GLAUKOS Corp

Glaukos is an ophthalmic pharmaceutical and medical technology company focused on developing novel, dropless therapies and commercializing associated products for the treatment of glaucoma, corneal disorders, and retinal disease. The company first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device, the iStent, commercially in 2012. Ophthalmic diseases and disorders are a national and global health concern and, as the population ages, the number of individuals with vision impairment and blindness is increasing. Improving access to cost-effective tools is increasing the diagnosis of sight-threatening ocular diseases globally and driving demand for innovative products, technologies, and therapies that improve clinical outcomes, demonstrate favorable safety profiles and provide ease of use and reliability.

The medical technology and pharmaceutical industries are highly competitive. Glaukos competes with many companies, including divisions of companies much larger than itself that may have greater resources and name recognition, and smaller companies that compete against specific products or in certain geographies. In glaucoma, the company's MIGS offerings primarily compete against Alcon, Sight Sciences, AbbVie, Iantrek, and New World Medical. Its procedural pharmaceutical product competes with AbbVie Inc. In corneal disorders, Glaukos currently has the only FDA approved bio-activated pharmaceutical therapy for the treatment of keratoconus; however, it is aware of companies such as Epion Therapeutics that are developing competitive corneal cross-linking products, and there are certain pharmacies that compound pharmaceuticals that may be used by certain physicians in place of its Photrexa or Epioxa products, and globally it competes against numerous providers of corneal crosslinking therapies such as PeschkeTrade GmBH. The company believes it competes primarily on the basis of clinical superiority supported by extensive data and innovative features that enhance patient benefit, product performance, and safety.

Glaukos generates revenue primarily from sales of its products in the United States and internationally. Customers are primarily comprised of ambulatory surgery centers, hospitals and physician private practices, with distributors being used in certain international locations where the company does not have a direct commercial presence. In the U.S., the company sells the majority of its products through a direct sales organization. Internationally, it sells products primarily through direct sales subsidiaries but also through independent distribution partners in certain countries. Revenue is recognized when control of the promised goods or services is transferred to the customer in an amount that reflects the consideration to which the company expects to be entitled, which includes estimates of reductions to revenue for commercial and governmental rebates owed, variable consideration for product returns and other discounts and incentives.

Glaukos operates in one operating segment and its primary business activity is the development and commercialization of therapies across several end markets within ophthalmology. The company's commercial solutions and development-stage product candidates include procedural pharmaceuticals based on an intracameral drug delivery technology designed to reduce intraocular pressure (IOP) by delivering therapeutic levels of glaucoma medication from inside the eye over an extended period of time; MIGS products that primarily involve the insertion of a micro-scale device designed to reduce IOP by restoring the natural aqueous humor outflow pathways for patients suffering from glaucoma; bio-activated pharmaceuticals that are intended to strengthen, stabilize, and reshape the cornea for patients impacted by corneal ectatic disorders such as keratoconus; transdermal pharmaceuticals that are applied to the eyelid and designed to treat demodex blepharitis, myopia and other ocular surface diseases and disorders; and proprietary micro-invasive, bio-erodible posterior sustained release drug delivery implants that are designed to elute pharmaceuticals over time to improve the vision of patients impacted by retinal diseases such as age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). For the year ended December 31, 2025, the iStent family of products, iDose TR, and related glaucoma accessories accounted for approximately 83% of net sales, while iLink therapies and associated products accounted for approximately 17% of net sales.

In December 2023, Glaukos received FDA approval for iDose TR, indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. iDose TR is a first-of-its-kind, intracameral procedural pharmaceutical therapy designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time. The company received FDA approval of its New Drug Application (NDA) for the iLink system using Epioxa therapy for the treatment of keratoconus without the removal of the epithelium in October 2025 and is preparing to commence commercial launch activities in the first half of 2026. In June 2025, Glaukos received European Union (EU) Medical Device Regulation (MDR) certification for iStent infinite, marking the company's first approval under the new EU regulatory framework, and subsequently commenced initial commercial launch activities for iStent infinite in several of its key European markets in 2025. On May 16, 2025, the company acquired all of the outstanding equity interests in Mobius Therapeutics, LLC for $12.4 million ¹, net of cash acquired, and began selling its lead product, Mitosol. On April 4, 2025, the company purchased certain real property adjacent to its existing Aliso Viejo, California corporate headquarters, consisting of land and an approximately 40,000 square foot, two-story building, for a purchase price of $16.6 million ². The company also reached agreement with the city of Huntsville, Alabama to build a brand-new 200,000 square foot R&D and manufacturing facility with construction anticipated to begin in 2026.

Net sales for the year ended December 31, 2025 were $507.4 million ³, compared to $383.5 million ⁴ in 2024, reflecting an increase of 32% ⁵. Gross margin was approximately 56% ⁶ for 2025 compared to 75% ⁷ for 2024. The company incurred a net loss of $187.7 million ⁸ for 2025, compared to a net loss of $146.4 million ⁹ for 2024. As of December 31, 2025, the company had an accumulated deficit of approximately $933.1 million ¹⁰. Cash, cash equivalents, short-term investments and restricted cash totaled $282.6 million ¹¹ as of December 31, 2025, compared to $323.6 million ¹² as of December 31, 2024.

A primary growth vector is the continued commercialization of iDose TR, which was initially launched in a controlled manner during the first quarter of 2024. Over the course of 2025, the company continued to advance its U.S. commercialization plans for iDose TR. As reimbursement for the iDose TR procedure continues to become a more timely and consistent process across all Medicare Administrative Contractors (MACs), management anticipates utilization of iDose TR by customers will increase accordingly. Another significant growth vector is the planned commercial launch of Epioxa, which received FDA approval in October 2025. The company announced plans to begin commercializing Epioxa in the first quarter of 2026. Epioxa represents an advancement in keratoconus care, offering an incision-free alternative to traditional corneal cross-linking procedures and is the first FDA-approved, incision-free, topical drug therapy that does not require removal of the corneal epithelium.

A further growth vector is the international expansion of the iStent infinite product. In June 2025, the company received EU MDR certification for iStent infinite and subsequently commenced initial commercial launch activities in several of its key European markets in 2025. The company is also advancing a robust pipeline of novel, dropless platform technologies. The current R&D pipeline includes a second-generation extended release iDose TREX Phase 2b/3 clinical program, an iDose TRIO Phase 3 clinical program, an iStent infinite PMA pivotal Phase 3 clinical trial for treatment of mild-to-moderate glaucoma, a U.S. IDE for the PRESERFLO MicroShunt, an iLink third-generation Phase 2 clinical program, a Phase 2 clinical trial for iLution Blepharitis, and an IVT Multi-Kinase Inhibitor (GLK-401) Phase 2 clinical trial for AMD, DME and RVO.

Gross margin was approximately 56% ¹³ for the year ended December 31, 2025, compared to 75% ¹⁴ for the year ended December 31, 2024. The decrease in gross margin was primarily due to a $112.9 million ¹⁵ impairment charge related to the Photrexa developed technology intangible asset recorded within cost of sales during 2025. Excluding this impairment, cost of sales increased generally proportionately to the increase in net sales, as well as contributions from increased iDose TR production and iDose TR net sales. The company expects its R&D and clinical expenditures to increase as it continues to devote significant resources to clinical trials and regulatory approvals of its pipeline products. SG&A expenses are expected to continue to grow as the company increases its infrastructure for global sales and marketing functions, commercial support organizations, and general administration departments.

The company's manufacturing operations for the iStent family of products and iDose TR are located in an approximately 120,000 square foot campus in San Clemente, California. The company's pharmaceutical therapies for keratoconus are primarily manufactured and supplied by third parties in the U.S. and Germany, and the manufacturing operations for the systems that bio-activate these therapies are located in approximately 60,000 square feet of space located in Burlington, Massachusetts. The company recently reached agreement with the city of Huntsville, Alabama to build a brand-new 200,000 square foot R&D and manufacturing facility with construction anticipated to begin in 2026. As of December 31, 2025, the company had 1,094 ¹⁶ full-time employees.

Research and development expenses were $150.6 million ¹⁷ for the year ended December 31, 2025, compared to $136.4 million ¹⁸ for the year ended December 31, 2024. The company expects R&D expenses to continue to increase as it initiates and advances its development programs. Capital expenditures were $7.7 million ¹⁹ for the year ended December 31, 2025, and the company expects levels of capital expenditures to be higher in 2026 than in 2025 in connection with the construction of the Huntsville, Alabama property, as well as expected upgrades to certain manufacturing facilities and continued investing in R&D equipment. The company has never declared or paid any cash dividends on its common stock and does not anticipate paying cash dividends in the foreseeable future.

CMS physician fee payment rate decreases, along with the finalization in late 2024 of recent Local Coverage Determinations (LCDs) issued by five of the seven MACs, have disrupted traditional customer ordering patterns and may have resulted in certain customers' utilization of competitive products, which has reduced U.S. Glaucoma sales volumes of the iStent family of products used in conjunction with cataract surgery in each of the years ended December 31, 2025, December 31, 2024 and December 31, 2023. Additionally, the royalty income received pursuant to a settlement agreement entered into during 2021 with Ivantis, Inc. relating to sales of the Hydrus Microstent contractually expired on April 26, 2025. The company's corneal health net sales have experienced sporadic headwinds in recent years due to U.S. commercial payer volatility, as well as the impact of revenue adjustments related to the company's entry into the Medicaid Drug Rebate Program (MDRP) in the first quarter of 2024. The company anticipates some potential disruption within its U.S. Corneal Health franchise as the market transitions from Photrexa to Epioxa following its approval and as it prepares for its planned controlled commercial launch in the first quarter of 2026.

The company is subject to a variety of risks associated with its international operations, which could adversely impact its results of operations and financial condition. These risks include different and sometimes more exacting and lengthy regulatory approval processes, reduced or varied protection for intellectual property rights, pricing pressure, different competitive dynamics, political and economic instability, changes or increases in duties and tariffs, and exposure to changes in foreign currencies relative to the U.S. dollar. The annual growth rate of net sales of the company's international glaucoma franchise for the year ended December 31, 2025 was positively affected by approximately 208 basis points ²⁰, primarily related to the Euro. The company also faces risks from unfavorable global and regional macroeconomic conditions, including inflation, volatility in financial and credit markets, higher interest rates and capital costs, labor shortages, increased energy costs, tariffs, and currency fluctuations.

The commercial success of iDose TR and Epioxa is dependent upon multiple factors, including physician training and adoption, establishment of consistent reimbursement, satisfactory patient outcomes, and the ability to manufacture product in volumes sufficient to meet customer demand, and failure of any one of these factors could materially impact the prospects of these products and the business. The company has incurred significant operating losses since inception and as of December 31, 2025 had an accumulated deficit of approximately $933.1 million ²¹, and there can be no assurance that it will be profitable or generate cash from operations in the future. If the supply and/or manufacture of the principal revenue-producing products, the iStent family of products, Photrexa therapies, or iDose TR, is materially disrupted, it could adversely affect the ability to manufacture products and could reduce gross margins and negatively impact operating results. Inadequate or inconsistent reimbursement for products may adversely impact the business; for example, CMS physician fee payment rate decreases and LCDs finalized by five of the seven MACs in November 2024 have disrupted traditional customer ordering patterns and may have reduced U.S. Glaucoma sales volumes of the iStent family of products. The company is subject to extensive government regulation and any failure to comply with applicable regulatory requirements could result in enforcement action, including warning letters, fines, injunctions, recalls, withdrawal of approvals, and even criminal prosecution.

Management's message emphasizes the company's focus on developing novel, dropless platform therapies and commercializing associated products for the treatment of glaucoma, corneal disorders, and retinal disease. Key themes include the continued advancement of the iDose TR commercialization, the FDA approval of Epioxa in October 2025 and plans for its controlled commercial launch in the first quarter of 2026, and the receipt of EU MDR certification for iStent infinite in June 2025 with subsequent initial commercial launch activities in key European markets. Strategic priorities emphasized for the period ahead include advancing the robust pipeline of novel platform technologies, including the iDose TREX Phase 2b/3 clinical program, the iDose TRIO Phase 3 clinical program, the iStent infinite PMA pivotal Phase 3 clinical trial, the U.S. IDE for the PRESERFLO MicroShunt, and the Phase 2 clinical trial for iLution Blepharitis. Management also highlights the acquisition of Mobius Therapeutics in May 2025 and the purchase of real property adjacent to the Aliso Viejo headquarters in April 2025, as well as the agreement with the city of Huntsville, Alabama to build a new 200,000 square foot R&D and manufacturing facility.