NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
1.
Organization, Basis of Presentation and Liquidity
General
– Lineage Cell Therapeutics, Inc. (“Lineage”) is a clinical-stage biotechnology company developing novel
cell therapies for unmet medical needs. Lineage’s focus is to develop therapies for degenerative retinal diseases, neurological
conditions associated with demyelination, and aiding the body in detecting and combating cancer. Specifically, Lineage is testing
therapies to treat dry age-related macular degeneration, spinal cord injuries, and non-small cell lung cancer. Lineage’s
programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. From
this platform, Lineage develops and manufactures specialized, terminally or functionally differentiated human cells
from its pluripotent and progenitor cell starting materials. These differentiated cells are transplanted into a patient either
to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury, or administered
as a means of helping the body mount an effective immune response to cancer.
Lineage
has three allogeneic, or “off-the-shelf,” cell therapy programs in clinical development:
|
●
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OpRegen®,
a retinal pigment epithelium cell replacement therapy currently in a Phase 1/2a multicenter clinical trial for the treatment
of advanced dry age-related macular degeneration (“AMD”) with geographic atrophy. There currently are no therapies
approved by the U.S. Food and Drug Administration (“FDA”) for dry AMD, which accounts for approximately 85-90%
of all AMD cases and is the leading cause of blindness in people over the age of 60.
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|
|
|
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●
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OPC1,
an oligodendrocyte progenitor cell therapy currently in a Phase 1/2a multicenter clinical trial for acute spinal cord injuries
(“SCI”). This clinical trial has been partially funded by the California Institute for Regenerative Medicine.
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|
|
|
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●
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VAC2,
cancer immunotherapy of antigen-presenting dendritic cells currently in a Phase 1 clinical trial in non-small cell lung cancer.
This clinical trial is being funded and conducted by Cancer Research UK, the world’s largest independent cancer research
charity.
|
In
addition to seeking to create value for shareholders by developing product candidates and other technologies through our clinical
development programs, we also seek to create value from our technologies through partnering and strategic transactions. We founded
two companies that later became publicly traded companies: OncoCyte Corporation (“OncoCyte”) and AgeX Therapeutics,
Inc. (“AgeX”).
During
the year ended December 31, 2020, we received approximately $12.6 million in gross proceeds in connection with our sale of shares
of OncoCyte and AgeX. In August 2020, we also received $24.6 million from Juvenescence Limited (“Juvenescence”), representing
principal and accrued interest under a promissory note we received in connection with our sale of AgeX shares to Juvenescence in
August 2018.
We
no longer hold any common stock in AgeX. The value of our OncoCyte holdings as of March 5, 2021, was approximately $4.2
million, based on the closing price of its common stock on that date.
Though
our principal focus is on advancing our three cell therapy programs currently in clinical development, we may seek to create additional
value through corporate transactions, as we have in the past, or by initiating new programs using our protocols or with new protocols
and cell lines.
Asterias
Merger
On
November 7, 2018, Lineage, Asterias Biotherapeutics, Inc. (“Asterias”) and Patrick Merger Sub, Inc., a wholly owned
subsidiary of Lineage, entered into an Agreement and Plan of Merger (the “Merger Agreement”) whereby Lineage agreed
to acquire all of the outstanding common stock of Asterias in a stock-for-stock transaction (the “Asterias Merger”).
On
March 7, 2019, the shareholders of each of Lineage and Asterias approved the Merger Agreement. Prior to the Asterias Merger, Lineage
owned approximately 38% of Asterias’ issued and outstanding common stock and accounted for Asterias as an equity method
investment.
On
March 8, 2019, the Asterias Merger closed with Asterias surviving as a wholly owned subsidiary of Lineage. The former stockholders
of Asterias (other than Lineage) received 0.71 common shares of Lineage for every share of Asterias common stock they owned. Lineage
issued 24,695,898 common shares, including 58,085 shares issued in respect of restricted stock units issued by Asterias that immediately
vested in connection with the closing of the Asterias Merger. The aggregate dollar value of such shares, based on the closing
price of Lineage common shares on March 8, 2019, was $32.4 million. Lineage also assumed warrants to purchase shares of Asterias
common stock.
The
Asterias Merger has been accounted for using the acquisition method of accounting in accordance with Accounting Standards Codification
(“ASC”) Topic 805, Business Combinations, which requires, among other things, that the assets and liabilities
assumed be recognized at their fair values as of the acquisition date.
See
Note 3 for a full discussion of the Asterias Merger.
Investment
in OncoCyte
Lineage
has significant equity holdings in OncoCyte, which Lineage founded and, in the past, was a majority-owned consolidated subsidiary
until February 17, 2017, when Lineage deconsolidated OncoCyte’s financial statements. OncoCyte is focused on developing
and commercializing laboratory-developed tests to serve unmet medical needs across the cancer care continuum. As of December 31,
2020, Lineage owned approximately 3.6 million shares of OncoCyte common stock, or 5.4% of its outstanding shares (see Note 4).
Use
of estimates
The
preparation of consolidated financial statements in conformity with accounting principles generally accepted in the U.S. (“GAAP”)
requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues
and expenses during the reporting period with consideration given to materiality. Significant estimates and assumptions which
are subject to significant judgment include those related to going concern assessment of consolidated financial statements, useful
lives associated with long-lived assets, including evaluation of asset impairment, allowances for uncollectible accounts receivables,
loss contingencies, deferred income taxes and tax reserves, including valuation allowances related to deferred income taxes, and
assumptions used to value stock-based awards, debt or other equity instruments. Actual results could differ materially from those
estimates.
Principles
of consolidation
Lineage’s
consolidated financial statements include the accounts of its subsidiaries. The following table reflects Lineage’s ownership,
directly or through one or more subsidiaries, of the outstanding shares of its operating subsidiaries as of December 31, 2020.
Schedule of Lineage's Ownership of Outstanding Shares of its Subsidiaries
Subsidiary
|
|
Field of Business
|
|
Lineage Ownership
|
|
|
Country
|
Asterias BioTherapeutics, Inc.
|
|
Cell therapy clinical development programs in spinal cord injury and oncology
|
|
|
100
|
%
|
|
USA
|
Cell Cure Neurosciences Ltd (“Cell Cure”)
|
|
Development and manufacturing of Lineage’s cell replacement platform technology
|
|
|
99
|
%(1)
|
|
Israel
|
ES Cell International Pte. Ltd. (“ESI”)
|
|
Stem cell products for research, including clinical grade cell lines produced under cGMP
|
|
|
100
|
%
|
|
Singapore
|
OrthoCyte Corporation (“OrthoCyte”)
|
|
Developing bone grafting products for orthopedic diseases and injuries
|
|
|
99.8
|
%
|
|
USA
|
(1)
|
Includes
shares owned by Lineage and ESI
|
All
material intercompany accounts and transactions have been eliminated in consolidation. As of December 31, 2020, Lineage consolidated
its direct and indirect wholly owned or majority-owned subsidiaries because Lineage has the ability to control their operating
and financial decisions and policies through its ownership, and the noncontrolling interest is reflected as a separate element
of shareholders’ equity on Lineage’s consolidated balance sheets.
Liquidity
Since
inception, Lineage has incurred significant operating losses and has funded its operations primarily through sale of common stock
of AgeX and OncoCyte, both former subsidiaries, sale of common stock of Hadasit Bio-Holdings (“HBL”), receipt of research
grants, royalties from product sales, license revenues, sales of research products and issuance of equity securities.
On
May 1, 2020, Lineage entered into a Controlled Equity OfferingSM Sales Agreement (the “Sales Agreement”)
with Cantor Fitzgerald & Co., as sales agent (“Cantor Fitzgerald”), pursuant to which Lineage may, but is not
obligated to, raise up to $25.0
million through the sale of common shares
(“ATM Shares”) from time to time in at-the-market transactions under the Sales Agreement. As of December 31, 2020,
Lineage raised $5.1
million in gross proceeds under
the Sales Agreement (which excludes $0.3 million in cash in transit related to 2020 sales that settled in 2021) and during
the first quarter through March 5, 2021, Lineage raised $19.9
million in gross proceeds under
the Sales Agreement (which includes $0.3 million in cash in transit related to 2020 sales that settled in 2021). On March
5, 2021, Lineage filed a prospectus supplement with the Securities and Exchange Commission (the “SEC”) in connection
with the offer and sale of an additional $25
million of ATM Shares.
At
December 31, 2020, Lineage had an accumulated deficit of approximately $294.1 million, working capital of $36.2 million and shareholders’
equity of $95.1 million. Lineage has evaluated its projected cash flows and believes that its $41.6 million of cash, cash equivalents
and marketable equity securities are sufficient to fund Lineage’s planned operations for at least the next twelve months
from the issuance date of the condensed consolidated financial statements included herein. If Lineage needs near term working
capital or liquidity to supplement its cash and cash equivalents for its operations, Lineage may sell some, or all, of its marketable
equity securities, as necessary.
On
March 8, 2019, Asterias became Lineage’s wholly owned subsidiary, and Lineage began consolidating Asterias’ operations
and results with its operations and results (see Note 3). Lineage has made extensive reductions in headcount and reduced non-clinical
related spend, in each case, as compared to Asterias’ operations before the Asterias Merger.
Lineage’s
projected cash flows are subject to various risks and uncertainties, and the unavailability or inadequacy of financing to meet
future capital needs could force Lineage to modify, curtail, delay, or suspend some or all aspects of its planned operations.
Lineage’s determination as to when it will seek new financing and the amount of financing that it will need will be based
on Lineage’s evaluation of the progress it makes in its research and development programs, any changes to the scope and
focus of those programs, any changes in grant funding for certain of those programs, and projection of future costs, revenues,
and rates of expenditure. Lineage’s ability to raise additional funds may be adversely impacted by deteriorating global
economic conditions and the disruptions to and volatility in the credit and financial markets in the United States and worldwide
resulting from the ongoing COVID-19 pandemic. Lineage may be required to delay, postpone, or cancel clinical trials or limit the
number of clinical trial sites, unless it is able to obtain adequate financing. In addition, Lineage has incurred significant
costs in connection with the acquisition of Asterias and with integrating its operations. Lineage may incur additional costs to
maintain employee morale and to retain key employees. Lineage cannot assure that adequate financing will be available on favorable
terms, if at all. Sales of additional equity securities by Lineage or its subsidiaries and affiliates could result in the dilution
of the interests of current shareholders.
2.
Summary of Significant Accounting Policies
Business
Combinations – Lineage accounts for business combinations, such as the Asterias Merger completed in March 2019, in accordance
with ASC Topic 805, which requires the purchase price to be measured at fair value. When the purchase consideration consists entirely
of Lineage common shares, Lineage calculates the purchase price by determining the fair value, as of the acquisition date, of
shares issued in connection with the closing of the acquisition. Lineage recognizes estimated fair values of the tangible assets
and intangible assets acquired, including in-process research and development (“IPR&D”), and liabilities assumed
as of the acquisition date, and records as goodwill any amount of the fair value of the tangible and intangible assets acquired
and liabilities assumed in excess of the purchase price.
Marketable
Equity Securities – Lineage accounts for the shares it holds in OncoCyte and HBL (and AgeX previously) as marketable
equity securities in accordance with ASC 320-10-25, Investments – Debt and Equity Securities, as amended by Accounting
Standards Update (“ASU”) 2016-01, Financial Instruments–Overall: Recognition and Measurement of Financial
Assets and Financial Liabilities, further discussed below.
The
OncoCyte and AgeX shares have readily determinable fair values quoted on the NYSE American under trading symbols “OCX”
and “AGE”. The HBL shares have a readily determinable fair value quoted on the Tel Aviv Stock Exchange (“TASE”)
under trading symbol “HDST” where share prices are denominated in New Israeli Shekels (NIS).
Prior
to September 11, 2019, Lineage accounted for its OncoCyte shares held at fair value, using the equity method of accounting. On
September 11, 2019, Lineage’s ownership percentage decreased from 24% to 16% when it sold 4.0 million shares of OncoCyte
common stock. Accordingly, as the ownership percentage was reduced to less than 20%, Lineage is no longer considered to exercise
significant influence over OncoCyte and is now accounting for its OncoCyte holdings as marketable equity securities. Prior to
the Asterias Merger completed on March 8, 2019, Lineage accounted for its Asterias shares held at fair value, using the equity
method of accounting.
Revenue
Recognition – Lineage recognizes revenue in accordance with Financial Accounting Standards Board (“FASB”)
Accounting Standards Update (“ASU”) ASU 2014-09, Revenues from Contracts with Customers (Topic 606), and in
a manner that depicts the transfer of control of a product or a service to a customer and reflects the amount of the consideration
it is entitled to receive in exchange for such product or service. In doing so, Lineage follows a five-step approach: (i) identify
the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price;
(iv) allocate the transaction price to the performance obligations; and (v) recognize revenue when (or as) the customer obtains
control of the product or service. Lineage considers the terms of a contract and all relevant facts and circumstances when applying
the revenue recognition standard. Lineage applies the revenue recognition standard, including the use of any practical expedients,
consistently to contracts with similar characteristics and in similar circumstances.
Lineage’s
largest source of revenue is currently related to government grants. In applying the provisions of ASU 2014-09, Lineage has determined
that government grants are out of the scope of ASU 2014-09 because the government entities do not meet the definition of a “customer,”
as defined by ASU 2014-09, as there is not considered to be a transfer of control of good or services to the government entities
funding the grant. Lineage has, and will continue to, account for grants received to perform research and development services
in accordance with ASC 730-20, Research and Development Arrangements, which requires an assessment, at the inception of
the grant, of whether the grant is a liability or a contract to perform research and development services for others. If Lineage
or a subsidiary receiving the grant is obligated to repay the grant funds to the grantor regardless of the outcome of the research
and development activities, then Lineage is required to estimate and recognize that liability. Alternatively, if Lineage or a
subsidiary receiving the grant is not required to repay, or if it is required to repay the grant funds only if the research and
development activities are successful, then the grant agreement is accounted for as a contract to perform research and development
services for others, in which case, grant revenue is recognized when the related research and development expenses are incurred
(see Note 14).
Deferred
grant revenues represent grant funds received from the governmental funding agencies for which the allowable expenses have not
yet been incurred as of the balance sheet date reported. As of December 31, 2020, deferred grant revenue was $193,000.
Basic
and diluted net income (loss) per share attributable to common shareholders – Basic earnings per share is calculated
by dividing net income or loss attributable to Lineage common shareholders by the weighted average number of common shares outstanding,
net of unvested restricted stock or restricted stock units, subject to repurchase by Lineage, if any, during the period. Diluted
earnings per share is calculated by dividing the net income or loss attributable to Lineage common shareholders by the weighted
average number of common shares outstanding, adjusted for the effects of potentially dilutive common shares issuable under outstanding
stock options and warrants, using the treasury-stock method, convertible preferred stock, if any, using the if-converted method,
and treasury stock held by subsidiaries, if any.
For
the years ended December 31, 2020 and 2019, respectively, Lineage reported a net loss attributable to common shareholders, and
therefore, all potentially dilutive common shares were considered antidilutive for those periods.
The
following common share equivalents were excluded from the computation of diluted net income (loss) per common share for the periods
presented because including them would have been antidilutive (in thousands):
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share
|
|
Years
Ended
December
31,
|
|
|
|
2020
|
|
|
2019
|
|
Stock options
|
|
|
16,215
|
|
|
|
15,060
|
|
Lineage Warrants (1)
(Note 3)
|
|
|
1,090
|
|
|
|
1,090
|
|
Restricted stock units
|
|
|
93
|
|
|
|
166
|
|
(1)
|
Although
the Lineage Warrants are classified as liabilities, these warrants are considered for dilutive earnings per share calculations
in accordance with ASC 260, Earnings Per Share, and determined to be anti-dilutive for the period presented.
|
Restricted
Cash – In accordance with ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash, Lineage explains
the change during the year in the total of cash, cash equivalents and restricted cash, and includes restricted cash with
cash and cash equivalents when reconciling the beginning-of-year and end-of-year total amounts shown on the condensed
consolidated statements of cash flows.
Lineage
has several certificates of deposit as required under our facility leases and credit card program. Lineage is restricted from
using this cash for working capital purposes. At December 31, 2020, Lineage maintains $420,000 pursuant to the Cell Cure Leases,
$100,000 pursuant to its credit card program and $78,000 pursuant to the Alameda Lease. Amounts related to the Cell Cure Leases
and credit card program are recorded in deposits and other long-term assets and the amount related to the Alameda Lease is recorded
in prepaid expenses and other current assets, as this certificate of deposit is expected to be released within the first quarter
of 2021.
The
following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated
balance sheet dates that comprise the total of the same such amounts shown in the condensed consolidated statements of cash flows
for all periods presented herein (in thousands):
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash
|
|
December
31,
2020
|
|
|
December
31,
2019
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
32,585
|
|
|
$
|
9,497
|
|
Restricted cash included in deposits and other long-term assets (see Note 14)
|
|
|
520
|
|
|
|
599
|
|
Restricted cash included in prepaid expenses and other current assets
(see Note 14)
|
|
|
78
|
|
|
|
-
|
|
Total cash, cash equivalents, and restricted cash as shown in the condensed
consolidated statements of cash flows
|
|
$
|
33,183
|
|
|
$
|
10,096
|
|
Lease
accounting and impact of adoption of the new lease standard – On January 1, 2019, Lineage adopted ASU 2016-02, Leases
(Topic 842, “ASC 842”) and its subsequent amendments affecting Lineage: (i) ASU 2018-10, Codification Improvements
to Topic 842, Leases; and (ii) ASU 2018-11, Leases (Topic 842): Targeted improvements, using the modified retrospective
method.
Lineage
management determines if an arrangement is a lease at inception. Leases are classified as either financing or operating, with
classification affecting the pattern of expense recognition in the consolidated statements of operations. When determining whether
a lease is a finance lease or an operating lease, ASC 842 does not specifically define criteria to determine “major part
of remaining economic life of the underlying asset” and “substantially all of the fair value of the underlying asset.”
For lease classification determination, Lineage continues to use: (i) greater than or equal to 75% to determine whether the lease
term is a major part of the remaining economic life of the underlying asset; and (ii) greater than or equal to 90% to determine
whether the present value of the sum of lease payments is substantially all of the fair value of the underlying asset. Under the
available practical expedients, Lineage accounts for the lease and non-lease components as a single lease component. Lineage recognizes
right-of-use (“ROU”) assets and lease liabilities for leases with terms greater than twelve months in the condensed
consolidated balance sheet.
ROU
assets represent Lineage’s right to use an underlying asset during the lease term and lease liabilities represent Lineage’s
obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement
date based on the present value of lease payments over the lease term. As most of Lineage’s leases do not provide an implicit
rate, Lineage uses its incremental borrowing rate based on the information available at commencement date in determining the present
value of lease payments. Lineage uses the implicit rate when readily determinable. The operating lease ROU asset also includes
any lease payments made and excludes lease incentives. Lineage’s lease terms may include options to extend or terminate
the lease when it is reasonably certain that Lineage will exercise that option. Lease expense for lease payments is recognized
on a straight-line basis over the lease term.
Operating
leases are included as right-of-use assets in property and equipment (see Note 6), and ROU lease liabilities, current and long-term,
in the condensed consolidated balance sheets. Financing leases are included in property and equipment, and in financing lease
liabilities, current and long-term, in Lineage’s condensed consolidated balance sheets.
In
connection with the adoption on ASC 842 on January 1, 2019, Lineage derecognized net book value of leasehold improvements and
corresponding lease liabilities of $1.9 million and $2.0 million, respectively, which was the carrying value of certain operating
leases as of December 31, 2018, included in property and equipment and lease liabilities, respectively, recorded pursuant to build
to suit lease accounting under the previous ASC 840 lease standard. The derecognition of these amounts from the superseded ASC
840 lease standard was offset by a cumulative effect adjustment of $0.1 million as a reduction of Lineage’s accumulated
deficit on January 1, 2019. These build to suit leases were primarily related to Lineage’s prior leases in Alameda, California
and Cell Cure’s leases in Jerusalem, Israel (See Note 14). ASC 842 requires build to suit leases recognized on Lineage’s
consolidated balance sheets as of December 31, 2018 to be derecognized upon the adoption of the new lease standard and be recognized
in accordance with the new standard on January 1, 2019.
The
adoption of ASC 842 had a material impact in Lineage’s consolidated balance sheets, with the most significant impact resulting
from the recognition of ROU assets and lease liabilities for operating leases with remaining terms greater than twelve months
on the adoption date. Lineage’s accounting for financing leases (previously referred to as “capital leases”)
remained substantially unchanged (see Note 14).
Goodwill
and IPR&D – Goodwill is calculated as the difference between the acquisition date fair value of the consideration
transferred and the values assigned to the assets acquired and liabilities assumed. Goodwill is not amortized but is tested for
impairment at least annually, or more frequently if circumstances indicate potential impairment. IPR&D assets are indefinite-lived
intangible assets until the completion or abandonment of the associated research and development (“R&D”) efforts.
Once the R&D efforts are completed or abandoned, the IPR&D will either be amortized over the asset life as a finite-lived
intangible asset or be impaired, respectively, in accordance with ASC 350, Intangibles – Goodwill and Other. In accordance
with ASC 350, goodwill and acquired IPR&D are determined to have indefinite lives and, therefore, are not amortized. Instead,
they are tested for impairment at least annually and between annual tests if Lineage becomes aware of an event or a change in
circumstances that would indicate the asset may be impaired.
Going
concern assessment – Lineage assesses going concern uncertainty for its consolidated financial statements to determine
if Lineage has sufficient cash and cash equivalents on hand and working capital to operate for a period of at least one year from
the date the consolidated financial statements are issued or are available to be issued, which is referred to as the “look-forward
period” as defined by FASB’s ASU No. 2014-15. As part of this assessment, based on conditions that are known and reasonably
knowable to Lineage, Lineage will consider various scenarios, forecasts, projections, and estimates, and Lineage will make certain
key assumptions, including the timing and nature of projected cash expenditures or programs, and its ability to delay or curtail
those expenditures or programs, if necessary, among other factors. Based on this assessment, as necessary or applicable, Lineage
makes certain assumptions concerning its ability to curtail or delay research and development programs and expenditures within
the look-forward period in accordance with ASU No. 2014-15.
Cash
and cash equivalents – Lineage considers all highly liquid investments purchased with an original maturity of three
months or less to be cash equivalents. As of December 31, 2020 and 2019, Lineage had $28.8 million and $6.6 million in money market
funds, respectively, considered to be cash equivalents.
Concentrations
of credit risk and significant sources of supply – Financial instruments that potentially subject Lineage to significant
concentrations of credit risk consist primarily of cash and cash equivalents. Lineage limits the amount of credit exposure of
cash balances by maintaining its accounts in high credit quality financial institutions. Cash equivalent deposits with financial
institutions may occasionally exceed the limits of insurance on bank deposits; however, Lineage has not experienced any losses
on such accounts.
Lineage
relies on single-source, third-party suppliers for a few key components of our product candidates. If these single-source, third-party
suppliers are unable to continue providing a key component, the initiation or progress of any clinical studies of its product
candidates may be impeded.
Property
and equipment, net – Property and equipment is stated at cost and is being depreciated using the straight-line method
over their estimated useful lives ranging from 3 to 10 years. Leasehold improvements are amortized over the shorter of the useful
life or the lease term. (See Note 6).
Long-lived
intangible assets – Long-lived intangible assets, consisting primarily of acquired patents, patent applications, and
licenses to use certain patents are stated at acquired cost, less accumulated amortization. Amortization expense is computed using
the straight-line method over the estimated useful lives of the assets, generally over 5 to 10 years.
Impairment
of long-lived assets – Long-lived assets, including long-lived intangible assets, are reviewed annually for impairment
and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be fully recoverable. If
an impairment indicator is present, Lineage evaluates recoverability by a comparison of the carrying amount of the assets to future
undiscounted net cash flows expected to be generated by the assets. If the assets are impaired, the impairment recognized is measured
by the amount by which the carrying amount exceeds the estimated fair value of the assets.
Accounting
for warrants – Lineage determines the accounting classification of warrants that it or its subsidiaries issue, as either
liability or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480-10, Accounting
for Certain Financial Instruments with Characteristics of both Liabilities and Equity, and then in accordance with ASC 815-40,
Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock. Under
ASC 480, warrants are considered liability classified if the warrants are mandatorily redeemable, obligate the issuer to settle
the warrants or the underlying shares by paying cash or other assets, or warrants that must or may require settlement by issuing
variable number of shares. If warrants do not meet liability classification under ASC 480-10, Lineage assesses the requirements
under ASC 815-40, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities
recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature.
If the warrants do not require liability classification under ASC 815-40, in order to conclude equity classification, Lineage
assesses whether the warrants are indexed to its common stock or its subsidiary’s common stock, as applicable, and whether
the warrants are classified as equity under ASC 815-40 or other applicable GAAP. After all relevant assessments are made, Lineage
concludes whether the warrants are classified as liability or equity. Liability classified warrants are required to be accounted
for at fair value both on the date of issuance and on subsequent accounting period ending dates, with all changes in fair value
after the issuance date recorded in the consolidated statements of operations as a gain or loss. Equity classified warrants are
accounted for at fair value on the issuance date with no changes in fair value recognized subsequent to the issuance date. In
2017, Cell Cure issued certain liability classified warrants (see Note 11) and in 2019, Lineage assumed certain warrants
in connection with the closing of the Asterias Merger (see Note 3).
Transactions
with noncontrolling interests of subsidiaries - Lineage accounts for a change in ownership interests in its subsidiaries that
does not result in a change of control of the subsidiary by Lineage under the provisions of ASC 810-10-45-23,
Consolidation – Other Presentation Matters, which prescribes the accounting for changes in ownership interest
that do not result in a change in control of the subsidiary, as defined by GAAP, before and after the transaction. Under
this guidance, changes in a controlling shareholder’s ownership interest that do not result in a change of control, as defined
by GAAP, in the subsidiary are accounted for as equity transactions. Thus, if the controlling shareholder retains control, no
gain or loss is recognized in the statements of operations of the controlling shareholder. Similarly, the controlling shareholder
will not record any additional acquisition adjustments to reflect its subsequent purchases of additional shares in the subsidiary
if there is no change of control. Only a proportional and immediate transfer of carrying value between the controlling and the
noncontrolling shareholders occurs based on the respective ownership percentages.
Research
and development expenses - Research and development expenses consist of costs incurred for company-sponsored, collaborative
and contracted research and development activities. These costs include direct and research-related overhead expenses including
compensation and related benefits, stock-based compensation, consulting fees, research and laboratory fees, rent of research facilities,
amortization of intangible assets, and license fees paid to third parties to acquire patents or licenses to use patents and other
technology. Research and development are expensed as incurred. Research and development expenses incurred and reimbursed by grants
from third parties approximate the grant income recognized in the consolidated statements of operations.
General
and administrative expenses - General and administrative expenses consist of compensation and related benefits, including
stock-based compensation, for executive and corporate personnel; professional and consulting fees; and allocated overhead such
as facilities and equipment rent and maintenance, insurance costs allocated to general and administrative expenses, costs of patent
applications, prosecution and maintenance, stock exchange-related costs, depreciation expense, marketing costs, and other miscellaneous
expenses which are allocated to general and administrative expense.
Foreign
currency translation adjustments and other comprehensive income or loss - In countries in which Lineage operates where the
functional currency is other than the U.S. dollar, assets and liabilities are translated using published exchange rates in effect
at the consolidated balance sheet date. Revenues and expenses and cash flows are translated using an approximate weighted average
exchange rate for the period. Resulting foreign currency translation adjustments are recorded as other comprehensive income or
loss, net of tax, in the consolidated statements of comprehensive income or loss and included as a component of accumulated other
comprehensive income or loss on the consolidated balance sheets. Foreign currency translation adjustments are primarily attributable
to Cell Cure and ESI, Lineage’s consolidated foreign subsidiaries. For the years ended December 31, 2020 and 2019, comprehensive
loss includes foreign currency translation adjustments, net of tax, of $3.0 million and $2.1 million, respectively.
Foreign
currency transaction gains and losses - For transactions denominated in other than the functional currency of Lineage or its
subsidiaries, Lineage recognizes transaction gains and losses in the consolidated statements of operations and classifies the
gain or loss based on the nature of the item that generated it. The majority of Lineage’s foreign currency transaction gains
and losses are generated by Cell Cure’s intercompany debt due to Lineage, which are U.S. dollar-denominated, while Cell
Cure’s functional currency is the Israeli New Shekel (“ILS”). At each balance sheet date, Lineage remeasures
the intercompany debt using the current exchange rate at that date pursuant to ASC 830, Foreign Currency Matters. These
foreign currency remeasurement gains and losses are included in other income and expenses, net.
Income
taxes - Lineage accounts for income taxes in accordance with ASC 740, Income Taxes, which prescribe the use of the
asset and liability method, whereby deferred tax asset or liability account balances are calculated at the balance sheet date
using current tax laws and rates in effect. Valuation allowances are established when necessary to reduce deferred tax assets
when it is more likely than not that a portion or all of the deferred tax assets will not be realized. ASC 740 guidance also prescribes
a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken
or expected to be taken in a tax return. For benefits to be recognized, a tax position must be more-likely-than-not sustainable
upon examination by taxing authorities. Lineage files a U.S. federal income tax return as well as various state and foreign income
tax returns. Lineage’s judgments regarding future taxable income may change over time due to changes in market conditions,
changes in tax laws, tax planning strategies or other factors. If Lineage assumptions, and consequently the estimates, change
in the future with respect to Lineage’s own deferred tax assets and liabilities, the valuation allowance may be increased
or decreased, which may have a material impact on Lineage’s consolidated financial statements. Lineage recognizes accrued
interest and penalties related to unrecognized tax benefits, if any, as income tax expense; however, no amounts were accrued
for the payment of interest and penalties as of December 31, 2020 and 2019.
Stock-based
compensation - Lineage follows accounting standards governing share-based payments in accordance with ASC 718, Compensation
– Stock Compensation, which require the measurement and recognition of compensation expense for all share-based payment
awards made to directors and employees, including employee stock options, based on estimated fair values. Lineage utilizes the
Black-Scholes option pricing model for valuing share-based payment awards. Lineage’s determination of fair value of share-based
payment awards on the date of grant using that option-pricing model is affected by Lineage’s stock price as well as by assumptions
regarding a number of complex and subjective variables. These variables include, but are not limited to, expected stock price
volatility over the term of the awards, and the expected term of options granted, which is derived using the simplified method,
which is an average of the contractual term of the option and its vesting period, as we do not have sufficient historical exercise
data. The risk-free rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes
with maturities similar to the expected term of the awards. Forfeitures are accounted for as they occur.
Although
the fair value of employee stock options is determined in accordance with FASB guidance, changes in the assumptions can materially
affect the estimated value and therefore the amount of compensation expense recognized in the consolidated financial statements.
Royalties
from product sales and license fees - Lineage’s performance obligations in agreements with certain customers is to provide
a license to allow customers to make, import and sell company licensed products or methods for preclinical studies and commercial
use. Customers pay a combination of a license issue fee paid up front and a sales-based royalty, if any, in some cases with yearly
minimums. The transaction price is deemed to be the license issue fee stated in the contract. The license offered by Lineage is
a functional license with significant standalone functionality and provides customers with the right to use Lineage’s intellectual
property. This allows Lineage to recognize revenue on the license issue fee at a point in time at the beginning of the contract,
which is when the customer begins to have use of the license. Variable consideration related to sales-based royalties is recognized
only when (or as) the later of one or more of the following events occur: (a) a sale or usage occurs, or (b) the performance obligation
to which some, or all, of the sales-based or usage-based royalty that has been allocated and has been satisfied or partially satisfied.
Due to the contract termination clauses, Lineage does not expect to receive all of the minimum royalty payments throughout the
term of the agreements. Therefore, Lineage fully constrains recognition of the minimum royalty payments as revenues until its
customers are obligated to pay, which is generally within 60 days prior to the beginning of each year the minimum royalty payments
are due.
Grant
revenues - In applying the provisions of Topic 606, Lineage has determined that government grants are out of the scope of
Topic 606 because the government entities do not meet the definition of a “customer”, as defined by Topic 606, as
there is not considered to be a transfer of control of good or services to the government entities funding the grant. Lineage
has, and will continue to, account for grants received to perform research and development services in accordance with ASC 730-20,
Research and Development Arrangements, which requires an assessment, at the inception of the grant, of whether the grant
is a liability or a contract to perform research and development services for others. If Lineage or a subsidiary receiving the
grant is obligated to repay the grant funds to the grantor regardless of the outcome of the research and development activities,
then Lineage is required to estimate and recognize that liability. Alternatively, if Lineage or a subsidiary receiving the grant
is not required to repay, or if it is required to repay the grant funds only if the research and development activities are successful,
then the grant agreement is accounted for as a contract to perform research and development services for others, in which case,
grant revenue is recognized when the related research and development expenses are incurred.
Deferred
grant revenues represent grant funds received from the governmental funding agencies for which the allowable expenses have not
yet been incurred as of the balance sheet date reported.
Revenue
Recognition by Source and Geography - Revenues are recognized when control of the promised goods or services is transferred
to customers, or in the case of governmental entities funding a grant, when allowable expenses are incurred, in an amount that
reflects the consideration Lineage or a subsidiary, depending on which company has the customer or the grant, expects to be entitled
to in exchange for those goods or services.
The
following table presents Lineage’s consolidated revenues disaggregated by source (in thousands).
Schedule of Disaggregated Revenues
|
|
Year Ended December 31,
|
|
|
|
2020
|
|
|
2019
|
|
REVENUES:
|
|
|
|
|
|
|
Grant revenue
|
|
$
|
1,053
|
|
|
$
|
2,037
|
|
Royalties from product sales and license fees
|
|
|
773
|
|
|
|
1,221
|
|
Sale of research products and services
|
|
|
-
|
|
|
|
257
|
|
Total revenues
|
|
$
|
1,826
|
|
|
$
|
3,515
|
|
The
following table presents consolidated revenues, disaggregated by geography, based on the billing addresses of customers, or in
the case of grant revenues, based on where the governmental entities that fund the grant are located (in thousands).
Schedule of Revenues Disaggregated
by Geography
|
|
Year Ended December 31,
|
|
|
|
2020
|
|
|
2019
|
|
REVENUES:
|
|
|
|
|
|
|
United States
|
|
$
|
1,160
|
|
|
$
|
2,092
|
|
Foreign (1)
|
|
|
666
|
|
|
|
1,423
|
|
Total revenues
|
|
$
|
1,826
|
|
|
$
|
3,515
|
|
(1)
|
Foreign
revenues are primarily generated from grants in Israel.
|
Recently
Adopted Accounting Pronouncements
In
August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure
Requirements for Fair Value Measurement, which modifies certain disclosure requirements for reporting fair value measurements.
ASU 2018-13 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Lineage
adopted this standard on January 1, 2020 and it did not have a significant impact on our consolidated financial statements.
Recently
Issued Accounting Pronouncements Not Yet Adopted - The following accounting standards, which are not yet effective, are presently
being evaluated by Lineage to determine the impact that they might have on its consolidated financial statements.
In
December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes. The ASU enhances and simplifies
various aspects of the income tax accounting guidance in ASC 740 and removes certain exceptions for recognizing deferred taxes
for investments, performing intraperiod allocation and calculating income taxes in interim periods. The ASU also adds guidance
to reduce complexity in certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of
a consolidated group. This ASU is effective for fiscal years beginning after December 15, 2020, and interim periods within those
fiscal years with early adoption permitted. Lineage adopted this standard as of January 1, 2021 and it is not expected to have
a material impact on the consolidated financial statements.
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses
on Financial Instruments. ASU 2016-13 is intended to provide financial statement users with more decision-useful information
about the expected credit losses on financial instruments and other commitments and requires consideration of a broader range
of reasonable and supportable information to inform credit loss estimates. ASU 2016-13 is effective for Lineage beginning January
1, 2023. Lineage has not yet completed its assessment of the impact of the new standard on its consolidated financial statements.
3.
Asterias Merger
On
March 8, 2019, the Asterias Merger closed with Asterias surviving as a wholly owned subsidiary of Lineage. The former stockholders
of Asterias (other than Lineage) received 0.71 common shares of Lineage (the “Merger Consideration”) for every share
of Asterias common stock they owned (the “Merger Exchange Ratio”). Lineage issued 24,695,898 common shares, including
58,085 shares issued in respect of restricted stock units issued by Asterias that immediately vested in connection with the closing
of the Asterias Merger. The fair value of such shares, based on the closing price of Lineage common shares on March 8, 2019, was
$32.4 million.
In
connection with the closing of the Asterias Merger, Lineage assumed outstanding warrants to purchase shares of Asterias common
stock, as further discussed below and in Note 11, and assumed sponsorship of the Asterias 2013 Equity Incentive Plan (see
Note 12). All stock options to purchase shares of Asterias common stock outstanding immediately prior to the closing of
the Asterias Merger were canceled at the closing for no consideration.
As
of December 31, 2019, the assets and liabilities of Asterias have been included in the consolidated balance sheet of Lineage.
The results of operations of Asterias from March 8, 2019 through December 31, 2019 have been included in the consolidated statement
of operations of Lineage for the year ended December 31, 2019.
Calculation
of the purchase price
The
calculation of the purchase price for the Asterias Merger and the Merger Consideration transferred on March 8, 2019 was as follows
(in thousands, except for share and per share amounts):
Schedule of Merger Consideration Transferred
|
|
Lineage
(38%
ownership
interest)
|
|
|
Shareholders
other
than
Lineage
(approximate
62%
ownership
interest)
|
|
|
Total
|
|
Outstanding Asterias common stock as of March 8, 2019
|
|
|
21,747,569
|
|
|
|
34,783,333
|
(1)
|
|
|
56,530,902
|
(1)
|
Exchange ratio
|
|
|
0.710
|
|
|
|
0.710
|
|
|
|
0.710
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lineage common shares issuable
|
|
|
15,440,774
|
(2)
|
|
|
24,695,898
|
(3)
|
|
|
40,136,672
|
|
Per share price of Lineage common shares as of March 8, 2019
|
|
$
|
1.31
|
|
|
$
|
1.31
|
|
|
$
|
1.31
|
|
Purchase price (in $000s)
|
|
$
|
20,227
|
(2)
|
|
$
|
32,353
|
|
|
$
|
52,580
|
|
(1)
|
Includes
81,810 shares of Asterias restricted stock unit awards that immediately vested on March 8, 2019 and converted into the right
to receive common shares of Lineage based on the Merger Exchange Ratio, resulting in 58,085 common shares of Lineage issued
on March 8, 2019 as part of the Merger Consideration. These restricted stock units were principally attributable to pre-combination
services and included as part of the purchase price in accordance with ASC 805. See Note 12 for Asterias restricted stock
units that vested on the closing of the Asterias Merger attributable to post-combination services that were recorded outside
of the purchase price as an immediate charge to stock-based compensation expense.
|
|
|
(2)
|
Estimated
fair value for Lineage’s previously held 38% ownership interest in Asterias common stock is part of the total purchase
price of Asterias for purposes of the purchase price allocation under ASC 805 and for Lineage’s adjustment of its 38%
interest to fair value at the effective date of the Asterias Merger and immediately preceding the consolidation of Asterias’
results with Lineage. No actual common shares of Lineage were issued to Lineage in connection with the Asterias Merger.
|
|
|
(3)
|
Net
of a de minimis number of fractional shares which were paid in cash.
|
Purchase
price allocation
Lineage
allocated the acquisition consideration to tangible and identifiable intangible assets acquired and liabilities assumed based
on their estimated fair values as of the acquisition date. The fair value of the acquired tangible and identifiable intangible
assets were determined based on inputs that are unobservable and significant to the overall fair value measurement. It is also
based on estimates and assumptions made by management at the time of the acquisition. As such, this was classified as Level 3
fair value hierarchy measurements and disclosures.
The
allocation of the purchase price in the table below is based on our estimates of the fair values of tangible and intangible assets
acquired, including IPR&D, and liabilities assumed as of the acquisition date, with the excess recorded as goodwill (in thousands).
As of December 31, 2019, Lineage had finalized its purchase price allocation.
Schedule of Identifiable Tangible and Intangible Assets Acquired and Liabilities Assumed
Assets acquired:
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
3,117
|
|
Prepaid expenses and other assets, current and noncurrent
|
|
|
660
|
|
Machinery and equipment
|
|
|
308
|
|
Long-lived intangible assets - royalty contracts
|
|
|
650
|
|
Acquired in-process research and development (“IPR&D”)
|
|
|
46,540
|
|
|
|
|
|
|
Total assets acquired
|
|
|
51,275
|
|
Liabilities assumed:
|
|
|
|
|
Accrued liabilities and accounts payable
|
|
|
982
|
|
Liability classified warrants
|
|
|
867
|
|
Deferred license revenue
|
|
|
200
|
|
Long-term deferred income tax liability
|
|
|
10,753
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
12,802
|
|
|
|
|
|
|
Net assets acquired, excluding goodwill (a)
|
|
|
38,473
|
|
|
|
|
|
|
Fair value of Lineage common shares held by Asterias (b)
|
|
|
3,435
|
|
|
|
|
|
|
Total purchase price (c)
|
|
|
52,580
|
|
|
|
|
|
|
Estimated goodwill (c-a-b)
|
|
$
|
10,672
|
|
The
valuation of identifiable intangible assets and their estimated useful lives are as follows (in thousands, except for useful life):
Schedule of Valuation of Identifiable Intangible Assets and Their Estimated Useful Lives
|
|
Preliminary Estimated Asset
Fair Value
|
|
|
Useful
Life
(Years)
|
|
|
|
(in thousands, except for useful life)
|
|
In process research and development (“IPR&D”)
|
|
$
|
46,540
|
|
|
|
n/a
|
|
Royalty contracts
|
|
|
650
|
|
|
|
5
|
|
|
|
$
|
47,190
|
|
|
|
|
|
The
following is a discussion of the valuation methods used to determine the fair value of Asterias’ significant assets and
liabilities in connection with the Asterias Merger:
IPR&D
and Deferred Income Tax Liability - The fair value of identifiable acquired IPR&D intangible assets consisting of $31.7
million pertaining to the OPC1 program that is currently in a Phase 1/2a clinical trial for SCI, which has been partially funded
by the California Institute for Regenerative Medicine and $14.8 million pertaining to the VAC2 program, which is an allogeneic,
or “off-the-shelf,” cancer immunotherapy derived from pluripotent stem cells for which a clinical trial in non-small
cell lung cancer is being funded and sponsored by Cancer Research UK. The identification of these intangible assets are based
on consideration of historical experience and a market participant’s view further discussed below; collectively, OPC1 and
VAC2 are referred to as the “AST-Clinical Programs”. These intangible assets are valued primarily through the use
of a probability weighted discounted cash flow method under the income approach further discussed below. Lineage considered Asterias’
VAC1 program, which is an autologous, or patient-specific, cancer immunotherapy derived from the patient’s own cells, to
have de minimis value due to significant risks, substantial costs and limited opportunities.
Lineage
determined that the estimated aggregate fair value of the AST-Clinical programs was $46.5 million as of the acquisition date using
a probability weighted discounted cash flow method for each respective program. This approach estimates the probability of the
AST-Clinical Programs achieving successful completion of remaining clinical trials and related approvals into the valuation technique.
To
calculate fair value of the AST-Clinical programs under the discounted cash flow method, Lineage used probability-weighted, projected
cash flows discounted at a rate considered appropriate given the significant inherent risks associated with cell therapy development
by clinical-stage companies. Cash flows were calculated based on estimated projections of revenues and expenses related to each
respective program. Cash flows were assumed to extend through a seven-year market exclusivity period for the OPC1 program from
the date of market launch. Revenues from commercialization of the AST-Clinical Programs were based on estimated market potential
for the indication of each program. The resultant cash flows were then discounted to present value using a weighted-average cost
of capital for companies with profiles substantially similar to that of Lineage, which Lineage believes represents the rate that
market participants would use to value the assets. Lineage compensated for the phase of development of the program by applying
a probability factor to its estimation of the expected future cash flows. The projected cash flows were based on significant assumptions,
including the indications in which Lineage will pursue development of the AST-Clinical programs, the time and resources needed
to complete the development and regulatory approval, estimates of revenue and operating profit related to the program considering
its stage of development, the life of the potential commercialized product, market penetration and competition, and risks associated
with achieving commercialization, including delay or failure to obtain regulatory approvals to conduct clinical studies, failure
of clinical studies, delay or failure to obtain required market clearances, and intellectual property litigation.
These
IPR&D assets are indefinite-lived intangible assets until the completion or abandonment of the associated research and development
(“R&D”) efforts. Once the R&D efforts are completed or abandoned, the IPR&D will either be amortized over
the asset life as a finite-lived intangible asset or be impaired, respectively, in accordance with ASC 350, Intangibles - Goodwill
and Other. In accordance with ASC 350, goodwill and acquired IPR&D are determined to have indefinite lives and, therefore,
are not amortized. Instead, they are tested for impairment at least annually and between annual tests if Lineage becomes aware
of an event or a change in circumstances that would indicate the asset may be impaired.
Because
the IPR&D (prior to completion or abandonment of the R&D) is considered an indefinite-lived asset for accounting purposes,
the fair value of the IPR&D on the acquisition date creates a deferred income tax liability (“DTL”) in accordance
with ASC 740, Income Taxes (see Note 13). This DTL is computed using the fair value of the IPR&D assets on the
acquisition date multiplied by Lineage’s federal and state income tax rates. While this DTL would reverse on impairment
or sale or commencement of amortization of the related intangible assets, those events are not anticipated under ASC 740 for purposes
of predicting reversal of a temporary difference to support the realization of deferred tax assets, except for certain deferred
tax assets and credit carryforwards that are also indefinite in nature as of the closing of the Asterias Merger, which may be
considered for reversal under ASC 740 as further discussed in Note 13.
Royalty
contracts – Asterias has certain royalty revenues for “research only use” culture media for preclinical
research applications under certain, specific patent families under contracts which preclude the customers to sell for commercial
use or for clinical trials. These royalty cash flows are generated under certain specific patent families which Asterias previously
acquired from Geron Corporation (“Geron”). Asterias pays Geron a royalty for all royalty revenues received from these
contracts. Because these patents are a subset of the clinical programs discussed above, are expected to continue to generate revenues
for Asterias and are not to be used in the OPC1 or the VAC2 programs, these patents are considered to be separate long-lived intangible
assets under ASC 805. These intangible assets are also valued primarily through the use of the discounted cash flow method under
the income approach, and will be amortized over their useful life, estimated to be 5 years. The discounted cash flow method estimated
the amount of net royalty income that can be expected under the contracts in future years. The amounts were based on observed
historical trends in the growth of these revenue streams, and were estimated to terminate in approximately five years, when the
key patents under these contracts will begin to expire. The resulting cash flows were discounted to the valuation date based on
a rate of return that recognizes a lower level of risk associated with these assets as compared to the AST-Clinical programs discussed
above.
Deferred
license revenue – In September 2018, Asterias and Novo Nordisk A/S (“Novo Nordisk”) entered into an option
for Novo Nordisk or its designated U.S. affiliate to license, on a non-exclusive basis, certain intellectual property related
to culturing pluripotent stem cells, such as hES cells, in suspension. Under the terms of the option, Asterias received a one-time
upfront payment of $1.0 million, in exchange for a 24-month period option to negotiate a non-exclusive license during which time
Asterias has agreed to not grant any exclusive licenses inconsistent with the Novo Nordisk option. This option is considered a
performance obligation as it provides Novo Nordisk with a material right that it would not receive without entering into the contract.
For
business combination purposes under ASC 805, the fair value of this performance obligation to Lineage, from a market participant
perspective, is the estimated costs Lineage may incur, plus a normal profit margin for the level of effort required to perform
under the contract after the acquisition date, assuming Novo Nordisk exercised its option, including, but not limited to, negotiation
costs, legal fees, arbitration, if any, and other related costs. Management has estimated those costs, plus a normal profit margin,
to be approximately $200,000 in the purchase price allocation. This amount was originally recorded as deferred revenue and subsequently
recognized as revenue in September 2020 when Novo Nordisk did not exercise the option.
Liability
classified warrants – On May 13, 2016, in connection with a common stock offering, Asterias issued warrants to purchase
2,959,559 shares of Asterias common stock (the “Asterias Warrants”) with an exercise price of $4.37 per share that
expire in five years from the issuance date, or May 13, 2021. As of the closing of the Asterias Merger, there were 2,813,159 Asterias
Warrants outstanding. The Asterias Warrants contain certain provisions in the event of a Fundamental Transaction, as defined in
the warrant agreement governing the Asterias Warrants (“Warrant Agreement”), that Asterias or any successor entity
will be required to purchase, at a holder’s option, exercisable at any time concurrently with or within thirty days after
the consummation of the fundamental transaction, the Asterias Warrants for cash in an amount equal to the calculated value of
the unexercised portion of such holder’s warrants, determined in accordance with the Black-Scholes option pricing model
with significant inputs as specified in the Warrant Agreement. The Asterias Merger was a Fundamental Transaction for purposes
of the Asterias Warrants.
The
fair value of the Asterias Warrants was determined by using Black-Scholes option pricing models which take into consideration
the probability of the Fundamental Transaction, which for purposes of the above valuation was assumed to be at 100% and net cash
settlement occurring, using the contractual remaining term of the warrants. In applying these models, these inputs included key
assumptions including the per share closing price of Lineage common shares on March 8, 2019, volatility computed in accordance
with the provisions of the Warrant Agreement and, to a large extent, assumptions based on discussions with a majority of the holders
of the Asterias Warrants since the closing of the Asterias Merger to settle the Asterias Warrants in cash or in common shares
of Lineage. Based on such discussions, Lineage believes the fair value of the Asterias Warrants as of the closing of the Asterias
Merger is not subject to change significantly, however, to the extent any Asterias Warrants that were not settled in cash or in
Lineage common shares discussed below, were automatically converted to Lineage warrants 30 days after the closing of the Asterias
Merger. In April 2019, Asterias Warrants representing approximately $372,000 in fair value were settled: $332,000 in fair value
was settled in exchange for 251,835 common shares of Lineage, and $40,000 in fair value was settled in exchange for cash. The
Asterias Warrants settled in exchange for common shares of Lineage were held by Broadwood Partners, L.P., an Asterias and Lineage
shareholder. The Asterias Warrants settled in exchange for cash were held by other parties. The remaining Asterias Warrants (representing
approximately $495,000 in fair value as of March 31, 2019) were converted into warrants to purchase common shares of Lineage using
the Merger Exchange Ratio (the “Lineage Warrants”).
As
of December 31, 2020, the total number of common shares of Lineage subject to warrants that were assumed by Lineage in connection
with the Asterias Merger was 1,089,900, with similar terms and conditions retained under the Lineage Warrants as per the original
Warrant Agreements. The Lineage Warrants have an exercise price of $6.15 per warrant share and expire on May 13, 2021. Lineage
is accounting for the outstanding Lineage Warrants as a liability at fair value, with subsequent changes to the fair value of
the Lineage Warrants at each reporting period thereafter included in the consolidated statement of operations (see Note 11).
Fair
value of Lineage common shares held by Asterias – As of March 8, 2019, Asterias held 2,621,811 common shares of Lineage
as marketable securities on its standalone financial statements. The fair value of those shares acquired by Lineage from Asterias
is determined based on the $1.31 per share closing price of Lineage common shares on March 8, 2019. Although treasury shares are
not considered an asset and were retired upon Lineage’s acquisition of Asterias, the fair value of those shares is a part
of the purchase price allocation shown in the tables above. These Lineage shares were retired at the completion of the Asterias
Merger.
Goodwill
– Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred
and the values assigned to the assets acquired and liabilities assumed. Goodwill is not amortized but is tested for impairment
at least annually, or more frequently if circumstances indicate potential impairment.
Depending
on the structure of a particular acquisition, goodwill and identifiable intangible assets may not be deductible for tax purposes.
Goodwill recorded in the Asterias Merger is not expected to be deductible for tax purposes (see Note 13).
During
the years ended December 31, 2020 and 2019, Lineage incurred $0.7 million and $5.1 million, respectively, in acquisition related
costs which were recorded in general and administrative expenses in the accompanying consolidated statements of operations.
Prior
to the Asterias Merger being consummated in March 2019, Lineage elected to account for its 21.7 million shares of Asterias common
stock at fair value using the equity method of accounting. The fair value of the Asterias shares was approximately $20.2 million
as of March 8, 2019, the closing date of the Asterias Merger, based on $0.93 per share, which was calculated by multiplying (a)
$1.31, the closing price of Lineage common shares on such date by (b) the Merger Exchange Ratio. The fair value of the Asterias
shares was approximately $13.5 million as of December 31, 2018, based on the closing price of Asterias common stock of $0.62 per
share on such date. Accordingly, Lineage recorded an unrealized gain of $6.7 million for the year ended December 31, 2019, representing
the change in fair value of Asterias common stock from December 31, 2018 to March 8, 2019. All share prices were determined based
on the closing price of Lineage or Asterias common stock on the NYSE American on the applicable dates.
Asterias
Merger Related Litigation – See Note 14 Commitments and Contingencies for discussion regarding litigation related
to the Asterias Merger.
4.
Accounting for Common Stock of OncoCyte, at Fair Value
Prior
to September 11, 2019, Lineage elected to account for its shares of OncoCyte common stock at fair value using the equity method
of accounting. Lineage sold 2.25 million shares of OncoCyte common stock for net proceeds of $4.2 million in July 2019. Accordingly,
Lineage’s ownership in OncoCyte was reduced from 28% to 24%. Lineage sold an additional 4.0 million shares of OncoCyte common
stock for net proceeds of $6.5 million on September 11, 2019. Lineage’s ownership in OncoCyte was further reduced to 16%
at this time. Effective September 11, 2019, Lineage began accounting for its shares of OncoCyte common stock as marketable equity
securities. The calculation of fair value is the same under the equity method and as a marketable equity security.
As
of December 31, 2019, we had 8.4 million shares of OncoCyte common stock. These shares had a fair value of $19.0 million, based
on the closing price of OncoCyte common stock of $2.25 per share on December 31, 2019.
During
the year ended December 31, 2020, Lineage sold approximately 4.8 million shares of OncoCyte common stock for net proceeds of $10.9
million.
As
of December 31, 2020, we owned 3.6 million shares of OncoCyte common stock. These shares had a fair value of $8.7 million, based
on the closing price of OncoCyte common stock of $2.39 per share on December 31, 2020.
For
the year ended December 31, 2020, we recorded a realized gain of $3.1 million due to sales of OncoCyte shares in the period. In
the same period, we also recorded an unrealized loss of $2.5 million related to its OncoCyte shares. The unrealized loss is comprised
of $3.7 million related to the difference between the book cost basis of OncoCyte shares sold in the period versus the applicable
prior month’s ending OncoCyte stock price, which is offset by $1.2 million related to the shares remaining at December 31,
2020 and the increase in OncoCyte’s stock price from $2.25 at December 31, 2019 to $2.39 at December 31, 2020.
For
the year ended December 31, 2019, we recorded a realized gain of $0.5 million due to sales of OncoCyte shares in the period. We
also recorded an unrealized gain of $8.8 million due to the increase in OncoCyte’s stock price from $1.38 per share at December
31, 2018 to $2.25 per share at December 31, 2019. $8.0 million of the unrealized gain was recorded as an unrealized gain on an
equity method investment as it was prior to September 11, 2019; the remaining $0.8 million was recorded as an unrealized gain
on marketable equity securities.
All
share prices are determined based on the closing price of OncoCyte common stock on the NYSE American on the applicable dates,
or the last day of trading of the applicable quarter, if the last day of a quarter fell on a weekend.
5.
Sale of Significant Ownership Interest in AgeX to Juvenescence Limited
On
August 30, 2018, Lineage entered into a Stock Purchase Agreement with Juvenescence Limited and AgeX, pursuant to which Lineage
sold 14.4 million shares of common stock of AgeX to Juvenescence for $3.00 per share, or an aggregate purchase price of $43.2
million (the “Purchase Price”). Juvenescence paid $10.8 million of the Purchase Price at closing, issued an unsecured
convertible promissory note dated August 30, 2018 in favor of Lineage for $21.6 million (the “Promissory Note”), and
paid $10.8 million on November 2, 2018. The Stock Purchase Agreement contains customary representations, warranties and indemnities
from Lineage relating to the business of AgeX, including an indemnity cap of $4.3 million, which is subject to certain exceptions.
In connection with the sale, Lineage also entered into a Shared Facilities Agreement with AgeX (see Note 10).
The
Promissory Note bore interest at 7% per annum, with principal and accrued interest payable at maturity on August 30, 2020. The
Promissory Note was paid in full for a total of $24.6 million on August 28, 2020.
For
the years ended December 31, 2020, and 2019, Lineage recognized $1,008,000 and $1,512,000, respectively, in interest income on
the Promissory Note.
The
Shared Facilities Agreement was terminated on July 31, 2019 with respect to the use of Lineage’s office and laboratory facilities
and September 30, 2019 with respect to all other remaining shared services.
6.
Property and Equipment, Net
At
December 31, 2020 and 2019, property and equipment, net were comprised of the following (in thousands):
Schedule of Property and Equipment, Net
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Equipment, furniture and fixtures
|
|
$
|
3,628
|
|
|
$
|
4,148
|
|
Leasehold improvements
|
|
|
2,472
|
|
|
|
2,862
|
|
Right-of-use assets
(1)
|
|
|
3,845
|
|
|
|
5,756
|
|
Accumulated depreciation and amortization
|
|
|
(4,315
|
)
|
|
|
(4,591
|
)
|
Property and equipment, net
|
|
$
|
5,630
|
|
|
$
|
8,175
|
|
(1)
|
Lineage
adopted ASC 842 on January 1, 2019. For additional information on this standard and right-of-use assets and liabilities see
Notes 2 and 14.
|
Property and equipment
at December 31, 2020 and 2019 includes $79,000 and $96,000 financed by capital leases, respectively. In September 2020,
Lineage terminated its leases in Alameda and entered into a new lease for a reduced amount of square footage. This resulted in
a net reduction to right-of-use assets of approximately $1.4 million. In December 2020, Cell Cure extended ones of its
leases (“the Original Cell Cure Lease”) for an additional five years, which resulted in a net increase to right-of-use
assets of $0.6 million. See additional information in Note 14.
Depreciation
and amortization expense amounted to $0.9 million and $1.1 million for the years ended December 31, 2020 and 2019, respectively.
During
the year ended December 31, 2020, Lineage sold equipment with a net book value of $32,000 and recognized a loss of $9,000. Lineage
also wrote off assets with net book values of $156,000, with $104,000 of this amount related to the termination of its
leases in Alameda. Additionally, Lineage sold non-capitalized assets for a net gain of $72,000.
During
the year ended December 31, 2019, Lineage sold equipment with a net book value of $209,000 and recognized a loss of $109,000.
Primarily in connection with the close out of the Asterias facility, Lineage also sold non-capitalized assets for a net gain of
$337,000.
Gains related to the
sale of assets are included in research and development expenses on the statement of operations. Write offs of assets are included
in other income, net on the statement of operations.
7.
Goodwill and Intangible Assets, Net
At
December 31, 2020 and 2019, goodwill and intangible assets, net consisted of the following: (in thousands):
Schedule of Goodwill and Intangible Assets, Net
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Goodwill
(1)
|
|
$
|
10,672
|
|
|
$
|
10,672
|
|
|
|
|
|
|
|
|
|
|
Intangible assets:
|
|
|
|
|
|
|
|
|
Acquired IPR&D
– OPC1 (from the Asterias Merger) (2)
|
|
$
|
31,700
|
|
|
$
|
31,700
|
|
Acquired IPR&D
– VAC2 (from the Asterias Merger) (2)
|
|
|
14,840
|
|
|
|
14,840
|
|
Intangible assets subject to amortization:
|
|
|
|
|
|
|
|
|
Acquired patents
|
|
|
18,953
|
|
|
|
18,953
|
|
Acquired
royalty contracts (2)
|
|
|
650
|
|
|
|
650
|
|
Total intangible assets
|
|
|
66,143
|
|
|
|
66,143
|
|
Accumulated amortization
|
|
|
(19,111
|
)
|
|
|
(17,895
|
)
|
Intangible assets, net
|
|
$
|
47,032
|
|
|
$
|
48,248
|
|
(1)
|
Goodwill
represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired
and liabilities assumed in the Asterias Merger (see Note 3).
|
|
|
(2)
|
See
Note 3 for information on the Asterias Merger which was consummated on March 8, 2019.
|
Lineage
amortizes its intangible assets over an estimated period of 5 to 10 years on a straight-line basis. Lineage recognized $1.2 million
and $2.0 million in amortization expense of intangible assets during the years ended December 31, 2020 and 2019, respectively.
Amortization
of intangible assets for periods subsequent to December 31, 2020 is as follows (in thousands):
Schedule of Intangible Assets Future Amortization Expense
Year Ended December 31,
|
|
Amortization Expense
|
|
2021
|
|
$
|
210
|
|
2022
|
|
|
130
|
|
2023
|
|
|
130
|
|
2024
|
|
|
22
|
|
Total
|
|
$
|
492
|
|
8.
Accounts Payable and Accrued Liabilities
At
December 31, 2020 and 2019, accounts payable and accrued liabilities consist of the following (in thousands):
Schedule of Accounts Payable and Accrued Liabilities
|
|
2020
|
|
|
2019
|
|
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Accounts payable
|
|
$
|
2,611
|
|
|
$
|
2,427
|
|
Accrued compensation
|
|
|
1,959
|
|
|
|
1,549
|
|
Accrued liabilities
|
|
|
1,711
|
|
|
|
1,246
|
|
PPP loan payable
|
|
|
523
|
|
|
|
-
|
|
Other current liabilities
|
|
|
9
|
|
|
|
4
|
|
Total
|
|
$
|
6,813
|
|
|
$
|
5,226
|
|
Accrued
liabilities includes $1.0 million related to the signature fee owed to Cancer Research UK, as described in Note 14.
PPP
Loan Payable
In
April 2020, Lineage received a loan for $523,305 from Axos Bank under the PPP contained within the new Coronavirus Aid, Relief
and Economic Security (“CARES”) Act. The PPP loan has a term of two years, is unsecured, and is guaranteed by the
U.S. Small Business Administration (“SBA”). The loan carries a fixed interest rate of one percent per annum, with
the first six months of interest deferred. Under the CARES Act and Paycheck Protection Program Flexibility Act, Lineage will be
eligible to apply for forgiveness of all loan proceeds used to pay payroll costs, rent, utilities and other qualifying expenses
during the 24-week period following receipt of the loan, provided that Lineage maintains its employment and compensation within
certain parameters during such period. Not more than 40% of the forgiven amount may be for non-payroll costs. If the conditions
outlined in the PPP loan program are adhered to by Lineage, all or part of such loan could be forgiven. Lineage believes that
all or a substantial portion of the PPP loan is eligible for forgiveness within one year and classifies the loan as a short-term
liability. On December 27, 2020, the Consolidated Appropriations Act, 2021 (CAA) was signed into law, retroactively allowing a
deduction of the expenses that gave rise to the PPP loan forgiveness, that was previously denied under the CARES Act. California
has partially adopted the federal tax treatment. On February 17, 2021, California issued an Immediate Action Agreement, allowing
companies to deduct up to $150,000 in expenses covered by the PPP loan. However, Lineage cannot provide any assurance whether
the PPP loan will ultimately be forgiven by the SBA. Any forgiven amounts will not be included in Lineage’s taxable income
for federal or California purposes. Lineage applied for full forgiveness of the PPP loan on September 30, 2020.
2019
Separation Payments
In
connection with the Asterias Merger, several Asterias employees were terminated as of the Asterias Merger date. Three of these
employees had employment agreements with Asterias which entitled them to change in control and separation payments in the aggregate
of $2.0 million, which such conditions were met on the Asterias Merger date. Accordingly, $2.0 million was accrued and recorded
in general and administrative expenses on the merger date and paid in April 2019.
Additionally,
Lineage entered into a plan of termination with substantially all other previous employees of Asterias with potential separation
payments in the aggregate of $0.5 million. Termination dates for these individuals ranged from May 31, 2019 to June 28, 2019.
These employees were required to provide services related to the transition and be an employee of the combined company as of their
date of termination in order to receive separation benefits. Since the employees were required to render future services after
the merger date, Lineage recorded the aggregate liability ratably over their respective service periods from the Asterias Merger
date through the above termination dates, in accordance with ASC 420, Exit or Disposal Cost Obligations. All payments were
completed by July 31, 2019.
In
connection with the relocation of Lineage’s corporate headquarters to Carlsbad, California, Lineage entered into a plan
of termination with certain Lineage employees with potential separation payments in the aggregate of $0.7 million. Termination
dates for these individuals range from August 9, 2019 to September 30, 2019. These employees had to provide services related to
the transition of services and activities in connection with the relocation and be an employee of Lineage as of their date of
termination in order to receive separation benefits. Lineage recorded the aggregate liability ratably over their respective service
periods from June 2019 through the above termination dates, in accordance with ASC 420. As of December 31, 2019, all separation
payments had been made.
9.
Fair Value Measurements
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy
prioritizes the inputs to valuation methodologies used to measure fair value (ASC 820-10-50), Fair Value Measurements and Disclosures:
|
●
|
Level
1 – Inputs to the valuation methodology are quoted prices for identical assets or liabilities in active markets.
|
|
|
|
|
●
|
Level
2 – Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar
assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated
by observable market data for substantially the full term of the assets or liabilities.
|
|
|
|
|
●
|
Level
3 – Inputs to the valuation methodology are unobservable; that reflect management’s own assumptions about the
assumptions market participants would make and significant to the fair value.
|
We
measure cash, cash equivalents, marketable securities and our liability classified warrants at fair value on a recurring basis.
The fair values of such assets were as follows for December 31, 2020 and 2019 (in thousands):
Schedule of Fair Value of Assets and Liabilities Valued on Recurring Basis
|
|
|
|
|
Fair Value Measurements Using
|
|
|
|
Balance at December 31, 2020
|
|
|
Quoted
Prices in Active Markets for Identical Assets
(Level
1)
|
|
|
Significant
Other Observable Inputs
(Level
2)
|
|
|
Significant
Unobservable Inputs
(Level
3)
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
32,585
|
|
|
$
|
32,585
|
|
|
$
|
-
|
|
|
$
|
-
|
|
Marketable securities
|
|
|
8,977
|
|
|
|
8,977
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lineage Warrants
|
|
|
1
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1
|
|
Cell Cure Warrants
|
|
|
437
|
|
|
|
-
|
|
|
|
-
|
|
|
|
437
|
|
|
|
|
|
|
Fair Value Measurements Using
|
|
|
|
Balance at December 31, 2019
|
|
|
Quoted
Prices in Active Markets for Identical Assets
(Level
1)
|
|
|
Significant
Other Observable Inputs
(Level
2)
|
|
|
Significant
Unobservable Inputs
(Level
3)
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
9,497
|
|
|
$
|
9,497
|
|
|
$
|
-
|
|
|
$
|
-
|
|
Marketable securities
|
|
|
21,219
|
|
|
|
21,219
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lineage Warrants
|
|
|
20
|
|
|
|
-
|
|
|
|
-
|
|
|
|
20
|
|
Cell Cure Warrants
|
|
|
257
|
|
|
|
-
|
|
|
|
-
|
|
|
|
257
|
|
We
have not transferred any instruments between the three levels of the fair value hierarchy.
In
determining fair value, Lineage utilizes valuation techniques that maximize the use of observable inputs and minimize the use
of unobservable inputs to the extent possible, and also considers counterparty credit risk in its assessment of fair value.
Marketable
securities include our positions in OncoCyte and HBL. These securities have readily determinable fair values quoted on the NYSE
American or TASE stock exchanges. These securities are measured at fair value and reported as current assets on the consolidated
balance sheets based on the closing trading price of the security as of the date being presented.
The
fair value of Lineage’s assets and liabilities, which qualify as financial instruments under FASB guidance regarding disclosures
about fair value of financial instruments, approximate the carrying amounts presented in the accompanying consolidated balance
sheets. The carrying amounts of accounts receivable, prepaid expenses and other current assets, accounts payable, accrued expenses
and other current liabilities approximate fair values because of the short-term nature of these items.
10.
Related Party Transactions
Shared
Facilities and Service Agreements with Affiliates
Under
the terms of the Shared Facilities Agreements, Lineage allowed OncoCyte and AgeX to use Lineage’s premises and equipment
located at Lineage’s headquarters in Alameda, California for the purpose of conducting business. Lineage also provided accounting,
billing, bookkeeping, payroll, treasury, payment of accounts payable, and other similar administrative services to OncoCyte and
AgeX. The Shared Facilities Agreements also allowed Lineage to provide the services of attorneys, accountants, and other professionals
who may provide professional services to Lineage. Lineage also provided OncoCyte and AgeX with the services of laboratory and
research personnel, including Lineage employees and contractors, for the performance of research and development work for OncoCyte
and AgeX at the premises. Shared services with AgeX were terminated on July 31, 2019 with respect to the use of Lineage’s
office and laboratory facilities and September 30, 2019 with respect to all other remaining shared services. Shared services with
OncoCyte were terminated on September 30, 2019, and December 31, 2019 with respect to all other remaining shared services.
Lineage
charged OncoCyte and AgeX a “Use Fee” for services provided and for use of Lineage facilities, equipment, and supplies.
For each billing period, Lineage prorated and allocated to OncoCyte and AgeX costs incurred, including costs for services of Lineage
employees and use of equipment, insurance, leased space, professional services, software licenses, supplies and utilities. The
allocation of costs depended on key cost drivers, including actual documented use, square footage of facilities used, time spent,
costs incurred by Lineage for OncoCyte and AgeX, or upon proportionate usage by Lineage, OncoCyte and AgeX, as reasonably estimated
by Lineage. Lineage, at its discretion, had the right to charge OncoCyte and AgeX a 5% markup on such allocated costs. The allocated
cost of Lineage employees and contractors who provided services was based upon the number of hours or estimated percentage of
efforts of such personnel devoted to the performance of services.
The
Use Fee was determined and invoiced to OncoCyte and AgeX on a regular basis, generally monthly or quarterly. Each invoice was
payable in full within 30 days after receipt. Any invoice, or portion thereof, not paid in full when due bore interest at the
rate of 15% per annum until paid, unless the failure to make a payment was due to any inaction or delay in making a payment by
Lineage. Lineage did not charge OncoCyte or AgeX any interest.
In
addition to the Use Fee, OncoCyte and AgeX reimbursed Lineage for any out of pocket costs incurred by Lineage for the purchase
of office supplies, laboratory supplies, and other goods and materials and services for the account or use of OncoCyte or AgeX.
Lineage was not obligated to purchase or acquire any office supplies or other goods and materials or any services for OncoCyte
or AgeX, and if any such supplies, goods, materials or services were obtained, Lineage could arrange for the suppliers to invoice
OncoCyte or AgeX directly.
The
Use Fees charged to OncoCyte and AgeX shown above were not reflected in revenues, but instead Lineage’s general and administrative
expenses and research and development expenses are shown net of those charges in the consolidated statements of operations.
For
the year ended December 31, 2019, Lineage charged Use Fees of $2,176,000 to OncoCyte and AgeX; $890,000 was offset against general
and administrative expenses and $1,286,000 was offset against research and development expenses.
Other
related party transactions
Lineage
currently pays $5,050 per month for the use of approximately 900 square feet of office space in New York City, which is made available
to Lineage on a month-by-month basis by one of its directors at an amount that approximates his cost (see Note 14). These
payments are expected to cease in March 2021 when the office space lease expires.
In
April 2019, Lineage issued 251,835 common shares of Lineage to Broadwood Partners, L.P., an Asterias and Lineage shareholder,
in exchange for the settlement of Asterias Warrants in connection with the Asterias Merger (see Note 3).
In
connection with the putative shareholder class action lawsuits filed in February 2019 and October 2019 challenging the Asterias
Merger (see Note 14), Lineage has agreed to pay for the legal defense of Neal Bradsher, director, and Broadwood Partners,
L.P., a shareholder of Lineage, and Broadwood Capital, Inc., which manages Broadwood Partners, L.P., all of which were named in
the lawsuits. Through December 31, 2020, Lineage has incurred a total of $359,000 in legal expenses on behalf of the director,
shareholder and the manager of the shareholder.
As
part of financing transactions in which there were multiple other purchasers, Broadwood Partners, L.P. purchased 1,000,000 shares,
2,000,000 shares and 623,090 shares of OncoCyte common stock from Lineage in July 2019, September 2019 and January 2020, respectively.
11.
Shareholders’ Equity
Preferred
Shares
Lineage
is authorized to issue 2,000,000
shares of preferred stock. The preferred shares may
be issued in one or more series as the board of directors may by resolution determine. The board of directors is authorized to
fix the number of shares of any series of preferred shares and to determine or alter the rights, preferences, privileges, and
restrictions granted to or imposed on the preferred shares as a class, or upon any wholly unissued series of any preferred shares.
The board of directors may, by resolution, increase or decrease (but not below the number of shares of such series then outstanding)
the number of shares of any series of preferred shares subsequent to the issue of shares of that series. As of December 31, 2020,
no shares of preferred stock were issued or outstanding.
Common
Shares
At
December 31, 2020, Lineage was authorized to issue 250,000,000 common shares, no par value. As of December 31, 2020 and 2019,
Lineage had 153,095,883 and 149,804,284 issued and outstanding common shares, respectively.
During
the years ended December 31, 2020 and 2019, Lineage issued 47,000
and 189,000
common shares, net of shares withheld
and retired for employee taxes paid, respectively, for vested restricted stock units (see Note 12).
At-the-Market
(“ATM”) Offering
On
May 1, 2020, Lineage entered into the Sales Agreement, pursuant to which Lineage may offer and sell, from time to time, through
Cantor Fitzgerald, common shares of Lineage (“ATM Shares”) having an aggregate offering price of up to $25,000,000.
Lineage is not obligated to sell any ATM Shares. Subject to the terms and conditions of the Sales Agreement, Cantor Fitzgerald
will use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal
law, rules and regulations, and the rules of the NYSE American, to sell the ATM Shares from time to time based upon Lineage’s
instructions, including any price, time or size limits specified by Lineage. Under the Sales Agreement, Cantor Fitzgerald may
sell the ATM Shares by any method deemed to be an “at-the-market” offering as defined in Rule 415(a)(4) under the
Securities Act of 1933, as amended, or by any other method permitted by law, including in privately negotiated transactions. Cantor
Fitzgerald’s obligations to sell the ATM Shares are subject to satisfaction of certain conditions, including the continued
effectiveness of Lineage’s Registration Statement on Form S-3 (File No. 333-237975), which was filed with the Commission
on May 1, 2020 and was declared effective on May 8, 2020. The Sales Agreement replaced the previous sales agreement with Cantor
that had been entered into in April 2017. As of December 31, 2020, Lineage sold 3,094,322
ATM Shares for gross and net proceeds
of $5.1
million and $5.0
million, respectively (in each
case, which excludes $0.3 million of cash in transit related to 2020 sales that settled in 2021). In the first quarter of
2021 through March 5, 2021, Lineage sold an additional 7,941,122 ATM Shares for gross and net proceeds of $19.9
million and $19.3
million, respectively (in each
case, which includes $0.3 million of cash in transit related to 2020 sales that settled in 2021). On March 5, 2021,
Lineage filed a prospectus supplement with the SEC in connection with the offer and sale of an additional $25
million of ATM Shares under the Sales
Agreement.
Lineage
agreed to pay Cantor Fitzgerald a commission of 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal
fees and disbursements and provide Cantor Fitzgerald with customary indemnification and contribution rights. The Sales Agreement
may be terminated by Cantor Fitzgerald or Lineage at any time upon notice to the other party, or by Cantor Fitzgerald at any time
in certain circumstances, including the occurrence of a material and adverse change in Lineage’s business or financial condition
that makes it impractical or inadvisable to market the shares or to enforce contracts for the sale of the shares.
Warrants
Lineage
(previously Asterias) Warrants – Liability Classified
In
March 2019, in connection with the closing of the Asterias Merger, Lineage assumed outstanding Asterias Warrants. As of December
31, 2020, the total number of common shares of Lineage subject to warrants that were assumed by Lineage in connection with the
Asterias Merger was 1,089,900, which were converted to Lineage Warrants 30 days after the closing of the Asterias Merger, with
similar terms and conditions retained under the Lineage Warrants as per the original Warrant Agreements. The Lineage Warrants
have an exercise price of $6.15 per warrant share and expire on May 13, 2021.
Cell
Cure Warrants – Liability Classified
Cell
Cure has two sets of issued warrants (the “Cell Cure Warrants”). Warrants to purchase 24,566 Cell Cure ordinary shares
at an exercise price of $40.5359 were issued to HBL in July 2017. These warrants expire in July 2022. Warrants to purchase 13,738
Cell Cure ordinary shares at exercise prices ranging from $32.02 to $40.02 per share were issued to consultants. 11,738 of these
warrants were cashless exercised in October 2020. The expense related to the cashless exercise was approximately $44,000
and it was recorded as other income/(expense), net on the statements of operations. The remaining 2,000 warrants have an exercise
price of $40.00 and expire in January 2024.
ASC
815 requires freestanding financial instruments, such as warrants, with exercise prices denominated in currencies other than the
functional currency of the issuer to be accounted for as liabilities at fair value, with all subsequent changes in fair value
after the issuance date to be recorded as gains or losses in the consolidated statements of operations. Because the exercise price
of the Cell Cure Warrants is U.S. dollar-denominated and settlement is not expected to occur in the next twelve months, Cell Cure
classified the Cell Cure Warrants as a long-term liability in accordance with ASC 815.
The
fair value of the Cell Cure Warrants at the time of issuance was determined by using the Black-Scholes option pricing model using
the respective contractual term of the warrants. In applying this model, the fair value is determined by applying Level 3 inputs,
as defined by ASC 820; these inputs are based on certain key assumptions including the fair value of the Cell Cure ordinary shares,
adjusted for lack of marketability, as appropriate, and the expected stock price volatility over the term of the Cell Cure Warrants.
The fair value of the Cell Cure ordinary shares is determined by Cell Cure’s Board of Directors, which may engage a valuation
specialist to assist it in estimating the fair value, or may use recent transactions in Cell Cure shares, if any, as a reasonable
approximation of fair value, or may apply other reasonable methods to determining the fair value, including a discount for lack
of marketability. In connection with the cashless exercise in October 2020, Cell Cure had an independent third-party update the
fair value of the Cell Cure shares. Lineage determines the stock price volatility using historical prices of comparable public
company common stock for a period equal to the remaining term of the Cell Cure Warrants. The Cell Cure Warrants are revalued each
reporting period using the same methodology described above, with changes in fair value included as gains or losses in other income
and expenses, net, in the consolidated statements of operations.
For
the years ended December 31, 2020 and 2019, Lineage recorded a noncash loss of $0.2 million and a noncash gain of $0.1 million,
respectively, for the increase/decrease in the fair value of the Cell Cure Warrants included in other income and expenses, net
for each period. The increase in the fair value of the Cell Cure Warrants was mainly attributable to an increase in the fair value
of the Cell Cure shares due to additional progress made on the OpRegen program in 2020. As of December 31, 2020 and 2019, the
Cell Cure Warrants, valued at $0.4 million and $0.3 million, respectively, were included in long-term liabilities on the consolidated
balance sheets.
12.
Stock-Based Awards
Equity
Incentive Plan Awards
Effective
November 8, 2019, Lineage adopted an amendment changing the name of the BioTime, Inc. 2012 Equity Incentive 2012 Plan to the Lineage
Cell Therapeutics, Inc. 2012 Equity Incentive Plan (the “2012 Plan”). The 2012 Plan provides for the grant of stock
options, restricted stock, restricted stock units (“RSUs”) and stock appreciation rights. As of December 31, 2020,
a maximum of 24,000,000 common shares were available for grant under the 2012 Plan. Recipients of stock options are eligible to
purchase common shares at an exercise price equal to the fair market value of such shares on the date of grant. The maximum term
of options granted under the 2012 Plan is 10 years. Stock options generally vest over a four-year period based on continuous service;
however, the 2012 Plan allows for other vesting periods. Upon the expiration of the restrictions applicable to an RSU, Lineage
will either issue to the recipient, without charge, one common share per RSU or cash in an amount equal to the fair market value
of one common share. RSUs granted from the 2012 Plan reduce the shares available for grant by two shares for each RSU granted.
A
summary of Lineage’s 2012 Plan activity and other stock option awards granted outside of the 2012 Plan related information
is as follows (in thousands, except per share amounts):
Schedule of Share-based Compensation, Employee Stock Purchase Plan, Activity
|
|
Shares
Available
for
Grant
|
|
|
Number
of
Options
Outstanding
|
|
|
Number
of
RSUs
Outstanding
|
|
|
Weighted
Average
Exercise
Price
|
|
December 31, 2018
|
|
|
1,885
|
|
|
|
13,867
|
|
|
|
402
|
|
|
$
|
2.44
|
|
Adjustment due to the AgeX Distribution
|
|
|
117
|
|
|
|
(2
|
)
|
|
|
3
|
|
|
|
-
|
|
Increase to the 2012 Plan
|
|
|
8,000
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Options granted
|
|
|
(3,581
|
)
|
|
|
3,581
|
|
|
|
-
|
|
|
|
1.06
|
|
Options forfeited
|
|
|
2,736
|
|
|
|
(2,736
|
)
|
|
|
-
|
|
|
|
2.13
|
|
Restricted stock units vested
|
|
|
-
|
|
|
|
-
|
|
|
|
(239
|
)
|
|
|
-
|
|
December 31, 2019
|
|
|
9,157
|
|
|
|
14,710
|
|
|
|
166
|
|
|
$
|
2.17
|
|
December 31, 2019
|
|
|
9,157
|
|
|
|
14,710
|
|
|
|
166
|
|
|
$
|
2.17
|
|
Options granted
|
|
|
(5,256
|
)
|
|
|
5,256
|
|
|
|
-
|
|
|
|
0.71
|
|
Options forfeited
|
|
|
4,101
|
|
|
|
(4,101
|
)
|
|
|
-
|
|
|
|
2.61
|
|
Restricted units vested
|
|
|
-
|
|
|
|
-
|
|
|
|
(73
|
)
|
|
|
-
|
|
December 31, 2020
|
|
|
8,002
|
|
|
|
15,865
|
|
|
|
93
|
|
|
$
|
1.57
|
|
Options exercisable at December 31, 2020
|
|
|
|
|
|
|
8,341
|
|
|
|
|
|
|
$
|
2.16
|
|
As
of December 31, 2020, options outstanding and options exercisable under the 2012 Plan have a weighted-average remaining contractual
term of 6.3 years and 4.1 years, respectively, and intrinsic value of $7.4 million and $0.9 million, respectively.
In
connection with the vested RSUs during the year ended December 31, 2020, Lineage paid $27,000 in minimum employee withholding
taxes in exchange for 26,000 vested Lineage common shares issuable to the employees and immediately retired those shares. For
the year ended December 31, 2020, Lineage recorded a noncash stock-based compensation expense of $0.1 million, in connection with
the vested RSUs, included in consolidated stock-based compensation expense.
In
connection with the vested RSUs during the year ended December 31, 2019, Lineage paid $0.1 million in minimum employee withholding
taxes in exchange for 109,000 vested Lineage common shares issuable to the employees and immediately retired those shares. For
the year ended December 31, 2019, Lineage recorded a noncash stock-based compensation expense of $0.3 million, in connection with
the vested RSUs, included in consolidated stock-based compensation expense.
At
the effective time of the Asterias Merger, Lineage assumed sponsorship of the Asterias 2013 Equity Incentive Plan (the “Asterias
Equity Plan”), with references to Asterias and Asterias common stock therein to be deemed references to Lineage and Lineage
common shares. There were 7,309,184 shares available under the Asterias Equity Plan immediately before the closing of the Asterias
Merger, which became 5,189,520 shares immediately following the Asterias Merger. The shares available under the Asterias Equity
Plan will be for awards granted to those former Asterias employees who continued as Lineage employees upon consummation of the
Asterias Merger.
A summary of activity under the Asterias Equity Plan from the closing date of the Asterias Merger through December
31, 2020 is as follows (in thousands, except per share amounts):
Schedule of Share-based Compensation, Employee Stock Purchase Plan, Activity
|
|
Shares
Available
for
Grant
|
|
|
Number
of
Options
Outstanding
|
|
|
Number
of
RSUs
Outstanding
|
|
|
Weighted
Average
Exercise
Price
|
|
March 8, 2019
|
|
|
5,190
|
|
|
|
-
|
|
|
|
-
|
|
|
$
|
-
|
|
Options granted
|
|
|
(490
|
)
|
|
|
490
|
|
|
|
-
|
|
|
|
1.59
|
|
Options forfeited
|
|
|
140
|
|
|
|
(140
|
)
|
|
|
-
|
|
|
|
1.63
|
|
December 31, 2019
|
|
|
4,840
|
|
|
|
350
|
|
|
|
-
|
|
|
$
|
1.57
|
|
December 31, 2019
|
|
|
4,840
|
|
|
|
350
|
|
|
|
-
|
|
|
$
|
1.57
|
|
Options granted
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Options forfeited
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
December 31, 2020
|
|
|
4,840
|
|
|
|
350
|
|
|
|
-
|
|
|
$
|
1.57
|
|
Options exercisable at December 31, 2020
|
|
|
|
|
|
|
153
|
|
|
|
|
|
|
$
|
1.57
|
|
As
of December 31, 2020, options outstanding and options exercisable under the Asterias Equity Plan both have a weighted-average
remaining contractual term of 8.2 years and intrinsic value of $67,000 and $29,000, respectively.
Stock-based
compensation expense
The
fair value of each option award is estimated on the date of grant using a Black-Scholes option pricing model applying the weighted-average
assumptions noted in the following table:
Schedule of Weighted Average Assumptions to Calculate Fair Value of Stock Options
|
|
Year Ended December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Expected life (in years)
|
|
|
6.2
|
|
|
|
6.0
|
|
Risk-free interest rates
|
|
|
0.8%
|
|
|
|
2.2%
|
|
Volatility
|
|
|
67.7%
|
|
|
|
63.1%
|
|
Dividend yield
|
|
|
-%
|
|
|
|
-%
|
|
The
weighted-average estimated fair value of stock options granted under the 2012 Plan and other stock option awards granted outside
of the 2012 Plan, during the years ended December 31, 2020 and 2019 was $0.43 and $0.68 per share, respectively.
Operating
expenses include stock-based compensation expense as follows (in thousands):
Schedule of Stock Based Compensation Expense
|
|
Year Ended December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Research and development
|
|
$
|
464
|
|
|
$
|
516
|
|
General and administrative
|
|
|
1,763
|
|
|
|
3,064
|
|
Total stock-based compensation expense
|
|
$
|
2,227
|
|
|
$
|
3,580
|
|
The
expense related to 84,940 shares of Asterias restricted stock unit awards that immediately vested on the closing of the Asterias
Merger and converted into the right to receive common shares of Lineage based on the Merger Exchange Ratio, resulting in 60,304
common shares of Lineage issued on March 8, 2019, was included in stock-based compensation expense for the year ended December
31, 2019. The expense was not included as part of the purchase price of the Asterias Merger because these awards were principally
attributable to post-combination services.
As
of December 31, 2020, total unrecognized compensation costs related to unvested stock options under Lineage’s 2012 Plan
was $3.9 million, which is expected to be recognized as expense over a weighted average period of approximately 2.6 years.
13.
Income Taxes
For
the year ended December 31, 2020, Lineage recorded a $1.2 million deferred tax benefit for income taxes.
For
the year ended December 31, 2019, Lineage recorded a $7.4 million valuation allowance release and corresponding benefit for income
taxes. This was comprised of a federal and state deferred income tax benefit of $3.6 million and $3.8 million, respectively, for
the year ended December 31, 2019 due to the indefinite lived assets generated in the period and the release of the valuation allowance.
The Company also recorded a current foreign income tax expense of $31,000 for the year ended December 31, 2019.
The
domestic and foreign breakout of loss before net income tax benefit was as follows:
Schedule of Income before Income Tax, Domestic and Foreign
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Domestic
|
|
$
|
)
|
|
|
)
|
Foreign
|
|
|
)
|
|
|
)
|
Loss before net income tax benefit
|
|
$
|
)
|
|
|
)
|
Income
taxes differed from the amounts computed by applying the indicated current U.S. federal income tax rate to pretax losses from
operations as a result of the following:
Schedule of Income Tax Rate Reconciliation
|
|
Year Ended December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Computed tax benefit at federal statutory rate
|
|
|
21%
|
|
|
|
21%
|
|
Research and development and other credits
|
|
|
1%
|
|
|
|
3%
|
|
Removal of DTL for equity investment in Asterias due to merger
|
|
|
-%
|
|
|
|
22%
|
|
Permanent differences
|
|
|
-%
|
|
|
|
(1)%
|
|
Change in valuation allowance
|
|
|
(17)%
|
|
|
|
(106)%
|
|
Establish DTL for deferred assets from Asterias Merger
|
|
|
-%
|
|
|
|
42%
|
|
Deconsolidation of AgeX and subsidiaries net deferred tax assets
|
|
|
-%
|
|
|
|
3%
|
|
State tax benefit, net of effect on federal income taxes
|
|
|
3%
|
|
|
|
54%
|
|
Foreign rate differential and other
|
|
|
(2)%
|
|
|
|
1%
|
|
Income tax benefit
|
|
|
6%
|
|
|
|
39%
|
|
The
primary components of the deferred tax assets and liabilities at December 31, 2020 and 2019 were as follows (in thousands):
Schedule of Components of Deferred Tax Assets and Liabilities
|
|
2020
|
|
|
2019
|
|
|
|
December 31,
|
|
Deferred tax assets/(liabilities):
|
|
2020
|
|
|
2019
|
|
Net operating loss carryforwards
|
|
$
|
63,941
|
|
|
$
|
62,060
|
|
Research and development and other credits
|
|
|
8,878
|
|
|
|
8,619
|
|
Patents and licenses
|
|
|
1,178
|
|
|
|
1,220
|
|
Stock options
|
|
|
2,131
|
|
|
|
2,708
|
|
Operating lease liability
|
|
|
242
|
|
|
|
832
|
|
Operating lease ROU assets
|
|
|
(215
|
)
|
|
|
(775
|
)
|
Equity method investments and marketable securities at fair value
|
|
|
(15,685
|
)
|
|
|
(19,367
|
)
|
Other, net
|
|
|
1,523
|
|
|
|
984
|
|
Total
|
|
|
61,993
|
|
|
|
56,281
|
|
Valuation allowance
|
|
|
(64,069
|
)
|
|
|
(59,596
|
)
|
Net deferred tax liabilities
|
|
$
|
(2,076
|
)
|
|
$
|
(3,315
|
)
|
A
valuation allowance is provided when it is more likely than not that some portion of the deferred tax assets will not be realized.
Lineage established a full valuation allowance as of December 31, 2018 due to the uncertainty of realizing future tax benefits
from its net operating loss carryforwards and other deferred tax assets, including foreign net operating losses generated by its
subsidiaries. During the year ended December 31, 2019, a portion of the valuation allowance was released as it relates to Lineage’s
indefinite lived assets that can be used against the indefinite lived liabilities. The amount of the valuation allowance released
was $7.4 million;
as new indefinite lived deferred tax assets are generated, we will continue to book provision benefits until the deferred tax
liability position is exhausted, barring any new developments.
As
of December 31, 2020, Lineage has gross net operating loss carryforwards of approximately $169.9 million for federal purposes.
As of December 31, 2020, Lineage’s foreign subsidiaries have net operating loss carryforwards of approximately $88.3 million
which carryforward indefinitely.
As
of December 31, 2020, Lineage has net operating losses of $118.6 million for state tax purposes.
As
of December 31, 2020, Lineage has research tax credit carryforwards for federal and state tax purposes of $3.2 million and $5.7
million, respectively. These tax credits reflect the amounts for Lineage, Asterias and OrthoCyte as of December 31, 2020. With
the announcement of the California agreement with the Senate, allowing a deduction of up to $150,000 for expenses paid with the
PPP loan proceeds, any amount disallowed for California, that relates to R&D wages, may be limited. For federal purposes,
the credits generated each year have a carryforward period of 20 years. The federal tax credits expire in varying amounts between
2020 and 2040, while the state tax credits have no expiration period.
On
August 5, 2020, Lineage began the liquidation of its foreign subsidiary BioTime Asia. At the time of the liquidation, BioTime
Asia had an intercompany payable due to Lineage. For book purposes, the corresponding balances eliminate in consolidation. For
federal purposes, the activities of their foreign subsidiaries are not included in the consolidated tax return. Accordingly, the
payable was written off for tax purposes by Lineage, creating a $3.6 million bad debt deduction increasing its NOL carryover.
For California, the activities of its foreign subsidiaries, including BioTime Asia, are included in the combined tax return. As
such, the corresponding intercompany balances are eliminated.
Other
Transactions and Related Impact on Income Taxes
The
market value of the respective shares Lineage holds in OncoCyte, AgeX and Asterias (through the merger date of March 8, 2019)
creates a deferred tax liability to Lineage based on the closing price of the security, less the tax basis of the security Lineage
has in such shares. The deferred tax liability generated by shares that Lineage holds as of December 31, 2020 and 2019, is a source
of future taxable income to Lineage, as prescribed by ASC 740-10-30-17, that will more likely than not result in the realization
of its deferred tax assets to the extent of those deferred tax liabilities. This deferred tax liability is determined based on
the closing price of those securities as of December 31, 2020 and 2019.
Other
Income Tax Matters
Internal
Revenue Code Section 382 places a limitation (“Section 382 Limitation”) on the amount of taxable income that can be
offset by NOL carryforwards after a change in control (generally greater than 50% change in ownership within a three-year period)
of a loss corporation. California has similar rules. Generally, after a change in control, a loss corporation cannot deduct NOL
carryforwards in excess of the Section 382 Limitation. Due to these “change in ownership” provisions, utilization
of the NOL and tax credit carryforwards may be subject to an annual limitation regarding their utilization against taxable income
in future periods.
Lineage
files a U.S. federal income tax return as well as various state and foreign income tax returns. In general, Lineage is no longer
subject to tax examination by major taxing authorities for years before 2016. Although the statute is closed for purposes of assessing
additional income and tax in these years, the taxing authorities may still make adjustments to the NOL and credit carryforwards
used in open years. Therefore, the statute should be considered open as it relates to the NOL and credit carryforwards used in
open years.
Lineage
may be subject to potential examination by U.S. federal, U.S. states or foreign jurisdiction authorities in the areas of income
taxes. These potential examinations may include questioning the timing and amount of deductions, the nexus of income among various
tax jurisdictions and compliance with U.S. federal, U.S. state and foreign tax laws. Lineage’s management does not expect
that the total amount of unrecognized tax benefits will materially change over the next twelve months.
Lineage’s
practice is to recognize interest and penalties related to income tax matters in tax expense. As of December 31, 2020 and 2019,
Lineage has no accrued interest and penalties.
14.
Commitments and Contingencies
Carlsbad
Lease
In
May 2019, Lineage entered into a lease for approximately 8,841 square feet of rentable space in an office park in Carlsbad, California
(the “Carlsbad Lease”). The term of the Carlsbad Lease commenced on August 1, 2019 and expires on October 31, 2022.
Base rent under the
Carlsbad Lease as of August 1, 2020 is $18,386 per month and will increase by 3% annually on every August
1 thereafter during the lease term. Base rent for the first twenty-four months of the lease is based upon a deemed rentable area
of 7,000 square feet. Base rent is abated for months two through five of the lease.
In
addition to base rent, Lineage will pay a pro rata portion of increases in certain expenses, including real property taxes, utilities
(to the extent not separately metered to the leased space) and the landlord’s operating expenses, over the amounts of those
expenses incurred by the landlord. As security for the performance of its obligations under the Carlsbad Lease, Lineage provided
the landlord with a security deposit of $17,850.
Alameda
Leases and Alameda Sublease
In
December 2015, Lineage entered into leases of office and laboratory space located in two
buildings in Alameda, California (the “Alameda
Leases”) comprised of 22,303
square feet (the “1010 Atlantic
Premises”) and 8,492
square feet (the “1020 Atlantic
Premises”). Base rent under the Alameda Leases beginning on February 1, 2020 was $72,636
per month with annual increases of approximately
3%.
In addition to base rent, Lineage paid a pro rata portion of increases in certain expenses,
including real property taxes, utilities (to the extent not separately metered to the leased space) and the landlord’s operating
expenses, over the amounts of those expenses incurred by the landlord. As security for its obligations, Lineage provided
the landlord with a security deposit of approximately $424,000,
which was reduced to $78,000
on January 24, 2019 in accordance with
the terms of the lease. The security deposit amount is considered restricted cash and is included in prepaid expenses and other
current assets as of December 31, 2020 (See Note 2).
In
April 2020, Lineage entered into a sublease with Industrial Microbes, Inc. (“Industrial Microbes”) for the use of
10,000 square feet in the 1010 Atlantic Premises (the “Industrial Microbes Sublease”). Base rent under the Industrial
Microbes Sublease was $28,000 per month with annual increases of approximately 3%. Base
rent for the first month was abated. In addition to base rent and utilities, Industrial Microbes paid a pro-rata portion of increases
in operating expenses, after an abatement period of one year.
On
September 11, 2020, Lineage entered into a Lease Termination Agreement with the landlord terminating the Alameda Leases effective
as of August 31, 2020 for the 1020 Atlantic Premises and September 30, 2020 for the 1010 Atlantic Premises. In
consideration for the termination of the leases, Lineage paid a termination fee of $130,000 and other amounts due under the terms
of the Alameda Leases through the applicable effective termination dates, except that no rent was due with respect to the 1020
Atlantic Premises after July 31, 2020. Lineage’s security deposit is expected to be returned to Lineage by March
31, 2021. Lineage paid a separate termination fee of $30,000 to Industrial Microbes in connection
with the termination of the Industrial Microbes Sublease and returned the $56,000 security deposit paid by Industrial Microbes.
For the period of sublease from mid-April 2020 through September 2020, Lineage received $119,000 in rental income from Industrial
Microbes.
Lineage
will continue to occupy approximately 2,432 square feet of the 1010 Atlantic Premises under a new sublease agreement (the “Alameda
Sublease”). The term of the Alameda Sublease
is from October 1, 2020 through January 31, 2023. Base rent under the Alameda Sublease is $14,592 per month with annual increases
of 3% each October 1 thereafter during the lease term. Base rent for the first month was abated. Lineage paid a security deposit
of $16,000 under the Alameda Sublease; this amount is considered restricted cash and is included in deposits and other long-term
assets as of December 31, 2020 (see Note 2).
Based
on the smaller footprint, and after taking into consideration the fees disclosed above, Lineage has reduced its contractual obligations
by approximately $780,000 over the remaining life of the original leases through January 31, 2023.
New
York Leased Office Space
Lineage
currently pays $5,050 per month for the use of approximately 900 square feet of office space in New York City, which is made available
to Lineage for use in conducting meetings and other business affairs, on a month-by-month basis, by one of its directors at an
amount that approximates his cost. This lease was not in the scope of ASC 842 because it is a month to month lease (see Note 2).
These payments are expected to cease in March 2021 when the office space lease expires.
Cell
Cure Leases
Cell
Cure leases 728.5 square meters (approximately 7,842 square feet) of office and laboratory space in Jerusalem, Israel under a
lease that expires December 31, 2025, with an option to extend the lease for 5 years (the “Original Cell Cure Lease”).
Base monthly rent is NIS 39,776 (approximately US $12,200 per month using the December 7, 2020 exchange rate). In addition to
base rent, Cell Cure pays a pro rata share of real property taxes and certain costs related to the operation and maintenance of
the building in which the leased premises are located.
On
January 28, 2018, Cell Cure entered into another lease agreement for an additional 934 square meters (approximately 10,054 square
feet) of office space in the same facility in Jerusalem, Israel under a lease that expires on December 31, 2025, with two options
to extend the lease for 5 years each (the “January 2018 Lease”). The January 2018 Lease commenced on April 1, 2018
and included a leasehold improvement construction allowance of up to NIS 4,000,000 (approximately up to $1.1 million using the
December 31, 2018 exchange rate) from the landlord. The leasehold improvements were completed in December 2018 and the entire
allowance was used. Beginning on January 1, 2019, combined base rent and construction allowance payments for the January 2018
Lease are NIS 93,827 per month (approximately $26,000 per month).
Prior to the adoption
of ASC 842 on January 1, 2019, Cell Cure was considered the owner of the tenant improvements under construction under ASC 840-40-55
as Cell Cure, among other things, had the primary obligation to pay for construction costs and Cell Cure retains exclusive use
of the leased facilities for its office, research and cGMP manufacturing facility requirements after construction was completed
(“build to suit” lease). In accordance with the ASC 840 guidance, amounts expended by Cell Cure for construction was
reported as construction in progress, and the proceeds received from the landlord, if any, are reported as a lease liability. As
of December 31, 2018, approximately $1.1 million under the January 2018 Lease was incurred and recorded as leasehold improvement
construction in progress, with a corresponding amount included in long term lease liability representing the full amount utilized
from the landlord’s leasehold improvement construction allowance. By March 2019, the landlord paid the complete leasehold
improvement construction allowance and the property was placed in service.
See
Note 2 for discussion of the impact of adoption of ASC 842 on January 1, 2019, and below for the ROU assets and liabilities recorded
in connection with the adoption of ASC 842 as of, and during the year ended December 31, 2019 for the Original Cell Cure Lease
and January 2018 Lease (the “Cell Cure Leases”).
In
December 2018, Cell Cure made a deposit required under the January 2018 Lease, which amount of $420,000 is included in
deposits and other long-term assets on the consolidated balance sheet as of December 31, 2020, to be held as restricted cash during
the term of the January 2018 Lease.
Adoption
of ASC 842
The
below tables provide the amounts recorded in connection with the adoption of ASC 842 as of, and for the years ended December 31,
2020 and 2019, for Lineage’s operating and financing leases, as applicable.
Supplemental
cash flow information related to leases was as follows (in thousands):
Schedule of Supplemental Cash Flow Information Related to Leases
|
|
Year
Ended December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Cash paid for amounts included in the measurement of lease liabilities:
|
|
|
|
|
|
|
|
|
Operating cash flows from operating leases
|
|
$
|
1,356
|
|
|
$
|
1,364
|
|
Operating cash flows from financing leases
|
|
|
20
|
|
|
|
28
|
|
Financing cash flows from financing leases
|
|
|
26
|
|
|
|
30
|
|
|
|
|
|
|
|
|
|
|
Right-of-use assets obtained in exchange for lease obligations:
|
|
|
|
|
|
|
|
|
Operating leases
|
|
|
1,047
|
|
|
|
738
|
|
Financing leases
|
|
|
-
|
|
|
|
-
|
|
Supplemental
balance sheet information related to leases was as follows (in thousands, except lease term and discount rate):
Schedule of Supplemental Balance Sheet Information Related to Leases
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Operating leases
|
|
|
|
|
|
|
|
|
Right-of-use assets, net
|
|
$
|
2,916
|
|
|
$
|
4,666
|
|
|
|
|
|
|
|
|
|
|
Right-of-use lease liabilities, current
|
|
$
|
746
|
|
|
$
|
1,190
|
|
Right-of-use lease liabilities, noncurrent
|
|
|
2,514
|
|
|
|
3,868
|
|
Total operating lease liabilities
|
|
$
|
3,260
|
|
|
$
|
5,058
|
|
|
|
|
|
|
|
|
|
|
Financing leases
|
|
|
|
|
|
|
|
|
Property and equipment, gross
|
|
$
|
79
|
|
|
$
|
96
|
|
Accumulated depreciation
|
|
|
(65
|
)
|
|
|
(48
|
)
|
Property and equipment, net
|
|
$
|
14
|
|
|
$
|
48
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
$
|
16
|
|
|
$
|
33
|
|
Long-term liabilities
|
|
|
26
|
|
|
|
77
|
|
Total finance lease liabilities
|
|
$
|
42
|
|
|
$
|
110
|
|
|
|
|
|
|
|
|
|
|
Weighted average remaining lease term
|
|
|
|
|
|
|
|
|
Operating leases
|
|
|
4.2
years
|
|
|
|
4.1
years
|
|
Finance leases
|
|
|
2.4
years
|
|
|
|
3.4
years
|
|
Weighted average discount rate
|
|
|
|
|
|
|
|
|
Operating leases
|
|
|
8.0
|
%
|
|
|
9.1
|
%
|
Finance leases
|
|
|
10.0
|
%
|
|
|
10.0
|
%
|
Future
minimum lease commitments are as follows (in thousands):
Schedule of Future Minimum Lease Commitments
|
|
Operating
Leases
|
|
|
Finance
Leases
|
|
Year Ending December 31,
|
|
|
|
|
|
|
|
|
2021
|
|
$
|
957
|
|
|
$
|
19
|
|
2022
|
|
|
912
|
|
|
|
19
|
|
2023
|
|
|
480
|
|
|
|
8
|
|
2024
|
|
|
454
|
|
|
|
-
|
|
2025
|
|
|
442
|
|
|
|
-
|
|
Thereafter
|
|
|
628
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Total lease payments
|
|
$
|
3,873
|
|
|
$
|
46
|
|
Less imputed interest
|
|
|
(613
|
)
|
|
|
(4
|
)
|
Total
|
|
$
|
3,260
|
|
|
$
|
42
|
|
Research
and Option Agreement
On
January 5, 2019, Lineage and Orbit Biomedical Limited (“Orbit”) entered into a Research and Option Agreement, which
was assigned by Orbit to Gyroscope Therapeutics, Limited (“Gyroscope”) and amended on May 7, 2019, January 30, 2020,
May 1, 2020 and September 4, 2020 (the “Gyroscope Agreement”). As amended, the Gyroscope Agreement provides Lineage
access to Gyroscope’s vitrectomy-free subretinal injection device (the “Orbit Device”) as a means of delivering
OpRegen in Lineage’s ongoing Phase 1/2a clinical trial through the earlier of: (i) December 1, 2020; or (ii) or treatment
of three additional patients with the Orbit Device between September 4, 2020 and December 1, 2020 (the “Access Period”).
Following the Access Period, Lineage also has an exclusive right to negotiate a definitive agreement to distribute and sell the
Orbit Device for the subretinal delivery of RPE cells for the treatment of dry AMD, which was extended through May 2021 (the “Option
Period”). Pursuant to the terms of the Gyroscope Agreement, Lineage paid access fees totaling $2.5
million: (i) $1.25
million in January 2019 upon execution of the Gyroscope Agreement; and (ii) $1.25
million in August 2019 upon completion of certain collaborative research activities using the Gyroscope technology for
the OpRegen Phase 1/2a clinical trial. These access fees of $2.5
million were amortized on a straight-line basis throughout 2019 and included in research and development expenses. Lineage
also agreed to reimburse Gyroscope for costs of consumables, training services, travel costs and other out of pocket expenses
incurred by Gyroscope for performing services under the Gyroscope Agreement. In January 2020, Lineage agreed to pay an additional
$0.5
million to extend the Access Period to July 5, 2020, $0.2
million of which was paid in February 2020 and $0.3
million of which was paid in November 2020. The Access Period was subsequently extended at no cost as described above.
In February 2021, Lineage paid $0.5
million to extend the Option Period.
Litigation
– General
Lineage
is subject to various claims and contingencies in the ordinary course of its business, including those related to litigation,
business transactions, employee-related matters, and others. When Lineage is aware of a claim or potential claim, it assesses
the likelihood of any loss or exposure. If it is probable that a loss will result and the amount of the loss can be reasonably
estimated, Lineage will record a liability for the loss. If the loss is not probable or the amount of the loss cannot be reasonably
estimated, Lineage discloses the claim if the likelihood of a potential loss is reasonably possible and the amount involved could
be material. Lineage is not aware of any claims likely to have a material adverse effect on its financial condition or results
of operations.
On
February 19, 2019, a putative shareholder class action lawsuit was filed (captioned Lampe v. Asterias Biotherapeutics, Inc.
et al., Case No. RG19007391) in the Superior Court of the State of California, County of Alameda challenging the Asterias
Merger. On March 1, 2019, Asterias made certain amendments and supplements to its public disclosures regarding the Asterias Merger
(the “Supplemental Disclosures”). On May 3, 2019, an amended class action complaint (the “Amended Complaint”)
was filed. The Amended Complaint named Lineage, Patrick Merger Sub, Inc., the Asterias board of directors, one member of Lineage’s
board of directors, and certain stockholders of both Lineage and Asterias. The action was brought by two purported stockholders
of Asterias, on behalf of a putative class of Asterias stockholders, and asserted breach of fiduciary duty and aiding and abetting
claims under Delaware law. The Amended Complaint alleged, among other things, that the process leading up to the Asterias Merger
was conflicted and inadequate, and that the proxy statement filed by Asterias with the Commission omitted certain material information,
which allegedly rendered the information disclosed materially misleading. The Amended Complaint sought, among other things, that
a class be certified, the recovery of monetary damages, and attorneys’ fees and costs.
On
June 3, 2019, defendants filed demurrers to the Amended Complaint. On August 13, 2019, the parties submitted a stipulation to
the court seeking dismissal of the action with prejudice as to the named Plaintiffs and without prejudice as to the unnamed putative
class members, and disclosing to the court the parties’ agreement to resolve, for $200,000, Plaintiffs’ claim for
an award of attorneys’ fees and expenses in connection with the purported benefit conferred on Asterias stockholders by
the Supplemental Disclosures. The court granted the stipulation and dismissed the action August 14, 2019. Lineage continues to
believe that the claims and allegations in the action lack merit, but believed that it was in Lineage’s shareholders’
best interest for the action to be dismissed and to resolve the fee claim in a timely manner without additional costly litigation
expenses.
On
October 14, 2019, another putative class action lawsuit was filed challenging the Asterias Merger. This action (captioned Ross
v. Lineage Cell Therapeutics, Inc., et al., C.A. No. 2019-0822) was filed in Delaware Chancery Court and names Lineage, the
Asterias board of directors, one member of Lineage’s board of directors, and certain stockholders of both Lineage and Asterias
as defendants. The action was brought by a purported stockholder of Asterias, on behalf of a putative class of Asterias stockholders,
and asserts breach of fiduciary duty and aiding and abetting claims under Delaware law. The complaint alleges, among other things,
that the process leading up to the Asterias Merger was conflicted, that the Asterias Merger consideration was inadequate, and
that the proxy statement filed by Asterias with the Commission omitted certain material information, which allegedly rendered
the information disclosed materially misleading. The complaint seeks, among other things, that a class be certified, the recovery
of monetary damages, and attorneys’ fees and costs. On December 20, 2019, the defendants moved to dismiss the complaint.
On February 10, 2020, the plaintiff filed an opposition. Defendants filed their replies on March 13, 2020. On June 23, 2020, a
hearing on the motions to dismiss occurred. On September 21, 2020, the Chancery Court denied the motion to dismiss as to Lineage
and certain members of the Asterias board of directors, and it granted the motion to dismiss as to all other defendants. On October
30, 2020, the remaining defendants filed an answer to the complaint.
Lineage
believes the allegations in the action lack merit and intends to vigorously defend the claims asserted. It is impossible at this
time to assess whether the outcome of this proceeding will have a material adverse effect on Lineage’s consolidated results
of operations, cash flows or financial position. Therefore, in accordance with ASC 450, Contingencies, Lineage has not
recorded any accrual for a contingent liability associated with this legal proceeding based on its belief that a liability, while
possible, is not probable nor estimable, and any range of potential contingent liability amounts cannot be reasonably estimated
at this time. Lineage records legal expenses as incurred.
Employment
Contracts
Lineage
has entered into employment agreements with certain executive officers. Under the provisions of the agreements, Lineage may be
required to incur severance obligations for matters relating to changes in control, as defined in the agreements, and involuntary
terminations.
Indemnification
In
the normal course of business, Lineage may provide indemnifications of varying scope under Lineage’s agreements with other
companies or consultants, typically Lineage’s clinical research organizations, investigators, clinical sites, suppliers
and others. Pursuant to these agreements, Lineage will generally agree to indemnify, hold harmless, and reimburse the indemnified
parties for losses and expenses suffered or incurred by the indemnified parties arising from claims of third parties in connection
with the use or testing of Lineage’s products and services. Indemnification provisions could also cover third party infringement
claims with respect to patent rights, copyrights, or other intellectual property pertaining to Lineage products and services.
The term of these indemnification agreements will generally continue in effect after the termination or expiration of the particular
research, development, services, or license agreement to which they relate. The potential future payments Lineage could be required
to make under these indemnification agreements will generally not be subject to any specified maximum amount. Historically, Lineage
has not been subject to any claims or demands for indemnification. Lineage also maintains various liability insurance policies
that limit Lineage’s financial exposure. As a result, Lineage believes the fair value of these indemnification agreements
is minimal. Accordingly, Lineage has not recorded any liabilities for these agreements as of December 31, 2020 and 2019.
Second
Amendment to Clinical Trial and Option Agreement and License Agreement with Cancer Research UK
On
May 6, 2020, Lineage and its wholly owned subsidiary Asterias entered into a Second Amendment to Clinical Trial and Option Agreement
(the “CTOA Amendment”) with Cancer Research UK (“CRUK”) and Cancer Research Technology Limited (“CRT”),
which amends the Clinical Trial and Option Agreement entered into between Asterias, CRUK and CRT dated September 8, 2014, as amended
September 8, 2014. Pursuant to the CTOA Amendment, Lineage assumed all obligations of Asterias and exercised early its option
to acquire data generated in the Phase 1 clinical trial of VAC2 in non-small cell lung cancer being conducted by CRUK. CRUK will
continue conducting the VAC2 study.
Lineage
and CRT effectuated the option by simultaneously entering into a license agreement (the “License Agreement”) pursuant
to which Lineage agreed to pay the previously agreed signature fee of £1,250,000 (approximately $1.6 million). In consideration
of Lineage’s agreement to exercise the option prior to completion of the study, the parties agreed to defer the signature
fee as follows: £500,000 in September 2020, £500,000 in January 2021 and £250,000 in April 2021. For the primary
licensed product for the first indication, the License Agreement provides for milestone fees of up to £8,000,000 based upon
initiation of a Phase 3 clinical trial and the filing for regulatory approval and up to £22,500,000 in sales-based milestones
payments. Additional milestone fees and sales-based milestone payments would be payable for other products or indications, and
mid-single-digit royalty payments are payable on sales of commercial products.
Either
party may terminate the License Agreement for the uncured material breach of the other party. CRT may terminate the License Agreement
in the case of Lineage’s insolvency or if Lineage ceases all development and commercialization of all products under the
License Agreement.
Second
Amended and Restated License Agreement
On
June 15, 2017, Cell Cure entered into a Second Amended and Restated License Agreement (the “License Agreement”) with
Hadasit Medical Research Services and Development Ltd. (“Hadasit”), the commercial arm and a wholly owned subsidiary
of Hadassah Medical Organization. Pursuant to the License Agreement, Hadasit granted Cell Cure an exclusive, worldwide, royalty
bearing license (with the right to grant sublicenses) in its intellectual property portfolio of materials and technology related
to human stem cell derived photoreceptor cells and retinal pigment epithelial cells (the “Licensed IP”), to use, commercialize
and exploit any part thereof, in any manner whatsoever in the fields of the development and exploitation of (i) human stem cell
derived photoreceptor cells, solely for use in cell therapy for the diagnosis, amelioration, prevention and treatment of eye disorders,
and (ii) human stem cell derived retinal pigment epithelial cells, solely for use in cell therapy for the diagnosis, amelioration,
prevention and treatment of eye disorders.
As
consideration for the Licensed IP, Cell Cure will pay a small one-time lump sum payment, a royalty in the mid-single digits of
net sales from sales of Licensed IP by any invoicing entity, and a royalty of 21.5% of sublicensing receipts. In addition, Cell
Cure will pay Hadasit an annual minimal non-refundable royalty, which will become due and payable the first January 1 following
the completion of services to Cell Cure by a research laboratory.
Cell
Cure will pay Hadasit non-refundable milestone payments upon the recruitment of the first patient for the first Phase 2b clinical
trial, upon the enrollment of the first patient in the first Phase 3 clinical trials, upon delivery of the report for the first
Phase 3 clinical trials, upon the receipt of an NDA or marketing approval in the European Union, whichever is the first to occur,
and upon the first commercial sale in the United States or European Union, whichever is the first to occur. Such milestones, in
the aggregate, may be up to $3.5 million. As of December 31, 2020, Cell Cure had not accrued any milestone payments under the
License Agreement.
The
License Agreement terminates upon the expiration of Cell Cure’s obligation to pay royalties for all licensed products, unless
earlier terminated. In addition to customary termination rights of both parties, Hadasit may terminate the License Agreement if
Cell Cure fails to continue the clinical development of the Licensed IP or fails to take actions to commercialize or sell the
Licensed IP over any consecutive 12 month period. The License Agreement also contains mutual confidentiality obligations of Cell
Cure and Hadasit, and indemnification obligations of Cell Cure.
Royalty
obligations and license fees
Lineage
and its subsidiaries or affiliates are parties to certain licensing agreements with research institutions, universities and other
parties for the rights to use those licenses and other intellectual property in conducting research and development activities.
These licensing agreements provide for the payment of royalties by Lineage or the applicable party to the agreement on future
product sales, if any. In addition, in order to maintain these licenses and other rights during the product development, Lineage
or the applicable party to the contract must comply with various conditions including the payment of patent related costs and
annual minimum maintenance fees. Annual minimum maintenance fees are expected to be approximately $30,000 to $60,000 per year.
Grants
Under
the terms of the grant agreement between Cell Cure and Israel Innovation Authority (“IIA”) (formerly the Office of
the Chief Scientist of Israel) of the Ministry of Economy and Industry, for the development of OpRegen®, Cell Cure
will be required to pay royalties on future product sales, if any, up to the amounts received from the IIA, plus interest indexed
to LIBOR. Cell Cure’s research and product development activities under the grant are subject to substantial risks and uncertainties
and performed on a best efforts basis. As a result, Cell Cure is not required to make any payments under the grant agreement unless
it successfully commercializes OpRegen®. Accordingly, pursuant to ASC 730-20, the Cell Cure grant is considered
a contract to perform research and development services for others and grant revenue is recognized as the related research and
development expenses are incurred (see Note 2).
Israeli
law pertaining to such government grants contain various conditions, including substantial penalties and restrictions on the transfer
of intellectual property, or the manufacture, or both, of products developed under the grant outside of Israel, as defined by
the IIA.
15.
Employee Benefit Plan
We
have a defined contribution 401(k) plan for all employees. Under the terms of the plan, employees may make voluntary contributions
as a percentage or defined amount of compensation. We provide a safe harbor contribution of up to 5.0% of the employee’s
compensation, not to exceed eligible limits, and subject to employee participation. For the years ended December 31, 2020 and
2019, we incurred approximately $149,000 and $287,000, respectively, in expenses related to the safe harbor contribution.
16.
Segment Information
Lineage’s
executive management team, as a group, represents the entity’s chief operating decision makers. Lineage’s executive
management team views Lineage’s operations as one segment that includes the research and development of therapeutic products
for retinal diseases, neurological diseases and disorders and oncology. As a result, the financial information disclosed materially
represents all of the financial information related to Lineage’s sole operating segment.
17.
Enterprise-Wide Disclosures
Geographic
Area Information
The
following table presents consolidated revenues, including license fees, royalties, grant income, and other revenues, disaggregated
by geography, based on the billing addresses of customers, or in the case of grant revenues based on where the governmental entities
that fund the grant are located (in thousands).
Schedule of Geographic Area Information
|
|
Year Ended December 31,
|
|
Geographic Area
|
|
2020
|
|
|
2019
|
|
United States
|
|
$
|
1,160
|
|
|
$
|
2,092
|
|
Foreign (1)
|
|
|
666
|
|
|
|
1,423
|
|
Total revenues
|
|
$
|
1,826
|
|
|
$
|
3,515
|
|
(1)
|
Foreign
revenues are primarily generated from grants in Israel.
|
The
composition of Lineage’s long-lived assets, consisting of plant and equipment, net, between those in the United States and
in foreign countries, as of December 31, 2020 and 2019, is set forth below (in thousands):
|
|
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
Domestic
|
|
$
|
1,035
|
|
|
$
|
3,654
|
|
Foreign (1)
|
|
|
4,595
|
|
|
|
4,521
|
|
Total
|
|
$
|
5,630
|
|
|
$
|
8,175
|
|
(1)
|
Assets
in foreign countries principally include laboratory equipment and leasehold improvements in Israel.
|
Major
Sources of Revenues
The
following table presents Lineage’s consolidated revenues disaggregated by source (in thousands).
Schedule
of Revenues Disaggregated by Source
|
|
Year Ended December 31,
|
|
|
|
2020
|
|
|
2019
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
Grant revenue
|
|
$
|
1,053
|
|
|
$
|
2,037
|
|
Royalties from product sales and license fees
|
|
|
773
|
|
|
|
1,221
|
|
Sale of research products and services
|
|
|
-
|
|
|
|
257
|
|
Total revenues
|
|
$
|
1,826
|
|
|
$
|
3,515
|
|
Prepaid
expenses and other current assets at December 31, 2020 includes $0.2
million of receivables related to royalties
from product sales and license fees, and $0.3 million of receivables related to cash in transit for sales of ATM Shares in
2020 that settled in 2021.
The
following table shows Lineage’s major sources of revenues, as a percentage of total revenues, that were recognized during
the years ended December 31, 2020 and 2019:
Schedule of Sources of Revenues
|
|
Year Ended December 31,
|
|
Sources of Revenues
|
|
2020
|
|
|
2019
|
|
NIH grant income
|
|
|
21.2
|
%
|
|
|
17.5
|
%
|
IIA grant income (Cell Cure Neurosciences, Ltd, Israel)
|
|
|
36.5
|
%
|
|
|
40.5
|
%
|
Royalties, licenses, subscriptions, advertising and other
|
|
|
42.3
|
%
|
|
|
34.7
|
%
|
Sale of research products
|
|
|
-
|
%
|
|
|
7.3
|
%
|
18.
Selected Quarterly Financial Information (UNAUDITED,
in thousands, except per share data)
Lineage
has derived this data from the unaudited consolidated interim financial statements that, in Lineage’ s opinion, have been
prepared on substantially the same basis as the audited consolidated financial statements contained herein and include all normal
recurring adjustments necessary for a fair presentation of the financial information for the periods presented. These unaudited
consolidated quarterly results should be read in conjunction with the consolidated financial statements and notes thereto included
herein. The consolidated operating results in any quarter are not necessarily indicative of the consolidated results that may
be expected for any future period.
Schedule of Selected Quarterly Financial Information
Year Ended December 31, 2020
|
|
First
Quarter
|
|
|
Second
Quarter
|
|
|
Third
Quarter
|
|
|
Fourth
Quarter
|
|
Revenues, net
|
|
$
|
514
|
|
|
|
386
|
|
|
|
571
|
|
|
|
355
|
|
Operating expenses
|
|
|
7,858
|
|
|
|
6,713
|
|
|
|
7,194
|
|
|
|
6,123
|
|
Loss from operations
|
|
|
(7,438
|
)
|
|
|
(6,402
|
)
|
|
|
(6,725
|
)
|
|
|
(5,882
|
)
|
Net income (loss) attributable to Lineage
|
|
|
(8,399
|
)
|
|
|
(6,522
|
)
|
|
|
(7,760
|
)
|
|
|
2,032
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share
|
|
$
|
(0.06
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(0.05
|
)
|
|
$
|
0.01
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues, net
|
|
$
|
928
|
|
|
|
779
|
|
|
|
567
|
|
|
|
1,241
|
|
Operating expenses
|
|
|
13,621
|
|
|
|
11,493
|
|
|
|
8,875
|
|
|
|
7,990
|
|
Loss from operations
|
|
|
(12,761
|
)
|
|
|
(10,821
|
)
|
|
|
(8,422
|
)
|
|
|
(6,872
|
)
|
Net income (loss) attributable to Lineage
|
|
|
39,310
|
|
|
|
(30,032
|
)
|
|
|
(16,505
|
)
|
|
|
(4,482
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share
|
|
$
|
0.30
|
|
|
$
|
(0.20
|
)
|
|
$
|
(0.11
|
)
|
|
$
|
(0.03
|
)
|
Quarterly
and year-to-date computations of net income (loss) per share amounts are calculated using the respective period weighted average
shares outstanding. Therefore, the sum of the per share amounts for the quarters may not agree with the per share amounts for
the year.
19.
Subsequent Events
Sale
of OncoCyte Shares
In
January and February 2021, Lineage sold 2.5 million shares of OncoCyte common stock for gross proceeds of $10.1 million. After
these sales, Lineage owns 1,122,401 shares of OncoCyte common stock, which has a value of $4.2 million as of March 5, 2021.
Sales
of Lineage Shares Under the ATM
In
the first quarter of 2021 through March 5, 2021, Lineage sold 7,941,122 common
shares of Lineage ATM Shares for gross and net proceeds of $19.9 million
and $19.3 million,
respectively (in each case, which includes $0.3 million
of proceeds in transit related to 2020 sales that settled in 2021).
See Note 11 for additional information. On March 5, 2021, Lineage filed a prospectus supplement with the SEC in
connection with the offer and sale of an additional $25 million
of ATM Shares.
Research
and Option Agreement
In
February 2021, Lineage extended the Option Period with Gyroscope for $0.5 million for an additional three months. See Note 14
for additional information.