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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 ...
MediWound(MDWD) - 2022 Q2 - Earnings Call Presentation
2022-08-10 04:36
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MediWound(MDWD) - 2022 Q2 - Earnings Call Transcript
2022-08-10 04:31
MediWound Ltd. (NASDAQ:MDWD) Q2 2022 Earnings Conference Call August 9, 2022 8:30 AM ET Company Participants Monique Kosse - Investor Relations Ofer Gonen - Chief Executive Officer Boaz Gur-Lavie - Chief Financial Officer Conference Call Participants Bryan Bergin - Cowen Ryan Zimmerman - BTIG Arthur He - H.C. Wainwright Operator Good day and welcome to MediWound???s Second Quarter 2022 Earnings Call. Today???s conference is being recorded. At this time, I would like to turn the conference over to Monique Ko ...
MediWound(MDWD) - 2022 Q2 - Quarterly Report
2022-08-09 11:35
Exhibit 99.2 MEDIWOUND LTD. AND ITS SUBSIDIARIES CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS INDEX | | Page | | --- | --- | | Condensed Interim Consolidated Statements of Financial Position | F-2 | | Condensed Interim Consolidated Statements of Profit or Loss and Other Comprehensive Income or Loss | F-3 | | Condensed Interim Consolidated Statements of Changes in Shareholders' Equity (Deficit) | F-4 – F-5 | | Condensed Interim Consolidated Statements of Cash Flows | F-6 – F-7 | | Notes to Condensed I ...
MediWound(MDWD) - 2022 Q1 - Earnings Call Transcript
2022-05-17 16:04
MediWound Ltd. (NASDAQ:MDWD) Q1 2022 Earnings Conference Call May 17, 2022 8:30 AM ET Company Participants Monique Kosse - IR Sharon Malka - CEO Boaz Gur-Lavie - Chief Financial Officer Ofer Gonen - Board Member Lior Rosenberg - Chief Medical Officer Cyaandi R. Dove - Investigator, Advanced Wound & Ankle Center, Las Vegas Conference Call Participants Unidentified Analyst - Cowen and Company Kevin DeGeeter - Oppenheimer Arthur He - H.C. Wainwright Operator Good day and welcome to the MediWound First Quarter ...