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Glaukos(GKOS) - 2025 Q2 - Earnings Call Transcript
2025-07-30 21:32
Financial Data and Key Metrics Changes - Glaukos reported record second quarter consolidated net sales of $124.1 million, up 30% on a reported basis or 29% on a constant currency basis compared to the same quarter last year [8] - The company raised its full year 2025 net sales guidance range to $480 million to $486 million, compared to the previous range of $475 million to $485 million [8] Business Line Data and Key Metrics Changes - The U.S. Glaucoma franchise achieved record second quarter net sales of $72.3 million, reflecting a strong year-over-year growth of 45%, driven by contributions from iDoseTR, which generated approximately $31 million in sales [10] - The international glaucoma franchise delivered record net sales of $31.3 million, with year-over-year growth of 20% on a reported basis and 15% on a constant currency basis [13] - The corneal health franchise reported net sales of $20.6 million, with a year-on-year growth of 4%, including Photrexa net sales of $17.9 million [15] Market Data and Key Metrics Changes - The U.S. market faced turbulence due to five MAC LCDs implemented in 2024, affecting the MIGS market, which is expected to continue into 2025 [11] - CMS proposed rules for 2026 largely maintained 2025 APC assignments and modestly increased facility fee rates, but proposed reductions in physician fee reimbursement for several category one CPT codes across ophthalmology [12] Company Strategy and Development Direction - The company is focused on driving new standalone intervention therapies designed to slow disease progression and reduce drug burden, particularly through the adoption of iDoseTR [9] - Glaukos plans to commence commercial launch activities for iStent Infinite in key European markets at the upcoming ESCRS Annual Meeting in September [15] - The company is advancing several important clinical programs across its five novel therapeutic platforms, including iDose and ILUTION [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the increasing clinical interest in interventional glaucoma therapies and the potential to reshape glaucoma management [10] - The transition from Photrexa to Epioxa is expected to create a material disruption headwind in Q4, as patients may defer procedures until Epioxa is available [27] - Management emphasized the importance of educating CMS on the proposed methodology shift regarding physician fees [12] Other Important Information - The company completed a small acquisition of Mobius Therapeutics, which solidifies its supply chain and supports broader glaucoma tertiary care efforts [20] - The company’s operational cash and equivalents grew by more than $4 million in the second quarter, excluding one-time investments [21] Q&A Session Summary Question: Clarification on 2025 sales guidance - Management acknowledged the exceptional second quarter performance but noted that guidance was raised conservatively due to less visibility in the second half, particularly in corneal health and U.S. glaucoma segments [24][25] Question: State of interventional glaucoma efforts - Management highlighted significant progress in building the standalone market opportunity for interventional glaucoma, with increasing traction and adoption of iDoseTR and iStent Infinite [28][30] Question: Comparison of geographic MAC coverage for iDose - Management indicated that growth was faster in MAC regions with established professional fees, and they are optimistic about progress in lagging MACs [35][36] Question: Impact of proposed reimbursement changes - Management expressed that the proposed facility fee increases are generally positive, but the overall impact on Glaukos is expected to be neutral to slightly positive [48] Question: SG&A growth expectations - Management noted a step-up in SG&A due to a one-time stock compensation expense, but overall operational expenses are expected to grow in the mid-teens [50][52] Question: iDose reimplantation decision timeline - Management clarified that the FDA has set a PDUFA date of January 28, 2026, for the iDose reimplantation petition, which reflects a change in timing [77] Question: Epioxa rollout strategy - Management indicated that the rollout of Epioxa will involve transitioning from Photrexa, with expectations of patient education and demand increasing post-approval [67][72]
Glaukos(GKOS) - 2025 Q2 - Earnings Call Transcript
2025-07-30 21:30
Financial Data and Key Metrics Changes - Glaukos reported record second quarter consolidated net sales of $124.1 million, up 30% on a reported basis or 29% on a constant currency basis compared to the same quarter last year [6] - The company raised its full year 2025 net sales guidance range to $480 million to $486 million, up from the previous range of $475 million to $485 million [6] Business Line Data and Key Metrics Changes - The U.S. Glaucoma franchise achieved record second quarter net sales of $72.3 million, reflecting a strong year-over-year growth of 45%, driven by contributions from iDoseTR, which generated approximately $31 million in sales [9] - The international glaucoma franchise delivered record net sales of $31.3 million, with year-over-year growth of 20% on a reported basis and 15% on a constant currency basis [12] - The corneal health franchise reported net sales of $20.6 million, with a year-on-year growth of 4%, including Photrexa net sales of $17.9 million [13] Market Data and Key Metrics Changes - The U.S. market faced turbulence due to five MAC LCDs implemented in 2024, affecting the MIGS market, which is expected to continue into 2025 [10] - CMS proposed rules for 2026 largely maintained 2025 APC assignments and modestly increased facility fee rates, while proposing reductions in physician fee reimbursement for several ophthalmology codes [11] Company Strategy and Development Direction - The company is focused on driving new standalone intervention therapies designed to slow disease progression and reduce drug burden [7] - Glaukos aims to maintain and grow its presence in Europe with the recent EU MDR clearance for iStent Infinite, which is indicated for all stages of open-angle glaucoma [13] - The company completed a small acquisition of Mobius Therapeutics to solidify its supply chain and support its glaucoma tertiary care efforts [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the increasing clinical interest in interventional glaucoma therapies and the potential to reshape glaucoma management [8] - The company anticipates some transient disruption in the U.S. corneal health franchise as it transitions from Photrexa to Epioxa following targeted approval [16] - Management highlighted the importance of educating CMS on proposed methodology shifts affecting reimbursement [11] Other Important Information - The company is advancing several clinical programs across its therapeutic platforms, including iDose and ILUTION, with various trials and regulatory reviews ongoing [17][18] - The company expects to launch Epioxa in 2026, which will provide a new treatment option for keratoconus patients [15] Q&A Session Summary Question: Can you discuss the components of this year's revenue guidance? - Management noted that the guidance was raised due to exceptional second quarter performance, particularly driven by iDose, with expectations for low double-digit growth in international glaucoma and flat to low single-digit growth in corneal health [22][25] Question: What is the state of interventional glaucoma and the long-term opportunity? - Management highlighted a significant shift towards interventional approaches in glaucoma care, with increasing traction for iDoseTR and iStent Infinite, indicating a bright future for the company [26][30] Question: How are professional fees impacting the legacy MIGS business? - Management discussed the relativity of professional fees and the shift towards standalone glaucoma therapy as a viable pathway for practices facing reduced cataract surgery fees [38][41] Question: What are the implications of the proposed reimbursement changes? - Management expressed that the proposed facility fee increases are generally positive, while the impact on physician fees is more neutral [46] Question: What is the expected growth for SG&A expenses? - Management indicated that total OpEx would grow in the mid-teens, with a notable one-time stock comp expense affecting the quarter's results [48][50] Question: How will the rollout of Epioxa be managed post-approval? - Management stated that the transition from Photrexa to Epioxa will impact sales, with expectations for a significant portion of patients to defer to the new treatment [66][72]
Glaukos(GKOS) - 2025 Q2 - Quarterly Results
2025-07-30 20:10
Report Overview & Conference Call Information [Important Information](index=1&type=section&id=Important%20Information) 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](index=1&type=chunk) - Refer to 'Forward-Looking Statements' and 'Statement Regarding Use of Non-GAAP Financial Measures' in the 'Additional Information' section[1](index=1&type=chunk) [Conference Call Information](index=1&type=section&id=Conference%20Call%20Information) 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](index=2&type=section&id=2.1%20Key%20Financial%20and%20Operational%20Highlights) 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](index=3&type=section&id=Global%20Consolidated%20Revenue%20Performance) 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](index=5&type=chunk) - Strong performance was primarily driven by the increasing adoption and utilization of iDose® TR and broader global Interventional Glaucoma (IG) initiatives[5](index=5&type=chunk) [Franchise Revenue Performance](index=3&type=section&id=Franchise%20Revenue%20Performance) 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](index=4&type=section&id=U.S.%20Glaucoma) 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](index=9&type=chunk) - iDose TR contributed approximately **$31.0 million** in sales during Q2[9](index=9&type=chunk) - iDose TR continues to demonstrate very positive clinical results and product feedback, with the potential to reshape glaucoma management[10](index=10&type=chunk) [International Glaucoma](index=4&type=section&id=International%20Glaucoma) 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](index=11&type=chunk) - 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](index=11&type=chunk) - Anticipate increasing headwinds in 2025 as new competitive products are trialed in key international markets[12](index=12&type=chunk) [Corneal Health](index=4&type=section&id=Corneal%20Health) 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](index=13&type=chunk) - 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](index=13&type=chunk) - The company remains focused on expanding treatment access for keratoconus patients[14](index=14&type=chunk) [Additional Commercial Updates & Commentary](index=5&type=section&id=Additional%20Commercial%20Updates%20%26%20Commentary) 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](index=15&type=chunk) - Progressing Epioxa™ FDA approval and commercial launch preparation plans[15](index=15&type=chunk) - 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](index=15&type=chunk) - 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](index=15&type=chunk) 2025 Revenue Guidance Raised to Reflect Strong Momentum [Full-Year 2025 Revenue Guidance and Influencing Factors](index=6&type=section&id=4.1%20Full-Year%202025%20Revenue%20Guidance%20and%20Influencing%20Factors) 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](index=16&type=chunk) - 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](index=16&type=chunk) Research & Development / Pipeline Overview [Pipeline Summary](index=7&type=section&id=Pipeline%20Summary) 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](index=17&type=chunk) - 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](index=19&type=chunk) [Key R&D and Pipeline Updates](index=8&type=section&id=Key%20R%26D%20and%20Pipeline%20Updates) 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](index=20&type=chunk) - The FDA has accepted the New Drug Application (NDA) for Epioxa (Epi-on), with a PDUFA date of October 20, 2025[20](index=20&type=chunk) - iStent infinite and other key trabecular micro-bypass MIGS technologies have received EU MDR certification[20](index=20&type=chunk) - 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](index=20&type=chunk) - Phase 2 clinical trial for iLution™ blepharitis is planned to commence by the end of 2025[20](index=20&type=chunk) [Product / Pipeline Chart](index=9&type=section&id=Product%20%2F%20Pipeline%20Chart) 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](index=10&type=section&id=6.1%20Non-GAAP%20Financial%20Performance%20Summary) 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](index=22&type=chunk) - Research and development expenses increased year-over-year and sequentially, reflecting continued investment and advancement in R&D programs[22](index=22&type=chunk) - 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](index=22&type=chunk) Other Important Updates [Strategic Business Developments](index=11&type=section&id=7.1%20Strategic%20Business%20Developments) 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](index=23&type=chunk) - This acquisition helps consolidate the supply chain and supports the company's broader advanced glaucoma tertiary care efforts[23](index=23&type=chunk) - Continued operational investments to support long-term growth plans by purchasing an additional building at the Aliso Viejo headquarters campus[23](index=23&type=chunk) - The company primarily manufactures and sources products in the U.S., expecting minimal direct impact from recent tariff-related policies[23](index=23&type=chunk) Additional Information & Financial Reconciliations [Forward-Looking Statements](index=13&type=section&id=Forward-Looking%20Statements) 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](index=26&type=chunk) - 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](index=26&type=chunk) - 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](index=26&type=chunk) [Statement Regarding Use of Non-GAAP Financial Measures](index=14&type=section&id=Statement%20Regarding%20Use%20of%20Non-GAAP%20Financial%20Measures) 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](index=27&type=chunk) - 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](index=27&type=chunk) - To eliminate the impact of foreign exchange rate fluctuations, the company also presents certain net sales information on a constant currency basis[28](index=28&type=chunk) [GAAP Income Statement](index=15&type=section&id=GAAP%20Income%20Statement) 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](index=16&type=section&id=GAAP%20Balance%20Sheet) 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](index=17&type=section&id=Primary%20GAAP%20to%20Non-GAAP%20Reconciliations) 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](index=33&type=chunk)[34](index=34&type=chunk) - 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](index=34&type=chunk) - Convertible senior notes related expense adjustments include **$17.4 million** in non-cash inducement expense and **$0.6 million** in direct transaction costs[34](index=34&type=chunk) 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](index=36&type=chunk)[37](index=37&type=chunk) - 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](index=37&type=chunk) [Additional GAAP to Non-GAAP Reconciliations (Constant Currency)](index=19&type=section&id=Additional%20GAAP%20to%20Non-GAAP%20Reconciliations%20(Constant%20Currency)) 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](index=40&type=chunk) - Foreign exchange impact is calculated by converting current period data using prior period average foreign exchange rates[40](index=40&type=chunk)
花旗:美国医疗科技_2025 年展望_但等等,还有更多
花旗· 2025-07-14 00:36
Investment Rating - The report maintains a "Buy" rating for Boston Scientific (BSX), Edwards Lifesciences (EW), GE Healthcare (GEHC), Intuitive Surgical (ISRG), and Haemonetics (HAE), while downgrading Tandem Diabetes (TNDM) to "Sell/High Risk" from "Neutral/High Risk" [1][5][20]. Core Insights - The MedTech sector has shown resilience against healthcare headwinds, with a focus on returning to fundamentals and several catalysts expected to drive momentum in the second half of 2025 [1][9]. - The S&P Equipment and Supplies Index has outperformed the broader market, with a year-to-date increase of 7.2%, while relative P/E multiples remain below historical averages [2][12]. - Key upcoming catalysts include product launches and data readouts from various companies, which are anticipated to influence stock performance positively [3][10][11]. Summary by Sections Market Overview - The MedTech industry has largely absorbed tariff impacts, with a weakening USD providing additional support [1][9]. - The S&P 500 is up 6.2% year-to-date, while the S&P Equipment and Supplies Index has increased by 7.2% [2][12]. Company-Specific Insights - Boston Scientific (BSX) is expected to benefit from Farapulse and new product launches, projecting a revenue increase of 80.1% year-over-year in 2Q25 [3][10]. - Edwards Lifesciences (EW) anticipates pivotal data releases and the reopening of TAVR NCD, which could enhance its market position [3][10]. - Intuitive Surgical (ISRG) plans a broad launch of its DV5 system, which is expected to drive stock performance [4][10]. - Haemonetics (HAE) has been upgraded to "Buy" due to improved guidance and revenue growth expectations [5][20]. - Tandem Diabetes (TNDM) faces competitive pressures, leading to its downgrade to "Sell/High Risk" [5][20]. Valuation and Target Prices - Target prices have been adjusted for several companies, with BSX at $125, EW at $95, GEHC at $86, and ISRG at $650 [20][21]. - The report highlights that the relative P/E multiple for the MedTech sector is currently at 1.14x, below historical averages, indicating potential undervaluation [2][12][14].
Glaukos Ramps Up iDose TR, Battles Legacy and Reimbursement Risks
ZACKS· 2025-07-09 13:20
Core Insights - Glaukos Corporation (GKOS) reported a record-breaking first-quarter 2025 performance with revenues of $106.7 million, a 25% year-over-year increase, primarily driven by the adoption of the iDose TR implant [1][8] - The company reaffirmed its full-year revenue guidance of $475-$485 million, indicating confidence in its commercial momentum [1] Near-Term Growth Drivers - The iDose TR launch is gaining traction, with U.S. glaucoma sales increasing by 41% year-over-year, contributing nearly $21 million in the first quarter, reflecting an $85 million annualized run rate [3] - Internationally, Glaukos achieved $29 million in interventional glaucoma sales, a 15% year-over-year increase, supported by the growing acceptance of minimally invasive glaucoma surgery (MIGS) [4] Long-Term Growth Catalysts - Glaukos has a robust R&D pipeline with key programs including Epioxa, iDose Trex, PRESERFLO MicroShunt, and GLK-401, which are expected to broaden the company's addressable market in the next three to five years [5][6] - The company is cultivating standalone use of MIGS devices like iStent infinite, anticipating long-term growth as more surgeons adopt interventional glaucoma practices [7] Challenges and Watchpoints - Reimbursement complexities and LCD restrictions are impacting legacy stent sales, which declined mid-single digits in the first quarter, with expectations of continued pressure through 2025 [8][9] - Sales of Photrexa remain muted due to the Medicaid Drug Rebate Program, with near-term growth in this segment expected to be flat to low-single digits [10] Competitive Landscape - The iDose TR launch positions Glaukos ahead in procedural glaucoma drug delivery, but competition from Alcon, Johnson & Johnson, and Sight Sciences remains significant [11] - Year-to-date, Glaukos shares have declined by 31.7%, underperforming its rivals in the MIGS space, while Alcon and J&J have seen increases [12]
Glaukos (GKOS) Earnings Call Presentation
2025-06-26 08:31
Investor Presentation May 2025 Disclaimer All statements other than statements of historical facts included in this presentation that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. These statements are based on management's current expectations, assumptions, estimates and beliefs. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are ba ...
What Makes Glaukos (GKOS) a New Buy Stock
ZACKS· 2025-06-16 17:01
Core Viewpoint - Glaukos (GKOS) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system reflects changes in earnings estimates, which are strongly correlated with stock price movements, particularly influenced by institutional investors [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling actions that affect stock prices [4]. Recent Performance and Outlook - Glaukos is projected to earn -$0.81 per share for the fiscal year ending December 2025, showing no year-over-year change, but the Zacks Consensus Estimate has increased by 9.3% over the past three months [8]. - The upgrade to Zacks Rank 2 places Glaukos in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10]. Zacks Rating System - The Zacks Rank system categorizes stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7][9]. - The system maintains a balanced distribution of ratings, ensuring that only the top 5% of stocks receive a "Strong Buy" rating, while the next 15% receive a "Buy" rating [9].
Can Glaukos (GKOS) Climb 34.4% to Reach the Level Wall Street Analysts Expect?
ZACKS· 2025-06-11 15:00
Core Viewpoint - Glaukos (GKOS) shows potential for significant upside, with a mean price target of $128.54 indicating a 34.4% increase from the current price of $95.64, supported by positive earnings estimate revisions [1][11]. Price Targets - The average of 13 short-term price targets ranges from a low of $72 to a high of $182, with a standard deviation of $33.39, indicating variability in analyst estimates [2]. - The lowest estimate suggests a decline of 24.7%, while the most optimistic estimate indicates a potential upside of 90.3% [2]. Analyst Consensus - Analysts have shown strong agreement in revising earnings estimates higher, which correlates with potential stock price increases [4][11]. - The Zacks Consensus Estimate for the current year has increased by 11.8%, with four estimates moving higher and no negative revisions [12]. Zacks Rank - GKOS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for upside [13]. Caution on Price Targets - Solely relying on price targets for investment decisions may be misleading, as analysts often set overly optimistic targets influenced by business relationships [3][8][10].
Glaukos (GKOS) 2025 Conference Transcript
2025-06-04 13:47
Summary of Glaukos (GKOS) 2025 Conference Call Company Overview - **Company**: Glaukos Corporation (GKOS) - **Industry**: Medical Supplies and Devices, specifically focused on glaucoma treatment Key Points and Arguments Interventional Glaucoma Paradigm Shift - The interventional glaucoma approach is gaining acceptance as a proactive method to manage glaucoma, moving away from traditional drop treatments which patients often neglect [3][4] - The company emphasizes the need for changing practice patterns and educating healthcare providers to adopt this new approach effectively [5][6] - The transition to an interventional approach is expected to take about ten years, with a focus on improving patient outcomes [6] Physician Adoption and Challenges - Physician receptiveness varies, but the main challenge lies in translating positive clinical feedback into actionable changes in practice [7][8] - The company is focused on addressing operational challenges within practices, such as educating referral networks and changing administrative processes [9] Market Dynamics and Treatment Modalities - The company acknowledges the competition from other treatment modalities like SLT and emphasizes the importance of interventional approaches in patient care [12][16] - The average patient remains in care for over 20 years, necessitating multiple interventions to manage their condition effectively [17] iDose Product Launch and Reimbursement - The iDose product has seen successful launch and is currently focused on securing reimbursement from various Medicare Administrative Contractors (MACs) [18][19] - The reimbursement landscape is segmented into three tiers, with varying levels of predictability and success in claims processing [19][20] - The company is actively working to streamline reimbursement processes and is optimistic about future growth in iDose contributions [26][27] Financial Performance and Cash Flow - The company aims to achieve cash flow breakeven in the near term, with expectations that iDose will contribute positively to gross margins over time [41][42] - Operating expenses are growing at a slower rate than revenue, indicating operational leverage is being achieved [45] Sales Strategy and Market Access - The sales force is deemed sufficient, with plans to fill geographic gaps as needed [47] - The company is focusing on supporting healthcare providers in navigating the complexities of commercial payer systems, which differ significantly from Medicare processes [36][37] Future Outlook and Growth Potential - The company anticipates continued growth in the MIGS market, with expectations of mid-single-digit growth rates in the long term [57][58] - The focus remains on increasing standalone utilization of iDose and other products, which may influence market dynamics and physician preferences [58] Additional Important Insights - The company is investing in educational initiatives and industry collaborations to promote best practices in interventional glaucoma [11] - The reimbursement process is described as a data collection effort by MACs to ensure medical necessity and appropriate payment calculations [23][24] - The company is also working on new product developments, including the Trio system, which aims to enhance in-office procedures [50][51] This summary encapsulates the key discussions and insights from the Glaukos conference call, highlighting the company's strategic focus on interventional glaucoma, product launches, and market dynamics.
Glaukos (GKOS) FY Conference Transcript
2025-06-03 18:40
Summary of Glaukos (GKOS) FY Conference June 03, 2025 Company Overview - Glaukos is focused on innovative treatments for glaucoma and other eye diseases, emphasizing dropless therapies and interventional glaucoma solutions [3][4][5] - The company has developed five novel platforms, including the iStent franchise and the latest product line, iDose [5][6] Key Products and Innovations - **iStent Franchise**: Established product line for treating glaucoma [5] - **iDose**: A new product that allows for continuous drug delivery, showing a 70% control rate of intraocular pressure over three years in trials [22][23] - **EyeLink**: A product targeting keratoconus, with an NDA submitted and a PDUFA date set for October 2025 [36] - **Ilucian**: A cream-based drug delivery system targeting Demodex blepharitis, with clinical trials starting this year [37] - **Retina Products**: Utilizing a small molecule approach for retinal diseases, with a phase one trial underway [39] Market Opportunity - The total addressable market for glaucoma treatment includes approximately 22 million eyes in the U.S., with 12 million actively treated [25] - The company aims to shift from a cataract surgery-focused market to a standalone glaucoma treatment market, which presents significant growth potential [25][26] Research and Development Investment - Over the past seven years, Glaukos has invested more than $700 million in R&D, resulting in 14 disclosed programs in the pipeline [7] - The company is committed to long-term innovation, with a focus on interventional glaucoma as a ten-year journey [28] Commercial Strategy - Emphasis on early intervention in glaucoma treatment to improve patient outcomes and reduce reliance on drops, which have low compliance rates [10][12] - The "forever patient" model allows for multiple treatment iterations over a patient's lifetime, enhancing both patient care and business opportunities for ophthalmologists [21][22] Financial Performance - Glaukos has achieved a ten-year compound annual growth rate (CAGR) of over 20% and maintains gross margins exceeding 80% [42] - The company has a strong balance sheet with over $300 million in cash and no debt [43] Future Milestones - Key milestones for 2025 include advancing clinical trials for new products and expanding market access for existing therapies [42] Conclusion - Glaukos is positioned as a leader in the ophthalmology market with a robust pipeline of innovative products aimed at improving patient care in glaucoma and other eye diseases, supported by strong financial health and a commitment to R&D [41][42]