13 unchanged sentences
(the “Company”) as of December 31, 2022 and 2021,
−Removed: the related statements of operations, stockholders’ equity, and cash flows
−Removed: for each of the three years in the period ended December 31, 2021, and the related notes (collectively referred to as the “financial statements”).
+Added: the related statements of operations, stockholders’ equity, and cash flows for each of the three years in the period ended December
+Added: 31, 2022, and the related notes (collectively referred to as the “financial statements”).
In our opinion, the financial statements
5 unchanged sentences
statements based on our audits.
−Removed: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United
−Removed: States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.
federal securities
47 unchanged sentences
evaluated trends in actual sales and discount accrual balances, and compared cash receipts to product sales.
−Removed: We also examined
−Removed: terms and conditions for a sample of contracts with the Company’s customers, tested a sample of credits issued and payments
−Removed: made throughout the year and agreed rates to underlying contract terms.
+Added: We also examined terms and
+Added: conditions for a sample of contracts with the Company’s customers, tested a sample of credits issued and payments made throughout
+Added: the year and agreed rates to underlying contract terms.
KMJ Corbin & Company LLP
2 unchanged sentences
thousands, except share and per share amounts)
−Removed: and cash equivalents
−Removed: receivable, net
−Removed: expenses and other current assets
Current assets:
−Removed: and equipment, net
−Removed: lease right-of-use assets, net
−Removed: long-term assets, net
−Removed: and stockholders’ equity
−Removed: loan, current portion
−Removed: portion of long-term debt
+Added: Cash and cash equivalents
+Added: Accounts receivable, net
+Added: Prepaid expenses and other current assets
+Added: Total current assets
+Added: Property and equipment, net
+Added: Intangible assets, net
+Added: Operating lease right-of-use assets, net
+Added: Other long-term assets, net
+Added: Liabilities and stockholders’ equity
Current liabilities:
−Removed: debt, net of discount and including accrued fees
−Removed: portion of PPP and EIDL loans
−Removed: lease liabilities, net of current portion
−Removed: and contingencies (Note 14)
−Removed: Stockholders’
−Removed: stock, $ 0.001 par value;
−Removed: 50,000,000 shares authorized;
−Removed: 24,626,004 and 24,312,808 shares issued and outstanding at December 31, 2021
−Removed: and 2020, respectively
−Removed: paid-in capital
+Added: Accounts payable
+Added: Current portion of long-term debt
+Added: Accrued liabilities
+Added: Total current liabilities
+Added: Long-term debt, net of discount and including accrued fees
+Added: Operating lease liabilities, net of current portion
+Added: Total liabilities
+Added: Commitments and contingencies (Note 14)
Stockholders’ equity
−Removed: liabilities and stockholders’ equity
+Added: Common stock, $ 0.001 par value;
+Added: 50,000,000 shares authorized;
+Added: 25,353,119 and 24,626,004 shares issued and outstanding at December 31, 2022 and 2021, respectively
+Added: Additional paid-in capital
+Added: Accumulated deficit
+Added: Total stockholders’ equity
+Added: Total liabilities and stockholders’ equity
accompanying notes are an integral part of these financial statements.
2 unchanged sentences
thousands, except per share amounts)
−Removed: the years ended
−Removed: sales and royalties, net
−Removed: sales and royalties
+Added: For the years ended
+Added: Licensing revenue
+Added: Product sales and royalties, net
+Added: Total net revenues
Cost of Sales:
−Removed: profit (loss)
−Removed: and development
−Removed: and administrative
+Added: Licensing revenue
+Added: Product sales and royalties
+Added: Total cost of sales
+Added: Gross profit (loss)
Operating expenses:
−Removed: from operations
−Removed: income (expense):
−Removed: and other income (expense), net
−Removed: on PPP loan forgiveness
−Removed: on equipment sale
−Removed: before income tax expense
−Removed: loss per share, basic and diluted
−Removed: average number of common shares outstanding, basic and diluted
+Added: Research and development
+Added: General and administrative
+Added: Total operating expenses
+Added: Loss from operations
+Added: Other income (expense):
+Added: Interest and other income (expense), net
+Added: Gain on PPP loan forgiveness
+Added: Gain on equipment sale
+Added: Loss before income tax expense
+Added: Income tax expense
+Added: Net loss per share, basic and diluted
+Added: Weighted average number of common shares outstanding, basic and diluted
accompanying notes are an integral part of these financial statements.
2 unchanged sentences
thousands, except share amounts)
−Removed: Stockholders’
−Removed: at December 31, 2018
−Removed: option exercises
−Removed: from sales of common stock, net of offering costs
+Added: Additional Paid-in
+Added: Total Stockholders’
+Added: Balances at December 31, 2019
+Added: Stock-based compensation
+Added: Stock option exercises
+Added: Employee stock purchase plan
Proceeds from sales of common stock, net of offering costs
−Removed: of common stock for product candidate licensing rights
−Removed: Issuance of common stock for product candidate licensing
−Removed: rights, shares
−Removed: stock issued related to restricted stock units
−Removed: Common stock issued related to restricted stock units, shares
−Removed: stock issued under employee stock purchase plan
−Removed: warrant exercises
−Removed: fair value of warrants to purchase common stock issued in connection with debt
−Removed: at December 31, 2019
−Removed: option exercises
−Removed: stock purchase plan
−Removed: from sales of common stock, net of offering costs
−Removed: of common stock for product candidate licensing rights
−Removed: fair value of warrants to purchase common stock issued in connection with debt
−Removed: at December 31, 2020
−Removed: option exercises
−Removed: stock purchase plan
−Removed: stock issued related to restricted stock units
−Removed: warrant exercises
−Removed: at December 31, 2021
+Added: Issuance of common stock for product candidate licensing rights
+Added: Relative fair value of warrants to purchase common stock issued in connection with debt
+Added: Balances at December 31, 2020
+Added: Stock-based compensation
+Added: Stock option exercises
+Added: Employee stock purchase plan
+Added: Common stock issued related to restricted stock units
+Added: Stock warrant exercises
+Added: Balances at December 31, 2021
+Added: Beginning balance, value
+Added: Stock-based compensation
+Added: Stock option exercises
+Added: Employee stock purchase plan
+Added: Stock warrant exercises
+Added: Balances at December 31, 2022
+Added: $ ( 103,134 )
+Added: Ending balance, value
+Added: $ ( 103,134 )
accompanying notes are an integral part of these financial statements.
1 unchanged sentence
OF CASH FLOWS
−Removed: the years ended
−Removed: flows from operating activities
−Removed: to reconcile net loss to net cash used in operating activities:
−Removed: stock issued for product candidate licensing rights
−Removed: and amortization
−Removed: discount amortization
−Removed: on forgiveness of PPP loan
−Removed: on sale of equipment
−Removed: in operating assets and liabilities:
−Removed: expenses and other assets
−Removed: cash used in operating activities
−Removed: used in investing activities
−Removed: from sale of equipment
−Removed: of property and equipment
−Removed: of product licensing rights
+Added: For the years ended
+Added: Cash flows from operating activities
+Added: Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
+Added: Stock-based compensation
+Added: Common stock issued for product candidate licensing rights
+Added: Depreciation and amortization
+Added: Debt discount amortization
+Added: Gain on forgiveness of PPP loan
+Added: Gain on sale of equipment
+Added: Changes in operating assets and liabilities:
+Added: Accounts receivable
+Added: Prepaid expenses and other assets
+Added: Accounts payable
+Added: Accrued liabilities
+Added: Net cash provided by (used in) operating activities
Cash used in investing activities
−Removed: flows from financing activities
−Removed: from issuance of long-term debt, net of issuance costs
−Removed: from sales of common stock, net of offering costs
−Removed: from PPP and EIDL loans
−Removed: from employee stock purchase plan and stock option exercises
−Removed: cash provided by financing activities
−Removed: in cash and cash equivalents
−Removed: and cash equivalents at beginning of year
−Removed: and cash equivalents at end of year
−Removed: disclosures of cash flow information
−Removed: paid for interest
−Removed: paid for income taxes
−Removed: disclosures of non-cash investing and financing activities:
−Removed: fair value of common stock warrants issued in connection with debt
−Removed: assets obtained in exchange for lease liabilities
+Added: Proceeds from sale of equipment
+Added: Purchases of property and equipment
+Added: Purchase of product licensing rights
+Added: Net cash used in investing activities
+Added: Cash flows from financing activities
+Added: Proceeds from issuance of long-term debt, net of issuance costs
+Added: Proceeds from sales of common stock, net of offering costs
+Added: Proceeds from PPP and EIDL loans
+Added: Proceeds from employee stock purchase plan and stock option
+Added: and stock warrant exercises
+Added: Net cash (used in) provided by financing activities
+Added: Change in cash and cash equivalents
+Added: Cash and cash equivalents at beginning of year
+Added: Cash and cash equivalents at end of year
+Added: Supplemental disclosures of cash flow information
+Added: Cash paid for interest
+Added: Cash paid for income taxes
+Added: Supplemental disclosures of non-cash investing and financing activities:
+Added: Relative fair value of common stock warrants issued in connection with debt
+Added: Right-of-use assets obtained in exchange for lease liabilities
accompanying notes are an integral part of these financial statements.
3 unchanged sentences
1 — Company Overview
−Removed: Pharmaceuticals, Inc.
−Removed: (“Eton” or the “Company”) was incorporated as a Delaware “C” corporation on
−Removed: April 27, 2017 and was initially set up as a wholly-owned subsidiary of Harrow Health, Inc.
−Removed: (“Harrow”, fka Imprimis Pharmaceuticals,
−Removed: In June 2017, the Company raised $ 20,055 in start-up capital through a private sale of preferred stock and a separate management
−Removed: team was then established for Eton with its corporate offices located in Deer Park, Illinois.
−Removed: In November 2018, the Company completed
−Removed: an initial public offering (the “IPO”) and received net proceeds of $ 21,960 , after deducting underwriting discounts and commissions
−Removed: and offering-related expenses.
−Removed: In November 2019, the Company entered into a credit agreement and received net proceeds of $ 4,750 and
−Removed: in August 2020 the Company received net proceeds of $ 1,965 under the credit agreement (see Note 5).
−Removed: In March and April 2020, Eton received
−Removed: net proceeds of $ 7,756 from the sale of shares of its common stock and in October 2020, the Company received net proceeds of $ 21,026
−Removed: from a public offering for its shares at an offering price of $ 7.00 per share (see Note 6).
−Removed: is a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative products.
−Removed: Eton is primarily focused
−Removed: on hospital injectable and rare disease products.
−Removed: The Company seeks to improve the formula, delivery system, or safety of existing molecules
−Removed: in order to address unmet patient needs.
−Removed: Eton pursues what it perceives to be low-risk product candidates where existing published literature,
−Removed: historical clinical trials, or physician usage has established safety and/or efficacy of the molecule, thereby reducing the incremental
−Removed: clinical burden required for the Company to bring the product to patients.
−Removed: Company’s Biorphen® product was approved by the FDA in October 2019 and sales commenced for this product at the end of 2019.
−Removed: Eton’s EM-100 product was sold to Bausch Health and the product was approved by the FDA in September 2020.
−Removed: Bausch Health launched
−Removed: this product under the name of Alaway® Preservative Free in January 2021 and Eton receives royalties from the sale of the product.
−Removed: The Company acquired the licensing rights to Alkindi Sprinkle and this product was approved by the FDA in October 2020 and launched in
−Removed: December 2020.
−Removed: The Company entered into a co-promotion agreement with Tolmar Pharmaceuticals in November 2021 whereby Tolmar will promote
−Removed: Alkindi Sprinkle through its 60+ person salesforce in exchange for a royalty on net sales.
−Removed: In addition, the Company launched Carglumic
−Removed: Acid tablets in December 2021 as the first and only FDA-approved generic version of Carbaglu®.
+Added: is an innovative pharmaceutical company focused on developing, acquiring, and commercializing innovative products to address unmet needs
+Added: in patients suffering from rare diseases.
+Added: Company currently has three FDA-approved rare disease products, ALKINDI SPRINKLE® for the treatment of adrenocortical insufficiency,
+Added: Carglumic Acid for the treatment of hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency, and Betaine Anhydrous for the
+Added: treatment of homocystinuria and has three additional product candidates in late-stage development.
+Added: The Company is developing dehydrated
+Added: alcohol injection, which has received Orphan Drug Designation for the treatment of methanol poisoning, ZENEO® hydrocortisone autoinjector
+Added: for the treatment of adrenal crisis, and ET-400.
+Added: addition, the Company is entitled to royalties or milestone payments from six FDA-approved products that the Company developed and
+Added: out-licensed.
+Added: The products are Alaway® Preservative Free, EPRONTIA®, Cysteine Hydrochloride, ZONISADE™, Lamotrigine,
+Added: and Biorphen®.
2 — Liquidity Considerations
−Removed: of December 31, 2021, the Company had an accumulated deficit of $ 94,113
−Removed: and for the year ended December 31, 2021 the Company used net cash in operating activities of $ 4,721 .
−Removed: date, the Company has generated revenues from six products and expects further growth in 2022 and beyond in accordance with additional
−Removed: market penetration from these products plus revenues from licensing and additional products where it anticipates FDA approval.
−Removed: currently believes its existing cash and cash equivalents of $ 14,406
−Removed: as of December 31, 2021 augmented by the $ 5,000
−Removed: milestone payment received in January 2022 for
−Removed: the commercial launch of EPRONTIA™ (Topiramate oral solution) by Azurity Pharmaceuticals (“Azurity”),
−Removed: will be sufficient to fund its operating expenses and capital expenditure requirements for at least the next twelve months from the date
−Removed: of issuance of these financial statements.
−Removed: This estimate is based on the Company’s current assumptions, including assumptions relating
−Removed: to estimated sales and its ability to manage its spending.
−Removed: The Company could use its available capital resources sooner than currently
−Removed: Accordingly, the Company could seek to obtain additional capital through equity financings, the issuance of debt or other arrangements.
−Removed: However, there can be no assurance that the Company will be able to raise additional capital if needed or under acceptable terms, if
−Removed: The sale of additional equity may dilute existing stockholders and newly issued shares may contain senior rights and preferences
−Removed: compared to currently outstanding common shares.
−Removed: The Company’s existing long-term debt obligation contains covenants and limits
−Removed: the Company’s ability to pay dividends or make other distributions to stockholders.
−Removed: If the Company experiences delays in product
−Removed: sales growth and completing its product development and obtaining regulatory approval for its other product candidates and is unable
−Removed: to obtain such additional financing, operations would need to be scaled back or discontinued.
+Added: of December 31, 2022, the Company had an accumulated deficit of $ 103,134 and for the year ended December 31, 2022 the Company had a net loss of $ 9,021 .
+Added: date, the Company has generated revenues from multiple products and expects further growth in 2023 and beyond in accordance with additional
+Added: market penetration from these products plus revenues from additional products where it anticipates FDA approval.
+Added: The Company currently
+Added: believes its existing cash and cash equivalents of $ 16,305 as of December 31, 2022 will be sufficient to fund its operating expenses
+Added: and capital expenditure requirements for at least the next twelve months from the date of issuance of these financial statements.
+Added: estimate is based on the Company’s current assumptions, including assumptions relating to estimated sales and its ability to manage
+Added: its spending.
+Added: The Company could use its available capital resources sooner than currently expected.
+Added: Accordingly, the Company could seek
+Added: to obtain additional capital through equity financings, the issuance of debt or other arrangements.
+Added: However, there can be no assurance
+Added: that the Company will be able to raise additional capital if needed or under acceptable terms, if at all.
+Added: The sale of additional equity
+Added: may dilute existing stockholders and newly issued shares may contain senior rights and preferences compared to currently outstanding
+Added: common shares.
+Added: The Company’s existing long-term debt obligation contains covenants and limits the Company’s ability to pay
+Added: dividends or make other distributions to stockholders.
+Added: If the Company experiences delays in product sales growth and completing its product
+Added: development and obtaining regulatory approval for its other product candidates and is unable to obtain such additional financing, operations
+Added: would need to be scaled back or discontinued.
+Added: 3 — Summary of Significant Accounting Policies
+Added: of Presentation
+Added: Company has prepared the accompanying financial statements in accordance with GAAP.
Pharmaceuticals, Inc.
1 unchanged sentence
thousands, except share and per share amounts)
−Removed: 3 — Summary of Significant Accounting Policies
−Removed: of Presentation
−Removed: Company has prepared the accompanying financial statements in accordance with accounting principles generally accepted in the United
−Removed: States of America (“GAAP”).
−Removed: preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported
−Removed: amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the
−Removed: reported amounts of revenue and expenses during the reporting periods.
−Removed: Significant estimates and assumptions reflected in these financial
−Removed: statements include, but are not limited to, provisions for uncollectible receivables, chargebacks and sales returns, valuation
−Removed: of inventories, useful lives of assets and the impairment of property and equipment, the accrual of research and development expenses
−Removed: and the valuation of common stock, stock options and warrants.
−Removed: Estimates are periodically reviewed in light of changes in circumstances,
−Removed: facts and experience.
−Removed: Changes in estimates are recorded in the period in which they become known.
−Removed: Actual results could differ from those
−Removed: estimates or assumptions.
+Added: 3 — Summary of Significant Accounting Policies (continued)
+Added: preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the
+Added: reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial
+Added: statements and the reported amounts of revenue and expenses during the reporting periods.
+Added: Significant estimates and assumptions
+Added: reflected in these financial statements include, but are not limited to, provisions for uncollectible receivables, chargebacks and
+Added: sales returns, valuation of inventories, useful lives of assets and the impairment of property and equipment, deferred tax assets,
+Added: the accrual of research and development expenses and the valuation of common stock, stock options and warrants, and restricted stock
+Added: units (“RSUs”).
+Added: Estimates are periodically reviewed in light of changes in circumstances, facts and experience.
+Added: in estimates are recorded in the period in which they become known.
+Added: Actual results could differ from those estimates or
Company operates the business on the basis of a single reportable segment, which is the business of developing and commercializing prescription
4 unchanged sentences
Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents.
−Removed: cash equivalents are held in U.S.
+Added: and cash equivalents are held in U.S.
financial institutions or invested in short-term U.S.
−Removed: treasury bills.
−Removed: Cash equivalents consist of an
−Removed: interest-bearing checking account and a U.S.
−Removed: treasury bill.
−Removed: From time to time, amounts deposited with its bank exceed federally insured
−Removed: The Company believes the associated credit risk to be minimal.
+Added: treasury bills or high-grade money market funds.
+Added: From time to time,
+Added: amounts deposited with its bank exceed federally insured limits.
+Added: The Company believes the associated credit risk to be
receivable are recorded at the invoiced amount and are non-interest bearing.
4 unchanged sentences
Company values its inventories at the lower of cost or net realizable value using the first-in, first-out method of valuation.
−Removed: reviews its inventories for potential excess or obsolete issues on an ongoing basis and will record a write-down if an impairment is
+Added: Company reviews its inventories for potential excess or obsolete issues on an ongoing basis and will record a write-down if an
+Added: impairment is identified.
Inventories at December 31, 2022 and 2021 consist solely of purchased finished goods.
−Removed: At December 31, 2021, inventories are
−Removed: shown net of a slow-moving reserve for its Biorphen product of $ 1,414 due to the risk of expiry before this entire stock of inventories
−Removed: There was an inventory reserve of $ 1,414 and $ 623 at December 31, 2021 and 2020, respectively.
+Added: At December 31,
+Added: 2022, inventories are shown net of a reserve for damaged Biorphen inventory yet to be destroyed and net of ALKINDI SPRINKLE®
+Added: inventory at risk of expiry prior to being sold.
+Added: At December 31, 2021, inventories are shown net of a reserve for Biorphen inventory
+Added: due to the risk of expiry prior to being sold.
+Added: There was an inventory reserve of $ 62
+Added: at December 31, 2022 and 2021, respectively.
and Equipment
12 unchanged sentences
3 — Summary of Significant Accounting Policies (continued)
−Removed: Company capitalizes payments it makes for licensed products when the payment is based on FDA approval for the product and the cost is
−Removed: recoverable based on expected future cash flows from the product.
−Removed: The cost is amortized on a straight-line basis over the estimated useful
−Removed: life of the product commencing on the approval date in accordance with Accounting Standards Codification (“ASC”) 350 —
−Removed: Intangibles - Goodwill and Other.
−Removed: payment related to the approval of the Company’s
−Removed: Biorphen product in 2019 has been capitalized and that cost
−Removed: is being amortized over five years .
−Removed: payment related to the approval of the Company’s
−Removed: Carglumic Acid product in December 2021 has been capitalized and that cost is being amortized over ten years.
−Removed: The intangible assets,
−Removed: net on the Company’s balance sheet reflected $ 379
+Added: Company capitalizes payments it makes for licensed products when the payment is based on FDA approval for the product and the cost
+Added: is recoverable based on expected future cash flows from the product.
+Added: The cost is amortized on a straight-line basis over the
+Added: estimated useful life of the product commencing on the approval date in accordance with Accounting Standards Codification
+Added: (“ASC”) 350 — Intangibles - Goodwill and Other.
+Added: In November 2021, the Company purchased the rights for its
+Added: Carglumic Acid product for $ 3,250
+Added: and that cost is being amortized over ten
+Added: payment related to the approval of Biorphen had been capitalized in 2019 and that cost was being amortized over five
+Added: As a result of the Biorphen sale to Dr.
+Added: Reddy’s (see Note 14), amortization of that asset was accelerated to record $ 275
+Added: of expense in June 2022 and the remaining $ 75
+Added: of expense in the last six months of the year ended December 31, 2022.
+Added: payment related to the approval of Rezipres® had been capitalized in Q1 2022 and that cost was being amortized over five
+Added: As a result of the sale to Dr.
+Added: Reddy’s, amortization of the Rezipres® asset was accelerated to record the
+Added: remaining $ 738
+Added: in the three-month period ended June 30, 2022.
+Added: In September 2022, the Company purchased the rights for its Betaine Anhydrous product
+Added: and that cost is being amortized over five
+Added: The intangible assets, net on the Company’s balance sheet reflected $ 1,996
of accumulated amortization as of December 31, 2022.
−Removed: 2021 and 2020, respectively.
−Removed: The Company recorded amortization expense of $ 204 ,
−Removed: $ 25 for the years ended December 31, 2021, 2020
−Removed: and 2019, respectively, and will record amortization expense of $ 475
−Removed: per year for these intangible assets for 2022
−Removed: through 2023 and then $ 450
−Removed: in 2024 when the Biorphen asset will be fully
−Removed: For 2025 through 2030, the Company will incur amortization expense of $ 325
−Removed: and then $ 271
−Removed: in 2031 when the Carglumic Acid asset will be
−Removed: fully amortized.
+Added: The Company recorded $ 1,617 ,
+Added: of amortization expense for the years ended December 31, 2022, 2021, and 2020 respectively.
+Added: During the years ended December 31, 2021
+Added: and 2020, the Company reclassified $ 204
+Added: of amortization expense of intangible assets, respectively, to cost of sales to conform with the current year presentation.
+Added: below shows the estimated remaining amortization for these products for each of the five years from 2023 to 2027 and
+Added: Intangible Assets Amortization Expenses
+Added: Amortization Expense
+Added: Total estimated amortization expense
of Long-Lived Assets
21 unchanged sentences
of a contract to determine if it is a lease whereby the terms of the agreement convey the right to control the direct use and receive
−Removed: substantially all of the economic benefits of an identified asset for a period of time in exchange for consideration.
−Removed: The associated
−Removed: right-of-use assets and lease liabilities are recognized at lease commencement.
−Removed: The Company measures lease liabilities based on the present
−Removed: value of the lease payments over the lease term discounted using the rate it would pay on a loan with the equivalent payments and term
−Removed: for the lease.
+Added: substantially all the economic benefits of an identified asset for a period of time in exchange for consideration.
+Added: The associated right-of-use
+Added: assets and lease liabilities are recognized at lease commencement.
+Added: The Company measures lease liabilities based on the present value
+Added: of the lease payments over the lease term discounted using the rate it would pay on a loan with the equivalent payments and term for
The Company does not include the impact for lease term options that would extend or terminate the lease unless it is reasonably
10 unchanged sentences
Company commences recognizing operating lease expense when the lessor makes the underlying asset available for use by the Company and
−Removed: the operating lease expense is recognized on a straight-line basis.
+Added: the operating lease expense is recognized on a straight-line basis over the term of the lease.
Variable lease payments are expensed as incurred.
13 unchanged sentences
by the financial institutions holding its cash and cash equivalents to the extent recorded on the balance sheets.
+Added: The Company believes
+Added: the associated credit risk to be minimal.
Company is dependent on third-party suppliers for its products and product candidates.
7 unchanged sentences
3 — Summary of Significant Accounting Policies (continued)
−Removed: Company is also subject to credit risk from its accounts receivable related to product sales as it extends credit based on an evaluation
−Removed: of the customer’s financial condition, and collateral is not required.
−Removed: Management monitors its exposure to accounts receivable
−Removed: by periodically evaluating the collectability of the account receivable based on a variety of factors including the length of time the
−Removed: receivables are past due, the financial health of the customer and historical experience.
−Removed: Based upon the review of these factors, the
−Removed: Company recorded no allowance for doubtful accounts at December 31, 2021 or 2020.
−Removed: The accounts receivable balance at December 31, 2021
−Removed: and 2020 and product sales revenue recognized during the year ended December 31, 2021 and 2020 consist of sales to and amounts due from
−Removed: AmerisourceBergen Corporation, Cardinal Health Services and McKesson Corporation for sales of the Company’s Biorphen product.
−Removed: December 31, 2021 accounts receivable balance and sales in 2021 also include a $ 5,000
−Removed: milestone from Azurity, in accordance with the
−Removed: Eprontia™ (topiramate oral solution) product, amounts due from AnovoRx for sales of the Company’s Alkindi Sprinkle
−Removed: product and its Carglumic Acid product, which launched in December 2021.
+Added: Company is also subject to credit risk from its accounts receivable related to product sales as it extends credit based on an
+Added: evaluation of the customer’s financial condition, and collateral is not required.
+Added: Management monitors its exposure to accounts
+Added: receivable by periodically evaluating the collectability of the account receivable based on a variety of factors including the
+Added: length of time the receivables are past due, the financial health of the customer and historical experience.
+Added: Based upon the review
+Added: of these factors, the Company recorded no allowance for doubtful accounts at December 31, 2022 or 2021.
+Added: The accounts receivable
+Added: balance at December 31, 2022 and 2021 and product sales revenue recognized during the year ended December 31, 2022 and 2021 consist
+Added: of sales to and amounts due from AmerisourceBergen Corporation, Cardinal Health Services and McKesson Corporation for sales of the
+Added: Company’s Biorphen product.
+Added: The December 31, 2022 accounts receivable balance and sales in 2022 also include amounts due from
+Added: AnovoRx for sales of the Company’s ALKINDI SPRINKLE® product and its Carglumic Acid product.
+Added: AnovoRx sales made up 45.5 %
+Added: of 2022 total net revenues and 79.8 %
+Added: of net accounts receivable as of December 31, 2022, and 9.0 % of 2021 total net revenues and 6.4 % of net accounts receivable as of December 31, 2021.
Recognition for Contracts with Customers
46 unchanged sentences
some or all of the royalty has been allocated has been satisfied or partially satisfied.
−Removed: To date, the Company has not recognized any
−Removed: royalty revenue resulting from any of its licensing arrangements.
Financing Component – In determining the transaction price, the Company will adjust consideration for the effects of the time
1 unchanged sentence
will be more than one year.
−Removed: Company sells Biorphen in the U.S.
−Removed: to wholesale pharmaceutical distributors, who then sell the product to hospitals and other end-user
−Removed: Sales to wholesalers are made pursuant to purchase orders subject to the terms of a master agreement, and delivery of individual
−Removed: shipments of Biorphen represent performance obligations under each purchase order.
−Removed: The Company uses a third-party logistics (“3PL”)
−Removed: vendor to process and fulfill orders and has concluded it is the principal in the sales to wholesalers because it controls access to
−Removed: the 3PL vendor services rendered and directs the 3PL vendor activities.
−Removed: The Company has no significant obligations to wholesalers to
−Removed: generate pull-through sales.
−Removed: In addition, the Company sells its Alkindi Sprinkle and Carglumic Acid product to one pharmacy distributor
−Removed: customer which provides order fulfilment and inventory storage/distribution services.
−Removed: prices initially billed to wholesalers are subject to discounts for prompt payment and subsequent chargebacks when the wholesalers sell
−Removed: Biorphen at negotiated discounted prices to members of certain group purchasing organizations (“GPOs”) and government programs.
−Removed: In addition, the Company pays fees to wholesalers for their distribution services, inventory reporting and chargeback processing.
−Removed: Company pays GPOs fees for administrative services and for access to GPO members and concluded the benefits received in exchange for
−Removed: these fees are not distinct from its sales of Biorphen, and accordingly it applies these amounts to reduce revenues.
−Removed: Wholesalers also
−Removed: have rights to return unsold product nearing or past the expiration date.
−Removed: Because of the shelf life of Biorphen and the Company’s
−Removed: lengthy return period, there may be a significant period of time between when the product is shipped and when it issues credits on returned
−Removed: For its Alkindi Sprinkle and Carglumic Acid products, the Company bills at the initial product list price which are subject
−Removed: to offsets for patient co-pay assistance and potential state Medicaid reimbursements which are recorded as a reduction of net revenues
−Removed: at the date of sale/shipment.
+Added: Company sells its ALKINDI SPRINKLE® and Carglumic Acid product to one pharmacy distributor customer which provides order fulfilment
+Added: and inventory storage/distribution services.
+Added: The Company may sell products in the U.S.
+Added: to wholesale pharmaceutical distributors, who
+Added: then sell the product to hospitals and other end-user customers.
+Added: Sales to wholesalers are made pursuant to purchase orders subject to
+Added: the terms of a master agreement, and delivery of individual shipments represent performance obligations under each purchase order.
+Added: Company uses a third-party logistics (“3PL”) vendor to process and fulfill orders and has concluded it is the principal in
+Added: the sales to wholesalers because it controls access to the 3PL vendor services rendered and directs the 3PL vendor activities.
+Added: has no significant obligations to wholesalers to generate pull-through sales.
+Added: its ALKINDI SPRINKLE® and Carglumic Acid products, the Company bills at the initial product list price which are subject to offsets
+Added: for patient co-pay assistance and potential state Medicaid reimbursements which are recorded as a reduction of net revenues at the date
+Added: of sale/shipment.
+Added: Selling prices initially billed to wholesalers are subject to discounts for prompt payment and subsequent chargebacks
+Added: when the wholesalers sell products at negotiated discounted prices to members of certain group purchasing organizations (“GPOs”)
+Added: and government programs.
+Added: Because of the shelf life of the product and the Company’s lengthy return period, there may be a significant
+Added: period of time between when the product is shipped and when it issues credits on returned product.
Company estimates the transaction price when it receives each purchase order taking into account the expected reductions of the selling
1 unchanged sentence
The Company has developed estimates for future
−Removed: returns and chargebacks of Biorphen and the impact of the other discounts and fees it pays while Alkindi Sprinkle and Carglumic Acid
−Removed: sales to its distributor are not subject to returns.
−Removed: When estimating these adjustments to the transaction price, the Company reduces
−Removed: it sufficiently to be able to assert that it is probable that there will be no significant reversal of revenue when the ultimate adjustment
−Removed: amounts are known.
−Removed: Company recognizes revenue from Biorphen product sales and related cost of sales upon product delivery to the wholesaler location.
−Removed: that time, the wholesalers take control of the product as they take title, bear the risk of loss of ownership, and have an enforceable
−Removed: obligation to pay the Company.
−Removed: They also have the ability to direct sales of product to their customers on terms and at prices they negotiate.
−Removed: Although wholesalers have product return rights, the Company does not believe they have a significant incentive to return the product.
−Removed: The Company stores its Alkindi Sprinkle and Carglumic Acid inventory at its pharmacy distributor customer location and sales are recorded
+Added: returns and chargebacks and the impact of other discounts and fees it pays, although ALKINDI SPRINKLE® and Carglumic Acid sales are
+Added: not subject to returns.
+Added: When estimating these adjustments to the transaction price, the Company reduces it sufficiently to be able to
+Added: assert that it is probable that there will be no significant reversal of revenue when the ultimate adjustment amounts are known.
+Added: Company stores its ALKINDI SPRINKLE® and Carglumic Acid inventory at its pharmacy distributor customer location, and sales are recorded
when stock is pulled and shipped to fulfill specific patient orders.
+Added: The Company recognizes revenue and cost of sales from products sold
+Added: to wholesalers upon delivery to the wholesaler location.
+Added: At that time, the wholesalers take control of the product as they take title,
+Added: bear the risk of loss of ownership and have an enforceable obligation to pay the Company.
+Added: They also have the ability to direct sales
+Added: of product to their customers on terms and at prices they negotiate.
+Added: Although wholesalers have product return rights, the Company does
+Added: not believe they have a significant incentive to return the product.
recognition of revenue from product sales, the estimated amounts of credit for product returns, chargebacks, distribution fees, prompt
−Removed: payment discounts, state Medicaid and GPO fees are included in sales reserves, accrued liabilities and net of accounts receivable.
−Removed: Company monitors actual product returns, chargebacks, discounts and fees subsequent to the sale.
−Removed: If these amounts end up differing from
−Removed: its estimates, it will make adjustments to these allowances, which are applied to increase or reduce product sales revenue and earnings
−Removed: in the period of adjustment.
+Added: payment discounts, state Medicaid and GPO fees are included in sales reserves, accrued liabilities and net accounts receivable.
+Added: monitors actual product returns, chargebacks, discounts and fees subsequent to the sale.
+Added: If these amounts end up differing from its estimates,
+Added: it will make adjustments to these allowances, which are applied to increase or reduce product sales revenue and earnings in the period
+Added: of adjustment.
addition, the Company anticipates it will receive revenues from product licensing agreements where it has contracted for milestone payments
−Removed: and royalties from products it has developed or for which it has acquired the rights to a product developed by a third party.
+Added: and royalties from products it has developed or acquired.
Pharmaceuticals, Inc.
3 unchanged sentences
of Product Sales
−Removed: of product sales consists of the profit-sharing and royalty fees with the Company’s product licensing and development partners,
−Removed: the purchase costs for finished products from third-party manufacturers and freight and handling/storage costs from the Company’s
−Removed: 3PL logistics service providers.
−Removed: The cost of sales for profit-sharing and royalty fees and costs for purchased finished products and
−Removed: the associated inbound freight expense is recorded when the associated product sale revenue is recognized in accordance with the terms
−Removed: of shipment to customers while outbound freight and handling/storage fees charged by the 3PL service provider are expensed as they are
−Removed: Cost of sales also reflects any write-downs or reserve adjustments for the Company’s inventories.
+Added: of product sales consists of the profit-sharing and royalty fees with the Company’s product licensing and development
+Added: partners, the purchase costs for finished products from third-party manufacturers, the amortization of certain intangible assets, and freight and handling/storage costs from the Company’s 3PL logistics service providers.
+Added: The cost of sales for
+Added: profit-sharing and royalty fees and costs for purchased finished products and the associated inbound freight expense is recorded
+Added: when the associated product sale revenue is recognized in accordance with the terms of shipment to customers while outbound freight
+Added: and handling/storage fees charged by the 3PL service provider are expensed as they are incurred.
+Added: Cost of sales also reflects any
+Added: write-downs or reserve adjustments for the Company’s inventories.
and Development Expenses
14 unchanged sentences
(Loss) Per Share
−Removed: net loss per common share is computed by dividing net loss attributable to common stockholders for the period by the weighted average
+Added: net income (loss) per common share is computed by dividing net income (loss) attributable to common stockholders for the period by the weighted average
number of common shares outstanding during the period.
−Removed: Diluted net loss per share is computed by dividing the net loss attributable to
+Added: Diluted net income (loss) per share is computed by dividing the net income (loss) attributable to
common stockholders for the period by the weighted average number of common and common equivalent shares, such as Series A Preferred,
5 unchanged sentences
earnings per share calculation would have been anti-dilutive (see Note 9).
−Removed: Basic weighted average shares for the year ended December
−Removed: 31, 2021 include 600,000 vested warrants to purchase common shares.
−Removed: As the shares underlying these warrants can be purchased for little
−Removed: to no consideration ($ 0.01 per share exercise price), they are included in the computation of basic earnings per share.
Company accounts for stock-based compensation under the provisions of ASC 718 Compensation — Stock Compensation.
53 unchanged sentences
31, 2022 or 2021.
−Removed: Pharmaceuticals, Inc.
−Removed: TO FINANCIAL STATEMENTS
−Removed: thousands, except share and per share amounts)
−Removed: 3 — Summary of Significant Accounting Policies (continued)
Value Measurements
11 unchanged sentences
use in pricing the asset or liability developed based on the best information available.
+Added: Pharmaceuticals, Inc.
+Added: TO FINANCIAL STATEMENTS
+Added: thousands, except share and per share amounts)
+Added: 3 — Summary of Significant Accounting Policies (continued)
value measurements are classified based on the lowest level of input that is significant to the measurement.
7 unchanged sentences
Company’s financial instruments included cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities
−Removed: PPP loan and long-term debt obligation.
−Removed: The carrying amounts of these financial instruments, except for the PPP loan and long-term debt
+Added: and long-term debt obligation.
+Added: The carrying amounts of these financial instruments, except for the long-term debt
obligation, approximate their fair values due to the short-term maturities of these instruments.
−Removed: Based on borrowing rates currently available
−Removed: to the Company, the carrying value of the PPP loan and long-term debt obligation approximate their respective fair values.
+Added: Based on borrowing rates currently
+Added: available to the Company, the carrying value of the long-term debt obligation approximate their respective fair
of New Accounting Pronouncements
−Removed: were no new accounting pronouncements issued by the FASB during the current period that would apply to the Company and have a material
−Removed: impact on its financial position or results of operations.
−Removed: Pharmaceuticals, Inc.
−Removed: TO FINANCIAL STATEMENTS
−Removed: thousands, except share and per share amounts)
+Added: were no new accounting pronouncements issued by the Financial Accounting Standards Board (“FASB”) during the current period
+Added: that would apply to the Company and have a material impact on its financial position or results of operations.
4 – Property and Equipment
1 unchanged sentence
Schedule of Property and Equipment
−Removed: hardware and software
+Added: Computer hardware and software
+Added: Furniture and fixtures
+Added: Leasehold improvements
+Added: Construction in progress
and equipment, gross
accumulated depreciation and amortization
−Removed: and equipment, net
−Removed: and amortization expense for the years ended December 31, 2021, 2020 and 2019 was $ 155 , $ 347 and $ 283 , respectively.
−Removed: The balances at
−Removed: December 31, 2021 reflect the sale of laboratory equipment in May 2021 which had a net book value of $ 519 .
+Added: Property and equipment, net
+Added: expense for the years ended December 31, 2022, 2021 and 2020 was $ 66 , $ 155 and $ 347 , respectively.
Pharmaceuticals, Inc.
6 unchanged sentences
In March 2020, in conjunction
−Removed: with the Company’s Alkindi Sprinkle product licensing agreement (see Note 14) and the Company’s March 2020 sale of additional
+Added: with the Company’s ALKINDI SPRINKLE® product licensing agreement (see Note 14) and the Company’s March 2020 sale of
shares of its common stock (see Note 6), the Company and SWK amended the SWK Credit Agreement.
3 unchanged sentences
Accordingly, the Company borrowed an additional $ 2,000 on August 11, 2020.
−Removed: term of the SWK Credit Agreement is for five years and borrowings bear interest at a rate of LIBOR 3-month plus 10.0 %, subject to a stated
−Removed: LIBOR floor rate of 2.0 %.
−Removed: A 2.0 % unused credit limit fee is assessed during the first twelve months after the date of the SWK Credit
−Removed: Agreement and loan fees include a 5.0 % exit fee based on the principal amounts drawn which is payable at the end of the term of the SWK
−Removed: Credit Agreement.
−Removed: The Company is required to maintain a minimum cash balance of $ 3,000 , only pay interest on the debt until February
−Removed: 2022 and then pay 5.5% of the loan principal balance commencing on February 15, 2022 and then every three months thereafter until November
−Removed: 13, 2024 at which time the remaining principal balance is due.
−Removed: Borrowings under the SWK Credit Agreement are secured by the Company’s
−Removed: The SWK Credit Agreement contains customary default provisions and covenants which include limits on additional indebtedness.
+Added: The term of the SWK Credit Agreement is for five years and borrowings bear interest at a rate of LIBOR 3-month plus 10.0 %, subject to
+Added: a stated LIBOR floor rate of 2.0 %.
+Added: A 2.0 % unused credit limit fee is assessed during the first twelve months after the date of the SWK
+Added: Credit Agreement and loan fees include a 5.0 % exit fee based on the principal amounts drawn which is payable at the end of the term of
+Added: the SWK Credit Agreement.
+Added: The Company was required to maintain a minimum cash balance of $ 3,000 , only pay interest on the debt until
+Added: February 2022 and then pay 5.5% of the loan principal balance commencing on February 15, 2022 and then every three months thereafter
+Added: until November 13, 2024 at which time the remaining principal balance is due.
+Added: Borrowings under the SWK Credit Agreement are secured by
+Added: the Company’s assets.
+Added: The SWK Credit Agreement contains customary default provisions and covenants which include limits on additional
+Added: indebtedness.
In March 2020, SWK provided a waiver for the Company to obtain loans with the Small Business Association.
−Removed: In February 2021, the Company
−Removed: notified SWK that it will not require additional borrowing capacity under the SWK Credit Agreement and terminated the additional borrowing
−Removed: capacity with SWK.
+Added: In February 2021,
+Added: the Company notified SWK that it will not require additional borrowing capacity under the SWK Credit Agreement and terminated the additional
+Added: borrowing capacity with SWK .
connection with the initial $ 5,000 borrowed in November 2019, the Company issued warrants to SWK to purchase 51,239 shares of the Company’s
20 unchanged sentences
in connection with stock splits, dividends, reclassifications and other conditions.
−Removed: Company recorded interest expense of $ 1,042 , $ 884 and $ 98 in 2021, 2020 and 2019, respectively, which included $ 148 $ 121 and $ 16 , respectively,
−Removed: of debt discount amortization.
−Removed: The Company had accrued interest of $ 134 and $ 48 as of December 31, 2021 and 2020, respectively, which
−Removed: is included in accrued liabilities in the accompanying balance sheets.
+Added: April 5, 2022, the Company and SWK entered into an amendment to the SWK Credit Agreement which allowed for a deferral of loan principal
+Added: payments until May 2023 and reduced the interest rate to LIBOR 3-month plus 8.0 %, subject to a stated LIBOR floor rate of 2.0 %.
+Added: In accordance
+Added: with the change, the Company has classified $ 1,033 as principal due in the next 12 months and the remainder classified as long-term debt
+Added: in its balance sheet at December 31, 2022.
+Added: Because LIBOR was intended to be phased out by the end of 2021, future borrowings under our
+Added: Credit Agreement could be subject to reference rates other than LIBOR.
+Added: However, the cessation date of LIBOR has been deferred to June
+Added: 30, 2023 and we do not expect the planned discontinuation of LIBOR to have a material impact on interest payments incurred under the
+Added: SWK Credit Agreement.
+Added: The Company is in discussions with SWK regarding an alternate reference rate.
+Added: Company recorded interest expense of $ 955 , $ 1,042 and $ 884 in 2022, 2021 and 2020, respectively, which included $ 127 , $ 148 and $ 121 ,
+Added: respectively, of debt discount amortization.
+Added: The Company had accrued interest of $ 231 and $ 134 as of December 31, 2022 and 2021, respectively,
+Added: which is included in accrued liabilities in the accompanying balance sheets.
Pharmaceuticals, Inc.
4 unchanged sentences
Schedule of Future Payments of Long Term Debt
+Added: Total payments
amount representing interest
−Removed: payable, gross
+Added: Loan payable, gross
current portion of long-term debt
unamortized discount
−Removed: debt, net of unamortized discount
+Added: Long-term debt, net of unamortized discount
May 4, 2020, the Company received $ 361 in loan proceeds under the Paycheck Protection Program (“PPP”) from the Small Business
5 unchanged sentences
The Company paid off the full EIDL loan principal and its cumulative interest of $6 in July 2021.
−Removed: Pharmaceuticals, Inc.
−Removed: TO FINANCIAL STATEMENTS
−Removed: thousands, except share and per share amounts)
6 — Common Stock
9 unchanged sentences
received net proceeds of $ 21,026 .
−Removed: the years ended December 31, 2021 and 2020, the Company issued 144,233
−Removed: shares, respectively, of its common stock resulting
−Removed: from stock option exercises under its 2018 Equity Incentive Plan (see Note 8).
−Removed: For the years ended December 31, 2021 and 2020, the Company
−Removed: issued 49,155
−Removed: shares, respectively, under the Company’s
−Removed: Employee Stock Purchase Program (“ESPP”).
−Removed: In April 2020, the Company issued 15,190
−Removed: shares of its common stock as an RSA to a new
−Removed: This RSA vested 25 %
−Removed: every three months and was 100 %
−Removed: vested in April 2021.
−Removed: In April 2021, the Company issued 25,000
−Removed: shares of its common stock to a member of its
−Removed: board of directors upon his retirement from the board in connection with previously vested restricted stock units (“RSUs”).
−Removed: During 2021, there were 135,650
−Removed: warrants exercised (all on a cashless basis)
−Removed: resulting in 94,808
−Removed: shares of common stock being issued by the Company.
Pharmaceuticals, Inc.
1 unchanged sentence
thousands, except share and per share amounts)
−Removed: Note 7 — Common Stock Warrants
+Added: 6 — Common Stock (continued)
+Added: the years ended December 31, 2022 and 2021, the Company issued 25,000 and 144,233 shares, respectively, of its common stock resulting
+Added: from stock option exercises under its 2018 Equity Incentive Plan (see Note 8).
+Added: For the years ended December 31, 2022 and 2021, the Company
+Added: issued 69,884 and 49,155 shares, respectively, under the Company’s Employee Stock Purchase Plan (“ESPP”).
+Added: 2020, the Company issued 15,190 shares of its common stock as an RSA to a new employee.
+Added: This RSA vested 25 % every three months and was
+Added: 100 % vested in April 2021.
+Added: In April 2021, the Company issued 25,000 shares of its common stock to a member of its board of directors
+Added: upon his retirement from the board in connection with previously vested RSUs.
+Added: During 2022, there
+Added: were 1,067,242 warrants exercised, a portion of which was a cashless exercise, resulting in 632,231 shares of common stock being issued
+Added: by the Company.
+Added: 7 — Common Stock Warrants
below is a summary of warrants outstanding as of December 31, 2022:
Summary of Warrants Outstanding
−Removed: Advisory Warrants – 2017
−Removed: Agent Warrants – 2017 Preferred Stock Offering
−Removed: Agent Warrants - IPO
−Removed: Warrants – Debt (Tranche #1)
−Removed: Warrants – Debt (Tranche #2)
+Added: Description of Warrants
+Added: Exercise Price
+Added: Placement Agent Warrants - IPO
+Added: SWK Warrants – Debt (Tranche #1)
+Added: SWK Warrants – Debt (Tranche #2)
holders of these warrants or their permitted transferees, are entitled to rights with respect to the registration under the Securities
1 unchanged sentence
rights are provided under the terms of a registration rights agreement between the Company and the investors.
+Added: June 26, 2022, 467,242 warrants from the 2017 preferred stock offering with an exercise price of $ 3.00 were set to expire.
+Added: expiration, the Company entered into an agreement with the warrant holders, whereby it modified the terms of the warrants to extend the
+Added: expiration date until December 26, 2022 in exchange for the Company retaining the option of a cashless exercise provision.
+Added: No other terms
+Added: were modified.
+Added: Due to this modification, the Company incurred a modification expense of $ 244 that is included in general and administration
+Added: expense on the Statement of Operations for the year ended December 31, 2022.
rollforward of the warrants outstanding is listed in the table below:
Summary of Rollforward of The Warrants Outstanding
−Removed: as of the beginning of the year
−Removed: of Placement Agent Warrants – 2017 Preferred Stock Offering
−Removed: as of the end of the year
−Removed: were 135,650 warrants exercised (all on a cashless basis) in 2021 resulting in 94,808 shares of common stock being issued by the Company.
−Removed: There were no warrant exercises is 2020.
−Removed: The intrinsic value of the warrants exercised in 2021 was $ 806 .
+Added: Balance as of the beginning of the year
+Added: Exercise of Placement Agent Warrants – 2017 Preferred Stock Offering
+Added: ( 1,067,242 )
+Added: Expiration of Placement Agent Warrants – 2017 Preferred Stock Offering
+Added: Balance as of the end of the year
+Added: were 1,067,242 warrants exercised in 2022 resulting in 632,231 shares of common stock being issued by the Company.
+Added: There were 135,650
+Added: warrants exercised in 2021 (all on a cashless basis) resulting in 94,808 shares of common stock being issued by the Company.
+Added: The intrinsic
+Added: value of the warrants exercised was $ 2,367 in 2022 and $ 806 in 2021.
8 — Share-Based Payment Awards
Company’s board of directors and stockholders approved the Eton Pharmaceuticals, Inc.
−Removed: 2017 Equity Incentive Plan in May 2017 (the
−Removed: “2017 Plan”), which authorized the issuance of up to 5,000,000 shares of the Company’s common stock.
−Removed: In conjunction
−Removed: with the Company’s IPO in November 2018, the Company’s stockholders and board of directors approved the 2018 Equity Incentive
−Removed: Plan, as amended (the “2018 Plan”) which succeeded the 2017 Plan.
−Removed: The Company has granted RSAs, stock options and RSUs for
−Removed: its common stock under the 2017 Plan and 2018 Plan as detailed in the tables below.
−Removed: There were 537,306 shares available for future issuance
−Removed: under the 2018 Plan as of December 31, 2021.
+Added: 2017 Equity Incentive Plan in May 2017
+Added: (the “2017 Plan”), which authorized the issuance of up to 5,000,000
+Added: shares of the Company’s common stock.
+Added: In conjunction with the Company’s IPO in November 2018, the Company’s
+Added: stockholders and board of directors approved the 2018 Equity Incentive Plan, as amended (the “2018 Plan”) which
+Added: succeeded the 2017 Plan.
+Added: The Company has granted RSAs, stock options and RSUs for its common stock under the 2017 Plan and 2018 Plan
+Added: as detailed in the tables below.
+Added: There were 239,167 shares
+Added: available for future issuance under the 2018 Plan as of December 31, 2022.
+Added: Pharmaceuticals, Inc.
+Added: TO FINANCIAL STATEMENTS
+Added: thousands, except share and per share amounts)
+Added: 8 — Share-Based Payment Awards (continued)
that are expired, terminated, surrendered or canceled without having been fully exercised will be available for future awards under the
8 unchanged sentences
shares based on the 24,312,808 shares of common stock outstanding at December 31, 2020.
−Removed: The exercise price for stock options granted
−Removed: is not less than the fair value of common stock as determined by the board of directors as of the date of grant.
−Removed: The Company uses the
−Removed: closing stock price on the date of grant as the exercise price.
−Removed: Pharmaceuticals, Inc.
−Removed: TO FINANCIAL STATEMENTS
−Removed: thousands, except share and per share amounts)
−Removed: 8 — Share-Based Payment Awards (continued)
+Added: On January 1, 2022, the share reserve was increased
+Added: by 985,040 shares based on the 24,626,004 shares of common stock outstanding at December 31, 2021.
+Added: The exercise price for stock options
+Added: granted is not less than the fair value of common stock as determined by the board of directors as of the date of grant.
+Added: uses the closing stock price on the date of grant as the exercise price.
April 2020, the Company issued 15,190 shares of its common stock as an RSA to a new employee.
3 unchanged sentences
at the dates of grant.
−Removed: Options generally have a ten -year life, except for options to purchase 50,000 shares of the Company’s common
−Removed: stock granted to product consultants that expire within five years if the Company is not able to successfully file certain product submissions
−Removed: to the FDA prior to the five-year expiration date.
−Removed: Furthermore, these option awards to the Company’s product consultants do not
−Removed: vest unless certain product submissions are made to the FDA, and accordingly, the Company has not recorded any expense for these contingently
−Removed: vesting option awards to its product consultants.
+Added: Options typically have a ten -year life, except for options to purchase 50,000 shares of the Company’s common
+Added: stock granted to product consultants in July 2017 that expired, unexercised, in July 2022 as the Company was not able to file certain
+Added: product submissions to the FDA prior to the five -year expiration date.
+Added: Furthermore, these option awards to the Company’s product
+Added: consultants would not vest unless certain product submissions are made to the FDA, and accordingly, the Company has not recorded any
+Added: expense for these contingently vesting option awards to its product consultants.
+Added: July 2022 and September 2022, the Company’s board of directors approved modifications of certain outstanding awards of two senior
+Added: executives, one of whom retired in May 2022 and the other whose employment was terminated in July 2022.
+Added: The combined awards had an exercise
+Added: price range of $ 1.37 to $ 8.61 which were set to expire 90 days after retirement or termination as the case may be, and the Company extended
+Added: the expiration dates to April 2023.
+Added: No other terms were modified.
+Added: Due to these modifications, the Company incurred a modification expense
+Added: of approximately $ 104 that is included in general and administration expense on the Statement of Operations for the year
+Added: ended December 31, 2022.
the years ended December 31, 2022, 2021, and 2020, the Company’s total stock-based compensation expense was $ 4,218 , $ 3,381 and
2 unchanged sentences
and $ 264 , $ 543 and $ 281 was recorded in R&D expenses, respectively.
−Removed: summary of stock option activity is as follows:
+Added: following table summarizes stock option activity during the year ended December 31, 2022:
Summary of Stock Option Activity
−Removed: Average Exercise
−Removed: Average Remaining
−Removed: outstanding as of January 1, 2021
+Added: Weighted Average Exercise
+Added: Weighted Average Remaining
+Added: Aggregate Intrinsic
+Added: Options outstanding as of January 1, 2022
Forfeited/Cancelled
−Removed: outstanding as of December 31, 2021
−Removed: exercisable at December 31, 2021
−Removed: vested and expected to vest at December 31, 2021
+Added: Options outstanding as of December 31, 2022
+Added: Options exercisable at December 31, 2022
+Added: Options vested and expected to vest at December 31, 2022
aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair
2 unchanged sentences
The intrinsic value of the options exercised during 2022 was $ 31 .
−Removed: were 144,233 shares issued for exercise of stock options during the year ended December 31, 2021 for proceeds of $ 339 .
−Removed: assumptions used to calculate the fair value of options granted during the years ended December 31, 2021, 2020, and 2019 under the BSM
−Removed: were as follows:
−Removed: Schedule of Assumptions Used to Calculate Fair Value of Options Granted
−Removed: interest rate
−Removed: average fair value
Pharmaceuticals, Inc.
2 unchanged sentences
8 — Share-Based Payment Awards (continued)
+Added: were 25,000 shares issued for exercise of stock options during the year ended December 31, 2022 for proceeds of $ 35 .
+Added: assumptions used to calculate the fair value of options granted during the years ended December 31, , 2022, 2021, and 2020 under the
+Added: BSM were as follows:
+Added: Schedule of Assumptions Used to Calculate Fair Value of Options Granted
+Added: December 31, 2022
+Added: December 31, 2021
+Added: December 31, 2020
+Added: Expected dividends
+Added: Expected volatility
+Added: Risk-free interest rate
+Added: Expected term
+Added: Weighted average fair value
Term — The Company has opted to use the “simplified method” for estimating the expected term of options granted to
15 unchanged sentences
value of Common Stock —The Company uses the closing stock price on the date of grant for the fair value of the common stock.
−Removed: summary of activity for RSAs is as follows:
+Added: of December 31, 2022, there was a total of $ 3,868 of unrecognized compensation costs related to non-vested stock option awards which
+Added: will be recognized over a weighted average period of 2 years.
+Added: Stock Units (RSUs)
+Added: following table summarizes restricted stock unit activity during the year ended December 31, 2022:
Summary of Activity for Restricted Stock Awards
−Removed: as of January 1, 2021
−Removed: Forfeited/Cancelled
−Removed: as of December 31, 2021
−Removed: grant date fair value per share for the RSA issued in 2020 was $ 3.95 .
−Removed: No RSAs were issued in 2021 or 2019.
−Removed: The fair value of the RSAs
−Removed: vested during the years ended December 31, 2021, 2020 and 2019 was $ 30 , $ 30 and $ 66 , respectively.
−Removed: of December 31, 2021, there was a total of $ 6,025 of unrecognized compensation costs related to non-vested stock option awards.
+Added: Number of Units
+Added: Weighted Average Grant-Date Fair Value Per Unit
+Added: Outstanding and unvested as of January 1, 2022
+Added: Outstanding and unvested as of December 31, 2022
+Added: compensation related to RSUs was $ 114 for the year ended December 31, 2022.
+Added: As of December 31, 2022, there was $ 858 of unrecognized stock-based
+Added: compensation expense related to unvested RSUs which will be recognized over a weighted average period of 3.5 years.
Pharmaceuticals, Inc.
2 unchanged sentences
8 — Share-Based Payment Awards (continued)
+Added: Employee Stock Purchase Plan
December 2018, the Company’s board of directors adopted an initial offering of the Company’s common stock under the Company’s
2 unchanged sentences
reduction at the discretion of the Company’s board of directors .
−Removed: initial offering began on December 17, 2018 and ended on December 10, 2019.
−Removed: The initial offering consisted of two purchase periods, with
−Removed: the first purchase period ended on June 10, 2019 and the second purchase period ended on December 10, 2019.
−Removed: The terms of the ESPP permit
−Removed: employees of the Company to use payroll deductions to purchase stock at a price per share that is at least the lesser of (1) 85% of the
−Removed: fair market value of a share of common stock on the first date of an offering or (2) 85% of the fair market value of a share of common
−Removed: stock on the date of purchase.
−Removed: After the initial offering period, subsequent twelve-month offering periods automatically commence over
−Removed: the term of the ESPP on the day that immediately follows the conclusion of the preceding offering, each consisting of two purchase periods
−Removed: approximately six months in duration ending on or around June 10 and December 10 each year, subject to a restart feature if the Company’s
−Removed: stock price drops at the end of a six-month period within the twelve-month offering period .
+Added: terms of the ESPP permit employees of the Company to use payroll deductions to purchase stock at a price per share that is at least the
+Added: lesser of (1) 85% of the fair market value of a share of common stock on the first date of an offering or (2) 85% of the fair market
+Added: value of a share of common stock on the date of purchase.
+Added: After the initial offering period, subsequent twelve-month offering periods
+Added: automatically commence over the term of the ESPP on the day that immediately follows the conclusion of the preceding offering, each consisting
+Added: of two purchase periods approximately six months in duration ending on or around June 10 and December 10 each year, subject to a restart
+Added: feature if the Company’s stock price drops at the end of a six-month period within the twelve-month offering period .
Company recorded an expense of $ 128 , $ 73 and $ 71 in 2022, 2021, and 2020, respectively, related to the ESPP.
−Removed: The weighted average grant
−Removed: date fair value of share awards in 2021, 2020 and 2019 was $ 2.50 , $ 2.32 and $ 2.56 per share, respectively.
−Removed: Employees contributed $ 205
−Removed: and $ 115 to the ESPP during 2021 and 2020, respectively.
−Removed: Of these amounts, $ 22 and $ 18 at December 31, 2021 and 2020, respectively, is
−Removed: included in accrued liabilities in the accompanying balance sheets.
+Added: For the years ended December
+Added: 31, 2022 and 2021, there were 69,884 and 49,155 share issuances, respectively, under the ESPP.
+Added: The weighted average grant date fair value
+Added: of share awards in 2022, 2021, and 2020 was $ 1.17 , $ 2.50 and $ 2.32 per share, respectively.
+Added: Employees contributed $ 234 and $ 205 to the
+Added: ESPP during 2022 and 2021, respectively.
+Added: Of these amounts, $ 23 and $ 22 at December 31, 2022 and 2021, respectively, are included in accrued
+Added: liabilities in the accompanying balance sheets.
+Added: As of December 31, 2022, there were 560,296 shares available for issuance under the ESPP.
9 — Basic and Diluted Net Loss per Common Share
7 unchanged sentences
following table shows the computation of basic and diluted net loss per common share:
−Removed: Computation of Basic and Diluted Net Loss Per Common Share
−Removed: average common shares outstanding (basic and diluted)
−Removed: loss per common share (basic and diluted)
+Added: of Basic and Diluted Net Loss Per Common Share
+Added: Weighted average common shares outstanding (basic and diluted)
+Added: Net loss per common share (basic and diluted)
Pharmaceuticals, Inc.
2 unchanged sentences
10 — Related-Party Transactions
−Removed: was issued 3,500,000
−Removed: shares of the Company’s common stock at
−Removed: the formation of the Company at the $ 0.001
−Removed: par value per share price as the paid-in-capital
−Removed: contribution from Harrow.
−Removed: In April 2021, Harrow sold 1,518,000
−Removed: shares of the Eton common stock it owned in an
−Removed: underwritten public offering.
−Removed: As of December 31, 2021, Harrow owned 1,982,000
+Added: Chief Executive Officer of Harrow Health, Inc.
+Added: (“Harrow”) was a member of the Company’s board of directors until March
+Added: 17, 2021 when he retired from service with the board.
+Added: The Company issued 25,000
+Added: shares to the Harrow CEO in April 2021 after
+Added: his retirement from the Company’s board associated with RSUs that were previously fully vested.
+Added: As of December 31, 2022, Harrow
+Added: owned 1,982,000
shares of Eton’s common shares which represents
of the Company’s common shares outstanding.
−Removed: The Company and Harrow signed licensing agreements for two products developed
−Removed: by Harrow whereby Harrow assigned the product rights to the Company.
−Removed: In July 2018, the Company determined that one of the products was
−Removed: not viable for its portfolio of product opportunities and cancelled the licensing agreement whereby Harrow retains the product rights.
−Removed: May 6, 2019, the Company entered into an Asset Purchase Agreement (the “CT-100 Asset Purchase Agreement”) with Harrow.
−Removed: to the CT-100 Asset Purchase Agreement, the Company sold all of its right, title and interest in CT-100 to Harrow, including any such
−Removed: product that incorporates or utilizes its intellectual property rights (a “Product” or, collectively, “Products”).
−Removed: Pursuant to the CT-100 Asset Purchase Agreement, Harrow will make certain payments to the Company upon the achievement of certain development
−Removed: and commercial milestones.
−Removed: In addition, Harrow is required to pay the Company a royalty in the low-single digit percentage range worldwide
−Removed: on a country-by-country basis on net sales for a period of the longer of 15 years from the date of the first commercial sale of a product
−Removed: in a particular country or the time that a valid intellectual property claim on such Product remains in force in the applicable country.
−Removed: The CT-100 Asset Purchase Agreement also contains customary representations, warranties, covenants and indemnities by the parties.
−Removed: date, there have not been any sales of the CT-100 product and therefore no earned royalties to the Company for this product.
−Removed: Additionally,
−Removed: the Chief Executive Officer of Harrow was a member of the Company’s board of directors until March 17, 2021 when he retired from
−Removed: service with the board.
−Removed: The Company issued 25,000 shares to the Harrow CEO in April 2021 after his retirement from the Company’s
−Removed: board associated with RSU’s that were previously fully vested.
−Removed: late March 2021, the Company closed its laboratory operation in Lake Zurich, Illinois and in May 2021 it reached an agreement for Imprimis
−Removed: Pharmaceuticals, a subsidiary of Harrow, to purchase its lab equipment for $ 700 which was $ 181 above the Company’s net book value
−Removed: of the equipment.
−Removed: Executive Officer
−Removed: CEO has a partial interest in a company that the Company has partnered with for its EM-100 product as described below.
−Removed: Company acquired the exclusive rights to sell the EM-100 product in the United States pursuant to a sales and marketing agreement (the
−Removed: “Eyemax Agreement”) dated August 11, 2017 between the Company and Eyemax LLC (“Eyemax”), an entity affiliated
−Removed: with the Company’s CEO.
−Removed: The Company also held a right of first refusal to obtain the exclusive license rights for geographic areas
−Removed: outside of the United States.
−Removed: Pursuant to the Eyemax Agreement, the Company was responsible for all costs of testing and FDA approval
−Removed: of the product, other than the FDA filing fee which was paid by Eyemax.
−Removed: The Company was also to be responsible for commercializing the
−Removed: product in the United States at its expense.
−Removed: The Company paid Eyemax $ 250 upon execution of the Eyemax Agreement, which was recorded
−Removed: as a component of R&D expense.
−Removed: Under the terms of the original agreement, the Company would pay Eyemax $ 250 upon FDA approval and
−Removed: $ 500 upon the first commercial sale of the product and pay Eyemax a royalty of 10 % on the net sales of all products.
−Removed: The Eyemax Agreement
−Removed: was for an initial term of 10 years from the date of the Eyemax Agreement, subject to successive two-year renewals unless the Company
−Removed: elected to terminate the Eyemax Agreement .
−Removed: There were no amounts due under the terms of the Eyemax Agreement as of December 31, 2021
−Removed: Pharmaceuticals, Inc.
−Removed: TO FINANCIAL STATEMENTS
−Removed: thousands, except share and per share amounts)
−Removed: 10 — Related Party Transactions (continued)
+Added: In March 2021, the Company closed its laboratory operation in Lake Zurich, Illinois
+Added: and in May 2021 it reached an agreement for Imprimis Pharmaceuticals, a subsidiary of Harrow, to purchase its lab equipment for $ 700 which
+Added: was $ 181 above the Company’s net book value of the equipment.
+Added: Chief Executive Officer
+Added: The CEO has a partial interest
+Added: in a company that the Company has partnered with for its EM-100/Alaway Preservative Free eye allergy product as described below.
+Added: The Company acquired the exclusive
+Added: rights to sell the EM-100 product in the United States pursuant to a sales and marketing agreement (the “Eyemax Agreement”)
+Added: dated August 11, 2017 between the Company and Eyemax LLC (“Eyemax”), an entity affiliated with the Company’s CEO.
+Added: Company also held a right of first refusal to obtain the exclusive license rights for geographic areas outside of the United States.
+Added: to the Eyemax Agreement, the Company was responsible for all costs of testing and FDA approval of the product, other than the FDA filing
+Added: fee which was paid by Eyemax.
+Added: The Company was also to be responsible for commercializing the product in the United States at its expense.
+Added: The Company paid Eyemax $ 250 upon execution of the Eyemax Agreement, which was recorded as a component of R&D expense.
+Added: the terms of the original agreement, the Company would pay Eyemax $ 250 upon FDA approval and $ 500 upon the first commercial
+Added: sale of the product and pay Eyemax a royalty of 10 % on the net sales of all products.
+Added: The Eyemax Agreement was for an initial
+Added: term of 10 years from the date of the Eyemax Agreement, subject to successive two-year renewals unless the Company elected to
+Added: terminate the Eyemax Agreement .
February 18, 2019, the Company entered into an Amended and Restated Agreement with Eyemax amending the Sales Agreement (the “Amended
5 unchanged sentences
Pursuant to the Amended Agreement, the Company paid Eyemax two milestone payments:
−Removed: (i) one milestone payment for $ 250 upon regulatory
−Removed: approval in the territory by the FDA of the first single agent product and (ii) one milestone payment for $ 500 following the first commercial
−Removed: sale of the first single agent product in the territory.
−Removed: Following payment of the milestones, the Company is entitled to retain all of
−Removed: the non-royalty transaction revenues and royalties up to $ 2,000 (the “Recovery Amount”).
−Removed: After the Company has retained the
−Removed: full Recovery Amount, it is entitled to retain half of all royalty and non-royalty transaction revenue.
+Added: (i) one milestone payment for $ 250 upon
+Added: regulatory approval in the territory by the FDA of the first single agent product and (ii) one milestone payment for $ 500 following
+Added: the first commercial sale of the first single agent product in the territory.
+Added: Following payment of the milestones, the Company is entitled
+Added: to retain all of the non-royalty transaction revenues and royalties up to $ 2,000 (the
+Added: “Recovery Amount”).
+Added: After the Company has retained the full Recovery Amount, it is entitled to retain half of all royalty
+Added: and non-royalty transaction revenue.
The Company has realized $ 1,818
of the non-royalty and royalty revenue as of December 31, 2022.
−Removed: The Amended Agreement also contains customary representations, warranties,
−Removed: covenants and indemnities by the parties.
−Removed: The EM-100 asset and its associated product rights were sold to Bausch Health on February 18,
−Removed: 2019 and future potential royalties of twelve percent on Bausch Health sales of EM-100, which was approved by the FDA in September 2020,
−Removed: will be split between Eyemax and the Company.
−Removed: The royalty from Bausch Health is subject to reduction if a competitive product with the
−Removed: same active pharmaceutical ingredient is launched in the U.S.
−Removed: or if the EM-100 U.S market share falls below a specified target percentage.
−Removed: There were no amounts due Eyemax under the terms of the Amended Agreement as of December 31, 2021 or 2020.
−Removed: Pharmaceuticals, Inc.
−Removed: TO FINANCIAL STATEMENTS
−Removed: thousands, except share and per share amounts)
+Added: The Amended Agreement also
+Added: contains customary representations, warranties, covenants and indemnities by the parties.
+Added: The EM-100 asset and its associated product
+Added: rights were sold to Bausch Health on February 18, 2019 and future potential royalties of twelve percent on Bausch Health sales of the
+Added: product, named Alaway ® Preservative Free by Bausch, which
+Added: was approved by the FDA in September 2020, will be split between Eyemax and the Company.
+Added: The royalty from Bausch Health is subject to
+Added: reduction if a competitive product with the same active pharmaceutical ingredient is launched in the U.S.
+Added: or if the product’s U.S
+Added: market share falls below a specified target percentage.
+Added: There were no amounts due to Eyemax under the terms of the Amended Agreement as of Dec ember
+Added: 31, 2022 or December 31, 2021.
Company recognizes a right-of-use (“ROU”) asset and a lease liability on the balance sheet for substantially all leases,
5 unchanged sentences
its office lease for a two-year period through March 31, 2023 and recorded $ 195 in ROU assets and $ 195 in operating lease liabilities
−Removed: associate with the lease extension.
−Removed: On March 7, 2018, the Company entered into a lease for laboratory space at a complex in Lake Zurich,
−Removed: The lease commenced on March 7, 2018 and was scheduled to expire in February 2021.
−Removed: In November 2020, this laboratory lease
−Removed: was extended to June 2021 and was not extended after that date as the Company completed an evaluation its laboratory operations requirements
−Removed: and determined it would discontinue the laboratory activities and outsource its requirements.
+Added: in association with the lease extension.
+Added: In November 2022, the Company renewed its office lease for a two-year period through March 31,
+Added: 2025 and recorded $ 188 in ROU assets and $ 188 in operating lease liabilities in association with the lease extension.
+Added: On March 7, 2018,
+Added: the Company entered into a lease for laboratory space at a complex in Lake Zurich, Illinois.
+Added: The lease commenced on March 7, 2018 and
+Added: was scheduled to expire in February 2021.
+Added: In November 2020, this laboratory lease was extended to June 2021 and was not extended after
+Added: that date as the Company completed an evaluation its laboratory operations requirements and determined it would discontinue the laboratory
+Added: activities and outsource its requirements.
Company does not have any lease contracts that contain:
11 unchanged sentences
2020, the new discount rate for the office lease extension was estimated at 5.4 %.
−Removed: The incremental borrowing rate was estimated by determining
−Removed: the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term an amount equal to the
−Removed: lease payments in a similar economic environment.
−Removed: the years ended December 31, 2021, 2020 and 2019, the Company recorded $ 113 , $ 139 , and $ 140 , respectively, in rent expense.
+Added: In November 2022, the new discount rate for an additional
+Added: office lease extension was estimated at 8.6 %.
+Added: The incremental borrowing rate was estimated by determining the rate of interest that the
+Added: Company would have to pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar
+Added: economic environment.
Company’s operating lease cost as presented in the “Research and Development” and “General and Administrative”
−Removed: captions in the statements of operations was $ 9 ,
−Removed: for the years ended December 31, 2021, 2020 and
+Added: captions in the statements of operations was $ 0 , $ 9 and $ 55 and $ 82 , $ 86 and $ 84 for the years ended December 31, 2022, 2021 and 2020,
respectively.
−Removed: Cash paid for amounts included in the measurement of operating lease liabilities was $ 83
−Removed: for years ended December 31, 2021 and 2020, respectively.
−Removed: The ROU asset amortization for years ended December 31, 2021, 2020 and 2019 was $ 88 ,
−Removed: respectively, and is reflected in depreciation and amortization in the Company’s statements of cash flows.
−Removed: As of December 31, 2021,
−Removed: the weighted-average remaining lease term was 1.25
−Removed: years, and the weighted-average discount rate
+Added: For the years ended December 31, 2022, 2021, and 2020, the Company recorded $ 87 , $ 113 , and $ 139 , respectively, in rent
+Added: Cash paid for amounts included in the measurement of operating lease liabilities was $ 88 and $ 83 for years ended December 31,
+Added: 2022 and 2021, respectively.
+Added: The ROU asset amortization for years ended December 31, 2022, 2021, and 2020 was $ 82 , $ 88 and $ 129 , respectively,
+Added: and is reflected in depreciation and amortization in the Company’s statements of cash flows.
+Added: As of December 31, 2022, the weighted-average
+Added: remaining lease term was 2.25 years, and the weighted-average discount rate was 8.6 %.
+Added: Pharmaceuticals, Inc.
+Added: TO FINANCIAL STATEMENTS
+Added: thousands, except share and per share amounts)
+Added: 11 — Leases (continued)
table below presents the lease-related assets and liabilities recorded on the balance sheet as of December 31, 2022:
−Removed: Schedule of Lease-related Assets and Liabilities
+Added: of Lease-related Assets and Liabilities
Classification
−Removed: lease right-of-use assets
−Removed: lease right-of-use assets, net
−Removed: leased assets
−Removed: lease liabilities, current
−Removed: lease liabilities, noncurrent
−Removed: lease liabilities, net of current portion
−Removed: operating lease liabilities
+Added: Operating lease right-of-use assets
+Added: Operating lease right-of-use assets, net
+Added: Total leased assets
+Added: Operating lease liabilities, current
+Added: Accrued liabilities
+Added: Operating lease liabilities, noncurrent
+Added: Operating lease liabilities, net of current portion
+Added: Total operating lease liabilities
Company’s future annual lease commitments as of December 31, 2022 are as indicated below:
of Future Lease Commitments
−Removed: lease payments
+Added: Undiscounted lease payments
Imputed interest
−Removed: lease liabilities
−Removed: Pharmaceuticals, Inc.
−Removed: TO FINANCIAL STATEMENTS
−Removed: thousands, except share and per share amounts)
+Added: Total lease liabilities
12 – Income Taxes
provision for income taxes for the Company consists of the following for the years ended December 31, 2022, 2021 and 2020:
−Removed: Schedule of Provision for Income Taxes
−Removed: current expense
−Removed: in valuation allowance
−Removed: deferred expense
+Added: of Provision for Income Taxes
+Added: Total current expense
+Added: Change in valuation allowance
+Added: Total deferred expense
+Added: Total provision
income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes.
−Removed: significant components of the Company’s deferred tax assets as of December 31, 2021 and 2020 are as follows:
−Removed: Schedule of Deferred Tax Assets
−Removed: operating losses
−Removed: deferred tax assets
−Removed: deferred tax assets
−Removed: on the uncertainty of future taxable income at this time management believes a 100 %
−Removed: valuation reserve for the $ 18,548
−Removed: deferred tax assets at December 31, 2021 and
−Removed: 2020, respectively, is appropriate.
−Removed: reconciliation of the statutory federal tax rate to effective tax rate is shown below:
−Removed: Schedule of Reconciliation of Statutory Federal Tax Rate
−Removed: ended December 31
−Removed: ended December 31,
−Removed: at statutory rate
−Removed: items (primarily warrants and stock compensation)
−Removed: Establishment
−Removed: of valuation allowance
Pharmaceuticals, Inc.
2 unchanged sentences
12 – Income Taxes (continued)
+Added: significant components of the Company’s deferred tax assets as of December 31, 2022 and 2021 are as follows:
+Added: of Deferred Tax Assets
+Added: Net operating losses
+Added: Stock-based expenses
+Added: Accruals and other
+Added: Total deferred tax assets
+Added: Valuation allowance
+Added: Net deferred tax assets
+Added: on the uncertainty of future taxable income at this time management believes a 100 % valuation reserve for the $ 21,632 and $ 18,548 deferred
+Added: tax assets at December 31, 2022 and 2021, respectively, is appropriate.
+Added: reconciliation of the statutory federal tax rate to effective tax rate is shown below:
+Added: of Reconciliation of Statutory Federal Tax Rate
+Added: Year ended December 31
+Added: Year ended December 31,
+Added: Benefit at statutory rate
+Added: Permanent items (primarily warrants and stock compensation)
+Added: State tax benefit
+Added: Federal rate change
+Added: Increase in valuation allowance
+Added: Income tax expense
Company has a federal and state NOL carryforward of $ 60,281
as of December 31, 2022.
−Removed: Under the Tax Act,
−Removed: federal NOLs incurred in taxable years ending after December 31, 2017 in the amount of $ 50,023
−Removed: may be carried forward indefinitely, but
−Removed: the deductibility of federal NOLs generated in tax years beginning before December 31, 2017 in the amount of $ 5,652
+Added: Under the Tax Act, federal NOLs incurred in taxable years ending after December 31, 2017 in the amount of
+Added: may be carried forward indefinitely and are subject to an 80% usage limitation.
+Added: The deductibility of federal NOLs generated in
+Added: tax years beginning before December 31, 2017 in the amount of $ 5,652
will expire in 2037.
−Removed: The state NOL carry forward
−Removed: will begin to expire in 2029.
+Added: The state NOL carry forward will begin to expire
addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if
18 unchanged sentences
Company has entered into various agreements in addition to those discussed above which are described below.
−Removed: Company acquired the exclusive rights to sell the Cysteine injection product in the United States pursuant to a sales and marketing agreement
−Removed: dated November 17, 2017 with an unaffiliated third party (the “Sales Agreement”).
−Removed: Pursuant to the Sales Agreement, the licensor
−Removed: is responsible for obtaining FDA approval, at its expense, and the Company is responsible for commercializing the product in the United
−Removed: States at its expense.
−Removed: The Company was to pay the third party 50 % of the net profit from the sale of the product, however, in February
−Removed: 2020, it executed an amendment to the Sales and Marketing Agreement.
−Removed: Under the revised terms, the Company will be responsible for paragraph
−Removed: IV related litigation and will be entitled to 62.5 % of product profit.
−Removed: The initial term is for the first 10 years following the first
−Removed: commercial sale of the product.
−Removed: February 8, 2019, the Company entered into an Exclusive Licensing and Supply Agreement (the “ET-202 License Agreement”) with
−Removed: Sintetica SA (“Sintetica”) for marketing rights in the United States to Biorphen® which is used for the treatment of
−Removed: clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
−Removed: The product was submitted to the
−Removed: FDA for review and subsequently received FDA approval on October 21, 2019.
−Removed: Pursuant to the terms of the ET-202 License Agreement, the
−Removed: Company is responsible for marketing activities and Sintetica is responsible for development, manufacturing, and the regulatory activities
−Removed: related to approval.
−Removed: The Company paid Sintetica a licensing payment of $ 2,000 upon execution of the ET-202 License Agreement and $ 750
−Removed: upon the commencement of commercial product shipments.
−Removed: Sintetica supplies Biorphen to the Company at its direct costs and the Company
−Removed: retains 5 % of net sales as a marketing fee.
−Removed: Sintetica is entitled to receive the first $ 500 of product profits.
−Removed: All additional profit
−Removed: will be split 50 % to the Company and 50 % to Sintetica.
−Removed: The ET-202 License Agreement has a ten-year term from the first commercial sale
−Removed: of Biorphen which occurred in November 2019.
−Removed: There was a gross loss for Biorphen for the years ended December 31, 2021 and 2020 due to
−Removed: slower than anticipated sales and a product price reduction through the Company’s wholesale customers.
−Removed: February 8, 2019, the Company also entered into an Exclusive Licensing and Supply Agreement (the “ET-203 License Agreement”)
−Removed: with Sintetica for marketing rights in the United States to ephedrine HCl (brand name Rezipres®), an injectable product candidate
−Removed: for use in the hospital setting.
−Removed: Pursuant to the terms of the ET-203 License Agreement, the Company will be responsible for marketing
−Removed: activities and Sintetica will be responsible for development, manufacturing, and regulatory activities related to obtaining regulatory
−Removed: The Company paid Sintetica a licensing payment of $ 1,000 upon execution of the ET-203 License Agreement which was refunded
−Removed: to Eton in early 2020 due to the FDA not accepting the ET-203 file submission by Sintetica.
−Removed: The Rezipres product was successfully resubmitted
−Removed: in late 2020 and the Company paid a $ 600 milestone fee in July 2021 and will pay $ 750 upon the commercial sale of the product.
−Removed: supplies Rezipres to the Company at its direct costs.
−Removed: The Company will retain 5 % of net sales as a marketing fee.
−Removed: Sintetica will be entitled
−Removed: to receive the first $ 500 of product profits.
−Removed: All additional profit will be split 50 % to the Company and 50 % to Sintetica.
−Removed: License Agreement has a ten-year term from first commercial sale of product.
−Removed: Pharmaceuticals, Inc.
−Removed: TO FINANCIAL STATEMENTS
−Removed: thousands, except share and per share amounts)
−Removed: 14 — Commitments and Contingencies (continued)
three oral solution pediatric neurology product candidates discussed below, Topiramate, Zonisamide and Lamotrigine were developed by
1 unchanged sentence
these three products to Azurity in 2021.
−Removed: The Company has recognized $ 17,000 in milestone
−Removed: revenues to date from these three products and may receive up to $ 25,000 in additional milestone revenues related to FDA product approvals
−Removed: and the future sales levels for the products.
+Added: The Company has recognized $ 22,000
+Added: in milestone revenues to date from these three products (including $ 5,000 received in 2022) and may receive up to $ 20,000
+Added: in additional milestone revenues related to FDA product approvals and the future sales levels for the products.
+Added: Azurity has assumed
+Added: royalty or profit share obligations owed to development partners as well as additional milestone payments based on sales volume
the years ended December 31, 2021 and 2020 the Company worked with Tulex Pharmaceuticals, Inc.
−Removed: (“Tulex”) as a third-party
−Removed: contract manufacturer to develop an oral solution for Topiramate (fka ET-101) which targets a neurological condition.
−Removed: The Company subsequently
−Removed: filed the product with the FDA in October 2020 and paid a $ 1,438 filing fee.
−Removed: In November 2021, the product received approval from the
−Removed: FDA and was launched by Azurity in December 2021.
−Removed: The Company recognized a $ 5,000 milestone revenue at launch which was reflected in
−Removed: accounts receivable on the Company’s balance sheet at December 31, 2021 and subsequently collected in January 2022.
−Removed: January 23, 2019, the Company entered into a Licensing and Supply Agreement (the “Agreement”) with LMW for Zonisamide oral
−Removed: liquid, a development stage product candidate (“ET-104”).
−Removed: Pursuant to the terms of the Agreement, the Company was to be responsible
−Removed: for regulatory and marketing activities.
−Removed: LMW will be responsible for development and manufacturing of ET-104.
−Removed: The Company paid the licensor
−Removed: $ 350 upon execution of the Agreement and an additional $ 350 after receiving successful bioequivalence study results, and $ 325 upon the
−Removed: FDA’s acceptance of the NDA for review and will pay $ 325 upon FDA approval of the NDA, $ 650 upon issuance of patent covering ET-104
−Removed: listed in the FDA’s Orange Book and $ 500 in the event that product sales in excess of $ 10,000 were achieved within a calendar year.
−Removed: In addition, the Company was required to pay the licensor 35 % of the net profit from product sales.
−Removed: The Agreement was for an initial
−Removed: term of 10 years from the date of the first commercial sale of the product.
−Removed: The Company was to retain sole ownership of the NDA after
−Removed: expiration of the Agreement.
−Removed: June 12, 2019, the Company entered into an Exclusive Licensing and Supply Agreement (the “ET-105 License Agreement”) with
−Removed: Aucta Pharmaceuticals, Inc.
−Removed: (“Aucta”) for marketing rights in the United States to Lamotrigine, an oral suspension product
−Removed: candidate for use as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of
−Removed: Lennox-Gastaut syndrome in patients two years of age and older.
−Removed: Pursuant to the terms of the ET-105 License Agreement, the Company was
−Removed: to be responsible for marketing activities and Aucta will be responsible for development, manufacturing, and regulatory activities related
−Removed: to obtaining regulatory approval.
−Removed: The Company paid Aucta a licensing payment of $ 2,000
−Removed: in August 2019 upon receiving an acceptance for
−Removed: review letter from the FDA and will pay $ 2,450
−Removed: upon FDA approval and commercial sales of the
−Removed: product candidate and another $ 1,000
−Removed: upon issuance of an Orange-book listed patent.
−Removed: If Aucta successfully completes a Lamotrigine product line extension product, Eton will pay $ 1,500
−Removed: upon FDA acceptance of the product filing,
−Removed: upon FDA approval and commercial sales of the
−Removed: extension product candidate and $ 450 if the intellectual property for the extension product is transferred to Azurity.
−Removed: Aucta will be entitled to receive milestone payments from the Company of up to $ 3,000
−Removed: based on commercial success of the product, including:
+Added: (“Tulex”) as a
+Added: third-party contract manufacturer to develop an oral solution for Topiramate (fka ET-101) which targets a neurological condition.
+Added: The Company subsequently filed the product with the FDA in October 2020 and paid a $ 1,438
+Added: In November 2021, the product received approval from the FDA and was launched by Azurity in December 2021.
+Added: recognized a $ 5,000
+Added: milestone revenue at launch which was reflected in accounts receivable on the Company’s balance sheet at December 31, 2021 and
+Added: subsequently collected in January 2022.
+Added: January 23, 2019, the Company entered into a Licensing and Supply Agreement (the “Agreement”) with Liquimeds Worldwide (“LMW”)
+Added: for Zonisamide oral liquid, a development stage product candidate (“ET-104”).
+Added: Pursuant to the terms of the Agreement, the
+Added: Company was to be responsible for regulatory and marketing activities and LMW was responsible for development and manufacturing of ET-104.
+Added: The Company paid $ 650
+Added: to Azurity upon issuance of patent covering ET-104
+Added: listed in the FDA’s Orange Book in November 2022 and will pay $ 500
+Added: in the event that product sales in excess of
+Added: were achieved within a calendar year.
+Added: June 12, 2019, the Company entered into an Exclusive Licensing and Supply Agreement (the “ET-105 License Agreement”)
+Added: with Aucta Pharmaceuticals, Inc.
+Added: (“Aucta”) for marketing rights in the United States to Lamotrigine, an oral suspension
+Added: product candidate for use as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized
+Added: seizures of Lennox-Gastaut syndrome in patients two years of age and older.
+Added: Pursuant to the terms of the ET-105 License Agreement,
+Added: the Company was to be responsible for marketing activities and Aucta will be responsible for development, manufacturing, and
+Added: regulatory activities related to obtaining regulatory approval.
+Added: The Company paid Aucta a licensing payment of $ 2,000 in
+Added: August 2019 upon receiving an acceptance for review letter from the FDA and will pay $ 2,450 upon
+Added: FDA approval and commercial sales of the product candidate and another $ 1,000 upon
+Added: issuance of an Orange-book listed patent.
+Added: If Aucta successfully completes a Lamotrigine product line extension product, Eton will
+Added: pay $ 1,500 upon
+Added: FDA acceptance of the product filing.
+Added: Aucta will be entitled to receive milestone payments from the Company of up to $ 3,000 based
+Added: on commercial success of the product, including $ 1,000
when net sales exceed $10 million in a calendar year ,
when net sales exceed $20 million in a calendar year .
−Removed: Azurity will assume royalty
−Removed: or profit share obligations owed to development partners as well as additional milestone payments based on sales volume targets.
Pharmaceuticals, Inc.
2 unchanged sentences
14 — Commitments and Contingencies (continued)
+Added: will assume royalty or profit share obligations owed to development partners as well as additional milestone payments based on sales
+Added: volume targets.
March 27, 2020, the Company entered into an Exclusive Licensing and Supply Agreement (the “Alkindi License Agreement”) with
Diurnal for marketing ALKINDI SPRINKLE® in the United States.
−Removed: Alkindi Sprinkle’s New Drug Application (NDA) was approved by the
−Removed: FDA on September 29, 2020 as a replacement therapy for pediatric adrenal insufficiency (AI), including congenital adrenal hyperplasia
−Removed: (CAH) in patients from birth to less than 17 years of age.
+Added: ALKINDI SPRINKLE®’s New Drug Application (NDA) was approved
+Added: by the FDA on September 29, 2020 as a replacement therapy for pediatric patients with adrenocortical insufficiency.
the initial licensing milestone fee, the Company paid Diurnal $ 3,500 in cash and issued 379,474 shares of its common stock to Diurnal
7 unchanged sentences
which is under development as a rescue treatment for adrenal crisis.
−Removed: The Company expects to submit the New Drug Application (NDA) to
−Removed: the FDA in 2023 and plans to request orphan drug designation.
−Removed: The Company paid Crossject $ 500 upon signing and could pay up to $ 4,500
−Removed: in development milestones and up to $ 6,000 in commercial milestones, as well as a 10 % royalty on net sales.
+Added: The Company paid Crossject $ 500 upon signing, $ 500 in March 2022
+Added: upon a completion of a successful technical batch and could pay up to $ 3,500 in additional development milestones and up to $ 6,000 in
+Added: commercial milestones, as well as a 10 % royalty on net sales.
October 28, 2021, the Company acquired the U.S.
4 unchanged sentences
substitutable generic version of Carbaglu®.
−Removed: The Company paid $ 3,250 upon signing and will retain 50 % of future product profits with
−Removed: the balance being distributed to the licensor and manufacturer.
+Added: The Company paid $ 3,250
+Added: upon signing and retains 50 %
+Added: of the product profits with the balance being distributed to the licensor and manufacturer.
+Added: The Company launched this product in December
+Added: In June 2022, the Company sold
+Added: its rights in Cysteine Hydrochloride, Biorphen®, and Rezipres® to Dr.
+Added: Under the terms of the transaction, Dr.
+Added: Reddy’s assumed immediate ownership of Eton’s rights and interest in the products.
+Added: The Company received $ 5,000 at closing,
+Added: recorded as licensing revenue in the twelve months ended December 31, 2022, and could receive up to $ 42,500 of additional payments based
+Added: on the achievement of certain event-based and sales-based milestones.
+Added: Of the $ 5,000 received at closing, $ 250 was held in escrow to address
+Added: potential indemnity claims during the 12-month period following the effective date of the agreement.
+Added: In addition, 10 % of any additional
+Added: payments paid by Dr.
+Added: Reddy’s during the 12-month period following the effective date will be held in escrow and subsequently released
+Added: to Eton upon expiration of the 12-month period following the effective date.
+Added: In accordance with the terms of the agreement, $ 812 of Sintetica
+Added: profit share receivables were expensed as cost of goods sold in the twelve months ended December 31, 2022.
+Added: September 13, 2022, the Company acquired an FDA-approved ANDA for Betaine Anhydrous for oral solution.
+Added: The ANDA was approved by the FDA
+Added: on January 28, 2022.
+Added: The Company paid $ 2,000 upon signing and could pay up to $ 1,000 in commercial milestones.
+Added: The Company will retain
+Added: 65 % of the product profits with the balance being distributed to the licensor.
Indemnification
9 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.