MediWound Ltd. (MDWD) Q2 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call presented mixed signals. While strategic collaborations and funding are positive, the decline in revenue and increased operating loss are concerning. The Q&A highlighted ongoing projects and potential future benefits but also revealed some uncertainties, particularly regarding patient recruitment and manufacturing timelines. Despite some positive developments, the overall financial health and lack of immediate catalysts suggest a neutral market reaction.
Key Financial Performance
Total Revenue (Q2 2025) $5.7 million, up from $5.1 million in Q2 2024, reflecting a 43% sequential growth and year-over-year increase due to higher product sales and a more favorable revenue mix.
Gross Profit (Q2 2025) $1.3 million or 23.5% of revenue, compared to $0.4 million or 8.8% in Q2 2024, driven by a more favorable revenue mix.
Research and Development Expenses (Q2 2025) $3.5 million, up from $1.9 million in Q2 2024, driven by continuing investment in the EscharEx VALUE Phase III study.
SG&A Expenses (Q2 2025) $3.6 million, up from $3 million in Q2 2024, primarily due to increased share-based compensation.
Operating Loss (Q2 2025) $5.7 million, compared to $4.5 million in Q2 2024, reflecting higher R&D and SG&A expenses.
Net Loss (Q2 2025) $13.3 million or $1.23 per share, compared to $6.3 million or $0.68 per share in Q2 2024, mainly driven by $6.6 million in noncash financial expenses reflecting the revaluation of warrants.
Adjusted EBITDA Loss (Q2 2025) $4.5 million, compared to $3.4 million in Q2 2024, reflecting higher operating expenses.
Total Revenue (First Half 2025) $9.7 million, compared to $10 million in the first half of 2024, a slight decrease primarily due to lower BARDA-funded development revenue as the NexoBrid R&D program nears completion.
Gross Profit (First Half 2025) $2.1 million or 21.5% of revenue, compared to $1.1 million or 10.5% in the first half of 2024, driven by a more favorable revenue mix.
R&D Expenses (First Half 2025) $6.4 million, up from $3.4 million in the first half of 2024, driven by clinical investment in EscharEx.
SG&A Expenses (First Half 2025) $6.6 million, compared to $5.9 million in the first half of 2024, reflecting increased share-based compensation.
Operating Loss (First Half 2025) $10.9 million, compared to $8.2 million in the first half of 2024, reflecting higher R&D and SG&A expenses.
Net Loss (First Half 2025) $14 million or $1.30 per share, compared to $16 million or $1.73 per share in the first half of 2024, reflecting lower noncash financial expenses.
Adjusted EBITDA Loss (First Half 2025) $8.5 million, compared to $6.2 million in the first half of 2024, reflecting higher operating expenses.
Cash Position (June 30, 2025) $32.9 million in cash, cash equivalents, and deposits, compared to $43.6 million at year-end 2024, with $11.9 million used to fund operations, including $2.3 million in CapEx for the new manufacturing facility.
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Operating Highlights
EscharEx VALUE Phase III trial: Actively enrolling 216 patients across 40 sites in the US and Europe. Interim sample size assessment expected by mid-2026. New collaborations with Essity and Convatec established to support trials.
NexoBrid: Continues to gain traction in the US market with 52% YoY revenue growth in Q2 2025. Manufacturing scale-up on track for completion by year-end. Additional $3.6M funding from the US Department of Defense for room temperature-stable formulation development.
US market expansion for NexoBrid: 52% YoY revenue growth driven by increased hospital unit orders and ordering centers.
Manufacturing scale-up: Commissioning of new manufacturing facility on track for completion by year-end to support global growth.
Financial performance: Q2 2025 revenue grew 43% sequentially to $5.7M. Gross profit increased to $1.3M (23.5% of revenue). Operating loss was $5.7M, and net loss was $13.3M due to noncash financial expenses.
Strategic collaborations: New partnerships with Essity and Convatec to support EscharEx trials. Reinforces validation of EscharEx in the wound care ecosystem.
Funding for NexoBrid: $3.6M additional funding from the US Department of Defense, bringing total program funding to $18.2M.
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Risk or Challenges
EscharEx VALUE Phase III trial enrollment: The trial is actively enrolling patients, but the timeline for interim sample size assessment is mid-2026, which could delay actionable results and impact strategic objectives.
Manufacturing scale-up for NexoBrid: The commissioning of the new manufacturing facility is on track, but regulatory authority review and approval could delay commercial output, affecting global growth plans.
Financial performance: Net loss increased significantly to $13.3 million in Q2 2025, driven by noncash financial expenses and higher R&D and SG&A costs, which could strain financial resources.
Cash position: Cash reserves decreased to $32.9 million as of June 30, 2025, with operational funding heavily reliant on warrant exercises, posing a risk to financial stability if warrants are not exercised.
U.S.-based manufacturing for NexoBrid: Future U.S.-based manufacturing is still in planning stages, and delays could impact the ability to meet demand and strategic goals.
Dependency on collaborations: The company relies heavily on collaborations with partners like Essity, Convatec, and BARDA, which could pose risks if partnerships face challenges or fail to deliver expected outcomes.
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Guidance & Outlook
EscharEx VALUE Phase III trial: Enrollment is actively progressing, aiming to enroll 216 patients across 40 sites in the United States and Europe. An interim sample size assessment is expected by mid-2026.
Collaborations for EscharEx: New collaborations with Essity and Convatec have been established to support the VALUE trial and the planned DFU trial. Essity's JOBST medical compression therapy products and Convatec's AQUACEL dressings are integrated into the trial protocols.
NexoBrid manufacturing scale-up: The commissioning of the new manufacturing facility remains on track for completion by year-end 2025. Regulatory authority review and approval will determine the timing of commercial output.
Future U.S.-based manufacturing for NexoBrid: Planning continues as part of collaboration with BARDA. An additional $3.6 million in non-dilutive funding from the U.S. Department of Defense has been awarded to support the development of a room temperature-stable formulation for NexoBrid.
Financial flexibility: The company believes its current cash position, along with potential proceeds from in-the-money warrants, provides financial flexibility to advance key programs and support operational needs through upcoming milestones.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:Are there any other publications related to EscharEx Phase II trial that we should expect in the back half of 2025 or into 2026?
A:There are a few other publications focused on diabetic foot ulcer trials expected around important conferences like DFCon and SAWC. The head-to-head trial comparing EscharEx to collagenase is on track to launch in the second half of 2025, enrolling 45 VLU patients.
Q:Can you review the U.S. facility and BARDA-funded planning and design?
A:The U.S. government is funding the planning and site selection for a domestic backup manufacturing site for NexoBrid. The funding for the facility as a whole will be discussed once costs and location are finalized.
Q:What are the elements of the BARDA RFP for enzymatic debridement products?
A:The BARDA RFP covers stockpiling of NexoBrid, room temperature-stable formulation for nonsurgical debridement, and trauma and blast injury solutions. The program is expected to start in Q4 2025 and last for 10 years.
Q:How will the new compression method for the Phase III VALUE trial be distributed?
A:The compression therapy products from Essity will be used for patients who achieve complete wound closure during the trial's follow-up period. Two versions of Essity's JOBST products will be used: a custom product for uniquely shaped legs and a standardized product.
Q:Does the addition of the JOBST product change the trial timelines?
A:No, the addition of the JOBST product does not change the trial timelines. The follow-up period remains a 3-month period.
Q:Has the patient recruitment and enrollment process for the VALUE study matched expectations?
A:Enrollment is progressing well in the U.S., with most sites active and recruiting. European site activation is slower due to regulatory timelines but is progressing. The trial is generating significant interest.
Q:Will having six different products across pivotal studies demonstrate EscharEx's universal usability?
A:Yes, the use of various products in the studies demonstrates that EscharEx can be used universally with any standard of care products.
Q:What areas are underserved for NexoBrid, and how will new manufacturing address this?
A:Demand for NexoBrid is substantial across all regions, but current capacity limits supply. The new facility, expected to be operational by 2026, will address this demand.
Q:What is the timeline for the DFU trial and feedback from the FDA?
A:Feedback from the FDA on the DFU trial protocol is expected within 90 days, with the trial planned to start in the second half of 2026.
Q:What is the status of the 40 centers for the VLU trial, and is there competition for patients?
A:About 50% of the centers are active, with most U.S. sites recruiting. European sites are expected to be active by the end of Q3. Competition for patients is minimal due to careful site selection.
Q:How will changes in CTP skin substitute reimbursement impact EscharEx?
A:Changes requiring proper wound preparation and clinical evidence for reimbursement will benefit EscharEx, as it excels in wound bed preparation.
Q:When will the new NexoBrid facility be operational, and when will regulatory approvals be filed?
A:The facility is expected to be operational by the end of 2025. EMA approval is expected in the first half of 2026, and FDA approval in the second half of 2026.
Q:Will there be room for NexoBrid expansion in the second half of 2025?
A:No, current capacity limits NexoBrid expansion until the new facility is operational.
Q:What is the current status of BARDA funding and its political environment?
A:BARDA funding is on track, with increased support for NexoBrid and related projects. Political concerns have eased, and the projects are considered a priority.
Q:Will operating expenses increase in the second half of 2026?
A:Yes, operating expenses are expected to increase due to higher R&D expenses as European sites become active.
Q:Are inspection timelines for the new NexoBrid facility on track?
A:Yes, inspections are expected to proceed as planned, with no anticipated delays.
Q:Can BARDA RFP and DoD funding be used for room temperature-stable formulation development?
A:Yes, both BARDA and DoD funding can be used for this development, which is a focus area for both agencies.
Q:Review of Unclear Management Responses
A:Management avoided providing specific numbers for patient recruitment in the VALUE study and did not give granular details on the number of active centers for the VLU trial. Additionally, they did not elaborate on the exact costs or location for the new U.S. manufacturing facility.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
AQUACEL dressing
Advisors LLC
Advisors statement
BARDA parallel
Barry Wolfenson
CMC activity
Capacity expansion
Capital Group
Co LLC
Conference Instructions
Convatec AQUACEL
Convatec Essity
Group LLC
III study
LLC Research
Phase III
Research Division
Series warrant
VALUE Phase
VALUE trial
commissioning manufacturing
completion end
exercise Series
healing
investment
objective
order
partner
period loss
proceeds
share period
track completion
trial patient
warrant exercise
MDWD Transcript
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The earnings call summary presents a mixed picture with both positive and negative aspects. The company shows strong partnerships and financial flexibility, but faces challenges like increased EBITDA loss and dependency on government contracts. The Q&A reveals optimism in sales estimates and market strategy but lacks transparency in revenue breakdown and contract timelines. Overall, the sentiment is neutral as positive elements are balanced by uncertainties and financial challenges.
MediWound Ltd. (MDWD) Q2 2025 Earnings Call Transcript
Unknown8-14
The earnings call presented mixed signals. While strategic collaborations and funding are positive, the decline in revenue and increased operating loss are concerning. The Q&A highlighted ongoing projects and potential future benefits but also revealed some uncertainties, particularly regarding patient recruitment and manufacturing timelines. Despite some positive developments, the overall financial health and lack of immediate catalysts suggest a neutral market reaction.
MDWD Report
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