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25.02.2016 09:30

Biohit Oyj Financial Statement Release, 25 February 2016 at 9:30 am local time (EET)
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%)
‘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'
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