Dynavax Secures $175 Million in Funding to Support Launch of Recently Approved Heplisav-B


Three months after winning regulatory approval for Heplisav-B, a hepatitis B vaccine, Dynavax Technologies has secured the financing to help commercialize the new medication and send a new sales team out into the trenches.

This morning Bay Area-based Dynavax announced it secured a $175 million non-dilutive term loan agreement with healthcare-focused investment firm CRG LP, to commercialize Heplisav-B. Dynavax said it will receive an initial $100 million to finance its commercialization efforts and the remaining $75 million can be borrowed in a second trance at the company’s option.

Shares of Dynavax are up slightly on the news in pre-market trading. The stock increased to $17.55 per share, up almost 2 percent from the closing price of $17.22.

The funds from the loan will be coupled with $192 million in cash the company had in its war chest at the end of 2017. Michael Ostrach, chief financial officer at Dynavax, said the combined funds will allow the company to implement its commercialization plans in the United States. Additionally, the company will use the funds to expand and advance clinical studies of our immuno-oncology product candidates, Ostrach said in a statement. Interest on the term loans will accrue at a rate of 9.5% per annum with the principal to be repaid at maturity on December 29, 2023.

"Our strong cash position will support the launch of our HEPLISAV-B field sales team next week and the phase 3 clinical trial of SD-101 and additional Phase II trials planned to start later this year,” Ostrach said.

Heplisav-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like receptor 9 agonist to enhance the immune response. The medicine is administered twice per month. Heplisav-B is expected to go head-to-head against GlaxoSmithKline’s HBV treatment Engerix-B. In Phase III trials, Heplisav-B showed non-inferiority against the GSK drug and it’s administered in fewer doses.

Dynavax’s SD-101 is an investigational TLR9 agonist designed to elicit a potent and focused immune response to cancer. According to company data the administration of SD-101 to a tumor activates natural killer cells, blocking immune suppression, and promoting Th1 and CD8+ T cell homing into the tumor.

Heplisav-B became available in January. The Wholesale Acquisition Cost for HEPLISAV-B is $115 per dose or $230 per regimen, the company said in January. The new sales team will target institutions, the largest independent accounts, and influential accounts that are current hepatitis B vaccinators, Dynavax said. Dynavax said it is working with an extensive network of group purchasing organizations and government entities to ensure all patients have access to Heplisav-B.

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