Latest news with #TherapeuticsMD
News.com.au
21-05-2025
- Business
- News.com.au
Health Check: Mayne Pharma shares tumble after suitor threatens to walk over ‘adverse events'
Cosette Pharmaceuticals' $600 million tilt at Mayne Pharma is in peril Analysts back Monash IVF after earnings update EBR Systems launches $55 million capital raising Investors have birched shares in takeover target Mayne Pharma (ASX:MYX) after the company today revealed a dispute with its suitor over what constitutes an 'adverse material change' to the business. Mayne shares are now trading almost 40% lower than Cosette Pharmaceuticals' $7.40 a share offer price, which suggests little hope of the bid being executed on current terms. According to Mayne, a note from Cosette notice refers to the 'circumstances associated' with Mayne's April 22 earnings update, 'previously disclosed' litigation with TherapeuticsMD over a licensing deal and 'certain correspondence' with regulators. The latter refers to the US Food & Drug Administration (FDA) accusing Mayne of misrepresenting the safety risks of its contraceptive pill, Nextstellis. Cosette alleges Mayne failed to consult on the adverse changes in good faith for 10 business days, as required under the scheme implementation deed. Mayne contends there was nothing to consult about, in that the matters outlined 'did not establish the pre-requisites for a material adverse change.' It's always a case of 'he said, she said' in marital disputes, innit? Cosette says the consultation obligations are 'enlivened' and the bidder intends to comply with them. But failing a 'satisfactory outcome', it will walk. Mayne holders were due to vote on the scheme of arrangement on June 18, but probably can wash their hair or walk the dog instead. EBR goes to the well for up to $55 million Shares in heart device pioneer EBR Systems (ASX:EBR) have entered trading halt, pending a $50 million placement and $5 million share purchase plan. Arranged by Morgans and Wilsons, the deal is being done at $1 a share – an 18% discount to the frozen price. On April 11 EBR won FDA approval for its Wise device, the world's first and only leadless tool for left ventricular endocardial pacing. The funds will be used to commercialise Wise, with the company estimating the initial market opportunity at US$3.6 billion a year. EBR faces no rival products, while Wise can be used alongside existing right-hand leadless pacemakers. EBR held $84.5 million of cash as at the end of March. Post raising this cash swells to $125 million, which should provide a runway until the September quarter next year. EBR shares have lost 28% since the company-making FDA approval, reflecting investor expectations of a raising. Echo IQ tries again for US reimbursement Still on matters of the heart, Echo IQ (ASX:EIQ) shares this morning bounced up to 16%, having lost one third of their value before a trading halt was imposed on Monday. The company requested the halt after hearing that the American Medical Association (AMA) had declined to provide a specific reimbursement code for its heart tool. Echo Solv AS. These codes are essential for billing because they provide a standardised language for reporting medical procedures and services to insurance companies and other payors. Echo Solv AS evaluates aortic stenosis non-invasively, based on data from an echocardiogram. This use should have justified a specific reimbursement code, but for some reason the AMA's relevant panel declined to provide one. The setback doesn't look to be the end of the world, in that the company can submit a new code change application that addresses deficiencies the panel identified. 'The company understands it is not uncommon for applications to be rejected initially, and it is confident it can strengthen its application to be able to meet the criteria.' Unsurprisingly, EchoIQ plans to do so. The company today said while reimbursement strategy remains a priority, the company was 'advancing the deployment' of Echo Solv AS with large hospital groups and other US strategic partners. It's also working on an FDA application for a second product, Echo Solv AF. Echo IQ shares fell by one third on Monday, ahead of a 1.25 pm trading halt. This freeze should have been requested at the start of the day, but an administrative glitch prevented this from happening. Monash IVF is due for a baby bounce Monash IVF Group (ASX:MVF) is poised for a 'reset' following last month's baby-switching snafu and yesterday's earnings downgrade, according to analysts. Management revised full-year underlying profit expectations by 10%, to $27.5 million. Tellingly, the company cited generally soft conditions rather than the Brisbane 'incident' that resulted in two mothers receiving the wrong embryos. The company has commissioned an independent review, led by prominent barrister Fiona McLeod SC, to recommend improvements. Broker Morgans opines the downgrade 'resets the base' for the company, which will continue to benefit from the industry's fundamental growth. Post the baby bungle revealed on April 11, Monash IVF has not seen any change in patient registration or transfer levels. 'We think this is positive, though the lack of news around the outcome of the independent review … will continue to weigh on the stock.' Macquarie Equities expects Monash IVF to lose share of both fresh and frozen cycles, but cites 'structural headwinds' including the increasing age of new mothers and rising levels of male infertility. Morgans cites a $1 valuation. Despite its more caution tone Macquarie ascribed a 12 month 'price target' of $1.30 to the shares, 75% higher than their current worth. It's no dream as Compumedics inks $1 million sleep sale Compumedics' (ASX:CMP) push into the US sleep testing market has had a boost, with a contract research organisation buying US$600,000 ($1 million) of the company's Somfit devices. Compumedics says the sale shows that Somfit is relevant not just for the capacious US home testing market, but adjacent markets such as testing new drugs for their effect on sleep before being approved. The sale takes US orders so far this year to US$12 million, 130% better than a year ago. Meanwhile, management affirms guidance of full-year sales revenue of $50-55 million, with underlying earnings of around $3 million. Founded in Melbourne in 1987, the company carries out a broad range of brain and sleep monitoring globally.
Reuters
21-05-2025
- Business
- Reuters
Mayne Pharma slumps 30% as Cosette threatens to scrap $432 million deal
May 21 (Reuters) - Shares of Mayne Pharma ( opens new tab plunged 30% on Wednesday after U.S.-based Cosette Pharmaceuticals initiated a review of its A$672 million ($432.1 million) acquisition, citing a "material adverse change" in the Australian firm's business and finances. Shares of Mayne Pharma, a dermatology and women's health company, were down 30.3%, as of 0108 GMT, and on course for their worst day since early-March 2009, if losses hold. Under the February agreement, Cosette's acquisition of Mayne is subject to a "material adverse change" condition, allowing the deal to collapse if significant negative developments impact Mayne's financial health, business, or outlook. Cosette did not immediately respond to a request for comment outside of business hours. The Bridgewater, New Jersey-headquartered pharmaceutical products manufacturer has indicated that Mayne's trading performance, including its nine-month earnings update, legal case with TherapeuticsMD, and its recent talks with the U.S. Food and Drug Administration (FDA) constitute the "adverse change". Last month, Mayne received an FDA letter concerning promotional claims made about its oral contraceptive, Nextstellis. Cosette's claim triggers a mandatory 10-business-day consultation period with Mayne to discuss the change in good faith. Cosette has indicated that it will issue a notice to terminate the deal if the consultation process fails to reach a satisfactory outcome, Mayne said in a statement on Wednesday. Mayne, which rejected the issues raised in the Cosette notice, said it remains open to talks to resolve the matter. ($1 = 1.5552 Australian dollars)
Washington Post
13-05-2025
- Business
- Washington Post
TherapeuticsMD: Q1 Earnings Snapshot
BOCA RATON, Fla. — BOCA RATON, Fla. — TherapeuticsMD Inc. (TXMD) on Tuesday reported a loss of $653,000 in its first quarter. The Boca Raton, Florida-based company said it had a loss of 6 cents per share. The woman's health care product company posted revenue of $393,000 in the period. _____
Business Wire
13-05-2025
- Business
- Business Wire
TherapeuticsMD Announces First Quarter 2025 Financial Results
BOCA RATON, Fla.--(BUSINESS WIRE)--TherapeuticsMD, Inc. ('TherapeuticsMD' or the 'Company') (NASDAQ: TXMD), a company that owns rights to pharmaceutical royalties, today reported financial results for the three months ended March 31, 2025. First Quarter 2025 Financial Results Net Loss from Continuing Operations Net loss from continuing operations was $(636) thousand, or $(0.06) per basic and diluted common share, a decrease of $99 thousand, compared to net loss from continuing operations of $(809) thousand, or $(0.07) per basic and diluted common share, for the first quarter of 2024. License Revenues from Continuing Operations License revenue, primarily from the Mayne License Agreement, totaled $393 thousand for the first quarter ended March 31, 2025, an increase of $80 thousand, or 25.8%, compared to $313 thousand in license revenue for the three months ended March 31, 2024. The increase is primarily attributable to changes in sales of licensed products. Total Operating Expenses from Continuing Operations Total operating expenses for the first quarter of 2025 were $1,264 thousand, a decrease of $191 thousand, or 13.1%, compared to the first quarter of 2024. The change is due to the increased efficiencies realized as a royalty-based business. Evaluation of Strategic Alternatives The Company continues to evaluate a variety of strategic alternatives that may include, but not be limited to, an acquisition, merger, other business combination, sale of assets, or other strategic transactions involving the Company. Although the Company is exploring potential strategic alternatives, there can be no assurance of a transaction, a successful outcome of these efforts, or the form or timing of any such outcome. The Company has not set a timetable for completion of this exploration process and does not intend to disclose further developments unless and until it is determined that disclosure is appropriate or necessary. Balance Sheet As of March 31, 2025, the Company's cash and cash equivalents totaled $5.7 million. About TherapeuticsMD TherapeuticsMD was previously a women's healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause. In December 2022, the Company changed its business to become a pharmaceutical royalty company, primarily collecting royalties from its licensees. The Company is no longer engaging in research and development or commercial operations. 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, including the exploration of potential strategic alternatives that may include, but are not limited to, an acquisition, merger, other business combination, sale of assets, or other strategic transactions, and the completion of such a review process 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's licensees will be successful at commercializing the products that they licensed and acquired from TherapeuticsMD; whether the company is successful in winding down its operations and the costs associated therewith, including the company's ability to obtain any additional financing necessary therefor and any adjustments to the net working capital purchased as part of the Mayne Pharma transaction; whether the company is successful in identifying strategic pathways to create additional shareholder value; the outcome of the company's disputes with Mayne Pharma; the company's ability to remain listed on Nasdaq; the impact of product liability lawsuits; the impact of leadership transitions; the impact of Mayne Pharma Group's agreement to be acquired by Cosette Pharmaceuticals, Inc. and the volatility of the trading price of the company's common stock.
