ESCALON MEDICAL CORP

Escalon Medical Corp. operates in the healthcare market, specializing in the development, manufacture, marketing and distribution of medical devices for ophthalmic applications, and its products are subject to regulation and inspection by the United States Food and Drug Administration. The ophthalmic market in general is intensely competitive, with each company eager to expand its market share, and several large companies dominate the ophthalmic market, with the balance of the industry being highly fragmented and comprised of smaller companies ranging from start-up entities to established market players. Competitors include ophthalmic-oriented companies that market a broad portfolio of products, including companies that market prescription devices and pharmaceuticals exclusively for ophthalmic indications and integrated companies that market products for ophthalmic and other indications. The medical device and pharmaceutical markets in which the Company competes are characterized by rapidly changing technology, short product life cycles, cyclical oversupply and rapid price erosion, and many of the Company's competitors have substantially greater financial, technical, marketing, distribution and other resources. The development of optical technologies for ophthalmic biometrics and imaging may also diminish the Company's market position, as this equipment can be used instead of ultrasound equipment in certain applications with some advantage, though such equipment is more expensive.

Sonomed has had a leading presence in the ophthalmic ultrasound industry for over 30 years ¹, which management believes has helped Sonomed build a reputation as a long-standing operation that provides a quality product, enabling the Company to establish effective distribution coverage throughout the world. The Company's strategy is to compete primarily on the basis of technological innovation to which it has proprietary rights, and it believes its business will depend in large part on protecting its intellectual property through maintaining trade secrets, patents, and other governmental regulations. The Company believes it establishes competitive advantage by offering technical innovation, product features, low total cost of ownership, and capable and responsive technical support, and to remain competitive it needs to maintain a low-cost operation. Various competitors offering similar products at a lower price could threaten Sonomed's market position. The Company currently holds two United States patents covering certain of its technologies ², although it does not believe its current products, revenues or competitive position are materially dependent on patent protection.

The Company operates its business as one operating and reportable segment ³, generating revenue through the sale of ophthalmic medical devices and related products and through service plans. Net revenues are divided between products, which totaled $12,082,609 ⁴ in the year ended June 30, 2026, and service plans, which totaled $653,536 ⁵, for total revenues, net of $12,736,145 ⁶. The Company's products are sold through independent sales representatives, a network of distributors, and internal sales employees directly to medical institutions, throughout the world, with domestic sales of $6,830,000 ⁷ representing 53.6% ⁸ of total revenue and foreign sales of $5,906,000 ⁹ representing 46.4% ¹⁰. The Company maintains a full-service program for all products sold, provides limited warranties on all products against defects and performance, and makes product repairs at its New York facility for ultrasound products, while service support for AXIS Imaging Management and surgical products are provided remotely.

The Company's product portfolio centers on ophthalmic ultrasound and surgical products. The A-Scan provides information about the internal structure of the eye by sending a beam of ultrasound along a fixed axis through the eye and displaying the various echoes reflected from the surfaces intersected by the beam, with information primarily used to calculate lens power for implants. The B-Scan is primarily a diagnostic tool that supplies information to physicians where the media within the eye are cloudy or opaque, and its transducer swings through a 60 degree sector to provide a two-dimensional image of the eye. The UBM is a high frequency/high resolution ultrasound device designed to provide highly detailed information about the anterior segment of the eye, used for glaucoma evaluation, tumor evaluation and differentiation, pre- and post-intraocular lens implantation and corneal refractive surgery. Pachymeters use the same principles as the A-Scan but are tailored to measure the thickness of the cornea, with central corneal thickness used in the calculation of intraocular pressure and pachymetry also used by refractive surgeons to screen candidates and help plan surgery.

The Company distributes two intraocular gas products, C3F8 and SF6, used by vitreoretinal surgeons as a temporary tamponade in detached retina surgery, under a non-exclusive distribution agreement with AirGas, Inc., distributing packages of AirGas gases in canisters containing up to 25 grams of gas ¹¹, and along with the intraocular gases the Company manufactures and distributes a patented disposable universal gas kit that delivers the gas from the canister to the patient. The Company markets disposable surgical packs used in vitreoretinal surgery, including packs which aid surgeons in the process of injecting and extracting silicone oil. The AXIS Image Management system easily manages ophthalmic diagnostic images via a web browser from any device regardless of modality, device manufacturer or location. During the year ended June 30, 2026, the Company sold its AXIS software for an aggregate purchase price of $3,000,000 ¹², receiving net proceeds of $2,800,000 ¹³ and recognizing a gain of $2,813,525 ¹⁴, before income taxes, on the sale.

The Company assembles and distributes its ophthalmic surgical products at its 7,440 square foot leased facility in New Berlin, Wisconsin ¹⁵, and designs, assembles, and services its ophthalmic ultrasound products at its 5,811 square foot leased facility in Westbury, New York ¹⁶, having done so in a 6728 square foot leased facility in Lake Success, New York ¹⁷ prior to its relocation during the year ended June 30, 2026. The Company has registered its facilities with the FDA and has attained ISO 13485 certification for its facilities and medical devices, and has obtained European Community certification (CE-Mark) for many of its medical devices. As of June 30, 2026, the Company employed 40 employees ¹⁸, of which 19 ¹⁹ are employed in manufacturing, 15 ²⁰ in general and administrative positions, and 6 ²¹ in sales and marketing, and the Company's employees are not covered by a collective bargaining agreement. Company-sponsored research and development expenditures from operations for the fiscal years ended June 30, 2026 and 2025 were approximately $501,000 ²² and $753,000 ²³, respectively.

Consolidated net revenue increased approximately $690,000 ²⁴, or 5.7% ²⁵, to $12,736,000 ²⁶ during the year ended June 30, 2026, as compared to the prior fiscal year, with the increase mainly attributable to a $1,259,000 ²⁷ increase in sales of Sonomed products and services, partially offset by a $518,000 ²⁸ decrease in sales of Trek products and a $51,000 ²⁹ decrease in AXIS revenue. Consolidated cost of revenue totaled approximately $7,167,000 ³⁰, or 56.3% ³¹, of total revenue, as compared to $6,535,000 ³², or 54.3% ³³, of total revenue of the prior fiscal year, with the 2.0% ³⁴ increase in cost of revenue as a percentage of total revenue mainly due to change in product mix. Consolidated marketing, general and administrative expenses increased $398,000 ³⁵, or 8.6% ³⁶, to $5,023,000 ³⁷, while consolidated research and development expenses decreased $252,000 ³⁸, or 33.5% ³⁹, to $501,000 ⁴⁰. Income from operations was $45,235 ⁴¹ for the year ended June 30, 2026, compared to $133,217 ⁴² for the prior fiscal year, and net income was $4,012,626 ⁴³ compared to $105,525 ⁴⁴, with net income applicable to common stockholders of $2,012,326 ⁴⁵ and basic and diluted income per share of $0.27 ⁴⁶.

The Company's growth strategy centers on the introduction of new or enhanced products, with research and development expenses primarily associated with the introduction of new or enhanced products. During the year ended June 30, 2026, the Company invested a $152,000 ⁴⁷ increase in ultrasound development, offset by a $406,000 ⁴⁸ decrease in nonrecurring AXIS consulting expenses, reflecting a strategic pivot toward its core ophthalmic ultrasound business following the sale of the AXIS software business. The Company's strategy is to compete primarily on the basis of technological innovation to which it has proprietary rights, and the success of new product offerings will depend on the Company's ability to properly identify customer needs, innovate and develop new technologies, services and applications, establish adequate product distribution coverage, obtain and maintain required regulatory approvals from the FDA and other regulatory agencies, protect its intellectual property, successfully commercialize new technologies in a timely manner, manufacture and deliver products in sufficient volumes on time, differentiate its offerings from competitors, price products competitively, and anticipate competitors' announcements of new products, services or technological innovations.

The Company's international presence represents a significant growth vector, with foreign sales of $5,906,000 representing 46.4% of total revenue in the year ended June 30, 2026, up from $5,305,000 ⁴⁹ or 44.0% ⁵⁰ in the prior fiscal year. The Company has obtained European Community certification (CE-Mark) for many of its medical devices, which allows it to sell products in the countries comprising the European Community, and in addition to the CE Mark, some foreign countries require separate individual foreign regulatory clearances. The Company's products are sold through independent sales representatives, a network of distributors, and internal sales employees directly to medical institutions throughout the world, and Sonomed's leading presence in the ophthalmic ultrasound industry for over 30 years has enabled the Company to establish effective distribution coverage throughout the world. The Company may be required to obtain FDA clearance or approval before exporting a product or device that has not received FDA marketing clearance or approval.

The Company's cost structure evolution reflects a focus on maintaining a low-cost operation, which it believes is necessary to remain competitive. Consolidated cost of revenue totaled approximately $7,167,000 , or 56.3% , of total revenue during the year ended June 30, 2026, as compared to $6,535,000 , or 54.3% , of total revenue of the prior fiscal year, with the 2.0% increase in cost of revenue as a percentage of total revenue mainly due to change in product mix. Consolidated marketing, general and administrative expenses increased $398,000 , or 8.6% , to $5,023,000 , mainly due to increases in compensation, including bonuses and fringe benefits, legal expenses, advertising expenses, and travel expenses, partially offset by decreases in network expenses and a favorable bad debt adjustment. Consolidated research and development expenses decreased $252,000 , or 33.5% , to $501,000 , mainly due to a $406,000 decrease in nonrecurring AXIS consulting expenses offset by a $152,000 increase in ultrasound consulting expenses.

The Company's operational outlook is shaped by its manufacturing footprint and supply chain posture. The Company assembles and distributes its ophthalmic surgical products at its 7,440 square foot leased facility in New Berlin, Wisconsin , and designs, assembles, and services its ophthalmic ultrasound products at its 5,811 square foot leased facility in Westbury, New York . In addition to performing its own assembly, the Company subcontracts component manufacturing, sterilization, and other services to various qualified vendors, and although some of the parts and components used to manufacture the Company's products are available from multiple sources, the Company currently purchases most of its components and outsourced finished goods from single sources in an effort to obtain volume discounts. The Company has registered its facilities with the FDA and has attained ISO 13485 certification for its facilities and medical devices, and has obtained European Community certification (CE-Mark) for many of its medical devices. As of June 30, 2026, the Company employed 40 employees , of which 19 are employed in manufacturing, 15 in general and administrative positions, and 6 in sales and marketing.

The Company's capital allocation priorities emphasize liquidity preservation and funding of operations from cash on hand, cash generated from operations, investment income, and revenues from the licensing and sale of its products. Company-sponsored research and development expenditures from operations for the fiscal years ended June 30, 2026 and 2025 were approximately $501,000 and $753,000 , respectively. Cash flows provided by investing activities for the year ended June 30, 2026 was due to net proceeds from sales of AXIS software of $2,800,000 , offset by purchase of the fixed assets of $4,000 ⁵¹, and any necessary capital expenditures have generally been funded out of cash from operations, with the Company not aware of any factors that would cause historical capital expenditure levels to not be indicative of capital expenditures in the future. The Company has never declared or paid a cash dividend on its common stock and presently intends to retain any future earnings to finance future growth and working capital needs, and does not anticipate paying cash dividends in the foreseeable future.

The Company faces structural headwinds from recently announced tariffs and trade measures. Beginning in the third quarter of fiscal year 2025, the U.S. government announced new tariffs on a broad range of imports, including a 10% tariff on most imports ⁵² and additional individualized higher tariffs on certain specific goods and countries, and in response, certain affected countries have imposed or may impose retaliatory tariffs on U.S. exports. Increased costs of imported raw materials, components, and finished goods may negatively impact profitability and gross margins, and the Company may face challenges in passing these increased costs on to its customers due to competitive pressures or market conditions. The uncertainty surrounding the duration and extent of these tariffs, as well as potential trade policy changes, could disrupt the Company's supply chain, require alternative and potentially more expensive sourcing options, and impact long-term strategic planning and investment decisions, and the ultimate financial impact of these tariffs and the associated uncertainty cannot be reasonably estimated at this time.

The Company faces execution risks related to its material weakness in internal control over financial reporting, which was first identified as of June 30, 2023 ⁵³ and has not yet been remediated. The material weakness relates to the design and implementation of controls over estimates used in the valuation of inventory, specifically the precision of management's review of inventory reserve calculations. Beginning in the fourth quarter of fiscal 2024 and continuing through fiscal 2025 and 2026, management implemented additional controls, including a standardized process for updating standard costs, enhanced segregation of duties over updates and reviews, improved data accuracy and integrity in the valuation calculations, and senior management review of all material estimates. However, the inventory reserve spreadsheet continues to rely on various manual entries, and management's review covers preset links and formulas but does not extend to certain manual inputs and links, and testing of the operating effectiveness of the enhanced controls has not been completed. Accordingly, management concluded that the material weakness continued to exist as of June 30, 2026 ⁵⁴ and that the Company's internal control over financial reporting was not effective as of that date.

The most material risks to Escalon Medical Corp. center on its competitive position, supply chain concentration, regulatory exposure, and internal control deficiencies. The ophthalmic market is intensely competitive, with several large companies dominating and many competitors possessing substantially greater financial, technical, marketing, and distribution resources, and various competitors offering similar products at a lower price could threaten Sonomed's market position. The Company purchases most of its components and outsourced finished goods from single sources in an effort to obtain volume discounts, and the lack of availability of any of these parts, components and finished goods could result in production delays, increased costs or costly redesign of the Company's products. The Company's products are subject to stringent ongoing regulation by the FDA and similar health care regulatory authorities, and any restrictions on or revocation of FDA approvals and clearances would prevent the continued marketing of impacted products and impair the Company's ability to generate funds from operations. The Company maintains limited product liability insurance coverage of $1,000,000 per occurrence ⁵⁵ and $2,000,000 in the aggregate ⁵⁶, with umbrella policy coverage of $5,000,000 in excess of such amounts ⁵⁷, and a successful product liability claim in excess of any insurance coverage may adversely impact the Company's financial condition and results of operations. The Company has identified a material weakness in its internal control over financial reporting that existed as of June 30, 2026 , relating to the design and implementation of controls over estimates used in the valuation of inventory, which was first identified as of June 30, 2023 and has not yet been remediated, and if the Company is unable to remediate the material weakness, its ability to report financial results on a timely and accurate basis could be adversely affected. The Company's Chairman and Chief Executive Officer, Richard DePiano Jr., is the Company's controlling stockholder, and the holders of Series A Convertible Preferred Stock currently beneficially own approximately 77.81% ⁵⁸ of the voting power on all actions to be taken by the Company's stockholders, which may have an adverse effect on the price of the Company's common stock because of the absence of any potential takeover premium.

Management's message to shareholders emphasizes a strategic pivot toward the core ophthalmic ultrasound business following the sale of the AXIS software business, which generated net cash proceeds of approximately $2.8 million and substantially improved the Company's liquidity. The Company reported income from continuing operations of approximately $45,000 for the fiscal year ended June 30, 2026, compared to net income from continuing operations of $133,000 for the year ended June 30, 2025, representing a significant improvement over the prior years when there were net losses from continuing operations. Management believes the Company has sufficient liquidity to fund its operations, working capital needs, and strategic initiatives for the foreseeable future based on its current cash position, anticipated operating cash requirements, and planned investment strategy, and will continue to monitor operating performance, cash flows, and capital requirements and may evaluate additional financing, strategic partnerships, or capital market opportunities if such transactions are deemed beneficial to the Company and its stockholders. The Company's strategic priorities center on competing primarily on the basis of technological innovation to which it has proprietary rights, maintaining a low-cost operation to remain competitive, and protecting its intellectual property through maintaining trade secrets, patents, and other governmental regulations. Management also emphasized the Company's ongoing remediation efforts related to the material weakness in internal control over financial reporting, having implemented additional controls including a standardized process for updating standard costs, enhanced segregation of duties over updates and reviews, improved data accuracy and integrity in the valuation calculations, and senior management review of all material estimates, though the material weakness continued to exist as of June 30, 2026 .