Irish drug company Amarin says sales from its one cardiovascular drug for 2019 will be at or above the upper end of its previous guidance – indicating growth of at least 85 per cent on the previous year.
Amarin has developed a highly purified fish oil drug, Vascepa, which has been shown to reduce the risk of heart attacks and strokes in patients who are already being treated with statins for high cholesterol but who still show heightened levels of harmful blood fats called triglycerides.
The drug has been marketed to a relatively small group of patients with extremely high levels of these blood fats for several years but, in December, the US regulator – the Food and Drug Administration – approved its use for a far wider group of patients.
Amarin has since secured permission to market the drug in Canada and has applications lodged with regulators in Europe, Asia and north Africa.
"Early feedback from physicians and medical societies has been positive regarding the new indication for Vascepa," said chief executive John Thero. " Our aim is to make Vascepa a new standard of care for the benefit of millions of patients."
Free of debt
The company said 2019 sales would come also totally from the US market and it would end the year with $645 million (€579 million) in cash. At year end, it said, it was free of debt apart from $55 million in royalty payments, which will likely be paid in full before the end of 2020.
The company also said it was doubling its US sales force to 800 as it looks to reach 75,000 doctors across the US. It also hopes to get FDA approval later this year for direct-to-consumer promotion of Vascepa.
While Amarin is projecting sales growth of up to 65 per cent next year to between €650 million and $700 million, it said it did not expect to see an immediate spike in sales following the wider FDA approval as target patients for the medicine generally see their doctors only infrequently.
Beyond 2020, Amarin believes that Vascepa total net revenue will grow to reach multiple billions of dollars
Amarin has now raised its 2019 guidance three times. At the start of last year, Amarin was pencilling in sales of about $350 million for the year, up more than 50 per cent on 2018. In July, that guidance was updated to between $380 million and $420 million and last month, after the FDA approved its wider use in patients at risk of heart attack or stroke, the company raised the guidance again – to between $410 million and $425 million.
Even higher
It now says full-year 2019 sales could be even higher.
“Beyond 2020, Amarin reiterates that it believes that Vascepa total net revenue will grow to reach multiple billions of dollars,” the company said in a statement.
It said that it would double its spending on inventory this year to $250 million to ensure it has sufficient supplies in place as it acknowledges that it is struggling to predict the rate of growth in sales.
Operating expenses are also expected to rise by up to $250 million as the company ramps up its sales team and the promotion of Vascepa.
