MediWound (NASDAQ:MDWD) reported first-quarter financial results on Wednesday. The transcript from the company's first-quarter earnings call has been provided below.
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Summary
MediWound reported a decrease in Q1 2026 revenue to $1.5 million from $4 million in Q1 2025, primarily due to the timing of BARDA-related revenue and postponed shipments.
Escharx's Phase 3 study timeline has shifted by a quarter, but the company is implementing measures to support enrollment, such as patient assistance programs.
The company reaffirmed its full-year 2026 revenue guidance of $24 million to $26 million, expecting a revenue ramp-up in the second half driven by government-related contracts.
MediWound expanded its Chronic Wound Collaboration Network with Medline joining and highlighted the strategic importance of Nexobrid, including a new 10-year BARDA contract worth up to $197 million.
The company is advancing its expanded Nexobrid manufacturing facility and expects to complete necessary operational modifications by the second half of 2026.
Full Transcript
OPERATOR
Good day and welcome to the Metowound first quarter 2026 earnings conference call. All participants will be in listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question you may press star then one on your telephone keypad and to withdraw your question, please press Star than two. Please note today's event is being recorded. I'd now like to turn the conference over to Dan Ferri of LifeSci Advisors. Please go ahead.
Dan Ferri
Thank you operator and welcome everyone. Earlier today, Premarket Open MediWound issued a press release announcing financial Results for the first quarter ended March 31, 2026. You may access this press release on the company's website under the Investors 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 and 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 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, and Hani Luxenberg, Chief Financial Officer. Barry Wolfenson, EVP of Strategy and Corporate Development, is also participating in today's call. Following our prepared remarks, we will open the call for Q and A. Now I would like to turn the call over to Ofer Gonen, Chief Executive Officer of MediWound Ofer.
Ofer Gonen (Chief Executive Officer)
Thank you, Dan and good morning everyone. During the first quarter of 2026, we continue to execute against our key strategic priorities, advancing Escharx towards commercialization and expanding the global role of NexoBrid. While the timeline for Escharx Phase 3 value study has shifted by 1/4, the underlying momentum behind the program continues to strengthen. During this quarter, we expanded our Chronic Wound Collaboration Network, generated additional clinical and scientific validation for both Escharex and Nexobrid and continued to see strong engagement from strategic collaborators and the broader wound care community. We continue to advance our expanded Nexobrid manufacturing facility toward commercial readiness and further strengthen long term opportunities with industry leaders and government partners across our portfolio. Let me start with an update on Escharx. Enrollment continues in the global Phase 3 value study in Venus Lake Ulcers. With more than 30 sites active across the United States, Europe and Israel, recruitment has progressed more gradually than originally anticipated, primarily due to two operational factors. First, certain European sites required ancillary related regulatory adjustments which have been now completed and we expect the study to reach the targeted 40 active sites within weeks. Second, the travel and visit requirements associated with the protocol created participation challenges for the older and medically complex VLU patient population. To support enrollment and reduce participation burden, we implemented patient assistance measures including hotel reimbursements, transportation services, and facilitated access to enhanced care. Importantly, given how quickly Escharx works, the protocol requires the daily wound assessments to determine the exact day complete debridement is achieved. This represents a shift from measuring debridement outcomes over weeks. While this creates operational complexity in the study, it may ultimately reflect one of Escharex's key clinical and commercial advantages in real world practice. Investigator engagement and site participation remain strong across all regions and we expect the interim sample size, reassessment and the enrollment completion by the end of the first quarter of 2027. At the same time, we continue to see expanding commercial clinical and scientific validation supporting the broader opportunity of Escharex across the chronic wound care market. Medline, a global leader in medical, surgical and wound care products, has joined our collaboration network together with Coloplast, Kerecis, Convotec, esit, Malneca, Solventium, bbrown and Mimedics. Our collaborators now include essentially all the major advanced wound care companies relevant to the program. As part of the collaboration, Medline will provide its class leading skin protectant Marathon for the upcoming DFU Phase 2 study. Marathon is designed to protect tissue surrounding the wound while Escharx performed its debridement activity within the wound bed. A peer reviewed US Expert consensus document published in Wound Journal emphasized the need for effective, easy to use and less invasive debridement approaches in chronic wound care, a conclusion that aligns closely with the clinical profile and positioning of Escharex. We also presented new clinical data and new preclinical data at the whs, SAWC and Yuma conferences, highlighting Escharex's clinical benefits, distinct mechanism of action and broad potential across venous leg ulcers, diabetic foot ulcers and pressure ulcers. Turning to Nexobrid during the quarter we continue to see growing commercial adoption, clinical recognition and strategic interest in nexobridge across both traditional burn care settings and government preparedness initiatives. Vericel reported continued growth in both ordering centers and total orders across the United States burntare market reflecting ongoing adoption trends. Most importantly, Veristel was also awarded a 10 year BARDA contract valued at up to $197 million to support Nexo real procurement, vendor management, inventory services, potential blast trauma indication development and next generation manufacturing and formulation capabilities. We expect BARDA related procurement and development to begin during the second half of 2026. This new 10 year bada contract builds on approximately $138 million already received from BARDA and the Department of War over the past decade, further solidifying the significance of Nexobrid as a strategic asset in mass casualty burn response and national preparedness. Importantly, the burn care community continues to move in the same direction. Newly published national consensus guidelines from Japan and the UK now added to existing recommendation from the WHO and countries including Italy, Spain, Romania and Poland. To support this global demand, we remain focused on bringing our expanding manufacturing facility online. We are implementing modifications identified during a recent EMA pre audit and we expect to complete those implementations activities during the second half of 2026. With that, I'll turn on the call to Hani Hani
Hani Luxenberg (Chief Financial Officer)
thank you Ofer and good morning everyone. Let's turn to our financial Results for the first quarter of 2026. Revenue for the quarter was 1.5 million compared to 4 million in the first quarter of 2025. The decrease was primarily attributable to timing of BARDA related revenue as well as postponed shipment related to regional conflict. Gross profit for the quarter was 0.3 million, representing a gross margin of 21.9% compared to gross profit of 0.7 million, or a gross margin of 18.7% in the prior year period. Research and Development expenses were 5.2 million compared to 2.9 million in the first quarter of 2025, primarily reflecting continued investment in the EschaRex Value Phase 3 study. SGA expenses total 3.6 million compared to 3.1 million in the same period last year. Operating loss for the quarter was 8 million compared to 5.2 million in the first quarter of 2025. Net loss was 3 million or $0.23 per share compared to a net loss of 0.7 million or $0.07 per share in the prior year period. Adjusted EBITDA loss was 7 million compared to a loss of 4 million in the first quarter of 2025. Turning to our balance sheet, as of March 31, 2026 we had 45 million in cash, cash equivalents and deposit compared to 54 million at year end 2025. During the first quarter, net cash used in operating activity was 9.6 million, including the impact of foreign exchange movement between the US dollar and the Israeli Shekel. Our balance sheet also benefited from 1.2 million received under the European Innovation Council or EIC Accelerator Grant Program as well as 0.7 million received from the exercise of Series A warrants subsequent to quarter end. That concludes my review of the financial offer. Back to you.
Ofer Gonen (Chief Executive Officer)
Thank you Chany. We continue to make meaningful progress across our core strategic priorities advancing Escharx value study, broadening industry validation, expanding Nexobrid commercial and government footprint, and preparing our expanded manufacturing facility for commercial readiness. Based on the expected timing of the government related procurement and the development revenue in the second half of the year, we are reaffirming our full year 2026 revenue guidance of 24 million to $26 million. Our focus remains on disciplined execution as we position the company for a potential inflection point in the next phase of commercial growth.
OPERATOR
Thank you. We will now begin the question and answer session. To ask a question you may press Star then one on your telephone keypad and to withdraw your question please press Star then two. Today's first question comes from Josh Jennings at TD Cowan. Please go ahead.
Josh Jennings
Hi good morning Ofer and Hani. Thanks for the update. Wanted to just ask on the value study and understand that there is some complexities in terms of evaluating some of the older patients and you describe that well. Are there any other risks in terms of getting the interim analysis done by the end of 1Q27? And has this these adjustments been made already and what are you seeing to date that gives you confidence that 1q27 is the appropriate new timeline?
Ofer Gonen (Chief Executive Officer)
Hi Josh, good to speak to you. As I said, indeed the enrollment has progressed more gradually than originally anticipated. But importantly this is not related to, I don't know, safety, efficacy or protocol concern. As I said in my prepared remark that the slower pace is primarily reflected by various operational factors that we believe are behind us. They are associated with running very large multinational VLU study, the largest in a few decades. And those operational challenges were, as I said, ancillary related regulatory adjustments at certain European sites. And it is done. We estimate that we reach approximately 40 active sites within weeks. We have also implemented targeted measures to support recruitment momentum with the transportation support reimbursement programs and additional patient assistance initiatives. So according to what we see, believe and understand from how this study runs, we expect the enrollment to be completed by the end of the 2027. I have to emphasize that we are focusing on making sure that the right patients are included in the study, not patients that placebo can cure the wound or not patients that even Escharex cannot move the needle for them. So it takes time but we feel that we are around nearing the end.
Josh Jennings
Thanks for those extra details. Appreciate it. And just in terms of the expanded manufacturing capacity for NexoBrid and looking at the regulators and the updates that you shared on the call, the FDA inspection is planned in early 2027. Any just next steps on getting the FDA in there? I mean what are the steps in front of that inspection occurring in 2027 and and when should we expect that facility to come online to be able to supply Nexobrid product in the U.S.
Ofer Gonen (Chief Executive Officer)
yeah, so indeed the U.S. inspectors are supposed to come very early 2027. But in order to do that we need to finalize with the EMA first. As you know it's a very complex biologic manufacturing and the transfers includes all kind of process validations, comparability, stability and regulatory reviews. These activities are progressing but they require very careful and disciplined execution. We had during the quarter we completed an on site pre audit from ema. They identified all kind of several recommendations that are operational modifications. We are now implementing them and as I said in the call, we expect to complete these activities during the second half of 2026. The feedback is operational in nature. It doesn't have anything related to product quality, safety or comparability concerns. So we think that we are on the right track.
Josh Jennings
Understood, Appreciate thanks a lot of. Thank you.
OPERATOR
And our next question today comes from Jeff Jones at Oppenheimer. Please go ahead.
Mira
Hi, this is Mira on for Jeff. Thanks for the update. Just a couple questions regarding the manufacturing facility and the EMA pre audit. Just wanted to understand sort of the impact of the recommended modifications by the EMA to the facility on material already manufactured. And what is your confidence in being able to sell that material out of the new facility before year end and sort of that timeline to complete these implementation of these fixes. And would the EMA have to reinspect this? Thank you.
Ofer Gonen (Chief Executive Officer)
Hi Mira, good to have you on. So as I said responded to Josh, it wasn't the inspection it was a pre audit by the EMA and they identified several recommended operational modification and when agency recommends something, you know it's not a real recommendation, you need to do that. So we are now implementing it according to what we understand. We can finish everything as we planned during the second half of 2026. The feedback was only operational, nothing related to the comparability of the product, the safety of it. And these are the things that are really worrying in manufacturing transfer of biologics. So we think that we're in a good place.
Mira
Great, thanks. Just one additional question on the BARDA contract. Was wondering if you could comment on the portion of the base Barda contract, that 35 million that goes to NexoBrid Procurement and how you would expect that to flow to MediWound versus Varicel. Thank you.
Ofer Gonen (Chief Executive Officer)
So the only thing that I can share about at this stage at the BARDA contract is that the $197 million is a 10 year contract between BARDA and Vericel. It contains five components procurement, we share it with Vericel, VMI management, Vericel is running that and manufacturing readiness and next generation formulation, another indication for blast trauma. We have a big share in bringing that to the market. Certain elements in the BARDA framework also include the room temperature stable formulation which is a program that initiated back in the days by the Department of War and we expect those revenues to kick in in the beginning of the second half of 2026. Unfortunately I cannot tell you at this stage what is the share, who gets what and what is the portion of Manyone there.
Mira
Thank you.
OPERATOR
Thank you. And our next question comes from RK at HC Wainwright. Please go ahead.
RK
Thank you. Good afternoon. Ofar and Hani, a couple of questions from me. So just thinking through the program with Eschrx beyond the current study. Just trying to have an idea of how the additional studies which you are planning, especially on the indication expansion, the DFU and investigator-initiated trial on pressure ulcer, how are those the plans for those studies and how are those studies progressing?
Ofer Gonen (Chief Executive Officer)
Hi RK and thanks for joining. So as we mentioned, the phase 3 value study in VLU remains the primary focus of the Escharx development program. And this is the company's key value driver as you can imagine. In parallel we are conducting supportive studies that are required for regulatory submission which is PK study and human factor study that we are about to start to start in the second half of the year. We are also advancing a head to head phase study versus collagenase or Santyl and all kind of other non surgical standard of care modalities. Also to strengthen the differentiation between us and to support between us and competition and to support future market access discussions. Beyond VLU, we are expanding Escharex into additional chronic wound indications. As we already communicated, we're about to start a phase two study in diabetic foot ulcers in 2H26 as well as investigator initiated trial in pressure ulcer which is planned also for the second half of 2026. This structured program is designed to support the regulatory approval, the competitive positioning of Escharex and of course the long term commercial expansion across the major chronic wounds segments.
RK
Thank you. The second question is on the, on the revenues. So there is a statement saying some of the shipments had to be postponed because of the regional conflict. So just trying to understand, you know, what sort of how these shipments are going to be moved, you know, into the, into the next three quarters. And also as you reconfirmed your guidance for the year 24 to 26 million, which means quite a bit of it is going to show up in the next nine months. Out of that, you know, is how much is next upgrade revenue based income and how much is, you know, the income that you can get from the BARDA. Contract approval.
Ofer Gonen (Chief Executive Officer)
Hi rk. So the first quarter revenue was relatively low primarily as said due to timing. We did not have BARDA related revenue in the quarter and certain shipments were indeed postponed due to the regional conflict. Those postponed shipments have already been completed. So, so this was a timing issue. As a result we expect looking ahead, we expect revenue to be weighted toward the second half of 2026 driven primarily by the expected ramp up in government related development services and procurement activities. So our reaffirming 2026 guidance of 24 million to 26 million is as you understand supported by expected government related development services with burn mass casualty preparedness. So we are quite confident that the second half of the year will do the ramp up and we still referring our guidance for the revenue this year.
RK
Is it possible for me to ask one more question please? So on the Medline partnership, how does that relationship help in the overall development of the product itself and what do they bring to the table just so that we understand their contribution to this development cycle.
Barry Wolfenson (EVP of Strategy and Corporate Development)
Barry, do you want to speak on this? Sure, absolutely. Hi Arkay, thanks for the question. Generally as an overall comment, obviously we believe that the level of industry engagement around Escharx is highly significant. As Ofer mentioned in his comments with Medline joining this quarter, our Collaboration network essentially comprises all of the major relevant advanced wound care companies. So along with Medline, it's Coloplast, Kerasis, Combatec, Essidi, Munlica, Solventum, Vibron and Mimedx. These collaborations reflect growing recognition that chronic wound care continues to need an optimally effective, easy to use, non surgical debridement solution which we offer with Escharx. And again, generally speaking, standardizing these key products used in both arms of the study, allowing us to only change one thing, active versus control helps to minimize variability in the various studies and thus yield the best results. Regarding Medline specifically, the product that they're going to provide is again for the DFU study and it's their class leading cyanoacrylate based product, Marathon. So its job is to protect the healthy skin that surrounds the wound, which is an important component of standard of wound care. And that allows Escharx to really just do its job within the wound bed itself. So the collaborators get the benefit of having their products as standard of care and some of the largest, most substantial clinical studies in the field of advanced wound care, which could have meaningful commercial impact for their brands. You know, Medline will be looking at data after the study with regard to the health of the surrounding or periwound tissue around the wounds to see if indeed use of their product in a large scale study helped to keep all of that periwound in very good condition. From our perspective, the relationships with the research collaborators are strong and any one of them could develop into a key strategic partner as Escharx approaches commercialization.
RK
Perfect. No, thank you. Thank you all for taking all the questions. Appreciate it.
OPERATOR
And our next question today comes from Chase Knickerbocker at Craig Hallam. Please go ahead.
Chase Knickerbocker
Good morning. Thanks for taking the questions. Maybe just to start, could you elaborate a little bit more on that regulatory change that's causing some issues in Europe? I know you talked a little bit about it last quarter, but maybe if you'd just remind us. And then is this responsible for the entirety of that difference between the current kind of 30ish sites versus kind of the 40 target? Is that delta of 10 all in Europe?
Ofer Gonen (Chief Executive Officer)
Hey Chase, good to have you on with us. Yes, first of all, the 10 sites that we're speaking about, all of them are European ones and they will be open within weeks. As I think I shared with you in the past, specifically some of the ancillaries that we need to import to Europe are a little bit problematic. Specifically without mentioning the brand Cellular tissue products are not or were not allowed in specific countries in Europe. And it was a nightmare to bring them in. And even if we had some resolutions, they were very local. And to make it on a global scale was a little bit complicated. But now we can officially tell you that we are after it and all the sites are being open and it is going to be executed. What was the second part of the question?
Chase Knickerbocker
Sorry, you got both there. Maybe just secondly, as far as what the 1Q27 timeline kind of assumes for an enrollment rate, does it assume kind of an acceleration? I mean, maybe just talk about the assumptions you're making within that. And then secondly, just as it relates to some of those changes around the travel reimbursement, et cetera, have you seen kind of an improvement in enrollment rates already from that?
Ofer Gonen (Chief Executive Officer)
So Barry will address the second part of the question about the changes. But as for the first Q of 2027, our assumption that the enrollment per the number of patients per site to be enrolled per territory will be maintained. We will have more sites, and we had some, and eventually we'll get there. As I said in the beginning of the call, our main motivation, since there is a huge need for biologics, and Barry will elaborate on that in a second. There is a huge need for biologics in the market. We just need to make it to the finish line and make sure that the trial is success so there is no compromise in adding patients with all kind of exclusion criteria that we think will be too easy to cure for placebo or too tough to cure for escharrex. We are keeping them out. We have more than thousands of patients that were already screened for this study. So it means that there isn't a lack of patience. We just need to make sure that the patients that are enrolled are the right ones in order for us to be able to replicate the data that we had in previous studies. Barry, do you mind addressing the second part of the question?
Barry Wolfenson (EVP of Strategy and Corporate Development)
Sure. I think. Hi, Chase. I think that the question was directed towards whether or not these changes have impacted enrollment. And I guess what I would say about that is not likely. As Ofer just mentioned, we've had so many patients screened already, it's not for lack of patients. And also talking to the sites before the study and during this last year, none of them said that anything having to do with reimbursement changes was impacting their ability to enroll patients or not. And just in general, what Chase is referring to is this major change in the Medicare physician fee schedule that happened at the end of last year, which was a major change, reclassifying the skin substitutes to be paid as incident to supplies and establishing a standardized per square centimeter payment, which really lowered the overall sort of amount of dollars, if you will, flowing into that segment. So much so that that CMS itself stated that the change is expected to reduce Medicare spending on those skin substitutes by nearly 90%. So which effectively translates to around $12 billion out of what was a $14 billion segment. That in turn will drop the whole U.S. chronic wound care market from around 18 billion down to 5.5 billion. And in fact, over the last month or so, we've heard leading CTP companies reporting year over year declines in sales of around 60% as Medicare closes that loophole. Setting aside the clinical trial environment from a commercial opportunity, differentiated products outside this reimbursement construct will definitely stand out. Escharx, for example, if approved, enters into a segment where a legacy product generates $400 million per year and it places it as one of, if not the most valuable near term asset in the field of wound care. Given the dramatic drop off of these ctps, certainly the larger global wound care companies will very likely all shift their attention to products with higher order levels of regulatory approval. Blas NDAs, PMAs. And ours is one of the very few of those in late stages of clinical development. And I'd add it's the only one heading into an existing proven category. So from while it doesn't really impact or doesn't seem to have impacted the clinical study from a commercial perspective, this change is enormous for us.
Chase Knickerbocker
Helpful color guys. Thank you.
OPERATOR
And our next question today comes from Michael Okunewicz with Maxim Group. Please go ahead.
Michael Okunewicz
Hey there. Thank you so much for taking my questions today. I think to start off, I'd like to ask a little bit about the consensus document published in Wounds and in particular, if you could expand on what the driving rationale for the consensus on less aggressive methods earlier in the debridement course and what this could mean for Escharx adoption. Is this something that could further build on that expectation that something like Escharex could expand the share of enzymatic debridement in the overall chronic wound debridement segment. I'd just like to get your thoughts on that.
Barry Wolfenson (EVP of Strategy and Corporate Development)
Hi Michael. I think, Barry, it's the best that you respond to that. Okay, sure. Hi Michael. Thanks for the question. You know, we viewed the recent consensus publication, which was in wounds, as an important external validation of the direction that the field is moving to Your question specifically about why more of a focus on less invasive modalities early? I think it's just to allow for more broad access. The higher level of complexity of the intervention, the more training that someone would need to do that. And if you know much about the wound care market, you know that wounds are treated in lots of different places from nursing homes, in home care, obviously in the wound clinics and physicians offices, all the way up to and including hospitals of course. And so one of the charts that they have in the consensus document, they talk about it almost like a chute. Not like, but they talk about it as a chutes and ladders kind of approach where you start off at the base with these more easy to use products and then you progressively go higher and higher as it's required and then even after you get to the top, as you sort of come down from that, you might need kind of check ins if you will for maintenance debridement with the more easy to use products overall, the way that we see it and to your question of what does this really translate to for Escharx, the way that we view this, not that they used these words in that consensus document, but the very accurate picture that they drew of the market, the segment is one of a lot of confusion and a lot of moving parts. And the reason for that is the products that they consider to be first line which are autolytic hydrogel types of moist wound care and the current enzymatic product are not deemed to be optimally clinically effective. And yes, they could be used in all settings. Yes, you don't need a lot of training to do them. But the debridement is measured in weeks. So that kind of forces clinicians hands to go up that ladder and get to more invasive approaches. How Eschrx changes that entire dynamic is by yes, having a product that's easy to use, yes, having a product that could be used across all settings but most importantly is optimally effective. Where debridement can be measured in days. According to the data from third party research, we do believe that because of that change that Escharx will significantly increase the market size of the overall enzymatic debridement market. When we look at from a pricing perspective and a relative desire to switch to Escharx between diabetic foot ulcer. While Santyl is around $400 million a year for Escharx, we believe that peak sales reaches up to around 831 million just from venous leg ulcers and diabetic foot ulcers alone. So yes, we do anticipate a good amount of market expansion.
Michael Okunewicz
All right, thank you. And then just one more for me before I hop into the just with the enrollment challenges and value, are there any lessons learned that you think you can carry over to streamline future development for Escharix, whether that's for the supplementary studies or for the potential expansion studies into DFU and pressure ulcers?
Ofer Gonen (Chief Executive Officer)
Well, there are many lessons, tactical lesson learned. The only one that I think think is a change that we will take into account in future trials is that the enrolling rate, which is half a patient per site per month, which was a correct number when there was Covid, people were looking for excuses to go out of their home. Physicians offices were empty. These numbers should be reduced in our future calculation. When we say end of Q1, we are counting on a lower number making sure that we recruit the right patients. So all the others, additional money for transportation, make sure not to import to Europe or kind of complicated products. We are after that and I don't think it will be an issue next time.
Michael Okunewicz
All right, thank you very much.
OPERATOR
Thank you. And our next question today comes from Scott Henry and agp. Please go ahead.
Scott Henry
Thank you. Good morning or afternoon depending on your location. A follow up, a bit of a follow up on RK's question, perhaps a little more specific. How dependent is 2026 revenue guidance on increasing manufacturing capacity? And if that comes in towards the back part in Q4, is that a risk or can you build inventory ahead in such that you ship a lot in that quarter? Just trying to get a sense as we get later into the year.
Ofer Gonen (Chief Executive Officer)
So. Hi Scott, good to hear from you. So I'm following up Hannah, if this is okay on what you said earlier. So we the forecast of 2026 is dependent on substantially on development services from all kind of government related agreements. Specifically we have some flexibility. It's not that our guidance of 24 to 26 is assuming specific revenue from products or from revenue from development services. We know that we can do either this one or that one. We feel quite comfortable with the guidance and we are not dependent specifically on the manufacturing capacity.
Scott Henry
Okay, great. Thank you. And then when we think about the development services revenue, how should we think about 2Q? Should I'm assuming there was none in Q1? Should we expect that to sequentially go up through the year or should 2Q be perhaps a little bigger than that? Just trying to get a sense of that.
Ofer Gonen (Chief Executive Officer)
So looking ahead, we expect revenue to be weighted toward the second half of 2026, primarily from government related development services. We still have some revenue from development services in the first half, but it's relatively very low compared to what we expect in the second half. Don't forget that we still have an agreement with. We have an agreement also with the Department of War and Development Services there. So the assumption that it is zero is not the right assumption, but definitely it will be weighted towards the second half of the year.
Scott Henry
Okay, thank you. And just one clarification. I thought I heard earlier in the remarks you mentioned that the US Manufacturing capacity expansion somehow hinged on the EU manufacturing capacity expansion. Did I hear that correct? Because that would seem unusual that the two would be related. But I want to follow up on that.
Ofer Gonen (Chief Executive Officer)
Yeah, it's a technical constraint. Every product that is shipped from Israel, from the United States. From Israel to the United States needs to get an approval from the local agency. The local agency is considered the European one. So before I get the approval from the EMA or Israeli local agency, I cannot ship to the United States. But again, these are not different requirements. So I wouldn't. I wouldn't spend too much in order to understand it. But it is what it is. We need to get, okay, clearance from Israel and then we can ship to the United States and then we can call for audits.
Scott Henry
Okay, great. Thank you for that clarification and thank you for taking the questions.
OPERATOR
Thank you very much. Thank you. And that concludes our question and answer session. I'd like to turn the conference back over to management for any closing remarks.
Management
Thank you, everyone for joining us today. We look forward to updating you again on our next quarterly call.
OPERATOR
Thank you. That concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.
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