Amneal Pharmaceuticals

Amneal Reports First Quarter 2024 Financial Results

Retrieved on: 
Friday, May 3, 2024

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced its results today for the first quarter ended March 31, 2024.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced its results today for the first quarter ended March 31, 2024.
  • “We are extremely pleased with our outstanding start to the year, as Amneal generated record levels of revenues in the first quarter.
  • Net revenue in the first quarter of 2024 was $659 million, an increase of 18% compared to $558 million in the first quarter of 2023.
  • Adjusted diluted earnings per share in the first quarter of 2024 was $0.14 compared to $0.12 for the first quarter of 2023.

Amneal Launches PEMRYDI RTU®, the First Ready-to-Use Version of Important Oncology Injectable Medicine

Retrieved on: 
Tuesday, April 16, 2024

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the launch of PEMRYDI RTU®, the first and only ready-to-use presentation of pemetrexed for injection.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the launch of PEMRYDI RTU®, the first and only ready-to-use presentation of pemetrexed for injection.
  • This product does not require reconstitution, dilution, or refrigeration, which is different than other versions of pemetrexed for injection.
  • “The launch of PEMRYDI RTU highlights Amneal’s deep commitment to oncology as we invest to develop injectable products that are important to healthcare providers and patients,” said Sean McGowan, Vice President, Biosimilars and Branded Oncology.
  • PEMRYDI RTU® injectable is available in two vial sizes: 100mg/10mL and 500 mg/50mL.

Amneal to Report First Quarter 2024 Results on May 3, 2024

Retrieved on: 
Wednesday, April 10, 2024

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that the Company will release its first quarter 2024 financial results on Friday, May 3, 2024, prior to market open.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that the Company will release its first quarter 2024 financial results on Friday, May 3, 2024, prior to market open.
  • The Company will host a conference call and live webcast with the investment community at 8:30 a.m. Eastern Time.
  • Once registered, participants will receive dial-in details and unique PIN which will allow them to access the call.
  • A replay of the conference call will be posted shortly after the call and will be available for seven days.

Amneal Receives U.S. FDA Approval for Ciprofloxacin and Dexamethasone Otic Suspension

Retrieved on: 
Monday, March 25, 2024

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension.
  • “This approval represents the addition of another complex, high value medicine,” said Andy Boyer, Executive Vice President, Chief Commercial Officer - Generics.
  • “It reflects the ongoing shift of our leading affordable medicines portfolio towards complex products and the continued successful diversification of our business.”
    The most common adverse reactions reported with ciprofloxacin and dexamethasone otic suspension were ear pain (2.3%), ear discomfort (3%), and ear pruritus (1.5%).
  • For full prescribing information, see package insert located here .

Amneal Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Friday, March 1, 2024

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced its results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced its results for the fourth quarter and full year ended December 31, 2023.
  • Net revenue in the fourth quarter of 2023 was $617 million, an increase of 1% compared to $610 million in the fourth quarter of 2022.
  • Adjusted EBITDA(1) in the fourth quarter of 2023 was $142 million, a decrease of 8% compared to the fourth quarter of 2022, primarily due to investments in research and development and commercial to drive future growth.
  • Adjusted diluted EPS(1) in the fourth quarter of 2023 was $0.14, a decrease of 39% from $0.23 in the fourth quarter of 2022.

Amneal to Participate at Upcoming Investor Conference

Retrieved on: 
Tuesday, February 13, 2024

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that Chirag Patel, Co-Chief Executive Officer, will participate in the following investor conference.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that Chirag Patel, Co-Chief Executive Officer, will participate in the following investor conference.
  • A live webcast of the presentation will be accessible through the Investor Relations section of the Company's website at https://investors.amneal.com .
  • A replay of the webcast will be posted shortly after the presentation and will be available for 90 days following the event.

Deb Autor, Former FDA Deputy Commissioner, Appointed CEO of Healthcare Innovation Catalysts

Retrieved on: 
Thursday, February 1, 2024

Her government career spanned two decades, culminating in the crucial role of Deputy Commissioner of FDA where she oversaw all inspections and international operations.

Key Points: 
  • Her government career spanned two decades, culminating in the crucial role of Deputy Commissioner of FDA where she oversaw all inspections and international operations.
  • Before FDA, Ms. Autor was a decorated federal prosecutor at the U.S. Department of Justice, and FDA was her client.
  • “We are honored to have Deb take the helm as our first CEO,” stated Michael Singer, Executive Chairman of HIC.
  • Since 2018, she has served as Chair of the FDA Alumni Association, where she continues to work to support the agency’s mission.

Amneal to Report Fourth Quarter and Full Year 2023 Results on March 1, 2024

Retrieved on: 
Wednesday, January 31, 2024

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that the Company will release its fourth quarter and full year 2023 financial results on Friday, March 1, 2024, prior to market open.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) announced today that the Company will release its fourth quarter and full year 2023 financial results on Friday, March 1, 2024, prior to market open.
  • The Company will host a conference call and live webcast with the investment community at 8:30 a.m. Eastern Time.
  • Once registered, participants will receive dial-in details and unique PIN which will allow them to access the call.
  • A replay of the conference call will be posted shortly after the call and will be available for seven days.

Mallinckrodt Announces Board of Directors and Leadership Updates

Retrieved on: 
Friday, February 2, 2024

DUBLIN, Feb. 2, 2024 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today announced the appointments of Paul Bisaro, Katina Dorton, Abbas Hussain and Wesley Wheeler to its Board of Directors, effective immediately. Mr. Bisaro has also been reappointed to his previous role as Board Chair. In addition, the Company announced that Siggi Olafsson has entered into a new employment agreement and will continue in his roles as Mallinckrodt's President and Chief Executive Officer and a member of the Board.

Key Points: 
  • Four Directors Added to Board Bring Seasoned Experience in Pharmaceuticals, Healthcare, Finance and Operations
    Siggi Olafsson Will Continue as President, CEO and Board Member
    DUBLIN, Feb. 2, 2024 /PRNewswire/ -- Mallinckrodt plc ("Mallinckrodt" or the "Company"), a global specialty pharmaceutical company, today announced the appointments of Paul Bisaro, Katina Dorton, Abbas Hussain and Wesley Wheeler to its Board of Directors, effective immediately.
  • Our ability to attract these accomplished directors is a testament to what we have achieved so far and the opportunities ahead for Mallinckrodt."
  • Select professional highlights of Mallinckrodt's new directors include:
    Paul Bisaro is a healthcare industry leader with more than three decades of leadership experience at generic and branded pharmaceutical companies.
  • With the appointment of Messrs Bisaro, Hussain and Wheeler and Ms. Dorton, Mallinckrodt's Board comprises seven directors.

Amneal Launches Complex Generic Fluorometholone Ophthalmic Suspension

Retrieved on: 
Wednesday, January 10, 2024

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced the approval and launch of fluorometholone ophthalmic suspension.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced the approval and launch of fluorometholone ophthalmic suspension.
  • The product received 180-day competitive generic therapy (CGT) exclusivity from the U.S. Food and Drug Administration, a status that applies to first-marketed generics of key medicines.
  • FML® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
  • According to IQVIA®, U.S. annual sales for FML for the 12 months ended November 2023 were approximately $62 million.