Financial Data and Key Metrics Changes - The company has transitioned from a cash-burning phase to a cash flow break-even profile, with the convertible debt retired and a focus on capital-light operations [31][32] - Revenue growth is expected to continue, with operating margins projected in the 30% to 35% range as the company progresses towards profitability [76][77] Business Line Data and Key Metrics Changes - The core MIGS market has seen double-digit growth over the past year but is projected to decline in the mid-single digits next year, with the stent business expected to stabilize [13][16] - iDose is becoming a significant driver of revenue, with a shift towards pharmaceutical revenue potentially surpassing device revenue [9][10] Market Data and Key Metrics Changes - The reimbursement landscape for concomitant MIGS is facing low double-digit decreases, impacting professional fees while facility economics remain stable [20] - The company is currently working with four of the seven MACs that are reimbursing for professional fees, representing about 70% of Medicare lives [44] Company Strategy and Development Direction - The company aims to establish itself in the interventional glaucoma market, focusing on innovative product solutions and expanding its pipeline to include rare disease treatments like Epioxa [9][62] - The strategy includes enhancing education and awareness for rare diseases, which requires a different approach compared to more prevalent conditions like glaucoma [60][62] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the importance of clinical outcomes and physician enthusiasm for iDose, which is expected to drive growth [28][30] - The company is focused on executing its strategies and addressing reimbursement challenges to facilitate broader adoption of its products [84][85] Other Important Information - The next-generation iDose TREX is in development, designed to carry a larger drug payload and potentially allow for longer durations of effect [55][56] - The company is also exploring in-office procedures for iDose, which could expand its market reach [57] Q&A Session Summary Question: What are the expectations for the iDose launch? - Management noted that while there were initial challenges with reimbursement, the clinical performance of iDose has exceeded expectations, leading to increased physician interest [26][28] Question: How is the company approaching profitability? - The focus remains on achieving cash flow breakeven in the short term while balancing revenue growth with necessary investments in product launches and R&D [75] Question: What is the outlook for the reimbursement landscape? - Management indicated that continued education and clinical demand are essential for expanding reimbursement coverage, with a goal of reducing the focus on reimbursement issues over time [49][50]

Financial Data and Key Metrics Changes - The company has transitioned from a cash-burning phase to a cash flow break-even profile, with the convertible debt retired and a return to normal capital spending [31][32] - Operating expenses are growing, but the company is showing leverage in its financial model as revenues increase [32][33] Business Line Data and Key Metrics Changes - The core MIGS market has seen double-digit growth over the past year but is projected to decline in the mid-single digits next year [13][16] - The introduction of iDose is cannibalizing some of the stent business, but it is also expanding the overall market opportunity [15][19] Market Data and Key Metrics Changes - The reimbursement landscape for concomitant MIGS is expected to decline in low double digits for 2026, impacting professional fees [20] - Four out of seven MACs are now reimbursing for the professional fee associated with iDose, covering about 70% of Medicare lives [44] Company Strategy and Development Direction - The company is focused on creating differentiated product solutions in large market opportunities, with a shift towards pharmaceutical revenues [9][10] - The strategy includes a strong emphasis on education and awareness for rare diseases, particularly with the launch of Epioxa [62] Management's Comments on Operating Environment and Future Outlook - Management is optimistic about the future, citing strong physician enthusiasm and positive clinical outcomes for iDose [28][30] - The company aims to shift discussions from reimbursement issues to clinical adoption and standard of care improvements in the coming year [84] Other Important Information - The next-generation iDose TREX is in development, designed to carry a larger drug payload and potentially allow for longer duration effects [55][56] - The company recognizes the challenges in treating rare diseases and is committed to transforming its approach to market access and patient education [60][62] Q&A Session Summary Question: What are the expectations for the MIGS market? - The MIGS market has grown but is expected to stabilize next year, with iDose impacting the stent business [15][16] Question: How is the reimbursement landscape evolving? - Four of the seven MACs are now reimbursing for iDose, with ongoing efforts to educate and drive demand for the remaining MACs [44][45] Question: What is the company's path to profitability? - The focus remains on achieving cash flow breakeven in the short term while aiming for operating margins of 30%-35% in the medium to long term [75][76] Question: What are the key challenges in launching Epioxa? - The company is aware of the need for education and awareness in the rare disease space, which requires significant investment and effort [60][62] Question: What will the company be discussing next year? - Management hopes to focus on clinical adoption and the opportunities associated with iDose and Epioxa, moving past reimbursement-related discussions [84]

Financial Data and Key Metrics Changes - The company is transitioning towards generating more pharmaceutical revenue than device revenue, indicating a significant shift in its business model [10] - The convertible debt has been retired, and the company is returning to a normal capital spend, aiming for a cash flow break-even profile [30][31] - The company is experiencing leverage in its model, with revenues increasing while operating expenses grow, indicating improved financial health [31] Business Line Data and Key Metrics Changes - The core MIGS market has seen double-digit growth in the past year but is projected to decline in the coming year, with expectations of mid-single-digit growth [12][15] - The iDose product is cannibalizing some of the stent business, as physicians prefer it due to its clinical profile and outcomes [16][17] - The company is seeing more standalone MIGS procedures, benefiting from the expansion of procedure volumes across various technologies [20][21] Market Data and Key Metrics Changes - Reimbursement for concomitant MIGS is expected to decline in low double digits for 2026, impacting the professional fee side of the business [19] - The company has secured reimbursement from four of the seven MACs, covering about 70% of Medicare lives, with ongoing efforts to educate and push for reimbursement from the remaining MACs [42][43] Company Strategy and Development Direction - The company is focused on building a foundation for rare disease drugs, with Epioxa being the first product aimed at treating keratoconus, a rare disease [61][70] - The strategy includes expanding the iDose product line and developing next-generation products like iDose TREX, which aims to provide longer duration effects [53][54] - The company is committed to changing the standard of care in glaucoma treatment and is optimistic about future growth opportunities in the U.S. glaucoma market driven by iDose [28][80] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the importance of clinical adoption and the potential for significant growth in the interventional glaucoma market [83][84] - The company aims to shift focus from reimbursement-related issues to clinical adoption and the opportunities associated with its products [83] - Management acknowledged the challenges in establishing proper access and coverage for new treatment modalities but remains committed to navigating these complexities [47][48] Other Important Information - The company is working on a next-generation iDose product that could allow for secondary procedures and potentially in-office procedures, enhancing its treatment offerings [55] - The company is investing in education and awareness for keratoconus to improve patient detection and treatment access [60][61] Q&A Session Summary Question: What has surprised you about the iDose launch in 2025? - Management was surprised by the ongoing challenges with MACs and professional fee schedules but remains optimistic about the product's clinical performance and physician enthusiasm [25][27] Question: How do you think about profitability and reaching it? - The focus remains on achieving cash flow breakeven in the short term while aiming for profitability in the medium to long term, leveraging high gross margins [72][74] Question: What do you think investors are missing? - Management believes investors should focus on the long-term growth potential and the breadth of the company's portfolio rather than short-term fluctuations [80]

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.

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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Financial Data and Key Metrics Changes - Glaukos Corporation reported record third quarter consolidated net sales of $133.5 million, up 38% on a reported basis or 37% on a constant currency basis compared to the same quarter last year [7] - The company raised its full year 2025 net sales guidance range to $490 million-$495 million from the previous range of $480 million-$486 million [7][26] Business Line Data and Key Metrics Changes - The U.S. glaucoma franchise achieved record third quarter net sales of $80.8 million, reflecting a strong year-over-year growth of 57%, driven by iDose TR, which generated approximately $40 million in sales [8] - The international glaucoma franchise delivered net sales of $29.4 million, representing a year-over-year growth of 20% on a reported basis and 17% on a constant currency basis [9] - The corneal health franchise reported net sales of $23.3 million, with Photrexa net sales contributing $20.3 million, reflecting a year-over-year growth of 13% [10] Market Data and Key Metrics Changes - Surgeons showed high initial interest in iStent infinite during its commercial launch activities in key European markets, indicating strong potential for growth in the international market [9] - The company continues to scale its international infrastructure to drive growth as a standard of care in major markets worldwide [9] Company Strategy and Development Direction - Glaukos is focused on advancing its strategic priorities, evolving into a diversified ophthalmic leader with growth drivers across multiple geographies and disease states [11] - The FDA approval of Epioxa marks a significant milestone, introducing a new standard of care for keratoconus patients and practitioners [12] - The company plans to increase investments in patient awareness and access to address the challenges of underdiagnosis and under-treatment in keratoconus [18][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Epioxa to deliver exceptional value to patients and the healthcare system, emphasizing the importance of education and awareness in driving patient access [22] - The company anticipates Epioxa will be commercially available in the first quarter of 2026, with a focus on establishing a site of care network and addressing payer adoption challenges [24] - A preliminary revenue guidance range of $600 million-$620 million for 2026 was introduced, reflecting expectations for continued growth from iDose TR and the launch of Epioxa [26][27] Other Important Information - Glaukos has invested over $1 billion in R&D to develop a robust pipeline focused on chronic and rare ophthalmic diseases [21] - The company is transitioning from Photrexa to Epioxa, with plans to discontinue Photrexa's commercial availability in 2026 while ensuring continuity of care for existing patients [25] Q&A Session Summary Question: Discussion on iDose and CAC meeting - Management discussed the rationale behind the CAC meeting, emphasizing the need to educate MACs on the unmet need that iDose addresses and the robust data supporting its utilization [30][31] Question: Confidence in Epioxa pricing and 2026 outlook - Management expressed confidence in executing the pricing strategy for Epioxa, highlighting the importance of educating payers on the therapy's benefits and the cost implications of untreated keratoconus [36][37] Question: iDose performance and future growth - Management provided insights into iDose's performance, noting broad-based growth and the importance of establishing reimbursement structures to support future adoption [44][46] Question: Epioxa's market development and education efforts - Management outlined targeted awareness and education campaigns to identify and reach keratoconus patients earlier in their disease journey, emphasizing the need for a comprehensive approach [77]

Financial Data and Key Metrics Changes - Glaukos Corporation reported record third quarter consolidated net sales of $133.5 million, up 38% on a reported basis or 37% on a constant currency basis compared to the same quarter last year [7] - The company raised its full year 2025 net sales guidance range to $490 to $495 million from a previous range of $480 to $486 million [7][24] Business Line Data and Key Metrics Changes - The U.S. glaucoma franchise achieved record third quarter net sales of $80.8 million, reflecting a strong year-over-year growth of 57%, driven by iDose TR, which generated approximately $40 million in sales [8] - The international glaucoma franchise delivered net sales of $29.4 million, representing a year-over-year growth of 20% on a reported basis and 17% on a constant currency basis [9] - The corneal health franchise reported net sales of $23.3 million, with Votrexa contributing $20.3 million, reflecting a year-over-year growth of 13% [10] Market Data and Key Metrics Changes - Surgeons showed high initial interest in iStent Infinite during its commercial launch activities in key European markets, indicating strong potential for growth in the international market [9] - The company continues to scale its international infrastructure to drive growth as a standard of care in various regions [9] Company Strategy and Development Direction - Glaukos aims to evolve into a diversified ophthalmic leader with transformational growth drivers across multiple geographies and disease states, focusing on glaucoma and rare diseases [11] - The FDA approval of Epioxa marks a significant milestone, introducing a new standard of care for keratoconus patients with a unique incision-free treatment [12][17] - The company plans to increase investments in patient awareness and access to address the challenges of underdiagnosis and under-treatment in keratoconus [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Epioxa to deliver exceptional value to patients and the healthcare system, emphasizing the importance of education and awareness in driving patient access [20][21] - The company anticipates Epioxa will be commercially available in the first quarter of 2026, with a focus on establishing a site of care network and addressing payer adoption challenges [22][24] Other Important Information - Glaukos has invested over $1 billion in R&D to develop a robust pipeline focused on chronic and rare ophthalmic diseases [19] - The company is constructing a new 200,000-square-foot research, development, and manufacturing facility in Huntsville, Alabama, to support long-term growth and innovation [19] Q&A Session Summary Question: Can you discuss the rationale behind the CAC meeting and potential outcomes? - Management highlighted the importance of educating MACs on the unmet need that iDose addresses and the robust FDA data supporting its utilization [30][31] Question: What is the confidence level regarding payer coverage for Epioxa? - Management indicated that education at the payer level is crucial, and they are optimistic about engaging in conversations to establish coverage [36] Question: Can you provide more granularity on the 2026 revenue guidance? - Management stated that the preliminary guidance reflects expectations for Epioxa's rollout and the transition from Votrexa, with more detailed insights to be provided in future calls [41][42] Question: How is iDose performing in terms of utilization? - Management reported strong sales growth for iDose, with contributions from various MAC regions and a growing trend in combination with cataract surgeries [45][46] Question: What are the expectations for patient access to Epioxa? - Management acknowledged that while there may be initial headwinds, they aim to significantly expand patient access over time through education and awareness initiatives [55]

Financial Data and Key Metrics Changes - Glaukos Corporation reported record third quarter consolidated net sales of $133.5 million, up 38% on a reported basis or 37% on a constant currency basis compared to the same quarter last year [6][7] - The company raised its full year 2025 net sales guidance range to $490 to $495 million from a previous range of $480 to $486 million [6][26] Business Line Data and Key Metrics Changes - The U.S. glaucoma franchise achieved record third quarter net sales of $80.8 million, reflecting a year-over-year growth of 57%, driven by contributions from iDose TR, which generated approximately $40 million in sales [7][8] - The international glaucoma franchise delivered net sales of $29.4 million, representing a year-over-year growth of 20% on a reported basis and 17% on a constant currency basis [9] - The corneal health franchise reported net sales of $23.3 million, with Votrexa contributing $20.3 million, reflecting a year-over-year growth of 13% [10][11] Market Data and Key Metrics Changes - The company noted strong growth in both U.S. and international markets, with the U.S. glaucoma franchise being a significant contributor to overall sales growth [7][9] - Surgeons showed high initial interest in iStent Infinite during its commercial launch activities in Europe, indicating a positive market reception [9] Company Strategy and Development Direction - Glaukos is focused on advancing its strategic priorities, evolving into a diversified ophthalmic leader with growth drivers across multiple geographies and disease states [11][26] - The company plans to increase investments in patient awareness and access for Epioxa, aiming to address the challenges of underdiagnosis and under-treatment in keratoconus [18][19] - A new 200,000-square-foot research, development, and manufacturing facility is being established in Huntsville, Alabama, to support long-term growth and innovation [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Epioxa to transform keratoconus treatment and emphasized the importance of education and awareness in expanding patient access [21][56] - The company anticipates a slow and methodical rollout for Epioxa in 2026, with initial patient access being gated by site of care network deployment and payer adoption [24][40] - Preliminary revenue guidance for 2026 is set at $600 million to $620 million, reflecting expectations for continued growth from iDose TR and the launch of Epioxa [26][27] Other Important Information - The FDA approval of Epioxa marks a significant milestone, being the first and only FDA-approved topical drug therapy for keratoconus that does not require removal of the corneal epithelium [12][13] - The company has invested over $1 billion in R&D to develop a robust pipeline focused on chronic and rare ophthalmic diseases [20] Q&A Session Summary Question: Can you discuss the rationale of the CAC meeting and potential outcomes? - Management highlighted the importance of educating MACs on the unmet need that iDose addresses and the robust data supporting its utilization [32][34] Question: What are your views on payer coverage and reimbursement for Epioxa? - Management indicated that gaining access for Epioxa will involve educating payers about the benefits and costs associated with keratoconus progression [38][56] Question: Can you provide more granularity on the 2026 revenue guidance? - Management stated that the preliminary guidance reflects expectations from various franchises and will provide more detailed views in the fourth quarter call [44][45] Question: How is iDose performing and what is the mix of standalone versus combination procedures? - Management reported strong sales growth for iDose, with a mix of utilization in both standalone and combination procedures, though specific tracking is not available [47][50] Question: What investments are being made for Epioxa's market development? - Management emphasized targeted awareness and education efforts, particularly within the optometric community, to drive early diagnosis and treatment [81]

Core Insights - Glaukos Corporation (NYSE:GKOS) is positioned as a leading investment opportunity in the medical device sector, particularly with the upcoming PDUFA date for its Epioxa medication on October 20 [1] - Stifel has reaffirmed a Buy rating and a price target of $115 for Glaukos, supported by a survey indicating strong uptake and volume projections for Epioxa among ophthalmologists [1][2] Company Overview - Glaukos Corporation specializes in developing innovative treatments for eye diseases, including glaucoma and corneal issues, utilizing micro-invasive surgical instruments and drug delivery systems to improve patient outcomes [3] Market Potential - The findings from Stifel's survey suggest that Epioxa is expected to capture a significant share of the corneal cross-linking (CXL) operation volume, contributing to market growth [2] - The survey also indicates minimal patient warehousing prior to Epioxa's launch, which alleviates previously identified concerns by Glaukos management and supports an optimistic outlook for Corneal Health revenue in the latter half of 2025 and into 2026 [2]