Q3 2024 MediWound Ltd Earnings Call
Good day and welcome to the medical third quarter 2024 earnings call. All participants will be in a listen only mode should you need assistance. Please signal conference specialist by pressing the star key followed by zero.
Speaker Change: After todays presentation, there will be an opportunity to ask questions to ask a question you May Press Star then one on your Touchtone phone and Swift Joy. Your question. Please press Star then two please note. This event is being recorded I would now like to turn the conference over to Mr. Dan Ferry of life Advisors. Please go ahead Sir.
Thank you operator and welcome everyone.
Speaker Change: Today before the market open medical and issued a press release announcing financial results for the third quarter ended September 32024.
Speaker Change: You may access that release on the company's website under the investors tab.
Speaker Change: With us today are all forgotten Chief Executive officer of that alone Honey, Luxembourg, Chief Financial Officer and.
Speaker Change: Barry Wolfensohn executive Vice President of strategy and corporate development.
Following our prepared remarks, we will open the call for Q&A.
Speaker Change: Before we begin I would like to remind everyone that statements made during this call, including the Q&A session relating to Betty wounds expected future performance future business prospects or.
Speaker Change: Sure events or plans are forward looking statements as defined under the private Securities Litigation Reform Act of 1995.
Speaker Change: Although the company believes that the expectations reflected in such forward looking statements are based upon reasonable assumptions actual outcomes and results are subject to risks and uncertainties and could differ materially from those forecasts due to the impact of many factors beyond the control of megawatt.
Speaker Change: The company assumes no obligation to update or supplement any forward looking statements, whether a result of new information future events or otherwise.
Speaker Change: Participants are directed to cautionary notes set forth in today's press release as.
Speaker Change: As well as the risk factors set forth in med one's annual report filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward looking statements.
Speaker Change: The conference call is the property of metabolic.
Speaker Change: And then he recording or rebroadcast is expressly prohibited without the written consent of megawatt now.
Now I would like to turn the call over to Ofer, <unk>, Chief Executive officer and that it wont ofer.
Speaker Change: Ofer.
Ofer: Thank you Dan and good morning, everyone.
Ofer: I appreciate you joining us today to discuss maybe once performance and progress during the third quarter of 2024.
Ofer: This is being a strong quarter for maybe one marked by meaningful achievements that contributes to our long term growth and advances us closer to realizing our vision.
Let me start with an update on Nexobrid, our innovative and thematic therapy for severe burns.
Ofer: This quarter, we reached a significant milestone with FDA approval nexobrid for pediatric use in the United States expanding its label to cover patients from newborn to 18 years old.
Ofer: With deep partial thickness and full thickness thermal burns.
Ofer: He is a proven solidifies nexobrid status as a treatment option for all age groups with United States, bringing its indications in line with those in the European Union and Japan.
Ofer: Okay.
Ofer: Commercial revenue of Nexobrid has met expectations.
Ofer: Only by our existing capacity constraints.
Ofer: In the United States next with continues to make substantial progress thanks to very self dedicated commercialization effort.
Ofer: More than 70 burn centers have already made PMT committee submissions of which approximately 50 I already securing approval and placing initial orders.
Ofer: Additionally, Nexobrid recently received a category three CPT code, which is scheduled to be posted on the a M. A website January 1st and go into effect July 1st next year.
Ofer: Barry said has also reported an impressive 43% quarter over quarter increase in revenue of Nexobrid, reflecting its expanding impact in the United States burn care market.
We are also excited to share that the world Health organization W. H O.
As recently.
Ofer: Eh designated enzymatic debridement as an essential treatment for burn injuries.
Standard recommendation for burn care in mass casualty incidents guidelines.
Ofer: This reinforces nexobrid crew she had a role in emergency response, and a global preparedness and strengthen ongoing initiative to develop strategic stockpiling of Nexobrid in the European Union.
Ofer: Building on the successful precedent set by bought that in the United States.
Ofer: As we shared before we have also completed construction of a state of the art GMP compliant manufacturing facility with commissioning currently underway.
Ofer: The facility is expected to reach full operational capacity by the end of 2025.
Ofer: And to increase our manufacturing output six folds.
Commercial availability will be contingent upon obtaining the necessary regulatory approvals.
Ofer: Yeah.
The company anticipates, a $20 million in revenue for 2024 compared to prior guidance of 24 million.
Ofer: Next up with product revenue remains in line with expectations driven by strong demand that well exceeds current manufacturing capacity.
Ofer: However.
Ofer: The F D. A approved nexobrid pediatric indication without requiring any additional post approval activities.
Ofer: This eliminates the need for BARDA funding for such activities and reduces the associated revenue.
Ofer: Additionally, following a type C meeting with the F D. A clinical activities for the temperature stable formulation of Nexobrid for the U S. Army have been scheduled for 2026, which postponed the associated contribution from the U S Department of defense.
Ofer: To conclude demand for Nexobrid continues to grow driven by U S expansion via very so F. B, a pediatric approval and inclusion in the W. H O B M C I guidelines.
Ofer: Our new GMP facility set to increase capacity six fold with support this rising global demand and revenue growth.
Speaker Change: I will now turn to S correct.
Since it might take debridement therapy for chronic wounds.
Speaker Change: We have completed all preparations for the upcoming Phase III study Oh first correct in venous leg ulcers, marking a major step forward in addressing an unmet need in the 2 billion chronic wound debridement bucket.
The study is set to commence with IMD submission planned by year end.
Speaker Change: This pivotal trial will evaluate the efficacy and safety of S. Correct and aims to establish it.
Speaker Change: That's a transformative treatment for VA to use.
Speaker Change: All set up activities for the trial have been finalized including successfully passing very quiet EMA inspection, ensuring compliance with regulatory standards and readiness to initiate this study.
Speaker Change: To provide insight into this upcoming phase III study.
And to the broader commercial potential of S. Correct, maybe want to host virtual key opinion leader event on January eight 2025.
Speaker Change: During the event experts will discuss the trial design objectives and highlights S correction dissipated impact on patient outcomes.
Speaker Change: In parallel we are working with a third party research firm on a comprehensive market analysis to.
Speaker Change: We refine our understanding of the potential market share.
Speaker Change: Segments across various kill settings.
Speaker Change: Rising star strategies.
Speaker Change: <unk> projected peak sales.
Speaker Change: We look forward to sharing the findings of this analysis alongside expert perspective during these kols events.
In addition, we're preparing to launch a randomized head to head phase two study of S correctly versus collagenase in 2025.
Speaker Change: This trial is designed to support that would be a nice submission and further establish S correct fifth competitive advantages.
Speaker Change: This study will enroll 45 patients across multiple sites in the United States and Europe.
Speaker Change: But these events will be randomized into a one to one to one ratio to receive S. Correct placebo or collagenase, which is marketed in the United States at Santana and in Europe as you rock salt.
Speaker Change: Over a 14 week period, the eschar exemplar subgroups will receive up to eight daily application. During the first two weeks, while the collagenase group will follow the product specific instructions for use.
Speaker Change: The trial will evaluate the key safety endpoints, including the incidence of severe adverse events and time to complete wound closure as well as other efficacy endpoints such as time to complete debridement and one bed preparation.
To ensure consistency and optimize patient outcomes. This study standardizes won't care and compression management made possible through strategic research collaborations with some wenzel and more leaky.
We have also obtained 16 point 25 million euros in funding from the European Innovation Council to advance the development of S. Correct for the Abitibi for DOCSIS accelerating a program timelines but for years.
Speaker Change: With over $1 6 million via a few patients in the United States, requiring debridement each year they.
Speaker Change: This funding will afford us the opportunity to bring a potential new treatment to this currently underserved patients facing the risk of amputations infections and deaths from defused complications.
Speaker Change: Preparation for the phase two three study in those patients are progressing well.
Speaker Change: We're excited about the potential to impact the U S corrects, how impactful these improving outcomes for substantial patient population.
Speaker Change: So as far as correct. We are finalizing the NDA submission for the new patients setting the stage for the initiation of the phase III trials.
Speaker Change: Furthermore, the upcoming head to head study comparing S character collagenase alongside advancements in the recently funded the a few program.
Speaker Change: Solidify S corrected position as the leading solutions address critical unmet needs in the chronic wound market.
Speaker Change: Yeah.
Speaker Change: Having summarized there were significant progress with both Nexobrid in S. Correct I'd now like to highlight the key strategic and financial milestone.
Speaker Change: This quarter, we secured $25 million through a private investment led by mall Nicky Health care.
Speaker Change: Which is a global leader in the <unk> field. This strategic partnership provides not only critical funding, but also access to a molecule has extensive commercial expertise and regulatory insights, enabling us to advance our strategic plans with greater focus and momentum.
Speaker Change: Now I'll hand, it over to honey to briefly review our financials.
Yeah.
Speaker Change: Okay.
Speaker Change: Thank you Elsa.
Speaker Change: Let me now take you through our financial results for the third quarter and the year to date period of 'twenty 'twenty four.
Speaker Change: Revenue for the third quarter of 2024 totaled $4.4 million compared to $4 8 million in the same period of 2023 D.
Speaker Change: This decrease was primarily driven by lower revenue from out of that development services.
Gross profit for the quarter was 0.7 million, representing 16% of total revenue compare to 0.9 million or 19% of total revenue in Q3 2023.
Speaker Change: This decline reflects change in the revenue mix.
Speaker Change: Turning to operating expenses.
Speaker Change: R&D expenses were $2 5 million in Q3 2024 up from one 5 million in the same period last year.
Speaker Change: As we ramp up activity for our pivotal.
Speaker Change: Phase three clinical trial.
Speaker Change: SG&A expenses totaled three point.
Speaker Change: Pardon me it seems that our speaker line has disconnected.
Speaker Change: Please hold while we reconnect.
Speaker Change: Yeah.
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Speaker Change: Yeah.
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Speaker Change: Okay cool.
Speaker Change: Yeah.
Speaker Change: Pardon me, we ever management team to reconnect you May proceed.
Speaker Change: Okay moving on.
To date for names said hi, Thanks for the first nine months of 2024, sometimes when you reached 14.4 million.
Speaker Change: So I think one 3 million in the same period of 2020 to me, primarily driven by revenue contribution from them instead.
Speaker Change: Gross profit for the first nine months was $1 7 million or 12% when you compare to $2 9 million or 21% of total and the new <unk> in the first nine months of 2023. This reflects the same changes in revenue mix.
<unk> mentioned earlier.
Speaker Change: In terms of expenses.
Speaker Change: R&D expenses of $5 9 million slightly higher than $5 7 million in the same period of 2020 suite.
Speaker Change: SG&A expenses of $9 1 million up from eight 8 million in 'twenty to 'twenty. Three we then by increased share based compensation costs.
Speaker Change: Operating loss for the first nine months of 'twenty 'twenty four was $13 3 million compared to 11 point some million in the same view in 'twenty 'twenty suite.
Speaker Change: Net loss for the first nine months came in 26 points being union or to $72, yeah compare to a net loss of 5 million or 56 cents yeah.
Speaker Change: Shane.
Speaker Change: In 2023. This increase was largely driven by financial expenses. So believe modulation of Swan, which were influenced by a remarkable 78% increase in <unk> share price and to date.
Speaker Change: On a non-GAAP basis adjusted EBITDA for the first nine months of 'twenty 'twenty, four or the loss of $9 9 million compare to add it up from 9 million in the same period last year.
Speaker Change: Balance sheet highlights.
As of September 32.
Speaker Change: So I think plentiful, maybe one maintain a strong financial position with cash cash equivalent and deposit totaling 46 million.
Speaker Change: $42 1 million, if you earn plenty plenty to me.
Speaker Change: During the first nine months of 2020 full we successfully raised 25 million type of Tony.
Speaker Change: One 2 million from the exercise of series, a one and fully settled our liability was data we use.
Speaker Change: It was $19 7 million to fund our operating during the period, including 6 million allocated to capital expenditure for the scale up of our many sections proceed.
This concludes my financial review I'll step back to you.
Speaker Change: Thank you Sammy.
Sammy: This has been a very strong quarter from 91 marked by significant progress in key achievements.
Speaker Change: We secured FDA approval for the pediatric indication of Nexobrid and raised $25 million in strategic funding.
Speaker Change: Yes, correct font, we finalized population for the phase III study in venous leg ulcers.
Speaker Change: Generated plans for diabetic foot ulcers addressing that market.
Chicken unmet needs.
Speaker Change: We are also doing up or head to head trials, that's correct versus collagenase.
Speaker Change: To validate this correction.
Speaker Change: What's that dish.
Speaker Change: Additionally, the completion of our new Mexico blade manufacturing facility and the <unk>.
Speaker Change: <unk> of the commission costs.
Speaker Change: Major milestones and scaling alcohol scaling our global capacity.
With these accomplishments we look forward to a strong finish of the year and believe that's maybe one is well equipped with the resources partnerships and momentum.
Speaker Change: <unk> strategic plans and deliver meaningful value to patients and stakeholders.
Speaker Change: With that I'll now turn the call back to the operator for any questions operator.
Thank you we will now begin the question and answer session.
To ask a question you May press Star then one on your Touchtone phone, if you're using a speakerphone. Please pick up your handset before pressing the keys. If at any time. Your question has been addressed and you would like to withdraw. Your question. Please press Star then two and at this time, we'll pause momentarily to assemble our roster.
And the first question will come from Josh Jennings with Cowen. Please go ahead.
Josh Jennings: Hi, Thanks for taking the questions.
Josh Jennings: I appreciate the sort of download.
Speaker Change: Oh I was hoping to just ask about the phase III, yes, correct.
Speaker Change: <unk> submission.
Speaker Change: Anything you can share any color on your interactions with the FDA.
Speaker Change: It seems like with the Kols and then timing early in January.
Speaker Change: That much pushback in terms of some of that submission.
Speaker Change: You could see an approval of that.
Submission pretty soon after it but when should we expect a trial enrollment to kick off I guess is ultimately.
Speaker Change: My question, just any any interaction with the FDA your confidence at design. This play will go through.
Speaker Change: When should we expect enrollment to begin.
Speaker Change: Okay. So hi, Josh in that thank you for that for the question. So as you.
All know this trial is the most significant and comprehensive trialling for Ya.
Speaker Change: Ah patients in over two decades.
Speaker Change: Why are the wound care companies are collaborating with us and interested in the specific endeavor.
Speaker Change: We spent some time with the FDA to discuss the potential eh protocol with them and with Irma and we were able to be cleared by.
Speaker Change: S P a M M.
And we are in the process. We also were inspected by Emma before you start the phase III trial. This is something that is required before you ship.
Speaker Change: Clinical batches and overseas.
Speaker Change: You're from Israel, and so we have we had this and inspection and we passed successfully.
The submission is expected.
Speaker Change: Imminently by like by the end of this year and 30 days after that we expect to start enrolling patients.
Excellent thanks for that.
Speaker Change: Wanted to ask about the head to head phase two study.
Speaker Change: We're supposed to college in Asia, Central and <unk> patients.
Speaker Change: I mean, our assumption is this.
Speaker Change: Originated in timeline.
Speaker Change: But.
Just wanted to check a box of just is not a requirement by the regulatory bodies in the U S or Europe.
Speaker Change: This is just a study that will bolster the evidence Oh, that's correct Paul.
Speaker Change: Chronic wound care and.
Speaker Change: <unk> supports reimbursement decisions.
Speaker Change: So.
The main the main eh.
Speaker Change: And motivation for exactly what you described is that we are four years away from launch and we want to be ready.
Speaker Change: That bad debt will support.
Speaker Change: Hi revenue as possible and so the main reason for doing it.
Speaker Change: First of all to read.
Speaker Change: So they determined after yoga analysis.
Speaker Change: Posted a post hoc analysis that we had in the previous week.
Speaker Change: We did it.
Speaker Change: At least the data.
Speaker Change: Sandeep.
Speaker Change: Second we want to expand the deficit that we have and we want to show all of our advantages are for us for our society.
Third we wanted to include.
Speaker Change: Our.
Speaker Change: That's correct.
Speaker Change: Bryan also versus your sort of renewables, because you're right, we have Glenn who reports to having good food.
Speaker Change: Globally and not just in the United States. So we don't have data yet versus New York.
Speaker Change: This is another reason that you are doing just that.
Speaker Change: In Europe and in the United States.
Speaker Change: This strengthens our position.
Speaker Change: And give us the head stock index for the commercial launch I saw the requirements from the S. T E. We are now.
Speaker Change: Completing the full package I did said Andy you are doing the phase III study that we need to come back, but we have all kind of small studies such as the PK study and the human factor study and all kinds of data.
Speaker Change: In order to make sure because once the phase III study is successful we have all the relevant data in order to have this drug approved.
Speaker Change: Got it and lastly, one more question just on Mexico grid, just wanted to make sure we were digesting.
Speaker Change: Justin Yep.
Speaker Change: Mr Fracturing capacity.
Speaker Change: These initiatives has there been any changes since the last earnings call just in terms of timing.
Speaker Change: Uh huh.
Speaker Change: Having a capacity increase of benefit anymore.
Speaker Change: Can you just review that and if there has been any changes maybe just help us understand thanks, so much for all the questions.
Speaker Change: So this is a very important question so for ask for a new manufacturing facility in Mexico bid.
Speaker Change: No that it took us some time to bring data to close more than two years. Since we started the process. We guided that we would finish the construction by mid year and we did it and now we are in the process that was pre.
Speaker Change: Our pre planning process, which is called the commissioning.
Speaker Change: We are getting closer to that point in time, when we need to qualify inspections for both F. D. A.
Speaker Change: The reason that we gave them a little bit more color.
Speaker Change: Basically to make sure that they know that we are now we have some dependency on the updates getting closer on our inspection.
Speaker Change: That's why we mentioned it in this induce that'd be cool.
Speaker Change: Great. Thanks, so much.
Speaker Change: Thank you.
Speaker Change: The next question will come from French's breeds ball with Oppenheimer. Please go ahead.
Speaker Change: Hi, This is Dan on for Frank Thanks for taking our questions. Thanks for all the color around the trials just as a follow up to the phase III head to head.
Speaker Change: Parsons collagenase.
What should we how should we be thinking in terms of some success our expectation.
Post hoc showed potential superiority over Santo.
Speaker Change: Designed in a similar way the ninth where you're already any any color there. Thanks.
Speaker Change: That's it.
Speaker Change: An interesting question so high and.
Speaker Change: They just have to watch that day is.
Speaker Change: Pretty much designed and.
Speaker Change: And similarly.
Speaker Change: The previous phase two that was a success the only.
Speaker Change: The thing that is different is that we.
Speaker Change: We don't get an auction for the centers to treat with autolytic debridement of all kinds of concerns.
Speaker Change: It would be prudent adoption they have only two options they can treat with X correction or they can treat with some people and of course a placebo.
Speaker Change: What we should expect and this is what we expect is to see a.
Speaker Change: Similar effects, because we know that the santee, though we hope so.
Speaker Change: Right.
Speaker Change: Basically two no do not too much effect in.
Speaker Change: In the first two weeks when we do Brian that's correct. The only thing we wanted to do is to see the same impact this is a.
Speaker Change: To be clear defined study.
Speaker Change: So the doctor that we'd be generated here can be used more credibly when we started discussing our pricing with the relevant entities.
Thank you that's very helpful and just one more follow up could you talk about any you know what how you expect a what's the impact of the suites. In addition of the WHI inclusion.
Speaker Change: It's a with respect to stockpiling or does it accelerate any of the timelines that you.
Speaker Change: You had in mind. Thank you.
Speaker Change: So now that we're thinking about the you know we're concluding any brand that we are working I think for the last two years in order to have it be cheap to be to include enzymatic debridement is an essential treatment.
Coal burn injuries in mass mass casualty incident is a big achievement for.
Speaker Change: And for Us.
Speaker Change: When you discuss stockpiling with Heather, which is the which is the European borrow that.
Speaker Change: And it was.
Speaker Change: And event or check the box that you needed to pass.
Speaker Change: We are currently under a shortage, we don't have enough.
Speaker Change: Nexobrid to ship to stockpile to one kind of European countries, but now we're getting closer to that we believe that in 2026.
Speaker Change: That went a limitation of manufacturing will be beyond us. We believe that then we wouldn't be able to sign significant agreements with European countries and we've had with here in order to have a mix of blades stockpiled in Europe for all kinds of emergencies.
Speaker Change: Thank you thanks for taking my questions and congrats on the quote.
Speaker Change: Thank you.
Speaker Change: The next question will come from RK with H C. Wainwright. Please go ahead.
Speaker Change: Thank you and good afternoon for honey.
Speaker Change:
Speaker Change: So.
Speaker Change: In your opening comments you were talking about category three CPT.
Speaker Change: C P J code, so oh, how how do you anticipate.
Speaker Change: Getting benefit from this and what needs to be done so that your brick and mortar category.
Speaker Change: Again, I think in the short term I don't think it will have any direct impact to the penetration of our Oh.
Speaker Change: Nexobrid to the U S market I think because.
Speaker Change: It does cause husband motivation to.
Speaker Change: Acquired Mexico blade, regardless of specific codes, because it's a better treatment and it saves money to the breadth of itself. So I don't think it will have a real impact, but you know this is a positive.
Speaker Change: Breakthrough new technology Ah that there should be gathered.
Speaker Change: And let's see the impact that would happen to make sure even if you're in the next 12.
Speaker Change: 12 to 24 months.
Very good and then regarding the debt you have to study that you're anticipating to start with.
Speaker Change: The money that you received from the European authorities.
Speaker Change: What needs to be done there before we can start thinking about.
Speaker Change: So for instance to the anticipation.
Hum in the ex U.
Speaker Change: So, although we have a quite significant data about the effectiveness of that's correct on that.
Speaker Change: <unk>.
Speaker Change: Oh, yeah, but you've put out there.
Malcolm stated that we have.
Speaker Change: So Boston rehab on demos play boxes.
Speaker Change: Sandoz is six.
Speaker Change: 16, 65% success after two weeks or we didn't see any advantage to this indication could be other thoughts.
Speaker Change: We have less data.
And then maybe it's too soon for this indication so what we should do is to write the protocol.
Speaker Change: Oh made sure that all the key opinion leaders, both in Europe and India.
Speaker Change: It's all aligned with the programming the necessity and the treatment scheme.
Speaker Change: Perhaps for this indication we need to get clearance from FDA and DMA and we believe that this will not lessen.
Speaker Change: Yeah.
Speaker Change: How we estimate it.
Speaker Change: Okay and then the last question for me is.
Speaker Change: Regarding the type C meeting that you had with the D. A about the temperature stable formulation of an extra but what did you learn from that.
Speaker Change: What what needs to be done because you're saying you're going to start the study.
26, I'm, just trying to understand what needs to be done between now and then.
So mainly we have two main activities in this program. The first one we are building a specific facility will enable us to manufacture.
Speaker Change: Tell him a theory as to this.
Speaker Change: Phase III trial.
Speaker Change: We're building this facility to be constructed a mixture.
Speaker Change: Next year.
Speaker Change: Operationally in 2026. This is the first to the second.
Speaker Change: The FDA asked us to all kind of a non clinical developmental background and so on.
Speaker Change: We're working on the CMC in order to make sure.
Speaker Change: Sure.
Speaker Change: Mexico, Good compass temperature stable population.
Speaker Change: Very close to Nexobrid in order for us to meet minimum ortho clinical trial, and we don't want to you don't want to develop.
Speaker Change: The drag from zero, so we need to cope with the agency, but those products are very similar and we estimate that this process will enable us to start the clinical trials in 2026.
Speaker Change: Okay. Thank you thanks for taking all my questions.
Speaker Change: Thank you.
Speaker Change: Next question will come from Michael Acuna, which with Maxim Group. Please go ahead.
Thank you guys, taking my question today.
Hmm.
Speaker Change: I guess just to follow up on our case question there.
Speaker Change: Do you have a sense of what I'm clinical work is going to be needed to get the temperature stable form relation approved.
Speaker Change: Do you expect that that'll just be a single relatively small trial.
Speaker Change: This is all expectations, we set with the shelves.
Speaker Change: The program with the agency.
Speaker Change: Oh God.
Speaker Change: We didn't get negative responses. So yes. This is what we expect.
Speaker Change: We are able to finish the Montana plan and the CMC request that they have.
Speaker Change: He said, we estimate that between data for clues.
Speaker Change: Yeah.
Speaker Change: Alright, Thank you and then.
Speaker Change: Looking over to the opportunity in Europe for Stockpiling, you talked a little bit about the size of that potential opportunity and then just given where the timeline wise is this something that could make sense to do with the temperature stable formulation given the advantages that has for stockpiling.
So.
Speaker Change: This is an interesting question since we are discussing different commented quite a lot. So I saw the potential of stockpiling there we didn't disclose the amounts.
Speaker Change: The size of the market.
Speaker Change: But it should be in the low tens of millions of dollars.
Speaker Change: Stockpiling and of course, we need to divide it by the by Sweden, because the shelf life of the club between years.
Speaker Change: Pilots Grove, Nexobrid warm temperature stable formulation.
Speaker Change: As only being developed.
And to the U S market. After we have clarity after we get clarity from the FDA.
Speaker Change: This is what we need is a small study.
Speaker Change: In order to allow this pool, we will go to the European Authority and moving off course, senior law and we're going to go with possibly but we're not there yet the discussions that we're having with.
Speaker Change: European BARDA, which is called <unk>.
Speaker Change: Ah well now analyzing the quantities we are defining exactly what the needs are and I believe.
Speaker Change: B matured only towards the end of 2025 and then in 2026, when we will not have any capacity constraints, we will be able to to start shipping products to Europe.
Speaker Change: Alright. Thank you and then just one more quick clarification question from me.
Speaker Change:
Speaker Change: Looking at the head to head study right what role is to prevent him playing is that is that the same as it is in the phase III for be all used.
Speaker Change: So maybe Barry Barry do you want to jump into this question.
Speaker Change: Sure.
Speaker Change: Yeah.
Speaker Change: Our primary goals and securing all of these collaboration agreements were to ensure that.
Speaker Change: And the phase III and in the head to head studies as much as possible.
Speaker Change: Our ability between study arms is minimized and to provide best in class products for the patients in our study.
Speaker Change: Compression therapy is the gold standard for the management of venous leg ulcers, and it's an essential component and all the validated a clinic.
Speaker Change: Clinical practice guidelines for this indication.
Speaker Change: Regarding solvent them, specifically the superior benefits of co band two and co brand through light were confirmed in our recent real World evidence retrospective study presented at both the symposium on advances in wound care and at the European Wound Management Association Conference. This past year, given the prominent position of this product in the market and we're quite pleased at.
Speaker Change: And we'll be supplying them for the patients in the study as they're doing the phase III as well along with providing investigators and their teams with the training required to use them appropriately.
Speaker Change: Alright, thank you for that.
Speaker Change: Thank you guys for taking my questions today.
Speaker Change: Thank you Michael.
This concludes our question and answer session I would like to turn the conference back over to Mr. Ofer for any closing remarks. Please go ahead.
Mr. Ofer: Well. Thank you everyone for joining us today, we look forward to continuing our dialogue and updating you on our progress during the next quarterly call.
Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
Speaker Change: Yeah.
Yeah.
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