管理層發言
Good day, and welcome to the MediWound Second Quarter 2026 Earnings Conference Call. Please note this event is being recorded. I would now like to turn the conference over to Gaia Shamis from LifeSci Advisors. Please go ahead.
Thank you, Chloe, and welcome, everyone. Earlier today, premarket opened, MediWound issued a press release announcing financial results for the second quarter ended June 30, 2026. You may access this press release on the company's website under the Investor tab. I would ask you to review the full text of our forward-looking statements within this morning's press release. 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. These statements may involve risks and uncertainties that could cause actual results to differ materially from expectations and are described more fully in our filings with the SEC. In addition, all forward-looking statements represent our views only as of today, and MediWound assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events or otherwise. This conference call is the property of MediWound and any recording or rebroadcast is expressly prohibited without the written consent of MediWound. With us today are 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. Now I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound. Ofer?
Thank you, Gaia, and good morning, everyone. During the second quarter, we made meaningful progress against our strategic priorities, advancing EscharEx and expanding the commercial and development opportunities for NexoBrid. Do you hear me?
Yes, we can hear you. Please stand by while we reconnect the speaker. Pardon everyone, we have reconnected the speaker. Please proceed.
Okay. Sorry about that. So, thank you, Gaia, and good morning, everyone. During the second quarter, we made meaningful progress against our strategic priorities, advancing EscharEx and expanding the commercial and the development opportunities for NexoBrid. Specifically, the EscharEx global Phase III VLU trial is actively enrolling patients as our assessment of its addressable market continues to grow. For NexoBrid, Vericel reported its strongest quarter since launch, and we entered into a new master service agreement with Vericel following its BARDA contract. Now let's start with an update on EscharEx. The VALU study remains our top priority and our key long-term value driver. Our focus is on execution with enrollment ongoing, targeting the 216 patients across approximately 40 sites in the United States, Europe and Israel. As the study progresses, we are approaching two key milestones: first, the prespecified interim sample size reassessment and the second, completion of enrollment, both expected by the end of the first quarter of 2027. At the same time, we continue to build the broader commercial opportunity for EscharEx. During this quarter, an independent global consulting firm completed an updated U.S. market assessment. Following the expansion of the analysis to include pressure ulcer, this updated assessment now estimates the U.S. annual peak sales at $1.05 billion. This analysis further strengthened our view that EscharEx across multiple chronic wound indications has the potential to address a substantial market opportunity. An investigator-initiated study evaluating EscharEx in pressure ulcers is expected to begin in the fourth quarter of 2026. Our collaboration network across the program now spans essentially all the major relevant advanced wound care companies, including Coloplast, ConvaTec, SD, Molnlycke, Solventum, B. Braun and MIMEDX. Together with the continued progress of the VALU study and the expanding clinical and commercial opportunity, this positions EscharEx as a nonsurgical optimally effective debridement therapy for chronic wounds. Turning to NexoBrid. The U.S. commercial trajectory continues to strengthen. Vericel reported NexoBrid's strongest quarter since launch with record quarterly revenue, hospital unit sales and ordering centers. Approximately 80 burn centers have ordered NexoBrid since launch, reflecting continued adoption and increasing utilization across the U.S. burn care market. Following Vericel's 10-year contract with BARDA valued at up to $197 million, we entered into a master service agreement with Vericel covering NexoBrid and next-generation product development activities. Under the MSA, we expect to begin recognizing revenue in the second half of 2026 through participation in development initiatives, including a next-generation program launched to support the potential expansion of NexoBrid for use in blast and friction-related injuries, leveraging real-world evidence. We continue to advance a room temperature stable formulation of NexoBrid as a nonsurgical debridement solution for battlefield burn care, supported by nondilutive funding from the Department of Defense with a total program budget of $18.3 million. Together, these programs further expand NexoBrid's role in burn care, national preparedness, military medicine and mass casualty response. To support current and future demand, we continue to advance our expanded NexoBrid manufacturing facility. We are implementing the modifications requested by the EMA following the pre-audit and expect to complete this work during the fourth quarter of 2026. Commercial supply from the expanded facility remains subject to regulatory approval and is expected in the second half of 2027. With that, I will turn the call over to Hani.
Thank you, Ofer, and good morning, everyone. Turning to our financial results for the second quarter of 2026. Revenue for the quarter was $3.1 million compared with $5.7 million in the second quarter of 2025. The decrease primarily reflected the timing of BARDA-funded development revenue. Gross profit was $0.3 million, representing a gross margin of 10.9% compared with gross profit of $1.3 million or 23.5% in the prior year period. The lower margin primarily reflected a one-time impact related to the facility scale-up. Research and development expenses were $5.9 million compared with $3.5 million in the second quarter of 2025, primarily reflecting increased investment in the EscharEx VALU Phase III trial. SG&A expenses totaled $3.9 million compared with $3.6 million in the same period last year. Operating loss was $9.5 million compared with $5.7 million in the second quarter of 2025. Net loss was $7.4 million or $0.57 per share compared with a net loss of $13.3 million or $1.23 per share in the prior year period. The year-over-year change primarily reflected noncash financial income. Adjusted EBITDA loss was $8.3 million compared with a loss of $4.5 million in the second quarter of 2025. Turning to our first half results. Revenue for the first half of 2026 was $4.6 million compared with $9.7 million in the first half of 2025, primarily reflecting the timing of BARDA-funded development revenue. Gross profit was $0.7 million, representing a gross margin of 14.4% compared with gross profit of $2.1 million or 21.5% in the prior year period. Research and development expenses were $11.1 million compared with $6.4 million in the first half of 2025, primarily reflecting increased investment in the EscharEx VALU Phase III trial. SG&A expenses totaled $7.5 million compared with $6.6 million in the same period last year, primarily reflecting higher professional services costs and exchange rate effects. Operating loss was $17.4 million compared with $10.9 million in the first half of 2025. Net loss was $10.3 million or $0.80 per share compared with a net loss of $14 million or $1.30 per share in the prior year period. The change primarily reflected noncash warrant revaluation income of $7.7 million in 2026 compared with a noncash warrant revaluation expense of $2.4 million in 2025. Adjusted EBITDA loss was $15.3 million compared with a loss of $8.5 million in the first half of 2025. Now turning to our balance sheet. As of June 2026, we had approximately $36 million in cash, cash equivalents and deposits compared with $54 million at year-end 2025. Cash burn during the first half of 2026 totaled $20 million. Warrants and option exercises generated $0.8 million during the first half, and we received an additional $1.1 million after quarter end. This concludes my review of our financial results. Ofer, back to you.
Thank you, Hani. The second quarter strengthened both our core growth platform. The VALU Phase III program of EscharEx continues to advance toward important milestones, while the updated market assessment and planned diabetic foot ulcer and pressure ulcer studies broaden its long-term clinical and commercial opportunity. NexoBrid continues to gain commercial traction in the United States. At the same time, the MSA with Vericel, the broader BARDA framework, DoD funding, all of that creates meaningful government-backed product supply and development opportunities. Our revenue profile remained weighted toward the second half of 2026, reflecting the expected timing of contributions from the MSA and other government-funded programs. Based on these expected contributions, we are reaffirming our full year 2026 revenue guidance of $24 million to $26 million. Our priorities for the remainder of the year are clear: continue executing the VALU trial, begin recognizing revenue under the Vericel MSA, advance our next-generation NexoBrid programs and complete the EMA-requested modification at our expanded manufacturing facility. We remain focused on disciplined execution across our strategic priorities and on building durable long-term value across our pipeline. Operator?
分析師問答
Our first question today comes from RK Ramakanth with H.C. Wainwright.
This is RK from H.C. Wainwright. Lots going on here. First, regarding the VLU study: do you still plan to complete enrollment and conduct the interim analysis in early 2027? That's my first question. Second, Smith & Nephew recently mentioned on their call that they may be developing a second-generation SANTYL. Are you aware of that, and what is your business intelligence on that molecule? How would that affect EscharEx development going forward?
Excellent. So RK, thank you for joining. The first question is a short answer. Yes, our target of meeting the interim assessment and the enrollment completion is still in the first quarter of 2027. As for the second question regarding Smith & Nephew's approach to potential competition from EscharEx, maybe Barry, do you want to take this one?
Sure. Absolutely, RK. We heard those comments, and we found them interesting. I think the thing that's most notable about the comments was the context where he was talking a little bit about competition. He was talking a bit about his thoughts around EscharEx. But then he said that SANTYL is not a fast debridement option and that it is slow, and because of this that's what's driving their desire to make this second-generation product. It's actually being developed by a company that they've invested in called Certa Therapeutics. The molecule is SN-514. Based on all the publicly available information we've been able to see, we're not aware of this drug having entered into any clinical development in chronic wound patients. We see some activity around burns, but not chronic wounds. And so, while we take any potential competition seriously, EscharEx, as you know, is already in Phase III in chronic wounds, and that gives us what we believe to be a substantial clinical lead.
Based on those comments, does that imply the market is larger than it appears, because SANTYL is clearly not the molecule of choice if it isn't delivering expected results? And secondly, regarding your team's addition of pressure ulcers into the study pool, how is that investigator-initiated trial being conducted, what is your responsibility in it, and will that data be available by the time you're ready to file applications with regulators in the U.S. and the EMA?
Well, I think, more broadly, what I heard you ask, RK, is whether, since SANTYL is not particularly effective and Smith & Nephew is motivated to create a new drug, the inference is that the market is even bigger than what SANTYL is currently supplying. We believe the answer to that is resoundingly yes. That's why, even before including pressure ulcers, we projected peak sales in the $800 million range. With pressure ulcers included, it tops $1 billion. We believe a debridement drug that can achieve complete debridement within four to five days would change expectations for enzymatic debridement. It fits better into the workflows of wound clinics and podiatry offices and would take utilization share not just from sharp debridement but across multiple modalities. So we do believe it greatly expands the market.
So, if we speak about the pressure ulcer study, it's important to mention that the Phase III VALU study in venous leg ulcers is the primary focus of the EscharEx development program. It's, of course, the company's key value driver. The pressure ulcer study is an investigator-initiated trial. So, it's not run directly by us. It's a small study, open-label, 10 to 15 patients, and the initiation is expected in the fourth quarter of 2026. It enrolls pressure ulcer patients. All of them are treated with EscharEx across a week or two. And we are assessing, as usual, debridement, granulation and wound closure. Following this value readout, we plan to approach the FDA and determine what would be required to pursue approvals also for DFU and pressure ulcers.
One last question. This is on NexoBrid. So, it's a two-part question. The first one, what is EMA requesting you to do in terms of the new plant? And at least at the outset, it looks like timelines are moving back. So, is that true in your sense of the world? And also, if things get pushed to second half of 2027, does that mean the real product for the market actually gets pushed into 2028? And the third part of the question is on the CPT code, where do we stand? And is January 2027 still an effective and realistic date?
So I will address the manufacturing facility question. I think there was a confusion. As I said in the call, we completed the EMA pre-audit and the pre-audit process, and they recommended some operational changes that we are about to complete in the fourth quarter of this year, not the fourth quarter of 2027. So, we'll complete all the implementation this year. The feedback that we got was operational in nature, not related to product quality, safety or comparability concerns, which is very important. Once this work is complete, we will begin the manufacturing of NexoBrid in the new facility. Then following submission, review and inspection, we can get approval as early as in the second half of 2027. So, we have a delay. We reported this last quarter, but we are currently on track. As for your second question, the CPT code, Barry, do you want to address it?
To my knowledge, there is no publicly available information regarding any update to a Category 1 CPT code.
The next question comes from Josh Jennings with TD Cowen.
Barry, I wanted to touch on the updated MSA with Vericel. Can you share any additional details on the changes to revenue recognition? Is the major update that you will be recognizing revenue for the development program that’s been expanded to include blast and friction injuries and potentially extending the shelf life of NexoBrid? And second, any updates on the path for the DFU indication in the clinical development program?
Josh, good to speak to you. So let me speak about the BARDA economics and its strategic importance. So as mentioned, in April, Vericel was awarded a 10-year BARDA contract that is valued at up to $197 million. It is covering NexoBrid procurement, vendor-managed inventory, U.S.-based manufacturing readiness, next-generation formulation development and the potential blast and trauma expansion. It's a large, multiyear framework agreement with several components. I understand the appetite for more precision. We are currently not in a position to share additional detail. It reflects confidentiality obligations to Vericel as well as the fact that several elements of the program remain subject to further FDA feedback, which could affect the scope of development and work required. What is concrete today is that the MSA is signed. The first development program, the blast injury and friction injuries program, is underway, and Vericel expects about $6 million of BARDA procurement revenue in the second half. Additional elements, including the room temperature stable formulation and the U.S.-based manufacturing readiness, are areas that we are now in discussions with Vericel and BARDA regarding the scope, timing, technical requirements and potential implementation pathway. So, this is the maximum we can share right now. And as I said, we are about to begin recognizing revenue from that program in the second half of 2026. Regarding the DFU, we have constructive discussions with the FDA and EMA. We got feedback and are aligned on a DFU protocol. The protocol highlights are attached to our corporate deck. We plan to initiate the study in the fourth quarter of 2026. This Phase II DFU study is expected to enroll 50 patients. It's a randomized trial, 1:1 design, EscharEx versus placebo. The primary endpoint is time to complete debridement, which EscharEx is well positioned to deliver on. We see it as a trial that is not overly complicated. As I said earlier, we plan to approach the FDA after the value readout to determine what would be required to pursue approval for that indication as well.
The next question comes from Jeff Jones with Oppenheimer.
One point of clarification on the BARDA contract with Vericel. You noted that Vericel is planning to receive $6 million in BARDA revenue in 2H. How then does that align with the $14 million to $15 million in BARDA revenue that you guys are projecting for 2026? Is that dependent on some of these other pieces that are under negotiation? And then in regards to NexoBrid, looking ahead into 2027 and 2028, how do we think about revenue given the facility now doesn't look to be coming online until 2H 2027?
Okay. Jeff, good to have you on. So as for the first question, the number you mentioned—$14 million—is not exclusively BARDA. We have additional government-related agreements, one of them you are familiar with, which is funding from the Department of Defense. So, expect some news there as well. The MSA with Vericel includes a few components. As I said, I cannot give you at this stage all the components due to confidentiality obligations. Having said that, the first program, which is development of blast and friction burn indications, is on its way. Additional components are currently being discussed and negotiated. As for procurement, MediWound expects to benefit from the procurement that BARDA has with Vericel. It's not one-to-one. We have transfer prices with Vericel, but nothing is disclosed at this stage. When you speak about the amount of development services under the BARDA agreement, it contains a few components and not only one.
Yes. Jeff, we do not actually expect the current facility timeline to have a material impact on our 2026 revenue guidance. Importantly, a meaningful portion of the revenue we expect in the second half is associated, as you know, with government-funded development activity and product supply under existing agreements rather than depending on commercial supply from our expanded facility. So, our $24 million to $26 million 2026 revenue guidance already reflects the current status and the expected timing of our facility.
And as you asked also about 2027 and 2028, our plan is to finish all the modifications by the end of the fourth quarter of this year. The first thing that we are going to do next year is to start manufacturing NexoBrid. So we don't think there will be any impact at all to the expected revenue in 2027 and 2028 for NexoBrid.
The next question comes from Chase Knickerbocker with Craig-Hallum.
Maybe just a little bit more specifics about VALU. Can you just talk about how the enrollment rate has trended sequentially on a per-site basis? And then can you just confirm that all those approximately 40 sites are up and running and enrolling? And then as we think about the expectation for the Q1 resampling, are you assuming any improvement in enrollment trends in that assumption? Or is it just static?
Chase, good to have you with us. As for the VALU study, to protect the integrity of the study, we cannot share patient enrollment numbers or enrollment trends during the conduct of the study. In a multinational study, individual snapshots can be noisy and the advice we are getting is not to share any information. We think the more useful commitment is the milestones. It's the interim assessment and the enrollment completion. What I can say now is that the design hasn't changed: 216 patients, roughly 40 sites, and we expect the interim sample size reassessment and enrollment completion to be by the end of the first quarter of 2027. We do not need any improvement or changes in trends; we are on track.
Yes. And maybe you can just speak to the active sites. Are they all up and running?
Regarding the sites, as we said, we are targeting approximately 40 sites, and we are very close to having them all recruiting. We have less than 10% to reach this target.
Got it. And then as we think about topline data post-last patient in, should we think about it as 12 weeks to the wound healing follow-up and then a month or two for data lock and the like? Or can you walk us through how that timeline will work? And then lastly for Barry: we're seeing a pretty large volume shift in wound care reimbursement from one site of service to another. Can you remind us which sites of service you think EscharEx will predominantly be used in if approved? And where is SANTYL usage concentrated today and how do you expect that mix to change for EscharEx?
Chase, you got it quite accurately. Our plan is to have the interim assessment by the end of Q1. If everything goes well, it takes another quarter or so to get the topline data. After the topline data, it is another few months until the final results.
Most of that shifting has to do with the CMS change to how it reimburses tissue substitute products. Based on the third-party data we've acquired regarding prescriptions of SANTYL, it's fairly well distributed across acute care, clinics, home health and certainly into nursing homes and skilled nursing facilities. We don't see that materially changing, nor do we see that being any different for EscharEx.
The next question comes from Michael Okunewitch with Maxim Group.
So, I wanted to follow up on the question surrounding 2027 revenues and particularly to understand mechanically how that works with your current projections since it's nearly a doubling of the NexoBrid-specific revenues that you are projecting. So, is this a case where there's pent-up demand that would lead to a surge in sales in the fourth quarter once you get that approval? Or can you actually ship the product and recognize revenue before the second half EMA commissioning?
Michael, this is a good question. We are planning to start manufacturing NexoBrid at the new facility at the beginning of 2027. Everything is ready to be shipped once manufacturing is underway and approvals are in place. The demand is there. In the second half of 2027, we can sell significantly more than we are selling now. Currently, our ability to sell is capped by manufacturing capabilities, and in 2027 this limitation will be removed.
All right. And then what is the delay on the EMA side effecting FDA? Is that still one half after EMA approval? Or would these now be contemporaneous?
Mathematically, it's something like three months. The most important milestone is getting the first approval. As I mentioned on the previous call, EMA comes first. Once EMA approval is in hand, we can start selling substantially to the European countries, and then the current facility can be dedicated to the U.S. market and to stockpile for governments. If FDA happens three months after that or five months after that depends on inspections and other factors; I don't think it will materially change the revenue outlook.
And then one last one. In the second half of this year, you are expecting quite a significant uptick in revenues, particularly from development services, well beyond what you've seen historically even when you had BARDA contracts up and running. I wanted to understand what's going to be driving that. Is that primarily the new programs that have been announced taking effect? Or is there some front-loading to the new BARDA contract you signed after the lapse?
Yes. We're reaffirming the $24 million to $26 million revenue guidance for 2026. Since revenue for the first half was $4.6 million, the majority of the year is weighted toward the second half. We expect a meaningful step-up in H2 driven by product supply related to the contracts, development services under the Vericel MSA and other government-funded programs, including Department of Defense funding and the ongoing commercial NexoBrid sales. Under the MSA, we just announced that we initiated the first development program to support expansion into blast and friction injuries, and we expect to initiate additional development programs under the MSA in the near term as well.
The next question comes from Scott Henry with Alliance Global Partners.
Most of my questions have been asked, but I did want to follow up on product sales for 2026. Obviously, the $2.6 million was very strong in 2Q, but first quarter was only $528,000 based on the filings. Would it be better to think about capacity for product sales as kind of the combination of those two, so about $1.7 million to $1.8 million per quarter? Is that kind of how much you can make in a quarter until we get capacity? Or could you duplicate $2.6 million again prior to the capacity expansion?
Scott, as you know, we are not providing granular guidance for product-only sales. I don't think it's right to assume we sold everything that we could. We are capped by capacity, not by demand. Inventory of NexoBrid is currently very limited in most territories and in our facility. Some of the impacts you saw prevented us from generating more revenue were because the facility needed inspections and upgrades. I think it would be more accurate to look at the second quarter as an indication of demand. Last year we were selling everything we had, so perhaps comparing to last year's run rate with some modest improvement is a reasonable approach.
Okay. Thanks for the color. That is helpful. And then perhaps a question for Hani. R&D — should we expect a significant spike still in the second half of 2026? How should we think about the next couple of quarters there?
Scott, the increase in R&D is primarily driven by our VALU Phase III trial, which remains our top strategic priority. We're not providing quarterly R&D guidance, but we are at an elevated level of investment and expect R&D spending to remain elevated as VALU progresses through this phase of our program. At the same time, a meaningful portion of our NexoBrid development activity is supported by nondilutive government funding through BARDA and the Department of Defense. So, while we are investing significantly in VALU, we are being disciplined about where we deploy our own capital.
This concludes our question-and-answer session. I would like to turn the conference back over to Ofer Gonen for any closing remarks.
So thank you, everyone, for joining us today. We look forward to updating you again on our next quarterly call.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.