1 unchanged sentence
Evaluation of disclosure controls and procedures
−Removed: Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in the Securities Exchange Act of 1934 Rules 13a-15(e) or 15d-15(e)) as of the end of the period covered by this 2021 10-K Report.
−Removed: Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2021, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is (i) recorded, processed, summarized, and reported within the time periods specified in the SEC rules and forms, and (ii) is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
+Added: Our management evaluated the effectiveness of our disclosure controls and procedures (as defined in the Securities Exchange Act of 1934 Rules 13a-15(e) or 15d-15(e)) as of the end of the period covered by this 2022 10-K Report.
+Added: Based on that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that, as of December 31, 2022, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is (i) recorded, processed, summarized, and reported within the time periods specified in the SEC rules and forms, and (ii) is accumulated and communicated to our management, including our Principal Executive Officer and Principal Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
Changes in internal control over financial reporting
1 unchanged sentence
Inherent limitations on effectiveness of controls
−Removed: Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud.
+Added: Our management does not expect that our disclosure controls and procedures or our internal controls will prevent all error and all fraud.
A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
16 unchanged sentences
Other information
−Removed: 2022 executive retention and performance bonus plan
−Removed: On March 23, 2022, the Company entered into award agreements (the "Award Agreements") with each of Mr.
−Removed: Walker, the General Counsel of the Company, and Mr.
−Removed: Donegan, the Vice President – Finance and Chief Accounting Officer of the Company who will become Interim Chief Financial Officer of the Company, under the Company’s 2022 Executive Retention and Performance Bonus Plan (the “ERB Plan”).
−Removed: Under the terms of the Award Agreements and the ERB Plan, each of Mr.
−Removed: Walker and Mr.
−Removed: Donegan was granted (i) a retention award of $207,500 and $87,000, respectively (each a “Retention Payment”), and (ii) a performance bonus award of $622,500 and $261,000, respectively (each a “Bonus Target”), based on the achievement of critical strategic, tactical and financial goals of the Company (each a “Performance Bonus Award”).
−Removed: If the employment of a participant under the ERB Plan is terminated by the Company for “cause” or by the participant other than for “good reason” (i) on or before July 1, 2022, the participant will be required to pay back 100% of the after-tax value of the Retention Payment, or (ii) after July 1, 2022, the participant will be required to pay back 50% of the after-tax value of the Retention Payment.
−Removed: The Performance Bonus Awards will be based on Company performance for four separate six-month performance periods from January 1, 2022 to December 31, 2023 based on performance targets approved by the Compensation Committee of the Board of Directors of the Company and will be payable at up to 150% of the Bonus Target.
−Removed: The foregoing description of the ERB Plan does not purport to be complete and is qualified in its entirety by reference to the full text of the ERB Plan, which is attached hereto as Exhibit 10.55 and is incorporated herein by reference.
Disclosure regarding foreign jurisdictions that prevent inspections
27 unchanged sentences
First Amendment to Bylaws of the Company, dated December 17, 2015 (8)
+Added: Second Amendment to Bylaws of the Company, adopted May 27, 2022 (36)
+Added: Third Amendment to Bylaws of the Company, dated July 29, 2022 (37)
+Added: Certificate of Change to Articles of Incorporation of the Company ( 38)
+Added: Certificate of Designation, Preferences and Rights of Series A Preferred Stock (37)
Form of Certificate of Common Stock ( 9)
Description of Securities of the Company
−Removed: Form of Common Stock Purchase Warrant, dated ( 11)
+Added: Form of Common Stock Purchase Warrant ( 11)
Form of Non-Qualified Stock Option Agreement ( 11)
7 unchanged sentences
2020 Employee Stock Purchase Plan ( 15)
−Removed: Common Stock Purchase Warrant to Lang Naturals, Inc., dated October 23, 2011 (16)
Form of Common Stock Purchase Warrant, dated February 24, 2012 (17)
9 unchanged sentences
Milligan, IV ( 20)
−Removed: Financing Agreement, dated April 24, 2019, by and among TherapeuticsMD, Inc.
−Removed: as the Borrower, vitaMedMD, LLC, BocaGreenMD, Inc.
−Removed: and vitaCare Prescription Services, Inc.
−Removed: as the Guarantors, TPG Specialty Lending, Inc., Top IV Talents, LLC and Tao Talents, LLC as the Lenders (21)
−Removed: Amendment No.
−Removed: 1 to the Financing Agreement, dated December 27, 2019, by and among TherapeuticsMD, Inc.
−Removed: as the Borrower, vitaMedMD, LLC, BocaGreenMD, Inc.
−Removed: and vitaCare Prescription Services, Inc.
−Removed: as the Guarantors, TPG Specialty Lending, Inc., Top IV Talents, LLC and Tao Talents, LLC as the Lenders (11)
−Removed: Amendment No.
−Removed: 2 to the Financing Agreement, dated April 17, 2020, by and among TherapeuticsMD, Inc.
−Removed: as the Borrower, vitaMedMD, LLC, BocaGreenMD, Inc.
−Removed: and vitaCare Prescription Services, Inc.
−Removed: as the Guarantors, TPG Specialty Lending, Inc., Top IV Talents, LLC and Tao Talents, LLC as the Lenders (6)
−Removed: Amendment No.
−Removed: 3 to the Financing Agreement, dated May 1, 2020, by and among TherapeuticsMD, Inc.
−Removed: as the Borrower, vitaMedMD, LLC, BocaGreenMD, Inc.
−Removed: and vitaCare Prescription Services, Inc.
−Removed: as the Guarantors, TPG Specialty Lending, Inc., Top IV Talents, LLC and Tao Talents, LLC as the Lenders (6 )
−Removed: Amendment No.
−Removed: 4 to the Financing Agreement, dated May 13, 2020, by and among TherapeuticsMD, Inc.
−Removed: as the Borrower, vitaMedMD, LLC, BocaGreenMD, Inc.
−Removed: and vitaCare Prescription Services, Inc.
−Removed: as the Guarantors, TPG Specialty Lending, Inc., Top IV Talents, LLC and Tao Talents, LLC as the Lenders (6)
−Removed: Amendment No.
−Removed: 5 to the Financing Agreement, dated August 5, 2020, by and among TherapeuticsMD, Inc.
−Removed: as the Borrower, vitaMedMD, LLC, BocaGreenMD, Inc.
−Removed: and vitaCare Prescription Services, Inc.
−Removed: as the Guarantors, TPG Specialty Lending, Inc., Top IV Talents, LLC and Tao Talents, LLC as the Lenders (6)
−Removed: Amendment No.
−Removed: 6 to the Financing Agreement, dated November 8, 2020, by and among TherapeuticsMD, Inc.
−Removed: as the Borrower, vitaMedMD, LLC, BocaGreenMD, Inc.
−Removed: and vitaCare Prescription Services, Inc.
−Removed: as the Guarantors, TPG Specialty Lending, Inc., Top IV Talents, LLC and Tao Talents, LLC as the Lenders (19)
−Removed: Amendment No.
−Removed: 7 to the Financing Agreement, dated January 13, 2021, by and among TherapeuticsMD, Inc.
−Removed: as the Borrower, vitaMedMD, LLC, BocaGreenMD, Inc.
−Removed: and vitaCare Prescription Services, Inc.
−Removed: as the Guarantors, TPG Specialty Lending, Inc., Top IV Talents, LLC and Tao Talents, LLC as the Lenders (2 0)
−Removed: Amendment No.
−Removed: 8 to the Financing Agreement, dated March 1, 2021, by and among TherapeuticsMD, Inc.
−Removed: as the Borrower, vitaMedMD, LLC, BocaGreenMD, Inc.
−Removed: and vitaCare Prescription Services, Inc.
−Removed: as the Guarantors, TPG Specialty Lending, Inc., Top IV Talents, LLC and Tao Talents, LLC as the Lenders (20)
−Removed: Amendment No.
−Removed: 9 to the Financing Agreement, dated March 8, 2022, by and among TherapeuticsMD, Inc.
−Removed: as the Borrower, vitaMedMD, LLC, BocaGreenMD, Inc.
−Removed: and vitaCare Prescription Services, Inc.
−Removed: as the Guarantors, TPG Specialty Lending, Inc., Top IV Talents, LLC and Tao Talents, LLC as the Lenders (37)
−Removed: Pledge and Security Agreement, dated April 24, 2019, by and among TherapeuticsMD, Inc.
−Removed: as the Borrower, vitaMedMD, LLC, BocaGreenMD, Inc.
−Removed: and vitaCare Prescription Services, Inc.
−Removed: as the Guarantors, TPG Specialty Lending, Inc., Top IV Talents, LLC and Tao Talents, LLC as the Lenders (21)
Subscription Agreement, dated August 5, 2020, by and among TherapeuticsMD, Inc.
and the Subscribers identified on the Schedule of Subscribers attached thereto ( 6)
−Removed: Commercial Supply Agreement, dated September 28, 2018, by and between TherapeuticsMD, Inc.
−Removed: and QPharma AB (22)
−Removed: Softgel Commercial Supply Agreement, dated April 20, 2016, by and between TherapeuticsMD, Inc.
−Removed: and Catalent Pharma Solutions, LLC (23)
−Removed: Amendment No.
−Removed: 2 to the Commercial Supply Agreement, dated September 29, 2020, between TherapeuticsMD, Inc.
−Removed: and Catalent Pharma Solutions, LLC (19)
−Removed: Softgel Commercial Supply Agreement, dated June 24, 2016, by and between TherapeuticsMD, Inc.
−Removed: and Catalent Pharma Solutions, LLC (24)
−Removed: Amendment No.1 to Softgel Commercial Supply Agreement, dated December 1, 2017, by and between TherapeuticsMD, Inc.
−Removed: and Catalent Pharma Solutions, LLC (19)
−Removed: Amendment No.2 to Softgel Commercial Supply Agreement, dated September 29, 2020, by and between TherapeuticsMD, Inc.
−Removed: and Catalent Pharma Solutions, LLC (19)
License Agreement, dated July 30, 2018, by and between TherapeuticsMD, Inc.
and The Population Council, Inc.
−Removed: Agreement to Forfeit Non-Qualified Stock Options, dated May 8, 2013, between the Company and Robert G.
Lease, dated October 5, 2018, by and between 951 Yamato Acquisition Company, LLC and TherapeuticsMD, Inc.
5 unchanged sentences
Employment Agreement, dated June 1, 2020, between the Company and James C.
+Added: D’Arecca ( 6)
Amendment to Employment Agreement, dated October 15, 2021, between TherapeuticsMD, Inc.
7 unchanged sentences
Amended and Restated Employment Agreement, dated November 24, 2020, between the Company and Robert G.
+Added: Finizio ( 2 4 )
Amended and Restated Employment Agreement, dated November 24, 2020, between the Company and John C.K.
13 unchanged sentences
and Cantor Fitzgerald & Co.
−Removed: Controlled Equity Offering SM Sales Agreement, dated March 3, 2021, by and between TherapeuticsMD, Inc.
+Added: Controlled Equity OfferingSM Sales Agreement, dated March 3, 2021, by and between TherapeuticsMD, Inc.
and Cantor Fitzgerald & Co.
2022 Executive Retention and Performance Bonus Plan.
+Added: (ERB-Plan) ( 34)
+Added: Subscription Agreement between TherapeuticsMD, Inc.
+Added: and Rubric Capital Management LP, dated July 29, 2022 (37)
+Added: S u bscription Agreement by and among TherapeuticsMD, Inc., Sixth Street Specialty Lending, Inc., TOP IV Talents, LLC and TOA Talents, LLC, dated July 29, 2022 (37)
+Added: Subscription Agreement between TherapeuticsMD, Inc.
+Added: and Rubric Capital Management LP, dated September 30, 2022 (39)
+Added: Subscription Agreement by and among TherapeuticsMD, Inc., Sixth Street Specialty Lending, Inc., TOP IV Talents, LLC and TAO Talents, LLC, dated September 30, 2022 (39)
+Added: Subscription Agreement between TherapeuticsMD, Inc.
+Added: and Rubric Capital Management LP, dated October 28, 2022 (40)
+Added: Subscription Agreement by and among TherapeuticsMD, Inc., Sixth Street Specialty Lending, Inc., TOP IV Talents, LLC and TAO Talents, LLC, dated October 28, 2022 (40)
+Added: License Agreement by and between TherapeuticsMD, Inc.
+Added: and Mayne Pharma LLC, dated December 4, 2022 (41)
+Added: Transaction Agreement by and between TherapeuticsMD, Inc.
+Added: and Mayne Pharma LLC, dated December 4, 2022 (41)
+Added: Amendment No.
+Added: 1 to the License Agreement between TherapeuticsMD, Inc.
+Added: and Mayne Pharma LLC, dated as of December 30, 2022
+Added: Amendment No.
+Added: 1 to the Transaction Agreement between TherapeuticsMD, Inc.
+Added: and Mayne Pharma LLC, dated as of December 30, 2022
+Added: Amended and Restated Employment Agreement, dated as of December 18, 2018, by and between TherapeuticsMD, Inc.
+Added: and Marlan Walker
+Added: Amendment, effective October 15, 2021, to the Employment Agreement, dated as of December 18, 2018, by and between TherapeuticsMD, Inc.
+Added: and Marlan Walker
+Added: Amendment, dated February 21, 2023, to the Employment Agreement, dated as of December 18, 2018, as extended effective October 15, 2021, by and between TherapeuticsMD, Inc.
+Added: and Marlan Walker ( 16)
+Added: General Consulting and Services Agreement by and between TherapeuticsMD, Inc.
+Added: and MCD Consulting Management Services, LLC, dated February 21, 2023 (16)
Subsidiaries of the Company
30 unchanged sentences
Filed as an appendix to the Definitive Proxy Statement filed with the Commission on May 4, 2020 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 8-K filed with the Commission on October 24, 2011 and incorporated herein by reference (SEC File No.
Filed as an exhibit to Form 8-K filed with the Commission on February 27, 2023 and incorporated herein by reference (SEC File No.
Filed as an exhibit to Form 8-K filed with the Commission on February 24, 2012 and incorporated herein by reference (SEC File No.
+Added: Filed as an exhibit to Form 8-K filed with the Commission on February 6, 2013 and incorporated herein by reference (SEC File No.
Filed as an exhibit to Form 10-Q filed with the Commission on November 9, 2020 and incorporated herein by reference (SEC File No.
2 unchanged sentences
Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2018 filed with the Commission on November 8, 2018 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 10-Q for the quarter ended June 30, 2018 filed with the Commission on July 30, 2018 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 10-K for the year ended December 31, 2018 filed with the Commission on February 27, 2019 and incorporated herein by reference (SEC File No.
Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2019 filed with the Commission on November 8, 2019 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2013 filed with the Commission on May 10, 2013 and incorporated herein by reference (SEC File No.
−Removed: Filed as an exhibit to Form 10-Q for the quarter ended September 30, 2019 filed with the Commission on November 8, 2019 and incorporated herein by reference (SEC File No.
Filed as an exhibit to Form 8-K filed with the Commission on November 27, 2020 and incorporated herein by reference (SEC File No.
8 unchanged sentences
Filed as an exhibit to Form 8-K filed with the Commission on March 10, 2022 and incorporated herein by reference (File No.
+Added: Filed as an exhibit to Form 10-K for the year ended December 31, 2021, filed with the Commission on March 23, 2022 and incorporated herein by reference (File No.
+Added: Filed as an exhibit to Form 10-Q for the quarter ended March 31, 2022, filed with the Commission on May 16, 2022 and incorporated herein by reference (File No.
+Added: Filed as an exhibit to Form 8-K filed with the Commission on June 3, 2022 and incorporated herein by reference (File No.
+Added: Filed as an exhibit to Form 8-K filed with the Commission on August 1, 2022 and incorporated herein by reference (File No.
+Added: Filed as an exhibit to Form 8-K filed with the Commission on May 9, 2022 and incorporated herein by reference (File No.
+Added: Filed as an exhibit to Form 8-K filed with the Commission on October 3, 2022 and incorporated herein by reference (File No.
+Added: Filed as an exhibit to Form 8-K filed with the Commission on October 31, 2022 and incorporated herein by reference (File No.
+Added: Filed as an exhibit to Form 8-K filed with the Commission on December 5, 2022 and incorporated herein by reference (File No.
Form 10-K summary
−Removed: Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this 2021 10-K Report to be signed on its behalf by the undersigned, thereunto duly authorized, on March 23, 2022
+Added: Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this 2022 10-K Report to be signed on its behalf by the undersigned, thereunto duly authorized, on April 7, 2023
THERAPEUTICSMD, INC.
−Removed: /s/ Hugh O’Dowd
+Added: /s/ Marlan D.
Chief Executive Officer
−Removed: Chief Financial Officer
−Removed: Pursuant to the requirements of the Securities Exchange Act of 1934, this 2021 10-K Report has been signed below by the following persons on behalf of the registrant and in the capacities and on the date indicated on March 23, 2022.
−Removed: /s/ Hugh O’Dowd
−Removed: Chief Executive Officer and Director
+Added: /s/ Michael C.
+Added: Principal Financial and Accounting Officer
+Added: Pursuant to the requirements of the Securities Exchange Act of 1934, this 2022 10-K Report has been signed below by the following persons on behalf of the registrant and in the capacities and on the date indicated on April 7, 2023.
+Added: /s/ Marlan D.
+Added: Chief Executive Officer
(Principal Executive Officer)
−Removed: Chief Financial Officer
−Removed: (Principal Financial Officer)
/s/ Michael C.
−Removed: Chief Accounting Officer
−Removed: (Principal Accounting Officer)
+Added: Principal Financial and Accounting Officer
/s/ Cooper C.
1 unchanged sentence
Naughton, Ph.D.
+Added: /s/ Justin Roberts
+Added: Justin Roberts
INDEX TO FINANCIAL STATEMENTS
2 unchanged sentences
Consolidated Statements of Operations
−Removed: Consolidated Statements of Stockholders’ Deficit
+Added: Consolidated Statements of Stockholders’ E quity ( Deficit)
Consolidated Statements of Cash Flows
5 unchanged sentences
We have audited the accompanying consolidated balance sheets of TherapeuticsMD, Inc.
−Removed: (a Nevada corporation) and subsidiaries (the “Company”) as of December 31, 2021 and 2020, the related consolidated statements of operations, stockholders’ deficit, and cash flows for each of the three years in the period ended December 31, 2021, and the related notes (collectively referred to as the “financial statements”).
−Removed: In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2021, in conformity with accounting principles generally accepted in the United States of America.
+Added: (a Nevada corporation) and subsidiaries (the “Company”) as of December 31, 2022 and 2021, the related consolidated statements of operations, stockholders’ equity (deficit), and cash flows for each of the two years in the period ended December 31, 2022, and the related notes collectively referred to as the “financial statements”).
+Added: In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.
Going concern
−Removed: The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.
−Removed: As discussed in Note 1 to the financial statements, the Company incurred a net loss of $172.4 million during the year ended December 31, 2021, and as of that date, the Company’s current liabilities exceeded its current assets by $133.4 million and its total liabilities exceeded its total assets by $93.6 million.
+Added: The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern.
+Added: As discussed in Note 1 to the financial statements, the Company has recently changed its business strategy to become a royalty company.
+Added: The Company has limited experience operating as a royalty company and may need to raise additional capital to fund its operations until the Company becomes cash flow positive.
These conditions, along with other matters as set forth in Note 1, raise substantial doubt about the Company’s ability to continue as a going concern.
15 unchanged sentences
We believe that our audits provide a reasonable basis for our opinion.
−Removed: Critical audit matters
−Removed: The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
+Added: Critical audit matter
+Added: Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
(1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
−Removed: The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
−Removed: Calculation of variable consideration related to rebates
−Removed: As described further in Note 1 to the financial statements, the transaction price of the Company’s prescription products is variable as it is calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees.
−Removed: We identified the calculation of variable consideration related to rebates as a critical audit matter.
−Removed: The principal consideration for our determination that the calculation of variable consideration related to rebates was a critical audit matter is that auditing the estimation of variable consideration for rebates requires significant judgement and the amounts are material to the financial statements taken as a whole.
−Removed: These estimates require the consideration of the estimated level of inventory in the distribution channel, average rebate percentage, and expected insurance adjudication rate, all of which are key assumptions and have estimation uncertainty.
−Removed: Our audit procedures related to testing the calculation of variable consideration related to rebates included the following, among others:
−Removed: We evaluated the design and tested the operating effectiveness of controls over management’s calculation and review of variable consideration related to rebates by verifying management’s controls over the completeness of the input data, mathematical accuracy of the calculations and evaluating the reasonableness of the estimated level of inventory in the distribution channel, average rebate percentage, and expected insurance adjudication rate.
−Removed: We tested management’s rebate estimates by reviewing subsequent events or transactions.
−Removed: Our procedures included reviewing subsequent information related to rebate settlements.
−Removed: We also evaluated the average rebates by vouching a sample of transactions settled during the year to source documentation, agreeing rebate percentages to underlying contracts, and we performed a sensitivity analysis that considered the estimated level of inventory in the distribution channel, average rebate percentage and expected adjudication rate.
+Added: We determined that there are no critical audit matters.
/s/ GRANT THORNTON LLP
1 unchanged sentence
Miami, Florida
−Removed: March 23, 2022
+Added: April 7, 2023
TherapeuticsMD, Inc.
4 unchanged sentences
Current assets:
−Removed: Accounts receivable, net of allowance for credit losses of $ 1,334 and $ 1,118 as of
−Removed: December 31, 2021 and 2020, respectively
+Added: Restricted cash
Prepaid and other current assets
+Added: Current assets of discontinued operations
Total current assets
2 unchanged sentences
Right of use assets
+Added: Royalty receivable, long term
Other non-current assets
−Removed: Liabilities and stockholders' deficit:
+Added: Non-current assets of discontinued operations
+Added: Liabilities and stockholders' equity (deficit):
Current liabilities:
2 unchanged sentences
Accrued expenses and other current liabilities
+Added: Current liabilities of discontinued operations
Total current liabilities
−Removed: Long-term debt, net
Operating lease liabilities, non-current
2 unchanged sentences
Commitments and contingencies (Note 8)
−Removed: Stockholders' deficit:
+Added: Stockholders' equity (deficit):
Preferred stock, par value $ 0.001 ;
−Removed: 10,000 shares authorized, none issued
+Added: 10,000 shares authorized
Common stock, par value $ 0.001 ;
12,000 shares authorized, 9,498 and 8,598
−Removed: issued and outstanding as of December 31, 2021 and 2020, respectively
+Added: (adjusted for the 50-for-1 reverse stock split ) issued and outstanding as of December 31, 2022 and 2021, respectively
Additional paid-in capital
Accumulated deficit
−Removed: Total stockholders' deficit
−Removed: Total liabilities and stockholders' deficit
+Added: Total stockholders' equity (deficit)
+Added: Total liabilities and stockholders' equity (deficit)
The accompanying notes are an integral part of these consolidated financial statements.
7 unchanged sentences
Total revenue, net
−Removed: Cost of goods sold
+Added: Cost of revenue
Operating expenses:
2 unchanged sentences
Research and development
+Added: Restructuring expense
Total operating expenses
−Removed: Loss from operations
+Added: Income (loss) from operations
Other (expense) income:
−Removed: Loss on extinguishment of debt
−Removed: Interest expense and other financing costs
−Removed: Other income, net
−Removed: Total other expense, net
−Removed: Loss before income taxes
+Added: Other (expense) income, net
+Added: Total other (expense) income, net
+Added: Income (loss) from continuing operations before income taxes
Provision for income taxes
−Removed: Loss per common share, basic and diluted
−Removed: Weighted average common shares, basic and diluted
−Removed: Comprehensive loss:
+Added: Net income (loss) from continuing operations
+Added: Income (loss) from discontinued operations, net of income taxes
+Added: Net income (loss)
+Added: Income (loss) per common share, basic:
+Added: Continuing operations
+Added: Discontinued operations, net
+Added: Net income (loss)
+Added: Income (loss) per common share, diluted:
+Added: Continuing operations
+Added: Discontinued operations, net
+Added: Net income (loss)
+Added: Weighted average common shares, basic
+Added: Weighted average common shares, diluted
+Added: Comprehensive income (loss):
+Added: Net income (loss)
Other comprehensive income
−Removed: Comprehensive loss
+Added: Comprehensive income (loss)
The accompanying notes are an integral part of these consolidated financial statements.
1 unchanged sentence
and Subsidiaries
−Removed: Consolidated Statements of Stockholders' Deficit
+Added: Consolidated Statements of Stockholders' (Deficit) Equity
(In thousands)
−Removed: Balance, January 1, 2019
−Removed: Shares issued for sale of common stock, net of cost
−Removed: Shares issued for exercise of warrants, net of cashless
−Removed: Shares issued for exercise of options
−Removed: Share-based payment award compensation costs
Balance, December 31, 2020
Shares issued for sale of common stock, net of cost
+Added: Shares issued for exercise of warrants, net of cashless
Shares issued for exercise of options
Shares issued for vested restricted and performance stock units
−Removed: Warrants issued in relation to debt financing agreement
+Added: Shares issued for sale of common stock related to employee stock purchase plan
Share-based payment award compensation costs
1 unchanged sentence
Shares issued for sale of common stock, net of cost
−Removed: Shares issued for exercise of warrants, net of cashless
−Removed: Shares issued for exercise of options
+Added: Lender warrants
+Added: Rounding for fractional shares in connection with the reverse stock split
Shares issued for vested restricted and performance stock units
10 unchanged sentences
Cash flows from operating activities:
−Removed: Adjustments to reconcile net loss to net cash used in operating activities:
+Added: Net income (loss)
+Added: Loss from discontinued operations, net of tax
+Added: Net income (loss) from continuing operations
+Added: Adjustments to reconcile net income (loss) to net cash used in continuing operating activities:
Depreciation and amortization
−Removed: Charges to provision for doubtful accounts
−Removed: Inventory charge
−Removed: Debt financing fees
Share-based payment compensation costs
−Removed: Write-off of patent and trademark
−Removed: Loss of extinguishment of debt
+Added: Make-whole payment accretion
Changes in operating assets and liabilities:
−Removed: Accounts receivable
Prepaid and other current assets
3 unchanged sentences
Total adjustments
−Removed: Net cash used in operating activities
−Removed: Cash flows from investing activities:
+Added: Net cash used in continuing operating activities
+Added: Cash flows from continuing investing activities:
Payment for patent related costs
−Removed: Payment for intellectual property license
Purchase of fixed assets
−Removed: Net cash used in investing activities
−Removed: Cash flows from financing activities:
+Added: Net cash provided by (used in) continuing investing activities
+Added: Cash flows from continuing financing activities:
Proceeds from sale of common stock, net of costs
3 unchanged sentences
Repayments of debt
−Removed: Borrowings of debt
+Added: Proceeds from Series A Preferred Stock, net of transaction costs
+Added: Repurchase of Preferred Stock at liquidation preference
+Added: Proceeds from make-whole derivative
+Added: Repayment of make-whole derivative
Payment of debt financing fees
+Added: Net cash (used in) provided by continuing financing activities
+Added: Discontinued operations:
+Added: Net cash used in operating activities
+Added: Net cash provided by investing activities
Net cash provided by financing activities
+Added: Net cash provided by (used in) discontinued operations
Net decrease in cash
−Removed: Cash, beginning of period
−Removed: Cash, end of period
+Added: Cash and restricted cash - continuing operations, beginning of period
+Added: Cash and restricted cash - discontinued operations, beginning of period
+Added: Total cash and restricted cash, end of period
Supplemental disclosure of cash flow information:
11 unchanged sentences
We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties.
−Removed: We are a women’s healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause.
−Removed: At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women.
−Removed: Our solutions range from a patient-controlled, long-lasting contraceptive to advanced hormone therapy pharmaceutical products.
−Removed: We also have a portfolio of branded and generic prescription prenatal vitamins under the vitaMedMD and BocaGreenMD brands.
−Removed: Our portfolio of products focused on women’s health allows us to efficiently leverage our sales and marketing plan to grow our recently approved products.
−Removed: Beginning in 2018, the U.S.
−Removed: Food and Drug Administration (“FDA”) approval of our pharmaceutical products transitioned our company from predominately focused on conducting research and development to one focused on commercializing our pharmaceutical products.
−Removed: In July 2018, we launched our FDA-approved product IMVEXXY (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity), a symptom of vulvar and vaginal atrophy, or VVA, due to menopause, which was approved by the FDA in May 2018.
−Removed: In April 2019, we launched our FDA-approved product BIJUVA (estradiol and progesterone) capsules, our hormone therapy combination of bioidentical 17ß-estradiol and bio-identical progesterone in a single, oral softgel capsule, for the treatment of moderate-to-severe vasomotor symptoms, or VMS, due to menopause in women with a uterus, which was approved by the FDA in October 2018.
−Removed: In October 2019, we began a “test and learn” market introduction for our FDA-approved product ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system), the first and only annual patient-controlled, procedure-free, reversible prescription contraceptive option for women, which was approved by the FDA in August 2018 and which we have licensed for commercialization in the U.S.
−Removed: pursuant to an exclusive license agreement with the Population Council, Inc.
−Removed: (the “Population Council”), or the Population Council License Agreement.
−Removed: We paused the full commercial launch of ANNOVERA in March 2020 due to the impact of the COVID-19 pandemic and resumed this initiative in July 2020.
−Removed: We have also entered into license agreements with strategic partners to commercialize IMVEXXY and BIJUVA outside of the U.S.
+Added: TherapeuticsMD was previously a women’s healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause.
+Added: In December 2022, we changed our business to become a pharmaceutical royalty company, currently receiving royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories.
+Added: On December 30, 2022 (the “Closing Date”), the Company completed a transaction (the “Mayne Transaction”) with Mayne Pharma LLC, a Delaware limited liability company (“Mayne Pharma”) and subsidiary of Mayne Pharma Group Limited, an Australian public company, pursuant to which the Company and its subsidiaries (i) granted Mayne Pharma an exclusive license to commercialize the Company’s IMVEXXY, BIJUVA and prescription prenatal vitamin products sold under the BocaGreenMD® and vitaMedMD® brands (collectively, the “Licensed Products”) in the United States and its possessions and territories, (ii) assigned to Mayne Pharma the Company’s exclusive license to commercialize ANNOVERA (together with the Licensed Products, collectively, the “Products”) in the United States and its possessions and territories, and (iii) sold certain other assets to Mayne Pharma in connection therewith.
+Added: Pursuant to a License Agreement, dated December 4, 2022, between the Company and Mayne Pharma (the “Mayne License Agreement”), the Company granted Mayne Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization in the United States and its possessions and territories.
+Added: Pursuant to the Mayne License Agreement, Mayne Pharma will make one-time, milestone payments to the Company of each of (i) $ 5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 100.0 million, (ii) $ 10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 200.0 million and (iii) $ 15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 300.0 million.
+Added: Further, Mayne Pharma will pay to the Company royalties on net sales of all Products in the United States at a royalty rate of 8.0 % on the first $ 80 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments, for a period of 20 years following the Closing Date.
+Added: The royalty rate will decrease to 2.0 % on a Product-by-Product basis upon the earlier to occur of (i) the expiration or revocation of the last patent covering a Product and (ii) a generic version of a Product launching in the United States.
+Added: Mayne Pharma will pay to the Company minimal annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3 %, subject to certain further adjustments, including as described below.
+Added: Upon the expiry of the 20 -year royalty term, the licenses granted to Mayne Pharma under the Mayne License Agreement will become a fully paid-up and royalty free license for the Licensed Products.
+Added: Pursuant to a Transaction Agreement, dated December 4, 2022, between the Company and Mayne Pharma (the “Transaction Agreement”), the Company sold to Mayne Pharma, at closing, certain assets for Mayne Pharma to commercialize the Products in the United States, including, with the Populations Council’s consent, the Company’s exclusive license from the Population Council to commercialize ANNOVERA (the “Transferred Assets”).
+Added: The total consideration from Mayne Pharma to the Company for the purchase of the Transferred Assets and the grant of the licenses under the Mayne Transaction Agreement was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition of net working capital as determined in accordance with the Transaction Agreement and subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million at closing for prepaid royalties in connection with the Mayne License Agreement Amendment (as defined below) and (iv) the right to receive the contingent consideration set forth in the
+Added: Mayne License Agreement, as amended.
+Added: The acquisition of net working capital was determined in accordance with the Transaction Agreement and included significant estimates which could change materially for a period of up to two years following the Closing Date.
+Added: On the Closing Date, the Company and Mayne Pharma entered into Amendment No.
+Added: 1 to the Mayne License Agreement (the “Mayne License Agreement Amendment”).
+Added: Pursuant to the Mayne License Agreement Amendment, Mayne Pharma agreed to pay the Company approximately $ 1.0 million in prepaid royalties on the Closing Date.
+Added: The prepaid royalties will reduce the first four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $ 257,250 per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such quarterly royalty payment is paid to the Company.
+Added: In addition, the parties agreed that Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to the Company by $ 1.5 million in consideration of Mayne Pharma assuming the Company’s obligations under a long-term services agreement (see vitaCare divestiture below), including the Company’s minimum payment obligations thereunder.
+Added: As part of the transformation that included Mayne License Agreement, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date.
+Added: Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the Company’s consolidated balance sheets.
+Added: Additional disclosures regarding discontinued operations are provided in Note 2.
+Added: The Company also has license agreements with strategic partners to commercialize IMVEXXY and BIJUVA outside of the U.S.
In July 2018, we entered into a license and supply agreement (the “Knight License Agreement”) with Knight Therapeutics Inc.
2 unchanged sentences
In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries.
+Added: In connection with the Company’s transformation into a pharmaceutical royalty company, the termination of our executive management team (except for Mr.
+Added: Marlan Walker, our former General Counsel and current Chief Executive Officer) and all other employees was completed by December 31, 2022.
+Added: Severance obligations for all employees other than executive officers were paid in full in January 2023 and severance obligations for terminated executive officers will be paid in accordance with their employment agreements and separation agreements as previously disclosed.
+Added: As of December 31, 2022, we employed 1 full-time employee primarily engaged in an executive position.
+Added: We have also entered into consulting agreements with certain former members of our management team who support our relationship with current partners and assist with certain financial, legal and regulatory matters and the continued wind-down of our historical business operations.
+Added: vitaCare Divestiture
+Added: On April 14, 2022, we completed the divestiture of vitaCare Prescription Services, Inc.
+Added: (“vitaCare”) with the sale of all of vitaCare’s issued and outstanding capital stock (the “vitaCare Divestiture”).
+Added: We received net proceeds of $ 142.6 million, net of transaction costs of $ 7.2 million, and we recognized a gain on sale of business of $ 143.4 million.
+Added: Included in the net proceeds amount was $ 11.3 million of customary holdbacks as provided in the stock purchase agreement (the “Purchase Agreement”), which is recorded as restricted cash in the consolidated balance sheets.
+Added: The restricted cash was held by an escrow agent and was be released to us in March 2023.
+Added: Additionally, we may receive up to an additional $ 7.0 million in earn-out consideration, contingent upon vitaCare’s financial performance through 2023 as determined in accordance with the terms of the Purchase Agreement.
+Added: We will record the contingent consideration at the settlement amount when the consideration is realized or realizable.
+Added: The Purchase Agreement contains customary representations and warranties, covenants, and indemnities of the parties thereto.
+Added: The commitments under a long-term services agreement related to vitaCare were transferred to Mayne Pharma as part of the Mayne Transaction.
+Added: In addition, under the Mayne License Agreement Amendment, Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to us by $ 1.5 million in consideration of Mayne Pharma assuming our obligations under the long-term services agreement related to vitaCare.
+Added: The divestiture of vitaCare was determined to be a component of discontinued operations in December 2022, when the Company changed its business by becoming a royalty company and as a result vitaCare activities were reclassified to discontinued operations for 2022 and 2021.
With multiple variant strains of the SARS-Cov-2 virus and the COVID-19 disease that it causes (collectively, “COVID-19”) still circulating, we continue to be subject to risks and uncertainties in connection with the COVID-19 pandemic.
The extent of the future impact of the COVID-19 pandemic on our business continues to be highly uncertain and difficult to predict.
−Removed: The ultimate global recovery from the pandemic will be dependent on, among other things, actions taken by governments and businesses to contain and combat the virus, including any variant strains, the speed and effectiveness of vaccine production and global distribution, as well as how quickly, and to what extent, normal economic and operating conditions can resume on a sustainable basis globally.
−Removed: Since the early phase of the COVID-19 pandemic, we have been using substantial virtual options to ensure business continuity.
−Removed: We have also partnered with independent community pharmacies and multiple third-party online pharmacies and telemedicine providers that focus on contraception or menopause which provide patients real-time access to both diagnosis and treatment.
−Removed: We continue to support prescribers’ needs with samples and product materials through our sales force.
−Removed: If access is restricted, we have mailing options in place for these materials.
−Removed: We also have business continuity plans and infrastructure in place that allows for live virtual e-detailing of our products.
−Removed: As part of our response to the COVID-19 pandemic, we implemented measures to reduce marketing expenses for 2020 and we also implemented cost saving measures in 2020 and 2021, which included negotiating lower fees or suspending services from third-party vendors;
−Removed: implementing a company-wide hiring restriction;
−Removed: delaying or cancelling non-critical information technology projects;
−Removed: and eliminating non-essential travel, entertainment, meeting, and event expenses.
−Removed: In addition, we implemented a significant cost savings initiative that is designed to reduce our annual costs in 2022 by at least $ 40.0 million.
−Removed: This figure does not include estimated annualized cost savings of approximately $ 20.0 million from, or the costs associated with the sale of vitaCare for which we signed a definitive agreement on March 6, 2022.
−Removed: See Note 17 – Subsequent events for a description of the vitaCare divestiture.
−Removed: The full impact of the COVID-19 pandemic continues to evolve.
−Removed: However, we remain committed to the execution of our corporate goals, despite the ongoing COVID-19 pandemic, as demonstrated in part by the increase in product revenue throughout 2021.
−Removed: As of the date of issuance of these consolidated financial statements, the future extent to which the COVID-19 pandemic may continue to materially impact our financial condition, liquidity, or results of operations remains uncertain.
−Removed: We are continuing to assess the effect of the COVID-19 pandemic on our operations by monitoring the spread of COVID-19 and the various actions implemented to combat the pandemic throughout the world.
+Added: As of the date of issuance of these consolidated financial statements, the future extent to which the COVID-19 pandemic may continue to materially impact our financial condition, liquidity, or results of operations remains uncertain and difficult to predict.
Even after the COVID-19 pandemic has subsided, we may continue to experience adverse impacts to our business as a result of any economic recession or depression that has occurred or may occur in the future.
−Removed: While we currently believe that our COVID-19 contingency plan has the ability to mitigate many of the negative effects of the COVID-19 pandemic on our business, the severity of the impact of the COVID-19 pandemic on our business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic, the duration of “social distancing” orders, the ability of our sales force to access healthcare providers to promote our products, increases in unemployment, which could reduce access to commercial health insurance for our patients, thus limiting payer coverage for our products, and the impact of the pandemic on our global supply chain, all of which remain uncertain.
−Removed: Our future results of operations and liquidity could be materially adversely affected by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions, uncertain demand, and the impact of any initiatives or programs that we may undertake to address financial and operations challenges that we may face.
Going Concern
−Removed: We incurred a net loss of $ 172.4 million during the year ended December 31, 2021, and as of that date, our current liabilities exceeded our current assets by $ 133.4 million and our total liabilities exceeded our total assets by $ 93.6 million.
−Removed: We will need to raise additional capital to repay the entire principal balance of our Financing Agreement, which matures on June 1, 2022, and to provide additional liquidity to fund our losses until our operations become cash flow positive.
−Removed: To address our capital needs, we are pursuing various equity and debt financing and other alternatives, including the sale of vitaCare for which we signed a definitive agreement on March 6, 2022.
+Added: On December 4, 2022, we entered into agreements with Mayne Pharma pursuant to which we granted Mayne Pharma an exclusive license to commercialize IMVEXXY, BIJUVA, and prescription prenatal vitamin products (in the United States and its possessions and territories), (ii) assign to Mayne Pharma the Company’s exclusive license to commercialize ANNOVERA in the United States and its possessions and territories, and (iii) sell certain other assets to Mayne Pharma.
+Added: The total consideration from Mayne Pharma to the Company for the purchase of the Transferred Assets and the grant of the licenses under the License Agreement was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition of net working capital subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million at closing for prepaid royalties in connection with the License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the License Agreement, as amended.
+Added: On the Closing Date, we repaid all obligations under the Financing Agreement, dated as of April 24, 2019, as amended, with Sixth Street Specialty Lending, Inc., as administrative agent, the various lenders from time-to-time party thereto, and certain of the Company’s subsidiaries party thereto from time to time as guarantors (the “Financing Agreement”) and the Financing Agreement was terminated.
+Added: Following the transaction with Mayne Pharma, our primary source of revenue will be from royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories.
+Added: We may need to raise additional capital to provide additional liquidity to fund our operations until we become cash flow positive.
+Added: To address our capital needs, we may pursue various equity and debt financing and other alternatives.
The equity financing alternatives may include the private placement of equity, equity-linked, or other similar instruments or obligations with one or more investors, lenders, or other institutional counterparties or an underwritten public equity or equity-linked securities offering.
−Removed: Our ability to sell equity securities may be limited by market conditions, including the market price of our common stock and the potential delisting of our common stock from the Nasdaq Global Select Market, and our available authorized shares.
+Added: Our ability to sell equity securities may be limited by market conditions, including the market price of our common stock, and our available authorized shares.
+Added: Our ability to sell equity securities may be limited by market conditions, including the market price of our common stock and our available authorized shares.
To the extent that we raise additional capital through the sale of such securities, the ownership interests of our existing stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders.
If we are not successful in obtaining additional financing, we could be forced to discontinue or curtail our business operations, sell assets at unfavorable prices, or merge, consolidate, or combine with a company with greater financial resources in a transaction that might be unfavorable to us.
−Removed: Along with considering additional financings, we have reviewed numerous potential scenarios in connection with steps that we may take to reduce our operating expenses.
−Removed: Based on our analysis, we believe that our existing cash reserves along with potential proceeds from the sale of certain non-core assets of the Company and proceeds from potential future financings, if available to us, would be sufficient to meet our cash needs arising in the ordinary course of business for the next twelve months from the date of this 2021 10-K Report.
−Removed: If we are unsuccessful with future financings and if the successful commercialization of IMVEXXY, BIJUVA, or ANNOVERA is delayed, or the continued impact of the COVID-19 pandemic or issues in our supply chains related to our third-party contract manufacturers on our business is worse than we anticipate, our existing cash reserves would be insufficient to maintain compliance with the Financing Agreement covenants or satisfy our liquidity.
−Removed: See “Inventory” in Note 3 for additional information regarding risks associated with our contract manufacturers, particularly for ANNOVERA.
−Removed: The presence of these projected factors in conjunction with
−Removed: the uncertainty of the capital markets raises substantial doubt about the Company's ability to continue as a going concern for the next twelve months from the issuance of these financial statements.
+Added: If Mayne Pharma’s sales of IMVEXXY, BIJUVA, or ANNOVERA are delayed, if the net working capital settlement with Mayne Pharma under the Transaction Agreement, or if we are unsuccessful with future financings and or the continued impact of the COVID-19 pandemic or the supply chains related to the third-party contract manufacturers is worse than we anticipate, our existing cash reserves would be insufficient to satisfy our liquidity.
+Added: The presence of these projected factors in conjunction with the uncertainty of the capital markets raises substantial doubt about the Company's ability to continue as a going concern for the next twelve months from the issuance of these financial statements.
The accompanying consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
4 unchanged sentences
All intercompany transactions among our businesses have been eliminated.
+Added: As part of the transformation as a result of Mayne License Agreement, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date.
+Added: Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the Company’s consolidated balance sheets.
+Added: Additional disclosures regarding discontinued operations are provided in Note 2.
Certain amounts in the n otes to the consolidated financial statements may not add due to rounding, and all percentages have been calculated using unrounded amounts.
5 unchanged sentences
Facilitation of the Effects of Reference Rate Reform on Financial Reporting and Scope.
−Removed: In March 2020 and January 2021, Accounting Standards Update (“ASU”) 2020-04 and ASU 2021-01 were issued, respectively.
These ASUs provide optional guidance for a limited period of time to ease potential accounting impacts associated with transitioning away from reference rates that are expected to be discontinued, such as London Interbank Offered Rate (LIBOR).
2 unchanged sentences
These ASUs were effective upon issuance and may be applied prospectively to contract modifications made or evaluated on or before December 31, 2022.
−Removed: Our debt agreements currently include the use of alternate rates when LIBOR is not available.
−Removed: We do not expect the change from LIBOR to an alternate rate will have a material impact to our financial statements and, to the extent we enter into modifications of agreements that are impacted by the LIBOR phase-out, we will apply such guidance to those contract modifications.
+Added: We paid off our debt as of December 30, 2022, and as a result the adoption of this guidance will not have an impact on our financial statements and, to the extent we enter into new debt agreements, we will apply such guidance to those contracts.
Other recently issued accounting standards not yet adopted by us are not expected, upon adoption, to have a material impact on the Company’s consolidated financial statements or processes.
+Added: Discontinued Operations
+Added: Discontinued operations comprise activities that were disposed of at the end of the period, represent a separate major line of business that can be clearly distinguished for operational and financial reporting purposes and represent a business shift having a major effect on the Company’s operations and financial results according to Accounting Standard Codification (“ASC”) Topic 205, Presentation of Financial Statements.
+Added: An adjustment has been made to the consolidated statements of operations for the twelve months ended December 31, 2022 and 2021 to reclassify commercial activities and vitaCare activities to discontinued operations as both components, in the aggregate, represented a business shift that will have a major effect on the Company’s operations and financial results.
+Added: No amounts for shared general and administrative operating support expense were allocated to discontinued operations.
+Added: As required by the terms of our Financing Agreement, the proceeds from both transactions were used to fully repay our outstanding debt borrowings.
+Added: As a result, interest expense and amortization of deferred financing costs as well as expense for accretion of Series A Preferred Stock and loss on extinguishment of debt are included within income (loss) from discontinued operations, net of tax.
+Added: Additionally, the related assets and liabilities have been reported as assets and liabilities of discontinued operations in the Company’s consolidated balance sheet as of December 31, 2022 and 2021.
+Added: For additional information, see Note 2 - Discontinued Operations.
Estimates and assumptions
3 unchanged sentences
Actual results may differ, at times in material amounts, from these estimates under different assumptions or conditions.
+Added: Cash and Restricted Cash
We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $ 0.25 million per bank.
We have never experienced any losses related to these funds.
+Added: Restricted cash is comprised of escrowed funds deposited with a bank relating to the vitaCare Divestiture.
+Added: All restrictions were lifted in March 2023 and it is no longer restricted, see Note 15.
Accounts receivable and allowance for doubtful accounts
Accounts receivable are customer obligations due under normal trade terms and are measured at amortized cost.
−Removed: We extend credit on an unsecured basis to most of our customers based on an evaluation of a customer’s financial condition, and collateral is not required.
−Removed: Our accounts receivable concentration of credit risk is primarily limited customers who are drug wholesalers and retail pharmacy distributors.
−Removed: We review accounts receivable for uncollectible and delinquent accounts and credit card chargebacks, and we provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, reasonable supportable
−Removed: forecasts, and existing economic conditions , and we record an allowance that presents the net amount expected to be collected.
+Added: We historically extended credit on an unsecured basis to most of our customers based on an evaluation of a customer’s financial condition, and collateral was not required.
+Added: Our accounts receivable concentration of credit risk is primarily limited to customers who are drug wholesalers and retail pharmacy distributors.
+Added: We review accounts receivable for uncollectible and delinquent accounts and credit card chargebacks, and we provide an allowance for doubtful accounts, which is based upon a review of outstanding receivables, historical collection information, reasonable supportable forecasts, and existing economic conditions, and we record an allowance that presents the net amount expected to be collected.
We write off uncollectible and delinquent receivables against our allowance for doubtful accounts based on individual credit evaluations, the results of collection efforts, and specific circumstances of customers.
3 unchanged sentences
Although we have historically not experienced significant credit losses, it is possible that there could be a material adverse impact from potential adjustments of the carrying amount of trade receivables in the future.
−Removed: Inventories represent pharmaceutical products, packaged vitamins and raw materials which are valued at the lower of cost or net realizable value.
+Added: On December 30, 2022, Mayne Pharma acquired our accounts receivable balance of approximately $ 29.3 million which is subject to certain working capital adjustments.
+Added: Inventories are valued at the lower of cost or net realizable value.
Our pharmaceutical products are valued using first in first out method and our vitamins are valued using the average-cost method.
1 unchanged sentence
Obsolescence may occur due to product expiring, product improvements rendering previous versions obsolete, or decreases in demand for our products.
+Added: On December 30, 2022, Mayne Pharma acquired our inventory balance of approximately $ 8.4 million , which is subject to certain net working capital adjustments.
Fair Value Measurements
9 unchanged sentences
Level 3 - Inputs that are unobservable.
−Removed: The carrying amount of our cash, accounts receivable, accounts payable and accrued expenses approximate their fair value because of the short-term maturity of such instruments, which are considered Level 1 under the fair value hierarchy.
−Removed: The carrying amount of our debt approximates fair value since it bears interest either at variable rates or fixed rates which are not significantly different from market rates, which are considered Level 2 under the fair value hierarchy.
+Added: The carrying amount of our cash, restricted cash, accounts receivable, accounts payable and accrued expenses approximate their fair value because of the short-term maturity of such instruments, which are considered Level 1 under the fair value hierarchy.
Fixed assets are carried at cost less accumulated depreciation and amortization.
9 unchanged sentences
We record license rights and other intangible assets at cost, which includes external costs, consisting primary of legal costs, incurred in securing our patents and trademarks.
−Removed: We started amortizing license rights cost once ANNOVERA became commercially available for use.
−Removed: License rights cost is amortized over the useful life over which the license rights will contribute directly or indirectly to our cash flows, which is estimated to be the remaining patent life of ANNOVERA, expiring in June 2039 .
−Removed: The cost is amortized using the straight-line method as the pattern of economic benefit cannot be reliably determined.
+Added: License rights cost related to ANNOVERA were amortized until December 30, 2022 over the useful life over which the license rights would contribute directly or indirectly to our cash flows.
+Added: The cost was amortized using the straight-line method as the pattern of economic benefit could not be reliably determined.
+Added: On December 30, 2022, we assigned our ANNOVERA license to Mayne Pharma and included the remaining ANNOVERA license cost of $ 30.2 million in our calculation of the gain on sale of assets.
+Added: In addition, amortization of license rights of $ 3.0 million for years 2022 and 2021 was reclassified to discontinued operations.
Intangible assets subject to amortization, such as patents, are amortized over the useful life of the patent using the straight-line method.
4 unchanged sentences
Segment reporting
−Removed: We manage and operate as one business, which is focused on creating and commercializing products targeted exclusively for women.
−Removed: Our business operations are managed by a single executive leadership team, which is led by our chief executive officer.
+Added: We manage and operate as one business, which prior to December 2022 was focused on creating and commercializing products targeted exclusively for women and after we signed Mayne License Agreement, is focused on collecting royalties from licensing our products.
+Added: Our business is led by our chief executive officer.
We do not operate separate lines of business with respect to any of our products, and we do not prepare discrete financial information with respect to separate products.
−Removed: All product sales are derived from sales within the United States.
Accordingly, we view our business as one reportable operating segment.
−Removed: With one geographic location.
Revenue recognition
5 unchanged sentences
Recognition of revenue when or as we satisfy the performance obligations.
−Removed: Essentially all of our revenue is generated through contracts with our customers, who are primarily wholesale distributors and retail pharmacies.
+Added: Essentially all of our revenue is generated through contracts with our customers.
A performance obligation is a promise in a contract to transfer a product or service to a customer.
1 unchanged sentence
We generally recognize revenue at a point in time when all of our performance obligations under the terms of a contract are satisfied.
−Removed: Revenue is recognized upon transfer of control of promised products or services in an amount that reflects the consideration we expect to receive in exchange for those products or services.
+Added: Revenue is recognized upon transfer of control of promised products or services in an amount that reflects the consideration we expect to receive in exchange
+Added: for those products or services.
The collectability of consideration on the contract is reasonably assured before revenue is recognized.
1 unchanged sentence
Prescription products
−Removed: Prescription products are sold at fixed wholesale acquisition cost, or WAC, determined based on our list price.
−Removed: However, the total transaction price is variable as it is calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees.
−Removed: These estimates are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer).
−Removed: To determine the transaction price, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract or each variable consideration.
−Removed: The estimated amount of variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative product revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
−Removed: In determining amounts of variable consideration to include in a contract’s transaction price, we
−Removed: rely on our historical experience and other evidence that supports our qualitative assessment of whether product revenue would be subject to a significant reversal.
−Removed: We consider all the facts and circumstances associated with both the risk of a product revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur.
−Removed: Actual amounts of consideration ultimately received may differ from our estimates.
−Removed: If actual results in the future vary from our original estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known.
−Removed: We accept returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration.
−Removed: ANNOVERA cannot be returned before the expiration date and expired ANNOVERA can be returned up to 12 months past the expiration date.
−Removed: Our prescription vitamins, IMVEXXY and BIJUVA currently have a shelf life of 24 months from the date of manufacture and ANNOVERA currently has a shelf life of 18 months from the date of manufacture.
−Removed: We do not allow product returns for prescription products that have been dispensed to a patient.
−Removed: We estimate the amount of our product sales that may be returned by our customers and record this estimate as a reduction of product revenue in the period the related product revenue is recognized.
−Removed: Where historical rates of return exist, we use history as a basis to establish a returns reserve for products shipped to wholesalers.
−Removed: For our newly launched products, for which the right of return exists but for which we currently do not have history of product returns, we estimate returns based on available industry data, our own sales information and our visibility into the inventory remaining in the distribution channel.
−Removed: At the end of each reporting period, we may decide to constrain product revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products currently being shipped, price changes of competitive products and any introductions of generic products.
−Removed: We recognize the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration.
−Removed: Since our returns primarily consist of expired and short dated products that will not be resold, we do not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of product revenue is deferred due to the anticipated return).
−Removed: We offer various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty.
−Removed: We estimate the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which is reviewed and adjusted, if necessary, on a quarterly basis.
−Removed: We record distributor fees based on amounts stated in contracts.
−Removed: We estimate chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience.
−Removed: We provide discounts to our customers for prompt payment.
−Removed: Consumer rebates and coupons costs, distribution fees, chargebacks and discounts are deducted from gross product revenue at the time the product revenue is recognized.
−Removed: For our prescription products, we offer a co-pay assistance program for eligible enrolled patients whose out of pocket costs are reduced to a more affordable price.
−Removed: This allows patients to access the product at a reasonable cost and is in line with our responsible pricing approach.
−Removed: We reimburse pharmacies for this discount through third-party vendors.
−Removed: The variable consideration is estimated based on contract prices, the estimated percentage of patients that will utilize the copay assistance, the average assistance paid, the estimated levels of inventory in the distribution channel and the current level of prescriptions covered by patients’ insurance.
−Removed: Payers may change coverage levels for our prescription products positively or negatively, at any time up to the time that we have formally contracted coverage with the payer.
−Removed: As such, the net transaction price of our prescription products is susceptible to such changes in coverage levels, which are outside the influence of the Company.
−Removed: As a result, we constrain variable consideration for our prescription products to an amount that will not result in a significant product revenue reversal in future periods.
−Removed: Our ability to estimate the net transaction price for our prescription products is constrained by our estimates of the amount to be paid for the co-pay assistance program which is directly related to the level of prescriptions paid for by insurance.
−Removed: As such, we record an accrual to reduce gross sales for the estimated co-pay and other patient assistance based on currently available third-party data and our internal analyses.
−Removed: We re-evaluate variable consideration each reporting period.
+Added: On December 30, 2022, we granted an exclusive license to commercialize our prescription products and assigning the Company’s exclusive license to commercialize ANNOVERA to Mayne Pharma, which resulted in a business shift that had a major effect on our operations and financial results.
+Added: As part of the transformation that included the Mayne License Agreement, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date.
+Added: As of December 31, 2022, we are no longer directly engaged in the sale of prescription products.
+Added: Prior to the business shift in December 2022, prescription products were sold at fixed wholesale acquisition cost, or WAC, determined based on our list price.
+Added: However, the total transaction price was variable as it was calculated net of estimated product returns, chargebacks, rebates, coupons, discounts and wholesaler fees.
+Added: These estimates were based on the amounts earned or to be claimed on the related sales and were classified as reductions of accounts receivable (if the amount was payable to the customer) or a current liability (if the amount was payable to a party other than a customer).
+Added: To determine the transaction price, we estimated the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract or each variable consideration.
+Added: The estimated amount of variable consideration was included in the transaction price only to the extent that it was probable that a significant reversal in the amount of cumulative product revenue recognized would not occur when the uncertainty associated with the variable consideration was subsequently resolved.
+Added: In determining amounts of variable consideration to include in a contract’s transaction price, we relied on our historical experience and other evidence that supported our qualitative assessment of whether product revenue would be subject to a significant reversal.
+Added: We considered all the facts and circumstances associated with both the risk of a product revenue reversal arising from an uncertain future event and the magnitude of the reversal if that uncertain event were to occur.
+Added: Actual amounts of consideration ultimately received could differ from our estimates.
+Added: If actual results in the future varied from our original estimates, we would adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known.
+Added: We accepted returns of unsalable prescription products sold through wholesale distributors within a return period of six months prior to and up to 12 months following product expiration.
+Added: ANNOVERA can not be returned before the expiration date and expired ANNOVERA can be returned up to 12 months past the expiration date.
+Added: Our prescription vitamins, IMVEXXY and BIJUVA have a shelf life of 24 months from the date of manufacture and ANNOVERA currently has a shelf life of 18 months from the date of manufacture.
+Added: We did not allow product returns for prescription products that have been dispensed to a patient.
+Added: We estimated the amount of our product sales that could be returned by our customers and recorded this estimate as a reduction of product revenue in the period the related product revenue was recognized.
+Added: Where historical rates of return existed, we used history as a basis to establish a returns reserve for products shipped to wholesalers.
+Added: For newly launched products, for which the right of return existed but for which we did not have history of product returns, we estimated returns based on available industry data, our own sales information and our visibility into the inventory remaining in the distribution channel.
+Added: At the end of each reporting period, sometimes we constrained product revenue, if necessary, for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of products being shipped, price changes of competitive products and any introductions of generic products.
+Added: We recognized the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration.
+Added: Since our returns primarily consisted of expired and short dated products that would not be resold, we did not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of product revenue is deferred due to the anticipated return).
+Added: We offered various rebate and discount programs in an effort to maintain a competitive position in the marketplace and to promote sales and customer loyalty.
+Added: We estimated the allowance for consumer rebates and coupons that we have offered based on our experience and industry averages, which was reviewed and adjusted, if necessary, on a quarterly basis.
+Added: We recorded distributor fees based on amounts stated in contracts.
+Added: We estimated chargebacks based on number of units sold during the period taking into account prices stated in contracts and our historical experience.
+Added: We provided discounts to our customers for prompt payment.
+Added: Consumer rebates and coupons costs, distribution fees, chargebacks and discounts were deducted from gross product revenue at the time the product revenue was recognized.
+Added: For our prescription products, we offered a co-pay assistance program for eligible enrolled patients whose out of pocket costs were reduced to a more affordable price.
+Added: This allowed patients to access the product at a reasonable cost and was in line with our responsible pricing approach.
+Added: We reimbursed pharmacies for this discount through third-party vendors.
+Added: The variable consideration was estimated based on contract prices, the estimated percentage of patients that would utilize the copay assistance, the average assistance paid, the estimated levels of inventory in the distribution channel and the current level of prescriptions covered by patients’ insurance.
+Added: Payers could change coverage levels for our prescription products positively or negatively, at any time up to the time that we have formally
+Added: contracted coverage with the payer.
+Added: As such, the net transaction price of our prescription products was susceptible to such changes in coverage levels, which was outside the influence of the Company.
+Added: As a result, we constrain ed variable consideration for our prescription products to an amount that would not result in a significant product revenue reversal in future periods.
+Added: Our ability to estimate the net transaction price for our prescription products was constrained by our estimates of the amount to be paid for the co-pay assistance program which was directly related to the level of prescriptions paid for by insurance.
+Added: As such, we record ed an accrual to reduce gross sales for the estimated co-pay and other patient assistance based on currently available third-party data and our internal analyses.
+Added: We re-evaluate d variable consideration each reporting period.
License revenue
2 unchanged sentences
Non-refundable up-front fees that are not contingent on any future performance by us, and do not require continuing involvement on our part, are recognized as revenue when the right to use functional intellectual property is transferred to the customer.
−Removed: Cost of sales
−Removed: Cost of sales includes the cost of inventory, manufacturing, manufacturing overhead and supply chain costs and product shipping and handling costs.
−Removed: The Population Council License Agreement requires royalty payments based on our net sales of ANNOVERA, which are recorded as a component of cost of sales.
−Removed: Additionally, the amortization costs of license rights are recorded as a component of cost of sales.
+Added: On December 30, 2022, we and closed the Mayne Transaction pursuant to which we sold to Mayne Pharma the exclusive license rights in our product ANNOVERA and granted an exclusive license in other products, including IMVEXXY and BIJUVA (together, the three products being the “Licensed Products” - see Note 1).
+Added: Under the terms of the Mayne License Agreement, we received $ 140 million at closing and we are eligible to receive additional payments in the aggregate of up to an additional $ 30 million, based on the achievement of sales milestones (collectively, the “Milestone Amounts”).
+Added: The proceeds at closing were allocated between consideration for the sale of ANNOVERA and the initial license fee for the Licensed Products, as the sale of ANNOVERA was accounted for under ASC 610-20, Gains and Losses from Derecognition of Nonfinancial Assets in arriving at the gain on disposal (see Note 2), while the license grant of the other products were recognized under the provisions of ASC 606, Revenue from Contracts with Customers, as a license of functional intellectual property.
+Added: The proceeds were allocated among the Licensed Products on the relative net present value of forecasted future product sales from those products.
+Added: The Milestone Amounts will be recognized, as applicable, in subsequent periods based on actual product sales that exceed the respective net sales milestones as such variable consideration is constrained by the occurrence of the subsequent sales.
+Added: Our royalty revenue in 2022 related to royalties provided for under the Mayne License Agreement based on Mayne Pharma’s sales of the licensed products subject to that agreement.
+Added: Under the Mayne License Agreement, the Company is entitled to earn royalties on net sales of all of the Licensed Products at a royalty rate of (i) 8 % on the first $ 80 million of net sales of the Licensed Products and (ii) 7.5 % on net sales of all of the Licensed Products after the first $ 80 million of net sales.
+Added: The royalty rate is subject to a 2 % reduction upon the earlier to occur of (i) the expiration or revocation of the last valid claim covering a Licensed Product, and (ii) a generic product launch (a “LOE”).
+Added: We are entitled to minimum annual royalties beginning with the year ending December 31, 2023 ($ 3 million annual minimum) and continuing with 3 % annual increases through the year ending December 31, 2034 (the “Minimum Annual Royalty”).
+Added: The total Minimum Annual Royalty we are entitled to is $ 42.6 million, and this total amount was allocated among the Licensed Products on the relative net present value of forecasted future product sales from those products.
+Added: The portion allocated to consideration for the sale of ANNOVERA was attributed towards the gain on disposal of that asset.
+Added: For the remaining portion allocated to the license grants for the other products, we determined that the minimum guarantee underlying the Minimum Annual Royalty should be treated as fixed consideration and recognized under ASC 606 at the point in time when the license was transferred.
+Added: Since the Minimum Annual Royalty will be received in annual installments through 2034, we determined the transaction price allocated under ASC 606 contained a significant financing component, and we therefore determined the initial royalty revenue and corresponding receivable based on the present value of the allocated Minimum Annual Royalty.
+Added: The present value was calculated using a discount rate of 10.45 %, based on the credit characteristics of Mayne Pharma and the timing of future payments, and the value will be accreted to full value through the earlier of January 1, 2034 or a LOE.
+Added: This royalty receivable is a contract asset as of December 31, 2022, and is further subject to offset by Mayne Pharma (see N.
+Added: Contract Assets and Liabilities below).
+Added: Royalty revenue earned in excess of the Minimum Annual Royalty will be recognized under ASC 606, which provides revenue recognition constraints by requiring the recognition of revenue at the later of the following:
+Added: 1) when the subsequent sale occurs or 2) when the performance obligation to which some or all of the sales-based royalty has been allocated has been satisfied (or partially satisfied).
+Added: We applied the royalty recognition constraint required under the guidance for sales-based royalties, which requires a sales-based royalty to be recorded no sooner than the underlying sale.
+Added: Therefore, royalties on sales of products commercialized by Mayne Pharma will be recognized in the subsequent periods that the Licensed Products are sold.
+Added: In 2021, we received milestone payments comprised of an aggregate of EUR 1.0 million, or $ 1.2 million, in regulatory milestone payments based on regulatory approvals for BIJUVA in certain specified markets.
+Added: In 2022 and 2021, we recorded BIJUVA sales of $ 1.4 million made through the Theramex License Agreement which was recorded as license revenue.
+Added: Cost of revenue
+Added: Cost of revenue includes the cost of inventory, manufacturing, manufacturing overhead and supply chain costs and product shipping and handling costs.
+Added: Costs related to the Population Council License Agreement, which were based on our net sales of ANNOVERA, and amortization of license rights were reclassified to discontinued operations for 2022 and 2021 as a result of the transaction with Mayne Pharma.
+Added: Contract Assets and Liabilities
+Added: Contract assets as of December 31, 2022, include royalties recognized from the Minimum Annual Royalty (see L.
+Added: Revenue Recognition above).
+Added: Pursuant to the Mayne License Agreement, this asset was reduced in December 2022 by $ 1.5 million in consideration for Mayne Pharma assuming an obligation payable to vitaCare, and will be further reduced, other than from future payments on receivables from Mayne Pharma, for $ 1.0 million in prepaid royalties that we received from Mayne Pharma on the closing date.
+Added: The prepaid royalties will reduce the first four quarterly payments that would have otherwise been payable to us under the Minimum Annual Royalty by an amount equal to $ 257,250 per quarter plus interest calculated at 19 % per annum.
Research and development
−Removed: Research and development expenses include internal R&D activities, costs of services of third-party contract research organizations (“CROs”) and usage of their clinical research sites, manufacturing, scale-up and validation costs, and other activities.
−Removed: Internal R&D activity expenses include laboratory supplies, salaries, benefits, and share-based payment award compensation costs.
−Removed: CRO activity expenses include preclinical laboratory experiments and clinical trial studies.
−Removed: Other activity expenses include regulatory consulting and other costs.
−Removed: The activities undertaken by our regulatory consultants that were classified as R&D expenses include assisting, consulting with, and advising our in-house staff with respect to various FDA submission processes, clinical trial processes, and scientific writing matters, including preparing protocols and FDA submissions.
−Removed: These consulting expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs.
−Removed: We charge internal R&D activities and other activity expenses to operations as incurred.
−Removed: We make payments to CROs based on agreed-upon terms, which may include payments in advance of a study starting date.
−Removed: We expense nonrefundable advance payments for goods and services that will be used in future R&D activities when the activity has been performed or when the goods have been received rather than when the payment is made.
−Removed: We review and accrue CRO expenses and clinical trial study expenses based on services performed and rely on estimates of those costs applicable to the completion stage of a study as provided by CROs.
−Removed: Estimated accrued CRO costs are subject to revisions as such studies progress to completion.
−Removed: We charge revisions to expenses in the period in which the facts that give rise to the revision become known.
+Added: Research and development expenses included internal R&D activities, costs of services of third-party contract research organizations (“CROs”) and usage of their clinical research sites, manufacturing, scale-up and validation costs, and other activities.
+Added: Internal R&D activity expenses included laboratory supplies, salaries, benefits, and share-based payment award compensation costs.
+Added: CRO activity expenses included preclinical laboratory experiments and clinical trial studies.
+Added: Other activity expenses included regulatory consulting and other costs.
+Added: These consulting expenses were direct costs associated with preparing, reviewing, and undertaking work for our clinical trials and investigative drugs which were reclassified to discontinued operations for 2022 and 2021 as a result of the transaction with Mayne Pharma.
+Added: As of December 31, 2022, we do no t have any ongoing research and development activities.
Share-based payment awards
2 unchanged sentences
We have elected to account for forfeitures as they occur.
+Added: Common stock reverse stock split
+Added: On May 6, 2022, we completed a reverse stock split of our Common Stock.
+Added: As a result, outstanding shares of our Common Stock were split at a ratio of 50- for-1 (the “Reverse Stock Split”) with any fractional shares resulting from the Reserve Stock Split rounded up to the next whole share of Common Stock.
+Added: The number of authorized shares of Common Stock was also correspondingly reduced from 600.0 million shares to 12.0 million shares to give effect to the Reverse Stock Split.
+Added: Additionally, all rights to receive shares of Common Stock under outstanding warrants, options, restricted stock units (“RSUs”) and performance stock units (“PSUs”) were adjusted to give effect of the Reverse Stock Split.
+Added: Furthermore, remaining shares of Common Stock available for future issuance under share-based payment award plans and our employee stock purchase plan were adjusted to give effect of the Reverse Stock Split.
+Added: Pursuant to Section 78.209 of the Nevada Revised Statutes, the approval of our stockholders was not required for our Board of Directors (the “Board”) to effectuate the Reverse Stock Split.
+Added: All historical number of shares of Common Stock and per share data have been adjusted to give effect to the Reverse Stock Split.
+Added: Additionally, since the Common Stock par value was unchanged, historical amounts for Common Stock and additional paid-in capital have been adjusted to give effect to the Reverse Stock Split.
Income taxes are accounted for under the asset and liability method.
4 unchanged sentences
Our evaluation is based on estimates, assumptions, and includes an analysis of available positive and negative evidence, giving weight based on the evidence’s relative objectivity.
−Removed: Sources of positive evidence include estimates of future taxable income, future reversal of existing taxable temporary differences, taxable income in carryback years, and available tax planning strategies.
+Added: Sources of positive evidence include estimates of future taxable income, future reversal of existing
+Added: taxable temporary differences, taxable income in carryback years, and available tax planning strategies.
Sources of negative evidence include current and cumulative losses in recent years, losses expected in early future years, any history of operating losses or tax credit carryforwards expiring unused, and unsettled circumstances that, if unfavorably resolved, would adversely affect future profit levels.
12 unchanged sentences
Under the treasury stock method, an increase in the fair market value of our common stock can result in a greater dilutive effect from potentially dilutive securities.
−Removed: We adopted ASU 2016-02, Leases (Topic 842), including the related codification amendments, in 2019 utilizing the modified retrospective transition method and applying the transition provisions at the effective date.
We determine if an arrangement is a lease at inception.
12 unchanged sentences
When a loss is reasonably possible (the chance of the future event or events occurring is more than remote but less than likely), no accrual is recognized .
−Removed: Accounts receivable
−Removed: The following sets forth activities in our allowance for credit losses (in thousands):
−Removed: Balance as of beginning of period
−Removed: Charges to provision for credit losses
−Removed: Write-off of uncollectible receivables
−Removed: Balance as of end of period
−Removed: We rely on third parties to manufacture our finished products, and we have entered into long-term supply agreements for the manufacture of ANNOVERA, IMVEXXY, and BIJUVA.
−Removed: We do not have a long-term supply agreement for the manufacture of our prescription vitamins.
−Removed: Additionally, we do not have long-term contracts for the supply of all the active pharmaceutical ingredient (“API”) used in ANNOVERA and BIJUVA.
−Removed: One of our third-party contract manufacturers that manufactures ANNOVERA has recently experienced an increase in difficulties with manufacturing of ANNOVERA, which has resulted in intermittent supply of ANNOVERA for commercial distribution.
−Removed: The challenges are multifactorial and include variability in raw material supply and normal manufacturing variation due to a semi-manual process.
−Removed: This has recently resulted in challenges to supply ANNOVERA consistently within the approved specification at a rate that meets the projected demand for ANNOVERA.
−Removed: To mitigate the manufacturing challenges, in August 2021, we filed a supplemental New Drug Application (“NDA”) with the FDA to modify the testing specifications for ANNOVERA to allow increased consistency of supply of ANNOVERA.
−Removed: In December 2021, FDA determined that it could not approve supplemental NDA without additional information.
−Removed: In its complete response letter (“CRL”), the FDA provided recommendations and requested additional information that could support approval of revisions to certain testing specifications.
−Removed: In January 2022, we responded to the CRL, and provided the requested additional information to the FDA and modified the request for the manufacturing testing limits based on the FDA recommendations.
−Removed: We expect a response from the FDA by the end of second quarter of 2022.
−Removed: We will continue to manufacture and supply ANNOVERA under the existing specifications.
−Removed: In the meantime, our third-party contract manufacturer may not be able to supply us with sufficient ANNOVERA to adequately supply the market, which would have an adverse effect on our business, results of operations and financial condition.
−Removed: Additionally, we may incur increased write-offs of ANNOVERA products manufactured in 2022 that do not meet existing specifications.
−Removed: We have also experienced a greater than expected amount of raw materials for ANNOVERA being out of specification.
−Removed: If any of our third-party contract manufacturers or any suppliers of raw materials or API experience further difficulties, do not comply with the terms of an agreement between us, or do not devote sufficient time, energy, and care to providing our manufacturing needs, or if the manufacturing specification modifications that we have requested are not approved by the FDA, we could experience additional interruptions in the supply of our products, which may have a material adverse impact on our revenue, results of operations and financial position.
−Removed: Our inventory consisted of the following (in thousands):
+Added: Restructuring charges
+Added: During the year ended December 31, 2022, the Company initiated and completed a restructuring plan that resulted in a reduction of its workforce to one employee.
+Added: One-time termination benefits include severance, continuation of health insurance coverage, and other benefits for a specified period of time, as well as contract terminations and fixed assets write-downs, which resulted in $ 15.7 million of restructuring costs for the year ended December 31, 2022.
+Added: These costs have been recognized in the accompanying consolidated statement of operations as follows (in thousands):
+Added: Executive termination benefits
+Added: Consulting and legal expenses
+Added: Other contract termination costs
+Added: Total restructuring expenses - general and administrative expenses
+Added: Employee termination benefits
+Added: Other contract termination costs
+Added: Total restructuring expenses - discontinued operations
+Added: At December 31, 2022, $ 9.3 million related to restructuring costs was included in accrued expenses and other current liabilities and $ 6.2 million was included in current liabilities of discontinued operations in the accompanying consolidated balance sheets.
+Added: Reclassification of prior year presentation
+Added: Certain prior year amounts have been reclassified for consistency with the current year presentation.
+Added: An adjustment has been made to the consolidated statements of operations for 2022 and 2021 to reclassify commercial operations and vitaCare operations to discontinued operations as both components, in the aggregate, represented a business shift that will have a major effect on the Company’s operations and financial results.
+Added: Discontinued Operations
+Added: We changed our business in 2022, by out-licensing our products to receive royalties and future sales related milestone payments, after granting an exclusive license to commercialize the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands in the United States and assigning the Company’s exclusive license to commercialize ANNOVERA to Mayne Pharma.
+Added: This plan represented a strategic shift having a major effect on the Company's operations and financial results.
+Added: Upon the completion of the Company’s restructuring and ultimate conversion from a commercial pharmaceutical company to a licensing only company with the consummation of the Mayne Transaction, the Company classified all direct revenues, costs and expenses related to commercial operations, within income (loss) from discontinued operations, net of tax, in the consolidated statements of operations for all periods presented.
+Added: No amounts for shared general and administrative operating support expense were allocated to discontinued operations.
+Added: As required by the terms of our Financing Agreement, the proceeds from both transactions were used to fully repay our outstanding debt borrowings, and as a result interest expense and amortization of deferred financing costs as well as expense for accretion of Series A Preferred Stock and loss on extinguishment of debt are included within income (loss) from discontinued operations, net of tax (as disclosed below).
+Added: Additionally, the related assets and liabilities have been reported as assets and liabilities of discontinued operations in the Company’s consolidated balance sheet as of December 31, 2022 and 2021.
+Added: The total consideration from Mayne Pharma was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of $ 12.1 million for the acquisition of net working capital subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million for prepaid royalties in connection with the License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the License Agreement, as amended.
+Added: The Company’s es timate of net working capital at closing was determined in accordance with the Transaction Agreement which establishes the process for the determination of final net working capital.
+Added: The determination of net working capital include s significant estimates which could change materially for a period of up to two years following the Closing Date .
+Added: On March 29, 2023, the Company received Mayne Pharma’s closing net working capital calculation which differed significantly from the Company’s estimate of closing net working capital.
+Added: The Company believes that its estimate of net working capital is reasonable and intends to resolve this matter through the process outlined in the Transaction Agreement.
+Added: Given the recent receipt of Mayne Pharma’s calculation and the nature of the estimates involved , the outcome of this matter is uncertain at this point.
+Added: As a result , the Company cannot reasonably estimate a range of loss, and accordingly , the Company has not accrued any additional liability ass ociated with Mayne Pharma’s calculation.
+Added: The proceeds at closing were allocated separately to the sale of ANNOVERA and the license grant related to the other products, as the sale of ANNOVERA was accounted for under ASC 610-20, Gains and Losses from Derecognition of Nonfinancial Assets in arriving at the gain on disposal.
+Added: We recognized $ 70.0 million in revenue from transaction with Mayne Pharma, which represented license to commercialize the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products as well as present value of future minimum royalty payments (as discussed in Note 1).
+Added: The Company classified the $ 143.4 million gain on the sale of the vitaCare business and $ 62.0 gain on sale of ANNOVERA, net of transaction costs in discontinued operations.
+Added: The Company recorded a restructuring expense of $ 15.7 million, for the year ended December 31, 2022 for contract terminations, severance, and fixed asset write-downs, of which $ 6.2 million was recorded in discontinued operations.
+Added: The following table presents results of discontinued operations (in thousands):
+Added: Year ended December 31,
+Added: Product revenue, net
+Added: Cost of goods sold
+Added: Operating expenses:
+Added: Selling and marketing
+Added: General and administrative
+Added: Research and development
+Added: Restructuring charges
+Added: Total operating expenses
+Added: Loss from discontinued operations
+Added: Other (expense) income:
+Added: Gain on sale of vitaCare
+Added: Gain on ANNOVERA sale
+Added: Loss on the extinguishment of debt
+Added: Interest expense and other financing costs
+Added: Expense for accretion of Series A Preferred Stock
+Added: Other income, net
+Added: Total other income (expense), net
+Added: Loss before from income taxes
+Added: Provision for income taxes
+Added: Net income (loss) from discontinued operations
+Added: The following table presents the carrying amounts of the classes of assets and liabilities of discontinued operations as of December 31, 2022 and December 31, 2021 (in thousands):
As of December 31,
−Removed: Raw materials
−Removed: Work in process
−Removed: Finished products
−Removed: During 2021 and 2020, we recorded inventory charges of $ 1.1 million and $ 7.2 million, respectively.
−Removed: The charge recorded for 2020 was primarily a result of the impact of the COVID-19 pandemic on our business, which decreased demand for our products.
−Removed: No inventory charge was recorded for 2019.
+Added: Current assets:
+Added: Accounts receivable
Prepaid and other current assets
+Added: Total current assets
+Added: Fixed assets, net
+Added: License rights and other intangible assets, net
+Added: Current liabilities:
+Added: Accounts payable
+Added: Accrued expenses and other current liabilities
+Added: Total current liabilities
+Added: Prepaid and other current assets
Our prepaid and other current assets consisted of the following (in thousands):
10 unchanged sentences
Fixed assets, net
−Removed: We recorded depreciation expense of $ 0.8 million for 2021 and 2020, and $ 0.4 million for 2019.
+Added: We recorded depreciation expense of $ 0.6 million for 2022 and $ 0.4 million for 2021.
Licensed rights and other intangible assets
2 unchanged sentences
As of December 31, 2021
−Removed: License rights and other intangible assets
+Added: Intangible assets
subject to amortization:
−Removed: License rights
Hormone therapy drug patents
1 unchanged sentence
and pending approval
−Removed: License rights and other intangible assets
+Added: Intangible assets
subject to amortization
1 unchanged sentence
Trademarks/trade name rights
−Removed: License rights and other intangible assets, net
−Removed: We recorded amortization expense related to the exclusive license rights agreement with Population Council of $ 3.0 million for 2021 and 2020, and $ 0.8 million for 2019.
−Removed: We recorded amortization expense related to patents of $ 0.3 million for 2021 and 2020, and $ 0.2 million for 2019.
−Removed: Our license rights and other intangible assets subject to amortization is expected to be amortized as follows (in thousands):
+Added: Intangible assets, net
+Added: We recorded, in continuing operations, amortization expense related to patents of $ 0.6 million for 2022 and $ 0.3 million for 2021.We recorded amortization expense related to the exclusive license rights agreement with Population Council of $ 3.0 million for 2022 and 2021, which was reclassified to discontinued operations after we completed transaction with Mayne Pharma in December 2022, which are excluded from the table above.
+Added: Our intangible assets subject to amortization are expected to be amortized as follows (in thousands):
Year ending December 31,
We use a combination of qualitative and quantitative factors to assess licensed rights and intangible assets for impairment.
−Removed: As a result of performing these assessments, we determined that no impairment existed as of December 31, 2021, therefore, no write downs were recorded to our licensed rights and other intangible assets for 2021.
−Removed: For 2020 and 2019, we wrote off $ 1.1 million and $ 0.1 million, respectively, in costs related to patents and trademarks , which were included in general and administrative expenses in the accompanying consolidated statements of operations.
+Added: As a result of performing these assessments, we determined that no impairment existed as of December 31, 2022 or 2021, therefore, no write downs were recorded to our licensed rights and other intangible assets.
Accrued expenses and other current liabilities
2 unchanged sentences
Payroll and related costs
−Removed: Sales returns and coupons
−Removed: Selling and marketing expenses
+Added: Accrued contract termination costs
Research and development expenses
−Removed: Wholesale distributor fees
Professional fees
Operating lease liabilities
+Added: Prepaid royalty
Accrued expenses and other current liabilities
−Removed: We expense advertising costs when incurred, which amounted to $ 39.7 million, $ 35.8 million and $ 9.0 million for 2021, 2020 and 2019, respectively.
+Added: We expense advertising costs when incurred, which amounted to $ 13.2 million and $ 39.7 million for 2022 and 2021, respectively, which was reclassified to discontinued operations as a result of business shift following transaction with Mayne Pharma.
Our debt consisted of the following (in thousands):
5 unchanged sentences
Financing agreement
−Removed: We are party to a Financing Agreement with Sixth Street Specialty Lending, Inc., as administrative agent (the “Administrative Agent”), various lenders from time-to-time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors.
−Removed: In connection with the initial borrowing under the Financing Agreement, we paid, for the benefit of the lenders, a facility fee equal to 2.5 % of the initial amount borrowed and were required to pay such a facility fee in connection with subsequent borrowings under the Financing Agreement.
−Removed: Borrowings under the Financing Agreement accrue interest at either (i) 3-month LIBOR plus 7.75 %, subject to a LIBOR floor of 2.70 % or (ii) the prime rate plus 6.75 %, subject to a prime rate floor of 5.2 % as selected by us.
−Removed: As of December 31, 2021, our interest rate was 10.45 %.
−Removed: Interest on amounts borrowed under the Financing Agreement is due and payable quarterly in arrears.
−Removed: In addition, we are required to pay an annual administrative fee, and other fees and expense.
−Removed: We have the right to prepay borrowings under the Financing Agreement in whole or in part at any time, subject to a prepayment fee on the principal amount being prepaid.
+Added: We were party to a Financing Agreement with Sixth Street Specialty Lending, Inc., as administrative agent (the “Administrative Agent”), various lenders from time-to-time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors.
+Added: On December 30, 2022, we repaid all obligations under the Financing Agreement and the Financing Agreement was terminated.
The Financing Agreement was entered into in April 2019, and it provided us with up to a $ 300.0 million first lien secured term loan credit facility.
2 unchanged sentences
(ii) $ 50.0 million was drawn in February 2020 and (iii) $ 50.0 million was previously available to us in the Administrative Agent’s sole and absolute discretion either contemporaneously with the delivery of our financial statements for the quarterly period ended June 30, 2020 or at such earlier date as the Administrative Agent may have consented to.
−Removed: In the third quarter of 2020, the Administrative terminated the undrawn $ 50.0 million tranche under the Financing Agreement, therefore, such amount was no longer available to us to borrow.
+Added: In the third quarter of 2020, the Administrative Agent terminated the undrawn $ 50.0 million tranche under the Financing Agreement, therefore, such amount was no longer available to us to borrow.
+Added: In connection with the initial borrowing under the Financing Agreement, we paid, for the benefit of the lenders, a facility fee equal to 2.5 % of the initial amount borrowed and were required to pay such a facility fee in connection with subsequent borrowings under the Financing Agreement.
+Added: Borrowings under the Financing Agreement accrued interest at either (i) 3-month LIBOR plus 7.75 %, subject to a LIBOR floor of 2.70 % or (ii) the prime rate plus 6.75 %, subject to a prime rate floor of 5.2 % as selected by us.
+Added: As of December 30, 2022, our interest rate was 10.45 %.
+Added: Interest on amounts borrowed under the Financing Agreement was due and payable quarterly in arrears.
+Added: In addition, we were required to pay an annual administrative fee, and other fees and expenses.
In August 2020, we entered into Amendment No.
2 unchanged sentences
In lieu of a cash amendment fee, we issued to the Administrative Agent and the lenders under the Financing Agreement warrants to purchase an aggregate of 95,042 shares of our common stock with an exercise price of $ 79 per share and a ten-year term (the “Lender Warrants”).
−Removed: The Lender Warrants were issued pursuant to an exemption from registration under the Securities Act of 1933,
−Removed: as amended, and no registration rights were issued.
+Added: The Lender Warrants were issued pursuant to an exemption from registration under the Securities Act of 1933, as amended, and no registration rights were issued.
The estimated fair value of the Lender Warrants was $ 7.4 million and was recorded as deferred financing cost since Amendment No.
−Removed: 5 was accounted for a s a debt modification .
+Added: 5 was accounted for as a debt modification.
In November 2020, in connection with Amendment No.
6 to the Financing Agreement (“Amendment No.
−Removed: 6”), we amended the Lender Warrants to provide for an adjustment to the exercise price if we conduct certain dilutive issuances prior to December 31, 2020, or if the volume-weighted average price of our common stock for the fifteen trading days ending December 31, 2020 is lower than the then current exercise price.
+Added: 6”), we amended the Lender Warrants to provide for an adjustment to the exercise price if we conduct certain dilutive issuances prior to December 31, 2020, or if the volume-weighted average price of our common stock for the fifteen trading days ending December 31, 2020 was lower than the then current exercise price.
Also, in November 2020, we concluded an underwritten public offering of our common stock and received consideration of $ 59.5 per share, after deducting for underwriting discounts and commissions.
22 unchanged sentences
and (iv) thereafter, none, in each case subject to certain limited exceptions, including with respect to a repayment in full of the obligations under the Financing Agreement.
−Removed: Based on the contractual quarterly principal repayments in Amendment No.
−Removed: 8, as of December 31, 2021, we recorded an accrual of $ 2.2 million related to future prepayment fee obligations, of which $ 1.3 million is included in accrued expenses and other current liabilities and $ 0.9 million is included in other non-current liabilities in the accompanying consolidated balance sheets.
In March 2022, we entered into Amendment No.
9 to the Financing Agreement (“Amendment No.
−Removed: See Note 17 – Subsequent events.
−Removed: In accordance with Amendment No.
−Removed: 9, the maturity date of the Financing Agreement was amended to June 1, 2022.
−Removed: Accordingly, the entire debt balance of $ 200.0 million as of December 31, 2021 will be due and payable in June 2022.
−Removed: The Financing Agreement also includes other representations, warranties, indemnities, restrictions on the payment of dividends, and events of default that are customary for financings of this type, including an event of default relating to a change of control of the Company.
−Removed: Upon or after an event of default, the Administrative Agent and the lenders may declare all or a portion of our obligations under the Financing Agreement to be immediately due and payable and exercise other rights and remedies provided for under the Financing Agreement.
−Removed: The obligations of our company and its subsidiaries under the Financing Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a first priority perfected security interest in all existing and after acquired assets of our company and its subsidiaries.
−Removed: The obligations under the Financing Agreement will be guaranteed by each of our future direct and indirect subsidiaries, subject to certain exceptions.
−Removed: Since the inception of the Financing Agreement, we have incurred a total of $ 18.8 million in deferred financing fees related to the Financing Agreement.
−Removed: As of December 31, 2021, our unamortized deferred financing fees was $ 11.7 million, which will be entirely amortized upon the maturity of the Financing Agreement in 2022.
−Removed: Additionally, in connection with Amendment No.
−Removed: 9, we will pay financing fees of $ 30.0 million, which will be paid in kind (“PIK”) by being added to the principal balance of the Financing Agreement, and future prepayment fees were waived.
−Removed: Of the total PIK financing fees, $ 16.0 million will be waived if one of the two milestones specified in Amendment No.
−Removed: 9 is achieved.
−Removed: Debt covenants
−Removed: The Financing Agreement contains customary restrictions and covenants applicable to us that are customary for financings of this type.
−Removed: Among other requirements, prior to execution of Amendment No.
−Removed: 9 in March 2022, we were required to achieve certain minimum quarterly consolidated net revenue amounts attributable to commercial sales of our IMVEXXY, BIJUVA and ANNOVERA products.
−Removed: We were not in compliance with our covenant to achieve certain minimum quarterly product net revenue requirements for the quarterly period ended December 31, 2021 of $ 26.5 million.
−Removed: In connection with Amendment No 9, this event of default was waived by the Administrative Agent and lenders, and the minimum product net revenue requirement for the quarterly period ending March 31, 2022, which is the final quarterly reporting period, was removed.
−Removed: The Financing Agreement also required us to maintain a minimum unrestricted cash balance.
−Removed: As of December 31, 2021, our cash balance was in excess of the required minimum balance.
−Removed: However, beginning on February 7, 2022, we did not maintain the required minimum unrestricted cash balance of $ 60.0 million.
−Removed: In connection with Amendment No.
−Removed: 9, this event of default was waived by the Administrative Agent and lenders, and the required minimum unrestricted cash balance was reduced.
−Removed: Credit agreement
−Removed: In April 2019, we terminated and repaid all amounts outstanding under a Credit and Security Agreement (the “Credit Agreement”), as amended, with MidCap Financial Trust, as agent and as lender and the additional lenders party thereto using a portion of the initial tranche of borrowing under the Financing Agreement.
−Removed: The aggregate amount paid of $ 81.7 million included a prepayment fee of 4 %, a repayment fee of 4 % and other fees and expenses payable to the lenders under the Credit Agreement.
−Removed: As a result of the termination of the Credit Agreement, we recorded a $ 10.1 million loss on extinguishment of debt in 2019.
+Added: 9”) pursuant to which, among other amendments, (i) the lenders waived various Company breaches of the Financing Agreement, including breaches of the $ 60.0 million minimum cash covenant and the minimum net revenue covenants for the fourth quarter of 2021;
+Added: (ii) the Company and the lenders agreed to a reduced minimum cash covenant and to the removal of the minimum net revenue covenant for the first quarter of 2022;
+Added: (iii) the lenders waived the existing $ 60.0 million prepayment penalty under the Financing Agreement and the Company agreed to pay a paid in kind (“PIK”) amendment financing fee of $ 30.0 million, which fee was added to the principal amount of the loans under the Financing Agreement, $ 16.0 million of which fee was waivable in certain conditions;
+Added: (iv) the maturity date of the Financing Agreement was amended to June 1, 2022;
+Added: and (v) the Company agreed to pay to the Lenders as a prepayment of the loans under the Financing Agreement the first $ 120.0 million of net proceeds from the vitaCare Divestiture and all net proceeds of the vitaCare Divestiture in excess of $ 135.0 million.
+Added: Amendment No.
+Added: 9 was accounted for as an extinguishment of debt modification in accordance with U.S.
+Added: Accordingly, in March 2022, we recorded an $ 8.4 million loss on extinguishment of debt, which represented the unamortized deferred financing fees, net of previously accrued prepayment fees.
+Added: Additionally, Amendment No.
+Added: 9 PIK financing fee was recorded as deferred financing fees and was amortized over the remaining term of the Financing Agreement.
+Added: In April 2022, we utilized $ 120.0 million of net proceeds from the vitaCare Divestiture to make a prepayment of the loans under the Financing Agreement under the terms of Amendment No.
+Added: Additionally, with the prepayment on the debt, $ 16.0 million of the PIK financing fee was waived in accordance with Amendment No.
+Added: In May 2022, we entered into Amendment No.
+Added: 10 to the Financing Agreement (“Amendment No.
+Added: 10”) pursuant to which, among other amendments, (i) interest payments under the Financing Agreement were paused, such that interest on each term loan was payable in cash and in arrears (a) upon any prepayment of that term loan, whether voluntary or mandatory, to the extent accrued on the amount being prepaid and (b) on the maturity date, (ii) the minimum cash covenant was set at $ 10.0 million, (iii) the maturity date of the Financing Agreement was amended to July 13, 2022 , (iv) the termination of the Company’s merger agreement with an affiliate of EW Healthcare Partners was added as an event of default, and (v) we agreed to a PIK financing fee of $ 1.8 million, which fee was added to the principal amount of the loans under the Financing Agreement.
+Added: Amendment No.
+Added: 10 was accounted for as a debt amendment in accordance with U.S.
+Added: Accordingly, in May 2022, Amendment No.
+Added: 10 PIK financing fee was recorded as deferred financing fees and was amortized over the remaining term of the Financing Agreement.
+Added: Also in May 2022, we entered into Amendment No.
+Added: 11 (“Amendment No.
+Added: 11”) to the Financing Agreement.
+Added: Amendment No.
+Added: 11 contains amendments to the Financing Agreement that would have gone into effect upon the satisfaction of certain conditions on or before July 13, 2022 (the “Amendment Effective Date”), including (i) the consummation of the merger with an affiliate of EW Healthcare Partners (the “Merger”), (ii) the payment in cash of (a) all accrued and unpaid interest under the Financing Agreement through and including the Amendment Effective Date and (b) all fees, costs, expenses and taxes then payable pursuant to Section 2.7 or 10.2 of the Financing Agreement, and (iii) the delivery to the administrative agent of certain customary documents with respect to the pledge of 100 % of the capital stock of the Company.
+Added: Since the consummation of the Merger did not occur, Amendment No.
+Added: 11 never became effective.
+Added: On July 13, 2022, we entered into Amendment No.
+Added: 12 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to July 24, 2022 , and we agreed to pay the Lenders a PIK amendment fee in the amount of $ 1.2 million.
+Added: On July 24, 2022, we entered into Amendment No.
+Added: 13 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to July 27, 2022 , we agreed to pay the Lenders a payment of accrued and unpaid interest of $ 2.9 million, and we agreed to retain Jeffrey Varsalone from G2 Capital Advisors as our chief restructuring officer.
+Added: On July 27, 2022, we entered into Amendment No.
+Added: 14 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to July 28, 2022 .
+Added: On July 28, 2022, we entered into Amendment No.
+Added: 15 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to July 29, 2022 .
+Added: On July 29, 2022, we entered into Amendment No.
+Added: 16 to the Financing Agreement pursuant to which the maturity date of the Financing Agreement was extended to September 30, 2022, with the option for us to further extend the maturity date to October 31, 2022, and November 30, 2022, in each case if we receive not less than $ 7.0 million in cash proceeds from an equity issuance, which, if preferred equity, is on substantially the same terms as the Preferred Stock.
+Added: In lieu of a cash amendment fee, to induce the Lenders to enter into Amendment No.
+Added: 16, on July 29, 2022, we issued Lender Warrants to purchase an aggregate of 185,000 shares of Common Stock, pursuant to a subscription agreement by and among the Company and the Lenders (the “July Lender Subscription Agreement”).
+Added: The Lender Warrants to purchase 185,000 shares of our Common Stock issued pursuant to the July Lender Subscription Agreement have an exercise price of $ 0.01 per warrant, subject to certain adjustment as provided therein, and an expiration date of July 29, 2032, and may be exercised via cashless exercise pursuant to the terms thereof.
+Added: These Lender Warrants were initially valued at $ 1.2 million based on the market price of our Common Stock on July 29, 2022 and entirely expensed as financing costs.
+Added: In connection with the closing of a private placement offering with Rubric Capital Management LP (“the Preferred Stock Investor”) on September 30, 2022, and in accordance with Amendment No.
+Added: 16 to the Financing Agreement, on September 30, 2022, we issued Lender Warrants to purchase an aggregate of 125,000 shares of Common Stock, pursuant to a subscription agreement by and among the Company and the Lenders (the “September Lender Subscription Agreement”), and the maturity date of the Financing Agreement was extended to October 31, 2022.
+Added: These Lender Warrants have an exercise price of $ 0.01 per share of Common Stock, subject to certain adjustment as provided therein, and an expiration date of September 30, 2032 and may be exercised via cashless exercise pursuant to the terms thereof.
+Added: These Lender Warrants were initially valued at $ 0.8 million based on the market price of our Common Stock on September 30, 2022 and recorded as deferred financing fees, which were expensed with maturity of the Financing Agreement on October 31, 2022.
+Added: Additionally, in September 2022, we and the Lenders agreed to PIK interest of $ 2.5 million related to the outstanding debt balance.
+Added: In connection with the closing of the private placement offering with the Preferred Stock Investor on October 28, 2022, and in accordance with Amendment No.
+Added: 16 to the Financing Agreement, on October 28, 2022, we issued Lender Warrants to purchase an aggregate of 125,000 shares of Common Stock, pursuant to a subscription agreement by and among the Company and the Lenders, and the maturity date of the Financing Agreement was extended to November 30, 2022.
+Added: These Lender Warrants have an exercise price of $ 0.01 per share of Common Stock, subject to certain adjustment as provided therein, and an expiration date of October 28, 2032 and may be exercised via cashless exercise pursuant to the terms thereof.
+Added: These Lender Warrants were initially valued at $ 0.7 million based on the market price of our Common Stock on October 28, 2022 and recorded as financing costs.
+Added: The fair value of the Lender Warrants was based on the date of grant using our Common Stock’s closing price at measurement date and was recorded to “Additional paid-in-capital” in the consolidated balance sheets.
+Added: See Note 9, Mandatory Redeemable Preferred Stock and Stockholders’ Equity (Deficit) for additional information regarding the equity financing with the Preferred Stock Investor.
+Added: On November 30, 2022, we entered into Amendment No.
+Added: 17 (“Amendment No.
+Added: 17”) to the Financing Agreement.
+Added: Pursuant to Amendment No.
+Added: 17, among other things, (i) the maturity date of the Financing Agreement was extended to December 31, 2022 , subject to the achievement of certain milestones by the Company, (ii) the minimum cash covenant was set at $ 7.5 million, (iii) the Company agreed to pay the Lenders an amendment fee in the amount of $ 750,000 and (iv) the Company paid the Lenders all accrued and unpaid interest under the Financing Agreement as of the Amendment Date, in the amount of approximately $ 4.2 million.
+Added: On December 30, 2022, we repaid remaining obligations under the Financing Agreement of $ 75.0 million, PIK financing fees of $ 17.0 million and the remaining accrued interest, and the Financing Agreement was terminated.
Interest and financing costs
3 unchanged sentences
Financing fees amortization
−Removed: Interest expense and other financing costs
Commitments and contingencies
2 unchanged sentences
The lease includes 56,212 rentable square feet, or the full premises, of which the lease on 7,561 square feet commenced in 2018 and the lease on the remaining 48,651 square feet commenced in August 2019, or the full premises commencement date.
−Removed: The lease will expire 11 years after the full premises commencement date, unless terminated earlier in accordance with the terms of the lease.
+Added: The lease will expire 11 years after the full premises commencement date, unless
+Added: terminated earlier in accordance with the terms of the lease.
We have the option to extend the term of the lease for two additional consecutive periods of five years .
3 unchanged sentences
In June 2019, we entered into an agreement with the same lessors to lease additional 6,536 square feet of administrative office space in the same location, pursuant to an addendum to such lease, which commenced in May 2020.
+Added: We are in the process of subleasing our headquarters as a result of shifting our business to become a license company and terminating our employees.
+Added: We anticipate that sublease income will approximate the amounts due under our existing leases, therefore no impairment of the right of use asset was recorded in 2022.
For 2022, operating lease expense related to our real estate leases was $ 1.4 million and variable lease expense was $ 0.7 million.
For 2021, operating lease expense related to our real estate leases was $ 2.1 million and variable lease expense was $ 0.7 million.
−Removed: For 2019, operating lease expense related to our real estate leases was $ 1.6 million and variable lease expense was insignificant.
+Added: In 2022, our rental income was $ 0.4 million on sublease of our two suites which were subleased following vitaCare transaction.
As of December 31, 2022, our remaining lease payments were as follows (in thousands):
17 unchanged sentences
lease obligations (non-cash in thousands)
+Added: Mayne Pharma Agreement
+Added: Mayne Pharma paid us approximately $ 12.1 million at closing for the acquisition of net working capital, as determined in accordance with the Transaction Agreement, and is subject to certain adjustments for a period of up to two years following the Closing Date.
+Added: Pursuant to the Mayne License Agreement Amendment, Mayne Pharma also paid the Company approximately $ 1.0 million in prepaid royalties on the Closing Date.
+Added: The prepaid royalties will reduce the first four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $ 257,250 per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such quarterly royalty payment is paid to the Company.
+Added: Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to the Company by $ 1.5 million in consideration of Mayne Pharma assuming the Company’s obligations under a long-term services agreement, including the Company’s minimum payment obligations thereunder.
Population Council license agreement
Under the terms of the Population Council License Agreement, we paid the Population Council a milestone payment of $ 20.0 million in 2018, which was within 30 days following the approval by the FDA of the NDA for ANNOVERA, and $ 20.0 million in 2019 following the first commercial batch release of ANNOVERA.
−Removed: The aggregate $ 40.0 million of milestone payments were recorded as license rights, see “Note 6.
−Removed: License rights and other intangible assets” for additional information.
−Removed: The Population Council is also eligible to receive future payments upon the achievement of certain commercial sales milestones of ANNOVERA.
−Removed: We are required to pay the Population Council additional milestone payments of $ 40.0 million upon cumulative net sales of ANNOVERA in the U.S.
−Removed: by us and our affiliated and permitted sublicensees of each of $ 200.0 million, $ 400.0 million and $ 1.0 billion.
−Removed: We will record any future milestone payment as incremental license rights cost when incurred, and amortize such costs over the remaining useful life over which the license rights will contribute directly or indirectly to our cash flows based on when ANNOVERA became commercially available for use.
−Removed: Accordingly, if and when we incur the incremental license rights cost, we will immediately record an additional amortization amount that assumed the incremental cost was incurred when the first commercial batch of ANNOVERA was released in 2019.
−Removed: The Population Council has agreed to perform and pay the costs and expenses associated with four post-approval studies required by the FDA for ANNOVERA, and we have agreed to perform and pay the costs and expenses associated with a post approval study required by the FDA to measure risk for venous thromboembolism, provided that if the costs and expenses associated with such post-approval study exceed $ 20.0 million, half of such excess will be offset against royalties or other payments owed by us to the Population Council under the Population Council License Agreement.
−Removed: To the extent that the Population Council does not fulfil these studies to FDA’s satisfaction, FDA may impose additional requirements and penalties against us, as we hold the NDA for ANNOVERA.
+Added: The aggregate $ 40.0 million of milestone payments were recorded as license rights.
+Added: The Population Council was also eligible to receive future payments upon the achievement of certain commercial sales milestones of ANNOVERA.
+Added: On December 30, 3022, we assigned the ANNOVERA license to Mayne Pharma.
+Added: The rights and obligations under the Population Council License Agreement have been transferred to Mayne Pharma and will revert back to us upon certain events.
+Added: The Population Council has agreed to perform and pay the costs and expenses associated with four post-approval studies required by the FDA for ANNOVERA, and we had agreed to perform and pay the costs and expenses associated with a post approval study required by the FDA to measure risk for venous thromboembolism, provided that if the costs and expenses associated with such post-approval study exceed $ 20.0 million, half of such excess was to be offset against royalties or other payments owed by us to the Population Council under the Population Council License Agreement.
In July 2021, we received a letter from FDA indicating that the post-marketing commitment study being conducted by the Population Council for ANNOVERA to characterize the in vivo release rate of ANNOVERA was not fulfilled to FDA’s satisfaction.
−Removed: In addition, the final reports
−Removed: for the two post-marketing requirement studies being performed by the Population Council for ANNOVERA were not submitted by the initial listed submission deadline, which deadlines have since been extended by FDA.
−Removed: We are working with Population Council to complete the post-marketing commitment study to FDA’s satisfaction and reduce the delay in submitting the post-marketing requirement final reports.
−Removed: To the extent that the Population Council does not fulfil these studies to FDA’s satisfaction, FDA may impose additional requirements and penalties against us, as we hold the NDA for ANNOVERA.
−Removed: We and the Population Council have agreed to form a joint product committee responsible for overseeing activities under the Population Council License Agreement.
−Removed: We are responsible for all aspects of marketing, promotion, product positioning, pricing, education programs, publications, sales messages and any additional desired clinical studies for the one-year vaginal contraceptive system, subject to oversight and decisions made by the joint product committee.
−Removed: We are also required to pay the Population Council, on a quarterly basis, step-based royalty payments based on our annual net sales of ANNOVERA as follows:
−Removed: (i) if annual net sales are less than or equal to $ 50.0 million, a royalty of 5 % of net sales;
−Removed: (ii) for annual net sales greater than $ 50.0 million and less than or equal to $ 150.0 million, a royalty of 10 % of such net sales;
−Removed: and (iii) for net sales greater than $ 150.0 , a royalty of 15 % of such net sales.
−Removed: The annual royalty rate will be reduced to 50 % of the initial rate during the six-month period beginning on the date of the first arms-length commercial sale of a generic equivalent of the one-year vaginal contraceptive system that is launched by a third-party in the U.S., and thereafter will be reduced to 20 % of the initial rate.
+Added: In addition, the final reports for the two post-marketing requirement studies being performed by the Population Council for ANNOVERA were not submitted by the initial listed submission deadline, which deadlines have since been extended by FDA.
+Added: Our obligations to perform the post-approval study have been transferred to Mayne Pharma as part of the Mayne License Agreement.
+Added: We believe that Mayne Pharma is working with Population Council to complete the post-marketing commitment study to FDA’s satisfaction and reduce the delay in submitting the post-marketing requirement final reports.
+Added: To the extent that the Population Council does not fulfil these studies to FDA’s satisfaction, FDA may impose additional requirements and penalties against the NDA holder for ANNOVERA.
Unless earlier terminated, the Population Council License Agreement will remain in effect until the later of the expiration of the last-to-expire of the Population Council’s U.S.
−Removed: patents that are licensed to us, or the date following such expiration that follows a continuous period of six months during which we and our affiliates have not made a commercial sale of ANNOVERA in the U.S.
−Removed: The Population Council License Agreement may also be terminated for certain breach and bankruptcy-related events and by us on 180 days’ prior notice to the Population Council.
+Added: patents that are licensed to Mayne Pharma, or the date following such expiration that follows a continuous period of six months during which Mayne Pharma has not made a commercial sale of ANNOVERA in the U.S.
+Added: The Population Council License Agreement may also be terminated for certain breach and bankruptcy-related events and by Mayne Pharma on 180 days’ prior notice to the Population Council.
Purchase commitments
−Removed: We have manufacturing and supply agreements whereby we are required to purchase from Catalent, Inc.
+Added: We had manufacturing and supply agreements whereby we were required to purchase from Catalent, Inc.
(“Catalent”) a minimum number of units of BIJUVA and IMVEXXY softgels during each respective annual contract year.
−Removed: The annual contract period for BIJUVA and IMVEXXY ends each April and July, respectively.
−Removed: If the minimum order quantities of BIJUVA or IMVEXXY are not met, we are required to pay a minimum commitment fee equal to 50 % or 60 %, respectively, of the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of BIJUVA or IMVEXXY during each product’s respective contract year.
−Removed: Our estimated minimum commitments for Catalent are as follows:
−Removed: $ 5.2 million for 2022, $ 3.9 million for 2023, $ 4.3 million for 2024, $ 4.7 million for 2025, $ 4.8 million for 2026, and $ 11.5 million thereafter.
−Removed: Additionally, with another third-party manufacturer, we have a manufacturing and supply agreement, renewable annually, whereby we are required to purchase a minimum number of units of ANNOVERA during a contract year.
−Removed: The annual contract period for ANNOVERA ends each August.
−Removed: If the minimum order quantities of ANNOVERA are not met, we are required to pay a minimum commitment fee equal to the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of ANNOVERA during the contract year.
−Removed: Our estimated minimum commitment for ANNOVERA is $ 2.1 million for 2022.
−Removed: For each of the three annual contract years ending in 2021, we have met our minimum purchase number of units in all material respects.
−Removed: For annual contract years ending in 2022 and thereafter, we will continue to evaluate whether we will be able to meet each annual contract year’s respective minimum purchase commitment and will record a liability for estimated minimum commitment fees if we believe that we will not be able to reasonably meet the minimum purchase commitment.
−Removed: We believe that minimum commitment fees that we may pay, if any, will not have a material impact to our financial position and operating results.
+Added: The annual contract period for BIJUVA and IMVEXXY ended each April and July, respectively.
+Added: If the minimum order quantities of BIJUVA or IMVEXXY were not met, we were required to pay a minimum commitment fee equal to 50 % or 60 %, respectively, of the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of BIJUVA or IMVEXXY during each product’s respective contract year.
+Added: Additionally, with another third-party manufacturer, we had a manufacturing and supply agreement, renewable annually, whereby we were required to purchase a minimum number of units of ANNOVERA during a contract year.
+Added: The annual contract period for ANNOVERA ended each August.
+Added: If the minimum order quantities of ANNOVERA were not met, we were required to pay a minimum commitment fee equal to the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of ANNOVERA during the contract year.
+Added: On December 30, 2022, after granting an exclusive license to commercialize the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands and assigning the Company’s exclusive license to commercialize ANNOVERA to Mayne Pharma, the rights and obligations under the Catalent minimum manufacturing and supply agreements and other supply agreements have been transferred to Mayne Pharma.
Legal proceedings
−Removed: In February 2020, we received a Paragraph IV certification notice letter (the “IMVEXXY Notice Letter”) regarding an Abbreviated New Drug Application (“ANDA”) submitted to FDA by Teva Pharmaceuticals USA, Inc.
−Removed: The ANDA seeks approval from FDA to commercially manufacture, use, or sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY.
−Removed: In the IMVEXXY Notice Letter, Teva alleges that TherapeuticsMD patents listed in FDA’s Orange Book that claim compositions and methods of IMVEXXY (the “IMVEXXY Patents”), are invalid, unenforceable, and/or will not be infringed by Teva’s commercial manufacture, use, or sale of its proposed generic drug product.
+Added: In February 2020, we received a Paragraph IV certification notice letter (the “IMVEXXY Notice Letter”) regarding an Abbreviated New Drug Application (“ANDA”) submitted to the FDA by Teva Pharmaceuticals USA, Inc.
+Added: The ANDA seeks approval from the FDA to commercially manufacture, use, or sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY.
+Added: In the IMVEXXY
+Added: Notice Letter, Teva alleges that TherapeuticsMD patents listed in the FDA’s Orange Book that claim compositions and methods of IMVEXXY (the “IMVEXXY Patents”) are invalid, unenforceable, and/or will not be infringed by Teva’s commercial manufacture, use, or sale of its proposed generic drug product.
The IMVEXXY Patents identified in the IMVEXXY Notice Letter expire in 2032 or 2033.
3 unchanged sentences
In July 2021, following a proposal by Teva, the District Court entered an order temporarily staying all proceedings in the IMVEXXY litigation, which order was filed under seal.
−Removed: In September 2021, the District Court made available a public version of the
−Removed: order following the parties’ agreement to a consent motion to redact information Teva contended was confidential.
−Removed: The order provides that the statutory stay that prevents FDA from granting final approval of the ANDA for 30 months from the date of the Notice Letter will be extended for the number of days that the stay of the IMVEXXY litigation is in place.
+Added: In September 2021, the District Court made available a public version of the order following the parties’ agreement to a consent motion to redact information Teva contended was confidential.
+Added: The order provides that the statutory stay that prevents the FDA from granting final approval of the ANDA for 30 months from the date of the IMVEXXY Notice Letter will be extended for the number of days that the stay of the IMVEXXY litigation is in place.
The length of the stay of the IMVEXXY litigation is dependent on further action by Teva.
+Added: As of December 31 , 2022, for the IMVEXXY Paragraph IV legal proceeding, we have incurred and recorded legal costs amounting to $ 2.3 million in prepaid expenses and other current assets since we believe that we will successfully prevail in this legal proceeding.
+Added: Upon the successful conclusion of the legal proceeding, the related capitalized legal costs will be reclassified to patents, in license rights and other intangible assets, net, in the accompanying consolidated balance sheets, and such costs will be amortized over the remaining useful life of the patents.
+Added: If we are unsuccessful in this legal proceeding, then the related capitalized legal costs for this legal preceding and any unamortized IMVEXXY patent costs that were previously capitalized will be immediately expensed in the period in which we become aware of an unsuccessful legal proceeding.
In March 2020, we received a Paragraph IV certification notice letter (the “BIJUVA Notice Letter”) regarding an ANDA submitted to FDA by Amneal Pharmaceuticals (“Amneal”).
4 unchanged sentences
commencing in May 2032 (180 days before the current expiration date in November 2032 for the last to expire of our BIJUVA Patents), or earlier under certain circumstances customary for settlement agreements of this nature.
−Removed: As of December 31, 2021, for the IMVEXXY paragraph IV legal proceeding, we have incurred and recorded legal costs amounting to $ 2.3 million in prepaid expenses and other current assets since we believe that we will successfully prevail in this legal proceeding.
−Removed: Upon the successful conclusion of the legal proceeding, the related capitalized legal costs will be reclassified to patents, in license rights and other intangible assets, net, in the accompanying consolidated balance sheets, and such costs will be amortized over the remaining useful of the patent.
−Removed: If we are unsuccessful in this legal proceeding, then the related capitalized legal costs for this legal preceding and any unamortized IMVEXXY patent costs that were previously capitalized will be immediately expensed in the period in which we become aware of unsuccessful legal proceeding.
+Added: As of December 30, 2022 and per the license agreement, Mayne Pharma is responsible for all enforcement of our patents, including this litigation with Teva.
From time to time, we are involved in other litigations and proceedings in the ordinary course of business.
We are currently not involved in any other litigations and proceedings that we believe would have a material effect on our consolidated financial condition, results of operations, or cash flows.
+Added: Compliance with Nasdaq’s continued listing requirements
+Added: In January 2023, we received a deficiency letter (the “Notice”) from the Listing Qualifications Department of the Nasdaq Stock Market, LLC (“Nasdaq”) notifying us that we were not in compliance with the rules for continued listing as set forth in Nasdaq Listing Rule 5620(a) (the “Annual Meeting Rule”) due to our failure to hold an annual meeting of stockholders within 12 months after our fiscal year ended December 31, 2021.
+Added: The Notice had no immediate effect on the listing of our Common Stock.
+Added: We did not hold an annual meeting of stockholders during 2022 due to our then ongoing strategic processes.
+Added: The Notice stated that, under Nasdaq Listing Rule 5810(c)(2)(G), we had 45 calendar days, or until February 20, 2023, to submit a plan to regain compliance with the Annual Meeting Rule.
+Added: We timely submitted such plan, and Nasdaq granted us an extension until June 29, 2023, to regain compliance.
+Added: It is our intent to hold an annual meeting of stockholders in 2023 prior to such deadline and to fully regain compliance with all applicable Nasdaq listing standards.
Off-balance sheet arrangements
1 unchanged sentence
Employment agreements
−Removed: We have entered into employment agreements with certain of our executives that provide for compensation and certain other benefits.
−Removed: Under certain circumstances, including a change in control, some of these agreements provide for severance or other payments, if those circumstances occur during the term of the employment agreement.
+Added: In connection with the Company’s transformation into a pharmaceutical royalty company, the termination of our executive management team (except for Mr.
+Added: Marlan Walker, our former General Counsel and current Chief Executive Officer) and all other employees was completed by December 31, 2022.
+Added: Severance obligations for all employees other than executive officers were paid in full in the first quarter of 2023 and severance obligations for terminated executive officers will be paid in accordance with their employment agreements and separation agreements as previously disclosed.
+Added: As of December 31, 2022, we have employed one full-time employee primarily engaged in executive position.
+Added: We have engaged external consultants, including certain former members of our management team, who support our relationship with current partners and assist with certain financial, legal and regulatory matters and the continued wind-down of our historical business operations.
+Added: The separation of our former Interim Co-Chief Executive Officers, former Interim Chief Financial Officer and other executives from the Company was a termination without “Good Cause,” as defined in their employment agreements.
+Added: In the aggregate, in December 2022, we recorded severance expenses for executive termination obligations of $ 6.0 million, of which $ 1.1 million was related to share-based compensation recorded in connection with accelerated vesting of certain share-based payment awards.
+Added: On September 6, 2022, our Board appointed interim Co-Chief Executive Officers.
+Added: The separation of our former chief executive officer from the Company was a termination without “Good Cause,” as defined in his employment agreement.
+Added: Accordingly, our former chief executive officer received the separation benefits provided therein, and we recorded executive officer severance expenses of $ 4.8 million, of which $ 3.2 million was related to share-based compensation recorded in connection with accelerated vesting of certain share-based payment awards for the former chief executive officer.
+Added: In connection with our former chief executive officer’s separation from the Company, he ceased to serve as a member of our Board.
In September 2021, our former Executive Vice President of Operations (“EVP of Operations”) and us mutually agreed that the EVP of Operations would separate from the company.
1 unchanged sentence
accordingly, he received the separation benefits provided therein.
−Removed: Then, i n December 2021, our Board of Directors (the “Board”) appointed our current Chief Executive Officer (“CEO”).
+Added: Then, i n December 2021, our Board of Directors (the “Board”) appointed a new Chief Executive Officer (“CEO”).
Our former CEO’s separation as CEO was a termination without “Cause,” as defined in his employment agreement.
3 unchanged sentences
Employee benefit plan
−Removed: We maintain a voluntary defined contribution 401(k) plan covering all eligible employees as defined in the plan documents.
−Removed: The plan provides for discretionary matching contribution, which is equal to up to four percent of each eligible contributing participant’s elective deferral not to exceed two thousand per year.
−Removed: Employees who elect to participate in the plan are generally fully vested in any existing
−Removed: matching contribution after five years of service with the Company.
−Removed: Contributions by the Company under the plan amounted to $ 0.6 million for 2021, and $ 0.5 million for each of 2020 and 2019.
−Removed: Stockholders’ deficit
+Added: We maintained a voluntary defined contribution 401(k) plan covering all eligible employees as defined in the plan documents.
+Added: The plan provided for discretionary matching contribution, which is equal to up to four percent of each eligible contributing participant’s elective deferral not to exceed two thousand per year.
+Added: Employees who elected to participate in the plan were generally fully vested in any existing matching contribution after five years of service with the Company.
+Added: As part of termination of employees, all contributions made by the Company to each participant became 100 % vested.
+Added: Contributions by the Company under the plan amounted to $ 0.5 million and $ 0.6 million for 2022 and 2021, respectively.
+Added: Mandatory Redeemable Preferred Stock and Stockholders’ Equity (Deficit)
+Added: Rubric Capital Management LP Subscription Agreements (Sale of Mandatory Redeemable Preferred Stock and Common Stock)
+Added: On July 29, 2022, we entered into a Subscription Agreement with the Preferred Stock Investor, pursuant to which we issued and sold, in a private placement offering, (i) 15,000 shares of the Company’s newly- designated Series A Preferred Stock, par value $ 0.001 per share (the “Series A Preferred Stock”) for a purchase price per share of Series A Preferred Stock equal to $ 822.21 and an aggregate purchase price of $ 12.3 million, and (ii) 565,000 shares of the Company’s Common Stock, for a purchase price per share of Common Stock equal to $ 4.72 and an aggregate purchase price of $ 2.7 million.
+Added: This offering closed on July 29, 2022, and we received aggregate gross proceeds of $ 15.0 million, before expenses.
+Added: On September 30, 2022, we entered into a Subscription Agreement with the Preferred Stock Investor, pursuant to which we issued and sold, in a private placement offering, 7,000 shares of the Company’s Series A Preferred Stock for an aggregate offering price of $ 7.0 million.
+Added: In addition, in lieu of issuing, selling and delivering 263,666 shares of the Company’s Common Stock to the Preferred Stock Investor, we agreed to pay the Preferred Stock Investor, on the later of (i) the Maturity Date (as defined in the Certificate of Designation, Preferences and Rights of Series A Preferred Stock, establishing the powers, designations, preferences and privileges and the
+Added: qualifications, limitations or restrictions of the Series A Preferred Stock (the “Certificate of Designation”)) or (ii) the date our obligations under the Financing Agreement were paid in full, a make-whole payment equal to 263,666 multiplied by the closing price of our Common Stock on the principal securities exchange or securities market on which the Common Stock is then traded, on the day prior to the date of payment of the make-whole payment.
+Added: This offering closed on September 30, 2022, and we received gross proceeds of $ 7.0 million, before expenses.
+Added: On October 28, 2022, we entered into a Subscription Agreement with the Preferred Stock Investor, pursuant to which we issued and sold, in a private placement offering, 7,000 shares of the Company’s Series A Preferred Stock for an aggregate offering price of $ 7.0 million.
+Added: In addition, in lieu of issuing, selling and delivering 263,666 shares of the Company’s Common Stock to the Preferred Stock Investor, we agreed to pay the Preferred Stock Investor, on the later of (i) Maturity Date or (ii) the date our obligations under the Financing Agreement were paid in full, a make-whole payment equal to 263,666 multiplied by the closing price of our Common Stock on the principal securities exchange or securities market on which the Common Stock is then traded, on the day prior to the date of payment of the make-whole payment.
+Added: This offering closed on October 28, 2022, and we received gross proceeds of $ 7.0 million, before expenses.
+Added: The Company received gross proceeds of $ 7 million from the Offering, before expenses.
+Added: The Series A Preferred Stock was not convertible into Common Stock and ranked senior to Common Stock, with respect to rights on the distribution of assets on any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company.
+Added: In the event of any voluntary or involuntary liquidation, dissolution or winding up of the affairs of the Company, the Series A Preferred Stock had a liquidation preference equal to $ 1,333 per share.
+Added: The Series A Preferred Stock did not have any voting rights other than as required by applicable law.
+Added: The holders of Series A Preferred Stock were entitled to dividends equal to 25 % of cash dividends actually paid, if any, on shares of Common Stock, paid pro rata on the outstanding shares of Series A Preferred Stock.
+Added: Upon the occurrence of change of control, the holders of Series A Preferred Stock could have required the Company to redeem all or part of such holder’s Series A Preferred Stock at a redemption price per share of Series A Preferred Stock, payable in cash, equal to the liquidation preference of $ 1,333 per share of Series A Preferred Stock.
+Added: We also had the option to redeem all the outstanding shares of Series A Preferred Stock on such terms if we consummated a change of control transaction.
+Added: Each holder of Series A Preferred Stock also had the right to cause the Company to redeem all, but not less than all, of their shares of the Series A Preferred Stock upon the occurrence of certain events, including, without limitation, the Company’s failure to comply with any covenants under the Certificate of Designation or if the Company commenced a bankruptcy proceeding, subject to certain conditions.
+Added: Under such circumstances, the Company was required to redeem all, but not less than all, of the holder’s outstanding shares of Series A Preferred Stock at a redemption price per share of Series A Preferred Stock, payable in cash, equal to the liquidation preference of $ 1,333 per share.
+Added: We were required to redeem from each holder of Series A Preferred Stock all outstanding shares of Series A Preferred Stock held by such holder, at a redemption price per share of Series A Preferred Stock, payable in cash, equal to the liquidation preference of $ 1,333 per share of Series A Preferred Stock, upon the earlier to occur of (i) the Maturity Date and (ii) the incurrence of Permitted Refinancing Indebtedness (as defined in the Certificate of Designation).
+Added: The Company accreted the Series A Preferred Stock from its fair value on the date of issuance to its redemption value using the effective interest rate method.
+Added: On December 30, 2022, and in accordance with the terms of the Certificate of Designation, the Company mandatorily redeemed all 29,000 outstanding shares of Series A Preferred Stock at a purchase price of $ 1,333 per share.
+Added: The Company also paid certain affiliates of the Preferred Stock Investor approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously entered into between the Company and the Preferred Stock Investor.
In March 2021, we entered into an at-the-market equity offering program (the “2021 ATM Program”) relating to shares of our common stock.
−Removed: The 2021 ATM Program permits us to offer and sell shares of our common stock having an aggregate offering price of up to $ 100.0 million from time to time through or to the sales agent under the 2021 ATM Program.
−Removed: Sales of our common stock may be made from time to time in at-the-market offerings as defined in Rule 415 of the Securities Act, including by means of ordinary broker’s transactions on The Nasdaq Stock Market LLC (“Nasdaq”) or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices, or as otherwise agreed to with the sales agent.
−Removed: The sales agent will be entitled to compensation at a fixed commission rate of 3.0 % of the aggregate gross sales price per share sold.
−Removed: The sales agent is not required to sell any specific number or dollar amounts of securities but will act as sales agent and use commercially reasonable efforts to sell on our behalf all the shares of common stock requested to be sold by us, consistent with its normal trading and sales practices, on mutually agreed terms between us and the sales agent.
−Removed: Through December 31, 2021, we have sold a total of 33,705,315 shares of our common stock under the 2021 ATM Program at an average sale price of $ 1.21 per share and we received estimated net proceeds of $ 39.4 million, after deducting discounts and commissions to the sales agent and estimated offering expenses.
+Added: The 2021 ATM Program permitted us to offer and sell shares of our common stock having an aggregate offering price of up to $ 100.0 million from time to time through or to the sales agent under the 2021 ATM Program.
+Added: Sales of our common stock could be made from time to time in at-the-market offerings as defined in Rule 415 of the Securities Act, including by means of ordinary broker’s transactions on The Nasdaq Stock Market LLC (“Nasdaq”) or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices, or as otherwise agreed to with the sales agent.
+Added: The sales agent was entitled to compensation at a fixed commission rate of 3.0 % of the aggregate gross sales price per share sold.
+Added: The sales agent was not required to sell any specific number or dollar amounts of securities but acted as sales agent and used commercially reasonable efforts to sell on our behalf all the shares of common stock requested to be sold by us, consistent with its normal trading and sales practices, on mutually agreed terms between us and the sales agent.
+Added: Through December 31, 2021, we sold a total of 674,106 shares of our common stock under the 2021 ATM Program at an average sale price of $ 60.5 per share and we received estimated net proceeds of $ 39.4 million, after deducting discounts and commissions to the sales agent and estimated offering expenses.
Subsequently, through the date of this 2022 10-K Report, we have not sold any additional shares of our common stock under the 2021 ATM Program .
+Added: The Company does not currently have an effective shelf registration statement in place and therefore, the 2021 ATM program has been suspended.
Future sales, if any, under the 2021 ATM Program will depend on a variety of factors, including among others, market conditions, the trading price of our common stock, determinations by us of the appropriate sources of funding, and potential uses of funding available to us.
In February 2021, we closed on an underwritten public offering of our common stock, pursuant to which we issued 1,189,189 shares of our common stock at an offering price of $ 92.5 per share, and we received net proceeds of $ 96.6 million, after deducting the underwriting discounts and commissions and estimated offering expenses.
−Removed: In November 2020, we entered into an at-the-market offering program (the “2020 ATM Program”) relating to shares of our common stock.
−Removed: The 2020 ATM Program permitted us to offer and sell shares of our common stock having an aggregate offering price of up to $ 50.0 million from time to time through or to the sales agent under the 2020 ATM Program.
−Removed: Sales of our common stock were permitted to be made from time to time in at-the-market offerings as defined in Rule 415 of the Securities Act of 1933, as amended (the “Securities Act”), including by means of ordinary broker’s transactions on Nasdaq or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices, or as otherwise agreed to with the sales agent.
−Removed: The sales agent was entitled to compensation at a fixed commission rate of 3.0 % of the aggregate gross sales price per share sold.
−Removed: As of February 8, 2021, sales of shares of our common stock under the 2020 ATM Program were completed when we sold an aggregate total of 28,600,689 shares of our common stock at an average sale price of $ 1.75 per share.
−Removed: For the 2020 ATM Program, we received net proceeds of $ 48.1 million, after deducting the discounts and commissions to the sales agent and estimated offering expenses .
−Removed: Also, in November 2020, we closed on an underwritten public offering of our common stock, pursuant to which we issued 26,953,125 shares of our common stock, which includes 3,515,625 shares issued for the exercise of an underwriter option, at an offering price of $ 1.28 per share, and we received net proceeds of $ 31.7 million, after deducting the underwriting discounts and commissions and estimated offering expenses.
−Removed: Also, in October 2019, we closed on an underwritten public offering of our common stock, pursuant to which we issued 29,900,000 shares of our common stock, which includes 3,900,000 shares issued for the exercise of an underwriter option, at an offering price of $ 2.75 per share, and we received net proceeds of $ 77.0 million, after deducting the underwriting discounts and commissions and estimated offering expenses.
As disclosed in Note 7.
−Removed: Debt”, in 2020, we issued to the Administrative Agent and the lenders under the Financing Agreement warrants to purchase an aggregate of 4,752,116 shares of our common stock.
−Removed: In 2019, we granted warrants to purchase an aggregate of 75,000 shares of our common stock to outside consultants.
+Added: Debt, in 2022 we issued to the Administrative Agent and the lenders under the Financing Agreement Lender Warrants to purchase an aggregate of 435,000 shares of common stock in relation to Amendment No.16 to the Financing Agreement.
+Added: In 2020, we issued to the Administrative Agent and the lenders under the Financing Agreement warrants to purchase an aggregate of 95,042 shares of our common stock.
The following table summarizes the status of our outstanding and exercisable warrants and related for each of the following years (in thousands, except weighed average exercise price and weighted average remaining contractual life data):
Warrants outstanding and exercisable
−Removed: Balance, January 1, 2019
−Removed: Issued/granted
Balance, December 31, 2020
−Removed: Issued/granted
−Removed: Cancelled/Forfeited
Balance, December 31, 2021
3 unchanged sentences
expected term of 10 years, volatility of 69.4 %, dividend yields of 0 % and risk-free interest rates of 2.9 %.
−Removed: The weighted average fair value of the warrants granted in 2019 was $ 3.00 per warrant and the assumptions used to determine such fair value were as follows:
−Removed: expected term of 5 years, volatility of 60.8 %, dividend yields of 0 % and risk-free interest rates of 2.5 %.
+Added: The fair value of the Lender Warrants was based on the date of grant using our Common Stock’s closing price at measurement date and was recorded to “Additional paid-in-capital” in the consolidated balance sheets.
+Added: There were no warrant grants in 2021.
Share-based payment award plans
12 unchanged sentences
Under the 2019 Plan, 749,500 shares of common stock are authorized for issuance, which includes 449,500 shares from the First Amendment to the 2019 Plan, which was approved by our stockholders in May 2021 plus any unallocated shares previously available for issuance under the Prior Plans that were not then subject to outstanding awards.
−Removed: Any shares subject to outstanding share-based payment awards under the 2019 Plan and Prior Plans that are forfeited, expire or otherwise terminate without issuance of the underlying
−Removed: shares, or if any such award is settled for cash or otherwise does not result in the issuance of all or a portion of the shares subject to such award (other than shares tendered or withheld in connection with the exercise of an award or the satisfaction of withholding tax liabilities), the shares to which those awards were subject, shall, to the extent of such forfeiture, expiration, termination, cash settlement or non-issuance, again be available for delivery with respect to awards under the 2019 Plan.
+Added: Any shares subject to outstanding share-based payment awards under the 2019 Plan and Prior Plans that are forfeited, expire or otherwise terminate without issuance of the underlying shares, or if any such award is settled for cash or otherwise does not result in the issuance of all or a portion of the shares subject to such award (other than shares tendered or withheld in connection with the exercise of an award or the satisfaction of withholding tax liabilities), the shares to which those awards were subject, shall, to the extent of such forfeiture, expiration, termination, cash settlement or non-issuance, again be available for delivery with respect to awards under the 2019 Plan.
In August 2021, the Company hired a new President, who became our CEO in December 2021, and granted an “inducement grant” under Listing Rule 5635(c)(4) of Nasdaq of 55,000 RSUs (designated as “Time-Based Units”) and 55,000 PSUs (designated as “Performance Units”).
2 unchanged sentences
accordingly, these equity awards were not counted against the shares of common stock available for issuance under the 2019 Plan.
−Removed: As of December 31, 2021, 39,440,678 shares of common stock were subject to outstanding awards under our share-based payment award plans and inducement grants (calculated using the base number of PSUs that may vest).
−Removed: If we assume the maximum achievement of performance goals for PSUs, then 42,925,277 shares of common stock will be subject to outstanding awards under our share-based payment award plans and inducement grants.
+Added: As part of the termination agreement with our CEO, 55,000 Performance Units were cancelled and 55,000 RSUs vested in 2022.
+Added: As part of the termination agreements with our Chief Business Officer, 3,900 Performance Units and 11,466 RSUs vested in 2022.
+Added: As of December 31, 2022, 518,074 shares of common stock were subject to outstanding awards under our share-based payment award plans and inducement grants including outstanding PSUs that were vested at 100 % as a result of termination of employees.
The following table summarizes the outstanding awards issued pursuant to our share-based payment award plans and inducement grants as of December 31, 2022 and the remaining shares of common stock available for future issuance (in thousands):
6 unchanged sentences
2021 Inducement Grants
−Removed: The number of PSUs represents the base number of PSUs that may vest.
−Removed: The actual number of PSUs that will vest will be between zero and 11,687,530 depending on the Company’s achievement of certain performance goals.
−Removed: The number of remaining shares of common stock available for future issuance is based on an assumption that the maximu m performance goals for PSUs were achieved, where applicable.
−Removed: As of December 31, 2021, outstanding options have exercise prices ranging from $ 1.07 to $ 2.73 and will expire between January 2022 and June 2030.
−Removed: Unvested RSUs will vest between January 2022 and December 2024.
−Removed: If and when certain performance goals are achieved, then unvested PSUs will vest between June 2022 and March 2024.
−Removed: As of December 31, 2021, outstanding options have exercise prices ranging from $ 2.55 to $ 8.92 and will expire between March 2022 and February 2029.
−Removed: As of December 31, 2021, outstanding options have exercise prices ranging from $ 1.80 to $ 8.92 and will expire between January 2022 and February 2029.
−Removed: As of December 31, 2021, unvested RSUs will vest between August 2022 and October 2024 and unvested PSUs upon achievement of certain performance goals will vest between October 15, 2022 and August 2024.
+Added: The number of PSUs represents the number of PSUs that will vest.
+Added: The number of remaining shares of common stock available for future issuance is based on the number of PSUs that will vest .
+Added: As of December 31, 2022, outstanding options have exercise prices ranging from $ 53.5 to $ 136.5 and will expire on March 30, 2023, due to termination of employees except for awards for one employee and several consultants.
+Added: Unvested RSUs will vest until July 2024.
+Added: The unvested PSUs will vest until April 2025.
+Added: As of December 31, 2022, outstanding options have exercise prices ranging from $ 221.5 to $ 446 and will expire on March 30, 2023, due to termination of employees except for awards for one employee and several consultants.
+Added: As of December 31, 2022, outstanding options have exercise prices ranging from $ 90 to $ 446 and will expire on March 30, 2023 due to termination of employees except for awards for one employee and several consultants.
2021 Exchange of eligible options for RSUs
7 unchanged sentences
Options awards exercisable
−Removed: Balance, January 1, 2019
−Removed: Cancelled/Forfeited
Balance, December 31, 2020
4 unchanged sentences
We used the Black Scholes option pricing model to estimate the fair value of options granted.
+Added: There were no option grants in 2022.
The weighted average fair value of the options granted in 2021 was $ 0.77 per option, and the assumptions used to determine such fair value were as follows:
expected term of 6.9 years, volatility of 67.6 %, dividend yields of 0 % and risk-free interest rates of 1.1 %.
−Removed: The weighted average fair value of the options granted in 2020 was $ 1.58 per option and the assumptions used to determine such fair value were as follows:
−Removed: expected term of 6.0 to 6.8 years , volatility of 63.5 % to 67.9 %, dividend yields of 0 % and risk-free interest rates of 0.3 % to 1.7 %.
−Removed: The weighted average fair value of the options granted in 2019 was $ 3.10 per option and the assumptions used to determine such fair value were as follows:
−Removed: expected term of 5.5 to 6.5 years , volatility of 61.3 % to 64.58 %, dividend yields of 0 % and risk-free interest rates of 1.6 % to 2.5 %.
Restricted stock units
3 unchanged sentences
and not settled
−Removed: Balance, January 1, 2019
Balance, December 31, 2020
17 unchanged sentences
Balance, December 31, 2022
−Removed: The number of PSUs represents the base number of PSUs that may vest.
−Removed: The actual number of PSUs that will vest will be between zero and 11,687,530 depending on the Company’s achievement of certain performance goals.
+Added: The number of PSUs represents the number of PSUs that will vest.
Employee stock purchase plan
2 unchanged sentences
The ESPP permits eligible employees to purchase our common stock at a price per share which is equal to 85 % of the lesser of (i) the fair market value of the shares on the offering date of the offering period or (ii) the fair market value of the shares on the purchase date.
+Added: In 2022, 5,229 shares were sold under the ESPP at the average price of $ 2.6 per share and we received proceeds of approximately $ 14,000 .
In 2021, 6,721 shares were sold under the ESPP at an average sale price of $ 34.5 per share and we received proceeds of $ 0.2 million.
+Added: In the second quarter of 2022, the ESPP Plan was suspended.
Share-based payment compensation cost
−Removed: Share-based payment compensation expense for PSUs is based on our current assessment of the most likely probability of the Company’s achievement of certain performance goals.
−Removed: We recorded share-based payment award compensation costs related to previously issued options, RSU and PSUs, as well as shares of common stock issued under the ESPP totaling $ 18.1 million for 2021, and $ 10.7 million for 2020 and 2019.
−Removed: As of December 31, 2021, we had $ 16.2 million of unrecognized share-based payment award compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under the ESPP, which may be adjusted if certain performance targets are achieved and for future changes in forfeitures and is included as additional paid-in capital in the accompanying consolidated balance sheets.
+Added: Share-based payment compensation expense for PSUs is based on 100 % vesting which was a part of termination of benefits for all employees who were terminated in 2022.
+Added: We recorded share-based payment award compensation costs related to previously issued options, RSU and PSUs, as well as shares of common stock issued under the ESPP totaling $ 11.6 million for 2022 and $ 18.1 million for 2021.
+Added: As of December 31, 2022, we had $ 0.7 million of unrecognized share-based payment award compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under the ESPP, which may be adjusted for future changes in forfeitures and is included as additional paid-in capital in the accompanying consolidated balance sheets.
No tax benefit was realized due to a continued pattern of net losses.
−Removed: The unrecognized compensation cost as of December 31, 2021is expected to be recognized as share-based payment award compensation over a weighted average period of 2.1 years as follows (in thousands):
−Removed: Year ending December 31,
+Added: The unrecognized compensation cost as of December 31, 2022, is expected to be recognized as share-based payment award compensation over a weighted average period of 1.4 years.
Disaggregated revenue
−Removed: The following table provides information about disaggregated revenue by product mix and service (in thousands):
−Removed: Product revenue:
−Removed: Prescription vitamin
−Removed: Product revenue, net
+Added: The following table provides information about disaggregated revenue (in thousands) recognized in continuing operations:
License revenue:
Total revenue, net
−Removed: License agreements with customers
+Added: License agreements
+Added: Mayne license agreement
+Added: Pursuant to a License Agreement, dated December 4, 2022, between the Company and Mayne Pharma (the “Mayne License Agreement”), the Company granted Mayne Pharma, on the Closing Date, (i) an exclusive, sublicensable, perpetual, irrevocable license to research, develop, register, manufacture, have manufactured, market, sell, use, and commercialize the Licensed Products in the United States and its possessions and territories and (ii) an exclusive, sublicensable, perpetual, irrevocable license to manufacture, have manufactured, import and have imported the Licensed Products outside the United States for commercialization in the United States and its possessions and territories.
+Added: Pursuant to the Mayne License Agreement, Mayne Pharma will make one-time, milestone payments to the Company of each of (i) $ 5.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 100.0 million, (ii) $ 10.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 200.0 million and (iii) $ 15.0 million if aggregate net sales of all Products in the United States during a calendar year reach $ 300.0 million.
+Added: Further, Mayne Pharma will pay to the Company royalties on net sales of all Products in the United States at a royalty rate of 8.0 % on the first $ 80 million in annual net sales and 7.5 % on annual net sales above $ 80.0 million, subject to certain adjustments, for a period of 20 years following the Closing Date.
+Added: The royalty rate will decrease to 2.0 % on a Product-by-Product basis upon the earlier to occur of (i) the expiration or revocation of the last patent covering a Product and (ii) a generic version of a Product launching in the United States.
+Added: Mayne Pharma will pay to the Company minimal annual royalties of $ 3.0 million per year for 12 years, adjusted for inflation at an annual rate of 3 %, subject to certain further adjustments, including as described below.
+Added: Upon the expiry of the 20 -year royalty term, the licenses granted to Mayne Pharma under the Mayne License Agreement will become a fully paid-up and royalty free license for the Licensed Products.
+Added: The total consideration from Mayne Pharma to the Company for the purchase of the Transferred Assets and the grant of the licenses under the Mayne Transaction Agreement was (i) a cash payment of $ 140.0 million at closing, (ii) a cash payment of approximately $ 12.1 million at closing for the acquisition of net working capital as determined in accordance with the Transaction Agreement and subject to certain adjustments, (iii) a cash payment of approximately $ 1.0 million at closing for prepaid royalties in connection with the Mayne License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended.
+Added: The proceeds at closing were allocated separately to the sale of ANNOVERA and the license grant related to the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products, as the sale of ANNOVERA was accounted for under ASC 610-20, Gains and Losses from Derecognition of Nonfinancial Assets in arriving at the gain on disposal of approximately $ 62.0 million.
+Added: We also recognized approximately $ 70.0 million in revenue from transaction with Mayne Pharma which represented license to commercialize the Company’s IMVEXXY, BIJUVA, and prescription prenatal vitamin products as well as present value of future minimum royalty payments (as discussed in Note 1).
+Added: On the Closing Date, the Company and Mayne Pharma entered into Amendment No.
+Added: 1 to the Mayne License Agreement (the “Mayne License Agreement Amendment”).
+Added: Pursuant to the Mayne License Agreement Amendment, Mayne Pharma agreed to pay the Company approximately $ 1.0 million in prepaid royalties on the Closing Date.
+Added: The prepaid royalties will reduce the first four quarterly payments that would have otherwise been payable pursuant to the Mayne License Agreement by an amount equal to $ 257,250 per quarterly royalty payment plus interest calculated at 19 % per annum accruing from the Closing Date until the date such quarterly royalty payment is paid to the Company.
+Added: In addition, the parties agreed that Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to the Company by $ 1.5 million in consideration of Mayne Pharma assuming the Company’s obligations under a long-term services agreement, including the Company’s minimum payment obligations thereunder.
Knight license agreement
17 unchanged sentences
Theramex may sublicense its rights to commercialize BIJUVA and IMVEXXY in the Theramex Territory, except for certain specified markets.
−Removed: We may terminate the Theramex License Agreement if Theramex does not submit all regulatory applications, submissions
−Removed: and/or registrations required for regulatory approval to use and commercialize BIJUVA and IMVEXXY within certain specified time periods.
+Added: We may terminate the Theramex License Agreement if Theramex does not submit all regulatory applications, submissions and/or registrations required for regulatory approval to use and commercialize BIJUVA and IMVEXXY within certain specified time periods.
We also may terminate the Theramex License Agreement if Theramex challenges our patents.
Either party may terminate the Theramex License Agreement for any material breach by the other party that is not cured within certain specified time periods or if the other party files for bankruptcy or other related matters.
−Removed: In 2021, we recorded BIJUVA sales of $ 1.4 million made through the Theramex License Agreement.
+Added: In both 2022 and 2021, we recorded BIJUVA sales of $ 1.4 million made through the Theramex License Agreement.
+Added: In addition, in 2021, we received milestone payments comprised of an aggregate of EUR 1.0 million, or $ 1.2 million, in regulatory milestone payments based on regulatory approvals for BIJUVA in certain specified markets.
As of December 31, 2022, no IMVEXXY sales have been made through the either of the licensing agreements.
−Removed: Our loss before income taxes is as follows (in thousands):
+Added: Our income (loss) from continuing operations before income taxes is as follows (in thousands):
United States
−Removed: For 2021, 2020 and 2019, there was no current or deferred provision for income taxes, current or deferred.
+Added: For the year ended December 31, 2022, there was 0 % and 0.5 % provision for income taxes in continuing and discontinued operations, respectively, current or deferred.
+Added: For the year ended December 31, 2021, there was no provision for income taxes in continuing and discontinued operations, current or deferred.
As of December 31, 2022, we had a federal net operating loss (“NOL”) carryforwards of $ 640.0 million, which is available to offset future taxable income.
−Removed: Of the total NOL, $ 338.8 million can be carried forward for 20 years and will begin to expire in 2031 .
+Added: Approximately $ 92.8 million of the federal NOLs can be carried forward for 20 years and will begin to expire in 2031 .
The remaining $ 547.2 million can be carried forward indefinitely.
−Removed: In the event of future income, the NOL deduction arising from NOL generated in taxable years beginning in 2021 will be limited to 80 % of the excess taxable income.
+Added: In the event of future income, the NOL deduction arising from NOLs generated in taxable years beginning in 2021 will be limited to 80 % of the excess taxable income.
+Added: The Company experienced an ownership change pursuant to IRC Sec.
+Added: As a result, our NOLs carryforward as of December 31, 2022 will be limited.
A reconciliation between taxes computed at the federal statutory rate and the consolidated effective tax rate is as follows:
3 unchanged sentences
Excess stock benefits
+Added: Interest expense accretion
Permanent and other differences
−Removed: Provision (benefit) for income taxes
+Added: Provision for income taxes
+Added: Deferred income taxes result from temporary differences between the amount of assets and liabilities recognized for financial reporting and tax purposes.
The components of the net deferred income tax asset as of December 31, 2022 and 2021 are as follows (in thousands):
4 unchanged sentences
Interest expense limitation
+Added: Gain on sale of ANNOVERA
Accrual for sales returns and coupons
2 unchanged sentences
Deferred income tax assets, net
−Removed: We believe that it is more likely than not that we will not generate sufficient future taxable income to realize the tax benefits related to the deferred tax assets on our balance sheet.
−Removed: Accordingly, a valuation allowance has been established against the deferred tax assets as of December 31, 2021 and 2020.
+Added: We believe that it is more likely than not that we will not generate sufficient future taxable income to realize a portion of tax benefits related to the deferred tax assets and as such, a valuation allowance has been established against a portion of the deferred tax assets as of both December 31, 2022 and 2021.
Since our first year of operations in 2011, we generated net operating losses, and our U.S.
1 unchanged sentence
As of December 31, 2022 and 2021, we had no tax positions relating to open tax returns that were considered to be uncertain, and we had no unrecognized tax benefits.
−Removed: Loss per common share
−Removed: The following table sets forth the computation of basic and diluted loss per common share for the periods presented (in thousands, except per share amounts):
−Removed: Weighted average common shares for basic loss per
+Added: Income (loss) per common share
+Added: The following table sets forth the computation of basic and diluted income (loss) per common share for the periods presented (in thousands, except per share amounts):
+Added: Net income (loss) from continuing operations
+Added: Net income (loss) from discontinued operations
+Added: Net income (loss)
+Added: Weighted average common shares for basic income (loss) per
Effect of dilutive securities
−Removed: Weighted average common shares for diluted loss per
−Removed: Loss per common share, basic and diluted
−Removed: Since we reported a net loss for 2021, 2020 and 2019, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities.
−Removed: Therefore, our basic and diluted loss per common share and our basic and diluted weighted average common share are the same for 2021, 2020 and 2019.
+Added: Weighted average common shares for diluted income (loss) per
+Added: Income (loss) per common share, continuing operations
+Added: Income (loss) per common share, discontinued operations
+Added: Since we reported a net loss for 2021, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities.
+Added: Therefore, our basic and diluted loss per common share and our basic and diluted weighted average common share are the same for 2021.
The following table sets forth the outstanding securities as of the periods presented which were not included in the calculation of diluted earnings per common share during 2022 and 2021 (in thousands):
6 unchanged sentences
From July 2015 to December 2021, agreements with Catalent have been reviewed by independent directors of our Company, or a committee consisting of independent directors of our Company.
−Removed: For manufacturing activities, Catalent billed us $ 4.1 million, $ 3.0 million and $ 6.1 million for 2021, 2020 and 2019, respectively.
−Removed: As of December 31, 2021 and 2020, estimated amounts payable to Catalent was $ 0.9 million and $ 0.3 million, respectively.
−Removed: In addition, we have minimum purchase requirements in place with Catalent as disclosed in Note 9, Commitments and contingencies.
+Added: For manufacturing activities, Catalent billed us $ 4.1 million and $ 3.0 million for 2021 and 2020, respectively.
+Added: As of December 31, 2021, estimated amounts payable to Catalent was $ 0.9 million.
+Added: In addition, we have minimum purchase requirements in place with Catalent as disclosed in Note 8, Commitments and contingencies to the financial statements included in this Annual Report.
+Added: The Catalent supply agreements were assigned to Mayne as part of our transaction with Mayne Pharma.
+Added: On August 23, 2022, we appointed Mr.
+Added: Justin Roberts as a director to fill a newly created vacancy on the Board.
+Added: Roberts will serve until the Company’s 2022 Annual Meeting of Stockholders or until his successor is duly elected or appointed or his earlier death or resignation.
+Added: As a director of the Company, Mr.
+Added: Roberts is entitled to receive compensation in the same manner as our other non-employee directors, described in the section entitled “Director Compensation” in our Amendment No.
+Added: 1 to Form 10-K for the fiscal year ended December 31, 2021, filed with the Securities and Exchange Commission on April 29, 2022, but he has elected not to receive any
+Added: compensation for his service as a non-employee director at this time.
+Added: Roberts currently serves as a Partner of the Preferred Stock Investor.
+Added: On July 29, 2022, September 30, 2022 and October 28, 2022, we entered into subscription agreements with Preferred Stock Investor .
+Added: On December 30, 2022, and in accordance with the terms of the Certificate of Designation, the Company redeemed all 29,000 outstanding shares of Series A Preferred Stock at a purchase price of $ 1,333 per share.
+Added: The Company also paid certain affiliates of the Preferred Stock Investor approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously entered into between the Company and Preferred Stock Investor.
+Added: See Note 9 , Mandatory Redeemable Preferred Stock and Stockholders’ Equity ( Deficit ) for additional information.
In April 2020, Karen L.
2 unchanged sentences
From time to time, we have entered into agreements with AIG in the normal course of business.
−Removed: From April 2020 to May 2021, agreements with AIG have been reviewed by independent directors of our Company, or a committee consisting of independent directors of our Company.
+Added: From April 2020 to May 2021, agreements with AIG were reviewed by independent directors of our Company, or a committee consisting of independent directors of our Company.
For various insurance premiums, AIG billed us less than $ 0.1 million and $ 0.2 million for 2021 and 2020, respectively.
−Removed: As of December 31, 2021 and 2020, we have no amounts payable to AIG.
+Added: As of December 31, 2021, we had no amounts payable to AIG.
Business concentrations
−Removed: We sell our products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers.
−Removed: Customers with product revenue equal to or greater than 10 % of our total revenue for the periods indicated were as follows:
−Removed: * Less than 10 % of total product revenue
−Removed: Customers that accounted for 10 % or greater of our accounts receivable as of the periods indicated were as follows:
−Removed: As of December 31,
−Removed: * Balance was less than 10 % of accounts receivable, gross
−Removed: We rely on third parties for the manufacture and supply of our products, as well as third-party logistics providers.
−Removed: In instances where these parties fail to perform their obligations, we may be unable to find alternatives suppliers or satisfactorily deliver our products to our customers on time, if at all.
−Removed: Vendors with product purchases equal to or greater than 10 % of our total purchases for the periods indicated were as follows:
−Removed: * Less than 10 % of total product purchases
−Removed: Vendors that accounted for 10 % or greater of our accounts payable as of the periods indicated were as follows:
−Removed: As of December 31,
−Removed: * Balance was less than 10 % of total accounts payable
−Removed: Summary quarterly information (unaudited)
−Removed: The following table sets forth a summary of the unaudited quarterly results for 2021 and 2020 (in thousands, except per share amounts):
−Removed: September 30,
−Removed: Loss from operations
−Removed: Loss per common share, basic and diluted (1)
−Removed: September 30,
−Removed: Loss from operations
−Removed: Loss per common share, basic and diluted (1)
−Removed: Basic and diluted loss per common share are computed independently for each quarter and the full year based upon respective weighted average shares outstanding.
−Removed: Therefore, the sum of the quarterly basic and diluted earnings per share amounts may not equal the annual basic and diluted earnings per share amounts reported.
−Removed: Included $ 7.3 million in senior executive severances, which included our former EVP of Operations.
−Removed: Included $ 5.1 million in senior executive severances, which included our former CEO.
−Removed: Included (i) $ 2.0 million in license revenue related to the Knight License Agreement, (ii) $ 5.7 million in inventory charge, primarily related to BIJUVA, and (iii) $ 0.6 million in write off of certain costs related to trademarks and patents.
−Removed: Included $ 0.5 million in write off of certain costs related to trademarks and patents.
+Added: TherapeuticsMD was previously a women’s healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause.
+Added: In December 2022, we changed our business to become a pharmaceutical royalty company, currently receiving royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories.
+Added: As part of the transformation that included License Agreement with Mayne Pharma, historical results of commercial operations have been reflected as discontinued operations in the Company’s consolidated financial statements for all periods prior to the Closing Date.
+Added: Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the Company’s consolidated balance sheets.
+Added: Additional disclosures regarding discontinued operations are provided in Note 2.
+Added: In 2022, 98 % of license revenue related to one customer - Mayne Pharma.
+Added: In 2021, 100 % of license revenue related to one customer - Theramex.
+Added: As of December 31, 2022, we had a royalty receivable of $ 1.5 million relating to the short-term portion of receivable from Mayne Pharma and $ 20.3 million relating to long term portion of royalty receivable which includes royalties recognized from the Minimum Annual Royalty (see L.
+Added: Revenue Recognition above).
+Added: As of December 31, 2022, we also recorded $ 1.0 million in prepaid royalties that we received from Mayne Pharma which were recorded in accrued expenses and other current liabilities.
+Added: As of December 31, 2022, three vendors each accounted for more than 10 % of our accounts payable related to continued operations.
+Added: As of December 31, 2021, one vendor accounted for 54.5 % of our accounts payable balance at December 31, 2021 related to continued operations.
Subsequent events
−Removed: vitaCare divestiture
−Removed: On March 6, 2022, we entered into a stock purchase agreement (the “Purchase Agreement”) with GoodRx, Inc.
−Removed: which provides for the sale of all of the issued and outstanding capital stock of vitaCare to GoodRx (the “vitaCare Divestiture”).
−Removed: Under the terms of the Purchase Agreement, upon the closing of the vitaCare divesture (the “Closing”), we will receive a cash payment of $ 150.0 million, subject to adjustment as provided in the Purchase Agreement and customary holdbacks.
−Removed: In addition, we may receive up to an additional of $ 7.0 million in earn-out consideration (the “Earnout”), contingent upon vitaCare’s financial performance through 2023 as determined in accordance with the terms of the Purchase Agreement.
−Removed: The Earnout will be earned in two equal tranches of $ 3.5 million each, based on vitaCare’s revenue for 2022 and 2023.
−Removed: The Purchase Agreement contains customary representations and warranties, covenants and indemnities of the parties thereto.
−Removed: In addition, the Purchase Agreement provides that at the Closing:
−Removed: (i) we will enter into a long-term services agreement with vitaCare to continue utilization of the vitaCare platform with respect to our products;
−Removed: (ii) we and vitaCare will enter into a transition services agreement for us to provide certain transition services to vitaCare for up to 12 months following the Closing;
−Removed: and (iii) certain employees of ours and/or vitaCare will enter into employment agreements with GoodRx.
−Removed: The vitaCare Divestiture is expected to close in the second quarter of 2022, subject to the satisfaction or waiver of certain customary conditions, including the receipt of certain regulatory approvals .
−Removed: Amendment No.
−Removed: 9 to the Financing Agreement
−Removed: In March 2022, we entered into Amendment No.
−Removed: 9 pursuant to which, among other things, (i) the lenders waived various Company breaches of the Financing Agreement, including breaches of the $ 60.0 million minimum cash covenant and the minimum net revenue covenants for the fourth quarter of 2021;
−Removed: (ii) the Company and the lenders agreed to reduced minimum cash covenant and to the removal of the minimum net revenue covenant for the first quarter of 2022;
−Removed: (iii) the lenders waived the existing $ 60.0 million prepayment penalty under the Financing Agreement and the Company agreed to a paid in kind amendment fee of $ 30.0 million, which fee was added to the principal amount of the loans under the Financing Agreement, $ 16.0 million of which fee is waivable in certain conditions;
−Removed: and (iv) the maturity date of the Financing Agreement was am ended to June 1, 2022 .
+Added: On March 28, 2023, we received escrowed funds of $ 11.3 million related to customary holdbacks related to the vitaCare transaction that were recorded as restricted cash in the consolidated balance sheets as of December 31, 2022.
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.