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Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global leader in the pharmaceutical, medical device, and over-the-counter product industries, primarily focusing on the therapeutic areas of eye health, gastroenterology, and dermatology. The company is dedicated to advancing global health through innovation and efficient healthcare solutions.
With approximately 22,000 employees worldwide, Bausch Health operates in around 100 countries. The company's core business is organized into five segments: Salix Pharmaceuticals, International, Solta Medical, Diversified Products, and Bausch + Lomb, with the Bausch + Lomb segment generating the highest revenue. Bausch Health consistently delivers on its commitments to quality health care outcomes and customer focus.
Recent achievements include significant progress in the development of Amiselimod, a promising new treatment for ulcerative colitis, and the expansion of public drug plan listings for UCERIS® (budesonide) aerosol foam in multiple Canadian provinces. Additionally, Bausch Health has launched an awareness campaign for XIFAXAN®, an FDA-approved medication for reducing the risk of overt hepatic encephalopathy recurrence.
Financially, Bausch Health reported strong performance in the first quarter of 2024, with revenues of $2.15 billion, marking a 11% increase compared to the prior year. The company continues to strengthen its balance sheet while advancing its R&D pipeline and executing commercial strategies for global growth.
Bausch Health remains focused on protecting its intellectual property, as evidenced by recent litigation efforts to defend the XIFAXAN® franchise. The company is also committed to fostering partnerships and collaborations to enhance its product offerings and reach.
For more information, visit www.bauschhealth.com.
Bausch Health announced that it has filed a patent infringement lawsuit against Norwich Pharmaceuticals in the U.S. District Court for the District of New Jersey. This action follows a Notice of Paragraph IV Certification received on May 10, 2024, from Norwich, indicating their submission of an amendment to an Abbreviated New Drug Application (ANDA) to the FDA. This amendment seeks approval to market a generic version of XIFAXAN® (rifaximin) 550 mg tablets, used for treating diarrhea-predominant irritable bowel syndrome (IBS-D). Bausch Health has a history of defending its XIFAXAN® intellectual property, evidenced by a 2022 U.S. District Court ruling that blocked Norwich's first ANDA until October 2029. The company has since obtained additional patents related to XIFAXAN® 550 mg. Bausch Health is determined to protect its intellectual property and ensure patient safety and access to XIFAXAN®.
Bausch Health (NYSE:BHC) presented promising data from two recent clinical trials at major international healthcare conferences. At Digestive Disease Week 2024, Bausch Health shared positive results from a Phase 2 study of Amiselimod for treating mild to moderate ulcerative colitis. Both doses showed significant improvement in the Modified Mayo Score and higher rates of endoscopic improvement and clinical remission compared to placebo. Amiselimod was well-tolerated over the 12-week period.
Additionally, at the International Liver Congress 2024, Bausch Health presented pooled data analysis of Rifaximin for preventing overt hepatic encephalopathy (OHE) recurrence in cirrhosis patients. Rifaximin monotherapy significantly reduced the risk of OHE episodes and was well-tolerated compared to lactulose monotherapy.
Bausch Health, Canada announced additional public drug plan listings for PrUCERIS (budesonide) aerosol foam, expanding access for adults with mild to moderate distal ulcerative colitis. New listings include Alberta, Prince Edward Island, Newfoundland and Labrador, and federal plans for Indigenous people and Veterans. Previously, UCERIS was available in Ontario, Quebec, Saskatchewan, New Brunswick, and Nova Scotia. UCERIS, approved in Canada since September 2023, offers a unique glucocorticosteroid rectal foam for remission induction. Clinical trials showed superior efficacy over placebo in remission and rectal bleeding control at Week 6.
Bausch Health Companies (NYSE:BHC)(TSX:BHC) and its gastroenterology unit, Salix Pharmaceuticals, will present late-breaking data from a Phase 2 trial of Amiselimod for active ulcerative colitis (UC) at Digestive Disease Week 2024. The presentation, scheduled for May 19, 2024, in Washington D.C., will highlight Amiselimod's potential as an oral treatment for UC remission. The 12-week, double-blind, placebo-controlled study involved 320 patients and showed positive topline results, as announced in December 2023. The abstract, titled "Amiselimod for the treatment of active ulcerative colitis," authored by Stephen B. Hanauer et al., emphasizes Bausch's commitment to innovative UC therapies.
Bausch Health (NYSE:BHC, TSX:BHC) announced the results of its 2024 annual meeting of shareholders held on May 14, 2024. All 10 nominated directors were elected with Thomas J. Appio receiving 181,373,219 votes for and 10,918,741 votes withheld. Shareholders approved the compensation of the named executive officers, an amendment to the 2014 Omnibus Incentive Plan, and the appointment of PricewaterhouseCoopers LLP as the independent registered public accounting firm. The final vote results will be reported to the U.S. SEC on Form 8-K and will be available on SEDAR and the company's website.
Bausch Health Companies (NYSE:BHC, TSX:BHC) and Salix Pharmaceuticals updated on their litigation with Norwich Pharmaceuticals. Following the US Court of Appeals' April 11, 2024 decision, both companies filed for rehearing. They expect a decision within three months. Additionally, on May 10, 2024, Norwich filed an amendment to their ANDA with the FDA, seeking approval for a generic XIFAXAN® (rifaximin) 550 mg tablets for IBS-D treatment. Bausch has 45 days to file a patent infringement lawsuit, which would delay FDA approval of Norwich's ANDA by up to 30 months or until a court decision.
Salix Pharmaceuticals, a subsidiary of Bausch Health Companies Inc. (NYSE:BHC), announces Bellamy Young as the spokesperson for Xifaxan, the first FDA approved medication for reducing the risk of OHE recurrence in adults with cirrhosis. Overt Hepatic Encephalopathy is a serious complication of liver cirrhosis, affecting up to 80% of patients. Young aims to raise awareness and share her personal OHE experience to educate patients and caregivers about the management options available through the Xifaxan campaign.
Bausch Health announced first quarter 2024 results with revenues of $2.15 billion, up 11%, GAAP net loss of $64 million, and adjusted EBITDA of $665 million, up 13%. The Xifaxan appeal decision is a milestone related to Bausch + Lomb separation. R&D updates include positive data for Amiselimod and progress in other studies. Revenue growth in all segments, with reaffirmed full-year guidance.
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