v3.25.1
Development, Commercialization and Supply Agreements
3 Months Ended
Mar. 31, 2025
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Development, Commercialization and Supply Agreements

(8) Development, Commercialization and Supply Agreements

In-licenses

Mochida Pharmaceutical Co., Ltd.

In June 2018, the Company entered into a collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida, related to the development and commercialization of drug products and indications based on the active pharmaceutical ingredient in VASCEPA, the omega-3 acid, EPA, or eicosapentaenoic acid. Among other terms in the agreement, the Company obtained an exclusive license to certain Mochida intellectual property to advance the Company’s interests in the U.S. and certain other territories and the parties will collaborate to research and develop new products and indications based on EPA for the Company’s commercialization in the U.S. and certain other territories. The potential new product and indication opportunities contemplated under this agreement are currently in early stages of development.

Upon closing of the collaboration agreement, the Company made a non-refundable, non-creditable upfront payment of approximately $2.7 million. In addition, the agreement provides for the Company to pay milestone payments upon the achievement of certain product development milestones and royalties on net sales of future products arising from the collaboration, if any.

In February 2025 and January 2024, the Company exercised certain rights under the agreement, resulting in payments of $1.0 million in each of such periods to Mochida, which was recorded as research and development expense in the condensed consolidated statement of operations.

Out-licenses

Eddingpharm (Asia) Macao Commercial Offshore Limited

In February 2015, the Company entered into a Development, Commercialization and Supply Agreement, or the DCS Agreement, with Edding, related to the development and commercialization of VASCEPA in Mainland China, Hong Kong, Macau and Taiwan, or collectively, the China Territory. Under the terms of the DCS Agreement, the Company granted to Edding an exclusive (including as to the Company) license with the right to sublicense development and commercialization of VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company based on the Company’s MARINE, ANCHOR and REDUCE-IT clinical trials of VASCEPA.

Under the DCS Agreement, Edding is solely responsible for development and commercialization activities in the China Territory and associated expenses. The Company provides development assistance and is responsible for supplying finished and later bulk drug product at defined prices under negotiated terms. The Company retains all VASCEPA manufacturing rights. Edding agreed to certain restrictions regarding the commercialization of competitive products globally and the Company agreed to certain restrictions regarding the commercialization of competitive products in the China Territory.

The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, Edding, is a customer. The Company identified the following performance obligations at the inception of the DCS Agreement: (1) the exclusive license to develop and commercialize VASCEPA in the China Territory for uses that are currently commercialized and under development by the Company; (2) the obligation to participate in various steering committees; and (3) ongoing development and regulatory assistance. Based on the analysis performed, the Company concluded that the identified performance obligations are not distinct and therefore a combined performance obligation.

The transaction price is comprised of the following upfront payments and milestones:

In thousands

 

 

 

 

 

Transaction Price Components

 

Achieved

 

Amount

 

Upfront fee

 

February 2015

 

$

15,000

 

Submission of the CTA for the MARINE indication

 

March 2016

 

 

1,000

 

Approval of VASCEPA under the MARINE indication

 

March 2017

 

 

5,000

 

Submission of the CTA for the REDUCE-IT indication

 

October 2023

 

 

3,000

 

Approval of VASCEPA under the REDUCE-IT indication

 

June 2024

 

 

15,000

 

Regulatory Development Support

 

Various

 

 

1,081

 

Total Transaction Price

 

 

 

$

40,081

 

In addition to the non-refundable upfront and regulatory milestone payments described above, the Company is entitled to receive tiered double-digit percentage royalties on net sales of VASCEPA in the China Territory escalating to the high teens. The achievement of sales-based milestone events occur when annual aggregate net sales of VASCEPA in the China Territory equals or exceeds certain specified thresholds, and range from $5.0 million to $50.0 million, for a total of $120.0 million. Each such milestone payment shall be payable only once regardless of how many times the sales milestone event is achieved. Each such milestone payment is non-refundable and non-creditable against any other milestone payments.

None of the other clinical or regulatory milestones has been included in the transaction price, as all milestone amounts are fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones, including royalties, will be recognized when the related sales occur and therefore have also been excluded from the transaction price. The Company will reevaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

The Company fully recognized the transaction price as of June 30, 2024.

In thousands

 

Amount

 

Licensing revenue recognized during the three months ended March 31, 2025 (1)

 

$

 

Licensing revenue recognized during the three months ended March 31, 2024 (1)

 

 

376

 

Licensing revenue recognized from contract inception through both March 31, 2025 and December 31, 2024

 

$

40,081

 

(1)
Licensing revenue under the DCS Agreement is recognized concurrent with the input measure of support hours provided by Amarin to Edding in achieving the combined development and regulatory performance obligation, which in the Company’s judgment is the best measure of progress towards satisfying this performance obligation.

The Company recognized net product revenue of nil and $3.4 million for the three months ended March 31, 2025 and 2024, respectively, related to sales to Edding.

Biologix FZCo

In March 2016, the Company entered into an agreement with Biologix FZCo, or Biologix, a company incorporated under the laws of the United Arab Emirates, to register and commercialize VASCEPA in several Middle Eastern and North African countries. Under the terms of the distribution agreement, the Company granted to Biologix a non-exclusive license to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Middle East and North Africa territory. Upon closing of the agreement, the Company received a non-refundable upfront payment, which has been fully recognized as of June 30, 2024. The Company is entitled to receive all payments based on total product sales and pays Biologix a service fee in exchange for its services, whereby the service fee represents a percentage of gross selling price which is subject to a minimum floor price.

The Company received approval of VASCEPA under the MARINE and REDUCE-IT indications in the following countries:

Country

 

MARINE

 

REDUCE-IT

 

Launch Date

Lebanon

 

March 2018

 

August 2021

 

June 2018

United Arab Emirates

 

July 2018

 

October 2021

 

February 2019

Qatar

 

December 2019

 

April 2021

 

May 2022

Bahrain

 

April 2021

 

April 2022

 

September 2023

Kuwait

 

December 2021

 

March 2023

 

September 2023

Saudi Arabia

 

March 2022

 

June 2023

 

September 2023

The Company recognized less than $0.1 million of net product revenue for the three months ended March 31, 2025 and nil for the three months ended March 31, 2024 related to sales to Biologix.

HLS Therapeutics, Inc.

In September 2017, the Company entered into an agreement with HLS Therapeutics, Inc., or HLS, a company incorporated under the laws of Canada, to register, commercialize and distribute VASCEPA in Canada. Under the agreement, HLS is responsible for regulatory and commercialization activities and associated costs. The Company is responsible for providing assistance towards local filings, supplying finished product under negotiated supply terms, maintaining intellectual property, and continuing the development and funding of REDUCE-IT related activities.

The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, HLS, is a customer. The Company identified the following performance obligations at the inception of the contract: (1) license to HLS to develop, register, and commercialize VASCEPA in Canada; (2) support general development and regulatory activities; and (3) participate in various steering committees. Based on the analysis performed, the Company concluded that the identified performance obligations in the agreement are not distinct and therefore a combined performance obligation.

The transaction price is comprised of the following upfront payments and milestones:

In thousands

 

 

 

 

 

Transaction Price Components

 

Achieved

 

Amount

 

Upfront fee

 

September 2017

 

$

5,000

 

Achievement of the REDUCE-IT trial primary endpoint

 

September 2018

 

 

2,500

 

Approval from Health Canada

 

December 2019

 

 

2,500

 

Regulatory exclusivity from the Office of Patented Medicines and Liaison

 

January 2020

 

 

3,800

 

Total Transaction Price

 

 

 

$

13,800

 

In addition to the non-refundable upfront and regulatory milestone payments just described, the Company is entitled to receive certain sales-based milestone payments of up to an additional $50.0 million, as well as tiered double-digit royalties on net sales of VASCEPA in Canada. None of the other clinical or regulatory milestones has been included in the transaction price, as all milestone amounts are fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and the licensee’s efforts. Any consideration related to sales-based milestones (including royalties) will be recognized when the related sales occur and therefore have also been excluded from the transaction price.

The Company fully recognized the transaction price as of June 30, 2023.

The Company recognized net product revenue of nil and $1.9 million for the three months ended March 31, 2025 and 2024, respectively, related to sales to HLS.

CSL Seqirus

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. The Company received an upfront payment of $0.5 million, which was fully recognized during the first quarter of 2023. In October 2024, CSL obtained listing of VAZKEPA on the Pharmaceutical Benefits Scheme, or PBS, in Australia, as a result the Company received a non-refundable $1.2 million milestone payment. In addition to the upfront payment, the Company will be eligible to receive event-related milestone payments of approximately $6.0 million and additional product-related milestone payments of approximately $4.0 million. The Company will be responsible for supplying finished product to CSL Seqirus at a price that is the greater of (i) a fixed transfer price, or (ii) a fixed percentage of the net selling price, as defined in the CSL agreement.

The Company assessed this arrangement in accordance with Topic 606 and concluded that the contract counterparty, CSL, is a customer. The Company identified the following distinct performance obligations at the inception of the contract: an exclusive license

to use its trademarks in connection with the importation, distribution, promotion, marketing and sale of VASCEPA in the Australia and New Zealand territories.

The transaction price includes the $0.5 million upfront consideration as well as the $1.2 million milestone payment received related to the listing of VAZKEPA on the PBS in Australia.. Any consideration related to event-based or product-based milestones will be recognized when the related milestone events occur and therefore have also been excluded from the transaction price. The Company will reevaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

The Company did not recognize any licensing revenue in connection with the CSL agreement during the three months ended March 31, 2025 and 2024.

The Company did not recognize net product revenue related to sales to CSL during the three months ended March 31, 2025 and 2024.

The following table presents changes in the balances of the Company’s contract assets and liabilities during the three months ended March 31, 2025 and 2024:

In thousands

Balance at Beginning of Period

 

 

Additions

 

 

Deductions

 

 

Balance at
End of Period

 

Three months ended March 31, 2025:

 

 

 

 

 

 

 

 

 

 

 

Contract assets

$

 

 

$

 

 

$

 

 

$

 

Contract liabilities:

 

 

 

 

 

 

 

 

 

 

 

Deferred revenue

$

 

 

$

 

 

$

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended March 31, 2024:

 

 

 

 

 

 

 

 

 

 

 

Contract assets

$

 

 

$

 

 

$

 

 

$

 

Contract liabilities:

 

 

 

 

 

 

 

 

 

 

 

Deferred revenue

$

4,850

 

 

$

 

 

$

(401

)

 

$

4,449

 

During the three months ended March 31, 2025 and 2024, the Company recognized the following revenues as a result of changes in the contract asset and contract liability balances in the respective periods:

In thousands

Three months ended March 31,

 

Revenue recognized in the period from:

2025

 

 

2024

 

Amounts included in contract liability at the beginning of the period

$

 

 

$

401