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Teva Pharmaceutical Industries Limited (NASDAQ: TEVA) is a leading Israeli multinational pharmaceutical company headquartered in Tel Aviv, Israel. As the world's largest generic drug manufacturer, Teva plays a pivotal role in the global healthcare industry. The company derives approximately 50% of its sales from North America, contributing significantly to the total number of generic prescriptions in the United States.
Teva's extensive portfolio includes not only generic drugs but also active pharmaceutical ingredients (APIs) and proprietary pharmaceuticals. The company's operations are categorized into three main therapeutic areas:
- Central Nervous System (CNS): Featuring notable products such as Copaxone, Ajovy, and Austedo, Teva addresses critical CNS disorders with innovative treatments.
- Respiratory: Products like Qvar and ProAir contribute to Teva's robust respiratory medicine lineup, catering to patients with various respiratory conditions.
- Oncology: Teva's oncology portfolio includes groundbreaking medicines such as Truxima, Herzuma, and Bendeka/Treanda, providing essential treatments for cancer patients.
In addition to its pharmaceutical products, Teva is a major player in active pharmaceutical ingredients, offering contract manufacturing services and owning Anda, a U.S.-based distributor of generic and specialty drugs.
Teva's global presence extends beyond North America, with significant operations in Europe, Japan, Russia, and its home country, Israel. The company's strategic partnerships and innovations keep it at the forefront of the pharmaceutical industry. Recent developments include advancements in biosimilars and innovative treatments.
Financially, Teva continues to maintain a strong position, focusing on growth and resilience amidst market challenges. The company is committed to improving patient health worldwide by providing high-quality, affordable medicines.
Teva Pharmaceuticals announced findings from a clinical study on SABA use among asthma patients, presented at the ATS 2022 Annual Meeting. The study revealed significant SABA overuse, with nearly one-third of patients making over 138 inhalations in 12 weeks. Key findings indicated that 89% of patients exceeded the consensus threshold for SABA use, suggesting a potential risk for asthma exacerbation. The ProAir Digihaler digital inhaler was highlighted as a tool to help healthcare providers make informed treatment decisions based on real-time patient data.
Teva Canada Limited has announced the public formulary coverage for AJOVY® (fremanezumab) in several provinces including Ontario, British Columbia, Nova Scotia, New Brunswick, and Newfoundland, enhancing accessibility for migraine patients across Canada. AJOVY® is indicated for adults with at least four migraine days monthly. This development follows similar coverage announcements in Alberta, Saskatchewan, and Québec. The increased availability of AJOVY® is expected to improve the quality of life for many Canadians suffering from migraines.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) will present findings at the ATS 2022 Annual Meeting held from May 13-18, 2022, in San Francisco. These findings focus on the use of short-acting beta agonists (SABA) in asthma patients, utilizing data from the ProAir Digihaler. This analysis applies clinical usage thresholds from independent experts to objective patient data, marking the first such study of its kind. The research highlights the potential for digital inhalers to enhance asthma management and patient outcomes.
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.
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