v3.26.3
Alliance and Collaboration
9 Months Ended
Sep. 30, 2026
Business Combination, Asset Acquisition, Transaction between Entities under Common Control, and Joint Venture Formation [Abstract]  
Alliance and Collaboration Alliance and Collaboration
The Company has entered into several alliance, collaboration, license, distribution and similar agreements with respect to certain of its products and services with third-party pharmaceutical companies. The consolidated statements of operations include revenue recognized under agreements the Company has entered into to develop marketing and/or distribution relationships with its partners to fully leverage the technology platform and revenue recognized under development agreements. These agreements generally obligate the Company to provide R&D services over multiple periods.
Except as disclosed below, as of and for the three and nine months ended September 30, 2026, there were no material changes to our alliance and collaboration agreements as described and defined in Note 4. Alliance and Collaboration in the Company’s 2025 Annual Report on Form 10-K.
The following table summarizes certain amounts recognized in the Company’s consolidated statements of operations related to alliance and collaboration agreements for the three and nine months ended September 30, 2026 and 2025 (in thousands):
Three Months Ended September 30,Nine Months Ended September 30,
PartyCaption in Statement of Operations2026202520262025
Orion Corporation
Research and development (1)
$(776)$(912)$(1,883)$(2,677)
Orion Corporation
Research and development (2)
$(197)$(372)$(818)$(1,131)
Pfizer Inc. (formerly Metsera, Inc.)
Other operating income (3)
$— $— $(6,877)$— 
Pfizer Inc. (formerly Metsera, Inc.)
Net revenue (4)
$— $245 $— $2,218 
Zambon Biotech S.A.
Net revenue (5)
$1,488 $— $1,488 $— 
(1)Deferred income was recognized as a reduction to R&D expense as services were performed under the Orion Agreement.
(2)Reimbursable R&D services performed under the Orion Agreement were recorded as a reduction to R&D expense.
(3)Gain from derecognizing financing obligation (refer to the Pfizer Collaboration Agreement section below).
(4)Development activities performed on behalf of Pfizer, Inc. on a cost plus margin basis are recorded as net revenue.
(5)Net revenue was recognized for achievement of a regulatory approval milestone.
The following table summarizes certain balances recognized in the Company’s consolidated balance sheets related to alliance and collaboration agreements as of September 30, 2026 and December 31, 2025 (in thousands):
PartyCaption in Balance SheetSeptember 30, 2026December 31, 2025
Orion Corporation
Accounts payable and accrued expenses (1)
$3,445 $4,811 
Orion Corporation
Other long-term liabilities (1)
$296 $814 
Zambon Biotech S.A.
Other long-term liabilities (1)
$2,725 $2,530 
Zambon Biotech S.A.
Accounts payable and accrued expenses (1)
$641 $— 
mAbxience S.L.
Accounts payable and accrued expenses (2)
$— $7,500 
Pfizer Inc. (formerly Metsera, Inc.)
Prepaid expenses and other current assets (3)
$— $321 
Pfizer Inc. (formerly Metsera, Inc.)
Other long-term liabilities (4)
$22,415 $9,378 
(1)Comprised of deferred income as of September 30, 2026 and December 31, 2025.
(2)Comprised of an accrued milestone as of December 31, 2025 for a Food and Drug Administration (“FDA”) approval.
(3)Comprised primarily of unbilled receivables for R&D services performed as of December 31, 2025.
(4)Comprised of construction costs contributed, as defined in the Company’s collaboration agreement with Pfizer Inc. (“Pfizer”). As of September 30, 2026, the funding received from Pfizer represented a contract obligation for future manufacturing services (deferred income). As of December 31, 2025, the funding received from Pfizer was allocated between two performance obligations: (i) a financing obligation in accordance with ASC 470, Debt of $6.4 million and (ii) a contract obligation for future manufacturing services of $3.0 million (refer to the Pfizer Collaboration Agreement section below).
New Developments in 2026
Pfizer Collaboration Agreement
On November 13, 2025, Metsera, Inc. (“Metsera”) was acquired by Pfizer. On January 30, 2026, Pfizer exercised its rights under the change-in-control provision in the Metsera collaboration agreement with the Company to shorten the agreement’s term from seven years to four years from the date of first commercial sale. As a result, the Company’s rebate and construction cost reimbursement obligations to Pfizer have been eliminated. Pfizer’s cost sharing commitment of up to $100 million for construction costs and all other terms of the agreement remain unchanged.
In connection with the notice from Pfizer, the Company recognized a gain of $6.9 million in other operating income for the nine months ended September 30, 2026 to derecognize the financing obligation previously recognized in accordance with ASC 470, Debt through the date of the notice. The Company will classify all future proceeds received from Pfizer for construction costs contributed as a contract obligation for future manufacturing services (recorded as deferred income within other long‑term liabilities on the consolidated balance sheet). As of September 30, 2026, no commercial products have been launched under this collaboration agreement. Refer to Note 15. Other Long-Term Liabilities for additional information.
MSN Laboratories Private Limited Supply and Distribution Agreement
On April 2, 2026, the Company entered into a supply and distribution agreement with MSN Laboratories Private Limited (“MSN”) for the exclusive distribution of generic mirabegron extended‑release tablets in the United States and its territories (the “MSN agreement”). Mirabegron is a generic, AB-rated version of the reference listed drug, Myrbetriq®. In connection with the MSN agreement, the Company made an upfront cash payment of $75.0 million in April 2026, which was capitalized as a product rights intangible asset and is being amortized to cost of sales over its estimated useful life of five years following the commercial launch of the product in the second quarter of 2026. Additionally, the Company will pay a per‑unit fee and profit‑sharing to MSN based on product sales. MSN is responsible for the commercial manufacture and supply of the finished product and the Company is responsible for the marketing, promotion, and sale of the product.
Adalvo License and Supply Agreement – Tirzepatide
On May 13, 2026, the Company entered into a License and Supply Agreement with Adalvo to develop, register and commercialize two generic tirzepatide products in the U.S. Pursuant to the agreement, the Company received exclusive rights to Adalvo’s regulatory dossiers and related intellectual property for use in obtaining U.S. regulatory approvals for the products. The Company is responsible for regulatory filings, commercialization and distribution, while Adalvo is responsible for development, manufacturing and supply of the products. The agreement provides for development, regulatory and commercial milestone payments of up to $21.0 million, including payments upon regulatory submissions and acceptance, regulatory approvals, product launches and achievement of a specified cumulative net sales threshold. The Company will share a portion of net profits from product sales with Adalvo, after deduction of agreed-upon costs, pursuant to the terms of the agreement. Profit share amounts are calculated and settled on a quarterly basis.
During the nine months ended September 30, 2026, the Company recorded $3.0 million of R&D expense related to the achievement of regulatory milestones under the agreement (submission of an Abbreviated New Drug Application (“ANDA”) and subsequent acceptance by the FDA) for each product.
mAbxience Biosimilar Licensing and Supply Agreement – Denosumab
On May 26, 2026, the Company entered into a supply agreement with mAbxience S.L. (“mAbxience”) to establish supply pricing for Boncresa® and Oziltus® (denosumab biosimilars referencing Prolia® and XGEVA®, respectively). The supply agreement is an addition to the Company’s existing licensing arrangement with mAbxience dated October 12, 2023, as previously described in Note 4. Alliance and Collaboration in the Company’s 2025 Annual Report on Form 10-K.
In connection with the execution of the supply agreement, the Company incurred a one-time signing fee of $6.0 million payable to mAbxience, which was capitalized as an intangible asset during the three months ended June 30, 2026. The signing fee was paid during the three months ended September 30, 2026. The intangible asset will be amortized to cost of sales over its estimated useful life of five years, with amortization commencing upon commercial launch of the products.
Alvotech hf. License Agreement
In connection with the closing of the Kashiv Acquisition on August 10, 2026, the Company acquired a product licensing and supply agreement with Alvotech hf. (“Alvotech”) pursuant to which Alvotech has exclusive rights to obtain regulatory approval for and commercialize a biosimilar to XOLAIR® (omalizumab) in the European Union, the United Kingdom, Australia, Canada
and New Zealand. Under the agreement, the Company is responsible for certain R&D activities and dossier-related support, while Alvotech is responsible for regulatory approval, commercialization, marketing and sales activities within the licensed territories. The agreement provides for potential future development, regulatory and commercial milestone payments of up to $25.0 million and royalties based on net sales of the licensed product, subject to specified deductions. No milestone revenue was recognized under the agreement during the period from the acquisition date through September 30, 2026.
Intas Pharmaceuticals Limited License Agreement
In connection with the closing of the Kashiv Acquisition on August 10, 2026, the Company acquired an exclusive license agreement with Intas Pharmaceuticals Limited (“Intas”) pursuant to which Intas has the commercialization rights of lanreotide in Europe and India. The agreement provides for potential future development, regulatory, launch and sales-based milestone payments totaling up to approximately $23.5 million. Upon regulatory approval, the Company will be responsible for manufacturing and supplying drug substance to Intas. No milestone revenue was recognized under the agreement during the period from the acquisition date through September 30, 2026.