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AS

ALIMERA SCIENCES INC (ALIM)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 net revenue was $23.0M (+70% YoY), with U.S. revenue +92% to $14.6M and International +42% to $8.5M; global end-user demand rose 23% to 4,028 units .
  • Adjusted EBITDA turned positive to $1.8M, but operating income swung to a loss as OpEx scaled with the expanded U.S. commercial footprint and amortization from the YUTIQ acquisition; GAAP net loss was $6.3M .
  • Management reiterated 2024 guidance: ~$105M net revenue and at least 20% adjusted EBITDA margin, supported by ongoing integration of YUTIQ, international demand and NICE’s phakic-eye access decision for ILUVIEN in the UK .
  • Catalysts: NICE final guidance (UK) expanding ILUVIEN access to phakic DME patients, Protocol AL first patient randomized, and Synchronicity study enrollment completion; these broaden addressable use-cases and support growth narratives .

What Went Well and What Went Wrong

What Went Well

  • Strong top-line growth: Net revenue +70% YoY driven by YUTIQ in the U.S. and international demand/restocking; U.S. +92% to $14.6M and International +42% to $8.5M .
  • Positive adjusted EBITDA turnaround: $1.8M vs. $(2.4)M YoY; management reiterated full-year ≥20% margin target .
  • Regulatory and clinical momentum: “NICE recommended that chronic DME patients with a natural lens gain access to ILUVIEN in the United Kingdom” and “first patient randomized in Protocol AL…; completed enrollment in Synchronicity” .
    Quote: “We continue to integrate YUTIQ into our U.S. business and support the acceleration of growth in international markets… achieve $105 million in revenue and at least 20% EBITDA margins this year” – CEO Rick Eiswirth .

What Went Wrong

  • Operating leverage not yet realized: Total OpEx rose to ~$22.0M (+$7.2M YoY) on commercial expansion and incremental amortization, pressuring operating income (loss from operations of $(2.3)M) .
  • GAAP net loss widened to $(6.3)M vs. $(5.0)M YoY driven by higher interest expense and amortization post-YUTIQ acquisition .
  • Seasonality and execution constraints: Media transcript highlights that Q1 revenue was below Q4 due to deductible resets and benefit verification, and the sales force faces time constraints to deliver dual-product messaging; company introduced a value program to address adoption patterns .

Financial Results

MetricQ3 2023Q4 2023Q1 2024
Net Revenue ($USD Millions)$23.364 $26.306 $23.011
COGS excl. D&A ($USD Millions)$2.758 $3.626 $3.353
Gross Profit ($USD Millions)$20.606 $22.680 $19.658
Gross Margin (%)88.2% (calc. from )86.2% (calc. from )85.5% (calc. from )
Total Operating Expenses ($USD Millions)$18.752 $21.956 $21.960
Operating Income ($USD Millions)$1.854 $0.724 $(2.302)
GAAP Net Loss ($USD Millions)$(1.354) $(3.781) $(6.251)
Diluted EPS ($USD)$(0.06) $(0.07) $(0.12)
Adjusted EBITDA ($USD Millions)$5.418 $5.030 $1.804
Cash and Cash Equivalents ($USD Millions)$8.285 $12.058 $14.314

Segment revenue breakdown:

SegmentQ3 2023Q4 2023Q1 2024
U.S. Net Revenue ($USD Millions)$18.1 $19.2 $14.6
International Net Revenue ($USD Millions)$5.3 $7.1 $8.5

KPIs:

KPIQ3 2023Q4 2023Q1 2024
U.S. End User Units (ILUVIEN + YUTIQ)2,191 (1,145 ILUVIEN + 1,046 YUTIQ) 2,065 (fluocinolone implants) n/a
International End User Units1,265 1,464 n/a
Global End User Demand (Units)3,456 (calc. from )3,529 (calc. from )4,028

Vs. estimates (consensus):

MetricActual (Q1 2024)ConsensusBeat/Miss
Revenue ($USD Millions)$23.011 $22.25 (media) +$0.76M (Beat)
EPS ($USD, GAAP)$(0.12) $(0.11) (media) $(0.01) (Miss)

Note: S&P Global consensus estimates were unavailable for ALIM due to a mapping issue; media-reported consensus is used above with source citations. SPGI data unavailable.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net RevenueFY 2024“Over $105M” (raised in Mar) “$105M” reiterated Maintained
Adjusted EBITDA MarginFY 2024“>20%” “At least 20%” reiterated Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2023 and Q4 2023)Current Period (Q1 2024)Trend
YUTIQ Integration in U.S.Successful integration; expanded sales force to 35 territories Continued integration and U.S. scaling cited as growth driver Execution continuing
International Demand & Distributor StockingDirect market end-user demand +20.4%; distributors rationed due to deferred shipments International revenue +42% on demand + restocking Improving inventory/demand
NICE Phakic DME Access (UK)Not highlightedNICE final guidance expands ILUVIEN access to phakic patients Regulatory tailwind
Clinical: NEW DAY / Synchronicity / Protocol ALNEW DAY enrollment completed; Synchronicity active; CALM completed Synchronicity enrollment completed; first patient randomized in Protocol AL Advancing clinical execution
Seasonality & Practice EconomicsNot highlightedMedia transcript notes Q1 seasonal headwinds vs Q4 (deductibles reset, benefit verification) Recognized headwind
Financing & LiquidityCash targeted to improve; expectation for positive cash flow Increased term loan with SLR by $5M; cash rose to $14.3M Liquidity strengthened

Management Commentary

  • “Our results… provide further confidence in our ability to achieve $105 million in revenue and at least 20% EBITDA margins this year.” – Rick Eiswirth, CEO .
  • “This quarter provided some key clinical milestones… completion of enrollment in the Synchronicity Study… first patient randomized in the DRCR Retina Network study (Protocol AL)…” .
  • “NICE recommended that chronic DME patients with a natural lens gain access to ILUVIEN in the United Kingdom.” .

Q&A Highlights

  • Dual-product messaging challenges: Management acknowledged clinic time constraints to cover both ILUVIEN and YUTIQ; focus is on earlier intervention narratives to streamline adoption .
  • Value program initiation: As of April 1, a nonclinical value program aims to incentivize consistent use by practices, potentially shifting purchasing patterns favorably .
  • Protocol AL funding: Company contribution approximates $1M over 4–5 years ($250k annually), supporting radiation retinopathy use-case exploration .
  • U.S. commercial footprint: 35 U.S. territories reported, aligned with growth plans .

Estimates Context

  • S&P Global consensus (EPS/Revenue) was unavailable for ALIM this quarter due to a mapping issue; therefore, formal SPGI comparisons cannot be presented. SPGI data unavailable.
  • Media consensus indicated GAAP EPS of $(0.11) vs. actual $(0.12) (miss), and revenue consensus of ~$22.25M vs. actual $23.01M (beat). Note: EPS discrepancy may reflect methodology and rounding; the company-reported GAAP diluted EPS was $(0.12) .

Key Takeaways for Investors

  • Commercial growth is durable: YUTIQ integration and international demand/restocking drove broad-based revenue acceleration; positive adjusted EBITDA confirms early operating leverage despite heavier OpEx .
  • Near-term headwinds are manageable: Recognized Q1 seasonality and higher amortization/interest post-acquisition weighed on GAAP profitability; expect quarterly variability as programs normalize .
  • Regulatory and clinical catalysts expanding TAM: NICE phakic-eye guidance and Protocol AL progress broaden ILUVIEN’s potential use-cases, supporting medium-term growth vectors .
  • Liquidity improved with SLR facility increase and growing cash balance; balance sheet capacity supports ongoing commercial and clinical execution .
  • Guidance credibility intact: Reiterated ~$105M revenue and ≥20% adjusted EBITDA margin for FY24; watch quarterly cadence and execution in U.S. territories to confirm trajectory .
  • Estimate models likely to adjust: With SPGI data unavailable and media showing a small EPS miss but revenue beat, sell-side models may shift mix assumptions (U.S. vs International) and expense ramp pace; monitor EBITDA margin delivery vs. reiterated ≥20% target .
  • Trading lens: Near-term stock drivers include evidence of U.S. value program uptake, international distributor restocking sustainability, and incremental clinical data flow; regulatory tailwinds (NICE) underpin sentiment.

Notes on Sources and Process

  • Q1 2024 8-K 2.02 press release and full financial statements read in full (Exhibit 99.1 and reconciliations) .
  • Prior quarters’ earnings: Q4 2023 8-K (press release, statements, reconciliation) ; Q3 2023 8-K (press release, statements, reconciliation) .
  • Q1 2024 earnings call transcript: Document retrieval failed due to database inconsistency; transcript content sourced via media sites (Seeking Alpha, Yahoo Finance, MarketScreener) with full URLs as cited .
  • Other relevant Q1 2024 press/news: NICE technology appraisal TA953 (phakic DME guidance) .