Item 1. Financial Statements
Item 1. Financial statements
TherapeuticsMD, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(Unaudited – in thousands, except per share data)
March 31, 2023
December 31, 2022
Assets:
Current assets:
Cash
$
17,248
$
38,067
Restricted cash
—
11,250
Royalty receivable,
current portion
2,041
—
Prepaid and other current assets
5,446
6,034
Total current assets
24,735
55,351
Fixed assets, net
58
78
License rights and other intangible assets, net
6,877
6,943
Right of use assets
7,406
7,580
Royalty receivable, long term
20,272
20,253
Other non-current
assets
253
253
Total assets
$
59,601
$
90,458
Liabilities and stockholders’ equity:
Current liabilities:
Accounts payable
$
2,326
$
2,162
Accrued expenses and other current liabilities
14,360
18,846
Current liabilities of discontinued operations
2,650
25,831
Total current liabilities
19,336
46,839
Operating lease liabilities
7,135
7,369
Other non-current
liabilities
1,106
1,107
Total liabilities
27,577
55,315
Commitments and contingencies (Note 9)
Stockholders’ equity:
Preferred stock, par value $ 0.001 ; 10,000 shares authorized, no ne issued
—
—
Common stock, par value $ 0.001 ; 12,000 shares authorized, 9,548 and
9,498 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively
10
9
Additional paid-in
capital
974,980
974,497
Accumulated deficit
( 942,966
)
( 939,363
)
Total stockholders’ equity
32,024
35,143
Total liabilities and stockholders’ equity
$
59,601
$
90,458
The accompanying notes are an integral part of these condensed consolidated financial statements.
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TherapeuticsMD, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited – in thousands, except per share data)
Three Months Ended March 31,
2023
2022
Revenue, net:
License and service
$
416
$
695
Total revenue, net
416
695
Cost of revenue
—
695
Gross profit
416
—
Operating expenses:
Selling, general and administrative
3,056
17,546
Depreciation & amortization
27
329
Total operating expenses
3,083
17,875
Income (loss) from operations
( 2,667
)
( 17,875
)
Other (expense) income:
Interest expense and other financing costs
( 50
)
—
Miscellaneous income
407
—
Total other income, net
357
—
Income (loss) from continuing operations before income taxes
( 2,310
)
( 17,875
)
Income (loss) from discontinued operations, net of income taxes
( 1,293
)
( 31,146
)
Net income (loss)
$
( 3,603
)
$
( 49,021
)
Income (loss) per common share, basic and diluted:
Continuing operations
( 0.24
)
( 2.08
)
Discontinued operations, net
( 0.13
)
( 3.62
)
Net income (loss) per common share, basic and diluted
$
( 0.37
)
$
( 5.70
)
Weighted average common shares, basic
9,754
8,614
Weighted average common shares, diluted
9,754
8,614
Net income (loss)
$
( 3,603
)
$
( 49,021
)
Other comprehensive income
—
—
Comprehensive income (loss):
$
( 3,603
)
$
( 49,021
)
The accompanying notes are an integral part of these condensed consolidated financial statements.
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TherapeuticsMD, Inc. and Subsidiaries
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
(Unaudited – in thousands)
Common Stock
Additional
Paid in
Capital
Accumulated
Deficit
Total
Shares
Amount
Balance, January 1, 2023
9,498
$
9
$
974,497
$
( 939,363
)
$
35,143
Shares issued for vested stock compensation and warrants
455
1
—
—
1
Share-based compensation
—
—
483
—
483
Net loss
—
—
—
( 3,603
)
( 3,603
)
Balance, March 31, 2023
9,953
$
10
$
974,980
$
( 942,966
)
$
32,024
Balance, January 1, 2022
8,598
$
9
$
957,730
$
( 1,051,360
)
$
( 93,621
)
Shares issued for vested restricted stock units
71
—
—
—
—
Share-based compensation
—
—
2,062
—
2,062
Net loss
—
—
—
( 49,021
)
( 49,021
)
Balance, March 31, 2022
8,669
$
9
$
959,792
$
( 1,100,381
)
$
( 140,580
)
The accompanying notes are an integral part of these condensed consolidated financial statements.
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TherapeuticsMD, Inc. and Subsidiaries
Condensed Consolidated Statements of Cash Flow
s
(Unaudited – in thousands)
Three Months Ended March 31,
2023
2022
Cash flows from operating activities:
Net loss
$
( 3,603
)
$
( 49,021
)
Less: Loss from discontinued operations, net of tax
1,293
31,146
Net income (loss) from continuing operations
( 2,310
)
( 17,875
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
27
329
Write-off
of patents and trademarks
59
—
Share-based compensation
483
2,061
Other
( 60
)
( 7
)
Changes in operating assets and liabilities:
Other assets
( 19
)
—
Prepaid and other current assets
( 1,453
)
1,052
Accounts payable
164
( 502
)
Accrued expenses and other current liabilities
( 4,486
)
( 2,930
)
Other non-current
liabilities
( 1,106
)
—
Total adjustments
( 6,391
)
3
Net cash used in continuing operating activities
( 8,701
)
( 17,872
)
Cash flows from investing activities:
Payment of patent related costs
—
( 170
)
Purchase of fixed assets
—
( 42
)
Net cash used in continuing investing activities
—
( 212
)
Cash flows from financing activities:
Repayments of debt
—
( 5,000
)
Net cash used in continuing financing activities
—
( 5,000
)
Discontinued operations:
Net cash used in operating activities
( 24,474
)
( 11,654
)
Net cash provided by financing activities
1,106
—
Net cash used in discontinued operations
( 23,368
)
( 11,654
)
Net (decrease) increase in cash
( 32,069
)
( 34,738
)
Cash and restricted cash – continuing operations, beginning of period
49,317
65,122
Cash and restricted cash – discontinued operations, beginning of period
—
—
Total cash and restricted cash, end of period
$
17,248
$
30,384
Supplemental disclosure of cash flow information:
Interest paid
$
—
$
5,364
Supplemental disclosure of noncash financing activities:
Paid in kind (“PIK”) debt financing fees with corresponding increase in debt
$
—
$
30,000
The accompanying notes are an integral part of these condensed consolidated financial statements.
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TherapeuticsMD, Inc. and Subsidiaries
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
1. Business, basis of presentation, new accounting standards and summary of significant accounting policies
General
TherapeuticsMD, Inc. (the “Company”), a Nevada corporation, and its condensed
consolidated subsidiaries are referred to collectively in this Quarterly Report on Form 10-Q
(“10-Q
Report”) as “TherapeuticsMD,” “we,” “our” and “us.” This 10-Q
Report includes trademarks, trade names and service marks, such as TherapeuticsMD ®
, vitaMedMD ®
, BocaGreenMD ®
, vitaCare TM
, IMVEXXY ®
, BIJUVA ®
and ANNOVERA ®
, which
are protected under applicable intellectual property laws and are the property of, or licensed by or to, us. Solely for convenience, trademarks, trade names and service marks referred to in this 10-Q
Report may appear without the ®
, 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.
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. 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. 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, pursuant to 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.
Pursuant to a License Agreement, dated December 4, 2022, between TherapeuticsMD and Mayne Pharma (the “Mayne License Agreement”), we 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.
Pursuant to the Mayne License Agreement, Mayne Pharma will pay us milestone payments 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. Further, Mayne Pharma will pay us royalties on net sales of all Products in the United States at a royalty rate of 8.0 % on the first $ 80.0 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. 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. Mayne Pharma will pay us minimal annual royalties of $ 3.0 million per year for 12 years,
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adjusted for inflation at an annual rate of 3 %, subject to certain further adjustments, including as described below. 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.
Pursuant to a Transaction Agreement, dated December 4, 2022, between TherapeuticsMD and Mayne Pharma (the “Transaction Agreement”), we sold to Mayne Pharma, at closing, certain assets for Mayne Pharma to commercialize the Products in the United States, including, with the Population Council’s consent, our exclusive license from the Population Council to commercialize ANNOVERA (the “Transferred Assets”).
The total consideration from Mayne Pharma to TherapeuticsMD 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 Mayne License Agreement, as amended. 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.
On the Closing Date, TherapeuticsMD and Mayne Pharma entered into Amendment No. 1 to the Mayne License Agreement (the “Mayne License Agreement Amendment”). Pursuant to the Mayne License Agreement Amendment, Mayne Pharma agreed to pay 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 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. 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.
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. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in our condensed consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in Note 2 of our condensed consolidated financial statements.
We also have 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. (“Knight”) pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel.
•
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. In 2021, Theramex secured regulatory approval for BIJUVA in certain European countries and began commercialization efforts in those countries.
In connection with our transformation into a pharmaceutical royalty company, the termination of our executive management team (except for Mr. Marlan Walker, our former General Counsel and current Chief Executive
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Officer) and all other employees was completed by December 31, 2022. 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. As of December 31, 2022 and March 31, 2023, we employed one
full-time employee primarily engaged in an executive position. 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.
vitaCare Divestiture
On April 14, 2022, we completed the divestiture of our former subsidiary vitaCare Prescription Services, Inc. (“vitaCare”) with the sale of all of vitaCare’s issued and outstanding capital stock (the “vitaCare Divestiture”). We received net proceeds of $ 142.6 million, after deducting
transaction costs of $ 7.2 million, and we recognized a gain on sale of business of $ 143.4 million. 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. Additionally, the vitaCare Divestiture provides that 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, 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.
The Purchase Agreement contains customary representations and warranties, covenants, and indemnities of the parties thereto. The commitments under a long-term services agreement related to vitaCare were transferred to Mayne Pharma as part of the Mayne Transaction. 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.
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 three months ended March 31, 2023 and 2022.
COVID-19
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.
As of the date of issuance of these condensed 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.
Going concern
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 our exclusive license to commercialize ANNOVERA in the United States and its possessions and territories, and (iii) sell certain other assets to Mayne Pharma.
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The total consideration from Mayne Pharma to TherapeuticsMD for the purchase of the Transferred Assets and the grant of the licenses under the Mayne License Agreement consisted of (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 Mayne License Agreement Amendment and (iv) the right to receive the contingent consideration set forth in the Mayne License Agreement, as amended.
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 our subsidiaries party thereto from time to time as guarantors (the “Financing Agreement”) and the Financing Agreement was terminated.
Following the transaction with Mayne Pharma, our primary source of revenue is from royalties on products licensed to pharmaceutical organizations that possess commercial capabilities in the relevant territories. We may need to raise additional capital to provide additional liquidity to fund our operations until we become cash flow positive. 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. 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.
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
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. The potential impact of these factors in conjunction with the uncertainty of the capital markets raises substantial doubt about our ability to continue as a going concern for the next twelve months from the issuance of these financial statements.
The accompanying condensed consolidated financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.
Basis of presentation
We prepared the condensed consolidated financial statements included in this 10-Q
Report following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting principles generally accepted in the U.S. (“U.S. GAAP”) for complete financial statements can be condensed or omitted. However, except as disclosed herein, there has been no material change in the information disclosed in the notes included in our 2022 Annual Report on Form 10-K
(the “2022 10-K
Report”).
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
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assets and liabilities of discontinued operations in the condensed consolidated balance sheet. Additional disclosures regarding discontinued operations are provided in Note 2 of the condensed consolidated financial statements.
Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these interim financial statements may not be representative of those for the full year. 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. The information included in this 10-Q
Report should be read in conjunction with the condensed consolidated financial statements and accompanying notes included in our 2022 10-K
Report. Certain amounts in the condensed consolidated financial statements and accompanying notes may not add due to rounding, and all percentages have been calculated using unrounded amounts.
New accounting standards
Adoption of new accounting standards
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.
Common stock reverse stock split
On May 6, 2022, we completed a reverse stock split of our common stock, par value $ 0.001 per share (our “Common Stock”). As a result, shares of our outstanding 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. 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. 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 to the Reverse Stock Split. 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 to the Reverse Stock Split. Pursuant to Section 78.209 of the Nevada Revised Statutes, the approval of our stockholders was not required for our Board of Directors to effectuate the Reverse Stock Split.
All historical numbers of shares of Common Stock and per share data have been adjusted to give effect to the Reverse Stock Split. 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.
Estimates and assumptions
The preparation of our condensed consolidated financial statements in conformity to U.S. 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. We evaluate our estimated 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. Actual results may differ, at times in material amounts, from these estimates under different assumptions or conditions.
Significant accounting policies
The significant accounting policies we use for quarterly financial reporting are disclosed in Note 1 of the accompanying notes to the condensed consolidated financial statements included in our 2022 10-K
report and in the section below.
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2. Discontinued Operations
As discussed in Note 1, we changed our business in 2022 by licensing our products to receive royalties and future sales related milestone payments, after granting an exclusive license to commercialize our IMVEXXY, BIJUVA, and prescription prenatal vitamin products sold under the BocaGreenMD and vitaMedMD brands in the United States and assigning our exclusive license to commercialize ANNOVERA to Mayne Pharma.
This plan represented a strategic shift having a major effect on our operations and financial results. Upon the completion of our restructuring and ultimate 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. We have no t allocated any amounts for shared general and administrative operating support expense to discontinued operations. As required by the terms of the 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).
Additionally, the related assets and liabilities have been reported as assets and liabilities of discontinued operations in our condensed consolidated balance sheets as of March 31, 3023 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.
Our estimate 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. The determination of net working capital includes significant estimates which could change materially for a period of up to two years following the Closing Date. On March 29, 2023, we received Mayne Pharma’s closing net working capital calculation which differed significantly from our estimate of closing net working capital. 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. 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. 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.
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The following table presents results of discontinued operations (in thousands):
Three months ended March, 31
2023
2022
Product revenue, net
$
—
$
18,638
Cost of goods sold
—
4,165
Gross profit (loss)
—
14,473
Operating expenses:
Selling and marketing
—
18,895
General and administrative
335
2,515
Research and development
—
1,400
Depreciation and amortization
—
17
Total operating expenses
335
22,827
Operating profit (loss) from discontinued operations
( 335
)
( 8,354
)
Other income (expense), net
( 958
)
( 22,792
)
Total other income (expense), net
( 958
)
( 22,792
)
Net income (loss) from discontinued operations
$
( 1,293
)
$
( 31,146
)
The following table presents the carrying amounts of the classes of assets and liabilities of discontinued operations as of March 31, 2023 and December 31, 2022 (in thousands):
March 31, 2023
December 31, 2022
Liabilities:
Current liabilities:
Accounts payable
$
828
$
12,243
Accrued expenses and other current liabilities
1,822
13,588
Total current liabilities
$
2,650
$
25,831
3. Prepaid and other current assets
Our prepaid and other current assets consisted of the following as of March 31, 2023 and December 31, 2022 (in thousands):
March 31, 2023
December 31, 2022
Insurance
$
1,608
$
1,167
Capitalized legal
2,334
2,334
Other
1,504
2,533
Prepaid and other current assets
$
5,446
$
6,034
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4. Fixed assets
Our fixed assets, net consisted of the following as of March 31, 2023 and December 31, 2022 (in thousands):
March 31, 2023
December 31, 2022
Furniture and fixtures
$
931
$
931
Computer and office equipment
1,167
1,168
Computer software
375
375
Leasehold improvements
49
49
Fixed assets
2,522
2,523
Less: accumulated depreciation and amortization
2,464
2,445
Fixed assets, net
$
58
$
78
We recorded, in continuing operations, depreciation expense of $ 0.0 million and $ 0.1 million for the three months ended March 31, 2023 and 2022, respectively.
5. Licensed rights and other intangible assets
The following provides information about our license rights and other intangible assets, net as of March 31, 2023 and December 31, 2022 (in thousands):
March 31, 2023
December 31, 2022
Gross
Carrrying
Amount
Accumulated
Amortization
Net
Gross
Carrrying
Amount
Accumulated
Amortization
Net
Intangible assets subject to amortization:
Hormone therapy drug patents
$
6,224
$
1,604
$
4,620
$
6,225
$
1,598
$
4,627
Hormone therapy drug patents applied and pending approval
1,936
—
1,936
1,995
—
1,995
Intangible assets subject to amortization
8,160
1,604
6,556
8,220
1,598
6,622
Intangible assets not subject to amortization:
Trademarks/trade name rights
321
—
321
321
—
321
License rights and other intangible assets, net
$
8,481
$
1,604
$
6,877
$
8,541
$
1,598
$
6,943
We recorded, in continuing operations, amortization expense related to patents of $ 0.0 million and $ 0.2 million respectively, for the three months ended March 31, 2023 and 2022.
Our intangible assets subject to amortization are expected to be amortized as follows (in thousands):
Year ending
December 31,
2023
$
337
2024
439
2025
438
2026
438
2027
438
Thereafter
2,530
Total
$
4,620
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6. Accrued expenses and other current liabilities
Other accrued expenses and other current liabilities consisted of the following (in thousands):
March 31, 2023
December 31, 2022
Payroll and related costs
$
3,822
$
8,748
Accrued contract termination costs
5,078
4,700
Research and development expenses
—
978
Professional fees
623
415
Operating lease liabilities
1,441
1,390
Prepaid royalty
1,061
1,011
Other accrued expenses and current liabilities
2,335
1,604
Accrued expenses and other current liabilities
$
14,360
$
18,846
7. Commitments and contingencies
Mayne Pharma Agreement
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 is subject to certain adjustments for a period of up to two years following the Closing Date.
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. 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. We received 0.1 million in royalty payments from Mayne Pharma during the three months ended March 31, 2023.
Population Council License Agreement
Under the terms of our license agreement with the Population Council, Inc. (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 N
ew D
rug A
ppli c
ation (“NDA”) for ANNOVERA, and $ 20.0 million in 2019 following the first commercial batch release of ANNOVERA. The aggregate $ 40.0 million of milestone payments were recorded as license rights. The Population Council was also eligible to receive future payments upon the achievement of certain commercial sales milestones of ANNOVERA. On December 30, 2
022, we assigned the ANNOVERA license to Mayne Pharma. Our rights and obligations under the Population Council License Agreement have been transferred to Mayne Pharma and may revert back to us upon the occurrence of certain events.
Legal proceedings
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. (“Teva”). 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. In the IMVEXXY Notice Letter, Teva alleges that TherapeuticsMD patents listed in the FDA’s Orange Book that claim compositions and methods of IMVEXXY
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(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. In April 2020, we filed a complaint for patent infringement against Teva in the United States District Court for the District of New Jersey arising from Teva’s ANDA filing with the FDA. 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. Teva has filed its answer and counterclaim to the complaint, alleging that the IMVEXXY Patents are invalid and not infringed. 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. 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. We have incurred and recorded legal costs amounting to $ 0.1 million in prepaid expenses and other current assets as of March 31, 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. 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 the FDA by Amneal Pharmaceuticals (“Amneal”). In April 2020, we filed a complaint for patent infringement against Amneal in the United States District Court for the District of New Jersey arising from Amneal’s ANDA filing with the FDA. In December 2021, we entered into a settlement agreement (the “Settlement Agreement”) with Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals, LLC and Amneal Pharmaceuticals of New York LLC (collectively “Amneal”) to resolve the litigation over our patents listed in the FDA’s Orange Book that claim compositions and methods of BIJUVA (the “BIJUVA Patents”). Under the terms of the Settlement Agreement, the parties filed a consent judgment with the U.S. District Court for the District of New Jersey that enjoins Amneal from marketing a generic version of BIJUVA (1 mg estradiol and 100 mg progesterone) before the expiration of the patents-in-suit,
except as provided in the Settlement Agreement, and we granted Amneal a non-exclusive,
non-transferable,
royalty-free license to commercialize Amneal’s generic formulation of BIJUVA in the U.S. 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.
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.
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 condensed consolidated financial condition, results of operations, or cash flows.
Compliance with Nasdaq’s continued listing requirements
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. The Notice had
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no immediate effect on the listing of our Common Stock. We did not hold an annual meeting of stockholders during 2022 due to our then ongoing strategic processes.
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. We timely submitted such plan, and Nasdaq granted us an extension until June 29, 2023, to regain compliance. We have announced an annual meeting of stockholders to be held on June 26, 2023 which we expect will cause us to fully regain compliance with all applicable Nasdaq listing standards.
Off-balance
sheet arrangements
As of March 31, 2023 and December 31, 2022 we had no off-balance
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.
Employment agreements
In connection with our transformation into a pharmaceutical royalty company, the termination of our executive management team (except for Mr. Marlan Walker, our former General Counsel and current Chief Executive Officer) and all other employees was completed by December 30, 2022. Severance obligations for all employees other than executive officers were paid in full in the first quarter of 2023. As of March 31, 2023, we employ one full-time employee primarily engaged in an executive position. 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. 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. In the aggregate, as of March 31, 2023, we have accrued severance liabilities for executive termination obligations of $ 3.5 million.
8. Stockholders’ equity (deficit)
Warrants
As of March 31, 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
Weighted Average
Exercise Price
Aggregate
Intrinsic Value
Weighted Average
Remaining Contractual
Life (in Years)
As of January 1, 202 3
536
$
13.10
$
2,427
9.3
Exercised
( 310
)
Expired
( 2
)
As of March 31, 2023
225
$
31.26
$
467
8.5
Share-based compensation payment plans
As of March 31, 2023, 559,661 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). If we assume the maximum achievement of performance goals for PSUs, then 591,661 shares of common stock will be subject to outstanding awards under our share-based payment award plans and inducement grants. As of March 31, 2023, 300,232 shares of common stock were available for future grants of share-based payment awards under the TherapeuticsMD, Inc. 2019 Stock Incentive Plan.
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The following table summarizes the status of our outstanding and exercisable options and related transactions (each adjusted to account for the Reverse Stock Split) since December 31, 2022 (in thousands, except weighed average exercise price and weighted average remaining contractual life data):
Outstanding
Exercisable
Options
Awards
Weighted
Average
Exercise
Price
Aggregate
Intrinsic
Value
Weighted
Average
Remaining
Contractual
Life
(in Years)
Options
Awards
Weighted
Average
Exercise
Price
Aggregate
Intrinsic
Value
Weighted
Average
Remaining
Contractual
Life
(in Years)
As of January 1, 2023
172
$
228.28
—
3.6
170
$
229.43
—
3.6
Granted
—
—
—
—
—
—
Exercised
—
—
—
—
—
—
Cancelled/Forfeited
—
—
—
—
Expired
( 69
)
219.07
( 69
)
219.07
As of March 31, 2023
103
$
234.32
—
2.7
101
$
236.66
—
2.7
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
RSUs awards vested and not settled
RSUs
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
RSUs
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
As of January 1, 2023
246
$
29.64
$
1,376
189
$
26.28
$
1,059
Granted
120
5.12
50
5.12
Vested and settled
( 189
)
26.28
( 1,559
)
( 189
)
26.28
( 1,559
)
Cancelled/Forfeited
—
—
—
—
As of March 31, 2023
177
$
8.15
$
663
53
$
6.85
$
199
The following table summarizes the status of our PSU 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):
Outstanding
Vested and not settled
PSUs
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
PSUs
Weighted
Average
Grant Date
Fair Value
Aggregate
Intrinsic
Value
As of January 1, 2023
100
$
42.30
$
558
81
$
39.95
$
450
Granted
—
—
—
—
`
Vested and settled
( 81
)
39.95
450
( 81
)
39.95
450
Cancelled/Forfeited
—
—
—
—
As of March 31, 2023
19
(1)
$
52.15
$
72
5
$
56.05
$
19
(1)
The number of PSUs represents the base number of PSUs that will vest.
Share-based payment compensation cost
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. We recorded share-based payment award
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compensation costs related to previously issued options, RSU and PSUs, as well as shares of common stock issued under our ESPP totaling $ 0.5 million and $ 2.1 million for the three months ended March 31, 2023 and 2022 respectively.
As of March 31, 2023, we had $ 0.8 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.
The unrecognized compensation cost as of March 31, 2023, of $ 0.8 million is expected to be recognized as share-based payment award compensation over a weighted average period of 1.1 years.
9. Revenue
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.
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. 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. 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. 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. 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.
10. Income taxes
We do not expect to pay any significant federal or state income taxes as a result of (i) the losses recorded during the three months ended March 31, 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.
We recorded a full valuation allowance of the net operating losses for the three months ended March 31, 2023 and 2022. Accordingly, there were no provisions for income taxes for the three months ended March 31, 2023 and 2022. Additionally, as of March 31, 2023 and December 31, 2022, we maintain a full valuation allowance for all deferred tax assets.
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11. 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):
Three Months Ended March 31,
2023
2022
Numerator:
Net income (loss) from continuing operations
$
( 2,310
)
$
( 17,875
)
Net income (loss) from discontinued operations
( 1,293
)
( 31,146
)
Net loss
$
( 3,603
)
$
( 49,021
)
Denominator:
Weighted average common shares for basic loss per common share
9,754
8,614
Effect of dilutive securities
—
—
Weighted average common shares for diluted loss per common share
$
9,754
$
8,614
Income (loss) per common share, continuing operations
Basic
$
( 0.24
)
$
( 2.08
)
Diluted
( 0.24
)
( 2.08
)
Income (loss) per common share, discontinued operations
Basic
$
( 0.13
)
$
( 3.62
)
Diluted
( 0.13
)
( 3.62
)
Since we reported a net loss for the three months ended March 31, 2023 and 2022, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities. Therefore, our basic and diluted loss per common share and our basic and diluted weighted average common share are the same for the three months ended March 31, 2023 and 2022.
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 three months ended March 31, 2023 and 2022 (in thousands):
As of March 31,
2023
2022
Stock options
103
316
RSUs
177
339
PSUs
19
176
Warrants
225
103
524
934
12. Related parties
On August 23, 2022, we appointed Mr. Justin Roberts as a director to fill a newly created vacancy on our Board of Directors. Mr. Roberts will serve until our 2023 Annual Meeting of Stockholders or until his successor is duly elected or appointed or his earlier death or resignation and has been nominated for reelection at the 2023 Annual Meeting of Stockholders. As a director of our Company, Mr. 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. 1 to Form
10-K
for the fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission on May 1, 2023, but he has elected not to receive any compensation for his service as a
non-employee
director at this time. Mr. Roberts currently serves as a Partner of Rubric Capital Management LP (“Rubric”). On July 29, 2022, September 30, 2022, October 28, 2022 and
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May 1, 2023, we entered into subscription agreements with Rubric. On December 30, 2022, in accordance with the terms of the Certificate of Designation, we redeemed all 29,000 outstanding shares of Series A Preferred Stock previously issued to affiliates of Rubric at a purchase price of
$ 1,333 per share. We 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.
13. Business concentrations
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. 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. 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. Assets and liabilities associated with the commercial business are classified as assets and liabilities of discontinued operations in our condensed consolidated balance sheets. Additional disclosures regarding discontinued operations are provided in Note 2.
For the three months ended March 31, 2023, 100 % of
license revenue related to Mayne Pharma and Theramex.
As of March 31, 2023, we had a royalty receivable of $ 2.0 million relating to the short-term portion of receivable from Mayne Pharma and Theramex
and $ 20.3 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. As of March 31, 2023, we also recorded $ 1.1 million in prepaid royalties that we received from Mayne Pharma which were recorded in accrued expenses and other current liabilities.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.