Pronova BioPharma ASA: Expanding the Pharmaceutical Business into Clinical Nutrition

14 February 2012, Lysaker, Norway: Pronova BioPharma today announced results for the fourth quar­ter and full year 2011. Fourth quarter revenues were NOK 444.3 million, up 14 percent from a year before, and revenues for the year ended 31 December 2011 were NOK 1 668.9 million, up 2 percent from last year. EBITDA was NOK 197.1 million in the fourth quarter, up 53 percent year-on-year, and was NOK 705.3 million for the full year, up 13 percent from last year.

End-user demand in Pronova BioPharma`s current eight largest markets, as measured by IMS, grew by 5 percent in 2011, represent­ing total volumes of 1 273 tonnes. This represents USD 1.4 billion in drug sales, with Omacor®/Lovaza(TM) maintaining its status as a blockbuster product. During the year, GSK reached its expected inventory target for 2011. The reduction in demand was partially offset by higher off-take from other partners in Europe and Asia. Omacor®/Lovaza(TM) is currently sold in 57 markets, and the Group continues to expand its geographic reach.

The Board of Directors propose to adjust the existing dividend pol­icy to between 40 and 60 percent of net profit adjusted for pre-tax amortisation costs. The decision reflects the continued strong cash generation of Pronova BioPharma and the Company`s commitment to provide competitive returns to investors. The Company believes that adjusting for non cash amortisation costs better emphasises the strong cash conversion in the dividend policy. Furthermore, a more narrow range of 40 to 60 percent of adjusted net profit allows Pronova BioPharma to give a more targeted guidance to the financial community going forward. The Company will continue to evaluate annual dividends against the objectives of maintaining a solid financial position and investments to grow the business.

In line with the revised dividend policy, the Board of Directors pro­pose a first dividend of NOK 0.5 per share for 2011, corresponding to approximately 50 percent of net profit adjusted for pre-tax amortisation cost. This reflects the significant progress made towards the Company`s strategic objectives in 2011, which has strengthened the Company`s financial position and diversified its future cash generation capabilities.

Based on current market conditions, Pronova BioPharma main­tains its outlook for 2012, with shipments in line with underlying end-user demand and launches in new markets. Supply prices, as measured by the revenue-to-shipment ratio are expected to be in line with 2011 levels. The Company expects, all other things being equal, revenue and EBITDA growth in 2012.

However, as previously communicated, there is a risk of loss of exclusivity in Europe, where patents in most countries expired 30 months ago. There is also a risk of generic launch in the USA if the US District Court for the District of Delaware (District Court) rules against Pronova BioPharma in the litigation against Teva and Par, the US Food and Drug Administration (FDA) grants approval to the generic companies and API supply is available in sufficient volume. The Company expects a ruling within the next three months.

The Group today announced plans to expand its pharmaceuti­cal business into clinical nutrition. Clinical nutrition is nutrition taken under medical supervision and is provided in either enteral or parenteral form. The omega-3 market for clinical nutrition is estimated at 500 tonnes in 2011 and is expected to double in size within five years.

Pronova BioPharma plans to develop new clinical nutrition prod­ucts in collaboration with leading scientists and commercial partners. Products will be differentiated from existing offerings through such factors as concentration and purity levels, quality assurance, and health claims/scientific documentation.

Pronova BioPharma also continues to make progress in its research efforts to develop new drugs in the metabolic/cardiovascular/inflammatory treatment areas. The Group`s lead pipeline candidate PRC-4016, a new chemical entity for the treatment of combined dyslipidemia (abnormal blood lipid levels), is currently in Phase I trials. Dyslipidemia has been shown to play an important role in the development of cardiovascular risk. PRC-4016 is a structurally modified omega-3 fatty acid, which has shown in pre-clinical studies to have potent triglyceride and bad (non-HDL) cholesterol lowering effects while raising good (HDL) cholesterol. The trial is a double-blind, placebo-controlled, single and multiple oral dose study to investigate the safety, tolerability and pharmacokinetics of PRC-4016. The study, conducted in healthy volunteers, is being performed in the UK. The trial is progressing well and top line results are expected to be announced in Q2 2012.

In November 2011, Pronova BioPharma announced that it will develop a consumer healthcare business, entering the fast-growing Omega-3 consumer healthcare market. The business will initially target the high concentrate dietary supplement market, which is expected to double in size in the next five years. Since the announcement, Pronova BioPharma has made substantial pro­gress in developing this business. The manufacturing facility in Sandefjord, Norway has been selected to serve the consumer healthcare business and the necessary modifications are being implemented. The Company has also strengthened the manage­ment team with the appointment of Claus Kjærsgaard as VP of Consumer Healthcare and a number of experienced professionals are in the process of being hired for the new division. Claus brings 15 years of consumer healthcare experience across a diversity of categories, distribution channels and geographical environments.

Pronova BioPharma continues to extend its manufacturing advan­tages. In June 2011, the Group announced a target of increasing yield by 50 percent by the end of 2014 compared to 2009 levels. Pronova BioPharma is well on its way to achieving that target.

Pronova BioPharma`s Chief Executive Officer Morten Jurs com­mented, "In 2011, we continued to generate strong cash flow and made significant progress towards our strategic objectives. Our core pharmaceutical business continued to grow, and we launched our product in new markets. On the manufacturing side, we improved yield to further strengthen our competitive advantage in manufacturing versus potential market entrants. With our progress in R&D, expansion into clinical nutrition and our plans to launch a consumer healthcare business, we have made Pronova BioPharma a more diversified company and created new sources of growth. "

This information is subject of the disclosure requirements acc. to §5-12 vphl (Norwegian Securities Trading Act)Report Q4 11
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Source: Pronova BioPharma ASA via Thomson Reuters ONE
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