Glaukos(GKOS) - 2025 Q2 - Quarterly Results

Report Overview & Conference Call Information Important Information This document provides investors with a review of Glaukos Corporation's Q2 2025 financial and operational performance and overall business outlook, including forward-looking statements and non-GAAP financial measures - This document provides investors with a review of Glaukos Corporation's Q2 2025 financial and operational performance and business outlook[1] - Refer to 'Forward-Looking Statements' and 'Statement Regarding Use of Non-GAAP Financial Measures' in the 'Additional Information' section[1] Conference Call Information Glaukos Corporation will host its Q2 2025 earnings conference call on July 30, 2025, providing detailed dial-in and webcast information Q2 2025 Earnings Conference Call Information | Metric | Details | | :--- | :--- | | Date | July 30, 2025 | | Time | 4:30 PM ET / 1:30 PM PT | | Dial-in (U.S.) | 1-800-715-9871 | | Dial-in (International) | 1-646-307-1963 | | Conference ID | 5255602 | | Webcast | Glaukos Investor Relations website (http://investors.glaukos.com) | | Webcast Replay | Archived on the Investor Relations website after the call | SECOND QUARTER 2025 FINANCIAL RESULTS SUMMARY Key Financial and Operational Highlights Glaukos Corporation achieved strong financial performance in Q2 2025, with total revenue reaching $124.1 million, a 30% year-over-year increase, and non-GAAP gross margin improving to approximately 83% Q2 2025 Key Financial Metrics | Metric | Q2 2025 | | :--- | :--- | | Business Description | Ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel, dropless platform therapies to disrupt traditional care standards and improve treatment outcomes for patients with chronic eye diseases | | Disease Categories | Glaucoma, Corneal Health, Retinal Diseases | | Revenue (Growth) | $124.1 million (+30% reported, +29% constant currency vs. Q2 2024) | | Gross Margin (Non-GAAP) | Approximately 83% (vs. approximately 82% in Q2 2024) | | Cash and Cash Equivalents, Short-Term Investments, and Restricted Cash | $278.6 million as of June 30, 2025 (vs. $303.4 million as of March 31, 2025) | | FY2025 Sales Guidance | Expected global consolidated revenue of $480 - $486 million (previously $475 - $485 million) | Revenue Performance & Commercial Overview Global Consolidated Revenue Performance Glaukos achieved record global consolidated net revenue in Q2 2025, driven by the increasing adoption of iDose® TR and broader global Interventional Glaucoma (IG) initiatives - Glaukos reported record net revenue of $124.1 million in Q2 2025, a 30% increase year-over-year (reported basis) or 29% (constant currency basis)[5] - Strong performance was primarily driven by the increasing adoption and utilization of iDose® TR and broader global Interventional Glaucoma (IG) initiatives[5] Franchise Revenue Performance All company franchise businesses showed growth in Q2 2025, with significant growth in U.S. Glaucoma driven by iDose TR, strong international glaucoma growth, and corneal health impacted by Medicaid drug rebate programs U.S. Glaucoma U.S. Glaucoma business achieved record revenue in Q2 2025, primarily due to the strong contribution of iDose TR, which continues to show positive clinical results and surgeon feedback - U.S. Glaucoma net revenue was approximately $72.3 million, a 45% year-over-year increase[9] - iDose TR contributed approximately $31.0 million in sales during Q2[9] - iDose TR continues to demonstrate very positive clinical results and product feedback, with the potential to reshape glaucoma management[10] International Glaucoma International Glaucoma business achieved record revenue in Q2 2025 with broad growth, as the company expands its international infrastructure and promotes MIGS as a standard of care, though new competitive products may pose challenges - International Glaucoma net revenue was approximately $31.3 million, a 20% year-over-year increase (reported basis) or 15% (constant currency basis)[11] - Strong international market growth is broad-based, with the company continuing to expand its international infrastructure and drive MIGS as a standard of care across various regions and key markets[11] - Anticipate increasing headwinds in 2025 as new competitive products are trialed in key international markets[12] Corneal Health Corneal Health business saw revenue growth in Q2 2025, despite the impact of the company's participation in the Medicaid Drug Rebate Program, as Glaukos remains committed to expanding treatment access for keratoconus patients - Corneal Health net revenue was approximately $20.6 million, a 4% year-over-year increase[13] - U.S. Photrexa® net sales were $17.9 million, reflecting the ongoing impact of the company's participation in the Medicaid Drug Rebate Program (MDRP) on Photrexa's actual revenue[13] - The company remains focused on expanding treatment access for keratoconus patients[14] Additional Commercial Updates & Commentary Glaukos made several positive commercial advancements, including iDose TR promotion in the U.S., Epioxa™ FDA approval preparations, iStent infinite® European launch plans, and evaluation of CMS 2026 proposed rules - Advancing U.S. commercial launch activities for iDose TR, including increasing trained surgeons and accounts, expanding utilization among existing surgeons, broadening and streamlining market access, and accelerating marketing investments to enhance patient awareness and education[15] - Progressing Epioxa™ FDA approval and commercial launch preparation plans[15] - Planning for the commercial launch of iStent infinite® in key European markets in September 2025, following receipt of EU Medical Device Regulation (MDR) certification[15] - CMS 2026 Proposed Rules: Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) facility rates proposed to maintain 2025 APC assignments with modest increases in facility rates for related procedures; Physician Fee Schedule (PFS) update proposed to reduce physician reimbursement for certain CPT codes in ophthalmology (including cataract and surgical MIGS) and other specialties[15] 2025 Revenue Guidance Raised to Reflect Strong Momentum Full-Year 2025 Revenue Guidance and Influencing Factors Glaukos raised its full-year 2025 global consolidated net sales guidance, reflecting strong growth momentum and considering potential contributions from iDose TR and iStent infinite, alongside several potential headwinds including challenges in the U.S. glaucoma stent business and transitional impacts on corneal health - Glaukos raised its full-year 2025 global consolidated net sales guidance to $480 million to $486 million, up from the previous guidance of $475 million to $485 million[16] - Guidance factors include: potential contributions from iDose TR and iStent infinite, headwinds in the U.S. glaucoma stent business, potential temporary headwinds from the Photrexa to Epioxa transition, ongoing impact of professional fee reimbursement on U.S. glaucoma sales, expiration of Hydrus® Microstent (Alcon) royalties, headwinds from the company's entry into MDRP for U.S. corneal health, end of growth tailwinds from the French health authority rebate agreement, latest foreign exchange spot rates, global cataract MIGS competition, and global macroeconomic uncertainties[16] Research & Development / Pipeline Overview Pipeline Summary Glaukos' R&D pipeline focuses on five key dropless technology treatment platforms designed to disrupt traditional treatment paradigms and drive future innovation - The company possesses five key dropless technology treatment platforms aimed at disrupting traditional treatment paradigms and generating future innovations[17] - These platforms include: iStent® micro-surgical devices, iDose® sustained-release procedural drugs, iLution™ transdermal drugs, iLink® bio-activated drugs, and Retina XR biodegradable sustained-release drugs[19] Key R&D and Pipeline Updates Glaukos continues to prudently invest over $700 million since 2018 and advance its comprehensive core novel platform pipeline, with recent significant progress in Epioxa FDA review, iStent infinite EU MDR certification, and multiple clinical trial advancements - Since 2018, the company has invested over $700 million in R&D projects[20] - The FDA has accepted the New Drug Application (NDA) for Epioxa (Epi-on), with a PDUFA date of October 20, 2025[20] - iStent infinite and other key trabecular micro-bypass MIGS technologies have received EU MDR certification[20] - Advancements are underway for the iDose TREX Phase 2b/3 clinical program, supplemental label review for iDose TR re-dosing, Phase 4 study for iDose TR, PMA pivotal trial for iStent infinite in mild-to-moderate glaucoma patients, 510(k) pivotal study for PRESERFLO™ MicroShunt, first-in-human clinical development program for Retina XR (GLK-401), and Phase 2 clinical program for third-generation iLink therapies[20] - Phase 2 clinical trial for iLution™ blepharitis is planned to commence by the end of 2025[20] Product / Pipeline Chart Glaukos' pipeline encompasses various ophthalmic treatment solutions from approved to preclinical stages, primarily targeting glaucoma, ocular hypertension, and keratoconus Glaukos Product / Pipeline Overview | Product/Project | Patients | Status | | :--- | :--- | :--- | | iStent inject W | Mild-to-moderate glaucoma with cataract | FDA Approved (2012, 2018, 2020) | | iStent infinite | Glaucoma (previously failed treatment) | FDA Approved (2022) | | iStent infinite | Glaucoma (label expansion) | Active PMA Study / EU MDR Certified (2025) | | PRESERFLO™ MicroShunt | Advanced refractory glaucoma | OUS Approved / U.S. Active IDE Study | | iDose TR | Ocular hypertension - glaucoma | FDA Approved (2023) | | iDose TREX | Ocular hypertension - glaucoma | Phase 2b/3 | | iDose Next-Gen | Ocular hypertension - glaucoma | Preclinical | | iLink (GLK-311) | Ocular hypertension - glaucoma | Phase 2 | | Mitosol® | Glaucoma filtration surgery adjunct | FDA Approved | | Photrexa® | Keratoconus | FDA Approved (2016) | | Epioxa™ | Keratoconus | NDA Submitted; PDUFA Date: October 20, 2025 | | iLution™ | Keratoconus | Phase 2 | | Retina XR (GLK-480) | Keratoconus | Phase 1 | Other Financial Performance Overview Non-GAAP Financial Performance Summary Glaukos reported significantly improved non-GAAP financial results in Q2 2025, with year-over-year gross margin increase and substantial narrowing of operating and net losses, reflecting ongoing investments in commercial and R&D initiatives Q2 2025 Non-GAAP Financial Performance Summary | Metric | Q2 2025 | Q2 2024 | Y/Y Change | | :--- | :--- | :--- | :--- | | Gross Margin (Non-GAAP) | 83% | 82% | +80 bps | | Sales, General and Administrative Expenses (Non-GAAP) | $83.1 million | $65.5 million | +27% | | Research and Development Expenses (Non-GAAP) | $36.5 million | $34.4 million | +6% | | Total Operating Expenses (Non-GAAP) | $119.6 million | $99.9 million | +20% | | Operating Loss (Non-GAAP) | ($16.6 million) | ($23.7 million) | Improved $7.1 million | | Net Loss (Non-GAAP) | ($13.6 million) | ($26.3 million) | Improved $12.7 million | | Diluted Loss Per Share (Non-GAAP) | ($0.24) | ($0.52) | Improved $0.28 | | Capital Expenditures | $1.2 million | $2.1 million | ($1.0 million) | | Cash and Cash Equivalents, Short-Term Investments, and Restricted Cash | $278.6 million (as of June 30, 2025) | $303.4 million (as of March 31, 2025) | Sequentially decreased $24.8 million | - Sales, general and administrative expenses increased year-over-year and sequentially, primarily reflecting investments in global commercial and administrative expenses, new product launch activities, and a one-time $3.3 million stock-based compensation expense in Q2 2025 triggered by certain performance awards[22] - Research and development expenses increased year-over-year and sequentially, reflecting continued investment and advancement in R&D programs[22] - Cash and cash equivalents, short-term investments, and restricted cash sequentially decreased by $24.8 million, including $12.6 million (net) paid for the acquisition of Mobius Therapeutics and $16.6 million paid for the purchase of an Aliso Viejo headquarters building[22] Other Important Updates Strategic Business Developments Glaukos strengthened its supply chain and advanced glaucoma treatment capabilities in Q2 2025 through the acquisition of Mobius Therapeutics and investment in headquarters infrastructure, anticipating minimal direct impact from recent tariff policies due to primarily U.S. manufacturing and sourcing - Completed a small acquisition of Mobius Therapeutics in Q2, whose primary product Mitosol® is the only FDA-approved mitomycin-C ophthalmic formulation for use as an adjunct to trabeculectomy for advanced glaucoma[23] - This acquisition helps consolidate the supply chain and supports the company's broader advanced glaucoma tertiary care efforts[23] - Continued operational investments to support long-term growth plans by purchasing an additional building at the Aliso Viejo headquarters campus[23] - The company primarily manufactures and sources products in the U.S., expecting minimal direct impact from recent tariff-related policies[23] Additional Information & Financial Reconciliations Forward-Looking Statements This section contains forward-looking statements as defined by federal securities laws, reminding investors that these statements are based on management's current expectations and are subject to risks, uncertainties, and factors that could cause actual results to differ materially from expectations - This communication contains 'forward-looking statements' as defined under federal securities laws, covering the company's expectations, beliefs, or projections regarding future activities, events, or developments[26] - These statements are based on management's current expectations, assumptions, estimates, and beliefs, but are subject to risks, uncertainties, and factors that could cause actual results to differ materially from forward-looking statements[26] - Potential risks and uncertainties include commercialization capabilities, macroeconomic conditions, product sales and development capabilities, reliance on third-party suppliers, operational disruptions, reimbursement coverage, surgeon training, regulatory compliance, clinical trial results, product safety issues, cybersecurity threats, intellectual property protection, and debt repayment ability[26] Statement Regarding Use of Non-GAAP Financial Measures The company uses non-GAAP financial measures to supplement GAAP financial results, better reflect core operating activities, enhance comparability with peers, and exclude items inconsistent in amount or frequency, also presenting net sales information on a constant currency basis to eliminate exchange rate fluctuations - The company uses non-GAAP historical financial measures to supplement GAAP consolidated financial results, reflecting core operating activities, enhancing comparability with peers, and excluding items inconsistent in amount or frequency[27] - Non-GAAP adjustments include external acquisition-related costs, intangible asset amortization, goodwill and intangible asset impairment, certain in-process research and development expenses, fair value adjustments to contingent consideration liabilities, integration and transition costs related to business combinations, inventory fair value adjustments, restructuring charges, non-recurring inventory write-downs, gains/losses on business divestitures, mark-to-market adjustments for derivatives, significant legal settlement costs/settlement charges, expenses related to convertible senior notes, and significant discrete income tax adjustments[27] - To eliminate the impact of foreign exchange rate fluctuations, the company also presents certain net sales information on a constant currency basis[28] GAAP Income Statement Glaukos Corporation's condensed consolidated income statement shows significant net sales growth in Q2 2025, but the company remains in a net loss position, although the loss narrowed year-over-year Glaukos Corporation Condensed Consolidated Statements of Operations (Unaudited) | Metric (in millions) | Q2 2025 | Q2 2024 | YTD Q2 2025 | YTD Q2 2024 | | :--- | :--- | :--- | :--- | :--- | | Net Sales | $124.1 million | $95.7 million | $230.8 million | $181.3 million | | Cost of Sales | 26,896 | 22,550 | 51,212 | 42,808 | | Gross Profit | 97,224 | 73,140 | 179,572 | 138,504 | | Sales, General and Administrative Expenses | 83,375 | 66,188 | 154,048 | 128,163 | | Research and Development Expenses | 36,538 | 34,426 | 68,891 | 65,152 | | Acquired In-Process Research and Development Expenses | — | $2.5 million | — | $14.2 million | | Total Operating Expenses | 119,913 | 103,114 | 222,939 | 207,544 | | Operating Loss | (22,689) | (29,974) | (43,367) | (69,040) | | Net Loss | (19,657) | (50,545) | (37,803) | (91,383) | | Basic and Diluted Net Loss Per Share | ($0.34) | ($1.00) | ($0.66) | ($1.82) | GAAP Balance Sheet Glaukos Corporation's consolidated balance sheet shows a slight increase in total assets as of June 30, 2025, with a decrease in cash and cash equivalents but an increase in short-term investments, while total liabilities and shareholders' equity remained relatively stable Glaukos Corporation Condensed Consolidated Balance Sheets (Unaudited) | Metric (in millions) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and Cash Equivalents | $100.8 million | $169.6 million | | Short-Term Investments | $174.0 million | $149.3 million | | Accounts Receivable, Net | 82,985 | 60,744 | | Inventory | 64,621 | 57,678 | | Prepaid Expenses and Other Current Assets | 13,673 | 12,455 | | Total Current Assets | 436,065 | 449,792 | | Restricted Cash | 3,834 | 4,733 | | Property and Equipment, Net | 111,816 | 97,867 | | Intangible Assets, Net | 270,491 | 263,445 | | Goodwill | 66,710 | 66,134 | | Total Assets | 986,958 | 974,756 | | Liabilities and Stockholders' Equity | | | | Accounts Payable | 13,684 | 13,026 | | Accrued Liabilities | 65,452 | 62,099 | | Total Current Liabilities | 79,136 | 75,125 | | Operating Lease Liabilities | 36,200 | 33,936 | | Finance Lease Liabilities | 68,823 | 69,463 | | Deferred Tax Liabilities, Net | 6,910 | 6,928 | | Other Liabilities | 30,777 | 22,373 | | Total Liabilities | 221,846 | 207,825 | | Total Stockholders' Equity | 765,112 | 766,931 | | Total Liabilities and Stockholders' Equity | 986,958 | 974,756 | Primary GAAP to Non-GAAP Reconciliations This section provides detailed reconciliations of Glaukos Corporation's GAAP and non-GAAP financial measures for Q2 and H1 2025, highlighting the impact of adjustments for acquisition-related amortization, transaction costs, and convertible senior notes on gross margin, operating loss, and net loss Q2 2025 GAAP to Non-GAAP Reconciliations (in millions) | Metric | GAAP (Q2 2025) | Adjustments (Q2 2025) | Non-GAAP (Q2 2025) | GAAP (Q2 2024) | Adjustments (Q2 2024) | Non-GAAP (Q2 2024) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Cost of Sales | 26,896 | ($5.8 million) (a)(b) | 21,132 | 22,550 | ($5.5 million) (a) | 17,027 | | Gross Margin | 78.3% | 4.7% | 83.0% | 76.4% | 5.8% | 82.2% | | Sales, General and Administrative Expenses | 83,375 | ($0.3 million) (c) | 83,080 | 66,188 | ($0.7 million) (d) | 65,483 | | Operating Loss | (22,689) | 6,059 | (16,630) | (29,974) | 6,228 | (23,746) | | Convertible Senior Notes Related Expenses | — | — | — | ($18.0 million) | $18.0 million (e) | — | | Net Loss | (19,657) | 6,059 (f) | (13,598) | (50,544) | 24,240 (f) | (26,304) | | Basic and Diluted Net Loss Per Share | ($0.34) | 0.10 | ($0.24) | ($1.00) | 0.48 | ($0.52) | - Cost of sales adjustments primarily relate to developed technology intangible asset amortization from the Avedro acquisition ($5.5 million for both Q2 2025 and Q2 2024) and developed intellectual property and distribution rights amortization from the Mobius acquisition ($0.2 million for Q2 2025)[33][34] - Sales, general and administrative expense adjustments include transaction costs related to the Mobius acquisition ($0.3 million for Q2 2025) and customer relationship intangible asset amortization from the Avedro acquisition ($0.7 million for Q2 2024)[34] - Convertible senior notes related expense adjustments include $17.4 million in non-cash inducement expense and $0.6 million in direct transaction costs[34] H1 2025 GAAP to Non-GAAP Reconciliations (in millions) | Metric | GAAP (YTD Q2 2025) | Adjustments (YTD Q2 2025) | Non-GAAP (YTD Q2 2025) | GAAP (YTD Q2 2024) | Adjustments (YTD Q2 2024) | Non-GAAP (YTD Q2 2024) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Cost of Sales | 51,212 | ($11.3 million) (a)(b) | 39,925 | 42,808 | ($11.0 million) (a) | 31,762 | | Gross Margin | 77.8% | 4.9% | 82.7% | 76.4% | 6.1% | 82.5% | | Sales, General and Administrative Expenses | 154,048 | ($0.3 million) (c) | 153,753 | 128,163 | ($1.4 million) (d) | 126,753 | | Operating Loss | (43,367) | 11,582 | (31,785) | (69,040) | 12,456 | (56,584) | | Convertible Senior Notes Related Expenses | — | — | — | ($18.0 million) | $18.0 million (e) | — | | Net Loss | (37,803) | 11,582 (f) | (26,221) | (91,382) | 30,468 (f) | (60,914) | | Basic and Diluted Net Loss Per Share | ($0.66) | 0.20 | ($0.46) | ($1.82) | 0.61 | ($1.21) | - H1 cost of sales adjustments primarily relate to developed technology intangible asset amortization from the Avedro acquisition ($11.0 million for both H1 2025 and H1 2024) and developed intellectual property and distribution rights amortization from the Mobius acquisition ($0.2 million for H1 2025)[36][37] - H1 sales, general and administrative expense adjustments include transaction costs related to the Mobius acquisition ($0.3 million for H1 2025) and customer relationship intangible asset amortization from the Avedro acquisition ($1.4 million for H1 2024)[37] Additional GAAP to Non-GAAP Reconciliations (Constant Currency) This section provides reconciliations of year-over-year and sequential changes in international glaucoma and total net sales on reported, operational, and constant currency bases, to clearly illustrate the impact of exchange rate fluctuations on revenue growth Reported Sales vs. Prior Period (in millions) | Metric | Q2 2025 | Q2 2024 | Q1 2025 | Y/Y Change (Reported) | Y/Y Change (Operational) | Y/Y Change (FX) | Q/Q Change (Reported) | Q/Q Change (Operational) | Q/Q Change (FX) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | International Glaucoma | $31.3 million | $26.1 million | $29.0 million | 19.6% | 15.5% | 4.1% | 7.7% | 2.1% | 5.6% | | Total Net Sales | $124.1 million | $95.7 million | $106.7 million | 29.7% | 28.6% | 1.1% | 16.4% | 14.8% | 1.6% | - Operational growth excludes the impact of foreign currency translation[40] - Foreign exchange impact is calculated by converting current period data using prior period average foreign exchange rates[40]