Q1 2023 Dynavax Technologies Corporation Earnings Call
Speaker 2: 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.
Speaker 2: I would now like to turn the call over to Paul Cox, Vice President Investor Relations and Corporate Communications. You may begin.
Speaker 3: Thank you, Norma. Good afternoon and welcome to the DynaVax first quarter 2023 Financial Results and Corporate Update conference call.
Speaker 3: In addition to our press release issue today, a supplementary slide presentation that accompanies today's call is available in the events section of our website.
Speaker 3: 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.
Speaker 3: and related ACIP recommendation impact on each financial guidance and trends, including revenue, profitability, and sufficiency of current capitalization.
Speaker 3: timing and results of clinical trial starts and data readouts, and potential future uses of or demand for our CPG-1018 adjuvant.
Speaker 3: These statements involve risks and uncertainties, and our actual results may differ materially.
Speaker 3: These risks are summarized in today's press release and detailed in the Risk Factor section of our FCC filings, including today's quarterly report on Form 10Q.
Speaker 3: Our forward-looking statements speak as of today, and we undertake no obligation to update such statements.
Speaker 3: Joining me on the call today are Ryan Spencer, Chief Executive Officer, Don Cassell, Chief Commercial Officer. Ryan Spencer, Chief Executive Officer, Don Cassell, Chief Commercial Officer, Don Cassell,
Speaker 3: Rob Jansen, Chief Medical Officer, and Kelly McDowell, Chief Financial Officer.
Speaker 3: I'll now turn the call over to Ryan.
Speaker 3: 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.
Speaker 3: First and foremost, we are focused on driving growth for our commercial products, Heplisat-B, our adult vaccine for hepatitis B.
Speaker 3: In the first quarter, we were pleased to achieve record quarterly net product revenue once again for EPLOS-WV 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.
Speaker 4: The tremendous results this quarter even exceeded our own expectations.
Speaker 4: We are encouraged by the continued market adoption of HEPLIS-FV, driven in part by the expanded ACIP recommendation for adult hepatitis D vaccination, and look forward to demonstrating continued revenue and market share growth this year.
Speaker 4: Last year, Hebla Sébi revenue doubled compared to 2021, and we anticipate continued annual revenue growth for Hebla Sébi in 2023, in the range of 30 to nearly 50 percent.
Speaker 4: With Q1 revenue increasing 109% compared to Q1 of last year, we are already on track to achieve a fourth year of record revenue for EPIS-FB. Dawn will review our commercial progress in more detail in a few minutes.
Speaker 4: We continue to build on the strong executional foundation made in 2022 to further advancement of our pipeline. As we progress our 3, as you did that same clinical stage candidates for. Shingles and plague and continue to identify new opportunities to leverage CPG 1018 in our preclinical efforts.
Speaker 4: both internally and through our collaboration.
Speaker 4: Rob will walk through our expected progress for our clinical programs this year in detail later on in the call.
Speaker 4: Based on our strong execution, we are in a financial position that enables us to support our efforts to maximize the efforts of the opportunity.
Speaker 4: while making the appropriate investments with the Antro-Clinical Stage Portfolio.
Speaker 4: 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.
Speaker 4: Our initial prioritization of external opportunities includes the following two categories.
Speaker 4: Commercial or late stage assets in the vaccine space to leverage our expertise in the field and our fully integrated capability.
Speaker 4: and highest energy 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.
Speaker 4: I'll now turn the call over to Dawn to provide more details on the tremendous Heplis
Speaker 5: Thank you, Ryan.
Speaker 5: I'm excited to share more details about the very strong performance for Hepatitis B in the first quarter and our continued progress in capturing market share for the brand. As a reminder, Hepatitis B is the first and only FDA-approved adult Hepatitis B vaccine that allows serious completion with only two doses in one month.
Speaker 5: Series completion is essential for high levels of protection.
Speaker 5: In a narrow of universal hepatitis B recommendation, two dose Heplis FD can make series completion easier and protect more patients faster than a three dose regimen.
Speaker 5: As Ryan stated, HEPASABD's performance in the first quarter exceeded our expectations.
Speaker 5: In the quarter, net product revenue for HEPLO FABB grew 109% year-over-year.
Speaker 5: This significant revenue growth in the U.S. was driven by several factors.
Speaker 6: First,
Speaker 5: The hepatitis B market continues to grow in the US following the ACFD universal recommendation for hepatitis B vaccination.
Speaker 5: The AISIP'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.
Speaker 5: Hepatitis B now has the second highest addressable adult population for vaccination in the US.
Speaker 5: more than shingles and pneumococcal vaccination, and a second only to flu.
Speaker 5: This represents a large and growing market opportunity.
Speaker 5: We continue to believe this recommendation will be a significant catalyst for growth and estimate the Hepatetasty Market Opportunity in the US could grow to over $800 million by 2027.
Speaker 5: During the first quarter, we observed hepatitis B vaccine marking growth of approximately 45% year-over-year.
Speaker 5: This significant market growth was due to a return to routine healthcare operations plus market expansion as a result of the ACFD universal recommendation.
Speaker 5: The second factor underlying Heplis-Evbe's performance is the continued positive trend toward securing a majority market share within the expanding Heplis-Evbe market.
Speaker 5: We continue to demonstrate gains in market share quarter over quarter and estimate that hepless at these 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
Speaker 5: the Quancho Market Share Growth from 2-4 of last year, where Heppless and V had a 35% share. The Quancho Market Share Growth from 2-4 of last year, where Heppless and V had a 35% share.
Speaker 5: We continue to be very encouraged by this positive trend towards capturing a majority market share by 2027.
Speaker 5: The third factory driving growth for Hempelstead B is strong performance in two critical market segments.
Speaker 5: Retail Pharmacy and Integrated Delivery Networks or IDN.
Speaker 5: For the retail segment, Hevelset B's market share increased to approximately 49% in Q1 compared to approximately 20% at the end of the first quarter of last year.
Speaker 5: We have made tremendous progress with the top 10 retail pharmacy chains in the US.
Speaker 5: characterized by increases in initial purchases and reordering at higher volume.
Speaker 5: With several large national chains making headless at B, the preferred adult hepatitis B vaccine.
Speaker 5: Additionally, during the quarter, we initiated collaborative marketing initiatives with three of the top four National Retail Chain.
Speaker 5: demonstrating the continued excitement around Heppl-Sav-B and the ASTAP universal opportunity.
Speaker 5: For IDN, at the end of the first quarter, Hetland-Febbe's market share increased to approximately 49% compared to approximately 33% at the end of the first quarter last year.
Speaker 5: Similar to retail in the IDN segment, we are continuing to see strong conversions from large customers that have adopted the ATP 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...
Speaker 5: If you're most of the anticipated marketing growth from the ACIP Universal Recommendation.
Speaker 5: Both segments have the required institutional control, infrastructure, capabilities, and patient volume that can drive universal uptake.
Speaker 5: 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 hepatitis B now making up approximately 50% of the market share across these two segments.
Speaker 5: We have established long-term relationships with key vaccine decision makers, along with a deep understanding of the bind process and operational levers that can help us drive ACFU universal recommendation updates.
Speaker 5: 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 segment. In summary, we are very encouraged by our continued progress and momentum in the key segments of retail and IDN.
Speaker 5: both of which significantly contribute to the performance of Hepplishebbi exceeding our expectations in the first quarter. In 2023, we forecast the Hepplishebbi market opportunity will grow 15 to 25% from 2022 levels and exceed 2019 utilization.
Speaker 5: showing not only a complete rebound from pandemic-related disruptions of the market, but continued further growth being driven by the ACIT Universal Recommendation.
Speaker 5: In addition to total market growth, we expect HEPLIS MB will continue to increase its market share across all segments.
Speaker 5: 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 Heppless Ave. And not only anlocals but many do deal in it. And not only anlocals but many do deal in it.
Speaker 5: I will now turn the call over to Rob to take you through our clinical pipeline.
Speaker 7: Thank you, Don. We're focused on advancing an innovative and diversified vaccine pipeline leveraging our CPG-1018 adjuvant with proven antigens.
Speaker 7: Our goal is to build Mattel's vaccine portfolio of best-in-class products.
Speaker 7: We're currently advancing clinical programs for three edge-vended vaccines, T-DAP, Shingles, and Plague.
Speaker 7: We're also exploring multiple innovative pre-clinical and discovery efforts with leading collaborators.
Speaker 7: Starting with our Tetanus Diphtheria and Pertussis Sport TDAP program, we believe our CPG-1018 Agenda has the potential to improve the durability of protection against Pertussis by redirecting T cells and enhancing protective antibody responses in a booster vaccine.
Speaker 7: Last year we completed a Phase I clinical trial evaluating an improved T-Deb vaccine that utilizes RCPG-1018 Agibit.
Speaker 7: Adults and adolescent safety data from this study demonstrated the vaccine candidate was well tolerated without insert safety concerns.
Speaker 7: Adult immunogenicity results were consistent with our expectations and support continued advancement of the vaccine candidate.
Speaker 7: This year, we plan to make important progress with the TDAP program.
Speaker 7: 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.
Speaker 7: 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 Plan Human Challenge Study following that interaction.
Speaker 7: And we also continue to advance our Shingles vaccine program.
Speaker 7: 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 top-line results from our Phase 1 clinical-
Speaker 7: the regulatory path forward with the FDA this year.
Speaker 7: Now over the course of the year, we expect to complete GMP manufacturing of GE, the Energy Energy to support initiation of a Phase I II study in early 2024.
Speaker 7: This study will evaluate various dose levels of GE plus CPG-1018 atriumant.
Speaker 7: Moving on to the PLAGE program.
Speaker 7: We're conducting a Phase II trial evaluating the immunogenicity safety and tolerability of a two-dose RF1D PLEG vaccine candidate, adjuvended with CPG-1018. This is a collaboration with and funded by the U.S. Department of Defense or DOD. The CPG-1018 adjuvended vaccine candidates mechanism of action.
Speaker 7: Has the potential to speed up time to protection with fewer doses compared to the three dose vaccine under development by the DOD?
Speaker 7: In January , we successfully completed Part 1 of the clinical trial. Both CPG-1018 adjuvenate arms met the Part 1 primary endpoint by demonstrating a greater than two-fold increase in antibodies over the alum adjuvenate control arm after two doses.
Speaker 7: The DOD approved continuing to part two of the Phase II program and we're pleased to announce today that we recently completed enrollment in part two. Topline data are anticipated in 2024.
Speaker 7: 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.
Speaker 8: 23 guidance and provide a few clothing thoughts.
Speaker 8: Please note that all financial comparisons are versus the prior year period and must otherwise notice. Please also refer to our press release and form 10Q for detailed financial information.
Speaker 8: Starting with revenue, total revenues for the first quarter of 2023 or $47 million. Driven by Heppleston B. Nets product revenue of $44 million. Compared to the first quarter of last year, Heppleston B. Nets product revenue represented an increase of 109%. We are excited about the continued growth of the brand.
which is cracking 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 Hepplis FB, 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 first quarter.
Other revenue was $4 million for the first quarter, representing revenue related to the Play vaccine program in collaboration with and fully funded by the U.S. Department of Defense. We continue to be placed with the progress of this program and the collaboration with the DOD.
Turning the 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 customer theft sufficient adjuvant stockpile to fulfill their near-term demand, translating to minimal to as little as zero.
COVID-19 related Agenda 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 that amount outstanding from our COVID-19, CPG-18 Aged and Supply Customers. As a reminder, early in the pandemic, CEPI provided funding to Dynavac in the form of a fully forgivable loan to support CPG-18 Aged and Supply to CEPI partners.
including biological E who has developed and supplied its COVID-19 vaccine corbohax to the government of India. During the first quarter, the credit profile for biological E was negatively impacted as its cash collection from the government of India for corbohax has been significantly reduced and delayed.
Accordingly, in April 2023, we entered into agreements with biologically and Steppe to resolve the remaining amounts due from biologically and to fully forgive the corresponding Steppe advance payments.
This resolution resulted in approximately $12 million in bad debt expense during the first quarter, reflecting uncollectable amounts.
And we have only $1 million outstanding as of today from biologically, 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 in our meaningful role in the global response to the pandemic, delivering CPG-1018 Agenda 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 Hepplis-Ed B. market share and drive market extension and key segments that we believe will disproportionately benefit Hepplis-Ed B.
Now turning to net loss, we recorded gap net loss of $24 million, or $0.19 per share basic and diluted in Q1. This is compared to gap 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 equivalent, and marketable securities of approximately $652 million dollars, and increased compared to our year end balance of $624 million dollars.
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 and health and health as we get to capture a majority market share and bring our R&D portfolio of vaccine candidates forward without needing to return to the capital market.
We are also pleased to reaffirm our full year 2023 financial bed, which includes the following expectations.
Double-SABB net product revenue to be between $165 to $185 million. Research and development expenses of between $55 to $70 million and selling general and administrative expenses to be between $135 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 today 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 a Q&A portion of today's call.
Thank you. As a reminder to ask a question, you'll need to press star 11 on your telephone. Would draw your question, please press star 11 again. Please wait for your name to be announced. Please stand by. We'll recompile the Q&A roster.
One moment for our first question. Our first question comes from the line of Matthew Sips with William Blair. Your line is now open. The first question comes from the line of Matthew Sips with William Blair.
Good afternoon. Thanks for my questions and congrats on continued great launch growth of HealthTap. 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.
So when I'm done, I'd like to focus on the retail and the IDN and seeing that grow as a way to grow the brand. If you have 50% market share and continue to grow market share in those brands, does that spill over into some of the rest of the markets?
Sure, Matt. Okay.
No, go ahead, don't go ahead and take away. So Matt regarding your first question on CDC purchasing, that really wasn't something that impacted our revenue from a Hepplishebby perspective. We saw typical CDC purchasing in the public sector. Sure.
So that wasn't really nothing that was of note for Q1 for EPLSAPB. Regarding kind of that still over 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. 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 you know, the size of the market's little thing for God we were there putting us all back up.
Thanks, Pat. No, not necessarily prophylaxis. The point is recognizing that we want to broaden the aperture a little bit, have access to valuable transactions that can leverage our capabilities from a business platform perspective I mean. Thank you.
We're going beyond the prophylaxic interventions. We still feel that we can leverage our corporate capability within infectious disease. So the focus is on highest energy to create a deal.
We can feel, we can leverage our corporate capability within infectious disease. So, you know, the focus is on highest energy to create a deal that is for commercial products.
Good, thanks for taking my questions.
Thank you. One moment for our next question. Thank you.
The next question comes from the line of Josh Schimmer with Evercore ISI. The line is now open.
Great. Thanks for taking the questions and congrats on the strong quarter. I guess given how strong it was in the head of expectations, what are the uncertainties that have kept you from raising your guidance for the year?
Thanks, Josh. What really is the first quarter? We did see a really good growth in the market. We recognized we're sort of tracking out to Q1 to the midpoint. You 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.
related to the fight market trends around growth before we change the guidance. Got it. And what kind of seasonality are you expecting of 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 don't you want to comment on how the ECFE groups 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 in particular Q4.
I've 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 465 plus. And when we think about retail and hephalphabieta and hepatitis B vaccination, there's a tremendous focus on 30 to 50, your old patients.
So what the container monitor that but we'll see you'll certainly That typical seasonality that we would see in the past particularly in the 1024 As it relates to ACIP I don't know that's gonna
Impact season alley per se I think ACIP is going to continue to be a catalyst for continued growth as we said before both in retail had an idea. Then last question from the other asset line increased by about 70 million in the quarter. What drew that?
I can take that. So that's simply a reclassification of amounts associated with the clover and sepia arrangement from current to noncurrent.
Thanks very much.
Thank you. One moment for our next question.
And our next question comes from the line of Madhub Kumar with Goldman Sachs. Your line is now open.
Hey, thanks for taking our questions. This is Rob on from mydo.
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.
as being 480, 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 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.
The question comes from the line of Roy Buchanan with JMP Securities. Your line is now open.
Thanks for taking the questions. Great quarter. First one's 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 six, I mean, it looks like the total dollar amount doesn't really grow. The percent, you know, goes down by about half the market size goes up by about half. Why would...
You know, HEPLIS-7 may be not expand the dialysis opportunity. Thanks.
Sure, just to be clear, we really are favorable on our profile analysis with the adjuvants of vaccine. So we're excited to be able to give the SBA and so we can begin to actually move into 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 a basically e-doses of the traditional vaccine. And the patient population is expected to grow there like it is in other segments. So as he has had to move into that space, we think it'll do very well, but it doesn't grow the market side. Because...
of the amount of doses used in that space compared to with the amount of doses used with the Hubble coverage. Okay, great. Then a few on the shingles. 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 plan size of the Phase 1, 2, thanks.
Robin, you want to take that? Sure. So, we haven't made final decisions on either CBG-1018 dose. We do anticipate doing a dose escalation of at least three or four levels of GE, but again, final decisions on those aspects of the study design haven't been made yet. Thank you.
Okay, great. Thank you. And we'll be also working with the FDA this year to clarify the regulatory path forward and finalize eventual trial designs.
Okay, perfect. Thank you. One moment for our next question. Shun comes from the line of Ed White with HC Wainwright. Your line is now open. Good afternoon. Thanks for taking my questions.
With the market shared growth, we saw in retail this quarter where there are any new retail initiatives in the first quarter of this year and 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.
Ed, do you want to handle this? 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 CSS.
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 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 HepplSavB. So that's our strategy to leverage retail and their infrastructure to get to their patients and their consumers throughout the year.
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 can be very effective.
Okay, thanks. And just a question on Europe . So you received marketing authorization in Great Britain in April . They just wanted to get your thoughts on the opportunity in Europe for perhaps just 2023 or in beyond that.
Yeah, I mean, we did receive the authorization and we're working to identify appropriate partners to commercialize to the private market there. We didn't expect that to 2023 launch date for that product. That will be out later in the 24 beyond after we established our right partnership.
Okay, great. Thanks, Ryan. Thank you.
Our next question comes from the line of Phil Nadeau with TD Cowen. Your line is now open. Hi, Tim. This is Ernie Rodriguez for Phil. Congratulations on a great order. I got a couple of questions from us. On the Tingles presentation on the 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? Hey, Ernie. Thank you for the question.
You know, we think we categorize 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. I mean, to see, keeping the focus on as we took for which we've accomplished we provided the top-line results to the vaccine response rates and our overall profile. And this also gives a great opportunity for us to present the data to you.
You expect to collect, but is there any other collected receivables from other customers that you may be at risk for similar circumstances risk from the dynamics of the market this day?
amounts remaining to be collected under the CEPI arrangement is clover. And what you'll see in the 10Q 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 dollars has already been received in its backstop by CEPI. So we expected collect those amounts, you know, in the next few years as clover collects on their commercial agreements with China and through other bilateral arrangements.
remaining to be collected under the SEPY arrangement is Clover. And just in which you'll see in the 10Q 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 backstopped by SEPY. So we expect to collect those amounts, you know, in the next few years as Clover collects on their commercial agreements with China and through other bilateral arrangements. Got it. Very helpful. Thank you, guys. Thank you.
our advancing pipeline and our strong financial position. I'd like to thank our team at DITABax for their continued dedication, the patience in 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 have 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. Thank you.