Dynavax Technologies Corporation (NASDAQ:DVAX) Q3 2019 Earnings Conference Call - Final Transcript

Nov 06, 2019 • 04:30 pm ET


Dynavax Technologies Corporation (NASDAQ:DVAX) Q3 2019 Earnings Conference Call - Final Transcript


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Good day, ladies and gentlemen, and welcome to the Dynavax Technologies Third Quarter 2019 Conference Call. [Operator Instructions]

I'd now like to turn the call over to Nicole Arndt, Senior Manager, Investor Relations, you may begin.

Nicole Arndt

Thank you, James. Good afternoon, welcome to the Dynavax third quarter 2019 financial results and corporate update conference call. With me today are Ryan Spencer, Co-President and Michael Ostrach, Chief Financial Officer.

Before we begin, I advise you that we will be making forward-looking statements today, including statements regarding HEPLISAV-B's commercial profile, revenue expectations, potential peak revenue and the completion of post-marketing studies. These statements are subject to a number of risks and uncertainties that could cause actual results to differ materially, these risks are summarized in today's press release and are detailed in the Risk Factors section of our current 10-Q and 10-K periodic reports filed with the SEC, which we encourage you all to read.

I will now turn the call over to Ryan Spencer, Co-President of Dynavax.

Ryan Spencer

Thanks, Nicole, and thank you all for joining us today for an update on Dynavax and to review our third quarter 2019 results, which we are very excited to share. There are few key things really take away from our discussion today about our focus and our ongoing transformation of the company.

To begin Dynavax is solely focused on growing our vaccine business with HEPLISAV-B sales as the main driver, continuing our successful commercial execution is our number one objective. Based on our clinical data in over 10,000 patients and perhaps more importantly, our interaction with healthcare providers and decision makers across each of our diverse customer segments. We believe HEPLISAV-B has the potential to become the standard-of-care adult hepatitis B vaccine in the United States, improving patient protection and representing a commercial opportunity with potential gross peak sales of about $500 million in the United States.

Due to our commercial teams continued strong execution, today we are pleased to report net sales of $10.2 million for the third quarter of this year. And as a result of this progress, we are raising expectations for net product sales for the full-year of 2019 to be between $34 million and $36 million. We're in a strong financial position with capital sufficient to execute well on our HEPLISAV-B commercial strategy, placing us on the path to profitability based on continued revenue growth in the US and management of operating expenses.

With these key takeaways in mind, let's turn to some specifics about HEPLISAV-B and our commercial efforts. So, starting with HEPLISAV-B's profile, HEPLISAV-B is the only 2 dose hepatitis B vaccine that has been approved by the FDA and has demonstrated higher rates of protection in head-to head clinical studies, compared to the 3 dose regimen Engerix-B, which is the current market leader.

Importantly challenges with compliance are well known with only 30% to 55% of patients completing the legacy products 3 dose regimen, which take six months to administer. Now as you can imagine the potential