3 unchanged sentences
Condensed Consolidated Balance Sheets
−Removed: (Unaudited – in thousands, except per share data)
−Removed: June 30, 2023
+Added: (in thousands, except share data)
+Added: September 30, 2023
December 31, 2022
Current assets:
+Added: Cash and cash equivalents
Restricted cash
19 unchanged sentences
Common stock, par value $ 0.001 ;
−Removed: 12,000 shares authorized, 10,575
−Removed: and 9,498 issued and
−Removed: outstanding as of June 30, 2023 and December 31, 2022, respectively
+Added: 32,000 and 12,000 shares authorized, 10,575 and 9,498 shares
+Added: issued and outstanding as of September 30, 2023 and December 31, 2022, respectively
Additional paid-in
5 unchanged sentences
and Subsidiaries
−Removed: Condensed Consolidated Statements of Operations
+Added: Condensed Consolidated Statements of Comprehensive Income
(Unaudited - in thousands, except per share data)
−Removed: Three Months Ended
−Removed: Six Months Ended
−Removed: Revenue, net:
−Removed: License and service
−Removed: Total revenue, net
+Added: Three Months Ended September 30,
+Added: Nine Months Ended September 30,
+Added: License and service revenue
Cost of revenue
+Added: Gross profit (loss)
Operating expenses:
17 unchanged sentences
Net income (loss)
−Removed: Other comprehensive incom e
+Added: Other comprehensive income
Comprehensive income (loss):
5 unchanged sentences
Balance, January 1, 2023
−Removed: Shares issued for vested restricted stock units and warrants
+Added: Shares issued for vested restricted stock units
Share-based compensation
Balance, March 31, 2023
−Removed: Shares issued for vested restricted stock units and warrants
+Added: Shares issued for vested restricted stock units
Shares issued for sale of common stock related to private placement sale
1 unchanged sentence
Balance, June 30, 2023
+Added: Share-based compensation
+Added: Balance, September 30, 2023
Balance, January 1, 2022
7 unchanged sentences
Balance, June 30, 2022
+Added: Sale of common stock, net of costs
+Added: Shares issued for vested restricted stock units
+Added: Share-based compensation
+Added: Balance, September 30, 2022
The accompanying notes are an integral part of these condensed consolidated financial statements.
3 unchanged sentences
(Unaudited - in thousands)
−Removed: Six Months Ended June 30,
+Added: Nine Months Ended September 30,
Cash flows from operating activities:
2 unchanged sentences
Net loss from continuing operations
−Removed: Adjustments to reconcile net loss to net cash used in continuing operating activities:
+Added: Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
5 unchanged sentences
Accrued expenses and other current liabilities
+Added: Lease liabilities
Other non-current
7 unchanged sentences
Proceeds from sale of common stock, net of costs
+Added: Proceeds from exercise of options and warrants
Repayments of debt
−Removed: Net cash (used in) provided by continuing financing activities
+Added: Payment of debt financing fees
+Added: Net cash provided by (used in) continuing financing activities
Discontinued operations:
4 unchanged sentences
Net decrease in cash
−Removed: Cash and restricted cash – continuing operations, beginning of period
−Removed: Cash and restricted cash – discontinued operations, beginning of period
+Added: Cash, cash equivalents and restricted cash - continuing operations, beginning of period
+Added: Cash, cash equivalents and restricted cash - discontinued operations, beginning of period
Total cash and restricted cash, end of period
2 unchanged sentences
Supplemental disclosure of noncash financing activities:
−Removed: Paid in kind (“PIK”) debt financing fees with corresponding increase in debt
+Added: Paid in kind (“PIK”) interest with corresponding increase in debt
+Added: PIK debt financing fees with corresponding increase in debt
+Added: Issue of warrants to lenders related to debt financing fees
The accompanying notes are an integral part of these condensed consolidated financial statements.
14 unchanged sentences
Report may appear without the ®
−Removed: symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks.
+Added: , TM or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks.
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.
1 unchanged sentence
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.
−Removed: On December 30, 2022 (the “Closing Date”), we 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, in which we and our subsidiaries (i) granted Mayne Pharma an exclusive license to commercialize our IMVEXXY, BIJUVA and prescription prenatal vitamin products sold under the BocaGreenMD ®
−Removed: and vitaMedMD ®
−Removed: brands (collectively, the “Licensed Products”) in the United States and its possessions and territories, (ii) assigned to Mayne Pharma our exclusive license to commercialize ANNOVERA ®
+Added: On December 30, 2022 (the “Closing Date”), we 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, in which we and our subsidiaries (i) granted Mayne Pharma an exclusive license to commercialize our 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 our 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.
15 unchanged sentences
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 thousand 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 us.
−Removed: In addition, the parties agreed that Mayne Pharma will reduce one quarterly royalty payment (other than the first quarterly royalty payment) otherwise payable to TherapeuticsMD by $ 1.5 million in consideration of Mayne Pharma assuming our obligations under a long-term services agreement (see the section entitled “vitaCare divestiture” below for a discussion of the long-term services agreement), including our minimum payment obligations thereunder.
+Added: We and Mayne Pharma settled the $ 1.5 million of consideration due to Mayne for the assumed obligations under a long-term services agreement (see the section entitled “vitaCare divestiture” below for a discussion of the long-term services agreement), including our minimum payment obligations thereunder.
+Added: As the parties agreed, during the second quarter of 2023, Mayne Pharma held back our royalty payment and we funded an additional
+Added: $ 0.9 million in August 2023 to settle the original
+Added: $ 1.5 million payable
As part of the transformation that included the Mayne License Agreement, historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in our condensed consolidated financial statements.
4 unchanged sentences
(“Knight”) pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel.
−Removed: In June 2019, we entered into an exclusive license and supply agreement (the “Theramex License Agreement”) with Theramex HQ UK Limited (“Theramex”) to commercialize IMVEXXY and BIJUVA outside of the U.S., excluding Canada and Israel.
+Added: In September 2019, we entered into an exclusive license and supply agreement (the “Theramex License Agreement”) with Theramex HQ UK Limited (“Theramex”) to commercialize IMVEXXY and BIJUVA outside of the U.S., excluding Canada and Israel.
In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries.
2 unchanged sentences
Severance obligations for all employees other than executive officers were paid in full in January 2023 and severance obligations for terminated executive officers are paid in accordance with their employment agreements and separation agreements as previously disclosed.
−Removed: As of December 31, 2022 and June 30, 2023, we employed one full-time employee primarily engaged in an executive position.
−Removed: We have also entered into consulting agreements with certain former members of our management team, including our Principal Financial Officer, 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: As of December 31, 2022 and September 30, 2023, we employed one full-time employee primarily engaged in an executive position.
+Added: We have engaged external consultants 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: On August 15, 2023, we entered into a master services agreement with JZ Advisory Group, pursuant to which Joseph Ziegler would serve as our Principal Financial Officer.
+Added: On August 17, 2023 Michael C.
+Added: Donegan notified us of his decision to resign from the positions of Principal Financial and Accounting Officer of our Company effective as of August 17, 2023.
+Added: Ziegler succeeded Mr.
+Added: Donegan as Principal Financial and Accounting Officer as of the date of Mr.
+Added: Donegan’s resignation.
vitaCare Divestiture
3 unchanged sentences
Included in the net proceeds amount was $ 11.3 million of customary holdbacks as provided in the stock purchase agreement (the “Purchase Agreement”) which we received in 2023.
−Removed: Additionally, the vitaCare Divestiture provides that we may receive up to an additional $ 7.0 million in earn-out
−Removed: consideration, contingent upon vitaCare’s financial performance through 2023 as determined in accordance with the terms of the Purchase Agreement, however we do not believe this earnout will be realized.
+Added: Additionally, the Purchase Agreement provides that we may receive up to an additional
+Added: $ 7.0 million in earn-out
+Added: consideration, contingent upon vitaCare’s financial performance through 2023 as determined in accordance with the terms of the Purchase Agreement;
+Added: however, we do not believe this earnout will be realized.
We will record the contingent consideration at the settlement amount if and when the consideration is realized or realizable.
1 unchanged sentence
The commitments under a long-term services agreement related to vitaCare were transferred to Mayne Pharma as part of the Mayne Transaction.
−Removed: 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.
−Removed: The divestiture of vitaCare was determined to be a component of discontinued operations in December 2022, when we changed our business by becoming a royalty company and as a result vitaCare activities were reclassified to discontinued operations for the six months ended June 30, 2023 and 2022.
+Added: In addition, under the Mayne License Agreement Amendment, we owed Mayne Pharma
+Added: $ 1.5 million payable from one royalty payment.
+Added: During the second quarter of 2023, Mayne Pharma held back our royalty payment and we funded an additional $ 0.9 million in August 2023 to settle the original $ 1.5 million payable.
+Added: The divestiture of vitaCare was determined to be a component of discontinued operations in December 2022, when we changed our business by becoming a royalty company and as a result vitaCare activities were reclassified to discontinued operations for the nine months ended September 30, 2023 and 2022.
With multiple variant strains of the SARS-Cov-2
20 unchanged sentences
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: On May 1, 2023, we entered into a Subscription Agreement (the “Subscription Agreement”) with Rubric Capital Management LP (“Rubric”), pursuant to which we agreed to sell to Rubric, or one or more of its affiliates, up to an aggregate of 5,000,000 shares of our common stock, par value $ 0.001 per share (our “Common Stock”), from time to time during the term of the Subscription Agreement in separate draw-downs at the election of the Company.
−Removed: On June 29, 2023, the Company issued and sold 312,525 shares of Common Stock at a price per share equal to $ 3.6797 pursuant to the Subscription Agreement.
−Removed: The Company received gross proceeds of $ 1.15 million from the draw down, before expenses.
+Added: On May 1, 2023, we entered into a Subscription Agreement (the “Subscription Agreement”) with Rubric Capital Management LP (“Rubric”), pursuant to which we agreed to sell to Rubric, or one or more of its affiliates, up to an aggregate of 5,000,000 shares of our common stock, par value $ 0.001 per share (our “Common Stock”), from time to time during the term of the Subscription Agreement in separate draw-downs at our election.
+Added: On June 29, 2023, we issued and sold 312,525 shares of Common Stock at a price per share equal to $ 3.6797 pursuant to the Subscription Agreement.
+Added: We received gross proceeds of $ 1.15 million from the draw down, before expenses.
The Common Stock issued pursuant to the Subscription Agreement was sold and issued without registration under the Securities Act of 1933, as amended (the “Securities Act”), in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act as transactions not involving a public offering and Rule 5-06
of Regulation D promulgated under the Securities Act as sales to accredited investors, and in reliance on similar exemptions under applicable state laws.
−Removed: 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 is greater than estimated, if we are unsuccessful with future financings or if the continued impact of the COVID-19
+Added: If Mayne Pharma’s sales of IMVEXXY, BIJUVA, or ANNOVERA grow more slowly than expected or decline, if the net working capital settlement with Mayne Pharma under the Transaction Agreement is greater than our current estimates, if we are unsuccessful with future financings or if the continued impact of the COVID-19
pandemic on us or the third-parties we or our licensees rely on or the supply chains related to the third-party contract manufacturers are worse than we anticipate, our existing cash reserves may be insufficient to satisfy our liquidity requirements.
8 unchanged sentences
(the “2022 10-K
−Removed: As part of the transformation as a result of the Mayne Tran sa
−Removed: ction, historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in the condensed consolidated financial statements.
+Added: As part of the transformation as a result of the Mayne Transaction, historical results of commercial operations for all periods prior to the Closing Date have been reflected as discontinued operations in the condensed consolidated financial statements.
Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in the condensed consolidated balance sheet.
2 unchanged sentences
Therefore, the results and trends in these interim financial statements may not be representative of those for the full year.
−Removed: In our opinion, all adjustments necessary for a fair statement of the financial statements, which are of a normal and recurring nature, have been made for the interim periods reported.
+Added: In our opinion, all adjustments necessary for a fair
+Added: of the financial statements, which are of a normal and recurring nature, have been made for the interim periods reported.
The information included in this 10-Q
−Removed: Report should be read in conjunction with the condensed consolidated financial statements and accompanying notes included in our 2022 10-K
+Added: Report should be read in conjunction with the consolidated financial statements and accompanying notes included in our 2022 10-K
Certain amounts in the consolidated financial statements and accompanying notes may not add due to rounding, and all percentages have been calculated using unrounded amounts.
+Added: Certain prior period amounts have been reclassified to conform to current-period presentation.
New accounting standards
Adoption of new accounting standards
−Removed: New accounting standards or “ASUs” were assessed and determined to be either not applicable or did not have a material impact on our condensed consolidated financial statements or processes.
+Added: New accounting standards or “ ASU
+Added: s” were assessed and determined to be either not applicable or did not have a material impact on our condensed consolidated financial statements or processes.
Common stock reverse stock split
10 unchanged sentences
Increase of authorized shares
−Removed: On June 26, 2023, at our combined 2022 and 2023 Annual Meeting, our stockholders approved an amendment to o
−Removed: Amended and Restated Articles of Incorporation to increase the number of authorized shares of Common Stock from 12 million shares to 32 million shares.
+Added: On June 26, 2023, at our combined 2022 and 2023 Annual Meeting, our stockholders approved an amendment to our Amended and Restated Articles of Incorporation to increase the number of authorized shares of Common Stock from 12 million shares to 32 million shares.
Estimates and assumptions
−Removed: The preparation of our condensed consolidated financial statements in conformity to U.S.
−Removed: GAAP requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period.
+Added: The preparation of our condensed consolidated financial statements in conformity with U.S.
+Added: GAAP requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods.
We evaluate our estimates and assumptions based on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
6 unchanged sentences
This plan represented a strategic shift having a major effect on our operations and financial results.
−Removed: Upon our conversion from a commercial pharmaceutical company to a licensing only company with the consummation of the Mayne Transaction, we classified all direct revenues, costs and expenses related to commercial operations, within income (loss) from discontinued operations, net of tax, in the condensed consolidated statements of operations for all periods presented.
−Removed: no t allocated
−Removed: any amounts for shared general and administrative operating support expense to discontinued operations.
−Removed: As required by the terms of the Financing Agreement, proceeds from the Mayne Transaction and the VitaCare Divestiture 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
−Removed: disclosed below).
−Removed: , the related assets and liabilities have been reported as assets and liabilities of discontinued operations in our condensed consolidated balance sheets as of June 30, 3023 and December 31, 2022.
+Added: Upon our conversion from a commercial pharmaceutical company to a licensing only company with the consummation of the Mayne Transaction, we classified all direct revenues, costs and expenses related to commercial operations, within income (loss) from discontinued operations, net of tax, in the condensed consolidated statements of comprehensive income for all periods
+Added: We have no t allocated any amounts for shared general and administrative operating support expense to discontinued operations.
+Added: As required by the terms of the Financing Agreement, proceeds from the Mayne Transaction and the VitaCare Divestiture 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 our condensed consolidated balance sheets as of September 30, 2023 and December 31, 2022.
The total consideration from Mayne Pharma consisted of (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 Mayne License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended.
3 unchanged sentences
We believe that our estimate of net working capital is reasonable and intend to resolve this matter through the process outlined in the Transaction Agreement.
−Removed: Given the nature of the estimates involved, the outcome of this matter is uncertain at this point.
−Removed: As a result, we cannot reasonably estimate a range of loss, and accordingly, continue to contemplate any additional liability associated with Mayne Pharma’s calculation.
+Added: During the three months ended September 30, 2023, we revised certain estimates pertaining to contracts we were a party to when we were an operating company.
+Added: These included an incremental accrual of approximately
+Added: $ 2 million for net working capital adjustments related to the Transaction Agreement .
The following table presents results of discontinued operations (in thousands):
−Removed: Three months ended June, 30
−Removed: Six Months Ended June 30,
+Added: Three months ended September 30,
+Added: Nine Months Ended September 30,
Product revenue, net
4 unchanged sentences
Research and development
−Removed: Depreciation & a
+Added: Depreciation & amortization
Total operating expenses
−Removed: Operating profit (loss) from discontinued operations
+Added: Operating loss from discontinued operations
Other income (expense), net
1 unchanged sentence
Net income (loss) from discontinued operations
−Removed: The following table presents the carrying amounts of the classes of assets and liabilities of discontinued operations as of June 30, 2023 and December 31, 2022 (in thousands):
−Removed: June 30, 2023
+Added: The following table presents the carrying amounts of the classes of assets and liabilities of discontinued operations as of September 30, 2023 and December 31, 2022 (in thousands):
+Added: September 30, 2023
December 31, 2022
4 unchanged sentences
Prepaid and other current assets
−Removed: Our prepaid and other current assets consisted of the following as of June 30, 2023 and December 31, 2022 (in thousands):
−Removed: June 30, 2023
+Added: Our prepaid and other current assets consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands):
+Added: September 30, 2023
December 31, 2022
+Added: Rent receivable
Capitalized legal
Prepaid and other current assets
−Removed: Our fixed assets, net consisted of the following as of June 30, 2023 and December 31, 2022 (in thousands):
−Removed: June 30, 2023
+Added: Our fixed assets, net consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands):
+Added: September 30, 2023
December 31, 2022
5 unchanged sentences
Fixed assets, net
−Removed: We recorded, in continuing operations, depreciation expense of $ 0.0 million and $ 0.2 million for the three months ended June 30, 2023 and 2022, respectively, and depreciation expense of $ 0.0 million and $ 0.3 million for the six months ended June 30, 2023 and 2022, respectively.
+Added: We recorded, in continuing operations, depreciation expense of $ 0.0 million and $ 0.2 million for the three months ended September 30, 2023 and 2022, respectively, and depreciation expense of $ 0.0 million and $ 0.4 million for the nine months ended September 30
+Added: , 2023 and 2022, respectively.
Licensed rights and other intangible assets
−Removed: The following provides information about our license rights and other intangible assets, net as of June 30, 2023 and December 31, 2022 (in thousands):
−Removed: June 30, 2023
+Added: The following provides information about our license rights and other intangible assets, net as of September 30, 2023 and December 31, 2022 (in thousands):
+Added: September 30, 2023
December 31, 2022
−Removed: Gross Carrying
Intangible assets subject to amortization:
5 unchanged sentences
License rights and other intangible assets, net
−Removed: We recorded, in continuing operations, amortization expense related to patents of $ 0.1 million and $ 0.1 million for the three months ended June 30, 2023 and 2022 respectively, and amortization expense related to patents of $ 0.1 million and $ 0.3 million for the six months ended June 30, 2023 and 2022 respectively.
+Added: We recorded, in continuing operations, amortization expense related to patents of $ 0.1 million and $ 0.1 million for the three months ended September 30, 2023 and 2022 ,
+Added: respectively, and amortization expense related to patents of $ 0.2 million and $ 0.4 million for the nine months ended September 30, 2023 and 2022 ,
+Added: respectively.
Our intangible assets subject to amortization are expected to be amortized as follows (in thousands):
2 unchanged sentences
Other accrued expenses and other current liabilities consisted of the following (in thousands):
−Removed: June 30, 2023
+Added: September 30, 2023
December 31, 2022
9 unchanged sentences
Mayne Pharma Agreement
−Removed: Mayne Pharma paid us approximately $ 12.1 million at closing on December 30, 2022, for the acquisition of net working capital, as determined in accordance with the Transaction Agreement, and such payment
−Removed: is subject to certain adjustments for a period of up to two years following the Closing Date.
+Added: Mayne Pharma paid us approximately $ 12.1 million at closing on December 30, 2022, for the acquisition of net working capital, as determined in accordance with the Transaction Agreement, and such payment is subject to certain adjustments for a period of up to two years following the Closing Date.
+Added: During the three months ended September 30, 2023, we revised certain estimates;
+Added: including an incremental accrual of approximately
+Added: million for net working capital adjustments related to the Transaction Agreement .
Pursuant to the Mayne License Agreement Amendment, Mayne Pharma also paid us approximately $ 1.0 million in prepaid royalties on the Closing Date.
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 us.
−Removed: In addition, 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 a long-term services agreement, including our minimum payment obligations thereunder.
−Removed: We recognized
−Removed: $ 0.4 million and $ 0.9 million in royalty revenues
−Removed: from Mayne Pharma during the three and six months ended June 30, 2023, respectively.
+Added: Additionally, we owed Mayne Pharma
+Added: $ 1.5 million payable from one royalty payment.
+Added: During the second quarter of 2023, Mayne Pharma held back our royalty payment and we funded an additional
+Added: million in August 2023 to settle the original
+Added: $ 1.5 million payable.
+Added: We recognized $( 0.1 ) million and $ 0.8 million in royalty revenues from Mayne Pharma during the three and nine months ended September 30, 2023, respectively.
Population Council License Agreement
12 unchanged sentences
We are seeking, among other relief, an order that the effective date of any FDA approval of Teva’s ANDA would be a date no earlier than the expiration of the IMVEXXY Patents and equitable relief enjoining Teva from infringing the IMVEXXY Patents.
−Removed: Teva has filed its answer and counterclaim to the complaint, alleging that the IMVEXXY Patents are invalid and not infringed.
+Added: Teva has filed its answer and counterclaim to the complaint, alleging that the IMVEXXY Patents are invalid and not
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 order following the parties’ agreement to a consent motion to redact
−Removed: information Teva contended was confidential.
+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.
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.
−Removed: We have incurred and recorded legal costs amounting to $ 2.3 million in prepaid expenses and other current assets as of June 30, 2023, for the IMVEXXY Paragraph IV legal proceeding since we believe that we will successfully prevail in this legal proceeding.
+Added: We have incurred and recorded legal costs amounting to $ 2.3 million in prepaid expenses and other current assets as of September 30, 2023, for the IMVEXXY Paragraph IV legal proceeding since we believe that we will successfully prevail in this legal proceeding.
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 condensed consolidated balance sheets, and such costs will be amortized over the remaining useful life of the patents.
1 unchanged sentence
Beginning on December 30, 2022 and per the Mayne License Agreement, Mayne Pharma is responsible for all enforcement of our patents, including the litigation discussed above with respect to Teva.
+Added: In September 2023, one of our former contractors retained to market Annovera under Title X, filed a lawsuit that accused us of breach of contract.
+Added: We answered their complaint and filed breach of contract counterclaims.
From time to time, we are involved in other litigations and proceedings in the ordinary course of business.
1 unchanged sentence
sheet arrangements
−Removed: As of June 30, 2023 and December 31, 2022 we had no off-balance
−Removed: sheet arrangements that have had or are reasonably likely to have current or future effects on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors.
+Added: As of September 30, 2023 and December 31, 2022 we had no off-balance
+Added: sheet arrangements that have had or are reasonably likely to have current or future effects on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that we consider material.
Employment agreements
2 unchanged sentences
Severance obligations for all employees other than executive officers were paid in full in the first quarter of 2023.
−Removed: As of June 30, 2023, we employ one full-time employee primarily engaged in an executive position.
−Removed: 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: As of September 30, 2023, we employ one full-time employee primarily engaged in an executive position.
+Added: We have engaged external consultants 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.
The separation of our former Interim Co-Chief
Executive Officers, former Interim Chief Financial Officer and other executives from TherapeuticsMD was each a termination without “Good Cause,” as defined in their respective employment agreements.
−Removed: In the aggregate, as of June 30, 2023, we have accrued severance liabilities for executive termination obligations of $ 2.4 million.
+Added: In the aggregate, as of September 30, 2023, we have accrued severance liabilities for executive termination obligations of $ 1.6 million.
Stockholders’ equity (deficit)
−Removed: As of June 30, 2023, the following table summarizes the status of our outstanding and exercisable warrants and related transactions since December 31, 2022 (in thousands, except weighted average exercise price and weighted average remaining contractual life data):
+Added: As of September 30, 2023, the following table summarizes the status of our outstanding and exercisable warrants and related transactions since December 31, 2022 (in thousands, except weighted average exercise price and weighted average remaining contractual life data):
Warrants Outstanding and exercisable
6 unchanged sentences
As of January 1, 2022
−Removed: As of June 30, 2023
+Added: As of September 30, 2023
Share-based compensation payment plans
−Removed: As of June 30, 2023, 269,207 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: As of June 30, 2023,
−Removed: 321,717 shares of common stock were available for future grants of share-based payment awards under the TherapeuticsMD, Inc.
+Added: As of September 30, 2023, 382,207 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).
+Added: As of September 30, 2023, 392,504 shares of common stock were available for future grants of share-based payment awards under the TherapeuticsMD, Inc.
2019 Stock Incentive Plan.
2 unchanged sentences
Cancelled/Forfeited
−Removed: As of June 30, 2023
+Added: As of September 30, 2023
The following table summarizes the status of our RSUs and related transactions (each adjusted to account for the Reverse Stock Split) since December 31, 2022 (in thousands, except weighed average grant date fair value):
RSUs awards outstanding
−Removed: RSUs awards vested and not
As of January 1, 2023
−Removed: Vested and settled
Cancelled/Forfeited
−Removed: As of June 30, 2023
+Added: Unvested as of September 30, 2023
The following table summarizes the status of our PSUs and related transactions for each for the following years (each adjusted to account for the Reverse Stock Split) since December 31, 2022 (in thousands, except weighed average grant date fair value):
−Removed: Vested and not settled
−Removed: As of January 1, 2023
−Removed: Vested and settled
+Added: Unvested as of January 1, 2023
Cancelled/Forfeited
−Removed: As of June 30, 2023
−Removed: The number of PSUs represents the base number of PSUs that may
+Added: Unvested, as of September 30, 2023
+Added: The number of PSUs represents the base number of PSUs that may vest.
Share-based payment compensation cost
−Removed: Share-based payment compensation expense for PSUs is based on 100 % vesting which was a part of the
−Removed: termination benefits for all employees who were terminated in 2022.
−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 our ESPP totaling $ 0.4 million and $ 2.2 million for the three months ended June 30, 2023 and 2022 respectively, and $ 0.9 million and $ 4.3 million for the six months ended June 30, 2023 and 2022 respectively.
−Removed: As of June 30, 2023, we had $ 0.5 million of unrecognized share-based payment award compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under our ESPP, which may be adjusted for future changes in forfeitures and is included as additional paid-in
+Added: Share-based payment compensation expense for PSUs is based on 100 % vesting which was a part of the termination 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 our employee stock purchase plan (“ESPP”)
+Added: totaling $ 0.2 million and $ 4.3 million for the three months ended September 30, 2023 and 2022 ,
+Added: respectively, and $ 1.2 million and $ 8.5 million for the nine months ended September 30, 2023 and 2022 ,
+Added: respectively.
+Added: As of September 30, 2023, we had $ 0.4 million of unrecognized share-based payment award compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under our ESPP, which may be adjusted for future changes in forfeitures and is included as additional paid-in
capital in the accompanying condensed consolidated balance sheets.
No tax benefit was realized due to a continued pattern of net losses.
−Removed: The unrecognized compensation cost as of June 30, 2023 of $ 0.5 million is expected to be recognized as share-based payment award compensation over a weighted average period of 0.6 years.
+Added: The unrecognized compensation cost as of September 30, 2023 of $ 0.4 million is expected to be recognized as share-based payment award compensation over a weighted average period of 0.6 years.
Pursuant to 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.
8 unchanged sentences
and royalty free license for the Licensed Products.
−Removed: We do not expect to pay any significant federal or state income taxes as a result of (i) the losses recorded during the six months ended June 30, 2023 and 2022, (ii) additional losses expected for the remainder of 2023 or losses recorded in 2022, or (iii) net operating losses carry forwards from prior years.
−Removed: We recorded a full valuation allowance of the net operating losses for the six months ended June 30, 2023 and 2022.
−Removed: Accordingly, there were no provisions for income taxes for the six months ended June 30, 2023 and 2022.
−Removed: Additionally, as of June 30, 2023 and December 31, 2022, we maintain a full valuation allowance for all deferred tax assets.
−Removed: Loss per common share
+Added: We reported revenue of ($ 0.1 ) million in the third quarter of 2023 due to changes in estimates of revenue amounting to ($ 0.3 ) million subject to royalty due to TXMD by Mayne.
+Added: Additionally, a portion of this adjustment is due to reallocations of revenue to other income (expense).
+Added: On a quarterly basis, we reallocate royalty revenue proportionately between operating revenue for the amounts related to our licensed intellectual property and other income for royalties related to intellectual property we sold.
+Added: We do not expect to pay any significant federal or state income taxes as a result of (i) the losses recorded during the nine months ended September 30, 2023 and 2022, (ii) additional losses expected for the remainder of 2023 or losses recorded in 2022, or (iii) net operating losses carry forwards from prior years.
+Added: We recorded a full valuation allowance of the net operating losses for the nine months ended September 30, 2023 and 2022.
+Added: Accordingly, there were no provisions for income taxes for the nine months ended September 30, 2023 and 2022.
+Added: Additionally, as of September 30, 2023 and December 31, 2022, we maintain a full valuation allowance for all deferred tax assets.
+Added: Income (Loss) per common share
The following table sets forth the computation of basic and diluted (loss) per common share (each adjusted to account for the Reverse Stock Split) for the periods presented (in thousands, except per share amounts):
−Removed: Three Months Ended
−Removed: Six Months Ended
+Added: Three Months Ended September 30,
+Added: Nine Months Ended September 30,
Net income (loss) from continuing operations
Net income (loss) from discontinued operations
+Added: Net income (loss)
Weighted average common shares for basic loss per common share
3 unchanged sentences
Income (loss) per common share, discontinued operations
−Removed: Since we reported a net loss from continuing operations for the six months ended June 30, 2023 and 2022, 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 shares are the same for the six months ended June 30, 2023 and 2022.
−Removed: 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 the respective six months ended June 30, 2023 and 2022 (in thousands):
−Removed: Six Months Ended June 30,
+Added: Since we reported a net loss from continuing operations for the nine months ended September 30, 2023 and 2022, 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 shares are the same for the nine months ended September 30, 2023 and 2022.
+Added: 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 the respective nine months ended September 30, 2023 and 2022 (in thousands):
+Added: September 30, 2023
Stock options
14 unchanged sentences
also paid certain affiliates of Rubric approximately $ 3.0 million as a make-whole payment pursuant to the subscription agreements previously entered into between us and Rubric.
−Removed: On June 29, 2023, the Company issued and sold 312,525 shares of Common Stock to Rubric at a price per share equal to $ 3.6797 pursuant to the Subscription Agreement and received gross proceeds of $ 1.15 million, before expenses.
+Added: On June 29, 2023, we issued and sold 312,525 shares of Common Stock to Rubric at a price per share equal to $ 3.6797 pursuant to the Subscription Agreement and received gross proceeds of $ 1.15 million, before expenses.
Business concentrations
4 unchanged sentences
Additional disclosures regarding discontinued operations are provided in Note 2.
−Removed: For the three and six months ended June 30, 2023, 100 % of license revenue related to Mayne Pharma and Theramex.
−Removed: As of June 30, 2023, we had a royalty receivable of $ 0.8 million relating to the short-term portion of receivable from Mayne Pharma and Theramex and $ 19.8
−Removed: million relating to the long-term portion of royalty receivable which includes royalties recognized from the minimum annual royalty that Mayne Pharma is obligated to pay to us under the Mayne License Agreement.
+Added: For the three and nine months ended September 30, 2023, 100 % of license revenue related to Mayne Pharma and Theramex.
+Added: As of September 30, 2023, we had a royalty receivable of $ 2.7 million relating to the short-term portion of receivable from Mayne Pharma and Theramex and $ 19.1 million relating to the long-term portion of royalty receivable which includes royalties recognized from the minimum annual royalty that Mayne Pharma is obligated to pay to us under the Mayne License Agreement.
+Added: Subsequent events
+Added: On November 10, 2023, we delivered a drawdown notice (the “Notice”) to Rubric under the terms of the Subscription Agreement.
+Added: Pursuant to the Notice, we agreed to sell 877,192 shares of Common Stock to Rubric at a price per share of $ 2.28 , for total gross proceeds of approximately $ 2.0 million.
+Added: The settlement of the transaction is expected to occur on the third trading day following the delivery of the Notice in accordance with the terms of the Subscription Agreement.
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.