Endo International PLC

Endo International Plc operates as a pharmaceutical company, which engages in the development, manufacture, and distribution of branded and generic pharmaceutical products. It operates through the following segments: Branded Pharmaceuticals, Sterile Injectables, Generic Pharmaceuticals and International Pharmaceuticals. The Branded Pharmaceuticals segment conducts certain operations in the U.S. through leased and owned manufacturing properties in Pennsylvania, New York and New Jersey, as well as certain administrative and R&D functions through leased properties in Pennsylvania. The Sterile Injectables segment includes manufacturing, quality assurance, research and development, and administration functions. The Generic Pharmaceuticals segment is composed of manufacturing, distribution, quality assurance and administration functions, as well as certain research and development functions. The International Pharmaceuticals segment’s operations are currently conducted through Paladin’s leased headquarters in Montreal, Canada. The company was founded in 1997 and is headquartered Dublin, Ireland.

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Endo Health Solutions Inc. provides specialty healthcare solutions in the United States and internationally. The company’s Endo Pharmaceuticals segment offers branded prescription products,.

DUBLIN , June 15, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping dexlansoprazole 30 mg capsules, a generic version of Takeda's Dexilant®. This additional dosage strength rounds out the product family, now with both 30 mg and 60 mg delayed-release capsules.

Endo Launches Dexlansoprazole Capsules, Generic Version of Dexilant®

The ready-to-use pre-filled syringe combines two well-known, FDA-approved products in a standard concentration ratio Product eliminates the need for two discrete syringe preparations and administrations, which helps increase efficiency for hospitals and healthcare providers DUBLIN , June 12, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that its Par Sterile Products business has begun shipping PREVDUO™ (neostigmine methylsulfate and glycopyrrolate injection) pre-filled syringe, the first and only FDA-approved neostigmine–glycopyrrolate combination product in the U.S. "This is the latest way we're addressing operational and clinical challenges in order to support patient care," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "With two medications in one ready-to-use syringe, PREVDUO™ reduces complexity and increases efficiency for hospitals and healthcare providers.

Endo Launches PREVDUO™ (neostigmine methylsulfate and glycopyrrolate injection), the First and Only FDA-Approved Neostigmine-Glycopyrrolate Combination Pre-Filled Syringe

DUBLIN , June 5, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that post-hoc data from two Phase 3 studies of XIAFLEX® (collagenase clostridium histolyticum, or CCH, injection 0.9 mg) in treating men with Peyronie's disease (PD) were published by peer-reviewed journal Urology®. Read the article here.

Endo Announces Publication of XIAFLEX® (collagenase clostridium histolyticum) Data Analysis in Peer-Reviewed Urology®

Only ready-to-use (RTU) liquid format of bivalirudin expected to begin shipping in summer 2023 RTU bivalirudin injection  does not require reconstitution, dilution or mixing, which helps increase efficiency for hospitals and healthcare providers DUBLIN , May 24, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that its subsidiary Endo Ventures Limited has executed an agreement with MAIA Pharmaceuticals, Inc. to distribute bivalirudin injection in a ready-to-use 250 mg/50 mL single-use vial in the U.S. Endo will commercialize the FDA-approved product through its Par Sterile Products business and expects to begin shipping in summer 2023. "Hospital providers have told us what they need—ready-to-use medications that allow them to focus on patients rather than preparation," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo.

Endo Announces Agreement with MAIA Pharmaceuticals to Distribute Bivalirudin Injection in Ready-to-Use Vials

DUBLIN , May 8, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) today reported financial results for the first-quarter ended March 31, 2023. FIRST-QUARTER FINANCIAL PERFORMANCE (in thousands, except per share amounts) Three Months Ended March 31, 2023 2022 Change Total Revenues, Net $         515,267 $         652,259 (21) % Reported Loss from Continuing Operations $            (2,823) $          (65,300) (96) % Reported Diluted Weighted Average Shares 235,216 233,879 1 % Reported Diluted Net Loss per Share from Continuing Operations $              (0.01) $              (0.28) (96) % Reported Net Loss $            (3,279) $          (71,974) (95) % Adjusted Income from Continuing Operations (2)(3) $         193,328 $         155,939 24 % Adjusted Diluted Weighted Average Shares (1)(2) 236,105 236,716 — % Adjusted Diluted Net Income per Share from Continuing Operations (2)(3) $               0.82 $               0.66 24 % Adjusted EBITDA (2)(3) $         209,030 $         310,926 (33) % __________ (1) Reported Diluted Net Loss per Share from Continuing Operations is computed based on weighted average shares outstanding and, if there is income from continuing operations during the period, the dilutive impact of ordinary share equivalents outstanding during the period.

ENDO REPORTS FIRST-QUARTER 2023 FINANCIAL RESULTS

DUBLIN , April 26, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that its subsidiaries Endo Ventures Limited and Par Pharmaceutical, Inc. (collectively "Endo") have executed an agreement with Slayback Pharma LLC to distribute Slayback's Prevduo™ (neostigmine methylsulfate and glycopyrrolate injection) pre-filled syringe on an exclusive basis in the U.S. The U.S. Food and Drug Administration (FDA) approved Prevduo™ in February 2023 for the reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery, while decreasing the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) associated with cholinesterase inhibition following NMBA reversal administration.

Endo Announces Agreement with Slayback Pharma to Distribute Prevduo™ (neostigmine methylsulfate and glycopyrrolate injection), the First and Only FDA-Approved Neostigmine-Glycopyrrolate Combination Product in the U.S.

DUBLIN , April 3, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping the authorized generic (AG) version of Merck's Noxafil® (posaconazole) 200 mg/5 mL oral suspension in the U.S. "Our partnership with Merck underscores our reputation as an industry-leading supplier," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. "This newly available Noxafil® AG dosage form is the latest addition to our generics portfolio—providing patient access to high-quality, lower-cost treatment options.

Endo Launches Authorized Generic Version of Noxafil® (posaconazole) Oral Suspension

DUBLIN , March 13, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) today announced top-line results from its Phase 2 clinical study of collagenase clostridium histolyticum (CCH) in participants with plantar fibromatosis. While the primary endpoint when analyzed with the overall study population did not meet statistical significance, a large patient sub-population showed statistically significant improvement.

Endo Provides Top-Line Results from Phase 2 Study of Collagenase Clostridium Histolyticum (CCH) in Participants With Plantar Fibromatosis

DUBLIN , March 10, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping the first generic version of Allergan's Pylera® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) 140 mg, 125 mg and 125 mg capsules in the U.S., following final approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application. "We're proud to be a reliable, quality supplier providing choices to healthcare professionals and their appropriate patients," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo.

Endo Launches First Generic Version of Pylera® (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) Capsules

DUBLIN , March 6, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) today reported financial results for the fourth-quarter ended December 31, 2022. FOURTH-QUARTER FINANCIAL PERFORMANCE (in thousands, except per share amounts) Three Months Ended December 31, Year Ended December 31, 2022 2021 Change 2022 2021 Change Total Revenues, Net $          555,812 $         789,429 (30) % $       2,318,875 $       2,993,206 (23) % Reported Loss from Continuing Operations $         (245,163) $        (556,667) (56) % $      (2,909,618) $         (569,081) NM Reported Diluted Weighted Average Shares 235,205 233,681 1 % 234,840 232,785 1 % Reported Diluted Net Loss per Share from Continuing Operations $               (1.04) $              (2.38) (56) % $             (12.39) $               (2.44) NM Reported Net Loss $         (243,535) $        (562,062) (57) % $      (2,923,105) $         (613,245) NM Adjusted Income from Continuing Operations (2)(3) $          189,529 $         179,914 5 % $          463,858 $          691,229 (33) % Adjusted Diluted Weighted Average Shares (1)(2) 236,500 237,045 — % 236,404 236,665 — % Adjusted Diluted Net Income per Share from Continuing Operations (2)(3) $                0.80 $               0.76 5 % $                1.96 $                2.92 (33) % Adjusted EBITDA (2)(3) $          210,102 $         366,404 (43) % $          892,050 $       1,455,702 (39) % __________ (1) Reported Diluted Net Loss per Share from Continuing Operations is computed based on weighted average shares outstanding and, if there is income from continuing operations during the period, the dilutive impact of ordinary share equivalents outstanding during the period.

ENDO REPORTS FOURTH-QUARTER 2022 FINANCIAL RESULTS

Campaign Speaks to Undiagnosed and Diagnosed "Internal Agonizers" -  Campaign tells men who are endlessly searching online for answers to stop typing and start talking to a specialized urologist about Peyronie's disease -  Commercial and ads address men's embarrassment, reluctance and fear in talking about their symptoms and seeking treatment DUBLIN , Feb. 6, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today the launch of the "Man With a Plan" campaign, which aims to motivate men who may have symptoms of Peyronie's disease (PD) to go to MakeaPDplan.com to find a specialized urologist who can diagnose and treat them. PD is a men's health condition that is estimated to affect 1 in 10 men in the U.S.* and can lead to a curvature deformity of the penis when erect.

Endo Launches "Man With a Plan" Campaign to Support Men With Symptoms of Peyronie's Disease

DUBLIN , Dec. 6, 2022 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that it will cease the production and sale of Endo Aesthetics' Qwo® (collagenase clostridium histolyticum-aaes) in light of market concerns about the extent and variability of bruising following initial treatment as well as the potential for prolonged skin discoloration. For more than a year, Endo worked to address those concerns, including launching an open-label study in June 2022, APHRODITE, to test different interventions and whether they might mitigate bruising.

Endo to Cease Production and Sale of Qwo® (collagenase clostridium histolyticum-aaes)

DUBLIN , Nov. 9, 2022 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) today reported financial results for the third-quarter ended September 30, 2022. THIRD-QUARTER FINANCIAL PERFORMANCE (in thousands, except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 Change 2022 2021 Change Total Revenues, Net $         541,690 $         772,028 (30) % $     1,763,063 $      2,203,777 (20) % Reported Loss from Continuing Operations $        (718,272) $          (49,289) NM $    (2,664,455) $          (12,414) NM Reported Diluted Weighted Average Shares 235,160 233,578 1 % 234,719 232,487 1 % Reported Diluted Net Loss per Share from Continuing Operations $              (3.05) $              (0.21) NM $            (11.35) $              (0.05) NM Reported Net Loss $        (722,169) $          (77,207) NM $     (2,679,570) $          (51,183) NM Adjusted Income from Continuing Operations (2)(3) $          111,858 $         189,277 (41) % $         274,329 $         511,315 (46) % Adjusted Diluted Weighted Average Shares (1)(2) 236,183 235,527 — % 236,372 236,538 — % Adjusted Diluted Net Income per Share from Continuing Operations (2)(3) $                0.47 $               0.80 (41) % $               1.16 $               2.16 (46) % Adjusted EBITDA (2)(3) $          210,816 $         386,883 (46) % $         681,948 $      1,089,298 (37) % __________ (1) Reported Diluted Net Loss per Share from Continuing Operations is computed based on weighted average shares outstanding and, if there is income from continuing operations during the period, the dilutive impact of ordinary share equivalents outstanding during the period.

ENDO REPORTS THIRD-QUARTER 2022 FINANCIAL RESULTS

Men Can Document Their Penile Curvature, Complete a Self-Assessment Questionnaire, Learn About Peyronie's Disease and Find a Provider Through the App -  Peyronie's Disease assessment and educational features are meant to empower men with knowledge of the condition and an understanding of their own penile curvature -  App to be unveiled to urologists / sexual medicine specialists and presented as an oral presentation at the 23rd Annual Fall Scientific Meeting of SMSNA DUBLIN and BURNSVILLE, Minn. , Oct. 27, 2022 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) and the Sexual Medicine Society of North America (SMSNA) announced today the launch of a Peyronie's Self-Assessment application, available now in the App Store and Google Play.

Endo and SMSNA Launch App to Provide Peyronie's Disease Self-Assessment Tool

DUBLIN , Oct. 7, 2022 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that data from studies of Endo Aesthetics' Qwo® (collagenase clostridium histolyticum-aaes), an FDA-approved injectable for the treatment of moderate to severe cellulite in the buttocks of adult women, will be presented during the American Society for Dermatologic Surgery annual meeting, taking place now through October 10 in Denver, CO. The five new and modified oral presentations are below: NEW: Durability of Collagenase Clostridium Histolyticum-aaes Treatment of Buttock Cellulite in Women: Open-Label Extension Study Results Through 3 Years Authors: Michael H.

Endo Presents New Qwo® (collagenase clostridium histolyticum-aaes) Data at the American Society for Dermatologic Surgery's Annual Meeting

Real Patients Talk About the Hand Condition and Treatments Six short, unscripted "Coffee & Cords" videos explore various topics, including the tabletop test, finding a hand specialist and discussing treatment options Videos can be seen online, with digital and social advertising to come later this year DUBLIN , Oct. 5, 2022 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today the launch of its new branded video series, Coffee & Cords , which aims to educate people about Dupuytren's contracture (DC), a progressive hand condition that results in the formation of a collagen rope-like cord that pulls fingers toward the palm and affects an estimated 14 million Americans. The Coffee & Cords videos feature five real patients with DC in a coffee shop discussing their experiences with the finger contracture condition, including the impact on their daily activities and treatment options.

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