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23.10.2014 09:30

Biohit Oyj Interim Report, 23 October 2014 at 9:30 am local time (EEST)
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January–September 2014
  • Net sales grew by 21.0% compared with January-September 2013
  • Net sales EUR 3.2 million (EUR 2.7 million)
  • Operating result, continuing operations EUR -3.3 million (EUR -4.3 million)
  • Result for the reporting period, continuing operations EUR -3.2 million (EUR -4.3 million)
  • Result for the reporting period, discontinued operations EUR 3.3 million (EUR 0.0 million)
  • Total result for the reporting period EUR 0.0 million (EUR -4.3 million)
  • Net sales from international operations 91% (89%) of total net sales
  • Equity ratio 84.1% (80.8%)
July–September / Q3 2014
  • Net sales decreased by 9.9% compared with Q3/2013
  • Net sales EUR 1.2 million (EUR 1.3 million)
  • Operating result, continuing operations EUR -0.9 million (EUR -0.9 million)
  • Result for the reporting period, continuing operations EUR -0.9 million (EUR -0.9 million)
  • Result for the reporting period, discontinued operations EUR 0.0 million (EUR 0.0 million)
  • Total result for the reporting period EUR -0.9 million (EUR -0.9 million)
  • Net sales from international operations 93% (95%) of total net sale)
  • Equity ratio 84.1% (80.8%)
“During the third quarter of 2014, our net sales decreased by 9.9 % year on year. Whereas, unusually large GastroPanel deliveries were made to China during the comparison period in 2013, this year deliveries for orders placed in 2014 have had to be postponed due to a delay in new price approvals in China. Furthermore, during the reporting period a reimbursement decision was issued in four Chinese provinces on the three tests included in Biohit's GastroPanel (PG-I, PG-II, Gastrin-17): the provinces in question were Sichuan, Shandong, Tianjin and Ningxia. A similar decision had previously been issued in the province of Anhui. 
In terms of operational development, Biohit Oyj has focused on supporting its international distributor network, investing in clinical research and preparing for new product launches.
In August, the Chinese health associations – The Chinese Society of Digestive Endoscopy and The Society of Ontological Endoscopy of the Chinese Anti-Cancer Association – issued a consensus clause regarding screening, endoscopic diagnosis and treatment of early gastric cancer in China. This clause recommends serum screening with Pepsinogen-1, Pepsinogen-2, Gastrin-17 and Helicobacter pylori tests that together form GastroPanel® entity. Millions of Chinese people potentially benefit from this consensus clause on the diagnosis of upper abdominal discomfort (dyspepsia) and the screening of asymptomatic patients (e.g. the cancer-causing atrophic gastritis, also known as anacidic stomach, is asymptomatic in most cases, see the attachment: Additional information). This consensus about the novel GastroPanel® approach in gastrointestinal diagnostics clearly shows the forerunner attitude of the Chinese health associations.
After the report period, in October the partners Biohit Oyj and its joint venture Biohit Biotech (Hefei) Co., Ltd agreed to begin a feasibility study in China regarding the Acetium® capsule as a potential medication to arrest the progression and even to restore atrophic gastritis. The agreement includes an option to negotiate a licensing deal concerning the product, if the result of the feasibility study is positive. The feasibility study will be funded by the Chinese partner of the joint venture Biohit Biotech (Hefei) Co., Ltd, in co-operation with Hefei Medicine.
We continued with the marketing of a new diagnostic test, Biohit Active B12, which enables the diagnosis of B12 vitamin deficiency from a venous blood sample. Biohit Active B12 will be released for sale during Q4/2014. Biohit introduced the Calprotectin test on the markets in August 2014. The registration of the acetaldehyde-binding capsule in Mexico has been delayed due to organizational changes in the local register authority.
During the reporting period, we continued to expand our distributor network. We also signed a distributor agreement with the Taiwanese Giraffes Pharmaceutical Company. This agreement entered into force immediately, giving Giraffes Pharma exclusive rights to distribute Acetium ®capsules and the Acetium® lozenge in Taiwan. Biohit Oyj signed a distribution agreement with Eastar Pharmaceuticals LLC, which thereby gained exclusive rights to the distribution of the Acetium®lozenge in China. Chinese registration procedures and distribution channel preparations for the Acetium® lozenge were begun immediately. Centro Prodotti Servizi Farmaceutici S.r.l. was appointed as the distributor of the Acetium®capsule in Italy. In order to boost the sales and marketing of Biohit's antibodies to research institutes and the diagnostics industry, we signed agreements with R&D Systems China in China, Taiwan and Hong Kong. Meditecno Médicos e Sistemade Diagnóstico Lda. is our new distributor of diagnostics products in Portugal, Al Misbar Medical Technology Co. has attained the same rights in Jordan and Ericon S.r.l. is now our distributor of such products in Moldova. Inclino was appointed as the distributor of Biohit quick tests in Norway.
After the report period, we entered into a distribution agreement with JOLI Diagnostics in the United States. This agreement entered into effect immediately and will provide JOLI Diagnostics with exclusive distribution rights for the Biohit lactose-intolerance quick test in the United States. After the report period, Biohemed was appointed as the Serbian distributor of quick tests and acetaldehyde-binding products.
The duration of the product registration process is different in each market area. It is not possible to accurately assess the time it takes to complete all registrations in these markets and to begin generating net sales.
M.Sc. (Tech.), MBA Annika Astola (b. 1974) was appointed Quality Director and a member of the Management Team of Biohit Oyj in August.”
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