Good day, ladies and gentlemen, and welcome to the Dynavax Technologies' Second Quarter 2024 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..

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, our Chief Financial Officer. Earlier today, Dynavax released financial results for the second quarter ended June 30th, 2024.

Copies of the press release and the 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 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 our second quarter 2024 results. We've achieved another record quarter for HEPLISAV-B net product sales as we strengthened our leadership position in the U.S.

adult hepatitis B vaccine market, marking continued year-over-year market share gains for the total market and in key market segments. Based on our strong results in Q2 and the continued strengthening of the hepatitis B vaccine market across Q2 and into early Q3, we are reaffirming our HEPLISAV-B product revenue guidance for the full year 2024.

Longer-term, we are highly optimistic about the adult hepatitis B vaccine market of over 130 million eligible patients, which is one of the largest addressable patient populations for vaccines in the U.S.

We expect the market opportunity for HEPLISAV-B to grow to over $800 million by 2027, with continued growth in both market share and market size through the end of the decade.

We also anticipate long-term demand for HEPLISAV-B beyond 2030 as a result of the continued penetration of the unvaccinated cohort as well as expanding market share, providing a substantial long-term revenue opportunity for HEPLISAV-B.

For our pipeline development, we are pleased to have recently initiated our Phase I/II trial for our novel shingles vaccine program and remain excited for several upcoming milestones, including readouts from the single study as well as our Tdap and plague vaccine programs expected across 2024 and 2025.

In addition to this progress and bolstered by our strong financial position, we continue to evaluate strategic opportunities to grow beyond our internal organic pipeline within the infectious disease space, which we believe would enable us to further diversify our product portfolio and create future commercial opportunities.

We look forward to providing updates on these efforts in the future. I'll now turn the call over to Donn and Rob, who will provide more details on the HEPLISAV-B results and our pipeline progress, respectively, before Kelly reviews our financial results for the second quarter.

Donn?.

retail pharmacy and integrated delivery networks or IDM. In retail, HEPLISAV-B's second quarter estimated market share increased to approximately 59% compared to approximately 45% during the same period last year. For IDN, HEPLISAV-B's estimated market share increased to approximately 56% compared to approximately 53% for Q2 last year.

During the quarter, several top national retail chains and many large IDN systems, established hepatitis B-focused initiatives and campaigns to increase hepatitis B vaccination.

We are encouraged by the focus and commitment of these customers and expect this momentum to continue into Q3 as healthcare providers continue to mobilize around the opportunity of hepatitis B vaccination. We remain confident in the long-term expansion of the U.S. hepatitis B vaccine market.

In early 2022, when the ACIP universal recommendation went into effect, we provided five-year guidance, and we expect the HEPLISAV-B market opportunity to be over $800 million by 2027, with HEPLISAV-B positioned to achieve a majority market share.

We remain confident in that five-year guidance and expect continued hepatitis B market expansion and HEPLISAV-B market share gains through the end of the decade. Beyond 2030, we expect the market to be substantial due to the continued penetration of the remaining large unvaccinated adult cohort.

We look forward to providing more specific longer-term guidance by the end of this year. In summary, we are reaffirming our confidence in the outlook for HEPLISAV-B both for 2024 and long-term. We expect HEPLISAV-B to strengthen this position as a clear market share leader in the expanding hepatitis B vaccine market.

We are very proud of our commercial team's success and are excited to help build on the momentum seen in Q2 for the remainder of 2024. I will now turn the call over to Rob to take you through our clinical pipeline..

Thank you, Donn. I'm excited by the progress we're making with our innovative vaccine pipeline, starting with our shingles vaccine program, Z1018. As a reminder, we believe there's an opportunity to develop an improved shingles vaccine given the challenging tolerability profile of the current market-leading product.

In the second quarter, we initiated a randomized active controlled dose escalation multicenter Phase I/II trial to evaluate the safety, tolerability and immunogenicity of Z1018 compared to an active control in approximately 440 healthy adults aged 50 to 69 years.

Key objectives of the trial include selecting the optimal glycoprotein E dose level and dosing schedule as well as adjuvant formulation for further clinical development. The Phase I/II trial will be used to support validation of a patient-reported outcome measurement tool to differentiate Z1018 on tolerability and to support potential label claims.

We anticipate reporting top line immunogenicity and safety data in the second half of 2025, including a comparison of CD4-positive T cells one month after the second of two vaccine doses. Turning next to Tdap-1018 program.

This is an investigational vaccine candidate 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-bias immune response.

We're evaluating the persistence of Tdap-1018-induced pertussis immunogenicity through a long-term follow-up study of participants who completed a Phase I trial of a booster dose of Tdap-1018 compared to an active control. The extension study will capture data for participants up to three years following initial vaccination.

Results from the Phase I extension study are expected in the fourth quarter of 2024. These data will provide us with a view of how the Tdap -1018 immune response over time compares to the active control and will help establish our views on the potential benefits that can be achieved with this vaccine candidate.

For our plague vaccine program, which is in collaboration with and funded by the U.S. Department of Defense, we anticipate providing a program update based on results from both our Phase II clinical trial and the nonhuman primate challenge study in the fourth quarter of 2024.

We're also focused on addressing FDA comments regarding our sBLA for HEPLISAV-B hemodialysis dosing regimen. We intend to meet with the FDA in the second half of 2024 as part of the standard regulatory process to discuss pathways to amend our sBLA with additional data to support potential approval of the FORTIS regimen.

We're pleased with this progress across our pipeline, and we look forward to executing on these upcoming milestones in the coming months. I'll now turn the call over to Kelly to review our financial results..

Thank you, Rob. Before I get started, a reminder to please refer to our press release and Form 10-Q filed earlier today for more detailed financial information.

I'll walk through the financial highlights for another strong quarter, underscored by record HEPLISAV-B net sales of $70 million, a 24% year-over-year increase, and a 47% sequential increase compared to last quarter, putting us on track to achieve our guidance for the full year 2024.

We believe this progress is a testament to the effectiveness of our overall brand plan and highlights the strength of our sales deal team, combined with successful marketing campaigns across multiple channels, including retail. HEPLISAV-B fee gross margin improved to 83% in Q2 2024 from 76% in the prior year quarter.

This margin expansion is consistent with our guidance of approximately 80% for the full year 2024 and the result of highly efficacious capital investments in our manufacturing process combined with improved scale over time.

Other revenue was about $4 million for the second quarter, representing revenue related to the plague vaccine program in collaboration with and funded by the U.S. Department of Defense.

Turning to our expenses, eesearch and development expenses were $15 million for Q2 2024 compared to $13 million for the prior year period, with the increase reflecting important progress throughout our discovery, preclinical, and clinical pipeline.

Selling, general, and administrative expenses for the second quarter of 2024 were $42 million compared to approximately $37 million for the prior year period. The increase was primarily driven by sales -- by our sales force expansion in the second half of 2023 and other high ROI investments driving the growth of our HEPLISAV-B franchise.

Sublease income was $2 million in the second quarter of 2024 and as a reminder from last quarter's call, we expect to record approximately $5 million of net sublease income for the full year 2024. These results generated net income of $11 million in the second quarter of 2024 compared to $3 million during the prior year period.

Moving to the balance sheet. We exited the second quarter of 2024 with cash, cash equivalents and marketable securities of approximately $736 million, which was a $12 million increase during Q2.

We remain on track to achieve our cash guidance for the year and continue to believe that we have sufficient capital to prosecute our organic pipeline without the need to access the capital markets. Based on our strong execution year-to-date, we are also reiterating all of our full year 2024 financial guidance.

For our full guidance framework, please consult our press release earlier today. In closing, we are excited to report another strong quarter, consisting of record quarterly revenue for HEPLISAV-B, improved product gross margins and advancing pipeline and a very robust balance sheet.

I'd now like to turn the call back over to Ryan for closing comments..

Thanks Kelly. I want to take a few moments to provide additional context and reflect on the progress we are making beyond the results from this quarter. I'm personally very proud of what this company has accomplished over the last few years and how that sets us up to drive the next leg of growth.

We've demonstrated exceptional execution commercializing HEPLISAV-B and delivered a profitable brand with a long-term growth profile, which provides a strong foundation for us to continue to build on. I'm proud of our team's success in a market that has long been dominated by big pharma.

Beyond HEPLISAV-B, we have managed to stay both disciplined and agile, allowing us to respond to opportunities and manage our risks, while advancing new products into the clinic.

We've been actively evaluating strategic opportunities for growth, but remain committed to applying disciplined business judgment, avoiding an implementation to take action for the sake of the perception of progress. Beyond our financial position, we have built a high-performing team focused on strategic leadership and professionalism.

We believe this provides us the tools we need to grow our business and maximize our impact to benefit all of our stakeholders, including patients, investors, and employees as we aim to position Dynavax as a leading infectious disease company. Thank you, everyone. Operator, we'd now like to open the Q&A portion of today's call..

Thanks for taking my questions and giving us the update here across the upside of the programs.

I was wondering maybe if you could give us a little bit of your expectations around market share, maybe by the end of this year or when you think you will break that kind of 50% mark in market share? And then as we think about some of the seasonality throughout the rest of the year, Kelly, maybe you can help us on -- should we assume a similar percentage of total year sales in Q3 and Q4 this year as we saw last year? And Kelly welcome back..

Thanks, Matt. I'll take the first one on market share. Obviously, we don't provide guidance at that level of detail.

So, I'll just have to refer back to some of our general comments related to 2027 on the long-term guide that we expect to have a majority share at that period in time, but we haven't provided any guidance on market share that's more refined than that.

And as it relates to seasonality, Kelly, do you want to take that?.

Sure. Thanks for the warm welcome back, Matt. So, as a reminder, we did reiterate our guidance, our net sales guidance for the year between $265 million to $280 million.

With respect to the seasonality that we've previously guided to and have sort of started to see throughout this year, we are still anticipating that Q4 contraction at the higher end of historical ranges. So, in that 15%, I think last year, we said we made 15% to 20%.

We are expecting that to come into the about 15% range this year, again, that's sort of how we expect Q4 relative to Q3. So hopefully, that's helpful. We do still, of course, expect Q3 to be a very strong quarter as well..

Okay, great. Thanks for taking the questions..

Thanks, Matt..

Thank you. Our next question comes from the line of Phil Nadeau from TD Cowen. Phil, your line is now open..

Thanks for taking our questions. One commercial, one pipeline. On commercial, you reiterated your guidance for $800 million market in a few years.

Can you talk about the data points that are accumulating that continue to give you confidence in that market growth? I think for most of us, it's a little hard given the noise around contraction in the market, some quarters and growth others.

So, what gives you confidence that all is on track to hit that ultimate market size?.

Yes, I'll make a couple of high-level points. And Donn, if you have any other details to add, please do this. Donn may reminded us that back in 2022, we projected out the market to be $800 million by 2027 based on our modeling of increasing coverage rates as a result of the ACIP universal recommendation.

And we continue to reiterate that because we're tracking towards those projections as we've progressed over the last few years. Donn, I don't know if you want to elaborate all on--....

I mean the only additional color would be those rates that we kind of put into our forecast are kind of in line with other vaccines and so other vaccine analogs. So, as Ryan mentioned, we see that occurring, and that gives us the confidence to kind of reiterate that guidance long-term.

But again, just looking at the market, looking at what happens with other vaccines, and we believe hepatitis B vaccination will follow that similar path..

So, Phil, I think the data points you can look at are, one, the historical size of the Hep-B market and how it's grown since 2022 recommendation, along with analog being products that have recommendation changes and you'll see in those products point Tdap, for example, or flu that you'll have multiple years of progress made towards increasing vaccination coverage rates..

Got it. Okay. Maybe actually one follow-up on commercial. There's a lot of controversy in the COVID vaccine and RSV vaccine space because of recent trends there. COVID has been a little disappointing,. RSV obviously had the recent recommendation or not recommendation for any more vaccination.

So, there seems to be some concern that those vaccines won't be as heavily utilized next season as they had in this past.

How does that figure into your expectations for seasonality for HEPLISAV? Is it too early to tell? Or is there some reason to think maybe 2024 to 2025, that respiratory virus season won't be as impacted on HBV vaccines as the past?.

Yes. So, a couple of comments on the landscape. One, COVID remains still a very large product. So, you're right, I think you could have some -- there's a comparison of expectation versus utilization, but it's still relatively highly utilized annually.

And RSV is going to be lower given the lack of recommendation for annual boost, those are both tailwinds for HEPLISAV. Donn, do you want to maybe just provide a little bit of color on, in particular, the retail pharmacy trends that we have seen or could see as we progress as it relates to plus one options..

I think it goes down to that, Phil, and the fact that it provides more vaccination opportunity, quite frankly, for patients as they originate in pharmacy this fall season into winter season. So, again, to Ryan's point, the tailwind, it's an opportunity. Our retail partners see it as such.

And so for hep-B, it is an opportunity because, again, it provides additional origination vaccination opportunities this season, and we factored that in as we think about this year and beyond..

And to be clear, although RSV will be utilized less, that took an arm is someone originated for flu or COVID. Now they have - there's an opportunity to be a different vaccine to be administered..

Correct..

Got it. Okay. And last question on the pipeline. You mentioned C-4 levels are going to be assessed in the Z-1018 trial.

Can you give us some sense of what you hope to see? What would you consider encouraging that will prompt further investment versus what would be discouraging in Dynavax's eye?.

Sure, Rob, why don't you take that?.

Yes. What we're looking at, we're looking at a number of different antigen levels in different combinations with adjuvants as well as different dosing regimens. And what we anticipate is identifying the best to move forward, which would be one that provides similar levels of CD4 accounts that we see with Shingrix..

Got it. Thanks for taking our questions..

Thank you. Our next question comes from the line of Jon Miller from Evercore. Jon, your lines is now open..

Yes, thanks for taking my question.

I guess one on market share here, and I know you sort of talked about this a little bit, but what drives the next leg of market share here? Obviously, you've had good year-on-year growth for the past handful of quarters, but does it feel like it's stable, plus or minus a couple of percent, and the comps -- will year-on-year comps get tougher going into second half year? So, what drives the next level of HEPLISAV growth from here?.

Yes. So, a couple of things. I'll hit at a high level again, Donn, if you want to add to it, please do. But we continue to have customers where we can expand utilization. So, customers don't move as a block necessarily in the IDN space, so you'll get the largest clinics and you can continue to expand there.

I think the other element of this is a disproportionate share of growth. So we do believe the HEPLISAV will continue to capture a disproportionate share of the market expansion, which will also help overall market share..

Okay. Okay, sure. Then the other question, I guess, is it looks like from a gross margin perspective, you're more or less hitting your guidance this quarter.

As I think quarter-to-quarter, how much noise is there in gross margin now that the big efforts to improve that over time are on board and you're reaching the realm you are hoping to get to?.

Sure. So, we'll continue to see some minor fluctuations quarter-to-quarter and some variability quarter-to-quarter just because of timing of just manufacturing processes.

But I think in terms of order of magnitude, what we've seen these last couple of quarters is probably what we can expect to see going forward, which is why we provided the -- to your point, the 80% estimated gross margin for the year as our guidance..

Great. And then maybe last one for me. Just more about the phrasing of how you're -- some of your guidance reads. You're guiding for cash and equivalents at year end to be greater than it was at year-end 2023. And I noticed you're not talking about cash flow, you're not talking about particular profitability numbers.

It's specifically cash plus equivalents guidance.

Does that imply that BD is less likely before the end of the calendar year?.

That guidance, Jon, just to be very clear, is on our current existing business, obviously, to the extent that we had significant deployment of capital for a BD opportunity that would impact that guidance..

Yes, makes sense. Thanks very much..

Thank you. Our next question comes from the line of Paul Choi from Goldman Sachs. Paul, your line is now open..

Hi, good afternoon and thank you for taking our questions. My first question is also on the guidance and maybe directed to Kelly and Donn. As you think about the guidance for the back half of the year, obviously, you've historically been weighted to 3Q versus 4Q.

But I guess it seems like as we look at recent prescription trends through July, while up versus the tail end of 2Q, it seems like there's going to be a bit of a heavy lift to make the midpoint or upper end of your guidance.

So, I guess the question is, based on what you're seeing in the marketplace right now, are you more comfortable with the lower end of the guidance you provided versus the midpoint? That's my first question. And then second, with regard to the plague program, you guys did mention that you'll get -- provide an update in 4Q.

But assuming the data is positive there, can you maybe just remind us if that triggers any milestone with regard to that program? And welcome back, Kelly as well..

Thank you. I'll take the first one and then Donn definitely will add in some details. which is as we think about guidance, I think we certainly believe that we have plenty of scenarios that will support the upper end of the range. So, we keep the guidance in terms of a range because there are uncertainties.

So, I think a couple of things that we're really excited about headed into Q3 and even Q4 have already been highlighted on this call. So, for example, some of the retail pull-through that we've seen, we continue to see that.

And we also have a really strong response to our personal promotion and then also, of course, some of the opportunity that was highlighted around the recent RSV recommendation, certainly, that opens up an opportunity for us. Maybe I'll hand it over to Donn to add any other color..

Yes.

Yes, Paul, just regarding looking into Q3, I mean, to Kelly's point, we've said it's already -- we're excited with what we see, especially with the new retail pharmacy segment, actually the behaviors that are happening and occurring by our partners, really save themselves up for a fairly robust back half of the year, taking advantage of opportunities and patient origination, as I mentioned before, with the RSV example, infrastructure is in place, communications in place.

And so that's where we feel very good about where we're going at when we reaffirmed our guidance for 2024..

And then Paul, on the plague program, there's no defined milestone structure as it relates to that program. That is a -- it's a duty-funded program that would the upside value there would be future product sales of either 1018 or if we ended up being responsible for the whole product.

So, we'll probably update on the program in Q4, which would include any future expectations around advancement and funding..

Got it. Okay, thanks for the clarity. Thank you very much..

Thank you. Our next question comes from the line of Roy Buchanan from JMP Securities. Roy, your line is now open..

Follow-up on a lot of the guidance question. Just the longer term guidance that you mentioned providing later this year. Can you maybe talk a little -- give us a preview maybe of what that's going to look like? Is that 2030, 2035, 2040, any granularity on when you might give us that guidance? Yes, thanks..

Yes. Hi Roy.

As you heard in some of the qualitative statements we made today around a little bit of an indication of what we expect beyond 2027 with continued market growth and continued market share, we are looking to be able to update longer term guidance to focus on providing color as to where we see the peak opportunity and then some context for the shape of the herd post peak.

So, we're refining that work right now, which is where we feel confident in continued growth on 2027, and we'll refine that a little bit more and provide a bit more quantitative update later this year..

Okay, great. And did anything change? I guess not, but -- or have you just seen enough data at this point to be able to be confident in making these longer term projections? Thanks..

Well, it kind of goes back to the discussion we had earlier in the Q&A session that we put out five-year guidance in 2022, and we wanted -- which we felt comfortable with at the time, and we think we need to continue to provide our view of the long-term opportunity as we have additional information to influence it.

So, the last few years have provided us insight that we invite to reflect in our long-term guidance..

Makes sense. Thanks..

We have no further questions at this time. I would now like to turn the call over to Ryan Spencer, CEO, for closing remarks. You may begin..

Thank you, operator and thank you all for joining us today. We appreciate your interest in Dynavax. We are excited about our recent accomplishments and the strength of our position. 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. This concludes today's conference call. You may now disconnect..