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Pronova BioPharma ASA (OSL:PRON) Pronova BioPharma posted strong third quarter results, driven by robust end-user demand and consistent performance at the Sandefjord plant. In-sourcing of intermediaries has facilitated the increase of the production forecast for 2009 to 1 400-1 500 tonnes. Positive results for the GISSI-heart failure trial were published at the European Society of Cardiology in August. Both primary endpoints were met.
Shipments increased substantially in the third quarter and translated into revenues of NOK 363.3 million (NOK 257.6 million), an increase of 41 per cent quarter on quarter. The total volume shipped was 342 tonnes (246 tonnes). EBITDA was up 30.6 per cent to NOK 179.1 million (NOK 137.2 million), reflecting higher shipped volumes and higher operating costs. The EBITDA margin was 49.3 per cent (53.2 per cent), impacted by increased operating expenses at the Kalundborg plant and increased in-sourcing of intermediaries.
Positive results from the 7 000 patient Phase III GISSI-heart failure trial were published in August, demonstrating that Omacor reduced mortality and morbidity in patients with congestive heart failure (CHF). Both primary endpoints were met. In the study, which was published in The Lancet, the authors observed that the advantage of Omacor documented for both primary endpoints suggested that it has a positive effect on the mechanisms leading to the progression of heart failure.
Construction of the new manufacturing plant in Kalundborg is progressing as planned, with all main equipment delivered and installed. The group remains on track to deliver the first commercial shipment of Pronova BioPharma's API from this plant in the first quarter of 2010.
Omacor/Lovaza is growing at a rapid pace in all markets, and the company expects this positive trend to continue. The global end-user sales of Omacor/Lovaza grew by 56 per cent to USD 482.1 million year to date (31 August), with an estimated annual run-rate* of USD 741 million (31 August 2007: USD 476 million). Strong growth was also seen in USA end-user sales, up 63 per cent to USD 281.7 million year to date (31 August), with an annual run rate* of USD 479 million. The strong promotion by marketing partner GSK in the USA continued and made Omacor/Lovaza one of GSK's fastest-growing products in the quarter. (* Source IMS)
Production volume increased to 321 tonnes (262 tonnes). Based on increased in-sourcing of intermediaries and optimised production processes, it is expected that the 2008 production target of 1 200 tonnes will be exceeded.
In-sourcing of intermediaries will continue as part of an ongoing strategic planning process to meet the strong end-user demand in the remaining part of 2008 and 2009. A sourcing agreement with an undisclosed third party manufacturer has been entered into for the supply of high quality intermediaries for the manufacture of Pronova BioPharma's Active Pharmaceutical Ingredients (APIs). As a result, the group has increased its 2009 production forecast to 1 400-1 500 tonnes. The increased volumes are expected to be realised in the second half of 2009.
The complete third quarter report is available at www.newsweb.no and at www.pronova.com.
A presentation and webcast of the results will be held at today at 08:30AM CET/07:30 GMT. The webcast can be accessed at www.pronova.com. In addition, the company will host a telephone conference which will open for Q&A immediately after the presentation.
Please dial the following numbers: (Participants are asked to connect 5 minutes before the conference) International toll number UK + 44 (0)207 750 99 50 International toll number SE + 46 (0) 8 506 269 30 International Toll Number NO +47 21 51 11 81 The following dial-in code is required for Norway: 878175# No dial-in code is required for UK and SE toll numbers. -- Ends --
For further information, please contact: Hilde H. Steineger, Head of IR +47 48 00 42 40 Morten Jurs, CFO +47 22 53 49 10 About Pronova BioPharma Pronova BioPharma is a global leader in the research, development and manufacture of marine-originated omega-3 derived pharmaceutical products. Pronova BioPharma's first commercialized product is branded as Omacor® in a number of countries throughout Europe and Asia and as LovazaTM in the USA. The product is manufactured at the company's plant in Sandefjord, Norway using a unique and complex process. An additional manufacturing plant is under construction in Kalundborg, Denmark and is expected to be operational in the first quarter of 2010. Omacor/Lovaza is the first and only EU- and FDA-approved omega-3 derived prescription drug. The drug is prescribed as an adjunct to diet for the treatment of elevated levels of triglycerides in humans, a condition known as hypertriglyceridemia (HTG), a form of dyslipidemia (or disorder of lipid metabolism). Very high triglycerides have been linked to a number of cardiovascular diseases. Omacor is also approved in key European and certain Asian markets for the secondary prevention of post-myocardial infarction, or Post-MI, the period following the initial survival of a heart attack. Omacor/Lovaza has been demonstrated in a number of clinical trials to be a potent triglyceride-lowering agent as a monotherapy. It has been documented to be efficacious, safe, and highly complementary to other lipid-lowering agents, such as statins, and can be used in concomitant treatment for mixed dyslipidemia. In addition, Pronova BioPharma is involved in various projects to develop Omacor/Lovaza in a number of cardiovascular indications, including as a combination therapy with statins for mixed dyslipidemia which management believe represents a major market opportunity for the group. Pronova BioPharma's global network of license and distribution partners includes: Reliant Pharmaceuticals (owned by GlaxoSmithKline PLC) (US), Takeda Pharmaceutical (Japan), Prospa (Italy) and Solvay (UK, Germany and others). The combined sales force from this network focused on the sale of Omacor/Lovaza is approximately 2 650 sales representatives, of which about 1 500 are employed by Reliant Pharmaceuticals in the US. Omacor/Lovaza was launched in 2005 in the US and in major European markets, such as France and Spain. IMS Health reports that global end-user sales of the product have increased from US$144 million in 2005 to US$306 million in 2006 and US$511 million in 2007. The current annual run rate for end-user sales is estimated at US$735 million (as of May 2008), and the company estimates that approximately 750 000 patients are currently on a prescription for Omacor/Lovaza. Pronova BioPharma had revenues of NOK 1 014 million and EBITDA of NOK 503 million in 2007. The company is listed at Oslo Børs. See www.pronova.com for more information.
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