78 unchanged sentences
Item 15(b) below for all exhibits being filed or incorporated by reference herein.
−Removed: INDEX to be UPDATED BY HARROW
Agreement and Plan of Merger, dated as of September 17, 2007, by and among Imprimis Pharmaceuticals, Inc., Transdel Pharmaceuticals Holdings, Inc.
13 unchanged sentences
filed with the Securities and Exchange Commission on December 31, 2018)
−Removed: Certificate of Designation designating the Series B Cumulative Preferred Stock of the Company (incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of the Company filed with the Securities and Exchange Commission on May 5, 2021).
+Added: Certificate of Designation of Series B Cumulative Preferred Stock of Harrow Health, Inc.
+Added: (incorporated herein by reference to Exhibit 3.1 to the Current Report on Form 8-K of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on May 5, 2021)
Description of the Company’s Securities
−Removed: Indenture, dated as of April 20, 2021, by and between the Company and U.S.
−Removed: Bank National Association, as Trustee (incorporated herein by reference to Exhibit 4.1 to the Current Report on Form 8-K of the Company filed with the Securities and Exchange Commission on April 20, 2021).
−Removed: First Supplemental Indenture, dated as of April 20, 2021, by and between the Company and U.S.
−Removed: Bank National Association, as Trustee (incorporated herein by reference to Exhibit 4.2 to the Current Report on Form 8-K of the Company filed with the Securities and Exchange Commission on April 20, 2021).
−Removed: Form of 8.625% Senior Note due 2026 (included in Exhibit 4.3).
+Added: Indenture dated April 20, 2021 between Harrow Health, Inc.
+Added: Bank National Association, as Trustee (incorporated herein by reference to Exhibit 4.1 to the Current Report on Form 8-K of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on April 20, 2021).
+Added: First Supplemental Indenture dated April 20, 2021 between Harrow Health, Inc.
+Added: Bank National Association, as Trustee (incorporated herein by reference to Exhibit 4.2 to the Current Report on Form 8-K of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on April 20, 2021).
+Added: Form of 8.625% Senior Note due 2026 (incorporated herein by reference to Exhibit 4.3 to the Current Report on Form 8-K of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on April 20, 2021).
+Added: Second Supplemental Indenture dated December 20, 2022 between Harrow Health, Inc.
+Added: Bank Trust Company, National Association (incorporated herein by reference to Exhibit 4.2 to the Current Report on Form 8-K of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on December 20, 2022).
+Added: Form of 11.875% Senior Note due 2027 (incorporated herein by reference to Exhibit 4.3 to the Current Report on Form 8-K of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on December 20, 2022).
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.
13 unchanged sentences
filed with the Securities and Exchange Commission on May 8, 2013)
+Added: Stand-alone Restricted Stock Unit Agreement, dated July 18, 2012, granted by Imprimis Pharmaceuticals, Inc.
+Added: Baum (incorporated herein by reference to Exhibit 10.40 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-182846) filed on July 25, 2012)
+Added: Stand-alone Restricted Stock Unit Agreement, dated July 18, 2012, granted by Imprimis Pharmaceuticals, Inc.
+Added: Kammer (incorporated herein by reference to Exhibit 10.41 to the Company’s Registration Statement on Form S-1 (File No.
+Added: 333-182846) filed on July 25, 2012)
+Added: 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.
+Added: 333-182846) filed on October 26, 2012)
Employment Agreement, dated as of April 25, 2016, by and between Imprimis Pharmaceuticals, Inc.
−Removed: Baum (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc.
−Removed: filed with the Securities and Exchange Commission on April 26, 2016)
+Added: Baum (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 26, 2016)
+Added: Stock Units Agreement, dated May 2, 2013, by and between Imprimis Pharmaceuticals, Inc.
+Added: Baum (incorporated herein by
+Added: reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q filed with the
+Added: Securities and Exchange Commission on August 14, 2013)
Employment Agreement, dated as of April 25, 2016, by and between Imprimis Pharmaceuticals, Inc.
and Andrew R.
−Removed: Boll (incorporated herein by reference to Exhibit 10.4 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc.
−Removed: filed with the Securities and Exchange Commission on April 26, 2016)
+Added: Boll (incorporated herein by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 26, 2016)
+Added: Performance Stock Units Award Agreement, effective as of February 1, 2015, by and between Imprimis Pharmaceuticals, Inc.
+Added: and Andrew R.
+Added: Boll (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 2, 2015)
Employment Agreement, dated as of April 25, 2016, by and between Imprimis Pharmaceuticals, Inc.
−Removed: Saharek (incorporated herein by reference to Exhibit 10.7 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc.
−Removed: filed with the Securities and Exchange Commission on April 26, 2016)
+Added: Saharek (incorporated herein by reference to Exhibit 10.7 to the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 26, 2016)
+Added: Warrant to Purchase Stock, dated May 11, 2015, issued by Imprimis Pharmaceuticals, Inc.
+Added: (incorporated herein by reference to Exhibit 10.2 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc.
+Added: filed with the Securities and Exchange Commission on May 12, 2015)
+Added: Warrant Amendment to Purchase Stock, dated December 27, 2016, issued by Imprimis Pharmaceuticals, Inc.
+Added: (incorporated herein by reference to Exhibit 10.3 to the Current Report on Form 8-K of Imprimis Pharmaceuticals, Inc.
+Added: filed with the Securities and Exchange Commission on December 29, 2016)
+Added: 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.
+Added: filed with the Securities and Exchange Commission on March 22, 2017)
License Agreement dated April 1, 2017 between Imprimis Pharmaceuticals, Inc.
117 unchanged sentences
filed with the Securities and Exchange Commission on November 9, 2020).
−Removed: Securities Purchase Agreement, dated as of May 5, 2021, by and between the Company and B.
−Removed: Riley Securities, Inc.
−Removed: (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed with the Securities and Exchange Commission on May 5, 2021).
−Removed: License and Supply Agreement, dated as of July 25, 2021, by and between the Company and Sintetica, S.A.
−Removed: (incorporated herein by reference to Exhibit 10.2+ to the Current Report on Form 10-Q of the Company filed with the Securities and Exchange Commission on August 10, 2021).
+Added: Expansion Term Letter Agreement dated December 6, 2021 between Eyepoint Pharmaceuticals, Inc.
+Added: and ImprimisRx, LLC (incorporated herein by reference to Exhibit 10.50 to the Annual Report on Form 10-K of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on March 10, 2022)
+Added: Mutual Termination Agreement dated October 7, 2022 between ImprimisRx and EyePoint Pharmaceuticals, Inc.
+Added: (incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on November 14, 2022)
+Added: License and Supply Agreement dated July 25, 2021 between Harrow Health, Inc.
+Added: and Sintetica, S.A.
+Added: (incorporated herein by reference to Exhibit 10.2 to the Current Report on Form 10-Q of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on August 10, 2021)
+Added: Harrow Health, Inc.
+Added: 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.
+Added: filed with the Securities and Exchange Commission on August 25, 2017)
First Amendment to the Harrow Health, Inc.
−Removed: 2017 Incentive Stock and Awards Plan (incorporated herein by reference to Appendix A to the Company’s Definitive Proxy Statement filed with the SEC on April 23, 2021).
−Removed: Loan and Security Agreement, dated September 1, 2021, by and between the Company and Melt Pharmaceuticals, Inc.
−Removed: (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of the Company filed with the Securities and Exchange Commission on September 2, 2021).
−Removed: Basic Sale and Purchase Agreement, dated as of August 18, 2021, by and between the Company and Wakamoto Pharmaceutical Co., Ltd.
−Removed: (incorporated herein by reference to Exhibit 10.3+ to the Current Report on Form 10-Q of the Company filed with the Securities and Exchange Commission on November 9, 2021).
−Removed: License Agreement, dated as of August 18, 2021, by and between the Company and Wakamoto Pharmaceutical Co., Ltd.
−Removed: (incorporated herein by reference to Exhibit 10.4+ to the Current Report on Form 10-Q of the Company filed with the Securities and Exchange Commission on November 9, 2021).
−Removed: Expansion Term Letter Agreement between Eyepoint Pharmaceuticals, Inc.
−Removed: and ImprimisRx, LLC dated December 6, 2021.
−Removed: Asset Purchase Agreement, dated as of December 17, 2021, by and between the Company and Novartis Technology, LLC and Novartis Ophthalmics AG
+Added: 2017 Incentive Stock and Awards Plan (incorporated herein by reference to Appendix A to Harrow Health, Inc.’s Definitive Proxy Statement filed with the Securities and Exchange Commission on April 23, 2021)
+Added: Loan and Security Agreement dated September 1, 2021 among Harrow Health, Inc.
+Added: and Melt Pharmaceuticals, Inc.
+Added: (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 8-K of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on September 2, 2021)
+Added: First Amendment to Loan and Security Agreement dated April 8, 2022 between Harrow Health, Inc.
+Added: and Melt Pharmaceuticals, Inc.
+Added: (incorporated herein by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on November 14, 2022)
+Added: Second Amendment to Loan and Security Agreement dated September 21, 2022 between Harrow Health, Inc.
+Added: and Melt Pharmaceuticals, Inc.
+Added: (incorporated herein by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on November 14, 2022)
+Added: Basic Sale and Purchase Agreement dated August 18, 2021 between Harrow Health, Inc.
+Added: and Wakamoto Pharmaceutical Co., Ltd.
+Added: (incorporated herein by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on November 9, 2021)
+Added: License Agreement dated August 18, 2021 between Harrow Health, Inc.
+Added: and Wakamoto Pharmaceutical Co., Ltd.
+Added: (incorporated herein by reference to Exhibit 10.4 to the Quarterly Report on Form 10-Q of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on November 9, 2021)
+Added: Asset Purchase Agreement dated December 17, 2021 between Harrow Health, Inc.
+Added: and Novartis Technology, LLC and Novartis Ophthalmics AG (incorporated herein by reference to Exhibit 10.51 to the Annual Report on Form 10-K of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on March 10, 2022)
+Added: Asset Purchase Agreement dated December 13, 2022 between Harrow Health, Inc.
+Added: and Novartis Technology, LLC and Novartis Innovative Therapies AG (incorporated herein by reference to Exhibit 10.1 to the Current Report on Form 10-K of Harrow Health, Inc.
+Added: filed with the Securities and Exchange Commission on December 14, 2022).
List of Subsidiaries
18 unchanged sentences
XBRL Taxonomy Extension Presentation Linkbase Document
−Removed: cover page from the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 has been formatted in
+Added: cover page from the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 has been formatted in Inline
contract or compensatory plan or arrangement.
24 unchanged sentences
Lawrence Van Horn
+Added: Martin Makary
to Consolidated Financial Statements
6 unchanged sentences
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
−Removed: the Stockholders and Board of Directors
−Removed: on the Consolidated Financial Statements
−Removed: have audited the accompanying consolidated balance sheets of Harrow Health, Inc.
−Removed: and subsidiaries (the “Company”) as of
−Removed: December 31, 2021 and 2020, the related consolidated statements of operations, stockholders’ equity and cash flows for
−Removed: each of the two years in the period ended December 31, 2021, and the related notes (collectively referred to as the
−Removed: “consolidated financial statements”).
−Removed: In our opinion, the consolidated financial statements referred to above present
−Removed: fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of
−Removed: its operations and its cash flows for each of the two years in the period ended December 31, 2021, in conformity with accounting
−Removed: principles generally accepted in the United States of America.
−Removed: consolidated financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion
−Removed: on these consolidated financial statements based on our audits.
−Removed: We are a public accounting firm registered with the Public Company Accounting
−Removed: Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with
−Removed: federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: conducted our audits in accordance with the standards of the PCAOB.
−Removed: Those standards require that we plan and perform the audit to obtain
−Removed: reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
−Removed: The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
−Removed: of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
−Removed: an opinion on the effectiveness of the Company’s internal control over financial reporting.
+Added: To the Stockholders and Board of Directors
+Added: Harrow Health, Inc.
+Added: Opinion on the Consolidated Financial Statements
+Added: We have audited the accompanying consolidated balance
+Added: sheets of Harrow Health, Inc.
+Added: and subsidiaries (the “Company”) as of December 31, 2022 and 2021, the related consolidated
+Added: statements of operations, stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2022,
+Added: and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated
+Added: financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31,
+Added: 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in
+Added: conformity with accounting principles generally accepted in the United States of America.
+Added: Basis for Opinion
+Added: These consolidated financial statements are the responsibility
+Added: of the Company’s management.
+Added: Our responsibility is to express an opinion on these consolidated financial statements based on our
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)
+Added: and are required to be independent with respect to the Company in accordance with the U.S.
+Added: federal securities laws and the applicable
+Added: rules and regulations of the Securities and Exchange Commission and the PCAOB.
+Added: We conducted our audits in accordance with the standards
+Added: of the PCAOB.
+Added: Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated
+Added: financial statements are free of material misstatement, whether due to error or fraud.
+Added: The Company is not required to have, nor were we
+Added: engaged to perform, an audit of its internal control over financial reporting.
+Added: As part of our audits, we are required to obtain an understanding
+Added: of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
+Added: internal control over financial reporting.
Accordingly, we express no such opinion.
−Removed: audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
−Removed: due to error or fraud, and performing procedures that respond to those risks.
−Removed: Such procedures included examining, on a test basis, evidence
−Removed: regarding the amounts and disclosures in the consolidated financial statements.
−Removed: Our audits also included evaluating the accounting principles
−Removed: used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
−Removed: We believe that our audits provide a reasonable basis for our opinion.
−Removed: critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that
−Removed: was communicated or required to be communicated to the audit committee and that:
−Removed: (1) relates to accounts or disclosures that are material
−Removed: to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication
−Removed: of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we
−Removed: are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts
−Removed: or disclosures to which it relates.
−Removed: for Investments in Melt Pharmaceuticals, Inc.
−Removed: Audit Matter Description
−Removed: described in Notes 2 and 4 to the consolidated financial statements, the Company has investments in Melt Pharmaceuticals, Inc.
−Removed: which it records under the equity method of accounting.
−Removed: The structure and related agreements between the Company and Melt need to be
−Removed: evaluated for consolidation, including determining whether Melt is a variable interest entity (“VIE”), and if so, whether
−Removed: the Company is the primary beneficiary.
−Removed: This assessment was performed at the formation of Melt and upon the occurrence of reconsideration
−Removed: This determination requires significant judgment by management.
−Removed: of December 31, 2021, the carrying value of the Company’s investments in Melt was $11.1 million.
−Removed: identified the accounting for the Company’s investments in Melt, including the primary beneficiary assessment upon the occurrence
−Removed: of reconsideration events, as a critical audit matter given the complex nature of the relevant accounting guidance, as well as the significant
−Removed: judgment required by management.
−Removed: This required a high degree of auditor judgment and an increased extent of audit effort due to the nature
−Removed: and complexity of the agreements between the Company and Melt.
−Removed: the Critical Audit Matter Was Addressed in the Audit
−Removed: audit procedures related to the accounting determination for the investments in Melt, including the primary beneficiary assessment upon
−Removed: the occurrence of reconsideration events, included obtaining an understanding of management’s assessment of the accounting treatment
−Removed: of the investments through examination of the related agreements and evaluation of management’s analysis of the significant terms
−Removed: and characteristics of the investments, the relevant accounting guidance and conclusions.
−Removed: We evaluated management’s conclusions
−Removed: regarding the accounting for the investments in Melt and considered whether management appropriately determined if Melt is a variable
−Removed: interest entity, and if so, appropriately determined the primary beneficiary by considering contractual arrangements of Melt to evaluate
−Removed: if the Company has the power to direct activities and the obligation to absorb losses of Melt or the right to receive benefits from Melt
−Removed: that could be significant to the variable interest.
−Removed: also evaluated evidence obtained in other areas of the audit to determine if there were additional reconsideration events that had not
−Removed: been identified by the Company, including, among others, reading board minutes of Melt and reading and analyzing all relevant provisions
−Removed: of the agreements between the Company and Melt.
−Removed: We further assessed the completeness and accuracy of management’s classification
−Removed: and disclosure of the Company’s investments in Melt.
−Removed: KMJ Corbin & Company LLP
−Removed: have served as the Company’s auditor since 2007.
+Added: Our audits included performing procedures to assess
+Added: the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures
+Added: that respond to those risks.
+Added: Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
+Added: consolidated financial statements.
+Added: Our audits also included evaluating the accounting principles used and significant estimates made by
+Added: management, as well as evaluating the overall presentation of the consolidated financial statements.
+Added: We believe that our audits provide
+Added: a reasonable basis for our opinion.
+Added: Critical Audit Matter
+Added: The critical audit matter communicated below is
+Added: a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated
+Added: to the audit committee and that:
+Added: (1) relates to accounts or disclosures that are material to the consolidated financial statements and
+Added: (2) involved our especially challenging, subjective, or complex judgments.
+Added: The communication of the critical audit matter does not alter
+Added: in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit
+Added: matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
+Added: Product Sales Deductions – Branded Products
+Added: Critical Audit Matter Description
+Added: As described in Note 3 to the consolidated financial
+Added: statements, revenues from branded product sales are recognized net of accruals for estimated rebates, wholesaler chargebacks, discounts
+Added: and other deductions (collectively, “sales deductions”), which are established at the time of sale.
+Added: Management’s estimate
+Added: of sales deductions for branded products is based on the inventory levels in the distribution channel as provided by wholesalers, as well
+Added: as the actual average selling price for each product which is impacted by changes in customer mix, changes in negotiated terms with customers,
+Added: and changes in the volume of purchases.
+Added: In addition, management utilizes the services of a third-party professional services firm to estimate
+Added: rebates and chargebacks associated with sales of its branded products.
+Added: We identified the estimates of accruals for sales
+Added: deductions as a critical audit matter given the limited sales history of the Company’s branded products and the significant judgment
+Added: required by management with respect to the measurement uncertainty, as the calculation of the sales deductions includes assumptions such
+Added: as average selling price, purchasing trends of wholesalers and historical branded product sales used to predict future sales.
+Added: This required
+Added: a high degree of auditor judgment and an increased extent of audit effort in applying the procedures related to management’s assumptions.
+Added: How the Critical Audit Matter Was Addressed in
+Added: To test management’s estimated branded product
+Added: sales deductions, we obtained management’s calculations for the respective estimates and performed the following procedures, among
+Added: We tested management’s estimation process for determining accruals for product sales deductions by developing an independent
+Added: expectation of the estimated accrual rates, including comparison of rates used in management’s analysis to external industry data,
+Added: historical actual information, and executed third-party contracts.
+Added: We evaluated management’s historic ability to accurately estimate
+Added: the sales deduction accruals by retrospectively comparing historically recorded accruals to the actual amounts that were ultimately claimed
+Added: by the wholesalers.
+Added: In addition, we assessed subsequent events to determine whether there was any new information that would require adjustment
+Added: to the accruals.
+Added: /s/ KMJ Corbin & Company LLP
+Added: We have served as the Company’s auditor since 2007.
+Added: Irvine, California
March 23, 2023
−Removed: BALANCE SHEETS
−Removed: thousands, except share data)
−Removed: and cash equivalents, including restricted cash of $ 200 at December 31, 2020
−Removed: in Eton Pharmaceuticals
−Removed: receivable, net
−Removed: expenses and other current assets
+Added: HARROW HEALTH, INC.
+Added: CONSOLIDATED BALANCE SHEETS
Current assets
−Removed: plant and equipment, net
−Removed: software development costs, net
−Removed: lease right-of-use assets
−Removed: in Surface Pharmaceuticals
−Removed: in Melt Pharmaceuticals
−Removed: AND STOCKHOLDERS’ EQUITY
−Removed: payable and accrued expenses
−Removed: payroll and related liabilities
−Removed: revenue and customer deposits
−Removed: portion of loans payable, net of unamortized debt discount
−Removed: portion of operating lease obligations
−Removed: portion of finance lease obligations
+Added: Cash and cash equivalents
+Added: Investment in Eton Pharmaceuticals
+Added: Accounts receivable, net
+Added: Prepaid expenses and other current assets
+Added: Total current assets
+Added: Property, plant and equipment, net
+Added: Capitalized software costs, net
+Added: Deferred financing costs
+Added: Operating lease right-of-use assets, net
+Added: Intangible assets, net
+Added: Investment in Melt Pharmaceuticals
+Added: $ 157,378,000
+Added: LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
−Removed: lease liabilities, net of current portion
−Removed: lease obligations, net of current portion
−Removed: expenses, net of current portion
−Removed: payable, net of current portion and unamortized debt discount
−Removed: and contingencies
−Removed: STOCKHOLDERS’
−Removed: stock, $ 0.001 par value, 50,000,000 shares authorized, 26,902,763 and 25,749,875 shares issued and outstanding at December 31, 2021
−Removed: and December 31, 2020, respectively
−Removed: paid-in capital
−Removed: HARROW HEALTH STOCKHOLDERS’ EQUITY
−Removed: Noncontrolling
+Added: Accounts payable and accrued expenses
+Added: Accrued payroll and related liabilities
+Added: Deferred revenue and customer deposits
+Added: Current portion of operating lease obligations
+Added: Current portion of finance lease obligations
+Added: Total current liabilities
+Added: Operating lease obligations, net of current portion
+Added: Finance lease obligations, net of current portion
+Added: Notes payable, net of unamortized debt discount
+Added: TOTAL LIABILITIES
+Added: Commitments and contingencies
STOCKHOLDERS’ EQUITY
−Removed: LIABILITIES AND STOCKHOLDERS’ EQUITY
−Removed: accompanying notes are an integral part of these consolidated financial statements
+Added: Common stock, $ 0.001 par value, 50,000,000 shares authorized, 29,901,530 and 26,902,763
+Added: shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively
+Added: Additional paid-in capital
+Added: Accumulated deficit
+Added: ( 109,493,000 )
+Added: ( 95,407,000 )
+Added: TOTAL HARROW HEALTH STOCKHOLDERS’ EQUITY
+Added: Noncontrolling interests
+Added: TOTAL STOCKHOLDERS’ EQUITY
+Added: TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
+Added: $ 157,378,000
+Added: The accompanying notes are an integral part of these consolidated financial statements
+Added: HARROW HEALTH, INC.
STATEMENTS OF OPERATIONS
−Removed: thousands, except for share and per share data)
−Removed: the Years Ended
−Removed: general and administrative
−Removed: and development
−Removed: of long-lived assets
+Added: Product sales, net
+Added: Other revenues
+Added: Total revenues
+Added: Cost of sales
+Added: ( 25,383,000 )
+Added: ( 18,214,000 )
Operating expenses:
−Removed: from operations
−Removed: income (expense):
−Removed: in losses of unconsolidated entities
−Removed: (loss) gain from investment in Eton Pharmaceuticals, net
−Removed: on early extinguishment of debt
−Removed: on forgiveness of PPP loan
−Removed: income (expense), net
−Removed: other expense, net
−Removed: before income tax provision
−Removed: tax provision, net
−Removed: net loss including noncontrolling interests
−Removed: loss attributable to noncontrolling interests
−Removed: loss attributable to Harrow Health, Inc.
−Removed: dividends and accretion of preferred stock issuance costs
−Removed: loss attributable to common stockholders
−Removed: and diluted net loss per share of common stock
−Removed: average number of shares of common stock outstanding, basic and diluted
−Removed: accompanying notes are an integral part of these consolidated financial statements
−Removed: STATEMENTS OF STOCKHOLDERS’ EQUITY
−Removed: the years ended December 31, 2021 and 2020
−Removed: thousands, except for share data)
+Added: Selling, general and administrative
+Added: Research and development
+Added: Impairment of long-lived assets
+Added: Total operating expenses
+Added: Income from operations
+Added: Other income (expense):
+Added: Interest expense, net
+Added: ( 7,244,000 )
+Added: ( 5,436,000 )
+Added: Equity in losses of unconsolidated entities
+Added: ( 11,133,000 )
+Added: ( 5,334,000 )
+Added: Investment loss from Eton Pharmaceuticals
+Added: ( 2,914,000 )
+Added: ( 10,126,000 )
+Added: Loss on early extinguishment of debt
+Added: Gain on forgiveness of PPP loan
+Added: Gain on sale of non-ophthalmology assets
+Added: Other income, net
+Added: Total other expense, net
+Added: ( 15,930,000 )
+Added: ( 19,488,000 )
+Added: Loss before income tax provision
+Added: ( 14,011,000 )
+Added: ( 17,874,000 )
+Added: Income tax provision
+Added: ( 14,086,000 )
+Added: ( 18,007,000 )
+Added: Preferred dividends and accretion of preferred stock issuance costs
+Added: Net loss attributable to common stockholders
+Added: $ ( 14,086,000 )
+Added: $ ( 18,479,000 )
+Added: Basic and diluted net loss per share of common stock
+Added: Weighted average number of shares of common stock outstanding, basic and
+Added: The accompanying notes are
+Added: an integral part of these consolidated financial statements
+Added: HARROW HEALTH, INC.
+Added: CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
+Added: For the years ended December 31, 2022 and 2021
+Added: Preferred Stock
+Added: Harrow Health, Inc.
Noncontrolling
1 unchanged sentence
Stockholders’
−Removed: at December 31, 2019
−Removed: of common stock in connection with:
−Removed: of employee stock-based options
−Removed: of warrants , Shares
−Removed: withheld related to net share settlement of equity awards
−Removed: withheld related to net share settlement of equity awards , shares
−Removed: of preferred shares, net of discounts and issuance costs
−Removed: of preferred shares, net of discounts and issuance costs, shares
−Removed: of preferred shares
−Removed: of preferred shares, shares
−Removed: of preferred dividends
−Removed: payment for services provided
−Removed: compensation expense
−Removed: at December 31, 2020
−Removed: of common stock in connection with:
−Removed: of employee stock-based options
−Removed: withheld related to net share settlement of equity awards
−Removed: of preferred shares, net of discounts and issuance costs
−Removed: of preferred shares
−Removed: of preferred dividends
−Removed: compensation expense
−Removed: at December 31, 2021
−Removed: accompanying notes are an integral part of these consolidated financial statements
+Added: Balance at December 31, 2020
+Added: $ 104,557,000
+Added: $ ( 77,400,000 )
+Added: $ ( 355,000 )
+Added: Issuance of common stock in connection with:
+Added: Exercise of employee stock-based options
+Added: Exercise of warrants
+Added: Vesting of RSUs
+Added: Shares withheld related to net share settlement of equity awards
+Added: ( 3,228,000 )
+Added: ( 3,228,000 )
+Added: ( 3,228,000 )
+Added: Issuance of preferred shares, net of discounts and issuance costs
+Added: Redemption of preferred shares
+Added: ( 11,000,000 )
+Added: ( 11,000,000 )
+Added: ( 11,000,000 )
+Added: Payment of preferred dividends
+Added: Stock-based compensation expense
+Added: ( 18,007,000 )
+Added: ( 18,007,000 )
+Added: ( 18,007,000 )
+Added: Balance at December 31, 2021
+Added: $ 106,666,000
+Added: $ ( 95,407,000 )
+Added: $ ( 355,000 )
+Added: Beginning balance
+Added: $ 106,666,000
+Added: $ ( 95,407,000 )
+Added: $ ( 355,000 )
+Added: Issuance of common stock in connection with:
+Added: Exercise of consultant stock-based options
+Added: Exercise of employee stock-based options
+Added: Exercise of warrants
+Added: Vesting of RSUs
+Added: Shares withheld related to net share settlement of equity awards
+Added: Issuance of common shares from public offering, net of offering costs
+Added: Stock-based compensation expense
+Added: ( 14,086,000 )
+Added: ( 14,086,000 )
+Added: ( 14,086,000 )
+Added: Balance at December 31, 2022
+Added: $ 137,058,000
+Added: $ ( 109,493,000 )
+Added: $ ( 355,000 )
+Added: Ending balance
+Added: $ 137,058,000
+Added: $ ( 109,493,000 )
+Added: $ ( 355,000 )
+Added: The accompanying notes are an integral part of these consolidated financial statements
+Added: HARROW HEALTH, INC.
STATEMENTS OF CASH FLOWS
−Removed: the Years Ended
−Removed: FLOWS FROM OPERATING ACTIVITIES
−Removed: loss (including noncontrolling interests)
−Removed: to reconcile net loss to net cash provided by (used in) operating
−Removed: and amortization
−Removed: of intangible assets
−Removed: of operating lease right-of-use assets
−Removed: for bad debt expense
−Removed: paid-in-kind on SWK Loan
−Removed: of debt issuance costs and discount
−Removed: on forgiveness of PPP loan
−Removed: loss (gain) from investment in Eton
−Removed: in losses of unconsolidated entities
−Removed: on sale and disposal of equipment
−Removed: on early extinguishment of loan
−Removed: of long-lived assets
−Removed: based payment of consulting services
−Removed: in assets and liabilities:
−Removed: expenses and other current assets
−Removed: payable and accrued expenses
−Removed: payroll and related liabilities
−Removed: revenue and customer deposits
−Removed: CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES
−Removed: FLOWS FROM INVESTING ACTIVITIES
−Removed: proceeds from sale of investment in Eton Pharmaceuticals
−Removed: of note receivable, Melt Pharmaceuticals
−Removed: from sale and disposal of assets
−Removed: in patent and trademark assets
−Removed: of product NDAs and patents
−Removed: of property, plant and equipment and capitalized software development costs
−Removed: CASH USED IN INVESTING ACTIVITIES
−Removed: FLOWS FROM FINANCING ACTIVITIES
−Removed: on finance lease obligations
+Added: For the Years Ended
+Added: CASH FLOWS FROM OPERATING ACTIVITIES
+Added: $ ( 14,086,000 )
+Added: $ ( 18,007,000 )
+Added: Adjustments to reconcile net loss to net cash provided by operating activities:
+Added: Depreciation and amortization of property, plant and equipment
+Added: Amortization of intangible assets
+Added: Amortization of operating lease right-of-use assets
+Added: Provision for bad debt expense
+Added: Amortization of debt issuance costs and discount
+Added: Gain on forgiveness of PPP loan
+Added: ( 1,967,000 )
+Added: Investment loss from Eton Pharmaceuticals
+Added: Equity in losses of unconsolidated entities
+Added: Loss on disposal of equipment
+Added: Loss on early extinguishment of loan
+Added: Impairment of long-lived assets
+Added: Stock-based compensation
+Added: Gain on sale of non-ophthalmology assets
+Added: ( 5,259,000 )
+Added: Changes in assets and liabilities:
+Added: Accounts receivable
+Added: ( 1,860,000 )
+Added: ( 1,831,000 )
+Added: ( 2,324,000 )
+Added: Prepaid expenses and other current assets
+Added: ( 4,256,000 )
+Added: Accounts payable and accrued expenses
+Added: Accrued payroll and related liabilities
+Added: Deferred revenue and customer deposits
+Added: NET CASH PROVIDED BY OPERATING ACTIVITIES
+Added: CASH FLOWS FROM INVESTING ACTIVITIES
+Added: Net proceeds from sale of investments
+Added: Issuance of note receivable, Melt Pharmaceuticals
+Added: ( 12,592,000 )
+Added: Proceeds from sale of non-ophthalmology assets
+Added: Proceeds from sale of property, plant and equipment
+Added: Investment in patent and trademark assets
+Added: Purchase of licenses, product NDAs and patents
+Added: ( 5,000,000 )
+Added: ( 14,050,000 )
+Added: Purchases of property, plant and equipment
+Added: ( 2,597,000 )
+Added: ( 1,786,000 )
+Added: NET CASH USED IN INVESTING ACTIVITIES
+Added: ( 1,743,000 )
+Added: ( 18,686,000 )
+Added: CASH FLOWS FROM FINANCING ACTIVITIES
+Added: Payments on finance lease obligations
Proceeds from 8.625% notes payable, net of costs
−Removed: and exit fee payments on SWK loan
−Removed: proceeds from PPP loan payable
−Removed: from SWK debt, net of costs
−Removed: of taxes upon vesting of RSUs
−Removed: from exercise of stock options
−Removed: of preferred stock, net of discount and issuance costs
−Removed: of preferred stock
−Removed: of preferred stock dividends
−Removed: CASH PROVIDED BY FINANCING ACTIVITIES
−Removed: CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
−Removed: CASH EQUIVALENTS AND RESTRICTED CASH, beginning of year
−Removed: CASH EQUIVALENTS AND RESTRICTED CASH, end of year
−Removed: RECONCILIATION
−Removed: OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH
−Removed: and cash equivalents
−Removed: CASH EQUIVALENTS AND RESTRICTED CASH AT END OF YEAR
−Removed: DISCLOSURE OF CASH FLOW INFORMATION:
−Removed: paid for income taxes
−Removed: paid for interest
−Removed: DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
−Removed: of property, plant and equipment included in accounts payable and accrued expenses
−Removed: reduction in right-of-use assets and lease obligations due to modifications
−Removed: accounts receivable transferred to note receivable
−Removed: accompanying notes are an integral part of these consolidated financial statements
+Added: Proceeds from 11.875% notes payable, net of costs
+Added: Principal and exit fee payments on SWK loan
+Added: ( 15,961,000 )
+Added: Proceeds from common stock, net of offering costs
+Added: Payment of taxes upon vesting of RSUs
+Added: ( 3,228,000 )
+Added: Proceeds from exercise of stock options
+Added: Sale of preferred stock, net of discount and issuance costs
+Added: Repayment of preferred stock
+Added: ( 11,000,000 )
+Added: Payment of preferred stock dividends
+Added: NET CASH PROVIDED BY FINANCING ACTIVITIES
+Added: NET CHANGE IN CASH AND CASH EQUIVALENTS
+Added: CASH AND CASH EQUIVALENTS, beginning of year
+Added: CASH AND CASH EQUIVALENTS, end of year
+Added: SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
+Added: Cash paid for income taxes
+Added: Cash paid for interest
+Added: SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING
+Added: Purchase of property, plant and equipment included in
+Added: accounts payable and accrued expenses
+Added: Purchase of intangible asset included in accounts payable and accrued expenses
+Added: Right-of-use assets obtained in exchange for new operating lease obligations
+Added: Net reduction in right-of-use assets and lease obligations due to modification
+Added: Melt accounts receivable transferred to note receivable
+Added: The accompanying notes are
+Added: an integral part of these consolidated financial statements
TO THE CONSOLIDATED FINANCIAL STATEMENTS
the Years Ended December 31, 2022 and 2021
−Removed: dollar amounts are expressed in thousands, except share and per share data)
(together with its subsidiaries, partially owned companies and royalty arrangements unless the context indicates or otherwise
−Removed: requires, the “Company” or “Harrow”) is an ophthalmic-focused healthcare company that specializes in the development,
−Removed: production and sale of innovative medications that offer unique competitive advantages and serve unmet needs in the marketplace through
−Removed: its subsidiaries and deconsolidated companies.
−Removed: The Company owns one of the nation’s leading ophthalmology-focused pharmaceutical
−Removed: businesses, ImprimisRx.
−Removed: In addition to wholly owning ImprimisRx, the Company also has non-controlling equity positions in Surface Ophthalmics,
+Added: requires, the “Company” or “Harrow”) is an eyecare pharmaceutical company exclusively focused on the discovery,
+Added: development, and commercialization of innovative ophthalmic therapies that are accessible and affordable.
+Added: Company owns non-controlling equity positions in Surface Ophthalmics, Inc.
(“Surface”) and Melt Pharmaceuticals, Inc.
−Removed: (“Melt”), both companies that began as subsidiaries of Harrow.
−Removed: In 2020, Harrow created Visionology, Inc.
−Removed: (“Visionology”), which recently launched an online eye health platform business.
−Removed: Harrow also owns royalty rights in various drug candidates being developed by Surface and Melt.
−Removed: of December 31, 2021, the Company suspended the majority of operational efforts related to its subsidiaries Stowe Pharmaceuticals, Inc.
−Removed: (“Stowe”), Radley Pharmaceuticals, Inc.
−Removed: (“Radley”) and Mayfield Pharmaceuticals, Inc.
−Removed: to allocate resources in other areas of the Company’s business.
−Removed: The suspension of these operations did not have a material impact
−Removed: on the financial results of the Company.
+Added: both companies that began as subsidiaries of Harrow.
+Added: Harrow also owns royalty rights in various drug candidates being developed by Surface
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
3 unchanged sentences
The accompanying consolidated financial statements include the accounts of the Company and its
−Removed: wholly-owned subsidiaries, as well as Mayfield and Stowe, subsidiaries of which the Company owned 79 % and 70 % of their equity interests,
−Removed: respectively, as of December 31, 2020.
−Removed: The remaining 21 % of Mayfield was owned by Elle Pharmaceutical, LLC (“Elle”), TGV-Health,
−Removed: LLC and its affiliated entities (collectively “TGV”) or other consultants.
−Removed: Mayfield was organized to develop women’s
−Removed: health-focused drug candidates.
−Removed: The remaining 30 % of Stowe was owned by TGV.
−Removed: Stowe was organized to develop ophthalmic drug candidates.
−Removed: During 2021, the Company gained control of 100% of the equity interests in Stowe and Mayfield.
−Removed: The Company controls 100 % of the equity
−Removed: interests in Visionology.
−Removed: All inter-company accounts and transactions have been eliminated in consolidation.
−Removed: Company consolidates entities in which it
−Removed: has a controlling financial interest.
−Removed: The Company assesses control under the Variable Interest Entity (“VIE”) model to
−Removed: determine whether the Company is the primary beneficiary of that entity’s operations.
−Removed: If an entity is not deemed to be a VIE,
−Removed: we consolidate entities in which we hold and/or
−Removed: control, directly or indirectly, more than 50% of the voting rights.
+Added: wholly owned and majority-owned subsidiaries.
+Added: consolidates entities in which it has a controlling financial interest.
+Added: The Company assesses control under the variable interest entity
+Added: (“VIE”) model to determine whether the Company is the primary beneficiary of that entity’s operations.
+Added: consolidates (i) entities in which it holds and/or controls, directly or indirectly, more than 50% of the voting rights , and (ii) entities
+Added: that the Company deems to be a VIE.
All intercompany accounts and transactions have been eliminated in consolidation.
3 unchanged sentences
Significant estimates made by management are, among others, allowance
−Removed: for doubtful accounts and contractual adjustments, renewal periods and discount rates for leases, realizability of inventories, recoverability
−Removed: of investments, realizability of deferred taxes, fair value of intangible assets, recoverability of long-lived assets and goodwill,
−Removed: fair value of loans payable, and valuation of stock-based transactions with employees and non-employees.
−Removed: Actual results could differ
−Removed: from those estimates.
+Added: for doubtful accounts, variable consideration determined based on accruals for chargebacks, administrative fees and rebates, government
+Added: rebates, returns and other allowances, renewal periods and discount rates for leases, realizability of inventories, recoverability of
+Added: investments, realizability of deferred taxes, goodwill and intangible assets, recoverability of long-lived assets and goodwill, fair
+Added: value of loans payable, and valuation of stock-based transactions with employees and non-employees.
+Added: Actual results could differ from
+Added: those estimates.
Uncertainties and Liquidity
4 unchanged sentences
of operations.
−Removed: Company’s chief operating decision-maker is its Chief Executive Officer who makes resource allocatio n decisions and assesses
−Removed: performance based on financial information presented as operating segments.
−Removed: Management has identified two
−Removed: operating segments as reportable segments for periods covered by this Annual Report on Form 10-K.
−Removed: See Note 18 for more information
−Removed: regarding the Company’s reportable segments.
Noncontrolling
Company recognizes any noncontrolling interest as a separate line item in equity in the consolidated financial statements.
−Removed: A noncontrolling
−Removed: interest represents the portion of equity ownership in a less-than-wholly-owned subsidiary not attributable to the Company.
+Added: noncontrolling interest represents the portion of equity ownership in a less-than-wholly-owned subsidiary not attributable to the
any interest that holds less than 50% of the outstanding voting shares is deemed to be a noncontrolling interest;
however, there are
−Removed: other factors, such as decision-making rights, that are considered as well .
−Removed: The Company includes the amount of net loss attributable
−Removed: to noncontrolling interests in consolidated net loss on the face of the consolidated statements of operations.
+Added: other factors that are considered as well, such as decision-making rights .
+Added: When applicable, and in prior periods, the
+Added: Company includes the amount of net loss attributable to noncontrolling interests in consolidated net loss on the face of the
+Added: consolidated statements of operations.
Company provides in the consolidated statements of stockholders’ equity a reconciliation at the beginning and the end of the period
2 unchanged sentences
income or loss;
−Removed: with owners acting in their capacity as owners, showing separately contributions from and distributions to owners;
+Added: with owners acting in their capacity as owners, showing separately contributions from and
+Added: distributions to owners;
component of other income or loss
+Added: noncontrolling interests in the consolidated balance sheets as of December 31, 2022 and 2021, relate to consolidated subsidiaries that
+Added: the Company owns a controlling stake in, but not 100 % of the equity interests, and that no longer have active operations, assets and
+Added: related financial activity.
+Added: a result of shifts in the Company’s strategic plans to further focus on growing the Company’s ImprimisRx business and suspension
+Added: of activities related to starting up development-stage pharmaceutical companies, along with changes to the Company’s organizational
+Added: and internal reporting structure, beginning in January 2022, management no longer evaluates the Company’s business in two segments
+Added: and instead focuses on the performance of the business as a single operating business.
Recognition and Deferred Revenue
1 unchanged sentence
to which the Company expects to be entitled in exchange for those goods or services (see Note 3).
−Removed: of sales includes direct and indirect costs to manufacture formulations and other products sold, including active pharmaceutical ingredients,
−Removed: personnel costs, packaging, storage, royalties, shipping and handling costs and the write-off of obsolete inventory.
+Added: of sales includes direct and indirect costs to manufacture formulations
+Added: and other products sold, including active pharmaceutical ingredients, personnel costs, packaging, storage, royalties, shipping and handling
+Added: costs, depreciation and amortization of certain intangible assets and the write-off of obsolete inventory.
and Development
9 unchanged sentences
expense in the accompanying consolidated statements of operations.
+Added: At December 31, 2022, the Company recorded deferred financing costs of $ 1,950,000 related to the B.
+Added: Riley Loan and
+Added: Security Agreement, which will be recorded as a debt issuance cost and net of the related BR Loan in January 2023 (see Notes 13 and 20).
costs of acquiring intellectual property rights to be used in the research and development process, including licensing fees and milestone
32 unchanged sentences
Corporation (“FDIC”) provides basic deposit coverage with limits up to $ 250,000 per owner.
−Removed: From time to time the Company has
−Removed: cash deposits in excess of FDIC limits.
−Removed: in Eton Pharmaceuticals, Inc.
+Added: In various accounts the Company
+Added: has cash deposits in excess of FDIC limits.
+Added: Investment in Eton Pharmaceuticals, Inc.
– Related Party
4 unchanged sentences
(“ASU”) 2016-01, Financial Instruments-Overall (Subtopic 825-10):
−Removed: Recognition and Measurement of Financial Assets and
−Removed: Financial Liabilities , the Company recorded an unrealized investment (loss) gain from its Eton common stock position of $ ( 8,720 )
−Removed: and $ 3,255 ,
−Removed: during the years ended December 31, 2021, respectively, related to the change in fair market value of its investment in Eton during the
−Removed: measurement period.
+Added: Recognition and Measurement of Financial Assets
+Added: and Financial Liabilities , the Company recorded an unrealized investment loss from its Eton common stock position of $( 2,914,000 ) and
+Added: $( 8,720,000 ), during the years ended December 31, 2022 and 2021, respectively, related to the change in fair market value of its investment
+Added: in Eton during the measurement period.
the year ended December 31, 2021, the Company sold 1,518,000 shares of its Eton common stock through an underwritten
1 unchanged sentence
The gross proceeds to the Company
−Removed: from the Eton Stock Sale were $ 10,626 , before deducting underwriting discounts and commissions and other offering expenses payable by
−Removed: the Company of $ 799 .
−Removed: During the year ended December 31, 2021, the Company recorded a realized loss of $ 1,406 related to the Eton Stock
−Removed: Following the Eton Stock Sale and as of December 31, 2021, the Company owns 1,982,000 shares of Eton common stock, which
−Removed: represents less than 10 % of the equity interests of Eton.
−Removed: At December 31, 2021, the fair market value of Eton’s common stock was
−Removed: $ 4.29 per share.
−Removed: As of December 31, 2021, the fair market value of the Company’s investment in Eton was $ 8,503 .
+Added: from the Eton Stock Sale were $ 10,626,000 , before deducting underwriting discounts and commissions and other offering expenses payable
+Added: by the Company of $ 799,000 .
+Added: During the year ended December 31, 2021, the Company recorded a realized loss of $ 1,406,000 related
+Added: to the Eton Stock Sale.
+Added: Following the Eton Stock Sale and as of December 31, 2022, the Company owns 1,982,000 shares
+Added: of Eton common stock, which represents less than 10 % of the equity interests of Eton.
+Added: At December 31, 2022, the fair market
+Added: value of Eton’s common stock was $ 2.82 per share.
+Added: As of December 31, 2022 and 2021, the fair market value of the Company’s
+Added: investment in Eton was $ 5,589,000 and $ 8,503,000 , respectively.
receivable are stated net of allowances for doubtful accounts and contractual adjustments.
19 unchanged sentences
– Related Party
−Removed: Company owns 3,500,000
−Removed: shares of common stock (which is approximately
−Removed: of the equity interests as of December 31, 2021) of Melt.
−Removed: The Company analyzes its investment in Melt and related agreements on a regular
−Removed: basis to evaluate its position of variable interests in Melt.
−Removed: The Company has determined that it does not have the ability to control
−Removed: Melt, however it has the ability to exercise significant influence over the operating and financial decisions of Melt, and uses the equity
−Removed: method of accounting for this investment.
−Removed: Under this method, the Company recognizes earnings and losses in Melt in its consolidated financial
−Removed: statements and adjusts the carrying amount of its investment in Melt accordingly.
−Removed: The Company’s share of earnings and losses are
−Removed: based on the Company’s ownership interest of Melt.
+Added: Company owns 3,500,000 shares of common stock of Melt (representing approximately 46 % of the equity interests as of December 31, 2022).
+Added: The Company analyzes its investment in Melt and related agreements on a regular basis to evaluate its position of variable interests
+Added: The Company has determined that it does not have the ability to control Melt, however it has the ability to exercise significant
+Added: influence over the operating and financial decisions of Melt and uses the equity method of accounting for this investment.
+Added: method, the Company recognizes earnings and losses in Melt in its consolidated financial statements and adjusts the carrying amount of
+Added: its investment in Melt accordingly.
Any intra-entity profits and losses are eliminated.
−Removed: During the year ended December
−Removed: 31, 2021, the Company reduced its common stock investment in Melt to $ 0
−Removed: as a result of the Company recording its share
−Removed: of equity losses in Melt since its deconsolidation in 2019.
−Removed: As of December 31, 2021 and at the time of entering into the Melt Loan Agreement
−Removed: (see Note 4), the Company owned 100 %
−Removed: of the debt owed by Melt.
−Removed: Following the reduction
−Removed: of the carrying value of the Company’s common stock investment in Melt to $ 0 ,
−Removed: the Company began recording 100% of the equity method losses of Melt, based on its ownership of total debt owed by Melt in accordance
−Removed: with ASC 323.
−Removed: In addition, the Company treats interest paid in kind on the Melt Loan Agreement as an in-substance capital contribution
−Removed: and reduces its investment in Melt accordingly, rather than recording interest income.
−Removed: The Company has no other requirements to advance
−Removed: funds to Melt.
+Added: During the year ended December 31, 2021, the
+Added: Company reduced the carrying value of its common stock investment in Melt to $ 0 as a result of the Company recording its share of equity
+Added: losses in Melt since its deconsolidation in 2019.
+Added: As of December 31, 2022 and 2021, and at the time of entering into the Melt Loan Agreement
+Added: (see Note 5), the Company owned 100 % of Melt’s indebtedness.
+Added: Following the reduction of the carrying value of the Company’s
+Added: common stock investment in Melt to $ 0 , the Company began recording 100 % of the equity method losses of Melt, based on its ownership of
+Added: Melt’s total indebtedness.
+Added: In addition, the Company treats interest paid in kind on the Melt Loan Agreement as an in-substance
+Added: capital contribution and reduces its investment in Melt accordingly, rather than recording interest income.
+Added: The Company has no other
+Added: requirements to advance funds to Melt.
following table summarizes the Company’s investments in Melt as of December 31, 2022:
−Removed: OF INVESTMENT
−Removed: of Equity Method
−Removed: In-substance Capital
−Removed: Contributions
+Added: SCHEDULE OF INVESTMENT
+Added: Share of Equity
+Added: Method Losses
+Added: Capital Contributions
+Added: Carrying value
+Added: $ ( 5,810,000 )
+Added: ( 13,500,000 )
+Added: ( 2,484,000 )
+Added: $ ( 19,310,000 )
+Added: $ ( 2,484,000 )
following table summarizes the Company’s investments in Melt as of December 31, 2021:
−Removed: December 31, 2021 and 2020, the Company recorded $ 48 and $ 851 , respectively, due from Melt for reimbursable expenses and amounts due
−Removed: under a Management Services Agreement between the Company and Melt (the “Melt MSA”), which are included in prepaid expenses
−Removed: and other current assets in the accompanying consolidated balance sheets.
+Added: Share of Equity
+Added: Method Losses
+Added: Capital Contributions
+Added: Carrying value
+Added: $ ( 5,810,000 )
+Added: ( 2,367,000 )
+Added: $ ( 8,177,000 )
+Added: $ ( 576,000 )
+Added: December 31, 2022 and 2021, the Company recorded $ 139,000 and $ 48,000 , respectively, due from Melt for reimbursable expenses and
+Added: amounts due under a Management Services Agreement between the Company and Melt (the “Melt MSA”), which are included in prepaid
+Added: expenses and other current assets in the accompanying consolidated balance sheets.
Note 5 for more information and related party disclosure regarding Melt.
1 unchanged sentence
– Related Party
−Removed: Company owns 3,500,000
−Removed: common shares (which is approximately 20 %
−Removed: of the equity interests following the close of a round of financing completed by Surface in July 2021) of Surface and uses the equity
−Removed: method of accounting for this investment, as management has determined that the Company has the ability to exercise significant influence
−Removed: over the operating and financial decisions of Surface.
−Removed: Under this method, the Company recognizes earnings and losses in Surface in its
−Removed: consolidated financial statements and adjusts the carrying amount of its investment in Surface accordingly.
−Removed: The Company’s share
−Removed: of earnings and losses are based on the Company’s ownership interest in Surface.
−Removed: Any intra-entity profits and losses are
−Removed: During the year ended December 31, 2021 the Company reduced its common stock investment in Surface to $ 0
−Removed: as a result of the Company recording its share
−Removed: of equity losses of Surface.
−Removed: The Company has no other investments in Surface.
−Removed: following table summarizes the Company’s investment in Surface as of December 31, 2021:
+Added: Company owns 3,500,000 common shares of Surface (representing approximately 20 % of Surface’s equity interests following the closing
+Added: of a round of financing completed by Surface in July 2021) and uses the equity method of accounting for this investment, as management
+Added: has determined that the Company has the ability to exercise significant influence over the operating and financial decisions of Surface.
+Added: Under this method, the Company recognizes earnings and losses in Surface in its consolidated financial statements and adjusts the carrying
+Added: amount of its investment in Surface accordingly.
+Added: The Company’s share of earnings and losses are based on the Company’s ownership
+Added: interest of Surface.
+Added: Any intra-entity profits and losses are eliminated.
+Added: During the year ended December 31, 2021, the Company reduced
+Added: its common stock investment in Surface to $ 0 as a result of the Company recording its share of equity losses of Surface.
+Added: has no other investments in Surface.
+Added: following table summarizes the Company’s investment in Surface as of December 31, 2022 and 2021:
SCHEDULE OF INVESTMENT
−Removed: following table summarizes the Company’s investments in Surface as of December 31, 2020:
+Added: Share of Equity Method Losses
+Added: Carrying value
+Added: $ ( 5,320,000 )
Note 6 for more information and related party disclosure regarding Surface.
−Removed: of Equity Method Investments and Note Receivable
+Added: of Equity Method Investment and Note Receivable
a quarterly basis, management assesses whether there are any indicators that the carrying value of the Company’s equity method
−Removed: investments and note receivable from Melt may be other than temporarily impaired.
−Removed: Indicators include financial condition, operating
−Removed: performance, and near-term prospects of the investee.
−Removed: To the extent indicators suggest that a loss in value may have occurred, the Company
−Removed: will evaluate both quantitative and qualitative factors to determine if the loss in value is other than temporary.
−Removed: If a potential loss
−Removed: in value is determined to be other than temporary, the Company will recognize an impairment loss based on the estimated fair value of
−Removed: the equity method investments and note receivable.
−Removed: At December 31, 2021 and 2020, no indicators of impairment existed.
+Added: investments and note receivable may be other than temporarily impaired.
+Added: Indicators include financial condition, operating performance,
+Added: and near-term prospects of the investee.
+Added: To the extent indicators suggest that a loss in value may have occurred, the Company will evaluate
+Added: both quantitative and qualitative factors to determine if the loss in value is other than temporary.
+Added: If a potential loss in value is
+Added: determined to be other than temporary, the Company will recognize an impairment loss based on the estimated fair value of the equity
+Added: method investments and note receivable.
+Added: At December 31, 2022 and December 31, 2021, no indicators of impairment existed.
Plant and Equipment
6 unchanged sentences
over three to five years .
−Removed: Software Development Costs
+Added: Software Costs
Company capitalizes certain costs related to the development of internal-use software.
4 unchanged sentences
Internal-use software
−Removed: is amortized on a straight-line basis over the estimated useful life of the asset, which ranges from two
−Removed: When internal-use software that was previously
−Removed: capitalized is abandoned, the cost less the accumulated amortization, if any, is recorded as amortization expense.
−Removed: Fully amortized capitalized
−Removed: internal-use software costs are removed from their respective accounts.
−Removed: Company accounts for business combinations by recognizing the assets acquired, liabilities assumed, contractual contingencies, and contingent
−Removed: consideration at their fair values on the acquisition date.
−Removed: The purchase price allocation process requires management to make significant
−Removed: estimates and assumptions, especially with respect to intangible assets, estimated contingent consideration payments and pre-acquisition
−Removed: contingencies.
−Removed: Examples of critical estimates in valuing certain of the intangible assets the Company has acquired or may acquire in
−Removed: the future include but are not limited to:
−Removed: expected cash flows from product sales, support agreements, consulting contracts, other customer
−Removed: contracts, and acquired developed technologies and patents;
−Removed: rates utilized in valuation estimates.
−Removed: Unanticipated
−Removed: events and circumstances may occur that may affect the accuracy or validity of such assumptions, estimates or actual results.
−Removed: Additionally,
−Removed: any change in the fair value of the acquisition-related contingent consideration subsequent to the acquisition date, including changes
−Removed: from events after the acquisition date, such as changes in our estimates of relevant revenue or other targets, will be recognized in
−Removed: earnings in the period of the estimated fair value change.
−Removed: A change in fair value of the acquisition-related contingent consideration
−Removed: or the occurrence of events that cause results to differ from our estimates or assumptions could have a material effect on the consolidated
−Removed: financial position, statements of operations or cash flows in the period of the change in the estimate.
+Added: is amortized on a straight-line basis over the estimated useful life of the asset, which ranges from two to five years .
+Added: When internal-use
+Added: software that was previously capitalized is abandoned, the cost less the accumulated amortization, if any, is recorded as amortization
+Added: Fully amortized capitalized internal-use software costs are removed from their respective accounts.
and Intangible Assets
8 unchanged sentences
straight-line method.
−Removed: Trademarks are an indefinite life intangible asset and are assessed for impairment based on future projected cash
+Added: Trademarks are an indefinite-lived intangible asset and are assessed for impairment based on future projected cash
flows as further described below.
3 unchanged sentences
considered as impairment indicators include but are not limited to the following:
−Removed: ● significant
underperformance of the Company’s business relative to expected operating results;
−Removed: ● significant
−Removed: adverse economic and industry trends;
−Removed: ● significant
−Removed: decline in the Company’s market capitalization for an extended period of time relative
−Removed: to net book value;
−Removed: ● expectations
−Removed: that a reporting unit will be sold or otherwise disposed.
+Added: significant adverse economic and industry trends;
+Added: significant decline in the Company’s market capitalization for an extended period of time relative to net book value;
+Added: expectations that a reporting unit will be sold or otherwise disposed.
goodwill impairment test consists of a two-step process as follows:
26 unchanged sentences
in the appropriate asset and liability sections of the consolidated balance sheet, if material.
+Added: the inception of a contract the Company determines if the arrangement is, or contains, a lease.
+Added: Operating lease right-of-use (“ROU”)
+Added: assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent its obligation
+Added: to make lease payments arising from the lease.
+Added: Operating lease ROU assets and liabilities are recognized at commencement date based on
+Added: the present value of lease payments over the lease term.
+Added: Rent expense is recognized on a straight-line basis over the lease term.
+Added: Company has made certain accounting policy elections whereby it (i) does not recognize ROU assets or lease liabilities for short-term
+Added: leases (those with original terms of 12-months of less) and (ii) combines lease and non-lease elements of its operating leases.
+Added: December 31, 2022, the Company did not have any finance leases.
Value Measurements
16 unchanged sentences
would relate to forecasts of future earnings and cash flows used in a discounted future cash flows method.
−Removed: The Company’s financial instruments include
−Removed: cash and cash equivalents, restricted cash, investment in Eton, accounts receivable, accounts payable and accrued expenses, accrued payroll
−Removed: and related liabilities, deferred revenue and customer deposits and the Notes.
−Removed: The carrying amount of these financial instruments, except
−Removed: for the investment in Eton and the Notes (see Note 13), approximates fair value due to the short-term maturities of these instruments.
−Removed: The Company’s restricted cash which is comprised of short-term investments are carried at amortized cost, which approximates fair
−Removed: December 31, 2021 and 2020, the Company measured its investment in Eton at fair value on a recurring basis.
−Removed: The Company’s
−Removed: investment in Eton is classified as Level 1 as the fair value is determined using quoted market prices in active markets for the same
−Removed: As of December 31, 2021 and 2020, the fair market value of the Company’s investment in Eton was $ 8,503
−Removed: and $ 28,455 ,
−Removed: respectively.
−Removed: December 31, 2021, the carrying value and fair value of the Notes were $ 71,654 and $ 78,810 , respectively.
−Removed: The Notes are classified
−Removed: as Level 1 instruments as the fair value is determined using quoted market prices in active markets for the same securities.
+Added: December 31, 2022 and 2021, the Company measured its investment in Eton on a recurring basis.
+Added: The Company’s investment in Eton
+Added: is classified as Level 1 as the fair value is determined using quoted market prices in active markets for the same securities.
+Added: December 31, 2022 and 2021, the fair market value of the Company’s investment in Eton was $ 5,589,000 and $ 8,503,000 , respectively.
+Added: Company carries the 2026 Notes at face value, including the unamortized premium, less unamortized debt issuance costs, and the 2027 Notes
+Added: are carried at face value less unamortized debt issuance costs on the consolidated balance sheets and presents fair value for disclosure
+Added: purposes only.
+Added: The 2026 Notes and 2027 Notes are classified as Level 1 instruments as the fair value is determined using quoted market
+Added: prices in active markets for the same securities.
+Added: following table presents the estimated fair values and the carrying values:
+Added: OF ESTIMATED FAIR VALUE
+Added: Carrying Value
+Added: Carrying Value
+Added: Company’s other financial instruments include cash and cash equivalents, accounts receivable, accounts payable
+Added: and accrued expenses, accrued payroll and related liabilities, deferred revenue and customer deposits and operating and finance lease
+Added: The carrying amount of these financial instruments, except for operating and finance lease liabilities, approximates fair
+Added: value due to the short-term maturities of these instruments.
+Added: Based on borrowing rates currently available to the Company, the carrying
+Added: values of the operating and finance lease liabilities approximate their respective fair values.
stock-based payments to employees, directors and consultants, including grants of stock options, warrants, restricted stock units (“RSUs”)
11 unchanged sentences
outstanding during the period.
−Removed: and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the
−Removed: Common stock equivalents (using the treasury stock or “if converted” method) from stock options, unvested
−Removed: restricted stock units (“RSUs”) and warrants were 5,646,594 and 5,411,929 at
−Removed: December 31, 2021 and 2020, respectively, and are excluded in the calculation of diluted net income per share for the periods
−Removed: presented, because the effect is anti-dilutive for that time period.
−Removed: Included in the basic and diluted net income (loss) per share
−Removed: calculation were RSUs awarded to directors that had vested, but the issuance and delivery of the shares are deferred until the
−Removed: director resigns.
−Removed: The number of shares underlying vested RSUs at December 31, 2021 and 2020 was 267,761 and 200,463 ,
−Removed: respectively.
−Removed: following table shows the computation of basic net loss per share of common stock for the years ended December 31, 2021 and 2020 (in
−Removed: 000’s, except share and per share amounts):
+Added: and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period.
+Added: Common stock equivalents (using the treasury stock or “if converted” method) from stock options, unvested restricted stock
+Added: units (“RSUs”) and warrants were 5,089,420 and 5,646,594 at December 31, 2022 and 2021, respectively, and are excluded in
+Added: the calculation of diluted net income per share for the periods presented, because the effect is anti-dilutive for that time period.
+Added: Included in the basic and diluted net income (loss) per share calculation were RSUs awarded to directors that had vested, but the issuance
+Added: and delivery of the shares are deferred until the director resigns.
+Added: The number of shares underlying vested RSUs at December 31, 2022
+Added: and 2021 was 319,859 and 267,761 , respectively.
+Added: following table shows the computation of basic net loss per share of common stock for the years ended December 31, 2022 and 2021:
OF BASIC AND DILUTED EARNINGS PER COMMON SHARE
−Removed: the Year Ended December 31,
−Removed: – net loss attributable to Harrow Health, Inc.
+Added: For the Years Ended December 31,
+Added: Numerator – net loss attributable to Harrow Health, Inc.
common stockholders
−Removed: – weighted average number of shares outstanding, basic and diluted
−Removed: loss per share, basic and diluted
−Removed: Adopted Accounting Pronouncements
−Removed: December 2019, the FASB issued ASU 2019-12, Income Taxes:
−Removed: Simplifying the Accounting for Income Taxes , which simplifies the accounting
−Removed: for income taxes.
−Removed: This guidance became effective for the Company on January 1, 2021 on a prospective basis.
−Removed: Adoption of this ASU did
−Removed: not have a material impact on the Company’s consolidated financial statements.
+Added: $ ( 14,086,000 )
+Added: $ ( 18,479,000 )
+Added: Denominator – weighted average number of shares outstanding, basic
+Added: Net loss per share, basic and diluted
+Added: Accounting Pronouncements Not Yet Adopted
+Added: June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments .
+Added: This ASU replaces the incurred
+Added: loss impairment methodology in current U.S.
+Added: GAAP with a methodology that reflects expected credit losses and requires consideration of
+Added: a broader range of reasonable and supportable information for credit loss estimates on certain types of financial instruments, including
+Added: trade receivables.
+Added: In addition, new disclosures are required.
+Added: The ASU, as subsequently amended, is effective for the Company for fiscal
+Added: years beginning after December 15, 2022, as the Company was a smaller reporting company as of November 15, 2019, the determination date.
+Added: The Company plans to adopt ASU 2016-13 on January 1, 2023 and has evaluated the effect that this guidance will have on its consolidated
+Added: financial statements.
+Added: Based on the composition of the Company’s accounts receivable and other financial assets, including current
+Added: market conditions and historical credit loss activity, the adoption of this standard is not expected to have a material impact on the
+Added: Company’s consolidated financial statements.
+Added: March 2022, the FASB issued ASU 2022-02, Financial Instruments-Credit Losses (Topic 326):
+Added: Troubled Debt Restructurings and Vintage
+Added: Disclosures , which addresses and amends areas identified by the FASB as part of its post-implementation review of the accounting
+Added: standard that introduced the current expected credit losses (“CECL”) model.
+Added: The amendments eliminate the accounting guidance
+Added: for troubled debt restructurings by creditors that have adopted the CECL model and enhance the disclosure requirements for loan refinancings
+Added: and restructurings made with borrowers experiencing financial difficulty.
+Added: In addition, the amendments require disclosure of current-period
+Added: gross write offs for financing receivables and net investment in leases by year of origination in the vintage disclosures.
+Added: For entities,
+Added: such as the Company, that have not yet adopted the CECL accounting model in ASU 2016-13, the effective date for the amendments in ASU
+Added: 2022-02 is the same as the effective date in ASU 2016-13 (i.e., fiscal years beginning after December 15, 2022 including interim periods
+Added: within those fiscal years).
+Added: The Company plans to adopt ASU 2022-02 on January 1, 2023.
+Added: The Company has evaluated the effect of this guidance
+Added: and does not expect it to have a material impact on its consolidated financial statements.
Reclassifications
4 unchanged sentences
Company accounts for contracts with customers in accordance with ASC 606, Revenues from Contracts with Customers .
−Removed: has two primary streams of revenue:
−Removed: (1) revenue recognized from our sale of products within our pharmacy services and (2) revenue recognized
−Removed: from intellectual property license and asset purchase agreements.
−Removed: Company sells prescription drugs directly through its pharmacy and outsourcing facility network.
−Removed: Revenue from our pharmacy services division
−Removed: (i) the portion of the price the client pays directly to us, net of any volume-related or other discounts paid back to the
−Removed: client, (ii) the price paid to us by individuals, and (iii) customer copayments made directly to the pharmacy network.
−Removed: Sales taxes are
−Removed: not included in revenue.
−Removed: Following the core principles of ASC 606, we have identified the following:
+Added: has three primary streams of revenue:
+Added: (1) revenue recognized from sales of products through its pharmacy and outsourcing facility and
+Added: sales of branded products to wholesalers through a third-party logistics (“3PL”) partner, (2) revenue recognized from a commission
+Added: agreement with a third party, and (3) revenue recognized from intellectual property licenses and asset purchase agreements.
+Added: Company sells prescription medications directly through its pharmacy, outsourcing facility and 3PL partner.
+Added: Revenue from the Company’s
+Added: pharmacy services includes:
+Added: (i) the portion of the price the client pays directly to the Company, net of any volume-related or other
+Added: discounts paid back to the client, (ii) the price paid to the Company by individuals, and (iii) customer copayments made directly to
+Added: the pharmacy network.
+Added: Sales taxes are not included in revenue.
+Added: Following the core principles of ASC 606, the Company has identified the
the contract(s) with a customer :
−Removed: A contract exists with a customer at the time the prescription or order is received by the Company.
+Added: A contract is deemed to exist when the customer places an order through receipt of a prescription,
+Added: via an online order or via receipt of a purchase order from a customer.
+Added: For branded products, orders are received through the Company’s
+Added: 3PL partner, and the customer takes title of the products via formal purchase orders placed and fulfilled.
the performance obligations in the contract :
−Removed: The order received contains the performance obligations to be met, in almost all cases
−Removed: the product the customer is wishing to receive.
−Removed: If we are unable to be meet the performance obligation the customer is notified.
+Added: Obligations for fulfillment of the Company’s contracts consist of delivering
+Added: the product to customers at their specified destination.
+Added: ASU 2016-10 was issued in April 2016 and amended ASC 606 for shipping and
+Added: handling activities as follows:
+Added: If the customer takes control of the goods after shipment, shipping and handling activities would
+Added: always be considered a fulfillment activity and not treated as a separate performance obligation.
+Added: If the customer takes control of
+Added: the goods before shipment, entities must make an accounting policy election to treat shipping and handling activities as either a
+Added: fulfillment cost or as a separate performance obligation.
+Added: The Company has elected to treat its shipping and handling activities as
+Added: a fulfillment cost.
the transaction price :
−Removed: the transaction price is based on the product being sold to the customer, and any related customer discounts.
−Removed: These amounts are pre-determined and built into our order management software.
+Added: The transaction price is based on an amount that reflects the consideration to which the Company expects
+Added: to be entitled, net of accruals for estimated rebates, wholesaler chargebacks, discounts and other deductions (collectively, sales
+Added: deductions) and an estimate for returns and replacements established at the time of sale.
+Added: The Company utilizes the services of a
+Added: third-party professional services firm to estimate rebates and chargebacks associated with sales of its branded products.
+Added: of promised goods is satisfied within a year, and therefore there are no significant financing components.
+Added: There is no non-cash consideration
+Added: related to product sales.
the transaction price to the performance obligations in the contract :
−Removed: The transaction price associated with the product(s) being
−Removed: ordered is allocated according to the pre-determined amounts.
+Added: Given that there is only one performance obligation for
+Added: product sales, no allocation is necessary.
revenue when (or as) the entity satisfies a performance obligation :
−Removed: At the time of shipment from the pharmacy or outsourcing facility
−Removed: the performance obligation has been met.
−Removed: following revenue recognition policy has been established for the pharmacy services division:
−Removed: generated from prescription or office use drugs sold by our pharmacies and outsourcing facility are recognized when the prescription
−Removed: At the time of shipment, the pharmacy services division has performed substantially all of its obligations under its client
−Removed: contracts and does not experience a significant level of returns or reshipments.
−Removed: Determination of criteria (3) and (4) is based on management’s
−Removed: judgments regarding the fixed nature of the selling prices of the products delivered and the collectability of those amounts.
−Removed: records reductions to revenue for discounts at the time of the initial sale.
−Removed: Estimated returns and allowances and other adjustments are
−Removed: provided for in the same period during which the related sales are recorded and are based on actual returns history.
−Removed: The rate of returns
−Removed: is analyzed annually to determine historical returns experience.
−Removed: If the historical data we use to calculate these estimates do not properly
−Removed: reflect future returns, then a change in the allowance would be made in the period in which such a determination is made and revenues
−Removed: in that period could be materially affected.
−Removed: The Company will defer any revenues received for a product that has not been delivered or
−Removed: is subject to refund until such time that the Company and the customer jointly determine that the product has been delivered and no refund
−Removed: will be required.
−Removed: the year ended December 31, 2020, the Company entered into an agreement whereby it is paid a fee calculated based on sales the Company
−Removed: generates from a pharmaceutical product that is owned by a third party.
−Removed: The revenue earned from this arrangement is recognized at the
−Removed: time a customer has ordered the pharmaceutical product and it has shipped from the third party (or one of its distributors or affiliates),
−Removed: at which point there is no future performance obligation required by the Company and no consequential continuing involvement on the Company’s
+Added: Revenue from products is recognized upon transfer of control
+Added: of a product to a customer.
+Added: This generally occurs upon shipment unless contractual terms with a customer state that transfer of control
+Added: occurs at delivery.
+Added: Company has entered into an agreement whereby it is paid a fee calculated based on sales the Company generates from a pharmaceutical
+Added: product that is owned by a third party.
+Added: The revenue earned from this arrangement is recognized, at which point there is no future performance
+Added: obligation required by the Company and no consequential continuing involvement on the Company’s part to recognize the associated
+Added: From Transfer of Acquired Product Profit
+Added: Company entered into an agreement whereby it purchased the exclusive commercial rights to
+Added: assets associated with certain ophthalmic products from another pharmaceutical company (the “Seller”).
+Added: During a temporary,
+Added: six month transition period, the Seller continued to manufacture and market these products and transfer the net profit from
+Added: the sale of the products to the Company.
+Added: The revenue recognized by the Company from the transfer of net profit was recognized at the
+Added: time profit from the product sales was calculated by the Seller and confirmed by the Company, typically on a monthly basis, at which
+Added: point there is no future performance obligation required by the Company and no consequential continuing involvement on the Company’s
part to recognize the associated revenue.
−Removed: of Profit Revenues
−Removed: the year ended December 31, 2021, the Company entered into an agreement to purchase the exclusive
−Removed: commercial rights to assets associated with certain ophthalmic products from another pharmaceutical company (the “Seller”).
−Removed: During a temporary, six month transition period, the Seller will continue to manufacture and market these products and transfer
−Removed: the net profit from the sale of the products to the Company.
−Removed: The revenue recognized by the Company from the transfer of net profit is
−Removed: recognized at the time profit from the products sales has been calculated by the Seller and confirmed by the Company, typically on a
−Removed: monthly basis, at which point there is no future performance obligation required by the Company and no consequential continuing involvement
−Removed: on the Company in part to recognize the associated revenue.
+Added: On a quarterly basis, the Seller invoiced the Company for all credits and reimbursements (“Chargebacks”)
+Added: made to customers related to the products.
+Added: The Company used historical actual experience to estimate Chargebacks associated with the
+Added: net profit transferred.
+Added: The estimate is recorded as a reduction in revenues in the Company’s consolidated statements of operations
+Added: and accounts receivable in the consolidated balance sheets at the time the revenue is recognized.
Property License Revenues
−Removed: Company currently holds five intellectual property license and related agreements in which the Company has promised to grant a license
−Removed: or sale which provides a customer with the right to access the Company’s intellectual property.
−Removed: License arrangements may consist
−Removed: of non-refundable upfront license fees, data transfer fees, research reimbursement payments, exclusive license rights to patented or
−Removed: patent pending compounds, technology access fees, and various performance or sales milestones.
−Removed: These arrangements can be multiple-element
−Removed: arrangements, the revenue of which is recognized at the point of time the performance obligation is met.
+Added: Company currently holds five intellectual property licenses and related agreements pursuant to which the Company has agreed to license
+Added: or sell to a customer with the right to access the Company’s intellectual property.
+Added: License arrangements may consist of non-refundable
+Added: upfront license fees, data transfer fees, research reimbursement payments, exclusive license rights to patented or patent pending compounds,
+Added: technology access fees, and various performance or sales milestones.
+Added: These arrangements can be multiple-element arrangements, the revenue
+Added: of which is recognized at the point in time that the performance obligation is met.
Non-refundable
15 unchanged sentences
disaggregated by revenue source for the years ended December 31, 2022 and 2021, consists of the following:
−Removed: OF DISAGGREGATED REVENUE
−Removed: the Year Ended December 31,
+Added: SCHEDULE OF DISAGGREGATED REVENUE
+Added: For the Years Ended December 31,
+Added: Product sales, net
+Added: Transfer of profit
+Added: Total revenues
revenue and customer deposits at December 31, 2022 and 2021, were $ 113,000 and $ 16,000 , respectively.
−Removed: All deferred revenue and customer deposit
−Removed: amounts at December 31, 2020 were recognized as revenue during the year ended December 31, 2021.
+Added: All deferred revenue and customer
+Added: deposit amounts at December 31, 2021 were recognized as revenue during the year ended December 31, 2022.
+Added: RECENT PRODUCT ACQUISITIONS, LICENSES AND DIVESTITURES
+Added: of ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE
+Added: December 2022, the Company entered into an Asset Purchase Agreement (the “Fab 5 APA”) with Novartis Technology, LLC and Novartis
+Added: Innovative Therapies AG (together, “Novartis”), pursuant to which the Company agreed to purchase from Novartis the exclusive
+Added: commercial rights to assets associated with the following ophthalmic products (collectively the “Fab 5 Products”) in the
+Added: (the “Fab 5 Acquisition”):
+Added: ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE.
+Added: Subsequent to December 31, 2022, the Company
+Added: closed the Fab 5 Acquisition in January 2023 (see Note 20).
+Added: the terms of the Fab 5 APA, the Company made a one-time payment of $ 130,000,000 at closing in January 2023, with up to another $ 45,000,000
+Added: due in a milestone payment related to the timing of the commercial availability of TRIESENCE.
+Added: Pursuant to the Fab 5 APA and various ancillary
+Added: agreements, immediately following the closing and subject to certain conditions, for a period that the Company expects to last approximately
+Added: six months, and prior to the transfer of the Fab 5 Products new drug applications (the “NDAs”) to the Company, Novartis will
+Added: continue to sell the Fab 5 Products on the Company’s behalf and transfer the net profit from the sale of the Fab 5 Products to
+Added: Novartis has agreed to supply certain Fab 5 Products to the Company for a period of time after the NDAs are transferred
+Added: and to assist with technology transfer of the Fab 5 Products manufacturing to other third-party manufacturers, if needed.
+Added: of Non-Ophthalmic Assets
+Added: October 2022, wholly-owned subsidiaries of the Company (“Imprimis”) entered into an Asset Purchase Agreement (the “RPC
+Added: Agreement”) with Innovation Compounding Pharmacy, LLC (the “Buyer”).
+Added: Under the terms of the RPC Agreement, Imprimis
+Added: agreed to sell substantially all of its assets associated with its non-ophthalmology related compounding product line, including but
+Added: not limited to, certain intellectual property rights, customer lists, databases, and formulations (the “RPC Assets”).
+Added: Buyer agreed to make offers of employment to six of the Company’s employees that were responsible for the sales activities associated
+Added: with the RPC Assets.
+Added: Under the terms of the RPC Agreement, the Buyer paid Imprimis an aggregate cash amount of $ 6,000,000 in October
+Added: In addition, the Buyer is obligated to pay up to $ 4,500,000 to Imprimis based on mutually agreed upon revenue milestones during
+Added: the calendar year 2023 (the “Contingent Amount”).
+Added: During the year ended December 31, 2022, no amount related to the Contingent
+Added: Amount was recognized by the Company.
+Added: The Company will recognize a gain related to the Contingent Amount if/when the contingency (in
+Added: this case, revenue thresholds for 2023) become likely and reasonably estimated.
+Added: connection with the RPC Agreement, Imprimis entered into a separate transition services agreement with the Buyer related to providing
+Added: on going services associated with the RPC Assets, such as procuring and dispensing prescription orders, providing accounting and billing
+Added: services and collecting accounts receivable.
+Added: The Company expects Imprimis to provide transition services to the Buyer for up to six to
+Added: nine months following the effective date of the RPC Agreement.
+Added: The Company collected and will continue to collect cash on behalf of the
+Added: Buyer for revenue generated by sales of RPC Assets from October 2022 through the transition period and the Company is obligated to transfer
+Added: cash generated by such sales to the Buyer.
+Added: The Company’s consolidated balance sheet as of December 31, 2022 reflected $ 579,000
+Added: of cash collected on behalf of the Buyer and a receivable within accounts receivable of $ 128,000 for cash to be collected on behalf of
+Added: the Buyer for sales of RPC Assets sold through December 31, 2022.
+Added: amount due from the Buyer for reimbursement of services performed under the transition services agreement was $ 254,000 as of December 31, 2022.
+Added: Such amount was netted
+Added: against the amounts collected on behalf of the Buyer and was unpaid within accrued expenses on the consolidated balance sheet as of
+Added: December 31, 2022.
+Added: The combined total of $ 453,000 was recorded within accrued expenses on the consolidated balance sheet as of December
+Added: 31, 2022 and represents a payable to the Buyer.
+Added: The Company recorded income from the transition services agreement of $ 102,000 which
+Added: is presented in other income on the consolidated statement of operations for the year ended December 31, 2022.
+Added: Company determined that the disposal of the related net assets does not qualify for reporting as discontinued operations because it does
+Added: not represent a strategic shift that has or will have a major effect on the Company’s operations and financial results.
+Added: the year ended December 31, 2022, the Company recognized a net gain on the sale of the non-ophthalmology related compounding assets as
+Added: OF NET GAIN ON SALE OF ASSETS
+Added: Gross consideration
+Added: Closing and transaction costs
+Added: Book value of assets transferred:
+Added: Customer relations intangible asset
+Added: Gain on sale of non-ophthalmology assets
+Added: of IOPIDINE, MAXITROL and MOXEZA
+Added: December 2021, the Company entered into an Asset Purchase Agreement (the “NVS Agreement”) with Novartis Technology, LLC and
+Added: Novartis Ophthalmics AG (together, “NVS”), pursuant to which the Company purchased from NVS the exclusive commercial rights,
+Added: including the NDAs, to assets associated with ophthalmic products Moxeza, Iopidine 1% and 0.5%, and Maxitrol eyedrops suspension (collectively
+Added: the “NVS Products”) in the United States of America (“U.S.”) .
+Added: The Company made a one-time payment of $ 14,050,000
+Added: to NVS for the U.S.
+Added: rights to the NVS Products and their related intellectual property.
+Added: to the NVS Agreement and various ancillary agreements, immediately following the Closing
+Added: Date and subject to certain conditions, for a period of up to six months, and prior to the transfer of the NVS
+Added: Products NDAs (the “ NVS NDAs”) to the Company, NVS sold the NVS
+Added: Products on the Company’s behalf and transferred the net profit from the sale of the NVS
+Added: Products to the Company.
+Added: NVS has agreed to supply certain NVS Products to the Company
+Added: for a period of time after the NVS NDAs are transferred to the Company and to assist with
+Added: technology transfer of the NVS Products manufacturing to other third-party manufacturers,
+Added: Company accounted for this transaction as an asset acquisition, as the Company only acquired the rights and related intellectual property
+Added: for the NVS Products and the cost was allocated to the acquired patents and NDAs based on their relative fair values.
+Added: and Supply Agreement for IHEEZO
+Added: July 2021, the Company entered into a License and Supply Agreement (the “Sintetica Agreement”) with Sintetica S.A.
+Added: (“Sintetica”),
+Added: pursuant to which Sintetica granted the Company the exclusive license and marketing rights to its patented ophthalmic drug candidate
+Added: (“IHEEZO”) in the U.S.
+Added: to the Sintetica Agreement, the Company agreed to pay Sintetica a per unit transfer price to supply IHEEZO, along with a per unit royalty
+Added: for units sold.
+Added: The Company is required to pay Sintetica up to $ 18,000,000 in one-time milestone payments including a $ 5,000,000 payment
+Added: (the “Upfront Payment”) due within 30 days of signing the Sintetica Agreement and the balance of payments due upon achievement
+Added: of certain regulatory and commercial milestones.
+Added: Under the terms of the Sintetica Agreement, Sintetica is responsible for regulatory
+Added: filings for IHEEZO in the U.S.
+Added: The Upfront Payment along with an additional milestone payment of $ 3,117,000 was paid and recorded
+Added: as R&D expenses during the year ended December 31, 2021.
+Added: During the year ended December 31, 2022, $ 10,000,000 was paid or accrued
+Added: under the Sintetica Agreement following the FDA approval of the United States NDA for IHEEZO, and was capitalized as an intangible asset.
+Added: to certain limitations, the Sintetica Agreement has a ten-year term, and allows for a ten-year extension if certain sales thresholds
+Added: and Purchase of MAQ-100
+Added: August 2021, the Company entered into a License Agreement and a Basic Sale and Purchase Agreement (together, the “Wakamoto Agreements”)
+Added: with Wakamoto Pharmaceutical Co., Ltd.
+Added: (“Wakamoto”), pursuant to which Wakamoto granted the Company the exclusive license
+Added: and marketing rights to its ophthalmic drug candidate (“MAQ-100”) in the U.S.
+Added: to the Wakamoto Agreements, Wakamoto will supply MAQ-100 to the Company, and the
+Added: Company will pay Wakamoto a per unit transfer price to supply MAQ-100.
+Added: In addition, the Company is required to pay Wakamoto various one-time
+Added: milestone payments totaling up to $ 2,000,000 upon the achievement of certain regulatory milestones and up to $ 6,200,000 upon
+Added: the achievement of certain commercial milestones.
+Added: Under the terms of the Agreements, the Company will be responsible for regulatory filings
+Added: and fees for MAQ-100 in the U.S.
+Added: Through December 31, 2022, no amounts have been paid or accrued under the Wakamoto agreement.
+Added: to certain limitations, the term of the Wakamoto Agreements is for five years from the date of the FDA’s market approval of MAQ-100
+Added: and allows for a five-year extension if certain unit sales thresholds are met.
INVESTMENT IN MELT PHARMACEUTICALS, INC.
6 unchanged sentences
payments to the Company on net sales of the Melt Products while any patent rights remain outstanding, as well as other conditions.
−Removed: January and March 2019, the Company entered into the Melt Series A Preferred Stock Agreement, see also Note 2, under the subheading Investment
−Removed: in Melt Pharmaceuticals, Inc .
−Removed: February 2019, the Company and Melt entered into the Melt MSA, whereby the Company provides to Melt certain administrative services and
−Removed: support, including bookkeeping, web services and human resources related activities, and Melt is required to pay the Company a monthly
−Removed: amount of $ 10 .
−Removed: As of December 31, 2021 and 2020, the Company was due $ 48
−Removed: respectively, from Melt for reimbursable expenses and amounts due under the Melt MSA.
−Removed: Melt did not make any payments to the Company during
−Removed: the year ended December 31, 2021.
−Removed: The Company’s Chief Executive Officer, Mark L.
−Removed: Baum, was previously a member of the Melt board
−Removed: of directors until his resignation in November 2021.
+Added: February 2019, the Company and Melt entered into a Management Service Agreement between the Company and Melt (the “Melt MSA”),
+Added: whereby the Company provides to Melt certain administrative services and support, including bookkeeping, web services and human resources
+Added: related activities, and Melt is required to pay the Company a monthly amount of $ 10,000 .
+Added: the year ended December 31, 2022, the Company recorded $ 91,000 due from Melt for reimbursable expenses and amounts payable pursuant to
+Added: the Melt MSA, which are included in prepaid expenses and other current assets in the accompanying condensed consolidated balance sheets.
+Added: of December 31, 2022 and December 31, 2021, the Company was due $ 139,000 and $ 48,000 , respectively, from Melt for reimbursable expenses
+Added: and amounts due under the Melt MSA.
+Added: Melt did not make any payments to the Company during the year ended December 31, 2022.
+Added: Company’s Chief Executive Officer, Mark L.
+Added: Baum, was previously a member of the Melt board of directors until his resignation
+Added: during the year ended December 31, 2021.
Following Mr.
−Removed: Baum’s departure, the Company no longer has any representation
−Removed: on Melt’s board of directors.
+Added: Baum’s departure, the Company did not have any representation on
+Added: Melt’s board of directors until January 2023, when Mr.
+Added: Baum re-joined the Melt
+Added: board of directors.
+Added: At the time Mr.
+Added: Baum re-joined, the Melt board of directors consists of five total board members, including Mr.
+Added: Baum, who is the only representative of the Company on Melt’s board of directors.
unaudited condensed results of operations information of Melt is summarized below:
OF CONDENSED INCOME STATEMENT
−Removed: the Year Ended December 31,
−Removed: from operations
+Added: For the Years Ended December 31,
+Added: Revenues, net
+Added: Loss from operations
+Added: $ ( 14,446,000 )
+Added: $ ( 6,655,000 )
unaudited condensed balance sheet information of Melt is summarized below:
OF CONDENSED BALANCE SHEET
−Removed: preferred stock and stockholders’ (deficit) equity
−Removed: liabilities and stockholders’ equity
+Added: Current assets
+Added: Non-current assets
+Added: Total liabilities
+Added: Total preferred stock and stockholders’ deficit
+Added: ( 18,294,000 )
+Added: ( 4,454,000 )
+Added: Total liabilities and stockholders’ equity
Note Receivable
−Removed: September 2021, the Company entered into a loan and security agreement in the principal amount of $ 13,500 (the “Melt Loan Agreement”),
−Removed: as lender, with Melt, as borrower.
−Removed: Amounts borrowed under the Melt Loan Agreement bear interest at twelve and one-half percent ( 12.50 %)
+Added: September 1, 2021, the Company entered into a loan and security agreement in the principal amount of $ 13,500,000 (the “Melt
+Added: Loan Agreement”), as lender, with Melt, as borrower.
+Added: Amounts borrowed under the Melt Loan Agreement bear interest at 12.50 %
per annum, which interest can be paid in-kind at the option of Melt until the maturity date.
The Melt Loan Agreement permits Melt to
−Removed: pay interest only on the principal amount loaned thereunder through the term and all amounts owed will be due and payable on September
−Removed: Melt may elect to prepay all, but not less than all, of the amounts owed prior to the maturity date at any time without penalty.
+Added: pay interest only on the principal amount loaned thereunder through the term and all amounts owed were previously due and payable on
+Added: September 1, 2022.
+Added: In April 2022, the Company entered into a First Amendment and in September 2022, a Second Amendment (together, the
+Added: “Amendments”) to the Melt Loan Agreement.
+Added: The Amendments (i) extended the maturity date of the Melt Loan Agreement to June
+Added: 1, 2023, which can be extended further to September 1, 2026 upon Melt completing a qualifying financing of a minimum amount of $ 10,000,000 from
+Added: third-party investors, (ii) added conditions related to minimum cash amounts following a qualifying financing, and (iii) clarified the
+Added: definition of material adverse effects.
+Added: Melt may elect to prepay all, but not less than all, of the amounts owed prior to the maturity
+Added: date at any time without penalty.
has granted the Company a security interest in substantially all of its personal property, rights and assets, including intellectual
6 unchanged sentences
owed by Melt thereunder may be declared immediately due and payable by the Company, and the interest rate on the loan may be increased
−Removed: by three percent ( 3 %) per annum.
+Added: by 3 % per annum.
connection with the Melt Loan Agreement, the Company and Melt entered into a Right of First Refusal Agreement providing the Company with
1 unchanged sentence
candidates for a period of five years following the effective date of the Melt Loan Agreement.
−Removed: net funds received by Melt excluded $ 908 for amounts owed to the Company for reimbursable expenses and amounts due under the Melt MSA
−Removed: prior to the effective date of the note receivable (see Note 2).
+Added: net funds received by Melt excluded $ 908,000 owed to the Company for reimbursable expenses and amounts due under the Melt MSA prior
+Added: to the effective date of the note receivable.
+Added: As of December 31, 2022 and 2021, aggregate principal and accrued interest payable to the
+Added: Company pursuant to the Melt Loan Agreement amounted to $ 15,984,000 and $ 14,076,000 , respectively.
+Added: In accordance with ASC 328, Investments
+Added: – Equity Method and Joint Ventures , the carrying amount of the notes receivable has been reduced by the Company’s allocated
+Added: share of Melt’s losses based on its ownership of total debt owed by Melt (see Note 2).
INVESTMENT IN SURFACE OPHTHALMICS, INC.
5 unchanged sentences
is required to make mid-single digit royalty payments to the Company on net sales of the Surface Products while any patent rights remain
−Removed: of December 31, 2021, the Company owned 3,500,000 shares of Surface common stock (approximately 30 % of the issued and outstanding equity
−Removed: A Company director, Richard L.
−Removed: Lindstrom, and the Company’s Chief Executive Officer, Mark L.
−Removed: Baum, are directors of
−Removed: Lindstrom is a principal of Flying L Partners, an affiliate of a funding investor who purchased the Surface Series A Preferred
+Added: of December 31, 2022, the Company owned 3,500,000 shares of Surface common stock.
+Added: Company directors Richard L.
+Added: Lindstrom, Perry
+Added: Sternberg and Mark L.
+Added: Baum, who is also the Company’s Chief Executive Officer, are directors of Surface.
+Added: Lindstrom is a
+Added: principal of Flying L Partners, an affiliate of an investor who purchased Surface Series A Preferred Stock.
unaudited condensed results of operations information of Surface is summarized below:
OF CONDENSED INCOME STATEMENT
−Removed: the Years Ended December 31,
−Removed: from operations
+Added: For the Years Ended December 31,
+Added: Revenues, net
+Added: Loss from operations
+Added: $ ( 6,719,000 )
+Added: $ ( 6,579,000 )
+Added: $ ( 10,143,000 )
unaudited condensed balance sheet information of Surface is summarized below:
OF CONDENSED BALANCE SHEET
−Removed: stockholders’ equity
−Removed: liabilities and stockholders’ equity
−Removed: RESTRICTED CASH
−Removed: restricted cash at December 31, 2020 consisted of funds in a money market account and held as collateral for additional security for
−Removed: the Company’s New Jersey facility lease.
−Removed: All restrictions on this cash were released during the year ended December 31, 2021.
−Removed: December 31, 2020, the restricted cash was recorded at amortized cost, which approximates fair value.
+Added: Current assets
+Added: Non-current assets
+Added: Total liabilities
+Added: Total stockholders’ equity
+Added: Total liabilities and stockholders’ equity
are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, commercial pharmaceutical
3 unchanged sentences
OF INVENTORIES
+Added: Raw materials
+Added: Work in progress
+Added: Finished goods
+Added: Total inventories
PREPAID EXPENSES AND OTHER CURRENT ASSETS
expenses and other current assets consisted of the following:
−Removed: SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
−Removed: prepaid expenses
−Removed: due from Melt
−Removed: and other current assets
−Removed: prepaid expenses and other current assets
+Added: OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
+Added: Prepaid insurance
+Added: Prepaid computer software related expenses
+Added: Other prepaid expenses
+Added: Receivable due from Melt
+Added: Deposits and other current assets
+Added: Total prepaid expenses and other current assets
PROPERTY, PLANT AND EQUIPMENT
plant and equipment, net at December 31, 2022 and 2021 consisted of the following:
−Removed: SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT
−Removed: plant and equipment, net:
−Removed: and equipment
−Removed: and pharmacy equipment
−Removed: plant and equipment, gross
−Removed: depreciation and amortization
+Added: OF PROPERTY,PLANT AND EQUIPMENT
+Added: Property, plant and equipment, net:
+Added: Computer hardware
+Added: Furniture and equipment
+Added: Lab and pharmacy equipment
+Added: Leasehold improvements
+Added: Property, plant and equipment,
+Added: Accumulated depreciation and amortization
+Added: ( 9,061,000 )
+Added: ( 7,833,000 )
plant and equipment, net
−Removed: the years ended December 31, 2021 and 2020, the Company disposed of property, plant and equipment with a net book value of $ 41
−Removed: and a write down of equipment of
−Removed: $ 150 and $ 105 ,
−Removed: respectively, related to the discontinued use of certain lab equipment and computer software and hardware and is included in other expense,
−Removed: net in of the consolidated statements of operations.
−Removed: The Company purchased $ 753 of lab and pharmacy equipment from Eton during the
−Removed: year ended December 31, 2021.
−Removed: The Company recorded depreciation and amortization expense of $ 1,580
−Removed: during the years ended December 31, 2021 and
+Added: the years ended December 31, 2022 and 2021, the Company disposed of property, plant and equipment with a net book value of $ 99,000 and
+Added: $ 41,000 , respectively, and during the year ended December 31, 2021 the Company recorded an impairment charge of $ 150,000 related to the
+Added: discontinued use of certain lab equipment, which is included in other expense, net in the consolidated statements of operations.
+Added: Company recorded depreciation and amortization expense of $ 1,253,000 and $ 1,580,000 during the years ended December 31, 2022 and 2021,
respectively.
−Removed: CAPITALIZED SOFTWARE DEVELOPMENT COSTS
−Removed: software development costs at December 31, 2021 and 2020 consisted of the following:
+Added: the year ended December 31, 2021, the Company purchased lab and pharmacy equipment at a cost of $ 753,000 from Eton.
+Added: CAPITALIZED SOFTWARE COSTS
+Added: software costs at December 31, 2022 and 2021 consisted of the following:
OF FINITE LIVED INTANGIBLE ASSETS
−Removed: internal-use software development costs
−Removed: third-party software license for internal-use
−Removed: gross capitalized software for internal-use
−Removed: internal-use software in process
−Removed: finite lived intangible assets net
−Removed: Company recorded amortization expense of $ 137
−Removed: related to capitalized software development
−Removed: costs during the years ended December 31, 2021 and
−Removed: 2020, respectively.
+Added: Capitalized software costs
+Added: Capitalized internal-use software development costs
+Added: Acquired third-party software license for internal-use
+Added: Total gross capitalized software for internal-use
+Added: Accumulated amortization
+Added: Capitalized internal-use software in process
+Added: Total finite lived intangible
+Added: Company recorded amortization expense of $ 224,000 and $ 137,000 during the years ended December 31, 2022 and 2021, respectively.
INTANGIBLE ASSETS AND GOODWILL
Company’s intangible assets at December 31, 2022 consisted of the following:
−Removed: SCHEDULE OF INTANGIBLE ASSETS
−Removed: relationships
−Removed: Non-competition
−Removed: pharmacy licenses
+Added: OF INTANGIBLE ASSETS
+Added: 7 - 19 years Indefinite
+Added: $ ( 161,000 )
+Added: Acquired NDAs
+Added: ( 1,363,000 )
+Added: Customer relationships
+Added: Non-competition clause
+Added: State pharmacy licenses
+Added: $ ( 2,368,000 )
+Added: $ ( 626,000 )
+Added: the year ended December 31, 2022, the Company recorded a net reduction to customer relationships intangible assets of $ 626,000
+Added: related to customer relationships that were associated with the non-ophthalmology assets sold by the Company.
+Added: The amount was
+Added: reflected net of the gross proceeds received related to the sale of the Company’s non-ophthalmology assets (see Note
+Added: Company’s intangible assets at December 31, 2021 consisted of the following:
+Added: Acquired NDAs
+Added: Customer relationships
+Added: Non-competition clause
+Added: State pharmacy licenses
+Added: $ ( 730,000 )
the year ended December 31, 2021, the Company recorded impairment charges of $ 99,000 related to patent filings and trademarks that were
abandoned and/or were associated with products the Company was no longer actively selling.
−Removed: the year ended December 31, 2021, the Company entered into an Asset Purchase Agreement (the “NVS Agreement”) with
−Removed: Novartis Technology, LLC and Novartis Ophthalmics AG (together, “NVS”), pursuant to which the Company purchased from NVS
−Removed: exclusive commercial rights, including the New Drug Applications (“NDAs”), to assets associated with ophthalmic products
−Removed: Moxeza, Iopidine 1% and 0.5%, and Maxitrol eyedrops suspension (collectively the “ NVS Products”) in the United States of
−Removed: America(“U.S.”).
−Removed: The Company made a one-time payment of $ 14,050
−Removed: to NVS for the U.S.
−Removed: rights to the NVS Products and their related intellectual property.
−Removed: The Company accounted for this transaction as an asset acquisition,
−Removed: as the Company only acquired the rights and related intellectual property for the NVS Products and the cost was allocated to the
−Removed: acquired patents and NDAs based on their relative fair values.
−Removed: The Company’s intangible assets at December
−Removed: 31, 2021 consisted of the following:
−Removed: relationships
−Removed: Non-competition
−Removed: pharmacy licenses
−Removed: the year ended December 31, 2021, the Company recorded impairment charges of $ 99 related to trademarks that were abandoned and/or were
−Removed: associated with products the Company was no longer actively selling.
+Added: Note 4 related to intangible assets acquired and divested during the years ended December 31, 2022 and 2021.
expense for intangible assets for the years ended December 31, 2022 and 2021 were as follows:
−Removed: SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
−Removed: the Year Ended December 31,
−Removed: relationships
−Removed: of intangible assets
+Added: OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
+Added: For the Years Ended December 31,
+Added: Acquired NDAs
+Added: Customer relationships
+Added: Amortization of intangible
future amortization expense for the Company’s intangible assets at December 31, 2022 is as follows:
−Removed: SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE
−Removed: ending December 31,
+Added: OF ESTIMATED FUTURE AMORTIZATION EXPENSE
+Added: Years ending December 31,
+Added: Intangible assets
were no changes in the carrying value of the Company’s goodwill during the years ended December 31, 2022 and 2021.
1 unchanged sentence
payable and accrued expenses at December 31, 2022 and 2021 consisted of the following:
−Removed: SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
−Removed: accrued expenses
−Removed: interest (see Note 13)
−Removed: exit fee for note payable (see Note 13)
−Removed: accounts payable and accrued expenses
−Removed: Current portion
−Removed: total accrued expenses
+Added: OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
+Added: Accounts payable
+Added: Accrued insurance premium
+Added: Accrued IHEEZO milestone payments (see Note 4)
+Added: Accrued RPC transition payments (see Note 4)
+Added: Accrued litigation settlements
+Added: Accrued interest (see Note 13)
+Added: Total accounts payable and accrued expenses
+Added: Note 20 related to debt transactions that occurred subsequent to December 31, 2022.
Senior Notes Due 2027
−Removed: April 2021, the Company closed an offering of $ 50,000 aggregate principal amount of 8.625% senior notes due in April 2026, and in May
−Removed: 2021 issued an additional $ 5,000 of such notes pursuant to the full exercise of the underwriters’ option to purchase additional
−Removed: notes (collectively, the “April Notes”).
−Removed: The April Notes were sold to investors at a par value of $ 25.00 per April Note and
−Removed: the offering resulted in net proceeds to the Company of approximately $ 51,909 after deducting underwriting discounts and commissions
−Removed: and expenses of $ 3,091 .
−Removed: In June 2021, in a further issuance of the April Notes, the Company sold an additional $ 20,000 aggregate principal
−Removed: amount of such notes (the “June Notes,” and together with the April Notes, the “Notes”), at a price of $ 25.75
−Removed: per June Note, with interest of $ 278 on the June Notes being accrued from April 20, 2021 as of the date of issuance.
−Removed: The June offering
−Removed: resulted in net proceeds to the Company of approximately $ 19,164 after deducting underwriting discounts and commissions and expenses
−Removed: of $ 1,158 and a premium on note issuance of $ 322 .
−Removed: The June Notes are treated as a single series with the April Notes under the indenture
−Removed: governing the April Notes, dated as of April 20, 2021, and have the same terms as the April Notes (other than the initial offering price
−Removed: and issue date).
−Removed: T he Notes are senior unsecured obligations of the Company and rank equally
−Removed: in right of payment with all of our other existing and future senior unsecured and unsubordinated indebtedness.
−Removed: The Notes are effectively
−Removed: subordinated in right of payment to all of the Company’s existing and future secured indebtedness and structurally subordinated
−Removed: to all existing and future indebtedness of the Company’s subsidiaries, including trade payables.
−Removed: The Notes bear interest at a rate
−Removed: of 8.625 % per annum.
−Removed: Interest on the Notes is payable quarterly in arrears on January 31, April 30, July 31 and October 31 of each year,
−Removed: commencing on July 31, 2021.
−Removed: The Notes will mature on April 30, 2026.
−Removed: The issuance costs were recorded
−Removed: as a debt discount and are being amortized as interest expense, net of the amortization of the premium on note issuance, over the term
−Removed: of the Notes using the effective interest rate method.
−Removed: to February 1, 2026, the Company may, at its option, redeem the Notes, in whole at any time or in part from time to time, at a redemption
−Removed: price equal to 100% of the principal amount of the Notes to be redeemed , plus a make-whole amount, if any, plus accrued and unpaid interest
−Removed: to, but excluding, the date of redemption.
−Removed: The Company may redeem the Notes for cash in whole or in part at any time at our option on
−Removed: or after February 1, 2026 and prior to maturity, at a price equal to 100% of their principal amount, plus accrued and unpaid interest
+Added: December 2022, the Company closed an offering of $ 35,000,000 aggregate principal amount of 11.875% senior notes due in December 2027
+Added: (the “2027 Notes”).
+Added: The 2027 Notes were sold to investors at a par value of $ 25.00 per 2027 Note, and the offering resulted
+Added: in net proceeds to the Company of approximately $ 31,738,000 after deducting underwriting discounts and commissions and expenses
+Added: of $ 3,626,000 .
+Added: 2027 Notes are senior unsecured obligations of the Company and rank equally in right of payment with all of the Company’s other
+Added: existing and future senior unsecured and unsubordinated indebtedness.
+Added: The 2027 Notes are effectively subordinated in right of payment
+Added: to all of the Company’s existing and future secured indebtedness and structurally subordinated to all existing and future indebtedness
+Added: of the Company’s subsidiaries, including trade payables.
+Added: The 2027 Notes bear interest at the rate of 11.875 % per annum.
+Added: on the 2027 Notes is payable quarterly in arrears on January 31, April 30, July 31 and October 31 of each year, commencing on January
+Added: The 2027 Notes will mature on December 31, 2027 .
+Added: any time prior to December 31, 2024, the Company may, at its option, redeem the 2027 Notes, in whole at any time or in part from time
+Added: to time, at a redemption price equal to 100% of the principal amount of the 2027 Notes to be redeemed, plus a make-whole amount, if any,
+Added: plus accrued and unpaid interest to, but excluding, the date of redemption.
+Added: The Company may redeem the 2027 Notes for cash in whole or
+Added: in part at any time at its option (i) on or after December 31, 2024 and prior to December 31, 2025, at a price equal to $25.50 per note,
+Added: plus accrued and unpaid interest to, but excluding, the date of redemption, (ii) on or after December 31, 2025 and prior to December
+Added: 31, 2026, at a price equal to $25.25 per note, plus accrued and unpaid interest to, but excluding, the date of redemption, and (iii)
+Added: on or after December 31, 2026 and prior to maturity, at a price equal to 100% of their principal amount, plus accrued and unpaid interest
to, but excluding, the date of redemption.
−Removed: On and after any redemption date, interest will cease to accrue on the redeemed Notes.
−Removed: expense related to the Notes totaled $ 5,132 for the year ended December 31, 2021, and included amortization of debt issuance costs and
−Removed: discount of $ 581 for the year ended December 31, 2021.
+Added: In addition, the Company is required to redeem the 2027 Notes, for cash, in whole but not
+Added: in part, at the price of $25.50 per note , plus accrued and unpaid interest to, but excluding, the date of redemption, upon occurrence
+Added: of certain events including (i) a failure by the Company to complete the Fab 5 Acquisition), subject to certain exceptions, within 180
+Added: calendar days after December 20, 2022, or (ii) the occurrence of a Material Change, as defined in the Second Supplemental Indenture.
+Added: Senior Notes Due 2026
+Added: April 2021, the Company closed an offering of $ 50,000,000 aggregate principal amount of 8.625% senior notes due in April
+Added: 2026, and in May 2021 issued an additional $ 5,000,000 of such notes pursuant to the full exercise of the underwriters’ option
+Added: to purchase additional notes (collectively, the “April Notes”).
+Added: The April Notes were sold to investors at a par value of
+Added: $ 25.00 per April Note and the offering resulted in net proceeds to the Company of approximately $ 51,909,000 after deducting
+Added: underwriting discounts and commissions and expenses of $ 3,091,000 .
+Added: In June 2021, in a further issuance of the April Notes, the Company
+Added: sold an additional $ 20,000,000 aggregate principal amount of such notes (the “June Notes,” and together with the April
+Added: Notes, the “ 2026 Notes”), at a price of $ 25.75 per June Note, with interest of $ 278,000 on the June Notes being
+Added: accrued from April 20, 2021 as of the date of issuance.
+Added: The June offering resulted in net proceeds to the Company of approximately $ 19,164,000 after
+Added: deducting underwriting discounts and commissions and expenses of $ 1,158,000 and a premium on note issuance of $ 322,000 .
+Added: Notes are treated as a single series with the April Notes under the indenture governing the April Notes, dated as of April 20, 2021,
+Added: and have the same terms as the April Notes (other than the initial offering price and issue date).
+Added: 2026 Notes are senior unsecured obligations of the Company and rank equally in right of payment with all of our other existing and future
+Added: senior unsecured and unsubordinated indebtedness.
+Added: The 2026 Notes are effectively subordinated in right of payment to all of the Company’s
+Added: existing and future secured indebtedness and structurally subordinated to all existing and future indebtedness of the Company’s
+Added: subsidiaries, including trade payables.
+Added: The 2026 Notes bear interest at a rate of 8.625 % per annum.
+Added: Interest on the 2026 Notes
+Added: is payable quarterly in arrears on January 31, April 30, July 31 and October 31 of each year, commencing on July 31, 2021.
+Added: The 2026 Notes
+Added: will mature on April 30, 2026 .
+Added: The issuance costs were recorded as a debt discount and are
+Added: being amortized as interest expense, net of the amortization of the premium on note issuance, over the term of the 2026 Notes using the
+Added: effective interest rate method.
+Added: to February 1, 2026, the Company may, at its option, redeem the 2026 Notes, in whole at any time or in part from time to time, at a
+Added: redemption price equal to 100% of the principal amount of the 2026 Notes to be redeemed , plus a make-whole amount, if any, plus accrued
+Added: and unpaid interest to, but excluding, the date of redemption.
+Added: The Company may redeem the 2026 Notes for cash in whole or in part at
+Added: any time at our option on or after February 1, 2026 and prior to maturity, at a price equal to 100% of their principal amount, plus accrued
+Added: and unpaid interest to, but excluding, the date of redemption.
+Added: On and after any redemption date, interest will cease to accrue on the
+Added: redeemed 2026 Notes.
+Added: expense related to the 2026 Notes and 2027 Notes totaled $ 7,378,000 and $ 5,132,000 for the years ended December 31, 2022 and
+Added: 2021, respectively, and included amortization of debt issuance costs and discount of $ 782,000 , and $ 581,000 for the years ended
+Added: December 31, 2022 and 2021, respectively.
+Added: Riley Loan and Security Agreement
+Added: December 14, 2022 (the “Effective Date”), the Company entered into a Loan and Security Agreement (the “BR Loan”)
+Added: Riley Commercial Capital, LLC, as Administrative Agent for the Lenders.
+Added: The BR Loan provided for a loan facility of up to $ 100,000,000
+Added: to the Company with a maturity date of December 14, 2025 (the “Maturity Date”), at an interest rate of 10.875 % per annum.
+Added: BR Loan is secured by an intellectual property security agreement entered into in connection with the BR Loan, and by all assets of the
+Added: Company and its material subsidiaries.
+Added: The outstanding balance of the BR Loan is due in full on the Maturity Date.
+Added: The BR Loan provides
+Added: for voluntary prepayment subject to a prepayment fee of $ 0 if no Loan had been funded or the prepayment or repayment occurs (other than
+Added: as a result of acceleration of the BR Loan) on or prior to the date that is 90 days following the Effective Date and up to 3.00 % of the
+Added: amount of the Loan based on other payment dates.
+Added: BR Loan also provides for mandatory and customary prepayments, along with customary representations and warranties, covenants and events
+Added: The covenants set forth in the BR Loan included certain affirmative and negative operational and financial covenants, including,
+Added: among other things, restrictions on the Company’s ability to incur certain liens, make fundamental changes to its business or engage
+Added: in transactions with affiliates.
+Added: amounts were outstanding under the BR Loan as of December 31, 2022.
+Added: In January 2023, $ 59,750,000 of principal amount was funded pursuant
+Added: to the BR Loan simultaneously with the consummation of the Fab 5 Acquisition (see Note 20).
Senior Note – Paid in April 2021
July 2017, the Company and several of its wholly owned subsidiaries entered into a term loan and security agreement in the principal
−Removed: amount of $ 16,000 (the “SWK Loan Agreement” or “SWK Loan”) with SWK Funding LLC and its partners (collectively,
−Removed: “SWK”), as lender and collateral agent.
+Added: amount of $ 16,000,000 (the
+Added: “SWK Loan Agreement” or “SWK Loan”) with SWK Funding LLC and its partners (collectively, “SWK”),
+Added: as lender and collateral agent.
The SWK Loan Agreement was fully funded at closing with a five-year term;
−Removed: such term could be reduced to four years if certain revenue requirements were not achieved.
−Removed: The SWK Loan was secured by substantially
−Removed: all of the Company’s assets, including its intellectual property rights.
−Removed: The SWK Loan was subsequently amended in May 2019 and
−Removed: again in April 2020.
−Removed: The SWK Loan bore an interest rate equal to the three-month London Inter-Bank Offered Rate (subject to a minimum
−Removed: of 2.00 %), plus an applicable margin of 10.00 % (the “Margin Rate”);
−Removed: provided that, if, two days prior to a payment date,
−Removed: the Company provided SWK evidence that the Company has achieved a leverage ratio as of such date of less than 4.00:1:00, the Margin Rate
−Removed: shall equal 9.00%;
−Removed: and if the Company had achieved a leverage ratio as of such date of less than 3.00:1:00, the Margin Rate shall equal
−Removed: The leverage ratio means, as of any date of determination, the ratio of:
−Removed: (a) indebtedness as of such date to (b) EBITDA (as defined
−Removed: in the SWK Loan), of the Company for the immediately preceding 12 month period, adding-back (i) actual litigation expenses for the immediately
+Added: however, such term could be
+Added: reduced to four years if certain revenue requirements were not achieved.
+Added: The SWK Loan was secured by substantially all of the Company’s
+Added: assets, including its intellectual property rights.
+Added: The SWK Loan was subsequently amended in May 2019 and again in April 2020.
+Added: Loan bore an interest rate equal to the three-month London Inter-Bank Offered Rate (subject to a minimum of 2.00 % ),
+Added: plus an applicable margin of 10.00 % (the
+Added: “Margin Rate”);
+Added: provided that, if, two days prior to a payment date, the Company provided SWK evidence that the Company
+Added: has achieved a leverage ratio as of such date of less than 4.00:1:00, the Margin Rate shall equal 9.00%;
+Added: and if the Company had achieved
+Added: a leverage ratio as of such date of less than 3.00:1:00, the Margin Rate shall equal 7.00% .
+Added: leverage ratio means, as of any date of determination, the ratio of:
+Added: (a) indebtedness as of such date to (b) EBITDA (as defined in the
+Added: SWK Loan), of the Company for the immediately preceding 12 month period, adding-back (i) actual litigation expenses for the immediately
preceding 12 month period, minus (ii) actual litigation expenses for the immediately preceding 3 month period multiplied by 4.
3 unchanged sentences
amount loaned for the next payment (payments are due on a quarterly basis) following the SWK Second Amendment;
−Removed: 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
−Removed: to the interest accrued as of such date.
−Removed: expense related to the SWK Loan Agreement, as amended, amounted to $ 647 for the year ended December 31, 2021, and $ 1,767 for the year
−Removed: ended December 31, 2020, and included amortization of debt issuance costs and discounts of $ 96 for the year ended December 31, 2021,
−Removed: and $ 354 for the year ended December 31, 2020.
−Removed: April 2021, the Company paid $ 15,540 related to all outstanding obligations to SWK under the SWK Loan, including outstanding principal,
−Removed: accrued interest, accrued exit fee and related expenses and recorded a loss from early extinguishment of $ 756 related to the SWK Loan
−Removed: during the year ended December 31, 2021.
+Added: interest payment of $ 358,000 due May 14, 2020 was paid in-kind by increasing the principal amount of the term loans by an amount
+Added: equal to the interest accrued as of such date.
+Added: expense related to the SWK Loan Agreement, as amended, amounted to $ 647,000 for the year ended December 31, 2021, and included amortization
+Added: of debt issuance costs and discounts of $ 96,000 for the year ended December 31, 2021.
+Added: April 2021, the Company paid $ 15,540,000 related to all outstanding obligations to SWK under the SWK Loan, including outstanding
+Added: principal, accrued interest, accrued exit fee and related expenses and recorded a loss from early extinguishment of $ 756,000 related
+Added: to the SWK Loan during the year ended December 31, 2021.
Protection Program Loan – Forgiven in March 2021
April 2020, the Company entered into an unsecured promissory note and related Business Loan Agreement with Renasant Bank, as lender,
−Removed: for a loan (the “PPP Loan”) in the principal amount of $ 1,967 and received cash proceeds of the same amount, pursuant to
−Removed: the Paycheck Protection Program (the “PPP”) under the Federal Coronavirus Aid, Relief, and Economic Security Act (the “CARES
−Removed: Act”), which was enacted March 27, 2020.
+Added: for a loan (the “PPP Loan”) in the principal amount of $ 1,967,000 and received cash proceeds of the same amount, pursuant
+Added: to the Paycheck Protection Program (the “PPP”) under the Federal Coronavirus Aid, Relief, and Economic Security Act (the
+Added: “CARES Act”), which was enacted March 27, 2020.
The PPP is administered by the U.S.
4 unchanged sentences
of the PPP Loan for the loan balance of $ 1,967,000 in the accompanying consolidated statement of operations for the year ended December
−Removed: December 31, 2021, future minimum payments under the Company’s Notes were as follows:
−Removed: SUMMARY OF FUTURE MINIMUM PAYMENTS
−Removed: minimum payments
+Added: December 31, 2022, future minimum payments under the Company’s debt were as follows (excluding debt transactions that occurred
+Added: subsequent to December 31, 2022):
+Added: OF FUTURE MINIMUM PAYMENTS UNDER NOTES PAYABLES
+Added: Total minimum payments
amount representing interest payments
−Removed: payable, gross
+Added: ( 41,773,000 )
+Added: Notes payable, gross
unamortized discount, net of premium
−Removed: payable, net of unamortized discount
+Added: ( 5,826,000 )
+Added: Notes payable, net of unamortized discount
+Added: $ 104,174,000
Company leases office and laboratory space under the non-cancelable operating leases listed below.
These lease agreements have remaining
−Removed: lease terms between one to four years and contain various clauses for renewal at the Company’s option.
−Removed: operating lease for 10,200 square feet of office space in San Diego, California that expired
−Removed: in December 2021 ;
−Removed: operating lease for 5,789
−Removed: feet of office space in Carlsbad, California, which commenced in January 2022 and will expire
−Removed: in July 2027 .
−Removed: Since the commencement date of this lease occurred after December 31, 2021,
−Removed: right-of-use assets and operating lease liabilities associated with it are not included in
−Removed: our consolidated balance sheet at December 31, 2021 ;
−Removed: operating lease for 35,326 square feet of lab, warehouse and office space in Ledgewood, New
−Removed: Jersey that expires in July 2026 , with an option to extend the term for two additional five-year
−Removed: This includes an amendment that was made effective July 2020 that extended the term
−Removed: of the original lease and added 1,400 of additional square footage to the lease and another
−Removed: amendment entered into in May 2021 that extended the term of the lease to July 2027 and added
−Removed: 8,900 square feet of space;
−Removed: operating lease for 5,500 square feet of office space in Nashville, Tennessee, that expires
−Removed: in December 2024 , with an option to extend the term for two additional five-year periods .
−Removed: the year ended December 31, 2021, the Company terminated its operating lease for 10,200 square feet of office space in San Diego, California,
−Removed: that had an expiration date in December 2021 .
+Added: terms between one to five years and contain various clauses for renewal at the Company’s option.
+Added: operating lease for 5,789 square feet of office space in Carlsbad, California, which commenced in January 2022 that expires in March 2025, with an option to extend the term through March 2028 .
+Added: operating lease for 35,326 square feet of lab, warehouse and office space in Ledgewood, New Jersey that expires in July
+Added: 2026 , with an option to extend the term for two additional five-year periods.
+Added: This lease was amended, effective July 2020, to extend
+Added: the term of the original lease and add 1,400 of additional square footage to the lease, and amended again in May 2021 to
+Added: extend the term of the lease to July 2027 and add 8,900 square feet of space.
+Added: operating lease for 5,500 square feet of office space in Nashville, Tennessee that expires in December 2024 , with
+Added: an option to extend the term for two additional five-year periods.
+Added: operating lease for 11,552 square feet of lab and office space in Nashville, Tennessee which commenced in June 2022 and
+Added: expires in June 2027 .
December 31, 2022 and 2021, the weighted-average discount rate and the weighted-average remaining lease term for the operating leases
−Removed: held by the Company were 6.3 % and 6.3 % and 14.6 and 11.2 years, respectively.
+Added: held by the Company were 6.6 %
+Added: years, respectively.
the years ended December 31, 2022 and 2021, cash paid for amounts included for the operating lease liabilities was $ 925,000 and
−Removed: respectively, and the Company recorded operating lease expense of $ 912 and $ 1,066 , respectively, included in selling, general and administrative
+Added: $ 1,000,000 , respectively, and the Company recorded operating lease expense of $ 1,117,000 and $ 912,000 , respectively, included in
+Added: selling, general and administrative expenses.
lease payments under operating leases as of December 31, 2022 were as follows :
OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES
−Removed: minimum lease payments
+Added: Operating Leases
+Added: Total minimum lease payments
amount representing interest payments
−Removed: operating lease liabilities
+Added: ( 3,446,000 )
+Added: Total operating lease liabilities
current portion, operating lease liabilities
−Removed: lease liabilities, net of current portion
−Removed: Company has a finance lease for equipment which requires monthly payments of $ 1 through January 2024.
−Removed: lease payments under the finance lease as of December 31, 2021 were as follows :
−Removed: OF FUTURE LEASE PAYMENT UNDER FINANCE LEASE
−Removed: minimum lease payments
−Removed: amount representing interest payments
−Removed: value of future minimum lease payments
−Removed: current portion, finance lease obligation
−Removed: lease obligation, net of current portion
−Removed: December 31, 2021 and 2020, the weighted-average discount rate and the weighted-average remaining lease term for the finance lease held
−Removed: by the Company were 6.36 % and 6.36 % and 2.08 and 3.08 years, respectively.
−Removed: the years ended December 31, 2021 and 2020:
−Removed: ● amortization
−Removed: expense related to the equipment held under the finance lease obligations was $ 8 and $ 8 ,
−Removed: respectively;
−Removed: paid and expense recognized for interest expense related to the finance lease obligation
−Removed: was $ 1 and $ 2 , respectively.
+Added: Operating lease liabilities, net of current portion
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
−Removed: December 31, 2021 and 2020, the Company had 5,000,000 shares of preferred stock, $ 0.001 par value, authorized and no shares of preferred
−Removed: stock issued and outstanding.
+Added: December 31, 2022 and 2021, the Company had 5,000,000 shares of preferred stock, $ 0.001 par value, authorized and no shares
+Added: of preferred stock issued and outstanding.
B Cumulative Preferred Stock – Redeemed in June 2021
−Removed: May 2021, the Company sold 440,000 shares of the Company’s Series B Cumulative Preferred Stock, par value $ 0.001 per share and
−Removed: liquidation preference of $ 25.00 per share (the “Series B Preferred Stock”), for net proceeds of approximately $ 10,655 .
−Removed: Series B Preferred Stock was not convertible into our common stock, had no voting rights , except as required by Delaware law, and was
−Removed: redeemable by the Company at any time.
−Removed: Holders of Series B Preferred Stock were entitled to cumulative cash dividends at the rate of
−Removed: 9.50 % of the $ 25.00 liquidation preference per year;
−Removed: provided, however, that for each thirty (30) day period following May 5, 2021, the
−Removed: dividend rate increased at various rates, except as otherwise limited by applicable law.
−Removed: Dividends were payable quarterly in arrears,
−Removed: on or about the 15th of January, April, July and October, beginning on or about July 15, 2021.
+Added: May 2021, the Company sold 440,000 shares of the Company’s Series B Cumulative Preferred Stock, par value $ 0.001 per
+Added: share and liquidation preference of $ 25.00 per share (the “Series B Preferred Stock”), for net proceeds of approximately
+Added: $ 10,655,000 .
+Added: The Series B Preferred Stock was not convertible into our common stock, had no voting rights , except as required by
+Added: Delaware law, and was redeemable by the Company at any time.
+Added: Holders of Series B Preferred Stock were entitled to cumulative cash dividends
+Added: at the rate of 9.50 % of the $ 25.00 liquidation preference per year;
+Added: provided, however, that for each thirty (30) day period
+Added: following May 5, 2021, the dividend rate increased at various rates, except as otherwise limited by applicable law.
+Added: Dividends were payable
+Added: quarterly in arrears, on or about the 15th of January, April, July and October, beginning on or about July 15, 2021.
June 2021, the Company redeemed all of the outstanding shares of the Series B Preferred Stock.
1 unchanged sentence
of Series B Preferred Stock outstanding was equal to $ 25.00 per share, plus accrued and unpaid dividends, which in aggregate totaled
−Removed: During the year ended December 31, 2021, the Company recorded preferred stock cash dividends and deemed dividends equal to $ 472 .
+Added: $ 11,127,000 .
+Added: During the year ended December 31, 2021, the Company recorded preferred stock cash dividends and deemed dividends equal
+Added: to $ 472,000 .
each of December 31, 2022 and 2021, the Company had 50,000,000 shares of common stock, $ 0.001 par value, authorized.
1 unchanged sentence
the year ended December 31, 2022:
−Removed: Company issued 311,369 shares of its common stock upon the cashless exercise of warrants
−Removed: to purchase 406,539 shares of common stock with exercise prices between $ 1.79 and $ 3.75 per
−Removed: Company issued 25,480 shares of its common stock and received net proceeds of $ 65 upon the
−Removed: exercise of options to purchase 25,480 shares of common stock with exercise prices between
+Added: Company issued 53,594 shares of common stock to Mark L.
+Added: Baum, the Company’s
+Added: Chief Executive Officer, upon the cashless exercise of options to purchase 125,000 shares
+Added: at an exercise price of $ 2.40 per share.
+Added: The Company withheld from Mr.
+Added: Baum 36,014 shares
+Added: as consideration for the cashless exercise and an additional 35,392 shares for
+Added: payroll tax obligations totaling $ 295,000 ;
+Added: Company issued 306,347 shares of its common stock upon the cashless exercise of
+Added: warrants to purchase 373,847 shares of common stock with an exercise price of $ 2.08 per
+Added: Company issued 4,054 shares of common stock to a consultant upon the cashless exercise
+Added: of options to purchase 15,995 shares at an exercise price of $ 7.07 per share.
+Added: The Company withheld 11,941 shares as consideration for the cashless exercise ;
+Added: Company issued 15,625 shares of common stock to a consultant and received net proceeds
+Added: of $ 55,000 upon the exercise of options to purchase 15,625 shares of common stock
+Added: at an exercise price of $ 3.50 per share ;
+Added: Company issued 132,100 shares of common stock and received net proceeds of $ 587,000 upon
+Added: the exercise of options to purchase 132,100 shares of common stock with exercise
+Added: prices between $ 1.70 to $ 8.40 per share ;
+Added: RSUs granted at various dates to employees of the Company vested, and the Company issued
+Added: 110,621 shares of common stock to the employees, net of 74,379 shares of common stock withheld
+Added: for payroll tax withholdings totaling $ 581,000 ;
+Added: ● 35,693 shares
+Added: of the Company’s common stock underlying RSUs issued to directors vested, but the issuance
+Added: and delivery of these shares are deferred until the applicable director resigns .
+Added: During the Year Ended December 31, 2021
+Added: the year ended December 31, 2021:
+Added: Company issued 311,369 shares of its common stock upon the cashless exercise of
+Added: warrants to purchase 406,539 shares of common stock with exercise prices between
$ 1.79 and $ 3.75 per share;
+Added: Company issued 25,480 shares of its common stock and received net proceeds of $ 65,000
+Added: upon the exercise of options to purchase 25,480 shares of common stock with exercise
+Added: prices between $ 1.70 and $ 4.29 per share;
Company issued 715,871 shares of its common stock to Mark L.
−Removed: Baum, its Chief Executive Officer,
−Removed: upon the vesting of 1,050,000 performance-based restricted stock units.
−Removed: The Company withheld
−Removed: 334,129 shares of common stock to Mr.
−Removed: Baum valued at $ 2,760 for payroll tax purposes;
+Added: Baum, its Chief Executive
+Added: Officer, upon the vesting of 1,050,000 performance-based restricted stock units.
+Added: The Company withheld 334,129 shares of common stock to Mr.
+Added: Baum valued at $ 2,760,000 for
+Added: payroll tax purposes;
Company issued 100,168 shares of common stock to Andrew R.
−Removed: Boll, its Chief Financial Officer,
−Removed: upon the vesting of 157,500 performance-based restricted stock units.
−Removed: The Company withheld
−Removed: 57,332 shares of common stock to Mr.
−Removed: Boll valued at $ 468 for payroll tax purposes;
−Removed: shares of the Company’s common stock underlying RSUs issued to directors vested, but
−Removed: the issuance and delivery of these shares are deferred until the applicable director resigns.
−Removed: During the Year Ended December 31, 2020
−Removed: the year ended December 31, 2020:
−Removed: Company issued 30,000 shares of its restricted common stock, with an initial fair value of
−Removed: $ 167 , as consideration for commission expenses incurred during the year ended December 31,
−Removed: 2019 and the year ended December 31, 2020;
−Removed: Company issued 4,161 shares of its common stock upon the cashless exercise of options to
−Removed: purchase 16,750 shares of common stock, with exercise prices ranging from $ 1.70 to $ 4.05
−Removed: per share, net of 3,564 shares of common stock withheld for payroll tax withholdings;
−Removed: Company issued 2,998 shares of its common stock upon the exercise of options to purchase
−Removed: 2,998 shares of common stock, with exercise prices ranging from $ 3.04 to $ 3.20 per share,
−Removed: and paid $ 8 related to payroll tax withholdings;
−Removed: Company issued 185,785 shares of its common stock underlying RSUs held by directors that
−Removed: The RSUs had previously vested, including 26,721 RSUs during the year ended December
−Removed: 31, 2020, but the issuance and delivery of the shares were deferred until the director resigned;
−Removed: shares of the Company’s common stock underlying RSUs issued to directors vested, but
−Removed: the issuance and delivery of these shares are deferred until the resignation of a director.
+Added: Boll, its Chief Financial
+Added: Officer, upon the vesting of 157,500 performance-based restricted stock units.
+Added: The Company withheld 57,332 shares of common stock to Mr.
+Added: Boll valued at $ 468,000 for
+Added: payroll tax purposes;
+Added: ● 67,297 shares
+Added: of the Company’s common stock underlying RSUs issued to directors vested, but the issuance
+Added: and delivery of these shares are deferred until the applicable director resigns.
September 17, 2007, the Company’s Board of Directors and stockholders adopted the Company’s 2007 Incentive Stock and Awards
2 unchanged sentences
The 2007 Plan reached its term in September 2017, and we can no longer issue additional awards under this
−Removed: however, options previously issued under the 2007 Plan will remain outstanding until they are exercised, reach their maturity
−Removed: or are otherwise cancelled/forfeited.
+Added: plan, however, options previously issued under the 2007 Plan will remain outstanding until they are exercised, reach their maturity or
+Added: are otherwise cancelled/forfeited.
On June 13, 2017, the Company’s Board of Directors and stockholders adopted the Company’s
1 unchanged sentence
with the 2007 Plan, the “Plans”).
−Removed: As of December 31, 2021, the 2017 Plan provides for the issuance of a maximum of 6,000,000
−Removed: shares of the Company’s common stock.
−Removed: purposes of the Plans are to attract and retain directors, officers, consultants, advisors and employees whose services are considered
−Removed: valuable, to encourage a sense of proprietorship and to stimulate an active interest of such persons in the Company’s development
−Removed: and financial success.
−Removed: Under the Plans, the Company is authorized to issue incentive stock options intended to qualify under Section
−Removed: 422 of the Internal Revenue Code of 1986, as amended, non-qualified stock options, restricted stock units and restricted stock.
−Removed: are administered by the Compensation Committee of the Company’s Board of Directors.
−Removed: The Company had 2,399,649
−Removed: shares available for future issuances under
−Removed: the 2017 Plan at December 31, 2021.
+Added: As of December 31, 2021, the 2017 Plan provides for the issuance of a maximum of 6,000,000 shares
+Added: of the Company’s common stock.
+Added: The purpose of the Plans are to attract and retain directors, officers, consultants, advisors and
+Added: employees whose services are considered valuable, to encourage a sense of proprietorship and to stimulate an active interest of such
+Added: persons in the Company’s development and financial success.
+Added: Under the Plans, the Company is authorized to issue incentive stock
+Added: options intended to qualify under Section 422 of the Internal Revenue Code of 1986, as amended, non-qualified stock options, restricted
+Added: stock units and restricted stock.
+Added: The Plans are administered by the Compensation Committee of the Company’s Board of Directors.
+Added: The Company had 2,057,155 shares available for future issuances under the 2017 Plan at December 31, 2022.
summary of stock option activity under the Plan for the year ended December 31, 2022 is as follows:
−Removed: SCHEDULE OF STOCK OPTION PLAN ACTIVITY
+Added: OF STOCK OPTION PLAN ACTIVITY
+Added: Number of shares
+Added: Weighted Avg.
Exercise Price
−Removed: Remaining Contractual Life
+Added: Weighted Avg.
+Added: Contractual Life
Intrinsic Value
−Removed: outstanding - January 1, 2021
−Removed: cancelled/forfeit
−Removed: outstanding - December 31, 2021
−Removed: vested and expected to vest
+Added: Options outstanding – January 1, 2022
+Added: Options granted
+Added: Options exercised
+Added: Options cancelled/forfeited
+Added: Options outstanding – December 31, 2022
+Added: Options exercisable
+Added: Options vested and expected to vest
aggregate intrinsic value in the table above represents the total pre-tax amount of the proceeds, net of exercise price, which would
6 unchanged sentences
on which the common stock was then listed, at the grant date and have contractual terms of 10 years.
−Removed: Vesting terms for options granted
−Removed: to employees and consultants during the year ended December 31, 2021 generally included one of the following vesting schedules:
−Removed: the shares subject to the option vest and become exercisable on the first anniversary of the grant date and the remaining 75% of the
−Removed: shares subject to the option vest and become exercisable quarterly in equal installments thereafter over three years;
−Removed: and 100% of the
−Removed: shares subject to the option vest on a quarterly basis in equal installments over three years.
−Removed: Certain option awards provide for accelerated
−Removed: 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 .
+Added: Vesting terms for
+Added: options granted to employees and consultants during the year ended December 31, 2022 generally included one of the following vesting
+Added: 25% of the shares subject to the option vest and become exercisable on the first anniversary of the grant date and the remaining
+Added: 75% of the shares subject to the option vest and become exercisable quarterly in equal installments thereafter over three years ;
+Added: 100% of the shares subject to the option vest on a quarterly basis in equal installments over three years.
+Added: Certain option awards provide
+Added: 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
+Added: award agreement.
July 31, 2015, the Company granted to its Chief Executive Officer, Mark Baum, an option (the “Baum Performance Option”) to
−Removed: purchase 600,000 shares of the Company’s common stock at an exercise price of $ 7.87 per share under the 2007 Plan subject to the
−Removed: satisfaction of certain market-based vesting criteria.
−Removed: The market-based vesting criteria are separated into five tranches and require
−Removed: that the Company achieve and maintain certain average stock price targets ranging from $ 9 per share to $ 15 per share during the five
−Removed: year period following the grant date.
−Removed: On June 4, 2020, the Company amended the Baum Performance Option, to extend the vesting and contractual
−Removed: term by 5 years.
−Removed: The Company treated this amendment as a modification to the Baum Performance Option for accounting purposes.
−Removed: 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
−Removed: rate of 0.40 %.
+Added: purchase 600,000 shares of the Company’s common stock at an exercise price of $ 7.87 per share under the 2007 Plan
+Added: subject to the satisfaction of certain market-based vesting criteria.
+Added: The market-based vesting criteria are separated into five tranches
+Added: and require that the Company achieve and maintain certain average stock price targets ranging from $ 9 per share to $ 15 per
+Added: share during the five year period following the grant date.
+Added: On June 4, 2020, the Company amended the Baum Performance Option, to extend
+Added: the vesting and contractual term by 5 years.
+Added: The Company treated this amendment as a modification to the Baum Performance Option
+Added: for accounting purposes.
+Added: The fair value of the modification was $ 1,876,000 using a Monte Carlo simulation model with a five-year
+Added: life, 70 % volatility and a risk-free interest rate of 0.40 % .
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
19 unchanged sentences
used for valuing options granted to employees:
−Removed: SCHEDULE OF FAIR VALUE ASSUMPTIONS
−Removed: Weighted-average
−Removed: fair value of options granted
−Removed: terms (in years)
−Removed: interest rate
+Added: OF FAIR VALUE ASSUMPTIONS
+Added: Weighted-average fair value of options granted
+Added: Expected terms (in years)
+Added: Expected volatility
+Added: Risk-free interest rate
+Added: 1.54 – 3.70 %
+Added: 0.39 – 0.45 %
+Added: Dividend yield
following table summarizes information about stock options outstanding and exercisable at December 31, 2022:
−Removed: SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE
−Removed: of Exercise Prices
−Removed: of December 31, 2021, there was approximately $ 1,397 of total unrecognized compensation expense related to unvested stock options granted
−Removed: under the Plan.
+Added: OF STOCK OPTION OUTSTANDING AND EXERCISABLE
+Added: Options Outstanding
+Added: Options Exercisable
+Added: Exercise Prices
+Added: Life in Years
+Added: $ 1.47 - $ 2.23
+Added: $ 2.40 - $ 3.50
+Added: $ 4.08 - $ 6.30
+Added: $ 6.75 - $ 7.30
+Added: $ 7.37 - $ 7.79
+Added: $ 7.89 - $ 8.98
+Added: $ 1.47 - $ 12.38
+Added: of December 31, 2022, there was approximately $ 1,560,000 of total unrecognized compensation expense related to unvested stock options
+Added: granted under the Plan.
That expense is expected to be recognized over the weighted-average remaining vesting period of 4.88 years.
−Removed: The stock-based
−Removed: compensation for all stock options was $ 1,636 and $ 1,579 during the years ended December 31, 2021 and 2020, respectively.
+Added: The stock-based compensation for all stock options was $ 1,130,000 and $ 1,636,000 during the years ended December 31, 2022 and 2021, respectively.
Stock Units/Performance Stock Units
3 unchanged sentences
During the Year Ended December 31, 2022
−Removed: the year ended December 31, 2020, 161,000 RSUs with a fair market value of $ 1,025 were issued to certain employees;
−Removed: the RSUs vest in
−Removed: full on the third anniversary of the grant date.
−Removed: the year ended December 31, 2020, the Company’s board of directors were granted 90,524 RSUs with a fair market value $ 511 which
−Removed: vest on a quarterly basis, over a one-year term in equal installments, subject to the director’s continued service at the vesting
−Removed: date, but the issuance and delivery of these shares are deferred until the director resigns.
+Added: the year ended December 31, 2022, the Company’s board of directors were granted 65,615 RSUs with a fair market value
+Added: of $ 500,000 , which vest in equal quarterly installments over one year.
summary of the Company’s RSU activity and related information for the year ended December 31, 2022 is as follows:
−Removed: Average Grant
−Removed: Date Fair Value
−Removed: unvested - January 1, 2020
−Removed: cancelled/forfeited
−Removed: unvested at December 31, 2020
+Added: OF RESTRICTED STOCK UNITS ACTIVITY
+Added: Number of RSUs
+Added: Weighted Average
+Added: Grant Date Fair Value
+Added: RSUs unvested – January 1, 2022
+Added: RSUs cancelled/forfeit
+Added: RSUs unvested at December 31, 2022
+Added: of December 31, 2022, the total unrecognized compensation expense related to unvested RSUs was approximately $ 4,205,000 which is expected
+Added: to be recognized over a weighted-average period of 0.60 years, based on estimated vesting schedules.
+Added: The stock-based compensation for
+Added: RSUs was $ 6,844,000 and $ 4,022,000 during the years ended December 31, 2022 and 2021, respectively.
During the Year Ended December 31, 2021
the year ended December 31, 2021, 300,000 RSUs with a fair market value of $ 2,670,000 were issued to certain employees;
−Removed: the RSUs vest in
−Removed: full on the third anniversary of the grant date.
−Removed: the year ended December 31, 2021, the Company’s board of directors were granted 38,576 RSUs with a fair market value of $ 400 , which
−Removed: vest in equal quarterly installments over one year.
−Removed: the year ended December 31, 2021, the Company granted 1,567,913 performance stock units (“PSUs”) to members of its senior
−Removed: management including Mark Baum, Chief Executive Officer, Andrew Boll, Chief Financial Officer, and John Saharek, President of ImprimisRx
−Removed: , which are subject to the satisfaction of certain market-based and continued service conditions (the “2021 PSUs”).
−Removed: PSUs are separated into four tranches and require that the Company achieve and maintain certain levels of total stockholder returns (“TSR”)
−Removed: ranging from 50% to 175% per share during the five-year period following the grant date.
−Removed: TSR is based on the aggregate of:
−Removed: (i) the percent
−Removed: increase of the closing price of the Company’s common stock from July 22, 2021;
−Removed: and (ii) any dividends or like stockholder distributions
−Removed: as specified in the table below.
−Removed: With certain limited exceptions, in addition to reaching the TSR targets, the employee must be employed
−Removed: with the Company on the second anniversary of the grant date in order for the 2021 PSUs to vest.
+Added: the RSUs vest in full on the third anniversary of the grant date.
+Added: the year ended December 31, 2021, the Company’s board of directors were granted 38,576 RSUs with a fair market value
+Added: of $ 400,000 , which vest in equal quarterly installments over one year.
+Added: the year ended December 31, 2021, the Company granted 1,567,913 performance stock units (“PSUs”) to members of
+Added: its senior management including Mark Baum, Chief Executive Officer, Andrew Boll, Chief Financial Officer, and John Saharek, President
+Added: of ImprimisRx , which are subject to the satisfaction of certain market-based and continued service conditions (the “2021 PSUs”).
+Added: The 2021 PSUs are separated into four tranches and require that the Company achieve and maintain certain levels of total stockholder
+Added: returns (“TSR”) ranging from 50% to 175% per share during the five-year period following the grant date.
+Added: TSR is based on
+Added: the aggregate of:
+Added: (i) the percent increase of the closing price of the Company’s common stock from July 22, 2021;
+Added: dividends or like stockholder distributions as specified in the table below.
+Added: With certain limited exceptions, in addition to reaching
+Added: the TSR targets, the employee must be employed with the Company on the second anniversary of the grant date in order for the 2021 PSUs
OF SHARE BASED COMPENSATION PERFORMANCE STOCK UNITS AWARD ACTIVITY
+Added: Number of Shares
Target Share Price*
−Removed: assumes that no dividends or like distributions are made to shareholders of the Company.
+Added: 50% or greater
+Added: 100% or greater
+Added: 150% or greater
+Added: 175% or greater
+Added: * Target Share Price assumes
+Added: that no dividends or like distributions are made to shareholders of the Company.
If such distributions are made, the Target Share
−Removed: Price would decrease accordingly, to the benefit of the employee, to account for the dividend/distribution as a part of TSR.
−Removed: fair value of the 2021 PSUs was $ 10,113
−Removed: using a Monte Carlo Simulation with a five-year
−Removed: volatility and a risk free interest rate of 0.72 %.
+Added: Price would decrease accordingly, to the benefit of the employee, to account for the dividend/distribution as a part of
+Added: fair value of the 2021 PSUs was $ 10,113,000 using a Monte Carlo Simulation with a five-year life, 75 % volatility
+Added: and a risk free interest rate of 0.72 % .
The fair value amount is being amortized over a two-year derived service period.
summary of the Company’s RSU activity and related information for the year ended December 31, 2021 is as follows:
−Removed: SCHEDULE OF RESTRICTED STOCK UNITS ACTIVITY
−Removed: Weighted Average Grant Date
−Removed: unvested - January 1, 2021
+Added: Number of RSUs
+Added: Weighted Average
+Added: Grant Date Fair Value
+Added: RSUs unvested - January 1, 2021
( 1,274,797 )
−Removed: cancelled/forfeit
−Removed: unvested at December 31, 2021
−Removed: of December 31, 2021, the total unrecognized compensation expense related to unvested RSUs was approximately $ 10,550 which is expected
−Removed: to be recognized over a weighted-average period of 1.48 years, based on estimated vesting schedules.
−Removed: The stock-based compensation for
−Removed: RSUs was $ 4,022 and $ 1,167 during the years ended December 31, 2021 and 2020, respectively.
+Added: RSUs cancelled/forfeit
+Added: RSUs unvested at December 31, 2021
Stock-Based Transactions
−Removed: Company recognized $ 87 and $ 26 in stock-based compensation expense related to subsidiary stock options during the years ended December
−Removed: 31, 2021 and 2020, respectively.
+Added: Company recognized $ 0 and $ 87,000 in stock-based compensation expense related to subsidiary stock options during the years
+Added: ended December 31, 2022 and 2021, respectively.
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:
−Removed: SCHEDULE OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES DIRECTORS CONSULTANTS
−Removed: the Year Ended December 31,
−Removed: – selling, general and administrative
−Removed: – selling, general and administrative
−Removed: – selling, general and administrative
−Removed: time to time, the Company issues warrants to purchase shares of the Company’s common stock to investors, lenders (see Note 13),
−Removed: underwriters and other non-employees for services rendered or to be rendered in the future.
+Added: OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES DIRECTORS CONSULTANTS
+Added: For the Year Ended December 31,
+Added: Employees – selling, general and administrative
+Added: Employees – R&D
+Added: Directors – selling, general and administrative
+Added: Consultants – selling, general and administrative
+Added: Stock-based compensation
+Added: time to time, the Company has issued warrants to purchase shares of the Company’s common stock to investors, lenders, underwriters
+Added: and other non-employees for services rendered or to be rendered in the future.
summary of warrant activity during the year ended December 31, 2022 is as follows:
−Removed: SCHEDULE OF WARRANTS ACTIVITY
−Removed: of Shares Subject to Warrants Outstanding
+Added: OF WARRANTS ACTIVITY
+Added: Number of Shares Subject to Warrants Outstanding
+Added: Weighted Avg.
Exercise Price
−Removed: outstanding - January 1, 2021
−Removed: outstanding and exercisable - December 31, 2021
−Removed: average remaining contractual life of the outstanding warrants in years - December 31, 2021
−Removed: warrants outstanding as of December 31, 2021 are included in the following table:
−Removed: SCHEDULE OF WARRANTS OUTSTANDING AND WARRANTS EXERCISABLE
−Removed: Outstanding and Exercisable
−Removed: warrants (see Note 13)
+Added: Warrants outstanding - January 1, 2022
+Added: Warrants outstanding - December 31, 2022
Company is subject to taxation in the United States, California, Florida, Georgia, Illinois, New Jersey, New York, Tennessee and Wisconsin.
−Removed: The Company’s income tax provision (benefit) for income taxes for the years ended December 31, 2021 and 2020 are summarized below:
−Removed: SCHEDULE OF PROVISION FOR INCOME TAXES
−Removed: in valuation allowance
−Removed: tax provision (benefit)
+Added: The Company’s income tax provision consists of the following for the years ended December 31, 2022 and 2021 are summarized below:
+Added: OF PROVISION FOR INCOME TAXES
+Added: Total current
+Added: $ ( 425,000 )
+Added: ( 1,944,000 )
+Added: Change in valuation allowance
+Added: ( 1,182,000 )
+Added: Total deferred
+Added: Income tax provision
reconciliation of income taxes computed by applying the statutory U.S.
1 unchanged sentence
to the income tax provision is as follows:
−Removed: SCHEDULE OF INCOME TAX RECONCILIATION
+Added: OF INCOME TAX RECONCILIATION
federal statutory tax rate
−Removed: tax benefit, net
−Removed: stock-based compensation
−Removed: off of NOLs due to previous change in ownership
−Removed: off of credits due to previous change in ownership
−Removed: of valuation allowance for write off of NOLs and credits due to previous change in ownership
−Removed: income tax rate
+Added: State tax benefit, net
+Added: Employee stock-based compensation
+Added: Excess Employee Remuneration
+Added: W/O of IRC Sec 382 Limited NOLs
+Added: W/O of IRC Sec 383 Limited Credits
+Added: Reduction of VA for IRC Sec 382 and 383 W/O
+Added: Valuation allowance
+Added: Effective income tax rate
tax assets and liabilities reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities
2 unchanged sentences
tax assets are as follows:
−Removed: SCHEDULE OF DEFERRED TAX ASSETS AND LIABILITIES
−Removed: tax assets (liabilities):
−Removed: and amortization
−Removed: and development credits
−Removed: stock compensation
−Removed: Difference in Melt
−Removed: Difference in Surface
−Removed: Difference in Eton
−Removed: License Agreement
−Removed: License Agreement
−Removed: License Agreement
−Removed: stock purchase identifiable intangibles
−Removed: Basis difference in Melt loan
−Removed: lease liabilities
−Removed: lease right-of-use assets
−Removed: deferred tax assets, net
−Removed: deferred tax liabilities
+Added: OF DEFERRED TAX ASSETS AND LIABILITIES
+Added: Deferred tax assets (liabilities):
+Added: Depreciation and amortization
+Added: Research and development credits
+Added: Deferred stock compensation
+Added: Basis Difference in Eton
+Added: ( 1,684,000 )
+Added: ( 2,511,000 )
+Added: Sintetica License Agreement
+Added: Sparcs License Agreement
+Added: Novartis License Agreement
+Added: Basis difference in Melt Loan Value
+Added: Park stock purchase identifiable intangibles
+Added: Limitation Under 163(j)
+Added: Section 174 Capital Expenses
+Added: ASC 842 Lease Liability
+Added: ASC 842 ROU Asset
+Added: ( 2,263,000 )
+Added: ( 1,753,000 )
+Added: Total deferred tax assets, net
+Added: Valuation allowance
+Added: ( 17,022,000 )
+Added: ( 18,204,000 )
+Added: Net deferred tax liabilities
of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain.
1 unchanged sentence
deferred tax assets have been fully offset by a valuation allowance.
−Removed: The valuation allowance increased by approximately $ 2,369
−Removed: and increased by approximately $ 633
−Removed: during 2021 and 2020, respectively.
−Removed: of December 31, 2021, the Company had federal and state net operating loss carryforwards of approximately $ 34,400 and $ 53,200 , respectively,
−Removed: which will begin to expire in 2027 , unless previously utilized, and will begin to expire for state purposes in 2026.
−Removed: In addition, the
−Removed: Company has federal net operating loss carryforward of $3,900 generated after 2017 that can be carried over indefinitely and may be used
−Removed: to offset up to 80% of federal taxable income .
−Removed: of December 31, 2021 the Company had federal and state research and development credit carryforwards of approximately $ 47 and $ 54 , respectively,
−Removed: which will begin to expire in 2026 , unless previously utilized.
−Removed: For state purposes, the state research and development credit carryforwards
−Removed: can be carried over indefinitely.
+Added: The valuation allowance decreased by approximately $ 1,182,000 and
+Added: increased by approximately $ 2,369,000 during 2022 and 2021, respectively.
+Added: of December 31, 2022, the Company had federal and state net operating loss carryforwards of approximately $ 23,900,000 and $ 45,000,000 ,
+Added: respectively, which will begin to expire in 2027 , unless previously utilized, and will begin to expire for state purposes in 2026.
+Added: addition, the Company has federal net operating loss carryforward of $3,900,000 generated after 2017 that can be carried over indefinitely
+Added: and may be used to offset up to 80% of federal taxable income .
+Added: of December 31, 2022 the Company had federal and state research and development credit carryforwards of approximately $ 47,000 and $ 54,000 ,
+Added: respectively, which will begin to expire in 2026 , unless previously utilized.
+Added: For state purposes, the state research and development
+Added: credit carryforwards can be carried over indefinitely.
of the net operating losses and research and development carryforwards may be subject to a substantial annual limitation due to ownership
10 unchanged sentences
in such an ownership change, or could result in an ownership change in the future upon subsequent disposition.
−Removed: of December 31, 2021, the Company determined that it had net operating loss carryforwards of approximately $ 12,600
−Removed: and state net operating loss carryforwards
−Removed: of approximately $ 9,400
−Removed: restricted under IRC Section 382 of the Internal
−Removed: Revenue Code related to a 2011 change in ownership.
−Removed: Section 382 of the Internal Revenue Code limits the utilization of net operating
−Removed: losses when ownership changes, as defined by that section, occur.
−Removed: Due to the Section 382 limitation, and the length of time available
−Removed: to fully utilize the net operating loss carryforwards, the Company removed these NOLs from deferred tax assets with a corresponding reduction
−Removed: of the valuation allowance.
−Removed: Similarly, under IRC Section 383 which limits the utilization of credits when ownership changes occur, the
−Removed: Company removed approximately $ 300
−Removed: of federal credit and $ 300
−Removed: of state credits from deferred tax assets with
−Removed: a corresponding reduction of valuation allowance.
−Removed: Company did not have any unrecognized tax benefits as of December 31, 2021 and 2020, all of which is offset by a full valuation allowance.
+Added: of December 31, 2022, the Company determined that it had net operating loss carryforwards of approximately $ 12,500,000 and state net
+Added: operating loss carryforwards of approximately $ 9,400 ,000 restricted under IRC Section 382 of the Internal Revenue Code related to a 2011
+Added: change in ownership.
+Added: Section 382 of the Internal Revenue Code limits the utilization of net operating losses when ownership changes,
+Added: as defined by that section, occur.
+Added: Due to the Section 382 limitation, and the length of time available to fully utilize the net operating
+Added: loss carryforwards, the Company removed these NOLs from deferred tax assets with a corresponding reduction of the valuation allowance.
+Added: Similarly, under IRC Section 383 which limits the utilization of credits when ownership changes occur, the Company removed approximately
+Added: $ 300,000 of federal credit and $ 300,000 of state credits from deferred tax assets with a corresponding reduction of valuation allowance.
+Added: Company did not have any unrecognized tax benefits as of December 31, 2022 and 2021.
These unrecognized tax benefits, if recognized, would not affect the effective tax rate.
3 unchanged sentences
OF UNRECOGNIZED TAX BENEFITS
−Removed: at January 1, 2021
−Removed: for tax positions related to current year
−Removed: Additions/(reductions)
−Removed: for tax positions related to prior years
−Removed: at December 31, 2021
−Removed: unrecognized tax benefits as of December 31, 2021
+Added: Fed & State Tax
+Added: Balance at January 1, 2022
+Added: Additions for tax positions related to current year
+Added: Additions/(reductions) for tax positions related to prior years
+Added: Balance at December 31, 2022
+Added: Total unrecognized tax benefits as of December 31, 2022
+Added: Tax Cuts and Jobs Act of 2017 (TCJA) included changes to the treatment of research and development expenses under IRC Section 174.
+Added: Formerly, a company could deduct research and development expenses under IRC Section 174 as incurred.
+Added: Effective for tax years
+Added: beginning after December 31, 2021, research and development expenses under IRC Section 174 are required to be capitalized, with an
+Added: amortization period of five years for costs incurred un the US and 15
+Added: years for costs incurred in a non-US jurisdiction.
+Added: The Company has incurred approximately $ 2,191,000
+Added: of US research and development costs during the year ended December 31, 2022.
EMPLOYEE SAVINGS PLAN
3 unchanged sentences
subject to annual limits.
−Removed: The Company contributed approximately $ 282 and $ 272 to the plan during the years ended December 31, 2021 and
−Removed: 2020, respectively.
+Added: The Company contributed approximately $ 397,000 and $ 282,000 to the plan during the years ended December 31,
+Added: 2022 and 2021, respectively.
COMMITMENTS AND CONTINGENCIES
+Added: the ordinary course of business, the Company is involved in various legal proceedings, government investigations and other matters that
+Added: are complex in nature and have outcomes that are difficult to predict.
+Added: See also Part I, Item 1A.
+Added: Risk Factors .
+Added: describes legal proceedings and other matters that are/were significant or that it believes could become significant in this footnote.
+Added: Company records accruals for loss contingencies to the extent that it concludes it is probable that a liability has been incurred and
+Added: the amount of the related loss can be reasonably estimated.
+Added: The Company evaluates, on a quarterly basis, developments in legal proceedings
+Added: and other matters that could cause an increase or decrease in the amount of a liability that has been accrued previously.
+Added: Company’s legal proceedings involve various aspects of its business and a variety of claims, some of which present novel factual
+Added: allegations and/or unique legal theories.
+Added: Typically, a number of the matters pending against the Company are at early stages of the legal
+Added: process, which in complex proceedings of the sort the Company face often extend for several years.
+Added: While it is not possible to accurately
+Added: predict or determine the eventual outcomes of matters that have not concluded, an adverse determination in one or more of matter (whether
+Added: discussed in this footnote or not) currently pending may have a material adverse effect on the Company’s consolidated results of
+Added: operations, financial position or cash flows.
+Added: recent developments concerning the Company’s legal proceedings it believes are or were material to its business and other matters
+Added: are discussed below:
Drug Solutions et al.
9 unchanged sentences
to resolve all claims and pending matters related to this lawsuit.
−Removed: During the year ended December 31, 2021, the Company recorded $ 1,500
−Removed: in selling, general and administrative expenses related to the Settlement Agreement.
+Added: During the year ended December 31, 2021, the Company recorded $ 1,500,000 in
+Added: selling, general and administrative expenses related to the Settlement Agreement.
Except for the one-time payment of $ 1,500,000 the Company
18 unchanged sentences
consolidated financial position and results of operations as a result of the resolution of this matter.
−Removed: the ordinary course of business, the Company may face various claims brought by third parties and it may, from time to time, make claims
−Removed: or take legal actions to assert its rights, including intellectual property disputes, contractual disputes and other commercial disputes.
−Removed: Any of these claims could subject the Company to litigation.
addition to the indemnification provisions contained in the Company’s charter documents, the Company generally enters into separate
21 unchanged sentences
certain future levels by the end of their terms, as applicable.
−Removed: The Company accrued and recorded in additional paid-in capital of
−Removed: related to stock-based payments for these agreements
−Removed: during the years ended December 31, 2021 and 2020, respectively, and $ 3,640
−Removed: were incurred under these agreements for commission
−Removed: expenses during the years ended December 31, 2021 and 2020, respectively, which are included in selling, general and administrative expenses.
−Removed: Purchase, License and Related Agreements
+Added: The Company incurred $ 4,274,000 and $ 3,640,000 under these agreements
+Added: for commission expenses during the years ended December 31, 2022 and 2021, respectively, which are included in selling, general and administrative
+Added: Asset Purchase, License and Related Agreements
Company has acquired and sourced intellectual property rights related to certain proprietary innovations from certain inventors and related
24 unchanged sentences
the Inventors.
−Removed: At December 31, 2021 and 2020, $ 251
−Removed: were accrued in accounts payable and accrued
−Removed: expenses related to these agreements.
−Removed: During the years ended December 31, 2021 and 2020, $ 991
−Removed: respectively, were incurred under these agreements as royalty expenses.
−Removed: Rights to MAXITROL Eye Drops, IOPIDINE and MOXEZA
−Removed: December 17, 2021 (the “Closing Date”), the Company entered into the NVS Agreement (see Note 10), pursuant to which the Company
−Removed: purchased from NVS the exclusive commercial rights to the NVS Products in the U.S.
−Removed: The Company made a one-time payment of $ 14,050
−Removed: to NVS for the U.S.
−Removed: rights to the NVS Products and their related intellectual property .
−Removed: to the NVS Agreement and various ancillary agreements, immediately following the Closing
−Removed: Date and subject to certain conditions, for a period of up to six months, and prior to the transfer of the NVS
−Removed: Products NDAs (the “ NVS NDAs”) to the Company, NVS will continue to sell
−Removed: the NVS Products on the Company’s behalf and transfer the net profit from the sale
−Removed: of the NVS Products to the Company.
−Removed: NVS has agreed to supply certain NVS
−Removed: Products to the Company for a period of time after the NVS NDAs are transferred to
−Removed: the Company and to assist with technology transfer of the NVS Products manufacturing to
−Removed: other third-party manufacturers, if needed.
−Removed: July 2021, the Company entered into a License and Supply Agreement (the “Sintetica Agreement”) with Sintetica S.A.
−Removed: (“Sintetica”),
−Removed: pursuant to which Sintetica granted the Company the exclusive license and marketing rights to its patented ophthalmic drug candidate
−Removed: (“AMP-100”) in the U.S.
−Removed: to the Sintetica Agreement, the Company will pay Sintetica a per unit transfer price to supply AMP-100, along with a per unit royalty
−Removed: for units sold.
−Removed: The Company is required to pay Sintetica up to $ 18,000 in one-time milestone payments including a $ 5,000 payment (the
−Removed: “Upfront Payment”) due within 30 days of signing the Sintetica Agreement and the balance of payments due upon achievement
−Removed: of certain regulatory and commercial milestones.
−Removed: Under the terms of the Sintetica Agreement, Sintetica will be responsible for regulatory
−Removed: filings for AMP-100 in the U.S.
−Removed: The Upfront Payment along with an additional milestone payment of $ 3,117 was paid and recorded as a R&D
−Removed: expenses during the year ended December 31, 2021.
−Removed: to certain limitations, the term of the Sintetica Agreement is ten years, and allows for a ten-year extension if certain sales thresholds
−Removed: August 2021, the Company entered into a License Agreement and a Basic Sale and Purchase Agreement (together, the “Wakamoto Agreements”)
−Removed: with Wakamoto Pharmaceutical Co., Ltd.
−Removed: (“Wakamoto”), pursuant to which Wakamoto granted the Company the exclusive license
−Removed: and marketing rights to its ophthalmic drug candidate (“MAQ-100”) in the U.S.
−Removed: to the Wakamoto Agreements, Wakamoto will supply MAQ-100 to the Company, and the Company
−Removed: will pay Wakamoto a per unit transfer price to supply MAQ-100.
−Removed: In addition, the Company is required to pay Wakamoto various one-time
−Removed: milestone payments totaling up to $ 2,000 upon the achievement of certain regulatory milestones and up to $ 6,200 upon the achievement
−Removed: of certain commercial milestones.
−Removed: Under the terms of the Agreements, the Company will be responsible for regulatory filings and fees
−Removed: for MAQ-100 in the U.S.
−Removed: Through December 31, 2021, no amounts have been paid or accrued under the Wakamoto agreement.
−Removed: to certain limitations, the term of the Agreements is for five years from the date of the FDA’s market approval of MAQ-100 and
−Removed: allows for a five-year extension if certain unit sales thresholds are met.
−Removed: Commercial Alliance Agreement
−Removed: August 2020, the Company, through its wholly-owned subsidiary ImprimisRx, LLC, entered into a Commercial Alliance Agreement (the “Dexycu
−Removed: Agreement”) with Eyepoint Pharmaceuticals, Inc.
−Removed: (“Eyepoint”), pursuant to which Eyepoint granted the Company the non-exclusive
−Removed: right to co-promote DEXYCU ® (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation
−Removed: following ocular surgery in the United States.
−Removed: to the Dexycu Agreement , Eyepoint will pay the Company a fee calculated based on the quarterly
−Removed: sales of DEXYCU in excess of predefined volumes to specific customers of the Company in the U.S.
−Removed: Under the terms of the Dexycu
−Removed: Agreement , the Company shall use commercially reasonable efforts to promote and market DEXYCU in the U.S.
−Removed: In December 2021,
−Removed: Ithe Company, entered into a letter agreement (the “Letter Agreement”) with EyePoint
−Removed: to expand the Dexycu Agreement.
−Removed: During the two-year term of the Letter Agreement, in exchange for EyePoint agreeing to pay the
−Removed: Company a commission based on all net sales of DEXYCU® in the U.S.
−Removed: the Company assumed full responsibility for the sales and marketing
−Removed: of DEXYCU and agreed to make offers of employment to eight EyePoint employees, and will be responsible for all sales and marketing related
−Removed: regulatory compliance.
−Removed: EyePoint retained control over all regulatory approvals and commercial rights for DEXYCU.
−Removed: The Letter Agreement
−Removed: was made effective as of January 1, 2022 and will continue through December 31, 2023, unless such term is amended by mutual agreement
−Removed: of the parties or terminated in accordance therewith.
−Removed: Letter Agreement also amended the Company’s required minimum sales levels based on the DEXYCU unit demand for the third quarter
−Removed: The failure to achieve these minimum sales levels could result in penalties payable by the Company to EyePoint;
−Removed: provided however,
−Removed: in no event shall a penalty, if any, exceed commissions payable by EyePoint to the Company.
−Removed: expiration or termination of the Letter Agreement, the parties will revert to the terms of the Dexycu Agreement in existence prior to
−Removed: the effectiveness of the Letter Agreement for the remainder of the original term of the Dexycu Agreement.
−Removed: The Letter Agreement provides
−Removed: that either party may terminate the Dexycu Agreement upon 30 days’ prior written notice in the event DEXYCU ceases to have Medicare
−Removed: Part B “pass-through” payment status for a period of not less than 6 months.
−Removed: The Company has an additional right to terminate
−Removed: the Letter Agreement with 30 days written notice if (i) a proposed or final Hospital Outpatient Prospective Payment System (HOPPS) rule
−Removed: issued by the Centers for Medicare & Medicaid Services (CMS) during calendar year 2022 does not contain an extension of the pass-through
−Removed: payment period for DEXYCU beyond December 31, 2022, and (ii) EyePoint has not otherwise waived any minimum sales for a respective quarterly
−Removed: to early termination, the Dexycu Agreement expires on August
−Removed: 1, 2025 , subject to specified notice periods
−Removed: and specified limitations, either party may terminate the Dexycu Agreement in the event
−Removed: of (i) uncured material breach by the other party or (ii) if DEXYCU ceases to have “pass-through” payment status.
−Removed: In addition, subject to certain limitations, the Company may terminate the Dexycu Agreement
−Removed: (i) for convenience subject to an extended specified notice period or (ii) in the event Eyepoint undergoes a change of control.
−Removed: may terminate the Dexycu Agreement , subject to specified notice periods and specified limitations,
−Removed: if the Company fails to achieve certain minimum sales levels during specified periods.
−Removed: During the years ended December 31, 2021 and 2020,
−Removed: the Company recorded $ 3,253
−Removed: respectively, in commission revenues related to the Dexycu Agreement.
+Added: At December 31, 2022 and 2021, $ 228,000 and $ 251,000 were accrued in accounts payable and accrued expenses
+Added: related to these agreements.
+Added: During the years ended December 31, 2022 and 2021 $ 910,000 and $ 991,000 , respectively, were incurred
+Added: under these agreements as royalty expenses.
License Agreement – Related Party
12 unchanged sentences
Lindstrom including:
−Removed: (i) an initial payment of $ 50 upon execution of the Klarity License Agreement, (ii) a second payment
−Removed: of $ 50 following the first $ 50 in net sales of the Klarity Product;
−Removed: and (iii) a final payment of $ 50 following the first $ 100 in net
−Removed: sales of the Klarity Product.
−Removed: All of the above referenced milestone payments were payable at the Company’s election in cash or
−Removed: shares of the Company’s restricted common stock.
−Removed: Lindstrom was paid $ 165 and $ 149 in cash during the years ended December 31,
−Removed: 2021 and 2020, respectively, and was due an additional $ 30 and $ 35 at December 31, 2021 and 2020, respectively.
−Removed: The Company incurred
−Removed: $ 160 and $ 129 for royalty expenses related to the Klarity License Agreement during the years ended December 31, 2021 and 2020, respectively.
+Added: (i) an initial payment of $ 50,000 upon execution of the Klarity License Agreement, (ii) a second
+Added: payment of $ 50,000 following the first $ 50,000 in net sales of the Klarity Product;
+Added: and (iii) a final payment of $ 50,000 following the
+Added: first $ 100,000 in net sales of the Klarity Product.
+Added: All of the above referenced milestone payments were payable at the Company’s
+Added: election in cash or shares of the Company’s restricted common stock.
+Added: Lindstrom was paid $ 274,000 and $ 165,000 in cash during
+Added: the years ended December 31, 2022 and 2021, respectively, and was due an additional $ 71,000 and $ 30,000 at December 31, 2022 and 2021,
+Added: respectively.
+Added: The Company incurred $ 315,000 and $ 160,000 for royalty expenses related to the Klarity License Agreement during the years
+Added: ended December 31, 2022 and 2021, respectively.
Asset Purchase Agreement – Related Party
10 unchanged sentences
Lindstrom including an initial payment of $ 33,000 upon execution of the Lindstrom APA.
−Removed: Lindstrom was
−Removed: paid $ 28 and $ 55 in cash during the year ended December 31, 2021 and 2020, respectively, and was due $ 8 and $ 7 at December 31, 2021 and
−Removed: 2020, respectively.
−Removed: The Company incurred $ 29 and $ 55 for royalty expenses related to the Lindstrom Agreement during the year ended December
−Removed: 31, 2021 and 2020, respectively.
+Added: was paid $ 32,000 and $ 28,000 in cash during the year ended December 31, 2022 and 2021, respectively, and was due $ 9,000 and $ 8,000 at
+Added: December 31, 2022 and 2021, respectively.
+Added: The Company incurred $ 33,000 and $ 29,000 for royalty expenses related to the Lindstrom Agreement
+Added: during the year ended December 31, 2022 and 2021, respectively.
Asset Purchase Agreement – Related Party
13 unchanged sentences
to the Presbyopia APA during the years ended December 31, 2022 and 2021.
+Added: Commercial Alliance Agreement - Terminated
+Added: August 2020, the Company, through its wholly owned subsidiary ImprimisRx, LLC, entered into a Commercial Alliance Agreement (the “Dexycu
+Added: Agreement”) with Eyepoint Pharmaceuticals, Inc.
+Added: (“Eyepoint”), pursuant to which Eyepoint granted the Company the non-exclusive
+Added: right to co-promote DEXYCU ® (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation
+Added: following ocular surgery in the United States.
+Added: to the Dexycu Agreement , Eyepoint pays the Company a fee calculated based on the quarterly
+Added: sales of DEXYCU in excess of predefined volumes to specific customers of the Company in the U.S.
+Added: Under the terms of the Dexycu
+Added: Agreement , the Company agreed to use commercially reasonable efforts to promote and market DEXYCU in the U.S.
+Added: to a mutual termination agreement entered into on October 7, 2022 the Dexycu Agreement
+Added: terminated on January 1, 2023.
+Added: Following the preliminary Hospital Outpatient Prospective Payment
+Added: System (HOPPS) rule proposed by the Centers for Medicare & Medicaid Services (CMS) in July of 2022, which did not contain an extension
+Added: of the pass-through payment period for Dexycu beyond December 31, 2022, the Company entered into a Mutual Termination Agreement (the
+Added: “Termination Agreement”) with Eyepoint on October 7, 2022, pursuant to which Eyepoint and the Company agreed (a) that the
+Added: Company will continue to support the sale of Dexycu through the fourth quarter of 2022, consistent with the Company’s level of
+Added: effort during the January through June 2022 period, (b) to decrease the required minimum quarterly sales levels based on Dexycu unit
+Added: demand for the fourth quarter of 2022, and (c) to terminate the Dexycu Agreement, along with ancillary letter agreements, effective January
+Added: the years ended December 31, 2022 and 2021, the Company recorded $ 3,866,000 and $ 3,253,000 , respectively, in commission revenues
+Added: related to the Dexycu Agreement.
Pharmaceuticals MAY-66 License Termination
2 unchanged sentences
Mayfield’s proprietary drug candidate MAY-66.
−Removed: Concurrent with the termination, TGV returned to Mayfield 300,000 shares of Mayfield’s
−Removed: common stock, constituting all of the equity held by TGV.
−Removed: Mayfield has no outstanding or remaining obligations under the TGV License.
+Added: Concurrent with the termination, TGV returned to Mayfield 300,000 shares
+Added: of Mayfield’s common stock, constituting all of the equity held by TGV.
+Added: Mayfield has no outstanding or remaining obligations under
+Added: the TGV License.
Pharmaceuticals MAY-44 APA Termination
2 unchanged sentences
the termination, Mayfield re-acquired 350,000 shares of its common stock from Elle.
−Removed: Mayfield has no outstanding or remaining obligations
−Removed: related to the MAY-44 APA.
+Added: Mayfield has no outstanding or remaining
+Added: obligations related to the MAY-44 APA.
License Termination
3 unchanged sentences
TGV returned to Stowe 1,750,000 shares of Stowe’s common stock, constituting all of the equity held by TGV.
−Removed: Stowe has no outstanding
−Removed: or remaining obligations under the Stowe License.
−Removed: SEGMENT INFORMATION AND CONCENTRATIONS
−Removed: evaluated the Company’s 2021 and 2020 performance based on operating segments.
−Removed: Segment performance for the Company’s two
−Removed: operating segments are based on segment contribution.
−Removed: The Company’s reportable segments consisted of (i) its commercial stage pharmaceutical compounding business (Pharmaceutical Compounding),
−Removed: generally including the operations of ImprimisRx;
−Removed: and (ii) its start-up operations associated with pharmaceutical drug development business
−Removed: (Pharmaceutical Drug Development).
−Removed: Segment contribution for the segments represents net revenues less cost of sales, R&D expenses,
−Removed: selling and marketing expenses, and select general and administrative expenses.
−Removed: Management does not evaluate the following items
−Removed: at the segment level:
−Removed: general and administrative expenses that result from shared infrastructure, including certain
−Removed: expenses associated with legal matters, public company costs (e.g.
−Removed: investor relations), board
−Removed: of directors and principal executive officers and other like shared expenses;
+Added: no outstanding or remaining obligations under the Stowe License.
+Added: SEGMENTS AND CONCENTRATIONS
+Added: evaluated the Company’s 2021 performance based on operating segments.
+Added: Segment performance for its two operating segments was based
+Added: on segment contribution.
+Added: Our reportable segments consisted of (i) our commercial stage pharmaceutical business (Pharmaceutical Compounding),
+Added: generally including the operations of our ImprimisRx business;
+Added: and (ii) our start-up operations associated with our pharmaceutical drug
+Added: development business (Pharmaceutical Drug Development).
+Added: Segment contribution for our segments represented net revenues less cost of sales,
+Added: R&D expenses, selling and marketing expenses, and select general and administrative expenses.
+Added: Management did not evaluate the following
+Added: items at the segment level:
expenses within selling, general and administrative expenses that result from the impact
2 unchanged sentences
acquisition and other shared costs;
+Added: general and administrative expenses that result from shared infrastructure, including certain
+Added: expenses associated with legal matters, our board of directors and principal executive officers,
+Added: investor relations and other like shared expenses;
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
−Removed: level, or such information has not been used by all segments;
+Added: level, or such information has not been used by both segments;
assets including capital expenditures.
−Removed: defines segment net revenues as pharmaceutical compounded
−Removed: drug sales, licenses and other revenues derived from related agreements.
+Added: defined segment net revenues as pharmaceutical compounded drug sales, revenues from licenses and other revenues derived from related
of sales within segment contribution includes direct and indirect costs to manufacture formulations and sell products, including active
1 unchanged sentence
tenant improvements depreciation, the write-off of obsolete inventory and other related expenses.
−Removed: general and administrative expenses consist mainly of personnel-related costs, marketing and promotion costs, distribution costs, professional
+Added: general and administrative expenses consisted mainly of personnel-related costs, marketing and promotion costs, distribution costs, professional
service costs, insurance, depreciation, facilities costs, transaction costs, and professional services costs, which are general in nature
and attributable to the segment.
−Removed: net revenues, segment operating expenses and segment contribution information consisted of the following for the years ended December
−Removed: 31, 2021 and 2020:
+Added: Segment net revenues, segment operating expenses and segment contribution information consisted of the following for the years ended
+Added: December 31, 2021:
SCHEDULE OF SEGMENT NET REVENUES, SEGMENT OPERATING EXPENSES AND SEGMENT CONTRIBUTION
−Removed: the Year Ended December 31, 2021
−Removed: Pharmaceutical
−Removed: Pharmaceutical
−Removed: general and administrative
−Removed: and development
−Removed: and development
−Removed: sales and impairments, net
−Removed: the Year Ended December 31, 2020
+Added: For the Year Ended December 31, 2021
Pharmaceutical
Pharmaceutical
−Removed: general and administrative
−Removed: and development
−Removed: and development
−Removed: sales and impairments, net
−Removed: Company categorizes revenues by geographic area based on selling location.
−Removed: All operations are currently located in the U.S.;
−Removed: total revenues are attributed to the U.S.
−Removed: All long-lived assets at December 31, 2021 and December 31, 2020 are located in the U.S.
−Removed: Beginning in 2022, due to shifts in the Company’s
−Removed: strategic plans to further focus on growing the Company’s ImprimisRx business and suspension of activities related to starting
−Removed: up development-stage pharmaceutical companies, along with changes to the Company’s organizational and internal reporting structure,
−Removed: management will no longer evaluate the Company’s business in two segments and will instead focus on the performance of the business
−Removed: as a single operating business.
+Added: Drug Development
+Added: Cost of sales
+Added: ( 18,214,000 )
+Added: ( 18,214,000 )
+Added: Operating expenses:
+Added: Selling, general and administrative
+Added: Research and development
+Added: Segment contribution
+Added: ( 8,674,000 )
+Added: ( 13,689,000 )
+Added: Research and development
+Added: ( 1,322,000 )
+Added: Asset sales and impairments, net
+Added: Operating income
+Added: in 2022, due to shifts in the Company’s strategic plans and its organizational structure, management no longer evaluates the Company’s
+Added: business in two segments and instead focuses on the performance of the business as a single operating business.
Concentrations
−Removed: Company has two products that each comprised more than 10% of total revenues.
−Removed: These products collectively accounted
−Removed: for 35 % and 35 % o f
−Removed: revenues during the years ended December 31, 2021 and 2020, respectively.
+Added: Company has two products that each comprised more than 10% of total revenues during the quarter.
+Added: These products collectively
+Added: accounted for 34 % and 35 % of revenues during the years ended December 31, 2022 and 2021, respectively.
Company sells its compounded formulations to a large number of customers.
1 unchanged sentence
Company’s total pharmacy sales for the years ended December 31, 2022 and 2021 , respectively .
−Removed: Company receives its active pharmaceutical ingredients from three main suppliers.
−Removed: These suppliers collectively accounted for 74 % of active
−Removed: pharmaceutical ingredient purchases during the year ended December 31, 2021, and 77 % during the year ended December 31, 2020.
+Added: The Company receives its active pharmaceutical ingredients from three main suppliers.
+Added: These suppliers collectively accounted for 61 %
+Added: of active pharmaceutical ingredient purchases during the year ended December 31, 2022, and 74 % during the year ended December 31, 2021.
SUBSEQUENT EVENTS
−Removed: January 2022, the Company issued 53,594 shares of common stock to Mark L.
−Removed: Baum, the Company’s Chief Executive Officer, upon the
−Removed: cashless exercise of options to purchase 125,000 shares at an exercise price of $ 2.40 per share.
−Removed: The Company withheld from Mr.
−Removed: shares as consideration for the cashless exercise and an additional 35,392 shares for payroll tax purposes.
−Removed: February 2022, 50,000 RSUs
−Removed: granted in February 2019 to Andrew R.
−Removed: Boll, the Company’s Chief Financial Officer, vested, and, 29,395
−Removed: shares the Company’s common stock were
−Removed: issued to Mr.
−Removed: Boll, net of 20,605
−Removed: shares of common stock withheld for payroll tax
−Removed: withholdings totaling $ 162 .
−Removed: February 2022, 50,000 RSUs
−Removed: granted in February 2019 to John P.
−Removed: Saharek, the Company’s President of ImprimisRx, vested, and, 24,077
−Removed: shares the Company’s common stock were
−Removed: issued to Mr.
−Removed: Saharek, net of 25,923
−Removed: shares of common stock withheld for payroll tax
−Removed: withholdings totaling $ 204 .
+Added: January 2023, 23,000 RSUs granted in January 2020 to Andrew R.
+Added: Boll, the Company’s Chief Financial Officer, vested, and 13,398 shares
+Added: the Company’s common stock were issued to Mr.
+Added: Boll, net of 9,602 shares of common stock withheld for payroll tax withholdings
+Added: totaling $ 142,000 .
+Added: January 2023, 88,000 RSUs granted in January 2020 to Mark L.
+Added: Baum, the Company’s Chief Executive Officer, vested, and 52,821 shares
+Added: the Company’s common stock were issued to Mr.
+Added: Baum, net of 35,179 shares of common stock withheld for payroll tax withholdings
+Added: totaling $ 519,000 .
+Added: of BR Loan and Fab 5 Acquisition - ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE
+Added: January 2023, the Company closed the Fab 5 Acquisition.
+Added: At the time of closing the Company made a one-time payment of $ 130,000,000 ,
+Added: with up to another $ 45,000,000 due in a milestone payment related to the timing of the commercial availability of TRIESENCE.
+Added: At closing the Company entered into a transition period, where Novartis will continue to sell the Fab 5 Products on the
+Added: Company’s behalf and transfer the net profit from the sale of the Fab 5 Products to the Company until the time the
+Added: Fab 5 Products at transferred to the Company.
+Added: Company funded the initial purchase price payable at closing of the Fab 5 Acquisition with (i) proceeds of a $ 59,750,000
+Added: principal amount borrowing pursuant to the BR Loan (see Note 13), which was drawn at closing of the Fab 5 Acquisition, along with cash on hand
+Added: (including cash provided by certain financing activities during 2022).
+Added: Overallotment
+Added: Exercise of 2027 Notes
+Added: January 2023, the Company issued an additional $ 5,250,000
+Added: aggregate principal amount of the 2027 Notes (see Note 13) upon the exercise in full of the underwriters’ option to purchase
+Added: the additional notes.
+Added: As of the closing of the issuance of the additional 2027 Notes, a total of $ 40,250,000
+Added: aggregate principal amount of the 2027 Notes have been issued.
Company has performed an evaluation of events occurring subsequent to December 31, 2022 through the filing date of this Annual Report
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.