Item 1. Financial Statements
Item
1. Financial Statements (unaudited)
HARROW,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
September 30,
December 31,
2024
2023
(Unaudited)
ASSETS
Current assets
Cash and cash equivalents
$ 72,601,000
$ 74,085,000
Investment in Eton Pharmaceuticals
-
8,681,000
Accounts receivable, net
53,734,000
36,261,000
Inventories
10,156,000
10,867,000
Prepaid expenses and other current assets
10,571,000
9,588,000
Total current assets
147,062,000
139,482,000
Property, plant and equipment, net
3,625,000
3,521,000
Capitalized software costs, net
1,869,000
2,138,000
Operating lease right-of-use assets, net
9,379,000
6,785,000
Intangible assets, net
189,272,000
159,906,000
Goodwill
332,000
332,000
TOTAL ASSETS
$ 351,539,000
$ 312,164,000
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable and accrued expenses
$ 25,277,000
$ 24,581,000
Contingent consideration payable
37,000,000
-
Accrued rebates and copay assistance
24,899,000
18,432,000
Accrued payroll and related liabilities
7,185,000
5,450,000
Deferred revenue and customer deposits
137,000
75,000
Current portion of operating lease obligations
507,000
806,000
Total current liabilities
95,005,000
49,344,000
Operating lease obligations, net of current portion
9,500,000
6,524,000
Accrued expenses, net of current portion
2,713,000
2,713,000
Deferred tax liability
643,000
-
Notes payable, net of unamortized debt discounts
186,057,000
183,172,000
TOTAL LIABILITIES
293,918,000
241,753,000
Commitments and contingencies
-
STOCKHOLDERS’ EQUITY
Common stock, $ 0.001 par value, 50,000,000 shares authorized, 35,611,365 and 35,168,260 shares issued and outstanding at
September 30, 2024 and December 31, 2023, respectively
35,000
35,000
Additional paid-in capital
216,103,000
204,635,000
Accumulated deficit
( 158,162,000 )
( 133,904,000 )
TOTAL HARROW, INC. STOCKHOLDERS’ EQUITY
57,976,000
70,766,000
Noncontrolling interests
( 355,000 )
( 355,000 )
TOTAL STOCKHOLDERS’ EQUITY
57,621,000
70,411,000
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 351,539,000
$ 312,164,000
The
accompanying notes are an integral part of these condensed consolidated financial statements
3
HARROW,
INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the Three Months Ended
For the Nine Months Ended
September 30,
September 30,
2024
2023
2024
2023
Revenues:
Product sales, net
$ 49,019,000
$ 31,809,000
$ 132,398,000
$ 81,804,000
Other revenues
238,000
2,456,000
385,000
12,034,000
Total revenues
49,257,000
34,265,000
132,783,000
93,838,000
Cost of sales
( 12,018,000 )
( 10,067,000 )
( 35,110,000 )
( 28,338,000 )
Gross profit
37,239,000
24,198,000
97,673,000
65,500,000
Operating expenses:
Selling, general and administrative
33,645,000
21,033,000
94,275,000
56,878,000
Research and development
2,273,000
1,421,000
7,475,000
3,316,000
Total operating expenses
35,918,000
22,454,000
101,750,000
60,194,000
Income (loss) from operations
1,321,000
1,744,000
( 4,077,000 )
5,306,000
Other (expense) income:
Interest expense, net
( 5,525,000 )
( 5,749,000 )
( 16,411,000 )
( 16,200,000 )
Investment (loss) gain from Eton Pharmaceuticals
-
1,348,000
( 3,171,000 )
2,676,000
Loss on extinguishment of debt
-
-
-
( 5,465,000 )
Other income (expenses), net
4,000
( 195,000 )
76,000
( 344,000 )
Total other expense, net
( 5,521,000 )
( 4,596,000 )
( 19,506,000 )
( 19,333,000 )
Loss before income taxes
( 4,200,000 )
( 2,852,000 )
( 23,583,000 )
( 14,027,000 )
Provision for income taxes
( 20,000 )
( 1,539,000 )
( 675,000 )
( 1,236,000 )
Net loss
$ ( 4,220,000 )
$ ( 4,391,000 )
$ ( 24,258,000 )
$ ( 15,263,000 )
Basic and diluted net loss per share of common stock
$ ( 0.12 )
$ ( 0.13 )
$ ( 0.68 )
$ ( 0.48 )
Weighted average number of shares of common stock
outstanding, basic and diluted
35,702,200
34,255,197
35,597,409
31,689,947
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
4
HARROW,
INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
For
the periods ended September 30, 2024 and 2023
Total
Total
Common Stock
Additional
Harrow, Inc.
Noncontrolling
Total
Par
Paid-in
Accumulated
Stockholders’
Interest
Stockholders’
Shares
Value
Capital
Deficit
Equity
Equity
Equity
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:
Public offering, net of offering costs
3,887,324
4,000
64,516,000
-
64,520,000
-
64,520,000
Exercise of consultant stock-based options
10,000
-
85,000
-
85,000
-
85,000
Exercise of employee stock-based options
219,246
-
270,000
-
270,000
-
270,000
Vesting of RSUs and PSUs
1,810,673
2,000
( 2,000 )
-
-
-
-
Shares withheld related to net share settlement of equity awards
( 711,152 )
( 1,000 )
( 12,970,000 )
-
( 12,971,000 )
-
( 12,971,000 )
Stock-based compensation expense
-
-
11,521,000
-
11,521,000
-
11,521,000
Net loss
-
-
-
( 15,263,000 )
( 15,263,000 )
-
( 15,263,000 )
Balance at September 30, 2023
35,117,621
$ 35,000
$ 200,478,000
$ ( 124,756,000 )
$ 75,757,000
$ ( 355,000 )
$ 75,402,000
Balance at December 31, 2023
35,168,260
$ 35,000
$ 204,635,000
$ ( 133,904,000 )
$ 70,766,000
$ ( 355,000 )
$ 70,411,000
Issuance of common stock in connection with:
Exercise of employee stock-based options
248,175
-
1,005,000
-
1,005,000
-
1,005,000
Vesting of RSUs
332,517
-
-
-
-
-
-
Shares withheld related to net share settlement of equity awards
( 137,587 )
-
( 2,362,000 )
-
( 2,362,000 )
-
( 2,362,000 )
Stock-based compensation expense
-
-
12,825,000
-
12,825,000
-
12,825,000
Net loss
-
-
-
( 24,258,000 )
( 24,258,000 )
-
( 24,258,000 )
Balance at September 30, 2024
35,611,365
$ 35,000
$ 216,103,000
$ ( 158,162,000 )
$ 57,976,000
$ ( 355,000 )
$ 57,621,000
Total
Total
Common Stock
Additional
Harrow, Inc.
Noncontrolling
Total
Par
Paid-in
Accumulated
Stockholders’
Interest
Stockholders’
Shares
Value
Capital
Deficit
Equity
Equity
Equity
Balance at June 30, 2023
30,276,938
$ 30,000
$ 142,742,000
$ ( 120,365,000 )
$ 22,407,000
$ ( 355,000 )
$ 22,052,000
Issuance of common stock in connection with:
Public offering, net of offering costs
3,887,324
4,000
64,516,000
-
64,520,000
-
64,520,000
Exercise of employee stock-based options
2,430
-
18,000
-
18,000
-
18,000
Vesting of PSUs
1,567,913
2,000
( 2,000 )
-
-
-
-
Shares withheld related to net share settlement of equity awards
( 616,984 )
( 1,000 )
( 11,272,000 )
-
( 11,273,000 )
-
( 11,273,000 )
Stock-based compensation expense
-
-
4,476,000
-
4,476,000
-
4,476,000
Net loss
-
-
-
( 4,391,000 )
( 4,391,000 )
-
( 4,391,000 )
Balance at September 30, 2023
35,117,621
$ 35,000
$ 200,478,000
$ ( 124,756,000 )
$ 75,757,000
$ ( 355,000 )
$ 75,402,000
Balance at June 30, 2024
35,479,492
$ 35,000
$ 212,439,000
$ ( 153,942,000 )
$ 58,532,000
$ ( 355,000 )
$ 58,177,000
Balance
35,479,492
$ 35,000
$ 212,439,000
$ ( 153,942,000 )
$ 58,532,000
$ ( 355,000 )
$ 58,177,000
Issuance of common stock in connection with:
Exercise of employee stock-based options
160,980
-
484,000
-
484,000
-
484,000
Shares withheld related to net share settlement of equity awards
( 29,107 )
-
( 1,205,000 )
-
( 1,205,000 )
-
( 1,205,000 )
Stock-based compensation expense
-
-
4,385,000
-
4,385,000
-
4,385,000
Net loss
-
-
-
( 4,220,000 )
( 4,220,000 )
-
( 4,220,000 )
Balance at September 30, 2024
35,611,365
$ 35,000
$ 216,103,000
$ ( 158,162,000 )
$ 57,976,000
$ ( 355,000 )
$ 57,621,000
Balance
35,611,365
$ 35,000
$ 216,103,000
$ ( 158,162,000 )
$ 57,976,000
$ ( 355,000 )
$ 57,621,000
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
5
HARROW,
INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Nine Months Ended
September 30,
2024
2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$ ( 24,258,000 )
$ ( 15,263,000 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization of property, plant and equipment and software development costs
1,382,000
1,095,000
Amortization of intangible assets
7,708,000
7,634,000
Amortization of operating lease right-of-use assets
636,000
541,000
(Recovery of) provision for credit losses
( 20,000 )
68,000
Amortization of debt issuance costs and debt discount
2,985,000
2,568,000
Investment loss (gain) from investment in Eton
3,171,000
( 2,676,000 )
Loss on extinguishment of debt
-
5,465,000
Loss on disposal of intangible assets
-
22,000
Stock-based compensation
12,825,000
11,521,000
Deferred income tax
643,000
-
Changes in assets and liabilities:
Accounts receivable
( 17,453,000 )
( 12,287,000 )
Inventories
711,000
( 2,383,000 )
Prepaid expenses and other current assets
( 983,000 )
( 4,079,000 )
Accounts payable, accrued expenses, accrued rebates and copay assistance
6,433,000
1,584,000
Accrued payroll and related liabilities
1,735,000
1,294,000
Deferred revenue and customer deposits
62,000
40,000
NET CASH USED IN OPERATING ACTIVITIES
( 4,423,000 )
( 4,856,000 )
CASH FLOWS FROM INVESTING ACTIVITIES
Net proceeds from sale of investment in Eton Pharmaceuticals
5,510,000
-
Investment in patent and trademark assets
( 74,000 )
-
Purchase of product NDAs and related patents
-
( 151,084,000 )
Purchases of property, plant and equipment
( 1,040,000 )
( 1,266,000 )
NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES
4,396,000
( 152,350,000 )
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from 11.875 % notes payable, net of costs
-
4,961,000
Proceeds from Oaktree Loan, net of costs
-
73,552,000
Payment of debt issuance costs
( 100,000 )
-
Payment of payroll taxes upon vesting of PSUs, RSUs and exercise of stock options
( 2,362,000 )
( 12,971,000 )
Proceeds from exercise of stock options
1,005,000
355,000
Proceeds from B. Riley senior secured note, net of costs
-
55,879,000
Repayment of B. Riley senior secured note
-
( 59,750,000 )
Proceeds from public offering of common stock, net of costs
-
64,520,000
NET CASH (USED IN) PROVIDED BY FINANCING ACTIVITIES
( 1,457,000 )
126,546,000
NET CHANGE IN CASH AND CASH EQUIVALENTS
( 1,484,000 )
( 30,660,000 )
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
74,085,000
96,270,000
CASH AND CASH EQUIVALENTS AT END OF PERIOD
$ 72,601,000
$ 65,610,000
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for income taxes
$ -
$ -
Cash paid for interest
$ 15,553,000
$ 12,279,000
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Reclassification of deferred financing costs
$ -
$ 1,950,000
Accrual of exit fee related to Oaktree Loan
$ -
$ 2,713,000
Insurance premium financed
$ -
$ 1,321,000
Purchase of product NDAs associated with contingent consideration payable
$ 37,000,000
$ -
Purchase of property, plant and equipment included in
accounts payable and accrued expenses
$ 177,000
$ 11,000
Right-of-use assets obtained in exchange for new operating lease obligations
$ 3,230,000
$ -
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
6
HARROW,
INC.
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
the Three and Nine Months Ended September 30, 2024 and 2023
NOTE
1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
Company
and Background
Harrow, Inc. (together with its consolidated subsidiaries, 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 owns commercial rights to one of the largest portfolios of branded ophthalmic pharmaceutical products
in the U.S, all of which are marketed under its Harrow name. The Company also owns and operates ImprimisRx, one of the nation’s
leading ophthalmology-focused pharmaceutical-compounding businesses.
Basis
of Presentation
The
Company has prepared the accompanying unaudited condensed consolidated financial statements in accordance with accounting principles
generally accepted in the United States of America (“GAAP”) for interim financial information and in accordance with the
rules and regulations of the U.S. Securities and Exchange Commission. Accordingly, they do not include all of the information and footnotes
required by GAAP for audited financial statements. In the opinion of management, all adjustments (consisting of only normal recurring
adjustments) considered necessary for a fair presentation have been included. Operating results for the three and nine months ended September
30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024 or for any other period.
For further information, refer to the Company’s audited consolidated financial statements and notes thereto included in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2023.
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 nine months ended September 30, 2024 to the significant accounting policies described
in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Segments
The
Company’s chief operating decision-maker is its Chief Executive Officer who makes resource allocation decisions and assesses performance
based on financial information presented as operating segments. During the period ended September 30, 2024, the Company identified two
operating segments as reportable segments. See Note 15 for more information regarding the Company’s reportable segments.
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.
7
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.
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 September 30, 2024 was $ 53,734,000 , net
of $ 281,000 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 September 30, 2024:
SCHEDULE
OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS
Balance at January 1, 2024
$ 371,000
Change in expected credit losses
( 20,000 )
Write-offs, net of recoveries
( 70,000 )
Balance at September 30, 2024
$ 281,000
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 for substantially the full term of the assets or liabilities.
●
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
December 31, 2023, the Company measured its investment in Eton Pharmaceuticals, Inc. (“Eton”) on a recurring basis. The Company’s
investment in Eton was classified as a Level 1 as the fair value was determined using quoted market prices in active markets for the
same securities. As of December 31, 2023, the fair market value of the Company’s investment in Eton was $ 8,681,000 . In April 2024,
the Company sold all of its shares of common stock it held of Eton in a block trade at a gross price of $ 3.00 per share. After deducting
trading expenses and commissions of approximately $ 436,000 , the Company received net proceeds of $ 5,510,000 and recorded a loss of $ 3,171,000
related to the sale of its investment in Eton.
8
The
Company’s 2026 Notes (as defined in Note 11) are carried at face value, including the unamortized premium, less unamortized debt
issuance costs, the 2027 Notes (as described in Note 11) are carried at face value less unamortized debt issuance costs, and the Oaktree
Loan (as defined in Note 11) 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
September 30, 2024
December 31, 2023
Carrying Value
Fair Value
Carrying Value
Fair Value
2026 Notes
$ 73,804,000
$ 76,830,000
$ 73,218,000
$ 70,260,000
2027 Notes
$ 37,950,000
$ 43,084,000
$ 37,413,000
$ 40,363,000
Oaktree Loan
$ 74,303,000
$ 78,663,000
$ 72,541,000
$ 76,627,000
The
Company’s other financial instruments include cash and cash equivalents, accounts receivable, accounts payable and accrued expenses,
accrued payroll and related liabilities, contingent consideration payable, 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.
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”), and market-based vesting performance stock units (“PSUs”), outstanding during the period.
Common equivalent shares (using the treasury stock method) from stock options, unvested RSUs, and unvested PSUs were 4,411,488 and 4,588,982
at September 30, 2024 and 2023, 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 ceases providing services. The
number of shares underlying vested RSUs at September 30, 2024 and 2023 was 195,696 and 244,352 , respectively.
The
following table shows the computation of basic and diluted net loss per share of common stock:
SCHEDULE
OF BASIC NET LOSS PER SHARE OF COMMON STOCK
For the Three Months Ended September 30,
For the Nine Months Ended September 30,
2024
2023
2024
2023
Numerator – net loss
$ ( 4,220,000 )
$ ( 4,391,000 )
$ ( 24,258,000 )
$ ( 15,263,000 )
Denominator – weighted average number of shares outstanding, basic and diluted
35,702,200
34,255,197
35,597,409
31,689,947
Net loss per share, basic and diluted
$ ( 0.12 )
$ ( 0.13 )
$ ( 0.68 )
$ ( 0.48 )
Income
Taxes
The
Company’s effective tax rate was ( 2.95 ) % and ( 8.81 ) % for the nine months ended September 30, 2024 and 2023, respectively. The Company’s
effective tax rate for the nine months ended September 30, 2024 and 2023 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, Section 162(m) excess officer compensation
limitation, share-based compensation and the change in valuation allowance. In the current period ended September 30, 2024, the Company met the exception to using the estimated annual effective
tax rate. The current period income tax expense reflects year-to-date income tax expense. The prior year third quarter income tax expense
was recorded using the estimated annual effective tax rate.
9
As
of September 30, 2024 and December 31, 2023, there were no unrecognized tax benefits included in the condensed consolidated balance sheets
that would, if recognized, affect the effective tax rate.
Investment
in Melt Pharmaceuticals, Inc. – Related Party
The
Company owns 3,500,000 shares of common stock and 2,334,256 shares of preferred stock of Melt (representing in aggregate approximately
46 % of Melt’s equity interests as of September 30, 2024). 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. Therefore,
the Company uses the equity method of accounting for the Melt investment. Under this method, the Company recognizes earnings and losses
in Melt in its consolidated financial statements and adjusts the carrying amount of its investment in Melt accordingly. Any intra-entity
profits and losses are eliminated.
On
a quarterly basis, management assesses whether there are any indicators that the carrying value of the Company’s equity method
investments may be other than temporarily impaired. Indicators include financial condition, operating performance, and near-term prospects
of the investee. To the extent indicators suggest that a loss in value may have occurred, the Company will evaluate both quantitative
and qualitative factors to determine if the loss in value is other than temporary. If a potential loss in value is determined to be other
than temporary, the Company will recognize an impairment loss based on the estimated fair value of the equity method investments. The
Company has no investments other than its common stock and preferred stock positions in Melt and no other requirements to advance funds
to Melt.
The
following table summarizes the Company’s investments in Melt as of September 30, 2024:
SCHEDULE OF INVESTMENT
Cost
Share of Equity Method
Net
Carrying
Basis
Losses
Value
Common stock
$ 5,810,000
$ ( 5,810,000 )
$ -
Preferred stock
18,397,000
( 18,397,000 )
-
$ 24,207,000
$ ( 24,207,000 )
$ -
See
Note 4 for more information and related party disclosure regarding Melt.
Accounting
Guidance Issued but Not Adopted at September 30, 2024
In
October 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-06, Disclosure Improvements—Codification Amendments
in Response to the SEC’s Disclosure Update and Simplification Initiative . This ASU modifies the disclosure or presentation
requirements of a variety of topics in the codification by aligning them with the SEC’s regulations. The amendments to the various
topics should be applied prospectively, and the effective date for the Company for each amendment will be determined based on the effective
date of the SEC’s removal of the related disclosure from Regulation S-X or Regulation S-K. If the SEC has not removed the applicable
requirement by June 30, 2027, then the related amendment in ASU 2023-06 will be removed from the codification and will not become effective.
Early adoption of this ASU is prohibited. The Company does not expect the amendments in this ASU to have a material impact on the disclosures
or presentation on its consolidated financial statements.
In
November 2023, FASB issued ASU 2023-07, Segment Reporting (Topic 280) - Improvements to Reportable Segment Disclosures , which
enhances the disclosures required for operating segments in the Company’s annual and interim consolidated financial statements.
ASU 2023-07 is effective for the Company in our annual reporting for fiscal 2024 and for interim period reporting beginning in fiscal
2025 on a retrospective basis, with all required disclosures to be made for all prior periods presented in the consolidated financial
statements. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2023-07 on its consolidated financial
statements.
In
December 2023, FASB issued ASU 2023-09, Income Taxes (Topic 740) - Improvements to Income Tax Disclosures , which enhances
the disclosures required for income taxes in the Company’s annual consolidated financial statements. Notably, this ASU requires
entities to disclose specific categories in the effective tax rate reconciliation and provide additional information for reconciling
items that meet a quantitative threshold. ASU 2023-09 is effective for the Company in its annual reporting for fiscal year 2025 on a
prospective basis. Early adoption and retrospective reporting are permitted. The Company is currently evaluating the impact of ASU 2023-09
on its consolidated financial statements.
10
In
November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation
Disclosures, to improve the disclosures by a public business entity about the types of expenses in commonly presented expense captions.
This ASU is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December
15, 2027, with early adoption permitted. The Company is currently evaluating the impact of ASU 2024-03 on its consolidated financial
statements.
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) product revenues, including 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 transfer of acquired product sales and profits, and (3) revenue recognized from intellectual property licenses and related
arrangements.
Product
Revenues
The
Company sells prescription medications directly through its pharmacy, outsourcing facility and 3PL partner. Revenue from the Company’s
pharmacy services include: (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, copay assistance 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.
Revenues
From Transfer of Acquired Product Sales and Profits
The
Company has entered into agreements whereby it purchased the exclusive commercial rights to assets associated with certain ophthalmic
products from other pharmaceutical companies (the “Sellers”). During a temporary, transition period, the Sellers continue
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 Sellers
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 Sellers invoice 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 sales and profit transferred. The estimated
Chargebacks are recorded as a reduction in revenues from transfer of acquired product sales and profits in the Company’s consolidated
statements of operations, and recorded as a reduction to accounts receivable in the consolidated balance sheets, at the time the revenue
is recognized.
11
Intellectual
Property License and Related Arrangements Revenues
As
of September 30, 2024, the Company held five intellectual property licenses and related arrangements pursuant to which the Company has
agreed to license or sell to a customer 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 deliverables are 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 consisted of the following:
SCHEDULE OF DISAGGREGATED REVENUE
For the Three Months Ended
For the Nine Months Ended
September 30,
September 30,
2024
2023
2024
2023
Product sales, net
$ 49,019,000
$ 31,809,000
$ 132,398,000
$ 81,804,000
Other revenues
238,000
2,456,000
385,000
12,034,000
Total revenues
$ 49,257,000
$ 34,265,000
$ 132,783,000
$ 93,838,000
Deferred
revenue and customer deposits at September 30, 2024 and December 31, 2023 were $ 137,000 and $ 75,000 , respectively. All deferred revenue
and customer deposit amounts at December 31, 2023 were recognized as revenue during the nine months ended September 30, 2024.
NOTE
4. INVESTMENT IN, AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC. - RELATED PARTY TRANSACTIONS
In
December 2018, the Company entered into an Asset Purchase Agreement with Melt (the “Melt APA”). Pursuant to the terms of
the Melt APA, 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 APA, 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 entered into a Management Services Agreement (the “Melt MSA”), whereby the Company provided
to Melt certain administrative services and support, including bookkeeping, web services and human resources related activities, and
Melt was required to pay the Company a monthly amount of $ 10,000 .
The Melt MSA was terminated effective July 1, 2023. During the three and nine months ended September 30, 2024, the Company did not
record any reimbursable expenses and amounts payable by Melt pursuant to the Melt MSA. During the three and nine months ended
September 30, 2023, the Company recorded $ 0
and $ 89,000
due from Melt for reimbursable expenses and amounts payable by Melt pursuant to the Melt MSA, which amounts are included in prepaid
expenses and other current assets in the accompanying condensed consolidated balance sheets. As
of both September 30, 2024 and December 31, 2023, the Company was due $ 228,000
from Melt for reimbursable expenses and amounts payable under the Melt MSA.
12
In
March 2024, Melt completed its Series B Preferred Stock financing which raised gross proceeds of approximately $ 23,900,000 .
The
Company’s Chief Executive Officer, Mark L. Baum, is a member of the Melt board of directors. The Melt board of directors consists
of five members, including Mr. Baum. Mr. Baum 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
For the Nine Months Ended
September 30,
2024
2023
Revenues, net
$ -
$ -
Loss from operations
$ ( 11,334,000 )
$ ( 3,663,000 )
Net loss
$ ( 10,942,000 )
$ ( 5,407,000 )
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE
OF CONDENSED BALANCE SHEET
At September 30,
At December 31,
2024
2023
Current assets
$ 7,366,000
$ 13,404,000
Total assets
$ 7,366,000
$ 13,404,000
Total liabilities
$ 5,242,000
$ 3,922,000
Total stockholders’ equity
2,124,000
9,482,000
Total liabilities and stockholders’ equity
$ 7,366,000
$ 13,404,000
NOTE
5. INVENTORIES
Inventories
are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, branded pharmaceutical
products, including those held at the Company’s 3PL partner, related laboratory supplies and active pharmaceutical ingredients.
The composition of inventories was as follows:
SCHEDULE
OF INVENTORIES
At September
30, 2024
At December 31,
2023
Raw materials
$ 5,306,000
$ 5,477,000
Work in progress
176,000
54,000
Finished goods
4,674,000
5,336,000
Total inventories
$ 10,156,000
$ 10,867,000
NOTE
6. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets consisted of the following:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
At September 30, 2024
At December 31, 2023
Prepaid insurance
$ 1,639,000
$ 1,241,000
Prepaid computer software licenses and related expenses
619,000
1,613,000
Prefunded co-pay assistance
4,514,000
-
Other prepaid expenses
1,749,000
906,000
Receivable due from Melt
228,000
228,000
Prepaid FY 2024 Prescription Drug User (“PDUFA”) fees
-
3,438,000
Deferred Oaktree Loan commitment fee
372,000
409,000
Deposits and other current assets
1,450,000
1,753,000
Total prepaid expenses and other current assets
$ 10,571,000
$ 9,588,000
13
NOTE
7. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment consisted of the following:
SCHEDULE
OF PROPERTY, PLANT AND EQUIPMENT
At September 30, 2024
At December 31, 2023
Property, plant and equipment:
Computer hardware
$ 1,477,000
$ 1,322,000
Furniture and equipment
965,000
936,000
Lab and pharmacy equipment
5,304,000
4,564,000
Leasehold improvements
6,899,000
6,771,000
Property, plant and equipment, gross
14,645,000
13,593,000
Accumulated depreciation
( 11,020,000 )
( 10,072,000 )
Property, plant and equipment,
net
$ 3,625,000
$ 3,521,000
For
the three and nine months ended September 30, 2024, depreciation related to property, plant and equipment was $ 351,000 and $ 948,000 ,
respectively, compared to $ 290,000 and $ 743,000 during the same periods in 2023, respectively.
NOTE
8. CAPITALIZED SOFTWARE COSTS
Capitalized
software costs consisted of the following:
SCHEDULE OF CAPITALIZED SOFTWARE COSTS
At September 30, 2024
At December 31, 2023
Capitalized software costs:
Capitalized internal-use software development costs
$ 3,366,000
$ 2,780,000
Acquired third-party software license for internal-use
205,000
159,000
Total gross capitalized software for internal-use
3,571,000
2,939,000
Accumulated amortization
( 1,702,000 )
( 1,268,000 )
Capitalized internal-use software in process
-
467,000
Total capitalized software
costs net
$ 1,869,000
$ 2,138,000
The
Company recorded amortization expense of $ 146,000 and $ 434,000 related to capitalized software costs during the three and nine months
ended September 30, 2024, respectively, and $ 115,000 and $ 352,000 during the same periods in 2023, respectively.
NOTE
9. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at September 30, 2024 consisted of the following:
SCHEDULE OF INTANGIBLE ASSETS
Amortization
Periods
(in years)
Cost
Accumulated
Amortization
Net
Carrying Value
Patents
7 - 19
$ 610,000
$ ( 207,000 )
$ 403,000
Licenses
7 - 20
50,000
( 36,000 )
14,000
Trademarks
Indefinite
226,000
-
226,000
Acquired NDAs
4 - 15
207,398,000
( 18,899,000 )
188,499,000
Customer relationships
3 - 15
596,000
( 539,000 )
57,000
Trade name
5
75,000
( 7,000 )
68,000
Non-competition clause
3 - 4
50,000
( 50,000 )
-
State pharmacy licenses
25
8,000
( 3,000 )
5,000
$ 209,013,000
$ ( 19,741,000 )
$ 189,272,000
14
Amortization
expense for intangible assets was as follows:
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
For the Three Months Ended
For the Nine Months Ended
September 30,
September 30,
2024
2023
2024
2023
Patents
$ 19,000
$ 22,000
$ 47,000
$ 65,000
Licenses
34,000
2,000
34,000
7,000
Acquired NDAs
2,547,000
2,551,000
7,606,000
7,526,000
Customer relationships
3,000
9,000
19,000
36,000
Trade name
1,000
-
1,000
-
State pharmacy licenses
1,000
-
1,000
-
Amortization
expense of intangible assets
$ 2,605,000
$ 2,584,000
$ 7,708,000
$ 7,634,000
Estimated
future amortization expenses for the Company’s intangible assets at September 30, 2024 was as follows:
SCHEDULE
OF ESTIMATED FUTURE AMORTIZATION EXPENSE
Remainder of 2024
$ 4,025,000
2025
16,630,000
2026
16,630,000
2027
16,281,000
2028
15,933,000
Thereafter
119,547,000
Intangible
assets
$ 189,046,000
In
connection with an asset purchase agreement between Novartis and the Company, the Company is required to make a milestone payment
following the release of the first commercially available batch of TRIESENCE . During the three months ended September 30, 2024, the
Company determined that it was probable the first commercial batch would be released and, as such, recognized the $ 37,000,000
milestone payment as an increase in the amount of intangible assets for Acquired NDAs.
There
were no changes to the carrying value of the Company’s goodwill during the three and nine months ended September 30, 2024 and 2023.
NOTE
10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses consisted of the following:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
At
September 30,
At
December 31,
2024
2023
Accounts payable
$ 23,202,000
$ 21,424,000
Accrued insurance premium
21,000
873,000
Other accrued payments
106,000
306,000
Accrued interest (see Note 11)
1,948,000
1,978,000
Accrued exit fee for Oaktree Loan (see Note 11)
2,713,000
2,713,000
Total accounts payable and accrued expenses
$ 27,990,000
$ 27,294,000
Less: current portion
( 25,277,000 )
( 24,581,000 )
Non-current total accrued expenses
$ 2,713,000
$ 2,713,000
15
NOTE
11. DEBT
Oaktree
Loan Due 2026
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 (“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 . In July 2023, the Company drew an additional principal amount of $ 12,500,000 and entered into the First Amendment to the
Oaktree Loan (the “First Amendment”). Under the First Amendment, the overall credit facility size was increased from
$ 100,000,000 to $ 112,500,000 . The additional principal loan amount of up to $ 35,000,000 available under the Oaktree Loan (“Tranche
B”) was to be made available to the Company upon the commercialization of TRIESENCE. Since Tranche B was not drawn by the Company on or
before March 27, 2024, the amount available under Tranche B decreased to $ 30,000,000 . While undrawn, the Company is required to pay a
commitment fee related to the Tranche B amount equal to 2 % per annum, payable quarterly. This fee is recorded within prepaid expenses
and other current assets and is being amortized on a straight-line basis over the access period.
Interest
expense related to the Oaktree Loan totaled $ 3,026,000 and $ 8,923,000 for the three and nine months ended September 30, 2024, respectively,
and included the amortization of debt issuance costs and discount of $ 656,000 and $ 1,861,000 , respectively. Interest expense related
to the Oaktree Loan totaled $ 2,995,000 and $ 5,660,000 for the three and nine months ended
September 30, 2023, respectively, and included the amortization of debt issuance costs and discount of $ 567,000
and $ 1,093,000 , respectively.
The
Oaktree Loan carries an exit fee equal to 3.5 % of the aggregate principal amount owed, payable at maturity. As of September 30, 2024
and December 31, 2023, the Company had recorded in accrued expenses the total exit fee liability of $ 2,713,000 and $ 2,713,000 , respectively.
HROWM
– 11.875% Senior Notes Due 2027
In
December 2022 and January 2023, the Company closed offerings of $ 40,250,000 aggregate principal amount of 11.875 % senior notes due December
2027 (the “2027 Notes”). Interest expense related to the 2027 Notes totaled $ 1,376,000
and $ 4,121,000 for the three and nine months ended September 30, 2024, respectively, and included amortization of debt issuance costs
and debt discount of $ 181,000 and $ 537,000 , respectively. Interest expense related to the 2027 Notes totaled $ 1,375,000 and $ 4,141,000
for the three and nine months ended September 30, 2023, respectively, and included amortization of debt issuance costs and debt discount
of $ 180,000 and $ 556,000 , respectively.
HROWL
– 8.625% Senior Notes Due 2026
In
April and September 2021, the Company closed offerings (including an over-allotment exercise in May 2021) of $ 75,000,000
aggregate principal amount of 8.625 %
senior notes due April
2026 (the “2026 Notes”). In terest
expense related to the 2026 Notes totaled $ 1,814,000
and $ 5,438,000
for the three and nine
months ended September 30, 2024, respectively, and included amortization of debt issuance costs and debt discount of $ 197,000
and $ 587,000 ,
respectively. Interest expense related to the 2026 Notes totaled $ 1,814,000
and $ 5,436,000
for the three and nine
months ended September 30, 2023, respectively, and included amortization of debt issuance costs and debt discount of $ 197,000
and $ 585,000 ,
respectively.
A
summary of the Company’s debt is described as follows:
SCHEDULE OF LONG TERM DEBT
At
September 30,
At
December 31,
2024
2023
8.625 % Senior Notes due April 2026
$ 75,000,000
$ 75,000,000
11.875 % Senior Notes due December 2027
40,250,000
40,250,000
Oaktree Loan due January 2026
77,500,000
77,500,000
Notes payable gross
192,750,000
192,750,000
Less: Unamortized debt issuance costs, net of premium
( 6,693,000 )
( 9,578,000 )
Notes payable net
$ 186,057,000
$ 183,172,000
For
the three and nine months ended September 30, 2024, the total effective interest rate of the Company’s debt was 11.03 % and 11.17 %,
respectively, and 10.78 % and 10.91 % for the same periods in 2023, respectively .
16
At
September 30, 2024, future minimum payments under the Company’s debt were as follows:
SCHEDULE OF FUTURE MINIMUM PAYMENT UNDER NOTES PAYABLES
Amount
Remainder of 2024
$ 5,166,000
2025
20,560,000
2026
159,895,000
2027
45,030,000
Total minimum payments
230,651,000
Less: amount representing interest payments
( 37,901,000 )
Notes payable, gross principal amount due
192,750,000
Less: unamortized debt issuance costs, net of premium
( 6,693,000 )
Notes payable, net of unamortized debt issuance costs
$ 186,057,000
NOTE
12. LEASES
The
Company leases office and laboratory space under non-cancellable operating leases listed below. These lease agreements have remaining
terms between one to seven 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 38,153 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, 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, and another amendment entered
into in January 2024 that added 2,861 square feet of space.
●
An
operating lease for 5,500 square feet of office space in Nashville, Tennessee, which commenced in January 2020 and will expire in
December 2024 , with an option to extend the term for two additional five-year periods . The Company does not intend to exercise its
option to extend the term of this lease.
●
An
operating lease for 11,552 square feet of lab and office space in Nashville, Tennessee, which commenced in September 2022 and will
expire in September 2027 .
●
In
March 2024, the Company entered into an operating lease for 17,625 square feet of office space in Nashville, Tennessee that commenced
in August 2024 and has a seven -year term with an option to extend the term for two additional five-year periods . This office space
serves as the Company’s new corporate headquarters. Commensurate with the commencement date of the lease, the Company recognized
an operating right of use asset and liability of $ 2,853,000 .
At
September 30, 2024, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases
held by the Company were 7.85 % and 10.4 years, respectively.
During
the three and nine months ended September 30, 2024, cash paid for amounts included for the operating lease liabilities was $ 327,000 and
$ 972,000 , respectively, and $ 310,000 and $ 921,000 for the same periods in 2023, respectively. During the three and nine months ended
September 30, 2024, the Company recorded operating lease expense of $ 414,000 and $ 1,053,000 , respectively, and $ 309,000 and $ 926,000
for the same periods in 2023, respectively, which is included in selling, general and administrative expenses.
Future
lease payments under operating leases as of September 30, 2024 were as follows :
SCHEDULE
OF FUTURE LEASE PAYMENTS UNDER OPERATING LEASES
Operating Leases
Remainder of 2024
$ 329,000
2025
1,386,000
2026
1,767,000
2027
1,641,000
2028
1,342,000
Thereafter
7,971,000
Total minimum lease payments
14,436,000
Less: amount representing interest payments
( 4,429,000 )
Total operating lease obligations
10,007,000
Less: current portion, operating lease obligations
( 507,000 )
Operating lease obligations, net of current portion
$ 9,500,000
17
NOTE
13. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Common
Stock
During
the nine months ended September 30, 2024, the Company issued 141,628 shares of common stock and received proceeds of $ 1,005,000 upon the
exercise of options to purchase 141,628 shares of common stock with exercise prices ranging from $ 1.70 to $ 25.86 per share.
During
the nine months ended September 30, 2024, the Company issued 32,580
shares of common stock upon the cashless exercise of options to purchase 39,237
shares with exercise prices ranging from $ 1.70
to $ 8.00 per share.
During the nine months ended September 30, 2024, the Company issued 44,860
shares of common stock upon the cashless exercise of options to purchase 90,000 shares at an exercise price of $ 7.37 . The Company withheld
29,107 shares of common stock for payroll tax withholdings totaling $ 1,205,000 .
During
the nine months ended September 30, 2024, 45,000 RSUs granted in February 2021 to Andrew R. Boll, the Company’s Chief Financial
Officer, vested, and 26,520 shares of the Company’s common stock were issued to Mr. Boll, net of 18,480 shares of common stock
withheld for payroll tax withholdings totaling $ 197,000 .
During
the nine months ended September 30, 2024, 150,000 RSUs granted in February 2021 to Mark L. Baum, the Company’s Chief Executive
Officer, vested, and 90,164 shares of the Company’s common stock were issued to Mr. Baum, net of 59,836 shares of common stock
withheld for payroll tax withholdings totaling $ 638,000 .
During
the nine months ended September 30, 2024, 30,000 RSUs granted in February 2021 to John Saharek, the Company’s Chief Commercial
Officer, vested, and 17,384 shares of the Company’s common stock were issued to Mr. Saharek, net of 12,616 shares of common stock
withheld for payroll tax withholdings totaling $ 135,000 .
During
the nine months ended September 30, 2024, 50,000 RSUs granted in February 2021 to various other employees, vested, and 32,452 shares
of the Company’s common stock were issued, net of 17,548 shares of common stock withheld for payroll tax withholdings totaling
$ 187,000 .
During
the nine months ended September 30, 2024, the Company issued 57,517 shares of its common stock underlying RSUs held by directors that
ceased providing services to the Company. The RSUs had previously vested, including 3,872 RSUs that vested during the nine months ended
September 30, 2024, but the issuance and delivery of the shares were deferred until the director ceased providing services to the Company.
During
the nine months ended September 30, 2024, 34,008 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 directors cease providing services to the Company.
During the nine months ended September 30, 2024, 3,667 shares of the Company’s
common stock underlying RSUs issued to consultants vested, but the issuance and delivery of these shares has not occurred.
Stock
Option Plan
On
September 17, 2007, the Company’s Board of Directors and stockholders adopted the Company’s 2007 Incentive Stock and Awards
Plan, which was subsequently amended on November 5, 2008, February 26, 2012, July 18, 2012, May 2, 2013 and September 27, 2013 (as amended,
the “2007 Plan”). The 2007 Plan reached its term in September 2017, and we can no longer issue additional awards under this
plan, however, options previously issued under the 2007 Plan will remain outstanding until they are exercised, reach their maturity or
are otherwise cancelled/forfeited. On June 13, 2017, the Company’s Board of Directors and stockholders adopted the Company’s
2017 Incentive Stock and Awards Plan which was subsequently amended on June 3, 2021 (as amended, the “2017 Plan” together
with the 2007 Plan, the “Plans”). As of September 30, 2024, the 2017 Plan provides for the issuance of a maximum of 6,000,000
shares of the Company’s common stock. The purpose of the Plans are to attract and retain directors, officers, consultants, advisors
and employees whose services are considered valuable, to encourage a sense of proprietorship and to stimulate an active interest of such
persons in the Company’s development and financial success. Under the Plans, the Company is authorized to issue incentive stock
options intended to qualify under Section 422 of the Internal Revenue Code of 1986, as amended, non-qualified stock options, RSUs and
restricted stock. The Plans are administered by the Compensation Committee of the Company’s Board of Directors. The Company had
53,344 shares available for future issuances under the 2017 Plan at September 30, 2024.
18
Stock
Options
A
summary of stock option activity under the Plans for the nine months ended September 30, 2024 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, 2024
2,711,317
$ 6.25
Options granted
140,000
$ 14.72
Options exercised
( 270,865 )
$ 7.12
Options cancelled/forfeited
( 100,063 )
$ 13.56
Options outstanding – September 30, 2024
2,480,389
$ 6.33
3.44
$ 95,807,000
Options exercisable
2,218,148
$ 5.50
2.80
$ 87,536,000
Options vested and expected to vest
2,444,924
$ 6.21
3.36
$ 94,733,000
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 September 30, 2024, based on the closing price of the Company’s common stock of $ 44.96 on
that date.
During
the nine months ended September 30, 2024, 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 nine months ended September 30, 2024 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.
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
2024
Weighted-average
fair value of options granted
$ 9.64
Expected
terms (in years)
6.11
Expected
volatility
67.78 - 72.95 %
Risk-free
interest rate
3.72 - 4.48
%
Dividend
yield
-
The
following table summarizes information about stock options outstanding and exercisable at September 30, 2024:
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
- $ 1.70
31,942
2.96
$ 1.68
31,942
$ 1.68
$ 1.73
250,000
3.25
$ 1.73
250,000
$ 1.73
$ 2.23
270,000
2.34
$ 2.23
270,000
$ 2.23
$ 2.40
- $ 2.60
14,068
2.33
$ 2.57
14,068
$ 2.57
$ 3.95
308,500
1.50
$ 3.95
308,500
$ 3.95
$ 4.49
- $ 5.72
92,300
4.86
$ 5.53
92,300
$ 5.53
$ 6.30
285,000
4.39
$ 6.30
285,000
$ 6.30
$ 6.75
- $ 7.26
46,036
7.76
$ 6.85
18,162
$ 6.77
$ 7.30
274,500
5.26
$ 7.30
274,500
$ 7.30
$ 7.60
- $ 39.63
908,043
3.31
$ 9.63
673,676
$ 8.04
$ 1.47
- $ 39.63
2,480,389
3.44
$ 6.33
2,218,148
$ 5.50
19
As
of September 30, 2024, there was approximately $ 2,071,000 of total unrecognized compensation expense related to unvested stock options
granted under the Plans which is expected to be recognized over the weighted-average remaining vesting period of 2.83 years. The stock-based
compensation for all stock options was $ 160,000 and $ 416,000 during the three and nine months ended September 30, 2024, respectively,
and $ 154,000 and $ 617,000 during the same periods in 2023, respectively.
The
intrinsic value of options exercised during the nine months ended September 30, 2024 was $ 6,651,000 .
Restricted
Stock Units
RSU
awards are granted subject to certain vesting requirements and other restrictions, including time-based and performance-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.
A
summary of the Company’s RSU activity and related information for the nine months ended September 30, 2024 is as follows:
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY
Number of Shares
Weighted Average Grant Date Fair Value
RSUs unvested - January 1, 2024
363,029
$ 9.23
RSUs granted
319,081
23.93
RSUs vested
( 312,674 )
9.84
RSUs cancelled/forfeited
( 6,250 )
8.10
RSUs unvested - September 30, 2024
363,186
$ 21.63
As
of September 30, 2024, the total unrecognized compensation expense related to unvested RSUs was approximately $ 7,324,000 , which is expected
to be recognized over a weighted-average period of 2 years, based on estimated and actual vesting schedules of the applicable RSUs.
The stock-based compensation for RSUs during the three and nine months ended September 30, 2024 was $ 587,000 and $ 1,494,000 , respectively,
and was $ 374,000 and $ 789,000 during the same periods in 2023, respectively.
Performance
Stock Units (Market-Based Vesting)
A
summary of the Company’s PSU activity and related information for the nine months ended September 30, 2024 is as follows:
SCHEDULE OF PERFORMANCE STOCK UNITS ACTIVITY
Number of Shares
Weighted Average Grant Date Fair Value
PSUs unvested – January 1, 2024
1,567,913
$ 18.56
PSUs granted
-
PSUs vested
-
PSUs cancelled/forfeited
-
PSUs unvested – September 30, 2024
1,567,913
$ 18.56
20
As
of September 30, 2024, the total unrecognized compensation expense related to unvested PSUs was approximately $ 7,277,000 , which is expected
to be recognized over a weighted-average period of 0.51 years, based on estimated and actual vesting schedules of the applicable PSUs.
The stock-based compensation for PSUs during the three and nine months ended September 30, 2024 was $ 3,638,000 and $ 10,915,000 , respectively,
and $ 3,948,000 and $ 10,115,000 during the same periods in 2023, 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 AND CONSULTANTS
For
the Three Months Ended
September
30,
For
the Nine Months Ended
September
30,
2024
2023
2024
2023
Employees - selling, general and administrative
$ 3,728,000
$ 3,784,000
$ 10,832,000
$ 9,719,000
Employees - research and development
422,000
475,000
1,300,000
1,224,000
Directors - selling, general and administrative
199,000
200,000
601,000
528,000
Consultants - selling, general and administrative
36,000
17,000
92,000
50,000
Total
$ 4,385,000
$ 4,476,000
$ 12,825,000
$ 11,521,000
NOTE
14. 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 note.
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.
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 faces 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 note 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). Since July 2021, the complaint has been amended and
OSRX added counterclaims alleging ImprimisRx, LLC is violating the Lanham Act with false advertising. The Court granted cross
motions for summary judgement on each party’s Lanham Act claims thus leaving only ImprimisRx, LLC’s copyright
infringement, trademark infringement and unfair competition claims for trial. ImprimisRx, LLC is seeking damages from OSRX. The
trial associated with this matter began during the month of November 2024 and is ongoing as of the date of this Quarterly
Report.
21
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 charter 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. Several of the Company’s asset
purchase and license agreements contain customary representations, warranties, covenants and confidentiality provisions, and also contain
mutual indemnification obligations related primarily to performance under the respective agreements. 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.
Asset
Purchase, License and Related Agreements
FDA
Approved Product Acquisitions
In
recent years, the Company has acquired commercial and product rights to various FDA approved ophthalmic medications and products through
asset purchase, licenses, supply and/or other related agreements. In general, in exchange for product and commercial rights these agreements
provide the counterparties with certain upfront and contingent milestone payments typically related to certain annual sales amounts and
manufacturing events, and in certain cases, per unit transfer prices and royalties on sales of some of the products. During the three
and nine months ended September 30, 2024, $ 730,000
and $ 2,040,000 ,
respectively, were incurred under these agreements as royalty expenses, and $ 220,000
and $ 705,000 ,
respectively, during the same periods in 2023. During the three and nine months ended September 30, 2024, $ 0
was incurred under these agreements related to
upfront and milestone payments under these agreements. During the three and nine months ended September 30, 2023, the Company amended
the Sintetica Agreement to allow for early payment of previously accrued amounts for commercial related milestones associated with sales
of IHEEZO in exchange for a $ 550,000 reduction in the milestone amounts due, and as a result of this amendment, the Company reduced
the intangible asset value associated with IHEEZO by $ 550,000 and paid the remaining commercial milestone amount of $ 4,450,000 .
As of September 30, 2024, the remaining contingent consideration payable pursuant to these agreements were not considered probable
and reasonably estimable and therefore, no amount was accrued related to these contingent obligations during the three and nine months
ended September 30, 2024. At the time contingent consideration payable becomes probable and reasonably estimable the additional consideration,
if any, paid will be allocated to the assets based on their initial estimated fair values as a percent of the total purchase price.
Formulation
Acquisitions
The
Company has acquired and sourced intellectual property rights related to certain proprietary innovations from certain inventors, innovator
companies and related parties (the “Inventors”) through multiple asset purchase agreements and license 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 these intellectual property rights, the Company is obligated to make payments to the Inventors based
on the completion of a milestone, generally consisting of: (1) a payment payable within 30 to 45 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 nine months ended September 30, 2024, $ 453,000 and $ 949,000 , respectively, were incurred under these
agreements as royalty expenses and $ 300,000 and $ 951,000 , respectively, during the same periods in 2023.
22
Sales
and Marketing Agreements
The
Company has entered various sales and marketing agreements with certain organizations to provide exclusive and non-exclusive sales and
marketing representation services to Harrow in select geographies in the U.S. in connection with the Company’s ophthalmic pharmaceutical
compounded formulations or related products.
Under
the terms of the sales and marketing agreements, the Company was 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 was 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 nine months ended September 30, 2023, respectively.
Contract
Manufacturing
The
Company has entered into manufacturing agreements with respect to third-party contract manufacturers for its FDA approved pharmaceutical
products. Some of these contract manufacturing agreements require minimum annual order amounts. The Company has committed to pay approximately
$ 2,728,000 related to contract manufacturing agreements for the year ending December 31, 2024.
NOTE
15. SEGMENTS AND CONCENTRATIONS
Prior
to the three months ended September 30, 2024, the Company operated its business on the basis of a single reportable segment due to the
lack of discrete, precise financial information available to the chief operating decision maker (“CODM”). The CODM does not
review segment assets when assessing segment performance and deciding how to allocate resources. During the three months ended September
30, 2024, refinements were made to the financial reporting information and the Company began reporting on two reportable segments which
were generally determined based on the decision-making structure of the Company and the grouping of similar products and services: Branded
and ImprimisRx.
●
The
Branded segment includes activities of our FDA approved ophthalmology pharmaceutical products, including the out-licensing
of rights to certain of our branded products.
●
The
ImprimisRx segment represents activities in our ophthalmology-focused pharmaceutical compounding business.
Segment
contribution for the segments represents net revenues less cost of sales, certain general and administrative expenses, selling and marketing
expenses, and research and development expenses. The Company does not evaluate the following items at the segment level:
●
Selling,
general and administrative expenses that result from shared infrastructure, including certain expenses associated with legal matters,
public company costs (e.g. investor relations), board of directors and principal executive officers and other like shared expenses.
●
Operating
expenses within selling, general and administrative expenses that result from the impact of corporate initiatives. Corporate initiatives
primarily include integration, restructuring, acquisition and other shared costs.
●
Other
select revenues and operating expenses including research and development expenses, amortization, and asset sales and impairments, net as not all
such information has been accounted for at the segment level, or such information has not been used by all segments.
23
Segment
net revenues, segment operating expenses and segment contribution information consisted of the following:
SCHEDULE
OF SEGMENT NET REVENUES
Branded
ImprimisRx
Consolidated
Three Months Ended September 30, 2024
Branded
ImprimisRx
Consolidated
Product sales, net
$ 28,314,000
$ 20,705,000
$ 49,019,000
Other revenues
238,000
-
238,000
Total revenues
28,552,000
20,705,000
49,257,000
Cost of sales
( 5,169,000 )
( 6,849,000 )
( 12,018,000 )
Gross profit
23,383,000
13,856,000
37,239,000
Operating expenses:
Selling, general and administrative
14,038,000
5,427,000
19,465,000
Research and development
212,000
84,000
296,000
Segment contribution
$ 9,133,000
$ 8,345,000
17,478,000
Corporate
14,180,000
Research and development
1,977,000
Income from operations
$ 1,321,000
Branded
ImprimisRx
Consolidated
Three Months Ended September 30, 2023
Branded
ImprimisRx
Consolidated
Product sales, net
$ 12,040,000
$ 19,769,000
$ 31,809,000
Other revenues
2,456,000
-
2,456,000
Total revenues
14,496,000
19,769,000
34,265,000
Cost of sales
( 3,335,000 )
( 6,732,000 )
( 10,067,000 )
Gross profit
11,161,000
13,037,000
24,198,000
Operating expenses:
Selling, general and administrative
1,930,000
7,703,000
9,633,000
Research and development
37,000
159,000
196,000
Segment contribution
$ 9,194,000
$ 5,175,000
14,369,000
Corporate
11,400,000
Research and development
1,225,000
Income from operations
$ 1,744,000
Branded
ImprimisRx
Consolidated
Nine Months Ended September 30, 2024
Branded
ImprimisRx
Consolidated
Product sales, net
$ 69,395,000
$ 63,003,000
$ 132,398,000
Other revenues
385,000
-
385,000
Total revenues
69,780,000
63,003,000
132,783,000
Cost of sales
( 14,406,000 )
( 20,704,000 )
( 35,110,000 )
Gross profit
55,374,000
42,299,000
97,673,000
Operating expenses:
Selling, general and administrative
36,034,000
17,364,000
53,398,000
Research and development
321,000
261,000
582,000
Segment contribution
$ 19,019,000
$ 24,674,000
43,693,000
Corporate
40,877,000
Research and development
6,893,000
Loss from operations
$ ( 4,077,000 )
24
Branded
ImprimisRx
Consolidated
Nine Months Ended September 30, 2023
Branded
ImprimisRx
Consolidated
Product sales, net
$ 21,829,000
$ 59,975,000
$ 81,804,000
Other revenues
12,034,000
-
12,034,000
Total revenues
33,863,000
59,975,000
93,838,000
Cost of sales
( 8,396,000 )
( 19,942,000 )
( 28,338,000 )
Gross profit
25,467,000
40,033,000
65,500,000
Operating expenses:
Selling, general and administrative
4,797,000
23,334,000
28,131,000
Research and development
37,000
560,000
597,000
Segment contribution
$ 20,633,000
$ 16,139,000
36,772,000
Corporate
28,747,000
Research and development
2,719,000
Income from operations
$ 5,306,000
All
revenue is attributable to the United States. All long-lived assets at September 30, 2024 and December 31, 2023 were located in the United
States.
Revenues
by segment are further described as follows:
SCHEDULE
OF REVENUES BY SEGMENT
For the Three Months Ended
For the Nine Months Ended
September 30,
September 30,
2024
2023
2024
2023
IHEEZO
$ 12,882,000
26 %
$ 5,927,000
17 %
$ 26,498,000
20 %
$ 10,073,000
11 %
VEVYE
5,186,000
11 %
-
- %
12,099,000
9 %
-
- %
Other products (Anterior Segment)
10,256,000
21 %
6,605,000
19 %
30,808,000
23 %
13,205,000
14 %
Other revenue, net
228,000
0 %
1,964,000
6 %
375,000
0 %
10,585,000
11 %
Branded revenue, net
28,552,000
58 %
14,496,000
42 %
69,780,000
53 %
33,863,000
36 %
ImprimisRx revenue, net
20,705,000
42 %
19,769,000
58 %
63,003,000
47 %
59,975,000
64 %
Total revenues, net
$ 49,257,000
100 %
$ 34,265,000
100 %
$ 132,783,000
100 %
$ 93,838,000
100 %
Other
than IHEEZO, VEVYE, and one ImprimisRx product, no other products accounted for more than 10% of total revenues for the periods
presented.
Customer
and Supplier Concentrations
Substantially
all of the Company’s Branded sales are made to a third-party logistics wholesaler who sells the products to the end-user. There
were no customers who comprised more than 10 % of ImprimisRx revenues for the three and nine months ended September 30, 2024 and 2023.
25
As
of September 30, 2024 and December 31, 2023, accounts receivable from a single customer accounted for 64 % and 80 %, respectively, of
total consolidated accounts receivable. For the three and nine months ended September 30, 2024, revenues from a single customer accounted
for 46 % and 42 %, respectively, of total consolidated revenues. For the three and nine months ended September 30, 2023, revenues from
a single customer accounted for 35 % and 23 %, respectively, of total consolidated revenues.
The
Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 50 % and
51 % of active pharmaceutical ingredient purchases during the three and nine months ended September 30, 2024, respectively, and 96 % and
79 % during the same periods in 2023, respectively.
NOTE
16. SUBSEQUENT EVENTS
The
Company has performed an evaluation of events occurring subsequent to September 30, 2024 through the filing date of this Quarterly Report
on Form 10-Q. Based on its evaluation, no events other than those described below need to be disclosed.
In
October 2024, the Company entered into the Second Amendment to Credit Agreement and Guaranty with Oaktree (“Second Amendment”).
Upon satisfaction of certain conditions to funding, the Company drew down the principal amount of $ 30,000,000 (the “$ 30,000,000
Draw”) under a pre-existing commitment under the Oaktree Loan to partially fund a one-time milestone payment to Novartis Technology,
LLC and Novartis Innovative Therapies AG (together, “Novartis”). Under its asset purchase agreement with Novartis, the Company
made a one-time milestone payment to Novartis equal to $ 37,000,000 upon the commercial availability of TRIESENCE, which the Company paid
in October 2024. In connection with the Second Amendment, the Company incurred approximately $ 150,000 of costs. In connection with the
Second Amendment and following the $ 30,000,000 Draw, the Company has drawn down a total principal loan amount of $ 107,500,000 under the
Oaktree Loan and no additional principal loan amount remains available to the Company under the Oaktree Loan.
In November 2024, the Company became aware of a cybersecurity incident that involved unauthorized access of an employee’s
email account. Through this unauthorized access the threat actor was able to fraudulently divert Company funds to its bank account. The
Company, along with its external cybersecurity experts, is continuing to work diligently to fully investigate and assess the impact of
the incident and has notified, and is cooperating with, federal law enforcement. As the investigation of the incident is ongoing, the
full scope, nature and impact of the incident are not yet fully known.
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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.