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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DUBLIN , April 22, 2024 /PRNewswire/ -- Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is expanding its voluntary recall to include seven lots of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product solution.

Par Pharmaceutical Issues Voluntary Nationwide Recall of Seven Lots of Treprostinil Injection Due to Potential for Silicone Particulates in the Product Solution

DUBLIN , March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®. "We're proud to provide affordable choices to healthcare providers and their appropriate patients while strengthening our reputation as a reliable, quality supplier," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo.

Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS®

Endo International

Bankrupt drugmaker Endo International said on Tuesday a U.S. Bankruptcy Court has approved its restructuring plan and related opioid settlements to emerge from bankruptcy, which began in 2022.

Drugmaker Endo receives US court approval for bankruptcy restructuring

Anticipates Completing Financial Restructuring as Early as Late April 2024 DUBLIN , March 19, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) ("Endo" or the "Company") today announced that the United States Bankruptcy Court for the Southern District of New York has confirmed its Chapter 11 plan of reorganization (the "Plan"), clearing the path for the Company to successfully complete its financial restructuring.  Under the Plan, substantially all of the Company's assets are being sold to a new entity, Endo, Inc., over 95% of which is owned by holders of the Company's first lien debt.

Endo Announces Confirmation of Plan of Reorganization

DUBLIN , March 12, 2024 /PRNewswire/ -- Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product solution.

Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates in the Product Solution

DUBLIN , March 6, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) today reported financial results for the fourth-quarter ended December 31, 2023. FOURTH-QUARTER FINANCIAL PERFORMANCE (in thousands, except per share amounts) Three Months Ended December 31, Year Ended December 31, 2023 2022 Change 2023 2022 Change Total Revenues, Net $        497,734 $        555,812 (10) % $     2,011,518 $     2,318,875 (13) % Reported Loss from Continuing Operations $    (2,441,038) $       (245,163) NM $    (2,447,786) $    (2,909,618) (16) % Reported Diluted Weighted Average Shares 235,220 235,205 — % 235,219 234,840 — % Reported Diluted Net Loss per Share from Continuing Operations (1) $           (10.38) $             (1.04) NM $           (10.41) $           (12.39) (16) % Reported Net Loss $    (2,441,483) $       (243,535) NM $    (2,449,807) $    (2,923,105) (16) % Adjusted Income from Continuing Operations (2)(3) $        151,060 $        189,529 (20) % $        706,534 $        463,858 52 % Adjusted Diluted Weighted Average Shares (1)(2) 235,220 236,500 (1) % 235,441 236,404 — % Adjusted Diluted Net Income per Share from Continuing Operations (2)(3) $               0.64 $               0.80 (20) % $              3.00 $               1.96 53 % Adjusted EBITDA (2)(3) $         166,341 $         210,102 (21) % $        761,838 $         892,050 (15) % __________ (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 2023 FINANCIAL RESULTS

With This Resolution, Endo Prepares to Complete Its Financial Restructuring Positioned for Sustained Success DUBLIN , Feb. 29, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) ("Endo" or the "Company") today announced that its subsidiary, Endo Health Solutions Inc. ("EHSI"), has agreed to resolve all issues regarding previously disclosed U.S. Department of Justice ("DOJ") investigations of EHSI and other Company subsidiaries related to certain legacy marketing of Opana® ER. The Company voluntarily stopped marketing Opana® ER directly to U.S. healthcare providers in 2016 and stopped selling Opana® ER in 2017.

Endo Reaches Resolution with U.S. Department of Justice Regarding Legacy Marketing of Opana® ER

The U.S. Department of Justice said Thursday that it has reached a $465 million settlement with bankruptcy drugmaker Endo International, resolving the federal government's law enforcement, tax, and health care cost claims.

Drugmaker Endo reaches $465 mln bankruptcy settlement with US government

DUBLIN , Jan. 24, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that the peer-reviewed Journal of Hand Surgery Global Open published Collagenase Clostridium Histolyticum for the Treatment of Dupuytren Disease: A Delphi-Based Consensus Study.1 Consensus-based study findings among expert hand surgeons indicate that XIAFLEX® (collagenase clostridium histolyticum) has a wide-ranging application for the appropriate treatment of Dupuytren's contracture in patients with varying degrees of disease severity and functional impairment. Results from the published research indicate a high level of consensus for using XIAFLEX for the treatment of one- or two-finger metacarpophalangeal (MP) joint contractures, most one- or two-finger proximal interphalangeal (PIP) joint contractures, and most combined MP and PIP joint contractures.

Endo Announces Publication of New XIAFLEX® (collagenase clostridium histolyticum) Survey Data in Journal of Hand Surgery Global Open

MONTREAL , Jan. 22, 2024 /PRNewswire/ -- Paladin Labs Inc., a subsidiary of Endo International plc (OTC: ENDPQ), announced today that XCOPRI® (cenobamate tablets) is now available in Canada. XCOPRI is indicated as adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.

Endo's Paladin Labs Announces Launch of XCOPRI® (cenobamate tablets) in Canada

DUBLIN , Jan. 19, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that two new presentations related to Dupuytren's contracture and XIAFLEX® (collagenase clostridium histolyticum) were shared during the American Association for Hand Surgery (AAHS) annual meeting. Endo provided funding through an investigator-initiated research grant.

Endo Announces New Data for Dupuytren's Contracture Presented at the American Association for Hand Surgery Annual Meeting

Paves the Way for Endo to Successfully Conclude Financial Restructuring in Second Quarter of 2024 DUBLIN , Dec. 19, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) ("Endo" or the "Company") today announced that it has taken an important step toward concluding its financial restructuring process by filing a proposed Plan of Reorganization (the "Plan") and related Disclosure Statement with the U.S. Bankruptcy Court for the Southern District of New York (the "Court"). These filings pave the way for Endo to promptly emerge from Chapter 11 with a strengthened balance sheet and to advance its ongoing business transformation.

ENDO FILES PLAN OF REORGANIZATION TO IMPLEMENT PREVIOUSLY ANNOUNCED SALE TRANSACTION

"PD Pool Hall" Explores the Men's Health Condition Through Real Patients and Real Talk Unscripted videos feature real Peyronie's disease (PD) patients discussing their experiences while shooting pool Though PD is a relatively common condition, diagnosis rates remain low because men with PD may be uncomfortable to speak up and get help "PD Pool Hall" videos are available online now and through digital and social advertising beginning in December DUBLIN , Nov. 30, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today the launch of its new branded video series, PD Pool Hall, which aims to educate people about Peyronie's disease (PD), 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. The PD Pool Hall videos feature four real patients, both treated and untreated, in a pool hall discussing their experiences with PD, including the impact on their lives and their treatment journeys.

Endo Launches Unscripted Video Series With Real Peyronie's Disease Patients

DUBLIN , Nov. 6, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) today reported financial results for the third-quarter ended September 30, 2023. THIRD-QUARTER FINANCIAL PERFORMANCE (in thousands, except per share amounts) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 Change 2023 2022 Change Total Revenues, Net $        451,665 $        541,690 (17) % $     1,513,784 $     1,763,063 (14) % Reported Loss from Continuing Operations $         (27,936) $       (718,272) (96) % $           (6,748) $    (2,664,455) NM Reported Diluted Weighted Average Shares 235,220 235,160 — % 235,219 234,719 — % Reported Diluted Net Loss per Share from Continuing Operations $             (0.12) $             (3.05) (96) % $             (0.03) $           (11.35) NM Reported Net Loss $         (28,483) $       (722,169) (96) % $           (8,324) $    (2,679,570) NM Adjusted Income from Continuing Operations (2)(3) $        131,441 $        111,858 18 % $        555,474 $        274,329 NM Adjusted Diluted Weighted Average Shares (1)(2) 235,220 236,183 — % 235,515 236,372 — % Adjusted Diluted Net Income per Share from Continuing Operations (2)(3) $              0.56 $              0.47 19 % $              2.36 $              1.16 NM Adjusted EBITDA (2)(3) $        143,050 $        210,816 (32) % $        595,497 $        681,948 (13) % __________ (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 2023 FINANCIAL RESULTS

DUBLIN , Nov. 2, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping colchicine 0.6 mg capsules, a generic version of Hikma's MITIGARE®. This is the first generic colchicine capsule approved by the U.S. Food and Drug Administration.

Endo Launches Colchicine Capsules, Generic Version of MITIGARE®

DUBLIN , Sept. 21, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that data from clinical studies of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis will be presented during the American Orthopaedic Foot & Ankle Society's (AOFAS) annual scientific meeting.

Endo Presents New Data at the American Orthopaedic Foot & Ankle Society Annual Meeting

DUBLIN , Aug. 8, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) today reported financial results for the second-quarter ended June 30, 2023. SECOND-QUARTER FINANCIAL PERFORMANCE (in thousands, except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 Change 2023 2022 Change Total Revenues, Net $          546,852 $          569,114 (4) % $      1,062,119 $      1,221,373 (13) % Reported Income (Loss) from Continuing Operations $            24,011 $      (1,880,883) NM $           21,188 $     (1,946,183) NM Reported Diluted Weighted AverageShares 235,220 235,117 — % 235,662 234,498 — % Reported Diluted Net Income (Loss)per Share from Continuing Operations $                0.10 $               (8.00) NM $               0.09 $              (8.30) NM Reported Net Income (Loss) $            23,438 $      (1,885,427) NM $           20,159 $     (1,957,401) NM Adjusted Income from ContinuingOperations (2)(3) $          230,705 $              6,532 NM $         424,033 $         162,471 NM Adjusted Diluted Weighted Average Shares (1)(2) 235,220 236,217 — % 235,662 236,466 — % Adjusted Diluted Net Income per Share from Continuing Operations (2)(3) $                0.98 $                0.03 NM $               1.80 $               0.69 NM Adjusted EBITDA (2)(3) $          243,417 $          160,206 52 % $         452,447 $         471,132 (4) % __________ (1) Reported Diluted Net Income (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 SECOND-QUARTER 2023 FINANCIAL RESULTS

DUBLIN , July 20, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that the first patient has been enrolled in CURVE-PD (Clinical Understanding through Real-world data to Validate Effectiveness of treatments in Peyronie's disease), a non-interventional registry of up to 1,000 patients with Peyronie's disease (PD). This registry will create the largest and most comprehensive collection of real-world PD data on treatment outcomes.

Endo Announces First Patient Enrolled in Registry of Peyronie's Disease

Only ready-to-use liquid format of bivalirudin on the market Does not require reconstitution, dilution or mixing, which helps increase efficiency for hospitals and healthcare providers DUBLIN , July 18, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that its Par Sterile Products business has begun shipping bivalirudin injection in a ready-to-use 250 mg/50 mL single-use vial. It is the only ready-to-use liquid format of bivalirudin on the market in the U.S. "Hospital practitioners work hard to provide quality patient care while also meeting operational challenges," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo.

Endo Launches Bivalirudin Injection in Ready-to-Use Vials

Premier

Strategic effort aims to bring stable, quality supply to providers and enhanced pricing predictability for critical labor and delivery drug CHARLOTTE, N.C. and DUBLIN , July 17, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) and Premier, Inc. (NASDAQ: PINC) announced today that Endo's Par Sterile Products business will supply Pitocin® (oxytocin injection, USP) vials through Premier's ProvideGx® and PremierProRx® programs.

Endo and Premier, Inc. Collaborate to Address Pitocin® (oxytocin injection, USP) Shortage

DUBLIN , July 13, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that new data from a Phase 1 study of collagenase clostridium histolyticum (CCH) in patients with plantar fibromatosis will be presented during the American Podiatric Medical Association's (APMA) annual scientific meeting. The meeting is taking place now through July 16 in Nashville, Tenn.

Endo Presents New Data at the American Podiatric Medical Association Annual Meeting

DUBLIN , June 29, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that its Par Sterile Products business has begun shipping posaconazole injection (18 mg/mL), the first generic version of Merck's Noxafil® in the U.S., following final approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application. "We're pleased to provide choices to healthcare providers," said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo.

Endo Launches First Generic Version of Noxafil® (posaconazole) Injection

DUBLIN and MONTREAL , June 29, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that Paladin Labs Inc., an Endo operating company, received Health Canada's approval of XCOPRI™ (cenobamate tablets) for adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy. "Many adults with partial-onset seizures are not able to control their seizures, even with the availability of many anti-seizure medications," said Livio Di Francesco, Vice President & General Manager of Paladin Labs Inc. "Paladin is dedicated to addressing unmet medical needs, and we are proud to achieve this approval—a milestone in epilepsy treatment.

Endo Announces Approval of XCOPRI™ (cenobamate tablets) in Canada

DUBLIN , June 26, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that the first patient has been enrolled in GRASP-DC (Generating Real-world Ambispective data to Study Participant Treatment outcomes for Dupuytren's Contracture), a non-interventional registry of up to 1,000 patients with Dupuytren's contracture (DC). This registry will create the largest and most comprehensive collection of real-world DC data on treatment outcomes.

Endo Announces First Patient Enrolled in Registry of Dupuytren's Contracture

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.

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