Sign in

You're signed outSign in or to get full access.

GC

GLAUKOS Corp (GKOS)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 delivered record revenue of $105.5M (+28% YoY) with non-GAAP gross margin ~82% and materially improved non-GAAP operating loss; full-year revenue was $383.5M (+22% YoY). Management introduced FY2025 revenue guidance of $475–$485M, underpinned by iDose TR ramp, while highlighting LCD and Hydrus royalty headwinds in legacy U.S. stents and FX/competition risks internationally .
  • U.S. glaucoma grew 45% YoY to a Q4 record $56.3M, driven by iDose TR; international glaucoma grew 28% YoY to $27.9M; corneal health was $21.4M, down 2% YoY due to MDRP effects .
  • Balance sheet de-risking: all $287.5M notes retired; ended 2024 with ~$323.6M cash and investments and no debt (plus ~$53M proceeds from capped-call unwind), supporting stepped-up commercialization and pipeline milestones in 2025 (Epioxa NDA under FDA review; iDose TREX Ph2b/3; iDose TR readministration supplement targeted 1H25) .
  • Stock catalysts: iDose TR adoption (MAC J-code processing and professional fee coverage broadening), FY25 revenue outlook, Epioxa regulatory timeline, and clarity on iDose readministration and TRIO timing (targeted 2026) .

What Went Well and What Went Wrong

  • What Went Well

    • iDose-driven U.S. glaucoma acceleration: Q4 U.S. glaucoma net sales hit $56.3M (+45% YoY) as iDose TR adoption broadened amid growing surgeon training and favorable clinical feedback . Quote: “Within our U.S. glaucoma franchise, we delivered record fourth quarter net sales of $56.3 million… driven primarily by growing contributions from iDose TR.”
    • Reimbursement progress: MACs increasingly adjudicating the permanent J-code; three MACs added CPT 0660T professional fees, improving confidence and paving the way for broader utilization through 2025 .
    • International momentum sustained: Q4 international glaucoma sales rose 28% (29% cc), supported by scaled infrastructure; French rebate tailwind aided reported growth (tailwind to sunset in 2025) .
  • What Went Wrong

    • Gross margin pressure and inventory charges: GAAP gross margin ~73% (down vs ~77% Q4’23) due to amortization and an inventory write-down; non-GAAP gross margin ~82% (vs ~84% Q4’23) .
    • U.S. non‑iDose stent headwinds: New MIGS LCDs slowed non‑iDose growth to mid‑single digits in Q4 and are expected to drive flat to down low‑single‑digit non‑iDose growth in 2025; Hydrus royalty expiration adds pressure .
    • 2025 external risks: FX and competitive trialing in Japan/France flagged as potential international headwinds; MDRP continues to weigh on corneal health, which is guided to low single‑digit growth in 2025 .

Financial Results

  • Income statement summary vs prior year, prior quarter, and consensus
MetricQ4 2023Q3 2024Q4 2024Q4 2024 Consensus
Revenue ($M)$82.365 $96.670 $105.499 N/A (S&P Global consensus unavailable)
GAAP Gross Margin %77.1% 76.6% 72.9% N/A
Non-GAAP Gross Margin %83.8% 82.4% 82.3% N/A
SG&A ($M)$63.034 $64.000 $69.003 N/A
R&D ($M)$37.062 $34.746 $36.527 N/A
Operating Loss ($M)$(38.622) $(24.660) $(28.666) N/A
Net Loss ($M)$(36.779) $(21.409) $(33.580) N/A
GAAP Diluted EPS ($)$(0.75) $(0.39) $(0.60) N/A
Non-GAAP Diluted EPS ($)$(0.63) $(0.28) $(0.40) N/A

Note: S&P Global consensus data could not be retrieved at time of request due to vendor rate limits; therefore, consensus cells are N/A.

  • Segment and franchise detail (trend vs prior quarter; YoY commentary provided where disclosed)
SegmentQ3 2024 ($M)Q4 2024 ($M)
U.S. GlaucomaN/A$56.3
International Glaucoma$24.467 $27.869
Corneal Health$20.6 $21.4
Total Net Sales$96.670 $105.499
  • Segment YoY growth (Q4 2024 vs Q4 2023)
SegmentYoY Growth
U.S. Glaucoma+45%
International Glaucoma+27.5% (reported); +28.7% ops
Corneal Health−2%
Total Net Sales+28.1% (reported); +28.4% ops
  • Balance sheet and cash
    • Cash, ST investments, restricted cash: $323.6M at 12/31/24 (vs $267.2M at 9/30/24); no debt after retiring all 2027 converts; $53.2M proceeds from capped call unwind in Q4 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Consolidated Net SalesFY2025N/A$475–$485M New
U.S. Glaucoma (non‑iDose)FY2025N/AFlat to down low‑single‑digits (LCDs, Hydrus royalty expiry) Qualitative
International GlaucomaFY2025N/AHigh single‑digit growth (FX, competitive trialing in JP/FR) Qualitative
Corneal HealthFY2025N/ALow single‑digit growth (MDRP headwind) Qualitative
Seasonality mixFY2025N/AQ1 ~21%, Q2 23–24%, Q3 ~25%, Q4 ~30% Qualitative
iDose TR revenueFY2025N/A“Well north of $100M” implied by guide mix Qualitative

Additional context: MAC J‑code processing is normalizing in a majority of MACs; three MACs now have professional fee schedules for CPT 0660T, which management expects to support adoption through 2025 .

Earnings Call Themes & Trends

TopicQ2 2024 (Prior‑2)Q3 2024 (Prior‑1)Q4 2024 (Current)Trend
iDose TR launch/adoptionRecord revenue; pipeline and initial launch momentum; 2024 guide raised to $370–$376M Record revenue; guide raised to $377–$379M; building toward broader market access iDose cited as key driver; majority of MACs adjudicating J‑code; 3 MACs with pro fee schedules; strong clinical feedback; adoption to build through 2025 Accelerating adoption with improving reimbursement infrastructure
Reimbursement (MAC J‑code, pro fees)J‑code effective July 1, 2024 (context for 2H) “5 of 7 MACs adjudicating J‑code”; 3 MACs have CPT 0660T pro fees; normalization progressing Increasing coverage/operationalization
U.S. stent (non‑iDose)New MIGS LCDs caused Q4 turbulence; expect 2025 flat/down LSD for non‑iDose; Hydrus royalty expires 4/26/25 Near‑term headwind
International glaucomaStrong broad‑based growth; French rebate tailwind +28% Q4; 2025 outlook high single digits; FX and competitive trialing headwinds; French tailwind sunsets Growth moderates on FX/competition
Corneal health (Photrexa/MDRP)Q3 corneal +5% YoY Q4 $21.4M, −2% YoY; MDRP continues; 2025 LSD growth; Epioxa NDA submitted (Dec 23) Navigating MDRP; Epioxa optionality
iDose clinical/RWE36‑month Ph3 analysis shows sustained outcomes; Phase IV combo cataract: mean IOP −11.3 mmHg (−44%) at 6 months; TREX Ph2b/3 initiated Evidence base expanding
iDose readministrationPlan to submit post‑approval supplement in 1H25; 180‑day review target (decision by YE25) Regulatory clarity pending
iDose TRIO (office‑setting)Small safety study mid‑2025; commercial availability targeted 2026 New setting expansion roadmap
FX & macroFX headwinds into 2025 called out; international competition trialing New external headwind

Management Commentary

  • “Glaukos reported record fourth quarter consolidated net sales of $105.5 million, up 28%... Our record performance... reflects our unwavering dedication to advancing our mission to transform vision by pioneering novel dropless platforms...” — Thomas Burns, CEO .
  • “I can now say that 5 of the 7 MACs are adjudicating and processing the J‑code in a normalized and efficient manner… and 3 of the 7 MACs now [have] CPT 0660T in their professional fee schedules…” — Joseph Gilliam, President & COO .
  • “We did see the new LCD restrictions slow our non‑iDose… growth… to mid‑single digits for the quarter… [We] expect… flat to maybe even down low single‑digit growth for our non‑iDose revenues in 2025.” — Joseph Gilliam .
  • “We ended 2024 in a strong capital position with cash and equivalents of roughly $324 million and no debt.” — Thomas Burns .
  • “We’re in a good position now to submit a post‑approval supplement [for iDose readministration]… in the first half of this year… [FDA] 180 days once we submit… should know by the end of this year…” — Thomas Burns .
  • “The iDose TRIO… small safety study mid‑year… expectation is to have… available in 2026… align with MAC reimbursement for in‑office use.” — Thomas Burns .

Q&A Highlights

  • iDose ramp cadence and model impact: Management suggested many models likely saw iDose TR revenues “probably doubling” vs Q3, with macro adoption to build as reimbursement confidence increases through 2025 .
  • Guidance composition: Non‑iDose U.S. glaucoma expected flat/down LSD (LCDs, Hydrus royalty); international HSD growth (FX/competition risk); corneal LSD growth (MDRP); iDose weighted to 2H, especially Q4; seasonality: Q1 ~21%, Q2 23–24%, Q3 ~25%, Q4 ~30% .
  • International outlook/catalysts: High‑single‑digit growth assumed; potential upside on MDR approval for iStent infinite in Europe (timing opaque) .
  • Setting expansion: iDose TRIO to enable smaller incision suitable for office setting; small safety study mid‑2025; commercial availability targeted 2026 .
  • Operational execution: Facilities (ASC vs large hospital systems) show differing adoption velocity; company mitigating inventory carrying costs via longer-dated terms typical for pharma .

Estimates Context

  • S&P Global consensus for Q4 2024 revenue and EPS was unavailable at time of request due to vendor rate limits, so we cannot quantify beats/misses versus Street. Investors should anchor near-term expectations to the company’s FY2025 revenue guidance of $475–$485M and management’s segment commentary on mix and seasonality .

Key Takeaways for Investors

  • iDose TR is the core driver: U.S. glaucoma up 45% YoY in Q4; reimbursement infrastructure (J‑code adjudication, pro fees) is strengthening and should support continued adoption through 2025 .
  • Legacy U.S. stents face near-term headwinds: new LCD restrictions and Hydrus royalty expiration imply flat/down LSD non‑iDose growth in 2025; watch for stabilization beyond 1H .
  • International growth normalizing: after strong 2024, management embeds FX and competition trialing headwinds; base case is high‑single‑digit growth, with potential upside on regulatory wins (e.g., MDR) .
  • Corneal health navigating MDRP: Q4 corneal –2% YoY; 2025 LSD growth—Epioxa (Epi‑on) review through 2025 could reset the 2026 outlook if approved .
  • Pipeline/regulatory catalysts: iDose readministration supplement (submission 1H25; decision by YE25), iDose TRIO (target 2026), iDose TREX Ph2b/3 underway—each can expand addressable use-cases or duration .
  • De‑risked balance sheet enables investment: no debt, ~$323.6M cash/investments, and lower interest expense support commercial scale-up and R&D milestones .
  • Trading setup: focus on iDose utilization trajectory (accounts/surgeons, MAC coverage maturation, pro-fee roll‑in), evidence updates (Phase IV/combo cataract), and quarterly cadence consistent with guidance seasonality .