MedinCell (MEDCL) investor relations material

FDA approval and product profile

• FDA approved WELTRUZA as the first and only once-monthly subcutaneous olanzapine LAI for adults with schizophrenia, and the second FDA-approved medicine using the technology after UZEDY.

• No loading dose, oral supplementation at initiation or post-injection monitoring; three doses correspond to commonly prescribed oral doses.

• SOLARIS showed efficacy across symptoms, illness severity and functioning; systemic safety was consistent with oral olanzapine, with no PDSS cases in clinical development.

• Around 300,000 U.S. patients use oral olanzapine; schizophrenia LAI penetration is expected to rise from ~13% in 2025 to 18% beyond 2030.

• Teva plans U.S. availability in the coming weeks, with launch planned for Q4 2026; uptake will depend on reimbursement, physician adoption and access.

Commercial and financial framework

• WELTRUZA and UZEDY each carry mid- to high-single-digit royalties on worldwide net sales; remaining milestone eligibility is up to $112M for WELTRUZA and $108M for UZEDY.

• WELTRUZA’s $4M U.S. approval milestone is payable in the coming weeks; up to $105M is sales-based, and a further $3M is due upon approvals in different EU countries, expected late 2027 or early 2028.

• Teva’s public combined peak-sales estimate for WELTRUZA and UZEDY is up to $2B, not MedinCell guidance; annual royalties could approach $150M at that level, depending on sales and rates.

• UZEDY is expected to approach $300M in sales this year and target blockbuster status by the early 2030s; Teva’s $2B estimate was described as somewhat conservative but remains public guidance.

• WELTRUZA’s U.S. patent portfolio includes granted patents extending to 2044, subject to potential challenges and not guaranteed exclusivity through that date.

Portfolio and pipeline priorities

• UZEDY and WELTRUZA address different needs and cover the two most widely prescribed atypical antipsychotics, with potential to reach roughly 75% of U.S. schizophrenia patients.

• BEPO Star is being applied across new collaborations and internal programs; its technology patent life extends to 2040 versus 2033 for BEPO linear.

• Further data increased interest in the third-generation platform; scale-up is accelerating and use in selected partnerships is under consideration.

• The first AbbVie program is part of the pipeline; accelerating pipeline growth and allocating resources remain priorities.

• Early information suggests GLP-1s may mitigate olanzapine-related weight gain; the potential is being evaluated, with semaglutide expected to lose patent protection in 2031.