Core Insights - Glaukos Corporation reported a narrower adjusted loss of 22 cents per share for Q1 2025, better than the Zacks Consensus Estimate of a loss of 33 cents, and improved from a loss of 70 cents per share in the same quarter last year [1] - The company achieved revenues of $106.7 million in Q1 2025, reflecting a year-over-year increase of 24.6% and surpassing the Zacks Consensus Estimate by 3.8% [2] Revenue Details - Net sales for the Glaucoma segment reached $88.1 million, marking a 31% increase year over year, while Corneal Health sales were $18.5 million [3] Margin Analysis - Gross profit rose by 25.9% year over year to $82.3 million, with an adjusted gross margin of 82%, slightly down from 83% in the previous year [4] - Selling, general and administrative expenses increased by 14% year over year to $70.7 million, while research and development expenses totaled $32.4 million, up 5.3% year over year [4] Operating Performance - The operating loss decreased to $20.7 million from $39.1 million in the prior year, with an adjusted operating loss of $15.2 million, an improvement from the loss of $32.8 million in the same quarter last year [5] Financial Update - At the end of Q1 2025, Glaukos had cash and cash equivalents and short-term investments totaling $303.4 million, down from $323.6 million at the end of Q4 2024 [6] 2025 Guidance - The company reiterated its revenue guidance for 2025, expecting net sales between $475 million and $485 million, with a consensus estimate of $480.9 million [7] Growth Drivers - The strong performance in Q1 was driven by the adoption of the iDose TR product, with the U.S. glaucoma segment experiencing a 41% year-over-year growth [9] - Management highlighted the strategic rollout of iDose TR, focusing on expanding surgeon training, payer access, and clinical validation [9] Product Development - Glaukos is advancing its product pipeline, including the FDA's acceptance of the NDA for Epioxa, targeting a PDUFA date in October 2025 [10] - The company is also progressing with the PRESERFLO MicroShunt study and other clinical trials, including the iStent infinite trial and GLK-401 for wet AMD [11] Challenges - Glaukos faces challenges from restrictive Medicare LCDs impacting the use of multiple glaucoma surgical devices, leading to a mid-single-digit decline in the U.S. stent business [12] Stock Performance - Following the Q1 results, shares of Glaukos fell by 6.6% in after-market trading, with a year-to-date decline of 37.1%, compared to the industry's decline of 9.1% [13]

Financial Performance - Net sales for the three months ended March 31, 2025, were $106.664 million, representing a 24.6% increase from $85.622 million for the same period in 2024[108]. - The net loss for Q1 2025 was $18.1 million, a 56% improvement from a net loss of $40.8 million in Q1 2024[143]. - Net sales for Q1 2025 were $106.7 million, a 25% increase from $85.6 million in Q1 2024[143]. - U.S. glaucoma product sales increased by 41% to $59.1 million in Q1 2025, up from $42.0 million in Q1 2024[145]. - International glaucoma product sales rose by 15% to $29.0 million in Q1 2025, compared to $25.2 million in Q1 2024[146]. Gross Margin and Profitability - Gross margin improved to 77% for the three months ended March 31, 2025, compared to 76% for the same period in 2024[108]. - Gross profit for Q1 2025 was $82.3 million, with a gross margin of 77%, compared to 76% in Q1 2024[148]. Operating Expenses - Operating expenses decreased to $103.026 million for the three months ended March 31, 2025, down from $104.430 million in the same period of 2024[108]. - SG&A expenses increased by 14% to $70.7 million in Q1 2025, up from $62.0 million in Q1 2024[149]. - R&D expenses rose by 5% to $32.4 million in Q1 2025, compared to $30.7 million in Q1 2024[152]. Cash Flow and Liquidity - As of March 31, 2025, the company had cash, cash equivalents, short-term investments, and restricted cash totaling $303.429 million, down from $323.648 million as of December 31, 2024[108]. - Cash and cash equivalents totaled $114.3 million as of March 31, 2025, down from $169.6 million at December 31, 2024[159]. - Operating activities used $18.5 million in net cash for Q1 2025, compared to $33.9 million in Q1 2024[168]. - For the three months ended March 31, 2025, the company reported a net cash used in operating activities of $18.5 million, a decrease from $33.9 million in the same period of 2024, reflecting improved cash flow management[169]. - The company believes that cash from operating, financing, and investing activities will be sufficient to meet its liquidity requirements for at least the next 12 months[181]. Investments and Capital Expenditures - The company purchased a 40,000 square foot building in Aliso Viejo, California, for $16.6 million, which will provide future expansion opportunities[110]. - The company plans to develop a new 200,000 square foot R&D and manufacturing facility in Huntsville, Alabama, with construction expected to begin in 2026[165]. - Capital expenditures are expected to be higher in 2025 compared to 2024 as the company upgrades manufacturing facilities and invests in R&D equipment[175]. Challenges and Market Conditions - The annual growth rate of net sales for the international glaucoma business was negatively impacted by approximately 380 basis points for the three months ended March 31, 2025, primarily due to the Euro[113]. - The company anticipates ongoing supply chain challenges and higher costs for certain components and raw materials throughout 2025[112]. Product Utilization and Reimbursement - The establishment of reimbursement for the iDose TR procedure is expected to increase utilization as the process becomes more timely and consistent[120]. - Approximately 80% of procedures utilizing the iStent family of products in the U.S. are performed in the Ambulatory Surgery Center (ASC) setting[119].

Financial Data and Key Metrics Changes - Glycos Corporation reported record first quarter consolidated net sales of $106.7 million, up 25% on a reported basis and 26% on a constant currency basis compared to the same quarter last year [9] - The company reaffirmed its full year 2025 net sales guidance range of $475 million to $485 million [9] Business Line Data and Key Metrics Changes - The U.S. Glaucoma franchise achieved record first quarter net sales of $59.1 million, reflecting a year-over-year growth of 41%, driven by the adoption of iDoseTR [11] - The interventional glaucoma franchise delivered record net sales of $29 million, with a year-over-year growth of 15% on a reported basis and 19% on a constant currency basis [13] - The corneal health franchise reported net sales of $18.5 million, including $15.4 million from Vetrexa, impacted by the company's entry into the Medicare drug rebate program [15] Market Data and Key Metrics Changes - The U.S. glaucoma business experienced over 40% year-over-year growth and a 5% sequential growth in the first quarter [24] - International glaucoma sales showed strong growth, with expectations of high single-digit to low double-digit growth year-over-year [35] Company Strategy and Development Direction - The company is focused on pioneering the Interventional Glaucoma marketplace with new therapies aimed at slowing disease progression and reducing drug burden [10] - Glycos is actively expanding its global infrastructure and market access for its interventional glaucoma products, anticipating new product approvals in the coming years [13][14] - The company is also preparing for the commercial launch of Epioxa, a next-generation corneal cross-linking therapy, with an FDA review expected by October 20, 2025 [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong foundation built for iDoseTR and the transformative potential of this technology in glaucoma management [12] - The company acknowledged potential headwinds from new competitive products in major international markets as it progresses through 2025 [14] - Management emphasized the importance of navigating macroeconomic uncertainties while maintaining a strong capital position with over $3 billion in cash and no debt [18] Other Important Information - The company is actively pursuing collaborations to enhance its capabilities in glaucoma diagnosis and care networks [19] - Glycos expects minimal direct exposure to recent tariff-related policies due to its primary manufacturing and sourcing within the United States [19] Q&A Session Summary Question: Can you provide U.S. spend growth in the quarter? - The U.S. glaucoma business reported over 40% year-over-year growth and a 5% sequential growth, driven by iDoseTR adoption, despite some impact from LCD restrictions [24] Question: Have you seen any acceleration in reimbursement in the Noridian region? - Noridian has shown solid and expanding growth, serving as a case study for other MACs as they come online [29] Question: What are the components of guidance for the remainder of the year? - The guidance remains unchanged, with expectations for flat to low single-digit growth in the corneal health business and mid single-digit declines for non-iDose revenues in 2025 [35][36] Question: How exposed is the company to an economic slowdown? - The company believes ophthalmology is somewhat insulated from economic downturns, but acknowledges potential impacts on surgery centers and customer offices [52] Question: What is the status of iDose reimplantation with the FDA? - The post-approval NDA supplement for iDose has been submitted to the FDA, with results expected by year-end [65] Question: How broad is the commercial coverage for iDose? - Coverage policies extend over more than 50% of the potential patient population, with early successes in claims processing with major payers [58] Question: What is the expectation for operational expenses growth? - The company continues to expect about 15% year-over-year growth in operational expenses off the adjusted 2024 base [93]

Financial Data and Key Metrics Changes - Glycos Corporation reported record first quarter consolidated net sales of $106.7 million, up 25% on a reported basis and 26% on a constant currency basis compared to the same quarter last year [7] - The company reaffirmed its full year 2025 net sales guidance range of $475 million to $485 million [7] Business Line Data and Key Metrics Changes - The U.S. glaucoma franchise achieved record first quarter net sales of $59.1 million, reflecting a strong year-over-year growth of 41%, primarily driven by the adoption of iDoseTR [10] - The interventional glaucoma franchise delivered record net sales of $29 million, with a year-over-year growth of 15% on a reported basis and 19% on a constant currency basis [12] - The corneal health franchise reported net sales of $18.5 million, including Vetrexa net sales of $15.4 million, impacted by the company's entry into the Medicare drug rebate program [13] Market Data and Key Metrics Changes - The U.S. glaucoma business experienced over 40% year-over-year growth and 5% sequential growth, driven by iDoseTR expansion, despite some decline in the stent franchise due to LCD restrictions [20] - International glaucoma sales showed strong growth as the company continues to scale its infrastructure and drive MIGS forward as the standard of care [12] Company Strategy and Development Direction - The company is focused on pioneering the Interventional Glaucoma marketplace with new therapies aimed at slowing disease progression and reducing drug burden [9] - Glycos is actively working on expanding its product portfolio and market access globally, anticipating new product approvals in the coming years [12][14] - The company has a strong capital position with cash and equivalents exceeding $3 million and no debt, allowing for continued investment in growth initiatives [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong foundation built for iDoseTR and the transformative potential of this technology in glaucoma management [11] - The company acknowledged potential headwinds from competitive products and macroeconomic uncertainties but remains committed to its growth trajectory [12][33] - Management emphasized the importance of generating clinical evidence to support the use of combination therapies in glaucoma treatment [76] Other Important Information - The FDA accepted the NDA for Epioxa, a next-generation corneal cross-linking therapy, with a PDUFA date set for October 20, 2025 [14] - The company is also advancing several clinical trials, including pivotal studies for various therapies aimed at treating glaucoma and other eye diseases [15] Q&A Session Summary Question: Can you provide U.S. spend growth in the quarter? - The U.S. glaucoma business reported over 40% year-over-year growth and a 5% sequential growth, driven by iDoseTR, despite a mid-single-digit decline in the stent franchise due to LCD restrictions [20] Question: How is the reimbursement situation for iDose in the Noridian region? - Noridian has shown solid growth, and while some customers are achieving high volumes, others are still in the early adoption phase [95] Question: What are the expectations for iDose revenue growth? - The company expects continued progress in iDose revenue, with a modest increase in expectations for the remainder of 2025 [34] Question: How is the company addressing the impact of LCD restrictions? - The company is navigating the impact of LCD restrictions and expects to see a mid-single-digit decline in non-iDose revenues in 2025 [33] Question: What is the company's strategy regarding commercial coverage? - The company is methodically rolling out access to commercial Medicare Advantage and expects to see coverage policies extend over more than 50% of the potential patient population [56] Question: What are the expectations for operational expenses? - The company continues to expect about 15% year-over-year growth in operational expenses off the adjusted 2024 base [91]

APRIL 30, 2025 GLAUKOS CORPORATION (NYSE: GKOS) FIRST QUARTER 2025 IN REVIEW Important Information This document is intended to be read by investors in advance of regularly scheduled quarterly conference calls and was designed to provide a review of Glaukos Corporation's recent financial and operational performance and general business outlook. Please see "Forward-Looking Statements" and "Statement Regarding Use of Non-GAAP Financial Measures" in the "Additional Information" section of this document. | Conf ...

Glaukos Corporation (GKOS) reported record fourth-quarter 2024 revenues of $105.5 million, reflecting a 28% year-over-year increase. This growth was driven by strong demand for its innovative glaucoma and corneal health solutions. The company’s success in expanding its iDose TR adoption and international footprint further bolstered its financial performance. As GKOS continues to expand its footprint in the ophthalmology sector, key elements should shape its trajectory this year.The increasing prevalence of ...

Financial Performance - Net sales for 2024 reached $383.481 million, a 21.9% increase from $314.711 million in 2023[354]. - Gross profit for 2024 was $289.454 million, up from $239.136 million in 2023, reflecting a gross margin improvement[354]. - Total operating expenses increased to $411.820 million in 2024, compared to $367.836 million in 2023, primarily driven by higher selling, general and administrative expenses[354]. - The net loss for 2024 was $146.372 million, slightly higher than the net loss of $134.661 million in 2023[354]. - Cash and cash equivalents increased to $169.626 million in 2024, up from $93.467 million in 2023, indicating improved liquidity[353]. - Total assets grew to $974.756 million in 2024, compared to $940.414 million in 2023, reflecting a strong balance sheet[353]. - Stockholders' equity increased significantly to $766.931 million in 2024, up from $461.766 million in 2023, driven by additional paid-in capital[353]. - The company reported a net operating loss (NOL) of $147.8 million for the year ended December 31, 2024, compared to $138.2 million in 2023 and $101.3 million in 2022[512]. Revenue and Sales - The company’s revenue is derived from product sales in the U.S. and internationally, with revenue adjustments for volume-based rebates and other incentives[348]. - Total revenue for glaucoma products increased from $237.0 million in 2023 to $303.3 million in 2024, representing a growth of 27.9%[464]. - The company has faced challenges in auditing net sales, particularly in evaluating discounts and incentives related to customer programs[350]. Cash and Liquidity - The company has significant amounts of cash and cash equivalents at U.S. financial institutions that exceed federally insured limits, posing credit risk[337]. - Cash, cash equivalents, and restricted cash at the end of the period increased to $174.4 million from $99.3 million at the beginning of the period[362]. - The company maintains cash balances exceeding federally insured amounts, indicating a strong liquidity position[376]. Expenses and Costs - Research and development expenses were $136.425 million in 2024, slightly down from $138.768 million in 2023, indicating a focus on cost management[354]. - The company recorded advertising costs of approximately $3.6 million, $3.4 million, and $2.5 million for the years ended December 31, 2024, 2023, and 2022, respectively[413]. - Depreciation and amortization expense related to property and equipment rose to $10.1 million in 2024, up from $7.3 million in 2023, marking an increase of approximately 38.4%[438]. Risks and Challenges - The company reported a significant risk related to the commercial success of its iDose TR product, which could materially impact its business[19]. - The company faces potential supply and manufacturing disruptions that could reduce gross margins and negatively affect operating results[19]. - The company has not yet achieved sustained profitability and may fail to generate sufficient sales of its commercialized products[19]. - The company is exposed to foreign currency exchange risks, particularly as international operations grow, which could increase operational costs[338]. Foreign Currency and Hedging - A hypothetical 10% fluctuation in foreign exchange rates would have an immaterial impact on the company's net loss as of December 31, 2024[340]. - The company has not entered into foreign currency hedging contracts but may consider doing so in the future[339]. Stock and Equity - The weighted-average shares outstanding used to compute basic and diluted net loss per share increased to 52.755 million in 2024 from 48.433 million in 2023[354]. - The company has 5,000,000 authorized preferred stock issuable, with no preferred stock outstanding as of December 31, 2024, and December 31, 2023[428]. - The total stock-based compensation cost for the year ended December 31, 2024, was $50.2 million, an increase of 15.4% from $43.5 million in 2023[510]. Tax and Deferred Assets - Deferred tax assets increased to $269.6 million as of December 31, 2024, from $224.0 million in 2023, primarily due to an increase in net operating loss carryforwards[513]. - The valuation allowance for deferred tax assets increased by $50.7 million in 2024, indicating management's expectation that a portion of these assets may not be realized[514]. - The company had approximately $527.5 million in federal NOL carryforwards as of December 31, 2024, with $322.8 million subject to an 80% limitation on future taxable income[515]. Acquisitions and Investments - The company acquired a clinical stage biopharma company for $5.0 million in stock and $5.1 million in cash, with potential future payments of up to $201.0 million based on development and sales milestones[370]. - The company’s investment portfolio is primarily in marketable securities, with all investments stated at fair value[377]. Lease and Liabilities - Operating lease liabilities increased from $30.4 million in 2023 to $33.9 million in 2024, an increase of approximately 11.5%[455]. - The total lease liabilities rose from $103.2 million in 2023 to $105.9 million in 2024, indicating an increase of approximately 2.6%[455]. - The contingent consideration liability increased from $1.4 million to $1.6 million during 2024, reflecting a change in fair value due to updated assumptions[447].

Core Insights - Glaukos Corporation received FDA notification for the New Drug Application (NDA) of Epioxa, a next-gen corneal cross-linking therapy for keratoconus, allowing for substantive review [1] - The FDA's review completion goal date for Epioxa is set for October 20, 2025 [1] - The acceptance of the NDA is a significant step towards providing the first FDA-approved, non-invasive corneal cross-linking drug therapy for keratoconus patients [2] Clinical Data - The NDA submission includes data from two Phase 3 pivotal trials that met primary efficacy endpoints and showed favorable safety and tolerability profiles [3] - Epioxa employs a proprietary drug formulation designed to penetrate the corneal epithelial layer, along with a stronger UV-A irradiation protocol and supplemental oxygen to enhance cross-linking [4] Market Reaction - Following the news, Glaukos' stock price increased by 25%, reaching $157.36 in premarket trading [4]

Core Insights - Glaukos Corporation reported a narrower adjusted loss of 40 cents per share for Q4 2024, better than the Zacks Consensus Estimate of a 43 cents loss and improved from a 63 cents loss in the same quarter last year [1] - The company achieved revenues of $105.5 million in Q4 2024, reflecting a 28.1% year-over-year increase and surpassing the Zacks Consensus Estimate by 4.7% [2] Revenue Details - Net sales for Glaucoma reached $84.1 million, marking a 39% year-over-year increase, while sales in Corneal Health remained stable [3] Margin Analysis - Gross profit rose by 21.1% year-over-year to $76.9 million, with an adjusted gross margin of 82%, down from 84% in the previous year [4] - Selling, general, and administrative expenses increased by 9.5% year-over-year to $69 million, while research and development expenses decreased by 1.4% to $36.5 million [4] Financial Update - Glaukos ended Q4 2024 with cash and cash equivalents and short-term investments totaling $324 million, up from $267.2 million at the end of Q3 2024 [6] 2025 Guidance - The company expects 2025 revenues to be between $475 million and $485 million, significantly higher than the previous guidance of $370 million to $376 million, with a loss per share estimate of $1.08, indicating a 42.8% improvement year-over-year [7] Operational Highlights - The glaucoma franchise's revenue growth was driven by the iStent portfolio and increasing contributions from iDose TR, with plans to enhance market access for iDose TR in 2025 [9] - Glaukos is advancing its product pipeline, including an NDA submission for Epioxa, with expected approval by the end of 2025, and is conducting a phase 2b/3 clinical trial for iDose TREX [10][11] Market Performance - Following the Q4 results, shares of Glaukos fell by 13.6% in after-market trading, although the stock has gained 6.1% year-to-date, contrasting with a 0.1% decline in the industry [12]

Financial Data and Key Metrics Changes - Glaukos reported record fourth quarter consolidated net sales of $105.5 million, up 28% year-over-year [9] - For the full year 2024, consolidated net sales reached $383.5 million, growing 22% compared to 2023 [10] - The company provided full-year 2025 net sales guidance in the range of $475 million to $485 million [10] Business Line Data and Key Metrics Changes - U.S. glaucoma franchise achieved record fourth quarter net sales of $56.3 million, reflecting a strong year-over-year growth of 45%, primarily driven by iDose TR [13] - International glaucoma franchise delivered record net sales of $27.9 million, with year-over-year growth of 28% on a reported basis and 29% on a constant currency basis [21] - Corneal health franchise reported net sales of $21.4 million, including Photrexa net sales of $18.8 million, benefiting from entry into the Medicaid Drug Rebate Program [23] Market Data and Key Metrics Changes - The U.S. market for glaucoma procedures includes over 20 million eyes with ocular hypertension or glaucoma, with approximately 10 million actively treated [55] - The international growth outlook for 2025 is expected to be high single-digit growth, impacted by foreign exchange headwinds and competitive product trials [82][84] Company Strategy and Development Direction - Glaukos aims to pioneer new marketplaces within ophthalmology, focusing on interventional glaucoma and innovative treatment options [11] - The company is expanding its clinical literature and training programs to support the adoption of iDose TR and enhance market access [14][15] - Plans to build a new research, development, and manufacturing facility in Huntsville, Alabama, to support future expansion [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of iDose TR, with expectations for increasing adoption as reimbursement confidence improves [39] - The company anticipates that the headwinds from new LCD restrictions will peak in the first half of 2025, with a gradual improvement expected in the second half [51] - Management remains optimistic about the potential of Epioxa, a next-generation corneal cross-linking therapy, with an anticipated FDA approval decision by the end of 2025 [25][27] Other Important Information - The company ended 2024 with cash and equivalents of approximately $324 million and no debt, following the retirement of $287.5 million in convertible senior notes [30] - Glaukos is advancing a Phase 2 clinical program for its third-generation iLink therapy and plans to commence a Phase 2 trial for iLution Blepharitis in 2025 [28] Q&A Session Summary Question: Can you elaborate on the trends seen with iDose in the quarter? - Management noted strong performance with iDose TR revenues doubling compared to the previous quarter, supported by positive clinical outcomes and expanding surgeon training [35][36] Question: Can you break down the components of the 2025 revenue guidance? - Management indicated that the guidance reflects healthy expectations for the iDose franchise, while non-iDose revenues may see flat to low single-digit growth due to LCD headwinds and the expiration of the Hydrus royalty [41][42] Question: How do you expect the impact of LCD headwinds to play out in 2025? - Management expects the headwinds to peak in the first half of the year, with some improvement anticipated in the second half [51][52] Question: What is the status of iDose's market share compared to DURYSTA? - Management characterized the growth as overall market expansion rather than direct share gains from DURYSTA, emphasizing the opportunity for multiple products to grow together [58][59] Question: What is the expected timeline for iDose TRIO? - Management expects to begin a small safety study for iDose TRIO mid-year, with a commercial launch anticipated in 2026 [92] Question: How is the uptake of iDose varying between larger and smaller facilities? - Management noted that smaller facilities tend to adopt iDose more readily, while larger systems face more bureaucratic hurdles [122]