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

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

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

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]