MDWD MediWound Ltd.

3.71
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Drug Stage Catalyst Date
NexoBrid
Severe burns
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EscharEx
Venous leg ulcers (VLU’s)
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Latest News

  1. YAVNE, Israel, Sept. 16, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "MediWound"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.  The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.  In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

    "The FDA's acceptance…

    YAVNE, Israel, Sept. 16, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "MediWound"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.  The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.  In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

    "The FDA's acceptance of the NexoBrid BLA submission for review is a major milestone for MediWound, and it is gratifying to know NexoBrid is one step closer to being available to help burn victims in the United States," said Sharon Malka, CEO of MediWound. "We thank all our partners for their commitment to this important program, and we look forward, together with BARDA and Vericel, to working with the FDA during the regulatory review process as we seek marketing approval for NexoBrid in the United States."

    Nick Colangelo, President and CEO of Vericel, added, "The FDA's acceptance of the NexoBrid BLA for review represents another important milestone toward our goal of providing a new standard of care for eschar removal in patients with severe burns and brings us one step closer to providing NexoBrid as a treatment option for the thousands of patients each year who suffer deep-partial and full-thickness burns that require debridement."

    The BLA submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal U.S. Phase 3 (DETECT) study of NexoBrid in adult patients with deep partial and/or full-thickness thermal burns up to 30% of total body surface area. The DETECT study successfully met its primary endpoint and all secondary endpoints, with a comparable safety profile. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union and other international markets. NexoBrid is currently an investigational product in the United States. Vericel Corporation (NASDAQ:VCEL) holds an exclusive license for North American commercial rights to NexoBrid. Funding and technical support for the development of NexoBrid is being provided by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    Vericel, our U.S. commercial partner, will host a virtual Analyst and Investor Day on Friday, October 16, 2020, from 9:00 a.m. - 11:00 a.m. EST which will focus on NexoBrid, which will include discussions with burn surgeon thought leaders on current burn debridement practices and how NexoBrid, upon approval, could change the current treatment paradigm for debridement of severe thermal burns.

    About NexoBrid

    NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union, and other international markets. Vericel holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30 percent of total body surface area. The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal. Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved. In addition, the twelve-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed. On June 29, 2020, a BLA was submitted to the U.S. FDA seeking the approval for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. Additional twenty-four-month long term safety follow up data will be submitted as a safety labeling update as part of a post-approval commitment.

    About MediWound

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid®, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    About BARDA

    The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies. For more information, refer to www.phe.gov/about/BARDA.

    Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid in the U.S. is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may  cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trial and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; the availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities; the timing of the NexoBrid delivery to BARDA, expected payments under the license agreement with Vericel; competitive developments; whether FDA will accept all or part of the BLA and provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of NEXT Study; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment, the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time.  These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.

    Contacts:

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.



                           

    Jeremy Feffer

    Managing Director, LifeSci Advisors

    212-915-2568

       

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  2. YAVNE, Israel, Sept. 03, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that Sharon Malka, MediWound's Chief Executive Officer, will present at the following investor conferences in September:

    2020 Wells Fargo Virtual Healthcare Conference
    Date: September 10, 2020
    Time: 8:40am ET
    Format: Virtual Presentation

    H.C. Wainwright 22nd Annual Global Investment Conference
    Date: Monday, September 14, 2020
    Time: 11:30am ET
    Format: Virtual Presentation

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
    Date: Monday, September 21, 2020
    Time: 3:20pm ET
    Format: Virtual Presentation…

    YAVNE, Israel, Sept. 03, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that Sharon Malka, MediWound's Chief Executive Officer, will present at the following investor conferences in September:

    2020 Wells Fargo Virtual Healthcare Conference

    Date: September 10, 2020

    Time: 8:40am ET

    Format: Virtual Presentation

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date: Monday, September 14, 2020

    Time: 11:30am ET

    Format: Virtual Presentation

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date: Monday, September 21, 2020

    Time: 3:20pm ET

    Format: Virtual Presentation

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    Contacts: Jeremy Feffer
    Boaz Gur-Lavie Jeremy Feffer
    Chief Financial Officer Managing Director, LifeSci Advisors
    MediWound Ltd. 212-915-2568
     

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  3. YAVNE, Israel and CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) and its U.S. commercial partner Vericel Corporation (NASDAQ:VCEL) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, has accepted the first shipment of NexoBrid® (concentrate of proteolytic enzymes enriched in Bromelain) as part of its mission to build national preparedness for public health emergencies. The initial BARDA procurement of NexoBrid is valued at $16.5 million, which includes additional quarterly deliveries planned through the end of 2021. In addition, BARDA holds…

    YAVNE, Israel and CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) and its U.S. commercial partner Vericel Corporation (NASDAQ:VCEL) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, has accepted the first shipment of NexoBrid® (concentrate of proteolytic enzymes enriched in Bromelain) as part of its mission to build national preparedness for public health emergencies. The initial BARDA procurement of NexoBrid is valued at $16.5 million, which includes additional quarterly deliveries planned through the end of 2021. In addition, BARDA holds an option to procure additional quantities of NexoBrid through funding of up to $50 million. 

    "This first shipment of NexoBrid is another major milestone in our longstanding partnership with BARDA, and we look forward to delivering the full procurement by the end of 2021," said MediWound Chief Executive Officer Sharon Malka. "The acceptance of the first delivery by BARDA during the ongoing COVID-19 pandemic underscores the importance of NexoBrid to U.S. national preparedness for the potential emergency treatment of large numbers of patients with severe thermal burns injuries."

    "The procurement of NexoBrid for our nation's response preparedness is one of many key NexoBrid activities occurring in 2020," said Nick Colangelo, President and Chief Executive Officer of Vericel. "This shipment, combined with the recent BLA submission and growing number of burn centers enrolled in the NexoBrid expanded access treatment protocol, bring us a step closer to ensuring that healthcare providers have both the supply and training needed to enzymatically debride burn patients, whether the need is due to individual accidents or a burn mass casualty event."

    On June 30, 2020, a Biologics License Application (BLA) was submitted to the U.S. Food and Drug Administration (FDA) seeking the approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. While the BLA is being reviewed by the FDA, burn centers across the U.S. are treating burn patients under the NexoBrid expanded access (NEXT) protocol.

    The procurement is a key milestone of the Project BioShield (PBS) contract between MediWound and BARDA which was signed in September 2015 with procurement initiated in January 2020. Under the PBS contract, BARDA provides funds and support for the advancement of the development and manufacturing of NexoBrid, as well as the procurement of NexoBrid as a medical countermeasure for mass casualty emergencies involving thermal burns. In May 2019, Vericel entered into exclusive license and supply agreements with MediWound to commercialize NexoBrid in North America. As part of the license agreement, Vericel and MediWound will equally split gross profits generated by BARDA's initial $16.5 million procurement.

    In October 2019, MediWound initiated the NEXT protocol, which is supported and funded by BARDA and enables the continued clinical use of NexoBrid for U.S. patients during the preparation and review of the NexoBrid BLA. NEXT is an open-label, single-arm treatment protocol which allows for the treatment of up to 150 burn patients with deep partial- and full-thickness thermal burns up to 30 percent of total body surface area. NEXT has been designed to be consistent with current real-life burn treatment practices in the U.S. and up to 30 U.S. burn centers are anticipated to participate. MediWound received FDA concurrence that patients can be treated under the NEXT protocol in a burn mass casualty incident that is not a declared national emergency.  Therefore, this provides a mechanism for U.S. burn centers to treat patients and gain valuable experience using Nexobrid prior to FDA approval as well as making the product readily available for response to mass burn emergencies.

    BARDA submitted a Pre-Emergency Use Authorization (PEUA) to FDA for the intended use of NexoBrid under an Emergency Use Authorization (EUA) during a declared emergency involving burn injuries. The availability of medical countermeasures (MCMs), such as Nexobrid, which mitigate preparedness gaps (like debridement and excision steps of burn care) will add to the United States Government's armamentarium for treatment of mass burn casualties. The EUA is a mechanism by which the FDA can allow an unapproved medical product that qualifies as a mass casualty medical countermeasure to be used in a public health emergency.

    About NexoBrid

    NexoBrid is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue.  NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union, and other international markets.  Vericel holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30 percent of total body surface area.  The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal.  Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved.  In addition, the twelve-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed.  On June 29, 2020, a BLA was submitted to the U.S. FDA seeking the approval for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. Additional twenty-four-month long term safety follow up data will be submitted as a safety labeling update as part of a post-approval commitment. NexoBrid is currently an investigational product in the United States.

    About Vericel Corporation

    Vericel is a leader in advanced therapies for the sports medicine and severe burn care markets.  The company markets two cell therapy products in the United States.  MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full-thickness burns greater than or equal to 30% of total body surface area.  The company also holds an exclusive license for North American commercial rights to NexoBrid, a registration-stage biological orphan product for debridement of severe thermal burns.  For more information, please visit the company's website at www.vcel.com.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    About BARDA

    Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid in the U.S. is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

    Cautionary Note Regarding Forward-Looking Statements

    This document contains forward-looking statements, including statements concerning the anticipated progress, development, objectives, expectations and commercial potential of NexoBrid. This release also includes forward-looking statements concerning the objectives and expectations regarding MediWound Ltd. and Vericel Corporation described herein, all of which involve certain risks and uncertainty. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements.

    Among the factors that may result in differences are the inherent uncertainties associated with: the timing and conduct of clinical trial and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid; the availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities; competitive developments; whether FDA will accept all or part of the BLA and provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of our NEXT; the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic. These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, Quarterly Reports on Form 6-K and other filings with the Securities and Exchange Commission ("SEC"), as well as information contained in Vericel's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on February 25, 2020, Quarterly Reports on Form 10-Q and other documents filed by the Company with the SEC from time-to-time.

    These forward-looking statements reflect Vericel's and MediWound's current views and neither Vericel nor MediWound undertakes any obligation to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

    Vericel Contacts:  
    Lee Stern  
    Solebury Trout  
      
    +1 (646) 378-2922  
       
    MediWound Contacts:  
    Boaz Gur-Lavie Jeremy Feffer
    Chief Financial Officer Managing Director, LifeSci Advisors
    MediWound Ltd. 212-915-2568
                                                                 

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  4. Submitted Biological License Application to the FDA for NexoBrid 
    EscharEx U.S. Phase 2 Study Resumed Patient Screening

    YAVNE, Israel, Aug. 06, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the second quarter ended June 30, 2020 and provided business and financial updates related to the COVID-19 pandemic. 

    Second Quarter Business and Financial Highlights:

    • Revenues for the second quarter of 2020 were $4.0 million, compared with $20.7 million for the second quarter of 2019, which included the upfront payment of $17.5 million…

    Submitted Biological License Application to the FDA for NexoBrid 

    EscharEx U.S. Phase 2 Study Resumed Patient Screening

    YAVNE, Israel, Aug. 06, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the second quarter ended June 30, 2020 and provided business and financial updates related to the COVID-19 pandemic. 

    Second Quarter Business and Financial Highlights:

    • Revenues for the second quarter of 2020 were $4.0 million, compared with $20.7 million for the second quarter of 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement

       
    • The Company had $24.4 million in cash and short-term investments as of June 30, 2020, compared with $29.5 million as of December 31, 2019

       
    • Resumed patient screening and randomization in U.S. EscharEx® phase 2 adaptive design study for the treatment of venous leg ulcers ("VLU's"); Interim assessment is anticipated in the first half of 2021

       
    • Submitted Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for NexoBrid® for the treatment of severe thermal burns in adults

       
    • Instituted a series of measures to address challenges associated with the COVID-19 pandemic, while maintaining workforce and operational capacity and flexibility

    "We are pleased to have submitted the BLA for NexoBrid on schedule despite the disruptions of the COVID-19 pandemic. This submission is a major milestone in our long-term partnership with BARDA, and we are actively preparing for the commercial launch with our partner, Vericel, upon approval," said Sharon Malka, Chief Executive Officer of MediWound. "In addition, we are actively recruiting and enrolling patients in our U.S. EscharEx phase 2 study, and we are encouraged to see progress in moving this trial forward."

    Mr. Malka concluded, "In recent months, humanity is facing tremendous challenges with a great deal of uncertainty. We are privileged to be among those tasked with improving patients' quality of care and impacting their lives. Our solid balance sheet continues to support our growth as we execute on our strategic plans, and we are optimistic that we will continue to successfully strengthen our Company."

    Corporate Update

    MediWound has implemented several measures to safeguard the health and well-being of its employees, their families, and healthcare providers. The Company has reduced expenses to minimize impact to operations while ensuring full compliance with all necessary regulations. Management continues to assess the impact of the pandemic, the potential implications to business continuity, and necessary remedies and will adjust accordingly to the challenges created by any directives from regulatory authorities.

    The Company continues to manufacture and supply NexoBrid to patients with severe burn injuries, including manufacturing NexoBrid and building an emergency stockpile for the U.S. Biomedical Advanced Research and Development Authority (BARDA), while the first delivery to BARDA is planned in the third quarter of 2020. The Company maintains a significant safety stock of all key raw materials and NexoBrid inventory to meet expected demand over the next several quarters. At this time, the Company does not expect any disruptions to its manufacturing operations and global supply chain.



    The Company submitted a BLA to the U.S. FDA seeking the approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and full-thickness thermal burns. The BLA submission is based on multiple preclinical and clinical studies including the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with severe thermal burns. Vericel Corporation (NASDAQ:VCEL) holds an exclusive license for North American commercial rights of NexoBrid. MediWound is eligible to receive a $7.5 million milestone payment from Vericel upon BLA approval.



    On the clinical front, the Company has resumed new patients' screening and randomization in its U.S. EscharEx phase 2 adaptive design study for the treatment of VLU's and expects to achieve the pre-defined interim assessment in the first half of 2021. In addition, enrollment in the NexoBrid expanded access (NEXT) program continues with enhanced safety measures, such as remote visits and virtual tools.

    The Company had $24.4 million in cash and short-term investments as of June 30, 2020, compared with $29.5 million as of December 31, 2019, with no debt. The Company reiterates its expectations of cash use for operating activities in 2020 to be in the range of $8 to $10 million.  At this time, the Company cannot predict the extent or duration of the impact of the COVID-19 outbreak on its ongoing financial and operational results.

    Second Quarter Financial Results

    Revenues for the second quarter of 2020 were $4.0 million, compared with $20.7 million for the second quarter of 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement. Revenues from product in the second quarter of 2020 were $1.1 million, reflecting an increase of 17% in comparison to the second quarter of 2019, excluding the one-time upfront payment.

    Gross profit for the second quarter of 2020 was $1.2 million, compared to a gross profit of $17.5 million for the second quarter of 2019, which included $16.8 million from the Vericel licensing agreement. 

    Research and development expenses for the second quarter of 2020, net of participations, were $1.6 million, compared with $0.4 million for the second quarter of 2019. The increase was primarily due to decrease of participation by BARDA and Israeli Innovation Authority (IIA).  

    Selling, general and administrative expenses for the second quarter of 2020 were $2.3 million, in line with the second quarter of 2019.

    Operating loss for the second quarter of 2020 was $2.7 million, compared with an operating profit of $13.9 million in the second quarter of 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement, net of royalty payment of $0.7 million and $0.8 million of other expenses. 

    The Company posted a net loss of $3.1 million, or $0.11 per share, for the second quarter of 2020 compared with a net profit of $12.7 million, or $0.47 per share, for the second quarter of 2019, which included the $17.5 million upfront license payment, net of royalty payment of $0.7 million and $0.8 million of other expenses. Excluding the upfront license payment net of deal related costs, net loss for the second quarter of 2019 was $3.3 million, or $0.12 per share.

    Adjusted EBITDA, as defined below, for the second quarter of 2020 was a loss of $2.1 million, compared with a profit of $15.4 million for the second quarter of 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement, net of royalty payment of $0.7 million.                                                  

    Year-to-Date 2020 Financial Results

    Revenues for the first half of 2020 were $8.5 million compared with $21.2 million in the first half of 2019, which included the $17.5 million upfront payment from the Vericel licensing agreement for NexoBrid.

    The Company's net loss for the first half of 2020 was $5.6 million or  $0.20 per share compared with net profit of $8.6 million or  $0.32 per share for the first half of 2019, which included the $17.5 million upfront license payment, net of royalty payment of $0.7 million and $0.9 million of other expenses. Excluding the upfront license payment net of deal related costs, net loss for the first half of 2019 was $7.3 million, or $0.27 per share.

    Adjusted EBITDA, for the first half of 2020, was a loss of $3.9 million, compared with a profit of $12.4 million for the first half of 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement, net of royalty payment of $0.7 million. 

    Conference Call

    MediWound management will host a conference call for investors today, Thursday, August 6, 2020 beginning at 8:30 a.m. Eastern Time to discuss these results and answer questions.  Shareholders and other interested parties may participate in the conference call by dialing 877-602-7189 (in the U.S.)  1809 315 362 (Israel), or 678-894-3057 (outside the U.S. & Israel) and entering passcode 3176168. The call also will be webcast live on the Company's website at http://ir.mediwound.com/events-and-presentations.

    A replay of the call will be accessible two hours after its completion through August 27, 2020 by dialing 855-859-2056 (in the U.S.) or 404-537-3406 (outside the U.S.) and entering passcode 3176168. The call will also be archived on the Company website for 90 days at www.mediwound.com.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com

    About BARDA

    The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies. For more information, refer to www.phe.gov/about/BARDA. Funding and technical support for development of NexoBrid to obtain marketing approval in the U.S. including the expanded access treatment protocol (NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid in the U.S. is provided by BARDA, under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of NexoBrid and EscharEx. Among the factors that may  cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trial and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; the availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities; the timing of the NexoBrid delivery to BARDA, expected payments under the license agreement with Vericel; competitive developments; whether FDA will accept all or part of the BLA and provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of NEXT Study; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment, the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time.  These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law. 

    Contacts: Investors:
    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

     
    Jeremy Feffer

    Managing Director, LifeSci Advisors

    212-915-2568

     



    MediWound, Ltd.
     
    CONDENSED CONSOLIDATED BALANCE SHEETS

    U.S. dollars in thousands
     
      June 30, December 31,
      2020 2019 2019
           
      Un-audited Audited
    Cash, cash equivalents and short term deposits 24,382 38,712 29,458
    Accounts and other receivable 3,492 4,668 4,557
    Inventories 1,934 1,535 1,613
    Total current assets 29,808 44,915 35,628
           
    Property, plant and equipment, net 2,326 2,183 2,304
    Right of use assets, net 2,086 2,315 2,229
    Intangible assets, net 396 462 429
    Total long-term assets 4,808 4,960 4,962
           
    Total assets 34,616 49,875 40,590
           
    Current maturities of long-term liabilities 1,321 896 569
    Trade payables and accrued expenses 2,423 4,073 4,067
    Other payables 6,040 5,889 5,737
    Total current liabilities 9,784 10,858 10,373
           
    Deferred revenues 1,174 1,144 1,135
    Liability in respect of Israeli Innovation Authority grants net of current maturity 7,130 6,919 6,811
    Contingent consideration for the purchase of shares net of current maturity 4,249 4,412 4,853
    Liability in respect of discontinued operation - 6,003 -
    Lease liabilities, net of current maturity 1,866 2,022 2,006
    Severance pay liabilities, net 281 338 243
    Total long-term liabilities 14,700 20,838 15,048
           
    Shareholders' equity 10,132 18,179 15,169
    Total liabilities & shareholder equity 34,616 49,875 40,590



    MediWound, Ltd.
     
    CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE PROFIT (LOSS) (ANAUDITED)

    U.S. dollars in thousands
     
     Six months ended Three months ended
     June 30, June 30,
     2020 2019 2020 2019
            
    Revenues8,465 21,207 4,027 20,746
    Cost of revenues6,018 3,788 2,809 3,481
    Gross profit 2,447 17,419 1,217 17,265
            
    Operating expenses:       
    Research and development, gross3,312 6,075 1,593 1,893
    Participation by BARDA & IIA19 -4,624 19 -1,721
    Research and development, net3,331 1,451 1,612 172
    Selling, general & administrative4,028 4,708 2,311 2,343
    Other expenses- 901 - 812
    Operating profit (loss)(4,912) 10,359 (2,706) 13,938
    Financial expenses, net(645) (1,803) (390) (1,222)
    Profit (loss) from continuing operations(5,557) 8,556 (3,096) 12,716
    Profit from discontinued operation- 50 0 0
    Profit (loss) for the period(5,557) 8,606 (3,096) 12,716
    Foreign currency translation adjustments1 2 0 (2)
    Total comprehensive profit (loss)(5,556) 8,608 (3,096) 12,714
            
    Net Profit (loss) per share(0.20) 0.32 (0.11) 0.47
    Weighted average number of ordinary shares used in the computation

    of basic and diluted profit (loss) per share:
    27,207 27,179 27,211 27,179
            



    MediWound, Ltd.
     
    ADJUSTED EBITDA 

    U.S. dollars in thousands
        
     Six months ended Three months ended
     June 30, June 30,
     2020 2019 2020 2019
    Profit (loss) for the period(5,557) 8,606 (3,096) 12,716
            
    Adjustments:       
    Financial expenses, net(645) (1,803) (390) (1,222)
    Profit from discontinued operation- 50 - -
    Other expenses- (901) - (812)
    Depreciation and amortization(539) (552) (271) (278)
    Share-based compensation expenses(519) (599) (346) (324)
    Total adjustments(1,703) (3,805) (1,007) (2,636)
    Adjusted EBITDA (3,854) 12,411 (2,089) 15,352
            



    MediWound, Ltd.
     
    CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW

    (UNAUDITED)

    U.S. dollars in thousands
        
     Six months ended

    June 30, 
     Three months ended

    June 30,
     2020 2019 2020 2019
    Cash Flows from Operating Activities:     
    Net profit (loss)(5,557) 8,606 (3,096) 12,716
          
    Adjustments to reconcile net profit (loss) to net cash used in continuing operating activities:     
    Adjustments to profit and loss items:     
    Profit from discontinued operation- (50) - -
    Depreciation and amortization539 552 271 278
    Share-based compensation519 599 346 324
    Revaluation of liabilities in respect of IIA grants424 (392) 226 (466)
    Revaluation of contingent consideration for the purchase of shares348 1,322 196 1,081
    Revaluation of lease liabilities64 194 100 91
    Increase (decrease) in severance liability, net40 (10) 19 13
    Financing income(191) (149) (81) (87)
    Unrealized foreign currency (gain) loss28 (70) (51) 60
     1,771 1,996 1,026 1,294
    Changes in asset and liability items:     
    Decrease (increase) in trade receivables1,341 (9) 444 (318)
    Decrease (increase) in inventories(326) 146 65 (62)
    Decrease (increase) in other receivables(284) 2,744 (383) 2,482
    Increase (decrease) in trade payables(1,649) 1,357 (1,004) 1,076
    Increase in other payables & deferred revenues86 529 133 77
     (832) 4,767 (745) 3,255
    Net cash provided by (used in) continuing operating activities(4,618) 15,369 (2,815) 17,265
    Net cash provided by discontinued operating activities- 50  -
    Net cash provided by (used in)  operating activities(4,618) 15,419 (2,815) 17,265
          



    MediWound, Ltd.
     
    CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW

    (UNAUDITED)-Cont.

    U.S. dollars in thousands
        
     Six months ended

    June 30, 

     Three months ended

    June 30, 


     2020 2019 2020 2019
             
    Cash Flows from Investment Activities:       
    Purchase of property and equipment(244) (433) (100) (194)
    Interest received42 44 39 14
    Proceeds from short term bank  deposits, net of investments10,595 2,977 7,603 412
    Net cash provided by investing activities10,393 2,588 7,542 232
     



    Cash Flows from Financing Activities:
           
    Repayment of lease liabilities(313) (312) (153) (157)
    Proceeds from IIA grants, net of repayments(66) 193 - 248
    Net cash (used in) provided by financing activities(379) (119) (153) 91
            
    Exchange rate differences on cash and cash equivalent balances(26) 63 57 (55)
            
    Increase in cash and cash equivalents from continuing activities5,370 17,901 4,631 17,533
    Increase in cash and cash equivalents from discontinued activities- 50 - -
    Balance of cash and cash equivalents at the beginning of the period7,242 6,716 7,981 7,134
    Balance of cash and cash equivalents at the end of the period12,612 24,667 12,612 24,667

     

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  5. YAVNE, Israel, July 28, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the Company will release its financial results for the second quarter ended June 30, 2020 at 7:00 am Eastern Time on Thursday, August 6, 2020.

    Following the release, MediWound's management will host a conference call and live webcast on Thursday, August 6, 2020 at 8:30 am Eastern Time to discuss the financial results and to answer questions. Dial-in and call details are as follows:

    Conference Call & Webcast Details 
    Toll-Free:877-602-7189
    Israel Toll-Free:1 809 315 362
    International:678-894-3057
    Conference ID:3176168

    YAVNE, Israel, July 28, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the Company will release its financial results for the second quarter ended June 30, 2020 at 7:00 am Eastern Time on Thursday, August 6, 2020.

    Following the release, MediWound's management will host a conference call and live webcast on Thursday, August 6, 2020 at 8:30 am Eastern Time to discuss the financial results and to answer questions. Dial-in and call details are as follows:

    Conference Call & Webcast Details 
    Toll-Free:877-602-7189
    Israel Toll-Free:1 809 315 362
    International:678-894-3057
    Conference ID:3176168
    Webcast:https://edge.media-server.com/mmc/p/jt3zx63y

    To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call.  An archived version of the webcast will be available for replay for 90 days in the Investors section of the MediWound website.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid.  In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications.  For more information, please visit www.mediwound.com.

    Contacts: 
    Boaz Gur-Lavie Jeremy Feffer
    Chief Financial OfficerManaging Director
    MediWound Ltd.LifeSci Advisors, LLC
      

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