MedinCell (MEDCL) H2 23/24 earnings summary

Executive summary

• UZEDY launched in May 2023 with strong US prescription growth, $80 million 2024 sales guidance, and first royalties recognized; FDA approval and €3.6M milestone, €1.7M royalties received.

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

• Positive Phase 3 results for olanzapine LAI (mdc-TJK), with no PDSS in nearly 3,000 injections and recruitment completed nine months early.

• Encouraging Phase 3 data for intraarticular celecoxib in postoperative pain management, with improvements in secondary endpoints.

• Advanced R&D pipeline and US investor strategy, with growing American fund investment and focus on accelerating development timelines.

Financial highlights

• Revenues and other income: €11.9 million, down 13% year-over-year; operating expenses: just under €33 million, with R&D at 64% of costs.

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

• Cash position: €19.5 million at March 31, 2024, up from €6.5 million the previous year, supported by capital increase and upfront payments.

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

• Additional $35 million from AbbVie received post-closing in May 2024.

Outlook and guidance

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

• Olanzapine LAI NDA filing expected in early 2025, with potential FDA approval in the second half of 2025 and impact on accounts from 2026.

• AbbVie partnership could yield up to $350 million per program in milestones for up to six products, plus royalties.

• Operating breakeven targeted by 2026-2027, supported by high-margin revenues and new partnerships.

• Cash flow visibility extended to the second half of 2027, with ongoing efforts to secure new deals and extend the cash horizon.