Quarterly report January 1 - March 31, 2001

Biolight International AB (publ) Quarterly report January 1 - March 31, 2001 · The wound healing study finalised during the first quarter is a decisive breakthrough for Biolight®. The established effect is considerable and statistically significant. · Biolight® PCD (Physiotherapeutic Care Device) - a new device for the treatment and rehabilitation of sports injuries - was approved for CE-marking in March, 2001. · The company filed a 510(k) application with the FDA in February 2001 for the area dental care. FDA desires to study the clinical documentation. · In January, a Technical Director, whose responsibilities include production, logistics and quality, was employed. · In January, the Company was granted another two patents in the USA. Company focus in 2001 In 2001, the Company will focus its resources on implementing a commercialisation within its core areas - Biolight® Wound Care, Biolight® Dental Care and Biolight® Physiotherapeutic Care. Scientific results and research programs BL-030 and BL-034, Decubitus ulcers The analysis of data from two randomised, double-blind and placebo- controlled phase III studies on the effect of treatment with Biolight® on the healing of decubitus ulcers, grade 2, is finalised. Regarding effect, the results show a statistically significant difference of 61 % 1) (p=0.0394) between patients treated with Biolight® compared to placebo-treated patients. The study has been carried out at 9 centres in Sweden and Denmark. The healing of the wounds has the same pattern and speed as in the earlier studies. The results show that the time to healing after treatment with Biolight® was reduced by 36%. 163 patients (79 Biolight®, 84 placebo) are included in the analysis. Ove Dehlin, professor of geriatrics in Malmö, Sweden, Sölve Elmståhl, professor of geriatrics, Malmö, Sweden, and Finn Gottrup, professor of wound healing in Copenhagen, Denmark, who have jointly headed the execution of the clinical phase III studies on decubitus ulcers, make the following statement: "Decubitus ulcers is a big problem in medical care, and primarily affect older patients, who already suffer from other complicated illnesses. In recent years, there hasn't been anything principally new in the treatment of decubitus ulcers, until now. Biolight® is pulsating, monochromatic light, which in pre-human studies has shown interesting biological effects in relation to wound healing. In two double-blind, placebo-controlled studies, we have examined the effects of Biolight® on decubitus ulcers, grade 2, in older patients. In the first study, promising but not altogether significant results (p=0.06) were achieved, which is the reason why that study has now been complemented with another one, and these studies have been pooled. The results are satisfactory. Treatment with Biolight® made the wounds heal significantly faster compared to placebo (p=0.04). No serious side effects have been observed." Professor Jan-Åke Gustafsson of the Department of Medical Nutrition and the Department of Biosciences, Novum, the Karolinska Institute, and chairman of Biolight's scientific council, says: "The healing effect of Biolight® in the treatment of decubitus ulcers, is now clearly established through the same stringent criteria as apply to the trial of drugs. Thus, Biolight has taken a definite step from being an alternative medical method into being an allopathic treatment method." BL-032, Gingivitis A scientific article is under way concerning the study which was carried out and presented during the second quarter, 2000. The study was a double-blind, randomised, placebo-controlled phase III study on patients with gingivitis (inflammation of the gums). 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®, in comparison to 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. Biolight® Physiotherapeutic Care The German sports centres which have been trying Biolight® for the rehabilitation of acute sports injuries since February 2000, have reported very good treatment results, which has induced the Company to examine the possibilities for distribution in Germany. Biolight® PCD (Physiotherapeutic Care Device) - a new device for the treatment and rehabilitation of sports injuries - was approved for CE- marking in March. Biolight® Dental Care In January, the Company started a market test for Biolight® with dentists and dental hygienists in Sweden. The goal of this test is to get indications regarding acceptance, price intervals for the treatment, and the actual handling of the equipment. The results of the test will form the basis of a marketing effort for the indication Gingivitis, which is expected to begin in the third quarter, 2001. The company filed a 510(k) application with the FDA in February 2001 for the 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. The FDA desires to study the clinical documentation before starting its assessment. The time available for an assessment at the FDA is 90 days. All clinical documents have been sent to FDA. Biolight® Wound Care Discussions are ongoing with international companies regarding commercialisation and distribution within the wound care sector. Patents The Company was granted another two patents in the USA in January 2001. In 2000, the patent protection was reinforced through four new patents, two of them in China and two in Canada. The company now has a total of four patents in Sweden, four in the USA, two in Canada and two in China. 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. 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. Result, cash flow and liquidity Sales during the first quarter amounted to SEK 114 T (182). Operating expenses during the first quarter amounted to SEK -6,374 T (-3,250). The result of the period amounted to a loss of SEK -5,976 T (-2,967). Investments during the first quarter amounted to SEK 512 T (223). Liquid assets as of March 31, 2001, amounted to SEK 24,693 T (11,648). As of December 31, 2000, liquid assets amounted to SEK 30,456 T. This quarterly report has not been subjected to audit by the company's auditors. Future reports Semi-annual report 2001 August 23, 2001 Quarterly report for the 3rd quarter, 2001 November 1, 2001 Danderyd, April 23, 2001 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 listed on the NGM Equity (Nordic Growth Market NGM AB). Income statement Group Jan. - March Whole year Amounts in SEK thousands 2001 2000 2000 Operating income 114 182 526 Operating expenses Goods for resale -31 -49 -182 Other external costs -3,328 -1,593 -10,435 Personnel costs -1,754 -1,388 -6,008 Depreciation of assets -1,257 -220 -1,539 Other operating expenses -4 - -11 Operating loss -6,260 -3,068 -17,649 Financial items 284 101 981 Issue expenses - - -2,997 Loss before taxes -5,976 -2,967 -19,665 Taxes - - 2 Net loss of the period -5,976 -2,967 -19,663 Balance sheet Amounts in SEK thousands March March Dec.31, 31, 2001 31, 2000 2000 Intangible assets 20,583 1,686 21,679 Tangible assets 2,445 808 2,094 Projects in progress 3,530 18,743 2,660 Other current assets 1,527 1,027 1,859 Liquid assets 24,693 11,648 30,456 Total assets 52,778 33,912 58,748 Shareholders' equity 49,746 32,370 55,723 Provisions 2 4 2 Current liabilities 3,030 1,538 3,023 Total shareholders' equity and 52,778 33,912 58,748 liabilities Cash flow analysis Group Jan. - March Whole year 2001 2000 2000 Current operations Loss after financial items -5,976 -2,967 -19,663 Adjustments for items not included in 1,257 220 1,550 the cash flow -4,719 -2,747 -18,113 Taxes paid - - - Cash flow from current operations before changes of working capital -4,719 -2,747 -18,113 Cash flow from changes in working -532 -2,317 14,419 capital Cash flow from current operations -5,251 -5,064 -3,694 Investment activities Acquisitions of tangible and -512 -223 -22,832 intangible assets Cash flow from investment activities -512 -223 -22,832 Financing activities New issue - - 40,000 Issue of debenture with detachable - - 49 subscription warrants Repayment of debts - - -2 Cash flow from financing activities 0 0 40,047 Period's cash flow -5,763 -5,287 13,521 Liquid assets at beginning of year 30,456 16,935 16,935 Liquid assets at end of period 24,693 11,648 30,456 Key ratios No. of shares at end of period 59,346 52,073 59,346 (thousands) No. of outstanding subscription 450 400 450 warrants (thousands) Earnings per share -0.10 -0.06 -0.35 Return on equity neg. neg. neg. Return on capital employed neg. neg. neg. Equity ratio in % 94.3% 95.5% 94.9% Shareholders' equity per share, SEK 0.84 0.62 0.94 The effect is expressed as the difference in reduction of normalised wound area between the groups in the 12th week. ------------------------------------------------------------ This information was brought to you by Waymaker http://www.waymaker.net The following files are available for download: http://www.bit.se/bitonline/2001/06/21/20010621BIT00650/bit0002.doc http://www.bit.se/bitonline/2001/06/21/20010621BIT00650/bit0002.pdf