Teva Pharmaceutical Industries Limited American Depositary Shares - TEVA STOCK NEWS

Teva Pharmaceutical Industries reported Q1 2022 revenues of $3.7 billion, a decrease of 8% year-over-year, primarily due to lower sales in North America. GAAP diluted loss per share was $0.86, while non-GAAP diluted EPS was $0.55. The revenue outlook for 2022 has been revised lower to $15.4 - $16.0 billion amidst foreign exchange challenges and increased competition for COPAXONE, now expected at ~$750 million. Despite these challenges, Teva reaffirmed its adjusted EBITDA guidance of $4.7 - $5.0 billion and free cash flow of $1.9 - $2.2 billion.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Auspex Pharmaceuticals have settled litigation with Lupin concerning Lupin’s ANDA for a generic version of Teva's AUSTEDO (deutetrabenazine). Under the agreement, Lupin is granted a license to sell the generic product beginning in April 2033. AUSTEDO is the only FDA-approved treatment for tardive dyskinesia and chorea associated with Huntington’s disease. Teva's intellectual property related to AUSTEDO remains intact as they continue to litigate against Aurobindo over its ANDA for a similar product.

Teva Pharmaceuticals and MedinCell announced the U.S. FDA has issued a Complete Response Letter for their New Drug Application for TV-46000 (risperidone extended-release injectable). This application aimed to treat schizophrenia but has been halted pending further review. Teva plans to collaborate with the FDA to address the feedback and continue product development. The application was based on two pivotal studies demonstrating the drug's safety and efficacy in managing schizophrenia symptoms.

Teva Pharmaceuticals, in collaboration with MedinCell, received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application for TV-46000/mdc-IRM, an injectable treatment for schizophrenia. This letter indicates that the application cannot be approved in its current form. Teva aims to work with the FDA to address feedback and remains dedicated to developing this treatment. The application was based on Phase 3 data from two pivotal studies assessing the drug's efficacy and safety.

On April 5, 2022, National Caregiver Day in Canada, Teva Canada announced a partnership with People Before Patients to enhance healthcare delivery. They launched a series of five podcasts featuring healthcare leaders and initiated a national online survey to gather insights on improving Canadian healthcare. A live virtual event is scheduled for May 10, 2022, with keynote speaker Michael Landsberg. Teva Canada has also expanded its Caregiver-Friendly Pharmacy program, aimed at supporting the 8.1 million caregivers in Canada, amidst challenges from the pandemic.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) will release its first quarter 2022 financial results on May 3, 2022, at 7:00 a.m. ET. A conference call and live webcast will follow at 8:00 a.m. ET. Participants can join by dialing the following numbers: 1-877-870-9135 (US), 1-809-213-985 (Israel), or +44 (0) 2071 928338 (International) using passcode 8636304. A replay will be available shortly after the call. Teva is a global leader in generic and specialty medicines, offering over 3,500 products worldwide.

Teva Pharmaceuticals announced new data on AJOVY and AUSTEDO, showcasing their safety and efficacy at the American Academy of Neurology Annual Meeting from April 2-7, 2022. The research highlights include 11 abstracts on AJOVY for migraine treatment, focusing on its effectiveness across various patient demographics. Furthermore, AUSTEDO's long-term analyses for tardive dyskinesia were presented, revealing insights on treatment outcomes. Teva aims to enhance understanding of these therapies while supporting the healthcare community's knowledge.

Teva Pharmaceuticals has reached a settlement with Florida's Attorney General, resolving opioid-related claims. The agreement includes payments totaling $177 million over 15 years and provides generic Narcan (naloxone hydrochloride) valued at $84 million over 10 years. This resolution aims to assist those suffering from opioid addiction and does not imply any admission of liability by Teva. The company will maintain its defense in ongoing litigations in states without settlements.

Teva Pharmaceuticals has reached a settlement with Rhode Island's Attorney General concerning opioid-related claims, agreeing to pay $21 million over 13 years. Additionally, Teva will provide generic Narcan and Suboxone, valued at $78.5 million, over 10 years. This settlement is seen as a step towards addressing the opioid crisis and does not imply any admission of wrongdoing. Teva continues to pursue a national settlement, while stating that the agreement will help distribute life-saving treatments effectively in Rhode Island.