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MediWound(MDWD) - 2023 Q3 - Earnings Call Transcript
2023-11-21 18:14
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(MDWD) - 2023 Q3 - Quarterly Report
2023-11-21 12:05
[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)
MediWound(MDWD) - 2023 Q2 - Quarterly Report
2023-08-15 20:10
Exhibit 99.2 MEDIWOUND LTD. AND ITS SUBSIDIARIES CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2023 IN U.S. DOLLARS IN THOUSANDS UNAUDITED INDEX | Page | | | --- | --- | | Unaudited Condensed Interim Consolidated Statements of Financial Position | F-2 | | Unaudited Condensed Interim Consolidated Statements of Profit or Loss and Other Comprehensive Income | F-3 | | or Loss | | | Unaudited Condensed Interim Consolidated Statements of Changes in Shareholders' Equity (Deficit) | F-4 – F-5 | ...
MediWound(MDWD) - 2023 Q1 - Earnings Call Transcript
2023-05-30 14:53
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 ...
MediWound(MDWD) - 2022 Q4 - Earnings Call Transcript
2023-03-16 18:30
MediWound Ltd. (NASDAQ:MDWD) Q4 2022 Earnings Conference Call March 16, 2023 8:30 AM ET Company Participants Monique Kosse - LifeSci Advisors, IR Ofer Gonen - Chief Executive Officer Boaz Gur-Lavie - Chief Financial Officer Conference Call Participants Josh Jennings - TD Cowen Francois Brisebois - Oppenheimer Swayampakula Ramakanth - H.C. Wainwright Michael Okunewitch - Maxim Group Operator Good day. And welcome to MediWound???s Fourth Quarter and Year End 2022 Earnings Call. Today???s conference is being r ...
Mediwound (MDWD) Investor Presentation - Slideshow
2023-03-16 18:14
Kodak Ofer Gonen Cash of ~$66M** *TAM - targeted addressable market; Source: Oliver Wyman market research ** includes $27.5M raised in February 2023 Global strategic collaborations BARDA, Vericel, DoD (US), Kaken (JP), BSV (IN) Solid balance sheet & strong investor base Leadership Team | --- | --- | --- | |------------------------------------------------------------------------|-------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Non-Surgical Biotherapeutic Solutions for Tissue Repair ...
MediWound(MDWD) - 2023 Q1 - Quarterly Report
2023-03-16 11:15
Exhibit 99.1 MediWound Reports Fourth Quarter and Full Year 2022 Financial Results and Company Update 2022 total revenues of $26.5 million FDA approval of NexoBrid® in December 2022; U.S. commercial availability expected in the second quarter of 2023 EscharEx® Phase III protocol design is under review by the FDA; study to be initiated in the second half of 2023 Cash position of $66 million, including cash received for the NexoBrid approval milestone and recent equity financing Conference call begins today a ...
MediWound(MDWD) - 2022 Q4 - Annual Report
2023-03-16 11:05
Regulatory Compliance and Legal Risks - Non-compliance with healthcare laws may lead to significant civil, criminal, and administrative penalties, including exclusion from federal healthcare programs [113]. - Violations of the federal Anti-Kickback Statute can result in civil monetary penalties for each violation, plus up to three times the remuneration involved [115]. - The federal False Claims Act allows for treble damages and penalties for each false claim submitted, impacting pharmaceutical and healthcare companies [116]. - Companies may face substantial damages and fines for improper incentives leading to false claims, necessitating Corporate Integrity Agreements to avoid exclusion from federal programs [118]. - Increased regulation of payments to healthcare professionals may result in significant civil monetary penalties for non-compliance with reporting requirements [120]. - The company must ensure compliance with state and foreign laws regarding healthcare marketing arrangements to avoid legal repercussions [121]. - The company is subject to GDPR compliance, facing potential fines of up to €20 million or 4% of annual global revenues for noncompliance [127]. - The UK GDPR mirrors the GDPR fines, with potential penalties of up to £17.5 million or 4% of global turnover [128]. - The company is subject to the U.S. Foreign Corrupt Practices Act, which prohibits improper payments to officials, potentially affecting operations in regions with governmental corruption [123]. Data Protection and Cybersecurity - Compliance with evolving data protection laws, such as HIPAA and CCPA, may impose high costs and create complex compliance issues for the company [124]. - The California Consumer Privacy Act (CCPA) and California Privacy Rights Act (CPRA) impose new data privacy obligations and could increase risks associated with data breaches [125]. - The company has implemented security measures but cannot guarantee that data protection will not be breached, which could adversely affect financial results [130]. - The company is increasingly dependent on information technology systems, making it vulnerable to cyberattacks and system failures [131]. Intellectual Property and Patent Risks - The company relies on a combination of patents and trade secret laws to protect its intellectual property, but there is no assurance that these protections will be adequate [142]. - The company may face challenges to its patent protection, which could significantly affect its competitive advantage [145]. - The company may incur substantial costs from litigation related to intellectual property rights, which could divert management's attention from product development [147]. - There is a risk that the company may not be able to protect its intellectual property rights in all jurisdictions, limiting its ability to exclude competitors [150]. - The company may face claims for remuneration or royalties for assigned service invention rights by employees, which could result in litigation [163]. - Currently issued patents for NexoBrid are set to expire between 2025 and 2029, potentially limiting competitive advantages [151]. - The international PCT patent applications for EscharEx were filed on January 30, 2017, with an expiration date of January 30, 2037, absent patent-term adjustments [151]. - The company may be subject to claims that it infringes on third-party intellectual property rights, which could result in substantial expenses and operational disruptions [158]. - The company may not be able to enforce non-competition agreements with employees, potentially allowing competitors to benefit from the expertise of former employees [162]. Financial and Market Risks - Changes in tax legislation, such as the Inflation Reduction Act of 2022, could materially impact the company's financial condition and results of operations [140]. - The company may face adverse tax consequences for U.S. shareholders if classified as a passive foreign investment company (PFIC), which could affect the treatment of gains and dividends [182]. - The market price of the company's ordinary shares has fluctuated significantly, trading as high as $127.12 and as low as $8.47 since its IPO [165]. - The company’s ability to raise capital may be impaired if a substantial number of ordinary shares are sold in the public market, potentially leading to a decline in share price [168]. - The company has registered the resale of 1,605,732 shares under a shelf registration statement, which may lead to significant fluctuations in the market price of ordinary shares [169]. - The company entered into an Open Market Sales Agreement with Jefferies LLC to issue and sell ordinary shares with gross sales proceeds of up to $15 million, although no shares have been sold under this agreement as of the date [169]. - The company may incur additional costs related to enhancing internal controls and financial reporting systems to comply with regulatory requirements [179]. Operational Risks - The company is subject to extensive environmental, health, and safety regulations, which could lead to substantial liabilities in case of noncompliance [139]. - The company faces risks related to product liability claims, with insurance coverage of up to $10 million for claims in countries where NexoBrid is sold [137]. - The company’s operations are significantly affected by political, economic, or military instability in Israel, where its headquarters and key operations are located [185]. - The company has experienced multiple national elections in Israel over the past two years, contributing to political instability [185]. - Employees based in Israel may be called for military service, potentially disrupting operations, with some required to serve up to 54 days every three years [189]. - The company faces risks from boycotts and restrictions in the Middle East, which may adversely impact product sales [191]. - Israeli corporate law may impede mergers or acquisitions, requiring a 95% positive response for tender offers and additional approvals [192]. - Tax considerations under Israeli law may make potential transactions less appealing, as tax-free share exchanges are not recognized to the same extent as in U.S. law [193]. - The company must comply with the Encouragement of Research, Development and Technological Innovation in the Industry Law, which restricts the transfer of IIA-supported technology outside of Israel [197]. - The quorum for shareholder meetings is lower than customary, requiring only two shareholders holding at least 25% of outstanding shares [202]. - The trading market for the company's shares relies on equity research analysts, and unfavorable commentary could lead to a decline in share price [203]. Grants and Financial Support - As of December 31, 2022, the total gross amount of grants received from the Israeli Innovation Authority (IIA) was approximately $13.6 million, with an amortized liability cost of about $7.6 million [194]. - The company accrued and paid net royalties to the IIA amounting to $1.6 million as of December 31, 2022 [194]. - The company has not applied for IIA grants since 2018 and does not plan to submit applications in 2023 [194].
MediWound(MDWD) - 2022 Q3 - Earnings Call Transcript
2022-11-15 17:30
Financial Data and Key Metrics Changes - Total revenues for Q3 2022 were $5.8 million, a decrease from $6.4 million in Q3 2021 [30] - Revenues from products in Q3 2022 were $1.4 million, down from $2.6 million, primarily due to a $1 million decrease in emergency stockpile procurement by BARDA [30] - Gross profit for Q3 2022 was $2.4 million, or 42% of net revenues, compared to a gross profit of $2.5 million, or 39% of net revenues in the prior year [30] - Operating loss for Q3 2022 was $3.5 million, compared to $2.9 million in Q3 2021 [33] - Net loss for Q3 2022 was $4.2 million, or $0.13 per share, compared to a net loss of $3.3 million, or $0.12 per share in the previous year [34] - Adjusted EBITDA for Q3 2022 was a loss of $2.5 million, compared to a loss of $2.2 million in Q3 2021 [35] Business Line Data and Key Metrics Changes - The company is focused on the NexoBrid and EscharEx products, with NexoBrid expected to generate meaningful revenues in 2023 [9][10] - EscharEx has shown robust Phase 2 results, proving to be safe and effective, with plans to initiate a Phase 3 study in the first half of 2023 [15][17] Market Data and Key Metrics Changes - NexoBrid's BLA resubmission was accepted by the FDA, with a PDUFA date set for January 1, 2023 [20] - The company anticipates significant growth in NexoBrid sales in Europe and is preparing for launches in India and Japan [22][25] Company Strategy and Development Direction - The company aims to leverage a $1 billion market opportunity with EscharEx and has a mature pipeline with favorable data [10] - A strategic advisory board has been established to enhance operational activities and manufacturing processes [14] - The company is evaluating options for collaboration on EscharEx while maintaining flexibility due to recent funding [19][64] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing significant catalysts ahead, including anticipated marketing approvals for NexoBrid [39] - The company is scaling up manufacturing to meet growing demand and is prepared for pivotal development programs [40] - Management highlighted the importance of the pediatric market for NexoBrid, which represents a significant opportunity [58] Other Important Information - The company completed a capital raise of $30 million to support activities through 2025 [11][38] - The company has $17.6 million in cash and short-term investments as of September 30, 2022, compared to $11 million at the end of 2021 [37] Q&A Session Summary Question: Progress on EscharEx and FDA interactions - Management confirmed they will meet with the FDA to discuss the Phase 3 study design and are considering strategic partnerships [44] Question: Revenue potential from NexoBrid - Expected $7.5 million milestone payment from Vericel upon BLA approval, with additional revenue anticipated from launches in Japan and India [46] Question: Design of Phase 3 study for EscharEx - Management aims for a similar design to the successful Phase 2 study and expects clarity on regulatory paths soon [49][51] Question: Expanded Access Program (EAP) insights - The EAP has treated 183 patients, providing valuable feedback that supports the belief that NexoBrid will become standard care in the U.S. [57] Question: Market management strategies in India and Japan - The company has established partnerships in both markets and is optimistic about the acceptance of NexoBrid [61][62] Question: Potential collaborations for EscharEx - Management is receiving interest from strategic players and is flexible in terms of partnerships due to recent funding [64]
MediWound(MDWD) - 2022 Q3 - Quarterly Report
2022-11-09 21:05
Exhibit 99.1 INDEX | | Page | | --- | --- | | Unaudited Condensed Interim Consolidated Statements of Financial Position | F-2 | | Unaudited Condensed Interim Consolidated Statements of Profit or Loss and Other Comprehensive Income | F-3 | | or Loss | | | Unaudited Condensed Interim Consolidated Statements of Changes in Shareholders' Equity (Deficit) | F-4 – F-5 | | Unaudited Condensed Interim Consolidated Statements of Cash Flows | F-6 – F-7 | | Notes to Unaudited Condensed Interim Consolidated Financial St ...