Company Performance - Glaukos reported a quarterly loss of $0.40 per share, better than the Zacks Consensus Estimate of a loss of $0.43, and an improvement from a loss of $0.63 per share a year ago, representing an earnings surprise of 6.98% [1] - The company posted revenues of $105.5 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 4.71%, and showing an increase from year-ago revenues of $82.37 million [2] - Over the last four quarters, Glaukos has surpassed consensus EPS estimates two times and topped consensus revenue estimates four times [2] Stock Outlook - Glaukos shares have increased approximately 7.1% since the beginning of the year, outperforming the S&P 500's gain of 4.5% [3] - The current consensus EPS estimate for the coming quarter is -$0.35 on revenues of $106.44 million, and -$1.08 on revenues of $477.69 million for the current fiscal year [7] - The estimate revisions trend for Glaukos is favorable, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Instruments industry, to which Glaukos belongs, is currently in the top 34% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Performance - Fourth quarter 2024 net revenues reached $105.5 million, a 28% increase compared to Q4 2023, while full year 2024 revenues totaled approximately $383.5 million, up 22% from 2023[6][7] - Total net sales for 2024 reached $383.5 million, a 21.9% increase compared to $314.7 million in 2023[68] - Net sales for Q4 2024 reached $105.5 million, a 28.1% increase from $82.4 million in Q4 2023[60] - International glaucoma sales for 2024 were $103.7 million, reflecting a year-over-year growth of 21.2% from $85.6 million in 2023[68] - U.S. Glaucoma net revenues for Q4 2024 were approximately $56.3 million, reflecting a 45% year-over-year growth, with full year revenues of approximately $199.6 million, a 32% increase from 2023[10][11] - International Glaucoma net revenues for Q4 2024 were approximately $27.9 million, representing a 28% increase year-over-year, while full year revenues were approximately $103.7 million, up 21% from 2023[13][14] - Corneal Health net revenues for Q4 2024 were approximately $21.4 million, a 2% decline year-over-year, with full year revenues of approximately $80.2 million, reflecting a 3% increase from 2023[16][17] Expenses and Losses - Non-GAAP SG&A expenses for 4Q 2024 were $68.6 million, reflecting a 10% increase year-over-year from $62.3 million in 4Q 2023[24] - Non-GAAP R&D expenses for 4Q 2024 were $36.5 million, a 1% decrease year-over-year from $37.1 million in 4Q 2023[24] - The company reported a net loss of $146.4 million for 2024, with a basic and diluted net loss per share of $2.77[65] - Non-GAAP net loss for 4Q 2024 was $22.2 million, compared to a net loss of $30.6 million in 4Q 2023[24] - The company reported a net loss of $33.6 million in Q4 2024, an improvement from a net loss of $36.8 million in Q4 2023[60] - Basic and diluted net loss per share for Q4 2024 was $0.60, compared to $0.75 in Q4 2023[60] - Operating expenses for 2024 totaled $261.2 million, compared to $224.1 million in 2023, indicating a significant increase in costs[65] Margins and Profitability - Fourth quarter 2024 gross margin was 82%, a decrease of 150 basis points year-over-year from 84% in 4Q 2023[24] - Gross profit for Q4 2024 was $76.9 million, compared to $63.5 million in Q4 2023, resulting in a gross margin of 72.9%[60] - Gross margin improved to 82.4% in 2024, up from 83.0% in 2023, despite a cost of sales of $67.5 million after adjustments[65] Future Outlook - The company expects full-year 2025 global consolidated net sales to be between $475 million and $485 million, considering various market dynamics and potential headwinds[19] - The company is preparing for potential FDA approval and commercial launch of Epioxa™ by the end of 2025[21] - In 2025, the company aims to advance enrollment in the PMA pivotal trial for iStent infinite and commence the US IDE trial for PRESERFLO MicroShunt[36] - The company has 14 pipeline programs entering 2025, focusing on glaucoma, corneal disorders, and retinal diseases[37] Research and Development - The company has invested over $700 million into R&D programs since 2018, with recent updates including NDA submission for Epioxa™ and advancements in multiple clinical programs[21][20] - iDose TR, a new glaucoma treatment, is expected to reshape glaucoma management, with positive clinical outcomes and feedback from trained surgeons[11] - The company is advancing commercial launch activities for iDose TR and iStent infinite, with new reimbursement codes expected to enhance patient access and coverage[18] Cash and Assets - Cash position increased by $56.4 million quarter-over-quarter, totaling $323.6 million in 4Q 2024[24] - Cash and cash equivalents increased to $169.6 million as of December 31, 2024, from $93.5 million a year earlier[61] - The company’s total assets as of December 31, 2024, were $974.8 million, compared to $940.4 million at the end of 2023[61] Compliance and Market Dynamics - The company emphasizes the importance of compliance with federal healthcare programs and maintaining adequate reimbursement coverage for its products[56] - The company anticipates potential headwinds in U.S. Glaucoma stent business due to final LCDs and competition from combo-cataract MIGS globally[19] Product Development and Marketing - The Radius XR platform is being marketed to enhance eye disease detection and patient management[49] - The company has received FDA clearance for its Radius XR wearable patient engagement and diagnostic system and the iAccess precision goniotomy[51] - The company is focused on successfully commercializing its iDose TR therapy and expanding its product offerings[56]

Core Insights - Wall Street analysts anticipate Glaukos (GKOS) will report a quarterly loss of $0.43 per share, reflecting a year-over-year increase of 31.8% [1] - Expected revenues for Glaukos are projected at $100.75 million, which represents a 22.3% increase from the same quarter last year [1] - There have been no revisions in the consensus EPS estimate over the last 30 days, indicating analysts' stability in their forecasts [1] Revenue Estimates - Analysts estimate 'Revenues- Corneal Health' to be $21.53 million, showing a decrease of 1.2% from the prior-year quarter [4] - 'Revenues- Glaucoma' is expected to reach $79.53 million, indicating a year-over-year increase of 31.3% [4] - The average prediction for 'Revenues- Glaucoma- United States' stands at $54.32 million, reflecting a significant increase of 40.3% year-over-year [4] Regional Revenue Projections - The consensus estimate for 'Revenues- Corneal Health- United States' is $19.10 million, indicating a year-over-year decline of 3% [5] - 'Revenues- International' are projected to be $27.40 million, suggesting a year-over-year increase of 14.3% [5] - 'Revenues- United States' are expected to reach $73.43 million, reflecting a 25.7% increase from the previous year [5] Additional Revenue Insights - Analysts project 'Revenues- Glaucoma- International' to be $25.05 million, indicating a year-over-year increase of 14.6% [6] Stock Performance - Glaukos shares have experienced a decline of 2% over the past month, contrasting with the Zacks S&P 500 composite's increase of 4.7% [7] - With a Zacks Rank of 3 (Hold), Glaukos is expected to closely follow overall market performance in the near term [7]

iDose TR Clinical Data and Market Impact - iDose TR demonstrated sustained efficacy in a 36-month follow-up analysis, with 70% of patients remaining well-controlled on the same or fewer IOP-lowering medications compared to 58% in the control group [4] - The implant achieved a mean IOP reduction of 11.3 mmHg (44%) at six months post-operation in a Phase 4 study involving 60 open-angle glaucoma patients [6] - iDose TR received FDA approval in December 2023 for reducing intraocular pressure in patients with ocular hypertension or open-angle glaucoma [2] iDose TREX Development - Glaukos initiated Phase 2b/3 clinical trials for iDose TREX, the next-generation sustained-release platform with nearly double the drug capacity of iDose TR [8] - Early-stage clinical updates suggest iDose TREX could extend therapeutic efficacy duration and enhance patient outcomes [8] Financial Performance and Market Position - GKOS shares gained 17.7% in the past six months against the industry's 0.6% decline [3] - The company's glaucoma franchise witnessed revenue growth in Q3, driven by iStent portfolio and growing contributions from iDose TR [11] - Glaukos successfully executed detailed launch plans for iDose TR in Q3, with the unique permanent J-code becoming effective on July 1 [11] Competitive Landscape - The positive clinical data on iDose TR and advancement of iDose TREX provide Glaukos with a significant competitive advantage in the ophthalmic market [9] - iDose positions Glaukos as a leader in procedural pharmaceutical solutions by addressing critical challenges in glaucoma treatment [9]

Stock Performance and Market Position - Glaukos Corporation's stock reached a new 52-week high of $155 76 on Jan 6, closing at $155 20 [1] - The stock has surged 89 3% over the past year, outperforming the industry's 6 4% rise and the S&P 500's 26 8% growth [1] - The company has a market capitalization of $8 56 billion [2] Financial Projections and Growth Drivers - Glaukos projects earnings growth of 16 7% for 2024 and 42 8% for 2025 [2] - Revenue is expected to grow 26 3% in 2025 [2] - The iStent portfolio significantly boosted glaucoma franchise revenues in the first nine months of 2024 [6] - The launch of iDose TR in Q2 2024 is enhancing revenue growth, with a permanent J-code effective July 1 likely to increase patient access and drive future sales [6] Product Portfolio and Pipeline - Glaukos submitted a New Drug Application (NDA) to the FDA for Epioxa (Epi-on), its next-generation corneal cross-linking iLink therapy for keratoconus [5] - The company is advancing its robust pipeline of novel, dropless platform technologies designed to improve outcomes for patients with chronic eye diseases [8][9] - The development of the iLink system using Epioxa therapy was delayed following a pre-NDA submission meeting in 2022 that recommended a second confirmatory study [10] International Market Expansion - Glaukos' international glaucoma franchise recorded 17% growth compared to the same period in 2023 [7] - The company sells products through subsidiaries in 17 countries and independent distributors in other markets [7] - International operations are expected to support long-term growth [7] Competitive Landscape - Glaukos faces stiff competition from medical companies, academic and research institutions, and other entities developing new drugs, therapies, medical devices, or surgical procedures for glaucoma [11] - Competitors include divisions of larger companies with greater resources and smaller companies targeting specific products or geographies [11] Industry Comparison - Cardinal Health, Inc (CAH) has a Zacks Rank 2 (Buy) and an estimated long-term growth rate of 10 2%, with shares gaining 13 8% compared to the industry's 1 2% growth [12][13] - ResMed Inc (RMD) has a Zacks Rank 2 and an estimated long-term growth rate of 14 8%, with shares gaining 36 1% compared to the industry's 8 5% growth [13] - Boston Scientific Corporation (BSX) has a Zacks Rank 2 and an estimated long-term growth rate of 13 8%, with shares rallying 56 3% compared to the industry's 8 5% growth [14]

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]