AMARIN CORP PLCUK

Previous wording

On July 18, 2023, we announced that we were implementing a new Organizational Restructuring Program, or the ORP, resulting in the elimination and consolidation of certain roles across our organization, both in the U.S. and abroad and representing a reduction of our total employee base by approximately 30%. The ORP was implemented following a review of our business and to better position the organization for a new strategic focus. The ORP resulted in an operating cost reduction of $50.0 million annually. Our refocused strategic priorities and restructuring plan focuses on three core areas:

Current wording

On July 18, 2023, we announced that we were implementing a new Organizational Restructuring Program, or the ORP, resulting in the elimination of our entire U.S. sales force and elimination and consolidation of certain other roles across our organization, both in the U.S. and abroad and representing a reduction of our total employee base by approximately 30%. The ORP was implemented following a review of our business and to better position the organization for a new strategic focus. The ORP resulted in an operating cost reduction of $50.0 million annually.

Previous wording

VASCEPA is sold principally to a limited number of major wholesalers, as well as selected regional wholesalers and retail and mail order pharmacy providers, or collectively, our distributors or our customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients. Since VASCEPA was made commercially available in 2013, approximately 25 million estimated normalized total prescriptions of VASCEPA have been reported by Symphony Health. In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, several of our patents covering the MARINE indication were declared invalid. As a result, the following generic versions of VASCEPA have obtained U.S. FDA approval with labeling consistent with the MARINE indication and have entered the U.S. market:

Current wording

VASCEPA is sold principally to a limited number of major wholesalers, as well as selected regional wholesalers and retail and mail order pharmacy providers, or collectively, our distributors or our customers, most of whom in turn resell VASCEPA to retail pharmacies for subsequent resale to patients. Since VASCEPA was made commercially available in 2013, approximately 26 million estimated normalized total prescriptions of VASCEPA have been reported by Symphony Health. In 2020, following our unsuccessful appeals of a court ruling in favor of two generic drug companies, Dr. Reddy’s Laboratories, Inc., or Dr. Reddy’s, and Hikma Pharmaceuticals USA Inc., or Hikma, and certain of their affiliates, several of our patents covering the MARINE indication were declared invalid. As a result, 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:

Previous wording

(1) Strides Pharma licensed its rights to the generic version of VASCEPA to Amneal Pharmaceuticals.

Current wording

(1) Strides Pharma licensed its rights to the generic version of icosapent ethyl to Amneal Pharmaceuticals.

Previous wording

(2) Ascent Pharmaceuticals, Inc. licensed its rights to the generic version of VASCEPA to Camber Pharmaceuticals, Inc.

Current wording

(2) Ascent Pharmaceuticals, Inc. licensed its rights to the generic version of icosapent ethyl to Camber Pharmaceuticals, Inc. and XL Care Pharmaceuticals, Inc.

Previous wording

Launch of VAZKEPA in individual countries depends on the timing of achieving product reimbursement on a country-by-country basis. To date we have filed 15 dossiers to gain market access in European countries, including in all of the largest countries in Europe. In most European countries, securing product reimbursement is a requisite to launching. In certain countries, such as Denmark, individual patient reimbursement is allowed prior to national reimbursement. In countries where individual price reimbursement is allowed prior to national reimbursement, product can be made available on a patient-by-patient basis, while the national reimbursements negotiations are ongoing. In all countries, securing adequate reimbursement is a requisite for commercial success of any therapeutic. The time required to secure reimbursement tends to vary from country to country and cannot be reliably predicted. While we believe that we have strong arguments regarding the cost effectiveness of VAZKEPA, the success of such reimbursement negotiations have a significant impact on the assessment of the commercial opportunity of VAZKEPA in Europe. Through the date of this Quarterly Report, we received marketing authorization by the MHRA and the European Medicines Agency, or EMA, and subsequently we have made VAZKEPA available under individual reimbursement or received national reimbursement and launched commercial operations in the following countries, respectively.

Current wording

Launch of VAZKEPA in individual countries depends on the timing of achieving product reimbursement on a country-by-country basis. To date we have filed 15 dossiers to gain market access in European countries, including in all of the largest countries in Europe. In most European countries, securing product reimbursement is a requisite to launching. In certain countries, such as Denmark, individual patient reimbursement is allowed prior to national reimbursement. In countries where individual price reimbursement is allowed prior to national reimbursement, product can be made available on a patient-by-patient basis, while the national reimbursements negotiations are ongoing. In all countries, securing adequate reimbursement is a requisite for commercial success of any therapeutic. The time required to secure reimbursement varies from country to country and cannot be reliably predicted. While we believe that we have strong arguments regarding the cost effectiveness of VAZKEPA, the success of such reimbursement negotiations have a significant impact on the assessment of the commercial opportunity of VAZKEPA in Europe. Through the date of this Quarterly Report, we received marketing authorization by the MHRA and the European Medicines Agency, or EMA, and subsequently we have made VAZKEPA available under individual reimbursement or received national reimbursement and launched commercial operations in the following countries, respectively.

Previous wording

We continue to advance our pricing and reimbursement activities to drive access in remaining geographies, including those where progress has been delayed. We are leveraging third-party relationships for various support activities and are implementing an impactful and cost-effective hybrid commercial model balancing optimally digital and face-to-face approach for more impact and cost efficiency, which is or will be utilized throughout Europe as launches are rolled out.

Current wording

We continue to advance our pricing and reimbursement activities to drive access in remaining geographies, including those where progress has been delayed. We are leveraging third-party relationships for various support activities and are implementing an impactful and cost-effective hybrid commercial model balancing optimally digital and face-to-face approaches to drive greater impact and improved cost efficiency, which is or will be utilized throughout Europe as launches are rolled out.

Previous wording

As discussed above, one of the core areas of focus from our ORP is continuing to work on generating revenue from our partnerships in key international markets, including Canada, MENA, China, Australia and New Zealand and we will continue to explore additional partnerships.

Current wording

One of the core areas of focus from our ORP is continuing to work on generating revenue from our partnerships in key international markets, including Canada, MENA, China, Australia and New Zealand and ASEAN and South Korea and we will continue to explore additional partnerships.

Previous wording

In February 2015, we entered into an exclusive agreement with Eddingpharm (Asia) Macao Commercial Offshore Limited, or Edding, to develop and commercialize VASCEPA capsules in what we refer to as the China Territory, consisting of the territories of Mainland China, Hong Kong, Macau and Taiwan. Edding, with our support, conducted a clinical trial of VASCEPA in China, which evaluated the effect of VASCEPA on patients with very high triglyceride levels (≥500 mg/dL). In November 2020, we announced statistically significant topline positive results from this Phase 3 clinical trial of VASCEPA conducted by Edding. The study, which investigated VASCEPA as a treatment for patients with very high triglycerides (≥500 mg/dL), met its primary efficacy endpoint as defined in the clinical trial protocol and demonstrated a safety profile similar to placebo. There were no treatment-related serious adverse events in this study. On February 9, 2021, we announced that the regulatory review processes in Mainland China and Hong Kong had commenced. On February 23, 2022, the Hong Kong Department of Health completed their regulatory evaluation and approved the use of VASCEPA under the REDUCE-IT indication. In Mainland China, the NMPA accepted for review the new drug application for VASCEPA, submitted by Edding, based on the results from the Phase 3 clinical trial and the results from our prior studies of VASCEPA. In Mainland China, on October 10, 2022, following the completion of product testing by the China National Institutes for Food and Drug Control, or NIFDC, the final NMPA review of the VASCEPA NDA was initiated. The Company announced on June 1, 2023 that Edding received approval from the NMPA for VASCEPA in Mainland China under the MARINE indication and launched commercially in October 2023. In October 2023, Edding's submission of a regulatory filing to the NMPA for VASCEPA under the REDUCE-IT indication was accepted. On June 28, 2024, Edding received approval from the NMPA for VASCEPA in Mainland China under the REDUCE-IT indication.

Current wording

Kong had commenced. On February 23, 2022, the Hong Kong Department of Health completed their regulatory evaluation and approved the use of VASCEPA under the REDUCE-IT indication. In Mainland China, the NMPA accepted for review the new drug application for VASCEPA, submitted by Edding, based on the results from the Phase 3 clinical trial and the results from our prior studies of VASCEPA. In Mainland China, on October 10, 2022, following the completion of product testing by the China National Institutes for Food and Drug Control, or NIFDC, the final NMPA review of the VASCEPA NDA was initiated. The Company announced on June 1, 2023 that Edding received approval from the NMPA for VASCEPA in Mainland China under the MARINE indication and launched commercially in October 2023. In October 2023, Edding's submission of a regulatory filing to the NMPA for VASCEPA under the REDUCE-IT indication was accepted. On June 28, 2024, Edding received approval from the NMPA for VASCEPA in Mainland China under the REDUCE-IT indication.

Previous wording

In February 2023, the Company entered into an agreement with CSL Seqirus, or CSL, to secure pricing and reimbursement, commercialize and distribute VAZKEPA in Australia and New Zealand. In July 2023, the Company entered into an agreement with Lotus Pharmaceuticals to commercialize and distribute VAZKEPA in South Korea and nine countries in Southeast Asia. In August 2023, the Company entered into an agreement with Neopharm (Israel) 1996 Ltd., or Neopharm, to distribute VAZKEPA in Israel, Gaza, West Bank, and the territories of the Palestinian Authority. In May 2024, the Company entered into an agreement with Vianex

Current wording

In February 2023, the Company entered into an agreement with CSL Seqirus, or CSL, to secure pricing and reimbursement, commercialize and distribute VAZKEPA in Australia and New Zealand. In October 2024, CSL obtained pricing approval for VAZKEPA in Australia. In July 2023, the Company entered into an agreement with Lotus Pharmaceuticals to commercialize and distribute VAZKEPA in South Korea and nine countries in Southeast Asia. In August 2023, the Company entered into an agreement with Neopharm (Israel) 1996 Ltd., or Neopharm, to distribute VAZKEPA in Israel, Gaza, West Bank, and the territories of the Palestinian Authority. In May 2024, the Company entered into an agreement with Vianex S.A. to import, register, distribute and commercialize VAZKEPA in Greece. The Company will be responsible for supplying finished product to these partners. We continue to assess other potential partnership opportunities for VASCEPA with companies outside of the United States and Europe with the intention of partnering in all other international markets where VASCEPA receives local regulatory approval.

Previous wording

Based on REDUCE-IT results, as of the date of the filing of this Quarterly Report, more than 40 clinical treatment guidelines, consensus statements or scientific statements from medical societies or journals have been updated recommending the use of icosapent ethyl in appropriate at-risk patients, including those statements which we were informed of by our global partners in Australia, Canada, China and the Middle East as well as guidelines or statements which were newly received during the second quarter of 2024 as listed below:

Current wording

Based on REDUCE-IT results, as of the date of the filing of this Quarterly Report, more than 40 clinical treatment guidelines, consensus statements or scientific statements from global medical societies or journals have been updated recommending the use of icosapent ethyl in appropriate at-risk patients, including those statements which we were informed of by our global partners in Australia, Canada, China and the Middle East as well as guidelines or statements which were newly received during the third quarter of 2024 as listed below:

Previous wording

In the first six months of 2024, Amarin and global medical and scientific collaborators supported over 15 publications inclusive of accepted abstracts, posters, and accepted journal manuscripts.

Current wording

In the first nine months of 2024, we and global medical and scientific collaborators supported over 25 publications inclusive of accepted abstracts, posters, and accepted journal manuscripts.

Previous wording

We manage the manufacturing and supply of VASCEPA and rely on contract manufacturers in each step of our commercial and clinical product supply chain. These steps include active pharmaceutical ingredient, or API, manufacturing, encapsulation of the API, product packaging and supply-related logistics. Our approach to product supply procurement is designed to mitigate risk of supply interruption and maintain an environment of cost competition through diversification of contract manufacturers at each stage of the supply chain and lack of reliance on any single supplier. We have multiple U.S. FDA-approved international API suppliers, encapsulators and packagers to support the VASCEPA commercial franchise. We also have multiple international API suppliers, encapsulators and packagers to support the commercialization of VASCEPA in geographies where the drug is approved outside the United States. Not all of our suppliers approved by the U.S. FDA are approved in every other geography. The regulatory process generally requires extensive details as part of the submission provided to a country or region in connection with a company's request for regulatory approval. Suppliers must be specifically identified as part of the submission for qualification and approval for commercialization in a country or region. As a result, only supply, as approved, may be used in finished goods available for sale in a specific country or region. The amount of supply we seek to purchase in future periods will depend on the level of growth of VASCEPA revenues and minimum purchase commitments with certain suppliers. Beginning in 2022, we reviewed our contractual supplier purchase obligations and began taking steps to amend supplier agreements to align supply arrangements with current and future market demand, while we decrease our current inventory levels primarily related to North America approved inventory. As of June 30, 2024, we had inventory of $310.7 million, of which 70% is inventory approved for use in North America. We continue to negotiate with our contract suppliers to align our supply arrangements with current and future global market demand.

Current wording

We manage the manufacturing and supply of VASCEPA and rely on contract manufacturers in each step of our commercial and clinical product supply chain. These steps include active pharmaceutical ingredient, or API, manufacturing, encapsulation of the API, product packaging and supply-related logistics. Our approach to product supply procurement is designed to mitigate risk of supply interruption and maintain an environment of cost competition through diversification of contract manufacturers at each stage of the supply chain and lack of reliance on any single supplier. We have multiple U.S. FDA-approved international API suppliers, encapsulators and packagers to support the VASCEPA commercial franchise. We also have multiple international API suppliers, encapsulators and packagers to support the commercialization of VASCEPA in geographies where the drug is approved outside the United States. Not all of our suppliers approved by the U.S. FDA are approved in every other geography. The regulatory process generally requires extensive details as part of the submission provided to a country or region in connection with a company's request for regulatory approval. Suppliers must be specifically identified as part of the submission for qualification and approval for commercialization in a country or region. As a result, only supply, as approved, may be used in finished goods available for sale in a specific country or region. The amount of supply we seek to purchase in future periods will depend on the level of growth of VASCEPA revenues and minimum purchase commitments with certain suppliers. Beginning in 2022, we reviewed our contractual supplier purchase obligations and began taking steps to amend supplier agreements to align supply arrangements with current and future market demand, while we decrease our current inventory levels primarily related to North America approved inventory. As of September 30, 2024, we had inventory of $298.0 million, of which 70% is inventory approved for use in North America. We continue to negotiate with our contract suppliers to align our supply arrangements with current and future global market demand.

Previous wording

Cost of goods sold. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, quality assurance, insurance, and other indirect manufacturing, logistics and product support costs. The cost of the API included in cost of goods sold reflects the average cost method of inventory valuation and relief. This average cost reflects the actual purchase price of VASCEPA API. Our cost of goods sold is not materially impacted by whether we sell VASCEPA directly in a country or we sell VASCEPA to a commercial partner for resale in a country. In the three and six months ended June 30, 2023, we incurred costs within Cost of goods sold - restructuring inventory related to steps taken to amend supplier agreements to align supply arrangements with current and future market demand.

Current wording

Cost of goods sold. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, quality assurance, insurance, and other indirect manufacturing, logistics and product support costs. The cost of the API included in cost of goods sold reflects the average cost method of inventory valuation and relief. This average cost reflects the actual purchase price of VASCEPA API. Our cost of goods sold is not materially impacted by whether we sell VASCEPA directly in a country or we sell VASCEPA to a commercial partner for resale in a country. In the three and nine months ended September 30, 2023, we incurred costs within Cost of goods sold - restructuring inventory related to steps taken to amend supplier agreements to align supply arrangements with current and future market demand.

Previous wording

Total revenue, net. We recorded total revenue, net, of $67.5 million and $80.2 million during the three months ended June 30, 2024 and 2023, respectively, a decrease of $12.7 million, or 16%. Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the United States. In addition to the United States, during the three months ending June 30, 2024, we also sold VASCEPA by prescription in certain countries in Europe as well as certain countries outside of the United States and Europe, such as China and Canada, through collaborations with third-party companies. As further discussed below, the aforementioned decrease consists of a $20.8 million decrease in U.S. net product revenue offset in part by a $3.1 million increase in net product revenue outside of the United States and a $5.0 million increase in licensing and royalty revenue.

Current wording

Total revenue, net. We recorded total revenue, net, of $42.3 million and $66.1 million during the three months ended September 30, 2024 and 2023, respectively, a decrease of $23.8 million, or 36%. Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the United States. In addition to the United States, during the three months ending September 30, 2024, we also sold VASCEPA by prescription in certain countries in Europe as well as certain countries outside of the United States and Europe, such as China and Canada, through collaborations with third-party companies. As further discussed below, the aforementioned decrease consists in part of a $31.8 million decrease in U.S. net product revenue and a $0.7 million decrease in licensing and royalty revenue offset by a $8.6 million increase in net product revenue outside of the United States.

Previous wording

Product revenue, net. We recorded product revenue, net, of $47.5 million and $65.2 million during the three months ended June 30, 2024 and 2023, respectively, a decrease of $17.7 million, or 27%. This decrease was due primarily to a 32% decrease in VASCEPA sales in the United States.

Current wording

Product revenue, net. We recorded product revenue, net, of $41.9 million and $64.9 million during the three months ended September 30, 2024 and 2023, respectively, a decrease of $23.1 million, or 36%. This decrease was due primarily to a 51% decrease in VASCEPA sales in the United States.

Previous wording

We recorded U.S. product revenue, net, of $91.9 million and $146.6 million during the six months ended June 30, 2024 and 2023, respectively. This decrease was due to a decline in net selling price as a result of the impact from generic competition in the market.

Current wording

We recorded U.S. product revenue, net, of $30.6 million and $62.4 million during the three months ended September 30, 2024 and 2023, respectively. This decrease was due to a decline in net selling price as a result of the impact from generic competition in the market as well as a decrease in volume primarily related to the loss of a large national pharmacy benefit manager, or PBM, going from exclusive to no longer covering VASCEPA.

Previous wording

The overall icosapent ethyl market in the United States, based on prescription levels reported by Symphony Health, decreased for the three months ended June 30, 2024 by 1% as compared to the three months ended June 30, 2023. Our share of the icosapent ethyl market has increased to approximately 59% in the three months ended June 30, 2024 compared to approximately 57% in the three months ended June 30, 2023. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions increased by 2% in the three months ended June 30, 2024 compared to the three months ended June 30, 2023.

Current wording

The overall icosapent ethyl market in the United States, based on prescription levels reported by Symphony Health, decreased for the three months ended September 30, 2024 by 1% as compared to the three months ended September 30, 2023. Our share of the icosapent ethyl market has decreased to approximately 50% in the three months ended September 30, 2024 compared to approximately 58% in the three months ended September 30, 2023. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 13% in the three months ended September 30, 2024 compared to the three months ended September 30, 2023.

Previous wording

For the three months ended June 30, 2024, we recorded $0.2 million of product revenue, net, from our collaboration partners compared to nil during the three months ended June 30, 2023.

Current wording

For the three months ended September 30, 2024, we recorded $6.9 million of product revenue, net, from our collaboration partners compared to $1.8 million during the three months ended September 30, 2023.

Previous wording

Licensing and royalty revenue. Licensing and royalty revenue during the three months ended June 30, 2024 and 2023 was $20.0 million and $15.0 million, respectively, an increase of $5.0 million, or 33%. Licensing and royalty revenue has increased primarily due to recognition of the REDUCE-IT indication milestone in China offset by recognition of previously achieved milestone payments from HLS in the prior year. Licensing and royalty revenue recognized in the current period relates to the recognition of amounts received in connection with the following VASCEPA licensing agreements:

Current wording

Licensing and royalty revenue. Licensing and royalty revenue during the three months ended September 30, 2024 and 2023 was $0.4 million and $1.2 million, respectively, a decrease of $0.7 million, or 61%. Licensing and royalty revenue has decreased primarily due to recognition of previously achieved milestone payments from Edding in the prior year.

Previous wording

Licensing and royalty revenue recognized in the prior period relates to partial recognition of the above upfront and previously achieved milestones, excluding the REDUCE-IT indication approval, as well as below amounts received in connection with the following VASCEPA licensing agreements:

Current wording

Licensing and royalty revenue recognized in the prior period relates to the recognition of amounts received in connection with the following VASCEPA licensing agreements:

Previous wording

The upfront and milestone payments from Edding and HLS were being recognized over the estimated period in which we were required to provide regulatory and development support pursuant to the respective agreements which were satisfied in 2024 and 2023, respectively. The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and changes in estimates of the timing and level of support required.

Current wording

The upfront and milestone payments from Edding were being recognized over the estimated period in which we were required to provide regulatory and development support pursuant to the respective agreements which were satisfied in June 2024. The amount of licensing and royalty revenue is expected to vary from period to period based on timing of milestones achieved and changes in estimates of the timing and level of support required.

Previous wording

Cost of goods sold. Cost of goods sold during the three months ended June 30, 2024 and 2023 was $24.7 million and $37.5 million, respectively, a decrease of $12.8 million, or 34%. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of VASCEPA API. During the three months ended June 30, 2023, we recorded as cost of goods sold - restructuring inventory $14.3 million as a result of amendments to our supplier agreements.

Current wording

Cost of goods sold. Cost of goods sold, inclusive of restructuring charges, during the three months ended September 30, 2024 and 2023 was $26.0 million and $36.2 million, respectively, a decrease of $10.2 million, or 28%. Cost of goods sold includes the cost of API for VASCEPA on which revenue was recognized during the period, as well as the associated costs for encapsulation, packaging, shipment, supply management, insurance and quality assurance. The cost of the API included in cost of goods sold reflects the average cost of API included in inventory. This average cost reflects the actual purchase price of VASCEPA API. During the three months ended September 30, 2023, we recorded as cost of goods sold - restructuring inventory $12.7 million as a result of amendments to our supplier agreements.

Previous wording

Our overall gross margin on product sales for the three months ended June 30, 2024 and 2023 was 48% and 42%, respectively. Excluding the restructuring inventory charge, gross margin was 48% and 64% for the three months ended June 30, 2024 and 2023, respectively. The decrease in gross margin is primarily as a result of a decrease in net selling price.

Current wording

Our overall gross margin on product sales for the three months ended September 30, 2024 and 2023 was 38% and 44%, respectively. Excluding the restructuring inventory charge, gross margin was 38% and 64% for the three months ended September 30, 2024 and 2023, respectively. The decrease in gross margin is primarily as a result of a decrease in net selling prices.

Previous wording

Selling, general and administrative expense. Selling, general and administrative expense for the three months ended June 30, 2024 and 2023 was $38.5 million and $51.0 million, respectively, a decrease of $12.4 million, or 24%. Selling, general and administrative expenses for the three months ended June 30, 2024 and 2023 are summarized in the table below:

Current wording

Selling, general and administrative expense. Selling, general and administrative expense for the three months ended September 30, 2024 and 2023 was $36.9 million and $45.5 million, respectively, a decrease of $8.6 million, or 19%. Selling, general and administrative expenses for the three months ended September 30, 2024 and 2023 are summarized in the table below:

Previous wording

Selling expense for the six months ended June 30, 2024 and 2023 was $40.9 million and $64.5 million, respectively, a decrease of $23.6 million, or 37%. This decrease is primarily due to a reduction in costs associated with our ORP and cost reduction plans resulting in decreased promotional initiatives, reduced travel and elimination of our U.S. sales force.

Current wording

Selling expense for the three months ended September 30, 2024 and 2023 was $18.8 million and $24.1 million, respectively, a decrease of $5.3 million, or 22%. This decrease is primarily due to a reduction in costs associated with decreased promotional and marketing initiatives as well as other cost optimization initiatives.

Previous wording

General and administrative expense for the three months ended June 30, 2024 and 2023 was $14.5 million and $17.7 million, respectively, a decrease of $3.2 million, or 18%. This decrease is primarily due to a decrease in employee-related costs as a result of the reduction in force from the ORP and cost reduction plans.

Current wording

General and administrative expense for the three months ended September 30, 2024 and 2023 was $14.3 million and $17.8 million, respectively, a decrease of $3.5 million, or 19%. This decrease is primarily due to a decrease in employee-related costs as a result of the reduction in force from the 2023 ORP and cost reduction plans.

Previous wording

Non-cash stock-based compensation expense for the six months ended June 30, 2024 and 2023 was $7.7 million and $5.3 million, respectively, an increase of $2.4 million, or 46%. Non-cash stock-based compensation expense represents the estimated costs associated with equity awards issued to internal personnel supporting our selling, general and administrative functions. The increase is due to prior years reversal of expense associated with our former CEO's resignation, as well as certain performance-based awards as it was no longer deemed probable that the performance criteria for vesting would be achieved within the required timeframe.

Current wording

Non-cash stock-based compensation expense for the three months ended September 30, 2024 and 2023 was $3.8 million and $3.7 million, respectively, an increase of $0.2 million, or 5%. Non-cash stock-based compensation expense represents the estimated costs associated with equity awards issued to internal personnel supporting our selling, general and administrative functions.

Previous wording

Research and development expense. Research and development expense for the three months ended June 30, 2024 and 2023 was $4.7 million and $5.6 million, respectively, a decrease of $0.9 million, or 16%. Research and development expenses for the three months ended June 30, 2024 and 2023 are summarized in the table below:

Current wording

Research and development expense. Research and development expense for the three months ended September 30, 2024 and 2023 was $4.5 million and $5.1 million, respectively, a decrease of $0.6 million, or 11%. Research and development expenses for the three months ended September 30, 2024 and 2023 are summarized in the table below:

Previous wording

REDUCE-IT study and publications expenses consist primarily of costs incurred to maintain the REDUCE-IT trial data as well as support provided to present at conferences and providing data to be published in medical journals.

Current wording

REDUCE-IT study and publications expenses consist primarily of costs incurred to maintain the REDUCE-IT trial data as well as support provided to present at conferences and to provide data to be published in medical journals.

Previous wording

Fixed-dose combination expenses are primarily related to cost associated with developmental activities of a fixed-dose combination of VASCEPA and a statin which began in 2022 and subsequently deprioritized during 2023.

Current wording

Fixed-dose combination expenses are primarily related to cost associated with developmental activities of a fixed-dose combination of VASCEPA and a statin which began in 2022 but was subsequently deprioritized during 2023.

Previous wording

Restructuring expense. Restructuring expense for the three months ended June 30, 2024 and 2023 was nil and $10.0 million, respectively, a decrease of $10.0 million, or 100%. The charge in the prior year is due to the implementation of the ORP which was approved during the second quarter 2023 and announced on July 18, 2023, which resulted in a reduction of our entire U.S. sales field force, with our managed care and trade organization continuing to support our U.S. commercial efforts, as well as a reduction of approximately 30% of non-sales positions. Refer to Note 2 Significant Accounting Policies for additional information.

Current wording

Restructuring expense. Restructuring expense for the three months ended September 30, 2024 and 2023 was nil and $0.7 million, respectively, a decrease of $0.7 million, or 100%. The charge in the prior year is due to the implementation of the ORP which was approved during the second quarter 2023 and announced on July 18, 2023, which resulted in a reduction of our entire U.S. sales field force, with our managed care and trade organization continuing to support our U.S. commercial efforts, as well as a reduction of approximately 30% of non-sales positions. Refer to Note 2 Significant Accounting Policies for additional information.

Previous wording

Interest income, net. Interest income, net, for the three months ended June 30, 2024 and 2023 was $3.3 million and $3.0 million, respectively, an increase of $0.3 million, or 9%. Interest income, net, represents income earned on cash and investment balances. The increase is primarily due to higher investment balances in the current year period compared to the prior year period.

Current wording

Interest income, net. Interest income, net, for the three months ended September 30, 2024 and 2023 was $3.4 million and $3.2 million, respectively, an increase of $0.2 million, or 5%. Interest income, net, represents income earned on cash and investment balances. The increase is primarily due to higher investment balances in the current year period compared to the prior year period.

Previous wording

(Provision for) benefit from income taxes. Provision for income taxes for the three months ended June 30, 2024 was $1.4 million and a benefit for the three months ended June 30, 2023 was $0.4 million, respectively. The provision for the three months ended June 30, 2024 is the result of changes in unrecognized tax benefits and income generated by our U.S. and foreign operations for which tax expense has been recognized based on a full year estimated U.S. and foreign income tax liability.

Current wording

Provision for income taxes. Income tax provision for the three months ended September 30, 2024 and 2023 was $3.6 million and $0.5 million, respectively. The provision for the three months ended September 30, 2024 is the result of changes in income generated by our U.S. and foreign operations for which tax expense has been recognized based on a full year estimated U.S. and foreign income tax liability.

Previous wording

Total revenue, net. We recorded total revenue, net, of $124.0 million and $166.1 million during the six months ended June 30, 2024 and 2023, respectively, a decrease of $42.1 million, or 25%. Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the United States. In addition to the United States, during the six months ended June 30, 2024, we also sold VASCEPA by prescription in certain countries in Europe as well as certain countries outside of the United States and Europe, such as China and Canada, through collaborations with third-party companies. As further discussed below, the aforementioned decrease consists of a $54.7 million decrease in U.S. net product revenue offset in part by a $7.6 million increase in net product revenue outside of the United States and a $5.0 million increase in licensing and royalty revenue.

Current wording

Total revenue, net. We recorded total revenue, net, of $166.3 million and $232.2 million during the nine months ended September 30, 2024 and 2023, respectively, a decrease of $65.9 million, or 28%. Total revenue, net, consists primarily of revenue from the sale of VASCEPA in the United States. In addition to the United States, during the nine months ended September 30, 2024, we also sold VASCEPA by prescription in certain countries in Europe as well as certain countries outside of the United States and Europe, such as China and Canada, through collaborations with third-party companies. As further discussed below, the aforementioned decrease consists of a $86.5 million decrease in U.S. net product revenue offset in part by a $16.2 million increase in net product revenue outside of the United States and a $4.3 million increase in licensing and royalty revenue.

Previous wording

Product revenue, net. We recorded product revenue, net, of $102.7 million and $149.8 million during the six months ended June 30, 2024 and 2023, respectively, a decrease of $47.2 million, or 31%. This decrease was due primarily to a 37% decrease in VASCEPA sales in the United States.

Current wording

Product revenue, net. We recorded product revenue, net, of $144.5 million and $214.7 million during the nine months ended September 30, 2024 and 2023, respectively, a decrease of $70.2 million, or 33%. This decrease was due primarily to a 41% decrease in VASCEPA sales in the United States.

Previous wording

We recorded U.S. product revenue, net of $43.8 million and $64.6 million during the three months ended June 30, 2024 and 2023, respectively. This decrease was due to a decline in net selling price as a result of the impact from generic competition in the market.

Current wording

We recorded U.S. product revenue, net, of $122.5 million and $209.0 million during the nine months ended September 30, 2024 and 2023, respectively. This decrease was due to a decline in net selling price as a result of the impact from generic competition in the market as well as a decrease in volume primarily related to the loss of a large national PBM, going from exclusive to no longer covering VASCEPA.

Previous wording

The overall icosapent ethyl market in the United States, based on prescription levels reported by Symphony Health, decreased for the six months ended June 30, 2024 by 3% as compared to the six months ended June 30, 2023. Our share of the icosapent ethyl market remained consistent at approximately 57% in both the six months ended June 30, 2024 and 2023. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 1% in the six months ended June 30, 2024 compared to the six months ended June 30, 2023.

Current wording

The overall icosapent ethyl market in the United States, based on prescription levels reported by Symphony Health, decreased for the nine months ended September 30, 2024 by 2% as compared to the nine months ended September 30, 2023. Our share of the icosapent ethyl market has decreased to approximately 55% in the nine months ended September 30, 2024 compared to approximately 57% in the nine months ended September 30, 2023. Additionally, based on prescription levels reported by Symphony Health, VASCEPA-branded prescriptions decreased by 5% in the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023.

Previous wording

For the six months ended June 30, 2024, we recorded $5.4 million of product revenue, net, from our collaboration partners compared to $2.1 million during the six months ended June 30, 2023.

Current wording

For the nine months ended September 30, 2024, we recorded $12.3 million of product revenue, net, from our collaboration partners compared to $3.9 million during the nine months ended September 30, 2023.

Previous wording

Despite the generic competition in the U.S., we remain confident that the global patient need for VASCEPA is high. In 2024, we continue to focus on obtaining pricing reimbursement and launching commercial operations in all remaining European markets as well as progressing regulatory filings and supporting approval processes in up to six countries throughout the rest of the world.

Current wording

Despite the generic competition in the U.S., we remain confident that the global patient need for VASCEPA is high. In 2024, we continue to focus on obtaining pricing reimbursement and launching commercial operations in all remaining European markets as well as supporting our partners to advance access and growing commercial operations throughout the rest of the world.

Previous wording

Licensing and royalty revenue. Licensing and royalty revenue during the six months ended June 30, 2024 and 2023 was $21.3 million and $16.3 million, respectively, an increase of $5.0 million, or 31%. Licensing and royalty revenue increased primarily due to recognition of the REDUCE-IT indication milestone in China, offset by the recognition of CSL upfront payment and recognition of previously achieved milestone payments from HLS in the prior year. Licensing and royalty revenue recognized in the current period relates to the recognition of amounts received in connection with the following VASCEPA licensing agreements:

Current wording

Licensing and royalty revenue. Licensing and royalty revenue during the nine months ended September 30, 2024 and 2023 was $21.8 million and $17.5 million, respectively, an increase of $4.3 million, or 25%. Licensing and royalty revenue increased primarily due to recognition of the REDUCE-IT indication milestone in China, offset by the recognition of CSL and Lotus upfront payments and recognition of previously achieved milestone payments from HLS in the prior year. Licensing and royalty revenue recognized in the current period relates to the recognition of amounts received in connection with the following VASCEPA licensing agreements: