Item 1. Financial Statements
Item 1. Financial Statements
HARROW HEALTH, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
March
31, 2021
December
31, 2020
(unaudited)
ASSETS
Current assets
Cash and cash equivalents, including restricted cash of $ 200
$ 6,504
$ 4,301
Investment in Eton Pharmaceuticals
25,620
28,455
Accounts receivable, net
3,253
2,662
Inventories
4,496
3,962
Prepaid expenses and other current assets
763
751
Total current assets
40,636
40,131
Property, plant and equipment, net
4,200
4,453
Operating lease right-of-use assets
6,651
6,799
Intangible assets, net
1,912
1,939
Investment in Surface Ophthalmics
465
1,314
Investment in Melt Pharmaceuticals
2,056
2,506
Goodwill
332
332
TOTAL ASSETS
$ 56,252
$ 57,474
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable and accrued expenses
$ 5,176
$ 3,932
Accrued payroll and related liabilities
1,631
2,315
Deferred revenue and customer deposits
3
66
Current portion of paycheck protection program loan payable
-
1,259
Current portion of loan payable, net of unamortized debt discount
2,659
2,639
Current portion of operating lease liabilities
597
580
Current portion of finance lease obligations
8
8
Total current liabilities
10,074
10,799
Operating lease liabilities, net of current portion
6,496
6,652
Finance lease obligations
16
17
Accrued expenses, net of current portion
800
800
Paycheck protection program loan payable, net of current portion
-
708
Loan payable, net of current portion and unamortized debt discount
10,996
11,670
TOTAL LIABILITIES
28,382
30,646
COMMITMENTS AND CONTINGENCIES
-
-
STOCKHOLDERS’ EQUITY
Common stock, $ 0.001 par value, 50,000,000 shares authorized, 25,983,676
and 25,749,875 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively
26
26
Additional paid-in capital
105,382
104,557
Accumulated deficit
( 77,183 )
( 77,400 )
TOTAL HARROW HEALTH STOCKHOLDERS’ EQUITY
28,225
27,183
Noncontrolling interests
( 355 )
( 355 )
TOTAL EQUITY
27,870
26,828
TOTAL LIABILITIES AND EQUITY
$ 56,252
$ 57,474
The accompanying notes are an integral part of these
unaudited condensed consolidated financial statements
3
HARROW HEALTH, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except for share and per share data)
For the Three Months Ended
For the Three Months Ended
March 31, 2021
March 31, 2020
Revenues:
Product sales, net
$
14,948
$
11,810
Other revenues
495
7
Total revenues
15,443
11,817
Cost of sales
( 3,770
)
( 3,626
)
Gross profit
11,673
8,191
Operating expenses:
Selling, general and administrative
8,164
8,416
Research and development
592
403
Total operating expenses
8,756
8,819
Income (loss) from operations
2,917
( 628
)
Other income (expense):
Interest expense, net
( 513
)
( 560
)
Investment loss from Melt Pharmaceuticals
( 470
)
( 546
)
Investment loss from Surface Ophthalmics
( 849
)
( 339
)
Investment loss from Eton Pharmaceuticals
( 2,835
)
( 10,850
)
Gain on forgiveness of debt
1,967
-
Total other (expense), net
( 2,700
)
( 12,295
)
Income (loss) before income taxes
217
( 12,923
)
Income taxes
-
-
Total net income (loss) including noncontrolling interests
217
( 12,923
)
Net loss attributable to noncontrolling interests
-
16
Net income (loss) attributable to Harrow Health, Inc.
$
217
$
( 12,907
)
Basic net income (loss) per share of common stock
$
0.01
$
( 0.50
)
Diluted net income (loss) per share of common stock
$
0.01
$
( 0.50
)
Weighted average number of shares of common stock outstanding, basic
26,019,255
25,867,568
Weighted average number of shares of common stock outstanding, diluted
27,480,622
25,867,568
The accompanying notes are an integral part of these
unaudited condensed consolidated financial statements
4
HARROW HEALTH, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
For the three months ended March 31, 2021 and 2020
(In thousands, except for share data)
Shares
Value
Capital
Deficit
Equity
Interest
Equity
Total
Common Stock
Additional
Harrow Health, Inc.
Total Noncontrolling
Par
Paid-in
Accumulated
Stockholders’
Equity
Total
Shares
Value
Capital
Deficit
Equity
Interest
Equity
Balance at December 31, 2019
25,526,931
$
26
$
101,728
$
( 74,043
)
$
27,711
$
( 293
)
$
27,418
Issuance of common stock in connection with:
Exercise of employee options
-
Issuance of common stock related to vesting of RSUs
91,987
-
-
-
-
-
-
Shares withheld related to net share settlement of equity awards
-
Stock-based compensation expense
-
-
533
-
533
-
533
Net loss
-
-
-
( 12,907
)
( 12,907
)
( 16
)
( 12,923
)
Balance at March 31, 2020
25,618,918
$
26
$
102,261
$
( 86,950
)
$
15,337
$
( 309
)
$
15,028
Balance at December 31, 2020
25,749,875
$
26
$
104,557
$
( 77,400
)
$
27,183
$
( 355
)
$
26,828
Issuance of common stock in connection with:
Exercise of employee options
11,301
-
27
-
27
-
27
Issuance of common stock related to vesting of RSUs
230,000
-
-
-
-
-
-
Shares withheld related to net share settlement of equity awards
( 7,500
)
-
( 57
)
-
( 57
)
-
( 57
)
Stock-based compensation expense
-
-
855
-
855
-
855
Net income
-
-
-
217
217
-
217
Balance at March 31, 2021
25,983,676
$
26
$
105,382
$
( 77,183
)
$
28,225
$
( 355
)
$
27,870
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
(In thousands)
For the
For the
Three Months
Ended
Three Months
Ended
March 31, 2021
March 31, 2020
CASH FLOWS FROM OPERATING ACTIVITIES
Net income (loss) (including noncontrolling interests)
$
217
$
( 12,923
)
Adjustments to reconcile net income (loss) to net cash provided by (used in)
operating activities:
Depreciation and amortization of property, plant and equipment
464
448
Amortization of intangible assets
40
45
Amortization of operating lease right-of-use assets
148
169
Provision for bad debt expense
19
-
Amortization of debt issuance costs and discount
96
160
Gain on forgiveness of debt
( 1,967
)
-
Investment loss from Eton Pharmaceuticals
2,835
10,850
Investment loss from Surface Ophthalmics
849
339
Investment loss from Melt Pharmaceuticals
470
546
Stock-based compensation
855
533
Changes in assets and liabilities:
Accounts receivable
( 610
)
( 20
)
Inventories
( 534
)
( 688
)
Prepaid expenses and other assets
( 32
)
( 8
)
Accounts payable and accrued expenses
1,105
( 337
)
Accrued payroll and related liabilities
( 684
)
333
Deferred revenue and customer deposits
( 63
)
3
NET CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES
3,208
( 550
)
CASH FLOWS FROM INVESTING ACTIVITIES
Investment in patent and trademark assets
( 13
)
( 53
)
Purchases of property, plant and equipment
( 211
)
( 220
)
NET CASH USED IN INVESTING ACTIVITIES
( 224
)
( 273
)
CASH FLOWS FROM FINANCING ACTIVITIES
Payments on finance lease obligations
( 1
)
( 2
)
Principal payments on SWK loan
( 750
)
-
Net proceeds from exercise of stock options, net of
taxes remitted upon vesting of RSU’s and options
( 30
)
-
NET CASH USED IN FINANCING ACTIVITIES
( 781
)
( 2
)
NET CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
2,203
( 825
)
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, beginning of period
4,301
4,949
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, end of period
$
6,504
$
4,124
RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH
Cash and cash equivalents
$
6,304
$
3,924
Restricted cash
200
200
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD
$
6,504
$
4,124
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for income taxes
$
-
$
-
Cash paid for interest
$
415
$
408
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Right-of-use asset obtained in exchange for lease obligation
$
-
$
41
Changes in accrued property and equipment purchases
$
-
$
5
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, 2021 and 2020
(All dollar amounts are expressed in thousands,
except share and per share data)
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”) 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 equity positions in Eton Pharmaceuticals, Inc. (“Eton”), Surface Ophthalmics, Inc. (“Surface”),
and Melt Pharmaceuticals, Inc. (“Melt”), all companies that began as subsidiaries of Harrow. In 2020, Harrow created
Visionology, Inc. (“Visionology”), which will launch an online eye health platform business. 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, 2021 are not necessarily indicative of the results that may
be expected for the year ending December 31, 2021 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, 2020.
The accompanying unaudited condensed consolidated
financial statements include the accounts of the Company and its wholly owned and majority-owned subsidiaries. All inter-company accounts
and transactions have been eliminated in consolidation.
Harrow consolidates entities in which it has a controlling
financial interest. The Company consolidates subsidiaries 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.
The condensed consolidated balance sheets
at March 31, 2021 and December 31, 2020 and the condensed consolidated statements of operations, stockholders’ equity and
cash flows for the periods ended March 31, 2021 and 2020 include our accounts and those of our wholly owned subsidiaries, as well
as our inactive majority owned subsidiaries Mayfield Pharmaceuticals, Inc. and Stowe Pharmaceuticals, Inc.
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The following represents an update for the three months
ended March 31, 2021 to the significant accounting policies described in the Company’s Annual Report on Form 10-K for the year ended
December 31, 2020.
Risks,
Uncertainties and Liquidity
The Company
is subject to certain regulatory standards, 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
The Company’s chief operating decision-maker
is its Chief Executive Officer who makes resource allocation decisions and assesses performance based on financial information of our
operating segments. The Company has identified two operating segments as reportable segments. See Note 16 for more information regarding
the Company’s reportable segments.
7
Noncontrolling Interests
The Company recognizes any noncontrolling interest
as a separate line item in equity in the condensed consolidated financial statements. A noncontrolling interest represents the portion
of equity ownership in a less-than-wholly-owned subsidiary not attributable to the Company. Generally, any interest that holds less than
50% of the outstanding voting shares is deemed to be a noncontrolling interest; however, there are other factors, such as decision-making
rights, that are considered as well. The Company includes the amount of net income (loss) attributable to noncontrolling interests in
consolidated net income (loss) on the face of the condensed consolidated statements of operations.
The Company provides in the condensed consolidated
statements of stockholders’ equity a reconciliation at the beginning and the end of the period of the carrying amount of total equity,
equity attributable to the parent, and equity attributable to the noncontrolling interest that separately discloses:
(1)
Net income or loss;
(2)
transactions with owners acting in their capacity as owners, showing separately contributions from and distributions to owners; and
(3)
each component of other income or loss.
Basic and Diluted Net Income (Loss) per Common
Share
Basic net income (loss) per common share is
computed by dividing net income (loss) attributable to common stockholders for the period by the weighted average number of common
shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) attributable
to common stockholders for the period by the weighted average number of common and common equivalent shares, such as stock options,
unvested restricted stock units (“RSUs”) and warrants, outstanding during the period.
Basic and diluted net income (loss) per share is computed
using the weighted average number of shares of common stock outstanding during the period. Common equivalent shares (using the treasury
stock or “if converted” method) from stock options, RSUs and warrants were
5,486,678 and 5,253,638 at March 31, 2021 and 2020, respectively. For the three months ended March 31, 2020, 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
income (loss) per share calculation were RSUs awarded to directors that had vested, but the issuance and delivery of the shares are deferred
until the director resigns. The number of shares underlying vested RSUs at March 31, 2021 and 2020 was 223,219 and 244,460 , respectively.
The following table shows the computation of basic
net income (loss) per share of common stock for the three months ended March 31, 2021 and 2020:
SCHEDULE OF BASIC EARNINGS PER COMMON SHARE
2021
2020
For the Three Months
Ended March 31,
2021
2020
Numerator – net income (loss) attributable to Harrow Health, Inc.
$
217
$
( 12,907
)
Denominator – weighted average number of shares outstanding, basic
26,019,255
25,867,568
Net income (loss) per share, basic
$
0.01
$
( 0.50
)
For the three months ended March 31, 2021, 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
March 31, 2021
Diluted shares related to:
Warrants
576,275
Stock options
885,092
Dilutive common equivalent shares
1,461,367
8
The following table shows the computation of diluted
net income (loss) per share using the weighted-average number of common shares and dilutive common equivalent shares outstanding for the
three months ended March 31, 2021 and 2020:
SCHEDULE OF DILUTED EARNINGS PER COMMON SHARE
2021
2020
For the Three Months
Ended March 31,
2021
2020
Numerator – net income (loss)
$
217
$
( 12,907
)
Weighted average number of shares outstanding, basic
26,019,255
25,867,568
Dilutive common equivalent shares
1,461,367
-
Denominator – number of shares used for diluted earnings per share computation
27,480,622
25,867,568
Net income (loss) per share, diluted
$
0.01
$
( 0.50
)
Investment in Eton Pharmaceuticals, Inc.
As of March 31, 2021, the Company owned 3,500,000
shares of Eton common stock, which represented approximately 14.3 % of the equity interests of Eton. At March 31, 2021, the fair market
value of Eton’s common stock was $ 7.32 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 loss from its Eton common stock position of $ 2,835 and $ 10,850 during the three months ended
March 31, 2021 and 2020, respectively, related to the change in fair market value of its investment in Eton during the measurement period.
As of March 31, 2021, the fair market value of the Company’s investment in Eton was $ 25,620 .
During the three months ended March 31, 2021, Mark
L. Baum, the Company’s Chief Executive Officer, resigned as a member of the board of directors of Eton. In April 2021, the Company
sold 1,518,000 shares of its Eton common stock (see Note 17 for more information related to this subsequent event). In light of these
events, the Company has determined that Eton is no longer a related party.
Investment in Melt Pharmaceuticals, Inc. –
Related Party
The Company owns 3,500,000 common shares (which is
approximately 44 % of the equity interests as of March 31, 2021) of Melt 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 Melt. 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. The Company’s share of earnings and losses are based on the Company’s
ownership interest of Melt. Any intra-entity profits and losses are eliminated. During the three months ended March 31, 2021 and 2020,
the Company recorded equity in the net losses of Melt of $ 470 and $ 546 , respectively. As of March 31, 2021 and December 31, 2020, the
Company’s investment in Melt was $ 2,056 and $ 2,506 , respectively, which includes $ 881 and $ 851 , respectively, due from Melt for
reimbursable expenses and amounts due under a Management Services Agreement between the Company and Melt (the “Melt MSA”).
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 (which is
approximately 30 % of the equity interests as of March 31, 2021) of Surface 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 condensed 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. The Company recorded equity in
the net losses of Surface of $ 849 and $ 339 during the three months ended March 31, 2021 and 2020, respectively. As of March 31, 2021 and
December 31, 2020, the Company’s investment in Surface was $ 465 and $ 1,314 , respectively.
See Note 5 for more information and related party
disclosure regarding Surface.
9
Recently Adopted Accounting Pronouncements
In December 2019, the FASB issued ASU 2019-12, Income
Taxes: Simplifying the Accounting for Income Taxes , which simplifies the accounting for income taxes. This guidance became effective
for the Company on January 1, 2021 on a prospective basis. Adoption of this ASU did not have a material impact on the Company’s
condensed consolidated financial statements.
NOTE 3. REVENUES
The Company accounts for contracts with customers
in accordance with ASC 606, Revenues from Contracts with Customers . The Company has three primary streams of revenue: (1) revenue
recognized from our sale of products within our pharmacy services, (2) revenue recognized from a commission agreement with a third party
and (3) revenue recognized from intellectual property license and asset purchase agreements.
Product Revenues from Pharmacy Services
The Company sells prescription drugs directly through
our pharmacy and outsourcing facility network. Revenue from our pharmacy services division includes: (i) the portion of the price the
client pays directly to us, net of any volume-related or other discounts paid back to the client, (ii) the price paid to us by individuals,
and (iii) customer copayments made directly to the pharmacy network. Sales taxes are not included in revenue. Following the core principle
of ASC 606, we have 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 meet the performance obligation, 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 our 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 pharmacy services division:
Revenues generated from prescription or office use
drugs sold by our pharmacies and outsourcing facility are recognized when the prescription is shipped. At the time of shipment, the pharmacy
services division 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.
Commission Revenues
During the year
ended December 31, 2020, the Company entered into an agreement whereby it is paid a fee calculated based on sales it 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 part of the Company
to recognize the associated revenue.
10
Intellectual Property License Revenues
As of March 31, 2021, we are party to four intellectual
property licenses and asset purchase agreements in which we have agreed to grant a license and which provide 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 at which 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, 2021 and 2020, consists of the following:
SCHEDULE OF DISAGGREGATED REVENUE
For the Three Months
Ended March 31,
2021
2020
Product sales, net
$
14,948
$
11,810
Commissions
485
-
Licenses
10
7
Total revenues
$
15,443
$
11,817
Deferred revenue and customer deposits at March 31,
2021 and December 31, 2020, were $ 3 and $ 66 , respectively. All deferred revenue and customer deposit amounts at December 31, 2020 were
recognized as revenue during the three months ended March 31, 2021.
NOTE
4. INVESTMENT IN 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 January and March 2019, the Company entered into
the Melt Series A Preferred Stock Agreement. See also Note 2, under the subheading Investment in Melt Pharmaceuticals, Inc.
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 .
As of March 31, 2021 and December 31, 2020, the Company
was due $ 881 and $ 851 , 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, 2021.
The Company’s Chief Executive Officer, Mark
L. Baum, and Chief Medical Officer, Larry Dillaha, M.D. are members of the Melt board of directors, and several employees of the Company
(including Mr. Baum, Dr. Dillaha and the Company’s Chief Financial Officer, Andrew R. Boll) entered into consulting agreements and
provide consulting services to Melt.
11
The unaudited condensed results of operations information
of Melt is summarized below:
SCHEDULE
OF CONDENSED INCOME STATEMENT
For the Three Months
Ended
March 31, 2021
March 31, 2020
Revenues, net
$
-
$
-
Loss from operations
( 1,099
)
( 1,235
)
Net loss
$
( 1,099
)
$
( 1,235
)
The unaudited condensed balance sheet information
of Melt is summarized below:
SCHEDULE OF CONDENSED BALANCE SHEET
At March 31,
At December 31,
2021
2020
Current assets
$
2,267
$
2,947
Non-current assets
79
11
Total assets
2,346
2,958
Total liabilities
2,133
1,778
Total stockholders equity
213
1,180
Total liabilities and stockholders’ equity
$
2,346
$
2,958
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, 2021, the Company owned 3,500,000
shares of Surface common stock (approximately 30 % of the 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. Surface is required to make royalty payments
to Dr. Lindstrom of 3 % of net sales of certain Surface products while certain patent rights remain outstanding. Dr. Lindstrom is also
a minority owner of Flying L Partners, an affiliate of the funding investor who purchased the Surface Series A Preferred Stock. Several
employees and a director of the Company (including Mr. Baum and Dr. Lindstrom) entered into consulting agreements and provide consulting
services to Surface.
The unaudited condensed results of operations information
of Surface is summarized below:
SUMMARY
OF CONDENSED INCOME STATEMENT
For the Three Months Ended
March 31, 2021
March 31, 2020
Revenues, net
$
-
$
-
Loss from operations
( 2,831
)
( 1,131
)
Net loss
$
( 2,831
)
$
( 1,131
)
The unaudited condensed balance sheet information
of Surface is summarized below:
SUMMARY
OF CONDENSED BALANCE SHEET
At March 31,
At December 31,
2021
2020
Current assets
$
6,013
$
9,074
Non current assets
44
45
Total assets
6,057
9,119
Total liabilities
1,328
1,666
Total stockholders equity
4,729
7,453
Total liabilities and stockholders’ equity
$
6,057
$
9,119
12
NOTE 6. RESTRICTED CASH
The restricted cash at March 31, 2021 and December
31, 2020 consisted of funds held in a money market account. At March 31, 2021 and December 31, 2020, the restricted cash was recorded
at amortized cost, which approximates fair value.
At March 31, 2021 and December 31, 2020, the funds
held in a money market account of $ 200 were classified as a current asset. The money market account funds are required as collateral as
additional security for the Company’s New Jersey facility lease.
NOTE 7. 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, 2021 and December 31, 2020 was as follows:
SCHEDULE
OF INVENTORIES
March 31, 2021
December 31, 2020
Raw materials
$
2,512
$
2,501
Work in progress
3
17
Finished goods
1,981
1,444
Total inventories
$
4,496
$
3,962
NOTE 8. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid expenses and other current assets at March
31, 2021 and December 31, 2020, consisted of the following:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
March 31, 2021
December 31, 2020
Prepaid insurance
$
171
$
160
Other prepaid expenses
399
401
Deposits and other current assets
193
190
Total prepaid expenses and other current assets
$
763
$
751
NOTE 9. PROPERTY,
PLANT AND EQUIPMENT
Property, plant and equipment at March 31, 2021 and
December 31, 2020, consisted of the following:
SCHEDULE
OF PROPERTY, PLANT AND EQUIPMENT
March 31, 2021
December 31, 2020
Property, plant and equipment, net:
Computer software and hardware
$
1,900
$
1,707
Furniture and equipment
422
418
Lab and pharmacy equipment
3,436
3,426
Leasehold improvements
5,725
5,720
Property, plant and equipment, gross
11,483
11,271
Accumulated depreciation and amortization
( 7,283
)
( 6,818
)
Property,
plant and equipment, net
$
4,200
$
4,453
For the three months ended March 31, 2021 and 2020,
depreciation and amortization related to the property, plant and equipment was $ 464 and $ 448 , respectively.
13
NOTE
10. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at March 31, 2021 consisted of the following:
SCHEDULE
OF INTANGIBLE ASSETS
Amortization
periods
(in years)
Cost
Accumulated amortization
Impairment
Net carrying value
Patents
17 - 19 years
$ 532
$ ( 54 )
$ -
$ 478
Licenses
20 years
50
( 6 )
-
44
Trademarks
Indefinite
357
-
-
357
Customer relationships
3 - 15 years
1,519
( 487 )
-
1,032
Trade name
5 years
5
( 5 )
-
-
Non-competition clause
3 - 4 years
50
( 50 )
-
-
State pharmacy licenses
25 years
8
( 7 )
-
1
$ 2,521
$ ( 609 )
$ -
$ 1,912
Amortization
expense for intangible assets for the three months ended March 31, 2021 and 2020 was as follows:
SCHEDULE
OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
For the Three Months Ended
March 31,
2021
2020
Patents
$ 6
$ 11
Licenses
1
1
Customer relationships
33
33
Trade name
-
-
State pharmacy licenses
-
-
$ 40
$ 45
Estimated
future amortization expense for the Company’s intangible assets at March 31, 2021 is as follows:
SCHEDULE
OF ESTIMATED FUTURE AMORTIZATION EXPENSE
2021
Remainder of 2021
$ 149
2022
188
2023
188
2024
161
2025
148
Thereafter
721
Intangible assets
$ 1,555
14
NOTE
11. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses consisted of the following:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
March
31, 2021
December
31, 2020
Accounts payable
$ 4,941
$ 3,645
Other accrued expenses
49
49
Accrued interest
186
238
Accrued exit fee for note payable
800
800
Total accounts payable and accrued expenses
5,976
4,732
Less: Current portion
( 5,176 )
( 3,932 )
Non-current total accrued expenses
$ 800
$ 800
NOTE
12. DEBT
SWK
Senior Note – 2017
In
July 2017, the Company and several of its wholly owned subsidiaries entered into a term loan and security agreement in the principal
amount of $ 16,000 (the “SWK Loan Agreement” or “SWK Loan”) with SWK Funding LLC and its partners (collectively,
“SWK”), as lender and collateral agent. The SWK Loan Agreement was fully funded at closing with a five-year term;
however, such term could be reduced to four years if certain revenue requirements were not achieved. The SWK Loan was
secured by substantially all of the Company’s assets, including its intellectual property rights. The SWK Loan was subsequently
amended in May 2019 and again in April 2020. The SWK Loan bore an interest rate that was equal to the three-month
London Inter-Bank Offered Rate (subject to a minimum of 2.00 %), plus an applicable margin of 10.00 % (the “Margin Rate”);
provided that, if, two days prior to a payment date, the Company provided SWK evidence that the Company has achieved a
leverage ratio as of such date of less than 4.00:1:00, the Margin Rate shall equal 9.00%; and if the Company has achieved a leverage
ratio as of such date of less than 3.00:1:00, the Margin Rate shall equal 7.00%. The leverage ratio means, as of any date of determination,
the ratio of: (a) indebtedness as of such date to (b) EBITDA (as defined in the SWK Loan), of the Company for the immediately
preceding 12-month period, adding-back (i) actual litigation expenses for the immediately preceding 12-month period,
minus (ii) actual litigation expenses for the immediately preceding 3 month period multiplied by four.
Subsequent to
March 31, 2021, the Company completed an offering of unsecured senior notes in the aggregate principal amount of $ 55,000 and used
a portion of the proceeds to pay off all outstanding obligations and indebtedness related to the SWK Loan (see Note 17 for additional
information).
Interest
expense related to the SWK Loan Agreement, as amended, amounted to $ 509 and $ 560 for the three months ended March 31, 2021 and
2020, respectively, and included amortization of debt issuance costs and discount of $ 96 and $ 160 for the three months
ended March 31, 2021 and 2020, respectively.
Paycheck
Protection Program Loan
In
April 2020, the Company entered into an unsecured promissory note and related Business Loan Agreement with Renasant Bank, as lender,
for a loan (the “PPP Loan”) in the principal amount of $ 1,967 and received cash proceeds of the same amount, pursuant to
the Paycheck Protection Program (the “PPP”) under the Federal Coronavirus Aid, Relief, and Economic Security Act (the “CARES
Act”), which was enacted March 27, 2020. The PPP is administered by the U.S. Small Business Administration (the “SBA”).
On March 30, 2021, the Company received a notice of forgiveness of the full balance of the PPP Loan, including all accrued interest,
in accordance with the terms and conditions of the CARES Act. Related to the forgiveness, the Company recorded a gain on the forgiveness
of debt for the loan balance of $ 1,967 in the accompanying condensed consolidated statement of operations for the period ended March
31, 2021.
15
At
March 31, 2021, future minimum payments under the Company’s debt were as follows:
SUMMARY
OF FUTURE MINIMUM PAYMENTS
Amount
Remainder of 2021
$ 3,395
2022
3,966
2023
9,511
Total minimum payments
16,872
Less: amount representing interest
( 2,511 )
Notes payable, gross
14,361
Less: unamortized discount
( 706 )
Notes payable
13,655
Less: current portion, net of unamortized discount
( 2,659 )
Note payable, net of current portion and unamortized debt discount
$ 10,996
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 four years and contain various clauses for renewal at the Company’s option.
●
An
operating lease for 10,200 square feet of office space in San Diego, California that expires in December 2021 , with an option to
extend the term for a five-year period ;
●
An
operating lease for 26,400 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
●
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 .
Future
lease payments under operating leases as of March 31, 2021 were as follows :
SCHEDULE OF FUTURE LEASE PAYMENTS UNDER OPERATING LEASES
Operating Leases
Remainder of 2021
$ 766
2022
1,038
2023
1,064
2024
1,090
2025
916
Thereafter
5,141
Total minimum lease payments
10,015
Less: amount representing interest payments
( 2,922 )
Total operating lease liabilities
7,093
Less: current portion, operating lease liabilities
( 597 )
Operating lease liabilities, net of current portion
$ 6,496
At
March 31, 2021, the weighted-average discount rate and the weighted-average remaining lease term for the operating leases held by the
Company were 6.33 % and 11.02 years, respectively.
During
the three months ended March 31, 2021 and 2020, cash paid for amounts included for the operating lease liabilities was $ 251 and $ 271 ,
respectively, and the Company recorded operating lease expense of $ 261 and $ 278 , respectively, included in selling, general and administrative
expenses.
The
Company also has a finance lease that is included in its lease accounting but is not considered significant.
16
Future
lease payments under the non-cancelable finance lease as of March 31, 2021 were as follows :
SCHEDULE OF FUTURE LEASE PAYMENTS UNDER FINANCE LEASE
Finance Leases
Remainder of 2021
$ 7
2022
9
2023
9
2024
1
Total minimum lease payments
26
Less: amount representing interest payments
( 2 )
Present value of future minimum lease payments
24
Less: current portion, finance lease obligation
( 8 )
Finance lease obligation, net of current portion
$ 16
At
March 31, 2021, the weighted average incremental borrowing rate and the weighted average remaining lease term for the finance lease held
by the Company were 6.36 % and 2.83 years, respectively.
For
the three months ended March 31, 2021, depreciation expense related to the equipment held under the finance lease obligation was $ 2 .
For
the three months ended March 31, 2021, cash paid and expense recognized for interest expense related to the finance lease obligation
was $ 1 .
NOTE
14. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Common
Stock
During
the three months ended March 31, 2021, the Company issued 11,301 shares of its common stock upon the exercise of options to purchase
11,301 shares of common stock, with exercise prices ranging between $ 1.70 to $ 3.96 per share and received net proceeds of $ 27 .
During
the three months ended March 31, 2021, the Company issued 200,000 shares of its common stock to Mark L. Baum, its CEO, related to the
vesting of 200,000 performance-based restricted stock units.
During
the three months ended March 31, 2021, the Company issued 22,500 shares of common stock to Andrew R. Boll, its CFO, related to the vesting
of 30,000 performance-based restricted stock units. The Company withheld issuance of 7,500 shares of common stock to Mr. Boll for payroll
tax purposes valued at $ 57 .
During
the three months ended March 31, 2021, 22,755 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 director resigns.
Preferred
Stock
At
March 31, 2021 and 2020, the Company had 5,000,000 shares of preferred stock, $ 0.001 par value, authorized and no shares of preferred
stock issued and outstanding.
Subsequent
to March 31, 2021, the Company sold 440,000 shares of Series B Cumulative Preferred Stock for gross proceeds of $ 11,000 (see Note 17
for additional information).
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 (the “2017 Plan” together with the 2007 Plan, the “Plans”). As of March
31, 2021, the 2017 Plan provides for the issuance of a maximum of 2,000,000 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, 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 4,077 shares available for future issuances under the 2017 Plan
at March 31, 2021.
17
Stock
Options
A
summary of stock option activity under the Plans for the three months ended March 31, 2021 is as follows:
SCHEDULE OF STOCK OPTION PLAN ACTIVITY
Number of Shares
Weighted Avg. Exercise Price
Weighted Avg. Remaining Contractual Life
Aggregate Intrinsic Value
Options outstanding - January 1, 2021
3,030,033
$ 5.43
Options granted
67,000
$ 8.07
Options exercised
( 11,301 )
$ 2.42
Options cancelled/forfeited
( 28,195 )
$ 5.45
Options outstanding - March 31, 2021
3,057,537
$ 5.50
5.54
$ 5,287
Options exercisable
2,169,441
$ 4.85
5.04
$ 4,944
Options vested and expected to vest
2,968,979
$ 5.45
5.50
$ 5,254
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 options with an exercise price lower
than the market price on March 31, 2021, based on the closing price of the Company’s common stock of $ 6.75 on that date.
During
the three months ended March 31, 2021, 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
and consultants during the three months ended March 31, 2021 were as follows: 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
2021
Weighted-average fair value of options granted
$ 4.96
Expected terms (in years)
6.11
Expected volatility
69 %
Risk-free interest rate
0.39 - 0.45 %
Dividend yield
-
18
The
following table summarizes information about stock options outstanding and exercisable at March 31, 2021:
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 - $ 2.60
760,318
5.38
$ 2.06
750,557
$ 2.06
$ 2.76 - $ 4.66
513,628
5.51
$ 3.98
442,498
$ 3.97
$ 5.49 - $ 6.36
470,350
6.84
$ 6.12
320,023
$ 6.13
$ 6.64 - $ 8.99
1,313,241
5.18
$ 7.86
656,363
$ 7.99
$ 1.47 - $ 8.99
3,057,537
5.54
$ 5.50
2,169,441
$ 4.85
As
of March 31, 2021, there was approximately $ 2,582 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 4.59 years. The stock-based
compensation for all stock options was $ 452 and $ 263 during the three months ended March 31, 2021 and 2020, respectively.
The
intrinsic value of options exercised during the three months ended March 31, 2021 was $ 63 .
Restricted
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.
During
the three months ended March 31, 2021, 300,000 RSUs with a fair market value of $ 2,670 were issued to certain employees; the RSUs vest
in full on the third anniversary of the grant date.
A
summary of the Company’s RSU activity and related information for the three months ended March 31, 2021 is as follows:
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY
Number of RSUs
Weighted Average Grant Date Fair Value
RSUs unvested - January 1, 2021
1,601,509
$ 3.14
RSUs granted
300,000
$ 8.90
RSUs vested
( 252,755 )
$ 2.38
RSUs cancelled/forfeited
-
-
RSUs unvested at March 31, 2021
1,648,754
$ 4.30
As
of March 31, 2021, the total unrecognized compensation expense related to unvested RSUs was approximately $ 3,687 , which is expected to
be recognized over a weighted-average period of 0.82 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, 2021 and 2020 was $ 346 and $ 259 , 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.
19
A
summary of warrant activity for the three months ended March 31, 2021 is as follows:
SCHEDULE OF WARRANTS ACTIVITY
Number of Shares Subject to Warrants Outstanding
Weighted Avg. Exercise Price
Warrants outstanding - January 1, 2021
780,386
$ 2.12
Granted
-
-
Exercised
-
-
Expired
-
-
Warrants outstanding and exercisable - March 31, 2021
780,386
$ 2.12
Weighted average remaining contractual life of the outstanding warrants in years - March 31, 2021
3.28
Warrants
outstanding and exercisable as of March 31, 2021 are as follows:
SCHEDULE OF WARRANTS OUTSTANDING AND WARRANTS EXERCISABLE
Warrant Series
Issue Date
Warrants
Outstanding
Exercise
Price
Expiration
Date
Lender warrants
5/11/2015
125,000
$ 1.79
5/11/2025
Settlement warrants
8/16/2016
40,000
$ 3.75
8/16/2021
Lender warrants
7/19/2017
615,386
$ 2.08
7/19/2024
780,386
$ 2.12
Subsidiary
Stock-Based Transactions
The
Company recognized $57 in stock-based compensation expense related to subsidiary stock options during the three months ended March 31,
2021.
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,
2021
2020
Employees - selling, general and administrative
$ 755
$ 436
Directors - selling, general and administrative
100
97
Total
$ 855
$ 533
NOTE
15. COMMITMENTS AND CONTINGENCIES
Legal
Novel
Drug Solutions et al.
In
April 2018, Novel Drug Solutions, LLC and Eyecare Northwest, PA (collectively “NDS”) filed a lawsuit against the Company
in the U.S. District Court of Delaware asserting claims for breach of contract. The claims stem from an asset purchase agreement between
the Company and NDS entered into in 2013. In July 2019, NDS filed a second amended complaint which added a claim related to its purported
termination of the APA. In October 2019, NDS voluntarily dismissed all claims related to breach of contract, leaving only claims related
to the scope of the post-termination obligations to be litigated. On October 29, 2020, at a hearing on the various dispositive motions
before it, the Court found that there were triable issues of fact and reopened discovery for limited purposes. NDS is seeking unspecified
damages, interest, attorney’s fees and other costs. The Company believes the claims are meritless and has previously and will continue
to dispute all claims asserted against it and intends to vigorously defend against these allegations. Nonetheless, the Company cannot
predict the eventual outcome of this litigation and it could result in substantial costs, losses and a diversion of management’s
resources and attention, which could harm the Company’s business and the value of its common stock.
20
Product
and Professional Liability
Product
and professional liability litigation represents an inherent risk to all firms in the pharmaceutical and pharmacy industry. We utilize
traditional third-party insurance policies with regard to our product and professional liability claims. Such insurance coverage at any
given time reflects current market conditions, including cost and availability, when the policy is written.
John
Erick et al.
In
January 2018, John Erick and Deborah Ferrell, successors-in-interest and heirs of Jade Erick, (collectively “Erick”) filed
a lawsuit in the San Diego County Superior against Kim Kelly, ND, MPH asserting claims related to the death of Jade Erick. In April 2018,
Erick filed an amendment to the lawsuit, naming us as a co-defendant. In September 2018, co-defendant Dr. Kelly filed a cross-complaint
against the Company and various entities affiliated with Spectrum Laboratory Products, Inc., Spectrum Chemical Manufacturing Corp. and
Spectrum Pharmacy Products, Inc. (collectively “Spectrum”). The cross-complaint seeks indemnity and contribution from the
Company and Spectrum. The Company answered the claims filed by Dr. Kelly in October 2018. The case is currently in the discovery phase.
Erick is seeking unspecified damages, interest, attorney’s fees and other costs. The Company believes the claims are meritless
and has previously and will continue to dispute all claims asserted against it and intends to vigorously defend against these allegations.
Nonetheless, the Company cannot predict the eventual outcome of this litigation, it could result in substantial costs, losses and a diversion
of management’s resources and attention, which could harm the Company’s business and the value of its common stock.
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.
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 and 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 is required to make certain milestone
payments to Dr. Lindstrom including: (i) an initial payment of $ 50 upon execution of the Klarity License Agreement, (ii) a second payment
of $ 50 following the first $ 50 in net sales of the Klarity Product; and (iii) a final payment of $ 50 following the first $ 100 in net
sales of the Klarity Product. All of the above referenced milestone payments are payable at the Company’s election in cash or shares
of the Company’s restricted common stock. Payments totaling $ 35 and $ 55 were made during the three months ended March 31, 2021
and 2020, respectively. $ 35 and $ 29 was incurred as royalty expense during the three months ended March 31, 2021 and 2020, respectively,
and 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 upon execution of the Lindstrom APA. Dr. Lindstrom was
paid $ 7 and $ 7 in cash during the three months ended March 31, 2021 and 2020, respectively. The Company incurred $ 7 and $ 38 for royalty
expenses related to the Lindstrom APA during the three months ended March 31, 2021 and 2020.
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.
Subject
to early termination, the Dexycu Agreement expires on August 1, 2025, subject to specified
notice periods and specified limitations, either party may terminate the Dexycu Agreement
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, 2021,
the Company recorded $ 485 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, as applicable. $ 0 and $ 83 of stock-based payments were recorded and $ 804 and $ 603 were
incurred under these agreements for commission expenses during the three months ended March 31, 2021 and 2020, 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. $ 232 and $ 144 were incurred under these agreements as royalty expenses and included in accounts payable at March 31, 2021
and 2020, respectively.
NOTE
16. SEGMENT INFORMATION AND CONCENTRATIONS
Management
evaluates performance of the Company based on operating segments. Segment performance for its two operating segments is based on segment
contribution. The Company’s reportable segments consist of (i) its commercial stage pharmaceutical business known as ImprimisRx;
and (ii) its start-up operations associated with pharmaceutical drug development business (Pharmaceutical Drug Development). Segment
contribution for the segments represents net revenues less cost of sales, research and development, selling and marketing expenses, and
select general and administrative expenses. The Company does not evaluate the following items at the segment level:
●
Selling,
general and administrative expenses that result from shared infrastructure, including certain expenses associated with legal matters,
public company costs (e.g. investor relations), board of directors and principal executive officers and other like shared expenses.
●
Operating
expenses within selling, general and administrative expenses that result from the impact of corporate initiatives. Corporate initiatives
primarily include integration, restructuring, acquisition and other shared costs.
●
Other
select revenues and operating expenses including R&D expenses, amortization, and asset sales and impairments, net as not all
such information has been accounted for at the segment level, or such information has not been used by all segments.
●
Total
assets including capital expenditures.
The
Company defines segment net revenues as pharmaceutical compounded drug sales, licenses, commissions and other revenue derived from related
agreements.
Cost
of sales within segment contribution includes direct and indirect costs to manufacture formulations and sell products, including active
pharmaceutical ingredients, personnel costs, packaging, storage, royalties, shipping and handling costs, manufacturing equipment and
tenant improvements depreciation, the write-off of obsolete inventory and other related expenses.
Selling,
general and administrative expenses consist mainly of personnel-related costs, marketing and promotion costs, distribution costs, professional
service costs, insurance, depreciation, facilities costs, transaction costs, and professional services costs which are general in nature
and attributable to the segment.
23
Segment
net revenues, segment operating expenses and segment contribution information consisted of the following for the three months ended March
31, 2021:
SCHEDULE OF SEGMENT NET REVENUES, SEGMENT OPERATING EXPENSES AND SEGMENT CONTRIBUTION
For the Three Months Ended
March 31, 2021
ImprimisRx
Pharmaceutical Drug Development
Total
Net revenues
$ 15,443
$ -
$ 15,443
Cost of sales
( 3,770 )
-
( 3,770 )
Gross profit
11,673
-
11,673
Operating expenses:
Selling, general and administrative
5,771
-
5,771
Research and development
210
13
223
Segment contribution
5,692
( 13 )
5,679
Corporate
2,353
Research and development
369
Amortization
40
Operating income
$ 2,917
For the Three Months Ended
March 31, 2020
ImprimisRx
Pharmaceutical Drug Development
Total
Net revenues
$ 11,817
$ -
$ 11,817
Cost of sales
( 3,626 )
-
( 3,626 )
Gross profit
8,191
-
8,191
Operating expenses:
Selling, general and administrative
6,640
44
6,684
Research and development
43
11
54
Segment contribution
1,508
( 55 )
1,453
Corporate
1,687
Research and development
349
Amortization
45
Operating loss
$ ( 628 )
The
Company categorizes revenues by geographic area based on selling location. All operations are currently located in the U.S.; therefore,
total revenues are attributed to the U.S. All long-lived assets at March 31, 2021 and December 31, 2020 were located in the U.S.
Concentrations
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 for the three months ended March 31, 2021 and 2020.
The Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 82 %
and 78 % of active pharmaceutical ingredient purchases during the three months ended March 31, 2021 and 2020, respectively.
NOTE
17. SUBSEQUENT EVENTS
The
Company has performed an evaluation of events occurring subsequent to March 31, 2021 through the filing date of this Quarterly Report.
Based on its evaluation, no events other than those described below need to be disclosed.
Vesting
and Exercise of Equity Awards
In
April 2021, the Company issued 515,871 shares of its common stock to Mark L. Baum, its Chief Executive Officer, upon the vesting of 850,000
performance-based restricted stock units. The Company withheld issuance of 334,129 shares of common stock valued at $ 2,760 for payroll
tax purposes.
24
In
April 2021, the Company issued 77,668 shares of common stock to Andrew R. Boll, its Chief Financial Officer, upon the vesting of 127,500
performance-based restricted stock units. The Company withheld issuance of 49,832 shares of common stock valued at $ 411 for payroll tax
purposes.
In
April 2021, the Company issued 5,000 shares of its common stock upon the exercise of options to purchase 5,000 shares of common stock,
with an exercise price of $ 4.29 per share, and received net proceeds of $ 21 .
Sale
of Eton Stock
In April 2021, the Company closed the underwritten public offering of 1,518,000 shares of its Eton common stock at a public offering
price of $ 7.00 per share (the “Eton Stock Sale”). The gross proceeds to the Company from the Eton Stock Sale were $ 10,626 ,
before deducting underwriting discounts and commissions and other offering expenses payable by the Company. Following such sale, the
Company owns 1,982,000 shares of Eton common stock, which represented approximately 8.1 % of the equity and voting interests issued and
outstanding of Eton as of April 12, 2021.
As
part of the Eton Stock Sale, the Company also agreed, for a period of 180 days, not to conduct any further sales of shares of its common
stock of Eton or otherwise dispose of, directly or indirectly, any common stock of Eton (or any securities convertible into, or exercisable
or exchangeable for, the common stock of Eton).
8.625%
Senior Notes Due 2026
In
April 2021, we closed an offering of $ 50,000 aggregate principal amount of 8.625 % Senior Notes due 2026 (the
“Notes”) and in May 2021, the underwriters exercised their option to purchase an additional $ 5,000 aggregate
principal amount of the Notes ($ 55,000 in total). T he 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 the 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 . 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.
SWK
Loan Repayment
In
April 2021, the Company paid $ 15,540 related to all outstanding obligations to SWK under the SWK Loan, including outstanding principal,
accrued interest, accrued exit fee and related expenses.
Series
B Cumulative Preferred Stock
In
May 2021, the Company issued 440,000
shares of the Company’s Series B
Cumulative Preferred Stock, par value $ 0.001
per share and liquidation preference of
$ 25.00
per share (the “Series B Preferred
Stock”), for a net purchase price of approximately $ 10,670 .
The Series B Preferred Stock is not convertible into our common stock, has no voting rights, except as required by Delaware law,
and is redeemable by the Company at any time. Holders of Series B Preferred Stock, when and as authorized by the
Company’s Board of Directors, are entitled to cumulative cash dividends at the rate of 9.50 % of the $25.00 liquidation preference per year (equivalent to $2.375 per share per year); provided, however, that for each thirty
(30) day period following May 5, 2021, the dividend rate shall be increased in increments of fifty (50) basis points, and effective
September 30, 2021, the dividend rate shall be set at 12%, and for each thirty (30) day period thereafter, the dividend rate shall
be increased in increments of one hundred (100) basis points except as otherwise limited by applicable law. Dividends will be
payable quarterly in arrears, on or about the 15th of January, April, July and October, beginning on or about July 15, 2021. In the event of any liquidation, dissolution or winding-up of the Company, the holders of the Series B Preferred Stock will have
preference to holders of our common stock at $ 25.00 per share plus any accrued and unpaid dividends (whether or not authorized
or declared).
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Mayfield
Pharmaceuticals MAY-66 License Termination
In
May 2021, Mayfield terminated the License Agreement (the “TGV License”) with TGV-Health, LLC and affiliated entities (collectively,
“TGV”), pursuant to which it acquired intellectual property rights for use in the women’s health field, related to
Mayfield’s proprietary drug candidate MAY-66. Concurrent with the termination, TGV returned to Mayfield 300,000 shares of Mayfield’s
common stock, constituting all of the equity held by TGV. Mayfield has no outstanding or remaining obligations under the TGV License.
Mayfield
Pharmaceuticals MAY-44 APA Termination
In
May 2021, Mayfield and Harrow terminated their asset purchase agreement dated January 2020 for intellectual property rights associated
with Mayfield’s drug candidate MAY-44 with Elle Pharmaceutical LLC (the “MAY-44 APA”). As part of the termination,
Mayfield re-acquired 350,000 shares of its common stock from Elle. Mayfield has no outstanding or remaining obligations related to the
MAY-44 APA.
Stowe
License Termination
In
May 2021, Stowe terminated the License Agreement (the “Stowe License”) with TGV, pursuant to which it acquired intellectual
property rights for use in the ophthalmic field, related to Stowe’s proprietary drug candidate STE-006. Concurrent with the termination,
TGV returned to Stowe 1,750,000 shares of Stowe’s common stock, constituting all of the equity held by TGV. Stowe has no outstanding
or remaining obligations under the Stowe License.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.