Formycon (FYB) Investor Update summary

Strategic updates on biosimilar programs

• U.S. commercialization strategy for FYB201 (Cimerli) may involve a temporary pause to optimize long-term competitiveness, 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.

• Partnerships with Sandoz and Fresenius Kabi remain strong, and launch preparations for FYB202 in the U.S. and Europe are ongoing.

• Regulatory trends suggest broader adoption of streamlined clinical development for biosimilars, with EMA expected to publish a new strategy soon.

Financial implications and outlook

• Non-cash impairments for FYB201 and FYB202 will negatively impact net results for 2024, but key KPIs like revenues and EBITDA remain unaffected.

• FYB202 impairment is expected in the high double-digit to low triple-digit million range; FYB201 in the low double-digit range.

• Significant cost savings from the FYB206 Phase III waiver will partially offset impairments and provide headroom for pipeline development.

• Medium- and long-term plans anticipate sustainable revenue growth and positive EBITDA, with profitability targeted in the midterm.

• Cash runway is expected to last into Q2 2026, with no immediate changes to financial stability.

Market and regulatory environment

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

• Political and regulatory efforts are ongoing to improve PBM transparency and biosimilar adoption in the U.S.

• High demand for biosimilars continues globally, with the company positioned as a leading development partner.

• No current plans to renegotiate commercial terms with Sandoz or Fresenius Kabi; milestone structures remain unchanged.

• Earnout obligations for FYB201 are significantly higher than for FYB202, with adjustments reflecting revised commercial expectations.