Q3 2023 Valneva SE Earnings Call
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Good day and thank you for standing by welcome to develop even nine months 2023 financial results call. At this time all participants are in a listen only mode. After the speaker's presentation, there will be a question and answer session.
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Like to hand, the conference over to your Speaker today, Joshua Drumm VP of Investor Relations. Please go ahead.
I think in Europe.
Yes, you are coming through thank you.
Oh.
Great.
Yes.
Good day and thank you for standing by welcome to even nine months 2023 financial results call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session. SaaS question. During the session you will need to press star one on your telephone.
Then youre an automated message advising you had disagrees please be advised.
Today's conference is being recorded I would now like to hand, the conference over to your speaker today, Joshua Drumm VP Investor Relations. Please go ahead.
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Hello apologies for the delay.
Thank you for joining us to discuss it on EBIT <unk> nine months 2023 results and corporate update it's my pleasure to welcome you today. In addition to our press release and analyst presentation. You can find our consolidated financial results for the nine months ended September 32023, which were published earlier today available within the financial reports section on our Investor website.
As always I'm joined by Bill Niebur, CEO, Thomas Winkelmann, and CFO, Peter Buhler, who will provide an overview and update of our business as well as our key financial results for the first nine months of the year it'll be an analyst Q&A session at the conclusion of the prepared remarks.
Before we begin I'd like to remind listeners quickly that during this presentation, we'll be making forward looking statements, which are subject to certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by these forward looking statements you can find additional information about these.
These risks and uncertainties in our periodic filings with the Securities and Exchange Commission and with the French market Authority, which are listed on our company website.
Please note that today's presentation includes information provided as of today November 19, 2023, 2023, and Boniva undertakes no obligation to revise or update forward looking statements, except as required by applicable securities law with that it's my pleasure to introduce Thomas to begin todays presentation. Thank.
Thank you so much Josh and.
Good day and welcome to our.
Nine months financial report and general business update.
Let me start with all R&D highlights.
We are progressing with the aiming towards potential licensure of the world's first.
We'll get a vaccine.
We have we don't see that the <unk> towards the end of this month.
Online believes that phase III study by the wall with Spyder continues cohort. One competed spritzig season, and current cohort two is 19 voting.
As previously discussed we have re initiated the Zika vaccine development and anticipated clinical trial starts early next year.
On the commercial business.
With total product revenues of more than 100 million euros, we have seen an almost.
Two weeks in Queens on non Covid fade as compared to prior year period.
And as such we are on track to meet our 2012 between stated guidance of $130 million to $150 million.
We remain to have a strong cash position with cash of 171 3 million Euro at the end of September.
Let me go straight to chikungunya.
As you know dip is our product candidate called DNA 55, three a live attenuated vaccine candidate unmet FDA priority review.
It is depressed cyclically can have vaccines that reported positive phase III data on Friday endpoints we.
We submitted the BLA.
In the meantime, also filed with the European Medicines Agency in Canada.
And the vaccine has very distinct features we demonstrated long lasting ico response of pressing the shops.
We see already 100% response, after 14 days and the favorable safety profile.
Got little Friday infections, as recently reported as part of the study in.
Children in Brazil.
We are preparing for launch.
We're investing in.
Making sure that we can supply the product as early as possible.
And as previously described a BLA 55, three especially from a traveler perspective fits perfectly within our existing commercial infrastructure, but also the industrial infrastructure.
By way of reminder, we see different markets on that non endemic meaning.
Travel is military and upright cabinets in the western world and debit to use that.
It might be where we have partnered with to AE and instituted for Triton.
You may remember that of course, the single largest short term rewards on this development program is the potential.
Walk in phase of the Pov upon BLA approval, which we are still included in our financial projections the level of roughly 100 million dollar.
The ongoing study in Brasil in adolescents, we reported already a positive initial safety data and final image.
Immunogenicity and safety data on the cohort part a is still expected this months.
With regards to the development outlook.
We continue to work collaboratively with FDA to align on our calls who will pay swap program.
And we have additional studies ongoing meaning antibody persistence study.
We will really follow through quite at least five years.
And the two year time point, it's still expected towards the later part of this year.
And.
The adolescent trial data is expected to support the potential label expansion of licensure for Neil.
But also supported too.
To really.
Add on to the existing licensure processes, especially with the European made medicines agency.
Anticipated future prides willing to Quebec, the nation pediatric specialty population and as mentioned face for effectiveness.
Turning onto line page number eight.
This is our multivalent <unk> recombinant protein based vaccine candidates addressing nine believed the oney Lyme disease program in advanced clinical development to date.
It's exclusively what by partner with Pfizer.
And we have to face, we well underway, which.
Which is sponsored by Pfizer and supported by positive resides for three phase III clinical studies, including the first pediatric and adolescent data, including prime boost.
And animistic response a top.
It is.
As we have reported multiple times.
M Hicks of aliens, so six valent vaccine that depresses, the most provinces where types, causing lyme disease.
In the northern Hemisphere, and that's why.
This vaccine really targets.
People.
Living in risk areas Lyme disease on both sides of the Atlantic. It is Robert Derisked program. Since it follows established modes of action for Lyme disease vaccine candidate at wax shown early on it.
At prospect designated by U S F D eight.
<unk> 9000 participants in the pilot Hoggatt population meeting every one about five years of age randomized one to one vaccine against placebo and two to one.
And between North American and European side.
Primary endpoint greatest contract Lyme disease after took a negative six seasons, meaning of the prime boost.
And the secondary endpoints include the rates offline disease. After the initial risks like these muni primary explanation.
Or in other words sweet primary doses.
And then other secondary endpoints as defined in the same suite protocol.
We have two cohorts.
As mentioned before.
The cohort one it's entirely enrollees.
It's now expecting.
<unk>.
The next booster shot prior to the season 2024, and the enrollment of cohort two is well well underway.
If everything goes to plan, probably the aims to submit regulatory applications in the United States and Europe in 'twenty 'twenty six.
In terms of trial updates we have two studies that are currently ongoing.
The value of vaccine efficacy study.
As I just described.
And and basically year, we expect the last subject out.
Towards the end of 16 and 2025 when.
The first issue readout is expected in parallel there's also pediatric safety study ongoing.
The first subject in achieved in December last year.
Enrollment was completed in summer of this year.
It's more than 3000.
<unk> run there.
And we target completion by the end of this year.
There will be the Palazzo periods as well.
Turning to CCAR page 11 of the presentation.
We have decided to reactivate this development.
Of a takeout by respecting candidate.
Knowing the theme in our experience on metro transmitted diseases, but also diseases that may be developed under an accelerated approval pathway.
CCAR viral disease remains a significant a very significant unmet medical need.
We believe that given this best of special target population for a potential takeout.
Vaccine that.
Our technology.
Leveraging the proven and licensed by prompts for HCR one the one in five but also the Covid vaccine Barak 2001.
May provide an excellent vaccine solution for this disease.
And as mentioned before.
We plan to Reinitiate.
The phase one early next year based on updated formulations that can have.
Looking overall at the pipeline of Bolivar page 12.
If need be focused strongly on the two late stage assets that we just mentioned.
With T cut back into.
The active clinical development program.
We continue door.
Evaluate partnerships for our <unk>.
H MPV candidates and successfully completed the preclinical proof of concept.
We are currently focusing our preclinical resources mainly on.
Epstein Barr virus and with that overall business update.
Especially focusing on R&D I would like to hand over to Peter.
Thank you Thomas and good morning, and good afternoon to all of you now let's look at the financial review for the third quarter of fiscal year 2023.
Product sales reached $106 1 million euros and grew 42, 6% over the same period in the prior year.
At constant currency product sales grew 45.8 defense. The strong growth is driven by all product lines with ixia aren't growing at 119.4% over prior year with $126, 7% at constant currency to Corral Atlanta 42, 7% at constant currency and third party product at 61, 1%.
This excellent sales performance is primarily driven by the recovery of the private travel market, but also by price increases across the board.
COVID-19 set vaccine sales at the end of September are unchanged from the end of June and Ray to a pre existing contract with the kingdom of Berry.
Moving on to the income statement total revenues reached 111 8 million euros versus 240 909 million euros in the first nine months of 2022.
In the prior year, while never had recognized significant other revenues derived from its Covid program, which explains this decrease.
Looking at expenses, we observed a significant decrease in cost of goods and services from over 200 million euros in the nine months of 2022 to $74 8 billion euros at the end of September 2023.
<unk> cost of goods and services were heavily impacted by one off items related to the wind down about COVID-19 program.
The cross matching of both <unk> and to Corral is still below pre COVID-19 levels, but improved versus the first half year cost.
Cost of goods are adversely impacted by ex Europe, I tried often our Scottish manufacturing sites and high sales volumes in direct and indirect markets, where our average selling prices lower and indirect mortgage.
In addition cost of goods include a total of $9 3 million euros related to the launch preparation of the company's chikungunya vaccine candidates.
Research and development expense decreased from $75 4 million euros in the first nine months of 2022 to $42 2 million euros in the current year.
Decrease is exclusively driven by the lower spend about Levered Covid vaccine program.
At the same time the cost related to the Zika vaccine candidate increase that the company has been working towards iridium initiation of the clinical development program.
Marketing and distribution expense increased significantly year over year from $13 1 billion euros to $33 9 billion euros.
The increase is mainly related to higher prelaunch cost for our proven approach, particularly linear vaccine candidate that more than tripled versus <unk>.
In addition, I agree with you spend at a positive impact related to employee share based compensation.
G&A expense increased to $23 3 million euros in 2022 to $35 1 million euros in 2023.
Prior year, all expense lines of the favorably attract for a total of $30 5 million euros related to employee share based compensation driven by the share price development.
The increase in other income from $7 5 million euros to 17 million euros is mainly related to the recognition of a grant received with Scottish enterprise.
The company's operating loss is stable versus last year at negative 57 million euros.
Net finance and tax income expenses reported a negative point 12 or at $1 1 billion euros versus negative 42 million euros in the prior year.
The lower cost is related to high unrealized exchange losses in the first nine months of the prior year.
So two locked for the year reached negative 69 million euros 30 minute less than in the prior year. Finally, we reported cash and cash equivalents at September 32023 of 171 million euros compared to $289 million at the end of December 2022.
This position includes an additional $50 million drawdown on existing credit facility with Deerfield Bogeyman. It takes into account significant payments made to Pfizer in relation to the phase III <unk> study below.
Now moving onto slide 17 drove your guidance for the fiscal year.
We reiterate our guidance for revenues and other income communicated early this year, we expect productivity to reach between under the 3200 50 million euros and other income to reach between 90, and 110 billion euros, assuming a sale of the chikungunya purely at the fiscal year 2023.
We reduced our guidance on R&D investments to 60 to 60 to 70 million euros versus 70 to 90 million euros previously.
This concludes the finance section of this call and I would like to hand back to Thomas for the upcoming catalysts.
Thanks, so much Peter.
Yeah. So this brings me to the point of summarizing really what they have to expect.
Over the causes in the coming months.
Akshay can go down.
First of all and most importantly, the bluebird slate.
What's the potential PNA, who will by the end of this month.
On track for that.
The adolescence image, Mr. Xie and final safety data from part a.
Also still dismantled.
And then the additional two year antibody data please be reminded that we reported a one year.
Follow up data sufficient data on last December so therefore.
We expect our core data on the two year time point in December and then the ACR P recommendation.
That is still planned for February 'twenty, 'twenty, four which of course is critical.
Toward the future potential commercial success of chicken vignette, Ashwin traveller and U S. Reckless.
Online.
Continued strong execution, it's very critical that.
If we have the enrollment completed for the core tools, so that we have all necessary.
Subjects in the study ahead of the 'twenty 'twenty four tick season mended. The next real catalysts for lime will come at the end of <unk> see it in 2025.
With the readout of the primary end point and at the same.
At least one or two of the first secondary endpoint. Additional news flows include defense granting of fate of the FDA per acre review voucher upon approval of DNA system suite, the initiation of our Zika vaccine developments.
With a new phase one start early next year and further advancement and exploration of selected preclinical programs.
With that we.
We are concluding that part of the presentation. When we look at the future strategic development of the company.
We see really very substantial strategic growth opportunity for by Veeva. This includes on the one hand side maximizing the existing travel vaccines leveraging continued recovery of travel.
To pre COVID-19 levels and beyond from a volume perspective.
And.
Then of course, the potential label expansion for BLA 55, three our chikungunya.
Vaccine candidate after initial approval in adults and pools and all the necessary.
Market.
And as we have said.
Multiple times.
We also looking into opportunities potentially in licensing.
While partnering or acquiring additional clinical stage assets to leverage our proven an excellent R&D capabilities.
And with that I would like to conclude our presentation and hand back to the operator to take your questions. Thank you.
Thank you.
As a reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced please standby as we complete the Q&A roster.
Okay.
Yes.
Okay.
Our first question comes from the line of Maury Raycroft Kraft of Jefferies. Please go ahead. Your line is open.
Hi, Thanks for taking my questions and congrats on the progress.
Yeah, I was going to ask one about your game Guinyard zero at the recent October ACI P meeting.
The Chikungunya Committee draft recommended vaccination to adults traveling to all break areas. However, they expressed some concern over the size of the safety population to detect rare adverse events as well as I use of Immunogenicity as the endpoint.
Post marketing outbreak studies should address both of these points, but I'm wondering if by size of the safety population is also is something being discussed with FDA heading into the produced by and separately will be outbreak study being in the works be sufficient ahead of that February ACI P vote, Ormeau ACI P want additional progress.
Yes, our evidence.
Before they make that boat.
So maury.
Excellent question, So first of all.
The safety database.
Supporting licensure.
And otherwise we would not be where we are at this point in time.
Of course, the program is or will be licensed.
Under the accelerated approval pathway.
So this means the accelerated fluid pathway by definition uses a surrogate.
And therefore immunogenicity data there is nothing one can do about it.
Of course, we got a true real world effectiveness.
As part of the Phase four and then and of course, there will be also dedicated to carry both safety follow ups.
Once the product is used in the eye with a larger cohort.
And this is all being.
Being part of the ongoing.
A discussion of non deal with part of the ongoing protest with the F D. A.
And we'll of course formed the basis for the anticipated licensure B b.
The agreement on phase four.
Protocol and conceptual design is mandatory.
For licensure and therefore, the exact design.
Will be also available to <unk>.
And <unk>.
And as such.
We'll.
We'll also make clear to ACI P. What they will and can expect in the years to come.
Around as the variance off of that.
Chikungunya BLA 50 next year.
Got it that makes sense. So the having the study design for <unk> should be sufficient.
For them out of the road.
Bob.
This is what we are this is our current working hypothesis, yes.
Okay.
Makes sense and then.
Is there any other perspective, you can share on our interactions with FDA and frequency of interactions ahead of the approval as it relates to the outbreak study and potential label discussions I just wanted to check if you're saying anything on that.
No I think I think of course, I mean, you will understand Murray.
You know this business well enough, we can and will not comment on.
An ongoing interactions with the agency. It is fair to say that of course as we are now on the what I'd say to the team all the time on the last mile of the marathon.
We are.
We have very intense.
And high frequency interactions with the agency as we jointly tried to conclude this entire process on time.
Got it makes sense and maybe last question for me just for a lime cohort two it sounds like enrollment is going well there.
When should you have there the cohort fully enrolled in order to get the required initial doses for next season, one for that cohort I guess is there any perspective on timing you can share on that.
So basically basically dairies.
Airbus cannot.
Necessarily a hard stop date on all of that.
But I think as you know we aim to have <unk>.
People fully immunized and having.
You know ideally peak tighter.
Optimized against the peak of the peak season, and this gives you a little bit of a perspective, given the schedule zero to take and the fact that we see that an antibody titer.
At highest level around month, Devon, and this gives you a little bit of a prospect and and given that the tick.
The tick season, yet has a peak, but there is also this phone the fracture legs left and right. So that gives you a little bit of flexibility around around that go into early next year I would say.
Got it okay. Thanks for taking my questions.
Thank you we will now take our next question. Please standby.
Okay.
Our next question comes from the line of Ed White of H C. Wainwright. Please go ahead. Your line is open.
Okay.
Good morning, Thanks for taking my questions.
So just on the travel market, maybe I can ask a big picture question.
And.
We continue to say you're seeing recovery in the travel market can you give us a good comparison on your thoughts for 2024 versus pre COVID-19 levels.
And then also just on X Oreo.
With a $32 million D O D contract.
Were any sales recorded in this quarter, if you could break that out for us.
And also how we should be thinking about the cadence of that contract.
Should it be fulfilled by the end of this year or should we see the impact going into next year as well.
Hum.
No I think I think so so basically let me let me answer would be that the travel market question first.
This is a very good question, indeed, and as they have said.
Multiple times when we look at it and Peter reported this also when we look at volume.
Because because at.
Also.
<unk> been able to leverage price increases, we need to look at volume and compared it to pre COVID-19 levels.
There are countries.
<unk> is being sold where we are indeed back to pre COVID-19 volume levels already today.
Also countries, where we are above pre COVID-19 volume levels today.
And there are other countries, where we are not yet.
Corbett volumes and.
There's a lot to do with travel behavior.
Generally we see a trend towards <unk>.
Higher awareness.
And and <unk>, but it is.
Very difficult to two.
Clearly model I.
I mean, we really do hope that we can see.
Next year in the back vast majority of countries.
Volume back or a box.
Pre COVID-19 level.
And this is really the outlook that we're going to take.
On the military contract and then and then let interrelated as base something about what's what page numbers, we have recognized the military but generally the contract with the Vod is a one year supply contract.
And therefore, you know the supply schedule and by the way we have already demonstrated first shipments at the supply schedule is of course, a supply schedule that spans over.
One year and not necessarily at fiscal year right So and.
Is it a supply plan is also subject to potential changes, which we continue to respond to <unk> upon the request.
The BLE.
You don't have the numbers, yes, maybe just so we had our first shipment to the U S. Military indeed in the third quarter, we have not disclosed the number in this quarter that said, we are actually now aligning with U S. Military on the on the supply schedule for the rest of the contract and we might disclose a number set in the fourth quarter, but so far we haven't.
Yes.
Okay. Thanks for taking my question.
Thank you we will now take our next question. Please standby.
Yeah.
Our next question comes from the line of Evan Wang of Guggenheim Securities. Please go ahead. Your line is open.
Hey, guys happy to see that.
Recommendation that answer Danny encouraging and argue.
Particular implications for I guess, both risk and exposure risk merchants to be positive for I'm sorry are you.
Interested in hearing your thoughts on the draft recommendation as well as how youre thinking about how.
The reclamation will look internationally.
Well. This is a this is a list.
But what you're asking is a little bit crystal ball reading cell. So first of all.
I mean the.
On a positive note as you rightly pointed out.
Our team recommended explanation right, which of course is already at its draft recommendations, it's great news.
They have in the drop in.
Included are kind, a few caveats to Ed Ed.
And define.
What really people at risk of Chikungunya may mean.
But please keep in mind that the draft recommendations and and so this is an ongoing process.
And it should be an ongoing independent process and not something where we.
Our intimate the mostly provide information we provide design will provide the data.
And but overall.
We see.
This going into the right direction.
With regard to other.
Hum.
The regulatory bodies other recommendation bodies.
I mean first of all you know that everything the regulatory authority.
<unk> is taking.
Slightly different stance when it comes to interpretation of data.
So therefore I think.
The basis or potential recommendations may be different in different geographies.
On top of that we have learned and.
And I personally have learned it's Adam.
So my more than 30 years in the vaccine Ministry that.
It's a different recommendation bodies take very different approaches so it's very difficult to predict at this point in time.
Other regulatory bodies, you know be it in Canada or be it in Europe or even beat in other territories.
Will will.
Our position.
Taking one yet we continue to believe.
That chikungunya.
Representing a major unmet medical need.
And therefore, we see a benefit.
To provide.
A vaccine solution.
Great and I had a follow up in terms of HPV assay. I know you guys are seeking a partner there and we're seeing a pretty robust initial launch and Arts me. So it seems like HMD.
Interesting program.
Can you help us think about.
How youre thinking about partnering discussions and.
The scope and type of agreements you are looking at thanks.
This is also of course, a very good question I think as you have rightly pointed out I think the RSV market is expected to.
Transition towards an RSV HBV combination markets when it comes to vaccination strategies and explanation solution.
Vaccine solutions.
And.
Therefore, we decided not to.
To develop <unk> as a standalone clinical asset.
Right now we are looking at different.
Partnerships.
Opportunities.
And it spans across a pure straight out licensed thing all the way into potential you know others head of drug.
Drug development structures and the like but it is too early at this point in time to guide really what is going to be.
What we can say is we have multiple parties under CDA and we have.
And we are exploring opportunities to you.
Okay.
Okay.
Thank you we will now take our next question.
Please standby.
Hello.
Our next question comes from the line of Simon shows the first Berlin. Please go ahead. Your line is open.
Yes, good afternoon, congratulations on the strong numbers.
I was just wondering if you could.
Let me know which of your planned future chikungunya trials.
We will generate 15 day onset of immunity data for inclusion.
On the label subject to approval and how soon you might be able to get that data onto the label.
So it's all right now I mean as you know the when we started the development of Chikungunya, we we haven't reached that.
<unk> endpoints.
Any amongst after explanation.
Of course, we had our and we have already published data.
That show an early onset however, as data were generated from from earlier studies and therefore.
As soon as they got to start the neck, Bobby and the next study is probably.
Gonna be a study in immunocompromised them.
We will include.
Earlier.
Imminent immunological endpoint.
In order to verify what we have seen already in prior studies, namely that we got ahead.
And the name of the <unk> levels of past the anticipated protective special somewhere in between day eight in <unk> and we will of course include that so that we can use this.
Data from.
From a well controlled phase III study in order to amend the label.
As soon as possible.
Okay. Thanks very much.
Thank you we will now take our next question. Please standby.
Okay.
Yeah.
Our next question comes from the line of severe Sameer Giovanni <unk> from <unk> Securities. Please go ahead. Your line is open.
Hi, guys.
Thanks for taking my questions Congrats on a good quarter and.
Congrats on the AC draft recommendation.
Got a few questions I'll, probably kick off on on that first.
One of the bullets highlight studies recommended.
For our somebody traveling to a church you where there is a chikungunya outbreak and I'm just wondering as we sit today.
Which territory would you say is the most important that's currently exhibiting a chikungunya outbreak. So I guess, that's the first question.
[laughter] semi excellent question. So I think first of all I mean the question is.
Is it an area where there has been an outbreak or is there an area where there is an actual outbreak.
Or is it an area, where there might be an outbreak coming up very soon it is not 100% clear from.
From what has been dropped it thus far.
And and it is.
It is very it's also not clear.
How outbreak is defined.
And and so basically today as you know we have seen.
Outbreak literally in every single country in South America.
But we have also seating you know.
Geographically.
I would say the <unk> outbreak in the southern part of Europe.
We have seen it and transfer it to leave in Italy and Spain.
So I think.
This whole definition neurons.
With the outbreak outbreak risk.
I think there is a need for refinement and four position I would say and we hope that this will come.
As part of the further.
ACR peaceful says leading then finally too.
Bolt in.
Temporary.
Is there a resource where a traveler can go online and no if theyre going somewhere that theres a chikungunya outbreak.
In terms of actual outbreak I mean, the only thing that I'm aware of is that company at all report.
Generally outbreaks and outbreaks.
But but also here we have a different definitions of.
Of outbreak so I'm not aware.
That there is a real standardized kind.
Kind of information platform, but I will be very happily take this as a follow up action EMEA.
And and get back to you on that one.
Okay. That's great. Thanks, very much and then maybe a couple of questions for Peter.
Cause a significant reduction in the refund liabilities on the balance sheet and significant payment was made in the quarter.
Assuming it looks like there's going to be a similar payment made for Q4, just correct me if I'm wrong on that and then once that's payments be made how far are you away from being capped out in terms of your.
Liability adviser.
Yes, I mean, that's a great question, obviously so.
And we as we said you know when I talked about cash I did mentioned that the.
This cash situation at the end of September takes into accounts as Mexican payments to Pfizer.
Now you see how the refund liability in our balance sheet is reduced how.
How much we pay in Q4 and thereafter, we have not guided and so I cannot disclose it of course of this call, but we've always said we will be done opinion, particularly for run a line in the first half euros may of 2024.
Okay, Great and then final question just on the finance expense, Peter and Keith three specifically Q3.
That went up quite a lot and is that just I.
I think <unk> talked about them.
No you're right.
Cash asset for Athene.
Is that just the translation effect again in Q3.
Yeah, that's absolutely correct, it's Playstation attract it's basically effect between U S dollar and U S.
Okay, that's great alright, thanks very much.
Thank you.
We will now take our next question please standby.
Okay.
Our next question comes from the line of Max Herrmann of Stifel. Please go ahead. Your line is open.
Okay.
Great. Thanks, very much for taking my questions three if I may.
Firstly just on on the Chikungunya program.
Conceptually, how how would you just John I'm trying to get my head I'm trying to understand this faithful commitment and how.
How would you conduct a logistically a an outbreak study.
Okay, and chikungunya, given the frequency and the uncertainty about which region it will be.
That's the first question.
Second is just on again trying to get a conceptually about the boost.
Dose.
With the Lyme disease via late 15.
Juice do think Germany dated now whether it would be a seasonal boost.
Bruce that you would need or how frequently.
And obviously the trial design requires booster.
Yeah, but do you think that is the right way to go forward or where would you need the booster and then finally just on the Zika just in terms of re instigating that program what was the kind of commercial evaluation that was done in order to.
<unk> scale that program what are the metrics you've used to I believe it is.
As a significant commercial opportunity that thank you.
So number of quick questions, Mike, Let me start with chikungunya.
I mean of course as you rightly pointed out.
<unk> business means that you need to.
<unk> provides the vaccine in a in a country where or in the region, where you have either actual outbreak or where the virus is really prevalent and you see a high chance of not break. This is why we are partnering with Instituto Ventana and J P. M.
Because we believe that the best visibility for all of that will be Brazil.
And and we are.
And this is also part of the protocol and it.
Takes into consideration that you have a certain set up ready.
And that will then go into.
A real.
Break life situation with with the study.
On your on your question around booster.
Of course this is a very important question I mean, you know that the boost of explanation as shown in the photo op studies from pace to generate a very high end domestic response with immunogenicity levels significantly very significantly above.
Priming.
So this means whether we we will need to boost the every year or every other year or every third year or.
What it's really going to mean.
Only this question can only be answered.
Post efficacy study.
And once we see hopefully a correlation in between imminent submit the T and efficacy.
And that would then inform what kind of immunological levels need to be reached.
In order to have a meaningful.
For predictive of efficacy.
And that's why we continue doing the antibody persistence studies.
I'm with the primarily to phase four phase two cohorts.
To inform that.
Four months about about this situation on CCAR.
I would like to remind everyone. So what is what is really the.
And we have been explaining this along a couple of times.
So point number one.
Okay.
I we have.
Decided.
We initiated.
Two main reasons number one is we see an emerging.
Absolutely logical.
Development around CCAR.
We see you see for example in India.
CCAR cases significantly added right.
You see also.
Hearing their arthritis on on Zika virus prevalent in other countries.
And and B B.
The evidential issue.
Our blueprint and widespread paper around.
The fact that.
<unk> CCAR vaccines, they recommend them.
Inactivated toward virus and or recombinant protein based vaccines, given the tolerability profile for vaccines the Clos.
So that's the reason why we said let us.
Go into that.
We have also said that we kind of monitor.
I would say the the medical or the unmet medical needs, meaning D. The wheel.
Development of the epidemiology over to quality next year.
We have built certain commercial model that we need to refine those models and we set only.
If there is a continuous development on the medical need side.
And subsequently a favorable commercial.
Opportunity we will continue.
Continued clinical development post the initial phase one and this we have also publicly disclosed.
Alright, Thanks, very much just just in terms of the field study just to understand a little bit more and I know you obviously haven't been having lots of detailed discussions with the FDA about this but are you thinking about choosing a region, where there are have been recurrent chicken patients and then setting up.
Our program, there and just kind of waiting for a F.
An outbreak or are you looking at some sort of a quick response to an outbreak where you can vaccinate. The population that in reality you can think about it it's almost a combination of the two things that you have just yet but the way you can think about it yes.
Okay.
Great. Thanks very much.
Thank you.
There are no further questions speakers. Please continue.
Yes.
Well that concludes our presentation today. Thank you all for your participation.
Just note that there will be an archived version of the webcast available on our website later today.
Thank you everybody.
This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
Yes.
Yes.
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