Company: DVAX
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001029142-25-000117
Chunk: 292

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 8
Chunk 292
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 vaccines approved for the prevention of hepatitis B in the U.S.: Engerix-B and Twinrix® from GlaxoSmithKline plc, Recombivax-HB® from Merck & Co and PreHevbrio™ from VBI Vaccines Inc. In February 2021, we received Marketing Authorization of HEPLISAV-B from the European Commission for prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. In March 2023, 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.