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GLAUKOS Corp

For the period ended Sep 30, 2025. Filed Oct 31, 2025.

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About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Oct 31, 2025

GKOS$224.41+2.0%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-04.

0001558370-25-010113

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-10-31.

0001104659-25-104529

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 140 previous paragraphs and 139 current paragraphs.

71 unchanged; 55 reworded; 9 added; 11 removed; 3 previous and 4 current paragraphs rearranged.

Tables are not compared: 7 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (9)

Current report

On October 20, 2025, we announced U.S. FDA approval forEpioxa indicated for the treatment of keratoconus.Epioxa represents an advancement in keratoconus care, offering an incision-free alternative to traditional corneal cross-linking procedures.Epioxa is the first FDA-approved, incision-free, topical drug therapy that does not require removal of the corneal epithelium and is designed to eliminate the pain associated with epithelium removal, streamline the procedure, and minimize recovery. We announced plans to begin commercializing Epioxa in the first quarter of 2026.

Current report

impact the ability of the FDA to timely review and process our regulatory submissions or negatively affect sales of our products. We will continue to evaluate the impacts of tariffs and government shutdowns on our business and results of operations.

Current report

Now thatEpioxa, our new CXL procedure, has been approved by the U.S. FDA, reimbursement will mostly involve updates to third-party commercial insurance policies as the vast majority of patients who are diagnosed with, and then treated for, keratoconus are below the Medicare age. Therefore, the procedural component ofEpioxawill be covered by a temporary Category III CPT code, 0402T. Next, we will apply for a permanent HCPCS J-Code forEpioxa and we will seek coverage by third-party commercial payers. The professional fees associated with the CXL procedure will be determined by each payer. Coverage and reimbursement can differ significantly from payer to payer, and payers can change or deny coverage for new or existing products without notice.

Current report

SG&A expenses for the three months ended September 30, 2025 and September 30, 2024 were $83.0 million and $64.0 million, respectively, reflecting an increase of $19.0 million or 30%.

Current report

R&D expenses for the three months ended September 30, 2025 and September 30, 2024 were $38.1 million and $34.7 million, respectively, reflecting an increase of $3.3 million or 10%.

Current report

Comparison of Nine Months Ended September 30, 2025 and September 30, 2024 (in thousands):

Current report

SG&A expenses for the nine months ended September 30, 2025 and September 30, 2024 were $237.0 million and $192.2 million, respectively.

Current report

R&D expenses for the nine months ended September 30, 2025 and September 30, 2024 were $107.0 million and $99.9 million, respectively.
Removed paragraphs (11)

Previous report

In addition to the foregoing, we commercialized certain of our products for several years in the U.S. with few or no direct competitors. Other competitive products have now become available in the U.S. and globally that have impacted and are expected to continue to impact adoption of or demand for our products. We are also aware of similar products being developed by third parties that could enter the market and increase the competitive pressures we face. These other products could achieve greater commercial acceptance or demonstrate better safety or effectiveness, clinical results, ease of use or lower costs than our products, which could adversely impact our net sales.

Previous report

We manufacture ouriStent family of products andiDose TR at our facilities in San Clemente, California and our KXL systems at our manufacturing facility in Burlington, Massachusetts. We contract with third-party

Previous report

manufacturers in the U.S. and Germany to produce ourPhotrexa and other associated drug formulations. We currently intend to maintain our manufacturing facilities at our San Clemente and Burlington locations for the foreseeable future.

Previous report

SG&A expenses for the three months ended June 30, 2025 and June 30, 2024 were $83.4 million and $66.2 million, respectively, reflecting an increase of $17.2 million or 26%.

Previous report

R&D expenses for the three months ended June 30, 2025 and June 30, 2024 were $36.5 million and $34.4 million, respectively, reflecting an increase of $2.1 million or 6%.

Previous report

In the quarter ended June 30, 2024 we made a $2.5 million upfront payment to enter into a license agreement with a third-party technology company, pursuant to which we obtained an exclusive, worldwide license to develop and commercialize drug products incorporating certain proprietary technology. There were no acquired IPR&D expenses in the three months ended June 30, 2025.

Previous report

Comparison of Six Months Ended June 30, 2025 and June 30, 2024 (in thousands):

Previous report

SG&A expenses for the six months ended June 30, 2025 and June 30, 2024 were $154.0 million and $128.2 million, respectively.

Previous report

R&D expenses for the six months ended June 30, 2025 and June 30, 2024 were $68.9 million and $65.2 million, respectively.
Reworded paragraphs (55)

Previous wording

We incurred net losses for the three and six months ended June 30, 2025 of $19.7 million and $37.8 million, respectively, and incurred net losses of $50.5 million and $91.4 million for the three and six months ended June 30, 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $783.2 million.

Current wording

We incurred net losses for the three and nine months ended September 30, 2025 of $16.2 million and $54.0 million, respectively, and incurred net losses of $21.4 million and $112.8 million for the three and nine months ended September 30, 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $799.5 million.

Previous wording

In June 2025, we received European Union (EU) Medical Device Regulation (MDR) certification for ouriStent family of products, including theiStent infinite and theiStent inject W. We also received certification for ouriStent products under the United Kingdom’s Medical Device Regulation. We expect to commence commercial launch activities in our key EU markets in the second half of 2025.

Current wording

In June 2025, we received European Union (EU) Medical Device Regulation (MDR) certification for ouriStent family of products, including theiStent infinite and theiStent inject W. We also received certification for ouriStent products under the United Kingdom’s Medical Device Regulation. We commenced some commercial launch activities in certain of our key EU markets in the third quarter of 2025.

Previous wording

On May 16, 2025, pursuant to a definitive agreement and plan of merger (Mobius Agreement), the Company acquired all of the outstanding equity interests in Mobius Therapeutics, LLC (Mobius) for $12.4 million, net of cash acquired (Mobius Merger). Pursuant to the Mobius Agreement, we also agreed to pay the former Mobius equityholders contingent consideration in the form of single-digit royalty payments based on net sales of Mobius products for a period of four years, and additional performance-based payments of up to $80.0 million in aggregate upon the achievement of certain net sales milestones with respect to such Mobius products. Mobius’ lead product,Mitosol, is the only FDA-approved ophthalmic formulation of mitomycin-C, which is often utilized as an adjunct in late-stage glaucoma filtration procedures.

Current wording

On May 16, 2025, pursuant to a definitive agreement and plan of merger (Mobius Agreement), we acquired all of the outstanding equity interests in Mobius Therapeutics, LLC (Mobius) for $12.4 million, net of cash acquired (Mobius Merger). Pursuant to the Mobius Agreement, we also agreed to pay the former Mobius equityholders contingent consideration in the form of single-digit royalty payments based on net sales of Mobius products for a period of four years, and additional performance-based payments of up to $80.0 million in aggregate upon the achievement of certain net sales milestones with respect to such Mobius products. Mobius’ lead product,Mitosol, is the only FDA-approved ophthalmic formulation of mitomycin-C, which is often utilized as an adjunct in late-stage glaucoma filtration procedures.

Previous wording

On April 4, 2025, we purchased certain real property consisting of an approximately 40,000 square foot, two-story building, located in Aliso Viejo, California (Aliso Building) and adjacent to our existing Aliso Viejo, California corporate headquarters (Aliso Facility). We paid a purchase price of $16.6 million for the Aliso Building, which is currently occupied by several tenants whose leases, which were assumed by the Company, run through 2029. The Aliso Building provides us with future expansion opportunities and potentially reduces future capital expenditures associated with construction of an additional building as part of the Aliso Facility.

Current wording

On April 4, 2025, we purchased certain real property consisting of an approximately 40,000 square foot, two-story building, located in Aliso Viejo, California (Aliso Building) and adjacent to our existing Aliso Viejo, California corporate headquarters (Aliso Facility). We paid a purchase price of $16.6 million for the Aliso Building, which is currently occupied by several tenants whose leases, which were assumed by us, run through 2029. The Aliso Building provides us with future expansion opportunities and potentially reduces future capital expenditures associated with construction of an additional building as part of the Aliso Facility.

Previous wording

During the last twelve months, global and regional economies have experienced, in connection with ongoing macroeconomic conditions, inflation, supply shortages or delays, changes in supply and demand, foreign exchange rate fluctuations, new or increased tariffs, and other conditions that have led to disruptions in commerce and pricing stability. Additionally, some of our vendors are continuing to experience supply challenges, both in the acquisition of raw materials as well as due to labor shortages and other disruptions. These challenges have occasionally led to longer lead times and delays of certain components needed for the manufacture of our products, in some cases requiring us to find alternative sources for materials. As a result of these supply chain challenges and ongoing inflationary pressures, we have experienced higher costs for certain components and raw materials. While these supply challenges have generally stabilized over the course of 2024, if these supply issues persist or worsen in the future, they could impact our gross margins, our ability to ship some of our products to our customers, or bring some of our pipeline products to market, in a timely manner. We expect some supply challenges and higher costs of certain components and raw materials to continue throughout 2025. The U.S. government recently announced tariffs on product imports from certain countries, including higher tariffs levels on those imported from Canada, Mexico and China. These actions have resulted, and are expected to further result, in retaliatory measures on U.S. goods by those countries and others. While we believe our exposure to these tariffs and the potential escalation of trade disputes is limited as we primarily source our raw materials and product components from the U.S., these tariffs, or the introduction of new or higher tariffs in other countries, could pose a risk to our business, or the businesses of our customers, that could affect our net sales and cost of sourcing materials. We will continue to evaluate the impacts of tariffs on our business and results of operations.

Current wording

As a result of the ongoing macroeconomic conditions, global and regional economies have continued to experience varying levels of inflation, supply shortages or delays, changes in supply and demand, foreign exchange rate fluctuations, new or increased tariffs, and other conditions that have led to disruptions in commerce and pricing stability. Additionally, some of our vendors are continuing to experience supply challenges, both in the acquisition of raw materials as well as due to labor shortages and other disruptions. These challenges have occasionally led to longer lead times and delays of certain components needed for the manufacture of our products, in some cases requiring us to find alternative sources for materials. As a result of these supply chain challenges and ongoing inflationary pressures, we have experienced higher costs for certain components and raw materials. While these supply challenges have generally stabilized over the course of 2025, if these supply issues persist or worsen in the future, they could impact our gross margins, our ability to ship some of our products to our customers, or bring some of our pipeline products to market, in a timely manner.

Previous wording

The effects of foreign currency fluctuations are most notably experienced in our international glaucoma business. Our annual growth rate of net sales of our international glaucoma franchise for the three and six months ended June 30, 2025 were positively affected by approximately 410 and 25 basis points, respectively, primarily related to the Euro and Japanese yen. For the three and six months ended June 30, 2024, net sales of our international glaucoma business were negatively impacted by approximately 390 and 290 basis points, respectively, primarily related to the Japanese Yen.

Current wording

The effects of foreign currency fluctuations are most notably experienced in our international glaucoma business. Our annual growth rate of net sales of our international glaucoma franchise for the three and nine months ended September 30, 2025 were positively affected by approximately 330 and 120 basis points, respectively, primarily related to the Euro and Japanese yen. For the three and nine months ended September 30, 2024, net sales of our international glaucoma business were negatively impacted by approximately 20 and 210 basis points, respectively, primarily related to the Japanese Yen.

Previous wording

In the U.S., healthcare providers use separate billing codes to report the provision of medical procedures and use of supplies to third-party payors, such as government programs or private insurance, and seek reimbursement for all or a portion of those costs. Physician fee payment rates for procedures covered by temporary Current Procedural Terminology (CPT) codes, such as a standalone trabecular micro-bypass procedure utilizing theiStent infinite, along with the procedural component ofiDose TR, are set by the multi-state, regional contractors, or Medicare Administrative Contractors (MACs), of which there are currently seven, that are responsible for administering Medicare claims. MACs have in the past, and may in the future, change coverage terms, and there can be no assurance that coverage and adequate reimbursement will be obtained from, or maintained by, the MACs.

Current wording

In the U.S., healthcare providers use separate billing codes to report the provision of medical procedures and use of supplies to third-party payors, such as government programs or private insurance, and seek reimbursement for all or a portion of those costs. Physician fee payment rates for procedures covered by temporary Current Procedural Terminology (CPT) codes in the Medicare Fee for Service setting, such as a standalone trabecular micro-bypass procedure utilizing theiStent infinite, along with the procedural component ofiDose TR, are set by the multi-state, regional contractors, or Medicare Administrative Contractors (MACs), of which there are currently seven, that are responsible for administering Medicare claims. MACs have in the past, and may in the future, change coverage terms, and there can be no assurance that coverage and adequate reimbursement will be obtained from, or maintained by, the MACs.

Previous wording

The unique, permanent Healthcare Common Procedure Coding System J-code foriDose TR, indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension, J7355, became effective July 1, 2024. J-codes are used by U.S. government and commercial payers, to streamline the billing and reimbursement process for procedural pharmaceuticals administered by a healthcare professional, such asiDose TR.In addition to the J-code, on March 21, 2024, CMS assigned the temporary CPT codes that are designed to be used to cover the procedural component ofiDose TR, 0660T and 0661T, to ambulatory payment classification 5492 (Level 2 Intraocular Procedures), retroactively effective as of January 1, 2024. As of June 30, 2025, the professional fees associated with aniDose TR procedure have been published by three of the seven MACs.

Current wording

The unique, permanent Healthcare Common Procedure Coding System (HCPSC) J-code foriDose TR, indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension, J7355, became effective July 1, 2024. J-codes are used by U.S. government and commercial payers, to streamline the billing and reimbursement process for procedural pharmaceuticals administered by a healthcare professional, such asiDose TR.In addition to the J-code, on March 21, 2024, CMS assigned the temporary CPT codes that are designed to be used to cover the procedural component ofiDose TR, 0660T and 0661T, to ambulatory payment classification 5492 (Level 2 Intraocular Procedures), retroactively effective as of January 1, 2024. As of September 30, 2025, the professional fees associated with aniDose TR procedure have been published by four of the seven MACs.

Previous wording

On July 14, 2025 and July 15, 2025, the U.S. Centers for Medicare & Medicaid Services’ (CMS’) published its proposed rules on 2026 Medicare physician fee and facility fee payment rates (2026 Proposed Rules), respectively. The 2026 Proposed Rules reflected a modest increase with respect to facility fee payment rates in both the ASC and hospital outpatient setting over the 2025 Medicare facility fee payment rates with respect to procedures using our glaucoma products. The 2026 Proposed Rule also reflected reductions with respect to physician fee payment rates over the 2025 Medicare physician payment rates with respect to several Category I CPT codes across ophthalmology, including for cataract and surgical MIGS procedures specifically. The physician fee rules contained in the 2026 Proposed Rules do not affect the physician fees paid under temporary CPT codes foriDose TR andiStent infinite, because as explained above, those rates are determined on a MAC-by-MAC basis.

Current wording

products. The 2026 Proposed Rule also reflected reductions with respect to physician fee payment rates over the 2025 Medicare physician payment rates with respect to several Category I CPT codes across ophthalmology, including for cataract and surgical MIGS procedures specifically. The physician fee rules contained in the 2026 Proposed Rules do not affect the physician fees paid under temporary CPT codes foriDose TR andiStent infinite, because as explained above, those rates are determined on a MAC-by-MAC basis.

Previous wording

CMS physician fee payment rate decreases, along with the finalization in late 2024 of recent LCDs issued by five of the seven MACs, have disrupted traditional customer ordering patterns and may have resulted in certain of our customers’ utilization of competitive products, which has reduced U.S. Glaucoma sales volumes of ouriStent family of products used in conjunction with cataract surgery in each of the three and six months ended June 30, 2025 and June

Current wording

CMS physician fee payment rate decreases, along with the finalization in late 2024 of recent LCDs issued by five of the seven MACs, have disrupted traditional customer ordering patterns and may have resulted in certain of our customers’ utilization of competitive products, which has reduced U.S. Glaucoma sales volumes of ouriStent family of products used in conjunction with cataract surgery in each of the three and nine months ended September 30, 2025 and September 30, 2024. Additionally, the royalty income we received pursuant to a settlement agreement entered into during 2021 with Ivantis, Inc. (acquired by Alcon in 2022) relating to sales of the Hydrus® Microstent contractually expired on April 26, 2025.

Previous wording

The FDA has established a Prescription Drug User Fee Act date, more commonly known as an FDA approval decision date (PDUFA date), of October 20, 2025 for our next iLink product, Epioxa. The potential approval of Epioxa would provide keratoconus patients and the ophthalmic community with the first FDA-approved, surgery free, topical drug therapy catalyzed by oxygen and light that does not require the removal of the corneal epithelium, the outermost layer of the front of the eye. Because Epioxa is designed to preserve the corneal epithelium, streamline the procedure, improve patient comfort and shorten recovery time, we anticipate some potential disruption within our U.S. Corneal Health franchise as the market transitions from Photrexa to Epioxa following its potential approval.

Current wording

The approval ofEpioxa provides keratoconus patients and the ophthalmic community with the first FDA-approved, surgery free, topical drug therapy catalyzed by oxygen and light that does not require the removal of the corneal epithelium, the outermost layer of the front of the eye. BecauseEpioxa is designed to preserve the corneal epithelium, streamline the procedure, improve patient comfort and shorten recovery time, we anticipate some potential disruption within our U.S. Corneal Health franchise as the market transitions fromPhotrexa toEpioxa following its approval and as we prepare for our planned controlled commercial launch in the first quarter of 2026.

Previous wording

Additionally, we have received a PDUFA date in January 2026 relating to our supplemental new drug application (NDA) filed with the FDA for the re-administration ofiDose TR to patients who have previously received aniDose TR implant. There can be no assurance that we will receive approval of this supplemental NDA.

Current wording

Additionally, we have received a Prescription Drug User Fee Act (PDUFA) date of January 2026 relating to our supplemental new drug application (NDA) filed with the FDA for the re-administration ofiDose TR to patients who have previously received aniDose TR implant. There can be no assurance that we will receive approval of this supplemental NDA.

Previous wording

Our net sales are generated primarily from sales of ouriStent family of products,iDose TR,Photrexa and other associated drug formulations, and our proprietary bioactivation systems. Customers are primarily comprised of ambulatory surgery centers, hospitals, and physician private practices, with independent distributors being used in certain international locations where we currently do not have a direct commercial presence. We currently operate in one operating and reportable segment and our primary business activity is the development and commercialization of therapies across several end markets within ophthalmology.

Current wording

Our net sales are generated primarily from sales ofiDose TR, ouriStent family of products,Photrexa and other associated drug formulations, and our proprietary bioactivation systems. Customers are primarily comprised of ambulatory surgery centers, hospitals, and physician private practices, with independent distributors being used in certain international locations where we currently do not have a direct commercial presence. We currently operate in one operating and reportable segment and our primary business activity is the development and commercialization of therapies across several end markets within ophthalmology.

Previous wording

We sell the majority of our products through a direct sales organization in the United States. Internationally, we sell our products primarily through direct sales subsidiaries and through independent distributors in certain countries in which we do not have a direct presence or maintain a modest commercial presence. The primary end-user customers for our products are surgery centers, hospitals and physician private practices.

Current wording

We sell the majority of our products through a direct sales organization in the United States. Internationally, we sell our products primarily through direct sales subsidiaries and through independent distributors in certain countries

Previous wording

Cost of sales includes amortization of the $252.2 million and $17.8 million developed technology intangible assets recorded as a result of our acquisitions of Avedro, Inc. (Avedro) and Mobius, respectively, and our sales agreement with Celanese Canada ULC (Celanese Agreement). For the three months ended June 30, 2025 and June 30, 2024, the amortization expense was $5.8 million and $5.5 million, respectively, and for the six months ended June 30, 2025 and June 30, 2024, amortization expense was $11.4 million and $11.1 million, respectively.

Current wording

Cost of sales includes amortization of the $252.2 million and $17.8 million developed technology intangible assets recorded as a result of our acquisitions of Avedro, Inc. (Avedro) and Mobius, respectively, and our sales agreement with Celanese Canada ULC (Celanese Agreement). For the three months ended September 30, 2025 and September 30, 2024, the amortization expense was $6.1 million and $5.5 million, respectively, and for the nine months ended September 30, 2025 and September 30, 2024, amortization expense was $17.5 million and $16.6 million, respectively.

Previous wording

Our future gross profit as a percentage of net sales, or gross margin, will be impacted by numerous factors including commencement of sales of new products currently in our pipeline, or any other future products, which may have higher pricing, or conversely, higher product costs. Our gross margin will also be affected by manufacturing or supply chain costs, disruptions or inefficiencies that we may experience as we attempt to manufacture our products on a larger scale, manufacture new products and change our manufacturing capacity, processes, or output. Additionally, our gross margin will continue to be affected by amortization of Avedro developed technology and Celanese Agreement intangible assets, the impact of rebates and allowances associated with government and commercial programs and by royalty expenses on current or future products associated with various licensing agreements. Our gross margin in future periods may also be impacted by other factors adversely affecting our net sales in future periods such as the impact of government pricing programs and reductions of payment rates for certain of our products and related services, and inflationary pressures.

Current wording

Our future gross profit as a percentage of net sales, or gross margin, will be impacted by numerous factors including commencement of sales of new products currently in our pipeline, or any other future products, which may have higher pricing, or conversely, higher product costs. Our gross margin will also be affected by manufacturing or supply chain costs, disruptions or inefficiencies that we may experience as we attempt to manufacture our products on a larger scale, manufacture new products and change our manufacturing capacity, processes, or output. Additionally, our gross margin will continue to be affected by amortization of Avedro and Mobius developed technology and Celanese Agreement intangible assets, the impact of rebates and allowances associated with government and commercial programs and by royalty expenses on current or future products associated with various licensing agreements. Our gross margin in future periods may also be impacted by other factors adversely affecting our net sales in future periods such as the impact of government pricing programs and reductions of payment rates for certain of our products and related services, and inflationary pressures.

Previous wording

SG&A expenses also included amortization of the $14.1 million and $0.5 million customer relationships intangible assets recorded as a result of our acquisitions of Avedro, Inc. (Avedro) and Mobius, respectively. During the three months ended June 30, 2025, amortization expense was less than $0.1 million related to the Mobius customer relationships intangible asset. The Avedro intangible asset was fully amortized as of December 31, 2024. Amortization expense was $0.7 million and $1.4 million for the three and six months ended June 30, 2024.

Current wording

SG&A expenses also included amortization of the $14.1 million and $0.4 million customer relationships intangible assets recorded as a result of our acquisitions of Avedro, Inc. (Avedro) and Mobius, respectively, as well as the $0.7 million in-place lease intangible asset from the Aliso Building acquisition. During the three months ended September 30, 2025, amortization expense was $0.3 million. The Avedro intangible asset was fully amortized as of December 31, 2024, and such amortization expense was $0.7 million and $2.1 million for the three and nine months ended September 30, 2024.

Previous wording

We expect SG&A expenses to continue to grow as we increase our infrastructure for our global sales and marketing functions, commercial support organizations, and general administration departments. We also expect other non-employee-related costs, including sales and marketing program activities for new products, market access efforts, outside services, accounting services and general legal costs to increase as our overall operations grow. The timing of these increased expenditures and their magnitude are primarily dependent on the commercial success and sales growth of our products, as well as on the timing of any new product launches and other potential business and operational activities.

Current wording

We expect SG&A expenses to continue to grow as we increase our infrastructure for our global sales and marketing functions, commercial support organizations, and general administration departments. We also expect other non-employee-related costs, including sales and marketing program activities for new products, market access efforts, outside services, accounting services and general legal costs to increase as our overall operations grow. The timing of

Previous wording

Our research and development (R&D) activities primarily consist of new product development projects, pre-clinical studies, Investigational New Drug studies, and clinical trials. Our R&D expenses primarily consist of personnel-related expenses, including salaries, fringe benefits and stock-based compensation for our R&D employees; research materials; supplies and services; in-licenses, including event-based milestones; and the costs of conducting clinical studies, which include payments to investigational sites and investigators, clinical research organizations, consultants, and other outside technical services; and the costs of materials, supplies and travel. We expense R&D costs as they are incurred. We expect our R&D expenses to continue to increase as we initiate and advance our development

Current wording

Our research and development (R&D) activities primarily consist of new product development projects, pre-clinical studies, Investigational New Drug studies, and clinical trials. Our R&D expenses primarily consist of personnel-related expenses, including salaries, fringe benefits and stock-based compensation for our R&D employees; research materials; supplies and services; in-licenses, including event-based milestones; and the costs of conducting clinical studies, which include payments to investigational sites and investigators, clinical research organizations, consultants, and other outside technical services; and the costs of materials, supplies and travel. We expense R&D costs as they are incurred. We expect our R&D expenses to continue to increase as we initiate and advance our development programs, including our expanding pharmaceutical development efforts and clinical trials across the glaucoma, corneal health and retinal disease spectrums.

Previous wording

Net sales for the three months ended June 30, 2025 and June 30, 2024 were $124.1 million and $95.7 million, respectively, increasing by approximately 30% primarily related to the factors listed below.

Current wording

Net sales for the three months ended September 30, 2025 and September 30, 2024 were $133.5 million and $96.7 million, respectively, increasing by approximately 38% primarily related to the factors listed below.

Previous wording

Net sales of glaucoma products in the United States were $72.3 million and $49.8 million for the three months ended June 30, 2025 and June 30, 2024, respectively, increasing by 45%. This increase is primarily due to higher volume of sales of* iDose TR*, partially offset by lower volumes sold of our* iStent* family of products primarily due to the MIGS restrictions associated with the final LCDs issued by the five MACs as described above in theMarket and Business Update section.

Current wording

Net sales of glaucoma products in the United States were $80.8 million and $51.6 million for the three months ended September 30, 2025 and September 30, 2024, respectively, increasing by 57%. This increase is primarily due to higher volume of sales of* iDose TR*, which has a higher net sales price than our other products, partially offset by lower volumes sold of our* iStent* family of products primarily due to the MIGS restrictions associated with the final LCDs issued by the five MACs as described above in theMarket and Business Update section.

Previous wording

International sales of glaucoma products for the three months ended June 30, 2025 and June 30, 2024 were $31.3 million and $26.1 million, respectively, increasing by 20%. The increase in international sales reflects continued broad-based growing volume in many key international markets for glaucoma procedures, primarily Japan, France, the United Kingdom and Germany, the dollar-based results of which were affected by favorable foreign exchange rates, primarily related to the Euro and Japanese Yen, during the quarter ended June 30, 2025, as compared to the three months ended June 30, 2024.

Current wording

International sales of glaucoma products for the three months ended September 30, 2025 and September 30, 2024 were $29.4 million and $24.5 million, respectively, increasing by 20%. The increase in international sales reflects continued broad-based growing volume in many key international markets for glaucoma procedures, primarily the United Kingdom, Japan, France, and Germany, the dollar-based results of which were modestly affected by favorable foreign exchange rates, primarily related to the Euro and Japanese Yen, during the three months ended September 30, 2025, as compared to the three months ended September 30, 2024.

Previous wording

Net sales of corneal health products were $20.6 million and $19.8 million for the three months ended June 30, 2025 and June 30, 2024, respectively, increasing by 4%. Within net sales generated by our corneal health products, $1.1 million related to an increase in U.S. net sales of Photrexa using direct sales operations, which was positively impacted by higher realized average sales prices of Photrexa along with slight increases in sales to existing customers and new account starts, partially offset by accrued rebates related to the impact of our participation in MDRP. Our net sales ofiLink devices in the U.S. remained consistent for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024. Our international corneal health sales decreased $0.4 million during the quarter ended June 30, 2025 as compared to the three months ended June 30, 2024.

Current wording

Net sales of corneal health products were $23.3 million and $20.6 million for the three months ended September 30, 2025 and September 30, 2024, respectively, increasing by 13%. Of the $2.7 million increase in net sales generated by our corneal health products, $2.4 million related to U.S. net sales of Photrexa using direct sales operations, which was positively impacted by higher realized average sales prices of Photrexa along with slight increases in sales to existing customers and new account starts, partially offset by accrued rebates related to the impact of our participation in MDRP. Our net sales ofiLink devices in the U.S. remained consistent for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024. Our international corneal health sales increased $0.5 million during the three months ended September 30, 2025 as compared to the three months ended September 30, 2024.

Previous wording

Cost of sales for the three months ended June 30, 2025 and June 30, 2024 were $26.9 million and $22.6 million, respectively, reflecting an increase of approximately $4.3 million that is generally proportionate to the increase in net sales for the corresponding period, as well as from contributions from increasediDose TR production volumes. Our gross margin was 78% for three months ended June 30, 2025 and 76% for the three months ended June 30, 2024.

Current wording

Cost of sales for the three months ended September 30, 2025 and September 30, 2024 were $28.8 million and $22.6 million, respectively, reflecting an increase of approximately $6.2 million that is generally proportionate to the increase in net sales for the corresponding period, as well as from contributions from increasediDose TR production volumes andiDose TR net sales. Our gross margin was 78% for three months ended September 30, 2025 and 77% for the three months ended September 30, 2024.

Previous wording

Of the total $17.2 million increase in SG&A expenses for the three months ended June 30, 2025 as compared to the three months ended June 30, 2024, $7.1 million related to increased compensation and related employee costs, with $5.5 million of the incremental amount related to an increase in stock-based compensation expense, the majority of which was associated with certain performance equity awards that were achieved during the quarter. The residual increase primarily relates to enhancements of various customer and patient support functions, our business intelligence function, and growth in our commercial infrastructure in glaucoma and corneal health, along with increased travel, meetings and accompanying costs as business activities have expanded.

Current wording

Of the total $19.0 million increase in SG&A expenses for the three months ended September 30, 2025 as compared to the three months ended September 30, 2024, $4.1 million related to increased compensation and related employee costs, the majority of which was associated with stock-based compensation related to certain performance equity awards that were achieved during the quarter. The residual increase primarily relates to enhancements of various customer and patient support functions, our business intelligence function, and growth in our commercial infrastructure in glaucoma and corneal health, along with increased travel, meetings and accompanying costs as business activities have expanded.

Previous wording

The remaining increase of $12.9 million primarily relates to discretionary expenses supporting the above personnel growth as well as our ongoing administrative operations, inclusive of information technology, facilities and allocated expenses.

Current wording

The remaining increase of $14.6 million primarily relates to discretionary expenses supporting the above personnel growth as well as our ongoing administrative operations, inclusive of information technology, facilities, and allocated expenses; as well as reserves for accounts receivable, which are objectively calculated based on our accounts receivable reserve methodology.

Previous wording

During the three months ended June 30, 2025, we incurred $25.8 million in core R&D expenses and $10.7 million in clinical expenses, comprised of $23.6 million in compensation and related employee expenses with the remaining $12.9 million spent on the continued research and development, clinical studies, regulatory activities, quality assurance, clinical inventory and supplies for surgical glaucoma product candidates and pharmaceutical projects, such as next generationiDoseproducts*;* Epioxa, a pharmaceutical therapeutic system for the treatment of keratoconus without the removal of the epithelium (also referred to as “epi-on”); and our earlier stage programs for* *glaucoma, corneal, retinal and other therapeutic investments. For the three months ended June 30, 2024, we incurred $19.8 million in core R&D expenses and $14.6 million in clinical expenses, comprised of $21.4 million in compensation and related employee expenses with the remaining $13.4 million spent on the above-mentioned programs.

Current wording

During the three months ended September 30, 2025, we incurred $26.9 million in core R&D expenses and $11.2 million in clinical expenses, comprised of $22.3 million in compensation and related employee expenses with the remaining $15.5 million spent on the continued research and development, clinical studies, regulatory activities, quality assurance, clinical inventory and supplies for surgical glaucoma product candidates and pharmaceutical projects, such as next generationiDoseproducts*;* Epioxa; and our earlier stage programs for* *glaucoma, corneal, retinal and other therapeutic investments. For the three months ended September 30, 2024, we incurred $22.3 million in core R&D expenses and $12.4 million in clinical expenses, comprised of $20.4 million in compensation and related employee expenses with the remaining $14.3 million spent on the above-mentioned programs.

Previous wording

We had non-operating income, net of $3.3 million and non-operating expense, net of $20.2 million for the three months ended June 30, 2025 and June 30, 2024, respectively. The change primarily relates to a decrease of $18.0 million of expense related to the exchange of our Convertible Notes in June 2024, a decrease of $2.2 million in interest expense on our Convertible Notes, and a change in unrealized foreign currency amounts recognized of approximately $3.6 million due to intercompany loan balances denominated in, and impacted by, changes in foreign currency exchange rates, as compared to the three months ended June 30, 2024.

Current wording

We had non-operating income, net of $0.4 million and $3.4 million for the three months ended September 30, 2025 and September 30, 2024, respectively. The change primarily relates to a change in unrealized foreign currency amounts recognized of approximately $4.2 million due to intercompany loan balances denominated in, and impacted by, changes in foreign currency exchange rates, as compared to the three months ended September 30, 2024, partially offset by a decrease of $0.5 million in interest expense on our Convertible Notes.

Previous wording

Our effective tax rate for the second quarter of 2025 and 2024 was (1.28)% and (0.66)%, respectively. For the three months ended June 30, 2025 and June 30, 2024, we recorded a provision for income taxes of $0.2 million and $0.3 million, respectively, which were primarily comprised of state and foreign income tax expense, offset by release of uncertain tax positions for which the statute of limitations has expired.

Current wording

Our effective tax rate for the third quarter of 2025 and 2024 was (1.46)% and (0.83)%, respectively. For each of the three months ended September 30, 2025 and September 30, 2024, we recorded a provision for income taxes of $0.2 million which was primarily comprised of state and foreign income tax expense, offset by release of uncertain tax positions for which the statute of limitations has expired.

Previous wording

Net sales for the six months ended June 30, 2025 and June 30, 2024 were $230.8 million and $181.3 million, respectively, increasing by approximately 27% primarily related to the factors listed below.

Current wording

Net sales for the nine months ended September 30, 2025 and September 30, 2024 were $364.3 million and $278.0 million, respectively, increasing by approximately 31% primarily related to the factors listed below.

Previous wording

Net sales of glaucoma products in the United States were $131.4 million and $91.7 million for the six months ended June 30, 2025 and June 30, 2024, respectively, increasing by 43%. This increase is primarily due to higher volumes sold ofiDose TR, partially offset by lower volumes sold of our* iStent* family of products primarily due to the MIGS restrictions associated with the final LCDs issued by the five MACs as described above in theMarket and Business Update section.

Current wording

Net sales of glaucoma products in the United States were $212.2 million and $143.3 million for the nine months ended September 30, 2025 and September 30, 2024, respectively, increasing by 48%. This increase is primarily due to higher volumes sold ofiDose TR, which has a higher net sales price than our other products, partially offset by lower volumes sold of our* iStent* family of products primarily due to the MIGS restrictions associated with the final LCDs issued by the five MACs as described above in theMarket and Business Update section.

Previous wording

International sales of glaucoma products for the six months ended June 30, 2025 and June 30, 2024 were $60.3 million and $51.4 million, respectively, increasing by 17%. The increase in international sales reflects continued broad-based growing volume in many key international markets for glaucoma procedures, most notably from France, Japan, and the United Kingdom, the dollar-based results of which were modestly affected by favorable foreign exchange rates, primarily related to the Euro and Japanese Yen, during the six months ended June 30, 2025, as compared to the six months ended June 30, 2024.

Current wording

International sales of glaucoma products for the nine months ended September 30, 2025 and September 30, 2024 were $89.7 million and $75.8 million, respectively, increasing by 18%. The increase in international sales reflects continued broad-based growing volume in many key international markets for glaucoma procedures, most notably from France, Japan, and the United Kingdom, the dollar-based results of which were modestly affected by favorable foreign exchange rates, primarily related to the Euro and Japanese Yen, during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024.

Previous wording

Net sales of corneal health products were $39.1 million and $38.2 million for the six months ended June 30, 2025 and June 30, 2024, respectively, increasing by 2%. Of the $0.9 million increase in net sales generated by our corneal health products, $1.4 million related to an increase in U.S. net sales of Photrexa using direct sales operations, which was positively impacted by higher realized average sales prices of Photrexa along with increases in sales to existing customers and new account starts, partially offset by accrued rebates related to the impact of our participation in the MDRP. Our international corneal health sales decreased $0.5 million during the six months ended June 30, 2025 as compared to the six months ended June 30, 2024.

Current wording

Net sales of corneal health products were $62.4 million and $58.8 million for the nine months ended September 30, 2025 and September 30, 2024, respectively, increasing by 6%. Of the $3.6 million increase in net sales generated by our corneal health products, $3.8 million related to an increase in U.S. net sales of Photrexa using direct sales operations, which was positively impacted by higher realized average sales prices of Photrexa along with increases in sales to existing customers and new account starts, partially offset by accrued rebates related to the impact of our participation in the MDRP. Our sales ofiLink devices decreased $0.2 million during the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024.

Previous wording

Cost of sales for the six months ended June 30, 2025 and June 30, 2024 were $51.2 million and $42.8 million, respectively, reflecting an increase of approximately $8.4 million that is proportionate to the increase in net sales for the corresponding period, as well as from contributions from increasediDose TR production volumes. Our gross margin was 78% and 76% for the six months ended June 30, 2025 and June 30, 2024, respectively.

Current wording

Cost of sales for the nine months ended September 30, 2025 and September 30, 2024 were $80.0 million and $65.4 million, respectively, reflecting an increase of approximately $14.7 million that is proportionate to the increase in net sales for the corresponding period, as well as from contributions from increasediDose TR production volumes. Our gross margin was 78% and 76% for the nine months ended September 30, 2025 and September 30, 2024, respectively.

Previous wording

Of the total $25.9 million increase in SG&A expenses for the six months ended June 30, 2025 as compared to the six months ended June 30, 2024, $13.0 million related to increased compensation and related employee costs, with $7.0 million of the incremental amount related to an increase in stock-based compensation expense. This increase primarily relates to enhancements of various customer and patient support functions, our business intelligence function, and growth in our commercial infrastructure in glaucoma and corneal health, along with increased travel, meetings and accompanying costs as business activities have expanded.

Current wording

Of the total $44.9 million increase in SG&A expenses for the nine months ended September 30, 2025 as compared to the nine months ended September 30, 2024, $17.1 million related to increased compensation and related employee costs, with $6.0 million of the incremental amount related to an increase in stock-based compensation expense. This increase primarily relates to enhancements of various customer and patient support functions, our business intelligence function, and growth in our commercial infrastructure in glaucoma and corneal health, along with increased travel, meetings and accompanying costs as business activities have expanded.

Previous wording

The remaining increase of $10.1 million primarily relates to discretionary expenses supporting the above personnel growth as well as our ongoing administrative operations, inclusive of information technology, facilities and allocated expenses.

Current wording

The remaining increase of $27.5 million primarily relates to discretionary expenses supporting the above personnel growth as well as our ongoing administrative operations, inclusive of information technology, facilities and allocated expenses, as well as reserves on our accounts receivable.

Previous wording

During the six months ended June 30, 2025, we incurred $48.7 million in core R&D expenses and $20.2 million in clinical expenses, comprised of $45.1 million in compensation and related employee expenses with the remaining $23.8 million spent on the continued research and development, clinical studies, regulatory activities, quality assurance, clinical inventory and supplies for surgical glaucoma product candidates and pharmaceutical projects, such as next generationiDoseproducts*;* Epioxa, a pharmaceutical therapeutic system for the treatment of keratoconus without the removal of the epithelium (also referred to as “epi-on”); and our earlier stage programs for* *glaucoma, corneal, retinal and other therapeutic investments. For the six months ended June 30, 2024, we incurred $38.2 million in core R&D expenses and $26.9 million in clinical expenses, comprised of $38.8 million in compensation and related employee expenses with the remaining $28.9 million spent on the above-mentioned programs.

Current wording

During the nine months ended September 30, 2025, we incurred $75.6 million in core R&D expenses and $31.4 million in clinical expenses, comprised of $67.4 million in compensation and related employee expenses with the remaining $39.3 million spent on the continued research and development, clinical studies, regulatory activities, quality assurance, clinical inventory and supplies for surgical glaucoma product candidates and pharmaceutical projects, such as next generationiDoseproducts*;* Epioxa; and our earlier stage programs for* *glaucoma, corneal, retinal and other therapeutic investments. For the nine months ended September 30, 2024, we incurred $60.6 million in core R&D expenses and $39.3 million in clinical expenses, comprised of $59.1 million in compensation and related employee expenses with the remaining $40.8 million spent on the above-mentioned programs.

Previous wording

During the six months ended June 30, 2024, we issued $5.0 million of our common stock and paid approximately $5.1 million in cash, in connection with the asset acquisition of 100% of the outstanding equity interests in a clinical stage biopharma company focused on developing novel therapeutics for ophthalmic diseases, including all related patents and patent applications, technology and know-how. Also included in IPR&D for the six months ended June 30, 2024 is $1.3 million of contingent consideration related to our Sales Agreement with Celanese and our $2.5 million upfront payment related to a prior year license agreement, pursuant to which we obtained an exclusive, worldwide license to develop and commercialize drug products incorporating certain proprietary technology.

Current wording

During the nine months ended September 30, 2024, we issued $5.0 million of our common stock and paid approximately $5.1 million in cash, in connection with the asset acquisition of 100% of the outstanding equity interests in a clinical stage biopharma company focused on developing novel therapeutics for ophthalmic diseases, including all related patents and patent applications, technology and know-how. Also included in IPR&D for the nine months ended September 30, 2024 is $1.3 million of contingent consideration related to our Sales Agreement with Celanese and our $2.5 million upfront payment related to a prior year license agreement, pursuant to which we obtained an exclusive, worldwide license to develop and commercialize drug products incorporating certain proprietary technology.

Previous wording

We had non-operating income, net of $6.1 million and non-operating expense, net of $21.6 million for the six months ended June 30, 2025 and June 30, 2024, respectively. The change primarily relates to a decrease of $18.0 million of expense related to our June 2024 Convertible Notes exchange, a decrease of $2.8 million in interest expense on our Convertible Notes, and a change in unrealized foreign currency amounts recognized of approximately $4.8 million due to intercompany loan balances denominated in, and impacted by, changes in foreign currency exchange rates, as compared to the three months ended June 30, 2024.

Current wording

We had non-operating income, net of $6.5 million and non-operating expense, net of $18.2 million for the nine months ended September 30, 2025 and September 30, 2024, respectively. The change primarily relates to a decrease of $18.0 million of expense related to our June 2024 Convertible Notes exchange, a decrease of $5.0 million in interest expense on our Convertible Notes, and a change in unrealized foreign currency amounts recognized of approximately $1.4 million due to intercompany loan balances denominated in, and impacted by, changes in foreign currency exchange rates, as compared to the three months ended September 30, 2024.

Previous wording

Our effective tax rate for the six months ended June 30, 2025 and June 30, 2024 was (1.54)% and (0.78)%, respectively. For the six months ended June 30, 2025 and June 30, 2024, we recorded a provision for income taxes of $0.6 million and $0.7 million, respectively, which was primarily comprised of state and foreign income tax expense, offset by release of uncertain tax positions for which the statute of limitations has expired.

Current wording

Our effective tax rate for the nine months ended September 30, 2025 and September 30, 2024 was (1.52)% and (0.79)%, respectively. For the nine months ended September 30, 2025 and September 30, 2024, we recorded a provision for income taxes of $0.8 million and $0.9 million, respectively, which was primarily comprised of state and foreign income tax expense, offset by release of uncertain tax positions for which the statute of limitations has expired.

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Rearranged current paragraphs (4)

Current report — wording carried from elsewhere

The U.S. government recently announced tariffs on product imports from certain countries, including higher tariff levels on those imported from Canada, Mexico and China. These actions have resulted, and are expected to further result, in retaliatory measures on U.S. goods by those countries and others. While we believe our exposure to these tariffs and the potential escalation of trade disputes is limited as we primarily source our raw materials and product components from the U.S., these tariffs, or the introduction of new or higher tariffs in other countries, could pose a risk to our business, or the businesses of our customers, that could affect our net sales and cost of sourcing materials. In addition, the U.S. government shutdown that started on October 1, 2025 and continues as of the date of this report has impacted certain regulatory agencies, such as the U.S. FDA. Significant changes to operations at or the funding of such regulatory agencies could cause decreases in staff who are able to provide reimbursement services or changes in policy and enforcement priorities. Hospitals, ambulatory surgery centers and other health care providers may not purchase our products if they do not receive adequate reimbursement from third-party payors for procedures using our products. We have not yet experienced an adverse impact on our business operations due to this shutdown, but if it continues for a prolonged period of time, or if a widespread freeze on federal funding occurs, it could significantly

Current report — wording carried from elsewhere

On July 14, 2025 and July 15, 2025, the U.S. Centers for Medicare & Medicaid Services’ (CMS’) published its proposed rules on 2026 Medicare physician fee and facility fee payment rates (2026 Proposed Rules), respectively. The 2026 Proposed Rules reflected a modest increase with respect to facility fee payment rates in both the ASC and hospital outpatient setting over the 2025 Medicare facility fee payment rates with respect to procedures using our glaucoma

Current report — wording carried from elsewhere

in which we do not have a direct presence or only maintain a modest commercial presence. The primary end-user customers for our products are surgery centers, hospitals and physician private practices.

Current report — wording carried from elsewhere

these increased expenditures and their magnitude are primarily dependent on the commercial success and sales growth of our products, as well as on the timing of any new product launches and other potential business and operational activities.
Rearranged previous paragraphs (3)

Previous report — wording carried elsewhere

30, 2024. Additionally, the royalty income we received pursuant to a settlement agreement entered into during 2021 with Ivantis, Inc. (acquired by Alcon in 2022) relating to sales of the Hydrus® Microstent contractually expired on April 26, 2025.

Previous report — wording carried elsewhere

programs, including our expanding pharmaceutical development efforts and clinical trials across the glaucoma, corneal health and retinal disease spectrums.

Previous report — wording carried elsewhere

Acquired In-process Research and Development