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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
______________________
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16 of the
Securities Exchange Act of 1934
For the month of June 2015
Commission File Number: 001-36349
MediWound Ltd.
(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 x Form 40-F o
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): __
EXPLANATORY NOTE
Gal Cohen, President and Chief Executive Officer of MediWound Ltd. (the “Company”) and Sharon Malka, Chief Financial Officer of the Company will deliver the Company’s corporate presentation at the Jefferies 2015 Global Healthcare Conference on Thursday, June 4, 2015 at 09:00 a.m. Eastern Time. The Company’s presentation will be webcast live on the internet and can be accessed by visiting the Investor Relations section of the Company’s website at www.mediwound.com. A replay of the webcast will be archived on the MediWound website for 90 days following the presentation. Materials to be used in conjunction with the presentation are furnished as Exhibit 99.1 to this Form 6-K and are available on the Company’s website at www.mediwound.com.
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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.
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MEDIWOUND LTD.
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Date: June 4, 2015
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By: |
/s/ Sharon Malka
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Name: Sharon Malka
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Title: Chief Financial Officer
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EXHIBIT INDEX
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Exhibit
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Description
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99.1
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MediWound presentation materials for Jefferies 2015 Global Healthcare Conference.
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Exhibit 99.1
June 2015
§ This presentation contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934,
as amended and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. We make forward-looking statements in this presentation that are subject to risks and
uncertainties. These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and
objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,”
“predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements reflect our current views with respect to future events and are based on
assumptions and subject to risks and uncertainties. You should not unduly rely on any forward-looking statements. Although we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or
will occur. The statements we make regarding the following matters are forward-looking by their nature: the timing and conduct of our trials of NexoBrid and our other pipeline product
candidates, including statements regarding the timing, progress and results of current and future preclinical studies and clinical trials, and our research and development programs; the clinical
utility, potential advantages and timing or likelihood of regulatory filings and approvals of NexoBrid and our pipeline products; our expectations regarding future growth, including our ability to
develop new products; our commercialization, marketing and manufacturing capabilities and strategy and the ability of our marketing team to cover regional burn centers and units; our ability to
maintain adequate protection of our intellectual property; our plans to develop and commercialize our pipeline products; our estimates regarding expenses, future revenues, capital requirements
and the need for additional financing; our estimates regarding the market opportunity for NexoBrid and our pipeline products; our expectation regarding the duration of our inventory of
intermediate drug substance and products; the impact of our research and development expenses as we continue developing product candidates; our expectations regarding the time during
which we will be an emerging growth company under the JOBS Act and the impact of government laws and regulations. Please refer to other factors discussed under the heading “Risk Factors” in
the U.S. Annual Report on the Form 20-F for the year ended December 31, 2014 filed with the U.S. Securities and Exchange Commission on February 12, 2015 and other documents filed with or
furnished to the U.S. Securities and Exchange Commission. Any forward-looking statement made in this presentation speaks only as of the date hereof. Although we believe that the expectations
reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking
statements will be achieved or will occur. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this
presentation, to conform these statements to actual results or to changes in our expectations
as amended and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. We make forward-looking statements in this presentation that are subject to risks and
uncertainties. These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and
objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,”
“predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements reflect our current views with respect to future events and are based on
assumptions and subject to risks and uncertainties. You should not unduly rely on any forward-looking statements. Although we believe that the expectations reflected in the forward-looking
statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or
will occur. The statements we make regarding the following matters are forward-looking by their nature: the timing and conduct of our trials of NexoBrid and our other pipeline product
candidates, including statements regarding the timing, progress and results of current and future preclinical studies and clinical trials, and our research and development programs; the clinical
utility, potential advantages and timing or likelihood of regulatory filings and approvals of NexoBrid and our pipeline products; our expectations regarding future growth, including our ability to
develop new products; our commercialization, marketing and manufacturing capabilities and strategy and the ability of our marketing team to cover regional burn centers and units; our ability to
maintain adequate protection of our intellectual property; our plans to develop and commercialize our pipeline products; our estimates regarding expenses, future revenues, capital requirements
and the need for additional financing; our estimates regarding the market opportunity for NexoBrid and our pipeline products; our expectation regarding the duration of our inventory of
intermediate drug substance and products; the impact of our research and development expenses as we continue developing product candidates; our expectations regarding the time during
which we will be an emerging growth company under the JOBS Act and the impact of government laws and regulations. Please refer to other factors discussed under the heading “Risk Factors” in
the U.S. Annual Report on the Form 20-F for the year ended December 31, 2014 filed with the U.S. Securities and Exchange Commission on February 12, 2015 and other documents filed with or
furnished to the U.S. Securities and Exchange Commission. Any forward-looking statement made in this presentation speaks only as of the date hereof. Although we believe that the expectations
reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking
statements will be achieved or will occur. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this
presentation, to conform these statements to actual results or to changes in our expectations
§ The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of the products or services
of the Company.
of the Company.
§ Certain data in this presentation was obtained from various external sources, and neither the Company nor its affiliates, advisers or representatives has verified such data with independent
sources. Accordingly, neither the Company nor any of its affiliates, advisers or representatives makes any representations as to the accuracy or completeness of that data or to update such data
after the date of this presentation. Such data involves risks and uncertainties and is subject to change based on various factors.
sources. Accordingly, neither the Company nor any of its affiliates, advisers or representatives makes any representations as to the accuracy or completeness of that data or to update such data
after the date of this presentation. Such data involves risks and uncertainties and is subject to change based on various factors.
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§ Fully integrated, biopharmaceutical company developing,
manufacturing and commercializing novel products for wound
and burn care management
manufacturing and commercializing novel products for wound
and burn care management
§ Strong proprietary proteolytic enzymes technology:
§ NexoBrid®: severe burn wounds
§ Launched, innovative, orphan, biological drug indicated for eschar
removal of deep partial and full thickness burns
§ EscharEx™: chronic and hard to heal wounds
§ MWPC003: connective tissue disorders
§ State of the art, EMA certified, cGMP compliant manufacturing
facility for sterile pharmaceutical products
facility for sterile pharmaceutical products
§ Committed management team with decades of industry
experience
experience
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OUR LEAD PRODUCT
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Pre-clinical
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Phase 1
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Phase 2
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Phase 3
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Approved
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Product
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Indication
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NexoBrid
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Severe burns
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EscharEx
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Chronic
wounds |
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MWPC003
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Connective
tissue disorders |
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US Phase 3 study
2nd Phase 2 study
Ex-vivo results
Launched in Europe
EU Paediatric study
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§ ~200,000 hospitalized
patients every year in
EU and US
patients every year in
EU and US
§ Prevalence higher in
emerging economies
(e.g. 400,000 patients
every year in India)
emerging economies
(e.g. 400,000 patients
every year in India)
§ Broad addressable
population of more than 14
million patients in US and EU
§ Includes patients with
diabetic/pressure/ venous
ulcers and post-surgery/
diabetic/pressure/ venous
ulcers and post-surgery/
trauma hard-to-heal wounds
§ Dupuytren’s disease:
~6.2 million patients in
the US alone
~6.2 million patients in
the US alone
§ Peyronie’s disease:
~3-7% of the male
population above 50 in
the US and EU
~3-7% of the male
population above 50 in
the US and EU
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Before…
Eschar
Subcutaneous
fat
fat
Dermis
§ Prevents local infection and sepsis
§ Avoids further deterioration and scarring
§ Enables initiation of wound healing
§ Allows direct visual assessment of wound
bed enabling precise diagnosis of wound
severity and an informed treatment plan
bed enabling precise diagnosis of wound
severity and an informed treatment plan
Surgical eschar removal
§ Tangential excision
§ Dermabrasion
§ Hydro-jet surgery
Significant limitations
§ Traumatic
§ Challenging in delicate areas and patients
§ Non-selective
§ Donor sites sacrifice discomfort and long-term
sequelae
sequelae
§ Delayed start of debridement (diagnosis
dependent)
dependent)
Non-surgical eschar
removal
removal
§ Autolysis
§ Topical medications
§ Enzymes, chemicals and biologicals
Significant limitations
§ Limited debriding efficacy
§ Excessively prolonged debridement with risks
§ Less useful for deep and extensive burns
§ Numerous dressing changes and wound handlings
§ Biological drug containing a sterile mixture of proteolytic
enzymes
enzymes
§ Easy to use, single, non-surgical topical application at the
patient’s bedside
patient’s bedside
§ Effectively removes the burn eschar within 4 hours
without harming surrounding viable tissue
without harming surrounding viable tissue
§ Allows the physician to visually assess the wound and
reach an informed decision
reach an informed decision
§ Orphan and biologic drug status in EU and US
§ IP protection until at least 2025 in EU and 2029 in US
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Before
After
Intact skin
preserved
preserved
Non-injured
dermis
preserved
dermis
preserved
§ Six Phase 2 and Phase 3 clinical
studies completed, assessing
safety and efficacy of NexoBrid
studies completed, assessing
safety and efficacy of NexoBrid
§ Investigated in more than 550
hospitalized burn patients
hospitalized burn patients
§ Sites across 15 countries and
4 continents
4 continents
§ Investigated by ~100 leading burn
specialists and KOLs
specialists and KOLs
§ EU Phase 3 trial was completed
early, after interim analysis
showed statistically significant
results
early, after interim analysis
showed statistically significant
results
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-> Less autografting provides additional benefits including less
surgery, donor site morbidity and permanent scarring
surgery, donor site morbidity and permanent scarring
P value < 0.0001
Incidence of excision (all wounds-ITT)
P value < 0.0001
P value = 0.0055
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Outcome
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NexoBrid
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SOC
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Comments
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All wounds
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Modified Vancouver Scar Scale (per wound)
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3.12 (113)
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3.38 (78)
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Donor site scars
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Incidence (per patient)
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40% (22 / 54)
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68% (24 / 35)
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P-value = 0.01
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Area % TBSA (per patient)
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5.8% (22)
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8.3% (24)
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30% smaller scars
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Modified Vancouver Scar Scale (per wound)
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0.75 (32)
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0.97 (35)
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Long term scar treatment procedures
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27.8% (15 / 54)
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34.3% (12 / 35)
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Surgical scar reconstructive procedures (incidence
per patient) |
3.74% (2 / 54)
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8.57% (3 / 35)
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Overall favorable long-term results: comparable quality with significant reduction in quantity of scars
achieved with reduced surgical burden (excision, grafting and reconstructive procedures)
achieved with reduced surgical burden (excision, grafting and reconstructive procedures)
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*Confirmed by clinical data
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Standard of Care
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Important Elements
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NexoBrid*
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Surgical
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Non-Surgical
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Time to Start Debridement
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Rapid Debridement
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Time to Complete Debridement
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Diagnosis-Fast/Effective/Selective
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Less Traumatic/Surgeries
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Spare Viable Tissue
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Reduced Area for Grafting (Minimal Invasive Modality)
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Less Procedural Blood Loss
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Procedural Pain
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Complexity/cost effectiveness (Surgeons, facilities, general
anesthesia, multiple debridement procedures) |
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Advantage
Disadvantage
Global - marketing strategy and tools are ready to
support our local sales force and go to market
support our local sales force and go to market
EU - launch through wholly owned local subsidiary
▪ Recruited nearly all the team across EU (~25 FTE’s)
▪ Launched NexoBrid in all target countries in EU (except
FR & CZ) and in Israel
▪ Executing our market access plans across EU, on a
country-by-country basis
International - signed and negotiating distribution
agreements to expand market reach to LATAM, Asia-
Pacific and CIS
agreements to expand market reach to LATAM, Asia-
Pacific and CIS
US - enhancing marketing strategy in parallel to clinical
development
development
NO
SE
FI
ES
FR
IT
PL
DE
CZ
RO
HU
SK
AT
UK
IE
PT
EE
LV
LT
BG
GR
CH
NL
BE
IS
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Interest
Work flow
assimilation
assimilation
Reimbursement
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§ Targeting specialist call point at burn centers and hospital burn units
§ Smaller hospitals are expected to follow the trend
c. 120 Burn centers
c. 360 Large hospitals
Other hospitals
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c. 120 Burn centers
# of BC’s
§ Trained: ~ 60% of target burn centers throughout Europe
§ Treating: ~ 60% of trained centers
§ Patients treated in 2015 > 2014 total
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Sales (€)
Patients
treated
treated
Burn center (Berlin, Germany)
Sales linear trend-line
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§ Prospective
§ Randomized
§ Controlled: NexoBrid vs. Vehicle vs. Standard of care - 3:1:3
§ Masked
§ Multi-Center : ~ 30 centers in US, EU and IL
§ Follow up: 12 & 24 months
§ Sample size: 175 patients
§ Primary: Incidence of eschar removal vs. vehicle
§ Secondary: Surgical burden, earlier eschar removal and blood loss vs. SOC
§ Safety: Wound closure and cosmesis & function vs. SOC
§ Initiation: 1H/15
§ Acute (primary/secondary/safety) results: 1H/17
§ Long term results: 12 months follow up (1H/18); 24 month follow up (1H/19)
Study
Design
Design
Endpoints
Study
Timelines
Timelines
5% of diabetics or ~1.3 M people
develop DFUs annually
develop DFUs annually
Millions receive post-surgical
wound care in US annually
wound care in US annually
Affecting ~600,000 people
in the US annually
in the US annually
2.5 M pressure ulcers
treated in the US in acute
care facilities annually
treated in the US in acute
care facilities annually
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§ Market estimated to grow > 8% annually due to aging, diabetes and obesity
§ Large unmet medical need for an effective, non-surgical eschar removal agent in chronic wounds
§ Existing products are complementary
Debridement
critical 1st step
in healing
chronic wounds
critical 1st step
in healing
chronic wounds
Venous
Leg Ulcers
Leg Ulcers
Pressure
Ulcers
Ulcers
Surgical/
Traumatic
Wounds
Traumatic
Wounds
Diabetic Foot
Ulcers
Ulcers
Incidence of DFUs*
Incidence of VLUs*
~70% undergo
debridement
debridement
~55% undergo
debridement
debridement
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Over $1B market potential in DFU’s and VLU’s in the US alone
Study
Design
Design
Endpoints
Study
Timelines
Timelines
§ Prospective
§ Randomized
§ Controlled (EscharEx vs. Gel)
§ Multi-Center
§ Sample size: 72 patients
§ Indications: Hard to heal VLUs, DFUs and post surgical
§ Eschar removal
§ Wound closure
§ Initiation: 2H/14
§ Top-line results: 2H/15
§ Final results: 1H/16
Summary of on-going 2nd Phase 2 study
2013
2015
On-going
Study
Study
Completed
Studies
Studies
2nd Phase 2
2016
Planned
Studies
Studies
Phase 3
Development timeline
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Balance sheet
Statement of operations
§ Capital structure: 21.5m outstanding ordinary shares;
1.9m outstanding stock options
1.9m outstanding stock options
§ Cash position: $59.4m (as of 31/3/15); no debt
§ NOL: $70m carry-forward losses; Favorable tax rates
(“beneficiary enterprise”)
(“beneficiary enterprise”)
§ Operating loss (Q1/15): $4.5m; Adjusted EBITDA $3.7m
§ Burn rate Q1/15: Net cash used for ongoing operating
activities ~ $4.8m
activities ~ $4.8m
§ Y15 cash use is estimated at $20-22m
§ Current cash balance is sufficient to:
§ Complete our ongoing clinical programs
§ Support our EU marketing infrastructure
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($ in millions)
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3 months ended
March 31, 2015 |
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Revenues
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0.1
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Gross loss
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0.1
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Research and development, net
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1.4
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Selling, general and administrative
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3.0
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Operating loss
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4.5
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($ in millions)
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As of March 31, 2015
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Cash, cash equivalents and short
term cash deposits |
59.4
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Working capital
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59.6
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Total assets
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65.6
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Contingent royalty-based liabilities
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24.5
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Total shareholders’ equity
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37.1
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Completed IPO; $71.7M net proceeds
Establishment of a full commercial
organization in EU
organization in EU
Launched NexoBrid in all key EU target
markets (except FR & CZ) and in Israel
markets (except FR & CZ) and in Israel
Signed distribution agreements in
LATAM, CIS, Asia-Pacific markets
LATAM, CIS, Asia-Pacific markets
Started EscharEx Phase II study
Started NexoBrid Pediatric
Phase III study
Phase III study
2014
Start of NexoBrid US
Phase III study
Phase III study
New distribution channels in
additional international markets
additional international markets
Obtain marketing authorization in
additional markets
additional markets
Expand EU launch
Top-line data from EscharEx
Phase II study
Phase II study
2015
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New paradigm in eschar removal
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§ Easy to use, non-surgical, single application with significant advantages over SOC
§ Approved and launched in Europe
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Attractive target markets
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§ Hospitalized burn patients - orphan indication, focused target audience of burn
specialists § Chronic wounds - significantly large and growing market
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Extensive clinical experience
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§ More than 550 patients in six Phase 2 and Phase 3 clinical studies across 15 countries
§ Support from more than 100 burn specialists and key opinion leaders (KOLs)
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Lower development risk
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§ Wealth of existing and relevant development data to date
§ Promising clinical and ex-vivo data
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Fully integrated platform
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§ In-house manufacturing, R&D and commercial operations
§ Control over all critical aspects of the business to drive growth and profitability
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Significant barriers to entry
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§ Strong IP position and know-how
§ Orphan drug status and other regulatory exclusivities
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Experienced management team
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§ Significant pharmaceutical, medical, marketing and product launch experience
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www.mediwound.com