v3.26.1
License and Collaboration Agreements
6 Months Ended
Jun. 30, 2026
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
License and Collaboration Agreements

10. License and Collaboration Agreements

License and Collaboration Revenues

As of June 30, 2026, the Company’s NAV Technology Platform was being applied by NAV Technology Licensees in two commercial products, Zolgensma and Itvisma, and in the development of various other licensed products. Additionally, the Company has licensed intellectual property rights to collaborators for the joint development and commercialization of certain product candidates. Consideration payable to the Company under its license and collaboration agreements may include: (i) up-front and annual fees, (ii) milestone payments based on the achievement of certain development and sales-based milestones, (iii) sublicense fees, (iv) royalties on sales of licensed products, (v) fees for services related to the development and manufacturing of licensed products and (vi) other consideration payable upon optional goods and services purchased by licensees and collaborators. Sublicense fees vary by license and range from a mid-single digit percentage to a low-double digit percentage of license fees received by licensees as a result of sublicenses. Royalties on net sales of commercialized products vary by license and range from a mid-single digit percentage to a low double-digit percentage of net sales by licensees.

Revenues earned under license and collaboration agreements consisted of the following (in thousands):

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

License and royalty revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Zolgensma and Itvisma royalties

 

$

3,841

 

 

$

18,423

 

 

$

8,893

 

 

$

35,416

 

AbbVie development milestone

 

 

100,000

 

 

 

 

 

 

100,000

 

 

 

 

Nippon Shinyaku licenses

 

 

 

 

 

 

 

 

 

 

 

69,979

 

Other

 

 

 

 

 

42

 

 

 

38

 

 

 

119

 

Total license and royalty revenue

 

 

103,841

 

 

 

18,465

 

 

 

108,931

 

 

 

105,514

 

Service revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Nippon Shinyaku services

 

 

3,720

 

 

 

2,720

 

 

 

4,731

 

 

 

4,494

 

Other

 

 

458

 

 

 

174

 

 

 

750

 

 

 

363

 

Total service revenue

 

 

4,178

 

 

 

2,894

 

 

 

5,481

 

 

 

4,857

 

Total revenues

 

$

108,019

 

 

$

21,359

 

 

$

114,412

 

 

$

110,371

 

 

Outstanding development milestone payments are evaluated each reporting period and are only included in the transaction price of each license to the extent the milestones are considered probable of achievement. Sales-based milestones are excluded from the transaction price of each license agreement and recognized as royalty revenue in the period of achievement. As of June 30, 2026, the Company’s license and collaboration agreements contained unachieved milestones which could result in aggregate milestone payments to the Company of up to $2.06 billion, including (i) $444.0 million upon the commencement of various stages of clinical trials, (ii) $86.5 million upon the submission of regulatory approval filings or upon regulatory approval of licensed products, and (iii) $1.53 billion upon the achievement of specified sales targets for licensed products, including milestones payable upon the first commercial sale of licensed products. To the extent the Company realizes the milestone payments, the Company may be obligated to pay sublicense fees to licensors based on a specified percentage of the fees earned by the Company. The achievement of these milestones is highly dependent on the successful development and commercialization of licensed products and it is at least reasonably possible that some or all of the milestone fees will not be realized by the Company.

Accounts Receivable, Contract Assets and Deferred Revenue

The following table presents the balances of the Company’s accounts receivable, contract assets and deferred revenue, as well as other information regarding revenue recognized, during the periods presented (in thousands):

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Accounts receivable, current and non-current:

 

 

 

 

 

 

 

 

 

 

 

 

Beginning of period

 

$

10,458

 

 

$

19,400

 

 

$

28,691

 

 

$

20,947

 

End of period

 

$

107,189

 

 

$

21,783

 

 

$

107,189

 

 

$

21,783

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contract assets (included in other current assets):

 

 

 

 

 

 

 

 

 

 

 

 

Beginning of period

 

$

65

 

 

$

44

 

 

$

104

 

 

$

239

 

End of period

 

$

523

 

 

$

28

 

 

$

523

 

 

$

28

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Deferred revenue, current and non-current:

 

 

 

 

 

 

 

 

 

 

 

 

Beginning of period

 

$

28,695

 

 

$

39,885

 

 

$

29,395

 

 

$

115

 

End of period

 

$

25,286

 

 

$

37,781

 

 

$

25,286

 

 

$

37,781

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue recognized during the period from:

 

 

 

 

 

 

 

 

 

 

 

 

Amounts included in deferred revenue at beginning of period

 

$

3,409

 

 

$

2,104

 

 

$

4,109

 

 

$

115

 

Performance obligations satisfied in previous periods

 

$

105,793

 

 

$

18,425

 

 

$

110,808

 

 

$

35,420

 

 

Revenue recognized from performance obligations satisfied in previous periods, as presented in the table above, was primarily attributable to Zolgensma and Itvisma royalties and changes in the transaction prices of the Company’s license agreements. Changes in transaction prices were primarily attributable to the achievement of development milestones, or the resolution of related uncertainties such that it became probable that a significant reversal of cumulative revenue would not occur if the development milestone consideration was included in the transaction price. These changes were recognized as cumulative catch-up adjustments to revenue. Revenue recognized during the three and six months ended June 30, 2026 included $100.0 million in cumulative catch-up adjustments for changes in the probability of achievement of development milestones, which was associated with a $100.0 million development milestone achieved under the Company's collaboration and license agreement with AbbVie. No cumulative catch-up adjustments for development milestones were recorded in revenue during the three and six months ended June 30, 2025.

As of June 30, 2026, the Company had recorded deferred revenue of $25.3 million which represents consideration received or unconditionally due from licensees and collaboration partners for performance obligations that have not yet been satisfied by the Company. Unsatisfied performance obligations as of June 30, 2026 consisted of (i) development services to be performed related to licensed products, which will be satisfied as the services are performed, and (ii) material rights granted to purchase commercial supply of licensed products, which will be satisfied upon delivery of the commercial supply. As of June 30, 2026, the aggregate transaction price of the Company’s license and collaboration agreements allocated to performance obligations not yet satisfied or partially satisfied was $27.4 million, primarily associated with development services under the Company's collaboration and license agreement with Nippon Shinyaku, the substantial majority of which is expected to be satisfied over a period of approximately five years.

Accounts receivable consisted of the following (in thousands):

 

 

 

June 30, 2026

 

 

December 31, 2025

 

Current accounts receivable:

 

 

 

 

 

 

Billed to AbbVie for development milestone

 

$

100,000

 

 

$

 

Billed to other customers

 

 

385

 

 

 

557

 

Unbilled Novartis royalties

 

 

4,124

 

 

 

23,806

 

Unbilled Nippon Shinyaku services

 

 

2,222

 

 

 

1,997

 

Other unbilled

 

 

23

 

 

 

19

 

Current accounts receivable

 

 

106,754

 

 

 

26,379

 

Non-current accounts receivable:

 

 

 

 

 

 

Unbilled Nippon Shinyaku services

 

 

 

 

 

1,858

 

Other unbilled

 

 

435

 

 

 

454

 

Non-current accounts receivable

 

 

435

 

 

 

2,312

 

Total accounts receivable

 

$

107,189

 

 

$

28,691

 

 

Zolgensma and Itvisma License with Novartis

In March 2014, the Company entered into an exclusive license agreement (as amended, the Novartis License) with Novartis Innovative Technologies Inc. (formerly, Novartis Gene Therapies, Inc.), a wholly owned subsidiary of Novartis AG (Novartis). Under the Novartis License, the Company granted Novartis an exclusive, worldwide commercial license, with rights to sublicense, to the NAV Technology Platform, as well as other certain rights, for the treatment of spinal muscular atrophy (SMA) in humans by in vivo gene therapy. In 2019, Novartis launched commercial sales of Zolgensma for the treatment of SMA in patients under the age of two years old. In the fourth quarter of 2025, Novartis launched commercial sales of Itvisma for the treatment of SMA in patients two years and older. Zolgensma and Itvisma are licensed products under the Novartis License, pursuant to which the Company receives royalties on certain net sales of the licensed products.

In January 2026, licensed patents for Zolgensma under the Novartis License expired in the United States. The Company is entitled to continued royalties on net sales of Zolgensma in approximately 20 countries where licensed patents remain active. Licensed product made prior to patent expiration but sold after expiration may also be subject to royalties. Licensed patents covering the use of Itvisma have issued in the United States and certain other countries, and the Company is entitled to ongoing royalties on certain net sales of Itvisma in these territories.

The Company recognized the following amounts under the Novartis License (in thousands):

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

Zolgensma royalties

 

$

1,753

 

 

$

18,423

 

 

$

6,502

 

 

$

35,416

 

Itvisma royalties

 

 

2,088

 

 

 

 

 

 

2,391

 

 

 

 

Total license and royalty revenue

 

$

3,841

 

 

$

18,423

 

 

$

8,893

 

 

$

35,416

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income from licensing

 

$

10

 

 

$

10

 

 

$

20

 

 

$

21

 

 

As of June 30, 2026 and December 31, 2025, the Company had recorded total accounts receivable of $4.4 million and $24.1 million, respectively, from Novartis under the Novartis License, which consisted primarily of Zolgensma and Itvisma royalties receivable. Royalties receivable as of June 30, 2026 included $3.3 million expected to be paid to HCR in accordance with the 2020 Royalty Purchase Agreement discussed in Note 7. The Company recognizes royalty revenue from net sales of Zolgensma and Itvisma in the period in which the underlying products are sold by Novartis, which in certain cases may require the Company to estimate royalty revenue for periods of net sales which have not yet been reported to the Company. Estimated royalties are reconciled to actual amounts reported in subsequent periods, and any differences are recognized as an adjustment to royalty revenue in the period the royalties are reported.

Collaboration Agreements

AbbVie Collaboration and License Agreement

In September 2021, the Company entered into a collaboration and license agreement with AbbVie to jointly develop and commercialize sura-vec (or ABBV-RGX-314), the Company’s product candidate for the treatment of wet AMD, DR and other chronic retinal diseases (as amended, the AbbVie Collaboration Agreement). The AbbVie Collaboration Agreement became effective in November 2021.

Pursuant to the AbbVie Collaboration Agreement, the Company granted AbbVie a co-exclusive license to develop and commercialize sura-vec in the United States and an exclusive license to develop and commercialize sura-vec outside the United States. The Company and AbbVie will collaborate to develop sura-vec in the United States, and AbbVie will be responsible for the development of sura-vec in specified markets outside the United States. Global development expenses for sura-vec are shared by the parties in accordance with the AbbVie Collaboration Agreement, with AbbVie being responsible for the majority of total development expenses.

The Company will lead the manufacturing of sura-vec for clinical development and U.S. commercial supply, and AbbVie will lead the manufacturing of sura-vec for commercial supply outside the United States. Manufacturing expenses will be allocated between the parties in accordance with the terms of the AbbVie Collaboration Agreement and mutually agreed supply agreements. If requested by AbbVie, the Company will manufacture up to a specified portion of sura-vec commercial supply for sales outside the United States at a price specified in the agreement. AbbVie will lead the commercialization of sura-vec globally, and the Company will participate in U.S. commercialization efforts as provided under a commercialization plan determined in accordance with the

agreement. The Company and AbbVie will share equally in the net profits and net losses associated with the commercialization of sura-vec in the United States. Outside the United States, AbbVie will be responsible, at its sole cost, for the commercialization of sura-vec.

In consideration for the rights granted under the AbbVie Collaboration Agreement, AbbVie paid the Company an up-front fee of $370.0 million upon the effective date of the agreement in November 2021 and is required to pay to the Company up to $1.38 billion upon the achievement of specified development and sales-based milestones, of which $562.5 million are based on development milestones and $820.0 million are sales-based milestones. AbbVie is also required to pay to the Company tiered royalties on net sales of sura-vec outside the United States at percentages in the mid-teens to low twenties, subject to specified offsets and reductions.

In August 2025, the Company and AbbVie entered into an amendment to the AbbVie Collaboration Agreement which modified the development plan and milestone payment structure for the sura-vec DR program. Under the amendment, the Company will conduct the first registration enabling trial for DR suprachoroidal (SCS) treatment as a combined Phase IIb/III trial (NAAVIGATE) which will be performed in two parts (Part 1 and Part 2), and AbbVie will conduct the second registration enabling trial as a separate, standalone Phase III trial. In lieu of a $200.0 million development milestone payable to the Company under the original AbbVie Collaboration Agreement upon first patient dosed in the first registration enabling trial for DR SCS treatment, AbbVie will pay the Company $100.0 million upon first patient dosed in the NAAVIGATE trial (the First DR Milestone) and an additional $100.0 million upon first patient dosed in the subsequent Phase III trial (the Second DR Milestone). Also pursuant to the amendment, AbbVie will lead a new Phase III randomized controlled study (ACHIEVE) to assess the injection burden, adverse events, change in disease activity, and long-term preservation of visual acuity of sura-vec in adult participants with neovascular AMD. The Company will be responsible for its development expenses to conduct Part 1 of the NAAVIGATE trial and the parties will share the development expenses related to Part 2 of the NAAVIGATE trial and the subsequent Phase III trial for DR in accordance with the existing terms of the AbbVie Collaboration Agreement. AbbVie will be responsible for all development expenses related to the ACHIEVE study.

In June 2026, the Company dosed the first patient in the NAAVIGATE trial, resulting in a $100.0 million milestone payment due from AbbVie for achievement of the First DR Milestone. The $100.0 million milestone payment was recorded as accounts receivable as of June 30, 2026 and was received from AbbVie in July 2026.

The Company applied the requirements of ASC 606, Revenue from Contracts with Customers (ASC 606) to the AbbVie Collaboration Agreement for the units of account in which AbbVie was deemed to be a customer. The Company determined that there is only one material performance obligation under the agreement for the delivery of the intellectual property license to develop and commercialize sura-vec globally. The intellectual property licensed to AbbVie includes the rights to certain patents, data, know-how and other rights developed and owned by the Company, as well as other intellectual property rights exclusively licensed by the Company from various third parties. As of June 30, 2026, the transaction price of the AbbVie Collaboration Agreement was $470.0 million, which consisted of (i) the $370.0 up-front payment received from AbbVie in November 2021 and (ii) the $100.0 million development milestone payment earned upon achievement of the First DR Milestone in June 2026, which was received from AbbVie in July 2026. As of June 30, 2026, variable consideration excluded from the transaction price of the AbbVie Collaboration Agreement includes $462.5 million in payments for development milestones that have not yet been achieved and were not considered probable of achievement. Additionally, the transaction price excludes sales-based milestone payments of $820.0 million and royalties on net sales of sura-vec outside the United States. Development milestones will be added to the transaction price and recognized as revenue upon achievement, or if deemed probable of achievement. In accordance with the sale- or usage-based royalty exception under ASC 606, royalties on net sales and sales-based milestones will be recognized as revenue in the period the underlying sales occur or milestones are achieved. The $470.0 million transaction price of the AbbVie Collaboration Agreement has been fully recognized as license and royalty revenue since the intellectual property licenses were delivered to AbbVie at the inception of the agreement in November 2021. The transaction price of the AbbVie Collaboration Agreement increased by $100.0 million during the three and six months ended June 30, 2026 as a result of the achievement of the First DR Milestone in June 2026, as the milestone payment was previously constrained and excluded from the transaction price. The $100.0 million increase in the transaction price was fully recognized as a cumulative catch-up adjustment to revenue upon the achievement of the First DR Milestone in June 2026. There were no changes in the transaction price of the AbbVie Collaboration Agreement, and no revenue was recognized, during the three and six months ended June 30, 2025.

The Company applied the requirements of ASC 808, Collaborative Arrangements (ASC 808) to the AbbVie Collaboration Agreement for the units of account which were deemed to be a collaborative arrangement. Both the Company and AbbVie will perform various activities related to the development, manufacturing and commercialization of sura-vec in the United States. Development costs are shared between the parties in accordance with the terms of the AbbVie Collaboration Agreement, and the parties will share equally in the net profits and losses derived from sales of sura-vec in the United States. The Company accounts for payments to and from AbbVie for the sharing of development and commercialization costs in accordance with its accounting policy for collaborative arrangements. Amounts owed to AbbVie for the Company’s share of development costs or commercialization costs incurred by AbbVie are recorded as research and development expense or general and administrative expense, respectively, in the

period the costs are incurred. Amounts owed to the Company for AbbVie’s share of development costs or commercialization costs incurred by the Company are recorded as a reduction of research and development expense or general and administrative expense, respectively, in the period the costs are incurred. At the end of each reporting period, the Company records a net amount due to or from AbbVie as a result of the cost-sharing arrangement. As of June 30, 2026 and December 31, 2025, the Company had recorded $10.5 million and $10.9 million, respectively, due from AbbVie for net reimbursement of costs incurred for activities performed under the AbbVie Collaboration Agreement, which was included in other current assets on the consolidated balance sheets.

The Company recognized the following amounts under the AbbVie Collaboration Agreement (in thousands):

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

License and royalty revenue

 

$

100,000

 

 

$

 

 

$

100,000

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net cost reimbursement to (from) AbbVie included in:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expense

 

$

(12,051

)

 

$

(17,056

)

 

$

(24,686

)

 

$

(31,737

)

General and administrative expense

 

 

1,231

 

 

 

551

 

 

 

1,751

 

 

 

1,148

 

Total net cost reimbursement to (from) AbbVie

 

$

(10,820

)

 

$

(16,505

)

 

$

(22,935

)

 

$

(30,589

)

Nippon Shinyaku Collaboration and License Agreement

In January 2025, the Company entered into a collaboration and license agreement with Nippon Shinyaku for the development and commercialization of RGX-121, the Company’s product candidate for the treatment of MPS II, and RGX-111, the Company's product candidate for the treatment of MPS I (the Nippon Shinyaku Collaboration Agreement). The Nippon Shinyaku Collaboration Agreement became effective in March 2025.

Pursuant to the Nippon Shinyaku Collaboration Agreement, the Company granted Nippon Shinyaku a license to develop and exclusively commercialize RGX-121 and RGX-111 in the United States and certain countries in Asia. The Company is responsible for the development of RGX-121 and RGX-111 in the United States, and Nippon Shinyaku is responsible for development in licensed territories outside the United States. The Company is responsible for the manufacturing of RGX-121 and RGX-111 for clinical development and commercial supply, and manufacturing expenses will be allocated between the parties in accordance with the terms of the Nippon Shinyaku Collaboration Agreement and mutually agreed supply agreements. Nippon Shinyaku will be responsible, at its sole cost, for the commercialization of RGX-121 and RGX-111 in the licensed territories. The Company reserves the right to develop and commercialize RGX-121 and RGX-111 in countries outside the licensed territories.

In consideration for the rights granted and services to be performed under the Nippon Shinyaku Collaboration Agreement, Nippon Shinyaku paid the Company an up-front fee of $110.0 million upon the effective date of the agreement in March 2025 and is required to pay to the Company up to $700.0 million upon the achievement of specified development and sales-based milestones, of which $40.0 million are based on development milestones and $660.0 million are sales-based milestones. Nippon Shinyaku is also required to pay to the Company double-digit royalties on net sales of RGX-121 and RGX-111 in the licensed territories, subject to specified offsets and reductions. The Company retains all rights to, and any proceeds related to the sale of, any priority review vouchers that may be issued upon the potential approvals of RGX-121 and RGX-111.

The Company concluded that each of the distinct units of account identified under the Nippon Shinyaku Collaboration Agreement should be accounted for as revenue under ASC 606, as Nippon Shinyaku is deemed to be a customer for each of the various transactions. The Company identified the following material performance obligations under the agreement: (i) delivery of intellectual property licenses to develop and commercialize RGX-121 and RGX-111 in the United States and Asia territories, (ii) development services for RGX-121 and RGX-111 in the United States, including manufacturing of clinical supply and commercial supply prior to regulatory approval, and (iii) material rights granted to Nippon Shinyaku to purchase commercial supply for sales in licensed territories.

As of June 30, 2026, the transaction price of the Nippon Shinyaku Collaboration Agreement included fixed consideration of $110.0 million for the up-front payment and estimated variable consideration of $6.2 million for reimbursable costs of manufacturing and other services which are deemed not to be constrained. Variable consideration which has been excluded from the transaction price includes $40.0 million in payments for development milestones that have not yet been achieved and were not considered probable of achievement, and reimbursable costs of manufacturing and other services which are contingent on events occurring that are outside the Company’s control and are deemed to be constrained. The transaction price also excludes sales-based milestone payments of $660.0

million and royalties on net sales of RGX-121 and RGX-111 in the United States and Asia territories. Development milestones will be added to the transaction price upon achievement, or if deemed probable of achievement, and other variable consideration for manufacturing and other services may be added to the transaction price in the future as uncertainties regarding payment of the consideration are resolved. In accordance with the sale- or usage-based royalty exception under ASC 606, royalties on net sales and sales-based milestones will be recognized as revenue in the period the underlying sales occur or milestones are achieved. There were no changes in the fixed transaction price of the Nippon Shinyaku Collaboration Agreement during the three and six months ended June 30, 2026 and 2025.

The fixed transaction price of the Nippon Shinyaku Collaboration Agreement of $110.0 million was allocated to the various performance obligations based on their relative standalone selling prices, which requires significant judgment. The $6.2 million of estimated variable consideration included in the transaction price is allocated directly to performance obligations for the manufacturing of commercial supply prior to regulatory approval and other service obligations since the consideration is directly associated with the performance of such services and reimbursement of applicable costs. Consideration contingent upon the future exercise of options to purchase commercial supply is excluded from the transaction price until exercised.

The portion of the $110.0 million fixed transaction price allocated to the delivery of the intellectual property licenses was recognized as license and royalty revenue upon the delivery of the licenses to Nippon Shinyaku in March 2025. The portion of the fixed transaction price allocated to development services will be recognized as service revenue as the services are performed using an input method based on costs incurred versus total estimated costs to perform the services, which is re-assessed at each reporting date. The portion of the fixed transaction price allocated to material rights to purchase commercial supply will be recognized as revenue proportionally with the total expected commercial supply revenue expected to be recognized under the arrangement, which is re-assessed at each reporting date. Commercial supply revenue will be recognized as revenue upon delivery to Nippon Shinyaku, or otherwise upon transfer of control of commercial supply to Nippon Shinyaku as defined in the associated supply agreements.

The Company recognized the following amounts under the Nippon Shinyaku Collaboration Agreement (in thousands):

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2026

 

 

2025

 

 

2026

 

 

2025

 

License and royalty revenue

 

$

 

 

$

 

 

$

 

 

$

69,979

 

Service revenue

 

 

3,720

 

 

 

2,720

 

 

 

4,731

 

 

 

4,494

 

Total revenues

 

$

3,720

 

 

$

2,720

 

 

$

4,731

 

 

$

74,473

 

As of June 30, 2026 and December 31, 2025, the Company had recorded total accounts receivable of $2.5 million and $4.1 million, respectively, for reimbursement of manufacturing-related development costs and other services under the Nippon Shinyaku Collaboration Agreement.

As of June 30, 2026, the Company had recorded total deferred revenue of $25.3 million for development services and material rights which have not yet been satisfied under the Nippon Shinyaku Collaboration Agreement, of which $9.9 million was included in current liabilities and $15.4 million was included in non-current liabilities. As of December 31, 2025, the Company had recorded total deferred revenue of $29.4 million for development services and material rights which have not yet been satisfied under the Nippon Shinyaku Collaboration Agreement, of which $10.5 million was included in current liabilities and $18.9 million was included in non-current liabilities.