Item 7. Management’s Discussion and Analysis
ITEM
7 - MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
FORWARD-LOOKING
STATEMENTS
Certain
statements contained herein this report constitute “forward-looking statements” within the meaning of the Private Securities
Litigation Reform Act of 1995 (the “1995 Reform Act”). Except for the historical information contained herein, this report
contains forward-looking statements (identified by words such as “estimate,” “project”, “anticipate”,
“plan”, “expect”, “intend”, “believe”, “hope”, “strategy” and
similar expressions), which are based on our current expectations and speak only as of the date made. These forward-looking statements
are subject to various risks, uncertainties and factors that could cause actual results to differ materially from the results anticipated
in the forward-looking statements.
Overview
Impact
Biomedical Inc. (“IBO”. “Impact”, “Impact BioMedical”, “we”, “us”, “our”
or the “Company”) discovers, confirms, and patents unique science and technologies which can be developed into new offerings
in human healthcare and wellness in collaboration with external partners through licensing, co-development, joint ventures, and other
relationships, and currently trades on the NYSE American under ticker symbol IBO.
By
leveraging technology and new science with strategic partnerships, we provide advances in biopharmaceuticals, over the counter direct
to consumer wellness offerings, and drug discovery for the prevention, inhibition, and treatment of neurological, oncologic, and inflammatory
diseases. In addition to our existing efforts, we continually search for, and evaluate, other potential new offerings to add to our portfolio.
Our
business model includes partnering and potentially direct sales for commercialization and distribution. Potential licensors and development
partners include pharmaceutical, consumer packaged goods companies and others, who would commercialize IBO technologies in exchange for
milestone, and royalty payments. Currently, our operations are conducted, and our assets are owned through our principal subsidiaries:
(i) Global BioLife, Inc. (“Global BioLife”), which was incorporated on April 14, 2017, (ii) Impact BioLife Science, Inc.
(“Impact BioLife”), which was incorporated on August 28, 2020, (iii) Global BioMedical, Inc. (“Global BioMedical”),
which was incorporated on April 18, 2017, and (iv) Sweet Sense, Inc. (“Sweet Sense”), which was incorporated on April 30,
2018.
Below
is a list of our principal subsidiaries:
●
Impact
BioLife Science, Inc.;
●
Global
Biomedical, Inc.;
●
Global
BioLife, Inc.; and
●
Sweet
Sense, Inc.
Impact
BioLife Science, Inc . We are the sole owner of the outstanding equity of Impact BioLife Science, Inc.
Global
Biomedical, Inc. We own 90.9% of Global Biomedical, Inc. outstanding equity.
Global
BioLife, Inc . Through our majority owned subsidiary Global Biomedical, Inc., we own 81.8% of the outstanding equity of Global
BioLife, Inc.
Sweet
Sense, Inc . We are the owner of 95.5% of the outstanding equity of Sweet Sense.
Impact
BioMedical has several unique and proprietary technologies that are in continuing development.
19
Linebacker
Linebacker
is a platform of small molecule electrophilically enhanced polyphenol compounds with potential application in oncology (solid tumors),
inflammatory disorders, and neurology. Polyphenols are substances found in many nuts, vegetables, and berries. Linebacker compounds are
modified Myricetin, which is a common plant-derived flavonoid. Myricetin exhibits a wide range of activities that include strong antioxidant
and anti-inflammatory activities (source: NIH).
Linebacker
can potentially be developed as monotherapy or co-therapy to down-regulate PIM (proviral integration site for Moloney murine leukemia
virus) kinase which plays a key role as an oncogene in various cancers (e.g. colon, lung, prostate, breast). Additional potential applications
include inflammatory disorders and neurology.
Linebacker-1
and Linebacker-2 compounds have been licensed to ProPhase Laboratories (NASDAQ: PRPH) for development and commercialization worldwide,
from which Impact Biomedical could receive future milestone and royalty payments.
Laetose
Laetose™
technology demonstrates compelling potential in reducing caloric intake and glycemic index in foods, while also inhibiting tumor necrosis
factor alpha (TNF-α), a cytokine associated with inflammatory chronic diseases (data on file with IBO).
The
patented formulation has potential to inhibit the inflammatory and metabolic response of sugar alone and has potential applications in
therapeutic administration to reduce or limit inflammatory or metabolic diseases (e.g., diabetes). Use of Laetose in a daily diet, compared
to sugar, could result in 30% lower sugar consumption and lower caloric and glycemic index/load.
Laetose
has a unique composition patent allowed in the United States and patents are pending in other countries worldwide.
IBO
is actively seeking potential partners for further development and commercialization of Laetose as a consumer-packaged or biopharmaceutical
offering worldwide.
Functional
Fragrance Formulation (“3F”)
3F
is a suite of “functional fragrances” containing specialized botanical ingredients (e.g., terpenes) with potential application
as an antimicrobial, or as an additive in insect repellents, detergents, lotions, shampoo, fabrics and other substances to increase effectiveness.
IBO
has partnered with the Chemia Corporation (St. Louis, MO) to pursue development of the 3F technology. Chemia is a leading developer and
manufacturer of fragrances and flavors.
In
addition to Chemia, IBO is actively seeking potential partners for further development and commercialization of 3F worldwide, given
the broad application of this technology.
Composition
patents have been issued in the U.S. and are pending in other countries.
Equivir
Equivir/Equivir
G technology is a novel blend of FDA Generally Recognized as Safe (GRAS) eligible polyphenols (e.g. Myricetin, Hesperetin, Piperine)
which have demonstrated antiviral effects with additional potential application as health supplements or medication. Polyphenols are
substances found in many nuts, vegetables, and berries. Myricetin is a member of the flavonoid class of polyphenolic compounds with antioxidant
properties. Hesperitin is a flavanone and Piperine is an alkaloid, commonly found in black pepper.
Equivir/Equivir
G is licensed to ProPhase Laboratories for development and commercialization worldwide. ProPhase Lab’s initial focus is for use
as an over-the-counter offering for upper respiratory wellness. Additional applications could be pursued in the future.
Method
and composition patents are issued in the U.S. and other countries.
Emerging
Technology
Impact
BioMedical continually evaluates additional proprietary technologies that are in various phases of development. These include, and are
not limited to biopharmaceuticals, indoor air quality products, preservatives, bioplastics, personalized medicine (e.g. genomics, diagnostics),
nanotechnology, cannabis products and technology, pain management, and others.
These
activities include discussions with potential companies/technologies which, subject to completion of diligence, and approval of the respective
management boards, could potentially expand the offerings of Impact Biomedical Inc. There is no assurance that anyone, or all, of these
will result in a material transaction and this is exemplary of consistent and ongoing search and discovery efforts within Impact Biomedical
Inc.
The
information in the two paragraphs below does not assume or give effect to (1) a 1:55 reverse split of the Company’s outstanding
common stock and (2) an exchange by a shareholder of common stock for Series A Convertible Preferred Stock.
20
The
Company was incorporated in the State of Nevada as a for-profit company on October 16, 2018, and established a fiscal year end of December
31st. The Company issued 9,000 shares to Global BioMedical Pte. Ltd., which was wholly–owned by Alset International Limited (formally
Singapore eDevelopment Limited), a multinational public company, listed on the Singapore Exchange Securities Trading Limited (“SGXST”).
On March 31, 2020, the Company issued 125,064,621 shares of common stock to its sole shareholder Global BioMedical Pte. Ltd. On July
24, 2020, the Board approved the Stock Split, pursuant to which each share of the Company’s common stock issued and outstanding
was split into nine shares of the Company’s common stock. The numbers of authorized common stock and issued and outstanding common
stock in the reporting periods were retrospectively adjusted for the stock split.
On
March 12, 2020 Alset International Limited (“Alset”), a related party, Global BioMedical Pte Ltd., a related party, DSS,
Inc (“DSS”), a related party, and DSS BioHealth Security Inc. (“DSS BioHealth”), a related party, signed Term
Sheets and subsequently on April 21, 2020, these four companies entered into Share Exchange Agreement (“Share Exchange”),
based on which Global BioMedical Pte Ltd., agreed to sell all of the issued and outstanding shares of the Company to DSS BioHealth in
exchange for the combination of common and preferred shares of DSS. Under the terms of the Share Exchange, DSS issued 483,334 shares
of the DSS Common Stock nominally valued at $6.48 per share, and 46,868 newly issued shares of the DSS Series A Convertible Preferred
Stock (“Series A Preferred Stock”), with a stated value of $46,868,000, or $1,000 per share, for a total consideration valued
at $50 million. Due to several factors, including a discount for illiquidity, the value of the Series A Preferred Stock was discounted
from $46,868,000 to $35,187,000, thus reducing the final consideration given to approximately $38,319,000. The Company’s Chairman,
Heng Fai Ambrose Chan, a related party, who is also the largest shareholder of Alset, at the time of the signing of the Share Exchange
Agreement was the beneficial owner of approximately 18.3% of the outstanding shares of DSS and is the Chairman of the Board of Directors
of DSS. On August 21, 2020, the transaction was concluded, and the Company became a direct wholly owned subsidiary of DSS BioHealth.
In connection with the acquisition, and the related accounting determination, DSS BioHealth has elected to apply push-down accounting
and reflect in its financial statements of Impact BioMedical, the fair value of its assets and liabilities. Utilizing an income approach,
the Company has completed its valuations of certain developed technology and pending patents assets acquired in the transaction as well
the fair value of the non-controlling interests. More specifically, a Multi-Period Excess Earnings Method (“MPEEM”) estimates
the value of an intangible asset by quantifying the amount of residual (or excess) estimated cash flows generated by the asset and discounting
those cash flows to the present. These have been valued at approximately $22,260,000 and $3,910,000, respectively, and are included on
the Consolidated Balance Sheet on December 31, 2020. Estimated useful life of these assets is twenty years, based on the remaining terms
of the related patents, with annual amortization approximating $1,113,000. The Company has also completed its valuation of goodwill and
deferred tax liabilities of Impact BioMedical, and has recorded goodwill of approximately $25,093,000, driven by other intangible assets
that do not qualify for separate recognition, and a deferred tax liability of approximately $5,234,000. The goodwill is not deductible
for tax purposes and has been allocated to Impact BioMedical in totality as a single reporting unit. The Company is committed to both
funding research and developing intellectual property portfolio.
Revenue
Year
ended
December
31, 2024
Year
ended
December
31, 2023
%
Change
Revenue
License revenue
$ -
$ -
NA
Total
Revenue
$ -
$ -
NA
Revenue
- The Company has not generated revenue for the years ended December 31,
2024 or 2023.
Costs
and expenses
Year
ended December 31, 2024
Year
ended December 31,2023
%
Change
Sales, general and administrative
compensation
$ 699,000
$ 315,000
122 %
Stock based compensation
19,000
-
N/A
Sales and marketing
633,000
65,000
874 %
Professional Fees
446,000
724,000
-38 %
Research and development
278,000
1,685,000
-84 %
Depreciation and Amortization
1,119,000
1,120,000
0 %
Rent and utilities
32,000
-
N/A
Impairment of fixed assets
263,000
-
N/A
Impairment of goodwill
25,093,000
-
N/A
Other operating expenses
171,000
119,000
44 %
Total
costs and expenses
$ 28,753,000
$ 4,028,000
614 %
21
Selling,
general and administrative compensation costs increased 122% for the year ended December 31, 2024, as compared to the year ended
December 31, 2023 due to increases in head count at the Company due to increased cost incurred associated with the Company’s registration
with the SEC and the NYSE American, and efforts toward the Company’s IPO.
Stock
based compensation includes expense charges for all stock-based awards to employees, directors, and consultants. Such awards can
include option grants, warrant grants, and restricted and unrestricted stock awards. These types of awards were not used prior to the
Company’s IPO in September 2024.
Sales
and marketing costs, which includes internet and trade publication advertising, travel and entertainment costs, sales-broker commissions,
and trade show participation expenses, increase 874% during 2024 as compared to 2023, primarily due to increased associated with cost
to attend trade shows and marketing efforts pre and post IPO
Professional
fees decreased 38% for the year ended December 31, 2024, as compared to year ended December 31, 2023. These costs consist primarily
of consulting and legal services associated with developing and implementing Impact BioMedical’s business plan, These costs decreased
in 2024 in anticipation of the Company’s IPO.
Research
and development costs represent costs consisting primarily of independent, third-party testing of the various properties of each
technology the Company owns possesses as well as research on new technologies. Research and development decreased 84% for the year ended
December 31, 2024, as compared to year ended December 31, 2023 due to several cost-cutting activities inclusive of the cessation of the
Company’s research and development contract with GRDG at the end of 2023.
Depreciation
and amortization expense remained flat for year ended December 31, 2024 compared to year ended December 31, 2023 and represents the
amortization of the associated with the developed technology and patents acquired as part of the acquisition of Impact BioMedical by
DSS. Amortization of these assets began on January 1, 2021, and will have a 20-year term.
Rent
and utilities represents cost associated with office space located at 1400 Broadfield Blvd, Suite 100 Houston TX which the Company
began subletting from DSS during the first quarter of 2024.
Impairment of fixed asset is
the impairment of marketing assets in development that the Company decided to forego completion.
Impairment
of goodwill during the 4th quarter of 2024, the Company performed qualitative and quantitative assessments of the goodwill value
associated with the Company determined that as of December 31, impairment was required (see Note 7).
Other
operating expenses consist primarily of office supplies, IT support, sales and marketing costs, travel and insurance costs. These
costs increased 44% for year ended December 31, 2024, as compared to year ended December 31, 2023, primarily due to increased IT support
and travel costs.
Other
Income (Expense)
Year
ended
December
31, 2024
Year
ended
December
31, 2023
%
Change
Interest income
$ 13,000
$ 13,000
0 %
Other income (expense)
-
52,000
-100 %
Change in fair value of note payable, related
party
5,068,000
-
N/A
Interest expense
(1,065,000 )
(444,000 )
140 %
Total
other income (expense)
$ 4,016,000
$ (379,000 )
1160 %
Interest
income is recognized on the Company’s notes receivables. Interest income remained flat for year ended December 31, 2024 as
compared to the year ended December 31, 2023 as the outstanding principal balance remained flat.
Other
income represents income generated from the Company’s distribution agreement with BioMed Technologies (“BioMed”).
during the first quarter of 2023. BioMed’s products focus on natural probiotics.
Change
in fair value of note payable, related party is related to the promissory note with DSS (“DSS Note”). During the fiscal
year ended 2024, the Company amended the terms of its outstanding principal balance of the DSS Note. Previously, the Note required repayment
solely in cash; however, pursuant to the second amendment executed which went into effect on September 16, 2024, the Company now has
the option to settle the Note in either cash or shares of the Company’s common stock, subject to certain conditions. In accordance with
ASC 480, Distinguishing Liabilities and Equity, and ASC 825, Financial Instruments, the Company remeasured the fair value
of the DSS Note as of the modification date and again as of December 31, 2024. As a result, the Company recognized a fair value adjustment
of $5,068,000 for the year ended December 31, 2024 (see Note 9).
Interest
expense is recognized on the Company’s debt to DSS increased year over year due to the increase in debt balance year over year.
Net
Loss
Year
ended
December
31, 2024
Year
ended
December
31, 2023
%
Change
Net
loss
$ (24,770,000 )
$ (4,407,000 )
-462 %
For
the year ended December 31, 2024, the Company recorded net loss of $24,770,000, as compared to a net loss of $4,407,000 for the year
ended December 31, 2023. The increase in net loss over year is attributable to the Company’s impairment of
goodwill as of December 31, 2024 offset by cost cutting measures in taken with both its professional and research and development
costs as the Company shifts efforts to taking to market its existing technologies as well as the change in fair value of with the
amended Note payable, related party.
Liquidity
and Capital Resources
The
Company has historically met its liquidity and capital requirements primarily through debt financing. On September 16, 2024, the Company
completed an initial public offering raising $3,726,000 net of issuance costs and is currently listed on the NYSE American under the
ticker symbol IBO. The Company’s management intends to take additional actions necessary to continue as a going concern. Management’s
plans concerning these matters include, among other things, monetization of its intellectual properties, and tightly controlling operating
costs.
22
Cash
Flow from Operating Activities
Net
cash used by continuing operating activities was $3,919,000 for the year ended December 31, 2024 as compared to cash used for
operating activities of $2,851,000 for the year ended December 31, 2023. This increase is driven by the increase in Operating loss
adjusted for reconciling items from operations of approximately $300,000 year over year as well as the decrease in accounts payable and
the increase of prepaid expenses and other current assets.
Cash
Flow from Investing Activities
Net
cash provided by investing activities was $2,000 for the year ended December 31, 2024 as compared to net cash used of $15,000 for the
year ended December 31, 2023. This fluctuation is driven by the purchase of property, plant and equipment of $18,000 during the year
ended December 31, 2023 without similar activities during 2024.
Cash
Flow from Financing Activities
Net
cash provided by financing activities for the year ended December 31, 2024 was $5,915,000 and represents $2,189,000 in borrowings from
DSS and $3,726,000 in proceeds from the Company’s IPO, net of issuances costs. Net cash provided by financing activities for the
year ended December 31, 2023 was $2,865,000 and represents borrowings from DSS.
Continuing
Operations and Going Concern
The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. This basis
of accounting contemplates the recovery of our assets and the satisfaction of liabilities in the normal course of business. As reflected
in the accompanying financial statements the Company has incurred operating losses as well as negative cash flows from operating activities over the past two years. These factors raise substantial doubt about the Company’s ability to continue as
a going concern within one year of the date that the financial statements are issued. These consolidated financial statements do not
include any adjustments to the specific amounts and classifications of assets and liabilities, which might be necessary should we be
unable to continue as a going concern.
To
continue as a going concern, the Company completed an initial public offering on September 16, 2024 raising $3,726,000 net of issuance
costs and is currently listed on the NYSE American under the ticker symbol IBO. The Company’s management intends to take additional
actions necessary to continue as a going concern. Management’s plans concerning these matters include, among other things, monetization
of its intellectual properties, and tightly controlling operating costs.
Off-Balance
Sheet Arrangements
We
do not have any off-balance sheet arrangements that have, or are reasonably likely to have, an effect on our financial condition, financial
statements, revenues or expenses.
Inflation
Although
our operations are influenced by general economic conditions, we do not believe that inflation had a material effect on our results of
operations during 2024 or 2023.
Critical
Accounting Policies
The
preparation of financial statements and related disclosures in conformity with U.S. GAAP requires management to make judgments, assumptions
and estimates that affect the amounts reported in our financial statements and accompanying notes. The financial statements as of December
31, 2024, describe the significant accounting policies and methods used in the preparation of the financial statements. There have been
no material changes to such critical accounting policies as of the Annual Report on Form 10-K for the year ended December 31, 2024.
23
Fair
Value of Financial Instruments
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. The Fair Value Measurement Topic of the Financial Accounting Standards Board (“FASB”)
Accounting Standards Codification (“ASC”) establishes a three-tier fair value hierarchy which prioritizes the inputs used
in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets
or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include:
●
Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets.
●
Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted
prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active;
and
●
Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions,
such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable.
The
carrying amounts reported in the balance sheet of cash and cash equivalents, prepaids, accounts payable and accrued expenses approximate
fair value because of the immediate or short-term maturity of these financial instruments. The fair value of notes receivable approximates
their carrying value as the stated or discounted rates of the notes do reflect recent market conditions. The Company’s investments
are recorded at cost as the fair value of these investment in is not readily available. The fair value of notes payable approximates
its carrying value as the stated interest rate reflects recent market conditions.
Investments
Investments
in equity securities with a readily determinable fair value, not accounted for under the equity method, are recorded at fair value with
unrealized gains and losses included in earnings. For equity securities without a readily determinable fair value, the investment is
recorded at cost, less any impairment, plus or minus adjustments related to observable transactions for the same or similar securities,
with unrealized gains and losses included in earnings.
For
equity method investments, the Company regularly reviews its investments to determine whether there is a decline in fair value below
book value. If there is a decline that is other-than-temporary, the investment is written down to fair value.
Goodwill
Goodwill
is the excess of cost of an acquired entity over the fair value of amounts assigned to assets acquired and liabilities assumed in a business
combination. Goodwill is subject to impairment testing at least annually and will be tested for impairment between annual tests if an
event occurs or circumstances change that would indicate the carrying amount may be impaired. FASB ASC Topic 350 provides an entity with
the option to first assess qualitative factors to determine whether the existence of events or circumstances leads to a determination
that it is more likely than not that the fair value of a reporting unit is less than its carrying amount. Some of the qualitative factors
considered in applying this test include consideration of macroeconomic conditions, industry and market conditions, cost factors affecting
the business, and overall financial performance of the business. If, after completing the assessment, it is determined that it is more
likely than not that the fair value of a reporting unit is less than its carrying value, the Company will proceed to a quantitative test.
If qualitative factors are not deemed sufficient to conclude that the fair value of the reporting unit more likely than not exceeds its
carrying value, then a one-step approach is applied in making an evaluation. The evaluation utilizes multiple valuation methodologies,
including a market approach (market price multiples of comparable companies) and an income approach (discounted cash flow analysis).
The computations require management to make significant estimates and assumptions, including, among other things, selection of comparable
publicly traded companies, the discount rate applied to future earnings reflecting a weighted average cost of capital, and earnings growth
assumptions. The Company believes the estimates and assumptions used in our impairment assessments are reasonable and based on available
market information, but variations in any of the assumptions could result in materially different calculations of fair value and determinations
of whether or not an impairment is indicated. A discounted cash flow analysis requires management to make various assumptions about future
sales, operating margins, capital expenditures, working capital, and growth rates. Cash flow projections are derived from one-year budgeted
amounts plus an estimate of later period cash flows, all of which are determined by management. Subsequent period cash flows are developed
for each reporting unit using growth rates that management believes are reasonably likely to occur. Impairment of goodwill is measured
as the excess of the carrying amount of goodwill over the fair values of recognized and unrecognized assets and liabilities of the reporting
unit. Impairment testing was performed as of December 31, 2024 and the Company deemed it appropriate to fully impair goodwill as of December
31, 2024.
24
Intangible
Assets
The
estimated fair values of acquired intangibles are generally determined based upon future economic benefits such as earnings and cash
flows. Acquired identifiable intangible assets are recorded at fair value and are amortized over their estimated useful lives. Acquired
intangible assets with an indefinite life are not amortized but are reviewed for impairment at least annually as of December 31 st ,
or more frequently whenever events or changes in circumstances indicate that the carrying amounts of those assets are below their estimated
fair values. Impairment is tested under ASC 350. No impairment was recognized as of December 31, 2024 or year ended December 31, 2023.
Continuing
Operations and Going Concern
The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. This basis
of accounting contemplates the recovery of our assets and the satisfaction of liabilities in the normal course of business. As reflected
in the accompanying financial statements the Company has incurred operating losses as well as negative cash flows from operating activities
over the past two years. These factors raise substantial doubt about the Company’s ability to continue as a going concern within
one year of the date that the financial statements are issued. These consolidated financial statements do not include any adjustments
to the specific amounts and classifications of assets and liabilities, which might be necessary should we be unable to continue as a
going concern.
To
continue as a going concern, the Company completed an initial public offering on September 16, 2024 raising $3,726,000 net of issuance
costs and is currently listed on the NYSE American under the ticker symbol IBO. The Company’s management intends to take additional
actions necessary to continue as a going concern. Management’s plans concerning these matters include, among other things, monetization
of its intellectual properties, and tightly controlling operating costs.
Revenue
The
Company has adopted ASC Topic 606 , Revenue from Contracts with Customers (“Topic 606”). The Company enters
into licensing and development agreements with collaborators for the development of its technologies. The terms of these agreements contain
multiple performance obligations which may include (i) licenses, or options to obtain licenses, to the Company’s technology, (ii)
rights to future technological improvements, and/or (iii) research activities to be performed on behalf of the collaborative partner,
Payments to the Company under these agreements may include upfront fees, option fees, exercise fees, payments based upon the achievement
of certain milestones, and royalties on product sales. Revenue is recognized when a customer obtains control of promised goods or services,
in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. In determining
the appropriate amount of revenue to be recognized as it fulfills its obligations under the agreements, the Company performs the following
steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services
are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction
price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and
(v) recognition of revenue when or as the Company satisfies each performance obligation.
The
Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration to which it
is entitled in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined
to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that
are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the
amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied.
ITEM
7A - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
applicable.
25
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