Formycon (FYB) Investor Update summary

Key program updates

• FYB201 (Lucentis biosimilar) may see a temporary pause in U.S. commercialization to enable strategic repositioning, with no impact on ex-U.S. markets.

• FYB202 (Stelara biosimilar) faces a more competitive U.S. pricing environment, prompting a downward adjustment in revenue expectations and a non-cash extraordinary impairment for 2024.

• FYB206 (Keytruda biosimilar) received an FDA waiver for the Phase III lung cancer trial, streamlining development and reducing costs, with ongoing melanoma trial progressing as planned.

Financial outlook and guidance

• Non-cash impairments for FYB201 and FYB202 will negatively impact net results, but key KPIs like revenue and EBITDA remain unaffected.

• FYB202 retains about three-quarters of its previously modeled value after adjustment; FYB201's impact is much smaller.

• Significant cost savings from FYB206's streamlined development will partially offset impairments and provide funding headroom for pipeline projects.

• Medium-term profitability and positive cash flow targets remain, though break-even may shift slightly later, likely to 2026–2027.

• Cash runway is expected to extend into Q2 2026, with no immediate need for renegotiation of commercial terms.

Regulatory and market environment

• FDA's Phase III waiver for FYB206 signals a broader regulatory shift toward streamlined biosimilar development, with EMA expected to follow suit.

• U.S. biosimilar market dynamics remain complex, with the buy-and-build segment more mature than the pharmacy benefit channel, which still faces structural barriers.

• Partnerships with Sandoz and Fresenius Kabi remain strong, with no current plans to renegotiate commercial agreements.

• Milestone and earnout structures are largely unchanged, with reductions in earnout obligations reflecting lower revenue expectations.