UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C.
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended April 30, 2023
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from __________ to __________
Commission
File Number 000-55654
NUTRIBAND
INC.
(Exact
name of registrant as specified in its charter)
NEVADA 81-1118176
(State or other jurisdiction of
incorporation or organization) (I.R.S. Employer
Identification No.)
121 South Orange Ave ., Suite 1500 , Orlando , FL 32801
(Address of Principal Executive Offices) (Zip Code)
(407)
377-6695
(Registrant’s
Telephone Number, Including Area Code)
Securities
registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which
registered
Common Stock NTRB The Nasdaq Stock Market LLC
Warrants NTRBW The Nasdaq Stock Market LLC
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☐ No ☒
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company,
or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ Accelerated filer ☐
Non-accelerated filer ☒ Smaller reporting company ☒
Emerging growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The
number of shares outstanding of the issuer’s common stock, par value $0.001 per share, was 7,833,150 shares as of June 9, 2023.
NUTRIBAND
INC.
INDEX
Page
No.
Part
I: Financial Information
Item 1
Financial Statements
1
Condensed Consolidated Balance Sheets as of April 30, 2023 (unaudited) and January 31, 2023
2
Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended April 30, 2023, and 2022 (unaudited)
3
Consolidated Statements of Stockholders’ Equity for the three months ended April 30, 2023, and 2022 (unaudited)
4
Condensed Consolidated Statements of Cash Flows for the Nine months ended April 30, 2023, and 2022 (unaudited)
5
Notes to Unaudited Condensed Consolidated Financial Statements
6
Item 2
Management’s Discussion and Analysis of Financial Condition and Results of Operations
18
Item 3
Quantitative and Qualitative Disclosures about Market Risk
23
Item 4
Controls and Procedures
23
Part
II: Other Information
24
Item 1A
Risk Factors
24
Item 6
Exhibits
26
i
PART
I. FINANCIAL INFORMATION
ITEM
1. FINANCIAL STATEMENTS
Certain
information and footnote disclosures required under accounting principles generally accepted in the United States of America have been
condensed or omitted from the following financial statements pursuant to the rules and regulations of the Securities and Exchange Commission.
The results of operations for the three months
ended April 30, 2023, and 2022 are not necessarily indicative of the results for the entire fiscal year or for any other period.
1
NUTRIBAND
INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
April 30,
January 31,
2023
2023
(Unaudited)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
1,278,075
$
1,985,440
Accounts receivable
164,641
113,045
Inventory
181,497
229,335
Prepaid expenses
369,279
365,925
Total Current Assets
1,993,492
2,693,745
PROPERTY & EQUIPMENT-net
853,445
897,735
OTHER ASSETS:
Goodwill
5,021,713
5,021,713
Operating lease right of use asset
54,909
62,754
Intangible assets-net
752,143
780,430
TOTAL ASSETS
$
8,675,702
$
9,456,377
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses
$
543,753
$
534,679
Deferred revenue
188,697
162,903
Operating lease liability-current portion
32,012
31,291
Notes payable-current portion
19,931
19,740
Total Current Liabilities
784,393
748,613
LONG-TERM LIABILITIES:
Note payable-net of current portion
95,429
100,497
Note payable-related party
50,000
—
Operating lease liability-net of current portion
25,999
34,277
Total Liabilities
955,821
883,387
Commitments and Contingencies
-
-
STOCKHOLDERS’ EQUITY:
Preferred stock, $ .001 par value, 10,000,000 shares authorized, - 0 - outstanding
-
-
Common stock, $ .001 par value, 291,666,666 shares authorized; 7,843,150 shares issued at April 30, 2023 and January 31, 2023 and 7,833,150 shares outstanding as of April 30,2023 and January 31, 2023, respectively
7,833
7,833
Additional paid-in-capital
31,254,927
31,092,807
Accumulated other comprehensive loss
( 304
)
( 304
)
Treasury stock, 10,000 and 10,000 shares at cost, respectively
( 32,641
)
( 32,641
)
Accumulated deficit
( 23,509,934
)
( 22,494,705
)
Total Stockholders’ Equity
7,719,881
8,572,990
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$
8,675,702
$
9,456,377
See notes to unaudited consolidated financial statements
2
NUTRIBAND
INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
For the Three Months Ended
April 30,
2023
2022
Revenue
$
476,932
$
477,922
Costs and expenses:
Cost of revenues
254,648
277,436
Research and development
400,430
117,814
Selling, general and administrative
839,732
768,551
Total Costs and Expenses
1,494,810
1,163,801
Loss from operations
( 1,017,878
)
( 685,879
)
Other income (expense):
Interest income
5,815
-
Interest expense
( 3,166
)
( 4,110
)
Total other income (expense)
2,649
( 4,110
)
Loss before provision for income taxes
( 1,015,229
)
( 689,989
)
Provision for income taxes
-
-
Net loss
$
( 1,015,229
)
$
( 689,989
)
Net loss per share of common stock-basic and diluted
$
( 0.13
)
$
( 0.08
)
Weighted average shares of common stock outstanding - basic and diluted
7,833,150
9,183,249
Other Comprehensive Loss:
Net loss
$
( 1,015,229
)
$
( 689,989
)
Foreign currency translation adjustment
-
-
Total Comprehensive Loss
$
( 1,015,229
)
$
( 689,989
)
See notes to unaudited consolidated financial statements.
3
NUTRIBAND
INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
Three
Months Ended April 30, 2023
Accumulated
Common Stock
Additional
Other
Number of
Paid In
Comprehensive
Accumulated
Treasury
Total
shares
Amount
Capital
Loss
Deficit
Stock
Balance, February 1, 2023
$ 8,572,990
7,833,150
$ 7,833
$ 31,092,807
$ ( 304 )
$ ( 22,494,705 )
$ ( 32,641 )
Warrants issued for services
87,090
-
-
87,090
-
-
-
Options issued for services
75,030
-
-
75,030
-
-
-
Net loss for the three months ended April 30, 2023
( 1,015,229 )
-
-
-
-
( 1,015,229 )
-
Balance, April 30, 2023
$ 7,719,881
7,833,150
$ 7,833
$ 31,254,927
$ ( 304 )
$ ( 23,509,934 )
$ ( 32,641 )
Three
Months Ended April 30, 2022
Accumulated
Common Stock
Additional
Other
Number of
Paid In
Comprehensive
Accumulated
Treasury
Total
shares
Amount
Capital
Income(Loss)
Deficit
Stock
Balance, February 1, 2022
$ 11,859,285
9,150,440
$ 9,150
$ 29,966,137
$ ( 304 )
$ ( 18,011,231 )
$ ( 104,467 )
Treasury stock repurchased
$ ( 89,196 )
( 26,836 )
( 27 )
27
-
( 89,196 )
Net loss for the three months ended April 30, 2022
( 689,989 )
-
-
-
-
( 689,989 )
-
Balance, April 30, 2022
$ 11,080,100
9,123,604
$ 9,123
$ 29,966,164
$ ( 304 )
$ ( 18,701,220 )
$ ( 193,663 )
See notes to unaudited consolidated financial
statements.
4
NUTRIBAND
INC. AND SUBSIDIARIES
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Three Months Ended
April 30,
2023
2022
Cash flows from operating activities:
Net loss
$ ( 1,015,229 )
$ ( 689,989 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
75,201
77,475
Amortization of right of use asset
7,845
14,985
Stock-based compensation-warrants
87,090
-
Stock-based compensation-options
75,030
-
Changes in operating assets and liabilities:
Accounts receivable
( 51,596 )
( 27,718 )
Prepaid expenses
( 3,354 )
( 28,744 )
Inventories
47,838
4,115
Deferred revenue
25,794
23,719
Operating lease liability
( 7,557 )
( 14,001 )
Accounts payable and accrued expenses
9,074
( 104,099 )
Net Cash Used In Operating Activities
( 749,864 )
( 744,257 )
Cash flows from investing activities:
Purchase of equipment
( 2,624 )
( 43,803 )
Net Cash Used in Investing Activities
( 2,624 )
( 43,803 )
Cash flows from financing activities:
Proceeds from line of credit
50,000
-
Payment on note payable
( 4,877 )
( 3,968 )
Purchase of treasury stock
-
( 89,196 )
Net Cash Provided by (used in) Financing Activities
45,123
( 93,164 )
Effect of exchange rate on cash
-
-
Net change in cash
( 707,365 )
( 881,224 )
Cash and cash equivalents - Beginning of period
1,985,440
4,891,868
Cash and cash equivalents - End of period
$ 1,278,075
$ 4,010,644
Supplementary information:
Cash paid for:
Interest
$ 1,725
$ 4,110
Income taxes
$ -
$ -
Supplemental disclosure of non-cash investing and financing activities:
Adoption of ASC 842 Operating lease asset and liability
$ -
$ 94,134
Promissory note on equipment purchase
$ -
$ 22,483
See notes to unaudited consolidated financial statements.
5
NUTRIBAND
INC. AND SUBSIDIARIES
Notes
to Unaudited Consolidated Financial Statements
as
of and for the Three Months Ended April 30, 2023 and 2022
1. ORGANIZATION
AND DESCRIPTION OF BUSINESS
Organization
Nutriband
Inc. (the “Company”) is a Nevada corporation, incorporated on January 4, 2016. In January 2016, the Company acquired Nutriband
Ltd, an Irish company which was formed by the Company’s chief executive officer in 2012 to enter the health and wellness market
by marketing transdermal patches. References to the Company relate to the Company and its subsidiaries unless the context indicates otherwise.
On
August 1, 2018, the Company acquired 4P Therapeutics LLC (“4P Therapeutics”) for $2,250,000, consisting of 250,000 shares
of common stock, valued at $1,850,000, and $400,000, and a royalty of 6% on all revenue generated by the Company from the abuse deterrent
intellectual property that had been developed by 4P Therapeutics payable to the former owner of 4P Therapeutics. The former owner of
4P Therapeutics has been a director of the Company since April 2018, when the Company entered into an agreement to acquire 4P Therapeutics.
The former owner resigned as a director in January 2022.
4P
Therapeutics is engaged in the development of a series of transdermal pharmaceutical products, that are in the preclinical stage of development.
Prior to the acquisition of 4P Therapeutics, the Company’s business was the development and marketing of a range of transdermal
consumer patches. Most of these products are considered drugs in the United States and cannot be marketed in the United States without
approval by the Food and Drug Administration (the “FDA”). The Company entered a feasibility agreement as an initial step
to seek FDA approval of its consumer transdermal products and its consumer products which are not being marketed in the United States.
With
the acquisition of 4P Therapeutics, 4P Therapeutics’ drug development business became the Company’s principal business. The
Company’s approach is to use generic drugs that are off patent and incorporate them into the Company’s transdermal drug delivery
system. Although these medications have received FDA approval in oral or injectable form, the Company needs to conduct a transdermal
product development program which will include the preclinical and clinical trials that are necessary to receive FDA approval before
we can market any of our pharmaceutical products.
On
August 25, 2020, the Company formed Pocono Pharmaceuticals Inc. (“Pocono Pharmaceuticals”), a wholly owned subsidiary of
the Company. On August 31, 2020, the Company acquired certain assets and liabilities associated with the Transdermal, Topical, Cosmetic,
and Nutraceutical business of Pocono Coated Products LLC (“PCP”). The net assets were contributed to Pocono Pharmaceuticals.
Included in the transaction, Pocono Pharmaceuticals also acquired 100 % of the membership interests of Active Intelligence LLC (“Active
Intelligence”).
Pocono Pharmaceuticals
is a coated products manufacturing entity organized to take advantage of unique process capabilities and experience. Pocono helps their
customers with product design and development along with manufacturing to bring new products to market with minimal capital investment.
Pocono Pharmaceutical’s competitive edge is a low-cost manufacturing base: a result of its unique processes and state-of-the-art
material technology. Active Intelligence manufactures activated kinesiology tape. The tape has transdermal and topical properties. This
tape is used the same as traditional kinesiology tape.
In
December 2019, COVID-19 emerged and has subsequently spread world-wide. The World Health Organization has declared COVID-19 a pandemic
resulting in federal, state and local governments and private entities proscribing various restrictions, including travel restrictions,
restrictions on public gatherings, stay at home orders and advisories and quarantining people who may have been exposed to the virus.
The effect of these orders, government imposed quarantines and measures the Company and suppliers and customers it works with might have
to take, such as work-at-home policies, may negatively impact productivity, disrupt our business and could delay our clinical programs
and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and disruptions in our operations,
operating results and financial condition. Further, quarantines, shelter-in-place and similar government orders, or the perception that
such orders, shutdowns, or other restrictions on the conduct of business could occur, related to COVID-19 or other infectious diseases
could impact personnel at third-party manufacturing facilities in the United States and other countries, or the availability or cost
of materials, which could disrupt our supply chain.
2. SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
Unaudited
Financial Statements
The
consolidated balance sheet as of April 30, 2023, and the consolidated statements of operations and comprehensive loss, stockholders’
equity, and cash flows for the periods presented have been prepared by the Company and are unaudited. In the opinion of management, all
adjustments (consisting solely of normal recurring adjustments) necessary to present fairly the financial position, results of operations,
changes in stockholders’ equity and cash flows for all periods presented have been made. The results for the three months ended
April 30, 2023, are not necessarily indicative of the results to be expected for the full year. The consolidated financial statements
should be read in conjunction with the consolidated financial statements and footnotes thereto included in Nutriband’s Annual Report
on Form 10-K for the year ended January 31, 2023.
6
Certain
information and footnote disclosures required under generally accepted accounting principles in the United States of America (“U.S.
GAAP”) have been condensed or omitted from these consolidated financial statements pursuant to the rules and regulations, including
interim reporting requirements of the U.S. Securities and Exchange Commission (“SEC”). The preparation of consolidated financial
statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts and the
disclosures of contingent amounts in our consolidated financial statements and accompanying footnotes. Actual results could differ from
estimates.
The Company’s
significant accounting policies in Note 2 in the Company’s Annual Report on Form 10-K for the year ended January 31, 2023. There
were no significant changes to these accounting policies during the three months ending April 30, 2023.
Forward
Stock Split
On July 26,
2022, our Board of Directors approved the amendment to our Articles of Incorporation to affect a 7 for 6 forward stock split (the “Stock
Split”) of our outstanding common stock. The Company filed the amendment set forth in a Certificate of Change with the Secretary
of State of Nevada on August 4, 2022. The 7:6 forward stock split was effective for trading purposes on the Nasdaq Capital Market on August
12, 2022. Each shareholder of record as of the August 15, 2022, record date received one (1) additional share for each six (6) shares
held as of the record date. No fractional shares of common stock were issued in connection with the Stock Split. Instead, all shares were
rounded up to the next whole share. In connection with the Stock Split, which did not require shareholder approval under the Nevada corporation
law, the number of shares of common stock of the Company was increased in the same ratio as the shares of outstanding common stock were
increased in the Stock Split, from 250,000,000 authorized shares to 291,666,666 authorized shares.
All
share and per share information in these financial statements retroactively reflect the forward stock split.
Going
Concern Assessment
Management
assesses liquidity and going concern uncertainty in the Company’s condensed financial statements to determine whether there is
sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from
the date the consolidated financial statements are issued or available to be issued, which is referred to as the “look-forward
period”, as defined in GAAP. As part of this assessment, based on conditions that are known and reasonably knowable to management,
management will consider various scenarios, forecasts, projections, estimates and will make certain key assumptions, including timing
and nature of projected cash expenditures or programs, its ability to delay or curtail expenditures or programs and its ability to raise
additional capital, if necessary, among other factors. Based on this assessment, as necessary or applicable, management makes certain
assumptions around implementing curtailments or delays in the nature and timing of programs and expenditures to the extent it deems probable
those implementations can be achieved and management has the proper authority to execute them within the look-forward period.
As of April
30, 2023, the Company had cash and cash equivalents of $ 1,278,075 and working capital of $ 1,209,099 . For the three months ended April
30, 2023, the Company incurred an operating loss of $ 1,015,229 and used cash flow from operations of $ 749,864 . The Company has generated
operating losses since its inception and has relied on sales of securities and issuance of third-party and related-party debt to support
cash flow from operations. In October 2021, the Company consummated a public offering and received net proceeds of $ 5,836,230 . The Company
also received to date $ 3,239,845 proceeds from the exercise of warrants. The Company has used these proceeds to fund operations and will
continue to use the funds as needed. In March 2023, the Company entered a three-year $ 2,000,000 Credit Line Note facility which will permit
the Company to draw down on the credit line to fund the Company’s research and development of its Aversa product.
Management
has prepared estimates of operations for the next twelve months and believes that sufficient funds will be generated from operations
to fund its operations for one year from the date of the filing of these condensed consolidated financial statements, which indicates
improved operations and the Company’s ability to continue operations as a going concern. The impact of COVID-19 on the Company’s
business has been considered in these assumptions; however, it is too early to know the full impact of COVID-19 or its timing on a return
to normal operations.
Management
believes the substantial doubt about the ability of the Company to continue as a going concern is alleviated by the above assessment.
Principles
of Consolidation
The consolidated
financial statements of the Company include the Company and its wholly owned subsidiaries. All material intercompany balances and transactions
have been eliminated. The operations of 4P Therapeutics are included in the Company’s financial statements from the date of acquisition
of August 1, 2018, and the operations of Pocono and Active Intelligence are included in the Company’s financial statements from
the date of acquisition of September 1, 2020, under Pocono Pharmaceuticals Inc. The wholly owned subsidiaries are as follows:
Nutriband
Ltd.
4P
Therapeutics LLC
Pocono
Pharmaceuticals Inc.
7
Use
of Estimates
The
preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States
of America requires the Company to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and
expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates including,
but not limited to, those related to such items as income tax exposures, accruals, depreciable/useful lives, allowance for doubtful accounts
and valuation allowances. The Company bases its estimates on historical experience and on other various assumptions that are believed
to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets
and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates.
Revenue
Recognition
In
May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which
amends the accounting standards for revenue recognition. ASU 2014-09 is based on principles that govern the recognition of revenue at
an amount an entity expects to be entitled when products are transferred to a customer. The Company recognizes revenue based on the five
criteria for revenue recognition established under Topic 606: 1) identify the contract, 2) identify separate performance obligations,
3) determine the transaction price, 4) allocate the transaction price among the performance obligations, and 5) recognize revenue as
the performance obligations are satisfied.
Revenue
Types
The
following is a description of the Company’s revenue types, which include professional services and sale of goods:
● Service
revenues include the contract of research and development related services with the Company’s clients in the life sciences field
on an as-needed basis. Deliverables primarily consist of detailed findings and conclusion reports provided to the client for each given
research project engaged.
● Product
revenues are derived from the sale of the Company’s consumer transdermal and coated
products. Upon the reception of a purchase order, we have the order filled and shipped.
Contracts
with Customers
A
contract with a customer exists when (i) we enter into an enforceable contract with a customer that defines each party’s rights
regarding the goods or services to be transferred and identifies the payment terms related to these goods or services, (ii) the contract
has commercial substance and, (iii) we determine that collection of substantially all consideration for services that are transferred
is probable based on the customer’s intent and ability to pay the promised consideration.
Contract
Liabilities
Deferred
revenue is a liability related to a revenue producing activity for which revenue has not been recognized. The Company records deferred
revenue when it receives consideration from a contract before achieving certain criteria that must be met for revenue to be recognized
in conformity with GAAP.
Performance
Obligations
A
performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in
the new revenue standard. The contract transaction price is allocated to each distinct performance obligation and recognized as revenue
when, or as, the performance obligation is satisfied. For the Company’s different revenue service types, the performance obligation
is satisfied at different times. The Company’s performance obligations include providing products and professional services in
the area of research. The Company recognizes product revenue performance obligations in most cases when the product has shipped to the
customer. When we perform professional service work, we recognize revenue when we have the right to invoice the customer for the work
completed, which typically occurs over time on a monthly basis for the work performed during that month.
All
revenue recognized in the income statement is considered to be revenue from contracts with customers.
8
Disaggregation
of Revenues
The
Company disaggregates its revenue from contracts with customers by type and by geographical location. See the tables:
Three Months Ended
April 30,
2023
2022
Revenue by type
Sale of goods
$ 401,057
$ 401,990
Services
75,875
75,932
Total
$ 476,932
$ 477,922
Three Months Ended
April 30,
2023
2022
Revenue by geographic location:
United States
$ 476,932
$ 477,922
Foreign
-
-
$ 476,932
$ 477,922
Accounts
receivable
Trade accounts
receivables are recorded at the net invoice value and are not interest bearing. The Company maintains allowances for doubtful accounts
for estimated losses from the inability of its customers to make the required payments. The Company determines its allowances by both
the specific identification of customer accounts where appropriate and the application of historical loss to non-applicable accounts.
For the three months ended April 30, 2023, and 2022, the Company recorded no bad debt expense for doubtful accounts related to account
receivable.
Inventories
Inventories
are valued at the lower of cost and reasonable value determined using the first-in, first-out (FIFO) method. The net realized value is
the estimated selling price in the ordinary course of business, less applicable variable selling expenses. The cost of finished goods
and work in process is comprised of material costs, direct labor costs and other direct costs and related production overheads (based
on normal operating capacity). As of April 30, 2023, total inventory was $ 181,497 , consisting of work-in-process of $ 41,432 and raw materials
of $ 140,064 . As of January 31, 2023, total inventory was $ 229,335 , consisting of work-in-process of $ 11,021 and raw materials of $ 218,334 .
Property,
Plant and Equipment
Property
and equipment represent an important component of the Company’s assets. The Company depreciates its plant and equipment on a straight-line
basis over the estimated useful life of the assets. Property, plant and equipment is stated at historical cost. Expenditures for minor
repairs, maintenance and replacement parts which do not increase the useful lives of the assets are charged to expense as incurred. All
major additions and improvements are capitalized. Depreciation is computed using the straight-line method. The lives over which the fixed
assets are depreciated range from 3 to 20 years as follows:
Lab
Equipment
5 - 10 years
Furniture and fixtures
3 years
Machinery
and equipment
10 - 20 years
Intangible
Assets
Intangible
assets include trademarks, intellectual property and customer base acquired through business combinations. The Company accounts for Other
Intangible Assets under the guidance of ASC 350, “Intangibles-Goodwill and Other.” The Company capitalizes certain costs related
to patent technology. A substantial component of the purchase price related to the Company’s acquisitions has also been assigned
to intellectual property and other intangibles. Under the guidance, other intangible assets with definite lives are amortized over their
estimated useful lives. Intangible assets with indefinite lives are tested annually for impairment. Trademarks, intellectual property,
and customer base are being amortized over their estimated useful lives of ten years .
Goodwill
Goodwill represents
the difference between the total purchase price and the fair value of assets (tangible and intangible) and liabilities at the date of
acquisition. Goodwill is reviewed for impairment annually on January 31, and more frequently as circumstances warrant, and written down
only in the period in which the recorded value of such assets exceeds their fair value. The Company does not amortize goodwill in accordance
with ASC 350. In connection with the Company’s acquisition of 4P Therapeutics LLC in 2018, the Company recorded Goodwill of $ 1,719,235 .
On August 31, 2020, in connection with the Company’s acquisition of Pocono Coated Products LLC and Active Intelligence LLC, the
Company recorded Goodwill of $ 5,810,640 . During the years ended January 31, 2023, and 2022, the Company recorded an impairment charge
of $ 327,326 and $ 2,180,836 , respectively, reducing the Active Intelligence LLC Goodwill to $ 3,302,478 . As of April 30, 2023, and January
31, 2023, Goodwill amounted to $ 5,021,713 and $ 5,021,713 , respectively.
9
Long-lived
Assets
Management
reviews long-lived assets for potential impairment whenever significant events or changes in circumstances indicate that the carrying
amount of an asset may not be recoverable. An impairment exists when the carrying amount of the long-lived asset is not recoverable and
exceeds its fair value. The carrying amount of a long-lived asset is not recoverable if it exceeds the sum of the estimated undiscounted
cash flows expected to result from the use and eventual disposition of the asset. If an impairment exists, the resulting write-down would
be the difference between the fair market value of the long-lived asset and the related book value.
Earnings
per Share
Basic
earnings per share of common stock is computed by dividing net earnings by the weighted average number of shares of common stock outstanding
during the period. Diluted earnings per share is computed by dividing net earnings by the weighted average number of shares
of common stock and potential shares of common stock outstanding during the period. Potential shares of common stock consist of
shares issuable upon the exercise of outstanding options and common stock purchase warrants. As of April 30, 2023, and 2022, there were
1,783,373 and 1,626,373 common stock equivalents outstanding, that were not included in the calculation of dilutive earnings per share
as their effect would be anti-dilutive.
Stock-Based
Compensation
ASC
718, “Compensation - Stock Compensation,” prescribes accounting and reporting standards for all share-based payment
transactions in which employee services, and, since February 1, 2019, non-employees, are acquired. Transactions include incurring
liabilities, or issuing or offering to issue shares, options, and other equity instruments such as employee stock ownership plans
and stock appreciation rights. Share-based payments to employees, including grants of employee stock options, are recognized as
compensation expense in the financial statements based on their fair values. That expense is recognized over the period during which
an employee is required to provide services in exchange for the award, known as the requisite service period (usually the vesting
period). As of February 1, 2019, pursuant to ASC 2018-07, ASC 718 was applied to stock-based compensation for both employees and
non-employees.
Business
Combinations
The
Company recognizes the assets acquired, the liabilities assumed, and any non-controlling interest in the acquired entity at the acquisition
date, measured at their fair values as of that date, with limited exceptions specified in the accounting literature. In accordance with
this guidance, acquisition-related costs, including restructuring costs, must be recognized separately from the acquisition and will
generally be expensed as incurred. That replaces the cost-allocation process detailed in previous accounting literature, which required
the cost of an acquisition to be allocated to the individual assets acquired and liabilities assumed based on their estimated fair value.
Leases
In
February 2016, the FASB issued ASU 2016-02, “Leases” (Topic 842), to provide a new comprehensive model for lease accounting
under this guidance, lessees and lessors should apply a “right-of-use” model in accounting for all leases (including subleases)
and eliminate the concept of operating leases and off-balance-sheet leases. Recognition, measurement, and presentation of expenses will
depend on classification as a finance or operating lease. Similar modifications have been made to lessor accounting in-line with revenue
recognition guidance.
The
Company applies guidance for right-of-use accounting for all leases and records the operating lease liabilities on its balance sheet.
The Company completed the necessary changes to its accounting policies, processes, disclosure, and internal control over financial reporting.
Research
and Development Expenses
Research
and development costs are expensed as incurred.
Income
Taxes
Taxes
are calculated in accordance with taxation principles currently effective in the United States and Ireland.
The
Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities
for the expected future tax consequences of events that have been included in the financial statements. Under this method,
deferred tax assets and liabilities are determined based on the differences between the financial statements and tax basis of assets
and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect
of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date.
10
The Company
records net deferred tax assets to the extent they believe these assets will more likely than not be realized. In making such
determination, the Company considers all available positive and negative evidence, including future reversals of existing taxable temporary
differences, projected future taxable income, tax planning strategies and recent financial operations. In the event the Company
was to determine that it would be able to realize its deferred income tax assets in the future in excess of its net recorded amount, the
Company would make an adjustment to the valuation allowance which would reduce the provision for income taxes.
Fair
Value Measurements
FASB
ASC 820, “Fair Value Measurements and Disclosure” (“ASC 820”), defines fair value as the exchange price that
would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset
or liability in an orderly transaction between participants on the measurement date. ASC 820 also establishes a fair value hierarchy
which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
ASC 820 describes three levels of inputs that may be used to measure fair value.
The
Company utilizes the accounting guidance for fair value measurements and disclosures for all financial assets and liabilities and nonfinancial
assets and liabilities that are recognized or disclosed at fair value in the consolidated financial statements on a recurring basis during
the reporting period. The fair value is an exit price, representing the price that would be received to sell an asset or paid to transfer
a liability in an orderly transaction between market participants based upon the best use of the asset or liability at the measurement
date. The Company utilizes market data or assumptions that market participants would use in pricing the asset or liability. ASC 820 establishes
a three-tier value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers are defined as follows:
Level
1 -
Observable inputs such as quoted
market prices in active markets.
Level
2 -
Inputs other than quoted prices in active markets
that are either directly or indirectly observable.
Level
3 -
Unobservable inputs about which little or no market
data exists, therefore requiring an entity to develop its own assumptions.
The
carrying value of the Company’s financial instruments, including accounts receivable, prepaid expenses, accounts payable and accrued
expenses, and deferred revenue approximate their fair value due to the short maturities of these financial instruments.
Recent
Accounting Standards
The
Company has reviewed all other FASB-issued ASU accounting pronouncements and interpretations thereof that have effective dates during
the period reported and in future periods. The Company has carefully considered the new pronouncements that alter previous GAAP and does
not believe that any new or modified principles will have a material impact on the Company’s reported financial position or operations
in the near term. The applicability of any standard is subject to the formal review of the Company’s financial management and certain
standards are under consideration.
3. PROPERTY
AND EQUIPMENT
April 30,
January 31,
2023
2023
Lab equipment
$ 144,585
$ 144,585
Machinery and equipment
1,243,252
1,240,628
Furniture and fixtures
19,643
19,643
1,407,480
1,404,856
Less: Accumulated depreciation
( 554,035 )
( 507,121 )
Net Property and Equipment
$ 853,445
$ 897,735
Depreciation expenses amounted to $ 46,914
and $ 45,021 for the three months ended April 30, 2023, and 2022, respectively. During the three months ended April 30, 2023, and 2022,
depreciation expenses of $ 36,179 and $ 27,693 , respectively, have been allocated to cost of goods sold.
11
4. NOTES
PAYABLE
Notes
Payable
Active
Intelligence, the Company’s newly acquired subsidiary, entered into an agreement with the Carolina Small Business Development Fund
for a line of credit of $160,000 due October 16, 2029, with interest of 5% per year . The amount assumed was $ 139,184 . The loan requires
monthly payments of principal and interest of $ 1,697 . During the three months ended April 30, 2023, the Company made $ 4,877 of principal
payments. As of April 30, 2023, the amount due was $ 96,837 , of which $ 15,535 is current.
On
April 3, 2022, the Company entered into a retail installment agreement for the purchase of an automobile. The contract price was $32,274,
of which $22,795 was financed. The agreement is for five years bearing interest at 2.95% per annum with payments of $495 per month. The
loan is secured by automobile. As of April 30, 2023, the amount due was $18,523 of which $4,396 is current.
Line
of Credit
On
March 19, 2023, the Company entered into a Credit Line Note agreement with TII Jet Services LDA, a shareholder of the Company, for a
credit facility of $ 2 million. Outstanding advances under the Note bears interest at 7 % per annum. The promissory note is due and payable
in full on March 19, 2026. Interest is payable annually on December 31 of each year during the term of the note. In March 2023, the Company
was advanced $ 50,000 on the Note. The Company recorded interest expense of $ 504 for the three months ended April 30, 2023.
Interest expense
for the three months ended April 30, 2023, and 2022, was $ 3,166 and $ 4,110 , respectively.
5. INTANGIBLE ASSETS
As of April
30, 2023, and January 31, 2023, intangible assets consisted of intellectual property and trademarks, customer base, and license agreement,
net of amortization, as follows:
April 30,
January 31,
2023
2023
Customer base
$ 314,100
$ 314,100
Intellectual property and trademarks
817,400
817,400
Total
1,131,500
1,131,500
Less: Accumulated amortization
( 379,357 )
( 351,070 )
Net Intangible Assets
$ 752,143
$ 780,430
Amortization
expense for the three months ended April 30, 2023, and 2022 was $ 28,287 and $ 32,454 , respectively.
Year Ended January 31,
2024
$ 84,822
2025
113,109
2026
113,109
2027
113,109
2028
113,109
2029 and thereafter
214,885
$ 752,143
6. RELATED PARTY TRANSACTIONS
a) On February 1, 2023, options to purchase 30,000 shares of the Company’s common stock were issued
to an executive of the Company at a price of $ 3.975 per share. The options vest immediately and expire in three years . The fair value
of the options issued for services amounted to $ 75,030 and was expensed during the three months ended April 30, 2023.
b) On March 19, 2023, the Company entered into a Credit Line Note agreement with TII Jet Services LDA, a
shareholder of the Company, for a credit facility of $ 2 million. See Note 4 for further information. TII Jet Services LDA is owned 100 %
by a shareholder of the Company.
7. STOCKHOLDERS’ EQUITY
Preferred Stock
On January 15, 2016, the board of directors of the Company
approved a certificate of amendment to the articles of incorporation and changed the authorized capital stock of the Company to include
and authorize 10,000,000 shares of Preferred Stock, par value $ 0.001 per share.
12
On May 24, 2019, the board of directors created a series of
preferred stock consisting of 2,500,000 shares designated as the Series A Convertible Preferred Stock (“Series A Preferred Stock”).
On June 20, 2019, the Series A preferred Stock was terminated, and the 2,500,000 shares were restored to the status of authorized but
unissued shares of Preferred Stock, without designation as to series, until such stock is once more designated as part of a particular
series by the board of directors.
Common Stock
On June 25, 2019, the Company effected a one-for-four reverse
stock split, pursuant to which each share of common stock became converted into 0.25 shares of common stock, and the Company decreased
its authorized common stock from 100,000,000 to 25,000,000 shares.
On January 27, 2020, the Company amended its Articles of Incorporation
to increase its authorized common shares from 25,000,000 authorized shares to 250,000,000 authorized shares.
On July 26, 2022, the Company effected a 7-for-6 forward stock
split pursuant to which each shareholder of record as of the August 12, 2022, record date received one (1) additional share for each six
(6) shares held as of the record date.
On August 4, 2022, the Company amended its Articles of Incorporation
to increase its authorized common shares from 250,000,000 authorized shares to 291,666,666 authorized shares.
Activity during the Three Months Ended April 30, 2023
(a) As of April 30, 2023, the Company holds 10,000 of its shares comprising $ 32,641 of treasury stock. There was no activity during the
three months ended April 30, 2023.
Activity during the Three Months Ended
April 30, 2022
(a) In March 2022, the Company purchased 26,836 shares of its common stock for $ 89,196 and recorded the purchase
as Treasury Stock. As of April 30, 2022, the Company holds 58,547 of its shares comprising the $ 193,633 of treasury stock.
8. OPTIONS and WARRANTS
Warrants
The following table summarizes the changes
in warrants outstanding and the related price of the shares of the Company’s common stock issued to non-employees of the Company
during the three months ended April 30, 2023. On March 7, 2023, the Company issued 30,000 warrants to purchase the Company’s common
shares to Barandic Holdings Ltd. for services provided. The warrants are exercisable at a price of $ 4.00 per share and expire five years
from the date of issuance.
Exercise
Remaining
Intrinsic
Shares
Price
Life
Value
Outstanding, January 31, 2022
1,435,622
$ 6.91
3.93 years
$ -
Granted
25,000
7.50
5.00 years
-
Expired/Cancelled
( 97,534 )
5.36
-
-
Exercised
( 55,417 )
5.36
-
-
Outstanding, January 31, 2023
1,307,671
6.43
3.34 years
-
Granted
30,000
4.00
5.00 years
-
Expired/Cancelled
( 54,633 )
12.00
-
-
Exercised
-
-
-
-
Outstanding- April 30, 2023
1,283,038
$ 6.14
3.27 years
$ -
Exercisable - April 30, 2023
1,283,038
$ 6.14
3.27 years
$ -
13
The following
table summarizes additional information relating to the warrants outstanding as of April 30, 2023:
Weighted Average
Weighted Average
Weighted Average
Range of
Remaining Contractual
Exercise
Price for
Exercise
Price for
Exercise
Prices
Number
Outstanding
Life
(Years)
Shares Outstanding
Number
Exercisable
Shares
Exercisable
Intrinsic
Value
$ 4.00
30,000
4.85
$ 4.00
30,000
$ 4.00
$ -
$ 6.43
1,082,205
3.44
$ 6.43
1,082,205
$ 6.43
$ -
$ 4.20
145,833
1.48
$ 4.20
145,833
$ 4.20
$ -
$ 7.50
25,000
4.53
$ 7.50
25,000
$ 7.50
$ -
Options
The following table summarizes the changes
in options outstanding and the related price of the shares of the Company’s common stock issued to employees of the Company. See
Note 7 for the issuance of related party options.
On November 1, 2021, the Board of Directors
adopted the 2021 Employee Stock Option Plan (the “Plan”). The Company has reserved 408,333 shares to issue and sell upon the
exercise of stock options. In accordance with the Plan, on February 1, 2022, the Company reserved an additional 233,333 shares and on
February 1, 2023, the Company reserved an additional 233,333 shares. The options vest immediately and expire in three years. Under the
Plan, options may be granted which are intended to qualify as Incentive Stock Options (“ISO’s”) under Section 422 of
the Internal Revenue Code of 1986 (the “Code”) or which are not (“non-ISO’s”) intended to qualify as Incentive
Stock Options thereunder. The Plan also provides for restricted stock awards representing shares of common stock that are issued subject
to such restrictions on transfer and other incidents of ownership and such forfeiture conditions as the Board of Directors, or the committee
administering the Plan composed of directors who qualify as “independent” under Nasdaq rules, may determine. On November 3,
2021, the Company filed a Registration Statement on Form S-8, to register under the Securities Act of 1933, as amended the 408,333 shares
of common stock reserved for issuance under the Plan. As of April 30, 2023, 374,664 shares remain in the Plan.
During the three months ended April 30,
2023, 30,000 options to purchase shares of the Company’s common stock were issued to an executive officer at a price of $ 3.975 per
share. The options vest immediately and expire three years from the date of issuance. The fair value of the options issued for services
amounted to $ 75,030 and was recorded during the three months ended April 30, 2023. The Company used the Black-Scholes valuation model
to record the fair value. The valuation model used a dividend rate of 0 %; expected term of 1.5 years; volatility rate of 143.54 %; and
a risk-free rate of 4.5 %.
During the year ended January 31, 2023,
279,584 options to purchase shares of the Company’s common stock were issued to executive officers and directors of the Company
at prices of $ 3.59 to $ 4.50 per share. The options vest immediately and expire three years from the date of issuance. The fair value of
the options issued for services amounted to $ 732,130 and was recorded during the year ended January 31, 2023. The Company used the Black-Scholes
valuation model to record the fair value. The valuation model used a dividend rate of 0 %; expected term of 1.5 years; volatility rate
of 152.10 - 174.45 %; and a risk-free rate of 3 %.
Exercise
Remaining
Intrinsic
Shares
Price
Life
Value
Outstanding, January 31, 2022
190,751
$ 4.26
2.97 years
Granted
279,584
3.93
3.00 years
-
Expired/Cancelled
-
-
-
Exercised
-
-
-
Outstanding, January 31, 2023
470,335
4.13
2.53 years
Granted
30,000
3.98
3.00 years
-
Expired/Cancelled
-
-
-
Exercised
-
-
-
Outstanding- April 30, 2023
500,335
$ 4.12
2.31 years
$ -
Exercisable - April 30, 2023
500,335
$ 4.12
2.31 years
$ -
14
The
following table summarizes additional information relating to the options outstanding as of April 30, 2023:
Weighted Average
Weighted Average
Weighted Average
Range of
Remaining Contractual
Exercise
Price for
Exercise
Price for
Exercise
Prices
Number
Outstanding
Life
(Years)
Shares
Outstanding
Number
Exercisable
Shares
Exercisable
Intrinsic
Value
$ 4.58
46,666
1.73
$ 4.58
46,666
$ 4.58
$ -
$ 4.16
144,085
1.73
$ 4.16
144,085
$ 4.16
$ -
$ 4.50
58,334
2.26
$ 4.50
58,334
$ 4.50
$ -
$ 4.09
78,750
2.26
$ 4.09
78,750
$ 4.09
$ -
$ 3.59
35,000
4.42
$ 3.59
35,000
$ 3.59
$ -
$ 3.75
57,500
2.61
$ 3.75
57,500
$ 3.75
$ -
$ 4.12
50,000
2.61
$ 4.12
50,000
$ 4.12
$ -
$ 3.98
30,000
2.76
$ 3.98
30,000
$ 3.98
$ -
9. SEGMENT
REPORTING
We organize and manage our business
in the following two segments which meet the definition of reportable segments under ASC280-10, Segment Reporting: Sales of Goods and
Services. These segments are based on the customer type of products or services provided and are the same as our business units. Separate
financial information is available and regularly reviewed by our chief decision maker, who is our chief executive officer, in making resource
allocation decisions for our segments. Our chief-decision maker evaluates segment performance to the GAAP measure of gross profit.
Three Months Ended
April 30,
2023
2022
Net sales
Pocono Pharmaceuticals
$
401,057
$
401,990
4P Therapeutics
75,875
75,932
476,932
477,922
Gross profit
Pocono Pharmaceuticals
169,308
198,059
4P Therapeutics
52,976
2,427
222,284
200,486
Operating expenses
Selling ,general and administrative
Pocono Pharmaceuticals
136,863
142,036
4P Therapeutics
16,921
24,389
Corporate
685,948
602,126
Research and development - 4P Therapeutics
400,430
117,184
1,240,162
885,735
Depreciation and Amortization
Pocono Pharmaceuticals
$
55,208
$
55,458
Corporate
$
3,497
$
5,521
4P Therapeutics
16,496
16,496
$
75,201
$
77,475
15
The
following table presents information about net sales and property and equipment, net of accumulated depreciation, in the United States
and elsewhere.
Three Months
Ended
April
30,
2023
2022
Net sales:
United
States
$ 476,932
$ 477,922
Outside
the United States
-
-
$ 476,932
$ 477,922
April 30,
January 31,
2023
2023
Property and equipment, net
of accumulated depreciation
United
States
$ 853,445
$ -
Outside
of the United States
-
-
$ 853,445
$ -
Assets:
Corporate
$ 1,035,136
$ 1,745,731
Pocono
Pharmaceuticals
2,317,645
5,400,814
4P
Therapeutics
5,350,420
2,309,832
$ 8,703,201
$ 9,456,377
10. COMMITMENTS AND CONTIGENCIES
Employment Agreements
The Company entered into a three-year
employment agreement with Gareth Sheridan, our CEO, and Serguei Melnik, our President, effective February 1, 2022 . The agreement also
provides that the executives will continue as a director. The agreement provides for an initial term, commencing on the effective date
of the agreement and ending on January 31, 2025 , and continuing on a year-to-year basis thereafter unless terminated by either party on
not less than 30 days’ notice given prior to the expiration of the initial term or any one-year extension. For their services to
the Company during the term of the agreement, Mr. Sheridan and Mr. Melnik will receive an annual salary of $ 250,000 per annum, commencing
on the effective date of the agreement. Mr. Sheridan and Mr. Melnik will also receive a performance bonus of 3.5 % of net income before
income taxes. As of July 31, 2022, the Company and Mr. Sheridan and Mr. Melnik mutually agreed to reduce their annual salary to $ 150,000 .
The Company entered into a three-year
employment agreement with Gerald Goodman, our CFO, effective February 1, 2022. The agreement provides for an initial term, commencing
on the effective date of the agreement and ending on January 31, 2025, and continuing on a year-to-year basis thereafter unless terminated
by either party on not less than 30 days’ notice given prior to the expiration of the initial term or any one-year extension. For
his services to the Company during the term of the agreement, Mr. Goodman will receive an annual salary of $ 210,000 per annum, commencing
on the effective date of the agreement. As of July 31, 2022, the Company and Mr. Goodman mutually agreed to reduce his annual salary to
$ 110,000 .
Kindeva Drug Delivery Agreement
On January 4, 2022, the Company signed
a feasibility agreement with Kindeva Drug Delivery, L.P. (“Kindeva”) to develop Nutriband’s lead product, AVERSAL Fentanyl,
based on its proprietary AVERSAL abuse deterrent transdermal technology and Kindeva’s FDA-approved transdermal fentanyl patch (fentanyl
transdermal system). The feasibility agreement provides for on adapting Kindeva’s commercial transdermal manufacturing process to
incorporate AVERSAI technology in the fentanyl transdermal system.
16
The agreement will remain in force until
the earlier of: (1) the completion of the work and deliverables under the Workplan; or (2) two (2) years after the Effective Date, after
which time the agreement will expire.
The estimated cost to complete the feasibility
Workplan is approximately $ 2.1 million and the timing to complete will be between eight to fifteen months. Nutriband made an advance deposit
of $ 250,000 in January 2022, to be applied against the final invoice. The Workplan commenced in February 2022, and the parties believe
the Workplan will be completed in the time estimated in the agreement. During the three months ended April 30, 2023, the Company has incurred
expenses of $ 400,430 and the deposit of $ 250,000 is included in prepaid expenses.
Lease Agreement
On February 1, 2022, Pocono Pharmaceuticals
entered into a lease agreement with Geometric Group, LLC for 12,000 square feet of warehouse space currently occupied by Active Intelligence.
The monthly rental is $ 3,000 and the lease expires on January 31, 2025 . The lease can be extended for an additional three years at the
same monthly rental. The Company recorded a Right of Use asset in the amount of $ 94,134 in connection with the valuation.
MDM Worldwide Agreement
In September 2022, the Company entered
into a public relations agreement with MDM Worldwide. In connection with the agreement, the Company agreed to issue 20,000 options to
MDM Worldwide. The terms of the options have not yet been agreed and the Company will issue the options when the exercise price and term
are finalized.
Money Channel Agreement
On March 13, 2023, the Company entered
into a media advertising agreement with Money Channel Inc. The Company will pay a monthly fee and after ninety days can cancel the agreement.
The Company, after 90 days, will also issue options to purchase 50,000 shares of common stock to Money Channel Inc. at an exercise price
of $ 4.00 per share.
11. SUBSEQUENT EVENTS
The Company has evaluated subsequent events through the filing of this
Quarterly Report on Form 10-Q and determined there have been no events that have occurred that would require adjustments to our disclosures
in the consolidated financial statements.
17
ITEM 2. MANAGEMENT’S DISCUSSION
AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
FORWARD LOOKING STATEMENTS
This report contains forward-looking statements
regarding our business, financial condition, results of operations and prospects. Words such as “expects,” “anticipates,”
“intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions
or variations of such words are intended to identify forward-looking statements but are not deemed to represent an all-inclusive means
of identifying forward-looking statements as denoted in this report. Additionally, statements concerning future matters are forward-looking
statements.
Although forward-looking statements in this report
reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently,
forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from
the results and outcomes discussed in or anticipated by the forward-looking statements. Factors that could cause or contribute to such
differences in results and outcomes include, without limitation, those specifically addressed under the headings “Management’s
Discussion and Analysis of Financial Condition and Results of Operations” in our annual report on Form 10-K for the year ended January
31, 2023, in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Form 10-Q
and information contained in other reports that we file with the SEC. You are urged not to place undue reliance on these forward-looking
statements, which speak only as of the date of this report.
We undertake no obligation to revise or update
any forward-looking statements to reflect any event or circumstance that may arise after the date of this report, except as required by
law. Readers are urged to carefully review and consider the various disclosures made throughout the entirety of this quarterly report,
which are designed to advise interested parties of the risks and factors that may affect our business, financial condition, results of
operations and prospects.
It should be noted that current public health
threats could adversely affect our ongoing or planned business operations. In particular, the novel coronavirus (COVID-19) has resulted
in quarantines, restrictions on travel and other business and economic disruptions. We cannot presently predict the scope and severity
of any potential business shutdowns or disruptions, but if we or any of the third parties with whom we engage, including the partners
and other third parties with whom we conduct business, were to experience shutdowns or other business disruptions, our ability to conduct
our business in the manner and on the timelines presently planned could be materially and adversely impacted. The measures being taken
by service providers and government agencies to suppress the spread of COVID-19 infection may delay time to production of our planned
abuse deterrent fentanyl transdermal system product and therefor delay the time of filing with FDA for approval.
Overview
AVERSA™ transdermal abuse deterrent technology.
Our primary business is the development of a portfolio of transdermal
pharmaceutical products. Our lead product is our abuse deterrent fentanyl transdermal system which will require approval from the Food
and Drug Administration (“FDA”) and substantial additional capital for research and development. Our abuse deterrent transdermal
product under development has the potential to provide clinicians and patients with an extended-release transdermal fentanyl product for
use in managing chronic pain requiring around the clock opioid therapy combined with properties designed to deter the abuse and misuse
of fentanyl patches. In addition, we believe that our abuse deterrent technology can be broadly applied to various transdermal products
and our strategy is to follow the development of our abuse deterrent fentanyl transdermal system with the development of abuse deterrent
transdermal products for pharmaceuticals that have risks or a history of abuse. We received on January 28, 2022 an Issue Notification
from the United States Patent and Trademark Office (USPTO) for our United States patent entitled, “Abuse and Misuse Deterrent Transdermal
System,” that protects our Aversa™ technology platform.
Transdermal Pharmaceutical Products
Through October 31, 2018, our business was the development of a line
of consumer and health products that are delivered through a transdermal or topical patch. Following our acquisition of 4P Therapeutics
on August 1, 2018, our focus expanded to include prescription pharmaceuticals, and we are seeking to develop and seek FDA approval on
a number of transdermal pharmaceutical products under development by 4P Therapeutics.
Most of our planned consumer products require FDA approval for sale
in the United States, and we have not sought to obtain, and we do not plan to seek to obtain, FDA approval to market these products in
the United States at this time. Following our acquisition of selected assets from Pocono Coated Products, LLC (“Pocono”),
we are primarily focused on providing contract manufacturing services and consulting services to 3 rd party brands with no intention
at this time to launch our own consumer products.
4P Therapeutics has not generated any revenue from any of its products
under development. Rather, prior to our acquisition, 4P Therapeutics generated revenue to provide cash for its operations through contract
research and development and related services for a small number of clients in the life sciences field on an as-needed basis. We are,
for the near term, continuing this activity, although we do not anticipate that it will generate significant revenues and, since our acquisition,
it has generated minor gross margins. We have no long-term contractual obligations, and either party can terminate at any time.
18
With the change in our focus, our capital requirements have increased
substantially. The process of developing pharmaceutical products and submitting them for FDA approval is both time consuming and expensive,
with no assurance of obtaining approval from the FDA to market our product in the United States. We will require approximately $13 million
for research and development of our abuse deterrent fentanyl transdermal system, including clinical manufacturing and clinical trials
that need to be completed in order to obtain FDA approval. However, the total cost could be substantially in excess of that amount.
On August 31, 2020, the Company entered into a Purchase Agreement (“Agreement”),
with Pocono Coated Products (“PCP”), pursuant to which PCP agreed to sell the Company all of the assets associated with its
Transdermal, Topical, Cosmetic and Nutraceutical business (the “Assets”). PCP is the manufacturer of our transdermal consumer
products, and we bought that business from them. The purchase price for the Assets was (i) $6,000,000 paid in shares of the Company’s
common stock at a value of the average price of the previous 90 days at the date of Closing (the “Shares”); (ii) a promissory
note of the Company in the principal amount of $1,500,000, which is due upon the earlier of (a) twelve (12) months from issuance, or (b)
immediately following a capital raise of no less than $4,000,000 and/or a public offering of no less than $4,000,000. The note was repaid
in full in October 2021. Subsequent to the repayment of the note, the Shares were released from escrow.
On October 5, 2021, the Company, having been approved for the listing
of its common stock on The Nasdaq Capital Market effective October 1, 2021, consummated a public offering (the “IPO”) of units
(the “Units”), of common stock and warrants that were offered in the IPO on The Nasdaq Capital Market, which included 1,231,200
(each a “Unit”), each Unit consisting of one share of common stock, par value $0.001 per share, and one warrant (each a “Warrant”)
at a price of $5.36 per Unit. Each Warrant is immediately exercisable, will entitle the holder to purchase one share of common stock at
an exercise price of $6.43 and will expire five (5) years from the date of issuance. The underwriters’ over-allotment option was
exercised for 184,800 warrants to purchase shares of common stock bringing to total net proceeds to the Company from the IPO to $5,836,230.
The shares of common stock and Warrants are separately transferred immediately upon issuance. As of April 30, 2023, 457,795 Warrants issued
in the IPO have been exercised, with net proceeds to the Company of $2,942,970.
On November 1, 2021, The Board of Directors adopted the 2021 Employee
Stock Option Plan (the “Plan”). The Company has reserved 408,333 shares to issue and sell upon the exercise of stock options
issued under the Plan. On November 3, 2021, the Company filed a Registration Statement on Form S-8, to register under the Securities Act
of 1933, as amended, the 408,333 shares of common stock reserved for issuance under the Plan, and on October 12, 2022, a Post-Effective
Amendment to the Form S-8 was filed with the SEC. In accordance with the Plan, on February 1, 2022, the Company reserved an additional
233,333 shares and on February 1, 2023, the Company reserved an additional 233,333 shares. On January 21, 2022, the Board approved options
to purchase 190,751 shares of the Company’s common stock under the Plan issued to executive officers and directors of the Company
at an exercise price of $4.16 ($4.58 per share for two of the officers as required by IRS rules). On August 1, 2022, the Board approved
option grants previously approved by the Compensation Committee for an aggregate of 137,084 shares of common stock at exercise prices
$4.09 or $4.50 per share depending on IRS rules as applicable to the recipient, on September 30, 2022, approved option issuances under
the Plan for an aggregate of 35,000 shares of common stock at an exercise price of $3.59 per share for services provided by the independent
directors, as previously approved by the Compensation Committee. On December 7, 2022, the Board approved option grants to executive officers
previously approved by the Compensation Committee for an aggregate of 107,500 shares at exercise prices of $3.75 ($4.12 for two of the
officers as required by IRS rules). On February 1, 2023, the Board approved an option grant to purchase 30,000 shares of common stock
at an exercise price of $3.975 per share previously approved by the Compensation Committee to an executive officer for services. As of
April 30, 2023, 374,664 shares remain in the Plan.
The Company received a favorable verdict on July 13, 2022 from
the Circuit Court, Orange County, Florida, providing for rescission of the Company’s 2017 acquisition of Advanced Health Brands
and recovery by the Company of the 1,400,000 shares (adjusted for a 1-for-4 reverse stock split effective June 23, 2019 and the 7-for-six
forward stock split effective August 15, 2022) of common stock issued in the acquisition, effectively allowing the Company on July 25,
2022 to cancel 1.4M shares of common stock held by the defendants.
On October 31, 2022, the Company filed the Proxy Statement with the
SEC for its Annual Meeting of Stockholders, for the election of directors held on December 9, 2022, in Orlando, Florida. This Proxy Statement
is available on our website at HTTPS://Nutriband.com/proxy .
Forward Split of our Common Stock.
On July 26, 2022, our Board of Directors approved the amendment to
our Articles of Incorporation to effect a 7 for 6 forward stock split (the “Stock Split”) of our outstanding common stock.
We filed the amendment set forth in a Certificate of Change with the Secretary of State of Nevada on August 4, 2022. The 7:6 forward split
was effective for trading purposes on the Nasdaq Capital Market on August 12, 2022. Each shareholder of record as of the August 15, 2022
record date received one (1) additional share of common stock for each six (6) shares held as of the record date. No fractional shares
of common stock were issued in connection with the Stock Split. Instead, all shares were rounded up to the next whole share. In connection
with the Stock Split, which did not require shareholder approval under the Nevada corporation law, the number of authorized shares of
common stock of the Company was increased in the same ratio as the shares of outstanding common stock were increased in the Stock Split,
from 250,000,000 authorized shares to 291,666,666 authorized shares.
19
Results of Operations
Three Months Ended April 30, 2023 and 2022
For the three months ended April 30, 2023, we
generated revenue of $476,932 and our costs of revenue were $254,648 resulting in a gross margin of $222,284. For the three months ended
April 30, 2022, we generated revenue of $477,922 and our costs of revenue were $277,436, resulting in a gross margin of $200,486. Our
revenue for April 30, 2023, was derived from sales of $401,057 from our Transdermal Patches segment and $75,875 from contract services
from our 4P Therapeutics segment. The revenue from the Transdermal Patches segment remained relatively constant from the prior year. An
increase in demand continued in the subsequent quarter. Our cost of revenue for our contract research and development services represents
our labor cost plus a modest amount of material costs which we passed on to the client. Our cost of sales decreased during the period
for our contract services in comparison to the prior year as our main contract has been completed and the balance of the contract is being
recognized with limited additional costs.
For the three months ended April 30, 2023, our
selling, general and administrative expenses were $839,732 primarily legal, accounting and administrative salaries compared to $768,551
for the three months ended April 30, 2022.The increase from 2022 is primarily attributable to non-cash equity-based expenses of approximately
of $162,000.
During the three months ended April 30, 2023, the Company incurred
research and development expenses of its Aversa Fentanyl product of $ 400,430, primarily of salaries and increases in development costs
from Kindeva as compared to $117,184 for the three months ended April 30, 2022.
We incurred interest expense of $3,166 for the
three months ended April 3, 2023, as compared to $4,110 for the three months ended April 30, 2022.
As a result of the foregoing, we sustained a net
loss of $1,015,229 or $(0.13) per share (basic and diluted) for the three months ended April 30, 2023, compared with a loss of $689,989,
or $(0.08) per share (basic and diluted) for the three months ended April 30, 2022.
Liquidity and Capital Resources
As of April 30, 2023, we had $1,278,075 in cash
and cash equivalents and working capital of $1,209,099, as compared with cash and cash equivalents of $1,985,440 and working capital of
$1,945,132 as of January 31, 2023. During the three months ended April 30, 2023, the Company entered into a three year Credit Line Note
facility for $2 million, to fund its research and development of its Aversa Fentanyl product.
For the three months ended April 30, 2023, we
used cash of $749,864 in our operations. The principal adjustments to our net loss of $1,105,229 were depreciation and amortization of
$75,201, and the issuance of employee stock options and warrants for services in the amount of $162,120.
For the three months ended April 30, 2023, we
used cash in investing activities of $2,624 primarily for the purchase of equipment.
For the three months ended April 30, 2023, we
provided cash in financing activities of $45,123 primarily from the proceeds of $50,000 from its line of credit, offset from the payment
on notes of $4,877.
Off Balance Sheet Arrangements
We have no off-balance sheet arrangements that
have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition,
revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
Critical Accounting Policies
Going Concern Assessment
Management assesses liquidity and going concern uncertainty in the
Company’s condensed financial statements to determine whether there is sufficient cash on hand and working capital, including available
borrowings on loans, to operate for a period of at least one year from the date the consolidated financial statements are issued or available
to be issued, which is referred to as the “look-forward period”, as defined in GAAP. As part of this assessment, based on
conditions that are known and reasonably knowable to management, management will consider various scenarios, forecasts, projections, estimates
and will make certain key assumptions, including timing and nature of projected cash expenditures or programs, its ability to delay or
curtail expenditures or programs and its ability to raise additional capital, if necessary, among other factors. Based on this assessment,
as necessary or applicable, management makes certain assumptions around implementing curtailments or delays in the nature and timing of
programs and expenditures to the extent it deems probable those implementations can be achieved and management has the proper authority
to execute them within the look-forward period.
20
As of April 30, 2023, the Company had cash and cash equivalents of
$1,278,075 and working capital of $1,209,099. For the three months ended April 30, 2023, the Company incurred an operating loss of $1,015,229
and used cash flow from operations of $749,864. The Company has generated operating losses since its inception and has relied on sales
of securities and issuance of third-party and related-party debt to support cash flow from operations. In October 2021, the Company consummated
a public offering and received net proceeds of $5,836,230. The Company also received to date $3,239,845 proceeds from the exercise of
warrants. The Company has used these proceeds to fund operations and will continue to use the funds as needed. In March 2023, the Company
entered into a three-year $2,000,000 Credit Line Note facility which will permit the Company to draw down on the credit line to fund the
Company’s research and development of its Aversa product.
Management has prepared estimates of operations for the next twelve
months and believes that sufficient funds will be generated from operations to fund its operations for one year from the date of the filing
of these condensed consolidated financial statements, which indicates improved operations and the Company’s ability to continue
operations as a going concern. The impact of COVID-19 on the Company’s business has been considered in these assumptions; however,
it is too early to know the full impact of COVID-19 or its timing on a return to normal operations.
Management believes the substantial doubt
about the ability of the Company to continue as a going concern is alleviated by the above assessment. however, it is too early to
know the full impact of COVID-19 or its timing on a return to normal operations.
Use of Estimates
The preparation of the consolidated financial statements in conformity
with accounting principles generally accepted in the United States of America requires the Company to make estimates and assumptions that
affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities.
On an ongoing basis, the Company evaluates its estimates including, but not limited to, those related to such items as income tax exposures,
accruals, depreciable/useful lives, allowance for doubtful accounts and valuation allowances. The Company bases its estimates on historical
experience and on other various assumptions that are believed to be reasonable under the circumstances, the results of which form the
basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual
results could differ from those estimates.
Revenue Recognition
In May 2014, the FASB issued ASU No. 2014-09, “Revenue from Contracts
with Customers (Topic 606) (“ASU 2014-09”), which amends the accounting standards for revenue recognition. ASU 2014-09 is
based on principles that govern the recognition of revenue at an amount an entity expects to be entitled when products are transferred
to a customer. The Company recognizes revenue based on the five criteria for revenue recognition established under Topic 606: 1) identify
the contract, 2) identify separate performance obligations, 3) determine the transaction price, 4) allocate the transaction price among
the performance obligations, and 5) recognize revenue as the performance obligations are satisfied.
Accounts Receivable
Trade accounts receivables are recorded at the net invoice value and
are not interest bearing. The Company maintains allowances for doubtful accounts for estimated losses from the inability of its customers
to make required payments. The Company determines its allowances by both specific identification of customer accounts where appropriate
and the application of historical loss to non-applicable accounts. For the years ended January 31, 2023 and 2022, the Company recorded
no bad debt expense for doubtful accounts related to account receivable.
Inventories
Inventories are valued at the lower of cost and
reasonable value determined using the first-in, first-out (FIFO) method. Net realized value is the estimated selling price in the ordinary
course of business, less applicable variable selling expenses. The cost of finished goods and work in process is comprised of material
costs, direct labor costs and other direct costs and related production overheads (based on normal operating capacity). As of April 30,
2023, total inventory was $181,497, consisting of work-in-process of $41,432 and raw materials of $140,064. As of January 31, 2023, total
inventory was $229,335, consisting of work-in-process of $11,021 and raw materials of $218,334.
Intangible Assets
Intangible assets include trademarks, intellectual property and customer
base acquired through business combinations. The Company accounts for Other Intangible Assets under the guidance of ASC 350, “Intangibles-Goodwill
and Other.” The Company capitalizes certain costs related to patent technology. A substantial component of the purchase price related
to the Company’s acquisitions have also been assigned to intellectual property and other intangibles. Under the guidance, other
intangible assets with definite lives are amortized over their estimated useful lives. Intangible assets with indefinite lives are tested
annually for impairment. Trademarks, intellectual property and customer base are being amortized over their estimated useful lives of
ten years.
21
Goodwill
Goodwill represents the difference between the total purchase price
and the fair value of assets (tangible and intangible) and liabilities at the date of acquisition. Goodwill is reviewed for impairment
annually on January 31, and more frequently as circumstances warrant, and written down only in the period in which the recorded value
of such assets exceeds their fair value. The Company does not amortize goodwill in accordance with ASC 350. In connection with the Company’s
acquisition of 4P Therapeutics LLC in 2018, the Company recorded Goodwill of $1,719,235. On August 31, 2020, in connection with the Company’s
acquisition of Pocono Coated Products LLC and Active Intelligence LLC, the Company recorded Goodwill of $5,810,640. During the years ended
January 31, 2023 and 2022, the Company recorded an impairment charge of $327,326 and $2,180,836, respectively, reducing the Active Intelligence
LLC Goodwill to $3,302,478. As of April 30, 2023 and January 31 2023, Goodwill amounted to $5,021,713 and $5,021,713, respectively.
Long-lived Assets
Management reviews long-lived assets for potential impairment whenever
significant events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment exists
when the carrying amount of the long-lived asset is not recoverable and exceeds its fair value. The carrying amount of a long-lived asset
is not recoverable if it exceeds the sum of the estimated undiscounted cash flows expected to result from the use and eventual disposition
of the asset. If an impairment exists, the resulting write-down would be the difference between the fair market value of the long-lived
asset and the related book value.
Earnings per Share
Basic earnings per share of common stock is computed by dividing net
earnings by the weighted average number of shares of common stock outstanding during the period. Diluted earnings per share
is computed by dividing net earnings by the weighted average number of shares of common stock and potential shares of common stock outstanding
during the period. Potential shares of common stock consist of shares issuable upon the exercise of outstanding options and common
stock purchase warrants. As of April 30, 2023, and 2022, there were 1,783,373 and 1,626,373 common stock equivalents outstanding, that
were not included in the calculation of dilutive earnings per share as their effect would be anti-dilutive.
Stock-Based Compensation
ASC 718, “Compensation - Stock Compensation,” prescribes
accounting and reporting standards for all share-based payment transactions in which employee services, and, since February 1, 2019, non-employees,
are acquired. Transactions include incurring liabilities, or issuing or offering to issue shares, options and other equity instruments
such as employee stock ownership plans and stock appreciation rights. Share-based payments to employees, including grants of employee
stock options, are recognized as compensation expense in the financial statements based on their fair values. That expense is recognized
over the period during which an employee is required to provide services in exchange for the award, known as the requisite service period
(usually the vesting period). As of February 1, 2019, pursuant to ASC 2018-07, ASC 718 was applied to stock-based compensation for both
employees and non-employees.
Research and Development Expenses
Research and development costs are expensed as incurred.
Income Taxes
Taxes are calculated in accordance with taxation principles currently
effective in the United States and Ireland.
The Company accounts for income taxes under the asset and liability
method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that
have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined based
on the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the
year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities
is recognized in income in the period that includes the enactment date.
The Company records net deferred tax assets to the extent they believe
these assets will more-likely-than-not be realized. In making such determination, the Company considers all available positive
and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax planning
strategies and recent financial operations. In the event the Company was to determine that it would be able to realize its
deferred income tax assets in the future in excess of its net recorded amount, the Company would make an adjustment to the valuation allowance
which would reduce the provision for income taxes.
22
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES
ABOUT MARKET RISK.
Not applicable.
ITEM 4. CONTROLS AND PROCEDURES
Disclosure controls and procedures.
As of the end of period covered by this report,
we carried out an evaluation, with the participation of our chief executive officer and chief financial officer, of the effectiveness
of our disclosure controls and procedures pursuant to Securities Exchange Act Rule 13a-15. Based upon that evaluation, we concluded that
our disclosure controls and procedures are not effective in ensuring that information required to be disclosed by us in the reports that
we file or submit under the Securities Exchange Act is recorded, processed, summarized and reported, within the time periods specified
in the SEC’s rules and forms.
Management has determined that our internal controls
contain material weaknesses due to the absence of segregation of duties, as well as lack of qualified accounting personnel, and excessive
reliance on third-party consultants for accounting, financial reporting and related activities. During the past fiscal year, we have added
qualified accounting personnel, so the Company does not have to rely on third-party consultants. The Company has established additional
monitoring controls over the financial statements. We have also improved our internal controls to provide for a detailed accounting review
of all revenue items and accounts receivable and accounts payable transactions in connection with the entry and categorization of each
transaction in the preparation of the Company’s financial statements.
Because of its inherent limitations, internal
control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods
are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the
policies and procedures may deteriorate.
Changes in internal controls over financial reporting.
No changes were made to our internal controls
in the quarterly period covered by this report that have materially affected, or are reasonably likely materially to affect, our internal
control over financial reporting.
23
PART II. OTHER
INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 1A. RISK FACTORS
You should carefully consider the key risks
described below together with all of the other information included in this report and our Annual Report on Form 10-K, filed with the
Securities and Exchange Commission on April 26, 2023, before making an investment decision with regard to our securities. The risks set
forth below and in our Form 10-K are not the only risks facing us. Additional risks and uncertainties may exist that could also adversely
affect our business, prospects or operations. If any of the following risks actually occurs, our business, financial condition or results
of operations could be harmed. In that case, the trading price of our common stock could decline, and you may lose all or a significant
part of your investment.
Because we are an early-stage company with
minimal revenue and a history of losses and we expect to continue to incur losses for the foreseeable future, we cannot assure you that
we can or will be able to operate profitably.
We did not generate any revenue prior to the quarter
ended October 31, 2018 and, since then, we have reported only modest revenue from our pharmaceutical transdermal patch business. We are
subject to the risks common to start-up, pre-revenue enterprises, including, among other factors, undercapitalization, cash shortages,
limitations with respect to personnel, financial and other resources and lack of revenues. Drug development companies typically incur
substantial losses during the product development and FDA testing phase of the business and do not generate revenues until after the drug
has received FDA approval, which cannot be assured, and until the company has started to sell the product. We can give no assurance that
we can or will ever be successful in achieving profitability and the likelihood of our success must be considered in light of our early
stage of operations. We cannot assure you that we will be able to operate profitably or generate positive cash flow. If we cannot achieve
profitability, we may be forced to cease operations and you may suffer a total loss of your investment.
Because we do not have a product we can
market in the United States, we cannot predict when or whether we will operate profitably.
We have not completed the development of our lead
product, which is our abuse deterrent fentanyl transdermal system, and we do not have any product that we can market in the United States.
Because of the numerous risks and uncertainties associated with product development, we cannot assure you that we will be able to develop
and market any products or achieve or attain profitability. If we are able to obtain financing for our operations, we expect that we will
incur substantial expenses as we continue with our product development and clinical trials. Further, if we are required by applicable
regulatory authorities, including the FDA as well as the comparable regulatory agencies in other countries in which we may seek to market
product, to perform studies in addition to those we currently anticipate, our expenses will increase beyond expectations and the timing
of any potential product approval may be delayed. As a result, we expect to continue to incur substantial losses and negative cash flow
for the foreseeable future.
A number of factors, including, but not limited
to the following, may affect our ability to develop our business and operate profitably:
●
our ability to obtain necessary funding to develop our proposed products;
●
the success of clinical trials for our products;
24
●
our ability to obtain FDA approval for us to market any proposed product in our pipeline in the United States;
●
any delays in regulatory review and approval of product in development;
●
if we obtain FDA approval to market our product, our ability to establish manufacturing and distribution operations or entering into manufacturing and distribution agreements with qualified third parties;
●
market acceptance of our products;
●
our ability to establish an effective sales and marketing infrastructure;
●
our ability to protect our intellectual property;
●
competition from existing products or new products that may emerge;
●
the ability to commercialize our products;
●
potential product liability claims and adverse events;
●
our ability to adequately support future growth; and
●
our ability to attract and retain key personnel to manage our business effectively.
Our business is impacted by the following additional
key risks :
●
Our business could be adversely affected by the effects of health pandemics or epidemics, including the recent outbreak of COVID-19, which was declared by the World Health Organization as a global pandemic, and is resulting in travel and other restrictions to reduce the spread of the disease, including state and local orders across the country, which, among other things, direct individuals to shelter at their places of residence, direct businesses and governmental agencies to cease non-essential operations at physical locations, prohibit certain non-essential gatherings, and order cessation of non-essential travel. The effects of these orders, government-imposed quarantines and measures we would take, such as work-from-home policies, may negatively impact productivity, disrupt our business and could delay our clinical programs and timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition. Further, quarantines, shelter-in-place and similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could occur, related to COVID-19 or other infectious diseases could impact personnel at third-party manufacturing facilities in the United States and other countries, or the availability or cost of materials, which could disrupt our supply chain.
●
The FDA regulatory process may take longer and be more expensive than we anticipate without any assurance that we will obtain FDA approval.
●
If we are not able to obtain FDA approval for our lead product, we may not have the resources to develop any other product, and we may not be able to continue in business.
●
We may not be able to launch any products for which we receive FDA marketing approval.
●
We may not be able to establish a distribution network for the marketing and sale of any products for which we receive FDA approval.
●
We may not be able to establish manufacturing facilities in compliance with FDA good manufacturing practices or to enter into manufacturing agreements for the manufacture of our products in an FDA approved manufacturing facility.
●
It may be necessary to us to enter into a joint venture or other strategic relationship in order to develop, perform clinical testing for, manufacture or market any of our proposed products. We may not be able to enter into such a relationship, and any relationship may not be successful, and the other party may have business interests and priorities that are different from ours.
●
We are party to a settlement agreement with the SEC resulting from statements in our SEC filings that did not accurately reflect the FDA’s jurisdiction over our consumer products and did not disclose that we could not legally market these products in the United States. The settlement included a cease-and-desist order against violating the provisions of the Securities Exchange Act which require us to file accurate registration statements and annual reports with the SEC. Our failure to comply with our obligations under the settlement agreement could result in enforcement proceedings against us or our officers.
25
●
We may not be able to protect our rights in our intellectual property, and we may be subject to intellectual property litigation which would be expensive and disruptive of our operations even if we eventually prevail on the merits.
●
Unanticipated side effects or other adverse events resulting from the use of our product could require a recall of our products and, even if no recall is required, our reputation could be impaired by side effects.
●
We may not be able to evaluate potential acquisition candidates, with the result that we may not be able to benefit from the acquisition or integrate the acquired business with our business. We have recently incurred an impairment charge as a result of an acquisition when the intellectual property assets of the acquired company were not as represented. We cannot assure you that we will not incur similar or other problems with any future acquisitions.
●
We may fail to comply with all applicable laws and regulations relating to our product. We may have to change or adapt our operations in the event of changes in national, regional and local government regulations, taxation, controls and political and economic developments that affect our products and the market for our products;
●
We may be unable to accurately estimate anticipated expenses, capital requirements and needs for additional financing;
ITEM 6. EXHIBITS.
Exhibit
Number
Description of Exhibits
31.1
Section 302 Certificate of Chief Executive Officer.
31.2
Section 302 Certification of Chief Financial Officer
32.1
Section 906 Certificate of Chief Executive Officer and Principal Financial Officer.
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
26
SIGNATURES
In accordance with the requirements of the Exchange
Act, the Company has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
NUTRIBAND INC.
June 9, 2023
By:
/s/ Gareth Sheridan
Gareth Sheridan,
Chief Executive Officer
(Principal Executive Officer)
June 9, 2023
By:
/s/ Gerald Goodman
Gerald Goodman,
Chief Financial Officer
(Principal Financial and Accounting Officer)
27
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