Interim / Quarterly Report • Aug 11, 2021
Interim / Quarterly Report
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Biohit Group Half Year Financial Report 2021
Biohit Oyj Half Year Financial Report 11 August 2021 at 9:30 am local time (EET)
SUMMARY
January-June 2021
·
Revenue EUR 4.0 million (EUR 3.0 million)
· Revenue increased by 36% compared to H1/2020
· Operative EBITDA EUR -0.2 million (EUR -1.0 million)
· Cash at the end of the period EUR 1.0 million (EUR 1.0 million 31 December
2020)
· Fair value of Genetic Analysis AS investment EUR 0.8 million (EUR 0.8
million 31 December 2020)
· Revenue from international operations 97.2% (95.6%) of total revenue
· Equity ratio 78.4% (80.8% 31 December 2020)
BIOHIT GROUP KEY FIGURES
1-6/2021 1-6/2020 1-12/2020
Revenue (MEUR) 4.0 3.0 7.1
EBITDA (MEUR) -0.2 -1.0 -1.2
Operative EBITDA (MEUR) -0.2 -1.0 -1.2
Operating profit/loss -1.2 -2.0 -3.2
(MEUR)*
Profit/loss before -1.1 -2.3 -3.3
taxes (MEUR)
Profit/loss for the -1.1 -2.3 -3.3
period (MEUR)
Average number of 46 44 45
personnel
Number of personnel at 48 42 46
the end of the period
Equity ratio (%) 78.4% 81.0% 80.8%
Earnings per share -0.07 -0.15 -0.22
(EUR), Undiluted
Earnings per share -0.07 -0.15 -0.22
(EUR), Diluted
Shareholders' equity 0.51 0.64 0.58
per share (EUR)
Average number of 15,045,593 15,045,593 15,045,593
shares during the
period
Number of shares at the 15,045,593 15,045,593 15,045,593
end of the period
* In 2017 we capitalized the patent regarding divestment of Biohit Healthcare
(Hefei) Co. Ltd. which is depreciated EUR 1.5 million annually until end of
2021.
ACTING PRESIDENT AND CEO OSMO SUOVANIEMI:
SALES INCREASED IN THE FIRST HALF YEAR
Business of Biohit continued its modest recovery in H1/2021 in all market areas.
Our Revenue increased by 36 percent compared to H1/2020. During the review
period Operative EBITDA adjusted for items affecting comparability increased to
EUR -0.2 million (EUR -1.1 million). Our cash at the end of the period remained
at EUR 1.0 million, the same as at the end of the comparison period and the end
of 2020.
We signed a few distribution agreements during the review period.
In H1/2021 Biohit was granted funding for two R&D projects by the European Union
and Business Finland. The total amount of these grant fundings is EUR 0.9
million, of which EUR 0.1 million is deferred as a revenue to the reporting
period. State Treasury of Finland granted Biohit COVID-19 business cost support
worth EUR 0.2 million for inflexible costs. Centre for Economic Development,
Transport and the Environment decided to grant Biohit Oyj EUR 0.2 million
support for corporate development, this support had no financial impact on the
reporting period.
Biohit initiated arbitration proceedings in H1 2021 against Biohit HealthCare
(Hefei) Co. Ltd, who manufactures GastroPanel products and is Biohit’s
distributor in China. A dispute has arisen between the companies regarding the
application of the license agreement concluded between the companies. The target
of the ongoing negotiations is to find an amicable solution without a trial and
to respect the existing contract whilst continuing cooperation with our partner
who was founded and has grown strongly based on GastroPanel products.
Even though Biohit’s business has been challenging due to the COVID-19 pandemic,
we are confident about the future. Our Revenue rose in H1/2021 and we are
constantly working to streamline our cost structure. Operative EBITDA was
negative by only EUR 0.2 million and profit erosion caused by depreciations is
close to its end. In 2017 Biohit capitalized the patent regarding the divestment
of Biohit Healthcare (Hefei) Co. Ltd. These deprectiations will be completed at
the end of 2021.
Biohit has a relatively strong balance sheet and high Equity Ratio (78.4
percent) which create a solid foundation for product and business development.
We have started a development and rationalization program that aims to achieve
more efficient capitalization of the commercial potential of our innovation
portfolio.
OUTLOOK FOR 2021
Biohit expects the 2021 revenue to grow significantly in comparison to 2020
(previous year EUR 7.1 million).
REPORTING
Biohit's product portfolio consists of diagnostic tests, analysis systems,
products binding carcinogenic acetaldehyde into a harmless compound, monoclonal
antibodies, as well as service laboratory operations. The entire product and
service portfolio is reported under a single segment.
REVENUE AND RESULT
January-June
Consolidated revenue
and operating income
1-6/2021 1-6/2020 Change 1-12/2020
Revenue MEUR 4.0 3.0 1.1 7.1
Change compared with 35.7% -39.9% -29.1%
the previous year
(%)
Operating income MEUR -1.2 -2.0 0.9 -3.2
Operating income -28.4% -68.1% -44.6%
(% of revenue)
REVENUE BY MARKET AREA
EUR million 1-6/2021 1-6/2020 1-12/2020
Finland 0.1 0.1 0.3
Europe, other 2.1 1.7 3.6
North and South America 0.2 0.1 0.2
Asia 1.3 0.7 2.4
Other countries 0.4 0.3 0.6
Revenue from contracts with customers 4.0 3.0 7.1
ALTERNATIVE PERFORMANCE MEASURES
Bridge calculation of operative EBITDA
EUR million 1-6/2021 1-6/2020 Change 1-12/2020
Operating profit/loss -1.2 -2.0 0.9 -3.2
Depreciation and amortization 1.0 1.0 -0.0 2.0
Operative EBITDA -0.2 -1.0 0.9 -1.2
BALANCE SHEET, FINANCING AND OPERATIONAL CONTINUITY
On 30 June 2021, the balance sheet totaled to EUR 9.7 million (EUR 10.8 million
31 December 2020). At the end of the review period our company’s equity ratio
was 78.4% (80.8% 31 December 2020).
Our financial position has remained relatively steady regardless of the COVID-19
pandemic. On the 30 June 2021 company’s financial assets totaled EUR 4.8 million
(EUR 5.3 million 31 December 2020) which does not include Genetic Analysis AS
shares.
The company has managed to keep its working capital on a good level and the
management believes that working capital and company’s other financial assets
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. Cash flow from operating activities was EUR -0.4 million during the
review period 1-6/2021. According to company’s management, the 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 AND CLINICAL STUDIES
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 capitalized. Research and
development expenditure excluding depreciation and amortization during the
reporting period H1/2021 amounted to EUR 0.7 million (EUR 0.5 million).
CE mark readiness of the GastroPanel® Quick Test, a test intended for the first
-line diagnosis of dyspepsia, has been demonstrated for a plasma sample with
excellent performance results. The results obtained with the lateral flow based
GastroPanel® Quick Test were in line with those of the ELISA-based GastroPanel®
reference test.
The performance of GastroPanel Quick Test was also compared to the results
obtained from gastroscopy and biopsy in that same study setting. The concordance
between these methods in detecting atrophic gastritis was 95% in specificity and
80% in sensitivity. In the detection of Helicobacter pylori, the agreement
between the methods was also excellent with 85% sensitivity and 97% specificity.
In both study settings, more than 500 patient samples were analyzed, which had
been collected in Finland at Oulu University Hospital from patients suffering
from dyspeptic symptoms in years 2016–2020. The test is now CE marked and we
communicated about it after the close of the review period on the 10[th] of
August 2021.
Our goal is to extend the CE mark of the GastroPanel® Quick Test platform to
also cover finger-prick blood specimens during 2021. Currently, the clinical
study on the finger-prick blood specimens is still suspended due to the COVID-19
pandemic. The study will be continued when it can be performed safely.
The development of the fecal immunochemical test (ColonView-ELISA) designed for
the screening and primary detection of colorectal cancer and its precursors has
continued during 2021.
CORPORATE SOCIAL RESPONSIBILITY, PATIENT SAFETY AND DISEASE PREVENTION
Biohit’s Mission is Innovation for Health. Health promotion innovations are an
essential part of our company’s community responsiveness. Thanks to substantial
investments in biotechnology together with innovation and patenting strategy,
Biohit has launched a wide variety of products that enhance patient safety and
contribute to the primary prevention. The most important ones in this segment
are GastroPanel, ColonView-FIT and Acetium-products.
The unique GastroPanel is a blood test for the primary diagnosis of dyspepsia
and reflux symptoms. GastroPanel has also a significant cost saving feature when
used to screen gastric- and esophageal cancer risks. Screening of gastric and
esophageal cancer, as well as other risks by GastroPanel test would lead to
savings of up to EUR 800 million in the life-time health care costs of 10 age
groups (65-74-year-old) in Finland, according to the screening model designed by
the Nordic Healthcare Group.
It is also advisable to use immunochemical ColonView-FIT-test to detect fecal
occult blood in the primary diagnosis of upper abdominal and reflux symptoms.
The Biohit ColonView-FIT-test, measuring both hemoglobin and hemoglobin
-haptoglobin complex, is more sensitive in the primary diagnostics and also the
test-of-choice for colorectal cancer screening. The test is used to diagnose
intestinal cancer precursors (adenomas and polyps), thus helping to guide in
time for colonoscopy and for further necessary examinations and treatment.
Acetium-capsules bind carcinogenic acetaldehyde in acid-free stomach (due to
atrophic gastritis or PPI-medication), which is a risk factor of stomach cancer.
Accordingly, Acetium-capsules may reduce the risk of gastric cancer associated
with acid-free stomach. Acetaldehyde binding Acetium-capsules may also prevent
the headache attacks in distinct types of migraine.
Acetium lozenge helps quit smoking and possibly also stops alcohol abuse as well
as promoting oral health by eliminating smoke- and alcohol-derived acetaldehyde
in the saliva. Patent has been granted to this invention in 64 countries
www.acetium.com/en (https://eur04.safelinks.protection.outlook.com/?url=http%3A%2
F%2Fwww.acetium.com%2Fen&data=04%7C01%7CJussi.Hahtela%40biohit.fi%7C9cd4c1a4735e4
61a3fbe08d9513d1579%7C4da67d2fc92245f9b72584364b1decf5%7C0%7C0%7C6376301450634576
78%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLC
JXVCI6Mn0%3D%7C1000&sdata=M2gW8RT6oZgH2wAWLBZXlQG1Z8tu49jzuEiH8jNUbwI%3D&reserved
=0).
More information on Biohit’s health promoting innovations can be found at
www.biohithealthcare.com/en (https://eur04.safelinks.protection.outlook.com/?url=
http%3A%2F%2Fwww.biohithealthcare.com%2Fen&data=04%7C01%7CJussi.Hahtela%40biohit.
fi%7C9cd4c1a4735e461a3fbe08d9513d1579%7C4da67d2fc92245f9b72584364b1decf5%7C0%7C0%
7C637630145063457678%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIi
LCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=aUsWl2125AqWsFPD70O%2FJLM86gvJCNWlA9O
49SpVqMg%3D&reserved=0).
INVESTMENTS
Gross investments during the H1/2021 reporting period totaled EUR 0.0 million
(EUR 0.0 million).
PERSONNEL
During the review period, the Biohit Group employed on average 46 (44) people,
of whom 37 (35) were employed by the parent company and 9 (9) by the
subsidiaries.
SHORT-TERM RISKS AND UNCERTAINTY FACTORS
The company’s most significant risks are related to how quickly the global
health care sector recovers from the strain caused by the COVID-19 pandemic.
Slow unloading of accumulated non-COVID related treatment needs and limited
resources might slow down the increase of global demand for Biohit’s product
portfolio.
The selection and development of new market areas and distribution channels as
well as the success of registering new products are central uncertainty factors
for our 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 and for product sales
to begin. The distributor is responsible for the registration process.
Executing the changes demanded by the new EU-directives 2021 (MDR) and 2022
(IVDR) in Biohit’s product portfolio and processes is essential in the short
-term. Regulation requirements must be met to be able to continue selling
existing products.
The prolonged COVID-19 pandemic can increase credit loss risk among Biohit’s
international distribution network.
When investing liquid assets, the objective is to gain a return on investment
with a minimum risk of equity loss. The investment portfolio consists of
deposits, money market investments and corporate loans. A fundamental aspect in
portfolio management is sufficient diversification across different asset
classes, investment instruments and counterparties. The investment portfolio is
subject to interest rate risk, which is managed by adjusting the duration of the
portfolio. In addition, general instability in the financial markets impacts
negatively on the value of the investment portfolio.
The Group’s investment in unlisted shares of Norwegian Genetic Analysis AS is
subject to changes in the terms of transactions involving the company’s shares
that take place between third parties. A negative change of 30% in the valuation
of Genetic Analysis AS shares, would have a negative pre-tax impact of EUR 0.3
million on the Group comprehensive income. Investment in Genetic Analysis AS is
also subject to changes in EUR/NOK foreign exchange rate. In addition, Genetic
Analysis AS is still dependent on securing external financing in its operations.
Genetic Analysis AS valuation changes have no effect on company’s cash flow.
Biohit’s customer base is widely diversified, with the exception of GastroPanel®
sales in China, which currently represents a major single business for Biohit.
For this reason, the company is dependent on the continuation of this business
relationship in China. Also, the success of the arbitration proceedings with
Biohit Healthcare (Hefei) Co. Ltd. is essential in restoring mutual trust. Most
of the company’s business is conducted in EUR, and the indirect effects of
currency exchange rate fluctuations are considered insignificant.
In addition, risks related to recruitment are always present in business.
MAIN EVENTS IN THE FIRST HALF OF THE YEAR (H1)
8.3.2021: European Union and Business Finland provide Biohit Oyj with a total of
EUR 900,000 in financing for product development
Biohit Oyj has received a total of around EUR 900,000 in funding from the EU
through the Eurostars program and also from Business Finland for the development
and launch of rapid tests over the next three years.
The Eurostars program is a joint program of 36 countries managed by the EUREKA
Secretariat in Brussels as part of international EUREKA cooperation. The
financing of the Finnish parties comes from Business Finland. The funding is a
grant primarily to SMEs.
26.3.2021 Biohit’s CEO is on sick leave
Biohit Oyj´s CEO Semi Korpela is on sick leave effective as of 22nd of March
2021. During sick leave, the duties of the CEO are performed by the Chairman of
the Board Osmo Suovaniemi.
8.4.2021 Austell Pharmaceuticals starts as a new distributor of Biohit Oyj’s
GastroPanel[®] test in South Africa
Biohit Oyj and Austell Pharmaceuticals have signed an agreement for the
distribution of the Biohit GastroPanel® test in South Africa.
Austell Pharmaceuticals is a private owned South African company. It has been
the fastest growing pharma company in South Africa for the past 5 years.
20.4.2021 A study from Italy confirms: Low levels of G-17 biomarker of the
Biohit GastroPanel® test predict the risk of esophagitis and esophageal reflux
disease (GERD)
A recent study provided significant new information on the associations of
GastroPanel® G-17 biomarker with esophagitis and gastroesophageal reflux
disease (GERD) symptoms. The Italian study was published by the research group
of Professor Di Mario from Parma University, who has substantial previous
experience on GastroPanel® test (1).
GastroPanel® biomarker test is a unique innovation of a Finnish biotechnology
company (Biohit Oyj, Helsinki), designed for the first-line diagnosis
of Helicobacter pylori (Hp) infection and atrophic gastritis (AG) among the
patients with upper abdominal symptoms (dyspepsia) and esophageal reflux disease
(GERD) in a simple blood test (2,3) (www.gastropanel.com,
www.biohithealthcare.com /News/Links: GastroPanel innovation). At the same time,
GastroPanel® is the only test monitoring the acid output regulatory mechanism in
the stomach. Because Hp and AG as well as high acid output are the most
important risk conditions for gastric and esophageal cancer, the highly
informative GastroPanel® is also particularly suitable for a cost-effective,
population-based screening of asymptomatic individuals for the risk of gastric
and esophageal cancer (2-5,12) (www.biohithealthcare.com/additional
-information4).
Of the four GastroPanel® biomarkers, G-17 is the most multifaceted. Being
synthesized in the gastric antrum, G-17 is a biomarker of its function and
structure: low levels of G-17 can be a sign of antrum atrophy, which is
invariably associated with Hp-infection (6-8). A significantly more common cause
of low G-17 levels, however, is increased gastric acid output, whereas atrophy
of the gastric corpus (with the resulting acid-free stomach) will typically
cause a marked increase of G-17 levels (2,3,6-8,13). Clinically much less
attention has been paid to the regulatory effects of G-17 on the lower
esophageal sphincter muscle. When low G-17 levels are due to increased gastric
acid output, the risk of esophageal reflux disease (GERD) is increased, with
resulting erosive or non-erosive esophagitis, which can develop to Barrett’s
esophagus and lower esophageal cancer (9,10). The following conditions detected
by GastroPanel® test: i) symptomatic Hp-infection after eradication therapy; ii)
AG, or iii) symptomatic high acid output (low G-17). All are indications for
endoscopic examination (www.biohithealthcare.com/additional-information).
26.4.2021 Biohit Oyj comments on the claims presented in public by a member of
Biohit board of directors, Mr. Liu Feng
It is the general policy of Biohit Oyj not to comment on market speculations or
claims presented in public. A member of the Biohit Board of Directors, Mr. Liu
Feng, without prior contact with the company, has presented in public (Helsingin
Sanomat, HS Visio, Kiinalainen juttu, 24.4.2021) claims about Biohit, and we
feel it compulsory to respond to some of the claims presented by Mr. Liu Feng in
the newsprint.
Mr. Liu Feng is the CEO of Biohit HealthCare (Hefei) Co. Ltd and also a member
of the Board of Directors of Biohit Oyj. Biohit HealthCare (Hefei) Co. Ltd is
the single biggest shareholder of Biohit if measured by the number of shares
(32,87% of the shares) and it operates as the exclusive distributor of certain
products of Biohit in China.
Claims presented in public and confidentiality
The claims presented in public by Mr. Liu Feng reflect his private thinking and
do not represent the official views of Biohit.
Biohit considers it is harmful to all parties for Mr. Liu Feng to start a public
discourse on the internal and confidential affairs of Biohit on one hand, and
the bilateral confidential issues related to the distribution agreement on the
other hand. Biohit requires that the interests of the company and individual
shareholders be kept strictly separated, in accordance with the Finnish
Companies Act. In a limited liability company, the responsibility of the Board
of Directors is to promote the interests of the company and make sure, for its
own part, that the demand of an equal treatment of all shareholders will be
realized in full.
The relationships between the company and the Chinese distributor
In the past, Biohit HealthCare (Hefei) Co. Ltd was a joint venture of Biohit Oyj
and Anhui Wisdom-Win Investment Co. Ltd. In 2016, Biohit withdrew from the joint
venture, concurring the signing of the agreement between Biohit and Biohit
HealthCare (Hefei) Co. Ltd:n concerning the exclusive distribution rights in the
Chinese markets.
Biohit and Biohit HealthCare (Hefei) Co. Ltd. have had disagreements as Biohit
requires Biohit HealthCare (Hefei) Co. Ltd. to comply with the terms of the
agreements between the companies. Biohit hopes that the disagreements will be
resolved amicably.
The Corporate Governance
Biohit’s Board of Directors is assembled regularly, and the corporate governance
model of the company follows the Companies Act and rules and regulations of
Nasdaq Helsinki. The details of the company’s governance model are described in
the annually published corporate governance statement. The model of corporate
governance of Biohit deviates in some parts from the Finnish corporate
governance code of listed companies and these nonconformities appear in the
statement.
The Annual General Meeting is held in accordance with the Finnish Companies Act,
and at the event all shareholders have the right to receive information, present
their views and impact decision in accordance with the Finnish Companies Act.
Biohit considers that due to his long experience, Osmo Suovaniemi has excellent
capabilities in successfully undertaking his responsibilities as Chairman of the
Board and also as a deputy of the CEO. Biohit endeavors to promote equality and
deters all type of discrimination, including that based on age.
17.5.2021 Biohit corporation initiates arbitration proceedings concerning a
breach of the license agreement
Biohit Oyj's shareholder Biohit HealthCare (Hefei) Co. Ltd is the exclusive
distributor of Biohit Oyj's Gastropanel products in China. In this connection, a
dispute has arisen between the companies regarding the application of the
license agreement concluded between the companies. Biohit HealthCare (Hefei) Co.
Ltd has not paid royalties to Biohit Oyj in accordance with the distribution and
licensing agreements. In order to resolve these and certain other controversies
and claims related to the license agreement, Biohit Oyj has submitted an
application to the Arbitration Institute of the Finland Chamber of Commerce to
initiate arbitration proceedings.
The impact of unpaid royalties has so far been insignificant for Biohit Oyj's
operations, but as the situation continues, the significance of the matter will
increase.
Biohit HealthCare (Hefei) Co. Ltd was previously a joint venture of Biohit Oyj.
Biohit Oyj exited the joint venture in 2016, when Biohit Oyj and Biohit
HealthCare (Hefei) Co. Ltd entered into an Exclusive Distribution Agreement for
the distribution of GastroPanel in China.
Biohit HealthCare (Hefei) Co. Ltd is the largest shareholder in Biohit Oyj in
terms of the number of shares (32.87 percent of the B-shares). Biohit HealthCare
(Hefei) Co. Ltd's CEO Liu Feng is also a member of Biohit Oyj's Board of
Directors.
17.5.2021 Biohit Oyj’s President and CEO Semi Korpela to leave the company
Biohit Oyj’s Board of Directors has decided that Semi Korpela will immediately
leave the company as the President and CEO. The Board of Directors will commence
a recruitment process for a new CEO and Biohit’s Chairman of the Board Osmo
Suovaniemi will continue as deputy CEO.
21.5.2021 Changes to Biohit Oyj’s management
Biohit Oyj CFO Jukka Kainulainen has decided to leave the company in June 2021.
Search for the new CFO has started.
24.5.2021 Changes to Biohit Oyj’s management
Master of Social Sciences Jussi Hahtela (b. 1973) has been appointed Chief
Financial Officer and as a member of the Management Team of Biohit Oyj starting
June 4th 2021. He will also be responsible for HR function and IT function.
Hahtela will report to deputy CEO Osmo Suovaniemi. Hahtela has previously worked
in Nordea for example as chief strategist and Head of FX sales Finland.
28.5.2021 Publication of Biohit Oyj Renumeration Report 2020
Biohit Oyj’s Remuneration Report for the Governing Bodies is published today in
PDF format. The Remuneration Report for the Governing Bodies is attached to this
stock exchange release and also available at
https://www.biohithealthcare.com/en/investors/.
23.6.2021 Decisions of the Annual General Meeting of Biohit Oyj
The Annual General Meeting (AGM) of Biohit Oyj held on Wednesday June 23, 2021
approved the financial statements for the financial year 2020 with a unanimous
decision of the shareholders participating in the AGM. Based on a vote the AGM
decided not to discharge the members of the Board of Directors and the President
and CEO from liability for the financial year 2020. Based on a vote the AGM
decided to approve the Remuneration Report of the company’s Governing Bodies
presented to the AGM; the decision is advisory.
Distribution of dividends
With a unanimous decision of the shareholders participating in the AGM the AGM
resolved in accordance with the proposal of the Board of Directors that no
dividend is paid for the financial period ended on December 31, 2020.
Members of the Board of Directors
Based on a vote the AGM resolved that six (6) members are elected to the Board
of Directors and that professor Osmo Suovaniemi, CEO Franco Aiolfi, emeritus
professor Matti Härkönen, Commercial Counsellor Eero Lehti, Ph.D. Lea Paloheimo
and CEO Liu Feng are elected as members of the Board of Directors until the end
of the next AGM.
Additionally, the AGM resolved based on a vote that the Chairman of the Board of
Directors and the other members of the Board of Directors are paid a meeting fee
of EUR 1,500.
Election of the Auditor and remuneration for the Auditor
With a unanimous decision of the shareholders participating in the AGM the AGM
elected authorized public accountants PricewaterhouseCoopers Oy as the company’s
auditor until the end of the next AGM and that the auditor is paid remuneration
according to invoice approved by the company.
28.6.2021 Changes in Management Team
Biotechnology and food engineer, Production Manager Suvi Elomaa starts on 1st of
July as Biohit's Production Director and part of the Management Team. Suvi
Elomaa has worked at Biohit since 2013.
Adjunct professor in molecular microbiology, PhD, and computer science engineer
Minna Mäki continues as company’s R&D Director and part of the Management Team.
The change is part of Biohit's operational development program.
29.6.2021 Constitutive meeting of Biohit Oyj’s Board of Directors
Biohit Oyj’s Board of Directors has in its meeting on June 28, 2021 elected
Commercial Counsellor Eero Lehti as the Chairman of the Board of Directors.
MAJOR EVENTS AFTER THE CLOSE OF THE REVIEW PERIOD
29.7.2021 Päivi Siltala new CEO of Biohit Oyj
The Board of Directors of Biohit Oyj has appointed MA Päivi Siltala the CEO of
the company starting September 1, 2021. Siltala is joinig Biohit from Johnson &
Johnson where she has been Sales Director.
Siltala is an experienced biotechnology professional with a large international
contact network. She also has a solid track record in managing business
development and growth. Siltala has worked in Biohit 2008-2010 and thus knows
the company and the technology, which speeds up operative integration.
“Siltala’s experience in biotechnology and personal qualities and skills makes
her excellent person to lead and develop Biohit business and operations to
materialize company’s commercial potential in the best possible way”, says Eero
Lehti, Chairman of the Board of Directors.
Beside Biohit and Johnson & Johnson, Siltala has worked in leading sales and
business development positions at Pentax Medical and Cook Medical Endoscopy.
10.8.2021 CE marked GastroPanel® quick test on the market
The latest innovation in the unique Biohit GastroPanel product family,
GastroPanel quick test, is now CE marked.
We are excited to launch the GastroPanel quick test system with such excellent
performance characteristics and fast turnaround time. We believe that the test
system will be well received by end users because the usability of the test
system enables first-line diagnosis and screening of dyspeptic patients easier
than ever before. We are eager to continue developing the testing system
further. Next, we will extend the CE mark of the GastroPanel quick test to
include finger-prick blood samples by the end of 2021.
ADMINISTRATION
Biohit Oyj's Management Team
The members of Biohit’s Management Team are: Acting CEO Osmo Suovaniemi, CFO
Jussi Hahtela (started on June 4, 2021), Production Director Suvi Elomaa
(started on July 1, 2021), Research and Development Director Minna Mäki
(Production and R&D Director until June 30, 2021), Sales and Marketing Director
Ilari Patrakka and Quality and Regulatory Affairs Director Daniela Söderström.
SHARES AND SHAREHOLDERS
Biohit Oyj’s number of shares is 15,045,593 (15,045,593) of which 2,975,500
(2,975,500) are Series A shares and 12,070,093 (12,070,093) are Series B shares.
The Series B shares are quoted on NASDAQ Helsinki in the Small cap/Healthcare
group under the code BIOBV.
BIOBV/NASDAQ OMX Helsinki 1-6/2021 1-6/2020 1-12/2020
High (EUR) 2.54 4.16 4.30
Low (EUR) 1.97 1.95 1.90
Average (EUR) 2.15 2.93 2.56
Latest (EUR) 2.10 2.44 2.48
Turnover (EUR) 4,772,398 8,141,846 14,153,206
Turnover volume 2,215,947 2,781,524 5,518,054
Shareholders
At the end of the reporting period on 30 June 2021, the company had 7,706
shareholders (7,336 on 30 June 2020). Private households held 59.6% (63.4%),
companies 7.1% (7.5%) and public sector organisations 0.0% (0.0%). Foreign
ownership or nominee registrations accounted for 33.2% (29.1%) of shares.
Further information on the shares, major shareholders and management
shareholdings is available on the company's website.
ACCOUNTING PRINCIPLES
This half year financial 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 half year financial
report as for its financial statements 2020 except for IFRS standard changes and
interpretations implemented in 2021. Changes in new IFRS standards and
interpretations has no material impact in this half year financial report. In
addition, Biohit Oyj has applied IAS20 standard regarding public funding in
review period. The figures in the half year financial report have not been
audited.
In the first half of the year Biohit received funding for the development and
launch of quick tests from the European Union and Business Finland. The funding
amounts to EUR 0.9 million, of which EUR 0.1 million is deferred to the review
period. The accrual for the review period has been included in other operational
income. By 30 June 2021 EUR 40 thousand of the funding has been paid, the rest
has been included in accrued income. The project funded by Business Finland ends
on 31 December 2022 and the one funded by the European Union on 31 January 2024.
Biohit Oyj got a decision of EUR 0.2 million COVID-19 business cost support from
the State Treasury of Finland to cover inflexible costs. The business cost
support has been included to net other operating expenses.
The Center for Economic Development, Transport, and the Environment granted
Biohit Oyj a development amendment totaling EUR 0.2 million. The project must be
executed by 31 March 2022, the amendment did not have any financial impact
during the review period.
Alternative performance measures and items affecting comparability:
Biohit Group presents certain alternative performance measures to reflect the
underlying business performance and to enhance comparability between financial
periods in accordance with ESMA’s (European Securities and Markets Authority)
guidance. Alternative performance measures should not be considered in isolation
as a substitute for measures of performance in accordance with IFRS. Operative
performance measures have been adjusted for certain non-operative items or non
-cash valuation items that affect comparability between periods.
Certain items that are not related to the underlying business or non-cash
valuation items that have material effect on the profit and loss for the period
are adjusted as items affecting comparability. These items can arise, for
example from:
Impairment of assets
Sale or acquisition of asset or business
Share based payment expenses in accordance with IFRS 2
Additionally Biohit Oyj presents the following alternative performance measures:
EBITDA EBIT + depreciation and
amortization
Operative EBIT + depreciation and
EBITDA amortization – Items affecting
comparability
CONSOLIDATED INCOME STATEMENT
EUR million 1-6/2 1-6/2 Change 1-12/
021 020 2020
Revenue 4.0 3.0 1.1 7.1
Change in inventories of finished goods and work -0.2 0.1 -0.3 0.1
in progress
Other operating income 0.1 0.0 0.1 0.0
Materials and services -1.4 -1.4 0.0 -3.3
Employee benefit expenses -1.7 -1.6 -0.1 -3.1
Other operating expenses -1.0 -1.1 0.1 -2.1
EBITDA -0.2 -1.0 0.9 -1.2
Depreciation and amortization -1.0 -1.0 0.0 -2.0
Operating profit/loss -1.2 -2.0 0.9 -3.2
Financial income 0.1 0.0 0.1 0.1
Financial expenses 0.0 -0.3 0.3 -0.2
Profit/loss before taxes -1.1 -2.3 1.3 -3.3
Income taxes -0.0 -0.0 -0.0 -0.1
Profit/loss for the financial period -1.1 -2.3 1.2 -3.3
Items of comprehensive income that may later be
reclassified through profit or loss
Translation differences 0.0 -0.0 0.0 -0.0
Items that will not be reclassified to profit or
loss
Changes in the fair value of equity investments 0.0 -2.7 2.7 -2.6
at fair value through other comprehensive income
Other comprehensive income total 0.0 -2.7 2.7 -2.6
Comprehensive income for the period -1.1 -5.0 4.0 -5.9
Earnings per share calculated from earnings attributable to the owners of the
parent company
1-6/2021 1-6/2020 1-12/2020
Undiluted earnings per share, (EUR) -0.07 -0.15 -0.22
Diluted earnings per share, (EUR) -0.07 -0.15 -0.22
CONSOLIDATED BALANCE SHEET
EUR million 30 June 2021 30 June 2020 31 Dec 2020
ASSETS
NON-CURRENT ASSETS
Intangible assets 0.9 2.6 1.8
Property, plant and equipment 0.2 0.3 0.3
Right-of-use assets 0.4 0.3 0.4
Other financial long-term assets 0.1 0.1 0.1
Deferred tax assets 0.0 0.0 0.0
Total non-current assets 1.7 3.3 2.5
CURRENT ASSETS
Inventories 1.0 1.3 0.9
Trade and other receivables 1.4 1.5 1.3
Other current financial assets 4.7 4.8 5.0
Cash and cash equivalents 1.0 1.0 1.0
Total current assets 8.1 8.6 8.3
TOTAL ASSETS 9.7 11.8 10.8
SHAREHOLDERS' EQUITY AND
LIABILITIES
Shareholders' equity attributable
to the owners of the parent
company
Share capital 2.4 2.4 2.4
Fair value reserve -1.1 -1.3 -1.2
Invested unrestricted equity fund 5.1 5.1 5.1
Translation differences -0.1 -0.1 -0.1
Retained earnings 1.4 3.5 2.5
Total shareholders' equity 7.6 9.6 8.7
NON-CURRENT LIABILITIES
Lease liabilities 0.2 0.1 0.1
Deferred tax liabilities 0.0 0.0 0.0
Other liabilities 0.0 0.0 0.0
Total non-current liabilities 0.2 0.1 0.1
CURRENT LIABILITIES
Trade payables 0.5 0.6 0.6
Tax liabilities 0.0 0.0 0.0
Lease liabilities 0.2 0.2 0.3
Other liabilities 1.1 1.3 1.0
Total current liabilities 1.9 2.1 1.9
Total liabilities 2.1 2.3 2.1
TOTAL SHAREHOLDERS' EQUITY AND 9.7 11.8 10.8
LIABILITIES
STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
Statement of changes in consolidated shareholders' equity on 30 June 2021
EUR million Share Invested Translation Fair Retained
Shareholders'
capital unrestricted differences value earnings equity
equity fund reserve
Shareholders' 2.4 5.1 -0.1 -1.2 2.5
8.7
equity
1 Jan 2021
Total 0.0 0.0 -1.1
-1.1
comprehensive
income for
the
period
Shareholders' 2.4 5.1 -0.1 -1.1 1.4
7.6
equity
30 June 2021
Statement of changes in consolidated shareholders' equity on 30 June 2020
EUR million Share Invested Translation Fair Retained
Shareholders'
capital unrestricted differences value earnings equity
equity fund reserve
Shareholders' 2.4 5.1 -0.1 1.4 5.8
14.6
equity
1 Jan 2020
Total -0.0 -2.7 -2.3
-5.0
comprehensive
income for
the
period
Shareholders' 2.4 5.1 -0.1 -1.3 3.5
9.6
equity
30 June 2020
FINANCIAL ASSETS MEASURED AT FAIR VALUE 30 JUNE 2021
The Group categorized Fair value through Fair value Hierarchical
its financial assets profit and loss through OCI level
and liabilities into MEUR MEUR
the following
categories
Current assets
Other current 1.6 Level 1
financial assets
Other current 2.1 Level 2
financial assets
Other current 0.1 Level 3
financial assets
Other current 0.8 Level 3
financial assets
Total 3.8 0.8
FINANCIAL ASSETS MEASURED AT FAIR VALUE 30 JUNE 2020
The Group categorized Fair value through Fair value Hierarchical
its financial assets profit and loss through OCI level
and liabilities into MEUR MEUR
the following
categories
Current assets
Other current 1.4 Level 1
financial assets
Other current 2.5 Level 2
financial assets
Other current 0.1 Level 3
financial assets
Other current 0.8 Level 3
financial assets
Total 4.0 0.8
The company has classified the hierarchies of financial assets according
to the availability of data on market terms and other price data.In
significant part, the fair values of level 2 instruments are based on
other input data than the quoted prices included in level 1, although
this data can be obtained for the assets or liabilities in question
either directly (as a price) or indirectly (as a derivative of the
price). The Group uses generally accepted valuation models to determine
the fair values of these instruments, and the input data for these
models are based in significant part on observable market data.The level
in the fair value hierarchy at which a certain item measured at fair
value is classified overall is determined on the basis of the
significant input data on the lowest level with regard to the entire
item measured at fair value. The significance of input data is evaluated
in its entirety in relation to the item valued at fair value.The book
value of trade and other receivables and payables and cash and cash
equivalents which are measured at amortized cost corresponds to their
fair value due to their short maturities.Other current financial assets
on level 1 and 2 consists of fixed income funds and corporate loans.
Other current financial assets on level 3 consists of the Group’s
investment in unlisted shares of Genetic Analysis AS. In addition one of
the corporate loans is categorized on level 3.
CASH FLOW STATEMENT
EUR million 1-6/2021 1-6/2020 Change 1-12/2020
CASH FLOW FROM OPERATING
ACTIVITIES
Profit for the period -1.1 -2.3 1.2 -3.3
Adjustments
Depreciation 1.0 1.0 -0.0 2.0
Income taxes 0.0 0.0 0.0 0.1
Other adjustments -0.1 0.3 -0.4 0.1
Change in working capital -0.3 0.9 -1.2 1.3
Interest paid and payments on -0.0 -0.0 0.0 -0.1
other operating financial
expenses
Interest received 0.0 0.0 -0.0 0.1
Realised exchange rate gains and 0.0 -0.0 0.0 -0.0
losses
Income taxes paid 0.0 -0.1 0.1 -0.1
Net cash flow from operating -0.4 -0.2 -0.2 -0.0
activities
CASH FLOW FROM INVESTMENTS
Investments in tangible and -0.0 -0.0 0.0 -0.0
intangible assets
Investments in funds and -0.3 -0.2 -0.1 -1.6
deposits
Profit from the sale of 0.8 0.2 0.6 1.5
investments in funds and
deposits
Net cash flow from investments 0.5 -0.0 0.5 -0.0
CASH FLOW FROM FINANCING
ACTIVITIES
Repayment of lease liabilities -0.1 -0.1 -0.0 -0.2
Net cash flow from financing -0.1 -0.1 -0.0 -0.2
activities
Increase (+)/decrease (-) in -0.1 -0.4 0.3 -0.3
cash and cash equivalents
Cash and cash equivalents at the 1.0 1.3 -0.3 1.3
beginning of the period
Effect of exchange rates on cash 0.0 -0.0 0.0 -0.0
and cash equivalents
Cash and cash equivalents at the 1.0 1.0 -0.0 1.0
end of the period
RELATED PARTY TRANSACTIONS
Biohit Oyj sold EUR 1.1 million (EUR 0.5 million) worth of goods and services to
Biohit Healthcare (Hefei) Co. Ltd during the review period. Biohit Healthcare
(Hefei) Co. Ltd has significant influence in Biohit Oyj in accordance with IAS
28.
COLLATERAL, CONTINGENT
LIABILITIES, AND OTHER
COMMITMENTS
EUR million 30 June 2021 30 June 2020 31 Dec 2020
Collateral granted on
behalf of the parent
company
Guarantees 0,0 0,0 0,0
Collateral and contingent 0,0 0,0 0,0
liabilities total
NEXT FINANCIAL REPORT AND 2022 FINANCIAL REPORTING
Biohit will publish a schedule for 2022 financial reporting and Annual General
Meeting later this year.
Helsinki 11 August 2021
Biohit Oyj
Board of Directors
Additional information:
Acting President and CEO Osmo Suovaniemi
tel. +358 9 773 861
[email protected]
www.biohithealthcare.com
Biohit Oyj in brief
Biohit is a globally operating Finnish biotechnology company. Biohit mission is
“Innovating for Health” – we produce innovative products and services to promote
research and early diagnosis. Biohit is headquartered in Helsinki, Finland, and
has subsidiaries in Italy and the UK. Biohit Series B share (BIOBV) is quoted on
Nasdaq Helsinki in the Small cap/Healthcare group. www.biohithealthcare.com
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