Dynavax Technologies Corporation (DVAX)

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Dynavax Technologies Corporation (DVAX)

June 10, 2013 9:00 am ET


Jennifer Lew - Vice President of Finance and Principal Accounting Officer

Eddie Gray - Chief Executive Officer and Director


Philip Nadeau - Cowen and Company, LLC, Research Division

Thomas Wei - Jefferies & Company, Inc., Research Division

Liisa A. Bayko - JMP Securities LLC, Research Division



Good day, everyone, and welcome to the Dynavax Conference Call. This call is being recorded. At this time, for opening remarks and introductions, I would like to turn the call over to Jennifer Lew, Dynavax's Vice President of Finance. Ms. Lew, please go ahead.

Jennifer Lew

Good morning. I'm Jennifer Lew, Vice President of Finance, and I'd like to thank you for joining us. Participating with me on the call today are Eddie Gray, CEO; and Michael Ostrach, Vice President and Chief Business Officer.

Before discussing today's topics, we need to advise that we will use forward-looking statements that are subject to a number of risks and uncertainties. Actual results may differ materially due to the risks and uncertainties inherent in our business. Examples of these forward-looking statements include, but are not limited to, the company's plans to respond to FDA's feedback regarding the BLA for HEPLISAV; the resources planned to be devoted to the BLA for HEPLISAV and the FDA Complete Response Letter; the sufficiency of data to be submitted to FDA; the timing and potential outcome of data-generating activities; regulatory submissions and decisions by the FDA on the BLA for HEPLISAV; and other difficulties or delays in clinical development, manufacturing, regulatory approval, market acceptance and commercialization of HEPLISAV. These forward-looking statements are based on the information available to us today. We may not actually achieve the plan, carry out our intentions or meet the expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements.

Actual results or events could differ materially. We assume no obligation to update these statements as circumstances change, except as required by law. For additional information, please see the Forward-looking Statement section in today's press release and the Risk Factors section of our quarterly report on Form 10-Q. I'd now like to turn the call over to Eddie Gray, our CEO.

Eddie Gray

Thanks, Jennifer. Good morning. I'm pleased to be here with you this morning to provide an update on our recent meeting with the FDA regarding HEPLISAV. Our comments on this call will be based on our current understanding of the issues and the steps that may be necessary to address them. Please bear in mind that we've only just met with the FDA a couple of days ago.

In my view, the outcome of the meeting was clear and followed, I think, predictably the themes expressed by VRBPAC last November. As we disclosed in the press release issued today, the main conclusions can be summarized as follows: Firstly, there was a strong endorsement for HEPLISAV's immunogenicity data demonstrated in previous clinical trials. In that context, the spirits and the tone of the interactions with the FDA suggest to us of their support for HEPLISAV's path forward to approval. Secondly, there was an acknowledgment that our safety database needs additional patients to support approval for any indication. Because HEPLISAV contains a novel adjuvant, we will need to increase the number of patients valuable for safety. Although we did discuss with FDA HEPLISAV's use in discrete patient populations, focusing on the improved benefit risk profile of the product in these groups, this approach did not address the fundamental issue of a shortfall in the safety database. Furthermore, our discussions suggest this would have necessarily restrict the patient population that could benefit from HEPLISAV's approval.

At this point, we are aligned with the FDA and understand the rationale for their recommendations. We remain optimistic that obtaining the additional safety data will facilitate FDA's review for an indication in adults 18 to 70 years old.

FDA has shown a continued interest in our adjuvant. If we can support competence in the safety of HEPLISAV, our efforts will underline the value of the adjuvant, and in many respects, serve to validate the underlying technology. And we believe that FDA reasonably understands that a safety study designed to include, say, 30,000 patients is not economically feasible for a small company like Dynavax. However, obtaining additional safety data at a scale roughly consistent with that discussed by VRBPAC is possible, and we intend to provide the FDA with further reassurance and greater insight.

We have started to work diligently on our proposed protocol. Whilst we cannot provide you with the specifics of this study today in terms of start date, duration or cost, we will continue our discussions with FDA and provide you with an update as soon as practicable.

Certainly, we're encouraged by FDA's continued support for HEPLISAV in a broader indication. Our challenge now is to manage the risks of ongoing development and the funding required. Employing financial discipline will be important as we determine time lines of incremental costs to finish this development.

In closing, let me also take a moment to remind you that our Marketing Authorization Application is under review by the EMA. We continue to pursue HEPLISAV's approval and commercialization in Europe. This concludes our prepared remarks.

Operator, you may now open the call to questions. Thank you.

Question-and-Answer Session


[Operator Instructions] Our first question comes from Phil Nadeau from Cowen and Company.

Philip Nadeau - Cowen and Company, LLC, Research Division

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