Item 8. Financial Statements and Supplementary Data
Item
8. Financial Statements and Supplementary Data.
Our financial statements are stated in thousands United States dollars
and are prepared in accordance with U.S. GAAP.
The
following audited consolidated financial statements are filed as part of this Annual Report:
Reports of Independent Registered Public Accounting Firm, dated September 13, 2021
F-2
- F-3
Consolidated Balance Sheets
F-4
- F-5
Consolidated Statements of Operations
F-6
Consolidated
Statements of Comprehensive Loss
Statements of Changes in Equity
F-7
- F-8
Consolidated Statements of Cash Flows
F-9
Notes to the Consolidated Financial Statements
F-10
- F-31
40
PLURISTEM THERAPEUTICS
INC. AND ITS SUBSIDIARIES
CONSOLIDATED FINANCIAL
STATEMENTS
As
of June 30, 2021
PLURISTEM THERAPEUTICS
INC. AND ITS SUBSIDIARIES
CONSOLIDATED FINANCIAL STATEMENTS
As of June 30, 2021
U.S. DOLLARS IN THOUSANDS
INDEX
Page
Reports of Independent Registered Public Accounting Firm
F-2 - F-3
Consolidated Balance Sheets
F-4 - F-5
Consolidated Statements of Operations
F-6
Statements of Changes in Shareholders’ Equity
F-7 - F-8
Consolidated Statements of Cash Flows
F-9
Notes to Consolidated Financial Statements
F-10 - F-31
F- 1
Report of Independent Registered
Public Accounting Firm
To the board of directors and shareholders of Pluristem Therapeutics
Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheet of Pluristem Therapeutics Inc. and its subsidiaries (the “Company”) as of June 30, 2021, and the related consolidated
statements of operations, of changes in shareholders’ equity and of cash flows for the year then ended, including the related notes (collectively
referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly,
in all material respects, the financial position of the Company at June 30, 2021, and the results of its operations and its cash flows
for the year then ended, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of
the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based
on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and
are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules
and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit of these consolidated financial statements
in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance
about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is
not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit
we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures
to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing
procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures
in the consolidated financial statements. Our audit also included evaluating the accounting principles used and significant estimates
made by management, as well as evaluating the overall presentation of the consolidated
financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current period
audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that
(i) relate to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging,
subjective, or complex judgments. We determined there are no critical audit matters.
/s/ Kesselman & Kesselman
Certified Public Accountants (lsr.)
A member firm of PricewaterhouseCoopers International
Limited
Haifa, Israel
September 13, 2021
We have served as the Company’s
auditor since 2021.
F- 2
Kost Forer Gabbay & Kasierer
144 Menachem Begin Road, Building A,
Tel-Aviv 6492102, Israel
Tel: +972-3-6232525
Fax: +972-3-5622555
ey.com
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
To the Stockholders and
Board of Directors Of
PLURISTEM THERAPEUTICS INC.
Opinion on the Financial Statements
We
have audited the accompanying consolidated balance sheets of Pluristem Therapeutics Inc. and its subsidiaries (the
“Company”) as of June 30, 2020, the related consolidated statements of operations, comprehensive loss, changes in stockholders’
equity and cash flows for the year ended June 30, 2020 and the related notes (collectively referred to as the “consolidated financial
statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position
of the Company at June 30, 2020, and the results of its operations and its cash flows for the year ended June 30, 2020, in conformity
with U.S. generally accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility
of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits.
We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required
to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations
of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal
control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to
assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ KOST FORER GABBAY &
KASIERER
A Member of Ernst & Young
Global
We have served as the Company’s
auditor from 2003 to 2020.
Tel Aviv, Israel
September 10, 2020
F- 3
PLURISTEM THERAPEUTICS INC. AND ITS
SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
U.S. Dollars in thousands (except share and
per share data)
June
30,
Note
2021
2020
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 31,241
$ 8,270
Short-term bank deposits
2f
33,709
37,514
Restricted cash
2f
597
555
Prepaid expenses and other current assets
3
1,824
2,122
Total current
assets
67,371
48,461
LONG-TERM ASSETS:
Long-term deposits
23,269
12,249
Restricted bank deposits
2g
-
404
Severance pay fund
664
631
Property and equipment, net
4
1,499
2,516
Operating lease right-of-use asset
6
728
1,259
Other long-term assets
7
12
Total long-term assets
26,167
17,071
Total assets
$ 93,538
$ 65,532
The accompanying notes are
an integral part of the consolidated financial statements.
F- 4
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
U.S. Dollars in thousands (except share and per share data)
June
30,
Note
2021
2020
LIABILITIES AND SHAREHOLDERS’
EQUITY
CURRENT LIABILITIES
Trade
payables
$ 2,526
$ 1,968
Accrued expenses
5,941
3,018
Operating lease
liability
6
634
1,020
Other
accounts payable
5
2,416
1,981
Total
current liabilities
11,517
7,987
LONG-TERM LIABILITIES
Accrued severance
pay
920
879
Operating lease
liability
6
100
565
Loan from the European Investment Bank (EIB)
7
23,850
-
Total
long-term liabilities
24,870
1,444
COMMITMENTS
AND CONTINGENCIES
8
SHAREHOLDERS’
EQUITY
Share capital:
9
Common shares, $ 0.00001 par value per share: Authorized: 60,000,000 shares Issued and outstanding: 31,957,782 shares as of June 30, 2021; 25,492,713 shares as of June 30, 2020
*
*
Additional paid-in
capital
387,172
336,257
Accumulated
deficit
( 330,021 )
( 280,156 )
Total
shareholders’ equity
57,151
56,101
Total liabilities
and shareholders’ equity
$ 93,538
$ 65,532
(*) Less than $1
The accompanying notes are
an integral part of the consolidated financial statements.
F- 5
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. Dollars in thousands (except share and per share data)
Year
ended June 30,
Note
2021
2020
Revenues
2h
-
23
Cost
of revenues
-
-
Gross
profit
-
23
Operating Expenses:
Research and
development expenses
( 30,533 )
( 23,096 )
Less:
participation grants by the Israel Innovation Authority, Horizon 2020 and other parties
467
1,519
Research and
development expenses, net
2l
( 30,066 )
( 21,577 )
General
and administrative expenses
( 20,557 )
( 7,922 )
Total operating
loss
( 50,623 )
( 29,476 )
Financial
income, net
10
758
324
Loss
for the year
$ ( 49,865 )
$ ( 29,152 )
Loss per share:
Basic
and diluted loss per share
$ ( 1.77 )
$ ( 1.60 )
Weighted
average number of shares used in computing basic and diluted loss per share
28,113,636
18,197,303
The accompanying notes are
an integral part of the consolidated financial statements.
F- 6
PLURISTEM THERAPEUTICS INC.
AND ITS SUBSIDIARIES
STATEMENTS OF CHANGES IN SHAREHOLDERS’
EQUITY
U.S. Dollars in thousands (except share and per share data)
Common Share
Additional Paid-in
Accumulated
Total Shareholders’
Shares
Amount
Capital
Deficit
Equity
Balance as of July 1, 2019
15,082,852
$ (*
)
$ 272,825
$ ( 251,004 )
$ 21,821
Share-based compensation to employees, directors and non-employee
consultants
357,755
(*
)
2,562
-
2,562
Issuance of common shares under Open Market Sales Agreement, net of aggregate issuance costs of $ 3,573 (Note 9b)
8,060,950
(*
)
43,262
-
43,262
Issuance of common shares related to May 2020 registered direct offering, net of issuance costs of $ 99 (Note 9d)
1,587,302
(*
)
14,901
-
14,901
Exercise of options by employees and non-employee consultants
15,884
(*
)
-
-
-
Exercise of warrants by investors (Note 9c)
386,678
(*
)
2,707
-
2,707
Round up of shares due to reverse share split effectuated
on July 25, 2019 (Note 9a)
1,292
(*
)
-
-
-
Loss for the year
-
-
-
( 29,152 )
( 29,152 )
Balance as of June 30, 2020
25,492,713
$ (*
)
$ 336,257
$ ( 280,156 )
$ 56,101
(*) Less
than $1
The accompanying notes are
an integral part of the consolidated financial statements.
F- 7
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARIES
STATEMENTS OF CHANGES IN SHAREHOLDERS’
EQUITY
U.S. Dollars in thousands (except share and per share data)
Common Share
Additional Paid-in
Accumulated
Total Shareholders’
Shares
Amount
Capital
Deficit
Equity
Balance as of
July 1, 2020
25,492,713
$ (*
)
$ 336,257
$ ( 280,156 )
$ 56,101
Share-based
compensation to employees, directors and non-employee consultants
591,033
(*
)
13,968
-
13,968
Issuance of common shares under ATM Agreement, net of issuance costs
of $ 380 (Note 9e)
1,045,097
(*
)
8,506
-
8,506
Issuance of common shares related to February 2021 registered direct offering net of issuance costs of $ 1,923 (Note 9g)
4,761,905
(*
)
28,077
-
28,077
Exercise of
options by employees and non-employee consultants
15,035
(*
)
-
-
-
Exercise of
warrants by investors (Note 9f)
51,999
(*
)
364
-
364
Loss
for the year
-
-
-
( 49,865 )
( 49,865 )
Balance
as of June 30, 2021
31,957,782
$ (*
)
$ 387,172
$ ( 330,021 )
$ 57,151
(*) Less than $1
The accompanying notes are an
integral part of the consolidated financial statements.
F- 8
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. Dollars in thousands
Year
ended June 30,
2021
2020
CASH FLOWS FROM OPERATING
ACTIVITIES:
Loss
for the year
$ ( 49,865 )
$ ( 29,152 )
Adjustments
to reconcile loss to net cash used in operating activities:
Depreciation
1,370
1,570
Share-based
compensation to employees, directors and non-employee consultants
13,968
2,562
Decrease (increase)
in prepaid expenses and other current assets and other long-term assets
303
( 150 )
Increase (decrease)
in trade payables
578
( 291 )
Decrease in
operating lease right-of-use asset and liability, net
( 321 )
( 295 )
Increase (decrease)
in other accounts payable, accrued expenses, other long-term liabilities and other current liabilities
3,353
( 638 )
Decrease (increase)
in interest receivable on short-term deposits
( 256 )
45
Long term interest
payable pursuant to EIB loan
78
-
Linkage differences
and interest on long-term deposits and restricted bank deposits
( 126 )
( 11 )
Accrued
severance pay, net
8
( 9 )
Net cash used
for operating activities
$ ( 30,910 )
$ ( 26,369 )
CASH FLOWS
FROM INVESTING ACTIVITIES:
Purchase of
property and equipment
$ ( 373 )
$ ( 270 )
Proceeds from
withdrawal of (investment in) short-term deposits
4,061
( 17,949 )
Investment
in long-term deposits and restricted bank deposits
( 10,953 )
( 12,239 )
Net cash used
for investing activities
$ ( 7,265 )
$ ( 30,458 )
CASH
FLOWS FROM FINANCING ACTIVITIES:
Proceeds related
to issuance of common shares, net of issuance costs
$ 36,589
$ 58,163
Proceeds related
to exercise of warrants
364
2,707
Proceeds
from EIB loan
24,449
-
Net cash provided
by financing activities
$ 61,402
$ 60,870
EFFECT
OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS
( 618 )
-
Increase in
cash, cash equivalents and restricted cash
22,609
4,043
Cash,
cash equivalents and restricted cash at the beginning of the period
9,229
5,186
Cash,
cash equivalents and restricted cash at the end of the period
$ 31,838
$ 9,229
The accompanying notes are an
integral part of the consolidated financial statements.
F- 9
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 1: - GENERAL
a. Pluristem Therapeutics Inc., a Nevada corporation (“Pluristem Therapeutics”),
was incorporated on May 11, 2001. Pluristem Therapeutics has a wholly owned subsidiary, Pluristem Ltd. (the “Subsidiary”),
which is incorporated under the laws of the State of Israel. In January 2020, the Subsidiary established a wholly owned subsidiary, Pluristem
GmbH (the “German Subsidiary” ) which is incorporated under the laws of Germany. Pluristem
Therapeutics, the Subsidiary and the German Subsidiary are referred to as the “Company” or “Pluristem”. The Subsidiary
and the German Subsidiary are referred to as the “Subsidiaries”.
The Company’s
common shares are traded on the Nasdaq Global Market and on the Tel-Aviv Stock Exchange under the symbol “PSTI”.
b. The Company is a bio-technology company focused in the field of regenerative medicine and operates in one
business segment. The Company is developing placenta-based cell therapy product candidates for the treatment of muscle trauma, hematological
disorders, radiation damage and inflammation.
The Company has incurred
an accumulated deficit of approximately $ 330,021 and incurred recurring operating losses and negative cash flows from operating activities
since inception. As of June 30, 2021, the Company’s total shareholders’ equity amounted to $ 57,151 . During the year ended June 30,
2021, the Company incurred losses of $ 49,865 and its negative cash flow from operating activities was $ 30,910 .
As
of June 30, 2021, the Company’s cash position (cash and cash equivalents, short-term bank deposits and long-term bank
deposits) totaled approximately $ 88,219 . The Company plans to continue to finance its operations from its current resources , by
entering into licensing or other commercial agreements, from grants to support its research and development activities from sales of
its equity securities and from the proceeds from the loan previously provided by the European Investment Bank (the
“EIB”, see also note 7), as well as the potential additional draw down of funds from the Finance Contract (as defined
herein) executed with the EIB, assuming applicable milestones will be achieved. Management believes that its current resources,
together with its existing operating plan, are sufficient for the Company to meet its obligations as they come due at least for a
period of twelve months from the date of the issuance of these consolidated financial statements. There are no assurances, however,
that the Company will be able to obtain an adequate level of financial resources that are required for the long-term development and
commercialization of its products.
NOTE 2:
- SIGNIFICANT ACCOUNTING POLICIES
The consolidated financial statements
have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) applied on consistent
basis.
a. Use of estimates
The preparation of
financial statements in conformity with generally accepted accounting principles requires management to make estimates, judgments, and
assumptions that are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions
can affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.
b. Functional currency
The
Company’s management believes that the dollar is the primary currency of the economic environment in which the Company and the
Subsidiaries operate. Thus, the dollar is the Company’s functional and reporting currency. Accordingly, non-dollar
denominated transactions and balances have been re-measured into the functional currency in accordance with Accounting Standards
Codification (“ASC”) 830, “Foreign Currency Matters”. All transaction gains and losses from the re-measured
monetary balance sheet items are reflected in the statements of income as financial income or expenses, as appropriate.
F- 10
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 2: - SIGNIFICANT ACCOUNTING POLICIES (CONT.)
c. Principles of consolidation
The consolidated financial
statements include the accounts of Pluristem Therapeutics and the Subsidiaries. Intercompany transactions and balances have been eliminated
upon consolidation.
d. Cash and cash equivalents
Cash equivalents
are short-term highly liquid investments that are readily convertible to cash with maturities of three months or less at the date acquired.
e. Short-term bank deposit
Bank deposits with
original maturities of more than three months but less than one year are presented as part of short-term investments. Deposits are presented
at their cost which approximates market values including accrued interest. Interest on deposits is recorded as financial income.
f. Restricted cash and short-term bank deposits
Short-term restricted bank deposits
and restricted cash used to secure derivative and hedging transactions and the Company’s credit line. The restricted cash and short-term
bank deposits are presented at cost which approximates market values including accrued interest.
g. Long-term restricted bank deposits
Long-term restricted bank deposits
with maturities of more than one year used to secure operating lease agreement are presented at cost which approximates market values
including accrued interest.
h. Revenue Recognition
Revenues are recognized when control of the promised goods
is transferred to the customer, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those
goods.
The Company determines revenue recognition through the
following steps:
●
identification of the contract with a customer;
●
identification of the performance obligations in the contract;
●
determination of the transaction price;
●
allocation of the transaction price to the performance obligations in the contract; and
●
recognition of revenue when, or as, the Company satisfies a performance obligation.
F- 11
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 2: - SIGNIFICANT ACCOUNTING POLICIES (CONT.)
i. Property and equipment
Property and equipment
are stated at cost, net of accumulated depreciation. Depreciation is calculated by the straight-line method over the estimated useful
lives of the assets, at the following annual rates:
%
Laboratory equipment
10 - 40
Computers and peripheral equipment
33
Office furniture and equipment
15
Leasehold improvements
The shorter of the expected useful life or the term of the lease.
j. Impairment of long-lived assets
The
Company’s long-lived assets are reviewed for impairment in accordance with ASC 360, “Property, Plant and
Equipment”, whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
Recoverability of assets to be held and used is measured by a comparison of the carrying amount of the assets to the future
undiscounted cash flows expected to be generated by the assets. If such assets are considered to be impaired, the impairment to be
recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. During fiscal
years 2021 and 2020, no triggering events were identified, and no impairment losses were recorded.
k. Accounting for share-based compensation
The Company accounts
for share-based compensation in accordance with ASC 718, “Compensation-Share Compensation” (“ASC 718”). ASC 718
requires companies to estimate the fair value of equity-based payment awards on the date of grant using an option-pricing model. The Company
estimates the fair value of share options granted using the Black-Scholes option-pricing model. The Company accounts for employees’ share-based
payment awards classified as equity awards (restricted shares (“RS”) or restricted share units (“RSUs”)) using
the grant-date fair value method. The fair value of share-based payment transactions is recognized as an expense over the requisite service
period, net of estimated forfeitures. The Company estimates forfeitures based on historical experience and anticipated future conditions.
The Company recognized compensation cost for an award with service conditions that has a graded vesting schedule using the accelerated
method based on the multiple-option award approach.
The Company measures
the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award.
The fair value
of service-based share option grants is estimated on the grant date using a Black-Scholes option-pricing model and compensation
expense related to share option grants is recognized on a graded vesting schedule over the vesting period. For share options
containing a market condition, the market conditions are required to be considered when calculating the grant date fair value. ASC
718 requires selection of a valuation technique that best fits the circumstances of an award. In order to reflect the substantive
characteristics of the market condition option award, a Monte Carlo simulation valuation model was used to calculate the grant date
fair value of such share options. Expense for the market condition share options is recognized over the derived service period as
determined through the Monte Carlo simulation model.
F- 12
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 2: - SIGNIFICANT ACCOUNTING POLICIES (CONT.)
In accordance with ASC 718, RS and
RSUs are measured at their fair value. All RS and RSUs to employees and directors granted during fiscal 2021 and 2020, were granted for
no consideration. Therefore, their fair value was equal to the share price at the date of grant, unless the RSUs include a market-based
condition in which case the fair value RSUs at the date of grant was calculated using the Monte Carlo model.
The fair value of
all RS and RSUs was determined based on the close trading price of the Company’s shares known at the grant date. The weighted average
grant date fair value of shares granted during fiscal 2021 and 2020, was $ 9.76 and $ 3.65 per share, respectively.
During fiscal years
2021 and 2020, there were no options granted to employees or directors.
l. Research and Development expenses, royalty bearing grants and non-royalty bearing grants
Research and development
expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, share-based
compensation expenses, payroll taxes and other employee benefits, subcontractors and materials used for research and development activities,
including clinical trials, manufacturing costs and professional services. All costs associated with research and developments are expensed
as incurred.
Grants
received from the Israel Innovation Authority (the “IIA”) were recognized when the grant becomes receivable, provided there
was reasonable assurance that the Company will comply with the conditions attached to the grant and there was reasonable assurance the
grant will be received. The grant is deducted from the research and development expenses as the applicable costs are incurred.
Research and
development expenses, net for the year ended June 30, 2021 and 2020 include participation in research and development expenses in the
amount of approximately $ 467 and $ 1,519 , respectively.
Clinical
trial expenses are charged to research and development expense as incurred. The Company accrues for expenses resulting from obligations
under contracts with clinical research organizations ( “ CROs ” ).
The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows
that do not match the periods over which materials or services are provided. The Company’s objective is to reflect the appropriate
trial expense in the consolidated financial statements by matching the appropriate expenses with the period in which services and efforts
are expended. In the event advance payments are made to a CRO, the payments are recorded as other assets, which will be recognized as
expenses as services are rendered.
During fiscal
years 2021 and 2020, the Company also received non-royalty bearing grants from the European Union research and development
consortiums, under Horizon 2020, and from the IIA, under the CRISPR-IL consortium, in the amount of approximately $ 566 and $ 1,227 , for
the year ended June 30, 2021 and 2020, respectively. The non-royalty bearing grants for funding the projects are recognized at the
time the Company is entitled to each such grant on the basis of the related costs incurred and recorded as a deduction from research
and development expenses.
m. Loss per share
Basic and diluted
loss per share is computed based on the weighted average number of common shares outstanding during each year. All outstanding share options
and unvested RSUs have been excluded from the calculation of the diluted loss per common share because all such securities are anti-dilutive
for each of the periods presented. The total weighted average number of shares related to the outstanding options, warrants and RSU’s
excluded from the calculations of diluted net earnings per share due to their anti-dilutive effect was 5,700,994 and 3,708,807 for the
years ended June 30, 2021 and 2020, respectively.
F- 13
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 2:
- SIGNIFICANT ACCOUNTING POLICIES (CONT.)
n. Income taxes
1. Deferred taxes
Income taxes
are computed using the asset and liability method. Under the asset and liability method, deferred income tax assets and liabilities are
determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the
currently enacted tax rates and laws. A valuation allowance is recognized to the extent that it is more likely than not that the deferred
taxes will not be realized in the foreseeable future.
2. Uncertainty in income taxes
The Company
follows a two-step approach in recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition
by determining if the available evidence indicates that it is more likely than not that the position will be sustained based on technical
merits. If this threshold is met, the second step is to measure the tax position as the largest amount that has more than a 50 % likelihood
of being realized upon ultimate settlement.
o. Concentration of credit risk
Financial instruments
that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents, restricted cash,
short-term deposits, long-term deposits and restricted deposits.
The majority
of the Company’s cash and cash equivalents, restricted cash and short-term and long-term deposits are mainly invested in dollar
instruments of major banks in Israel and in the United States. Deposits in the United States may be in excess of insured limits and are
not insured in other jurisdictions. Generally, these deposits may be redeemed upon demand and therefore bear minimal risk. The Company
invests its surplus cash in cash deposits in financial institutions and has established guidelines, approved by the Company’s Investment
Committee, relating to diversification and maturities to maintain safety and liquidity of the investments. The Company utilizes options
and forward contracts to protect against the risk of overall changes in exchange rates. The derivative instruments hedge a portion of
the Company’s non-dollar currency exposure. Counterparties to the Company’s derivative instruments are all major financial
institutions.
p. Severance pay
The majority
of the Company’s agreements with employees in Israel are subject to Section 14 of the Israeli Severance Pay Law, 1963 (“Severance
Pay Law”). The Company’s contributions for severance pay have replaced its severance obligation. Upon contribution of the
full amount of the employee’s monthly salary for each year of employment, no additional calculations are conducted between the parties
regarding the matter of severance pay and no additional payments are made by the Company to the employee. Further, the related obligation
and amounts deposited on behalf of the employee for such obligation are not stated on the balance sheet, as the Company is legally released
from the obligation to employees once the deposit amounts have been paid.
For some employees,
which their agreement is not subject to Section 14 of the Severance Pay Law, the Subsidiary’s liability for severance pay is calculated
pursuant to Israeli Severance Pay Law, based on the most recent salary of the employees multiplied by the number of years of employment,
as of the balance sheet date. Employees are entitled to one month’s salary for each year of employment or a portion thereof. The Company’s
liability for all of its employees is fully provided by monthly deposits with insurance policies and by an accrual. The value of these
policies is recorded as an asset in the Company’s balance sheet.
F- 14
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 2:
- SIGNIFICANT ACCOUNTING POLICIES (CONT.)
The
deposited funds include profits or losses accumulated up to the balance sheet date. The deposited funds may be withdrawn only upon the
fulfillment of the obligation pursuant to the Severance Pay Law or labor agreements. The value of the deposited funds is based on the
cash surrendered value of these policies, and includes immaterial profits or losses. Severance expenses for the years ended June 30, 2021
and 2020 were $ 748 and $ 604 , respectively.
q. Fair value of financial instruments
The carrying
amounts of the Company’s financial instruments, including cash and cash equivalents, restricted cash, short-term and restricted bank deposits,
accounts receivable and other current assets, trade payable and other accounts payable and accrued liabilities, approximate fair value
because of their generally short term maturities.
The Company
measures its derivative instruments at fair value under ASC 820, “Fair Value Measurement” (“ASC 820”). Fair value
is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction
between market participants.
As such, fair
value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset
or a liability. As a basis for considering such assumptions, ASC 820 establishes a three-tier value hierarchy, which prioritizes the inputs
used in the valuation methodologies in measuring fair value:
Level 1 - Quoted
prices (unadjusted) in active markets for identical assets or liabilities;
Level 2 - Inputs
other than Level 1 that are observable for the asset or liability, either directly or indirectly;
and
Level 3 - Unobservable
inputs for the asset or liability.
The fair value
hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring
fair value. The Company categorized each of its fair value measurements in one of these three levels of hierarchy.
The Company
measures its liability pursuant to the Finance Contract with the EIB based on the aggregate outstanding amount of the combined principal
and accrued interest. The Company does not reflect its liability for future royalty payments pursuant to the Finance Contract with the
EIB since the royalty payments are to be paid as a percentage of the Company’s future consolidated revenues, pro-rated to the amount
disbursed, beginning in the fiscal year 2024 and continuing up to and including its fiscal year 2030, which cannot be measured at this
time.
r. Derivative financial instruments
The Company accounts
for derivatives and hedging based on ASC 815, “Derivatives and hedging”, as amended and related interpretations (“ASC
815”). ASC 815 requires the Company to recognize all derivatives on the balance sheet at fair value. If a derivative meets the definition
of a hedge and is so designated, depending on the nature of the hedge, changes in the fair value of the derivative will either be offset
against the change in fair value of the hedged assets, liabilities, or firm commitments through earnings (for fair value hedge transactions)
or recognized in other comprehensive income (loss) until the hedged item is recognized in earnings (for cash flow hedge transactions).
If a derivative
does not meet the definition of a hedge, the changes in the fair value are included in earnings. Cash flows related to Company’s current
hedging are classified as operating activities. The Company enters into option contracts in order to limit the exposure to exchange rate
fluctuation associated with expenses mainly incurred in New Israeli Shekels (“NIS”). Since the derivative instruments that
the Company holds do not meet the definition of hedging instruments
under ASC 815, any gain or loss derived from such instruments is recognized immediately as “financial income, net”.
F- 15
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 2:
- SIGNIFICANT ACCOUNTING POLICIES (CONT.)
The Company measured
the fair value of the contracts in accordance with ASC 820. Foreign currency derivative contracts are classified within Level 2 as the
valuation inputs are based on quoted prices and market observable data of similar instruments. As of June 30, 2021 and 2020, the fair
value of the options contracts was immaterial and is presented in “other current assets” (see Note 3). The net gains (losses)
recognized in “Financial income, net” during the years ended June 30, 2021 and 2020, were $ 35 and $ 13 , respectively.
s. Leases
Operating leases
are included in operating lease right-of-use (“ROU”) asset, accrued expenses, and operating lease liability. ROU assets represent
Company’s right to use an underlying asset for the lease term and lease liabilities represent obligation to make lease payments arising
from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of
lease payments over the lease term. In determining the present value of lease payments, the Company uses the incremental borrowing rate
based on the information available at the lease commencement date as the rate implicit in the lease is not readily determinable. The determination
of the incremental borrowing rate requires management judgment based on information available at lease commencement. The operating lease
ROU assets also include adjustments for prepayments, accrued lease payments and exclude lease incentives. Lease terms may include options
to terminate the lease when it is reasonably certain that such options will be exercise. Operating lease cost is recognized on a straight-line
basis over the expected lease term. Lease agreements entered into after the adoption of ASC 842, “Leases” that include lease
and non-lease components are accounted for as a single lease component. Lease agreements with a noncancelable term of less than 12 months
are not recorded on the balance sheets.
t. Loss contingencies
The Company may become involved, from
time to time, in various lawsuits and legal proceedings which arise in the ordinary course of business. The Company records accruals for
loss contingencies to the extent that it concludes their occurrence is probable and that the related liabilities are estimable.
u. Recently Issued Accounting Pronouncements
ASU No. 2016-13 - “Financial
Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”):
In
June 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standards Update (“ASU”) 2016-13, “Financial Instruments - Credit
Losses (Topic 326): Measurement of Credit Losses on Financial Instruments” (“ASU 2016-13”). ASU 2016-13 changes
the impairment model for most financial assets and certain other instruments. For trade and other receivables, held-to-maturity debt
securities, loans, and other instruments, entities will be required to use a new forward-looking “expected loss” model
that generally will result in the earlier recognition of allowances for losses. The guidance also requires increased disclosures.
The amendments contained in ASU 2016-13 were originally effective for fiscal years beginning after December 15, 2019, including
interim periods within those fiscal years for the Company. In November 2019, the FASB issued ASU No. 2019-10, which
delayed the effective date of ASU 2016-13 for smaller reporting companies (as defined by the U.S. Securities and Exchange
Commission, “SRC”) to fiscal years beginning after December 15, 2022, including interim periods. Early adoption is
permitted. The Company meets the definition of an SRC and is adopting the deferral period for ASU 2016-13. The guidance
requires a modified retrospective transition approach through a cumulative-effect adjustment to retained earnings as of the
beginning of the period of adoption. The Company is currently evaluating the impact of the adoption of ASU 2016-13 on its
consolidated financial statements but does not expect that the adoption of this standard will have a material impact on its
consolidated financial statements.
v. Comprehensive loss
For all periods presented, loss is
the same as comprehensive loss as there are no comprehensive income items.
F- 16
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 3: - PREPAID EXPENSES AND OTHER CURRENT ASSETS
June 30,
2021
2020
Accounts receivable from the Horizon 2020 grants
$ 1,089
$ 1,071
Prepaid expenses
333
445
Accounts receivable from the IIA
-
142
Value Added Tax (VAT) receivables
382
336
Accounts receivable from the Ministry of Economy and Industry
19
35
Derivatives not designated as hedge instruments
1
67
Other receivables
-
26
Total
$ 1,824
$ 2,122
NOTE 4: - PROPERTY AND EQUIPMENT, NET
June 30,
2021
2020
Cost:
Laboratory equipment
$ 6,715
$ 6,514
Computers and peripheral equipment
1,473
1,322
Office furniture and equipment
681
681
Leasehold improvements
8,662
8,661
Total Cost
17,531
17,178
Accumulated depreciation:
Laboratory equipment
6,152
5,955
Computers and peripheral equipment
1,310
1,221
Office furniture and equipment
663
646
Leasehold improvements
7,907
6,840
Total accumulated depreciation
16,032
14,662
Property and equipment, net
$ 1,499
$ 2,516
Depreciation expenses amounted to $ 1,370
and $ 1,570 for the years ended June 30, 2021 and 2020, respectively.
During the fiscal years ended June 30,
2021 and 2020, the Company recorded a reduction of $ 0 and $ 74 , respectively, to the cost accumulated depreciation of fully depreciated
equipment no longer in use.
F- 17
PLURISTEM THERAPEUTICS INC. AND ITS SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 5: - OTHER ACCOUNTS
PAYABLE
June 30,
2021
2020
Accrued vacation and recuperation
$ 1,203
$ 928
Deferred income from the Horizon 2020 grant and CRISPR-IL
40
126
Accrued payroll
612
489
Payroll institutions
561
438
Total
$ 2,416
$ 1,981
NOTE 6: - LEASES
The Company has
various operating leases for office space that expire through fiscal 2022 and vehicles that expire through fiscal 2025. Below is a summary
of the Company’s operating right-of-use assets and operating lease liabilities as of June 30, 2021:
June 30,
2021
2020
Operating right-of-use assets
$ 728
$ 1,259
Operating lease liabilities, current
634
1,020
Operating lease liabilities long-term
100
565
Total operating lease liabilities
$ 734
$ 1,585
Minimum lease payments for the Company’s ROU assets
over the remaining lease periods as of June 30, 2021 are as follows:
June 30,
2021
2022
664
2023
99
2024
5
Total undiscounted lease payments
$ 768
Less: Interest
34
Present value of lease liabilities
$ 734
F- 18
PLURISTEM THERAPEUTICS INC. AND ITS
SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 6: - LEASES (CONT.)
The components of lease expense and supplemental cash flow
information related to leases for the year ended June 30, 2021 were as follows:
Year ended June 30,
2021
2020
Components of lease expense
Operating lease cost, net *
$ 984
$ 919
Sublease income
$ 55
$ 51
Supplemental cash flow information
Cash paid for amounts included in the measurement of lease liabilities
$ 1,214
$ 1,152
Supplemental non-cash information related to lease liabilities arising from obtaining ROU assets
$ 154
$ 83
* The operating lease costs are presented net after elimination
of deferred participation payments in amount of $ 248 .
As of June 30, 2021,
the weighted average remaining lease term is 1.2 years, and the weighted average discount rate is 10 percent. The discount rate was determined
based on the estimated collateralized borrowing rate of the Company, adjusted to the specific lease term and location of each lease.
NOTE 7: - LOAN FROM THE EIB
On April
30, 2020, Pluristem entered into a finance contract (the “Finance Contract”) with the
EIB, pursuant to which Pluristem, through the German Subsidiary can obtain a loan in the amount of up to € 50 million, subject to
certain milestones being reached (the “Loan”), payable in three tranches, with the first tranche consisting of € 20 million,
second of € 18 million and third of € 12 million for a period of 36 months from the signing of the Finance Contract.
The tranches will be treated independently,
each with its own interest rate and maturity period. The interest rate is 4 % in the aggregate (consisting of a 0 % fixed interest rate
and a 4 % deferred interest rate payable upon maturity, respectively) per year for the first tranche, 4 % in the aggregate (consisting of
a 1 % fixed interest rate and a 3 % deferred interest rate payable upon maturity, respectively) per year for the second tranche and 3 % (consisting
of a 1 % fixed interest rate and a 2 % deferred interest rate payable upon maturity, respectively) per year for the third tranche.
In addition to any interest
payable on the Loan, the EIB is entitled to receive royalties from future revenues, if any, of Pluristem for a period of seven years
starting in 2024, in an amount equal to between 0.2 % to 2.3 % of the Company’s consolidated revenues, pro-rated to the amount
disbursed from the Loan to Pluristem beginning in the fiscal year 2024 and continuing up to and including its fiscal year 2030.
During June 2021, Pluristem received
the first tranche in an amount of $ 24,449 (€ 20 million) of the Finance Contract. The amount received is due on June 1, 2026 and bears
annual interest of 4 % to be paid with the principal of the Loan. As of June 30, 2021, the linked principal balance in the amount of $ 23,772
and the interest accrued in the amount of $ 78 are presented as part of the Loan at long term liabilities (See also note 8h).
F- 19
PLURISTEM THERAPEUTICS INC. AND ITS
SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 8: - COMMITMENTS AND CONTINGENCIES
a. As of June 30, 2021, an amount of $ 597 of cash and deposits was
pledged by the Subsidiary to secure its credit line and bank guarantees.
b. Under the Law for the Encouragement of Industrial Research and
Development, 1984, (the “Research Law”), research and development programs that meet specified criteria and are approved
by the IIA are eligible for grants of up to 50 % of the project’s expenditures, as determined by the research committee, in exchange
for the payment of royalties from the sale of products developed under the program. Regulations under the Research Law generally provide
for the payment of royalties to the IIA of 3 % on sales of products and services derived from a technology developed using these grants
until 100 % of the dollar-linked grant is repaid. The Company’s obligation to pay these royalties is contingent on its actual sale
of such products and services. In the absence of such sales, no payment is required. Outstanding balance of the grants will be subject
to interest at a rate equal to the 12 month LIBOR applicable to dollar deposits that is published on the first business day of each calendar
year. Following the full repayment of the grant, there is no further liability for royalties.
Through June 30, 2021, total grants
obtained aggregated to approximately $ 27,743 and total royalties paid and accrued amounted to $ 169 . As of June 30, 2021, the Company’s
contingent liability in respect to royalties to the IIA amounted to $ 27,574 , not including LIBOR interest as described above.
c. The Company has been awarded a marketing
grant under the “Smart Money” program of the Israeli Ministry of Economy and Industry. The program’s aim is to assist
companies to extend their activities in international markets. The goal market that was chosen was Japan. The Israeli government granted
the Company budget resources that are intended to be used to advance the Company’s product candidate towards marketing in Japan
and for regulatory activities there. As part of the program, the Company will repay royalties of 5 % from the Company’s income in
Japan during five years, starting the year in which the Company will not be entitled to reimbursement of expenses under the program and
will be spread for a period of up to 5 years or until the amount of the grant is fully paid .
As of June 30, 2021, total grants
obtained under this Smart Money program amounted to approximately $ 112 . As of June 30, 2021, the Company’s contingent liability with respect
to royalties for this “Smart Money” program was $ 112 and no royalties were paid or accrued.
d. The Company was awarded an additional
Smart Money grant of approximately $ 229 from Israel’s Ministry of Economy and Industry to facilitate certain marketing and business
development activities with respect to its advanced cell therapy products in the Chinese market, including Hong Kong. The Israeli government
granted the Company budget resources that are intended to be used to advance the Company’s product candidate towards marketing
in the China-Hong Kong markets. The Company will also receive close support from Israel’s trade representatives stationed in China,
including Hong Kong, along with experts appointed by the Smart Money program. As part of the program, the Company will repay royalties
of 5 % from the Company’s revenues in the region for a five year period, beginning the year in which the Company will not be entitled
to reimbursement of expenses under the program and will be spread for a period of up to 5 years or until the amount of the grant is fully
paid .
e. As of June 30, 2021, the aggregate amount of grant obtained from
this Smart Money program was approximately $ 160 . As of June 30, 2021, the Company’s contingent liability with respect to royalties for
this “Smart Money” program is $ 160 and no royalties were paid or accrued.
F- 20
PLURISTEM THERAPEUTICS INC. AND ITS
SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE
8: - COMMITMENTS AND CONTINGENCIES (CONT.)
f. In September 2017, the Company signed
an agreement with the Tel-Aviv Sourasky Medical Center (Ichilov Hospital) to conduct a Phase I/II trial of PLX-PAD cell therapy for the
treatment of Steroid-Refractory Chronic Graft-Versus-Host-Disease (“ cGVHD ”).
As part
of the agreement with the Tel-Aviv Sourasky Medical Center (Ichilov Hospital), the Company will pay royalties of 1 % from its net sales
of the PLX-PAD product relating to cGVHD , with a maximum aggregate royalty amount of approximately
$ 250 .
g. The Company was awarded a marketing grant of approximately $ 52
under the “Shalav” program of the Israeli Ministry of Economy and Industry. The grant is intended to facilitate certain marketing
and business development activities with respect to the Company’s advanced cell therapy products in the U.S. market. As part of
the program, the Company will repay royalties of 3 %, but only with respect to the Company’s revenues in the U.S. market in excess of $ 250
of its revenues in fiscal year 2018, upon the earlier of the five year period beginning the year in which the Company will not be entitled
to reimbursement of expenses under the program and/or until the amount of the grant, which is linked to the Consumer Price Index, is fully
paid.
As of June 30, 2021, total grants obtained
under the “Shalav” program amounted to approximately $ 52 . As of June 30, 2021, the Company’s contingent liability with respect
to royalties for the “Shalav” program was $ 52 and no royalties were paid or accrued.
h. On April 30, 2020, Pluristem entered into the Finance Contract
with the EIB, pursuant to which the German Subsidiary can obtain the Loan in the amount of up to € 50 million, subject to certain
milestones being reached, payable in three tranches. The first tranche in amount of $ 23,772 (€ 20 million) was received during June
2021.
The EIB is entitled to receive royalties
from future revenues, if any, of Pluristem for a period of seven years starting in 2024, in an amount equal to between 0.2 % to 2.3 % of
the Company’s consolidated revenues, pro-rated to the amount disbursed from the Loan to Pluristem beginning in the fiscal year 2024
and continuing up to and including its fiscal year 2030.
NOTE 9: - SHAREHOLDERS’ EQUITY
(1) The Company’s authorized common shares consist of 60,000,000 shares
with a par value of $ 0.00001 per share. All shares have equal voting rights and are entitled to one vote per share in all matters to
be voted upon by shareholders. The shares have no pre-emptive, subscription, conversion or redemption rights and may be issued only as
fully paid and non-assessable shares. Holders of the common shares are entitled to equal ratable rights to dividends and distributions
with respect to the common share, as may be declared by the Board of Directors out of funds legally available. The Company’s authorized
preferred shares consist of 1,000,000 shares of preferred share, par value $ 0.00001 per share, with series, rights, preferences, privileges
and restrictions as may be designated from time to time by the Company’s Board of Directors. No preferred shares have
been issued.
F- 21
PLURISTEM THERAPEUTICS INC. AND ITS
SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 9: - SHAREHOLDERS’ EQUITY (CONT.)
a. Reverse share split:
In July 2019, the Board of Directors
approved a 1-for-10 reverse share split of the Company’s (a) authorized common shares; (b) issued and outstanding common shares and (c)
authorized preferred shares. The reverse split became effective on July 25, 2019. The reverse share split did not have any effect on the
stated par value of the common shares. All common shares, options, warrants and securities convertible or exercisable into common shares,
as well as loss per share, were adjusted to give retroactive effect to this reverse share split for all periods presented.
b. Pursuant to a shelf registration on Form S-3 declared effective by the Securities and Exchange Commission on June 23, 2017, on February 6, 2019, the Company entered into the Open Market Sale Agreement SM (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) which provides that, upon the terms and subject to the conditions and limitations in the sales agreement, the Company may elect, from time to time, to offer and sell common shares having an aggregate offering price of up to $ 50,000 through Jefferies acting as sales agent. During the year ended June 30, 2019, the Company sold 236,800 common shares under the Sales Agreement at an average price of $ 9.70 per share for aggregate net proceeds of approximately $ 2,051 , net of issuance expenses of $ 255 .
During the year ended June 30, 2020,
the Company sold 8,060,950 common shares under the Sales Agreement at an average price of $ 5.81 per share for aggregate net proceeds of
approximately $ 43,262 , net of issuance expenses of $ 3,573 .
On June 30, 2020, this shelf registration
statement on Form S-3 expired, and as a result thereof, the Sales Agreement was terminated.
c. During the year ended June 30, 2020, a total of 386,678 warrants
to purchase shares from the April 2019 offering were exercised by investors at an exercise price of $ 7.00 per share, resulting in the
issuance of 386,678 common shares for net proceeds of approximately $ 2,707 .
d. On May 5, 2020, the Company entered into a securities purchase
agreement with two institutional investors (the “Investors”) pursuant to which the Company sold, in a registered public offering
directly to the Investors, 1,587,302 common shares for net proceeds of approximately $ 14,901 .
e. Pursuant to a shelf registration on Form S-3 declared effective
by the SEC on July 23, 2020, in July 2020 the Company entered into a new Open Market Sale Agreement (“ATM Agreement”) with
Jefferies, which provides that, upon the terms and subject to the conditions and limitations in the ATM Agreement, the Company may elect,
from time to time, to offer and sell common shares having an aggregate offering price of up to $ 75,000 through Jefferies acting as sales
agent. During the year ended June 30, 2021, the Company sold 1,045,097 common shares under the ATM Agreement at an average price of $ 8.50
per share for aggregate net proceeds of approximately $ 8,506 , net of issuance expenses of $ 380 .
f. During the year ended June 30, 2021,
a total of 519,990 warrants to purchase common shares from the April 2019 offering were exercised
by investors at an exercise price of $ 7.00 per share, resulting in the issuance of 51,999 common shares for net proceeds of approximately
$ 364 .
g. On February 2, 2021, the Company, entered into a securities purchase
agreement, with certain institutional investors, pursuant to which the Company agreed to issue and sell, in a registered direct offering,
by the Company directly to the investors, 4,761,905 common shares for gross proceeds of $ 30,000 . The aggregate net proceeds were approximately
$ 28,077 , net of issuance expenses of $ 1,923 .
F- 22
PLURISTEM THERAPEUTICS INC. AND ITS
SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 9: - SHAREHOLDERS’
EQUITY (CONT.)
h. Share options, RS and RSUs to employees, directors and consultants:
The Company adopted, after
receiving shareholder approval, the 2005 Share Option Plan in 2005 (the “2005 Plan”). Under the 2005 Plan, share
options, RS and RSUs were granted to the Company’s officers, directors, employees and consultants. The 2005 Plan expired on
December 31, 2018. The Company adopted, after receiving shareholder approval, the 2016 Equity Incentive Plan in 2016 (the
“2016 Plan”). Under the 2016 Plan, share options, RS and RSUs may be granted to the Company’s officers, directors,
employees and consultants or the officers, directors, employees and consultants of the Subsidiaries. In addition, at
the Company’s annual meeting of its shareholders, held on June 13, 2019, the Company’s shareholders approved the 2019
Equity Compensation Plan (the “2019 Plan”).
Under the 2019 Plan, share options,
RS and RSUs may be granted to the Company’s officers, directors, employees and consultants or the officers, directors, employees
and consultants of the Subsidiary.
As of June 30, 2021, the number of common
shares authorized for issuance under the 2016 Plan amounted to 879,945 for calendar year 2021, of which 859,945 are available for future
grant during calendar year 2021 under the 2016 Plan. As of June 30, 2021, the number of common shares authorized for issuance under the
2019 Plan amounted to 3,783,807, all of which are available for future grant under the 2019 Plan.
(2) Options
to consultants:
A summary of the share options to non-employee
consultants under the 2005 Plan and 2016 Plan is as follows:
Year ended June 30, 2020
Number
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Terms
(in years)
Aggregate
Intrinsic
Value
Price
Share options outstanding at beginning of period
89,580
$ -
Share options granted
1,050
$ -
Share options exercised
( 15,884 )
$ -
Share options forfeited
( 19,875 )
$ -
Share options outstanding at end of the period
54,871
$ -
7.89
$ 485
Share options exercisable at the end of the period
48,621
$ -
7.81
$ 430
Share options vested and expected to vest at the end of the period
54,871
$ -
7.89
$ 485
F- 23
PLURISTEM THERAPEUTICS INC. AND ITS
SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 9: - SHAREHOLDERS’ EQUITY (CONT.)
Year ended June 30, 2021
Number
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Terms
(in years)
Aggregate
Intrinsic
Value
Price
Share options outstanding at beginning of period
54,871
$ -
Share options granted
-
$ -
Share options exercised
( 15,035 )
$ -
Share options forfeited
-
$ -
Share options outstanding at end of the period
39,836
$ -
6.99
$ 158
Share options exercisable at the end of the period
36,086
$ -
6.94
$ 143
Share options unvested
3,750
Share options vested and expected to vest at the end of the period
39,836
$ -
6.99
$ 158
Compensation expenses
related to share options granted to consultants were recorded as follows:
Year ended June 30,
2021
2020
Research and development expenses
$ -
$ ( 35 )
General and administrative expenses
11
64
$ 11
$ 29
(3) RS
and RSUs to employees and directors:
The following table
summarizes the activity related to unvested RS and RSUs granted to employees and directors under the 2005 Plan, 2016 Plan and 2019 Plan
for the years ended June 30, 2021 and 2020:
Year ended June 30,
2021
2020
Number
Unvested at the beginning of period
415,194
795,633
Granted
2,646,120
19,500
Forfeited
( 76,804 )
( 101,256 )
Vested
( 580,095 )
( 298,683 )
Unvested at the end of the period
2,404,415
415,194
Expected to vest after the end of period
2,404,415
402,491
F- 24
PLURISTEM THERAPEUTICS INC. AND ITS
SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 9: - SHAREHOLDERS’
EQUITY (CONT.)
Compensation expenses
related to RS and RSUs granted to employees and directors were recorded as follows:
Year ended June 30,
2021
2020
Research and development expenses
$ 1,363
$ 578
General and administrative expenses
12,253
1,786
$ 13,616
$ 2,364
Unamortized compensation expenses
related to RSUs granted to employees and directors is approximately $ 10,174 to be recognized by the end of March 2025.
Market-based awards
In September 2020, the Company granted
two of its executive officers an aggregate of 1,000,0000 RSUs (500,000 each) under the 2019 Plan.
The RSUs will vest in full upon
the achievement of a milestone of the Company increasing the market capitalization of its common shares on the Nasdaq
Global Market to $ 550,000 within no more than three years from the date of grant.
For market-based awards, the Company
determines the grant-date fair value utilizing a Monte Carlo simulation model, which incorporates various assumptions including expected
share price volatility, risk-free interest rates, and the expected date of a qualifying event. The Company estimates the volatility of
the common shares based on its historical share price volatility for a period of 4 years from the grant date based on the daily changes
in the share price. The risk-free interest rate is based on the zero-coupon yield of U.S. Treasury bonds for the expiration date of the
RSUs.
The fair value
of the market-based award uses the assumptions noted in the following table:
Risk-free interest rates
0.16 %
Dividend yield
0 %
Expected volatility
69.44 %
The Company recognizes
compensation expenses for the value of its market-based awards based on the results of the Monte Carlo valuation model. The fair
value of the market-based awards granted on the grant date was $ 7.28 per share and the expected time for the market condition to
achieve, based on the Monte Carlo valuation model, is thirteen and a half months from the date of the grant. As of June 30, 2021,
the Company recognized $ 5,156 of expenses included in general and administrative expenses.
F- 25
PLURISTEM THERAPEUTICS INC. AND ITS
SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 9: - SHAREHOLDERS’
EQUITY (CONT.)
(4) RSUs
to consultants:
The following table
summarizes the activity related to unvested RS and RSUs granted to consultants for the years ended June 30, 2021 and 2020:
Year ended June 30,
2021
2020
Number
Unvested at the beginning of period
6,250
30,107
Granted
110,000
42,000
Forfeited
( 29,063 )
( 6,785 )
Vested
( 10,938 )
( 59,072 )
Unvested at the end of the period
76,249
6,250
Compensation expenses
related to RSUs granted to consultants were recorded as follows:
Year ended June 30,
2021
2020
Research and development expenses
$ 176
$ 14
General and administrative expenses
165
155
$ 341
$ 169
i. Summary of warrants and options:
Warrants / Options
Exercise
Price per
Share
Options and
Warrants
for Common
Share
Options and
Warrants
Exercisable
for Common
Share
Weighted
Average
Remaining
Contractual
Terms
(in years)
Warrants:
$ 7.00
2,418,466
2,418,466
2.77
$ 14.00
762,028
762,028
1.06
Total warrants
3,180,494
3,180,494
Options:
$ 0.00001
39,835
36,085
6.98
Total options
39,835
36,085
Total warrants and options
3,220,329
3,216,579
This summary does not include 2,480,664 RSUs that are not vested as
of June 30, 2021.
F- 26
PLURISTEM THERAPEUTICS INC. AND ITS
SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS
U.S. Dollars in thousands (except share and per share amounts)
NOTE 10: - FINANCIAL INCOME, NET
Year ended June 30,
2021
2020
Foreign currency translation differences, net
$ 332
$ ( 41 )
Bank and broker commissions
( 23 )
( 32 )
Interest income on deposits
492
384
Gain from derivatives and fair value hedge derivatives
35
13
EIB loan interest expenses
( 78 )
-
$ 758
$ 324
NOTE 11: - TAXES ON INCOME
A. Tax rates applicable to the Company:
1. Pluristem Therapeutics:
The U.S. federal
tax rate applicable to Pluristem Therapeutics is the corporate federal tax rate of 21 %, which is the result of the Tax Cuts and Jobs Act
of 2017 (the “Tax Act”). Such corporate tax rate excludes state tax and local tax, if any, which rates depend on the state and
city in which Pluristem Therapeutics conducts its business.
On December 22, 2017, the Tax Act
was signed into law in the United States, lowering the corporate federal income tax rate from 35 % to 21 %, effective January 1, 2018.
The Tax Act provided for a one-time
transition tax on certain foreign earnings for the tax year 2017, and taxation of Global Intangible Low-Taxed Income (“GILTI”)
earned by foreign subsidiaries beginning after
December 31, 2017. The GILTI tax imposes
a tax on foreign income in excess of a deemed return on tangible assets of foreign corporations. The Tax Act also makes certain changes
to the depreciation rules and implements new limits on the deductibility of certain executive compensation paid by Pluristem Therapeutics.
Finally, while the Tax Act removes the 20 year limitation on net operating losses generated after December 31, 2017, all losses generated
after December 31, 2017 can only be used to offset 80 % of net income in the year they will be utilized.
This re-measurement was fully offset
by a valuation allowance, resulting in no impact to the Company’s income tax expense for the fiscal year ended June 30, 2021. As
a result, the Company’s financial results reflect in the income tax effects of the Tax Act, for which the accounting under ASC 740 is
complete.
There was no one-time transition tax
for the Company under the Tax Act, nor will there be GILTI tax due for the current year, since the Subsidiary had losses for every year
to date.
In January 2018, Pluristem Therapeutics
registered as an Israeli resident with the Israel Tax Authority (the “ITA”) and the Israeli Value Added Tax Authorities. As
a result, as of such date, Pluristem Therapeutics is classified as a dual resident for tax purposes, as a resident in both Israel and
the United States.
F- 27
PLURISTEM
THERAPEUTICS INC. AND ITS SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
Dollars in thousands (except share and per share amounts)
NOTE
11: - TAXES ON INCOME (CONT.)
In
June 2018, Pluristem Therapeutics and the Subsidiary submitted an election notice to the ITA to file a consolidated tax return in Israel
commencing with the 2018 tax year.
2. The
Subsidiary:
Consolidated
taxable income of Pluristem Therapeutics and the Subsidiary (the “Consolidated tax unit”) is subject to tax at the rate of
23 % in 2021 and 2020.
The
Consolidated tax unit is filing its consolidated tax reports in dollars based on specific regulations of the ITA which allow, in specific
circumstances, filing tax reports in dollars (“Dollar Regulations”). Under the Dollar Regulations, the tax liability is calculated
in dollars according to certain orders. The tax liability, as calculated in dollars, is translated into NIS according to the exchange
rate as of June 30 of each year.
The
Subsidiary has not received final tax assessments since its incorporation, however the assessments of the Subsidiary are deemed final
through 2015.
The
Law for the Encouragement of Capital Investments, 1959 (the “Law”):
The
Subsidiary has programs which meet the criteria of a “Beneficiary Enterprise”, in accordance with the Law, under the Alternative
Benefit Track starting with 2007 as the election year (the “2007 Program”) and 2012 as an election year to the expansion of
its “Beneficiary Enterprise” program (the “2012 Program”).
Under
the 2012 Program, the Subsidiary, which was located in the “Other National Priority Zone” with respect to the year 2012, would
be tax exempt in the first two years of the benefit period and subject to tax at the reduced rate of 10 %- 25 % for a period of five to
eight years for the remaining benefit period (dependent on the level of foreign investments).
In
respect of expansion programs pursuant to Amendment No. 60 to the Law, the duration of the benefit period has been amended, such
that it starts at the later of the election year and the first year the Company earns taxable income provided that 12 years have not
passed since the beginning of the election year and for companies in National Priority Zone A - 14 years have not passed since the
beginning of the election year.
The
benefit period for the Subsidiary’s 2007 Program expired in 2018 (12 years since the beginning of the election year– 2007) and
the benefit period for the Subsidiary’s 2012 Program is expected to expire in 2023 (12 years since the beginning of the election year
- 2012).
If
a dividend is distributed out of tax exempt profits, as detailed above, the Subsidiary will become liable for taxes at the rate applicable
to its profits from the Beneficiary Enterprise in the year in which the income was earned (tax at the rate of 10-25%, dependent on the
level of foreign investments) and to a withholding tax rate of 15% (or lower, under an applicable tax treaty).
F- 28
PLURISTEM
THERAPEUTICS INC. AND ITS SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
Dollars in thousands (except share and per share amounts)
NOTE
11: - TAXES ON INCOME (CONT.)
Accelerated
depreciation:
The
Subsidiary is eligible for deduction of accelerated depreciation on buildings, machinery and equipment used by the “Beneficiary
Enterprise” at a rate of 200 % (or 400 % for buildings but not more than 20 % depreciation per year) from the first year of the assets
operation.
Conditions
for the entitlement to the benefits:
The
above mentioned benefits are conditional upon the fulfillment of the conditions stipulated by the Law, regulations promulgated thereunder,
and the Ruling with respect to the beneficiary enterprise. Non-compliance with the conditions may cancel all or part of the benefits
and refund of the amount of the benefits, including interest. The management believes that the Subsidiary is meeting the aforementioned
conditions.
Amendments
to the Law:
In
December 2010, the “Knesset” (Israeli Parliament) passed the Law for Economic Policy for 2011 and 2012 (Amended Legislation),
2011, which prescribes, among others, amendments in the Law (“Amendment No. 68”). Amendment No. 68 became effective as of
January 1, 2011. According to Amendment No. 68, the benefit tracks in the Law were modified and a flat tax rate became applicable to
a company for all preferred income under its status as a preferred company with a preferred enterprise.
On
August 5, 2013, the Knesset issued the Law for Changing National Priorities (Legislative Amendments for Achieving Budget Targets for
2013 and 2014), 2013 which consists of Amendment No. 71 to the Law (“Amendment No. 71”). According to Amendment No. 71, the
tax rate on preferred income form a preferred enterprise in 2014 and thereafter will be 16 % (in development area A it will be 9 %).
Amendment
No. 71 also prescribes that any dividends distributed to individuals or foreign residents from the preferred enterprise’s earnings as
above will be subject to tax at a rate of 20 %.
The
Subsidiary did not apply Amendment No. 71 with respect to the preferred enterprise status, but may choose to apply Amendment No. 71 in
the future.
Innovation
Box Regime “Technological Preferred Enterprise”:
In
December 2016, the Knesset approved amendments to the Law that introduce an innovation box regime (the “Innovation Box
Regime”) for intellectual property (IP)-based companies, enhance tax incentives for certain industrial companies and reduce
the standard corporate tax rate and certain withholding rates starting in 2017.
The
Innovation Box Regime was tailored by the Israeli government to a post-base erosion and profit shifting world, encouraging multinationals
to consolidate IP ownership and profits in Israel along with existing Israeli research and development (“R&D”) functions.
Tax benefits created to achieve this goal include a reduced corporate income tax rate of 6 % on IP-based income and on capital gains from
future sale of IP.
The
6 % rate would apply to qualifying Israeli companies that are part of a group with global consolidated revenue of over NIS 10 billion
(approximately $ 2.9 billion). Other qualifying companies with global consolidated revenue below NIS 10 billion, would be subject to a
12 % tax rate.
F- 29
PLURISTEM
THERAPEUTICS INC. AND ITS SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
Dollars in thousands (except share and per share amounts)
NOTE
11: - TAXES ON INCOME (CONT.)
However,
if the Israeli company is located in Jerusalem or in certain northern or southern parts of Israel, the tax rate is further reduced to
7.5 %. Additionally, withholding tax on dividends for foreign investors would be subject to a reduced rate of 4 % for all qualifying companies
(unless further reduced by a treaty).
Entering
the regime is not conditioned on making additional investments in Israel, and a company could qualify if it invested at least 7 % of the
last three years’ revenue in R&D (or incurred at least NIS 75 million in R&D expenses per year) and met one of the following
three conditions:
1.
At least 20 % of its employees are R&D employees engaged in R&D (or employs, in total, more than 200 R&D employees);
2.
Venture capital investments in the aggregate of NIS 8 million were previously made in the company; or
3.
Average annual growth over three years of 25 % in sales or employees.
Companies
not meeting the above conditions may still be considered as a qualified company at the discretion of the IIA. Companies wishing to exit
from the regime in the future will not be subject to claw back of tax benefits. The Knesset also approved a stability clause in order
to encourage multinationals to invest in Israel. Accordingly, companies will be able to confirm the applicability of tax incentives for
a 10-year period under a pre-ruling process. Further, in line with the new Organization for Economic Co-operation and Development Nexus
Approach, the Israeli Finance Minister will promulgate regulations to ensure companies are benefiting from the regime to the extent qualifying
research and development expenditures are incurred.
The
regulations were set to be finalized by March 31, 2017, with new amendments to the Law coming into effect after the regulations have
been finalized.
Taxable
income which is not produced as part of “Preferred Enterprise” income will be taxed at the regular tax rate ( 23 % in 2020).
As
of June 30, 2021, the Company’s management believes that the Company meets the conditions mentioned above to be considered as a
Technological Preferred Enterprise.
3. Pluristem
GmbH:
The
tax rate applicable to the German Subsidiary is the corporate tax rate of 15%, which is derived from the German Corporation Tax Act and
Solidarity surcharge of 5.5% from the 15% corporate tax rate. This corporate tax rate excludes trade tax, which rate depends on the municipality
in which the German Subsidiary conducts its business. Trade tax is calculated on the basis of the trade income, to which the tax rate
of 3.5% is applied. The measured amount is then multiplied by the applicable rate of assessment, the registered office of the German
Subsidiary is in Potsdam, and in Potsdam, the applicable rate of assessment is 455%.
B. Carryforward
losses for tax purposes
As
of June 30, 2021, Pluristem Therapeutics had a U.S. federal net operating loss carryforward for income tax purposes in the amount of
approximately $ 34,836 . Net operating loss carryforwards arising in taxable years, can be carried forward and offset against taxable income
for 20 years and expire between 2023 and 2038.
Utilization
of U.S. net operating losses may be subject to substantial annual limitations due to the “change in ownership” provisions of
the Internal Revenue Code of 1986 and similar state provisions. The annual limitation may result in the expiration of net operating losses
before utilization.
In
January 2018, Pluristem Therapeutics registered as an Israeli resident with the ITA and the Israeli Value Added Tax Authorities. As of
June 30, 2021, Pluristem Therapeutics and the Subsidiary consolidated accumulated losses, for tax purposes, are approximately $ 86,949 ,
which may be carried forward and offset against taxable business income and business capital gain in the future for an indefinite period.
The
Subsidiary has accumulated losses, for tax purposes, as of June 30, 2021, in the amount of approximately $ 129,286 , which may be carried
forward and offset against taxable business income and business capital gain in the future for an indefinite period.
The
German Subsidiary has accumulated losses, for tax purposes, as of June 30, 2021, in the amount of approximately $ 584 , which may be carried
forward and offset against taxable business income and business capital gain in the future for an indefinite period.
F- 30
PLURISTEM
THERAPEUTICS INC. AND ITS SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
U.S.
Dollars in thousands (except share and per share amounts)
NOTE
11: - TAXES ON INCOME (CONT.)
C. Loss
before income taxes
The
components of loss before income taxes are as follows:
Year ended June 30,
2021
2020
Consolidated loss of Pluristem Therapeutics and the Israeli subsidiary
$ 49,432
$ 29,001
Pluristem GmbH
433
151
$ 49,865
$ 29,152
D. Deferred
income taxes:
Deferred
income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets are as follows:
June 30,
2021
2020
Deferred tax assets:
Operating loss carryforwards
$ 57,304
$ 49,034
Research and development credit carryforwards
5,907
5,432
Issuance costs
352
-
Allowances and reserves
336
271
Total deferred tax assets before valuation allowance
63,899
54,737
Valuation allowance
( 63,899 )
( 54,737 )
Net deferred tax asset
$ -
$ -
As
of June 30, 2021 and 2020, the Company has provided full valuation allowances in respect of deferred tax assets resulting from tax loss
carryforwards and other temporary differences, since it has a history of operating losses and due to current uncertainty concerning its
ability to realize these deferred tax assets in the future.
The
Company accounts for its income tax uncertainties in accordance with ASC 740 which clarifies the accounting for uncertainties in
income taxes recognized in a Company’s financial statements and prescribes a recognition threshold and measurement attribute for
the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.
As
of June 30, 2021 and 2020, there were no unrecognized tax benefits that if recognized would affect the annual effective tax rate.
Reconciliation
of taxes at the federal statutory rate to Company’s provision for income taxes:
In
2021 and 2020, the main reconciling item of the statutory tax rate of the Company ( 21 % to 23 %) to the effective tax rate ( 0 %) is tax
loss carryforwards, share-based compensation and other deferred tax assets for which a full valuation allowance was provided.
F- 31
Item
9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.