Item 1. Financial Statements
Item
1. Financial Statements
HARROW,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
March
31,
December
31,
2024
2023
(Unaudited)
ASSETS
Current
assets
Cash
and cash equivalents
$ 68,538,000
$ 74,085,000
Investment
in Eton Pharmaceuticals
7,433,000
8,681,000
Accounts
receivable, net
28,960,000
37,271,000
Inventories
10,810,000
10,867,000
Prepaid
expenses and other current assets
9,717,000
9,588,000
Total
current assets
125,458,000
140,492,000
Property,
plant and equipment, net
3,389,000
3,521,000
Capitalized
software costs, net
2,019,000
2,138,000
Operating
lease right-of-use assets, net
6,968,000
6,785,000
Intangible
assets, net
157,370,000
159,906,000
Goodwill
332,000
332,000
TOTAL
ASSETS
$ 295,536,000
$ 313,174,000
LIABILITIES
AND STOCKHOLDERS’ EQUITY
Current
liabilities
Accounts
payable and accrued expenses
$ 15,129,000
$ 24,581,000
Accrued
rebates and copay assistance
20,690,000
19,442,000
Accrued
payroll and related liabilities
5,027,000
5,450,000
Deferred
revenue and customer deposits
112,000
75,000
Current
portion of operating lease obligations
795,000
806,000
Total
current liabilities
41,753,000
50,354,000
Operating
lease obligations, net of current portion
6,716,000
6,524,000
Accrued
expenses, net of current portion
2,713,000
2,713,000
Notes
payable, net of unamortized debt discount
184,148,000
183,172,000
TOTAL
LIABILITIES
235,330,000
242,763,000
Commitments
and contingencies
-
-
STOCKHOLDERS’
EQUITY
Common
stock, $ 0.001 par value, 50,000,000 shares authorized, 35,380,955 and 35,168,260 shares issued and outstanding at March 31, 2024
and December 31, 2023, respectively
35,000
35,000
Additional
paid-in capital
207,995,000
204,635,000
Accumulated
deficit
( 147,469,000 )
( 133,904,000 )
TOTAL
HARROW, INC. STOCKHOLDERS’ EQUITY
60,561,000
70,766,000
Noncontrolling
interests
( 355,000 )
( 355,000 )
TOTAL
STOCKHOLDERS’ EQUITY
60,206,000
70,411,000
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 295,536,000
$ 313,174,000
The
accompanying notes are an integral part of these condensed consolidated financial statements
3
HARROW, INC.
UNAUDITED CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
2024
2023
For the Three Months Ended
March 31,
2024
2023
Revenues:
Product sales, net
$ 34,508,000
$ 20,453,000
Other revenues
79,000
5,650,000
Total revenues
34,587,000
26,103,000
Cost of sales
( 10,553,000 )
( 8,271,000 )
Gross profit
24,034,000
17,832,000
Operating expenses:
Selling, general and administrative
28,813,000
15,888,000
Research and development
2,149,000
734,000
Total operating expenses
30,962,000
16,622,000
(Loss)income from operations
( 6,928,000 )
1,210,000
Other (expense) income:
Interest expense, net
( 5,415,000 )
( 4,747,000 )
Investment (loss) gain from Eton Pharmaceuticals
( 1,248,000 )
2,042,000
Loss on extinguishment of debt
-
( 5,465,000 )
Other income, net
26,000
29,000
Total other expense, net
( 6,637,000 )
( 8,141,000 )
Loss before income tax expense
( 13,565,000 )
( 6,931,000 )
Income tax benefit
-
288,000
Net loss
( 13,565,000 )
( 6,643,000 )
Basic and diluted net loss per share of common stock
$ ( 0.38 )
$ ( 0.22 )
Weighted average number of shares of common stock outstanding, basic and
diluted
35,469,638
30,289,730
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
4
HARROW, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
For the Three Months Ended March 31, 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 employee stock-based options
97,542
-
148,000
-
148,000
-
148,000
Vesting of RSUs
111,000
-
-
-
-
-
-
Shares withheld related to net share settlement of equity awards
( 53,702 )
-
( 850,000 )
-
( 850,000 )
-
( 850,000 )
Stock-based compensation expense
-
-
1,633,000
-
1,633,000
-
1,633,000
Net loss
-
-
-
( 6,643,000 )
( 6,643,000 )
-
( 6,643,000 )
Balance at March 31, 2023
30,056,370
$ 30,000
$ 137,989,000
$ ( 116,136,000 )
$ 21,883,000
$ ( 355,000 )
$ 21,528,000
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, 2023
35,168,260
$ 35,000
$ 204,635,000
$ ( 133,904,000 )
$ 70,766,000
$ ( 355,000 )
$ 70,411,000
Balance
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
46,175
-
348,000
-
348,000
-
348,000
Vesting of RSUs
275,000
-
-
-
-
-
-
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
-
-
4,169,000
-
4,169,000
-
4,169,000
Net loss
-
-
-
( 13,565,000 )
( 13,565,000 )
-
( 13,565,000 )
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
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
5
HARROW,
INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Three Months Ended
March 31,
2024
2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$ ( 13,565,000 )
$ ( 6,643,000 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization of property, plant and equipment and software development costs
432,000
292,000
Amortization of intangible assets
2,554,000
2,207,000
Amortization of operating lease right-of-use assets
194,000
177,000
(Recovery of) provision for credit losses
( 85,000 )
20,000
Amortization of debt issuance costs and debt discount
976,000
761,000
Investment loss (gain) from investment in Eton
1,248,000
( 2,042,000 )
Loss on extinguishment of debt
-
5,465,000
Stock-based compensation
4,169,000
1,633,000
Deferred income tax
-
( 288,000 )
Changes in assets and liabilities:
Accounts receivable
8,396,000
( 5,882,000 )
Inventories
57,000
( 2,552,000 )
Prepaid expenses and other current assets
321,000
7,000
Accounts payable, accrued expenses, accrued rebates and copay assistance
( 8,939,000 )
( 212,000 )
Accrued payroll and related liabilities
( 423,000 )
( 1,111,000 )
Deferred revenue and customer deposits
37,000
( 46,000 )
NET CASH USED IN OPERATING ACTIVITIES
( 4,628,000 )
( 8,214,000 )
CASH FLOWS FROM INVESTING ACTIVITIES
Investment in patent and trademark assets
( 18,000 )
-
Purchase of product NDAs and related patents
-
( 130,474,000 )
Purchases of property, plant and equipment
( 92,000 )
( 496,000 )
NET CASH USED IN INVESTING ACTIVITIES
( 110,000 )
( 130,970,000 )
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 payroll taxes upon vesting of PSUs, RSUs and exercise of stock options
( 1,157,000 )
( 661,000 )
Proceeds from exercise of stock options
348,000
148,000
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
( 809,000 )
62,162,000
NET CHANGE IN CASH AND CASH EQUIVALENTS
( 5,547,000 )
( 77,022,000 )
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
74,085,000
96,270,000
CASH AND CASH EQUIVALENTS AT END OF PERIOD
$ 68,538,000
$ 19,248,000
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for income taxes
$ -
$ -
Cash paid for interest
$ 5,340,000
$ 3,371,000
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
$ 89,000
$ 61,000
Right-of-use assets obtained in exchange for new operating lease obligations
$ 377,000
$ -
Income taxes owed for exercise of options
$ -
$ 189,000
Insurance premium financed
$ 450,000
$ -
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
6
HARROW,
INC.
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
the Three Months Ended March 31, 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. that are marketed under
its Harrow name. The Company also owns and operates ImprimisRx, one of the nation’s leading ophthalmology-focused pharmaceutical-compounding
businesses.
The
Company owns non-controlling equity interests in Surface Ophthalmics, Inc. (“Surface”) and Melt Pharmaceuticals, Inc. (“Melt”),
both companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in various drug candidates being developed by Surface
and Melt.
Basis
of Presentation
The
Company has prepared the accompanying unaudited condensed consolidated financial statements in accordance with accounting principles
generally accepted in the United States of America (“GAAP”) for interim financial information and in accordance with the
rules and regulations of the U.S. Securities and Exchange Commission. Accordingly, they do not include all of the information and footnotes
required by GAAP for audited financial statements. In the opinion of management, all adjustments (consisting of only normal recurring
adjustments) considered necessary for a fair presentation have been included. Operating results for the three months ended March 31,
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 months ended March 31, 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.
7
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
March 31, 2024 and December 31, 2023, the Company measured its investment in Eton Pharmaceuticals, Inc. (“Eton”) on a recurring
basis. The Company’s investment in Eton is classified as Level 1 as the fair value is determined using quoted market prices in
active markets for the same securities. As of March 31, 2024 and December 31, 2023, the fair market value of the Company’s investment
in Eton was $ 7,433,000 and $ 8,681,000 , respectively. The Company sold its remaining interest in April 2024 (see Note 16).
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
March 31, 2024
December 31, 2023
Carrying Value
Fair Value
Carrying Value
Fair Value
2026 Notes
$ 73,413,000
$ 73,560,000
$ 73,218,000
$ 70,260,000
2027 Notes
$ 37,591,000
$ 41,860,000
$ 37,413,000
$ 40,363,000
Oaktree Loan
$ 73,144,000
$ 76,725,000
$ 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”), performance stock units (“PSUs”), and warrants, outstanding during the period. Common equivalent
shares (using the treasury stock method) from stock options, unvested RSUs, unvested PSUs and warrants were 4,318,057 and 4,750,340 at
March 31, 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 resigns. The number of shares underlying
vested RSUs at March 31, 2024 and 2023 was 223,928 and 336,264 , respectively.
8
The
following table shows the computation of basic net loss per share of common stock for the three months ended March 31, 2024 and 2023:
SCHEDULE
OF BASIC NET LOSS PER SHARE OF COMMON STOCK
2024
2023
For the Three Months Ended
March 31,
2024
2023
Numerator – net loss
$ ( 13,565,000 )
$ ( 6,643,000 )
Denominator – weighted average number of shares outstanding, basic and diluted
35,469,638
30,289,730
Net loss per share, basic and diluted
$ ( 0.38 )
$ ( 0.22 )
Income
Taxes
The
Company’s effective tax rate was ( 0.11 )% and 4.16 % for the three months ended March 31, 2024 and 2023, respectively. The Company’s
effective tax rate for the three months ended March 31, 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 March 31, 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 March 31, 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 and
uses the equity method of accounting for this investment. Under this method, the Company recognizes its portion of 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 other 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 March 31, 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.
9
Accounting
Guidance Issued but Not Adopted at March 31, 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.
Reclassifications
Certain
prior period items and amounts have been reclassified to conform to the classifications used to prepare the condensed consolidated financial
statements for the current period. These reclassifications had no material impact on the Company’s condensed consolidated financial
position, results of operations, or cash flows as previously reported.
NOTE
3. REVENUES
The
Company accounts for contracts with customers in accordance with ASC 606, Revenues from Contracts with Customers . The Company
has three primary streams of revenue: (1) 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 in 2023, 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.
10
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 March 31, 2024, the Company holds 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.
11
Revenue
disaggregated by revenue source for the three months ended March 31, 2024 and 2023 consisted of the following:
SCHEDULE OF DISAGGREGATED REVENUE
2024
2023
For the Three Months Ended
March 31,
2024
2023
Product sales, net
$ 34,508,000
$ 20,453,000
Other revenues (including transfer of acquired product sales/profit)
79,000
5,650,000
Total revenues
$ 34,587,000
$ 26,103,000
Deferred
revenue and customer deposits at March 31, 2024 and December 31, 2023 were $ 112,000 and $ 75,000 , respectively. All deferred revenue and
customer deposit amounts at December 31, 2023 were recognized as revenue during the three months ended March 31, 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 months
ended March 31, 2024 and 2023, the Company recorded $ 0 and $ 59,000 , respectively, due from Melt for reimbursable expenses and amounts
payable pursuant to the Melt MSA, which are included in prepaid expenses and other current assets in the accompanying condensed consolidated
balance sheets. As of March 31, 2024 and December 31, 2023, the Company was due $ 228,000 , from
Melt for reimbursable expenses and amounts due 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, was previously a member of the Melt board of directors until his resignation during
the year ended December 31, 2021. Mr. Baum re-joined the Melt board of directors in January 2023. At the time Mr. Baum re-joined, the
Melt board of directors consisted of five members, including Mr. Baum, who is the only representative of the Company on Melt’s
board of directors.
The
unaudited condensed results of operations information of Melt is summarized below:
SCHEDULE
OF CONDENSED INCOME STATEMENT
2024
2023
For
the Three Months Ended
March
31,
2024
2023
Revenues,
net
$
-
$
-
Loss
from operations
$
( 2,036,000
)
$
( 1,352,000
)
Net
loss
$
( 1,893,000
)
$
( 1,858,000
)
12
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE
OF CONDENSED BALANCE SHEET
2024
2023
At March 31,
At December 31,
2024
2023
Current assets
$ 14,277,000
$ 13,404,000
Non-current assets
-
-
Total assets
$ 14,277,000
$ 13,404,000
Total liabilities
$ 3,524,000
$ 3,922,000
Total preferred stock and stockholders’ equity
10,753,000
9,482,000
Total liabilities and stockholders’ equity
$ 14,277,000
$ 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 as of March 31, 2024
and December 31, 2023 was as follows:
SCHEDULE
OF INVENTORIES
March 31, 2024
December 31, 2023
Raw materials
$ 5,470,000
$ 5,477,000
Work in progress
140,000
54,000
Finished goods
5,200,000
5,336,000
Total inventories
$ 10,810,000
$ 10,867,000
NOTE
6. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets at March 31, 2024 and December 31, 2023 consisted of the following:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
March 31, 2024
December 31, 2023
Prepaid insurance
$ 766,000
$ 1,241,000
Prepaid computer software licenses and related expenses
1,462,000
1,613,000
Other prepaid expenses
2,350,000
906,000
Receivable due from Melt
228,000
228,000
Prepaid FY 2024 Prescription Drug User (“PDUFA”) fees
2,292,000
3,438,000
Deferred Oaktree Loan commitment fee
468,000
409,000
Deposits and other current assets
2,151,000
1,753,000
Total prepaid expenses and other current assets
$ 9,717,000
$ 9,588,000
NOTE
7. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment at March 31, 2024 and December 31, 2023 consisted of the following:
SCHEDULE
OF PROPERTY, PLANT AND EQUIPMENT
March
31, 2024
December
31, 2023
Property,
plant and equipment, net:
Computer
hardware
$
1,323,000
$
1,322,000
Furniture
and equipment
942,000
936,000
Lab
and pharmacy equipment
4,690,000
4,564,000
Leasehold
improvements
6,802,000
6,771,000
Property,
plant and equipment, gross
13,757,000
13,593,000
Accumulated
depreciation
( 10,368,000
)
( 10,072,000 )
Property,
plant and equipment, net
$
3,389,000
$
3,521,000
For
the three months ended March 31, 2024 and 2023, depreciation related to the property, plant and equipment was $ 296,000 and $ 225,000 ,
respectively.
13
NOTE
8. CAPITALIZED SOFTWARE COSTS
Capitalized
software costs at March 31, 2024 and December 31, 2023 consisted of the following:
SCHEDULE OF CAPITALIZED SOFTWARE COSTS
March 31, 2024
December 31, 2023
Capitalized software costs
Capitalized internal-use software development costs
$ 2,780,000
$ 2,780,000
Acquired third-party software license for internal-use
159,000
159,000
Total gross capitalized software for internal-use
2,939,000
2,939,000
Accumulated amortization
( 1,404,000 )
( 1,268,000 )
Capitalized internal-use software in process
484,000
467,000
Total capitalized software costs net
$ 2,019,000
$ 2,138,000
For
the three months ended March 31, 2024 and 2023, the Company recorded amortization expense related to capitalized software costs of $ 136,000
and $ 67,000 , respectively.
NOTE
9. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at March 31, 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
$ ( 169,000 )
$ -
$ 441,000
Licenses
7 - 20
50,000
( 2,000 )
-
48,000
Trademarks
Indefinite
217,000
-
-
217,000
Acquired new drug applications (“NDAs”)
4 - 15
170,353,000
( 13,830,000 )
-
156,523,000
Customer relationships
3 - 15
596,000
( 526,000 )
-
70,000
Trade name
5
75,000
( 5,000 )
-
70,000
Non-competition clause
3 - 4
50,000
( 50,000 )
-
-
State pharmacy licenses
25
8,000
( 7,000 )
-
1,000
$ 171,959,000
$ ( 14,589,000 )
$ -
$ 157,370,000
Amortization
expense for intangible assets for the three months ended March 31, 2024 and 2023 was as follows:
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
2024
2023
For the Three Months Ended
March 31,
2024
2023
Patents
$ 14,000
$ 22,000
Licenses
-
2,000
Acquired NDAs
2,530,000
2,170,000
Customer relationships
10,000
13,000
Amortization of intangible
assets
$ 2,554,000
$ 2,207,000
Estimated
future amortization expense for the Company’s intangible assets at March 31, 2024 was as follows:
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE
Remainder
of 2024
$
10,240,000
2025
13,658,000
2026
13,658,000
2027
13,309,000
2028
12,961,000
Thereafter
93,327,000
Intangible assets
$
157,153,000
There
were no changes to the carrying value of the Company’s goodwill during the three months ended March 31, 2024 and 2023.
14
NOTE
10. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses at March 31, 2024 and December 31, 2023 consisted of the following:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
March
31,
December
31,
2024
2023
Accounts
payable
$
12,567,000
$
21,424,000
Accrued
insurance premium
450,000
873,000
Other
accrued payments
106,000
306,000
Accrued
interest (see Note 11)
2,006,000
1,978,000
Accrued
exit fee for Oaktree Loan (see Note 11)
2,713,000
2,713,000
Total
accounts payable and accrued expenses
$
17,842,000
$
27,294,000
Less:
current portion
( 15,129,000
)
( 24,581,000 )
Non-current
total accrued expenses
$
2,713,000
$
2,713,000
The
Company financed all insurance policies for the policy term of August 2023 through August 2024. The financing agreement has an interest
rate of 7.48 % per annum and requires nine monthly payments of $ 150,000 , of which we have three payments remaining as of March 31, 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 $ 2,953,000 and $ 95,000 for the three months ended March 31, 2024 and 2023, respectively,
and included the amortization of debt issuance costs and discount of $ 603,000 and $ 12,000 , respectively.
HROWM
– 11.875% Senior Notes Due 2027
In
December 2022 and in 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 $ 1,395,000 for the three months ended March 31, 2024 and 2023, respectively, and included the amortization of debt issuance
costs and discount of $ 178,000 and $ 200,000 , respectively.
HROWL
– 8.625% Senior Notes Due 2026
In
April and September 2021, the Company closed offerings (including an over-allotment exercise in May 2021) of $ 75,000,000 aggregate principal
amount of 8.625 % senior notes due April 2026 (the “2026 Notes”). In terest expense related
to the 2026 Notes totaled $ 1,812,000 and $ 1,810,000 for the three months ended March 31, 2024 and 2023, respectively, and included amortization
of debt issuance costs and debt discount of $ 195,000 and $ 193,000 , respectively.
15
A
summary of the Company’s debt at March 31, 2024 and December 31, 2023 is described as follows:
SCHEDULE OF LONG TERM DEBT
March
31,
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
( 8,602,000
)
( 9,578,000
)
Notes payable net
$
184,148,000
$
183,172,000
For
the three months ended March 31, 2024 and 2023, the total effective interest rate of the Company’s debt was 10.78 % .
At
March 31, 2024, future minimum payments under the Company’s debt were as follows:
SCHEDULE OF FUTURE MINIMUM PAYMENT UNDER NOTES PAYABLES
Amount
Remainder of 2024
$ 15,902,000
2025
20,614,000
2026
159,897,000
2027
45,030,000
Total minimum payments
243,443,000
Less: amount representing interest payments
( 48,693,000 )
Notes payable, gross principal amount due
192,750,000
Less: unamortized debt issuance costs, net of premium
( 8,602,000 )
Notes payable, net of unamortized debt issuance costs
$ 184,148,000
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, we entered in a new operating lease for 17,625 square feet of office space in Nashville, Tennessee which is expected
to commence in July 2024 and has a seven year term (target expiration date of June 30, 2032 ) with an option to extend the term for
two additional five-year terms. 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
March 31, 2024, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases
held by the Company were 6.61 % and 11.26 years, respectively.
During
the three months ended March 31, 2024 and 2023, cash paid for amounts included for the operating lease liabilities was $ 327,000 and $ 306,000 ,
respectively. During the three months ended March 31, 2024 and 2023, the Company recorded operating lease expense of $ 319,000 and $ 309,000 ,
respectively, which is included in selling, general and administrative expenses.
16
Future
lease payments under operating leases as of March 31, 2024 were as follows :
SCHEDULE OF FUTURE LEASE PAYMENTS UNDER OPERATING LEASES
Operating Leases
Remainder of 2024
$ 978,000
2025
1,133,000
2026
1,155,000
2027
1,014,000
2028
699,000
Thereafter
5,533,000
Total minimum lease payments
10,512,000
Less: amount representing interest payments
( 3,001,000 )
Total operating lease obligations
7,511,000
Less: current portion, operating lease obligations
( 795,000 )
Operating lease obligations, net of current portion
$ 6,716,000
NOTE
13. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Common
Stock
During
the three months ended March 31, 2024, the Company issued 46,175 shares of common stock and received proceeds of $ 348,000 upon the exercise
of options to purchase 46,175 shares of common stock with exercise prices ranging from $ 6.75 to $ 8.75 per share.
During
the three months ended March 31, 2024, 45,000 RSUs granted in February 2021 to Andrew R. Boll, the Company’s Chief Financial Officer,
vested, and 26,520 shares 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 three months ended March 31, 2024, 150,000 RSUs granted in February 2021 to Mark L. Baum, the Company’s Chief Executive Officer,
vested, and 90,164 shares 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 three months ended March 31, 2024, 30,000 RSUs granted in February 2021 to John Saharek, the Company’s Chief Commercial Officer,
vested, and 17,384 shares 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 three months ended March 31, 2024, 50,000 RSUs granted in February 2021 to employees, vested, and 32,452 shares 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 three months ended March 31, 2024, 8,389 shares of the Company’s common stock underlying RSUs issued to directors vested, but
the issuance and delivery of these shares are deferred until the applicable director ceases 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 December 31, 2023, the 2017 Plan provides for the issuance of a maximum of 6,000,000
shares of the Company’s common stock. The purpose of the Plans are to attract and retain directors, officers, consultants, advisors
and employees whose services are considered valuable, to encourage a sense of proprietorship and to stimulate an active interest of such
persons in the Company’s development and financial success. Under the Plans, the Company is authorized to issue incentive stock
options intended to qualify under Section 422 of the Internal Revenue Code of 1986, as amended, non-qualified stock options, restricted
stock units and restricted stock. The Plans are administered by the Compensation Committee of the Company’s Board of Directors.
The Company had 400,250 shares available for future issuances under the 2017 Plan at March 31, 2024.
17
Stock
Options
A
summary of stock option activity under the Plans for the three months ended March 31, 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
51,500
$ 9.81
Options exercised
( 46,175 )
$ 7.54
Options cancelled/forfeited
( 48,626 )
$ 12.22
Options outstanding – March 31, 2024
2,668,016
$ 6.19
3.82
$ 19,285,000
Options exercisable
2,404,897
$ 5.55
3.27
$ 18,508,000
Options vested and expected to vest
2,631,881
$ 6.10
3.75
$ 19,191,000
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 March 31, 2024, based on the closing price of the Company’s common stock of $ 13.23 on that
date.
During
the three months ended March 31, 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 three months ended March 31, 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
$ 6.34
Expected terms (in years)
6.11
Expected volatility
68 %
Risk-free interest rate
4.06 - 4.21 %
Dividend yield
-
18
The
following table summarizes information about stock options outstanding and exercisable at March 31, 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
295,852
3.71
$ 1.72
295,852
$ 1.72
$ 2.23
285,000
2.84
$ 2.23
285,000
$ 2.23
$ 2.40 - $ 2.60
24,068
2.77
$ 2.58
24,068
$ 2.58
$ 3.95
310,000
2.00
$ 3.95
310,000
$ 3.95
$ 4.49 - $ 5.72
100,225
5.22
$ 5.54
96,350
$ 5.53
$ 6.30
285,000
4.89
$ 6.30
285,000
$ 6.30
$ 6.75 - $ 7.26
62,500
8.24
$ 6.91
24,979
$ 6.92
$ 7.30
274,500
5.76
$ 7.30
274,500
$ 7.30
$ 7.37 - $ 7.79
204,261
4.14
$ 7.50
155,136
$ 7.47
$ 7.87 - $ 25.86
826,610
3.30
$ 9.38
654,012
$ 8.01
$ 1.47 - $ 25.86
2,668,016
3.82
$ 6.19
2,404,897
$ 5.55
As
of March 31, 2024, there was approximately $ 1,815,000 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 2.81 years. The stock-based
compensation for all stock options was $ 126,000 and $ 341,000 during the three months ended March 31, 2024 and 2023, respectively.
The
intrinsic value of options exercised during the three months ended March 31, 2024 was $ 139,000 .
Restricted
Stock Units
RSU
awards are granted subject to certain vesting requirements and other restrictions, including time-based performance and market-based
vesting criteria. The grant date fair value of the RSUs, which has been determined based upon the market value of the Company’s
common stock on the grant date, is expensed over the vesting period of the RSUs.
A
summary of the Company’s RSU activity and related information for the three months ended March 31, 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
6,238
9.66
RSUs vested
( 283,389 )
9.21
RSUs cancelled/forfeited
( 3,750 )
8.10
RSUs unvested - March 31, 2024
82,128
$ 9.37
As
of March 31, 2024, the total unrecognized compensation expense related to unvested RSUs was approximately $ 859,000 , 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 months ended March 31, 2024 and 2023 was $ 405,000 and $ 29,000 , respectively.
19
Performance
Stock Units
A
summary of the Company’s PSU activity and related information for the three months ended March 31, 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 – March 31, 2024
1,567,913
$ 18.56
As
of March 31, 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 1.01 years, based on estimated and actual vesting schedules of the applicable PSUs.
The stock-based compensation for PSUs during the three months ended March 31, 2024 and 2023 was $ 3,638,000 and $ 1,263,000 , 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
For the Three Months Ended March 31,
2024
2023
Employees - selling, general and administrative
$ 3,525,000
$ 1,328,000
Employees – research and development
439,000
163,000
Directors - selling, general and administrative
188,000
125,000
Consultants - selling, general and administrative
17,000
17,000
Total
$ 4,169,000
$ 1,633,000
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 footnote.
The
Company records accruals for loss contingencies to the extent that it concludes it is probable that a liability has been incurred and
the amount of the related loss can be reasonably estimated. The Company evaluates, on a quarterly basis, developments in legal proceedings
and other matters that could cause an increase or decrease in the amount of a liability that has been accrued previously.
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 footnote or not) currently pending may have a material adverse effect on the Company’s condensed consolidated
results of operations, financial position or cash flows.
Ocular
Science, Inc. et. al
In
July 2021, ImprimisRx, LLC, a subsidiary of the Company, filed a lawsuit against Ocular Science, Inc. and OSRX, Inc. (together, “OSRX”)
in the U.S. District Court for the Southern District of California, asserting claims for copyright infringement, trademark infringement,
unfair competition and false advertising (Lanham Act). ImprimisRx is seeking damages from OSRX. Since July 2021, the complaint has been
amended and OSRX added counterclaims alleging ImprimisRx, LLC is violating the Lanham Act with false advertising. Both parties are seeking
damages from the other. The Company expects the trial to take place in August 2024.
20
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
months ended March 31, 2024 and 2023, $ 274,000 and $ 0 were incurred under these agreements as royalty expenses, respectively. The
Company incurred $ 0 and $ 5,000,000 related to upfront and milestone payments under these agreements during the three months ended March 31,
2024 and 2023, respectively. As of March 31, 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 months ended March 31, 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 months ended March 31, 2024 and 2023, $ 180,000 and $ 376,000 were incurred under
these agreements as royalty expenses, respectively.
21
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 months ended March 31, 2024 and 2023, respectively.
Contract
Manufacturing
The
Company had 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. The Company’s chief operating decision-maker is the Chief Executive Officer, who evaluates
the Company as a single operating segment.
The
Company had one and two products that accounted for more than 10% of total revenues during the three months ended March 31, 2024 and
2023, respectively. These products accounted for 11 % and 36 % of revenues during the three months ended March 31, 2024 and 2023, respectively.
As
of March 31, 2024 and December 31, 2023, accounts receivable from a single customer accounted for 68 % and 80 % of total accounts receivable,
respectively. For the three months ended March 31, 2024, revenues from a single customer accounted for 27 % of total revenues. For the
three months ended March 31, 2023, no customer exceeded 10% of total revenues.
The
Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 85 % of active
pharmaceutical ingredient purchases during the three months ended March 31, 2024, and 90 % during the same period in 2023.
NOTE
16. SUBSEQUENT EVENTS
The
Company has performed an evaluation of events occurring subsequent to March 31, 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
April 2024, the Company issued 1,481 shares of common stock and received proceeds of $ 11,000 upon the exercise of options to purchase
1,481 shares of common stock with exercise prices between $ 10.62 and $ 12.72 per share.
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 related to
the trade.
22
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.