02/23/2026 | Press release | Distributed by Public on 02/23/2026 05:02
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations together with our audited consolidated financial statements and related notes included in this Annual Report on Form 10-K. This discussion and analysis and other parts of this Annual Report on Form 10-K contain forward-looking statements that reflect our current plans, expectations, estimates and beliefs that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results and the timing of selected events may differ materially from those discussed in these forward-looking statements. You should carefully read Item 1A - "Risk Factors" included in this Annual Report on Form 10-K to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements. Please also see the section entitled "Special Note Regarding Forward-Looking Statements and Industry Data."
Overview
We are an ophthalmic pharmaceutical and medical technology company focused on developing novel, dropless platform therapies and commercializing associated products for the treatment of glaucoma, corneal disorders and retinal disease. We first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching our first MIGS device commercially in 2012. In 2024, we commenced commercialization activities for iDose TR, an intracameral procedural pharmaceutical implant designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time. We also offer commercially a proprietary bio-activated pharmaceutical therapy for the treatment of a rare corneal disorder, keratoconus, that was approved by the United States (U.S.) Food and Drug Administration (FDA) in 2016. Beyond our approved products, we continue to develop and advance a robust pipeline of novel, dropless platform technologies designed to advance the standard of care and improve outcomes for patients suffering from chronic eye diseases.
Financial Overview
The most important financial indicators that we use to assess our business are net sales, gross margin, operating expenses, and cash on hand.
|
December 31, |
December 31, |
||||||||
|
2025 |
2024 |
||||||||
|
Net sales |
$ |
507,442 |
$ |
383,481 |
|||||
|
Gross margin |
56 |
% |
75 |
% |
|||||
|
Operating expenses |
$ |
482,361 |
$ |
411,820 |
|||||
|
Cash, cash equivalents, short-term investments and restricted cash |
$ |
282,594 |
$ |
323,648 |
|||||
Please see Results of Operationsand Liquidity and Capital Resourcesbelow for a detailed discussion of each of the above items including analysis of the fluctuations from year to year.
We incurred net losses of $187.7 million, $146.4 million and $134.7 million for the years ended December 31, 2025, December 31, 2024, and December 31, 2023, respectively and as of December 31, 2025, we had an accumulated deficit of $933.1 million.
Recent Developments
On October 20, 2025, we announced U.S. FDA approval for Epioxaindicated for the treatment of keratoconus. Epioxarepresents an advancement in keratoconus care, offering an incision-free alternative to traditional corneal cross-linking procedures. Epioxais 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 Epioxain the first quarter of 2026. Accordingly, we assessed our long-lived assets
for impairment and determined that our remaining developed technology intangible asset related to Photrexawas no longer fully recoverable. As a result, we recorded an impairment charge within cost of sales in the consolidated statements of operations during the year ended December 31, 2025 of $112.9 million related to our Photrexadeveloped technology intangible asset.
In June 2025, we received European Union (EU) Medical Device Regulation (MDR) certification for our iStent family of products, including the iStent infiniteand the iStent inject W. We also received certification for our iStentproducts under the United Kingdom's Medical Device Regulation. We commenced some commercial launch activities in certain of our key EU markets in the third and fourth quarters of 2025.
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 equity holders 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.
On April 4, 2025, we purchased certain real property adjacent to our existing Aliso Viejo, California corporate headquarters (Aliso Facility), consisting of land and an approximately 40,000 square foot, two-story building, located in Aliso Viejo, California (Aliso Building). 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. We believe that 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.
Market and Business Update
Impact of the Current Global Economic Environment
As a result of the ongoing macroeconomic conditions, global and regional economies continue to experience varying levels of inflation, supply shortages or delays, changes in supply and demand, foreign exchange rate fluctuations, uncertainty around global trade, including 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 margin, our ability to ship some of our products to our customers, or bring some of our pipeline products to market, in a timely manner.
During 2025, the U.S. government announced tariffs on product imports from certain countries, including higher tariff levels on goods imported from Canada, Mexico and China. These actions have resulted, and could further result, in retaliatory measures on U.S. goods by those countries and others. On February 20, 2026, the U.S. Supreme Court struck down the international tariffs imposed by President Trump in 2025. President Trump has subsequently expressed his intent to reinstate the tariffs through other means which have not yet been disclosed. We are evaluating the impact of these developments, however 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. Nevertheless, 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.
The effects of foreign currency fluctuations were most notably experienced in our international glaucoma business. Our annual growth rate of net sales of our international glaucoma franchise for the year ended
December 31, 2025 was positively affected by approximately 208 basis points, primarily related to the Euro. For the year ended December 31, 2024, net sales of our international glaucoma business were negatively impacted by approximately 185 basis points, primarily related to the Japanese Yen.
Developments Impacting Reimbursement Rates and Coverage
In the U.S., healthcare providers use separate billing codes to report the provision of medical procedures and use of supplies to third-party payers, 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 the iStent infiniteor the implanting of iDose TRproducts, 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. As of December 31, 2025, the professional fees associated with an iDose TRprocedure have been formally published by four of the seven MACs. 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.
The unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code for iDose TR, 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 as iDose 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 of iDose TR, 0660T and 0661T, to APC 5492 (Level 2 Intraocular Procedures), retroactively effective as of January 1, 2024.
Now that Epioxa, our new CXL procedure, has been approved by the U.S. FDA, reimbursement is expected to primarily 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 of Epioxawill be covered by a temporary Category III CPT code, 0402T. Next, we will apply for a permanent HCPCS J-Code for Epioxaand 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.
On October 31, 2025 and November 21, 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 Final Rules), respectively. The 2026 Final 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 Final Rules 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 generally, including for cataract and surgical MIGS procedures specifically. The physician fee rules contained in the 2026 Final Rules do not affect the physician fees paid under temporary CPT codes for iDose TR and iStent infinite, because as explained above, those rates are determined on a MAC-by-MAC basis.
We estimate that approximately 80% of procedures utilizing our iDose TRand iStent family of products in the U.S. have been performed in the ASC setting and the remaining estimated 20% of procedures have been performed in the hospital.
Business Outlook
As discussed above, establishment of reimbursement for the iDose TRand its associated procedure has been an ongoing effort since its commercial launch in the first quarter of 2024. As reimbursement for the iDose TRprocedure continues to become a more timely and consistent process across all MACs, we anticipate utilization of iDose TRby our customers will increase accordingly.
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 our iStentfamily 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 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.
Our 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.
We anticipate some potential disruption within our U.S. Corneal Health franchise as the market transitions from Photrexato Epioxafollowing its approval and as we prepare for our planned controlled commercial launch in the first quarter of 2026.
Additionally, in January 2026, we received FDA approval of our supplemental new drug application (NDA) for the re-administration of iDose TRto patients who have previously received an iDose TRimplant.
Components of Results of Operations
Net Sales
Our net sales are generated primarily from sales of iDose TR, our iStentfamily of products, Photrexaand 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.
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 only maintain a modest commercial presence. The primary end-user customers for our products are surgery centers, hospitals and physician private practices.
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 we expect to be entitled in exchange for those products or services, which includes estimates of reductions to revenue for commercial and governmental rebates owed, variable consideration for product returns and other discounts and incentives.
Cost of Sales
Cost of sales reflects the aggregate costs to manufacture our products and includes raw material costs, labor costs, manufacturing overhead expenses and the effect of changes in the balance of reserves for excess and obsolete inventory.
We manufacture our iStentfamily of products and iDose TRat our facilities in San Clemente, California and our proprietary bioactivation systems at our manufacturing facility in Burlington, Massachusetts. We contract with third-party manufacturers in the U.S. and Germany to produce our Photrexaand other associated drug formulations. We currently intend to maintain our manufacturing facilities at our San Clemente and Burlington locations for the foreseeable future.
Due to the relatively low production volumes of our iStentfamily of products, iDose TRand our proprietary bioactivation systems compared to our potential capacity for those products, a significant portion of our per unit
costs is comprised of manufacturing overhead expenses. These expenses include quality assurance, material procurement, inventory control, facilities, equipment and operations supervision and management.
Cost of sales also includes amortization of the 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). Amortization expense was $26.8 million, $22.2 million and $22.1 million for the years ended December 31, 2025, December 31, 2024, and December 31, 2023, respectively.
In connection with our planned commercialization of Epioxa, we expect to transition commercial efforts and manufacturing from Photrexato Epioxain 2026. As mentioned in Recent Developments, we recorded an impairment charge within cost of sales in the consolidated statements of operations during the year ended December 31, 2025 of $112.9 million related to our Photrexadeveloped technology intangible asset.
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.
Selling, General and Administrative
Our selling, general and administrative (SG&A) expenses primarily consist of personnel-related expenses, including salaries, sales commissions, bonuses, fringe benefits and stock-based compensation for our executive, sales, marketing, market access, financial, legal, information technology and other administrative functions. Other significant SG&A expenses include marketing programs; advertising; post-approval clinical studies; conferences and congresses; travel expenses; costs associated with obtaining and maintaining our patent portfolio; professional fees for accounting, auditing, consulting and legal services; costs associated with our global enterprise systems and information systems; and allocated facility expenses.
SG&A expenses also include 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. Amortization expense for the years ended December 31, 2025, December 31, 2024 and December 31, 2023 was $0.4 million, $2.5 million and $2.8 million, respectively. The Avedro customer relationship intangible asset was fully amortized as of December 31, 2024.
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, enhancements in our global enterprise systems, 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.
Research and Development
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 glaucoma, corneal health and retinal disease.
Costs for our clinical development programs include expenses for all activities necessary for obtaining regulatory approvals. Our research programs vary significantly for each current and future product candidate and completion dates are difficult to predict. As a result, while we expect our R&D costs to continue to increase for the foreseeable future, we cannot estimate with any degree of certainty the timing or the amount of costs we will incur in connection with the development of our product candidates. We anticipate we will make determinations as to which programs and product candidates to pursue and how much funding to direct to each program and product candidate on an ongoing basis in response to the scientific success of early research programs, results of ongoing and future clinical trials, the availability of funding resources, as well as ongoing assessments as to each current or future product candidate's commercial potential and our likelihood of obtaining necessary regulatory approvals. We are not currently able to fully track expenses by product candidate.
Acquired In-Process Research and Development
Our acquired in-process research and development (IPR&D) expenses generally relate to acquisitions of technologies that management determines are not a business combination and do not have any alternative future uses. Future costs to develop these assets are expensed as R&D when incurred. We may have ongoing milestone and royalty payment obligations depending on the success, development, regulatory approval and commercialization of the proprietary technologies we have acquired.
Our IPR&D for the years ended December 31, 2024 and December 31, 2023 totaled $14.2 million and $5.0 million, respectively, relating to one-time upfront payments and stock issuances associated with our exclusive licensing agreements with various third-parties, whereby we were granted the exclusive, worldwide licenses for certain technologies that are in development. There were no IPR&D expenses during the year ended December 31, 2025.
We may have ongoing milestone and royalty payment obligations depending on the success, development regulatory approval and commercialization of the proprietary technologies we have acquired.
Non-Operating Income (Expense), Net
Non-operating income (expense), net primarily consists of interest expense associated with our finance lease for our Aliso Facility and for our previously-outstanding 2.75% convertible notes due 2027 (Convertible Notes), interest income derived from our short-term investments and unrealized gains and losses arising from exchange rate fluctuations on transactions denominated in a currency other than the U.S. dollar, primarily related to intercompany loans.
Income Taxes
Our tax (benefit) provision is primarily comprised of U.S. federal and state deferred taxes from a reduction of the valuation allowance associated with intangible assets changing from indefinite-lived to definite-lived for financial reporting purposes, as well as state and foreign income taxes offset by release of uncertain tax positions for which the statute of limitations has expired. Our net deferred tax liability of $0.4 million at December 31, 2025 primarily represents the excess of our indefinite-lived deferred tax liabilities over our indefinite-lived deferred tax assets. We continue to provide a full valuation allowance against our other net deferred tax assets.
We record reserves for uncertain tax positions where we believe the ability to sustain the tax position does not reach a more likely than not threshold.
Results of Operations
For discussion related to the results of operations and changes in financial condition for the year ended December 31, 2024 compared to the year ended December 31, 2023 refer to "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Part II, Item 7 of our 2024 Annual Report on Form 10-K, which was filed with the United States Securities and Exchange Commission on February 25, 2025.
Comparison of Years Ended December 31, 2025 and December 31, 2024
|
Year ended |
||||||
|
December 31, |
% Increase |
|||||
|
(in thousands) |
2025 |
2024 |
(decrease) |
|||
|
Statements of operations data: |
||||||
|
Net sales |
$507,442 |
$383,481 |
32% |
|||
|
Cost of sales |
224,681 |
94,027 |
139% |
|||
|
Gross profit |
282,761 |
289,454 |
(2)% |
|||
|
Operating expenses: |
||||||
|
Selling, general and administrative |
331,747 |
261,166 |
27% |
|||
|
Research and development |
150,614 |
136,425 |
10% |
|||
|
Acquired in-process research and development |
- |
14,229 |
(100)% |
|||
|
Total operating expenses |
482,361 |
411,820 |
17% |
|||
|
Loss from operations |
(199,600) |
(122,366) |
63% |
|||
|
Total non-operating income (expense), net |
6,558 |
(23,235) |
NM |
|||
|
Income tax (benefit) provision |
(5,351) |
771 |
NM |
|||
|
Net loss |
$(187,691) |
$(146,372) |
28% |
|||
Net Sales
Net sales for the years ended December 31, 2025 and December 31, 2024 were $507.4 million and $383.5 million, respectively, reflecting an increase of $123.9 million or 32% primary related to the factors listed below.
Net sales of glaucoma products in the United States were $298.6 million and $199.6 million for the years ended December 31, 2025 and December 31, 2024, respectively, increasing by approximately 50%. This increase is primarily due to higher volumes of sales iDose TR, which has a higher net sales price than our other products, partially offset by a single digit decline in the net sales of our non-iDoseproducts, primarily due to the MIGS restrictions associated with the final LCD issued by the five MACs as described above in the Market and Businesssection.
International sales of glaucoma products for the years ended December 31, 2025 and December 31, 2024 were $122.5 million and $103.7 million, respectively, increasing by approximately 18%. The increase in international sales reflects continued broad-based volume growth in many key international markets for glaucoma procedures, primarily France, the United Kingdom, and Japan, the dollar-based results of which were slightly affected by favorable foreign exchange rates over the course of the year, primarily related to the Euro, during the year ended December 31, 2025 as compared to the year ended December 31, 2024.
Net sales of corneal health products were $86.4 million and $80.2 million for the years ended December 31, 2025 and December 31, 2024, respectively, increasing by 8%. Of the approximately $6.2 million increase in net sales generated by our corneal health products, $6.3 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 Photrexaalong with 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 of iLinkdevices in the U.S. decreased $0.4 million for the year ended December 31, 2025 as compared to the year ended December 31, 2024. Our international corneal health sales increased $0.2 million from net sales in countries outside the U.S. during the year ending December 31, 2025 as compared to the year ended December 31, 2024.
Cost of Sales
Cost of sales for the years ended December 31, 2025 and December 31, 2024 were $224.7 million and $94.0 million, respectively, reflecting an increase of approximately $130.7 million or 139%. Of the total increase of $130.7 million, the impact of the aforementioned Photrexadeveloped technology impairment was $112.9 million. The remaining increase in cost of sales of $17.8 million is generally proportionate to the increase in net sales for the corresponding period, as well as contributions from increased iDose TRproduction andiDose TRnet sales. Our gross margin was approximately 56% and 75% for the years ended December 31, 2025 and December 31, 2024, respectively.
Selling, General and Administrative Expenses
SG&A expenses for the years ended December 31, 2025 and December 31, 2024 were $331.7 million and $261.2 million, respectively, reflecting an increase of $70.5 million or 27%.
Of the total $70.5 million increase in SG&A expenses for the year ended December 31, 2025 as compared to the year ended December 31, 2024, $27.1 million related to increased compensation and related employee costs, with $11.9 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 year. 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.
The remaining increase of $43.4 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 calculated based on our accounts receivable reserve methodology.
Research and Development Expenses
R&D expenses for the years ended December 31, 2025 and December 31, 2024 were $150.6 million and $136.4 million, respectively, reflecting an increase of $14.2 million or 10%.
For the year ended December 31, 2025, we incurred $107.1 million in core R&D expenses and $43.5 million in clinical expenses, comprised of $91.3 million in compensation and related employee expenses, $2.0 million of which was related to increased stock-based compensation, with the remaining $59.3 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 generation iDose and Epioxa products; and our earlier stage programs for glaucoma, corneal, retinal and other therapeutic investments. For the year ended December 31, 2024, we incurred $84.6 million in core R&D expenses and $51.8 million in clinical expenses, comprised of $79.9 million in compensation and related employee expenses with the remaining $56.5 million spent on the above-mentioned programs.
Acquired In-process Research and Development
There was no IPR&D expense for the year ended December 31, 2025. During the year ended December 31, 2024, we issued $5.0 million of our common stock, paid approximately $5.1 million in cash, and incurred $1.6 million of contingent consideration 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 year ended December 31, 2024 is a $2.5 million payment related to an additional license agreement pursuant to which we obtained an exclusive, worldwide license to develop and commercialize drug products incorporating certain proprietary technology.
Non-Operating Income (Expense), Net
We had non-operating income of $6.6 million and non-operating expense of $23.2 million for the years ended December 31, 2025 and December 31, 2024, respectively. The $29.8 million change primarily relates to charges associated with our Convertible Note Exchange during the year ended December 31, 2024.
Income Tax (Benefit) Provision
Our effective tax rate for the year ended December 31, 2025 was 2.8%. For the year ended December 31, 2025, we recorded a (benefit) for income taxes of $(5.4) million, which was primarily comprised of U.S. federal and state deferred taxes from a reduction of the valuation allowance associated with intangible assets changing from indefinite-lived to definite-lived for financial reporting purposes, as well as state and foreign income tax expense offset by release of uncertain tax positions for which the statute of limitations has expired. For the year ended December 31, 2024, we recorded a provision for income taxes of $0.8 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.
Liquidity and Capital Resources
Our principal sources of liquidity are our existing cash, cash equivalents and short-term investments, and generally cash generated from operating, financing and investing activities. Our primary uses of cash have been for commercial activities, acquired in-process research and development, clinical and research and development programs, general and administrative expenses, and capital expenditures.
The following table summarizes our cash and cash equivalents, short-term investments and selected working capital data as of December 31, 2025 and December 31, 2024 (in thousands):
|
December 31, |
December 31, |
|||||||
|
2025 |
2024 |
|||||||
|
Cash and cash equivalents |
$ |
90,813 |
$ |
169,626 |
||||
|
Short-term investments |
187,947 |
149,289 |
||||||
|
Accounts receivable, net |
108,608 |
60,744 |
||||||
|
Inventory |
63,564 |
57,678 |
||||||
|
Accounts payable |
24,624 |
13,026 |
||||||
|
Accrued liabilities |
76,651 |
62,099 |
||||||
|
Working capital (1) |
373,709 |
374,667 |
||||||
Main Sources of Liquidity
We plan to fund our operations, commitments for capital expenditures and other short and long-term known contractual and other obligations using existing cash and investments and, to the extent available, cash received from commercial operations as well as cash generated from employee stock option exercises.
We may seek to obtain additional financing in the future through debt or equity financings. There can be no assurance that we will be able to obtain additional financing on terms acceptable to us, or at all and although we have been profitable for certain periods in our operating history, there can be no assurance that we will be profitable or generate cash from operations in the future.
Cash, Cash Equivalents, Short-term Investments and Restricted Cash
As of December 31, 2025, our cash, cash equivalents and short-term investments totaled approximately $278.8 million and our restricted cash totaled approximately $3.8 million.
Cash Flow used in Operations
For the twelve months ended December 31, 2025, our operating activities used $14.8 million in net cash.
Short-term Liquidity Requirements
Our short-term liquidity requirements primarily consist of regular operating costs, R&D project funding, capital expenditures as we continue the development of our manufacturing facilities and office spaces, operating and financing lease obligations, government rebate obligations, and other firm purchase commitments. As of December 31, 2025, we had net working capital of $373.7 million, which indicates that our current assets are sufficient to cover our short-term liabilities.
Long-term Liquidity Requirements
Our long-term liquidity requirements primarily consist of capital expenditures for the continued development of our manufacturing facilities and office spaces, potential future payments related to our licensing agreements and acquisitions, and firm purchase commitments. As demand grows for our products, we will continue to expand global operations to meet demand through investments in our manufacturing capabilities. To that end, we entered into agreements with the city of Huntsville, Alabama that provide an opportunity to develop a new 200,000 square foot R&D and manufacturing facility, which is anticipated to result in more than $80.0 million in capital expenditures over the multi-year project. We expect construction to begin in 2026.
Material Cash Requirements
The following table summarizes our material cash requirements, including commitments for capital expenditures and known contractual and other obligations as of December 31, 2025, and the amount required to satisfy those requirements in future periods.
|
Payments due by period |
||||||||||||||||||||
|
Less than |
More than |
|||||||||||||||||||
|
(in thousands) |
Total |
1 year |
1 - 3 years |
3 - 5 years |
5 years |
|||||||||||||||
|
Operating and finance lease obligations |
$ |
175,366 |
$ |
9,727 |
$ |
20,299 |
$ |
20,748 |
$ |
124,592 |
||||||||||
|
Firm purchase commitments |
55,497 |
46,872 |
8,623 |
2 |
- |
|||||||||||||||
|
Total |
$ |
230,863 |
$ |
56,599 |
$ |
28,922 |
$ |
20,750 |
$ |
124,592 |
||||||||||
After funding the current operations of our commercial and marketing activities, the first planned use of our cash flow from operations is to provide capital funding for our R&D and clinical activities. In addition to investing in R&D and clinical activities, we expect to utilize cash for various capital expenditures. We have made and expect to continue to make significant investments in our global sales force, marketing programs, market access, research and development activities, clinical studies, facilities and general and administrative infrastructure.
We believe that cash from operating, financing and investing activities, together with our cash and investment balances, will be sufficient to meet ongoing operations, capital expenditures, commitments, working capital requirements and other known contractual and other obligations and satisfy our liquidity requirements for at least the next 12 months and the foreseeable future.
Cash Flows
Our historical cash outflows have primarily been associated with cash used for operating activities such as the expansion of our commercial and R&D activities; deployment of working capital for accounts receivable, inventory and other items; the acquisition of intellectual property; and expenditures related to equipment and improvements used to increase our manufacturing capacity and improve our manufacturing efficiency and for overall facility expansion.
The following table is a condensed summary of our cash flows for the periods indicated:
|
Year ended |
||||||||
|
December 31, |
||||||||
|
(in thousands) |
2025 |
2024 |
||||||
|
Net cash (used in) provided by: |
||||||||
|
Operating activities |
$ |
(14,789 |
) |
$ |
(61,318 |
) |
||
|
Investing activities |
(77,613 |
) |
47,831 |
|||||
|
Financing activities |
11,886 |
91,540 |
||||||
|
Exchange rate changes |
804 |
(3,017 |
) |
|||||
|
Net (decrease) increase in cash, cash equivalents and restricted cash |
$ |
(79,712 |
) |
$ |
75,036 |
|||
At December 31, 2025, our cash and cash equivalents were held for working capital purposes. We do not enter into investments for trading or speculative purposes. Our policy is to invest any cash in excess of our immediate requirements in investments designed to preserve the principal balance and provide liquidity.
Operating Activities
In the years ended December 31, 2025 and December 31, 2024 our operating activities used $14.8 million and $61.3 million, respectively.
For the year ended December 31, 2025, our net cash used in operating activities reflected our net loss of $187.7 million, adjusted for non-cash items of $220.9 million, primarily consisting of impairment of our developed technology intangible asset of $112.9 million, stock-based compensation expense of $63.2 million, depreciation of $11.0 million, amortization of intangible assets of $27.1 million, non-cash lease expense of $4.3 million, allowance for doubtful accounts of $7.4 million, amortization of premium on short-term investments of $3.0 million, provision for excess and obsolete inventory $1.3 million, and an inventory write-down charge of $2.6 million. Additionally, changes in operating assets and liabilities resulted in a net use of cash of $48.0 million, which resulted primarily from increases in accounts receivable of $53.0 million, mostly because extended payment terms have been offered as part of our iDose TRcommercial launch during 2025, increases in inventory of $7.7 million and prepaid expenses and other current assets of $11.3 million, partially offset by increases in accounts payable and accrued liabilities of $18.8 million, as well as a reduction in other assets of $5.2 million.
For the year ended December 31, 2024, our net cash used in operating activities reflected our net loss of $146.4 million, adjusted for non-cash items of $125.1 million, primarily consisting of stock-based compensation expense of $50.2 million, depreciation of $10.9 million, inducement expense related to Convertible Notes Exchange of $17.4 million, amortization of intangible assets of $24.7 million, non-cash lease expense of $4.3 million, amortization of debt issuance costs of $0.7 million, amortization of premium of $4.0 million, provision for excess and obsolete inventory $0.7 million, a write-down charge of $4.4 million associated with product line optimizations that was recorded against inventory and prepaid assets and other assets, and IPR&D acquired through issuance of common stock of $5.0 million. Additionally, changes in operating assets and liabilities resulted in a net use of cash
of $40.0 million, which resulted primarily from increases in accounts receivable of $21.9 million, mostly because extended payment terms have been offered as part of our iDose TRcommercial launch during 2024, increases in inventory of $19.5 million, an increase in other assets of $2.1 million, partially offset by decreases in prepaids and other current assets of $3.3 million.
Investing Activities
In the years ended December 31, 2025 and December 31, 2024, our investing activities used cash of $77.6 million and provided cash of $47.8 million, respectively.
In the year ended December 31, 2025, we used approximately $232.3 million for purchases of short-term investments, approximately $16.6 million related to the purchase of the Aliso Building acquisition, approximately $12.4 million related to the Mobius Merger, and approximately $7.7 million for purchases of property and equipment, primarily related to our facilities in Aliso Viejo, California; and San Clemente, California. We also received cash of approximately $196.9 million from sales and maturities of short-term investments and used approximately $4.8 million related to investments in company-owned life insurance.
In the year ended December 31, 2024, we used approximately $190.0 million for purchases of short-term investments, and approximately $6.3 million for purchases of property and equipment, primarily related to our facilities in Aliso Viejo, California; and San Clemente, California. We also received cash of approximately $247.2 million from sales and maturities of short-term investments and used approximately $3.2 million related to investments in company-owned life insurance.
We expect levels of our capital expenditures to be higher in 2026 than in 2025 in connection with the construction of our Huntsville, Alabama property, as well as expected upgrades to certain manufacturing facilities and continued investing in R&D equipment needed to advance our product pipeline.
Financing Activities
In the years ended December 31, 2025 and December 31, 2024, our financing activities provided $11.9 million and $91.5 million of net cash, respectively.
In the year ended December 31, 2025, we received $21.1 million from the exercises of stock options and purchases of our common stock by employees pursuant to our Employee Stock Purchase Plan and used $8.1 million for payment of employee taxes related to restricted stock unit vestings. Additionally, we paid $1.1 million in principal on our finance lease.
In the year ended December 31, 2024, we received $53.2 million related to our Capped Call Unwind Agreements, $46.8 million from the exercises of stock options and purchases of our common stock by employees pursuant to our Employee Stock Purchase Plan and used $6.6 million for payment of employee taxes related to restricted stock unit vestings. Additionally, we paid $0.9 million in principal on our finance lease.
We do not have any off-balance sheet arrangements.
Critical Accounting Policies and Significant Estimates
Management's discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (GAAP). The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities and related disclosure of contingent assets and liabilities, revenue and expenses at the date of the consolidated financial statements. Generally, we base our estimates on historical experience and on various other assumptions in accordance with GAAP that we believe to be reasonable under the circumstances. Actual results may differ materially from these estimates under different assumptions or conditions and such differences could be material to our financial position and results of operations.
While our significant accounting policies are more fully described below and in the Notes to our consolidated financial statements in Part II, Item 8 in this Annual Report on Form 10-K, we believe the following accounting policy to be most critical for fully understanding and evaluating our financial condition and results of operations.
Revenue Recognition
We derive our revenue from sales of our 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 we do not have a direct commercial presence.
We concluded that one performance obligation exists for the majority of our contracts with customers which is to deliver products in accordance with our normal delivery times. Revenue is recognized when this performance obligation is satisfied, which is the point in time when we consider control of a product to have transferred to the customer. Revenue recognized reflects the consideration to which we expect to be entitled in exchange for those products or services. We have determined the transaction price to be the invoice price, net of adjustments that reduce revenue, which includes estimates of rebates for government pricing programs, volume-based rebates, variable consideration for certain product returns, and other discounts and incentives that reduce revenue.
We only recognize revenue when it is probable that we will collect the consideration we are entitled to in exchange for the goods transferred to a customer. This requires management to perform an assessment related to the probability of collecting the consideration. The assessment can contain judgment when it is performed for customers with declining credit conditions or those with no history or a limited history of product sales with us.
Non-volume-based rebates consist primarily of rebates for government pricing programs, which were estimated using the expected value method, based upon a range of possible outcomes for the estimated number of actual claims invoices we expect to receive. We apply this estimate to the respective period's sales to determine the rebate accrual and related expense. This estimate is evaluated regularly to ensure that the historical trends are as current as practicable. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue.
We offer volume-based rebate agreements to certain customers and, if earned by the customer, we provide a rebate (in the form of a credit memo) at the contract's conclusion. In such cases, the transaction price is allocated between our delivery of product and the issuance of a rebate at the contract's conclusion for the customer to utilize on prospective purchases. The performance obligation to issue a customer's rebate, if earned, is transferred over time and our method of measuring progress is the output method, whereby the progress is measured by the estimated rebate earned to date over the total rebate estimated to be earned over the contract period. The provision for volume-based rebates is estimated based on customers' contracted rebate programs and the customers' projected sales levels.
We regularly monitor our rebate programs to evaluate the rebate allowance is fairly stated. Our rebate allowance is included in accrued liabilities in the consolidated balance sheets.
Additionally, we have performance obligations related to voluntary patient assistance programs to provide financial assistance to qualified patients. This performance obligation is expected to be recognized when the customer or patient elects to utilize the discount, which is generally within one year. The impact of these programs on revenue were not material for the periods presented.
Customers are not granted specific rights of return; however, we may permit returns of certain products from customers if such product is returned in a timely manner and in good condition. We generally provide a warranty on our products for one year from the date of shipment, and offer an extended warranty for our KXL systems. Any product found to be defective or out of specification will be replaced or serviced at no charge during the warranty period. Estimated allowances for sales returns and warranty replacements are recorded at the time of sale of the product and are estimated based upon the historical patterns of product returns matched against sales, and an evaluation of specific factors that may increase the risk of product returns. Product returns and warranty replacements to date have been consistent with amounts reserved or accrued and have not been significant. If actual
results in the future vary from our estimates, we will adjust these estimates which would affect net product revenue and earnings in the period such variances become known.
Recent Accounting Pronouncements
For a description of recent accounting pronouncements, see Note 2of the notes to our consolidated financial statements included in Part II, Item 8 of this Annual Report on Form 10-K.