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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

 

        Page
Part I   FINANCIAL INFORMATION   3
         
Item 1.   Financial Statements   3
         
Item 2.   Management’s Discussion and Analysis of Financial Condition and Results of Operations   24
         
Item 3.   Quantitative and Qualitative Disclosures About Market Risk   30
         
Item 4.   Controls and Procedures   30
         
Part II   OTHER INFORMATION   31
         
Item 1.   Legal Proceedings   31
         
Item 1A.   Risk Factors   31
         
Item 2.   Unregistered Sales of Equity Securities and Use of Proceeds   31
         
Item 3.   Defaults Upon Senior Securities   31
         
Item 4.   Mine Safety Disclosures   31
         
Item 5.   Other Information   31
         
Item 6.   Exhibits   31
         
    Signatures   32

 

2
 

 

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

 

3
 

 

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)
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 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

 

4
 

 

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 
                                    
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 

 

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 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 
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

 

6
 

 


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.

 

7
 

 

To determine the provision for credit losses for accounts receivable, the Company has disaggregated its accounts receivable by class of customer at the business component level, as management determined that risk profile of the Company’s customers is consistent based on the type and industry in which they operate, mainly in the pharmaceuticals industry. Each business component is analyzed for estimated credit losses individually. In doing so, the Company establishes a historical loss matrix, based on the previous collections of accounts receivable by the age of such receivables, and evaluates the current and forecasted financial position of its customers, as available. Further, the Company considers macroeconomic factors and the status of the pharmaceuticals industry to estimate if there are current expected credit losses within its trade receivables based on the trends of the Company’s expectation of the future status of such economic and industry-specific factors. Also, specific allowance amounts are established based on review of outstanding invoices to record the appropriate provision for customers that have a higher probability of default.

 

The accounts receivable balance on the Company’s condensed consolidated balance sheet as of June 30, 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:

 

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.

 

8
 

 

The following table presents the estimated fair values and the carrying values:

 

   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:

 

   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.

 

9
 

 

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:

 

   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.

 

10
 

 

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.

 

11
 

 

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:

  

   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.

 

12
 

 

In March 2024, Melt completed its Series B Preferred Stock financing which raised gross proceeds of approximately $23,900,000.

 

The Company’s Chief Executive Officer, Mark L. Baum, is a member of the Melt board of directors. The Melt board of directors consists of five members, including Mr. Baum. Mr. Baum is the only representative of the Company on Melt’s board of directors.

 

The unaudited condensed results of operations information of Melt is summarized below:

 

   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:

 

   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:

 

  

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:

 

  

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 

 

13
 

 

NOTE 7. PROPERTY, PLANT AND EQUIPMENT

 

Property, plant and equipment consisted of the following:

 

  

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:

 

  

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:

 

  

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 

 

14
 

 

Amortization expense for intangible assets was as follows:

 

   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:

 

      
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:

 

   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.

 

15
 

 

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:

 

   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:

 

   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 

 

16
 

 

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 seven year 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:

 

   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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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.

 

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Stock Options

 

A summary of stock option activity under the Plans for the six months ended June 30, 2024 is as follows:

 

   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:

 

   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   - 

 

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The following table summarizes information about stock options outstanding and exercisable at June 30, 2024:

 

   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:

 

   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:

 

   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 

 

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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:

 

   2024   2023   2024   2023 
   For the Three Months Ended
June 30,