Teva Pharm - TEVA STOCK NEWS

Teva reported a strong Q2 2024 with revenues of $4.2 billion, a 7% increase in USD and 11% in local currency compared to Q2 2023.

Generics saw growth across all regions with U.S. revenues up 16%, European up 8%, and International Markets up 22%. AUSTEDO U.S. revenues increased by 32% to $407 million, prompting a raised 2024 revenue outlook to ~$1.6 billion. AJOVY global revenues rose 12% to $115 million.

Teva accelerated development for duvakitug (Anti-TL1A) with top-line results expected in Q4 2024. Positive Phase 3 results were announced for olanzapine LAI. SIMLANDI and SELARSDI launches are planned for 2024 and 2025, respectively.

Financial highlights include a GAAP loss per share of $0.75 and a non-GAAP EPS of $0.61. The company raised its 2024 outlook, expecting revenues between $16.0 - $16.4 billion and adjusted EBITDA of $4.6 - $5.0 billion.

Net losses were $846 million, with a significant tax expense affecting results. Free cash flow decreased to $324 million from $632 million in Q2 2023, and total debt was reduced to $18.64 billion.

Teva Pharmaceuticals and Sanofi have announced an accelerated timeline for their anti-TL1A Phase 2b program in inflammatory bowel disease (IBD) patients. The RELIEVE UCCD trial, investigating duvakitug for moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD), has completed patient enrollment earlier than expected due to rapid recruitment. As a result, topline results for both UC and CD are now anticipated in Q4 2024, with detailed results to be presented in 2025. This acceleration replaces the previously planned interim analysis for the second half of 2024. Teva and Sanofi are collaborating to co-develop and co-commercialize duvakitug, potentially a best-in-class IBD treatment.

Teva Pharmaceutical Industries (NYSE and TASE: TEVA) announced positive topline results from its Phase 3 SPACE study evaluating AJOVY (fremanezumab) for the prevention of episodic migraine in children and adolescents aged 6-17 years. The trial met its primary endpoint, demonstrating statistically significant superior efficacy over placebo in reducing Monthly Migraine Days during 12 weeks of treatment. Safety data was consistent with adult populations, with no new safety signals observed.

This marks the first Phase 3 evidence of safety and efficacy for an anti-CGRP monoclonal antibody in pediatric migraine prevention. The results are particularly significant given the lack of approved preventive treatments for children and adolescents. Full data will be presented at a medical meeting later in 2024. Teva continues to study AJOVY in pediatric patients with chronic migraine.

Teva Pharmaceutical Industries will release its Q2 2024 financial results on July 31, 2024, at 7:00 a.m. ET. The company will host a conference call and live webcast to discuss the results at 8:00 a.m. ET the same day. Interested participants must register in advance to receive a local or toll-free phone number and a personal PIN. The webcast will be accessible on Teva's website and a replay will be available within 24 hours.

Teva Pharmaceutical Industries (NYSE: TEVA) has released new data from the 4th interim analysis of the PEARL study on AJOVY® (fremanezumab) for migraine prevention. The sub-analysis, presented at the 10th European Association of Neurology congress, suggests that treatment pauses may worsen patient outcomes. Data indicated over 40% of patients experienced a rapid increase in migraine days post-cessation. Effectiveness was lower upon reinitiation, with only 35.7% and 45.5% of patients achieving significant reduction in monthly migraine days at Months 1 and 3, respectively, compared to 49.0% and 58.9% before cessation. The findings challenge current reimbursement guidelines recommending treatment pauses and advocate for continuous, personalized migraine management.

Teva Pharmaceutical Industries (NYSE and TASE: TEVA) has reached an agreement with the Israel Tax Authority, resolving all ongoing litigation concerning taxes for the years 2008-2020. Teva will pay $750 million in installments from 2024 to 2029. Additionally, if Teva pays dividends or repurchases shares, it will incur an extra tax of 5%-7%, capped at approximately $500 million. This settlement allows Teva to close this historical tax issue and concentrate on its 'Pivot to Growth' strategy. The announcement does not affect Teva’s 2024 financial outlook. Teva is a global pharmaceutical leader, employing 37,000 people across 58 countries, and remains committed to contributing to Israel's economy.

Teva Pharmaceuticals has launched the first-ever authorized generic version of Victoza® (liraglutide injection 1.8mg) in the United States. The generic version, aimed at improving glycemic control and reducing cardiovascular risks in type 2 diabetes patients, expands Teva's complex generics portfolio. Victoza® had annual sales of $1.656 billion as of April 2024. The launch signifies Teva's ongoing commitment to providing affordable medication options.

Teva Pharmaceutical Industries announced that its President and CEO, Richard Francis, will present at the Goldman Sachs 45th Annual Global Healthcare Conference on June 11, 2024. The presentation is scheduled to begin at 8:00 A.M. Eastern Time. A live webcast of the presentation will be available on Teva's Investor Relations website, with an archived version accessible within 24 hours post-event.

Teva Pharmaceuticals presented new data at the Psych Congress Elevate 2024 regarding UZEDY® (risperidone), an extended-release injectable suspension for treating schizophrenia. Key findings include that switching to UZEDY at four weeks after the last dose of once-monthly paliperidone palmitate provides a comparable pharmacokinetic (PK) profile. Additional Phase 3 RISE and SHINE studies showed no new safety concerns in young adults. The Global ADVANCE survey revealed real-world insights from healthcare professionals, caregivers, and patients on long-acting injectable (LAI) treatments. UZEDY can be administered subcutaneously without a loading dose, offering convenience and relapse prevention.