------------------
Low (EUR) 4.22 4.57
-------------------------------------------------
Average (EUR) 5.45 6.35
-------------------------------------------------
Latest (EUR) 5.61 4.68
-------------------------------------------------
Turnover (EUR) 22,618,230 25,927,811
-------------------------------------------------
-------------------------------------------------
Turnover volume 4,014,402 4,028,617
Shareholders
At the end of the reporting period on 31 December 2015, the company had 6,594
shareholders (6,841 on 31 December 2014). Private households held 78.0%
(77.9%), companies 20.1% (20.1%) and public sector organisations 0.0% (0.0%).
Foreign ownership or nominee registrations accounted for 1.7% (1.8%) of shares.
Further information on the shares, major shareholders and management
shareholdings is available on the company's website at
www.biohithealthcare.com/investors.
ACCOUNTING PRINCIPLES
This financial statement release has been prepared in accordance with the
requirements of the IAS 34 Interim Financial Reporting standard. Biohit Oyj has
applied the same accounting principles in preparing this financial statement
release as for its financial statements 2015.
Joint control in accordance with the IFRS 10 standard fulfilled on part of
Biohit Biotech (Hefei) Co. Ltd. on 30th September 2015 in the way referred to
in the standard and the shareholders’ agreement and the investment is therefore
presented in the balance sheet drawn up according to the new standards and
consolidated in Biohit’s consolidated financial statements using the equity
method. The consolidation had a nonrecurring effect of EUR 0.7 million on the
operating income. Biohit Oyj’s share of the joint venture’s profit/loss is
reported above operating profit.
The figures in the financial statement release have not been audited.
CONSOLIDATED INCOME STATEMENT
EUR million 10-12/ 10-12/ Change 1-12/2 1-12/2 Change
2015 2014 015 014
--------------------------------------------------------------------------------
Net sales 1.2 1.1 0.1 6.1 4.4 1.7
--------------------------------------------------------------------------------
Materials and services -0.8 -0.6 -0.2 -2.9 -1.9 -0.9
--------------------------------------------------------------------------------
Gross margin 0.4 0.6 -0.2 3.2 2.4 0.8
--------------------------------------------------------------------------------
Other operating income 0.0 0.1 -0.1 0.8 0.2 0.5
--------------------------------------------------------------------------------
Sales and marketing -0.6 -0.6 0.0 -2.3 -2.1 -0.3
--------------------------------------------------------------------------------
Administration -0.7 -0.7 0.0 -2.4 -3.1 0.7
--------------------------------------------------------------------------------
Production and product -0.5 -0.6 0.1 -2.0 -2.1 0.0
development
--------------------------------------------------------------------------------
Share of profit/loss in Joint -0.1 -0.1 -0.1 -0.1
Venture
--------------------------------------------------------------------------------
Operating profit/loss. -1.4 -1.2 -0.2 -2.9 -4.5 1.6
continuing operations
--------------------------------------------------------------------------------
Financial income 0.0 0.0 0.0 0.2 0.3 0.0
--------------------------------------------------------------------------------
Financial expenses -0.1 0.0 -0.1 -0.2 -0.1 -0.2
--------------------------------------------------------------------------------
Profit/loss before taxes -1.4 -1.2 -0.3 -2.9 -4.3 1.4
--------------------------------------------------------------------------------
Income taxes 0.0 0.0 0.0 0.0 -0.1 0.1
--------------------------------------------------------------------------------
Income for the period, -1.5 -1.2 -0.2 -2.9 -4.4 1.5
continuing operations
--------------------------------------------------------------------------------
Income for the period, 0.0 0.0 0.0 0.0 3.3 -3.3
discontinued operations
--------------------------------------------------------------------------------
Income for the period, total -1.5 -1.2 -0.2 -2.9 -1.2 -1.8
--------------------------------------------------------------------------------
Other comprehensive income after
taxes
--------------------------------------------------------------------------------
Other comprehensive income to be
reclassified to profit or loss
in subsequent periods
--------------------------------------------------------------------------------
Available-for-sale financial 0.0 0.0 0.0 -0.2 0.1 -0.2
assets
--------------------------------------------------------------------------------
Translation differences 0.0 0.0 0.0 0.0 0.0 0.0
--------------------------------------------------------------------------------
Other comprehensive income to be 0.0 0.0 0.0 -0.2 0.1 -0.2
reclassified to profit or loss
in subsequent periods
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Total comprehensive income for -1.4 -1.2 -0.2 -3.1 -1.1 -2.0
the period
Earnings per share calculated from earnings attributable to equity holders of
the parent company
1-12/2015 1-12/2014
--------------------------------------------------------------------------------
Undiluted earnings per share, continuing operations (EUR) -0.20 -0.32
--------------------------------------------------------------------------------
Undiluted earnings per share, discontinued operations 0.23
(EUR)
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Diluted earnings per share, discontinued operations (EUR) 0.22
CONSOLIDATED BALANCE SHEET
MEUR 31.12.2015 31.12.2014
--------------------------------------------------------------------------------
ASSETS
--------------------------------------------------------------------------------
NON-CURRENT ASSETS
--------------------------------------------------------------------------------
Intangible assets 1.4 1.6
--------------------------------------------------------------------------------
Tangible assets 0.8 0.9
--------------------------------------------------------------------------------
Share in Joint Venture 0.6
--------------------------------------------------------------------------------
Other financial long-term assets 0.0 0.0
--------------------------------------------------------------------------------
Deferred tax assets 0.1 0.0
--------------------------------------------------------------------------------
Total non-current assets 2.9 2.5
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
CURRENT ASSETS
--------------------------------------------------------------------------------
Inventories 0.6 0.8
--------------------------------------------------------------------------------
Trade and other receivables 1.0 0.8
--------------------------------------------------------------------------------
Other financial short-term assets 6.5 9.8
--------------------------------------------------------------------------------
Cash and cash equivalents 0.7 0.6
--------------------------------------------------------------------------------
Total current assets 8.9 12.0
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
TOTAL ASSETS 11.7 14.5
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
SHAREHOLDERS' EQUITY AND LIABILITIES
--------------------------------------------------------------------------------
Shareholders' equity attributable to the owners of the
parent company
--------------------------------------------------------------------------------
Share capital 2.4 2.4
--------------------------------------------------------------------------------
Invested unrestricted equity fund 2.4 1.9
--------------------------------------------------------------------------------
Translation differences 0.0 0.0
--------------------------------------------------------------------------------
Retained earnings 5.6 8.4
--------------------------------------------------------------------------------
Total shareholders' equity 10.3 12.7
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
NON-CURRENT LIABILITIES
--------------------------------------------------------------------------------
Deferred tax liabilities 0.2 0.2
--------------------------------------------------------------------------------
Other liabilities 0.0 0.0
--------------------------------------------------------------------------------
Total non-current liabilities 0.2 0.2
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
CURRENT LIABILITIES
--------------------------------------------------------------------------------
Trade payables 0.3 0.5
--------------------------------------------------------------------------------
Total interest-bearing liabilities 0.1 0.3
--------------------------------------------------------------------------------
Tax liabilities 0.0 0.1
--------------------------------------------------------------------------------
Other liabilities 0.8 0.8
--------------------------------------------------------------------------------
Total current liabilities 1.2 1.6
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Total liabilities 1.4 1.8
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES 11.7 14.5
STATEMENT OF CHANGES IN EQUITY
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 fund 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
31 Dec 2015
Consolidated statement of changes in equity on 31 December 2014
MEUR Share Invested Translati Fair Retained Sharehold
capita unrestricted on value earnings ers'
l equity fund differenc fund equity
es
--------------------------------------------------------------------------------
Shareholders' 2.3 2.8 0.0 0.1 17.2 22.5
equity
1 Jan 2014
--------------------------------------------------------------------------------
Distribution of -10.0 -10.0
dividend
--------------------------------------------------------------------------------
Share based -1.6 2.2 0.5
payments
--------------------------------------------------------------------------------
Exercise of 0.0 0.7 0.8
share options
--------------------------------------------------------------------------------
Total 0.0 0.1 -1.2 -1.1
comprehensive
income for the
period
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Shareholders' 2.4 1.9 0.0 0.2 8.2 12.7
equity
30 Dec 2014
CASH FLOW STATEMENT
MEUR 1-12/2015 1-12/2014
--------------------------------------------------------------------------------
CASH FLOW FROM OPERATING ACTIVITIES
--------------------------------------------------------------------------------
Profit for the period -2.9 -1.2
--------------------------------------------------------------------------------
Adjustments 0.0 -2.5
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Change in working capital -0.2 0.2
--------------------------------------------------------------------------------
Interest paid and payments on other operating financial -0.2 0.0
expenses
--------------------------------------------------------------------------------
Interest received 0.2 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 -3.1 -3.4
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
CASH FLOW FROM INVESTMENTS
--------------------------------------------------------------------------------
Investments in tangible and intangible assets -0.2 -0.4
--------------------------------------------------------------------------------
Revenue from disposal of tangible and intangible assets 0.1 0.0
--------------------------------------------------------------------------------
Capital gain from the sale of liquid handling business 0.0 6.8
--------------------------------------------------------------------------------
Net investments in funds and deposits 3.0 6.5
--------------------------------------------------------------------------------
Net cash flow from investments 2.9 12.9
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
CASH FLOW FROM FINANCING ACTIVITIES
--------------------------------------------------------------------------------
Rights issue 0.5 0.8
--------------------------------------------------------------------------------
Dividend payout 0.0 -10.0
--------------------------------------------------------------------------------
Repayment of capital
--------------------------------------------------------------------------------
Repayment of loans -0.1 -0.1
--------------------------------------------------------------------------------
Net cash flow from financing activities 0.4 -9.4
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Increase (+)/decrease (-) in cash and cash equivalents 0.1 0.1
--------------------------------------------------------------------------------
Cash and cash equivalents at the beginning of the period 0.6 0.5
--------------------------------------------------------------------------------
Effect of exchange rates on cash and cash equivalents 0.0 0.0
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Cash and cash equivalents at the end of the period 0.7 0.6
RELATED PARTY TRANSACTIONS
During the fourth quarter, there were no notable changes in related party
transactions.
Biohit Oyj B-shares subscribed with stock options I and II 2013 during the
1-12/2015 reporting period
A total of 32,940 new Biohit Oyj B-shares were subscribed for with stock
options I 2013 during 2015, and at total of 180,000 new Biohit Oyj B-shares
were subscribed for with stock options II 2013. These shares have been entered
into the trade register and establish equal shareholder rights with the
company's existing B-shares. New shares’ are subject to public trading on the
NASDAQ Helsinki together with the existing B-shares.
The share subscription price for the stock options in question was EUR 2.2766
per share. The entire subscription price was EUR 74,991.20 for the I 2013
option scheme and EUR 407,788 for the II 2013 option scheme, totalling EUR
484,779.2. The amount was entered in the invested non-restricted equity fund
and the company share capital remains unchanged. The shares have no nominal
value.
After the 2015 subscription (212,940 shares), the total number of Biohit Oyj's
shares increased to 14,348,533 (14,135,593 shares December 31, 2014) and
B-shares to 11,373,033 (11,160,093 shares December 31, 2014). The new shares
will correspond to a percentage of 1.48% of Biohit Oyj's total number of shares
and 0.30% of the voting rights after registration.
The share subscription period for stock options I 2013 began on 1 June 2014 and
will end on 31 May 2019. The share subscription period for stock options II
2013 began on 1 July 2013 and ended on 30 June 2015. These schemes are based on
the Biohit Oyj board resolution of 19 June 2013 and the Annual General Meeting
authorisation of 13 April 2011. The terms and conditions of the option schemes
and additional information are available on Biohit Oyj's website at
www.biohithealthcare.com.
To exercise their stock options, holders of stock options must have paid the
subscription price in accordance with the option scheme. Holders exercising
their stock options are liable to pay income tax on the stock option income.
COLLATERAL, CONTINGENT LIABILITIES AND OTHER COMMITMENTS
Dec 31, Dec 31,
2015 2014
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Collateral granted on behalf of the parent company
--------------------------------------------------------------------------------
Corporate mortgages 0.0 0.0
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Collateral granted on behalf of the subsidiaries
--------------------------------------------------------------------------------
Guarantees 0.0 0.0
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Other liabilities
--------------------------------------------------------------------------------
Leasing commitments
--------------------------------------------------------------------------------
Due for payment in less than one year 0.0 0.1
--------------------------------------------------------------------------------
Due for payment in more than one year but less than 0.0 0.1
five years
--------------------------------------------------------------------------------
Due for payment in more than five years 0.0 0.0
--------------------------------------------------------------------------------
Total 0.1 0.2
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Other rental commitments
--------------------------------------------------------------------------------
Due for payment in less than one year 0.2 0.2
--------------------------------------------------------------------------------
Due for payment in more than one year but less than 0.6 0.7
five years
--------------------------------------------------------------------------------
Due for payment in more than five years 0.0 0.1
--------------------------------------------------------------------------------
Total 0.9 1.0
--------------------------------------------------------------------------------
Other contingent liabilities 0.9 1.1
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
Collateral and contingent liabilities total 0.9 1.1
NEXT FINANCIAL REPORT
The half-yearly report for January - June 2016 (Q2) will be published at 9:30
am local time (EEST) on Thursday 18 August 2016.
Helsinki, 25 February 2016
Biohit Oyj
Board of Directors
Additional information:
CEO Semi Korpela
tel. +358 9 773 861
investor.relations@biohit.fi
www.biohithealthcare.com
Biohit in brief
Biohit Oyj is a globally operating Finnish biotechnology company. Biohit
mission is “Innovating for Health” – we produce innovative products and
services to promote research and early diagnosis. Biohit is headquartered in
Helsinki, Finland, and has subsidiaries in Italy and the UK. Biohit Series B
share (BIOBV) is quoted on Nasdaq Helsinki in the Small cap/Healthcare group.
www.biohithealthcare.com
Additional Information.pdf
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