Item 9A. Controls and Procedures
ITEM
9A. CONTROLS AND PROCEDURES
Disclosure
Controls and Procedures
Our
management, under the supervision and with the participation of our Chief Executive Officer (“CEO”), our principal executive
officer, and our Chief Financial Officer (“CFO”), our principal financial and accounting officer, conducted an evaluation
of the effectiveness of our disclosure controls and procedures as of December 31, 2023, the end of the period covered by this Annual
Report, pursuant to Rules 13a-15(b) and 15d-15(b) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
In
connection with that evaluation, our CEO and CFO concluded that, as of December 31, 2023, our disclosure controls and procedures were
effective. For the purpose of this review, disclosure controls and procedures means controls and procedures designed to ensure that information
required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in the SEC’s rules and forms. These disclosure controls and procedures include, without limitation,
controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under
the Exchange Act is accumulated and communicated to management, including our principal executive officer, principal financial officer
and principal accounting officer, as appropriate to allow timely decisions regarding required disclosure.
Management’s
Annual Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rules 13a-15(f)
and 15d-15(f) under the Exchange Act. Internal control over financial reporting is a process designed by, or under the supervision of,
our CEO and CFO and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted
accounting principles. Our management, under the supervision and with the participation of our CEO and CFO, conducted an evaluation of
the effectiveness of our internal control over financial reporting based on the framework in Internal Control — Integrated Framework
(2013) issued by the Committee of Sponsoring Organizations. Based on such evaluation, management concluded that our internal control
over financial reporting was effective as of December 31, 2023.
This
Annual Report does not include an attestation report of our independent registered public accounting firm regarding internal control
over financial reporting, in accordance with applicable SEC rules that permit us to provide only management’s report in the annual
report.
Changes
in Internal Control over Financial Reporting
There
has been no change in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during the
year ended December 31, 2023, that has materially affected, or is reasonably likely to materially affect our internal control over financial
reporting.
67
Inherent
Limitations on Effectiveness of Controls
Our
management, including our CEO and CFO, do not expect that our disclosure controls or our internal control over financial reporting will
prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable,
not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact
that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the
inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error
or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. These inherent limitations include
the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Controls
can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the
controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there
can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of
any evaluation of controls effectiveness to future periods are subject to risks. Over time, controls may become inadequate because of
changes in conditions or deterioration in the degree of compliance with policies or procedures.
ITEM
9B. OTHER INFORMATION
None.
ITEM
9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not
applicable.
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The
information required by this item is incorporated by reference to the information set forth under the captions “Election of Directors,”
“Executive Officers,” “Corporate Governance,” “Corporate Governance — Delinquent Section 16(a) Reports,”
and “Corporate Governance — Code of Business Conduct and Ethics” in the Company’s Proxy Statement for the 2024
Annual Meeting of Stockholders.
ITEM
11. EXECUTIVE COMPENSATION
The
information required by this item is incorporated by reference to the information set forth under the captions “Executive Compensation”
and “Director Compensation” in the Company’s Proxy Statement for the 2024 Annual Meeting of Stockholders.
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The
information required by this item is incorporated by reference to the information set forth under the captions “Security Ownership
of Certain Beneficial Owners and Management and Related Stockholder Matters” and “Executive Compensation — Securities
Authorized for Issuance Under Equity Compensation Plans” in the Company’s Proxy Statement for the 2024 Annual Meeting of
Stockholders.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The
information required by this item is incorporated by reference to the information set forth under the captions “Corporate Governance
— Transactions with Related Persons” and “Corporate Governance — Director Independence” in the Company’s
Proxy Statement for the 2024 Annual Meeting of Stockholders.
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The
information required by this item is incorporated by reference to the information set forth under the caption “Ratification of
Selection of Independent Registered Public Accounting Firm” in the Company’s Proxy Statement for the 2024 Annual Meeting
of Stockholders.
68
PART
IV
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)
List
of the following documents filed as part of the report:
(1)
See
the index to our consolidated financial statements on page F-1 for a list of the financial statements being filed in this Annual
Report.
(2)
All
financial statement schedules are omitted because they are not applicable or the required information is shown in the consolidated
financial statements or the notes thereto.
(3)
See
Item 15(b) below for all exhibits being filed or incorporated by reference herein.
(b)
Exhibits:
EXHIBIT
INDEX
Exhibit
No.
Description
2.1
Agreement and Plan of Merger, dated as of September 17, 2007, by and among Imprimis Pharmaceuticals, Inc., Transdel Pharmaceuticals Holdings, Inc. and Trans-Pharma Acquisition Corp. Incorporation (incorporated herein by reference to Exhibit 2.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on September 21, 2007).
3.1
Amended and Restated Certificate of Incorporation, as amended (incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of Harrow, Inc. filed with the Securities and Exchange Commission on September 29, 2023).
3.2
Amended and Restated Bylaws of Harrow, Inc. (incorporated herein by reference to Exhibit 3.2 to the Current Report on Form 8-K of Harrow, Inc. filed with the Securities and Exchange Commission on September 29, 2023).
4.1*
Description of the Company’s Securities
4.2
Indenture dated April 20, 2021, between Harrow, Inc. and U.S. Bank National Association, as Trustee (incorporated herein by reference to Exhibit 4.1 to the Current Report on Form 8-K of Harrow, Inc. filed with the Securities and Exchange Commission on April 20, 2021).
4.3
First Supplemental Indenture dated April 20, 2021 between Harrow, Inc. and U.S. Bank National Association, as Trustee (incorporated herein by reference to Exhibit 4.2 to the Current Report on Form 8-K of Harrow, Inc. filed with the Securities and Exchange Commission on April 20, 2021).
4.4
Form of 8.625% Senior Note due 2026 (incorporated herein by reference to Exhibit 4.3 to the Current Report on Form 8-K of Harrow, Inc. filed with the Securities and Exchange Commission on April 20, 2021).
4.5
Second Supplemental Indenture dated December 20, 2022 between Harrow, Inc. and U.S. Bank Trust Company, National Association (incorporated herein by reference to Exhibit 4.2 to the Current Report on Form 8-K of Harrow, Inc. filed with the Securities and Exchange Commission on December 20, 2022).
4.6
Form of 11.875% Senior Note due 2027 (incorporated herein by reference to Exhibit 4.3 to the Current Report on Form 8-K of Harrow, Inc. filed with the Securities and Exchange Commission on December 20, 2022).
10.1
Form of Directors and Officers Indemnification Agreement (incorporated herein by reference to Exhibit 10.8 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on September 21, 2007)
10.2#
Imprimis Pharmaceuticals, Inc. Amended and Restated 2007 Stock Incentive and Awards Plan (incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on May 8, 2013)
69
10.3#
Amendment No. 1 to Imprimis Pharmaceuticals, Inc. Amended and Restated 2007 Incentive Stock and Awards Plan (incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on November 6, 2013)
10.4#
Form of Incentive Stock Option Agreement (incorporated herein by reference to Exhibit 10.12 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on September 21, 2007)
10.5#
Form of Non-Qualified Stock Option Agreement (incorporated herein by reference to Exhibit 10.13 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on September 21, 2007)
10.6#
Form of Restricted Stock Unit Agreement (incorporated herein by reference to Exhibit 10.4 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on May 8, 2013)
10.7#
Employment Agreement, dated as of April 25, 2016, by and between Imprimis Pharmaceuticals, Inc. and Mark L. Baum (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 26, 2016)
10.8#
Employment Agreement, dated as of April 25, 2016, by and between Imprimis Pharmaceuticals, Inc. and Andrew R. Boll (incorporated herein by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 26, 2016)
10.9#
Employment Agreement, dated as of April 25, 2016, by and between Imprimis Pharmaceuticals, Inc. and John P. Saharek (incorporated herein by reference to Exhibit 10.7 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 26, 2016)
10.10
License Agreement dated April 1, 2017 between Imprimis Pharmaceuticals, Inc. and Richard L. Lindstrom, M.D. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on April 6, 2017)
10.11#
Consulting Agreement dated May 1, 2017 between Eton Pharmaceuticals, Inc. and Mark L. Baum (incorporated herein by reference to Exhibit 10.8 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on August 10, 2017)
10.12#
Consulting Agreement dated May 1, 2017 between Eton Pharmaceuticals, Inc. and Andrew R. Boll (incorporated herein by reference to Exhibit 10.9 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on August 10, 2017)
10.13#
Consulting Agreement dated May 1, 2017 between Eton Pharmaceuticals, Inc. and John P. Saharek (incorporated herein by reference to Exhibit 10.10 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on August 10, 2017)
10.14#
Consulting Agreement dated October 27, 2017 between Surface Pharmaceuticals, Inc. and Mark L. Baum (incorporated herein by reference to Exhibit 10.53 to the Annual Report on Form 10-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on March 8, 2017)
10.15#
Consulting Agreement dated October 27, 2017 between Surface Pharmaceuticals, Inc. and Andrew R. Boll (incorporated herein by reference to Exhibit 10.54 to the Annual Report on Form 10-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on March 8, 2017)
10.16#
Consulting Agreement dated October 27, 2017 between Surface Pharmaceuticals, Inc. and John P. Saharek (incorporated herein by reference to Exhibit 10.55 to the Annual Report on Form 10-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on March 8, 2017)
70
10.17
Asset Purchase and License Agreement dated September 28, 2017 between Imprimis Pharmaceuticals, Inc. and Surface Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on May 15, 2018)
10.18
Amended and Restated Asset Purchase and License Agreement dated April 10, 2018 between Imprimis Pharmaceuticals, Inc. and Surface Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.2 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on May 15, 2018)
10.19
Amended and Restated License Agreement dated April 10, 2018 between Imprimis Pharmaceuticals, Inc. and Richard L. Lindstrom, M.D. (incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on August 6, 2018)
10.20
Consulting Agreement dated March 1, 2018 between Surface Pharmaceuticals, Inc. and Richard L. Lindstrom, M.D. (incorporated herein by reference to Exhibit 10.4 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on August 6, 2018)
10.21#
Consulting Agreement dated May 1, 2018 between Melt Pharmaceuticals, Inc. and Mark L. Baum (incorporated herein by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on November 13, 2018)
10.22#
Consulting Agreement dated May 1, 2018 between Melt Pharmaceuticals, Inc. and Andrew R. Boll (incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on November 13, 2018)
10.23#
Consulting Agreement dated May 1, 2018 between Melt Pharmaceuticals, Inc. and John P. Saharek (incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on November 13, 2018)
10.24
Asset Purchase Agreement dated December 11, 2018 between Harrow, Inc. (fka Imprimis Pharmaceuticals, Inc.) and Melt Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Harrow, Inc. filed with the Securities and Exchange Commission on February 5, 2019)
10.25#
Consulting Agreement dated June 3, 2019 between Mayfield Pharmaceuticals, Inc. and Mark L. Baum (incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of Harrow, Inc. filed with the Securities and Exchange Commission on August 14, 2019)
10.26#
Consulting Agreement dated June 3, 2019 between Mayfield Pharmaceuticals, Inc. and Andrew R. Boll (incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of Harrow, Inc. filed with the Securities and Exchange Commission on August 14, 2019)
10.27#
Consulting Agreement dated June 3, 2019 between Mayfield Pharmaceuticals, Inc. and John P. Saharek (incorporated herein by reference to Exhibit 10.4 to the Quarterly Report on Form 10-Q of Harrow, Inc. filed with the Securities and Exchange Commission on August 14, 2019)
10.28#
Consulting Agreement dated February 13, 2020 between Stowe Pharmaceuticals, Inc. and Mark L. Baum (incorporated herein by reference to Exhibit 10.64#* to the Annual Report on Form 10-K of Harrow, Inc. filed with the Securities and Exchange Commission on March 13, 2020).
10.29#
Consulting Agreement dated February 13, 2020 between Stowe Pharmaceuticals, Inc. and Andrew R. Boll (incorporated herein by reference to Exhibit 10.65#* to the Annual Report on Form 10-K of Harrow, Inc. filed with the Securities and Exchange Commission on March 13, 2020).
10.30#
Consulting Agreement dated February 13, 2020 between Stowe Pharmaceuticals, Inc. and John P. Saharek (incorporated herein by reference to Exhibit 10.66#* to the Annual Report on Form 10-K of Harrow, Inc. filed with the Securities and Exchange Commission on March 13, 2020).
10.31
Commercial Alliance Agreement between Eyepoint Pharmaceuticals, Inc. and ImprimisRx, LLC dated August 1, 2020 (incorporated herein by reference to Exhibit 10.1*# to the Quarterly Report on Form 10-Q of Harrow, Inc. filed with the Securities and Exchange Commission on November 9, 2020).
10.32
Expansion Term Letter Agreement dated December 6, 2021 between Eyepoint Pharmaceuticals, Inc. and ImprimisRx, LLC (incorporated herein by reference to Exhibit 10.50 to the Annual Report on Form 10-K of Harrow, Inc. filed with the Securities and Exchange Commission on March 10, 2022)
71
10.33
Mutual Termination Agreement dated October 7, 2022 between ImprimisRx and EyePoint Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of Harrow, Inc. filed with the Securities and Exchange Commission on November 14, 2022)
10.34
License and Supply Agreement dated July 25, 2021 between Harrow, Inc. and Sintetica, S.A. (incorporated herein by reference to Exhibit 10.2 to the Current Report on Form 10-Q of Harrow, Inc. filed with the Securities and Exchange Commission on August 10, 2021)
10.35#
Harrow, Inc. 2017 Incentive Stock and Awards Plan (incorporated herein by reference to Exhibit 10.1 to the Registration Statement on Form S-8 of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on August 25, 2017)
10.36#
First Amendment to the Harrow, Inc. 2017 Incentive Stock and Awards Plan (incorporated herein by reference to Appendix A to Harrow, Inc.’s Definitive Proxy Statement filed with the Securities and Exchange Commission on April 23, 2021)
10.37
Loan and Security Agreement dated September 1, 2021 among Harrow, Inc. and Melt Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Harrow, Inc. filed with the Securities and Exchange Commission on September 2, 2021)
10.38
First Amendment to Loan and Security Agreement dated April 8, 2022 between Harrow, Inc. and Melt Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q of Harrow, Inc. filed with the Securities and Exchange Commission on November 14, 2022)
10.39
Second Amendment to Loan and Security Agreement dated September 21, 2022 between Harrow, Inc. and Melt Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of Harrow, Inc. filed with the Securities and Exchange Commission on November 14, 2022)
10.40
Asset Purchase Agreement dated December 17, 2021 between Harrow, Inc. and Novartis Technology, LLC and Novartis Ophthalmics AG (incorporated herein by reference to Exhibit 10.51 to the Annual Report on Form 10-K of Harrow, Inc. filed with the Securities and Exchange Commission on March 10, 2022).
10.41
Asset Purchase Agreement dated December 13, 2022 between Harrow, Inc. and Novartis Technology, LLC and Novartis Innovative Therapies AG (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Harrow, Inc. filed with the Securities and Exchange Commission on December 14, 2022).
10.42
Loan and Security Agreement dated December 14, 2022 between Harrow, Inc. and B. Riley Commercial Capital LLC (incorporated herein by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q of Harrow, Inc. filed with the Securities and Exchange Commission on May 11, 2023).
10.43
Credit and Guaranty Agreement dated March 27, 2023 between Harrow, Inc. and Oaktree Fund Administration, LLC (incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of Harrow, Inc. filed with the Securities and Exchange Commission on May 11, 2023).
10.44
First Amendment to Credit Agreement and Guaranty dated July 18, 2023 to the Credit Agreement and Guaranty dated March 27, 2023 between Harrow, Inc. and Oaktree Fund Administration, LLC (incorporated herein by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q of Harrow, Inc. filed with the Securities and Exchange Commission on August 9, 2023).
10.45
Second Amendment to License and Supply Agreement dated August 4, 2023 between Harrow IP, LLC and Sintetica S.A (incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of Harrow, Inc. filed with the Securities and Exchange Commission on November 13, 2023).
72
10.46*
Third Amendment to License and Supply Agreement dated February 6, 2024 between Harrow IP, LLC and Sintetica S.A
21.1*
List of Subsidiaries
23.1*
Consent of Independent Registered Public Accounting Firm
24.1*
Power of Attorney (included on the signature page to this Annual Report)
31.1*
Certification of Mark L. Baum, Chief Executive Officer, pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities and Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Andrew R. Boll, Chief Financial Officer, pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities and Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, executed by Mark L. Baum, Chief Executive Officer.
32.2**
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, executed by Andrew R. Boll, Chief Financial Officer.
97*
Harrow, Inc. Policy Regarding the Mandatory Recovery of Compensation.
101.INS*
XBRL
Instant Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the
Inline XBRL document.
101.SCH*
Inline
XBRL Taxonomy Extension Schema Document
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
Inline
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
104
The
cover page from the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 has been formatted in Inline
XBRL
#
Management
contract or compensatory plan or arrangement.
*
Filed
herewith.
**
Furnished
herewith.
+
Confidential
treatment has been granted with respect to portions of this exhibit pursuant to Rule 24b-2 of the Exchange Act and these confidential
portions have been redacted from the filing that is incorporated herein by reference. A complete copy of this exhibit, including
the redacted terms, has been separately filed with the Securities and Exchange Commission.
ITEM
16. FORM 10-K SUMMARY
None.
73
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
HARROW,
INC.
By:
/s/
Mark L. Baum
Mark
L. Baum
Chief
Executive Officer (Principal Executive Officer)
Date:
March
19, 2024
POWER
OF ATTORNEY
KNOW
ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Mark L. Baum and Andrew R. Boll,
and each of them individually, as his true and lawful attorneys-in-fact and agents with full power of substitution and resubstitution,
for him and in his name, place and stead, in any and all capacities to any or all amendments to this Annual Report, and to file the same,
with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents or any of them the full power and authority to do and perform each and every act and thing requisite and
necessary to be done in and about the foregoing, as full to all intents and purposes as he might or could do in person, hereby ratifying
and confirming all that said attorneys-in-fact and agents or any of them, or his substitutes, may lawfully do or cause to be done by
virtue thereof.
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/
Mark L. Baum
Chief
Executive Officer and Chairman of the Board
March
19, 2024
Mark
L. Baum
(Principal
Executive Officer)
/s/
Andrew R. Boll
Chief
Financial Officer and Corporate Secretary
March
19, 2024
Andrew
R. Boll
(Principal
Accounting and Financial Officer)
/s/
Adrienne L. Graves
Director
March
19, 2024
Adrienne
L. Graves
/s/
Teresa F. Sparks
Director
March
19, 2024
Teresa
F. Sparks
/s/
Lauren P. Silvernail
Director
March
19, 2024
Lauren
P. Silvernail
/s/
Perry J. Sternberg
Director
March
19, 2024
Perry
J. Sternberg
/s/
Martin Makary
Director
March
19, 2024
Martin
Makary
74
FINANCIAL
STATEMENTS
Harrow,
Inc.
Index
to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 170 )
F-2
Consolidated Balance Sheets at December 31, 2023 and 2022
F-4
Consolidated Statements of Operations for the years ended December 31, 2023 and 2022
F-5
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2023 and 2022
F-6
Consolidated Statements of Cash Flows for the years ended December 31, 2023 and 2022
F-7
Notes to the Consolidated Financial Statements
F-8
F- 1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Stockholders and Board of Directors
Harrow, Inc.
Opinion
on the Consolidated Financial Statements
We
have audited the accompanying consolidated balance sheets of Harrow, Inc. and subsidiaries (the “Company”) as of December
31, 2023 and 2022, the related consolidated statements of operations, stockholders’ equity and cash flows for each of the two years
in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position
of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the
period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting
Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with
the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audits provide a reasonable basis for our opinion.
Critical
Audit Matter
The
critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that
was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material
to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication
of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we
are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts
or disclosures to which it relates.
F- 2
Product
Sales Deductions – Branded Products
Critical
Audit Matter Description
As
described in Note 3 to the consolidated financial statements, revenues from branded product sales are recognized net of accruals for
estimated rebates, wholesaler chargebacks, discounts, copay assistance and other deductions (collectively, “sales deductions”), which are established
at the time of sale. Management’s estimate of sales deductions for branded products is based on the inventory levels in the distribution
channel as provided by wholesalers, as well as the actual average selling price for each product which is impacted by changes in customer
mix, changes in negotiated terms with customers, and changes in the volume of purchases. In addition, management utilizes the services
of a third-party professional services firm to estimate rebates and chargebacks associated with sales of its branded products.
We
identified the estimates of accruals for sales deductions as a critical audit matter given the limited sales history of the Company’s
branded products and the significant judgment required by management with respect to the measurement uncertainty, as the calculation
of the sales deductions includes assumptions such as average selling price, purchasing trends of wholesalers and historical branded product
sales used to predict future sales. This required a high degree of auditor judgment and an increased extent of audit effort in applying
the procedures related to management’s assumptions.
How
the Critical Audit Matter Was Addressed in the Audit
To
test management’s estimated branded product sales deductions, we obtained management’s calculations for the respective estimates
and performed the following procedures, among others. We tested management’s estimation process for determining accruals for product
sales deductions by developing an independent expectation of the estimated accrual rates, including comparison of rates used in management’s
analysis to external industry data, historical actual information, and executed third-party contracts. We evaluated management’s
historic ability to accurately estimate the sales deduction accruals by retrospectively comparing historically recorded accruals to the
actual amounts that were ultimately claimed by the wholesalers. In addition, we assessed subsequent events to determine whether there
was any new information that would require adjustment to the accruals.
/s/
KMJ Corbin & Company LLP
We
have served as the Company’s auditor since 2007.
Irvine,
California
March
19, 2024
F- 3
HARROW,
INC.
CONSOLIDATED
BALANCE SHEETS
December
31, 2023
December
31, 2022
ASSETS
Current assets
Cash and cash
equivalents
$ 74,085,000
$ 96,270,000
Investment in Eton Pharmaceuticals
8,681,000
5,589,000
Accounts receivable, net
36,261,000
6,249,000
Inventories
10,867,000
6,541,000
Prepaid
expenses and other current assets
9,588,000
3,611,000
Total current assets
139,482,000
118,260,000
Property, plant and equipment, net
3,521,000
3,486,000
Capitalized software costs, net
2,138,000
2,112,000
Deferred financing costs
-
1,950,000
Operating lease right-of-use assets, net
6,785,000
7,513,000
Intangible assets, net
159,906,000
23,725,000
Goodwill
332,000
332,000
TOTAL
ASSETS
$ 312,164,000
$ 157,378,000
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
-
Accounts payable and accrued
expenses
$ 24,581,000
$ 13,771,000
Accrued rebates and copay
assistance
18,432,000
-
Accrued payroll and related
liabilities
5,450,000
4,025,000
Deferred revenue and customer
deposits
75,000
113,000
Current
portion of operating lease obligations
806,000
723,000
Total current liabilities
49,344,000
18,632,000
Operating lease obligations, net of current
portion
6,524,000
7,332,000
Accrued expenses, net of current portion
2,713,000
-
Notes payable, net of
unamortized debt discount and issuance costs
183,172,000
104,174,000
TOTAL
LIABILITIES
241,753,000
130,138,000
Commitments and contingencies
-
-
STOCKHOLDERS’ EQUITY
Common stock, $ 0.001 par value, 50,000,000
shares authorized, 35,168,260 and 29,901,530 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively
35,000
30,000
Additional paid-in capital
204,635,000
137,058,000
Accumulated
deficit
( 133,904,000 )
( 109,493,000 )
TOTAL HARROW, INC. STOCKHOLDERS’
EQUITY
70,766,000
27,595,000
Noncontrolling
interests
( 355,000 )
( 355,000 )
TOTAL
STOCKHOLDERS’ EQUITY
70,411,000
27,240,000
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 312,164,000
$ 157,378,000
The
accompanying notes are an integral part of these consolidated financial statements
F- 4
HARROW,
INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
2023
2022
For the Years Ended
December
31,
2023
2022
Revenues:
Product sales,
net
$ 117,447,000
$ 83,524,000
Other
revenues
12,746,000
5,071,000
Total revenues
130,193,000
88,595,000
Cost of sales
( 39,640,000 )
( 25,383,000 )
Gross profit
90,553,000
63,212,000
Operating expenses:
Selling, general and administrative
83,090,000
58,243,000
Research and development
6,652,000
3,050,000
Impairment
of intangible assets
380,000
-
Total operating expenses
90,122,000
61,293,000
Income from operations
431,000
1,919,000
Other (expense) income:
Interest expense, net
( 21,324,000 )
( 7,244,000 )
Equity in losses of unconsolidated
entities
-
( 11,133,000 )
Investment gain (loss)
from Eton Pharmaceuticals
3,092,000
( 2,914,000 )
Loss on extinguishment
of debt
( 5,465,000 )
-
Gain on sale of non-ophthalmology
assets
-
5,259,000
Other
(expense) income, net
( 444,000 )
102,000
Total other expense,
net
( 24,141,000 )
( 15,930,000 )
Loss before income tax provision
( 23,710,000 )
( 14,011,000 )
Income
tax provision
( 701,000 )
( 75,000 )
Net loss attributable
to Harrow, Inc.
$ ( 24,411,000 )
$ ( 14,086,000 )
Basic and diluted net
loss per share of common stock
$ ( 0.75 )
$ ( 0.51 )
Weighted average number
of shares of common stock outstanding, basic and diluted
32,616,777
27,460,968
The
accompanying notes are an integral part of these consolidated financial statements
F- 5
HARROW,
INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
For
the Years Ended December 31, 2023 and 2022
Total
Total
Common
Stock
Additional
Harrow,
Inc.
Noncontrolling
Total
Par
Paid-in
Accumulated
Stockholders’
Interest
Stockholders’
Shares
Value
Capital
Deficit
Equity
Equity
Equity
Balance at December 31, 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 consultant stock-based options
19,679
-
55,000
-
55,000
-
55,000
Exercise of employee stock-based options
221,086
1,000
586,000
-
587,000
-
587,000
Exercise of warrants
306,347
-
-
-
-
-
-
Vesting of RSUs
185,000
1,000
( 1,000 )
-
-
-
-
Shares withheld related
to net share settlement of equity awards
( 109,771 )
( 1,000 )
( 875,000 )
-
( 876,000 )
-
( 876,000 )
Issuance of common shares from public offering,
net of offering costs
2,376,426
2,000
22,653,000
-
22,655,000
-
22,655,000
Stock-based compensation expense
-
-
7,974,000
-
7,974,000
-
7,974,000
Net loss
-
-
-
( 14,086,000 )
( 14,086,000 )
-
( 14,086,000 )
Balance at December 31, 2022
29,901,530
$ 30,000
$ 137,058,000
$ ( 109,493,000 )
$ 27,595,000
$ ( 355,000 )
$ 27,240,000
Balance
29,901,530
$ 30,000
$ 137,058,000
$ ( 109,493,000 )
$ 27,595,000
$ ( 355,000 )
$ 27,240,000
Issuance of common stock in connection with:
Public offering, net of
offering costs
3,887,324
4,000
64,516,000
-
64,520,000
-
64,520,000
Exercise of consultant stock-based options
10,000
-
85,000
-
85,000
-
85,000
Exercise of employee stock-based options
235,975
-
294,000
-
294,000
-
294,000
Vesting of RSUs and PSUs
1,847,876
2,000
( 2,000 )
-
-
-
-
Shares withheld related
to net share settlement of equity awards
( 714,445 )
( 1,000 )
( 13,012,000 )
-
( 13,013,000 )
-
( 13,013,000 )
Stock-based compensation expense
-
-
15,696,000
-
15,696,000
-
15,696,000
Net loss
-
-
-
( 24,411,000 )
( 24,411,000 )
-
( 24,411,000 )
Balance at December 31, 2023
35,168,260
$ 35,000
$ 204,635,000
$ ( 133,904,000 )
$ 70,766,000
$ ( 355,000 )
$ 70,411,000
Balance
35,168,260
$ 35,000
$ 204,635,000
$ ( 133,904,000 )
$ 70,766,000
$ ( 355,000 )
$ 70,411,000
The
accompanying notes are an integral part of these consolidated financial statements
F- 6
HARROW,
INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
2023
2022
For the Years Ended
December
31,
2023
2022
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$ ( 24,411,000 )
$ ( 14,086,000 )
Adjustments to reconcile
net loss to net cash provided by operating activities:
Depreciation and amortization
of property, plant and equipment and software development costs
1,530,000
1,477,000
Amortization of intangible
assets
10,082,000
1,578,000
Amortization of operating
lease right-of-use assets
728,000
610,000
Provision for credit losses
332,000
81,000
Amortization of debt issuance
costs and debt discount
4,097,000
782,000
Investment (gain) loss
from investment in Eton
( 3,092,000 )
2,914,000
Equity in losses of unconsolidated
entities
-
11,133,000
Loss on disposal of equipment
168,000
69,000
Impairment of intangible
assets
380,000
-
Loss on extinguishment
of debt
5,465,000
-
Stock-based compensation
15,696,000
7,974,000
Gain on sale of non-ophthalmology
assets
-
( 5,259,000 )
Changes in assets and liabilities:
Accounts receivable
( 30,344,000 )
( 1,860,000 )
Inventories
( 4,326,000 )
( 2,324,000 )
Prepaid expenses and other
current assets
( 5,647,000 )
( 3,350,000 )
Accounts payable, accrued
expenses, accrued rebates and copay assistance
31,795,000
933,000
Accrued payroll and related
liabilities
1,425,000
936,000
Deferred
revenue and customer deposits
( 38,000 )
97,000
NET CASH PROVIDED BY
OPERATING ACTIVITIES
3,840,000
1,705,000
CASH FLOWS FROM INVESTING ACTIVITIES
Proceeds from sale of non-ophthalmology
assets
-
6,000,000
Investment in patent and
trademark assets
( 18,000 )
( 176,000 )
Proceeds from sale of property,
plant and equipment
-
30,000
Purchase of product NDAs,
marketing authorizations and patents
( 151,075,000 )
( 5,000,000 )
Purchases
of property, plant and equipment
( 1,460,000 )
( 2,597,000 )
NET CASH USED IN INVESTING
ACTIVITIES
( 152,553,000 )
( 1,743,000 )
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from 11.875% notes
payable, net of costs
4,961,000
31,738,000
Proceeds from Oaktree Loan,
net of costs
73,552,000
-
Payment of payroll taxes
upon vesting of PSUs, RSUs and exercise of stock options
( 13,013,000 )
( 876,000 )
Proceeds from exercise
of stock options
379,000
642,000
Proceeds from B Riley senior
secured note, net of costs
55,879,000
-
Repayment of B. Riley senior
secured note
( 59,750,000 )
-
Proceeds from public offering
of common stock, net of offering costs
64,520,000
22,655,000
Payments
on finance lease obligations
-
( 18,000 )
NET CASH PROVIDED BY
FINANCING ACTIVITIES
126,528,000
54,141,000
NET CHANGE IN CASH AND CASH EQUIVALENTS
( 22,185,000 )
54,103,000
CASH
AND CASH EQUIVALENTS, beginning of year
96,270,000
42,167,000
CASH
AND CASH EQUIVALENTS, end of year
$ 74,085,000
$ 96,270,000
SUPPLEMENTAL DISCLOSURE
OF CASH FLOW INFORMATION:
Cash
paid for income taxes
$ -
$ 75,000
Cash
paid for interest
$ 18,887,000
$ 6,480,000
SUPPLEMENTAL DISCLOSURES
OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Reclassification
of deferred financing costs
$ 1,950,000
$ -
Accrual
of exit fee related to Oaktree Loan
$ 2,713,000
$ -
Insurance
premium financed
$ 873,000
$ 906,000
Purchase
of intangible asset included in accounts payable and accrued expenses
$ -
$ 5,000,000
Purchase
of property, plant and equipment included in accounts payable and accrued expenses
$ 299,000
$ 123,000
Right-of-use
assets obtained in exchange for new operating lease obligations
$ -
$ 2,188,000
The
accompanying notes are an integral part of these consolidated financial statements
F- 7
HARROW,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
For
the Years Ended December 31, 2023 and 2022
NOTE
1. ORGANIZATION
Harrow,
Inc. (together with its consolidated subsidiaries, unless the context indicates or otherwise requires, the “Company” or “Harrow”)
is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical
products for the U.S. market. Harrow helps U.S. eyecare professionals preserve the gift of sight by making its comprehensive portfolio
of prescription and non-prescription pharmaceutical products accessible and affordable to millions of Americans each year. The Company
owns commercial rights to one of the largest portfolios of branded ophthalmic pharmaceutical products in the U.S. that are marketed under
its Harrow name. The Company also owns and operates ImprimisRx, one of the nation’s leading ophthalmology-focused pharmaceutical-compounding
businesses.
The
Company owns non-controlling equity interests in Surface Ophthalmics, Inc. (“Surface”) and Melt Pharmaceuticals, Inc. (“Melt”),
both companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in various drug candidates being developed by Surface
and Melt.
Effective
September 29, 2023, the Company changed its corporate name from Harrow Health, Inc. to Harrow, Inc. pursuant to a Certificate of Amendment
to the Company’s Amended and Restated Certificate of Incorporation filed with the Secretary of State of the State of Delaware.
NOTE
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
Harrow
has prepared the accompanying consolidated financial statements in accordance with accounting principles generally accepted in the United
States of America (“GAAP”). The accompanying consolidated financial statements include the accounts of the Company and its
wholly owned and majority-owned subsidiaries.
Harrow
consolidates entities in which it has a controlling financial interest. The Company assesses control under the variable interest entity
(“VIE”) model to determine whether the Company is the primary beneficiary of that entity. The Company consolidates (i) entities
in which it holds and/or controls, directly or indirectly, more than 50% of the voting rights, and (ii) VIEs for which the Company is
deemed to be the primary beneficiary. All intercompany accounts and transactions have been eliminated in consolidation.
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and judgments that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported
amounts of revenues and expenses during the reporting periods. Significant estimates made by management are, among others, allowance
for credit losses, variable consideration determined based on accruals for chargebacks, administrative fees and rebates, government rebates,
returns and other allowances, renewal periods and discount rates for leases, realizability of inventories, recoverability of investments,
realizability of deferred tax assets, recoverability of long-lived assets and goodwill, valuations and purchase price allocations related
to business combinations and asset acquisitions, fair value of loans payable, and valuation of stock-based transactions with employees
and non-employees. Actual results could differ from those estimates.
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.
F- 8
Credit
Losses
The
Company estimates and records a provision for its expected credit losses related to its financial instruments, including its trade receivables.
Management considers historical collection rates, the current financial status of the Company’s customers, macroeconomic factors,
and other industry-specific factors when evaluating current expected credit losses. Forward-looking information is also considered in
the evaluation of current expected credit losses. However, because of the short time to the expected receipt of accounts receivable,
management believes that the carrying value, net of expected losses, approximates fair value and therefore, relies more on historical
and current analysis of such financial instruments, including its trade receivables.
To
determine the provision for credit losses for accounts receivable, the Company has disaggregated its accounts receivable by class of
customer at the business component level, as management determined that risk profile of the Company’s customers is consistent based
on the type and industry in which they operate, mainly in the pharmaceuticals industry. Each business component is analyzed for estimated
credit losses individually. In doing so, the Company establishes a historical loss matrix, based on the previous collections of accounts
receivable by the age of such receivables, and evaluates the current and forecasted financial position of its customers, as available.
Further, the Company considers macroeconomic factors and the status of the pharmaceuticals industry to estimate if there are current
expected credit losses within its trade receivables based on the trends of the Company’s expectation of the future status of such
economic and industry-specific factors. Also, specific allowance amounts are established based on review of outstanding invoices to record
the appropriate provision for customers that have a higher probability of default.
Accounts
receivable at December 31, 2023 and 2022 are net of allowances for credit losses of $ 371,000 and $ 73,000 , respectively. The following
table provides a roll-forward of the allowance for credit losses that is deducted from the amortized cost basis of accounts receivable
to present the net amount expected to be collected at December 31, 2023 and 2022:
SCHEDULE
OF ACCOUNTS RECEIVABLE ALLOWANCE OF CREDIT LOSS
Balance at January 1, 2023
$ 73,000
Change in expected credit
losses
332,000
Write-offs,
net of recoveries
( 34,000 )
Balance at December 31, 2023
$ 371,000
Business
Combinations and Asset Acquisitions
The
Company evaluates acquisitions of assets and other similar transactions to assess whether the transaction should be accounted for as
a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross
assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction
is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether the Company has acquired
inputs, process, and output, which would meet the requirements of a business. If determined to be a business combination, the Company
accounts for the transaction under the acquisition method of accounting as indicated in Financial Accounting Standards Board (“FASB”)
Accounting Standards Codification (“ASC”).
ASC
805, Business Combinations , requires the acquiring entity in a business combination to recognize the fair value of all assets
acquired, liabilities assumed, and any non-controlling interest in the acquiree and establishes the acquisition date as the fair value
measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including any
contingent assets and liabilities, and any non-controlling interest in the acquiree based on the fair value estimates as of the date
of acquisition. The Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration
paid over the fair value of the identified net assets acquired.
The
consideration for the Company’s business acquisitions may include future payments that are contingent upon the occurrence of a
particular event or events. The obligation for such contingent consideration payments are recorded at fair value on the acquisition date.
The contingent consideration obligations are then evaluated each reporting period. Changes in the fair value of contingent consideration,
other than changes due to payments, would be recognized as a gain or loss and recorded in the consolidated statement of operations.
F- 9
If
determined to be an asset acquisition, the Company accounts for the transaction under ASC 805-50, Business Combinations – Related
Issues , which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on
the cost to the acquiring entity or a relative fair value basis, which includes transaction costs in addition to consideration given.
No gain or loss is recognized as of the date of acquisition unless the fair value of non-cash assets given as consideration differs from
the assets’ carrying amounts on the acquiring entity’s financial statements. Consideration transferred that is non-cash will
be measured based on either the cost (which shall be measured based on the fair value of the consideration given) or the fair value of
the assets acquired, and liabilities assumed, whichever is more clearly evident and more reliably measurable. The obligation for contingent
consideration payments is recorded when probable and reasonably estimable. Contingent consideration recognized is included in the initial
cost of the assets acquired and any subsequent changes in the recorded amount of contingent consideration are recognized as an adjustment
to the cost basis of the acquired assets and allocated to the acquired assets based on the relative fair value at the date of acquisition.
Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired
is allocated to the identifiable assets based on relative fair values.
Noncontrolling
Interests
The
Company recognizes any noncontrolling interest as a separate line item in equity in the 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 that are considered as well, such as decision-making rights. When applicable, and in prior periods, the Company includes
the amount of net loss attributable to noncontrolling interests in consolidated net loss on the face of the consolidated statements of
operations.
The
Company provides in the 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 interests 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.
The
noncontrolling interests in the consolidated balance sheets as of December 31, 2023 and 2022, relate to consolidated subsidiaries that
the Company owns a controlling interest in, but not 100% of the equity interests, and that no longer have active operations, assets and
related financial activity.
Revenue
Recognition and Deferred Revenue
The
Company recognizes revenue at the time of transfer of promised goods or services to customers in an amount that reflects the consideration
to which the Company expects to be entitled in exchange for those goods or services (see Note 3).
Cost
of Sales
Cost
of sales includes direct and indirect costs to manufacture formulations and other products sold, including active pharmaceutical ingredients,
personnel costs, packaging, storage, royalties, shipping and handling costs, depreciation and amortization of certain intangible assets
and the write-off of obsolete inventory.
Research
and Development
Research
and development (“R&D”) expenses consist of expenses incurred in performing research and development activities, including
salaries and benefits, other overhead expenses, and costs related to clinical trials, contract services and outsourced contracts. We
expense all costs related to R&D as they are incurred.
F- 10
Upfront
and milestone payments related to the acquisition and licensing of technology for drug and product candidates that are not yet approved
by the FDA are considered acquisition of in process R&D and expensed as R&D in the period in which the expense occurs.
Debt
Issuance Costs and Debt Discount
Debt
issuance costs and the debt discount are recorded net of notes payable in the consolidated balance sheets. Amortization of debt issuance
costs and the debt discount is calculated using the effective interest method over the term of the related debt and is recorded in interest
expense in the accompanying consolidated statements of operations. At December 31, 2022, the Company recorded deferred financing costs
of $ 1,950,000 related to the B. Riley Loan and Security Agreement (the “BR Loan”), which was recorded as a debt issuance
cost and net of the related BR Loan when it funded in January 2023 (see Note 13).
Intellectual
Property
The
costs of acquiring intellectual property rights to be used in the research and development process, including licensing fees and milestone
payments, are charged to research and development expense as incurred in situations where the Company has not identified an alternative
future use for the acquired rights, and are capitalized in situations where we have identified an alternative future use for the acquired
rights. Patents and trademarks are recorded at cost and capitalized at a time when the future economic benefits of such patents and trademarks
become more certain (see “Goodwill and Intangible Assets” below). If costs are not capitalized they are expensed as incurred.
Income
Taxes
As
part of the process of preparing the Company’s consolidated financial statements, the Company must estimate the actual current
tax assets and liabilities and assess permanent and temporary differences that result from differing treatment of items for tax and accounting
purposes. The temporary differences result in deferred tax assets and liabilities, which are included within the consolidated balance
sheets. The Company must assess the likelihood that the deferred tax assets will be recovered from future taxable income and, to the
extent the Company believes that recovery is not more likely than not, a valuation allowance must be established which reduces the amount
of deferred tax assets recorded on the consolidated balance sheets. To the extent the Company establishes a valuation allowance or increase
or decrease this allowance in a period, the impact will be included in income tax expense in the consolidated statements of operations.
The
Company accounts for income taxes under the provisions of Financial Accounting Standards Board (“FASB”) Accounting
Standards Codification (“ASC”) 740, Income Taxes . As of December 31, 2023 and 2022, there was $ 2,853,000
and $ 0 ,
respectively, of unrecognized tax benefits included in the consolidated balance sheets that would, if recognized, affect the
effective tax rate. The Company’s practice is to recognize interest and/or penalties related to income tax matters in income
tax expense. The Company had no accrual for interest or penalties in its consolidated balance sheets at December 31, 2023 and 2022,
and has not recognized interest and/or penalties in the consolidated statements of operations for the years ended December 31, 2023
and 2022. The Company is subject to taxation in the United States, California,
New Jersey, Tennessee, and various other states. The Company’s tax years since 2000 may be subject to examination by the
federal and state tax authorities due to the carryforward of unutilized net operating losses.
Cash
and Cash Equivalents
Cash
equivalents include short-term, highly liquid investments with maturities of three months or less at the time of acquisition.
F- 11
Concentrations
of Credit Risk
The
Company places its cash with financial institutions deemed by management to be of high credit quality. The Federal Deposit Insurance
Corporation (“FDIC”) provides basic deposit coverage with limits up to $ 250,000 per owner. The Company believes the majority
of its cash deposits are covered under FDIC limits, however there are various accounts in which the Company has deposits in excess of
FDIC limits.
Investment
in Eton Pharmaceuticals, Inc.
The
Company’s investment in Eton Pharmaceuticals, Inc. (“Eton”) consists of common stock with a readily determinable fair
value which is carried at fair value with changes in fair value recognized in earnings. In accordance with ASC 321, Investments —
Equity Securities , the Company recorded an unrealized holding gain/(loss) from its Eton common stock position of $ 3,092,000 and $ ( 2,914,000 ) ,
during the years ended December 31, 2023 and 2022, respectively, related to the change in fair market value of its investment in Eton
during the measurement period.
As
of December 31, 2023 and 2022, the Company owned 1,982,000 shares of Eton common stock, which represents less than 10 % of the equity
interests of Eton. At December 31, 2023 and 2022, the fair market value of Eton’s common stock was $ 4.38 and $ 2.82 per share, respectively.
As of December 31, 2023 and 2022, the fair market value of the Company’s investment in Eton was $ 8,681,000 and $ 5,589,000 , respectively.
Accounts
Receivable
Accounts
receivable are stated net of allowances for credit losses and contractual adjustments. The accounts receivable balance primarily includes
amounts due from customers the Company has invoiced or from third-party providers (e.g., insurance companies and governmental agencies),
but for which payment has not been received. Our gross product revenues are subject to a variety of contractual deductions, which generally
are estimated and recorded in the same period that the revenues are recognized. These deductions represent estimates of the related obligations
and, as such, knowledge and judgment are required when estimating the impact of these revenue deductions on gross sales for a reporting
period. Accounts receivable at December 31, 2023 are presented net of allowances for credit losses of $ 371,000 and $ 14,875,000 for contractual
adjustments (in aggregate $ 15,146,000 ) and at December 31, 2022, net of allowances for credit losses of $ 73,000 and $ 706,000 for contractual
adjustments (in aggregate $ 779,000 ).
Inventories
Inventories
are stated at the lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. The Company evaluates the
carrying value of inventories on a regular basis, based on the price expected to be obtained for products in their respective markets
compared with historical cost. Write-downs of inventories are considered to be permanent reductions in the cost basis of inventories.
The
Company also regularly evaluates its inventories for excess quantities and obsolescence (expiration), taking into account such factors
as historical and anticipated future sales or use in production compared to quantities on hand and the remaining shelf life of products
and active pharmaceutical ingredients on hand. The Company establishes reserves for excess and obsolete inventories as required based
on its analyses.
Investment
in Melt Pharmaceuticals, Inc. – Related Party
The
Company owns 3,500,000 shares of common stock and 2,334,256 shares of preferred stock of Melt (representing in aggregate approximately
47 % of the equity interests as of December 31, 2023). 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 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 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 December 31, 2022, and at the time of entering
into the Melt Loan Agreement (see Note 5), 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 treated interest paid in kind on the Melt Loan Agreement
as an in-substance capital contribution and reduced its investment in Melt accordingly, rather than recording interest income.
F- 12
On
a quarterly basis, management assesses whether there are any indicators that the carrying value of the Company’s equity method
investments may be other than temporarily impaired. Indicators include financial condition, operating performance, and near-term prospects
of the investee. To the extent indicators suggest that a loss in value may have occurred, the Company will evaluate both quantitative
and qualitative factors to determine if the loss in value is other than temporary. If a potential loss in value is determined to be other
than temporary, the Company will recognize an impairment loss based on the estimated fair value of the equity method investments. During
the year ended December 31, 2023, the Melt Loan Agreement (as defined in Note 5) was settled in exchange for Melt preferred stock (see
Note 5 for loan settlement disclosure). The Company reduced the Melt Loan Agreement and subsequent preferred stock investment in Melt
to $ 0 as a result of the Company recording its share of equity losses of Melt. The Company has no other investments in Melt and no other
requirements to advance funds to Melt.
The
following table summarizes the Company’s investments in Melt as of December 31, 2023:
SCHEDULE OF INVESTMENT
Cost
Basis
Share
of Equity
Method Losses
Net
Carrying value
Common stock
$ 5,810,000
$ ( 5,810,000 )
$ -
Preferred stock
18,397,000
( 18,397,000 )
-
$ 24,207,000
$ ( 24,207,000 )
$ -
The
following table summarizes the Company’s investments in Melt as of December 31, 2022:
Cost
Basis
Share
of Equity
Method Losses
Paid-in-Kind
Interest
In-substance
Capital Contributions
Net
Carrying value
Common stock
$ 5,810,000
$ ( 5,810,000 )
$ -
$ -
$ -
Loan
13,500,000
( 13,500,000 )
2,484,000
( 2,484,000 )
-
$ 19,310,000
$ ( 19,310,000 )
$ 2,484,000
$ ( 2,484,000 )
$ -
At
December 31, 2023 and 2022, the Company recorded $ 89,000 and $ 139,000 , respectively, due from Melt for reimbursable expenses and amounts
due under 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 consolidated balance sheets.
See
Note 5 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 and no other requirements to advance funds to Surface.
F- 13
The
following table summarizes the Company’s investment in Surface as of December 31, 2023 and 2022:
SCHEDULE OF INVESTMENT
Cost
Basis
Share
of Equity Method Losses
Net
Carrying value
Common
stock
$ 5,320,000
$ ( 5,320,000 )
$ -
See
Note 6 for more information and related party disclosure regarding Surface.
Property,
Plant and Equipment
Property,
plant and equipment is stated at cost less accumulated depreciation and amortization. Depreciation and amortization is calculated using
the straight-line method over the estimated useful life of the asset. Leasehold improvements and finance lease equipment are amortized
over the estimated useful life or remaining lease term, whichever is shorter. Computer hardware and furniture and equipment are depreciated
over three to five years .
Capitalized
Software Costs
The
Company capitalizes certain costs related to the development of internal-use software. Costs incurred during the application development
phase are capitalized only when the Company believes it is probable the development will result in new or additional functionality. The
types of costs capitalized during the application development phase include consulting fees for third-party developers working on these
projects. Costs related to the preliminary project stage and post-implementation activities are expensed as incurred. Internal-use software
is amortized on a straight-line basis over the estimated useful life of the asset, which ranges from two to five years . When internal-use
software that was previously capitalized is abandoned, the cost less the accumulated amortization, if any, is recorded as amortization
expense. Fully amortized capitalized internal-use software costs are removed from their respective accounts.
Goodwill
and Intangible Assets
Patents
and trademarks are recorded at cost and capitalized at a time when the future economic benefits of such patents and trademarks become
more certain. At that time, the Company capitalizes third-party legal costs and filing fees associated with obtaining and prosecuting
claims related to its patents and trademarks. Once the patents have been issued, the Company amortizes these costs over the shorter of
the legal life of the patent or its estimated economic life, generally 20 years, using the straight-line method. Acquired product rights,
including new drug applications (“NDAs”), are amortized over their estimated useful lives, generally 4 - 15 years, based on
a straight-line method. Trademarks are an indefinite-lived intangible asset and are assessed for impairment based on future projected
cash flows as further described below.
The
Company reviews its goodwill and indefinite-lived intangible assets for impairment as of January 1 of each year and when an event or
a change in circumstances indicates the fair value of a reporting unit may be below its carrying amount. Events or changes in circumstances
considered as impairment indicators include but are not limited to the following:
●
significant
underperformance of the Company’s business relative to expected operating results;
●
significant
adverse economic and industry trends;
●
significant
decline in the Company’s market capitalization for an extended period of time relative to net book value; and
●
expectations
that a reporting unit will be sold or otherwise disposed.
F- 14
The
goodwill impairment test consists of a two-step process as follows:
Step
1. The Company compares the fair value of each reporting unit to its carrying amount, including the existing goodwill. The fair value
of each reporting unit is determined using a discounted cash flow valuation analysis. The carrying amount of each reporting unit is determined
by specifically identifying and allocating the assets and liabilities to each reporting unit based on headcount, relative revenues or
other methods as deemed appropriate by management. If the carrying amount of a reporting unit exceeds its fair value, goodwill is considered
impaired and the Company then performs the second step of the impairment test to measure the impairment loss. If the fair value of a
reporting unit exceeds its carrying amount, no further analysis is required.
Step
2. If the carrying amount of the reporting unit exceeds its fair value, an impairment loss will be recognized in an amount equal to the
excess, limited to the total amount of goodwill allocated to that reporting unit.
As
a result of its assessment in 2023, the Company concluded that goodwill is not impaired as of December 31, 2023.
Impairment
of Other Long-Lived Assets
Other
long-lived assets, such as property, plant and equipment, purchased intangibles subject to amortization and patents and trademarks, are
reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
Such circumstances could include, but are not limited to (1) a significant decrease in the market value of an asset, (2) a significant
adverse change in the extent or manner in which an asset is used, or (3) an accumulation of costs significantly in excess of the amount
originally expected for the acquisition of an asset. Recoverability of assets to be held and used is measured by a comparison of the
carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount
of an asset exceeds its estimated undiscounted future cash flows, an impairment charge is recognized in the amount by which the carrying
amount of the asset exceeds the fair value of the asset. The fair value of the asset is based on the discounted value of its estimated
future cash flows. Assets to be disposed of would be separately presented in the consolidated balance sheet and reported at the lower
of the carrying amount or fair value less costs to sell, and are no longer depreciated. The assets and liabilities of a disposal group
classified as held-for-sale would be presented separately in the appropriate asset and liability sections of the consolidated balance
sheet, if material.
As
a result of its assessment in 2023, the Company recorded an impairment charge of $ 380,000 related to the impairment of certain licenses,
trademarks, patents and patent applications (see Note 11).
Leases
At
the inception of a contract the Company determines if the arrangement is, or contains, a lease. Operating lease right-of-use (“ROU”)
assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation
to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on
the present value of lease payments over the lease term. Lease expense is recognized on a straight-line basis over the lease term.
The
Company has made certain accounting policy elections whereby it (i) does not recognize ROU assets or lease liabilities for short-term
leases (those with original terms of 12-months of less) and (ii) combines lease and non-lease elements of its operating leases as a single
lease component. As of December 31, 2023 and 2022, the Company did not have any finance leases.
Fair
Value Measurements
Fair
value measurements are determined based on the assumptions that market participants would use in pricing an asset or liability. GAAP
establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of
unobservable inputs by requiring that the most observable inputs be used when available. The established fair value hierarchy prioritizes
the use of inputs used in valuation methodologies into the following three levels:
●
Level
1: Applies to assets or liabilities for which there are quoted prices (unadjusted) for identical assets or liabilities in active
markets. A quoted price in an active market provides the most reliable evidence of fair value and must be used to measure fair value
whenever available.
F- 15
●
Level
2: Applies to assets or liabilities for which there are significant other observable inputs other than Level 1 prices, such as quoted
prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can
be corroborated by observable market data for substantially the full term of the assets or liabilities.
●
Level
3: Applies to assets or liabilities for which there are significant unobservable inputs that reflect a reporting entity’s own
assumptions about the assumptions that market participants would use in pricing an asset or liability. For example, Level 3 inputs
would relate to forecasts of future earnings and cash flows used in a discounted future cash flows method.
At
December 31, 2023 and 2022, the Company measured its investment in Eton on a recurring basis. The Company’s investment in Eton
is classified as Level 1 as the fair value is determined using quoted market prices in active markets for the same securities. As of
December 31, 2023 and 2022, the fair market value of the Company’s investment in Eton was $ 8,681,000 and $ 5,589,000 , respectively.
The
Company’s 2026 Notes (as defined in Note 13) are carried at face value, including the unamortized premium, less unamortized debt
issuance costs, the 2027 Notes (as described in Note 13) are carried at face value less unamortized debt issuance costs, and the Oaktree
Loan (as defined in Note 13) is carried at face value less the original issue discount and unamortized debt issuance costs on the consolidated
balance sheets and the Company presents fair value for disclosure purposes only. The 2026 Notes and 2027 Notes are classified as Level
1 instruments as the fair value is determined using quoted market prices in active markets for the same securities. The Oaktree Loan
is classified as a Level 2 instrument and its fair value is determined through an income approach that considers collateral coverage,
yield calibration, yield analysis and any adjustments to implied yield associated with the Company’s fundamental measures.
The
following table presents the estimated fair values and the carrying values:
SCHEDULE
OF ESTIMATED FAIR VALUE
December
31,
2023
2022
Carrying
Value
Fair
Value
Carrying
Value
Fair
Value
2026 Notes
$ 73,218,000
$ 70,260,000
$ 72,436,000
$ 71,550,000
2027 Notes
$ 37,413,000
$ 40,363,000
$ 31,738,000
$ 35,112,000
Oaktree Loan
$ 72,541,000
$ 76,627,000
$ -
$ -
The
Company’s other financial instruments include cash and cash equivalents, accounts receivable, accounts payable and accrued expenses,
accrued payroll and related liabilities, deferred revenue and customer deposits and operating lease liabilities. The carrying amount
of these financial instruments, except for operating lease liabilities, approximates fair value due to the short-term maturities of these
instruments. Based on borrowing rates currently available to the Company, the carrying values of the operating lease liabilities approximate
their respective fair values.
Stock-Based
Compensation
All
stock-based payments to employees, directors and consultants, including grants of stock options, warrants, restricted stock units (“RSUs”),
performance stock units (“PSUs) and restricted stock, are recognized in the consolidated financial statements based upon their
estimated fair values. The Company uses the Black-Scholes-Merton option pricing model and Monte Carlo simulation model to estimate the
fair value of stock-based awards. The estimated fair value is determined at the date of 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.
Basic
and Diluted Net Loss per Common Share
Basic
net loss per common share is computed by dividing net loss attributable to Harrow, Inc. for the year by the weighted average number of
common shares outstanding during the year. Diluted net loss per share is computed by dividing the net loss attributable to Harrow, Inc.
for the year by the weighted average number of common and common equivalent shares, such as stock options, RSUs, PSUs, and warrants,
outstanding during the year.
F- 16
Common
stock equivalents (using the treasury stock or “if converted” method) from stock options, unvested RSUs, and unvested PSUs
were 4,642,259 and 5,089,420 at December 31, 2023 and 2022, respectively, and are excluded in the calculation of diluted net loss per
share for the periods presented, because the effect is anti-dilutive for that time period. Included in the basic and diluted net loss
per share calculation were RSUs awarded to directors that had vested, but the issuance and delivery of the shares are deferred until
the director resigns. The number of shares underlying vested RSUs at December 31, 2023 and 2022 was 215,539 and 319,859 , respectively.
The
following table shows the computation of basic and diluted net loss per share of common stock for the years ended December 31, 2023 and
2022:
SCHEDULE
OF BASIC AND DILUTED EARNINGS PER COMMON SHARE
For
the Years Ended December 31,
2023
2022
Numerator
– net loss attributable to Harrow, Inc.
$ ( 24,411,000 )
$ ( 14,086,000 )
Denominator –
weighted average number of shares outstanding, basic and diluted
32,616,777
27,460,968
Net
loss per share, basic and diluted
$ ( 0.75 )
$ ( 0.51 )
Recently
Adopted Accounting Pronouncements
In
September 2016, FASB issued Accounting Standards Update (“ASU”) 2016-13, Measurement of Credit Losses on Financial Instruments .
This ASU replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and
requires consideration of a broader range of reasonable and supportable information for credit loss estimates on certain types of financial
instruments, including trade receivables. In addition, new disclosures are required. The ASU, as subsequently amended, is effective for
the Company for the fiscal years beginning after December 15, 2022. The Company adopted ASU 2016-13 on January 1, 2023. Based on the
composition of the Company’s accounts receivable, investment portfolio, and other financial assets, including current market conditions
and historical credit loss activity, the adoption of this standard did not have a material impact on the Company’s consolidated
financial statements or disclosures. Specifically, the Company’s estimate of expected credit losses as of January 1, 2023, using
its expected credit loss evaluation process described above, resulted in no adjustments to the provision for credit losses and no cumulative-effect
adjustment to accumulated deficit on the adoption date of the standard.
Accounting
Guidance Issued but Not Adopted at December 31, 2023
In
August 2023, FASB issued ASU 2023-05, Business Combinations—Joint Venture Formations (Subtopic 805-60): Recognition and Initial
Measurement , which applies to the formation of entities that meet the definition of a joint venture (or a corporate joint venture)
and requires joint ventures to initially measure all contributions received upon formation at fair value. The new guidance does not impact
accounting by the venturers. The new guidance is applicable to joint venture entities with a formation date on or after January 1, 2025
on a prospective basis. Joint ventures formed prior to the effective date may elect to apply the new guidance retrospectively back to
their original formation date. The Company will apply the guidance in ASU 2023-05 prospectively to any future arrangements meeting the
definition of a joint venture.
In
October 2023, the FASB issued ASU 2023-06, Disclosure Improvements—Codification Amendments in Response to the SEC’s Disclosure
Update and Simplification Initiative . This ASU modifies the disclosure or presentation requirements of a variety of topics in the
codification by aligning them with the SEC’s regulations. The amendments to the various topics should be applied prospectively,
and the effective date for the Company for each amendment will be determined based on the effective date of the SEC’s removal of
the related disclosure from Regulation S-X or Regulation S-K. If the SEC has not removed the applicable requirement by June 30, 2027,
then the related amendment in ASU 2023-06 will be removed from the codification and will not become effective. Early adoption of this
ASU is prohibited. The Company does not expect the amendments in this ASU to have a material impact on the disclosures or presentation
in its consolidated financial statements.
F- 17
In
November 2023, FASB issued ASU 2023-07, Segment Reporting (Topic 280) - Improvements to Reportable Segment Disclosures , which
enhances the disclosures required for operating segments in the Company’s annual and interim consolidated financial statements.
ASU 2023-07 is effective for the Company in our annual reporting for fiscal 2024 and for interim period reporting beginning in fiscal
2025 on a retrospective basis, with all required disclosures to be made for all prior periods presented in the consolidated financial
statements. Early adoption is permitted. The Company is currently evaluating the impact of ASU 2023-07 on its consolidated financial
statements.
In
December 2023, FASB issued ASU 2023-09, Income Taxes (Topic 740) - Improvements to Income Tax Disclosures , which enhances the
disclosures required for income taxes in the Company’s annual consolidated financial statements. Notably, this ASU requires entities
to disclose specific categories in the effective tax rate reconciliation and provide additional information for reconciling items that
meet a quantitative threshold. ASU 2023-09 is effective for the Company in its annual reporting for fiscal 2025 on a prospective basis.
Early adoption and retrospective reporting are permitted. The Company is currently evaluating the impact of ASU 2023-09 on its consolidated
financial statements.
Reclassifications
Certain
prior period items and amounts have been reclassified to conform to the classifications used to prepare the consolidated financial statements
for the current period. These reclassifications had no material impact on the Company’s consolidated financial position, results
of operations, or cash flows as previously reported.
NOTE
3. REVENUES
The
Company accounts for contracts with customers in accordance with ASC 606, Revenues from Contracts with Customers . The Company
has three primary streams of revenue (four in 2022): (1) product revenues, including revenue recognized from sales of products through
its pharmacy and outsourcing facility and sales of branded products to wholesalers through a third-party logistics (“3PL”)
partner, (2) revenue recognized from a commission agreement with a third party in 2022, (3) revenue recognized from transfer of acquired
product sales and profits, and (4) revenue recognized from intellectual property licenses.
Product
Revenues
The
Company sells prescription medications directly through its pharmacy, outsourcing facility and 3PL partner. Revenue from the Company’s
pharmacy services includes: (i) the portion of the price the client pays directly to the Company, net of any volume-related or other
discounts paid back to the client, (ii) the price paid to the Company by individuals, and (iii) customer copayments made directly to
the pharmacy network. Sales taxes are not included in revenue. Following the core principles of ASC 606, the Company has identified the
following:
1.
Identify
the contract(s) with a customer: A contract is deemed to exist when the customer places an order through receipt of a prescription,
via an online order or via receipt of a purchase order from a customer. For branded products, orders are received through the Company’s
3PL partner, and the customer takes title of the products via formal purchase orders placed and fulfilled.
2.
Identify
the performance obligations in the contract: Obligations for fulfillment of the Company’s contracts consist of delivering
the product to customers at their specified destination. For shipping and handling activities under ASC 606, if the customer takes
control of the goods after shipment, shipping and handling activities would always be considered a fulfillment activity and not treated
as a separate performance obligation. If the customer takes control of the goods before shipment, entities must make an accounting
policy election to treat shipping and handling activities as either a fulfillment cost or as a separate performance obligation. The
Company has elected to treat its shipping and handling activities as a fulfillment cost.
3.
Determine
the transaction price: The transaction price is based on an amount that reflects the consideration to which the Company expects
to be entitled, net of accruals for estimated rebates, wholesaler chargebacks, discounts, copay assistance and other deductions (collectively, sales
deductions) and an estimate for returns and replacements established at the time of sale. The Company utilizes the services of a
third-party professional services firm to estimate rebates and chargebacks associated with sales of its branded products. The transfer
of promised goods is satisfied within a year, and therefore there are no significant financing components. There is no non-cash consideration
related to product sales.
F- 18
4.
Allocate
the transaction price to the performance obligations in the contract: Because there is only one performance obligation for product
sales, no allocation is necessary.
5.
Recognize
revenue when (or as) the entity satisfies a performance obligation: Revenue from products is recognized upon transfer of control
of a product to a customer. This generally occurs upon shipment unless contractual terms with a customer state that transfer of control
occurs at delivery.
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 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.
Revenues
From Transfer of Acquired Product Sales and Profits
The
Company has entered into agreements whereby it purchased the exclusive commercial rights to assets associated with certain ophthalmic
products from other pharmaceutical companies (the “Sellers”). During a temporary, transition period, the Sellers continue
to manufacture and market these products and transfer the net profit from the sale of the products to the Company. The revenue recognized
by the Company from the transfer of net profit was recognized at the time profit from the product sales were calculated by the Sellers
and confirmed by the Company, typically on a monthly basis, at which point there is no future performance obligation required by the
Company and no consequential continuing involvement on the Company’s part to recognize the associated revenue. On a quarterly basis,
the Sellers invoice the Company for all credits and reimbursements (“Chargebacks”) made to customers related to the products.
The Company uses historical actual experience to estimate Chargebacks associated with the net sales and profit transferred. The estimated
Chargebacks are recorded as a reduction in revenues from transfer of acquired product sales and profits in the Company’s consolidated
statements of operations, and recorded as a reduction to accounts receivable in the consolidated balance sheets, at the time the revenue
is recognized.
Intellectual
Property License Revenues
The
Company currently holds five intellectual property licenses and related agreements pursuant to 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 deliverables are delivered. Such deliverables may include physical quantities of compounded drug preparations, design of
the compounded drug preparations and structure-activity relationships, the conceptual framework and mechanism of action, and rights to
the patents or patent applications for such compounded drug preparations. The Company defers recognition of non-refundable fees if it
has continuing performance obligations without which the technology, right, product or service conveyed in conjunction with the non-refundable
fee has no utility to the licensee and that are separate and independent of the Company’s performance under the other elements
of the arrangement. In addition, if the Company’s continued involvement is required, through research and development services
that are related to its proprietary know-how and expertise of the delivered technology or can only be performed by the Company, then
such non-refundable fees are deferred and recognized over the period of continuing involvement. Guaranteed minimum annual royalties are
recognized on a straight-line basis over the applicable term.
F- 19
Revenue
disaggregated by revenue source for the years ended December 31, 2023 and 2022, consists of the following:
SCHEDULE OF DISAGGREGATED REVENUE
For
the Years Ended
December 31,
2023
2022
Product sales,
net
$ 117,447,000
$ 83,524,000
Commissions
-
3,866,000
Transfer
of acquired product sales/profits
12,746,000
1,205,000
Total
revenues
$ 130,193,000
$ 88,595,000
Deferred
revenue and customer deposits at December 31, 2023 and 2022, were $ 75,000 and $ 113,000 , respectively. All deferred revenue and customer
deposit amounts at December 31, 2022 were recognized as revenue during the year ended December 31, 2023.
NOTE
4. RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES
Acquisition
of VEVYE TM U.S. and Canadian Commercial Rights
In
July 2023, the Company acquired commercial rights of VEVYE (cyclosporine ophthalmic solution) 0.1 %, an ophthalmic drug product, for the
U.S. and Canadian markets (the “VEVYE Acquisition”). The Company acquired the commercial rights to VEVYE by entering into
a license agreement with Novaliq GmbH (“Novaliq”). As consideration, the Company made initial payments to Novaliq totaling
$ 8,000,000 and will pay low double-digit royalties on net sales of VEVYE along with potential commercial milestone payments.
The
Company accounted for the VEVYE Acquisition as an acquisition of assets and capitalized the initial payments of $ 8,000,000 and costs
of $ 70,000 associated with the transaction.
Acquisition
of Certain U.S. and Canadian Commercial Rights to Santen and Eyevance Products
In
July 2023, the Company entered into an Asset Purchase Agreement with Eyevance Pharmaceuticals, LLC and a License Agreement with Santen
S.A.S. (collectively, the “Santen Agreements”), each a subsidiary of Santen Pharmaceuticals Co., Ltd. (collectively, “Santen”).
Pursuant to the Santen Agreements, the Company acquired the exclusive commercial rights to assets associated with the following ophthalmic
products (collectively, the “Santen Products”): FLAREX, NATACYN, ZERVIATE, VERKAZIA and FRESHKOTE in the U.S., and VERKAZIA
and CATIONORM PLUS in Canada.
The
transactions pursuant to the Santen Agreements are referred to in these notes as the “Santen Products Acquisition.”
Under
the terms of the Santen Agreements, the Company made an initial one-time payment of $ 8,000,000 . In addition, the Santen Agreements provide
for various one-time contingent milestone payments associated with certain manufacturing-related events as well as low-double digit royalty
payments on net sales of VERKAZIA and high-single digit royalty payments on net sales of CATIONORM PLUS. Under the Santen Agreements,
the Company also assumed certain obligations associated with other third parties that require mid-single digit royalties on sales of
FRESHKOTE and ZERVIATE. Immediately following the closing and subject to certain conditions, prior to the transfer of the Santen Products
NDAs and other marketing authorizations to the Company, Santen continued to sell the Santen Products on the Company’s behalf and
transfer the net profit from the sale of the Santen Products to the Company. In October 2023, we completed the transfer of the U.S. NDAs
and rights of the Santen Products.
The
assets acquired in the Santen Products Acquisition are identifiable intangible asset groups in similar asset classes and all directly
related to the product NDAs and marketing authorizations acquired. The developed technology is within one major intangible asset class.
No workforce/employees were included in the Santen Products Acquisition and the Company is required to utilize its own business inputs/processes
to transfer and commercialize the Santen Products.
F- 20
The
Company incurred $ 139,000 in costs associated with the Santen Products Acquisition, and including such acquisition costs, the payment
of $ 8,000,000 at closing and a near term milestone of $ 500,000 . The total purchase price of the Santen Products Acquisition was $ 8,639,000
and was accounted for as an asset acquisition. At the time of the Santen Products Acquisition and as of December 31, 2023, the remaining
contingent consideration due was not considered probable and reasonably estimable and therefore, no amount was included in the purchase
price of the Santen Products Acquisition. At the time the contingent consideration due becomes probable and reasonably estimable the
additional consideration, if any, paid will be allocated to all of the assets on a pro rata basis based on their initial estimated fair
values as a percent of the total purchase price.
Acquisition
of ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE
In
December 2022, the Company entered into an Asset Purchase Agreement (the “NVS 5 APA”) with Novartis Technology, LLC and Novartis
Innovative Therapies AG (together, “Novartis”), pursuant to which the Company agreed to purchase from Novartis the exclusive
commercial rights to assets associated with the following ophthalmic products (collectively the “NVS 5 Products”) in the
U.S. (the “NVS 5 Acquisition”): ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE.
Under
the terms of the NVS 5 APA, the Company made a one-time payment of $ 130,000,000 at closing in January 2023, with up to another $ 45,000,000
due in a milestone payment related to the timing of the commercial availability of TRIESENCE. The milestone payment due upon commercial
availability for TRIESENCE decreased from $ 45,000,000 to $ 37,000,000 on January 20, 2024. Pursuant to the NVS 5 APA and various ancillary
agreements, immediately following the closing and subject to certain conditions and prior to the transfer of the NVS 5 Products NDAs
to the Company, Novartis continued to sell the NVS 5 Products on the Company’s behalf and transfer the net profit from the sale
of the NVS 5 Products to the Company. Novartis has agreed to supply certain NVS 5 Products to the Company for a period of time after
the NDAs are transferred and to assist with technology transfer of the NVS 5 Products manufacturing to other third-party manufacturers,
if needed.
The
assets acquired in the NVS 5 Acquisition are identifiable intangible asset groups in similar asset classes and all directly related to
the five product NDAs acquired. The developed technology is within one major intangible asset class. No workforce/employees were included
in the NVS 5 Acquisition and the Company is required to utilize its own business inputs/processes to transfer and commercialize the NVS
5 Products and NDAs.
The
Company incurred $ 558,000 in costs associated with the NVS 5 Acquisition and including such acquisition costs and the payment of $ 130,000,000
at closing. The total purchase price of the NVS 5 Acquisition was $ 130,558,000 and was accounted for as an asset acquisition. At the
time of the NVS 5 Acquisition and as of December 31, 2023, the contingent consideration due related to the commercial availability of
TRIESENCE was not considered probable and reasonably estimable and, therefore, no amount was included in the purchase price of the NVS
5 Acquisition. At the time the contingent consideration due related to the commercial availability of TRIESENCE becomes probable and
reasonably estimable the additional consideration, if any, paid will be allocated to all of the assets on a pro rata basis based on their
initial estimated fair values as a percent of the total purchase price. The Company does not consider any amounts related to TRIESENCE
to be in-process research and development (IPR&D) as considered within the scope of ASC 730, Research and Development .
Divestiture
of Non-Ophthalmic Assets
In
October 2022, wholly-owned subsidiaries of the Company (collectively, “Imprimis”) entered into an Asset Purchase Agreement
(the “RPC Agreement”) with Innovation Compounding Pharmacy, LLC (the “Buyer”). Under the terms of the RPC Agreement,
Imprimis agreed to sell substantially all of its assets associated with its non-ophthalmology related compounding product line, including
but not limited to, certain intellectual property rights, customer lists, databases, and formulations (the “RPC Assets”).
The Buyer agreed to make offers of employment to nine of the Company’s employees that were responsible for the sales activities
associated with the RPC Assets. Under the terms of the RPC Agreement, the Buyer paid Imprimis an aggregate cash amount of $ 6,000,000
in October 2022. In addition, the Buyer is obligated to pay up to $ 4,500,000 to Imprimis based on mutually agreed upon revenue milestones
during the calendar year 2023 (the “Contingent Amount”). During the year ended December 31, 2022, no amount related to the
Contingent Amount was recognized by the Company. The Company will recognize a gain related to the Contingent Amount if/when the contingency
(in this case, revenue thresholds for 2023) become likely and reasonably estimable. The Company is currently engaged in discussions with
RPC related to the contingent payment amount, if any.
F- 21
In
connection with the RPC Agreement, Imprimis entered into a separate transition services agreement (the “RPC TSA”) with the
Buyer related to providing ongoing services associated with the RPC Assets, such as procuring and dispensing prescription orders, providing
accounting and billing services and collecting accounts receivable. Imprimis provided transition services to the Buyer for approximately
nine months following the effective date of the RPC Agreement and expects to wind down transition services in subsequent periods. The
Company collected and will continue to collect cash on behalf of the Buyer for revenue generated by sales of RPC Assets from October
2022 through the transition period and the Company is obligated to transfer cash generated by such sales to the Buyer. The Company’s
consolidated balance sheet as of December 31, 2023 includes accounts receivable of $ 49,000 for cash to be collected on behalf of the
Buyer for sales of RPC Assets through December 31, 2023.
There
were no amounts due from the Buyer for reimbursement of services performed under the RPC TSA as of December 31, 2023. The receivable
amount of $ 49,000 along with $ 8,000 of payments received from accounts receivable but not yet paid were recorded within accounts payable
and accrued expenses on the consolidated balance sheet as of December 31, 2023, and represents a payable to the Buyer of $ 57,000 . The
Company recorded a loss from the RPC TSA and disposition and sale of certain related assets and unusable inventory of $ 330,000 during
the year ended December 31, 2023, which is presented in other expense, net on the consolidated statements of operations.
The
Company determined that the disposal of the related net assets does not qualify for reporting as discontinued operations because it does
not represent a strategic shift that has or will have a major effect on the Company’s operations and financial results. During
the year ended December 31, 2022, the Company recognized a net gain on the sale of the non-ophthalmology related compounding assets as
follows:
SCHEDULE
OF NET GAIN ON SALE OF ASSETS
Gross consideration
$ 6,000,000
Closing and transaction
costs
55,000
Net
proceeds
5,945,000
Book value of assets transferred:
Customer
relations intangible asset
686,000
Gain
on sale of non-ophthalmology assets
$ 5,259,000
License
and Supply Agreement for IHEEZO
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
(“IHEEZO”) in the U.S. and Canada.
Pursuant
to the Sintetica Agreement, the Company agreed to pay Sintetica a per unit transfer price to supply IHEEZO, 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 is responsible for regulatory
filings for IHEEZO in the U.S. The Upfront Payment along with an additional milestone payment of $ 3,117,000 was paid and recorded as
R&D expenses during the year ended December 31, 2021. During the year ended December 31, 2022, $ 10,000,000 was paid or accrued under
the Sintetica Agreement following the FDA approval of the United States NDA for IHEEZO, and was capitalized as an intangible asset. In
August 2023, the Company amended the Sintetica Agreement to allow for early payment of commercial related milestones associated with
sales of IHEEZO in exchange for a $ 550,000 reduction in all of the remaining milestone amounts due. The Company then paid Sintetica $ 4,450,000 .
As of December 31, 2023, no milestone amounts are due under the Sintetica Agreement.
Subject
to certain limitations, the Sintetica Agreement has a ten-year term, and allows for a ten-year extension if certain sales thresholds
are met.
F- 22
NOTE
5. INVESTMENT IN MELT PHARMACEUTICALS, INC. AND AGREEMENTS – RELATED PARTY TRANSACTIONS
In
December 2018, the Company entered into an asset purchase agreement with Melt (the “Melt APA”). Pursuant to the terms of
the Melt APA, Melt was assigned certain intellectual property and related rights from the Company to develop, formulate, make, sell,
and sub-license certain Company conscious sedation and analgesia related formulations (collectively, the “Melt Products”).
Under the terms of the Melt APA, Melt is required to make mid-single digit royalty payments to the Company on net sales of the Melt Products
while any patent rights remain outstanding, as well as other conditions.
In
February 2019, the Company entered into the Melt MSA, whereby the Company provided to Melt certain administrative services and support,
including bookkeeping, web services and human resources related activities, and Melt was required to pay the Company a monthly amount
of $ 10,000 . The Melt MSA was terminated effective July 1, 2023. During the year ended December 31, 2023, and 2022, the Company recorded
$ 89,000 and $ 91,000 , respectively, due from Melt for reimbursable expenses and amounts payable pursuant to the Melt MSA, which are included
in prepaid expenses and other current assets in the accompanying consolidated balance sheets. As
of December 31, 2023 and 2022, the Company was due $ 228,000 and $ 139,000 , respectively, from Melt for reimbursable expenses and amounts
due under the Melt MSA. Melt did not make any payments to the Company during the year ended December 31, 2022. The Company made
a cash advance to Melt of $ 500,000 and Melt repaid the $ 500,000 cash advance during the year ended December 31, 2023.
During
the year ended December 31, 2023, Melt sold 2,421,904 shares of its Series B Preferred Stock and raised over $ 20,586,000 in gross proceeds
from third party investors.
The
Company’s Chief Executive Officer, Mark L. Baum, was previously a member of the Melt board of directors until his resignation during
the year ended December 31, 2021. Mr. Baum re-joined the Melt board of directors in January 2023. At the time Mr. Baum re-joined, the
Melt board of directors consisted of five members, including Mr. Baum, who is the only representative of the Company on Melt’s
board of directors.
Melt
Note Receivable – Settled and Terminated in 2023
On
September 1, 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 bore interest at 12.50 % per annum,
which interest could have been paid in-kind at the option of Melt until the maturity date. The Melt Loan Agreement permitted Melt to
pay interest only on the principal amount loaned thereunder through the term and all amounts owed were previously due and payable on
September 1, 2022. In April 2022, the Company entered into a First Amendment and in September 2022, a Second Amendment (together, the
“Amendments”) to the Melt Loan Agreement. The Amendments (i) extended the maturity date of the Melt Loan Agreement to September
1, 2023, which could have been extended further to September 1, 2026 upon Melt completing a qualifying financing of a minimum amount
of $ 10,000,000 from third-party investors, (ii) added conditions related to minimum cash amounts following a qualifying financing, and
(iii) clarified the definition of material adverse effects. Melt could have elected to prepay all, but not less than all, of the amounts
owed prior to the maturity date at any time without penalty. The net funds received by Melt excluded $ 908,000 owed to the Company for
reimbursable expenses and amounts due under the Melt MSA prior to the effective date of the note receivable.
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.
On
December 28, 2023, the Company terminated the Melt Loan Agreement. As of the date of termination, approximately $ 18,395,000 remained
outstanding under the Melt Loan Agreement. Pursuant to the terms of a Settlement and Payoff Agreement, dated as of December 28, 2023,
by and between the Company and Melt (the “Settlement Agreement”), the Company received 2,260,000 shares of Melt’s Series
B-1 Preferred Stock and 74,256 shares of Melt’s Series B Preferred Stock (which both series have similar rights and preferences)
in consideration for the full payment of all amounts outstanding under the Melt Loan Agreement. The Settlement Agreement contains customary
representations, warranties and releases of the parties and requires the parties to enter into a registration rights agreement providing
the Company with rights consistent with other holders of preferred stock of Melt. The Company concluded the Settlement Agreement is in
substance a funding of the Company’s share of prior unrecorded losses and, therefore, those suspended losses must be recognized
first against the value of the new preferred stock investments. This resulted in reducing the carrying value of the Company’s investment
in Melt, including the carrying value of the Preferred Stock received, to zero (the consideration received in the form of an equivalent
fair value of Melt’s Preferred Stock to settle the full outstanding note receivable balance of $ 18,400,000 is essentially offset
by an equal amount of the funding of prior unrecorded losses). Accordingly, this settlement transaction had no quantitative effect on
either the Company’s consolidated balance sheet or consolidated statement of operations for the year ended December 31, 2023.
F- 23
In
accordance with ASC 323, Investments – Equity Method and Joint Ventures , the carrying amount of the note receivable and
other investments in Melt have been reduced by the Company’s allocated share of Melt’s losses based on its ownership of Melt
and its total indebtedness (see Note 2).
The
unaudited condensed results of operations information of Melt is summarized below:
SCHEDULE
OF CONDENSED INCOME STATEMENT
For
the Years Ended
December 31,
2023
2022
Revenues, net
$ -
$ -
Loss from operations
$ ( 7,581,000 )
$ ( 12,443,000 )
Net loss
$ ( 11,271,000 )
$ ( 14,446,000 )
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE
OF CONDENSED BALANCE SHEET
December
31,
2023
2022
Current assets
$ 13,404,000
$ 655,000
Non-current assets
-
107,000
Total assets
$ 13,404,000
$ 762,000
Total liabilities
$ 3,922,000
$ 19,056,000
Total preferred stock
and stockholders’ equity (deficit)
9,482,000
( 18,294,000 )
Total liabilities
and stockholders’ equity
$ 13,404,000
$ 762,000
NOTE
6. INVESTMENT IN SURFACE OPHTHALMICS, INC. AND AGREEMENTS - 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 December 31, 2023, the Company owned 3,500,000 shares of Surface common stock. Adrienne Graves and Perry J. Sternberg, directors of
the Company, also are directors of Surface. Mark L. Baum, who is the Company’s Chief Executive Officer, was previously a member
of the Surface board of directors and resigned from his position as a director of Surface on March 31, 2023.
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 requirements to advance funds to Surface and no obligations to fund its future
operating losses, if any. Therefore, the Company’s future financial results will not be negatively affected by Surface’s
ongoing operations.
F- 24
NOTE
7. INVENTORIES
Inventories
are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, branded pharmaceutical
products, including those held at the Company’s 3PL partner, related laboratory supplies and active pharmaceutical ingredients.
The composition of inventories as of December 31, 2023 and 2022 was as follows:
SCHEDULE
OF INVENTORIES
December
31,
2023
2022
Raw materials
$ 5,477,000
$ 3,707,000
Work in progress
54,000
38,000
Finished goods
5,336,000
2,796,000
Total inventories
$ 10,867,000
$ 6,541,000
NOTE
8. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets at December 31, 2023 and 2022 consisted of the following:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
December
31,
2023
2022
Prepaid insurance
$ 1,241,000
$ 858,000
Prepaid computer software related expenses
1,613,000
1,165,000
Other prepaid expenses
906,000
937,000
Receivable due from Melt
228,000
139,000
Prepaid PDUFA fees
3,438,000
394,000
Deferred Oaktree commitment fee (see Note
13)
409,000
-
Deposits and other
current assets
1,753,000
118,000
Total
prepaid expenses and other current assets
$ 9,588,000
$ 3,611,000
NOTE
9. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment, net at December 31, 2023 and 2022 consisted of the following:
SCHEDULE
OF PROPERTY, PLANT AND EQUIPMENT
December
31,
2023
2022
Property, plant and equipment, net:
Computer
hardware
$ 1,322,000
$ 979,000
Furniture and equipment
936,000
860,000
Lab and pharmacy equipment
4,564,000
4,259,000
Leasehold
improvements
6,771,000
6,449,000
Property, plant and equipment,
gross
13,593,000
12,547,000
Accumulated depreciation
and amortization
( 10,072,000 )
( 9,061,000 )
Property,
plant and equipment, net
$ 3,521,000
$ 3,486,000
During
the years ended December 31, 2023 and 2022, the Company disposed of property, plant and equipment with a net book value of $ 168,000 and
$ 69,000 , respectively, related to the discontinued use of certain lab equipment, which is included in other expense, net in the consolidated
statements of operations. The Company recorded depreciation and amortization expense of $ 1,055,000 and $ 1,253,000 during the years ended
December 31, 2023 and 2022, respectively.
F- 25
NOTE
10. CAPITALIZED SOFTWARE COSTS
Capitalized
software costs at December 31, 2023 and 2022 consisted of the following:
SCHEDULE
OF CAPITALIZED SOFTWARE COSTS
December
31,
2023
2022
Capitalized software costs
Capitalized
internal-use software development costs
$ 2,780,000
$ 1,413,000
Acquired
third-party software license for internal-use
159,000
159,000
Total gross capitalized
software for internal-use
2,939,000
1,572,000
Accumulated amortization
( 1,268,000 )
( 793,000 )
Capitalized internal-use
software in process
467,000
1,333,000
Total capitalized software costs net
$ 2,138,000
$ 2,112,000
The
Company recorded amortization expense of $ 475,000 and $ 224,000 during the years ended December 31, 2023 and 2022, respectively.
NOTE
11. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at December 31, 2023 consisted of the following:
SCHEDULE
OF INTANGIBLE ASSETS
Amortization
Net
periods
Accumulated
Carrying
(in years)
Cost
amortization
Impairment
value
Patents
7 - 19 years
$ 984,000
$ ( 253,000 )
$ ( 276,000 )
$ 455,000
Licenses
7 - 20 years
100,000
( 30,000 )
( 22,000 )
48,000
Trademarks
Indefinite
281,000
-
( 82,000 )
199,000
Acquired NDAs
4 - 15 years
170,353,000
( 11,300,000 )
-
159,053,000
Customer relationships
3 - 15 years
596,000
( 516,000 )
-
80,000
Trade name
5 years
75,000
( 5,000 )
-
70,000
Non-competition clause
3 - 4 years
50,000
( 50,000 )
-
-
State pharmacy licenses
25 years
8,000
( 7,000 )
-
1,000
$ 172,447,000
$ ( 12,161,000 )
$ ( 380,000 )
$ 159,906,000
During
the year ended December 31, 2023, the Company recorded a charge of $ 380,000 related to the impairment of certain licenses, trademarks,
patents and patent applications. The Company determined that the sum of the expected undiscounted cash flows attributable to these intangible
assets was less than their carrying value and that an impairment charge was required. Accordingly, the Company calculated the estimated
fair value of the intangible assets based on the present value of the expected cash flows over their estimated lives. The impairment
amount was calculated by deducting the present value of the expected cash flows from the carrying value. Significant estimates and assumptions
used by the Company included sales and expense growth rates, and discounted projected cash flows. The estimates and assumptions used
in our assessment represent a Level 3 measurement because they are supported by little or no market activity and reflect the Company’s
own assumptions in measuring fair value. The assumptions used in the impairment analysis are inherently subject to uncertainty and, therefore,
changes in these assumptions could have a significant impact on the concluded fair value.
F- 26
The
Company’s intangible assets at December 31, 2022 consisted of the following:
Amortization
Net
periods
Accumulated
Carrying
(in years)
Cost
amortization
Sold
value
Patents
7 - 19 years
$ 980,000
$ ( 161,000 )
$ -
$ 819,000
Licenses
20 years
100,000
( 23,000 )
-
77,000
Trademarks
Indefinite
267,000
-
-
267,000
Acquired NDAs
10 years
23,720,000
( 1,363,000 )
-
22,357,000
Customer relationships
3 - 15 years
1,519,000
( 759,000 )
( 626,000 )
134,000
Trade name
5 years
75,000
( 5,000 )
-
70,000
Non-competition clause
3 - 4 years
50,000
( 50,000 )
-
-
State pharmacy licenses
25 years
8,000
( 7,000 )
-
1,000
$ 26,719,000
$ ( 2,368,000 )
$ ( 626,000 )
$ 23,725,000
During
the year ended December 31, 2022, the Company recorded a net reduction to customer relationships intangible assets of $ 626,000 related
to customer relationships that were associated with the non-ophthalmology assets sold by the Company. The amount was reflected net of
the gross proceeds received related to the sale of the Company’s non-ophthalmology assets (see Note 4).
See
Note 4 related to other intangible assets acquired and divested during the years ended December 31, 2023 and 2022.
Amortization
expense for intangible assets for the years ended December 31, 2023 and 2022 were as follows:
SCHEDULE
OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
For
the Years Ended
December 31,
2023
2022
Patents
$ 84,000
$ 86,000
Licenses
7,000
16,000
Acquired NDAs
9,937,000
1,363,000
Customer relationships
54,000
113,000
Amortization of intangible
assets
$ 10,082,000
$ 1,578,000
Estimated
future amortization expense for the Company’s intangible assets at December 31, 2023 is as follows:
SCHEDULE
OF ESTIMATED FUTURE AMORTIZATION EXPENSE
Years ending
December 31,
2024
$ 13,658,000
2025
13,658,000
2026
13,658,000
2027
13,309,000
2028
12,961,000
Thereafter
92,463,000
Intangible assets
$ 159,707,000
There
were no changes in the carrying value of the Company’s goodwill during the years ended December 31, 2023 and 2022.
NOTE
12. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses at December 31, 2023 and 2022 consisted of the following:
SCHEDULE
OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
2023
2022
December
31,
2023
2022
Accounts payable
$ 21,424,000
$ 6,440,000
Accrued insurance premium
873,000
575,000
Accrued IHEEZO milestone payments (see Note
4)
-
5,000,000
Accrued RPC transition payments (see Note
4)
57,000
453,000
Accrued exit fee for note payable (see Note
13)
2,713,000
-
Accrued litigation settlements
249,000
49,000
Accrued interest
(see Note 13)
1,978,000
1,254,000
Total accounts payable and accrued expenses
$ 27,294,000
$ 13,771,000
Less: current portion
( 24,581,000 )
( 13,771,000 )
Non-current total
accrued expenses
$ 2,713,000
$ -
F- 27
The
Company financed all insurance policies for the policy terms of August 17, 2023 through August 16, 2024 and August 17, 2022 through August
16, 2023. The financing agreements have an interest rate of 7.48 % and 4.13 % per annum, respectively, and require nine monthly payments
of $ 169,000 and eight monthly payments of $ 114,000 , respectively.
NOTE
13. DEBT
Oaktree
Loan Due 2026
In
March 2023, the Company entered into a Credit Agreement and Guaranty, (the “Oaktree Loan”) with Oaktree Fund Administration,
LLC, as administrative agent for the lenders (together, “Oaktree”), providing for a senior secured term loan facility to
the Company with a principal amount of up to $ 100,000,000 . Upon entering into the Oaktree Loan, the Company drew a principal amount of
$ 65,000,000 (“Tranche A”) from the Oaktree Loan and used the net proceeds to repay all amounts owed by the Company pursuant
to the Loan and Security Agreement the Company previously entered into with B. Riley Commercial Capital, LLC on December 14, 2022 (the
“B. Riley Loan”) – see subheading B. Riley Loan and Security Agreement – Paid in Full within this Note
13. The additional principal loan amount of up to $ 35,000,000 available under the Oaktree Loan (“Tranche B”) will be made
available to the Company upon the commercialization of TRIESENCE. If Tranche B is not drawn by the Company on or before March 27, 2024,
the amount available under Tranche B will be decreased to $ 30,000,000 . While undrawn, the Company is required to pay a commitment fee
related to Tranche B amount equal to 2 % per annum, payable quarterly. This fee is recorded within prepaid expenses and other current
assets and is being amortized on a straight-line basis over the access period.
The
Oaktree Loan is secured by nearly all of the assets, including intellectual property, of the Company and its material subsidiaries. The
Oaktree Loan has a maturity date of January 19, 2026 and carries an interest rate equal to the Secured Overnight Financing Rate plus
6.5 % per annum (totaling 11.83 % at December 31, 2023). From proceeds, the Company paid fees, offering expenses, and the Oaktree Loan
was issued at an original issue discount, resulting in an aggregate discount of $ 3,415,000 . The Oaktree Loan also carries an exit fee
equal to 3.5 % of the aggregate principal amount owed, payable at maturity, and the Company accrued $ 2,275,000 related to the exit fee.
The original issue discount, fees and expenses (including the exit fee) are being amortized over the term of the Oaktree Loan using the
effective interest rate method. The Oaktree Loan requires quarterly interest-only payments with all of the unpaid principal, interest
and fees due on the maturity date, January 19, 2026.
In
July 2023, the Company entered into the First Amendment to the Oaktree Loan (the “Oaktree Amendment”). Under the Oaktree
Amendment, the overall credit facility size was increased from $ 100,000,000 to $ 112,500,000 , and the Company made other changes related
to the Santen Products Acquisition (see Note 4). Upon satisfaction of certain conditions to funding, the Company drew down a principal
amount of $ 12,500,000 (the “Loan Increase”) to fund the initial one-time payment associated with the Santen Products Acquisition
and for other working capital and general corporate purposes. No other material changes to the Oaktree Loan were made pursuant to the
Oaktree Amendment. Following entry into the Oaktree Amendment and the funding of the Loan Increase upon closing of the Santen Products
Acquisition, the Company has drawn down a total principal loan amount of $ 77,500,000 under the Oaktree Loan. The Oaktree Loan exit fee
was increased from $ 2,275,000 to $ 2,713,000 pursuant to the Oaktree Amendment. As of December 31, 2023, the Company has recorded in accrued
expenses the total exit fee liability of $ 2,713,000 .
The
Oaktree Loan contains customary guarantees and covenants, including financial covenants related to minimum liquidity and minimum net
revenues. As of December 31, 2023, the Company was in compliance with the financial covenants. As of the end of the fiscal quarter ending
December 31, 2024, if the Company’s Total Leverage Ratio (as defined in the Oaktree Loan) is greater than or equal to five times,
but less than seven times, the Company will be required to issue to Oaktree warrants to purchase 375,000 shares of the Company’s
common stock, and if the Total Leverage Ratio is greater than or equal to seven times, the Company will be required to issue to Oaktree
warrants to purchase an additional 375,000 shares of the Company’s common stock (equaling 750,000 shares in aggregate). If the
Total Leverage Ratio as of the end of the fiscal quarter ending December 31, 2024 is less than five times, no warrants will be issued
to Oaktree. Based on current projections, the Company does not expect to issue any warrants related to the Oaktree Loan.
F- 28
Interest
expense related to the Oaktree Loan totaled $ 8,804,000 for the year ended December 31, 2023, and included the amortization of debt issuance
costs and discount of $ 1,680,000 and amortization of deferred commitment fees of $ 543,000 .
HROWM
- 11.875% Senior Notes Due 2027
In
December 2022 and in January 2023, the Company closed an offering of $ 35,000,000 and $ 5,250,000 , respectively, aggregate principal amount
of 11.875 % senior notes due in December 2027 (the “2027 Notes”). The 2027 Notes were sold to investors at a par value of
$ 25.00 per 2027 Note, and the offering resulted in net proceeds to the Company of approximately $ 36,699,000 after deducting underwriting
discounts and commissions and other offering expenses of $ 3,551,000 .
The
2027 Notes are senior unsecured obligations of the Company and rank equally in right of payment with all of the Company’s other
existing and future senior unsecured and unsubordinated indebtedness. The 2027 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 2027 Notes bear interest at the rate of 11.875 % per annum. Interest
on the 2027 Notes is payable quarterly in arrears on January 31, April 30, July 31 and October 31 of each year, commencing on January
31, 2023. The 2027 Notes will mature on December 31, 2027 . The issuance costs were recorded as a debt discount and are being amortized
as interest expense over the term of the 2027 Notes using the effective interest rate method .
At
any time prior to December 31, 2024, the Company may, at its option, redeem the 2027 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 2027 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 2027 Notes for cash in whole or
in part at any time at its option (i) on or after December 31, 2024 and prior to December 31, 2025, at a price equal to $25.50 per note,
plus accrued and unpaid interest to, but excluding, the date of redemption, (ii) on or after December 31, 2025 and prior to December
31, 2026, at a price equal to $25.25 per note, plus accrued and unpaid interest to, but excluding, the date of redemption, and (iii)
on or after December 31, 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. In addition, the Company is required to redeem the 2027 Notes, for cash, in whole but not
in part, at the price of $25.50 per note, plus accrued and unpaid interest to, but excluding, the date of redemption, upon occurrence
of certain events including the occurrence of a Material Change, as defined in the Second Supplemental Indenture. The 2027 Notes trade
on the Nasdaq Stock Market LLC under the symbol “HROWM.”
Interest
expense related to the 2027 Notes totaled $ 5,516,000 and $ 140,000 for the years ended December 31, 2023 and 2022, respectively, and included
the amortization of debt issuance costs and discount of $ 736,000 and $ 0 , respectively.
Our
Chief Executive Officer, Mark L. Baum, Chief Financial Officer, Andrew R. Boll, and former directors R. Lawrence Van Horn and Dr. Richard
Lindstrom, in the aggregate, purchased $ 950,000 in principal amount of the 2027 Notes at the time of their offering.
F- 29
HROWL
– 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 other offering expenses of $ 3,091,000 . In September 2021, in a further issuance of the April Notes, the Company sold an additional
$ 20,000,000 aggregate principal amount of such notes (the “September Notes,” and together with the April Notes, the “2026
Notes”), at a price of $ 25.75 per September Note, with interest of $ 278,000 on the September Notes being accrued from April 20,
2021, the date of issuance of the April Notes. The September offering resulted in net proceeds to the Company of approximately $ 19,164,000
after deducting underwriting discounts and commissions and other offering expenses of $ 1,158,000 and a premium on note issuance of $ 322,000 .
The September 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 2026 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 2026 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 2026 Notes bear interest at a rate of 8.625 % per annum. Interest on the 2026 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 2026 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 2026 Notes using the effective interest rate method .
Prior
to February 1, 2026, the Company may, at its option, redeem the 2026 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 2026 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 2026 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.
The 2026 Notes trade on the Nasdaq Stock Market LLC under the symbol “HROWL”.
Interest
expense related to the 2026 Notes totaled $ 7,251,000 and $ 7,238,000 for the years ended December 31, 2023 and 2022, respectively, and
included amortization of debt issuance costs and discount of $ 782,000 , and $ 782,000 for the years ended December 31, 2023 and 2022, respectively.
B.
Riley Loan and Security Agreement – Paid in Full
On
December 14, 2022 (the “Effective Date”), the Company entered into a Loan and Security Agreement (the “BR Loan”)
with B. Riley Commercial Capital, LLC, as administrative agent for the lenders. The BR Loan provided for a loan facility of up to $ 100,000,000
to the Company with a maturity date of December 14, 2025 (the “Maturity Date”), at an interest rate of 10.875 % per annum.
In
January 2023, $ 59,750,000 of principal amount was funded pursuant to the BR Loan simultaneously with the consummation of the NVS 5 Acquisition
(see Note 4). In March 2023, the Company repaid all amounts owed under the BR Loan, in connection with the Oaktree Loan, and no exit
or prepayment fees were paid as a result of the payoff of the BR Loan pursuant to a side letter agreement among the parties.
Interest
expense related to the BR Loan totaled $ 1,565,000 for the year ended December 31, 2023, and included amortization of debt issuance costs
and debt discount of $ 356,000 . The Company recorded a loss of $ 5,465,000 related to the early extinguishment of debt associated with
the BR Loan.
A
summary of the Company’s debt at December 31, 2023 and 2022 is described as follows:
SCHEDULE
OF LONG TERM DEBT
December 31,
December 31,
2023
2022
8.625% Senior Notes due April 2026
$ 75,000,000
$ 75,000,000
11.875% Senior Notes due December 2027
40,250,000
35,000,000
Oaktree Loan due January
2026
77,500,000
-
Notes payable gross
192,750,000
110,000,000
Less: Unamortized debt
discount and issuance costs
( 9,578,000 )
( 5,826,000 )
Notes payable net
$ 183,172,000
$ 104,174,000
F- 30
For
the years ended December 31, 2023 and 2022, the total effective interest rate of the Company’s debt was 10.93 %, and 8.97 %, respectively .
At
December 31, 2023, future minimum payments under the Company’s debt were as follows:
SCHEDULE
OF FUTURE MINIMUM PAYMENT UNDER NOTES PAYABLES
Amount
2024
$ 21,201,000
2025
20,590,000
2026
159,896,000
2027
45,030,000
Total minimum payments
246,717,000
Less: amount representing
interest payments
( 53,967,000 )
Notes payable, gross
192,750,000
Less: unamortized discount,
net of premium
( 9,578,000 )
Notes payable, net of
unamortized discount
$ 183,172,000
NOTE
14. LEASES
The
Company leases office and laboratory space under the 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 that expires in March
2025 .
●
An
operating lease for 38,153 square feet of lab, warehouse and office space in Ledgewood, New Jersey that expires in July 2027 , with
an option to extend the term for two additional five-year periods. This lease was amended, effective July 2020, to extend the term
of the original lease and add 1,400 of additional square footage to the lease, amended again in May 2021 to extend the term of the
lease to July 2027 and add 8,900 square feet of space, and amended in May 2023 to add another 2,861 square feet of space to the existing
lease, which the Company took possession of in January 2024.
●
An
operating lease for 5,500 square feet of office space in Nashville, Tennessee that expires in December 2024 .
●
An
operating lease for 11,552 square feet of lab and office space in Nashville, Tennessee which commenced in September 2022 and expires
in September 2027 .
At
December 31, 2023 and 2022, the weighted-average discount rate and the weighted-average remaining lease term for the operating leases
held by the Company were 6.6 % and 6.6 % and 10.4 years and 10.9 years, respectively.
During
the years ended December 31, 2023 and 2022, cash paid for amounts included for the operating lease liabilities was $ 1,231,000 and $ 925,000 ,
respectively, and the Company recorded operating lease expense of $ 1,232,000 and $ 1,117,000 , respectively, included in selling, general
and administrative expenses.
Future
lease payments under operating leases as of December 31, 2023 were as follows (excluding lease transactions entered into in 2024) :
SCHEDULE
OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES
Operating
Leases
2024
$ 1,261,000
2025
1,093,000
2026
1,114,000
2027
972,000
2028
657,000
Thereafter
5,173,000
Total minimum lease payments
10,270,000
Less: amount representing
imputed interest payments
( 2,940,000 )
Total operating lease liabilities
7,330,000
Less: current portion,
operating lease liabilities
( 806,000 )
Operating lease obligations,
net of current portion
$ 6,524,000
F- 31
NOTE
15. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Preferred
Stock
At
December 31, 2023 and 2022, 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
At
each of December 31, 2023 and 2022, the Company had 50,000,000 shares of common stock, $ 0.001 par value, authorized.
Issuances
During the Year Ended December 31, 2023
During
the year ended December 31, 2023:
●
the
Company closed a public offering of shares of its common stock at an offering price of $ 17.75 per share (the “Offering”).
The Company sold 3,887,324 shares of its common stock in the Offering, resulting in the Company receiving aggregate net proceeds
of $ 64,520,000 , after deducting underwriting discounts and commissions and other offering expenses of $ 4,480,000 ;
●
the
Company settled 1,567,913 outstanding PSUs as a result of the achievement of the total stockholder returns (“TSR”) targets
set forth in equity incentive awards (the “PSU Agreements”) previously issued to members of the Company’s management
team in 2021 (the “2021 Awards”). The 2021 Awards were separated into four tranches and required that the Company achieve
and maintain certain levels of TSR ranging from 50 % to 175 % per share during the five-year period following the grant date. TSR was
based on the aggregate of: (i) the percent increase of the closing price of the Company’s common stock from July 22, 2021;
and (ii) any dividends or like stockholder distributions as specified in the PSU Agreements. In connection with the settlement of
the 2021 Awards, an aggregate of 616,984 shares of the Company’s common stock was withheld by Harrow for payroll tax obligations
totaling $ 11,273,000 ;
●
the
Company issued 168,963 shares of its common stock underlying RSUs held by directors that ceased providing services to the Company.
The RSUs had previously vested, including 21,620 RSUs during the year ended December 31, 2023, but the issuance and delivery of the
shares were deferred until the director ceased providing services to the Company;
●
the
Company issued 65,148 shares of common stock and received proceeds of $ 379,000 upon the exercise of options to purchase 65,148 shares
of common stock with exercise prices ranging from $ 1.70 to $ 8.50 per share;
●
the
Company issued 62,367 shares of common stock to Mark L. Baum, the Company’s Chief Executive Officer, upon the cashless exercise
of options to purchase 180,000 shares at an exercise price of $ 8.99 per share. The Company withheld from Mr. Baum 77,167 shares as
consideration for the cashless exercise and an additional 40,466 shares for payroll tax obligations totaling $ 849,000 ;
F- 32
●
the
Company issued 55,558 shares of common stock to Andrew R. Boll, the Company’s Chief Financial Officer, upon the cashless exercise
of options to purchase 90,000 shares at an exercise price of $ 6.00 per share. The Company withheld from Mr. Boll 25,521 shares as
consideration for the cashless exercise and an additional 8,921 shares for payroll tax obligations totaling $ 189,000 ;
●
the
Company issued 10,222 shares of common stock to John Saharek, the Company’s Chief Commercial Officer, upon the cashless exercise
of options to purchase 20,000 shares at an exercise price of $ 4.16 per share. The Company withheld from Mr. Saharek 6,485 shares
as consideration for the cashless exercise and an additional 3,293 shares for payroll tax obligations totaling $ 41,000 ;
●
upon
vesting of 23,000 RSUs granted in January 2020 to Andrew R. Boll, the Company’s Chief Financial Officer, the Company issued
13,398 shares of common stock to Mr. Boll, net of 9,602 shares of common stock withheld for payroll tax withholdings totaling $ 142,000 ;
●
upon
vesting of 88,000 RSUs granted in January 2020 to Mark L. Baum, the Company’s Chief Executive Officer, the Company issued 52,821
shares of common stock to Mr. Baum, net of 35,179 shares of common stock withheld for payroll tax withholdings totaling $ 519,000 ;
and
●
43,023
shares of the Company’s common stock underlying RSUs issued to directors vested, but the issuance and delivery of these shares
were deferred until the applicable director ceased providing services to the Company.
Issuances
During the Year Ended December 31, 2022
During
the year ended December 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 ;
●
the
Company issued 306,347 shares of its common stock upon the cashless exercise of warrants to purchase 373,847 shares of common stock
with an exercise price of $ 2.08 per share;
●
the
Company issued 4,054 shares of common stock to a consultant upon the cashless exercise of options to purchase 15,995 shares at an
exercise price of $ 7.07 per share. The Company withheld 11,941 shares as consideration for the cashless exercise ;
●
the
Company issued 15,625 shares of common stock to a consultant and received net proceeds of $ 55,000 upon the exercise of options to
purchase 15,625 shares of common stock at an exercise price of $ 3.50 per share ;
●
the
Company issued 132,100 shares of common stock and received net proceeds of $ 587,000 upon the exercise of options to purchase 132,100
shares of common stock with exercise prices between $ 1.70 to $ 8.40 per share ;
●
185,000
RSUs granted at various dates to employees of the Company vested, and the Company issued 110,621 shares of common stock to the employees,
net of 74,379 shares of common stock withheld for payroll tax withholdings totaling $ 581,000 ; and
●
35,693
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 .
F- 33
Stock
Option Plan
On
September 17, 2007, the Company’s Board of Directors and stockholders adopted the Company’s 2007 Incentive Stock and Awards
Plan, which was subsequently amended on November 5, 2008, February 26, 2012, July 18, 2012, May 2, 2013 and September 27, 2013 (as amended,
the “2007 Plan”). The 2007 Plan reached its term in September 2017, and we can no longer issue additional awards under this
plan, however, options previously issued under the 2007 Plan will remain outstanding until they are exercised, reach their maturity or
are otherwise cancelled/forfeited. On June 13, 2017, the Company’s Board of Directors and stockholders adopted the Company’s
2017 Incentive Stock and Awards Plan which was subsequently amended on June 3, 2021 (as amended, the “2017 Plan” together
with the 2007 Plan, the “Plans”). As of December 31, 2023, the 2017 Plan provides for the issuance of a maximum of 6,000,000
shares of the Company’s common stock. The purpose of the Plans are to attract and retain directors, officers, consultants, advisors
and employees whose services are considered valuable, to encourage a sense of proprietorship and to stimulate an active interest of such
persons in the Company’s development and financial success. Under the Plans, the Company is authorized to issue incentive stock
options intended to qualify under Section 422 of the Internal Revenue Code of 1986, as amended, non-qualified stock options, restricted
stock units and restricted stock. The Plans are administered by the Compensation Committee of the Company’s Board of Directors.
The Company had 405,612 shares available for future issuances under the 2017 Plan at December 31, 2023.
Stock
Options
A
summary of stock option activity under the Plan for the year ended December 31, 2023 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, 2023
3,027,701
$ 5.90
Options granted
135,500
$ 17.81
Options exercised
( 355,148 )
$ 7.36
Options cancelled/forfeited
( 96,736 )
$ 7.49
Options outstanding
– December 31, 2023
2,711,317
$ 6.25
4.00
$ 14,303,000
Options exercisable
2,432,826
$ 5.55
3.45
$ 13,760,000
Options vested and
expected to vest
2,673,670
$ 6.15
3.93
$ 14,243,000
A
summary of stock option activity under the Plan for the year ended December 31, 2022 is as follows:
Number
of shares
Weighted
Avg.
Exercise
Price
Weighted
Avg. Remaining
Contractual
Life
Aggregate
Intrinsic
Value
Options outstanding –
January 1, 2022
3,039,546
$ 5.52
Options granted
351,250
$ 7.71
Options exercised
( 288,720 )
$ 3.65
Options cancelled/forfeited
( 74,375 )
$ 7.46
Options outstanding
– December 31, 2022
3,027,701
$ 5.90
4.48
$ 26,822,000
Options exercisable
2,457,769
$ 5.51
3.97
$ 22,731,000
Options vested and
expected to vest
3,026,942
$ 5.90
4.48
$ 26,817,000
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 options with an exercise price lower
than the market price on December 31, 2023 and 2022, based on the closing price of the Company’s common stock of $ 11.20 and $ 14.76 ,
respectively, on that date.
The
intrinsic value of the options exercised in 2023 and 2022 was $ 4,580,000 and $ 2,008,000 , respectively.
F- 34
During
the year ended December 31, 2023, the Company granted stock options to certain employees. The stock options were granted with an exercise
price equal to the current market price of the Company’s common stock, as reported by the securities exchange on which the common
stock was then listed, at the grant date and have contractual terms of 10 years. Vesting terms for options granted to employees during
the year ended December 31, 2023 generally included one of the following vesting schedules: 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; and 100% of the shares subject to the option vest on
a quarterly basis in equal installments 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 Company calculates
expected volatility based solely on the historical volatilities of the common stock of the Company. The expected term of options granted
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
2023
2022
Weighted-average fair value of
options granted
$ 11.49
$ 4.72
Expected terms (in years)
6.11
6.11
Expected volatility
68
– 70 %
68
– 72 %
Risk-free interest rate
3.59
– 4.80 %
1.54
– 3.70 %
Dividend yield
-
-
The
following table summarizes information about stock options outstanding and exercisable at December 31, 2023:
SCHEDULE OF STOCK
OPTION OUTSTANDING AND EXERCISABLE
Options
Outstanding
Options
Exercisable
Range
of
Exercise
Prices
Number
Outstanding
Weighted
Average
Remaining
Contractual
Life in Years
Weighted
Average
Exercise
Price
Number
Exercisable
Weighted
Average
Exercise
Price
$ 1.47
- $ 1.73
295,852
3.95
$ 1.72
295,852
$ 1.72
$ 2.23
285,000
3.09
$ 2.23
285,000
$ 2.23
$ 2.40
- $ 2.60
24,068
3.02
$ 2.58
24,068
$ 2.58
$ 3.95
310,000
2.25
$ 3.95
310,000
$ 3.95
$ 4.49
- $ 5.72
100,225
5.47
$ 5.54
94,416
$ 5.53
$ 6.30
285,000
5.14
$ 6.30
285,000
$ 6.30
$ 6.75
- $ 7.26
103,312
8.04
$ 6.96
39,625
$ 6.96
$ 7.30
274,500
6.01
$ 7.30
274,500
$ 7.30
$ 7.37
- $ 7.79
229,187
3.99
$ 7.52
172,818
$ 7.50
$ 7.87
- $ 25.86
804,173
3.27
$ 9.59
651,547
$ 7.93
$ 1.47
- $ 25.86
2,711,317
4.00
$ 6.25
2,432,826
$ 5.55
F- 35
As
of December 31, 2023, there was approximately $ 1,966,000 of total unrecognized compensation expense related to unvested stock options
granted under the Plan. That expense is expected to be recognized over the weighted-average remaining vesting period of 2.77 years. The
stock-based compensation for all stock options was $ 782,000 and $ 1,130,000 during the years ended December 31, 2023 and 2022, respectively.
Performance
Stock Units
Grants
During the Year Ended December 31, 2023
In
April 2023, the Company granted an aggregate of 1,567,913 PSUs to members of its senior management including Mark Baum, Chief Executive
Officer, Andrew Boll, Chief Financial Officer, and John Saharek, Chief Commercial Officer, which are subject to the satisfaction of certain
market-based and continued service conditions (the “2023 PSUs”). The vesting of the 2023 PSUs require (i) a minimum of a
two-year service period, and (ii) during a five-year term, the achievement and maintenance of Company common stock price targets for
ten consecutive trading days ranging between $ 25.00 to $ 50.00 per share, separated into four separate tranches as described further in
the table below.
SCHEDULE
OF PERFORMANCE STOCK UNITS
Tranche
Number of Shares
Target Share Price*
Tranche 1
223,988
$ 25.00
Tranche 2
335,981
$ 35.00
Tranche 3
447,975
$ 45.00
Tranche 4
559,969
$ 50.00
*
Target
Share Price assumes that no dividends or like distributions are made to stockholders of the Company. If such distributions are made,
the Target Share Price would decrease accordingly, to the benefit of the employee, to account for the dividend/distribution as a
part of the Target Share Price.
The
aggregate fair value of the 2023 PSUs was $ 29,106,000 using a Monte Carlo Simulation with a five-year life, 65 % volatility and a risk
free interest rate of 10.34 %. This amount is being amortized over a two-year derived service period.
A
summary of the Company’s PSU activity and related information for the year ended December 31, 2023 is as follows:
SCHEDULE
OF PERFORMANCE STOCK UNITS ACTIVITY
Number
of PSUs
Weighted
Average Grant Date Fair Value
PSUs unvested – January 1, 2023
1,567,913
$ 6.45
PSUs granted
1,567,913
$ 18.56
PSUs vested
( 1,567,913 )
$ 6.45
PSUs cancelled/forfeited
-
$ -
PSUs unvested – December 31, 2023
1,567,913
$ 18.56
Grants
During the Year Ended December 31, 2022
No
PSUs were issued during the year ended December 31, 2022. A summary of the Company’s PSU
activity and related information for the year ended December 31, 2022 is as follows:
Number
of PSUs
Weighted
Average Grant
Date Fair Value
PSUs unvested – January 1, 2022
1,567,913
$ 6.45
PSUs granted
-
-
PSUs vested
-
-
PSUs cancelled/forfeited
-
-
PSUs unvested – December 31, 2022
1,567,913
$ 6.45
F- 36
As
of December 31, 2023, the total unrecognized compensation expense related to unvested PSUs was approximately $ 18,191,000 which is expected
to be recognized over a weighted-average period of 1.26 years, based on estimated vesting schedules. The stock-based compensation for
PSUs was $ 13,753,000 and $ 5,056,000 during the years ended December 31, 2023 and 2022, respectively.
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.
Grants
During the Year Ended December 31, 2023
During
the year ended December 31, 2023, the Company’s board of directors were granted 41,301 time-based vesting RSUs with a fair market
value of $ 800,000 , which vest in equal quarterly installments over one year. The Company also granted 86,873 time-based vesting RSUs
with a fair market value of $ 697,000 to certain employees, which vest in full on the third anniversary of the grant date.
A
summary of the Company’s RSU activity and related information for the year ended December 31, 2023 is as follows:
SCHEDULE
OF RESTRICTED STOCK UNITS ACTIVITY
Number
of RSUs
Weighted
Average
Grant
Date
Fair Value
RSUs unvested – January
1, 2023
493,806
$ 7.99
RSUs granted
128,174
$ 11.68
RSUs vested
( 175,643 )
$ 8.67
RSUs cancelled/forfeited
( 83,308 )
$ 6.84
RSUs unvested at
December 31, 2023
363,029
$ 9.23
Grants
During the Year Ended December 31, 2022
During
the year ended December 31, 2022, the Company’s board of directors were granted 65,615 RSUs with a fair market value of $ 500,000 ,
which vest in equal quarterly installments over one year.
A
summary of the Company’s RSU activity and related information for the year ended December 31, 2022 is as follows:
Number
of RSUs
Weighted
Average
Grant
Date
Fair Value
RSUs unvested – January
1, 2022
665,288
$ 7.57
RSUs granted
65,615
$ 7.62
RSUs vested
( 237,098 )
$ 6.67
RSUs cancelled/forfeited
-
$ -
RSUs unvested at
December 31, 2022
493,806
$ 7.99
As
of December 31, 2023, the total unrecognized compensation expense related to unvested RSUs was approximately $ 1,234,000 which is expected
to be recognized over a weighted-average period of 0.68 years, based on estimated vesting schedules. The stock-based compensation for
RSUs was $ 1,161,000 and $ 1,788,000 during the years ended December 31, 2023 and 2022, respectively.
F- 37
The
Company recorded total stock-based compensation (including issuance of common stock for services and accrual for stock-based compensation)
related to equity instruments granted to employees, directors and consultants as follows:
SCHEDULE
OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES, DIRECTORS AND CONSULTANTS
2023
2022
For the Year
Ended December 31,
2023
2022
Employees – selling, general
and administrative
$ 13,279,000
$ 6,669,000
Employees – R&D
1,662,000
689,000
Directors – selling, general and administrative
688,000
462,000
Consultants –
selling, general and administrative
67,000
154,000
Total
$ 15,696,000
$ 7,974,000
NOTE
16. INCOME TAXES
The
Company is subject to taxation in the United States, California, New Jersey, Tennessee and various other states. The Company’s income tax provision consists of the following for the years ended December
31, 2023 and 2022 are summarized below:
SCHEDULE
OF PROVISION FOR INCOME TAXES
2023
2022
December
31,
2023
2022
Current:
Federal
$ -
$ -
State
701,000
75,000
Total current
701,000
75,000
Deferred:
Federal
-
-
State
-
-
Total deferred
-
-
Income tax provision
$ 701,000
$ 75,000
A
reconciliation of income taxes computed by applying the statutory U.S. income tax rate to the Company’s loss before income tax provision
to the income tax provision is as follows:
SCHEDULE
OF INCOME TAX PROVISION
2023
2022
December
31,
2023
2022
U.S. federal statutory tax rate
21.00 %
21.00 %
State tax benefit, net
0.77 %
( 2.82 )%
Rate change
( 8.02 )%
- %
Employee stock-based compensation
19.93 %
1.34 %
Excess employee remuneration
( 30.83 )%
( 28.15 )%
Melt loan settlement
( 4.52 )%
- %
Other
( 0.43 )%
( 0.18 )%
Uncertain tax positions
( 11.71 )%
- %
Research and development tax credit
0.53 %
- %
Provision-to-return true-ups
1.72 %
2.06 %
Other true-ups
2.97 %
- %
Change in valuation
allowance
5.71 %
6.22 %
Effective income
tax rate
( 2.88 )%
( 0.53 )%
F- 38
Deferred
tax assets and liabilities reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities
for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred
tax assets are as follows:
SCHEDULE
OF DEFERRED TAX ASSETS AND LIABILITIES
2023
2022
December
31,
2023
2022
Deferred tax assets (liabilities):
NOL
$ 4,669,000
$ 9,401,000
Depreciation and amortization
1,637,000
2,387,000
Other
854,000
349,000
Research and development
credits
220,000
90,000
Deferred stock compensation
1,059,000
945,000
Basis difference in
Eton
( 583,000 )
( 1,684,000 )
Basis difference in
Melt investments
3.405,000
4,240,000
Federal benefit of state
ASC740-10 reserves
88,000
-
Limitation Under 163(j)
2,893,000
536,000
Section 174 capitalized
expenses
1,261,000
594,000
ASC 842 lease liability
1,710,000
2,427,000
ASC
842 ROU asset
( 1,582,000 )
( 2,263,000 )
Total
deferred tax assets, net
15,631,000
17,022,000
Valuation allowance
( 15,631,000 )
( 17,022,000 )
Net deferred tax
assets
$ -
$ -
Realization
of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, the net
deferred tax assets have been fully offset by a valuation allowance. The valuation allowance decreased by approximately $ 1,391,000 and
$ 1,182,000 during 2023 and 2022, respectively.
As
of December 31, 2023, the Company had federal and state net operating loss carryforwards of approximately $ 8,596,000 and $ 26,134,000 ,
respectively, which will begin to expire in 2036 , unless previously utilized, and will begin to expire for state purposes in 2028. In
addition, the Company has federal net operating loss carryforward of $4,936,000 generated after 2017 that can be carried over indefinitely
and may be used to offset up to 80% of federal taxable income .
As
of December 31, 2023 the Company had federal and state research and development credit carryforwards of approximately $ 177,000 and $ 54,000 ,
respectively, which will begin to expire in 2031 , unless previously utilized. For state purposes, the state research and development
credit carryforwards can be carried over indefinitely.
Utilization
of the net operating losses and research and development carryforwards may be subject to a substantial annual limitation due to ownership
change limitations that might have occurred or that could occur in the future, as required by Section 382 of the Internal Revenue Code
of 1986, as amended (the “Code”), as well as similar state and foreign provisions. These ownership changes may limit the
amount of NOL and R&D credit carryforward that can be utilized annually to offset future taxable income and tax. Respectively. In
general, an “ownership change” as defined by Section 382 of the Code results from a transaction or series of transactions
over a three-year period resulting in an ownership change of more than 50 percentage points of the outstanding stock of a company by
certain stockholders or public groups. Since the Company’s formation, the Company has raised capital through the issuance of capital
stock on several occasions which, combined with the purchasing stockholders’ subsequent disposition of those shares, may have resulted
in such an ownership change, or could result in an ownership change in the future upon subsequent disposition.
As
of December 31, 2023, the Company determined that it had net operating loss carryforwards of approximately $ 12,500,000
and state net operating loss carryforwards of approximately $ 9,400,000
restricted under IRC Section 382 of the Internal Revenue Code related to a 2011 change in ownership. Section 382 of the Internal
Revenue Code limits the utilization of net operating losses when ownership changes, as defined by that section, occur. Due to the
Section 382 limitation, and the length of time available to fully utilize the net operating loss carryforwards, the Company removed
these NOLs from deferred tax assets with a corresponding reduction of the valuation allowance. Similarly, under IRC Section 383
which limits the utilization of credits when ownership changes occur, the Company removed approximately $ 300,000
of federal credit and $ 300,000
of state credits from deferred tax assets with a corresponding reduction of the valuation allowance.
F- 39
As
of December 31, 2023, the Company had approximately $ 2,853,000
of unrecognized tax benefits of which $ 2,853,000
if fully recognized, would decrease its effective
tax rate. There were interest or penalties accrued of $ 40,000
relating to unrecognized tax benefits as of December
31, 2023.
A
reconciliation of the change in the unrecognized tax benefits balance from January 1, 2023 to December 31, 2023 is as follows:
SCHEDULE
OF UNRECOGNIZED TAX BENEFITS
Federal
& State Tax
Balance at January 1, 2023
$ -
Additions for tax positions
related to current year
36,000
Additions for tax positions
related to prior years
2,817,000
Balance at December
31, 2023
$ 2,853,000
NOTE
17. EMPLOYEE SAVINGS PLAN
The
Company has established an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code, effective January 1, 2014.
The plan allows participating employees to deposit into tax deferred investment accounts up to 100 % of their salary, subject to annual
limits. The Company makes certain matching contributions to the plan in amounts up to 4 % of the participants’ annual cash compensation,
subject to annual limits. The Company contributed approximately $ 594,000 and $ 397,000 to the plan during the years ended December 31,
2023 and 2022, respectively.
NOTE
18. COMMITMENTS AND CONTINGENCIES
Legal
General
and Other
In
the ordinary course of business, the Company is involved in various legal proceedings, government investigations and other matters that
are complex in nature and have outcomes that are difficult to predict. See also Part I, Item 1A. Risk Factors . The Company describes
legal proceedings and other matters that are/were significant or that it believes could become significant in this footnote.
The
Company records accruals for loss contingencies to the extent that it concludes it is probable that a liability has been incurred and
the amount of the related loss can be reasonably estimated. The Company evaluates, on a quarterly basis, developments in legal proceedings
and other matters that could cause an increase or decrease in the amount of a liability that has been accrued previously.
The
Company’s legal proceedings involve various aspects of its business and a variety of claims, some of which present novel factual
allegations and/or unique legal theories. Typically, a number of the matters pending against the Company are at early stages of the legal
process, which in complex proceedings of the sort the Company face often extend for several years. While it is not possible to accurately
predict or determine the eventual outcomes of matters that have not concluded, an adverse determination in one or more of matter (whether
discussed in this footnote or not) currently pending may have a material adverse effect on the Company’s consolidated results of
operations, financial position or cash flows.
F- 40
Certain
recent developments concerning the Company’s legal proceedings it believes are or were material to its business and other matters
are discussed below:
Ocular
Science, Inc. et. al
In
July 2021, ImprimisRx, LLC, a subsidiary of the Company, filed a lawsuit against Ocular Science, Inc. and OSRX, Inc. (together, “OSRX”)
in the U.S. District Court for the Southern District of California, asserting claims for copyright infringement, trademark infringement,
unfair competition and false advertising (Lanham Act). Since July 2021, the complaint has been amended and OSRX added counterclaims alleging
ImprimisRx, LLC is violating the Lanham Act with false advertising. The Court granted cross motions for summary judgement on each party’s
Lanham Act claims thus leaving only ImprimisRx, LLC’s copyright infringement, trademark infringement and unfair competition claims
for trial. ImprimisRx, LLC is seeking damages from OSRX. The Company expects the trial to take place in August 2024.
Product
and Professional Liability
Product
and professional liability litigation represents an inherent risk to all firms in the pharmaceutical and pharmacy industry. We utilize
traditional third-party insurance policies with regard to our product and professional liability claims. Such insurance coverage at any
given time reflects current market conditions, including cost and availability, when the policy is written.
Indemnities
In
addition to the indemnification provisions contained in the Company’s charter documents, the Company generally enters into separate
indemnification agreements with each of the Company’s directors and officers. These agreements require the Company, among other
things, to indemnify the director or officer against specified expenses and liabilities, such as attorneys’ fees, judgments, fines
and settlements, paid by the individual in connection with any action, suit or proceeding arising out of the individual’s status
or service as the Company’s director or officer, other than liabilities arising from willful misconduct or conduct that is knowingly
fraudulent or deliberately dishonest, and to advance expenses incurred by the individual in connection with any proceeding against the
individual with respect to which the individual may be entitled to indemnification by the Company. Several of the Company’s asset
purchase and license agreements contain customary representations, warranties, covenants and confidentiality provisions, and also contain
mutual indemnification obligations related primarily to performance under the respective agreements. The Company also indemnifies its
lessors in connection with its facility leases for certain claims arising from the use of the facilities. These indemnities do not provide
for any limitation of the maximum potential future payments the Company could be obligated to make. Historically, the Company has not
incurred any payments for these obligations and, therefore, no liabilities have been recorded for these indemnities in the accompanying
consolidated balance sheets.
Sales
and Marketing Agreements
The
Company has entered various sales and marketing agreements with certain organizations, to provide sales and marketing representation
services to ImprimisRx in select geographies in the U.S., in connection with the Company’s ophthalmic compounded formulations.
Under
the terms of the sales and marketing agreements, the Company is required to make commission payments generally equal to 10 % to 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. The Company incurred $ 196,000 and $ 4,274,000 under these agreements for
commission expenses during the years ended December 31, 2023 and 2022, respectively, which are included in selling, general and administrative
expenses.
F- 41
Other
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.
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. At December 31, 2023 and 2022, $ 106,000 and $ 228,000 were accrued in accounts payable and accrued expenses related to
these agreements. During the years ended December 31, 2023 and 2022, $ 811,000 and $ 910,000 , respectively, were incurred under these agreements
as royalty expenses, which are included in selling, general and administrative expenses.
Klarity
License Agreement – Related Party
In
April 2017, the Company entered into a license agreement (the “Klarity License Agreement”) with Richard L. Lindstrom, M.D.,
a former 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% to 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 $ 50,000 upon execution of the Klarity License Agreement, (ii) a second
payment of $ 50,000 following the first $ 50,000 in net sales of the Klarity Product; and (iii) a final payment of $ 50,000 following the
first $ 100,000 in net sales of the Klarity Product. 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. Dr. Lindstrom was paid $ 292,000 and $ 274,000 in cash during
the years ended December 31, 2023 and 2022, respectively, and was due an additional $ 67,000 and $ 71,000 at December 31, 2023 and 2022,
respectively. The Company incurred $ 287,000 and $ 315,000 for royalty expenses related to the Klarity License Agreement during the years
ended December 31, 2023 and 2022, respectively, which are included in selling, general and administrative expenses.
Injectable
Asset Purchase Agreement – Related Party
In
December 2019, the Company entered into an asset purchase agreement (the “Lindstrom APA”) with Dr. Lindstrom, a former 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 $ 35,000 and $ 32,000 in cash during the years ended December 31, 2023 and 2022, respectively, and was due $ 6,000 and $ 9,000 at
December 31, 2023 and 2022, respectively. The Company incurred $ 32,000 and $ 33,000 for royalty expenses related to the Lindstrom APA
during the years ended December 31, 2023 and 2022, respectively, which are included in selling, general and administrative expenses.
F- 42
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 former 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
years ended December 31, 2023 and 2022, and was due $ 0 at December 31, 2023 and 2022. The Company incurred $ 0 for royalty expenses related
to the Presbyopia APA during the years ended December 31, 2023 and 2022.
Eyepoint
Commercial Alliance Agreement - Terminated
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 U.S. Pursuant to the
Dexycu Agreement , Eyepoint paid 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 agreed to use commercially reasonable efforts to promote and market DEXYCU in the U.S.
Pursuant
to a mutual termination agreement entered into on October 7, 2022 the Dexycu Agreement terminated
on January 1, 2023. During the years ended December 31, 2023 and 2022, the Company recorded $ 0 and $ 3,866,000 , respectively, in commission
revenues related to the Dexycu Agreement.
NOTE
19. SEGMENTS AND CONCENTRATIONS
The
Company operates its business on the basis of a single reportable segment, which is the business of discovery, development, and commercialization
of innovative ophthalmic therapies. The Company’s chief operating decision-maker is the Chief Executive Officer, who evaluates
the Company as a single operating segment.
Concentrations
The
Company has three and two products that each comprised more than 10% of total revenues during the years ended December 31, 2023 and 2022,
respectively. These products collectively accounted for 38 % and 34 % of revenues, respectively.
As
of December 31, 2023 and 2022, accounts receivable from a single customer accounted for 80 % and 0 % of total accounts receivable, respectively.
For the years ended December 31, 2023 and 2022, revenues from a single customer accounted for 29 % and 0 % of total revenues, respectively.
The
Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 64 % of active
pharmaceutical ingredient purchases during the year ended December 31, 2023, and 61 % during the year ended December 31, 2022.
NOTE
20. SUBSEQUENT EVENTS
In
February 2024, 45,000 RSUs granted in February 2021 to Andrew R. Boll, the Company’s Chief Financial Officer, vested, and 26,520
shares the Company’s common stock were issued to Mr. Boll, net of 18,480 shares of common stock withheld for payroll tax withholdings
totaling $ 197,000 .
In
February 2024, 150,000 RSUs granted in February 2021 to Mark L. Baum, the Company’s Chief Executive Officer, vested, and 90,164
shares the Company’s common stock were issued to Mr. Baum, net of 59,836 shares of common stock withheld for payroll tax withholdings
totaling $ 638,000 .
In
February 2024, 30,000 RSUs granted in February 2021 to John Saharek, the Company’s Chief Commercial Officer, vested, and 17,384
shares the Company’s common stock were issued to Mr. Saharek, net of 12,616 shares of common stock withheld for payroll tax withholdings
totaling $ 135,000 .
In
February 2024, 50,000 RSUs granted in February 2021 to employees, vested, and 32,452 shares the Company’s common stock were issued,
net of 17,548 shares of common stock withheld for payroll tax withholdings totaling $ 187,000 .
In
February and March 2024, the Company issued 27,862 shares of common stock and received proceeds of $ 220,000 upon the exercise of options
to purchase 27,862 shares of common stock with exercise prices between $ 6.75 to $ 8.75 per share.
F- 43