13 February, 2009, Lysaker, Norway: Pronova BioPharma ASA (OSE: PRON.OL) (“Pronova BioPharma” or the “company” or the “group”) announces fourth quarter and full year 2008 results.
Q4 2008 – Operating highlights
(Figures in brackets = Q4 2007 unless other specified)
• 309 tonnes produced (265 tonnes) and 289 tonnes shipped (250 tonnes) in the quarter. The full year production volume of 1 200 tonnes was reached
• Mechanical completion achieved in Kalundborg in January 2009 – testing of installed equipment is ongoing and production of intermediate products is expected to start by the end of the first half of 2009
• Key results from the OM9L study published, demonstrating a significant reduction in non-HDL-C levels and improvement in secondary endpoints with atorvastatin 10 mg/d in combination with Omacor®/Lovaza™
• Strong growth in global end-user sales for Omacor/Lovaza, up 52 per cent to USD 778 million for the full year 2008. Estimated annual run-rate is USD 953 million* (31 December 2007: USD 662 million)
• Continued strong sales and marketing support in the major European markets securing a 34 per cent growth for the full year, to USD 289 million
• New CEO with extensive experience from the pharmaceutical industry appointed. Per–Oluf Olsen took up the position on 17 November 2008
• Annual production capacity for 2009 estimated to approximately 1 500 tonnes through in-sourcing of intermediate products
Q4 2008 – Financial highlights
(Figures in brackets = Q4 2007 unless other specified)
• Revenues up 34.8 per cent to NOK 363 million (NOK 269.4 million); underlying revenues (at constant currency) up 24.4 per cent
• EBITDA up 23.9 per cent to NOK 151.2 million (NOK 122.1 million), reflecting higher shipped volumes and higher operating costs
• EBITDA margin at 41.7 per cent (45.3 per cent), impacted by increased operating and one-off expenses of some NOK 14.6 million related to change of CEO and remuneration to Omacor inventors
• Gross margin at 75.7 per cent (82.3 per cent) cent influenced by increase use of in-sourced intermediate products in the quarter
• Cash flow from operating activities was NOK 206.9 million (NOK 88.9 million
Full year 2008 financial highlights (Figures in brackets = FY 2007)
• Revenue growth of 28.3 per cent to NOK 1 301.5 million (NOK 1 014.4 million)
• EBITDA1 increased to NOK 603 million (NOK 503 million)
• EBITDA margin2 of 46.3 per cent (49.6 per cent)
• EBITDA margin for Pronova BioPharma Norge AS was 50 per cent
• Gross margin of 77.3 per cent (80.1 per cent)
Commenting on the fourth quarter and full year results, Tomas Settevik, president and CEO of Pronova BioPharma said:
"This has been a period of outstanding achievement for Pronova BioPharma, with continued strong global demand for our products helping to drive a 35 per cent rise in group revenues in the fourth quarter. Sales of Omacor/Lovaza were up by 52 percent in the fourth quarter. We made significant progress in our efforts to meet this demand through an excellent performance at our Sandefjord plant and in-sourcing of intermediaries from trusted third party suppliers. With the acceleration of our new plant at Kalundborg, which is on track to produce intermediaries by the end of June 2009, full year API production is expected to total approximately 1500 tonnes this year. Clinical endorsement of the positive impact of Omacor/Lovaza on cardiovascular health, including the GISSI-HF and OM9L studies, has ensured that sales are growing at a rapid pace in all markets and the positive trend is expected to continue.”
1) EBITDA is defined as profit for the accounting period before financial income and financial expense, income tax expense and depreciation and amortization.
Pronova BioPharma presents EBITDA because it is considered to be an important supplemental measure of the group’s operating performance and
believe it is frequently used by securities analysts, investors and other interested parties in the evaluation of companies in the industry
2) EBITDA margin is defined as EBITDA for a particular period divided by revenues
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 first quarter 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 Company.
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$650 million, 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.
Certain statements in this release concerning our future growth prospects are “forward-looking statements”, which involve a number of risks, and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding fluctuations in earnings, our ability to manage growth, intense competition in the pharmaceutical industry including those factors which may affect our ability to manufacture our products, our ability to attract and retain highly skilled professionals, the regulatory environment in which we operate and unauthorized use of our intellectual property and general economic conditions affecting our industry. We do not undertake to update any forward-looking statement that may be made from time to time by us or on our behalf.
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