STOCKS TELEGRAPH

Tag: TXMD STOCK

  • Multiple SEC Filings: TherapeuticsMD Inc. (TXMD) stock Falls After Hours

    On March 23, TherapeuticsMD Inc. (TXMD) submitted multiple filings with the U.S. Securities Exchange Commission. Consequently, the stock suffered a downfall in the after-hours session.

    During the regular session, the stock went up by 8.87% at its closing price of $0.4356. The volume of shares traded during the session was just above the average at 8.06 million against 7.76 million. In the following after-hours session, TXMD saw a reversal with a loss of 12.76%. Hence, the stock was trading at a price of $0.3800 per share in the after-hours while the volume of shares exchanged was 782.16K.

    The pharmaceutical company, TherapeuticsMD Inc. develops products for women. Currently, the company has a market capitalization of $170.01 million with its 424.93 million shares outstanding.

    TXMD’s SEC Filings

    On Wednesday, the company submitted three SEC filings: i) 10-K: Annual report for the year ending December 31, 2021; ii) POSASR: Post-effective Amendment to an automatic shelf registration statement; and iii) SC 13D/A: General statement of acquisition of beneficial ownership – amendment.

    Source: Uni of Utah

    Previously, on March 18, the company had filed a current report on Form 8-K regarding Nasdaq’s notification and certain changes in the company’s leadership. As per the filing, having failed to regain compliance with Nasdaq’s minimum bid requirement in the given period, TXMD has requested a hearing before Nasdaq’s hearing panel. Moreover, the company’s CFO and Principal Financial Officer James C. D’Arrecca will be resigning on April 1, 2022. Thus, VP-Finance & Chief Accounting Officer Michael C. Donegan will succeed Mr. D’Arrecca on an interim basis.

    Q4 2021 Financial Results

    On March 10, the company declared its financial results for the fourth quarter of 2021.

    In Q4 2021, TXMD generated net product revenue of $7.8 million for ANNOVERA, $6.7 million for IMVEXXY®, and $2.7 million for BIJUVA®.

    Furthermore, the company incurred a net loss of $43.0 million in Q4 2021, against $42.1 million in Q4 2020. Resultantly, the net loss per share was $0.10 and $0.15 in Q4 of 2021 and 2020 respectively.

    Additionally, the cost of goods was $4.7 million while the product gross margin was 75% in the quarter.

    The company ended the quarter with $65.1 million in cash on hand on December 31, 2021.

    TXMD’s Divestiture of vitaCare

    On March 7, TXMD announced its definitive agreement for divesting its vitaCare Prescriptions Services to GoodRx for $150 million in cash. The agreement also includes additional consideration of $7 million based upon vitaCare’s performance through 2023. The transaction is expected to close in Q2 2022.

  • FDA’s Response: TherapeuticsMD Inc. (TXMD) Plummets Further Aftermarket

    TherapeuticsMD Inc. (TXMD) stock extended losses by 5.41% aftermarket when the company announced FDA’s response. The FDA declined TXMD’s Annovera’s previously submitted sNDA.

    During regular trading, the stock lost 3.30% at a volume of 4.71 million, closing the session at $0.4510. Following the announcement, the stock plunged further down to reach $0.4266 in the after-hours at 431.79K shares.

    The current market capitalization of TXMD is $191.64 million with its 424.93 million outstanding shares.

    FDA’s Response to TXMD

    On December 10, the company announced the response of the FDA to some manufacturing testing limits for ANNOVERA. The company had previously submitted an sNDA with the FDA for this purpose. As per the announcement, FDA did not approve the company’s revisions in the sNDA. Further, the FDA requested additional information and also suggested some recommendations.

    TXMD’s Annovera is the only long-lasting, reversible, procedure-free birth control, approved in August 2018 by the FDA. The president of TXMD said in the announcement that Annovera’s supply will be continued under existing specifications. Furthermore, the company will continue working with the FDA regarding the revisions.

    U.S. Patent Litigation with Amneal

    Previously, TXMD announced the settlement of U.S. litigation for Bijuva® with Amenal, on December 08. As per the previous announcement, the company was under patent litigation with Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals, LLC, and Amneal Pharmaceuticals of New York LLC.

    According to the announcement, TXMD granted a license to Amneal for the commercialization of a generic version of Bijuva in the U.S. This will start on May 25, 2032, with earlier commencement under specific circumstances. Further, TXMD’s last patent for Bijuva with FDA is set to expire on November 21, 2032.

    In addition, this litigation was pending in the U.S. District Court for New Jersey District since the year 2020.

    TXMD’s Financials

    On November 11, TXMD announced its financial results for the third quarter of 2021. As per the Q3 of 2021, the total net products revenue was $25.4 million. This shows an increase of 41.1% from the year-ago quarter.

    Moreover, the company incurred a net loss of $47.4 million in the third quarter of 2021, against $32.6 million in Q3 of 2020. Consequently, the net loss per basic and diluted share was $011 in Q3 of 2021, against $0.12 in the year-ago quarter.

  • TherapeuticsMD Inc. (TXMD) stock soared in the pre-market trading session: here’s why

    TherapeuticsMD Inc. (TXMD) stock recently traded in the premarket at $1.57 which is an 18.94% rise. TXMD’s stock closed at $1.32 which is the same price to its prior session close thus a 0.00% change. The number of shares that exchanged hands in the day was 6.57 million. However, this was lower than the average daily volume of 17.1 million shares within the past 50 days. The volume in the past week was down by -1.49%. TXMD stock has risen by 47.67% in the last 12 months but shed -17.50%. In the last 3 months, it then gained 2.33%. Furthermore, the company’s current market share values at $493.52 million and its outstanding shares stood at 286.69 million.

    The recent positive movement of TXMD stock in the recent pre-market trading session has come adjacent to the press release by the Company announcing approval of its Hormone Replacement Therapy (HRT)

    TherapeuticsMD healthcare provides special care for women

    TherapeuticsMD, Inc. is a healthcare company which is focused towards the production of novel and unique products. These healthcare products are made specifically for women and innovation comes through the design and accordance with the unmet needs/challenges of women. The company looks at various experiences and stages of a woman’s life to keep in mind while designing these products especially for menopause, family planning and reproductive health.

    Approval of HRT capsule, BIJUVA® in UK and BIJUVE®in Belgium.

    TherapeuticsMDInc (TXMD) along with its collaborating partner Theramex announced the approval of BIJUVE® Capsules in the United Kingdom and under the trade name BIJUVA® in Belgium. Theramex is a global specialty pharmaceutical company and like TXMD stock it is dedicated to women’s health. Its vision is to be a lifetime partner for women and has a portfolio of contraceptive, fertility, menopause, and osteoporosis related products covered under established brand names.

    United Kingdom and Belgium are not the first countries where the Hormone Replacement Therapy has been released; USA had BIJUVA made commercially available in April 2019, while Canada and Israel have these commercially available as well. However BIJUVA is Europe’s first and only oral HRT with bio-identical hormones; specifically Estradiol and micronized Progesterone made available.

    Theramex signed an exclusive licensing and supply agreement with TherapeuticsMD Inc. in June 2019, to make BIJUVA available outside of these countries, especially in the European market. This agreement states Theramex paying TherapeuticsMD, certain royalties and milestone fees based upon aggregate net sales.

    The approval in European countries is a major positive move for TXMD stock

    The process of regulatory approval was a decentralized procedure that took place in February and afterwards each country has its own terms and conditions for medical approval. The approval for other significant EU countries will take place shorty, as expected by Theramex. It is possible to see a positive trend of TXMD stock maintain for longer period if commercial availability and approvals come further down the year.