Good day ladies and gentlemen and welcome to the Dynavax Technologies' Fourth Quarter and Full Year 2023 Financial Results Conference Call. As a reminder, this call is being recorded. At the end of the company's prepared remarks, we'll open the call for questions and provide specific 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..

Thank you for participating in today's call. Joining me 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 fourth quarter and full year ended December 31st, 2023.

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

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 impact 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 of order 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 Annual Report on Form 10 K.

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 results for 2023.

2023 was characterized by record revenue growth for HEPLISAV-B, delivering 69% growth year-over-year, and becoming the market leader market share leader in the two largest growth segments, which are retail pharmacies and integrated delivery networks, making HEPLISAV-B the leading vaccine in the U.S. adult hepatitis B vaccine market.

We expect 2024 to be an important year in building our vaccine portfolio of best-in-class products including further growing the HEPLISAV-B brand and advancing our pipeline programs into clinical trial initiations and data readouts.

For HEPLISAV-B, we are again forecasting continued growth with net product revenue in the range of $265 million to $280 million for the year. In a few minutes, Donn will provide some additional commentary on how the U.S.

hepatitis B vaccine market is evolving due to an active winter respiratory disease season and why we continue to be very confident in another year of growth for the brand and in the long-term prospects for HEPLISAV-B in the vaccine market with one of the largest total addressable populations in the United States.

For our development pipeline, we expect to achieve important milestones in the coming months, including our PDUFA action date for the HEPLISAV-B SBLA for hemodialysis expected in May; clearing our shingles IND, currently being reviewed by FDA to begin our Phase 1/2 trial; advancing our Tdap program; and delivery Phase 2 clinical and non-human primate challenge study data for our plague program under collaboration with the U.S.

Department of Defense. Importantly, our strong financial position of $742 million of cash provides us with the optionality to continue to build value across our business, such as through incremental investments to drive the HEPLISAV-B market opportunity, continuing to advance R&D efforts, and pursuing new opportunities to accelerate our growth.

As we've discussed previously, we continue to evaluate strategic opportunities to further diversify our clinical and commercial product portfolio. We remain committed to disciplined 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 HEPLISAV-B results and our guidance looking forward..

Thank you, Ryan. In 2023, we achieved a record net product sales and market share, establishing HEPLISAV-B as the leading adult hepatitis B vaccine in the U.S. market. Additionally, we drove significant hepatitis B market growth by effectively pulling through the ACIP universal recommendation.

Our success in 2023 reaffirms our confidence in the sizable market opportunity and long-term revenue growth potential for HEPLISAV-B. U.S. adult hepatitis B market continued to grow in 2023 following the ACIP universal recommendation for hepatitis B vaccination, which now represents one of the largest vaccine market opportunities for adults.

We believe this recommendation will continue to be a significant catalyst for growth and estimate the hepatitis B vaccine market opportunity for HEPLISAV grew to approximately $525 million in 2023 on a clear path to approximately $800 million by 2027 with HEPLISAV-B achieving a majority market share by that time.

During the fourth quarter, we continued to see indicators of U.S.

market expansion from the ACIP universal recommendations despite softness in the market related to reduced wellness visits and an increased focus by healthcare providers on respiratory disease vaccines, including typical flu campaign and the launches of RC and endemic COVID-19 vaccines. HEPLISAV-B continues to increase its total U.S.

market share achieving 42% at the end of 2023, compared to 35% at the end of 2022. Net product revenue in 2023 grew 69% year-over-year. The sales growth continues to be driven by HEPLISAV-B strong performance in two critical segments, retail pharmacy and integrated delivery networks or IDNs.

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

As I said, we have now the market share leader in both of these key segments. For IDNs, at the end of the year HEPLISAV-B market share increased to approximately 56% compared to approximately 47% at the end of 2022.

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. Customers continue to respond positively to the ACIP change and recognize the need to adopt and implement the recommendations. Full year hepatitis B vaccine market growth in the IDN segment was 41%.

In the Retail Pharmacy segment, we have made significant progress in several large national chains making HEPLISAV-B the preferred adult hepatitis B vaccine. At the end of the year, HEPLISAV-B achieve approximately 58% market share in the retail pharmacy segment compared to approximately 42% at the end of 2022.

We continue to see and expect significant growth from the Retail Pharmacy segments. Full-year hepatitis B vaccine market growth was 78%. As Ryan noted, we are providing full year 2024 for net product revenue guidance for HEPLISAV-B to be in the range of $265 million to $280 million.

This guidance reflects our momentum in the market while factoring in the evolving market landscape and emerging quarterly patterns of non-respiratory vaccination that we expect to see in 2024.

Based on feedback from customers cough, cold and flu season has extended much further into January than expected reducing the number of wellness visits and vaccination opportunities. Due to softness in January, we anticipate little to no growth in the hepatitis B vaccine market for Q1, as compared to Q4 2023.

Encouragingly, we expect the market to strengthen for the remainder of Q1 into Q2 as the focus of health care providers and retail pharmacy shifted back to prioritizing non-respiratory vaccines. As a result, we expect to recognize up to 60% of our full year revenue range in the second and third quarters with typical Q4 seasonality expected.

We are extremely confident in the long-term expansion of the U.S. hepatitis B vaccine market and forecast annual market growth of approximately 10% to 15% over the next several years with HEPLISAV-B gaining meaningful increases in total market share over that time.

In summary, we had a tremendous 2023, reaffirming our confidence that HEPLISAV-B will strengthen its position as the clear market leader in the expanding hepatitis B vaccine market.

We are very proud of our commercial team's 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 Z1018. Currently, there's a successful licensed vaccine on the market, but we believe there's an opportunity to develop an improved 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 it safety and tolerability profile combined with its ability to induce strong CD4 positive T-cell responses which we believe are critical to preventing the reactivation of Zoster Virus.

Results from our Phase one trials support the continued development of Z1018, as they demonstrate the opportunity to develop a shingles vaccine with an improved tolerability profile and comparable efficacy.

Late last year, we received Type B meeting feedback from the FDA on the Z1018 program which we believe is supportive of our proposed clinical development plan that includes a pivotal placebo-controlled efficacy study.

We recently submitted an investigational new drug application or IND to the US FDA to support the initiation of a Phase one two trial of Z1018. In the first half of 2024, we will be evaluating escalating doses of RGE protein our selected dose of CpG 1018 with or without alum and different vaccination schedules.

We plan to enroll approximately 400 subjects and anticipate tight top line immunogenicity data in the second half of 2025. Now turning next to our Tdap 1018 program. This is an investigational vaccine candidate intended for active booster immunization against tetanus diphtheria and pertussis or Tdap.

Our Tdap have limitations including waning effectiveness. We believe there's an opportunity to improve the duration of protection using our CpG 1018 adjuvant to generate a Th one biased immune response. We've completed both a Phase one clinical trial in adults and adolescents, as well as a pertussis challenge study in nonhuman primates.

We recently received type the pre-IND meeting phase feedback from the FDA on the Tdap 1018 clinical development and regulatory pathways. Together, results from our Phase one studies our nonhuman primate study and the feedback from FDA all support proceeding to a human challenge study this year.

We plan to submit an IND to the US FDA to support the initiation of this Phase two human challenge study of Tdap 1018 in the second half of the year upon completion of the independent study being conducted by the Canadian center for vaccinology to establish the human challenge dose which we will utilize in our Phase two study.

Moving onto the plague program. This is a collaboration with and funded by the US Department of Defense. We are conducting a Phase two trial evaluating the immunogenicity, safety and tolerability of a two-dose plague vaccine candidate that is adjuvanted with CpG 1018. The CpG 1018 adjuvanted vaccine candidates.

Mechanism of action has the potential to speed up time to protection with fewer doses compared to the three-dose alum adjuvanted vaccine previously developed by the Department of Defense.

We're currently conducting a randomized active controlled Phase two clinical trial evaluating immunogenicity safety and tolerability of the plague vaccine candidate. And in parallel, we're conducting a nonhuman primate challenge study.

We expect top line data from both of these studies by the end of 2024 and these data will inform next steps for the program. Now in addition to these development programs, we've also filed a supplemental BLA for hepatitis B vaccination of adults on hemodialysis which the FDA has accepted with a PDUFA action date in May of 2024.

If approved, this would allow us to promote a four dose regimen of teplizumab B to the dialysis population. We look forward to continuing to make progress across these programs in the months ahead and we're excited to initiate the next clinical trial 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 pleased to report another quarter and full year of strong financial performance. I'll review the key financial results for 2023, as well as our financial guidance for 2024. 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-K for more detailed financial information. Starting with HEPLISAV-B, net product revenue grew 69% year-on-year to $239 million in 2023, another record year for the franchise.

We are also pleased with our continued trend in the margin profile for HEPLISAV-B with gross margin of approximately 76% in 2023 consistent with our guidance of mid-70s percentage for the full year and significant improvement compared to about 68% in the prior year.

Looking forward, we expect gross margins of approximately 80% for the full year 2024, which is consistent with our long-term expectations and margin profile for this brand.

Other revenue was $19 million in 2023 compared to $9 million in the prior year period, representing revenue related to the plague vaccine program in collaboration with and funded by the US Department of Defense.

The increase was primarily driven by the advancement into a nonhuman primate challenge study, as well as continued progress throughout our Phase 2 clinical contract for the vaccine candidate. Turning to our expenses.

Research & Development expenses for 2023 increased to $55 million, compared to $47 million in the prior year period with the increases reflecting continued advancements in our clinical and preclinical development programs.

Selling, general and administrative expenses for 2023 were $153 million compared to $131 million in the prior year period with the increase primarily driven by higher compensation and related personnel costs and an overall increase in targeted commercial investments designed to drive HEPLISAV-B market share and maximize the opportunities presented by the ACIP universal recommendation.

These results generated a GAAP net loss of $6.4 million in 2023 compared to a GAAP net income of $293 million during 2022. Moving to the balance sheet.

We ended the year with cash, cash equivalents and marketable securities of approximately $742 million, which we believe is sufficient to progress our current pipeline assets and support our organic base business without the need to raise additional capital. Turning towards 2024, we are providing the following full year financial guidance.

Coupled with that the net product revenue is expected to be between approximately $265 million and $280 million including approximately $3 million in ex-US sales through our commercialization agreement with Bavarian Nordic in Germany. We expect HEPLISAV-B gross margin of approximately 80% for full year 2024.

We expect R&D expenses to be between approximately $60 million and $75 million.

We expect SG&A expenses to be between approximately $160 million and $180 million and we also expect to be cash flow positive from the full year ended December 31, 2024, reflecting our continued discipline towards allocating capital to drive top-line revenue growth, while thoughtfully advancing our research programs.

In closing, we believe that with our strong financial profile we are well-positioned to drive sustainable growth in our HEPLISAV-B business, capture 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 in 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. And 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..

Hi, good afternoon. Thanks for taking my questions. Congrats on a great 2023. Last year, you just wanted to visit last year, and you initially gave guidance of, there was lower 165, 185, something like that. And throughout the year, you raised it 20%, over 20% with subsequent updates.

What were the factors you think that drove greater than expected sales from your initial point last year? Was it greater growth of the total market or market share gains? Just kind of wondering what factors might influence where your guidance goes from today in 2024?.

Hey, Matt, thanks for the question. I think we have to remember 2023 was the first year -- first full year coming out of both reconciliation of pandemic demand as well as the ACIP universal recommendation.

So one of the things we said, I think we were pretty clear about this, as I recall from our prior earnings calls, is that the market growth in 2023 outpaced our original expectations when we originally provided guidance earlier in the year. So we also had fairly successful growth in market share throughout the year.

And so those two factors were dominated by better market growth than originally projected..

Yeah, okay, thanks, Ryan.

And does your guidance for this year include any contribution from the dialysis segment?.

Yeah. I mean, we don't really provide guidance segment by segment. So we want to stay true to that. Our guidance for the year takes into account a lot of different puts and takes on how the year can evolve. So we're not going to be able to comment on one specific segment..

Okay. Great. Thanks for taking my questions..

Thanks, Matt..

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

Hey, guys, thanks for taking the question and also congrats on the 2023 growth. I wanted to drill down a little bit into that comment you made on little growth in the Hep B market in Q1.

Do you still have an opportunity to grow share in Q1? To what extent is share growth tied to overall market expansion, I guess? And then secondly, what are your expectations on the regulatory requirements for plague beyond the Phase 2 and the NHP studies this year? What do you expect from regulators and what do you expect from DoD?.

Hey, why don't we take the -- hey, thanks, Jon. Thank you for the questions. I'm going to have Don tap me a first question and I'll pick up the second one..

Hey, Jonathan. Yeah. Regarding share, actually, we're excited about our ability to continue to take market share. This quarter is no different. It's one thing to be consistent around the ability to take market share. So we like our position and our ability to take market share in this first quarter, even with the market being what it is..

And then the second question regarding the plague plan, the regulatory plan. I think it's important to know the reason we're doing the non-human primate studies is because that's a key part of the regulatory path for a product like this utilizing animal.

And so what we don't know yet is the specific path on whether or not there will be additional work required to satisfy the filing needed under that pathway with the agency. Rob, I don't know if you have any other comments you want to make around plague..

No, I think you covered it. I don't think at this point we know what will be required, say, for an EUA versus a full approval. Not at this point..

Make sense..

And a little bit, the data will also be an important aspect of that. So we really need to see that data before we can confirm the pathway..

And then just one more on gross margin.

You said 80% plus for HEPLISAV, but how does the potential DoD collaboration revenue and other revenue line tie into that? Could total gross margin, overall gross margin still be in the mid-80s and higher?.

So the guidance -- so thanks for the question. The guidance is approximately 80% for the full year for HEPLISAV. Our other revenue line item is predominantly our plague contract reimbursement, which doesn't carry significant margin, or sorry, significant cost of goods at all. It doesn't carry any cost of goods at all.

So yes, to the extent we continue recognizing, which we expect to continue recognizing other revenue through that contract, our total company gross margins would be slightly higher than that 80%..

Thanks so much..

Thanks, Jon..

Thank you. One moment for our next question. Comes from the line of Paul Choi with Goldman Sachs. Your line is now open..

Hi, team. Good afternoon, and congrats on the strong finish to 2023 from us as well. I want to maybe just ask on your thinking with regard to the guidance.

And as you think about the macro economic environment we're in and on people's price sensitivity and sensitivity in terms of thinking about healthcare spending versus the high-inflation environment, how do you think about maybe sort of the puts and takes of that in terms of demand growth over the course of the year? And would that – is that something you're thinking about in terms of freight trimming your guidance? And then I had a follow up on capital allocation..

Thanks for the question, Paul. Our guidance obviously is very specific to the market dynamics trend or vaccination and it's we don't see some of those macro factors having a big impact here at all on the advertising market. And it's a very the reimbursement for that segment is incredibly well.

There's first dollar coverage required under the Affordable Care Act. So we think we're in a good position as it relates to some of those macro factors to continue to grow the vaccine market through 2024 and beyond..

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..

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?.

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.

Thanks, Paul..

Ryan, thank you..

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

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..

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.

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..

Okay. Very helpful. Thank you..

Thank you, Ernie..

Thank you..

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..

Hey, this is Steve on for Ed White. Few questions.

For the shingles vaccine, do you have a expected timing to market?.

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..

Okay. Thank you.

And so there were no adjuvant sales this year, right?.

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

Okay.

And what about in 2025 and going forward?.

It's unclear. Depends on how the market demand and how the markets evolve and how our individual collaborator's products are utilized and the efforts they put beyond behind keeping up with the shifting landscape including stream managements. So obviously we'll be supportive of our partners and their initiatives.

We believe COVID vaccination will continue globally for the years to come and is an important product in the marketplace. And so we will be there to support them as needed..

All right. Thank you..

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

Hey, thanks for taking the questions. A couple of quick ones on the play. But are you going to announce the results of the non-human challenge trial and the Phase 2 at the same time later this year may.

Can you remind me are you making any cell-mediated immunity assessments in the Phase 2? And do you think those might be important? Any thoughts on that? Thanks..

I'll take the first one and then I'll ask Ron to follow up on the second. One of the things you have to realize with the study with funded by the DOD is this is data that has we had orbital or duty partners on the release -- that data release.

And so that has not been clarified yet on exactly what the opportunity will be to show that data and what form for either trial.

So we need to basically complete the trials first roll in, will be able make some top line comments like we have in the past but we don't have a data release plan across both trials together that will we will work to be able to provide as much clarity on how that program is progressing in partnership with the DoD.

Primary endpoint is antibodies that Rob would you please read any other commentary you have around cell-mediated immunity in the play program?.

Yes, the primary endpoint is looking at antibodies because that's been that's what DOD has used in previously. They've developed this vaccine on particularly with respect to looking at antibodies non-human primates and then applying those to humans. We aren't looking at cell-mediated immune your T cells in our in this Phase 2 study..

Thank you..

Thank you. At this time, I'd like to hand the conference back over to Mr. Ryan Spencer for closing remarks..

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 overall. We look forward to updating you on our progress focused on protecting the world against infectious diseases. Operator, you may end the call..

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