Q1 2023 Dynavax Technologies Corp Earnings Call

Participants

Donn Casale; Chief Commercial Officer; Dynavax Technologies Corporation

Kelly MacDonald; Senior VP & CFO; Dynavax Technologies Corporation

Paul Cox; VP of IR & Corporate Communications; Dynavax Technologies Corporation

Robert Janssen; Chief Medical Officer and Senior VP of Clinical Development, Medical & Regulatory Affairs; Dynavax Technologies Corporation

Ryan Spencer; CEO & Director; Dynavax Technologies Corporation

Douglas Royal Buchanan; Director & Equity Research Analyst; JMP Securities LLC, Research Division

Edward Patrick White; MD of Equity Research & Senior Healthcare Analyst; H.C. Wainwright & Co, LLC, Research Division

Ernesto Luis Rodriguez-Dumont; Associate; TD Cowen, Research Division

Joshua Elliott Schimmer; Senior MD & Equity Analyst; Evercore ISI Institutional Equities, Research Division

Matthew Christopher Phipps; Senior Biotechnology Research Analyst; William Blair & Company L.L.C., Research Division

Robert Luis Palermo; Research Analyst; Goldman Sachs Group, Inc., Research Division

Presentation

Operator

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

Paul Cox

Thank you, Norma. Good afternoon, and welcome to the Dynavax 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 impact on each financial guidance and trends, including revenue, profitability and sufficiency of current capitalization, timing and results of 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. 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.

Ryan Spencer

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 are focused on driving growth for our commercial product, HEPLISAV-B, our adult vaccine for Hepatitis B. In the first quarter, we were pleased to achieve record quarterly net product revenue once again through 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 driven 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%. The 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 will review our commercial progress in more detail in a few minutes. We continue to build on the strong executional foundation late in 2022 through further advancement of our pipeline as we progress our three adjuvanted 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 collaboration. Rob will walk through our expected progress for our 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 include 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.

Donn Casale

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 2 doses in 1 month. Series completion is essential for high levels of protection. In an era of universal Hepatitis B recommendation, 2 dose HEPLISAV-B can make series completion easier and protect more patients faster than a 3-dose regimen. As Ryan stated, HEPLISAV-B's performance in the first quarter exceeded our expectations.
In the quarter, net product revenue for HEPLISAV-B grew 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 adult age 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 a 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 in 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 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 28% 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 3 of the top 4 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 continuing to see strong conversion from large customers that 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 most of the anticipated market growth from the ACIP universal recommendation.
Both segments have 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 approximately 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 from 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.
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.

Robert Janssen

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 an adult vaccine portfolio of best-in-class products. We're currently advancing clinical programs for 3 adjuvanted 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 I clinical trial, 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. Now 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 and CD4-positive T cells, which are key in controlling reactivation of the zoster virus and preventing shingles.
In January, we reported topline results from our Phase I clinical trial designed to evaluate our investigational shingles vaccine utilizing different regimens of CpG 1018 adjuvant. The Phase I 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. Now over the course of the year, we expect to complete GMP manufacturing of GE antigen to support initiation of a Phase I/II 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 II trial evaluating the immunogenicity, safety and tolerability of a 2-dose rF1V-plague vaccine candidate adjuvanted with CpG 1018. This is a collaboration with and funded by the U.S. Department of Defense or DoD. 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 3-dose vaccine under development by the DoD. In January, we successfully completed Part 1 of the clinical trial. Both CpG 1018 adjuvanted arms met the Part 1 primary endpoint by demonstrating a greater than twofold increase in antibodies over the alum adjuvanted control arm after 2 doses.
The DoD approved continuing to Part 2 of the Phase II program, and we're pleased to announce today that we recently completed enrollment in Part 2. Topline 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.

Kelly MacDonald

Thank you, Rob. I'm pleased to report on another quarter of strong financial execution. I'll review the key financial results from the first quarter and then review our full year 2023 guidance and provide a few closing thoughts. 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 first quarter of 2023 were $47 million, driven by HEPLISAV-B net product revenue of $44 million. Compared to the first quarter of last year, HEPLISAV-B net product revenue represented an increase of 109%. We are excited about the continued growth of the brand, which is tracking to the higher end of our revenue expectations for the full year.
We are also pleased with the continued trend in the margin profile for HEPLISAV-B with gross margins expected to exceed 70% for the year despite certain onetime charges related to improvement projects at the Germany manufacturing facility in the first quarter. Other revenue was $4 million for the first quarter, representing revenue related to the plague vaccine program in collaboration with and fully funded by the U.S. Department of Defense. We continue to be pleased with the progress of this program and the collaboration with the DoD.
Turning to CpG 1018 adjuvant supply for COVID-19 vaccine; as expected, we did not record any COVID-19-related revenue this quarter. As we have previously indicated, we believe our customers have sufficient adjuvant stockpile to fulfill their near-term demand, translating to minimal to as little as zero COVID-19-related adjuvant sales for Dynavax in 2023. As we progress throughout the year and as we gain clarity around the endemic demand of COVID-19 vaccines for our customers, we will provide updates around any potential future commercial supply agreements for 2024 and beyond.
We continue to collect on amounts outstanding from our COVID-19 CpG 1018 adjuvant supply customers. As a reminder, early in the pandemic, CEPI provided funding to Dynavax in the form of a fully forgivable loan to support CpG 1018 adjuvant supply to CEPI partners, including Biological E., who has developed and supplied its COVID-19 vaccine CORBEVAX to the Government of India. During the first quarter, the credit profile for Biological E. was negatively impacted as its cash collections from the Government of India for CORBEVAX has been significantly reduced and delayed.
Accordingly, in April 2023, we entered into agreements with Biological E. and CEPI to resolve the remaining amounts due from biologically and to fully forgive the corresponding CEPI advanced payments. This resolution resulted in approximately $12 million in bad debt expense during the first quarter, reflecting uncollectible amounts. And we used only $1 million outstanding as of today from Biological E., which we expect to collect later this year. Overall, we continue to be very proud of the way we've navigated such a complex and dynamic environment and our meaningful role in the global response to the pandemic, delivering CpG 1018 adjuvant for nearly 1 billion COVID-19 vaccine doses across all five of our commercial supply partnerships.
Now turning to our research and development expenses for the quarter; these increased to $14 million compared to $11 million in the prior period. This increase was driven by continued advancement in our clinical pipeline programs, as Rob mentioned. Selling, general and administrative expenses for the first quarter increased to $37 million compared to $32 million in the prior period. The increase was primarily driven by higher personnel-related costs and an overall increase in targeted marketing efforts to drive HEPLISAV-B market share and drive market expansion in key segments that we believe will disproportionately benefit HEPLISAV-B.
Now turning to net loss; we recorded GAAP net loss of $24 million or $0.19 per share basic and diluted in Q1. This is compared to GAAP net income of $33 million or $0.26 per share basic and $0.22 per share diluted for the prior year period. Turning to the balance sheet; we ended the first quarter with cash, cash equivalents and marketable securities of approximately $652 million, an increase compared to our year-end balance of $624 million. Based on our current operating plans, we expect to finish 2023 with positive free cash flow for the year. We continue to believe that this level of capital is sufficient to support our core business, enabling us to drive sustainable growth in HEPLISAV-B to capture a majority market share and bring our R&D portfolio of vaccine candidates forward without needing to return to the capital markets.
We are also pleased to reaffirm our full year 2023 financial guidance, which includes the following expectations: 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.

Question and Answer Session

Operator

(Operator Instructions) Our first question comes from the line of Matthew Phipps with William Blair.

Matthew Christopher Phipps

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 have applied to you all? And then Donn, I'd like to focus on the retail and the IDN and seeing that grow as a way to grow the brand. If you got 20% market share and continue to grow market share in those brands, would that spill over into some of the rest of the markets?

Ryan Spencer

Sure, Matt. Okay. No, go ahead, Donn, go ahead and take it away.

Donn Casale

So Matt, regarding your first question on CDC purchasing, that really wasn't something that impacted our revenue from a HEPLISAV-B perspective, we sell 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 resources. 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.

Matthew Christopher Phipps

Great. 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 you can give around the size of the market for those things.

Donn Casale

Thanks, Matt. No, not necessarily prophylactic. 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 going beyond peak prophylactic interventions, we still feel that we can leverage our corporate capability within infectious disease. So the focus is on high synergies accretive deals that for commercial products.

Operator

Our next question comes from the line of Josh Schimmer with Evercore ISI.

Joshua Elliott Schimmer

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

Ryan Spencer

Josh, 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 relate to the final market trends around growth before we change any guidance.

Joshua Elliott Schimmer

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.

Ryan Spencer

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?

Donn Casale

Yeah, Josh, to Ryan's point, we're going to see the seasonality we've seen in years past and in 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 rF1V vaccine certainly in the retail segment. But that being said, rF1V's 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 have seen in the past, particularly in Q4. 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 said before, both in retail and in IDN.

Joshua Elliott Schimmer

Got it. And then last question for me (inaudible) asset line increased by about $70 million in the quarter. What drove that?

Kelly MacDonald

Sure, Joshua, I can take that. So that's simply a reclassification of amounts associated with the Clover and CEPI arrangement from current to noncurrent.

Operator

And our next question comes from the line of Madhu Kumar with Goldman Sachs.

Robert Luis Palermo

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?

Ryan Spencer

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

Operator

Our next question comes from the line of Roy Buchanan with JMP Securities.

Douglas Royal Buchanan

Great quarter. First one is on dialysis. And just can you review your views on the opportunity in that segment? Any reason to not expect a 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 maybe not expand the dialysis opportunity?

Ryan Spencer

Sure. Just to be clear, we'd really -- are favorable on our profile dialysis with the adjuvanted vaccine. So we're excited to be able to give the sBLA and so we can begin to actively promote that segment. And we would expect to do pretty well there. The reality is that market doesn't grow because right now, it's solved with basically 8 doses of the traditional vaccine. And the patient population isn't expected to grow there like it is in other segments. And so HEPLISAV moves into that space, we think it will do very well, but it doesn't grow the market size because of the amount of doses used in that space compared to with the (inaudible) with HEPLISAV.

Douglas Royal Buchanan

Okay, great. And then a few on the shingles; I'm not sure if you can tell us, but if you can, the 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 planned size of the Phase I/II?

Ryan Spencer

Sure. Rob, do you want to take that?

Robert Janssen

Sure. So we haven't made final decisions on either CpG 1018 dose. We do anticipate doing a dose escalation of at least 3 or 4 levels of GE. But again, the final decisions on those aspects of the study design haven't been made yet.

Ryan Spencer

And we'll be also working with the FDA this year to clarify the regulatory path forward and finalize eventual trial designs.

Operator

Our next question comes from the line of Ed White with H.C. H.C. Wainwright.

Edward Patrick White

With the market share growth we saw in 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 then I also wanted to get your thoughts on potential DTC advertising to drive retail sales.

Ryan Spencer

Donn, do you want to handle those?

Donn Casale

Sure. Ed, yes, 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 initiatives in the second quarter to get out ahead of the flu season. As I mentioned during my comments, we have various initiatives with 3 of the top 4 retail chains throughout the country. That gives 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 tied 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 and their infrastructure to get to their patients and their consumers throughout the year.

Ryan Spencer

And the question in, and I mean -- and just to put a fine point on it, DTC is -- it's going to be very large. We have a very focused approach to DTC that we think will be very effective.

Edward Patrick White

Okay. 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 and beyond that?

Ryan Spencer

Yeah. I mean we're -- we did just receive the authorization and we're working to identify appropriate partners to commercialize to the private markets there. Wouldn't expect that the 2023 launch date for that product -- that will be out later into '24 and beyond after we establish the right partnership.

Operator

Our next question comes from the line of Phil Nadeau with TD Cowen.

Ernesto Luis Rodriguez-Dumont

Rodriguez for Phil. Congratulation on a great quarter. I've got a couple of questions from us. On the shingles (inaudible) vaccine, what additional data from what has already been disclosed will be presented then if you can elaborate on that? And what do you think investors should focus on data?

Ryan Spencer

Ernie, thank you for the question. We think we've categorized the data pretty well with our initial top line results. But obviously, there will be a little bit more insight into the actual numbers in the poster presentation. And I think the key thing to focus on is we (inaudible) we provided the top line results of the vaccine response rates and our overall profile. And this also gives a great opportunity for us to present the data at (inaudible) forum. So I think that's what's so important about getting this out of just our initial press release to a poster at a meeting.

Ernesto Luis Rodriguez-Dumont

Got it. And on the bad debt expense, sounds like there's not much more at risk with Biological E. You have around $1 million more than you expect to collect. But is there any other uncollected receivables from other customers that you think may be at risk for similar circumstances risk on the dynamics of the market these days.

Kelly MacDonald

So I'll take that one, Ernie, 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 $1 million, as we 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 what you'll see in the 10-Q in quite a bit of additional detail. But just by way of summary, we have about $71 million to be collected from Clover. Of that, though, about $60 million has already been received and is backed up 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.

Operator

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.

Ryan Spencer

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 studies, 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.

Operator

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