TherapeuticsMD, Inc. - TXMD STOCK NEWS

TherapeuticsMD, Inc. (NASDAQ: TXMD) announced the submission of a supplemental New Drug Application (sNDA) for low-dose BIJUVA (estradiol and progesterone) capsules to the FDA. The company anticipates receiving acceptance notification within approximately 74 days, with a potential review period of ten months. BIJUVA is already approved for moderate to severe vasomotor symptoms due to menopause. The CEO expressed optimism about the new dosage providing additional therapeutic options for women.

TherapeuticsMD, Inc. (NASDAQ: TXMD) reported a 60% increase in net product revenue for Q1 2021, totaling $19.6 million, compared to Q1 2020. The performance was driven by strong sales of ANNOVERA, which saw revenues rise to $8.8 million, and BIJUVA, which grew by 120% to $2.5 million. The company also secured three new patents for ANNOVERA, extending exclusivity to June 2039. Despite a 13% decline in revenue from Q4 2020, the overall outlook remains positive with a continuous improvement in financial performance.

TherapeuticsMD (NASDAQ: TXMD) has presented Phase 3 data for ANNOVERA, its FDA-approved contraceptive, showcasing favorable menstrual bleeding profiles at the 2021 ACOG Annual Meeting. The analysis included data from 2,070 women over 453,622 patient-days, indicating 94.8% to 97.6% reported no unscheduled bleeding across 13 cycles. Discontinuation due to bleeding-related issues was under 2%. ANNOVERA offers a long-lasting, patient-controlled contraceptive option but comes with significant risk warnings, particularly for women over 35 who smoke.

TherapeuticsMD, Inc. (NASDAQ: TXMD), a leader in women’s healthcare, will report Q1 2021 financial results on May 6, 2021, before U.S. market opening. Following this, an executive management conference call and webcast is scheduled for 8:30 a.m. ET to discuss the results and provide a business update. Investors can access the call via telephone or through a live audio webcast on the company's website. Replays will be available for 30 days. TherapeuticsMD specializes in products for family planning, reproductive health, and menopause management.

TherapeuticsMD, Inc. (NASDAQ: TXMD) and Theramex announced the approval of BIJUVE^® in the UK and BIJUVA^® in Belgium by respective regulatory agencies. This approval follows a decentralized procedure completed in February for several EU countries. Both medications represent the first oral combined hormone replacement therapy utilizing bio-identical hormones for post-menopausal women. Theramex will pay milestone and royalty fees to TherapeuticsMD based on sales and approvals in Europe.

TherapeuticsMD reported record net product revenue for Q4 2020 and the full year, driven by strong sales of its products. Total revenue for Q4 was $22.6 million, a rise from $15.9 million in Q4 2019. The company recorded a net loss of $42.1 million for Q4, an improvement from $49.4 million a year earlier. Operating expenses increased to $51.6 million in Q4, mainly attributed to ongoing product launches and brand management. The cash on hand at year-end was $80.5 million. The company is adjusting its revenue covenants and plans further debt repayments in 2021.

TherapeuticsMD, Inc. (NASDAQ: TXMD) will participate in two upcoming investor conferences, showcasing its commitment to women’s healthcare. The first event is the Cowen Virtual Healthcare Conference on March 3, 2021, at 3:20 p.m. Eastern time. The second is the H.C. Wainwright Global Life Sciences Conference on March 9, 2021, with a presentation available at 11:00 a.m. Eastern time. Live webcasts can be accessed through the company’s website. TherapeuticsMD focuses on innovative products for women, addressing key health issues throughout their lives.

TherapeuticsMD, Inc. (NASDAQ: TXMD) has announced its fourth quarter 2020 financial results reporting on Tuesday, March 2, 2021, before U.S. market opening. The company will hold a conference call at 8:30 a.m. ET to discuss the results and provide a business update. Interested parties can access the call via telephone at 866-665-9531 for U.S. callers or 724-987-6977 for international calls, using access code 6184646. The event will also be available via a live audio webcast on their website.