A strong financial and operational performance in 2009
(Thomson Reuters ONE) - 13 February 2010, Lysaker, Norway:Pronova BioPharma ASA (OSE: PRON.OL) deliveredstrong results in the fourth quarter and for the full year 2009, with a revenueincrease of 48.2 per cent and an EBITDA increase of 52.6 per cent year-on-year.Net profit amounted to NOK 86.4 million and was negatively impacted by currencytranslations related to inter company borrowings, but with no cash effect. Twosignificant milestones were passed in the quarter, as Omacor/Lovaza achievedannual end-user sales of more than USD 1 billion, reaching blockbuster statusand the Kalundborg facility was granted European regulatory approval. The newplant is already producing at 80 per cent of design capacity, which enabled thegroup to produce 504 tonnes in the quarter, adding up to 1 625 tonnes for theyear. High demand secured shipments of 440 tonnes in the quarter. The groupenters 2010 with a refocused growth strategy as it continues to drive sales andstrengthen its product offering.Total revenues in the quarter were NOK 538.1 million (NOK 363 million). Growthwas driven by increased production output and shipments. Total revenues for theyear increased to NOK 1 789.9 million (NOK 1 301.5 million)Gross margin was 76.3 per cent (75.7 per cent) in the quarter, positivelyimpacted by build-up of finished goods inventory following increased productionoutput from the Kalundborg plant. Gross margin for the year was 74.4 per cent(77.3 percent).EBITDA was at a record high and amounted to NOK 230.8 million (NOK 151.2million) in the quarter and NOK 823.4 million for the full year 2009 (NOK 603million). Profitability was maintained with an EBITDA margin of 42.9 per cent inthe quarter (41.7 per cent) and 46 per cent for the full year (46.3 per cent).Total operating profit for the quarter grew by 30 per cent to NOK 140.9 million(NOK 108.4 million). Operating profit for the full year 2009 grew by 33.1 percent and amounted to NOK 574.5 million compared to NOK 431.6 million for thefull year 2008.Net financial items for the quarter were negative at NOK 30.5 million (positiveNOK 102.4 million). Unrealised changes in the fair value of the inter-group loanbetween Pronova BioPharma Norge AS and Pronova BioPharma Danmark A/S had anegative effect on financial items of NOK 28.3 million. The NOK has strengthenedagainst the DKK since year end and the unrealised changes in fair value of theinter-group loan have negatively impacted financial items by NOK 214.6 millionfor the full year (positive impact of NOK 208.3 million).Net profit was negatively impacted by the above mentioned unrealised fair-valuechanges related to inter-group borrowings.The Kalundborg project concluded successfully with the achievement of Europeanregulatory approval in November 2009. With anticipated FDA approval as the solemajor remaining milestone, the group has executed slightly ahead of schedule.The plant has produced the first batches of commercial API, which have been sentfor capsulation and will be ready for shipment to the EU market in the firstquarter of 2010. Total production in the quarter came to 504 tonnes (309tonnes), which is an increase of 63.2 per cent from the same period last year. Atotal volume of 1 625 tonnes (1 201 tonnes) was produced during 2009, slightlyabove expectations. Total volume shipped was 440 tonnes (289 tonnes), anincrease of 52.2 per cent. 1 518 tonnes were shipped in the full year (1 185tonnes), an increase of 28.1 per cent.The ongoing litigation processes in the United States District Court for theDistrict of Delaware are progressing according to the agreed schedule and theparties have now entered the discovery phase. The nullity action against theItalian patent covering the group's API is in its final stage in the DistrictCourt of Milan and a ruling is expected during the first half.Preliminary clinical studies have been initiated with an alginate capsule tostudy the alginate characteristics in humans. Pending the outcome of thesepreliminary studies, the group will evaluate the design of further clinicaltrials needed for regulatory filings.The VITAL study is starting recruiting patients in Q1 2010. The study is one ofthe largest primary prevention trials, studying the effects of Omacor® andVitamin D in a population of20 000 trial subjects (men ? 60 years, women ?65years) with no history of cancer or cardiovascular disease (CVD).The R&D initiatives on several PRB candidates (next generation omega-3 derivedpharmaceuticals) are advancing successfully according to plan. Pending the finalpre-clinical documentation on the products, the group expects to advance intoclinical Phase I in late 2010.As part of the ongoing strategy to invest in newproducts, R&D expenses will increase as a consequence of clinical trials thatwill be initiated during the year.The 2010 costs related to the defence of intellectual property and patents areexpected to be slightly higher than the full year 2009, following the three USlitigation processes that are ongoing.2009 was a very successful year for the group, with strong financial andoperational performance. The company enters 2010 with a blockbuster product andincreased capacity in place and Pronova BioPharma is ready for a new strategicphase with an increased focus on driving the market potential of its products inexisting markets; new life-cycle developments to be executed; and launches ofOmacor/Lovaza in new territories to secure future revenue and profit growth.Weight will also be given to the development of new products as well otherinitiatives that will increase the robustness of the group.Pronova BioPharma is well positioned to realise further growth in revenues andprofit. A continued strong cash flow from operations is expected in theforeseeable future, and the major investment programme related to capacityincreases has been completed. This enables the company to pay dividend. Adividend will be paid in 2011 based on net profit achieved in 2010, and on thegroup's general financial position. The complete fourth quarter report is available at www.newsweb.no
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Datum: 12.02.2010 - 07:03 Uhr
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News-ID 12388
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