Press release of annual earnings figures for the financial year 2000

Biolight International AB (publ) Press release of annual earnings figures for the financial year 2000 · Studies have been carried out within all the three business areas, Wound Care, Dental Care and Physiotherapeutic Care, and the results have been good. · In the completed phase III study, BL-034, on the healing of decubitus ulcers, grade 2, the last patient finished treatment on January 16, 2001. A statistical report is expected to be ready in March 2001. · A phase III study on patients with gingivitis (inflammation of the gums) was presented in June. The study shows a statistically significant difference in reduction of gingivitis in the patients treated with Biolight®(87 %), in comparison to placebo-treated patients. · The German sports centres that have been trying Biolight® for the rehabilitation of acute sports injuries since February 2000, report very good treatment results. The company is currently examining the possibilities for distribution in Germany. · The company was quality certified according to ISO 9001 on June 28, 2000. · Biolight® WCD (Wound Care Device) and Biolight® DCD (Dental Care Device) were approved according to the medical device directive on June 28, 2000. This means that the company has a CE marked product, ready for sale. · Biolight® PCD (Physiotherapeutic Care Device) - a new device for the treatment and rehabilitation of sports injuries - is currently passing the final tests for CE marking. This work is expected to be completed in March 2001. · The company filed a 510(k) application with the FDA in February 2001 for the business area dental care. An approval from FDA is a basic requirement for selling products in the American market. 510(k) is a simplified registration procedure. · The patent situation of the company has been reinforced through further approvals in several countries, and more patent applications have been submitted. · Discussions are ongoing with international companies regarding commercialization and distribution within the wound care sector. · The new issue, authorized by the annual general meeting, was floated in June. The issue, amounting to SEK 40 million, was directed to international and Swedish institutional investors. Company focus in 2000 During the year, the company focused on developing and verifying the treatment programs within its core areas, as well as preparing for the commercialization of Biolight® within these areas. Development of treatment equipment, quality certification of the company and CE marking of the treatment equipment have been important milestones. Discussions conducted with potential partners for marketing and distribution have also been given high priority. New issue To fund the commercialization, and simultaneously accelerate the development speed, a directed new issue was floated in June, in accordance with the authorization of the annual general meeting held on May 4, 2000. The total liquidity of the issue amounted to SEK 40 million. The issue was directed to international and Swedish institutional investors. Important events after 2000 In January 2001, a Technical Director was employed. His responsibilities include production, logistics and maintaining the quality of the Company's products and systems. In January 2001, the Company was granted another two patents in the USA. The company filed a 510(k) application with the FDA in February 2001 for the business area "Dental Care". Scientific results and research programs BL-032, Gingivitis During the second quarter 2000, a double-blind, randomized, placebo- controlled phase III study on patients with gingivitis (inflammation of the gums) was completed. The study included 86 patients. The object of the study was to examine the effects of treatment with Biolight® on gingivitis. The study showed a very good result. The inflammation of the gum was reduced by 87 % more (p?0,035) in patients treated with Biolight®, than in placebo-treated patients. The study also showed that the more pronounced the inflammation, the greater the amelioration achieved after treatment with Biolight®. The results are statistically significant. The clinical report is completed. BL-034, Decubitus ulcers In the ongoing phase III study, BL 034, on the healing of decubitus ulcers, grade 2, all the patients have been included (n=87; "intention to treat"). The last patient completed treatment on January 16, 2001. A statistical report is expected to be ready in March 2001. Quality certification The process of quality certification according to ISO 9001, which started in the beginning of 1999, is now completed. LRQA - Lloyd's Register Quality Assurance, our notified body - has carried out the last part of the audit. The outcome of the audit was most satisfactory, and the company was approved for certification on June 28, 2000. LRQA carried out a "Routine Surveillance" on January 17, 2001. Market approval Through the quality certification, and as the new device was approved according to MDD 93/42/EEC, the company now has a CE marked product, ready for sale in the EU countries. The company filed a 510(k) application with the FDA in February 2001 for the business area dental care. An approval from the FDA is a basic requirement for sales and marketing in the American market. 510(k) is a simplified registration procedure. Biolight® Physiotherapeutic Care The German sports centres which have been trying Biolight® since February for the rehabilitation of acute sports injuries, report very good treatment results. The company is currently examining the possibilities for distribution in Germany. Biolight® PCD (Physiotherapeutic Care Device) - a new device for the treatment and rehabilitation of sports injuries - is currently passing the final tests for CE marking. This work is expected to be completed in March 2001. Patents During the financial year 2000, the patent protection was reinforced through four new patents, two of them in China and two in Canada. The company also had another two patents approved in the USA in January 2001. In addition to these, the company holds four patents in Sweden and two in the USA. The approved patents are valid until 2014-2016. The patents relate to the technology for generating and pulsating light, to get the wanted effect during treatment. International applications regarding these patents have been submitted, primarily for the EU countries, the USA, Japan and China. Based on the new treatment system, five new patent applications have been prepared and submitted to the patent authorities (Q1:99). A new patent application was filed in Sweden in the third quarter 2000. Production of Biolight® WCD and Biolight® DCD The production of Biolight® WCD (Wound Care Device) and Biolight® DCD (Dental Care Device) at Amersham Pharmacia Biotech AB in Umeå runs according to plan. The machines have passed the final tests at Semco and were approved according to MDD 93/42/EEC on June 28, 2000. Future Partners Discussions are under way with international companies regarding commercialization and distribution within the wound care sector. Result, cash flow and liquidity In 2000, sales amounted to SEK 0.5 M (0.9). The operating costs amounted to SEK 18.2 M (15.2). The Group's result after taxes showed a loss of SEK 19.7 M in 2000 (-13.6). The result was encumbered by costs of stock issue of SEK 3.0 M (-). The group's investments amounted to SEK 22.8 M during the year (0.7), including SEK 9.0 M for clinical trials and SEK 11.7 M for development of new treatment equipment. The investments of the parent company amounted to SEK 22.8 M (0.7). Liquid assets as of December 31, 2000, amounted to SEK 30.4 M (16.9). For the parent company, liquid assets as of December 31, 2000, amounted to SEK 30.3 M (16.8). The income statement, balance sheet, cash flow analysis, etc. presented below, refer to the group. Future reports Quarterly report for the 1st quarter, 2001 April 23, 2001 Semi-annual report 2001 August 21, 2001 Quarterly report for the 3rd quarter, 2001 November 1, 2001 Other information The annual general meeting for the financial year 2001, will be held on April 25, 2001, at 4 p.m. at Biolight International AB's headquarters in Danderyd. The annual report will be made available for the shareholders from April 9, 2001. It will also be published on the company's web site: www.biolight.se Danderyd, February 23, 2000 Board of Directors, Biolight International AB Biolight International AB is a medical technology company with products based on the biological effects of pulsating, monochromatic light. Biolight develops a system for effective, painless and safe treatment, primarily of chronic wounds and inflammatory conditions. The Biolight share is quoted on the SBI-list (SBI Marknadsplats AB). Income statement Amounts in SEK thousands 2000 1999 Operating income 526 936 Operating expenses Goods for resale -182 -139 Other external costs -10,435 -9,324 Personnel costs -6,008 -4,719 Depreciation of intangible and -1,539 -1,018 tangible assets Other operating expenses -11 -9 Operating loss -17,649 -14,273 Financial items 981 704 Issue expenses -2,997 - Loss before taxes -19,665 -13,569 Taxes 2 2 Net loss of the year -19,663 -13,567 Balance sheet Amounts in SEK thousands Dec. 31, Dec. 31, 2000 1999 Intangible assets 21,679 1,710 Tangible assets 2,094 781 Projects in progress 2,660 16,916 Other current assets 1,859 1,849 Liquid assets 30,456 16,935 Total assets 58,748 38,191 Shareholders' equity 55,723 35,337 Provisions 2 4 Current liabilities 3,023 2,850 Total shareholders' equity and 58,748 38,191 liabilities Cash flow analysis Amounts in SEK thousands 2000 1999 Current operations Loss after financial items -19,663 -13,569 Adjustments for items not included in 1,550 1,029 the cash flow -18,113 -12,540 Taxes paid - - Cash flow from current operations before changes of working capital -18,113 -12,540 Cash flow from changes of working 14,419 -8,193 capital Cash flow from current operations -3,694 -20,733 Investment activities Acquisitions of tangible and intangible -22,832 -669 assets Cash flow from investment activities -22,832 -669 Financing activities New issue 40,000 - Issue of debenture with detachable 49 212 subscription warrants Repayment of debts -2 -2 Cash flow from financing activities 40,047 210 Period's cash flow 13,521 -21,192 Liquid assets at beginning of year 16,935 38,127 Liquid assets at year-end 30,456 16,935 Key ratios No. of shares at year-end (thousands) 59,346 52,073 No. of outstanding subscription warrants 450 400 (thousands) Earnings per share -0.35 -0.26 Return on equity neg. neg. Return on capital employed neg. neg. Equity ratio in % 94.9% 92.6% Shareholders' equity per share, SEK 0.94 0.68 ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.bit.se/bitonline/2001/06/21/20010621BIT00660/bit0001.doc http://www.bit.se/bitonline/2001/06/21/20010621BIT00660/bit0001.pdf