Glaukos (NYSE:GKOS) FY Conference November 18, 2025 11:00 AM ET Company ParticipantsChris Lewis - VP of Investor RelationsAlex Thurman - CFOConference Call ParticipantsMason Carrico - AnalystMason CarricoYou guys good to go?Yeah.All right. Welcome to day one of the Stephens Conference. I'm Mason Carrico. I'm the diagnostics and medtech analyst here. Excited to have the Glaukos team with us. Here today, we've got Alex Thurman, CFO, and Chris Lewis, IR. Appreciate you guys joining us this morning.Alex Thurman ...

Summary of Glaukos Conference Call Company Overview - **Company**: Glaukos Corporation - **Products Discussed**: Epioxa and iDose - **Industry**: MedTech, specifically focused on ophthalmic therapies Key Points Epioxa Pricing and Market Dynamics - Epioxa pricing was established after extensive research and consideration of value for patients, providers, and the payer system [5][6] - The company aims to maximize patient awareness and provider education, which is costly but essential for accessing therapies [7][8] - There are approximately 5 million cataract procedures annually in the U.S., but only about 10,000 patients are currently treated with FOTREXA, indicating a significant opportunity for Epioxa [6][9] - The gross-to-net dynamics for Epioxa include: - A 23% statutory discount for Medicaid patients [11] - A similar discount for sales to 340B public hospital systems [11] - Coverage of out-of-pocket costs for commercial patients to ensure access [12][13] Physician Reactions and Market Access - Initial physician feedback on Epioxa pricing has been mixed, with some expressing shock and unrest [15] - The company emphasizes that pricing decisions were made with patient access as a priority, and they are prepared to engage with physicians to explain their rationale [15][16] - The reimbursement landscape for Epioxa is expected to be non-linear, differing from the iDose experience due to the patient demographics and the number of insurance plans involved [19][20] Patient Volume and Market Potential - The U.S. market for Epioxa is estimated to have around 10,000 patients, with potential to reach 20,000 eyes at peak [23] - The company believes there are significantly more undiagnosed patients with keratoconus, indicating a larger market opportunity [25][26] - The goal is to not only return to previous treatment levels but to expand significantly beyond that [25][26] Comparison with iDose - The peak sales opportunity for iDose is viewed as larger than Epioxa due to a larger patient population (21 million potential ocular hypertensive and glaucomatous eyes) [27][28] - iDose is expected to benefit from a more established market and clearer treatment guidelines compared to Epioxa, which is in a rare disease category [21][22] Reimbursement and Market Access Challenges - The company is confident in the long-term access for iDose despite potential hurdles from the CAC (Coverage Advisory Committee) discussions [29][30] - The reimbursement process is complex, with a need for extensive data to support market access [30][31] - The company is optimistic about the potential for Medicare Advantage plans to cover iDose, which could expand access significantly [34][36] Future Outlook - The company is focused on driving incremental utilization in both commercial and Medicare Advantage populations [56][57] - There is a belief that the dynamics of patient access will improve over time as the company continues to engage with payers and physicians [35][36] Additional Insights - The company acknowledges the challenges of competing for operating room time during peak cataract surgery seasons, which may impact iDose sales [44][45] - The management is cautious about setting revenue expectations, considering various scenarios for both Epioxa and iDose [50][52] This summary encapsulates the key discussions and insights from the Glaukos conference call, highlighting the company's strategic focus on pricing, market access, and future growth opportunities in the ophthalmic therapy space.

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Summary of Glaukos Conference Call Company Overview - **Company**: Glaukos Corporation - **Industry**: Medical Technology (MedTech), specifically focused on ophthalmology and glaucoma treatment Key Financial Highlights - **Q3 Results**: Achieved record glaucoma revenues and total revenues, reporting $40 million from iDose for the quarter, a sequential increase from Q2 [7][40] - **Guidance Update**: Raised annual revenue guidance from $490 million to $495 million, indicating strong business growth as the year closes [7][40] Product Insights iDose - **Market Potential**: iDose is positioned to expand the total addressable market (TAM) for glaucoma treatments, with an estimated 22 million eyes affected by ocular hypertension and glaucoma, of which 12 million are currently treated [44][45] - **Clinical Evidence**: iDose has undergone two phase 3 trials with over 1,150 patients, demonstrating efficacy and safety [20][21] - **Future Growth**: Expected to exit 2025 with a run rate of approximately $180 million, with projections for 2026 around $220 million [42][40] EPIAXA - **New Approval**: EPIAXA is a new treatment for keratoconus that does not require corneal debridement, improving patient experience [115][121] - **Market Opportunity**: Currently, only 10,000 patients are treated annually, but there is potential for 50,000 patients who are not receiving treatment [117][119] - **Investment Focus**: Significant investments will be made to educate and identify patients, with a focus on establishing market access and reimbursement [123][129] Market Dynamics - **Interventional Glaucoma (IG)**: The company is focused on promoting interventional glaucoma treatments, which aim to address noncompliance with topical medications [49][78] - **Surgeon Adoption**: The adoption of IG practices is still in early stages, with a need for education and support for surgeons to implement these treatments effectively [186][190] Regulatory and Reimbursement Landscape - **MACs and J Code**: All seven Medicare Administrative Contractors (MACs) are now paying for the J code, with ongoing efforts to establish pro fees for remaining MACs [93][100] - **Future Reimbursement**: The establishment of a J code is expected to enhance commercial plan adoption and streamline reimbursement processes [135][139] R&D and Innovation - **Pipeline Development**: Glaukos has 14 publicly disclosed pipeline programs, including next-generation iDose and iLution for blepharitis [167][169] - **Focus on Innovation**: The company aims to build a world-class ophthalmology company through continuous innovation and product development [166][167] International Market Outlook - **Growth Drivers**: The approval of iStent infinite in Europe is expected to drive growth, with strong demand observed at recent conferences [193][195] - **Market Access Challenges**: Each international market presents unique challenges, but there is significant room for growth in unlocking potential [203][205] Conclusion - **Strategic Focus**: Glaukos is committed to addressing unmet patient needs through innovative products and expanding market access, with a clear path towards profitability and growth in the interventional glaucoma market [209][210]

Core Insights - Brown Capital Management sold 376,359 shares of Glaukos Corporation for an estimated $34.6 million in Q3, reducing its holding to 762,760 shares valued at $62.2 million [2][3] - The sale decreased Glaukos Corporation's weight in Brown Capital Management's portfolio to 2.6% of 13F assets [3][6] - Glaukos shares have declined approximately 34% over the past year, significantly underperforming the S&P 500, which is up nearly 15% [3] Company Overview - Glaukos Corporation specializes in ophthalmic medical technology, focusing on innovative micro-scale devices and pharmaceutical solutions for glaucoma and related eye disorders [5] - The company reported a total revenue of $433 million and a net income loss of $92.8 million for the trailing twelve months (TTM) [4] - As of the latest market close, Glaukos's stock price was $84.35, with a market capitalization of $4.8 billion [4] Recent Performance - The company's revenue grew by 28% year-over-year to $105.5 million, but it faced larger-than-expected losses and rising expenses, leading to a decline in stock price [7] - Management anticipates sales between $475 million and $485 million for 2025, while acknowledging challenges related to currency exchange and market entry [8] Strategic Positioning - Glaukos aims to expand its product portfolio and leverage proprietary technology platforms to meet unmet clinical needs in ophthalmology [5] - The company's competitive advantage lies in its focus on minimally invasive therapies and a robust pipeline targeting multiple ophthalmic indications [5][8]

Core Insights - Xencor is advancing its clinical trial programs with two first-in-class bispecific antibodies, XmAb819 and XmAb541, targeting specific cancer types, showing promising initial results [1][7] - The company reported significant revenue growth in Q2 2025, primarily from milestone payments and royalties, indicating a strong financial position despite not having marketed drugs [2] - Xencor has a diverse pipeline with over a dozen drug candidates at various development stages, showcasing its robust research capabilities [3][4] Group 1: Clinical Development - XmAb819 targets clear cell renal cell carcinoma (ccRCC) and has shown a 25% overall response rate in heavily pretreated patients during Phase 1 trials [1] - XmAb541 is under evaluation for advanced solid tumors expressing CLDN6, with ongoing Phase 1 dose escalation studies [7] - The company plans to recommend a Phase 3 dose for XmAb819 next year and initiate pivotal studies by 2027 [1] Group 2: Financial Performance - Xencor's Q2 2025 revenue reached $43.6 million, an 82% increase compared to Q2 2024, driven by milestone payments and non-cash royalties [2] - The company does not market any approved drugs directly but benefits from royalties on licensed products [2] Group 3: Analyst Sentiment - Despite a 39% decline in stock price year-to-date, analysts like Barclays's Etzer Darout have upgraded Xencor to Overweight, citing positive updates on its pipeline [8][9] - The consensus rating for Xencor stock is Strong Buy, with 12 Buy ratings and a price target suggesting an 85% potential gain over the next 12 months [11]

Core Insights - Glaukos (NYSE: GKOS) experienced a significant stock increase of nearly 14% following a strong quarterly earnings report, contrasting with a 1% decline in the S&P 500 [1] Group 1: Sales Performance - Glaukos achieved record net sales of $133.5 million in the third quarter, representing a 38% year-over-year growth, driven primarily by glaucoma treatment sales, which reached $110 million, a 45% increase compared to the same period in 2024 [2] - Analysts had anticipated third-quarter revenue to be just under $122.5 million, with a projected non-GAAP net loss of $0.26 per share, while the actual non-GAAP net loss was $9.2 million, or $0.16 per share, significantly better than the previous year's loss of over $15 million [3] Group 2: Future Guidance - Based on the current momentum, Glaukos management raised its full-year 2025 net sales guidance to a range of $490 million to $495 million, up from the previous estimate of $480 million to $486 million [4] - Preliminary guidance for full-year 2026 net sales is projected to be between $600 million and $620 million [5]

Financial Performance - Net sales for the three months ended September 30, 2025, were $133.5 million, a 38.1% increase from $96.7 million in the same period of 2024[123] - Gross margin for the three months ended September 30, 2025, was 78%, compared to 77% for the same period in 2024[123] - The company incurred net losses of $16.2 million and $54.0 million for the three and nine months ended September 30, 2025, respectively, compared to net losses of $21.4 million and $112.8 million for the same periods in 2024[123] - Net sales for the nine months ended September 30, 2025, were $364.3 million, a 31% increase from $278.0 million in the same period of 2024[182] - U.S. net sales of glaucoma products increased by 48% to $212.2 million, driven by higher volumes of iDose TR[183] - International sales of glaucoma products rose by 18% to $89.7 million, with significant growth in key markets like France, Japan, and the UK[184] - Gross profit for the nine months ended September 30, 2025, was $284.3 million, reflecting a gross margin of 78%, up from 76% in 2024[186] Expenses - SG&A expenses increased by 30% to $83.0 million for the three months ended September 30, 2025, up from $64.0 million in 2024[173] - R&D expenses rose by 10% to $38.1 million for the three months ended September 30, 2025, compared to $34.7 million in 2024[177] - Selling, general and administrative (SG&A) expenses increased by 23% to $237.0 million, with $17.1 million attributed to increased compensation and related employee costs[189] - Research and development (R&D) expenses totaled $107.0 million, with $75.6 million in core R&D and $31.4 million in clinical expenses[191] Cash Flow and Investments - Cash and cash equivalents as of September 30, 2025, totaled approximately $98.2 million, with short-term investments at $175.5 million[198] - Operating activities used $21.6 million in net cash for the nine months ended September 30, 2025, a significant improvement from $61.8 million used in the same period of 2024[207] - The company plans to invest over $80.0 million in a new 200,000 square foot R&D and manufacturing facility in Huntsville, Alabama, with construction expected to begin in 2026[204] - For the nine months ended September 30, 2025, the company received $18.2 million from stock options and employee stock purchases[216] - For the nine months ended September 30, 2024, the company received $36.9 million from stock options and employee stock purchases[217] Market Developments - The company received FDA approval for Epioxa on October 20, 2025, which is the first incision-free topical drug therapy for keratoconus, with plans to commercialize in Q1 2026[125] - The approval of Epioxa is anticipated to disrupt the U.S. Corneal Health franchise as the market transitions from Photrexa to Epioxa[145] - The establishment of reimbursement for the iDose TR procedure is expected to increase utilization as it becomes more consistent across all MACs[142] - The international glaucoma business saw a positive impact of approximately 330 basis points on net sales growth for the three months ended September 30, 2025, primarily due to currency fluctuations[133] Challenges - The company experienced higher costs for certain components and raw materials due to ongoing supply chain challenges and inflationary pressures[129] - Non-operating income decreased to $0.4 million for the three months ended September 30, 2025, from $3.4 million in 2024, primarily due to changes in unrealized foreign currency amounts[179] - There have been no significant changes to material cash requirements as of September 30, 2025, compared to the previous disclosures[219] - There have been no material changes in exposure to market risk since December 31, 2024[225]

Core Insights - Glaukos Corporation reported a narrower adjusted loss of 16 cents per share for Q3 2025, better than the Zacks Consensus Estimate of a 27-cent loss and improved from a 28-cent loss in the same quarter last year [1] - The company achieved revenues of $133.5 million, reflecting a 38% year-over-year increase and surpassing the Zacks Consensus Estimate by 9.5% [2] Revenue Details - Net sales for Glaucoma reached $110.2 million, up 45% year over year, while Corneal Health sales totaled $23.3 million [3] Margin Analysis - Gross profit increased by 41.3% year over year to $104.7 million, with an adjusted gross margin of 84%, up from 82% in the previous year [4] - Selling, general, and administrative expenses rose by 30% year over year to $83 million, while research and development expenses increased by 10% to $38.1 million [4] Operating Performance - The operating loss decreased to $16.4 million from $24.7 million in the prior year, with an adjusted operating loss of $9.3 million, an improvement from the $18.4 million loss in the same quarter last year [5] Financial Update - At the end of Q3 2025, Glaukos had cash and cash equivalents and short-term investments totaling $277.5 million, slightly down from $278.6 million at the end of Q2 2025 [6] 2025 Guidance - The company raised its 2025 revenue guidance to a range of $490-$495 million, up from the previous estimate of $480-$486 million, with a loss per share estimate of 90 cents, indicating a 51.6% year-over-year improvement [7] Strategic Developments - The FDA approval of Epioxa represents a significant advancement, introducing a next-generation, incision-free therapy for keratoconus, enhancing Glaukos' rare disease portfolio [10] - The company is focused on disciplined capital allocation, robust R&D investment, and the upcoming Huntsville facility to support innovation and manufacturing scale, positioning itself for sustainable growth [11]

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