Lysaker, Tuesday, 12 February 2008: Pronova BioPharma ASA today announces its Q4 and full year 2007 results.
Q4 HIGHLIGHTS
· Revenues up 32.3 per cent to NOK 269.4 million (NOK 203.6 million), primarily driven by strong US growth.
· End user sales for Omacor/Lovaza increased significantly to USD 153 million, of which 57.5 per cent was in the US. The current run-rate is USD 662 million (Source: IMS).
· Excluding the expected non-recurrent employee IPO-bonus of NOK 15.9 million, EBITDA increased by 29.8 per cent to NOK 138.4 million. Reported EBITDA increased by 14.8 per cent to NOK 122.4 million (NOK 106.6 million).
· Excluding the expected NOK 15.9 million non-recurrent employee IPO-bonus, the EBITDA margin was 51.4 per cent. Reported EBITDA margin was 45.4 per cent (52.4 per cent) as a result of a number of non-recurring items.
· Pronova BioPharma’s distribution partner in the US, Reliant Pharmaceuticals Inc. (Reliant), was acquired by GlaxoSmithKline (GSK). GSK plans to more than double the US sales force for Lovaza to reach approximately 30 per cent more physicians.
· Construction of the new manufacturing plant in Kalundborg, Denmark, commenced in October and progress is in line with the Company’s execution plan. The Company anticipates the first commercial shipment of API from this plant by the end of the first quarter 2010.
· Production volume for the fourth quarter was 265 tonnes (208 tonnes), approximately 30 tonnes lower than expected due to quality issues with one batch of crude fish oil and an extended routine maintenance and upgrading operation. Shipped volume was 250 tonnes (167 tonnes).
· Despite the lower than expected production in the quarter, production efficiency has been excellent resulting in a gross margin of 82.3 per cent.
· In December, Pronova BioPharma entered into a worldwide licence and development agreement with FMC Corporation to develop products using a novel capsule technology.
· In November, the patent covering the API of Omacor was declared invalid in Germany. The potential volume that may be lost if generic competition occurs in the German market will be reallocated to other fast-growing markets. Pronova BioPharma is appealing the decision.
· The Company’s R&D programs have progressed well in the fourth quarter. The pre-clinical toxicology program for the lead candidate PRB-2 is complete and the analysis phase is ongoing. The GISSI-HF trial (congestive heart failure trial) has progressed well and is now in the final stages and both OM8Afib (atrial fibrillation trial) and OM9L (concomitant treatment of Omacor/Lovaza with atorvastatin) are also moving forward as planned.
FINANCIAL HIGHLIGHTS FOR THE YEAR
· Revenues: NOK 1 014.4 million (NOK 669.4 million) – up 51.5 per cent
· EBITDA: NOK 503.3 million (NOK 271.4 million)
§ Excluding IPO-bonus: NOK 519.3 million – up 91.3 per cent
· EBITDA margin: 49.6 per cent (40.5 per cent)
§ Excluding IPO-bonus: 51.2 per cent
Tomas Settevik, Chief Executive Officer of Pronova BioPharma, today commented:
“GSK will more than double the US sales force to around 1 500 sales representatives, which will enable access to at least 30 per cent more physicians. We believe the change in ownership will be very beneficial for sales of Lovaza in the US and thus our future prospects.”
For further information, please contact:
Tomas Settevik, CEO +47 22 53 48 61
Morten Jurs, CFO +47 99 16 79 22
Hilde Steineger, Head of IR +47 48 00 42 40
Deborah Scott, Financial Dynamics +44 207 269 7110
About Pronova BioPharma
Pronova BioPharma (previously Pronova Biocare) 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 Lovaza in the United States. The product is manufactured at the Company’s plant in Sandefjord, Norway using a unique and complex process.
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 (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 over 1,750 sales representatives, of which approximately 600 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 USD 144 million in 2005 to USD 306 million in 2006. The current annual run rate for end-user sales is estimated at USD 500 million, and the Company estimates that approximately 600,000 patients are currently on a prescription for Omacor/Lovaza.
