Strong Revenue Growth
Revenue for the 3 months ended Sept 30, 2025 was $31.1M, a 26% increase versus $24.7M in the comparable prior period. The increase was driven primarily by a $4.8M rise in HA manufacturing revenues and $1.6M increase in CDMO revenues (higher sales volumes of $2.6M partially offset by lower development revenue).
Adjusted EBITDA Turnaround
Adjusted EBITDA improved to $3.1M in Q3 2025 from negative $1.8M in the comparable prior period, a $4.9M improvement, reflecting higher gross profit and reduced SG&A.
Gross Profit Improvement
Gross profit increased to $7.8M from $5.4M, a $2.4M improvement driven by a $4.3M increase in HA manufacturing gross profit due to higher volume and manufacturing absorption.
Material SG&A Reductions
Selling, general & administrative expenses decreased to $8.9M from $14.8M, a reduction of $5.9M (~40%), including $2.2M lower recurring accounting/legal/consulting costs and $3.7M fewer nonrecurring legacy expenses.
Quality and Regulatory Validation
Successful FDA inspection earlier in the year and five positive customer audits during the quarter (including a due diligence audit by a large multinational) reinforced the company's quality systems and customer confidence.
Business Development and New Wins
Signed two new customers in Q3 and two additional customers subsequent to quarter-end (including a late-stage GLP-1 program). One post-quarter win is a commercial site transfer from a large multinational that could become a top customer when commercialized.
Late-Stage Pipeline and Commercialization Progress
Company has 11 late-stage programs with potential launches 2026–2029. Operational milestones included installation/qualification of automated manufacturing equipment, completion of two Phase III clinical batches, and plans to produce validation batches in early 2026 for a large pharma customer.
Operational Productivity Gains
Manufacturing workforce reduced by more than 20% over 18 months while producing similar volumes, signaling productivity improvements. ERP implementation planned for Q1 2026 and a Head of Business Transformation hired to drive further efficiency and procurement savings.
Reaffirmed Transition-Period Guidance
For the ~7-month transition period (May 26–Dec 31, 2025) management reaffirmed guidance: revenue ~$74–76M, adjusted EBITDA $12–14M, and net loss $18.4M–$16.4M.