TherapeuticsMD Announces Fourth Quarter 2021 Financial Results

Rhea-AI Summary

TherapeuticsMD, Inc. (TXMD) has reached a definitive agreement to divest its vitaCare business unit, allowing the company to concentrate on women's healthcare. CEO Hugh O’Dowd stated this move supports their goal to empower women through affordable healthcare solutions. In Q4 2021, TXMD reported total revenue of $18.7 million, down from $22.6 million in Q4 2020, driven by decreased sales of ANNOVERA and IMVEXXY. Net loss for the quarter was $43 million, or $0.10 per share. The company amended credit terms to enhance financial flexibility. Conference call scheduled for 8:30 a.m. ET today.

Positive

• Divestiture of vitaCare to focus on women's healthcare.
• Increased ANNOVERA prescriptions dispensed by 57% compared to Q4 2020.
• Amended credit terms expected to improve financial flexibility.
• Decrease in total operating expenses by $2.3 million compared to Q4 2020.

Negative

• Total revenue decreased by 17% from Q4 2020 to Q4 2021.
• Net loss increased to $43 million in Q4 2021 from $42.1 million in Q4 2020.
• ANNOVERA revenue declined by $1.3 million year-over-year.

- 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 299,765 issued 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

lwilson@insitecony.com

Source: TherapeuticsMD, Inc.

FAQ

What is the latest news from TherapeuticsMD (TXMD) regarding its business operations?

TherapeuticsMD has finalized the divestiture of its vitaCare business unit to concentrate on its core women's healthcare offerings.

How did TherapeuticsMD (TXMD) perform in the fourth quarter of 2021?

In Q4 2021, TherapeuticsMD reported total revenue of $18.7 million and a net loss of $43 million, marking a decrease in revenue from the previous year.

What are the financial impacts of the vitaCare divestiture on TXMD?

The divestiture aims to enhance TXMD's focus on women's healthcare and improve financial flexibility through amended credit terms.

What is the prescription growth for ANNOVERA reported by TXMD?

TXMD reported a 57% increase in ANNOVERA prescriptions in Q4 2021 compared to Q4 2020.