TherapeuticsMD Announces Fourth Quarter 2021 Financial Results

About this update from Therapeuticsmd, Inc.

- Reached definitive agreement to fully divest vitaCare business unit enabling greater focus on achieving leadership position in women’s healthcare - - Amended credit terms with Sixth Street in support of a new capitalization plan - - Conference call scheduled for 8:30 a.m. ET today - BOCA RATON, Fla. --(BUSINESS WIRE)-- TherapeuticsMD, Inc. (“TXMD” or the “Company”) (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the fourth quarter ended December 31, 2021 . “We spent the past three months executing on four key priorities set forth last quarter, and today we announced that we have accomplished two of them. With the definitive agreement to fully divest our vitaCare business unit, TXMD will emerge as a more focused company aimed at empowering women of all ages through better and affordable healthcare. Amending our credit terms is, in our view, the most prudent way to achieve the necessary financial flexibility to complete the announced sale of vitaCare and ultimately refinance our existing credit facility,” said Hugh O’Dowd, CEO of TherapeuticsMD . “Demand for our flagship product, ANNOVERA®, continues to grow. We are working to ensure ample supply and drive towards uninterrupted access to this important contraceptive. We are excited about our future, and believe we are on a pathway towards serving women as they navigate their healthcare needs,” concluded O’Dowd. Fourth Quarter 2021 Financial Results and Business Highlights Three Months ended December 31 , 2021 2020 Product revenue: ANNOVERA $ 7,831 $ 9,084 IMVEXXY 6,667 8,820 BIJUVA 2,680 2,244 Prescription vitamin 1,500 2,430 Product revenue, net 18,678 22,578 License revenue — — Total revenue, net $ 18,678 $ 22,578 ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) ANNOVERA net product revenue of $7.8 million for the fourth quarter of 2021 decreased by $1.3 million compared to $9.1 million for the fourth quarter of 2020. Approximately 9,315 ANNOVERA prescriptions were dispensed to patients during the fourth quarter of 2021, an increase of 11% from the third quarter of 2021, and 57% from the fourth quarter of 2020. Over 10,750 healthcare providers (HCPs) prescribed ANNOVERA during the fourth quarter, of which nearly 1,300 were new writers. Growth in prescribers of approximately 119% over fourth quarter of 2020. IMVEXXY ® (estradiol vaginal inserts) IMVEXXY net product revenue of $6.7 million for the fourth quarter of 2021 decreased by $2.2 million compared to $8.8 million for the fourth quarter of 2020. Approximately 109,300 IMVEXXY prescriptions were dispensed to patients during the fourth quarter of 2021. BIJUVA ® (estradiol and progesterone) capsules BIJUVA net product revenue of $2.7 million for the fourth quarter of 2021 increased by $0.4 million compared to $2.2 million for the fourth quarter of 2020. BIJUVA net product revenue for the fourth quarter of 2021 includes $0.7 million of export sales through our international licensing and supply agreement with Theramex HQ UK Limited . Cost of Goods Sold and Gross Margin Cost of goods was $4.7 million with product gross margin of 75% for the fourth quarter of 2022 compared to $5.6 million with product gross margin of 75% for the fourth quarter of 2020. Operating Expense, Net Loss and Related Information Total operating expense of $49.3 million for the fourth quarter of 2021 decreased by $2.3 million compared to $51.6 million for the fourth quarter of 2020. Included in total operating expense for the fourth quarter of 2021 was $5.1 million of severance related expenses recorded for a former executive. Without the executive severance, operating expense for the fourth quarter of 2021 would have been $44.3 million , a decrease of $7.3 million compared to the fourth quarter of 2020. Net loss for the fourth quarter of 2021 was $43.0 million , or $0.10 per basic and diluted share, compared to net loss for the fourth quarter of 2020 of $42.1 million , or $0.15 per basic and diluted share. Without the executive severance, net loss for the fourth quarter of 2021 would have been $37.9 million , or $0.09 per basic and diluted share. Balance Sheet As of December 31, 2021 , the Company’s cash on hand totaled $65.1 million , compared with $80.5 million as of December 31, 2020 . For 2021, the Company received $184.1 million in net proceeds from its at-the-market and underwritten equity offerings. As of December 31, 2021 , the remaining outstanding principal amount under the Company’s Financing Agreement was $200.0 million , which reflects a repayment of $50.0 million of principal during 2021. Conference Call and Webcast Details TherapeuticsMD will host a conference call and live audio webcast today at 8:30 a.m. ET to discuss these financial results and provide a business update. Date: Thursday, March 10, 2022 Time: 8:30 a.m. ET Telephone Access (US): 866-665-9531 Telephone Access (International): 724-987-6977 Access Code for All Callers: 6988467 A live webcast and audio archive for the event may be accessed on the home page or from the “Investors & Media” section of the TherapeuticsMD website at www.therapeuticsmd.com . Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least 30 days. In addition, a digital recording of the conference call will be available for replay beginning two hours after the call's completion and for at least 30 days with the dial-in 855-859-2056 or international 404-537-3406 and Conference ID: 6988467. Please see the Full Prescribing Information, including indication and Boxed WARNING, for each TherapeuticsMD product as follows: IMVEXXY (estradiol vaginal inserts) at https://imvexxy.com/pi.pdf BIJUVA (estradiol and progesterone) capsules at https://www.bijuva.com/pi.pdf ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) at www.annovera.com/pi.pdf Forward-Looking Statements This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in the company’s filings with the Securities and Exchange Commission , including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the effects of the COVID-19 pandemic; whether the company will be able to successfully divest its vitaCare business and how the proceeds that may be generated by such divestiture will be utilized; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility and the company’s ability to refinance such facility; the effects of supply chain issues on the supply of the company’s products; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; whether the FDA will approve the manufacturing supplement for ANNOVERA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the impact of leadership transitions; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership. - Financial Statements to Follow - TherapeuticsMD, Inc. and Subsidiaries Consolidated Balance Sheets (In thousands, except per share data) As of December 31 , 2021 2020 Assets: Current assets: Cash $ 65,122 $ 80,486 Accounts receivable, net of allowance for credit losses of $1,334 and $1,118 as of December 31, 2021 and 2020, respectively 36,176 32,382 Inventory 7,622 7,993 Prepaid and other current assets 10,548 7,543 Total current assets 119,468 128,404 Fixed assets, net 1,199 1,942 License rights and other intangible assets, net 40,318 41,445 Right of use assets 8,234 9,566 Other non-current assets 253 253 Total assets $ 169,472 $ 181,610 Liabilities and stockholders' equity (deficit): Current liabilities: Current maturities of long-term debt $ 188,269 $ — Accounts payable 20,318 21,068 Accrued expenses and other current liabilities 44,304 38,170 Total current liabilities 252,891 59,238 Long-term debt, net — 237,698 Operating lease liabilities 8,063 8,675 Other non-current liabilities 2,139 — Total liabilities 263,093 305,611 Commitments and contingencies Stockholders' deficit: Preferred stock, par value $0.001 ; 10,000 shares authorized, none issued — — Common stock, par value $0.001 ; 600,000 shares authorized, 429,886 and 299,765issued and outstanding as of December 31, 2021 and 2020, respectively 430 300 Additional paid-in capital 957,309 754,644 Accumulated deficit (1,051,360 ) (878,945 ) Total stockholders' deficit (93,621 ) (124,001 ) Total liabilities and stockholders' deficit $ 169,472 $ 181,610 TherapeuticsMD, Inc. and Subsidiaries Consolidated Statements of Operations (Unaudited - in thousands, except per share data) Three Months ended December 31 , Year ended December 31 , 2021 2020 2021 2020 Revenue: Product revenue, net $ 18,678 $ 22,578 $ 85,780 $ 62,872 License revenue — — 1,171 2,000 Total revenue, net 18,678 22,578 86,951 64,872 Cost of goods sold 4,737 5,581 18,838 15,975 Gross profit 13,941 16,997 68,113 48,897 Operating expenses: Selling and marketing 22,002 25,996 108,195 117,052 General and administrative 25,911 23,214 92,602 76,954 Research and development 1,420 2,394 7,086 10,432 Total operating expenses 49,333 51,604 207,883 204,438 Loss from operations (35,392 ) (34,607 ) (139,770 ) (155,541 ) Other (expense) income: Interest expense and other financing costs (7,576 ) (7,612 ) (32,917 ) (28,581 ) Other income, net 8 132 272 598 Total other (expense), net (7,568 ) (7,480 ) (32,645 ) (27,983 ) Loss before income taxes (42,960 ) (42,087 ) (172,415 ) (183,524 ) Provision for income taxes — — — — Net loss $ (42,960 ) $ (42,087 ) $ (172,415 ) $ (183,524 ) Loss per common share, basic and diluted $ (0.10 ) $ (0.15 ) $ (0.43 ) $ (0.67 ) Weighted average common shares, basic and diluted 427,314 286,607 397,992 275,649 TherapeuticsMD, Inc. and Subsidiaries Consolidated Statements of Cash Flows (Unaudited - in thousands) Year ended December 31 , 2021 2020 Cash flows from operating activities: Net loss $ (172,415 ) $ (183,524 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 4,093 4,067 Charges to provision for doubtful accounts 533 238 Inventory charge 1,082 7,205 Debt financing fees 5,689 2,532 Share-based compensation 18,125 10,679 Other 720 2,673 Changes in operating assets and liabilities: Accounts receivable (4,327 ) (8,224 ) Inventory (711 ) (3,337 ) Prepaid and other current assets (3,005 ) 3,209 Accounts payable (750 ) 1,887 Accrued expenses and other current liabilities 6,134 2,904 Other non-current liabilities 2,139 220 Total adjustments 29,722 24,053 Net cash used in operating activities (142,693 ) (159,471 ) Cash flows from investing activities: Payment of patent related costs (2,189 ) (1,391 ) Purchase of fixed assets (34 ) (207 ) Net cash used in investing activities (2,223 ) (1,598 ) Cash flows from financing activities: Proceeds from sale of common stock, net of costs 184,115 31,703 Proceeds from exercise of options and warrants 322 272 Proceeds from sale of common stock related to employee stock purchase plan 233 — Repayments of debt (50,000 ) — Borrowings of debt — 50,000 Payment of debt financing fees (5,118 ) (1,250 ) Net cash provided by financing activities 129,552 80,725 Net increase in cash (15,364 ) (80,344 ) Cash, beginning of period 80,486 160,830 Cash, end of period $ 65,122 $ 80,486 Supplemental disclosure of cash flow information: Interest paid $ 25,068 $ 25,849 Supplemental disclosure of noncash financing activities: Warrants issued in relation to debt financing agreement $ — $ 7,668 View source version on businesswire.com : https://www.businesswire.com/news/home/20220309005929/en/ James D’Arecca Chief Financial Officer 561-961-1900 Lisa M. Wilson In-Site Communications, Inc. 212-452-2793 [email protected] Source: TherapeuticsMD, Inc.

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