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CI

Celularity Inc (CELU)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 disclosure was delayed: Nasdaq notified Celularity on May 28 that the company had not timely filed its Form 10‑Q for the quarter ended March 31, 2025, with 60 days granted to submit a compliance plan .
  • Despite limited Q1-specific disclosures, S&P Global data indicates revenue of $11.43M* and diluted EPS of $(0.84); sequentially, revenue declined from $18.13M in Q4 2024 while gross margin improved to 68.9%* (mix/cost factors) .
  • Full-year 2024 results showed strong momentum: net revenues were $54.2M (+138.1% YoY) driven by wound care product sales and Biovance® strength, providing a positive setup entering 2025 .
  • Regulatory tailwinds: CMS delayed the LCD effective date for skin substitutes to January 1, 2026, preserving Medicare patient access and provider reimbursement—supportive for Celularity’s wound care products .
  • Corporate developments: the CFO was terminated without cause on June 10; a senior finance executive was appointed interim CFO and CFO Squad engaged to bolster SEC reporting and process optimization—near-term governance/process focus is a likely stock narrative .

What Went Well and What Went Wrong

What Went Well

  • Regulatory environment improved: CMS revised the LCD effective date to Jan 1, 2026, averting a near-term reimbursement shock for wound care; management lauded continued patient access and the opportunity for inclusive reform .
  • Portfolio validation: FDA TRG recommendations for Natalin and Acelagraft™ indicated regulation under Section 361 (HCT/P), reinforcing commercialization pathways in chronic wounds; “We are extremely pleased to receive these TRG recommendation letters… will further enable us to build on our commercial momentum” .
  • 2024 momentum: Net revenues grew to $54.2M (+138.1% YoY), with Biovance® “notably strong” and optimism to “gain additional momentum in 2025” per CEO commentary .

What Went Wrong

  • Reporting timeliness: Nasdaq notice for non‑timely Q1 10‑Q filing introduces listing risk and adds near-term execution scrutiny .
  • Governance turnover: CFO terminated without cause; interim CFO appointed and external advisors engaged—necessary stabilization but potential investor concern about finance organization continuity .
  • Sequential deceleration: Q1 2025 revenue fell to $11.43M* from $18.13M* in Q4 2024; net loss widened to $(19.75)M*—offset by improved gross margin, but profitability remains challenged* .

Financial Results

MetricQ3 2024Q4 2024Q1 2025
Revenue ($USD Millions)$9.30M*$18.13M*$11.43M*
Gross Profit ($USD Millions)$5.41M*$10.79M*$7.87M*
Gross Margin (%)58.23%*59.50%*68.90%*
EBITDA ($USD Millions)$(9.63)M*$(7.60)M*$(8.65)M*
EBITDA Margin (%)(103.63%)*(41.90%)*(75.72%)*
EBIT ($USD Millions)$(11.53)M*$(9.47)M*$(10.49)M*
EBIT Margin (%)(124.00%)*(52.24%)*(91.77%)*
Net Income ($USD Millions)$(16.10)M*$(13.29)M*$(19.75)M*
Diluted EPS$(0.73)*$(0.60)*$(0.84)*

Values marked with * retrieved from S&P Global.

Context and disclosures:

  • FY 2024 net revenues: $54.2M (+138.1% YoY), driven by wound care product sales .
  • Q1 2025 8‑K 2.02 specific to the quarter was not furnished; a May 9 8‑K furnished full-year 2024 results under Item 2.02 .
  • Nasdaq Notice of Q1 10‑Q non‑filing on May 28, 2025 .

Segment breakdown (annual reference for mix insight):

  • FY 2024 revenue composition: Product sales $35.34M, Services $5.14M, License/royalty/other $13.74M .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net Sales (Total)FY 2024$50M – $56M$54M – $60MRaised
Advanced Biomaterial Product SalesFY 2024N/A (implied)$49M – $54.5MProvided (detail)
Biobanking Net SalesFY 2024N/A (implied)$5.0M – $5.5MProvided (detail)

Notes:

  • No Q1 2025 explicit guidance update or ranges were furnished in company documents during the period reviewed .

Earnings Call Themes & Trends

No Q1 2025 earnings call transcript was available during the period reviewed.

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Regulatory/LegalFocus on regaining Nasdaq compliance; filed Q3 10‑Q to become current .Raised FY 2024 guidance; noted process improvements to mitigate reporting delays .CMS delayed LCD to 2026; positive for Medicare access and reimbursement .Improving regulatory tailwinds; ongoing reporting rigor.
Product PerformanceNine‑month net revenues $36.1M; product sales up 621% YoY; momentum in advanced biomaterials .Record October net sales; Rebound™ contributed ~$9M expected net sales YTD; guidance raised .Continued portfolio validation via TRG; Biovance® cited as a growth driver in FY commentary .Sustained demand; mix supportive.
Reporting/ComplianceReturned to current quarterly filings as of Dec 6 .Emphasized reporting improvements and auditor coordination .Nasdaq notice for late Q1 10‑Q; 60‑day plan window .Deterioration in timeliness; remediation underway.
Finance/OrganizationN/AN/ACFO terminated; interim CFO appointed; CFO Squad engaged to strengthen reporting/processes .Transition period; potential stabilization.
Strategic/GeographicEvaluating Asia Pacific opportunities with Genting .Continued exploration in regenerative/cellular medicine .Leverage unique platform and 2025 momentum .Consistent strategic messaging.

Management Commentary

  • “We built momentum through 2024 and ended the year with a strong finish, as reflected in higher net revenues from the sale of our commercial‑stage advanced biomaterial products… Sales growth was notably strong for our Biovance® product line, which we believe will continue to contribute to an improving revenue outlook for the next several quarters.” — Dr. Robert Hariri, CEO .
  • “We applaud the leadership of CMS Administrator Dr. Mehmet Oz to ensure continued access to these critical wound care products… This action preserves patient access and allows CMS time to work with relevant stakeholders to shape payment system improvements…” — Dr. Robert Hariri .
  • “We are extremely pleased to receive these TRG recommendation letters… which serves as a further testament to our commitment to innovate in the wound care sector and will further enable us to build on our commercial momentum.” — Dr. Robert Hariri .

Q&A Highlights

  • No Q1 2025 earnings call transcript was available; therefore no Q&A disclosures were identified in company documents .

Estimates Context

MetricPeriodConsensus (S&P Global)Actual
Revenue ($USD)Q1 2025Unavailable$11.43M*
EBITDA ($USD)Q1 2025Unavailable$(8.65)M*
Primary EPSQ1 2025Unavailable$(0.84)*

Values marked with * retrieved from S&P Global.
S&P Global consensus fields for Q1 2025 were unavailable in our retrieval; no # of estimates surfaced [GetEstimates].

Implication: With consensus visibility limited and formal Q1 disclosure delayed, the sell-side may recalibrate models once the Q1 10‑Q is filed; coverage breadth may also affect near-term estimate dispersion .

Key Takeaways for Investors

  • Near-term setup reflects mixed signals: strong FY 2024 momentum in wound care and Biovance® vs. delayed Q1 reporting and CFO transition—expect heightened focus on governance/process remediation .
  • Reimbursement tailwind is material: CMS LCD delay to 2026 reduces risk of an abrupt Medicare coverage change, supportive for advanced biomaterial demand and revenue continuity in 2025 .
  • Portfolio and regulatory validation (TRG recommendations) underpin market access for Natalin and Acelagraft™, reinforcing commercialization in chronic wound indications .
  • Sequential Q1 softness: revenue down vs. Q4 with improved gross margin—monitor mix (e.g., product vs. license/royalty) and unit economics once the 10‑Q provides detail* .
  • Watch listing/compliance milestones: a timely and credible compliance plan to Nasdaq, 10‑Q filing, and audit cadence will be immediate stock narrative drivers .
  • Execution priorities: stabilize finance function (interim CFO, CFO Squad), maintain operating discipline, and convert regulatory tailwinds into sustained sales growth .
  • Model updates: Given lack of consensus data for Q1, await formal filing to update revenue/EBITDA/EPS trajectories and assess whether FY 2025 trends align with FY 2024 momentum* .

Citations:

  • Nasdaq late filing notice for Q1 2025 Form 10‑Q .
  • FY 2024 operating and financial results and Biovance® commentary .
  • CMS LCD effective date revision to January 1, 2026 .
  • FDA TRG recommendations for Natalin and Acelagraft™ .
  • CFO transition and engagement of CFO Squad .

Values marked with * retrieved from S&P Global.