Dynavax Technologies Corporation (NASDAQ:DVAX) Q4 2023 Earnings Call Transcript

Paul Choi: Okay, thanks for that. And then a follow-up, I know you and the team have talked about BD and or partnering here, but I guess as you sort of survey the landscape and sort of where potential bid-ask spreads or is perhaps risk appetites are I guess as partnership or BD opportunities don’t materialize in the let’s say the next 12 to 18 months, how would you think about then rank ordering on your capital allocation outside of investing in the HEPLISAV-B business? Thanks so much for taking our questions.

Ryan Spencer: All right. Thanks, Paul. Yes. No I think I appreciate you highlighting the fact that there’s a lot of flexibility and identifying the right asset for Dynavax. And so Kelly why don’t you provide some commentary on our overall capital allocation strategy?

Kelly MacDonald: Sure/ So our exceptional commercial execution for HEPLISAV-B along with our hydrogen supply business of course has created this strengthening of our financial profile. We certainly believe that strong position will help us drive further growth including first and foremost looking for opportunities to invest in driving growth in HEPLISAV-B as well as advancing our organic clinical stage assets as well as our preclinical portfolio. As we as we reflect on opportunities outside of that to Ryan’s comments around corporate development. We do continue to evaluate strategic opportunities to diversify our commercial and clinical product portfolio. And then beyond that certainly, we do – we do evaluate and consider other opportunities to either return capital to shareholders if and when appropriate, as well as other ways to generate value for our shareholders. So that’s sort of the rank ordering where we stand today

Ryan Spencer: Thanks, Paul.

Paul Choi: Ryan, thank you.

Operator: Thank you. Our next question comes from the line of Ernesto Rodriguez-Dumont with Cowen. Your line is now open.

Ernesto Rodriguez-Dumont: Hi, everybody. Thanks for taking our questions and congrats on a great year. I have a question about the – on the effect that you described from the longer than expected respiratory vaccine season and the Q4 seasonality. Are those effects overcome during Q4 and Q3? Or do you have to like internally adjust your estimates for 2024 based on that. And then second question regarding the gross margins. What’s driving the improvement in gross margin, you said economies of scale and lower cost or are you expecting to have more pricing power? Thank you.

Ryan Spencer: Yes. I’ll take the first one and Kelly if you can handle the second one once you’re done. As far as, Ernie, thanks for the question. I interpreted the first part of the question to say because what we see in Q1 impact how we think about the rest of the year, does it change how we update our guidance. I mean ultimately, we only drive one guidance number when we’re ready to provide it. So I don’t it’s kind of hard to think about how individual factors impacted. But like we said in the call script, we know that Q2 and Q3 will continue to be the strongest quarters of the year. Our continued interactions with our customers are incredibly positive. So we’re excited to get out of the respiratory season, respiratory vaccine season and start working with our customers on the non-respiratory part of the year to really drive growth in this market. Kelly, can you hit on the gross margin pressure

Kelly MacDonald: Sure. On gross margins for Atlas SB these margin improvements have been driven by a couple of things, but and namely you noticed decreasing our per unit manufacturing costs. How we made a number of investments in our manufacture — antigen manufacturing facility in Germany. We are really proud of the way that we’ve been able to pull-through those on improving yields over time to realize you know sort of an estimate of approximately 80% gross margin for 2024. To reiterate another point that I made in the prepared remarks we do expect that 80% gross margin range to represent it – its levels that are consistent with our long-term expectations for this brand.

Q – Ernesto Rodriguez-Dumont: Okay. Very helpful. Thank you.

Ryan Spencer: Thank you, Ernie.

Donn Casale: Thank you.

Operator: Thank you. One moment for next question. Our next question comes from the line of Edward White, H.C. Wainwright. Your line is now open.

Unidentified Analyst: Hey, this is Steve on for Ed White. Few questions. For the shingles vaccine, do you have a expected timing to market?

Ryan Spencer: Well, we haven’t commented on the long-term the specificity of our launch. Obviously, it’s a full clinical development program. So we’re taking it could take multiple years to move forward. We have we have commented on the Phase 1/2 trial and the expectation to have that data in 2025. And then we’ll have to roll forward from there, Steven on expectations from the moving into the next study, site in the study looking at enrollment that dynamics to figure out or gotten when that would be able to readout. So it’s a little premature for us to predict the specific timing of filing and ultimate approval, but we have provided general commentary there and traditional vaccine development pathway. And there’s good reference points for prior trials conducted in this space to get a sense of timelines taken for those studies.

Unidentified Analyst: Okay. Thank you. And so there were no adjuvant sales this year, right?

Ryan Spencer: No adjuvant sales this year. We don’t contemplate additional asset sales for our COVID partnerships in 2024 at this time.

Unidentified Analyst: Okay. And what about in 2025 and going forward?