Website Notice Block
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16 of the
Securities Exchange Act of 1934
Securities Exchange Act of 1934
For the month of July 2022
Commission File Number: 001-36349
MediWound Ltd.
(Translation of registrant’s name into English)
(Translation of registrant’s name into English)
42 Hayarkon Street
Yavne, 8122745 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule
101(b)(1): __
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule
101(b)(7): __
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On July 12, 2022, MediWound Ltd. (the “Company”) presented certain market research during a KOL event and made
available the presentation on its website. A copy of the presentation is attached hereto as Exhibit 99.1. The fact that the presentation is being made available and furnished herewith is not an admission as to the materiality of any information
contained in the presentation. The information contained in the presentation is being provided as of July 12, 2022 and the Company does not undertake any obligation to update the presentation in the future or to update forward-looking statements to
reflect subsequent actual results.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly authorized.
| MEDIWOUND LTD. | |||
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Date: July 12, 2022
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By:
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/s/ Boaz Gur-Lavie | |
| Name: Boaz Gur-Lavie | |||
| Title: Chief Financial Officer | |||
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EXHIBIT INDEX
The following exhibit is filed as part of this Form 6-K:
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Exhibit
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Description
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Exhibit 99.1
Market Landscape Analysis & EscharEx Market PotentialKevin FengOliver Wyman
In-depth interviews (N=30) with KOLs, community practitioners, payers in US / EU Current & future
treatment dynamics Feedback on EscharEx profile and positioning Pharmacoeconomic considerations Web survey (N=200) fielded to quantify the opportunity for modeling (e.g. eligibility rate, tx rate, shares, etc.) In-depth interviews with VLU
treaters (2020) across diverse specialties to reflect range of treaters that see VLU patients (N=10, 45 min each) Interviewees represented diverse geographic mix across the US Discussion focused on clinical and commercial topics of interests
related to the evaluation of EscharEx potential Performed market sizing analysis for VLUs and DFUs Triangulated estimates across range of sources including literature, syndicated market research, and analyst reports Performed analog research
to identify benchmarks to guide time to peak adoption estimates Created a 10-year forecast for EscharEx in VLUs and DFUs EscharEx market share estimates were based on prior rounds of market research Output included VLU and DFU revenue
estimates building to total EscharEx market potential In-depth interviews with VLU / DFU treaters (2022) across specialties, including both Study PIs & EscharEx-naïve treaters (N=12, 45 min each) Discussion focused on evaluating potential
for EscharEx based on latest Phase 2 results Updated forecast for EscharEx, integrating new findings from MR with prior rounds of research Market Research Has Been Comprehensive 2015 2020 2020 2022 2020 Comprehensive and step-wise
evaluation of EscharEx Potential based on latest clinical development plan & data
Chronic Wound Patient Journey: Key Sites of Care Community patients may see home care nurse before wound
is severe enough to be referred to clinic Outpatient Clinic Follow Up: Avg. 1-3X per week; majority receive home care follow up Hospital Inpatient (<15%*) Length of Stay: Avg. 1-2 weeks Treaters: Variable; more access to surgical
specialists Home Care, Nursing Homes, & Long Term Care Majority of chronic wound patients require long-term follow-up care at home / nursing facility Initial Follow Up: Avg. once every 2-3 days Treaters: Community / home care
nurses Majority of chronic wounds present outpatient GP / PCP Hospital Units Chronic Wound Patient Also: general podiatry, diabetology, dermatology, vascular surgery Wound Care Clinic Treaters: Rotating panel of ~4-5 specialties or one
specialized physician Most wound care in US; etiology-specific clinics also exist Home Care Nurse DFU or Leg Ulcer Clinic Treaters: ~2-4 diabetologists / podiatrists (DFUs) OR dermatologists / surgeons (VLUs); several nurses A subset are
triaged inpatient due to severity (need for surgical intervention), infection Majority Minority Most chronic wounds in the U.S. are treated outpatient with follow-up visits 1-3x per week *15% present in academic setting w/ more complex
wounds; overall % inpatient likely lower
Debridement is SOC, But Method Is Not Standardized Thorough Patient History Rule out infection, x-ray
or culture if needed Assess perfusion / blood flow Assess need for debridement Basic Wound Work-Up Advanced Wound Care Debridement needed (~70% DFUs, ~55% VLUs) Debridement not needed (~30% DFUs, ~45% VLUs) Autolytic (± Sharp) Enzymatic
(± Sharp) Mechanical Surgical Other (Ultrasound, Larvae) Jet Lavage / Hydrosurgery Continue TIME Framework MajorityMinority < 50% healing after 4 wks Debridement Selection Process ** Specialized centers only Wound characteristics
(e.g. complications) Efficacy / outcomes Patient considerations (e.g. tolerability) Site of care Skill of practitioner required (i.e. training) Time and/or frequency of debridement Cost & reimbursement Input of other HCPs involved in
patient care Factors Determining Choice of Debridement Method Decreasing Frequency of Use START Sharp (Bedside), Alone Debridement Method Selection Decreasing Importance Wound characteristics, efficacy, and patient considerations are top
influencers of choice
2022 US DFU Epidemiology Estimate 2022 US VLU Epidemiology Estimate Triangulation Indicates 1M VLUs and
1.1M DFUs Annually Eligible for Debridement 1.1M active DFUs in a given year 70% of DFUs undergo debridement 770K DFUs undergoing debridement in a given year Millions of Patients 1.0M incident patients with an active VLU, eligible for
tx 55% of DFUs undergo debridement 560K VLUs undergoing debridement in a given year
*Estimates are based on small study (N=12) VLU Debridement Approach Driven By Site Of Care; Sharp
Remains SoC Across Wound Care Clinics Current Debridement Practices* Commentary “All DFU / VLU patients get sharp debridement. If they are able to tolerate it, it is probably the most effective debridement method of removing nonviable
tissue, as well as bioburden in the wound. ” – Podiatrist #5 (Non-PI) 29% 29% Legend “Some of the wounds are more superficial, sometimes the topical agent alone is enough...if they are not responding, yeah, then we would have to step it up
and go to a different method, probably add sharp debridement in ” – Dermatologist #2 (Non-PI) Source: OW Primary Research (6/2022) All VLU patients seen at WC clinics will undergo debridement In contrast, in home health setting only 1/3
VLUs are debrided; other 2/3 of patients have wounds that are caught and managed early by nurses, and thus can heal without needing debridement Choice of debridement technique is highly dependent on site of care Surgeons and clinicians at
wound care clinics, regardless of medical specialty, perform sharp debridement as SOC for all patients In other specialty practices, such as dermatology, clinicians much more split between sharp vs. non-sharp Nursing home / home health
settings depend enzymatic or autolytic While sharp is SoC at WC clinics, pain can be a barrier to use (particularly in VLUs), leading HCPs to defer to a topical instead Sharp + enzymatic / autolytic combinations are also commonly used, with
sharp used as primary method (e.g. 1-2x per week) and topical as maintenance (applied in between sharp visits)
Current Enzymatic Use is Limited, Due to Perception of Low Efficacy and High Cost Current Enzymatic SOC
Perception Commentary Efficacy Less Favorable More Favorable Safety Less Favorable More Favorable Dosing & Administration Less Favorable More Favorable Cost Less Favorable More Favorable Efficacy: HCP opinion of enzymatic
efficacy generally ranges from very low to moderate; most still utilize to some degree but note limited efficacy due to slow speed of debridement Efficacy may be further reduced if unable to comply with recommended 1x daily regimen A few HCPs
cited Panafil as a much faster enzymatic debrider, prior to recall Safety: Considered very safe, with minimal AEs / pain Dosing & Administration: Generally considered easy to use / apply, given potential for self or care-giver
application; recommended regimen is typically 1x / day Slow speed of debridement leads to extended use (average of 6-8 weeks), which can also influence patient compliance with daily regimen Cost: High cost often cited as major disadvantage
relative to efficacy, Average cost of ~$298 / 30g tube, reimbursed under pharmacy benefit; prior research showed patients use ~6-8 tubes on average (total cost of treatment ~$2000) “Enzymatic use is a little bit of an expense thing. It is a
little bit of an availability thing that sometimes it is just harder to get, so that I use them less partly for that reason. I do think they probably work a little bit better than autolytic, but I am not honestly even sure of that.” –
Dermatologist #2 (Non-PI) “It is efficacious compared to Vaseline... But is it tremendously efficacious? Tremendously helpful? I question that notion… Oftentimes, my patients cannot afford it, or the patient has to pay most of it because their
prescription plan may or may not cover it.” – Podiatrist #2 (Non-PI) Source: OW Primary Research (6/2022)
Physicians note that while sharp is efficacious and affordable, there remain situations where sharp
cannot be utilized, driving unmet need for efficacious and affordable non-sharp alternatives: Speed: Ideal product should work faster than current topical modalities, as speed of debridement cited by most HCPs as greatest unmet
need Affordability: Novel agent should be affordable and similar to current alternatives; experts note higher cost or lack of coverage by insurance as deterrents to using current modalities Application frequency / duration: Daily application
over long periods of time required by current enzymatic treatment; alternative ideally requires fewer applications Gap in market remains after recall of papain products (seen as much more effective than current enzymatic SoC), which were used
commonly when sharp was not suitable A few physicians have noted interest in few products in the pipeline (e.g. hydro-debriders, topical stem cell agents); however, most HCPs have limited optimism or knowledge of therapeutic agents in the
pipeline HCPs Report Significant Need For Faster, More Efficacious Topical Debridement Agent “I would like to see a product that actually works within a reasonable period of time. Not eight weeks but maybe something within four weeks. Even
with compliant patients with a wound that’s a couple centimeters in diameter, it’s going to take eight weeks. It shouldn’t take that long. –Podiatrist #1 (Non-PI) “Enzymatic is not great at debriding everything and it takes a long time
…something that will debride faster is what we are looking for. Sharp is really the only fast debridement modality, but it is not always applicable. If we had something that was able to debride the wound faster without causing pain, that would
be ideal.” –Podiatrist #4 (PI) Source: OW Primary Research (6/2022) Unmet Need Pipeline
EscharEx Perceived As Highly Efficacious, Demonstrating Clear Benefit Over Current Options EscharEx
Perception by Attribute Perception of efficacy is extremely favorable, with HCPs immediately noting EscharEx’s faster speed of debridement vs. current agents Primary and secondary clinical endpoints believed to be most important, with
clearest benefit demonstrated by incidence of and time needed to achieve complete debridement Pharmacology data seen as helpful in supporting clinical endpoints, though less important than primary / secondary HCPs often expect lower biofilm /
bacterial load as natural consequence of better debridement (and thus may not emphasize importance of seeing pharmacology data) However, a few physicians noted biofilm score / bacterial load has been emerging with increasing level of
importance in wound healing field Few HCPs want to see superior efficacy in wound closure, given faster debridement should translate to faster wound closure; however, most believe that a superiority endpoint is not essential for a debridement
agent, and comparable incidence / time data is sufficient If superior efficacy for wound closure was shown, HCPs believe this may support even further adoption of Product X and justify higher costs “The product looks like it works very well.
They are basically saying you only need five applications of this product to get the wound to a granular bed, which is great because you do not usually see that.” –Podiatrist #5 (PI) “I think biofilm is increasingly important because of
literature supporting better ways of trying to break bioburden down. It is more on my radar today than it was 10 years ago or even two years ago. It’s innovative in a way to keep that as one of your endpoints. ” –Podiatrist #6 (PI) Primary
Endpoint Incidence to complete debridement Secondary Endpoint Time to achieve complete debridement # applications needed for debridement >75% Granulation tissue incidence Pharmacology Biofilm Score Bacterial load via
fluorescence Wound Closure Incidence of wound closure Time to wound closure Source: OW Primary Research (6/2022) Commentary Efficacy Less Favorable More Favorable Less Important More Important Relative Importance to Profile
Minimal Issues with EscharEx Safety Or Dosing & Administration “My perception wouldn’t change from 5
to 8 applications. I mean current enzymatic treatment, it’s 100 applications, you know. So, they could go to 20 applications, and it still wouldn’t make any difference to me.” –Dermatologist #2 (Non-PI) “There were no adverse events. There
were no allergic reactions to the product. It seems like it is a safe product to use. 120 patients to evaluate the tolerability and safety of the product, it is a good study. ” –Podiatrist #5 (PI) Source: OW Primary Research
(6/2022) EscharEx Perception by Attribute Commentary Safety Less Favorable More Favorable Dosing & Administration Less Favorable More Favorable Safety: Most HCPs raised minimal issues with safety profile (perceiving as safe), with
several noting how crucial safety is when considering high opinion of enzymatic agent’s safety today A few HCPs requested additional data surrounding pain (or absence of pain) upon application, highlighting importance of patient
comfort Dosing & Administration: Perceived as favorable, particularly given short regimen (daily applications for 5 days) compared to current enzymatic agent and potential for home-application Potential for range of 5-8 applications did
not raise any concerns, as even 8 days is significantly faster than current enzymatic agent; few HCPs noted minor benefit with 7 or fewer days, to fit logistically into weekly clinical visits HCPs also amenable to first application in clinic,
followed by subsequent home applications
Given Strong Profile of EscharEx, HCPs Reported Expansion of Enzymatic Use Drawing From Other
Classes Future Debridement Practices HCPs expect aggressive expansion of enzymatic segment across VLUs & DFUs, with slightly higher use in VLUs given additional barrier that pain poses to sharp use; similarly, HCPs expect greater use of
enzymatic only in VLUs (vs. DFUs), but greater use of sharp + enzymatic in DFUs (vs. VLUs) VLU DFU Legend 29% 55% 29% 52% Source: OW Primary Research (6/2022) EscharEx is anticipated to draw share from all other debridement modalities
(including sharp only, autolytic only, and sharp + autolytic)
~2.1M VLU and DFU patients eligible for debridement in a given year 55% - 70% Percentage of wounds
debrided 43% Percentage debrided by enzymatic methods (Research indicates that EscharEx can expand enzymatic market (~20% debrided by enzymatic methods today) if superior to current enzymatic agent and more cost effective) 70% Anticipated
EscharEx market share based on superiority 5 Years-to-Peak Share CoT: $1,500 (base) / $1,800 (upside) / $1,200 (downside) CoT: based on 5 applications on average @ $300 per application U.S. Market Opportunity EscharEx TAM for VLUs and
DFUs is estimated at ~$2B in the U.S. Market research and physician feedback suggest that EscharEx potential market share at ~30% Market potential estimates based on above assumptions, and does not account for market access and other
considerations that may impact actual figures and are subject to EscharEx approval b FDA. EscharEx is an investigational drug under development, not approved in any jurisdiction