ENDO INTL PLC ORD Stock Price, News & Analysis

Endo International plc (OTC: ENDPQ) announced a distribution agreement with Slayback Pharma LLC for Prevduo™, a pre-filled syringe combining neostigmine methylsulfate and glycopyrrolate, approved by the FDA in February 2023. This marks the first and only FDA-approved neostigmine-glycopyrrolate combination product in the U.S., aimed at reversing neuromuscular blocking agents' effects after surgery while minimizing side effects. Endo will launch Prevduo™ in June 2023 through its Par Sterile Products division. The partnership leverages Endo's expertise in commercializing injectable solutions to enhance patient care. Key benefits of Prevduo™ include reduced preparation time and decreased risk of errors, benefiting hospitals and healthcare providers.

Endo International plc (OTC: ENDPQ) has initiated shipments of argatroban injection to healthcare providers via Premier's Premier ProRx^® program as of April 17, 2023. This product addresses ongoing supply challenges in the market and is listed as an essential medication by the FDA. The manufacturing occurs at Endo's facility in Rochester, Michigan. This introduction marks the third product supplied to Premier's hospital clients, alongside Adrenalin, Vasostrict, and fluphenazine decanoate injection. The partnership aims to enhance drug supply reliability in the healthcare sector.

Endo International plc (OTC: ENDPQ) announced on April 3, 2023, that its subsidiary Par Pharmaceutical has begun shipping the authorized generic (AG) version of Merck's Noxafil® (posaconazole) 200 mg/5 mL oral suspension in the U.S. This product aims to enhance patient access to affordable treatment options. The launch is part of an exclusive supply agreement with Merck, which also included a similar version of Noxafil® delayed-release tablets introduced in 2019. Scott Sims, Senior VP at Endo, emphasized the company’s reputation as a top supplier in the industry.

Endo International (OTC: ENDPQ) announced results from its Phase 2 clinical study of collagenase clostridium histolyticum (CCH) for treating plantar fibromatosis. The primary endpoint was not statistically significant in the overall population, though a significant improvement was noted in a large sub-population. Key secondary endpoints showed positive results including improvements in nodule hardness. The CCH safety profile was consistent with prior studies, exhibiting mainly mild to moderate adverse events. The company aims to refine the Phase 3 study design, planning to initiate this pivotal program later in the year.

Endo International plc (OTC: ENDPQ) announced the launch of the first generic version of Allergan's Pylera^® in the U.S. after receiving FDA approval for its Abbreviated New Drug Application. This product, containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride, provides a lower-cost treatment option for Helicobacter pylori infection and duodenal ulcer disease. Pylera^® generated approximately $30 million in sales for the year ending December 31, 2022. Endo emphasizes its commitment to delivering quality healthcare solutions.

Endo International plc (OTC: ENDPQ) reported its financial performance for Q4 2022, revealing a 30% drop in total revenues to $555.8 million compared to Q4 2021. The company's loss from continuing operations decreased by 56% to $245.2 million, resulting in a diluted net loss per share of $1.04. Adjusted income from continuing operations rose 5% to $189.5 million, with adjusted EBITDA at $210.1 million, a 43% decrease year-over-year. Notably, the Sterile Injectables segment saw a 66% revenue decline due to increased generic competition. Endo also announced cessation of Qwo® production.

Endo International plc (OTC: ENDPQ) has launched the "Man With a Plan" campaign aimed at encouraging men with Peyronie's disease (PD) to seek medical advice from specialized urologists. The campaign addresses the embarrassment and reluctance men face regarding their symptoms, highlighting that PD affects approximately 1 in 10 men in the U.S. The initiative will span television, online, and social media platforms, as well as materials in doctors' offices. Endo's research indicates that men often wait years before seeking treatment, so the campaign aims to activate these individuals to prioritize their health.

Endo International announces the cessation of production and sale of its aesthetic treatment Qwo due to significant market concerns over bruising and prolonged skin discoloration. Despite efforts to address these issues through a study, results did not meet expectations. The decision leads to workforce reductions and is expected to save $50-$60 million annually. However, pre-tax restructuring charges of $235-$250 million are anticipated. Qwo remains an FDA-approved product, and practitioners can continue to use existing stock while having the option to return unused products for refunds.

Endo International plc (OTC: ENDPQ) reported a 30% decline in total revenues for Q3 2022, totaling $541.7 million compared to $772 million in Q3 2021. The company's reported loss from continuing operations surged to $718.3 million, resulting in a diluted net loss per share of $3.05, compared to $0.21 in the same quarter last year. Adjusted income also fell by 41% to $111.9 million. The company filed for Chapter 11 bankruptcy on August 16, 2022, to restructure its debt and address ongoing litigation, impacting financial stability and future guidance.