ENDO INC - NDOI STOCK NEWS

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.

Endo has successfully completed the repricing of its $1.5 billion term loan due 2031. The new rate is Term SOFR plus 400 basis points, representing a 50 basis points reduction in the interest rate. This refinancing is expected to generate annual interest expense savings of approximately $8 million. The loan maturity and other terms remain substantially unchanged.

Endo announced seven new presentations related to Peyronie's disease (PD) and XIAFLEX® (collagenase clostridium histolyticum, or CCH) at the Sexual Medicine Society of North America (SMSNA) annual meeting, October 17-20, 2024. The presentations include:

1. A study on CCH treatment for ventral curvature PD
2. A survey on women's sexual health providers' awareness of PD
3. An analysis of the PD patient journey
4. A comparison of CCH to surgery for PD management
5. A study on a novel CCH protocol for PD non-responders
6. Research on CCH efficacy for atypical PD patients
7. An evaluation of CCH providers' practice patterns

Dr. Matthew Ziegelmann, a presenting author, emphasized the importance of these studies in improving understanding and treatment of PD.

Endo, Inc. (OTCQX: NDOI) has announced it will release its third-quarter 2024 financial results on November 5, 2024, before the market opens. The company's senior management team will host a conference call and live webcast for investors at 8:30 a.m. ET on the same day.

Investors can participate in the call by dialing 800-836-8184 (U.S. and Canada toll-free) or 646-357-8785 (outside the U.S.), or by joining the live webcast through the provided link. Participants are advised to join 10 minutes before the scheduled start time. A replay of the webcast will be available within 24 hours on the company's investor relations website.