UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒ QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2021
or
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ___________ to _____________
Commission
File Number: 001-35814
Harrow Health, Inc.
(Exact
name of registrant as specified in its charter)
Delaware
45-0567010
(State
or other jurisdiction of
incorporation
or organization)
(I.R.S.
Employer
Identification
No.)
102 Woodmont Blvd. , Suite 610
Nashville ,
Tennessee
37205
(Address
of principal executive offices)
(Zip
code)
(615)
733-4730
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
on exchange on which registered
Common
Stock, $0.001 par value per share
HROW
The
NASDAQ Global Market
8.625%
Senior Notes due 2026
HROWL
The
NASDAQ Global Market
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by a check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of August 9, 2021, there were 26,893,896 shares of the registrant’s common stock, $0.001 par value, outstanding.
HARROW
HEALTH, INC.
Table
of Contents
Page
Part
I
FINANCIAL INFORMATION
3
Item
1.
Financial Statements (unaudited)
3
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
27
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
38
Item
4.
Controls and Procedures
38
Part
II
OTHER INFORMATION
39
Item
1.
Legal Proceedings
39
Item
1A.
Risk Factors
39
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
42
Item
3.
Defaults Upon Senior Securities
42
Item
4.
Mine Safety Disclosures
42
Item
5.
Other Information
42
Item
6.
Exhibits
42
Signatures
43
2
PART
I
FINANCIAL
INFORMATION
Item
1. Financial Statements
HARROW
HEALTH, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(In
thousands, except share data)
June 30,
December 31,
2021
2020
(unaudited)
ASSETS
Current assets
Cash and cash equivalents, including restricted cash of $ 200
$ 72,851
$ 4,301
Investment in Eton Pharmaceuticals
12,209
28,455
Accounts receivable, net
3,710
2,662
Inventories
3,903
3,962
Prepaid expenses and other current assets
801
751
Total current assets
93,474
40,131
Property, plant and equipment, net
4,937
4,453
Operating lease right-of-use assets
4,747
6,799
Intangible assets, net
1,882
1,939
Investment in Surface Ophthalmics
-
1,314
Investment in Melt Pharmaceuticals
1,594
2,506
Investments
-
-
Goodwill
332
332
TOTAL ASSETS
$ 106,966
$ 57,474
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable and accrued expenses
$ 5,207
$ 3,932
Accrued payroll and related liabilities
2,388
2,315
Deferred revenue and customer deposits
56
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
485
580
Current portion of finance lease obligations
8
8
Total current liabilities
8,144
10,799
Operating lease liabilities, net of current portion
4,695
6,652
Finance lease obligations
14
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
71,265
11,670
TOTAL LIABILITIES
84,118
30,646
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY
Common stock, $ 0.001 par value, 50,000,000 shares authorized, 26,893,896 and 25,749,875 shares issued
and outstanding at June 30, 2021 and December 31, 2020, respectively
27
26
Additional paid-in capital
102,837
104,557
Accumulated deficit
( 79,661 )
( 77,400 )
TOTAL HARROW HEALTH STOCKHOLDERS’ EQUITY
23,203
27,183
Noncontrolling interests
( 355 )
( 355 )
TOTAL EQUITY
22,848
26,828
TOTAL LIABILITIES AND EQUITY
$ 106,966
$ 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 Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Revenues:
Sales, net
$ 17,297
$ 8,049
$ 32,245
$ 19,859
Other revenues
837
11
1,332
18
Total revenues
18,134
8,060
33,577
19,877
Cost of sales
( 4,417 )
( 3,204 )
( 8,187 )
( 6,830 )
Gross profit
13,717
4,856
25,390
13,047
Operating expenses:
Selling, general and administrative
9,123
6,954
17,287
15,370
Research and development
425
749
1,017
1,152
Impairment of intangible assets
-
363
-
363
Total operating expenses
9,548
8,066
18,304
16,885
Income (loss) from operations
4,169
( 3,210 )
7,086
( 3,838 )
Other (expense) income:
Interest expense, net
( 1,314 )
( 505 )
( 1,827 )
( 1,065 )
Investment loss from Melt Pharmaceuticals, net
( 477 )
( 690 )
( 947 )
( 1,236 )
Investment loss from Surface Pharmaceuticals, net
( 465 )
( 599 )
( 1,314 )
( 938 )
Investment (loss) gain from Eton Pharmaceuticals, net
( 3,584 )
4,725
( 6,419 )
( 6,125 )
Investment loss
-
-
-
-
Loss from early extinguishment of loan
( 756 )
-
( 756 )
-
Gain on forgiveness of PPP loan
-
-
1,967
-
Other (expense) income, net
( 51 )
19
( 51 )
19
Total other (expense) income, net
( 6,647 )
2,950
( 9,347 )
( 9,345 )
Total net loss including noncontrolling interests
( 2,478 )
( 260 )
( 2,261 )
( 13,183 )
Net loss attributable to noncontrolling interests
-
23
-
39
Net loss attributable to Harrow Health, Inc.
( 2,478 )
( 237 )
( 2,261 )
( 13,144 )
Preferred dividends and accretion of preferred stock discount
( 472 )
-
( 472 )
-
Net loss attributable to common stockholders
$ ( 2,950 )
$ ( 237 )
$ ( 2,733 )
$ ( 13,144 )
Basic and diluted net loss per share of common stock
$ ( 0.11 )
$ ( 0.01 )
$ ( 0.10 )
$ ( 0.51 )
Weighted average number of shares of common stock outstanding, basic and diluted
26,736,970
25,893,629
26,379,943
25,867,478
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 three and six months ended June 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’
Interests
Stockholders’
Shares
Value
Shares
Value
Capital
Deficit
Equity
Equity
Equity
Balance at March 31, 2020
-
$ -
25,618,918
$ 26
$ 102,261
$ ( 86,950 )
$ 15,337
$ ( 309 )
$ 15,028
Issuance of common stock in connection with:
Exercise of employee stock options
-
-
253
-
-
-
-
-
-
Exercise of warrants
Exercise of warrants, shares
Vesting of RSUs
Vesting of RSUs, shares
Stock-based payment for services provided
-
-
30,000
-
83
-
83
-
83
Shares withheld related to net share settlement of equity awards
Shares withheld related to net share settlement of equity awards, shares
Issuance of preferred shares, net of discount and issuance costs
Issuance of preferred shares, net of discount and issuance
costs, shares
Redemption of preferred shares
Redemption of preferred shares, shares
Payment of preferred dividends
Stock-based compensation expense
-
-
-
-
545
-
545
-
545
Net loss
-
-
-
-
-
( 237 )
( 237 )
( 23 )
( 260 )
Balance at June 30, 2020
-
$ -
25,649,171
$ 26
$ 102,889
$ ( 87,187 )
$ 15,728
$ ( 332 )
$ 15,396
Total
Preferred Stock
Common Stock
Additional
Harrow Health, Inc.
Total
Noncontrolling
Total
Par
Par
Paid-in
Accumulated
Stockholders’
Interests
Stockholders’
Shares
Value
Shares
Value
Capital
Deficit
Equity
Equity
Equity
Balance at March 31, 2021
-
$ -
25,983,676
$ 26
$ 105,382
$ ( 77,183 )
$ 28,225
$ ( 355 )
$ 27,870
Issuance of common stock in connection with:
Exercise of employee stock options
-
-
5,312
-
21
-
21
-
21
Exercise of warrants
-
-
311,369
-
-
-
-
-
-
Vesting of RSUs
-
-
977,500
1
( 1 )
-
-
-
-
Shares withheld related to net share settlement of equity awards
-
-
( 383,961 )
-
( 3,171 )
-
( 3,171 )
-
( 3,171 )
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
-
-
-
-
1,078
-
1,078
-
1,078
Net loss
-
-
-
-
-
( 2,478 )
( 2,478 )
-
( 2,478 )
Balance at June 30, 2021
-
$ -
26,893,896
$ 27
$ 102,837
$ ( 79,661 )
$ 23,203
$ ( 355 )
$ 22,848
Total
Preferred Stock
Common Stock
Additional
Harrow Health, Inc.
Total
Noncontrolling
Total
Par
Par
Paid-in
Accumulated
Stockholders’
Interests
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 options
-
-
253
-
-
-
-
-
-
Vesting of RSUs
91,987
-
-
-
-
-
-
Stock-based payment for services provided
-
-
30,000
-
83
-
83
-
83
Stock-based compensation expense
-
-
-
-
1,078
-
1,078
-
1,078
Net loss
-
-
-
-
-
( 13,144 )
( 13,144 )
( 39 )
( 13,183 )
Balance at June 30, 2020
-
$ -
25,649,171
$ 26
$ 102,889
$ ( 87,187 )
$ 15,728
$ ( 332 )
$ 15,396
Total
Preferred Stock
Common Stock
Additional
Harrow Health, Inc.
Total Noncontrolling
Total
Par
Par
Paid-in
Accumulated
Stockholders’
Interests
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 options
-
-
16,613
-
48
-
48
-
48
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
-
-
-
-
1,933
-
1,933
-
1,933
Net loss
-
-
-
-
-
( 2,261 )
( 2,261 )
-
( 2,261 )
Balance at June 30, 2021
-
$ -
26,893,896
$ 27
$ 102,837
$ ( 79,661 )
$ 23,203
$ ( 355 )
$ 22,848
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
Six Months
Ended
Six Months
Ended
June 30,
June 30,
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss (including noncontrolling interests)
$ ( 2,261 )
$ ( 13,183 )
Adjustments to reconcile net loss to net cash provided by (used in) operating
activities:
Depreciation and amortization of property, plant and equipment
876
913
Amortization of intangible assets
79
88
Amortization of operating lease right-of-use assets
299
341
Provision for bad debt expense
36
302
Amortization of debt issuance costs and discount
288
243
Gain on forgiveness of PPP loan
( 1,967 )
-
Investment loss from Eton Pharmaceuticals, net
6,419
6,125
Investment loss from Surface Opthalmics, net
1,314
938
Investment loss from Melt Pharmaceuticals, net
947
1,236
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
1,933
1,078
Changes in assets and liabilities:
Accounts receivable
( 1,084 )
( 311 )
Inventories
59
( 540 )
Prepaid expenses and other current assets
( 85 )
( 25 )
Accounts payable and accrued expenses
1,026
( 2,253 )
Accrued payroll and related liabilities
73
1,052
Deferred revenue and customer deposits
( 10 )
( 4 )
NET CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES
8,648
( 3,201 )
CASH FLOWS FROM INVESTING ACTIVITIES
Net proceeds on sale investments
9,827
-
Investment in patent and trademark assets
( 22 )
( 74 )
Purchases of property, plant and equipment
( 1,360 )
( 536 )
NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES
8,445
( 610 )
CASH FLOWS FROM FINANCING ACTIVITIES
Payments on finance lease obligations
( 3 )
( 3 )
Net proceeds from 8.625% notes payable, net of costs
71,073
-
Principal and exit fee payments on SWK loan
( 15,961 )
-
Net proceeds from PPP loan
-
1,967
Proceeds from SWK debt, net of costs
-
1,000
Payment of taxes for vesting of RSUs
( 3,228 )
-
Proceeds from exercise of stock options
48
-
Sale of preferred stock, net of discount and issuance costs
10,655
-
Redemption of preferred stock
( 11,000 )
-
Payment of preferred stock dividends
( 127 )
-
NET CASH PROVIDED BY FINANCING ACTIVITIES
51,457
2,964
NET CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
68,550
( 847 )
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, beginning of
period
4,301
4,949
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, end of period
$ 72,851
$ 4,102
RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH
Cash and cash equivalents
$ 72,651
$ 3,902
Restricted cash
200
200
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD
$ 72,851
$ 4,102
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for income taxes
$ -
$ -
Cash paid for interest
$ 788
$ 408
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Right-of-use asset obtained in exchange for lease obligation
$ -
$ 41
Net reduction in right-of-use assets and lease liabilities
in connection with lease modifications
$ 1,753
$ -
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 six months ended June 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”) 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 six months ended June
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 June 30, 2021 and December 31, 2020 and the condensed consolidated statements of operations,
stockholders’ equity and cash flows for the periods ended June 30, 2021 and 2020 include our accounts and those of our wholly owned
subsidiaries, as well as our majority owned subsidiaries Mayfield Pharmaceuticals, Inc. and Stowe Pharmaceuticals, Inc.
NOTE
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The
following represents an update for the six months ended June 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 Loss per Common Share
Basic
net loss per common share is computed by dividing net loss attributable to common stockholders for the period by the weighted average
number of common shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss 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. Basic and diluted net loss per share is computed using the weighted average number of shares of common
stock outstanding during the period. Common equivalent shares (using the treasury stock or “if converted” method) from stock
options, unvested restricted stock units (“RSUs”) and warrants were 4,121,398 and 5,414,504 at June 30, 2021 and 2020, respectively.
For the three and six months ended June 30, 2021 and 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 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 June 30, 2021 and 2020 was 235,973 and 251,746 , respectively.
The
following table shows the computation of basic and diluted net loss per share of common stock for the three and six months ended June
30, 2021 and 2020:
SCHEDULE
OF BASIC AND DILUTED EARNINGS PER COMMON SHARE
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Numerator – net loss attributable to Harrow Health, Inc. common stockholders
$ ( 2,950 )
$ ( 237 )
$ ( 2,733 )
$ ( 13,144 )
Denominator - weighted average number of shares outstanding, basic and diluted
26,736,970
25,893,629
26,379,943
25,867,478
Net loss per share, basic and diluted
$ ( 0.11 )
$ ( 0.01 )
$ ( 0.10 )
$ ( 0.51 )
Investment
in Eton Pharmaceuticals, Inc.
During
the three and six months ended June 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 three and six months ended June 30,
2021, the Company recorded a realized loss of $ 1,406 related to the sale of 1,518,000 shares of its Eton common stock.
8
Following
the Eton Stock Sale and as of June 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 June 30, 2021, the fair market value of Eton’s common stock was $ 6.16 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 $ ( 2,178 ) and $ ( 5,013 ) and $ 4,725 and $ ( 6,125 ) during the three and six months ended June 30, 2021 and 2020,
respectively, related to the change in fair market value of its investment in Eton during the measurement period. As of June 30, 2021,
the fair market value of the Company’s investment in Eton was $ 12,209 .
As
part of the Eton Stock Sale, the Company also 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 44 % of the equity interests as of June 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 June 30, 2021 and 2020, the Company recorded equity in the net losses of Melt of $ 477 and $ 690 , and $ 947
and $ 1,236 during the six months ended June 30, 2021 and 2020, respectively. As of June 30, 2021 and December 31, 2020, the Company’s
investment in Melt was $ 1,594 and $ 2,506 , respectively, which includes $ 885 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”).
See
Note 4 for more information and related party disclosure regarding Melt.
Investment
in Surface Ophthalmics, Inc. – Related Party
The
Company owns 3,500,000
common shares (which is approximately 20 %
of the equity interests following the close of
a round of financing completed by Surface at various dates from May 2021 to 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 $ 465
and $ 599
during the three months and $ 1,314
and $ 938
during the six months ended June 30, 2021 and
2020, respectively. As of June 30, 2021 and December 31, 2020, the Company’s investment in Surface was $ 0
and $ 1,314 ,
respectively.
See
Notes 5 for more information and related party disclosure regarding Surface.
Property,
Plant and Equipment
Property,
plant and equipment is stated at cost less accumulated depreciation and amortization. Depreciation and amortization is calculated using
the straight-line method over the estimated useful life of the asset. Leasehold improvements and capital lease equipment are amortized
over the estimated useful life or remaining lease term, whichever is shorter. Software costs during the application development
stage used to meet the Company’s internal needs are generally capitalized. Computer software and hardware and furniture and equipment
are depreciated over three to five years .
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.
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.
9
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 June 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.
10
Revenue
disaggregated by revenue source for the three and six months ended June 30, 2021 and 2020, consists of the following:
SCHEDULE OF DISAGGREGATED REVENUE
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Product sales, net
$ 17,297
$ 8,049
$ 32,245
$ 19,859
Commission revenues
827
-
1,312
-
License revenues
10
11
20
18
Total revenues
$ 18,134
$ 8,060
$ 33,577
$ 19,877
Deferred
revenue and customer deposits at June 30, 2021 and December 31, 2020, were $ 56 and $ 66 , respectively. All deferred revenue and customer
deposit amounts at December 31, 2020 were recognized as revenue during the six months ended June 30, 2021.
NOTE
4. INVESTMENT IN 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 also Note 2, under the subheading
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 June 30, 2021 and December 31, 2020, the Company was due $ 885 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 six months ended June 30, 2021.
The
Company’s Chief Executive Officer, Mark L. Baum is a member of the Melt board of directors, and several employees of the Company
(including Mr. Baum and the Company’s Chief Financial Officer, Andrew R. Boll) entered into consulting agreements and provide consulting
services to Melt.
The
unaudited condensed results of operations information of Melt is summarized below:
SCHEDULE OF CONDENSED INCOME STATEMENT
For the Six Months Ended
June 30,
2021
2020
Revenues, net
$ -
$ -
Loss from operations
2,177
2,574
Net loss
$ ( 2,177 )
$ ( 2,574 )
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE OF CONDENSED BALANCE SHEET
At June 30,
At December 31,
2021
2020
Current assets
$ 927
$ 2,947
Non current assets
98
11
Total assets
1,025
2,958
Total liabilities
1,784
1,778
Total stockholders’ (deficit) equity
( 759 )
1,180
Total liabilities and stockholders’ equity
$ 1,025
$ 2,958
11
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 June 30, 2021, the Company owned 3,500,000
shares of Surface common stock. 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.
The
unaudited condensed results of operations information of Surface is summarized below:
SUMMARY OF CONDENSED INCOME STATEMENT
For the Six Months Ended
June 30,
2021
2020
Revenues, net
$ -
$ -
Loss from operations
4,712
3,127
Net loss
$ ( 4,712 )
$ ( 3,127 )
The
unaudited condensed balance sheet information of Surface is summarized below:
SUMMARY OF CONDENSED BALANCE SHEET
At June 30,
At December 31,
2021
2020
Current assets
$ 25,786
$ 9,074
Non current assets
43
45
Total assets
25,829
9,119
Total liabilities
1,771
1,666
Total stockholders’ equity
24,058
7,453
Total liabilities and stockholders’ equity
$ 25,829
$ 9,119
NOTE
6. RESTRICTED CASH
The
restricted cash at June 30, 2021 and December 31, 2020 consisted of funds held in a money market account. At June 30, 2021 and December
31, 2020, the restricted cash was recorded at amortized cost, which approximates fair value.
At
June 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.
12
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 June 30, 2021 and December
31, 2020 was as follows:
SCHEDULE OF INVENTORIES
June
30,
2021
December
31,
2020
Raw materials
$ 1,990
$ 2,501
Work in progress
17
17
Finished goods
1,896
1,444
Total inventories
$ 3,903
$ 3,962
NOTE
8. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets at June 30, 2021 and December 31, 2020, consisted of the following:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
June
30,
2021
December
31,
2020
Prepaid insurance
$ 120
$ 160
Other prepaid expenses
607
401
Deposits and other current assets
74
190
Total prepaid expenses and other current assets
$ 801
$ 751
NOTE
9. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment at June 30, 2021 and December 31, 2020, consisted of the following:
SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT
June
30,
2021
December
31,
2020
Property, plant and equipment, net:
Computer software and hardware
$ 1,427
$ 1,370
Internal use software costs in development
803
337
Furniture and equipment
441
418
Lab and pharmacy equipment
4,225
3,426
Leasehold improvements
5,735
5,720
Property, plant and equipment, gross
12,631
11,271
Accumulated depreciation and amortization
( 7,694 )
( 6,818 )
Property,
plant and equipment, net
$ 4,937
$ 4,453
For
the three and six months ended June 30, 2021, depreciation and amortization related to the property, plant and equipment was $ 412 and
$ 876 , respectively. For the three and six months ended June 30, 2020, depreciation and amortization related to the property, plant and
equipment was $ 465 and $ 913 , respectively.
13
NOTE
10. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at June 30, 2021 consisted of the following:
SCHEDULE OF INTANGIBLE ASSETS
Amortization
periods
(in
years)
Cost
Accumulated
amortization
Impairment
Net
carrying
value
Patents
17 - 19
$ 540
$ ( 60 )
$ -
$ 480
Licenses
20
50
( 6 )
-
44
Trademarks
Indefinite
358
-
-
358
Customer relationships
3 - 15
1,519
( 520 )
-
999
Trade name
5
5
( 5 )
-
-
Non-competition clause
3 - 4
50
( 50 )
-
-
State
pharmacy licenses
25
8
( 7 )
-
1
$ 2,530
$ ( 648 )
$ -
$ 1,882
Amortization
expense for intangible assets for the three and six months ended June 30, 2021 and 2020 was as follows:
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
For
the
Three
Months Ended
For
the
Six
Months Ended
June
30,
June
30,
2021
2020
2021
2020
Patents
$ 6
$ 8
$ 12
$ 19
Licenses
-
-
1
1
Customer
relationships
33
35
66
68
$ 39
$ 43
$ 79
$ 8 8
Estimated
future amortization expense for the Company’s intangible assets at June 30, 2021 is as follows:
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE
Remainder of 2021
$ 110
2022
188
2023
188
2024
161
2025
148
Thereafter
729
Intangible
assets
$ 1,524
NOTE
11. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses consisted of the following:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
June
30,
2021
December
31,
2020
Accounts payable
$ 3,882
$ 3,645
Other accrued expenses
49
49
Accrued interest
1,276
238
Accrued exit fee for loan payable
-
800
Total accounts payable and accrued expenses
5,207
4,732
Less: Current portion
( 5,207 )
( 3,932 )
Non-current total accrued expenses
$ -
$ 800
14
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 $ 1,466 for the three and six months ended June 30, 2021, and included amortization of debt issuance
costs and discount of $ 192 for the three and six months ended June 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.
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.
15
Interest
expense related to the SWK Loan Agreement, as amended, amounted to $ 138 and $ 647 for the three and six months ended June 30, 2021, respectively,
and $ 505 and $ 1,065 for the three and six months ended June 30, 2020, respectively, and included amortization of debt issuance costs
and discount of $ 0 and $ 96 for the three and six months ended June 30, 2021, respectively, and $ 83 and $ 243 for the three and six months
ended June 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 three and six months ended June 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 six months ended June 30, 2021.
At
June 30, 2021, future minimum payments under the Company’s debt were as follows:
SUMMARY OF FUTURE MINIMUM PAYMENTS
Amount
Remainder of 2021
$ 3,308
2022
6,562
2023
6,562
2024
6,580
2025
6,562
2026
77,158
Total minimum payments
106,732
Less: amount representing interest payments
( 31,732 )
Notes payable, gross
75,000
Less: unamortized discount, net of premium
( 3,735 )
Notes payable, net of unamortized discount
$ 71,265
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 four 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 .
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 September 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 June 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 sheets as of June 30, 2021.
16
At
June 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 14.08 years, respectively.
During
the three and six months ended June 30, 2021, cash paid for amounts included for the operating lease liabilities was $ 251 and $ 502 , respectively,
and the Company recorded operating lease expense of $ 241 and $ 502 included in selling, general and administrative expenses, respectively.
Future
lease payments under operating leases as of June 30, 2021 were as follows :
SCHEDULE OF FUTURE LEASE PAYMENTS UNDER OPERATING LEASES
Operating
Leases
Remainder of 2021
$ 502
2022
585
2023
600
2024
617
2025
433
Thereafter
5,146
Total minimum lease payments
7,883
Less: amount representing interest payments
( 2,703 )
Total operating lease liabilities
5,180
Less: current portion, operating lease liabilities
( 485 )
Operating lease liabilities, net of current portion
$ 4,695
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 June 30, 2021 were as follows :
SCHEDULE OF FUTURE LEASE PAYMENTS UNDER FINANCE LEASE
Finance
Leases
Remainder of 2021
$ 5
2022
9
2023
9
2024
1
Total minimum lease payments
24
Less: amount representing interest payments
( 2 )
Present value of future minimum lease payments
22
Less: current portion, finance lease obligation
( 8 )
Finance lease obligation, net of current portion
$ 14
At
June 30, 2021, the weighted average incremental borrowing rate and the weighted average remaining lease term for the finance lease held
by the Company were 6.36 % and 2.58 years, respectively.
For
the three and six months ended June 30, 2021, depreciation expense related to the equipment held under the finance lease obligation was
$ 2 and $ 4 , respectively.
For
the three and six months ended June 30, 2021, cash paid and expense recognized for interest expense related to the finance lease obligation
was $ 0 and $ 1 , respectively.
NOTE
14. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Preferred
Stock
At
June 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.
17
Series
B Cumulative Preferred Stock – Redeemed
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 a net purchase price 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 Company’s Series B Preferred Stock, par value $ 0.001 per share.
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 six months ended June 30, 2021, the Company recorded preferred stock
cash dividends and deemed dividends equal to $ 472 .
Common
Stock
During
the six months ended June 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 six months ended June 30, 2021, the Company issued 16,613 shares of its common stock upon the exercise of options to purchase 16,613
shares of common stock with exercise prices between $ 1.70 and $ 4.29 per share and received net proceeds of $ 48 .
During
the six months ended June 30, 2021, the Company issued 715,871 shares of its common stock to Mark L. Baum, its CEO, 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 six months ended June 30, 2021, the Company issued 100,168 shares of common stock to Andrew R. Boll, its CFO, 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 six months ended June 30, 2021, 35,510 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 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 June 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, 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 3,967,251
shares available for future issuances under the 2017 Plan at June 30, 2021.
18
Stock
Options
A
summary of stock option activity under the Plans for the six months ended June 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
67,000
$ 8.07
Options exercised
( 16,613 )
$ 2.99
Options cancelled/forfeited
( 29,945 )
$ 5.32
Options outstanding - June 30, 2021
3,050,475
$ 5.50
5.28
$ 11,555
Options exercisable
2,333,132
$ 5.01
4.85
$ 9,985
Options vested and expected to vest
2,978,866
$ 5.46
5.25
$ 11,399
The
aggregate intrinsic value in the table above represents the total pre-tax amount of the proceeds, net of exercise price, which would
have been received by option holders if all option holders had exercised and immediately sold all options with an exercise price lower
than the market price on June 30, 2021, based on the closing price of the Company’s common stock of $ 9.29 on that date.
During
the six months ended June 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 six months ended June 30, 2021 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
$ 4.96
Expected terms (in years)
6.11
Expected volatility
69 %
Risk-free interest rate
0.39 - 0.45 %
Dividend yield
-
The
following table summarizes information about stock options outstanding and exercisable at June 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
760,318
5.13
$ 2.06
755,208
$ 2.06
$ 2.76 - $ 4.66
506,566
5.22
$ 3.98
449,872
$ 3.98
$ 5.49 - $ 6.36
470,350
6.59
$ 6.12
348,128
$ 6.14
$ 6.64 - $ 8.99
1,313,241
4.93
$ 7.86
779,924
$ 7.96
$ 1.47 - $ 8.99
3,050,475
5.28
$ 5.50
2,333,132
$ 5.01
As
of June 30, 2021, there was approximately $ 2,012 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 5.17 years. The stock-based
compensation for all stock options was $ 569 and $ 1,021 during the three and six months ended June 30, 2021, respectively.
19
The
intrinsic value of options exercised during the three and six months ended June 30, 2021 was $ 14 and $ 77 , respectively.
Restricted
Stock Units
RSU
awards are granted subject to certain vesting requirements and other restrictions, including performance and market-based vesting criteria.
The grant date fair value of the RSUs, which has been determined based upon the market value of the Company’s common stock on the
grant date, is expensed over the vesting period of the RSUs.
During
the six months ended June 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 six months ended June 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.
A
summary of the Company’s RSU activity and related information for the six months ended June 30, 2021 is as follows:
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY
Number of RSUs
Weighted Average Grant Date Fair Value
RSUs unvested - January 1, 2021
1,601,509
$ 3.14
RSUs granted
338,576
$ 9.07
RSUs vested
( 1,243,009 )
$ 2.24
RSUs cancelled/forfeited
-
-
RSUs unvested at June 30, 2021
697,076
$ 7.61
As
of June 30, 2021, the total unrecognized compensation expense related to unvested RSUs was approximately $ 3,606 , which is expected to
be recognized over a weighted-average period of 1.74 years, based on estimated and actual vesting schedules of the applicable RSUs. The
stock-based compensation for RSUs during the three and six months ended June 30, 2021 was $ 481 and $ 827 , 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 six months ended June 30, 2021 is as follows:
SCHEDULE OF WARRANTS ACTIVITY
Number of Shares Subject to Warrants Outstanding
Weighted Avg. Exercise Price
Warrants outstanding - January 1, 2021
780,386
$ 2.12
Granted
-
Exercised
( 406,539 )
2.16
Expired
-
Warrants outstanding and exercisable - June 30, 2021
373,847
$ 2.08
Weighted average remaining contractual life of the outstanding warrants in years - June 30, 2021
3.05
20
Warrants
outstanding and exercisable as of June 30, 2021 are as follows:
SCHEDULE OF WARRANTS OUTSTANDING AND WARRANTS EXERCISABLE
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 $ 28 and $ 85 in stock-based compensation expense related to subsidiary stock options during the three and six months
ended June 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 Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Employees - selling, general and administrative
923
436
1,678
872
Employees - R&D
55
-
55
-
Directors - selling, general and administrative
100
96
200
193
Consultants - selling, general and administrative
-
96
-
96
Total
$ 1,078
$ 628
$ 1,933
$ 1,161
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 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 APA. 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. Trial is currently set to begin in November 2021. NDS
is seeking damages, interest, attorneys’ fees and other costs. The Company believes the claims are meritless and has previously
and will continue to dispute all claims asserted against it and intends to vigorously defend against these allegations. Nonetheless,
the Company cannot predict the eventual outcome of this litigation and it could result in substantial costs, losses and a diversion of
management’s resources and attention, which could harm the Company’s business and the value of its common stock.
Product
and Professional Liability
Product
and professional liability litigation represents an inherent risk to all firms in the pharmaceutical and pharmacy industry. We utilize
traditional third-party insurance policies with regard to our product and professional liability claims. Such insurance coverage at any
given time reflects current market conditions, including cost and availability, when the policy is written.
John
Erick et al.
In
January 2018, John Erick and Deborah Ferrell, successors-in-interest and heirs of Jade Erick, (collectively “Erick”) filed
a lawsuit in the San Diego County Superior against Kim Kelly, ND, MPH asserting claims related to the death of Jade Erick. In April 2018,
Erick filed an amendment to the lawsuit, naming the Company as a co-defendant. In September 2018, co-defendant Dr. Kelly filed a cross-complaint
against the Company and various entities affiliated with Spectrum Laboratory Products, Inc., Spectrum Chemical Manufacturing Corp. and
Spectrum Pharmacy Products, Inc. (collectively “Spectrum”). The cross-complaint seeks indemnity and contribution from the
Company and Spectrum. The Company answered the claims filed by Dr. Kelly in October 2018. The case is currently in the discovery phase.
Trial is currently set to begin October 2021. Erick is seeking unspecified damages, interest, attorneys’ fees and other costs.
The Company believes the claims are meritless and has previously and will continue to dispute all claims asserted against it and intends
to vigorously defend against these allegations. The Company’s insurance carrier has reserved its rights to seek contribution from
the Company if the plaintiffs prevail on certain claims which the carrier alleges are uncovered. The Company believes the policy covers
all claims. Nonetheless, the Company cannot predict the eventual outcome of this litigation, it could result in substantial costs, losses
and a diversion of management’s resources and attention, which could harm the Company’s business and the value of its common
stock.
21
General
and Other
In
the ordinary course of business, the Company may face various claims brought by third parties and it may, from time to time, make claims
or take legal actions to assert its rights, including intellectual property disputes, contractual disputes and other commercial disputes.
Any of these claims could subject the Company to litigation.
Indemnities
In
addition to the indemnification provisions contained in the Company’s governing documents, the Company generally enters into separate
indemnification agreements with each of the Company’s directors and officers. These agreements require the Company, among other
things, to indemnify the director or officer against specified expenses and liabilities, such as attorneys’ fees, judgments, fines
and settlements, paid by the individual in connection with any action, suit or proceeding arising out of the individual’s status
or service as the Company’s director or officer, other than liabilities arising from willful misconduct or conduct that is knowingly
fraudulent or deliberately dishonest, and to advance expenses incurred by the individual in connection with any proceeding against the
individual with respect to which the individual may be entitled to indemnification by the Company. The Company also indemnifies its lessors
in connection with its facility leases for certain claims arising from the use of the facilities. These indemnities do not provide for
any limitation of the maximum potential future payments the Company could be obligated to make. Historically, the Company has not incurred
any payments for these obligations and, therefore, no liabilities have been recorded for these indemnities in the accompanying condensed
consolidated balance sheets.
Klarity
License Agreement – Related Party
The
Company entered into a license agreement in April 2017 and as amended in April 2018, (the “Klarity License Agreement”) with
Richard L. Lindstrom, M.D., a member of its Board of Directors. Pursuant to the terms of the Klarity License Agreement, the Company licensed
certain intellectual property and related rights from Dr. Lindstrom to develop, formulate, make, sell, and sub-license the topical ophthalmic
solution Klarity 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 $ 35 and $ 70 were made during the three and six months ended June 30,
2021, respectively. Payments totaling $ 0 and $ 55 were made during the three and six months ended June 30, 2020, respectively. Royalty
expense of $ 44 and $ 79 was incurred during the three and six months ended June 30, 2021, respectively, and $ 44 is included in accounts
payable to Dr. Lindstrom as of June 30, 2021. Royalty expense of $ 27 and $ 56 was incurred during the three and six months ended June
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 $ 14 in cash during the three and six months ended June 30, 2021, respectively. Dr. Lindstrom was paid $ 0 and $ 7 in cash during
the three and six months ended June 30, 2020, respectively. The Company incurred royalty expense of $ 7 and $ 14 and $ 4 and $ 42 related
to the Lindstrom APA during the three and six months ended June 30, 2021, and 2020, respectively.
22
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.
Subject
to early termination, the Dexycu Agreement expires on August 1, 2025, subject to specified
notice periods and specified limitations, either party may terminate the Dexycu Agreement
in the event of (i) uncured material breach by the other party or (ii) if 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 six months ended June 30,
2021, the Company recorded $ 827 and $ 1,312 , 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 $ 1,032 and $ 1,836 and $ 318 and $ 921 were incurred under these
agreements during the three and six months ended June 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 $ 261 and $ 493 and $ 117 and $ 261 were incurred under these agreements for the three and six months
ended June 30, 2021 and 2020, respectively, and $ 272 and $ 431 are included in accounts payable at June 30, 2021 and 2020, respectively.
23
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.
Mayfield
Pharmaceuticals MAY-44 APA Termination
In
May 2021, Mayfield and Harrow terminated their asset purchase agreement dated January 2020 for intellectual property rights associated
with Mayfield’s drug candidate MAY-44 with Elle Pharmaceutical LLC (the “MAY-44 APA”). 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.
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 pharmaceutical drug development business (Pharmaceutical Drug Development). Segment
contribution for the segments represents net revenues less cost of sales, research and development, selling and marketing expenses, and
select general and administrative expenses. The Company does not evaluate the following items at the segment level:
●
Selling,
general and administrative expenses that result from shared infrastructure, including certain expenses associated with legal matters,
public company costs (e.g. investor relations), board of directors and principal executive officers and other like shared expenses.
●
Operating
expenses within selling, general and administrative expenses that result from the impact of corporate initiatives. Corporate initiatives
primarily include integration, restructuring, acquisition and other shared costs.
●
Other
select revenues and operating expenses including R&D expenses, amortization, and asset sales and impairments, net as not all
such information has been accounted for at the segment level, or such information has not been used by all segments.
●
Total
assets including capital expenditures.
The
Company defines segment net revenues as pharmaceutical compounded drug sales, licenses, 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.
24
Segment
net revenues, segment operating expenses and segment contribution information consisted of the following for the three and six months
ended June 30, 2021:
SCHEDULE OF SEGMENT NET REVENUES, SEGMENT OPERATING EXPENSES AND SEGMENT CONTRIBUTION
For the
Three Months Ended
June 30, 2021
ImprimisRx
Pharmaceutical Drug Development
Total
Net revenues
$ 18,134
$ -
$ 18,134
Cost of sales
( 4,417 )
-
( 4,417 )
Gross profit
13,717
-
13,717
Operating expenses:
Selling, general and administrative
6,422
-
6,422
Research and development
112
104
216
Segment contribution
$ 7,183
$ ( 104 )
7,079
Corporate
2,662
Research and development
209
Amortization
39
Operating income
$ 4,169
For the
Six Months Ended
June 30, 2021
ImprimisRx
Pharmaceutical Drug Development
Total
Net revenues
$ 33,577
$ -
$ 33,577
Cost of sales
( 8,187 )
-
( 8,187 )
Gross profit
25,390
-
25,390
Operating expenses:
Selling, general and administrative
12,193
-
12,193
Research and development
322
117
439
Segment contribution
$ 12,875
$ ( 117 )
12,758
Corporate
5,015
Research and development
578
Amortization
79
Operating income
$ 7,086
For the
Three Months Ended
June 30, 2020
ImprimisRx
Pharmaceutical Drug Development
Total
Net revenues
$ 8,060
$ -
$ 8,060
Cost of sales
( 3,204 )
-
( 3,204 )
Gross profit
4,856
-
4,856
Operating expenses:
Selling, general and administrative
4,598
43
4,641
Research and development
497
46
543
Segment contribution
$ ( 239 )
$ ( 89 )
( 328 )
Corporate
2,270
Research and development
206
Amortization
43
Asset sales and impairments, net
363
Operating loss
$ ( 3,210 )
25
For the
Six Months Ended
June 30, 2020
Pharmaceutical
Pharmaceutical
Compounding
Drug Development
Total
Net revenues
$ 19,877
$ -
$ 19,877
Cost of sales
( 6,830 )
-
( 6,830 )
Gross profit
13,047
-
13,047
Operating expenses:
Selling, general and administrative
11,238
87
11,325
Research and development
540
57
597
Segment contribution
$ 1,269
$ ( 144 )
1,125
Corporate
3,957
Research and development
555
Amortization
88
Asset sales and impairments, net
363
Operating loss
$ ( 3,838 )
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 June 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 36 % of revenues during each of the three and six months ended June 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 six months ended June 30, 2021 and 2020.
The Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 85 %
and 79 % of active pharmaceutical ingredient purchases during the three and six months ended June 30, 2021, respectively, and 60 % and
70 % of active pharmaceutical ingredient purchases during the three and six months ended June 30, 2020, respectively.
NOTE
17. SUBSEQUENT EVENTS
The
Company has performed an evaluation of events occurring subsequent to June 30, 2021 through the filing date of this Quarterly Report.
Based on its evaluation, no events other than those described below need to be disclosed.
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 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.
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.
26
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited
condensed consolidated financial statements and the related notes thereto contained in Part I, Item 1 of this Quarterly Report on Form
10-Q (this “Quarterly Report”). Our condensed consolidated financial statements have been prepared and, unless otherwise
stated, the information derived therefrom as presented in this discussion and analysis is presented, in accordance with accounting principles
generally accepted in the United States of America (“GAAP”).
The
information contained in this Quarterly Report is not a complete description of our business or the risks associated with an investment
in our common stock. We urge you to carefully review and consider the various disclosures made by us in this Quarterly Report and in
our other reports filed with the U.S. Securities and Exchange Commission (the “SEC”), including our Annual Report on Form
10-K for the fiscal year ended December 31, 2020 and subsequent reports, which discuss our business in greater detail. As used in this
discussion and analysis, unless the context indicates otherwise, the terms the “Company,” “Harrow,” “we,”
“us” and “our” refer to Harrow Health, Inc. and its consolidated subsidiaries, consisting of Park Compounding,
Inc., ImprimisRx, LLC, ImprimisRx NJ, LLC dba ImprimisRx, Imprimis NJOF, LLC, Radley Pharmaceuticals, Inc., Mayfield Pharmaceuticals,
Inc., and Stowe Pharmaceuticals, Inc. In this discussion and analysis, we refer to our consolidated subsidiaries ImprimisRx, LLC, ImprimisRx
NJ, LLC and Imprimis NJOF, LLC collectively as “ImprimisRx.”
In
addition to historical information, the following discussion contains forward-looking statements regarding future events and our future
performance. In some cases, you can identify forward-looking statements by terminology such as “will,” “may,”
“should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,”
“predicts,” “forecasts,” “potential” or “continue” or the negative of these terms or
other comparable terminology. All statements made in this Quarterly Report other than statements of historical fact are forward-looking
statements. These forward-looking statements involve risks and uncertainties and reflect only our current views, expectations and assumptions
with respect to future events and our future performance. If risks or uncertainties materialize or assumptions prove incorrect, actual
results or events could differ materially from those expressed or implied by such forward-looking statements. Risks that could cause
actual results to differ from those expressed or implied by the forward-looking statements we make include, among others, risks related
to: the impact of the COVID-19 pandemic on our financial condition, liquidity or results of operations; our ability to successfully implement
our business plan, develop and commercialize our proprietary formulations in a timely manner or at all, identify and acquire additional
proprietary formulations, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit
and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions
and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities
and pharmacies; general economic and business conditions; regulatory and legal risks and uncertainties related to our pharmacy operations
and the pharmacy and pharmaceutical business in general; physician interest in and market acceptance of our current and any future formulations
and compounding pharmacies generally; our limited operating history; and the other risks and uncertainties described under the heading
“Risk Factors” in Part II, Item 1A of this Quarterly Report and in our other filings with the SEC. You should not place undue
reliance on forward-looking statements. Forward-looking statements speak only as of the date they are made and, except as required by
law, we undertake no obligation to revise or publicly update any forward-looking statement for any reason.
Overview
Our
business specializes in the development, production and sale of innovative medications that offer unique competitive advantages and serve
unmet needs in the marketplace through our subsidiaries and deconsolidated companies. We own and operate one of the nation’s leading
ophthalmology pharmaceutical businesses, ImprimisRx. In addition to wholly owning ImprimisRx, we also have 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”) and recently launched an online eye
health platform business in certain regions. We also own royalty rights in various drug candidates being developed by Surface and Melt.
27
ImprimisRx
ImprimisRx
is our ophthalmology focused prescription pharmaceutical business. We offer to over 10,000 physician customers and their patients critical
medicines to meet their needs that are unmet by commercially available drugs. We make our formulations available at prices that are,
in most cases, lower than non-customized commercial drugs. Our current ophthalmology formulary includes over twenty compounded formulations,
many of which are patented or patent-pending, and are customizable for the specific needs of a patient. Some examples of our compounded
medications are various combinations of drugs formulated into one bottle and numerous preservative free formulations. Depending on the
formulation, the regulations of a specific state and ultimately the needs of the patient, ImprimisRx products may be dispensed as patient-specific
medications from our 503A pharmacy, or for in-office use, made according to current good manufacturing practices (or cGMPs) or other
FDA-guidance documents, in our FDA-registered New Jersey outsourcing facility (“NJOF”).
On
August 1, 2020, ImprimisRx entered into a Commercial Alliance Agreement (the “Dexycu Agreement”) with Eyepoint Pharmaceuticals,
Inc. (“Eyepoint”), pursuant to which Eyepoint granted ImprimisRx 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 pays ImprimisRx
a fee that is calculated based on the quarterly sales of DEXCYU in excess of predefined volumes to specific customers of ImprimisRx
in the U.S.
AMP-100
Sintetica
has granted the Company the exclusive license and marketing rights to AMP-100 in the U.S. and Canada. AMP-100 is a patented, ophthalmic
topical anesthetic drug candidate. If FDA-approved, the active ingredient used in AMP-100 will be the first approved use of this active
ingredient in the U.S. ophthalmic market.
The
safety and efficacy of AMP-100 was demonstrated in various clinical trials including a Phase 2/3 randomized, double-masked, vehicle-controlled,
efficacy, safety and tolerability study in healthy volunteers and a non-inferiority Phase 3 study of 342 patients undergoing cataract
surgeries comparing AMP-100 to an active comparator. Ultimately, these studies demonstrated:
●
AMP-100
is safe, and the most common adverse event was mydrasis (dilation of pupil) in about 20% of patients which is an effect most ophthalmologists
may consider beneficial;
●
AMP-100
has rapid onset, and no inferiority to the active comparator (Phase 3);
●
Anesthesia
success of patients receiving AMP-100 was 95% vs. 20% with placebo (Phase 2/3 study);
●
Single
administration of AMP-100 provides roughly 20 minutes of sensory loss; and
●
AMP-100
has predictable offset (end of anesthesia) within a narrow bell curve (i.e. no wide variance).
We
expect a new drug application (“NDA”) for AMP-100 to be submitted by Sintetica to the FDA in the fourth quarter of 2021 and,
if approved, we plan to commercially launch AMP-100 in the fourth quarter of 2022.
If
approved, we expect our initial commercial focus of AMP-100 to be on ophthalmic procedures that traditionally require the eye to be anesthetized.
According to a 2019 MarketScope report, there are over four million cataract surgeries performed in the U.S. annually. In addition to
cataract procedures, according to Ophthalmologica, there were about 5.9 million intravitreal injections performed in the U.S. in 2018.
Most of these intravitreal injections, which are typically treatments for variety of conditions, including, age-related macular degeneration,
diabetic macular edema, and uveitis, often require the ocular surface to be anesthetized during the procedure.
AMP-100
is protected by one issued patent and another patent-pending. The issued patent includes composition of matter and method of use claims
and could provide protection for AMP-100 into 2037.
In
addition to AMP -100,
we expect to acquire and/or develop additional FDA-approved/approvable ophthalmic products and product candidates that will allow us
to leverage the commercial infrastructure of ImprimisRx to promote, sell, and ultimately bring these products to market.
Visionology
Visionology,
a direct-to-consumer online eye health platform, leverages our experience in the ophthalmic pharmaceutical business as well as our relationships
with eyecare professionals across the United States. We recently launched a proof-of-concept model for Visionology within a certain region
of the U.S., and if successful, will expand the launch on a nationwide basis later in 2021.
28
Pharmaceutical
Compounding Businesses
Pharmaceutical
Compounding
Pharmaceutical
compounding is the science of combining different active pharmaceutical ingredients (APIs), all of which are approved by the FDA (either
as a finished form product or as a bulk drug ingredient) and excipients, to create specialized pharmaceutical preparations. Physicians
and healthcare institutions use compounded drugs when commercially available drugs do not optimally treat a patient’s needs. In
many cases, compounded drugs, such as ours, have wide market utility and may be clinically appropriate for large patient populations.
Examples of compounded formulations include medications with alternative dosage strengths or unique dosage forms, such as topical creams
or gels, suspensions, or solutions with more tolerable drug delivery vehicles.
Almost
all of our sales revenue is derived from making, selling and dispensing our compounded prescription drug formulations as cash pay transactions
between us and our end-user customer. As such, the majority of our commercial transactions do not involve distributors, wholesalers,
insurance companies, pharmacy benefit managers or other middle parties. By not being reliant on insurance company formulary inclusion
and pharmacy benefit manager payment clawbacks, we are able to simplify the prescription transaction process. We believe the outcome
of our business model is a simple transaction, involving a patient-in-need, a physician’s diagnosis, a fair price and great service
for a quality pharmaceutical product. We sell our products through a network of employees and independent contractors and we dispense
our formulations in all 50 states, Puerto Rico and in selected markets outside the United States.
Our
Compounding Facilities
Pharmaceutical
compounding businesses are governed by Sections 503A and 503B of the Federal Food Drug and Cosmetic Act (the “FDCA”). Section
503A of the FDCA provides that a pharmacy is only permitted to compound a drug for an individually identified patient based on a prescription
for a patient, and is only permitted to distribute the drug interstate if the pharmacy is licensed to do so in the states where it is
compounded and where the medication is received.
Section
503B of the FDCA provides that a pharmacy engaged in preparing sterile compounded drug formulations may voluntarily elect to register
as an “outsourcing facility.” Outsourcing facilities are permitted to compound large quantities of drugs without a prescription
and distribute them out of state with certain limitations such as the formulation appearing on the FDA’s drug shortage list or
the bulk drug substances contained in the formulations appearing on the FDA’s “clinical need” list. Entities voluntarily
registering with FDA as outsourcing facilities are subject to additional requirements that do not apply to compounding pharmacies (operating
under Section 503A of the FDCA), including adhering to standards such as current good manufacturing practices (cGMP) or other FDA guidance
documents and being subject to regular FDA inspection.
We
operate two compounding facilities located in Ledgewood, New Jersey. Our New Jersey operations are comprised of two separate entities
and facilities, one of which is registered with the FDA as an outsourcing facility (“NJOF”) under Section 503B of the FDCA.
The other New Jersey facility (“RxNJ”), is a licensed pharmacy operating under Section 503A of the FDCA. All products that
we sell, produce and dispense are made in the United States.
We
believe that, with our current compounding pharmacy facilities and licenses and FDA registration of NJOF, we have the infrastructure
to scale our business appropriately under the current regulatory landscape and meet the potential growth in demand we are targeting.
We plan to invest in one or both of our facilities to further their capacity and efficiencies. Also, we may seek to access greater pharmacy
and production related redundancy and markets through acquisitions, partnerships or other strategic transactions.
Pharmaceutical
Development Carve-Out Businesses
We
have ownership interests in Eton Pharmaceuticals, Inc. (“Eton”), Surface and Melt and hold royalty interests in some of the
drug candidates of Surface and Melt. These companies are pursuing market approval for their drug candidates under the FDCA, including
in some instances under the abbreviated pathway described in Section 505(b)(2) which permits the submission of a new drug application
(“NDA”) where at least some of the information required for approval comes from studies not conducted by or for the applicant
and for which the applicant has not obtained a right of reference.
In
2018 and 2019, we formed and created subsidiaries named Radley Pharmaceuticals, Inc. (“Radley”), Mayfield Pharmaceuticals,
Inc. (“Mayfield”), and Stowe Pharmaceuticals, Inc. (“Stowe”). In 2020, we halted nearly all operating activities
related to these subsidiaries to invest resources in other areas and may not restart any or all activities related to these businesses.
In addition, we terminated license and acquisition agreements for Mayfield’s MAY-66 and MAY-44 drug candidates, and Stowe’s
STE-006 drug candidate.
29
De-Consolidated
Businesses (Noncontrolling Equity Interests)
Surface
Ophthalmics, Inc.
Surface
is a clinical-stage pharmaceutical company focused on development and commercialization of innovative therapeutics for ocular surface
diseases.
In
January 2021, Surface announced positive top-line results from a phase 2 trial of its drug candidate SURF-201, a 0.2% betamethasone,
preservative-free ophthalmic solution in the Klarity delivery vehicle for the treatment of post cataract surgery pain and inflammation.
According to the Surface results, SURF-201 was dosed twice daily, met its primary endpoints of absence of inflammation at both Day 8
and Day 15 and was found to be safe and well-tolerated by the patient group. In addition, a secondary endpoint showed almost 90% of patients
given SURF-201 were pain free at Day 15. SURF-201 marks the first ophthalmic therapeutic in the United States to utilize betamethasone
as well as being the first preservative-free unit dose therapy for the treatment of post-operative pain and inflammation.
Also
in January 2021, Surface announced the first patient dosed in a head-to-head phase 2 trial for its drug candidate SURF-100 (mycophenolate
sodium and betamethasone in Klarity vehicle) for the treatment of chronic dry eye disease. The head-to-head study will compare SURF-100
against leading on-market competitors lifitegrast ophthalmic solution 5% (marketed as Xiidra®) and cyclosporine ophthalmic emulsion
0.05% (marketed as Restasis®).
In
February 2021, Surface announced the first patient dosed in a phase 2 trial for its drug candidate SURF-200 (betamethasone in Klarity
vehicle) for the treatment of episodic dry eye flares. The dose ranging study for SURF-200 will be administered in two different low
concentration formulations of betamethasone in the Klarity vehicle. The trial will enroll 120 to 140 patients with a primary endpoint
of Symptom Improvement of one unit based on the University of North Carolina Dry Eye Management Scale by the eighth day.
In
2018, Surface closed an offering of its Series A Preferred Stock. At that time, we lost our controlling interest and deconsolidated Surface
from our consolidated financial statements. During May, June and July of 2021, Surface closed an offering of its preferred stock at a
purchase price of $4.50 per share resulting in gross proceeds to Surface of approximately $25,000,000 (the “Surface Series B Offering”).
We own 3,500,000 shares of Surface common stock which was approximately 20% of the equity and voting interests following the final close
of the Surface Series B Offering. Harrow owns mid-single digit royalty rights on net sales of SURF-100, SURF-200 and SURF-201.
Melt
Pharmaceuticals, Inc.
Melt
is a clinical-stage pharmaceutical company focused on the development and commercialization of proprietary non-intravenous, sedation
and anesthesia therapeutics for human medical procedures in hospital, outpatient, and in-office settings. Melt intends to seek regulatory
approval for its proprietary technologies, where possible. In December 2018, we entered into an Asset Purchase Agreement with Melt (the
“Melt Asset Purchase Agreement”), and Harrow assigned to Melt the underlying intellectual property for Melt’s current
pipeline, including its lead drug candidate MELT-100. The core intellectual property Melt owns is a patented series of combination non-opioid
sedation drug formulations that we estimate to have multitudinous applications.
MELT-100
is a novel, sublingually delivered, non-IV, opioid-free drug candidate being developed for procedural sedation. Melt filed an investigational
new drug application (“IND”) with the FDA in June 2020 and began its clinical program for MELT-100. In February 2021, Melt
announced data from, and the successful completion of, its phase 1 study. Melt expects to begin its phase 2 study for MELT-100 in the
second half of 2021.
In
January 2019, Melt closed an offering of its Series A Preferred Stock. At that time, we lost our controlling interest and deconsolidated
Melt from our consolidated financial statements. We own 3,500,000 shares of Melt common stock, which was approximately 44% of the equity
and voting interests issued and outstanding of as of June 30, 2021. We expect Melt to complete another round of financing within the
next six months. Pursuant to 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 MELT-100, while any patent rights remain outstanding, subject to other conditions. Melt can require the
Company to cease compounding like products at the time of FDA approval of MELT-100. If approved, we do not expect a cessation of compounding
like products to have a material impact on our operations and financial performance.
30
Eton
Pharmaceuticals, Inc.
Eton
is a commercial-stage pharmaceutical company focused on developing and commercializing innovative drug products. Its pipeline includes
several products and drug candidates in various stages of development across a variety of dosage forms. In May 2017, Eton closed an offering
of its Series A Preferred Stock and we lost our controlling interest in it. In November 2018, Eton completed an initial public offering
of its common stock. At that time, we gave up our controlling interest and deconsolidated Eton from our consolidated financial statements.
As of the date of this Quarterly Report and following our April 2021 sale, we own 1,982,000 shares of Eton common stock. We owned less
than 10% of the equity and voting interests issued and outstanding of Eton as of June 30, 2021.
Factors
Affecting Our Performance
We
believe the primary factors affecting our performance are our ability to increase revenues of our proprietary compounded formulations
and certain non-proprietary products, grow and gain operating efficiencies in our pharmacy operations, potential regulatory-related restrictions,
optimize pricing and obtain reimbursement options for our proprietary compounded formulations, and continue to pursue development and
commercialization opportunities for certain of our ophthalmology and other assets that we have not yet made commercially available as
compounded formulations. We believe we have built a tangible and intangible infrastructure that will allow us to scale revenues efficiently
in the near and long-term. All of these activities will require significant costs and other resources, which we may not have or be able
to obtain from operations or other sources. See “Liquidity and Capital Resources” below.
Reimbursement
Options
Our
proprietary ophthalmic compounded formulations are currently primarily available on a cash-pay basis. However, we work with third-party
insurers, pharmacy benefit managers and buying groups to offer patient-specific customizable compounded formulations at accessible prices.
We may devote time and other resources to seek reimbursement and patient pay opportunities for these and other compounded formulations
and we have hired pharmacy billers to process certain existing reimbursement opportunities for certain formulations. However, we may
be unsuccessful in achieving these goals, as many third-party payors have imposed significant restrictions on reimbursement for compounded
formulations in recent years. Moreover, third-party payors, including Medicare, are increasingly attempting to contain health care costs
by limiting coverage and the level of reimbursement for new drugs and by refusing, in some cases, to provide coverage for uses of approved
products for disease indications for which the FDA has not granted labeling approval. Further, the Patient Protection and Affordable
Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (collectively, the “Health Care
Reform Law”), may have a considerable impact on the existing U.S. system for the delivery and financing of health care and could
conceivable have a material effect on our business. As a result, reimbursement from Medicare, Medicaid and other third-party payors may
never be available for any of our products or, if available, may not be sufficient to allow us to sell the products on a competitive
basis and at desirable price points. We are communicating with government and third-party payors in order to make our formulations available
to more patients and at optimized pricing levels. However, if government and other third-party payors do not provide adequate coverage
and reimbursement levels for our formulations, the market acceptance and opportunity for our formulations may be limited.
COVID-19
Pandemic
A
novel strain of coronavirus was first identified in Wuhan, China in December 2019. The disease caused by it, COVID-19, was declared a
global pandemic by the World Health Organization in March 2020. On March 18, 2020, CMS released guidance for U.S. healthcare providers
to limit all elective medical procedures in order to conserve personal protective equipment and limit exposure to COVID-19 during the
pendency of the pandemic. In addition to limiting elective medical procedures, many hospitals and other healthcare providers have strictly
limited access to their facilities during the pandemic. The COVID-19 pandemic has negatively impacted the global economy, disrupted global
supply chains and healthcare delivery, led to social distancing recommendation, and created significant volatility in financial markets.
In May 2020 and the following months, U.S. states and geographies began easing restrictions associated with the COVID-19 pandemic including
those restrictions related to elective procedures. We have since seen sales of our products return to near historical norms and trends
as restrictions associated with elective procedures and the COVID-19 pandemic have continued to ease.
However,
given the unprecedented and dynamic nature of the COVID-19 pandemic virus, including any mutations/variants, we may not be able to reasonably
estimate the impacts it may have on our financial condition, results of operations or cash flows in the future, especially if there are
new restrictions in elective procedures in the future which would have an adverse impact, which may be material, on our future revenues,
profitability and cash flows.
31
Recent
Developments
The
following describes certain developments in 2021 to date that are important to understand our financial condition and results of operations.
See the notes to our condensed consolidated financial statements included in this report for additional information about each of these
developments.
PPP
Loan
In
April 2020, we 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 $1,967,000 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. 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 and accordingly recognized a gain on forgiveness of debt of $1,967,000.
Eton
Stock Sale
In
April 2021, we closed an underwritten public offering of 1,518,000 shares of our Eton common stock at a public offering price of $7.00
per share (the “Eton Stock Sale”). The gross proceeds to us from the Eton Stock Sale were $10,626,000 before deducting underwriting
discounts and commissions and other offering expenses payable by the Company. Following such sale, we own 1,982,000 shares of Eton common
stock, which represented less than 10% of the equity interests issued and outstanding of Eton as of June 30, 2021.
As
part of the Eton Stock Sale, we also 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).
8.625%
Senior Notes Due 2026
During
April, May and June 2021, we closed offerings totaling $75,000,000 aggregate principal amount of 8.625% senior notes due 2026 (the “Notes”).
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 our 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 the
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.
Prior
to February 1, 2026, we may, at our 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. We 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.
Series
B Cumulative Preferred Stock
On
May 5, 2021, we sold 440,000 shares of Series B Cumulative Preferred Stock (the “Series B Preferred Stock”) for net
proceeds of $10,670,000. On June 17, 2021, the Company redeemed all of the outstanding shares of the Series B Preferred Stock. The
redemption price for the 440,000 shares of the Series B Preferred Stock outstanding was equal to $25.00 per share, plus accrued and unpaid
dividends, which in aggregate totaled $11,127,000.
32
Sintetica
Agreement
In
July 2021, we 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 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.
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.
Results
of Operations
The
following period-to-period comparisons of our financial results for the three and six months ended June 30, 2021 and 2020, are not necessarily
indicative of results for the current period or any future period.
Revenues
Our
revenues include amounts recorded from sales of proprietary compounded formulations, commissions from third parties and revenues received
from royalty payments owed to us pursuant to out-license arrangements.
The
following presents our revenues for the three and six months ended June 30, 2021 and 2020:
For the
Three Months Ended
For the
Six Months Ended
June 30,
June 30,
$
2021
2020
Variance
2021
2020
Variance
Product sales, net
$ 17,297
$ 8,049
$ 9,248
$ 32,245
$ 19,859
$ 12,386
Commission revenues
827
-
827
1,312
-
1,312
License revenues
10
11
(1 )
20
18
2
Total revenues
$ 18,134
$ 8,060
$ 10,074
$ 33,577
$ 19,877
$ 13,700
The
increase in revenues between periods was related to an increase in sales volumes of our ophthalmology products and commissions attributable
to sales of Dexycu®.
Cost
of Sales
Our
cost of sales 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.
The
following presents our cost of sales for the three and six months ended June 30, 2021 and 2020:
For the
Three Months Ended
For the
Six Months Ended
June 30,
$
June 30,
$
2021
2020
Variance
2021
2020
Variance
Cost of sales
$ 4,417
$ 3,204
$ 1,213
$ 8,187
$ 6,830
$ 1,357
The
increase in our cost of sales between periods was largely attributable to an increase in unit volumes sold.
33
Gross
Profit and Margin
For the
Three Months Ended
For the
Six Months Ended
June 30,
$
June 30,
$
2021
2020
Variance
2021
2020
Variance
Gross profit
$ 13,717
$ 4,856
$ 8,861
$ 25,390
$ 13,047
$ 12,343
Gross margin
75.6 %
60.2 %
15.4 %
75.6 %
65.6 %
10.0 %
The
increase in gross margin between periods is largely attributable to increased unit volumes sold, efficiencies in our production process,
including increased batch sizes, and improved utilization of capacities as a result of increased output.
Selling,
General and Administrative Expenses
Our
selling, general and administrative expenses include personnel costs, including wages and stock-based compensation, corporate facility
expenses, and investor relations, consulting, insurance, filing, legal and accounting fees and expenses as well as costs associated with
our marketing activities and sales of our proprietary compounded formulations and other non-proprietary pharmacy products and formulations.
The
following presents our selling, general and administrative expenses for the three and six months ended June 30, 2021 and 2020:
For the
Three Months Ended
For the
Six Months Ended
June 30,
$
June 30,
$
2021
2020
Variance
2021
2020
Variance
Selling, general and administrative
$ 9,123
$ 6,954
$ 2,169
$ 17,287
$ 15,370
$ 1,917
The
increase in selling, general and administrative expenses between periods was primarily attributable to an increase in commissions and
other expenses related to increased sales, and as well as an increase in our sales and marketing expenses related to in-person conferences
and new employee costs to support sales growth.
Research
and Development Expenses
Our
research and development expenses primarily include personnel costs, including wages and stock-based compensation, expenses related to
the development of intellectual property, investigator-initiated research and evaluations, formulation development, and other costs related
to the clinical development of our assets.
The
following presents our research and development expenses for the three and six months ended June 30, 2021 and 2020:
For the
Three Months Ended
For the
Six Months Ended
June 30,
$
June 30,
$
2021
2020
Variance
2021
2020
Variance
Research and development
$ 425
$ 749
$ (324 )
$ 1,017
$ 1,152
$ (135 )
Research
and development expenses between periods was primarily attributable to formulation development studies for new ophthalmic formulations
and clinical programs related to our drug development segment during the three and six months ended June 30, 2021.
Interest
Expense, net
Interest
expense, net was $1,314,000 and $1,827,000 for the three and six months ended June 30, 2021, respectively, compared to $505,000 and $1,065,000
for the same periods last year, respectively. The increase during the period ended June 30, 2021 compared to the same period in 2020
was primarily due to an increase in the outstanding principal amount of our debt obligations.
34
Investment
Loss from Melt
During
the three and six months ended June 30, 2021, we recorded a net loss of $477,000 and $947,000, respectively, related to our share of
losses in Melt. During the three and six months ended June 30, 2020, we recorded a loss of $690,000 and $1,236,000, respectively, for
our share of losses based on our ownership of Melt.
Investment
Loss from Surface
During
the three and six months ended June 30, 2021, we recorded a loss of $465,000 and $1,314,000, respectively, for our share of losses based
on our ownership of Surface. During the three and six months ended June 30, 2020, we recorded a loss of $599,000 and $938,000, respectively,
for our share of losses based on our ownership of Surface.
Investment
Loss from Eton
We
recorded a loss of $3,584 ,000 and $6,419,000 related to the change in fair market value of Eton’s common stock and the sale of
a portion of our Eton stock during the three and six months ended June 30, 2021, respectively. We recorded a gain of $4,725,000 and loss
of $6,125 related to the change in fair market value of Eton’s common stock during the three and six months ended June 30, 2020,
respectively.
Loss
From Early Extinguishment of Loan
During
the three and six months ended June 30, 2021, we recorded a loss from the early extinguishment of loan of $756,000 related to the early
payoff of the SWK Loan.
Gain
on Forgiveness of PPP Loan
During
the six months ended June 30, 2021, we recorded gain on forgiveness of PPP loan of $1,967,000 related to the forgiveness of our PPP Loan.
Net
loss
The
following table presents our net loss and per share net loss for the three and six months ended June 30, 2021 and 2020:
For the
Three Months Ended
For the
Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Numerator – net loss attributable to Harrow Health, Inc. common stockholders
$ (2,950,000 )
$ (237,000 )
$ (2,733,000 )
$ (13,144,000 )
Net loss per share, basic and diluted
$ (0.11 )
$ (0.01 )
$ (0.10 )
$ (0.51 )
Financial
Information About Segments and Geographic Areas
Management
evaluates performance of the Company based on operating segments. Segment performance for our two operating segments are based on segment
contribution. Our reportable segments consist of (i) our commercial stage pharmaceutical business ImprimisRx; and (ii) the start-up operations
associated with our 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. We do not evaluate the following items at the segment level:
●
Selling,
general and administrative expenses that result from shared infrastructure, including certain expenses associated with litigation
and other 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.
35
●
Other
select revenues and operating expenses including R&D expenses, amortization, and asset sales and impairments, net as not all
such information has been accounted for at the segment level, or such information has not been used by all segments.
●
Total
assets including capital expenditures.
The
Company defines segment net revenues as pharmaceutical compounded drug sales, licenses and other revenue derived from related agreements.
Cost
of sales within segment contribution includes direct and indirect costs to manufacture formulations and sell products, including active
pharmaceutical ingredients, personnel costs, packaging, storage, royalties, shipping and handling costs, manufacturing equipment and
tenant improvements depreciation, the write-off of obsolete inventory and other related expenses.
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.
See
Note 16 to our condensed consolidated financial statements included in this Quarterly Report for more information about our reportable
segments.
Liquidity
and Capital Resources
Liquidity
Our
cash on hand (including restricted cash) at June 30, 2021 was $72,851,000, compared to $4,301,000 at December 31, 2020.
As
of the date of this Quarterly Report, we believe that cash and cash equivalents of $72,651,000 and restricted cash of $200,000, totaling
approximately $72,851,000 at June 30, 2021, will be sufficient to sustain our planned level of operations and capital expenditures for
at least the next 12 months. In addition, we may consider the sale of certain assets including, but not limited to, part of, or all of,
our ownership interest in Eton, Surface, Melt, and/or any of our consolidated subsidiaries. However, we may pursue acquisitions of pharmacies,
revenue generating products, drug candidates or other strategic transactions that involve large expenditures or we may experience growth
more quickly or on a larger scale than we expect, any of which could result in the depletion of capital resources more rapidly than anticipated
and could require us to seek additional financing to support our operations.
We
expect to use our current cash position and funds generated from our operations and any financing to pursue our business plan, which
includes developing and commercializing drug candidates, compounded formulations and technologies, integrating and developing our operations,
pursuing potential future strategic transactions as opportunities arise, including potential acquisitions of additional pharmacy, outsourcing
facilities, drug company and manufacturers, drug products, drug candidates, and/or assets or technologies, and otherwise fund our operations.
We may also use our resources to conduct clinical trials or other studies in support of our formulations or any drug candidate for which
we pursue FDA approval, to pursue additional development programs or to explore other development opportunities.
Net
Cash Flow
The
following provides detailed information about our net cash flows:
For the
Six Months Ended
June 30,
2021
2020
Net cash provided by (used in):
Operating activities
$ 8,648,000
$ (3,201,000 )
Investing activities
8,445,000
(610,000 )
Financing activities
51,457,000
2,964,000
Net change in cash and cash equivalents
68,550,000
(847,000 )
Cash, cash equivalents and restricted cash at beginning of the period
4,301,000
4,949,000
Cash, cash equivalents and restricted cash at end of the period
$ 72,851,000
$ 4,102,000
36
Operating
Activities
Net
cash provided by operating activities during the six months ended June 30, 2021 was $8,648,000 compared to net cash used in operating
activities of $3,201,000 during the same period in the prior year. The increase in net cash provided by operating activities during the
periods was mainly attributed to the increase in revenues.
Investing
Activities
Net
cash provided by investing activities during the six months ended June 30, 2021 was $8,445,000 compared to net cash used in investing
activities of $610,000, respectively. Cash provided by investing activities in 2021 was primarily associated with the sale of a portion
of our investment in Eton. Cash used in investing activities in 2020 was primarily associated with equipment and software purchases and
upgrades along with investments in our intellectual property portfolio.
Financing
Activities
Net
cash provided by financing activities during the six months ended June 30, 2021 was $51,457,000 and $2,964,000, respectively. Cash provided
by financing activities during the six months ended June 30, 2021 was primarily related to proceeds received from the sale of Notes,
net of the payment of all outstanding obligations to the Company’s previous senior lender, SWK Funding, LLC and its partners.
Sources
of Capital
Our
principal sources of cash consist of cash provided by operating activities from our ImprimisRx business, and recently, proceeds from
the sale of the Notes and sale of Eton Stock. We may also sell some or all of our ownership interests in Surface, Melt or our other subsidiaries,
along with the some or all of the remaining portion of our Eton common stock.
The
changing trends and overall economic outlook in light of the COVID-19 pandemic, including the historic interim stay-at-home orders and
bans on elective surgeries, created uncertainty surrounding our operating outlook and may impact our future operating results if there
is a rise in COVID-19 related cases in the U.S. In addition, we may acquire new products, product candidates and/or businesses, as a
result, we may need significant additional capital to support our business plan and fund our proposed business operations. We may receive
additional proceeds from the exercise of stock purchase warrants that are currently outstanding. We may also seek additional financing
from a variety of sources, including other equity or debt financings, funding from corporate partnerships or licensing arrangements,
sales of assets or any other financing transaction. If we issue equity or convertible debt securities to raise additional funds, our
existing stockholders may experience substantial dilution, and the newly issued equity or debt securities may have more favorable terms
or rights, preferences and privileges senior to those of our existing stockholders. If we raise additional funds through collaboration
or licensing arrangements or sales of assets, we may be required to relinquish potentially valuable rights to our product candidates
or proprietary technologies or formulations, or grant licenses on terms that are not favorable to us. If we raise funds by incurring
additional debt, we may be required to pay significant interest expenses and our leverage relative to our earnings or to our equity capitalization
may increase. Obtaining commercial loans, assuming they would be available, would increase our liabilities and future cash commitments
and may impose restrictions on our activities, such as the financial and operating covenants. Further, we may incur substantial costs
in pursuing future capital and/or financing transactions, including investment banking fees, legal fees, accounting fees, printing and
distribution expenses and other costs. We may also be required to recognize non-cash expenses in connection with certain securities we
may issue, such as convertible notes and warrants, which would adversely impact our financial results.
We
may be unable to obtain financing when necessary as a result of, among other things, our performance, general economic conditions, conditions
in the pharmaceuticals and pharmacy industries, or our operating history, including our past bankruptcy proceedings. In addition, the
fact that we have a limited history of profitability could further impact the availability or cost to us of future financings. As a result,
sufficient funds may not be available when needed from any source or, if available, such funds may not be available on terms that are
acceptable to us. If we are unable to raise funds to satisfy our capital needs when needed, then we may need to forego pursuit of potentially
valuable development or acquisition opportunities, we may not be able to continue to operate our business pursuant to our business plan,
which would require us to modify our operations to reduce spending to a sustainable level by, among other things, delaying, scaling back
or eliminating some or all of our ongoing or planned investments in corporate infrastructure, business development, sales and marketing
and other activities, or we may be forced to discontinue our operations entirely.
37
Recently
Issued and Adopted Accounting Pronouncements
See
Note 2 to our condensed consolidated financial statements included in this Quarterly Report.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
Not
applicable.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed
or submitted pursuant to the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized
and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated
to our management, including our principal executive officer and principal financial officer, as appropriate, to allow for timely decisions
regarding required disclosure.
Under
the supervision and with the participation of our principal executive officer and principal financial officer, our management conducted
an evaluation of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) promulgated under the Exchange
Act, as they existed on June 30, 2021. Based on this evaluation, our principal executive officer and principal financial officer have
concluded that our disclosure controls and procedures were effective to achieve their stated purpose as of June 30, 2021, the end of
the period covered by this report.
Changes
in Internal Controls over Financial Reporting
There
has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during the
quarter ended June 30, 2021, that has materially affected, or is reasonably likely to materially affect, our internal control over financial
reporting. We have not experienced any material impact to our internal control over financial reporting due to the COVID-19 pandemic.
We are continually monitoring and assessing the COVID-19 pandemic on our internal controls to minimize the impact on their design and
operating effectiveness.
38
PART
II
OTHER
INFORMATION
Item
1. Legal Proceedings
See
Note 15 to our condensed consolidated financial statements included in this Quarterly Report for information on various legal proceedings,
which is incorporated into this Item by reference.
Item
1A. Risk Factors
You
should carefully consider the following risk factors in addition to the other information contained in this Quarterly Report. Our business,
financial condition, results of operations and stock price could be materially adversely affected by any of these risks. You should consider
all of the factors described in this section when evaluating our business as well as the risk factors and the other information in our
Quarterly Report on Form 10-Q for the three months ended March 31, 2021 and in our Annual Report on Form 10-K for the year ended December
31, 2020, including our audited financial statements and the related notes and “Management’s Discussion and Analysis of Financial
Condition and Results of Operations.” If any of the following risks actually occurs, our business, financial condition, results
of operations and future growth prospects would likely be materially and adversely affected. In these circumstances, the market price
of our common stock would likely decline and you may lose all or part of your investments. Additional risks and uncertainties not presently
known to us or that we currently deem immaterial also may impair our business operations.
Risks
Related to the Senior Notes
We
have incurred significant indebtedness, which will require substantial cash to service and which subjects us to certain financial requirements
and business restrictions.
In
April, May and June 2021, we issued $75,000,000 aggregate principal amount of 8.625% senior notes due 2026 (the “Notes”).
We may incur additional indebtedness in the future. Our ability to make scheduled payments on our indebtedness depends on our future
performance and ability to raise additional capital, which is subject to economic, financial, competitive and other factors, some of
which are beyond our control. If we are unable to generate sufficient cash to service our debt, we may be required to adopt one or more
alternatives, such as selling assets, restructuring our debt or obtaining additional capital through equity sales or incurrence of additional
debt on terms that may be onerous or highly dilutive to our stockholders. Our ability to engage in any of these activities would depend
on the capital markets and our financial condition at such time, and we may not be able to do so when needed, on desirable terms or at
all, which could result in a default on our debt obligations. Additionally, our debt instruments contain or, from time to time, may contain
various restrictive covenants, including, among others, our obligation to deliver certain financial and other information, our obligation
to comply with certain notice and insurance requirements, and our inability, without prior consent, to dispose of certain of our assets,
incur certain additional indebtedness, enter into certain merger, acquisition or change of control transactions, pay certain dividends
or distributions on or repurchase any of our capital stock or incur any lien or other encumbrance on our assets, subject to certain permitted
exceptions. Any failure by us to comply with any of these covenants, subject to certain cure periods, or to make all payments under the
debt instruments when due, would cause us to be in default under the applicable debt instrument. In the event of any such default, lenders
may be able to foreclose on our assets that secure the debt or declare all borrowed funds, together with accrued and unpaid interest,
immediately due and payable, thereby potentially causing all of our available cash to be used to pay our indebtedness or forcing us into
bankruptcy or liquidation if we do not then have sufficient cash available. Any such event or occurrence could severely and negatively
impact our operations and prospects.
We
may need additional capital in order to continue operating our business, and such additional funds may not be available when needed,
on acceptable terms, or at all.
We
only recently started generating cash from operations, but we do not currently earn sufficient revenues to support our operations. We
may need significant additional capital to execute our business plan and fund our proposed business operations. Additionally, our plans
may change or the estimates of our operating expenses and working capital requirements could be inaccurate, we may pursue acquisitions
of pharmacies or other strategic transactions that involve large expenditures, or we may experience growth more quickly or on a larger
scale than we expect, any of which may result in the depletion of capital resources more rapidly than anticipated and could require us
to seek additional financing earlier than we expect to support our operations.
39
We
have raised over $85,000,000 in funds through equity and debt financings in April, May and June 2021. We may seek to obtain additional
capital through equity or debt financings, funding from corporate partnerships or licensing arrangements, sales of assets or other financing
transactions. If we issue additional equity or debt securities to raise funds, our existing stockholders may experience substantial dilution,
and the newly issued equity or debt securities may have more favorable terms or rights, preferences and privileges senior to those of
our existing stockholders. If we raise additional funds through collaboration and licensing arrangements or sales of assets, we may have
to relinquish potentially valuable rights to our drug candidates or proprietary technologies, or grant licenses on terms that are not
favorable to us. If we raise funds by incurring additional debt, we may be required to pay significant interest expenses and our leverage
relative to our earnings or to our equity capitalization may increase. Obtaining commercial loans, assuming those loans would be available,
would increase our liabilities and future cash commitments and may impose restrictions on our activities. Further, we may incur substantial
costs in pursuing future capital and/or financing transactions, including investment banking fees, legal fees, accounting fees, printing
and distribution expenses and other costs. We may also be required to recognize non-cash expenses in connection with certain securities
we may issue, such as options, convertible notes and warrants, which would adversely impact our financial results.
The
Notes are unsecured and therefore are effectively subordinated to any secured indebtedness that we currently have or that we may incur
in the future.
The
Notes are not secured by any of our assets or any of the assets of our subsidiaries. As a result, the Notes are effectively subordinated
to any secured indebtedness that we or our subsidiaries have currently outstanding or may incur in the future (or any indebtedness that
is initially unsecured to which we subsequently grant security) to the extent of the value of the assets securing such indebtedness.
The indenture governing the Notes does not prohibit us or our subsidiaries from incurring additional secured (or unsecured) indebtedness
in the future. In any liquidation, dissolution, bankruptcy or other similar proceeding, the holders of any of our existing or future
secured indebtedness and the secured indebtedness of our subsidiaries may assert rights against the assets pledged to secure that indebtedness
and may consequently receive payment from these assets before they may be used to pay other creditors, including the holders of the Notes.
The
indenture under which the Notes were issued contains limited protection for holders of the Notes.
The
indenture under which the Notes were issued offers limited protection to holders of the Notes. The terms of the indenture and the Notes
do not restrict our or any of our subsidiaries’ ability to engage in, or otherwise be a party to, a variety of corporate transactions,
circumstances or events that could have an adverse impact on the holders of the Notes. In particular, the terms of the indenture and
the Notes do not place any restrictions on our or our subsidiaries’ ability to:
●
issue
debt securities or otherwise incur additional indebtedness or other obligations, including (1) any indebtedness or other obligations
that would be equal in right of payment to the Notes, (2) any indebtedness or other obligations that would be secured and therefore
rank effectively senior in right of payment to the Notes to the extent of the values of the assets securing such debt, (3) indebtedness
of ours that is guaranteed by one or more of our subsidiaries and which therefore is structurally senior to the Notes and (4) securities,
indebtedness or obligations issued or incurred by our subsidiaries that would be senior to our equity interests in our subsidiaries
and therefore rank structurally senior to the Notes with respect to the assets of our subsidiaries;
●
pay
dividends on, or purchase or redeem or make any payments in respect of, capital stock or other securities subordinated in right of
payment to the Notes;
●
sell
assets (other than certain limited restrictions on our ability to consolidate, merge or sell all or substantially all of our assets);
●
enter
into transactions with affiliates;
●
create
liens (including liens on the shares of our subsidiaries) or enter into sale and leaseback transactions;
●
make
investments; or
●
create
restrictions on the payment of dividends or other amounts to us from our subsidiaries.
40
In
addition, the indenture does not include any protection against certain events, such as a change of control, leveraged recapitalization,
“going private” transaction (which may result in a significant increase of our indebtedness), restructuring or similar transactions.
Furthermore, the terms of the indenture and the Notes do not protect holders of the Notes in the event that we experience changes (including
significant adverse changes) in our financial condition, results of operations or credit ratings, as they do not require that we or our
subsidiaries adhere to any financial tests or ratios or specified levels of net worth, revenues, income, cash flow, or liquidity. Also,
an event of default or acceleration under our other indebtedness would not necessarily result in an event of default under the Notes.
Our
ability to recapitalize, incur additional debt and take a number of other actions that are not limited by the terms of the Notes may
have important consequences for the holders of the Notes, including making it more difficult for us to satisfy our obligations with respect
to the Notes or negatively affecting the trading value of the Notes.
Other
debt we issue or incur in the future could contain more protections for its holders than the indenture and the Notes, including additional
covenants and events of default. The issuance or incurrence of any such debt with incremental protections could affect the market for
and trading levels and prices of the Notes.
An
increase in market interest rates could result in a decrease in the value of the Notes.
In
general, as market interest rates rise, notes bearing interest at a fixed rate decline in value. Consequently, if the market interest
rates increase, the market value of the Notes may decline. We cannot predict the future level of market interest rates.
An
active trading market for the Notes may not develop, which could adversely affect the market price of the Notes or limit a holder’s
ability to sell them.
The
Notes are quoted on Nasdaq under the symbol “HROWL.” We cannot provide any assurances that an active trading market will
develop for the Notes or that a holder will be able to sell the Notes. If the Notes are traded, they may trade at a discount from their
initial offering price depending on prevailing interest rates, the market for similar securities, our credit ratings, general economic
conditions, our financial condition, performance and prospects and other factors. The underwriters of the Notes may make a market in
the Notes, but they are not obligated to do so. The underwriters may discontinue any market-making in the Notes at any time at their
sole discretion. Accordingly, we cannot assure a holder that a liquid trading market will develop for the Notes, that a holder will be
able to sell the Notes at a particular time or that the price received will be favorable. To the extent an active trading market does
not develop, the liquidity and trading price for the Notes may be harmed. Accordingly, a holder may be required to bear the financial
risk of an investment in the Notes for an indefinite period of time.
We
may issue additional notes.
Under
the terms of the indenture governing the Notes, we may from time to time without notice to, or the consent of, the holders of the Notes,
create and issue additional notes which will be equal in rank to the Notes.
The
rating for the Notes could at any time be revised downward or withdrawn entirely at the discretion of the issuing rating agency.
We
have obtained a rating for the Notes. Ratings only reflect the views of the issuing rating agency or agencies and such ratings could
at any time be revised downward or withdrawn entirely at the discretion of the issuing rating agency. A rating is not a recommendation
to purchase, sell or hold the Notes. Ratings do not reflect market prices or suitability of a security for a particular investor and
the rating of the Notes may not reflect all risks related to us and our business, or the structure or market value of the Notes. We may
elect to issue other securities for which we may seek to obtain a rating in the future. If we issue other securities with ratings lower
than market expectations or that are subsequently lowered or withdrawn, the market for or the market value of the Notes could be adversely
affected.
We
could enter into various transactions that could increase the amount of our outstanding debt, or adversely affect our capital structure
or credit rating.
Subject
to certain limited exceptions, the terms of the Notes do not prevent us from entering into a variety of acquisition, divestiture, refinancing,
recapitalization or other highly leveraged transactions. As a result, we could enter into any such transaction even though the transaction
could increase the total amount of our outstanding indebtedness, adversely affect our capital structure or credit rating or otherwise
adversely affect the holders of the Notes.
41
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item
3. Defaults Upon Senior Securities
Not
applicable.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
None.
Item
6. Exhibits
Exhibit
Number
Description
3.1
Certificate of Designation designating the Series B Cumulative Preferred Stock of the Company (incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of the Company filed with the SEC on May 5, 2021).
4.1
Indenture, dated as of April 20, 2021, by and between the Company and U.S. Bank National Association, as Trustee (incorporated herein by reference to Exhibit 4.1 to the Current Report on Form 8-K of the Company filed with the SEC on April 20, 2021).
4.2
First Supplemental Indenture, dated as of April 20, 2021, by and between the Company and U.S. Bank National Association, as Trustee (incorporated herein by reference to Exhibit 4.2 to the Current Report on Form 8-K of the Company filed with the SEC on April 20, 2021).
4.3
Form of 8.625% Senior Note due 2026 (included in Exhibit 4.2).
10.1
Securities Purchase Agreement, dated as of May 5, 2021, by and between the Company and B. Riley Securities, Inc. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed with the SEC on May 5, 2021).
10.2*#
License and Supply Agreement, dated as of July 25, 2021, by and between the Company and Sintetica, S.A.
10.3
First Amendment to the Harrow Health, Inc. 2017 Incentive Stock and Awards Plan (incorporated herein by reference to Appendix A to the Company’s Definitive Proxy Statement filed with the SEC on April 23, 2021).
31.1*
Certification of Mark L. Baum, principal executive officer, pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities and Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes- Oxley Act of 2002.
31.2*
Certification of Andrew R. Boll, principal financial and accounting officer, pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities and Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes- Oxley Act of 2002.
32.1**
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, executed by Mark L. Baum, principal executive officer, and Andrew R. Boll, principal financial and accounting officer.
101.INS*
Inline
XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within
the Inline XBRL document.
101.SCH*
Inline
XBRL Taxonomy Extension Schema Document
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
Inline
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
104
The
cover page from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, has been formatted in Inline
XBRL.
*
Filed
herewith.
**
Furnished
herewith.
#
Portions
of this exhibit have been omitted in compliance with Item 601 of Regulation S-K.
42
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
Harrow Health, Inc.
Dated:
August 10, 2021
By:
/s/
Mark L. Baum
Mark
L. Baum
Chief
Executive Officer and Director
(Principal
Executive Officer)
By:
/s/
Andrew R. Boll
Andrew
R. Boll
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
43
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.