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AEON Biopharma, Inc. (AEON)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 delivered positive net income of $2,083 thousand and diluted EPS of $3.75, driven primarily by non-cash fair value gains, despite no product revenue reported .
  • The company initiated primary comparative analytical studies in Q4 2024 and is pursuing the 351(k) biosimilar pathway for ABP-450 with BOTOX as the reference product; a Biosimilar BPD Type 2a meeting with FDA is planned for H2 2025 .
  • Liquidity improved post-quarter via a $20.0 million underwritten offering in January 2025; management expects funding to support its operating plan and working capital through 2025 .
  • A 1-for-72 reverse stock split was effected in February 2025 to support NYSE American compliance, and historical EPS/share data for successor periods have been retroactively adjusted in reported figures .
  • AEON disclosed NYSE American non-compliance in February 2025 related to stockholders’ equity thresholds and is submitting a plan to regain compliance by August 3, 2026, a governance overhang to monitor .

What Went Well and What Went Wrong

What Went Well

  • Initiated primary analytical studies in Q4 2024, a key milestone for the 351(k) biosimilar pathway: “As part of this program, we initiated the primary analytical studies in the fourth quarter of 2024.” — Marc Forth, CEO .
  • Regulatory alignment progressed: having held an FDA biosimilar advisory meeting in Q3, AEON believes it is aligned on initial key requirements for the 351(k) pathway .
  • Post-quarter capital raise of $20.0 million strengthens liquidity; management expects funding to cover the operating plan and working capital through 2025, with ~89% of Series B warrants exercised by March 21, 2025 .

What Went Wrong

  • No revenue reported; results remain driven by non-cash fair value changes rather than operating traction, limiting fundamental visibility for commercial metrics .
  • NYSE American non-compliance notice (Feb 2025) tied to stockholders’ equity and recent losses, requiring a remediation plan and creating listing risk .
  • Strategic execution bandwidth constrained by capital in late 2024; Q3 commentary highlighted capital resources as the “single biggest limitation,” tempering the pace of development until financing was secured .

Financial Results

Sequential quarterly results (oldest → newest):

MetricQ2 2024Q3 2024Q4 2024
Net Income ($USD Thousands)$164,112 $(6,171) $2,083
Diluted EPS ($)$4.22 $(0.16) $3.75
Operating Income ($USD Thousands)$153,473 $75,306 $(2,321)
Total Operating Expenses ($USD Thousands)$(153,473) $4,016 $2,321
Cash and Equivalents ($USD Thousands)$3,442 $537 $13

Year-over-year snapshot:

MetricQ4 2023Q4 2024
Net Income ($USD Thousands)$(26,241) $2,083
Diluted EPS ($)$(50.81) $3.75
Operating Income ($USD Thousands)$(34,726) $(2,321)
Total Operating Expenses ($USD Thousands)$34,726 $2,321
Cash and Equivalents ($USD Thousands)$5,158 $13

Balance sheet and financing KPIs:

KPI ($USD Thousands unless noted)Q2 2024Q3 2024Q4 2024
Convertible Notes at Fair Value$13,292 $15,170 $11,689
Warrant Liability$1,467 $1,844 $1,187
Contingent Consideration Liability$6,886 $6,886 $3,541
Weighted Avg Diluted Shares (units)38,843,627 41,318,831 555,344

Context and drivers:

  • Q2 and Q4 positive net income were predominantly driven by fair value changes (contingent consideration, warrants, convertible notes), not by operating revenue; Q3 reverted to a GAAP net loss as these non-cash gains normalized .
  • Cash declined into Q4 year-end, necessitating the January financing to support the 2025 operating plan .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Operating Plan FundingFY 2025n/a“Fund its operating plan and working capital through 2025” New
FDA BPD Meeting2025“Plan to hold BPD Type 2 meeting in 2025” “BPD Type 2a meeting with FDA in H2 2025” Clarified timeline (Maintained)
Comparative Analytical Studies (CAA)Q4 2024“Expected to commence in Q4 2024, subject to capital” “Initiated primary analytical studies in Q4 2024” Achieved milestone
Phase 3 CD Study (non-inferiority vs BOTOX)2024/2025“Expect to initiate ~400-patient Phase 3 CD study” Current focus on CAA and 351(k) pathway; CD study not restated in Q4 release Strategy update emphasis

No quantitative revenue, margin, OpEx, OI&E or tax rate guidance was provided; the company focused guidance on regulatory milestones and funding runway .

Earnings Call Themes & Trends

Note: No Q4 earnings call transcript was available in our document set; themes below reflect press releases and 8-K exhibits .

TopicPrevious Mentions (Q2 & Q3)Current Period (Q4)Trend
Regulatory Pathway (351(k) for ABP-450)Q2: planned 351(k) approach; briefed FDA; aimed for single pivotal CD study . Q3: BIA meeting held; aligned on key requirements; planning CAA, subject to capital .Initiated primary analytical studies; pursuing 351(k); BPD Type 2a meeting planned for H2 2025 .Advancing from planning to execution
Comparative Analytical Studies (CAA)Q3: expected to commence in Q4 2024 pending capital .Commenced in Q4 2024 .Milestone achieved
Capital & LiquidityQ3: “single biggest limitation” remains capital resources .Post-quarter $20.0M offering; runway through 2025 .Improving
NYSE Listing/Compliancen/a in Q2/Q3 releases.Reverse split approved/effected (Feb 2025); NYSE below-compliance notice; plan to regain compliance .Addressing compliance risk
Clinical Strategy (CD Phase 3)Q2: expected initiation of ~400-patient CD study .Emphasis on CAA and biosimilar pathway; CD study not restated .Strategy emphasis shift

Management Commentary

  • “We are excited to move ahead with our biosimilar development program for ABP-450 under the 351(k) regulatory pathway utilizing BOTOX as the reference product. As part of this program, we initiated the primary analytical studies in the fourth quarter of 2024.” — Marc Forth, CEO .
  • “We are excited by the progress… The financing we closed in January provided the critical funding that will allow us to work through our Biosimilar BPD Type 2a meeting with FDA.” — Marc Forth, CEO .
  • “The next key step… initiation of our planned primary comparative analytical studies… As we evaluate our path forward, the single biggest limitation… remains our current capital resources.” — Marc Forth, CEO (Q3) .
  • “We expect to have a clear path forward to initiate a single pivotal study directly comparing ABP-450 to BOTOX in the treatment of CD.” — Marc Forth, CEO (Q2) .

Q&A Highlights

  • No Q4 2024 earnings call transcript was available in the filings/press release catalog; management commentary is derived from prepared remarks in press releases and 8-K exhibits .

Estimates Context

  • S&P Global consensus for Q4 2024 EPS and revenue was unavailable; as a clinical-stage issuer without product revenue, coverage appears limited. Values retrieved from S&P Global.*

Where estimates may need to adjust:

  • With the pivot to the 351(k) biosimilar pathway and the initiation of comparative analytics (rather than near-term product revenue), any estimates premised on clinical trial initiation/near-term commercialization timelines should reflect the updated regulatory cadence (CAA completion → BPD Type 2a meeting in H2 2025) .

Key Takeaways for Investors

  • The quarter’s profitability was non-operational in nature; headline EPS and net income are driven by fair value changes (contingent consideration, warrants, convertible notes), not revenue traction — interpret EPS volatility cautiously for valuation .
  • Execution on the 351(k) biosimilar pathway is progressing, with Q4 analytical studies initiated and a defined FDA touchpoint in H2 2025; this pathway could enable a single approval covering all BOTOX therapeutic indications, expanding addressable market if successful .
  • Liquidity risk moderated post-quarter via the $20.0M raise, with management stating funding through 2025; near-term milestones appear financed (CAA completion, BPD Type 2a meeting) .
  • Listing/compliance overhang remains until NYSE plan acceptance and execution; reverse split has been effected to support compliance — monitor milestones against the August 2026 deadline .
  • Strategic emphasis has shifted from near-term Phase 3 CD initiation (Q2 plan) to completing comparative analytics and advancing the biosimilar regulatory pathway first; timelines and capital allocation should be re-underwritten accordingly .
  • With no revenue and limited sell-side coverage, stock moves are likely catalyzed by regulatory updates (CAA results, FDA meetings), financing actions, and listing developments rather than quarterly fundamentals .
  • For trading, key catalysts in 2025 include CAA outcomes and the BPD Type 2a meeting in H2; financing execution and any updates on the CD clinical plan could also re-rate sentiment .