27 slides from Teva Pharmaceutical Industries's technical presentation, Sep 22, 2025
Slide 1: Olanzapine LAI (TEV-'749) Phase 3 SOLARIS Data Conference Call
teva Olanzapine LAI (TEV-'749) Phase 3 SOLARIS Data Presentation — Conference Call September 22, 2025 scene a
Slide 2: Forward-looking statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our futu
Slide 3: Presenters
Presenters 1 Teva in Neuroscience EVP, Global R&D & Chief Medical Officer 2 Significant unmet need in Schizophrenia Executive Vice President, U.S. Commercial 3 Solaris (TEV-‘749) data update Professor of Psychiatry Zucker School of Medicine, Hempstead, NY SOLARIS study coordinating investigator 4 Co
Slide 4: Executive Vice President, Global R&D & Chief Medical Officer
Executive Vice President, Global R&D & Chief Medical Officer 4|
Slide 5: Legacy, In-line, and Pipeline Assets
Under Regulatory Legacy Marketed Phase 3 Phase 2 Review olanzapine LAI Emrusolmin UZEDY ® (TEV-'749) (TEV-'286) Bipolar Schizophrenia MSA Legacy, In-line, and Pipeline Assets In house R&D experts with proven Substantial, experienced commercial track record developing neuroscience neuroscience teams
Slide 6: Functional Deficits in Schizophrenia
Decline in or loss of normal Distortion of thinking and perception1 functions1 • Delusions1,2 • Alogia1,2 Positive • Hallucinations1,2 • Abulia1/Amotivation2 Negative Symptoms • Delusional thinking2 • Avolition1,2 Symptoms • Bizarre thoughts2 Functional • Anhedonia1,2 • Paranoia2 Deficits • Asociali
Slide 7: Long untreated psychosis associated with poor long-term outcomes
Long untreated psychosis associated with poor long-term outcomes Premorbid Prodromal phase Progressive phase Chronic phase phase Functional impairment Acute exacerbations Remission Negative Psychosocial outcomes become symptoms poorer with an increasing number Disability of relapses1 Cognitive defic
Slide 8: SteadyTeq technology
SteadyTeq® technology 8| SC: Subcutaneous Mode of Action – TEV ’749 (olanzapine LAI) on Vimeo Note: SteadyTeq® is Teva's trademark for the BEPO technology it licenses from Medincell.
Slide 9: Olanzapine LAI release profile and safety
In vitro release tested in human plasma 120 100 ~4,000 SC injections across of Olanzapine plasma ± SD multiple clinical studies, with no Rapid uncontrolled release PDSS observed 80 from Zyprexa Relprevv®, which OlZ in human can cause PDSS Teva’s olanzapine LAI met primary 60 and key secondary effica
Slide 10: Executive Vice President, U.S. Commercial
Executive Vice President, U.S. Commercial 10 |
Slide 11: Building a best-in-class LAI franchise
Building a best-in-class LAI franchise Estimated ~4.7M1 Olanzapine LAI prevalent schizophrenia TEV-’749 patients in the US and Europe Aim to be the preferred LAI for: Anticipated for: Patients appropriate for oral Patients appropriate for oral risperidone or paliperidone olanzapine Modestly controll
Slide 12: Large patient population with unmet needs
Large patient population with unmet needs schizophrenia market, of which for LAI1 Number of patients in millions (2024) ~2.3M ~2.4M Schizophrenia prevalence 2.1M 2.3M Diagnosed patients 1.7M 1.8M Treated patients ~20% ~30% oral olanzapine 13% 16% % of patients treated with LAI <1% ~1% olanzapine LAI
Slide 13: Requirements for success in schizophrenia market
Requirements sor success in schizophrenia market Complex patient journey creating multiple relapses Requirements to increase LAI penetration Often misdiagnosed as stress LAI potentially Deep understanding of or depression for several years prescribed the patient journey Demonstrated safety profile P
Slide 14: Summarizing the commercial opportunity
Summarizing the commercial opportunity Answering a true unmet need with a differentiated LAI franchise Addressing a broad spectrum of patients with UZEDY and olanzapine LAI: 65%-80% of patients with potential to switch as currently on similar molecule1 Leveraging best-in-class go-to-market capabilit
Slide 15: Professor of Psychiatry, SOLARIS Study Coordinating Investigator
Professor of Psychiatry Zucker School of Medicine, Hempstead, NY SOLARIS Study Coordinating Investigator 15 |
Slide 16: SOLARIS Phase 3 study design
Phase 3 randomized, double-blind, placebo-controlled (Period 1), open- label long-term safety (Period 2) trial to evaluate efficacy, safety in adult patients with acute exacerbation of schizophrenia Period 1 (8 weeks, n=675) aimed to assess the efficacy and safety, of TEV- Treatment period ’749 schi
Slide 17: Change in PANSS total score
LS mean change from baseline to Week 8 in PANSS Mean PANSS total score from Period 2 baselinea by total score1 visit and treatment group (full analysis set)2 • Mean change from baseline to end of treatment at any time for all TEV-’749 groups was -7.2 (SD: 16.21) • In addition to PANSS total scores,
Slide 18: Most common adverse events in SOLARIS
318 mg 425 mg 531 mg Total Most Common Adverse Events in SOLARIS Integrated Trial Period (n=204) (n=203) (n=197) (N=604) Participants with treatment-emergent AEs, n (%) Weight increased 73 (36) 78 (38) 69 (35) 220 (36) Injection-site induration 20 (10) 27 (13) 28 (14) 75 (12) Injection-site pain 25
Slide 19: Potential to be first LAI olanzapine to avoid PDSS risk
All TEV-’749 doses Long-term safety profile No suspected or TEV-’749 Long-term exhibited long-term, of TEV-’749 is consistent confirmed PDSS events change in weight and continuous symptom with other olanzapine reported in 3470 metabolic parameters improvement and formulations. injections. comparable
Slide 20: Executive Vice President, Global R&D & Chief Medical Officer
Executive Vice President, Global R&D & Chief Medical Officer 20 |
Slide 21: SOLARIS data featured in two special sessions at Psych 2025
SOLARIS Trial Data Were Selected to Be Featured in Two Special Sessions at Psych 2025 Invited Oral Session Poster Award Nomination Poster Title: Long-Term Effectiveness With Subcutaneous Poster title: Long-Term Safety of Subcutaneous Long-Acting Injectable Olanzapine (TEV-’749) Long-Acting Injectabl
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Slide 23: Additional Information
teva Additional a, Information , ©
Slide 24: PANSS improvement with TEV-'749 versus placebo
Greater clinical improvement at week 8 in PANSS total score with TEV-’749 versus placebo, with safety profile consistent with other approved olanzapine formulations.1,2 Primary and key secondary No new systemic Acceptable Low discontinuation endpoints met at week 8 safety signals ISR rates due to AE
Slide 25: Weight change from baseline
Weight change from baseline to Weight change in long-term Weight change from baseline to end of Period 1 ≥ 48 weeks studies for olanzapine Hospitalization was mandatory for ≥ 4 weeksa Open-label period monotherapy in adultsb,6,7 16 14 Weight change from Placebo baseline (kg) + SD 12 10 Total TV-4474
Slide 26: Participants with ISRs by injection number
Participants with ISRs, by injection number (safety analysis set) 30 Participants with ISRs, n (%) 25 146 (24) 20 69 (14) 15 10 22 (6) 16 (5) 10 (4) 8 (4) 5 4 (3) 4 (3) 4 (2) 3 (2) 3 (2) 2 (2) 2 (2) 2 (<1) 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 (N=604) (n=492) (n=378) (n=303) (n=255) (n=226) (n=205) (n=
Slide 27: Thank You
teva Thank You