Item 1. Financial Statements
Item
1. Financial Statements
HARROW
HEALTH, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except share data)
2020
2019
September 30,
December 31,
2020
2019
(unaudited)
ASSETS
Current assets
Cash
and cash equivalents, including restricted cash of $ 200
$ 5,727
$ 4,949
Investment in Eton
Pharmaceuticals
27,650
25,200
Accounts receivable,
net
2,195
2,009
Inventories
3,974
3,301
Prepaid
expenses and other current assets
1,431
1,308
Total current assets
40,977
36,767
Property, plant and equipment, net
4,773
5,375
Operating lease right-of-use assets
6,945
6,559
Intangible assets, net
1,958
2,337
Investment in Surface Ophthalmics
2,053
3,747
Investment in Melt Pharmaceuticals
2,432
3,968
Goodwill
332
332
TOTAL
ASSETS
$ 59,470
$ 59,085
LIABILITIES AND
STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable
and accrued expenses
$ 5,691
$ 7,702
Accrued payroll
and related liabilities
3,692
2,117
Deferred revenue
and customer deposits
63
57
Current portion
of paycheck protection program loan payable
1,138
-
Current portion
of loan payable, net of unamortized debt discount
2,612
1,772
Current portion
of operating lease liabilities
579
629
Current
portion of finance lease obligations
7
7
Total current liabilities
13,782
12,284
Operating lease liabilities, net of
current portion
6,780
6,338
Finance lease obligations, net of current
portion
20
26
Accrued expenses, net of current portion
800
800
Paycheck protection program loan payable,
net of current portion
829
-
Loan payable,
net of current portion and unamortized debt discount
12,331
12,219
TOTAL
LIABILITIES
34,542
31,667
COMMITMENTS AND CONTINGENCIES
-
-
STOCKHOLDERS’ EQUITY
Common stock, $ 0.001 par value, 50,000,000
shares authorized, 25,652,169 and 25,526,931 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively
26
26
Additional paid-in
capital
103,798
101,728
Accumulated
deficit
( 78,549 )
( 74,043 )
TOTAL HARROW HEALTH
STOCKHOLDERS’ EQUITY
25,275
27,711
Noncontrolling
interests
( 347 )
( 293 )
TOTAL
STOCKHOLDERS’ EQUITY
24,928
27,418
TOTAL
LIABILITIES AND EQUITY
$ 59,470
$ 59,085
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
3
HARROW
HEALTH, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In
thousands, except for share and per share data)
2020
2019
2020
2019
For the
For the
For the
For the
Three Months Ended
Three Months Ended
Nine Months Ended
Nine Months Ended
September 30,
September 30,
September 30,
September 30,
2020
2019
2020
2019
Revenues:
Product
sales, net
$ 14,385
$ 12,748
$ 34,244
$ 38,540
Other
revenues
14
7
32
21
Total revenues
14,399
12,755
34,276
38,561
Cost of sales
( 3,696 )
( 4,061 )
( 10,526 )
( 13,184 )
Gross profit
10,703
8,694
23,750
25,377
Operating expenses:
Selling, general
and administrative
8,436
8,608
23,806
25,399
Research and development
670
444
1,822
1,659
Impairment
of long-lived assets
-
4,040
363
4,040
Total operating
expenses
9,106
13,092
25,991
31,098
Income (loss)
from operations
1,597
( 4,398 )
( 2,241 )
( 5,721 )
Other income (expense):
Interest expense,
net
( 498 )
( 620 )
( 1,563 )
( 1,939 )
Investment (loss)
gain from Melt Pharmaceuticals, net
( 300 )
( 682 )
( 1,536 )
4,517
Investment loss
from Surface Ophthalmics, net
( 756 )
( 400 )
( 1,694 )
( 904 )
Investment gain
(loss) from Eton Pharmaceuticals, net
8,575
( 5,530 )
2,450
700
Other
income, net
5
-
24
630
Total other income (expense), net
7,026
( 7,232 )
( 2,319 )
3,004
Income (loss) before income taxes
8,623
( 11,630 )
( 4,560 )
( 2,717 )
Income
tax benefit, net
-
-
-
-
Total net income (loss) including noncontrolling
interests
8,623
( 11,630 )
( 4,560 )
( 2,717 )
Net
loss attributable to noncontrolling interests
15
161
54
228
Net income (loss)
attributable to Harrow Health, Inc.
$ 8,638
$ ( 11,469 )
$ ( 4,506 )
$ ( 2,489 )
Basic net income
(loss) per share of common stock
$ 0.33
$ ( 0.45 )
$ ( 0.17 )
$ ( 0.10 )
Diluted net income
(loss) per share of common stock
$ 0.32
$ ( 0.45 )
$ ( 0.17 )
$ ( 0.10 )
Weighted
average number of shares of common stock outstanding,
basic
25,921,573
25,583,998
25,880,554
25,205,215
Weighted
average number of shares of common stock outstanding,
diluted
27,090,060
25,583,998
25,880,554
25,205,215
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
4
HARROW
HEALTH, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
For
the Three and Nine Months Ended September 30, 2020 and 2019
(In
thousands, except for share data)
Shares
Value
Capital
Deficit
Equity
Interest
Equity
Total
Common
Stock
Additional
Harrow
Health, Inc.
Total
Total
Par
Paid-in
Accumulated
Stockholders’
Noncontrolling
Stockholders’
Shares
Value
Capital
Deficit
Equity
Interest
Equity
Balance at June 30, 2019
25,138,958
$ 25
$ 100,271
$ ( 65,231 )
$ 35,065
$ ( 67 )
$ 34,998
Issuance of common stock in connection
with:
Exercise of warrants
25,135
-
-
-
-
-
-
Exercise of employee
stock-based options, net of tax withholding
4,748
-
( 44 )
-
( 44 )
-
( 44 )
Stock-based payment
for services provided
-
-
75
-
75
-
75
Stock-based compensation expense
-
-
328
-
328
-
328
Vesting of RSUs
Vesting of RSUs, shares
Net loss
-
-
-
( 11,469 )
( 11,469 )
( 161 )
( 11,630 )
Balance at September 30, 2019
25,168,841
$ 25
$ 100,630
$ ( 76,700 )
$ 23,955
$ ( 228 )
$ 23,727
Total
Common
Stock
Additional
Harrow
Health, Inc.
Total
Total
Par
Paid-in
Accumulated
Stockholders’
Noncontrolling
Stockholders’
Shares
Value
Capital
Deficit
Equity
Interest
Equity
Balance at June 30, 2020
25,649,171
$ 26
$ 102,889
$ ( 87,187 )
$ 15,728
$ ( 332 )
$ 15,396
Issuance of common stock in connection
with:
Exercise of employee
stock-based options, net of tax withholding
2,998
-
( 8 )
-
( 8 )
-
( 8 )
Stock-based compensation
expense
-
-
917
-
917
-
917
Net income (loss)
-
-
-
8,638
8,638
( 15 )
8,623
Balance at September 30, 2020
25,652,169
$ 26
$ 103,798
$ ( 78,549 )
$ 25,275
$ ( 347 )
$ 24,928
Total
Common
Stock
Additional
Harrow
Health, Inc.
Total
Total
Par
Paid-in
Accumulated
Stockholders’
Noncontrolling
Stockholders’
Shares
Value
Capital
Deficit
Equity
Interest
Equity
Balance at December 31, 2018
24,339,610
$ 24
$ 98,938
$ ( 74,211 )
$ 24,751
$ -
$ 24,751
Issuance of common stock in connection
with:
Exercise of warrants
788,528
1
178
-
179
-
179
Exercise of employee
stock-based options, net of tax withholding
25,703
-
( 44 )
-
( 44 )
-
( 44 )
Stock-based payment
for services provided
15,000
-
150
-
150
-
150
Stock-based compensation expense
-
-
1,408
-
1,408
-
1,408
Net loss
-
-
-
( 2,489 )
( 2,489 )
( 228 )
( 2,717 )
Balance at September 30, 2019
25,168,841
$ 25
$ 100,630
$ ( 76,700 )
$ 23,955
$ ( 228 )
$ 23,727
Total
Common
Stock
Additional
Harrow
Health, Inc.
Total
Total
Par
Paid-in
Accumulated
Stockholders’
Noncontrolling
Stockholders’
Shares
Value
Capital
Deficit
Equity
Interest
Equity
Balance at December 31, 2019
25,526,931
$ 26
$ 101,728
$ ( 74,043 )
$ 27,711
$ ( 293 )
$ 27,418
Issuance of common stock in connection
with:
Exercise of employee
stock-based options, net of tax withholding
3,251
-
( 8 )
-
( 8 )
-
( 8 )
Vesting of RSUs
91,987
-
-
-
-
-
-
Stock-based payment
for services provided
30,000
-
83
-
83
-
83
Stock-based compensation expense
-
-
1,995
-
1,995
-
1,995
Net loss
-
-
-
( 4,506 )
( 4,506 )
( 54 )
( 4,560 )
Balance at September 30, 2020
25,652,169
$ 26
$ 103,798
$ ( 78,549 )
$ 25,275
$ ( 347 )
$ 24,928
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
5
HARROW
HEALTH, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In
thousands)
2020
2019
For the
Nine Months Ended
September
30,
2020
2019
CASH FLOWS FROM OPERATING ACTIVITIES
Net
loss (including noncontrolling interests)
$ ( 4,560 )
$ ( 2,717 )
Adjustments to reconcile
net loss to net cash used in operating activities:
Depreciation and
amortization of property, plant and equipment
1,377
1,365
Amortization of
intangible assets
127
175
Amortization of
operating lease right-of-use assets
550
386
Amortization of
debt issuance costs and discount
354
394
Provision for bad
debt expense
221
-
Investment gain
from Eton, net
( 2,450 )
( 700 )
Investment loss
from Surface, net
1,694
904
Investment loss
(gain) from Melt, net
1,536
( 4,517 )
Loss on sale and
disposal of equipment
5
-
Interest paid-in-kind
on loan payable
348
-
Impairment of long-lived
assets
363
4,013
Stock-based payment
of consulting services
83
150
Stock-based compensation
1,995
1,408
Changes in assets
and liabilities:
Accounts receivable,
net of provision for bad debt expense
( 407 )
( 901 )
Inventories
( 673 )
( 1,413 )
Prepaid expenses
and other current assets
( 123 )
( 528 )
Accounts payable
and accrued expenses
( 2,555 )
1,721
Accrued payroll
and related liabilities
1,575
( 371 )
Deferred
revenue and customer deposits
6
( 71 )
NET CASH USED
IN OPERATING ACTIVITIES
( 534 )
( 702 )
CASH FLOWS FROM INVESTING ACTIVITIES
Proceeds on sale
and disposal of assets
-
4
Investment in patent
and trademark assets
( 111 )
( 279 )
Purchases
of property, plant and equipment
( 780 )
( 589 )
NET CASH USED
IN INVESTING ACTIVITIES
( 891 )
( 864 )
CASH FLOWS FROM FINANCING ACTIVITIES
Payments on finance
lease obligations
( 6 )
( 744 )
Proceeds from SWK
debt
1,000
-
Principal payments
on loan payable
( 750 )
( 750 )
Payments of costs
related to amendment of note payable
-
( 282 )
Net proceeds from
Payroll Protection Program loan payable
1,967
-
Net
proceeds from exercise of warrants and stock options, net of taxes remitted for RSU and options
( 8 )
135
NET CASH PROVIDED
BY (USED IN) FINANCING ACTIVITIES
2,203
( 1,641 )
NET CHANGE IN CASH, CASH EQUIVALENTS
AND RESTRICTED CASH
778
( 3,207 )
CASH, CASH EQUIVALENTS
AND RESTRICTED CASH, beginning of period
4,949
6,838
CASH, CASH EQUIVALENTS
AND RESTRICTED CASH, end of period
$ 5,727
$ 3,631
RECONCILIATION OF CASH, CASH EQUIVALENTS
AND RESTRICTED CASH
Cash and cash equivalents
$ 5,527
$ 3,431
Restricted cash
200
200
CASH, CASH EQUIVALENTS
AND RESTRICTED CASH AT END OF PERIOD
$ 5,727
$ 3,631
SUPPLEMENTAL DISCLOSURE OF CASH FLOW
INFORMATION:
Cash paid for
income taxes
$ -
$ 11
Cash paid for
interest
$ 1,222
$ 1,546
SUPPLEMENTAL DISCLOSURES OF NON-CASH
INVESTING AND FINANCING ACTIVITIES:
New and revaluation
of right-of-use asset obtained in exchange for lease obligation
$ 936
$ -
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
6
HARROW
HEALTH, INC.
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
the three and nine months ended September 30, 2020 and 2019
(Dollar
amounts in thousands, except share and per share data)
NOTE
1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
Company
and Background
Harrow
Health, Inc. (together with its subsidiaries, partially owned companies and royalty arrangements unless the context indicates
or otherwise requires, the “Company” or “Harrow”) specializes in the development, production and sale
of innovative medications that offer unique competitive advantages and serve unmet needs in the marketplace through its subsidiaries
and deconsolidated companies. The Company owns one of the nation’s leading ophthalmology-focused pharmaceutical businesses,
ImprimisRx. In addition to wholly owning ImprimisRx, the Company also has equity positions in Eton Pharmaceuticals, Inc. (“Eton”),
Surface Ophthalmics, Inc. (“Surface”), and Melt Pharmaceuticals, Inc. (“Melt”), all companies that
began as subsidiaries of Harrow. More recently, the Company founded drug development subsidiaries Mayfield Pharmaceuticals, Inc.
(“Mayfield”) and Stowe Pharmaceuticals, Inc. (“Stowe”), among others. In 2020, Harrow created Visionology,
Inc., which intends to launch an online eye health platform business. Harrow also owns royalty rights in various drug candidates
being developed by Surface, Melt and Mayfield. The Company intends to continue to create, and hold equity and royalty rights in,
new businesses that commercialize drug candidates that are internally developed or otherwise acquired or licensed from third parties.
Basis
of Presentation
The
Company has prepared the accompanying unaudited condensed consolidated financial statements in accordance with accounting principles
generally accepted in the United States of America (“GAAP”) for interim financial information and in accordance with
the rules and regulations of the U.S. Securities and Exchange Commission. Accordingly, they do not include all of the information
and footnotes required by GAAP for audited financial statements. In the opinion of management, all adjustments (consisting of
only normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the
three and nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the year
ending December 31, 2020 or for any other period. For further information, refer to the Company’s audited consolidated financial
statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019.
The
accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries,
as well as Mayfield ( 79 % majority controlled) and Stowe ( 70 % majority controlled) each subsidiaries of Harrow as of September
30, 2020. The remaining 21 % of Mayfield is owned by Elle Pharmaceutical, LLC (“Elle”), TGV-Health, LLC and its affiliated
entities (collectively “TGV”) or other consultants. Mayfield was organized to develop women’s health-focused
drug candidates. The remaining 30 % of Stowe is owned by TGV. Stowe was organized to develop ophthalmic drug candidates. All inter-company
accounts and transactions have been eliminated in consolidation.
Harrow
consolidates entities in which it has a controlling financial interest. We consolidate subsidiaries in which we hold and/or control,
directly or indirectly, more than 50% of the voting rights. All intercompany accounts and transactions have been eliminated in
consolidation.
The
condensed consolidated balance sheets at September 30, 2020 and December 31, 2019 and the condensed consolidated statements of
operations, stockholders’ equity and cash flows for the periods ended September 30, 2020 and 2019 include our accounts and
those of our wholly owned subsidiaries as well as Mayfield and Stowe.
7
Risks,
Uncertainties and Liquidity
The
Company is subject to risks and uncertainties as a result of the COVID-19 pandemic. On March 18, 2020, the Centers for Medicare
& Medicaid Services (“CMS”) released guidance for U.S. healthcare providers to limit all elective medical procedures
in order to conserve personal protective equipment and limit exposure to COVID-19 during the pendency of the pandemic. In addition
to limiting elective medical procedures, many hospitals and other healthcare providers have strictly limited access to their facilities
during the pandemic. The COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains and healthcare
delivery, led to social distancing recommendations, stay-at-home orders and other restrictive measures, and created significant
volatility in financial markets.
Many
of the Company’s customers use its drugs in procedures impacted by the CMS guidance to limit elective procedures. In addition,
the Company and our business partners need access to healthcare providers and facilities to conduct clinical trials and other
activities required to achieve regulatory clearance of products under development.
The
Company believes reductions in elective procedures in response to CMS guidance have had, and may in the future have, an adverse
impact, which may be material, to the Company’s financial condition, liquidity and results of operations. The severity of
the impact of the COVID-19 pandemic on the Company’s business will depend on a number of factors, including, but not limited
to, the duration and severity of the pandemic and the extent and severity of the impact on its customers, all of which are uncertain
and cannot be predicted. As of the date of filing of this Quarterly Report, the extent to which the COVID-19 pandemic may materially
impact the Company’s financial condition, liquidity or results of operations is uncertain. For further information, refer
to “Risk Factors” in Part II, Item 1A of this Quarterly Report and information in the Company’s other filings
with the Securities and Exchange Commission.
During
certain periods, including those impacted by the COVID-19 pandemic, the Company has incurred operating losses and negative cash
flows from operations. The Company incurred operating losses of $ 2,241 and $ 5,721 for the nine months ended September 30, 2020
and 2019, respectively, and had an accumulated deficit of $ 78,549 and $ 74,043 as of September 30, 2020 and December 31, 2019,
respectively. In addition, the Company used cash in operating activities of $ 534 and $ 702 for the nine months ended September
30, 2020 and 2019, respectively.
While
there is no assurance, management of the Company believes existing cash resources and restricted cash of $ 5,727 at September 30,
2020 together with cash generated from revenues, will be sufficient to sustain the Company’s planned level of operations
for at least the next twelve months. However, estimates of operating expenses, working capital requirements and the future impact
of the COVID-19 pandemic on its business could be incorrect, and the Company could use its cash resources faster than anticipated.
Further, some or all of the ongoing or planned activities may not be successful and could result in further losses.
The
Company may seek to increase liquidity and capital resources through a variety of means which may include, but are not limited
to: the sale of assets, investments and/or businesses; obtaining financing through the issuance of equity, debt, or convertible
securities; and working to increase revenue growth through sales. There is no guarantee that the Company will be able to obtain
capital when needed on terms management deems acceptable, or at all.
NOTE
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The
following represents an update for the three and nine months ended September 30, 2020 to the significant accounting policies described
in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019.
Segments
The
Company’s chief operating decision-maker is its Chief Executive Officer who makes resource allocation decisions and assesses
performance based on financial information presented as operating segments. The Company has identified two operating segments
as reportable segments. See Note 15 for more information regarding the Company’s reportable segments.
Noncontrolling
Interests
The
Company recognizes any noncontrolling interest as a separate line item in equity in the condensed consolidated financial statements.
A noncontrolling interest represents the portion of equity ownership in a less-than-wholly owned subsidiary not attributable to
the Company. Generally, any interest that holds less than 50% of the outstanding voting shares is deemed to be a noncontrolling
interest; however, there are other factors, such as decision-making rights, that are considered as well. The Company includes
the amount of net income (loss) attributable to noncontrolling interests in consolidated net income (loss) on the face of the
condensed consolidated statements of operations.
8
The
Company provides in the condensed consolidated statements of stockholders’ equity a reconciliation at the beginning and
the end of the period of the carrying amount of total equity, equity attributable to the parent, and equity attributable to the
noncontrolling interests that separately discloses:
(1)
net
income or loss;
(2)
transactions
with owners acting in their capacity as owners, showing separately contributions from and distributions to owners; and
(3)
each
component of other income or loss.
Basic
and Diluted Net Income (Loss) per Common Share
Basic
net income (loss) per common share is computed by dividing income (loss) attributable to common stockholders for the period by
the weighted average number of common shares outstanding during the period. Diluted income (loss) per share is computed by dividing
the income (loss) attributable to common stockholders for the period by the weighted average number of common and common equivalent
shares, such as stock options, restricted stock units (“RSUs”) and warrants, outstanding during the period.
Basic
and diluted net income (loss) per share is computed using the weighted average number of shares of common stock outstanding during
the period. Common stock equivalents (using the treasury stock or “if converted” method) from stock options, unvested
RSUs and warrants were 5,447,716 and 5,263,131 at September 30, 2020 and 2019, respectively, and, except for the three months
ended September 30, 2020, are excluded from the calculation of diluted net income (loss) per share for the periods presented,
because the effect is anti-dilutive. Included in the basic and diluted net income (loss) per share calculation were RSUs awarded
to directors that had vested, but the issuance and delivery of the shares are deferred until the director resigns. The number
of shares underlying vested RSUs at September 30, 2020 and 2019 was 281,507 and 314,588 , respectively.
The
following table shows the computation of basic net income (loss) per share of common stock for the three and nine months ended
September 30, 2020 and 2019:
SCHEDULE OF BASIC EARNINGS PER COMMON SHARE
2020
2019
2020
2019
For the Three Months Ended
For the Nine Months Ended
September
30,
September
30,
2020
2019
2020
2019
Numerator
– net income (loss) attributable to Harrow Health, Inc.
$ 8,638
$ ( 11,469 )
$ ( 4,506 )
$ ( 2,489 )
Denominator – weighted average
number of shares outstanding, basic
25,921,573
25,583,998
25,880,554
25,205,215
Net income (loss)
per share, basic
$ 0.33
$ ( 0.45 )
$ ( 0.17 )
$ ( 0.10 )
For
the three months ended September 30, 2020, the Company had net income. As a result, the Company computed diluted net income per
share using the weighted-average number of common shares and dilutive common equivalent shares outstanding during the period.
Diluted common equivalent shares for the three months ended September 30, 2020, consisted of the following:
SCHEDULE OF DILUTED COMMON EQUIVALENT SHARES
For
the Three months Ended
September
30, 2020
Diluted shares related to:
Warrants
504,742
Stock
options
663,745
Dilutive common
equivalent shares
1,168,487
9
The
following table shows the computation of diluted net income (loss) per share of common stock for the three and nine months ended
September 30, 2020 and 2019:
SCHEDULE OF DILUTED EARNINGS PER COMMON SHARE
2020
2019
2020
2019
For the Three Months Ended
For the Nine months Ended
September
30,
September
30,
2020
2019
2020
2019
Numerator
– net income (loss) attributable to Harrow Health, Inc.
$ 8,638
$ ( 11,469 )
$ ( 4,506 )
$ ( 2,489 )
Denominator – weighted average number of shares outstanding,
basic
25,921,573
25,583,998
25,880,554
25,205,215
Dilutive common
equivalent shares
1,168,487
-
-
-
Number of shares
used for diluted earnings per share computation
27,090,060
25,583,998
25,880,554
25,205,215
Net income (loss)
per share, diluted
$ 0.32
$ ( 0.45 )
$ ( 0.17 )
$ ( 0.10 )
Investment
in Eton Pharmaceuticals, Inc. – Related Party
The
Company owns 3,500,000 shares of Eton common stock, which represents approximately 16.7 % of the equity and voting interests of
Eton as of September 30, 2020. At September 30, 2020 the fair market value of Eton’s common stock was $ 7.90 per share. In
accordance with Accounting Standard’s Update (“ASU”) 2016-01, Financial Instruments-Overall (Subtopic 825-10):
Recognition and Measurement of Financial Assets and Financial Liabilities , for the three and nine months ended September 30,
2020, the Company recorded an investment gain (loss) from its Eton common stock position of $ 8,575 and $ 2,450 , respectively, related
to the change in fair market value of the Company’s investment in Eton during the measurement periods. As of September 30,
2020, the fair market value of the Company’s investment in Eton was $ 27,650 .
Mark
Baum, the Company’s Chief Executive Officer, is a member of the board of directors of Eton.
Investment
in Melt Pharmaceuticals, Inc. – Related Party
In
April 2018, the Company formed Melt as a wholly owned subsidiary. In January and March of 2019, Melt entered into definitive stock
purchase agreements (collectively, the “Melt Series A Preferred Stock Agreement”) with certain investors and closed
on the sale of Melt’s Series A Preferred Stock (the “Melt Series A Stock”), totaling approximately $ 11,400 of
proceeds (collectively, the “Melt Series A Round”) at a purchase price of $ 5.00 per share. As a result, the Company
lost voting and ownership control of Melt and ceased consolidating Melt’s financial statements.
In
January 2019, the Company deconsolidated Melt and recorded a gain of $ 5,810 and adjusted the carrying value in Melt to reflect
the increased valuation of Melt and the Company’s new ownership interest in accordance with Accounting Standard Codification
(“ASC”) 810-10-40-4(c), Consolidation .
The
Company owns 3,500,000 common shares of Melt (which is approximately 44 % of the equity interests as of September 30, 2020) and
uses the equity method of accounting for this investment, as management has determined that the Company has the ability to exercise
significant influence over the operating and financial decisions of Melt. Under this method, the Company recognizes earnings and
losses in Melt in its condensed consolidated financial statements and adjusts the carrying amount of its investment in Melt accordingly.
The Company’s share of earnings and losses are based on the Company’s ownership interest of Melt. Any intra-entity
profits and losses are eliminated. The Company recorded equity in the net loss of Melt of $ 300 and $ 1,536 during the three and
nine months ended September 30, 2020, respectively. The Company recorded equity in the net loss of Melt of $ 682 and $ 1,293 during
the three and nine months ended September 30, 2019, respectively. As of September 30, 2020, the carrying value of the Company’s
investment in Melt was $ 2,432 .
10
See
Note 4 for more information and related party disclosure regarding Melt.
Investment
in Surface Ophthalmics, Inc. – Related Party
The
Company owns 3,500,000 common shares (which is approximately 30 % of the equity interests as of September 30, 2020) of Surface
and uses the equity method of accounting for this investment, as management has determined that the Company has the ability to
exercise significant influence over the operating and financial decisions of Surface. Under this method, the Company recognizes
earnings and losses in Surface in its condensed consolidated financial statements and adjusts the carrying amount of its investment
in Surface accordingly. The Company’s share of earnings and losses are based on the Company’s ownership interest of
Surface. Any intra-entity profits and losses are eliminated. The Company recorded equity in the net loss of Surface of $ 756 and
$ 1,694 during the three and nine months ended September 30, 2020, respectively. The Company recorded equity in the net loss of
Surface of $ 400 and $ 904 during the three and nine months ended September 30, 2019, respectively. As of September 30, 2020, the
carrying value of the Company’s investment in Surface was $ 2,053 .
See
Note 5 for more information and related party disclosure regarding Surface.
Recently
Adopted Accounting Pronouncements
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments ,
which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13
replaces the existing incurred loss impairment model with a forward-looking expected credit loss model which will result in earlier
recognition of credit losses. The Company adopted ASU 2016-13 on January 1, 2020, and adoption of the standard did not have a
material effect on the Company’s consolidated financial position, results of operations and cash flows.
In
August 2018, the FASB issued ASU 2018-13, Changes to Disclosure Requirements for Fair Value Measurements , which improved
the effectiveness of disclosure requirements for recurring and nonrecurring fair value measurements. The standard removes, modifies,
and adds certain disclosure requirements. The Company adopted ASU 2018-13 on January 1, 2020, and adoption of the standard did
not have a material effect on the Company’s consolidated financial position, results of operations and cash flows.
In
January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other . This guidance simplifies the accounting for
goodwill impairment for all entities by requiring impairment charges to be based on the first step in the current two-step impairment
test under ASC 350. The updated standard eliminates the requirement to calculate a goodwill impairment charge using Step 2. If
a reporting unit’s carrying amount exceeds its fair value, an entity will record an impairment charge based on that difference.
The impairment charge will be limited to the amount of goodwill allocated to that reporting unit. The Company adopted ASU 2017-04
on January 1, 2020, and adoption of the standard did not have a material effect on the Company’s consolidated financial
position, results of operations and cash flows.
Recently
Issued Accounting Pronouncements
In
December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes , as part of its initiative to reduce
complexity in accounting standards. The amendments in the ASU are effective for fiscal years beginning after December 15, 2020,
including interim periods therein. Early adoption of the standard is permitted. The Company is currently assessing the impact
of this standard and does not expect ASU 2019-12 to have a material impact on its consolidated financial position, results of
operations and cash flows.
NOTE
3. REVENUES
The
Company accounts for contracts with customers in accordance with ASC 606, Revenues from Contracts with Customers . The Company
has two primary streams of revenues: (1) revenues recognized from our sale of products within our pharmacy services and (2) revenues
recognized from intellectual property license and asset purchase agreements.
11
Product
Revenues from Pharmacy Services
The
Company sells prescription drugs directly through our pharmacy and outsourcing facility network. Revenues from our pharmacy services
division includes: (i) the portion of the price the client pays directly to us, net of any volume-related or other discounts paid
back to the client, (ii) the price paid to us by individuals, and (iii) customer copayments made directly to the pharmacy network.
Sales taxes are not included in revenue. Following the core principle of ASC 606, we have identified the following:
1.
Identify
the contract(s) with a customer: A contract exists with a customer at the time the prescription or order is received by the
Company.
2.
Identify
the performance obligations in the contract: The order received contains the performance obligations to be met, in almost
all cases the product the customer is wishing to receive. If we are unable to be meet the performance obligation, the customer
is notified.
3.
Determine
the transaction price: the transaction price is based on the product being sold to the customer, and any related customer
discounts. These amounts are pre-determined and built into our order management software.
4.
Allocate
the transaction price to the performance obligations in the contract: The transaction price associated with the product(s)
being ordered is allocated according to the pre-determined amounts.
5.
Recognize
revenue when (or as) the entity satisfies a performance obligation: At the time of shipment from the pharmacy or outsourcing
facility, the performance obligation has been met.
The
following revenue recognition policy has been established for the pharmacy services division:
Revenues
generated from prescription or office use drugs sold by our pharmacies and outsourcing facility are recognized when the prescription
is shipped. At the time of shipment, the pharmacy services division has performed substantially all of its obligations under its
client contracts and does not experience a significant level of returns or reshipments. Determination of criteria (3) and (4)
is based on management’s judgments regarding the fixed nature of the selling prices of the products delivered and the collectability
of those amounts. The Company records reductions to revenue for discounts at the time of the initial sale. Estimated returns and
allowances and other adjustments are provided for in the same period during which the related sales are recorded and are based
on actual returns history. The rate of returns is analyzed annually to determine historical returns experience. If the historical
data we use to calculate these estimates do not properly reflect future returns, then a change in the allowance would be made
in the period in which such a determination is made and revenues in that period could be materially affected. The Company will
defer any revenues received for a product that has not been delivered or is subject to refund until such time that the Company
and the customer jointly determine that the product has been delivered and no refund will be required.
Commission
Revenues
During
the third quarter of 2020, the Company entered into an agreement whereby it
is paid a fee calculated based on sales it generates from a pharmaceutical product that is owned by a third party. The revenue
earned from this arrangement is recognized at the time a customer has ordered the pharmaceutical product and it has shipped from
the third party (or one of its distributors or affiliates), at which point there is no future performance obligation required
by the Company and no consequential continuing involvement on the part of the Company to recognize the associated revenue.
Intellectual
Property License Revenues
The
Company currently holds five intellectual property license and related agreements in which the Company has sold or granted a license
which provides a customer with the right to access the Company’s intellectual property. License arrangements may include
or require non-refundable upfront license fees, data transfer fees, research reimbursement payments, exclusive license rights
to patented or patent pending compounds, technology access fees, and various performance or sales milestones. These arrangements
can be multiple-element arrangements, the revenue of which is recognized at the point of time the performance obligation is met.
12
Non-refundable
fees that are not contingent on any future performance by the Company and require no consequential continuing involvement on the
part of the Company are recognized as revenue when the license term commences and the licensed data, technology, compounded drug
preparation and/or other deliverable is delivered. Such deliverables may include physical quantities of compounded drug preparations,
design of the compounded drug preparations and structure-activity relationships, the conceptual framework and mechanism of action,
and rights to the patents or patent applications for such compounded drug preparations. The Company defers recognition of non-refundable
fees if it has continuing performance obligations without which the technology, right, product or service conveyed in conjunction
with the non-refundable fee has no utility to the licensee and that are separate and independent of the Company’s performance
under the other elements of the arrangement. In addition, if the Company’s continued involvement is required, through research
and development services that are related to its proprietary know-how and expertise of the delivered technology or can only be
performed by the Company, then such non-refundable fees are deferred and recognized over the period of continuing involvement.
Guaranteed minimum annual royalties are recognized on a straight-line basis over the applicable term.
Revenue
disaggregated by revenue source for the three and nine months ended September 30, 2020 and 2019, consists of the following:
SCHEDULE OF DISAGGREGATED REVENUE
For the Three Months Ended
For the Nine months Ended
September
30,
September
30,
2020
2019
2020
2019
Product sales, net
$ 14,385
$ 12,748
$ 34,244
$ 38,540
Commissions
7
-
7
-
License
7
7
25
21
Total
revenue s
$ 14,399
$ 12,755
$ 34,276
$ 38,561
Deferred
revenue and customer deposits at September 30, 2020 and December 31, 2019, was $ 63 and $ 57 , respectively. All deferred revenue
and customer deposit amounts at December 31, 2019 were recognized as revenue during the nine months ended September 30, 2020.
NOTE
4. INVESTMENT IN MELT PHARMACEUTICALS, INC. AND AGREEMENTS - RELATED PARTY TRANSACTIONS
In
December 2018, the Company entered into an asset purchase agreement with Melt (the “Melt Asset Purchase Agreement”).
Pursuant to the terms of the Melt Asset Purchase Agreement, Melt was assigned certain intellectual property and related rights
from the Company to develop, formulate, make, sell, and sub-license certain Company conscious sedation and analgesia related formulations
(collectively, the “Melt Products”). Under the terms of the Melt Asset Purchase Agreement, Melt is required to make
royalty payments to the Company up to 5 % of net sales of the Melt Products while any patent rights remain outstanding, as well
as other conditions. In January and March 2019, the Company entered into the Melt Series A Preferred Stock Agreement.
In
February 2019, the Company and Melt entered into a Management Services Agreement (the “Melt MSA”), whereby the Company
provides to Melt certain administrative services and support, including bookkeeping, web services and human resources related
activities, and Melt pays the Company a monthly amount of $ 10 .
As
of September 30, 2020, the Company was due $ 815 from Melt for reimbursable expenses and amounts due under the Melt MSA and are
included in prepaid expenses and other current assets on the accompanying condensed consolidated balance sheets. During the three
and nine months ended September 30, 2020, Melt did not make any payments to the Company.
13
The
Company’s Chief Executive Officer, Mark L. Baum, and Chief Medical Officer, Larry Dillaha, are members of the Melt board
of directors.
The
unaudited condensed results of operations information of Melt is summarized below:
SCHEDULE OF CONDENSED INCOME STATEMENT
For the
Nine Months Ended
September
30, 2020
Revenues, net
$ -
Loss
from operations
3,261
Net loss
$ ( 3,261 )
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE OF CONDENSED BALANCE SHEET
September
30,
2020
Current assets
$ 4,072
Non current assets
12
Total assets
$ 4,084
Total liabilities
$ 1,452
Total preferred
stock and stockholders’ equity
2,632
Total liabilities
and stockholders’ equity
$ 4,084
NOTE
5. INVESTMENT IN SURFACE OPHTHALMICS, INC. AND AGREEMENTS - RELATED PARTY TRANSACTIONS
The
Company entered into an asset purchase and license agreement with Surface in 2017, and amended it in April 2018 (the “Surface
License Agreements”). Pursuant to the terms of the Surface License Agreements, the Company assigned and licensed to Surface
certain intellectual property and related rights to develop, formulate, make, sell, and sub-license ophthalmic formulations (collectively,
the “Surface Products”). Surface is required to make royalty payments to the Company of 4 % - 6 % of net sales of the
Surface Products while any patent rights remain outstanding.
A
Company director, Richard L. Lindstrom, and the Company’s Chief Executive Officer, Mark L. Baum, are directors of Surface.
Surface is required to make royalty payments to Dr. Lindstrom of 3 % of net sales of certain Surface Products while certain patent
rights remain outstanding. Dr. Lindstrom is also a principal of Flying L Partners, an affiliate of the funding investor who purchased
the Surface Series A Preferred Stock.
The
unaudited condensed results of operations information of Surface is summarized below:
SUMMARY OF CONDENSED INCOME STATEMENT
For the
Nine Months Ended
September
30, 2020
Revenues, net
$ -
Loss
from operations
5,647
Net loss
$ ( 5,647 )
The
unaudited condensed balance sheet information of Surface is summarized below:
SUMMARY OF CONDENSED BALANCE SHEET
September 30,
2020
Current assets
$ 11,547
Non current assets
45
Total assets
$ 11,592
Total liabilities
$ 1,754
Total stockholders’
equity
9,838
Total liabilities
and stockholders’ equity
$ 11,592
14
NOTE
6. INVENTORIES
Inventories
are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, commercial pharmaceutical
products, related laboratory supplies and active pharmaceutical ingredients. The composition of inventories as of September 30,
2020 and December 31, 2019 was as follows:
SCHEDULE OF INVENTORIES
2020
2019
September 30,
December 31,
2020
2019
Raw materials
$ 2,838
$ 2,405
Work in progress
4
20
Finished goods
1,132
876
Total inventories
$ 3,974
$ 3,301
NOTE
7. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets consisted of the following:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
September 30,
December 31,
2020
2019
Prepaid insurance
$ 149
$ 123
Other prepaid expenses
378
358
Receivable due from Melt
815
722
Deposits and
other current assets
89
105
Total prepaid
expenses and other current assets
$ 1,431
$ 1,308
NOTE
8. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment, net consisted of the following:
SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT
2020
2019
September 30,
December 31,
2020
2019
Property, plant and
equipment, net:
Computer
software and hardware
$ 1,902
$ 1,732
Furniture
and equipment
463
363
Lab
and pharmacy equipment
3,464
3,164
Leasehold
improvements
5,720
5,510
Property, plant and equipment, gross
11,549
10,769
Accumulated
depreciation and amortization
( 6,776 )
( 5,394 )
Property,
plant and equipment, net
$ 4,773
$ 5,375
For
the three and nine months ended September 30, 2020, depreciation and amortization related to the property, plant and equipment
was $ 464 and $ 1,377 , respectively. For the three and nine months ended September 30, 2019, depreciation related to the property,
plant and equipment was $ 397 and $ 1,365 , respectively. During the three and nine months ended September 30, 2019, the Company
impaired $ 445 of property, plant and equipment related to the Park Restructuring.
15
NOTE
9. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at September 30, 2020 consisted of the following:
SCHEDULE OF INTANGIBLE ASSETS
Amortization
periods
Accumulated
Net
(in
years)
Cost
amortization
Impairment
Carrying
value
Patents
17 - 19 years
$ 911
$ ( 86 )
$ ( 363 )
$ 462
Licenses
20 years
50
( 6 )
-
44
Trademarks
Indefinite
353
-
-
353
Customer relationships
3 - 15 years
1,519
( 421 )
-
1,098
Trade name
5 years
5
( 5 )
-
-
Non-competition clause
3 - 4 years
50
( 50 )
-
-
State pharmacy
licenses
25 years
8
( 7 )
-
1
$ 2,896
$ ( 575 )
$ ( 363 )
$ 1,958
During
the nine months ended September 30, 2020, the Company recorded impairment charges of $ 363 related to patent filings associated
with products that the Company was no longer actively selling.
Amortization
expense for intangible assets for the three and nine months ended September 30, 2020 and 2019 was as follows:
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
For the
For the
Three Months Ended
Nine Months Ended
September 30,
September 30,
2020
2019
2020
2019
Patents
$ 6
$ 22
$ 25
$ 37
Licenses
-
-
1
5
Customer relationships
33
26
101
128
Trade name
-
1
-
1
State pharmacy
licenses
-
3
-
4
$ 39
$ 52
$ 127
$ 175
Estimated
future amortization expense for the Company’s intangible assets at September 30, 2020 is as follows:
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE
2020
Remainder
of 2020
$ 47
2021
173
2022
173
2023
173
2024
146
Thereafter
893
Intangible assets
$ 1,605
There
have been no changes in the carrying value of the Company’s goodwill during the three and nine months ended September 30,
2020.
16
NOTE
10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses consisted of the following:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
2020
2019
September 30,
December 31,
2020
2019
Accounts payable
$ 5,511
$ 7,409
Other accrued expenses
-
49
Accrued interest
180
244
Accrued exit
fee for note payable
800
800
Total accounts payable and accrued expenses
6,491
8,502
Less: Current
portion
( 5,691 )
( 7,702 )
Non-current total
accrued expenses
$ 800
$ 800
NOTE
11. DEBT
In
July 2017, the Company entered into a term loan and security agreement in the principal amount of $ 16,000 (the “SWK Loan
Agreement” or “SWK Loan”) with SWK Funding LLC and its partners (collectively, “SWK”), as lender
and collateral agent. The SWK Loan Agreement was fully funded at closing with a five-year term; however, such term could be reduced
to four years if certain revenue requirements are not achieved. The SWK Loan is secured by substantially all of the Company’s
assets, including its intellectual property rights. The SWK Loan was subsequently amended in May 2019 and again in April 2020
(see below). The SWK Loan bears an interest rate that is equal to the three-month London Inter-Bank Offered Rate (subject to a
minimum of 2.00 % ), plus an applicable margin of 10.00 % (the “Margin Rate”); provided that, if, two days prior to a
payment date, the Company provides SWK evidence that the Company has achieved a leverage ratio as of such date of less than 4.00:1:00,
the Margin Rate shall equal 9.00%; and if the Company has achieved a leverage ratio as of such date of less than 3.00:1:00, the
Margin Rate shall equal 7.00%. The leverage ratio means, as of any date of determination, the ratio of: (a) indebtedness as of
such date to (b) EBITDA (as defined in the SWK Loan), of the Company for the immediately preceding 12 month period, adding-back
(i) actual litigation expenses for the immediately preceding 12 month period, minus (ii) actual litigation expenses for the immediately
preceding 3 month period multiplied by 4.
Second
Amendment to SWK Loan
On
April 1, 2020, the Company and several of its wholly owned subsidiaries entered into a second amendment (the “SWK Amendment”)
to the SWK Loan, with SWK. A summary of the material changes contained in the SWK Amendment are as follows:
●
SWK
agreed to make available to the Company, and the Company drew down on, an additional principal amount of $ 1,000 ;
●
The
definition of the first amortization date was changed to August 14, 2020, permitting the Company to pay interest only on the
principal amount loaned for the next payment (payments are due on a quarterly basis) following the SWK Amendment; and
●
The
interest payment due May 14, 2020 will be paid in kind by increasing the principal amount of the term loans by an amount equal
to the interest accrued as of such date.
Paycheck
Protection Program Loan
In
April 2020, the Company entered into an unsecured promissory note and related Business Loan Agreement with Renasant Bank, as lender,
for a loan (the “PPP Loan”) in the principal amount of $ 1,967 and received cash proceeds of the same amount, pursuant
to the Paycheck Protection Program (the “PPP”) under the Federal Coronavirus Aid, Relief, and Economic Security Act
(the “CARES Act”), which was enacted March 27, 2020. The PPP is administered by the U.S. Small Business Administration.
17
Under
the terms of the PPP Loan, interest accrues on the outstanding principal at the rate of 1.0 % per annum. The term of the PPP Loan
is two years, unless sooner required in connection with an event of default under the PPP Loan. To the extent the PPP Loan amount
is not forgiven under the PPP, the Company is obligated to make equal monthly payments of principal and interest, beginning seven
months from the date of the PPP Loan, until the maturity date.
The
CARES Act and the PPP provide a mechanism for forgiveness of up to the full amount borrowed. Under the PPP, the Company may apply
for and be granted forgiveness for all or part of the PPP Loan. The amount of loan proceeds eligible for forgiveness is based
on a formula that takes into account a number of factors, including the amount of loan proceeds used by the Company during the
eight-week period after the loan origination for certain purposes including payroll costs, interest on certain mortgage obligations,
rent payments on certain leases, and certain qualified utility payments ( it being anticipated that at least 75% of the loan amount
will be required to be used for eligible payroll costs ); the employer maintaining or rehiring employees and maintaining salaries
at certain levels; and other factors. Subject to the other requirements and limitations on loan forgiveness, only loan proceeds
spent on payroll and other eligible expenses during the covered eight-week period will qualify for forgiveness. While the Company
has used proceeds from the PPP Loan for such qualifying expenses, in particular maintaining continuity of its payroll and workforce
(including staff critical to the timely production and dispensing of medicines the Company produces), no assurance can be provided
that the Company will apply for and subsequently obtain forgiveness of the PPP Loan in whole or in part.
At
September 30, 2020, future minimum payments under the Company’s debt agreements were as follows:
SUMMARY OF FUTURE MINIMUM PAYMENTS
2020
Amount
Remainder of 2020
$ 1,299
2021
5,430
2022
4,437
2023
9,669
Total minimum payments
20,835
Less: amount
representing estimated interest
( 3,020 )
Loans payable, gross
17,815
Less: unamortized
discount
( 905 )
Notes payable
16,910
Less: current
portion, net of unamortized discount
( 3,750 )
Loans payable,
net of current portion and unamortized debt discount
$ 13,160
For
the three and nine months ended September 30, 2020, debt discount amortization related to the SWK loan payable was $ 111 and $ 354 ,
respectively. For the three and nine months ended September 30, 2019, debt discount amortization related to the SWK loan payable
was $ 127 and $ 377 , respectively.
NOTE
12. LEASES
The
Company’s leases of office and laboratory space under the non-cancelable operating leases listed below. These lease agreements
have remaining lease terms between one to four years and contain various clauses for renewal at our option.
●
An
operating lease for 10,200 square feet of office space in San Diego, California that expires in December 2021 , with an option
to extend the term for a five-year period ;
●
An
operating lease for 26,400
square feet of lab, warehouse and
office space in Ledgewood, New Jersey, that expires in July
2026 , with an option to extend the
term
for two additional five-year periods .
This includes an amendment that was made effective July 2020 that extended the term of the original lease and added 1,400
of additional square footage to
the lease; and
●
An
operating lease for 5,500 square feet of office space in Nashville, Tennessee, that expires in December 2024 , with an option
to extend the term for two additional five-year periods .
18
During
the three months ended September 30, 2020, the Company terminated its operating lease for 4,500 square feet of office and lab
space in Irvine, California that had an expiration date in December 2020 . In connection with the termination, the Company recorded
a gain of $ 4 which was recognized in other income (expense) on the condensed consolidated financial statements.
At
September 30, 2020, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating
leases held by the Company were 6.33 % and 11.38 years , respectively.
During
the three and nine months ended September 30, 2020, cash paid for amounts included for the operating lease liabilities was $ 258
and $ 805 , respectively, and the Company recorded operating lease expense of $ 261 and $ 816 , respectively, included in selling,
general and administrative expenses.
Future
lease payments under operating leases as of September 30, 2020 were as follows :
SCHEDULE OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES
2020
Operating
Leases
Remainder of 2020
$ 250
2021
1,017
2022
1,038
2023
1,064
2024
1,090
Thereafter
6,056
Total minimum lease payments
10,515
Less: amount
representing interest payments
( 3,156 )
Total operating lease liabilities
7,359
Less: current
portion, operating lease liabilities
( 579 )
Operating lease
liabilities, net of current portion
$ 6,780
The
Company also has a finance lease that is included in its lease accounting but is not considered significant.
Future
lease payments under finance leases as of September 30, 2020 were as follows :
SCHEDULE OF FUTURE LEASE PAYMENT UNDER FINANCE LEASE
2020
Finance
Leases
Remainder of 2020
$ 2
2021
9
2022
9
2023
9
2024
1
Total minimum lease payments
30
Less: amount
representing interest payments
( 3 )
Present value of future minimum lease
payments
27
Less: current
portion, finance lease obligation
( 7 )
Finance lease
obligation, net of current portion
$ 20
19
At
September 30, 2020, the incremental borrowing rate and the remaining lease term for the finance lease held by the Company were
6.36 % and 3.33 years , respectively.
For
the three and nine months ended September 30, 2020, depreciation expense related to the equipment held under the finance lease
obligation was $ 2 and $ 6 , respectively.
For
the three and nine months ended September 30, 2020, cash paid and expense recognized for interest expense related to the
finance lease obligation was $ 0
and $ 1 ,
respectively.
NOTE
13. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Common
Stock
In
May 2020, the Company issued 30,000 shares of its restricted common stock, with a fair value of $ 167 , as consideration for commission
expenses incurred during the year ended December 31, 2019 and the nine months ended September 30, 2020.
During
the nine months ended September 30, 2020, the Company issued 253 shares of its common stock upon the cashless exercise of 750
options to purchase common stock, with an exercise price of $ 3.04 per share, net of 69 shares of common stock withheld for payroll
tax withholdings.
During
the nine months ended September 30, 2020, the Company issued 2,998 shares of its common stock upon the exercise of 2,998 options
to purchase common stock, with exercise prices ranging from $ 3.04 to $ 3.20 per share, and paid $ 8 related to payroll tax withholdings.
During
the nine months ended September 30, 2020, the Company issued 91,987 shares of its common stock underlying RSUs held by a director
that resigned. The RSUs had previously vested, including 2,429 RSUs during the nine months ended September 30, 2020, but the issuance
and delivery of the shares were deferred until the director resigned.
During
the nine months ended September 30, 2020, 46,762 shares of the Company’s common stock underlying RSUs issued to directors
vested, but the issuance and delivery of these shares are deferred until the resignation of a director.
Stock
Option Plan
On
September 17, 2007, the Company’s Board of Directors and stockholders adopted the Company’s 2007 Incentive Stock and
Awards Plan, which was subsequently amended on November 5, 2008, February 26, 2012, July 18, 2012, May 2, 2013 and September 27,
2013 (as amended, the “2007 Plan”). The 2007 Plan reached its term in September 2017, and we can no longer issue additional
awards under this plan, however, options previously issued under the 2007 Plan will remain outstanding until they are exercised,
reach their maturity or are otherwise cancelled/forfeited. On June 13, 2017, the Company’s Board of Directors and stockholders
adopted the Company’s 2017 Incentive Stock and Awards Plan (the “2017 Plan” together with the 2007 Plan, the
“Plans”). As of September 30, 2020, the 2017 Plan provides for the issuance of a maximum of 2,000,000 shares of the
Company’s common stock. The purpose of the Plans are to attract and retain directors, officers, consultants, advisors and
employees whose services are considered valuable, to encourage a sense of proprietorship and to stimulate an active interest of
such persons in the Company’s development and financial success. Under the Plans, the Company is authorized to issue incentive
stock options intended to qualify under Section 422 of the Internal Revenue Code, non-qualified stock options, restricted stock
units and restricted stock. The Plans are administered by the Compensation Committee of the Company’s Board of Directors.
The Company had 342,882 shares available for future issuances under the 2017 Plan at September 30, 2020.
20
Stock
Options
A
summary of stock option activity under the Plans for the nine months ended September 30, 2020 is as follows:
SCHEDULE OF STOCK OPTION PLAN ACTIVITY
Number
of shares
Weighted
Avg. Exercise Price
Weighted
Avg. Remaining Contractual Life
Aggregate
Intrinsic Value
Options outstanding - January 1, 2020
2,656,683
$ 5.30
Options granted
414,500
$ 6.44
Options exercised
( 3,748 )
$ 3.06
Options cancelled/forfeited
( 14,369 )
$ 17.42
Options outstanding - September
30, 2020
3,053,066
$ 5.41
5.97
$ 3,608
Options exercisable – September
30, 2020
1,855,150
$ 4.45
5.38
$ 3,294
Options vested
and expected to vest – September 30, 2020
2,940,527
$ 5.34
5.93
$ 3,605
The
aggregate intrinsic value in the table above represents the total pre-tax amount of the proceeds, net of exercise price, which
would have been received by option holders if all option holders had exercised and immediately sold all options with an exercise
price lower than the market price on September 30, 2020, based on the closing price of the Company’s common stock of $ 5.59
on that date.
During
the nine months ended September 30, 2020, the Company granted stock options to certain employees and a consultant. The stock options
were granted with an exercise price equal to the current market price of the Company’s common stock, as reported by the
securities exchange on which the common stock was then listed, at the grant date and have contractual terms of 10 years. Vesting
terms for options granted to employees and consultants during the nine months ended September 30, 2020 generally included one
of the following vesting schedules: 25% of the shares subject to the option vest and become exercisable on the first anniversary
of the grant date and the remaining 75% of the shares subject to the option vest and become exercisable quarterly in equal installments
thereafter over three years; and 100% of the shares subject to the option vest on a quarterly basis in equal installments over
three years. Certain option awards provide for accelerated vesting if there is a change in control (as defined in the Plans) and
in the event of certain modifications to the option award agreement.
On
July 31, 2015, the Company granted to its Chief Executive Officer, Mark Baum, an option (the “Baum Performance Option”)
to purchase 600,000 shares of the Company’s common stock at an exercise price of $ 7.87 per share under the 2007 Plan subject
to the satisfaction of certain market-based vesting criteria. The market-based vesting criteria are separated into five tranches
and require that the Company achieve and maintain certain average stock price targets ranging from $ 9 per share to $ 15 per share
during the five year period following the grant date. On June 4, 2020, the Company amended the Baum Performance Option, to extend
the vesting and contractual term by 5 years. The Company treated this amendment as a modification to the Baum Performance Option
for accounting purposes. The fair value of the modification was $ 1,876 using a Monte Carlo Simulation with a five year life, 70 %
volatility and a risk-free interest rate of 0.40 % .
With
the exception of the Baum Performance Option, the fair value of each option award is estimated on the date of grant using the
Black-Scholes-Merton option pricing model. The expected term of options granted to employees and directors was determined in accordance
with the “simplified approach,” as the Company has limited, relevant, historical data on employee exercises and post-vesting
employment termination behavior. The expected risk-free interest rate is based on the U.S. Treasury yield for a period consistent
with the expected term of the option in effect at the time of the grant. The financial statement effect of forfeitures is estimated
at the time of grant and revised, if necessary, if the actual effect differs from those estimates. For option grants to employees
and directors, the Company assigns a forfeiture rate of 10 % . These factors could change in the future, which would affect the
determination of stock-based compensation expense in future periods. Utilizing these assumptions, the fair value is determined
at the date of grant.
21
The
table below illustrates the fair value per share determined by the Black-Scholes-Merton option pricing model with the following
assumptions used for valuing options granted to employees:
SCHEDULE OF FAIR VALUE ASSUMPTIONS
2020
Weighted-average fair value
of options granted
$ 3.86
Expected terms (in years)
0.5
– 6.11
Expected volatility
66.5 %
- 71.4 %
Risk-free interest rate
0.34 %
- 1.64 %
Dividend yield
-
The
following table summarizes information about stock options outstanding and exercisable at September 30, 2020:
SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE
Options
Outstanding
Options
Exercisable
Weighted
Average
Weighted
Weighted
Remaining
Average
Average
Number
Contractual
Exercise
Number
Exercise
Range
of Exercise Prices
Outstanding
Life
in Years
Price
Exercisable
Price
$ 1.47 -
$ 2.60
778,690
5.90
$ 2.05
728,938
$ 2.07
$ 2.76 - $ 4.66
531,785
5.95
$ 3.98
453,157
$ 3.98
$ 5.49 - $ 6.36
496,350
7.47
$ 6.10
263,814
$ 6.12
$ 6.64
- $ 8.99
1,246,241
5.42
$ 7.85
409,241
$ 8.13
$ 1.47
- $ 8.99
3,053,066
5.97
$ 5.41
1,855,150
$ 4.45
As
of September 30, 2020, there was approximately $ 6,021
of total unrecognized compensation
expense related to unvested stock options granted under the Plans. That expense is expected to be recognized over the weighted-average
remaining vesting period of 4.03
years. The stock-based compensation expense
for all stock options was $ 559
and $ 1,094
during the three and nine months ended
September 30, 2020, respectively.
Restricted
Stock Units
RSU
awards are granted subject to certain vesting requirements and other restrictions, including performance and market-based vesting
criteria. The grant date fair value of the RSUs, which has been determined based upon the market value of the Company’s
common stock on the grant date, is expensed over the vesting period of the RSUs.
During
the nine months ended September 30, 2020, the Company’s board of directors were granted 68,024
RSUs with a fair market value $ 400
which vest on a quarterly basis, over one year in equal installments.
During the nine months ended September 30, 2020, the Company granted 10,000 RSUs to a new member of its board of directors, with
a fair market value of $ 39 which vest on the one-year anniversary of the grant date.
During the three and nine months ended September 30, 2020, the Company granted 12,500 RSUs to a new member of its board of directors,
with a fair market value of $ 72 which vest on the one-year anniversary of the grant date.
During
the nine months ended September 30, 2020, 161,000 RSUs with a fair market value of $ 1,025 were issued to certain employees; the
RSUs vest in full on the third anniversary of the grant date.
22
A
summary of the Company’s RSU activity and related information for the nine months ended September 30, 2020 is as follows:
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY
Number
of RSUs
Weighted
Average Grant Date Fair Value
RSUs unvested - January 1, 2020
1,411,930
$ 2.76
RSUs granted
251,524
$ 6.11
RSUs vested
( 49,190 )
$ 6.61
RSUs cancelled/forfeited
-
RSUs unvested at September 30,
2020
1,614,264
$ 3.16
As
of September 30, 2020, the total unrecognized compensation expense related to unvested RSUs was approximately $ 1,610 , which is
expected to be recognized over a weighted-average period of 0.42 years, based on estimated and actual vesting schedules of the
applicable RSUs. The stock-based compensation for RSUs during the three and nine months ended September 30, 2020 was $ 357 and
$ 884 , respectively.
Warrants
From
time to time, the Company issues warrants to purchase shares of the Company’s common stock to investors, lenders, underwriters
and other non-employees for services rendered or to be rendered in the future, or pursuant to settlement agreements.
A
summary of warrant activity for the nine months ended September 30, 2020 is as follows:
SCHEDULE OF WARRANTS ACTIVITY
Number
of Shares Subject to Warrants Outstanding
Weighted
Avg. Exercise Price
Warrants outstanding - January 1, 2020
780,386
$ 2.12
Granted
-
Exercised
-
Expired
-
Warrants outstanding
and exercisable - September 30, 2020
780,386
$ 2.12
Weighted average
remaining contractual life of the outstanding warrants in years - September 30, 2020
3.78
Warrants
outstanding and exercisable as of September 30, 2020 are as follows:
SCHEDULE OF WARRANTS OUTSTANDING AND WARRANTS EXERCISABLE
Warrants
Exercise
Expiration
Warrant Series
Issue
Date
Outstanding
Price
Date
Lender warrants
5/11/2015
125,000
$ 1.79
5/11/2025
Settlement warrants
8/16/2016
40,000
$ 3.75
8/16/2021
Lender warrants
7/19/2017
615,386
$ 2.08
7/19/2024
780,386
$ 2.12
Subsidiary
Stock-Based Transactions
Mayfield
Pharmaceuticals, Inc.
During
the nine months ended September 30, 2020, Mayfield repurchased 650,000 shares of its common stock from Elle, for an aggregate
purchase price of $ 1 .
23
During
the nine months ended September 30, 2020, Mayfield issued 475,000 shares of its restricted common stock, with a fair value of
$ 11 , that vest upon various performance-based milestones and over a four-year service period to Mayfield’s Chief Executive
Officer candidate. During the nine months ended September 30, 2020, the Company recognized $ 17 in stock-based compensation tied
to the Mayfield stock options.
During
the nine months ended September 30, 2020, 500,000 shares of Mayfield’s restricted common stock were forfeited by a consultant.
Stock-Based
Compensation Summary
The
Company recorded stock-based compensation related to equity instruments granted to employees, directors and consultants as follows:
SCHEDULE OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES DIRECTORS CONSULTANTS
For the
For the
Three
Months Ended
Nine
Months Ended
September
30, 2020
September
30, 2019
September
30, 2020
September
30, 2019
Employees - selling, general
and administrative
$ 740
$ 252
$ 1,612
$ 1,158
Directors - selling, general and administrative
177
75
370
225
Consultants -
selling, general and administrative
-
76
96
175
Total
$ 917
$ 403
$ 2,078
$ 1,558
NOTE
14. COMMITMENTS AND CONTINGENCIES
Novel
Drug Solutions et al.
In
April 2018, Novel Drug Solutions, LLC and Eyecare Northwest, PA (collectively “NDS”) filed a lawsuit against the Company
in the U.S. District Court of Delaware asserting claims for breach of contract. The claims stem from an asset purchase agreement
between the Company and NDS entered into in 2013. In July 2019, NDS filed a second amended complaint which added a claim related
to its purported termination of the APA. In October 2019, NDS voluntarily dismissed all claims related to breach of contract,
leaving only claims related to the scope of the post-termination obligations to be litigated. On October 29, 2020, at a hearing
on the various dispositive motions before it, the Court found that there were triable issues of fact and reopened discovery for
limited purposes. NDS is seeking unspecified damages, interest, attorney’s fees and other costs. The Company believes
the claims are meritless and has previously and will continue to dispute all claims asserted against it and intends to vigorously
defend against these allegations. Nonetheless, the Company cannot predict the eventual outcome of this litigation and it could
result in substantial costs, losses and a diversion of management’s resources and attention, which could harm the Company’s
business and the value of its common stock.
Product
and Professional Liability
Product
and professional liability litigation represents an inherent risk to all firms in the pharmaceutical and pharmacy industry. We
utilize traditional third-party insurance policies with regard to our product and professional liability claims. Such insurance
coverage at any given time reflects current market conditions, including cost and availability, when the policy is written.
24
John
Erick et al.
In January 2018, John Erick and Deborah
Ferrell, successors-in-interest and heirs of Jade Erick, (collectively “Erick”) filed a lawsuit in the San Diego
County Superior against Kim Kelly, ND, MPH asserting claims related to the death of Jade Erick. In April 2018, Erick filed an
amendment to the lawsuit, naming the Company as a co-defendant. In September 2018, co-defendant Dr. Kelly filed a
cross-complaint against the Company and various entities affiliated with Spectrum Laboratory Products, Inc., Spectrum
Chemical Manufacturing Corp. and Spectrum Pharmacy Products, Inc. (collectively “Spectrum”). The cross-complaint
seeks indemnity and contribution from the Company and Spectrum. The Company answered the claims filed by Dr. Kelly in October
2018. The case is currently in the discovery phase and the Company’s motion for summary adjudication is pending
before the Court. Erick is seeking unspecified damages, interest, attorney’s fees and other costs. The Company
believes the claims are meritless and has previously and will continue to dispute all claims asserted against it and intends
to vigorously defend against these allegations. Nonetheless, the Company cannot predict the eventual outcome of this
litigation, it could result in substantial costs, losses and a diversion of management’s resources and attention, which
could harm the Company’s business and the value of its common stock.
General
and Other
In
the ordinary course of business, the Company may face various claims brought by third parties and it may, from time to time, make
claims or take legal actions to assert its rights, including intellectual property disputes, contractual disputes and other commercial
disputes. Any of these claims could subject the Company to litigation.
Indemnities
In
addition to the indemnification provisions contained in the Company’s governing documents, the Company generally enters
into separate indemnification agreements with each of the Company’s directors and officers. These agreements require the
Company, among other things, to indemnify the director or officer against specified expenses and liabilities, such as attorneys’
fees, judgments, fines and settlements, paid by the individual in connection with any action, suit or proceeding arising out of
the individual’s status or service as the Company’s director or officer, other than liabilities arising from willful
misconduct or conduct that is knowingly fraudulent or deliberately dishonest, and to advance expenses incurred by the individual
in connection with any proceeding against the individual with respect to which the individual may be entitled to indemnification
by the Company. The Company also indemnifies its lessors in connection with its facility leases for certain claims arising from
the use of the facilities. These indemnities do not provide for any limitation of the maximum potential future payments the Company
could be obligated to make. Historically, the Company has not incurred any payments for these obligations and, therefore, no liabilities
have been recorded for these indemnities in the accompanying condensed consolidated balance sheets.
Klarity
License Agreement – Related Party
The
Company entered into a license agreement in April 2017 and as amended in April 2018, (the “Klarity License Agreement”)
with Richard L. Lindstrom, M.D., a member of its Board of Directors. Pursuant to the terms of the Klarity License Agreement, the
Company licensed certain intellectual property and related rights from Dr. Lindstrom to develop, formulate, make, sell, and sub-license
the topical ophthalmic solution Klarity used to protect and rehabilitate the ocular surface (the “Klarity Product”).
Under
the terms of the Klarity License Agreement, the Company is required to make royalty payments to Dr. Lindstrom ranging from 3%
to 6% of net sales, dependent upon the final formulation of the Klarity Product sold. In addition, the Company is required to
make certain milestone payments to Dr. Lindstrom including: (i) an initial payment of $ 50 upon execution of the Klarity License
Agreement, (ii) a second payment of $ 50 following the first $ 50 in net sales of the Klarity Product; and (iii) a final payment
of $ 50 following the first $ 100 in net sales of the Klarity Product. All of the above referenced milestone payments are payable
at the Company’s election in cash or shares of the Company’s restricted common stock. Payments totaling $ 0 and $ 55
were made during the three and nine months ended September 30, 2020, respectively. Royalty expense of $ 38 and $ 94 was incurred
during the three and nine months ended September 30, 2020, respectively, is included in accounts payable and is due to Dr.
Lindstrom at September 30, 2020.
25
Injectable
Asset Purchase Agreement – Related Party
In
December 2019, the Company entered into an asset purchase agreement (the “Lindstrom APA”) with Dr. Lindstrom, a member
of its Board of Directors. Pursuant to the terms of the Lindstrom APA, the Company acquired certain intellectual property and
related rights from Dr. Lindstrom to develop, formulate, make, sell, and sub-license an ophthalmic injectable product (the “Lindstrom
Product”).
Under
the terms of the Lindstrom APA, the Company is required to make royalty payments to Dr. Lindstrom ranging from 2% to 3% of net
sales, dependent upon the final formulation and patent protection of the Lindstrom Product sold. In addition, the Company is required
to make certain milestone payments to Dr. Lindstrom including an initial payment of $ 33 upon execution of the Lindstrom APA. Dr.
Lindstrom was paid $ 0 and $ 7 in cash during the three and nine months ended September 30, 2020, respectively, and an additional
$ 48 was payable to Dr. Lindstrom at September 30, 2020. The Company incurred royalty expense of $ 6 and $ 48 related to the Lindstrom
APA during the three and nine months ended September 30, 2020, respectively.
Eyepoint
Commercial Alliance Agreement
In
August 2020, the Company, through its wholly-owned subsidiary ImprimisRx, LLC, entered into a Commercial Alliance Agreement (the
“Dexycu Agreement”) with Eyepoint Pharmaceuticals, Inc. (“Eyepoint”), pursuant to which Eyepoint granted
the Company the non-exclusive right to co-promote DEXYCU ® (dexamethasone intraocular suspension) 9% for the treatment
of post-operative inflammation following ocular surgery in the United States. Pursuant
to the Dexycu Agreement , Eyepoint will pay the Company a fee calculated based on
the quarterly sales of DEXCYU in excess of predefined volumes to specific customers of the Company in the U.S. Under the terms
of the Dexycu Agreement , the Company shall use commercially reasonable efforts to
promote and market DEXCYU in the U.S.
Subject
to early termination, the Dexycu Agreement expires on August 1, 2025 , subject to
specified notice periods and specified limitations, either party may terminate the Dexycu
Agreement in the event of (i) uncured material breach by the other party or (ii) if DEXCYU ceases to have “pass-through”
payment status. In addition, subject to certain limitations, the Company may terminate the Dexycu
Agreement (i) for convenience subject to an extended specified notice period or (ii) in the event Eyepoint undergoes a
change of control. Eyepoint may terminate the Dexycu Agreement , subject to specified
notice periods and specified limitations, if the Company fails to achieve certain minimum sales levels during specified periods.
During the three and nine months ended September 30, 2020, the Company recorded $ 7 in commission revenues related to the Dexycu
Agreement.
Sales
and Marketing Agreements
The
Company has entered various sales and marketing agreements with certain organizations, to provide exclusive sales and marketing
representation services to Harrow in select geographies in the U.S., in connection with our ophthalmic compounded formulations.
Under
the terms of the sales and marketing agreements, the Company is required to make commission payments equal to 10% to 14% of net
sales for products above and beyond the initial existing sales amounts. In addition, the Company is required to issue shares of
the Company’s restricted common stock to certain organizations if net sales in the assigned territory reach certain future
milestone levels by the end of their terms, as applicable. Commission expenses of $ 741 and $ 1,745 were incurred under these agreements
during the three and nine months ended September 30, 2020, respectively, of which $ 0 and $ 83 were stock-based payments.
26
Asset
Purchase, License and Related Agreements
The
Company has acquired and sourced intellectual property rights related to certain proprietary innovations from certain inventors
and related parties (the “Inventors”) through multiple asset purchase agreements, license agreements, strategic agreements
and commission agreements. In general, these agreements provide that the Inventors will cooperate with the Company in obtaining
patent protection for the acquired intellectual property and that the Company will use commercially reasonable efforts to research,
develop and commercialize a product based on the acquired intellectual property. In addition, the Company has acquired a right
of first refusal on additional intellectual property and drug development opportunities presented by these Inventors.
In
consideration for the acquisition of the intellectual property rights, the Company is obligated to make payments to the Inventors
based on the completion of certain milestones, generally consisting of: (1) a payment payable within 30 days after the issuance
of the first patent in the United States arising from the acquired intellectual property (if any); (2) a payment payable within
30 days after the Company files the first investigational new drug application (“IND”) with the U.S. Food and Drug
Administration (“FDA”) for the first product arising from the acquired intellectual property (if any); (3) for certain
of the Inventors, a payment payable within 30 days after the Company files the first new drug application with the FDA for the
first product arising from the acquired intellectual property (if any); and (4) certain royalty payments based on the net receipts
received by the Company in connection with the sale or licensing of any product based on the acquired intellectual property (if
any), after deducting (among other things) the Company’s development costs associated with such product. If, following five
years after the date of the applicable asset purchase agreement, the Company either (a) for certain of the Inventors, has not
filed an IND or, for the remaining Inventors, has not initiated a study where data is derived, or (b) has failed to generate royalty
payments to the Inventors for any product based on the acquired intellectual property, the Inventors may terminate the applicable
asset purchase agreement and request that the Company re-assign the acquired technology to the Inventors. Royalty expenses of
$ 159
and $ 420
and $ 207
and $ 672
were incurred under these agreements for
the three and nine months ended September 30, 2020 and 2019, respectively, and $ 590
and $ 207
are included in accounts payable at September
30, 2020 and 2019, respectively.
NOTE
15. SEGMENT INFORMATION AND CONCENTRATIONS
Management
evaluates performance of the Company based on operating segments. Segment performance for its two operating segments is based
on segment contribution. The Company’s reportable segments consist of (i) its commercial stage pharmaceutical compounding
business (Pharmaceutical Compounding), generally including the operations of the ImprimisRx business; and (ii) its start-up operations
associated with pharmaceutical drug development business (Pharmaceutical Drug Development). Segment contribution for the segments
represents net revenues less cost of sales, research and development, selling and marketing expenses, and select general and administrative
expenses. The Company does not evaluate the following items at the segment level:
●
Selling,
general and administrative expenses that result from shared infrastructure, including certain expenses associated with legal
matters, public company costs (e.g. investor relations), board of directors and principal executive officers and other like
shared expenses.
●
Operating
expenses within selling, general and administrative expenses that result from the impact of corporate initiatives. Corporate
initiatives primarily include integration, restructuring, acquisition and other shared costs.
●
Other
select revenues and operating expenses including R&D expenses, amortization, and asset sales and impairments, net as not
all such information has been accounted for at the segment level, or such information has not been used by all segments.
●
Total
assets including capital expenditures.
The
Company defines segment net revenues as pharmaceutical compounded drug sales, licenses and other revenue derived from related
agreements.
Cost
of sales within segment contribution includes direct and indirect costs to manufacture formulations and sell products, including
active pharmaceutical ingredients, personnel costs, packaging, storage, royalties, shipping and handling costs, manufacturing
equipment and tenant improvements depreciation, the write-off of obsolete inventory and other related expenses.
27
Selling,
general and administrative expenses consist mainly of personnel-related costs, marketing and promotion costs, distribution costs,
professional service costs, insurance, depreciation, facilities costs, transaction costs, and professional services costs which
are general in nature and attributable to the segment.
Segment
net revenues, segment operating expenses and segment contribution information consisted of the following for the three and nine
months ended September 30, 2020:
SCHEDULE OF SEGMENT NET REVENUES, SEGMENT OPERATING EXPENSES AND SEGMENT CONTRIBUTION
For
the Three Months Ended September 30, 2020
Pharmaceutical
Pharmaceutical
Compounding
Drug
Development
Total
Net revenues
$ 14,399
$ -
$ 14,399
Cost of sales
( 3,696 )
-
( 3,696 )
Gross profit
10,703
-
10,703
Operating expenses:
Selling, general
and administrative
5,893
44
5,937
Research and development
94
22
116
Segment contribution
$ 4,716
$ ( 66 )
4,650
Corporate
2,460
Research and development
554
Amortization
39
Asset sales and impairments, net
-
Operating income
$ 1,597
For
the Nine Months ended September 30, 2020
Pharmaceutical
Pharmaceutical
Compounding
Drug
Development
Total
Net revenues
$ 34,276
$ -
$ 34,276
Cost of sales
( 10,526 )
-
( 10,526 )
Gross profit
23,750
-
23,750
Operating expenses:
Selling,
general and administrative
17,131
131
17,262
Research and development
634
79
713
Segment
contribution
$ 5,985
$ ( 210 )
5,775
Corporate
6,417
Research and development
1,109
Amortization
127
Asset sales and impairments,
net
363
Operating loss
$ ( 2,241 )
28
For
the Three Months Ended September 30, 2019
Pharmaceutical
Pharmaceutical
Compounding
Drug
Development
Total
Net revenues
$ 12,755
$ -
$ 12,755
Cost of sales
( 4,061 )
-
( 4,061 )
Gross profit
8,694
-
8,694
Operating expenses:
Selling, general
and administrative
6,244
44
6,288
Research and development
193
96
289
Segment contribution
$ 2,257
$ ( 140 )
2,117
Corporate
2,280
Research and development
155
Amortization
40
Asset sales and impairments, net
4,040
Operating loss
$ ( 4,398 )
For
the Nine Months Ended September 30, 2019
Pharmaceutical
Pharmaceutical
Compounding
Drug
Development
Total
Net revenues
$ 38,561
$ -
$ 38,561
Cost of sales
( 13,184 )
-
( 13,184 )
Gross profit
25,377
-
25,377
Operating expenses:
Selling, general
and administrative
17,763
130
17,893
Research and development
851
359
1,210
Segment contribution
$ 6,763
$ ( 489 )
6,274
Corporate
7,341
Research and development
449
Amortization
165
Asset sales and impairments, net
4,040
Operating loss
$ ( 5,721 )
The
Company categorizes revenues by geographic area based on selling location. All operations are currently located in the U.S.; therefore,
total revenues are attributed to the U.S. All long-lived assets at September 30, 2020 and December 31, 2019 are located in the
U.S.
The
Company sells its compounded formulations to a large number of customers. No customer accounted for more than 10 % of the Company’s
total pharmacy sales for the three and nine months ended September 30, 2020 and 2019.
The
Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 76 %
and 72 %
of active pharmaceutical ingredient purchases
during the three and nine months ended September 30, 2020, respectively, and 69 %
and 66 %
during the three and nine months ended
September 30, 2019, respectively.
NOTE
16. SUBSEQUENT EVENTS
The
Company has performed an evaluation of events occurring subsequent to September 30, 2020 through the filing date of this Quarterly
Report. Based on its evaluation, no events other than those described herein need to be disclosed.
In
October 2020, the Company issued 93,798 shares of its common stock underlying RSUs held by a director that resigned. The RSUs
had previously vested during the nine months ended September 30, 2020, but the issuance and delivery of the shares were deferred
until the director resigned.
29
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.