Maintaining operational momentum
(Thomson Reuters ONE) - 14 August 2009, Lysaker, Norway: Pronova BioPharma ASA (OSE: PRON.OL)reports substantial growth in the second quarter with 43.9 per centrevenue growth and 46.4 per cent EBITDA growth year-on-year. Globalend-user sales in the first half year saw a strong increase of 39 percent to USD 490 million, driven by further strong growth in the USmarket. Based on excellent performance in the second quarter, globalsales reached blockbuster level in June, with an annual run-rate ofapproximately USD 1.2 billion (USD 735 million). Process validationwas successfully completed at the Kalundborg plant at the end ofJuly, and preparations for Good Manufacturing Practice (GMP)certification process have started.The progress in Pronova BioPharma's second quarter results was mainlydriven by continued strong production performance at the Sandefjordplant. Total production in the quarter amounted to 357 tonnes (315tonnes), following good in-house production and in-sourcing ofintermediate products. Shipments reached a record high volume of 395tonnes (315 tonnes), significantly higher than the 294 tonnes shippedin the first quarter. This was a result of the additional volumessent for capsulation in the first quarter and shipped in the secondquarter, as previously communicated.The group's gross margin in the second quarter was 72.3 per cent (79per cent) and continues to be impacted by in-sourcing ofintermediaries and higher cost of raw materials compared to the samequarter last year.EBITDA for the quarter increased by 46.4 per cent from the sameperiod last year, to NOK 221.1 million (NOK 151.1 million) andamounted to NOK 358.2 million for the first half year (NOK 272.7million). This equals an EBITDA margin of 48.6 per cent (47.8 percent) for the quarter and 47.3 per cent for the half year (47.4 percent). The EBITDA margin for the group's activities in Norway came to50.0 per cent for the quarter (51.7 per cent) and 49.1 per cent forthe first half year (50.6 per cent).The new plant in Kalundborg is now completed. At the end of July2009, the company had successfully produced three consecutive processvalidation (PV) batches, which concluded the important validation ofall production processes involved in manufacturing the activepharmaceutical ingredient (API). The plant is now preparing for GoodManufacturing Practices (GMP) certification, which is expected to beachieved late in the third quarter. The GMP certification will befollowed by EU regulatory filing early in the fourth quarter. US FDAfiling is expected late in the fourth quarter 2009. As previouslycommunicated, the first commercial volumes are expected to be shippedfrom Kalundborg in the first quarter of 2010 and the estimated totalinvestment of NOK 1 900 million remains unchanged.Underlying end-user sales maintained momentum in the second quarter,with global end user sales (June YTD) of USD 490 million (USD 353million). In the USA, Lovaza(TM) had 16.5 per cent share of all newprescriptions (NRx) in the non-statin dyslipidemic market (31 July2009), compared to 15 per cent at the beginning of 2009 (Source:IMS). The market share in total prescriptions (TRx) grew to 15.2 percent (31 July 2009) compared to 14 per cent at the beginning of theyear. Market dynamics in the non-statin dyslipidemic markets changedin 2009, with a new entrant on the markets. Lovaza(TM) has been ableto maintain the market-share in this competitive market, although thegrowth in market share has stabilised in the quarter. The non-statinmarket showed 9 per cent growth year-on-year (TRxs).Lovaza total prescriptions in the second quarter increased by 38 percent from the same period in 2008. Omacor® also continued its strongprogress in all European markets, where end-user sales amounted toUSD 148 million (June YTD) (USD 143 million) with an overall growthrate of 3.2 per cent from the same period last year. Thecorresponding volume growth in API sales of Omacor® was 21 per cent(Source: IMS)Following the three Paragraph IV notification letters received in thefirst quarter, Pronova BioPharma Norge AS filed lawsuits in Aprilagainst Teva Pharmaceuticals USA, Apotex Inc. and Par Pharmaceuticalin the United States District Court for the District of Delawareasserting infringement of Pronova BioPharma's US Patents Nos. 5 502077 and 5 656 667 relating to omega-3 acid ethyl ester compositionsand methods of using omega-3 acid ethyl esters. The SchedulingHearing took place on 11 August 2009. Pronova BioPharma has fullconfidence in the protection afforded by its intellectual propertyportfolio for Lovaza(TM) and will vigorously defend and enforce itspatents.Morten Jurs was appointed chief executive officer on 30 June tosucceed Per-Oluf Olsen. Mr Jurs, aged 49, has been chief financialofficer of Pronova BioPharma since 2006. He has comprehensiveexperience as CFO from Kitron ASA, Santech Micro Group ASA, TelenorNextra AS, and Broadband Mobile ASA. Mr Jurs has also been CEO ofIndustrial Communication Group ASA. Synne H Røine has been appointedchief financial officer. Ms Røine previously held the position as thegroup's finance director.The excellent production output from the Sandefjord plant, inaddition to the successful process validation of the Kalundborgplant, gives the group confidence in reaching its full yearproduction target of 1 550-1 600 tonnes. Continued in-sourcing fromthird parties will secure volumes to meet the strong end-user demand,and the strategic in-sourcing will continue in 2010.Commercial production will start in Kalundborg late in the thirdquarter. The produced volumes will be released for sale subject toregulatory approval in the respective markets during 2010. The groupexpects consequently to build a finished goods inventory level ofapproximately of 80-100 tonnes by year-end.Partner demand is still anticipated to exceed production volumes in2009, but this is expected to change as the Kalundborg plant comesfully on stream. Expected demand in 2010 is estimated to beapproximately 1 800 - 2 000 tonnes, depending on potential genericcompetition in the European market in 2010 and the developments inend-user sales.The solid performance in the first half of 2009 provides a excellentbasis for further progress.The complete second quarter and first half year report is availableat www.newsweb.no and at www.pronova.com.The company will present the results today at 08:30AM CET/07:30 GMT.The presentation, followed by a Q&A session, will be webcasted liveand can be accessed at www.pronova.com. (Internet explorer webbrowser needed). Web cast attendants may send questionselectronically during the session.-- Ends --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/1334768/317027.pdfhttp://hugin.info/137506/R/1334768/317028.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 14.08.2009 - 07:24 Uhr
Sprache: Deutsch
News-ID 4704
Anzahl Zeichen: 0
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 362 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Maintaining operational momentum"
steht unter der journalistisch-redaktionellen Verantwortung von
Pronova BioPharma ASA (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
