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, 2020, 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, 2020, 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, 2020.
This
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, 2020, 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.
48
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 2021 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 2021 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
2021 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 2021 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 2021 Annual
Meeting of Stockholders.
49
PART
IV
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)
List
of the following documents filed as part of the report:
(1)
See
the index to our consolidated financial statements on page F-1 for a list of the financial statements being filed in this
Annual Report.
(2)
All
financial statement schedules are omitted because they are not applicable or the required information is shown in the consolidated
financial statements or the notes thereto.
(3)
See
Item 15(b) below for all exhibits being filed or incorporated by reference herein.
(b)
Exhibits:
EXHIBIT
INDEX
Exhibit
No.
Description
2.1
Agreement and Plan of Merger, dated as of September 17, 2007, by and among Imprimis Pharmaceuticals, Inc., Transdel Pharmaceuticals Holdings, Inc. and Trans-Pharma Acquisition Corp. Incorporation (incorporated herein by reference to Exhibit 2.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on September 21, 2007)
3.1
Amended and Restated Certificate of Incorporation, as amended by the Certificate of Amendment to Amended and Restated Certificate of Incorporation effective February 28, 2012, as further amended by the Certificate of Amendment to Amended and Restated Certificate of Incorporation effective February 7, 2013, and as further amended by the Certificate of Amendment to Amended and Restated Certificate of Incorporation effective September 10, 2014
3.2
Amended and Restated Bylaws of Imprimis Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 3.2 to the Annual Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on March 28, 2014)
3.3
Certificate of Designation of Series A Convertible Preferred Stock of Imprimis Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on December 20, 2011)
3.4
Amended and Restated Certificate of Incorporation, filed July 2, 2018 (incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on July 2, 2018)
3.5
Amendment to the Restated Certificate of Incorporation for the name change, filed as of December 27, 2018 (incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on December 31, 2018)
4.1*
Description
of the Company’s Securities
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)
50
10.6#
Form of Restricted Stock Unit Agreement (incorporated herein by reference to Exhibit 10.4 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on May 8, 2013)
10.7#
Stand-alone Restricted Stock Unit Agreement, dated July 18, 2012, granted by Imprimis Pharmaceuticals, Inc. to Mark L. Baum (incorporated herein by reference to Exhibit 10.40 to the Company’s Registration Statement on Form S-1 (File No. 333-182846) filed on July 25, 2012)
10.8#
Stand-alone Restricted Stock Unit Agreement, dated July 18, 2012, granted by Imprimis Pharmaceuticals, Inc. to Robert J. Kammer (incorporated herein by reference to Exhibit 10.41 to the Company’s Registration Statement on Form S-1 (File No. 333-182846) filed on July 25, 2012)
10.9
Form of Underwriter’s Warrant (incorporated herein by reference to Exhibit 10.41 to the Company’s Registration Statement on Form S-1 (File No. 333-182846) filed on October 26, 2012)
10.10#
Amended and Restated Employment Agreement, dated May 2, 2013, by and between Imprimis Pharmaceuticals, Inc. and Mark L. Baum (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 May 8, 2013)
10.11#
Performance Stock Units Agreement, dated May 2, 2013, by and between Imprimis Pharmaceuticals, Inc. and Mark L. Baum (incorporated herein by reference to Exhibit 10.4 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on August 14, 2013)
10.12#
Amended and Restated Employment Agreement, effective as of February 1, 2015, by and between Imprimis Pharmaceuticals, Inc. and Andrew R. Boll (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 February 2, 2015)
10.13#
Performance Stock Units Award Agreement, effective as of February 1, 2015, by and between Imprimis Pharmaceuticals, Inc. and Andrew R. Boll (incorporated herein by reference to Exhibit 10.2 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on February 2, 2015)
10.14#
Employment Agreement, effective as of February 1, 2015, by and between Imprimis Pharmaceuticals, Inc. and John P. Saharek (incorporated herein by reference to Exhibit 10.3 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on February 2, 2015)
10.15
Warrant to Purchase Stock, dated May 11, 2015, issued by Imprimis Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.2 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on May 12, 2015)
10.16
Warrant Amendment to Purchase Stock, dated December 27, 2016, issued by Imprimis Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.3 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on December 29, 2016)
10.17
Form of Securities Purchase Agreement, dated March 21, 2017, between the Registrant and the Investors (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on March 22, 2017)
10.18
License Agreement dated April 1, 2017 between Imprimis Pharmaceuticals, Inc. and Richard L. Lindstrom, M.D. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on April 6, 2017)
10.19
Strategic Sales & Marketing Agreement dated April 13, 2017 between Imprimis Pharmaceuticals, Inc. and Cameron Ehlen Group, Inc. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on April 17, 2017)
10.20
Strategic Sales & Marketing Agreement dated April 28, 2017 between Imprimis Pharmaceuticals, Inc. and SightLife Surgical, Inc. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on May 2, 2017)
10.21#
Consulting Agreement dated May 1, 2017 between Eton Pharmaceuticals, Inc. and Mark L. Baum (incorporated herein by reference to Exhibit 10.8 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on August 10, 2017)
10.22#
Consulting Agreement dated May 1, 2017 between Eton Pharmaceuticals, Inc. and Andrew R. Boll (incorporated herein by reference to Exhibit 10.9 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on August 10, 2017)
10.23#
Consulting Agreement dated May 1, 2017 between Eton Pharmaceuticals, Inc. and John P. Saharek (incorporated herein by reference to Exhibit 10.10 to the Quarterly Report on Form 10-Q of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on August 10, 2017)
51
10.24
Asset Purchase and License Agreement (pentoxifylline) dated May 9, 2017 between Imprimis Pharmaceuticals, Inc. and Eton Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on June 20, 2017)
10.25
Asset Purchase and License Agreement (corticotropin) dated May 9, 2017 between Imprimis Pharmaceuticals, Inc. and Eton Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.2 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on June 20, 2017)
10.26
Management Services Agreement dated May 1, 2017 between Imprimis Pharmaceuticals, Inc. and Eton Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 10.4 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on June 20, 2017)
10.27
Loan and Security Agreement, dated July 19, 2017, by and between Imprimis Pharmaceuticals, Inc. and SWK Funding LLC (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 July 20, 2017)
10.28
Imprimis Pharmaceuticals, Inc. 2017 Incentive Stock and Awards Plan (incorporated herein by reference to Exhibit 10.1 to the Registration Statement on Form S-8 of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on August 25, 2017)
10.29
Form of Incentive Stock Option Agreement (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 16, 2017)
10.30
Form of Non-Statutory Stock Option Agreement (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 16, 2017)
10.31
Form of Restricted Stock Award Agreement (incorporated herein by reference to Exhibit 10.3 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc. filed with the Securities and Exchange Commission on June 16, 2017)
10.32
Form of Restricted Stock Unit Agreement (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 16, 2017)
10.33#
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, 2018)
10.34#
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, 2018)
10.35#
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, 2018)
10.36
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)
10.37
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)
10.38
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)
10.39
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)
10.40#
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)
10.41#
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)
52
10.42#
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)
10.43
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)
10.44
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)
10.45
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)
10.46
Joinder and First 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)
10.47#
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)
10.48#
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)
10.49#
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)
10.50
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)
10.51
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)
10.52#
Consulting Agreement dated February 13, 2020 between Stowe Pharmaceuticals, Inc. and Mark L. Baum (incorporated herein by reference to Exhibit 10.64 to the Annual Report on Form 10-K of Harrow Health, Inc. filed with the Securities and Exchange Commission on March 13, 2020)
10.53#
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)
10.54#
Consulting Agreement dated February 13, 2020 between Stowe Pharmaceuticals, Inc. and John P. Saharek (incorporated herein by reference to Exhibit 10.66 to the Annual Report on Form 10-K of Harrow Health, Inc. filed with the Securities and Exchange Commission on March 13, 2020)
10.55
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 10.1 to the Current Report on Form 8-K of Harrow Health, Inc. filed with the Securities and Exchange Commission on April 4, 2020)
10.56
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)
10.57#*
Consulting
Agreement dated July 1, 2020 between Visionology, Inc. and Mark L. Baum
10.58#*
Consulting
Agreement dated July 1, 2020 between Visionology, Inc. and Andrew R. Boll
10.59++
Commercial Alliance Agreement between Eyepoint Pharmaceuticals, Inc. and ImprimisRx, LLC dated August 1, 2020. (incorporated herein by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q of Harrow Health, Inc. filed with the Securities and Exchange Commission on November 9, 2020)
10.60*++
First
Amendment to Commercial Alliance Agreement between Eyepoint Pharmaceuticals, Inc. and
ImprimisRx, LLC dated November 13, 2020.
21.1*
List
of Subsidiaries
53
23.1*
Consent
of Independent Registered Public Accounting Firm
24.1*
Power of Attorney (included on the signature page to this Annual Report)
31.1*
Certification
of Mark L. Baum, Chief Executive Officer, pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities and Exchange Act of 1934,
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification
of Andrew R. Boll, Chief Financial Officer, pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities and Exchange Act of
1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, executed by Mark
L. Baum, Chief Executive Officer.
32.2**
Certification
pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, executed by Andrew
R. Boll, Chief Financial Officer.
101.INS*
XBRL
Instant Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within
the Inline XBRL document.
101.SCH*
Inline
XBRL Taxonomy Extension Schema Document
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*
Inline
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*
Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE*
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
104
The
cover page from the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 has been formatted in
Inline XBRL
#
Management
contract or compensatory plan or arrangement.
*
Filed
herewith.
**
Furnished
herewith.
+
Confidential
treatment has been granted with respect to portions of this exhibit pursuant to Rule 24b-2 of the Exchange Act and these confidential
portions have been redacted from the filing that is incorporated herein by reference. A complete copy of this exhibit, including
the redacted terms, has been separately filed with the Securities and Exchange Commission.
++
Portions
of this exhibit have been omitted in compliance with item 601 of Regulation S-K
ITEM
16. FORM 10-K SUMMARY
None.
54
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
Name:
Mark
L. Baum
Title:
Chief
Executive Officer (Principal Executive Officer)
Date:
March
8, 2021
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 Director
March
8, 2021
Mark
L. Baum
(Principal
Executive Officer)
/s/
Andrew R. Boll
Chief
Financial Officer
March
8, 2021
Andrew
R. Boll
(Principal
Accounting and Financial Officer)
/s/
Robert J. Kammer
Chairman
of the Board of Directors
March
8, 2021
Robert
J. Kammer
/s/
Teresa F. Sparks
Director
March
8, 2021
Teresa
F. Sparks
/s/
Richard L. Lindstrom
Director
March
8, 2021
Richard
L. Lindstrom
/s/
R. Lawrence Van Horn
Director
March
8, 2021
R.
Lawrence Van Horn
55
FINANCIAL
STATEMENTS
Harrow
Health, Inc.
Index
to Consolidated Financial Statements
Report
of Independent Registered Public Accounting Firm
F-2
Consolidated
Balance Sheets at December 31, 2020 and 2019
F-3
Consolidated
Statements of Operations for the years ended December 31, 2020 and 2019
F-4
Consolidated
Statements of Stockholders’ Equity for the years ended December 31, 2020 and 2019
F-5
Consolidated
Statements of Cash Flows for the years ended December 31, 2020 and 2019
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, 2020 and 2019, the related consolidated statements of operations, stockholders’ equity and cash flows
for each of the two years in the period ended December 31, 2020, 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, 2020 and 2019, and the results of its operations and its cash
flows for each of the two years in the period ended December 31, 2020, 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.
Stock-Based
Compensation – Modified Stock Option
Critical
Audit Matter Description
As
described further in Note 14 to the consolidated financial statements, during the year ended December 31, 2020, the Company amended
an employee option to purchase 600,000 shares of the Company’s common stock, which is subject to the satisfaction of certain
market-based vesting criteria, by extending the vesting term and contractual term. Management performed a valuation of the stock
option at the date of modification with the assistance of a third-party valuation specialist, which involved estimation
of the fair value of the modified option. The Company estimated the fair value of the modified stock option using the Monte-Carlo
simulation and Black-Scholes option pricing models.
Auditing
management’s valuation of the modified stock option required auditor judgment and required a high degree of subjectivity
as estimates underlying the determination of fair value were based on various inputs and significant assumptions used in the Monte-Carlo
simulation and Black-Scholes option pricing models, including the probability of triggering the market-based targets, and the
number of shares to be vested.
How
the Critical Audit Matter Was Addressed in the Audit
Our
audit procedures included, among others, reading the relevant Board of Directors minutes and modified stock option agreement for
accuracy and completeness of the modified stock option terms. We involved our valuation specialist to assist in the evaluation
of the Company’s determination of the fair value of the modified stock option, which included testing the appropriateness
of the methodologies and underlying assumptions used, and whether the methods used for determining fair value were applied consistently
with the valuation of similar grants in prior periods. We evaluated the significant assumptions used by management to calculate
the fair value of the modified stock option, which included the expected option term and an independent calculation of the expected
volatility based upon actual historical stock price movements over a period equal to the expected option term. We developed an
independent estimate of the fair value for the modified stock option with the assistance of our valuation specialist and compared
our estimate of fair value to the fair value determined by management.
/s/
KMJ Corbin & Company
LLP
We
have served as the Company’s auditor since 2007.
Irvine,
California
March 8, 2021
F- 2
HARROW
HEALTH, INC.
CONSOLIDATED
BALANCE SHEETS
(In
thousands, except share data)
2020
2019
December
31,
2020
2019
ASSETS
Current assets
Cash
and cash equivalents, including restricted cash of $ 200
$ 4,301
$ 4,949
Investment in Eton
Pharmaceuticals
28,455
25,200
Accounts receivable,
net
2,662
2,009
Inventories
3,962
3,301
Prepaid
expenses and other current assets
751
586
Total current assets
40,131
36,045
Property, plant and equipment, net
4,453
5,375
Operating lease right-of-use assets
6,799
6,559
Intangible assets, net
1,939
2,337
Investment in Surface Ophthalmics
1,314
3,747
Investment in Melt Pharmaceuticals
2,506
4,690
Goodwill
332
332
TOTAL
ASSETS
$ 57,474
$ 59,085
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities
Accounts payable
and accrued expenses
$ 3,932
$ 7,702
Accrued payroll
and related liabilities
2,315
2,117
Deferred
revenue and customer deposits
66
57
Current portion
of paycheck protection program loan payable
1,259
-
Current
portion of loan payable, net of unamortized debt discount
2,639
1,772
Current
portion of operating lease liabilities
580
629
Current
portion of finance lease obligations
8
7
Total current liabilities
10,799
12,284
Operating lease liabilities, net of
current portion
6,652
6,338
Finance lease obligations, net of current
portion
17
26
Accrued expenses, net of current portion
800
800
Paycheck protection program loan payable,
net of current portion
708
-
Loan payable,
net of current portion and unamortized debt discount
11,670
12,219
TOTAL
LIABILITIES
30,646
31,667
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY
Common stock, $ 0.001
par value, 50,000,000
shares authorized, 25,749,875
and 25,526,931
shares issued and outstanding at December 31, 2020
and December 31, 2019, respectively
26
26
Additional paid-in
capital
104,557
101,728
Accumulated
deficit
( 77,400 )
( 74,043 )
TOTAL HARROW HEALTH
STOCKHOLDERS’ EQUITY
27,183
27,711
Noncontrolling
interests
( 355 )
( 293 )
TOTAL
EQUITY
26,828
27,418
TOTAL
LIABILITIES AND EQUITY
$ 57,474
$ 59,085
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)
2020
2019
For
the Years Ended December 31,
2020
2019
Revenues:
Product
sales, net
$ 48,479
$ 51,137
Other
revenues
392
28
Total revenues
48,871
51,165
Cost of sales
( 14,463 )
( 16,749 )
Gross profit
34,408
34,416
Operating expenses:
Selling, general
and administrative
31,247
33,088
Research and development
2,413
2,083
Impairment
of long-lived assets
363
4,040
Total operating
expenses
34,023
39,211
Income (loss)
from operations
385
( 4,795 )
Other income (expense):
Interest expense,
net
( 2,236 )
( 2,500 )
Investment (loss)
gain from Melt Pharmaceuticals, net
( 2,313 )
3,968
Investment loss
from Surface Ophthalmics, net
( 2,433 )
( 1,200 )
Investment gain
from Eton Pharmaceuticals, net
3,255
3,780
Other
(loss) income, net
( 73 )
630
Total other (loss)
income, net
( 3,800 )
4,678
Loss before income tax provision
( 3,415 )
( 117 )
Income
tax provision
4
8
Total net loss including
noncontrolling interests
( 3,419 )
( 125 )
Net
loss attributable to noncontrolling interests
62
293
Net (loss) income
attributable to Harrow Health, Inc.
$ ( 3,357 )
$ 168
Basic net (loss)
income per share of common stock
$ ( 0.13 )
$ 0.01
Diluted net (loss)
income per share of common stock
$ ( 0.13 )
$ 0.01
Weighted average number of common
shares outstanding, basic
25,895,352
25,323,159
Weighted average number of common
shares outstanding, diluted
25,895,352
26,466,098
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, 2020 and 2019
(In
thousands, except for share data)
Shares
Value
Capital
Deficit
Equity
Interest
Equity
Common
Stock
Additional
Total
Harrow Health, Inc.
Total
Noncontrolling
Total
Par
Paid-in
Accumulated
Stockholders’
Equity
Stockholders’
Shares
Value
Capital
Deficit
Equity
Interest
Equity
Balance at January 1, 2019
24,339,610
$ 24
$ 98,938
$ ( 74,211 )
$ 24,751
$ -
$ 24,751
Issuance of common stock in connection
with:
Exercise of warrants
1,142,528
2
811
-
813
-
813
Exercise of employee
options, net of tax withholding
29,793
-
( 44 )
-
( 44 )
-
( 44 )
Issuance of common stock related to vesting of RSUs
-
-
-
-
-
-
-
Stock-based payment
for services provided
15,000
-
234
-
234
-
234
Stock-based compensation expense
-
-
1,789
-
1,789
-
1,789
Net income (loss)
-
-
-
168
168
( 293 )
( 125 )
Balance at December 31, 2019
25,526,931
26
101,728
( 74,043 )
27,711
( 293 )
27,418
Balance at December 31, 2019
25,526,931
$ 26
$ 101,728
$ ( 74,043 )
$ 27,711
$ ( 293 )
$ 27,418
Issuance of common stock in connection
with:
Exercise of employee
options, net of tax withholding
7,159
-
( 29 )
-
( 29 )
-
( 29 )
Issuance of common stock related
to 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
The
accompanying notes are an integral part of these consolidated financial statements
F- 5
HARROW
HEALTH, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(In
thousands)
2020
2019
For
the Years Ended December 31,
2020
2019
CASH FLOWS FROM OPERATING ACTIVITIES
Net
loss (including noncontrolling interests)
$ ( 3,419 )
$ ( 125 )
Adjustments to reconcile
net loss to net cash (used in) provided by operating activities:
Depreciation and
amortization of property, plant and equipment
1,880
1,936
Amortization of
intangible assets
167
209
Amortization of
operating lease right-of-use assets
696
518
Provision for bad
debt expense
213
-
Interest paid-in-kind
on SWK Loan
358
-
Amortization of
debt issuance costs and discount
457
512
Investment gain
from Eton Pharmaceuticals, net
( 3,255 )
( 3,780 )
Investment loss
from Surface Ophthalmics, net
2,433
1,200
Investment loss
(gain) from Melt Pharmaceuticals, net
2,313
( 3,968 )
Loss on disposal
of equipment
105
108
Impairment of long-lived
assets
363
4,040
Stock-based payment
of consulting services
83
234
Stock-based compensation
2,775
1,789
Changes in assets
and liabilities:
Accounts receivable
( 866 )
( 95 )
Inventories
( 661 )
( 2,271 )
Prepaid expenses
and other current assets
( 294 )
( 471 )
Accounts payable
and accrued expenses
( 4,655 )
1,342
Accrued payroll
and related liabilities
198
( 166 )
Deferred
revenue and customer deposits
9
( 62 )
NET CASH (USED
IN) PROVIDED BY OPERATING ACTIVITIES
( 1,100 )
950
CASH FLOWS FROM INVESTING ACTIVITIES
Proceeds on sale
and disposal of assets
13
4
Investment in patent
and trademark assets
( 132 )
( 369 )
Purchases
of property, plant and equipment
( 862 )
( 1,468 )
NET CASH USED
IN INVESTING ACTIVITIES
( 981 )
( 1,833 )
CASH FLOWS FROM FINANCING ACTIVITIES
Payments on finance
lease obligations
( 8 )
( 743 )
Proceeds from SWK
loan
1,000
-
Principal payments
on SWK loan
( 1,497 )
( 750 )
Payments of costs
related to amendment of SWK loan
-
( 282 )
Proceeds from Paycheck
protection program loan payable
1,967
-
Net proceeds from
exercise of warrants and stock options, net of taxes remitted for RSU’s and options
( 29 )
769
NET CASH PROVIDED
BY (USED IN) FINANCING ACTIVITIES
1,433
( 1,006 )
NET CHANGE IN CASH, CASH EQUIVALENTS
AND RESTRICTED CASH
( 648 )
( 1,889 )
CASH,
CASH EQUIVALENTS AND RESTRICTED CASH, beginning of period
4,949
6,838
CASH,
CASH EQUIVALENTS AND RESTRICTED CASH, end of period
$ 4,301
$ 4,949
RECONCILIATION OF CASH, CASH EQUIVALENTS
AND RESTRICTED CASH
Cash and cash equivalents
$ 4,101
$ 4,749
Restricted
cash
200
200
CASH, CASH EQUIVALENTS
AND RESTRICTED CASH AT END OF PERIOD
$ 4,301
$ 4,949
SUPPLEMENTAL DISCLOSURE
OF CASH FLOW INFORMATION:
Cash
paid for income taxes
$ 4
$ 17
Cash
paid for interest
$ 1,791
$ 1,967
SUPPLEMENTAL DISCLOSURES
OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
Purchase of property,
plant and equipment included in accounts payable and accrued expenses
$ 214
$ 39
New
and revaluation of right-of-use assets obtained in exchange for lease obligation
$ 936
$ 753
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 Year Ended December 31, 2020 and 2019
(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”) specializes in the development, production and sale
of innovative medications that offer unique competitive advantages and serve unmet needs in the marketplace through its subsidiaries
and deconsolidated companies. The Company owns one of the nation’s leading ophthalmology-focused pharmaceutical businesses,
ImprimisRx. In addition to wholly owning ImprimisRx, the Company also has equity positions in Eton Pharmaceuticals, Inc. (“Eton”),
Surface Ophthalmics, Inc. (“Surface”), and Melt Pharmaceuticals, Inc. (“Melt”), all companies that began
as subsidiaries of Harrow. In 2020, Harrow created Visionology, Inc. (“Visionology”), which intends to launch an online
eye health platform business. Harrow also owns royalty rights in various drug candidates being developed by Surface and Melt.
The Company intends to continue to create, and hold equity and royalty rights in, new businesses that commercialize drug candidates
that are internally developed or otherwise acquired or licensed from third parties.
During
and subsequent to the year ended December 31, 2020, the Company discontinued 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 to other areas of the Company’s business. The Company
does not expect the suspension of these operations to 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, 79 %
majority controlled, and Stowe, 70 %
majority controlled as of December 31, 2020. The remaining 21 %
of Mayfield is 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 and urological focused drug candidates.
The remaining 30 %
of Stowe was owned by TGV. Stowe was organized to develop ophthalmic drug candidates. The Company controls 100 %
of the equity interests in Visionology. All inter-company accounts and transactions have been eliminated in consolidation.
Harrow
consolidates entities in which we have a controlling financial interest. We
consolidate subsidiaries 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, valuation of investments, realizability of deferred taxes, recoverability of goodwill and long-lived assets,
valuation of contingent acquisition obligations and deferred acquisition obligations, 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 risks and uncertainties as a result of the COVID-19 pandemic. On March 18, 2020, the Centers for Medicare
& Medicaid Services (“CMS”) released guidance for U.S. healthcare providers to limit all elective medical procedures
in order to conserve personal protective equipment and limit exposure to COVID-19 during the pendency of the pandemic. In addition
to limiting elective medical procedures, many hospitals and other healthcare providers have strictly limited access to their facilities
during the pandemic. The COVID-19 pandemic has negatively impacted the global economy, disrupted global supply chains and healthcare
delivery, led to social distancing recommendations, stay-at-home orders and other restrictive measures, and created significant
volatility in financial markets.
F- 7
Many
of the Company’s customers use its drugs in procedures impacted by the CMS guidance to limit elective procedures. In addition,
the Company and our business partners need access to healthcare providers and facilities to conduct clinical trials and other
activities required to achieve regulatory clearance of products under development.
Management
believes reductions in elective procedures in response to CMS guidance have had, and will continue to have, an adverse impact,
which may be material, on the Company’s financial condition, liquidity and results of operations. The severity of the impact
of the COVID-19 pandemic on the Company’s business will depend on a number of factors, including, but not limited to, the
duration and severity of the pandemic and the extent and severity of the impact on its customers, all of which are uncertain and
cannot be predicted. As of the date of the filing of this Annual Report on Form 10-K, the extent to which the COVID-19 pandemic
may materially impact the Company’s financial condition, liquidity or results of operations is uncertain. In addition, the
Company is subject to certain regulatory standards, guidelines and inspections which could impact the Company’s ability
to make, dispense, and sell certain products. If the Company was required to cease compounding and selling certain products as
a result of regulatory guidelines or inspections, this may have a material impact on the Company’s financial condition,
liquidity and results of operations.
Prior
to 2020, the Company had incurred significant operating losses and negative cash flows from operations since its inception. The
Company recorded operating income of $ 385
for the year ended December 31, 2020 and
recorded an operating loss of $ 4,795
for the year ended December 31, 2019.
The Company has an accumulated deficit of $ 77,400
and $ 74,043
as of December 31, 2020 and 2019, respectively.
In addition, the Company used cash in operating activities of $ 1,100
for the year ended December 31, 2020 and
cash provided by operating activities was $ 950
for the year ended December 31, 2019.
While
there is no assurance, management of the Company believes existing cash resources and restricted cash of $ 4,301
at December 31, 2020 together with cash
generated from operations, will be sufficient to sustain the Company’s planned level of operations for at least the next
twelve months. However, estimates of operating expenses and working capital requirements and the future impact of the COVID-19
pandemic on its business could be incorrect. The Company could use its cash resources faster than anticipated. Further, some or
all of the ongoing or planned activities may not be successful and could result in further losses.
The
Company may seek to increase liquidity and capital resources through a variety of means which may include, but are not limited
to: the sale of assets, investments and/or businesses, obtaining financing through the issuance of equity, debt, or convertible
securities; and working to increase revenue growth through sales. There is no guarantee that the Company will be able to obtain
capital when needed on terms management deems acceptable, or at all.
Segments
The
Company’s chief operating decision-maker is its Chief Executive Officer who makes resource allocation decisions and assesses
performance based on financial information presented as operating segments. The Company has identified two
operating segments as reportable segments.
See Note 18 for more information regarding the Company’s reportable segments.
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 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).
F- 8
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
The
Company expenses all costs related to research and development as they are incurred. Research and development 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.
Debt
Issuance Costs and Debt Discount
Debt
issuance costs and the debt discount are recorded net of loans payable and finance lease obligations 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). The Company
began capitalizing certain costs associated with acquiring intellectual property rights during 2015; if costs are not capitalized
they are expensed as incurred.
Income
Taxes
The
Company accounts for income taxes under the provisions of Financial Accounting Standards Board (“FASB”) Accounting
Standards Codification (“ASC”) 740, 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.
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.
F- 9
Investment
in Eton Pharmaceuticals, Inc. – Related Party
The
Company owns 3,500,000
shares of Eton common stock, which represents
approximately 14.4 %
of the equity and voting interests of Eton as of December 31, 2020. At December 31, 2020, the fair market value of Eton’s
common stock was $ 8.13
per share. In accordance with Accounting
Standard Update (“ASU”) 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of
Financial Assets and Financial Liabilities , for the years ended December 31, 2020 and 2019, the Company recorded investment
gains from its Eton common stock position of $ 3,255
and $ 3,780 ,
respectively, related to the change in fair market value of the Company’s investment in Eton during the measurement periods.
As of December 31, 2020 and 2019, the fair market value of the Company’s investment in Eton was $ 28,455
and $ 25,200 ,
respectively.
Mark
Baum, the Company’s Chief Executive Officer, is a member of the board of directors of Eton.
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 $ 98 and
$ 76 as
of December 31, 2020 and 2019, 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.
Investment
in Melt Pharmaceuticals, Inc. – Related Party
In
April 2018, the Company formed Melt as a wholly-owned subsidiary. In January and March of 2019, Melt entered into definitive stock
purchase agreements (collectively, the “Melt Series A Preferred Stock Agreement”) with certain investors and closed
on the sale of Melt’s Series A Preferred Stock (the “Melt Series A Stock”), totaling approximately $ 11,400
of proceeds (collectively, the “Melt
Series A Round”) at a purchase price of $ 5.00
per share. As a result, the Company lost
voting and ownership control of Melt and ceased consolidating Melt’s financial statements.
In
January 2019, the Company deconsolidated Melt and recorded a gain of $ 5,810
and adjusted the carrying value in Melt
to reflect the increased valuation of Melt and the Company’s new ownership interest in accordance with ASC 810-10-40-4(c),
Consolidation .
The
Company owns 3,500,000
common shares of Melt (which is approximately
44 %
of the equity interests as of December 31, 2020) and uses the equity method of accounting for this investment, as management has
determined that the Company has the ability to exercise significant influence over the operating and financial decisions of Melt.
Under this method, the Company recognizes earnings and losses in Melt in its 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. The Company recorded equity in the net gain of
Melt of $ 3,968
during the year ended December 31, 2019.
The Company recorded equity in the net loss of Melt of $ 2,313
during the year ended December 31, 2020.
As of December 31, 2020 and 2019, the Company’s investment in Melt was $ 2,506
and $ 4,690 ,
respectively, which includes $ 851
and $ 722 ,
respectively, due from Melt for reimbursable expenses and amounts due under the Melt Master Services Agreement (“MSA”).
See
Note 4 for more information and related party disclosure regarding Melt.
Investment
in Surface Ophthalmics, Inc. – Related Party
The
Company owns 3,500,000
common shares (which is approximately
30 %
of the equity interests as of December 31, 2020) 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 of Surface. Any intra-entity profits and losses are eliminated. The Company recorded
equity in the net loss of Surface of $ 1,200
during the year ended December 31, 2019.
The Company recorded equity in the net loss of Surface of $ 2,433
during the year ended December 31, 2020.
As of December 31, 2020 and 2019, the carrying value of the Company’s investment in Surface was $ 1,314
and $ 3,747 ,
respectively.
See
Note 5 for more information and related party disclosure regarding Surface.
F- 10
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 software and hardware and
furniture and equipment are depreciated over three
to five years .
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.
Trademarks are an indefinite life intangible asset and are assessed for impairment based on future projected cash flows as further
described below.
The
Company reviews its goodwill and indefinite-lived intangible assets for impairment as of January 1 of each year and when an event
or a change in circumstances indicates the fair value of a reporting unit may be below its carrying amount. Events or changes
in circumstances considered as impairment indicators include but are not limited to the following:
●
significant
underperformance of the Company’s business relative to expected operating results;
●
significant
adverse economic and industry trends;
●
significant
decline in the Company’s market capitalization for an extended period of time relative to net book value; and
●
expectations
that a reporting unit will be sold or otherwise disposed.
The
goodwill impairment test consists of a two-step process as follows:
Step
1. The Company compares the fair value of each reporting unit to its carrying amount, including the existing goodwill. The fair
value of each reporting unit is determined using a discounted cash flow valuation analysis. The carrying amount of each reporting
unit is determined by specifically identifying and allocating the assets and liabilities to each reporting unit based on headcount,
relative revenues or other methods as deemed appropriate by management. If the carrying amount of a reporting unit exceeds its
fair value, an indication exists that the reporting unit’s goodwill may be impaired and the Company then performs the second
step of the impairment test. If the fair value of a reporting unit exceeds its carrying amount, no further analysis is required.
F- 11
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.
Park
Restructuring
In
August 2019, the Company’s subsidiary, Park Compounding, Inc. (“Park”), and Noice Rx, LLC (“Noice”)
terminated an Asset Purchase Agreement dated July 26, 2019 (the “Park Purchase Agreement”), between the parties. Under
the terms of the Park Purchase Agreement, Park had agreed to sell substantially all its assets associated with its non-ophthalmology
pharmaceutical compounding business to Noice, including its pharmacy facility and equipment located in Irvine, California. The
closing of the sale transaction was dependent on the California State Board of Pharmacy approving of the sale and issuing a temporary
pharmacy and sterile license permit to Noice, which did not occur and led to Park ceasing operations at the close of business
on August 27, 2019. As a result, the Company restructured its Park business, ceased operations at its Irvine, California-based
pharmacy, and facilitated the transition of certain compounded formulations and related equipment from Park to the Company’s
New Jersey-based compounded pharmaceutical production facilities (the “Park Restructuring”). As a result of the Park
Restructuring, the Company incurred non-cash impairment costs of approximately $ 3,781
related to assets held at Park, primarily
associated with property, plant, equipment, inventory, goodwill and other intangible assets, and $ 480
in one-time costs related to severance
packages and other costs associated with the Park Restructuring during the year ended December 31, 2019.
The
Company has reduced the Park compounded product formulary to seven base formulations, based on factors including unit order volumes,
revenues and gross margin percentages, and ImprimisRx retained approximately half of Park’s historical revenues during
the first quarter of 2020.
Fair
Value Measurements
Fair
value measurements are determined based on the assumptions that market participants would use in pricing an asset or liability.
GAAP establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes
the use of unobservable inputs by requiring that the most observable inputs be used when available. The established fair value
hierarchy prioritizes the use of inputs used in valuation methodologies into the following three levels:
●
Level
1: Applies to assets or liabilities for which there are quoted prices (unadjusted) for identical assets or liabilities in
active markets. A quoted price in an active market provides the most reliable evidence of fair value and must be used to measure
fair value whenever available.
●
Level
2: Applies to assets or liabilities for which there are significant other observable inputs other than Level 1 prices, such
as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are
observable or can be corroborated by observable market data.
●
Level
3: Applies to assets or liabilities for which there are significant unobservable inputs that reflect a reporting entity’s
own assumptions about the assumptions that market participants would use in pricing an asset or liability. For example, Level
3 inputs would relate to forecasts of future earnings and cash flows used in a discounted future cash flows method.
At
December 31, 2020 and 2019, the Company measured its investment in Eton on a recurring basis. The Company’s investment in
Eton is classified as Level 1 as the fair value is determined using quoted market prices in active markets for the same securities.
As of December 31, 2020 and 2019, the fair market value of the Company’s investment in Eton was $ 28,455
and $ 25,200 ,
respectively.
F- 12
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, loans
payable and operating and finance lease liabilities. The carrying amount of these financial instruments, except for loans payable
and operating and finance lease liabilities, 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. Based on borrowing rates currently available to the Company, the carrying values of the loans payable and operating
and finance lease liabilities approximate their respective fair values.
Stock-Based
Compensation
All
stock-based payments to employees, directors and consultants, including grants of stock options, warrants, restricted stock units
(“RSUs”) and restricted stock, are recognized in the consolidated financial statements based upon their estimated
fair values. The Company uses the Black-Scholes-Merton option pricing model and Monte Carlo simulation model to estimate the fair
value of stock-based awards. The estimated fair value is determined at the date of grant. The financial statement effect of forfeitures
is estimated at the time of grant and revised, if necessary, if the actual effect differs from those estimates.
Basic
and Diluted Net Income (Loss) per Common Share
Basic
net income (loss) per common share is computed by dividing income (loss) attributable to common stockholders for the period by
the weighted average number of common shares outstanding during the period. Diluted income (loss) per share is computed
by dividing the income (loss) 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 income (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 5,411,929
and 4,848,459
at December 31, 2020 and 2019, respectively,
and are excluded in the calculation of diluted net income (loss) 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, 2020 and 2019 was 200,463
and 324,303 ,
respectively.
The
following table shows the computation of basic net income (loss) per share of common stock for the years ended December 31, 2020
and 2019 (in 000’s, except share and per share amounts):
SCHEDULE
OF BASIC EARNINGS PER COMMON SHARE
2020
2019
For
the Year Ended December 31,
2020
2019
Numerator
– net (loss) income attributable to Harrow Health, Inc.
$ ( 3,357 )
$ 168
Denominator – weighted average
number of shares outstanding, basic
25,895,352
25,323,159
Net
(loss) income per share, basic
$ ( 0.13 )
$ 0.01
For
the year end December 31, 2019, the Company computed diluted net income per share using the weighted-average number of common
shares and dilutive common equivalent shares outstanding during that period. Diluted common equivalent shares for the year ended
December 31, 2019 consisted of the following (in 000’s, except share and per share amounts):
SCHEDULE
OF DILUTED COMMON EQUIVALENT SHARES
For
the Year Ended
December
31, 2019
Diluted shares related to:
Warrants
488,498
Stock
options
654,441
Dilutive common
equivalent shares
1,142,939
F- 13
The
following table shows the computation of diluted net income per share using the weighted-average number of common shares and dilutive
common equivalent shares outstanding for the year ended December 31, 2019 (in 000’s, except share and per share amounts):
SCHEDULE
OF DILUTED EARNINGS PER COMMON SHARE
December
31, 2019
For
the Year Ended
December
31, 2019
Numerator
– net income
$ 168
Weighted average number of shares outstanding, basic
25,323,159
Dilutive common
equivalents
1,142,939
Denominator –
number of shares used for diluted earnings per share computation
26,466,098
Net income per
share, diluted
$ 0.01
Recently
Adopted Accounting Pronouncements
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments ,
which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13
replaces the existing incurred loss impairment model with a forward-looking expected credit loss model which will result in earlier
recognition of credit losses. The Company adopted ASU 2016-13 on January 1, 2020, and adoption of the standard did not have a
material effect on the Company’s consolidated financial position, results of operations and cash flows.
In
January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other . This guidance simplifies the accounting for
goodwill impairment for all entities by requiring impairment charges to be based on the first step in the current two-step impairment
test under ASC 350. The updated standard eliminates the requirement to calculate a goodwill impairment charge using Step 2. If
a reporting unit’s carrying amount exceeds its fair value, an entity will record an impairment charge based on that difference.
The impairment charge will be limited to the amount of goodwill allocated to that reporting unit. The Company adopted ASU 2017-04
on January 1, 2020, and adoption of the standard did not have a material effect on the Company’s consolidated financial
position, results of operations and cash flows.
In
August 2018, the FASB issued ASU 2018-13, Changes to Disclosure Requirements for Fair Value Measurements , which improved
the effectiveness of disclosure requirements for recurring and nonrecurring fair value measurements. The standard removes, modifies,
and adds certain disclosure requirements. The Company adopted ASU 2018-13 on January 1, 2020, and adoption of the standard did
not have a material effect on the Company’s consolidated financial position, results of operations and cash flows.
Recently
Issued 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 will be effective for the Company in the first quarter of 2021 on a prospective
basis, and early adoption is permitted. The Company does not expect a material impact of the new guidance on its consolidated
financial statements.
Reclassifications
Certain
prior period items and amounts have been reclassified to conform to the classifications used to prepare the consolidated financial
statements for the year ended December 31, 2020. These reclassifications had no material impact on the Company’s consolidated
financial position, results of operations, or cash flows as previously reported.
NOTE
3. REVENUES
The
Company accounts for contracts with customers in accordance with ASC 606, Revenues from Contracts with Customers. The Company
has three primary streams of revenue: (1) revenue recognized from our sale of products within our pharmacy services (2)
revenue recognized from a commission agreement with a third party and (3) revenue recognized from intellectual property
license and asset purchase agreements.
F- 14
Product
Revenues from Pharmacy Services
The
Company sells prescription drugs directly through our pharmacy and outsourcing facility network. Revenue from our pharmacy services
divisions 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 it generates from a pharmaceutical product that is owned by a third party. The revenue
earned from this arrangement is recognized at the time a customer has ordered the pharmaceutical product and it has shipped from
the third party (or one of its distributors or affiliates), at which point there is no future performance obligation required
by the Company and no consequential continuing involvement on the part of the Company to recognize the associated revenue.
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.
F- 15
Revenue
disaggregated by revenue source for the years ended December 31, 2020 and 2019, consists of the following:
SCHEDULE
OF DISAGGREGATED REVENUE
2020
2019
For
the Years Ended December 31,
2020
2019
Product
sales, net
$ 48,479
$ 51,137
Commissions
356
-
License
36
28
Total
revenues
$ 48,871
$ 51,165
Deferred
revenue and customer deposits at December 31, 2020 and 2019, were $ 66
and $ 57 ,
respectively. All deferred revenue and customer deposit amounts at December 31, 2019 were recognized as revenue during the year
ended December 31, 2020.
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 a Management Services Agreement (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, 2020 and 2019, the Company was due $ 851
and $ 722 ,
respectively, from Melt for reimbursable expenses and amounts due under the Melt MSA. Melt did no t
make any payments to the Company during the year ended December 31, 2020 and paid the Company $ 50
during the year ended December 31, 2019.
The
Company’s Chief Executive Officer, Mark L. Baum, and Chief Medical Officer, Larry Dillaha, are members of the Melt board
of directors, and several employees of the Company (including Mr. Baum, Mr. Dillaha and the Company’s Chief Financial Officer,
Andrew Boll) entered into consulting agreements and provide consulting services to Melt.
The
unaudited condensed results of operations information of Melt is summarized below:
SCHEDULE
OF CONDENSED INCOME STATEMENT
For
the Years Ended December 31,
2020
2019
Revenues, net
$ -
$ -
Loss
from operations
5,019
4,381
Net loss
$ ( 5,019 )
$ ( 4,381 )
The
unaudited condensed balance sheet information of Melt is summarized below:
SCHEDULE
OF CONDENSED BALANCE SHEET
December
31,
2020
2019
Current assets
$ 2,947
$ 7,449
Non current
assets
11
5
Total assets
$ 2,958
$ 7,454
Total liabilities
$ 1,778
$ 1,691
Total preferred
stock and stockholders’ equity
1,180
5,763
Total liabilities
and stockholders’ equity
$ 2,958
$ 7,454
F- 16
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, 2020, the Company owned 3,500,000
shares of Surface common stock (approximately
30 %
of the issued and outstanding equity interests). A Company director, Richard L. Lindstrom, and the Company’s Chief Executive
Officer, Mark L. Baum, are directors of Surface. Surface is required to make royalty payments to Dr. Lindstrom of 3 %
of net sales of certain Surface Products while certain patent rights remain outstanding. Dr. Lindstrom is also a principal of
Flying L Partners, an affiliate of the funding investor who purchased the Surface Series A Preferred Stock. Several employees
and a director of the Company (including Mr. Baum and Dr. Lindstrom) entered into consulting agreements and provided consulting
services to Surface.
The
unaudited condensed results of operations information of Surface is summarized below:
SUMMARY
OF CONDENSED INCOME STATEMENT
For
the Year s Ended December 31,
2020
2019
Revenues, net
$ -
$ -
Loss
from operations
8,109
4,000
Net loss
$ ( 8,109 )
$ ( 4,000 )
The
unaudited condensed balance sheet information of Surface is summarized below:
SUMMARY
OF CONDENSED BALANCE SHEET
December 31,
2020
2019
Current assets
$ 9,074
$ 15,942
Non current
assets
45
47
Total
assets
9,119
15,989
Total liabilities
$ 1,666
$ 619
Total stockholders’
equity
7,453
15,370
Total
liabilities and stockholders’ equity
$ 9,119
$ 15,989
NOTE
6. RESTRICTED CASH
The
restricted cash at December 31, 2020 and 2019 consisted of funds held in a money market account. At December 31, 2020 and 2019,
the restricted cash was recorded at amortized cost, which approximates fair value.
At
December 31, 2020 and 2019, the funds held in a money market account of $ 200
were classified as a current asset. The
money market account funds are required as collateral as additional security for the Company’s New Jersey facility lease.
NOTE
7. INVENTORIES
Inventories
are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, commercial pharmaceutical
products, related laboratory supplies and active pharmaceutical ingredients. The composition of inventories as of December 31,
2020 and 2019 was as follows:
SCHEDULE
OF INVENTORIES
2020
2019
December
31,
2020
2019
Raw materials
$ 2,501
$ 2,405
Work in progress
17
20
Finished goods
1,444
876
Total inventories
$ 3,962
$ 3,301
F- 17
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
2020
2019
December
31,
2020
2019
Prepaid insurance
$ 160
$ 123
Other prepaid expenses
401
358
Deposits and
other current assets
190
105
Total prepaid
expenses and other current assets
$ 751
$ 586
NOTE
9. PROPERTY, PLANT AND EQUIPMENT
Property,
plant and equipment, net at December 31, 2020 and 2019 consisted of the following:
SCHEDULE
OF PROPERTY, PLANT AND EQUIPMENT
2020
2019
December
31,
2020
2019
Property, plant and equipment, net:
Computer
software and hardware
$ 1,707
$ 1,732
Furniture and
equipment
418
363
Lab and pharmacy
equipment
3,426
3,164
Leasehold
improvements
5,720
5,510
Property, plant
and equipment, gross
11,271
10,769
Accumulated
depreciation and amortization
( 6,818 )
( 5,394 )
Property,
plant and equipment, net
$ 4,453
$ 5,375
During
the year ended December 31, 2020, the Company disposed of property, plant and equipment with a net book value of $ 105
related to the discontinued use of certain
computer software and hardware and was included within other (loss) income of the consolidated statements of operations.
The Company recorded depreciation and amortization expense of $ 1,880
and $ 1,936
during the years ended December 31, 2020
and 2019, respectively.
NOTE
10. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at December 31, 2019 consisted of the following:
SCHEDULE
OF INTANGIBLE ASSETS
Amortization
periods
Accumulated
Net
(in
years)
Cost
amortization
Impairment
Carrying
value
Patents
17 - 19
years
$ 1,102
$ ( 97 )
$ ( 259 )
$ 746
Licenses
20
years
50
( 5 )
-
45
Trademarks
Indefinite
340
-
-
340
Customer relationships
3 - 15
years
3,000
( 1,165 )
( 630 )
1,205
Trade name
5
years
16
( 14 )
( 2 )
-
Non-competition clause
3 - 4
years
294
( 274 )
( 20 )
-
State pharmacy
licenses
25
years
45
( 9 )
( 35 )
1
$ 4,847
$ ( 1,564 )
$ ( 946 )
$ 2,337
During
the year ended December 31, 2019, the Company incurred impairment charges of $ 612
related to intangible assets, including
customer relationships, trade name, and state pharmacy licenses as a part of the Park Restructuring and $ 259
of impairment charges related to patents
associated with the termination of an asset agreement.
F- 18
The
Company’s intangible assets at December 31, 2020 consisted of the following:
Amortization
periods
Accumulated
Net
(in
years)
Cost
amortization
Impairment
Carrying
value
Patents
17 - 19
years
$ 929
$ ( 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.
Amortization
expense for intangible assets for the years ended December 31, 2020 and 2019 were as follows:
SCHEDULE
OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
For
the Years Ended
December
31,
2020
2019
Patents
$ 32
$ 48
Licenses
1
5
Customer relationships
134
151
Trade name
-
1
State pharmacy
licenses
-
4
$ 167
$ 209
Estimated
future amortization expense for the Company’s intangible assets at December 31, 2020 is as follows:
SCHEDULE
OF ESTIMATED FUTURE AMORTIZATION EXPENSE
Years
ending December 31,
Dec
2021
187
2022
187
2023
187
2024
160
2025
147
Thereafter
715
Intangible assets
$ 1,583
There
were no
changes in the carrying value of the Company’s
goodwill during the year ended December 31, 2020. Changes in the carrying value of the Company’s goodwill during the year
ended December 31, 2019 were as follows:
SCHEDULE
OF GOODWILL
Dec
Balance at December 31,
2018
$ 2,227
Impairment
of Park goodwill (see Note 2)
( 1,895 )
Balance at
December 31, 2019
$ 332
NOTE
11. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses at December 31, 2020 and 2019 consisted of the following:
SCHEDULE
OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
2020
2019
December
31,
2020
2019
Accounts payable
$ 3,645
$ 7,409
Other accrued expenses
49
49
Accrued interest (see Note 12)
238
244
Accrued exit
fee for note payable (see Note 12)
800
800
Total accounts payable and accrued
expenses
4,732
8,502
Less: Current
portion
( 3,932 )
( 7,702 )
Non-current
total accrued expenses
$ 800
$ 800
F- 19
NOTE
12. DEBT
SWK
Senior Note – 2017
In
July 2017, the Company 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 (“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 are not achieved.
Prior
to the loan refinance in May 2019 (see below), the SWK Loan bore interest at a variable rate equal to the three-month London Inter-Bank
Offered Rate (subject to a minimum of 1.50 %
and maximum of 3.00 %),
plus an applicable margin of 10.50 %.
The SWK Loan Agreement permitted the Company
to pay interest only on the principal amount borrowed thereunder for the first six payments (payments are due on a quarterly basis),
which interest-only period could have been reduced to four payments if the Company had not met certain minimum revenue requirements.
Following the interest-only period, the Company was required to pay interest, plus repayments of the principal amount borrowed
under the SWK Loan Agreement, in quarterly payments, which shall not exceed $ 750
per quarter. All
amounts owed under the SWK Loan Agreement, including an exit fee equal to 5% of the aggregate principal amount loaned thereunder,
were originally due and payable on July 19, 2022. The
Company is obligated under the SWK Loan Agreement to pay for certain expenses incurred by SWK through and after the date of the
SWK Loan Agreement, including certain fees and expenses relating to the preparation and administration of the SWK Loan Agreement.
The Company incurred expenses and an exit fee of approximately $ 1,282
in connection with the SWK Loan Agreement.
The exit fee and expenses were recorded as a debt discount and are being amortized as interest expense over the term of the SWK
Loan using the effective interest rate method and the related liability of $ 800
for the exit fee is included in accrued
expenses (see Note 11) in the accompanying consolidated balance sheets as of December 31, 2020 and 2019.
In
connection with the SWK Loan Agreement, the Company issued to SWK warrants to purchase up to 415,586
shares of the Company’s common stock
(the “Lender Warrants”) with an exercise price of $ 3.08 .
In August 2017, the Company and SWK amended the warrants, to allow for the purchase of up to 615,386
warrants with an exercise price of $ 2.08 .
The Lender Warrants are exercisable immediately, and have a term of seven
years . The Lender Warrants are subject
to a cashless exercise feature, with the exercise price and number of shares issuable upon exercise subject to change in connection
with stock splits, dividends, reclassifications and other conditions. The relative fair value of the Lender Warrants was approximately
$ 982 and
was estimated using the Black-Scholes-Merton option pricing model with the following assumptions: fair value of the Company’s
common stock at issuance of $ 2.08
per share; seven-year contractual term;
113.5 %
volatility; 0 %
dividend rate; and a risk-free interest rate of 1.77 %.
The relative fair value of the Lender Warrants was recorded as a debt discount which is being amortized as interest expense over
the term of the SWK Loan using the effective interest rate method.
SWK
Refinance – May 2019
In
May 2019, the Company entered into a joinder and amendment (the “Amendment”) to the SWK Loan and with SWK, as lender
and collateral agent. A summary of the material changes contained in the Amendment are as follows:
●
The
interest rate calculation that the loan bears is now 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
provides SWK evidence that the Company has achieved a leverage ratio as of such date of less than 4.00:1:00, the Margin Rate
shall equal 9.00%; and if the Company has achieved a leverage ratio as of such date of less than 3.00:1:00, the Margin Rate
shall equal 7.00%;
●
Leverage
ratio in the Amendment 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 twelve (12) month period, adding-back (i) actual
litigation expenses for the immediately preceding twelve (12) month period, minus (ii) actual litigation expenses for the
immediately preceding three (3) month period multiplied by four (4);
●
The
definition of the first amortization date was changed to May 14, 2020, permitting the Company to pay interest only on the
principal amount loaned for the next four payments (payments are due on a quarterly basis) following the Amendment;
●
Subject
to the satisfaction of certain revenue and market capitalization requirements and conditions, SWK agreed to make available
to the Company an additional principal amount of up to $ 5,000 ;
and
●
The
maturity date was changed to July
19, 2023 .
F- 20
Related
to the Amendment, the Company incurred expenses related to legal and lender costs of $ 282
that are included in debt discount and
will be amortized over the remaining term of the SWK Loan.
In
addition to the terms described above, the Amendment joined the Company’s recently created subsidiaries to the SWK Loan
and added definitions related to excluded subsidiaries that are not considered co-borrowers and are subsidiaries of the Company
which the Company believes it will eventually deconsolidate from its financial statements and lose 50 %
or more of the equity interests of the subsidiary.
Second
Amendment to SWK Loan
On
April 1, 2020, the Company and several of its wholly owned subsidiaries entered into a second amendment (the “SWK Second
Amendment”) to the SWK Loan with SWK. A summary of the material changes contained in the SWK Second Amendment are 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.
Interest
expense related to the SWK Loan Agreement, as amended, amounted to $ 1,768
and $ 1,960
for the years ended December 31, 2020
and 2019, respectively, and included amortization of debt issuance costs and discount of $ 457
and $ 512
for the years ended December 31, 2020
and 2019, respectively.
Paycheck
Protection Program Loan
In
April 2020, the Company entered into an unsecured promissory note and related Business Loan Agreement with Renasant Bank, as lender,
for a loan (the “PPP Loan”) in the principal amount of $ 1,967
and received cash proceeds of the same
amount, pursuant to the Paycheck Protection Program (the “PPP”) under the Federal Coronavirus Aid, Relief, and Economic
Security Act (the “CARES Act”), which was enacted March 27, 2020. The PPP is administered by the U.S. Small Business
Administration (the “SBA”).
Under
the terms of the PPP Loan, interest accrues on the outstanding principal at the rate of 1.0 %
per annum. The term of the PPP Loan is two years, unless payment is sooner required in connection with an event of default under
the PPP Loan. To the extent the PPP Loan amount is not forgiven under the PPP, the Company is obligated to make equal monthly
payments of principal and interest, beginning seven months from the date of the PPP Loan, until the maturity date.
The
CARES Act and the PPP provide a mechanism for forgiveness of up to the full amount borrowed. Under the PPP, the Company applied
for forgiveness for all of the PPP Loan during the year ended December 31, 2020, however the SBA has not made a decision related
to the Company’s application for forgiveness. The amount of loan proceeds eligible for forgiveness is based on a formula
that takes into account a number of factors, including the amount of loan proceeds used by the Company during the 24-week period
after the loan origination for certain purposes including payroll costs, interest on certain mortgage obligations, rent payments
on certain leases, and certain qualified utility payments ( it
being anticipated that at least 75% of the loan amount will be required to be used for eligible payroll costs );
the employer maintaining or rehiring employees and maintaining salaries at certain levels; and other factors. Subject to the other
requirements and limitations on loan forgiveness, only loan proceeds spent on payroll and other eligible expenses during the covered
twenty-four-week period will qualify for forgiveness. While the Company has used proceeds from the PPP Loan for such qualifying
expenses, in particular maintaining continuity of its payroll and workforce (including staff critical to the timely production
and dispensing of medicines the Company produces), no assurance can be provided that the Company will obtain forgiveness of the
PPP Loan in whole or in part. No
interest expense was recognized for the
year ended December 31, 2020 related to the PPP Loan.
F- 21
At
December 31, 2020, future minimum payments under the Company’s debt were as follows:
SUMMARY
OF FUTURE MINIMUM PAYMENTS
Amount
2021
$ 5,794
2022
4,700
2023
9,511
Total minimum payments
20,005
Less: amount
representing interest
( 2,927 )
Notes payable, gross
17,078
Less: unamortized
discount
( 802 )
Notes payable
16,276
Less: current
portion, net of unamortized discount
( 3,898 )
Note payable,
net of current portion and unamortized debt discount
$ 12,378
NOTE
13. 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 expires in December
2021 , with
an option
to extend the term for a five-year period ;
●
An
operating lease for 26,400
square feet
of lab, warehouse and office space in Ledgewood, New Jersey, that expires in July
2026 , with
an
option to extend the term for two additional five-year periods .
This includes an amendment that was made effective July 2020 that extended the term of the original lease and added 1,400
of additional
square footage to the lease; and
●
An
operating lease for 5,500
square feet of office space in Nashville,
Tennessee, that expires in December
2024 , with an option
to extend the term for two additional five-year periods .
During
the year ended December 31, 2020, the Company terminated its operating lease for 4,500
square feet of
office and lab space in Irvine, California, that had an expiration date in December 2020. In connection with the termination,
the Company recorded a gain of $ 4
which was recognized
in other income (expense) on the consolidated statements of operations.
At
December 31, 2020 and 2019, 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 11.2
and 10.21
years, respectively.
During
the years ended December 31, 2020 and 2019, cash paid for amounts included for the operating lease liabilities was $ 1,052
and $ 905 ,
respectively, and the Company recorded operating lease expense of $ 1,066
and $ 892 ,
respectively, included in selling, general and administrative expenses.
Future
lease payments under operating leases (including options to extend) as of December 31, 2020 were as follows :
SCHEDULE
OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES
Dec
31, 2020
Operating
Leases
2021
$ 1,017
2022
1,038
2023
1,064
2024
1,090
2025
916
Thereafter
5,141
Total minimum lease payments
10,266
Less: amount
representing interest payments
( 3,034 )
Total operating
lease liabilities
7,232
Less: current
portion, operating lease liabilities
( 580 )
Operating
lease liabilities, net of current portion
$ 6,652
The
Company also has a finance lease for equipment which requires monthly payments of $ 1
through January 2024.
F- 22
Future
lease payments under the finance lease as of December 31, 2020 were as follows :
SCHEDULE
OF FUTURE LEASE PAYMENT UNDER FINANCE LEASE
Dec
31, 2020
Finance
Lease
2021
$ 9
2022
9
2023
9
2024
1
Total minimum lease payments
28
Less: amount
representing interest payments
( 3 )
Present value of future minimum lease
payments
25
Less: current
portion, finance lease obligation
( 8 )
Finance lease
obligation, net of current portion
$ 17
At
December 31, 2020 and 2019, 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 3.08
and 4.08
years, respectively.
For
the years ended December 31, 2020 and 2019:
●
debt
discount amortization related to a finance lease obligation was $ 0
and $ 17 ,
respectively;
●
amortization
expense related to the equipment held under the finance lease obligations was $ 8
and $ 150 ,
respectively; and
●
cash
paid and expense recognized for interest expense related to the finance lease obligation was $ 2
and $ 18 ,
respectively.
NOTE
14. STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
Common
Stock
At
December 31, 2020 and 2019, the Company had 50,000,000 shares of common stock, $ 0.001 par value, authorized, respectively.
Issuances
During the Year Ended December 31, 2019
During
the year ended December 31, 2019:
●
the
Company issued 15,000 shares of its restricted common stock, with a fair value of $ 75 , as consideration for commission expenses
incurred during the year ended December 31, 2018;
●
the
Company issued 27,671 shares of its common stock upon the cashless exercise of options to purchase 82,929 shares of common
stock, with exercise prices ranging from $ 1.70 to $ 4.17 per share, net of 8,806 shares of common stock withheld for payroll
tax withholdings totaling $ 50 ;
●
the
Company issued 2,122 shares of its common stock upon the exercise of options to purchase 2,122 shares of common stock, with
exercise prices ranging from $ 1.70 to $ 3.20 per share, and received net proceeds of $ 6 ;
●
the
Company issued 688,473 shares of its common stock upon the cashless exercise of warrants to purchase 964,532 shares of common
stock with an exercise price of $ 1.79 per share;
●
the
Company issued 454,055 shares of its common stock upon the exercise of warrants to purchase 454,055 shares of common stock
with an exercise price of $ 1.79 per share, and received net proceeds of $ 813 ; and
●
the
Company issued 87,610 shares of its
common stock underlying RSUs issued to directors vested, but the issuance and delivery of these shares are deferred until
the director resigns.
F- 23
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.
Preferred
Stock
At
December 31, 2020 and 2019, the Company had 5,000,000 shares of preferred stock, $ 0.001 par value, authorized and no shares of
preferred stock issued and outstanding.
Stock
Option Plan
On
September 17, 2007, the Company’s Board of Directors and stockholders adopted the Company’s 2007 Incentive Stock and
Awards Plan, which was subsequently amended on November 5, 2008, February 26, 2012, July 18, 2012, May 2, 2013 and September 27,
2013 (as amended, the “2007 Plan”). The 2007 Plan reached its term in September 2017, and we can no longer issue additional
awards under this plan, however, options previously issued under the 2007 Plan will remain outstanding until they are exercised,
reach their maturity or are otherwise cancelled/forfeited. On June 13, 2017, the Company’s Board of Directors and stockholders
adopted the Company’s 2017 Incentive Stock and Awards Plan (the “2017 Plan” together with the 2007 Plan, the
“Plans”). As of December 31, 2020, the 2017 Plan provides for the issuance of a maximum of 2,000,000 shares of the
Company’s common stock. The purpose of the Plans are to attract and retain directors, officers, consultants, advisors and
employees whose services are considered valuable, to encourage a sense of proprietorship and to stimulate an active interest of
such persons in the Company’s development and financial success. Under the Plans, the Company is authorized to issue incentive
stock options intended to qualify under Section 422 of the Internal Revenue Code, non-qualified stock options, restricted stock
units and restricted stock. The Plans are administered by the Compensation Committee of the Company’s Board of Directors.
The Company had 342,882 shares available for future issuances under the 2017 Plan at December 31, 2020.
Stock
Options
A
summary of stock option activity under the Plan for the year ended December 31, 2020 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, 2020
2,656,683
$ 5.31
Options granted
414,500
$ 6.44
Options exercised
( 19,748 )
$ 3.19
Options cancelled/forfeited
( 21,402 )
$ 12.77
Options outstanding
- December 31, 2020
3,030,033
$ 5.43
5.72
$ 5,569
Options exercisable
1,908,849
$ 4.49
5.25
$ 5,051
Options vested
and expected to vest
2,918,298
$ 5.37
5.69
$ 5,519
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, 2020, based on the closing price of the Company’s common stock of $ 6.86
on that date.
The
intrinsic value of the options exercised in 2020 was $ 50 .
F- 24
During
the year ended December 31, 2020, 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, 2020 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 to purchase 600,000 shares of the Company’s
common stock (the “Baum Performance Option”) 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.
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
2020
2019
Weighted-average fair
value of options granted
$ 3.86
$ 3.72
Expected terms (in years)
0.50
- 6.11
5.07
- 7.00
Expected volatility
67
– 71 %
64
- 78 %
Risk-free interest rate
0.34
– 1.64 %
1.83
– 2.68 %
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
770,440
5.64
$ 2.06
745,255
$ 2.06
$ 3.04 - $ 4.50
517,002
5.75
$ 3.98
438,873
$ 3.98
$ 5.49 - $ 6.36
496,350
7.22
$ 6.10
291,919
$ 6.13
$ 6.64 - $ 8.99
1,246,241
5.17
$ 7.85
432,802
$ 8.09
$ 1.47 - $ 8.99
3,030,033
5.72
$ 5.43
1,908,849
$ 4.49
As
of December 31, 2020, there was approximately $ 2,794 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 3.96 years.
The stock-based compensation for all stock options was $ 1,579 and $ 889 during the years ended December 31, 2020 and 2019, respectively.
Restricted
Stock Units
RSU
awards are granted subject to certain vesting requirements and other restrictions, including performance and market-based
vesting criteria. The grant-date fair value of the RSUs, which has been determined based upon the market value of the Company’s
common stock on the grant date, is expensed over the vesting period of the RSUs.
F- 25
Grants
During the Year Ended December 31, 2019
During
the year ended December 31, 2019, 185,000 RSUs with a fair market value of $ 1,139 were issued to certain employees; the RSUs vest
in full on the third anniversary of the grant date.
During
the year ended December 31, 2019, the Company’s board of directors were granted 38,860 RSUs with a fair market value of
$ 300 which vests 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, 2019 is as follows:
SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY
Number
of RSUs
Weighted
Average Grant
Date Fair Value
RSUs unvested - January
1, 2019
1,275,680
$ 2.16
RSUs granted
223,860
$ 6.43
RSUs vested
( 87,610 )
$ 3.42
RSUs cancelled/forfeited
-
RSUs unvested
at December 31, 2019
1,411,930
$ 2.76
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
As
of December 31, 2020, the total unrecognized compensation expense related to unvested RSUs was approximately $ 1,363 which is expected
to be recognized over a weighted-average period of 3.14 years, based on estimated vesting schedules. The stock-based compensation
for RSUs was $ 1,167 and $ 879 during the years ended December 31, 2020 and 2019, respectively.
Subsidiary
Stock-Based Transactions
Mayfield
Pharmaceuticals, Inc. - 2019
During
the year ended December 31, 2019:
●
Mayfield
issued 1,000,000 shares of its common stock to Elle in connection with the acquisition of certain drug candidate intellectual
property and rights in February 2019;
●
Mayfield
issued 300,000 shares of its common stock to TGV in connection with the acquisition of certain drug candidate intellectual
property and rights in July 2019; and
●
the
Company recognized $ 26 in stock-based compensation related to equity instruments granted by Mayfield for 2,450,000 shares
of its restricted common stock that vest upon various performance based milestones and service periods to consultants of Mayfield,
including Mayfield’s CEO candidate and to Harrow employees, including 725,000 shares to Mark Baum, CEO of the Company,
and 362,500 shares to Andrew Boll, CFO of the Company.
F- 26
Mayfield
Pharmaceuticals, Inc. - 2020
During
the year ended December 31, 2020:
●
Mayfield
repurchased 650,000 shares of its common stock from Elle, for an aggregate purchase price of $ 1 ;
●
500,000
shares of Mayfield’s restricted common stock were forfeited by a consultant; and
●
Mayfield
issued 475,000 shares of its restricted common stock, with a fair value of $ 11 , that vest upon various performance-based milestones
and over a four-year service period to Mayfield’s Chief Executive Officer candidate.
During
the year ended December 31, 2020, the Company recognized $ 20 in stock-based compensation for Mayfield stock options.
Stowe
Pharmaceuticals, Inc. - 2019
In
July 2019, Stowe agreed to issue 1,750,000 shares of its common stock to TGV in connection with the acquisition of certain drug
candidate intellectual property and rights.
Visionology,
Inc. - 2020
During
the year ended December 31, 2020, Visionology granted 2,000,000 shares of its restricted common stock, with a fair value of $ 96
that vest upon various performance based milestones and service periods to consultants of Visionology, including Visionology’s
CEO candidate and to Harrow employees, including 700,000 shares to Mark Baum, CEO of the Company, and 350,000 shares to Andrew
Boll, CFO of the Company.
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 Years Ended December 31,
2020
2019
Employees – selling,
general and administrative
$ 2,289
$ 1,464
Directors – selling, general
and administrative
473
300
Consultants
– selling, general and administrative
96
259
Total
$ 2,858
$ 2,023
Warrants
From
time to time, the Company issues warrants to purchase shares of the Company’s common stock to investors, lenders (see Note
12), underwriters and other non-employees for services rendered or to be rendered in the future.
A
summary of warrant activity during the year ended December 31, 2020 is as follows:
SCHEDULE OF WARRANTS ACTIVITY
Number
of Shares Subject to Warrants Outstanding
Weighted
Avg. Exercise Price
Warrants outstanding
- January 1, 2020
780,386
$ 2.12
Granted
-
Exercised
-
-
Expired
-
-
Warrants outstanding
and exercisable - December 31, 2020
780,386
$ 2.12
Weighted average
remaining contractual life of the outstanding warrants in years - December 31, 2020
3.53
All
warrants outstanding as of December 31, 2020 are included in the following table:
SCHEDULE OF WARRANTS OUTSTANDING AND WARRANTS EXERCISABLE
Warrants
Outstanding
Warrants
Exercisable
Warrants
Exercise
Warrants
Expiration
Warrant
Series
Issue
Date
Outstanding
Price
Exercisable
Date
Lender warrants
5/11/2015
125,000
$ 1.79
125,000
5/11/2025
Settlement warrants
8/16/2016
40,000
$ 3.75
40,000
8/16/2021
Lender warrants
(see Note 12)
7/19/2017
615,386
$ 2.08
615,386
7/19/2024
780,386
$ 2.12
780,386
F- 27
NOTE
15. INCOME TAXES
The
Company is subject to taxation in the United States, California, Florida, Georgia, Illinois, New Jersey, New York, Tennessee and
Wisconsin. The Company’s income tax provision consists of the following:
SCHEDULE OF PROVISION FOR INCOME TAXES
December
31,
2020
2019
Current:
Federal
$ -
$ -
State
4
8
Total current
expense
4
8
Deferred:
Federal
( 771 )
669
State
138
( 148 )
Change
in valuation allowance
633
( 521 )
Total deferred
expense
-
-
Income tax provision
$ 4
$ 8
A
reconciliation of income taxes computed by applying the statutory U.S. income tax rate to the Company’s loss before income
tax provision to the income tax provision is as follows:
SCHEDULE OF INCOME TAX RECONCILIATION
December
31,
2020
2019
U.S. federal statutory tax
rate
21.00 %
21.00 %
State tax benefit, net
( 0.11 )%
( 6.73 )%
Stock-based
compensation
5.52 %
3.10 %
Other
( 0.38 )%
( 358.67 )%
Valuation allowance
( 26.14 )%
334.57 %
Effective income
tax rate
( 0.11 )%
( 6.73 )%
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
2020
2019
December
31,
2020
2019
Deferred tax assets (liabilities):
NOL’s
$ 19,685
$ 19,827
Depreciation and
amortization
528
224
Other
413
641
Research and development
credits
596
596
Deferred stock-based
compensation
4,024
3,533
Basis difference
in Melt
( 398 )
( 1,119 )
Basis difference
in Surface
( 502 )
( 1,185 )
Basis difference
in Eton
( 8,626 )
( 7,528 )
Capital losses
63
63
Park stock purchase
identifiable intangibles
( 274 )
( 270 )
Limitation under
163(j)
195
299
ASC 842 lease
liability
2,192
2,082
ASC
842 ROU asset
( 2,061 )
( 1,959 )
Total
deferred tax assets, net
15,835
15,202
Valuation
allowance
( 15,835 )
( 15,202 )
Net
deferred tax assets
$ -
$ -
F- 28
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 $ 633 and
decreased by $ 521 during 2020 and 2019, respectively.
At
December 31, 2020, the Company has federal and state net operating loss carryforwards of approximately $ 62,856 and $ 60,908 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 carryforwards of $3,865 generated after 2017 that can be carried over indefinitely and
may be used to offset up to 80% of federal taxable income. At December 31, 2020, the Company has federal and state research
and development tax credits of approximately $ 354 and $ 305 , respectively. The federal research tax credit begins to expire in
2026 , unless previously utilized, and the state research and development tax credit has no expiration date.
Utilization
of the net operating loss (“NOL”) and research and development (“R&D”) carryforwards maybe 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 carryforwards 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.
The
Company has not completed a study to assess whether an ownership change or changes have occurred. If the Company has experienced
an ownership change, utilization of the NOL or R&D credit carryforwards would be subject to an annual limitation under Section 382
of the Code, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change
by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation
may result in expiration of a portion of the NOL or R&D credit carryforwards before utilization. Further, until a study is
complete and any limitation is known, no amounts are being considered as an uncertain tax position or disclosed as an unrecognized
tax benefit. Any carryforwards that will expire prior to utilization as a result of such limitations will be removed from deferred
tax assets with a corresponding reduction of the valuation allowance.
As
of December 31, 2020 and 2019, 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, 2020 and 2019, and has not recognized interest and/or penalties in the consolidated statements of operations for
the years ended December 31, 2020 and 2019. 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.
F- 29
NOTE
16. 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 $ 272 and $ 312 to the plan during the
years ended December 31, 2020 and 2019, respectively.
NOTE
17. COMMITMENTS AND CONTINGENCIES
Legal
Dr.
Sobol
In
December 2016, Louis L. Sobol, M.D. (“Sobol”) filed a lawsuit in the U.S. District Court for the Eastern District
of Michigan, Southern Division against the Company, asserting claims on behalf of himself and an as-yet-uncertified class of consumers.
The claims allege violations under the Telephone Consumer Protection Act, 47 U.S.C. § 227 via the Company’s alleged
transmittal of advertisements to its clients via facsimile. The Court approved the parties’ proposed settlement agreement
in the spring of 2019. During the year ended December 31, 2018, the Company accrued $ 640 for expected damages related to this
matter and the proposed settlement amount. As a result of the low claim rate of approximately 1.4 % , the Company’s total
damages were $ 571 , which was paid in October 2019. This formally resolved all known disputes between the parties.
Allergan
USA
In
September 2017, Allergan USA, Inc. (“Allergan”) filed a lawsuit in the U.S. District Court for the Central District
of California against the Company, primarily claiming violations under the federal Lanham Act and California’s Sherman Act.
The Court granted in part and denied in part each parties’ motions for summary judgement, resolving all issues except for
whether Allergan was entitled to damages related to the Company’s purported Lanham Act violations. The parties went to trial
in May 2019 to litigate damages related to the Lanham Act, and a jury found the Company liable for only $ 49 in lost profit damages,
which was accrued as an expense during the year ended December 31, 2019 (see Note 11). In July 2019, the Court entered a permanent
injunction, the scope of which is limited to compounded drugs prepared in, dispensed from within, or shipped to the state of California.
The injunction requires the Company to: (1) only dispense drugs from a 503(a) facility with a “Valid Prescription Order”;
(2) abide by the FDA’s anticipatory compounding guidelines; and (3) only use bulk drug substances identified on a list established
by the Secretary of Health and Human Services or FDA’s interim “Category 1” list. The Company believes it was
already in compliance with the order, prior to the injunction being ordered. On October 2, 2019, Allergan and the Company filed
a joint stipulation to voluntarily dismiss each parties’ respective pending appeals arising out of the lawsuit. No economic
consideration was exchanged between the parties related to the filing of the joint stipulation. This formally resolved all known
disputes between the parties.
California
Board of Pharmacy
In
March 2018, the California Board of Pharmacy filed an accusation against Park related to a compounded formulation the Company
believes was legally dispensed and was, without its knowledge, inappropriately administered to a patient unknown to Park, by the
prescribing healthcare professional. Park filed a response to the accusation and requested a formal hearing. In April 2019, Park
agreed to, and the California State Board of Pharmacy approved terms of a settlement agreement (the “Settlement Agreement”)
that became effective on May 29, 2019. Pursuant to the terms of the Settlement Agreement, Park was required to, and did, surrender
its California pharmacy license by August 27, 2019. This formally resolved all known disputes between the parties.
Novel
Drug Solutions et al.
In
April 2018, Novel Drug Solutions, LLC and Eyecare Northwest, PA (collectively “NDS”) filed a lawsuit against the Company
in the U.S. District Court of Delaware asserting claims for breach of contract. The claims stem from an asset purchase agreement
between the Company and NDS entered into in 2013. In July 2019, NDS filed a second amended complaint which added a claim related
to its purported termination of the APA. In October 2019, NDS voluntarily dismissed all claims related to breach of contract,
leaving only claims related to the scope of the post-termination obligations to be litigated. On October 29, 2020, at a hearing
on the various dispositive motions before it, the Court found that there were triable issues of fact and reopened discovery for
limited purposes. NDS is seeking unspecified damages, interest, attorney’s fees and other costs. The Company believes the
claims are meritless and has previously and will continue to dispute all claims asserted against it and intends to vigorously
defend against these allegations. Nonetheless, the Company cannot predict the eventual outcome of this litigation and it could
result in substantial costs, losses and a diversion of management’s resources and attention, which could harm the Company’s
business and the value of its common stock.
F- 30
Product
and Professional Liability
Product
and professional liability litigation represents an inherent risk to all firms in the pharmaceutical and pharmacy industry. We
utilize traditional third-party insurance policies with regard to our product and professional liability claims. Such insurance
coverage at any given time reflects current market conditions, including cost and availability, when the policy is written.
John
Erick et al.
In
January 2018, John Erick and Deborah Ferrell, successors-in-interest and heirs of Jade Erick, (collectively “Erick”)
filed a lawsuit in the San Diego County Superior against Kim Kelly, ND, MPH asserting claims related to the death of Jade Erick.
In April 2018, Erick filed an amendment to the lawsuit, naming 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
seeks indemnity and contribution from the Company and Spectrum. The Company answered the claims filed by Dr. Kelly in October
2018. The case is currently in the discovery phase. Erick is seeking unspecified damages, interest, attorney’s fees and
other costs. The Company believes the claims are meritless and has previously and will continue to dispute all claims asserted
against it and intends to vigorously defend against these allegations. Nonetheless, the Company cannot predict the eventual outcome
of this litigation, it could result in substantial costs, losses and a diversion of management’s resources and attention,
which could harm the Company’s business and the value of its common stock.
Anna
Sue Gaukel et al.
In
June 2019, Anna Sue Gaukel and Lawrence Gaukel served the Company with a lawsuit filed in state court in Idaho against Imprimis
Pharmaceuticals, Inc. asserting class action allegations and product liability claims related to Mrs. Gaukel’s doctor’s
use of a compounded drug injection in each of her eyes. In June 2019, the Company removed the case to Federal Court and subsequently
answered the complaint. On January 24, 2019, the plaintiffs and the Company filed a joint stipulation, and the case was dismissed
with prejudice. No economic consideration was exchanged between the parties related to the filing of the joint stipulation. This
formally resolved all known disputes between the parties as connected to 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 $ 83 and $ 159 related to stock-based payments for these agreements during the year ended December
31, 2020 and 2019, respectively, and $ 2,434 and $ 2,700 were incurred under these agreements for commission expenses during the
years ended December 31, 2020 and 2019, respectively.
F- 31
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 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. $ 224 and $ 371 were accrued in accounts payable and accrued expenses under these agreements
during the years ended December 31, 2020 and 2019, respectively, and $ 682 and $ 846 were incurred under these agreements as royalty
expenses for the years ended December 31, 2020 and 2019, respectively.
Mayfield
License
In
July 2020, Mayfield entered into a License Agreement (the “TGV License”) with TGV to acquire intellectual property
rights for use in the women’s health field, related to Mayfield’s proprietary drug candidate MAY-66. The TGV License
provides that TGV will cooperate with Mayfield in transferring all embodiments of the intellectual property (including know-how)
related to the TGV License, assist in obtaining and protecting its patent rights for the acquired intellectual property and that
Mayfield will use commercially reasonable efforts to research, develop and commercialize products based on the acquired intellectual
property. In connection with the TGV License, Mayfield is obligated to make royalty payments to TGV equal to a low single digit
percentage of net sales received by Mayfield in connection with the sale or licensing of any product based on the licensed intellectual
property. In addition, Mayfield issued 300,000 shares of its common stock to TGV and is required to make certain milestone payments
to TGV over the development of MAY-66 and any related products based on the licensed intellectual property.
Stowe
License
In
July 2020, Stowe entered into a License Agreement (the “Stowe License”) with TGV, to acquire intellectual property
rights for use in the ophthalmology and otic health field, related to Stowe’s proprietary drug candidate STE-006. The Stowe
License provides that TGV will cooperate with Stowe in transferring all embodiments of the intellectual property (including know-how)
related to the Stowe License, assist in obtaining and protecting its patent rights for the acquired intellectual property and
that Stowe will use commercially reasonable efforts to research, develop and commercialize products based on the acquired intellectual
property. In connection with the Stowe License, Stowe is obligated to make royalty payments to TGV equal to a low single digit
percentage of net sales received by Stowe in connection with the sale or licensing of any product based on the licensed intellectual
property. In addition, Stowe issued 1,750,000 shares of its common stock to TGV and is required to make certain milestone payments
to TGV over the development of STE-006 and any related products based on the licensed intellectual property.
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 $ 149
and $ 63
in cash during the years ended December
31, 2020 and 2019, respectively, and was due an additional $ 35
and $ 55
at December 31, 2020 and 2019, respectively.
The Company incurred $ 129
and $ 103
for royalty expenses related to the Klarity
License Agreement during the years ended December 31, 2020 and 2019, respectively.
F- 32
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, t he 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 $ 55 and $ 0 in cash during the years ended December 31, 2020 and 2019, respectively, and was due $ 7 and
$ 40 at December 31, 2020 and 2019, respectively. The Company incurred $ 55 and $ 40 for royalty expenses related to the Lindstrom
APA during the years ended December 31, 2020 and 2019, respectively.
Presbyopia
Asset Purchase Agreement – Related Party
In
December 2019, the Company entered into an asset purchase agreement (the “Presbyopia APA”) with Richard L. Lindstrom,
M.D., a member of its Board of Directors. Pursuant to the terms of the Presbyopia APA, the Company acquired certain intellectual
property and related rights from Dr. Lindstrom to develop, formulate, make, sell, and sub-license an ophthalmic topical product
to treat presbyopia (the “Presbyopia Product”).
Under
the terms of the Presbyopia APA, 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, 2020 and 2019, and was due $ 0 at December 31, 2020 and 2019. The Company incurred $ 0
for royalty expenses related to the Presbyopia APA during the years ended December 31, 2020 and 2019.
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 DEXCYU 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 DEXCYU in the U.S.
Subject
to early termination, the Dexycu Agreement expires on August 1, 2025, subject to
specified notice periods and specified limitations, either party may terminate the Dexycu
Agreement in the event of (i) uncured material breach by the other party or (ii) if DEXCYU 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 year ended December 31, 2020, the Company recorded $ 357 in commission revenues related to the Dexycu Agreement.
NOTE
18. SEGMENT INFORMATION AND CONCENTRATIONS
Beginning
on January 1, 2019, the Company began evaluating performance of the Company based on operating segments. Segment performance for
its two operating segments are based on segment contribution. The Company’s reportable segments consist of (i) its commercial
stage pharmaceutical compounding business (Pharmaceutical Compounding), generally including the operations of ImprimisRx and the
former Park businesses; and (ii) its start-up operations associated with pharmaceutical drug development business (Pharmaceutical
Drug Development). Segment contribution for the segments represents net revenues less cost of sales, research and development,
selling and marketing expenses, and select general and administrative expenses. The Company does not evaluate the following items
at the segment level:
●
Selling,
general and administrative expenses that result from shared infrastructure, including certain expenses associated with legal
matters, public company costs (e.g. investor relations), board of directors and principal executive officers and other like
shared expenses;
F- 33
●
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.
The
Company defines segment net revenues as pharmaceutical compounded drug sales, licenses and other revenue derived from related
agreements.
Cost
of sales within segment contribution includes direct and indirect costs to manufacture formulations and sell products, including
active pharmaceutical ingredients, personnel costs, packaging, storage, royalties, shipping and handling costs, manufacturing
equipment and tenant improvements depreciation, the write-off of obsolete inventory and other related expenses.
Selling,
general and administrative expenses consist mainly of personnel-related costs, marketing and promotion costs, distribution costs,
professional service costs, insurance, depreciation, facilities costs, transaction costs, and professional services costs which
are general in nature and attributable to the segment.
Segment
net revenues, segment operating expenses and segment contribution information consisted of the following for the years ended December
31, 2020 and 2019:
SCHEDULE OF SEGMENT NET REVENUES, SEGMENT OPERATING EXPENSES AND SEGMENT CONTRIBUTION
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
For
the Year Ended December 31, 2019
Pharmaceutical
Pharmaceutical
Drug
Compounding
Development
Total
Net revenues
$ 51,165
$ -
$ 51,165
Cost of sales
( 16,749 )
-
( 16,749 )
Gross profit
34,416
-
34,416
Operating expenses:
Selling, general
and administrative
24,460
174
24,634
Research and development
1,006
361
1,367
Segment
contribution
$ 8,934
$ ( 535 )
8,399
Corporate
( 8,245 )
Research and development
( 716 )
Amortization
( 209 )
Asset sales and
impairments, net
( 4,040 )
Operating
loss
$ ( 4,795 )
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, 2020 and December 31, 2019 are located in the
U.S.
F- 34
Concentrations
The
Company sells its compounded formulations to a large number of customers. There were no customers who comprised more than 10 %
of the Company’s total pharmacy sales for the years ended December 31, 2020 and 2019.
The
Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 77 %
of active pharmaceutical ingredient purchases during the year ended December 31, 2020, and 73 % during the year ended December
31, 2019.
NOTE
19. SUBSEQUENT EVENTS
In
March 2021, the Company issued 10,989
shares of its common stock upon the exercise
of options to purchase 10,989
shares of
common stock, with exercise prices ranging between $ 1.70
to $ 3.96
per share, and received net proceeds of
$ 27 .
Restricted
stock units granted in February 2015 to Andrew R. Boll, the Company’s Chief Financial Officer, vested, and in February 2021,
22,500 shares the Company’s common stock were issued to Mr. Boll, net of 7,500 shares of common stock withheld for payroll
tax withholdings totaling $ 58 .
Restricted
stock units granted in February 2015 to Mark L. Baum, the Company’s Chief Executive Officer, vested, and in February 2021,
200,000 shares the Company’s common stock were issued to Mr. Baum.
The
Company has performed an evaluation of events occurring subsequent to December 31, 2020 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- 35