Good day ladies and gentlemen. And welcome to Dynavax Technologies' First Quarter 2023 Financial Results Conference Call. As a reminder, this conference 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 of Investor Relations and Corporate Communications. You may begin..

Thanks you, Norma. Good afternoon and welcome to the Dynavax's first quarter 2023 financial results and corporate update conference call. In addition to our press release issued today, a supplementary slide presentation that accompanies today's call is available in the Events section of our 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, future expected market share and related growth rates and related ACIP recommendation impacts on each financial guidance and trends including revenue, profitability, insufficiency of current capitalization, and may results of clinical trial starts and data readouts and for 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. Joining me on the call today are Ryan Spencer, Chief Executive Officer; Donn Casale, Chief Commercial Officer; Rob Janssen, Chief Medical Officer, and Kelly MacDonald, Chief Financial Officer. I'll now turn the call over to Ryan..

Thank you, Paul. And thank you all for joining us today. We're excited to update you on our continued progress in the first quarter as we execute across our core strategic priorities. First and foremost, we're focused on driving growth for our commercial product HEPLISAV-B our adult vaccine for hepatitis B.

In the first quarter, we're pleased to achieve record quarterly net product Revenue once again for HEPLISAV-B and continued market share gains, both in total market share and in the key market segments that are expected to drive the long-term growth. The tremendous results this quarter even exceeded our own expectations.

We are encouraged by the continued market adoption of HEPLISAV-B to in part by the expanded ACIP recommendation for adult Hepatitis B vaccination, and look forward to demonstrating continued revenue and market share growth this year. Last year, HEPLISAV-B revenue doubled compared to 2021.

And we anticipate continued annual revenue growth for HEPLISAV-B in 2023 in the range of 30 to nearly 50%. Our Q1 revenue increasing 109% compared to Q1 of last year, we are already on track to achieve a fourth year of record revenue for HEPLISAV-B. Donn review or commercial progress in more detail in a few minutes.

We continue to build on the strong executional foundation made in 2022 to further advancement of our pipeline, as we progress our three adjuvants vaccine clinical stage candidates for Tdap, shingles and plague and continue to identify new opportunities to leverage CpG 1018 in our preclinical efforts, both internally and through our collaborations.

Rob will walk through our expected progress for clinical programs this year in detail later on in the call. Based on our strong execution, we are in a financial position that enables us to support our efforts to maximize the HEPLISAV-B opportunity while making the appropriate investments to advance our clinical stage portfolio.

In addition, backed by the continued HEPLISAV-B growth and our strong cash position, we are actively working to identify and review strategic opportunities to accelerate our growth.

Our initial prioritization of external opportunities includes the following two categories, commercial or late-stage assets in the vaccine space to leverage our expertise in the field and our fully integrated capability and high synergy commercial assets within the infectious disease space that would broaden our focus to include therapeutic modalities outside of vaccines.

We remain focused on a disciplined capital allocation strategy in our efforts to generate significant value and accelerate growth. And we look forward to providing updates on this front in the future. I'll now turn the call over to Donn to provide more details on the tremendous HEPLISAV-B performance in the first quarter..

Thank you, Ryan. I'm excited to share more details about the very strong performance for HEPLISAV-B in the first quarter, and our continued progress in capturing market share for the brand. As a reminder, HEPLISAV-B is the first and only FDA approved adult hepatitis B vaccine that allows series completion with only two doses in one month.

Series completion is essential for high levels of protection. In an era of universal Hepatitis B recommendation, two dose of HEPLISAV-B can make series completion easier and protect more patients faster than a three dose regimen. As Ryan stated, HEPLISAV-B performance in the first quarter exceeded our expectations.

In the quarter net product revenue for HEPLISAV-B savvy group 109% year-over-year. This significant revenue growth in the U.S. was driven by several factors. First, the Hepatitis B market continues to grow in the U.S. following the ACIP Universal Recommendation for Hepatitis B vaccination.

The ACIP's recommendation that all adults aged 19 to 59 receive Hepatitis B vaccination significantly expands the number of adults in the U.S. who are recommended to be vaccinated. Hepatitis B now has the second highest addressable adult population for vaccination in the U.S., more than shingles and pneumococcal vaccination and is second only to flu.

This represents a large and growing market opportunity. We continue to believe this recommendation will be a significant catalyst for growth and estimate the hepatitis B market opportunity in the U.S. could grow to over $800 million by 2027. During the first quarter we observed hepatitis B vaccine market growth of approximately 45% year-over-year.

This significant market growth was due to a return to routine healthcare operations, plus market expansion as a result of the ACIP Universal Recommendation. The second factor underlying HEPLISAV-B's performance is the continued positive trend towards securing a majority market share within the expanding Hepatitis B market.

We continue to demonstrate gains and market share quarter-over-quarter and estimate that HEPLISAV-B's total market share increased to approximately 37% compared to approximately 26% at the end of the first quarter last year, and only 14% in Q1 of 2021.

The 37% market share in q1 also demonstrated sequential market share growth from Q4 of last year where HEPLISAV-B had a 35% share. We continue to be very encouraged by this positive trend towards capturing a majority of market share by 2027.

The third factor driving growth for HEPLISAV-B is strong performance in two critical market segments; retail pharmacy, and integrated delivery networks or IDNs. For the retail segment, HEPLISAV-B's market share increased to approximately 49% in Q1 compared to approximately 20%. At the end of the first quarter of last year.

We have made tremendous progress with the top 10 retail pharmacy chains in the U.S., characterized by increases in initial purchases and reordering at higher volumes. With several large national chains making HEPLISAV-B their preferred adult hepatitis B vaccine.

Additionally, during the quarter, we initiated collaborative marketing initiatives with three of the top four national retail chains, demonstrating the continued excitement around HEPLISAV-B and the ACIP universal opportunity.

For IDN, at the end of the first quarter, HEPLISAV-B's market share increased to approximately 49%, compared to approximately 33% at the end of the first quarter last year.

Similar to retail in the IDN segment, we are continued to see strong conversion from large customers that have adopted the ACIP Universal Recommendation, driving meaningful increases in their hepatitis B purchases that continue to exceed 2019 pre-pandemic levels.

We believe the retail and IDN segments will see them do most of the anticipated market growth from the ACIP Universal Recommendation. Both segments have the required institutional control infrastructure capabilities and patient volumes that can drive universal uptake.

We expect these two segments will represent approximately 60% of the Hepatitis B market by 2027 compared to proxy 44% in 2022. We are well positioned in both segments with HEPLISAV-B now making up approximately 50% of the market share across these two segments.

We have established long-term relationships with key vaccine decision makers, along with a deep understanding of the buying process and operational levers that can help us drive ACIP Universal Recommendation uptake.

This exciting progress has supported our shift in strategy for a market share only approach to increasing our focus on market expansion in the retail and IDN segments.

In summary, we are very encouraged by our continued progress and momentum in the key segments of retail and IDN, both of which significantly contributed to the performance of HEPLISAV-B, exceeding our expectations in the first quarter.

In 2023, we forecast the Hepatitis B market opportunity will grow 15% to 25% from 2022 levels, and exceed 2019 utilization, showing not only a complete rebound from pandemic-related disruptions of the market, but continued further growth being driven by the ACIP Universal Recommendation.

And in addition to total market growth, we expect HEPLISAV-B will continue to increase its market share across all segments, most notably in retail and IDN.

I continue to be proud of our team's strong commercial execution and we remain very confident in our ability to continue this momentum as we strive to capture a majority market share for HEPLISAV-B. I will now turn the call over to Rob to take you through our clinical pipeline..

Thank you, Donn. We're focused on advancing an innovative and diversified vaccine pipeline leveraging our CpG 1018 adjuvant with proven antigens. Our goal is to build novel vaccine portfolio of best-in-class products. Next, we're currently advancing clinical programs for three adjuvant in vaccines, Tdap, shingles, and plague.

We're also exploring multiple innovative preclinical and discovery efforts with leading collaborators. Starting with our tetanus, diphtheria and pertussis or Tdap program.

We believe our CpG 1018 adjuvant has the potential to improve the durability of protection against pertussis by redirecting T-cells and enhancing protective antibody responses in a booster vaccine. Last year, we completed a Phase 1 clinical trials evaluating an improved Tdap vaccine that utilizes our CpG 1018.

Adjuvant adult and adolescent safety data from this study demonstrated the vaccine candidate was well tolerated without observed safety concerns. Adult immunogenicity results were consistent with our expectations and support continued advancement of the vaccine candidate. This year, we plan to make important progress with the Tdap program.

We're completing a non-human primate pertussis Challenge study that was designed to assess the impact on prevention of disease and nasal colonization, as well as T-cell responses. Data are anticipated in mid-2023. We also plan to discuss the clinical and regulatory pathways with the FDA this year.

We expect to provide an update on the next steps for this program, including our planned human Challenge study following that interaction. We also continue to advance our Shingles vaccine program.

We believe the CpG 1018 adjuvant mechanism of action is ideal for an improved shingles vaccine due to its demonstrated good tolerability and its ability to generate high levels of both antibodies in CD4 positive T-cells, which are key in controlling reactivation of the Zoster virus and preventing shingles.

In January, we reported top-line results from our Phase 1 clinical trial designed to evaluate our investigational shingles vaccine, utilizing different regimens of CpG 1018 adjuvant. The Phase 1 results have been accepted for an oral presentation at the 2023 Annual Conference on Vaccinology Research or ACVR on June 6.

With these data in hand, we plan on discussing the regulatory path forward with the FDA this year. So over the course of the year, we expect to complete GMP manufacturing of GE antigen to support initiation of a Phase 1/2 study in early 2024. This study will evaluate various dose levels of GE plus CpG 1018 adjuvant. Moving on to the plague program.

We're conducting a Phase 2 trial evaluating the immunogenicity safety and tolerability of a two dose rF1V plague vaccine candidate adjuvant with CpG 1018. This is a collaboration with and funded by the U.S. Department of Defense or DoD.

The CpG 1018 adjuvant vaccine candidates mechanism of action has the potential to speed up time to protection with fewer doses compared to the three dose vaccine under development by the DoD. In January, we successfully completed part one of the clinical trial.

Both CpG 1018, adjuvanted arms met the part one primary endpoint by demonstrating a greater than twofold increase in antibodies over the LM adjuvant and control arm after two doses. The DoD approved continuing to part two of the Phase 2 program. And we're pleased to announce today that we recently completed enrollment in Part 2.

Top-line data are anticipated in 2024. The advancement of our clinical candidates is a core priority. We're confident in our strategy to leverage the proven profile of CpG 1018 to develop new and improved vaccine candidates that provide significant opportunities to address important unmet medical needs.

I'll now turn the call over to Kelly to review our financial results..

HEPLISAV-B net product revenue to be between $165 million to $185 million; research and development expenses of between $55 million to $70 million and selling general and administrative expenses to be between $135 million to $155 million. In closing, we continue to execute on our core priorities across the entire organization.

We are focused on strong operational and financial performance, as well as being extremely thoughtful in how we allocate our capital to accelerate growth.

Our strong capital position and commercial execution has provided us with strategic flexibility to identify and pursue external opportunities to complement our organic growth as we strive to deliver long-term value to our shareholders. We are excited about our progress to date. And we look forward to continuing to deliver on our goals for 2023.

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 questions and congrats on continued great launch and growth of HEPLISAV. GSK noted in their quarter an increase in hepatitis vaccine sales due to purchasing patterns in the CDC. And I wondered if any of that might apply to you all.

And then Donn, I like to focus on the retail on the IDN and seeing that grow as a way to grow the brand.

If you get picked up as a marketer and continue to grow market share in those brands will that spill over into some of the rest of the markets?.

Sure..

Okay..

No go ahead, Donn. Don't take away..

So, Matt, regarding your first question on CDC purchasing. That really wasn't something that impacted our revenue from a HEPLISAV-B perspective. We saw typical CDC purchasing in the public sector. So that wasn't really nothing that was of note for Q1 for HEPLISAV-B.

Regarding kind of that spillover impact as it relates to retail and IDN, we are seeing that impact, quite frankly in some of the other segments where we don't put as much promotional resource. We're seeing market momentum across various other segments.

And we do believe as we continue to take market share, it will certainly have an impact in these other segments as well..

Great, thanks, Donn. I guess maybe just one last question on the kind of synergy commercial assets that are not vaccines. Would that still be something prophylactic or it could be therapeutic as well? And I don't know if there's any other thoughts I can give around the size of the markets and other things. .

Thanks, Matt. Not necessarily prophylactic. And the point is recognizing that we want to broaden the aperture a little bit to have access to valuable transactions that can leverage our capabilities from a business platform perspective.

I mean, be going beyond prophylactic interventions, we still feel that we can leverage our corporate capability within infectious disease. So the focus is on higher synergies accretive deals that are commercial products..

Great, thanks for the questions..

Thanks, Matt. .

Thank you. One moment for our next question. Our next question comes from the line of Joshua Schimmer with Evercore ISI. Your line is now open..

Great. Thanks for taking the questions and congrats on the strong quarter.

I guess given how strongly it was and ahead of expectations, what are the uncertainties that have kept you from raising your guidance for the year?.

Thanks, Josh. Well, really just the first quarter, we did see really good growth in the market. We recognize we're sort of tracking up to Q1 to the midpoint and expect to be in the higher end of the range. But it's just too early in the year.

We'd like to have another quarter or so to be able to really find the market trends around growth before we change any guidance..

Got it? And what kind of seasonality are you expecting over the course of the year in terms of the overall market considering some of the various forces including the impact of the ACIP recommendations?.

Yeah, we know there's traditional seasonality. But Donn, you want to comment on how the ACIP growth could play into the typical seasonality that we see..

Yeah, Josh. To Ryan's point, we're going to see the seasonality we've seen in years past and particular Q4, given the holiday season. The one thing that certainly is on our radar and we'll continue to monitor is the launch of the RC [ph] vaccine certainly in the retail segment. But that being said, RC is going to be for 65 plus.

And when we think about retail and HEPLISAV-B and hepatitis B vaccination, there's a tremendous focus on 30 to 50 year old patients. So we'll have to continue to monitor that. But we'll see certainly that typical seasonality that we would seen in the past, particularly in the 10 Q4 [ph].

As it relates to ACIP, I don't know if that's going to impact seasonality per se. I think ACIP is going to continue to be a catalyst for continued growth, as we've said before, both in retail and in IDN..

Then last question, [Indiscernible] asset line increased by about $70 million in the quarter.

What drove that? What drove that?.

I can take that. So that's simply a reclassification of amounts associated with the Clover and CEPI arrangement from current to non-current..

Thanks very much..

Thank you. One moment for our next question. And the next question comes from the line of Madhu Kumar with Goldman Sachs. Your line is now open..

Hey, thanks for taking our questions. This is Rob on for Madhu. Maybe I could just ask a question about what do you expect the cadence to be of the entire market growing versus your market share growth. You guys saw a good market share growth over the past few years.

And I was wondering, how much of the future growth is going to be that versus the entire market growth with the ACIP recommendation now in place?.

Thanks, Rob. I think ultimately, market growth is critically important. I mean, we already reported that we're at 37% in our market share. We will continue to advance that take a majority share. But as you noted by some of our prior kind of disclosure, the market size being gone from $400 million to $800 million by 2027.

It gives you a pretty good clear order of magnitude on how important growth is. And I think the point that you make is we're not -- we're not at the point now where we would sort of project slowing of market share growth. But as you get more and more share, the next point does get harder to capture. So right now '23 is going to be pretty balanced.

But over the long term, market growth can be critical..

Thanks. .

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

Hey, thanks for taking the questions. Great quarter. First one is on dialysis and just can you review your views on the opportunity in that segment? Any reason for not expect the majority market share in the future.

And then looking at Slide 6, I mean, it looks like the total dollar amount doesn't really grow, the percent goes down by about half the market size goes up by about half. Why would HEPLISAV-B maybe not expand the dialysis opportunity? Thanks. .

Sure. Just to be clear, we really are favorable on our profile of dialysis within the adjuvant vaccine. So we're excited to be able to do the SPLA. And so we can begin to actually look to that segment. And we would expect to do pretty well there.

The reality is that market doesn't grow because right now it's solid with basically eight doses of the traditional vaccine. And the patient population isn't expected to grow their life it is in other segments. And so as HEPLISAV moves into that space, we think it'll do very well.

But it doesn't grow the market size because of the amount of doses used in that space compared with the amount of doses used, with HEPLISAV-B..

Okay, great. A few on the shingles. Not sure if you can tell us but if you can, that dose of CpG 1018 that you're going to go with and what levels of GE that you're going to explore? And just any other details on the trial design, maybe the plan size of the Phase 1/2. Thanks. .

Rob, do you want to take that?.

Sure. So we haven't made final decisions on either CpG 1018 dose. We do anticipate doing a dose escalation of at least three or four levels of GE.

But again, the final decisions on dose aspects of the study design haven't been made yet?.

Okay, great. Thank you..

Thank you. And we'll we will also work with the FDA this year to clarify the regulatory path forward and finalized potential trial sites..

Okay, perfect..

Thank you. One moment for our next question. Next question comes from the line of Ed White with H.C. Wainwright. Your line is now open..

Good afternoon. Thanks for taking my questions. With the market share growth we saw on retail this quarter, were there any new retail initiatives in the first quarter of this year? And do you have any plan for the rest of 2023? And I also want to get your thoughts on potential DTC advertising to drive retail sales..

Donn, you want to handle this?.

Sure. Yeah. So regarding retail initiatives, as you know, we've said this in the past initiatives are very critical in this segment. And so a lot of Q1 was setting up Q2, as it relates to initiatives. We are strategically placing our initiative in the second quarter to get out ahead of the flu season.

As I mentioned, during my comments, we have various initiatives, with three of the top four retail chains throughout the country, that give us a lot of confidence, obviously, going into Q2 and the rest of the year. And so those initiatives are critical. But those initiatives also tie in to the second part of your question, which is direct-to-consumer.

Part of our strategy with DTC is partnering with retail and leveraging their capabilities, their advertising capabilities to reach their customers and their consumers. We believe those channels bring much more credibility when we're talking about ACIP Universal Recommendation in HEPLISAV-B.

So that's our strategy is to leverage retail in their infrastructure to get to their patients and their consumers throughout the year..

Thanks for the question. And just to put a finer point on it, DTC is very large. We have a very focused approach to DTC that we think are very effective..

Okay, thanks. And just a question on Europe. So you received marketing authorization in Great Britain in April. And I just wanted to get your thoughts on the opportunity in Europe for perhaps just 2023 or and beyond that..

Yeah, I mean, we did just receive the authorization and we're working to identify appropriate partners to commercialize to the private markets there. It wouldn't expect until 2023 launch date for that product that'll be out later in '24 beyond, after we establish the right partnership..

Okay, great. Thanks, Ryan..

Thank you. One moment for our next question. Next question comes from the line of Phil Nadeau with TD Cowen. Your line is now open..

Hi, team. It's Ernie Rodriguez for Phil. Congratulations on great quarter. I got a couple of questions from us. On the single protein in the vaccine, what additional data from what has already been disclosed will be presented? If you can elaborate on that.

And what do you think investors should focus on data?.

Hey Ernie. Thanks for the question. We think we've categorized the data pretty well with our initial top-line results. Obviously, there'll be a little bit more insight into the actual numbers in the poster presentation.

I think the key thing to focus on as we said before, which we call which we provided the top-end results to the vaccine response rates, and our overall profile. And this also gives a great opportunity for us to present the data to forum.

So I think that's what's so important about getting this out of just our initial press release and into a poster at a meeting..

Got it. And on the bad debt expense it sounds like there's no much more at risk with Biological E, you have $1 million bond that you expected to collect.

But is there any other uncollected receivables from other customers that you think may be at risk for similar circumstances risk from the dynamics of the market these days?.

Sure, I'll take that one. Thanks so much for the question. And yes, I think your characterization around the remaining exposure as we sit here today for Bio E is limited to only about a million dollars as we've mentioned on the call.

The other -- the only other customer where we have amounts remaining to be collected under the CEPI arrangement is Clover and which you'll see in the 10-Q and quite a bit of additional detail, but just by way of summary we have about $71 million can be collected from Clover.

All of that though, about $60 million has already been received and is backstopped by CEPI. So we expect to collect those amounts, in the next few years as Clover collects on their commercial agreements with China and through other bilateral arrangements..

That is very helpful. Thank you, guys..

Thank you. And 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 the foundation we've built with our continued successful commercialization, execution and positive momentum for HEPLISAV-B, our advancing pipeline and our strong financial position.

I'd like to thank our team at Dynavax for their continued dedication to patients and their families, caregivers and investigators who participate in our study, along with our collaborators and customers for their continued partnership and support. We look forward to updating you on our progress. 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. Everyone, have a wonderful day..