MediWound(MDWD)

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MediWound(MDWD) - 2023 Q2 - Quarterly Report
2023-08-15 20:10
[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(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 ...
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 ...