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TherapeuticsMD, Inc. (NASDAQ: TXMD) reported its financial results for 2022, highlighting a significant turnaround with a net income of $1.1 million ($0.12 per share), compared to a net loss of $79.3 million in 2021. This improvement is attributed to increased licensing revenues from its exclusive agreement with Mayne Pharma, which amounted to $70 million in 2022, a steep rise from just $2.6 million the previous year. Operating expenses decreased to $67.4 million from $80.7 million in 2021, reflecting cost-cutting measures following the transaction with Mayne Pharma. However, cash reserves fell to $38.1 million from $64.9 million year-over-year. The company eliminated debt totaling $188.3 million after the Mayne Pharma deal, while also redeeming preferred stock. Future outlook remains focused on streamlining operations and potentially creating value through additional strategic initiatives.
Dr. Reddy's Laboratories SA, a wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd., has signed a definitive agreement to acquire the U.S. generic prescription product portfolio from Mayne Pharma Group Limited for approximately $90 million in cash. The portfolio includes 45 commercial products, 4 pipeline products, and 40 approved non-marketed products, with a total revenue of $111 million reported for the last financial year. This acquisition aims to enhance Dr. Reddy’s presence in the women’s health market and accelerate access to affordable medications.
Catalent has announced its acquisition of Metrics Contract Services for $475 million from Mayne Pharma, aiming to enhance its capabilities in oral solid formulation development and manufacturing. The acquisition includes Metrics' 333,000 square-foot facility in Greenville, North Carolina, featuring significant investment in upgrades and the capacity to produce over one billion oral solid dose units annually. This strategic move will allow Catalent to meet growing customer demands in the biopharma sector.
Mayne Pharma Group and Mithra Pharmaceuticals announced that NEXTSTELLIS®, a contraceptive pill containing the new estrogen estetrol and progestin drospirenone, has been nominated for the 2022 Prix Galien USA Award for Best Pharmaceutical Agent. NEXTSTELLIS® is the first contraceptive in over 60 years to utilize estetrol, which is derived from a plant source. The Prix Galien Awards recognize outstanding pharmaceutical innovations and are set for October 2022. NEXTSTELLIS® has shown safety and efficacy in phase 3 trials, with a strong focus on women's health.
Mayne Pharma has entered a strategic agreement with GoodRx to enhance awareness and access to NEXTSTELLIS®, a contraceptive pill, through a direct-to-consumer program in the U.S. This collaboration aims to leverage GoodRx's extensive reach to inform consumers and healthcare providers. Launched in July 2022, the initiative is designed to educate women on their contraceptive options and promote NEXTSTELLIS®, which is noted as the fastest-growing branded contraceptive in 2022.
Mayne Pharma announced that the FDA has approved LEXETTE (halobetasol propionate) foam, 0.05% for use in adolescents aged 12 and older for treating plaque psoriasis. This super potent topical corticosteroid was initially approved in 2018 and has shown effective results in clinical studies involving 560 patients. Psoriasis affects around 8 million Americans, with plaque psoriasis being the most common form. The foam formulation enhances patient compliance, promising a safe treatment option for young patients.
Mayne Pharma Group Limited (ASX: MYX) announced the launch of a generic version of ORTHO-CEPT® (desogestrel and ethinyl estradiol) in the US. This is their fourth oral contraceptive launch this year, following LOESTRIN® 24 FE, ORTHO CYCLEN®, and ORTHO TRI-CYCLEN®. Combined, these products represent a US market value of approximately US$315 million as of January 2021. The company also has four women’s health products pending FDA approval, including NEXTSTELLIS™, potentially introducing a new estrogen to the market for the first time in 50 years.
