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, 2023
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 Stock Market LLC
8.625%
Senior Notes due 2026
HROWL
The
Nasdaq Stock Market LLC
11.875%
Senior Notes due 2027
HROWM
The
Nasdaq Stock Market LLC
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, 2023, there were 35,115,254 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
32
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
40
Item
4.
Controls and Procedures
40
Part
II
OTHER INFORMATION
41
Item
1.
Legal Proceedings
41
Item
1A.
Risk Factors
41
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
41
Item
3.
Defaults Upon Senior Securities
41
Item
4.
Mine Safety Disclosures
41
Item
5.
Other Information
41
Item
6.
Exhibits
41
Signatures
42
2
PART
I
FINANCIAL
INFORMATION
Item
1. Financial Statements
HARROW
HEALTH, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
June 30,
December 31,
2023
2022
(Unaudited)
ASSETS
Current assets
Cash and cash equivalents
$ 22,754,000
$ 96,270,000
Investment in Eton Pharmaceuticals
6,917,000
5,589,000
Accounts receivable, net
18,258,000
6,249,000
Inventories
8,555,000
6,541,000
Prepaid expenses and other current assets
3,812,000
3,611,000
Total current assets
60,296,000
118,260,000
Property, plant and equipment, net
3,633,000
3,486,000
Capitalized software costs, net
2,136,000
2,112,000
Deferred financing costs
-
1,950,000
Deferred tax asset
288,000
-
Operating lease right-of-use assets, net
7,156,000
7,513,000
Intangible assets, net
150,148,000
23,725,000
Goodwill
332,000
332,000
TOTAL ASSETS
$ 223,989,000
$ 157,378,000
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable and accrued expenses
$ 17,822,000
$ 13,771,000
Accrued payroll and related liabilities
4,293,000
4,025,000
Deferred revenue and customer deposits
132,000
113,000
Current portion of operating lease obligations
764,000
723,000
Total current liabilities
23,011,000
18,632,000
Operating lease obligations, net of current portion
6,939,000
7,332,000
Accrued expenses, net of current portion
2,275,000
-
Notes payable, net of unamortized debt discount
169,712,000
104,174,000
TOTAL LIABILITIES
201,937,000
130,138,000
Commitments and contingencies
-
-
STOCKHOLDERS’ EQUITY
Common stock, $ 0.001 par value, 50,000,000 shares authorized, 30,276,938 and 29,901,530
shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively
30,000
30,000
Additional paid-in capital
142,742,000
137,058,000
Accumulated deficit
( 120,365,000 )
( 109,493,000 )
TOTAL HARROW HEALTH STOCKHOLDERS’ EQUITY
22,407,000
27,595,000
Noncontrolling interests
( 355,000 )
( 355,000 )
TOTAL STOCKHOLDERS’ EQUITY
22,052,000
27,240,000
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 223,989,000
$ 157,378,000
The accompanying notes are
an integral part of these unaudited condensed consolidated financial statements
3
HARROW
HEALTH, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
2023
2022
2023
2022
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2023
2022
2023
2022
Revenues:
Product sales, net
$ 29,542,000
$ 21,518,000
$ 49,995,000
$ 41,858,000
Other revenues
3,928,000
1,805,000
9,578,000
3,585,000
Total revenues
33,470,000
23,323,000
59,573,000
45,443,000
Cost of sales
( 10,000,000 )
( 6,534,000 )
( 18,271,000 )
( 12,497,000 )
Gross profit
23,470,000
16,789,000
41,302,000
32,946,000
Operating expenses:
Selling, general and administrative
19,957,000
14,185,000
35,845,000
27,583,000
Research and development
1,161,000
914,000
1,895,000
1,572,000
Total operating expenses
21,118,000
15,099,000
37,740,000
29,155,000
Income from operations
2,352,000
1,690,000
3,562,000
3,791,000
Other(expense) income :
Interest expense, net
( 5,704,000 )
( 1,794,000 )
( 10,451,000 )
( 3,586,000 )
Equity in losses of unconsolidated entities
-
( 2,646,000 )
-
( 5,532,000 )
Investment (loss) gain from Eton Pharmaceuticals
( 714,000 )
( 3,449,000 )
1,328,000
( 3,310,000 )
Loss on extinguishment of debt
-
-
( 5,465,000 )
-
Other expense, net
( 178,000 )
-
( 149,000 )
-
Total other expense, net
( 6,596,000 )
( 7,889,000 )
( 14,737,000 )
( 12,428,000 )
Loss before income taxes
( 4,244,000 )
( 6,199,000 )
( 11,175,000 )
( 8,637,000 )
Income tax benefit (expense)
15,000
( 40,000 )
303,000
( 40,000 )
Net loss attributable to Harrow Health, Inc.
$ ( 4,229,000 )
$ ( 6,239,000 )
$ ( 10,872,000 )
$ ( 8,677,000 )
Basic and diluted net loss per share of common stock
$ ( 0.14 )
$ ( 0.23 )
$ ( 0.36 )
$ ( 0.32 )
Weighted average number of shares of common stock outstanding, basic and diluted
30,458,677
27,303,458
30,379,354
27,265,350
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
4
HARROW
HEALTH, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
For
the periods ended June 30, 2023 and 2022
Total
Common Stock
Additional
Harrow Health, Inc.
Total
Total
Par
Paid-in
Accumulated
Stockholders’
Noncontrolling
Stockholders’
Shares
Value
Capital
Deficit
Equity
Interests
Equity
Balance at December 31, 2021
26,902,763
$ 27,000
$ 106,666,000
$ ( 95,407,000 )
$ 11,286,000
$ ( 355,000 )
$ 10,931,000
Issuance of common stock in connection with:
Exercise of employee stock-based options
91,986
-
7,000
-
7,000
-
7,000
Vesting of RSUs
185,000
1,000
( 1,000 )
-
-
-
-
Shares withheld related to net share settlement of equity awards
( 109,771 )
( 1,000 )
( 875,000 )
-
( 876,000 )
-
( 876,000 )
Stock-based compensation expense
-
-
4,009,000
-
4,009,000
-
4,009,000
Net loss
-
-
-
( 8,677,000 )
( 8,677,000 )
-
( 8,677,000 )
Balance at June 30, 2022
27,069,978
$ 27,000
$ 109,806,000
$ ( 104,084,000 )
$ 5,749,000
$ ( 355,000 )
$ 5,394,000
Balance at December 31, 2022
29,901,530
$ 30,000
$ 137,058,000
$ ( 109,493,000 )
$ 27,595,000
$ ( 355,000 )
$ 27,240,000
Issuance of common stock in connection with:
Exercise of consultant stock-based options
10,000
-
85,000
-
85,000
-
85,000
Exercise of employee stock-based options
216,816
-
252,000
-
252,000
-
252,000
Vesting of RSUs
242,760
-
-
-
-
-
-
Shares withheld related to net share settlement of equity awards
( 94,168 )
-
( 1,698,000 )
-
( 1,698,000 )
-
( 1,698,000 )
Stock-based compensation expense
-
-
7,045,000
-
7,045,000
-
7,045,000
Net loss
-
-
-
( 10,872,000 )
( 10,872,000 )
-
( 10,872,000 )
Balance at June 30, 2023
30,276,938
$ 30,000
$ 142,742,000
$ ( 120,365,000 )
$ 22,407,000
$ ( 355,000 )
$ 22,052,000
Total
Common Stock
Additional
Harrow Health, Inc.
Total
Total
Par
Paid-in
Accumulated
Stockholders’
Noncontrolling
Stockholders’
Shares
Value
Capital
Deficit
Equity
Interests
Equity
Balance at March 31, 2022
27,031,127
$ 27,000
$ 107,909,000
$ ( 97,845,000 )
$ 10,091,000
$ ( 355,000 )
$ 9,736,000
Issuance of common stock in connection with:
Exercise of employee stock-based options
2,000
-
3,000
-
3,000
-
3,000
Vesting of RSUs
50,000
-
-
-
-
-
-
Shares withheld related to net share settlement of equity awards
( 13,149 )
-
( 99,000 )
-
( 99,000 )
-
( 99,000 )
Stock-based compensation expense
-
-
1,993,000
-
1,993,000
-
1,993,000
Net loss
-
-
-
( 6,239,000 )
( 6,239,000 )
-
( 6,239,000 )
Balance at June 30, 2022
27,069,978
$ 27,000
$ 109,806,000
$ ( 104,084,000 )
$ 5,749,000
$ ( 355,000 )
$ 5,394,000
Balance at March 31, 2023
30,056,370
$ 30,000
$ 137,989,000
$ ( 116,136,000 )
$ 21,883,000
$ ( 355,000 )
$ 21,528,000
Issuance of common stock in connection with:
Exercise of consultant stock-based options
10,000
-
85,000
-
85,000
-
85,000
Exercise of employee stock-based options
119,274
-
104,000
-
104,000
-
104,000
Vesting of RSUs
131,760
-
-
-
-
-
-
Shares withheld related to net share settlement of equity awards
( 40,466 )
-
( 848,000 )
-
( 848,000 )
-
( 848,000 )
Stock-based compensation expense
-
-
5,412,000
-
5,412,000
-
5,412,000
Net loss
-
-
-
( 4,229,000 )
( 4,229,000 )
-
( 4,229,000 )
Balance at June 30, 2023
30,276,938
$ 30,000
$ 142,742,000
$ ( 120,365,000 )
$ 22,407,000
$ ( 355,000 )
$ 22,052,000
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
2023
2022
For the Six Months Ended
June 30,
2023
2022
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$ ( 10,872,000 )
$ ( 8,677,000 )
Adjustments to reconcile net loss to net cash (used in) provided by operating activities:
Depreciation and amortization of property, plant and equipment and software development costs
690,000
843,000
Amortization of intangible assets
5,050,000
802,000
Amortization of operating lease right-of-use assets
357,000
263,000
Provision for credit losses
29,000
29,000
Amortization of debt issuance costs and debt discount
1,623,000
388,000
Investment (gain) loss from investment in Eton Pharmaceuticals
( 1,328,000 )
3,310,000
Equity in losses of unconsolidated entities
-
5,532,000
Loss on extinguishment of debt
5,465,000
-
Stock-based compensation
7,045,000
4,009,000
Deferred income taxes
( 288,000 )
-
Changes in assets and liabilities:
Accounts receivable
( 12,038,000 )
( 2,314,000 )
Inventories
( 2,014,000 )
( 915,000 )
Prepaid expenses and other current assets
( 201,000 )
120,000
Accounts payable and accrued expenses
3,584,000
2,454,000
Accrued payroll and related liabilities
( 769,000 )
( 84,000 )
Deferred revenue and customer deposits
19,000
67,000
NET CASH (USED IN) PROVIDED BY OPERATING ACTIVITIES
( 3,648,000 )
5,827,000
CASH FLOWS FROM INVESTING ACTIVITIES
Investment in patent and trademark assets
-
( 5,000 )
Purchase of product NDAs and patents
( 131,473,000 )
-
Purchases of property, plant and equipment
( 746,000 )
( 664,000 )
NET CASH USED IN INVESTING ACTIVITIES
( 132,219,000 )
( 669,000 )
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from 11.875% notes payable, net of costs
4,961,000
-
Proceeds from Oaktree loan, net of costs
61,585,000
-
Payment of taxes upon vesting of RSUs and exercise of stock options
( 661,000 )
( 876,000 )
Proceeds from exercise of stock options
337,000
7,000
Proceeds from B. Riley senior secured note, net of costs
55,879,000
-
Repayment of B. Riley senior secured note
( 59,750,000 )
-
Payments on finance lease obligations
-
( 18,000 )
NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES
62,351,000
( 887,000 )
NET CHANGE IN CASH, CASH EQUIVALENTS
( 73,516,000 )
4,271,000
CASH, CASH EQUIVALENTS, beginning of period
96,270,000
42,167,000
CASH, CASH EQUIVALENTS, end of period
$ 22,754,000
$ 46,438,000
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for income taxes
$ 4,000
$ 40,000
Cash paid for interest
$ 8,076,000
$ 3,234,000
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Purchase of property, plant and equipment included in accounts payable and accrued expenses
$ 115,000
$ 275,000
Right-of-use assets obtained in exchange for new operating lease obligations
$ -
$ 2,188,000
Accrual of exit fee related to Oaktree Loan
$ 2,275,000
$ -
Reclassification of deferred financing costs
$ 1,950,000
$ -
Income taxes owed for exercise of options
$ 1,037,000
$ -
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
6
HARROW
HEALTH, INC.
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
the Three and Six Months Ended June 30, 2023 and 2022
NOTE
1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
Company
and Background
Harrow
Health, Inc. (together with its subsidiaries, partially owned companies and royalty arrangements unless the context indicates or otherwise
requires, the “Company” or “Harrow”) is a leading eyecare pharmaceutical company engaged in the discovery, development,
and commercialization of innovative ophthalmic pharmaceutical products for the U.S. market. Harrow helps U.S. eyecare professionals preserve
the gift of sight by making its comprehensive portfolio of prescription and non-prescription pharmaceutical products accessible and affordable
to millions of Americans each year. The Company own commercial rights to one of the largest portfolios of branded ophthalmic pharmaceutical
products in the U.S. that are marketed under its Harrow name. The Company also owns and operates ImprimisRx, one of the nation’s
leading ophthalmology-focused pharmaceutical-compounding businesses.
The
Company owns non-controlling equity interests in Surface Ophthalmics, Inc. (“Surface”) and Melt Pharmaceuticals, Inc. (“Melt”),
both companies that began as subsidiaries of Harrow. 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, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023 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, 2022.
The
accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned and majority-owned
subsidiaries.
Harrow
consolidates entities in which it has a controlling financial interest. The Company assesses control under the variable interest entity
(“VIE”) model to determine whether the Company is the primary beneficiary of that entity. The Company consolidates (i) entities
in which it holds and/or controls, directly or indirectly, more than 50% of the voting rights , and (ii) VIEs for which the Company is
deemed to be the primary beneficiary. All intercompany accounts and transactions have been eliminated in consolidation.
NOTE
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The
following represents an update for the three and six months ended June 30, 2023 to the significant accounting policies described in the
Company’s Annual Report on Form 10-K for the year ended December 31, 2022.
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.
Credit
Losses
The
Company estimates and records a provision for its expected credit losses related to its financial instruments, including its trade receivables,
management considers historical collection rates, the current financial status of the Company’s customers, macroeconomic factors,
and other industry-specific factors when evaluating for current expected credit losses. Forward-looking information is also considered
in the evaluation of current expected credit losses. However, because of the short time to the expected receipt of accounts receivable,
management believes that the carrying value, net of expected losses, approximates fair value and therefore, relies more on historical
and current analysis of such financial instruments, including its trade receivables.
7
To
determine the provision for credit losses for accounts receivable, the Company has disaggregated its accounts receivable by class of
customer at the business component level, as management determined that risk profile of the Company’s customers is consistent based
on the type and industry in which they operate, mainly in the pharmaceuticals industry. Each business component is analyzed for estimated
credit losses individually. In doing so, the Company establishes a historical loss matrix, based on the previous collections of accounts
receivable by the age of such receivables, and evaluates the current and forecasted financial position of its customers, as available.
Further, the Company considers macroeconomic factors and the status of the pharmaceuticals industry to estimate if there are current
expected credit losses within its trade receivables based on the trends of the Company’s expectation of the future status of such
economic and industry-specific factors. Also, specific allowance amounts are established based on review of outstanding invoices to record
the appropriate provision for customers that have a higher probability of default.
The
accounts receivable balance on the Company’s condensed consolidated balance sheet as of June 30, 2023 was $ 18,258,000 , net of $ 75,000
of allowances. The following table provides a roll-forward of the allowance for credit losses that is deducted from the amortized cost
basis of accounts receivable to present the net amount expected to be collected at June 30, 2023:
SCHEDULE
OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS
Balance at January 1, 2023
$ 73,000
Change in expected credit losses
29,000
Write-offs, net of recoveries
( 27,000 )
Balance at June 30, 2023
$ 75,000
Business
Combinations and Asset Acquisitions
The
Company evaluates acquisitions of assets and other similar transactions to assess whether the transaction should be accounted for as
a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross
assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction
is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether the Company has acquired
inputs, process, and output, which would meet the requirements of a business. If determined to be a business combination, the Company
accounts for the transaction under the acquisition method of accounting as indicated in Financial Accounting Standards Board (“FASB”).
Accounting
Standards Codification (“ASC”) 805, Business Combinations , requires the acquiring entity in a business combination
to recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquiree and establishes
the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed
in business combinations, including any contingent assets and liabilities, and any non-controlling interest in the acquiree based on
the fair value estimates as of the date of acquisition. The Company recognizes and measures goodwill as of the acquisition date, as the
excess of the fair value of the consideration paid over the fair value of the identified net assets acquired.
The
consideration for the Company’s business acquisitions may include future payments that are contingent upon the occurrence of a
particular event or events. The obligation for such contingent consideration payments are recorded at fair value on the acquisition date.
The contingent consideration obligations are then evaluated each reporting period. Changes in the fair value of contingent consideration,
other than changes due to payments, would be recognized as a gain or loss and recorded in the condensed consolidated statement of operations.
8
If
determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50 Business Combinations – Related
Issues , which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on
the cost to the acquiring entity or a relative fair value basis, which includes transaction costs in addition to consideration given.
No gain or loss is recognized as of the date of acquisition unless the fair value of non-cash assets given as consideration differs from
the assets’ carrying amounts on the acquiring entity’s financial statements. Consideration transferred that is non-cash will
be measured based on either the cost (which shall be measured based on the fair value of the consideration given) or the fair value of
the assets acquired, and liabilities assumed, whichever is more clearly evident and more reliably measurable. Goodwill is not recognized
in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable
assets based on relative fair values.
Fair
Value Measurements
Fair
value measurements are determined based on the assumptions that market participants would use in pricing an asset or liability. GAAP
establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of
unobservable inputs by requiring that the most observable inputs be used when available. The established fair value hierarchy prioritizes
the use of inputs used in valuation methodologies into the following three levels:
●
Level
1: Applies to assets or liabilities for which there are quoted prices (unadjusted) for identical assets or liabilities in active
markets. A quoted price in an active market provides the most reliable evidence of fair value and must be used to measure fair value
whenever available.
●
Level
2: Applies to assets or liabilities for which there are significant other observable inputs other than Level 1 prices, such as quoted
prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can
be corroborated by observable market data.
●
Level
3: Applies to assets or liabilities for which there are significant unobservable inputs that reflect a reporting entity’s own
assumptions about the assumptions that market participants would use in pricing an asset or liability. For example, Level 3 inputs
would relate to forecasts of future earnings and cash flows used in a discounted future cash flows method.
At
June 30, 2023 and December 31, 2022, the Company measured its investment in Eton Pharmaceuticals, Inc. (“Eton”) on a recurring
basis. The Company’s investment in Eton is classified as Level 1 as the fair value is determined using quoted market prices in
active markets for the same securities. As of June 30, 2023 and December 31, 2022, the fair market value of the Company’s investment
in Eton was $ 6,917,000 and $ 5,589,000 , respectively.
The
Company carries the 2026 Notes at face value, including the unamortized premium, less unamortized debt issuance costs, the 2027
Notes are carried at face value less unamortized debt issuance costs, and the Oaktree Loan (as defined in Note 13) is carried at
face value less the original issue discount and unamortized debt issuance costs on the condensed consolidated balance sheets and the
Company presents fair value for disclosure purposes only. The 2026 Notes and 2027 Notes are classified as Level 1 instruments as the
fair value is determined using quoted market prices in active markets for the same securities. The Oaktree Loan is classified as a Level 2 instrument and its fair value is determined through an income approach
that considers collateral coverage, yield calibration, yield analysis and any adjustments to implied yield associated with the Company’s
fundamental measures.
The
following table presents the estimated fair values and the carrying values:
SCHEDULE OF ESTIMATED FAIR VALUE
June 30, 2023
December 31, 2022
Carrying Value
Fair Value
Carrying Value
Fair Value
2026 Notes
$ 72,823,000
$ 74,550,000
$ 72,436,000
$ 71,550,000
2027 Notes
$ 37,053,000
$ 40,604,000
$ 31,738,000
$ 35,112,000
Oaktree Loan
$ 59,836,000
$ 63,661,000
$ -
$ -
The
Company’s other financial instruments include cash and cash equivalents, accounts receivable, accounts payable and accrued expenses,
accrued payroll and related liabilities, deferred revenue and customer deposits and operating lease liabilities. The carrying amount
of these financial instruments, except for operating lease liabilities, approximates fair value due to the short-term maturities of these
instruments. Based on borrowing rates currently available to the Company, the carrying value of the operating lease liabilities approximate
their respective fair values.
9
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, restricted
stock units (“RSUs”), performance stock units (“PSUs”), and warrants, outstanding during the period. Common equivalent
shares (using the treasury stock method) from stock options, unvested RSUs, unvested PSUs and warrants were 6,131,026 and 5,646,672 at
June 30, 2023 and 2022, respectively, and are excluded in the calculation of diluted net loss per common share for the periods presented,
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, 2023 and 2022 was 234,027 and 287,049 , respectively.
The
following table shows the computation of basic net loss per share of common stock for the three and six months ended June 30, 2023 and
2022:
SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE
June 30, 2023
June 30, 2022
June 30, 2023
June 30, 2022
For the Three Months Ended
For the Six Months Ended
June 30, 2023
June 30, 2022
June 30, 2023
June 30, 2022
Numerator – net loss
$ ( 4,229,000 )
$ ( 6,239,000 )
$ ( 10,872,000 )
$ ( 8,677,000 )
Denominator – weighted average number of shares outstanding, basic and diluted
30,458,677
27,303,458
30,379,354
27,265,350
Net loss per share, basic and diluted
$ ( 0.14 )
$ ( 0.23 )
$ ( 0.36 )
$ ( 0.32 )
Income
Taxes
The
Company’s effective tax rate was ( 2.71 ) % and 0.46 % for the six months ended June 30, 2023 and 2022, respectively. The Company’s
effective tax rate for the six months ended June 30, 2023 and 2022 differs from the U.S. federal statutory tax rate of 21 % due to state
taxes, permanent book-tax differences related to Internal Revenue Code of 1986, as amended (“IRC”), Section 162(m) excess
officer compensation limitation and share-based compensation and the change in valuation allowance.
As
of June 30, 2023 and December 31, 2022, there were no unrecognized tax benefits included in the condensed consolidated balance sheets
that would, if recognized, affect the effective tax rate.
Investment
in Eton Pharmaceuticals, Inc.
As
of June 30, 2023, the Company owned 1,982,000 shares of Eton common stock, which represents less than 10 % of the equity interests of
Eton. At June 30, 2023, the fair market value of Eton’s common stock was $ 3.49 per share. In accordance with ASC 321, Investments
— Equity Securities , the Company recorded unrealized holding gains and (losses) from its Eton common stock position of
$ ( 714,000 ) and $ 1,328,000 during the three and six months ended June 30, 2023, respectively, and $ ( 3,449,000 ) and $ ( 3,310,000 )
during the same periods in 2022, respectively, related to the change in fair market value of its investment in Eton during the
measurement period. As of June 30, 2023, the fair market value of the Company’s investment in Eton was $ 6,917,000 .
Investment
in Melt Pharmaceuticals, Inc. – Related Party
The
Company owns 3,500,000 shares of common stock of Melt (representing approximately 46 % of the equity interests of Melt as of June 30,
2023). The Company analyzes its investment in Melt and related agreements on a regular basis to evaluate its position of variable interests
in Melt. The Company has determined that it does not have the ability to control Melt, however it has the ability to exercise significant
influence over the operating and financial decisions of Melt and uses the equity method of accounting for this investment. 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. Any intra-entity profits and losses are eliminated. During the year ended December 31,
2021, the Company reduced the carrying value of its common stock investment in Melt to $ 0 as a result of the Company recording its share
of equity losses in Melt since its deconsolidation in 2019. As of June 30, 2023, and at the time of entering into the Melt Loan Agreement
(see Note 5), the Company owned 100 % of Melt’s indebtedness. Following the reduction of the carrying value of the Company’s
common stock investment in Melt to $ 0 , the Company began recording 100 % of the equity method losses of Melt, based on its ownership of
Melt’s total indebtedness. In addition, the Company treats interest paid in kind on the Melt Loan Agreement as an in-substance
capital contribution and reduces its investment in Melt accordingly, rather than recording interest income. The Company has no other
requirements to advance funds to Melt.
10
The
following table summarizes the Company’s investments in Melt as of June 30, 2023:
SCHEDULE OF INVESTMENT
Cost
Share of Equity Method
Paid-in-Kind
In-substance Capital
Net
Basis
Losses
Interest
Contributions
Carrying value
Common stock
$ 5,810,000
$ ( 5,810,000 )
$ -
$
$ -
Note receivable
13,500,000
( 13,500,000 )
3,566,000
( 3,566,000 )
-
$ 19,310,000
$ ( 19,310,000 )
$ 3,566,000
$ ( 3,566,000 )
$ -
See
Note 5 for more information and related party disclosure regarding Melt.
Investment
in Surface Ophthalmics, Inc. – Related Party
The
Company owns 3,500,000 common shares of Surface (representing approximately 20 % of Surface’s equity interests following the closing
of a round of financing completed by Surface in July 2021) 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. During the year ended December 31, 2021, the Company
reduced its common stock investment in Surface to $ 0 as a result of the Company recording its share of equity losses of Surface. The
Company has no other investments in Surface and no other requirements to advance funds to Surface.
The
following table summarizes the Company’s investment in Surface as of June 30, 2023:
SCHEDULE OF INVESTMENT
Cost
Share of Equity
Net
Basis
Method Losses
Carrying value
Common stock
$ 5,320,000
$ ( 5,320,000 )
$ -
See
Note 6 for more information and related party disclosure regarding Surface.
Recently
Adopted Accounting Pronouncements
In
June 2016, FASB issued Accounting Standards Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments .
This ASU replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and
requires consideration of a broader range of reasonable and supportable information for credit loss estimates on certain types of financial
instruments, including trade receivables. In addition, new disclosures are required. The ASU, as subsequently amended, is effective for
the Company for the fiscal years beginning after December 15, 2022. The Company adopted ASU 2016-13 on January 1, 2023. Based on the
composition of the Company’s accounts receivable, investment portfolio, and other financial assets, including current market conditions
and historical credit loss activity, the adoption of this standard did not have a material impact on the Company’s consolidated
financial statements or disclosures. Specifically, the Company’s estimate of expected credit losses as of June 30, 2023, using
its expected credit loss evaluation process described above, resulted in no adjustments to the provision for credit losses and no cumulative-effect
adjustment to accumulated deficit on the adoption date of the standard.
11
NOTE
3. REVENUES
The
Company accounts for contracts with customers in accordance with ASC 606, Revenue from Contracts with Customers . The Company has
three primary streams of revenue: (1) revenue recognized from sales of products through its pharmacy and outsourcing facility and sales
of branded products to wholesalers through a third-party logistics (“3PL”) partner, (2) revenue recognized from a commission
agreement with a third party, and (3) revenue recognized from intellectual property licenses and asset purchase agreements.
Product
Revenues
The
Company sells prescription medications directly through its pharmacy, outsourcing facility and 3PL partner. Revenue from the Company’s
pharmacy services includes: (i) the portion of the price the client pays directly to the Company, net of any volume-related or other
discounts paid back to the client, (ii) the price paid to the Company 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, the Company has identified the
following:
1.
Identify
the contract(s) with a customer: A contract is deemed to exist when the customer places an order through receipt of a prescription,
via an online order or via receipt of a purchase order from a customer. For branded products, orders are received through the Company’s
3PL partner, and the customer takes title of the products via formal purchase orders placed and fulfilled.
2.
Identify
the performance obligations in the contract: Obligations for fulfillment of the Company’s
contracts consist of delivering the product to customers at their specified destination.
For shipping and handling activities under ASC 606, if the customer takes control of the
goods after shipment, shipping and handling activities would always be considered a fulfillment
activity and not treated as a separate performance obligation. If the customer takes control
of the goods before shipment, entities must make an accounting policy election to treat shipping
and handling activities as either a fulfillment cost or as a separate performance obligation.
The Company has elected to treat its shipping and handling activities as a fulfillment cost.
3.
Determine
the transaction price: The transaction price is based on an amount that reflects the
consideration to which the Company expects to be entitled, net of accruals for estimated
rebates, wholesaler chargebacks, discounts and other deductions (collectively, sales deductions)
and an estimate for returns and replacements established at the time of sale. The Company
utilizes the services of a third-party professional services firm to estimate rebates and
chargebacks associated with sales of its branded products. The transfer of promised goods
is satisfied within a year, and therefore there are no significant financing components.
There is no non-cash consideration related to product sales.
4.
Allocate
the transaction price to the performance obligations in the contract: Because there is only one performance obligation for product
sales, no allocation is necessary.
5.
Recognize
revenue when (or as) the entity satisfies a performance obligation: Revenue from products is recognized upon transfer of control
of a product to a customer. This generally occurs upon shipment unless contractual terms with a customer state that transfer of control
occurs at delivery.
Commission
Revenues
The
Company had entered into an agreement whereby it was paid a fee calculated based on sales the Company generates from a pharmaceutical
product that is owned by a third party. The revenue earned from this arrangement was recognized, at which point there was no future performance
obligation required by the Company and no consequential continuing involvement on the Company’s part to recognize the associated
revenue.
12
Revenues
From Transfer of Acquired Product Profit
The
Company entered into an agreement whereby it purchased the exclusive commercial rights to assets associated with certain ophthalmic products
from another pharmaceutical company (the “Seller”). During a temporary, transition period, the Seller continues to manufacture
and market these products and transfer the net profit from the sale of the products to the Company. The revenue recognized by the Company
from the transfer of net profit was recognized at the time profit from the product sales were calculated by the Seller and confirmed
by the Company, typically on a monthly basis, at which point there is no future performance obligation required by the Company and no
consequential continuing involvement on the Company’s part to recognize the associated revenue. On a quarterly basis, the Seller
invoices the Company for all credits and reimbursements (“Chargebacks”) made to customers related to the products. The Company
uses historical actual experience to estimate Chargebacks associated with the net profit transferred. The estimate is recorded as a reduction
in revenues in the Company’s condensed consolidated statements of operations and accounts receivable in the condensed consolidated
balance sheets, at the time the revenue is recognized.
Intellectual
Property License Revenues
The
Company currently holds five intellectual property licenses and related agreements pursuant to which the Company has agreed to license
or sell to 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 that 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.
Revenue
disaggregated by revenue source for the three and six months ended June 30, 2023 and 2022 consisted of the following:
SCHEDULE OF DISAGGREGATED REVENUE
2023
2022
2023
2022
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2023
2022
2023
2022
Product sales, net
$ 29,542,000
$ 21,518,000
$ 49,995,000
$ 41,858,000
Commission revenues
-
1,212,000
-
2,532,000
Transfer of acquired product profit
3,928,000
593,000
9,578,000
1,053,000
Total revenues
$ 33,470,000
$ 23,323,000
$ 59,573,000
$ 45,443,000
Deferred
revenue and customer deposits at June 30, 2023 and December 31, 2022 were $ 132,000 and $ 113,000 , respectively. All deferred revenue and
customer deposit amounts at December 31, 2022 were recognized as revenue during the six months ended June 30, 2023.
NOTE
4. RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES
Acquisition
of ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE
In
December 2022, the Company entered into an Asset Purchase Agreement (the “Fab 5 APA”) with Novartis Technology, LLC and Novartis
Innovative Therapies AG (together, “Novartis”), pursuant to which the Company agreed to purchase from Novartis the exclusive
commercial rights to assets associated with the following ophthalmic products (collectively the “Fab 5 Products”) in the
U.S. (the “Fab 5 Acquisition”): ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE.
13
Under
the terms of the Fab 5 APA, the Company made a one-time payment of $ 130,000,000 at closing in January 2023, with up to another $ 45,000,000
due in a milestone payment related to the timing of the commercial availability of TRIESENCE. Pursuant to the Fab 5 APA and various ancillary
agreements, immediately following the closing and subject to certain conditions and prior to the transfer of the Fab 5 Products new drug
applications (the “NDAs”) to the Company, Novartis will continue to sell the Fab 5 Products on the Company’s behalf
and transfer the net profit from the sale of the Fab 5 Products to the Company. Novartis has agreed to supply certain Fab 5 Products
to the Company for a period of time after the NDAs are transferred and to assist with technology transfer of the Fab 5 Products manufacturing
to other third-party manufacturers, if needed.
The
assets acquired in the Fab 5 Acquisition are identifiable intangible asset groups in similar asset classes and all directly related to
the five product NDAs acquired. The developed technology is within one major intangible asset class. No workforce/employees were included
in the Fab 5 Acquisition and the Company is required to utilize its own business inputs/processes to transfer and commercialize the Fab
5 Products and NDAs.
The
Company incurred $ 558,000 in costs associated with the Fab 5 Acquisition, including the acquisition costs and the payment of $ 130,000,000
at closing, the total purchase price of the Fab 5 Acquisition was $ 130,558,000 and was accounted for as an asset acquisition. At the
time of the Fab 5 Acquisition and as of June 30, 2023, the contingent consideration due related to the commercial availability of TRIESENCE
was not considered probable and reasonably estimable, therefore no amount was included in the purchase price of the Fab 5 Acquisition.
At the time the contingent consideration due related to the commercial availability of TRIESENCE becomes probable and reasonably estimable
the additional consideration, if any, paid will be allocated to all of the assets on a pro rata basis based on their initial estimated
fair values as a percent of the total purchase price. The Company does not consider any amounts related to TRIESENCE to be in-process
research and development (IPR&D) as considered within the scope of ASC 730, Research and Development .
Divestiture
of Non-Ophthalmic Assets
In
October 2022, wholly-owned subsidiaries of the Company (collectively, “Imprimis”) entered into an Asset Purchase Agreement
(the “RPC Agreement”) with Innovation Compounding Pharmacy, LLC (the “Buyer”). Under the terms of the RPC Agreement,
Imprimis agreed to sell substantially all of its assets associated with its non-ophthalmology related compounding product line, including
but not limited to, certain intellectual property rights, customer lists, databases, and formulations (the “RPC Assets”).
The Buyer agreed to make offers of employment to six of the Company’s employees that were responsible for the sales activities
associated with the RPC Assets. Under the terms of the RPC Agreement, the Buyer paid Imprimis an aggregate cash amount of $ 6,000,000
in October 2022. In addition, the Buyer is obligated to pay up to $ 4,500,000 to Imprimis based on mutually agreed upon revenue milestones
during the calendar year 2023 (the “Contingent Amount”). During the year ended December 31, 2022, no amount related to the
Contingent Amount was recognized by the Company. The Company will recognize a gain related to the Contingent Amount if/when the contingency
(in this case, revenue thresholds for 2023) become likely and reasonably estimated.
In
connection with the RPC Agreement, Imprimis entered into a separate transition services agreement with the Buyer related to providing
ongoing services associated with the RPC Assets, such as procuring and dispensing prescription orders, providing accounting and billing
services and collecting accounts receivable. Imprimis provided transition services to the Buyer for approximately nine months following
the effective date of the RPC Agreement and expects to wind down transition services in subsequent periods. The Company collected and
will continue to collect cash on behalf of the Buyer for revenue generated by sales of RPC Assets from October 2022 through the transition
period and the Company is obligated to transfer cash generated by such sales to the Buyer. The Company’s condensed consolidated
balance sheet as of June 30, 2023 reflected $ 74,000 of cash collected on behalf of the Buyer and a receivable within accounts receivable
of $ 59,000 for cash to be collected on behalf of the Buyer for sales of RPC Assets sold through June 30, 2023.
The
amount due from the Buyer for reimbursement of services performed under the transition services agreement was $ 27,000 as of June 30,
2023. Such amount was netted against the amounts collected on behalf of the Buyer and was unpaid within accrued expenses on the condensed
consolidated balance sheet as of June 30, 2023. The combined total of $ 106,000 was recorded within accrued expenses on the condensed
consolidated balance sheet as of June 30, 2023, and represents a payable to the Buyer. The Company recorded a loss from the transition
services agreement and disposition and sale of certain related assets and unusable inventory of $ 203,000 and $ 171,000 during the three
and six months ended June 30, 2023, respectively, which is presented in other expense, net on the condensed consolidated statement of
operations.
See
Note 18 for additional information regarding recent product acquisitions and licenses.
14
NOTE
5. INVESTMENT IN, AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC. - RELATED PARTY TRANSACTIONS
In
December 2018, the Company entered into an asset purchase agreement with Melt (the “Melt Asset Purchase Agreement”). Pursuant
to the terms of the Melt Asset Purchase Agreement, Melt was assigned certain intellectual property and related rights from the Company
to develop, formulate, make, sell, and sub-license certain Company conscious sedation and analgesia related formulations (collectively,
the “Melt Products”). Under the terms of the Melt Asset Purchase Agreement, Melt is required to make mid-single digit royalty
payments to the Company on net sales of the Melt Products while any patent rights remain outstanding, as well as other conditions.
In
February 2019, the Company and Melt entered into a Management Service Agreement between the Company and Melt (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 $ 10,000 . During the three and six months ended June 30,
2023 and 2022, the Company recorded $ 30,000 and $ 89,000 and $ 40,000 and $ 70,000 , respectively, due from Melt for reimbursable expenses
and amounts payable pursuant to the Melt MSA, which are included in prepaid expenses and other current assets in the accompanying condensed
consolidated balance sheets. In addition, during the three and six months ended June 30, 2023, the Company advanced Melt $ 500,000 , which
amount was repaid to the Company by Melt subsequent to June 30, 2023. As of June 30, 2023 and December 31, 2022, the Company was due
$ 728,000 and $ 139,000 , 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, 2023.
The
Company’s Chief Executive Officer, Mark L. Baum, was previously a member of the Melt board of directors until his resignation during
the year ended December 31, 2021. Mr. Baum re-joined the Melt board of directors in January 2023. At the time Mr. Baum re-joined, the
Melt board of directors consists of five total board members, including Mr. Baum, who is the only representative of the Company on Melt’s
board of directors.
The
unaudited condensed results of operations information of Melt is summarized below:
SCHEDULE
OF CONDENSED INCOME STATEMENT
2023
2022
For the Six Months Ended
June 30,
2023
2022
Revenues, net
$ -
$ -
Loss from operations
$ ( 2,448,000 )
$ ( 5,532,000 )
Net loss
$ ( 3,551,000 )
$ ( 6,518,000 )
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE
OF CONDENSED BALANCE SHEET
At June 30,
At December 31,
2023
2022
Current assets
$ 93,000
$ 655,000
Non-current assets
97,000
107,000
Total assets
$ 190,000
$ 762,000
Total liabilities
$ 21,783,000
$ 19,056,000
Total preferred stock and stockholders’ deficit
( 21,593,000 )
( 18,294,000 )
Total liabilities and stockholders’ deficit
$ 190,000
$ 762,000
15
Melt
Note Receivable
On
September 1, 2021, the Company entered into a loan and security agreement in the principal amount of $ 13,500,000 (the “Melt Loan
Agreement”), as lender, with Melt, as borrower. Amounts borrowed under the Melt Loan Agreement bear interest at 12.50 % per annum,
which interest can be paid in-kind at the option of Melt until the maturity date. The Melt Loan Agreement permits Melt to pay interest
only on the principal amount loaned thereunder through the term and all amounts owed were previously due and payable on September 1,
2022. In April 2022, the Company entered into a First Amendment and in September 2022, a Second Amendment (together, the “Amendments”)
to the Melt Loan Agreement. The Amendments (i) extended the maturity date of the Melt Loan Agreement to June 1, 2023, which can be extended
further to September 1, 2026 upon Melt completing a qualifying financing of a minimum amount of $ 10,000,000 from third-party investors,
(ii) added conditions related to minimum cash amounts following a qualifying financing, and (iii) clarified the definition of material
adverse effects. Melt may elect to prepay all, but not less than all, of the amounts owed prior to the maturity date at any time without
penalty.
Melt
has granted the Company a security interest in substantially all of its personal property, rights and assets, including intellectual
property rights, to secure the payment of all amounts owed under the Melt Loan Agreement. The Melt Loan Agreement contains customary
representations, warranties and covenants, including covenants by Melt limiting additional indebtedness, liens, mergers and acquisitions,
dispositions, investments, distributions, subordinated debt, and transactions with affiliates. The Melt Loan Agreement includes customary
events of default, and upon the occurrence of an event of default (subject to cure periods for certain events of default), all amounts
owed by Melt thereunder may be declared immediately due and payable by the Company, and the interest rate on the loan may be increased
by 3 % per annum. The Melt Loan Agreement is currently in default due to non-payment on June 1, 2023 and the Company and Melt are involved
in ongoing discussions to resolve the default.
In
connection with the Melt Loan Agreement, the Company and Melt entered into a Right of First Refusal Agreement providing the Company with
the right, but not the obligation, to match any offer received by Melt associated with the commercial rights to any of Melt’s drug
candidates for a period of five years following the effective date of the Melt Loan Agreement.
The
net funds received by Melt excluded $ 908,000 owed to the Company for reimbursable expenses and amounts due under the Melt MSA prior to
the effective date of the note receivable. As of June 30, 2023 and December 31, 2022, aggregate principal and accrued interest payable
to the Company pursuant to the Melt Loan Agreement amounted to $ 17,066,000 and $ 15,984,000 , respectively. In accordance with ASC 323,
Investments – Equity Method and Joint Ventures , the carrying amount of the note receivable has been reduced by the Company’s
allocated share of Melt’s losses based on its ownership of total debt owed by Melt (see Note 2).
NOTE
6. 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, 2023, the Company owned 3,500,000 shares of Surface common stock. Perry J. Sternberg, a director of the Company, is a director
of Surface. Mark L. Baum, who is the Company’s Chief Executive Officer, was previously a member of the Surface board of directors
and resigned from his position as a director of Surface on March 31, 2023.
The
unaudited condensed results of operations information of Surface is summarized below:
SUMMARY
OF CONDENSED INCOME STATEMENT
2023
2022
For
the Six Months Ended
June 30,
2023
2022
Revenues, net
$ -
$ -
Loss from operations
$ ( 3,289,000 )
$ ( 3,553,000 )
Net loss
$ ( 3,144,000 )
$ ( 3,526,000 )
16
The
unaudited condensed balance sheet information of Surface is summarized below:
SUMMARY
OF CONDENSED BALANCE SHEET
At June 30,
At December 31,
2023
2022
Current assets
$ 12,182,000
$ 15,350,000
Non-current assets
808,000
652,000
Total assets
$ 12,990,000
$ 16,002,000
Total liabilities
$ 1,254,000
$ 1,586,000
Total preferred stock and stockholders’ equity
11,736,000
14,416,000
Total liabilities and stockholders’ equity
$ 12,990,000
$ 16,002,000
NOTE
7. INVENTORIES
Inventories
are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, branded commercial pharmaceutical
products, including those held at a 3PL, related laboratory supplies and active pharmaceutical ingredients. The composition of inventories
as of June 30, 2023 and December 31, 2022 was as follows:
SCHEDULE
OF INVENTORIES
June 30, 2023
December 31, 2022
Raw materials
$ 5,235,000
$ 3,707,000
Work in progress
60,000
38,000
Finished goods
3,260,000
2,796,000
Total inventories
$ 8,555,000
$ 6,541,000
NOTE
8. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets at June 30, 2023 and December 31, 2022 consisted of the following:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
June 30, 2023
December 31, 2022
Prepaid insurance
$ 276,000
$ 858,000
Prepaid computer software licenses and related expenses
1,132,000
1,165,000
Due from Melt Pharmaceuticals
728,000
139,000
Other prepaid expenses
1,249,000
1,331,000
Deposits and other current assets
427,000
118,000
Total prepaid expenses and other current assets
$ 3,812,000
$ 3,611,000
NOTE
9. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment at June 30, 2023 and December 31, 2022 consisted of the following:
SCHEDULE
OF PROPERTY, PLANT AND EQUIPMENT
June 30, 2023
December 31, 2022
Property, plant and equipment, net:
Computer hardware
$ 1,139,000
$ 979,000
Furniture and equipment
888,000
860,000
Lab and pharmacy equipment
4,499,000
4,259,000
Leasehold improvements
6,622,000
6,449,000
Property, plant and equipment,
gross
13,148,000
12,547,000
Accumulated depreciation
( 9,515,000 )
( 9,061,000 )
Property,
plant and equipment, net
$ 3,633,000
$ 3,486,000
For
the three and six months ended June 30, 2023, depreciation related to the property, plant and equipment was $ 228,000 and $ 453,000 , respectively,
compared to $ 381,000 and $ 757,000 during the same periods in 2022, respectively.
17
NOTE
10. CAPITALIZED SOFTWARE COSTS
Capitalized
software costs at June 30, 2023 and December 31, 2022 consisted of the following:
SCHEDULE
OF FINITE LIVED INTANGIBLE ASSETS
June 30, 2023
December 31, 2022
Capitalized software costs
Capitalized internal-use software development costs
$ 2,661,000
$ 1,413,000
Acquired third-party software license for internal-use
159,000
159,000
Total gross capitalized software for internal-use
2,820,000
1,572,000
Accumulated amortization
( 1,029,000 )
( 793,000 )
Capitalized internal-use software in process
345,000
1,333,000
Total finite lived intangible
assets net
$ 2,136,000
$ 2,112,000
The
Company recorded amortization expense of $ 170,000 and $ 237,000 related to capitalized software costs during the three and six months
ended June 30, 2023, respectively, and $ 43,000 and $ 86,000 during the same periods in 2022, respectively.
NOTE
11. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at June 30, 2023 consisted of the following:
SCHEDULE
OF INTANGIBLE ASSETS
Amortization
Periods
(in years)
Cost
Accumulated
Amortization
Impairment
Net
Carrying Value
Patents
17 - 19
$ 980,000
$ ( 204,000 )
$ -
$ 776,000
Licenses
20
100,000
( 28,000 )
-
72,000
Trademarks
Indefinite
267,000
-
-
267,000
Acquired NDAs
10 - 15
155,193,000
( 6,338,000 )
-
148,855,000
Customer relationships
3 - 15
596,000
( 489,000 )
-
107,000
Trade name
5
75,000
( 5,000 )
-
70,000
Non-competition clause
3 - 4
50,000
( 50,000 )
-
-
State pharmacy licenses
25
8,000
( 7,000 )
-
1,000
$ 157,269,000
$ ( 7,121,000 )
$ -
$ 150,148,000
Amortization
expense for intangible assets for the three and six months ended June 30, 2023 and 2022 was as follows:
SCHEDULE
OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
2023
2022
2023
2022
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2023
2022
2023
2022
Patents
$ 21,000
$ 21,000
$ 43,000
$ 43,000
Licenses
3,000
3,000
5,000
11,000
Acquired NDAs
2,805,000
341,000
4,975,000
682,000
Customer relationships
14,000
33,000
27,000
66,000
Amortization of intangible
assets
$ 2,843,000
$ 398,000
$ 5,050,000
$ 802,000
Estimated
future amortization expense for the Company’s intangible assets at June 30, 2023 is as follows:
SCHEDULE
OF ESTIMATED FUTURE AMORTIZATION EXPENSE
Remainder of 2023
$ 5,852,000
2024
11,785,000
2025
11,785,000
2026
11,785,000
2027
11,785,000
Thereafter
96,889,000
Intangible assets
$ 149,881,000
There
were no changes to the carrying value of the Company’s goodwill during the three and six months ended June 30, 2023 and 2022.
18
NOTE
12. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses at June 30, 2023 and December 31, 2022 consisted of the following:
SCHEDULE
OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
June 30,
December 31,
2023
2022
Accounts payable
$ 10,506,000
$ 6,440,000
Accrued insurance premium
10,000
575,000
Accrued IHEEZO milestone payments
5,000,000
5,000,000
Accrued litigation settlements
49,000
49,000
Accrued RPC transition payments (see Note 4)
106,000
453,000
Accrued interest (see Note 13)
2,151,000
1,254,000
Accrued exit fee for note payable (see Note 13)
2,275,000
-
Total accounts payable and accrued expenses
$ 20,097,000
$ 13,771,000
Less: Current portion
( 17,822,000 )
( 13,771,000 )
Non-current total accrued expenses
$ 2,275,000
$ -
The
Company financed all insurance policies for the policy term of August 17, 2022 through August 16, 2023. The financing agreement has an
interest rate of 4.13 % per annum and requires eight monthly payments of $ 114,000 .
NOTE
13. DEBT
Oaktree
Loan
In
March 2023, the Company entered into a Credit Agreement and Guaranty (the “Oaktree Loan”) with Oaktree Fund Administration,
LLC, as administrative agent for the lenders (together, “Oaktree”), providing for a senior secured term loan facility to
the Company with a principal amount of up to $ 100,000,000 . Upon entering into the Oaktree Loan, the Company drew a principal amount of
$ 65,000,000 (“Tranche A”) from the Oaktree Loan and used the net proceeds to repay all amounts owed by the Company pursuant
to the Loan and Security Agreement the Company previously entered into with B. Riley Commercial Capital, LLC on December 14, 2022 (the
“B. Riley Loan”) – see subheading B. Riley Loan and Security Agreement – Paid in Full within this footnote.
The additional principal loan amount of up to $ 35,000,000 available under the Oaktree Loan (“Tranche B”) will be made available
to the Company upon the commercialization of TRIESENCE. If Tranche B is not drawn by the Company on or before March 27, 2024, the amount
available under Tranche B decreases to $ 30,000,000 .
The
Oaktree Loan is secured by nearly all of the assets, including intellectual property, of the Company and its material subsidiaries. The
Oaktree Loan has a maturity date of January 19, 2026 and carries an interest rate equal to the Secured Overnight Financing Rate (SOFR)
plus 6.5 % per annum (totaling 11.77 % at June 30, 2023). From proceeds, the Company paid fees, offering expenses, and the Oaktree Loan
was issued at an original issue discount of $ 3,415,000 , in aggregate. The Oaktree Loan also carries an exit fee equal to 3.50 % of the
aggregate principal amount owed and the Company accrued $ 2,275,000 related to the exit fee. The original issue discount, fees and expenses
(including the exit fee) are being amortized over the term of the Oaktree Loan using the effective interest rate method. The Oaktree
Loan requires quarterly interest-only payments with all of the unpaid principal, interest and fees due on the maturity date, January
19, 2026.
The
Oaktree Loan contains customary guarantees and covenants, including financial covenants related to minimum liquidity and minimum net
revenues. As of the end of the fiscal quarter ending December 31, 2024, if the Company’s Total Leverage Ratio (as defined in the
Oaktree Loan) is greater than or equal to five times, but less than seven times, the Company will be required to issue to Oaktree warrants
to purchase 375,000 shares of the Company’s common stock, and if the Total Leverage Ratio is greater than or equal to seven times,
the Company will be required to issue to Oaktree warrants to purchase an additional 375,000 shares of the Company’s common stock
(equaling 750,000 shares in aggregate). If the Total Leverage Ratio as of the end of the fiscal quarter ending December 31, 2024 is less
than five times, no warrants will be issued to Oaktree. Based on current projections, the Company does not expect to issue any warrants
related to the Oaktree Loan.
19
Interest
expense related to the Oaktree Loan totaled $ 2,570,000 and $ 2,665,000 for the three and six months ended June 30, 2023, respectively,
and included the amortization of debt issuance costs and discount of $ 514,000 and $ 526,000 , respectively.
See
Note 18 for additional information and an amendment made to the Oaktree Loan subsequent to June 30, 2023.
HROWM
- 11.875% Senior Notes Due 2027
In
December 2022 and in January 2023, the Company closed an offering of $ 35,000,000 and $ 5,250,000 , respectively, aggregate principal amount
of 11.875 % senior notes due in December 2027 (the “2027 Notes”). The 2027 Notes were sold to investors at a par value of
$ 25.00 per 2027 Note, and the offering resulted in net proceeds to the Company of approximately $ 36,699,000 after deducting underwriting
discounts and commissions and expenses of $ 3,551,000 .
The
2027 Notes are senior unsecured obligations of the Company and rank equally in right of payment with all of the Company’s other
existing and future senior unsecured and unsubordinated indebtedness. The 2027 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 2027 Notes bear interest at the rate of 11.875 % per annum. Interest
on the 2027 Notes is payable quarterly in arrears on January 31, April 30, July 31 and October 31 of each year, commencing on January
31, 2023. The 2027 Notes will mature on December 31, 2027 .
At
any time prior to December 31, 2024, the Company may, at its option, redeem the 2027 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 2027 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 2027 Notes for cash in whole or
in part at any time at its option (i) on or after December 31, 2024 and prior to December 31, 2025, at a price equal to $25.50 per note,
plus accrued and unpaid interest to, but excluding, the date of redemption, (ii) on or after December 31, 2025 and prior to December
31, 2026, at a price equal to $25.25 per note, plus accrued and unpaid interest to, but excluding, the date of redemption, and (iii)
on or after December 31, 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. In addition, the Company is required to redeem the 2027 Notes, for cash, in whole but not
in part, at the price of $25.50 per note , plus accrued and unpaid interest to, but excluding, the date of redemption, upon occurrence
of certain events including the occurrence of a Material Change, as defined in the Second Supplemental Indenture. The 2027 Notes trade
on the Nasdaq Stock Market LLC under the symbol “HROWM.”
Interest
expense related to the 2027 Notes totaled $ 1,371,000 and $ 2,766,000 for the three and six months ended June 30, 2023, respectively, and
included amortization of debt issuance costs and debt discount of $ 176,000 and $ 376,000 , respectively.
Our
Chief Executive Officer, Mark L. Baum, Chief Financial Officer, Andrew R. Boll along with director R. Lawrence Van Horn and former director
Dr. Richard Lindstrom, in the aggregate, own $ 950,000 in principal amount of the 2027 Notes.
HROWL
- 8.625% Senior Notes Due 2026
In
April 2021, the Company closed an offering of $ 50,000,000 aggregate principal amount of 8.625% senior notes due April 2026, and in May
2021 issued an additional $ 5,000,000 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 $ 51,909,000 after deducting underwriting discounts and commissions
and expenses of $ 3,091,000 . In June 2021, in a further issuance of the April Notes, the Company sold an additional $ 20,000,000 aggregate
principal amount of such notes (the “June Notes,” and together with the April Notes, the “2026 Notes”), at a
price of $ 25.75 per June Note, with interest of $ 278,000 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 $ 19,164,000 after deducting underwriting discounts and commissions
and expenses of $ 1,158,000 and a premium on note issuance of $ 322,000 . 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). The 2026 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 2026 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 2026 Notes bear interest at a rate of 8.625 %
per annum. Interest on the 2026 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 2026 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 2026 Notes using the effective interest
rate method.
20
Prior
to February 1, 2026, the Company may, at its option, redeem the 2026 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 2026 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 2026 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.
The 2026 Notes trade on the Nasdaq Stock Market LLC under the symbol “HROWL”.
Interest
expense related to the 2026 Notes totaled $ 1,812,000 and $ 3,622,000 and $ 1,812,000 and $ 3,622,000 for the three and six months ended
June 30, 2023 and 2022, respectively, and included amortization of debt issuance costs and discount of $ 195,000 and $ 388,000 and $ 195,000
and $ 388,000 for three and six months ended June 30, 2023 and 2022, respectively.
B. Riley Loan and Security Agreement – Paid in Full
On
December 14, 2022 (the “Effective Date”), the Company entered into a Loan and Security Agreement (the “BR Loan”)
with B. Riley Commercial Capital, LLC, as Administrative Agent for the Lenders. The BR Loan provided for a loan facility of up to $ 100,000,000
to the Company with a maturity date of December 14, 2025 (the “Maturity Date”), at an interest rate of 10.875 % per annum.
The
BR Loan was secured by an intellectual property security agreement entered into in connection with the BR Loan, and by all assets of
the Company and its material subsidiaries. The outstanding balance of the BR Loan was due in full on the Maturity Date. The BR Loan provided
for voluntary prepayment subject to no prepayment fee if no loan amount had been funded or the prepayment or repayment occurred (other
than as a result of acceleration of the BR Loan) on or prior to the date that was 90 days following the Effective Date and up to 3.00 %
of the amount of the BR Loan based on other payment dates.
In
January 2023, $ 59,750,000 of principal amount was funded pursuant to the BR Loan simultaneously with the consummation of the Fab 5 Acquisition
(see Note 4). In March 2023, the Company repaid all amounts owed under the BR Loan, in connection with the Oaktree Loan, and no exit
or prepayment fees were paid as a result of the payoff of the BR Loan pursuant to a side letter agreement among the parties.
Interest
expense related to the BR Loan totaled $ 1,565,000 for the six months ended June 30, 2023, and included amortization of debt issuance
costs and debt discount of $ 356,000 . The Company recorded a loss of $ 5,465,000 related to the early extinguishment of debt associated
with the BR Loan.
A
summary of the Company’s debt is described as follows:
SCHEDULE
OF LONG TERM DEBT
June 30,
December 31,
2023
2022
8.625% Senior Notes due April 2026
$ 75,000,000
$ 75,000,000
11.875% Senior Notes due December 2027
40,250,000
35,000,000
Oaktree Loan due January 2026
65,000,000
-
Notes payable gross
180,250,000
110,000,000
Less: Unamortized debt issuance costs
( 10,538,000 )
( 5,826,000 )
Notes payable net
$ 169,712,000
$ 104,174,000
For
the three and six months ended June 30, 2023 the total effective interest rate of the Company’s debt was 10.71 %, and 10.81 %, respectively,
and 8.88 % and 8.94 % for the same periods in the prior year, respectively.
21
At
June 30, 2023, future minimum payments under the Company’s debt were as follows:
SCHEDULE
OF FUTURE MINIMUM PAYMENT UNDER NOTES PAYABLES
Amount
Remainder of 2023
$ 9,815,000
2024
19,352,000
2025
18,748,000
2026
147,305,000
2027
45,030,000
Total minimum payments
240,250,000
Less: amount representing interest payments
( 60,000,000 )
Notes payable, gross principal amount due
180,250,000
Less: unamortized debt issuance costs, net of premium
( 10,538,000 )
Notes payable, net of unamortized discount
$ 169,712,000
NOTE
14. LEASES
The
Company leases office and laboratory space under non-cancelable operating leases listed below. These lease agreements have remaining
terms between one to five years and contain various clauses for renewal at the Company’s option.
● An
operating lease for 5,789 square feet of office space in Carlsbad, California, which commenced
in January 2022 and will expire in March 2025 .
● An
operating lease for 35,326 square feet of lab, warehouse and office space in Ledgewood, New
Jersey that expires in July 2027 , with an option to extend the term for two additional five-year
periods. This includes an amendment, which 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 added 8,900 square feet of space.
● An
operating lease for 5,500 square feet of office space in Nashville, Tennessee, which commended
in January 2020 and will expire in December 2024 , with an option to extend the term for two
additional five-year periods.
● An
operating lease for 11,552 square feet of lab and office space in Nashville, Tennessee which
commenced in June 2022 and will expire in June 2027 .
At
June 30, 2023, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases
held by the Company were 6.61 % and 10.59 years, respectively.
During
the three and six months ended June 30, 2023, cash paid for amounts included for the operating lease liabilities was $ 306,000 and $ 611,000 ,
respectively, and $ 207,000 and $ 373,000 during the same periods in 2022, respectively. During the three and six months ended June 30,
2023 and 2022, the Company recorded operating lease expense of $ 308,000 and $ 617,000 and $ 262,000 and $ 500,000 , respectively, which is
included in selling, general and administrative expenses.
22
Future
lease payments under operating leases as of June 30, 2023 were as follows :
SCHEDULE
OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES
Operating Leases
Remainder of 2023
$ 619,000
2024
1,262,000
2025
1,093,000
2026
1,114,000
2027
972,000
Thereafter
5,829,000
Total minimum lease payments
10,889,000
Less: amount representing interest payments
( 3,186,000 )
Total operating lease obligations
7,703,000
Less: current portion, operating lease obligations
( 764,000 )
Operating lease obligations, net of current portion
$ 6,939,000
NOTE
15. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Common
Stock
During
the six months ended June 30, 2023, the Company issued 131,760 shares of its common stock underlying RSUs held by a director that ceased
providing services to the Company. The RSUs had previously vested, including 13,123 RSUs during the six months ended June 30, 2023, but
the issuance and delivery of the shares were deferred until the director terminated all service to the Company.
During
the six months ended June 30, 2023, the Company issued 59,504 shares of common stock and received proceeds of $ 337,000 upon the exercise
of options to purchase 59,504 shares of common stock with exercise prices ranging from $ 1.70 to $ 8.50 per share.
During
the six months ended June 30, 2023, the Company issued 62,367 shares of common stock to Mark L. Baum, the Company’s Chief Executive
Officer, upon the cashless exercise of options to purchase 180,000 shares at an exercise price of $ 8.99 per share. The Company withheld
from Mr. Baum 77,167 shares as consideration for the cashless exercise and an additional 40,466 shares for payroll tax obligations totaling
$ 849,000 .
During
the six months ended June 30, 2023, the Company issued 55,558 shares of common stock to Andrew R. Boll, the Company’s Chief Financial
Officer, upon the cashless exercise of options to purchase 90,000 shares at an exercise price of $ 6.00 per share. The Company withheld
from Mr. Boll 25,521 shares as consideration for the cashless exercise and an additional 8,921 shares for payroll tax obligations totaling
$ 189,000 .
During
the six months ended June 30, 2023, upon vesting of 23,000 RSUs granted in January 2020 to Andrew R. Boll, the Company’s Chief
Financial Officer, the Company issued 13,398 shares of common stock to Mr. Boll, net of 9,602 shares of common stock withheld for payroll
tax withholdings totaling $ 142,000 .
During
the six months ended June 30, 2023, upon vesting of 88,000 RSUs granted in January 2020 to Mark L. Baum, the Company’s Chief Executive
Officer, the Company issued 52,821 shares of common stock to Mr. Baum, net of 35,179 shares of common stock withheld for payroll tax
withholdings totaling $ 519,000 .
During
the six months ended June 30, 2023, 32,810 shares of the Company’s common stock underlying RSUs issued to directors vested, but
the issuance and delivery of these shares are deferred until the applicable director ceased providing services to the Company.
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, 2023, the 2017 Plan provides for the issuance of a maximum of 6,000,000
shares of the Company’s common stock. The purposes 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 IRC of 1986, as amended, non-qualified stock options, restricted stock units, performance
stock units and restricted stock. The Plans are administered by the Compensation Committee of the Company’s Board of Directors.
The Company had 529,117 shares available for future issuances under the 2017 Plan at June 30, 2023.
23
Stock
Options
A
summary of stock option activity under the Plans for the six months ended June 30, 2023 is as follows:
SCHEDULE
OF STOCK OPTION PLAN ACTIVITY
Number of Shares
Weighted Average Exercise Price
Weighted Average Remaining Contractual Life
Aggregate Intrinsic Value
Options outstanding – January 1, 2023
3,027,701
$ 5.90
Options granted
47,000
$ 19.69
Options exercised
( 329,504 )
$ 7.55
Options cancelled/forfeited
( 66,299 )
$ 6.32
Options outstanding – June 30, 2023
2,678,898
$ 5.93
4.34
$ 35,200,000
Options exercisable
2,416,383
$ 5.50
3.85
$ 32,729,000
Options vested and expected to vest
2,642,748
$ 5.86
4.28
$ 34,882,000
The
aggregate intrinsic value in the table above represents the total pre-tax amount of the proceeds, net of exercise price, which would
have been received by option holders if all option holders had exercised and immediately sold all shares underlying options with an exercise
price lower than the market price on June 30, 2023, based on the closing price of the Company’s common stock of $ 19.04 on that
date.
During
the six months ended June 30, 2023, the Company granted stock options to certain employees. 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 ten years. Vesting terms for options granted to employees during
the six months ended June 30, 2023 included the following vesting schedule: 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
2023
2022
Weighted-average fair value of options granted
$ 12.72
$ 4.54
Expected terms (in years)
5.50 - 6.11
6.11
Expected volatility
69 - 70 %
68 - 70 %
Risk-free interest rate
3.64 - 3.94 %
1.54 - 2.78 %
Dividend yield
-
-
24
The
following table summarizes information about stock options outstanding and exercisable at June 30, 2023:
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 - $ 1.73
295,852
4.46
$ 1.72
295,852
$ 1.72
$ 2.23
285,000
3.59
$ 2.23
285,000
$ 2.23
$ 2.40 - $ 2.60
24,068
3.52
$ 2.58
24,068
$ 2.58
$ 3.95
310,000
2.75
$ 3.95
310,000
$ 3.95
$ 4.08 - $ 5.72
123,225
4.92
$ 5.28
113,541
$ 5.24
$ 6.30
285,000
5.64
$ 6.30
285,000
$ 6.30
$ 6.75 - $ 7.26
106,625
8.58
$ 6.96
20,875
$ 7.01
$ 7.30
274,500
6.51
$ 7.30
274,500
$ 7.30
$ 7.37 - $ 7.79
246,455
4.75
$ 7.53
167,185
$ 7.50
$ 7.87 - $ 25.86
728,173
3.12
$ 8.80
640,362
$ 7.89
$ 1.47 - $ 25.86
2,678,898
4.34
$ 5.93
2,416,383
$ 5.50
As
of June 30, 2023, there was approximately $ 1,464,000 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 2.85 years. The stock-based
compensation for all stock options was $ 122,000 and $ 463,000 during the three and six months ended June 30, 2023, respectively, and $ 258,000
and $ 530,000 during the same periods in 2022, respectively.
The
intrinsic value of options exercised during the six months ended June 30, 2023 was $ 4,377,000 .
Restricted
Stock Units
RSU
awards are granted subject to certain vesting requirements and other restrictions, including time-based 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, 2023, the Company’s board of directors were granted 41,301 time-vesting RSUs with a fair market value
of $ 800,000 , which vest in equal quarterly installments over one year.
Performance
Stock Units
In
April 2023, the Company granted an aggregate of 1,567,913 PSUs to members of its senior management including Mark Baum, Chief Executive
Officer, Andrew Boll, Chief Financial Officer, and John Saharek, Chief Commercial Officer, which are subject to the satisfaction of certain
market-based and continued service conditions (the “2023 PSUs”). The vesting of the 2023 PSUs require (i) a minimum of a
two-year service period, and (ii) during a five-year term, the achievement and maintenance of Company common stock price targets ranging
between $ 25 to $ 50 , broken out into four separate tranches as described further in the table below.
SCHEDULE
OF PERFORMANCE STOCK UNITS
Tranche
Number of Shares
Target Share Price*
Tranche 1
223,988
$ 25
Tranche 2
335,981
$ 35
Tranche 3
447,975
$ 45
Tranche 4
559,969
$ 50
* Target Share Price assumes
that no dividends or like distributions are made to stockholders of the Company. If such distributions are made, the Target Share
Price would decrease accordingly, to the benefit of the employee, to account for the dividend/distribution as a part of the Target
Share Price.
25
The
aggregate fair value of the 2023 PSUs was $ 29,106,000 using a Monte Carlo Simulation with a five-year life, 65 % volatility and a risk
free interest rate of 10.34 %. This amount is being amortized over a two-year derived service period.
A
summary of the Company’s RSU and PSU activity and related information for the six months ended June 30, 2023 is as follows:
SCHEDULE
OF RESTRICTED STOCK UNITS AND PERFORMANCE STOCK UNITS ACTIVITY
Number of Shares
Weighted Average Grant Date Fair Value
RSUs and PSUs unvested - January 1, 2023
2,061,719
$ 6.88
RSUs granted
54,424
$ 16.54
PSUs granted
1,567,913
$ 18.56
RSUs vested
( 156,928 )
$ 7.39
RSUs cancelled/forfeited
( 75,000 )
$ 5.83
RSUs and PSUs unvested - June 30, 2023
3,452,128
$ 12.28
As
of June 30, 2023, the total unrecognized compensation expense related to unvested RSUs and unvested PSUs was approximately $ 27,192,000 ,
which is expected to be recognized over a weighted-average period of 0.89 years, based on estimated and actual vesting schedules of the
applicable RSUs and PSUs. The stock-based compensation for RSUs and PSUs during the three and six months ended June 30, 2023 was $ 5,290,000
and $ 6,582,000 , respectively, and $ 1,735,000 and $ 3,479,000 during the same periods in 2022, 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
June 30, 2023
June 30, 2022
June 30, 2023
June 30, 2022
For the Three Months Ended
For the Six Months Ended
June 30, 2023
June 30, 2022
June 30, 2023
June 30, 2022
Employees - selling, general and administrative
$ 4,607,000
$ 1,655,000
$ 5,935,000
$ 3,331,000
Employees – research and development
586,000
176,000
749,000
362,000
Directors - selling, general and administrative
203,000
112,000
328,000
212,000
Consultants - selling, general and administrative
16,000
50,000
33,000
104,000
Total
$ 5,412,000
$ 1,993,000
$ 7,045,000
$ 4,009,000
NOTE
16. COMMITMENTS AND CONTINGENCIES
Legal
General
and Other
In
the ordinary course of business, the Company is involved in various legal proceedings, government investigations and other matters that
are complex in nature and have outcomes that are difficult to predict. The Company describes legal proceedings and other matters that
are/were significant or that it believes could become significant in this footnote.
The
Company records accruals for loss contingencies to the extent that it concludes it is probable that a liability has been incurred and
the amount of the related loss can be reasonably estimated. The Company evaluates, on a quarterly basis, developments in legal proceedings
and other matters that could cause an increase or decrease in the amount of a liability that has been accrued previously.
26
The
Company’s legal proceedings involve various aspects of its business and a variety of claims, some of which present novel factual
allegations and/or unique legal theories. Typically, a number of the matters pending against the Company are at early stages of the legal
process, which in complex proceedings of the sort the Company face often extend for several years. While it is not possible to accurately
predict or determine the eventual outcomes of matters that have not concluded, an adverse determination in one or more of the matters
(whether discussed in this footnote or not) currently pending may have a material adverse effect on the Company’s condensed consolidated
results of operations, financial position or cash flows.
Ocular
Science, Inc. et. al
In
July 2021, ImprimisRx, LLC, a subsidiary of the Company, filed a lawsuit against Ocular Science, Inc. and OSRX, Inc. (together, “OSRX”)
in the U.S. District Court for the Southern District of California, asserting claims for copyright infringement, trademark infringement,
unfair competition and false advertising (Lanham Act). ImprimisRx is seeking damages from OSRX. Since July 2021, the complaint has been
amended and OSRX added counterclaims alleging ImprimisRx, LLC is violating the Lanham Act with false advertising. Both parties are seeking
damages from the other. Trial is set to take place in the fourth quarter of 2023.
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.
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 indemnifies Oaktree for
certain claims and losses associated with the Oaktree Loan. The Company also indemnifies its lessors in connection with its facility
leases for certain claims arising from the use of the facilities. These indemnities do not provide for any limitation of the maximum
potential future payments the Company could be obligated to make. Historically, the Company has not incurred any payments for these obligations
and, therefore, no liabilities have been recorded for these indemnities in the accompanying condensed consolidated balance sheets.
Klarity
License Agreement – Related Party
The
Company entered into a license agreement in April 2017, as amended in April 2018 (the “Klarity License Agreement”), with
Richard L. Lindstrom, M.D., a former 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% to 6% of
net sales, dependent upon the final formulation of the Klarity Product sold. In addition, the Company is required to make certain milestone
payments to Dr. Lindstrom including: (i) an initial payment of $ 50,000 upon execution of the Klarity License Agreement, (ii) a second
payment of $ 50,000 following the first $ 50,000 in net sales of the Klarity Product; and (iii) a final payment of $ 50,000 following the
first $ 100,000 in net sales of the Klarity Product. All of the above referenced milestone payments were payable at the Company’s
election in cash or shares of the Company’s restricted common stock. Payments totaling $ 75,000 and $ 146,000 were made during the
three and six months ended June 30, 2023, respectively, compared to $ 92,000 and $ 122,000 during the same periods in 2022, respectively.
Royalty expenses were $ 74,000 and $ 149,000 during the three and six months ended June 30, 2023, respectively, compared to $ 106,000 and
$ 177,000 during the same periods in 2022, respectively, and were included in accounts payable to Dr. Lindstrom.
27
Injectable
Asset Purchase Agreement – Related Party
In
December 2019, the Company entered into an asset purchase agreement (the “Lindstrom APA”) with Dr. Lindstrom, a former 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 $ 33,000 upon execution of the Lindstrom APA. Dr. Lindstrom
was paid $ 8,000 and $ 17,000 in cash during the three and six months ended June 30, 2023, respectively, and $ 7,000 and $ 15,000 during
the same periods in 2022, respectively. The Company incurred $ 9,000 and $ 17,000 for royalty expenses related to the Lindstrom APA during
the three and six months ended June 30, 2023, respectively, and $ 8,000 and $ 15,000 during the same periods in 2022, respectively.
Other
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. During the three and six months ended June 30, 2023, $ 192,000 and $ 485,000 were incurred under these agreements as royalty
expenses, respectively, and $ 297,000 and $ 510,000 during the same periods in 2022, respectively.
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
(“IHEEZO”) in the U.S. and Canada.
28
Pursuant
to the Sintetica Agreement, the Company agreed to pay Sintetica a per unit transfer price to supply IHEEZO, along with a per unit royalty
for units sold. The Company is required to pay Sintetica up to $ 18,000,000 in one-time milestone payments including a $ 5,000,000 payment
(the “Upfront Payment”) due within 30 days of signing the Sintetica Agreement and the balance of payments due upon achievement
of certain regulatory and commercial milestones. Under the terms of the Sintetica Agreement, Sintetica was responsible for regulatory
filings for IHEEZO in the U.S. As of June 30, 2023 and December 31, 2022, the Company had accrued $ 5,000,000 under the Sintetica Agreement
related to a milestone payment, which was capitalized as an intangible asset.
Subject
to certain limitations, the Sintetica Agreement has a ten-year term, and allows for a ten-year extension if certain sales thresholds
are met.
Wakamoto
Agreement
In
August 2021, the Company entered into a License Agreement and a Basic Sale and Purchase Agreement (together, the “Wakamoto Agreements”)
with Wakamoto Pharmaceutical Co., Ltd. (“Wakamoto”), pursuant to which Wakamoto granted the Company the exclusive license
and marketing rights to its ophthalmic drug candidate (“MAQ-100”) in the U.S. and Canada.
Pursuant
to the Wakamoto Agreements, Wakamoto will supply MAQ-100 to the Company, and the Company will pay Wakamoto a per unit transfer price
to supply MAQ-100. In addition, the Company is required to pay Wakamoto various one-time milestone payments totaling up to $ 2,000,000
upon the achievement of certain regulatory milestones and up to $ 6,200,000 upon the achievement of certain commercial milestones. Under
the terms of the Agreements, the Company will be responsible for regulatory filings and fees for MAQ-100 in the U.S. and Canada. Through
June 30, 2023, no amounts have been paid or accrued under the Wakamoto Agreements.
Subject
to certain limitations, the term of the Wakamoto Agreements is for five years from the date of the FDA’s market approval of MAQ-100
and allows for a five-year extension if certain unit sales thresholds are met.
Eyepoint
Commercial Alliance Agreement - Terminated
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 pays 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 agreed to use commercially reasonable efforts to promote and market DEXYCU in the U.S.
Pursuant
to a mutual termination agreement entered into on October 7, 2022, the Dexycu Agreement terminated on January 1, 2023. Following the
preliminary Hospital Outpatient Prospective Payment System (HOPPS) rule proposed by the Centers for Medicare & Medicaid Services
(CMS) in July of 2022, which did not contain an extension of the pass-through payment period for Dexycu beyond December 31, 2022, the
Company entered into a Mutual Termination Agreement (the “Termination Agreement”) with Eyepoint on October 7, 2022, pursuant
to which Eyepoint and the Company agreed (a) that the Company will continue to support the sale of Dexycu through the fourth quarter
of 2022, consistent with the Company’s level of effort during the January through June 2022 period, (b) to decrease the required
minimum quarterly sales levels based on Dexycu unit demand for the fourth quarter of 2022, and (c) to terminate the Dexycu Agreement,
along with ancillary letter agreements, effective January 1, 2023.
During
the three and six months ended June 30, 2022, the Company recorded $ 1,212,000 and $ 2,532,000 , 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.
29
Under
the terms of the sales and marketing agreements, the Company is generally required to make commission payments equal to 10% to 14% of
net sales for products above and beyond the initial existing sales amounts. In addition, the Company is required to 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 $ 0 and $ 130,000 were incurred under these agreements
for commission expenses during the three and six months ended June 30, 2023, respectively, and $ 1,100,000 and $ 2,147,000 during the same
periods in 2022, respectively.
NOTE
17. SEGMENTS AND CONCENTRATIONS
The
Company operates its business on the basis of a single reportable segment, which is the business of discovery, development, and commercialization
of innovative ophthalmic therapies. The Company’s chief operating decision-maker is the Chief Executive Officer, who evaluates
the Company as a single operating segment.
The
Company has four products that each accounted for more than 10% of total revenues during the three months ended June 30, 2023 and three
products that each accounted for more that 10% of total revenues during the six months ended June 30, 2023. The Company had two products
that each accounted for more than 10% of total revenues during the three and six months ended June 30, 2022. These products collectively
accounted for 48 %
and 38 %
of revenues during the three and six months ended June 30, 2023, respectively, and 32 %
and 32 %
during the same periods in 2022, respectively.
As
of June 30, 2023 and December 31, 2022, accounts receivable from a single customer accounted for 49 % and 0 % of total accounts receivable,
respectively. For the three and six months ended June 30, 2023, revenues from a single customer accounted for 27 % and 16 % of total revenues,
respectively. For the three and six months ended June 30, 2022 no customer exceeded 10% of total revenues.
The Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively
accounted for 80 % and 85 % of active pharmaceutical ingredient purchases during the three and six months ended June 30, 2023,
respectively, and 72 % and 73 % during the same periods in 2022, respectively.
NOTE
18. SUBSEQUENT EVENTS
The
Company has performed an evaluation of events occurring subsequent to June 30, 2023 through the filing date of this Quarterly Report.
Based on its evaluation, no events other than those described below need to be disclosed.
In
August 2023, the Company issued 63 shares of common stock and received proceeds of $ 1,000 upon the exercise of options to purchase 63
shares of common stock with exercise price of $ 6.85 per share.
Settlement
of Performance Stock Units
Effective
as of July 18, 2023, the Company settled 1,567,913 outstanding PSUs as a result of the achievement of the total stockholder returns (“TSR”)
targets set forth in equity incentive awards previously issued to members of the Company’s management team in 2021 (the “2021
Awards”). The 2021 Awards were separated into four tranches and required that the Company achieve and maintain certain levels of
TSR ranging from 50 % to 175 % per share during the five-year period following the grant date. TSR was based on the aggregate of: (i) the
percent increase of the closing price of the Company’s common stock from July 22, 2021; and (ii) any dividends or like stockholder
distributions as specified in the PSU agreements. In connection with the settlement of the 2021 Awards, an aggregate of 616,984 shares
of the Company’s common stock were withheld by Harrow for payroll tax obligations totaling $ 11,272,000 .
Acquisition
of VEVYE TM U.S. and Canadian Commercial Rights
In
July 2023, the Company acquired commercial rights of VEVYE (cyclosporine ophthalmic solution) 0.1%, an ophthalmic drug product, for
the U.S. and Canadian markets (the “VEVYE Acquisition”). The Company acquired the commercial rights to VEVYE by entering
into a license agreement with Novaliq GmbH (“Novaliq”). As consideration, the Company has made initial payments to
Novaliq totaling $ 8,000,000
and will pay low double-digit royalties on net sales of VEVYE along with potential commercial milestone payments.
Acquisition
of Certain U.S. and Canadian Commercial Rights to Santen and Eyevance Products
In
July 2023, the Company entered into an Asset Purchase Agreement with Eyevance Pharmaceuticals, LLC and a License Agreement with Santen
S.A.S. (collectively, the “Santen Agreements”), each a subsidiary of Santen Pharmaceuticals Co., Ltd. (collectively, “Santen”).
Pursuant to the Santen Agreements, the Company acquired the exclusive commercial rights to assets associated with the following ophthalmic
products (collectively, the “Santen Products”):
30
In
the U.S.:
●
FLAREX®
(fluorometholone acetate ophthalmic suspension) 0.1%, a corticosteroid prepared as a sterile topical ophthalmic suspension indicated
for use in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior
segment of the eye.
●
NATACYN®
(natamycin ophthalmic suspension) 5%, a sterile, antifungal drug for the treatment of fungal blepharitis, conjunctivitis, and keratitis
caused by susceptible organisms, including Fusarium solani keratitis.
●
TOBRADEX®
ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05%, a topical antibiotic and corticosteroid combination for steroid-responsive
inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk
of bacterial ocular infection exists.
●
ZERVIATE®
(cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated
with allergic conjunctivitis.
●
FRESHKOTE®,
a preservative-free formulation for temporary relief of symptoms of dry eye.
In
the U.S. and Canada:
●
VERKAZIA®
(cyclosporine ophthalmic emulsion) 0.1%, an orphan designated drug that is a calcineurin inhibitor immunosuppressant indicated for
the treatment of vernal keratoconjunctivitis.
In
Canada:
●
CATIONORM®
PLUS, a preservative-free formulation for dry eye or allergy relief.
The
transactions pursuant to the Santen Agreements are referred to in these footnotes as the “Santen Products Acquisition.”
Under
the terms of the Santen Agreements, the Company made an initial one-time payment of $ 8,000,000 . In addition, the agreements provide for
various one-time milestone payments associated with certain manufacturing-related events as well as low-double digit royalty payments
on net sales of Verkazia and high-single digit royalty payments on net sales of Cationorm Plus. Under the Santen Agreements, the Company
also assumed certain obligations associated with other third parties that require mid-single digit royalties on sales of Freshkote and
Zerviate. Immediately following the closing and subject to certain conditions, for a period that the Company expects to last approximately
four months, and prior to the transfer of the Santen Product NDAs and other marketing authorizations to the Company, Santen will continue
to sell the Santen Products on the Company’s behalf and transfer the net profit from the sale of the Santen Products to the Company.
Oaktree
Credit Agreement Amendment
In
July 2023, the Company entered into the First Amendment to Credit Agreement and Guaranty and Consent (the “Oaktree Amendment”)
to the Oaktree Loan (see Note 13). Under the Oaktree Amendment, the overall credit facility size was increased from $ 100,000,000 to $ 112,500,000 ,
and the Company made other changes related to the Santen Products Acquisition. Upon satisfaction of certain conditions to funding, the
Company drew down a principal amount of $ 12,500,000 (the “Loan Increase”) to fund the initial one-time payment associated
with the Santen Products Acquisition and for other working capital and general corporate purposes. No other material changes to the Oaktree
Loan were provided in the Oaktree Amendment. Following entry into the Oaktree Amendment and the funding of the Loan Increase upon closing
of the Santen Products Acquisition, the Company has drawn down a total principal loan amount of $ 77,500,000 under the Oaktree Loan and
an additional principal loan amount of up to $ 35,000,000 remains available to the Company upon the commercialization of TRIESENCE.
Common
Stock Offering
In
July 2023, the Company closed a public offering of shares of its common stock at an offering price of $ 17.75 per share (the “Offering”).
The Company sold 3,887,324 shares of its common stock in the Offering, resulting in the Company receiving aggregate gross proceeds of
$ 69,000,000 , before commissions and other offering expenses.
31
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, 2022 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 ImprimisRx, LLC,
ImprimisRx NJ, LLC dba ImprimisRx, Imprimis NJOF, LLC, and Harrow Eye, LLC. 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: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products,
product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, 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, including inflation and supply chain challenges; 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; 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
We
are a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical
products for the U.S. market. Harrow helps U.S. eyecare professionals preserve the gift of sight by making its comprehensive portfolio
of prescription and non-prescription pharmaceutical products accessible and affordable to millions of Americans each year We own commercial
rights to one of the largest portfolios of branded ophthalmic pharmaceutical products in the U.S. that are marketed under our Harrow
name. We also own and operate ImprimisRx, one of the nation’s leading ophthalmology-focused pharmaceutical-compounding businesses
In addition, we have non-controlling equity positions in Surface Ophthalmics, Inc. (“Surface”) and Melt Pharmaceuticals,
Inc. (“Melt”), both companies that began as subsidiaries of Harrow and were subsequently carved-out of our corporate structure
and deconsolidated from our financial statements. We also own royalty rights in certain drug candidates being developed by Surface and
Melt.
Factors
Affecting Our Performance
We
believe the primary factors affecting our performance are our ability to increase revenues of our branded pharmaceutical products, proprietary
compounded formulations and certain non-proprietary products, grow and gain operating efficiencies in our operations, potential regulatory-related
restrictions, optimize pricing and obtain reimbursement options for our drug products, and continue to pursue development and commercialization
opportunities for certain of our ophthalmology and other assets that we have not yet made commercially available. 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.
32
Recent
Developments
The
following describes certain developments in 2023 to date that are important to understand our financial condition and results of operations.
See the notes to our unaudited condensed consolidated financial statements included in this Quarterly Report for additional information
about each of these developments.
IHEEZO
Reimbursement and Launch
In
February 2023, we announced that the Centers for Medicare & Medicaid Services (“CMS”) had issued a permanent, product
specific J-code for IHEEZO (J2403) which became effective under the Healthcare Procedure Coding System (HCPCS) on April 1, 2023, which
physicians can use for reimbursement purposes of that product. New drugs approved by the FDA that are used in surgeries performed in
a hospital outpatient departments or ambulatory surgical centers may receive a transitional pass-through reimbursement under Medicare,
provided they meet certain criteria, including a “not insignificant” cost criterion. Pass-through status allows for separate
payment (i.e., outside the packaged payment rate for the surgical procedure) under Medicare Part B, which consists of Medicare reimbursement
for a drug based on a defined formula for calculating the minimum fee that a manufacturer may charge for the drug. Under current regulations
of CMS, pass-through status applies for a period of three years; which is measured from the date Medicare makes its first pass-through
payment for the product. Following the three-year period, the product would be incorporated into the cataract bundled payment system,
which could significantly reduce the pricing for that product. Temporary pass-through reimbursement for IHEEZO was awarded by CMS and
made effective in April 2023.
At
the beginning of April 2023, we initiated a regional and targeted launch of IHEEZO (chloroprocaine HCL ophthalmic gel) 3%. In early May
2023, our full commercial launch of IHEEZO occurred, with the product being highlighted by our commercial team at the ASCRS (American
Society of Cataract and Refractive Surgery) Annual Meeting held May 5 – 8, 2023.
Acquisition
of Ilevro, Nevanac, Vigamox, Maxidex and Triesence
In
December 2022, we entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Novartis Technology, LLC and Novartis
Innovative Therapies AG (together, “Novartis”), pursuant to which the Company agreed to purchase from Novartis the exclusive
commercial rights to assets associated with the following ophthalmic products (collectively the “Fab 5 Products”) in the
U.S. (the “Fab 5 Acquisition”):
●
ILEVRO
(nepafenac ophthalmic suspension) 0.3%, a non-steroidal, anti-inflammatory eye drop indicated for pain and inflammation associated
with cataract surgery.
●
NEVANAC
(nepafenac ophthalmic suspension) 0.1%, a non-steroidal, anti-inflammatory eye drop indicated for pain and inflammation associated
with cataract surgery.
●
VIGAMOX
(moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eye drop for the treatment of bacterial conjunctivitis
caused by susceptible strains of organisms.
●
MAXIDEX
(dexamethasone ophthalmic suspension) 0.1%, a steroid eye drop for steroid-responsive inflammatory conditions of the palpebral and
bulbar conjunctiva, cornea, and anterior segment of the globe.
●
TRIESENCE
(triamcinolone acetonide injectable suspension) 40 mg/ml, a steroid injection for the treatment of certain ophthalmic diseases and
for visualization during vitrectomy.
We
closed the Fab 5 Acquisition on January 20, 2023. Under the terms of the Purchase Agreement, we made a one-time payment of $130,000,000
at closing, with up to another $45,000,000 due in a milestone payment related to the timing of the commercial availability of Triesence.
Pursuant to the Purchase Agreement and various ancillary agreements, immediately following the closing and subject to certain conditions,
for a period that lasted approximately six months, and prior to the transfer of the Fab 5 Products new drug applications (the “NDAs”)
to us, Novartis continued to sell the Products on our behalf and transferred the net profit from the sale of the Products to us. Novartis
has agreed to supply certain Products to the Company for a period of time after the NDAs are transferred to us and to assist with technology
transfer of the Products manufacturing to other third-party manufacturers, if needed.
33
On
April 28, 2023, we transferred the NDAs for ILEVRO, NEVANAC and MAXIDEX. In July 2023, we transferred the NDA for VIGAMOX, and the NDA for TRIESENCE is expected to transfer upon around the timing of its commercial availability.
Oaktree
Credit and Guaranty Agreement
On
March 27, 2023, we entered into a Credit and Guaranty Agreement (the “Oaktree Loan”) with Oaktree Fund Administration, LLC,
as administrative agent for the lenders (together, “Oaktree”), providing for a loan to us with a principal amount of up to
$100,000,000. Upon entering into the Oaktree Loan, we drew a principal amount of $65,000,000 from the Oaktree Loan and used the net proceeds
to repay all amounts owed by us pursuant to the BR Loan. No remaining amounts are due under the BR Loan, and no exit or prepayment fees
were paid as a result of the payoff of the B. Riley Loan. The additional principal loan amount of up to $35,000,000 available under the
Oaktree Loan (the “Tranche B”) will be made available to the Company upon the commercialization of TRIESENCE.
On
July 18, 2023, we entered into the First Amendment to Credit Agreement and Guaranty and Consent (the “Oaktree Amendment”)
to the Oaktree Loan. Under the Oaktree Amendment, the overall credit facility size was increased from $100,000,000 to $112,500,000, and
we made other changes related to the Santen Products Acquisition. Upon satisfaction of certain conditions to funding, we drew down a
principal amount of $12,500,000 (the “Loan Increase”) on August 1, 2023 to fund the initial one-time payment associated with
the Santen Products Acquisition and for other working capital and general corporate purposes. No other material changes to the Oaktree
Loan were provided in the Oaktree Amendment. Following entry into the Oaktree Amendment and the funding of the Loan Increase upon closing
of the Santen Products Acquisition, we have drawn down a total principal loan amount of $77,500,000 under the Oaktree Loan and an additional
Tranche B loan amount of up to $35,000,000 remains available to us upon the commercialization of TRIESENCE, provided, that if Tranche
B is not drawn by the Company on or before March 27, 2024, the amount available under Tranche B decreased to $30,000,000.
The
Oaktree Loan is secured by nearly all of the assets, including intellectual property, of the Company and its material subsidiaries. The
Oaktree Loan has a maturity date of January 19, 2026 and carries an interest rate equal to the Secured Overnight Financing Rate (SOFR)
plus 6.5% per annum. The Oaktree Loan requires interest-only payments through its term (there is no amortization of the principal amount
or excess cash flow sweeps during the term of the Oaktree Loan).
HROWM
– Senior Notes Offering
In
December 2022, the Company entered into an underwriting agreement with B. Riley Securities, Inc., as representative of the several underwriters
named therein, pursuant to which we agreed to sell $35,000,000 aggregate principal amount of 11.875% Senior Notes due 2027 (the “2027
Notes”) plus up to an additional $5,250,000 aggregate principal amount of 11.875% Senior Notes due 2027 pursuant to the option
to purchase additional 2027 Notes. In January 2023, the underwriters exercised their option to purchase the additional $5,250,000 aggregate
principal amount of 2027 Notes.
Acquisition
of VEVYE TM U.S. and Canadian Commercial Rights
In
July 2023, we acquired commercial rights of VEVYE (cyclosporine ophthalmic solution) 0.1%, an ophthalmic drug product, for the U.S. and
Canadian markets (the “VEVYE Acquisition”). VEVYE, which is dispensed topically in a unique ten microliter per one drop and
is labeled for twice-daily (BID) dosing, is the first and only cyclosporine-based product indicated for the treatment of both signs and
symptoms of dry eye disease (DED). VEVYE was approved on May 30, 2023 by the FDA. We acquired the commercial rights to VEVYE by entering
into a license agreement with Novaliq GmbH (“Novaliq”). As consideration, we made initial payments to Novaliq totaling $8,000,000
and will pay low double-digit royalties on net sales of VEVYE along with potential commercial milestone payments.
Acquisition
of Certain U.S. and Canadian Commercial Rights to Santen and Eyevance Products
In
July 2023, we entered into an Asset Purchase Agreement with Eyevance Pharmaceuticals, LLC and a License Agreement with Santen S.A.S.
(collectively, the “Santen Agreements”), each a subsidiary of Santen Pharmaceuticals Co., Ltd. (collectively, “Santen”).
Pursuant to the Santen Agreements, we acquired the exclusive commercial rights to assets associated with the following ophthalmic products
(collectively, the “Santen Products”):
34
In
the U.S.:
●
FLAREX®
(fluorometholone acetate ophthalmic suspension) 0.1%, a corticosteroid prepared as a sterile topical ophthalmic suspension indicated
for use in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior
segment of the eye.
●
NATACYN®
(natamycin ophthalmic suspension) 5%, a sterile, antifungal drug for the treatment of fungal blepharitis, conjunctivitis, and keratitis
caused by susceptible organisms, including Fusarium solani keratitis.
●
TOBRADEX®
ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05%, a topical antibiotic and corticosteroid combination for steroid-responsive
inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk
of bacterial ocular infection exists.
●
ZERVIATE®
(cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated
with allergic conjunctivitis.
●
FRESHKOTE®,
a preservative-free formulation for temporary relief of symptoms of dry eye.
In
the U.S. and Canada:
●
VERKAZIA®
(cyclosporine ophthalmic emulsion) 0.1%, an orphan designated drug that is a calcineurin inhibitor immunosuppressant indicated for
the treatment of vernal keratoconjunctivitis.
In
Canada:
●
CATIONORM®
PLUS, a preservative-free formulation for dry eye or allergy relief.
The
transactions pursuant to the Santen Agreements are referred to in this Quarterly Report as the “Santen Products Acquisition.”
Under
the terms of the Santen Agreements, we made an initial one-time payment of $8,000,000. In addition, the Santen Agreements provide for
various one-time milestone payments associated with certain manufacturing-related events as well as low-double digit royalty payments
on net sales of Verkazia and high-single digit royalty payments on net sales of Cationorm Plus. Under the Santen Agreements, we also
assumed certain obligations associated with other third parties that require mid-single digit royalties on sales of Freshkote and Zerviate.
Immediately following the closing and subject to certain conditions, for a period that we expect to last approximately four months, and
prior to the transfer of the Santen Product NDAs and other marketing authorizations to us, Santen will continue to sell the Santen Products
on our behalf and transfer the net profit from the sale of the Santen Products to us.
Common
Stock Offering
In
July 2023, we closed a public offering of shares of our common stock at an offering price of $17.75 per share (the “Offering”).
We sold 3,887,324 shares of our common stock in the Offering, resulting in us receiving aggregate gross proceeds of $69,000,000, before
commissions and other offering expenses.
B.
Riley Loan and Security Agreement – Paid
On
December 14, 2022, we entered into a Loan and Security Agreement (the “BR Loan”) with B. Riley Commercial Capital, LLC, as
Administrative Agent for the Lenders from time to time party thereto. The proceeds of the Loan Agreement were used to finance the Fab
5 Acquisition.
The
BR Loan provided for a loan facility of up to $100,000,000 to the Company with a maturity date of December 14, 2025, at an interest rate
of 10.875% per annum. The BR Loan was secured by an intellectual property security agreement and by all assets of the Company and its
material subsidiaries. The Company drew $59,750,000 of the BR Loan in January 2023, and subsequently paid back the BR Loan in March 2023
at the time of closing the Oaktree Loan. No remaining amounts are due under the BR Loan, and no exit or prepayment fees were paid as
a result of the payoff of the BR Loan.
35
Results
of Operations
The
following period-to-period comparisons of our financial results for the three and six months ended June 30, 2023 and 2022 are not necessarily
indicative of results for any future period.
Revenues
Our
revenues include amounts recorded from sales of proprietary compounded formulations, sales of branded products to wholesalers through
a third-party logistics facility, 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, 2023 and 2022:
For the Three Months Ended
For the Six Months Ended
June 30,
$
June 30,
$
2023
2022
Variance
2023
2022
Variance
Product sales, net
$ 29,542,000
$ 21,518,000
$ 8,024,000
$ 49,995,000
$ 41,858,000
$ 8,137,000
Commission revenues
-
1,212,000
(1,212,000 )
-
2,532,000
(2,532,000 )
Transfer of acquired product profit
3,928,000
593,000
3,335,000
9,578,000
1,053,000
8,525,000
Total revenues
$ 33,470,000
$ 23,323,000
$ 10,147,000
$ 59,573,000
$ 45,443,000
$ 14,130,000
The
increase in revenues between periods was related to an increase in sales of our branded ophthalmology products, as well as an increase
in the transfer of profits related to the Fab 5 Acquisition. This increase in 2023 was offset slightly by a decrease in commissions attributable
to sales of Dexycu® (which agreement terminated January 1, 2023) and a decrease in sales from our non-ophthalmology compounded products
as a result of our sale of those assets in the fourth quarter of 2022.
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, 2023 and 2022:
For the Three Months Ended
For the Six Months Ended
June 30,
$
June 30,
$
2023
2022
Variance
2023
2022
Variance
Cost of sales
$ 10,000,000
$ 6,534,000
$ 3,466,000
$ 18,271,000
$ 12,497,000
$ 5,774,000
The
increase in our cost of sales was largely attributable to the amortization of acquired product NDAs which totaled $2,649,000 and $4,694,000
for the three and six months ended June 30, 2023, respectively, compared to $341,000 and $682,000 during the prior year periods, respectively,
coupled with lesser increases in expenses associated with unit volumes sold and increased direct and indirect costs associated with production
of our products.
Gross
Profit and Margin
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2023
2022
Variance
2023
2022
Variance
Gross profit
$ 23,470,000
$ 16,789,000
$ 6,681,000
$ 41,302,000
$ 32,946,000
$ 8,356,000
Gross margin
70.1 %
72.0 %
-1.9 %
69.3 %
72.5 %
-3.2 %
The
decrease in gross margin between the three and six months ended June 30, 2023 and 2022 is primarily attributable to amortization of acquired
NDAs from the Fab 5 Acquisition, beginning in January 2023.
36
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, 2023 and 2022:
For the Three Months Ended
For the Six Months Ended
June 30,
$
June 30,
$
2023
2022
Variance
2023
2022
Variance
Selling, general and administrative
$ 19,957,000
$ 14,185,000
$ 5,772,000
$ 35,845,000
$ 27,583,000
$ 8,262,000
The
increase in selling, general and administrative expenses between periods was primarily attributable to an increase in stock-based compensation
expense of $3,010,000 and $2,650,000 for the three and six months ended June 30, 2023, respectively, compared to the prior year periods,
including new expenses associated with performance stock units granted in April of 2023. Other areas of increased expenses included regulatory
enhancements, costs to support the transition of recent product acquisitions, and an increase in expenses related to the addition of
new employees in sales, marketing and other departments to support current and expected growth, including the commercial launch of IHEEZO
in April 2023.
Research
and Development Expenses
Our
research and development (“R&D”) 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,
acquired in-process R&D 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, 2023 and 2022:
For the Three Months Ended
For the Six Months Ended
June 30,
$
June 30,
$
2023
2022
Variance
2023
2022
Variance
Research and development
$ 1,161,000
$ 914,000
$ 247,000
$ 1,895,000
$ 1,572,000
$ 323,000
The
increase in R&D expenses between periods was primarily attributable to increased activity related to product acquisitions, launches
and clinical and medical support.
Interest
Expense, Net
Interest
expense, net was $5,704,000 and $10,451,000 for the three and six months ended June 30, 2023, respectively, compared to $1,794,000 and
$3,586,000 for the same periods in 2022, respectively. The increase during the periods ended June 30, 2023 compared to the same periods
in 2022 was primarily due to an increase in the outstanding principal amount of our debt obligations.
37
Equity
in Losses of Unconsolidated Entities
During
the three and six months ended June 30, 2023, we recorded a loss of $0, related to our share of losses in Melt, compared to $2,646,000
and $5,532,000 for the same periods in 2022, respectively.
Investment
Gain (Loss) from Eton
During
the three and six months ended June 30, 2023, we recorded a (loss)/gain of $(714,000) and $1,328,000, respectively, related to the change
in fair market value of Eton’s common stock compared to losses of $3,449,000 and $3,310,000 for the same periods in 2022, respectively.
Loss
on Extinguishment of Debt
During
the six months ended June 30, 2023, we recorded a loss on extinguishment of debt of $5,465,000, related to the payoff of the B. Riley
Loan.
Other
Expense, Net
During
the three and six months ended June 30, 2023, we recorded other expense, net of $178,000 and $149,000, respectively, related primarily
to transition services and write-off of inventories associated with the divestment of our non-ophthalmology business.
Liquidity
and Capital Resources
Liquidity
Our
cash on hand at June 30, 2023 was $22,754,000, compared to $96,270,000 at December 31, 2022.
As
of the date of this Quarterly Report, we believe that cash and cash equivalents of $22,754,000 at June 30, 2023, along with proceeds
received subsequent to June 30, 2023 from the Offering and Oaktree Amendment, 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 investments in Eton, Surface, Melt, and/or any of our consolidated subsidiaries. However, we may
pursue acquisitions of 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 drug products,
drug candidates, and/or assets or technologies, pharmacies, outsourcing facilities, drug company and manufacturers, 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, 2023
June 30, 2022
Net cash (used in) provided by operating activities
$ (3,648,000 )
$ 5,827,000
Net cash used in investing activities
(132,219,000 )
(669,000 )
Net cash provided by (used in) financing activities
62,351,000
(887,000 )
Net change in cash and cash equivalents
(73,516,000 )
4,271,000
Cash and cash equivalents at beginning of the period
96,270,000
42,167,000
Cash and cash equivalents at end of the period
$ 22,754,000
$ 46,438,000
38
Operating
Activities
Net
cash used in operating activities during the six months ended June 30, 2023 was $(3,648,000) compared to cash provided by operating activities
of $5,827,000 during the same period in the prior year. The increase in net cash used in operating activities between the periods was
mainly attributed to an increase in accounts receivable related to payment terms for the profit transfer associated with the Fab 5 Acquisition
and branded product sales, which was an increase in our receivables of $12,038,000 during the six months ended June 30, 2023 compared
to an increase of $2,314,000 during the six months ended June 30, 2022. The increase in net cash used in operating activities was also
attributed to an increase in inventory levels, coupled with operating expenses associated with the commercial launch of IHEEZO and increased
costs of goods sold.
Investing
Activities
Net
cash used in investing activities during the six months ended June 30, 2023 was $(132,219,000) compared to $(669,000) during the same
period in the prior year. Cash used in investing activities in 2023 was primarily associated with the Fab 5 Acquisition. Cash used in
investing activities in 2022 was primarily associated with equipment and software purchases.
Financing
Activities
Net
cash provided by (used in) financing activities during the six months ended June 30, 2023 and 2022 was $62,351,000 and $(887,000), respectively.
Cash provided by financing activities during the six months ended June 30, 2023 was primarily related to proceeds received from the sale
of the 2027 Notes, and proceeds from the Oaktree Loan. Cash used in financing activities during the six months ended June 30, 2022 was
primarily related to payment of payroll taxes upon vesting of RSUs in exchange for shares withheld from the employee.
Sources
of Capital
Our
principal sources of cash consist of cash provided by operating activities from our ImprimisRx and branded pharmaceutical businesses,
and in 2022 and 2023, proceeds from the sale of senior notes, the Offering and the Oaktree Loan and Oaktree Amendment. We may also sell
some or all of our ownership interests in Surface, Melt or our other subsidiaries, along with some or all of the remaining portion of
our Eton common stock.
We
may acquire new products, product candidates and/or businesses and, 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.
39
Recently
Issued and Adopted Accounting Pronouncements
See
Note 2 to our unaudited 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, 2023. 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, 2023, the end of
the period covered by this Quarterly Report.
Changes
in Internal Control 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, 2023, that has materially affected, or is reasonably likely to materially affect, our internal control over financial
reporting.
40
PART
II
OTHER
INFORMATION
Item
1. Legal Proceedings
See
Note 16 to our unaudited 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
In
addition to the other information contained in this Quarterly Report you should consider the risk factors and the other information in
our Annual Report on Form 10-K for the year ended December 31, 2022, including our audited financial statements and the related notes
and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” If any such risks actually
occur, 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.
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
On
August 4, 2023, the Company amended its License and Supply Agreement originally entered into on July 25, 2021 with Sintetica, S.A. to
allow for early payment of commercial related milestones associated with sales of IHEEZO in exchange for an 11% reduction in the milestone
amounts.
Item
6. Exhibits
Exhibit
Number
Description
10.1*
First Amendment to Credit Agreement and Guaranty and Consent, date July 18, 2023, to the Credit Agreement and Guaranty, dated March 27, 2023, between the Company and Oaktree Fund Administration, LLC.
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, 2023, has been formatted in Inline
XBRL.
*
Filed
herewith.
**
Furnished
herewith.
41
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 9, 2023
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)
42
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.