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, 2022, 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, 2022, 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, 2022.
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, 2022, that has materially affected, or is reasonably likely to materially affect our internal control over financial
reporting.
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.
52
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 2023
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 2023 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 2023 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 2023 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 2023 Annual Meeting
of Stockholders.
53
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 by the Certificate of Amendment to Amended and Restated Certificate of Incorporation effective February 28, 2012, as further amended by the Certificate of Amendment to Amended and Restated Certificate of Incorporation effective February 7, 2013, and as further amended by the Certificate of Amendment to Amended and Restated Certificate of Incorporation effective September 10, 2014
3.2
Amended and Restated Bylaws of Imprimis Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 3.2 to the Annual Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on March 28, 2014)
3.3
Certificate of Designation of Series A Convertible Preferred Stock of Imprimis Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on December 20, 2011)
3.4
Amended and Restated Certificate of Incorporation, filed July 2, 2018 (incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on July 2, 2018)
3.5
Amendment to the Restated Certificate of Incorporation for the name change, filed as of December 27, 2018 (incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on December 31, 2018)
3.6
Certificate of Designation of Series B Cumulative Preferred Stock of Harrow Health, Inc. (incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of Harrow Health, Inc. filed with the Securities and Exchange Commission on May 5, 2021)
4.1*
Description of the Company’s Securities
4.2
Indenture dated April 20, 2021 between Harrow Health, 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 Health, Inc. filed with the Securities and Exchange Commission on April 20, 2021).
4.3
First Supplemental Indenture dated April 20, 2021 between Harrow Health, 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 Health, 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 Health, Inc. filed with the Securities and Exchange Commission on April 20, 2021).
4.5
Second Supplemental Indenture dated December 20, 2022 between Harrow Health, 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 Health, 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 Health, 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)
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)
54
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#
Stand-alone Restricted Stock Unit Agreement, dated July 18, 2012, granted by Imprimis Pharmaceuticals, Inc. to Mark L. Baum (incorporated herein by reference to Exhibit 10.40 to the Company’s Registration Statement on Form S-1 (File No. 333-182846) filed on July 25, 2012)
10.8#
Stand-alone Restricted Stock Unit Agreement, dated July 18, 2012, granted by Imprimis Pharmaceuticals, Inc. to Robert J. Kammer (incorporated herein by reference to Exhibit 10.41 to the Company’s Registration Statement on Form S-1 (File No. 333-182846) filed on July 25, 2012)
10.9
Form of Underwriter’s Warrant (incorporated herein by reference to Exhibit 10.41 to the Company’s Registration Statement on Form S-1 (File No. 333-182846) filed on October 26, 2012)
10.10#
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)
10.11#
Performance
Stock Units Agreement, dated May 2, 2013, by and between Imprimis Pharmaceuticals, Inc. and Mark L. Baum (incorporated herein by
reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on August 14, 2013)
10.12#
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)
10.13#
Performance Stock Units Award Agreement, effective as of February 1, 2015, by and between Imprimis Pharmaceuticals, Inc. and Andrew R. Boll (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 2, 2015)
10.14#
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)
10.15#
Warrant to Purchase Stock, dated May 11, 2015, issued by Imprimis 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 12, 2015)
10.16#
Warrant Amendment to Purchase Stock, dated December 27, 2016, issued by Imprimis Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.3 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on December 29, 2016)
10.17#
Form of Securities Purchase Agreement, dated March 21, 2017, between the Registrant and the Investors (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 March 22, 2017)
10.18
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)
10.19
Strategic Sales & Marketing Agreement dated April 13, 2017 between Imprimis Pharmaceuticals, Inc. and Cameron Ehlen Group, 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 April 17, 2017)
10.20
Strategic Sales & Marketing Agreement dated April 28, 2017 between Imprimis Pharmaceuticals, Inc. and SightLife Surgical, 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 2, 2017)
10.21#
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)
10.22#
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)
10.23#
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)
55
10.24
Asset Purchase and License Agreement (pentoxifylline) dated May 9, 2017 between Imprimis Pharmaceuticals, Inc. and Eton 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 June 20, 2017)
10.25
Asset Purchase and License Agreement (corticotropin) dated May 9, 2017 between Imprimis Pharmaceuticals, Inc. and Eton 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 June 20, 2017)
10.26
Management Services Agreement dated May 1, 2017 between Imprimis Pharmaceuticals, Inc. and Eton Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.4 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on June 20, 2017)
10.27#
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)
10.28#
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)
10.29#
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)
10.30
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)
10.31
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)
10.32
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)
10.33
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)
10.34#
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)
10.35#
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)
10.36#
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)
10.37
Asset Purchase Agreement dated December 11, 2018 between Harrow Health, 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 Health, Inc. filed with the Securities and Exchange Commission on February 5, 2019)
10.38
Asset Purchase Agreement dated February 1, 2019 between Harrow Health, Inc. and Mayfield Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of Harrow Health, Inc. filed with the Securities and Exchange Commission on May 9, 2019)
10.39
Asset Purchase Agreement dated February 1, 2019 between Harrow Health, Inc. and Elle Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of Harrow Health, Inc. filed with the Securities and Exchange Commission on May 9, 2019)
10.40
Joinder and Amendment to Loan and Security Agreement, dated May 24, 2019, by and between Harrow Health, Inc., each of its wholly-owned subsidiaries and SWK Funding LLC. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Harrow Health, Inc. filed with the Securities and Exchange Commission on May 29, 2019)
56
10.41#
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 Health, Inc. filed with the Securities and Exchange Commission on August 14, 2019)
10.42#
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 Health, Inc. filed with the Securities and Exchange Commission on August 14, 2019)
10.43#
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 Health, Inc. filed with the Securities and Exchange Commission on August 14, 2019)
10.44
License Agreement, dated July 28, 2019, among Mayfield Pharmaceuticals, Inc., TGV-Health, LLC and TGV-Gyneconix, LLC (incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of Harrow Health, Inc. filed with the Securities and Exchange Commission on November 13, 2019).
10.45
License Agreement, dated July 29, 2019, among Stowe Pharmaceuticals, Inc., TGV-Health, LLC and TGV-Ophthalnix, LLC (incorporated herein by reference to Exhibit 10.4 to the Quarterly Report on Form 10-Q of Harrow Health, Inc. filed with the Securities and Exchange Commission on November 13, 2019).
10.46#
Consulting Agreement dated February 13, 2020 between Stowe Pharmaceuticals, Inc. and Mark L. Baum (incorporated herein by reference to Exhibit 10.65#* to the Annual Report on Form 10-K of Harrow Health, Inc. filed with the Securities and Exchange Commission on March 13, 2020).
10.47#
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 Health, Inc. filed with the Securities and Exchange Commission on March 13, 2020).
10.48#
Consulting Agreement dated February 13, 2020 between Stowe Pharmaceuticals, Inc. and John P. Saharek (incorporated herein by reference to Exhibit 10.65#* to the Annual Report on Form 10-K of Harrow Health, Inc. filed with the Securities and Exchange Commission on March 13, 2020).
10.49
Business Loan Agreement with Renasant Bank pursuant to the Paycheck Protection Program, dated April 27, 2020 (incorporated herein by reference to Exhibit 10.1* to the Quarterly Report on Form 10-Q of Harrow Health, Inc. filed with the Securities and Exchange Commission on August 10, 2020).
10.50
Second Amendment, dated as of April 1, 2020, to the Loan and Security Agreement by and among Harrow Health, Inc., several of its wholly-owned subsidiaries and the Lenders named therein (incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of Harrow Health, Inc. filed with the Securities and Exchange Commission on August 10, 2020).
10.51
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 Health, Inc. filed with the Securities and Exchange Commission on November 9, 2020).
10.52
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 Health, Inc. filed with the Securities and Exchange Commission on March 10, 2022)
10.53
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 Health, Inc. filed with the Securities and Exchange Commission on November 14, 2022)
10.54
License and Supply Agreement dated July 25, 2021 between Harrow Health, Inc. and Sintetica, S.A. (incorporated herein by reference to Exhibit 10.2 to the Current Report on Form 10-Q of Harrow Health, Inc. filed with the Securities and Exchange Commission on August 10, 2021)
10.55#
Harrow Health, 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)
10.56#
First Amendment to the Harrow Health, Inc. 2017 Incentive Stock and Awards Plan (incorporated herein by reference to Appendix A to Harrow Health, Inc.’s Definitive Proxy Statement filed with the Securities and Exchange Commission on April 23, 2021)
10.57
Loan and Security Agreement dated September 1, 2021 among Harrow Health, Inc. and Melt Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Harrow Health, Inc. filed with the Securities and Exchange Commission on September 2, 2021)
10.58
First Amendment to Loan and Security Agreement dated April 8, 2022 between Harrow Health, Inc. and Melt Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q of Harrow Health, Inc. filed with the Securities and Exchange Commission on November 14, 2022)
10.59
Second Amendment to Loan and Security Agreement dated September 21, 2022 between Harrow Health, Inc. and Melt Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of Harrow Health, Inc. filed with the Securities and Exchange Commission on November 14, 2022)
10.60
Basic Sale and Purchase Agreement dated August 18, 2021 between Harrow Health, Inc. and Wakamoto Pharmaceutical Co., Ltd. (incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of Harrow Health, Inc. filed with the Securities and Exchange Commission on November 9, 2021)
10.61
License Agreement dated August 18, 2021 between Harrow Health, Inc. and Wakamoto Pharmaceutical Co., Ltd. (incorporated herein by reference to Exhibit 10.4 to the Quarterly Report on Form 10-Q of Harrow Health, Inc. filed with the Securities and Exchange Commission on November 9, 2021)
10.62
Asset Purchase Agreement dated December 17, 2021 between Harrow Health, 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 Health, Inc. filed with the Securities and Exchange Commission on March 10, 2022)
10.63
Asset Purchase Agreement dated December 13, 2022 between Harrow Health, Inc. and Novartis Technology, LLC and Novartis Innovative Therapies AG (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 10-K of Harrow Health, Inc. filed with the Securities and Exchange Commission on December 14, 2022).
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.
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.
57
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
HEALTH, INC.
By:
/s/
Mark L. Baum
Mark
L. Baum
Chief
Executive Officer (Principal Executive Officer)
Date:
March
23, 2023
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
23, 2023
Mark
L. Baum
(Principal
Executive Officer)
/s/
Andrew R. Boll
Chief
Financial Officer and Corporate Secretary
March
23, 2023
Andrew
R. Boll
(Principal
Accounting and Financial Officer)
/s/ R.
Lawrence Van Horn
Director
March
23, 2023
R.
Lawrence Van Horn
/s/
Teresa F. Sparks
Director
March
23, 2023
Teresa
F. Sparks
/s/
Richard L. Lindstrom
Director
March
23, 2023
Richard
L. Lindstrom
/s/
Perry J. Sternberg
Director
March
23, 2023
Perry
J. Sternberg
/s/
Martin Makary
Director
March
23, 2023
Martin
Makary
58
FINANCIAL
STATEMENTS
Harrow
Health, 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, 2022 and 2021
F-3
Consolidated Statements of Operations for the years ended December 31, 2022 and 2021
F-4
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2022 and 2021
F-5
Consolidated Statements of Cash Flows for the years ended December 31, 2022 and 2021
F-6
Notes to the Consolidated Financial Statements
F-7
F- 1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Stockholders and Board of Directors
Harrow Health, Inc.
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance
sheets of Harrow Health, Inc. and subsidiaries (the “Company”) as of December 31, 2022 and 2021, the related consolidated
statements of operations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2022,
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,
2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, 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.
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
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 23, 2023
F- 2
HARROW HEALTH, INC.
CONSOLIDATED BALANCE SHEETS
2022
2021
December 31,
2022
2021
ASSETS
Current assets
Cash and cash equivalents
$ 96,270,000
$ 42,167,000
Investment in Eton Pharmaceuticals
5,589,000
8,503,000
Accounts receivable, net
6,249,000
4,470,000
Inventories
6,541,000
4,217,000
Prepaid expenses and other current assets
3,611,000
1,305,000
Total current assets
118,260,000
60,662,000
Property, plant and equipment, net
3,486,000
3,141,000
Capitalized software costs, net
2,112,000
1,313,000
Deferred financing costs
1,950,000
-
Operating lease right-of-use assets, net
7,513,000
5,935,000
Intangible assets, net
23,725,000
15,813,000
Investment in Melt Pharmaceuticals
-
11,133,000
Goodwill
332,000
332,000
TOTAL ASSETS
$ 157,378,000
$ 98,329,000
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable and accrued expenses
$ 13,771,000
$ 6,337,000
Accrued payroll and related liabilities
4,025,000
3,089,000
Deferred revenue and customer deposits
113,000
16,000
Current portion of operating lease obligations
723,000
272,000
Current portion of finance lease obligations
-
8,000
Total current liabilities
18,632,000
9,722,000
Operating lease obligations, net of current portion
7,332,000
6,012,000
Finance lease obligations, net of current portion
-
10,000
Notes payable, net of unamortized debt discount
104,174,000
71,654,000
TOTAL LIABILITIES
130,138,000
87,398,000
Commitments and contingencies
-
-
STOCKHOLDERS’ EQUITY
Common stock, $ 0.001 par value, 50,000,000 shares authorized, 29,901,530 and 26,902,763
shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively
30,000
27,000
Additional paid-in capital
137,058,000
106,666,000
Accumulated deficit
( 109,493,000 )
( 95,407,000 )
TOTAL HARROW HEALTH STOCKHOLDERS’ EQUITY
27,595,000
11,286,000
Noncontrolling interests
( 355,000 )
( 355,000 )
TOTAL STOCKHOLDERS’ EQUITY
27,240,000
10,931,000
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 157,378,000
$ 98,329,000
The accompanying notes are an integral part of these consolidated financial statements
F- 3
HARROW HEALTH, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
For the
For the
Year Ended
Year Ended
December 31,
December 31,
2022
2021
Revenues:
Product sales, net
$ 83,524,000
$ 69,104,000
Other revenues
5,071,000
3,372,000
Total revenues
88,595,000
72,476,000
Cost of sales
( 25,383,000 )
( 18,214,000 )
Gross profit
63,212,000
54,262,000
Operating expenses:
Selling, general and administrative
58,243,000
41,315,000
Research and development
3,050,000
11,084,000
Impairment of long-lived assets
-
249,000
Total operating expenses
61,293,000
52,648,000
Income from operations
1,919,000
1,614,000
Other income (expense):
Interest expense, net
( 7,244,000 )
( 5,436,000 )
Equity in losses of unconsolidated entities
( 11,133,000 )
( 5,334,000 )
Investment loss from Eton Pharmaceuticals
( 2,914,000 )
( 10,126,000 )
Loss on early extinguishment of debt
-
( 756,000 )
Gain on forgiveness of PPP loan
-
1,967,000
Gain on sale of non-ophthalmology assets
5,259,000
-
Other income, net
102,000
197,000
Total other expense, net
( 15,930,000 )
( 19,488,000 )
Loss before income tax provision
( 14,011,000 )
( 17,874,000 )
Income tax provision
( 75,000 )
( 133,000 )
Net loss
( 14,086,000 )
( 18,007,000 )
Preferred dividends and accretion of preferred stock issuance costs
-
( 472,000 )
Net loss attributable to common stockholders
$ ( 14,086,000 )
$ ( 18,479,000 )
Basic and diluted net loss per share of common stock
$ ( 0.51 )
$ ( 0.69 )
Weighted average number of shares of common stock outstanding, basic and
diluted
27,460,968
26,757,451
The accompanying notes are
an integral part of these consolidated financial statements
F- 4
HARROW HEALTH, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
For the years ended December 31, 2022 and 2021
Preferred Stock
Common Stock
Additional
Harrow Health, Inc.
Total
Noncontrolling
Total
Par
Par
Paid-in
Accumulated
Stockholders’
Interests
Stockholders’
Shares
Value
Shares
Value
Capital
Deficit
Equity
Equity
Equity
Balance at December 31, 2020
-
$ -
25,749,875
$ 26,000
$ 104,557,000
$ ( 77,400,000 )
$ 27,183,000
$ ( 355,000 )
$ 26,828,000
Issuance of common stock in connection with:
Exercise of employee stock-based options
-
-
25,480
-
65,000
-
65,000
-
65,000
Exercise of warrants
-
-
311,369
-
-
-
-
-
-
Vesting of RSUs
-
-
1,207,500
1,000
( 1,000 )
-
-
-
-
Shares withheld related to net share settlement of equity awards
-
-
( 391,461 )
-
( 3,228,000 )
-
( 3,228,000 )
-
( 3,228,000 )
Issuance of preferred shares, net of discounts and issuance costs
440,000
-
-
-
10,655,000
-
10,655,000
-
10,655,000
Redemption of preferred shares
( 440,000 )
-
-
-
( 11,000,000 )
-
( 11,000,000 )
-
( 11,000,000 )
Payment of preferred dividends
-
-
-
-
( 127,000 )
-
( 127,000 )
-
( 127,000 )
Stock-based compensation expense
-
-
-
-
5,745,000
-
5,745,000
-
5,745,000
Net loss
-
-
-
-
-
( 18,007,000 )
( 18,007,000 )
-
( 18,007,000 )
Balance at December 31, 2021
-
$ -
26,902,763
$ 27,000
$ 106,666,000
$ ( 95,407,000 )
$ 11,286,000
$ ( 355,000 )
$ 10,931,000
Beginning balance
-
$ -
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
Ending balance
-
$ -
$ 29,901,530
$ 30,000
$ 137,058,000
$ ( 109,493,000 )
$ 27,595,000
$ ( 355,000 )
$ 27,240,000
The accompanying notes are an integral part of these consolidated financial statements
F- 5
HARROW HEALTH, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
2022
2021
For the Years Ended
December 31,
2022
2021
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$ ( 14,086,000 )
$ ( 18,007,000 )
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation and amortization of property, plant and equipment
1,477,000
1,717,000
Amortization of intangible assets
1,578,000
161,000
Amortization of operating lease right-of-use assets
610,000
518,000
Provision for bad debt expense
81,000
35,000
Amortization of debt issuance costs and discount
782,000
677,000
Gain on forgiveness of PPP loan
-
( 1,967,000 )
Investment loss from Eton Pharmaceuticals
2,914,000
10,126,000
Equity in losses of unconsolidated entities
11,133,000
5,334,000
Loss on disposal of equipment
69,000
41,000
Loss on early extinguishment of loan
-
706,000
Impairment of long-lived assets
-
249,000
Stock-based compensation
7,974,000
5,745,000
Gain on sale of non-ophthalmology assets
( 5,259,000 )
-
Changes in assets and liabilities:
Accounts receivable
( 1,860,000 )
( 1,831,000 )
Inventories
( 2,324,000 )
( 255,000 )
Prepaid expenses and other current assets
( 4,256,000 )
( 621,000 )
Accounts payable and accrued expenses
1,839,000
1,730,000
Accrued payroll and related liabilities
936,000
774,000
Deferred revenue and customer deposits
97,000
( 50,000 )
NET CASH PROVIDED BY OPERATING ACTIVITIES
1,705,000
5,082,000
CASH FLOWS FROM INVESTING ACTIVITIES
Net proceeds from sale of investments
-
9,826,000
Issuance of note receivable, Melt Pharmaceuticals
-
( 12,592,000 )
Proceeds from sale of non-ophthalmology assets
6,000,000
-
Proceeds from sale of property, plant and equipment
30,000
-
Investment in patent and trademark assets
( 176,000 )
( 84,000 )
Purchase of licenses, product NDAs and patents
( 5,000,000 )
( 14,050,000 )
Purchases of property, plant and equipment
( 2,597,000 )
( 1,786,000 )
NET CASH USED IN INVESTING ACTIVITIES
( 1,743,000 )
( 18,686,000 )
CASH FLOWS FROM FINANCING ACTIVITIES
Payments on finance lease obligations
( 18,000 )
( 7,000 )
Proceeds from 8.625% notes payable, net of costs
-
71,073,000
Proceeds from 11.875% notes payable, net of costs
31,738,000
-
Principal and exit fee payments on SWK loan
-
( 15,961,000 )
Proceeds from common stock, net of offering costs
22,655,000
-
Payment of taxes upon vesting of RSUs
( 876,000 )
( 3,228,000 )
Proceeds from exercise of stock options
642,000
65,000
Sale of preferred stock, net of discount and issuance costs
-
10,655,000
Repayment of preferred stock
-
( 11,000,000 )
Payment of preferred stock dividends
-
( 127,000 )
NET CASH PROVIDED BY FINANCING ACTIVITIES
54,141,000
51,470,000
NET CHANGE IN CASH AND CASH EQUIVALENTS
54,103,000
37,866,000
CASH AND CASH EQUIVALENTS, beginning of year
42,167,000
4,301,000
CASH AND CASH EQUIVALENTS, end of year
$ 96,270,000
$ 42,167,000
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid for income taxes
$ 75,000
$ 11,000
Cash paid for interest
$ 6,480,000
$ 4,823,000
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING
Purchase of property, plant and equipment included in
accounts payable and accrued expenses
$ 123,000
$ 123,000
Purchase of intangible asset included in accounts payable and accrued expenses
$ 5,000,000
$ -
Right-of-use assets obtained in exchange for new operating lease obligations
$ 2,188,000
$ -
Net reduction in right-of-use assets and lease obligations due to modification
$ -
$ 346,000
Melt accounts receivable transferred to note receivable
$ -
$ 908,000
The accompanying notes are
an integral part of these consolidated financial statements
F- 6
HARROW
HEALTH, INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
For
the Years Ended December 31, 2022 and 2021
NOTE
1. ORGANIZATION
Harrow
Health, Inc. (together with its subsidiaries, partially owned companies and royalty arrangements unless the context indicates or otherwise
requires, the “Company” or “Harrow”) is an eyecare pharmaceutical company exclusively focused on the discovery,
development, and commercialization of innovative ophthalmic therapies that are accessible and affordable.
The
Company owns non-controlling equity positions 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.
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’s operations. The Company
consolidates (i) entities in which it holds and/or controls, directly or indirectly, more than 50% of the voting rights , and (ii) entities
that the Company deems to be a VIE. 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 doubtful accounts, 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 taxes, goodwill and intangible assets, recoverability of long-lived assets and goodwill, 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.
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, 2022 and 2021, relate to consolidated subsidiaries that
the Company owns a controlling stake in, but not 100 % of the equity interests, and that no longer have active operations, assets and
related financial activity.
F- 7
Segments
As
a result of shifts in the Company’s strategic plans to further focus on growing the Company’s ImprimisRx business and suspension
of activities related to starting up development-stage pharmaceutical companies, along with changes to the Company’s organizational
and internal reporting structure, beginning in January 2022, management no longer evaluates the Company’s business in two segments
and instead focuses on the performance of the business as a single operating business.
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.
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 loans 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, which will be recorded as a debt issuance cost and net of the related BR Loan in January 2023 (see Notes 13 and 20).
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.
F- 8
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, 2022 and 2021, there were no 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, 2022 and 2021, and has not recognized interest and/or penalties in the consolidated
statements of operations for the years ended December 31, 2022 and 2021. The Company is subject to taxation in the United States, California,
Florida, Georgia, Illinois, New Jersey, New York, Tennessee, and Wisconsin. 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.
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. In various accounts the Company
has cash deposits in excess of FDIC limits.
Investment in Eton Pharmaceuticals, Inc. – Related Party
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 the Accounting Standards Update
(“ASU”) 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets
and Financial Liabilities , the Company recorded an unrealized investment loss from its Eton common stock position of $( 2,914,000 ) and
$( 8,720,000 ), during the years ended December 31, 2022 and 2021, respectively, related to the change in fair market value of its investment
in Eton during the measurement period.
During
the year ended December 31, 2021, the Company sold 1,518,000 shares of its Eton common stock through an underwritten
public offering at a public offering price of $ 7.00 per share (the “Eton Stock Sale”). The gross proceeds to the Company
from the Eton Stock Sale were $ 10,626,000 , before deducting underwriting discounts and commissions and other offering expenses payable
by the Company of $ 799,000 . During the year ended December 31, 2021, the Company recorded a realized loss of $ 1,406,000 related
to the Eton Stock Sale. Following the Eton Stock Sale and as of December 31, 2022, the Company owns 1,982,000 shares
of Eton common stock, which represents less than 10 % of the equity interests of Eton. At December 31, 2022, the fair market
value of Eton’s common stock was $ 2.82 per share. As of December 31, 2022 and 2021, the fair market value of the Company’s
investment in Eton was $ 5,589,000 and $ 8,503,000 , respectively.
Accounts
Receivable
Accounts
receivable are stated net of allowances for doubtful accounts 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. Charges to bad debt are based on both historical write-offs and specifically
identified receivables. Accounts receivable are presented net of allowances for doubtful accounts and contractual adjustments in the
amount of $ 779,000 and $ 40,000 as of December 31, 2022 and 2021, respectively.
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.
F- 9
Investment
in Melt Pharmaceuticals, Inc. – Related Party
The
Company owns 3,500,000 shares of common stock of Melt (representing approximately 46 % of the equity interests as of December 31, 2022).
The Company analyzes its investment in Melt and related agreements on a regular basis to evaluate its position of variable interests
in Melt. The Company has determined that it does not have the ability to control Melt, however it has the ability to exercise significant
influence over the operating and financial decisions of Melt and uses the equity method of accounting for this investment. Under this
method, the Company recognizes earnings and losses in Melt in its consolidated financial statements and adjusts the carrying amount of
its investment in Melt accordingly. Any intra-entity profits and losses are eliminated. During the year ended December 31, 2021, the
Company reduced the carrying value of its common stock investment in Melt to $ 0 as a result of the Company recording its share of equity
losses in Melt since its deconsolidation in 2019. As of December 31, 2022 and 2021, 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 treats interest paid in kind on the Melt Loan Agreement as an in-substance
capital contribution and reduces its investment in Melt accordingly, rather than recording interest income. The Company has no other
requirements to advance funds to Melt.
The
following table summarizes the Company’s investments in Melt as of December 31, 2022:
SCHEDULE OF INVESTMENT
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 )
$ -
The
following table summarizes the Company’s investments in Melt as of December 31, 2021:
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
( 2,367,000 )
576,000
( 576,000 )
11,133,000
$ 19,310,000
$ ( 8,177,000 )
$ 576,000
$ ( 576,000 )
$ 11,133,000
At
December 31, 2022 and 2021, the Company recorded $ 139,000 and $ 48,000 , 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.
The
following table summarizes the Company’s investment in Surface as of December 31, 2022 and 2021:
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.
F- 10
Impairment
of Equity Method Investment and Note Receivable
On
a quarterly basis, management assesses whether there are any indicators that the carrying value of the Company’s equity method
investments and note receivable may be other than temporarily impaired. Indicators include financial condition, operating performance,
and near-term prospects of the investee. To the extent indicators suggest that a loss in value may have occurred, the Company will evaluate
both quantitative and qualitative factors to determine if the loss in value is other than temporary. If a potential loss in value is
determined to be other than temporary, the Company will recognize an impairment loss based on the estimated fair value of the equity
method investments and note receivable. At December 31, 2022 and December 31, 2021, no indicators of impairment existed.
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 capital 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 10 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.
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, an indication exists
that the reporting unit’s goodwill may be impaired and the Company then performs the second step of the impairment test. If the
fair value of a reporting unit exceeds its carrying amount, no further analysis is required.
Step
2. If further analysis is required, the Company compares the implied fair value of the reporting unit’s goodwill, determined by
allocating the reporting unit’s fair value to all of its assets and its liabilities in a manner similar to a purchase price allocation,
to its carrying amount. If the carrying amount of the reporting unit’s goodwill exceeds its fair value, an impairment loss will
be recognized in an amount equal to the excess.
F- 11
Impairment
of Long-Lived Assets
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. 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 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. 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.
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. Rent 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 of
December 31, 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.
●
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.
●
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, 2022 and 2021, 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, 2022 and 2021, the fair market value of the Company’s investment in Eton was $ 5,589,000 and $ 8,503,000 , respectively.
The
Company carries the 2026 Notes at face value, including the unamortized premium, less unamortized debt issuance costs, and the 2027 Notes
are carried at face value less unamortized debt issuance costs on the consolidated balance sheets and 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
following table presents the estimated fair values and the carrying values:
SCHEDULE
OF ESTIMATED FAIR VALUE
December 31,
2022
2021
Carrying Value
Fair Value
Carrying Value
Fair Value
2026 Notes
$ 72,436,000
$ 71,550,000
$ 71,654,000
$ 78,810,000
2027 Notes
$ 31,738,000
$ 35,112,000
$ -
$ -
F- 12
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 and finance lease
liabilities. The carrying amount of these financial instruments, except for operating and finance 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 and finance 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”)
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 common stockholders for the period by the weighted average
number of common shares outstanding during the period. Diluted income per share is computed by dividing the income attributable to common
stockholders for the period by the weighted average number of common and common equivalent shares, such as stock options and warrants,
outstanding during the period.
Basic
and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period.
Common stock equivalents (using the treasury stock or “if converted” method) from stock options, unvested restricted stock
units (“RSUs”) and warrants were 5,089,420 and 5,646,594 at December 31, 2022 and 2021, respectively, and are excluded in
the calculation of diluted net income per share for the periods presented, because the effect is anti-dilutive for that time period.
Included in the basic and diluted net income (loss) per share calculation were RSUs awarded to directors that had vested, but the issuance
and delivery of the shares are deferred until the director resigns. The number of shares underlying vested RSUs at December 31, 2022
and 2021 was 319,859 and 267,761 , respectively.
The
following table shows the computation of basic net loss per share of common stock for the years ended December 31, 2022 and 2021:
SCHEDULE
OF BASIC AND DILUTED EARNINGS PER COMMON SHARE
2022
2021
For the Years Ended December 31,
2022
2021
Numerator – net loss attributable to Harrow Health, Inc. common stockholders
$ ( 14,086,000 )
$ ( 18,479,000 )
Denominator – weighted average number of shares outstanding, basic
27,460,968
26,757,451
Net loss per share, basic and diluted
$ ( 0.51 )
$ ( 0.69 )
Recent
Accounting Pronouncements Not Yet Adopted
In
June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments . This ASU replaces the incurred
loss impairment methodology in current U.S. 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 fiscal
years beginning after December 15, 2022, as the Company was a smaller reporting company as of November 15, 2019, the determination date.
The Company plans to adopt ASU 2016-13 on January 1, 2023 and has evaluated the effect that this guidance will have on its consolidated
financial statements. Based on the composition of the Company’s accounts receivable and other financial assets, including current
market conditions and historical credit loss activity, the adoption of this standard is not expected to have a material impact on the
Company’s consolidated financial statements.
In
March 2022, the FASB issued ASU 2022-02, Financial Instruments-Credit Losses (Topic 326): Troubled Debt Restructurings and Vintage
Disclosures , which addresses and amends areas identified by the FASB as part of its post-implementation review of the accounting
standard that introduced the current expected credit losses (“CECL”) model. The amendments eliminate the accounting guidance
for troubled debt restructurings by creditors that have adopted the CECL model and enhance the disclosure requirements for loan refinancings
and restructurings made with borrowers experiencing financial difficulty. In addition, the amendments require disclosure of current-period
gross write offs for financing receivables and net investment in leases by year of origination in the vintage disclosures. For entities,
such as the Company, that have not yet adopted the CECL accounting model in ASU 2016-13, the effective date for the amendments in ASU
2022-02 is the same as the effective date in ASU 2016-13 (i.e., fiscal years beginning after December 15, 2022 including interim periods
within those fiscal years). The Company plans to adopt ASU 2022-02 on January 1, 2023. The Company has evaluated the effect of this guidance
and does not expect it to have a material impact on its consolidated financial statements.
F- 13
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: (1) 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, and (3) revenue recognized from intellectual property licenses and asset purchase agreements.
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. ASU 2016-10 was issued in April 2016 and amended ASC 606 for shipping and
handling activities as follows: 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 and other deductions (collectively, sales
deductions) and an estimate for returns and replacements established at the time of sale. The Company utilizes the services of a
third-party professional services firm to estimate rebates and chargebacks associated with sales of its branded products. The transfer
of promised goods is satisfied within a year, and therefore there are no significant financing components. There is no non-cash consideration
related to product sales.
4.
Allocate
the transaction price to the performance obligations in the contract : Given that 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.
F- 14
Revenues
From Transfer of Acquired Product Profit
The
Company entered into an agreement whereby it purchased the exclusive commercial rights to
assets associated with certain ophthalmic products from another pharmaceutical company (the “Seller”). During a temporary,
six month transition period, the Seller continued 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 was calculated by the Seller and confirmed by the Company, typically on a monthly basis, at which
point there is no future performance obligation required by the Company and no consequential continuing involvement on the Company’s
part to recognize the associated revenue. On a quarterly basis, the Seller invoiced the Company for all credits and reimbursements (“Chargebacks”)
made to customers related to the products. The Company used historical actual experience to estimate Chargebacks associated with the
net profit transferred. The estimate is recorded as a reduction in revenues in the Company’s consolidated statements of operations
and 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 deliverable is delivered. Such deliverables may include physical quantities of compounded drug preparations, design of the
compounded drug preparations and structure-activity relationships, the conceptual framework and mechanism of action, and rights to the
patents or patent applications for such compounded drug preparations. The Company defers recognition of non-refundable fees if it has
continuing performance obligations without which the technology, right, product or service conveyed in conjunction with the non-refundable
fee has no utility to the licensee and that are separate and independent of the Company’s performance under the other elements
of the arrangement. In addition, if the Company’s continued involvement is required, through research and development services
that are related to its proprietary know-how and expertise of the delivered technology or can only be performed by the Company, then
such non-refundable fees are deferred and recognized over the period of continuing involvement. Guaranteed minimum annual royalties are
recognized on a straight-line basis over the applicable term.
Revenue
disaggregated by revenue source for the years ended December 31, 2022 and 2021, consists of the following:
SCHEDULE OF DISAGGREGATED REVENUE
2022
2021
For the Years Ended December 31,
2022
2021
Product sales, net
$ 83,524,000
$ 69,104,000
Commissions
3,866,000
3,253,000
Transfer of profit
1,205,000
99,000
License
-
20,000
Total revenues
$ 88,595,000
$ 72,476,000
Deferred
revenue and customer deposits at December 31, 2022 and 2021, were $ 113,000 and $ 16,000 , respectively. All deferred revenue and customer
deposit amounts at December 31, 2021 were recognized as revenue during the year ended December 31, 2022.
NOTE
4. RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES
Acquisition
of ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE
In
December 2022, the Company entered into an Asset Purchase Agreement (the “Fab 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 “Fab 5 Products”) in the
U.S. (the “Fab 5 Acquisition”): ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE. Subsequent to December 31, 2022, the Company
closed the Fab 5 Acquisition in January 2023 (see Note 20).
Under
the terms of the Fab 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. Pursuant to the Fab 5 APA and various ancillary
agreements, immediately following the closing and subject to certain conditions, for a period that the Company expects to last approximately
six months, and prior to the transfer of the Fab 5 Products new drug applications (the “NDAs”) to the Company, Novartis will
continue to sell the Fab 5 Products on the Company’s behalf and transfer the net profit from the sale of the Fab 5 Products to
the Company. Novartis has agreed to supply certain Fab 5 Products to the Company for a period of time after the NDAs are transferred
and to assist with technology transfer of the Fab 5 Products manufacturing to other third-party manufacturers, if needed.
F- 15
Divestiture
of Non-Ophthalmic Assets
In
October 2022, wholly-owned subsidiaries of the Company (“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 six 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 estimated.
In
connection with the RPC Agreement, Imprimis entered into a separate transition services agreement with the Buyer related to providing
on going services associated with the RPC Assets, such as procuring and dispensing prescription orders, providing accounting and billing
services and collecting accounts receivable. The Company expects Imprimis to provide transition services to the Buyer for up to six to
nine months following the effective date of the RPC Agreement. 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, 2022 reflected $ 579,000
of cash collected on behalf of the Buyer and a receivable within accounts receivable of $ 128,000 for cash to be collected on behalf of
the Buyer for sales of RPC Assets sold through December 31, 2022.
The
amount due from the Buyer for reimbursement of services performed under the transition services agreement was $ 254,000 as of December 31, 2022. Such amount was netted
against the amounts collected on behalf of the Buyer and was unpaid within accrued expenses on the consolidated balance sheet as of
December 31, 2022. The combined total of $ 453,000 was recorded within accrued expenses on the consolidated balance sheet as of December
31, 2022 and represents a payable to the Buyer. The Company recorded income from the transition services agreement of $ 102,000 which
is presented in other income on the consolidated statement of operations for the year ended December 31, 2022.
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
Acquisition
of IOPIDINE, MAXITROL and MOXEZA
In
December 2021, the Company entered into an Asset Purchase Agreement (the “NVS Agreement”) with Novartis Technology, LLC and
Novartis Ophthalmics AG (together, “NVS”), pursuant to which the Company purchased from NVS the exclusive commercial rights,
including the NDAs, to assets associated with ophthalmic products Moxeza, Iopidine 1% and 0.5%, and Maxitrol eyedrops suspension (collectively
the “NVS Products”) in the United States of America (“U.S.”) . The Company made a one-time payment of $ 14,050,000
to NVS for the U.S. rights to the NVS Products and their related intellectual property. Pursuant
to the NVS Agreement and various ancillary agreements, immediately following the Closing
Date and subject to certain conditions, for a period of up to six months, and prior to the transfer of the NVS
Products NDAs (the “ NVS NDAs”) to the Company, NVS sold the NVS
Products on the Company’s behalf and transferred the net profit from the sale of the NVS
Products to the Company. NVS has agreed to supply certain NVS Products to the Company
for a period of time after the NVS NDAs are transferred to the Company and to assist with
technology transfer of the NVS Products manufacturing to other third-party manufacturers,
if needed.
F- 16
The
Company accounted for this transaction as an asset acquisition, as the Company only acquired the rights and related intellectual property
for the NVS Products and the cost was allocated to the acquired patents and NDAs based on their relative fair values.
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.
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.
License
and Purchase of MAQ-100
In
August 2021, the Company entered into a License Agreement and a Basic Sale and Purchase Agreement (together, the “Wakamoto Agreements”)
with Wakamoto Pharmaceutical Co., Ltd. (“Wakamoto”), pursuant to which Wakamoto granted the Company the exclusive license
and marketing rights to its ophthalmic drug candidate (“MAQ-100”) in the U.S. and Canada.
Pursuant
to the Wakamoto Agreements, Wakamoto will supply MAQ-100 to the Company, and the
Company will pay Wakamoto a per unit transfer price to supply MAQ-100. In addition, the Company is required to pay Wakamoto various one-time
milestone payments totaling up to $ 2,000,000 upon the achievement of certain regulatory milestones and up to $ 6,200,000 upon
the achievement of certain commercial milestones. Under the terms of the Agreements, the Company will be responsible for regulatory filings
and fees for MAQ-100 in the U.S. and Canada. Through December 31, 2022, no amounts have been paid or accrued under the Wakamoto agreement.
Subject
to certain limitations, the term of the Wakamoto Agreements is for five years from the date of the FDA’s market approval of MAQ-100
and allows for a five-year extension if certain unit sales thresholds are met.
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 Asset Purchase Agreement”). Pursuant
to the terms of the Melt Asset Purchase Agreement, Melt was assigned certain intellectual property and related rights from the Company
to develop, formulate, make, sell, and sub-license certain Company conscious sedation and analgesia related formulations (collectively,
the “Melt Products”). Under the terms of the Melt Asset Purchase Agreement, Melt is required to make mid-single digit royalty
payments to the Company on net sales of the Melt Products while any patent rights remain outstanding, as well as other conditions.
In
February 2019, the Company and Melt entered into a Management Service Agreement between the Company and Melt (the “Melt MSA”),
whereby the Company provides to Melt certain administrative services and support, including bookkeeping, web services and human resources
related activities, and Melt is required to pay the Company a monthly amount of $ 10,000 . During
the year ended December 31, 2022, the Company recorded $ 91,000 due from Melt for reimbursable expenses and amounts payable pursuant to
the Melt MSA, which are included in prepaid expenses and other current assets in the accompanying condensed consolidated balance sheets. As
of December 31, 2022 and December 31, 2021, the Company was due $ 139,000 and $ 48,000 , respectively, from Melt for reimbursable expenses
and amounts due under the Melt MSA. Melt did not make any payments to the Company during the year ended December 31, 2022.
The
Company’s Chief Executive Officer, Mark L. Baum, was previously a member of the Melt board of directors until his resignation
during the year ended December 31, 2021. Following Mr. Baum’s departure, the Company did not have any representation on
Melt’s board of directors until January 2023, when Mr. Baum re-joined the Melt
board of directors. At the time Mr. Baum re-joined, the Melt board of directors consists of five total board members, including Mr.
Baum, who is the only representative of the Company on Melt’s board of directors.
F- 17
The
unaudited condensed results of operations information of Melt is summarized below:
SCHEDULE
OF CONDENSED INCOME STATEMENT
2022
2021
For the Years Ended December 31,
2022
2021
Revenues, net
$ -
$ -
Loss from operations
$ 12,443,000
$ 6,069,000
Net loss
$ ( 14,446,000 )
$ ( 6,655,000 )
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE
OF CONDENSED BALANCE SHEET
2022
2021
December 31,
2022
2021
Current assets
$ 655,000
$ 11,278,000
Non-current assets
107,000
-
Total assets
$ 762,000
$ 11,278,000
Total liabilities
$ 19,056,000
$ 15,732,000
Total preferred stock and stockholders’ deficit
( 18,294,000 )
( 4,454,000 )
Total liabilities and stockholders’ equity
$ 762,000
$ 11,278,000
Melt
Note Receivable
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 bear interest at 12.50 %
per annum, which interest can be paid in-kind at the option of Melt until the maturity date. The Melt Loan Agreement permits Melt to
pay interest only on the principal amount loaned thereunder through the term and all amounts owed 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 June
1, 2023, which can be 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 may elect to prepay all, but not less than all, of the amounts owed prior to the maturity
date at any time without penalty.
Melt
has granted the Company a security interest in substantially all of its personal property, rights and assets, including intellectual
property rights, to secure the payment of all amounts owed under the Melt Loan Agreement. The Melt Loan Agreement contains customary
representations, warranties and covenants, including covenants by Melt limiting additional indebtedness, liens, mergers and acquisitions,
dispositions, investments, distributions, subordinated debt, and transactions with affiliates. The Melt Loan Agreement includes customary
events of default, and upon the occurrence of an event of default (subject to cure periods for certain events of default), all amounts
owed by Melt thereunder may be declared immediately due and payable by the Company, and the interest rate on the loan may be increased
by 3 % per annum.
In
connection with the Melt Loan Agreement, the Company and Melt entered into a Right of First Refusal Agreement providing the Company with
the right, but not the obligation, to match any offer received by Melt associated with the commercial rights to any of Melt’s drug
candidates for a period of five years following the effective date of the Melt Loan Agreement.
The
net funds received by Melt excluded $ 908,000 owed to the Company for reimbursable expenses and amounts due under the Melt MSA prior
to the effective date of the note receivable. As of December 31, 2022 and 2021, aggregate principal and accrued interest payable to the
Company pursuant to the Melt Loan Agreement amounted to $ 15,984,000 and $ 14,076,000 , respectively. In accordance with ASC 328, Investments
– Equity Method and Joint Ventures , the carrying amount of the notes receivable has been reduced by the Company’s allocated
share of Melt’s losses based on its ownership of total debt owed by Melt (see Note 2).
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.
F- 18
As
of December 31, 2022, the Company owned 3,500,000 shares of Surface common stock. Company directors Richard L. Lindstrom, Perry
J. Sternberg and Mark L. Baum, who is also the Company’s Chief Executive Officer, are directors of Surface. Dr. Lindstrom is a
principal of Flying L Partners, an affiliate of an investor who purchased Surface Series A Preferred Stock.
The
unaudited condensed results of operations information of Surface is summarized below:
SUMMARY
OF CONDENSED INCOME STATEMENT
2022
2021
For the Years Ended December 31,
2022
2021
Revenues, net
$ -
$ -
Loss from operations
$ ( 6,719,000 )
$ 10,468,000
Net loss
$ ( 6,579,000 )
$ ( 10,143,000 )
The
unaudited condensed balance sheet information of Surface is summarized below:
SUMMARY
OF CONDENSED BALANCE SHEET
2022
2021
December 31,
2022
2021
Current assets
$ 15,350,000
$ 21,731,000
Non-current assets
652,000
412,000
Total assets
$ 16,002,000
$ 22,143,000
Total liabilities
$ 1,586,000
$ 1,514,000
Total stockholders’ equity
14,416,000
20,629,000
Total liabilities and stockholders’ equity
$ 16,002,000
$ 22,143,000
NOTE
7. INVENTORIES
Inventories
are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, commercial pharmaceutical
products, related laboratory supplies and active pharmaceutical ingredients. The composition of inventories as of December 31, 2022 and
2021 was as follows:
SCHEDULE
OF INVENTORIES
2022
2021
December 31,
2022
2021
Raw materials
$ 3,707,000
$ 2,441,000
Work in progress
38,000
-
Finished goods
2,796,000
1,776,000
Total inventories
$ 6,541,000
$ 4,217,000
NOTE
8. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets consisted of the following:
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
2022
2021
December 31,
2022
2021
Prepaid insurance
$ 858,000
$ 728,000
Prepaid computer software related expenses
1,165,000
248,000
Other prepaid expenses
1,331,000
189,000
Receivable due from Melt
139,000
48,000
Deposits and other current assets
118,000
92,000
Total prepaid expenses and other current assets
$ 3,611,000
$ 1,305,000
F- 19
NOTE
9. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment, net at December 31, 2022 and 2021 consisted of the following:
SCHEDULE
OF PROPERTY,PLANT AND EQUIPMENT
2022
2021
December 31,
2022
2021
Property, plant and equipment, net:
Computer hardware
$ 979,000
$ 772,000
Furniture and equipment
860,000
443,000
Lab and pharmacy equipment
4,259,000
4,056,000
Leasehold improvements
6,449,000
5,703,000
Property, plant and equipment,
gross
12,547,000
10,974,000
Accumulated depreciation and amortization
( 9,061,000 )
( 7,833,000 )
Property,
plant and equipment, net
$ 3,486,000
$ 3,141,000
During
the years ended December 31, 2022 and 2021, the Company disposed of property, plant and equipment with a net book value of $ 99,000 and
$ 41,000 , respectively, and during the year ended December 31, 2021 the Company recorded an impairment charge of $ 150,000 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 $ 1,253,000 and $ 1,580,000 during the years ended December 31, 2022 and 2021,
respectively.
During
the year ended December 31, 2021, the Company purchased lab and pharmacy equipment at a cost of $ 753,000 from Eton.
NOTE
10. CAPITALIZED SOFTWARE COSTS
Capitalized
software costs at December 31, 2022 and 2021 consisted of the following:
SCHEDULE
OF FINITE LIVED INTANGIBLE ASSETS
2022
2021
December 31,
2022
2021
Capitalized software costs
Capitalized internal-use software development costs
$ 1,413,000
$ 942,000
Acquired third-party software license for internal-use
159,000
159,000
Total gross capitalized software for internal-use
1,572,000
1,101,000
Accumulated amortization
( 793,000 )
( 569,000 )
Capitalized internal-use software in process
1,333,000
781,000
Total finite lived intangible
assets net
$ 2,112,000
$ 1,313,000
The
Company recorded amortization expense of $ 224,000 and $ 137,000 during the years ended December 31, 2022 and 2021, respectively.
NOTE
11. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at December 31, 2022 consisted of the following:
SCHEDULE
OF INTANGIBLE ASSETS
Amortization
Net
periods
Accumulated
Carrying
(in years)
Cost
amortization
Sold
value
Patents
7 - 19 years Indefinite
$ 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
F- 20
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).
The
Company’s intangible assets at December 31, 2021 consisted of the following:
Amortization
Net
periods
Accumulated
Carrying
(in years)
Cost
amortization
Impairment
value
Patents
7 - 19 years
$ 966,000
$ ( 75,000 )
$ -
$ 891,000
Licenses
20 years
100,000
( 7,000 )
-
93,000
Trademarks
Indefinite
359,000
-
( 99,000 )
260,000
Acquired NDAs
10 years
13,635,000
-
-
13,635,000
Customer relationships
3 - 15 years
1,519,000
( 586,000 )
-
933,000
Trade name
5 years
5,000
( 5,000 )
-
-
Non-competition clause
3 - 4 years
50,000
( 50,000 )
-
-
State pharmacy licenses
25 years
8,000
( 7,000 )
-
1,000
$ 16,642,000
$ ( 730,000 )
$ ( 99,000 )
$ 15,813,000
During
the year ended December 31, 2021, the Company recorded impairment charges of $ 99,000 related to patent filings and trademarks that were
abandoned and/or were associated with products the Company was no longer actively selling.
See
Note 4 related to intangible assets acquired and divested during the years ended December 31, 2022 and 2021.
Amortization
expense for intangible assets for the years ended December 31, 2022 and 2021 were as follows:
SCHEDULE
OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
2022
2021
For the Years Ended December 31,
2022
2021
Patents
$ 86,000
$ 26,000
Licenses
16,000
2,000
Acquired NDAs
1,363,000
-
Customer relationships
113,000
133,000
Amortization of intangible
assets
$ 1,578,000
$ 161,000
Estimated
future amortization expense for the Company’s intangible assets at December 31, 2022 is as follows:
SCHEDULE
OF ESTIMATED FUTURE AMORTIZATION EXPENSE
Years ending December 31,
2023
2,521,000
2024
2,521,000
2025
2,521,000
2026
2,521,000
2027
2,521,000
Thereafter
10,853,000
Intangible assets
$ 23,458,000
There
were no changes in the carrying value of the Company’s goodwill during the years ended December 31, 2022 and 2021.
F- 21
NOTE
12. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses at December 31, 2022 and 2021 consisted of the following:
SCHEDULE
OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
2022
2021
December 31,
2022
2021
Accounts payable
$ 6,440,000
$ 5,174,000
Accrued insurance premium
575,000
-
Accrued IHEEZO milestone payments (see Note 4)
5,000,000
-
Accrued RPC transition payments (see Note 4)
453,000
-
Accrued litigation settlements
49,000
49,000
Accrued interest (see Note 13)
1,254,000
1,114,000
Total accounts payable and accrued expenses
$ 13,771,000
$ 6,337,000
NOTE
13. DEBT
See
Note 20 related to debt transactions that occurred subsequent to December 31, 2022.
11.875%
Senior Notes Due 2027
In
December 2022, the Company closed an offering of $ 35,000,000 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 $ 31,738,000 after deducting underwriting discounts and commissions and expenses
of $ 3,626,000 .
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 .
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 (i) a failure by the Company to complete the Fab 5 Acquisition), subject to certain exceptions, within 180
calendar days after December 20, 2022, or (ii) the occurrence of a Material Change, as defined in the Second Supplemental Indenture.
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 in April
2026, and in May 2021 issued an additional $ 5,000,000 of such notes pursuant to the full exercise of the underwriters’ option
to purchase additional notes (collectively, the “April Notes”). The April Notes were sold to investors at a par value of
$ 25.00 per April Note and the offering resulted in net proceeds to the Company of approximately $ 51,909,000 after deducting
underwriting discounts and commissions and expenses of $ 3,091,000 . In June 2021, in a further issuance of the April Notes, the Company
sold an additional $ 20,000,000 aggregate principal amount of such notes (the “June Notes,” and together with the April
Notes, the “ 2026 Notes”), at a price of $ 25.75 per June Note, with interest of $ 278,000 on the June Notes being
accrued from April 20, 2021 as of the date of issuance. The June offering resulted in net proceeds to the Company of approximately $ 19,164,000 after
deducting underwriting discounts and commissions and expenses of $ 1,158,000 and a premium on note issuance of $ 322,000 . The June
Notes are treated as a single series with the April Notes under the indenture governing the April Notes, dated as of April 20, 2021,
and have the same terms as the April Notes (other than the initial offering price and issue date). T he
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 2026 Notes.
F- 22
Interest
expense related to the 2026 Notes and 2027 Notes totaled $ 7,378,000 and $ 5,132,000 for the years ended December 31, 2022 and
2021, respectively, and included amortization of debt issuance costs and discount of $ 782,000 , and $ 581,000 for the years ended
December 31, 2022 and 2021, respectively.
B.
Riley Loan and Security Agreement
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.
The
BR Loan is secured by an intellectual property security agreement entered into in connection with the BR Loan, and by all assets of the
Company and its material subsidiaries. The outstanding balance of the BR Loan is due in full on the Maturity Date. The BR Loan provides
for voluntary prepayment subject to a prepayment fee of $ 0 if no Loan had been funded or the prepayment or repayment occurs (other than
as a result of acceleration of the BR Loan) on or prior to the date that is 90 days following the Effective Date and up to 3.00 % of the
amount of the Loan based on other payment dates.
The
BR Loan also provides for mandatory and customary prepayments, along with customary representations and warranties, covenants and events
of default. The covenants set forth in the BR Loan included certain affirmative and negative operational and financial covenants, including,
among other things, restrictions on the Company’s ability to incur certain liens, make fundamental changes to its business or engage
in transactions with affiliates.
No
amounts were outstanding under the BR Loan as of December 31, 2022. In January 2023, $ 59,750,000 of principal amount was funded pursuant
to the BR Loan simultaneously with the consummation of the Fab 5 Acquisition (see Note 20).
SWK
Senior Note – Paid in April 2021
In
July 2017, the Company and several of its wholly owned subsidiaries entered into a term loan and security agreement in the principal
amount of $ 16,000,000 (the
“SWK Loan Agreement” or “SWK Loan”) with SWK Funding LLC and its partners (collectively, “SWK”),
as lender and collateral agent. The SWK Loan Agreement was fully funded at closing with a five-year term; however, such term could be
reduced to four years if certain revenue requirements were not achieved. The SWK Loan was secured by substantially all of the Company’s
assets, including its intellectual property rights. The SWK Loan was subsequently amended in May 2019 and again in April 2020. The SWK
Loan bore an interest rate equal to the three-month London Inter-Bank Offered Rate (subject to a minimum of 2.00 % ),
plus an applicable margin of 10.00 % (the
“Margin Rate”); provided that, if, two days prior to a payment date, the Company provided SWK evidence that the Company
has achieved a leverage ratio as of such date of less than 4.00:1:00, the Margin Rate shall equal 9.00%; and if the Company had achieved
a leverage ratio as of such date of less than 3.00:1:00, the Margin Rate shall equal 7.00% . The
leverage ratio means, as of any date of determination, the ratio of: (a) indebtedness as of such date to (b) EBITDA (as defined in the
SWK Loan), of the Company for the immediately preceding 12 month period, adding-back (i) actual litigation expenses for the immediately
preceding 12 month period, minus (ii) actual litigation expenses for the immediately preceding 3 month period multiplied by 4.
A
summary of the material changes contained in the amendment entered into with SWK in April 2020 was as follows:
●
SWK
agreed to make available to the Company, and the Company drew down on, an additional principal amount of $ 1,000,000 ;
●
The
definition of the first amortization date was changed to August 14, 2020, permitting the Company to pay interest only on the principal
amount loaned for the next payment (payments are due on a quarterly basis) following the SWK Second Amendment; and
●
The
interest payment of $ 358,000 due May 14, 2020 was paid in-kind by increasing the principal amount of the term loans by an amount
equal to the interest accrued as of such date.
Interest
expense related to the SWK Loan Agreement, as amended, amounted to $ 647,000 for the year ended December 31, 2021, and included amortization
of debt issuance costs and discounts of $ 96,000 for the year ended December 31, 2021.
In
April 2021, the Company paid $ 15,540,000 related to all outstanding obligations to SWK under the SWK Loan, including outstanding
principal, accrued interest, accrued exit fee and related expenses and recorded a loss from early extinguishment of $ 756,000 related
to the SWK Loan during the year ended December 31, 2021.
F- 23
Paycheck
Protection Program Loan – Forgiven in March 2021
In
April 2020, the Company entered into an unsecured promissory note and related Business Loan Agreement with Renasant Bank, as lender,
for a loan (the “PPP Loan”) in the principal amount of $ 1,967,000 and received cash proceeds of the same amount, pursuant
to the Paycheck Protection Program (the “PPP”) under the Federal Coronavirus Aid, Relief, and Economic Security Act (the
“CARES Act”), which was enacted March 27, 2020. The PPP is administered by the U.S. Small Business Administration (the “SBA”).
On March 30, 2021, the Company received a notice of forgiveness of the full balance of the PPP Loan, including all accrued interest,
in accordance with the terms and conditions of the CARES Act. Related to the forgiveness, the Company recorded a gain on the forgiveness
of the PPP Loan for the loan balance of $ 1,967,000 in the accompanying consolidated statement of operations for the year ended December
31, 2021.
At
December 31, 2022, future minimum payments under the Company’s debt were as follows (excluding debt transactions that occurred
subsequent to December 31, 2022):
SCHEDULE
OF FUTURE MINIMUM PAYMENTS UNDER NOTES PAYABLES
Amount
2023
$ 10,053,000
2024
10,625,000
2025
10,625,000
2026
81,314,000
2027
39,156,000
Total minimum payments
151,773,000
Less: amount representing interest payments
( 41,773,000 )
Notes payable, gross
110,000,000
Less: unamortized discount, net of premium
( 5,826,000 )
Notes payable, net of unamortized discount
$ 104,174,000
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, with an option to extend the term through March 2028 .
●
An
operating lease for 35,326 square feet of lab, warehouse and office space in Ledgewood, New Jersey that expires in July
2026 , with an option to extend the term for two additional five-year periods. This 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, and amended again in May 2021 to
extend the term of the lease to July 2027 and add 8,900 square feet of space.
●
An
operating lease for 5,500 square feet of office space in Nashville, Tennessee that expires in December 2024 , with
an option to extend the term for two additional five-year periods.
●
An
operating lease for 11,552 square feet of lab and office space in Nashville, Tennessee which commenced in June 2022 and
expires in June 2027 .
At
December 31, 2022 and 2021, the weighted-average discount rate and the weighted-average remaining lease term for the operating leases
held by the Company were 6.6 %
and 6.3 %
and 10.9
and 14.6
years, respectively.
During
the years ended December 31, 2022 and 2021, cash paid for amounts included for the operating lease liabilities was $ 925,000 and
$ 1,000,000 , respectively, and the Company recorded operating lease expense of $ 1,117,000 and $ 912,000 , respectively, included in
selling, general and administrative expenses.
F- 24
Future
lease payments under operating leases as of December 31, 2022 were as follows :
SCHEDULE
OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES
Operating Leases
2023
$ 1,231,000
2024
1,262,000
2025
1,093,000
2026
1,114,000
2027
972,000
Thereafter
5,829,000
Total minimum lease payments
11,501,000
Less: amount representing interest payments
( 3,446,000 )
Total operating lease liabilities
8,055,000
Less: current portion, operating lease liabilities
( 723,000 )
Operating lease liabilities, net of current portion
$ 7,332,000
NOTE
15. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Preferred
Stock
At
December 31, 2022 and 2021, the Company had 5,000,000 shares of preferred stock, $ 0.001 par value, authorized and no shares
of preferred stock issued and outstanding.
Series
B Cumulative Preferred Stock – Redeemed in June 2021
In
May 2021, the Company sold 440,000 shares of the Company’s Series B Cumulative Preferred Stock, par value $ 0.001 per
share and liquidation preference of $ 25.00 per share (the “Series B Preferred Stock”), for net proceeds of approximately
$ 10,655,000 . The Series B Preferred Stock was not convertible into our common stock, had no voting rights , except as required by
Delaware law, and was redeemable by the Company at any time. Holders of Series B Preferred Stock were entitled to cumulative cash dividends
at the rate of 9.50 % of the $ 25.00 liquidation preference per year; provided, however, that for each thirty (30) day period
following May 5, 2021, the dividend rate increased at various rates, except as otherwise limited by applicable law. Dividends were payable
quarterly in arrears, on or about the 15th of January, April, July and October, beginning on or about July 15, 2021.
In
June 2021, the Company redeemed all of the outstanding shares of the Series B Preferred Stock. The redemption price for the 440,000 shares
of Series B Preferred Stock outstanding was equal to $ 25.00 per share, plus accrued and unpaid dividends, which in aggregate totaled
$ 11,127,000 . During the year ended December 31, 2021, the Company recorded preferred stock cash dividends and deemed dividends equal
to $ 472,000 .
Common
Stock
At
each of December 31, 2022 and 2021, the Company had 50,000,000 shares of common stock, $ 0.001 par value, authorized.
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- 25
Issuances
During the Year Ended December 31, 2021
During
the year ended December 31, 2021:
● the
Company issued 311,369 shares of its common stock upon the cashless exercise of
warrants to purchase 406,539 shares of common stock with exercise prices between
$ 1.79 and $ 3.75 per share;
● the
Company issued 25,480 shares of its common stock and received net proceeds of $ 65,000
upon the exercise of options to purchase 25,480 shares of common stock with exercise
prices between $ 1.70 and $ 4.29 per share;
● the
Company issued 715,871 shares of its common stock to Mark L. Baum, its Chief Executive
Officer, upon the vesting of 1,050,000 performance-based restricted stock units.
The Company withheld 334,129 shares of common stock to Mr. Baum valued at $ 2,760,000 for
payroll tax purposes;
● the
Company issued 100,168 shares of common stock to Andrew R. Boll, its Chief Financial
Officer, upon the vesting of 157,500 performance-based restricted stock units.
The Company withheld 57,332 shares of common stock to Mr. Boll valued at $ 468,000 for
payroll tax purposes; and
● 67,297 shares
of the Company’s common stock underlying RSUs issued to directors vested, but the issuance
and delivery of these shares are deferred until the applicable director resigns.
Stock
Option Plan
On
September 17, 2007, the Company’s Board of Directors and stockholders adopted the Company’s 2007 Incentive Stock and Awards
Plan, which was subsequently amended on November 5, 2008, February 26, 2012, July 18, 2012, May 2, 2013 and September 27, 2013 (as amended,
the “2007 Plan”). The 2007 Plan reached its term in September 2017, and we can no longer issue additional awards under this
plan, however, options previously issued under the 2007 Plan will remain outstanding until they are exercised, reach their maturity or
are otherwise cancelled/forfeited. On June 13, 2017, the Company’s Board of Directors and stockholders adopted the Company’s
2017 Incentive Stock and Awards Plan which was subsequently amended on June 3, 2021 (as amended, the “2017 Plan” together
with the 2007 Plan, the “Plans”). As of December 31, 2021, 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 2,057,155 shares available for future issuances under the 2017 Plan at December 31, 2022.
Stock
Options
A
summary of stock option activity under the Plan for the year ended December 31, 2022 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, 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, 2022, based on the closing price of the Company’s common stock of $ 14.76 on that date.
The
intrinsic value of the options exercised in 2022 was $ 2,008,000 .
F- 26
During
the year ended December 31, 2022, the Company granted stock options to certain employees and a consultant. The stock options were granted
with an exercise price equal to the current market price of the Company’s common stock, as reported by the securities exchange
on which the common stock was then listed, at the grant date and have contractual terms of 10 years. Vesting terms for
options granted to employees and consultants during the year ended December 31, 2022 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.
On
July 31, 2015, the Company granted to its Chief Executive Officer, Mark Baum, an option (the “Baum Performance Option”) to
purchase 600,000 shares of the Company’s common stock at an exercise price of $ 7.87 per share under the 2007 Plan
subject to the satisfaction of certain market-based vesting criteria. The market-based vesting criteria are separated into five tranches
and require that the Company achieve and maintain certain average stock price targets ranging from $ 9 per share to $ 15 per
share during the five year period following the grant date. On June 4, 2020, the Company amended the Baum Performance Option, to extend
the vesting and contractual term by 5 years. The Company treated this amendment as a modification to the Baum Performance Option
for accounting purposes. The fair value of the modification was $ 1,876,000 using a Monte Carlo simulation model with a five-year
life, 70 % volatility and a risk-free interest rate of 0.40 % .
With
the exception of the Baum Performance Option, the fair value of each option award is estimated on the date of grant using the Black-Scholes-Merton
option pricing model. Beginning on April 1, 2019, the Company began calculating expected volatility based solely on the historical volatilities
of the common stock of the Company. Prior to April 1, 2019, the expected volatility was based on the historical volatilities of the common
stock of the Company and comparable publicly traded companies. The Company previously utilized this methodology based on its estimate
that it had limited relevant historical data regarding the volatility of its stock price on which to base a meaningful estimate of expected
volatility. 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
2022
2021
Weighted-average fair value of options granted
$ 4.72
$ 4.97
Expected terms (in years)
6.11
5.00 – 6.11
Expected volatility
68 – 72 %
69 – 74 %
Risk-free interest rate
1.54 – 3.70 %
0.39 – 0.45 %
Dividend yield
-
-
F- 27
The
following table summarizes information about stock options outstanding and exercisable at December 31, 2022:
SCHEDULE
OF STOCK OPTION OUTSTANDING AND EXERCISABLE
Options Outstanding
Options Exercisable
Range of
Exercise Prices
Number
Outstanding
Weighted
Average
Remaining
Contractual
Life in Years
Weighted
Average
Exercise
Price
Number
Exercisable
Weighted
Average
Exercise
Price
$ 1.47 - $ 2.23
583,112
4.53
$ 1.97
583,112
$ 1.97
$ 2.40 - $ 3.50
33,443
4.92
$ 2.84
25,631
$ 2.64
$ 3.95
310,000
3.25
$ 3.95
310,000
$ 3.95
$ 4.08 - $ 6.30
550,850
5.11
$ 5.84
518,417
$ 5.90
$ 6.75 - $ 7.30
405,000
7.67
$ 7.18
257,625
$ 7.29
$ 7.37 - $ 7.79
269,623
5.53
$ 7.54
138,249
$ 7.47
$ 7.87
600,000
2.58
$ 7.87
400,000
$ 7.87
$ 7.89 - $ 8.98
68,173
6.84
$ 8.24
44,735
$ 8.27
$ 8.99
180,000
0.33
$ 8.99
180,000
$ 8.99
$ 12.38
27,500
9.84
$ 12.38
-
$ -
$ 1.47 - $ 12.38
3,027,701
4.48
$ 5.90
2,457,769
$ 5.51
As
of December 31, 2022, there was approximately $ 1,560,000 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 4.88 years.
The stock-based compensation for all stock options was $ 1,130,000 and $ 1,636,000 during the years ended December 31, 2022 and 2021, respectively.
Restricted
Stock Units/Performance Stock Units
RSU
awards are granted subject to certain vesting requirements and other restrictions, including performance and market-based vesting criteria.
The grant date fair value of the RSUs, which has been determined based upon the market value of the Company’s common stock on the
grant date, is expensed over the vesting period of the RSUs.
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:
SCHEDULE
OF RESTRICTED STOCK UNITS ACTIVITY
Number of RSUs
Weighted Average
Grant Date Fair Value
RSUs unvested – January 1, 2022
2,233,202
$ 6.78
RSUs granted
65,615
$ 7.62
RSUs vested
( 237,098 )
$ 6.70
RSUs cancelled/forfeit
-
RSUs unvested at December 31, 2022
2,061,719
$ 6.82
As
of December 31, 2022, the total unrecognized compensation expense related to unvested RSUs was approximately $ 4,205,000 which is expected
to be recognized over a weighted-average period of 0.60 years, based on estimated vesting schedules. The stock-based compensation for
RSUs was $ 6,844,000 and $ 4,022,000 during the years ended December 31, 2022 and 2021, respectively.
F- 28
Grants
During the Year Ended December 31, 2021
During
the year ended December 31, 2021, 300,000 RSUs with a fair market value of $ 2,670,000 were issued to certain employees;
the RSUs vest in full on the third anniversary of the grant date.
During
the year ended December 31, 2021, the Company’s board of directors were granted 38,576 RSUs with a fair market value
of $ 400,000 , which vest in equal quarterly installments over one year.
During
the year ended December 31, 2021, the Company granted 1,567,913 performance stock units (“PSUs”) to members of
its senior management including Mark Baum, Chief Executive Officer, Andrew Boll, Chief Financial Officer, and John Saharek, President
of ImprimisRx , which are subject to the satisfaction of certain market-based and continued service conditions (the “2021 PSUs”).
The 2021 PSUs are separated into four tranches and require that the Company achieve and maintain certain levels of total stockholder
returns (“TSR”) ranging from 50% to 175% per share during the five-year period following the grant date. TSR is 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 table below. With certain limited exceptions, in addition to reaching
the TSR targets, the employee must be employed with the Company on the second anniversary of the grant date in order for the 2021 PSUs
to vest.
SCHEDULE
OF SHARE BASED COMPENSATION PERFORMANCE STOCK UNITS AWARD ACTIVITY
Tranche
Number of Shares
TSR
Target Share Price*
Tranche 1
223,988
50% or greater
$ 11.70
Tranche 2
335,981
100% or greater
$ 15.60
Tranche 3
447,975
150% or greater
$ 19.50
Tranche 4
559,969
175% or greater
$ 21.45
* Target Share Price assumes
that no dividends or like distributions are made to shareholders 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
TSR.
The
fair value of the 2021 PSUs was $ 10,113,000 using a Monte Carlo Simulation with a five-year life, 75 % volatility
and a risk free interest rate of 0.72 % . The fair value amount is being amortized over a two-year derived service period.
A
summary of the Company’s RSU activity and related information for the year ended December 31, 2021 is as follows:
Number of RSUs
Weighted Average
Grant Date Fair Value
RSUs unvested - January 1, 2021
1,601,509
$ 3.14
RSUs granted
1,906,490
$ 6.91
RSUs vested
( 1,274,797 )
$ 2.40
RSUs cancelled/forfeit
-
RSUs unvested at December 31, 2021
2,233,202
$ 6.78
Subsidiary
Stock-Based Transactions
The
Company recognized $ 0 and $ 87,000 in stock-based compensation expense related to subsidiary stock options during the years
ended December 31, 2022 and 2021, respectively.
The
Company recorded 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 CONSULTANTS
2022
2021
For the Year Ended December 31,
2022
2021
Employees – selling, general and administrative
$ 6,669,000
$ 4,800,000
Employees – R&D
689,000
527,000
Directors – selling, general and administrative
462,000
418,000
Consultants – selling, general and administrative
154,000
-
Total
$ 7,974,000
$ 5,745,000
Stock-based compensation
$ 7,974,000
$ 5,745,000
F- 29
Warrants
From
time to time, the Company has issued warrants to purchase shares of the Company’s common stock to investors, lenders, underwriters
and other non-employees for services rendered or to be rendered in the future.
A
summary of warrant activity during the year ended December 31, 2022 is as follows:
SCHEDULE
OF WARRANTS ACTIVITY
Number of Shares Subject to Warrants Outstanding
Weighted Avg.
Exercise Price
Warrants outstanding - January 1, 2022
373,847
$ 2.08
Granted
-
Exercised
( 373,847 )
2.08
Expired
-
-
Warrants outstanding - December 31, 2022
-
$ -
NOTE
16. INCOME TAXES
The
Company is subject to taxation in the United States, California, Florida, Georgia, Illinois, New Jersey, New York, Tennessee and Wisconsin.
The Company’s income tax provision consists of the following for the years ended December 31, 2022 and 2021 are summarized below:
SCHEDULE
OF PROVISION FOR INCOME TAXES
2022
2021
December 31,
2022
2021
Current:
Federal
$
-
$
-
State
75,000
133,000
Total current
$ 75,000
$ 133,000
Deferred:
Federal
$ 871,000
$ ( 425,000 )
State
312,000
( 1,944,000 )
Change in valuation allowance
( 1,182,000 )
2,369,000
Total deferred
-
-
Income tax provision
$ 75,000
$ 133,000
A
reconciliation of income taxes computed by applying the statutory U.S. income tax rate to the Company’s loss before income taxes
to the income tax provision is as follows:
SCHEDULE
OF INCOME TAX RECONCILIATION
2022
2021
December 31,
2022
2021
U.S. federal statutory tax rate
21.00 %
21.00 %
State tax benefit, net
( 2.82 )%
( 3.24 )%
Employee stock-based compensation
1.34 %
7.95 %
Excess Employee Remuneration
( 28.15 )%
( 9.84 )%
Other
1.98 %
2.31 %
W/O of IRC Sec 382 Limited NOLs
- %
( 14.77 )%
W/O of IRC Sec 383 Limited Credits
- %
( 1.71 )%
Reduction of VA for IRC Sec 382 and 383 W/O
- %
16.48 %
Valuation allowance
6.22 %
( 18.92 )%
Effective income tax rate
( 0.43 )%
( 0.74 )%
F- 30
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
2022
2021
December 31,
2022
2021
Deferred tax assets (liabilities):
NOL
$ 9,401,000
$ 12,337,000
Depreciation and amortization
236,000
680,000
Other
349,000
59,000
Research and development credits
90,000
90,000
Deferred stock compensation
945,000
4,642,000
Basis Difference in Eton
( 1,684,000 )
( 2,511,000 )
Sintetica License Agreement
2,162,000
2,329,000
Sparcs License Agreement
2,000
( 1,000 )
Novartis License Agreement
( 13,000 )
( 138,000 )
Basis difference in Melt Loan Value
4,240,000
869,000
Park stock purchase identifiable intangibles
-
( 255,000 )
Limitation Under 163(j)
536,000
-
Section 174 Capital Expenses
594,000
-
ASC 842 Lease Liability
2,427,000
1,856,000
ASC 842 ROU Asset
( 2,263,000 )
( 1,753,000 )
Total deferred tax assets, net
17,022,000
18,204,000
Valuation allowance
( 17,022,000 )
( 18,204,000 )
Net deferred tax liabilities
$ -
$ -
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 $ 1,182,000 and
increased by approximately $ 2,369,000 during 2022 and 2021, respectively.
As
of December 31, 2022, the Company had federal and state net operating loss carryforwards of approximately $ 23,900,000 and $ 45,000,000 ,
respectively, which will begin to expire in 2027 , unless previously utilized, and will begin to expire for state purposes in 2026. In
addition, the Company has federal net operating loss carryforward of $3,900,000 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, 2022 the Company had federal and state research and development credit carryforwards of approximately $ 47,000 and $ 54,000 ,
respectively, which will begin to expire in 2026 , 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.
F- 31
As
of December 31, 2022, 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 valuation allowance.
The
Company did not have any unrecognized tax benefits as of December 31, 2022 and 2021.
These unrecognized tax benefits, if recognized, would not affect the effective tax rate. There was no interest or penalties accrued at
the adoption date and at December 31, 2022.
A
reconciliation of the change in the UTB balance from January 1, 2022 to December 31, 2022 is as follows:
SCHEDULE
OF UNRECOGNIZED TAX BENEFITS
Fed & State Tax
Balance at January 1, 2022
$ -
Additions for tax positions related to current year
-
Additions/(reductions) for tax positions related to prior years
-
Balance at December 31, 2022
$ -
Total unrecognized tax benefits as of December 31, 2022
$ -
The
Tax Cuts and Jobs Act of 2017 (TCJA) included changes to the treatment of research and development expenses under IRC Section 174.
Formerly, a company could deduct research and development expenses under IRC Section 174 as incurred. Effective for tax years
beginning after December 31, 2021, research and development expenses under IRC Section 174 are required to be capitalized, with an
amortization period of five years for costs incurred un the US and 15
years for costs incurred in a non-US jurisdiction. The Company has incurred approximately $ 2,191,000
of US research and development costs during the year ended December 31, 2022.
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 $ 397,000 and $ 282,000 to the plan during the years ended December 31,
2022 and 2021, 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.
Certain
recent developments concerning the Company’s legal proceedings it believes are or were material to its business and other matters
are discussed below:
F- 32
Novel
Drug Solutions et al.
In
April 2018, Novel Drug Solutions, LLC and Eyecare Northwest, PA (collectively “NDS”) filed a lawsuit against the Company
in the U.S. District Court for the District of Delaware asserting various claims, including breach of contract. The claims stem from
an asset purchase agreement between the Company and NDS entered into in 2013. In July 2019, NDS filed a second amended complaint which
added claims related to its purported termination of the asset purchase agreement. In October 2019, NDS voluntarily dismissed all but
two claims, leaving only claims related to the scope and performance of the post-termination obligations to be litigated. On November
8, 2021, following a jury trial, the Company and NDS entered into a voluntary settlement agreement (the “Settlement Agreement”)
to resolve all claims and pending matters related to this lawsuit. During the year ended December 31, 2021, the Company recorded $ 1,500,000 in
selling, general and administrative expenses related to the Settlement Agreement. Except for the one-time payment of $ 1,500,000 the Company
does not expect the Settlement Agreement will have any future material impact on the Company’s consolidated cash flows, financial
position, and results of operations.
Product
and Professional Liability
Product
and professional liability litigation represents an inherent risk to all firms in the pharmaceutical and pharmacy industry. We utilize
traditional third-party insurance policies with regard to our product and professional liability claims. Such insurance coverage at any
given time reflects current market conditions, including cost and availability, when the policy is written.
John
Erick et al.
In
January 2018, John Erick and Deborah Ferrell, successors-in-interest and heirs of Jade Erick, (collectively “Erick”) filed
a lawsuit in the San Diego County Superior Court against Kim Kelly, ND, MPH asserting claims related to the death of Jade Erick. In April
2018, Erick filed an amendment to the lawsuit, naming the Company as a co-defendant. In September 2018, co-defendant Dr. Kelly filed
a cross-complaint against the Company and various entities affiliated with Spectrum Laboratory Products, Inc., Spectrum Chemical Manufacturing
Corp. and Spectrum Pharmacy Products, Inc. (collectively “Spectrum”). The cross-complaint sought indemnity and contribution
from the Company and Spectrum. In November 2021, the lawsuit involving the Company was resolved. There was no impact to the Company’s
consolidated financial position and results of operations as a result of the resolution of this matter.
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. 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 $ 4,274,000 and $ 3,640,000 under these agreements
for commission expenses during the years ended December 31, 2022 and 2021, respectively, which are included in selling, general and administrative
expenses.
F- 33
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, 2022 and 2021, $ 228,000 and $ 251,000 were accrued in accounts payable and accrued expenses
related to these agreements. During the years ended December 31, 2022 and 2021 $ 910,000 and $ 991,000 , respectively, were incurred
under these agreements as royalty 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 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 $ 274,000 and $ 165,000 in cash during
the years ended December 31, 2022 and 2021, respectively, and was due an additional $ 71,000 and $ 30,000 at December 31, 2022 and 2021,
respectively. The Company incurred $ 315,000 and $ 160,000 for royalty expenses related to the Klarity License Agreement during the years
ended December 31, 2022 and 2021, respectively.
Injectable
Asset Purchase Agreement – Related Party
In
December 2019, the Company entered into an asset purchase agreement (the “Lindstrom APA”) with Dr. Lindstrom, a member of
its Board of Directors. Pursuant to the terms of the Lindstrom APA, the Company acquired certain intellectual property and related rights
from Dr. Lindstrom to develop, formulate, make, sell, and sub-license an ophthalmic injectable product (the “Lindstrom Product”).
Under
the terms of the Lindstrom APA, the Company is required to make royalty payments to Dr. Lindstrom ranging from 2% to 3% of net sales,
dependent upon the final formulation and patent protection of the Lindstrom Product sold . In addition, the Company is required to make
certain milestone payments to Dr. Lindstrom including an initial payment of $ 33,000 upon execution of the Lindstrom APA. Dr. Lindstrom
was paid $ 32,000 and $ 28,000 in cash during the year ended December 31, 2022 and 2021, respectively, and was due $ 9,000 and $ 8,000 at
December 31, 2022 and 2021, respectively. The Company incurred $ 33,000 and $ 29,000 for royalty expenses related to the Lindstrom Agreement
during the year ended December 31, 2022 and 2021, respectively.
Presbyopia
Asset Purchase Agreement – Related Party
In
December 2019, the Company entered into an asset purchase agreement (the “Presbyopia APA”) with Richard L. Lindstrom, M.D.,
a member of its Board of Directors. Pursuant to the terms of the Presbyopia APA, the Company acquired certain intellectual property and
related rights from Dr. Lindstrom to develop, formulate, make, sell, and sub-license an ophthalmic topical product to treat presbyopia
(the “Presbyopia Product”).
F- 34
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, 2022 and 2021, and was due $ 0 at December 31, 2022 and 2021. The Company incurred $ 0 for royalty expenses related
to the Presbyopia APA during the years ended December 31, 2022 and 2021.
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 United States. Pursuant
to the Dexycu Agreement , Eyepoint pays 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. Following the preliminary Hospital Outpatient Prospective Payment
System (HOPPS) rule proposed by the Centers for Medicare & Medicaid Services (CMS) in July of 2022, which did not contain an extension
of the pass-through payment period for Dexycu beyond December 31, 2022, the Company entered into a Mutual Termination Agreement (the
“Termination Agreement”) with Eyepoint on October 7, 2022, pursuant to which Eyepoint and the Company agreed (a) that the
Company will continue to support the sale of Dexycu through the fourth quarter of 2022, consistent with the Company’s level of
effort during the January through June 2022 period, (b) to decrease the required minimum quarterly sales levels based on Dexycu unit
demand for the fourth quarter of 2022, and (c) to terminate the Dexycu Agreement, along with ancillary letter agreements, effective January
1, 2023.
During
the years ended December 31, 2022 and 2021, the Company recorded $ 3,866,000 and $ 3,253,000 , respectively, in commission revenues
related to the Dexycu Agreement.
Mayfield
Pharmaceuticals MAY-66 License Termination
In
May 2021, Mayfield terminated the License Agreement (the “TGV License”) with TGV-Health, LLC and affiliated entities (collectively,
“TGV”), pursuant to which it acquired intellectual property rights for use in the women’s health field, related to
Mayfield’s proprietary drug candidate MAY-66. Concurrent with the termination, TGV returned to Mayfield 300,000 shares
of Mayfield’s common stock, constituting all of the equity held by TGV. Mayfield has no outstanding or remaining obligations under
the TGV License.
Mayfield
Pharmaceuticals MAY-44 APA Termination
In
May 2021, Mayfield and Harrow terminated their asset purchase agreement dated January 2020 (the “MAY-44 APA”) for intellectual
property rights associated with Mayfield’s drug candidate MAY-44 with Elle Pharmaceutical LLC (“Elle”). As part of
the termination, Mayfield re-acquired 350,000 shares of its common stock from Elle. Mayfield has no outstanding or remaining
obligations related to the MAY-44 APA.
Stowe
License Termination
In
May 2021, Stowe terminated the License Agreement (the “Stowe License”) with TGV, pursuant to which it acquired intellectual
property rights for use in the ophthalmic field, related to Stowe’s proprietary drug candidate STE-006. Concurrent with the termination,
TGV returned to Stowe 1,750,000 shares of Stowe’s common stock, constituting all of the equity held by TGV. Stowe has
no outstanding or remaining obligations under the Stowe License.
NOTE
19. SEGMENTS AND CONCENTRATIONS
Management
evaluated the Company’s 2021 performance based on operating segments. Segment performance for its two operating segments was based
on segment contribution. Our reportable segments consisted of (i) our commercial stage pharmaceutical business (Pharmaceutical Compounding),
generally including the operations of our ImprimisRx business; and (ii) our start-up operations associated with our pharmaceutical drug
development business (Pharmaceutical Drug Development). Segment contribution for our segments represented net revenues less cost of sales,
R&D expenses, selling and marketing expenses, and select general and administrative expenses. Management did not evaluate the following
items at the segment level:
● Operating
expenses within selling, general and administrative expenses that result from the impact
of corporate initiatives. Corporate initiatives primarily include integration, restructuring,
acquisition and other shared costs;
● Selling,
general and administrative expenses that result from shared infrastructure, including certain
expenses associated with legal matters, our board of directors and principal executive officers,
investor relations and other like shared expenses;
F- 35
● Other
select revenues and operating expenses including R&D expenses, amortization, and asset
sales and impairments, net as not all such information has been accounted for at the segment
level, or such information has not been used by both segments; and
● Total
assets including capital expenditures.
Management
defined segment net revenues as pharmaceutical compounded drug sales, revenues from licenses and other revenues derived from related
agreements.
Cost
of sales within segment contribution includes direct and indirect costs to manufacture formulations and sell products, including active
pharmaceutical ingredients, personnel costs, packaging, storage, royalties, shipping and handling costs, manufacturing equipment and
tenant improvements depreciation, the write-off of obsolete inventory and other related expenses.
Selling,
general and administrative expenses consisted mainly of personnel-related costs, marketing and promotion costs, distribution costs, professional
service costs, insurance, depreciation, facilities costs, transaction costs, and professional services costs, which are general in nature
and attributable to the segment.
Segment net revenues, segment operating expenses and segment contribution information consisted of the following for the years ended
December 31, 2021:
SCHEDULE OF SEGMENT NET REVENUES, SEGMENT OPERATING EXPENSES AND SEGMENT CONTRIBUTION
For the Year Ended December 31, 2021
Pharmaceutical
Pharmaceutical
Compounding
Drug Development
Total
Net revenues
$ 72,476,000
$ -
$ 72,476,000
Cost of sales
( 18,214,000 )
-
( 18,214,000 )
Gross profit
54,262,000
-
54,262,000
Operating expenses:
Selling, general and administrative
27,465,000
-
27,465,000
Research and development
1,088,000
8,674,000
9,762,000
Segment contribution
25,709,000
( 8,674,000 )
17,035,000
Corporate
( 13,689,000 )
Research and development
( 1,322,000 )
Amortization
( 161,000 )
Asset sales and impairments, net
( 249,000 )
Operating income
$ 1,614,000
Beginning
in 2022, due to shifts in the Company’s strategic plans and its organizational structure, management no longer evaluates the Company’s
business in two segments and instead focuses on the performance of the business as a single operating business.
Concentrations
The
Company has two products that each comprised more than 10% of total revenues during the quarter. These products collectively
accounted for 34 % and 35 % of revenues during the years ended December 31, 2022 and 2021, respectively.
The
Company sells its compounded formulations to a large number of customers. There were no customers who comprised more than 10% of the
Company’s total pharmacy sales for the years ended December 31, 2022 and 2021 , respectively .
The Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 61 %
of active pharmaceutical ingredient purchases during the year ended December 31, 2022, and 74 % during the year ended December 31, 2021.
F- 36
NOTE
20. SUBSEQUENT EVENTS
In
January 2023, 23,000 RSUs granted in January 2020 to Andrew R. Boll, the Company’s Chief Financial Officer, vested, and 13,398 shares
the Company’s common stock were issued to Mr. Boll, net of 9,602 shares of common stock withheld for payroll tax withholdings
totaling $ 142,000 .
In
January 2023, 88,000 RSUs granted in January 2020 to Mark L. Baum, the Company’s Chief Executive Officer, vested, and 52,821 shares
the Company’s common stock were issued to Mr. Baum, net of 35,179 shares of common stock withheld for payroll tax withholdings
totaling $ 519,000 .
Closing
of BR Loan and Fab 5 Acquisition - ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE
In
January 2023, the Company closed the Fab 5 Acquisition. At the time of closing the Company made a one-time payment of $ 130,000,000 ,
with up to another $ 45,000,000 due in a milestone payment related to the timing of the commercial availability of TRIESENCE.
At closing the Company entered into a transition period, where Novartis will continue to sell the Fab 5 Products on the
Company’s behalf and transfer the net profit from the sale of the Fab 5 Products to the Company until the time the
Fab 5 Products at transferred to the Company.
The
Company funded the initial purchase price payable at closing of the Fab 5 Acquisition with (i) proceeds of a $ 59,750,000
principal amount borrowing pursuant to the BR Loan (see Note 13), which was drawn at closing of the Fab 5 Acquisition, along with cash on hand
(including cash provided by certain financing activities during 2022).
Overallotment
Exercise of 2027 Notes
In
January 2023, the Company issued an additional $ 5,250,000
aggregate principal amount of the 2027 Notes (see Note 13) upon the exercise in full of the underwriters’ option to purchase
the additional notes. As of the closing of the issuance of the additional 2027 Notes, a total of $ 40,250,000
aggregate principal amount of the 2027 Notes have been issued.
The
Company has performed an evaluation of events occurring subsequent to December 31, 2022 through the filing date of this Annual Report
and determined that no subsequent events have occurred that would require recognition in the consolidated financial statements or disclosures
in the notes thereto, other than as disclosed in the accompanying notes.
F- 37
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.