MediWound (MDWD) การประชุมรายงานผลประกอบการไตรมาส 2 ปี 2026: VALU เป็นไปตามแผน, ยืนยันเป้าหมายผลประกอบการ

ประเด็นสำคัญ

• รายได้ในไตรมาสที่ 2 ปี 2026 ลดลงเหลือ 3.1 ล้านดอลลาร์ จาก 5.7 ล้านดอลลาร์ในปีก่อนหน้า โดยมีสาเหตุหลักมาจากช่วงเวลาของการรับรู้รายได้จากการพัฒนาที่ได้รับทุนสนับสนุนจาก BARDA
• ผลขาดทุนจากการดำเนินงานขยายตัวขึ้นเป็น 9.5 ล้านดอลลาร์ เนื่องจากค่าใช้จ่ายด้านการวิจัยและพัฒนา (R&D) เพิ่มขึ้นเป็น 5.9 ล้านดอลลาร์ ซึ่งสะท้อนถึงการลงทุนในการทดลองทางคลินิกระยะที่ 3 (Phase III) รายการ VALU ของ EscharEx เป็นหลัก
• ผู้บริหารยืนยันคาดการณ์รายได้ตลอดปี 2026 ที่ระดับ 24 ล้านดอลลาร์ ถึง 26 ล้านดอลลาร์ โดยรายได้ส่วนใหญ่จะกระจุกตัวอยู่ในช่วงครึ่งปีหลัง
• การทดลอง VALU ของ EscharEx ในผู้ป่วยจำนวน 216 ราย ยังคงเป็นไปตามแผนสำหรับการประเมินขนาดตัวอย่างระหว่างกาลและการเปิดรับลงทะเบียนผู้ป่วยเสร็จสิ้นภายในสิ้นไตรมาส 1 ปี 2027
• ผลการประเมินตลาดสหรัฐฯ โดยอิสระฉบับปรับปรุงใหม่ ซึ่งขยายขอบเขตให้ครอบคลุมแผลกดทับ ประเมินว่า EscharEx มีศักยภาพยอดขายสูงสุดต่อปีอยู่ที่ 1.05 พันล้านดอลลาร์
• Vericel รายงานว่า NexoBrid มีไตรมาสที่แข็งแกร่งที่สุดนับตั้งแต่เปิดตัว โดยมีศูนย์รักษาแผลไฟไหม้น้ำร้อนลวกในสหรัฐฯ ประมาณ 80 แห่งสั่งซื้อผลิตภัณฑ์ดังกล่าว ขณะที่ MediWound คาดว่าจะเริ่มรับรู้รายได้ภายใต้ข้อตกลงการให้บริการหลัก (Master Service Agreement) ฉบับใหม่กับ Vericel ในช่วงครึ่งปีหลังของปี 2026

ข้อมูลทางการเงินที่สำคัญ

สำหรับครึ่งแรกของปี 2026 รายได้อยู่ที่ 4.6 ล้านดอลลาร์ เทียบกับ 9.7 ล้านดอลลาร์ในปีก่อนหน้า ผลขาดทุนจากการดำเนินงานขยายตัวเป็น 17.4 ล้านดอลลาร์ จาก 10.9 ล้านดอลลาร์ ขณะที่ผลขาดทุน EBITDA ปรับปรุงเพิ่มขึ้นเป็น 15.3 ล้านดอลลาร์ จาก 8.5 ล้านดอลลาร์

ผลขาดทุนสุทธิในช่วงครึ่งปีแรกปรับตัวดีขึ้นเป็น 10.3 ล้านดอลลาร์ หรือ 0.80 ดอลลาร์ต่อหุ้น จาก 14.0 ล้านดอลลาร์ หรือ 1.30 ดอลลาร์ต่อหุ้น การเปลี่ยนแปลงดังกล่าวนั้นหลักๆ แล้วสะท้อนถึงรายได้จากการประเมินมูลค่าใบสำคัญแสดงสิทธิ (Warrant) ใหม่ที่ไม่ใช่เงินสดจำนวน 7.7 ล้านดอลลาร์ในปี 2026 เทียบกับค่าใช้จ่ายจากการประเมินมูลค่าใหม่ 2.4 ล้านดอลลาร์ในปี 2025

MediWound ถือครองเงินสด รายการเทียบเท่าเงินสด และเงินฝากประมาณ 36 ล้านดอลลาร์ ณ เดือนมิถุนายน 2026 ซึ่งลดลงจาก 54 ล้านดอลลาร์ ณ สิ้นปี 2025 โดยมีการใช้เงินสด (Cash burn) ในช่วงครึ่งปีแรกรวม 20 ล้านดอลลาร์

ผลการดำเนินงานทางธุรกิจและการปฏิบัติการ

EscharEx

การทดลอง Phase III รายการ VALU ในระดับโลกสำหรับแผลหลอดเลือดดำที่ขาเรื้อรัง (Venous leg ulcers) ยังคงเป็นลำดับความสำคัญหลักในการพัฒนาของ MediWound การศึกษานี้ตั้งเป้าผู้ป่วย 216 รายในศูนย์วิจัยประมาณ 40 แห่งทั่วสหรัฐอเมริกา ยุโรป และอิสราเอล ผู้บริหารกล่าวว่าบริษัทเหลืออีกไม่ถึง 10% ในการทำให้ศูนย์วิจัยเป้าหมายทั้งหมดเปิดรับสมัครผู้ป่วย

ทั้งการประเมินขนาดตัวอย่างระหว่างกาลที่กำหนดไว้ล่วงหน้าและการเปิดรับลงทะเบียนผู้ป่วยเสร็จสิ้น ยังคงตั้งเป้าไว้ที่สิ้นไตรมาส 1 ปี 2027 หากการทดลองดำเนินไปตามแผน ผู้บริหารคาดว่าจะทราบผลข้อมูลสรุปขั้นต้น (Top-line data) หลังจากนั้นประมาณหนึ่งไตรมาส ตามด้วยผลลัพธ์ฉบับสมบูรณ์ในอีกไม่กี่เดือนต่อมา

MediWound ยังวางแผนที่จะเริ่มการทดลอง Phase II แบบสุ่มในผู้ป่วยแผลเบาหวานที่เท้าจำนวน 50 รายในไตรมาสที่ 4 ปี 2026 การศึกษาในอัตราส่วน 1:1 นี้จะเปรียบเทียบ EscharEx กับยาเทียม (Placebo) โดยมีระยะเวลาจนกว่าจะขจัดเนื้อตายได้สมบูรณ์ (Complete debridement) เป็นตัวชี้วัดหลัก

การศึกษาแผลกดทับอีกรายการหนึ่งที่ริเริ่มโดยผู้วิจัย คาดว่าจะเริ่มต้นขึ้นในไตรมาส 4 ปี 2026 เช่นกัน การทดลองแบบ Open-label นี้จะรับผู้ป่วยประมาณ 10 ถึง 15 ราย และประเมินการขจัดเนื้อตาย การสร้างเนื้อเยื่อสมบูรณ์ (Granulation) และการสมานแผล

NexoBrid

Vericel รายงานรายได้ไตรมาส ยอดขายหน่วยโรงพยาบาล และจำนวนศูนย์ที่สั่งซื้อของ NexoBrid สูงสุดเป็นประวัติการณ์ โดยมีศูนย์รักษาแผลไฟไหม้น้ำร้อนลวกในสหรัฐฯ ประมาณ 80 แห่งสั่งซื้อ NexoBrid นับตั้งแต่เปิดตัว

หลังจากสัญญาระยะเวลา 10 ปีของ Vericel กับ BARDA ซึ่งมีมูลค่าสูงถึง 197 ล้านดอลลาร์ MediWound ได้ลงนามในข้อตกลงการให้บริการหลักที่ครอบคลุม NexoBrid และกิจกรรมการพัฒนารุ่นถัดไป โครงการแรก ซึ่งเน้นไปที่การใช้งานที่เป็นไปได้ในอาการบาดเจ็บจากแรงระเบิดและแรงเสียดสี กำลังดำเนินการอยู่

นอกจากนี้ MediWound ยังคงขับเคลื่อนสูตรตำรับ NexoBrid ที่คงตัวได้ในอุณหภูมิห้องสำหรับการดูแลแผลไฟไหม้ในสนามรบ โครงการนี้ได้รับการสนับสนุนจากเงินทุนแบบ Nondilutive ของกระทรวงสงคราม (Department of War) และมีงบประมาณรวม 18.3 ล้านดอลลาร์

บริษัทคาดว่าจะดำเนินการปรับปรุงการปฏิบัติงานตามคำขอของ EMA ที่โรงงานผลิตที่ขยายเพิ่มขึ้นได้เสร็จสิ้นในไตรมาส 4 ปี 2026 ข้อคิดเห็นดังกล่าวไม่เกี่ยวข้องกับคุณภาพ ความปลอดภัย หรือความเท่าเทียมกันของผลิตภัณฑ์ ทั้งนี้ขึ้นอยู่กับการตรวจสอบและการอนุมัติจากหน่วยงานกำกับดูแล การอุปทานเชิงพาณิชย์จากโรงงานดังกล่าวคาดว่าจะเริ่มขึ้นในช่วงครึ่งหลังของปี 2027

แนวทางการดำเนินงานจากผู้บริหาร

MediWound ยืนยันคาดการณ์รายได้ตลอดปี 2026 ที่ระดับ 24 ล้านดอลลาร์ ถึง 26 ล้านดอลลาร์ ผู้บริหารคาดว่ารายได้ส่วนใหญ่จะเกิดขึ้นในช่วงครึ่งปีหลัง ผ่านการจัดส่งผลิตภัณฑ์ภายใต้สัญญาที่มีอยู่ บริการด้านการพัฒนาภายใต้ข้อตกลงกับ Vericel โครงการอื่นที่ได้รับทุนสนับสนุนจากรัฐบาล และยอดขายเชิงพาณิชย์ของ NexoBrid ที่ดำเนินอยู่อย่างต่อเนื่อง

บริษัทระบุว่ากรอบเวลาของโรงงานผลิตในปัจจุบันคาดว่าจะไม่ส่งผลกระทบอย่างมีนัยสำคัญต่อคาดการณ์รายได้ปี 2026 ผู้บริหารยังคาดว่าค่าใช้จ่ายด้าน R&D จะยังคงอยู่ในระดับสูงเนื่องจากการทดลอง Phase III รายการ VALU รุดหน้าไป

ความเสี่ยงและประเด็นที่ต้องติดตาม

• คาดการณ์ตลอดทั้งปีขึ้นอยู่กับการเพิ่มขึ้นของรายได้ในช่วงครึ่งปีหลังอย่างมีนัยสำคัญจากการจัดส่งผลิตภัณฑ์ บริการด้านการพัฒนา และโครงการที่ได้รับทุนสนับสนุนจากรัฐบาล
• องค์ประกอบหลายประการของกรอบการทำงาน Vericel และ BARDA ยังคงต้องรอการหารือเพิ่มเติม ข้อคิดเห็นจาก FDA และข้อจำกัดด้านการรักษาความลับ
• เงินสด รายการเทียบเท่าเงินสด และเงินฝากลดลง 18 ล้านดอลลาร์ ในช่วงครึ่งปีแรก ขณะที่การใช้เงินสดแตะระดับ 20 ล้านดอลลาร์
• ผู้บริหารระบุว่า ยอดขาย NexoBrid ในปัจจุบันถูกจำกัดโดยกำลังการผลิตไม่ใช่ความต้องการ สินค้าคงคลังถูกอธิบายว่าหมดลงเกือบทั้งหมดในเขตพื้นที่ส่วนใหญ่และที่โรงงานของบริษัท
• การผลิตเชิงพาณิชย์จากโรงงานที่ขยายเพิ่มเติมยังคงขึ้นอยู่กับการยื่นเรื่อง การทบทวน การตรวจสอบ และการอนุมัติจากหน่วยงานกำกับดูแล
• MediWound ไม่ได้ให้ตัวเลขการลงทะเบียนหรือแนวโน้มสำหรับการทดลอง VALU โดยอ้างถึงความจำเป็นในการปกป้องความน่าเชื่อถือและความเที่ยงตรงของการศึกษา

ประเด็นสำคัญจากการถาม-ตอบกับนักวิเคราะห์

ผู้บริหารยืนยันว่าการทดลอง VALU ไม่จำเป็นต้องมีการปรับตัวดีขึ้นของแนวโน้มการลงทะเบียนในปัจจุบันเพื่อบรรลุเป้าหมายสำคัญในไตรมาส 1 ปี 2027

เกี่ยวกับคู่แข่งที่อาจเกิดขึ้นจาก SN-514 ซึ่งเป็นผู้สมัครขจัดเนื้อตายรุ่นที่สองของ Smith & Nephew นั้น MediWound กล่าวว่ายังไม่พบหลักฐานที่เผยแพร่ต่อสาธารณะว่าผลิตภัณฑ์ดังกล่าวได้เข้าสู่การพัฒนาทางคลินิกในผู้ป่วยแผลเรื้อรัง ผู้บริหารมองว่าสถานะ Phase III ของ EscharEx ถือเป็นผู้นำทางคลินิกอย่างมีนัยสำคัญ

ผู้บริหารกล่าวว่ามีแผนที่จะเข้าหารือกับ FDA หลังจากทราบผลการทดลอง VALU เพื่อกำหนดข้อกำหนดในการขออนุมัติสำหรับแผลเบาหวานที่เท้าและแผลกดทับ

เกี่ยวกับการผลิต NexoBrid ผู้บริหารกล่าวว่าคาดว่าการผลิตที่โรงงานที่ขยายเพิ่มเติมจะเริ่มขึ้นในต้นปี 2027 ก่อนการอนุมัติที่เป็นไปได้จาก EMA ในช่วงครึ่งปีหลัง ทั้งนี้คาดว่าข้อจำกัดด้านกำลังการผลิตจะคลี่คลายลงเมื่อได้รับการอนุมัติให้จัดส่งเชิงพาณิชย์

บริษัทระบุว่ายังไม่มีข้อมูลอัปเดตที่เผยแพร่ต่อสาธารณะเกี่ยวกับรหัส CPT Category I สำหรับ NexoBrid

บันทึกการประชุมผลประกอบการฉบับเต็ม

บทถอดเสียงฉบับเต็มของการประชุมทางโทรศัพท์ผลประกอบการ

คำชี้แจงจากฝ่ายบริหาร

Operator

Good day, and welcome to the MediWound Second Quarter 2026 Earnings Conference Call. [Operator Instructions] 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.

Gaia Shamis

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 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?

Ofer Gonen

Thank you, Gaia, and good morning, everyone. During the second quarter, we made meaningful progress against our strategic priorities, advancing EscharEx and [Technical Difficulty] Do you hear me?

Operator

Yes, we can hear you. Please stand by while we reconnect our speaker connected our speaker. [Audio Gap] Pardon everyone we reconnected our speaker. Please proceed.

Ofer Gonen

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 continue 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. Brown and MIMEDX. Together with the continued progress of the value 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 War with a total program budget of $18.3 million.

Together, these programs further expand NexoBrid growth, I'm here -- Together, this program further expands. 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 modification 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.

Hani Luxenburg

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 onetime 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 value 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 value 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.

Ofer Gonen

Thank you, Hani. The second quarter strengthened both our core growth platform. The value 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, the DOW funding, all 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 expectation 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 VLU 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?

Operator

[Operator Instructions] Our first question today comes from RK Ramakanth with H.C. Wainwright.

ช่วงถาม-ตอบ

Swayampakula Ramakanth

This is RK from H.C. Wainwright. Lots of stuff going on here. So, let's start off on the VLU study itself. On the study, do you still plan to get the study enrollment completed and get the interim also done during the early 2027? That's my first question.

The second one within that is very recently, Smith & Nephew on their call, they were talking about potentially working on a second-generation SANTYL. Not sure you folks are aware of it. And what do you think -- what's your business intelligence on that molecule? And how does that impact EscharEx development from here onwards?

Ofer Gonen

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 approach to potential competition from EscharEx, maybe, Barry, do you want to take this one?

Barry Wolfenson

Sure. Absolutely. RK. We heard those comments, and we found them interesting. I think the thing that's most notable about the comments were the context where he was talking a little bit about -- someone asked him about the competition. He was talking a little bit about his thoughts around EscharEx.

But then he said that they noted that sample is not a fast debridement option 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 or the drug, I should say, 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.

Swayampakula Ramakanth

So now based on those comments, does that mean that the market is bigger than what it is because SANTYL is obviously not the molecule of choice if it is not really doing what it is expected to do? And then the second part of that is on the -- your team has added treasure ulcers into the pool now. So how is that study being conducted in the sense, what is your responsibility within that IIT and would that data be available by the time you're ready to file your own application with the agencies, both in the U.S. and in the -- with the EMA?

Ofer Gonen

So Barry, maybe you will answer the first part of the question regarding Smith & Nephew and the market of pressure ulcer, and I'll speak about the study, okay?

Barry Wolfenson

Yes. Well, I think even more broadly, what I think I heard you ask, RK, is does that mean that since SANTYL is not particularly effective and that Smith & Nephew is motivated to create a new drug, this must -- the inference is that the market is even bigger than what SANTYL is currently supplying.

And we believe the answer to that is resoundingly yes. That's why as we -- even before including pressure ulcers, we showed our peak sales in the $800 million range. And with including pressure ulcers, it tops $1 billion. We believe that a drug for debridement that can reach complete debridement, certainly within four to five days changes the entire expectation with regard to enzymatic debridement. It fits better into the workflows of wound clinics and podiatry offices and it takes away because of that share -- utilization share, not just from sharp debridement, but across all different modalities. So, we do believe that it greatly expands the market.

Ofer Gonen

So, if we speak about the pressure ulcer study, so it's important to mention that the Phase III VLU study in VLU -- this is the primary focus of EscharEx development program. It's, of course, the company's key value driver. The pressure ulcer study is an investigator initiated. So, it's not run directly by us. It's a small study, open-label trial, 10, 15 patients, and the initiation is expected in the fourth quarter of 2026. It enrolls, of course, pressure ulcer patients.

All of them are treated with EscharEx across a week or 2. And we are assessing as usually debridement, granulation and wound closure. Following this -- the value readout, we plan to approach with the FDA and determine what would be required to pursue approvals also for DFU and pressure ulcers.

Swayampakula Ramakanth

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 time lines are moving back. So, is that true in your sense of the world?

And also, if things get pushed to fourth quarter of '27, does that mean the real product for the market actually gets pushed into 2028? And the third part of the questions are on the CPT code, where do we stand? And is January 2027 still an effective and realistic date?

Ofer Gonen

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. And 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?

Barry Wolfenson

To my knowledge, there is no publicly available information regarding any update on a -- to a Category 1 CPT code.

Operator

The next question comes from Josh Jennings with TD Cowen.

Joshua Jennings

And Barry. I wanted to just touch on the updated MSA with Vericel. Can you just -- any additional details you can share just on the changes to revenue recognition? Is the major update that you'll be -- the recognizing of revenue for the development program that's been expanded for blast and friction injuries and potentially extending the shelf life of NexoBrid. And then the second question is just on the -- any updates to the path for the DFU indication in the clinical development program there.

Ofer Gonen

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. It's a multiyear framework agreement with several components.

So, 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, pain friction injuries is underway, and Vericel expects about $6 million of BARDA procurement revenue in the second half. Additional elements, including the room temperature stable formulation, the U.S.-based manufacturing readiness, -- these 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.

If this is good enough, I'm moving to the DFU? Okay. So, regarding the DFU, we have constructive discussions with the FDA and EMA. We got feedback. We are aligned on a DFU protocol. You can see the highlight of the protocol. It is attached to our corporate deck. And 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. And the primary endpoint is something that EscharEx is very good at time to complete debridement -- so we see it as a trial, which is not that complicated. As I said to the previous question that I asked by RK, we plan to approach the FDA after the value readout and then to determine what would be required to pursue approval for that indication as well.

Operator

The next question comes from Jeff Jones with Oppenheimer.

Jeffrey Jones

One point of clarification on the BARDA contract with Vericel. You noted that Vericel 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 on negotiation? And then in regards to NexoBrid, looking ahead into '26 and '27, how do we think about revenue given the facility now doesn't look to be coming online until 2H '27?

Ofer Gonen

Okay. Jeff, good to have you on. So as for the first question, you gave there a number that I'm not familiar with, which is the 14. The 14 is not exclusively by BARDA. We have additional government-related agreements, one of them you are familiar with, which is the Department of War. So, expect some news there as well. The agreement with -- the MSA agreement with BARDA includes a few components.

As I said, I cannot give you at this stage, used to confidentiality obligations, I cannot give you all the components. Having said that, the first program, which is development of blast and friction burn indication is on its way. Additional components are currently discussed and negotiated.

As for the procurement, -- we -- MediWound expects to benefit from the procurement that BARDA is -- has with Vericel. It's not one-to-one. We have the transfer prices with Vericel. Nothing really is disclosed at this stage. But when you speak about the amount of development services, BARDA agreement, it contains a few components and not only one.

Jeffrey Jones

Great.

Ofer Gonen

This is the first sentence -- first question. As for the second question, Hani, do you want to address the manufacturing facility delay?

Hani Luxenburg

Yes. Jeff, we do not actually expect the current facility timeline to have 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 being depending on commercial supply from our expanded facility. So, our $24 million to $26 million in 2026 revenue guidance already reflects the current status and the expected timing of our facility.

Ofer Gonen

And as you asked also about '27 and '28, as I mentioned earlier about the facility readiness, we -- our plan is to finish all the modification by the end of the fourth quarter of this year. And first thing that we are going to do next year is to start manufacturing NexoBrid. So we don't think we have -- there will be any impact at all to the expected revenue in '27 and '28 for NexoBrid.

Operator

The next question comes from Chase Knickerbocker with Craig-Hallum.

Chase Knickerbocker

Maybe just on a little bit more specifics about value. Can you just talk about how the enrollment rate has trended sequentially on like a per site basis? And then can you just confirm that kind of all those 40 sites are up running and enrolling? And then just as we think about what your expectation for the 1Q resampling is, are you assuming any improvement in enrollment trends in that assumption? Or is it just kind of static?

Ofer Gonen

Chase, good to have you with us. As for the value, let's speak about the numbers 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 snapshot 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 can I 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. I hope I answered the first question, right?

Chase Knickerbocker

Yes. And maybe you can -- I mean, you've spoken to kind of active sites in the past. Can you maybe just speak to kind of the update there? -- Go ahead.

Ofer Gonen

Regarding the sites, as we said, we are targeting approximately 40 sites, and we are something like very close to have them all recruiting. It's -- we have more -- less than 10% to reach this target.

Chase Knickerbocker

Got it. And then maybe just as we think about -- you obviously are also guiding to full enrollment, but if we just think about top line data kind of post last patient enrolled, I mean, should we think about it as kind of 12 weeks, obviously, to that wound healing follow-up and then kind of a month or two for data lock and the like? Or maybe just talk us through exactly how that time line will work?

And then lastly, just one for Barry. So, we're seeing a pretty large volume shift in wound care from Site 11 to Site 22. Can you just remind us the sites of service that you think EscharEx will predominantly be used in if approved? And then if you could just remind us again where kind of SANTYL usage is concentrated today and how you expect that to kind of change from a mix perspective for EscharEx?

Ofer Gonen

So, Barry, let me start with answering about the clinical trial, if this is okay. Well, you got it quite accurately, Chase. 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 top line data. And after the top line data, it is another few months until the final results.

As for EscharEx, Barry, do you want to address it?

Barry Wolfenson

Sure. Most of that shifting, of course, Chase, has to do with the CMS change to how it reimburses the tissue substitute products. Based on the third-party data that we've acquired regarding prescriptions of SANTYL, it's fairly well distributed across acute care into clinics, into home health and certainly into nursing homes and SNFs. And we don't see that materially changing nor do we see that being any different for EscharEx.

Operator

The next question comes from Michael Okunewitch with Maxim Group.

Michael Okunewitch

So, I just -- I wanted to follow up on the question surrounding the '27 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?

Ofer Gonen

Michael, this is a good question. So, as I said, we are actually manufacturing the NexoBrid in the beginning of 2027. Everything is ready to be shipped. The demand is there. Second half of 2027, we can sell significantly more than we are selling now. Currently, as you know, our ability to sell is capped by manufacturing capabilities. And in 2027, this limitation will finally be removed.

Michael Okunewitch

All right. And then what is the delay on the EMA side effect FDA? Is that still one half after EMA approval? Or would these now be contemporaneous?

Ofer Gonen

Mathematically, it's something like three months. Having said that, the most important milestone is getting the first approval. As I mentioned in the previous call, and I'm sure that you remember, EMA comes first. And once EMA come first, we can start selling substantially most of the inventory to the European countries. And then the current facility can be dedicated to sell to the U.S. market and to stockpile for governments.

So, this is the more important milestone. So, this is why we are speaking about the first regulatory approval. If FDA happens three months after that or five months after that depends on inspections and other things, I don't think it will really change anything for a revenue point of view.

Michael Okunewitch

And then one last one for me before I hop back into the queue. 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 the full BARDA contract up and running. So, 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?

Ofer Gonen

So yes, you're right. We are reaffirming the $24 million to $26 million revenue guidance for 2026. Since the revenue for the first half was $4.6 million. Clearly, the majority of the year -- it is weighted towards the second half of the year. We expect meaningful step-up in H2, driven by the product supply related to the contracts, development services under the Vericel MSA and other government-funded programs, including the Department of War and of course, the ongoing commercial NexoBrid sale.

Under the MSA, we just announced that we initiated the first development program to support the expansion to last injuries. But we -- as I mentioned, we expect to initiate additional development programs under the MSA in the near term as well.

Operator

The next question comes from Scott Henry with Alliance Global Partners.

Scott Henry

Most of my questions have been asked, but I did want to follow up on the product sales for 2026. Obviously, the $2.6 million was very strong in 2Q, but first quarter was only $528,000 based on what I got out of the filings. Would it be better to think about capacity for product sales as kind of the combination of those 2, 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 this capacity? Is that how I should be thinking about it? Or could you duplicate $2.6 million again prior to the capacity expansion?

Ofer Gonen

Scott, as you know, we are not guiding specifically for product, but I don't think it will be the right thing to do is to think that we sold everything that we could. Again, we are capped only by capacity, not by demand. The inventory of NexoBrid is currently zero, I think, in most territories and definitely here in the facility.

Some of the impacts that we -- that you saw that prevented us from to generate more revenue were because of the fact that the facility itself needed to go through all kind of inspections and all kind of upgrades, et cetera. So, I think it would be more accurate to look at the second quarter. Having said that, I would look at last year, and we are selling everything that we have. So maybe last year, if you add, let's say, 10% premium because of price changes and a little bit more effectiveness, I think it will be more accurate.

Scott Henry

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 '26. How should we think about the next couple of quarters there?

Ofer Gonen

Scott, the increase in R&D is, as you know, primarily driven by our VALUE Phase III trial, which remain our top strategic priority in the company. We are not providing quarterly R&D, but we -- guidance, but we currently at an elevated level of investment and expect R&D spending to remain elevated as value progresses through this phase of our program.

At the same time, a meaningful portion of our NexoBrid development activity is supported, as you know, by nondilutive government funding through BARDA and through the Department of War. So, while we are investing significantly in value, we are also being very disciplined about where we deploy our own capital. I hope I answered your question.

Operator

This concludes our question-and-answer session. I would like to turn the conference back over to Ofer Gonen for any closing remarks.

Ofer Gonen

So thank you, everyone, for joining us today. We look forward to updating you again on our next quarterly call.

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.