Item 1. Financial Statements
Item
1. Financial Statements
HARROW
HEALTH, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
March 31,
December 31,
2022
2021
(unaudited)
ASSETS
Current assets
Cash and cash equivalents
$ 41,948,000
$ 42,167,000
Investment in Eton Pharmaceuticals
8,642,000
8,503,000
Accounts receivable, net
5,995,000
4,470,000
Inventories
4,396,000
4,217,000
Prepaid expenses and other current assets
1,334,000
1,305,000
Total current assets
62,315,000
60,662,000
Property, plant and equipment, net
2,968,000
3,141,000
Capitalized software costs, net
1,471,000
1,313,000
Operating lease right-of-use assets
6,847,000
5,935,000
Intangible assets, net
15,415,000
15,813,000
Investment in Melt Pharmaceuticals
8,247,000
11,133,000
Goodwill
332,000
332,000
TOTAL ASSETS
$ 97,595,000
$ 98,329,000
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable and accrued expenses
$ 6,758,000
$ 6,337,000
Accrued payroll and related liabilities
1,948,000
3,089,000
Deferred revenue and customer deposits
23,000
16,000
Current portion of operating lease obligations
445,000
272,000
Current portion of finance lease obligations
8,000
8,000
Total current liabilities
9,182,000
9,722,000
Operating lease obligations, net of current portion
6,823,000
6,012,000
Finance lease obligations, net of current portion
7,000
10,000
Loans payable, net of current portion and unamortized debt discount
71,847,000
71,654,000
TOTAL LIABILITIES
87,859,000
87,398,000
Commitments and contingencies
-
STOCKHOLDERS’ EQUITY
Common stock, $ 0.001 par value, 50,000,000 shares authorized, 27,031,127 and 26,902,763 shares issued
and outstanding at March 31, 2022 and December 31, 2021, respectively
27,000
27,000
Additional paid-in capital
107,909,000
106,666,000
Accumulated deficit
( 97,845,000 )
( 95,407,000 )
TOTAL HARROW HEALTH STOCKHOLDERS’ EQUITY
10,091,000
11,286,000
Noncontrolling interests
( 355,000 )
( 355,000 )
TOTAL STOCKHOLDERS’ EQUITY
9,736,000
10,931,000
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 97,595,000
$ 98,329,000
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
3
HARROW
HEALTH, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the
Three Months Ended
March 31,
2022
2021
Revenues:
Product sales, net
$ 20,340,000
$ 14,948,000
Other revenues
1,780,000
495,000
Total revenues
22,120,000
15,443,000
Cost of sales
( 5,963,000 )
( 3,770,000 )
Gross profit
16,157,000
11,673,000
Operating expenses:
Selling, general and administrative
13,398,000
8,164,000
Research and development
658,000
592,000
Total operating expenses
14,056,000
8,756,000
Income from operations
2,101,000
2,917,000
Other (expense) income:
Interest expense, net
( 1,792,000 )
( 513,000 )
Equity in losses of unconsolidated entities
( 2,886,000 )
( 1,319,000 )
Investment gain (loss) from Eton Pharmaceuticals
139,000
( 2,835,000 )
Gain on forgiveness of PPP loan
-
1,967,000
Total other expense, net
( 4,539,000 )
( 2,700,000 )
(Loss) income before income taxes
( 2,438,000 )
217,000
Income taxes
-
-
Net (loss) income attributable to common stockholders
$ ( 2,438,000 )
$ 217,000
Basic net (loss) income per share of common stock
$ ( 0.09 )
$ 0.01
Diluted net (loss) income per share of common stock
$ ( 0.09 )
$ 0.01
Weighted average number of shares of common stock
outstanding, basic
27,226,819
26,019,255
Weighted average number of shares of common stock outstanding, diluted
27,226,819
27,480,622
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
4
HARROW
HEALTH, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
For
the Three Months Ended March 31, 2022 and 2021
Preferred
Stock
Common
Stock
Additional
Total
Harrow
Health, Inc.
Total
Non
controlling
Total
Par
Par
Paid-in
Accumulated
Stockholders’
Interest
Stockholders’
Shares
Value
Shares
Value
Capital
Deficit
Equity
Equity
Equity
Balance at December 31, 2020
-
$ -
25,749,875
$ 26,000
$ 104,557,000
$ ( 77,400,000 )
$ 27,183,000
$ ( 355,000 )
$ 26,828,000
Issuance of common stock in connection with:
Exercise of employee options
11,301
27,000
-
27,000
-
27,000
Vesting of RSUs
-
230,000
-
-
-
-
-
Shares withheld related to net share settlement of equity awards
-
-
( 7,500 )
-
( 57,000 )
-
( 57,000 )
-
( 57,000 )
Stock-based compensation expense
-
-
-
-
855,000
-
855,000
-
855,000
Net income
-
-
-
-
-
217,000
217,000
-
217,000
Balance at March 31, 2021
-
$ -
25,983,676
$ 26,000
$ 105,382,000
$ ( 77,183,000 )
$ 28,225,000
$ ( 355,000 )
$ 27,870,000
Balance at December 31, 2021
-
$ -
26,902,763
$ 27,000
$ 106,666,000
$ ( 95,407,000 )
$ 11,286,000
$ ( 355,000 )
$ 10,931,000
Issuance of common stock in connection with:
Exercise of employee options
-
-
89,986
-
4,000
-
4,000
-
4,000
Vesting of RSUs
-
-
135,000
1,000
( 1,000 )
-
-
-
-
Shares withheld related to net share settlement of equity awards
-
-
( 96,622 )
( 1,000 )
( 776,000 )
-
( 777,000 )
-
( 777,000 )
Stock-based compensation expense
-
-
-
-
2,016,000
-
2,016,000
-
2,016,000
Net loss
-
-
-
-
-
( 2,438,000 )
( 2,438,000 )
-
( 2,438,000 )
Balance at March 31, 2022
-
$ -
27,031,127
$ 27,000
$ 107,909,000
$ ( 97,845,000 )
$ 10,091,000
$ ( 355,000 )
$ 9,736,000
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
5
HARROW
HEALTH, INC.
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Three Months Ended
March 31,
2022
2021
CASH FLOWS FROM OPERATING ACTIVITIES
Net (loss) income
$ ( 2,438,000 )
$ 217,000
Adjustments to reconcile net (loss) income to net cash provided by operating
activities:
Depreciation and amortization
419,000
464,000
Amortization of intangible assets
404,000
40,000
Amortization of operating lease right-of-use assets
124,000
148,000
Provision for bad debt expense
10,000
19,000
Amortization of debt issuance costs and discount
193,000
96,000
Gain on forgiveness of PPP loan
-
( 1,967,000 )
Investment (gain) loss from investment in Eton
( 139,000 )
2,835,000
Equity in losses of unconsolidated entities
2,886,000
1,319,000
Stock-based compensation
2,016,000
855,000
Changes in assets and liabilities:
Accounts receivable
( 1,535,000 )
( 610,000 )
Inventories
( 179,000 )
( 534,000 )
Prepaid expenses and other current assets
( 29,000 )
( 32,000 )
Accounts payable and accrued expenses
369,000
1,105,000
Accrued payroll and related liabilities
( 1,141,000 )
( 684,000 )
Deferred revenue and customer deposits
7,000
( 63,000 )
NET CASH PROVIDED BY OPERATING ACTIVITIES
967,000
3,208,000
CASH FLOWS FROM INVESTING ACTIVITIES
Investment in patent and trademark assets
( 6,000 )
( 13,000 )
Purchases of property, plant and equipment and capitalized software development costs
( 404,000 )
( 211,000 )
NET CASH USED IN INVESTING ACTIVITIES
( 410,000 )
( 224,000 )
CASH FLOWS FROM FINANCING ACTIVITIES
Payments on finance lease obligations
( 3,000 )
( 1,000 )
Principal payment on SWK loan
-
( 750,000 )
Proceeds from the exercise of stock options
4,000
-
Payment of taxes upon vesting of RSUs and exercise of stock options
( 777,000 )
( 30,000 )
NET CASH USED IN FINANCING ACTIVITIES
( 776,000 )
( 781,000 )
NET CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
( 219,000 )
2,203,000
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, beginning of period
42,167,000
4,301,000
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, end of period
$ 41,948,000
$ 6,504,000
RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH
Cash and cash equivalents
$ 41,948,000
$ 6,304,000
Restricted cash
-
200,000
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD
$ 41,948,000
$ 6,504,000
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for income taxes
$ -
$ -
Cash paid for interest
$ 1,617,000
$ 415,000
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Right-of-use assets obtained in exchange for new operating
lease obligations
$ 1,036,000
$ -
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
6
HARROW
HEALTH, INC.
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
the Three Months Ended March 31, 2022 and 2021
NOTE
1. DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
Company
and Background
Harrow
Health, Inc. (together with its subsidiaries, partially owned companies and royalty arrangements unless the context indicates or otherwise
requires, the “Company” or “Harrow”) is an ophthalmic-focused healthcare company that specializes in the development,
production and sale of innovative medications that offer unique competitive advantages and serve unmet needs in the marketplace through
its subsidiaries and deconsolidated companies. The Company owns one of the nation’s leading ophthalmology-focused pharmaceutical
businesses, ImprimisRx. In addition to wholly owning ImprimisRx, the Company also has non-controlling equity positions in Surface Ophthalmics,
Inc. (“Surface”) and Melt Pharmaceuticals, Inc. (“Melt”), both companies that began as subsidiaries of Harrow.
In 2020, Harrow created Visionology, Inc. (“Visionology”), which launched a digital eye health platform business during 2021.
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,
2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022 or for any other period.
For further information, refer to the Company’s audited consolidated financial statements and footnotes thereto included in the
Company’s Annual Report on Form 10-K for the year ended December 31, 2021.
The
accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned and majority-owned
subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
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’s operations. If an entity
is not deemed to be a VIE, the Company consolidates entities in which it holds and/or controls, directly or indirectly, more than
50% of the voting rights. 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, 2022 to the significant accounting policies described in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2021.
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.
Segments
Due
to shifts in the Company’s strategic plans to further focus on growing the Company’s ImprimisRx business and suspension of
activities related to starting up development-stage pharmaceutical companies, along with changes to the Company’s organizational
and internal reporting structure, beginning in January 2022 management no longer evaluates the Company’s business in two segments
and instead focuses on the performance of the business as a single operating business.
7
Basic
and Diluted Net (Loss) Income per Common Share
Basic
net (loss) income per common share is computed by dividing net (loss) income attributable to common stockholders for the period by the
weighted average number of common shares outstanding during the period. Diluted net (loss) income per share is computed by dividing the
net (loss) income 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 warrants, outstanding during the period. Common equivalent shares
(using the treasury stock method) from stock options, unvested RSUs and warrants were 5,546,200 and 5,486,678 at March 31, 2022 and 2021,
respectively. For the three months ended March 31, 2022, the common equivalent shares are excluded in the calculation of diluted net
loss per share because the effect is anti-dilutive. Included in the basic and diluted net (loss) income 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, 2022 and 2021 was 277,405 and 223,219 , respectively.
The
following table shows the computation of basic net (loss) income per share of common stock for the three months ended March 31, 2022
and 2021:
SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE
2022
2021
For the Three Months Ended
March 31,
2022
2021
Numerator – net (loss) income attributable to Harrow Health, Inc. common stockholders
$ ( 2,438,000 )
$ 217,000
Denominator - weighted average number of shares outstanding, basic
27,226,819
26,019,255
Net (loss) income per share, basic
$ ( 0.09 )
$ 0.01
For
the three months ended March 31, 2021, the Company had net income. As a result, the Company computed diluted net income per share using
the weighted-average number of common shares and dilutive common equivalent shares outstanding during the period. Diluted common equivalent
shares for the three months ended March 31, 2021, consisted of the following:
SCHEDULE OF DILUTED COMMON EQUIVALENT SHARES
For the Three Months Ended
March 31, 2021
Diluted shares related to:
Warrants
576,275
Stock options
885,092
Dilutive common equivalent shares
1,461,367
The
following table shows the computation of diluted net (loss) income per share of common stock for the three months ended March 31, 2022
and 2021:
SCHEDULE OF DILUTED NET INCOME LOSS PER SHARES
2022
2021
For the Three Months Ended
March 31,
2022
2021
Numerator – net (loss) income attributable to Harrow Health, Inc.
$ ( 2,438,000 )
$ 217,000
Denominator – weighted average number of shares outstanding, basic
27,226,819
26,019,255
Dilutive common equivalent shares
-
1,461,367
Number of shares used for diluted earnings per share computation
27,226,819
27,480,622
Net (loss) income per share, diluted
$ ( 0.09 )
$ 0.01
8
Investment in Eton Pharmaceuticals, Inc.
As
of March 31, 2022, the Company owned 1,982,000 shares of Eton common stock, which represents less than 10 % of the equity interests of
Eton. At March 31, 2022, the fair market value of Eton’s common stock was $ 4.36 per share. In accordance with the Accounting Standards
Update (“ASU”) 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets
and Financial Liabilities , the Company recorded an unrealized investment gain (loss) from its Eton common stock position of $ 139,000
and $( 2,835,000 ) during the three months ended March 31, 2022 and 2021, respectively, related to the change in fair market value of its
investment in Eton during the measurement period. As of March 31, 2022, the fair market value of the Company’s investment in Eton
was $ 8,642,000 .
Investment
in Melt Pharmaceuticals, Inc. – Related Party
The
Company owns 3,500,000 shares of common stock of Melt (representing approximately 46 % of the equity interests as of March 31, 2022). The Company analyzes its investment in Melt and related agreements on a regular basis to evaluate its position of variable interests
in Melt. The Company has determined that it does not have the ability to control Melt, however it has the ability to exercise significant
influence over the operating and financial decisions of Melt and uses the equity method of accounting for this investment. Under this
method, the Company recognizes earnings and losses in Melt in its condensed consolidated financial statements and adjusts the carrying
amount of its investment in Melt accordingly. Any intra-entity profits and losses are eliminated. During the year ended December 31,
2021, the Company reduced the carrying value of its common stock investment in Melt to $ 0 as a result of the Company recording its share
of equity losses in Melt since its deconsolidation in 2019. As of March 31, 2022 and at the time of entering into the Melt Loan Agreement
(see Note 4), the Company owned 100 % of Melt’s indebtedness. Following the reduction of the carrying value of the Company’s
common stock investment in Melt to $ 0 , the Company began recording 100 % of the equity method losses of Melt, based on its ownership of
Melt’s total indebtedness. In addition, the Company treats interest paid in kind on the Melt Loan Agreement as an in-substance
capital contribution and reduces its investment in Melt accordingly, rather than recording interest income. The Company has no other
requirements to advance funds to Melt.
The
following table summarizes the Company’s investments in Melt as of March 31, 2022:
SCHEDULE OF INVESTMENT
Cost
Share of Equity
Paid-in-Kind
In-substance Capital
Net
Basis
Method Losses
Interest
Contributions
Carrying value
Common stock
$ 5,810,000
$ ( 5,810,000 )
$ -
$
$
Loan
13,500,000
( 5,253,000 )
1,021,000
( 1,021,000 )
8,247,000
$ 19,310,000
$ ( 11,063,000 )
$ 1,021,000
$ ( 1,021,000 )
$ 8,247,000
During
the three months ended March 31, 2022 and 2021, the Company recorded $ 30,000
due from Melt for reimbursable expenses and
amounts payable pursuant to a Management Services Agreement between the Company and Melt (the “Melt MSA”), which are included
in prepaid expenses and other current assets in the accompanying condensed consolidated balance sheets.
See
Note 4 for more information and related party disclosure regarding Melt.
Investment
in Surface Ophthalmics, Inc. – Related Party
The
Company owns 3,500,000 common shares of Surface (representing approximately 20 % of Surface’s equity interests following the closing
of a round of financing completed by Surface in July 2021) and uses the equity method of accounting for this investment, as
management has determined that the Company has the ability to exercise significant influence over the operating and financial decisions
of Surface. Under this method, the Company recognizes earnings and losses in Surface in its consolidated financial statements and adjusts
the carrying amount of its investment in Surface accordingly. The Company’s share of earnings and losses are based on the Company’s
ownership interest of Surface. Any intra-entity profits and losses are eliminated. During the year ended December 31, 2021, the Company
reduced its common stock investment in Surface to $ 0 as a result of the Company recording its share of equity losses of Surface. The
Company has no other investments in Surface.
The
following table summarizes the Company’s investment in Surface as of March 31, 2022:
SCHEDULE OF INVESTMENT
Cost
Share of Equity
Net
Basis
Method Losses
Carrying value
Common stock
$ 5,320,000
$ ( 5,320,000 )
$ -
See
Note 5 for more information and related party disclosure regarding Surface.
9
Impairment
of Equity Method Investments and Note Receivable
On
a quarterly basis, management assesses whether there are any indicators that the carrying value of the Company’s equity method
investments and note receivable 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 and note receivable. At March 31, 2022 and December 31, 2021, no indicators of impairment existed.
NOTE
3. REVENUES
The
Company accounts for contracts with customers in accordance with Accounting Standards Codification (“ASC”) 606, Revenues
from Contracts with Customers. The Company has two primary streams of revenue: (1) revenue recognized from its sale of products within
pharmacy services and (2) revenue recognized from intellectual property license and asset purchase agreements.
Product
Revenues
The
Company sells prescription drugs directly through its pharmacy and outsourcing facility. 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 exists with a customer at the time the prescription or order is received by the Company.
2.
Identify
the performance obligations in the contract: The order received contains the performance obligations to be met, in almost all cases
the product the customer is wishing to receive. If we are unable to be meet the performance obligations the customer is notified.
3.
Determine
the transaction price: the transaction price is based on the product being sold to the customer, and any related customer discounts.
These amounts are pre-determined and built into the Company’s order management software.
4.
Allocate
the transaction price to the performance obligations in the contract: The transaction price associated with the product(s) being
ordered is allocated according to the pre-determined amounts.
5.
Recognize
revenue when (or as) the entity satisfies a performance obligation: At the time of shipment from the pharmacy or outsourcing facility
the performance obligation has been met.
The
following revenue recognition policy has been established for the Company’s pharmacy services:
Revenues
generated from prescription or office use drugs sold by the Company’s pharmacies and outsourcing facility are recognized when the
prescription is shipped. At the time of shipment, the pharmacy services has performed substantially all of its obligations under its
client contracts and does not experience a significant level of returns or reshipments. Determination of criteria (3) and (4) is based
on management’s judgments regarding the fixed nature of the selling prices of the products delivered and the collectability of
those amounts. The Company records reductions to revenue for discounts at the time of the initial sale. Estimated returns and allowances
and other adjustments are provided for in the same period during which the related sales are recorded and are based on actual returns
history. The rate of returns is analyzed annually to determine historical returns experience. If the historical data we use to calculate
these estimates do not properly reflect future returns, then a change in the allowance would be made in the period in which such a determination
is made and revenues in that period could be materially affected. The Company will defer any revenues received for a product that has
not been delivered or is subject to refund until such time that the Company and the customer jointly determine that the product has been
delivered and no refund will be required.
10
Commission
Revenues
The
Company has entered into an agreement whereby it is paid a fee calculated based on sales the Company generates from a pharmaceutical
product that is owned by a third party. The revenue earned from this arrangement is recognized at the time a customer has ordered the
pharmaceutical product and it has shipped from the third party (or one of its distributors or affiliates), 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.
Transfer
of Acquired Product Profit Revenues
The
Company has entered into an agreement whereby it purchased the exclusive commercial rights to assets associated with certain ophthalmic
products from another pharmaceutical company (the “Seller”). During a temporary, six month transition period, the Seller
will 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 is recognized at the time profit from the products sales has been calculated
by the Seller and confirmed by the Company, typically on a monthly basis, at which point there is no future performance obligation required
by the Company and no consequential continuing involvement on the Company’s part to recognize the associated revenue. On
a quarterly basis, the Seller invoices the Company for all credits and reimbursements (“Chargebacks”) made to customers related
to the products. The Company uses historical actual experience to estimate Chargebacks associated with the net profit transferred. The
estimate is recorded as a reduction in revenues in the Company’s condensed consolidated statements of operations and
accounts receivable in the condensed consolidated balance sheets, at the time the revenue is recognized.
Intellectual
Property License Revenues
The
Company currently holds five intellectual property licenses and related agreements in which the Company has agreed to license or sell
to a customer with the right to access the Company’s intellectual property. License arrangements may consist of non-refundable
upfront license fees, data transfer fees, research reimbursement payments, exclusive license rights to patented or patent pending compounds,
technology access fees, and various performance or sales milestones. These arrangements can be multiple-element arrangements, the revenue
of which is recognized at the point in time that the performance obligation is met.
Non-refundable
fees that are not contingent on any future performance by the Company and require no consequential continuing involvement on the part
of the Company are recognized as revenue when the license term commences and the licensed data, technology, compounded drug preparation
and/or other deliverable is delivered. Such deliverables may include physical quantities of compounded drug preparations, design of the
compounded drug preparations and structure-activity relationships, the conceptual framework and mechanism of action, and rights to the
patents or patent applications for such compounded drug preparations. The Company defers recognition of non-refundable fees if it has
continuing performance obligations without which the technology, right, product or service conveyed in conjunction with the non-refundable
fee has no utility to the licensee and that are separate and independent of the Company’s performance under the other elements
of the arrangement. In addition, if the Company’s continued involvement is required, through research and development services
that are related to its proprietary know-how and expertise of the delivered technology or can only be performed by the Company, then
such non-refundable fees are deferred and recognized over the period of continuing involvement. Guaranteed minimum annual royalties are
recognized on a straight-line basis over the applicable term.
Revenue
disaggregated by revenue source for the three months ended March 31, 2022 and 2021, consists of the following:
SCHEDULE
OF DISAGGREGATED REVENUE
2022
2021
For the Three Months Ended March 31,
2022
2021
Product sales, net
$ 20,340,000
$ 14,948,000
Commissions
1,320,000
485,000
Transfer of profit
460,000
-
License
-
10,000
Total revenues
$ 22,120,000
$ 15,443,000
Deferred
revenue and customer deposits at March 31, 2022 and December 31, 2021 were $ 23,000 and $ 16,000 , respectively. All deferred revenue and
customer deposit amounts at December 31, 2021 were recognized as revenue during the three months ended March 31, 2022.
11
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 Asset Purchase Agreement”). Pursuant
to the terms of the Melt Asset Purchase Agreement, Melt was assigned certain intellectual property and related rights from the Company
to develop, formulate, make, sell, and sub-license certain Company conscious sedation and analgesia related formulations (collectively,
the “Melt Products”). Under the terms of the Melt Asset Purchase Agreement, Melt is required to make mid-single digit royalty
payments to the Company on net sales of the Melt Products while any patent rights remain outstanding, as well as other conditions.
In
February 2019, the Company and Melt entered into the Melt MSA, whereby the Company provides to Melt certain administrative services and
support, including bookkeeping, web services and human resources related activities, and Melt is required to pay the Company a monthly
amount of $ 10,000 . As of March 31, 2022 and December 31, 2021, the Company was due $ 70,000 and $ 48,000 , respectively, from Melt for reimbursable
expenses and amounts due under the Melt MSA. Melt did not make any payments to the Company during the three months ended March 31, 2022.
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. Following Mr. Baum’s departure, the Company no longer has any representation on Melt’s
board of directors.
The
unaudited condensed results of operations information of Melt is summarized below:
SCHEDULE OF CONDENSED INCOME STATEMENT
2022
2021
For the Three Months Ended
March 31,
2022
2021
Revenues, net
$ -
$ -
Loss from operations
( 3,337,000 )
( 1,099,000 )
Net loss
$ ( 3,337,000 )
$ ( 1,099,000 )
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE OF CONDENSED BALANCE SHEET
At March 31,
At December 31,
2022
2021
Current assets
$ 9,025,000
$ 11,278,000
Non-current assets
360,000
-
Total assets
$ 9,385,000
$ 11,278,000
Total liabilities
$ 17,313,000
$ 15,732,000
Total preferred stock and stockholders’ deficit
( 7,928,000 )
( 4,454,000 )
Total liabilities and stockholders’ deficit
$ 9,385,000
$ 11,278,000
Melt
Note Receivable
In
September 2021, the Company entered into a loan and security agreement in the principal amount of $ 13,500,000 (the “Melt Loan Agreement”),
as lender, with Melt, as borrower. Amounts borrowed under the Melt Loan Agreement bear interest at twelve and one-half percent ( 12.50 %)
per annum, which interest can be paid in-kind at the option of Melt until the maturity date. The Melt Loan Agreement permits Melt to
pay interest only on the principal amount loaned thereunder through the term and all amounts owed will be due and payable on September
1, 2022. Melt may elect to prepay all, but not less than all, of the amounts owed prior to the maturity date at any time without penalty.
12
Melt
has granted the Company a security interest in substantially all of its personal property, rights and assets, including intellectual
property rights, to secure the payment of all amounts owed under the Melt Loan Agreement. The Melt Loan Agreement contains customary
representations, warranties and covenants, including covenants by Melt limiting additional indebtedness, liens, mergers and acquisitions,
dispositions, investments, distributions, subordinated debt, and transactions with affiliates. The Melt Loan Agreement includes customary
events of default, and upon the occurrence of an event of default (subject to cure periods for certain events of default), all amounts
owed by Melt thereunder may be declared immediately due and payable by the Company, and the interest rate on the loan may be increased
by three percent ( 3 %) per annum. See Note 17 regarding an Amendment to the Melt Loan Agreement entered into in April 2022.
In
connection with the Melt Loan Agreement, the Company and Melt entered into a Right of First Refusal Agreement providing the Company with
the right, but not the obligation, to match any offer received by Melt associated with the commercial rights to any of Melt’s drug
candidates for a period of five years following the effective date of the Melt Loan Agreement.
The
net funds received by Melt excluded $ 908,000 for amounts owed to the Company for reimbursable expenses and amounts due under the Melt
MSA prior to the effective date of the note receivable.
NOTE
5. INVESTMENT IN SURFACE OPHTHALMICS, INC. - RELATED PARTY TRANSACTIONS
The
Company entered into an asset purchase and license agreement with Surface in 2017 and amended it in April 2018 (the “Surface License
Agreements”). Pursuant to the terms of the Surface License Agreements, the Company assigned and licensed to Surface certain intellectual
property and related rights associated with Surface’s drug candidates (collectively, the “Surface Products”). Surface
is required to make mid-single digit royalty payments to the Company on net sales of the Surface Products while any patent rights remain
outstanding.
As
of March 31, 2022, the Company owned 3,500,000 shares of Surface common stock (representing approximately 20 % of Surface’s issued
and outstanding equity interests). A Company director, Richard L. Lindstrom, and the Company’s Chief Executive Officer, Mark L.
Baum, are directors of Surface. Dr. Lindstrom is a principal of Flying L Partners, an affiliate of an investor who purchased Surface
Series A Preferred Stock.
The
unaudited condensed results of operations information of Surface is summarized below:
SUMMARY OF CONDENSED INCOME STATEMENT
2022
2021
For the Three Months Ended March 31,
2022
2021
Revenues, net
$ -
$ -
Loss from operations
( 1,996,000 )
( 2,831,000 )
Net loss
$ ( 1,996,000 )
$ ( 2,831,000 )
The
unaudited condensed balance sheet information of Surface is summarized below:
SUMMARY OF CONDENSED BALANCE SHEET
At March 31,
At December 31,
2022
2021
Current assets
$ 19,920,000
$ 21,731,000
Non-current assets
411,000
412,000
Total assets
$ 20,331,000
$ 22,143,000
Total liabilities
$ 1,937,000
$ 1,514,000
Total preferred stock and stockholders’ deficit
18,394,000
20,629,000
Total liabilities and stockholders’ equity
$ 20,331,000
$ 22,143,000
NOTE
6. INVENTORIES
Inventories
are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, commercial pharmaceutical
products, related laboratory supplies and active pharmaceutical ingredients. The composition of inventories as of March 31, 2022 and
December 31, 2021 was as follows:
SCHEDULE OF INVENTORIES
March 31, 2022
December 31,
2021
Raw materials
$ 2,441,000
$ 2,441,000
Work in progress
44,000
-
Finished goods
1,911,000
1,776,000
Total inventories
$ 4,396,000
$ 4,217,000
13
NOTE
7. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets at March 31, 2022 and December 31, 2021, consisted of the following:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
March 31, 2022
December 31, 2021
Prepaid insurance
$ 455,000
$ 728,000
Due from Melt Pharmaceuticals
70,000
48,000
Other prepaid expenses
757,000
437,000
Deposits and other current assets
52,000
92,000
Total prepaid expenses and other current assets
$ 1,334,000
$ 1,305,000
NOTE
8. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment at March 31, 2022 and December 31, 2021, consisted of the following:
SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT
March 31, 2022
December 31,
2021
Property, plant and equipment, net:
Computer hardware
$ 786,000
$ 772,000
Furniture and equipment
521,000
443,000
Lab and pharmacy equipment
4,142,000
4,056,000
Leasehold improvements
5,728,000
5,703,000
Property, plant and equipment, gross
11,177,000
10,974,000
Accumulated depreciation
( 8,209,000 )
( 7,833,000 )
Property,
plant and equipment, net
$ 2,968,000
$ 3,141,000
For
the three months ended March 31, 2022 and 2021, depreciation related to the property, plant and equipment was $ 376,000 and $ 436,000 ,
respectively.
NOTE
9. CAPITALIZED SOFTWARE DEVELOPMENT COSTS
Capitalized
software development costs at March 31, 2022 and December 31, 2021 consisted of the following:
SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS
March 31, 2022
December 31, 2021
Capitalized internal-use software development costs
$ 942,000
$ 942,000
Acquired third-party software license for internal-use
159,000
159,000
Total gross capitalized software for internal-use
1,101,000
1,101,000
Accumulated amortization
( 612,000 )
( 569,000 )
Capitalized internal-use software in process
982,000
781,000
Total
finite lived intangible assets net
$ 1,471,000
$ 1,313,000
The
Company recorded amortization expense of $ 43,000 and $ 28,000 related to capitalized software development costs during the three months
ended March 31, 2022 and 2021, respectively.
14
NOTE
10. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at March 31, 2022 consisted of the following:
SCHEDULE OF INTANGIBLE ASSETS
Amortization
Periods
(in years)
Cost
Accumulated
Amortization
Impairment
Net
Carrying Value
Patents
17 - 19
$ 972,000
$ ( 97,000 )
$ -
$ 875,000
Licenses
20
100,000
( 15,000 )
-
85,000
Trademarks
Indefinite
260,000
-
-
260,000
Acquired NDAs
10
13,635,000
( 341,000 )
-
13,294,000
Customer relationships
3 - 15
1,519,000
( 619,000 )
-
900,000
Trade name
5
5,000
( 5,000 )
-
-
Non-competition clause
3 - 4
50,000
( 50,000 )
-
-
State pharmacy licenses
25
8,000
( 7,000 )
-
1,000
$ 16,549,000
$ ( 1,134,000 )
$ -
$ 15,415,000
Amortization
expense for intangible assets for the three months ended March 31, 2022 and 2021 was as follows:
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
2022
2021
For the
Three Months Ended
March 31,
2022
2021
Patents
$ 22,000
$ 6,000
Licenses
8,000
1,000
Acquired NDAs
341,000
-
Customer relationships
33,000
33,000
Amortization
of intangible assets
$ 404,000
$ 40,000
Estimated
future amortization expense for the Company’s intangible assets at March 31, 2022 is as follows:
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE
Remainder of 2022
$ 1,194,000
2023
1,592,000
2024
1,592,000
2025
1,592,000
2026
1,595,000
Thereafter
7,590,000
Intangible assets
$ 15,155,000
NOTE
11. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses at March 31, 2022 and December 31, 2021 consisted of the following:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
March 31, 2022
December 31,
2021
Accounts payable
$ 5,595,000
$ 5,174,000
Other accrued expenses
49,000
49,000
Accrued interest
1,114,000
1,114,000
Total accounts payable and accrued expenses
6,758,000
6,337,000
15
NOTE
12. DEBT
8.625%
Senior Notes Due 2026
In
April 2021, the Company closed an offering of $ 50,000,000 aggregate principal amount of 8.625% senior notes due April 2026, and in May
2021 issued an additional $ 5,000,000 of such notes pursuant to the full exercise of the underwriters’ option to purchase additional
notes (collectively, the “April Notes”). The April Notes were sold to investors at a par value of $ 25.00 per April Note and
the offering resulted in net proceeds to the Company of approximately $ 51,909,000 after deducting underwriting discounts and commissions
and expenses of $ 3,091,000 . In June 2021, in a further issuance of the April Notes, the Company sold an additional $ 20,000,000 aggregate
principal amount of such notes (the “June Notes,” and together with the April Notes, the “Notes”), at a price
of $ 25.75 per June Note, with interest of $ 278,000 on the June Notes being accrued from April 20, 2021 as of the date of issuance. The
June offering resulted in net proceeds to the Company of approximately $ 19,164,000 after deducting underwriting discounts and commissions
and expenses of $ 1,158,000 and a premium on note issuance of $ 322,000 . The June Notes are treated as a single series with the April Notes
under the indenture governing the April Notes, dated as of April 20, 2021, and have the same terms as the April Notes (other than the
initial offering price and issue date). The Notes are senior unsecured obligations of the Company and rank equally in right of payment
with all of our other existing and future senior unsecured and unsubordinated indebtedness. The Notes are effectively subordinated in
right of payment to all of the Company’s existing and future secured indebtedness and structurally subordinated to all existing
and future indebtedness of the Company’s subsidiaries, including trade payables. The Notes bear interest at a rate of 8.625 % per
annum. Interest on the Notes is payable quarterly in arrears on January 31, April 30, July 31 and October 31 of each year, commencing
on July 31, 2021. The Notes will mature on April 30, 2026. The issuance costs were recorded as a debt discount and are being amortized
as interest expense, net of the amortization of the premium on note issuance, over the term of the Notes using the effective interest
rate method.
Prior
to February 1, 2026, the Company may, at its option, redeem the Notes, in whole at any time or in part from time to time, at a redemption
price equal to 100% of the principal amount of the Notes to be redeemed , plus a make-whole amount, if any, plus accrued and unpaid interest
to, but excluding, the date of redemption. The Company may redeem the Notes for cash in whole or in part at any time at our option on
or after February 1, 2026 and prior to maturity, at a price equal to 100% of their principal amount, plus accrued and unpaid interest
to, but excluding, the date of redemption. On and after any redemption date, interest will cease to accrue on the redeemed Notes.
Interest
expense related to the Notes totaled $ 1,810,000 for the three months ended March 31, 2022, and included amortization of debt issuance
costs and discount of $ 193,000 for three months ended March 31, 2022.
At
March 31, 2022, future minimum payments under the Company’s debt were as follows:
SUMMARY OF FUTURE MINIMUM PAYMENTS
Amount
Remainder of 2022
$ 4,852,000
2023
6,469,000
2024
6,469,000
2025
6,469,000
2026
77,158,000
Total minimum payments
101,417,000
Less: amount representing interest payments
( 26,417,000 )
Notes payable, gross
75,000,000
Less: unamortized discount, net of premium
( 3,153,000 )
Notes payable, net of unamortized discount
$ 71,847,000
NOTE
13. LEASES
The
Company leases office and laboratory space under non-cancelable operating leases listed below. These lease agreements have remaining
terms between one to five years and contain various clauses for renewal at the Company’s option.
●
An
operating lease for 5,789 square feet of office space in Carlsbad, California, which commenced in January 2022 and will expire in
July 2027 .
●
An
operating lease for 35,326 square feet of lab, warehouse and office space in Ledgewood, New Jersey that expires in July 2026 , with
an option to extend the term for two additional five-year periods. This includes an amendment that was made effective July 2020 that
extended the term of the original lease and added 1,400 of additional square footage to the lease and another amendment entered into
in May 2021 that extended the term of the lease to July 2027 and added 8,900 square feet of space.
●
An
operating lease for 5,500 square feet of office space in Nashville, Tennessee that expires in December 2024 , with an option to extend
the term for two additional five-year periods.
16
At
March 31, 2022, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases
held by the Company were 6.34 % and 13.45 years, respectively.
During
the three months ended March 31, 2022 and 2021, cash paid for amounts included for the operating lease liabilities was $ 166,000 and $ 251,000 ,
respectively, and the Company recorded operating lease expense of $ 238,000 and $ 261,000 , included in selling, general and administrative
expenses, respectively.
Future
lease payments under operating leases as of March 31, 2022 were as follows :
SCHEDULE OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES
Operating Leases
Remainder of 2022
$ 655,000
2023
944,000
2024
970,000
2025
796,000
2026
810,000
Thereafter
6,648,000
Total minimum lease payments
10,823,000
Less: amount representing interest payments
( 3,555,000 )
Total operating lease liabilities
7,268,000
Less: current portion, operating lease liabilities
( 445,000 )
Operating lease liabilities, net of current portion
$ 6,823,000
The
Company also has a finance lease that is included in its lease accounting but is not considered significant.
Future
lease payments under the non-cancelable finance lease as of March 31, 2022 were as follows :
SCHEDULE OF FUTURE LEASE PAYMENT UNDER FINANCE LEASE
Finance Lease
Remainder of 2022
$ 6,000
2023
9,000
2024
1,000
Total minimum lease payments
16,000
Less: amount representing interest payments
( 1,000 )
Present value of future minimum lease payments
15,000
Less: current portion, finance lease obligation
( 8,000 )
Finance lease obligation, net of current portion
$ 7,000
At
March 31, 2022, the incremental borrowing rate and the remaining lease term for the finance lease held by the Company were 6.36 % and
1.83 years, respectively.
For
the three months ended March 31, 2022 and 2021, depreciation expense related to the equipment held under the finance lease obligation
was $ 2,000 and $ 2,000 , respectively.
For
the three months ended March 31, 2022 and 2021, cash paid and expense recognized for interest expense related to the finance lease obligation
was $ 0 and $ 1,000 , respectively.
NOTE
14. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Preferred
Stock
At
March 31, 2022 and December 31, 2021, the Company had 5,000,000 shares of preferred stock, $ 0.001 par value, authorized and no shares
of preferred stock issued and outstanding.
Common
Stock
During
the three months ended March 31, 2022, the Company issued 53,594 shares of common stock to Mark L. Baum, the Company’s Chief Executive
Officer, upon the cashless exercise of options to purchase 125,000 shares at an exercise price of $ 2.40 per share. The Company withheld
from Mr. Baum 36,014 shares as consideration for the cashless exercise and an additional 35,392 shares for payroll tax obligations totaling
$ 295,000 .
17
50,000
RSUs granted in February 2019 to Andrew R. Boll, the Company’s Chief Financial Officer, vested, and in February 2022, the Company
issued 29,395 shares of common stock to Mr. Boll, net of 20,605 shares of common stock withheld for payroll tax withholdings totaling
$ 162,000 .
50,000
RSUs granted in February 2019 to John P. Saharek, the President of ImprimisRx, vested, and in February 2022, the Company issued 24,077
shares of common stock to Mr. Saharek, net of 25,923 shares of common stock withheld for payroll tax withholdings totaling $ 204,000 .
35,000
RSUs granted in February 2019 vested, and in February 2022, the Company issued 20,298 shares of common stock, net of 14,702 shares of
common stock withheld for payroll tax withholdings totaling $ 116,000 .
During
the three months ended March 31, 2022, the Company issued 1,000 shares of common stock and received net proceeds of $ 4,000 upon the exercise
of options to purchase 1,000 shares of common stock with exercise price of $ 3.95 per share.
During
the three months ended March 31, 2022, 9,644 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 resigns.
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 March 31, 2022, the 2017 Plan provides for the issuance of a maximum of 6,000,000
shares of the Company’s common stock. The purposes of the Plans are to attract and retain directors, officers, consultants, advisors
and employees whose services are considered valuable, to encourage a sense of proprietorship and to stimulate an active interest of such
persons in the Company’s development and financial success. Under the Plans, the Company is authorized to issue incentive stock
options intended to qualify under Section 422 of the 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 2,229,399 shares available for future issuances under the 2017 Plan at March 31, 2022.
Stock
Options
A
summary of stock option activity under the Plans for the three months ended March 31, 2022 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, 2022
3,039,546
$ 5.52
Options granted
170,250
$ 7.60
Options exercised
( 126,000 )
$ 2.41
Options cancelled/forfeited
-
$ -
Options outstanding – March 31, 2022
3,083,796
$ 5.76
5.01
$ 4,781,000
Options exercisable
2,408,629
$ 5.29
4.61
$ 4,639,000
Options vested and expected to vest
3,083,796
$ 5.76
5.01
$ 4,781,000
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, 2022, based on the closing price of the Company’s common stock of $ 6.82 on that
date.
18
During
the three months ended March 31, 2022, the Company granted stock options to certain employees and a consultant. 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 10 years. Vesting terms for options granted
to employees during the three months ended March 31, 2022 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
2022
Weighted-average fair value of options granted
$ 4.65
Expected terms (in years)
6.11
Expected volatility
70 %
Risk-free interest rate
1.54 %
Dividend yield
-
The
following table summarizes information about stock options outstanding and exercisable at March 31, 2022:
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
312,887
5.70
$ 1.72
312,887
$ 1.72
$ 2.23 - $ 2.60
313,068
4.84
$ 2.26
312,943
$ 2.26
$ 2.76 - $ 3.50
25,500
7.95
$ 3.49
12,906
$ 3.48
$ 3.95
370,000
4.00
$ 3.95
370,000
$ 3.95
$ 4.08 - $ 6.30
578,850
5.71
$ 5.76
525,027
$ 5.85
$ 6.81 - $ 7.37
388,995
6.27
$ 7.30
297,495
$ 7.30
$ 7.52 - $ 7.79
221,823
8.33
$ 7.61
49,323
$ 7.66
$ 7.87
600,000
3.33
$ 7.87
300,000
$ 7.87
$ 7.89 - $ 8.98
92,673
7.47
$ 8.16
48,048
$ 8.22
$ 8.99
180,000
1.09
$ 8.99
180,000
$ 8.99
$ 1.47 - $ 8.99
3,083,796
5.01
$ 5.76
2,408,629
$ 5.29
As
of March 31, 2022, there was approximately $ 1,806,000 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 4.89 years. The stock-based
compensation for all stock options was $ 272,000 and $ 452,000 during the three months ended March 31, 2022 and 2021, respectively.
The
intrinsic value of options exercised during the three months ended March 31, 2022 was $ 745,000 .
19
Restricted
Stock Units/Performance Stock Units
RSU
awards are granted subject to certain vesting requirements and other restrictions, including 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 (including performance stock units) and related information for the three months ended March
31, 2022 is as follows:
SCHEDULE
OF RESTRICTED STOCK UNITS ACTIVITY
Number of RSUs
Weighted Average Grant Date Fair Value
RSUs unvested - January 1, 2022
2,233,202
$ 6.78
RSUs granted
-
$ -
RSUs vested
( 144,644 )
$ 6.57
RSUs cancelled/forfeited
-
-
RSUs unvested at March 31, 2022
2,088,558
$ 6.79
As
of March 31, 2022, the total unrecognized compensation expense related to unvested RSUs was approximately $ 8,756,000 , which is expected
to be recognized over a weighted-average period of 1.33 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, 2022 and 2021 was $ 1,744,000 and $ 346,000 , respectively.
Warrants
From
time to time, the Company issues warrants to purchase shares of the Company’s common stock to investors, lenders, underwriters
and other non-employees for services rendered or to be rendered in the future, or pursuant to settlement agreements.
A
summary of warrant activity for the three months ended March 31, 2022 is as follows:
SCHEDULE
OF WARRANTS ACTIVITY
Number of
Shares Subject
to Warrants Outstanding
Weighted
Average
Exercise Price
Warrants outstanding - January 1, 2022
373,847
$ 2.08
Granted
-
Exercised
-
Expired
-
Warrants outstanding and exercisable - March 31, 2022
373,847
$ 2.08
Weighted average remaining contractual life of the outstanding warrants in years - March 31, 2022
2.3
Warrants
outstanding and exercisable as of March 31, 2022 are as follows:
SCHEDULE
OF WARRANTS OUTSTANDING AND WARRANTS EXERCISABLE
Warrant Series
Issue Date
Warrants
Outstanding
Exercise
Price
Expiration
Date
Lender warrants
7/19/2017
373,847
$ 2.08
7/19/2024
Subsidiary
Stock-Based Transactions
The
Company recognized $ 0 and $ 57,000 in stock-based compensation expense related to subsidiary stock options during the three months ended
March 31, 2022 and 2021.
20
Stock-Based
Compensation Summary
The
Company recorded stock-based compensation related to equity instruments granted to employees, directors and consultants as follows:
SCHEDULE
OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES DIRECTORS CONSULTANTS
For the Three Months Ended
March 31,
2022
2021
Employees - selling, general and administrative
$ 1,676,000
$ 755,000
Employees – research and development
186,000
-
Directors - selling, general and administrative
100,000
100,000
Consultants – research and development
54,000
-
Total
$ 2,016,000
$ 855,000
NOTE
15. COMMITMENTS AND CONTINGENCIES
Legal
General
and Other
In
the ordinary course of business, the Company may face various claims brought by third parties and it may, from time to time, make claims
or take legal actions to assert its rights, including intellectual property disputes, contractual disputes and other commercial disputes.
Any of these claims could subject the Company to litigation.
Product
and Professional Liability
Product
and professional liability litigation represents an inherent risk to all firms in the pharmaceutical and pharmacy industry. We utilize
traditional third-party insurance policies with regard to our product and professional liability claims. Such insurance coverage at any
given time reflects current market conditions, including cost and availability, when the policy is written.
Indemnities
In
addition to the indemnification provisions contained in the Company’s governing documents, the Company generally enters into separate
indemnification agreements with each of the Company’s directors and officers. These agreements require the Company, among other
things, to indemnify the director or officer against specified expenses and liabilities, such as attorneys’ fees, judgments, fines
and settlements, paid by the individual in connection with any action, suit or proceeding arising out of the individual’s status
or service as the Company’s director or officer, other than liabilities arising from willful misconduct or conduct that is knowingly
fraudulent or deliberately dishonest, and to advance expenses incurred by the individual in connection with any proceeding against the
individual with respect to which the individual may be entitled to indemnification by the Company. The Company also indemnifies its lessors
in connection with its facility leases for certain claims arising from the use of the facilities. These indemnities do not provide for
any limitation of the maximum potential future payments the Company could be obligated to make. Historically, the Company has not incurred
any payments for these obligations and, therefore, no liabilities have been recorded for these indemnities in the accompanying condensed
consolidated balance sheets.
Klarity
License Agreement – Related Party
The
Company entered into a license agreement in April 2017, as amended in April 2018 (the “Klarity License Agreement”), with
Richard L. Lindstrom, M.D., a member of its Board of Directors. Pursuant to the terms of the Klarity License Agreement, the Company licensed
certain intellectual property and related rights from Dr. Lindstrom to develop, formulate, make, sell, and sub-license the topical ophthalmic
solution Klarity designed to protect and rehabilitate the ocular surface (the “Klarity Product”).
Under
the terms of the Klarity License Agreement, the Company is required to make royalty payments to Dr. Lindstrom ranging from 3% - 6% of
net sales, dependent upon the final formulation of the Klarity Product sold . In addition, the Company was required to make certain milestone
payments to Dr. Lindstrom. All of the above referenced milestone payments were payable at the Company’s election in cash or shares
of the Company’s restricted common stock. Payments totaling $ 30,000 and $ 35,000 were made during the three months ended March 31,
2022 and 2021, respectively. $ 71,000 and $ 35,000 were incurred as royalty expenses during the three months ended March 31, 2022 and 2021,
respectively, and was included in accounts payable to Dr. Lindstrom.
21
Injectable
Asset Purchase Agreement – Related Party
In
December 2019, the Company entered into an asset purchase agreement (the “Lindstrom APA”) with Dr. Lindstrom, a member of
its Board of Directors. Pursuant to the terms of the Lindstrom APA, the Company acquired certain intellectual property and related rights
from Dr. Lindstrom to develop, formulate, make, sell, and sub-license an ophthalmic injectable product (the “Lindstrom Product”).
Under
the terms of the Lindstrom APA, the Company is required to make royalty payments to Dr. Lindstrom ranging from 2% to 3% of net sales,
dependent upon the final formulation and patent protection of the Lindstrom Product sold . In addition, the Company is required to make
certain milestone payments to Dr. Lindstrom including an initial payment of $ 33,000 upon execution of the Lindstrom APA. Dr. Lindstrom
was paid $ 8,000 and $ 7,000 in cash during the three months ended March 31, 2022 and 2021, respectively. The Company incurred $ 7,000 and
$ 7,000 for royalty expenses related to the Lindstrom APA during the three months ended March 31, 2022 and 2021.
Eyepoint
Commercial Alliance Agreement
In
August 2020, the Company, through its wholly owned subsidiary ImprimisRx, LLC, entered into a Commercial Alliance Agreement (the “Dexycu
Agreement”) with Eyepoint Pharmaceuticals, Inc. (“Eyepoint”), pursuant to which Eyepoint granted the Company the non-exclusive
right to co-promote DEXYCU ® (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation
following ocular surgery in the United States. Pursuant
to the Dexycu Agreement , Eyepoint will pay the Company a fee calculated based on the quarterly
sales of DEXYCU in excess of predefined volumes to specific customers of the Company in the U.S. Under the terms of the Dexycu
Agreement , the Company shall use commercially reasonable efforts to promote and market DEXYCU in the U.S.
The
Dexycu Agreement expires on August 1, 2025 , subject to early termination in accordance with
the terms set forth therein. Either party may terminate the Dexycu Agreement, subject to specified
notice periods and limitations, in the event of (i) uncured material breach by the other party or (ii) if DEXYCU ceases to have
“pass-through” payment status. In addition, subject to certain limitations, the Company may terminate the Dexycu
Agreement (i) for convenience subject to an extended specified notice period or (ii) in the event Eyepoint undergoes a change
of control. Eyepoint may terminate the Dexycu Agreement , subject to specified notice periods
and specified limitations, if the Company fails to achieve certain minimum sales levels during specified periods. During the three months
ended March 31, 2022 and 2021, the Company recorded $ 1,320,000 and $ 485,000 , respectively, in commission revenues related to the Dexycu
Agreement.
Sales
and Marketing Agreements
The
Company has entered various sales and marketing agreements with certain organizations to provide exclusive and non-exclusive sales and
marketing representation services to Harrow in select geographies in the U.S. in connection with the Company’s ophthalmic pharmaceutical
compounded formulations or related products.
Under
the terms of the sales and marketing agreements, the Company is generally required to make commission payments equal to 10 % - 14 % of
net sales for products above and beyond the initial existing sales amounts . In addition, the Company is required to make periodic milestone
payments to certain organizations in shares of the Company’s restricted common stock if net sales in the assigned territory reach
certain future levels by the end of their terms. Commission expenses of $ 1,047,000 and $ 804,000 were incurred under these agreements during the three months ended March 31, 2022 and 2021, respectively.
Asset
Purchase, License and Related Agreements
The
Company has acquired and sourced intellectual property rights related to certain proprietary innovations from certain inventors and related
parties (the “Inventors”) through multiple asset purchase agreements, license agreements, strategic agreements and commission
agreements. In general, these agreements provide that the Inventors will cooperate with the Company in obtaining patent protection for
the acquired intellectual property and that the Company will use commercially reasonable efforts to research, develop and commercialize
a product based on the acquired intellectual property. In addition, the Company has acquired a right of first refusal on additional intellectual
property and drug development opportunities presented by these Inventors.
22
In
consideration for the acquisition of the intellectual property rights, the Company is obligated to make payments to the Inventors based
on the completion of certain milestones, generally consisting of: (1) a payment payable within 30 days after the issuance of the first
patent in the United States arising from the acquired intellectual property (if any); (2) a payment payable within 30 days after the
Company files the first investigational new drug application (“IND”) with the U.S. Food and Drug Administration (“FDA”)
for the first product arising from the acquired intellectual property (if any); (3) for certain of the Inventors, a payment payable within
30 days after the Company files the first new drug application with the FDA for the first product arising from the acquired intellectual
property (if any); and (4) certain royalty payments based on the net receipts received by the Company in connection with the sale or
licensing of any product based on the acquired intellectual property (if any), after deducting (among other things) the Company’s
development costs associated with such product. If, following five years after the date of the applicable asset purchase agreement, the
Company either (a) for certain of the Inventors, has not filed an IND or, for the remaining Inventors, has not initiated a study where
data is derived, or (b) has failed to generate royalty payments to the Inventors for any product based on the acquired intellectual property,
the Inventors may terminate the applicable asset purchase agreement and request that the Company re-assign the acquired technology to
the Inventors. During the three months ended March 31, 2022 and 2021, $ 213,000 and $ 232,000 were incurred under these agreements as royalty
expenses, respectively.
Sintetica
Agreement
In
July 2021, the Company entered into a License and Supply Agreement (the “Sintetica Agreement”) with Sintetica S.A. (“Sintetica”),
pursuant to which Sintetica granted the Company the exclusive license and marketing rights to its patented ophthalmic drug candidate
(“AMP-100”) in the U.S. and Canada.
Pursuant
to the Sintetica Agreement, the Company will pay Sintetica a per unit transfer price to supply AMP-100, along with a per unit royalty
for units sold. The Company is required to pay Sintetica up to $ 18,000,000 in one-time milestone payments including a $ 5,000,000 payment
(the “Upfront Payment”) due within 30 days of signing the Sintetica Agreement and the balance of payments due upon achievement
of certain regulatory and commercial milestones. Under the terms of the Sintetica Agreement, Sintetica will be responsible for regulatory
filings for AMP-100 in the U.S. The Upfront Payment along with an additional milestone payment of $ 3,117,000 was paid and recorded as
a R&D expenses during the year ended December 31, 2021. For the three months ended March 31, 2022, no amounts have been paid or accrued
under the Sintetica agreement.
Subject
to certain limitations, the term of the Sintetica Agreement is ten years, and allows for a ten-year extension if certain sales thresholds
are met.
Wakamoto
Agreement
In
August 2021, the Company entered into a License Agreement and a Basic Sale and Purchase Agreement (together, the “Wakamoto Agreements”)
with Wakamoto Pharmaceutical Co., Ltd. (“Wakamoto”), pursuant to which Wakamoto granted the Company the exclusive license
and marketing rights to its ophthalmic drug candidate (“MAQ-100”) in the U.S. and Canada.
Pursuant
to the Wakamoto Agreements, Wakamoto will supply MAQ-100 to the Company, and the Company
will pay Wakamoto a per unit transfer price to supply MAQ-100. In addition, the Company is required to pay Wakamoto various one-time
milestone payments totaling up to $ 2,000,000 upon the achievement of certain regulatory milestones and up to $ 6,200,000 upon the achievement
of certain commercial milestones. Under the terms of the Agreements, the Company will be responsible for regulatory filings and fees
for MAQ-100 in the U.S. and Canada. Through March 31, 2022, no amounts have been paid or accrued under the Wakamoto agreement.
Subject
to certain limitations, the term of the Agreements is for five years from the date of the FDA’s market approval of MAQ-100 and
allows for a five-year extension if certain unit sales thresholds are met.
Presbyopia
Asset Purchase Agreement – Related Party
In
December 2019, the Company entered into an asset purchase agreement (the “Presbyopia APA”) with Richard L. Lindstrom, M.D.,
a member of its Board of Directors. Pursuant to the terms of the Presbyopia APA, the Company acquired certain intellectual property and
related rights from Dr. Lindstrom to develop, formulate, make, sell, and sub-license an ophthalmic topical product to treat presbyopia
(the “Presbyopia Product”).
Under
the terms of the Presbyopia Product, the Company is required to make royalty payments to Dr. Lindstrom ranging from 2% to 4% of net sales,
dependent upon the final formulation and patent protection of the Presbyopia Product sold . Dr. Lindstrom was paid $ 0 in cash during the
periods ended March 31, 2022 and 2021, and was due $ 0 at March 31, 2022 and 2021. The Company incurred $ 0 for royalty expenses related
to the Presbyopia APA during the periods ended March 31, 2022 and 2021.
23
NOTE
16. CONCENTRATIONS
The
Company has two products that each comprised more than 10% of total revenues. These products collectively accounted for 32 %
and 36 %
of revenues during the three months ended March
31, 2022 and 2021, respectively.
The
Company sells its compounded formulations to a large number of customers. There were no customers who comprised more than 10% of the
Company’s total pharmacy sales during the three months ended March 31, 2022 and 2021.
The
Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 74 % and
82 % of active pharmaceutical ingredient purchases during the three months ended March 31, 2022 and 2021, respectively.
NOTE
17. SUBSEQUENT EVENTS
The
Company has performed an evaluation of events occurring subsequent to March 31, 2022 through the filing date of this Quarterly Report.
Based on its evaluation, no events other than those described below need to be disclosed.
Conditional
Melt Loan Amendment
In April 2022, the Company entered into a First Amendment (the “Amendment”) to its loan and security agreement previously
entered into on September 1, 2021 with Melt. The Amendment provides for:
●
Melt
is required to maintain a minimum cash balance of $7,000,000 for one (1) year following the effective date of the Amendment; and
a minimum cash balance of $5,000,000 at all times after the one year anniversary of the effective date of the Amendment .
●
The
maturity date by which all amounts owed under the loan agreement are payable was extended to September 1, 2026, unless otherwise
accelerated pursuant to the terms of the loan agreement.
●
The
definition of Material Adverse Effect was amended so that such an effect will be deemed to have occurred if the data from the phase
2 study of MELT-300 fails to demonstrate the benefit of the combination MELT-300 study drug versus the individual components of the
same MELT-300 study drug, as reasonably determined by the Company.
●
The
effectiveness of the Amendment is subject to, among other conditions, Melt consummating a qualifying financing of a minimum amount
of $ 15,000,000 from third party investors by August 31, 2022.
24
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.