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, 2021, 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, 2021, 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, 2021.
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, 2021, 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 2022
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 2022 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 2022 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 2022 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 2022 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 to be UPDATED BY HARROW
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 designating the Series B Cumulative Preferred Stock of the Company (incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of the Company filed with the Securities and Exchange Commission on May 5, 2021).
4.1*
Description of the Company’s Securities
4.2
Indenture, dated as of April 20, 2021, by and between the Company 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 the Company filed with the Securities and Exchange Commission on April 20, 2021).
4.3
First Supplemental Indenture, dated as of April 20, 2021, by and between the Company 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 the Company filed with the Securities and Exchange Commission on April 20, 2021).
4.4
Form of 8.625% Senior Note due 2026 (included in Exhibit 4.3).
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#
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 Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on April 26, 2016)
10.8#
Employment Agreement, dated as of April 25, 2016, by and between Imprimis Pharmaceuticals, Inc. and Andrew R. Boll (incorporated herein by reference to Exhibit 10.4 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on April 26, 2016)
10.9#
Employment Agreement, dated as of April 25, 2016, by and between Imprimis Pharmaceuticals, Inc. and John P. Saharek (incorporated herein by reference to Exhibit 10.7 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on April 26, 2016)
10.10
License Agreement dated April 1, 2017 between Imprimis Pharmaceuticals, Inc. and Richard L. Lindstrom, M.D. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on April 6, 2017)
10.11
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)
10.12
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)
10.13#
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)
10.14#
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)
10.15#
Consulting Agreement dated May 1, 2017 between Eton Pharmaceuticals, Inc. and John P. Saharek (incorporated herein by reference to Exhibit 10.10 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on August 10, 2017)
10.16
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)
10.17
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)
10.18
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)
10.19#
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)
10.20#
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)
10.21#
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)
55
10.22
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)
10.23
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)
10.24
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)
10.25
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)
10.26#
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)
10.27#
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)
10.28#
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)
10.29
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)
10.30
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)
10.31
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)
10.32
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)
10.33#
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)
10.34#
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)
10.35#
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)
10.36
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).
10.37
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).
10.38#
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).
10.39#
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).
10.40#
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).
56
10.41
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).
10.42
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).
10.43+
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).
10.44
Securities Purchase Agreement, dated as of May 5, 2021, by and between the Company and B. Riley Securities, Inc. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed with the Securities and Exchange Commission on May 5, 2021).
10.45+
License and Supply Agreement, dated as of July 25, 2021, by and between the Company and Sintetica, S.A. (incorporated herein by reference to Exhibit 10.2+ to the Current Report on Form 10-Q of the Company filed with the Securities and Exchange Commission on August 10, 2021).
10.46#
First Amendment to the Harrow Health, Inc. 2017 Incentive Stock and Awards Plan (incorporated herein by reference to Appendix A to the Company’s Definitive Proxy Statement filed with the SEC on April 23, 2021).
10.47
Loan and Security Agreement, dated September 1, 2021, by and between the Company and Melt Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed with the Securities and Exchange Commission on September 2, 2021).
10.48+
Basic Sale and Purchase Agreement, dated as of August 18, 2021, by and between the Company and Wakamoto Pharmaceutical Co., Ltd. (incorporated herein by reference to Exhibit 10.3+ to the Current Report on Form 10-Q of the Company filed with the Securities and Exchange Commission on November 9, 2021).
10.49+
License Agreement, dated as of August 18, 2021, by and between the Company and Wakamoto Pharmaceutical Co., Ltd. (incorporated herein by reference to Exhibit 10.4+ to the Current Report on Form 10-Q of the Company filed with the Securities and Exchange Commission on November 9, 2021).
10.50*+
Expansion Term Letter Agreement between Eyepoint Pharmaceuticals, Inc. and ImprimisRx, LLC dated December 6, 2021.
10.51*
Asset Purchase Agreement, dated as of December 17, 2021, by and between the Company and Novartis Technology, LLC and Novartis Ophthalmics AG
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, 2021 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
10, 2022
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
10, 2022
Mark
L. Baum
(Principal
Executive Officer)
/s/
Andrew R. Boll
Chief
Financial Officer and Corporate Secretary
March
10, 2022
Andrew
R. Boll
(Principal
Accounting and Financial Officer)
/s/
Robert J. Kammer
Director
March
10, 2022
Robert
J. Kammer
/s/
Teresa F. Sparks
Director
March
10, 2022
Teresa
F. Sparks
/s/
Richard L. Lindstrom
Director
March
10, 2022
Richard
L. Lindstrom
/s/
R. Lawrence Van Horn
Director
March
10, 2022
R.
Lawrence Van Horn
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, 2021 and 2020
F-3
Consolidated Statements of Operations for the years ended December 31, 2021 and 2020
F-4
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2021 and 2020
F-5
Consolidated Statements of Cash Flows for the years ended December 31, 2021 and 2020
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, 2021 and 2020, the related consolidated statements of operations, stockholders’ equity and cash flows for
each of the two years in the period ended December 31, 2021, 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, 2021 and 2020, and the results of
its operations and its cash flows for each of the two years in the period ended December 31, 2021, 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.
Accounting
for Investments in Melt Pharmaceuticals, Inc.
Critical
Audit Matter Description
As
described in Notes 2 and 4 to the consolidated financial statements, the Company has investments in Melt Pharmaceuticals, Inc. (“Melt”)
which it records under the equity method of accounting. The structure and related agreements between the Company and Melt need to be
evaluated for consolidation, including determining whether Melt is a variable interest entity (“VIE”), and if so, whether
the Company is the primary beneficiary. This assessment was performed at the formation of Melt and upon the occurrence of reconsideration
events. This determination requires significant judgment by management.
As
of December 31, 2021, the carrying value of the Company’s investments in Melt was $11.1 million.
We
identified the accounting for the Company’s investments in Melt, including the primary beneficiary assessment upon the occurrence
of reconsideration events, as a critical audit matter given the complex nature of the relevant accounting guidance, as well as the significant
judgment required by management. This required a high degree of auditor judgment and an increased extent of audit effort due to the nature
and complexity of the agreements between the Company and Melt.
How
the Critical Audit Matter Was Addressed in the Audit
Our
audit procedures related to the accounting determination for the investments in Melt, including the primary beneficiary assessment upon
the occurrence of reconsideration events, included obtaining an understanding of management’s assessment of the accounting treatment
of the investments through examination of the related agreements and evaluation of management’s analysis of the significant terms
and characteristics of the investments, the relevant accounting guidance and conclusions. We evaluated management’s conclusions
regarding the accounting for the investments in Melt and considered whether management appropriately determined if Melt is a variable
interest entity, and if so, appropriately determined the primary beneficiary by considering contractual arrangements of Melt to evaluate
if the Company has the power to direct activities and the obligation to absorb losses of Melt or the right to receive benefits from Melt
that could be significant to the variable interest.
We
also evaluated evidence obtained in other areas of the audit to determine if there were additional reconsideration events that had not
been identified by the Company, including, among others, reading board minutes of Melt and reading and analyzing all relevant provisions
of the agreements between the Company and Melt. We further assessed the completeness and accuracy of management’s classification
and disclosure of the Company’s investments in Melt.
/s/
KMJ Corbin & Company LLP
We
have served as the Company’s auditor since 2007.
Irvine,
California
March 10, 2022
F- 2
HARROW
HEALTH, INC.
CONSOLIDATED
BALANCE SHEETS
(In
thousands, except share data)
December
31,
2021
2020
ASSETS
Current
assets
Cash
and cash equivalents, including restricted cash of $ 200 at December 31, 2020
$ 42,167
$ 4,301
Investment
in Eton Pharmaceuticals
8,503
28,455
Accounts
receivable, net
4,470
2,662
Inventories
4,217
3,962
Prepaid
expenses and other current assets
1,305
1,602
Total
current assets
60,662
40,982
Property,
plant and equipment, net
3,141
3,868
Capitalized
software development costs, net
1,313
585
Operating
lease right-of-use assets
5,935
6,799
Intangible
assets, net
15,813
1,939
Investment
in Surface Pharmaceuticals
-
1,314
Investment
in Melt Pharmaceuticals
11,133
1,655
Investments
Goodwill
332
332
TOTAL
ASSETS
$ 98,329
$ 57,474
LIABILITIES
AND STOCKHOLDERS’ EQUITY
Current
liabilities
Accounts
payable and accrued expenses
$ 6,337
$ 3,932
Accrued
payroll and related liabilities
3,089
2,315
Deferred
revenue and customer deposits
16
66
Current
portion of loans payable, net of unamortized debt discount
-
3,898
Current
portion of operating lease obligations
272
580
Current
portion of finance lease obligations
8
8
Total
current liabilities
9,722
10,799
Operating
lease liabilities, net of current portion
6,012
6,652
Finance
lease obligations, net of current portion
10
17
Accrued
expenses, net of current portion
-
800
Loans
payable, net of current portion and unamortized debt discount
71,654
12,378
TOTAL
LIABILITIES
87,398
30,646
Commitments
and contingencies
-
-
STOCKHOLDERS’
EQUITY
Common
stock, $ 0.001 par value, 50,000,000 shares authorized, 26,902,763 and 25,749,875 shares issued and outstanding at December 31, 2021
and December 31, 2020, respectively
27
26
Additional
paid-in capital
106,666
104,557
Accumulated
deficit
( 95,407 )
( 77,400 )
TOTAL
HARROW HEALTH STOCKHOLDERS’ EQUITY
11,286
27,183
Noncontrolling
interests
( 355 )
( 355 )
TOTAL
STOCKHOLDERS’ EQUITY
10,931
26,828
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 98,329
$ 57,474
The
accompanying notes are an integral part of these consolidated financial statements
F- 3
HARROW
HEALTH, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(In
thousands, except for share and per share data)
For
the Years Ended
December
31,
2021
2020
Revenues:
Product
sales, net
$ 69,104
$ 48,479
Other
revenues
3,372
392
Total
revenues
72,476
48,871
Cost
of sales
( 18,214 )
( 14,463 )
Gross
profit
54,262
34,408
Operating
expenses:
Selling,
general and administrative
41,315
31,247
Research
and development
11,084
2,413
Impairment
of long-lived assets
249
363
Total
operating expenses
52,648
34,023
Income
from operations
1,614
385
Other
income (expense):
Interest
expense, net
( 5,436 )
( 2,236 )
Equity
in losses of unconsolidated entities
( 5,334 )
( 4,746 )
Investment
(loss) gain from investment in Eton Pharmaceuticals, net
( 10,126 )
3,255
Loss
on early extinguishment of debt
( 756 )
-
Gain
on forgiveness of PPP loan
1,967
-
Other
income (expense), net
197
( 73 )
Total
other expense, net
( 19,488 )
( 3,800 )
Loss
before income tax provision
( 17,874 )
( 3,415 )
Income
tax provision, net
( 133 )
( 4 )
Total
net loss including noncontrolling interests
( 18,007 )
( 3,419 )
Net
loss attributable to noncontrolling interests
-
62
Net
loss attributable to Harrow Health, Inc.
$ ( 18,007 )
$ ( 3,357 )
Preferred
dividends and accretion of preferred stock issuance costs
( 472 )
-
Net
loss attributable to common stockholders
$ ( 18,479 )
$ ( 3,357 )
Basic
and diluted net loss per share of common stock
$ ( 0.69 )
$ ( 0.13 )
Weighted
average number of shares of common stock outstanding, basic and diluted
26,757,451
25,895,352
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, 2021 and 2020
(In
thousands, except for share data)
Total
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, 2019
-
$ -
25,526,931
$ 26
$ 101,728
$ ( 74,043 )
$ 27,711
$ ( 293 )
$ 27,418
Issuance
of common stock in connection with:
Exercise
of employee stock-based options
-
-
7,159
-
( 29 )
-
( 29 )
-
( 29 )
Exercise
of warrants
Exercise
of warrants , Shares
Shares
withheld related to net share settlement of equity awards
Shares
withheld related to net share settlement of equity awards , shares
Issuance
of preferred shares, net of discounts and issuance costs
Issuance
of preferred shares, net of discounts and issuance costs, shares
Redemption
of preferred shares
Redemption
of preferred shares, shares
Payment
of preferred dividends
Vesting
of RSUs
-
-
185,785
-
-
-
-
-
-
Stock-based
payment for services provided
-
-
30,000
-
83
-
83
-
83
Stock-based
compensation expense
-
-
-
-
2,775
-
2,775
-
2,775
Net
loss
-
-
-
-
-
( 3,357 )
( 3,357 )
( 62 )
( 3,419 )
Balance
at December 31, 2020
-
$ -
25,749,875
$ 26
$ 104,557
$ ( 77,400 )
$ 27,183
$ ( 355 )
$ 26,828
Issuance
of common stock in connection with:
Exercise
of employee stock-based options
-
-
25,480
-
65
-
65
-
65
Exercise
of warrants
-
-
311,369
-
-
-
-
-
-
Vesting
of RSUs
-
-
1,207,500
1
( 1 )
-
-
-
-
Shares
withheld related to net share settlement of equity awards
-
-
( 391,461 )
-
( 3,228 )
-
( 3,228 )
-
( 3,228 )
Issuance
of preferred shares, net of discounts and issuance costs
440,000
-
-
-
10,655
-
10,655
-
10,655
Redemption
of preferred shares
( 440,000 )
-
-
-
( 11,000 )
-
( 11,000 )
-
( 11,000 )
Payment
of preferred dividends
-
-
-
-
( 127 )
-
( 127 )
-
( 127 )
Stock-based
compensation expense
-
-
-
-
5,745
-
5,745
-
5,745
Net
loss
-
-
-
-
-
( 18,007 )
( 18,007 )
-
( 18,007 )
Balance
at December 31, 2021
-
$ -
26,902,763
$ 27
$ 106,666
$ ( 95,407 )
$ 11,286
$ ( 355 )
$ 10,931
The
accompanying notes are an integral part of these consolidated financial statements
F- 5
HARROW
HEALTH, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(In
thousands)
For
the Years Ended
December
31,
2021
2020
CASH
FLOWS FROM OPERATING ACTIVITIES
Net
loss (including noncontrolling interests)
$ ( 18,007 )
$ ( 3,419 )
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activities:
Depreciation
and amortization
1,717
1,880
Amortization
of intangible assets
161
167
Amortization
of operating lease right-of-use assets
518
696
Provision
for bad debt expense
35
213
Interest
paid-in-kind on SWK Loan
-
358
Amortization
of debt issuance costs and discount
677
457
Gain
on forgiveness of PPP loan
( 1,967 )
-
Investment
loss (gain) from investment in Eton
10,126
( 3,255 )
Equity
in losses of unconsolidated entities
5,334
4,746
Loss
on sale and disposal of equipment
41
105
Loss
on early extinguishment of loan
706
-
Impairment
of long-lived assets
249
363
Stock
based payment of consulting services
-
83
Stock-based
compensation
5,745
2,775
Changes
in assets and liabilities:
Accounts
receivable
( 1,831 )
( 866 )
Inventories
( 255 )
( 661 )
Prepaid
expenses and other current assets
( 621 )
( 294 )
Accounts
payable and accrued expenses
1,730
( 4,655 )
Accrued
payroll and related liabilities
774
198
Deferred
revenue and customer deposits
( 50 )
9
NET
CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES
5,082
( 1,100 )
CASH
FLOWS FROM INVESTING ACTIVITIES
Net
proceeds from sale of investment in Eton Pharmaceuticals
9,826
-
Issuance
of note receivable, Melt Pharmaceuticals
( 12,592 )
-
Proceeds
from sale and disposal of assets
-
13
Investment
in patent and trademark assets
( 84 )
( 132 )
Purchase
of product NDAs and patents
( 14,050 )
-
Purchases
of property, plant and equipment and capitalized software development costs
( 1,786 )
( 862 )
NET
CASH USED IN INVESTING ACTIVITIES
( 18,686 )
( 981 )
CASH
FLOWS FROM FINANCING ACTIVITIES
Payments
on finance lease obligations
( 7 )
( 8 )
Net
proceeds from 8.625% notes payable, net of costs
71,073
-
Principal
and exit fee payments on SWK loan
( 15,961 )
( 1,497 )
Net
proceeds from PPP loan payable
-
1,967
Proceeds
from SWK debt, net of costs
-
1,000
Payment
of taxes upon vesting of RSUs
( 3,228 )
( 29 )
Proceeds
from exercise of stock options
65
-
Sale
of preferred stock, net of discount and issuance costs
10,655
-
Repayment
of preferred stock
( 11,000 )
-
Payment
of preferred stock dividends
( 127 )
NET
CASH PROVIDED BY FINANCING ACTIVITIES
51,470
1,433
NET
CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
37,866
( 648 )
CASH,
CASH EQUIVALENTS AND RESTRICTED CASH, beginning of year
4,301
4,949
CASH,
CASH EQUIVALENTS AND RESTRICTED CASH, end of year
$ 42,167
$ 4,301
RECONCILIATION
OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH
Cash
and cash equivalents
$ 42,167
$ 4,101
Restricted
cash
-
200
CASH,
CASH EQUIVALENTS AND RESTRICTED CASH AT END OF YEAR
$ 42,167
$ 4,301
SUPPLEMENTAL
DISCLOSURE OF CASH FLOW INFORMATION:
Cash
paid for income taxes
$ 11
$ 4
Cash
paid for interest
$ 4,823
$ 1,791
SUPPLEMENTAL
DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Purchase
of property, plant and equipment included in accounts payable and accrued expenses
$ 123
$ 214
Net
reduction in right-of-use assets and lease obligations due to modifications
$ 346
$ 936
Melt
accounts receivable transferred to note receivable
$ 908
$ -
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, 2021 and 2020
(all
dollar amounts are expressed in thousands, except share and per share data)
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 ophthalmic-focused healthcare company that specializes in the development,
production and sale of innovative medications that offer unique competitive advantages and serve unmet needs in the marketplace through
its subsidiaries and deconsolidated companies. The Company owns one of the nation’s leading ophthalmology-focused pharmaceutical
businesses, ImprimisRx. In addition to wholly owning ImprimisRx, the Company also has non-controlling equity positions in Surface Ophthalmics,
Inc. (“Surface”) and Melt Pharmaceuticals, Inc. (“Melt”), both companies that began as subsidiaries of Harrow.
In 2020, Harrow created Visionology, Inc. (“Visionology”), which recently launched an online eye health platform business.
Harrow also owns royalty rights in various drug candidates being developed by Surface and Melt.
As
of December 31, 2021, the Company suspended the majority of operational efforts related to its subsidiaries Stowe Pharmaceuticals, Inc.
(“Stowe”), Radley Pharmaceuticals, Inc. (“Radley”) and Mayfield Pharmaceuticals, Inc. (“Mayfield”)
to allocate resources in other areas of the Company’s business. The suspension of these operations did not have a material impact
on the financial results of the Company.
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 subsidiaries, as well as Mayfield and Stowe, subsidiaries of which the Company owned 79 % and 70 % of their equity interests,
respectively, as of December 31, 2020. The remaining 21 % of Mayfield was owned by Elle Pharmaceutical, LLC (“Elle”), TGV-Health,
LLC and its affiliated entities (collectively “TGV”) or other consultants. Mayfield was organized to develop women’s
health-focused drug candidates. The remaining 30 % of Stowe was owned by TGV. Stowe was organized to develop ophthalmic drug candidates.
During 2021, the Company gained control of 100% of the equity interests in Stowe and Mayfield. The Company controls 100 % of the equity
interests in Visionology. All inter-company accounts and transactions have been eliminated in consolidation.
The
Company consolidates entities in which it
has a controlling financial interest. The Company assesses control under the Variable Interest Entity (“VIE”) model to
determine whether the Company is the primary beneficiary of that entity’s operations. If an entity is not deemed to be a VIE,
we consolidate entities in which we hold and/or
control, directly or indirectly, more than 50% of the voting rights.
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 and contractual adjustments, renewal periods and discount rates for leases, realizability of inventories, recoverability
of investments, realizability of deferred taxes, fair value of 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.
Segments
The
Company’s chief operating decision-maker is its Chief Executive Officer who makes resource allocatio n decisions and assesses
performance based on financial information presented as operating segments. Management has identified two
operating segments as reportable segments for periods covered by this Annual Report on Form 10-K. See Note 18 for more information
regarding the Company’s reportable segments.
F- 7
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, such as decision-making rights, that are considered as well . 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.
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 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.
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, 2021 and 2020, 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, 2021 and 2020, and has not recognized interest and/or penalties in the consolidated
statements of operations for the years ended December 31, 2021 and 2020. 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 per owner. From time to time 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) gain from its Eton common stock position of $ ( 8,720 )
and $ 3,255 ,
during the years ended December 31, 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 , before deducting underwriting discounts and commissions and other offering expenses payable by
the Company of $ 799 . During the year ended December 31, 2021, the Company recorded a realized loss of $ 1,406 related to the Eton Stock
Sale. Following the Eton Stock Sale and as of December 31, 2021, 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, 2021, the fair market value of Eton’s common stock was
$ 4.29 per share. As of December 31, 2021, the fair market value of the Company’s investment in Eton was $ 8,503 .
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 $ 40 and $ 98 as of December 31, 2021 and 2020, 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 (which is approximately
46 %
of the equity interests as of December 31, 2021) of Melt. 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. The Company’s share of earnings and losses are
based on the Company’s ownership interest of Melt. Any intra-entity profits and losses are eliminated. During the year ended December
31, 2021, the Company reduced 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, 2021 and at the time of entering into the Melt Loan Agreement
(see Note 4), the Company owned 100 %
of the debt owed by Melt. 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 total debt owed by Melt in accordance
with ASC 323. 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, 2021:
SCHEDULE
OF INVESTMENT
Cost
Share
of Equity Method
Paid-in-Kind
In-substance Capital
Net
Carrying
Basis
Losses
Interest
Contributions
value
Common
stock
$ 5,810
$ ( 5,810 )
$ -
$ -
$ -
Loan
13,500
( 2,367 )
576
( 576 )
11,133
$ 19,310
$ ( 8,177 )
$ 576
$ ( 576 )
$ 11,133
The
following table summarizes the Company’s investments in Melt as of December 31, 2020:
Cost
Share
of Equity
Net
Basis
Method
Losses
Carrying
value
Common
stock
$ 5,810
$ ( 4,155 )
$ 1,655
At
December 31, 2021 and 2020, the Company recorded $ 48 and $ 851 , respectively, due from Melt for reimbursable expenses and amounts due
under a Management Services Agreement between the Company and Melt (the “Melt MSA”), which are included in prepaid expenses
and other current assets in the accompanying consolidated balance sheets.
See
Note 4 for more information and related party disclosure regarding Melt.
Investment
in Surface Ophthalmics, Inc. – Related Party
The
Company owns 3,500,000
common shares (which is approximately 20 %
of the equity interests following the close of a round of financing completed by Surface in July 2021) of Surface and uses the equity
method of accounting for this investment, as management has determined that the Company has the ability to exercise significant influence
over the operating and financial decisions of Surface. Under this method, the Company recognizes earnings and losses in Surface in its
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 in 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, 2021:
SCHEDULE OF INVESTMENT
Cost
Share
of Equity
Net
Basis
Method
Losses
Carrying
value
Common
stock
$ 5,320
$ ( 5,320 )
$ -
The
following table summarizes the Company’s investments in Surface as of December 31, 2020:
Cost
Share
of Equity
Net
Basis
Method
Losses
Carrying
value
Common
stock
$ 5,320
$ ( 4,006 )
$ 1,314
See
Note 5 for more information and related party disclosure regarding Surface.
F- 10
Impairment
of Equity Method Investments and Note Receivable
On
a quarterly basis, management assesses whether there are any indicators that the carrying value of the Company’s equity method
investments and note receivable from Melt 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, 2021 and 2020, 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 Development 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.
Business
Combinations
The
Company accounts for business combinations by recognizing the assets acquired, liabilities assumed, contractual contingencies, and contingent
consideration at their fair values on the acquisition date. The purchase price allocation process requires management to make significant
estimates and assumptions, especially with respect to intangible assets, estimated contingent consideration payments and pre-acquisition
contingencies. Examples of critical estimates in valuing certain of the intangible assets the Company has acquired or may acquire in
the future include but are not limited to:
● future
expected cash flows from product sales, support agreements, consulting contracts, other customer
contracts, and acquired developed technologies and patents; and
● discount
rates utilized in valuation estimates.
Unanticipated
events and circumstances may occur that may affect the accuracy or validity of such assumptions, estimates or actual results. Additionally,
any change in the fair value of the acquisition-related contingent consideration subsequent to the acquisition date, including changes
from events after the acquisition date, such as changes in our estimates of relevant revenue or other targets, will be recognized in
earnings in the period of the estimated fair value change. A change in fair value of the acquisition-related contingent consideration
or the occurrence of events that cause results to differ from our estimates or assumptions could have a material effect on the consolidated
financial position, statements of operations or cash flows in the period of the change in the estimate.
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 life intangible asset and are assessed for impairment based on future projected cash
flows as further described below.
F- 11
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.
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.
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.
The Company’s financial instruments include
cash and cash equivalents, restricted cash, investment in Eton, accounts receivable, accounts payable and accrued expenses, accrued payroll
and related liabilities, deferred revenue and customer deposits and the Notes. The carrying amount of these financial instruments, except
for the investment in Eton and the Notes (see Note 13), approximates fair value due to the short-term maturities of these instruments.
The Company’s restricted cash which is comprised of short-term investments are carried at amortized cost, which approximates fair
value.
At
December 31, 2021 and 2020, the Company measured its investment in Eton at fair value 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, 2021 and 2020, the fair market value of the Company’s investment in Eton was $ 8,503
and $ 28,455 ,
respectively.
F- 12
At
December 31, 2021, the carrying value and fair value of the Notes were $ 71,654 and $ 78,810 , respectively. The Notes are classified
as Level 1 instruments as the fair value is determined using quoted market prices in active markets for the same securities.
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 5,646,594 and 5,411,929 at
December 31, 2021 and 2020, 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, 2021 and 2020 was 267,761 and 200,463 ,
respectively.
The
following table shows the computation of basic net loss per share of common stock for the years ended December 31, 2021 and 2020 (in
000’s, except share and per share amounts):
SCHEDULE
OF BASIC AND DILUTED EARNINGS PER COMMON SHARE
For
the Year Ended December 31,
2021
2020
Numerator
– net loss attributable to Harrow Health, Inc. common stockholders
$ ( 18,479 )
$ ( 3,357 )
Denominator
– weighted average number of shares outstanding, basic and diluted
26,757,451
25,895,352
Net
loss per share, basic and diluted
$ ( 0.69 )
$ ( 0.13 )
Recently
Adopted Accounting Pronouncements
In
December 2019, the FASB issued ASU 2019-12, Income Taxes: Simplifying the Accounting for Income Taxes , which simplifies the accounting
for income taxes. This guidance became effective for the Company on January 1, 2021 on a prospective basis. Adoption of this ASU did
not have a material impact on the Company’s consolidated financial statements.
Reclassifications
Certain
prior period items and amounts have been reclassified to conform to the classifications used to prepare the consolidated financial statements
for the current period. These reclassifications had no material impact on the Company’s consolidated financial position, results
of operations, or cash flows as previously reported.
F- 13
NOTE
3. REVENUES
The
Company accounts for contracts with customers in accordance with ASC 606, Revenues from Contracts with Customers. The Company
has two primary streams of revenue: (1) revenue recognized from our sale of products within our pharmacy services and (2) revenue recognized
from intellectual property license and asset purchase agreements.
Product
Revenues
The
Company sells prescription drugs directly through its pharmacy and outsourcing facility network. Revenue from our pharmacy services division
includes: (i) the portion of the price the client pays directly to us, net of any volume-related or other discounts paid back to the
client, (ii) the price paid to us by individuals, and (iii) customer copayments made directly to the pharmacy network. Sales taxes are
not included in revenue. Following the core principles of ASC 606, we have identified the following:
1.
Identify
the contract(s) with a customer: A contract exists with a customer at the time the prescription or order is received by the Company.
2.
Identify
the performance obligations in the contract: The order received contains the performance obligations to be met, in almost all cases
the product the customer is wishing to receive. If we are unable to be meet the performance obligation the customer is notified.
3.
Determine
the transaction price: the transaction price is based on the product being sold to the customer, and any related customer discounts.
These amounts are pre-determined and built into our order management software.
4.
Allocate
the transaction price to the performance obligations in the contract: The transaction price associated with the product(s) being
ordered is allocated according to the pre-determined amounts.
5.
Recognize
revenue when (or as) the entity satisfies a performance obligation: At the time of shipment from the pharmacy or outsourcing facility
the performance obligation has been met.
The
following revenue recognition policy has been established for the pharmacy services division:
Revenues
generated from prescription or office use drugs sold by our pharmacies and outsourcing facility are recognized when the prescription
is shipped. At the time of shipment, the pharmacy services division has performed substantially all of its obligations under its client
contracts and does not experience a significant level of returns or reshipments. Determination of criteria (3) and (4) is based on management’s
judgments regarding the fixed nature of the selling prices of the products delivered and the collectability of those amounts. The Company
records reductions to revenue for discounts at the time of the initial sale. Estimated returns and allowances and other adjustments are
provided for in the same period during which the related sales are recorded and are based on actual returns history. The rate of returns
is analyzed annually to determine historical returns experience. If the historical data we use to calculate these estimates do not properly
reflect future returns, then a change in the allowance would be made in the period in which such a determination is made and revenues
in that period could be materially affected. The Company will defer any revenues received for a product that has not been delivered or
is subject to refund until such time that the Company and the customer jointly determine that the product has been delivered and no refund
will be required.
Commission
Revenues
During
the year ended December 31, 2020, the Company entered into an agreement whereby it is paid a fee calculated based on sales the Company
generates from a pharmaceutical product that is owned by a third party. The revenue earned from this arrangement is recognized at the
time a customer has ordered the pharmaceutical product and it has shipped from the third party (or one of its distributors or affiliates),
at which point there is no future performance obligation required by the Company and no consequential continuing involvement on the Company’s
part to recognize the associated revenue.
Transfer
of Profit Revenues
During
the year ended December 31, 2021, the Company entered into an agreement to purchase the exclusive
commercial rights to assets associated with certain ophthalmic products from another pharmaceutical company (the “Seller”).
During a temporary, six month transition period, the Seller will continue to manufacture and market these products and transfer
the net profit from the sale of the products to the Company. The revenue recognized by the Company from the transfer of net profit is
recognized at the time profit from the products sales has been calculated by the Seller and confirmed by the Company, typically on a
monthly basis, at which point there is no future performance obligation required by the Company and no consequential continuing involvement
on the Company in part to recognize the associated revenue.
F- 14
Intellectual
Property License Revenues
The
Company currently holds five intellectual property license and related agreements in which the Company has promised to grant a license
or sale which provides 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 of time 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, 2021 and 2020, consists of the following:
SCHEDULE
OF DISAGGREGATED REVENUE
For
the Year Ended December 31,
2021
2020
Product
sales, net
$ 69,104
$ 48,479
Commissions
3,253
356
Transfer
of profit
99
-
License
20
36
Total
revenues
$ 72,476
$ 48,871
Deferred
revenue and customer deposits at December 31, 2021 and 2020, were $ 16 and $ 66 , respectively. All deferred revenue and customer deposit
amounts at December 31, 2020 were recognized as revenue during the year ended December 31, 2021.
NOTE
4. 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
January and March 2019, the Company entered into the Melt Series A Preferred Stock Agreement, see also Note 2, under the subheading Investment
in Melt Pharmaceuticals, Inc .
In
February 2019, the Company and Melt entered into the Melt MSA, whereby the Company provides to Melt certain administrative services and
support, including bookkeeping, web services and human resources related activities, and Melt is required to pay the Company a monthly
amount of $ 10 .
As of December 31, 2021 and 2020, the Company was due $ 48
and $ 851 ,
respectively, from Melt for reimbursable expenses and amounts due under the Melt MSA. Melt did not make any payments to the Company during
the year ended December 31, 2021. The Company’s Chief Executive Officer, Mark L. Baum, was previously a member of the Melt board
of directors until his resignation in November 2021. Following Mr. Baum’s departure, the Company no longer has any representation
on Melt’s board of directors.
F- 15
The
unaudited condensed results of operations information of Melt is summarized below:
SCHEDULE
OF CONDENSED INCOME STATEMENT
2021
2020
For
the Year Ended December 31,
2021
2020
Revenues,
net
$ -
$ -
Loss
from operations
6,655
3,907
Net
loss
$ ( 6,655 )
$ ( 3,907 )
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE
OF CONDENSED BALANCE SHEET
2021
2020
At
December 31,
2021
2020
Current
assets
$ 11,278
$ 2,956
Non-current
assets
-
2
Total
assets
$ 11,278
$ 2,958
Total
liabilities
$ 15,732
$ 1,336
Total
preferred stock and stockholders’ (deficit) equity
( 4,454 )
1,622
Total
liabilities and stockholders’ equity
$ 11,278
$ 2,958
Melt
Note Receivable
In
September 2021, the Company entered into a loan and security agreement in the principal amount of $ 13,500 (the “Melt Loan Agreement”),
as lender, with Melt, as borrower. Amounts borrowed under the Melt Loan Agreement bear interest at twelve and one-half percent ( 12.50 %)
per annum, which interest can be paid in-kind at the option of Melt until the maturity date. The Melt Loan Agreement permits Melt to
pay interest only on the principal amount loaned thereunder through the term and all amounts owed will be due and payable on September
1, 2022. Melt may elect to prepay all, but not less than all, of the amounts owed prior to the maturity date at any time without penalty.
Melt
has granted the Company a security interest in substantially all of its personal property, rights and assets, including intellectual
property rights, to secure the payment of all amounts owed under the Melt Loan Agreement. The Melt Loan Agreement contains customary
representations, warranties and covenants, including covenants by Melt limiting additional indebtedness, liens, mergers and acquisitions,
dispositions, investments, distributions, subordinated debt, and transactions with affiliates. The Melt Loan Agreement includes customary
events of default, and upon the occurrence of an event of default (subject to cure periods for certain events of default), all amounts
owed by Melt thereunder may be declared immediately due and payable by the Company, and the interest rate on the loan may be increased
by three percent ( 3 %) per annum.
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 for amounts owed to the Company for reimbursable expenses and amounts due under the Melt MSA
prior to the effective date of the note receivable (see Note 2).
NOTE
5. INVESTMENT IN SURFACE OPHTHALMICS, INC. AND AGREEMENTS - RELATED PARTY TRANSACTIONS
The
Company entered into an asset purchase and license agreement with Surface in 2017 and amended it in April 2018 (the “Surface License
Agreements”). Pursuant to the terms of the Surface License Agreements, the Company assigned and licensed to Surface certain intellectual
property and related rights associated with Surface’s drug candidates (collectively, the “Surface Products”). Surface
is required to make mid-single digit royalty payments to the Company on net sales of the Surface Products while any patent rights remain
outstanding.
As
of December 31, 2021, the Company owned 3,500,000 shares of Surface common stock (approximately 30 % of the issued and outstanding equity
interests). A Company director, Richard L. Lindstrom, and the Company’s Chief Executive Officer, Mark L. Baum, are directors of
Surface. Dr. Lindstrom is a principal of Flying L Partners, an affiliate of a funding investor who purchased the Surface Series A Preferred
Stock.
F- 16
The
unaudited condensed results of operations information of Surface is summarized below:
SUMMARY
OF CONDENSED INCOME STATEMENT
2021
2020
For
the Years Ended December 31,
2021
2020
Revenues,
net
$ -
$ -
Loss
from operations
10,143
8,109
Net
loss
$ ( 10,143 )
$ ( 8,109 )
The
unaudited condensed balance sheet information of Surface is summarized below:
SUMMARY
OF CONDENSED BALANCE SHEET
At
December 31,
2021
2020
Current
assets
$ 21,731
$ 9,074
Non-current
assets
412
45
Total
assets
22,143
9,119
Total
liabilities
$ 1,514
$ 1,666
Total
stockholders’ equity
20,629
7,453
Total
liabilities and stockholders’ equity
$ 22,143
$ 9,119
NOTE
6. RESTRICTED CASH
The
restricted cash at December 31, 2020 consisted of funds in a money market account and held as collateral for additional security for
the Company’s New Jersey facility lease. All restrictions on this cash were released during the year ended December 31, 2021. At
December 31, 2020, the restricted cash was recorded at amortized cost, which approximates fair value.
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, 2021 and
2020 was as follows:
SCHEDULE
OF INVENTORIES
2021
2020
December
31,
2021
2020
Raw
materials
$ 2,441
$ 2,501
Work
in progress
-
17
Finished
goods
1,776
1,444
Total
inventories
$ 4,217
$ 3,962
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
2021
2020
December
31,
2021
2020
Prepaid
insurance
$ 728
$ 160
Other
prepaid expenses
437
401
Receivable
due from Melt
48
851
Deposits
and other current assets
92
190
Total
prepaid expenses and other current assets
$ 1,305
$ 1,602
F- 17
NOTE
9. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment, net at December 31, 2021 and 2020 consisted of the following:
SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT
2021
2020
December
31,
2021
2020
Property,
plant and equipment, net:
Computer
hardware
$ 772
$ 690
Furniture
and equipment
443
418
Lab
and pharmacy equipment
4,056
3,426
Leasehold
improvements
5,703
5,720
Property,
plant and equipment, gross
10,974
10,254
Accumulated
depreciation and amortization
( 7,833 )
( 6,386 )
Property,
plant and equipment, net
$ 3,141
$ 3,868
During
the years ended December 31, 2021 and 2020, the Company disposed of property, plant and equipment with a net book value of $ 41
and a write down of equipment of
$ 150 and $ 105 ,
respectively, related to the discontinued use of certain lab equipment and computer software and hardware and is included in other expense,
net in of the consolidated statements of operations. The Company purchased $ 753 of lab and pharmacy equipment from Eton during the
year ended December 31, 2021. The Company recorded depreciation and amortization expense of $ 1,580
and $ 1,702
during the years ended December 31, 2021 and
2020, respectively.
NOTE
10. CAPITALIZED SOFTWARE DEVELOPMENT COSTS
Capitalized
software development costs at December 31, 2021 and 2020 consisted of the following:
SCHEDULE
OF FINITE LIVED INTANGIBLE ASSETS
2021
2020
December
31,
2021
2020
Capitalized
internal-use software development costs
$ 417
$ 554
Acquired
third-party software license for internal-use
684
126
Total
gross capitalized software for internal-use
1,101
680
Accumulated
amortization
( 569 )
( 432 )
Capitalized
internal-use software in process
781
337
Total
finite lived intangible assets net
$ 1,313
$ 585
The
Company recorded amortization expense of $ 137
and $ 178
related to capitalized software development
costs during the years ended December 31, 2021 and
2020, respectively.
NOTE
11. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at December 31, 2020 consisted of the following:
SCHEDULE OF INTANGIBLE ASSETS
Amortization
periods
Accumulated
Net
(in
years)
Cost
amortization
Impairment
Carrying
value
Patents
17 - 19
years
$ 922
$ ( 93 )
$ ( 363 )
$ 473
Licenses
20
years
50
( 6 )
-
44
Trademarks
Indefinite
356
-
-
356
Customer
relationships
3 - 15
years
1,519
( 454 )
-
1,065
Trade
name
5
years
5
( 5 )
-
-
Non-competition
clause
3 - 4
years
50
( 50 )
-
-
State
pharmacy licenses
25
years
8
( 7 )
-
1
$ 2,917
$ ( 615 )
$ ( 363 )
$ 1,939
During
the year ended December 31, 2020, the Company recorded impairment charges of $ 363 related to patent filings and trademarks that were
abandoned and/or were associated with products the Company was no longer actively selling.
During
the year ended December 31, 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 New Drug Applications (“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
to NVS for the U.S.
rights to the NVS Products and their related intellectual property. 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.
F- 18
The Company’s intangible assets at December
31, 2021 consisted of the following:
Amortization
periods
Accumulated
Net
(in
years)
Cost
amortization
Impairment
Carrying
value
Patents
7 - 19
years
$ 966
$ ( 75 )
$ -
$ 891
Licenses
20
years
100
( 7 )
-
93
Trademarks
Indefinite
359
-
( 99 )
260
Acquired
NDAs
10
years
13,635
-
-
13,635
Customer
relationships
3 - 15
years
1,519
( 586 )
-
933
Trade
name
5
years
5
( 5 )
-
-
Non-competition
clause
3 - 4
years
50
( 50 )
-
-
State
pharmacy licenses
25
years
8
( 7 )
-
1
$ 16,642
$ ( 730 )
$ ( 99 )
$ 15,813
During
the year ended December 31, 2021, the Company recorded impairment charges of $ 99 related to trademarks that were abandoned and/or were
associated with products the Company was no longer actively selling.
Amortization
expense for intangible assets for the years ended December 31, 2021 and 2020 were as follows:
SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
2021
2020
For
the Year Ended December 31,
2021
2020
Patents
$ 26
$ 32
Licenses
2
1
Customer
relationships
133
134
Amortization
of intangible assets
$ 161
$ 167
Estimated
future amortization expense for the Company’s intangible assets at December 31, 2021 is as follows:
SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE
Years
ending December 31,
2022
1,602
2023
1,592
2024
1,592
2025
1,592
2026
1,586
Thereafter
7,589
Intangible
assets
$ 15,553
There
were no changes in the carrying value of the Company’s goodwill during the years ended December 31, 2021 and 2020.
NOTE
12. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses at December 31, 2021 and 2020 consisted of the following:
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
2021
202 0
December
31,
2021
2020
Accounts
payable
$ 5,174
$ 3,645
Other
accrued expenses
49
49
Accrued
interest (see Note 13)
1,114
238
Accrued
exit fee for note payable (see Note 13)
-
800
Total
accounts payable and accrued expenses
6,337
4,732
Less:
Current portion
( 6,337 )
( 3,932 )
Non-current
total accrued expenses
$ -
$ 800
F- 19
NOTE
13. DEBT
8.625%
Senior Notes Due 2026
In
April 2021, the Company closed an offering of $ 50,000 aggregate principal amount of 8.625% senior notes due in April 2026, and in May
2021 issued an additional $ 5,000 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 after deducting underwriting discounts and commissions
and expenses of $ 3,091 . In June 2021, in a further issuance of the April Notes, the Company sold an additional $ 20,000 aggregate principal
amount of such notes (the “June Notes,” and together with the April Notes, the “Notes”), at a price of $ 25.75
per June Note, with interest of $ 278 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 after deducting underwriting discounts and commissions and expenses
of $ 1,158 and a premium on note issuance of $ 322 . 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 Notes are senior unsecured obligations of the Company and rank equally
in right of payment with all of our other existing and future senior unsecured and unsubordinated indebtedness. The Notes are effectively
subordinated in right of payment to all of the Company’s existing and future secured indebtedness and structurally subordinated
to all existing and future indebtedness of the Company’s subsidiaries, including trade payables. The Notes bear interest at a rate
of 8.625 % per annum. Interest on the Notes is payable quarterly in arrears on January 31, April 30, July 31 and October 31 of each year,
commencing on July 31, 2021. The Notes will mature on April 30, 2026. The issuance costs were recorded
as a debt discount and are being amortized as interest expense, net of the amortization of the premium on note issuance, over the term
of the Notes using the effective interest rate method.
Prior
to February 1, 2026, the Company may, at its option, redeem the Notes, in whole at any time or in part from time to time, at a redemption
price equal to 100% of the principal amount of the Notes to be redeemed , plus a make-whole amount, if any, plus accrued and unpaid interest
to, but excluding, the date of redemption. The Company may redeem the Notes for cash in whole or in part at any time at our option on
or after February 1, 2026 and prior to maturity, at a price equal to 100% of their principal amount, plus accrued and unpaid interest
to, but excluding, the date of redemption. On and after any redemption date, interest will cease to accrue on the redeemed Notes.
Interest
expense related to the Notes totaled $ 5,132 for the year ended December 31, 2021, and included amortization of debt issuance costs and
discount of $ 581 for the year ended December 31, 2021.
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 (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 ;
●
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 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.
F- 20
Interest
expense related to the SWK Loan Agreement, as amended, amounted to $ 647 for the year ended December 31, 2021, and $ 1,767 for the year
ended December 31, 2020, and included amortization of debt issuance costs and discounts of $ 96 for the year ended December 31, 2021,
and $ 354 for the year ended December 31, 2020.
In
April 2021, the Company paid $ 15,540 related to all outstanding obligations to SWK under the SWK Loan, including outstanding principal,
accrued interest, accrued exit fee and related expenses and recorded a loss from early extinguishment of $ 756 related to the SWK Loan
during the year ended December 31, 2021.
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 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 in the accompanying consolidated statement of operations for the year ended December 31,
2021.
At
December 31, 2021, future minimum payments under the Company’s Notes were as follows:
SUMMARY OF FUTURE MINIMUM PAYMENTS
Amount
2022
$ 6,469
2023
6,469
2024
6,469
2025
6,469
2026
77,158
Total
minimum payments
103,034
Less:
amount representing interest payments
( 28,034 )
Notes
payable, gross
75,000
Less:
unamortized discount, net of premium
( 3,346 )
Notes
payable, net of unamortized discount
$ 71,654
NOTE
14. LEASES
The
Company leases office and laboratory space under the non-cancelable operating leases listed below. These lease agreements have remaining
lease terms between one to four years and contain various clauses for renewal at the Company’s option.
● An
operating lease for 10,200 square feet of office space in San Diego, California that expired
in December 2021 ;
● An
operating lease for 5,789
square
feet of office space in Carlsbad, California, which commenced in January 2022 and will expire
in July 2027 . Since the commencement date of this lease occurred after December 31, 2021,
right-of-use assets and operating lease liabilities associated with it are not included in
our consolidated balance sheet at December 31, 2021 ;
● An
operating lease for 35,326 square feet of lab, warehouse and office space in Ledgewood, New
Jersey that expires in July 2026 , with an option to extend the term for two additional five-year
periods . This includes an amendment that was made effective July 2020 that extended the term
of the original lease and added 1,400 of additional square footage to the lease and another
amendment entered into in May 2021 that extended the term of the lease to July 2027 and added
8,900 square feet of space; and
● An
operating lease for 5,500 square feet of office space in Nashville, Tennessee, that expires
in December 2024 , with an option to extend the term for two additional five-year periods .
During
the year ended December 31, 2021, the Company terminated its operating lease for 10,200 square feet of office space in San Diego, California,
that had an expiration date in December 2021 .
At
December 31, 2021 and 2020, the weighted-average discount rate and the weighted-average remaining lease term for the operating leases
held by the Company were 6.3 % and 6.3 % and 14.6 and 11.2 years, respectively.
During
the years ended December 31, 2021 and 2020, cash paid for amounts included for the operating lease liabilities was $ 1,000 and $ 1,052 ,
respectively, and the Company recorded operating lease expense of $ 912 and $ 1,066 , respectively, included in selling, general and administrative
expenses.
F- 21
Future
lease payments under operating leases as of December 31, 2021 were as follows :
SCHEDULE
OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES
Operating
Leases
2022
$ 674
2023
740
2024
760
2025
579
2026
594
Thereafter
6,378
Total
minimum lease payments
9,725
Less:
amount representing interest payments
( 3,441 )
Total
operating lease liabilities
6,284
Less:
current portion, operating lease liabilities
( 272 )
Operating
lease liabilities, net of current portion
$ 6,012
The
Company has a finance lease for equipment which requires monthly payments of $ 1 through January 2024.
Future
lease payments under the finance lease as of December 31, 2021 were as follows :
SCHEDULE
OF FUTURE LEASE PAYMENT UNDER FINANCE LEASE
Finance
Lease
2022
$ 9
2023
9
2024
1
Total
minimum lease payments
19
Less:
amount representing interest payments
( 1 )
Present
value of future minimum lease payments
18
Less:
current portion, finance lease obligation
( 8 )
Finance
lease obligation, net of current portion
$ 10
At
December 31, 2021 and 2020, the weighted-average discount rate and the weighted-average remaining lease term for the finance lease held
by the Company were 6.36 % and 6.36 % and 2.08 and 3.08 years, respectively.
For
the years ended December 31, 2021 and 2020:
● amortization
expense related to the equipment held under the finance lease obligations was $ 8 and $ 8 ,
respectively; and
● cash
paid and expense recognized for interest expense related to the finance lease obligation
was $ 1 and $ 2 , respectively.
NOTE
15. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Preferred
Stock
At
December 31, 2021 and 2020, the Company had 5,000,000 shares of preferred stock, $ 0.001 par value, authorized and no shares of preferred
stock issued and outstanding.
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 . 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 . During the year ended December 31, 2021, the Company recorded preferred stock cash dividends and deemed dividends equal to $ 472 .
F- 22
Common
Stock
At
each of December 31, 2021 and 2020, the Company had 50,000,000 shares of common stock, $ 0.001 par value, authorized.
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 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 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 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.
Issuances
During the Year Ended December 31, 2020
During
the year ended December 31, 2020:
● the
Company issued 30,000 shares of its restricted common stock, with an initial fair value of
$ 167 , as consideration for commission expenses incurred during the year ended December 31,
2019 and the year ended December 31, 2020;
● the
Company issued 4,161 shares of its common stock upon the cashless exercise of options to
purchase 16,750 shares of common stock, with exercise prices ranging from $ 1.70 to $ 4.05
per share, net of 3,564 shares of common stock withheld for payroll tax withholdings;
● the
Company issued 2,998 shares of its common stock upon the exercise of options to purchase
2,998 shares of common stock, with exercise prices ranging from $ 3.04 to $ 3.20 per share,
and paid $ 8 related to payroll tax withholdings;
● the
Company issued 185,785 shares of its common stock underlying RSUs held by directors that
resigned. The RSUs had previously vested, including 26,721 RSUs during the year ended December
31, 2020, but the issuance and delivery of the shares were deferred until the director resigned;
and
● 35,224
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 resignation of a director.
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
purposes of the Plans are to attract and retain directors, officers, consultants, advisors and employees whose services are considered
valuable, to encourage a sense of proprietorship and to stimulate an active interest of such persons in the Company’s development
and financial success. Under the Plans, the Company is authorized to issue incentive stock options intended to qualify under Section
422 of the Internal Revenue Code of 1986, as amended, non-qualified stock options, restricted stock units and restricted stock. The Plans
are administered by the Compensation Committee of the Company’s Board of Directors. The Company had 2,399,649
shares available for future issuances under
the 2017 Plan at December 31, 2021.
F- 23
Stock
Options
A
summary of stock option activity under the Plan for the year ended December 31, 2021 is as follows:
SCHEDULE OF STOCK OPTION PLAN ACTIVITY
Number
of shares
Weighted
Avg. Exercise Price
Weighted
Avg. Remaining Contractual Life
Aggregate
Intrinsic Value
Options
outstanding - January 1, 2021
3,030,033
$ 5.43
Options
granted
77,000
$ 8.13
Options
exercised
( 25,480 )
$ 2.62
Options
cancelled/forfeit
( 42,007 )
$ 5.80
Options
outstanding - December 31, 2021
3,039,546
$ 5.52
4.78
$ 9,561
Options
exercisable
2,461,824
$ 5.10
4.53
$ 8,778
Options
vested and expected to vest
2,981,774
$ 5.48
4.76
$ 9,483
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, 2021, based on the closing price of the Company’s common stock of $ 8.64 on that date.
The
intrinsic value of the options exercised in 2021 was $ 146 .
During
the year ended December 31, 2021, the Company granted stock options to certain employees and a consultant. The stock options were granted
with an exercise price equal to the current market price of the Company’s common stock, as reported by the securities exchange
on which the common stock was then listed, at the grant date and have contractual terms of 10 years. Vesting terms for options granted
to employees and consultants during the year ended December 31, 2021 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 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.
F- 24
The
table below illustrates the fair value per share determined using the Black-Scholes-Merton option pricing model with the following assumptions
used for valuing options granted to employees:
SCHEDULE OF FAIR VALUE ASSUMPTIONS
2021
2020
Weighted-average
fair value of options granted
$ 4.97
$ 3.86
Expected
terms (in years)
5.00
- 6.11
0.50
- 6.11
Expected
volatility
69
– 74 %
67
– 71 %
Risk-free
interest rate
0.39
– 0.45 %
0.34
– 1.64 %
Dividend
yield
-
-
The
following table summarizes information about stock options outstanding and exercisable at December 31, 2020:
SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE
Weighted
Average
Weighted
Weighted
Remaining
Average
Average
Number
Contractual
Exercise
Number
Exercise
Range
of Exercise Prices
Outstanding
Life
in Years
Price
Exercisable
Price
$ 1.47
- $ 2.60
750,955
4.61
$ 2.06
750,763
$ 2.06
$ 2.76
- $ 4.66
505,000
4.71
$ 3.99
459,370
$ 3.98
$ 5.49
- $ 6.36
470,350
6.09
$ 6.12
414,645
$ 6.14
$ 6.64
- $ 8.99
1,313,241
4.43
$ 7.87
837,046
$ 7.93
$ 1.47
- $ 8.99
3,039,546
4.78
$ 5.52
2,461,824
$ 5.10
As
of December 31, 2021, there was approximately $ 1,397 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 5.1 years. The stock-based
compensation for all stock options was $ 1,636 and $ 1,579 during the years ended December 31, 2021 and 2020, 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, 2020
During
the year ended December 31, 2020, 161,000 RSUs with a fair market value of $ 1,025 were issued to certain employees; the RSUs vest in
full on the third anniversary of the grant date.
During
the year ended December 31, 2020, the Company’s board of directors were granted 90,524 RSUs with a fair market value $ 511 which
vest on a quarterly basis, over a one-year term in equal installments, subject to the director’s continued service at the vesting
date, but the issuance and delivery of these shares are deferred until the director resigns.
A
summary of the Company’s RSU activity and related information for the year ended December 31, 2020 is as follows:
Number
of RSUs
Weighted
Average Grant
Date Fair Value
RSUs
unvested - January 1, 2020
1,411,930
$ 2.76
RSUs
granted
251,524
$ 6.11
RSUs
vested
( 61,945 )
$ 6.46
RSUs
cancelled/forfeited
-
RSUs
unvested at December 31, 2020
1,601,509
$ 3.14
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 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 , which
vest in equal quarterly installments over one year.
F- 25
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
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:
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY
Number
of RSUs
Weighted Average Grant Date
Fair Value
RSUs
unvested - January 1, 2021
1,601,509
$ 3.14
RSUs
granted
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
As
of December 31, 2021, the total unrecognized compensation expense related to unvested RSUs was approximately $ 10,550 which is expected
to be recognized over a weighted-average period of 1.48 years, based on estimated vesting schedules. The stock-based compensation for
RSUs was $ 4,022 and $ 1,167 during the years ended December 31, 2021 and 2020, respectively.
Subsidiary
Stock-Based Transactions
The
Company recognized $ 87 and $ 26 in stock-based compensation expense related to subsidiary stock options during the years ended December
31, 2021 and 2020, 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
For
the Year Ended December 31,
2021
2020
Employees
– selling, general and administrative
$ 4,800
$ 2,289
Employees
– R&D
527
Directors
– selling, general and administrative
418
473
Consultants
– selling, general and administrative
-
96
Total
$ 5,745
$ 2,858
Warrants
From
time to time, the Company issues warrants to purchase shares of the Company’s common stock to investors, lenders (see Note 13),
underwriters and other non-employees for services rendered or to be rendered in the future.
F- 26
A
summary of warrant activity during the year ended December 31, 2021 is as follows:
SCHEDULE OF WARRANTS ACTIVITY
Number
of Shares Subject to Warrants Outstanding
Weighted
Avg. Exercise Price
Warrants
outstanding - January 1, 2021
780,386
$ 2.12
Granted
-
Exercised
( 406,539 )
2.16
Expired
-
-
Warrants
outstanding and exercisable - December 31, 2021
373,847
$ 2.08
Weighted
average remaining contractual life of the outstanding warrants in years - December 31, 2021
2.55
All
warrants outstanding as of December 31, 2021 are included in the following table:
SCHEDULE OF WARRANTS OUTSTANDING AND WARRANTS EXERCISABLE
Warrants
Outstanding and Exercisable
Warrants
Exercise
Expiration
Warrant
Series
Issue
Date
Outstanding
Price
Date
Lender
warrants (see Note 13)
7/19/2017
373,847
$ 2.08
7/19/2024
373,847
$ 2.08
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 (benefit) for income taxes for the years ended December 31, 2021 and 2020 are summarized below:
SCHEDULE OF PROVISION FOR INCOME TAXES
2021
2020
December
31,
2021
2020
Current:
Federal
$ -
$ -
State
133
4
Total
current
$ 133
$ 4
Deferred:
Federal
$ ( 425 )
$ ( 771 )
State
( 1,944 )
138
Change
in valuation allowance
2,369
633
Total
deferred
-
-
Income
tax provision (benefit)
$ 133
$ 4
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
2021
2020
December
31,
2021
2020
U.S.
federal statutory tax rate
21.00 %
21.00 %
State
tax benefit, net
( 3.24 )%
( 0.11 )%
Employee
stock-based compensation
7 . 95 %
5.52 %
Other
( 7.53 )%
( 0.38 )%
Write
off of NOLs due to previous change in ownership
( 14.77 )%
0.00 %
Write
off of credits due to previous change in ownership
( 1.71 )%
0.00 %
Reduction
of valuation allowance for write off of NOLs and credits due to previous change in ownership
16.48 %
0.00 %
Valuation
allowance
( 18.82 )%
( 26.14 )%
Effective
income tax rate
( 0.74 )%
( 0.11 )%
F- 27
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
2021
2020
December
31,
2021
2020
Deferred
tax assets (liabilities):
NOL
$ 12,337
$ 19,678
Depreciation
and amortization
680
535
Other
59
413
Research
and development credits
90
596
Deferred
stock compensation
4,642
4,024
Basis
Difference in Melt
-
( 398 )
Basis
Difference in Surface
-
( 502 )
Basis
Difference in Eton
( 2,511 )
( 8,626 )
Capital
Losses
-
63
Sintetica
License Agreement
2,329
-
License Agreement
( 1 )
-
Novartis
License Agreement
( 138 )
-
Park
stock purchase identifiable intangibles
( 255 )
( 274 )
Basis difference in Melt loan
869
-
Limitation
Under 163(j)
-
195
Operating
lease liabilities
1,856
2,192
Operating
lease right-of-use assets
( 1,753 )
( 2,061 )
Total
deferred tax assets, net
18,204
15,835
Valuation
allowance
( 18,204 )
( 15,835 )
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 increased by approximately $ 2,369
and increased by approximately $ 633
during 2021 and 2020, respectively.
As
of December 31, 2021, the Company had federal and state net operating loss carryforwards of approximately $ 34,400 and $ 53,200 , 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 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, 2021 the Company had federal and state research and development credit carryforwards of approximately $ 47 and $ 54 , 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- 28
As
of December 31, 2021, the Company determined that it had net operating loss carryforwards of approximately $ 12,600
and state net operating loss carryforwards
of approximately $ 9,400
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
of federal credit and $ 300
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, 2021 and 2020, all of which is offset by a full valuation allowance.
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, 2021.
A
reconciliation of the change in the UTB balance from January 1, 2021 to December 31, 2021 is as follows:
SCHEDULE
OF UNRECOGNIZED TAX BENEFITS
Fed
& State Tax
Balance
at January 1, 2021
$ -
Additions
for tax positions related to current year
-
Additions/(reductions)
for tax positions related to prior years
-
Balance
at December 31, 2021
-
Total
unrecognized tax benefits as of December 31, 2021
-
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 $ 282 and $ 272 to the plan during the years ended December 31, 2021 and
2020, respectively.
NOTE
18. COMMITMENTS AND CONTINGENCIES
Legal
Novel
Drug Solutions et al.
In
April 2018, Novel Drug Solutions, LLC and Eyecare Northwest, PA (collectively “NDS”) filed a lawsuit against the Company
in the U.S. District Court 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
in selling, general and administrative expenses related to the Settlement Agreement. Except for the one-time payment of $ 1,500 , 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.
F- 29
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.
General
and Other
In
the ordinary course of business, the Company may face various claims brought by third parties and it may, from time to time, make claims
or take legal actions to assert its rights, including intellectual property disputes, contractual disputes and other commercial disputes.
Any of these claims could subject the Company to litigation.
Indemnities
In
addition to the indemnification provisions contained in the Company’s 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 accrued and recorded in additional paid-in capital of
$ 0
and $ 83
related to stock-based payments for these agreements
during the years ended December 31, 2021 and 2020, respectively, and $ 3,640
and $ 2,434
were incurred under these agreements for commission
expenses during the years ended December 31, 2021 and 2020, respectively, which are included in selling, general and administrative expenses.
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, 2021 and 2020, $ 251
and $ 224
were accrued in accounts payable and accrued
expenses related to these agreements. During the years ended December 31, 2021 and 2020, $ 991
and $ 682 ,
respectively, were incurred under these agreements as royalty expenses.
F- 30
Acquisition
of U.S. Rights to MAXITROL Eye Drops, IOPIDINE and MOXEZA
On
December 17, 2021 (the “Closing Date”), the Company entered into the NVS Agreement (see Note 10), pursuant to which the Company
purchased from NVS the exclusive commercial rights to the NVS Products in the U.S. The Company made a one-time payment of $ 14,050
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 will continue to sell
the NVS Products on the Company’s behalf and transfer 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.
Sintetica
Agreement
In
July 2021, the Company entered into a License and Supply Agreement (the “Sintetica Agreement”) with Sintetica S.A. (“Sintetica”),
pursuant to which Sintetica granted the Company the exclusive license and marketing rights to its patented ophthalmic drug candidate
(“AMP-100”) in the U.S. and Canada.
Pursuant
to the Sintetica Agreement, the Company will pay Sintetica a per unit transfer price to supply AMP-100, along with a per unit royalty
for units sold. The Company is required to pay Sintetica up to $ 18,000 in one-time milestone payments including a $ 5,000 payment (the
“Upfront Payment”) due within 30 days of signing the Sintetica Agreement and the balance of payments due upon achievement
of certain regulatory and commercial milestones. Under the terms of the Sintetica Agreement, Sintetica will be responsible for regulatory
filings for AMP-100 in the U.S. The Upfront Payment along with an additional milestone payment of $ 3,117 was paid and recorded as a R&D
expenses during the year ended December 31, 2021.
Subject
to certain limitations, the term of the Sintetica Agreement is ten years, and allows for a ten-year extension if certain sales thresholds
are met.
Wakamoto
Agreement
In
August 2021, the Company entered into a License Agreement and a Basic Sale and Purchase Agreement (together, the “Wakamoto Agreements”)
with Wakamoto Pharmaceutical Co., Ltd. (“Wakamoto”), pursuant to which Wakamoto granted the Company the exclusive license
and marketing rights to its ophthalmic drug candidate (“MAQ-100”) in the U.S. and Canada.
Pursuant
to the Wakamoto Agreements, Wakamoto will supply MAQ-100 to the Company, and the Company
will pay Wakamoto a per unit transfer price to supply MAQ-100. In addition, the Company is required to pay Wakamoto various one-time
milestone payments totaling up to $ 2,000 upon the achievement of certain regulatory milestones and up to $ 6,200 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, 2021, no amounts have been paid or accrued under the Wakamoto agreement.
Subject
to certain limitations, the term of the Agreements is for five years from the date of the FDA’s market approval of MAQ-100 and
allows for a five-year extension if certain unit sales thresholds are met.
Eyepoint
Commercial Alliance Agreement
In
August 2020, the Company, through its wholly-owned subsidiary ImprimisRx, LLC, entered into a Commercial Alliance Agreement (the “Dexycu
Agreement”) with Eyepoint Pharmaceuticals, Inc. (“Eyepoint”), pursuant to which Eyepoint granted the Company the non-exclusive
right to co-promote DEXYCU ® (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation
following ocular surgery in the United States. Pursuant
to the Dexycu Agreement , Eyepoint will pay the Company a fee calculated based on the quarterly
sales of DEXYCU in excess of predefined volumes to specific customers of the Company in the U.S. Under the terms of the Dexycu
Agreement , the Company shall use commercially reasonable efforts to promote and market DEXYCU in the U.S. In December 2021,
Ithe Company, entered into a letter agreement (the “Letter Agreement”) with EyePoint
to expand the Dexycu Agreement. During the two-year term of the Letter Agreement, in exchange for EyePoint agreeing to pay the
Company a commission based on all net sales of DEXYCU® in the U.S. the Company assumed full responsibility for the sales and marketing
of DEXYCU and agreed to make offers of employment to eight EyePoint employees, and will be responsible for all sales and marketing related
regulatory compliance. EyePoint retained control over all regulatory approvals and commercial rights for DEXYCU. The Letter Agreement
was made effective as of January 1, 2022 and will continue through December 31, 2023, unless such term is amended by mutual agreement
of the parties or terminated in accordance therewith.
F- 31
The
Letter Agreement also amended the Company’s required minimum sales levels based on the DEXYCU unit demand for the third quarter
of 2021. The failure to achieve these minimum sales levels could result in penalties payable by the Company to EyePoint; provided however,
in no event shall a penalty, if any, exceed commissions payable by EyePoint to the Company.
Upon
expiration or termination of the Letter Agreement, the parties will revert to the terms of the Dexycu Agreement in existence prior to
the effectiveness of the Letter Agreement for the remainder of the original term of the Dexycu Agreement. The Letter Agreement provides
that either party may terminate the Dexycu Agreement upon 30 days’ prior written notice in the event DEXYCU ceases to have Medicare
Part B “pass-through” payment status for a period of not less than 6 months. The Company has an additional right to terminate
the Letter Agreement with 30 days written notice if (i) a proposed or final Hospital Outpatient Prospective Payment System (HOPPS) rule
issued by the Centers for Medicare & Medicaid Services (CMS) during calendar year 2022 does not contain an extension of the pass-through
payment period for DEXYCU beyond December 31, 2022, and (ii) EyePoint has not otherwise waived any minimum sales for a respective quarterly
period.
Subject
to early termination, the Dexycu Agreement expires on August
1, 2025 , subject to specified notice periods
and specified limitations, either party may terminate the Dexycu Agreement in the event
of (i) uncured material breach by the other party or (ii) if DEXYCU ceases to have “pass-through” payment status.
In addition, subject to certain limitations, the Company may terminate the Dexycu Agreement
(i) for convenience subject to an extended specified notice period or (ii) in the event Eyepoint undergoes a change of control. Eyepoint
may terminate the Dexycu Agreement , subject to specified notice periods and specified limitations,
if the Company fails to achieve certain minimum sales levels during specified periods. During the years ended December 31, 2021 and 2020,
the Company recorded $ 3,253
and $ 357 ,
respectively, in commission revenues related to the Dexycu Agreement.
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 upon execution of the Klarity License Agreement, (ii) a second payment
of $ 50 following the first $ 50 in net sales of the Klarity Product; and (iii) a final payment of $ 50 following the first $ 100 in net
sales of the Klarity Product. All of the above referenced milestone payments were payable at the Company’s election in cash or
shares of the Company’s restricted common stock. Dr. Lindstrom was paid $ 165 and $ 149 in cash during the years ended December 31,
2021 and 2020, respectively, and was due an additional $ 30 and $ 35 at December 31, 2021 and 2020, respectively. The Company incurred
$ 160 and $ 129 for royalty expenses related to the Klarity License Agreement during the years ended December 31, 2021 and 2020, 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 upon execution of the Lindstrom APA. Dr. Lindstrom was
paid $ 28 and $ 55 in cash during the year ended December 31, 2021 and 2020, respectively, and was due $ 8 and $ 7 at December 31, 2021 and
2020, respectively. The Company incurred $ 29 and $ 55 for royalty expenses related to the Lindstrom Agreement during the year ended December
31, 2021 and 2020, respectively.
F- 32
Presbyopia
Asset Purchase Agreement – Related Party
In
December 2019, the Company entered into an asset purchase agreement (the “Presbyopia APA”) with Richard L. Lindstrom, M.D.,
a member of its Board of Directors. Pursuant to the terms of the Presbyopia APA, the Company acquired certain intellectual property and
related rights from Dr. Lindstrom to develop, formulate, make, sell, and sub-license an ophthalmic topical product to treat presbyopia
(the “Presbyopia Product”).
Under
the terms of the Presbyopia Product, the Company is required to make royalty payments to Dr. Lindstrom ranging from 2% to 4% of net sales,
dependent upon the final formulation and patent protection of the Presbyopia Product sold . Dr. Lindstrom was paid $ 0 in cash during the
years ended December 31, 2021 and 2020, and was due $ 0 at December 31, 2021 and 2020. The Company incurred $ 0 for royalty expenses related
to the Presbyopia APA during the years ended December 31, 2021 and 2020.
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. SEGMENT INFORMATION AND CONCENTRATIONS
Management
evaluated the Company’s 2021 and 2020 performance based on operating segments. Segment performance for the Company’s two
operating segments are based on segment contribution.
The Company’s reportable segments consisted of (i) its commercial stage pharmaceutical compounding business (Pharmaceutical Compounding),
generally including the operations of ImprimisRx; and (ii) its start-up operations associated with pharmaceutical drug development business
(Pharmaceutical Drug Development). Segment contribution for the segments represents net revenues less cost of sales, R&D expenses,
selling and marketing expenses, and select general and administrative expenses. Management does not evaluate the following items
at the segment level:
● Selling,
general and administrative expenses that result from shared infrastructure, including certain
expenses associated with legal matters, public company costs (e.g. investor relations), board
of directors and principal executive officers and other like shared expenses;
● Operating
expenses within selling, general and administrative expenses that result from the impact
of corporate initiatives. Corporate initiatives primarily include integration, restructuring,
acquisition and other shared costs;
● Other
select revenues and operating expenses including R&D expenses, amortization, and asset
sales and impairments, net as not all such information has been accounted for at the segment
level, or such information has not been used by all segments; and
● Total
assets including capital expenditures.
Management
defines segment net revenues as pharmaceutical compounded
drug sales, 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.
F- 33
Selling,
general and administrative expenses consist mainly of personnel-related costs, marketing and promotion costs, distribution costs, professional
service costs, insurance, depreciation, facilities costs, transaction costs, and professional services costs which are general in nature
and attributable to the segment.
Segment
net revenues, segment operating expenses and segment contribution information consisted of the following for the years ended December
31, 2021 and 2020:
SCHEDULE OF SEGMENT NET REVENUES, SEGMENT OPERATING EXPENSES AND SEGMENT CONTRIBUTION
For
the Year Ended December 31, 2021
Pharmaceutical
Pharmaceutical
Drug
Compounding
Development
Total
Net
revenues
$ 72,476
$ -
$ 72,476
Cost
of sales
( 18,214 )
-
( 18,214 )
Gross
profit
54,262
-
54,262
Operating
expenses:
Selling,
general and administrative
27,465
-
27,465
Research
and development
1,088
8,674
9,762
Segment
contribution
$ 25,709
$ ( 8,674 )
17,035
Corporate
( 13,689 )
Research
and development
( 1,322 )
Amortization
( 161 )
Asset
sales and impairments, net
( 249 )
Operating
income
$ 1,614
For
the Year Ended December 31, 2020
Pharmaceutical
Pharmaceutical
Drug
Compounding
Development
Total
Net
revenues
$ 48,871
$ -
$ 48,871
Cost
of sales
( 14,463 )
-
( 14,463 )
Gross
profit
34,408
-
34,408
Operating
expenses:
Selling,
general and administrative
22,691
144
22,835
Research
and development
759
88
847
Segment
contribution
$ 10,958
$ ( 232 )
10,726
Corporate
( 8,245 )
Research
and development
( 1,566 )
Amortization
( 167 )
Asset
sales and impairments, net
( 363 )
Operating
income
$ 385
The
Company categorizes revenues by geographic area based on selling location. All operations are currently located in the U.S.; therefore,
total revenues are attributed to the U.S. All long-lived assets at December 31, 2021 and December 31, 2020 are located in the U.S.
Beginning in 2022, due to shifts in the Company’s
strategic plans to further focus on growing the Company’s ImprimisRx business and suspension of activities related to starting
up development-stage pharmaceutical companies, along with changes to the Company’s organizational and internal reporting structure,
management will no longer evaluate the Company’s business in two segments and will instead focus 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. These products collectively accounted
for 35 % and 35 % o f
revenues during the years ended December 31, 2021 and 2020, 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, 2021 and 2020 , respectively .
The
Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 74 % of active
pharmaceutical ingredient purchases during the year ended December 31, 2021, and 77 % during the year ended December 31, 2020.
NOTE
20. SUBSEQUENT EVENTS
In
January 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 purposes.
In
February 2022, 50,000 RSUs
granted in February 2019 to Andrew R. Boll, the Company’s Chief Financial Officer, vested, and, 29,395
shares the Company’s common stock were
issued to Mr. Boll, net of 20,605
shares of common stock withheld for payroll tax
withholdings totaling $ 162 .
In
February 2022, 50,000 RSUs
granted in February 2019 to John P. Saharek, the Company’s President of ImprimisRx, vested, and, 24,077
shares the Company’s common stock were
issued to Mr. Saharek, net of 25,923
shares of common stock withheld for payroll tax
withholdings totaling $ 204 .
The
Company has performed an evaluation of events occurring subsequent to December 31, 2021 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- 34