NASDAQ:MDWD MediWound Q1 2024 Earnings Report $16.57 -0.70 (-4.05%) Closing price 05/8/2026 04:00 PM EasternExtended Trading$16.61 +0.04 (+0.27%) As of 05/8/2026 04:10 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. ProfileEarnings HistoryForecast MediWound EPS ResultsActual EPS-$0.39Consensus EPS -$0.40Beat/MissBeat by +$0.01One Year Ago EPSN/AMediWound Revenue ResultsActual Revenue$4.96 millionExpected Revenue$4.65 millionBeat/MissBeat by +$310.00 thousandYoY Revenue GrowthN/AMediWound Announcement DetailsQuarterQ1 2024Date5/29/2024TimeN/AConference Call DateMonday, June 3, 2024Conference Call Time10:34AM ETUpcoming EarningsMediWound's Q1 2026 earnings is estimated for Wednesday, May 20, 2026, based on past reporting schedulesConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Earnings HistoryCompany ProfilePowered by MediWound Q1 2024 Earnings Call TranscriptProvided by QuartrJune 3, 2024 ShareLink copied to clipboard.Key Takeaways The company reported Q1 2024 revenue of $5.0 million, up from $3.8 million a year ago, driven by accelerated NexoBrid sales and a new U.S. Department of Defense contract. Construction of a new GMP-compliant manufacturing facility remains on track for mid-2024 completion, with commissioning in Q3 and full operational capacity (6× current output) expected in 2025. The EscharEx Phase III trial for venous leg ulcers is set to start in H2 2024, enrolling 216 patients across 40 sites, under collaborations with Solventum, Moliki and MeMedics after final protocol submission. Proposed Medicare reimbursement changes are expected to favor biologics with robust clinical data, positioning EscharEx to capture market share by preparing wounds for tissue-based therapies. As of March 31, 2024, MediWound held $36 million in cash and equivalents, while net loss widened to $9.7 million (–$1.05 per share) due mainly to a $6.1 million warrant revaluation charge. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallMediWound Q1 202400:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Good day, and welcome to MediWound's First Quarter 2024 earnings call. Today's conference is being recorded. If you require operator assistance, please press Star then zero. At this time, I would like to turn the conference over to Dan Ferry of LifeSci Advisors. Please go ahead. Dan FerryManaging Director at LifeSci Advisors00:00:21Thank you, operator, and welcome everyone. Today, before the market open, MediWound issued a press release announcing financial results for the first quarter ended March 31, 2024. You may access that release on the company's website under the Investors tab. With us today, Ofer Gonen, Chief Executive Officer of MediWound, Hani Luxenburg, Chief Financial Officer, and Barry Wolfenson, Executive Vice President of Strategy and Corporate Development. Following our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session, relating to MediWound's expected future performance, future business prospects, or future events or plans, are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Dan FerryManaging Director at LifeSci Advisors00:01:09Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and the results are subject to risks and uncertainties that could differ materially from those forecasts due to the impact of many factors beyond the control of MediWound. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to cautionary notes set forth in today's press release, as well as the risk factors set forth in MediWound'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. The conference call is property of MediWound, and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. Dan FerryManaging Director at LifeSci Advisors00:01:56Now, I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound. Ofer? Ofer GonenCEO at MediWound00:02:04Thank you, Dan, and good morning, everyone. Welcome to MediWound's First Quarter 2024 earnings call. Joining me today are Hani Luxenburg, our Chief Financial Officer, and Barry Wolfenson, our Executive Vice President of Strategy and Corporate Development. After a presentation of the financial results and business updates, we will open the call for your questions. During the first quarter, we were laser-focused on executing our strategic plan. At the beginning of the year, we set three major goals. First, to accelerate NexoBrid revenue growth. Second, to complete the construction of our new manufacturing facility by mid-year. And third, initiate the EscharEx phase III clinical trial in the second half of 2024, for which we already established collaborations with the most prominent wound care companies. I'm pleased to report that we are on track to achieve all these targets. Ofer GonenCEO at MediWound00:03:10I'm also excited to announce that according to a preliminary list of additions posted on May 24, we are set to join the Russell 3000 Index as part of the 2024 Russell Indexes reconstitution. This inclusion will also grant us automatic membership in the small-cap Russell 2000 Index. Being included in these indexes is a significant milestone, enabling our visibility and reach within the investment community. Now, let's move for the first quarter highlights and recent developments. NexoBrid overview. This quarter has showcased significant achievements for NexoBrid, aligning with our strategic goals. We have secured orders that meet our annual revenue projection of $24 million, with $5 million realized this quarter. In the United States, our collaborations with Vericel has been very productive. Over 60 burn centers have submitted applications to their P&T committees. Ofer GonenCEO at MediWound00:04:21Approximately 40 have received approvals, and more than 30 centers have placed initial orders. Vericel has reported substantial increases in both the number of patients treated with NexoBrid and the number of orders from burn centers and hospitals. Internationally, the adoption of NexoBrid in Europe, Japan, and India, through our partnerships with PolyMedics, Kaken Pharmaceuticals, and BSV, continue to show promising growth. These markets are instrumental in driving broader interest and use of NexoBrid. Additionally, we have seen a continued increase in demand for NexoBrid in treating military casualties due to the ongoing war in Israel. Dozens of lives of soldiers and civilians were saved. The positive outcome achieved with NexoBrid have generated interest from many governments for future stockpiling. To meet this surging demand, we are actively enhancing our manufacturing infrastructure. Ofer GonenCEO at MediWound00:05:30Construction of our new GMP compliant state-of-the-art facility is progressing on schedule to be completed by mid-2024, with commissioning set to begin in the third quarter of this year. The facility is expected to be fully operational in 2025, increasing our manufacturing capacity sixfold. Regarding additional growth drivers, the FDA has accepted our supplemental BLA for pediatric use, with the decision expected in the second half of this year. It is worth noting that NexoBrid is already approved for pediatric population in Europe and in Japan. Our partnership with the U.S. Army is advancing as planned, focusing on the development of temperature-stable formulation for NexoBrid. We anticipate FDA's feedback on the product development path in the second half of this year. This project, bolstered by a $13 million grant from the Department of Defense, underscores the strategic importance of NexoBrid in field care burn treatments. Ofer GonenCEO at MediWound00:06:45Lastly, we continue to generate further data to support NexoBrid use. Our expanded access treatment protocol has successfully treated 239 burn patients across 29 U.S. sites. With enrollment and 12-month follow-up now complete, we are ready to begin data analysis, with findings to be published in the second half of 2024. Overall, the increasing global demand and our strategic expansion of the manufacturing capabilities, along with the broadening scope of indications, position NexoBrid to establish a new standard of care in eschar removal for severe burns. We are very pleased with NexoBrid's performance and the ongoing progress in all those areas. Now I'll provide an update on EscharEx, our innovative bioactive therapy for venous leg ulcers and other chronic wounds. Ofer GonenCEO at MediWound00:07:48We have successfully manufactured the clinical batches and are on schedule to submit the final protocol for our phase III trial in the first half of 2024. The trial is set to commence in the second half of this year. The phase III study, mirroring the successful design of our phase II trials, will be structured as a multicenter, prospective, randomized, and placebo-controlled global trial. We aim to enroll 216 patients across 40 sites, focusing on two co-primary endpoints: the incidence of complete debridement and the incidence of wound closure. An interim assessment will be conducted after 67% of the participants complete the trial, providing early insights into the efficacy of EscharEx. Ofer GonenCEO at MediWound00:08:41This study has garnered significant interest from prominent companies in the wound care space, resulting in established research collaborations with Solventum, Mölnlycke, and MIMEDX, leaders in compression therapy, advanced wound care settings, and dressings, I'm sorry, and tissue-based products. EscharEx has also attracted a lot of attention at three major annual wound care conferences: the Wound Healing Society, the Symposium on Advanced Wound Care, and the European Wound Management Association. Strong phase II data was presented demonstrating EscharEx's superiority over SANTYL, the current market leader, with more than $360 million in annual US sales. Recently, there has been a significant discussion about the proposed changes in Medicare reimbursement for cell and tissue-based products. If implemented, these changes will have major impact on the wound care industry and will greatly benefit EscharEx. We are not surprised by these changes. Ofer GonenCEO at MediWound00:09:53We anticipate that the market share will shift from smaller companies without strong clinical evidence to larger, established companies. Additionally, one of the key changes is to limit the number of tissue units that can be applied to a wound, requiring more attention to the condition of the wound bed prior to initiating tissue applications. EscharEx excels in this area. It is not just debridement, but it also quickly prepare the wounds for application of tissue. Our ongoing phase III study is perfectly aligned with this, as we aim to secure a claim for preparing a wound for active closure. Generally, as the market value of tissue therapies decreases, the relative value of biologic drugs with a blockbuster potential will increase. Ofer GonenCEO at MediWound00:10:54EscharEx, going through a rigorous BLA process, backed by extensive and robust trial data and entering into a category that has just stable reimbursement for decades, become an even more valuable asset when these policies become effective. In conclusion, EscharEx is poised to become a leader in the biologic sector of the advanced wound care market. Our data to date showcases its superior efficacy in debridement, wound closure preparation, time to wound healing, biofilm removal, and bacterial reduction, highlighting its versatility and utility. The comprehensive clinical and health economic data that we are generating in the phase III study will further solidify EscharEx's strong position within the industry. Now, I'll hand it over to Hani to briefly review our financials. Hani? Hani LuxenburgCFO at MediWound00:11:59Thank you, Ofer. Let me begin with our revenue for the first quarter. Revenue for the first quarter of 2024 was $5 million, compared to $3.8 million in the first quarter of 2023....The increase is primarily attributed to revenue from Vericel, a new contract with the U.S. Department of Defense. Gross profit in the first quarter of 2024 was $0.6 million, representing 12.2% of total revenue, compared to $0.8 million, representing 21.7% of total revenue in the same quarter in the previous year. The decrease in gross profit is primarily due to changes in the revenue mix. Turning to our operating expenses. R&D expenses in the first quarter of 2024 were $1.5 million, compared to $2.1 million in the first quarter of 2023. Hani LuxenburgCFO at MediWound00:13:05This decrease is primarily due to the completion of EscharEx phase II study. SG&A expenses in the first quarter of 2024 were $2.9 million, compared to $3.1 million in the first quarter of last year. Operating loss in the first quarter of 2024 was $3.7 million, compared to an operating loss of $4.4 million in the first quarter of 2023. Net loss in the first quarter of 2024 was $9.7 million, or $1.05 per share, compared to a net loss of $3.7 million, or $0.44 per share in the first quarter of 2023. The increase in net loss is primarily due to financial expenses from revaluation of warrants, amounting to $6.1 million, driven by 40% increase in our share price. Hani LuxenburgCFO at MediWound00:14:12Non-GAAP adjusted EBITDA for the first quarter of 2024 was a loss of $2.9 million, compared to a loss of $3.4 million in the first quarter of 2023. Balance sheet highlights. As of March 31, 2024, the company had cash and cash equivalent, restricted cash and deposit totaling $36 million, compared to $42.1 million as of December 31, 2023. During the first quarter of 2024, the company received $500,000 from exercise of warrants. The company utilized $6.5 million to fund its activity, of which $2.7 million was invested in CapEx related to facility scale-up. This conclude the financial review. I will now turn the call back to Ofer. Ofer? Ofer GonenCEO at MediWound00:15:15Thank you, Hani. This past quarter, we demonstrated operational excellence, achieving $5 million in revenues from NexoBrid and progressing towards the completion of our manufacturing facility. This expansion will enable us to effectively meet both current and anticipated demand for NexoBrid. Regarding EscharEx, which targets a highly lucrative $2 billion market, we remain on track to initiate the phase III trial in the second half of this year. We look forward to working closely with Solventum, Mölnlycke, and MIMEDX, who are supporting this trial. Their collaboration sets the stage for a successful and reputable phase III study, ensuring best treatment options are available for patients. With these highlights shared, I'd like to turn back to the operator for any questions you may have. Operator? Operator00:16:13We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are 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. At this time, we will pause momentarily to assemble our roster. The first question comes from Josh Jennings with TD Cowen. Please go ahead. Josh JenningsManaging Direcotr and Senior Research Analyst at TD Cowen00:16:52Hi, thanks so much for taking the questions, and congratulations on the continued progress. Ofer, I was hoping just to ask two manufacturing questions, relatively high level, maybe you'd share some more detail. First, on the build-out of manufacturing capacity for NexoBrid. So what are the remaining steps left to complete that project? And should we be thinking about that plant, that facility, ramping up and being cleared and ready to go early in 2025, or could that be sometime closer to midyear? Ofer GonenCEO at MediWound00:17:35Thank you for your question, Josh. I would like to address this point. So, as for the facility, we guided that we are about to complete the manufacturing in mid-2024. It means that all the equipment is here, and it was not a trivial assignment. So all the equipment is here. It is now we are in the final stages of installing it, and once it's done, and we expect it, it will be done in the middle of the year, which means in the next few weeks, we will start the commissioning process, which means all kind of validation activities, et cetera. After that, it will take a few months. We are submitting the facility for approval by EMA and FDA. Ofer GonenCEO at MediWound00:18:24We do not expect both of them to approve the facility in the same time. We expect that the European authorities will be quicker, which means that I don't have an answer when it will be fully operational. If it will be in the beginning of 25 or in the middle of 25 or even in the third quarter of 25, I think it will be gradual, with the European agency approving it much quicker. And when it is done, we have our capacity, you know, our, our major bottleneck will be resolved because we can start immediately manufacture to the European market from the new facility. So in 2025, we will be in a position, definitely towards the end of it, that we have almost no limitations. Josh JenningsManaging Direcotr and Senior Research Analyst at TD Cowen00:19:14Excellent. That's helpful. And then just on the last earnings call, you mentioned that there was some initial manufacturing of EscharEx batches for the clinical trial and some stability testing being performed. Hoping to just get an update on where MediWound stands in terms of EscharEx production or manufacturing for the clinical trial. And if you can just remind us about the formulation, any differences in manufacturing between EscharEx and NexoBrid? And has everything progressed, and sounds like it has, 'cause you've given timelines about starting this trial, getting the trial approved and ready to roll by mid-year. Thanks a lot. Ofer GonenCEO at MediWound00:19:57Yeah. So, let me elaborate on this aspect. The manufacturing of EscharEx and NexoBrid are not being done in the same suites. It's a different suite of manufacturing. The process of having our clearance from the FDA to start the trial is manufacturing the clinical batches, which was done in Q1. After that, there is a stability time period, which is around 30 days. We do not anticipate any issues with that because we've manufactured many, many EscharEx batches for previous trials or for all kind of preclinical studies. Ofer GonenCEO at MediWound00:20:46Immediately after that, as we guided, which means in the middle of this year or in the first half of this year, which is almost the same, we will be able to submit the final protocol to the FDA with all the data regarding the batches that were manufactured. After that, when we get the clearance, it should be something like after 30 days, 60 days, we will be ready to roll. Josh JenningsManaging Direcotr and Senior Research Analyst at TD Cowen00:21:14Excellent. Thanks for reviewing that. Appreciate it. Operator00:21:19The next question comes from François Brisebois with Oppenheimer. Please go ahead. François BriseboisManaging Director and Senior Analyst at Oppenheimer00:21:26Hi, thanks for the question. Just to follow up on the previous one, in terms of being fully operational in 25, that sixfold capacity, so that's the part that might be gradual. Is it fair to assume that, the sixfold will be, you know, gradual to, to get there? And can you just elaborate a little bit on where demand is currently versus capacity? Ofer GonenCEO at MediWound00:21:51Hi, Frank, and thank you for the question. It's an important topic. So currently, the demand is the same as we mentioned last quarter. It is approximately threefold in our ability to manufacture. So if you need to anticipate what's the step up in our manufacturing capabilities, I would assume—currently, let's assume it's a 1x. After we get the European approval, it becomes 2x, because we can manufacture everything, I mean, everything for Europe in the new manufacturing facility. Still, the manufacturing capabilities for the United States and from Japan, which are very significant markets, still will be done in the previous manufacturing facility until we get the approval from the FDA. Ofer GonenCEO at MediWound00:22:45But the bottleneck now that makes us juggle between all kind of customers and patients that need a solution, we believe the main bottleneck will be removed in the beginning of 2025. François BriseboisManaging Director and Senior Analyst at Oppenheimer00:23:01Understood. And then in terms of the interim analysis, can you help us understand the implications there, what that means? Is there a chance that the interim analysis would, you know, with overwhelming efficacy, would just end the trial? Or just what are the different scenarios from this interim analysis? Ofer GonenCEO at MediWound00:23:20Yeah, thank you for the question. So, the interim analysis will not stop the trial. A phase III study for such a huge indication, we're speaking about 1 million patients annually in the United States. A phase III study with 216 patients is considered very small. I do not anticipate FDA to approve a drug based on a phase III study with only 140 patients. The reason that we are doing an interim assessment, it's just an assessment for the sample size. If we see currently the trial is planned with for 90% power for succeeding in the trial, in both primary endpoints. Ofer GonenCEO at MediWound00:24:14We want to make sure that after 140 patients, we are on track to achieve that. If we need to increase the number by, I don't know, 20 patients, 30 patients, to be sure that we are going to succeed in the trial, it will be done. Most probably, that after the interim analysis, we will continue the trial as planned without changing anything. François BriseboisManaging Director and Senior Analyst at Oppenheimer00:24:38Thank you. Operator00:24:41The next question comes from RK at H.C. Wainwright. Please go ahead. Swayampakula RamakanthManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:24:48Good morning, Ofer. How are you doing? Thanks for taking my questions. You know, in your prepared remarks, you said you have secured orders for $24 million from Vericel. Do they have a minimum every year or how are these orders set up? Ofer GonenCEO at MediWound00:25:16Well, I didn't say that we secured $24 million from Vericel. We said we secured $24 million for the year 2024. Vericel is only one of our revenue channels. So we have an agreement with Vericel. They'll tell us, they tell us in advance, how much they anticipate for the year. We didn't disclose the number, and they are getting it, as they request. So for 2024, for instance, we already got the binding order for Vericel. Some of it was already shipped to them, and some of it is being manufactured. Swayampakula RamakanthManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:25:58Thank you for that. And then, in terms of the next data that you're planning to publish, so would we see that, would we see some of that, you know, this year, or do you expect it next year? And how is that going to help, you know, in reimbursement and also in your conversations with private payers? Ofer GonenCEO at MediWound00:26:33Are you speaking about NexoBrid? Swayampakula RamakanthManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:26:35Yeah. Ofer GonenCEO at MediWound00:26:37Okay, so, don't hold your breath. We are going to the 239 patient data that we are about to share the data by the, in the second half of the year, are patients that are treated in real life. I wouldn't expect something different than what we saw in the phase III study. The efficacy of NexoBrid is so robust. You saw it in the trial, 93% versus, I don't know, 4%. The, so it will be very robust. I do not expect anything different than with what we saw. Ofer GonenCEO at MediWound00:27:22As for the impact on the reimbursement, Vericel is doing a great job in having this treatment approved by P&T committees in hospitals in a specific price, and I think it won't make a change at all. Swayampakula RamakanthManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:27:41Okay. And then, in terms of EscharEx, now that you have all your material ready for the start of the study, is there any other approvals or conversations needed between you and the FDA before you start the study? Or is it just IRB approvals that you're waiting for to get the study going? Ofer GonenCEO at MediWound00:28:12So the process is quite clear. Since we manufactured the clinical batches and waiting for stability, it's only 30 days. Let's assume it will be done in the next couple of weeks. After that, we submit a protocol that we already got a guidance and approval from EMA and FDA. We'll submit the protocols, and unless they see something which is which is very different than what we agreed on, we will get a clearance or no objections in the next the 30-day following following the submission. After that, the IRBs is also something technical. I wouldn't expect the... We do not expect any delay in our guidance of initiating the trial in the second half of this year. Swayampakula RamakanthManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:29:00Okay, thank you very much. Thanks for taking all my questions. Ofer GonenCEO at MediWound00:29:03Thank you, RK. Operator00:29:07The next question comes from Michael Okunewitch with Maxim Group. Please go ahead. Michael OkunewitchSenior Analyst at Maxim Group00:29:19Hey, guys. Thank you so much for taking my questions today. Ofer GonenCEO at MediWound00:29:24Hi, Michael. Michael OkunewitchSenior Analyst at Maxim Group00:29:24So, I guess first off, just to talk about the Medicare changes that you mentioned earlier. In the phase III, will you be looking at the difference in the number of required tissue applications just to potentially have data addressing those claims directly? Ofer GonenCEO at MediWound00:29:45Well, it's a great question. Barry, can you please address it? Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:29:51Certainly we will, you know, be capturing. We're not gonna change the protocol of our study in anticipation of any changes that are being made in Medicare. But we will absolutely capture the data in hopes that it's reflective of, you know, where those changes land. I think, you know, one of the benefits that, that obviously in, in the study is that we get this head start. And so, as the wounds get to be completely debrided and completely covered with granulation tissue, we get to start with active closure sooner, and it stands to bear, given the data that already exists in the published literature, that there's gonna be more that close in our arm and close with these limited number of tissues, and four, than there would be in the control arm. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:30:49So either way, we stand to benefit. Michael OkunewitchSenior Analyst at Maxim Group00:30:53All right. Thank you. And then, with regards to the phase III, now that, you know, you're getting pretty close to getting that started, do you have any updated expectations regarding the enrollment rate and the time to that interim data? Ofer GonenCEO at MediWound00:31:10So, with the low number of patients that we anticipate to recruit, the 216 patients, and also we have limited competition. Look at clinicaltrials.gov, you will not find a clinical trial with VLU patients. We are confident for a very quick patient enrollment. It should take us after six months of a start-up period, it will take us additional 18 months to finish and execute the protocol. Michael OkunewitchSenior Analyst at Maxim Group00:31:45All right. Thank you very much. And then just one last one from me. Ofer GonenCEO at MediWound00:31:48Thank you. Michael OkunewitchSenior Analyst at Maxim Group00:31:48Just a point of clarification. Have you met with the FDA on the temperature-stable DoD formulation and are waiting for feedback, or are you still expecting to meet with them in the next couple weeks? Ofer GonenCEO at MediWound00:32:06This is a great question. So, as I told earlier, we got quite a significant funding from the DoD to develop this temperature-stable formulation. We already approached the FDA regarding the product development path, and we are anticipating the feedback, which will be in the second half of 2024. Michael OkunewitchSenior Analyst at Maxim Group00:32:34Thank you very much. Ofer GonenCEO at MediWound00:32:36Thank you. Operator00:32:40This concludes our Q&A session. I would like to turn the call back over to Ofer Gonen for closing remarks. Ofer GonenCEO at MediWound00:32:51Thank you everyone for joining us today. We look forward to updating you again in our next quarterly call. Operator00:32:59The conference has concluded. Thank you for attending today's presentation. You may now disconnect.Read moreParticipantsExecutivesBarry WolfensonEVP of Strategy and Corporate DevelopmentHani LuxenburgCFOOfer GonenCEOAnalystsDan FerryManaging Director at LifeSci AdvisorsFrançois BriseboisManaging Director and Senior Analyst at OppenheimerJosh JenningsManaging Direcotr and Senior Research Analyst at TD CowenMichael OkunewitchSenior Analyst at Maxim GroupSwayampakula RamakanthManaging Director and Senior Healthcare Analyst at H.C. WainwrightPowered by Earnings DocumentsPress Release(8-K) MediWound Earnings HeadlinesMediWound to Report First Quarter 2026 Financial ResultsMay 7 at 8:00 AM | globenewswire.comMediWound Shareholders Back Board, Auditor and CEO Bonus at 2026 Annual MeetingMay 6 at 4:51 PM | tipranks.com$30 stock to buy before Starlink goes public (WATCH NOW!)A little-known stock pick with money-doubling potential over the next year is revealed for free in the first three minutes of a new video. This company is a critical piece of Elon Musk's fast-growing Starlink technology. It could climb 100 percent or more over the next year as Elon brings Starlink public in what may be the biggest IPO in history. No credit card is required to get the ticker. | Paradigm Press (Ad)Analysts Offer Insights on Healthcare Companies: Simulations Plus (SLP) and Mediwound (MDWD)April 16, 2026 | theglobeandmail.comNewly Published U.S. Expert Consensus Aligns with MediWound’s Strategy for Chronic Wound DebridementApril 13, 2026 | markets.businessinsider.comNewly Published U.S. Expert Consensus Aligns with MediWound's Strategy for Chronic Wound DebridementApril 13, 2026 | globenewswire.comSee More MediWound Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like MediWound? Sign up for Earnings360's daily newsletter to receive timely earnings updates on MediWound and other key companies, straight to your email. Email Address About MediWoundMediWound (NASDAQ:MDWD) (NASDAQ: MDWD) is a biopharmaceutical company headquartered in Yavne, Israel, specializing in the development and commercialization of innovative enzymatic therapies for burn and wound management. Since its establishment, the company has focused on advancing proteolytic enzyme technology to address critical needs in debridement and tissue repair. MediWound operates research and development facilities in Israel and maintains commercial offices in the United States to support its global market presence. The company’s lead product, NexoBrid®, is an enzyme-based debriding agent designed to selectively remove burn eschar without harming viable tissue. NexoBrid has received regulatory approval in the European Union and by the U.S. Food and Drug Administration for use in adults with severe thermal burns. MediWound is also advancing EscharEx™, a topical therapy aimed at debriding chronic and hard-to-heal wounds, currently undergoing pivotal clinical trials to expand its therapeutic portfolio. MediWound’s commercial reach spans North America, Europe and other international markets through a network of strategic distribution partners. In the United States, the company supports its sales efforts with a dedicated subsidiary and field-based clinical specialists, while in Europe it works with established distributors to ensure product availability and regulatory compliance. The company continues to explore additional indications and territories to broaden access to its enzymatic treatments. Leadership at MediWound is spearheaded by Chief Executive Officer Dan Rosenwasser, who has guided the company’s strategic expansion and commercialization initiatives. Under his direction, MediWound has strengthened its manufacturing capabilities and fortified its clinical pipeline. The management team’s combined expertise in biotechnology, regulatory affairs and commercial operations underpins the company’s mission to deliver advanced wound care solutions to patients worldwide.View MediWound ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles Rocket Lab Posts Record Q1 Revenue, Raises Q2 GuidanceHims & Hers Earnings Preview: The Novo Nordisk Shift Puts GLP-1 Strategy in FocusAppLovin Pops After Earnings With Growth Catalysts in SightDutch Bros Q1 Earnings: The Newest Starbucks Rival Faces Its First Big Reality CheckThe AI Fear Around Datadog Stock May Have Been Completely WrongAmprius Technologies Ups the Voltage on Forward OutlookWhy Lam Research Still Looks Like a Buy After a 300% Rally Upcoming Earnings Constellation Energy (5/11/2026)Barrick Mining (5/11/2026)Petroleo Brasileiro S.A.- Petrobras (5/11/2026)Simon Property Group (5/11/2026)SEA (5/12/2026)Cisco Systems (5/13/2026)Alibaba Group (5/13/2026)Manulife Financial (5/13/2026)Sumitomo Mitsui Financial Group (5/13/2026)Takeda Pharmaceutical (5/13/2026) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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PresentationSkip to Participants Operator00:00:00Good day, and welcome to MediWound's First Quarter 2024 earnings call. Today's conference is being recorded. If you require operator assistance, please press Star then zero. At this time, I would like to turn the conference over to Dan Ferry of LifeSci Advisors. Please go ahead. Dan FerryManaging Director at LifeSci Advisors00:00:21Thank you, operator, and welcome everyone. Today, before the market open, MediWound issued a press release announcing financial results for the first quarter ended March 31, 2024. You may access that release on the company's website under the Investors tab. With us today, Ofer Gonen, Chief Executive Officer of MediWound, Hani Luxenburg, Chief Financial Officer, and Barry Wolfenson, Executive Vice President of Strategy and Corporate Development. Following our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session, relating to MediWound's expected future performance, future business prospects, or future events or plans, are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Dan FerryManaging Director at LifeSci Advisors00:01:09Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, actual outcomes and the results are subject to risks and uncertainties that could differ materially from those forecasts due to the impact of many factors beyond the control of MediWound. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to cautionary notes set forth in today's press release, as well as the risk factors set forth in MediWound'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. The conference call is property of MediWound, and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. Dan FerryManaging Director at LifeSci Advisors00:01:56Now, I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound. Ofer? Ofer GonenCEO at MediWound00:02:04Thank you, Dan, and good morning, everyone. Welcome to MediWound's First Quarter 2024 earnings call. Joining me today are Hani Luxenburg, our Chief Financial Officer, and Barry Wolfenson, our Executive Vice President of Strategy and Corporate Development. After a presentation of the financial results and business updates, we will open the call for your questions. During the first quarter, we were laser-focused on executing our strategic plan. At the beginning of the year, we set three major goals. First, to accelerate NexoBrid revenue growth. Second, to complete the construction of our new manufacturing facility by mid-year. And third, initiate the EscharEx phase III clinical trial in the second half of 2024, for which we already established collaborations with the most prominent wound care companies. I'm pleased to report that we are on track to achieve all these targets. Ofer GonenCEO at MediWound00:03:10I'm also excited to announce that according to a preliminary list of additions posted on May 24, we are set to join the Russell 3000 Index as part of the 2024 Russell Indexes reconstitution. This inclusion will also grant us automatic membership in the small-cap Russell 2000 Index. Being included in these indexes is a significant milestone, enabling our visibility and reach within the investment community. Now, let's move for the first quarter highlights and recent developments. NexoBrid overview. This quarter has showcased significant achievements for NexoBrid, aligning with our strategic goals. We have secured orders that meet our annual revenue projection of $24 million, with $5 million realized this quarter. In the United States, our collaborations with Vericel has been very productive. Over 60 burn centers have submitted applications to their P&T committees. Ofer GonenCEO at MediWound00:04:21Approximately 40 have received approvals, and more than 30 centers have placed initial orders. Vericel has reported substantial increases in both the number of patients treated with NexoBrid and the number of orders from burn centers and hospitals. Internationally, the adoption of NexoBrid in Europe, Japan, and India, through our partnerships with PolyMedics, Kaken Pharmaceuticals, and BSV, continue to show promising growth. These markets are instrumental in driving broader interest and use of NexoBrid. Additionally, we have seen a continued increase in demand for NexoBrid in treating military casualties due to the ongoing war in Israel. Dozens of lives of soldiers and civilians were saved. The positive outcome achieved with NexoBrid have generated interest from many governments for future stockpiling. To meet this surging demand, we are actively enhancing our manufacturing infrastructure. Ofer GonenCEO at MediWound00:05:30Construction of our new GMP compliant state-of-the-art facility is progressing on schedule to be completed by mid-2024, with commissioning set to begin in the third quarter of this year. The facility is expected to be fully operational in 2025, increasing our manufacturing capacity sixfold. Regarding additional growth drivers, the FDA has accepted our supplemental BLA for pediatric use, with the decision expected in the second half of this year. It is worth noting that NexoBrid is already approved for pediatric population in Europe and in Japan. Our partnership with the U.S. Army is advancing as planned, focusing on the development of temperature-stable formulation for NexoBrid. We anticipate FDA's feedback on the product development path in the second half of this year. This project, bolstered by a $13 million grant from the Department of Defense, underscores the strategic importance of NexoBrid in field care burn treatments. Ofer GonenCEO at MediWound00:06:45Lastly, we continue to generate further data to support NexoBrid use. Our expanded access treatment protocol has successfully treated 239 burn patients across 29 U.S. sites. With enrollment and 12-month follow-up now complete, we are ready to begin data analysis, with findings to be published in the second half of 2024. Overall, the increasing global demand and our strategic expansion of the manufacturing capabilities, along with the broadening scope of indications, position NexoBrid to establish a new standard of care in eschar removal for severe burns. We are very pleased with NexoBrid's performance and the ongoing progress in all those areas. Now I'll provide an update on EscharEx, our innovative bioactive therapy for venous leg ulcers and other chronic wounds. Ofer GonenCEO at MediWound00:07:48We have successfully manufactured the clinical batches and are on schedule to submit the final protocol for our phase III trial in the first half of 2024. The trial is set to commence in the second half of this year. The phase III study, mirroring the successful design of our phase II trials, will be structured as a multicenter, prospective, randomized, and placebo-controlled global trial. We aim to enroll 216 patients across 40 sites, focusing on two co-primary endpoints: the incidence of complete debridement and the incidence of wound closure. An interim assessment will be conducted after 67% of the participants complete the trial, providing early insights into the efficacy of EscharEx. Ofer GonenCEO at MediWound00:08:41This study has garnered significant interest from prominent companies in the wound care space, resulting in established research collaborations with Solventum, Mölnlycke, and MIMEDX, leaders in compression therapy, advanced wound care settings, and dressings, I'm sorry, and tissue-based products. EscharEx has also attracted a lot of attention at three major annual wound care conferences: the Wound Healing Society, the Symposium on Advanced Wound Care, and the European Wound Management Association. Strong phase II data was presented demonstrating EscharEx's superiority over SANTYL, the current market leader, with more than $360 million in annual US sales. Recently, there has been a significant discussion about the proposed changes in Medicare reimbursement for cell and tissue-based products. If implemented, these changes will have major impact on the wound care industry and will greatly benefit EscharEx. We are not surprised by these changes. Ofer GonenCEO at MediWound00:09:53We anticipate that the market share will shift from smaller companies without strong clinical evidence to larger, established companies. Additionally, one of the key changes is to limit the number of tissue units that can be applied to a wound, requiring more attention to the condition of the wound bed prior to initiating tissue applications. EscharEx excels in this area. It is not just debridement, but it also quickly prepare the wounds for application of tissue. Our ongoing phase III study is perfectly aligned with this, as we aim to secure a claim for preparing a wound for active closure. Generally, as the market value of tissue therapies decreases, the relative value of biologic drugs with a blockbuster potential will increase. Ofer GonenCEO at MediWound00:10:54EscharEx, going through a rigorous BLA process, backed by extensive and robust trial data and entering into a category that has just stable reimbursement for decades, become an even more valuable asset when these policies become effective. In conclusion, EscharEx is poised to become a leader in the biologic sector of the advanced wound care market. Our data to date showcases its superior efficacy in debridement, wound closure preparation, time to wound healing, biofilm removal, and bacterial reduction, highlighting its versatility and utility. The comprehensive clinical and health economic data that we are generating in the phase III study will further solidify EscharEx's strong position within the industry. Now, I'll hand it over to Hani to briefly review our financials. Hani? Hani LuxenburgCFO at MediWound00:11:59Thank you, Ofer. Let me begin with our revenue for the first quarter. Revenue for the first quarter of 2024 was $5 million, compared to $3.8 million in the first quarter of 2023....The increase is primarily attributed to revenue from Vericel, a new contract with the U.S. Department of Defense. Gross profit in the first quarter of 2024 was $0.6 million, representing 12.2% of total revenue, compared to $0.8 million, representing 21.7% of total revenue in the same quarter in the previous year. The decrease in gross profit is primarily due to changes in the revenue mix. Turning to our operating expenses. R&D expenses in the first quarter of 2024 were $1.5 million, compared to $2.1 million in the first quarter of 2023. Hani LuxenburgCFO at MediWound00:13:05This decrease is primarily due to the completion of EscharEx phase II study. SG&A expenses in the first quarter of 2024 were $2.9 million, compared to $3.1 million in the first quarter of last year. Operating loss in the first quarter of 2024 was $3.7 million, compared to an operating loss of $4.4 million in the first quarter of 2023. Net loss in the first quarter of 2024 was $9.7 million, or $1.05 per share, compared to a net loss of $3.7 million, or $0.44 per share in the first quarter of 2023. The increase in net loss is primarily due to financial expenses from revaluation of warrants, amounting to $6.1 million, driven by 40% increase in our share price. Hani LuxenburgCFO at MediWound00:14:12Non-GAAP adjusted EBITDA for the first quarter of 2024 was a loss of $2.9 million, compared to a loss of $3.4 million in the first quarter of 2023. Balance sheet highlights. As of March 31, 2024, the company had cash and cash equivalent, restricted cash and deposit totaling $36 million, compared to $42.1 million as of December 31, 2023. During the first quarter of 2024, the company received $500,000 from exercise of warrants. The company utilized $6.5 million to fund its activity, of which $2.7 million was invested in CapEx related to facility scale-up. This conclude the financial review. I will now turn the call back to Ofer. Ofer? Ofer GonenCEO at MediWound00:15:15Thank you, Hani. This past quarter, we demonstrated operational excellence, achieving $5 million in revenues from NexoBrid and progressing towards the completion of our manufacturing facility. This expansion will enable us to effectively meet both current and anticipated demand for NexoBrid. Regarding EscharEx, which targets a highly lucrative $2 billion market, we remain on track to initiate the phase III trial in the second half of this year. We look forward to working closely with Solventum, Mölnlycke, and MIMEDX, who are supporting this trial. Their collaboration sets the stage for a successful and reputable phase III study, ensuring best treatment options are available for patients. With these highlights shared, I'd like to turn back to the operator for any questions you may have. Operator? Operator00:16:13We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are 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. At this time, we will pause momentarily to assemble our roster. The first question comes from Josh Jennings with TD Cowen. Please go ahead. Josh JenningsManaging Direcotr and Senior Research Analyst at TD Cowen00:16:52Hi, thanks so much for taking the questions, and congratulations on the continued progress. Ofer, I was hoping just to ask two manufacturing questions, relatively high level, maybe you'd share some more detail. First, on the build-out of manufacturing capacity for NexoBrid. So what are the remaining steps left to complete that project? And should we be thinking about that plant, that facility, ramping up and being cleared and ready to go early in 2025, or could that be sometime closer to midyear? Ofer GonenCEO at MediWound00:17:35Thank you for your question, Josh. I would like to address this point. So, as for the facility, we guided that we are about to complete the manufacturing in mid-2024. It means that all the equipment is here, and it was not a trivial assignment. So all the equipment is here. It is now we are in the final stages of installing it, and once it's done, and we expect it, it will be done in the middle of the year, which means in the next few weeks, we will start the commissioning process, which means all kind of validation activities, et cetera. After that, it will take a few months. We are submitting the facility for approval by EMA and FDA. Ofer GonenCEO at MediWound00:18:24We do not expect both of them to approve the facility in the same time. We expect that the European authorities will be quicker, which means that I don't have an answer when it will be fully operational. If it will be in the beginning of 25 or in the middle of 25 or even in the third quarter of 25, I think it will be gradual, with the European agency approving it much quicker. And when it is done, we have our capacity, you know, our, our major bottleneck will be resolved because we can start immediately manufacture to the European market from the new facility. So in 2025, we will be in a position, definitely towards the end of it, that we have almost no limitations. Josh JenningsManaging Direcotr and Senior Research Analyst at TD Cowen00:19:14Excellent. That's helpful. And then just on the last earnings call, you mentioned that there was some initial manufacturing of EscharEx batches for the clinical trial and some stability testing being performed. Hoping to just get an update on where MediWound stands in terms of EscharEx production or manufacturing for the clinical trial. And if you can just remind us about the formulation, any differences in manufacturing between EscharEx and NexoBrid? And has everything progressed, and sounds like it has, 'cause you've given timelines about starting this trial, getting the trial approved and ready to roll by mid-year. Thanks a lot. Ofer GonenCEO at MediWound00:19:57Yeah. So, let me elaborate on this aspect. The manufacturing of EscharEx and NexoBrid are not being done in the same suites. It's a different suite of manufacturing. The process of having our clearance from the FDA to start the trial is manufacturing the clinical batches, which was done in Q1. After that, there is a stability time period, which is around 30 days. We do not anticipate any issues with that because we've manufactured many, many EscharEx batches for previous trials or for all kind of preclinical studies. Ofer GonenCEO at MediWound00:20:46Immediately after that, as we guided, which means in the middle of this year or in the first half of this year, which is almost the same, we will be able to submit the final protocol to the FDA with all the data regarding the batches that were manufactured. After that, when we get the clearance, it should be something like after 30 days, 60 days, we will be ready to roll. Josh JenningsManaging Direcotr and Senior Research Analyst at TD Cowen00:21:14Excellent. Thanks for reviewing that. Appreciate it. Operator00:21:19The next question comes from François Brisebois with Oppenheimer. Please go ahead. François BriseboisManaging Director and Senior Analyst at Oppenheimer00:21:26Hi, thanks for the question. Just to follow up on the previous one, in terms of being fully operational in 25, that sixfold capacity, so that's the part that might be gradual. Is it fair to assume that, the sixfold will be, you know, gradual to, to get there? And can you just elaborate a little bit on where demand is currently versus capacity? Ofer GonenCEO at MediWound00:21:51Hi, Frank, and thank you for the question. It's an important topic. So currently, the demand is the same as we mentioned last quarter. It is approximately threefold in our ability to manufacture. So if you need to anticipate what's the step up in our manufacturing capabilities, I would assume—currently, let's assume it's a 1x. After we get the European approval, it becomes 2x, because we can manufacture everything, I mean, everything for Europe in the new manufacturing facility. Still, the manufacturing capabilities for the United States and from Japan, which are very significant markets, still will be done in the previous manufacturing facility until we get the approval from the FDA. Ofer GonenCEO at MediWound00:22:45But the bottleneck now that makes us juggle between all kind of customers and patients that need a solution, we believe the main bottleneck will be removed in the beginning of 2025. François BriseboisManaging Director and Senior Analyst at Oppenheimer00:23:01Understood. And then in terms of the interim analysis, can you help us understand the implications there, what that means? Is there a chance that the interim analysis would, you know, with overwhelming efficacy, would just end the trial? Or just what are the different scenarios from this interim analysis? Ofer GonenCEO at MediWound00:23:20Yeah, thank you for the question. So, the interim analysis will not stop the trial. A phase III study for such a huge indication, we're speaking about 1 million patients annually in the United States. A phase III study with 216 patients is considered very small. I do not anticipate FDA to approve a drug based on a phase III study with only 140 patients. The reason that we are doing an interim assessment, it's just an assessment for the sample size. If we see currently the trial is planned with for 90% power for succeeding in the trial, in both primary endpoints. Ofer GonenCEO at MediWound00:24:14We want to make sure that after 140 patients, we are on track to achieve that. If we need to increase the number by, I don't know, 20 patients, 30 patients, to be sure that we are going to succeed in the trial, it will be done. Most probably, that after the interim analysis, we will continue the trial as planned without changing anything. François BriseboisManaging Director and Senior Analyst at Oppenheimer00:24:38Thank you. Operator00:24:41The next question comes from RK at H.C. Wainwright. Please go ahead. Swayampakula RamakanthManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:24:48Good morning, Ofer. How are you doing? Thanks for taking my questions. You know, in your prepared remarks, you said you have secured orders for $24 million from Vericel. Do they have a minimum every year or how are these orders set up? Ofer GonenCEO at MediWound00:25:16Well, I didn't say that we secured $24 million from Vericel. We said we secured $24 million for the year 2024. Vericel is only one of our revenue channels. So we have an agreement with Vericel. They'll tell us, they tell us in advance, how much they anticipate for the year. We didn't disclose the number, and they are getting it, as they request. So for 2024, for instance, we already got the binding order for Vericel. Some of it was already shipped to them, and some of it is being manufactured. Swayampakula RamakanthManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:25:58Thank you for that. And then, in terms of the next data that you're planning to publish, so would we see that, would we see some of that, you know, this year, or do you expect it next year? And how is that going to help, you know, in reimbursement and also in your conversations with private payers? Ofer GonenCEO at MediWound00:26:33Are you speaking about NexoBrid? Swayampakula RamakanthManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:26:35Yeah. Ofer GonenCEO at MediWound00:26:37Okay, so, don't hold your breath. We are going to the 239 patient data that we are about to share the data by the, in the second half of the year, are patients that are treated in real life. I wouldn't expect something different than what we saw in the phase III study. The efficacy of NexoBrid is so robust. You saw it in the trial, 93% versus, I don't know, 4%. The, so it will be very robust. I do not expect anything different than with what we saw. Ofer GonenCEO at MediWound00:27:22As for the impact on the reimbursement, Vericel is doing a great job in having this treatment approved by P&T committees in hospitals in a specific price, and I think it won't make a change at all. Swayampakula RamakanthManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:27:41Okay. And then, in terms of EscharEx, now that you have all your material ready for the start of the study, is there any other approvals or conversations needed between you and the FDA before you start the study? Or is it just IRB approvals that you're waiting for to get the study going? Ofer GonenCEO at MediWound00:28:12So the process is quite clear. Since we manufactured the clinical batches and waiting for stability, it's only 30 days. Let's assume it will be done in the next couple of weeks. After that, we submit a protocol that we already got a guidance and approval from EMA and FDA. We'll submit the protocols, and unless they see something which is which is very different than what we agreed on, we will get a clearance or no objections in the next the 30-day following following the submission. After that, the IRBs is also something technical. I wouldn't expect the... We do not expect any delay in our guidance of initiating the trial in the second half of this year. Swayampakula RamakanthManaging Director and Senior Healthcare Analyst at H.C. Wainwright00:29:00Okay, thank you very much. Thanks for taking all my questions. Ofer GonenCEO at MediWound00:29:03Thank you, RK. Operator00:29:07The next question comes from Michael Okunewitch with Maxim Group. Please go ahead. Michael OkunewitchSenior Analyst at Maxim Group00:29:19Hey, guys. Thank you so much for taking my questions today. Ofer GonenCEO at MediWound00:29:24Hi, Michael. Michael OkunewitchSenior Analyst at Maxim Group00:29:24So, I guess first off, just to talk about the Medicare changes that you mentioned earlier. In the phase III, will you be looking at the difference in the number of required tissue applications just to potentially have data addressing those claims directly? Ofer GonenCEO at MediWound00:29:45Well, it's a great question. Barry, can you please address it? Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:29:51Certainly we will, you know, be capturing. We're not gonna change the protocol of our study in anticipation of any changes that are being made in Medicare. But we will absolutely capture the data in hopes that it's reflective of, you know, where those changes land. I think, you know, one of the benefits that, that obviously in, in the study is that we get this head start. And so, as the wounds get to be completely debrided and completely covered with granulation tissue, we get to start with active closure sooner, and it stands to bear, given the data that already exists in the published literature, that there's gonna be more that close in our arm and close with these limited number of tissues, and four, than there would be in the control arm. Barry WolfensonEVP of Strategy and Corporate Development at MediWound00:30:49So either way, we stand to benefit. Michael OkunewitchSenior Analyst at Maxim Group00:30:53All right. Thank you. And then, with regards to the phase III, now that, you know, you're getting pretty close to getting that started, do you have any updated expectations regarding the enrollment rate and the time to that interim data? Ofer GonenCEO at MediWound00:31:10So, with the low number of patients that we anticipate to recruit, the 216 patients, and also we have limited competition. Look at clinicaltrials.gov, you will not find a clinical trial with VLU patients. We are confident for a very quick patient enrollment. It should take us after six months of a start-up period, it will take us additional 18 months to finish and execute the protocol. Michael OkunewitchSenior Analyst at Maxim Group00:31:45All right. Thank you very much. And then just one last one from me. Ofer GonenCEO at MediWound00:31:48Thank you. Michael OkunewitchSenior Analyst at Maxim Group00:31:48Just a point of clarification. Have you met with the FDA on the temperature-stable DoD formulation and are waiting for feedback, or are you still expecting to meet with them in the next couple weeks? Ofer GonenCEO at MediWound00:32:06This is a great question. So, as I told earlier, we got quite a significant funding from the DoD to develop this temperature-stable formulation. We already approached the FDA regarding the product development path, and we are anticipating the feedback, which will be in the second half of 2024. Michael OkunewitchSenior Analyst at Maxim Group00:32:34Thank you very much. Ofer GonenCEO at MediWound00:32:36Thank you. Operator00:32:40This concludes our Q&A session. I would like to turn the call back over to Ofer Gonen for closing remarks. Ofer GonenCEO at MediWound00:32:51Thank you everyone for joining us today. We look forward to updating you again in our next quarterly call. Operator00:32:59The conference has concluded. Thank you for attending today's presentation. You may now disconnect.Read moreParticipantsExecutivesBarry WolfensonEVP of Strategy and Corporate DevelopmentHani LuxenburgCFOOfer GonenCEOAnalystsDan FerryManaging Director at LifeSci AdvisorsFrançois BriseboisManaging Director and Senior Analyst at OppenheimerJosh JenningsManaging Direcotr and Senior Research Analyst at TD CowenMichael OkunewitchSenior Analyst at Maxim GroupSwayampakula RamakanthManaging Director and Senior Healthcare Analyst at H.C. WainwrightPowered by