With gross sales of its flagship cardiovascular drug flagging, Amarin is implementing a companywide restructuring that considers the truth of the generic competitors consuming away at its income.
The company shakeup will shave headcount by 30%, leading to about $40 million in annual financial savings. On the finish of 2022, Amarin reported a headcount of 365 full-time staff in 15 international locations. The corporate is pursuing its new course underneath new management. Quickly after the restructuring announcement late Tuesday, Amarin introduced the appointment of Patrick Holt as president and CEO efficient instantly. He additionally joins the corporate’s board of administrators. Holt was most lately president of Cordis, a cardiovascular medical system subsidiary of Cardinal Well being.
Amarin, which is predicated in Dublin however maintains most of its operations in Bridgewater, New Jersey, has one commercialized product: Vascepa. The twice-daily capsule was first authorized by the FDA in 2012 for sufferers with hypertriglyceridemia, a situation characterised by elevated triglycerides, a kind of fats within the blood that in excessive quantities will increase the chance of coronary heart illness and stroke. In 2019, the drug was authorized for lowering the chance of cardiovascular problems extra broadly in sufferers who’ve elevated triglyceride ranges. The Amarin product acquired regulatory approvals in Europe in 2021, the place it’s marketed underneath the title Vazkepa.
Vascepa’s major ingredient is an omega-3 fatty acid that comes from fish oil. In 2020, a federal courtroom struck down Amarin’s patent on its product. The corporate appealed, however the U.S. Supreme Courtroom in 2021 declined to take the case.
The lack of patent safety opened the door to generic variations of Vascepa from corporations corresponding to Dr. Reddy’s Laboratories, Hikma, Teva Prescription drugs, and Apotex. Consequently, Vascepa’s gross sales have plunged. In 2022, Amarin reported $366.5 million in income, down practically 37% from the prior yr. In preliminary second quarter 2023 outcomes reported Tuesday, gross sales of the drug had been $65 million, down from $85 million within the first quarter.
Amarin mentioned the restructuring will lower jobs primarily within the firm’s U.S. gross sales drive, which has already been lower. Final yr, Amarin applied price slicing that slashed its U.S. gross sales workers from 300 to 75. The agency can be exploring methods to develop income and compete towards generics. A type of methods is providing a licensed generic—Vascepa that’s marketed by Amarin however with out the model title on its label or the model title worth. Whereas launching its personal generic Vascepa will higher allow Amarin to compete towards subject of generic variations now out there, it should additionally erode the gross sales of the model title product. Amarin mentioned it’s weighing the timing of a licensed generic launch to make sure the corporate retains a management place out there of cardiovascular medicine derived from fish oil.
Europe will proceed to be a magnet for commercialization efforts, however the gross sales infrastructure will streamlined, Amarin mentioned. The corporate added that it might proceed its commercialization push for Vascepa in different markets.
With the appointment of Holt as CEO, interim CEO Aaron Berg will return to his position as govt vice chairman, president U.S. In a regulatory submitting, Amarin mentioned it estimates the restructuring will incur about $10 million in one-time prices, comprised largely of termination advantages.
“We’re grateful for the efforts and commitments of our impacted colleagues who’ve labored tirelessly to advance our mission within the U.S. and globally,” Berg mentioned in a ready assertion. “These are tough, however obligatory choices to greatest place Amarin for the long run and guarantee we can provide tens of millions of sufferers globally the chance to entry Vascepa/Vazkepa.”
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