Company: DVAX
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001029142-25-000117
Chunk: 243

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 1
Chunk 243
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3, we received marketing authorization in the UK for HEPLISAV-B for the active immunization against hepatitis B virus infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.

In May 2021, we entered into a commercialization agreement with Bavarian Nordic for the marketing and distribution of HEPLISAV-B in Germany, and in May 2022, we commenced commercial shipments of HEPLISAV-B in Germany. The agreement was not renewed upon its expiration in the second quarter of 2025. Under the terms of the agreement, Bavarian Nordic retains the right to distribute remaining inventory of HEPLISAV-B in Germany through April 30, 2026, after which commercialization rights will revert to Dynavax. We do not currently market HEPLISAV-B outside the U.S. 

HEPLISAV-B product sales in the U.S. are to certain wholesalers and specialty distributors whose principal customers include independent hospitals and clinics, integrated delivery networks, public health clinics and prisons, the Department of Defense, the Department of Veterans Affairs and retail pharmacies. For the three and six months ended June 30, 2025, HEPLISAV-B product revenue, net was $91.9 million and $156.8 million, respectively.

CpG 1018® Adjuvant Supply for COVID-19 Vaccines 

In January 2021, we entered into an agreement (together with subsequent amendments, the "CEPI Agreement") with Coalition for Epidemic Preparedness Innovations (“CEPI”) for the manufacture and reservation of a specified quantity of CpG 1018® adjuvant. Through June 30, 2025, we have received approximately $175.0 million in advance payments (the “Advance Payments”) under the CEPI Agreement. Of this amount, $67.3 million has been repaid and $47.4 million has been forgiven. As of June 30, 2025, the remaining $60.3 million, representing the outstanding balance of the Advance Payments relating to the Clover Supply Agreement (as defined and discussed below), is recorded in CEPI accrual long-term in our condensed consolidated balance sheets, and may be repaid from collections from Clover or forgiven under the terms of the CEPI Agreement.

In June 2021, we entered into a commercial supply agreement (together, the “Clover Supply Agreement”) with Zhejiang Clover Biopharmaceuticals, Inc. and Clover Biopharm