NexoBrid® interest surges; $5 million in Q1 2024 revenue, with $24 million forecast for the year Manufacturing facility on target for completion by mid-2024 EscharEx® Phase III study to launch 2H 2024 Company set to join Russell 3000® Index Conference call today, May 29 at 8:30am Eastern Time YAVNE, Israel, May 29, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the first quarter ende ...

YAVNE, Israel, May 22, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the Company will release its financial results for the first quarter ended March 31, 2024 on Wednesday, May 29, 2024. Following the release, management will host a conference call and live webcast at 8:30 am Eastern Time to discuss the financial results, provide corporate updates, and answer questions. MediWound Contacts: | Hani Lu ...

MediWound (MDWD) shares soared 14.3% in the last trading session to close at $18.28. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 1.7% gain over the past four weeks.Last month, the company announced robust financial results for the full year and fourth quarter ended 2023. This might have been driving the share price rally.This developer of treatments for burns and hard-to-heal wounds is expected to post quarterly loss of $0.40 ...

Company Highlights 14 successful clinical trials 120+ peer-reviewed publications Key approvals: FDA/EMA/JPN Significant commercial growth potential | --- | --- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR 12(g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________________ to ____________________ OR ☐ SHELL COMPANY REPORT P ...

Revenue and Profitability - Revenue for 2023 was $19 million, with projected revenue of $24 million for 2024[1] - Total revenues for the twelve months ended December 31, 2023, decreased to $18.686 million from $26.496 million in 2022, representing a decline of approximately 29.9%[27] - Gross profit for the twelve months ended December 31, 2023, was $3.578 million, down from $13.165 million in 2022, indicating a decrease of about 72.8%[27] - Gross profit for Q4 2023 was $0.7 million, representing 13.5% of total revenue, down from 70.2% in Q4 2022[9] - Adjusted EBITDA for the year ended December 31, 2023, was a loss of $12.3 million, compared to a loss of $4.4 million in 2022[9] - Adjusted EBITDA for the twelve months ended December 31, 2023, was $(12.258) million, compared to $(4.443) million in 2022, indicating a decline of approximately 175.2%[33] Losses and Financial Position - Operating loss for the year ended December 31, 2023, was $15.3 million, compared to an $8.3 million loss in 2022[9] - The company reported an operating loss of $15.290 million for the twelve months ended December 31, 2023, compared to an operating loss of $8.345 million in 2022, indicating a worsening of approximately 83.5%[27] - Net loss for the year ended December 31, 2023, was $6.7 million, or $0.75 per share, compared to a net loss of $19.6 million, or $3.93 per share in 2022[9] - The net loss for the twelve months ended December 31, 2023, was $6.716 million, compared to a net loss of $19.599 million in 2022, reflecting an improvement of approximately 65.7%[27] - Cash and cash equivalents at the end of the period decreased to $11.866 million from $33.895 million at the end of 2022, a decline of about 65.0%[31] - Net cash used in operating activities for the twelve months ended December 31, 2023, was $10.465 million, compared to $11.885 million in 2022, a decrease of approximately 11.9%[29] Assets and Investments - Cash, restricted cash, and investments as of December 31, 2023, totaled $42.1 million, up from $34.1 million in 2022[10] - Total assets increased to $66.459 million as of December 31, 2023, from $50.016 million in 2022, representing a growth of approximately 32.7%[25] Research and Development - The company received $13 million in R&D funding from the U.S. Department of Defense for a new NexoBrid formulation[6] - Research and development expenses for the twelve months ended December 31, 2023, were $7.467 million, down from $10.181 million in 2022, a decrease of about 26.7%[27] - The Phase III study for EscharEx® is set to begin in the second half of 2024, with 216 patients to be treated globally[6] Manufacturing and Capacity - NexoBrid® was commercially launched in the U.S., Japan, and India, contributing to the revenue growth[3] - A new GMP-compliant manufacturing facility is projected to achieve a 6-fold increase in manufacturing capacity by 2025[3] Shareholder Information - The weighted average number of ordinary shares increased to 9,013,144 for the twelve months ended December 31, 2023, compared to 4,987,069 in 2022, an increase of about 80.6%[27]

Financial Data and Key Metrics Changes - The company's revenue for the first nine months of 2023 totaled $13.3 million, a decrease from $14.9 million in the same period of 2022 [3] - The operating loss for this period was $11.4 million, compared to an operating loss of $10.5 million recorded in the same period last year [3] - The net loss for the first nine months was $5 million or $0.56 per share, which is a significant improvement from a net loss of $12.1 million or $2.67 per share for the first nine months of 2022 [3] - The non-GAAP adjusted EBITDA showed a loss of $9 million, compared to a loss of $7.9 million reported in the first nine months of 2022 [3] - As of September 30, 2023, the company's cash, restricted cash, and investments were at $46 million, an increase from $34.1 million reported on December 31, 2022 [19] Business Line Data and Key Metrics Changes - NexoBrid was successfully launched in the United States and Japan, with positive initial feedback from the Japanese market [25][40] - The CHMP recommended NexoBrid label extension to include pediatric indications, significantly increasing its addressable market [25] - The company reported revenue of $4.8 million for the third quarter, a decrease from $5.8 million in the same quarter of the previous year [49] - Gross profit for the quarter stood at $0.9 million or 19% of total revenues compared to $2.4 million or 41.9% of total revenue in the third quarter of 2022 [49] Market Data and Key Metrics Changes - The Japanese market for NexoBrid is substantial, with over 6,000 patients annually receiving treatment for severe burns [5] - The global demand for NexoBrid has risen, fueled by geopolitical conflicts and governmental actions [38][42] - The company anticipates a substantial increase in NexoBrid's revenue following the completion of its scale-up [12] Company Strategy and Development Direction - The company is focused on expanding operational capabilities to meet rising global demand for NexoBrid [30] - The construction of a new GMP-compliant facility is on schedule for completion by mid-2024, with full-scale manufacturing capabilities expected in 2025 [30][69] - The company aims to maintain its manufacturing targets and expand production capabilities to address surging demand [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for NexoBrid's global revenue growth, driven by commercial launches and rising governmental interests [11] - The company is committed to addressing the current demand for NexoBrid, which exceeds its manufacturing capacity [64] - Management highlighted the importance of the upcoming Phase III study for EscharEx, with enrollment expected to begin in the second half of 2024 [39] Other Important Information - The company secured a $6.5 million R&D budget from the Department of Defense to advance the development of a new temperature-stable formulation for NexoBrid [43] - The company has received guidance from both the FDA and EMA on the protocol for the global Phase III study of EscharEx [45] Q&A Session Summary Question: Can you expand on the commercialization of NexoBrid in Japan? - Management noted that initial feedback from Kaken Pharmaceutical is positive, and they are working to secure contracts in key hospital systems [5] Question: What is the timeline for the EscharEx trial and interim assessment? - Management indicated that the interim assessment is planned after 67% of patients have completed the trial, with a focus on efficacy data [70] Question: How does the manufacturing scale-up impact profitability? - Management stated that the scale-up is expected to generate meaningful revenue in 2025, with profitability anticipated in 2026 or 2027 [74]

[MediWound Third Quarter 2023 Financial Results and Company Update](index=1&type=section&id=MediWound%20Third%20Quarter%202023%20Financial%20Results%20and%20Company%20Update) [Company Overview and CEO Remarks](index=1&type=section&id=Company%20Overview%20and%20CEO%20Remarks) In Q3 2023, MediWound achieved significant milestones, including the successful commercial launch of NexoBrid® in the U.S. and Japan, while maintaining a strong cash position of $46 million - Successfully launched NexoBrid® in two key markets, the U.S. and Japan, enhancing the company's global footprint[3](index=3&type=chunk) - Global conflicts have escalated demand for NexoBrid®, leading the company to prioritize resources to meet this increase, with the U.S. Department of Defense funding a field-care burn treatment[4](index=4&type=chunk) - Preparations for the EscharEx® Phase III study are advancing, with protocol submission to the FDA expected in Q1 2024 and enrollment to begin in H2 2024, alongside a new collaboration with 3M Healthcare[5](index=5&type=chunk) - The company reported a cash position of **$46 million**, with an operating cash runway expected to last through profitability[1](index=1&type=chunk) [Third Quarter 2023 Highlights and Recent Developments](index=2&type=section&id=Third%20Quarter%202023%20Highlights%20and%20Recent%20Developments) This section details specific operational achievements for NexoBrid® and EscharEx®, alongside corporate management updates, including commercial launches and progress on clinical trials [NexoBrid®](index=2&type=section&id=NexoBrid%C2%AE) NexoBrid® saw major commercial launches in the U.S. and Japan, expanded its European presence, and received increased demand and funding due to global conflicts and military needs - Announced commercial availability of NexoBrid® in the U.S. with partner Vericel Corporation and in Japan with partner Kaken Pharmaceutical Co[8](index=8&type=chunk) - Deployed all available non-U.S. inventory to treat mass burn casualties from the war in Israel and is reallocating resources to scale up manufacturing to meet surging global demand[8](index=8&type=chunk) - Secured a **$6.5 million** R&D budget from the U.S. Department of Defense to develop a new, temperature-stable formulation of NexoBrid® for the U.S. Army[8](index=8&type=chunk) - Expanded European market presence through a collaboration with PolyMedics Innovations (PMI) for promotion in Germany, Austria, and the Benelux countries[8](index=8&type=chunk) [EscharEx®](index=2&type=section&id=EscharEx%C2%AE) Preparations for the global Phase III trial are advancing, with protocol submission to the FDA expected in Q1 2024 and patient enrollment in H2 2024, supported by a new R&D partnership with 3M Healthcare - An updated Phase III protocol will be submitted in Q1 2024, with patient enrollment expected to commence in H2 2024[8](index=8&type=chunk) - The global Phase III trial will enroll approximately **216 patients**, with co-primary endpoints of complete debridement and wound closure, and an interim assessment planned after 67% of participants complete the trial[8](index=8&type=chunk) - Established a research and development partnership with 3M Healthcare to support the EscharEx Phase III clinical study[8](index=8&type=chunk) [Corporate Development](index=3&type=section&id=Corporate%20Development) MediWound appointed Dr. Shmulik Hess as the new Chief Operating Officer and Chief Commercial Officer, effective December 1, 2023, to strengthen its operational and commercial capabilities - Appointed Shmulik Hess, Ph.D. as Chief Operating Officer and Chief Commercial Officer, effective December 1, 2023, to fortify the company's global operations and commercial activities[11](index=11&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) The company reported Q3 2023 revenues of $4.8 million, a decrease from the prior year, but a significantly narrowed net loss of $2.2 million, supported by a strong cash position of $46 million [Third Quarter 2023 Financial Highlights](index=3&type=section&id=Third%20Quarter%202023%20Financial%20Highlights) Q3 2023 revenues were $4.8 million, down from $5.8 million in Q3 2022, primarily due to the absence of nonrecurring BARDA income, while net loss improved to $2.2 million Q3 2023 Financial Results (in millions of USD, except per share data) | Metric | Q3 2023 | Q3 2022 | Change | | :--- | :--- | :--- | :--- | | Revenues | $4.8 | $5.8 | -17.2% | | Gross Profit | $0.9 | $2.4 | -62.5% | | Operating Loss | ($3.0) | ($3.5) | Improved | | Net Loss | ($2.2) | ($4.2) | Improved | | Net Loss Per Share | ($0.24) | ($0.88) | Improved | | Adjusted EBITDA | ($2.6) | ($2.5) | Widened | [Year-to-Date 2023 Financial Highlights](index=4&type=section&id=Year-to-Date%202023%20Financial%20Highlights) For the first nine months of 2023, revenues were $13.3 million, a decrease from $14.9 million in the prior year, with the net loss significantly decreasing to $5.0 million from $12.1 million Nine Months Ended Sep 30, 2023 Financial Results (in millions of USD, except per share data) | Metric | YTD 2023 | YTD 2022 | Change | | :--- | :--- | :--- | :--- | | Revenues | $13.3 | $14.9 | -10.7% | | Operating Loss | ($11.4) | ($10.5) | Widened | | Net Loss | ($5.0) | ($12.1) | Improved | | Net Loss Per Share | ($0.56) | ($2.67) | Improved | | Adjusted EBITDA | ($9.0) | ($7.9) | Widened | [Balance Sheet Overview](index=4&type=section&id=Balance%20Sheet%20Overview) As of September 30, 2023, the company held **$46 million** in cash, restricted cash, and investments, an increase from **$34.1 million** at year-end 2022, bolstered by a **$27.5 million** offering - Cash, restricted cash, and investments totaled **$46 million** as of September 30, 2023, compared to **$34.1 million** as of December 31, 2022[13](index=13&type=chunk) - The company raised a gross amount of **$27.5 million** in Q1 2023 through a registered direct offering[13](index=13&type=chunk) - Existing cash and cash equivalents are expected to provide sufficient funds for the company's current operating plan through profitability[13](index=13&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) This section provides the detailed, unaudited condensed interim consolidated financial statements for the period ended September 30, 2023, including the Balance Sheet, Income Statement, Cash Flows, and Adjusted EBITDA reconciliation [Consolidated Statements of Financial Position](index=7&type=section&id=Unaudited%20Condensed%20Interim%20Consolidated%20Statements%20of%20Financial%20Position) The balance sheet as of September 30, 2023, shows total assets of **$67.0 million**, primarily driven by **$45.5 million** in cash and short-term deposits, with total shareholders' equity of **$33.1 million** Key Balance Sheet Items (in thousands of USD) | Account | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $9,279 | $33,895 | | Short-term bank deposits | $36,244 | - | | **Total Assets** | **$67,017** | **$50,016** | | **Total Liabilities** | **$33,967** | **$39,102** | | **Total Shareholders' Equity** | **$33,050** | **$10,914** | [Consolidated Statements of Profit or Loss](index=8&type=section&id=Unaudited%20Condensed%20Interim%20Consolidated%20Statements%20of%20Profit%20or%20Loss) The income statement for Q3 2023 details revenues of **$4.8 million** and a net loss of **$2.2 million**, with year-to-date revenues of **$13.3 million** and a net loss of **$5.0 million** Key Income Statement Items (in thousands of USD) | Metric | Q3 2023 | Q3 2022 | YTD 2023 | YTD 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $4,776 | $5,803 | $13,348 | $14,878 | | Gross Profit | $896 | $2,434 | $2,859 | $5,007 | | Operating Loss | ($3,025) | ($3,510) | ($11,396) | ($10,468) | | Net Loss | ($2,196) | ($4,199) | ($4,973) | ($12,142) | [Consolidated Statements of Cash Flows](index=9&type=section&id=Unaudited%20Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2023, net cash used in operating activities was **$7.9 million**, with **$39.3 million** used in investing activities and **$23.1 million** provided by financing activities Cash Flow Summary - Nine Months Ended Sep 30, 2023 (in thousands of USD) | Activity | YTD 2023 | YTD 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($7,850) | ($13,885) | | Net cash used in investing activities | ($39,349) | ($2,877) | | Net cash provided by financing activities | $23,121 | $21,126 | [Adjusted EBITDA Reconciliation](index=10&type=section&id=Adjusted%20EBITDA) The company reported a non-IFRS Adjusted EBITDA loss of **$2.6 million** for Q3 2023, a slight increase from the **$2.5 million** loss in Q3 2022, with a year-to-date loss of **$9.0 million** Adjusted EBITDA (in thousands of USD) | Period | Net Loss | Adjustments | Adjusted EBITDA | | :--- | :--- | :--- | :--- | | **Q3 2023** | ($2,196) | $403 | **($2,599)** | | **Q3 2022** | ($4,199) | ($1,734) | **($2,465)** | | **YTD 2023** | ($4,973) | $4,048 | **($9,021)** | | **YTD 2022** | ($12,142) | ($4,275) | **($7,867)** | [Additional Information](index=4&type=section&id=Additional%20Information) This section contains details about the investor conference call, a description of the company's business and product pipeline, and the standard cautionary note regarding forward-looking statements [Conference Call Information](index=4&type=section&id=Conference%20Call) MediWound management hosted an investor conference call on Tuesday, November 21, 2023, at 8:30 a.m. Eastern Time to discuss financial results and provide a corporate update - A conference call for investors was scheduled for Tuesday, November 21, 2023, at 8:30 a.m. Eastern Time[14](index=14&type=chunk) [About MediWound](index=5&type=section&id=About%20MediWound) MediWound is a global leader in enzymatic therapeutics for non-surgical tissue repair, with key products including NexoBrid® for severe burns and EscharEx® (Phase III) for chronic wounds - MediWound focuses on non-surgical tissue repair using enzymatic therapeutics[20](index=20&type=chunk) - Key products include NexoBrid® for severe burns, EscharEx® (Phase III) for chronic wounds, and MW005 for basal cell carcinoma (Phase I/II completed)[21](index=21&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section provides a standard safe harbor statement, cautioning that the press release contains forward-looking statements concerning product development, timelines, and commercial potential - The press release contains forward-looking statements regarding the progress, timelines, and commercial potential of products like EscharEx® and NexoBrid®[23](index=23&type=chunk)[24](index=24&type=chunk) - Actual results may differ due to inherent uncertainties in product development, regulatory approvals, market acceptance, and other factors detailed in SEC filings[24](index=24&type=chunk)[25](index=25&type=chunk)

[Unaudited Condensed Interim Consolidated Statements of Financial Position](index=2&type=section&id=Unaudited%20Condensed%20Interim%20Consolidated%20Statements%20of%20Financial%20Position) [Financial Position Overview](index=2&type=section&id=Financial%20Position%20Overview) The company's financial position improved significantly as of June 30, 2023, with substantial growth in total assets and a reversal of the prior year's shareholders' deficit Key Financial Position Indicators (USD in thousands) | Indicator | June 30, 2023 | December 31, 2022 | June 30, 2022 | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | 19,166 | 33,895 | 7,729 | | Short-term bank deposits | 31,956 | - | 2,509 | | Trade receivables | 3,228 | 9,332 | 3,759 | | Inventories | 3,113 | 1,963 | 1,991 | | Total current assets | 58,053 | 45,840 | 16,809 | | Total assets | 64,366 | 50,016 | 21,106 | | Total current liabilities | 8,309 | 12,057 | 10,416 | | Warrants liability | 9,683 | 15,606 | - | | Total liabilities | 29,437 | 39,102 | 23,341 | | Additional paid-in capital | 205,642 | 178,882 | 154,119 | | Accumulated deficit | (170,883) | (168,106) | (156,450) | | Shareholders' equity (deficit) | 34,929 | 10,914 | (2,235) | - As of June 30, 2023, the company's cash and cash equivalents were **$19,166 thousand**, a decrease from $33,895 thousand on December 31, 2022, while short-term bank deposits increased from zero to **$31,956 thousand**, indicating a shift in liquidity allocation strategy[3](index=3&type=chunk) - Total assets grew by approximately **28.7%** to **$64,366 thousand** as of June 30, 2023, from $50,016 thousand on December 31, 2022[3](index=3&type=chunk) - Shareholders' equity surged by approximately **220%** to **$34,929 thousand** as of June 30, 2023, from $10,914 thousand on December 31, 2022, primarily due to an increase in additional paid-in capital[3](index=3&type=chunk) [Unaudited Condensed Interim Consolidated Statements of Profit or Loss and Other Comprehensive Income or Loss](index=3&type=section&id=Unaudited%20Condensed%20Interim%20Consolidated%20Statements%20of%20Profit%20or%20Loss%20and%20Other%20Comprehensive%20Income%20or%20Loss) [Profit or Loss Overview](index=3&type=section&id=Profit%20or%20Loss%20Overview) The company's net loss narrowed significantly for the six months ended June 30, 2023, driven by a substantial increase in financial income despite a slight revenue decline Key Profit or Loss Indicators (USD in thousands) | Indicator | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Revenues from product sales | 2,358 | 2,771 | 1,206 | 1,669 | | Revenues from development services | 6,149 | 5,866 | 3,534 | 2,777 | | Revenues from license agreements | 65 | 438 | 33 | 222 | | **Total revenues** | **8,572** | **9,075** | **4,773** | **4,668** | | Cost of product sales | 1,436 | 1,539 | 628 | 1,148 | | Cost of development services | 5,170 | 4,932 | 3,005 | 2,391 | | Cost of license agreements | 3 | 31 | 3 | 16 | | **Total cost of revenues** | **6,609** | **6,502** | **3,636** | **3,555** | | **Gross profit** | **1,963** | **2,573** | **1,137** | **1,113** | | Research and development expenses | 4,126 | 4,599 | 2,024 | 2,191 | | Selling and marketing expenses | 2,438 | 1,854 | 1,332 | 935 | | General and administrative expenses | 3,770 | 2,769 | 1,788 | 1,352 | | **Total operating expenses** | **10,334** | **9,531** | **5,144** | **4,787** | | **Operating loss** | **(8,371)** | **(6,958)** | **(4,007)** | **(3,674)** | | Financial income | 7,480 | 11 | 5,828 | 11 | | Financial expenses | (1,869) | (988) | (893) | (687) | | **Net financial income (expenses)** | **5,611** | **(977)** | **4,935** | **(676)** | | **Profit (loss) before taxes** | **(2,760)** | **(7,935)** | **928** | **(4,350)** | | **Net profit (loss)** | **(2,777)** | **(7,943)** | **916** | **(4,354)** | | Basic and diluted net profit (loss) per share - USD | (0.32) | (1.79) | 0.10 | (0.92) | - For the six months ended June 30, 2023, total revenues were **$8,572 thousand**, a **5.5% decrease** from $9,075 thousand in the prior-year period, with product sales and license agreement revenues declining by 15% and 85% respectively, while development services revenue grew by 4.8%[4](index=4&type=chunk) - The net loss for the six months ended June 30, 2023, narrowed significantly to **$2,777 thousand** from $7,943 thousand in the prior-year period, primarily due to net financial income of **$5,611 thousand** compared to a net expense of ($977) thousand previously[4](index=4&type=chunk) - For the three months ended June 30, 2023, the company reported a **net profit of $916 thousand**, a significant turnaround from a net loss of $4,354 thousand in the same period last year, with earnings per share improving from ($0.92) to **$0.10**[4](index=4&type=chunk) [Unaudited Condensed Interim Consolidated Statements of Changes in Shareholders' Equity (Deficit)](index=4&type=section&id=Unaudited%20Condensed%20Interim%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Equity%20(Deficit)) [Shareholders' Equity Changes](index=4&type=section&id=Shareholders'%20Equity%20Changes) Shareholders' equity increased substantially as of June 30, 2023, primarily driven by a public offering of ordinary shares and share-based compensation Overview of Changes in Shareholders' Equity (USD in thousands) | Indicator | June 30, 2023 | December 31, 2022 | June 30, 2022 | | :--- | :--- | :--- | :--- | | Share capital | 184 | 143 | 93 | | Additional paid-in capital | 205,642 | 178,882 | 154,119 | | Foreign currency translation reserve | (14) | (5) | 3 | | Accumulated deficit | (170,883) | (168,106) | (156,450) | | **Total equity (deficit)** | **34,929** | **10,914** | **(2,235)** | Key Changes (December 31, 2022 to June 30, 2023) | Change Item | Amount (USD in thousands) | | :--- | :--- | | Balance as of December 31, 2022 | 10,914 | | Loss for the period | (2,777) | | Other comprehensive loss | (9) | | Issuance of ordinary shares (net of issuance costs) | 25,469 | | Share-based compensation | 1,331 | | Balance as of June 30, 2023 | 34,929 | - As of June 30, 2023, the company's shareholders' equity was **$34,929 thousand**, an increase of **$24,015 thousand** from $10,914 thousand on December 31, 2022[3](index=3&type=chunk)[5](index=5&type=chunk)[8](index=8&type=chunk) - Additional paid-in capital increased from $178,882 thousand on December 31, 2022, to **$205,642 thousand** on June 30, 2023, mainly due to the issuance of ordinary shares and share-based compensation[3](index=3&type=chunk)[5](index=5&type=chunk)[8](index=8&type=chunk) - The accumulated deficit increased from ($168,106) thousand on December 31, 2022, to **($170,883) thousand** on June 30, 2023, reflecting the net loss for the period[3](index=3&type=chunk)[5](index=5&type=chunk)[8](index=8&type=chunk) [Unaudited Condensed Interim Consolidated Statements of Cash Flows](index=6&type=section&id=Unaudited%20Condensed%20Interim%20Consolidated%20Statements%20of%20Cash%20Flows) [Cash Flows Overview](index=6&type=section&id=Cash%20Flows%20Overview) For the six months ended June 30, 2023, net proceeds from financing activities offset increased investing outflows, while operating cash outflow improved Key Cash Flow Indicators (USD in thousands) | Indicator | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Net cash from operating activities | (4,599) | (9,319) | (5,251) | (5,254) | | Net cash from investing activities | (33,521) | (2,797) | (26,078) | (2,637) | | Net cash from financing activities | 23,848 | 9,349 | (405) | (728) | | Effect of exchange rate changes | (457) | (550) | (120) | (303) | | Increase (decrease) in cash and cash equivalents | (14,729) | (3,317) | (31,854) | (8,922) | | Cash and cash equivalents at end of period | 19,166 | 7,729 | 19,166 | 7,729 | - For the six months ended June 30, 2023, net cash used in operating activities was **$4,599 thousand**, an improvement compared to $9,319 thousand in the prior-year period[11](index=11&type=chunk) - Net cash used in investing activities for the six months ended June 30, 2023, increased significantly to **$33,521 thousand**, primarily due to a **$31,830 thousand** investment in short-term bank deposits and **$2,570 thousand** for the purchase of property and equipment[13](index=13&type=chunk) - Net cash provided by financing activities for the six months ended June 30, 2023, was **$23,848 thousand**, a substantial increase from $9,349 thousand in the prior-year period, mainly driven by **$24,909 thousand** in net proceeds from the issuance of shares and warrants[13](index=13&type=chunk) [Notes to Unaudited Condensed Interim Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Interim%20Consolidated%20Financial%20Statements) [Note 1: General](index=8&type=section&id=Note%201%3A%20General) This note details the company's operations, product commercialization, government contracts, and a recent product launch delay in the U.S [Note 1a: Description of the Company and its operations](index=8&type=section&id=Note%201a%3A%20Description%20of%20the%20Company%20and%20its%20operations) - MediWound Ltd is a biopharmaceutical company focused on developing, manufacturing, and commercializing novel, cost-effective biotherapeutic non-surgical solutions for tissue repair and regeneration[15](index=15&type=chunk) - The company's primary product, NexoBrid, received U.S. FDA approval in December 2022 and marketing authorizations in India, Switzerland, and Japan for the removal of eschar in patients with deep partial and full-thickness thermal burns[16](index=16&type=chunk) - NexoBrid is commercialized in the EU, UK, and Israel through the company's commercial organization and in various international markets via local distribution channels[17](index=17&type=chunk)[20](index=20&type=chunk) - The company is developing a second product, EscharEx, for the treatment of chronic and other hard-to-heal wounds, and is currently in discussions with the FDA regarding the design of a pivotal Phase III study[18](index=18&type=chunk) - A third clinical-stage product, MW005, is a topical biologic drug for non-melanoma skin cancers; its Phase I/II study initiated in July 2021 reported positive final results in December 2022[19](index=19&type=chunk) [Note 1b: NASDAQ Listing](index=9&type=section&id=Note%201b%3A%20NASDAQ%20Listing) - The company's securities have been listed and traded on the NASDAQ since March 2014[23](index=23&type=chunk) [Note 1c: Wholly Owned Subsidiaries](index=9&type=section&id=Note%201c%3A%20Wholly%20Owned%20Subsidiaries) - The company has three wholly-owned subsidiaries: MediWound Germany GmbH, MediWound UK Limited, and MediWound US, Inc (the latter two are currently inactive)[23](index=23&type=chunk) [Note 1d: BARDA Contracts](index=9&type=section&id=Note%201d%3A%20BARDA%20Contracts) - The company has two contracts with the U.S. Biomedical Advanced Research and Development Authority (BARDA) with a total value of up to **$209,000 thousand** for NexoBrid's development, manufacturing, and procurement as a medical countermeasure for mass casualty events[23](index=23&type=chunk) - On May 9, 2023, BARDA awarded the company an additional **$10,000 thousand** to support R&D activities, replenish expired products, and facilitate a pediatric indication sBLA submission[22](index=22&type=chunk) [Note 1e: Vericel NexoBrid Commercialization Issue](index=9&type=section&id=Note%201e%3A%20Vericel%20NexoBrid%20Commercialization%20Issue) - The company's partner, Vericel Corporation Inc, received the first batch of NexoBrid for the U.S. commercial market in June 2023 but is currently unable to release it due to a deviation at a third-party testing laboratory[23](index=23&type=chunk) - Both companies assess no additional risk to product quality and safety and are actively working with the FDA to resolve the issue; future production will not be affected as testing will be conducted directly by the company[23](index=23&type=chunk) [Note 1f: DoD Contract](index=9&type=section&id=Note%201f%3A%20DoD%20Contract) - In 2022, the company secured a **$1,800 thousand** contract with the U.S. Department of Defense (DoD) to develop NexoBrid as a non-surgical solution for U.S. Army field-of-care burn treatment[23](index=23&type=chunk) - This contract was amended in April 2023, extending its total value to **$2,700 thousand**[23](index=23&type=chunk) [Note 2: Significant Accounting Policies](index=10&type=section&id=Note%202%3A%20Significant%20Accounting%20Policies) This note outlines the basis of preparation for the financial statements in accordance with IFRS and their consistency with annual reports - The financial statements are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB)[24](index=24&type=chunk) - The interim condensed consolidated financial statements are prepared in accordance with International Accounting Standard 34, "Interim Financial Reporting"[24](index=24&type=chunk) - The interim financial statements should be read in conjunction with the company's annual financial statements as of December 31, 2022[25](index=25&type=chunk) - The accounting policies applied in these interim condensed consolidated financial statements are consistent with those followed for the annual consolidated financial statements as of December 31, 2022[26](index=26&type=chunk) [Note 3: Equity](index=10&type=section&id=Note%203%3A%20Equity) This note details equity-related activities in H1 2023, including a public offering, equity grants, and an increase in authorized shares [Note 3.1: Public Offering](index=10&type=section&id=Note%203.1%3A%20Public%20Offering) - On February 7, 2023, the company completed a public offering of **1,964,286 new ordinary shares** at a price of **$14.0 per share**, raising gross proceeds of **$27,500 thousand**[28](index=28&type=chunk) [Note 3.2: Share Options and RSUs Granted (February 2023)](index=10&type=section&id=Note%203.2%3A%20Share%20Options%20and%20RSUs%20Granted%20(February%202023)) - On February 15, 2023, the company granted **130,600 share options** (exercise price $13.32/share) and **9,100 RSUs** to employees and officers, with an estimated total value of **$1,129 thousand**, vesting over four years[28](index=28&type=chunk) [Note 3.3: Share Options Granted (April 2023)](index=10&type=section&id=Note%203.3%3A%20Share%20Options%20Granted%20(April%202023)) - On April 3, 2023, the company granted **160,400 share options** (exercise prices $11.89-$11.91/share) to board members and officers, with an estimated total value of **$884 thousand**, vesting over one to four years[28](index=28&type=chunk) [Note 3.4: Amendment to Articles of Association](index=10&type=section&id=Note%203.4%3A%20Amendment%20to%20Articles%20of%20Association) - On May 31, 2023, shareholders approved an amendment to increase the authorized share capital from 12,857,143 to **20,000,000 ordinary shares**[28](index=28&type=chunk) [Note 3.5: Increase in Equity Incentive Plan Shares](index=11&type=section&id=Note%203.5%3A%20Increase%20in%20Equity%20Incentive%20Plan%20Shares) - On May 31, 2023, shareholders approved an increase of **1,000,000 shares** available for issuance under the company's 2014 Equity Incentive Plan[31](index=31&type=chunk) [Note 3.6: Extension of Option Exercise Period](index=11&type=section&id=Note%203.6%3A%20Extension%20of%20Option%20Exercise%20Period) - On May 31, 2023, shareholders approved a five-year extension of the exercise period for options granted to directors on April 23, 2020, resulting in a recognized expense of **$146 thousand**[31](index=31&type=chunk) [Note 4: Subsequent events](index=11&type=section&id=Note%204%3A%20Subsequent%20events) This note discloses significant post-reporting period events, including a manufacturing expansion and a new long-term lease agreement [Note 4.1: Turnkey Scale-up Agreement with Biopharmax Group Ltd.](index=11&type=section&id=Note%204.1%3A%20Turnkey%20Scale-up%20Agreement%20with%20Biopharmax%20Group%20Ltd.) - On July 17, 2023, the company signed an agreement with Biopharmax Group Ltd to establish a GMP-compliant sterile manufacturing facility, aiming to increase NexoBrid production capacity **six-fold** to meet global demand[29](index=29&type=chunk) - The project is estimated to cost **$12,000 thousand** and is expected to be completed by mid-2024, with full operation anticipated in 2025[29](index=29&type=chunk) [Note 4.2: New Lease Agreement](index=11&type=section&id=Note%204.2%3A%20New%20Lease%20Agreement) - The company entered a new lease agreement for its existing and planned manufacturing facilities in Yavne, Israel, with a term extending to 2035 and an option to extend to 2038[30](index=30&type=chunk) - The property covers approximately **32,500 square feet** with an annual rent of about **$625 thousand**, linked to the Israeli CPI and subject to a 6% phased increase every three years[30](index=30&type=chunk)

MediWound Ltd. (NASDAQ:MDWD) Q1 2023 Earnings Conference Call May 30, 2023 8:30 AM ET Company Participants Monique Kosse - LifeSci Advisors, IR Ofer Gonen - Chief Executive Officer Hani Luxenburg - Chief Financial Officer Barry Wolfenson - Executive Vice President of Strategy & Corporate Development Conference Call Participants Josh Jennings - TD Cowen Francois Brisebois - Oppenheimer Michael Okunewitch - Maxim Group Swayampakula Ramakanth - H.C. Wainwright Operator Good day everyone and welcome to MediWoun ...