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 third quarter ended September 30, 2022. “Our products continue to be adopted by healthcare providers and patients, and we continue to believe that they represent a significant opportunity. Our prescriber bases grew, and we added around 1,500 new prescribers for ANNOVERA and around 1,600 for IMVEXXY. Total quarterly prescriptions for both products remained relatively stable compared to the second quarter of 2022, and ANNOVERA’s total prescriptions grew 10% compared to the third quarter of 2021. While our third quarter 2022 net revenues declined $4.5 million compared with the prior year, through disciplined cost control measures, we were able to reduce our operating expenses by $22 million year-over-year,” said Mark Glickman, co-Interim-CEO of TherapeuticsMD. “During the quarter, we were able to move past the inventory issues we experienced in the first half of the year, and our wholesale network is now fully stocked. With these developments and the recent cash infusion from Rubric Capital, we believe our operations have stabilized, and we continue on our path forward toward our goal of meeting the demand for our products and helping to advance women’s health,” added Glickman. “Our Board of Directors and management team continue to actively assess strategic alternatives to strengthen the Company’s long-term financial position.” concluded Glickman. Third Quarter 2022 Financial Results and Business Highlights Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 $ 10,415 $ 11,807 $ 37,196 $ 30,112 6,947 8,016 20,583 24,866 2,663 3,298 7,877 7,899 892 1,335 2,671 4,162 20,917 24,456 68,327 67,039 — 950 484 1,234 $ 20,917 $ 25,406 $ 68,811 $ 68,273 ANNOVERA® (segesterone acetate and ethinyl estradiol vaginal system) ANNOVERA net product revenue of $10.4 million for the third quarter of 2022 decreased by $1.4 million compared to $11.8 million for the third quarter of 2021. Approximately 9,200 ANNOVERA prescriptions were dispensed to patients during the third quarter of 2022. Over 15,000 healthcare providers (HCPs) prescribed ANNOVERA since launch through the third quarter of 2022, of which more than 1,500 were new writers. IMVEXXY® (estradiol vaginal inserts) IMVEXXY net product revenue of $6.9 million for the third quarter of 2022 decreased by $1.1 million compared to $8.0 million for the third quarter of 2021. Approximately 91,300 IMVEXXY prescriptions were dispensed to patients during the third quarter of 2022. BIJUVA® (estradiol and progesterone) capsules BIJUVA net product revenue of $2.7 million for the third quarter of 2022 decreased by approximately $0.6 million compared to $3.3 million for the third quarter of 2021. BIJUVA net product revenue for the third quarter of 2022 includes $0.4 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 $3.8 million with product gross margin of 82% for the third quarter of 2022 compared to $5.3 million with product gross margin of 78% for the third quarter of 2021. The increase in product gross margins was mainly due to changes in product sales mix. Operating Expense, Net Loss and Related Information Total operating expense of $37.9 million for the third quarter of 2022 decreased by approximately $22.2 million compared to $60.0 million for the third quarter of 2021. Net loss for the third quarter of 2022 was $29.0 million, or $3.13 per basic and diluted share, compared to net loss for the third quarter of 2021 of $47.4 million, or $5.62 per basic and diluted share. Balance Sheet As of September 30, 2022, the Company’s cash on hand totaled $27.1 million, compared with $65.1 million as of December 31, 2021. Subsequent to quarter end, the Company closed a $7 million private investment in the Company’s Series A Preferred Stock from Rubric Capital Management LP. The Company also had $11.3 million in restricted cash related to customary holdbacks as part of the vitaCare Prescription Services divestiture. As of September 30, 2022, the Company’s aggregate balance of net debt, lender warrants derivative liability, make-whole payment derivative liability and mandatory redeemable preferred stock was $117.1 million. In light of the Company’s ongoing strategic alternatives process, the Company will not be hosting a conference call. 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: whether the company will be able to refinance the indebtedness under its term loan facility, and, if not, whether the company will be able to continue as a going concern; whether the company will be able to raise capital to fund its operations; whether and how the executive order on contraception is implemented; the effects of the COVID-19 pandemic; 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; 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; the company’s ability to protect its intellectual property; 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; and the volatility of the trading price of the company’s common stock. - Financial Statements to Follow - $ 27,080 $ 65,122 11,250 — 32,157 36,176 6,701 7,622 10,290 10,548 87,478 119,468 551 1,199 37,876 40,318 7,749 8,234 253 253 $ 133,907 $ 169,472 $ 93,602 $ 188,269 2,058 — 1,751 — 19,709 — 13,383 20,318 43,568 44,304 174,071 252,891 7,553 8,063 554 2,139 182,178 263,093 — — 9 9 968,785 957,730 (1,017,065 ) (1,051,360 ) (48,271 ) (93,621 ) $ 133,907 $ 169,472 Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 $ 20,917 $ 24,456 $ 68,327 $ 67,039 — 950 484 1,234 20,917 25,406 68,811 68,273 3,788 5,282 13,388 14,101 17,129 20,124 55,423 54,172 19,129 30,005 61,703 86,193 17,635 28,435 55,445 66,691 1,112 1,605 4,092 5,666 37,876 60,045 121,240 158,550 (20,747 ) (39,921 ) (65,817 ) (104,378 ) — — 143,384 — (3,457 ) — (3,457 ) — (76 ) — (76 ) — — — (8,380 ) — (4,833 ) (7,518 ) (30,941 ) (25,341 ) (112 ) 19 (128 ) 264 (8,478 ) (7,499 ) 100,402 (25,077 ) (29,225 ) (47,420 ) 34,585 (129,455 ) (260 ) — 290 — $ (28,965 ) $ (47,420 ) $ 34,295 $ (129,455 ) $ (3.13 ) $ (5.62 ) $ 3.86 $ (16.68 ) 9,261 8,444 8,877 7,762 $ (3.13 ) $ (5.62 ) $ 3.73 $ (16.68 ) 9,261 8,444 9,205 7,762 Nine Months Ended September 30, 2022 2021 $ 34,295 $ (129,455 ) 3,181 3,091 542 540 73 1,082 20,053 4,158 8,587 12,779 (143,384 ) — 3,457 — 8,380 — 50 726 3,044 (5,560 ) 848 (451 ) 180 (2,831 ) (6,186 ) (1,476 ) 3,705 13,504 (675 ) 758 (98,145 ) 26,320 (63,850 ) (103,135 ) 142,634 — (297 ) (675 ) (21 ) (34 ) 142,316 (709 ) 16,252 — 1,751 — 2,454 182,881 — 302 14 134 (125,000 ) (50,000 ) (729 ) (5,118 ) (105,258 ) 128,199 (26,792 ) 24,355 65,122 80,486 $ 38,330 $ 104,841 $ 8,371 $ 19,675 $ 2,452 $ — $ 16,980 $ — $ 1,983 $ —
