Good day, ladies and gentlemen, and welcome to Dynavax Technologies' Third Quarter 2023 Financial Results Conference Call. As a reminder, this call is being recorded. At the end of the company's prepared remarks, we will open the call for questions and provide specific participation instructions at that time.

I would now like to turn the call over to Paul Cox, Vice President, Investor Relations and Corporate Communications. You may begin..

Thanks you all for participating in today's call. Joining me today from Dynavax are Ryan Spencer, Chief Executive Officer; Donn Casale, Chief Commercial Officer; Rob Janssen, Chief Medical Officer; and Kelly MacDonald, Chief Financial Officer. Earlier today, Dynavax released financial results for the third quarter ended September 30, 2023.

Copies of the press release and a supplementary slide presentation are available on Dynavax's Web site.

Before we begin, I advise you that we will be making forward-looking statements today based on our current expectations and beliefs, including but not limited to, potential market sizes, market segmentation, effective marketing efforts, future expected market share and related growth rates and related ACIP recommendation impacts on each, financial guidance and trends including revenue, profitability, cash flow, and sufficiency of current capitalization, timing and results of FDA submissions, clinical trial starts and data readouts and potential future uses or demand for our CpG 1018 adjuvant.

These statements involve risks and uncertainties and our actual results may differ materially. These risks are summarized in today's press release and detailed in the risk factors section of our SEC filings, including today's quarterly report on Form 10-Q.

Our forward-looking statements speak as of today, and we undertake no obligation to update such statements. And with that, I will now turn the call over to Ryan..

Thanks, Paul. Good afternoon everyone and thank you for taking the time to join us to review Dynavax's results for the third quarter of 2023. We're pleased to report yet another record quarter of HEPLISAV-B revenue as we progress toward our goal of establishing HEPLISAV-B as the leading adult hepatitis B vaccine in the U.S.

and market opportunity, which we believe will continue to expand to over $800 million by 2027. HEPLISAV-B delivered $62 million in quarterly net product revenue, which is a 66% year-over-year increase.

This record quarter was driven by market share gains in the overall adult hepatitis B vaccine market, and in particular by HEPLISAV-B gaining majority market share in both the key market segments of retail pharmacy and integrated delivery networks.

As a result of the strong HEPLISAV-B performance in the first nine months of the year, we are again raising our revenue expectations for the full year. We now expect HEPLISAV-B net product revenue to be in the range of $210 million to $220 million, representing up to 75% growth this year.

Based on our commercial execution to date, we continue to strengthen our financial position, with cash and investments increasing to $720 million at quarter end.

This position enables us to support our efforts to maximize HEPLISAV-B's opportunity in this growing market, while also advancing our clinical pipeline into the next stage of trials in 2024, which Rob will cover in a few minutes.

In addition, as we've discussed on prior calls, we continue to evaluate strategic opportunities to diversify our product portfolio and create future commercial opportunities. We remain committed to discipline capital allocation to generate significant value and accelerate growth. We look forward to providing updates on these efforts in the future.

I'll now turn the call over to Donn to provide more details on the tremendous HEPLISAV-B performance in third quarter..

Thank you, Ryan. I'm excited to share more details about another very strong quarter for HEPLISAV-B. We achieved record net product sales and market share in the quarter. The hepatitis B market continues to grow in the U.S.

following the ACIP universal recommendation for hepatitis B vaccination, which now represents one of the largest vaccine market opportunities for adults.

As a reminder, we believe this recommendation will be a significant catalyst for growth and estimate the hepatitis B vaccine market could grow to over $800 million by 2027, with HEPLISAV-B achieving a majority market share by that time. We continue to see indicators of market expansion from ACIP universal.

In the third quarter, the total hepatitis B vaccine market grew by approximately 29% year-over-year. HEPLISAV-B continues to increase its total market share, achieving 41% in the quarter compared to 32% during the same period last year. Net product revenue grew 66% year-over-year to $62 million in the quarter.

This sales growth continues to be driven by HEPLISAV-B strong performance in two critical segments, retail pharmacy and integrated delivery networks or IDN.

We continue to focus our sales and marketing efforts on the retail pharmacy and IDN segment as we expect to see most of the anticipated market growth from the universal recommendation in these segments, estimating both will grow to represent approximately 60% of the total hepatitis B market by 2027.

At the end of the third quarter, HEPLISAV-B's market share increased approximately 54% compared to approximately 43% at the end of the third quarter last year. We are focused on working with large health systems at the C-suite and clinic level to pull through ongoing adoption of the universal recommendation.

In this segment, we are seeing continued strong conversion and expansion from large customers that are adopting the universal recommendation driving meaningful increases in their hepatitis B vaccine purchases. In the third quarter, year-over-year hepatitis B vaccine market growth in the IDN segment was approximately 40%.

In the retail pharmacy segment, we have made significant progress year-to-date, including several large national chains making HEPLISAV-B the preferred adult hepatitis B vaccine. In the third quarter, HEPLISAV-B achieved a majority share in this important segment, which is expected to drive significant growth in the coming years.

Year-over-year, hepatitis B vaccine market growth in the retail pharmacy segment was 80% with HEPLISAV-B's market share increasing to approximately 53% compared to approximately 43% at the end of the third quarter last year.

During the third quarter, we completed the optimization of our sales force to expand our promotional reach in the retail pharmacy segment which is intended to further drive market expansion. This expanded sales force reach will call on headquarters, divisional, regional and district leaders across the top retail chain.

We're also excited to see the impact of our collaborative marketing initiatives with top national retail chains that launched at the end of the second quarter.

We expect the strong collaborative relationships across the top retail chain plus our expanded sales force reach will enable continued strong market growth and market leadership within this important segment over the years to come.

As Ryan noted, based on our progress year-to-date and the strong results, we're raising our full year 2023 net product revenue guidance for HEPLISAV-B to be in the range of $210 million to $220 million.

This updated guidance reflects our tremendous momentum in the market, while still factoring in expected fourth quarter seasonality and the impact from customer focus vaccine efforts on the new RC vaccine, COVID revaccination and seasonal flu.

We believe the strain on customer bandwidth due to RC, COVID and flu vaccination will be temporary and limited to the fourth quarter.

We remain extremely confident in the long-term growth of the hepatitis B market and are forecasting annual growth of approximately 10% to 50% over the next several years with HEPLISAV-B continuing to gain meaningful increases in total market share over that time.

In summary, we had an outstanding third quarter, reaffirming our confidence in HEPLISAV-B becoming the market leader in the expanding hepatitis B vaccine market.

We are very proud of our commercial teams' execution and encouraged by the progress and momentum for HEPLISAV-B, establishing a majority market share in the key segments of retail pharmacy and IDN. I will now turn the call over to Rob to take you through our clinical pipeline..

Thank you, Donn. As a reminder, in our development pipeline, we're advancing innovative and diversified vaccines that leverage our CpG 1018 adjuvant with proven antigens. We also continue to identify new opportunities to leverage our CpG 1018 adjuvant through multiple innovative preclinical and discovery efforts with leading collaborators.

Starting with our shingles vaccine program, Z-1018. Currently, there is a blockbuster vaccine on the market, but we believe that there's an opportunity to develop and improve vaccine given the challenging tolerability profile of the current market leading product.

One of the unique advantages we believe of our CpG 1018 adjuvant is its safety and tolerability profile combined with its ability to induce strong CD4+ T cell responses, which we believe are critical to preventing the reactivation of the zoster virus.

Results from our Phase 1 trial support the continued development of Z-1018 as they demonstrate the opportunity to develop a shingles vaccine with an improved tolerability profile and comparable efficacy. Recently, we received Type B meeting feedback from FDA on the Z-1018 program.

We believe this feedback is supportive of our proposed clinical development plan that includes a pivotal Phase 3 placebo-controlled efficacy study. Based on this feedback, we plan to submit an IND application to the FDA to support the initiation of the Phase 1/2 trial of Z-1018 in the first half of 2024. Turning next to the Tdap-1018 program.

So this is an investigational vaccine candidate that's intended for active booster immunization against tetanus, diphtheria, and pertussis or Tdap.

Current Tdap vaccines have limitations, including waning effectiveness, and we believe there's an opportunity to improve the duration of protection using our CpG 1018 adjuvant to generate a Th1-biased immune response. We've completed both a Phase 1 clinical trial in adults and adolescents as well as a pertussis challenge study in non-human primates.

We recently received Type B pre-IND meeting feedback from FDA on the Tdap-1018 clinical development and regulatory pathways. Together, results from our Phase 1 study, our non-human primate study and the feedback from FDA all support proceeding to a human challenge study in mid 2024. Moving on to the plague program.

This is in collaboration with and funded by the U.S. Department of Defense. We're conducting a Phase 2 trial evaluating the immunogenicity, safety and tolerability of a two dose plague vaccine candidate that's adjuvanted with CpG 1018.

The CpG 1018 adjuvanted vaccine candidate's mechanism of action has the potential to speed up time to protection with fewer doses compared to the three dose adjuvanted regimen that has been previously evaluated by the DoD. Earlier this year, we successfully completed part one of the Phase 2 study and subject dosing in part two is now complete.

We anticipate top line data in 2024. Dynavax in the U.S. Department of Defense recently executed a contract modification to support advancement of the plague vaccine candidate into a non-human primate challenge study, which was initiated in August.

In addition to these development programs, we've also filed a supplemental BLA for HEPLISAV-B vaccination of adults on hemodialysis, which the FDA has accepted with a PDUFA action date in May of 2024.

Now, if approved, this would allow us to promote a four dose regimen of HEPLISAV-B for the dialysis population, which comprised about 11% of the total U.S. hepatitis B vaccine market in 2022. We look forward to continuing to make progress across these programs in the months ahead.

And we're excited to initiate the next clinical trials for both our shingles and Tdap programs in the coming year. I'll now turn the call over to Kelly to review our financial results..

Thank you, Rob. I'm excited to report on a strong third quarter. I'll review the key financial results and then share our updated guidance for the full year. Please note that all financial comparisons are versus the prior year period, unless otherwise noted. Please also refer to our press release and Form 10-Q for detailed financial information.

Starting with revenue. Total revenues for the third quarter of 2023 were $70 million, driven by HEPLISAV-B net product revenue of $62 million. During the third quarter of last year, HEPLISAV-B net product revenue grew by 66%. We continue to be excited about the uptake trajectory for HEPLISAV-B with consistent growth in key market segments.

Based on the strong results for the first nine months of the year, we are raising our HEPLISAV-B net product revenue guidance for the full year to $210 million to $220 million compared to prior guidance of $200 million to $215 million, reflecting our competence in HEPLISAV-B's continued growth for the full year.

We are also pleased with the continued trend in the margin profile for HEPLISAV-B with gross margin of approximately 79% in Q3 compared to about 69% last year. And we continue to expect gross margins to average in the mid 70s for the full year.

HEPLISAV-B margin improvements have been driven by lower per unit manufacturing costs as a result of the previous investments to drive process development improvements.

Other revenue was $7 million in the third quarter compared to $4 million in the prior year period, representing revenue related to the plague vaccine program in collaboration with and funded by the U.S. Department of Defense. The increase was primarily driven by the advancement into a non-human primate challenge study.

Now turning to our research and development expenses for the quarter, which increased to $14 million compared to $13 million for the prior year period. The increase was driven by continued advancements in our clinical and preclinical development programs in collaboration.

Selling, general and administrative expenses for the quarter were $38 million compared to $32 million in the prior year period.

The increase was primarily driven by higher compensation and related personnel costs, and an overall increase in targeted commercial and marketing efforts designed to increase HEPLISAV-B market share and maximize the opportunities presented by the ACIP universal recommendation.

These results generated GAAP net income of $14 million or $0.11 per share basic and $0.10 per share diluted in Q3 compared to the GAAP net income of $64 million or $0.50 per share basic and $0.43 per share diluted for the prior year period. Moving to the balance sheet.

We ended the third quarter with cash, cash equivalents and marketable securities of approximately $720 million, an increase compared to our year-end balance of $624 million the end of 2022. Based on our current operating plan, we continue to expect to finish 2023 with a positive free cash flow for the year.

We are revising our full year 2023 financial guidance expectations, including raising our HEPLISAV-B net product revenue expectations to be between approximately $210 million to $220 million and refining our operating expense guidance including research and development expenses to be between $50 million to $60 million, as well as some general and administrative expenses to be between $145 million and $155 million.

In closing, we believe that with our strong financial profile, we are well positioned to drive sustainable growth in our core HEPLISAV-B business, capture a majority market share and lead the expansion of the adult hepatitis B vaccine market.

We look forward to progressing our R&D portfolio of vaccine candidates while continuing to be extremely thoughtful, and how we allocate our capital to accelerate growth and build beyond our current base business. We are excited about our progress to date. And we look forward to continuing to deliver on our goals for this year and beyond.

Thank you everyone for your attention today. Operator, we would now like to open the Q&A portion of today's call..

Thank you. [Operator Instructions]. Our first question comes from the line of Matthew Phipps with William Blair. Your line is now open..

Good afternoon. Thanks for taking my question. Congrats on another great quarter and great market share gains. Donn, real quick, you mentioned -- I think you said you expect that the total market to have 10% to 15% annual growth over the next several years.

Just want to make sure you're referring to total market there and then you guys ability to gain market share on top of that?.

Hi, Matt. How are you doing? Yes, so my comments were around the entire hep B market would be we expect around 10% to 15% year-over-year growth for the next couple of years, so it's total..

Yes. Okay. Thank you for clarifying that. In the shingles plans now that you got the feedback, congrats on confirming a placebo-controlled Phase 3.

So is the next step still to evaluate multiple doses of the antigen that you are producing yourself?.

Hi, Matt. Thank you for the question. Yes, that's the plan for the Phase 1/2 study to evaluate a couple of different doses of antigen..

All right. And then lastly, Ryan, earlier this year, you talked a little more about potential for external business development as being a priority, but now I don't really see any mention of that.

Is that due to more a change and excitement on your end for the internal shingles and Tdap programs or maybe just a lack of attractive external opportunities?.

No, it's still a priority. We mentioned it in my opening remarks. It still continues to be a priority for us to find opportunities to accelerate growth..

All right. Thanks for taking the questions..

Thank you. One moment for our next question please. Next question comes from the line of Ernesto Rodriguez-Dumont with Cowen. Your line is now open..

Hi. Congratulations on another great quarter. Thanks for taking our questions. So you gained market share in both segments, the IDN segment and the retail segment. But it seems like at least the quarter-over-quarter share gain was more pronounced in the retail segment than the IDN segment.

I was wondering, is that noise or is that maybe reflect more difficulty penetrate the IDN market at this moment or anything like that?.

Hi, Erne. This is Donn. I think the best way to think about the two segments, IDN is probably more consistent around buying purchases and buying patterns versus within the retail segment. You can see more either seasonality or different types of purchasing patterns that will drive more fluctuation in market share.

So these are different types of segments if you think about the hep B market..

Okay.

And then looking into 2024 and the BLA in the dialysis population, should we expect sort of like an inflection point there, or I guess what's your expectation on further acceleration if and when you get data label expansion?.

Hi, Erne. This is Ryan. We haven't actually provided any guidance for '24. And I think I understand your point as far as when we're able to start promoting. But we would like to first get through the approval, engage the customer before we're able to make any commentary around specific expectations in that segment..

Okay. Thanks. Congratulations, again..

Thank you..

Thank you..

Thank you. One moment for our next question. Next question comes from the line of Jonathan Miller from Evercore ISI. Your line is now open..

Hi, guys. Thanks very much for taking the question. And I'll join everybody else in congratulating you on another great quarter. I would love to get some color maybe on gross margin trends. I know you announced earlier this quarter that you had better pricing in your manufacturing contract.

How should we expect gross margin to evolve as volumes increase? And then maybe secondarily, as you're growing market share nicely overall and in those key segments that you've been talking about, is there anywhere that's proving challenging to grow, places where legacy contracting is slowing things down or there's some other headwind? And is there any dynamic related to that, that we can expect a change going forward?.

Hi, Jon. Thanks for the question. This is Kelly. I'll take the first one, then hand it over to Donn for the second question. We're really proud of the way that we've been able to execute some of the margin improvement.

This is a result of many years of investments and efficiencies that we've made not only in our Duesseldorf facility, but as we continue to engage with our CMOs for adjuvant manufacture. You can see the improved trends throughout the year, as you noted.

Additionally, and just as a reminder, we did reissue our guidance or reiterate our guidance that we believe for the full year. We're going to have average gross margins in the mid 70s. And we would expect next year to continue to see strong margins, more or less consistent with what we've seen in this most recent quarter.

Donn?.

Yes. And Jon, regarding market sharing, obviously, you heard the numbers regarding retail pharmacy and IDN. We're really proud of the market share gains quarter-over-quarter.

One of the areas that's difficult and always has been difficult is kind of this long tail of a customer which is probably 40,000 locations that order very little hepatitis B vaccine. So penetrating that universe of customers has been challenging from a market share perspective.

But certainly that's why we focus our efforts back to retail, back to IDN where we believe the vast majority of growth will happen in those two segments, so we feel very confident around our growth opportunities and as we look ahead. But from a market share perspective, it's been that long tail that's been difficult in the past for market share..

Great. Thanks so much. And then maybe if I can squeeze one more in there to piggyback on that earlier question about BD.

Given that it's still a priority for you, how do you view the current market environment evaluations that are out there as a potential acquirer? I think we've been seeing some motion in that across the industry, but it does feel like there's opportunities from evaluation perspective.

How do you view infectious disease relative to the rest of the market?.

Yes. Thanks, Jon. We agree. I think it's hard to miss that point. But we have to really focus on staying disciplined and finding the right fit for us for our business and our plans going forward. I think the trap of a good deal is not something we're really going to fall into.

We want to really make sure it's the right thing for our business, and this requires us to continue to be disciplined..

Thanks so much, guys..

Thank you. One moment for our next question please. Our next question comes from the line of Roy Buchanan with JMP Securities. Your line is now open..

Hi. Thanks for taking the questions. I've had a few follow ups on 1018. Just if you could give any more detail around what the FDA said. You have the actual minutes back from the meeting. Did they explicitly recognize the correlative protection for the pivotal trial? Just any other details you can give us around a potential pivotal design? Thanks..

Hi, Roy. This is Ryan. I'll just make a quick high level comment. Rob can add to it. I think we still continue to believe that this is a placebo-controlled efficacy study, not a correlative protection for the Z-1018 program. And the engagement with the FDA and the written response indicated support for that approach.

Rob, do you have any other comments to make on top of that?.

Yes. It's an efficacy study. So there was no mention of correlates nor did we really ask about correlates. And I think the design of the study is going to be pretty typical of GSK's old design for Shingrix in terms of size end points. We haven't finalized any of that, but don't be surprised if it looks a lot like that..

Okay, great. That seems like a pretty big win in my view. And then just a quick one for Kelly. I guess what's driving the decrease in the R&D guidance for the year? Thanks..

Thanks, Roy. So it is timing of deployment of our spend here..

Okay. Thank you..

Thank you. We have no further questions at this time. I would like to turn the call over to Mr. Ryan Spencer, Chief Executive Officer, for closing remarks. You may begin..

Thank you, operator. And thank you all for joining us today. We appreciate your interest in Dynavax. We're excited about our recent accomplishments and the strength of our position. We look forward to updating you on our progress. Operator, you may end the call..

Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for joining us. You may now disconnect. Everyone, have a wonderful day..