Glaukos Corporation (GKOS) and Epioxa - Glaukos Corporation submitted a New Drug Application (NDA) to the FDA for Epioxa, its next-generation corneal cross-linking iLink therapy for treating keratoconus [13] - Epioxa is a novel therapy designed to preserve the corneal epithelium, reduce procedure time, improve patient comfort, and shorten recovery [8] - If approved, Epioxa will be the first non-invasive corneal cross-linking therapy that does not require removal of the corneal epithelium [9] - The NDA submission includes data from two Phase 3 pivotal trials, which successfully achieved pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles [1] - The second Phase 3 confirmatory pivotal trial for Epioxa showed a clinically relevant and statistically significant improvement in maximum corneal curvature (Kmax) at 12 months from baseline [10] Market and Industry Prospects - The global keratoconus treatment market was valued at $0.31 billion in 2023 and is anticipated to reach $0.41 billion by 2032 at a CAGR of 3.7% [18] - Rising exposure to sun and UV rays are the prime market drivers for the keratoconus treatment market [18] - Glaukos' first-generation iLink therapy, Photrexa or Epi-off, is the first and only FDA-approved therapy shown to slow or halt keratoconus progression [2] Financial Performance and Stock Trends - Glaukos currently has a market capitalization of $8.32 billion [16] - The Zacks Consensus Estimate for fiscal 2024 revenues is pegged at $378.7 million, indicating 20.3% growth from fiscal 2023 [16] - GKOS shares have gained 80.2% in the past year compared to the industry's growth of 4.5% and the S&P 500's gain of 26.6% [14] - Following the NDA submission announcement, GKOS shares moved 1.7% lower to $148.36 [14] Competitor Analysis - Accuray (ARAY) has an estimated growth rate of 1200% for 2025 but missed earnings estimates in three of the trailing four quarters with an average negative surprise of 141.97% [4] - ARAY shares have gained 8.8% in the past six months against the industry's 1% decline [5] - Abbott Laboratories (ABT) has an estimated earnings growth rate of 10% for 2025 and delivered a trailing four-quarter average earnings surprise of 1.64% [21] - ABT shares have risen 8.5% in the past six months compared to the industry's 7.2% growth [6] - Masimo (MASI) has an estimated growth rate of 11.8% for 2025 and surpassed earnings estimates in each of the trailing four quarters with an average surprise of 17.10% [12][20] - MASI shares have risen 31.7% against the industry's 1% decline in the past six months [20]

Market Analysis and Expertise - Bernard Holdings provides objective views on market directional bias and technical expertise, bridging complex relationships between value drivers, capital flows, and price action [1] - The company's research covers investment securities and futures & options markets, catering to a diverse range of market participants including speculators, hedgers, long-term traders, and the public [1] Stock Performance and Valuation - Glaukos Corporation (NYSE: GKOS) has seen a significant stock price increase of +90% since August FY'23, surpassing additional price objectives [3] - The company is currently valued at over 12x book value and 9x EV/IC, reflecting investor recognition of its value [3] Research and Disclosure - All research provided by Bernard Holdings is strictly for informational purposes and not to be considered investment advice [1] - Seeking Alpha's analysts, including third-party authors, may not be licensed or certified by any institute or regulatory body, and their views may not reflect those of Seeking Alpha as a whole [2]

Industry Overview - The medical device industry faced significant challenges in 2024, including regulatory bottlenecks, supply-chain disruptions, and geopolitical tensions, particularly in the U.S., Europe, and China [2] - Global supply-chain disruptions, initially triggered by the COVID-19 pandemic, persisted in 2024, with rising raw material costs and semiconductor shortages heavily affecting device manufacturing [3] - Inflation in the United States and Europe increased operational expenses and reduced profit margins, making it difficult for companies to balance price increases with affordability for healthcare providers [3] - China's medical device market, the second largest globally, encountered trade restrictions, domestic competition, and regulatory shifts emphasizing "localization," creating a tougher operating environment for foreign firms [4] - Looking ahead to 2025, challenges are unlikely to dissipate entirely, with companies needing to invest in localized manufacturing and navigate regulatory complexities in China [5] Company Highlights Intuitive Surgical (ISRG) - The company designs, manufactures, and markets the da Vinci surgical system, Ion endoluminal system, and related instruments and accessories [7] - Intuitive Surgical ended the third quarter of 2024 on a positive note, beating estimates on both revenue and earnings, driven by growth in da Vinci and Ion procedure volumes [7] - The company expects a nearly three percentage point headwind for revenues in 2024 due to weakness in bariatric procedures and challenges in China [9] - Earnings growth rate for 2025 is pegged at 14.1%, with a Zacks Consensus Estimate indicating a 17% year-over-year rise in revenues [10] Globus Medical (GMED) - The company develops and commercializes healthcare solutions for patients with musculoskeletal disorders, with sales operations in 51 countries [11] - Globus Medical is expanding its global presence and integrating the NuVasive merger, which is expected to generate additional revenues in 2025 [12] - The company faces intensifying competitive pricing pressure, which remains a major headwind [13] - Earnings growth rate for 2025 is pegged at 16.1%, with a Zacks Consensus Estimate indicating a 6.7% year-over-year rise in revenues [14] Glaukos (GKOS) - The company focuses on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies for glaucoma [15] - Glaukos has shown strength in its iStent product line and launched iDose TR during the third quarter of 2024, with plans to submit an NDA for its corneal cross-linking therapy, Epioxa, by the end of 2024 [15] - The company has experienced higher costs for certain components and raw materials due to supply-chain challenges and inflationary pressures [17] - Earnings growth rate for 2025 is pegged at 44.4%, with a Zacks Consensus Estimate indicating a 26.3% year-over-year rise in revenues [18] Veracyte (VCYT) - The company commercializes advanced genomic tests and has shown robust strength in its testing business [19] - Veracyte's Affirma and Decipher Prostrate tests are gaining market share and advancing on the reimbursement front [20] - The company is experiencing declines in biopharma and other services revenues due to reduced customer projects and extended sales cycles [21] - Earnings growth rate for 2025 is pegged at 65.8%, with a Zacks Consensus Estimate indicating a 9.8% year-over-year rise in revenues [21] Inogen (INGN) - The company develops, manufactures, and markets portable oxygen concentrators, with a unique direct-to-customer business model [22] - Inogen's buyout of Physio-Assist and focus on advancing its innovation pipeline are expected to drive growth [22] - The company faces macroeconomic concerns, Medicare headwinds, forex volatility, and stiff competition [23] - Earnings growth rate for 2025 is pegged at 11.9%, with a Zacks Consensus Estimate indicating a 3.9% year-over-year improvement in revenues [23] Innovation and Growth Prospects - Despite persistent challenges, innovation remains a bright spot for the medical device industry, with companies like Intuitive Surgical, Globus Medical, Glaukos, Veracyte, and Inogen showing significant gains in 2024 [6] - These companies have favorable fundamentals and are expected to continue reaping benefits for their investors in 2025 [6]

Company Overview - Glaukos Corporation (GKOS) is a leading ophthalmic medical technology and pharmaceutical company with a market capitalization of $7.65 billion [2] - The company's shares have risen 71.6% year to date, outperforming the industry's 6.4% growth and the S&P 500 Index's 27.3% increase [1] - Glaukos projects earnings growth of 16.3% for 2024 and 44.4% for 2025, with revenue expected to grow 26.3% in 2025 [2] - The company has a trailing four-quarter average earnings surprise of 3.24% [3] Key Growth Catalysts - Strong demand for Glaukos' leading product, iStent, and its international glaucoma and Corneal Health products have driven investor confidence and share price growth [4] - The growing use of iStent infinite for glaucoma patients, supported by clinical education and better market access, is a significant growth driver [5] - Five out of seven Medicare Administrative Contractors have issued draft local coverage determinations for iStent infinite, which is expected to improve patient access [5] - Glaukos raised its full-year revenue guidance to $377-$379 million from $370-$376 million due to high product demand [6] Product Portfolio Expansion - The iStent portfolio significantly boosted Glaukos' glaucoma franchise revenues in the first nine months of 2024 [7] - The launch of iDose TR in the second quarter is already enhancing revenue growth, with a permanent J-code effective from July 1 likely to increase patient access and drive future sales [7] - Glaukos is investing in its product pipeline, including Epioxa, a corneal cross-linking therapy expected to undergo NDA submission by the end of 2024 [8] - The company is preparing for a pivotal study on its next-generation iDose therapy, iDose TREX, which is set to begin soon [9] International Expansion - Glaukos sells its products through subsidiaries in 17 countries and independent distributors in other markets [10] - The company's international glaucoma franchise reported record sales of $83.5 million in the first nine months of 2024, reflecting 17% year-over-year growth [10] Challenges - Glaukos depends on a limited number of third-party suppliers, including some sole suppliers, for components of the iStent, iStent inject models, and other pipeline products [11] - If these suppliers fail to provide sufficient quantities of components or drugs in a timely manner or on acceptable terms, Glaukos would need to seek alternative sources [12] Financial Estimates - The bottom-line estimate for GKOS is pegged at a loss of $1.90 per share for 2024, which narrowed 30 cents in the past 60 days [13] - The Zacks Consensus Estimate for 2024 revenues is pinned at $378.7 million, indicating growth of 20.3% from the top line recorded in 2023 [13] Industry Comparison - Other top-ranked stocks in the broader medical space include Masimo (MASI), Accuray (ARAY), and AxoGen (AXGN) [14] - Masimo has an estimated growth rate of 11.8% for 2025 and has seen its shares rise 48.6% year to date [14] - Accuray has an estimated growth rate of 1200% for 2025 but has seen its shares lose 25.8% year to date [15] - AxoGen has an estimated earnings growth rate of 252% for 2025 and has seen its shares rise 111.4% year to date [16]

Industry Overview - The medical device industry faced significant challenges in 2024, including regulatory bottlenecks, supply-chain disruptions, and geopolitical tensions, particularly in the U.S., Europe, and China [1] - Supply-chain disruptions, initially triggered by the COVID-19 pandemic, persisted in 2024, with rising raw material costs and semiconductor shortages heavily affecting device manufacturing [2] - Inflation in the U.S. and Europe increased operational expenses and reduced profit margins, making it difficult for companies to balance price increases with affordability for healthcare providers [2] - China's medical device market encountered unique challenges, including trade restrictions, domestic competition, and regulatory shifts emphasizing "localization," which compelled international companies to form joint ventures [3] Outlook for 2025 - Challenges in the medical device industry are unlikely to dissipate entirely in 2025, with companies seeking streamlined regulatory processes in the U.S. and Europe, though real change will take years [4] - Supply-chain resilience will require substantial investments in localized manufacturing, while navigating regulatory and market complexities in China will demand strategic partnerships and localization strategies [4] - The possibility of a tariff war between the U.S. and China, especially with Trump's potential return to the White House, could disrupt supply chains and increase material costs [4] Company Performance and Prospects Intuitive Surgical (ISRG) - Intuitive Surgical ended Q3 2024 on a positive note, beating estimates, with revenue growth driven by increased da Vinci procedure volume and strong Ion procedure growth [7][8] - The company expects a nearly three percentage point headwind for revenues in 2024 due to weakness in bariatric procedures and challenges in China from increasing provincial robotic competition and delayed tenders [9] - ISRG's earnings growth rate for 2025 is pegged at 14.1%, with a Zacks Consensus Estimate indicating a 17% year-over-year rise in revenues [10] Globus Medical (GMED) - Globus Medical is expanding its global presence, driven by market growth in the U.S. spine and increasing international momentum, with significant synergy from the NuVasive merger [11] - The company launched four new products in Q3 2024, which are likely to generate additional revenues in 2025 [11] - GMED's earnings growth rate for 2025 is pegged at 16.1%, with a Zacks Consensus Estimate indicating a 6.7% year-over-year rise in revenues [13] Glaukos (GKOS) - Glaukos is focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies, with strength in the iStent product line and the launch of iDose TR in Q3 2024 [14] - The company is targeting NDA submission for its corneal cross-linking therapy, Epioxa, by the end of 2024 [14] - GKOS' earnings growth rate for 2025 is pegged at 44.4%, with a Zacks Consensus Estimate indicating a 26.3% year-over-year rise in revenues [17] Veracyte (VCYT) - Veracyte continues to display robust strength in the testing business, with market share gains driven by Affirma's differentiation and strong interest in the new GRID ROU tool [18] - The company is experiencing significant declines in biopharma and other services revenues due to reductions in customer projects, extended sales cycles, and spending constraints [19] - VCYT's earnings growth rate for 2025 is pegged at 65.8%, with a Zacks Consensus Estimate indicating a 9.8% year-over-year rise in revenues [20] Inogen (INGN) - Inogen's direct-to-customer business model and solid product suite, fueled by continued innovations, are expected to strengthen its foothold in the global long-term oxygen therapy market [21] - The company faces macroeconomic concerns, including the possibility of another public health crisis, Medicare headwinds, forex volatility, and stiff competition [22] - INGN's earnings growth rate for 2025 is pegged at 11.9%, with a Zacks Consensus Estimate indicating a 3.9% year-over-year improvement in revenues [22]

Company Overview - Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company headquartered in San Clemente, CA, focused on developing and commercializing surgical devices and sustained pharmaceutical therapies for glaucoma treatment [2] - The company's flagship product, iStent, is the first FDA-approved surgical device for insertion during cataract surgery [2] Stock Performance - Glaukos' shares have surged 77.9% year-to-date, significantly outperforming the industry's 3.4% growth and the S&P 500's 24.5% rise [1] - The company's strong fundamentals and growth opportunities make it a solid wealth creator for investors [1] Revenue Growth - Glaukos reported Q3 2024 revenues of $96.7 million, a 23.9% year-over-year increase [5] - The company raised its full-year 2024 sales guidance to $377-$379 million from the prior estimate of $370-$376 million [5] - Revenues for 2024 and 2025 are anticipated to rise 20.3% and 25.8%, respectively, to $378.7 million and $476.2 million [11] Product Pipeline - Glaukos' glaucoma franchise saw revenue growth driven by its iStent portfolio and contributions from iDose TR [4] - The company successfully executed launch plans for iDose TR, with a unique permanent J-code effective July 1, 2024, likely to increase patient access and drive sales growth [4] - Glaukos is on track to submit an NDA for its corneal cross-linking therapy, Epioxa, by the end of 2024, following successful Phase 3 trial results [6][7] - The company plans to initiate a pivotal study for its next-generation iDose therapy, iDose TREX, by year-end [7] International Expansion - Glaukos' International Glaucoma franchise delivered record sales of $83.5 million in the first nine months of 2024, representing 17% year-over-year growth [8] - The company is focused on scaling up its global infrastructure and establishing MIGS as a standard of care in multiple regions [8] Financial Estimates - The loss per share estimate for 2024 and 2025 implies a year-over-year improvement of 13.7% and 42.6%, respectively, to $1.96 and $1.13 [10] - The Zacks Consensus Estimate for the company's 2024 loss has narrowed by 10.5% in the past 30 days [11] Industry Comparison - Masimo (MASI), AngioDynamics (ANGO), and Globus Medical (GMED) are other top-ranked stocks in the medical industry [12] - Masimo has an estimated growth rate of 13.5% for 2025 and has seen its shares rise 40.7% year-to-date [13] - AngioDynamics has an estimated growth rate of 38.2% for 2025 but has seen its shares lose 14% year-to-date [13] - Globus Medical has an estimated long-term growth rate of 14.1% and has seen its shares rise 56.9% year-to-date [14]

Financial Performance - Glaukos reported revenue of $96 67 million for the quarter ended September 2024, a year-over-year increase of 23 9% [1] - EPS for the quarter was -$0 28, an improvement from -$0 50 in the same period last year [1] - The revenue surpassed the Zacks Consensus Estimate of $91 32 million by 5 86% [1] - EPS also exceeded the consensus estimate of -$0 52, with a surprise of +46 15% [1] Revenue Breakdown by Segment - Revenues from Glaucoma in the United States were $51 57 million, a 35 5% increase year-over-year and above the five-analyst estimate of $47 06 million [3] - Revenues from Corneal Health in the United States were $18 45 million, a 6 4% increase year-over-year and slightly above the five-analyst estimate of $17 98 million [3] - International revenues totaled $26 65 million, a 17 7% increase year-over-year and above the five-analyst estimate of $25 93 million [3] - Revenues from Corneal Health internationally were $2 19 million, a 7 8% decrease year-over-year and below the five-analyst estimate of $2 50 million [3] - Total United States revenues were $70 02 million, a 26 4% increase year-over-year and above the five-analyst estimate of $65 04 million [3] - Revenues from Glaucoma internationally were $24 47 million, a 20 7% increase year-over-year and above the five-analyst estimate of $23 42 million [3] - Total Corneal Health revenues were $20 64 million, a 4 7% increase year-over-year and slightly above the six-analyst estimate of $20 40 million [3] - Total Glaucoma revenues were $76 03 million, a 30 3% increase year-over-year and above the six-analyst estimate of $71 18 million [3] Stock Performance - Glaukos shares returned +3 9% over the past month, outperforming the Zacks S&P 500 composite's -0 5% change [4] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [4]

Financial Performance - Third-quarter sales reached $96.7 million, a 24% year-over-year increase, surpassing the consensus estimate of $91.49 million [1] - Adjusted EPS loss improved to $(0.28) from $(0.50) year-over-year, beating the consensus estimate of $(0.48) [1] - Gross margin for Q3 2024 was approximately 77%, up from 76% in the same period in 2023 [1] - Non-GAAP gross margin for Q3 2024 was approximately 82%, slightly down from 83% in the same period in 2023 [2] Product Segment Performance - Glaucoma products recorded net sales of $76.0 million, a 30% year-over-year increase [2] - Corneal Health net sales reached $20.6 million, a 5% year-over-year increase [2] Management Commentary - The company attributed its record third-quarter results to successful global execution of key strategic plans and strong business momentum [2] Guidance and Market Reaction - The company raised its 2024 net sales guidance to $377 million-$379 million, up from prior guidance of $370 million-$376 million and above the consensus estimate of $373.758 million [3] - Despite strong results, the stock declined 9% in after-hours trading, partly due to a modest $3 million increase in the high-end guidance [3] - The stock was down 1.16% at $129.83 at publication time [4] Industry and Competitive Landscape - The company anticipates peak headwinds from the Medicaid Drug Rebate Program (MDRP) in Q4 2024 [3] - Increasing competition in the international glaucoma segment is expected, aligning with prior management guidance [3] - Competitive pressures may ease with upcoming key product approvals, which are set to expand the company's international pipeline in the coming quarters [4]

Glaukos Corporation (GKOS) reported third-quarter 2024 adjusted loss of 28 cents per share, surpassing the Zacks Consensus Estimate by 46.15%. The figure was narrower than the year-ago quarter’s adjusted loss of 50 cents per share.The GAAP loss per share was 39 cents compared with the prior-year quarter’s reported loss of 63 cents.Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.Revenue DetailsGlaukos registered revenues of $96.7 million in the third quarter, up 23.9% year over year ...

Financial Data and Key Metrics Changes - Glaukos Corporation reported record third quarter consolidated net sales of $96.7 million, representing a 24% increase compared to the same quarter last year [8] - The company raised its full year 2024 net sales guidance range to $3.77 billion to $3.79 billion, up from the previous range of $3.70 billion to $3.76 billion [8] Business Line Data and Key Metrics Changes - The U.S. Glaucoma franchise achieved record third quarter sales of $51.6 million, reflecting a strong year-over-year growth of 35%, driven by contributions from iDose TR and the iStent portfolio [11] - The procedural pharmaceutical franchise, iDose TR, is advancing with positive outcomes and feedback from trained surgeons, indicating its potential to reshape glaucoma management [13][18] - The international glaucoma franchise generated sales of $24.5 million, with a year-over-year growth of 21%, supported by the new French CEPS agreement [20] - The Corneal Health franchise reported sales of $20.6 million, with a 5% year-over-year growth, including Photrexa net sales of $17.9 million [21] Market Data and Key Metrics Changes - The company noted that five of the seven MACs issued final MIGS LCDs, establishing coverage for iStent infinite, which is expected to enhance market access [11][12] - The international market is facing potential headwinds due to trialing new standards products as the company enters 2025 [20] Company Strategy and Development Direction - Glaukos aims to advance glaucoma treatment by driving earlier intervention and expanding access to interventional glaucoma tools [9][10] - The company is focused on increasing reimbursement confidence and market access for iDose TR, with plans to expand efforts into the commercial arena in 2025 [16][18] - The company is also investing in its pipeline, with a focus on Epioxa, a next-generation corneal cross-linking therapy, expected to support an NDA submission by the end of 2024 [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the team's ability to execute and drive clinical adoption of interventional glaucoma treatments, with a focus on establishing consistent professional fee payments [30][33] - The company anticipates challenges in the international market due to currency fluctuations and increased competition [39][98] - Management remains optimistic about the potential for profitability in the future, particularly as iDose sales ramp up [91] Other Important Information - The company issued a Notice of Redemption for the remaining $57.5 million in principal amount of its convertible Senior Notes due 2027, which is expected to strengthen its capital position [24][25] - The FDA has agreed that the clinical data package for Epioxa is sufficient to support an NDA submission, indicating progress in the regulatory pathway [70][71] Q&A Session Summary Question: Can you discuss the learnings from the iDose launch? - Management highlighted the importance of clinical outcomes and reimbursement confidence as key factors for the successful adoption of iDose TR [29][30] Question: What are the expectations for iDose revenue in Q4 and 2025? - Management indicated that iDose TR sales are expected to continue growing, with a projected revenue of approximately $10 million in Q4 [35][36] Question: How is the reimbursement landscape evolving for iDose? - Management noted that while some MACs are paying in a normalized manner, others are still navigating the transition, which may impact reimbursement dynamics [75][76] Question: What is the outlook for Epioxa and its reimbursement pathway? - Management confirmed that Epioxa will be covered under an existing T-code and plans to apply for a J-code following its approval [87][88] Question: How does the company view its operating expenses and cash flow breakeven? - Management stated that while the focus is on achieving cash flow breakeven, there is potential for profitability in the coming quarters as iDose sales increase [91][92]