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REVIEW AND PROSPECTS
A. Operating Results
The information contained in this section should
be read in conjunction with our consolidated financial statements for the year ended December 31, 2025 and related notes, and the information
contained elsewhere in this annual report. Our financial statements have been prepared in accordance with IFRS, as issued by the IASB.
Company Overview
We are a biopharmaceutical company that develops, manufactures,
and commercializes novel, cost effective, biotherapeutic, non-surgical solutions for tissue repair and regeneration. Our strategy leverages
our breakthrough enzymatic technology platform into diversified portfolio of biotherapeutics across multiple indications to pioneer solutions
for unmet medical needs. Our current portfolio is focused on next-generation protein-based therapies for burn care, wound care and tissue
repair.
Our first innovative biopharmaceutical product, NexoBrid is a topically
administered, biological orphan drug for the enzymatic removal of eschar in patients with deep partial- and full-thickness thermal burns.
It selectively removes non-viable tissue while preserving viable tissue and is approved for use in adults and pediatric patients in 45
countries, including the United States, European Union, and Japan.
We commercialize NexoBrid globally through multiple sales channels.
We sell NexoBrid to burn centers in the EU, UK and Israel, primarily through our direct sales force, focusing on key burn centers and
KOLs. In the United States, we entered into exclusive license and supply agreements with Vericel Corporation (Nasdaq: VCEL) to commercialize
NexoBrid in North America. We have established local distribution channels in multiple international markets, focusing on Asia Pacific,
EMEA, CEE and LATAM, which local distributors are also responsible for obtaining local marketing authorization within the relevant territories.
EscharEx, our next-generation enzymatic therapy under development,
is a bromelain-based, bioactive enzymatic therapy in advanced clinical development for the debridement of chronic and hard-to-heal wounds.
Designed for topical, once-daily application, EscharEx has demonstrated a favorable safety profile and effective wound bed preparation
in multiple Phase II trials. The therapy has shown the ability to remove non-viable tissue, promote granulation tissue, and reduce bioburden
and biofilm. In February 2025 we initiated the VALUE, a global, pivotal Phase III trial evaluating EscharEx for the treatment of
venous leg ulcers (VLUs). The VALUE study is a global, multicenter, prospective, randomized, double-blind, placebo-controlled trial with
an adaptive design, that will be conducted across 40 sites in the U.S. and Europe, with the majority of sites already active. Its primary
objective is to evaluate the efficacy and safety of EscharEx in achieving effective debridement and preparing the wound bed for healing
in VLUs. The study will enroll 216 patients, randomized 1:1 to receive either EscharEx or placebo. The study co-primary endpoints are
the incidence of complete debridement and the facilitation of wound closure. Secondary endpoints include the incidence of complete healthy
granulation tissue, time to complete debridement, time to wound bed prepared and incidence of complete wound closure. Safety and tolerability
of EscharEx will be assessed throughout the trial. An interim sample size assessment will occur after 65% of patients complete treatments,
enabling adaptive adjustments as needed. The interim assessment and enrollment completion are expected by year-end 2026.
To support the trial, we have established strategic research collaborations
with Essity, Solventum, Mölnlycke, and MIMEDX. These industry leaders will provide advanced products to ensure consistent wound management
across all study sites and optimize patient outcomes.
We manufacture NexoBrid and our product candidates in our cGMP
certified sterile manufacturing facility at our headquarters in Yavne, Israel.
As of December 31, 2025, we had cash and cash equivalents and short
term and restricted bank deposits of $53.6 million. Our revenues were $17.0 million and $20.2 million in 2025 and 2024, respectively.
Our net operating loss was $25.3 million and $19.4 million in 2025 and 2024, respectively. We had an accumulated deficit of $228.9 million
as of December 31, 2025. We expect to incur significant expenses and operating losses in the coming years, as research and development
activities are central to our operations, which will offset by cash inflows from NexoBrid.
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We expect to continue to invest in our research and development
efforts, including in respect of our EscharEx planned clinical trials, as well as the clinical development and trials of our other pipeline
product candidates. In addition, we expect to continue to advance NexoBrid as a standard of care, and expand its commercial reach in international
markets, including for potential use as a medical countermeasure during mass casualty events.
Key Components of Statements of Operations
Revenues
Sources of revenues. We
derive revenues from sales of NexoBrid to burn centers and hospitals burn units in USA, Europe, Japan and Israel as well as to local distributors
in other countries in accordance with distribution agreements we have in place, which also include revenues from licenses.
We generate revenues from development services provided to BARDA,
and to DoW/MTEC.
Our ability to generate additional, more significant revenues will
depend on the successful commercialization of NexoBrid and our ability to scale up the production.
Cost of Revenues
Our total cost of revenues includes expenses for the manufacturing
of NexoBrid, including: the cost of raw materials; employee-related expenses, including salaries, equity based-compensation and other
benefits and related expenses, lease payments, utility payments, depreciation, changes in inventory of finished products, royalties and
other manufacturing expenses including adjustment for inventory impairment. These expenses are partially reduced by (i) an allocation
of manufacturing costs associated with research and development and Scale-Up activities to research and development expenses, and (ii)
the capitalization of certain manufacturing costs as property and equipment in connection with the establishment and expansion of our
Scale-Up facility.
Cost of revenues includes costs associated with the research and
development services provided to BARDA and MTEC, including salaries and related expenses, clinical trials, sub-contractors and external
advisors.
Operating Expenses
Research and Development Expenses
Research and development activities are central to our business
model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages
of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect research and development
costs to increase significantly for the foreseeable future as EscharEx progresses in its clinical program in the U.S. and our other pipeline
product candidates’ progress in clinical trials. However, we do not believe that it is possible at this time to accurately project
total program-specific expenses to reach commercialization. There are numerous factors associated with the successful development of any
of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with
accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will
affect our clinical development programs and plans. Our actual spending could differ as our plans change and we invest in other drugs
or potentially reduce our anticipated funding on research for existing products. Research and development expenses consist primarily of
compensation for employees engaged in research and development activities, including salaries, equity-based compensation, benefits and
related expenses, clinical trials, contract research organization sub-contractors, development materials, external advisors and the allotted
cost of our manufacturing facility for research and development purposes.
Selling and Marketing Expenses
Selling and marketing expenses consist primarily of compensation
expenses for personnel engaged in sales and marketing, including salaries, equity based-compensation and benefits and related expenses,
as well as promotion, marketing, market access, medical, and sales and distribution activities. These expenses are primarily comprised
of costs related to our subsidiary in Germany, which is focused on marketing NexoBrid in EU, and costs related to maintain marketing authorization.
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General and Administrative Expenses
General and administrative expenses consist principally of compensation
for employees in executive and administrative functions, including salaries, equity-based compensation, benefits and other related expenses,
professional consulting services, including legal and audit fees, as well as costs of office and overhead.
Financial Income/Financial Expense
Financial income includes interest income, revaluation of financial
instruments and exchange rate differences. Financial expense consists primarily of revaluation of financial instruments, revaluation of
lease liabilities and exchange rate differences. The market interest due on government grants received from the IIA is also considered
a financial expense, and is recognized beginning on the date we receive the grant until the date on which the grant is expected to be
repaid as part of the revaluation to fair value of liabilities in respect of government grants.
Taxes on Income
The standard corporate tax rate in Israel is 23%.
We do not generate taxable income in Israel, as we have historically
incurred operating losses resulting in carry forward tax losses and other temporarily differences from R&D expenses totalling approximately
$213.0 million as of December 31, 2025. We anticipate that we will be able to carry forward these tax losses indefinitely to future tax
years. Accordingly, we do not expect to pay taxes in Israel until we have taxable income after the full utilization of our carry forward
tax losses.
Under the Law for the Encouragement of Capital Investments, 5719-1959
(the “Investment Law”), we have been granted “Beneficiary Enterprise” status, which provides certain benefits,
including tax exemptions and reduced corporate tax rates. Income not eligible for Beneficiary Enterprise benefits is taxed at the regular
corporate tax rate. The benefit entitlement period starts from the first year that the Beneficiary Enterprise first earns taxable income,
and is limited to 12 years from the year in which the company requested to have tax benefits apply.
Comparison of Period to Period Results of Operations
We are providing within this section a supplemental discussion
that compares our historical statement of operations data in accordance with IFRS, as issued by the IASB. The below table and the below
discussion provide data for each of the years ended December 31, 2025 and 2024. The below discussion of our results of operations omits
a comparison of our results for the years ended December 31, 2024 and 2023. In order to view that discussion, please see “ITEM 5.
Operating and Financial Review and Prospects-A. Operating Results- Comparison of Period to
Period Results of Operations- Year Ended December 31, 2024 Compared to
Year Ended December 31, 2023” in our Annual Report on Form 20-F for the year ended December 31, 2024, which we filed with the SEC
on March 19, 2025.
Years Ended December 31,
2025 2024
(in thousands)
Condensed statements of operations data:
Revenues $ 16,959 $ 20,222
Cost of revenues 13,705 17,588
Gross profit 3,254 2,634
Operating expenses:
Research and development 14,320 8,878
Selling and marketing 5,765 4,936
General and administrative 8,448 8,202
Other (income) expenses (13 ) 18
Operating loss (25,266 ) (19,400 )
Financial income (expenses), net 1,556 (10,763 )
Loss before taxes on income (23,710 ) (30,163 )
Taxes on income (169 ) (61 )
Net loss $ (23,879 ) $ (30,224 )
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Year Ended December 31, 2025
Compared to Year Ended December 31, 2024
Revenues
Years Ended December 31,
2025 2024
(in thousands)
Revenues from sale of products $ 5,769 $ 6,832
Revenues from development services 10,800 13,135
Revenues from license agreements and royalties 390 255
16,959 20,222
We generated total revenues of approximately $17.0 million for
the year ended December 31, 2025 compared to approximately $20.2 million for the year ended December 31, 2024. The change is primarily
attributable to the U.S. government shutdown, which resulted in delays in budget approvals and the initiation of new contractual agreements
as well as lower product sales by Vericel.
Revenues from sale of products
Revenues from sales of products in 2025 were $5.8 million, a 15%
decrease compared to $6.8 million in 2024 mainly driven by decreased revenues from Vericel.
Revenues from development services
Revenues from development services in 2025 were $10.8 million,
a 18% decrease compared to $13.1 million in 2024. The decrease mainly is driven by the U.S. government shutdown, which resulted in delays
in budget approvals and the initiation of new contractual agreements.
Revenues from license agreements and royalties
In 2025, revenues from license agreements and royalties were $0.4
million compared to $0.3 million in 2024, the increase mainly driven by increased royalties from Vericel.
Our revenues, as reported in our consolidated financial statements,
are based on the location of the customers, as shown in the below table:
Year ended December 31
2025 2024
USA (see also note 18a, 18b, 18c) 11,784 15,463
Germany 817 824
Italy 1,002 817
Spain 1,291 840
Rest of the world 2,065 2,278
16,959 20,222
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DoW/MTEC contributed 33% and 34% of the Company’s total revenues
in 2025 and 2024 respectively. BARDA contributed 30% and 31% of the Company’s total revenues in 2025 and 2024 respectively. Vericel
contributed 6% and 12% of the Company’s total revenues in 2025 and 2024 respectively.
Costs and Expenses
Cost of revenues
Years Ended December 31,
2025 2024
(in thousands)
Cost of revenues from sales of products $ 4,727 $ 6,440
Cost of revenues from development services 8,946 11,128
Cost of revenues from license agreements and royalties 32 20
13,705 17,588
Cost of revenues as a percentage of total revenues decreased from
87% for 2024 to 81% for 2025.
Cost of revenues from sales of products as a percentage of revenues
from sales of products decreased to approximately 82% for the year ended December 31, 2025, from approximately 94% in the year ended
December 31, 2024. The decrease is mainly due to a favourable change in revenue mix. Cost of revenues from development services as a percentage
of revenues from development services was approximately 83% in the year ended December 31, 2025, compared to approximately 85% in the
year ended December 31, 2024. The change is primarily driven by activity linked to operating expenses with higher margin.
Cost of revenues from license agreements and royalties as a percentage
of revenues from license agreements was 8% in the year ended December 31, 2025 compared to approximately 8% in the year ended December
31,2024.
Research and development expenses,
Research and development expenses increased by 61% from approximately
$8.9 million in the year ended December 31, 2024 to approximately $14.3 million in the year ended December 31, 2025, mainly due to costs
associated with the EscharEx VALUE Phase III trial.
Selling and marketing expenses
Selling and marketing expenses increased by 17% in 2025 compared
to 2024, from approximately $4.9 million in the year ended December 31, 2024 to approximately $5.8 million in the year ended December
31, 2025. The increase is mainly due to higher Marketing Authorization Holder expenses.
General and administrative expenses
General and administrative expenses increased by 3% in 2025 compared
to 2024 from approximately $8.2 million in the year ended December 31, 2024 to approximately $8.4 million in the year ended December 31,
2025. The increase primarily reflects foreign exchange rate fluctuations and additional headcount to support the Company’s growth.
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Financial income, net Years Ended December 31,
2025 2024
(in thousands)
Financial income $ 4,017 $ 2,048
Financial expenses (2,461 ) (12,811 )
1,556 (10,763 )
Financial income
Financial income increased from approximately $2.0 million in the
year ended December 31, 2024 to approximately $4.0 million in the year ended December 31, 2025. The increase was primarily driven by $2.2
million financial income from the revaluation of warrants.
Financial expense
Financial expenses decreased from approximately $12.8 million for
the year ended December 31, 2024 to approximately $2.5 million for the year ended December 31, 2025. The decrease was primarily attributable
to the recognition of financial income from the revaluation of warrants in 2025, compared to financial expenses recorded from the revaluation
of warrants in 2024.
B. Liquidity and Capital Resources
Our primary uses of cash are to fund working capital requirements,
manufacturing costs, research and development activities related to EscharEx and other products candidates, capital expenditure requirements,
as well as sales and marketing activities associated with the commercialization of NexoBrid in Europe.
Primary Cash Sources
In recent years, we have funded our operations from a combination
of sources, including:
(i) revenues from sales of NexoBrid to burn centers and hospitals burn units in USA, Europe, Japan and Israel as well as to local distributors in other countries in accordance with distribution agreements we have in place, which also include revenues from licenses.
(ii) revenues from development services provided to BARDA, and to DoW/MTEC;
(iii) government grants
(iv) public and private offerings of our securities; and
(v) exercise of series A Warrants
Recent Public and Private Securities Offerings
On February 3, 2023, we entered into a securities purchase agreement
(the “2023 Securities Purchase Agreement”) with the purchasers listed on the signature pages thereto (the “2023 Purchasers”),
in connection with the offer and sale of 1,964,286 ordinary shares (the “2023 Offering”). The purchase price per ordinary
share was $14.00. The 2023 Offering closed on February 7, 2023. The gross proceeds from the 2023 Offering were approximately $27.5 million.
On July 15, 2024, we entered into a share purchase agreement (the
“2024 Share Purchase Agreement”) with the purchasers listed on the signature pages thereto (the “2024 Purchasers”),
for the offer and sale of 1,453,488 ordinary shares at a purchase price per share of $17.20 (the “2024 Offering”). The gross
proceeds from the 2024 Offering were $25 million.
Along with our entry into the 2024 Share Purchase Agreement, we
entered into a registration rights agreement with the 2024 Purchasers (the “2024 Registration Rights Agreement”), providing
the 2024 Purchasers customary registration rights with respect to the ordinary shares to be issued to them pursuant to the 2024 Offering
and any additional Registrable Securities, as defined therein.
On September 9, 2024, the SEC declared effective our shelf registration
statement on Form F-3, which registered the resale of 1,453,488 shares.
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On March 27, 2025, the SEC declared effective our shelf registration
statement on Form F-3, and registered offerings of up to $125,000,000 in various securities and the resale of up to 1,266,141 ordinary
shares.
On September 29, 2025, we entered into a securities purchase agreement
(the “2025 Securities Purchase Agreement”) with certain purchasers (the “2025 Purchasers”), in connection with
the offer and sale of 1,734,105 ordinary shares (the “2025 Offering”). The purchase price per ordinary share was $17.30. The
2025 Offering closed on September 30, 2025. The Gross proceeds from the 2025 Offering were approximately $30.0 million.
H.C. Wainwright & Co., LLC (“Wainwright”) acted
as the exclusive placement agent for the 2025 Offering. Upon closing of the 2025 Offering, we paid Wainwright a cash transaction fee equal
to 7.0% of the aggregate gross proceeds from the 2025 Offering (or 1.75% to 5% in the case of certain designated investors). We also agreed
to pay Wainwright for its role as exclusive placement agent in the 2025 Offering a non-accountable expense allowance of $85,000.00 and
clearing fees of $15,950.00.
Recent Government Grant
In July 2024, we were awarded a €2.5 million grant from the
European Innovation Council (EIC) Accelerator program to support the clinical and regulatory advancement of EscharEx for the treatment
of diabetic foot ulcers (DFUs). Following a successful evaluation process, we entered into discussions with respect to a potential additional
€13.75 million equity investment component under the EIC Accelerator program; however, these discussions did not result in an equity
investment. In December 2024, we received the first payment of Euro 1.1 million from the grant component.
In 2025, we received an additional $3.6 million in funding from
the U.S. DoW to advance development of a room-temperature stable formulation of NexoBrid. The supplemental funding will support expanded
CMC activities, enhancement of in-house manufacturing capabilities and initial preparations for a clinical trial.
Overall Outlook
We believe that our existing cash and cash equivalents, short-term
and restricted bank deposits of $53.6 million as of December 31, 2025, will be sufficient to fund its operations and capital expenditure
for at least twelve months from the date of issuance of our consolidated financial statements included in this annual report.
Our future capital requirements will depend on many factors, including
our revenue growth, timing of milestone payments, the timing and extent of our spending on research and development efforts, and international
expansion. We may also seek to invest in or acquire complementary businesses or technologies. To the extent that existing cash and cash
from operations are insufficient to fund our future activities, we may need to raise additional funding through debt and equity financing.
Additional funds may not be available on favourable terms or at all.
The accompanying consolidated financial statements have been prepared
on a basis which assumes that the Company will continue as a going concern. From inception to December 31, 2025, the Company has incurred
cash outflows from operations, losses from operations, and has an accumulated deficit of $228.9 million.
Cash Flows
The following table summarizes our consolidated statement of cash
flows for the periods presented. The below discussion beneath the table omits a description of our cash flows for the year ended December
31, 2024. In order to view that discussion, please see “ITEM 5. Operating and Financial Review and Prospects Liquidity and Capital
Resources” in our Annual Report on Form 20-F for the year ended December 31, 2024, which we filed with the SEC on March 19, 2025:
Year Ended December 31,
2025 2024
Net cash provided by (used in):
Operating activities $ (16,121 ) $ (13,624 )
Investing activities (17,950 ) (8,397 )
Financing activities 29,620 19,394
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Net cash used in operating activities
Net cash used in all periods resulted primarily from our net loss
adjusted for non-cash items and changes in components of working capital. Adjustments of non-cash items include depreciation and amortization,
share-based compensation, revaluation of warrants and changes in assets and liabilities items.
Net cash used in operating activities increased to approximately
$16.1 million in the year ended December 31, 2025 compared to net cash used in operating activities of approximately $13.6 million in
the year ended December 31, 2024, primarily as a result of adjustment of non-cash items from revaluation of warrants, offset by lower
operational net loss.
Net cash used in investing activities
Net cash used in investing activities primarily derives from investment
in short term banks deposits and from purchases of property and equipment mainly related to scaling up our production facility, offset
by interest received from short term bank deposit. Net cash used in investing activities was $18.0 million in the year ended December
31, 2025, compared to $8.4 million provided during the year ended December 31, 2024, primarily result from investment in short- term bank
deposits.
Net cash provided by financing activities
Net cash provided by financing activities consists of proceeds
from the issuance of shares and from exercise of warrants and share options, offset primarily by the repayment of lease liability and
liabilities in respect of Teva. For the year ended December 31, 2025, net cash provided by financing activities was $29.6 million, compared
to $19.4 million for the year ended December 31, 2024. The increase was primarily attributable to higher proceeds from the issuance of
shares and the exercise of warrants and share options, as well as lower repayments of liability in respect of Teva in 2024.
Israeli Corporate-Level Tax Considerations and Government Programs
The following is a brief summary of the material Israeli tax laws
applicable to us, and certain Israeli Government programs that benefit us and therefore impact our results of operations and financial
condition. To the extent that the discussion is based on new tax legislation that has not yet been subject to judicial or administrative
interpretation, we cannot assure you that the appropriate tax authorities or the courts will accept the views expressed in this discussion.
The discussion below is subject to change, including due to amendments under Israeli law or changes to the applicable judicial or administrative
interpretations of Israeli law, which change could affect the tax consequences described below.
General Corporate Tax Structure in Israel
Generally, Israeli companies are subject to a corporate tax on
their taxable income. Effective January 1, 2018 and thereafter, the corporate tax rate is 23%. However, the effective tax rate payable
by a company that derives income from an Approved Enterprise, a Beneficiary Enterprise, a Preferred Enterprise or Technology Enterprise
(as discussed below) may be considerably less. Capital gains derived by an Israeli company are generally subject to the prevailing regular
corporate tax rate.
Law for the Encouragement of Industry (Taxes),
5729-1969
The Law for the Encouragement of Industry (Taxes), 5729-1969 (the
“Industry Encouragement Law”), provides several tax benefits for “Industrial Companies.”
The Industry Encouragement Law defines an “Industrial Company”
as an Israeli resident-company which was incorporated in Israel, of which 90% or more of its income in any tax year, other than income
from certain government loans, is derived from an “Industrial Enterprise” owned by it and located in Israel or in the “Area”,
in accordance with the definition under section 3A of the Israeli Income Tax Ordinance (New Version) 1961 (the “Ordinance”).
An “Industrial Enterprise” is defined as an enterprise whose principal activity in a given tax year is industrial production.
The following tax benefits, among others, are available to Industrial
Companies:
• amortization of the cost of purchased a patent, rights to use a patent, and know-how, which are used for the development or advancement of the Industrial Enterprise, over an eight-year period, commencing on the year in which such rights were first exercised;
• under limited conditions, an election to file consolidated tax returns with related Israeli Industrial Companies controlled by it; and
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• expenses related to a public offering are deductible in equal amounts over a three year period commencing on the year of the offering.
Eligibility for benefits under the Industry Encouragement Law is
not contingent upon approval of any governmental authority.
We believe that we currently qualify as an Industrial Company within
the meaning of the Industry Encouragement Law. However, there can be no assurance that we will continue to qualify as an Industrial Company
or that the benefits described above will be available in the future.
Law for the Encouragement of Capital Investments,
5719-1959
The Investment Law provides certain incentives for capital investments
in production facilities (or other eligible assets).
The Investment Law was significantly amended several times during
recent years, with the three most significant changes effective as of April 1, 2005 (the “2005 Amendment”), as of January
1, 2011 (the “2011 Amendment”), and as of January 1, 2017 (the “2017 Amendment”). Pursuant to the 2005 Amendment,
tax benefits granted in accordance with the provisions of the Investment Law prior to its revision by the 2005 Amendment remain in force
but any benefits granted subsequently are subject to the provisions of the amended Investment Law. Similarly, the 2011 Amendment introduced
new benefits to replace those granted in accordance with the provisions of the Investment Law in effect prior to the 2011 Amendment. However,
companies entitled to benefits under the Investment Law as in effect prior to January 1, 2011 were entitled to choose to continue to enjoy
such benefits, provided that certain conditions are met, or elect instead, irrevocably, to forego such benefits and have the benefits
of the 2011 Amendment apply. The 2017 Amendment introduces new benefits for Technological Enterprises, alongside the existing tax benefits.
Prior to 2011, we did not utilize any of the benefits for which we were eligible under the Investment Law.
The following is a summary of the Investment Law subsequent to
its amendments as well as the relevant changes contained in the new legislation.
Tax Benefits Subsequent to the 2005 Amendment
The 2005 Amendment applies to new investment programs and investment
programs commencing after 2004, but does not apply to investment programs approved prior to April 1, 2005 (“Approved Enterprise”).
The 2005 Amendment provides that terms and benefits included in any certificate of approval that was granted before the 2005 Amendment
became effective (April 1, 2005) will remain subject to the provisions of the Investment Law as in effect on the date of such approval.
Pursuant to the 2005 Amendment, the Israeli Authority for Investments and Development of the Israeli Ministry of Economy (the “Investment
Center”) will continue to grant Approved Enterprise status to qualifying investments. The 2005 Amendment, however, limits the scope
of enterprises that may be approved by the Investment Center by setting criteria for the approval of a facility as an Approved Enterprise.
The 2005 Amendment provides that Approved Enterprise status will
only be necessary for receiving cash grants. As a result, it is no longer necessary for a company to obtain the advance approval of the
Investment Center in order to receive the tax benefits previously available under the alternative benefits track. Rather, a company may
claim the tax benefits offered by the Investment Law directly in its tax returns, provided that its facilities meet the criteria for tax
benefits set forth in the 2005 Amendment. Companies or programs under the new provisions receiving these tax benefits are referred to
as Beneficiary Enterprises. Companies that have a Beneficiary Enterprise, are entitled to approach the Israel Tax Authority for a pre-ruling
regarding their eligibility for tax benefits under the Investment Law, as amended. Tax benefits are available under the 2005 Amendment
to production facilities (or other eligible facilities), which are generally required to derive more than 25% of their business income
from export to specific markets with a population of at least 14 million in 2012 (such export criteria will further increase in the future
by 1.4% per annum). In order to receive the tax benefits, the 2005 Amendment states that a company must make an investment which meets
certain conditions, including exceeding a minimum investment amount specified in the Investment Law. Such investment allows a company
to receive “Beneficiary Enterprise” status, and may be made over a period of no more than three years ending in the year in
which the company chose to have the tax benefits apply to its Beneficiary Enterprise. Where the company requests to apply the tax benefits
to an expansion of existing facilities, only the expansion will be considered to be a Beneficiary Enterprise and the company’s effective
tax rate will be the weighted average of the applicable rates. In this case, the minimum investment required in order to qualify as a
Beneficiary Enterprise is required to exceed a certain percentage of the value of the company’s production assets before the expansion.
The extent of the tax benefits available under the 2005 Amendment
to qualifying income of a Beneficiary Enterprise depends on, among other things, the geographic location in Israel of the Beneficiary
Enterprise. The location will also determine the period for which tax benefits are available. Such tax benefits include an exemption from
corporate tax on undistributed income for a period of between two to ten years, depending on the geographic location of the Beneficiary
Enterprise in Israel, and a reduced corporate tax rate of between 10% to 25% for the remainder of the benefits period, depending on the
level of foreign investment in the company in each year. A company qualifying for tax benefits under the 2005 Amendment which pays a dividend
out of income attributed to its Beneficiary Enterprise during the tax exemption period will be subject to corporate tax in respect of
the amount of the dividend distributed (grossed-up to reflect the pre-tax income that it would have had to earn in order to distribute
the dividend) at the corporate tax rate that would have otherwise been applicable. Dividends paid to Israeli shareholders out of income
attributed to a Beneficiary Enterprise (or out of dividends received from a company whose income is attributed to a Beneficiary Enterprise)
are generally subject to withholding tax at source at the rate of 15% (in the case of non-Israeli shareholders - subject to the receipt
in advance of a valid certificate from the ITA allowing for a reduced tax rate, 15% or such lower rate as may be provided in an applicable
tax treaty, applicable to dividends and distributions out of income attributed to a Beneficiary Enterprise). The reduced rate of 15% is
limited to dividends and distributions out of income attributed to a Beneficiary Enterprise during the benefits period and actually paid
at any time up to 12 years thereafter, except with respect to a qualified Foreign Investment Company (as such term is defined in the Investment
Law), in which case the 12-year limit does not apply.
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The benefits available to a Beneficiary Enterprise are subject
to the fulfillment of conditions stipulated in the Investment Law and its regulations. If a company does not meet these conditions, it
would be required to refund the amount of tax benefits, as adjusted by the Israeli consumer price index, and interest, or other monetary
penalties.
We currently have Beneficiary Enterprise programs under the Investment
Law, which we believe will entitle us to certain tax benefits. The majority of any taxable income from our Beneficiary Enterprise programs
(once generated) would be tax exempt for a period of ten years commencing in the year in which we will first earn taxable income relating
to such enterprises, subject to the 12-year limitation from the year the company chose to have its tax benefits apply.
Tax Benefits Under the 2011 Amendment
The 2011 Amendment canceled the availability of the tax benefits
granted under the Investment Law prior to 2011 and, instead, introduced new tax benefits for income generated by a “Preferred Company”
through its “Preferred Enterprise” (as such terms are defined in the Investment Law) as of January 1, 2011. The definition
of a Preferred Company includes a company incorporated in Israel that is not fully owned by a governmental entity, and that has, among
other things, Preferred Enterprise status and is controlled and managed from Israel. The tax benefits under the 2011 Amendment for a Preferred
Company meeting the criteria of the law include, among others, a reduced corporate tax rate of 15% for preferred income attributed to
a Preferred Enterprise in 2011 and 2012, unless the Preferred Enterprise was located in a specified development zone, in which case the
rate was 10%. Under the 2011 Amendment, such corporate tax rate was reduced in 2013 from 15% and 10%, respectively, to 12.5% and 7%, respectively,
and then increased to 16% and 9%, respectively, in 2014 and thereafter until 2016. Pursuant to the 2017 Amendment, in 2017 and thereafter,
the corporate tax rate for Preferred Enterprise which is located in a specified development zone was decreased to 7.5%, while the reduced
corporate tax rate for other development zones remains 16%. Income attributed to a Preferred Company from a “Special Preferred Enterprise”
(as such term is defined in the Investment Law) would be entitled, during a benefits period of 10 years, to reduced tax rates of 8%, or
5% if the Special Preferred Enterprise is located in a certain development zone. As of January 1, 2017, the definition of “Special
Preferred Enterprise” includes less stringent conditions. Dividends paid to Israeli shareholders out of preferred income attributed
to a Preferred Enterprise or to a Special Preferred Enterprise are generally subject to withholding tax at source at the rate of 20% (in
the case of non-Israeli shareholders - subject to the receipt in advance of a valid certificate from the ITA allowing for a reduced tax
rate, 20%, or such lower rate as may be provided in an applicable tax treaty(. However, if such dividends are paid to an Israeli company,
no tax is required to be withheld (although, if such dividends are subsequently distributed to individuals or a non-Israeli company, the
aforesaid will apply).
The 2011 Amendment also provided transitional provisions to address
companies already enjoying existing tax benefits under the Investment Law. These transitional provisions provide, among other things,
that: unless an irrevocable request is made to apply the provisions of the Investment Law as amended in 2011 with respect to income to
be derived as of January 1, 2011, a Beneficiary Enterprise can elect to continue to benefit from the benefits provided to it before the
2011 Amendment came into effect, provided that certain conditions are met.
We have examined the possible effect, if any, of these provisions
of the 2011 Amendment on our financial statements and have decided, at this time, not to opt to apply the new benefits under the 2011
Amendment. There can be no assurance that we will comply with the conditions required to remain eligible for benefits under the Investment
Law in the future or that we will be entitled to any additional benefits thereunder.
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New Tax benefits under the 2017 Amendment that
became effective on January 1, 2017.
The 2017 Amendment was enacted as part of the Economic Efficiency
Law that was published on December 29, 2016, and is effective as of January 1, 2017. The 2017 Amendment provides new tax benefits for
two types of “Technology Enterprises,” as described below, and is in addition to the other existing tax beneficial programs
under the Investment Law.
The 2017 Amendment provides that a technology company satisfying
certain conditions will qualify as a “Preferred Technology Enterprise” and will thereby enjoy a reduced corporate tax rate
of 12% on income that qualifies as “Preferred Technology Income,” as defined in the Investment Law. The tax rate is further
reduced to 7.5% for a Preferred Technology Enterprise located in development zone A. In addition, a Preferred Technology Company will
enjoy a reduced corporate tax rate of 12% on capital gain derived from the sale of certain “Benefitted Intangible Assets”
(as defined in the Investment Law) to a related foreign company if the Benefitted Intangible Assets were acquired from a foreign company
on or after January 1, 2017 for at least NIS 200 million, and the sale receives prior approval from the Israeli Innovation Authority (the
“IIA”).
The 2017 Amendment further provides that a technology company satisfying
certain conditions will qualify as a “Special Preferred Technology Enterprise” and will thereby enjoy a reduced corporate
tax rate of 6% on “Preferred Technology Income” regardless of the company’s geographic location within Israel. In addition,
a Special Preferred Technology Enterprise will enjoy a reduced corporate tax rate of 6% on capital gain derived from the sale of certain
“Benefitted Intangible Assets” to a related foreign company if the Benefitted Intangible Assets were either developed by Special
Preferred Technology Enterprise or acquired from a foreign company on or after January 1, 2017, and the sale received prior approval from
IIA. A Special Preferred Technology Enterprise that acquires Benefitted Intangible Assets from a foreign company for more than NIS 500
million will be eligible for these benefits for at least ten years, subject to certain approvals as specified in the Investment Law. Dividends
distributed by a Preferred Technology Enterprise or a Special Preferred Technology Enterprise, to Israeli shareholders paid out of Preferred
Technology Income, are generally subject to withholding tax at source at the rate of 20% (in the case of non-Israeli shareholders - subject
to the receipt in advance of a valid certificate from the ITA allowing for a reduced tax rate, 20%, or such lower rate as may be provided
in an applicable tax treaty. However, if such dividends are paid to an Israeli company, no tax is required to be withheld (although, if
such dividends are subsequently distributed to individuals or a non-Israeli company, the aforesaid will apply). If such dividends are
distributed to a foreign company that holds solely or together with other foreign companies 90% or more in the Israeli company and other
conditions are met, the withholding tax rate will be 4% (or a lower under the tax treaty, if applicable, subject to the receipt in advance
of a valid certificate from the Israeli Tax Authority allowing for a reduced tax rate).
C. Research and Development, Patents and Licenses, etc.
Our research and development strategy is centered on developing
our patented proteolytic enzyme technology, which underlies NexoBrid and EscharEx, into additional products for high value indications.
Our research and development team is located at our facilities in Yavne and Gan-Rave, Israel, and consists of 35 employees as of December
31, 2025 and is supported by highly experienced consultants in various research and development disciplines.
We have received government grants (which are subject to repayment
in manner of royalties from future sales) as part of the NexoBrid and EscharEx research and development programs approved by the IIA.
The total gross amount of grants actually received by us from the IIA, including accrued interest and net of royalties actually paid,
totaled approximately $14.1 million as of December 31, 2025 and the amortized cost (using the interest method) of the liability totaled
approximately $8.5 million and $8.3 million as of December 31, 2025 and 2024, respectively. Because the repayment of IIA grants is in
the form of future royalties, the balance of the commitments to the IIA is presented as an amortized liability on our balance sheet. As
of December 31, 2025, we had accrued and paid royalties to the IIA totaling $2.5 million.
We received funds from BARDA in accordance with the terms of our
BARDA contracts. As of December 31, 2025 the Company has recognized a cumulative total of $99.8 million in revenues from development services
from BARDA for its participation in NexoBrid’s research and development programs.
We received funds from DoW and MTEC in accordance with the terms
of our DoW and MTEC contracts. As of December 31, 2025 the Company has recognized a cumulative total of $15.0 million in revenues from
development services from DoW and MTEC for its participation in the program to develop NexoBrid as a non-surgical solution for field-care
burn treatment for the U.S. Army. For a description of our research and development policies for the last three years, see “ITEM
4.B. Business Overview-Research and Development.”
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D. Trend Information
We continue to closely monitor macro-economic conditions, including
the headwinds caused by supply chain problems, inflation, increased interest rates and other trends that have been adversely impacting
economic activity on a global scale. We have been assessing, on an ongoing basis, the implications of those global conditions for our
operations, supply chain, liquidity, cash flow and product orders, and will act in an effort to mitigate adverse consequences as needed.
To the extent inflation increases our costs and expenses, we could consider price increases to offset those cost pressures.
Specific developments that may potentially impact our operating
performance in an adverse manner include:
• potential reluctancy of central banks in Europe and the U.S. to reduce interest rates for fear of an uptick in inflation, which lack of action would leave interest rates at their current relatively high levels and thereby maintain current unfavorable credit/financing conditions for our customers who purchase our products;
• potential contraction of economic activities and recessionary conditions that could arise as a result of the maintenance of relatively high interest rates and a decrease in consumer demand;
• the continued depreciated value of the Euro relative to the U.S. dollar, which may have an adverse impact on the U.S.- denominated value of our European-derived revenues for purposes of our financial statements; and
• the increase and potential future increase in tariffs imposed by the U.S. government on foreign countries, or by foreign countries on the U.S., which could broadly adversely impact the country-specific or regional economies into which our products are sold, thereby decreasing our customers’ demand for our products and resulting in a decrease in our revenues.
We cannot provide any assurances as to the extent of our resilience
to the adverse impact of these specific developments in future periods.
Other than the foregoing and as disclosed elsewhere in this annual
report, we are not aware of any trends, uncertainties, demands, commitments or events for the period from January 1, 2025 to the present
time that are reasonably likely to have a material adverse effect on our net revenue, income, profitability, liquidity or capital resources,
or that would cause the disclosed financial information to be not necessarily indicative of future operating results or financial condition.
E. Critical Accounting Estimates
Our consolidated financial statements are prepared in conformity
with IFRS, as issued by the IASB. The preparation of these historical financial statements in conformity with IFRS requires management
to make estimates, assumptions and judgments in certain circumstances that affect the reported amounts of assets, liabilities and contingencies
as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. We evaluate
our assumptions and estimates on an ongoing basis. We base our estimates on historical experience and on various other assumptions that
we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values
of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different
assumptions or conditions. Our critical accounting estimates are described in Note 2 to our consolidated financial statements included
elsewhere in this annual report.
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