Der Kurs ist ein Witz, 321 Millionen US Dollar auf der Bank, keine Schulden und 8 Millionen positiver cash flow im Q3 2023:
Amarin meldet Finanzergebnisse für das dritte Quartal 2023
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Amarin Corporation plc
Mi, 1. November 2023 um 12:00 Uhr GMT+1
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Amarin Corporation plc
Amarin Corporation plc
-- Das Unternehmen meldete im dritten Quartal 66 einen Gesamtnettoumsatz von 2023 Millionen US-Dollar --
- Positiver Cashflow in Höhe von 8 Mio. $ im Quartal, das fünfte Quartal in Folge mit positivem Cashflow1; Barmittelposition zum Quartalsende von 321 Millionen US-Dollar --
-- Das Unternehmen erzielt weiterhin einen signifikanten Gewinn in den USA durch den verlängerten Lebenszyklus und die Marktführerschaft der Marke VASCEPA® --
-- Frühe Fortschritte bei der Markteinführung in europäischen Ländern durch neue Führung --
-- Das Unternehmen wird heute um 8:00 Uhr ET eine Telefonkonferenz abhalten --
DUBLIN, Irland und BRIDGEWATER, N.J., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) gab heute die Finanzergebnisse für das am 30. September 2023 endende Quartal bekannt und gab ein Update zur Geschäftstätigkeit des Unternehmens.
"Da wir uns darauf konzentrieren, Ergebnisse zu erzielen, die den Aktionärswert steigern, gibt es Gründe, optimistisch in die Zukunft von Amarin zu blicken", sagte Patrick Holt, President und CEO von Amarin. "Wir verfügen über eine starke Bilanz mit 321 Millionen US-Dollar an Barmitteln, darunter fünf aufeinanderfolgende Quartale mit positivem Cashflow und ohne Schulden, was beweist, dass wir unsere Barmittel effektiv verwalten können. In den USA verlängern wir weiterhin den Lebenszyklus und behalten die Marktführerschaft mit der Marke VASCEPA,® die einen bedeutenden Gewinn und Cashflow für das Gesamtgeschäft bietet. Wir haben noch mehr Arbeit vor uns, um die Umsätze in Europa zu steigern, aber ich bin ermutigt durch die Auswirkungen der neuen Führung und unseres Teams, das in den kürzlich gestarteten Ländern erste Ergebnisse liefert. Wir haben auch erste Fortschritte bei Partnern im Rest der Welt gesehen, insbesondere bei unserer Chance in China."
"Für unser Team ist unser Weg in die Zukunft einfach: Wir wollen die Anzahl der Patienten mit unserem Produkt maximieren, was die operative Dynamik beschleunigen und den Aktionärswert steigern wird", sagte Holt.
Europa
Amarin hat sowohl bei den kommerziellen als auch bei den Preis- und Erstattungsbemühungen in Europa weitere Fortschritte gemacht.
Amarin hat eine frühe Markteinführung von VAZKEPA in mehreren europäischen Ländern im Gange, darunter Großbritannien (England, Wales und Schottland), Spanien und die Niederlande, wobei erste positive Fortschritte durch die Einführungsbemühungen unter neuer Führung erzielt wurden.
In addition to these launch activities, the team in Europe is continuing to advance various Health Technology Assessment (HTA) processes and pricing & reimbursement discussions in all markets where Amarin has submitted market access dossiers. In July and August 2023, Amarin announced the following positive pricing and reimbursement milestones:
The Spanish Drug Pricing Committee recommended the national reimbursement of VAZKEPA® (icosapent ethyl) to reduce the risk of cardiovascular (CV) events in patients with high cardiovascular risk.
The Dutch Ministry of Health approved VAZKEPA for national reimbursement in the Netherlands.
The Scottish Medicines Consortium (SMC) accepted VAZKEPA for reimbursement.
Although Italy's AIFA issued a negative reimbursement decision for VAZKEPA in that country, Amarin has finalized a new path forward to seek access to VAZKEPA for Italian patients by the end of 2024. In France, Amarin continues to progress its access strategy for VAZKEPA with the national health authorities. The Company does not expect this process to conclude in 2024. In Germany, Amarin is exploring new options to re-enter the market, and the Company will update investors in the coming quarters.
United States
U.S. product net revenue was $62.4 million in the third quarter of 2023, a decline of $2.2 million versus the second quarter of 2023, a decrease of 3% sequentially. The Company maintains approximately 57% market share of IPE (icosapent ethyl) prescriptions despite generic competition as the U.S. commercial organization continues an efficient support of branded VASCEPA.
During the third quarter of 2023, Amarin maintained its existing access for VASCEPA in exclusive accounts, representing approximately 43% of all Commercial and Part D lives on a weighted average basis.
The U.S. business continues to be profitable and support our global operations. Amarin continues to actively monitor key performance indicators in the U.S. market and is prepared to execute multiple strategies to support the business moving forward.
Rest of World
In China, Amarin’s partner Edding Pharm launched VASCEPA in October to treat adult patients with severe hypertriglyceridemia (≥ 500 mg/dL). Edding also announced that it has submitted its regulatory filing with the National Medical Products Administration (NMPA) for the Company’s new indication marketing application for VASCEPA to potentially treat cardiovascular risk reduction (CVRR). The Company is now awaiting the agency’s acceptance of that filing.
Amarin is in the second year of a three-year plan to submit and obtain regulatory approval in 20 or more additional countries and regions around the world to ensure that patients in the top 50 cardiometabolic markets worldwide can benefit from VASCEPA/VAZKEPA.
In the third quarter of 2023, Amarin signed an exclusive commercialization agreement with Lotus Pharmaceuticals to distribute and commercialize VAZKEPA across 10 countries in Southeast Asia and South Korea. Amarin also announced an exclusive marketing and commercial agreement with Neopharm for VAZKEPA in Israel.
Financial Update
Total net revenue for the three months ended September 30, 2023, was $66.1 million, compared to $89.9 million in the corresponding period of 2022, a decrease of 27%. Total net revenue in the quarter includes $64.9 million in net product revenue and approximately $1.2 million in licensing and royalty revenue.
Net product revenue for the three months ended September 30, 2023, was $64.9 million, compared to $89.2 million in the corresponding period of 2022, a decrease of 27%. This decrease was driven by generic competition resulting in lower volume, as well as increased net pricing pressure offset primarily by a one-time Medicaid rebate adjustment of $6.5 million, versus the third quarter of 2022. In Europe revenue was $0.8 million in the third quarter of 2023.
Amarin recognized licensing and royalty revenue of $1.2 million and $0.7 million during the three months ended September 30, 2023 and 2022, respectively, from VASCEPA-related commercial sales from our partners in Canada, the China region and the Middle East, as well as an upfront licensing fee from our partner in South Korea and ASEAN.
Cost of goods sold for the three months ended September 30, 2023, was $36.2 million, compared to $27.0 million in the corresponding period of 2022. Amarin’s overall gross margin on net product revenue for the three months ended September 30, 2023 was 44%, compared with 70% for the corresponding period of 2022. As a result of amended supplier agreements Amarin recognized a charge of $12.7 million during the three months ended September 30, 2023. During the three months ended September 30, 2022, Amarin also amended a supplier agreement resulting in a charge of $3.1 million. Excluding the impact of these one-time items, gross margin was 64% and 73% for the three months ended September 30, 2023 and 2022, respectively.
Selling, general and administrative expenses for the three months ended September 30, 2023, was $45.5 million, compared to $58.7 million in the corresponding period of the prior year. This decrease was primarily due to the implementation of our previously announced cost reduction plan.
Research and development expenses for the three months ended September 30, 2023, were $5.1 million, compared to $5.8 million in the corresponding period of the prior year. This decrease was primarily driven by the implementation of our previously announced cost reduction plan.
Restructuring expense for the three months ended September 30, 2023 was $0.7 million compared to $3.5 million in the corresponding period of the prior year. The charge in the current year is due to the implementation of the Organizational Restructuring Plan which was approved during the second quarter of 2023 and announced on July 18, 2023, which resulted in a reduction of our entire U.S. sales field force, while maintaining our managed care and trade organization to support U.S. commercial efforts, as well as a reduction of approximately 30% of non-sales positions. The prior year charge was primarily the result of the discontinuation of the German operations as a result of not being able to reach a viable agreement on the reimbursement price for VAZKEPA in Germany.
Under U.S. GAAP, Amarin reported a net loss of $19.3 million for the three months ended September 30, 2023, or basic and diluted loss per share of $0.05. For the three months ended September 30, 2022, Amarin reported a net loss of $5.1 million, or basic and diluted loss per share of $0.01. Amarin reported aggregate cash and investments of $321 million as of September 30, 2023 compared to $306 million as of September 30, 2022.
2023 Financial Outlook
Amarin continues to make progress on reducing operating expenses and managing its cash position and on-track to deliver $40 million of annual savings based on the reduction in force announced in July 2023. With the recent cash preservation initiatives, Amarin reiterates its belief that current cash and investments and other assets are adequate to support continued operations, including European launch activities.
Conference Call and Webcast Information
Amarin will host a conference call on November 1, 2023, at 8:00 a.m. ET to discuss this information. The conference call can be accessed on the investor relations section of the company's website at www.amarincorp.com, or via telephone by dialing 877-545-0523 within the United States, 973-528-0016 from outside the United States, and referencing conference ID 991868. A replay of the call will be made available for a period of two weeks following the conference call. To listen to a replay of the call, dial 877-481-4010 from within the United States and 919-882-2331 from outside of the United States, and reference conference ID 49172. A replay of the call will also be available through the company's website shortly after the call.
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