Dynavax Technologies Q1 2023 Earnings Call Transcript

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May 2, 2023

Key Takeaways

  • HEPLISAV-B achieved record Q1 net product revenue of $44 million, a 109% increase year-over-year, and is on track for 30%–50% annual growth in 2023.
  • Market share for HEPLISAV-B rose to 37% overall and about 49% in key retail and IDN segments, driven by strong adoption following the ACIP universal adult hepatitis B recommendation.
  • The U.S. hepatitis B vaccine market grew approximately 45% year-over-year in Q1, with an addressable population second only to flu, and is projected to exceed $800 million by 2027.
  • Dynavax is advancing three CPG1018-adjuvanted vaccine candidates—Tdap (Phase 1 complete; NHP challenge data mid-2023), shingles (Phase 1 complete; Phase III planned in early 2024), and plague (Phase 2 Part 2 enrollment done; topline data in 2024).
  • With $652 million in cash and securities, a Q1 net loss of $24 million, and reaffirmed full-year guidance (HEPLISAV-B revenue $165–185 million; R&D $55–70 million; SG&A $135–155 million), Dynavax expects positive free cash flow and has capacity for strategic M&A.
AI Generated. May Contain Errors.
Earnings Conference Call
Dynavax Technologies Q1 2023
00:00 / 00:00

There are 12 speakers on the call.

Operator

Day, ladies and gentlemen, and welcome to the DynaFacts 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, Investor Relations and Corporate Communications. You may begin.

Speaker 1

Thank you, Norma. Good afternoon and welcome to the Dynavax Q1 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 and 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-ten eighteen adjuvant. These statements involve risks and uncertainties and our actual results may differ materially.

Speaker 1

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 Don Cassell, Chief Commercial Officer Rob Jansen, Chief Medical Officer and Kelly McDonald, Chief Financial Officer. I'll now turn the call over to Ryan. Thank you, Paul,

Speaker 2

and thank you all for joining us today. We're excited to update you on our continued progress in the Q1 as we execute across our core strategic priorities. 1st and foremost, we are focused on driving growth for our commercial product HEPLISAV B, Our adult vaccine for hepatitis B. In the Q1, we were pleased to achieve record quarterly net product revenue once again for FLY70 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.

Speaker 2

We are encouraged by the continued market adoption of HEPLISAV B, Thank you, and good morning, everyone. Thank you, Steve. Good morning, everyone. I'm very pleased to report that we are in the Q1 of 2019. 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%.

Speaker 2

With Q1 revenue increasing 109% compared to Q1 of last year, We are already on track to achieve a 4th year of record revenue for HEPLISAV B. John will review our commercial progress in more detail in a few minutes. We continue to build on the strong executional foundation made in 2022 through further advancement of our pipeline As we progress our 3 adjuvanted vaccine clinical stage candidates for Tdap, shingles and plague And continue to identify new opportunities to leverage CPG1018 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 Episepti opportunity, While making the appropriate investments to advance our clinical stage portfolio.

Speaker 2

In addition, backed by the continued HEPLISAV B growth and our strong cash position, 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 Don to provide more details on the tremendous several times B performance in the Q1.

Speaker 3

Thank you, Ryan. I'm excited to share more details about the very strong performance for HEPLISAV B in the Q1 And our continued progress in capturing market share for the brand. As a reminder, HEPLISAV B is the 1st and only FDA approved Adult hepatitis C 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.

Speaker 3

As Ryan stated, HEPLISAV B's performance in the Q1 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.

Speaker 3

First, the hepatitis C 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 Received hepatitis B vaccination significantly expands the number of adults in the U. S.

Speaker 3

Who are recommended to be vaccinated. Hepatitis B now has the 2nd 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.

Speaker 3

S. Could grow to over $800,000,000 by 2027. During the Q1, we observed hepatitis B vaccine market growth of approximately 45% year over year. This significant market growth was due to a Turn 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 Q1 last year and only 14% in Q1 of 2021.

Speaker 3

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 3rd factor driving growth for HEPLISAV B is strong performance in 2 critical market segments, retail pharmacy And Integrated Delivery Networks or IDS. For the Retail segment, HEPLISAV market share increased to approximately 49% In Q1 compared to approximately 28% at the end of the Q1 of last year. We have made Tremendous progress with the top 10 retail pharmacy chains in the U.

Speaker 3

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 IDNs, at the end of the first quarter, HEPLISAV's market share increased to approximately 49%, compared to approximately 33% at the end of the Q1 last year. Similar to retail, In the IDM segment, we are continuing to see strong conversion from large customers that have adopted the ACFT Universal Recommendation, Driving meaningful increases in their hepatitis B purchases that continue to exceed 2019 pre pandemic levels.

Speaker 3

We believe the retail and IDM segments will see 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 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 ACF universal recommendation uptake.

Speaker 3

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 attributed to the performance of HEPLISAV B exceeding our expectations in the Q1. 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, The continued further growth being driven by the ACIT 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 IDM. 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.

Speaker 3

I will now turn the call over to Rob to take you through our clinical pipeline.

Speaker 4

Thank you, Don. We're focused on advancing an innovative and diversified vaccine pipeline, leveraging Our CPG-ten eighteen adjuvant with proven antigens. Our goal is to build Natal's 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.

Speaker 4

Starting with our tetanus, diphtheria and pertussis or Tdap program. We believe our CPG1018 adjuvant And have 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 trial evaluating an improved Tdap that utilizes our CPG-ten eighteen 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 And support continued advancement of the vaccine candidate. This year, we plan to make important progress with the TDAP program.

Speaker 4

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-twenty 23. We also plan to discuss 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 CPG1018 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 top line results from our Phase 1 clinical trial Designed to evaluate our investigational shingles vaccine utilizing different regimens of CPG-ten eighteen adjuvant.

Speaker 4

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. Now over the course of the year, we expect to complete GMP manufacturing of GE antigen to support initiation of a Phase III study in early 2024. This study will evaluate various dose levels of GE plus CPG1018 adjuvant. Moving on to the PLUG program.

Speaker 4

We're conducting a Phase 2 trial evaluating the immunogenicity, safety and tolerability of a 2 dose RF1b plague vaccine candidate adjuvanted with CPG1018. This is a collaboration with and funded by the U. S. Department of The CPG1018 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 A greater than twofold increase in antibodies over the alum adjuvant and control arm after 2 doses.

Speaker 4

The DoD approved continuing to Part 2 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 CPG1018 to develop new and improved vaccine candidates That provides significant opportunities to address important unmet medical needs. I'll now turn the call over to Kelly to review our financial results.

Speaker 5

Thank you, Rob. I'm pleased to report on another quarter of strong financial execution. I'll review the key financial results from the Q1 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.

Speaker 5

Starting with revenue. Total revenues for the Q1 of 2023 were $47,000,000 driven by HEPLISAV B net product revenue of $44,000,000 Compared to the Q1 of last year, HEPLISAV B net product revenue representing 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 one time charges related to improvement projects at the Germany manufacturing facility in the Q1. Other revenue was $4,000,000 for the Q1, representing revenue related to the PLAY vaccine program in collaboration with and fully funded by the U.

Speaker 5

S. Department of Defense. We continue to be pleased with the progress of this program and the collaboration with the DoD. Turning to CTG1018 adjuvant supply for COVID-nineteen vaccine. As expected, we did not record any COVID-nineteen related revenue this quarter.

Speaker 5

As we have previously indicated, we believe our customers have And related adjuvant sales for Dynavax in 2023. As we progress throughout the year and as we gain clarity around the endemic Demand of COVID-nineteen 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-nineteen CPG-ten eighteen 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 CPG1018 adjuvant supply to CEPI Partners, including Biological E, who has developed and supplied its COVID-nineteen vaccine Corvavax to the Government of India. During the Q1, the credit profile for Biological E was negatively impacted as its cash collections from the Government of India for Correvax has been significantly reduced and delayed.

Speaker 5

Accordingly, in April 2023, we entered into agreements with Biologica Lee and CEPI To resolve the remaining amounts due from Biologica Elite and to fully forgive the corresponding CEPI Advanced payments. This resolution resulted in approximately $12,000,000 in bad debt expense during the Q1, reflecting uncollectible amounts. And we have only $1,000,000 outstanding as of today from BiologicLease, 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 CPG1018 adjuvant for nearly 1,000,000,000 COVID-nineteen vaccine doses across all five of our commercial supply partnerships. Now turning to our research and development expenses for the quarter.

Speaker 5

These increased to $14,000,000 compared to $11,000,000 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 Q1 Increased to $37,000,000 compared to $32,000,000 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.

Speaker 5

We recorded GAAP net loss of $24,000,000 or $0.19 per share basic and diluted in Q1. This is compared to GAAP net income of $33,000,000 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 Q1 with cash, cash equivalents and marketable securities of approximately $652,000,000 An increase compared to our year end balance of $624,000,000 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 and 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 $165,000,000 to $185,000,000 Research and development expenses of between $55,000,000 to $70,000,000 and selling, general and administrative expenses to be between $135,000,000 to $155,000,000 In closing, we continue to execute on our core priorities across We are focused on strong operational and financial performance as well as being extremely thoughtful in how we allocate our capital 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.

Speaker 5

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 and A portion of today's call.

Operator

Thank you. One moment for our first question. Our first question comes from the line of Matthew Phipps with William Blair. Your line is now open.

Speaker 6

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 of the CDC, and I wondered if any of that might apply to you all. And then Don, I'd like to focus on the retail and the IDN and seeing that grow as a way to grow the brand. If you get 50 The market share and continue to grow market share in those brands, does that spill over into some

Speaker 7

of the rest of the markets?

Speaker 2

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

Speaker 3

So, Matt, regarding Your first question on CDC purchasing, that really wasn't something that impacted our revenue from a HEPLISAVI perspective. We 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 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 And these other segments as well.

Speaker 6

Great. Thanks, Don. 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 Size of markets for those things.

Speaker 2

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 That's from a business platform perspective. I mean, going beyond prophylactic interventions, we still feel that we can leverage our Corporate capability within infectious disease, so the focus is on high synergies accretive deals for commercial products.

Speaker 1

Great. Thanks for taking my questions.

Operator

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

Speaker 8

Great. Thanks for taking the Questions and congrats on the strong quarter. I guess given how strong it was and ahead of expectations, what are the

Speaker 2

Thanks, Josh. What really This

Speaker 8

is the Q1.

Speaker 2

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, I thought it's just too early in the year. We'd like to have another quarter or so to be able to really identify the market trends around growth before we Change any guidance.

Speaker 8

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?

Speaker 2

Yes, we know there's Traditional seasonality, but Don, you want to comment on how the ACIP growth could play into the typical seasonality that we see?

Speaker 3

Yes. 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 RSV vaccine, certainly in the retail segment. But that being said, RSV is going to be for 65 plus and when we think about retail and HEPLISAVY 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 see in the past, Particularly in Q4. As it relates to ACIP, I don't know if that's going to impact seasonality per se.

Speaker 3

I think ACIP is going And

Speaker 1

then last question The other

Speaker 8

asset line increased by about $70,000,000 in the quarter. What drove that?

Speaker 5

Sure, Duffy, I can take that. So that's simply a reclassification of amounts associated with The clover and CEPI arrangement from current to non current.

Speaker 8

Thanks very much.

Operator

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

Speaker 9

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 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.

Speaker 2

Thanks, Rob. I think ultimately market growth is critically important. I mean we've already reported that we're at 37% now on market We will continue to advance that stated majority share. But as you noted by some of our prior kind of disclosure of the market size being drawn from $400,000,000 to 800,000,000 By 2027, that 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 at the point now where we would sort of project slowing of market share growth.

Speaker 2

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 is going to be critical.

Speaker 9

Thanks.

Operator

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

Speaker 10

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 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.

Speaker 10

Why would HEPLISAV maybe not expand the dialysis opportunity? Thanks.

Speaker 2

Sure. Just To be clear, we really are favorable on our profile in dialysis with the adjuvanted vaccine. So we're excited to be able to Give the SPLA and so we can begin to actively promote that segment, 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 As HEPLISAV moves into that space, we think it will do very well, but it doesn't grow the market size because The amount of doses used in that space compared to the amount of doses used with Hemmel's leverage.

Speaker 10

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 CPG1018 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 onetwo? Thanks.

Speaker 2

Rob, you want to take that?

Speaker 4

Sure. So we haven't made final decisions on either CBG1018 dose. We do anticipate doing a dose escalation of at least 3 or 4 levels of But again, the final decisions on those aspects of the study design haven't been made yet.

Operator

Okay, great. Thank you.

Speaker 2

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

Speaker 10

Okay, perfect.

Operator

Thank you. One moment for our next question. Question comes from the line of Ed White with H. C. Wainwright.

Operator

Your line is now open.

Speaker 7

Good afternoon. Thanks for taking my questions. With the market share growth we saw in retail this quarter, Were there any new retail initiatives in the Q1 of this year? And do you have any plans for the rest of 2023? And then I also wanted to get your thoughts on potential DTC advertising to drive retail sales.

Speaker 2

Don, you want to handle this?

Speaker 3

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 Q2 to get out ahead of the flu season. As I mentioned during my comments, we have various initiatives with

Speaker 2

3 of

Speaker 3

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 tie into 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 and HEPLISAV B.

Speaker 3

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

Speaker 2

Thanks for the question. And I mean, and just to put a final point on it, DTC is It's going to be very large. We have a very focused approach to DTC that we think can be very effective.

Speaker 7

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

Speaker 2

and beyond that. Yes. I mean, we're we did receive the authorization and we're working to identify appropriate partners to commercialize to the Private markets there. I wouldn't expect us to 2023 launch date for that product that will be out later in 'twenty four beyond after we establish the right partnership.

Speaker 7

Okay, great. Thanks, Ryan.

Operator

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

Speaker 11

Hi, Tim. It's Ernie Rodriguez for Phil. Congratulations on a great quarter. I got a couple of questions from us. On the shingles presentation on the vaccine, What additional data from what has already been disclosed will be presented then if you can elaborate on that?

Speaker 11

And What do you think investors should focus on data?

Speaker 2

Ernie, thank you for the question. We think we 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 things to focus on as we've said before, which we provided the top line results of the vaccine response rates And our overall profile

Speaker 6

and this is also a

Speaker 2

great opportunity for us to present the data in peer reviewed forums. So I think that's what's so important about getting this out of just our initial press release into a poster at a meeting.

Speaker 11

Got it. And on the bad debt expense, it sounds like There is not much more at risk with biological e. You have $1,000,000 born that you expect to collect. But is there any other Collected receivables from other customers that you think may be at risk for similar Circumstances, risks from the dynamics of the market these days?

Speaker 5

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 BioE is limited to only about $1,000,000 as we mentioned on the call. The other the only other customer where we have amounts remaining to be collected under the CEPI arrangement It's Clover and just as 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 $71,000,000 to be collected from Clover. Of that though, about $60,000,000 has already been received and is backstopped by CEPI.

Speaker 5

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.

Speaker 11

Got it. Very helpful. Thank you, guys.

Operator

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.

Speaker 2

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 epilepsy, Our advancing pipeline and our strong financial position. I'd like to thank our team at Dynavax for their continued dedication, the patients and their families, caregivers 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

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