AMARIN CORP PLC\UK (AMRN) SEC Filings & Earnings Calls

Generic competition in IPE market pressuring U.S. net pricing.

“Decline in U.S. sales driven by continued generic competition in the IPE market and resulting pressure on net pricing.”

Generic Competition Risk

“As a result, the following generic versions of IPE have obtained U.S. FDA approval with labeling consistent with the MARINE indication and have entered the U.S. market:” · word for word

Supply Chain Dependency

“We manage the manufacturing and supply of VASCEPA and rely on contract manufacturers in each step of our commercial and clinical product supply chain.” · word for word

COGS increased 62% due to higher volumes and partner shipments, pressuring gross margin.

“COGS: Increased $10.5 million, or 62%, reflecting increased product volumes to satisfy demand associated with our exclusive PBM relationship... and shipments to ROW partners.” · word for word

European revenue declined 9% YoY due to transition to partnered model; quarterly volatility expected.

“European revenue was attributable to moving to a partnered sales model in the second half of 2025... European sales will vary quarter to quarter.”

Restructuring charges of $3.3M continue; nearly all costs incurred but execution risk remains.

“Restructuring: The Company recognized $3.3 million in Q1 2026 related to the continued implementation of the Global Restructuring.” · word for word

Generic Competition Erosion

“As a result, the following generic versions of icosapent ethyl have obtained U.S. FDA approval with labeling consistent with the MARINE indication of VASCEPA and have entered the U.S. market:” · word for word

Antitrust Litigation Exposure

“The Company is named as a defendant in six putative antitrust class action lawsuits in the District Court for the District of New Jersey” · word for word

Gross Margin Compression

“Our overall gross margin on product sales for the three months ended March 31, 2026 and 2025 was 37% and 59%, respectively. The decrease in gross margin is primarily as a result of a change in customer mix.” · word for word

Restructuring Execution Risk

“During the three months ended March 31, 2026, the Company recognized approximately $3.3 million of restructuring expense reflected on the condensed consolidated statement of operations related to the reduction in force” · word for word

Supply Chain Concentration

“The Company currently has manufacturing agreements with multiple independent API manufacturers and several independent API encapsulators and packagers for VASCEPA manufacturing.” · word for word

Shareholder rejection of pre-emption disapplication could limit equity compensation flexibility

“At the 2025 Annual General Meeting, our shareholders rejected a similar proposal for our directors to issue shares in the Company without such issuance being subject to pre-emption rights.” · word for word

Concentration of activist investor stake may lead to strategic disruption

“Sarissa Capital Management LP (1) 33,470,000 7.98 %” · word for word

Generic competition eroding U.S. market share and pricing

“Our share of the icosapent ethyl market has decreased to approximately 47% in the year ended December 31, 2025 from approximately 53% in the year ended December 31, 2024.” · word for word

PBM formulary exclusion and access barriers

“a large national PBM notified the Company that effective July 1, 2024, the PBM would no longer cover VASCEPA as the exclusive icosapent ethyl product for its commercial national formularies” · word for word

Supply chain concentration risk

“If our third-party manufacturing capacity is not appropriately qualified and/or compliant with applicable regulatory requirements, we may not be able to supply sufficient quantities of VASCEPA to meet anticipated demand.” · word for word

Revenue decline across all geographies; U.S. pricing pressure and European transition risk.

“Total Net Revenue down 21% YoY; U.S. down 7%, Europe down 42%, ROW down 74%”

Restructuring execution risk; remaining costs and savings realization.

“Restructuring costs $36.2M of $37-40M expected; $31M of $70M savings realized”

Restructuring cost estimate increased from $30-37M to $37-40M.

“Expected restructuring costs to range from $37 - $40 million, up from the prior estimate of $30 - $37 million.” · word for word

Generic IPE competition in U.S. market; share >50% but competitive pressure remains.

“Sustained VASCEPA’s market leadership across all available IPE products (brand and generic) with year-end 2025 share greater than 50% of IPE prescriptions.” · word for word

Generic competition in U.S.

“the following generic versions of icosapent ethyl have obtained U.S. FDA approval with labeling consistent with the MARINE indication and have entered the U.S. market” · word for word

Reimbursement uncertainty in Europe

“The time required to secure reimbursement varies from country to country and cannot be reliably predicted.” · word for word

Inventory overhang

“As of September 30, 2025, we had inventory of $193.8 million, of which 49% is inventory approved for use in North America.” · word for word

International revenue decline (Europe -5%, ROW -48%) due to transition to partnered model; execution risk in new markets.

“Europe $4.1M vs $4.3M, (5)% ... Rest-of-World $3.6M vs $6.9M, (48)% ... reflecting the initial transition to a partnered model with Recordati”

Dependence on US market for growth; US revenue concentration risk.

“U.S. $40.9M vs $30.6M, +34% ... Total Net Revenue $49.7M”