Endo Inc - NDOI STOCK NEWS

Endo (OTCQX: NDOI) has launched 'Steve's Journey,' its first branded TV commercial for XIAFLEX®, the only FDA-approved nonsurgical treatment for Dupuytren's contracture. The campaign features a real patient, Steve, and his wife Gisele, sharing their experience with the progressive hand condition that affects an estimated 17 million Americans.

The commercial showcases Steve's treatment journey with XIAFLEX® and demonstrates how the treatment helped him regain hand functionality for everyday activities. The 60-second spot will air across various platforms, including news, sports programming, popular TV series, cable channels, and streaming services.

The campaign builds on Endo's research showing that many patients delay treatment due to concerns about surgery. According to company data, patients who ask for XIAFLEX® by name receive the medication more than half of the time.

Endo (OTCQX: NDOI) has launched 'I Got Somebody,' a new television commercial and disease awareness campaign focused on Peyronie's disease (PD). The campaign directs men to GoGetSomebody.com to find urology specialists who can diagnose and offer treatment plans, including nonsurgical options.

PD, which affects an estimated 1 in 10 men in the U.S., is a condition where scar tissue causes a curve with a bump in the penis when erect. The campaign addresses research showing men often delay seeking treatment due to embarrassment and fear.

The commercial will run nationally on major networks like ESPN, ABC, NBC, and Fox Sports 1, streaming services including Hulu, Amazon, and Peacock, and through social media channels. The campaign showcases how men readily share recommendations for various problems and encourages them to do the same with PD-related healthcare concerns.

Endo (OTCQX: NDOI) announced the publication of their Peyronie's disease (PD) self-assessment screening app in the peer-reviewed journal Translational Andrology and Urology. The app aims to help men document curvature deformities and prepare for urologist visits, addressing the reluctance many face in discussing this intimate condition. The application features include image scans, a self-assessment questionnaire, and a provider locator. The article was authored by healthcare professionals including Gregory A. Broderick, MD, Jesse N. Mills, MD, Lisa Bathish, BA, PMP, Christopher Davis, PMP, and Mohit Khera, MD, MBA, MPH.

Endo (OTCQX: NDOI) has received FDA approval for commercial production of VASOSTRICT® at its new 20,000-square-foot aseptic manufacturing facility in Indore, India. This marks the facility's first FDA approval, expanding the company's sterile injectable production capacity.

The facility, specifically designed for aseptic manufacturing of sterile injectable products, will initially produce medicines in vials with future capabilities for syringe production. Production is estimated to begin in 2026, and Endo plans to seek additional product approvals for the site.

Endo has launched ADRENALIN® ready-to-use premixed bag, marking the first and only FDA-approved, manufacturer-prepared epinephrine premixed IV bag. This innovative product, part of the TruDelivery® portfolio, offers improved workflow efficiency and reduced medication error risks. The premixed bag requires no compounding or preparation, features single-port IV tubing, and maintains a 24-month shelf life at room temperature. ADRENALIN® is indicated for treating hypotension associated with septic shock.

Endo (OTCQX: NDOI) announced that NFL legend John Elway will provide an update about his experience with XIAFLEX® treatment for Dupuytren's contracture from five years ago. Elway, who partnered with Endo in 2019 for a disease education campaign, will speak to media outlets on November 20, 2024, about his patient journey and current hand health. He reports feeling early signs of the condition in another finger and plans to seek XIAFLEX treatment again. The company notes that Elway's involvement has successfully raised awareness about Dupuytren's contracture among patients and hand specialists.

Endo USA (OTCQX: NDOI) is expanding its voluntary recall of Clonazepam Orally Disintegrating Tablets due to potential carton strength mislabeling caused by a third-party packager error. The recall affects multiple lots of various strengths (0.125mg, 0.25mg, 1mg, and 2mg). While blister strips and tablets contain correct strengths, cartons may display incorrect strength and NDC codes. This mislabeling poses risks of adverse effects including sedation, confusion, and potentially life-threatening respiratory depression. No adverse events have been reported. The company is notifying distributors and retailers to stop distribution and return existing inventory through Inmar, Inc.

Endo has signed a definitive agreement with MC2 Therapeutics to commercialize Wynzora® Cream (calcipotriene and betamethasone dipropionate) in Canada through its subsidiary Paladin Pharma. The cream, designed to treat plaque psoriasis, is pending Health Canada approval. The product has already received FDA approval in July 2020 and was launched in Europe in February 2022. This agreement aims to expand the availability of Wynzora® Cream's unique formulation to Canadian patients, offering a new treatment option designed for convenient daily use.

Endo reported Q3 2024 financial results with total revenues of $427 million, down 6% year-over-year. The XIAFLEX® franchise grew 13% to $128 million, while the company experienced declines in Sterile Injectables (-16%) and Generic Pharmaceuticals (-18%). Net loss was $233 million compared to $28 million in Q3 2023. Adjusted EBITDA increased 6% to $151 million, driven by reduced operating costs and improved margins. The company reaffirmed its 2024 financial guidance with expected total revenues of $1,720-$1,780 million and Adjusted EBITDA of $635-$655 million.