Well positioned to realise long term growth potential with doubled
production capacity
(Thomson Reuters ONE) - 3 November 2009, Lysaker, Norway: Pronova BioPharma ASA (OSE:PRON.OL) reached a significant milestone in the third quarter, withthe achievement of Good Manufacturing Practice (GMP) certificationfor the new plant in Kalundborg, Denmark. EU regulatory approval isexpected in the first quarter of 2010. The new plant will enablePronova BioPharma to meet the strong increase in product demand,driven by a continued growth of end-user sales. The company shipped389 tonnes in the third quarter, with revenues up 20.5 per cent andEBITDA up 15.8 per cent year-over-year. The major capital expenditureon the Kalundborg project is winding down. The group's net cash flowfrom operating activities was NOK 164.8 million in the quarter, andthe group has now completed the major part of capital expenditure onthe Kalundborg plant.Total revenues in the quarter increased to NOK 437.9 million (NOK363.3 million), driven by increased production output and shipments.Sales in USD were recorded at an average exchange rate of NOK 6.07per USD (NOK 5.70).Gross margin was 74.4 per cent (75.7 per cent) for the quarter and73.6 per cent (77.9 percent) YTD. The gross margin for the quarterwas negatively impacted by the planned in-sourcing of intermediariesand by the increased cost of materials. This increase in cost wassomewhat offset by increase in inventory of work in progressfollowing the start of production in Kalundborg.Following the growth in revenues, EBITDA for the third quarterincreased by 15.8 per cent in the quarter and amounted to NOK 207.5million (NOK 179.1 million) and NOK 592.6 million for the first ninemonths (NOK 451.8 million), representing an EBITDA margin of 47.4 percent in the quarter (49.3 per cent) and 47.3 per cent YTD (48.1 percent).The group's operating profit for the quarter was in line with thesame period last year. The increase was offset by increaseddepreciation in Denmark. Operating profit for the quarter amounted toNOK 135.4 million (NOK 136.3 million). The operating profit for thefirst nine months of 2009 increased by 34.2 per cent and amounted toNOK 433.6 million compared to NOK 323.1 million for the same periodin 2008. The growth in operating profit in thefirst nine months is a result of the growth in revenues and grossprofit.The capacity investment programme is now close to completed. TheKalundborg plant was GMP certified during the quarter, and withdoubled capacity available, Pronova BioPharma will be able to meetthe strong increase in demand, driven by continued growth in end-usersales. Pending regulatory approval from EU authorities, the group iswell on track for the first commercial shipment from the plant in thefirst quarter of 2010.A volume of 396 tonnes was produced in the quarter (321 tonnes), up23.2 per cent year-over-year. The total volume shipped was 389 tonnes(342 tonnes), an increase of 13.8 per cent.A letter of intent was signed in September for the VITAL study.Pending a final agreement, Pronova BioPharma will supply the trialwith Omacor as study drug. The study is one of the largest primaryprevention trials, studying the effect of Omega-3 FA / Vitamin D, ina population of 20 000 trial subjects (men >= 60 years, women >= 65years) with no history of cancer or cardiovascular disease (CVD).The ongoing litigation processes in the United States District Courtfor the District of Delaware are progressing according to the agreedschedule and the parties are preparing for the discovery phase. Thescheduled trial date is set to 28 March 2011.IBSA's application for marketing authorisation of a generic versionof Seacor in Italy has been rejected by the Italian PharmaceuticalAgency (AIFA). IBSA has appealed AIFA's decision. In the nullityaction against the Italian patent covering the company's API, ahearing was held 28 October 2009 in the District Court of Milan andthe judge set the deadlines in early 2010 for the submission of theparties' final briefs and final replies. No generic entrants havebeen observed in the quarter post patent expiry in any of theEuropean countries.The Italian GISSI group is finalising the study report from theGISSI-HF study, including several sub-group analysis. One of thesubgroup analysis that was presented at the ESC 2009 in Barcelonashowed encouraging results where Omacor/ Seacor significantly reduceddeath or hospitalization for ventricular arrhythmias. The group willevaluate the full set of results from the GISSI-HF study and isexpected to conclude in Q1 2010 on the further utilisation of theclinical data.The group's R&D initiatives on several PRB candidates (nextgeneration omega-3 derived pharmaceuticals) have increased during thequarter, preparing to advance into clinical Phase I during 2010. Thefixed-dose combination product, consisting of 1 g of PronovaBioPharma's API and 20 mg simvastatin, has been tested inbioequivalence studies with encouraging results. The group's partnerSigma Tau (Defiante) has consulted regulatory agencies in Europe withpositive feedback on the planned regulatory approach and expectedlaunch of the product is in 2010/2011.Some of the agreements between Pronova BioPharma and its licensingpartners have price adjustment elements that are partly linked to thecrude fish oil price, which has been subject to extraordinaryfluctuations. As a consequence, 2010 sales price to some partnerswill be negatively impacted. The revenues per shipped volume (NOKmillion per tonne shipped) in 2010 is expected to be in the range0.95-1.0. The negative impact will partly be offset by reducedmaterial costs.With the completion of the new plant in Kalundborg, the group is wellpositioned to meet the increasingly strong growth in end-user demand.The additional capacity available from the beginning of 2010 enablesPronova BioPharma to further strengthen its focus on increasingmarket potential for its lead product, such as continued growth inexisting markets, successful launches in new markets, and thedevelopment of new indications, new formulations and new products.The increase in production, supported by the in-sourcing ofintermediate products, gives the group confidence that the full yearproduction target for 2009 of 1 550-1 600 tonnes will be met. Withcommercial production starting in Kalundborg late in the thirdquarter and the first commercial shipments expected in Q1 2010, thegroup expects to build a finished goods inventory level ofapproximately 80-100 tonnes by the end of 2009. Expected demandin 2010 is estimated to be approximately 1 800 -2 000 tonnes,depending on potential generic competition in the European market in2010 and the developments in end-user sales.The complete third quarter report is available at www.newsweb.no andat www.pronova.com.The company will present the results today at 08:30AM CET/07:30 GMT.The presentation, will be webcasted live and can be accessed atwww.pronova.com. (Internet explorer web browser needed). Web castattendants may send questions electronically during the session.For further information, please contact:Hilde H. Steineger, Vice president IR and communications +47 48 00 4240Synne Røine, CFO +47 22 53 49 10http://hugin.info/137506/R/1352123/327015.pdfhttp://hugin.info/137506/R/1352123/327016.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 03.11.2009 - 07:00 Uhr
Sprache: Deutsch
News-ID 7798
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