Valneva SE Q1 2023 Earnings Call

And then we have to cohort two which is.

Pfizer reported around high 50% of the study subjects had to be abandoned now you see on the slide and end of 9000.

Which answers your question.

And then when we talk a little bit about the strategy going forward.

I think.

Yes, it is unfortunate that we.

Same thing.

One year delay.

The land programs compared to where we were but let's not forget that the the.

Underlying signs the underlying strength of this product candidate.

It's certainly still something that has not changed.

And even if someone started tomorrow with a clinical development for our Lyme disease vaccine.

It will still be the same clinical development program.

What we need it and we know how long it takes.

So therefore, we don't see necessarily any change in strategy in connection with that.

The other options.

Of course when you.

When you think about what had happened.

It was primarily U S focused so we have evaluated up cost.

Going.

It's of course, EG Europe first and then use later.

Or.

Changing primary versus secondary secondary or primary all of that has been a long process.

Excellent collaboration and consultation in between the two parties and supported by external parties.

And ultimately we decided to keep everything of this.

And just at <unk>.

In addition, CT.

Great. Thank you.

Chikungunya for the mid cycle review you mentioned that there is no significant review of our safety concerns just wondering if theres any other points that were discussed that you could comment on that have implications for the review process label or post approval studies.

Not at this point in time.

Great. Thanks, I'll hop back in the queue.

Thank you.

We will now go to your next question.

And your next question comes from the line of Mike Thompson from Stifel. Please go ahead.

Alright, great. Thanks, very much for taking my questions.

Uh huh.

Congrats on the quarter just wanted to.

Understand a little bit about the pre commercial activities for the chicken vaccine. What are you. What are you doing what are your plans and then also on the cake.

In terms of Afib meeting in February .

Should we be expecting a few phases of.

That review or do you think you can get a clear decision with one meeting.

That's the first question just on following up on the question with regards to line, but just wanted to make sure that that 9000.

Looting that 9000 subjects is excluding any.

Of the GCB.

Kind of.

Patients or subjects that Eric.

Were recruited.

But that one.

And then final question on commercial notice usually you have a strong fourth quarter in a strong first quarter with a travel vaccine business I noticed subsea.

But <unk> and other vaccine areas were down quarter on quarter fourth quarter to first quarter I just wanted to get an understanding of that.

Stocking patterns or what was what was the cause of that given.

Clearly we still.

Seeing a recovery in travel.

Thank you.

Very good question smacks, Shanghai, so basically.

And try to go to address them as good as I can the 9000 line exclude of course.

<unk>.

Excluded from the study.

Particular launch.

I mean.

Our debt.

We are investing heavily.

We are investing in.

People processes and infrastructure.

Market access.

<unk>.

All the stuff that you would expect for <unk>.

Our prelaunch phase.

Really getting everything ready in time.

To get to make the launch success and ensure that we see.

And over time, a rapid uptake of the vaccine.

<unk> is key.

Around around all of that and this requires resources.

Human resources to other receptors.

Maybe you see this already in the decrease in marketing expenses and as well.

We'll continue.

Then on the.

The whole Afib thing I mean, right now the vote date is set for <unk>.

Temporary.

There has been already a couple of steps.

And there are still a couple of.

Additional steps planned.

More we cannot predict.

At this point in time doesn't mean that that we may not see additional steps here and there but this is ed.

Far as we can tell at this moment in time.

On the commercial dynamics. Please keep in mind quarter, one has still been affected by it.

Supply shortages on the money market and not only on the volume effect also on third party content.

So it is at this at this moment it is very.

Very difficult to.

To predict or to draw a conclusion on the pattern <unk> seen this year are.

Two prior years.

Therefore.

We would like just to remind everyone that we have again reiterated the product sales guidance for the year to reach 132 on that.

Great. Thanks very much.

Well couple of months.

Thank you.

We will now go to our next question.

And your next question comes from the line of Ed White from H C. Wainwright. Please go ahead.

Hi, Thanks for taking my questions.

No.

It's an.

H MPV.

Had mentioned.

And before that you could partner.

Looking at an RSV combo I'm, just curious as to if you've actually had any interest in.

In that and if that's something we can expect to see.

This year or is this just some time down the road that we should be thinking about this opportunity.

Excellent question. So basically we are we are having active discussions around H MPV.

But it is.

Far too early.

To promise a partnering deal.

We are.

We clearly see that.

That's.

Now for a top of the mrna companies priced parts.

Our sweet <unk> PV combos.

We also see the immediate medical need for RSV HBV combos.

But there are only a certain number of <unk>.

Obviously companies that could.

Have a potential differentiation.

Adding an HPV component to the vaccine, but as I said.

It is.

It is too early this is why we are saying.

We are evaluating partnering but we're not promising partnering at this point in time.

Okay. Thank you and just on <unk>.

Check.

How should we be thinking about a potential for.

A doj contract or the size.

Perhaps the stockpiling for.

Outbreak preparedness is this going to how are you thinking about this opportunity because it is it immaterial or.

It's a material opportunity for the company.

This is this is a very.

To ask a question so we have.

I mean, you know that we have been pretty clear about our expected.

Effective market opportunity in the travel segment.

In the <unk> countries.

We have not been specific at all.

Round the size of a potential military business.

Nor have we been privet decide.

Around timing.

We we.

We have discussions with the U S military as well as with certain countries to face.

Essentially interested in stockpiling.

At this point in time those segments do not represent.

A major chunk of our overall projections.

But it is too early to really.

Gift, giving.

Giving guidance or give a range for those opportunities I think we should probably postponed it to next year same time myself. Once this product is.

Approved hopefully in the market.

We will have a very much much greater understanding about those opportunities.

Okay. Thank you and my last question is just regarding the two different cohorts for the study now.

Are you considering these.

Pfizer are considering these cohorts as different studies with the same study.

Can you release the data from the cohort one fire to cohort two or do you have to wait for those cohorts to finish to release the data.

No. We are currently expecting that we kind of believe so first of all this is one study.

And in <unk>.

Second we are currently expecting towards this is altogether.

Okay, great. Thanks for taking my question.

More than welcome.

Thank you.

We will now go to our next question.

And your next question comes from the line of Evan Wang Guggenheim Securities. Please go ahead.

Hi, guys. Thanks for taking the question.

One alignment.

Danielle.

With wine as we're thinking about the additional courts being enrolled.

Well that'd be entirely.

U S focus or a majority of U S smokeless just given.

Zero.

Ah patients.

And for Chikungunya, just following up on the stockpiling opportunity. There I believe you have had some congress early conversations are there any color you can provide in terms of the feedback gone is there any kind of additional studies or bottlenecks that you know.

May need to be addressed first thanks.

So online.

Additional cohorts.

In Canada.

So no.

Enrollment in Europe .

For chikungunya and the whole stockpiling as I mentioned, we have discussions ongoing at this point in time, we do not expect.

Further studies than the one that we have already planned.

Please keep in mind, we have planned.

Besides the pivotal studies have concluded.

Adolescence.

The phase III adult and of course the other.

Lesson than later could you asked Rick we have lots of plans in immuno compromise.

<unk>.

I know co vaccination studies.

But we're not necessarily expecting dose to become a predictor of it.

For a potential stockpiling I think it would more be question one the final.

Our recommendations will be there to final approvals will be there.

<unk>.

And the thing that would be the moment, where we.

We got to get more clarity.

And Thats certainly important.

Got it if I could just squeeze one more in you know in terms of the potential business development and licensing.

Three realistic or is that more of a longer term.

Yes.

Yes for us it is a 2023.

Objective.

And but it depends on the opportunity right.

So.

So we would see any set this objective for this year for the organization for ourselves.

And we hope that we will be able to achieve that.

At this point in time, we have multiple things that we are reviewing and evaluating but as I said.

A deal is done when the deal is done right I mean, we cannot.

We cannot be sure that this is going to materialize this year.

Great. Thank you.

Thank you.

We will now go to our next question.

Okay.

And your next question comes from the line of Tom <unk> from Goldman Sachs. Please go ahead.

Hi, Thanks for taking my questions.

So I guess firstly just on <unk>.

Given the strong start for the travel vaccines and <unk>.

2023, and given the Courtenay format. So I was just wondering how confident you are in reaching the upper end of your sales guidance.

And then secondly, just on Japanese.

Given that there was a competitor vaccine, which was acquired by a private company. If you kind of talked about expanding.

Global registrations.

<unk> I was just wondering if you could discuss your thoughts on the on the market and how you are kind of people to defend your position that thanks.

So let me take the second question and then if the first car to feature.

So look I.

I mean.

At this point in time.

We have not seen any.

Competitor for J E initiating the necessary clinical studies.

For a registration in Europe and U S.

And there was no way.

<unk>.

You can register.

This competitive product without irrespective clinical study.

And endo as well.

Take time, and I think we were going to deal with it.

When we see.

<unk> competitor entry.

In terms of positioning.

Our vaccine.

Has a more than 10 Years' history is it is a vaccine that is marked by excellent effectiveness.

And safety.

And it's a very well known and established brand.

And as such we feel strong about this product we feel strong about its prospects.

And we would also feel strong about it if we had a competitor injury.

Which is not on the horizon at this point in time from.

Where we stand at this point.

Peter do you want to say something about guidance yes.

Thanks, Roxanne for the question.

Look I think we're very.

Domestically and we consider ourselves I think as you said with a very strong first quarter.

In line with pre pandemic level in Euro terms.

Of course. This this is great for the rest of the year also and as Thomas said, we still had some supply constraints in Q1. So we are very.

Domestic with regards to reaching our guidance whether it will be the upper part of the guidance I think it's too early to tell but we certainly had a good start.

Thank you.

Thank you.

We will now take your next question.

And your next question comes from the line of Samir <unk> Rx Securities. Please go ahead.

Yeah, Hi, guys. Thanks for taking my questions I think I've got a couple.

Just going back to the.

Successful mid cycle with the Thomas I, just wanted to get any more color as to whether there was a lot and it could be a type a meeting or not.

First question.

And then the second one is really just on.

Faiza <unk>.

Collaboration you Havent booked any recognizing revenue in the P&L. This quarter. So I was just wondering if you could help us understand whether we should still expect me to recognize anything for the remainder of the year.

What sort of magnitude and also I think lost in the last call you talked about.

Your contribution coming out of a refund liability that doesn't seem to have been much change in your view.

Fund liabilities on the balance sheet could you just confirm whether there's been a significant payment made during the quarter for the R&D contribution. Thanks.

Okay. So some yes.

Again mid cycle review.

We have not.

Mentioned anything about <unk>.

And we have not mentioned anything about any roadblock.

This should be giving you the right answer I think.

And then on.

On the regulatory recognition contribution liabilities I hand over to Peter and his team.

Yes. Thank you.

So on the revenue recognition you're right we have not recognized any revenue there could still be going forward.

Some revenue that we could recognize potentially which we've decided not to do so far as long as the phase III trial is still.

When a relatively early stage and ongoing but we certainly have some.

<unk>.

I think on the refund liability I think your observation is very is very good. So there was I think we will.

With the overall situation on the line I think there were some I would say delays in issuing invoicing. So we indeed have not paid us much in Q1, as we would've anticipated and Thats why probably you haven't seen a lot of moving the refund liability. So there will be a catch up.

In the later part of the year, but it doesn't change the overall.

The cost base, we had previously we had estimated earlier on.

Okay. That's very helpful. And then let me sneak in one more just on your third party product sales and they were quite a lot lower than they were in Q4 could you just.

Explain to us what's going on there and what we should expect for the rest of the year. Thanks.

Yes look as I said before I think.

When I look at it.

We are in Euro terms in line with where we were pre pandemic. So I think it's a very strong quarter I think it's in line with our expectations and we are optimistic for the rest of the year to deliver our productivity within guidance of 130 250 million euros.

Okay. That's great. Thank you very much.

Thank you.

Yeah.

And your next question comes from the line of Simon Skulls first Berlin. Please go ahead. Your line is open.

Yes, Hello, I've got two questions.

I remember in the last call.

You are discussing that.

A more create a creative solution might have.

With the FTA much of allows you to submit documentation already as to what is.

Early 2025.

The loss of trial participants.

I'll just be very curious to if you could discuss what that creative solution might have entailed.

Secondly.

Can you give us any indication on when can you.

Can you tell us whether you expect the supply constraints, which hit the travel that you will travel vaccine business in Q1 to ease.

Thanks.

So.

First of all not so sure whether I recall, having set created.

As I mentioned I answer the same question earlier on in life I think we have evaluated the possibility to.

To take especially soft cost earlier.

But after a capital risk benefit evaluation.

Have decided that it is not in the interest of this program.

Two.

To increase its risk profile.

On the supply constraint side of things.

Yes, we have.

What we had anticipated.

<unk>.

Have a long lead time too.

Produce the vaccines and when we saw last year.

Beginning recovery.

Okay. Thanks very much.

Hello currently no further questions I will hand, the call back to <unk>.

Yeah.

But it's.

The remainder of the day bye bye.

Thank you. This concludes today's conference call. Thank you for participating you may now disconnect.

Yes.

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