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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, 2024
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,
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 7, 2024, there were 35,482,944 shares of the registrant’s common stock, $0.001 par value, outstanding.
HARROW,
INC.
Table
of Contents
PART
I
FINANCIAL
INFORMATION
Item
1. Financial Statements
HARROW,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 70,968,000 | | |
$ | 74,085,000 | |
Investment in Eton Pharmaceuticals | |
| - | | |
| 8,681,000 | |
Accounts receivable, net | |
| 51,988,000 | | |
| 36,261,000 | |
Inventories | |
| 9,425,000 | | |
| 10,867,000 | |
Prepaid expenses and other current assets | |
| 7,009,000 | | |
| 9,588,000 | |
Total current assets | |
| 139,390,000 | | |
| 139,482,000 | |
Property, plant and equipment, net | |
| 3,288,000 | | |
| 3,521,000 | |
Capitalized software costs, net | |
| 1,966,000 | | |
| 2,138,000 | |
Operating lease right-of-use assets, net | |
| 6,770,000 | | |
| 6,785,000 | |
Intangible assets, net | |
| 154,884,000 | | |
| 159,906,000 | |
Goodwill | |
| 332,000 | | |
| 332,000 | |
TOTAL ASSETS | |
$ | 306,630,000 | | |
$ | 312,164,000 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 22,264,000 | | |
$ | 24,581,000 | |
Accrued rebates and copay assistance | |
| 24,551,000 | | |
| 18,432,000 | |
Accrued payroll and related liabilities | |
| 5,721,000 | | |
| 5,450,000 | |
Deferred revenue and customer deposits | |
| 248,000 | | |
| 75,000 | |
Current portion of operating lease obligations | |
| 767,000 | | |
| 806,000 | |
Total current liabilities | |
| 53,551,000 | | |
| 49,344,000 | |
Operating lease obligations, net of current portion | |
| 6,543,000 | | |
| 6,524,000 | |
Accrued expenses, net of current portion | |
| 2,713,000 | | |
| 2,713,000 | |
Deferred tax liability | |
| 623,000 | | |
| - | |
Notes payable, net of unamortized debt discount | |
| 185,023,000 | | |
| 183,172,000 | |
TOTAL LIABILITIES | |
| 248,453,000 | | |
| 241,753,000 | |
Commitments and contingencies | |
| - | | |
| - | |
STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Common stock, $0.001 par value, 50,000,000 shares authorized, 35,479,492 and 35,168,260 shares issued
and outstanding at June 30, 2024 and December 31, 2023, respectively | |
| 35,000 | | |
| 35,000 | |
Additional paid-in capital | |
| 212,439,000 | | |
| 204,635,000 | |
Accumulated deficit | |
| (153,942,000 | ) | |
| (133,904,000 | ) |
TOTAL HARROW, INC. STOCKHOLDERS’ EQUITY | |
| 58,532,000 | | |
| 70,766,000 | |
Noncontrolling interests | |
| (355,000 | ) | |
| (355,000 | ) |
TOTAL STOCKHOLDERS’ EQUITY | |
| 58,177,000 | | |
| 70,411,000 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 306,630,000 | | |
$ | 312,164,000 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements
HARROW,
INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended | | |
For the Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenues: | |
| | | |
| | | |
| | | |
| | |
Product sales, net | |
$ | 48,871,000 | | |
$ | 29,542,000 | | |
$ | 83,379,000 | | |
$ | 49,995,000 | |
Other revenues | |
| 68,000 | | |
| 3,928,000 | | |
| 147,000 | | |
| 9,578,000 | |
Total revenues | |
| 48,939,000 | | |
| 33,470,000 | | |
| 83,526,000 | | |
| 59,573,000 | |
Cost of sales | |
| (12,539,000 | ) | |
| (10,000,000 | ) | |
| (23,092,000 | ) | |
| (18,271,000 | ) |
Gross profit | |
| 36,400,000 | | |
| 23,470,000 | | |
| 60,434,000 | | |
| 41,302,000 | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Selling, general and administrative | |
| 31,817,000 | | |
| 19,957,000 | | |
| 60,630,000 | | |
| 35,845,000 | |
Research and development | |
| 3,053,000 | | |
| 1,161,000 | | |
| 5,202,000 | | |
| 1,895,000 | |
Total operating expenses | |
| 34,870,000 | | |
| 21,118,000 | | |
| 65,832,000 | | |
| 37,740,000 | |
Income (loss) from operations | |
| 1,530,000 | | |
| 2,352,000 | | |
| (5,398,000 | ) | |
| 3,562,000 | |
Other (expense) income: | |
| | | |
| | | |
| | | |
| | |
Interest expense, net | |
| (5,471,000 | ) | |
| (5,704,000 | ) | |
| (10,886,000 | ) | |
| (10,451,000 | ) |
Investment (loss) gain from Eton Pharmaceuticals | |
| (1,923,000 | ) | |
| (714,000 | ) | |
| (3,171,000 | ) | |
| 1,328,000 | |
Loss on extinguishment of debt | |
| - | | |
| - | | |
| - | | |
| (5,465,000 | ) |
Other income (expenses), net | |
| 46,000 | | |
| (178,000 | ) | |
| 72,000 | | |
| (149,000 | ) |
Total other expense, net | |
| (7,348,000 | ) | |
| (6,596,000 | ) | |
| (13,985,000 | ) | |
| (14,737,000 | ) |
Income tax (expense) benefit | |
| (655,000 | ) | |
| 15,000 | | |
| (655,000 | ) | |
| 303,000 | |
Net loss | |
$ | (6,473,000 | ) | |
$ | (4,229,000 | ) | |
$ | (20,038,000 | ) | |
$ | (10,872,000 | ) |
Basic and diluted net loss per share of common stock | |
$ | (0.18 | ) | |
$ | (0.14 | ) | |
$ | (0.56 | ) | |
$ | (0.36 | ) |
Weighted average number of shares of common stock outstanding, basic and diluted | |
| 35,618,977 | | |
| 30,458,677 | | |
| 35,544,312 | | |
| 30,379,354 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
HARROW,
INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
For
the periods ended June 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: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
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 and PSUs | |
| 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 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
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 | |
| 87,195 | | |
| - | | |
| 521,000 | | |
| - | | |
| 521,000 | | |
| - | | |
| 521,000 | |
Vesting of RSUs | |
| 332,517 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Shares withheld related to net share settlement of equity awards | |
| (108,480 | ) | |
| - | | |
| (1,157,000 | ) | |
| - | | |
| (1,157,000 | ) | |
| - | | |
| (1,157,000 | ) |
Stock-based compensation expense | |
| - | | |
| - | | |
| 8,440,000 | | |
| - | | |
| 8,440,000 | | |
| - | | |
| 8,440,000 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (20,038,000 | ) | |
| (20,038,000 | ) | |
| - | | |
| (20,038,000 | ) |
Balance at June 30, 2024 | |
| 35,479,492 | | |
$ | 35,000 | | |
$ | 212,439,000 | | |
$ | (153,942,000 | ) | |
$ | 58,532,000 | | |
$ | (355,000 | ) | |
$ | 58,177,000 | |
| |
Shares | | |
Value | | |
Capital | | |
Deficit | | |
Equity | | |
Equity | | |
Equity | |
| |
| | |
| | |
| | |
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 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 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at March 31, 2024 | |
| 35,380,955 | | |
$ | 35,000 | | |
$ | 207,995,000 | | |
$ | (147,469,000 | ) | |
$ | 60,561,000 | | |
$ | (355,000 | ) | |
$ | 60,206,000 | |
Balance | |
| 35,380,955 | | |
$ | 35,000 | | |
$ | 207,995,000 | | |
$ | (147,469,000 | ) | |
$ | 60,561,000 | | |
$ | (355,000 | ) | |
$ | 60,206,000 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Issuance of common stock in connection with: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Exercise of employee stock-based options | |
| 41,020 | | |
| - | | |
| 173,000 | | |
| - | | |
| 173,000 | | |
| - | | |
| 173,000 | |
Vesting of RSUs | |
| 57,517 | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Stock-based compensation expense | |
| - | | |
| - | | |
| 4,271,000 | | |
| - | | |
| 4,271,000 | | |
| - | | |
| 4,271,000 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| (6,473,000 | ) | |
| (6,473,000 | ) | |
| - | | |
| (6,473,000 | ) |
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 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
HARROW,
INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
| |
| | |
| |
| |
For the Six Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
CASH FLOWS FROM OPERATING ACTIVITIES | |
| | | |
| | |
Net loss | |
$ | (20,038,000 | ) | |
$ | (10,872,000 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization of property, plant and equipment and software development costs | |
| 885,000 | | |
| 690,000 | |
Amortization of intangible assets | |
| 5,103,000 | | |
| 5,050,000 | |
Amortization of operating lease right-of-use assets | |
| 392,000 | | |
| 357,000 | |
(Recovery of) provision for credit losses | |
| (96,000 | ) | |
| 29,000 | |
Amortization of debt issuance costs and debt discount | |
| 1,951,000 | | |
| 1,623,000 | |
Investment loss (gain) from investment in Eton | |
| 3,171,000 | | |
| (1,328,000 | ) |
Loss on extinguishment of debt | |
| - | | |
| 5,465,000 | |
Stock-based compensation | |
| 8,440,000 | | |
| 7,045,000 | |
Deferred income tax | |
| 623,000 | | |
| (288,000 | ) |
Changes in assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (15,631,000 | ) | |
| (12,038,000 | ) |
Inventories | |
| 1,442,000 | | |
| (2,014,000 | ) |
Prepaid expenses and other current assets | |
| 2,579,000 | | |
| (201,000 | ) |
Accounts payable, accrued expenses, accrued rebates and copay assistance | |
| 3,361,000 | | |
| 3,584,000 | |
Accrued payroll and related liabilities | |
| 271,000 | | |
| (769,000 | ) |
Deferred revenue and customer deposits | |
| 173,000 | | |
| 19,000 | |
NET CASH USED IN OPERATING ACTIVITIES | |
| (7,374,000 | ) | |
| (3,648,000 | ) |
CASH FLOWS FROM INVESTING ACTIVITIES | |
| | | |
| | |
Net proceeds on sale of Eton Pharmaceuticals | |
| 5,510,000 | | |
| - | |
Investment in patent and trademark assets | |
| (81,000 | ) | |
| - | |
Purchase of product NDAs and related patents | |
| - | | |
| (131,473,000 | ) |
Purchases of property, plant and equipment | |
| (436,000 | ) | |
| (746,000 | ) |
NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES | |
| 4,993,000 | | |
| (132,219,000 | ) |
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 debt issuance costs | |
| (100,000 | ) | |
| - | |
Payment of payroll taxes upon vesting of PSUs, RSUs and exercise of stock options | |
| (1,157,000 | ) | |
| (661,000 | ) |
Proceeds from exercise of stock options | |
| 521,000 | | |
| 337,000 | |
Proceeds from B. Riley senior secured note, net of costs | |
| - | | |
| 55,879,000 | |
Repayment of B. Riley senior secured note | |
| - | | |
| (59,750,000 | ) |
NET CASH (USED IN) PROVIDED BY FINANCING ACTIVITIES | |
| (736,000 | ) | |
| 62,351,000 | |
NET CHANGE IN CASH AND CASH EQUIVALENTS | |
| (3,117,000 | ) | |
| (73,516,000 | ) |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | |
| 74,085,000 | | |
| 96,270,000 | |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | |
$ | 70,968,000 | | |
$ | 22,754,000 | |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: | |
| | | |
| | |
Cash paid for income taxes | |
$ | - | | |
$ | 4,000 | |
Cash paid for interest | |
$ | 10,316,000 | | |
$ | 8,076,000 | |
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 | |
$ | - | | |
$ | 2,275,000 | |
Purchase of property, plant and equipment included in | |
| | | |
| | |
accounts payable and accrued expenses | |
$ | 44,000 | | |
$ | 115,000 | |
Purchase of property, plant and equipment included in
accounts payable and accrued expenses | |
$ | 44,000 | | |
$ | 115,000 | |
Right-of-use assets obtained in exchange for new operating lease obligations | |
$ | 377,000 | | |
$ | - | |
Income taxes owed for exercise of options | |
$ | - | | |
$ | 1,037,000 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
HARROW,
INC.
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
the Three and Six Months Ended June 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 six months ended June
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 six months ended June 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.
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.
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, 2024 was $52,727,000, net of $235,000
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, 2024:
SCHEDULE
OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS
Balance at January 1, 2024 | |
$ | 371,000 | |
Change in expected credit losses | |
| (96,000 | ) |
Write-offs, net of recoveries | |
| (40,000 | ) |
Balance at June 30, 2024 | |
$ | 235,000 | |
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 1,982,000 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.
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
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
Carrying Value | | |
Fair Value | | |
Carrying Value | | |
Fair Value | |
2026 Notes | |
$ | 73,607,000 | | |
$ | 76,470,000 | | |
$ | 73,218,000 | | |
$ | 70,260,000 | |
2027 Notes | |
$ | 37,770,000 | | |
$ | 43,019,000 | | |
$ | 37,413,000 | | |
$ | 40,363,000 | |
Oaktree Loan | |
$ | 73,646,000 | | |
$ | 77,500,000 | | |
$ | 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, 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 4,488,940 and 6,131,026
at June 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 June 30, 2024 and 2023 was 181,038 and 234,027, 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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended June 30, | | |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Numerator – net loss | |
$ | (6,473,000 | ) | |
$ | (4,229,000 | ) | |
$ | (20,038,000 | ) | |
$ | (10,872,000 | ) |
Denominator – weighted average number of shares outstanding, basic and diluted | |
| 35,618,977 | | |
| 30,458,677 | | |
| 35,544,312 | | |
| 30,379,354 | |
Net loss per share, basic and diluted | |
$ | (0.18 | ) | |
$ | (0.14 | ) | |
$ | (0.56 | ) | |
$ | (0.36 | ) |
Income
Taxes
The
Company’s effective tax rate was 3.38% and (2.71)% for the six months ended June 30, 2024 and 2023, respectively. The Company’s
effective tax rate for the six months ended June 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 (“IRC”), Section 162(m) excess
officer compensation limitation and share-based compensation and the change in valuation allowance.
As
of June 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 June 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 June 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 June 30, 2024
In
August 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-05,
Business Combinations—Joint Venture Formations (Subtopic 805-60): Recognition and Initial Measurement, which applies to
the formation of entities that meet the definition of a joint venture (or a corporate joint venture) and requires joint ventures to initially
measure all contributions received upon formation at fair value. The new guidance does not impact accounting by the venturers. The new
guidance is applicable to joint venture entities with a formation date on or after January 1, 2025 on a prospective basis. Joint ventures
formed prior to the effective date may elect to apply the new guidance retrospectively back to their original formation date. The Company
will apply the guidance in ASU 2023-05 prospectively to any future arrangements meeting the definition of a joint venture.
In
October 2023, FASB issued 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
in 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.
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 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, 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.
Intellectual
Property License and Related Arrangements Revenues
As
of June 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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended | | |
For the Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Product sales, net | |
$ | 48,871,000 | | |
$ | 29,542,000 | | |
$ | 83,379,000 | | |
$ | 49,995,000 | |
Other revenues | |
| 68,000 | | |
| 3,928,000 | | |
| 147,000 | | |
| 9,578,000 | |
Total revenues | |
$ | 48,939,000 | | |
$ | 33,470,000 | | |
$ | 83,526,000 | | |
$ | 59,573,000 | |
Deferred
revenue and customer deposits at June 30, 2024 and December 31, 2023 were $248,000 and $75,000, respectively. All deferred revenue and
customer deposit amounts at December 31, 2023 were recognized as revenue during the six months ended June 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 six months ended June 30, 2024, the Company did not record
any reimbursable expenses and amounts payable by Melt pursuant to the Melts MSA. During the three and six months ended June 30,
2023, the Company recorded $30,000
and $40,000
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 each of June 30, 2024 and
December 31, 2023, the Company was due $228,000
from Melt for reimbursable expenses and amounts payable under the Melt MSA.
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
| |
2024 | | |
2023 | |
| |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Revenues, net | |
$ | - | | |
$ | - | |
Loss from operations | |
$ | (5,631,000 | ) | |
$ | (2,448,000 | ) |
Net loss | |
$ | (5,344,000 | ) | |
$ | (3,551,000 | ) |
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE
OF CONDENSED BALANCE SHEET
| |
2024 | | |
2023 | |
| |
At June 30, | | |
At December 31, | |
| |
2024 | | |
2023 | |
Current assets | |
$ | 11,284,000 | | |
$ | 13,404,000 | |
Non-current assets | |
| - | | |
| - | |
Total assets | |
$ | 11,284,000 | | |
$ | 13,404,000 | |
| |
| | | |
| | |
Total liabilities | |
$ | 3,794,000 | | |
$ | 3,922,000 | |
Total stockholders’ equity | |
| 7,490,000 | | |
| 9,482,000 | |
Total liabilities and stockholders’ equity | |
$ | 11,284,000 | | |
$ | 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 June 30,
2024 | | |
At December 31,
2023 | |
Raw materials | |
$ | 4,964,000 | | |
$ | 5,477,000 | |
Work in progress | |
| 137,000 | | |
| 54,000 | |
Finished goods | |
| 4,324,000 | | |
| 5,336,000 | |
Total inventories | |
$ | 9,425,000 | | |
$ | 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 June 30,
2024 | | |
At December 31,
2023 | |
Prepaid insurance | |
$ | 306,000 | | |
$ | 1,241,000 | |
Prepaid computer software licenses and related expenses | |
| 952,000 | | |
| 963,000 | |
Other prepaid expenses | |
| 2,470,000 | | |
| 1,556,000 | |
Receivable due from Melt | |
| 228,000 | | |
| 228,000 | |
Prepaid FY 2024 Prescription Drug User (“PDUFA”) fees | |
| 1,146,000 | | |
| 3,438,000 | |
Deferred Oaktree Loan commitment fee | |
| 454,000 | | |
| 409,000 | |
Deposits and other current assets | |
| 1,453,000 | | |
| 1,753,000 | |
Total prepaid expenses and other current assets | |
$ | 7,009,000 | | |
$ | 9,588,000 | |
NOTE
7. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment consisted of the following:
SCHEDULE
OF PROPERTY, PLANT AND EQUIPMENT
| |
At June 30,
2024 | | |
At December 31,
2023 | |
Property, plant and equipment, net: | |
| | | |
| | |
Computer hardware | |
$ | 1,434,000 | | |
$ | 1,322,000 | |
Furniture and equipment | |
| 942,000 | | |
| 936,000 | |
Lab and pharmacy equipment | |
| 4,737,000 | | |
| 4,564,000 | |
Leasehold improvements | |
| 6,844,000 | | |
| 6,771,000 | |
Property, plant and equipment, gross | |
| 13,957,000 | | |
| 13,593,000 | |
Accumulated depreciation | |
| (10,669,000 | ) | |
| (10,072,000 | ) |
Property, plant and equipment,
net | |
$ | 3,288,000 | | |
$ | 3,521,000 | |
For
the three and six months ended June 30, 2024, depreciation related to property, plant and equipment was $301,000 and $597,000, respectively,
compared to $228,000 and $453,000 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 June 30,
2024 | | |
At December 31,
2023 | |
Capitalized software costs | |
| | | |
| | |
Capitalized internal-use software development costs | |
$ | 3,318,000 | | |
$ | 2,780,000 | |
Acquired third-party software license for internal-use | |
| 204,000 | | |
| 159,000 | |
Total gross capitalized software for internal-use | |
| 3,522,000 | | |
| 2,939,000 | |
Accumulated amortization | |
| (1,556,000 | ) | |
| (1,268,000 | ) |
Capitalized internal-use software in process | |
| - | | |
| 467,000 | |
Total capitalized software
costs net | |
$ | 1,966,000 | | |
$ | 2,138,000 | |
The
Company recorded amortization expense of $152,000 and $288,000 related to capitalized software costs during the three and six months
ended June 30, 2024, respectively, and $170,000 and $237,000 during the same periods in 2023, respectively.
NOTE
9. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at June 30, 2024 consisted of the following:
SCHEDULE OF INTANGIBLE ASSETS
| |
Amortization Periods (in years) | |
Cost | | |
Accumulated Amortization | | |
Disposal | | |
Net Carrying Value | |
Patents | |
7-19 | |
$ | 610,000 | | |
$ | (188,000 | ) | |
$ | - | | |
$ | 422,000 | |
Licenses | |
7-20 | |
| 50,000 | | |
| (2,000 | ) | |
| - | | |
| 48,000 | |
Trademarks | |
Indefinite | |
| 234,000 | | |
| - | | |
| - | | |
| 234,000 | |
Acquired NDAs | |
4-15 | |
| 170,398,000 | | |
| (16,352,000 | ) | |
| - | | |
| 154,046,000 | |
Customer relationships | |
3-15 | |
| 596,000 | | |
| (536,000 | ) | |
| - | | |
| 60,000 | |
Trade name | |
5 | |
| 75,000 | | |
| (6,000 | ) | |
| - | | |
| 69,000 | |
Non-competition clause | |
3-4 | |
| 50,000 | | |
| (50,000 | ) | |
| - | | |
| - | |
State pharmacy licenses | |
25 | |
| 8,000 | | |
| (3,000 | ) | |
| - | | |
| 5,000 | |
| |
| |
$ | 172,021,000 | | |
$ | (17,137,000 | ) | |
$ | - | | |
$ | 154,884,000 | |
Amortization
expense for intangible assets was as follows:
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended | | |
For the Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Patents | |
$ | 14,000 | | |
$ | 21,000 | | |
$ | 28,000 | | |
$ | 43,000 | |
Licenses | |
| - | | |
| 3,000 | | |
| - | | |
| 5,000 | |
Acquired NDAs | |
| 2,529,000 | | |
| 2,805,000 | | |
| 5,059,000 | | |
| 4,975,000 | |
Customer relationships | |
| 6,000 | | |
| 14,000 | | |
| 16,000 | | |
| 27,000 | |
Amortization
expense of intangible assets | |
$ | 2,549,000 | | |
$ | 2,843,000 | | |
$ | 5,103,000 | | |
$ | 5,050,000 | |
Estimated
future amortization expenses for the Company’s intangible assets at June 30, 2024 was as follows:
SCHEDULE
OF ESTIMATED FUTURE AMORTIZATION EXPENSE
| |
| | |
Remainder of 2024 | |
$ | 5,098,000 | |
2025 | |
| 13,658,000 | |
2026 | |
| 13,658,000 | |
2027 | |
| 13,309,000 | |
2028 | |
| 12,961,000 | |
Thereafter | |
| 95,966,000 | |
Intangible
assets | |
$ | 154,650,000 | |
There
were no changes to the carrying value of the Company’s goodwill during the three and six months ended June 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 June 30, | | |
At December 31, | |
| |
2024 | | |
2023 | |
Accounts payable | |
$ | 20,177,000 | | |
$ | 21,424,000 | |
Accrued insurance premium | |
| - | | |
| 873,000 | |
Other accrued payments | |
| 106,000 | | |
| 306,000 | |
Accrued interest (see Note 11) | |
| 1,981,000 | | |
| 1,978,000 | |
Accrued exit fee for Oaktree Loan (see Note 11) | |
| 2,713,000 | | |
| 2,713,000 | |
Total accounts payable and accrued expenses | |
$ | 24,977,000 | | |
$ | 27,294,000 | |
Less: current portion | |
| (22,264,000 | ) | |
| (24,581,000 | ) |
Non-current total accrued expenses | |
$ | 2,713,000 | | |
$ | 2,713,000 | |
The
Company financed insurance policies for the policy terms of August 2023 through August 2024. The financing agreement had an interest
rate of 7.48% per annum and required nine monthly payments of $150,000 all of which had been paid as of June 30, 2024.
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 (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. 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 “Oaktree Amendment”). Under the Oaktree 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”) is 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 $2,944,000 and $5,897,000 for the three and six months ended June 30, 2024, respectively,
and included the amortization of debt issuance costs and discount of $602,000 and $1,205,000, respectively. 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.
The
Oaktree Loan carries an exit fee equal to 3.5% of the aggregate principal amount owed, payable at maturity. As of June 30, 2024 and December
31, 2023, the Company had recorded in accrued expenses the total exit fee liability of $2,713,000.
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 $1,373,000 and $2,746,000 for the three and six
months ended June 30, 2024, respectively, and included amortization of debt issuance costs and debt discount of $178,000 and $356,000,
respectively. 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.
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”). Interest expense related to the 2026 Notes totaled $1,812,000
and $3,624,000 for the three and six months ended June 30, 2024, respectively, and included amortization of debt issuance costs and debt
discount of $195,000 and $390,000, respectively. Interest expense related to the 2026 Notes totaled $1,812,000 and $3,622,000 for the
three and six months ended June 30, 2023, respectively, and included amortization of debt issuance costs and debt discount of $195,000
and $388,000, respectively.
A
summary of the Company’s debt is described as follows:
SCHEDULE OF LONG TERM DEBT
| |
At June 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 | |
| (7,727,000 | ) | |
| (9,578,000 | ) |
Notes payable net | |
$ | 185,023,000 | | |
$ | 183,172,000 | |
For
the three and six months ended June 30, 2024, the total effective interest rate of the Company’s debt was 10.78% and 10.88%, respectively,
and 10.71% and 10.81% for the same periods in 2023, respectively.
At
June 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 | |
$ | 10,674,000 | |
2025 | |
| 20,658,000 | |
2026 | |
| 159,899,000 | |
2027 | |
| 45,030,000 | |
Total minimum payments | |
| 236,261,000 | |
Less: amount representing interest payments | |
| (43,511,000 | ) |
Notes payable, gross principal amount due | |
| 192,750,000 | |
Less: unamortized debt issuance costs, net of premium | |
| (7,727,000 | ) |
Notes payable, net of unamortized debt issuance costs | |
$ | 185,023,000 | |
NOTE
12. LEASES
The
Company leases office and laboratory space under non-cancelable 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 which is expected to
commence in August 2024 and has a term (target expiration date of June 30, 2032) with an option to extend the term for
two additional five-year periods. Once occupied, the Company expects this office space to serve as the Company’s new corporate
headquarters. Any operating lease right-of-use assets and liabilities related to this lease will be recognized at its commencement
date. |
At
June 30, 2024, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases
held by the Company were 6.60% and 11.2 years, respectively.
During
the three and six months ended June 30, 2024, cash paid for amounts included for the operating lease liabilities was $327,000 and $650,000,
respectively, and $306,000 and $611,000 for the same periods in 2023, respectively. During the three and six months ended June 30, 2024,
the Company recorded operating lease expense of $319,000 and $638,000, respectively, and $308,000 and $617,000 for the same periods in
2023, respectively, which is included in selling, general and administrative expenses.
Future
lease payments under operating leases as of June 30, 2024 were as follows:
SCHEDULE
OF FUTURE LEASE PAYMENTS UNDER OPERATING LEASES
| |
Operating Leases | |
Remainder of 2024 | |
$ | 655,000 | |
2025 | |
| 1,133,000 | |
2026 | |
| 1,155,000 | |
2027 | |
| 1,014,000 | |
2028 | |
| 699,000 | |
Thereafter | |
| 5,533,000 | |
Total minimum lease payments | |
| 10,189,000 | |
Less: amount representing interest payments | |
| (2,879,000 | ) |
Total operating lease obligations | |
| 7,310,000 | |
Less: current portion, operating lease obligations | |
| (767,000 | ) |
Operating lease obligations, net of current portion | |
$ | 6,543,000 | |
NOTE
13. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Common
Stock
During
the six months ended June 30, 2024, the Company issued 86,996 shares of common stock and received proceeds of $521,000 upon the exercise
of options to purchase 86,996 shares of common stock with exercise prices ranging from $1.70 to $12.38 per share.
During
the six months ended June 30, 2024, the Company issued 199 shares of common stock upon the cashless exercise of options to purchase 700
shares at an exercise price of $7.60 per share.
During
the six months ended June 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 six months ended June 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 six months ended June 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 six months ended June 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 six months ended June 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 six months ended June
30, 2024, but the issuance and delivery of the shares were deferred until the director ceased providing services to the Company.
During
the six months ended June 30, 2024, 23,016 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.
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, 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
173,219 shares available for future issuances under the 2017 Plan at June 30, 2024.
Stock
Options
A
summary of stock option activity under the Plans for the six months ended June 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 | |
| 105,500 | | |
$ | 10.13 | | |
| | | |
| | |
Options exercised | |
| (87,696 | ) | |
$ | 6.02 | | |
| | | |
| | |
Options cancelled/forfeited | |
| (79,938 | ) | |
$ | 13.95 | | |
| | | |
| | |
Options outstanding – June 30, 2024 | |
| 2,649,183 | | |
$ | 6.18 | | |
| 3.62 | | |
$ | 39,021,000 | |
Options exercisable | |
| 2,382,865 | | |
$ | 5.62 | | |
| 3.03 | | |
$ | 36,398,000 | |
Options vested and expected to vest | |
| 2,612,254 | | |
$ | 6.10 | | |
| 3.54 | | |
$ | 38,667,000 | |
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 28, 2024, based on the closing price of the Company’s common stock of $20.89 on that
date.
During
the six months ended June 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 six months ended June 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. 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
| |
2024 | |
Weighted-average fair value of options granted | |
$ | 6.57 | |
Expected terms (in years) | |
| 6.11 | |
Expected volatility | |
| 68 | % |
Risk-free interest rate | |
| 4.06-4.48 | % |
Dividend yield | |
| - | |
The
following table summarizes information about stock options outstanding and exercisable at June 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 - $1.73 | |
| 287,852 | | |
| 3.47 | | |
$ | 1.72 | | |
| 287,852 | | |
$ | 1.72 | |
$2.23 | |
| 270,000 | | |
| 2.59 | | |
$ | 2.23 | | |
| 270,000 | | |
$ | 2.23 | |
$2.40 - $2.60 | |
| 23,068 | | |
| 2.51 | | |
$ | 2.58 | | |
| 23,068 | | |
$ | 2.58 | |
$3.95 | |
| 308,500 | | |
| 1.75 | | |
$ | 3.95 | | |
| 308,500 | | |
$ | 3.95 | |
$4.49 - $5.72 | |
| 99,912 | | |
| 4.97 | | |
$ | 5.54 | | |
| 97,978 | | |
$ | 5.53 | |
$6.30 | |
| 285,000 | | |
| 4.64 | | |
$ | 6.30 | | |
| 285,000 | | |
$ | 6.30 | |
$6.75 - $7.26 | |
| 58,406 | | |
| 7.90 | | |
$ | 6.92 | | |
| 26,566 | | |
$ | 6.93 | |
$7.30 | |
| 274,500 | | |
| 5.51 | | |
$ | 7.30 | | |
| 274,500 | | |
$ | 7.30 | |
$7.37 - $7.79 | |
| 191,210 | | |
| 3.68 | | |
$ | 7.50 | | |
| 149,534 | | |
$ | 7.47 | |
$7.87 - $25.86 | |
| 850,735 | | |
| 3.27 | | |
$ | 9.17 | | |
| 659,867 | | |
$ | 8.14 | |
$1.47 - $25.86 | |
| 2,649,183 | | |
| 3.62 | | |
$ | 6.18 | | |
| 2,382,865 | | |
$ | 5.62 | |
As
of June 30, 2024, there was approximately $1,723,000 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 $130,000 and $256,000 during the three and six months ended June 30, 2024, respectively, and $122,000
and $463,000 during the same periods in 2023, respectively.
The
intrinsic value of options exercised during the six months ended June 30, 2024 was $694,000.
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 six months ended June 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 | |
| 213,081 | | |
| 17.22 | |
RSUs vested | |
| (298,016 | ) | |
| 9.51 | |
RSUs cancelled/forfeited | |
| (6,250 | ) | |
| 8.10 | |
RSUs unvested - June 30, 2024 | |
| 271,844 | | |
$ | 15.21 | |
As
of June 30, 2024, the total unrecognized compensation expense related to unvested RSUs was approximately $3,945,000, which is expected
to be recognized over a weighted-average period of 2.2 years, based on estimated and actual vesting schedules of the applicable RSUs.
The stock-based compensation for RSUs during the three and six months ended June 30, 2024 was $502,000 and $907,000, respectively, and
was $122,000 and $463,000 during the same periods in 2023, respectively.
Performance
Stock Units
A
summary of the Company’s PSU activity and related information for the six months ended June 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 – June 30, 2024 | |
| 1,567,913 | | |
$ | 18.56 | |
As
of June 30, 2024, the total unrecognized compensation expense related to unvested PSUs was approximately $14,553,000, which is expected
to be recognized over a weighted-average period of 0.76 years, based on estimated and actual vesting schedules of the applicable PSUs.
The stock-based compensation for PSUs during the three and six months ended June 30, 2024 was $3,638,000 and $7,276,000, respectively,
and $5,290,000 and $6,582,000 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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended June 30, | | |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Employees - selling, general and administrative | |
$ | 3,579,000 | | |
$ | 4,607,000 | | |
$ | 7,104,000 | | |
$ | 5,935,000 | |
Employees - research and development | |
| 439,000 | | |
| 586,000 | | |
| 878,000 | | |
| 749,000 | |
Directors - selling, general and administrative | |
| 214,000 | | |
| 203,000 | | |
| 402,000 | | |
| 328,000 | |
Consultants - selling, general and administrative | |
| 39,000 | | |
| 16,000 | | |
| 56,000 | | |
| 33,000 | |
Total | |
$ | 4,271,000 | | |
$ | 5,412,000 | | |
$ | 8,440,000 | | |
$ | 7,045,000 | |
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 matter was expected to go to trial in August 2024, however, due to scheduling
conflicts with the Court, the trial will be re-scheduled to a later date that has not yet been determined.
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 six months ended June 30, 2024, $1,036,000
and $1,310,000,
respectively, were incurred under these agreements as royalty expenses, and $0
and $0, respectively,
during the same periods in 2023. During the three and six months ended June 30, 2024, $0
were incurred under these agreements related to upfront and milestone payments under these agreements, respectively, and $0
and $5,000,000, respectively,
during the same periods in 2023. As of June 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 six months ended June 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 certain milestones, 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 six months ended June 30, 2024, $316,000 and $496,000, respectively, were incurred under these agreements as royalty
expenses and $275,000 and $651,000, respectively, during the same periods in 2023.
Sales
and Marketing Agreements
The
Company had 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 six months ended June 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
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. An operating segment is defined as a component of an entity that engages in business activities from which it may
recognize revenues and incur expense, its operating results are regularly reviewed by the entity’s chief operating decision maker
(“CODM”) to make decisions about resources to be allocated to the segment and assess its performance, and its discrete financial
information is available. The Company’s CODM, who is the Chief Executive Officer, evaluates
the Company as a single operating segment, consistent with internal management reporting.
The
Company had one product that accounted for more than 10% of total revenues during the three and six months ended June 30, 2024. The Company had 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.
These products collectively accounted for 23% and 14% of revenues during the three and six months ended June 30, 2024, respectively.
For the same periods in the prior year these products collectively accounted for 48% and 38% of revenues during the three and six months
ended June 30, 2023.
As
of June 30, 2024 and December 31, 2023, accounts receivable from a single customer accounted for 67%
and 80%
of total accounts receivable, respectively. For the three and six months ended June 30, 2024, revenues from a single customer
accounted for 45%
and 40% of total revenues, 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.
The
Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 61%
and 62% of active pharmaceutical ingredient purchases during the three and six months ended June 30, 2024, respectively, and 80%
and 85%
during the same periods in 2023, respectively.
NOTE
16. SUBSEQUENT EVENTS
The
Company has performed an evaluation of events occurring subsequent to June 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
July 2024, the Company issued 2,563
shares of common stock and received proceeds of $53,000
upon the exercise of options to purchase 2,563
shares of common stock with exercise prices between $7.60 and $20.97
per share.
In July 2024, the Company issued 889 shares of common stock upon the cashless exercise of options to purchase 1,000
shares at an exercise price of $2.60 per share.
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, 2023 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, Inc. and its consolidated subsidiaries, including ImprimisRx, LLC, ImprimisRx
NJ, LLC dba ImprimisRx, Imprimis NJOF, LLC, Harrow IP, 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 North America, all of which are marketed under
the Harrow name. We also own and operate ImprimisRx, one of the nation’s leading ophthalmology-focused pharmaceutical-compounding
businesses.
Factors
Affecting Our Performance
We
believe the primary factors affecting our performance are (1) our ability to increase revenues of our branded pharmaceutical products,
proprietary compounded formulations and certain non-proprietary products, and grow and gain operating efficiencies in our operations,
(2) potential and ongoing regulatory-related restrictions, (3) our ability to 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.
Recent
Developments
The
following is a summary of selected significant developments affecting our business that occurred since December 31, 2023. For additional
developments, see our Annual Report on Form 10-K for the year ended December 31, 2023.
TRIESENCE
PPQ Batches and Manufacturing
In
June 2024, we announced the successful manufacture of a process performance qualification (“PPQ”) batch of TRIESENCE. In
order to re-launch TRIESENCE for commercial use, we believe two additional, consecutive and successful PPQ batches (an aggregate of three
PPQ batches) of TRIESENCE will need to be made. A second PPQ batch was produced in July 2024, and we are currently waiting for analytical
results associated with this batch. If the second PPQ batch was produced successfully, the Company (along with its manufacturing partners)
expects to produce a third PPQ batch before the end of the third quarter 2024. If these three PPQ batches are manufactured successfully,
we believe TRIESENCE could be re-launched in the U.S. prior to the end of 2024. In accordance with the terms of the Asset Purchase Agreement
we entered into with Novartis Technology, LLC and Novartis Innovative Therapies AG (collectively, “Novartis”), a $37,000,000
milestone payment will be due to Novartis upon re-launch in the U.S.
Apotex
- Canadian Out-License
In
February 2024, we entered into a license and supply agreement with Apotex Inc. (“Apotex”). Under the terms of the agreement,
Apotex licensed exclusive rights and marketing authorizations of the following products in the Canadian market from Harrow: VERKAZIA
(cyclosporine ophthalmic emulsion) 0.1% and Cationorm PLUS. Apotex was also granted a license for products Apotex will pursue approval
for in Canada: VEVYE (cyclosporine ophthalmic solution) 0.1%, IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3%, and ZERVIATE (cetirizine
ophthalmic solution) 0.24% (with VERKAZIA and Cationorm Plus, collectively, the “Apotex Products”). In exchange for these
licenses, Apotex will make payments to Harrow for milestones related to manufacturing arrangements, regulatory and commercial achievements,
in addition to royalties on net sales of the Apotex Products.
IHEEZO
Reimbursement
In
January 2024, we met with the Centers for Medicare & Medicaid Services (“CMS”) to request clarification related to its
anesthesia billing policy which has historically not allowed for the separate billing of anesthesia services in the physician’s
office. During the meeting we requested that CMS clarify that J-Code 2403, IHEEZO’s permanent J-Code, is appropriate to be billed
for the anesthesia product itself (i.e., IHEEZO in our case) in the physician office setting. In March 2024, we received communication
from a representative at CMS that the inclusion of J-Code 2403 in CMS’s April 2024 quarterly drug pricing file of the average sales
prices (ASP) of some Medicare Part B-covered drugs and biologicals confirms that IHEEZO is separately payable in the physician office
setting.
In
February 2024, we made a request to CMS to consider increasing the Medically Unlikely Edits (“MUE”) for IHEEZO’s J-Code
from 1 to 2. This request was made because the limitation of one MUE only allowed a single IHEEZO administration (equal to one single-use
vial) to be used and billed, while many ophthalmologists perform bilateral ocular procedures, which would require two vials of IHEEZO
to be used. On March 20, 2024, we received communication from the National Correct Coding Initiative (NCCI) program of CMS stating
that CMS decided to increase the MUE for IHEEZO’s J-Code (J2403) from 1 to 2. The MUE edit was made effective on July 1, 2024.
VEVYE
U.S. Launch
In
January 2024, we launched VEVYE (cyclosporine ophthalmic solution) 0.1%, the first and only water-free cyclosporine dissolved in a semifluorinated
alkane approved to treat both the signs and symptoms of dry eye disease in the U.S. We partnered with various entities including PhilRx,
Apollo Care and PARx Solutions to enhance our market and patient access program for VEVYE.
Results
of Operations
The
following period-to-period comparisons of our financial results for the three and six months ended June 30, 2024 and 2023 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 Months Ended | | |
| | |
For the Six Months Ended | | |
| |
| |
June 30, | | |
$ | | |
June 30, | | |
$ | |
| |
2024 | | |
2023 | | |
Variance | | |
2024 | | |
2023 | | |
Variance | |
Product sales, net | |
$ | 48,871,000 | | |
$ | 29,542,000 | | |
$ | 19,329,000 | | |
$ | 83,379,000 | | |
$ | 49,995,000 | | |
$ | 33,384,000 | |
Other revenues | |
| 68,000 | | |
| 3,928,000 | | |
| (3,860,000 | ) | |
| 147,000 | | |
| 9,578,000 | | |
| (9,431,000 | ) |
Total revenues | |
$ | 48,939,000 | | |
$ | 33,470,000 | | |
$ | 15,469,000 | | |
$ | 83,526,000 | | |
$ | 59,573,000 | | |
$ | 23,953,000 | |
The
increase in revenues between periods was related to an increase in sales volumes of our branded ophthalmology products. During the three
and six months ended June 30, 2023, the Company recorded $3,928,000 and $9,578,000, respectively, in revenues associated with the transfer
of sales and profits of recently acquired products where the product new drug applications (“NDAs”) had not yet transferred
to Harrow. During the three months and six months ended June 30, 2024, revenues from branded products totalled $27,292,000 and $41,229,000,
respectively, compared to $13,095,000 and $19,367,000 (which included revenues from the transfer of profits) during the same periods
in the prior year, respectively. Net sales of IHEEZO were $11,294,000 and $13,616,000 during the three months and six months ended June
30, 2024, respectively.
Cost
of Sales
Our
cost of sales includes direct and indirect costs to manufacture formulations and 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, amortization of acquired product NDAs, and other related expenses.
The
following presents our cost of sales:
| |
For the Three Months Ended | | |
| | |
For the Six Months Ended | | |
| |
| |
June 30, | | |
$ | | |
June 30, | | |
$ | |
| |
2024 | | |
2023 | | |
Variance | | |
2024 | | |
2023 | | |
Variance | |
Cost of sales | |
$ | 12,539,000 | | |
$ | 10,000,000 | | |
$ | 2,539,000 | | |
$ | 23,092,000 | | |
$ | 18,271,000 | | |
$ | 4,821,000 | |
The
increase in our cost of sales was largely attributable to 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, | | |
$ | |
| |
2024 | | |
2023 | | |
Variance | | |
2024 | | |
2023 | | |
Variance | |
Gross Profit | |
$ | 36,400,000 | | |
$ | 23,470,000 | | |
$ | 12,930,000 | | |
$ | 60,434,000 | | |
$ | 41,302,000 | | |
$ | 19,132,000 | |
Gross Margin | |
| 74.38 | % | |
| 70.12 | % | |
| 4.26 | % | |
| 72.35 | % | |
| 69.33 | % | |
| 3.02 | % |
The
increase in gross margin between the three and six months ended June 30, 2024 and 2023 was primarily attributable to an increase in sales
associated with our branded ophthalmology products, which generally have a higher gross margin profile than our compounded products.
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 FDA approved, proprietary compounded formulations and other non-proprietary pharmacy products
and formulations.
The
following presents our selling, general and administrative expenses:
| |
For the Three Months Ended | | |
| | |
For the Six Months Ended | | |
| |
| |
June 30, | | |
$ | | |
June 30, | | |
$ | |
| |
2024 | | |
2023 | | |
Variance | | |
2024 | | |
2023 | | |
Variance | |
Selling, general and administrative | |
$ | 31,817,000 | | |
$ | 19,957,000 | | |
$ | 11,860,000 | | |
$ | 60,630,000 | | |
$ | 35,845,000 | | |
$ | 24,785,000 | |
The
increase in selling, general and administrative expenses between periods was primarily attributable to an increase in expenses including
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
VEVYE in December 2023. Stock-based compensation expense increased by $1,266,000 during the six months ended June 30, 2024 compared to
the prior year period.
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,
and other costs related to the clinical development of our assets.
The
following presents our research and development expenses:
| |
For the Three Months Ended | | |
| | |
For the Six Months Ended | | |
| |
| |
June 30, | | |
$ | | |
June 30, | | |
$ | |
| |
2024 | | |
2023 | | |
Variance | | |
2024 | | |
2023 | | |
Variance | |
Research and development | |
$ | 3,053,000 | | |
$ | 1,161,000 | | |
$ | 1,892,000 | | |
$ | 5,202,000 | | |
$ | 1,895,000 | | |
$ | 3,307,000 | |
The
increase in R&D expenses between periods was primarily attributable to activity related to our expanded branded product portfolio,
technical transfer activities associated with the production of certain products related to our product acquisitions that occurred in
2023, product development efforts, product launches, and clinical and medical support.
Interest
Expense, Net
Interest
expense, net was $5,471,000 and $10,886,000 for the three and six months ended June 30, 2024, respectively, compared to $5,704,000 and
$10,451,000 for the same periods in 2023, respectively. The decrease during the three months ended June 30, 2024 compared to the same
period in 2023 was primarily the result of increased interest income earned. The increase during the six months ended June 30, 2024 compared
to the same period in 2023 was primarily the result of the increase in the outstanding principal amount of our debt obligations.
Investment
(Loss) Gain from Eton
During
the three and six months ended June 30, 2024, we recorded a loss of $(1,923,000) and $(3,171,000), respectively, related to the change
in fair market value of Eton’s common stock at the time of its sale, including trading expenses and commissions of approximately
$436,000, compared to a loss of $(714,000) and gain of $1,328,000, respectively, during the same periods in 2023.
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 early payoff of a loan.
Other
Income, Net
During
the three and six months ended June 30, 2024, we recorded other income of $46,000 and $72,000, respectively, related to a sublease of
lab and office space in Nashville. 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.
Tax
(Expense)/Benefit
During
the three and six months ended June 30, 2024, we recorded income tax expense of $(655,000) and tax benefit of $15,000 and $303,000, during
the same periods in 2023, respectively. The income tax expense in 2024 is primarily related to the timing differences related to the
tax deductibility for stock-based compensation, interest expense and loss on our investment in Eton. We expect the timing differences
will result in taxable income for the year ending December 31, 2024.
Liquidity
and Capital Resources
Liquidity
Our
cash on hand at June 30, 2024 was $70,968,000, compared to $74,085,000 at December 31, 2023.
As
of the date of this Quarterly Report, we believe that our cash and cash equivalents 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 Surface Ophthalmics, Inc. (“Surface”) and Melt Pharmaceuticals,
Inc. (“Melt”) and any of our consolidated subsidiaries. However, we may pursue acquisitions of revenue generating products
or drug candidates or other strategic transactions that involve large expenditures or we may experience growth more rapidly 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, | |
| |
2024 | | |
2023 | |
Net cash (used in) provided by: | |
| | | |
| | |
Operating activities | |
$ | (7,374,000 | ) | |
$ | (3,648,000 | ) |
Investing activities | |
| 4,993,000 | | |
| (132,219,000 | ) |
Financing activities | |
| (736,000 | ) | |
| 62,351,000 | |
Net change in cash and cash equivalents | |
| (3,117,000 | ) | |
| (73,516,000 | ) |
Cash and cash equivalents at beginning of the period | |
| 74,085,000 | | |
| 96,270,000 | |
Cash and cash equivalents at end of the period | |
$ | 70,968,000 | | |
$ | 22,754,000 | |
Operating
Activities
Net
cash used in operating activities during the six months ended June 30, 2024 was $(7,374,000) compared to $(3,648,000) during the
same period in the prior year. The increase in net cash used in operating activities between the periods was mainly attributed to increase in operating expenses associated with the commercial launch of VEVYE in January 2024, including increased headcount associated with the sales force, recent product acquisition integrations and increased costs of goods
sold.
Investing
Activities
Net
cash provided by (used in) investing activities during the six months ended June 30, 2024 was $4,993,000 compared to $(132,219,000) during
the same period in the prior year. Cash used in investing activities in 2023 was primarily related to the acquisition of five branded
products completed in January 2023. Cash provided by investing activities in 2024 was primarily related to the sale of our investment
position in Eton.
Financing
Activities
Net
cash (used in) provided by financing activities during the six months ended June 30, 2024 and 2023 was $(736,000) and $62,351,000, respectively.
Cash used in financing activities during the six months ended June 30, 2024 was primarily related to payment of payroll taxes upon vesting
of RSUs in exchange for shares withheld from employees. Cash provided by financing activities during the six months ended June 30, 2023
was primarily related to proceeds received from the sale of notes in our 2023 capital markets transactions and entering into loan arrangements,
offset by repayment of the B. Riley senior secured note and payment of payroll taxes upon vesting and exercise of equity instruments
in exchange for shares withheld from employees.
Sources
of Capital
Our
principal sources of cash have consisted of sales of our common stock, debt issuances, sales of our investments, and on an annual basis
(e.g. for the year ended December 31, 2023) cash generated from operating activities. We may also sell some or all of our ownership interests
in Surface, Melt or our other subsidiaries.
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 options 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.
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, 2024. 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, 2024, 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, 2024, that has materially affected, or is reasonably likely to materially affect, our internal control over financial
reporting.
PART
II
OTHER
INFORMATION
Item
1. Legal Proceedings
See
Note 14 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, 2023, 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 investment.
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
None.
Item
6. Exhibits
Exhibit
Number |
|
Description |
|
|
|
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, 2024, has been formatted in Inline
XBRL. |
* |
Filed
herewith. |
** |
Furnished
herewith. |
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,
Inc. |
|
|
|
Dated:
August 7, 2024 |
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) |
EXHIBIT
31.1
CERTIFICATION
OF THE PRINCIPAL EXECUTIVE OFFICER UNDER
SECTION
302 OF THE SARBANES-OXLEY ACT
I,
Mark L. Baum, certify that:
|
(1) |
I
have reviewed this quarterly report on Form 10-Q of Harrow, Inc.; |
|
(2) |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
(3) |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
(4) |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
d) |
Disclosed
in the report any change in this registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
(5) |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions): |
|
a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 7, 2024 |
/s/
Mark L. Baum |
|
Mark
L. Baum
Chief
Executive Officer
Principal
Executive Officer |
EXHIBIT
31.2
CERTIFICATION
OF THE PRINCIPAL FINANCIAL OFFICER UNDER
SECTION
302 OF THE SARBANES-OXLEY ACT
I,
Andrew R. Boll, certify that:
|
(1) |
I
have reviewed this quarterly report on Form 10-Q of Harrow, Inc.; |
|
(2) |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
(3) |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
(4) |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
d) |
Disclosed
in the report any change in this registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
(5) |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions): |
|
a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 7, 2024 |
/s/
Andrew R. Boll |
|
Andrew
R. Boll
Chief
Financial Officer
(Principal
Financial and Accounting Officer) |
Exhibit
32.1
CERTIFICATION
REQUIRED BY
SECTION 1350 OF TITLE 18 OF THE UNITED STATES CODE
Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, each of the undersigned hereby certifies in his capacity as the specified officer of
Harrow, Inc. (the “Company”), that, to the best of his knowledge, the Quarterly Report of the Company on Form 10-Q for the
fiscal quarter ended June 30, 2024 fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange
Act of 1934, and that the information contained in such report fairly presents, in all material respects, the financial condition and
results of operations of the Company as of the dates and for the periods presented in the financial statements included in such report.
Date:
August 7, 2024 |
|
|
|
/s/
Mark L. Baum |
|
Mark
L. Baum
Chief Executive Officer
(Principal
Executive Officer) |
|
Date:
August 7, 2024 |
|
|
|
/s/
Andrew R. Boll |
|
Andrew
R. Boll
Chief Financial Officer
(Principal
Financial and Accounting Officer) |
|
This
certification accompanies this Report on Form 10-Q pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed
filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or
the Exchange Act, except to the extent that the Company specifically incorporates it by reference.
v3.24.2.u1
Cover - $ / shares
|
6 Months Ended |
|
Jun. 30, 2024 |
Aug. 07, 2024 |
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2024
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-35814
|
|
Entity Registrant Name |
Harrow,
Inc.
|
|
Entity Central Index Key |
0001360214
|
|
Entity Tax Identification Number |
45-0567010
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
102
Woodmont Blvd.
|
|
Entity Address, Address Line Two |
Suite 610
|
|
Entity Address, City or Town |
Nashville
|
|
Entity Address, State or Province |
TN
|
|
Entity Address, Postal Zip Code |
37205
|
|
City Area Code |
(615)
|
|
Local Phone Number |
733-4730
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
|
35,482,944
|
Entity Listing, Par Value Per Share |
$ 0.001
|
|
Common Stock, $0.001 par value per share [Member] |
|
|
Title of 12(b) Security |
Common
Stock, $0.001 par value per share
|
|
Trading Symbol |
HROW
|
|
Security Exchange Name |
NASDAQ
|
|
8.625% Senior Notes due 2026 [Member] |
|
|
Title of 12(b) Security |
8.625%
Senior Notes due 2026
|
|
Trading Symbol |
HROWL
|
|
Security Exchange Name |
NASDAQ
|
|
11.875% Senior Notes due 2027 [Member] |
|
|
Title of 12(b) Security |
11.875%
Senior Notes due 2027
|
|
Trading Symbol |
HROWM
|
|
Security Exchange Name |
NASDAQ
|
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v3.24.2.u1
Condensed Consolidated Balance Sheets - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets |
|
|
Cash and cash equivalents |
$ 70,968,000
|
$ 74,085,000
|
Investment in Eton Pharmaceuticals |
|
8,681,000
|
Accounts receivable, net |
51,988,000
|
36,261,000
|
Inventories |
9,425,000
|
10,867,000
|
Prepaid expenses and other current assets |
7,009,000
|
9,588,000
|
Total current assets |
139,390,000
|
139,482,000
|
Property, plant and equipment, net |
3,288,000
|
3,521,000
|
Capitalized software costs, net |
1,966,000
|
2,138,000
|
Operating lease right-of-use assets, net |
6,770,000
|
6,785,000
|
Intangible assets, net |
154,884,000
|
159,906,000
|
Goodwill |
332,000
|
332,000
|
TOTAL ASSETS |
306,630,000
|
312,164,000
|
Current liabilities |
|
|
Accounts payable and accrued expenses |
22,264,000
|
24,581,000
|
Accrued rebates and copay assistance |
24,551,000
|
18,432,000
|
Accrued payroll and related liabilities |
5,721,000
|
5,450,000
|
Deferred revenue and customer deposits |
248,000
|
75,000
|
Current portion of operating lease obligations |
767,000
|
806,000
|
Total current liabilities |
53,551,000
|
49,344,000
|
Operating lease obligations, net of current portion |
6,543,000
|
6,524,000
|
Accrued expenses, net of current portion |
2,713,000
|
2,713,000
|
Deferred tax liability |
623,000
|
|
Notes payable, net of unamortized debt discount |
185,023,000
|
183,172,000
|
TOTAL LIABILITIES |
248,453,000
|
241,753,000
|
Commitments and contingencies |
|
|
STOCKHOLDERS’ EQUITY |
|
|
Common stock, $0.001 par value, 50,000,000 shares authorized, 35,479,492 and 35,168,260 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively |
35,000
|
35,000
|
Additional paid-in capital |
212,439,000
|
204,635,000
|
Accumulated deficit |
(153,942,000)
|
(133,904,000)
|
TOTAL HARROW, INC. STOCKHOLDERS’ EQUITY |
58,532,000
|
70,766,000
|
Noncontrolling interests |
(355,000)
|
(355,000)
|
TOTAL STOCKHOLDERS’ EQUITY |
58,177,000
|
70,411,000
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ 306,630,000
|
$ 312,164,000
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
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$ 0.001
|
$ 0.001
|
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50,000,000
|
50,000,000
|
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v3.24.2.u1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Revenues: |
|
|
|
|
Total revenues |
$ 48,939,000
|
$ 33,470,000
|
$ 83,526,000
|
$ 59,573,000
|
Cost of sales |
(12,539,000)
|
(10,000,000)
|
(23,092,000)
|
(18,271,000)
|
Gross profit |
36,400,000
|
23,470,000
|
60,434,000
|
41,302,000
|
Operating expenses: |
|
|
|
|
Selling, general and administrative |
31,817,000
|
19,957,000
|
60,630,000
|
35,845,000
|
Research and development |
3,053,000
|
1,161,000
|
5,202,000
|
1,895,000
|
Total operating expenses |
34,870,000
|
21,118,000
|
65,832,000
|
37,740,000
|
Income (loss) from operations |
1,530,000
|
2,352,000
|
(5,398,000)
|
3,562,000
|
Other (expense) income: |
|
|
|
|
Interest expense, net |
(5,471,000)
|
(5,704,000)
|
(10,886,000)
|
(10,451,000)
|
Investment (loss) gain from Eton Pharmaceuticals |
(1,923,000)
|
(714,000)
|
(3,171,000)
|
1,328,000
|
Loss on extinguishment of debt |
|
|
|
(5,465,000)
|
Other income (expenses), net |
46,000
|
(178,000)
|
72,000
|
(149,000)
|
Total other expense, net |
(7,348,000)
|
(6,596,000)
|
(13,985,000)
|
(14,737,000)
|
Loss before income taxes |
(5,818,000)
|
(4,244,000)
|
(19,383,000)
|
(11,175,000)
|
Income tax (expense) benefit |
(655,000)
|
15,000
|
(655,000)
|
303,000
|
Net loss |
$ (6,473,000)
|
$ (4,229,000)
|
$ (20,038,000)
|
$ (10,872,000)
|
Basic net loss per share of common stock |
$ (0.18)
|
$ (0.14)
|
$ (0.56)
|
$ (0.36)
|
Diluted net loss per share of common stock |
$ (0.18)
|
$ (0.14)
|
$ (0.56)
|
$ (0.36)
|
Weighted average number of shares of common stock outstanding, basic |
35,618,977
|
30,458,677
|
35,544,312
|
30,379,354
|
Weighted average number of shares of common stock outstanding, diluted |
35,618,977
|
30,458,677
|
35,544,312
|
30,379,354
|
Product Sales, Net [Member] |
|
|
|
|
Revenues: |
|
|
|
|
Total revenues |
$ 48,871,000
|
$ 29,542,000
|
$ 83,379,000
|
$ 49,995,000
|
Other Revenues [Member] |
|
|
|
|
Revenues: |
|
|
|
|
Total revenues |
$ 68,000
|
$ 3,928,000
|
$ 147,000
|
$ 9,578,000
|
X |
- DefinitionThe aggregate costs related to goods produced and sold and services rendered by an entity during the reporting period. This excludes costs incurred during the reporting period related to financial services rendered and other revenue generating activities.
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v3.24.2.u1
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Parent [Member] |
Noncontrolling Interest [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 30,000
|
$ 137,058,000
|
$ (109,493,000)
|
$ 27,595,000
|
$ (355,000)
|
$ 27,240,000
|
Balance, shares at Dec. 31, 2022 |
29,901,530
|
|
|
|
|
|
Exercise of consultant stock-based options |
|
85,000
|
|
85,000
|
|
85,000
|
Exercise of consultant stock-based options, shares |
10,000
|
|
|
|
|
|
Exercise of employee stock-based options |
|
252,000
|
|
252,000
|
|
252,000
|
Exercise of employee stock-based options, shares |
216,816
|
|
|
|
|
|
Vesting of RSUs |
|
|
|
|
|
|
Vesting of RSUs, shares |
242,760
|
|
|
|
|
|
Shares withheld related to net share settlement of equity awards |
|
(1,698,000)
|
|
(1,698,000)
|
|
(1,698,000)
|
Shares withheld related to net share settlement of equity awards, shares |
(94,168)
|
|
|
|
|
|
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 Jun. 30, 2023 |
$ 30,000
|
142,742,000
|
(120,365,000)
|
22,407,000
|
(355,000)
|
22,052,000
|
Balance, shares at Jun. 30, 2023 |
30,276,938
|
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 30,000
|
137,989,000
|
(116,136,000)
|
21,883,000
|
(355,000)
|
21,528,000
|
Balance, shares at Mar. 31, 2023 |
30,056,370
|
|
|
|
|
|
Exercise of consultant stock-based options |
|
85,000
|
|
85,000
|
|
85,000
|
Exercise of consultant stock-based options, shares |
10,000
|
|
|
|
|
|
Exercise of employee stock-based options |
|
104,000
|
|
104,000
|
|
104,000
|
Exercise of employee stock-based options, shares |
119,274
|
|
|
|
|
|
Vesting of RSUs |
|
|
|
|
|
|
Vesting of RSUs, shares |
131,760
|
|
|
|
|
|
Shares withheld related to net share settlement of equity awards |
|
(848,000)
|
|
(848,000)
|
|
(848,000)
|
Shares withheld related to net share settlement of equity awards, shares |
(40,466)
|
|
|
|
|
|
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 Jun. 30, 2023 |
$ 30,000
|
142,742,000
|
(120,365,000)
|
22,407,000
|
(355,000)
|
22,052,000
|
Balance, shares at Jun. 30, 2023 |
30,276,938
|
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 35,000
|
204,635,000
|
(133,904,000)
|
70,766,000
|
(355,000)
|
70,411,000
|
Balance, shares at Dec. 31, 2023 |
35,168,260
|
|
|
|
|
|
Exercise of consultant stock-based options, shares |
700
|
|
|
|
|
|
Exercise of employee stock-based options |
|
521,000
|
|
521,000
|
|
521,000
|
Exercise of employee stock-based options, shares |
87,195
|
|
|
|
|
|
Vesting of RSUs |
|
|
|
|
|
|
Vesting of RSUs, shares |
332,517
|
|
|
|
|
|
Shares withheld related to net share settlement of equity awards |
|
(1,157,000)
|
|
(1,157,000)
|
|
(1,157,000)
|
Shares withheld related to net share settlement of equity awards, shares |
(108,480)
|
|
|
|
|
|
Stock-based compensation expense |
|
8,440,000
|
|
8,440,000
|
|
8,440,000
|
Net loss |
|
|
(20,038,000)
|
(20,038,000)
|
|
(20,038,000)
|
Balance at Jun. 30, 2024 |
$ 35,000
|
212,439,000
|
(153,942,000)
|
58,532,000
|
(355,000)
|
58,177,000
|
Balance, shares at Jun. 30, 2024 |
35,479,492
|
|
|
|
|
|
Balance at Mar. 31, 2024 |
$ 35,000
|
207,995,000
|
(147,469,000)
|
60,561,000
|
(355,000)
|
60,206,000
|
Balance, shares at Mar. 31, 2024 |
35,380,955
|
|
|
|
|
|
Exercise of employee stock-based options |
|
173,000
|
|
173,000
|
|
173,000
|
Exercise of employee stock-based options, shares |
41,020
|
|
|
|
|
|
Vesting of RSUs |
|
|
|
|
|
|
Vesting of RSUs, shares |
57,517
|
|
|
|
|
|
Stock-based compensation expense |
|
4,271,000
|
|
4,271,000
|
|
4,271,000
|
Net loss |
|
|
(6,473,000)
|
(6,473,000)
|
|
(6,473,000)
|
Balance at Jun. 30, 2024 |
$ 35,000
|
$ 212,439,000
|
$ (153,942,000)
|
$ 58,532,000
|
$ (355,000)
|
$ 58,177,000
|
Balance, shares at Jun. 30, 2024 |
35,479,492
|
|
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
Net loss |
$ (20,038,000)
|
$ (10,872,000)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization of property, plant and equipment and software development costs |
885,000
|
690,000
|
Amortization of intangible assets |
5,103,000
|
5,050,000
|
Amortization of operating lease right-of-use assets |
392,000
|
357,000
|
(Recovery of) provision for credit losses |
(96,000)
|
29,000
|
Amortization of debt issuance costs and debt discount |
1,951,000
|
1,623,000
|
Investment loss (gain) from investment in Eton |
3,171,000
|
(1,328,000)
|
Loss on extinguishment of debt |
|
5,465,000
|
Stock-based compensation |
8,440,000
|
7,045,000
|
Deferred income tax |
623,000
|
(288,000)
|
Changes in assets and liabilities: |
|
|
Accounts receivable |
(15,631,000)
|
(12,038,000)
|
Inventories |
1,442,000
|
(2,014,000)
|
Prepaid expenses and other current assets |
2,579,000
|
(201,000)
|
Accounts payable, accrued expenses, accrued rebates and copay assistance |
3,361,000
|
3,584,000
|
Accrued payroll and related liabilities |
271,000
|
(769,000)
|
Deferred revenue and customer deposits |
173,000
|
19,000
|
NET CASH USED IN OPERATING ACTIVITIES |
(7,374,000)
|
(3,648,000)
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
Net proceeds on sale of Eton Pharmaceuticals |
5,510,000
|
|
Investment in patent and trademark assets |
(81,000)
|
|
Purchase of product NDAs and related patents |
|
(131,473,000)
|
Purchases of property, plant and equipment |
(436,000)
|
(746,000)
|
NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES |
4,993,000
|
(132,219,000)
|
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 debt issuance costs |
(100,000)
|
|
Payment of payroll taxes upon vesting of PSUs, RSUs and exercise of stock options |
(1,157,000)
|
(661,000)
|
Proceeds from exercise of stock options |
521,000
|
337,000
|
Proceeds from B. Riley senior secured note, net of costs |
|
55,879,000
|
Repayment of B. Riley senior secured note |
|
(59,750,000)
|
NET CASH (USED IN) PROVIDED BY FINANCING ACTIVITIES |
(736,000)
|
62,351,000
|
NET CHANGE IN CASH AND CASH EQUIVALENTS |
(3,117,000)
|
(73,516,000)
|
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD |
74,085,000
|
96,270,000
|
CASH AND CASH EQUIVALENTS AT END OF PERIOD |
70,968,000
|
22,754,000
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: |
|
|
Cash paid for income taxes |
|
4,000
|
Cash paid for interest |
10,316,000
|
8,076,000
|
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 |
|
2,275,000
|
Purchase of property, plant and equipment included in accounts payable and accrued expenses |
44,000
|
115,000
|
Right-of-use assets obtained in exchange for new operating lease obligations |
377,000
|
|
Income taxes owed for exercise of options |
|
$ 1,037,000
|
X |
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v3.24.2.u1
Pay vs Performance Disclosure - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Pay vs Performance Disclosure [Table] |
|
|
|
|
Net Income (Loss) |
$ (6,473,000)
|
$ (4,229,000)
|
$ (20,038,000)
|
$ (10,872,000)
|
X |
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v3.24.2.u1
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION |
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 six months ended June
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.
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- DefinitionThe entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
NOTE
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The
following represents an update for the three and six months ended June 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.
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.
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, 2024 was $52,727,000, net of $235,000
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, 2024:
SCHEDULE
OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS
Balance at January 1, 2024 | |
$ | 371,000 | |
Change in expected credit losses | |
| (96,000 | ) |
Write-offs, net of recoveries | |
| (40,000 | ) |
Balance at June 30, 2024 | |
$ | 235,000 | |
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 1,982,000 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.
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
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
Carrying Value | | |
Fair Value | | |
Carrying Value | | |
Fair Value | |
2026 Notes | |
$ | 73,607,000 | | |
$ | 76,470,000 | | |
$ | 73,218,000 | | |
$ | 70,260,000 | |
2027 Notes | |
$ | 37,770,000 | | |
$ | 43,019,000 | | |
$ | 37,413,000 | | |
$ | 40,363,000 | |
Oaktree Loan | |
$ | 73,646,000 | | |
$ | 77,500,000 | | |
$ | 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, 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 4,488,940 and 6,131,026
at June 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 June 30, 2024 and 2023 was 181,038 and 234,027, 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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended June 30, | | |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Numerator – net loss | |
$ | (6,473,000 | ) | |
$ | (4,229,000 | ) | |
$ | (20,038,000 | ) | |
$ | (10,872,000 | ) |
Denominator – weighted average number of shares outstanding, basic and diluted | |
| 35,618,977 | | |
| 30,458,677 | | |
| 35,544,312 | | |
| 30,379,354 | |
Net loss per share, basic and diluted | |
$ | (0.18 | ) | |
$ | (0.14 | ) | |
$ | (0.56 | ) | |
$ | (0.36 | ) |
Income
Taxes
The
Company’s effective tax rate was 3.38% and (2.71)% for the six months ended June 30, 2024 and 2023, respectively. The Company’s
effective tax rate for the six months ended June 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 (“IRC”), Section 162(m) excess
officer compensation limitation and share-based compensation and the change in valuation allowance.
As
of June 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 June 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 June 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 June 30, 2024
In
August 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-05,
Business Combinations—Joint Venture Formations (Subtopic 805-60): Recognition and Initial Measurement, which applies to
the formation of entities that meet the definition of a joint venture (or a corporate joint venture) and requires joint ventures to initially
measure all contributions received upon formation at fair value. The new guidance does not impact accounting by the venturers. The new
guidance is applicable to joint venture entities with a formation date on or after January 1, 2025 on a prospective basis. Joint ventures
formed prior to the effective date may elect to apply the new guidance retrospectively back to their original formation date. The Company
will apply the guidance in ASU 2023-05 prospectively to any future arrangements meeting the definition of a joint venture.
In
October 2023, FASB issued 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
in 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.
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.24.2.u1
REVENUES
|
6 Months Ended |
Jun. 30, 2024 |
Revenue from Contract with Customer [Abstract] |
|
REVENUES |
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 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, 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.
Intellectual
Property License and Related Arrangements Revenues
As
of June 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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended | | |
For the Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Product sales, net | |
$ | 48,871,000 | | |
$ | 29,542,000 | | |
$ | 83,379,000 | | |
$ | 49,995,000 | |
Other revenues | |
| 68,000 | | |
| 3,928,000 | | |
| 147,000 | | |
| 9,578,000 | |
Total revenues | |
$ | 48,939,000 | | |
$ | 33,470,000 | | |
$ | 83,526,000 | | |
$ | 59,573,000 | |
Deferred
revenue and customer deposits at June 30, 2024 and December 31, 2023 were $248,000 and $75,000, respectively. All deferred revenue and
customer deposit amounts at December 31, 2023 were recognized as revenue during the six months ended June 30, 2024.
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v3.24.2.u1
INVESTMENT IN, AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC. - RELATED PARTY TRANSACTIONS
|
6 Months Ended |
Jun. 30, 2024 |
Investments, Debt and Equity Securities [Abstract] |
|
INVESTMENT IN, AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC. - RELATED PARTY TRANSACTIONS |
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 six months ended June 30, 2024, the Company did not record
any reimbursable expenses and amounts payable by Melt pursuant to the Melts MSA. During the three and six months ended June 30,
2023, the Company recorded $30,000
and $40,000
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 each of June 30, 2024 and
December 31, 2023, the Company was due $228,000
from Melt for reimbursable expenses and amounts payable under the Melt MSA.
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
| |
2024 | | |
2023 | |
| |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Revenues, net | |
$ | - | | |
$ | - | |
Loss from operations | |
$ | (5,631,000 | ) | |
$ | (2,448,000 | ) |
Net loss | |
$ | (5,344,000 | ) | |
$ | (3,551,000 | ) |
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE
OF CONDENSED BALANCE SHEET
| |
2024 | | |
2023 | |
| |
At June 30, | | |
At December 31, | |
| |
2024 | | |
2023 | |
Current assets | |
$ | 11,284,000 | | |
$ | 13,404,000 | |
Non-current assets | |
| - | | |
| - | |
Total assets | |
$ | 11,284,000 | | |
$ | 13,404,000 | |
| |
| | | |
| | |
Total liabilities | |
$ | 3,794,000 | | |
$ | 3,922,000 | |
Total stockholders’ equity | |
| 7,490,000 | | |
| 9,482,000 | |
Total liabilities and stockholders’ equity | |
$ | 11,284,000 | | |
$ | 13,404,000 | |
|
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v3.24.2.u1
INVENTORIES
|
6 Months Ended |
Jun. 30, 2024 |
Inventory Disclosure [Abstract] |
|
INVENTORIES |
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 June 30,
2024 | | |
At December 31,
2023 | |
Raw materials | |
$ | 4,964,000 | | |
$ | 5,477,000 | |
Work in progress | |
| 137,000 | | |
| 54,000 | |
Finished goods | |
| 4,324,000 | | |
| 5,336,000 | |
Total inventories | |
$ | 9,425,000 | | |
$ | 10,867,000 | |
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v3.24.2.u1
PREPAID EXPENSES AND OTHER CURRENT ASSETS
|
6 Months Ended |
Jun. 30, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
PREPAID EXPENSES AND OTHER CURRENT ASSETS |
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 June 30,
2024 | | |
At December 31,
2023 | |
Prepaid insurance | |
$ | 306,000 | | |
$ | 1,241,000 | |
Prepaid computer software licenses and related expenses | |
| 952,000 | | |
| 963,000 | |
Other prepaid expenses | |
| 2,470,000 | | |
| 1,556,000 | |
Receivable due from Melt | |
| 228,000 | | |
| 228,000 | |
Prepaid FY 2024 Prescription Drug User (“PDUFA”) fees | |
| 1,146,000 | | |
| 3,438,000 | |
Deferred Oaktree Loan commitment fee | |
| 454,000 | | |
| 409,000 | |
Deposits and other current assets | |
| 1,453,000 | | |
| 1,753,000 | |
Total prepaid expenses and other current assets | |
$ | 7,009,000 | | |
$ | 9,588,000 | |
|
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v3.24.2.u1
PROPERTY, PLANT AND EQUIPMENT
|
6 Months Ended |
Jun. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
PROPERTY, PLANT AND EQUIPMENT |
NOTE
7. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment consisted of the following:
SCHEDULE
OF PROPERTY, PLANT AND EQUIPMENT
| |
At June 30,
2024 | | |
At December 31,
2023 | |
Property, plant and equipment, net: | |
| | | |
| | |
Computer hardware | |
$ | 1,434,000 | | |
$ | 1,322,000 | |
Furniture and equipment | |
| 942,000 | | |
| 936,000 | |
Lab and pharmacy equipment | |
| 4,737,000 | | |
| 4,564,000 | |
Leasehold improvements | |
| 6,844,000 | | |
| 6,771,000 | |
Property, plant and equipment, gross | |
| 13,957,000 | | |
| 13,593,000 | |
Accumulated depreciation | |
| (10,669,000 | ) | |
| (10,072,000 | ) |
Property, plant and equipment,
net | |
$ | 3,288,000 | | |
$ | 3,521,000 | |
For
the three and six months ended June 30, 2024, depreciation related to property, plant and equipment was $301,000 and $597,000, respectively,
compared to $228,000 and $453,000 during the same periods in 2023, respectively.
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v3.24.2.u1
CAPITALIZED SOFTWARE COSTS
|
6 Months Ended |
Jun. 30, 2024 |
Capitalized Software Costs |
|
CAPITALIZED SOFTWARE COSTS |
NOTE
8. CAPITALIZED SOFTWARE COSTS
Capitalized
software costs consisted of the following:
SCHEDULE OF CAPITALIZED SOFTWARE COSTS
| |
At June 30,
2024 | | |
At December 31,
2023 | |
Capitalized software costs | |
| | | |
| | |
Capitalized internal-use software development costs | |
$ | 3,318,000 | | |
$ | 2,780,000 | |
Acquired third-party software license for internal-use | |
| 204,000 | | |
| 159,000 | |
Total gross capitalized software for internal-use | |
| 3,522,000 | | |
| 2,939,000 | |
Accumulated amortization | |
| (1,556,000 | ) | |
| (1,268,000 | ) |
Capitalized internal-use software in process | |
| - | | |
| 467,000 | |
Total capitalized software
costs net | |
$ | 1,966,000 | | |
$ | 2,138,000 | |
The
Company recorded amortization expense of $152,000 and $288,000 related to capitalized software costs during the three and six months
ended June 30, 2024, respectively, and $170,000 and $237,000 during the same periods in 2023, respectively.
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v3.24.2.u1
INTANGIBLE ASSETS AND GOODWILL
|
6 Months Ended |
Jun. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
INTANGIBLE ASSETS AND GOODWILL |
NOTE
9. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at June 30, 2024 consisted of the following:
SCHEDULE OF INTANGIBLE ASSETS
| |
Amortization Periods (in years) | |
Cost | | |
Accumulated Amortization | | |
Disposal | | |
Net Carrying Value | |
Patents | |
7-19 | |
$ | 610,000 | | |
$ | (188,000 | ) | |
$ | - | | |
$ | 422,000 | |
Licenses | |
7-20 | |
| 50,000 | | |
| (2,000 | ) | |
| - | | |
| 48,000 | |
Trademarks | |
Indefinite | |
| 234,000 | | |
| - | | |
| - | | |
| 234,000 | |
Acquired NDAs | |
4-15 | |
| 170,398,000 | | |
| (16,352,000 | ) | |
| - | | |
| 154,046,000 | |
Customer relationships | |
3-15 | |
| 596,000 | | |
| (536,000 | ) | |
| - | | |
| 60,000 | |
Trade name | |
5 | |
| 75,000 | | |
| (6,000 | ) | |
| - | | |
| 69,000 | |
Non-competition clause | |
3-4 | |
| 50,000 | | |
| (50,000 | ) | |
| - | | |
| - | |
State pharmacy licenses | |
25 | |
| 8,000 | | |
| (3,000 | ) | |
| - | | |
| 5,000 | |
| |
| |
$ | 172,021,000 | | |
$ | (17,137,000 | ) | |
$ | - | | |
$ | 154,884,000 | |
Amortization
expense for intangible assets was as follows:
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended | | |
For the Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Patents | |
$ | 14,000 | | |
$ | 21,000 | | |
$ | 28,000 | | |
$ | 43,000 | |
Licenses | |
| - | | |
| 3,000 | | |
| - | | |
| 5,000 | |
Acquired NDAs | |
| 2,529,000 | | |
| 2,805,000 | | |
| 5,059,000 | | |
| 4,975,000 | |
Customer relationships | |
| 6,000 | | |
| 14,000 | | |
| 16,000 | | |
| 27,000 | |
Amortization
expense of intangible assets | |
$ | 2,549,000 | | |
$ | 2,843,000 | | |
$ | 5,103,000 | | |
$ | 5,050,000 | |
Estimated
future amortization expenses for the Company’s intangible assets at June 30, 2024 was as follows:
SCHEDULE
OF ESTIMATED FUTURE AMORTIZATION EXPENSE
| |
| | |
Remainder of 2024 | |
$ | 5,098,000 | |
2025 | |
| 13,658,000 | |
2026 | |
| 13,658,000 | |
2027 | |
| 13,309,000 | |
2028 | |
| 12,961,000 | |
Thereafter | |
| 95,966,000 | |
Intangible
assets | |
$ | 154,650,000 | |
There
were no changes to the carrying value of the Company’s goodwill during the three and six months ended June 30, 2024 and 2023.
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v3.24.2.u1
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
ACCOUNTS PAYABLE AND ACCRUED EXPENSES |
NOTE
10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses consisted of the following:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
| |
At June 30, | | |
At December 31, | |
| |
2024 | | |
2023 | |
Accounts payable | |
$ | 20,177,000 | | |
$ | 21,424,000 | |
Accrued insurance premium | |
| - | | |
| 873,000 | |
Other accrued payments | |
| 106,000 | | |
| 306,000 | |
Accrued interest (see Note 11) | |
| 1,981,000 | | |
| 1,978,000 | |
Accrued exit fee for Oaktree Loan (see Note 11) | |
| 2,713,000 | | |
| 2,713,000 | |
Total accounts payable and accrued expenses | |
$ | 24,977,000 | | |
$ | 27,294,000 | |
Less: current portion | |
| (22,264,000 | ) | |
| (24,581,000 | ) |
Non-current total accrued expenses | |
$ | 2,713,000 | | |
$ | 2,713,000 | |
The
Company financed insurance policies for the policy terms of August 2023 through August 2024. The financing agreement had an interest
rate of 7.48% per annum and required nine monthly payments of $150,000 all of which had been paid as of June 30, 2024.
|
X |
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v3.24.2.u1
DEBT
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
DEBT |
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 (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. 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 “Oaktree Amendment”). Under the Oaktree 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”) is 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 $2,944,000 and $5,897,000 for the three and six months ended June 30, 2024, respectively,
and included the amortization of debt issuance costs and discount of $602,000 and $1,205,000, respectively. 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.
The
Oaktree Loan carries an exit fee equal to 3.5% of the aggregate principal amount owed, payable at maturity. As of June 30, 2024 and December
31, 2023, the Company had recorded in accrued expenses the total exit fee liability of $2,713,000.
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 $1,373,000 and $2,746,000 for the three and six
months ended June 30, 2024, respectively, and included amortization of debt issuance costs and debt discount of $178,000 and $356,000,
respectively. 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.
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”). Interest expense related to the 2026 Notes totaled $1,812,000
and $3,624,000 for the three and six months ended June 30, 2024, respectively, and included amortization of debt issuance costs and debt
discount of $195,000 and $390,000, respectively. Interest expense related to the 2026 Notes totaled $1,812,000 and $3,622,000 for the
three and six months ended June 30, 2023, respectively, and included amortization of debt issuance costs and debt discount of $195,000
and $388,000, respectively.
A
summary of the Company’s debt is described as follows:
SCHEDULE OF LONG TERM DEBT
| |
At June 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 | |
| (7,727,000 | ) | |
| (9,578,000 | ) |
Notes payable net | |
$ | 185,023,000 | | |
$ | 183,172,000 | |
For
the three and six months ended June 30, 2024, the total effective interest rate of the Company’s debt was 10.78% and 10.88%, respectively,
and 10.71% and 10.81% for the same periods in 2023, respectively.
At
June 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 | |
$ | 10,674,000 | |
2025 | |
| 20,658,000 | |
2026 | |
| 159,899,000 | |
2027 | |
| 45,030,000 | |
Total minimum payments | |
| 236,261,000 | |
Less: amount representing interest payments | |
| (43,511,000 | ) |
Notes payable, gross principal amount due | |
| 192,750,000 | |
Less: unamortized debt issuance costs, net of premium | |
| (7,727,000 | ) |
Notes payable, net of unamortized debt issuance costs | |
$ | 185,023,000 | |
|
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.24.2.u1
LEASES
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
LEASES |
NOTE
12. LEASES
The
Company leases office and laboratory space under non-cancelable 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 which is expected to
commence in August 2024 and has a term (target expiration date of June 30, 2032) with an option to extend the term for
two additional five-year periods. Once occupied, the Company expects this office space to serve as the Company’s new corporate
headquarters. Any operating lease right-of-use assets and liabilities related to this lease will be recognized at its commencement
date. |
At
June 30, 2024, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases
held by the Company were 6.60% and 11.2 years, respectively.
During
the three and six months ended June 30, 2024, cash paid for amounts included for the operating lease liabilities was $327,000 and $650,000,
respectively, and $306,000 and $611,000 for the same periods in 2023, respectively. During the three and six months ended June 30, 2024,
the Company recorded operating lease expense of $319,000 and $638,000, respectively, and $308,000 and $617,000 for the same periods in
2023, respectively, which is included in selling, general and administrative expenses.
Future
lease payments under operating leases as of June 30, 2024 were as follows:
SCHEDULE
OF FUTURE LEASE PAYMENTS UNDER OPERATING LEASES
| |
Operating Leases | |
Remainder of 2024 | |
$ | 655,000 | |
2025 | |
| 1,133,000 | |
2026 | |
| 1,155,000 | |
2027 | |
| 1,014,000 | |
2028 | |
| 699,000 | |
Thereafter | |
| 5,533,000 | |
Total minimum lease payments | |
| 10,189,000 | |
Less: amount representing interest payments | |
| (2,879,000 | ) |
Total operating lease obligations | |
| 7,310,000 | |
Less: current portion, operating lease obligations | |
| (767,000 | ) |
Operating lease obligations, net of current portion | |
$ | 6,543,000 | |
|
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- DefinitionThe entire disclosure for operating leases of lessee. Includes, but is not limited to, description of operating lease and maturity analysis of operating lease liability.
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v3.24.2.u1
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION |
NOTE
13. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Common
Stock
During
the six months ended June 30, 2024, the Company issued 86,996 shares of common stock and received proceeds of $521,000 upon the exercise
of options to purchase 86,996 shares of common stock with exercise prices ranging from $1.70 to $12.38 per share.
During
the six months ended June 30, 2024, the Company issued 199 shares of common stock upon the cashless exercise of options to purchase 700
shares at an exercise price of $7.60 per share.
During
the six months ended June 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 six months ended June 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 six months ended June 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 six months ended June 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 six months ended June 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 six months ended June
30, 2024, but the issuance and delivery of the shares were deferred until the director ceased providing services to the Company.
During
the six months ended June 30, 2024, 23,016 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.
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, 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
173,219 shares available for future issuances under the 2017 Plan at June 30, 2024.
Stock
Options
A
summary of stock option activity under the Plans for the six months ended June 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 | |
| 105,500 | | |
$ | 10.13 | | |
| | | |
| | |
Options exercised | |
| (87,696 | ) | |
$ | 6.02 | | |
| | | |
| | |
Options cancelled/forfeited | |
| (79,938 | ) | |
$ | 13.95 | | |
| | | |
| | |
Options outstanding – June 30, 2024 | |
| 2,649,183 | | |
$ | 6.18 | | |
| 3.62 | | |
$ | 39,021,000 | |
Options exercisable | |
| 2,382,865 | | |
$ | 5.62 | | |
| 3.03 | | |
$ | 36,398,000 | |
Options vested and expected to vest | |
| 2,612,254 | | |
$ | 6.10 | | |
| 3.54 | | |
$ | 38,667,000 | |
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 28, 2024, based on the closing price of the Company’s common stock of $20.89 on that
date.
During
the six months ended June 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 six months ended June 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. 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
| |
2024 | |
Weighted-average fair value of options granted | |
$ | 6.57 | |
Expected terms (in years) | |
| 6.11 | |
Expected volatility | |
| 68 | % |
Risk-free interest rate | |
| 4.06-4.48 | % |
Dividend yield | |
| - | |
The
following table summarizes information about stock options outstanding and exercisable at June 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 - $1.73 | |
| 287,852 | | |
| 3.47 | | |
$ | 1.72 | | |
| 287,852 | | |
$ | 1.72 | |
$2.23 | |
| 270,000 | | |
| 2.59 | | |
$ | 2.23 | | |
| 270,000 | | |
$ | 2.23 | |
$2.40 - $2.60 | |
| 23,068 | | |
| 2.51 | | |
$ | 2.58 | | |
| 23,068 | | |
$ | 2.58 | |
$3.95 | |
| 308,500 | | |
| 1.75 | | |
$ | 3.95 | | |
| 308,500 | | |
$ | 3.95 | |
$4.49 - $5.72 | |
| 99,912 | | |
| 4.97 | | |
$ | 5.54 | | |
| 97,978 | | |
$ | 5.53 | |
$6.30 | |
| 285,000 | | |
| 4.64 | | |
$ | 6.30 | | |
| 285,000 | | |
$ | 6.30 | |
$6.75 - $7.26 | |
| 58,406 | | |
| 7.90 | | |
$ | 6.92 | | |
| 26,566 | | |
$ | 6.93 | |
$7.30 | |
| 274,500 | | |
| 5.51 | | |
$ | 7.30 | | |
| 274,500 | | |
$ | 7.30 | |
$7.37 - $7.79 | |
| 191,210 | | |
| 3.68 | | |
$ | 7.50 | | |
| 149,534 | | |
$ | 7.47 | |
$7.87 - $25.86 | |
| 850,735 | | |
| 3.27 | | |
$ | 9.17 | | |
| 659,867 | | |
$ | 8.14 | |
$1.47 - $25.86 | |
| 2,649,183 | | |
| 3.62 | | |
$ | 6.18 | | |
| 2,382,865 | | |
$ | 5.62 | |
As
of June 30, 2024, there was approximately $1,723,000 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 $130,000 and $256,000 during the three and six months ended June 30, 2024, respectively, and $122,000
and $463,000 during the same periods in 2023, respectively.
The
intrinsic value of options exercised during the six months ended June 30, 2024 was $694,000.
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 six months ended June 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 | |
| 213,081 | | |
| 17.22 | |
RSUs vested | |
| (298,016 | ) | |
| 9.51 | |
RSUs cancelled/forfeited | |
| (6,250 | ) | |
| 8.10 | |
RSUs unvested - June 30, 2024 | |
| 271,844 | | |
$ | 15.21 | |
As
of June 30, 2024, the total unrecognized compensation expense related to unvested RSUs was approximately $3,945,000, which is expected
to be recognized over a weighted-average period of 2.2 years, based on estimated and actual vesting schedules of the applicable RSUs.
The stock-based compensation for RSUs during the three and six months ended June 30, 2024 was $502,000 and $907,000, respectively, and
was $122,000 and $463,000 during the same periods in 2023, respectively.
Performance
Stock Units
A
summary of the Company’s PSU activity and related information for the six months ended June 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 – June 30, 2024 | |
| 1,567,913 | | |
$ | 18.56 | |
As
of June 30, 2024, the total unrecognized compensation expense related to unvested PSUs was approximately $14,553,000, which is expected
to be recognized over a weighted-average period of 0.76 years, based on estimated and actual vesting schedules of the applicable PSUs.
The stock-based compensation for PSUs during the three and six months ended June 30, 2024 was $3,638,000 and $7,276,000, respectively,
and $5,290,000 and $6,582,000 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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended June 30, | | |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Employees - selling, general and administrative | |
$ | 3,579,000 | | |
$ | 4,607,000 | | |
$ | 7,104,000 | | |
$ | 5,935,000 | |
Employees - research and development | |
| 439,000 | | |
| 586,000 | | |
| 878,000 | | |
| 749,000 | |
Directors - selling, general and administrative | |
| 214,000 | | |
| 203,000 | | |
| 402,000 | | |
| 328,000 | |
Consultants - selling, general and administrative | |
| 39,000 | | |
| 16,000 | | |
| 56,000 | | |
| 33,000 | |
Total | |
$ | 4,271,000 | | |
$ | 5,412,000 | | |
$ | 8,440,000 | | |
$ | 7,045,000 | |
|
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
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 matter was expected to go to trial in August 2024, however, due to scheduling
conflicts with the Court, the trial will be re-scheduled to a later date that has not yet been determined.
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 six months ended June 30, 2024, $1,036,000
and $1,310,000,
respectively, were incurred under these agreements as royalty expenses, and $0
and $0, respectively,
during the same periods in 2023. During the three and six months ended June 30, 2024, $0
were incurred under these agreements related to upfront and milestone payments under these agreements, respectively, and $0
and $5,000,000, respectively,
during the same periods in 2023. As of June 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 six months ended June 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 certain milestones, 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 six months ended June 30, 2024, $316,000 and $496,000, respectively, were incurred under these agreements as royalty
expenses and $275,000 and $651,000, respectively, during the same periods in 2023.
Sales
and Marketing Agreements
The
Company had 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 six months ended June 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.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.2.u1
SEGMENTS AND CONCENTRATIONS
|
6 Months Ended |
Jun. 30, 2024 |
Segment Reporting [Abstract] |
|
SEGMENTS AND CONCENTRATIONS |
NOTE
15. 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. An operating segment is defined as a component of an entity that engages in business activities from which it may
recognize revenues and incur expense, its operating results are regularly reviewed by the entity’s chief operating decision maker
(“CODM”) to make decisions about resources to be allocated to the segment and assess its performance, and its discrete financial
information is available. The Company’s CODM, who is the Chief Executive Officer, evaluates
the Company as a single operating segment, consistent with internal management reporting.
The
Company had one product that accounted for more than 10% of total revenues during the three and six months ended June 30, 2024. The Company had 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.
These products collectively accounted for 23% and 14% of revenues during the three and six months ended June 30, 2024, respectively.
For the same periods in the prior year these products collectively accounted for 48% and 38% of revenues during the three and six months
ended June 30, 2023.
As
of June 30, 2024 and December 31, 2023, accounts receivable from a single customer accounted for 67%
and 80%
of total accounts receivable, respectively. For the three and six months ended June 30, 2024, revenues from a single customer
accounted for 45%
and 40% of total revenues, 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.
The
Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 61%
and 62% of active pharmaceutical ingredient purchases during the three and six months ended June 30, 2024, respectively, and 80%
and 85%
during the same periods in 2023, respectively.
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- DefinitionThe entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.
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v3.24.2.u1
SUBSEQUENT EVENTS
|
6 Months Ended |
Jun. 30, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
16. SUBSEQUENT EVENTS
The
Company has performed an evaluation of events occurring subsequent to June 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
July 2024, the Company issued 2,563
shares of common stock and received proceeds of $53,000
upon the exercise of options to purchase 2,563
shares of common stock with exercise prices between $7.60 and $20.97
per share.
In July 2024, the Company issued 889 shares of common stock upon the cashless exercise of options to purchase 1,000
shares at an exercise price of $2.60 per share.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Risks, Uncertainties and Liquidity |
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 |
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 June 30, 2024 was $52,727,000, net of $235,000
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, 2024:
SCHEDULE
OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS
Balance at January 1, 2024 | |
$ | 371,000 | |
Change in expected credit losses | |
| (96,000 | ) |
Write-offs, net of recoveries | |
| (40,000 | ) |
Balance at June 30, 2024 | |
$ | 235,000 | |
|
Fair Value Measurements |
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 1,982,000 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.
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
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
Carrying Value | | |
Fair Value | | |
Carrying Value | | |
Fair Value | |
2026 Notes | |
$ | 73,607,000 | | |
$ | 76,470,000 | | |
$ | 73,218,000 | | |
$ | 70,260,000 | |
2027 Notes | |
$ | 37,770,000 | | |
$ | 43,019,000 | | |
$ | 37,413,000 | | |
$ | 40,363,000 | |
Oaktree Loan | |
$ | 73,646,000 | | |
$ | 77,500,000 | | |
$ | 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, 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
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 4,488,940 and 6,131,026
at June 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 June 30, 2024 and 2023 was 181,038 and 234,027, 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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended June 30, | | |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Numerator – net loss | |
$ | (6,473,000 | ) | |
$ | (4,229,000 | ) | |
$ | (20,038,000 | ) | |
$ | (10,872,000 | ) |
Denominator – weighted average number of shares outstanding, basic and diluted | |
| 35,618,977 | | |
| 30,458,677 | | |
| 35,544,312 | | |
| 30,379,354 | |
Net loss per share, basic and diluted | |
$ | (0.18 | ) | |
$ | (0.14 | ) | |
$ | (0.56 | ) | |
$ | (0.36 | ) |
|
Income Taxes |
Income
Taxes
The
Company’s effective tax rate was 3.38% and (2.71)% for the six months ended June 30, 2024 and 2023, respectively. The Company’s
effective tax rate for the six months ended June 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 (“IRC”), Section 162(m) excess
officer compensation limitation and share-based compensation and the change in valuation allowance.
As
of June 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 |
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 June 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 June 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 June 30, 2024 |
Accounting
Guidance Issued but Not Adopted at June 30, 2024
In
August 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-05,
Business Combinations—Joint Venture Formations (Subtopic 805-60): Recognition and Initial Measurement, which applies to
the formation of entities that meet the definition of a joint venture (or a corporate joint venture) and requires joint ventures to initially
measure all contributions received upon formation at fair value. The new guidance does not impact accounting by the venturers. The new
guidance is applicable to joint venture entities with a formation date on or after January 1, 2025 on a prospective basis. Joint ventures
formed prior to the effective date may elect to apply the new guidance retrospectively back to their original formation date. The Company
will apply the guidance in ASU 2023-05 prospectively to any future arrangements meeting the definition of a joint venture.
In
October 2023, FASB issued 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
in 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.
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
SCHEDULE OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS |
SCHEDULE
OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS
Balance at January 1, 2024 | |
$ | 371,000 | |
Change in expected credit losses | |
| (96,000 | ) |
Write-offs, net of recoveries | |
| (40,000 | ) |
Balance at June 30, 2024 | |
$ | 235,000 | |
|
SCHEDULE OF ESTIMATED FAIR VALUE |
The
following table presents the estimated fair values and the carrying values:
SCHEDULE
OF ESTIMATED FAIR VALUE
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
Carrying Value | | |
Fair Value | | |
Carrying Value | | |
Fair Value | |
2026 Notes | |
$ | 73,607,000 | | |
$ | 76,470,000 | | |
$ | 73,218,000 | | |
$ | 70,260,000 | |
2027 Notes | |
$ | 37,770,000 | | |
$ | 43,019,000 | | |
$ | 37,413,000 | | |
$ | 40,363,000 | |
Oaktree Loan | |
$ | 73,646,000 | | |
$ | 77,500,000 | | |
$ | 72,541,000 | | |
$ | 76,627,000 | |
|
SCHEDULE OF BASIC NET LOSS PER SHARE OF COMMON STOCK |
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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended June 30, | | |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Numerator – net loss | |
$ | (6,473,000 | ) | |
$ | (4,229,000 | ) | |
$ | (20,038,000 | ) | |
$ | (10,872,000 | ) |
Denominator – weighted average number of shares outstanding, basic and diluted | |
| 35,618,977 | | |
| 30,458,677 | | |
| 35,544,312 | | |
| 30,379,354 | |
Net loss per share, basic and diluted | |
$ | (0.18 | ) | |
$ | (0.14 | ) | |
$ | (0.56 | ) | |
$ | (0.36 | ) |
|
Melt Pharmaceuticals, Inc. [Member] |
|
SCHEDULE OF INVESTMENT |
The
following table summarizes the Company’s investments in Melt as of June 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 | ) | |
$ | - | |
|
X |
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v3.24.2.u1
REVENUES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Revenue from Contract with Customer [Abstract] |
|
SCHEDULE OF DISAGGREGATED REVENUE |
Revenue
disaggregated by revenue source consisted of the following:
SCHEDULE OF DISAGGREGATED REVENUE
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended | | |
For the Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Product sales, net | |
$ | 48,871,000 | | |
$ | 29,542,000 | | |
$ | 83,379,000 | | |
$ | 49,995,000 | |
Other revenues | |
| 68,000 | | |
| 3,928,000 | | |
| 147,000 | | |
| 9,578,000 | |
Total revenues | |
$ | 48,939,000 | | |
$ | 33,470,000 | | |
$ | 83,526,000 | | |
$ | 59,573,000 | |
|
X |
- DefinitionTabular disclosure of disaggregation of revenue into categories depicting how nature, amount, timing, and uncertainty of revenue and cash flows are affected by economic factor.
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v3.24.2.u1
INVESTMENT IN, AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC. - RELATED PARTY TRANSACTIONS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Investments, Debt and Equity Securities [Abstract] |
|
SCHEDULE OF CONDENSED INCOME STATEMENT |
The
unaudited condensed results of operations information of Melt is summarized below:
SCHEDULE
OF CONDENSED INCOME STATEMENT
| |
2024 | | |
2023 | |
| |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Revenues, net | |
$ | - | | |
$ | - | |
Loss from operations | |
$ | (5,631,000 | ) | |
$ | (2,448,000 | ) |
Net loss | |
$ | (5,344,000 | ) | |
$ | (3,551,000 | ) |
|
SCHEDULE OF CONDENSED BALANCE SHEET |
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE
OF CONDENSED BALANCE SHEET
| |
2024 | | |
2023 | |
| |
At June 30, | | |
At December 31, | |
| |
2024 | | |
2023 | |
Current assets | |
$ | 11,284,000 | | |
$ | 13,404,000 | |
Non-current assets | |
| - | | |
| - | |
Total assets | |
$ | 11,284,000 | | |
$ | 13,404,000 | |
| |
| | | |
| | |
Total liabilities | |
$ | 3,794,000 | | |
$ | 3,922,000 | |
Total stockholders’ equity | |
| 7,490,000 | | |
| 9,482,000 | |
Total liabilities and stockholders’ equity | |
$ | 11,284,000 | | |
$ | 13,404,000 | |
|
X |
- DefinitionTabular disclosure of condensed balance sheet, including, but not limited to, balance sheets of consolidated entities and consolidation eliminations.
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v3.24.2.u1
INVENTORIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Inventory Disclosure [Abstract] |
|
SCHEDULE OF 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 June 30,
2024 | | |
At December 31,
2023 | |
Raw materials | |
$ | 4,964,000 | | |
$ | 5,477,000 | |
Work in progress | |
| 137,000 | | |
| 54,000 | |
Finished goods | |
| 4,324,000 | | |
| 5,336,000 | |
Total inventories | |
$ | 9,425,000 | | |
$ | 10,867,000 | |
|
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- DefinitionTabular disclosure of the carrying amount as of the balance sheet date of merchandise, goods, commodities, or supplies held for future sale or to be used in manufacturing, servicing or production process.
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v3.24.2.u1
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
SCHEDULE OF 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 June 30,
2024 | | |
At December 31,
2023 | |
Prepaid insurance | |
$ | 306,000 | | |
$ | 1,241,000 | |
Prepaid computer software licenses and related expenses | |
| 952,000 | | |
| 963,000 | |
Other prepaid expenses | |
| 2,470,000 | | |
| 1,556,000 | |
Receivable due from Melt | |
| 228,000 | | |
| 228,000 | |
Prepaid FY 2024 Prescription Drug User (“PDUFA”) fees | |
| 1,146,000 | | |
| 3,438,000 | |
Deferred Oaktree Loan commitment fee | |
| 454,000 | | |
| 409,000 | |
Deposits and other current assets | |
| 1,453,000 | | |
| 1,753,000 | |
Total prepaid expenses and other current assets | |
$ | 7,009,000 | | |
$ | 9,588,000 | |
|
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v3.24.2.u1
PROPERTY, PLANT AND EQUIPMENT (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT |
Property,
plant and equipment consisted of the following:
SCHEDULE
OF PROPERTY, PLANT AND EQUIPMENT
| |
At June 30,
2024 | | |
At December 31,
2023 | |
Property, plant and equipment, net: | |
| | | |
| | |
Computer hardware | |
$ | 1,434,000 | | |
$ | 1,322,000 | |
Furniture and equipment | |
| 942,000 | | |
| 936,000 | |
Lab and pharmacy equipment | |
| 4,737,000 | | |
| 4,564,000 | |
Leasehold improvements | |
| 6,844,000 | | |
| 6,771,000 | |
Property, plant and equipment, gross | |
| 13,957,000 | | |
| 13,593,000 | |
Accumulated depreciation | |
| (10,669,000 | ) | |
| (10,072,000 | ) |
Property, plant and equipment,
net | |
$ | 3,288,000 | | |
$ | 3,521,000 | |
|
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v3.24.2.u1
CAPITALIZED SOFTWARE COSTS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Capitalized Software Costs |
|
SCHEDULE OF CAPITALIZED SOFTWARE COSTS |
Capitalized
software costs consisted of the following:
SCHEDULE OF CAPITALIZED SOFTWARE COSTS
| |
At June 30,
2024 | | |
At December 31,
2023 | |
Capitalized software costs | |
| | | |
| | |
Capitalized internal-use software development costs | |
$ | 3,318,000 | | |
$ | 2,780,000 | |
Acquired third-party software license for internal-use | |
| 204,000 | | |
| 159,000 | |
Total gross capitalized software for internal-use | |
| 3,522,000 | | |
| 2,939,000 | |
Accumulated amortization | |
| (1,556,000 | ) | |
| (1,268,000 | ) |
Capitalized internal-use software in process | |
| - | | |
| 467,000 | |
Total capitalized software
costs net | |
$ | 1,966,000 | | |
$ | 2,138,000 | |
|
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v3.24.2.u1
INTANGIBLE ASSETS AND GOODWILL (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
SCHEDULE OF INTANGIBLE ASSETS |
The
Company’s intangible assets at June 30, 2024 consisted of the following:
SCHEDULE OF INTANGIBLE ASSETS
| |
Amortization Periods (in years) | |
Cost | | |
Accumulated Amortization | | |
Disposal | | |
Net Carrying Value | |
Patents | |
7-19 | |
$ | 610,000 | | |
$ | (188,000 | ) | |
$ | - | | |
$ | 422,000 | |
Licenses | |
7-20 | |
| 50,000 | | |
| (2,000 | ) | |
| - | | |
| 48,000 | |
Trademarks | |
Indefinite | |
| 234,000 | | |
| - | | |
| - | | |
| 234,000 | |
Acquired NDAs | |
4-15 | |
| 170,398,000 | | |
| (16,352,000 | ) | |
| - | | |
| 154,046,000 | |
Customer relationships | |
3-15 | |
| 596,000 | | |
| (536,000 | ) | |
| - | | |
| 60,000 | |
Trade name | |
5 | |
| 75,000 | | |
| (6,000 | ) | |
| - | | |
| 69,000 | |
Non-competition clause | |
3-4 | |
| 50,000 | | |
| (50,000 | ) | |
| - | | |
| - | |
State pharmacy licenses | |
25 | |
| 8,000 | | |
| (3,000 | ) | |
| - | | |
| 5,000 | |
| |
| |
$ | 172,021,000 | | |
$ | (17,137,000 | ) | |
$ | - | | |
$ | 154,884,000 | |
|
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS |
Amortization
expense for intangible assets was as follows:
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended | | |
For the Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Patents | |
$ | 14,000 | | |
$ | 21,000 | | |
$ | 28,000 | | |
$ | 43,000 | |
Licenses | |
| - | | |
| 3,000 | | |
| - | | |
| 5,000 | |
Acquired NDAs | |
| 2,529,000 | | |
| 2,805,000 | | |
| 5,059,000 | | |
| 4,975,000 | |
Customer relationships | |
| 6,000 | | |
| 14,000 | | |
| 16,000 | | |
| 27,000 | |
Amortization
expense of intangible assets | |
$ | 2,549,000 | | |
$ | 2,843,000 | | |
$ | 5,103,000 | | |
$ | 5,050,000 | |
|
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE |
Estimated
future amortization expenses for the Company’s intangible assets at June 30, 2024 was as follows:
SCHEDULE
OF ESTIMATED FUTURE AMORTIZATION EXPENSE
| |
| | |
Remainder of 2024 | |
$ | 5,098,000 | |
2025 | |
| 13,658,000 | |
2026 | |
| 13,658,000 | |
2027 | |
| 13,309,000 | |
2028 | |
| 12,961,000 | |
Thereafter | |
| 95,966,000 | |
Intangible
assets | |
$ | 154,650,000 | |
|
X |
- DefinitionTabular disclosure of amortization expense of assets, excluding financial assets, that lack physical substance, having a limited useful life.
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v3.24.2.u1
ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES |
Accounts
payable and accrued expenses consisted of the following:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
| |
At June 30, | | |
At December 31, | |
| |
2024 | | |
2023 | |
Accounts payable | |
$ | 20,177,000 | | |
$ | 21,424,000 | |
Accrued insurance premium | |
| - | | |
| 873,000 | |
Other accrued payments | |
| 106,000 | | |
| 306,000 | |
Accrued interest (see Note 11) | |
| 1,981,000 | | |
| 1,978,000 | |
Accrued exit fee for Oaktree Loan (see Note 11) | |
| 2,713,000 | | |
| 2,713,000 | |
Total accounts payable and accrued expenses | |
$ | 24,977,000 | | |
$ | 27,294,000 | |
Less: current portion | |
| (22,264,000 | ) | |
| (24,581,000 | ) |
Non-current total accrued expenses | |
$ | 2,713,000 | | |
$ | 2,713,000 | |
|
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v3.24.2.u1
DEBT (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
SCHEDULE OF LONG TERM DEBT |
A
summary of the Company’s debt is described as follows:
SCHEDULE OF LONG TERM DEBT
| |
At June 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 | |
| (7,727,000 | ) | |
| (9,578,000 | ) |
Notes payable net | |
$ | 185,023,000 | | |
$ | 183,172,000 | |
|
SCHEDULE OF FUTURE MINIMUM PAYMENT UNDER NOTES PAYABLES |
At
June 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 | |
$ | 10,674,000 | |
2025 | |
| 20,658,000 | |
2026 | |
| 159,899,000 | |
2027 | |
| 45,030,000 | |
Total minimum payments | |
| 236,261,000 | |
Less: amount representing interest payments | |
| (43,511,000 | ) |
Notes payable, gross principal amount due | |
| 192,750,000 | |
Less: unamortized debt issuance costs, net of premium | |
| (7,727,000 | ) |
Notes payable, net of unamortized debt issuance costs | |
$ | 185,023,000 | |
|
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v3.24.2.u1
LEASES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
SCHEDULE OF FUTURE LEASE PAYMENTS UNDER OPERATING LEASES |
Future
lease payments under operating leases as of June 30, 2024 were as follows:
SCHEDULE
OF FUTURE LEASE PAYMENTS UNDER OPERATING LEASES
| |
Operating Leases | |
Remainder of 2024 | |
$ | 655,000 | |
2025 | |
| 1,133,000 | |
2026 | |
| 1,155,000 | |
2027 | |
| 1,014,000 | |
2028 | |
| 699,000 | |
Thereafter | |
| 5,533,000 | |
Total minimum lease payments | |
| 10,189,000 | |
Less: amount representing interest payments | |
| (2,879,000 | ) |
Total operating lease obligations | |
| 7,310,000 | |
Less: current portion, operating lease obligations | |
| (767,000 | ) |
Operating lease obligations, net of current portion | |
$ | 6,543,000 | |
|
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v3.24.2.u1
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
SCHEDULE OF STOCK OPTION PLAN ACTIVITY |
A
summary of stock option activity under the Plans for the six months ended June 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 | |
| 105,500 | | |
$ | 10.13 | | |
| | | |
| | |
Options exercised | |
| (87,696 | ) | |
$ | 6.02 | | |
| | | |
| | |
Options cancelled/forfeited | |
| (79,938 | ) | |
$ | 13.95 | | |
| | | |
| | |
Options outstanding – June 30, 2024 | |
| 2,649,183 | | |
$ | 6.18 | | |
| 3.62 | | |
$ | 39,021,000 | |
Options exercisable | |
| 2,382,865 | | |
$ | 5.62 | | |
| 3.03 | | |
$ | 36,398,000 | |
Options vested and expected to vest | |
| 2,612,254 | | |
$ | 6.10 | | |
| 3.54 | | |
$ | 38,667,000 | |
|
SCHEDULE OF FAIR VALUE ASSUMPTIONS |
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 | |
$ | 6.57 | |
Expected terms (in years) | |
| 6.11 | |
Expected volatility | |
| 68 | % |
Risk-free interest rate | |
| 4.06-4.48 | % |
Dividend yield | |
| - | |
|
SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE |
The
following table summarizes information about stock options outstanding and exercisable at June 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 - $1.73 | |
| 287,852 | | |
| 3.47 | | |
$ | 1.72 | | |
| 287,852 | | |
$ | 1.72 | |
$2.23 | |
| 270,000 | | |
| 2.59 | | |
$ | 2.23 | | |
| 270,000 | | |
$ | 2.23 | |
$2.40 - $2.60 | |
| 23,068 | | |
| 2.51 | | |
$ | 2.58 | | |
| 23,068 | | |
$ | 2.58 | |
$3.95 | |
| 308,500 | | |
| 1.75 | | |
$ | 3.95 | | |
| 308,500 | | |
$ | 3.95 | |
$4.49 - $5.72 | |
| 99,912 | | |
| 4.97 | | |
$ | 5.54 | | |
| 97,978 | | |
$ | 5.53 | |
$6.30 | |
| 285,000 | | |
| 4.64 | | |
$ | 6.30 | | |
| 285,000 | | |
$ | 6.30 | |
$6.75 - $7.26 | |
| 58,406 | | |
| 7.90 | | |
$ | 6.92 | | |
| 26,566 | | |
$ | 6.93 | |
$7.30 | |
| 274,500 | | |
| 5.51 | | |
$ | 7.30 | | |
| 274,500 | | |
$ | 7.30 | |
$7.37 - $7.79 | |
| 191,210 | | |
| 3.68 | | |
$ | 7.50 | | |
| 149,534 | | |
$ | 7.47 | |
$7.87 - $25.86 | |
| 850,735 | | |
| 3.27 | | |
$ | 9.17 | | |
| 659,867 | | |
$ | 8.14 | |
$1.47 - $25.86 | |
| 2,649,183 | | |
| 3.62 | | |
$ | 6.18 | | |
| 2,382,865 | | |
$ | 5.62 | |
|
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY |
A
summary of the Company’s RSU activity and related information for the six months ended June 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 | |
| 213,081 | | |
| 17.22 | |
RSUs vested | |
| (298,016 | ) | |
| 9.51 | |
RSUs cancelled/forfeited | |
| (6,250 | ) | |
| 8.10 | |
RSUs unvested - June 30, 2024 | |
| 271,844 | | |
$ | 15.21 | |
|
SCHEDULE OF PERFORMANCE STOCK UNITS ACTIVITY |
A
summary of the Company’s PSU activity and related information for the six months ended June 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 – June 30, 2024 | |
| 1,567,913 | | |
$ | 18.56 | |
|
SCHEDULE OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES, DIRECTORS AND CONSULTANTS |
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
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended June 30, | | |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Employees - selling, general and administrative | |
$ | 3,579,000 | | |
$ | 4,607,000 | | |
$ | 7,104,000 | | |
$ | 5,935,000 | |
Employees - research and development | |
| 439,000 | | |
| 586,000 | | |
| 878,000 | | |
| 749,000 | |
Directors - selling, general and administrative | |
| 214,000 | | |
| 203,000 | | |
| 402,000 | | |
| 328,000 | |
Consultants - selling, general and administrative | |
| 39,000 | | |
| 16,000 | | |
| 56,000 | | |
| 33,000 | |
Total | |
$ | 4,271,000 | | |
$ | 5,412,000 | | |
$ | 8,440,000 | | |
$ | 7,045,000 | |
|
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v3.24.2.u1
SCHEDULE OF ESTIMATED FAIR VALUE (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Platform Operator, Crypto Asset [Line Items] |
|
|
Carrying value |
$ 192,750,000
|
$ 192,750,000
|
Oaktree Loan [Member] |
|
|
Platform Operator, Crypto Asset [Line Items] |
|
|
Carrying value |
77,500,000
|
77,500,000
|
Fair Value, Inputs, Level 1 [Member] | 2026 Notes [Member] |
|
|
Platform Operator, Crypto Asset [Line Items] |
|
|
Carrying value |
73,607,000
|
73,218,000
|
Fair value |
76,470,000
|
70,260,000
|
Fair Value, Inputs, Level 1 [Member] | 2027 Notes [Member] |
|
|
Platform Operator, Crypto Asset [Line Items] |
|
|
Carrying value |
37,770,000
|
37,413,000
|
Fair value |
43,019,000
|
40,363,000
|
Fair Value, Inputs, Level 2 [Member] | Oaktree Loan [Member] |
|
|
Platform Operator, Crypto Asset [Line Items] |
|
|
Carrying value |
73,646,000
|
72,541,000
|
Fair value |
$ 77,500,000
|
$ 76,627,000
|
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v3.24.2.u1
SCHEDULE OF BASIC NET LOSS PER SHARE OF COMMON STOCK (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
|
|
|
Numerator – net loss |
$ (6,473,000)
|
$ (4,229,000)
|
$ (20,038,000)
|
$ (10,872,000)
|
Denominator - weighted average number of shares outstanding, basic |
35,618,977
|
30,458,677
|
35,544,312
|
30,379,354
|
Denominator - weighted average number of shares outstanding, diluted |
35,618,977
|
30,458,677
|
35,544,312
|
30,379,354
|
Net loss per share, basic |
$ (0.18)
|
$ (0.14)
|
$ (0.56)
|
$ (0.36)
|
Net loss per share, diluted |
$ (0.18)
|
$ (0.14)
|
$ (0.56)
|
$ (0.36)
|
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v3.24.2.u1
SCHEDULE OF INVESTMENT (Details) - Melt Pharmaceuticals, Inc. [Member]
|
6 Months Ended |
Jun. 30, 2024
USD ($)
|
Schedule of Investments [Line Items] |
|
Cost basis |
$ 24,207,000
|
Share of Equity Method Losses |
(24,207,000)
|
Net Carrying Value |
|
Common Stock [Member] |
|
Schedule of Investments [Line Items] |
|
Cost basis |
5,810,000
|
Share of Equity Method Losses |
(5,810,000)
|
Net Carrying Value |
|
Preferred Stock [Member] |
|
Schedule of Investments [Line Items] |
|
Cost basis |
18,397,000
|
Share of Equity Method Losses |
(18,397,000)
|
Net Carrying Value |
|
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v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
Apr. 30, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Accounts receivable |
|
$ 52,727,000
|
|
$ 52,727,000
|
|
|
Accounts receivable, net of allowances for credit losses |
|
235,000
|
|
235,000
|
|
|
Loss on sale of investments |
|
1,923,000
|
$ 714,000
|
$ 3,171,000
|
$ (1,328,000)
|
|
Effective income tax rate |
|
|
|
3.38%
|
(2.71%)
|
|
Federal income tax rate |
|
|
|
21.00%
|
21.00%
|
|
Unrecognized tax benefits |
|
$ 0
|
|
$ 0
|
|
$ 0
|
Melt Pharmaceuticals, Inc. [Member] |
|
|
|
|
|
|
Ownership percentage |
|
46.00%
|
|
46.00%
|
|
|
Melt Pharmaceuticals, Inc. [Member] | Common Stock [Member] |
|
|
|
|
|
|
Investment owned balance shares |
|
3,500,000
|
|
3,500,000
|
|
|
Melt Pharmaceuticals, Inc. [Member] | Preferred Stock [Member] |
|
|
|
|
|
|
Investment owned balance shares |
|
2,334,256
|
|
2,334,256
|
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
Number of shares vested |
|
|
|
$ 181,038
|
$ 234,027
|
|
Stock Options, Unvested RSUs And Unvested PSUs [Member] |
|
|
|
|
|
|
Stock excluded in calculation of diluted net loss per common share |
|
|
|
4,488,940
|
6,131,026
|
|
Eton Pharmaceuticals, Inc. [Member] |
|
|
|
|
|
|
Investment owned at fair value |
|
|
|
|
|
$ 8,681,000
|
Trading and commissions expenses |
$ 436,000
|
|
|
|
|
|
Net proceeds from issuance of shares |
$ 5,510,000
|
|
|
|
|
|
Eton Pharmaceuticals, Inc. [Member] | Common Stock [Member] |
|
|
|
|
|
|
Number of shares sold |
1,982,000
|
|
|
|
|
|
Gross price |
$ 3.00
|
|
|
|
|
|
X |
- DefinitionAmount, after allowance for credit loss, of right to consideration from customer for product sold and service rendered in normal course of business.
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v3.24.2.u1
SCHEDULE OF DISAGGREGATED REVENUE (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
$ 48,939,000
|
$ 33,470,000
|
$ 83,526,000
|
$ 59,573,000
|
Product Sales, Net [Member] |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
48,871,000
|
29,542,000
|
83,379,000
|
49,995,000
|
Other Revenues [Member] |
|
|
|
|
Disaggregation of Revenue [Line Items] |
|
|
|
|
Total revenues |
$ 68,000
|
$ 3,928,000
|
$ 147,000
|
$ 9,578,000
|
X |
- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
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v3.24.2.u1
SCHEDULE OF CONDENSED INCOME STATEMENT (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Revenues, net |
$ 48,939,000
|
$ 33,470,000
|
$ 83,526,000
|
$ 59,573,000
|
Loss from operations |
1,530,000
|
2,352,000
|
(5,398,000)
|
3,562,000
|
Net loss |
$ (6,473,000)
|
$ (4,229,000)
|
(20,038,000)
|
(10,872,000)
|
Melt Pharmaceuticals, Inc. [Member] |
|
|
|
|
Revenues, net |
|
|
|
|
Loss from operations |
|
|
(5,631,000)
|
(2,448,000)
|
Net loss |
|
|
$ (5,344,000)
|
$ (3,551,000)
|
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v3.24.2.u1
SCHEDULE OF CONDENSED BALANCE SHEET (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets |
$ 139,390,000
|
$ 139,482,000
|
Total assets |
306,630,000
|
312,164,000
|
Total liabilities |
248,453,000
|
241,753,000
|
Total stockholders’ equity |
58,532,000
|
70,766,000
|
Total liabilities and stockholders’ equity |
306,630,000
|
312,164,000
|
Melt Pharmaceuticals, Inc. [Member] |
|
|
Current assets |
11,284,000
|
13,404,000
|
Non-current assets |
|
|
Total assets |
11,284,000
|
13,404,000
|
Total liabilities |
3,794,000
|
3,922,000
|
Total stockholders’ equity |
7,490,000
|
9,482,000
|
Total liabilities and stockholders’ equity |
$ 11,284,000
|
$ 13,404,000
|
X |
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INVESTMENT IN, AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC. - RELATED PARTY TRANSACTIONS (Details Narrative) - Melt Pharmaceuticals, Inc. [Member] - USD ($)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
|
Mar. 31, 2024 |
Feb. 28, 2019 |
Jun. 30, 2023 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Dec. 31, 2023 |
Reimbursable expenses |
|
|
$ 30,000
|
$ 40,000
|
|
|
Due from related party |
|
|
|
|
$ 228,000
|
$ 228,000
|
Series B Preferred Stock [Member] |
|
|
|
|
|
|
Gross proceeds from stock financing |
$ 23,900,000
|
|
|
|
|
|
Management Services Agreement [Member] |
|
|
|
|
|
|
Administrative fees expense |
|
$ 10,000
|
|
|
|
|
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v3.24.2.u1
SCHEDULE OF INVENTORIES (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Inventory Disclosure [Abstract] |
|
|
Raw materials |
$ 4,964,000
|
$ 5,477,000
|
Work in progress |
137,000
|
54,000
|
Finished goods |
4,324,000
|
5,336,000
|
Total inventories |
$ 9,425,000
|
$ 10,867,000
|
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v3.24.2.u1
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
|
Prepaid insurance |
$ 306,000
|
$ 1,241,000
|
Prepaid computer software licenses and related expenses |
952,000
|
963,000
|
Other prepaid expenses |
2,470,000
|
1,556,000
|
Receivable due from Melt |
228,000
|
228,000
|
Prepaid FY 2024 Prescription Drug User (“PDUFA”) fees |
1,146,000
|
3,438,000
|
Deferred Oaktree Loan commitment fee |
454,000
|
409,000
|
Deposits and other current assets |
1,453,000
|
1,753,000
|
Total prepaid expenses and other current assets |
$ 7,009,000
|
$ 9,588,000
|
X |
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SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Abstract] |
|
|
Computer hardware |
$ 1,434,000
|
$ 1,322,000
|
Furniture and equipment |
942,000
|
936,000
|
Lab and pharmacy equipment |
4,737,000
|
4,564,000
|
Leasehold improvements |
6,844,000
|
6,771,000
|
Property, plant and equipment, gross |
13,957,000
|
13,593,000
|
Accumulated depreciation |
(10,669,000)
|
(10,072,000)
|
Property, plant and equipment, net |
$ 3,288,000
|
$ 3,521,000
|
X |
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PROPERTY, PLANT AND EQUIPMENT (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
|
|
|
Depreciation expenses |
$ 301,000
|
$ 228,000
|
$ 597,000
|
$ 453,000
|
X |
- DefinitionThe amount of expense recognized in the current period that reflects the allocation of the cost of tangible assets over the assets' useful lives. Includes production and non-production related depreciation.
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v3.24.2.u1
SCHEDULE OF CAPITALIZED SOFTWARE COSTS (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Finite-Lived Intangible Assets [Line Items] |
|
|
Total gross capitalized software for internal-use |
$ 3,522,000
|
$ 2,939,000
|
Accumulated amortization |
(1,556,000)
|
(1,268,000)
|
Capitalized internal-use software in process |
|
467,000
|
Total capitalized software costs net |
1,966,000
|
2,138,000
|
Capitalized Software Development Costs [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Total gross capitalized software for internal-use |
3,318,000
|
2,780,000
|
Third Party Software License [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Total gross capitalized software for internal-use |
$ 204,000
|
$ 159,000
|
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v3.24.2.u1
SCHEDULE OF INTANGIBLE ASSETS (Details) - USD ($)
|
6 Months Ended |
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Cost |
$ 172,021,000
|
|
Intangible assets, Accumulated amortization |
(17,137,000)
|
|
Intangible assets, Disposal |
|
|
Intangible assets, Net Carrying value |
154,884,000
|
$ 159,906,000
|
Patents [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Cost |
610,000
|
|
Intangible assets, Accumulated amortization |
(188,000)
|
|
Intangible assets, Disposal |
|
|
Intangible assets, Net Carrying value |
422,000
|
|
Licenses [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Cost |
50,000
|
|
Intangible assets, Accumulated amortization |
(2,000)
|
|
Intangible assets, Disposal |
|
|
Intangible assets, Net Carrying value |
48,000
|
|
Trademarks [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Cost |
234,000
|
|
Intangible assets, Accumulated amortization |
|
|
Intangible assets, Disposal |
|
|
Intangible assets, Net Carrying value |
$ 234,000
|
|
Useful life, description |
Indefinite
|
|
New Drug Applications [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Cost |
$ 170,398,000
|
|
Intangible assets, Accumulated amortization |
(16,352,000)
|
|
Intangible assets, Disposal |
|
|
Intangible assets, Net Carrying value |
154,046,000
|
|
Customer Relationships [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Cost |
596,000
|
|
Intangible assets, Accumulated amortization |
(536,000)
|
|
Intangible assets, Disposal |
|
|
Intangible assets, Net Carrying value |
$ 60,000
|
|
Trade Names [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Useful life |
5 years
|
|
Intangible assets, Cost |
$ 75,000
|
|
Intangible assets, Accumulated amortization |
(6,000)
|
|
Intangible assets, Disposal |
|
|
Intangible assets, Net Carrying value |
69,000
|
|
Noncompete Agreements [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Cost |
50,000
|
|
Intangible assets, Accumulated amortization |
(50,000)
|
|
Intangible assets, Disposal |
|
|
Intangible assets, Net Carrying value |
|
|
State Pharmacy Licenses [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Useful life |
25 years
|
|
Intangible assets, Cost |
$ 8,000
|
|
Intangible assets, Accumulated amortization |
(3,000)
|
|
Intangible assets, Disposal |
|
|
Intangible assets, Net Carrying value |
$ 5,000
|
|
Minimum [Member] | Patents [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Useful life |
7 years
|
|
Minimum [Member] | Licenses [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Useful life |
7 years
|
|
Minimum [Member] | New Drug Applications [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Useful life |
4 years
|
|
Minimum [Member] | Customer Relationships [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Useful life |
3 years
|
|
Minimum [Member] | Noncompete Agreements [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Useful life |
3 years
|
|
Maximum [Member] | Patents [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Useful life |
19 years
|
|
Maximum [Member] | Licenses [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Intangible assets, Useful life |
20 years
|
|
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v3.24.2.u1
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
Amortization expense of intangible assets |
$ 2,549,000
|
$ 2,843,000
|
$ 5,103,000
|
$ 5,050,000
|
Patents [Member] |
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
Amortization expense of intangible assets |
14,000
|
21,000
|
28,000
|
43,000
|
Licenses [Member] |
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
Amortization expense of intangible assets |
|
3,000
|
|
5,000
|
Acquired NDAs [Member] |
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
Amortization expense of intangible assets |
2,529,000
|
2,805,000
|
5,059,000
|
4,975,000
|
Customer Relationships [Member] |
|
|
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
|
|
Amortization expense of intangible assets |
$ 6,000
|
$ 14,000
|
$ 16,000
|
$ 27,000
|
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v3.24.2.u1
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE (Details)
|
Jun. 30, 2024
USD ($)
|
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Remainder of 2024 |
$ 5,098,000
|
2025 |
13,658,000
|
2026 |
13,658,000
|
2027 |
13,309,000
|
2028 |
12,961,000
|
Thereafter |
95,966,000
|
Intangible assets |
$ 154,650,000
|
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v3.24.2.u1
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Payables and Accruals [Abstract] |
|
|
Accounts payable |
$ 20,177,000
|
$ 21,424,000
|
Accrued insurance premium |
|
873,000
|
Other accrued payments |
106,000
|
306,000
|
Accrued interest (see Note 11) |
1,981,000
|
1,978,000
|
Accrued exit fee for Oaktree Loan (see Note 11) |
2,713,000
|
2,713,000
|
Total accounts payable and accrued expenses |
24,977,000
|
27,294,000
|
Less: current portion |
(22,264,000)
|
(24,581,000)
|
Non-current total accrued expenses |
$ 2,713,000
|
$ 2,713,000
|
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|
Jun. 30, 2024 |
Dec. 31, 2023 |
Short-Term Debt [Line Items] |
|
|
Notes payable gross |
$ 192,750,000
|
$ 192,750,000
|
Less: Unamortized debt issuance costs, net of premium |
(7,727,000)
|
(9,578,000)
|
Notes payable net |
185,023,000
|
183,172,000
|
8.625% Senior Notes Due 2026 [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Notes payable gross |
75,000,000
|
75,000,000
|
11.875% Senior Notes Due 2027 [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Notes payable gross |
40,250,000
|
40,250,000
|
Oaktree Loan [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Notes payable gross |
$ 77,500,000
|
$ 77,500,000
|
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v3.24.2.u1
SCHEDULE OF FUTURE MINIMUM PAYMENT UNDER NOTES PAYABLES (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Debt Disclosure [Abstract] |
|
|
Remainder of 2024 |
$ 10,674,000
|
|
2025 |
20,658,000
|
|
2026 |
159,899,000
|
|
2027 |
45,030,000
|
|
Total minimum payments |
236,261,000
|
|
Less: amount representing interest payments |
(43,511,000)
|
|
Notes payable, gross principal amount due |
192,750,000
|
$ 192,750,000
|
Less: unamortized debt issuance costs, net of premium |
(7,727,000)
|
(9,578,000)
|
Notes payable, net of unamortized debt issuance costs |
$ 185,023,000
|
$ 183,172,000
|
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v3.24.2.u1
DEBT (Details Narrative) - USD ($)
|
|
1 Months Ended |
2 Months Ended |
3 Months Ended |
6 Months Ended |
|
|
Mar. 27, 2024 |
Jul. 31, 2023 |
Mar. 31, 2023 |
Jan. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Sep. 30, 2021 |
Dec. 31, 2023 |
Jul. 01, 2023 |
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Amortization of debt issuance costs and debt discount |
|
|
|
|
|
|
$ 1,951,000
|
$ 1,623,000
|
|
|
|
Effective interest rate |
|
|
|
|
10.78%
|
10.71%
|
10.88%
|
10.81%
|
|
|
|
Oaktree Loan [Member] |
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
|
|
$ 2,944,000
|
$ 2,570,000
|
$ 5,897,000
|
$ 2,665,000
|
|
|
|
Amortization of debt issuance costs and debt discount |
|
|
|
|
$ 602,000
|
514,000
|
$ 1,205,000
|
526,000
|
|
|
|
Exit fee percentage |
|
|
|
|
3.50%
|
|
3.50%
|
|
|
|
|
Accrued exit fee liability |
|
|
|
|
$ 2,713,000
|
|
$ 2,713,000
|
|
|
$ 2,713,000
|
|
Maturity period |
|
|
|
|
|
|
January 2026
|
|
|
|
|
11.875% Senior Notes Due 2027 [Member] |
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
|
|
1,373,000
|
1,371,000
|
$ 2,746,000
|
2,766,000
|
|
|
|
Amortization of debt issuance costs and debt discount |
|
|
|
|
$ 178,000
|
176,000
|
$ 356,000
|
376,000
|
|
|
|
Face amount |
|
|
|
$ 40,250,000
|
|
|
|
|
|
|
|
Interest rate |
|
|
|
11.875%
|
11.875%
|
|
11.875%
|
|
|
|
|
Maturity period |
|
|
|
December
2027
|
|
|
December 2027
|
|
|
|
|
8.625% Senior Notes Due 2026 [Member] |
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
|
|
$ 1,812,000
|
1,812,000
|
$ 3,624,000
|
3,622,000
|
|
|
|
Amortization of debt issuance costs and debt discount |
|
|
|
|
$ 195,000
|
195,000
|
$ 390,000
|
388,000
|
|
|
|
Face amount |
|
|
|
|
|
|
|
|
$ 75,000,000
|
|
|
Interest rate |
|
|
|
|
8.625%
|
|
8.625%
|
|
8.625%
|
|
|
Maturity period |
|
|
|
|
|
|
April 2026
|
|
April 2026
|
|
|
Oaktree Loan [Member] | Oaktree Fund Administration LLC [Member] |
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Principal amount drawn |
|
$ 12,500,000
|
$ 65,000,000
|
|
|
|
|
|
|
|
|
Oaktree Loan [Member] | Oaktree Fund Administration LLC [Member] | Tranche B [Member] |
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Loan maximum borrowing capacity |
$ 30,000,000
|
$ 35,000,000
|
|
|
|
|
|
|
|
|
|
Commitment fee percentage for undrawn amount |
2.00%
|
|
|
|
|
|
|
|
|
|
|
Oaktree Loan [Member] | Oaktree Fund Administration LLC [Member] | Senior Secured Term Loan [Member] |
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Loan maximum borrowing capacity |
|
|
$ 100,000,000
|
|
|
|
|
|
|
|
|
Oaktree Credit Agreement Amendment [Member] |
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Loan maximum borrowing capacity |
|
|
|
|
|
$ 100,000,000
|
|
$ 100,000,000
|
|
|
$ 112,500,000
|
X |
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v3.24.2.u1
SCHEDULE OF FUTURE LEASE PAYMENTS UNDER OPERATING LEASES (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Leases |
|
|
Remainder of 2024 |
$ 655,000
|
|
2025 |
1,133,000
|
|
2026 |
1,155,000
|
|
2027 |
1,014,000
|
|
2028 |
699,000
|
|
Thereafter |
5,533,000
|
|
Total minimum lease payments |
10,189,000
|
|
Less: amount representing interest payments |
(2,879,000)
|
|
Total operating lease obligations |
7,310,000
|
|
Less: current portion, operating lease obligations |
(767,000)
|
$ (806,000)
|
Operating lease obligations, net of current portion |
$ 6,543,000
|
$ 6,524,000
|
X |
- References
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v3.24.2.u1
LEASES (Details Narrative)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
Mar. 31, 2024
ft²
|
Jan. 31, 2024
ft²
|
Sep. 30, 2022
ft²
|
Jan. 31, 2022
ft²
|
May 31, 2021
ft²
|
Jul. 31, 2020
ft²
|
Jan. 31, 2020
ft²
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2023
USD ($)
|
Weighted average incremental borrowing rate |
|
|
|
|
|
|
|
6.60%
|
|
6.60%
|
|
Weighted average remaining lease term |
|
|
|
|
|
|
|
11 years 2 months 12 days
|
|
11 years 2 months 12 days
|
|
Cash paid for amounts included for operating lease liabilities | $ |
|
|
|
|
|
|
|
$ 327,000
|
$ 306,000
|
$ 650,000
|
$ 611,000
|
Selling, General and Administrative Expenses [Member] |
|
|
|
|
|
|
|
|
|
|
|
Operating lease expense | $ |
|
|
|
|
|
|
|
$ 319,000
|
$ 308,000
|
$ 638,000
|
$ 617,000
|
Carlsbad [Member] |
|
|
|
|
|
|
|
|
|
|
|
Lease area |
|
|
|
5,789
|
|
|
|
|
|
|
|
Lease expiration date, description |
|
|
|
March 2025
|
|
|
|
|
|
|
|
Ledgewood [Member] |
|
|
|
|
|
|
|
|
|
|
|
Lease area |
|
|
|
|
|
38,153
|
|
|
|
|
|
Lease expiration date, description |
|
|
|
|
|
July 2027
|
|
|
|
|
|
Lease, extension description |
|
|
|
|
|
option to extend the term for two additional five-year periods
|
|
|
|
|
|
Ledgewood [Member] | Lease Amendment [Member] |
|
|
|
|
|
|
|
|
|
|
|
Lease expiration date, description |
|
|
|
|
July 2027
|
|
|
|
|
|
|
Area of land |
|
2,861
|
|
|
8,900
|
1,400
|
|
|
|
|
|
Nashville [Member] |
|
|
|
|
|
|
|
|
|
|
|
Lease area |
17,625
|
|
11,552
|
|
|
|
5,500
|
|
|
|
|
Lease expiration date, description |
|
|
September 2027
|
|
|
|
December 2024
|
|
|
|
|
Lease, extension description |
|
|
|
|
|
|
option to extend the term for two additional five-year periods
|
|
|
|
|
Lease not yet commenced, term |
7 years
|
|
|
|
|
|
|
|
|
|
|
Lease expiration date |
Jun. 30, 2032
|
|
|
|
|
|
|
|
|
|
|
Lease not yet commenced, extension description |
option to extend the term for
two additional five-year periods
|
|
|
|
|
|
|
|
|
|
|
Minimum [Member] | Office and Laboratory Space [Member] |
|
|
|
|
|
|
|
|
|
|
|
Lease term |
|
|
|
|
|
|
|
1 year
|
|
1 year
|
|
Maximum [Member] | Office and Laboratory Space [Member] |
|
|
|
|
|
|
|
|
|
|
|
Lease term |
|
|
|
|
|
|
|
7 years
|
|
7 years
|
|
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v3.24.2.u1
SCHEDULE OF STOCK OPTION PLAN ACTIVITY (Details) - Stock Option Plan [Member]
|
6 Months Ended |
Jun. 30, 2024
USD ($)
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of shares, outstanding, beginning balance | shares |
2,711,317
|
Weighted average exercise price, outstanding, beginning balance | $ / shares |
$ 6.25
|
Number of shares, options granted | shares |
105,500
|
Weighted average exercise price, options granted | $ / shares |
$ 10.13
|
Number of shares, options exercised | shares |
(87,696)
|
Weighted average exercise price, options exercised | $ / shares |
$ 6.02
|
Number of shares, options cancelled/forfeited | shares |
(79,938)
|
Weighted average exercise price, options cancelled/forfeited | $ / shares |
$ 13.95
|
Number of shares, outstanding, ending balance | shares |
2,649,183
|
Weighted average exercise price, outstanding, ending balance | $ / shares |
$ 6.18
|
Weighted average. remaining contractual life, options outstanding |
3 years 7 months 13 days
|
Aggregate intrinsic value, options outstanding | $ |
$ 39,021,000
|
Number of shares, options exercisable | shares |
2,382,865
|
Weighted average exercise price, options exercisable | $ / shares |
$ 5.62
|
Weighted average. remaining contractual life, options exercisable |
3 years 10 days
|
Aggregate intrinsic value, options exercisable | $ |
$ 36,398,000
|
Number of shares, options vested and expected to vest | shares |
2,612,254
|
Weighted average exercise price, options vested and expected to vest | $ / shares |
$ 6.10
|
Weighted average. remaining contractual life, options vested and expected to vest |
3 years 6 months 14 days
|
Aggregate intrinsic value, options exercisable | $ |
$ 38,667,000
|
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v3.24.2.u1
SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE (Details)
|
6 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Range of Exercise Prices, minimum |
$ 1.47
|
Range of Exercise Prices, maximum |
$ 25.86
|
Number of Options Outstanding | shares |
2,649,183
|
Weighted Average Remaining Contractual Life in Years |
3 years 7 months 13 days
|
Weighted Average Exercise Price, Outstanding |
$ 6.18
|
Number of Options Exercisable | shares |
2,382,865
|
Weighted Average Exercise Price, Exercisable |
$ 5.62
|
Range One [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Range of Exercise Prices, minimum |
1.47
|
Range of Exercise Prices, maximum |
$ 1.73
|
Number of Options Outstanding | shares |
287,852
|
Weighted Average Remaining Contractual Life in Years |
3 years 5 months 19 days
|
Weighted Average Exercise Price, Outstanding |
$ 1.72
|
Number of Options Exercisable | shares |
287,852
|
Weighted Average Exercise Price, Exercisable |
$ 1.72
|
Range Two [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Range of Exercise Prices, maximum |
$ 2.23
|
Number of Options Outstanding | shares |
270,000
|
Weighted Average Remaining Contractual Life in Years |
2 years 7 months 2 days
|
Weighted Average Exercise Price, Outstanding |
$ 2.23
|
Number of Options Exercisable | shares |
270,000
|
Weighted Average Exercise Price, Exercisable |
$ 2.23
|
Range Three [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Range of Exercise Prices, minimum |
2.40
|
Range of Exercise Prices, maximum |
$ 2.60
|
Number of Options Outstanding | shares |
23,068
|
Weighted Average Remaining Contractual Life in Years |
2 years 6 months 3 days
|
Weighted Average Exercise Price, Outstanding |
$ 2.58
|
Number of Options Exercisable | shares |
23,068
|
Weighted Average Exercise Price, Exercisable |
$ 2.58
|
Range Four [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Range of Exercise Prices, maximum |
$ 3.95
|
Number of Options Outstanding | shares |
308,500
|
Weighted Average Remaining Contractual Life in Years |
1 year 9 months
|
Weighted Average Exercise Price, Outstanding |
$ 3.95
|
Number of Options Exercisable | shares |
308,500
|
Weighted Average Exercise Price, Exercisable |
$ 3.95
|
Range Five [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Range of Exercise Prices, minimum |
4.49
|
Range of Exercise Prices, maximum |
$ 5.72
|
Number of Options Outstanding | shares |
99,912
|
Weighted Average Remaining Contractual Life in Years |
4 years 11 months 19 days
|
Weighted Average Exercise Price, Outstanding |
$ 5.54
|
Number of Options Exercisable | shares |
97,978
|
Weighted Average Exercise Price, Exercisable |
$ 5.53
|
Range Six [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Range of Exercise Prices, maximum |
$ 6.30
|
Number of Options Outstanding | shares |
285,000
|
Weighted Average Remaining Contractual Life in Years |
4 years 7 months 20 days
|
Weighted Average Exercise Price, Outstanding |
$ 6.30
|
Number of Options Exercisable | shares |
285,000
|
Weighted Average Exercise Price, Exercisable |
$ 6.30
|
Range Seven [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Range of Exercise Prices, minimum |
6.75
|
Range of Exercise Prices, maximum |
$ 7.26
|
Number of Options Outstanding | shares |
58,406
|
Weighted Average Remaining Contractual Life in Years |
7 years 10 months 24 days
|
Weighted Average Exercise Price, Outstanding |
$ 6.92
|
Number of Options Exercisable | shares |
26,566
|
Weighted Average Exercise Price, Exercisable |
$ 6.93
|
Range Eight [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Range of Exercise Prices, maximum |
$ 7.30
|
Number of Options Outstanding | shares |
274,500
|
Weighted Average Remaining Contractual Life in Years |
5 years 6 months 3 days
|
Weighted Average Exercise Price, Outstanding |
$ 7.30
|
Number of Options Exercisable | shares |
274,500
|
Weighted Average Exercise Price, Exercisable |
$ 7.30
|
Range Nine [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Range of Exercise Prices, minimum |
7.37
|
Range of Exercise Prices, maximum |
$ 7.79
|
Number of Options Outstanding | shares |
191,210
|
Weighted Average Remaining Contractual Life in Years |
3 years 8 months 4 days
|
Weighted Average Exercise Price, Outstanding |
$ 7.50
|
Number of Options Exercisable | shares |
149,534
|
Weighted Average Exercise Price, Exercisable |
$ 7.47
|
Range Ten [Member] |
|
Share-Based Payment Arrangement, Option, Exercise Price Range [Line Items] |
|
Range of Exercise Prices, minimum |
7.87
|
Range of Exercise Prices, maximum |
$ 25.86
|
Number of Options Outstanding | shares |
850,735
|
Weighted Average Remaining Contractual Life in Years |
3 years 3 months 7 days
|
Weighted Average Exercise Price, Outstanding |
$ 9.17
|
Number of Options Exercisable | shares |
659,867
|
Weighted Average Exercise Price, Exercisable |
$ 8.14
|
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v3.24.2.u1
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY (Details) - Restricted Stock Units (RSUs) [Member]
|
6 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of Shares, unvested, outstanding, beginning balance | shares |
363,029
|
Weighted average grant date fair value, beginning balance | $ / shares |
$ 9.23
|
Number of Shares, RSUs granted | shares |
213,081
|
Weighted average grant date fair value, RSUs granted | $ / shares |
$ 17.22
|
Number of Shares, RSUs vested | shares |
(298,016)
|
Weighted average grant date fair value, RSUs vested | $ / shares |
$ 9.51
|
Number of Shares, RSUs cancelled/forfeited | shares |
(6,250)
|
Weighted average grant date fair value, RSUs cancelled/forfeited | $ / shares |
$ 8.10
|
Number of Shares, unvested, outstanding, ending balance | shares |
271,844
|
Weighted average grant date fair value, ending balance | $ / shares |
$ 15.21
|
X |
- DefinitionThe number of equity-based payment instruments, excluding stock (or unit) options, that were forfeited during the reporting period.
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|
6 Months Ended |
Jun. 30, 2024
$ / shares
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|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Total |
$ 4,271,000
|
$ 5,412,000
|
$ 8,440,000
|
$ 7,045,000
|
Employees [Member] | Selling, General and Administrative Expenses [Member] |
|
|
|
|
Total |
3,579,000
|
4,607,000
|
7,104,000
|
5,935,000
|
Employees [Member] | Research and Development Expense [Member] |
|
|
|
|
Total |
439,000
|
586,000
|
878,000
|
749,000
|
Director [Member] | Selling, General and Administrative Expenses [Member] |
|
|
|
|
Total |
214,000
|
203,000
|
402,000
|
328,000
|
Consultants [Member] | Selling, General and Administrative Expenses [Member] |
|
|
|
|
Total |
$ 39,000
|
$ 16,000
|
$ 56,000
|
$ 33,000
|
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STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 28, 2024 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Proceeds from stock option exercised |
|
|
$ 521,000
|
$ 337,000
|
|
Exercise price, minimum |
|
|
$ 1.47
|
|
|
Exercise price, maximum |
|
|
$ 25.86
|
|
|
Number of shares issued of common stock |
|
|
|
|
|
Stock-based compensation |
$ 4,271,000
|
5,412,000
|
$ 8,440,000
|
7,045,000
|
|
2017 Incentive Stock and Awards Plan [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Common shares available for future issuances |
173,219
|
|
173,219
|
|
|
2017 Incentive Stock and Awards Plan [Member] | Maximum [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares authorized for issuance |
6,000,000
|
|
6,000,000
|
|
|
Employees and Directors [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Forfeiture factor rate |
|
|
10.00%
|
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Closing price of common stock price per share |
|
|
|
|
$ 20.89
|
Unrecognized compensation expense |
$ 1,723,000
|
|
$ 1,723,000
|
|
|
Weighted-average period for recognition |
|
|
2 years 10 months 6 days
|
|
|
Stock-based compensation |
130,000
|
122,000
|
$ 256,000
|
463,000
|
|
Intrinsic value of options exercised |
|
|
$ 694,000
|
|
|
Share-Based Payment Arrangement, Option [Member] | Employees and Consultant [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Vesting term description |
|
|
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, 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
|
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares granted |
|
|
213,081
|
|
|
Number of shares vested of common stock |
|
|
298,016
|
|
|
Unrecognized compensation expense |
3,945,000
|
|
$ 3,945,000
|
|
|
Weighted-average period for recognition |
|
|
2 years 2 months 12 days
|
|
|
Stock-based compensation |
502,000
|
122,000
|
$ 907,000
|
463,000
|
|
Restricted Stock Units (RSUs) [Member] | Employees [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares vested of common stock |
|
|
50,000
|
|
|
Restricted Stock Units (RSUs) [Member] | Director [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares vested of common stock |
|
|
3,872
|
|
|
Restricted Stock Units (RSUs) [Member] | Andrew R. Boll [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares granted |
|
|
45,000
|
|
|
Restricted Stock Units (RSUs) [Member] | Mark L. Baum [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares granted |
|
|
150,000
|
|
|
Restricted Stock Units (RSUs) [Member] | John Saharek [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares vested of common stock |
|
|
30,000
|
|
|
Performance Shares [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares granted |
|
|
|
|
|
Number of shares vested of common stock |
|
|
|
|
|
Unrecognized compensation expense |
14,553,000
|
|
$ 14,553,000
|
|
|
Weighted-average period for recognition |
|
|
9 months 3 days
|
|
|
Stock-based compensation |
$ 3,638,000
|
$ 5,290,000
|
$ 7,276,000
|
$ 6,582,000
|
|
Common Stock [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares of common stock |
|
|
199
|
|
|
Proceeds from stock option exercised |
|
|
$ 521,000
|
|
|
Options exercise price |
|
10,000
|
700
|
10,000
|
|
Exercise price, minimum |
|
|
$ 1.70
|
|
|
Exercise price, maximum |
|
|
12.38
|
|
|
Exercise price per share |
$ 7.60
|
|
$ 7.60
|
|
|
Number of shares issued of common stock |
|
|
|
|
|
Common Stock [Member] | Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares of common stock |
|
|
86,996
|
|
|
Options exercise price |
|
|
86,996
|
|
|
Common Stock [Member] | Restricted Stock Units (RSUs) [Member] | Employees [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares issued of common stock |
|
|
$ 32,452
|
|
|
Shares withheld for tax withholding obligation, shares |
|
|
17,548
|
|
|
Payroll tax obligations, value |
|
|
$ 187,000
|
|
|
Common Stock [Member] | Restricted Stock Units (RSUs) [Member] | Director [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares issued of common stock |
|
|
$ 57,517
|
|
|
Number of shares issued for services |
|
|
23,016
|
|
|
Common Stock [Member] | Restricted Stock Units (RSUs) [Member] | Andrew R. Boll [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares issued of common stock |
|
|
$ 26,520
|
|
|
Shares withheld for tax withholding obligation, shares |
|
|
18,480
|
|
|
Payroll tax obligations, value |
|
|
$ 197,000
|
|
|
Common Stock [Member] | Restricted Stock Units (RSUs) [Member] | Mark L. Baum [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Shares withheld for tax withholding obligation, shares |
|
|
59,836
|
|
|
Payroll tax obligations, value |
|
|
$ 638,000
|
|
|
Common Stock [Member] | Restricted Stock Units (RSUs) [Member] | John Saharek [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Number of shares issued of common stock |
|
|
$ 17,384
|
|
|
Shares withheld for tax withholding obligation, shares |
|
|
12,616
|
|
|
Payroll tax obligations, value |
|
|
$ 135,000
|
|
|
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2024 |
Forecast [Member] |
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
Payment of minimum annual order amounts |
|
|
|
|
$ 2,728,000
|
Asset Purchase, License and Related Agreements [Member] |
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
Royalty expenses |
$ 1,036,000
|
$ 0
|
$ 1,310,000
|
$ 0
|
|
Upfront and milestone payments |
0
|
0
|
0
|
5,000,000
|
|
Asset Purchase and License Agreements [Member] |
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
Royalty expenses |
$ 316,000
|
275,000
|
$ 496,000
|
651,000
|
|
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|
|
|
|
|
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|
|
|
|
|
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|
|
|
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|
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|
|
$ 130,000
|
|
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|
|
|
|
|
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|
|
|
|
|
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|
|
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|
|
|
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|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
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|
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|
|
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v3.24.2.u1
SEGMENTS AND CONCENTRATIONS (Details Narrative) - Segment
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Revenue, Major Customer [Line Items] |
|
|
|
|
|
Number of reportable segments |
|
|
1
|
|
|
Number of operating segments |
|
|
1
|
|
|
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Single Customer [Member] |
|
|
|
|
|
Revenue, Major Customer [Line Items] |
|
|
|
|
|
Concentration risk percentage |
45.00%
|
27.00%
|
40.00%
|
16.00%
|
|
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Single Customer [Member] |
|
|
|
|
|
Revenue, Major Customer [Line Items] |
|
|
|
|
|
Concentration risk percentage |
|
|
67.00%
|
|
80.00%
|
Purchases [Member] | Supplier Concentration Risk [Member] | Three Suppliers [Member] |
|
|
|
|
|
Revenue, Major Customer [Line Items] |
|
|
|
|
|
Concentration risk percentage |
61.00%
|
80.00%
|
62.00%
|
85.00%
|
|
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|
|
|
|
|
Revenue, Major Customer [Line Items] |
|
|
|
|
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Concentration risk percentage |
10.00%
|
10.00%
|
10.00%
|
10.00%
|
|
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|
|
|
|
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|
|
|
|
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Concentration risk percentage |
|
10.00%
|
|
|
|
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|
|
|
|
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|
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|
|
|
10.00%
|
|
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|
|
|
|
|
Revenue, Major Customer [Line Items] |
|
|
|
|
|
Concentration risk percentage |
23.00%
|
48.00%
|
14.00%
|
38.00%
|
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v3.24.2.u1
SUBSEQUENT EVENTS (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
Jul. 31, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Subsequent Event [Line Items] |
|
|
|
|
Proceeds from exercise of options |
|
|
$ 521,000
|
$ 337,000
|
Common Stock [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Number of shares issued |
|
10,000
|
700
|
10,000
|
Proceeds from exercise of options |
|
|
$ 521,000
|
|
Exercise price per share |
|
|
$ 7.60
|
|
Subsequent Event [Member] | Common Stock [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Number of shares issued |
2,563
|
|
|
|
Proceeds from exercise of options |
$ 53,000
|
|
|
|
Options to purchase common shares |
2,563
|
|
|
|
Subsequent Event [Member] | Common Stock [Member] | Minimum [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Exercise price per share |
$ 7.60
|
|
|
|
Subsequent Event [Member] | Common Stock [Member] | Maximum [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Exercise price per share |
$ 20.97
|
|
|
|
Subsequent Event [Member] | Common Stock One [Member] |
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
Number of shares issued |
889
|
|
|
|
Options to purchase common shares |
1,000
|
|
|
|
Exercise price per share |
$ 2.60
|
|
|
|
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