MedinCell (MEDCL) H2 23/24 earnings summary

Executive summary

• UZEDY launched in the US in May 2023, with strong prescription growth and a 2024 sales outlook of $80 million, generating €3.6 million in milestones and €1.7 million in royalties.

• Strategic partnership with AbbVie signed in April 2024, bringing $35 million (€35 million) upfront and up to $1.9 billion in milestones for up to six products.

• Positive Phase 3 results for olanzapine LAI (mdc-TJK), with no PDSS reported and recruitment completed nine months early.

• Encouraging Phase 3 data for intraarticular celecoxib (mdc-CWM), with improvements in secondary endpoints and no new safety signals.

• Advanced R&D pipeline and new American investor support, with initiatives to accelerate internal development timelines.

Financial highlights

• Revenues and other income: €11.9 million, down 13% year-over-year, with €3.6 million in Teva milestones and €1.7 million in UZEDY royalties.

• Net result: €(25.0) million, a 22% improvement year-over-year; operating result: €(21.0) million.

• Operating expenses: €32.9 million, with R&D representing 64% of costs.

• Cash position: €19.5 million as of March 31, 2024, up from €6.5 million, bolstered by capital increases and loan tranches.

• Cash consumption from operating activities: €11.9 million, a 43% decrease year-over-year.

Outlook and guidance

• UZEDY 2024 revenue guidance reaffirmed at $80 million, with anticipated royalty ramp-up and market access improvements.

• Olanzapine LAI and mdc-TJK expected to drive future revenue, with possible marketing authorization by end of 2025.

• AbbVie partnership expected to generate significant milestone and royalty income, up to $350 million per program.

• Operating breakeven targeted by 2026-2027, supported by high-margin revenue streams.