Name: AEON Biopharma, Inc. Q2 2025 Earnings Call
Start: 2025-08-12T00:00:00.000Z

Executive Summary

AEON reported Q2 2025 net loss of $6.642M and diluted EPS of $(0.60), reflecting a pre-revenue profile with operating expenses and fair value changes driving results .
Management tightened the regulatory timeline: completion of primary structure and select functional analyses now expected in Q3’25, with a Type 2a FDA meeting anticipated in Q4’25; cash runway is expected to fund operations through the FDA meeting and regulatory feedback .
Liquidity at quarter-end was $8.439M in cash and equivalents; total assets were $11.662M and total liabilities $27.514M, implying continued need for external capital beyond the Q4’25 milestone window .
Wall Street consensus estimates (EPS, revenue) via S&P Global were unavailable for Q2 2025, limiting beat/miss framing; narrative catalysts center on biosimilarity data readouts in Q3’25 and the Q4’25 FDA Type 2a meeting .

What Went Well and What Went Wrong

AEON advanced its biosimilar development program for ABP-450, with management stating: “We are poised to report the results from our primary structure analysis and select functional analyses…critical components of our planned Type 2a meeting with the FDA…anticipated to take place in 4Q’25” .
Strategy clarity: “By utilizing the 351(k) pathway, we aim to bring ABP-450 to the U.S. market under a single FDA approval that could cover all of BOTOX’s currently approved and future therapeutic indications” .
Market opportunity affirmed: “The over $3.0 billion U.S. therapeutic market remains controlled by a single toxin, and we believe our entry into the market would be welcomed by stakeholders” .

Pre-revenue operating model persists; results driven by operating expenses (SG&A $3.258M; R&D $1.064M) and non-operating fair value items rather than product revenue .
Non-operating headwinds: change in fair value of convertible notes was $(1.854)M and warrants $(0.542)M, pressuring bottom-line results in Q2 2025 .
Limited liquidity: cash and equivalents of $8.439M at 6/30/25 imply a constrained runway beyond Q4’25 milestones without additional financing .

Metric	Q2 2024	Q1 2025	Q2 2025
Net (Loss) Income ($M)	$164.112	$9.095	$(6.642)
Diluted EPS ($)	$304.00	$2.28	$(0.60)
SG&A ($M)	$3.321	$3.125	$3.258
R&D ($M)	$4.439	$0.825	$1.064
Change in FV – Convertible Notes ($M)	$1.795	$(1.631)	$(1.854)
Change in FV – Warrants ($M)	$5.905	$86.729	$(0.542)
Loss on Issuance of Warrants ($M)	—	$(75.644)	—
Weighted Avg Shares (Diluted) (#)	539,840	3,984,876	11,090,809

Notes:

No revenue line was reported in the Q2 2025 and Q2 2024 income statements; focus remains on R&D/SG&A and fair value items .
The large YoY swing in net income reflects non-operating fair value effects in prior-year periods .

Metric	Dec 31, 2024	Mar 31, 2025	Jun 30, 2025
Cash & Equivalents	$0.013	$10.446	$8.439
Total Assets	$3.142	$13.799	$11.662
Total Current Liabilities	$14.149	$8.640	$9.129
Convertible Notes (FV)	$11.689	$13.320	$15.174
Warrant Liability	$1.187	$2.026	$2.122
Contingent Consideration	$3.541	$0.053	$0.069
Total Liabilities	$31.711	$25.122	$27.514
Total Stockholders’ Deficit	$(28.569)	$(11.323)	$(15.852)

Metric	Period	Previous Guidance	Current Guidance	Change
FDA Type 2a Meeting Timing	H2 2025	Planned in H2 2025	Anticipated in Q4’25	Narrowed timing (maintained overall)
Primary Structure & Select Functional Analyses	2025	Studies in progress; timing not specified	Expected completion in Q3’25	Added specific timeline (raised clarity)
Cash Runway	Through Q4 2025	Expected to fund operating plan through Q4 2025	Expected to support operations through Q4’25 and regulatory feedback	Maintained

No quantitative guidance provided for revenue, margins, OpEx ranges, OI&E, or tax rate .

(No Q2 2025 earnings call transcript was available in our document set.)

Topic	Previous Mentions (Q4 2024 and Q1 2025)	Current Period (Q2 2025)	Trend
Regulatory Path (351(k) Biosimilar)	Initiated primary analytical studies; aligned on key 351(k) requirements	Emphasizing CAA framework; aligned on initial key requirements	Steady progress
Analytical Milestones	Q4’24: studies commenced ; Q1’25: studies ongoing	Completion of primary structure and select functional analyses expected in Q3’25	Clearer timeline
FDA Interaction	Plan for BPD Type 2a in H2’25	Type 2a meeting anticipated Q4’25	Narrowed timing
Liquidity/Runway	Jan’25 financing closed; runway through 2025	Cash expected to fund operations through Q4’25 meeting and feedback	Maintained runway
Market Opportunity	Therapeutic toxin market ~$3.3B global	U.S. therapeutic market >$3.0B; single-toxin control; biosimilar entry opportunity	Narrative consistent
Manufacturing/Partner Data	Daewoong cGMP manufacturing; supportive preclinical tox data	Supportive tox/manufacturing data backing CAA and FDA meeting	Reinforced

“We are poised to report the results from our primary structure analysis and select functional analyses for ABP-450…critical components of our planned Type 2a meeting with the FDA, anticipated to take place in 4Q’25.” — Rob Bancroft, CEO .
“By utilizing the 351(k) pathway, we aim to bring ABP-450 to the U.S. market under a single FDA approval that could cover all of BOTOX’s currently approved and future therapeutic indications.” — Rob Bancroft .
“We believe ABP-450 has the potential to offer a more cost-effective solution that would enhance patient access and improve economics for both payers and healthcare providers.” — Rob Bancroft .

No Q2 2025 earnings call transcript was available in our document set; therefore, no Q&A themes or clarifications can be reported for this quarter.

S&P Global consensus estimates for AEON’s Q2 2025 EPS and revenue were unavailable when queried; as such, beat/miss analysis versus Street is not possible for this period.

The quarter’s significance is regulatory: Q3’25 analytical completions and the Q4’25 FDA Type 2a meeting are the primary catalysts; stock reaction likely hinges on the robustness of comparative analytical data and FDA feedback .
Liquidity sits at $8.439M with total liabilities of $27.514M, implying potential need for financing beyond Q4’25 milestones if development continues apace .
Results remain driven by operating expenses and fair value adjustments, with diluted EPS at $(0.60) and no product revenue recognized; investors should focus on milestone execution rather than near-term P&L .
The strategic promise is notable: potential full-label biosimilarity under 351(k) for the >$3.0B U.S. therapeutic neurotoxin market dominated by a single product, positioning ABP-450 as a cost-effective alternative upon approval .
Watch for preclinical/manufacturing support and the completeness of the comparative analytical assessment as de-risking steps ahead of the FDA meeting .
Near-term trading lens: outcomes from Q3’25 analyses and any 8-K/press disclosures can serve as pre-FDA catalysts; absence of consensus estimates may amplify volatility around qualitative disclosures.