RXST 10-K & 10-Q changes, risk factors and insider trading
RxSight, Inc. · Nasdaq · Ophthalmic Goods · CIK 1111485 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Changes in U.S. trade policy, including recently announced tariffs, could have a material adverse impact on our business, financial condition, and results of operations.”
New heading “Uncertainties with respect to the development, deployment, and use of artificial intelligence in our business and products may result in harm to our business and reputation.”
New heading “Our IT systems, contractors or consultants or potential future collaborators, may fail or suffer actual or suspected security or privacy breaches or incidents or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data, or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm our brand and cause material disruption to our operations.”
Removed heading “We may experience a significant disruption in our information technology systems or breaches of data security.”
Largest changes
“Any disruption, security incident, or security breach resulting in any loss, destruction, unavailability, alteration or dissemination of, or damage to, our data, could subject us to significant fines or penalties for any noncompliance with certain state, federal and/or international laws relating to privacy, data protection, and information security. Litigation and governmental investigations could force us to spend money in defense or settlement, divert management’s time and attention, increase our costs of doing business, and/or adversely affect our reputation. …”see in full comparison
“Additionally, the current inflationary environment may materially affect our business and operating results by increasing the costs of our supplies and may drive the U.S. Federal Reserve system to increase interest rates, which in turn may increase our overhead costs. Rising interest rates could make it more difficult to obtain traditional financing on acceptable terms, if at all. Furthermore, such economic conditions have produced downward pressure on share prices. …”see in full comparison
“Despite the implementation of security measures in our efforts to protect systems that store our information, given their size and complexity and the increasing amounts of information maintained on our internal information technology systems and external processing and storage systems (e.g., hosting), contractors and consultants and other third-party service providers, these systems are potentially vulnerable to breakdown or other damage or interruption. …”see in full comparison
“Our IT systems, contractors or consultants or potential future collaborators, may fail or suffer actual or suspected security or privacy breaches or incidents or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data, or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm our brand and cause material disruption to our operations.”see in full comparison
“Following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted against that company. Following a stock price drop in our securities, on July 22, 2025, a putative securities class action complaint was filed in the U.S. District Court for the Central District of California against us and certain of our officers, captioned Makaveev v. RxSight, Inc., et al., No. 8:25-cv-01596. A second complaint, captioned Gemesi v. RxSight, Inc., et al., No. …”see in full comparison
“Changes in U.S. trade policy, including recently announced tariffs, could have a material adverse impact on our business, financial condition, and results of operations.”see in full comparison
Full comparison: every changed paragraph (157)
We have a limited operating history, and ifIf we fail to effectively train our sales force, increase our sales and marketing capabilities, or develop broad brand awareness in a cost-effective manner, our growth will be impeded, and our business will suffer.
We have a history of net operating losses, and we expect to continue to incur losses in the future. If we ever achieve profitability, we may not be able to sustain it.
We have commenced, and intend to expand in the future, sales of our products internationally in the future,internationally, but we may experience difficulties in obtaining regulatory clearance or approval or in successfully marketing our products internationally even if approved.
We may experience a significant disruption in our information technology systems or breaches of data security.
Current and future litigation proceedings could adversely affect our business., including the putative securities class action complaint filed in July 2025 in the U.S. District Court for the Central District of California which is pending.
Future litigation proceedings could adversely affect our business.
We have a limited operating history and ifIf we fail to effectively train our sales force, increase our sales and marketing capabilities or develop broad brand awareness in a cost-effective manner, our growth will be impeded, and our business will suffer.
We were incorporated in March 1997 and began commercializing our products in the second half of 2019, when we initiated a full launch of our LAL and LDD. Accordingly, our limited commercialization experience and limited number of approved or cleared products make it difficult to evaluate our current business and assess our prospects. We also currently have limited sales and marketing experience. If we are unable to establish or scale effective sales and marketing capabilities, or if we are unable to commercialize any of our products, we may not be able to generate sufficient product revenue, sustain revenue growth and compete effectively. In order to generate future growth, we plan to continue to expand and leverage our sales and marketing infrastructure to increase our customer base and grow our business.
While sales declined in 2025 following several years of rapid growth, we have implemented changes in our sales organization in an effort to return to revenue growth in absolute dollars. In order to increase LAL use at our current customers, we recently realigned our commercial structure by unifying our LAL sales and clinical support personnel into a single Customer Success Organization. Each team within the Customer Success Organization is responsible for a defined group of doctors and practices, overseeing customer experience from initial onboarding through ongoing efforts to drive long-term utilization growth. Our LDD sales team remains focused on acquiring new high-potential accounts, which are subsequently transitioned to the Customer Success Organization for clinical support, education, and to maximize long-term utilization and growth and LAL use.
These factors also make it difficult for us to forecast our financial performance and growth, and such forecasts are subject to a number of uncertainties, including our ability to successfully develop additional products that add functionality, reduce the cost of products sold, and broaden our commercial portfolio offerings and our ability to obtain the required regulatory approvals and clearances under applicable law both domestically and internationally, including FDA 510(k) clearance or pre-market approval, or PMA,(“PMA”), for, and successfully commercialize, market and sell, our planned or future products in the United StatesU.S., or in international markets. If our assumptions regarding the risks and uncertainties we face, which we use to plan our business, are incorrect or change due to circumstances in our business or our markets, or if we do not address these risks successfully, our operating and financial results could differ materially from our expectations and our business could suffer.
Moreover, in the event that we enter into collaborations or licensing arrangements to raise capital, we may be required to accept unfavorable terms. These agreements may require that we relinquish or license to a third party on unfavorable terms our rights to products or technologies we otherwise would seek to develop or commercialize ourselves, or reserve certain opportunities for future potential arrangements when we might be able to achieve more favorable terms. We may be unable to raise additional funds or to enter into such agreements or arrangements on favorable terms, or at all. Our ability to raise additional funds may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United StatesU.S. and worldwide resulting from the conflicts in Eastern Europe, the Middle East and otherwise.
As of December 31, 2024,2025, we had $237.2$228.1 million in cash, cash equivalents and short-term investments. While we believe that our existing cash, cash equivalents and short-term investments and anticipated cash generated from sales of our products will be sufficient to meet our anticipated cash needs for at least 12 months following the date of this report, wethere cannotis assureno youassurance that we will be able to generate sufficient liquidity as and when needed. Further, although we do not anticipate the need to raise additional capital or incur additional debt in order to reach profit from operations, as such metric may be disclosed in the Company’s future Annual Reports on Form 10-K or Quarterly Reports on Form 10-Q filed with the SEC, we may opportunistically seek to raise capital under advantageous circumstances from time to time in order to support the expansion of our sales and operations in the U.S. and internationally and to pursue other business opportunities. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. WeThere cannotis assureno youassurance that we will be able to generate sufficient liquidity as and when needed.
Global economic, political and market conditions, including downgrades of the U.S. credit rating, and inflation may adversely affect our business, results of operations and financial condition, including our revenue growth and profitability.
Deterioration in the economic conditions globally resultinghas resulted in instability in global financial markets, including: inflation and rising interest rates and instability in the capital markets.
Various social and political circumstances in the U.S. and around the world (including wars and other forms of conflict, terrorist acts, security operations and catastrophic events such as fires, floods, earthquakes, tornadoes, hurricanes and global health epidemicspandemic) may also contribute to increased market volatility and economic uncertainties or deterioration in the U.S. and worldwide and have a material adverse effect on our business, financial conditions, results of operations and prospects.
Additionally, the current inflationary environment may materially affect our business and operating results by increasing the costs of our supplies and may drive the U.S. Federal Reserve system to increase interest rates, which in turn may increase our overhead costs. Rising interest rates could make it more difficult to obtain traditional financing on acceptable terms, if at all. Furthermore, such economic conditions have produced downward pressure on share prices. Although we do not believe that inflation has had a material impact on our financial positions or results of operations to date, additional high inflation could increase our operating costs, including our labor costs and research and development costs. These costs may also be negatively impacted due to supply chain constraints, global geopolitical tensions, worsening macroeconomic conditions and employee availability and wage increases, which may result in additional stress on our working capital. We import from China certain materials and other components for use in our products, and such goods are subject to tariffs. Increases in tariffs could result in increased costs.
Changes in U.S. trade policy, including recently announced tariffs, could have a material adverse impact on our business, financial condition, and results of operations.
Changes in U.S. trade policy, including recently announced tariffs, could have a material adverse impact on our business, financial condition, and results of operations. The imposition of retaliatory or new tariffs or increases in existing tariffs on goods imported from countries where we source our products could result in increased material costs for our products. If we are unable to mitigate these risks through supply chain adjustments, such as changing vendors, pricing strategies, or other measures could adversely affect our gross margins, business, financial condition and results of operations.
our ability to obtain regulatory approval to market our planned or future products for use in the United StatesU.S. or internationally;
the degree of patient willingness to pay for the additional costs associated with our premium intraocular lens out of pocket or return for an additional two to three clinic visits compared to traditional cataract surgery;
our reputation among doctorsdoctors, patients, and the market;
the strength of our marketingmarketing, clinical support, and commercial organization;
the effectiveness of our marketing and sales efforts in the United States,U.S., including our efforts to build out our sales and clinical team;
our ability to continue to develop, validate and maintain a commercially viable manufacturing process that is compliant with the QualityQMSR, Systemswhich Regulations (“QSR”), or QSMR when it goeswent into effect in February 2026, and other applicable foreign, federal and state regulatory requirements;
We currently require limited training in the use of our products because we market primarily to doctors who are experienced in the specific techniques required to use our devices. If demand for our products continues to grow, less experienced doctors will likely use our products, potentially leading to more injury and an increased risk of product liability claims. The use or misuse of our products may in the future result in complications and potentially lead to product liability claims.
In order for doctors to use our RxSight system, they often must make a significant up-front investment to purchase the LDD. This can result in a lengthy sales cycle and require extensive negotiations and management time. If we are unsuccessful in placing LDDs with providers, our sales growth may stall and our sales may decrease, and our operating results may be harmed.
Doctors play a significant role in determining the course of a patient’s treatment, and, as a result, the type of treatment that will be utilized and provided to a patient. We focus our sales, marketing and education efforts primarily on doctors, and aim to educate referring doctors on the patient population that would benefit from our products. However,There weis cannotno assure youassurance that we will achieve broad market acceptance among doctors.
For example, some doctors may choose to utilize our RxSight system on only a subset of their total patient population or may not adopt our RxSight system at all. If we are not able to effectively demonstrate that the use of our RxSight system is beneficial in a broad range of patients, adoption of our product will be limited and may not occur as rapidly as we anticipate or at all, which would have a material adverse effect on our business, financial condition and results of operations. WeThere cannotis assureno youassurance that our products will achieve broad market acceptance among doctors. Additionally, even if our products achieve market acceptance, they may not maintain that market acceptance over time if competing products, procedures or technologies are considered safer or more cost-effective or otherwise superior. Any failure of our products to generate sufficient demand or to achieve meaningful market acceptance and penetration will harm our future prospects and have a material adverse effect on our business, financial condition and results of operations.
The medicalIOL device industrymarket is intensely competitive, subject to rapid change and significantlyis affectedconstantly impacted by new product introductions and other market activities of industry participants. We compete with manufacturers and distributors of premium and conventional IOLs. Our most significant competitors in the IOL field include Alcon andAlcon, Johnson & Johnson.Johnson Manyand Bausch + Lomb, which all continue to develop and release new IOL products and technologies. Most of our competitors are large, well-capitalized companies with significantly greater market share and resources than we have. Therefore, they can spend more on product development, marketing, sales and other product initiatives than we can. We also compete with smaller medical device companies that have a single product or a limited range of products. In addition, patients who receive an LAL will be required to wear UV protective glasses until final lock-in which is approximately four to five weeks after surgery. They will also be required to return for an additional two to three clinic visits compared to traditional monofocal cataract surgery. The additional clinic visits are non-surgical but do require the patient’s eyes to be dilated. Due to these additional requirements, market acceptance of the LAL may be impacted. We believe the principal competitive factors in our markets include:
Doctor learning curves and willingness to adopt new technologiestechnologies, particularly during competitive launch periods;
expand our sales forceand clinical teams across key markets to increase doctors’ awareness;
WeThere can provideis no assurance that we will be successful in developing new products or commercializing them in ways that achieve market acceptance. If we develop new products, sales of those products may reduce revenue generated from our existing products. Moreover, any significant delays in our product launches may significantly impede our ability to enter or compete in a given market and may reduce the sales that we are able to generate from these products. We may experience delays in any phase of a product development, including during research and development, clinical trials, regulatory review, manufacturing and marketing. Delays in product introductions could have a material adverse effect on our business, financial condition and results of operations.
collaborators may not pursue development and commercialization of our products or may elect not to continue or renew development or commercialization programs based on clinical trial or test results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;
We currently maintain our research and development, manufacturing and administrative operations in Aliso Viejo, California, and we do not have redundant facilities. We operate in fourfive separate facilities, designated as a single manufacturing facility, and should any one of these facilities be significantly damaged or destroyed by natural or man-made disasters, such as earthquakes, and/or fires (both of which are prevalent in California) or other events, it could take months to relocate or rebuild, during which time our employees may seek other positions, our research, development and manufacturing would cease or be delayed and our products may be unavailable. A major interruption in the manufacturing operations at this facility would materially impact our ability to operate. Because of the time required to authorize manufacturing in a new facility under federal, state and non-U.S. regulatory requirements, we may not be able to resume production on a timely basis even if we are able to replace production capacity. While we maintain property and business interruption insurance, such insurance has limits and would not cover all damages, including losses caused by earthquakes or losses we may suffer due to our products being replaced by competitors’ products. The inability to perform our research, development and manufacturing activities if our facilities become inoperable, combined with our limited inventory of materials and components and manufactured products, may cause doctors to discontinue using our products or harm our reputation, and we may be unable to re-establish relationships with such doctors in the future. Consequently, a catastrophic event at our current facility or any future facilities could have a material adverse effect on our business, financial condition and results of operations.
Furthermore, the current leases on our four facilities expire on January 31, 2031, with two options to extend for five years each. We may be unable to renew our leases or find a new facility on commercially reasonable terms, or at all. If we wereare unable or unwilling to renew at the proposed rates, relocating our manufacturing facility would involve significant expense in connection with the movement and installation of key manufacturing equipment and any necessary recertification with regulatory bodies, and we cannot assure you that such a move would notcould delay or otherwise adversely affect our manufacturing activities or operating results. If our manufacturing capabilities were impaired by any such move, we may not be able to manufacture and ship our products in a timely manner, which would adversely impact our business.
The medical deviceIOL market is characterized by extensive research and development and rapid technological change. There can be no assurance that other companies, including current competitors or new entrants, will not succeed in developing or marketing products that are more effective than our products or that would render our products obsolete or noncompetitive. Additionally, new surgical procedures, medications and other therapies could be developed that replace or reduce the importance of our products. If we are unable to innovate successfully, our products could become obsolete and our revenue would decline as our customers purchase our competitors’ products. Our failure to develop new products, applications or features could result from insufficient cash resources, high employee turnover, inability to hire personnel with sufficient technical skills,skills or replace key personnel, a lack of other research and development resources or other constraints. Our failure or inability to devote adequate research and development resources or compete effectively with the research and development programs of our current or future competitors could have a material adverse effect on our business, financial condition and results of operations.
Uncertainties with respect to the development, deployment, and use of artificial intelligence in our business and products may result in harm to our business and reputation.
We are in the early stages of incorporating artificial intelligence (“AI”) into our business activities and our product and service offerings. As with many innovations, AI presents risks and challenges that could adversely impact our business. The development, adoption, and use of AI technologies are still in their early stages and ineffective or inadequate AI development or deployment practices could result in unintended consequences. For example, AI algorithms may be flawed or may be based on datasets that are biased or insufficient. In addition, any disruption or failure in the AI functionality we incorporate into our business activities, products or services could adversely impact our business or result in delays or errors in our offerings. Conversely, a failure to timely and effectively use or deploy AI and integrate it into new product offerings and services could negatively impact our competitiveness, particularly ahead of evolving industry trends and evolving consumer demands. We may be unable to devote adequate financial resources to develop or acquire new AI technologies and systems in the future. Use of AI to improve internal business operations, or in the development or provision of products or services, poses risks and challenges. There also may be real or perceived social harm, unfairness, or other outcomes that undermine public confidence in the use and deployment of AI. Any of the foregoing may result in decreased demand for our products or harm to our business, financial statements or reputation. The legal and regulatory landscape surrounding AI technologies is rapidly evolving and uncertain, including in the areas of intellectual property, cybersecurity and privacy and data protection. Compliance with new or changing laws, regulations or industry standards relating to AI may impose significant costs and may limit our ability to develop, deploy or use AI technologies. Failure to appropriately respond to this evolving landscape may result in legal liability, regulatory action, or brand and reputational harm.
clinical trial results may not meet the level of statistical significance required by the FDA or other regulatory authorities;
the FDA or similar foreign regulatory authorities may find that one or more of our products is not sufficiently safe for investigational use in humans or may interpret data from preclinical testing and clinical trials in different ways than we do;
the FDA or similar foreign regulatory authorities may interpret data from preclinical testing and clinical trials in different ways than we do;
we may have trouble in managing multiple clinical sites;
we may have trouble in managing multiple clinical sites; or may have trouble finding patients to enroll in our clinical trials;
we may experience delays in agreeing on acceptable terms with third-party research organizations and clinical trial sites that may help us conduct the clinical trials; and we, or regulators, may suspend or terminate our clinical trials because the participating patients are being exposed to unacceptable health risks.
Medical devices are increasingly connected to the internet, hospital networks, and other medical devices to provide features that improve healthcare and increase the ability of healthcare providers to treat patients and patients to manage their conditions. WhileAlthough currentlydisabled, our RxSight system is capable of bidirectional connectivity and interoperability of our RxSight system with other devices, local networks and the internetinternet, iswhich notif enabled, this may change in the future. Enablement of such features may increase cybersecurity risks and the risks of unauthorized access and use by third parties. For example, unauthorized third parties may seek to access our devices or other products and services, or related devices, products, and services, and modify or use them in a way inconsistent with our FDA clearances and approvals, which may create risks to users and potential exposure to the company.
Our IT systems, contractors or consultants or potential future collaborators, may fail or suffer actual or suspected security or privacy breaches or incidents or other unauthorized or improper access to, use of, or destruction of our proprietary or confidential data, employee data, or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm our brand and cause material disruption to our operations.
We may experience a significant disruption in our information technology systems or breaches of data security.
For example, as previously disclosed,disclosed onin May 2, 2024, an unauthorized actor targeted the personal cell phone number of an RxSight employee. On May 3, 2024, theThe unauthorized actor obtained unauthorized access to the employee’s cloud-based work accountaccount, and to e-mails and files that were accessible from that account. We discovered the incident on the same day, May 3, 2024, promptly disabled the employee’s account, initiated responseday and investigationwere procedures, contacted our insurance provider, and retained external cybersecurity expertsable to assistprevent in our response and investigation. While the unauthorized actor accessed and acquired copiesinterruption of e-mail messages and other materials that were accessible from the employee’s cloud-based work account, our information systems were never interruptedsystems, and they remained operational during this unauthorized access,access. andThis weincident havedid not observed any aspect of this incident that has hadhave a material impact on our operations, financial systems, or financial condition. However, there can be no assurance asthat toa whether thesimilar incident willwould not have a future material impact on our operations, financial systems, or financial condition and we remain subject to various risks due to the incident.
We maintain information security tools and technologies, staff, policies and procedures for managing risk to our networks and information systems, and conduct employee training on cybersecurity designed to mitigate persistent and continuously evolving cybersecurity threats. Our network security controls are comprised of administrative, physical and technical controls, which include, but are not limited to, the implementation of firewalls, anti-virus protection, patches, log monitors, routine backups, off-site storage, network audits and other routine updates and modifications. We also routinely monitor and develop our internal information technology systems to address risks to our information systems. Any system failure, accident or security breach or incident could result in disruptions to our business processes, network degradation, and system down time, along with the potential that a third-party will gain unauthorized access to, acquire, or otherwise use, modify, or process intellectual property, proprietary business information, and data related to our employees, customers, suppliers, and business partners, including personal data, in an unauthorized manner. Any disruption, degradation, or other security breach, incident, or other event that results in loss or unavailability of or damage to our data or systems, system downtime or other disruptions, or in inappropriate disclosure or other processing of confidential or personal data, could adversely impact us and our customers, potentially resulting in, among other things, financial losses, loss of customers or business, our inability to transact business, adverse impact on our reputation, actual or alleged violations of applicable privacy, data protection, security and other laws, regulatory fines, penalties, litigation, reputational damage, reimbursement, or additional compliance and regulatory costs. We may also incur additional costs related to cybersecurity risk management and remediation. There can be no assurance that we or our service providers, if applicable, will not suffer losses relating to cyber-attacks or security breaches or incidents in the future or that our insurance coverage will be adequate to cover all the costs resulting from such events. No assurances can be given that our efforts to reduce the risks of, or to detect, such attacks, breaches or incidents that occur will be successful and our failure to do so could have a material adverse effect on our business, financial condition and results of operations.
Despite the implementation of security measures in our efforts to protect systems that store our information, given their size and complexity and the increasing amounts of information maintained on our internal information technology systems and external processing and storage systems (e.g., hosting), contractors and consultants and other third-party service providers, these systems are potentially vulnerable to breakdown or other damage or interruption. Our systems and the systems of third parties who support our operations are vulnerable to service interruptions, system malfunction, natural disasters, terrorism, war (such as the ongoing conflicts in the Middle East and between Ukraine and Russia) and telecommunication and electrical failures, as well as security breaches and incidents arising from or caused by inadvertent or intentional actions by our employees, contractors, consultants, business partners, and/or other third parties, or from cyber-attacks by malicious third parties (including the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability of information), which may compromise our system infrastructure or lead to unauthorized access to or disruption of our or third-party systems used in our business and the unauthorized access to, misuse, disclosure, loss, destruction, alteration or dissemination of, or damage to, our data, including trade secrets or other confidential information, intellectual property, proprietary business information, and personal information. For example, companies have experienced an increase in phishing and social engineering attacks from third parties in recent years. Our employees generally work in a hybrid model in our offices and from home, and we may need to adjust our working model from time to time. As a result, we have increased cyber-security and data security risks, due to increased use of home wi-fi networks and virtual private networks, as well as increased disbursement of physical machines.
Any disruption, security incident, or security breach resulting in any loss, destruction, unavailability, alteration or dissemination of, or damage to, our data, could subject us to significant fines or penalties for any noncompliance with certain state, federal and/or international laws relating to privacy, data protection, and information security. Litigation and governmental investigations could force us to spend money in defense or settlement, divert management’s time and attention, increase our costs of doing business, and/or adversely affect our reputation. There can be no assurance that we or our service providers, if applicable, will not suffer losses relating to cyber-attacks or security breaches or incidents in the future or that our insurance coverage will be adequate to cover all the costs resulting from such events. No assurances can be given that our efforts to reduce the risks of, or to detect, such attacks, breaches or incidents that occur will be successful and our failure to do so could have a material adverse effect on our business, financial condition and results of operations.
The medical device industry is characterized by rapid technological change and innovation. New technologies, techniques or products could emerge that might offer better combinations of price and performance or better address customer requirements as compared to our current or future products. Competitors, who may have greater financial, marketing and sales resources than we do, may be able to respond more quickly and effectively than we can to new or changing opportunities, technologies, standards or customer requirements. Any new product we identify for internal development, licensing or acquisition may require additional development efforts prior to commercial sale, including extensive clinical testing and approval or clearance by the FDA and applicable foreign regulatory authorities. Due to the significant lead time and complexity involved in bringing a new product to market, we are required to make a number of assumptions and estimates regarding the commercial feasibility of a new product. These assumptions and estimates may prove incorrect, resulting in our introduction of a product that is not competitive at the time of launch. We anticipate that we will face increased competition in the future as existing companies and competitors develop new or improved products and as new companies enter the market with new technologies. Our ability to mitigate downward pressure on our selling prices will be dependent upon our ability to maintain or increase the value we offer to doctors as well as payors. All new products are prone to the risks of failure inherent in medical device product development, including the possibility that the product will not be shown to be sufficiently safe and effective for approval or clearance by regulatory authorities. In addition, wethere cannotis assureno youassurance that any such products that are approved or cleared will be manufactured or produced economically, successfully commercialized or widely accepted in the marketplace. The expenses or losses associated with unsuccessful product development or launch activities, or a lack of market acceptance of our new products, could adversely affect our business, financial condition and results of operations.
Any product we identify, license or acquire may require additional development efforts prior to commercial sale, including extensive clinical testing and approval or clearance by the FDA and applicable foreign regulatory authorities. All products are prone to the risks of failure inherent in medical device product development, including the possibility that the product will not be shown to be sufficiently safe and effective for approval or clearance by regulatory authorities. In addition, wethere cannotis assureno youassurance that any such products that are approved or cleared will be manufactured or produced economically, successfully commercialized or widely accepted in the marketplace.
Although we currently have no agreements or commitments to complete any such transactions, weWe may in the future seek to acquire or invest in businesses, applications or technologies that we believe could complement or expand our portfolio, enhance our technical capabilities or otherwise offer growth opportunities. However, wethere cannotis assureno youassurance that we would be able to successfully complete any acquisition we choose to pursue, or that we would be able to successfully integrate any acquired business, product or technology in a cost-effective and non-disruptive manner. The pursuit of potential acquisitions may divert the attention of management and cause us to incur various costs and expenses in identifying, investigating and pursuing suitable acquisitions, whether or not they are consummated. We may not be able to identify desirable acquisition targets or be successful in entering into an agreement with any particular target or obtain the expected benefits of any acquisition or investment.
In both U.S. and non-U.S. markets, our ability to successfully commercialize and achieve market acceptance of our products depends, in significant part, on the availability of adequate financial remuneration to doctor practices and surgical centers. This remuneration can come from a combination of sources, including third-party payors, such as Medicare and Medicaid programs in the United States,U.S., managed care organizations and private health insurers. Third-party payors decide which treatments they will cover and establish reimbursement rates for those treatments. They also can preclude patients from paying extra to receive additional services, such as those associated with placement of premium IOLs. OurDepending on the country or region, our products are purchased by doctors who will then seek reimbursement from third-party payors and patients for the procedures performed using our products. Reimbursement systems and patient billing rules in international markets vary significantly by country and by region within some countries, and reimbursement and/or non-reimbursement approvals must be obtained on a country-by-country basis. In certain international markets, a product must be approved for reimbursement before it can be approved for sale in that country. Furthermore, many international markets have government-managed healthcare systems that control reimbursement for new devices and procedures, as well as the ability to charge patients directly for non-reimbursed devices and procedures. In most markets there are private insurance systems as well as government-managed systems.
While third-party payors in certain countries and regions currently cover and provide reimbursement for a portion of the cost of the procedures performed using our currently cleared or approved products, wethere can giveis no assurance that these third-party payors will continue to provide coverage and adequate reimbursement or permit patient payment for the non-reimbursed portion sufficient to permit doctors to offer procedures using our products to patients requiring treatment. If sufficient coverage and reimbursement or flexibility to enable patient payment is not available for the procedures performed using our products, in either the United StatesU.S. or any international markets we enter, the demand for our products and our revenue will be adversely affected.
Third-party payors are also increasingly examining the cost effectiveness of products, in addition to their safety and efficacy, when making coverage and payment decisions. Third-party payors have also instituted initiatives to limit the growth of healthcare costs using, for example, price regulation or controls and competitive pricing programs. Some third-party payors also require demonstrated superiority, on the basis of randomized clinical trials, or pre-approval of coverage, for new or innovative devices or procedures before they will reimburse healthcare providers who use such devices or procedures. Additionally, no uniform policy for coverage and reimbursement exists in the United States,U.S., and coverage and reimbursement can differ significantly from payor to payor. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement rates, but also have their own methods and approval process apart from Medicare determinations. It is uncertain whether our current products or any planned or future products will be viewed (or continue to be viewed) as sufficiently cost effective to warrant coverage and adequate reimbursement levels for procedures using such products in any given jurisdiction.
substantial monetary awards to clinical trial participants or patients;
Sales of our products outside of the United StatesU.S. would be subject to foreign regulatory requirements governing clinical trials and marketing approval. We will incur substantial expenses in connection with our international expansion. Additional risks related to operating in foreign countries include:
workforce uncertainty in countries where labor unrest is more common than in the United StatesU.S.;
Management's Discussion & Analysis (MD&A)
New heading “Comparison of the years ended December 31, 2025 and 2024”
Removed heading “Comparison of the years ended December 31, 2023 and 2022”
Removed heading “Recent Developments”
Removed heading “Shelf Registration Statement”
Removed heading “Public Offering”
Removed heading “November 2024 lease activity”
Removed heading “100 Columbia lease to include 120 Columbia Suites 300, 400 and 500”
Removed heading “April 2024 lease activity”
Removed heading “Standby letter of credit”
Largest changes
“We believe this business model provides an attractive and concentrated market opportunity addressable with a focused sales force. Our commercial organization includes LDD sales personnel, LAL account managers, clinical specialists, field service engineers, and marketing personnel. We recently completed a full realignment of our U.S. commercial organization by integrating our clinical and sales teams into a single unified Customer Success Organization. …”see in full comparison
“100 Columbia lease to include 120 Columbia Suites 300, 400 and 500”see in full comparison
“Our sales consist of LALs used in cataract surgeries, the LDDs for delivering light to the LALs to adjust the lens post-surgery, as needed, and service and accessories. Revenue is derived from sales of products mainly in the U.S. and select international markets. Customers are primarily comprised of ophthalmic practices (LDD sales) and ambulatory surgery centers (LAL sales). We recently completed a full realignment of our U.S. commercial organization by integrating our clinical and sales teams into a single unified Customer Success Organization. …”see in full comparison
“Our results are influenced by several key factors, including: (i) growth in our LDD installed base, which enables LALs to be implanted; (ii) the utilization of that installed base for LAL procedures, measured by the number of LALs implanted per installed LDD; (iii) product mix between LALs and LDDs, which affects our overall gross margins; (iv) manufacturing cost trends; and (v) seasonal and external factors that may affect cataract surgery volumes. …”see in full comparison
Full comparison: every changed paragraph (65)
WeRxSight, areInc. is a commercial-stage medical technology company dedicated to providing high qualityhigh-quality customized vision to patients following cataract surgery. Our proprietary RxSight® Light Adjustable Lens system (“RxSight system”) is the first and only commercially available premium cataract technology that enables doctors to customize and optimize visual acuity for patients after surgery. The RxSight system is comprised of our RxSight Light Adjustable Lens™® (“LAL™” and “®/LAL+®”, collectively the “LAL”), RxSight Light Delivery Device™ (“LDD™”), and related accessories. OurThe LAL'sLAL areis a premium intraocular lens (“IOL”) made offrom the proprietary silicone-based photosensitive material that undergoes controlled changes shape in responserefractive power when exposed to specific patterns of ultraviolet (“UV”) light patterns generated by ourthe LDD.
We designed our RxSight system to address the shortcomingslimitations of competitiveconventional premium IOL technologies andby provideproviding doctors with a solutionmore thatprecise doctorsand canadaptable trustmethod tofor improveachieving desired visual outcomes andfor achievetheir highpatients. levels of patient satisfaction. CompetitiveConventional premium IOLs require patients to specifyselect their visual priorities before surgery and be willing to accept variousthe optical trade-offs associatedinherent within those choices. Once a patient has selected a competitive premium IOL, the surgeonSurgeons must rely on a series of preoperative diagnostic testsmeasurements and predictive formulae to choosedetermine the appropriate lens power. If the doctor’sselected predictionpower isn’tis exact,not optimal, the patient may experience suboptimalless-than-ideal results that could necessitaterequire a subsequent corneal refractive procedure or certain other compromisescorrective in ordermeasures to reachachieve intended vision targets.
In contrast, with the RxSight system, the surgeon implants the LAL duringas athey standardwould in any other cataract procedure, determines refractive error with patient input several weeks following surgery and then uses the LDD to modify the LAL with the precise visual correction needed to achieve the patient’s desired vision outcomes. We believe our RxSight system provides doctors and patients increased confidence and peace of mind by eliminating the high-stakes preoperative guesswork common to competitiveconventional premium IOLs and allowing patients to iterate their final vision characteristics with customized post-surgical adjustments.
WeCurrently, we primarily compete primarily in the IOL market in the U.S. The LAL is a premium IOL which is partially reimbursable under Medicare, and in some cases by private payors. Premium IOLs are sold at a higher price point than conventional IOLs,IOLs as they provide refractive correction of vision unlikecorrection, awhereas conventional IOLIOLs thatsimply only replacesreplace the natural lens with a clear lens (which is the standard for Medicare reimbursement). Our RxSight system hasis regulatoryapproved in the U.S. and several foreign countries for improving uncorrected visual acuity by adjusting the LAL power to correct residual postoperative refractive error. Outside of the U.S., we presently have approval in the U.S., Europe, Canada, MexicoMexico, Singapore, Australia and Korea.South WeKorea, mayand selectivelywe pursueintend commercialto expansionseek in these or other geographies that accept theseadditional approvals in the future,future to broaden our international presence. In non-U.S. markets, reimbursement and healthcare payment systems vary significantly by country. Some have instituted price ceilings on specific products and therapies. In many countries, analogous determinations to the dual aspect CMS ruling have been made, allowing for partial coverage of the cataract procedure by national health systems, with apatients prioritypaying onout marketsof wherepocket for refractive services associated with the premium IOL. In other countries, similar dual billing is not allowed. While we seeare significantgrowing potentialour opportunities.presence Newoutside approvalsthe mayU.S., alsowe bedo soughtnot inanticipate largemeaningful foreignnear-term cataractsales marketsfrom withthese morenon-U.S. complex regulatory processes such as Asia and Europe.regions.
We are a Delaware corporation headquartered in Aliso Viejo, California with onetwo wholly owned subsidiarysubsidiaries located in Hong Kong (“RxSight, Hong Kong”) and in Amsterdam, Netherlands.Netherlands The(“RxSight, whollyNetherlands”). ownedRxSight, subsidiaryNetherlands has a registered branch in the United Kingdom and a wholly owned subsidiary located in Germany.Germany (“RxSight Germany”).
Our commercial efforts began in late 20192019, and have been primarily focused in the United States,U.S., where we are building a “razor and razor blade” business model to drive new customer adoption and ongoing LAL volume growth. Our United States commercial organization includes a direct sales team of LDD sales personnel and LAL account managers, as well as clinical specialists, field service engineers and marketing personnel. Our sales efforts are concentrated on the roughlyapproximately 3,500 to 4,000 U.S. cataract surgeons that perform approximately 60% of all premium IOL procedures. As of December 31, 2024,2025, we hadhave established an installed base of 9711,134 LDDs in ophthalmology practices and, since our inception thoughthrough December 31, 2024,2025, surgeons have implanted overapproximately 195,000300,000 LALs.
We believe this business model provides an attractive and concentrated market opportunity addressable with a focused sales force. Our commercial organization includes LDD sales personnel, LAL account managers, clinical specialists, field service engineers, and marketing personnel. We recently completed a full realignment of our U.S. commercial organization by integrating our clinical and sales teams into a single unified Customer Success Organization. We believe this new structure will not only help us better support our existing customers, but it will also position us for the next phase of adoption. Each integrated team within the Customer Success Organization is responsible for a defined group of doctors and practices, managing the customer experience from onboarding through long-term LAL utilization growth. The majority of employees in our approximately 200-person commercial organization are in the Customer Success Organization. We plan on growing our business by increasing LAL adoption, expanding our LDD installed base, and driving heightened awareness of what we believe to be superior clinical outcomes that our RxSight system provides patients. We have found that ensuring clinicians understand our technology, are well-trained in its use, and understand the number of patients our technology can benefit, increases utilization. Our Customer Success Organization is focused on providing this support to our customers.
We believe this business model provides an attractive and concentrated market opportunity addressable with a focused sales force. We intend to continue to make significant investments in our sales and marketing organization. We believe selectively increasing the number of sales representatives, practice development personnel and clinical trainers will help facilitate further adoption of our products among existing customer accounts as well as broaden awareness of our products to new accounts. We plan to grow our business primarily by expanding the size of our LDD installed base and driving increased utilization of our LAL through heightened awareness of the superior clinical outcomes that our RxSight system provides patients. To continue to strengthen our competitive position in the premium IOL market, our research and development activities are focused primarily on programs that improve clinical outcomes, improve customer experience, expand our indications for use, reduce manufacturing costs and lifecycle management. Our near-term research and development activities are focused on enhancements to the RxSight system to improve theclinical patientoutcomes, andenhance doctorcustomer experience, expand the range of patients that can be treated, as well as expand the RxSight systemour indications for use, reduce manufacturing costs and drivesupport adoption.lifecycle management. We believe that over time, our adjustable lens solution can be used to address a broad range of cataract surgery patients, including those that would otherwise elect for a conventional cataract procedure today. AdditionalWe developmentwill andundertake additional clinical studies that are designed to provideexpand clinicalthe existing body of evidence ofrelated to the safety and effectiveness of our existingcurrent and future generations of products are also anticipated.products. Finally, we may in the future seek to acquire or invest in additional businesses, products or technologies that we believe could complement or expand our portfolio, enhance our technical capabilities or otherwise offer growth opportunities.
While we continue to make investments in our sales and marketing organization, including personnel in clinical applications, practice development, sales and technical service personnel, we also intend to expand our marketing efforts through additional print and digital, social media, education and other customer tools to drive further adoption of the RxSight system.
We intend to continue to make investments in our sales and marketing organization, primarily sales representatives, clinical applications specialists and technical service personnel to support new customers and upgrades and LAL account managers to facilitate adoption of use of our LALs among existing accounts. We will expand our marketing efforts with additional print and digital, social media and other customer tools to expand their local advertising. We will also continue to make significant investments in research and development and clinical expenses to make enhancements in our current products. Additionally, as a public company, we have incurred and expect to continue to incur increased costs forrelated employee-relatedto expenses,operating as a public company, such as director and officer insurance premiums, audit fees, (including costs for compliance with Section 404(b) of the Sarbanes-Oxley Act),Act, legal fees, investor relations fees, fees to members of our Board of directorsDirectors, and expenses for compliance with public-company reporting requirements. Because of our ongoing investment in our business and products and these and other factors, we expect to continue to incur net losses and negative cash flows from operations infor the near future.
We regularly review several operating and financial metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate our business plan and make strategic decisions.
Our results are influenced by several key factors, including: (i) growth in our LDD installed base, which enables LALs to be implanted; (ii) the utilization of that installed base for LAL procedures, measured by the number of LALs implanted per installed LDD; (iii) product mix between LALs and LDDs, which affects our overall gross margins; (iv) manufacturing cost trends; and (v) seasonal and external factors that may affect cataract surgery volumes. We believe the number of LDDs installed and LALs implanted are the strongest indicators of the adoption of our technology and our ability to generate revenue. We monitor average monthly utilization, which we define as the number of LALs implanted during a quarter divided by the LDD installed base at the end of the prior quarter. This fluctuates due to seasonality, practice ramp, and external disruptions (including severe weather events).
We regularly review several operating and financial metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate our business plan and make strategic decisions. We believe the number of LDDs installed and, LALs implanted are indicators of our ability to drive adoption and generate revenue. We believe these are important metrics for our business. We may not yet be able to accurately assess seasonality and other trends, and we will continue to evaluate our business in the future using these and other financial metrics as we observe trends in our business. Our quarterly and annual financial results may fluctuate as a result of a variety of factors many of which are outside our control. For example, it is not uncommon in our industry to experience seasonally weaker sales during the summer months and end-of-year holiday season. We may be affected by other seasonal trends in the future, including severe weather (which can impact the number of elective procedures performed), particularly as our business matures. Additionally, this seasonality may be reflected to a much lesser extent, and sometimes may not be immediately apparent, in our revenue. To the extent we experience this seasonality, it may cause fluctuations in our operating results and financial metrics and make forecasting our future operating results and financial metrics more difficult.
We believe the number of LDDs sold in each quarter and our LDD installed base at the end of each period are important metrics as they represent an installed base into which we can sell our LALs. We also believe the number of LALs sold (reported as implanted in a patient) in each quarter is an important metric indicative of adoption and utilization of our RxSight system.
During 2024,2025, we hadsold increased163 LDDLDDs, saleswhich was a decrease of 39142 and increased LAL sales of 43,182LDDs when compared to 2023the fromprior strongyear due to slower adoption of our RxSight technology by practices and doctorsdoctors. combinedLAL with ansales increased by 11,560 units when compared to the prior year, primarily due to the larger LDD installed base.
Our sales consist of LALs used in cataract surgeries, the LDDs for delivering light to the LALs to adjust the lens post-surgery, as needed, and service and accessories. Revenue is derived from sales of products mainly in the U.S. and select international markets. Customers are primarily comprised of ophthalmic practices (LDD sales) and ambulatory surgery centers (LAL sales). We recently completed a full realignment of our U.S. commercial organization by integrating our clinical and sales teams into a single unified Customer Success Organization. Each integrated team within the Customer Success Organization is responsible for a defined group of doctors and practices, managing customer experience from onboarding through long-term LAL utilization growth. Following several years of rapid growth, sales moderated in 2025, and we expect our commercial realignment initiatives to position the company for renewed revenue growth. We plan to drive continued expansion by supporting existing practices and strategically expanding our LDD installed base and helping new adopters in achieving early success and sustained long-term growth.
Our sales consist of the sale of LALs used in cataract surgeries, the LDDs for delivering light to the LALs to adjust the lens post-surgery, as needed, and service and accessories. Revenue is derived from sales of products primarily in the United States. Customers are primarily comprised of ophthalmic practices (LDD sales) and ambulatory surgery centers (LAL sales). We expect revenue to increase in absolute dollars as we expand our sales organization and sales territories, add customers, expand the base of doctors that are trained to use our products, and expand awareness of our products with new and existing customers and as doctors perform more procedures using our products.
In the U.S. LALs are held at customer sites on consignment. Revenue is recognized for LALs upon customer notification that the LALs have been implanted in a patient. Outside the U.S., generally, LALs are held at distributor sites and distributor customer locations, with revenue recognized for LALs upon the distributor notification that the LALs have been implanted in a patient or upon shipment to the distributor.
Our LDD contracts contain multiple performance obligations bundled into one transaction price, with all obligations generally satisfied within one year. TheRevenue for the LDD capital asset and related components revenue is recognized uponat a point in time either at installation and customeracceptance acceptance,or upon shipment to our international distributors. Revenue for training revenue is recognizedalso upon completion of training byrecorded at leasta onepoint doctorin andtime, generally 60 days after installation. Revenue for the initial warranty anddevice service agreement areis recognized ratably over thetime serviceafter period.installation, generally 12 months. After the first year, service contracts can be purchased separately on a standalone basis. Revenue for such service agreements will be recognized ratably over the term of each contract.
Cost of sales consist of materials, labor and manufacturing overhead internally to produce our products as well as the cost of shipping and handling. Overhead costs include the cost of quality assurance, material procurement, inventory control, facilities, equipment and operations supervision and management and stock-based compensation. Cost of sales also includes depreciation expense for production equipment and certain direct costs such as shipping costs and royalty and license fee expense.costs. Shipping costs billed to customers are included in sales. WeAs we return to growth, we expect cost of sales to increase in absolute dollars as our revenue grows and morehigher volume of our products are sold.
We calculate gross margin as gross profit/(loss) divided by sales. Our gross margin has been and will continue to be affected by a variety of factors, including average selling prices, product sales mix, production and ordering volumes, manufacturing costs, product yields, headcount and cost-reduction strategies. Our gross margin could fluctuate from quarter to quarter as we introduce new products, increase or decrease units of production for both the LDD and LAL and as we adopt new manufacturing processes and technologies.
Our LDD, as is typical of many medical device capital equipment products, has a lower gross margin than the IOL,margin, as the material cost of the LDD is significant,a representingsignificant approximately 50%portion of the total cost to manufacture. In addition, thewe listdo pricenot formark and average selling price ofup our LDD are priced reasonablysubstantially because LDDs, once sold, can generate LAL procedures. Our LAL gross margin is higher, with low material cost but high fixed overhead costs. As our manufacturing volume of the LAL increases and the percentage of revenue from the LAL increases as a percentage of sales, we expect gross margin may continue to improve.
Selling, general and administrative (“SG&A”), expenses consist primarily of personnel-related expenses, including wages, incentive bonuses, stock-based compensation and benefits related to administrative, selling and marketing functions, education programs for doctors, commercial operations and analytics, finance, information technology and human resource functions. Other SG&A expenses include sales commissions, travel expenses, promotional activities, marketing initiatives, market research and analysis, conferences and trade shows, training for doctors, professional services fees such as legal, patent registration costs, accounting, audit fees,fees (including costs for compliance with Section 404(b) of the Sarbanes-Oxley Act), tax fees, board of directors’ expenses, insurance costs, general corporate expenses and facilities-related expenses. We expect SG&A expenses to continue to increase in absolute dollars as we expand our sales and marketing organization and infrastructure to both drive and support the anticipated growth in revenue.
Interest expense consist primarily of interest incurred on leases.
Interest expense consist primarily of interest incurred on indebtedness and non-cash interest related to the amortization of debt discount and issuance costs associated with our indebtedness and interest on leases.
Loss on extinguishment of term loan consist of the loss from extinguishment of term loans due to repayment to Oxford Finance, LLC (“Oxford”). For more information regarding our prior term debt arrangement with Oxford, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) – Liquidity and Capital Resources – Refinancing and Payoff of Oxford Debt” in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 28, 2024 (the “2023 Form 10-K”), which is incorporated herein by reference.
Comparison of the years ended December 31, 2025 and 2024
The following table summarizes our results of operations for the years ended December 31, 2025 and 2024, together with the dollar increase or decrease and percentage change in those items:
Sales decreased by $5.5 million, or (3.9)%, to $134.5 million in 2025 from $139.9 million in 2024. The decrease in total sales was primarily due to a decline of 142 units, or (47%), in the total number of LDDs sold during the year ended 2025 as compared to the same period in 2024. The lower LDD sales were partially offset by increased LAL sales of 11,560 units, or 12%, when compared to the same period in 2024, which was primarily due to the net increase in our LDD installed base. The reduction in LDD sales was due to slower adoption of RxSight technology among practices and doctors in 2025 as compared to 2024.
Cost of sales decreased by $9.5 million, or (23.2)%, to $31.5 million for the year ended December 31, 2025 from $41.0 million for the year ended December 31, 2024, primarily due to the decreased number of LDDs sold during the period. Gross margin increased to 76.6% in 2025 from 70.7% in 2024, primarily due to favorable product mix from a greater percentage of revenue from LAL sales, with LAL revenue comprising 80% of revenue in 2025, compared to 69% of revenue in 2024.
Selling, general and administrative expenses increased by $11.2 million, or 11.1%, to $112.7 million in 2025, from $101.4 million in 2024. This increase was primarily attributable to an increase in selling and marketing costs of $10.0 million, personnel costs of $1.9 million, $2.4 million of increased stock-based compensation expense, $3.9 million in additional marketing study costs, and $1.7 million in new customer acquisition costs, in each case when compared to 2024. General and administrative expenses increased by $1.2 million due to increased stock-based compensation of $1.7 million, which was partially offset by decreases in personnel costs of $0.5 million, primarily due to lower bonus accruals and headcount. We expect selling, general and administrative expenses to continue to expand as we increase our research and development activities, build out our marketing, sales and clinical teams in the U.S. and outside the U.S., and otherwise grow our business.
Research and development expenses increased by $4.1 million to $38.5 million in from $34.4 million in 2024, an increase of 12.2%. This increase was primarily attributable to $2.6 million in research and development activities, including the allocation of manufacturing resources and headcount, $2.7 million in increased personnel costs which includes stock-based compensation, offset by a $1.3 million decrease in clinical study and other costs. We expect to maintain our focus on research and development spending as we seek to improve clinical outcomes, improve customer experience, expand our indications for use, reduce manufacturing costs and support lifecycle management.
Other income (expense), net decreased by $0.2 million to income of $9.3 million in 2025 from income of $9.5 million in 2024. This change was primarily due to lower interest rates on investment balances in 2025 as compared to 2024.
The following table summarizes our results of operations for the years ended December 31, 2024 and 2023, together with the dollar increase or decrease and percentage change in those items:
Sales increased by $50.8 million, or 57.1%, to $139.9 million for the year ended December 31, 2024 from $89.1 million for the year ended December 31, 2023. The increase was due to incremental sales of 43,182 LALs primarily due to continued penetration in existing customers, an increased LDD installed base of 305 and incremental sales of 39 LDDs from strong adoption of our RxSight technology by practices and doctors.
Cost of sales increased by $5.7 million, or 16.1%, to $41.0 million for the year ended December 31, 2024 from $35.3 million for the year ended December 31, 2023, primarily due to the increase in the number of LALs and LDDs sold during the period. Gross margin increased to 70.7% in the year ended December 31, 2024 from 60.4% in 2023 primarily due to improved operating leverage, favorable product mix from a greater percentage of revenue from LAL sales and increased margins on our LDD due to lower material costs from the introduction of our compact LDD during the third quarter of 2023.
Selling, general and administrative expenses increased by $26.6 million, or 35.6%, to $101.4 million for the year ended December 31, 2024, from $74.8 million for the year ended December 31, 2023. This increase was primarily attributable to an increase in selling and marketing personnel costs of $19.4 million due mainly to additional headcount of 44, increased sales commissions, incentive bonuses and employee benefits of $9.4 million, $3.2 million of increased stock-based compensation expense, $3.7 million in additional marketing study costs, and new customer acquisition costs, in each case when compared to the year ended December 31, 2023. General and administrative expenses increased by $7.2 million due to increased personnel expenses of $2.6 million, and increased stock-based compensation of $2.8 million and as well as $1.6 million of increased sales tax, outside services, software licenses and bank fees due to an increase in our general administration infrastructure to support an increased installed base and revenues.
Research and development expenses increased by $5.3 million to $34.4 million for the year ended December 31, 2024 from $29.1 million for the year ended December 31, 2023, an increase of 18.3%. This increase was primarily attributable to $2.9 million in increased facility costs due to increased research and development infrastructure, $2.2 million in increased personnel costs which includes stock-based compensation and $0.4 million in increased clinical study costs.
Other income (expense), net increased by $8.0 million to income of $9.5 million for the year ended December 31, 2024 from income of $1.5 million for the year ended December 31, 2023. This change was primarily due to increased interest income of $2.9 million primarily from higher short-term investment balances and decreased interest expense of $3.3 million on the Oxford term loan and a decrease of $1.8 million loss from extinguishment of term loan due to the repayment of the Oxford debt.
Comparison of the years ended December 31, 2023 and 2022
As of December 31, 2024,2025, we had cash and cash equivalents of $16.7$19.9 million, short-term investments of $220.5$208.2 million, and accumulated deficit of $622.1$661.0 million. For the years ended December 31, 20242025 and 2023,2024, our net losses from operations were $36.9$48.2 and $50.1$36.9 million, respectively. We generated sales of $139.9$134.5 million and had a net loss of $27.5$38.9 million forin the year ended December 31, 2024,2025, compared to sales of $89.1$139.9 million and net loss of $48.6$27.5 million forin the year ended December 31, 2023.2024.
Recent Developments
Shelf Registration Statement
On May 8, 2024, we filed an automatic shelf registration statement on Form S-3 (“shelf registration statement”). The shelf registration statement is effective for three years and permits us to sell, from time to time, common stock, preferred stock, debt securities, warrants, and/or units. The shelf registration statement is intended to provide us with the flexibility to access additional capital. At the time of filing the shelf registration statement, we also filed a prospectus supplement to sell up to an aggregate value of $115.0 million dollars of common stock through a public offering (“Public Offering”).
Public Offering
On May 8, 2024, we entered into an underwriting agreement with BofA Securities, Inc., in which we agreed to issue and sell 1,785,714 shares of our common stock in a Public Offering, pursuant to the shelf registration statement. The shares of common stock were sold at a price to the public of $56.00 per share. Under the terms of the underwriting agreement, we also granted the underwriters an option exercisable for 30 days from the date of the underwriting agreement to purchase up to an additional 267,857 shares of common stock on the same terms and conditions. The underwriters' option was exercised in full on May 10, 2024 and the Public Offering (inclusive of the underwriters' option shares) closed on May 13, 2024. We received net proceeds of approximately $107.5 million from the Public Offering, after deducting underwriters' discounts and commissions of $6.9 million and other offering expenses of $0.6 million.
November 2024 lease activity
100 Columbia lease to include 120 Columbia Suites 300, 400 and 500
On November 6, 2024, we entered into a new lease amendment to one of our existing leases comprising our headquarters, manufacturing, research and development and administrative offices in Aliso Viejo, California. We entered into the new amended lease to have continued long-term access to our facilities and acquire additional square footage.
April 2024 lease activity
On April 18, 2024, we entered into a new lease, and amendments to two existing leases, for three of our four facilities comprising our headquarters, manufacturing, research and development and administrative offices in Aliso Viejo, California. We entered into the new lease and amended two existing leases to extend the rental terms and options, ensure continued long-term access to our facilities, acquire additional square footage to expand manufacturing, and align the lease end dates for each of our four facilities. See Note 11 – Leases in the Notes to the consolidated financial statements included in this report.
Our four facility operating leases are our only material contractual obligations. For ana additional descriptiondiscussion of theseour contractual obligations and commitments, seerefer to Part II, Item 8, Note 1112, –“Commitments Leasesand Contingencies” in theour Notesnotes to the consolidated financial statements included in this annualAnnual report.Report on Form 10-K.
Standby letter of credit
Our standby letter of credit was not required to be renewed and expired on September 30, 2024.
As of December 31, 2024,2025, we had cash and cash equivalents of $16.7$19.9 million,million and short-term investments of $220.5 million, and an accumulated deficit of $622.1$208.2 million. We believe that our current cash, cash equivalents and short-term investments through the date of filing of this report will be sufficient to fund our operations for at least the next 12 months. Although, based on our current planned operations, we do not anticipate the need to raise additional capital or incur additional debt in order to reach profit from operations, as the same may be disclosed in the Company’s future Annual Reports on Form 10-K or Quarterly Reports on Form 10-Q filed with the SEC, we may be required to raise additional capital through public or private equity offerings or debt financings, credit or loan facilities or by entering into partnerships or a combination of one or more of these funding sources in order to meet our liquidity requirements. We may also opportunistically raise capital under advantageous circumstances from time to time, such as the Public Offering, in ordertime to support the expansion of our sales and operations in the U.S. and internationally and to pursue other business opportunities. If we determine that we need to raise additional funds, whichsuch capital may not be available to us when needed or on terms that we deem to be favorable. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If we are unable to maintain sufficient financial resources, our business, financial condition and results of operations will be materially and adversely affected, including potentially requiring us to delay, limit, reduce or terminate certain of our product discovery and development activities or future commercialization efforts. If we raise additional funds by issuing equity securities, our stockholders may experience dilution.
Net cash used in operating activities forin the year ended December 31, 20242025 was $17.0$15.5 million consisting primarily of a net loss of $27.5$38.9 million, a change in operating assets and liabilities of $9.2$4.9 million, partially offset by non-cash stock-based compensation of $24.6$31.6 million, and depreciation and amortization of $3.6$3.3 million.
Net cash used in operating activities forin the year ended December 31, 20232024 was $41.6$17.0 million consisting primarily of a net loss of $48.6$27.5 million, a change in operating assets and liabilities of $9.1$9.2 million, partially offset by non-cash stock-based compensation of $15.7$24.6 million, and depreciation and amortization of $4.1$3.6 million.
Net cash used in investing activities for the year ended December 31, 2024 was $99.3 million, consisting of net purchases of short-term investments of $93.9 million and purchases of property and equipment of $5.4 million.
Net cash usedprovided inby investing activities forin the year ended December 31, 20232025 was $22.1$16.9 million, consisting of net purchasesmaturities of short-term investments of $17.3$20.7 million andoffset by purchases of property and equipment of $4.8$3.8 million.
Net cash used in investing activities in 2024 was $99.3 million, consisting of net purchases of short-term investments of $93.9 million and purchases of property and equipment of $5.4 million.
What changed in the latest 10-Q
Risk Factors
New heading “Risks related to the RxSight-Alcon Collaboration Agreement:”
New heading “We are dependent on our collaboration with Alcon for the development and commercialization of the Collaboration Products, and we have limited control over Alcon’s performance under the collaboration.”
New heading “A substantial portion of the payments contemplated by the RxSight-Alcon Collaboration Agreement is contingent, and the agreement may be terminated before we realize its anticipated benefits.”
New heading “The RxSight-Alcon Collaboration Agreement restricts our ability to develop and commercialize certain competing products and may require us to repay a portion of the amounts we receive from Alcon.”
Largest changes
“The RxSight-Alcon Collaboration Agreement is also subject to termination in a number of circumstances that could prevent us from realizing its anticipated value. The agreement may be terminated by mutual agreement of the parties, and if a mutual termination occurs within the first 120 days following the effective date, we would forfeit a majority or all of the upfront payment. Either party may terminate the agreement for material safety reasons, the other party’s insolvency or violation of applicable law, or an uncured material breach. …”see in full comparison
“We are dependent on our collaboration with Alcon for the development and commercialization of the Collaboration Products, and we have limited control over Alcon’s performance under the collaboration.”see in full comparison
“The RxSight-Alcon Collaboration Agreement restricts our ability to develop and commercialize certain competing products and may require us to repay a portion of the amounts we receive from Alcon.”see in full comparison
“A substantial portion of the payments contemplated by the RxSight-Alcon Collaboration Agreement is contingent, and the agreement may be terminated before we realize its anticipated benefits.”see in full comparison
“Risks related to the RxSight-Alcon Collaboration Agreement:”see in full comparison
“The RxSight-Alcon Collaboration Agreement imposes restrictions on our ability to pursue certain products that we might otherwise choose to develop, manufacture, or commercialize. During the development phase of the Collaboration Products, we are obligated to prioritize the collaboration and development activities contemplated by the agreement, and we are restricted from developing, manufacturing, or commercializing certain defined types of hybrid-material simultaneous vision intraocular lenses that may compete with the Collaboration Products. …”see in full comparison
Full comparison: every changed paragraph (44)
Risks related to the RxSight-Alcon Collaboration Agreement:
We are dependent on our collaboration with Alcon for the development and commercialization of products under the RxSight-Alcon Collaboration Agreement, and we have limited control over Alcon’s performance under the collaboration.
A substantial portion of the payments contemplated by the RxSight-Alcon Collaboration Agreement is contingent, and the agreement may be terminated before we realize its anticipated benefits.
The RxSight-Alcon Collaboration Agreement requires us to prioritize the collaboration and development contemplated by the RxSight-Alcon Collaboration Agreement and restricts our ability to develop and commercialize certain competing products and may require us to repay a portion of the amounts we receive from Alcon.
While sales declined in 2025 and in the first quarterhalf of 2026 following several years of rapid growth, we have implemented changes in our sales organization in an effort to return to revenue growth in absolute dollars. In order to increase LAL use at our current customers, we recently realigned our commercial structure by unifying our LAL sales and clinical support personnel into a single Customer Success Organization. Each team within the Customer Success Organization is responsible for a defined group of doctors and practices, overseeing customer experience from initial onboarding through ongoing efforts to drive long-term utilization growth. Our LDD sales team remains focused on acquiring new high-potential accounts, which are subsequently transitioned to the Customer Success Organization for clinical support, education, and to maximize long-term utilization and growth and LAL use.
We have incurred losses from operations since our inception and expect to continue to incur losses from operations in the future. We reported losses from operations of $48.2 million and $36.9 million for the years ended December 31, 2025 and 2024, respectively, and $17.8 million and $10.7$31.6 million for the threesix months ended MarchJune 31,30, 2026 and 2025, respectively.2026. As a result of these losses, as of MarchJune 31,30, 2026, we had an accumulated deficit of $676.9$689.0 million. We expect to continue to incur significant sales and marketing, research and development, regulatory and other expenses as we expand our marketing efforts to increase adoption of our products, expand existing relationships with our customers, obtain regulatory clearances or approvals for our planned or future products, conduct clinical trials on our existing and planned or future products and develop new products or add new features to our existing products.
As of MarchJune 30, 2026 and December 31, 20262025, we had $217.9$208.8 million and $228.1 million, respectively, in cash, cash equivalents and short-term investments. While we believe that our existing cash, cash equivalents and short-term investments and anticipated cash generated from sales of our products will be sufficient to meet our anticipated cash needs for at least 12 months following the date of this report, there is no assurance you that we will be able to generate sufficient liquidity as and when needed. Further, although we do not anticipate the need to raise additional capital or incur additional debt in order to reach profit from operations, we may opportunistically seek to raise capital under advantageous circumstances from time to time in order to support the expansion of our sales and operations in the U.S. and internationally and to pursue other business opportunities. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned. There is no assurance you that we will be able to generate sufficient liquidity as and when needed.
We are dependent on our collaboration with Alcon for the development and commercialization of the Collaboration Products, and we have limited control over Alcon’s performance under the collaboration.
In June 2026, we entered into a License, Collaboration and Development Agreement (the “RxSight-Alcon Collaboration Agreement”) with Alcon Pharmaceuticals, Ltd (“Alcon”), pursuant to which we agreed to collaborate with Alcon to develop and commercialize light-adjustable versions of certain Alcon simultaneous vision intraocular lenses that incorporate our Light Adjustable Technology™ (the “Collaboration Products”). Under the RxSight-Alcon Collaboration Agreement, Alcon is responsible for commercializing the Collaboration Products, subject to our right to co-promote upon the occurrence of certain triggering events, and following regulatory approval and payment of the applicable milestone, Alcon has agreed to use commercially reasonable efforts to launch each Collaboration Product in the U.S. within a specified period. As a result, the commercial success of the Collaboration Products will depend to a significant extent on Alcon rather than on us.
The efforts and resources that Alcon devotes to the collaboration are largely outside of our control, and Alcon’s obligations may be difficult for us to monitor or enforce. Alcon is a large, diversified ophthalmic company with a broad portfolio of intraocular lenses, including products that may compete with the Collaboration Products, and Alcon may have strategic, financial, or commercial priorities that differ from ours. Alcon may determine the pricing, positioning, promotion, timing, and scope of any launch or commercialization of the Collaboration Products in ways that do not maximize, or that reduce, the royalties and other payments we may receive. In addition, Alcon could undergo a change of control, business combination, or shift in strategic focus that diverts resources away from the collaboration or creates competing priorities.
If Alcon does not perform its obligations as we expect, does not devote sufficient resources to the development or commercialization of the Collaboration Products, elects not to continue the collaboration at the points at which it has discretion to do so, or if a dispute arises between us and Alcon regarding our respective rights and obligations, the anticipated benefits of the collaboration may not be realized, may be delayed, or may cost more than we expect. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
A substantial portion of the payments contemplated by the RxSight-Alcon Collaboration Agreement is contingent, and the agreement may be terminated before we realize its anticipated benefits.
Although Alcon paid us a $60 million upfront payment in connection with executing the RxSight-Alcon Collaboration Agreement, a significant portion of the additional consideration contemplated by the agreement is contingent on future events, and certain of the most significant payments are payable only at Alcon’s election. Alcon has the option, but is not obligated, to make a $70 million Feasibility Milestone Payment upon completion of feasibility activities and achievement of specified technical criteria for the first Collaboration Product, and a $40 million Approval Milestone Payment upon regulatory approval of the first Collaboration Product. If Alcon elects not to make either payment, the RxSight-Alcon Collaboration Agreement will terminate, subject to our retaining certain reversionary rights with respect to the Collaboration Products under specified conditions. The remaining $30 million milestone is payable only upon our first submission to the FDA for regulatory approval of the first Collaboration Product, which is itself subject to substantial development and regulatory risk.
The RxSight-Alcon Collaboration Agreement is also subject to termination in a number of circumstances that could prevent us from realizing its anticipated value. The agreement may be terminated by mutual agreement of the parties, and if a mutual termination occurs within the first 120 days following the effective date, we would forfeit a majority or all of the upfront payment. Either party may terminate the agreement for material safety reasons, the other party’s insolvency or violation of applicable law, or an uncured material breach. Following an initial term measured from regulatory approval of the first Collaboration Product, the agreement is subject to automatic renewal, but Alcon may elect not to renew for any reason, whereas our right to decline renewal is limited to circumstances in which Alcon fails to meet specified sales volumes during a defined period.
As a result of the contingent nature of these payments and the termination and non-renewal provisions described above, we may never receive a substantial portion of the payments contemplated by the RxSight-Alcon Collaboration Agreement, and the payments we do receive may be materially lower, or realized materially later, than we currently anticipate. Any of the foregoing could have a material adverse effect on our business, financial condition and results of operations.
The RxSight-Alcon Collaboration Agreement restricts our ability to develop and commercialize certain competing products and may require us to repay a portion of the amounts we receive from Alcon.
The RxSight-Alcon Collaboration Agreement imposes restrictions on our ability to pursue certain products that we might otherwise choose to develop, manufacture, or commercialize. During the development phase of the Collaboration Products, we are obligated to prioritize the collaboration and development activities contemplated by the agreement, and we are restricted from developing, manufacturing, or commercializing certain defined types of hybrid-material simultaneous vision intraocular lenses that may compete with the Collaboration Products. These restrictions could prevent or delay us from pursuing independent product opportunities, including opportunities that could be more profitable to us than the collaboration or that could better position us against competitors, and could divert our research, development, and manufacturing resources toward the collaboration and away from other programs.
Following the development phase, if we elect, in our discretion, to develop or manufacture certain defined types of competing hybrid-material simultaneous vision intraocular lenses, we would become subject to adverse economic consequences under the agreement. These consequences include a reduction in the royalties payable to us by 60% or more, a suspension of Alcon’s minimum royalty obligations upon commercialization of such products, and, under certain circumstances, an obligation to reimburse Alcon for a portion of the upfront and milestone payments previously received, ranging from a low double-digit to a high double-digit percentage depending on the timing of our commercial release of such products.
The prospect of these consequences may effectively deter us from developing or commercializing competing products even in circumstances where doing so would otherwise be in our commercial interest, and any obligation to reimburse Alcon for previously received payments could arise at a time when we have already deployed those funds, which could have a material adverse effect on our liquidity, business, financial condition and results of operations.
Deterioration in the economic conditions globally has resulted in instability in global financial markets, including: inflation and rising interest rates and instability in the capital markets.
Economic benefits and cost savings to physicians and patients, including those resulting from free or inexpensive products distributed as part of competitive trialing, even if temporary;
Economic benefits and cost savings;
AnyOur collaboration with Alcon, and any collaboration or partnership arrangements that we may enter into in the futurefuture, may not be successful, which could adversely affect our ability to develop and commercialize our products.
AnyIn June 2026, we entered into the RxSight-Alcon Collaboration Agreement, and we may enter into additional collaboration or partnership arrangements in the future. Our existing collaboration with Alcon and any future collaborations that we enter into may not be successful. The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborations are subject to numerous risks, which may include that:
For example, as previously discloseddisclosed, in MayMay, 2024, an unauthorized actor targeted the personal cell phone number of an RxSight employee. The unauthorized actor obtained unauthorized access to the employee’s cloud-based work account,account and to e-mails and files that were accessible from that account. We discovered the incident on the same day and were able to prevent interruption of our information systems, and they remained operational during this unauthorized access. This incident did not have a material impact on our operations, financial systems, or financial condition. However, there can be no assurance that a similar incident would not have a future material impact on our operations, financial systems, or financial condition and we remain subject to various risks due to the incident.
Despite the implementation of security measures in our efforts to protect systems that store our information, given their size and complexity and the increasing amounts of information maintained on our internal information technology systems and external processing and storage systems (e.g., hosting), contractors and consultants and other third-party service providers, these systems are potentially vulnerable to breakdown or other damage or interruption. Our systems and the systems of third parties who support our operations are vulnerable to service interruptions, system malfunction, natural disasters, terrorism, war (such as the ongoing conflicts in the Middle East and between Ukraine and Russia) and telecommunication and electrical failures, as well as security breaches and incidents arising from or caused by inadvertent or intentional actions by our employees, contractors, consultants, business partners, and/or other third parties, or from cyber-attacks by malicious third parties (including the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability of information), which may compromise our system infrastructure or lead to unauthorized access to or disruption of our or third-party systems used in our business and the unauthorized access to, misuse, disclosure, loss, destruction, alteration or dissemination of, or damage to, our data, including trade secrets or other confidential information, intellectual property, proprietary business information, and personal information. For example, companies have experienced an increase in phishing and social engineering attacks from third parties in recent years. Our employees generally work in a hybrid model in our offices and from home, and we may need to adjust our working model from time to time. As a result, we have increased cyber-securitycybersecurity and data security risks, due to increased use of home wi-fi networks and virtual private networks, as well as increased disbursement of physical machines.
Furthermore,Furthermore the overall amount of reimbursement available for products and procedures intended to treat cataract and refractive conditions of the eye could remain at current levels or decrease in the future. Failure by doctors to obtain and maintain coverage and adequate reimbursement as well as patient charges for the procedures performed using our products would materially adversely affect our business, financial condition and results of operations.
In addition, there can be no guarantee that we will receive approval to sell our products in the international markets we target, nor can there be any guarantee that any sales would result even if such approval is received. Even if the FDA grants marketing approval for a product, comparable regulatory authorities of foreign countries must also approve the manufacturing or marketing of the product in those countries. Approval in the U.S.,U.S.,U.S., or in any other jurisdiction, does not ensure approval in other jurisdictions. Obtaining foreign approvals could result in significant delays, difficulties and costs for us and require additional clinical trials and additional expenses. Regulatory requirements can vary widely from country to country and could delay the introduction of our products in those countries. Clinical trials conducted in one country may not be accepted by other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. If we fail to comply with these regulatory requirements or to obtain and maintain required approvals, our target market will be reduced and our ability to generate revenue will be diminished. Our inability to successfully enter all our desired international markets and manage business on a global scale could negatively affect our business, financial results and results of operations.
Our success depends in large part on our ability to obtain, maintain, protect and enforce patent and other intellectual property protection in the U.S.U. S. and other countries with respect to our products and technology we develop. If we fail to obtain, maintain, protect and enforce our intellectual property, third parties may be able to compete more effectively against us, we may lose our technological or competitive advantage, or we may incur substantial litigation costs in our attempts to recover or restrict use of our intellectual property.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability and our owned and in-licensed issued patents may be challenged in courts or patent offices in the U.S. and abroad. For example, we may be subject to a third-party submission of prior art to the U.S. Patent and Trademark Office (“USPTO,USPTO”), challenging the validity of one or more claims of our owned or in-licensed issued patents. Such submissions may also be made prior to a patent’s issuance, precluding the granting of a patent based on one of our owned or in-licensed pending patent applications.
Furthermore, our owned and in-licensed patents may be subject to a reservation of rights by one or more third parties. For example, this could arise if the research resulting in certain of our owned or in-licensed patent rights and technology was funded in part by the U.S. government. As a result, the government may have certain rights, or march-in rights, to such patent rights and technology. When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a non-exclusive license authorizing the government to use the invention for non-commercial purposes. These rights may permit the government to disclose our confidential information to third parties and to exercise march-in rights to use or allow third parties to use our licensed technology. The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to U.S. industry. In addition, our rights in such inventions may be subject to certain requirements to manufacture products embodying such inventions in the U.S. The U.S. government has released a draft framework and recently taken actions to indicate closer review of patents resulting from government funding for compliance with the Bayh-Dole Act, which if found noncompliant, may be used by an agency to authorize the government to exercise its march-in rights for public comments, and as such, the framework for deciding when march-in rights are exercised may change. Any exercise by the government of such rights could harm our competitive position, business, financial condition, results of operations and prospects.
Because we rely on third parties to supply components, raw materials, chemicals and other supplies to manufacture our RxSight system, and any future products, and we expect to collaborate with third parties on the continuing development of our RxSight system, and any future products, we must, at times, share trade secrets with them. We also expect to conduct R&D programs that may require us to share trade secrets under the terms of our partnerships or agreements with contract research organizations (“CROCROs”)s.. We seek to protect our proprietary technology in part by entering into agreements containing confidentiality and use restrictions and obligations with our advisors, employees, contractors, contract manufacturing organizations (“CMOCMOs”)s,, CROs, other service providers and consultants prior to disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose our confidential information, including our trade secrets. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, in part, on our know-how and trade secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure would impair our competitive position and may have an adverse effect on our business and results of operations.
Even if we believe a third party’s intellectual property claims are without merit, there is no assurance that a court would find in our favor, including on questions of infringement, validity, enforceability or priority of patents. The strength of our defenses will depend on the patents asserted, the interpretation of these patents, and our ability to invalidate the asserted patents. A court of could hold that these third-party patents are valid, enforceable and infringed, which could materially and adversely affect our ability to commercialize any products or technology we may develop, and any other products or technologies covered by the asserted third-party patents. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court would invalidate the claims of any such U.S. patent. Conversely, the patent owner need only prove infringement by a preponderance of the evidence, which is a lower burden of proof.
InWe have entered into, and in the future, we may enter into additional agreements involving licenses or collaborations that provide for access or sharing of intellectual property. If we fail to comply with our obligations under any license, collaboration or other agreements, we may be required to pay damages and could lose intellectual property rights that are necessary for developing and protecting our current and future products.
We currently,currently (such as the RxSight-Alcon Collaboration Agreement), and in the future may continue to, license from third parties certain intellectual property relating to our current and future products. In the event we do so, we may have certain obligations to such licensors. If we breach any material obligations, or use the intellectual property licensed to us in an unauthorized manner, we may be required to pay damages and the licensor may have the right to terminate the license, which could result in us being unable to develop, manufacture, and sell products that are covered by the licensed technology or enable a competitor to gain access to the licensed technology.
Further, under the current leadership at the HHS, agency reorganization, departure of high-profile regulators at the FDA, and reduction in force (RIF) initiative, or layoffs, may impact the normal operations at the FDA as well as other federal agencies. FDA may lack adequate staff and resources to meet current review, approval, and inspection schedules, which could delay our anticipated timelines. In January 2025, President Trump issued an executive order entitled “Unleashing Prosperity Through Deregulation”, which calls for at least 10 existing regulations to be repealed whenever an executive department or agency publicly proposes for notice and comment or otherwise promulgates a new regulation. It is unclear how our industry and our clinical programs will be impacted by policies and regulations implemented under the current administrationadministration, or other executive orders. There is significant uncertainty in the industry and how federal agencies like the FDA will change in the coming years under the current administration. To the extent the agency reorganization and other agency changes lead to disruptions in FDA’s operations, including changes resulting from executive orders; freeze on hiring, federal funding for research, and external communications; layoffs; return-to-office policies, and changes in funding for certain programs at the FDA, correspondence and regulatory review processes with the FDA may be materially delayed.
In addition, we have conducted clinical trials in Mexico and may choose to conduct further international clinical trials. The acceptance of study data by the FDA or other comparable foreign regulatory authority from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (1) the data are applicable to the U.S.
In addition, we have conducted clinical trials in Mexico and may choose to conduct further international clinical trials. The acceptance of study data by the FDA or other comparable foreign regulatory authority from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the U.S., the FDA will generally not approve the application on the basis of foreign data alone unless (1) the data are applicable to the U.S. population and U.S. medical practice; (2) the clinical trials are performed by clinical investigators of recognized competence and pursuant to current good clinical practices regulations; and (3) audits by regulatory authorities of the clinical data do not identify significant data integrity issues. Additionally, the FDA’s clinical trial requirements, including the adequacy of the patient population studied and statistical powering, must be met. In addition, such foreign clinical trials are subject to the applicable local laws of the foreign jurisdictions where the clinical trials are conducted. There can be no assurance that the FDA or any applicable foreign regulatory authority will accept data from clinical trials conducted outside of its applicable jurisdiction. If the FDA or any applicable foreign regulatory authority does not accept such data, it would result in the need for additional clinical trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in our products not receiving approval or clearance for commercialization in the applicable jurisdiction.
If we do not remain in material compliance with the QMSRQMSR, or if the FDA, CDPH, or any applicable notified body in the European Union or United Kingdom inspects any of our facilities and discover compliance problems, we may have to cease manufacturing and product distribution until we can take the appropriate remedial steps to correct the audit findings. Taking corrective action may be expensive, time consuming and a distraction for management and if we experience a delay at our manufacturing facility, we may be unable to produce our products, which would harm our business.
In addition, other legislative changes have been proposed and adopted since the ACA was enacted. On August 2, 2011, the Budget Control Act of 2011 was signed into law, which, among other things, includes reductions to Medicare payments to providers of, on average, 2% per fiscal year, which went into effect on April 1, 2013, which, due to subsequent legislative amendments, will stay in effect through 2032, with the exception of a temporary suspension implemented under various COVID-19 relief legislation. In January 2013, President Obama signed into law the American Taxpayer Relief Act of 2012, which, among other things, reduced Medicare payments to several providers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our products, if approved, and accordingly, our financial operations. There is no assurance that the ACA, as currently enacted or as amended in the future, will not harm our business and financial results, and we cannot predict how future federal or state legislative or administrative changes relating to healthcare reform will affect our business.
The trading price of our common stock has been and may continue to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which we cannot control. From the date of our initial public offering through MayAugust 1, 2026, our common stock has traded at a low of $5.90$4.48 and a high of $66.54 on the Nasdaq Global Market. The stock market in general can experience extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these certain companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance. In addition to the factors discussed in “Part II, Item 1A, “Risk Factors,” and elsewhere in this report, these factors include:
The realization of any of the above risks or any of a broad range of other risks, including those described in this Part II, Item1A,Item 1A, “Risk Factors,” could have a dramatic and adverse impact on the market price of our common stock.
As of MarchJune 31,30, 2026, we had 41,384,12041,585,381 shares of common stock issued and outstanding. All of these shares are available for sale in the public market, subject to limitations under Rule 144 with respect to affiliates of our company.
In addition, Section 203 of the General Corporation Law of the State of DelawareDelaware, (“DGCL”), prohibits a publicly-held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person which together with its affiliates owns, or within the last three years has owned, 15% of our voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner.
Management's Discussion & Analysis (MD&A)
New heading “Recent developments”
New heading “Collaboration Revenue”
New heading “Product cost of sales”
New heading “Comparison of the six months ended June 30, 2026 and 2025”
New heading “Research and development expenses”
New heading “Other income (expense), net”
Removed heading “Comprehensive loss”
Largest changes
“Total revenue for the six months ended June 30, 2026, was $64.6 million, a decrease of $6.9 million, or 9.6%, compared to $71.5 million for the six months ended June 30, 2025. The decrease was primarily driven by reduced product sales of $13.4 million, or 18.7%, to $58.1 million for the six months ended June 30, 2026, from $71.5 million for the six months ended June 30, 2025. …”see in full comparison
“Total revenue for the three months ended June 30, 2026, was $33.7 million, an increase of $0.1 million, or 0.3%, compared to $33.6 million for the three months ended June 30, 2025. Product sales decreased by $6.4 million, or 19.0%, to $27.2 million for the three months ended June 30, 2026, from $33.6 million for the three months ended June 30, 2025. The decrease in product sales was primarily due to lower unit sales of both LDDs and LALs, reflecting, among other things, increased competition in the IOL market, including recent widespread competitive trialing activity for new product launches. …”see in full comparison
Uncertain macroeconomic conditions including recent inflationary pressures andsee in full comparisonthe rise in interest ratestariffs have created significant uncertainty in the U.S. economy and capital markets, whichis expected tomay continue through the remainder of 2026 and beyond and could negatively impact our financial results and liquidity.
Full comparison: every changed paragraph (74)
We are a commercial-stage medical technology company dedicated to providing high-qualityhigh quality customized vision to patients following cataract surgery. Our proprietary RxSight® Light Adjustable Lens system (“RxSight system”) is the first and only commercially available premium cataract technology that enables doctors to customize and optimize visual acuity for patients after surgery. The RxSight system is comprised of our RxSight Light Adjustable Lens® (“LAL®/” and “LAL+®”, collectively the “LAL”), RxSight Light Delivery Device™ (“LDD™”), and related accessories. The LAL is a premium intraocular lens (“IOL”) made from the proprietary silicone-based photosensitive material that undergoes controlled changes in refractive power when exposed to specific ultraviolet (“UV”) light patterns generated by the LDD.
In contrast, with the RxSight system, the surgeon implants the LAL as they would in any other cataract procedure, determines refractive error with patient input several weeks following surgery and then uses the LDD to modify the LAL with the precise visual correction needed to achieve the patient’s desired vision outcomes. We believe our RxSight system provides doctors and patients with increased confidence and peace of mind by eliminating the high-stakes preoperative guesswork common to conventional premium IOLs and allowing patients to iterate their final vision characteristics with customized post-surgical adjustments.
In contrast, with the RxSight system, the surgeon implants the LAL as they would in any other cataract procedure, determines refractive error with patient input several weeks following surgery and then uses the LDD to modify the LAL with the precise visual correction needed to achieve the patient’s desired vision outcomes. We believe our RxSight system provides doctors and patients with increased confidence and peace of mind by eliminating the high-stakes preoperative guesswork common to conventional premium IOLs and allowing patients to iterate their final vision characteristics with customized post-surgical adjustments. Currently, we primarily compete in the IOL market in the U.S. The LAL is a premium IOL which is partially reimbursable under Medicare, and in some cases by private payors. Premium IOLs are sold at a higher price point than conventional IOLs as they provide refractive vision correction, whereas conventional IOLs simply replace the natural lens with a clear lens (which is the standard for Medicare reimbursement). Our RxSight system is approved in the U.S. and in several foreign countries for improving uncorrected visual acuity by adjusting the LAL power to correct residual postoperative refractive error. We intend to seek additional approvals in the future to broaden our international presence. While we are growing our presence outside the U.S., we do not anticipate meaningful near-term sales from these non-U.S. regions.regions to be material to our consolidated results of operations in the foreseeable future.
We are a Delaware corporation headquartered in Aliso Viejo, California with two wholly owned subsidiaries located in Hong Kong (“RxSight, Hong Kong”) and in Amsterdam, Netherlands (“RxSight, Netherlands”). RxSight, Netherlands has a registered branch in the United Kingdom and a wholly owned subsidiary located in Germany (“RxSightRxSight, Germany”).
Our commercial efforts began in 2019, and have been primarily focused in the U.S., where we are building a “razor and razor blade” business model to drive new customer adoption and ongoing LAL volume growth. Our sales efforts are concentrated on the approximately 4,000 U.S. cataract surgeons that perform approximately 60% of all premium IOL procedures. As of MarchJune 31,30, 2026, we have established ana global installed base of 1,1541,166 LDDs in ophthalmology practices and, since our inception through MarchJune 31,30, 2026, surgeons have implanted approximately 332,000357,000 LALs.
We believe this business model provides an attractive and concentrated market opportunity addressable with a focused sales force. We intend to continue to make significant investments in our sales and marketingcommercial organization. We believe selectively increasing the number of sales representatives, practice development personnel and clinical trainers will help facilitate further adoption of our products among existing customer accounts as well as broaden awareness of our products to new accounts. We plan to grow our business primarily by expanding the size of our LDD installed base and driving increased utilization of our LAL through heightened awareness of the superior clinical outcomes that our RxSight system provides patients. To continue strengthening our competitive position in the premium IOL market, our research and development activities are focused primarily on programs that improve clinical outcomes, improve customer experience, expand our indications for use, reduce manufacturing costs and support lifecycle management.
Our near-term research and development activities are focused on enhancements to the RxSight system to improve clinical outcomes, enhance customer experience, expand our indications for use, reduce manufacturing costs and support lifecycle management. We believe our adjustable lens solution can be used to address a broad range of cataract surgery patients, including those that would otherwise elect for a conventional cataract procedure today. We will undertake additional clinical studies to expand the existing body of evidence related to the safety and effectiveness of our current and future generations of products. Finally, we may in the future seek to acquire or invest in additional businesses, products or technologies that we believe could complement or expand our portfolio, enhance our technical capabilities or otherwise offer growth opportunities. While we continue to make investments in our sales and marketing organization, including personnel in clinical applications, practice development, sales and technical service personnel, we also intend to expand our marketing efforts through additional print and digital, social media, education and other customer tools to drive further adoption of the RxSight system.
While we continue to make investments in our sales and marketing organization, including personnel in clinical applications, practice development, sales and technical service personnel, we also intend to expand our marketing efforts through additional print and digital, social media, education and other customer tools to drive further adoption of the RxSight system.
Recent developments
Leadership Transition and Board Appointment. On July 13, 2026, our Board appointed Aziz Mottiwala as President and Chief Executive Officer, effective as of his start date of July 20, 2026, succeeding Ron Kurtz, M.D., who had served in these roles since 2016. Effective upon Mr. Mottiwala's appointment, Dr. Kurtz transitioned to the role of Chief Medical Officer and resigned from the Board. In addition, effective July 20, 2026, Mr. Mottiwala was appointed to the Board as a Class II director and his term of office will expire at our 2029 annual meeting of stockholders or until his successor is duly elected and qualified.
Adoption of the RxSight, Inc. 2026 Inducement Equity Incentive Plan. On July 13, 2026, the Board adopted the RxSight, Inc. 2026 Inducement Equity Incentive Plan (the “Inducement Plan”), pursuant to which we may from time to time make equity grants to new employees as a material inducement to their employment. The Board reserved 3,500,000 shares of our common stock for issuance under the Inducement Plan. The Inducement Plan was adopted without stockholder approval pursuant to Nasdaq Listing Rule 5635(c)(4) and will be administered by the Compensation Committee of the Board.
Updated Product Pipeline. On July 6, 2026, we announced certain product pipeline updates, including the following:
o
Next-generation LAL, designed to deliver best-in-class visual quality and optical clarity, with post-operative refractive optimization to consistently achieve targeted visual outcomes;
o
Next-generation LAL+, designed to improve intermediate vision for everyday activities while preserving high-quality optical performance, with adjustability enabling precise refractive targeting; and o LAL Toric, designed with built-in astigmatism correction, while still enabling post-operative refinement of residual sphere and cylinder to maximize uncorrected visual acuity.
RxSight-Alcon Collaboration Agreement. On June 30, 2026, we entered into a License, Collaboration and Development Agreement (the “RxSight-Alcon Collaboration Agreement”) with Alcon Pharmaceuticals, Ltd (“Alcon”), pursuant to which we will collaborate with Alcon to develop and commercialize light-adjustable versions of certain Alcon simultaneous vision intraocular lenses (“SVIOLs”) by incorporating RxSight Light Adjustable Technology™. For more information regarding the RxSight-Alcon Collaboration Agreement, see (i) Note 1 to our unaudited condensed consolidated financial statements and the related notes to those statements included elsewhere in this report and (ii) Item 1.01 of our Current Report on Form 8-K filed with the SEC on July 6, 2026, which is incorporated herein by reference.
Our results are influenced by several key factors, including: (i) growth in our LDD installed base, which enables LALs to be implantedbase; (ii) the utilization of that installed base for LAL procedures, measured by the number of LALs implanted per installed LDD; (iii) product mix between LALs and LDDs, which affects our overall gross margins; (iv) manufacturing cost trends; and (v) seasonal and external factors that may affect cataract surgery volumes.volumes, including, among other things, competition (including the effect of recent competitive trialing activity associated with new product launches), physician reimbursement trends, and consumer sentiment which affects procedure timing. We believe the number of LDDs installed and LALs implanted are the strongest indicators of the adoption of our technology and our ability to generate revenue. We monitor average monthly utilization, which we define as the number of LALs implanted during a quarter divided by the LDD installed base at the end of the prior quarter. This fluctuates due to seasonality, practice ramp, and external disruptions (including severe weather events).
(1) Installed base at end of period includes LDDs placed with customers under rental arrangements.
During the quarter ended June 30, 2026, we sold 11 LDDs and placed 1 LDD on rental, a decrease of 28 units from 40 LDDs sold during the quarter ended June 30, 2025, due to slower LDD placements. LAL sales decreased by 2,463 when compared to the quarter ended June 30, 2025, primarily driven by fewer LALs being used in cataract surgeries.
During the quarter ended March 31, 2026, we sold 20 LDD units and 27,472 LALs.
Product Sales
Our sales consist of LALs used in cataract surgeries, the LDDs for delivering light to the LALs to adjust the lens post-surgery, as needed, and service and accessories. Revenue is derived from sales of products mainly in the U.S. and select international markets. Customers are primarily comprised of ophthalmic practices (LDD sales) and ambulatory surgery centers (LAL sales). We recently completed a full realignment of our U.S. commercial organization by integrating our clinical and sales teams into a single unified Customer Success Organization. Each integrated team within the Customer Success Organization is responsible for a defined group of doctors and practices, managing customer experience from onboarding through long-term LAL utilization growth. Following several years of rapid growth, sales moderated in 2025 and continued to decline through the firstsecond quarter of 2026, however, we expect our commercial realignment initiatives to position the company for renewed revenue growth. We plan to drive continued expansion by supporting existing practices and strategically expanding our LDD installed base and helping new adopters in achieving early success and sustained long-term growth.
Collaboration Revenue
We accounted for the RxSight-Alcon Collaboration Agreement under ASC Topic 606 and ASC Topic 808. We identified the following performance obligations under the agreement; (a) a license of our intellectual property; (b) Phase I Feasibility and Phase II Regulatory Activities required to achieve project milestones; and (c) material rights related to the commercial supply of Collaboration Products. We expect to satisfy the feasibility and regulatory performance obligations over an estimated development period of several years, and the material rights will be satisfied upon exercise or expiration.
At inception, the transaction price was $10.0 million, consisting of the non-refundable portion of the $60.0 million upfront payment. The remaining $50.0 million of the upfront payment is refundable if the agreement is terminated within the first 120 days of the effective date.
The transaction price excludes (i) potential milestone payments and (ii) sales-and usage-based royalties. The milestone payments represent variable consideration that is fully constrained under ASC 606-10-32-11 through 32-13, because achievement of the underlying feasibility and regulatory milestones is contingent on factors outside our control and it is not probable that a significant reversal of cumulative revenue would not occur. The royalties are excluded under the sales-and usage-based royalty exception in ASC 606-10-55-65 and will be recognized as the related sales or usage occur. We will reassess the estimate of constrained consideration at each reporting date, and amounts will be included in the transaction price when it becomes probable that a significant revenue reversal will not occur.
We have elected the optional exemptions in ASC 606-10-50-14 and 50-14A and therefore does not disclose the value of the remaining performance obligations for (i) variable consideration allocated to wholly unsatisfied performance obligations and (ii) consideration in the form of sales- and usage-based royalties.
We allocated the $10.0 million transaction price to the identified performance obligations based on their relative standalone selling prices. The standalone selling price of the license was estimated using a discounted cash flow analysis reflecting forecasted revenues, development timelines and expenses, discount rates, and probabilities of feasibility and regulatory success. The standalone selling price of the Feasibility and Regulatory Activities was estimated based on forecasted costs over the expected development period.
• Licensed Intellectual Property — For licensed intellectual property that is distinct from other performance obligations, We recognize the upfront license fee and any milestone payments allocated to the license when the license is transferred and the licensee is able to benefit from it. We determined that Alcon could benefit from the license at the time it was granted; accordingly, the related performance obligation was satisfied at a point in time.
• Project Activities — At inception of an arrangement that includes milestone-based payments, We evaluated whether each milestone is probable of being achieved and estimates the amount to include in the transaction price using the most-likely-amount method, subject to the constraint. Because achievement of the milestones is not within our control, we recognize the associated consideration when the milestone is probable of being achieved.
• Material Rights to Product Supply — When a contract grants the customer an option to acquire additional goods or services at a price other than their standalone selling price, We assesses whether the option represents a material right. Material rights are accounted for as separate performance obligations, with revenue recognized when the right is exercised or expires.
During the second quarter of 2026, we recorded a receivable for the full $60.0 million upfront payment (subsequently received on July 1, 2026). Of the $10.0 million initial transaction fee, $6.5 million was allocated to the license of intellectual property and recognized as revenue on the effective date of the agreement, and the remaining $3.5 million was allocated to the other performance obligations and recorded as deferred revenue in our condensed consolidated balance sheet as of June 30, 2026. The remaining $50.0 million is recorded as a refund liability and is not included in the transaction price.
For the three and six months ended MarchJune 31,30, 2026 and 2025, revenue from contracts with customers consisted of the following (in thousands):
Product cost of sales
For the three months ended March 31, 2026 and 2025 we did not have any one customer who individually accounted for more than 10% of revenue.
CostProduct cost of sales consist of materials, labor and manufacturing overhead internally to produce our products as well as the cost of shipping and handling. Overhead costs include the cost of quality assurance, material procurement, inventory control, facilities, equipment and operations management and stock-based compensation. CostProduct cost of sales also includes depreciation expense for production equipment and certain direct costs such as shipping costs. Shipping costs billed to customers are included in sales. As we grow our revenue, we expect product cost of sales to increase in absolute dollars reflecting the higher volume of products sold.
We calculate product gross margin as product gross profit divided by product sales. Product gross profit represents product revenue less product cost of sales. Our product gross margin has been and will continue to be affected by a variety of factors, including average selling prices, product sales mix, production and ordering volumes, manufacturing costs, product yields, headcount and cost-reduction strategies. Our product gross margin could fluctuate from quarter to quarter as we introduce new products, increase or decrease units of production for both the LDD and LAL and as we adopt new manufacturing processes and technologies.
Research and development expenses consist of expenses incurred in performing research and development and engineering activities for new products and technology, clinical studies and regulatory submissions and compliance. The expenses include personnel-related expenses, including wages, incentive bonuses, stock-based compensation and benefits, costs incurred at clinical trial sites, regulatory and manufacturing engineering costs, including those related to various laboratory and research equipment and supplies, expense of pre-approved inventory utilized for clinical trial and research purposes, costs incurred in the development of manufacturing processes in excess of capitalizable value, fees paid to consultants and contract clinical organizations and direct FDA related costs and costs related to FDA premarket approval submission preparation. Research and development expenses are expensed as incurred. We expect research and development expenses to increase substantially in future periods as we incur additional costs associated with the development of the Collaboration Products under the RxSight-Alcon Collaboration Agreement. We expect research and development expenses as a percentage of revenue to vary over time depending on the level and timing of our new product development efforts, as well as our clinical development, clinical trials and registries and other related activities.
Comprehensive loss
Comparison of the three months ended MarchJune 31,30, 2026 and 2025
The following table summarizes our results of operations for the three months ended MarchJune 31,30, 2026 and 2025 together with the dollar increase or decrease and percentage change in those items.
Revenue
Total revenue for the three months ended June 30, 2026, was $33.7 million, an increase of $0.1 million, or 0.3%, compared to $33.6 million for the three months ended June 30, 2025. Product sales decreased by $6.4 million, or 19.0%, to $27.2 million for the three months ended June 30, 2026, from $33.6 million for the three months ended June 30, 2025. The decrease in product sales was primarily due to lower unit sales of both LDDs and LALs, reflecting, among other things, increased competition in the IOL market, including recent widespread competitive trialing activity for new product launches. Collaboration revenue was $6.5 million for the three months ended June 30, 2026, which relates to the upfront licensing fee for our LAL intellectual property.
Cost of Sales
Sales decreased by $7.0 million, or 18.5%, to $30.9 million for the three months ended March 31, 2026, from $37.9 million for the three months ended March 31, 2025. The decrease in total sales was primarily due to lower LDD unit volumes.
Cost of sales decreased by $2.2$0.6 million, or 22.7%,7.0%, to $7.4$7.9 million for the three months ended MarchJune 31,30, 2026, from $9.6$8.4 million for the three months ended MarchJune 31,30, 2025, primarily due to the decreased number of LDDs and LALs sold during the period.period Grossas compared to the same period in the prior year. Product gross margin increaseddecreased to 76.1%71.2% in the three months ended MarchJune 31,30, 2026, from 74.8%74.9% for the three months ended MarchJune 31,30, 2025,2025. The decrease is primarily due to ahigher-cost favorableinventory productand mixhigher frominventory-related a greater percentage of revenue from LAL sales.costs.
SG&A expenses increased by $3.2$1.4 million, or 11.2%,5.0%, to $31.9$30.4 million for the three months ended MarchJune 31,30, 2026, from $28.6$29.0 million for the three months ended MarchJune 31,30, 2025. This increase was drivenprimarily attributable to higher professional services fees of approximately $3.3 million, partially offset by lower clinical and regulatory expenses of $1.2 million as a significant number of projects concluded in partlate 2025, and lower stock based compensation expense of approximately $1.0 million primarily driven by personnel-relatedthe expensesrecent as we continue to prioritize investments in new hires and ongoing expansiondepartures of ourcertain globalcompany commercial and support teams.executives.
Research and development expenses decreased by $0.9$1.0 million, or 8.6%,9.6%, to $9.5$9.2 million for the three months ended MarchJune 31,30, 2026, from $10.4$10.2 million for the three months ended MarchJune 31,30, 2025. This decrease was primarily attributable to $0.6 million from reducedlower compensation and benefitsother and facilityemployee-related costs dueof toapproximately $0.9 million primarily driven by reduced headcount whenas comparedwell as allocations of certain employees to manufacturing during the threesecond monthsquarter ended March 31,of 2025.
Other income (expense), net, decreased $0.6by $0.5 million to income of $2.0$1.8 million for the three months ended MarchJune 31,30, 2026, compared to income of $2.5$2.3 million for the three months ended MarchJune 31,30, 2025. The decrease was primarily due to decreased interest income from lower interest rates and lower cash and short-term investment balances.
Comparison of the six months ended June 30, 2026 and 2025
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025 together with the dollar increase or decrease and percentage change in those items:
Revenue
Total revenue for the six months ended June 30, 2026, was $64.6 million, a decrease of $6.9 million, or 9.6%, compared to $71.5 million for the six months ended June 30, 2025. The decrease was primarily driven by reduced product sales of $13.4 million, or 18.7%, to $58.1 million for the six months ended June 30, 2026, from $71.5 million for the six months ended June 30, 2025. The decrease in product sales was primarily due to lower unit sales of both LDDs and LALs, reflecting, among other things, increased competition in the IOL market, including recent widespread competitive trialing activity for new product launches. The overall decrease in total revenue was partially offset by contract revenues from the RxSight-Alcon Collaboration Agreement of $6.5 million, which relate to the upfront licensing fee for our LAL intellectual property.
Cost of sales decreased by $2.8 million, or 15.3%, to $15.3 million for the six months ended June 30, 2026 from $18.0 million for the six months ended June 30, 2025, primarily due to the decrease in the number of units sold during the period as compared to the same period in the prior year. Product gross margin decreased to 73.8% in the six months ended June 30, 2026, from 74.8% for the six months ended June 30, 2025, primarily due to higher-cost inventory and higher inventory-related costs.
SG&A expenses
SG&A expenses increased by $4.7 million, or 8.1%, to $62.3 million for the six months ended June 30, 2026, from $57.6 million for the six months ended June 30, 2025. This increase was primarily attributable to higher professional services fees of $6.7 million. Additional increases were due to higher compensation and other employee-related costs of $1.7 million and higher office and other expenses of $0.2 million. These increases were partially offset by lower clinical and regulatory expenses of $3.1 million as most projects concluded in late 2025 and lower marketing and customer acquisition expenses of $0.5 million.
Research and development expenses
Research and development expenses decreased by $1.9 million, or 9.1%, to $18.7 million for the six months ended June 30, 2026, from $20.6 million for the six months ended June 30, 2025. This decrease was primarily due to lower compensation and other employee-related costs of $3.2 million, primarily driven by reduced headcount and allocations of certain employees to manufacturing during the second quarter of 2025, which were partially offset by higher professional services fees of $0.3 million and higher research and development project expenses of $0.9 million.
Other income (expense), net
RXST insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 4 filings (4 insiders, 1 trade date, 16,947 shares, about $118.0K). Net open-market shares: -16,947 (purchases minus sales); net value about -$118.0K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-09-15 | Weinberg Eric |
Option exercise | 35,168 | $4.34 | $152.6K |
| 2026-09-02 | Kurtz Ronald M Md |
Open-market sale | 5,100 | $6.96 | $35.5K |
| 2026-09-02 | Wilterding Mark |
Open-market sale | 7,765 | $6.96 | $54.0K |
| 2026-09-02 | Goldshleger Ilya |
Open-market sale | 2,041 | $6.96 | $14.2K |
| 2026-09-02 | Weinberg Eric |
Open-market sale | 2,041 | $6.96 | $14.2K |
| 2026-08-31 | Kurtz Ronald M Md |
Option exercise | 13,425 | — | — |
| 2026-08-31 | Wilterding Mark |
Option exercise | 20,441 | — | — |
| 2026-08-31 | Goldshleger Ilya |
Option exercise | 5,370 | — | — |
| 2026-08-31 | Weinberg Eric |
Option exercise | 5,370 | — | — |
| 2026-06-17 | Warner Robert Keith |
Grant/award | 37,037 | — | — |
| 2026-06-17 | Palmisano Robert J |
Grant/award | 37,037 | — | — |
| 2026-06-17 | Maniar Shweta |
Grant/award | 37,037 | — | — |
| 2026-06-17 | Fountain Tamara |
Grant/award | 37,037 | — | — |
| 2026-06-17 | Link William J Phd |
Grant/award | 37,037 | — | — |
| 2026-06-17 | Corley Jesse Anderson |
Grant/award | 37,037 | — | — |
| 2026-06-17 | Cohen Raymond W |
Grant/award | 30,864 | — | — |
| 2026-06-17 | Tammenoms Bakker Juliet |
Grant/award | 37,037 | — | — |
| 2026-06-17 | Andrews Julie |
Grant/award | 37,037 | — | — |
| 2026-04-17 | Goldshleger Ilya |
Option exercise | 12,489 | $4.13 | $51.6K |
Well-known investors holding RXST (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Millennium Management (Israel Englander) | 2026-06-30 | 3,030,287 | $14.6M | 0.01% | Added 47% |
| D. E. Shaw & Co. | 2026-06-30 | 1,985,215 | $9.6M | 0.01% | Added 1% |
| AQR Capital Management (Cliff Asness) | 2026-06-30 | 1,533,826 | $7.4M | 0.0% | Added 141% |
| Two Sigma Investments | 2026-06-30 | 1,147,048 | $5.5M | 0.0% | Reduced 12% |
| Baillie Gifford | 2026-06-30 | 690,279 | $4.3M | — | Sold out |
| Point72 Asset Management (Steve Cohen) | 2026-06-30 | 778,252 | $3.8M | 0.01% | Added 6% |
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 700,736 | $3.4M | 0.0% | Reduced 37% |
| Renaissance Technologies | 2026-06-30 | 140,693 | $678.1K | 0.0% | Added 133% |