Dynavax's Heplisav performs well, but shows product inconsistency
Despite generally positive late-stage results for its experimental hepatitis B vaccine, Heplisav, Dynavax's stock price suffered after test lots showed product inconsistencies and a loss in Q2 revenue. One of three test lots showed a higher antibody response at 8 weeks than the other two lots.
"Everyone had expected the lot-to-lot consistency to succeed, and, in fact, this is one of the easier tasks for the company," Wedbush Securities analyst Duane Nash told Reuters. "(The inconsistency) has added unwanted and unexpected uncertainty."
When compared to GlaxoSmithKline's Engerix-B, an older hepatitis B vaccine, in a 2,449 patient study, Heplisav maintained a higher seroprotection rate 8 weeks after final dosage--90% rather than Engerix-B's 70%.
In the second quarter, Dynavax lost $10.6 million, or 9 cents per share, lower than the 11 cents per share expected by analysts. Thanks in part to a $6 million payment from GSK for its lupus drug partnership, revenue rose from $2.2 million to $7.3 million. According to a Dynavax call with analysts, the company will conduct another study, on request from the FDA. The additional study should not create significant delays in the product timeline, Dynavax said.