Item 1. Financial Statements
Item
1. Financial Statements
HARROW
HEALTH, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except share data)
September
30,
December
31,
2021
2020
(unaudited)
ASSETS
Current
assets
Cash
and cash equivalents, including restricted cash of $ 200
$ 57,856
$ 4,301
Investment
in Eton Pharmaceuticals
9,989
28,455
Note
receivable - Melt Pharmaceuticals
13,636
-
Accounts
receivable, net
4,158
2,662
Inventories
3,925
3,962
Prepaid
expenses and other current assets
1,562
1,602
Total
current assets
91,126
40,982
Property,
plant and equipment, net
4,827
4,453
Operating
lease right-of-use assets
4,624
6,799
Intangible
assets, net
1,892
1,939
Investment
in Surface Ophthalmics
-
1,314
Investment
in Melt Pharmaceuticals
-
1,655
Goodwill
332
332
TOTAL
ASSETS
$ 102,801
$ 57,474
LIABILITIES
AND STOCKHOLDERS’ EQUITY
Current
liabilities
Accounts
payable and accrued expenses
$ 7,335
$ 3,932
Accrued
payroll and related liabilities
2,743
2,315
Deferred
revenue and customer deposits
3
66
Current
portion of paycheck protection program loan payable
-
1,259
Current
portion of loan payable, net of unamortized debt discount
-
2,639
Current
portion of operating lease liabilities
388
580
Current
portion of finance lease obligations
8
8
Total
current liabilities
10,477
10,799
Operating
lease liabilities, net of current portion
4,621
6,652
Finance
lease obligations
12
17
Accrued
expenses, net of current portion
-
800
Paycheck
protection program loan payable, net of current portion
-
708
Loan
payable, net of current portion and unamortized debt discount
71,457
11,670
TOTAL
LIABILITIES
86,567
30,646
COMMITMENTS
AND CONTINGENCIES
-
STOCKHOLDERS’
EQUITY
Common stock, $ 0.001 par value,
50,000,000 shares authorized, 26,902,763 and 25,749,875 shares issued and outstanding at
September 30, 2021 and December 31, 2020, respectively
27
26
Additional
paid-in capital
104,551
104,557
Accumulated
deficit
( 87,989 )
( 77,400 )
TOTAL
HARROW HEALTH STOCKHOLDERS’ EQUITY
16,589
27,183
Noncontrolling
interests
( 355 )
( 355 )
TOTAL
EQUITY
16,234
26,828
TOTAL
LIABILITIES AND EQUITY
$ 102,801
$ 57,474
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)
For
the Three Months Ended
For
the Nine Months Ended
September
30,
September
30,
2021
2020
2021
2020
Revenues:
Sales,
net
$ 17,811
$ 14,385
$ 50,056
$ 34,244
Other
revenues
900
14
2,232
32
Total
revenues
18,711
14,399
52,288
34,276
Cost
of sales
( 4,947 )
( 3,696 )
( 13,134 )
( 10,526 )
Gross
profit
13,764
10,703
39,154
23,750
Operating
expenses:
Selling,
general and administrative
11,356
8,436
28,643
23,806
Research
and development
6,125
670
7,142
1,822
Impairment
of intangible assets
-
-
-
363
Total
operating expenses
17,481
9,106
35,785
25,991
(Loss)
income from operations
( 3,717 )
1,597
3,369
( 2,241 )
Other
(expense) income:
Interest
expense, net
( 1,685 )
( 498 )
( 3,512 )
( 1,563 )
Equity
in losses of unconsolidated entities
( 706 )
( 1,056 )
( 2,967 )
( 3,230 )
Investment
(loss) gain from Eton Pharmaceuticals, net
( 2,220 )
8,575
( 8,639 )
2,450
Loss
from early extinguishment of loan
-
-
( 756 )
-
Gain
on forgiveness of PPP loan
-
-
1,967
-
Other
(expense) income, net
-
5
( 51 )
24
Total
other (expense) income, net
( 4,611 )
7,026
( 13,958 )
( 2,319 )
Total
net (loss) income including noncontrolling interests
( 8,328 )
8,623
( 10,589 )
( 4,560 )
Net
loss attributable to noncontrolling interest
-
15
-
54
Net
(loss) income attributable to Harrow Health, Inc.
$ ( 8,328 )
$ 8,638
$ ( 10,589 )
$ ( 4,506 )
Preferred
dividends and accretion of preferred stock issuance costs
-
-
( 472 )
-
Net
(loss) income attributable to common stockholders
( 8,328 )
8,638
( 11,061 )
( 4,506 )
Basic
net (loss) income per share of common stock
$ ( 0.31 )
$ 0.33
$ ( 0.42 )
$ ( 0.17 )
Diluted
net (loss) income per share of common stock
$ ( 0.31 )
$ 0.32
$ ( 0.42 )
$ ( 0.17 )
Weighted
average number of shares of common stock outstanding, basic
27,112,531
25,921,573
26,626,722
25,880,554
Weighted
average number of shares of common stock outstanding, diluted
27,112,531
27,090,060
26,626,722
25,880,554
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
4
HARROW
HEALTH, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
For
the period ended September 30, 2021 and 2020
(In
thousands, except for share data)
Total
Preferred
Stock
Common
Stock
Additional
Harrow
Health, Inc.
Total
Noncontrolling
Total
Par
Par
Paid-in
Accumulated
Stockholders’
Interest
Stockholders’
Shares
Value
Shares
Value
Capital
Deficit
Equity
Equity
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
-
-
2,998
-
( 8 )
-
( 8 )
-
( 8 )
Exercise
of warrants
Exercise
of warrants , shares
Issuance
of common stock related to vesting of RSUs
Issuance
of common stock related to vesting of RSUs , shares
Shares withheld related to net share settlement of equity awards
Shares withheld related to net share settlement of equity awards
Issuance
of preferred shares, net of discount and issuance costs
Issuance
of preferred shares, net of discount and issuance costs
Redemption
of preferred shares
Redemption
of preferred shares
Payment
of preferred dividends
Stock-based
payment for services provided
Stock-based
payment for services provided
Vesting
of RSUs
Vesting
of RSUs, shares
Stock-based
payment for services provided
-
-
-
-
Stock-based
compensation expense
-
-
-
-
917
-
917
-
917
Net
income
-
-
-
-
-
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
Preferred
Stock
Common
Stock
Additional
Harrow
Health, Inc.
Total
Noncontrolling
Total
Par
Par
Paid-in
Accumulated
Stockholders’
Interest
Stockholders’
Shares
Value
Shares
Value
Capital
Deficit
Equity
Equity
Equity
Balance
at June 30, 2021
-
$ -
26,893,896
$ 27
$ 102,837
$ ( 79,661 )
$ 23,203
$ ( 355 )
$ 22,848
Issuance
of common stock in connection with:
Exercise
of employee stock-based options
-
-
8,867
-
17
-
17
-
17
Stock-based
compensation expense
-
-
-
-
1,697
-
1,697
-
1,697
Net
loss
-
-
-
-
-
( 8,328 )
( 8,328 )
-
( 8,328 )
Balance
at September 30, 2021
-
$ -
26,902,763
$ 27
$ 104,551
$ ( 87,989 )
$ 16,589
$ ( 355 )
$ 16,234
Total
Preferred
Stock
Common
Stock
Additional
Harrow
Health, Inc.
Total
Noncontrolling
Total
Par
Par
Paid-in
Accumulated
Stockholders’
Interest
Stockholders’
Shares
Value
Shares
Value
Capital
Deficit
Equity
Equity
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
-
-
3,251
-
( 8 )
-
( 8 )
-
( 8 )
Issuance
of common stock related to 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
Total
Preferred
Stock
Common
Stock
Additional
Harrow
Health, Inc.
Total
Noncontrolling
Total
Par
Par
Paid-in
Accumulated
Stockholders’
Interest
Stockholders’
Shares
Value
Shares
Value
Capital
Deficit
Equity
Equity
Equity
Balance
at December 31, 2020
-
$ -
25,749,875
$ 26
$ 104,557
$ ( 77,400 )
$ 27,183
$ ( 355 )
$ 26,828
Issuance
of common stock in connection with:
Exercise
of employee stock-based options
-
-
25,480
-
65
-
65
-
65
Exercise
of warrants
-
-
311,369
-
-
-
-
-
-
Vesting
of RSUs
-
-
1,207,500
1
( 1 )
-
-
-
-
Shares
withheld related to net share settlement of equity awards
-
-
( 391,461 )
-
( 3,228 )
-
( 3,228 )
-
( 3,228 )
Issuance
of preferred shares, net of discount and issuance costs
440,000
-
-
-
10,655
-
10,655
-
10,655
Redemption
of preferred shares
( 440,000 )
-
-
-
( 11,000 )
-
( 11,000 )
-
( 11,000 )
Payment
of preferred dividends
-
-
-
-
( 127 )
-
( 127 )
-
( 127 )
Stock-based
compensation expense
-
-
-
-
3,630
-
3,630
-
3,630
Net
loss
-
-
-
-
-
( 10,589 )
( 10,589 )
-
( 10,589 )
Balance
at September 30, 2021
-
$ -
26,902,763
$ 27
$ 104,551
$ ( 87,989 )
$ 16,589
$ ( 355 )
$ 16,234
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)
For
the
For
the
Nine
Months Ended
Nine
Months Ended
September
30,
September
30,
2021
2020
CASH
FLOWS FROM OPERATING ACTIVITIES
Net
loss (including noncontrolling interests)
$ ( 10,589 )
$ ( 4,560 )
Adjustments
to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation
and amortization of property, plant and equipment
1,275
1,377
Amortization
of intangible assets
122
127
Amortization
of operating lease right-of-use assets
422
550
Provision
for bad debt expense
36
221
Amortization
of debt issuance costs and discount
480
354
Gain
on forgiveness of PPP loan
( 1,967 )
-
Investment
loss from Eton, net
8,639
( 2,450 )
Equity
in losses of unconsolidated entities
2,967
3,230
Interest
income paid-in-kind from note receivable
( 136 )
-
Loss
on sale and disposal of assets
-
5
Interest
paid-in-kind on loan payable
-
348
Impairment
of long-lived assets
-
363
Loss
on early extinguishment of loan
706
-
Stock-based
payment of consulting services
-
83
Stock-based
compensation
3,630
1,995
Changes
in assets and liabilities:
Accounts
receivable
( 1,532 )
( 407 )
Inventories
37
( 673 )
Prepaid
expenses and other current assets
( 866 )
( 123 )
Accounts
payable and accrued expenses
2,983
( 2,555 )
Accrued
payroll and related liabilities
428
1,575
Deferred
revenue and customer deposits
( 63 )
6
NET
CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES
6,572
( 534 )
CASH
FLOWS FROM INVESTING ACTIVITIES
Net
proceeds on sale investments
9,827
-
Issuance
of note receivable, Melt Pharmaceuticals
( 12,592 )
-
Investment
in patent and trademark assets
( 75 )
( 111 )
Purchases
of property, plant and equipment
( 1,649 )
( 780 )
NET
CASH USED IN INVESTING ACTIVITIES
( 4,489 )
( 891 )
CASH
FLOWS FROM FINANCING ACTIVITIES
Payments
on finance lease obligations
( 5 )
( 6 )
Net
proceeds from 8.625% notes payable, net of costs
71,073
-
Principal
and exit fee payments on SWK loan
( 15,961 )
( 750 )
Net
proceeds from PPP loan payable
-
1,967
Proceeds
from SWK debt, net of costs
-
1,000
Payment
of taxes upon vesting of RSUs
( 3,228 )
Proceeds
from exercise of stock options
65
( 8 )
Sale
of preferred stock, net of discount and issuance costs
10,655
-
Repayment
of preferred stock
( 11,000 )
-
Payment
of preferred stock dividends
( 127 )
-
NET
CASH PROVIDED BY FINANCING ACTIVITIES
51,472
2,203
NET
CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
53,555
778
CASH,
CASH EQUIVALENTS AND RESTRICTED CASH, beginning of period
4,301
4,949
CASH,
CASH EQUIVALENTS AND RESTRICTED CASH, end of period
$ 57,856
$ 5,727
RECONCILIATION
OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH
Cash
and cash equivalents
$ 57,656
$ 5,527
Restricted
cash
200
200
CASH,
CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD
$ 57,856
$ 5,727
SUPPLEMENTAL
DISCLOSURE OF CASH FLOW INFORMATION:
Cash
paid for income taxes
$ -
$ -
Cash
paid for interest
$ 2,603
$ 1,222
SUPPLEMENTAL
DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Right-of-use
asset obtained in exchange for lease obligation
$ -
$ 936
Net
reduction in right-of-use assets and lease obligations due to
modifications
$ 1,753
$ -
Issuance
of common stock upon vesting of RSUs
$ 1
$ -
Melt
accounts receivable transferred to note receivable
$ 908
$ -
The
accompanying notes are an integral part of these 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, 2021 and 2020
(All
dollar amounts are expressed 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”) is an ophthalmic-focused healthcare company that 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 non-controlling equity positions in Surface Ophthalmics,
Inc. (“Surface”) and Melt Pharmaceuticals, Inc. (“Melt”), both companies that began as subsidiaries of Harrow.
In 2020, Harrow created Visionology, Inc. (“Visionology”), which recently launched an online eye health platform business.
Harrow also owns royalty rights in various drug candidates being developed by Surface and Melt.
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, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021 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, 2020.
The
accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned and majority-owned
subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
Harrow
consolidates entities in which it has a controlling financial interest. The Company consolidates subsidiaries in which it holds and/or
controls, 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, 2021 and December 31, 2020 and the condensed consolidated statements of operations,
stockholders’ equity and cash flows for the periods ended September 30, 2021 and 2020 include our accounts and those of our wholly
owned subsidiaries, as well as our majority owned subsidiaries Mayfield Pharmaceuticals, Inc. (“Mayfield”) and Stowe Pharmaceuticals,
Inc. (“Stowe”).
NOTE
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The
following represents an update for the nine months ended September 30, 2021 to the significant accounting policies described in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2020.
Risks,
Uncertainties and Liquidity
The
Company is subject to certain regulatory standards, approvals, guidelines and inspections which could impact the Company’s ability
to make, dispense, and sell certain products. If the Company was required to cease compounding and selling certain products as a result
of regulatory guidelines or inspections, this may have a material impact on the Company’s financial condition, liquidity and results
of operations.
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 of our operating segments. The Company has identified two operating segments as reportable segments. See
Note 16 for more information regarding the Company’s reportable segments.
7
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 loss attributable
to noncontrolling interests in consolidated net loss on the face of the condensed consolidated statements of operations.
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
interest 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 (loss) income per common share is computed by dividing net (loss) income attributable to common stockholders for the period by the
weighted average number of common shares outstanding during the period. Diluted net (loss) income per share is computed by dividing the
net (loss) income attributable to common stockholders for the period by the weighted average number of common and common equivalent shares,
such as stock options and warrants, outstanding during the period. Common equivalent shares (using the treasury stock method) from stock
options, unvested restricted stock units (“RSUs”) and warrants were 5,657,046 and 5,447,716 at September 30, 2021 and September
30, 2020, respectively. For the three and nine months ended September 30, 2021 and the nine months ended September 30, 2020, the common
equivalent shares are excluded in the calculation of diluted net loss per share because the effect is anti-dilutive. Included in the
basic and diluted net (loss) income 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, 2021 and 2020 was
258,117 and 281,507 , respectively.
The
following table shows the computation of basic and diluted net (loss) income per share of common stock for the three and nine months
ended September 30, 2021 and 2020:
SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE
For the Three
Months Ended
For the Nine
Months Ended
September
30,
September
30,
2021
2020
2021
2020
Numerator
– net (loss) income attributable to Harrow Health, Inc. common stockholders
$ ( 8,328 )
$ 8,638
$ ( 11,061 )
$ ( 4,506 )
Denominator - weighted average number
of shares outstanding, basic
27,112,531
25,921,573
26,626,722
25,880,554
Net
(loss) income per share, basic
$ ( 0.31 )
$ 0.33
$ ( 0.42 )
$ ( 0.17 )
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
8
The
following table shows the computation of diluted net (loss) income per share of common stock for the three and nine months ended September
30, 2021 and 2020:
SCHEDULE
OF DILUTED NET INCOME LOSS PER SHARES
For the Three
Months Ended
For the Nine
Months Ended
September
30,
September
30,
2021
2020
2021
2020
Numerator
– net (loss) income attributable to Harrow Health, Inc.
$ ( 8,328 )
$ 8,638
$ ( 11,061 )
$ ( 4,506 )
Denominator – weighted average number of shares outstanding, basic
27,112,531
25,921,573
26,626,722
25,880,554
Dilutive common equivalent
shares
-
1,168,487
-
-
Number of shares used
for diluted earnings per share computation
27,112,531
27,090,060
26,626,722
25,880,554
Net (loss) income per
share, diluted
$ ( 0.31 )
$ 0.32
$ ( 0.42 )
$ ( 0.17 )
Investment
in Eton Pharmaceuticals, Inc.
During
the nine months ended September 30, 2021, the Company sold 1,518,000 shares of its Eton Pharmaceuticals, Inc. (“Eton”) common
stock through an underwritten public offering at a public offering price of $ 7.00 per share (the
“Eton Stock Sale”). The gross proceeds to the Company from the Eton Stock Sale were $ 10,626 , before deducting underwriting
discounts and commissions and other offering expenses payable by the Company of $ 799 . During the nine months ended September 30, 2021,
the Company recorded a realized loss of $ 1,406 related to the Eton Stock Sale.
Following
the Eton Stock Sale and as of September 30, 2021, the Company owns 1,982,000 shares of Eton common stock, which represents less than
10 % of the equity interests of Eton. At September 30, 2021, the fair market value of Eton’s common stock was $ 5.04 per share. In
accordance with the Accounting Standards Update (“ASU”) 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition
and Measurement of Financial Assets and Financial Liabilities , the Company recorded an unrealized investment gain (loss) from its
Eton common stock position of $ ( 2,220 ) and $ ( 7,233 ) , during the three and nine months ended September 30, 2021, respectively, and $ 8,575
and $ 2,450 during the three and nine months ended September 30, 2020, respectively, related to the change in fair market value of its
investment in Eton during the measurement period. As of September 30, 2021, the fair market value of the Company’s investment in
Eton was $ 9,989 .
As
part of the Eton Stock Sale, the Company agreed, for a period of 180 days, not to conduct any further sales of shares of its common stock
of Eton or otherwise dispose of, directly or indirectly, any common stock of Eton (or any securities convertible into, or exercisable
or exchangeable for, the common stock of Eton).
Investment
in Melt Pharmaceuticals, Inc. – Related Party
The
Company owns 3,500,000 common shares (which is approximately 46 % of the equity interests as of September 30, 2021) of Melt 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.
During the three months ended September 30, 2021 and 2020, the Company recorded equity in the net losses of Melt of $ 706 and $ 300 , and
$ 1,653 and $ 1,536 during the nine months ended September 30, 2021 and 2020, respectively. As of September 30, 2021 and December 31, 2020,
the Company’s investment in Melt was $ 0 and $ 1,655 . At September 30, 2021 and December 31, 2020, the Company recorded $ 8 and $ 851 ,
respectively, due from Melt for reimbursable expenses and amounts due under a Management Services Agreement between the Company and Melt
(the “Melt MSA”), which are included in prepaid expenses and other current assets in the accompanying consolidated balance
sheets.
See
Note 4 for more information and related party disclosure regarding Melt.
9
Investment
in Surface Ophthalmics, Inc. – Related Party
The
Company owns 3,500,000 common shares (which is approximately 20 % of the equity interests following the close of a round of financing
completed by Surface in July 2021) 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 losses of Surface of
$ 0 and $ 756 during the three months ended September 30, 2021 and 2020, respectively, and $ 1,314 and $ 1,694 during the nine months ended
September 30, 2021 and 2020, respectively. As of September 30, 2021 and December 31, 2020, the Company’s investment in Surface
was $ 0 and $ 1,314 , respectively.
See
Note 5 for more information and related party disclosure regarding Surface.
Impairment
of Equity Method Investments and Note Receivable
On
a quarterly basis, management assesses whether there are any indicators that the carrying value of the Company’s equity method
investments and note receivable may be other than temporarily impaired. Indicators include financial condition, operating performance,
and near-term prospects of the investee. To the extent indicators suggest that a loss in value may have occurred, the Company will evaluate
both quantitative and qualitative factors to determine if the loss in value is other than temporary. If a potential loss in value is
determined to be other than temporary, the Company will recognize an impairment loss based on the estimated fair value of the equity
method investments and note receivable. At September 30, 2021 and December 31, 2020, no indicators of impairment existed.
Research
and Development
Research
and development (“R&D”) expenses consist of expenses incurred in performing research and development activities, including
salaries and benefits, other overhead expenses, and costs related to clinical trials, contract services and outsourced contracts. We
expense all costs related to R&D as they are incurred.
Upfront
and milestone payments related to the acquisition and licensing of technology for drug and product candidates that are not yet approved
by the FDA are considered acquisition of in process R&D and expensed as R&D in the period in which the expense occurs.
Recently
Adopted Accounting Pronouncements
In
December 2019, the FASB issued ASU 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes , which simplifies the accounting
for income taxes. This guidance became effective for the Company on January 1, 2021 on a prospective basis. Adoption of this ASU did
not have a material impact on the Company’s condensed consolidated financial statements.
Reclassifications
Certain
prior period items and amounts have been reclassified to conform to the classifications used to prepare the consolidated financial statements
for the current period. These reclassifications had no material impact on the Company’s consolidated financial position,
results of operations, or cash flows as previously reported.
NOTE
3. REVENUES
The
Company accounts for contracts with customers in accordance with ASC 606, Revenues from Contracts with Customers . The Company
has three primary streams of revenue: (1) revenue recognized from our sale of products within our pharmacy services, (2) revenue recognized
from a commission agreement with a third party and (3) revenue recognized from intellectual property license and asset purchase agreements.
10
Product
Revenues from Pharmacy Services
The
Company sells prescription drugs directly through our pharmacy and outsourcing facility network. Revenue 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 principles 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 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 year ended December 31, 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
As
of September 30, 2021, we are party to four intellectual property licenses and asset purchase agreements in which we have agreed to grant
a license and which provide a customer with the right to access the Company’s intellectual property. License arrangements may consist
of 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 in time at which the performance obligation is met.
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.
11
Revenue
disaggregated by revenue source for the three and nine months ended September 30, 2021 and 2020, consists of the following:
SCHEDULE OF DISAGGREGATED REVENUE
For the Three
Months Ended
For the Nine
Months Ended
September
30,
September
30,
2021
2020
2021
2020
Product sales,
net
$ 17,811
$ 14,385
$ 50,056
$ 34,244
Commission revenues
900
-
2,212
-
License
revenues
-
14
20
32
Total
revenues
$ 18,711
$ 14,399
$ 52,288
$ 34,276
Deferred
revenue and customer deposits at September 30, 2021 and December 31, 2020, were $ 3 and $ 66 , respectively. All deferred revenue and customer
deposit amounts at December 31, 2020 were recognized as revenue during the nine months ended September 30, 2021.
NOTE
4. INVESTMENT IN, AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC. - 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 mid-single-digit royalty
payments to the Company on 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. (see Note 2).
Investment
in Melt Pharmaceuticals, Inc.
In
February 2019, the Company and Melt entered into 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 is required to pay the Company a monthly
amount of $ 10 . As of September 30, 2021 and December 31, 2020, the Company was due $ 8 and $ 851 , respectively, from Melt for reimbursable
expenses and amounts due under the Melt MSA. Melt did not make any payments to the Company during the three and nine months ended September
30, 2021. The net funds received by Melt excluded $ 908 for amounts owed to the Company for reimbursable expenses and amounts due under
the Melt MSA prior to the effective date of the note receivable (see Note 2).
The
Company’s Chief Executive Officer, Mark L. Baum, was previously a member of the Melt board of directors until his resignation in
September 2021. Following Mr. Baum’s departure, the Company no longer has any representation on Melt’s board of directors.
The
unaudited condensed results of operations information of Melt is summarized below:
SUMMARY OF CONDENSED INCOME STATEMENT
For the Nine
Months Ended
September
30,
2021
2020
Revenues, net
$ -
$ -
Loss from
operations
3,907
3,261
Net loss
$ ( 3,907 )
$ ( 3,261 )
The
unaudited condensed balance sheet information of Melt is summarized below:
SUMMARY OF CONDENSED BALANCE SHEET
At September 30,
At December 31,
2021
2020
Current assets
$ 11,965
$ 2,947
Non-current assets
-
11
Total
assets
11,965
2,958
Total liabilities
14,273
1,778
Total stockholders’
(deficit) equity
( 2,308 )
1,180
Total
liabilities and stockholders’ equity
$ 11,965
$ 2,958
12
Note
Receivable
In
September 2021, the Company entered into a loan and security agreement in the principal amount of $ 13,500 (the “Melt Loan Agreement”),
as lender, with Melt, as borrower. Amounts borrowed under the Melt Loan Agreement bear interest at twelve and one-half percent ( 12.50 % )
per annum, which interest can be paid in-kind at the option of Melt until the maturity date. The Melt Loan Agreement permits Melt to
pay interest only on the principal amount loaned thereunder through the term and all amounts owed will be due and payable on September
1, 2022. Melt may elect to prepay all, but not less than all, of the amounts owed prior to the maturity date at any time without penalty.
Melt
has granted the Company a security interest in substantially all of its personal property, rights and assets, including intellectual
property rights, to secure the payment of all amounts owed under the Melt Loan Agreement. The Melt Loan Agreement contains customary
representations, warranties and covenants, including covenants by Melt limiting additional indebtedness, liens, mergers and acquisitions,
dispositions, investments, distributions, subordinated debt, and transactions with affiliates. The Melt Loan Agreement includes customary
events of default, and upon the occurrence of an event of default (subject to cure periods for certain events of default), all amounts
owed by Melt thereunder may be declared immediately due and payable by the Company, and the interest rate on the loan may be increased
by three percent (3%) per annum.
In
connection with the Melt Loan Agreement, the Company and Melt entered into a Right of First Refusal Agreement providing the Company with
the right, but not the obligation, to match any offer received by Melt associated with the commercial rights to any of Melt’s drug
candidates for a period of five years following the effective date of the Melt Loan Agreement.
The
net funds received by Melt excluded $ 908 for amounts owed to the Company for reimbursable expenses and amounts due under the Melt MSA
prior to the effective date of the note receivable (see Note 2).
NOTE
5. INVESTMENT IN SURFACE OPHTHALMICS, INC. - 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 associated with Surface’s drug candidates (collectively, the “Surface Products”). Surface
is required to make mid-single-digit royalty payments to the Company on net sales of the Surface Products while any patent rights remain
outstanding.
As
of September 30, 2021, the Company owned 3,500,000 shares of Surface common stock (approximately 20 % of the equity interests). 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 net sales of certain Surface products while certain patent rights remain outstanding. Dr.
Lindstrom is also a minority owner of Flying L Partners, an affiliate of the funding investor who purchased the Surface Series A Preferred
Stock. Several employees and a director of the Company (including Mr. Baum and Dr. Lindstrom) entered into consulting agreements and
provide consulting services to Surface.
13
The
unaudited condensed results of operations information of Surface is summarized below:
SUMMARY OF CONDENSED INCOME STATEMENT
For the Nine
Months Ended
September
30,
2021
2020
Revenues, net
$ -
$ -
Loss from
operations
6,859
5,647
Net loss
$ ( 6,859 )
$ ( 5,647 )
The
unaudited condensed balance sheet information of Surface is summarized below:
SUMMARY OF CONDENSED BALANCE SHEET
At September 30,
At December 31,
2021
2020
Current assets
$ 25,766
$ 9,074
Non-current assets
36
45
Total assets
25,802
9,119
Total liabilities
1,836
1,666
Total stockholders’
equity
23,966
7,453
Total liabilities and
stockholders’ equity
$ 25,802
$ 9,119
NOTE
6. RESTRICTED CASH
The
restricted cash at September 30, 2021 and December 31, 2020 consisted of funds held in a money market account. At September 30, 2021
and December 31, 2020, the restricted cash was recorded at amortized cost, which approximates fair value.
At
September 30, 2021 and December 31, 2020, the funds held in a money market account of $ 200 were classified as a current asset. The money
market account funds are required as collateral as additional security for the Company’s New Jersey facility lease.
NOTE
7. 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, 2021
and December 31, 2020 was as follows:
SCHEDULE OF INVENTORIES
September
30,
2021
December
31,
2020
Raw materials
$ 2,108
$ 2,501
Work in progress
51
17
Finished goods
1,766
1,444
Total inventories
$ 3,925
$ 3,962
NOTE
8. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets at September 30, 2021 and December 31, 2020, consisted of the following:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
September
30,
2021
December
31,
2020
Prepaid insurance
$ 1,001
$ 160
Due from Melt Pharmaceuticals
8
851
Other prepaid expenses
479
401
Deposits and other current
assets
74
190
Total prepaid expenses
and other current assets
$ 1,562
$ 1,602
14
NOTE
9. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment at September 30, 2021 and December 31, 2020, consisted of the following:
SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT
September
30,
2021
December
31,
2020
Property, plant and equipment, net:
Computer software
and hardware
$ 2,494
$ 1,707
Furniture and equipment
442
418
Lab and pharmacy equipment
4,208
3,426
Leasehold
improvements
5,775
5,720
Property, plant and equipment, gross
12,919
11,271
Accumulated depreciation
and amortization
( 8,092 )
( 6,818 )
Property,
plant and equipment, net
$ 4,827
$ 4,453
For
the three and nine months ended September 30, 2021, depreciation and amortization related to the property, plant and equipment was $ 399
and $ 1,275 , respectively. For the three and nine months ended September 30, 2020, depreciation and amortization related to property,
plant and equipment was $ 464 and $ 1,377 , respectively.
NOTE
10. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at September 30, 2021 consisted of the following:
SCHEDULE OF INTANGIBLE ASSETS
Amortization
Periods
(in years)
Cost
Accumulated
Amortization
Impairment
Net
Carrying Value
Patents
17 - 19
$ 542
$ ( 69 )
$ -
$ 473
Licenses
20
100
( 7 )
-
93
Trademarks
Indefinite
359
-
-
359
Customer relationships
3 - 15
1,519
( 553 )
-
966
Trade name
5
5
( 5 )
-
-
Non-competition clause
3 - 4
50
( 50 )
-
-
State pharmacy licenses
25
8
( 7 )
-
1
$ 2,583
$ ( 691 )
$ -
$ 1,892
Amortization
expense for intangible assets for the three and nine months ended September 30, 2021 and 2020 was as follows:
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
For
the
Three
Months Ended
For
the
Nine
Months Ended
September
30,
September
30,
2021
2020
2021
2020
Patents
$ 8
$ 6
$ 20
$ 25
Licenses
1
-
2
1
Customer relationships
34
33
100
101
Amortization of intangible assets
$ 43
$ 39
$ 122
$ 127
Estimated
future amortization expense for the Company’s intangible assets at September 30, 2021 is as follows:
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE
Remainder of 2021
$ 44
2022
188
2023
188
2024
161
2025
148
Thereafter
804
Intangible assets
$ 1,533
NOTE
11. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses consisted of the following:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
September
30,
2021
December
31,
2020
Accounts payable
$ 4,671
$ 3,645
Other accrued expenses
49
49
Accrued litigation settlement (see Note 15)
1,500
-
Accrued interest
1,115
238
Accrued exit fee for
loan payable
-
800
Total accounts payable and accrued expenses
7,335
4,732
Less: Current portion
( 7,335 )
( 3,932 )
Non-current total accrued
expenses
$ -
$ 800
15
NOTE
12. DEBT
8.625%
Senior Notes Due 2026
In
April 2021, the Company closed an offering of $ 50,000 aggregate principal amount of 8.625% senior notes due in April 2026, and in May
2021 issued an additional $ 5,000 of such notes pursuant to the full exercise of the underwriters’ option to purchase additional
notes (collectively, the “April Notes”). The April Notes were sold to investors at a par value of $ 25.00 per April Note and
the offering resulted in net proceeds to the Company of approximately $ 51,909 after deducting underwriting discounts and commissions
and expenses of $ 3,091 . In June 2021, in a further issuance of the April Notes, the Company sold an additional $ 20,000 aggregate principal
amount of such notes (the “June Notes,” and together with the April Notes, the “Notes”), at a price of $ 25.75
per June Note, with interest of $ 278 on the June Notes being accrued from April 20, 2021 as of the date of issuance. The June offering
resulted in net proceeds to the Company of approximately $ 19,164 after deducting underwriting discounts and commissions and expenses
of $ 1,158 and a premium on note issuance of $ 322 . The June Notes are treated as a single series with the April Notes under the indenture
governing the April Notes, dated as of April 20, 2021, and have the same terms as the April Notes (other than the initial offering price
and issue date). T he Notes are senior unsecured obligations of the Company and rank equally
in right of payment with all of our other existing and future senior unsecured and unsubordinated indebtedness. The Notes are effectively
subordinated in right of payment to all of the Company’s existing and future secured indebtedness and structurally subordinated
to all existing and future indebtedness of the Company’s subsidiaries, including trade payables. The Notes bear interest at a rate
of 8.625 % per annum. Interest on the Notes is payable quarterly in arrears on January 31, April 30, July 31 and October 31 of each year,
commencing on July 31, 2021. The Notes will mature on April 30, 2026. The issuance costs were recorded
as a debt discount and are being amortized as interest expense, net of the amortization of the premium on note issuance, over the term
of the Notes using the effective interest rate method.
Prior
to February 1, 2026, the Company may, at its option, redeem the Notes, in whole at any time or in part from time to time, at a redemption
price equal to 100% of the principal amount of the Notes to be redeemed , plus a make-whole amount, if any, plus accrued and unpaid interest
to, but excluding, the date of redemption. The Company may redeem the Notes for cash in whole or in part at any time at our option on
or after February 1, 2026 and prior to maturity, at a price equal to 100% of their principal amount, plus accrued and unpaid interest
to, but excluding, the date of redemption. On and after any redemption date, interest will cease to accrue on the redeemed Notes.
Interest
expense related to the Notes totaled $ 1,464 and $ 2,930 for the three and nine months ended September 30, 2021, and included amortization
of debt issuance costs and discount of $ 197 and $ 389 for the three and nine months ended September 30, 2021.
SWK
Senior Note – Paid in April 2021
In
July 2017, the Company and several of its wholly owned subsidiaries 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 were not achieved. The SWK Loan was 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. The SWK Loan bore an interest rate 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 provided 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 had 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.
16
A
summary of the material changes contained in the amendment entered into with SWK in April 2020 was 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 Second Amendment; and
●
The
interest payment of $ 358 due May 14, 2020 was paid in-kind by increasing the principal amount of the term loans by an amount equal
to the interest accrued as of such date.
Interest
expense related to the SWK Loan Agreement, as amended, amounted to $ 0 and $ 647 for the three and nine months ended September 30, 2021,
respectively, and $ 501 and $ 1,566 for the three and nine months ended September 30, 2020, respectively, and included amortization of
debt issuance costs and discounts of $ 0 and $ 96 for the three and nine months ended September 30, 2021, respectively, and $ 111 and $ 354
for the three and nine months ended September 30, 2020, respectively.
In
April 2021, the Company paid $ 15,540 related to all outstanding obligations to SWK under the SWK Loan, including outstanding principal,
accrued interest, accrued exit fee and related expenses and recorded a loss from early extinguishment of $ 756 related to the SWK Loan
during the nine months ended September 30, 2021.
Paycheck
Protection Program Loan – Forgiven in March 2021
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 (the “SBA”).
On March 30, 2021, the Company received a notice of forgiveness of the full balance of the PPP Loan, including all accrued interest,
in accordance with the terms and conditions of the CARES Act. Related to the forgiveness, the Company recorded a gain on the forgiveness
of the PPP Loan for the loan balance of $ 1,967 in the accompanying condensed consolidated statement of operations for the nine months
ended September 30, 2021.
At
September 30, 2021, future minimum payments under the Company’s debt were as follows:
SUMMARY OF FUTURE MINIMUM PAYMENTS
Amount
Remainder of 2021
$ 2,769
2022
6,562
2023
6,562
2024
6,580
2025
6,562
2026
77,158
Total minimum payments
106,193
Less: amount representing
interest payments
( 31,193 )
Notes payable, gross
75,000
Less: unamortized discount,
net of premium
( 3,543 )
Notes payable, net of
unamortized discount
$ 71,457
NOTE
13. LEASES
The
Company leases office and laboratory space under non-cancelable operating leases listed below. These lease agreements have remaining
terms between one to five years and contain various clauses for renewal at the Company’s option.
●
An
operating lease for 10,200 square feet of office space in San Diego, California that expires in December 2021 ;
●
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 another amendment entered into
in May 2021 that extended the term of the lease to July 2027 ; 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.
17
In
May 2021, the Company amended its New Jersey lease to include the addition of 8,926 square feet of space (the “May Lease Amendment”),
which will expire in July 2027 . The Company expects to take possession of this additional space in November 2021, which will trigger
the commencement of the May Lease Amendment. Since the commencement date of the May Lease Amendment is expected to occur after September
30, 2021, right-of-use assets and operating lease liabilities associated with the May Lease Amendment are not included in the Company’s
condensed consolidated balance sheet as of September 30, 2021.
In
May 2021, the Company entered into an operating lease for 5,789
square feet of office space (the “1000
Aviara Lease”) in Carlsbad, California, which will expire in March
2025 . The Company expects to take possession
of this space in December 2021, which will trigger the commencement of the 1000 Aviara Lease. Since the commencement date of the 1000
Aviara Lease is expected to occur after September 30, 2021, right-of-use assets and operating lease liabilities associated with the 1000
Aviara Lease is not included in the Company’s condensed consolidated balance sheet as of September 30, 2021.
At
September 30, 2021, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases
held by the Company were 6.32 % and 14.18 years , respectively.
During
the three and nine months ended September 30, 2021, cash paid for amounts included for the operating lease liabilities was $ 250 and $ 752 ,
respectively, and the Company recorded operating lease expense of $ 203 and $ 705 , included in selling, general and administrative expenses,
respectively.
Future
lease payments under operating leases as of September 30, 2021 were as follows :
SCHEDULE OF FUTURE LEASE PAYMENTS UNDER OPERATING LEASES
Operating
Leases
Remainder of 2021
$ 251
2022
585
2023
600
2024
617
2025
433
Thereafter
5,146
Total minimum lease payments
7,632
Less: amount representing
interest payments
( 2,623 )
Total operating lease liabilities
5,009
Less: current portion,
operating lease liabilities
( 388 )
Operating lease liabilities,
net of current portion
$ 4,621
The
Company also has a finance lease that is included in its lease accounting but is not considered significant.
Future
lease payments under the non-cancelable finance lease as of September 30, 2021 were as follows :
SCHEDULE OF FUTURE LEASE PAYMENTS UNDER FINANCE LEASE
Finance
Leases
Remainder of 2021
$ 2
2022
9
2023
9
2024
1
Total minimum lease payments
21
Less: amount representing
interest payments
( 1 )
Present value of future minimum lease payments
20
Less: current portion,
finance lease obligation
( 8 )
Finance lease obligation,
net of current portion
$ 12
At
September 30, 2021, the incremental borrowing rate and the remaining lease term for the finance lease held by the Company were 6.36 %
and 2.33 years, respectively.
For
the three and nine months ended September 30, 2021, 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, 2021, cash paid and expense recognized for interest expense related to the finance lease
obligation was $ 0 and $ 1 , respectively.
18
NOTE
14. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Preferred
Stock
At
September 30, 2021 and 2020, the Company had 5,000,000 shares of preferred stock, $ 0.001 par value, authorized and no shares of preferred
stock issued and outstanding.
Series
B Cumulative Preferred Stock – Redeemed in June 2021
In
May 2021, the Company sold 440,000 shares of the Company’s Series B Cumulative Preferred Stock, par value $ 0.001 per share and
liquidation preference of $ 25.00 per share (the “Series B Preferred Stock”), for net proceeds of approximately $ 10,655 . The
Series B Preferred Stock was not convertible into our common stock, had no voting rights , except as required by Delaware law, and was
redeemable by the Company at any time. Holders of Series B Preferred Stock were entitled to cumulative cash dividends at the rate of
9.50 % of the $ 25.00 liquidation preference per year; provided, however, that for each thirty (30) day period following May 5, 2021, the
dividend rate increased at various rates, except as otherwise limited by applicable law. Dividends were payable quarterly in arrears,
on or about the 15th of January, April, July and October, beginning on or about July 15, 2021.
In
June 2021, the Company redeemed all of the outstanding shares of the Series B Preferred Stock. The redemption price for the 440,000 shares
of Series B Preferred Stock outstanding was equal to $ 25.00 per share, plus accrued and unpaid dividends, which in aggregate totaled
$ 11,127 . During the three and nine months ended September 30, 2021, the Company recorded preferred stock cash dividends and deemed dividends
equal to $ 0 and $ 472 , respectively.
Common
Stock
During
the nine months ended September 30, 2021, the Company issued 311,369 shares of its common stock upon the cashless exercise of warrants
to purchase 406,539 shares of common stock with exercise prices between $ 1.79 and $ 3.75 per share.
During
the nine months ended September 30, 2021, the Company issued 25,480 shares of its common stock upon the exercise of options to purchase
25,480 shares of common stock with exercise prices between $ 1.70 and $ 4.29 per share and received net proceeds of $ 65 .
During
the nine months ended September 30, 2021, the Company issued 715,871 shares of its common stock to Mark L. Baum, its Chief Executive
Officer, related to the vesting of 1,050,000 performance-based restricted stock units. The Company withheld issuance of 334,129 shares
of common stock valued at $ 2,760 for payroll tax purposes.
During
the nine months ended September 30, 2021, the Company issued 100,168 shares of common stock to Andrew R. Boll, its Chief Financial Officer,
related to the vesting of 157,500 performance-based restricted stock units. The Company withheld issuance of 57,332 shares of common
stock to Mr. Boll for payroll tax purposes valued at $ 468 .
During
the nine months ended September 30, 2021, 57,654 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 applicable director resigns.
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 which was subsequently amended on June 3, 2021 (as amended, the “2017 Plan” together
with the 2007 Plan, the “Plans”). As of September 30, 2021, the 2017 Plan provides for the issuance of a maximum of 6,000,000
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 of 1986, as amended, 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 2,400,592 shares available for future issuances under the 2017 Plan at September 30, 2021.
19
Stock
Options
A
summary of stock option activity under the Plans for the three and nine months ended September 30, 2021 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, 2021
3,030,033
$ 5.43
Options granted
77,000
$ 8.13
Options exercised
( 25,480 )
$ 2.62
Options cancelled/forfeited
( 41,199 )
$ 5.88
Options outstanding – September
30, 2021
3,040,354
$ 5.52
5.03
$ 10,868
Options exercisable
2,403,938
$ 5.07
4.71
$ 9,672
Options vested and expected
to vest
2,976,713
$ 5.48
5.00
$ 10,748
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 shares underlying options with an exercise
price lower than the market price on September 30, 2021, based on the closing price of the Company’s common stock of $ 9.09 on that
date.
During
the nine months ended September 30, 2021, 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, 2021, generally included 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. 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 .
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 factor 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.
The
table below illustrates the fair value per share determined using the Black-Scholes-Merton option pricing model with the following assumptions
used for valuing options granted to employees:
SCHEDULE OF FAIR VALUE ASSUMPTIONS
2021
Weighted-average
fair value of options granted
$ 5.25
Expected
terms (in years)
5 - 6.11
Expected
volatility
69 - 74 %
Risk-free
interest rate
0.39 - 0.45 %
Dividend
yield
-
20
The
following table summarizes information about stock options outstanding and exercisable at September 30, 2021:
SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE
Options Outstanding
Options Exercisable
Range
of Exercise Prices
Number
Outstanding
Weighted
Average
Remaining
Contractual
Life
in Years
Weighted
Average Exercise Price
Number
Exercisable
Weighted
Average Exercise Price
$ 1.47 - $ 2.60
751,763
4.86
$ 2.06
751,350
$ 2.06
$ 2.76 - $ 4.66
505,000
4.96
$ 3.99
454,621
$ 3.98
$ 5.49 - $ 6.36
470,350
6.34
$ 6.12
384,482
$ 6.14
$ 6.64 - $ 8.99
1,313,241
4.68
$ 7.87
813,485
$ 7.95
$ 1.47 - $ 8.99
3,040,354
5.03
$ 5.52
2,403,938
$ 5.07
As
of September 30, 2021, there was approximately $ 1,656 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 5.25 years. The stock-based
compensation for all stock options was $ 355 and $ 1,376 during the three and nine months ended September 30, 2021, respectively.
The
intrinsic value of options exercised during the three and nine months ended September 30, 2021 was $ 69 and $ 146 , respectively.
Restricted
Stock Units/ Performance 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, 2021, 300,000 RSUs with a fair market value of $ 2,670 were issued to certain employees; the RSUs
vest in full on the third anniversary of the grant date.
During
the nine months ended September 30, 2021, the Company’s board of directors were granted 38,576 RSUs with a fair market value of
$ 400 , which vest in equal quarterly installments over one year.
During
the three and nine months ended September 30, 2021, the Company granted 1,567,913
performance stock units (“PSUs”)
to members of its senior management including Mark Baum, Chief Executive Officer, Andrew Boll, Chief Financial Officer, and John Saharek,
President of ImprimisRx , which are subject to the satisfaction of certain market-based and continued service conditions (the “2021
PSUs”). The 2021 PSUs are separated into four tranches and require that the Company achieve and maintain certain levels of total
stockholder returns (“TSR”) ranging from 50% to 175% per share during the five-year period following the grant date. TSR
is based on the aggregate of: (i) the percent increase of the closing price of the Company’s common stock from July 22, 2021; and
(ii) any dividends or like stockholder distributions as specified in the table below. With certain limited exceptions, in addition to
reaching the TSR targets, the employee must be employed with the Company on the second anniversary of the grant date in order for the
2021 PSUs to vest.
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY
Tranche
Number
of Shares
TSR
Target
Share Price*
Tranche
1
223,988
50% or
greater
$ 11.70
Tranche 2
335,981
100% or greater
$ 15.60
Tranche 3
447,975
150% or greater
$ 19.50
Tranche 4
559,969
175% or greater
$ 21.45
*Target
Share Price assumes that no dividends or like distributions are made to shareholders of the Company. If such distributions are made,
the Target Share Price would decrease accordingly, to the benefit of the employee, to account for the dividend/distribution as a part
of TSR.
The
fair value of the 2021 PSUs was $ 10,113 using a Monte Carlo Simulation with a five-year life, 75 % volatility and a risk free interest
rate of 0.72 % . This amount is being amortized over a two-year derived service period.
21
A
summary of the Company’s RSU activity (including PSUs) and related information for the nine months ended September 30, 2021 is
as follows:
SCHEDULE OF WARRANTS ACTIVITY
Number
of RSUs
Weighted
Average Grant Date Fair Value
RSUs unvested - January 1, 2021
1,601,509
$ 3.14
RSUs granted
1,906,489
$ 6.91
RSUs vested
( 1,265,153 )
$ 2.34
RSUs cancelled/forfeited
-
-
RSUs unvested at September 30, 2021
2,242,845
$ 6.80
As
of September 30, 2021, the total unrecognized compensation expense related to unvested RSUs was approximately $ 12,379 , which is expected
to be recognized over a weighted-average period of 1.73 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, 2021 was $ 1,340 and $ 2,167 , 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, 2021 is as follows:
SCHEDULE OF WARRANTS OUTSTANDING AND WARRANTS EXERCISABLE
Number
of Shares Subject to Warrants Outstanding
Weighted
Average Exercise Price
Warrants outstanding - January 1, 2021
780,386
$ 2.12
Granted
-
Exercised
( 406,539 )
2.16
Expired
-
Warrants outstanding
and exercisable - September 30, 2021
373,847
$ 2.08
Weighted average remaining
contractual life of the outstanding warrants in years - September 30, 2021
2.8
Warrants
outstanding and exercisable as of September 30, 2021 are as follows:
Warrant
Series
Issue
Date
Warrants
Outstanding
Exercise
Price
Expiration
Date
Lender warrants
7/19/2017
373,847
$ 2.08
7/19/2024
Subsidiary
Stock-Based Transactions
The
Company recognized $ 2 and $ 87 in stock-based compensation expense related to subsidiary stock options during the three and nine months
ended September 30, 2021, respectively.
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 Three
Months Ended
For the Nine
Months Ended
September
30,
September
30,
2021
2020
2021
2020
Employees - selling, general and
administrative
$ 1,435
$ 740
$ 2,984
$ 1,612
Employees - R&D
144
-
328
-
Directors - selling, general and administrative
118
177
318
370
Consultants - selling,
general and administrative
-
-
-
96
Total
$ 1,697
$ 917
$ 3,630
$ 2,078
22
NOTE
15. COMMITMENTS AND CONTINGENCIES
Legal
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 for the District of Delaware asserting various claims, including 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 claims related to its purported termination of the asset purchase agreement. In October 2019, NDS voluntarily dismissed all but
two claims, leaving only claims related to the scope and performance of the post-termination obligations to be litigated. On November
8, 2021, following a jury trial, the Company and NDS entered into a voluntary settlement agreement (the “Settlement Agreement”)
to resolve all claims and pending matters related to this lawsuit. The Company estimates the Settlement Agreement will result in a single
one-time payment of $ 1,500 to NDS. Except for the one-time payment, the Company does not expect the Settlement Agreement will have any
future material impact on the Company’s consolidated cash flows, financial position, and results of operations. As of September
30, 2021, the Company had accrued an estimate of $ 1,500 in selling, general and administrative expenses owed to NDS as a result of the
Settlement Agreement.
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.
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 Court 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 sought indemnity and contribution
from the Company and Spectrum. In November 2021, the lawsuit involving the Company was resolved. There was no impact to the Company’s
consolidated financial position and results of operations as a result of the resolution of the case for the Company.
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.
23
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, 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 designed 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% - 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 $ 44 and $ 114 were made during the three and nine months ended September
30, 2021, respectively. Payments totaling $ 0 and $ 55 were made during the three and nine months ended September 30, 2020, respectively.
Royalty expense of $ 51 and $ 130 was incurred during the three and nine months ended September 30, 2021, respectively, and $ 51 is included
in accounts payable to Dr. Lindstrom as of September 30, 2021. Royalty expense of $ 38 and $ 94 was incurred during the three and nine
months ended September 30, 2020, respectively.
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 $ 7
and $ 21
in cash during the three and nine months ended
September 30, 2021, respectively. Dr. Lindstrom was paid $ 0
and $ 7
in cash during the three and nine months ended
September 30, 2020, respectively. The Company incurred royalty expense of $ 7
and $ 21
and $ 6 and $ 48 related to the Lindstrom APA during
the three and nine months ended September 30, 2021, and 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 DEXYCU 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 DEXYCU in the U.S.
24
The
Dexycu Agreement expires on August 1, 2025, subject to early termination in accordance with
the terms set forth therein. Either party may terminate the Dexycu Agreement, subject to specified
notice periods and limitations, in the event of (i) uncured material breach by the other party or (ii) if DEXYCU 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, 2021, the Company recorded $900 and $2,212, respectively, 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 and non-exclusive sales and
marketing representation services to Harrow in select geographies in the U.S. in connection with the Company’s ophthalmic pharmaceutical
compounded formulations or related products.
Under
the terms of the sales and marketing agreements, the Company is generally required to make commission payments equal to 10 % - 14 % of
net sales for products above and beyond the initial existing sales amounts. In addition, the Company is required to make periodic milestone
payments to certain organizations in shares of the Company’s restricted common stock if net sales in the assigned territory reach
certain future levels by the end of their terms. Commission expenses of $ 953 and $ 2,766 and $ 741 and $ 1,745 were incurred under these
agreements during the three and nine months ended September 30, 2021, and 2020, respectively.
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 $ 285 and $ 778 and $ 159 and $ 420 were incurred under these agreements for the three and nine months
ended September 30, 2021 and 2020, respectively, and $ 285 and $ 590 are included in accounts payable at September 30, 2021 and 2020, respectively.
Mayfield
Pharmaceuticals MAY-66 License Termination
In
May 2021, Mayfield terminated the License Agreement (the “TGV License”) with TGV-Health, LLC and affiliated entities (collectively,
“TGV”), pursuant to which it acquired intellectual property rights for use in the women’s health field, related to
Mayfield’s proprietary drug candidate MAY-66. Concurrent with the termination, TGV returned to Mayfield 300,000 shares of Mayfield’s
common stock, constituting all of the equity held by TGV. Mayfield has no outstanding or remaining obligations under the TGV License.
25
Mayfield
Pharmaceuticals MAY-44 APA Termination
In
May 2021, Mayfield and Harrow terminated their asset purchase agreement dated January 2020 (the “MAY-44 APA”) for intellectual
property rights associated with Mayfield’s drug candidate MAY-44 with Elle Pharmaceutical LLC (“Elle”). As part of
the termination, Mayfield re-acquired 350,000 shares of its common stock from Elle. Mayfield has no outstanding or remaining obligations
related to the MAY-44 APA.
Stowe
License Termination
In
May 2021, Stowe terminated the License Agreement (the “Stowe License”) with TGV, pursuant to which it acquired intellectual
property rights for use in the ophthalmic field, related to Stowe’s proprietary drug candidate STE-006. Concurrent with the termination,
TGV returned to Stowe 1,750,000 shares of Stowe’s common stock, constituting all of the equity held by TGV. Stowe has no outstanding
or remaining obligations under the Stowe License.
Sintetica
Agreement
In
July 2021, the Company entered into a License and Supply Agreement (the “Sintetica Agreement”) with Sintetica S.A. (“Sintetica”),
pursuant to which Sintetica granted the Company the exclusive license and marketing rights to its patented ophthalmic drug candidate
(“AMP-100”) in the U.S. and Canada.
Pursuant
to the Sintetica Agreement, the Company will pay Sintetica a per unit transfer price to supply AMP-100, along with a per unit royalty
for units sold. The Company is required to pay Sintetica up to $ 18,000 in one-time milestone payments including a $ 5,000 payment (the
“Upfront Payment”) due within 30 days of signing the Sintetica Agreement and the balance of payments due upon achievement
of certain regulatory and commercial milestones. Under the terms of the Sintetica Agreement, Sintetica will be responsible for regulatory
filings for AMP-100 in the U.S. The Upfront Payment was paid and recorded as R&D expense during the three and nine months ended September
30, 2021.
Subject
to certain limitations, the term of the Sintetica Agreement is ten years, and allows for a ten-year extension if certain sales thresholds
are met.
Wakamoto
Agreement
In
August 2021, the Company entered into a License Agreement and a Basic Sale and Purchase Agreement (together, the “Wakamoto Agreements”)
with Wakamoto Pharmaceutical Co., Ltd. (“Wakamoto”), pursuant to which Wakamoto granted the Company the exclusive license
and marketing rights to its ophthalmic drug candidate (“MAQ-100”) in the U.S. and Canada.
Pursuant
to the Wakamoto Agreements, Wakamoto will supply MAQ-100 to the Company, and the Company
will pay Wakamoto a per unit transfer price to supply MAQ-100. In addition, the Company is required to pay Wakamoto various one-time
milestone payments totaling up to $ 2,000 upon the achievement of certain regulatory milestones and up to $ 6,200 upon the achievement
of certain commercial milestones. Under the terms of the Agreements, the Company will be responsible for regulatory filings and fees
for MAQ-100 in the U.S. and Canada. Through September 30, 2021, no amounts have been paid or accrued under the Wakamoto agreement.
Subject
to certain limitations, the term of the Agreements is for five years from the date of the FDA’s market approval of MAQ-100 and
allows for a five-year extension if certain unit sales thresholds are met.
NOTE
16. 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 business known as ImprimisRx;
and (ii) its start-up operations associated with its 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.
26
The
Company defines segment net revenues as pharmaceutical compounded drug sales, licenses, commissions 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.
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, 2021 and 2020:
SCHEDULE OF SEGMENT NET REVENUES, SEGMENT OPERATING EXPENSES AND SEGMENT CONTRIBUTION
For
the Three Months Ended September 30, 2021
ImprimisRx
Pharmaceutical
Drug Development
Total
Net revenues
$ 18,711
$ -
$ 18,711
Cost of sales
( 4,947 )
-
( 4,947 )
Gross profit
13,764
-
13,764
Operating expenses:
Selling, general and administrative
6,726
-
6,726
Research
and development
475
5,290
5,765
Segment
contribution
$ 6,563
$ ( 5,290 )
1,273
Corporate
4,587
Research and development
360
Amortization
43
Operating
loss
$ ( 3,717 )
For
the Nine Months Ended September 30, 2021
ImprimisRx
Pharmaceutical
Drug Development
Total
Net revenues
$ 52,288
$ -
$ 52,288
Cost of sales
( 13,134 )
-
( 13,134 )
Gross profit
39,154
-
39,154
Operating expenses:
Selling, general and administrative
18,919
-
18,919
Research
and development
797
5,407
6,204
Segment
contribution
$ 19,438
$ ( 5,407 )
14,031
Corporate
9,602
Research and development
938
Amortization
122
Operating
income
$ 3,369
27
For
the Three Months Ended September 30, 2020
ImprimisRx
Pharmaceutical
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 )
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, 2021 and December 31, 2020 were located in the U.S.
Concentrations
The
Company has two products
that each comprised more than 10% of total revenues during the quarter. These products collectively accounted for 35 %
of revenues during each of the three and nine months ended September
30, 2021.
The
Company sells its compounded formulations to a large number of customers. There were no customers who comprised more than 10% of the
Company’s total pharmacy sales for the three and nine months ended September 30, 2021 and 2020.
The Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 59 %
and 71 % of active pharmaceutical ingredient purchases during the three and nine months ended September 30, 2021, respectively, and 76 %
and 72 % of active pharmaceutical ingredient purchases during the three and nine months ended September 30, 2020, respectively.
NOTE
17. SUBSEQUENT EVENTS
The
Company has performed an evaluation of events occurring subsequent to September 30, 2021 through the filing date of this Quarterly Report.
Based on its evaluation, no events other than those described in the notes hereto need to be disclosed.
28
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.