Biofrontera Inc. (BFRI)·Q4 2024 Earnings Summary

Executive Summary

• Q4 2024 was a mixed print: revenue grew 18.5% y/y to $12.6M but missed consensus; EPS remained negative as non-recurring gains that boosted the prior-year comp did not recur, though gross margin improved with lower transfer pricing and a Q4 price increase .
• Against S&P Global consensus, BFRI missed on both revenue ($12.56M vs $14.53M*) and EPS (-$0.23* vs -$0.07*) for Q4; FY24 also came in below on revenue ($37.32M vs $39.31M*) and EPS (-$3.46* vs -$2.98*) (Values retrieved from S&P Global).*
• Execution positives: 52 RhodoLED XL placements in Q4 (100 since June launch), FDA approval to use up to three tubes of Ameluz per treatment, and strong Phase 3 sBCC topline; management reiterated a push toward cash flow positive in 2025 .
• 2025 set-up: gross margin tailwind from transfer price cut to 25% through 2025, SG&A and R&D expected to hold approximately steady, and further label-expansion milestones (AK trunk/extremities PK underway; sBCC filing targeted H2 2025) .

What Went Well and What Went Wrong

• What Went Well

  • Device adoption accelerated: 52 RhodoLED XL units placed in Q4; 100 installed since the June 2024 launch, expanding capacity for larger-field PDT .
  • Label/pricing catalysts: FDA approved up to three Ameluz tubes per treatment; Ameluz price increased 5% in Q4, supporting ASP and mix .
  • Pipeline momentum: Phase 3 sBCC topline showed highly significant efficacy across endpoints; company targets FDA submission in H2 2025; management emphasized advancing label expansion and driving toward cash flow positive operations .

• What Went Wrong

  • Estimates miss: Q4 revenue of $12.56M vs $14.53M* estimated and EPS -$0.23* vs -$0.07*; FY24 also under consensus on revenue and EPS (Values retrieved from S&P Global).*
  • Profitability still negative: Q4 net loss of $1.4M (vs prior-year net income from a legal settlement), with adjusted EBITDA at -$1.4M despite revenue growth .
  • Prior-quarter disruptions underscore fragility: Q3 shipments were delayed by Hurricane Milton (pushed into Q4), highlighting sensitivity to logistics and customer operations .

Financial Results

Quarterly trends

Year-over-year comparison

Estimates vs actuals (S&P Global consensus)

Values retrieved from S&P Global.*

KPIs and operating metrics

Notes: Gross profit/margins are calculated from reported revenue and cost of revenues. Prior-year Q4 EPS benefitted from a legal settlement gain in 2023 .

Guidance Changes

No formal quantitative revenue, margin, tax, or opex dollar guidance was provided in Q4 materials .

Earnings Call Themes & Trends

Management Commentary

• “I am pleased with $37.3 million in sales in 2024… and is a record for our company… We strongly believe… [this] will allow us to achieve another record year in 2025.”
• “We placed 52 RhodoLED XL lamps in the fourth quarter… and 100 between the launch in June 2024 and the end of 2024.”
• “We obtained FDA approval to use up to 3 tubes of Ameluz per treatment.”
• “We… negotiated… transfer price of Ameluz… reduced from 50% to 25% for all purchases in ‘24 and ‘25.”
• “We are putting a great deal of emphasis on becoming cash flow positive and managing our expenses without sacrificing sales.”

Q&A Highlights

• Margin outlook: Management emphasized the full-year 2025 benefit of the 25% transfer price (vs 50% historically) after seeing initial COGS mix benefit in Q4 .
• Pricing: Ameluz price increase in Q4 was 5%; some customers forward-bought in Q3 ahead of the hike .
• Opex: SG&A and R&D to hold approximately steady in 2025 as cost structure has been calibrated to current scale .
• Pipeline cadence: Acne Phase II enrollment stood at 116; management may conclude the trial slightly earlier than planned based on current data trajectory .

Estimates Context

• Q4 2024: Revenue $12.56M* vs $14.53M* consensus; Primary EPS -$0.23* vs -$0.07* consensus → both below expectations (Values retrieved from S&P Global).*
• FY 2024: Revenue $37.32M* vs $39.31M* consensus; Primary EPS -$3.46* vs -$2.98* consensus → below on both revenue and EPS (Values retrieved from S&P Global).*
• Implication: Despite improving gross margin drivers (transfer price cut, pricing, device mix), operating scale and lack of non-recurring gains weighed on EPS; estimate models may need to reflect higher gross margin trajectory in 2025, steady SG&A/R&D, and device-driven adoption, but also conservative uptake/reimbursement timelines for label expansions .

Key Takeaways for Investors

• Revenue growth improving on device adoption and pricing, but near-term EPS still pressured absent non-recurring gains; 2025 margin tailwinds are tangible via 25% transfer pricing .
• Q4 miss vs consensus sets a lower bar; watch for sequential momentum as XL penetration and three-tube label drive larger-field treatments and physician throughput .
• Pipeline catalysts: sBCC U.S. filing targeted H2 2025; AK trunk/extremities advancement (PK study underway) could broaden addressable market and throughput .
• Opex discipline to persist (SG&A/R&D stable), supporting path toward cash flow positive; cash of $5.9M at year-end and November $4.2M convertible note bolster liquidity runway .
• Near-term trading setup: sentiment likely hinges on evidence of sustained gross margin expansion and device/three-tube-driven utilization; any update on payor reimbursement for label changes could be a catalyst .
• Medium-term thesis: if label expansions (sBCC, AK body) and device footprint translate to higher treatment volumes per visit, revenue scale and margin mix can inflect, narrowing losses; execution on reimbursement and clinical timelines remains key .