midastouch017
4 weeks ago
MediWound Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Company Update.
https://finance.yahoo.com/news/mediwound-reports-fourth-quarter-full-110000175.html
$19 million revenue in 2023; $24 million projected revenue in 2024
NexoBrid® commercially launched in U.S., Japan, India
Potential blockbuster EscharEx® to begin Phase III in the second half of 2024
$42 million cash runway through profitability
Conference call today, March 21 at 8:30am Eastern Time
YAVNE, Israel, March 21, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.
“2023 was an exceptional year for NexoBrid driven by new market launches, expanded indications, substantial new governmental grants, and increased global demand. Additionally, this lifesaving treatment was successfully battle-tested in real-life burn mass casualty incidents (BMCI) during the war in Israel. Furthermore, the full capacity of our new manufacturing facility in 2025 will enable us to meet the soaring demand of NexoBrid,” said Ofer Gonen, CEO of MediWound. “Recent clinical data further validates our pipeline product, EscharEx, demonstrating that it significantly outperformed SANTYL® in a head-to-head comparative analysis. The product has attracted research collaborations with industry leaders 3M, Mölnlycke and MIMEDX and the Phase III study is set to begin in the second half of 2024. We strongly believe in the exciting future ahead for MediWound.”
2023 Highlights and Recent Developments:
NexoBrid®
Expanded commercial availability to U.S., Japan, and India, leading to $19 million revenue in 2023, and a surge of orders for 2024, with $24 million projected revenue.
Construction of a new GMP-compliant state-of-the-art manufacturing facility is on track for mid-2024 completion. It is projected to achieve a 6-fold manufacturing capacity increase in 2025.
Commercial Activities:
Launched in the U.S. by Vericel Corp, with more than 50 burn centers submitting packages to Pharmacy and Therapeutics (P&T) committees and more than 25 already approved. Furthermore, the Centers for Medicare & Medicaid Services (CMS) awarded NexoBrid a permanent J code and granted it transitional pass-through payment status, enhancing its accessibility and reimbursement potential.
Launched in Japan through Kaken Pharmaceuticals, and in India through Bharat Serums and Vaccines (BSV).
Expanded European market presence by establishing a collaboration with PolyMedics Innovations (PMI) for the promotion of NexoBrid in Germany, Austria, Belgium, the Netherlands, and Luxembourg.
Successfully fulfilled emergency demand in Israel to treat mass burn casualties resulting from the war, consuming all available non-U.S. inventory.
Government Funding:
Awarded $13.0 million R&D funding by U.S. Department of Defense (DoD) to develop and produce a new NexoBrid temperature stable formulation for use as a non-surgical solution for field-care burn treatment for the U.S. Army.
Awarded $10.1 million in additional funding from the Biomedical Advanced Research and Development Authority (BARDA) for emergency preparedness product replenishment and R&D activities.
Pediatric label expansion:
Gained European Commission approval for the removal of eschar in deep partial- and full-thickness thermal burns for all ages.
Supplemental BLA for pediatric indication accepted for review by the U.S. Food and Drug Administration (FDA). Decision expected in the second half of 2024.
EscharEx®
Aligned the Phase III study protocol with the European Medicine Agency (EMA) and the FDA, and expected to submit a final protocol in the first half of 2024. 216 patients will be treated globally across 40 sites with either EscharEx or a gel vehicle placebo, with an interim assessment to be performed once 67% of participants complete the study. Study initiation is expected in the second half of 2024.
Established research collaborations with 3M, Mölnlycke and MIMEDX to support the EscharEx Phase III clinical study.
Conducted head-to-head comparative analysis of EscharEx vs SANTYL®. Data from a Phase II randomized controlled study demonstrated significant superiority of EscharEx over SANTYL in multiple clinical outcome measures: incidence of complete debridement; median time to achieve complete debridement; incidence of achieving wound bed preparation (WBP); median time to achieve WBP; and time to wound closure. The data is scheduled for oral presentation in May 2024 at three leading annual congresses dedicated to advanced wound care: The Wound Healing Society (WHS), the Symposium on Advanced Wound Care (SAWC), and the European Wound Management Association (EWMA).
MW005
Reported positive results of the Phase I/II study to evaluate the safety and efficacy of MW005 in the treatment of low-risk Basal Cell Carcinoma (BCC). The data showed MW005 to be safe and well-tolerated, with patients achieving complete clinical and histological clearance of their target lesions.
Fourth Quarter 2023 Financial Highlights
Revenue: Revenue for the fourth quarter 2023 was $5.3 million, compared to $11.6 million in the fourth quarter of 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.
Gross Profit: Gross profit in the fourth quarter 2023 was $0.7 million, representing 13.5% of the total revenue in the fourth quarter of 2023, compared to $8.2 million, representing 70.2% of total revenue in the fourth quarter of 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel in the fourth quarter of 2022.
Expenditures:
Research and development expenses in the fourth quarter 2023 were $1.8 million compared to $2.7 million in the fourth quarter of 2022. This change is primarily attributed to the completion of EscharEx phase II study in 2022.
Selling, general, and administrative expenses in the fourth quarter 2023 were $2.8 million, compared to $3.0 million in the fourth quarter of 2022.
Operating Results: Operating loss in the fourth quarter of 2023 was $3.9 million, compared to an operating profit of $2.1 million in the fourth quarter of 2022.
Net Loss: Net loss in the fourth quarter of 2023 was $1.7 million or $0.19 per share, compared to the net loss of $7.5 million, or $1.18 per share in the fourth quarter of 2022. The decrease is primarily attributed to a favorable adjustment from the revaluation of warrants.
Non-GAAP Adjusted EBITDA: Adjusted EBITDA in the fourth quarter of 2023 was a loss of $3.2 million, compared to a profit of $3.4 million in the fourth quarter of 2022.
Full Year 2023 Financial Highlights
Revenue: Revenue for the year ended December 31, 2023, was $18.7 million, compared to $26.5 million for the year ended December 31, 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.
Gross Profit: Gross profit for the year ended December 31, 2023, was $3.6 million with a gross margin of 19.1%, compared to $13.2 million with a gross margin of 49.7% in the prior year period. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.
Expenditures:
Research and development expenses for the year ended December 31, 2023, were $7.5 million compared to $10.2 million in the prior year.
Selling, general, and administrative expenses for the year ended December 31, 2023, were $11.6 million, compared to $10.6 million in the prior year.
Operating Results: Operating loss for the year ended December 31, 2023, was $15.3 million, compared to an $8.3 million loss in the year ended December 31, 2022.
Net Loss: Net loss in the year ended December 31, 2023 was $6.7 million or $0.75 per share, compared to the net loss of $19.6 million, or $3.93 per share for the year ended December 31, 2022.
Non-GAAP Adjusted EBITDA: Adjusted EBITDA for the year ended December 31, 2023 was a loss of $12.3 million, compared to a loss of $4.4 million for the year ended December 31, 2022.
Balance Sheet Highlights
As of December 31, 2023, the Company’s cash, restricted cash, and investments were $42.1 million, compared to $34.1 million reported on December 31, 2022. In the first quarter of 2023, the Company raised a gross amount of $27.5 million through a registered direct offering. The company used $17.1 million to fund its activities. The existing cash and restricted cash, and investments will provide sufficient funds through profitability.
Conference Call
MediWound management will host a conference call for investors on Thursday, March 21, 2024, 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 1-833-630-1956 (in the U.S.), 1-80-921-2373 (Israel), or 1-412-317-1837 (outside the U.S. & Israel). The call will be available via webcast by clicking HERE or on the Events & Presentations page of Company’s website.
A replay of the call will be available on the Company’s website at www.mediwound.com.
Non-IFRS Financial Measures
To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company’s performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and share-based compensation expenses.
Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our senior management.
However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company’s operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below.
About MediWound
MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The Company specializes in the development, production and commercialization of solutions that seek to improve existing standards of care. MediWound is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries.
MediWound’s first drug, NexoBrid®, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant potential advantages over the $360 million dominant product and an opportunity to expand the market. MediWound’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a Phase I/II study.
For more information visit www.mediwound.com and follow the Company on LinkedIn and X.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions 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, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx® and NexoBrid®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 21, 2024 and 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:
Hani Luxenburg
Daniel Ferry
Chief Financial Officer
Managing Director, LifeSci Advisors
MediWound Ltd.
617-430-7576
ir@mediwound.com
daniel@lifesciadvisors.com
Media Contact:
Ellie Hanson
FINN Partners for MediWound
ellie.hanson@finnpartners.com
929-588-2008
MediWound, Ltd.
Audited Condensed Consolidated Statements of Financial Position
U.S. dollars in thousands
Dec 31,
2023
2022
CURRENT ASSTS:
Cash and cash equivalents and short-term deposits
41,708
33,895
Trade and other receivable
5,141
9,982
Inventories
2,846
1,963
Total current assets
49,695
45,840
Non-current assets
Other receivables
673
364
Property, plant and equipment, net
9,228
2,366
Right of use assets, net
6,698
1,215
Intangible assets, net
165
231
Total non-current assets
16,764
4,176
Total assets
66,459
50,016
CURRENT LIABILITIES:
Current maturities of long-term liabilities
1,410
2,242
Trade payables and accrued expenses
5,528
5,656
Other payables
3,891
4,159
Total current liabilities
10,829
12,057
Warrants, net
7,296
15,606
Liabilities in respect of IIA grants
7,677
7,445
Liability in respect of TEVA
2,256
2,788
Lease liabilities
6,350
846
Severance pay liability, net
456
360
Total non-current liabilities
24,035
27,045
Shareholders' equity
31,595
10,914
Total liabilities & equity
66,459
50,016
MediWound, Ltd.
Audited Condensed Consolidated Statements of Profit or Loss and Other Comprehensive Income or Loss
U.S. dollars in thousands (except of share and per share data)
Twelve months ended
Three months ended
Dec 31,
Dec 31,
2023
2022
2023
2022
Total Revenues
18,686
26,496
5,338
11,618
Cost of revenues
15,108
13,331
4,619
3,460
Gross profit
3,578
13,165
719
8,158
Research and development
7,467
10,181
1,808
2,699
Selling and Marketing
4,844
3,725
1,209
692
General and administrative
6,768
6,920
1,583
2,269
Other (Income) expenses
(211)
684
13
375
Operating loss
(15,290)
(8,345)
(3,894)
2,123
Financial income (expenses), net
8,759
(11,176)
2,271
(9,515)
Taxes on income
(185)
(78)
(120)
(65)
Net loss
(6,716)
(19,599)
(1,743)
(7,457)
Foreign currency translation adjustments
(13)
14
(11)
(20)
Total comprehensive loss
(6,729)
(19,585)
(1,754)
(7,477)
Basic and diluted loss per share:
Net loss per share
(0.75)
(3.93)
(0.19)
(1.18)
Weighted average number of ordinary shares
9,013,144
4,987,069
9,219,923
6,332,981
MediWound, Ltd.
Audited Condensed Consolidated Statements of Cash Flows
U.S. dollars in thousands
Twelve months ended
Three months ended
Dec 31,
Dec 31,
2023
2022
2023
2022
Audited
Unaudited
Cash Flows from Operating Activities:
Net Loss
(6,716)
(19,599)
(1,743)
(7,457)
Adjustments to reconcile net loss to net cash used in operating activities:
Adjustments to profit and loss items:
Depreciation and amortization
1,303
1,272
346
284
Share-based compensation
1,940
1,946
298
642
Revaluation of warrants accounted at fair value
(8,310)
8,977
(1,603)
8,977
Issuance expenses of warrants through profit and loss
-
1,911
-
1,523
Revaluation of liabilities in respect of IIA grants
427
(132)
(282)
(944)
Revaluation of liabilities in respect of TEVA
468
533
111
129
Financing income and exchange differences of lease liability
257
(109)
463
37
Increase in severance liability, net
83
109
3
45
Other income
(211)
-
13
-
Financial income, net
(2,231)
(74)
(836)
(408)
Un-realized foreign currency loss (gain)
189
525
(347)
60
(6,085)
14,958
(1,834)
10,345
Changes in asset and liability items:
Decrease (increase) in trade receivables
5,658
(7,582)
(528)
(5,137)
Decrease (increase) in inventories
(906)
(721)
782
(113)
Decrease (increase) in other receivables
(894)
364
(696)
221
Increase (decrease) in trade payables and accrued expenses
(594)
414
1,093
784
Increase (decrease) in other payables
(928)
281
311
2,107
2,336
(7,244)
962
(2,138)
Net cash used in operating activities
(10,465)
(11,885)
(2,615)
750
MediWound, Ltd.
Audited Condensed Consolidated Statements of Cash Flows
U.S. dollars in thousands
Cash Flows from Investing Activities:
Purchase of property and equipment
(6,464)
(555)
(2,209)
(174)
Interest received
1,947
74
722
71
Proceeds from (Investment in) short term bank deposits, net
(29,804)
-
6,515
2,499
Net cash used in investing activities
(34,321)
(481)
5,028
2,396
Cash Flows from Financing Activities:
Repayment of lease liabilities
(778)
(701)
(204)
(170)
Proceeds from issuance of shares and warrants, net
24,909
38,390
-
16,475
Repayments of IIA grants, net
(380)
(258)
-
-
Repayment of liabilities in respect of TEVA
(834)
(1,667)
-
(417)
Net cash provided by (used in) financing activities
22,917
35,764
(204)
15,588
Exchange rate differences on cash and cash equivalent balances
(160)
(549)
378
(44)
Increase (decrease) in cash and cash equivalents
(22,029)
22,849
2,587
18,990
Balance of cash and cash equivalents at the beginning of the period
33,895
11,046
9,279
14,905
Balance of cash and cash equivalents at the end of the period
11,866
33,895
11,866
33,895
MediWound, Ltd.
Adjusted EBITDA
U.S. dollars in thousands
Twelve months ended
Three months ended
Dec 31,
Dec 31,
2023
2022
2023
2022
Net loss
(6,716)
(19,599)
(1,743)
(7,457)
Adjustments:
Financial income (expenses), net
8,759
(11,176)
2,271
(9,515)
Other (Income) expenses, net
211
(684)
(13)
(375)
Taxes on income
(185)
(78)
(120)
(65)
Depreciation and amortization
(1,303)
(1,272)
(346)
(284)
Share-based compensation expenses
(1,940)
(1,946)
(298)
(642)
Total adjustments
5,542
(15,156)
1,494
(10,881)
Adjusted EBITDA
(12,258)
(4,443)
(3,237)
3,424
midastouch017
4 months ago
MediWound Secures Additional U.S. Department of Defense Funding to Advance NexoBrid® Development for the U.S. Army
https://finance.yahoo.com/news/mediwound-secures-additional-u-department-120000363.html
Awarded additional $6.7 million to advance NexoBrid as a non-surgical field care solution; R&D project budget increased to $14.4 million
YAVNE, Israel, Dec. 28, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Department of Defense (DoD), through the Medical Technology Enterprise Consortium (MTEC), has awarded MediWound an additional $6.7 million in non-dilutive funding to develop NexoBrid® as a non-surgical solution for field-care burn treatment for the U.S. Army (the "MTEC Research Project Award"). The $14.4 million project budget will advance the development and production of a new, temperature-stable formulation of NexoBrid, positioning it as the first-line non-surgical solution for treating severe burn injuries in pre-hospital settings. Vericel Corporation holds an exclusive license encompassing the commercial and development rights to NexoBrid in North America as set forth in the license agreement between the Company and Vericel.
"We are delighted to further solidify our partnership with the U.S. Department of Defense. The additional funding will enhance our CMC activities, expedite preclinical development, and facilitate the establishment of a GMP compliant aseptic production line for the temperature-stable formulation of NexoBrid," announced Ofer Gonen, Chief Executive Officer of MediWound. "This new award underscores our shared commitment to ensuring NexoBrid's availability for military use and its potential to significantly change the early treatment approach for severe burns."
The MTEC Research Project Award was granted by the DoD’s U.S. Army Medical Research and Development Command (USAMRDC) and funded by the Defense Health Agency through MTEC, a biomedical technology consortium working to advance innovative medical solutions to keep military personnel healthy and fully operational. In alignment with this mission, it's vital to have field solutions for severe burn treatments that are both easy-to-use and effective. Such solutions should be applicable immediately post-injury and demand minimal preparation and training.
About U.S. Army Medical Research and Development Command (USAMRDC)
The U.S. Army Medical Research and Development Command is the Army’s medical materiel developer, with responsibility for medical research, development, and acquisition. USAMRDC produces medical solutions for the battlefield with a focus on various areas of biomedical research, including military infectious diseases, combat casualty care, military operational medicine, medical chemical, and biological defense https://mrdc.health.mil/.
Please note, the views expressed in this press release are those of MediWound and may not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.
About Medical Technology Enterprise Consortium (MTEC)
The Medical Technology Enterprise Consortium is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement with the U.S. Army Medical Research and Development Command. The consortium focuses on the development of medical solutions that protect, treat, and optimize the health and performance of U.S. military personnel. To find out more about MTEC, visit mtec-sc.org.
About MediWound
MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries.
MediWound’s first drug, NexoBrid®, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. MediWound’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a recently completed Phase I/II study.
For more information visit www.mediwound.com and follow the Company on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions 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, study design, expected data timing, objectives, anticipated timelines, expectations and commercial potential of our products and product candidates, including NexoBrid. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the U.S. food and Drug Administration or any other regulatory authority; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and product candidates; our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and 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, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, 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.
MediWound Contacts:
Hani Luxenburg
Daniel Ferry
Chief Financial Officer
Managing Director
MediWound Ltd.
LifeSci Advisors, LLC
ir@mediwound.com
daniel@lifesciadvisors.com
midastouch017
5 months ago
MediWound Receives Positive CHMP Opinion Recommending Approval for NexoBrid® to Treat Pediatric Patients
https://finance.yahoo.com/news/mediwound-receives-positive-chmp-opinion-120000725.html
The label expansion will solidify NexoBrid’s position in the EU as a safe and effective non-surgical treatment for burn patients of all ages
YAVNE, Israel, Nov. 13, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending a change to the terms of the marketing authorization for NexoBrid in Europe to include all age groups for removal of eschar in patients with deep partial- and full-thickness thermal burns. The CHMP positive opinion is pending a decision by the European Commission, which is expected imminently.
This positive opinion is based on the results of a global Phase 3 trial that evaluated the safety and efficacy of NexoBrid in hospitalized pediatric patients (CIDS study), funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. It is also supported by additional pediatric data available from Phase 3 and Phase 2 studies conducted during the clinical development of NexoBrid.
The Phase 3 study met its three primary endpoints with a high degree of statistical significance. NexoBrid demonstrated a significant reduction in the time to achieve complete eschar removal and a significant reduction in the wound area requiring surgical excision (surgical need) while demonstrating non-inferiority to SOC in quality of scars as measured by MVSS. The study also met certain secondary endpoints showing statistically significant reduction in the incidence of surgical excision and a reduction in the need for autograft in deep partial burns, as well as a favorable trend in the reduction of blood loss during the eschar removal process. In addition, the study confirmed NexoBrid to be safe and well-tolerated for all ages.
“This significant milestone advances our goal to redefine the standard of care for the treatment of severe burns. The current standard, surgery, is extremely traumatic to both patients and their families. NexoBrid offers a safe, fast, and highly effective debridement alternative to surgery, minimizing blood loss and reducing the time required for treatment,” said Ofer Gonen, CEO of MediWound. He added, “From a commercial perspective, pediatric burn victims comprise more than 30% of the total burn population making this new indication a significant addition to our addressable market.”
About NexoBrid
NexoBrid® is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and/or full-thickness thermal burns without harming viable tissue. NexoBrid is approved in over 40 countries, including in United States, European Union and Japan, where it has been designated as an orphan biologic drug.
NexoBrid development has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, under contract HHSO100201500035C. This contract provided funding and technical support for the pivotal U.S. Phase 3 clinical study (DETECT), the randomized, controlled pivotal clinical trial for use in the pediatric population (CIDS), the marketing approval registration process for NexoBrid as well as its procurement and availability under the expanded access treatment protocol (NEXT) in the U.S. Additional projects for evaluation of NexoBrid funded under the BARDA contract include 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.
About MediWound
MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries.
MediWound’s first drug, NexoBrid®, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. MediWound’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a recently completed Phase I/II study.
For more information visit www.mediwound.com and follow the Company on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions 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, expectations and commercial potential of our products and product candidates, including NexoBrid®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated our expectations regarding future growth, market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates 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, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 16, 2023 and 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.
MediWound Contacts:
Hani Luxenburg
Daniel Ferry
Chief Financial Officer
Managing Director
MediWound Ltd.
LifeSci Advisors, LLC
ir@mediwound.com
daniel@lifesciadvisors.com
midastouch017
6 months ago
MediWound Announces Collaboration with 3M on EscharEx® Phase III Study
https://finance.yahoo.com/news/mediwound-announces-collaboration-3m-escharex-100000502.html
MediWound to join forces with 3M Health Care, world’s largest wound care company in pivotal study for patients with venous leg ulcers
YAVNE, Israel, Oct. 11, 2023 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation enzymatic therapeutics for tissue repair, today announced collaboration with 3M Health Care. 3M Health Care will provide its market leading two-layer compression systems Coban™ 2 and Coban™ 2 Lite to be used during the debridement and wound healing phases of the EscharEx Phase III study.
"In our pursuit of excellence, one primary aim is to ensure consistency across subjects while delivering optimal care throughout the study. 3M Health Care's Coban™ compression systems stand out as global market leaders, and we're pleased to designate them as the standard for our Phase 3 study," commented Ofer Gonen, Chief Executive Officer of MediWound. "Given that compression therapy is pivotal in managing venous leg ulcers (VLUs), it's imperative that we employ top-tier products. With 3M Health Care’s two-layer compression systems, we're confident we're doing just that."
EscharEx is being evaluated for efficacy and safety in the debridement of chronic wounds, with the first indication being VLUs. During the debridement phase, as well as in the wound healing phase of the study, 3M’s two-layer compression systems will be used as standard of care in all study arms, until the wounds reach complete healing.
"We are excited to partner with MediWound on this pivotal Phase III study. Establishing Coban™ 2 and Coban™ 2 Lite as the benchmark in compression therapy underscores the brand's leadership and reinforces its position as the top choice for VLU patients," said Rob Steel, Global Portfolio Director at 3M Health Care. "We anticipate leveraging the comprehensive data from the study to convey to clinicians and payors the clinical and economic advantages of our compression systems."
About EscharEx
EscharEx® (concentrate of proteolytic enzymes enriched in bromelain) is a topical biologic drug applied daily that enzymatically removes nonviable wound tissue, or eschar, in patients with chronic wounds without harming viable tissue. EscharEx has been the subject of 3 successful Phase 2 studies, and is entering into a global Phase III study in early 2024. Co-primary endpoints in the study are incidence of complete debridement and time to complete wound closure. Secondary endpoints include time to complete debridement, incidence of complete granulation tissue, incidence of complete wound closure and wound area reduction.
About 3M
3M (NYSE: MMM) believes science helps create a brighter world for everyone. By unlocking the power of people, ideas and science to reimagine what's possible, our global team uniquely addresses the opportunities and challenges of our customers, communities, and planet. Learn how we're working to improve lives and make what's next at 3M.com/news or on Twitter at @3M or @3MNews.
About MediWound Ltd.
MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. Specializing in the development, production and commercialization of solutions that seek to replace existing standards of care, the Company is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries.
MediWound’s first drug, NexoBrid®, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant advantages over the $300 million monopoly legacy drug and an opportunity to expand the market. MediWound’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a recently completed Phase I/II study.
For more information visit www.mediwound.com and follow the Company on LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions 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, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; the impact of the COVID-19 pandemic, our expectations regarding future growth, including our ability to develop new products; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates 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, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 16, 2023 and 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.
MediWound Contacts:
Hani Luxenburg
Daniel Ferry
Chief Financial Officer
Managing Director
MediWound Ltd.
LifeSci Advisors, LLC
ir@mediwound.com
daniel@lifesciadvisors.com
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