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Collaborative Research, Development and License Agreements | 6 Months Ended
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Jun. 30, 2025
Research and Development [Abstract] |
Collaborative Research, Development and License Agreements | Collaborative Research, Development and License Agreements Coalition for Epidemic Preparedness Innovations In January 2021, we entered into an agreement (together with subsequent amendments, the “CEPI Agreement”) with Coalition for Epidemic Preparedness Innovations (“CEPI”) providing for the funding, manufacture and reservation of a specified quantity of CpG 1018 adjuvant. We refer to the adjuvant funded by CEPI and reserved for CEPI designees herein as “CpG 1018 Materials.” In exchange for manufacturing, reserving CpG 1018 Materials, and agreeing to sell CpG 1018 Materials to designated CEPI partners in specified quantities and at pre-negotiated prices, CEPI agreed to pre-pay the cost of such manufacturing in the form of an interest-free, unsecured, forgivable loan (the “Advance Payments”). We are obligated to repay the Advance Payments for CpG 1018 Materials, on a pro rata basis, only if, and to the extent, we receive payments from sales of CpG 1018 Materials reserved under the CEPI Agreement from designated CEPI partners. Under the terms of the CEPI Agreement, for any unsold CpG 1018 Materials reserved thereunder, the applicable Advance Payments would have been forgiven upon destruction by us at the end of the CEPI Agreement’s term, as defined therein. At the time the CEPI Agreement expired, we retained no CpG 1018 Materials. Our obligation to reimburse CEPI for any sold CpG 1018 Materials upon payment from a designated CEPI partner survived expiration, to the extent any remained outstanding. Through June 30, 2025, we received Advance Payments from CEPI totaling approximately $175.0 million pursuant to the CEPI Agreement, of which $67.3 million has been repaid by us and $47.4 million was forgiven by CEPI in connection with our Biological E Limited (“Bio E”) Supply Agreement dated July 2021 (the “Bio E Supply Agreement”), as amended. As of June 30, 2025, remaining Advance Payments totaling $60.3 million were reflected in CEPI accrual long-term in our condensed consolidated balance sheets, representing the outstanding balance of the Advance Payments relating to the CpG 1018 Materials we sold pursuant to the Clover Supply Agreement (as defined and discussed below). Zhejiang Clover Biopharmaceuticals, Inc. and Clover Biopharmaceuticals (Hong Kong) Co., Limited In June 2021, we entered into an agreement with Zhejiang Clover Biopharmaceuticals, Inc. and Clover Biopharmaceuticals (Hong Kong) Co., Limited (collectively, “Clover”) for the commercial supply of CpG 1018 adjuvant for use in Clover’s COVID-19 vaccine candidate, SCB-2019 (together with subsequent amendments, the “Clover Supply Agreement”). Under the Clover Supply Agreement, Clover committed to purchase specified quantities of CpG 1018 adjuvant, a portion of which included CpG 1018 Materials funded by CEPI, at pre-negotiated prices pursuant to the CEPI Agreement, for use in Clover’s commercialization of vaccines containing SCB-2019 and CpG 1018 adjuvant (“Clover Product”). During 2022 and 2023, we signed four amendments to the Clover Supply Agreement. The terms and conditions of the Clover Supply Agreement were operative through December 2022, and as of December 31, 2022, we had satisfied all delivery obligations thereunder. For CpG 1018 Materials reserved for Clover under the CEPI Agreement and purchased by Clover under the Clover Supply Agreement, Clover is obligated to pay us the purchase price upon the earliest of (i) the true-up exercise (as defined therein), (ii) within a specified period after Clover delivers Clover Product to a customer, (iii) Clover’s receipt of payment for Clover Product from a customer (as defined therein), or (iv) upon the CpG 1018 adjuvant no longer being sellable as part of a Clover Product. When we transfer control of CpG 1018 Materials that are reserved under the CEPI Agreement, we recognize product revenue and a corresponding contract asset, as our right to consideration is contingent on something other than the passage of time, as outlined above. During the six months ended June 30, 2025, we recorded an allowance for doubtful accounts of approximately $11.0 million relating to the contract asset recognized for Clover. This determination was based on our evaluation of credit risk associated with Clover, driven by the formal termination by the Global Alliance for Vaccines and Immunization (“GAVI”) of its advanced purchase agreement option with Clover on April 24, 2025, Clover’s recent write-down of the carrying value of its CpG 1018 Materials, and Clover's liquidity position, as reflected by cash and cash equivalents reported in Clover’s audited consolidated statement of financial position as of December 31, 2024. The $11.0 million allowance for doubtful accounts represents the portion of Clover's contract asset that is incremental to the amounts which were directly funded using the Advance Payments from CEPI of approximately $60.3 million to manufacture the corresponding CpG 1018 Materials. Accordingly, the contract asset balance associated with Clover was $60.3 million as of June 30, 2025, compared to $71.3 million as of December 31, 2024. The contract asset was included in other assets (non-current) and represents amounts due from Clover that we expect to become payable more than twelve months after June 30, 2025. Advance Payments from CEPI of $60.3 million are recorded in CEPI accrual long-term in our condensed consolidated balance sheets as of June 30, 2025. We are only obligated to repay these Advance Payments to CEPI if, and to the pro rata extent, of our receipt from Clover of their payment for the corresponding CpG 1018 Materials. Pursuant to the terms of the Clover Supply Agreement, we intend to continue to pursue collection of the full $71.3 million due from Clover. Of this amount, $60.3 million will be payable to CEPI upon the occurrence of the applicable payment trigger events described above, whichever occurs first. Biological E. Limited On April 26, 2023, we entered into a third amendment to the Bio E Supply Agreement (the “Bio E Amendment No. 3”). The Bio E Amendment No. 3 provides for additional future payment of either $5.5 million in the event that Bio E receives at least $125.0 million, or $12.3 million in the event that Bio E receives at least $250.0 million in future payments from the Government of India associated with its CORBEVAX product on or before August 15, 2025. These additional amounts are not considered collectible until the achievement of these future milestones. As of June 30, 2025, these future milestones have not been achieved and, as a result, we had no net accounts receivable balance from Bio E. In 2023, we recorded an allowance for doubtful accounts of $12.3 million, which was determined by assessing changes in Bio E’s credit risk and Bio E's dependence on cash collections from the Government of India, which have been delayed and significantly reduced in connection with the overall reduction in demand for CORBEVAX from the Government of India. U.S. Department of Defense In September 2021, we entered into an agreement with the DoD for the development of a recombinant plague vaccine adjuvanted with CpG 1018 adjuvant for approximately $22.0 million over two and a half years. Under the agreement, we conducted a Phase 2 clinical trial combining our CpG 1018 adjuvant with the DoD's rF1V vaccine. In July 2023, we executed a contract modification with the DoD to support advancement into a nonhuman primate challenge study, with the agreement totaling $33.7 million through 2025. In December 2024, we executed a contract totaling $30.0 million to support additional Phase 2 clinical and manufacturing activities to be performed through the first half of 2027. We recognized revenue of $3.3 million and $6.2 million from our agreement with the DoD for the three and six months ended June 30, 2025, respectively. We recognized revenue of $3.6 million and $6.4 million from our agreement with the DoD for the three and six months ended June 30, 2024, respectively. Revenue from our agreement with the DoD is included in other revenue in our condensed consolidated statements of operations.

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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. + References Reference 1: http://www.xbrl.org/2003/role/disclosureRef -Topic 808 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 1 -Subparagraph (a) -Publisher FASB -URI https://asc.fasb.org/1943274/2147479402/808-10-50-1 Reference 2: http://www.xbrl.org/2003/role/disclosureRef -Topic 808 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 1 -Subparagraph (b) -Publisher FASB -URI https://asc.fasb.org/1943274/2147479402/808-10-50-1 Reference 3: http://www.xbrl.org/2003/role/disclosureRef -Name Accounting Standards Codification -Topic 808 -Publisher FASB -URI https://asc.fasb.org/808/tableOfContent + Details
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