2 unchanged sentences
CONDENSED CONSOLIDATED BALANCE SHEETS
+Added: September 30,
Current assets
5 unchanged sentences
Property, plant and equipment, net
−Removed: Capitalized software development costs, net
+Added: Capitalized software costs, net
Operating lease right-of-use assets
11 unchanged sentences
Finance lease obligations, net of current portion
−Removed: Loans payable, net of unamortized debt discount
+Added: Loans payable, net of current portion and unamortized debt discount
TOTAL LIABILITIES
1 unchanged sentence
STOCKHOLDERS’ EQUITY
−Removed: Common stock, $ 0.001 par value, 50,000,000 shares authorized, 27,069,978 and 26,902,763 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively
+Added: Common stock, $ 0.001 par value, 50,000,000 shares authorized, 27,074,307 and 26,902,763 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively
Additional paid-in capital
1 unchanged sentence
( 110,548,000 )
+Added: ( 95,407,000 )
TOTAL HARROW HEALTH STOCKHOLDERS’ EQUITY
2 unchanged sentences
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
−Removed: accompanying notes are an integral part of these unaudited condensed consolidated financial statements
+Added: The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
+Added: HARROW HEALTH, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
−Removed: Three Months Ended
−Removed: Six Months Ended
+Added: For the Three Months Ended
+Added: For the Nine Months Ended
+Added: September 30,
+Added: September 30,
Product sales, net
10 unchanged sentences
Total operating expenses
−Removed: Income from operations
+Added: (Loss) income from operations
+Added: ( 3,717,000 )
Other (expense) income:
37 unchanged sentences
Basic and diluted net loss per share of common stock
−Removed: Weighted average number of shares of common stock outstanding, basic and diluted
+Added: Weighted average number of shares of common stock outstanding, basic and
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
−Removed: the Three and Six Months Ended June 30, 2022 and 2021
−Removed: Preferred Stock
HARROW HEALTH, INC.
+Added: UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
+Added: the Three and Nine Months Ended September 30, 2022 and 2021
+Added: Preferred Stock
Noncontrolling
4 unchanged sentences
$ ( 77,400,000 )
−Removed: $ ( 355,000 )
Issuance of common stock in connection with:
Exercise of warrants
−Removed: Exercise of employee stock options
+Added: Exercise of employee stock-based options
Vesting of RSUs
−Removed: Shares withheld related to net share settlement of equity awards
+Added: Shares withheld related to net share settlement of
+Added: equity awards
( 3,228,000 )
11 unchanged sentences
( 10,589,000 )
−Removed: Balance at June 30, 2021
+Added: Balance at September 30, 2021
$ 104,551,000
6 unchanged sentences
Issuance of common stock in connection with:
−Removed: Exercise of employee stock options
+Added: Exercise of consultant stock-based options
+Added: Exercise of employee stock-based options
Vesting of RSUs
−Removed: Shares withheld related to net share settlement of equity awards
+Added: Shares withheld related to net share settlement of
+Added: equity awards
Stock-based compensation expense
2 unchanged sentences
( 15,141,000 )
−Removed: Balance at June 30, 2022
+Added: Balance at September 30, 2022
$ 111,738,000
1 unchanged sentence
$ ( 355,000 )
+Added: Preferred Stock
+Added: Harrow Health, Inc.
Noncontrolling
1 unchanged sentence
Stockholders’
−Removed: Balance at March 31, 2021
−Removed: $ 105,382,000
−Removed: $ ( 77,183,000 )
−Removed: Issuance of common stock in
−Removed: connection with:
−Removed: Exercise of warrants
−Removed: Exercise of employee stock options
−Removed: Vesting of RSUs
−Removed: Shares withheld related to
−Removed: net share settlement of equity awards
−Removed: ( 3,171,000 )
−Removed: ( 3,171,000 )
−Removed: ( 3,171,000 )
−Removed: Issuance of preferred shares,
−Removed: net of discount and issuance costs
−Removed: Redemption of preferred shares
+Added: Balance at June 30, 2021
$ 102,837,000
1 unchanged sentence
$ ( 355,000 )
−Removed: Payment of preferred dividends
+Added: Issuance of common stock in connection with:
+Added: Exercise of employee stock-based options
Stock-based compensation expense
2 unchanged sentences
( 8,328,000 )
−Removed: Balance at June 30, 2021
+Added: Balance at September 30, 2021
$ 104,551,000
1 unchanged sentence
$ ( 355,000 )
−Removed: Balance at March 31, 2022
+Added: Balance at June 30, 2022
$ 109,806,000
1 unchanged sentence
$ ( 355,000 )
−Removed: Issuance of common stock in
−Removed: connection with:
−Removed: Exercise of employee stock options
−Removed: Vesting of RSUs
−Removed: Shares withheld related to
−Removed: net share settlement of equity awards
+Added: Issuance of common stock in connection with:
+Added: Exercise of consultant stock-based options
+Added: Exercise of employee stock-based options
Stock-based compensation expense
2 unchanged sentences
( 6,464,000 )
−Removed: Balance at June 30, 2022
+Added: Balance at September 30, 2022
$ 111,738,000
2 unchanged sentences
accompanying notes are an integral part of these unaudited condensed consolidated financial statements
−Removed: CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
−Removed: For the Six Months Ended
+Added: HARROW HEALTH, INC.
+Added: UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
+Added: For the Nine Months Ended
+Added: September 30,
CASH FLOWS FROM OPERATING ACTIVITIES
1 unchanged sentence
$ ( 10,589,000 )
−Removed: Adjustments to reconcile net loss to net cash provided by operating activities:
−Removed: Depreciation and amortization
+Added: Adjustments to reconcile net loss to net cash provided by operating
+Added: Depreciation and amortization of property, plant and equipment
Amortization of intangible assets
6 unchanged sentences
Equity in losses of unconsolidated entities
+Added: Interest paid-in-kind from note receivable
Loss on early extinguishment of loan
4 unchanged sentences
( 1,532,000 )
+Added: ( 1,066,000 )
Prepaid expenses and other current assets
6 unchanged sentences
Investment in patent and trademark assets
+Added: Issuance of note receivable, Melt Pharmaceuticals
+Added: ( 12,592,000 )
Purchases of property, plant and equipment
( 1,719,000 )
−Removed: NET CASH (USED IN) PROVIDED BY INVESTING ACTIVITIES
+Added: ( 1,649,000 )
+Added: NET CASH USED IN INVESTING ACTIVITIES
+Added: ( 1,738,000 )
+Added: ( 4,489,000 )
CASH FLOWS FROM FINANCING ACTIVITIES
21 unchanged sentences
Cash paid for interest
−Removed: SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING
−Removed: AND FINANCING ACTIVITIES:
+Added: SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES:
+Added: Issuance of common stock upon vesting of RSUs
+Added: Purchase of intangible asset included in accounts payable and accrued expenses
Purchase of property, plant and equipment included in accounts payable and
accrued expenses
+Added: Insurance premium financed
Right-of-use assets obtained in exchange for new operating lease obligations
−Removed: accompanying notes are an integral part of these unaudited condensed consolidated financial statements
+Added: Melt accounts receivable to note receivable
+Added: The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
−Removed: the Three and Six Months Ended June, 2022 and 2021
+Added: the Three and Nine months ended September, 2022 and 2021
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
and Background
−Removed: (together with its subsidiaries, partially owned companies and royalty arrangements unless the context indicates or
−Removed: otherwise requires, the “Company” or “Harrow”) is an eyecare pharmaceutical company focused on the
−Removed: development, production, sale, and distribution of accessible and affordable innovative ophthalmic prescription medications.
+Added: (together with its subsidiaries, partially owned companies and royalty arrangements unless the context indicates or otherwise
+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.
Company owns non-controlling equity positions in Surface Ophthalmics, Inc.
11 unchanged sentences
adjustments) considered necessary for a fair presentation have been included.
−Removed: Operating results for the three and six months ended June
+Added: Operating results for the three and nine months ended September
30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022 or for any other period.
10 unchanged sentences
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
−Removed: following represents an update for the three and six months ended June 30, 2022 to the significant accounting policies described in the
−Removed: Company’s Annual Report on Form 10-K for the year ended December 31, 2021.
+Added: following represents an update for the three and nine months ended September 30, 2022 to the significant accounting policies described
+Added: in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.
Uncertainties and Liquidity
4 unchanged sentences
of operations.
−Removed: to shifts in the Company’s strategic plans to further focus on growing the Company’s ImprimisRx business and suspension of
−Removed: activities related to starting up development-stage pharmaceutical companies, along with changes to the Company’s organizational
−Removed: and internal reporting structure, beginning in January 2022 management no longer evaluates the Company’s business in two segments
−Removed: and instead focuses on the performance of the business as a single operating business.
+Added: a result of shifts in the Company’s strategic plans to further focus on growing the Company’s ImprimisRx business and
+Added: suspension of activities related to starting up development-stage pharmaceutical companies, along with changes to the
+Added: Company’s organizational and internal reporting structure, beginning in January 2022, management no longer evaluates the
+Added: Company’s business in two segments and instead focuses on the performance of the business as a single operating
and Diluted Net Loss per Common Share
5 unchanged sentences
Common equivalent shares (using the treasury stock method)
−Removed: from stock options, unvested RSUs and warrants were 5,646,672 and 4,121,398 at June 30, 2022 and 2021, respectively.
−Removed: Included in the
−Removed: basic and diluted net loss per share calculation were RSUs awarded to directors that had vested, but the issuance and delivery of the
−Removed: shares are deferred until the director resigns.
−Removed: The number of shares underlying vested RSUs at June 30, 2022 and 2021 was 287,049 and
−Removed: 235,973 , respectively.
−Removed: following table shows the computation of basic net loss per share of common stock for the three and six months ended June 30, 2022 and
+Added: from stock options, unvested RSUs and warrants were 5,622,997 and 5,657,046 at September 30, 2022 and 2021, respectively.
+Added: the basic and diluted net loss per share calculation were RSUs awarded to directors that had vested, but the issuance and delivery of
+Added: the shares are deferred until the director resigns.
+Added: The number of shares underlying vested RSUs at September 30, 2022 and 2021 was 303,454
+Added: and 258,117 , respectively.
+Added: following table shows the computation of basic net loss per share of common stock for the three and nine months ended September 30, 2022
SCHEDULE OF BASIC AND DILUTED EARNINGS PER COMMON SHARE
−Removed: June 30, 2022
−Removed: June 30, 2021
−Removed: June 30, 2022
−Removed: June 30, 2021
−Removed: Three Months Ended
−Removed: Six Months Ended
−Removed: June 30, 2022
−Removed: June 30, 2021
−Removed: June 30, 2022
−Removed: June 30, 2021
+Added: For the Three Months Ended
+Added: For the Nine Months Ended
+Added: September 30,
+Added: September 30,
Numerator – net loss attributable to common stockholders
3 unchanged sentences
$ ( 10,589,000 )
−Removed: Denominator – weighted average
−Removed: number of shares outstanding, basic and diluted
Denominator – weighted average number of shares outstanding, basic and
−Removed: Net loss per share of common stock, basic and diluted
+Added: Net loss per share, basic and diluted
in Eton Pharmaceuticals, Inc .
−Removed: of June 30, 2022, the Company owned 1,982,000 shares of Eton common stock, which represents less than 10 % of the equity interests of
−Removed: At June 30, 2022, the fair market value of Eton’s common stock was $ 2.62 per share.
−Removed: In accordance with the Accounting Standards
−Removed: Update (“ASU”) 2016-01, Financial Instruments-Overall (Subtopic 825-10):
−Removed: Recognition and Measurement of Financial Assets
−Removed: and Financial Liabilities , the Company recorded an unrealized investment loss from its Eton common stock position of $ 3,449,000 and
−Removed: $ 3,310,000 , and $ 3,584,000 and $ 6,419,000 during the three and six months ended June 30, 2022 and 2021, respectively, related to the
−Removed: change in fair market value of its investment in Eton during the measurement period.
−Removed: As of June 30, 2022, the fair market value of the
−Removed: Company’s investment in Eton was $ 5,193,000 .
+Added: of September 30, 2022, the Company owned 1,982,000 shares of Eton common stock, which represents less than 10 % of the equity interests
+Added: At September 30, 2022, the fair market value of Eton’s common stock was $ 2.10 per share.
+Added: In accordance with the Accounting
+Added: Standards Update (“ASU”) 2016-01, Financial Instruments-Overall (Subtopic 825-10):
+Added: Recognition and Measurement of Financial
+Added: Assets and Financial Liabilities , the Company recorded an unrealized investment loss from its Eton common stock position of $ 1,031,000
+Added: and $ 4,341,000 , and $ 2,220,000 and $ 8,639,000 during the three and nine months ended September 30, 2022 and 2021, respectively, related
+Added: to the change in fair market value of its investment in Eton during the measurement period.
+Added: As of September 30, 2022, the fair market
+Added: value of the Company’s investment in Eton was $ 4,162,000 .
in Melt Pharmaceuticals, Inc.
– Related Party
−Removed: Company owns 3,500,000 shares of common stock of Melt (representing approximately 46 % of the equity interests as of June 30, 2022) of
+Added: Company owns 3,500,000 shares of common stock of Melt (representing approximately 46 % of the equity interests as of September 30, 2022).
The Company analyzes its investment in Melt and related agreements on a regular basis to evaluate its position of variable interests
7 unchanged sentences
of equity losses in Melt since its deconsolidation in 2019.
−Removed: As of June 30, 2022 and at the time of entering into the Melt Loan Agreement
+Added: As of September 30, 2022 and at the time of entering into the Melt Loan Agreement
(see Note 4), the Company owned 100 % of Melt’s indebtedness.
6 unchanged sentences
requirements to advance funds to Melt.
−Removed: following table summarizes the Company’s investments in Melt as of June 30, 2022:
−Removed: OF INVESTMENT
−Removed: Share of Equity Method
−Removed: Paid-in -Kind
+Added: following table summarizes the Company’s investments in Melt as of September 30, 2022:
+Added: SCHEDULE OF INVESTMENT
+Added: Share of Equity
+Added: Method Losses
Contributions
−Removed: Carrying value
+Added: $ ( 5,810,000 )
+Added: ( 11,403,000 )
+Added: ( 1,995,000 )
+Added: $ ( 17,213,000 )
+Added: $ ( 1,995,000 )
Note 4 for more information and related party disclosure regarding Melt.
2 unchanged sentences
Company owns 3,500,000 common shares of Surface (representing approximately 20 % of Surface’s equity interests following the closing
−Removed: of a round of financing completed by Surface in July 2021) of Surface and uses the equity method of accounting for this investment, as
+Added: of a round of financing completed by Surface in July 2021) and uses the equity method of accounting for this investment, as
management has determined that the Company has the ability to exercise significant influence over the operating and financial decisions
7 unchanged sentences
Company has no other investments in Surface.
−Removed: following table summarizes the Company’s investment in Surface as of June 30, 2022:
+Added: following table summarizes the Company’s investment in Surface as of September 30, 2022:
SCHEDULE OF INVESTMENT
14 unchanged sentences
method investments and note receivable.
−Removed: At June 30, 2022 and December 31, 2021, no indicators of impairment existed.
+Added: At September 30, 2022 and December 31, 2021, no indicators of impairment existed.
Company accounts for contracts with customers in accordance with Accounting Standards Codification (“ASC”) 606, Revenues
from Contracts with Customers .
−Removed: The Company has four primary streams of revenue:
−Removed: (1) revenue recognized from sales of products
−Removed: through its pharmacy and outsourcing facility and sales of branded products to wholesalers through a third-party logistics
−Removed: (“3PL”) facility, (2) revenue recognized from a commission agreement with a third party, (3) revenue recognized from
−Removed: transfer of acquired product profit, and (4) revenue recognized from intellectual property licenses and asset purchase
−Removed: Company sells prescription drugs directly through its pharmacy, outsourcing facility and 3PL partner.
+Added: The Company has three primary streams of revenue:
+Added: (1) revenue recognized from sales of products through
+Added: its pharmacy and outsourcing facility and sales of branded products to wholesalers through a third-party logistics (“3PL”)
+Added: partner, (2) revenue recognized from a commission agreement with a third party, and (3) revenue recognized from intellectual property
+Added: licenses and asset purchase agreements.
+Added: Company sells prescription medications directly through its pharmacy, outsourcing facility and 3PL partner.
Revenue from the Company’s
7 unchanged sentences
A contract is deemed to exist when the customer places an order through receipt of a prescription,
−Removed: via an online order or via receipt of a purchase order from the Company.
+Added: via an online order or via receipt of a purchase order from a customer.
For branded products, orders are received through the Company’s
1 unchanged sentence
the performance obligations in the contract:
−Removed: Obligations for fulfillment of the Company’s contracts consist of delivering the
−Removed: product to the customer at their specified destination.
−Removed: ASU 2016-10 was issued in April 2016 and amended ASC 606 for shipping and handling
−Removed: activities as follows:
−Removed: If the customer takes control of the goods after shipment, shipping and handling activities would always be considered
−Removed: a fulfillment activity and not treated as a separate performance obligation.
−Removed: If the customer takes control of the goods before shipment,
−Removed: entities must make an accounting policy election to treat shipping and handling activities as either a fulfillment cost or as a separate
+Added: Obligations for fulfillment of the Company’s
+Added: contracts consist of delivering the product to customers at their specified destination.
+Added: ASU 2016-10 was issued in April 2016 and amended ASC 606 for shipping and handling activities
+Added: If the customer takes control of the goods after shipment, shipping and handling
+Added: activities would always be considered a fulfillment activity and not treated as a separate
performance obligation.
−Removed: The Company has elected to treat its shipping and handling activities as a fulfillment cost.
+Added: If the customer takes control of the goods before shipment, entities
+Added: must make an accounting policy election to treat shipping and handling activities as either
+Added: a fulfillment cost or as a separate performance obligation.
+Added: The Company has elected to treat
+Added: its shipping and handling activities as a fulfillment cost.
the transaction price:
−Removed: The transaction price is based on an amount that reflects the consideration to which the Company expects
−Removed: to be entitled, net of accruals for estimated rebates, wholesaler chargebacks, discounts and other deductions (collectively, sales
−Removed: deductions) and an estimate for returns and replacements established at the time of sale.
−Removed: The Company utilizes the services of a
−Removed: third-party professional services firm to estimate rebates and chargebacks associated with sales of its branded products.
−Removed: of promised goods is satisfied within a year, and therefore there are no significant financing components.
−Removed: There is no non-cash consideration
−Removed: related to product sales.
−Removed: the transaction price to the performance obligations in the contract:
−Removed: Because there is only one performance obligation for product
−Removed: sales, no allocation is necessary.
+Added: The transaction price is based on an amount that reflects the
+Added: consideration to which the Company expects to be entitled, net of accruals for estimated
+Added: rebates, wholesaler chargebacks, discounts and other deductions (collectively, sales deductions)
+Added: and an estimate for returns and replacements established at the time of sale.
+Added: utilizes the services of a third-party professional services firm to estimate rebates and
+Added: chargebacks associated with sales of its branded products.
+Added: The transfer of promised goods
+Added: is satisfied within a year, and therefore there are no significant financing components.
+Added: There is no non-cash consideration related to product sales.
+Added: transaction price to the performance obligations in the contract:
+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:
17 unchanged sentences
recognize the associated revenue.
−Removed: On a quarterly basis, the Seller invoices the Company for all credits and reimbursements (“Chargebacks”)
+Added: On a quarterly basis, the Seller invoiced the Company for all credits and reimbursements (“Chargebacks”)
made to customers related to the products.
−Removed: The Company uses historical actual experience to estimate Chargebacks associated with the
+Added: The Company used historical actual experience to estimate Chargebacks associated with the
net profit transferred.
25 unchanged sentences
recognized on a straight-line basis over the applicable term.
−Removed: disaggregated by revenue source for the three and six months ended June 30, 2022 and 2021 consists of the following:
−Removed: OF DISAGGREGATED REVENUE
−Removed: the Three Months Ended
−Removed: the Six Months Ended
+Added: disaggregated by revenue source for the three and nine months ended September 30, 2022 and 2021 consists of the following:
+Added: SCHEDULE OF DISAGGREGATED REVENUE
+Added: For the Three Months Ended
+Added: For the Nine Months Ended
+Added: September 30,
+Added: September 30,
+Added: Product sales, net
+Added: Commission revenues
Transfer of profits
−Removed: revenue and customer deposits at June 30, 2022 and December 31, 2021 were $ 83,000 and $ 16,000 , respectively.
−Removed: All deferred revenue and
−Removed: customer deposit amounts at December 31, 2021 were recognized as revenue during the six months ended June 30, 2022.
+Added: License revenues
+Added: Total revenues
+Added: revenue and customer deposits at September 30, 2022 and December 31, 2021 were $ 115,000 and $ 16,000 , respectively.
+Added: All deferred revenue
+Added: and customer deposit amounts at December 31, 2021 were recognized as revenue during the nine months ended September 30, 2022.
INVESTMENT IN, AND NOTE RECEIVABLE FROM MELT PHARMACEUTICALS, INC.
9 unchanged sentences
related activities, and Melt is required to pay the Company a monthly amount of $ 10,000 .
−Removed: the three and six months ended June 30, 2022, the Company recorded $ 40,000 and $ 70,000 , respectively, due from Melt for reimbursable
+Added: the three and nine months ended September 30, 2022, the Company recorded $ 30,000 and $ 100,000 , respectively, due from Melt for reimbursable
expenses and amounts payable pursuant to the Melt MSA, which are included in prepaid expenses and other current assets in the accompanying
condensed consolidated balance sheets.
−Removed: As of June 30, 2022 and December 31, 2021, the Company was
−Removed: due $ 109,000 and $ 48,000 , respectively, from Melt for reimbursable expenses and amounts due under the Melt MSA.
−Removed: Melt did not make any
−Removed: payments to the Company during the three and six months ended June 30, 2022.
+Added: As of September 30, 2022 and December 31, 2021, the Company
+Added: was due $ 139,000 and $ 48,000 , respectively, from Melt for reimbursable expenses and amounts due under the Melt MSA.
+Added: Melt did not make
+Added: any payments to the Company during the three and nine months ended September 30, 2022.
Company’s Chief Executive Officer, Mark L.
6 unchanged sentences
SCHEDULE OF CONDENSED INCOME STATEMENT
−Removed: For the Six Months Ended June 30,
+Added: For the Nine Months Ended
+Added: September 30,
Revenues, net
5 unchanged sentences
unaudited condensed balance sheet information of Melt is summarized below:
−Removed: OF CONDENSED BALANCE SHEET
−Removed: At December 31,
+Added: SUMMARY OF CONDENSED BALANCE SHEET
+Added: September 30,
Current assets
6 unchanged sentences
Note Receivable
−Removed: September 1, 2021, the Company entered into a loan and security agreement in the principal amount of $ 13,500,000 (the “Melt Loan
−Removed: Agreement”), as lender, with Melt, as borrower.
−Removed: Amounts borrowed under the Melt Loan Agreement bear interest at 12.50 % per annum,
−Removed: which interest can be paid in-kind at the option of Melt until the maturity date.
−Removed: The Melt Loan Agreement permits Melt to pay interest
−Removed: only on the principal amount loaned thereunder through the term and all amounts owed will be due and payable on September 1, 2022.
−Removed: 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: September 1, 2021, the Company entered into a loan and security agreement in the principal amount of $ 13,500,000
+Added: (the “Melt Loan Agreement”), as lender, with Melt, as borrower.
+Added: Amounts borrowed under the Melt Loan Agreement bear
+Added: interest at 12.50 %
+Added: per annum, which interest can be paid in-kind at the option of Melt until the maturity date.
+Added: The Melt Loan Agreement permits Melt to
+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,
+Added: the “Amendments”) to the Melt Loan Agreement.
+Added: The Amendments (i) extended the maturity date of the Melt Loan Agreement
+Added: to June 1, 2023, which can be extended further to September 1, 2026 upon Melt completing a qualifying financing of a minimum amount
+Added: of $ 10,000,000
+Added: from third-party investors, (ii) added conditions related to minimum cash amounts following a qualifying financing, and (iii)
+Added: clarified the definition of material adverse effects.
+Added: Melt may elect to prepay all, but not less than all, of the amounts owed prior
+Added: to the maturity 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
7 unchanged sentences
by 3 % per annum.
−Removed: In April 2022, the Company entered into a First Amendment (the “Amendment”) to the Melt Loan Agreement.
−Removed: The Amendment, the effectiveness of which is subject to Melt consummating a qualifying financing of a minimum amount of $ 15,000,000 from
−Removed: third-party investors by August 31, 2022, added conditions related to minimum cash amounts, clarified the definition of material adverse
−Removed: effects and extended the maturity date to September 1, 2026.
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 $ 908,000 for amounts owed to the Company for reimbursable expenses and amounts due under the Melt
+Added: net funds received by Melt excluded $ 908,000 owed to the Company for reimbursable expenses and amounts due under the Melt
MSA prior to the effective date of the note receivable.
+Added: As of September 30, 2022 and December 31, 2021, $ 15,495,000 and $ 14,076,000 ,
+Added: respectively, in principal balance of the Melt Loan Agreement is payable to the Company.
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 June 30, 2022, the Company owned 3,500,000 shares of Surface common stock.
+Added: of September 30, 2022, the Company owned 3,500,000 shares of Surface common stock.
Company directors Richard L.
5 unchanged sentences
SUMMARY OF CONDENSED INCOME STATEMENT
−Removed: For the Six Months Ended June 30,
+Added: September 30,
Revenues, net
6 unchanged sentences
SUMMARY OF CONDENSED BALANCE SHEET
−Removed: At December 31,
+Added: September 30,
Current assets
3 unchanged sentences
Total liabilities and stockholders’ equity
−Removed: are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, branded commercial pharmaceutical
−Removed: products, including those held at a 3PL, related laboratory supplies and active pharmaceutical ingredients.
−Removed: The composition of inventories
−Removed: as of June 30, 2022 and December 31, 2021 was as follows:
+Added: are comprised of finished compounded formulations, over-the-counter and prescription retail pharmacy products, branded commercial
+Added: pharmaceutical products, including those held at the Company’s 3PL partner, related laboratory supplies and active
+Added: pharmaceutical ingredients.
+Added: The composition of inventories as of September 30, 2022 and December 31, 2021 was as follows:
SCHEDULE OF INVENTORIES
+Added: September 30,
Raw materials
3 unchanged sentences
PREPAID EXPENSES AND OTHER CURRENT ASSETS
−Removed: expenses and other current assets at June 30, 2022 and December 31, 2021 consisted of the following:
+Added: expenses and other current assets at September 30, 2022 and December 31, 2021 consisted of the following:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
+Added: September 30,
Prepaid insurance
+Added: Prepaid computer software licenses and related expenses
Due from Melt Pharmaceuticals
3 unchanged sentences
PROPERTY, PLANT AND EQUIPMENT
−Removed: plant and equipment at June 30, 2022 and December 31, 2021 consisted of the following:
+Added: plant and equipment at September 30, 2022 and December 31, 2021 consisted of the following:
SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT
+Added: September 30,
Property, plant and equipment, net:
8 unchanged sentences
plant and equipment, net
−Removed: the three and six months ended June 30, 2022, depreciation related to the property, plant and equipment was $ 381,000 and $ 757,000 , respectively,
−Removed: compared to $ 361,000 and $ 797,000 during the same periods in 2021, respectively.
+Added: the three and nine months ended September 30, 2022, depreciation related to the property, plant and equipment was $ 171,000 and $ 928,000 ,
+Added: respectively, compared to $ 410,000 and $ 1,202,000 during the same periods in 2021, respectively.
CAPITALIZED SOFTWARE DEVELOPMENT COSTS
−Removed: software development costs at June 30, 2022 and December 31, 2021 consisted of the following:
−Removed: SCHEDULE OF FINITE LIVED INTANGIBLE ASSETS
−Removed: Capitalized internal-use software development costs
−Removed: Acquired third-party software license for internal-use
−Removed: Total gross capitalized software for internal-use
+Added: software development costs at September 30, 2022 and December 31, 2021 consisted of the following:
+Added: SCHEDULE OF CAPITALIZED SOFTWARE DEVELOPMENT COSTS
+Added: Capitalized internal-use software development
+Added: Acquired third-party software
+Added: license for internal-use
+Added: Total gross capitalized software
+Added: for internal-use
Accumulated amortization
−Removed: Capitalized internal-use software in process
−Removed: finite lived intangible assets net
−Removed: Company recorded amortization expense of $ 43,000 and
−Removed: $ 86,000 related
−Removed: to capitalized software development costs during the three and six months ended June 30, 2022, respectively, and $ 51,000 and
−Removed: $ 79,000 during
−Removed: the same periods in 2021, respectively.
+Added: Capitalized internal-use software
+Added: Capitalized software costs, net
+Added: Company recorded amortization expense of $ 76,000 and $ 162,000 related to capitalized software development costs during the three and
+Added: nine months ended September 30, 2022, respectively, and $ 22,000 and $ 73,000 during the same periods in 2021, respectively.
INTANGIBLE ASSETS AND GOODWILL
−Removed: Company’s intangible assets at June 30, 2022 consisted of the following:
−Removed: OF INTANGIBLE ASSETS
−Removed: Periods (in years)
+Added: Company’s intangible assets at September 30, 2022 consisted of the following:
+Added: SCHEDULE OF INTANGIBLE ASSETS
$ ( 140,000 )
Acquired NDAs
+Added: ( 1,023,000 )
Customer relationships
2 unchanged sentences
$ ( 1,930,000 )
−Removed: expense for intangible assets for the three and six months ended June 30, 2022 and 2021 was as follows:
−Removed: OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
−Removed: Three Months Ended
−Removed: Six Months Ended
+Added: expense for intangible assets for the three and nine months ended September 30, 2022 and 2021 was as follows:
+Added: SCHEDULE OF AMORTIZATION EXPENSES FOR INTANGIBLE ASSETS
+Added: For the Three Months Ended
+Added: For the Nine Months Ended
Acquired NDAs
1 unchanged sentence
Amortization of intangible
−Removed: future amortization expense for the Company’s intangible assets at June 30, 2022 is as follows:
−Removed: OF ESTIMATED FUTURE AMORTIZATION EXPENSE
+Added: future amortization expense for the Company’s intangible assets at September 30, 2022 is as follows:
+Added: SCHEDULE OF ESTIMATED FUTURE AMORTIZATION EXPENSE
Remainder of 2022
1 unchanged sentence
ACCOUNTS PAYABLE AND ACCRUED EXPENSES
−Removed: payable and accrued expenses at June 30, 2022 and December 31, 2021 consisted of the following:
−Removed: OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
+Added: payable and accrued expenses at September 30, 2022 and December 31, 2021 consisted of the following:
+Added: SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES
+Added: September 30,
Accounts payable
+Added: Accrued insurance premium
+Added: Accrued IHEEZO milestone payment
Other accrued expenses
1 unchanged sentence
Total accounts payable and accrued expenses
+Added: Company financed all insurance policies for the policy term of August 17, 2022 through August 16, 2023.
+Added: The financing agreement has an
+Added: interest rate of 4.13 % per annum and requires eight monthly payments of $ 114,000 .
Senior Notes Due 2026
−Removed: April 2021, the Company closed an offering of $ 50,000,000
−Removed: aggregate principal amount of 8.625% senior notes
−Removed: due April 2026, and in May 2021 issued an additional $ 5,000,000
−Removed: of such notes pursuant to the full exercise of
−Removed: the underwriters’ option to purchase additional notes (collectively, the “April Notes”).
−Removed: The April Notes were sold
−Removed: to investors at a par value of $ 25.00
−Removed: per April Note and the offering resulted in net
−Removed: proceeds to the Company of approximately $ 51,909,000
−Removed: after deducting underwriting discounts and commissions
−Removed: and expenses of $ 3,091,000 .
−Removed: In June 2021, in a further issuance of the April Notes, the Company sold an additional $ 20,000,000
−Removed: aggregate principal amount of such notes (the
−Removed: “June Notes,” and together with the April Notes, the “Notes”), at a price of $ 25.75
−Removed: per June Note, with interest of $ 278,000
−Removed: on the June Notes being accrued from April 20,
−Removed: 2021 as of the date of issuance.
−Removed: The June offering resulted in net proceeds to the Company of approximately $ 19,164,000
−Removed: after deducting underwriting discounts and commissions
+Added: April 2021, the Company closed an offering of $ 50,000,000 aggregate principal amount of 8.625% senior notes due April 2026, and in May
+Added: 2021 issued an additional $ 5,000,000 of such notes pursuant to the full exercise of the underwriters’ option to purchase additional
+Added: notes (collectively, the “April Notes”).
+Added: The April Notes were sold to investors at a par value of $ 25.00 per April Note and
+Added: the offering resulted in net proceeds to the Company of approximately $ 51,909,000 after deducting underwriting discounts and commissions
and expenses of $ 3,091,000 .
−Removed: and a premium on note issuance of $ 322,000 .
−Removed: The June Notes are treated as a single series with the April Notes under the indenture governing the April Notes, dated as of April 20,
−Removed: 2021, and have the same terms as the April Notes (other than the initial offering price and issue date).
−Removed: Notes are senior unsecured obligations of the Company and rank equally in right of payment with all of our other existing and future
−Removed: senior unsecured and unsubordinated indebtedness.
−Removed: The Notes are effectively subordinated in right of payment to all of the Company’s
−Removed: existing and future secured indebtedness and structurally subordinated to all existing and future indebtedness of the Company’s
−Removed: subsidiaries, including trade payables.
−Removed: The Notes bear interest at a rate of 8.625 %
−Removed: Interest on the Notes is payable quarterly in arrears on January 31, April 30, July 31 and October 31 of each year, commencing
−Removed: on July 31, 2021.
+Added: In June 2021, in a further issuance of the April Notes, the Company sold an additional $ 20,000,000 aggregate
+Added: principal amount of such notes (the “June Notes,” and together with the April Notes, the “Notes”), at a price
+Added: of $ 25.75 per June Note, with interest of $ 278,000 on the June Notes being accrued from April 20, 2021 as of the date of issuance.
+Added: June offering resulted in net proceeds to the Company of approximately $ 19,164,000 after deducting underwriting discounts and commissions
+Added: and expenses of $ 1,158,000 and a premium on note issuance of $ 322,000 .
+Added: The June Notes are treated as a single series with the April Notes
+Added: under the indenture governing the April Notes, dated as of April 20, 2021, and have the same terms as the April Notes (other than the
+Added: initial offering price and issue date).
+Added: T he Notes are senior unsecured obligations of the
+Added: Company and rank equally in right of payment with all of our other existing and future senior unsecured and unsubordinated indebtedness.
+Added: The Notes are effectively subordinated in right of payment to all of the Company’s existing and future secured indebtedness and
+Added: structurally subordinated to all existing and future indebtedness of the Company’s subsidiaries, including trade payables.
+Added: Notes bear interest at a rate of 8.625 % per annum.
+Added: Interest on the Notes is payable quarterly in arrears on January 31, April 30, July
+Added: 31 and October 31 of each year, commencing on July 31, 2021.
The Notes will mature on April 30, 2026 .
−Removed: The issuance costs were recorded as
−Removed: a debt discount and are being amortized as interest expense, net of the amortization of the premium on note issuance, over the term of
−Removed: the Notes using the effective interest rate method.
+Added: costs were recorded as a debt discount and are being amortized as interest expense, net of the amortization of the premium on note issuance,
+Added: over the term of the Notes using the effective interest rate method.
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 ,
−Removed: plus a make-whole amount, if any, plus accrued and unpaid interest to, but excluding, the date of redemption.
−Removed: The Company may redeem
−Removed: the Notes for cash in whole or in part at any time at our option on or after February 1, 2026 and prior to maturity, at a price equal
−Removed: to 100% of their principal amount, plus accrued and unpaid interest to, but excluding, the date of redemption.
−Removed: On and after any redemption
−Removed: date, interest will cease to accrue on the redeemed Notes.
−Removed: expense related to the Notes totaled $ 1,812,000 and
−Removed: $ 3,622,000 for
−Removed: the three and six months ended June 30, 2022, respectively, and $ 1,466,000 during
−Removed: the three and six months ended June 30, 2021, and included amortization of debt issuance costs and discount of $ 195,000 and
−Removed: $ 388,000 for
−Removed: three and six months ended June 30, 2022, respectively, and $ 192,000 during
−Removed: the three and six months ended June 30, 2021.
−Removed: June 30, 2022, future minimum payments under the Company’s debt were as follows:
−Removed: OF FUTURE MINIMUM PAYMENTS
+Added: 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
+Added: to, but excluding, the date of redemption.
+Added: The Company may redeem the Notes for cash in whole or in part at any time at our option on
+Added: 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: to, but excluding, the date of redemption.
+Added: On and after any redemption date, interest will cease to accrue on the redeemed Notes.
+Added: expense related to the Notes totaled $ 1,814,000 and $ 5,436,000 for the three and nine months ended September 30, 2022, respectively,
+Added: and $ 1,464,000 and $ 2,930,000 during the three and nine months ended September 30, 2021, respectively, and included amortization of debt
+Added: issuance costs and discount of $ 197,000 and $ 585,000 for three and nine months ended September 30, 2022, respectively, and $ 197,000 and
+Added: $ 389,000 during the three and nine months ended September 30, 2021, respectively.
+Added: September 30, 2022, future minimum payments under the Company’s debt were as follows:
+Added: OF FUTURE MINIMUM PAYMENT UNDER NOTES PAYABLES
Remainder of 2022
6 unchanged sentences
Notes payable, net of unamortized discount
−Removed: Company leases office and laboratory space under non-cancelable operating leases listed below.
−Removed: These lease agreements have remaining
−Removed: terms between one
−Removed: years and contain various clauses for renewal
−Removed: at the Company’s option.
−Removed: operating lease for 5,789
−Removed: square feet of office space in Carlsbad,
−Removed: California, which commenced in January 2022 and will expire in July
+Added: Company leases office and laboratory space under the non-cancelable operating leases listed below.
+Added: These lease agreements have
+Added: remaining terms between one
+Added: 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
+Added: in January 2022 and will expire in July 2027 .
operating lease for 35,326
−Removed: square feet of lab, warehouse and office
−Removed: space in Ledgewood, New Jersey that expires in July
−Removed: 2026 , with an option to extend the term for
−Removed: two additional five-year periods.
−Removed: This includes an amendment, which was made effective July 2020, that extended the term of
−Removed: the original lease and added 1,400
−Removed: of additional square footage to the lease,
−Removed: and another amendment entered into in May 2021 that extended the term of the lease to July 2027 and added 8,900
+Added: 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
+Added: extend the term of the original lease and add 1,400
+Added: of additional square footage to the lease, and amended again in May 2021 to extend the term of the lease to July
+Added: 2027 and add 8,900
square feet of space.
−Removed: operating lease for 5,500
−Removed: square feet of office space in Nashville,
−Removed: Tennessee that expires in December
−Removed: 2024 , with an
−Removed: option to extend the term for two additional five-year periods .
−Removed: operating lease for 11,552
−Removed: square feet of lab and office space in Nashville,
−Removed: Tennessee which commenced in June 2022 and will expire in June
−Removed: June 30, 2022, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases
−Removed: held by the Company were 6.61 %
−Removed: and 11.21 years,
−Removed: respectively.
−Removed: the three and six months ended June 30, 2022, cash paid for amounts included for the operating lease liabilities was $ 207,000
−Removed: and $ 373,000 ,
−Removed: respectively, and $ 251,000 and
−Removed: $ 502,000 during
−Removed: the same periods in 2021, respectively.
−Removed: During the three and six months ended June 30, 2022, the Company recorded operating lease expense
−Removed: of $ 262,000 and
−Removed: respectively, which is included in selling, general and administrative expenses.
−Removed: lease payments under operating leases as of June 30, 2022 were as follows :
−Removed: OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES
+Added: operating lease for 5,500 square feet of office space in Nashville, Tennessee that expires
+Added: in December 2024 , with 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
+Added: commenced in June 2022 and expires in June 2027 .
+Added: September 30, 2022, the weighted average incremental borrowing rate and the weighted average remaining lease term for the operating leases
+Added: held by the Company were 6.62 % and 10.99 years, respectively.
+Added: the three and nine months ended September 30, 2022, cash paid for amounts included for the operating lease liabilities was $ 249,000 and
+Added: $ 622,000 , respectively, and $ 250,000 and $ 752,000 during the same periods in 2021, respectively.
+Added: During the three and nine months ended
+Added: September 30, 2022, the Company recorded operating lease expense of $ 309,000 and $ 809,000 , respectively, which is included in selling,
+Added: general and administrative expenses.
+Added: lease payments under operating leases as of September 30, 2022 were as follows :
+Added: SCHEDULE OF FUTURE LEASE PAYMENT UNDER OPERATING LEASES
Remainder of 2022
5 unchanged sentences
Operating lease liabilities, net of current portion
−Removed: the six months ended June 30, 2022, the Company paid all amounts owed under its finance lease and no future payments are due related
−Removed: to finance leases.
+Added: the nine months ended September 30, 2022, the Company repaid all remaining amounts owed under its finance lease and no future payments
+Added: are due related to finance leases.
STOCKHOLDERS’ EQUITY AND STOCK-BASED COMPENSATION
−Removed: June 30, 2022 and December 31, 2021, the Company had 5,000,000 shares of preferred stock, $ 0.001 par value, authorized and no shares
+Added: September 30, 2022 and December 31, 2021, the Company had 5,000,000 shares of preferred stock, $ 0.001 par value, authorized and no shares
of preferred stock issued and outstanding.
−Removed: the six months ended June 30, 2022, the Company issued 53,594 shares of common stock to Mark L.
−Removed: Baum, the Company’s Chief Executive
−Removed: Officer, upon the cashless exercise of options to purchase 125,000 shares at an exercise price of $ 2.40 per share.
−Removed: The Company withheld
−Removed: Baum 36,014 shares as consideration for the cashless exercise and an additional 35,392 shares for payroll tax obligations totaling
−Removed: the six months ended June 30, 2022, the Company issued 3,000 shares of common stock and received net proceeds of $ 7,000 upon the exercise
−Removed: of options to purchase 3,000 shares of common stock with exercise prices between $ 1.70 to $ 3.95 per share.
−Removed: the six months ended June 30, 2022, 50,000 RSUs granted in February 2019 to Andrew R.
−Removed: Boll, the Company’s Chief Financial Officer,
−Removed: vested, and in February 2022, the Company issued 29,395 shares of common stock to Mr.
−Removed: Boll, net of 20,605 shares of common stock withheld
+Added: the nine months ended September 30, 2022, the Company issued 53,594 shares of common stock to Mark L.
+Added: Baum, the Company’s Chief
+Added: Executive Officer, upon the cashless exercise of options to purchase 125,000 shares at an exercise price of $ 2.40 per share.
+Added: withheld from Mr.
+Added: Baum 36,014 shares as consideration for the cashless exercise and an additional 35,392 shares for payroll tax obligations
+Added: totaling $ 295,000 .
+Added: the nine months ended September 30, 2022, the Company issued 4,054 shares of common stock to consultants 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
+Added: the cashless exercise.
+Added: the nine months ended September 30, 2022, the Company issued 3,275 shares of common stock and received net proceeds of $ 7,000 upon the
+Added: exercise of options to purchase 3,275 shares of common stock with exercise prices between $ 1.70 to $ 3.95 per share.
+Added: the nine months ended September 30, 2022, 50,000 RSUs granted in February 2019 to Andrew R.
+Added: Boll, the Company’s Chief Financial
+Added: Officer, vested, and in February 2022, the Company issued 29,395 shares of common stock to Mr.
+Added: Boll, net of 20,605 shares of common stock
+Added: withheld for payroll tax withholdings totaling $ 162,000 .
+Added: the nine months ended September 30, 2022, 50,000 RSUs granted in February 2019 to John P.
+Added: Saharek, the President of ImprimisRx, vested,
+Added: and in February 2022, the Company issued 24,077 shares of common stock to Mr.
+Added: Saharek, net of 25,923 shares of common stock withheld
for payroll tax withholdings totaling $ 204,000 .
−Removed: the six months ended June 30, 2022, 50,000 RSUs granted in February 2019 to John P.
−Removed: Saharek, the President of ImprimisRx, vested, and
−Removed: in February 2022, the Company issued 24,077 shares of common stock to Mr.
−Removed: Saharek, net of 25,923 shares of common stock withheld for
−Removed: payroll tax withholdings totaling $ 204,000 .
−Removed: the six months ended June 30, 2022, 35,000 RSUs granted in February 2019 vested, and in February 2022, the Company issued 20,298 shares
−Removed: of common stock, net of 14,702 shares of common stock withheld for payroll tax withholdings totaling $ 116,000 .
−Removed: the six months ended June 30, 2022, 50,000 RSUs granted in May 2019 vested, and in May 2022, the Company issued 36,851 shares of common
−Removed: stock, net of 13,149 shares of common stock withheld for payroll tax withholdings totaling $ 99,000 .
−Removed: the six months ended June 30, 2022, 19,288 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.
+Added: the nine months ended September 30, 2022, 35,000 RSUs granted in February 2019 vested, and in February 2022, the Company issued 20,298
+Added: shares of common stock, net of 14,702 shares of common stock withheld for payroll tax withholdings totaling $ 116,000 .
+Added: the nine months ended September 30, 2022, 50,000 RSUs granted in May 2019 vested, and in May 2022, the Company issued 36,851 shares of
+Added: common stock, net of 13,149 shares of common stock withheld for payroll tax withholdings totaling $ 99,000 .
+Added: the nine months ended September 30, 2022, 35,693 shares of the Company’s common stock underlying RSUs issued to directors vested,
+Added: but the issuance 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
7 unchanged sentences
with the 2007 Plan, the “Plans”).
−Removed: As of June 30, 2022, the 2017 Plan provides for the issuance of a maximum of 6,000,000
+Added: As of September 30, 2022, the 2017 Plan provides for the issuance of a maximum of 6,000,000
shares of the Company’s common stock.
6 unchanged sentences
The Plans are administered by the Compensation Committee of the Company’s Board of Directors.
−Removed: The Company had 2,067,284 shares available for future issuances under the 2017 Plan at June 30, 2022.
−Removed: summary of stock option activity under the Plans for the six months ended June 30, 2022 is as follows:
−Removed: OF STOCK OPTION PLAN ACTIVITY
+Added: The Company had 2,058,280 shares available for future issuances under the 2017 Plan at September 30, 2022.
+Added: summary of stock option activity under the Plans for the nine months ended September 30, 2022 is as follows:
+Added: SCHEDULE OF STOCK OPTION PLAN ACTIVITY
+Added: Exercise Price
+Added: Contractual Life
+Added: Intrinsic Value
Options outstanding – January 1, 2022
2 unchanged sentences
Options cancelled/forfeited
−Removed: Options outstanding – June 30, 2022
+Added: Options outstanding – September 30, 2022
Options exercisable
2 unchanged sentences
have been received by option holders if all option holders had exercised and immediately sold all shares underlying options with an exercise
−Removed: price lower than the market price on June 30, 2022, based on the closing price of the Company’s common stock of $ 7.28 on that date.
−Removed: the six months ended June 30, 2022, the Company granted stock options to certain employees.
−Removed: The stock options were granted with an exercise
−Removed: price equal to the current market price of the Company’s common stock, as reported by the securities exchange on which the common
−Removed: stock was then listed, at the grant date and have contractual terms of ten years .
−Removed: Vesting terms for options granted to employees during
−Removed: the three and six months ended June 30, 2022 included the following vesting schedule:
−Removed: 25% of the shares subject to the option vest and
−Removed: become exercisable on the first anniversary of the grant date and the remaining 75% of the shares subject to the option vest and become
−Removed: exercisable quarterly in equal installments thereafter over three years.
−Removed: Certain option awards provide for accelerated vesting if there
−Removed: is a change in control (as defined in the Plans) and in the event of certain modifications to the option award agreement .
+Added: price lower than the market price on September 30, 2022, based on the closing price of the Company’s common stock of $ 12.07 on
+Added: the nine months ended September 30, 2022, the Company granted stock options to certain employees.
+Added: The stock options were granted with
+Added: an exercise price equal to the current market price of the Company’s common stock, as reported by the securities exchange on which
+Added: the common stock was then listed, at the grant date and have contractual terms of ten years .
+Added: Vesting terms for options granted to employees
+Added: during the three and nine months ended September 30, 2022 included the following vesting schedule:
+Added: 25% of the shares subject to the option
+Added: vest and become exercisable on the first anniversary of the grant date and the remaining 75% of the shares subject to the option vest
+Added: and become exercisable quarterly in equal installments thereafter over three years .
+Added: Certain option awards provide for accelerated vesting
+Added: if there is a change in control (as defined in the Plans) and in the event of certain modifications to the option award agreement.
fair value of each option award is estimated on the date of grant using the Black-Scholes-Merton option pricing model.
13 unchanged sentences
used for valuing options granted to employees:
−Removed: OF FAIR VALUE ASSUMPTIONS
+Added: SCHEDULE OF FAIR VALUE ASSUMPTIONS
Weighted-average fair value of options granted
4 unchanged sentences
Dividend yield
−Removed: following table summarizes information about stock options outstanding and exercisable at June 30, 2022:
−Removed: OF STOCK OPTION OUTSTANDING AND EXERCISABLE
−Removed: of Exercise Prices
−Removed: $ 1.47 - $ 2.23
+Added: following table summarizes information about stock options outstanding and exercisable at September 30, 2022:
+Added: SCHEDULE OF STOCK OPTION OUTSTANDING AND EXERCISABLE
$ 2.40 - $ 3.50
3 unchanged sentences
$ 7.89 - $ 8.75
−Removed: of June 30, 2022, there was approximately $ 2,013,000 of total unrecognized compensation expense related to unvested stock options granted
−Removed: under the Plans.
+Added: of September 30, 2022, there was approximately $ 1,830,000 of total unrecognized compensation expense related to unvested stock options
+Added: granted under the Plans.
That expense is expected to be recognized over the weighted-average remaining vesting period of 4.34 years.
−Removed: The stock-based
−Removed: compensation for all stock options was $ 258,000 and $ 530,000 during the three and six months ended June 30, 2022, respectively, and $ 569,000
−Removed: and $ 1,021,000 during the same periods in 2021, respectively.
−Removed: intrinsic value of options exercised during the six months ended June 30, 2022 was $ 754,000 .
+Added: The stock-based compensation for all stock options was $ 241,000 and $ 771,000 during the three and nine months ended September 30, 2022,
+Added: respectively, and $ 355,000 and $ 1,376,000 during the same periods in 2021, respectively.
+Added: intrinsic value of options exercised during the nine months ended September 30, 2022 was $ 794,000 .
Stock Units/Performance Stock Units
2 unchanged sentences
grant date, is expensed over the vesting period of the RSUs.
−Removed: summary of the Company’s RSU activity (including performance stock units) and related information for the six months ended June
+Added: summary of the Company’s RSU activity (including performance stock units) and related information for the nine months ended September
30, 2022 is as follows:
OF RESTRICTED STOCK UNITS ACTIVITY
+Added: Average Grant
+Added: Date Fair Value
RSUs unvested – January 1, 2022
RSUs cancelled/forfeited
−Removed: RSUs unvested - June 30, 2022
−Removed: of June 30, 2022, the total unrecognized compensation expense related to unvested RSUs was approximately $ 8,819,000 , which is expected
+Added: RSUs unvested – September 30, 2022
+Added: of September 30, 2022, the total unrecognized compensation expense related to unvested RSUs was approximately $ 5,755,000 , which is expected
to be recognized over a weighted-average period of 0.85 years, based on estimated and actual vesting schedules of the applicable RSUs.
−Removed: The stock-based compensation for RSUs during the three and six months ended June 30, 2022 was $ 1,735,000 and $ 3,479,000 , respectively,
+Added: The stock-based compensation for RSUs during the three and nine months ended September 30, 2022 was $ 1,691,000 and $ 5,170,000 , respectively,
and $ 1,340,000 and $ 2,167,000 during the same periods in 2021, respectively.
1 unchanged sentence
and other non-employees for services rendered or to be rendered in the future, or pursuant to settlement agreements.
−Removed: summary of warrant activity for the six months ended June 30, 2022 is as follows:
+Added: summary of warrant activity for the nine months ended September 30, 2022 is as follows:
OF WARRANTS ACTIVITY
+Added: Subject to Warrants
+Added: Exercise Price
Warrants outstanding – January 1, 2022
−Removed: Warrants outstanding and exercisable – June
+Added: Warrants outstanding and exercisable – September
Weighted average remaining contractual life of
−Removed: the outstanding warrants in years – June 30, 2022
−Removed: outstanding and exercisable as of June 30, 2022 are as follows:
+Added: the outstanding warrants in years – September 30, 2022
+Added: outstanding and exercisable as of September 30, 2022 are as follows:
OF WARRANTS OUTSTANDING AND WARRANTS EXERCISABLE
2 unchanged sentences
Stock-Based Transactions
−Removed: Company recognized $ 0 in stock-based compensation expense related to subsidiary stock options during the three and six months ended June
−Removed: 30, 2022, and $ 28,000 and $ 85,000 during the same periods in 2021, respectively.
+Added: Company recognized $ 0 in stock-based compensation expense related to subsidiary stock options during the three and nine months ended
+Added: September 30, 2022, and $ 2,000 and $ 87,000 during the same periods in 2021, respectively.
Compensation Summary
1 unchanged sentence
OF STOCK BASED COMPENSATION GRANTED TO EMPLOYEES DIRECTORS CONSULTANTS
+Added: Three Months Ended
+Added: September 30,
+Added: Nine Months Ended
+Added: September 30,
Employees – selling, general and administrative
40 unchanged sentences
of the Company’s restricted common stock.
−Removed: Payments totaling $ 92,000 and $ 122,000 were made during the three and six months ended
−Removed: June 30, 2022, respectively, compared to $ 35,000 and $ 70,000 during the same periods in 2021, respectively.
+Added: Payments totaling $ 77,000 and $ 199,000 were made during the three and nine months ended
+Added: September 30, 2022, respectively, compared to $ 44,000 and $ 114,000 during the same periods in 2021, respectively.
Royalty expenses were
−Removed: and $ 177,000 during the three and six months ended June 30, 2022, respectively, compared to $ 44,000 and $ 79,000 during the same periods
−Removed: in 2021, respectively, and was included in accounts payable to Dr.
+Added: $ 67,000 and $ 244,000 during the three and nine months ended September 30, 2022, respectively, compared to $ 51,000 and $ 130,000 during
+Added: the same periods in 2021, respectively, and were included in accounts payable to Dr.
Asset Purchase Agreement – Related Party
10 unchanged sentences
Lindstrom including an initial payment of $ 33,000 upon execution of the Lindstrom APA.
−Removed: was paid $ 7,000 and $ 15,000 in cash during the three and six months ended June 30, 2022, respectively, and $ 7,000 and $ 14,000 during
+Added: was paid $ 8,000 and $ 23,000 in cash during the three and nine months ended September 30, 2022, respectively, and $ 7,000 and $ 21,000 during
the same periods in 2021, respectively.
The Company incurred $ 9,000 and $ 24,000 for royalty expenses related to the Lindstrom APA during
−Removed: the three and six months ended June 30, 2022, respectively, and $ 7,000 and $ 14,000 during the same periods in 2021, respectively.
−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: Dexycu Agreement expires on August 1, 2025 , subject to early termination in accordance with
−Removed: the terms set forth therein.
−Removed: Either party may terminate the Dexycu Agreement, subject to specified
−Removed: notice periods and limitations, in the event of (i) uncured material breach by the other party or (ii) if DEXYCU ceases to have
−Removed: “pass-through” payment status.
−Removed: In addition, subject to certain limitations, the Company may terminate the Dexycu
−Removed: Agreement (i) for convenience subject to an extended specified notice period or (ii) in the event Eyepoint undergoes a change
−Removed: Eyepoint may terminate the Dexycu Agreement , subject to specified notice periods
−Removed: and specified limitations, if the Company fails to achieve certain minimum sales levels during specified periods.
−Removed: During the three and
−Removed: six months ended June 30, 2022, the Company recorded $ 1,212,000 and $ 2,532,000 , respectively, and $ 827,000 and $ 1,312,000 during the
−Removed: same periods in 2021, respectively, in commission revenues related to the Dexycu Agreement.
−Removed: and Marketing Agreements
−Removed: Company has entered various sales and marketing agreements with certain organizations to provide exclusive and non-exclusive sales and
−Removed: marketing representation services to Harrow in select geographies in the U.S.
−Removed: in connection with the Company’s ophthalmic pharmaceutical
−Removed: compounded formulations or related products.
−Removed: the terms of the sales and marketing agreements, the Company is generally required to make commission payments equal to 10 % to 14 % of
−Removed: net sales for products above and beyond the initial existing sales amounts .
−Removed: In addition, the Company is required to make periodic milestone
−Removed: payments to certain organizations in shares of the Company’s restricted common stock if net sales in the assigned territory reach
−Removed: certain future levels by the end of their terms.
−Removed: Commission expenses of $ 1,100,000 and $ 2,147,000 were incurred under these agreements
−Removed: for commission expenses during the three and six months ended June 30, 2022, respectively, and $ 1,032,000 and $ 1,836,000 during the same
−Removed: periods in 2021, respectively.
+Added: the three and nine months ended September 30, 2022, respectively, and $ 7,000 and $ 21,000 during the same periods in 2021, respectively.
+Added: Asset Purchase Agreement – Related Party
+Added: December 2019, the Company entered into an asset purchase agreement (the “Presbyopia APA”) with Richard L.
+Added: Lindstrom, M.D.,
+Added: a member of its Board of Directors.
+Added: Pursuant to the terms of the Presbyopia APA, the Company acquired certain intellectual property and
+Added: related rights from Dr.
+Added: Lindstrom to develop, formulate, make, sell, and sub-license an ophthalmic topical product to treat presbyopia
+Added: (the “Presbyopia Product”).
+Added: the terms of the Presbyopia APA, the Company is required to make royalty payments to Dr.
+Added: Lindstrom ranging from 2% to 4% of net sales,
+Added: dependent upon the final formulation and patent protection of the Presbyopia Product sold .
+Added: Lindstrom was paid $ 0 in cash during the
+Added: three and nine month periods ended September 30, 2022 and 2021, and was due $ 0 at September 30, 2022 and 2021.
+Added: The Company incurred $ 0
+Added: for royalty expenses related to the Presbyopia APA during the three and nine month periods ended September 30, 2022 and 2021.
Purchase, License and Related Agreements
25 unchanged sentences
the Inventors.
−Removed: During the three and six months ended June 30, 2022, $ 297,000 and $ 510,000 were incurred under these agreements as royalty
−Removed: expenses, respectively, and $ 261,000 and $ 493,000 during the same periods in 2021, respectively.
+Added: During the three and nine months ended September 30, 2022, $ 185,000 and $ 695,000 were incurred under these agreements
+Added: as royalty expenses, respectively, and $ 285,000 and $ 778,000 during the same periods in 2021, respectively.
July 2021, the Company entered into a License and Supply Agreement (the “Sintetica Agreement”) with Sintetica S.A.
1 unchanged sentence
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 $ 18,000,000 in one-time milestone payments including a $ 5,000,000 payment
−Removed: (the “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 $ 3,117,000 was paid and recorded as
−Removed: R&D expenses during the year ended December 31, 2021.
−Removed: During the three and six months ended June 30, 2022, no amounts were paid or
−Removed: accrued under the Sintetica agreement.
+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
+Added: royalty for units sold.
+Added: The Company is required to pay Sintetica up to $ 18,000,000
+Added: in one-time milestone payments including a $ 5,000,000
+Added: payment (the “Upfront Payment”) due within 30 days of signing the Sintetica Agreement and the balance of payments due
+Added: upon achievement of certain regulatory and commercial milestones.
+Added: Under the terms of the Sintetica Agreement, Sintetica is
+Added: responsible for regulatory filings for IHEEZO in the U.S.
+Added: The Upfront Payment along with an additional milestone payment of $ 3,117,000
+Added: was paid and recorded as R&D expenses during the year ended December 31, 2021.
+Added: During the three and nine months ended September
+Added: 30, 2022, $ 5,000,000
+Added: was accrued under the Sintetica Agreement related to the FDA approval of the United States NDA for IHEEZO.
to certain limitations, the Sintetica Agreement has a ten-year term, and allows for a ten-year extension if certain sales thresholds
3 unchanged sentences
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 $ 2,000,000 upon the achievement of certain regulatory milestones and up to $ 6,200,000 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 June 30, 2022, no amounts have been paid or accrued under the Wakamoto agreements.
−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: Asset Purchase Agreement – Related Party
−Removed: December 2019, the Company entered into an asset purchase agreement (the “Presbyopia APA”) with Richard L.
−Removed: Lindstrom, M.D.,
−Removed: a member of its Board of Directors.
−Removed: Pursuant to the terms of the Presbyopia APA, the Company acquired certain intellectual property and
−Removed: related rights from Dr.
−Removed: Lindstrom to develop, formulate, make, sell, and sub-license an ophthalmic topical product to treat presbyopia
−Removed: (the “Presbyopia Product”).
−Removed: the terms of the Presbyopia Product, the Company is required to make royalty payments to Dr.
−Removed: Lindstrom ranging from 2% to 4% of net sales,
−Removed: dependent upon the final formulation and patent protection of the Presbyopia Product sold .
−Removed: Lindstrom was paid $ 0 in cash during the
−Removed: three and six month periods ended June 30, 2022 and 2021, and was due $ 0 at June 30, 2022 and 2021.
−Removed: The Company incurred $ 0 for royalty
−Removed: expenses related to the Presbyopia APA during the three and six month periods ended June 30, 2022 and 2021.
+Added: to the Wakamoto Agreements, Wakamoto agreed to supply MAQ-100 to the Company, and the
+Added: Company agreed to pay Wakamoto a per unit transfer price to supply MAQ-100.
+Added: In addition, the Company is required to pay Wakamoto
+Added: various one-time milestone payments totaling up to $ 2,000,000
+Added: upon the achievement of certain regulatory milestones and up to $ 6,200,000
+Added: upon the achievement of certain commercial milestones.
+Added: Under the terms of the Wakamoto Agreements, the Company is responsible
+Added: for regulatory filings and fees for MAQ-100 in the U.S.
+Added: Through September 30, 2022, no amounts have been paid or accrued
+Added: under the Wakamoto Agreements.
+Added: to certain limitations, the term of the Wakamoto Agreements is five years from the date of the FDA’s market approval of
+Added: MAQ-100 with a five-year extension if certain unit sales thresholds are met.
+Added: Commercial Alliance Agreement
+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: will terminate on January 1, 2023 (see Note 17 for more information).
+Added: During the three and nine months ended September 30, 2022, the
+Added: Company recorded $ 1,044,000
+Added: and $ 3,576,000 ,
+Added: respectively, and $ 900,000
+Added: and $ 2,212,000
+Added: during the same periods in 2021, respectively, in commission revenues related to the Dexycu Agreement.
+Added: and Marketing Agreements
+Added: Company has entered various sales and marketing agreements with certain organizations to provide exclusive and non-exclusive sales and
+Added: marketing representation services to Harrow in select geographies in the U.S.
+Added: in connection with the Company’s ophthalmic pharmaceutical
+Added: compounded formulations or related products.
+Added: the terms of the sales and marketing agreements, the Company is generally required to make commission payments equal to 10 % to 14 % of
+Added: net sales for products above and beyond the initial existing sales amounts .
+Added: In addition, the Company is required to make periodic milestone
+Added: payments to certain organizations in shares of the Company’s restricted common stock if net sales in the assigned territory reach
+Added: certain future levels by the end of their terms.
+Added: Commission expenses of $ 1,041,000 and $ 3,188,000 were incurred under these agreements
+Added: for commission expenses during the three and nine months ended September 30, 2022, respectively, and $ 953,000 and $ 2,766,000 during the
+Added: same periods in 2021, respectively.
CONCENTRATIONS
−Removed: Company has two products that each comprised more than 10% of total revenues during the three and six month periods ended June 30.
−Removed: products collectively accounted for 32 % and 32 % of revenues during the three and six months ended June 30, 2022, respectively, and 36 %
−Removed: and 36 % during the same periods in 2021, respectively.
+Added: Company has two products that each comprised more than 10% of total revenues during the three and nine month periods ended September
+Added: 30 2022 and 2021, respectively.
+Added: These products collectively accounted for 34 %
+Added: of revenues during the three and nine months ended September 30, 2022, respectively, and 35 %
+Added: during the same periods in 2021, respectively.
Company sells its compounded formulations to a large number of customers.
There were no customers who comprised more than 10% of the
−Removed: Company’s total pharmacy sales during the three and six months ended June 30, 2022 and 2021.
+Added: Company’s total pharmacy sales during the three and nine months ended September 30, 2022 and 2021.
Company receives its active pharmaceutical ingredients from three main suppliers.
These suppliers collectively accounted for 52 % and
−Removed: 73 % of active pharmaceutical ingredient purchases during the three and six months ended June 30, 2022, respectively, and 85 % and 79 %
+Added: 66 % of active pharmaceutical ingredient purchases during the three and nine months ended September 30, 2022, respectively, and 59 % and
71 % during the same periods in 2021, respectively.
SUBSEQUENT EVENTS
−Removed: Company has performed an evaluation of events occurring subsequent to June 30, 2022 through the filing date of this Quarterly Report.
+Added: Company has performed an evaluation of events occurring subsequent to September 30, 2022 through the filing date of this Quarterly Report.
Based on its evaluation, no events other than those described below need to be disclosed.
−Removed: July 2022, the Center for Medicare & Medicaid Services (“CMS”) published in the Federal Register the calendar year (CY)
−Removed: 2023 Medicare Hospital Outpatient Prospective Payment System (“OPPS”) and ASC Payment System Proposed Rule (“Proposed
−Removed: If the Proposed Rule is finalized, in the relevant part, without changes, it would result in loss of pass-through related
−Removed: separate payment for Dexycu, when furnished in hospital outpatient department settings reimbursed by Medicare.
−Removed: This would reduce the
−Removed: amount of Medicare reimbursement provided to the Dexycu customers and, if finalized without changes, result in a significant reduction
−Removed: in the Company’s Dexycu commission revenues.
−Removed: A Final Rule is expected to be issued in early November 2022.
−Removed: In the Final Rule, CMS
−Removed: may adopt or modify the Proposed Rule’s proposals related to Dexycu.
−Removed: If the Proposed Rule’s proposals related to Dexycu are
−Removed: finalized, they would be effective on January 1, 2023.
−Removed: If adopted as currently proposed, the Company does not expect the Proposed Rule
−Removed: to have a material impact on its operations, financial statements and cash flows.
+Added: October 2022, t he Company issued 306,347 shares of its common stock upon the cashless exercise
+Added: of warrants to purchase 373,847 shares of common stock, with an exercise price $ 2.08 per share.
+Added: October 2022, the Company issued 31,000 shares of common stock upon the exercise of options to purchase 31,000 shares of common stock
+Added: at exercise prices of $ 1.70 - $ 8.40 per share.
+Added: the preliminary Hospital Outpatient Prospective Payment System (HOPPS) rule proposed by the Centers for Medicare & Medicaid
+Added: Services (CMS) in July of 2022, which did not contain an extension of the pass-through payment period for Dexycu beyond December 31,
+Added: 2022, the Company entered into a Mutual Termination Agreement (the “Termination Agreement”) with Eyepoint on October 7,
+Added: 2022, pursuant to which Eyepoint and the Company agreed (a) that the Company will continue to support the sale of Dexycu through the
+Added: fourth quarter of 2022, consistent with the Company’s level of effort during the January through June 2022 period, (b) to
+Added: decrease the required minimum quarterly sales levels based on Dexycu unit demand for the fourth quarter of 2022, and (c) to
+Added: terminate the Dexycu Agreement, along with ancillary letter agreements, effective January 1, 2023.
+Added: of Non-Ophthalmology Revenues
+Added: October 2022, wholly-owned subsidiaries of the Company (“Imprimis”) entered into an Asset Purchase Agreement (the
+Added: “RPC Agreement”) with Innovation Compounding Pharmacy, LLC (the “Buyer”).
+Added: The closing of the RPC Agreement
+Added: was made effective on September 30, 2022;
+Added: however, control of the assets transferred to the Buyer, and a closing payment was made,
+Added: in October 2022.
+Added: Under the terms of the RPC Agreement, Imprimis agreed to sell substantially all of its assets associated with its
+Added: non-ophthalmology related compounding product line, including but not limited to, certain intellectual property rights, customer
+Added: lists, databases, and formulations (the “RPC Assets”).
+Added: The Buyer agreed to make offers of employment to six of the
+Added: Company’s employees that were responsible for the sales activities associated with the RPC Assets.
+Added: In connection with the RPC
+Added: Agreement, Imprimis entered into a separate transition services agreement with the Buyer related to providing on going services,
+Added: such as procuring and dispensing prescription orders associated with RPC Assets.
+Added: The Company expects Imprimis to provide transition
+Added: services to the Buyer for up to six months following the effective date of the RPC Agreement.
+Added: Under the terms of the RPC Agreement,
+Added: the Buyer paid Imprimis an aggregate cash amount of $ 6,000,000
+Added: in October 2022.
+Added: In addition, the Buyer is obligated to pay up to $ 4,500,000
+Added: to Imprimis based on mutually agreed upon revenue milestones during the calendar year 2023.
+Added: The Company determined that the
+Added: disposal of the related net assets does not qualify for reporting as a discontinued operation because it does not represent a
+Added: strategic shift that has or will have a major effect on the Company’s operations and financial results.
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.