Q4 2024 MediWound Ltd Earnings Call
Unknown Speaker
Speaker Change: Good day, and welcome to Mediwound Sports Quarter in 4 years, 2024, earning conference call. All participants will be in this early mode. Should you need assistance, please single a conference specialist by pressing the start key followed by zero.
Speaker Change: Medical and assumes no obligation to update or supplement any forward looking statements, whether as a result of new information future events or otherwise.
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Forgot: With us today are all forgotten Chief Executive officer of Matawan Honey Luxemburg.
Barry Wolfensohn: Chief Financial Officer, and Barry Wolfensohn, Executive Vice President of strategy and corporate development.
Barry Wolfensohn: Following our prepared remarks, we will open the call for Q&A.
Oh Forgotten: Now I would like to turn the call over to Oh Forgotten Chief Executive Officer of Matawan.
Barry Wolfensohn: Okay.
Speaker Change: Thank you Dan and good morning, everyone.
Speaker Change: 2024 was it people tell you from 81, Mike by marked by strong execution significant progress in clinical development <unk>.
Speaker Change: Commercial expansion and strategic partnerships.
Speaker Change: These achievements have strengthened our position and I think that's to drive continued growth and innovation in 2025 and beyond.
Speaker Change: I'll begin with S. Correct, our next generation as they might think they blackman therapy for chronic wounds.
Speaker Change: In early 'twenty 'twenty four.
Reported compelling results from our head to head analysis against fat to cut.
Speaker Change: Currently the only FDA approved and thematic debridement product into United States generating approximately $317 million.
Speaker Change: Got it.
Speaker Change: The data demonstrated as codexis superiority over sampling across key clinical endpoints, including higher incidence of complete debridement fastest time to complete debridement more rapid and effective one bed preparation and faster time to wound closure.
Speaker Change: Clinicians surveyed are cool diverse care things recognize these superior clinical benefits and the substantial value they provide.
Speaker Change: In fact recently conducted market research estimates S correct peak sales potential.
Speaker Change: $725 million for the primary indications.
Speaker Change: And diabetic foot ulcers.
Speaker Change: These clinical benefits also make S correct, well positioned for upcoming changes in wound care reimbursement.
Speaker Change: Starting next month Medicare LCD policy will acquire full wouldn't be Brian Mint, and granulation tissue formation before covering cellular and tissue based products.
Speaker Change: Shift strengthen S corrections opportunity as a major commercial opportunity for our company.
Speaker Change: That's correct now isn't it.
Speaker Change: We recently launched a new global phase III trial to evaluate that's correct for venous leg ulcers and falling 216 patients across 40 sites in the United States and Europe.
Speaker Change: The co primary endpoints of the trial or the cadence of complete bright and the incidence of wound closure.
Speaker Change: This program is strategically de risked building on the strong results of our phase two studies with key modifications to maximize the likelihood of success.
Speaker Change: Vacation that include a large patient sample size to strengthen statistical power.
Speaker Change: An interim analysis at 65% enrolment, allowing for adaptive adjustment and standardized treatment protocols to minimize variability and ensure consistency.
Speaker Change: Because it also important to note that the S correctly chairs the same active pharmaceutical ingredient does nexobrid, which is FDA approved for nearly identical indication eschar removal.
Speaker Change: The interim assessment a significant milestone is anticipated in mid 'twenty 'twenty six with full trial completion expected by year end 2020 six.
Speaker Change: To further strengthen our BLA submission and enhanced commercial readiness. We are planning a 45 patient randomized prospective phase two head to head comparison of S corrects versus collagenase scheduled to begin in 2025.
Study will include both sand hills, and the European Collagenase product evokes all generally think critical comparative data that will be instrumental in supporting market access and pricing strategies.
The video programming supported by strategic research collaborations with leading wound care companies sell then to bottleneck here and be medics.
Speaker Change: These partners will provide advanced wound care products for a trial, ensuring optimal patient outcomes and standardize wound management across all sites.
Speaker Change: Additionally earlier in 2024, we secured $16 5 million Euro funding from the European Innovation Center to.
Speaker Change: The development of that's correct for the big foot ulcers.
Speaker Change: The phase II three D. A few clinical trial is planned for 2026, and we're pleased to announce a new strategic research research collaboration agreement with Caris is a subsidiary of Cola plus to support this effort.
Speaker Change: Yeah. This is which is a global leader in wound care solutions will be supplying its facial skin graft for active closure in this trial.
Speaker Change: Additionally, we anticipate securing another collaboration with the major industry leader.
Speaker Change: To supply their market, leading advanced wound care dressings.
Speaker Change: With these partnerships, maybe one will be working alongside.
Speaker Change: All the relevant key players in the advanced wound care reinforcing our strong industry positioning.
Speaker Change: Now let's move.
Speaker Change: To nexobrid, our innovating and thematic therapy for severe burns.
Speaker Change: Before we discuss our fourth accrued progressing with Mexico breathe.
Speaker Change: To take a moment to highlight its critical real world impact.
Speaker Change: This past weekend, it devastated Knight nightclub fire in North Macedonia.
Speaker Change: 59 lives in Egypt at least 155 people.
Speaker Change: And medical delegation from Israel equipped with Nexobrid immediately flew in to provide support and treatment.
Speaker Change: We're grateful that Nexobrid can play such a vital role in this tragedy.
Speaker Change: With that said in 2024, we achieved significant progress in expanding nexobrid commercial reach gender.
Speaker Change: Generating annual revenue of $22 million driven by robust global demand.
Speaker Change: Moving forward, we anticipate continued strong growth with projected revenue of $24 million in 2025 cap only by our manufacturing capabilities.
Speaker Change: This growth will be driven by expanding sales in key markets in.
Speaker Change: Europe, where nexobrid is now available in more than 90 burn centers.
Speaker Change: Where our partner <unk> Pharmaceuticals has achieved a remarkable adoption with 400 class medical facilities using nexobrid.
Speaker Change: And the United States, well very strong commercialization efforts yielded a 42 increased 42% increase in hospital orders in Q4, 'twenty 'twenty four.
Speaker Change: Nexobrid markets potential with further expanded with FDA approval for pediatric patients newborn to 18 years old.
Speaker Change: If people it'll phase III pediatric study data supporting approve the approval. We recently publishing Burns the peer reviewed journal of the International Society for burn injuries.
Speaker Change: Another potential indication expansion emerge during the Israeli come mass war.
Speaker Change: Dozens of patients with blast injuries were treated with nexobrid.
Speaker Change: The outcomes were remarkable and the data from these cases will be presented at the upcoming American Burn Association conference.
Speaker Change: Additionally, we reported positive results for the expanded access protocol next which evaluated 239 patients across 29 U S burn centers.
Speaker Change: The study confirmed Nexobrid safety and efficacy, that's going mobile as well as its significant reduction in the need for surgical post teachers for burn patients.
Speaker Change: Operationally, we successfully completed the construction of our state of the art GMP manufacturing facility, which remains on track to reach full operational capacity by late 2025.
Speaker Change: Commercial availability will depend on regulatory approval from F. E M E, which are expected in 2026.
Speaker Change: This facility will significantly expand our production capabilities, allowing us to meet the growing demand.
Speaker Change: The growing global demand.
Speaker Change: Thin long term revenue growth.
Speaker Change: This year, we also strengthened our balance sheet with a strategic $25 million type financing round led by mall Nicky.
Speaker Change: This reflects industry confidence in our strategy and provide additional resources to execute our clinical and commercial growth plans with a robust robust cash runway of approximately $44 million.
Speaker Change: Maybe one is well positioned to deliver on its critical clinical operational and commercial objectives.
Connie: Now I'd like to turn the call over to Connie to review, our financial performance in greater detail.
Connie: Thank you Arthur and good morning, everyone I'll now take you through our financials at least that for the first quarter and full year of 2024.
Connie: Starting with the first quarter reported revenue of $5.8 million compared to $5 3 million in the same period last year.
Connie: Well I'll spell six came in at 0.9 million with gross margin of 15, 5% up from 0.7 million and 17, 5% margin in Q4 2023.
R&D expenses were 3 million compared to 1.8 million in the Swire Coca.
Speaker Change: I need you to cost related to the S correct value phase III right.
Connie: SG&A expenses per car.
Connie: Million compared to 2.8 million in Q4, 'twenty 'twenty, Lee, mainly reflecting higher share based compensation expenses.
Connie: This resulted in an operating loss of $6 1 million compared to three.
Connie: $3 9 million last year.
Connie: Net loss for the quarter was $3 9 million or 36 cents per share compared to $1 7 million or 19 cents per share in Q4, 2023.
Connie: On a non-GAAP basis, adjusted EBITDA loss was $4 9 million compared to $3 2 million in the same period.
Connie: Last year.
Connie: Now moving to full ear really posted total revenue of 25 2 million compared to $18 7 million in 'twenty to 'twenty three.
Connie: The increase was primarily driven by higher revenue from the resale and new contract with the U S Department of defense.
Connie: Gross profit for the year was two 5 million with a gross margin of 30%.
Connie: Compared to $3 6 million and a 19, 1% margin in the trial are the.
Connie: The decline was mainly due to changes in revenue mix and higher fixed costs associated with scaling our production.
Connie: R&D expenses came in at eight 9 million compared to seven 5 million in 2023, primarily due to cost related to escalate value phase III trial.
Connie: SG&A expenses were 13.1 million.
Connie: Impact to 11 6 million in 2023, mainly reflecting higher share based compensation costs.
Connie: Our operating loss for the year was $19 4 million compared to $15 3 million in 2023.
Connie: Net loss for the year was $30 2 million or $3.03 per share compared to $6 7 million or 75 cents per share in the I O N.
Connie: It might be 3.5 minutes each lease was primarily due to financial expenses, mainly from the revaluation of warrants following a 75% increase in our share price in 'twenty 'twenty four.
Connie: non-GAAP adjusted EBITDA loss for the year was 40.8.
Connie: <unk> 8 million compared to $12.3 million in 2023.
Connie: Don't think to balance sheet, we ended the year with $43 6 million in cash cash equivalents and deposit compared to $42 1 million at the end of 'twenty to 'twenty three.
Connie: You ended the year with.
Connie: We successfully raised 25 million through type offering.
Connie: The $1 2 million from the exercise of series, a warrant and secured $1 2 million grant from the European Commission.
Connie: We also fully settle our liability with Devon.
Connie: He thought that we used $22 9 million and operation, including 6.8 million allocated to capital expenditure.
Connie: Primarily for scale up of our manufacturing facility.
Connie: That concludes my financial review I'll refer back to you.
Connie: Yeah.
Barry Wolfensohn: Thank you Jaime.
Barry Wolfensohn: So in summary, 2024 was a transformative year for maybe one defined by significant clinical commercial and strategic achievements.
Barry Wolfensohn: Strong execution, expanding pipeline and key partnerships position us for sustained growth and long term value creation.
Barry Wolfensohn: As we continue to advance our programs expand market the book ship and drive innovation, our focus remains on delivering meaningful improvements in patient care.
Barry Wolfensohn: We look forward to providing further updates you know progress in the coming quarters.
Barry Wolfensohn: With that I will now turn the call back to the operator to open the line for questions.
Barry Wolfensohn: Operator.
Speaker Change: Yes, Sir we will now begin the question and answer session.
Speaker Change: So a question with Star then one on your telephone keypad.
Speaker Change: It has already been adjusted to remove yourself from cube, who's going to start them too.
Josh Jennings: Today's first question comes from Josh Jennings of Cowen. Please go ahead.
Josh Jennings: Hi, good morning.
Josh Jennings: Good afternoon, and thanks for them.
Speaker Change: Taking the questions and congratulations on the initiation of the value study.
Josh Jennings: Appreciate all the time.
Josh Jennings: We view the trial design in the past for one follow up with you would have some some powerful wound care.
Josh Jennings: Collaborators in this study.
Josh Jennings: So that's a molecule like <unk>.
Josh Jennings: Just wondering.
Speaker Change: What what is outside of supplying the wound care products for the study what else are they doing in terms of enhancing study execution.
Josh Jennings: One of the things that are at work.
Josh Jennings: No.
Speaker Change: So hi, Josh and thank you for the question Barry do you want to address it.
Barry Wolfensohn: Yes, Thanks, Josh asked another question Jeff.
Speaker Change: Generally speaking.
Speaker Change: Having standardized products across these three key categories, the moist wound dressings that compression bandaging and tissue substitute.
Speaker Change: Ill.
Speaker Change: Just to make sure that all variability.
Speaker Change: Is minimized throughout the study which of course, we'll optimize the outcomes as far as the companies themselves are concerned asides from the products that there'll be supplying they'll also be supplying training. So in fact this weekend in Philadelphia, we have our investigator's meeting and there'll be training of all the sites.
Speaker Change: Companies will be involved in and and on an ongoing basis. If there are any questions related specifically to their products don't provide that education and training.
Speaker Change: Excellent thanks for that and wanted to ask about the <unk> study.
Speaker Change: At the beginning of 2026.
Speaker Change: So I think it's in place too.
Speaker Change: Two part question launched should we expect it to be a global trial.
Speaker Change: With the EU funding similar to the <unk> study the value study.
Speaker Change: And then two maybe just outline what.
Speaker Change: Required just a similar pathway that you took for VR you in terms of getting trial design approved.
Speaker Change: By the FDA and EMA.
Speaker Change: Well the just sheer you walk us through that again, sorry to make you repeat it.
Speaker Change: So so so the first phase III study with a with a b a few patients will be will be.
Speaker Change: As close as we can to this phase III study of the pediatric patients. The only difference is that we have less data that we have for new patients. So in order for the agencies to agree to.
Speaker Change: To agree to the structure of the study we need to get to get their sign off our our plan is to approach both FDA and EMA in the second half of this year with the protocol that is based on the data that we have to date, we have a few thousands of patients that were treated with.
Speaker Change: We'd be a few patients and the data looks at basically similar to what we have would be a big deal.
Speaker Change: But we need to have it approved this is why when we guide about the study we say a phase two three study because maybe it will need what kind of an interim assessment and shifting to a phase a phase III down the road.
Speaker Change: Having said that we need to get clearance from the agency before we can give a lot of details.
Speaker Change: Our thoughts about how the study will look like is currently posted on our website and it looks quite similar to the virtual trials.
Speaker Change: With this trial, we will also have strategic collaborations the same as we have would be really a trial, but it will be with different partners.
Speaker Change: Excellent and then just one last one on that spread.
Speaker Change: We have made great progress in terms of.
Our GMP manufacturing facility in.
Speaker Change: Place and.
Ramping up the capacity this year.
Speaker Change: Understand that Greg.
Speaker Change: The regulatory approvals necessary for product to be commercially available just when is the earliest that regulators can get in to do an inspection and move forward with a clear answer I know.
Speaker Change: Don't have any control over or the timing, but.
Speaker Change: Like when is the earliest.
Speaker Change: Start that process it sounds like Youre expecting approvals in 26.
Speaker Change: So currently our guidance for the revenue all reflecting the fact that we will get at the beginning of 2026 approval in Europe and by mid 2026, we'll get a FDA approval.
Speaker Change: The thing that we need to have in place in order for those approval to take place is that we need to make sure that we are able to manufacture product with the same.
Speaker Change: Quality and.
Speaker Change: And the same cook realistic of the current manufacturing facility that we have which is quite smaller.
Speaker Change: After we finish proving that we can do the same we need to manufacture a few batches of both Mexico break for the United States and for Europe, Europe demand three months of stability after that that they come they can come from unexpected inspection. This is why we expect European approval to be earlier.
Speaker Change: In the U S F D a.
Speaker Change: The guidelines is that we need to wait six months of stability. So these are the timelines and this is why we guided in the beginning and in the middle of 2026, both approvals.
Josh Jennings: Thanks, Ofer, Thanks, Barry I appreciate it.
Speaker Change: Thank you.
Speaker Change: And our next question today comes from first of all it Bruce voice.
Speaker Change: Oppenheimer. Please go ahead.
Bruce Oppenheimer: Hi, Thanks for the question and congrats on the progress this year.
Speaker Change: 24, I was just wondering if you can touch base, you're starting to call. It talking about the Medicare update you just.
Speaker Change: Remind us when that came in place and how you know just a little more color on how do you think that is a positive for for many wound and then the second question is more on the interim analysis. Just a reminder, I think you mentioned it on the timing of that.
Speaker Change: Yeah.
Speaker Change: The phase III and what are the different kind of outcomes that can come out of this interim analysis. Thank you.
Barry Wolfensohn: Okay. Thanks for the question Barry can you step in to address the first question and I will answer the interim myself one one.
Barry Wolfensohn: Sure of course, so with regard to the Medicare question recently as you are.
Barry Wolfensohn: Likely aware the seven local macs or Medicare administrative contractors posted final changes to what's called an LCD a local coverage determination policy related to the usage of cellular <unk> tissue based products.
Barry Wolfensohn: <unk>.
Barry Wolfensohn: This category has exploded in the last several years several years.
Barry Wolfensohn: Two as high as 3 billion in the U S and while several dramatic changes were written into the draft policy as it turns out the final policy ended up not really too different than the current one this new policy becomes active.
Barry Wolfensohn: In less than a month on April 13th 2025.
Barry Wolfensohn: One key change is the slight limitation on the number of applications of tissue that can be put in place on a patient during one complete episode that number has gone down from 10 previously to four.
Barry Wolfensohn: It doesn't have the ability to do an additional four if the wuhan situation warrants additional applications and for these additional for the sites must complete some additional paperwork, but that extra work is not deemed to be too time consuming to keep them from doing so that's the bigger change that the industry.
Barry Wolfensohn: We will focus on from many of them perspective, and how it relates to ask Rx another meaningful change.
Barry Wolfensohn: This new LCD is the increased attention to documentation required showing that the wound is completely debride, it and covered in granulation tissue prior to application of any tissue substitute to the wound and given that this is what <unk> does so well at the brides and it gets wound bed the wounds prepared.
Barry Wolfensohn: This will position our drug as the optimal product of choice when surgery or sharp debridement is not deemed to be the best option.
Barry Wolfensohn: Yeah.
Barry Wolfensohn: Okay, very I have nothing to add to that Oh, Thank you for answering.
Speaker Change: I saw the interim assessment are I as I said in my in my prepared remarks. This program you strategically deal with very well succeeded in 14 out of 14.
Speaker Change: Studies, and we have no plans to fail in the most significant studies that we're conducting so we plan an interim assessment after 65% of the patient in the study which is 140 patients.
Speaker Change: The treated and.
Speaker Change: And the two outcomes to this assessment one.
Speaker Change: 90% that the there is a 90% probability of success the 90% powered for success is maintained.
Speaker Change: And in this case, we are stopping the enrollment of the study by them more than 200 patients will be already included in the study and then we just waiting for the follow up into studies done.
Speaker Change: If we see that the lack of likelihood of success is less than 90% lets say, 77%. We have some flexibility in the protocol to include additional few dozens of patients in order to maintain the 90% booked pud.
Speaker Change: Probability of success.
Speaker Change: Everything goes as we planned.
Speaker Change: The interim assessment should be by mid 2026, and the study completion, assuming there 90% probability of success is maintain the study completion is by the end of 2026.
Speaker Change: I hope I answered the question.
Speaker Change: Yep. Thank you.
Speaker Change: Great.
Speaker Change: And our next question today comes from RK from H C. Wainwright. Please go ahead.
Speaker Change: Thank you.
Speaker Change: Good afternoon offer and honey and good morning, Barry.
Speaker Change: A couple of questions Barrick.
Speaker Change: Barry Thanks for explaining the LCD them.
Speaker Change: The new L series, Yeah, you know who that is.
Speaker Change: Is it just going to become.
Speaker Change: Officials in a month so based on what you were saying regarding the granulation of the tissue.
Speaker Change: Is there anyway.
Speaker Change: At least if he can.
Speaker Change: Can compare for us.
Speaker Change: How sad to know performs a.
Speaker Change: Versus what we should expect from us correct.
Speaker Change: And.
Speaker Change: Based on that is S codex.
Speaker Change: Has potential to be better than than what Santana does right now.
Barry Wolfensohn: So Barry do you want to address it.
Speaker Change: Sure.
Speaker Change: Well a couple of things firstly, thank you RK for the question.
Speaker Change: <unk>.
Speaker Change: As you know we announced the results from this head to head Phase II study.
Speaker Change:
Speaker Change: Earlier this year.
Speaker Change: In S correct.
Speaker Change: As shown above stanfill and all of the key end points whether that was.
Speaker Change: Time to complete debridement incidents of complete debridement.
Speaker Change: And and also time to wound closure with regard to.
Speaker Change: The.
Speaker Change: So.
Speaker Change: So right there off the bat, if you're a treating physician and you have a wound that comes in and you want to get towards CGP for active closure youre going to know that the data suggests that <unk> can get to that.
Speaker Change: CGP.
Speaker Change: With only a couple of weeks that the average is going to be five to six applications.
Speaker Change: Within a couple of weeks and.
Speaker Change: Published data even outside of Samsung even outside of our.
Speaker Change: Phase two.
Speaker Change: This suggests that its more along the lines of.
Speaker Change: Six to eight if not even more weeks, so there's going to be in incentives.
Speaker Change: To use eschar X because it will get to that CGP application.
Speaker Change: Much more quickly than would chantal.
Speaker Change: Well, thank you for that and then Oh for.
Speaker Change: Question on the real use.
Speaker Change: The ongoing study.
Is there any possibility for this study to endo.
Speaker Change: You know quicker.
Speaker Change: Expect that so that we can.
Speaker Change: And expect data earlier.
Speaker Change:
Speaker Change: Whether it's the interim or are the final.
Speaker Change: Complete dataset later next year.
Speaker Change: Yeah, So hi, Okay and thank you for this question. Its a great question because I was asked about it again and again by my Board yesterday.
Speaker Change: I wouldn't expect a quicker enrollment are that many patients who are in the largest centers in the United States and Europe.
Speaker Change: A lot of patients that are available, but we are making sure that we are recruiting the right patients I want patients with real quick ones.
Speaker Change: You don't want patience with the Wanda, which is not that severe and even a placebo will do something.
Speaker Change: So we're spending a lot of time and a lot of effort in screening and making sure that no patient is getting into the study unless he has a real quality corn and will help lead one because our intention is that the federal will do I think to it.
Speaker Change: I don't mind waiting another month or another two months I'm not incentivising our centers to recruit as many patients as they can as quickly as they can on the contrary and just making sure. It's a very lucrative study.
Speaker Change: And wants to get.
Speaker Change: To be treated within theories that we're getting the most expensive dressings. The most success there that the most effective a pressure garments.
Speaker Change: We know that we will have the there was a.
Speaker Change: A lot of demand to participate in this trial.
Speaker Change: Our motivation is to make sure that it is done adequately and I would not expect a quicker enrollments.
Speaker Change: Okay. Thanks for that and then on the.
Speaker Change: In collaboration with BARDA in terms of identifying a new U S facility and and I'm trying to I'm trying to plan and design and facility.
Speaker Change: Stage.
Speaker Change: What is the status there.
Speaker Change: And also can you give us any color as to how you're going to manage these big projects like you just got done with the everyday Israeli facility and you.
Speaker Change: You know Oh, what's the timeline, if you so decide and and.
Speaker Change: Identify.
Speaker Change: Specific site in the United States and how does it play into the expansion of Nexobrid.
Speaker Change: You know from what you're you know yet to accomplish.
Speaker Change: That's already been signed up for.
Speaker Change: Yeah.
Speaker Change: So the facility in Israel that is going to be Uh huh.
Speaker Change: And full capacity by the end of this year and getting the approval by mid next year.
Speaker Change: Uh huh.
Speaker Change: We will have the capacity to support the foreseeable market of Mexico, buoyed, both in the United States and globally.
Speaker Change: Having said that the U S government recognizes the need to having to having a backup facility in the United States.
Speaker Change: So we are now in the pool. So we got some funding to identify location in a b location for such a facility. We are planning such a facility where.
Speaker Change: We are having additional indications such as the temperature stable formulation and additional indications that we're working on that this facility will need to support a so we have the funding for that.
Speaker Change: Hopefully by the end of this year, we know exactly what to easily acquired in order to finalize building such a facility I would expect it for a year.
Speaker Change: A year.
Speaker Change: It will not have any impact on our.
Speaker Change: Revenue guidance, because we are speaking now on 2027 2028.
Speaker Change: But we will have a lot of our additional capacity either to manufacture more S. Correct auto manufacturer the military use indication the etcetera. So it's a project.
Speaker Change: Important for us, but it won't have any impact on the next four years other than getting funding from the U S government.
Speaker Change: Okay. Thank you very much thanks for taking my questions. Thanks to think okay.
Speaker Change: And our next question today comes from James Knickerbocker with Craig Hallum. Please go ahead.
James Knickerbocker: Good morning, Thanks for taking my questions.
James Knickerbocker: Just a couple on the <unk> study around enrollment. So can you just kind of curious Dan on what Youre hearing from prospective centers as far as what they think enrollment rates that are feasible or.
James Knickerbocker: And then how are the early site activation activities going everything planned so far and then along those lines and with the LCD.
James Knickerbocker: There's a number of skinny sub trials going on as a result of the clinical evidence requirements in that LCD, we were referencing.
James Knickerbocker: Are you watching out for any competition for patients or kind of what are you hearing from new centers, sorry for the multi partner. Thanks.
James Knickerbocker: So a high chance that I hope I remember all the part of the question, let's start with the end because this is how I remember it works.
James Knickerbocker: We when we did the feasibility study.
James Knickerbocker: The ability to think about which sites to pick.
James Knickerbocker: We chose a site that do not have competing trials.
James Knickerbocker: And having said that we might have one try though to competing in specific sites, but.
James Knickerbocker: None of them can commit compete financially in our trial. We are much much complicated trial, we are paying much more money for each patient.
James Knickerbocker: Centered around $100000 per patient, which is at least.
James Knickerbocker: Three or four times more than delegating form simpler.
James Knickerbocker: I think the trials. So we do not identify as an issue. This is the first this is the last part of your question I saw the rates. We are aiming for the same rates that we had in the previous phase two chronic study, which is half a patient per center.
James Knickerbocker: Month, a very feasible. It is also based on the experience of the Seattle over the field working on in this phase III study and it looks something that all our calculations are based on these these numbers can be a little bit quicker, but as I said as I answered to I think al.
James Knickerbocker: Hey.
Speaker Change: I don't we are not pushing to you or not.
Speaker Change: We are focusing on the quality of the trial and not and trying to recruit as many patients as possible quicker because the patients out there.
Speaker Change: Did I Miss any part of the of the got it in place Yeah, Yeah, and then just kind of back on the on the site activation side.
Speaker Change: That was all very helpful and just on the site activation side as everything kind of happens to plan.
Speaker Change: Anything that's going better or anything that's taken a little bit longer I know it's early days.
Speaker Change: Yeah. Currently we were well prepared who will work with us to stop the study. So we have agreements in place and that the the sites.
Speaker Change: We're enthusiastic and we don't see any.
Speaker Change: Delays on the contrary we are again, we are we are we just started in the United States. So at least something like 50% of the sites open in the next couple of months, but we are in a very good place and in the United States. There is a lot of enthusiasm along do specific trial.
Speaker Change: Good and then just maybe one for for Honey.
Speaker Change: If we think about R&D spend this year is the be all you trial ramps up.
Speaker Change: Is that kind of per patient that they're enrolled the right kind of way for us to think about it and model R&D or are there other kind of start up expenses, we should be thinking about maybe just kind of any way you can help us think about R&D spend in 'twenty five thank you.
Speaker Change: Yeah, I think that in 2025, our R&D expenses will increase.
Speaker Change: Back to 2024 of call it derived from and it's also said the patient the cost will be around 100, K a U S. Dollar. So as we are aiming to enroll and around a 100 patient do you feel you can do the calculation and.
Speaker Change: The result is that we will now be a cost will increase substantially.
Speaker Change: Back to 2024.
Speaker Change: Very helpful. Thanks for the question.
Speaker Change: Thank you chase.
Speaker Change: Thank you and our next question comes from Michael which was Maxim Group. Please go ahead.
Speaker Change: Hey, guys. Thank you so much for taking my questions today, Congrats on all the good progress.
Speaker Change: Yep Yep.
Speaker Change: I guess first of all I would just like to ask a little bit about on the <unk>.
Speaker Change: <unk> study could you talk about the rationale for partnering with.
Speaker Change: Paris system.
Speaker Change: And does this replace the memetics grass or is it a different type of grass.
Speaker Change: So.
Speaker Change: The rationale is that we want to work with the best products and we don't want to be associated with this specific.
Speaker Change: That's one care company. So if you look at the city gate, the best data as far as we know and venous leg ulcers medics is and this is why we signed with them.
Speaker Change: Best without that we see in diabetic foot ulcers are of.
Speaker Change: Terrorists as Colloblast. This is why we pick them as you can imagine and based on the environment and the CPP and the LCD and the reimbursement that all of them are interested to participate.
Speaker Change: <unk> to generate more data and to be used by as many sites as possible. So we have the ability to choose and we are happy with those specific two partners to predict.
Speaker Change: Okay, and then let me look here 2025 revenue guidance could you help us understand where that $4 million in incremental growth comes from if we are expecting the MAA approval on that facility to come in early 'twenty six.
Speaker Change: Yeah, so as I'm, saying.
Speaker Change: We do not expect to sell more mix of blades units.
Speaker Change: Not substantial more mix of blades, you only see in 2020 five that a couple of two or three weeks more that we can manufacture due to all kinds of activation.
Speaker Change: The vision effort that we had last year. So we have a few more weeks of manufacturing and also we increased the price a little bit where we could and we are shifting territories are more profitable till it always so the numbers. According to the current to the current plan and the math shows that.
Speaker Change: The revenue will increase quite substantially but again it is still based on the same capacity, maybe another two or three weeks more and higher prices.
Speaker Change: Okay. Thank you very much for the additional color.
Speaker Change: Thank you.
Speaker Change: Thank you. This concludes our question and answer session I'd like to turn the conference back over to management for closing remarks.
Speaker Change: So thank you everyone for joining us today I'll enjoy it we look forward to continuing the dialogue and updating you on our progress during the next quarterly call.
Speaker Change: Bye.
Speaker Change: Thank you.
Speaker Change: This conference call. We thank you all for your participation and you may now disconnect your lines have a wonderful day.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: Uh huh.
Speaker Change: Uh-huh.
Speaker Change: Mhm.
Speaker Change: Hum.
Speaker Change: Uh huh.