Fortress Biotech (FBIO) Q3 2024 earnings summary

Executive summary

• Net revenue for Q3 2024 was $14.6M, down 58% year-over-year due to a one-time $19M payment in Q3 2023; nine-month revenue was $42.6M, down 34% year-over-year.

• FDA approved Emrosi for rosacea in November 2024, marking the first FDA approval in Fortress' portfolio.

• Fortress advances late-stage assets, including cosibelimab (BLA under FDA review, PDUFA date December 28, 2024) and maintains a late-stage pipeline with multiple regulatory milestones.

• Revenue is primarily from Journey Medical's dermatology products, with Qbrexza growing but legacy products declining.

• Fortress and subsidiaries are pursuing clinical programs, asset sales, and collaborations to optimize the portfolio.

Financial highlights

• Q3 2024 net loss attributable to Fortress was $12.9M–$15.0M, or $(0.76) per share, compared to $5.0M–$7.1M, or $(0.94) per share, in Q3 2023.

• Cash and cash equivalents at September 30, 2024, were $58.9M, down from $76.2M at June 30, 2024.

• Operating expenses for Q3 2024 were $36.7M, down 24% year-over-year, with R&D at $9.4M (down 53%) and SG&A at $22.0M (up 1%).

• Q3 2024 included a $3.6M loss on extinguishment of debt related to refinancing with Oaktree.

• Weighted average common shares outstanding increased to 19.7M in Q3 2024 from 7.5M in Q3 2023.

Outlook and guidance

• Fortress expects R&D and SG&A expenses to remain flat or slightly lower in 2024 due to portfolio optimization and cost reduction.

• Emrosi is expected to launch late Q1 or early Q2 2025; up to two additional FDA approvals possible in the next nine months.

• Cash runway is projected to last at least 12 months; additional capital may be sought for future development and commercialization.