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i0000862668i6/30i10-Ki6/30/2022i2022iFYiTRUEiFALSEi000-20127iFALSEitrueifalsei7,415,329i0.001i0.001i35,000,000i35,000,000i7,415,329i7,415,329i7,415,329i7,415,329i0.001i0.001i2,000,000i2,000,000i2,000,000i2,000,000iP1YiP5YiP10YiP11YiP20YiRetirement
and Post-Retirement Plans
On June 23, 2005the Company entered into a Supplemental Executive Retirement Benefit Agreement with its former Chairman, Mr. DePiano Sr.. The agreement provided for the payment of supplemental retirement benefits to the covered executive in the event of the covered executive’s termination of services. In January 2013 the covered executive retired and the Company was obligated to pay the executive $8,491 per month for life, with payments commencing the month after retirement.
As of July 1, 2019 approximately $792,000 was accrued for Mr. DePiano, Sr.'s retirement benefits. The amount represented the approximate
present value of the supplemental retirement benefits awarded using a discount rate of 4.5% as of July 1, 2019. Mr. DePiano Sr. passed away on October 3, 2019. According to the agreement, the benefits terminate upon Mr. DePiano, Sr.'s death. Therefore, the Company recognized a gain with the termination of the retirement benefit obligation of $758,000, which has been reported as other income for the year ended June 30, 2020.
(Exact name of registrant as specified in its charter)
iPennsylvania
i33-0272839
(State
or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
i435 Devon Park Drive, Suite 824, iWayne,
iPAi19087
(Address of principal executive offices, including zip code)
(i610)
i688-6830
(Registrant’s telephone number, including area code)
Securities Registered Pursuant to Section 12(b) of the Act: NONE
Securities Registered Pursuant to Section 12(g) of the Act: NONE
Common
Stock, par value $0.001
Indicate by check mark if the registrant is a well-known seasoned issuer as defined in Rule 405 of the Securities Act. Yes oiNox
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes oiNox
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. iYesx No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). iYesx No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions
of "large accelerated filer,""accelerated filer,""smaller reporting company" and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer
o
Accelerated filer
o
iNon-accelerated
filer
x
Smaller reporting company
x
Emerging growth company
io
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. o
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes o No x
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant on December 31, 2021 was approximately $i327,167,
computed by reference to the price at which the common equity was last sold on the OTCQB Market on such date.
Certain statements contained in, or incorporated by reference in, this report are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which provide current expectations or forecasts of future events. Such statements can be identified by the use of terminology such as “anticipate,”“believe,”“could,”“estimate,”“expect,”“forecast,”“intend,”“may,”“plan,”“possible,”“project,”“should,”“will,”“would,”“seek,” and similar words or expressions. The Company’s forward-looking statements include certain
information relating to general business strategy, growth strategies, financial results, liquidity, product development, the introduction of new products, the enhancement of existing products, the potential markets and uses for the Company’s products, the Company’s regulatory filings with the FDA, acquisitions, the development of joint venture opportunities, intellectual property and patent protection and infringement, the loss of revenue due to the expiration on termination of certain agreements, the effect of competition on the structure of the markets in which the Company competes, increased legal, accounting and Sarbanes-Oxley compliance costs, the
Company's ability to continue as a going concern, defending the Company in litigation matters and the Company’s cost-saving initiatives. The reader must carefully consider forward-looking statements and understand that such statements involve a variety of risks and uncertainties, known and unknown, and may be affected by assumptions that fail to materialize as anticipated. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. It is not possible to foresee or identify all factors affecting the Company’s forward-looking statements, and the reader therefore should not consider the following list of risk factors to be an exhaustive statement of all risks, uncertainties
or potentially inaccurate assumptions. The Company cautions the reader to consider carefully these factors as well as the specific factors discussed with each specific forward-looking statement in this Form 10-K annual report and in the Company’s other filings with the Securities and Exchange Commission (the “SEC”). In some cases, these factors have impacted, and in the future (together with other unknown factors) could impact, the Company’s ability to implement the Company’s business strategy and may cause actual results to differ materially from those contemplated by such forward-looking statements. Any expectation, estimate
or projection contained in a forward-looking statement may not be achieved. The Company also cautions the reader that forward-looking statements speak only as of the date made. The Company undertakes no obligation to update any forward-looking statement, but investors are advised to consult any further disclosures by the Company on this subject in the Company’s filings with the SEC.
ITEM 1. BUSINESS
Company
Overview
Escalon Medical Corp. ("Escalon" or "Company") is a Pennsylvania corporation initially incorporated in California in 1987, and reincorporated in Pennsylvania in November 2001. Within this document, the “Company” collectively shall mean Escalon, which includes its division called "Trek" and its wholly owned subsidiaries: Sonomed, Inc. (“Sonomed”), Escalon Digital Solutions, Inc. (“EMI”), and Sonomed IP Holdings, Inc. All intercompany accounts and transactions have been eliminated. The Company dissolved two other inactive entities, Escalon Holding, Inc. ("EHI"), and Escalon IP Holdings Inc. in a tax-free dissolution under Section 332 of the Internal Revenue Code
in the year ended June 30, 2021.
The Company operates in the healthcare market, specializing in the development, manufacture, marketing and distribution of medical devices for ophthalmic applications. The Company and its products are subject to regulation and inspection by the United States Food and Drug Administration (the “FDA”). The FDA and other government authorities requires extensive testing of new products prior to sale and has jurisdiction over the safety, efficacy and manufacture of products, as well as product labeling and marketing.
A-Scans
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. The principal echoes occur at the cornea, both surfaces of the lens and the retina. The system displays the position and magnitudes of the echoes on an electronic display. The A-Scan also includes software for measuring distances within the eye. This information is primarily used to calculate lens power for implants.
B-Scans
The B-Scan is primarily a diagnostic tool that supplies information to physicians where the media within the eye are cloudy or opaque. Whereas physicians normally use light, which cannot pass through such media, the ultrasound beam is
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capable
of passing through the opacity and displaying an image of the internal structures of the eye. Unlike the A-Scan, the B-Scan transducer is not in a fixed position; it swings through a 60 degree sector to provide a two-dimensional image of the eye.
UBM
The UBM is a high frequency/high resolution ultrasound device, designed to provide highly detailed information about the anterior segment of the eye. The UBM is used for glaucoma evaluation, tumor evaluation and differentiation, pre- and post-intraocular lens implantation and corneal refractive surgery. The device allows the surgeons to perform precise measurements within the anterior chamber of the eye.
Pachymeters
The pachymeter uses the same principles as the A-Scan, but the system is tailored to measure
the thickness of the cornea. Central corneal thickness is used in the calculation of intraocular pressure. Pachymetry is also used by refractive surgeons to screen candidates and help plan surgery.
Ispan Intraocular Gases
The Company distributes two intraocular gas products C3F8 and SF6, which are used by vitreoretinal surgeons as a temporary tamponade in detached retina surgery. Under a non-exclusive distribution agreement with AirGas, Inc. (AirGas"), the Company distributes packages of AirGas gases in canisters containing up to 25 grams of gas. Along with the intraocular gases, the Company
manufactures and distributes a patented disposable universal gas kit, which delivers the gas from the canister to the patient.
Surgical Packs
The Company markets disposable surgical packs used in vitreoretinal surgery, including packs which aid surgeons in the process of injecting and extracting silicone oil.
AXIS Image Management
The AXIS Image Management system easily manages ophthalmic diagnostic images via a web browser from any device regardless of modality, device manufacturer or location.
Research and Development
The
development of ultrasound ophthalmic equipment and AXIS Image Management system are performed at the Company’s Lake Success, New York. Company-sponsored research and development expenditures from operations for the fiscal years ended June 30, 2022 and 2021 were approximately $991,000 and $890,000, respectively.
Manufacturing and Distribution
The Company assembles and distributes its ophthalmic surgical products at its 7,440 square foot leased facility in New Berlin, WI. The
Company designs, assembles, and services its ophthalmic ultrasound products at its 6,278 square foot leased facility in Lake Success, NY. In addition to performing its own assembly, the Company subcontracts component manufacturing, sterilization, and other services to various qualified vendors.
The Company has registered its facilities with the FDA and has attained ISO 13485 certification for its facilities and medical devices. ISO 13485 requires an implemented quality system that applies to product design, manufacture, installation, and servicing. Certification can be obtained only after an audit of a company’s quality system by a qualified independent outside auditor and requires regular reexamination. The
Company has obtained European Community certification (“CE-Mark”) for many of its medical devices.
The manufacture, testing, and marketing of each of the Company’s products entails risk of product liability. The Company carries product liability insurance to cover primary risk.
Governmental Regulations
The Company’s products are subject to stringent ongoing regulation by the FDA and similar health authorities, and if these governmental approvals or clearances of the
Company’s products are restricted or revoked, the Company could face delays that would impair the Company’s ability to generate funds from operations.
The Company has received the necessary FDA and other necessary regulations clearances and approvals for all products that the Company currently markets. The FDA and comparable agencies in state and local jurisdictions and in foreign countries
3
impose
substantial requirements upon the manufacturing and marketing of pharmaceutical and medical device equipment and related disposables, including the obligation to adhere to the FDA’s Good Manufacturing Practice regulations. Compliance with these regulations requires detailed validation of manufacturing and quality control practices, FDA periodic inspections and other procedures. If the FDA finds any deficiencies the FDA may impose restrictions on marketing the specific products until such deficiencies are corrected.
The FDA and similar health authorities in foreign countries extensively regulate the Company’s activities. The Company must obtain either 510(K) clearances or pre-market approvals and new drug application approvals
prior to marketing a product in the United States. Foreign regulation also requires that the Company obtain other approvals from foreign government agencies prior to the sale of products in those countries. Also, 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 has received CE approval on several of the Company’s products that allows the Company to
sell the products in the countries comprising the European Community. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements. In addition to the CE mark, some foreign countries require separate individual foreign regulatory clearances.
Marketing and Sales
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.
Service and Support
The
Company maintains a full-service program for all products sold. The Company provides limited warranties on all products against defects and performance. Product repairs are made at the Company's New York facility for ultrasound products. Service support for AXIS Imaging Management and surgical products are provided remotely.
Patents, Trademarks and Licenses
The pharmaceutical and medical device communities place considerable importance on obtaining patent and trade secret protection for new technologies, products and processes for the purpose of strengthening the Company’s position in
the market place and protecting the Company’s economic interests. The Company’s policy is to protect its technology by aggressively obtaining patent protection for substantially all of its developments and products, both in the United States and in selected countries outside the United States. It is the Company’s policy to file for patent protection in those foreign countries in which the Company believes such protection is necessary to protect its economic interests. The duration of the Company’s patents, trademarks and licenses vary through 2027. The
Company has 2 United States patents that cover the Company’s technology. The Company believes that the impact of the patents is minimal in that our current products and revenue are driven less by our patents and more by our knowledge and trade secrets.
The Company intends to vigorously defend its patents if the need arises.
Competition
There are numerous direct and indirect competitors of the Company in the United States
and abroad. These 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.
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. The ophthalmic market in general is intensely competitive, with each company eager to expand its market share. The Company’s strategy is to compete primarily on the basis of technological innovation to which it has proprietary rights. The
Company believes, therefore, that its business will depend in large part on protecting its intellectual property through maintaining trade secrets, patents, and other governmental regulations.
Sonomed’s principal competitors are Quantel, Inc., and Accutome, Inc.. Sonomed has had a leading presence in the ophthalmic ultrasound industry for over 30 years. Management believes that this has helped Sonomed build a reputation as a long-standing operation that provides a quality product, which has enabled the Company to establish effective distribution coverage throughout the world. Various competitors offering similar products at a lower price could threaten Sonomed’s market position. The development of optical technologies for ophthalmic biometrics and imaging may also diminish the
Company’s
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market position. This equipment can be used instead of ultrasound equipment in certain applications with some advantage. Such equipment, however, is more expensive.
Trek’s competitor for the ISPAN® gases is Alcon Laboratories. Trek’s competitors for its surgical packs include Alcon Laboratories and Bausch & Lomb. To remain competitive, the Company needs to maintain a low-cost operation. There are numerous other companies that can provide this manufacturing service.
EMI’s
principal competitors are Carl Zeiss Meditec Inc. and Topcon Healthcare Solutions. The Company believes it establishes competitive advantage by offering technical innovation, product features, low total cost of ownership, and capable and responsive technical support.
Human Capital
As of June 30, 2022, the Company employed 41 employees. Of these employees, 22 of the Company’s employees are employed in manufacturing, 14 are employed in general and administrative positions, 4 are employed in sales and marketing and 1 is employed in research and
development. The Company’s employees are not covered by a collective bargaining agreement, and the Company considers its relationship with its employees to be good.
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ITEM 1A. RISK FACTORS
In addition to other information contained in this report on Form 10-K, the following Risk Factors should be considered carefully in evaluating our business. If any of the following risks actually occur, our financial condition
and results of operations could be materially and adversely affected.
Financial Risks
Due to the Company’s history of operating losses, we received a going concern opinion from our independent registered public accounting firm.
Our operations are subject to a number of factors that can affect our operating results and financial condition. Such factors include, but are not limited to: the continuous enhancement of the current products, development of new products; changes in domestic and foreign regulations; ability of manufacture successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, our products and our ability to raise capital to support
our operations.
To date, our operations have not generated sufficient revenues to enable profitability. As of June 30, 2022, we had an accumulated deficit of $i68.9 million, and incurred recurring losses from operations and negative cash flows from operating activities in the current and in prior years. These factors raise substantial doubt regarding our ability to continue as a going concern.
As
a result of above matters, our independent auditors have indicated in their report on our June 30, 2022 financial statements that there is substantial doubt about our ability to continue as a going concern. A "going concern" opinion indicates that the financial statements have been prepared assuming we will continue as a going concern and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets, or the amounts and classification of liabilities that may result if we do not continue as a going concern. Therefore, you should not rely on our consolidated balance sheet as an indication of the amount of proceeds that would be available to satisfy claims of our creditors, and potentially be available for distribution to our stockholders, in the event of liquidation.
Our continued
operations will ultimately depend on the ability to be profitable from our operations and the on-going support of our shareholders and creditors.
There are inherent uncertainties involved in estimates, judgments and assumptions used in the preparation of financial statements in accordance with United States GAAP. Any changes in estimates, judgments and assumptions used could have a material adverse effect on the Company’s business, financial position and operating results.
The consolidated financial statements included in the periodic reports the Company files with the SEC are prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP. The preparation of financial
statements in accordance with GAAP involves making estimates, judgments and assumptions that affect reported amounts of assets (including intangible assets), liabilities and inventories, revenues, expenses and income. This includes estimates, judgments and assumptions for assessing the recoverability of the Company’s other intangible assets, pursuant to Financial Accounting Standards Board (“FASB”) issued authoritative guidance. If any estimates, judgments or assumptions change in the future, the Company may be required to record additional expenses or impairment charges. Any resulting expense or impairment loss would be recorded as a charge against the Company's earnings and could have a material adverse impact
on the Company's financial condition and operating results. Estimates, judgments and assumptions are inherently subject to change in the future, and any such changes could result in corresponding changes to the amounts of assets (including goodwill and other intangible assets), liabilities, revenues, expenses and income. Any such changes could have a material adverse effect on the Company’s financial position and operating results.
On an on-going basis, the Company evaluates its estimates, including, among others, those relating to:
•sales returns;
•allowances
for doubtful accounts;
•inventories
•intangible assets;
•right-of-use assets
•income and other tax accruals;
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•deferred tax asset valuation allowances;
•sales discounts;
•warranty obligations;
•contingencies and litigation.
The
Company bases its estimates on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. The Company’s assumptions and estimates may, however, prove to have been incorrect and the Company’s actual results may differ from these estimates under different assumptions or conditions. While the Company believes the assumptions and estimates it makes are reasonable, any changes to the
Company’s assumptions or estimates, or any actual results which differ from the Company’s assumptions or estimates, could have a material adverse effect on the Company’s financial position and operating results. Improper design and implementation of internal control related to the estimates could result in misstatement of financial reports.
Operational Risk
Any acquisitions, strategic alliances, joint ventures and divestitures that the Company effects, if any, could result in financial results that differ from market expectations.
In the normal course of business, the
Company engages in discussions with third parties regarding possible acquisitions, strategic alliances, joint ventures and divestitures. As a result of any such transactions, of which the Company cannot assure that any will occur, the Company’s financial results may differ from the investment community’s expectations in a given quarter. In addition, acquisitions and alliances may require the Company to integrate a different company culture, management team, business infrastructure, accounting systems and financial reporting systems. The Company may not be able to effect any such acquisitions or alliances. The
Company may have difficulty developing, manufacturing and marketing the products of a newly acquired business in a way that enhances the performance of the Company’s combined businesses or product lines to realize the value from any expected synergies. Depending on the size and complexity of an acquisition, the Company’s successful integration of the entity depends on a variety of factors, including the retention of key employees and the management of facilities and employees in separate geographical areas. These efforts require varying levels of management resources, which may divert the Company’s attention from other business operations. Also, the
Company’s results may be adversely impacted because of acquisition-related costs, amortization costs for certain intangible assets and impairment losses related to goodwill in connection with such transactions. Finally, acquisitions or alliances by the Company may not occur, which could impair the Company’s growth.
The Company’s results fluctuate from quarter to quarter.
The Company has experienced quarterly fluctuations in operating results and anticipates continued fluctuations in the future. A number of factors contribute to these fluctuations:
•The
timing and expense of new product introductions by the Company or its competitors, although the Company might not successfully develop new products and any such new products may not gain market acceptance;
•The cancellation or delays in the purchase of the Company’s products;
•Fluctuations in customer demand for the Company’s products;
•Changes in domestic and foreign regulations;
•The
gain or loss of significant customers;
•Changes in the mix of products sold by the Company;
•Competitive pressures on prices at which the Company can sell its products;
•Announcements of new strategic relationships by the Company or its competitors;
•Litigation costs and settlements; and
•General economic conditions and other external factors such as energy costs.
The
Company sets its spending levels in advance of each quarter based, in part, on the Company’s expectations of product orders and shipments during that quarter. A shortfall in revenue, therefore, in any particular quarter as compared to the Company’s plan could have a material adverse impact on the Company’s results of operations and cash flows.
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Also, the Company’s quarterly results could fluctuate due to general market conditions in
the healthcare industry or global economy generally, or market volatility unrelated to the Company’s business and operating results.
Failure of the market to accept the Company’s products could adversely impact the Company’s business and financial condition.
The Company’s business and financial condition will depend in part upon the market acceptance of the Company’s products. The Company’s
products may not achieve or maintain market acceptance. Market acceptance depends on a number of factors including:
•The price of the products;
•The continued receipt of regulatory approvals for multiple indications;
•The establishment and demonstration of the clinical safety and efficacy of the Company’s products; and
•The advantages of the Company’s products over those marketed by the Company’s competitors.
Any
failure to achieve or maintain significant market acceptance of the Company’s products will have a material adverse impact on the Company’s business.
The success of products with which the Company’s products compete could have an adverse impact on the Company’s business.
The Company faces intense competition in the medical device and pharmaceutical markets, which are characterized by rapidly changing technology, short product life cycles, cyclical oversupply and rapid
price erosion. Many of the Company’s competitors have substantially greater financial, technical, marketing, distribution and other resources. The Company’s strategy is to compete primarily on the basis of technological innovation, reliability, quality and price of the Company’s products. Without timely introductions of new products and enhancements, the Company’s products will become technologically obsolete over time, in which case the Company’s revenues and operating results would suffer. The success of the
Company’s new product offerings will depend on several factors, including 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;
•Anticipate competitors’ announcements of new products, services or technological innovations; and
•Anticipate
general market and economic conditions.
The Company may not be able to compete effectively in the competitive environments in which the Company operates.
Lack of availability of key system components could result in delays, increased costs or costly redesign of the Company’s products.
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 the Company’s components and outsourced finished goods from single sources in an effort to obtain volume discounts. 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. Any loss of availability of an essential component or finished good could result in a material adverse change to the Company’s business, financial condition and results of operations. Some of the Company’s suppliers are subject to the FDA’s Good Manufacturing Practice regulations. Failure of these suppliers to comply with those regulations
could result in the delay or limitation of the supply of parts or components to the Company, which would adversely impact the Company’s financial condition and results of operations.
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The supply chain challenges could increase the costs of products and the numbers of backorders and could adversely affect our results of operations.
The Company is dependent on its management and key personnel to succeed.
The
Company’s principal executive officers and technical personnel have extensive experience with the Company’s products, the Company’s research and development efforts, the development of marketing and sales programs and the necessary support services to be provided to the Company’s customers. Also, the Company competes with other companies, universities, research entities and other organizations to attract and retain qualified personnel. The loss of the services of any of the Company’s executive officers or other technical personnel, or the
Company’s failure to attract and retain other skilled and experienced personnel, could have a material adverse impact on the Company’s ability to maintain or expand businesses.
Legal, Regulatory and Global
The Company’s products are subject to stringent ongoing regulation by the FDA and similar domestic and foreign health care regulatory authorities, and if the regulatory approvals or clearances of the Company’s products are restricted or revoked, the Company could face delays that would impair the
Company’s ability to generate funds from operations.
The FDA and similar health care regulatory authorities in foreign countries extensively regulate the Company’s activities. The Company must obtain either 510(K) clearances or pre-market approvals and new drug application approvals prior to marketing any products in the United States. Foreign regulation also requires that the Company obtain other approvals from foreign government agencies prior to the sale of products in those countries. Also, the Company may be required to obtain FDA approval before exporting a product or device that has
not received FDA marketing clearance or approval.
The Company has received the necessary FDA approvals for all products that the Company currently markets in the United States. Any restrictions on or revocation of the FDA approvals and clearances that the Company has obtained, however, would prevent the continued marketing of the impacted products and other devices. The restrictions or revocations could result from the discovery of previously unknown problems with the product. Consequently, FDA revocation would impair the Company’s ability to generate funds from operations.
The
FDA and comparable agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the manufacturing and marketing of pharmaceutical and medical device equipment and related disposables, including the obligation to adhere to the FDA’s Good Manufacturing Practice regulations. Compliance with these regulations requires time-consuming detailed validation of manufacturing and quality control processes, FDA periodic inspections and other procedures. If the FDA finds any deficiencies in the validation processes, for example, the FDA may impose restrictions on marketing the specific products until such deficiencies are corrected.
The Company has received CE approval on several of the Company’s products that allows the
Company to sell the products in the countries comprising the European Community. In addition to the CE mark, however, some foreign countries may require separate individual foreign regulatory clearances. The Company may not be able to obtain regulatory clearances for other products in the United States or foreign markets.
The process for obtaining regulatory clearances and approvals underlying clinical studies for any new products or devices and for multiple indications for existing products is lengthy and will require substantial commitments of Company’s financial resources and Company’s management’s time and effort. Any delay in obtaining clearances or approvals or any changes in existing regulatory requirements would materially adversely impact the Company’s
business.
The Company’s failure to comply with the applicable regulations would subject the Company to fines, delays or suspensions of approvals or clearances, seizures or recalls of products, operating restrictions, injunctions or civil or criminal penalties, which would adversely impact the Company’s business, financial condition and results of operations.
The Company’s products employ proprietary technology, and this technology may infringe on the intellectual property rights of third parties.
The
Company holds several United States and foreign patents for the Company’s products. Other parties, however, hold patents relating to similar products and technologies. If patents held by others were adjudged valid and interpreted broadly in an adversarial proceeding, the court or agency could deem them to cover one or more aspects of the
9
Company’s products or procedures. Any claims for patent infringements or claims by the Company for patent enforcement would consume time, result in costly litigation, divert technical
and management personnel or require the Company to develop non-infringing technology or enter into royalty or licensing agreements. The Company may become subject to one or more claims for patent infringement. The Company may not prevail in any such action, and the Company’s patents may not afford protection against competitors with similar technology.
If a court determines that any of the Company’s products infringes, directly or indirectly, on a patent in a particular market, the court may enjoin the
Company from making, using or selling the product. Furthermore, the Company may be required to pay damages or obtain a royalty-bearing license, if available, on acceptable terms.
The Company’s ability to market or sell the Company’s products may be adversely impacted by limitations on reimbursements by government programs, private insurance plans and other third party payers.
The Company’s customers bill various third party payers, including government programs and private insurance plans, for the health care services provided to their patients.
Third party payers may reimburse the customer, usually at a fixed rate based on the procedure performed, or may deny reimbursement if they determine that the use of the Company’s products was elective, unnecessary, inappropriate, not cost-effective, experimental or used for a non-approved indication. Third party payers may deny reimbursement notwithstanding FDA approval or clearance of a product and may challenge the prices charged for the medical products and services. The Company’s ability to sell the Company’s products on a profitable basis may be adversely impacted by denials of reimbursement or limitations on reimbursement, compared with reimbursement available for competitive products and procedures. New legislation
that further reduces reimbursements under the capital cost pass-through system utilized in connection with the Medicare program could also adversely impact the marketing of the Company’s products.
The Company may become involved in product liability litigation, which may subject the Company to liability and divert management attention.
The testing and marketing of the Company’s products entails an inherent risk of product liability, resulting in claims based upon injuries or alleged injuries or a failure to
diagnose associated with a product defect. Some of these injuries may not become evident for a number of years. Although the Company is not currently involved in any product liability litigation, the Company may be party to litigation in the future as a result of an alleged claim. Litigation, regardless of the merits of the claim or outcome, could consume a great deal of the Company’s time and attention away from the Company’s core businesses. The Company maintains limited product liability insurance coverage of $1,000,000 per occurrence and $2,000,000
in the aggregate, with umbrella policy coverage of $5,000,000 in excess of such amounts. 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’s product liability insurance coverage may not continue to be available to the Company in the future on reasonable terms or at all.
The Company’s international operations could be adversely impacted by changes in laws or policies of foreign governmental agencies and social and economic conditions in the countries in which the
Company operates.
The Company derives a portion of its revenue from sales outside the United States. Changes in the laws or policies of governmental agencies, as well as social and economic conditions, in the countries in which the Company operates could impact the Company’s business in these countries and the Company’s results of operations. Also, economic factors, including inflation and fluctuations in interest rates and foreign currency exchange rates, and competitive factors such as price competition, business combinations of competitors or a decline in industry sales from continued
economic weakness, both in the United States and other countries in which the Company conducts business, could adversely impact the Company’s results of operations.
The impact of terrorism or acts of war could have a material adverse impact on the Company’s business.
Terrorist acts or acts of war, whether in the United States or abroad, could cause damage or disruption to the Company’s operations, its suppliers, channels to market or customers, or could cause costs to increase, or create political or economic instability, any of which could have
a material adverse impact on the Company’s business.
In February 2022, Russia invaded Ukraine. As military activity proceeds and sanctions, export controls and other measures are imposed by many countries against Russia, Belarus and specific areas of Ukraine, the war is increasingly affecting the global economy and financial markets, as well as exacerbating ongoing economic challenges, including rising inflation and global supply-chain disruption. The Company has operations or activities in countries and regions outside the United States. As a result, its global operations are affected by economic, political and other
10
conditions
in the foreign countries in which it does business as well as U.S. laws regulating international trade, although the Company has not yet assessed that the war has had a material effect on its financial position or results of operations.
The Company’s charter documents and Pennsylvania law may inhibit a takeover.
Certain provisions of Pennsylvania law and the Company’s Bylaws could delay or impede the removal of incumbent directors and could make it more difficult for a third party
to acquire, or discourage a third party from attempting to acquire, control of the Company. These provisions could limit the share price that certain investors might be willing to pay in the future for shares of the Company’s common stock. The Company’s Board of Directors is divided into three classes, with directors in each class elected for three-year terms. The Bylaws impose various procedural and other requirements that could make it more difficult for shareholders to effect certain corporate actions. The Company’s Board of Directors may issue
shares of preferred stock without shareholder approval on such terms and conditions, and having such rights, privileges and preferences, as the Board may determine. The rights of the holders of common stock will be subject to, and may be adversely impacted by, the rights of the holders of any preferred stock that may be issued in the future.
Healthcare policy changes, including pending proposals to reform the U.S. healthcare system and implementation of the Affordable Healthcare Act, may have a material adverse effect on the Company.
Healthcare costs have risen significantly over the past decade. There have been and continue to be proposals by legislators, regulators and third-party payors to keep these costs down. Certain proposals, if passed, would impose limitations on the prices the
Company will be able to charge for the Company’s products, or the amounts of reimbursement available for its products from governmental agencies or third-party payers. These limitations could have a material adverse effect on the Company’s financial position and results of operations.
Changes in the healthcare industry in the U.S. and elsewhere could adversely affect the demand for the Company’s products as well as the way in which the Company conducts the Company’s business. The 2010 Affordable Care Act
provides that most individuals must have health insurance, establishes new regulations on health plans, and creates insurance pooling mechanisms and other expanded public health care measures.
The Company anticipates that the healthcare reform legislation will further reduce Medicare spending on services provided by hospitals and other providers and further forms sales or excise tax on the medical device manufacturing sector. Various healthcare reform proposals have also emerged at the federal and state level. The Company cannot predict what healthcare initiatives, if any, will be implemented at the federal or state level, or the effect any future legislation or regulation will have on the
Company. However, an expansion in government’s role in the U.S. healthcare industry may lower reimbursements for the Company’s products, reduce medical procedure volumes and adversely affect the Company’s business, possibly materially.
Future legislation or changes in government programs may adversely impact the market for the Company’s products.
From time to time, the federal government and Congress have made proposals to change aspects of the delivery and financing of health care services. The Company cannot predict what form any future legislation
or regulation may take or its impact on the Company’s business. Legislation that sets price limits and utilization controls adversely impact the rate of growth of the markets in which the Company participates. If any future health care legislation or regulations were to adversely impact those markets, the Company’s product marketing could also suffer, which would adversely impact the Company’s business.
Information Security, cybersecurity and Data Privacy Risks
Cybersecurity incidents could disrupt business operations, result in the loss of critical
and confidential information and adversely impact the Company's reputation and results of operations.
The Company is subject to cyber security risks and may incur increasing costs in efforts to minimize those risks and to comply with regulatory standards. The Company employs information technology systems and Internet systems, including websites, which allow for the secure storage and transmission of proprietary or confidential information regarding the
Company’s customers, employees and others, including credit card information and personal identification information. The Company has made significant efforts to secure its computer network to mitigate the risk of possible cyber-attacks and is continuously working to upgrade its existing information technology systems and provide employee awareness training around phishing, malware, and other cyber risks to ensure that the Company is protected, to the
11
greatest extent possible, against cyber risks and security breaches. Despite these efforts security of the
Company’s computer networks could be compromised which could impact operations and confidential information could be misappropriated, which could lead to negative publicity, loss of sales and profits or cause the Company to incur significant costs to reimburse third-parties for damages which could adversely impact profits.
Other
The Company’s Chairman and Chief Executive Officer, Richard DePiano Jr. is the Company’s controlling shareholder and has sufficient voting power to determine the outcome of all matters submitted to the
Company’s shareholders for approval.
In February 2018, the Company entered into a Debt Exchange Agreement (the "Exchange Agreement") with Mr. DePiano Sr. and DP Associates Inc. Profit-Sharing Plan of which Mr. DePiano is the sole owner and sole trustee (the "Holders"). Pursuant to the terms of the Exchange Agreement, the Holders exchanged a total of $645,000 principal amount of debt the Company owed the Holders under factoring agreements and notes (the "Notes") the Company entered into with the Holders in February and March of 2016 for 2,000,000 shares of Series A Convertible Preferred Stock (the "Preferred Stock"). Each share the Preferred
Stock entitles the Holder thereof to 13 votes per share and will vote together with all other classes and series of stock of the Company as a single class on all actions to be taken by the Company’s stockholders. As a result of this voting power, the Holders currently beneficially own approximately 77.81% of the voting power on all actions to be taken by the Company’s shareholders. If the Holders were to convert their shares of Preferred Stock into common stock at the current conversion ratio, the Holders would receive a total of 4,300,000 shares of Common Stock, or approximately 36.70% of the currently outstanding shares of Common Stock assuming such conversion.
The
Holders, therefore, control the election of all of the members of the Company’s board of directors and control the outcome of any corporate transaction or other matter submitted to a vote of the Company’s shareholders for approval, including mergers or other acquisition proposals and the sale of all or substantially all of the Company’s assets, in each case regardless of how all of the Company’s shareholders other than the Holders vote their shares. The interests of the Holders in maintaining this voting control of the Company may have an adverse effect
on the price of the Company’s common stock because of the absence of any potential “takeover” premium and may, therefore, be inconsistent with the interest of the Company’s shareholders other than the Holders. The voting control by the Holders could also discourage a third party from attempting to acquire control of the Company and may make it more difficult for a third party to acquire control of the Company. Mr. DePiano Sr. passed away on October 3, 2019 and left a will by which he appointed Richard
J. DePiano, Jr., the Chief Executive Officer of the Company, as executor. Richard DePiano Jr. was elected to serve as chairman of the Company's board. Mr. DePiano, Jr. qualified as executor and has control over the listed shares in his capacity as executor of Mr. DePiano Sr.'s estate.
The market price of the Company’s stock has historically been volatile, and the Company has not paid cash dividends.
The volatility of the Company’s common stock imposes a greater
risk of capital losses on shareholders as compared to less volatile stocks. In addition, such volatility makes it difficult to ascribe a stable valuation to a shareholder’s holdings of the Company’s common stock. The following factors have and may continue to have a significant impact on the market price of the Company’s common stock:
•Acquisitions, strategic alliances, joint ventures and divestitures that the Company effects, if any;
•Announcements of technological innovations;
•Changes
in marketing, product pricing and sales strategies or new products by the Company’s competitors;
•Changes in domestic or foreign governmental regulations or regulatory requirements; and
•Developments or disputes relating to patent or proprietary rights and public concern as to the safety and efficacy of the procedures for which the Company’s products are used.
Moreover, the possibility exists that the stock market, and in particular the securities of technology companies such as the Company, could experience extreme price and volume fluctuations
unrelated to operating performance.
The Company has not paid cash dividends on its common stock and does not anticipate paying cash dividends in the foreseeable future.
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If the Company raises funds in the future, the Company may be required to raise those funds through public or private financings, strategic relationships or other arrangements at prices and other terms that may not be favorable. The sale of additional equity and debt securities may result in additional dilution
to the Company’s shareholders. Additional financing may not be available in amounts or on terms acceptable to the Company or at all.
COVID-19 could negatively impact the demand, interrupt the supply and operations and effect the liquidity.
On March 11, 2020, the World Health Organization declared the outbreak of a coronavirus (COVID-19) a pandemic. This pandemic has had a significant impact on the global and domestic economy, and is likely to impact the operations of the Company. The
Company has been assessing the impact of the COVID-19 pandemic on the business, including the impact on the financial condition and results of operations, financial resources, changes in accounting judgment as well as the impact on the supply and demand, etc. The Company is considered an essential business and has been able to maintain operations during the lockdown. The Company remains in strong communications with the customers and there is no evidence showing that COVID-19 will greatly affect collection of accounts receivable as the date of this filing. However, the Company does not know the extent and duration of the impact of COVID-19 on its business due to the uncertainty about the spread of the virus.
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ITEM
1B. UNSOLVED SEC STAFF COMMENTS
The Company does not believe there are any unresolved SEC staff comments.
ITEM 2. PROPERTIES
As of June 30, 2022the Company leased an aggregate of 16,354 square feet of space for its (i) corporate offices in Wayne, Pennsylvania, (ii) Sonomed's manufacturing facility in Lake Success, New York, and (iii) Trek’s distribution facility in New Berlin, Wisconsin. The
Company's current corporate office lease of 2,186 square feet will expire on December 2024. The New York facility lease of 6,728 square feet will expire on December 31, 2024. The Company extended lease agreement for its Wisconsin warehouse of 7,440 square feet, which ended in April 30, 2022 for a term of three years. The new lease agreement has a lease right-of-use ("ROU") assets and lease liability of approximately $224,000, respectively. The Company classified the amended lease as an operating lease under ASC 842.
ITEM
3. LEGAL PROCEEDINGS
The Company, from time to time is involved in various legal proceedings and disputes that arise in the normal course of business. These matters have previously and could pertain to intellectual property disputes, commercial contract disputes, employment disputes, and other matters. The Company does not believe that the resolution of any of these matters has had or is likely to have a material adverse impact on the Company’s business, financial condition or results of operations.
ITEM
4. MINE SAFETY DISCLOSURES
Not applicable
Part II.
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
The Company’s common stock trades on the OTCQB Market under the symbol “ESMC.” Any over the counter market quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission
and may not present actual transactions.
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.
The
Company’s forecast of the period of time through which its financial resources will be adequate to support its operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed in “Risk Factors” included in this Form 10-K. If the Company raises funds in the future, the Company may be required to raise those funds through public or private financings, strategic relationships or other arrangements at prices and other terms that may not be as favorable as they would without such qualification. The sale of additional equity and debt securities may result in additional dilution to the Company’s shareholders.
Additional financing may not be available in amounts or on terms acceptable to the Company or at all.
ITEM 6. [Reserved]
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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The
following discussion and analysis should be read together with the consolidated financial statements and notes thereto and other financial information contained elsewhere in this Form 10-K and the discussion under “Risk Factors” included in Item 1A of this Form 10-K.
•Consolidated net revenue increased approximately $231,000 or 2.2%, to $10,703,000 during the year ended June 30, 2022 as compared to the prior fiscal year. The increase in net revenue is attributed to an increase of approximately $846,000 in sales of Sonomed's ultrasound products mainly due to increased sales in Europe and Middle East. The increase is offset by a decrease of approximately $384,000 in sales of Trek products, a decrease of $201,000 in the service plans when a large contract
was terminated during the year ended June 30, 2022 and a decrease of $30,000 of other Digital revenue.
•Consolidated cost of goods sold totaled approximately $6,096,000, or 57.0%, of total revenue during the year ended June 30, 2022, as compared to $6,044,000, or 57.7%, of total revenue of the prior fiscal year. The decrease of 0.7% in cost of goods sold as a percentage of total revenue is mainly due to change of product mix.
•Consolidated marketing, general and administrative expenses increased $516,000, or 14.5%, to $4,086,000 during the year ended June 30, 2022, as compared to the prior fiscal year. The
increase in marketing, general and administrative expenses is mainly due to increased consulting expense related to AXIS regulatory filing, trade show expenses, travel expense, increased headcount and network expense. The increase to accounts receivable allowance of $155,000 for year ended June 30, 2022 based on the Company’s historical trends, specific customer issues and current economic trends also contributed to the increase in marketing, general and administrative expenses.
•Consolidated research and development expenses increased $101,000 or 11.3%, to $991,000 during the year ended June 30, 2022 as compared to the same period
of the prior fiscal year. Research and development expenses were primarily expenses associated with the introduction of new or enhanced products. The increase in research and development expense is mainly due to mainly due to increased consulting expense in year ended June 30, 2022.
The following table
shows consolidated net revenue, as well as identifying trends in revenues for the years ended June 30, 2022 and 2021. Table amounts are in thousands:
Consolidated
net revenue increased approximately $231,000 or 2.2%, to $10,703,000 during the year ended June 30, 2022 as compared to the prior fiscal year. The increase in net revenue is attributed to an increase of approximately $846,000 in sales of Sonomed's ultrasound products mainly due to increased sales in Europe and Middle East. The increase is offset by a decrease of approximately $384,000 in sales of Trek products, a decrease of $201,000 in the service plans when a large contract was terminated during the year ended June 30, 2022, and a decrease of $30,000 of other Digital revenue.
Foreign sales
The following table presents domestic and international
sales from continuing operations. Table amounts are in thousands:
The
following table presents consolidated cost of goods sold and as a percentage of revenues for the years ended June 30, 2022 and 2021. Table amounts are in thousands:
Consolidated
cost of goods sold totaled approximately $6,096,000, or 57.0%, of total revenue during the year ended June 30, 2022, as compared to $6,044,000, or 57.7%, of total revenue of the prior fiscal year. The decrease of 0.7% in cost of goods sold as a percentage of total revenue is mainly due to change of product mix.
The following table presents consolidated marketing, general and administrative expenses for the years ended June 30, 2022 and 2021. Table amounts are in thousands:
Consolidated
marketing, general and administrative expenses increased $516,000, or 14.5%, to $4,086,000 during the year ended June 30, 2022 as compared to the prior fiscal year. The increase in marketing, general and administrative expenses is mainly due to increased consulting expense related to AXIS regulatory filing, trade show expenses, travel expense, increased payroll and network expense. The increase to accounts receivable allowance of $155,000 for year ended June 30, 2022 based on the Company’s historical trends, specific customer issues and current economic trends also contributed to the increase in marketing, general and administrative expenses.
The following table presents consolidated research and
development expenses for the years ended June 30, 2022 and 2021.
Consolidated
research and development expenses increased $101,000, or 11.3%, to $991,000 during the year ended June 30, 2022 as compared to the prior fiscal year. Research and development expenses were primarily expenses associated with the introduction of new or enhanced products. The increase in research and development expense is mainly due to increased consulting expense in year ended June 30, 2022.
Other income (expense)
On April 27, 2020, the Company entered into a PPP loan for $500,000 in connection with the CARES Act related to COVID-19. The promissory
note has a fixed payment schedule. The Company submitted the loan forgiveness application on August 2, 2021. The full amount of the PPP loan and accrued interest of $6,305 were forgiven on August 13, 2021and reported as other income during the year ended June 30, 2022.
Russia-Ukraine War
In February 2022, Russia invaded Ukraine. As military activity proceeds and sanctions, export controls and other measures are imposed by many countries against Russia, Belarus and specific areas of Ukraine,
the war is increasingly affecting the global economy and financial markets, as well as exacerbating ongoing economic challenges, including rising inflation and global supply-chain disruption. The Company has operations or activities in countries and regions outside the United States. As a result, its global operations are affected by economic, political and other conditions in the foreign countries in which it does business as well as U.S. laws regulating international trade, although the Company has not yet assessed that the war has had a material effect on its financial position or results of operations.
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Liquidity
and Capital Resources
Our total cash on hand as of June 30, 2022 was approximately $594,000 of cash on hand and restricted cash of approximately $256,000 compared to approximately $1,651,000 of cash on hand and restricted cash of $256,000 as of June 30, 2021. Approximately $48,000 was available under our line of credit as of June 30, 2022.
Because our operations have not historically generated sufficient revenues to enable profitability we will continue to monitor costs and expenses closely and may need to raise additional capital in order to fund operations.
We expect to continue
to fund operations from cash on hand and through capital raising sources if possible and available, which may be dilutive to existing stockholders, through revenues from the licensing of our products, or through strategic alliances. Additionally, we may seek to sell additional equity or debt securities through one or more discrete transactions, or enter into a strategic alliance arrangement, but can provide no assurances that any such financing or strategic alliance arrangement will be available on acceptable terms, or at all. Moreover, the incurrence of indebtedness in connection with a debt financing would result in increased fixed obligations and could contain covenants that would restrict our operations.
As of June 30, 2022 we had an accumulated deficit of approximately $68.9 million, incurred recurring losses from operations and negative
cash flows from operating activities in current year and as well as in prior years. These factors raise substantial doubt regarding our ability to continue as a going concern, and our ability to generate cash to meet our cash requirements for the following twelve months as of the filing date of this form 10-K.
The following table presents overall liquidity and capital resources as of June 30, 2022 and 2021. Table amounts are in thousands:
Line of credit, note payable, lease liabilities, PPP loan and EIDL loan
$1,205
$1,772
Total
debt
1,205
1,772
Total equity
1,478
1,460
Total capital
$2,683
$3,232
Total debt to total capital
44.9%
54.8%
Working
Capital Position
Working capital decreased approximately $12,000 to $1,184,000 as of June 30, 2022, and the current ratio increased to 1.39 to 1 to 1 from 1.35 to 1 when compared to June 30, 2021.
The decrease in working capital is due to a decrease in current liabilities of $395,000, offset by a decrease in current assets of approximately $407,000 mainly due to the PPP loan forgiveness as of June 30, 2022, offset by the operating loss in the current year and investment in inventory and accounts receivable.
Debt to total capital ratio was 44.9% and 54.8% as of June 30, 2022 and June 30,
2021, respectively.
Cash Flow Provided By (Used In) Operating Activities
During year ended June 30, 2022the Company used approximately $1,050,000 of cash in operating activities as compared to approximately $839,000 of cash provided by operating activities during the year ended June 30, 2021.
For the year ended June 30, 2022, its cash used in operations is mainly due to non cash other income of $506,000, an increase in inventory of $187,000, an increase in accounts receivable of
$615,000, and a decrease in accounts payable of $90,000. The cash outflow is offset by an increase in accrued expense of $218,000. The remaining offsetting items for cash used in operations is comprised of less significant items.
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For the year ended June 30, 2021, its cash provided by operations is mainly due to a decrease in inventory of $368,000, a decrease in accounts receivable of $221,000, and an increase in accounts payable of $342,000. The cash inflow is offset by a decrease in deferred revenue of $152,000. The remaining offsetting items for cash provided by operations is comprised of less significant items.
Cash
Flows Used In Investing Activities
There was no cash flow used in investing activities for the year ended June 30, 2022. Cash flow used in investing activities for the year ended June 30, 2021 were due to purchase of equipment of $9,000.
Any necessary capital expenditures have generally been funded out of cash from operations, and the Company is not aware of any factors that would cause historical capital expenditure levels to not be indicative of capital expenditures in the future and, accordingly, does not believe that the Company will have to commit material resources to capital investment
for the foreseeable future.
Cash Flows Used in Financing Activities
For the year ended June 30, 2022 the cash used in the financing activities of $4,000 was due to auto loan payment and repayment of EIDL loan of $3,000.
For the year ended June 30, 2021 the cash used in the financing activities of $4,000 was due to auto loan payment.
Debt Financing
On June
29, 2018the Company entered a business loan agreement with TD bank receiving a line of credit evidenced by a promissory note of $250,000. The interest is subject to change based on changes in an independent index which the Wall Street Journal Prime. The index rate at the date of the agreement is 5.000% per annum. Interest on the unpaid principal balance of the note will be calculated using a rate of 0.740 percentage points over the index, adjusted if necessary for any minimum and maximum rate limitations, resulting in an initial rate of 5.740% per annum based on a year of 360 days. The interest rate was 5% as of June 30, 2022. The Company is required to hold $250,000 in a TD bank savings account as collateral.
As
of June 30, 2022 and June 30, 2021, the line of credit balance was $201,575 with TD bank. The line of credit interest expense was $10,000 and $10,000 for the years ended June 30, 2022 and 2021, respectively.
COVID-19 Relief Loans and Liabilities
Payroll Protection Program ("PPP")
On April 27, 2020, the
Company entered into a PPP loan for $500,000 in connection with the CARES Act related to COVID-19. The promissory note had a fixed payment schedule. The full amount of the PPP loan and accrued interest were forgiven on August 13, 2021 and reported as other income during the year ended June 30, 2022.
Economic Injury Disaster Loan ("EIDL")
EIDL is designed to provide economic relief to businesses that are currently experiencing a temporary loss of revenue due to the Coronavirus (COVID-19) pandemic. EIDL proceeds can be used to cover a wide array of working capital and normal operating expenses, such as continuation to health care benefits, rent, utilities, and fixed debt payments. The
Company received $150,000 EIDL loan. The annual interest rate is 3.75%, the payment term is 30 years and the monthly payment of $731 started on July 1st, 2021. The EIDL loan is secured by the tangible and intangible personal property of the Company. The Company submitted an EIDL loan increase application on May 6, 2022, increasing the loan amount from $150,000 to $200,000. The loan modification was not approved as the funding was exhausted.
Employer Payroll Tax Withholding
The CARES Act allows employers to defer the deposit and payment of the employer share of Social Security tax that
would otherwise be due on or after March 27, 2020, and before January 1, 2021. The Company has deferred approximately $82,000 of the social security tax as of June 30, 2021. 50% of the deferred employment taxes was paid before December 31, 2021. The remaining 50% is not due until December 31, 2022. Approximately $41,000 was reported as short-term other liabilities as of June 30, 2022 and is to paid by December 31, 2022.
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Preferred
stock
On February 14, 2018, the Company entered into a Debt Exchange Agreement (the “Exchange Agreement”) with Mr. DePiano, Sr, the Company's former Chairman and DP Associates Inc. Profit-Sharing Plan of which Mr. DePiano, Sr. is the sole owner and sole trustee (the “Holders”). Pursuant to the terms of the Exchange Agreement, effective February 15, 2018, the Holders exchanged a total of $645,000 principal amount of debt related to the accounts receivable factoring program the Company owes the Holders for 2,000,000 shares
of Series A Convertible Preferred Stock (the “Preferred Stock”). As of June 30, 2022 and June 30, 2021 the cumulative dividends payable is $225,731 ($0.1129 per share) and $174,131 ($0.0871 per share), respectively.
Mr. DePiano Sr. passed away on October 3, 2019 and left a will by which he appointed Richard J. DePiano, Jr., the Chief Executive Officer of the Company, as executor. Richard DePiano Jr. was elected to serve as chairman of the
Company's board. Mr. DePiano, Jr. qualified as executor and has control over the listed shares in his capacity as executor of Mr. DePiano Sr.'s estate.
Common Stock
The Company’s common stock has been quoted on the OTCQB Market since November 18, 2016. The OTCQB Venture Market requires companies be current in their reporting and must undergo an annual verification and management certification process. Companies must also meet a minimum ($0.01) bid test and may not be in bankruptcy.
Other
The
Company’s forecast of the period of time through which its financial resources will be adequate to support its operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed in “Risk Factors” included in this Form 10-K . If the Company raises funds in the future, the Company may be required to raise those funds through public or private financings, strategic relationships or other arrangements at prices and other terms that may not be as favorable as they would without such qualification. The sale of additional equity and debt securities may result in additional dilution to the Company’s shareholders.
Additional financing may not be available in amounts or on terms acceptable to the Company or at all.
Off-balance Sheet Arrangements and Contractual Obligations
The Company was not a party to any off-balance sheet arrangements during the years ended June 30, 2022 and 2021.
Critical Accounting Estimates and policies
The
preparation of financial statements requires management to make estimates and assumptions that impact amounts reported therein. The consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States of America, and, as such, include amounts based on informed estimates and judgments of management.
The following items require significant estimation or judgment:
uncollectible receivables,
obsolete inventory,
Actual results achieved in the future could differ from current estimates. The Company used what it believes are reasonable assumptions and, where applicable, established valuation techniques in making its estimates.
Intangible
Assets and Long-Lived Assets
Long-lived assets including intangible assets deemed to have finite lives, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Impairment indicators include, among other conditions, cash flow deficits, historic or anticipated declines in revenue or operating profit or material adverse changes in the business climate that indicate that the carrying amount of an asset may be impaired. When impairment indicators are present, the recoverability of the asset is measured by comparing the carrying value of the asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the projected undiscounted cash flows from the asset are less than the carrying value of the asset the asset is considered to be impaired. The impairment to be recognized is measured by the amount by which the
carrying amount of the asset exceeds the fair value of the asset. There was no impairment of the long-lived assets, including the ROU assets in the year ended June 30, 2022 and 2021.
20
Revenue Recognition
The Company recognizes revenue when its performance obligations with its customers have been satisfied. At contract
inception, the Company determines if the contract is within the scope of Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers, and then evaluates the contract using the following five steps: (1) identify the contract with the customer; (2) identify the performance obligations; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. The
Company only recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period.
Inventories
Inventories are stated at the lower of cost or net realizable value. Cost is determined on a first-in, first-out basis and include freight-in materials, labor and overhead costs. Inventories are written down if the estimated net realizable value is less than the recorded value. The Company reviews the carrying cost of inventories by product to determine the adequacy of reserves for obsolescence. In accounting for inventories,
the Company must make estimates regarding the estimated realizable value of inventory. The estimate is based, in part, on the Company’s forecasts of future sales and age of inventory. If actual conditions are less favorable than those the Company has projected, the Company may need to increase its reserves for excess and obsolete inventories. Any increases in the reserves will adversely impact the Company’s results of operations. The establishment of a reserve for excess and obsolete inventory establishes a new cost basis in the inventory. Such reserves
are not reduced until the product is sold. If the Company is able to sell such inventory any related reserves would be reversed in the period of sale. In accordance with industry practice, service parts inventory is included in current assets, although service parts are carried for established requirements during the serviceable lives of the products and, therefore, not all parts are expected to be sold within one year.
Income Taxes
The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future
tax consequences of events that have been included in the financial statements. Under this method, the Company determines deferred tax assets and liabilities on the basis of the differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date.
The Company recognizes deferred tax assets to the extent that it believes that these assets are more likely than not to be realized. In making such a determination, the Company
considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If the Company determines that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. As of June 30, 2022 and 2021, the Company has a fully recorded valuation allowance against its deferred tax assets.
The
Company records uncertain tax positions in accordance with ASC 740 on the basis of a two-step process in which (1) the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority.
The Company recognizes interest and penalties related to unrecognized tax benefits on the income tax expense line in the accompanying consolidated statements
of operations. As of June 30, 2022 and 2021, no accrued interest or penalties were required to be included on the related tax liability line in the consolidated balance sheets.
The Company dissolved Escalon Holdings, Inc. and Escalon IP Holdings, Inc. in a tax-free dissolution under Section 332 of the Internal Revenue Code during the year ended June 30, 2021. There is no tax impact on the consolidated financial statements of the Company's current and prior years.
Leases
The
Company determines if an arrangement is a lease at the inception of a contract. Operating lease right-of-use ("ROU") assets are included in right-of-use assets on the consolidated balance sheets. The current and long-term components of
21
operating lease liabilities are included in the current portion of operating lease liabilities and operating lease liabilities, net of current portion, respectively on the consolidated balance sheets.
Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term.
As most of the Company's leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. Certain leases may include options to extend or terminate the lease. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.
Earnings (loss) Per Share
Earnings (loss) per share is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the year. All outstanding
stock options are considered potential common stock. All outstanding convertible preferred stock are considered common stock at the beginning of the period or at the time of issuance, if later, pursuant to the if-converted method. The dilutive effect, if any, of stock options is calculated using the treasury stock method. As of June 30, 2022 and 2021, the average market prices for the years then ended are less than the exercise price of all the outstanding stock options and, therefore, the inclusion of the stock options would be anti-dilutive. In addition, since the effect of common stock equivalents is anti-dilutive with respect to losses, the convertible preferred stock has also been excluded from the Company’s computation of loss per common for the year ended June
30, 2021. Therefore, basic and diluted loss per common share for the year ended June 30, 2021 are the same.
Recently Issued Accounting Standards
The Company considers the applicability and impact of all accounting standards updates ("ASUs"). Management periodically reviews new accounting standards that are issued.
New Accounting Pronouncements Not yet Adopted
In June 2016 the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,
which adds a new Topic 326 to the Codification and removes the thresholds that companies apply to measure credit losses on financial instruments measured at amortized cost, such as loans, receivables, and held-to-maturity debt securities. The guidance in ASU 2016-13 is effective for “public business entities,” as defined, that are SEC filers for fiscal years and for interim periods with those fiscal years beginning after December 15, 2022. Early adoption of the guidance is permitted for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The adoption of this standard is not expected to have a material impact on the Company’s consolidated financial statements.
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of Escalon Medical Corp.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Escalon Medical Corp. and its subsidiaries (the “Company”) as of June 30, 2022 and 2021, and the related consolidated statements of operations, shareholders’ equity, and cash flows for the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements
present fairly, in all material respects, the financial position of the Company as of June 30, 2022 and 2021, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States of America.
The Company’s Ability to Continue as a Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed
in Note 2 to the financial statements, the Company’s significant accumulated deficit and recurring losses from operations and negative cash flows from operating activities in the current year and prior years raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2 to the financial statements. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the
Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or
fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial
statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by
communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Inventory Valuation
Description of the Matter
At June 30, 2022, the Company’s net inventory balance was approximately $1.6 million. As discussed in Note 3 of the financial statements, the Company adjusts the inventory carrying value at the lower of cost or the net realizable value, which includes an estimate of the allowance for obsolescence.
24
How
We Addressed the Matter in Our Audit
Our audit procedures related to management’s judgments underlying the calculation of the allowance for obsolete inventory, including the following, among others:
a.We evaluated the appropriateness and consistency of management’s methods and assumptions used in developing the Company’s estimate of the allowance for obsolete inventory.
b.We evaluated the appropriateness of specific inputs supporting management’s estimate.
c.We tested the mathematical accuracy of the Company’s calculation
of the allowance for obsolete inventory.
Allowance for Doubtful Accounts
Description of the Matter
At June 30, 2022, the Company’s accounts receivable balance, net of an allowance for doubtful accounts of approximately $236,000, was approximately $1.5 million. As discussed in Note 3 of the financial statements, the Company maintains the allowance for potential credit losses based on the Company’s historical trends, specific customer
issues and current economic trends. Accounts are written off against the allowance when they are determined to be uncollectible based on management’s assessment of individual accounts.
How We Addressed the Matter in Our Audit
Our audit procedures related to management’s judgments underlying the calculation of the allowance for doubtful accounts, including the following, among others:
a.We evaluated the appropriateness and consistency of management’s methods and assumptions used in developing the Company’s estimate of the allowance for doubtful accounts.
b.We tested
the mathematical accuracy of the Company’s calculation of the allowance for doubtful accounts.
c.We evaluated the impact of subsequent collections on the outstanding accounts receivable balance as of June 30, 2022.
d.We evaluated the risk of collectability based on graphical location.
Operating
lease liabilities, net of current portion
i538,794
i630,330
EIDL
loan, net of current portion
i149,540
i147,138
Other
long-term liabilities
i—
i40,860
Total
long-term liabilities
i692,222
i826,167
Total
liabilities
i3,694,220
i4,222,930
Commitments
and Contingencies (Note 10.)
Shareholders' equity:
Series A convertible preferred stock, $0.001 par value; 2,000,000 shares authorized; 2,000,000 shares issued and outstanding (liquidation value of $870,731 and $819,131)
i645,000
i645,000
Common
stock, $0.001 par value; 35,000,000 shares authorized; 7,415,329 shares issued and outstanding
i7,415
i7,415
Additional
paid-in capital
i69,702,043
i69,702,043
Accumulated
deficit
(i68,876,441)
(i68,894,522)
Total
shareholders’ equity
i1,478,017
i1,459,936
Total
liabilities and shareholders’ equity
$
i5,172,237
$
i5,682,866
See
notes to consolidated financial statements
26
ESCALON MEDICAL CORP. AND SUBSIDIARIES CONSOLIDATED
STATEMENTS OF OPERATIONS
iEscalon
Medical Corp. ("Escalon" or "Company") is a Pennsylvania corporation initially incorporated in California in 1987, and reincorporated in Pennsylvania in November 2001. Within this document, the “Company” collectively shall mean Escalon, which includes its division called "Trek" and its wholly owned subsidiaries: Sonomed, Inc. (“Sonomed”), Escalon Digital Solutions, Inc. (“EMI”), and Sonomed IP Holdings, Inc. The Company dissolved two other inactive entities, Escalon Holdings, Inc. and Escalon IP Holdings, Inc. in a tax-free dissolution under Section 332 of the Internal Revenue Code in the year ended June 30, 2021.
The
Company operates in the healthcare market, specializing in the development, manufacture, marketing and distribution of medical devices and pharmaceuticals in the area of ophthalmology. The Company and its products are subject to regulation and inspection by the United States Food and Drug Administration (the “FDA”). The FDA and other government authorities require extensive testing of new products prior to sale and have jurisdiction over the safety, efficacy and manufacture of products, as well as product labeling and marketing.
On March 11, 2020, the World Health Organization declared the outbreak of a coronavirus (COVID-19) a pandemic. This pandemic has had a significant impact on the global and domestic economy, and has and is
likely to continue to impact the operations of the Company. The Company has been assessing the impact of the COVID-19 pandemic on the business, including the impact on the financial condition and results of operations, financial resources, changes in accounting judgment as well as the impact on the supply and demand, etc. The Company is considered an essential business and has been able to maintain operations during the lockdown. The Company applied for and received $i500,000
in April 2020 under the Payroll Protection Program ("PPP loan") which will help reverse the negative impact in terms of the liquidity. The Company submitted the loan forgiveness application on August 2, 2021. The PPP loan forgiveness was approved and the full amount and accrued interest was forgiven on August 13, 2021. The Company also received Economic Injury Disaster loan ("EIDL") loan of $150,000. The annual interest rate is 3.75%. The payment term is 30 years and the monthly payment is $731 from July 1, 2021. The Company was spared from the government
shutdown during the pandemic. The supply chain challenges could increase the costs of products and numbers of backorders and could adversely affect our results of operations. In February 2022, Russia invaded Ukraine. As military activity proceeds and sanctions, export controls and other measures are imposed by many countries against Russia, Belarus and specific areas of Ukraine, the war is increasingly affecting the global economy and financial markets, as well as exacerbating ongoing economic challenges, including rising inflation and global supply-chain disruption. The Company has operations or activities in countries and regions outside the United States. As a result, its global operations are affected by economic, political and other conditions in the foreign countries in which the Company has business
as well as U.S. laws regulating international trade, although the Company has not yet assessed that the war has had a material effect on its financial position or results of operations. The Company will continue to monitor the impacts of the Russia-Ukraine war on macroeconomic conditions and continually assess the effect these matters may have on customer demand, suppliers’ ability to deliver products, cybersecurity risks and its liquidity and access to capital.
The Company’s common stock trades on the OTCQB Market under the symbol “ESMC.”
2i.
Going Concern
The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the continuous enhancement of the current products, development of new products; changes in domestic and foreign regulations; ability of manufacture successfully; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, the Company’s products and its ability to raise capital to support its operations.
To date, the
Company’s operations have not generated sufficient revenues to enable profitability. As of June 30, 2022, the Company had an accumulated deficient of $i68.9 million, and incurred recurring losses from operations and incurred negative cash flows from operating activities in current and prior years. These factors raise substantial doubt regarding the
Company’s ability to continue as a going concern for the following twelve months as of the filing date of this form 10-K.
The accompanying consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. These consolidated
31
financial statements do not include any adjustments relating to the realization of the carrying value of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
The
Company's continuance as a going concern is dependent on its future profitability and on the on-going support of its shareholders, affiliates and creditors. In order to mitigate the going concern issues, the Company is actively pursuing business partnerships, managing its continuing operations, implementing cost-cutting measures and seeking to sell certain assets. The Company may not be successful in any of these efforts.
3. iSummary
of Significant Accounting Policies
Principles of Consolidation
iThe consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated.
Use of Estimates
iThe
preparation of financial statements in conformity with accounting principles generally affected in the United States of America Generally Accepted Accounting Principles ("US GAAP") requires management to make estimates and assumptions that impact the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.
Cash and Cash Equivalents
iFor
the purposes of reporting cash flows, the Company considers all cash accounts, which are not subject to withdrawal restrictions or penalties, and highly liquid investments with original maturities of i90 days or less to be cash and cash equivalents. From time to time cash balances exceed federal insurance limits./
Restricted Cash
iAs
of June 30, 2022 and 2021 restricted cash included approximately $i256,000, which was pursuant to the requirements in the TD Bank Loan entered into June 2018 (see Note 6)./
Foreign Currency Translation
iThe
Company's functional currency is the US dollar. Transaction gains and losses that arise from exchange rate fluctuations on transactions denominated in a currency other than the functional currency are included in the results of operations as incurred. Foreign currency transaction gains or losses included in net loss were immaterial for the years ended June 30, 2022 and 2021.
Accounts Receivable
i
Accounts
receivable are recorded at net realizable value. The Company performs ongoing credit evaluations of customers’ financial condition and does not require collateral for accounts receivable arising in the normal course of business. The Company maintains allowances for potential credit losses based on the Company’s historical trends, specific customer issues and current economic trends. Accounts are written off against the allowance when they are determined to be uncollectible based on management’s assessment of individual accounts. The Company recorded an allowance for doubtful accounts of approximately $i236,000
and $i100,000 as of June 30, 2022 and 2021.
Inventories
are stated at the lower of cost or net realizable value. Cost is determined on a first-in, first-out basis and include freight-in materials, labor and overhead costs. Inventories are written down if the estimated net realizable value is less than the recorded value. The Company reviews the carrying cost of inventories by product to determine the adequacy of reserves for obsolescence. In accounting for inventories, the Company must make estimates regarding the estimated realizable value of inventory. The estimate is based, in part, on the Company’s forecasts of future sales and age of inventory. If actual conditions are less favorable than those the
Company has projected, the Company may need to increase its reserves for excess and obsolete inventories. Any increases in the reserves will adversely impact the Company’s results of operations. The establishment of a reserve for excess and obsolete inventory establishes a new cost basis in the inventory. Such reserves are not reduced until the product is sold. If the Company is able to sell such inventory any related reserves would be reversed in the period of sale. In accordance with industry practice, service parts inventory is included in current assets, although service parts are carried for established requirements during the serviceable lives of the products and, therefore, not all parts are expected to be
sold within one year.
iProperty and equipment are recorded at cost. Leasehold improvements are amortized on a straight-line basis over the lesser of the estimated useful life of the asset or lease term. Depreciation on property and equipment is recorded using the straight-line method over the estimated economic useful life of the related assets. Estimated useful lives are generally three years to five years for computer equipment and software, five years to seven years for furniture and fixtures and five years to ten
years for production and test equipment. Depreciation and amortization expense for the years ended June 30, 2022 and 2021 was approximately $29,000 and $25,000, respectively.
iLong-lived assets including intangible assets deemed to have finite lives, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Impairment indicators include, among other conditions, cash flow deficits, historic or anticipated declines in revenue or operating profit or material adverse changes in the business climate that indicate that the carrying amount of an asset may be impaired. When impairment indicators
are present, the recoverability of the asset is measured by comparing the carrying value of the asset to the estimated undiscounted future cash flows expected to be generated by the asset. If the projected undiscounted cash flows from the asset are less than the carrying value of the asset the asset is considered to be impaired. The impairment to be recognized is measured
33
by the amount by which the carrying amount of the asset exceeds the fair value of the asset. There was no impairment of the long-lived assets, including the ROU assets in the year ended June 30, 2022 and 2021.
Accrued
Warranties
iThe Company provides a limited one-year warranty against manufacturer’s defects on its products sold to customers. The Company’s standard warranties require the Company to repair or replace, at the Company’s discretion, defective parts during such warranty period.
The Company accrues for its product warranty liabilities based on estimates of costs to be incurred during the warranty period, based on historical repair information for warranty costs.
PPP Loans
iThe Company's policy is to account for the PPP loan(See Note 7)as debt. The Company continued to record the loan as debt until either (1) the loan is partially or entirely forgiven and the Company has been legally released, at which point the amount forgiven will be recorded as income or (2) the Company pays off the loan.The full amount of the PPP loan and accrued interest were forgiven on August 13, 2021 and reported as other income during the year ended June 30, 2022.
Fair Value of Financial Instruments
iThe
carrying amounts for cash and cash equivalents, restricted cash, accounts receivable, accounts payable and accrued liabilities approximate their fair value because of their short-term maturity. The Company determined that the carrying amount of the notes payable and lease liabilities approximates fair value since such debt borrowing bears interest at the approximate current market rate. While the Company believes the carrying value of the assets and liabilities are reasonable, considerable judgment is used to develop estimates of fair value; thus the estimates are not necessarily indicative of the amounts that could be realized in a current market exchange.
Revenue Recognition
iThe
Company recognizes revenue when its performance obligations with its customers have been satisfied. At contract inception, the Company determines if the contract is within the scope of Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers, and then evaluates the contract using the following five steps: (1) identify the contract with the customer; (2) identify the performance obligations; (3)
determine the transaction price; (4) allocate the transaction price to the performance obligations; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only recognizes revenue to the extent that it is probable that a significant revenue reversal will not occur in a future period.
The Company generates product revenue from the sale of medical device products and the sale and installation of the Company's AXIS image management system software. Revenue for service plans relate to the customer care plans for the
Company’s equipment and AXIS image management system software.
Revenue is recognized upon transfer of control of the promised goods or services to the customer for an amount that reflects the consideration that the Company expects to be entitled in exchange for those goods or services. The Company’s performance obligations are for product sales, installation of AXIS image management system software and customer care plans. The performance obligations are determined at contract inception based upon promises within the contract that
are distinct.
The product sales and installation of AXIS image management system software performance obligations are satisfied at a point in time, which is upon shipment for product sales and upon successful installation for the AXIS image management system. The performance obligation for customer care plans is satisfied over time as the customer receives and consumes the Company’s services.
The Company invoices its customers upon shipment for product sales. For the installation of AXIS image management system software and customer care plans, the Company
invoices its customers upon successful installation. Invoice payments are generally due within 30 days of invoice date. The transaction price is determined based on fixed consideration in the Company’s customer contracts and is recorded net of variable consideration. In determining the transaction price, a significant financing component does not exist since the timing from when the Company invoices its customers to when payment is received as it is less than one year.
34
Revenue
for product sales and installation of AXIS image management system software is recognized when delivered or installed. The customer care plan revenues are recognized proportionately over the service period, which is a 12-month period.
The Company has elected the following practical expedients in applying ASC 606:
•Unsatisfied Performance Obligations - all performance obligations relate to contracts with a duration of less than one year, the Company has elected to apply the optional exemption provided in ASC 606 and therefore, is not required to disclose the aggregate amount of the transaction
price allocated to performance obligations that are unsatisfied or partially unsatisfied at the end of the reporting period.
•Contract Costs - all incremental customer contract acquisition costs are expensed as they are incurred as the amortization period of the asset that the Company otherwise would have recognized is one year or less in duration.
•Significant Financing Component - the Company does not adjust the promised amount of consideration for the effects of a significant financing
component as the Company expects, at contract inception, that the period between when the entity transfers a promised good or service to a customer and when the customer pays for that good or service will be one year or less.
•Sales Tax Exclusion from the Transaction Price - the Company excludes from the measurement of the transaction price all taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction and collected by the Company from the customer.
•Shipping
and Handling Activities - the Company elected to account for shipping and handling activities as a fulfillment cost rather than as a separate performance obligation.
•Portfolio Approach - the Company applied the Portfolio Approach to contract reviews within its identified revenue streams that have similar characteristics and the Company believes this approach would not differ materially than if applying Topic 606 to each individual contract.
Deferred
Revenue
The Company records deferred revenues when cash payments are received or due in advance of its performance. The Company’s deferred revenues relate to payments received for the customer care plans for a 12-month period. The consideration received is recognized monthly over the service period.
Included
in accrued expenses as of June 30, 2022 is approximately $i213,000 of customer deposits that will be recorded as income in the consecutive period once the products have been shipped.
Shipping and Handling Revenues and Costs
iShipping
and handling revenues are included in product revenue and the related costs are included in cost of goods sold.
Research and Development
iAll research and development costs are charged to operations as incurred.
Advertising Costs
iAdvertising
costs are charged to operations as incurred. Advertising expense for the years ended June 30, 2022 and 2021 was $0 and $i4,000. The Company had in-house marketing activities during the year ended June 30, 2022 and 2021./
Earnings (Loss) Per Share
35
i
Earnings (lioss)
per share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding during the year. All outstanding stock options are considered potential common stock. All outstanding convertible preferred stock are considered common stock at the beginning of the period or at the time of issuance, if later, pursuant to the if-converted method. The dilutive effect, if any, of stock options is calculated using the treasury stock method. As of June 30, 2022 and 2021, the average market prices for the years then ended are less than the exercise price of all the outstanding stock options and, therefore, the inclusion of the stock options would be anti-dilutive. In addition, since the effect of common stock equivalents is anti-dilutive with respect to losses, the convertible preferred stock has also been excluded from the
Company’s computation of loss per common for the year ended June 30,2021. Therefore, basic and diluted loss per common share for the year ended June 30, 2021 are the same.
Total
potential dilutive securities not included in income per share
i157,000
i5,617,873
Income
Taxes
iThe Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, the Company determines deferred tax assets and liabilities on
the basis of the differences between the financial statement and tax bases of assets and liabilities by using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date.
The Company recognizes deferred tax assets to the extent that it believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results
of recent operations. If the Company determines that it would be able to realize its deferred tax assets in the future in excess of their net recorded amount, the Company would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. As of June 30, 2022 and June 30, 2021, the Company has recorded a full valuation allowance against its deferred tax assets.
The Company records uncertain tax positions
in accordance with ASC 740 on the basis of a two-step process in which (1) the Company determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, the Company recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority.
The Company recognizes interest and penalties related to unrecognized tax benefits on the income tax expense line in the accompanying consolidated statements
of operations. As of June 30, 2022 and June 30, 2021, no accrued interest or penalties were required to be included on the related tax liability line in the consolidated balance sheets. The Company dissolved Escalon Holdings, Inc. and Escalon IP Holdings, Inc. in a tax-free dissolution under Section 332 of the Internal Revenue Code during the year ended June 30, 2021. There is no tax impact on the consolidated financial statements of the Company's current and prior years.
Leases
iThe
Company determines if an arrangement is a lease at the inception of a contract. Operating lease right-of-use ("ROU") assets are included in right-of-use assets on the consolidated balance sheets. The current and long-term components of operating lease liabilities are included in the current portion of operating lease liabilities and operating lease liabilities, net of current portion, respectively on the consolidated balance sheets.
Operating lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term. As most of the Company's leases do not provide an implicit rate, the
Company uses an incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. Certain leases may include options to extend or terminate the lease. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.
New Accounting Pronouncements
Recently Issued Accounting Standards
38
The Company considers the applicability and impact of all accounting standards updates ("ASUs"). Management periodically reviews new accounting standards that
are issued.
New Accounting Pronouncements Not yet Adopted
In June 2016 the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which adds a new Topic 326 to the Codification and removes the thresholds that companies apply to measure credit losses on financial instruments measured at amortized cost, such as loans, receivables, and held-to-maturity debt securities. The guidance in ASU 2016-13 is effective for “public business entities,” as defined, that are SEC filers for fiscal years and for interim periods with those fiscal years beginning after December 15, 2022. Early adoption of the guidance is permitted for fiscal years beginning after December 15, 2018,
including interim periods within those fiscal years. The adoption of this standard is not expected to have a material impact to the Company’s consolidated financial statements.
4. iIntangible Assets
The
Company's intangible assets consist of the following:
Licenses
The Company purchased no new licenses for year end June 30, 2022 and 2021, respectively and the cost is capitalized and amortized over i10 years. Amortization expense is approximately $i20,000
for each of the years ended June 30, 2022 and 2021. Annual amortization related entirely to licenses is estimated to be $i19,650 for the years ending June 30, 2023 through 2026 and $i4,150
thereafter.
The following table presents amortized licenses as of June 30, 2022:
i
i
Gross Carrying Amount
Impairment
Adjusted Gross Carrying Amount
Accumulated Amortization
Net Carrying Value
Amortized
Intangible Assets Licenses
$
i199,000
$
i—
$
i199,000
$
(i116,250)
$
i82,750
Total
$
i199,000
$
i—
$
i199,000
$
(i116,250)
$
i82,750
/
The
following table presents amortized licenses as of June 30, 2021:
Accrued
compensation as of June 30, 2022 and 2021 primarily relates to payroll, vacation accruals, and payroll tax liabilities.
/
6. Line of Credit
iOn
June 29, 2018the Company entered a business loan agreement with TD bank receiving a line of credit evidenced by a promissory note of $i250,000. The interest is subject to change based on changes in an independent index which the Wall Street Journal Prime. The index rate at the date of the agreement is i5.000%
per annum. Interest on the unpaid principal balance of the note is calculated using a rate of i0.740 percentage points over the index, adjusted if necessary for any minimum and maximum rate limitations, resulting in an initial rate of i5.740%
per annum based on a year of 360 days. The interest rate was i5% as of June 30, 2022. The Company was required to put $i250,000
in the TD bank savings account as collateral. Mr. Richard J. DePiano Sr. executed a guarantee of the loan in favor of TD Bank. Mr. DePiano Sr. passed away on October 3, 2019, therefore the guarantee is now assumed by his estate. /
As of June 30, 2022 and 2011, the line of credit balance was $i201,575
with TD bank. The line of credit interest expense was approximately $i10,000 and $i10,000
for the years ended June 30, 2022 and 2021, respectively.
7. iLong-term debt
Paycheck Protection Program ("PPP") loan
On April
27, 2020, the Company entered into a PPP loan for $i500,000 in connection with the CARES Act related to COVID-19. The full amount of the PPP loan was classified as current as of June 30, 2021.The full amount of the PPP loan and accrued interest were forgiven on August 13, 2021 and reported as other income during the year ended June
30, 2022.
Economic Injury Disaster ("EIDL") loan
EIDL is designed to provide economic relief to businesses that are currently experiencing a temporary loss of revenue due to the Coronavirus (COVID-19) pandemic. EIDL proceeds can be used to cover a wide array of working capital and normal operating expenses, such as continuation to health care benefits, rent, utilities, and fixed debt payments. The Company received $150,000 EIDL loan. The annual interest rate is 3.75%. The payment term is 30 years and the monthly payment is $731 from July 1, 2021. The EIDL loan is secured by the tangible and intangible personal property of the
Company. The Company submitted an EIDL loan increase application on May 6, 2022, increasing the loan amount from $150,000 to $200,000. The loan modification was not approved as the funding was exhausted
The future annual principal amounts and accrued interest to be paid as of June 30, 2022 are as follows:
40
i
Year
ending June 30,
EIDL Loan Payment
2023
$
i3,105
2024
i3,084
2025
i3,202
2026
i3,324
2027
i3,582
Thereafter
i136,348
Total
$
i152,645
/
Other
Short-term and Long-term Liabilities
The CARES Act allows employers to defer the deposit and payment of the employer share of Social Security tax that would otherwise be due on or after March 27, 2020, and before January 1, 2021. The Company has deferred approximately $i82,000 of the social security tax as of June
30, 2021. 50% of the deferred employment taxes was paid before December 31, 2021. The remaining 50% is not due until December 31, 2022. Approximately $41,000 of the employer payroll tax withholding deferral was reported as short-term other liabilities as of June 30, 2022.
8. Capital Stock Transactions
i
Stock
Option Plans
As of June 30, 2022, the Company had in effect itwo employee stock option plans that provide for incentive and non-qualified stock options. Under the terms of the plans, options may not be granted for less than the fair market value of the Common Stock at the date of grant. Vesting generally
occurs ratably between one and five years and for non-employee directors, immediately, and the options are exercisable over a period no longer than i10 years after the grant date. As of June 30, 2022, options to purchase i157,000
shares of the Company’s common stock were outstanding, of which i157,000 were exercisable, and i0
shares were unvested.
The following is a summary of Escalon’s stock option activity and related information for the fiscal years ended June 30, 2022 and 2021:
2022
2021
Common Stock Options
Weighted Average Exercise Price
Common Stock Options
Weighted Average Exercise Price
Outstanding
at the beginning of the year
i157,000
$
i1.47
i157,000
$
i1.47
Granted
i—
i—
i—
i—
Exercised
i—
i—
i—
i—
Forfeited
i—
i—
i—
$
i—
Outstanding
at the end of the year
i157,000
$
i1.47
i157,000
$
i1.47
Exercisable
at the end of the year
i157,000
$
i1.47
i157,000
i1.47
Weighted
average fair value of options granted during the year
$
—
$
—
The following table summarizes information about stock options outstanding as of June 30, 2022:
There
was iino/
compensation expense related to stock options for the years ended June 30, 2022 and 2021.
9. Income Taxes
ii
The
provision for income taxes for the years ended June 30, 2022 and 2021 consists of the following:
2022
2021
Current income tax provision
Federal
$
—
$
—
State
—
—
—
—
Deferred
income tax provision
Federal
(i82,615)
i51,366
State
(i23,605)
i14,676
Change
in valuation allowance
i106,220
(i66,042)
—
—
Income
tax expense (benefit)
$
—
$
—
Income tax expense (benefit) as a percentage of loss for the years ended June 30, 2022 and 2021 differ from statutory federal income tax rate due to the following:
/
2022
2021
Statutory
federal income tax rate
i21.00
%
i21.00
%
Permanent
differences
i0.00
%
i0.00
%
Valuation
allowance
(i21.00)
%
(i21.00)
%
Effective
income tax rate
i0.00
%
i0.00
%
i
The
components of the net deferred income tax assets and liabilities as of June 30, 2022 and 2021 are as follows:
/
42
2022
2021
Deferred
income tax assets:
Net operating loss carryforward
$
i7,430,299
$
i7,352,719
Executive
post retirement costs
i—
i—
General
business credit
i—
i—
Allowance
for doubtful accounts
i49,633
i21,100
Accrued
vacation
i48,969
i49,336
Inventory
reserve
i73,583
i69,432
Accelerated
depreciation
i57,628
i65,432
Warranty
reserve
i6,736
i6,736
Total
deferred income tax assets
i7,666,848
i7,564,755
Valuation
allowance
(i7,649,471)
(i7,543,251)
i17,377
i21,504
Deferred
income tax liabilities:
Accelerated depreciation
(i17,377)
(i21,504)
Total
deferred income tax liabilities
(i17,377)
(i21,504)
$
i—
$
i—
As
of June 30, 2022, the Company has a valuation allowance of $i7,649,471, which primarily relates to the federal net operating loss carryforwards. During the year ended June 30, 2022, the valuation allowance increased by $i106,220
and during the year ended June 30, 2021, the valuation decreased by $i66,042. The valuation allowance is a result of management evaluating its estimates of the net operating losses available to the Company as they relate to the results of operations of acquired businesses subsequent to their being acquired by the
Company. The Company evaluates a variety of factors in determining the amount of the valuation allowance, including the Company’s earnings history, the number of years the Company’s operating loss can be carried forward, the existence of taxable temporary differences, and near-term earnings expectations. Future reversal of the valuation allowance will be recognized either when the benefit is realized or when it has been determined that it is more likely than not that the benefit will be realized through future earnings. The Company has available federal and state net operating loss carry forwards of approximately $i33,921,000
and $i3,208,000, respectively, of which $i25,147,000 and $i2,785,000,
respectively, will expire over the next ten years, $i6,707,000 and $i423,000, respectively, will expire
in years eleven through twenty, and $i2,067,000 and $i0,
respectively, which will not expire.
The Company continues to monitor the realization of its deferred tax assets based on changes in circumstances, for example, recurring periods of income for tax purposes following historical periods of cumulative losses or changes in tax laws or regulations. The Company’s income tax provision and management’s assessment of the realizability of the Company’s deferred tax assets involve significant judgments and estimates. If taxable income expectations change, in the near term the Company may be required to reduce the valuation allowance which would result
in a material benefit to the Company’s results of operations in the period in which the benefit is determined by the Company.
Fiscal year ended June 30, 2019 and subsequent years remain open to tax examination. However, to the extent allowed by law, the tax authorities may have the right to examine prior periods where net operating losses were generated and carried forward, and make adjustments up to the amount of the net operating loss amount. At June 30, 2022, the Company did not have any significant unrecognized
tax positions. The Company has provided what it believes to be an appropriate amount of tax for items that involve interpretation to the tax law. However, events may occur in the future that will cause the Company to reevaluate the current provision and may result in an adjustment to the liability for taxes.
10. Commitments and Contingencies
i
Legal
Proceedings
The Company, from time to time is involved in various legal proceedings and disputes that arise in the normal course of business. These matters have included intellectual property disputes, contract disputes, employment disputes and other matters. The Company does not believe that the resolution of any of these matters has had or is likely to have a material adverse impact on the Company’s business, financial condition or results of operations.
43
11. iRelated
Party Transactions and Preferred Stock
On February 14, 2018, the Company entered into a Debt Exchange Agreement (the “Exchange Agreement”) with Mr. DePiano Sr., the Company's former Chairman and DP Associates Inc. Profit-Sharing Plan of which Mr. DePiano Sr. is the sole owner and sole trustee (the “Holders”). Pursuant to the terms of the Exchange Agreement, effective February 15, 2018, the Holders exchanged a total of $i645,000
principal amount of debt related to the accounts receivable factoring program for i2,000,000 shares of Series A Convertible Preferred Stock (the “Preferred Stock”).
Each share of Preferred Stock entitles the Holder thereof to 13 votes per share and will vote together with all other classes and series of stock of the Company as a single class on all actions to be taken by the
Company’s stockholders. As a result of this voting power, the Holders as of June 30, 2022 beneficially own approximately i77.81% of the voting power on all actions to be taken by the Company’s shareholders.
Subject to the terms and conditions of Preferred Stock, the holder of any share or shares of the Preferred Stock has the right, at its option at any time, to convert each such share of Preferred Stock (except that, upon any liquidation of the
Company, the right of conversion will terminate at the close of business on the business day fixed for payment of the amounts distributable on the Preferred Stock) into i2.15 shares of Common Stock (the “Conversion Ratio”). The Conversion Ratio is subject to standard provisions for adjustment in the event of a subdivision or combination of the Company’s Common Stock and upon any reorganization or reclassification of the capital stock of the
Company. If the Holders were to convert their shares of Preferred Stock into Common Stock at the Conversion Ratio the Holders would receive a total of i4,300,000 shares of Common Stock, or approximately i36.70%
of the then outstanding shares of Common Stock assuming such conversion.
Each outstanding share of the Preferred Stock accrues dividends calculated cumulatively at the annual rate of $i.0258 per share (such amount subject to equitable adjustment in the event of any stock dividend, stock split, combination, reclassification other similar event), payable upon the earlier of (i) a liquidation, dissolution or winding up of the Company
or (ii) conversion of the Preferred Stock into Common Stock. Upon either of such events, all such accrued and unpaid dividends, whether or not earned or declared, to and until the date of such event, will become immediately due and payable and will be paid in full. The dividends payable to the holders of the Preferred Stock is payable in cash or, at the election of any such holder, in a number of additional shares of Common Stock equal to the amount of the dividend expressed in dollars divided by the then applicable Conversion Ratio, described above. As of June 30, 2022 and 2021 the cumulative dividends payable is $i225,731
($i0.1129 per share) and $i174,131 ($i0.0871
per share), respectively.
Mr. DePiano Sr. passed away on October 3, 2019 and left a will by which he appointed Richard J. DePiano, Jr., the Chief Executive Officer of the Company, as executor. Richard DePiano Jr. was elected to serve as chairman of the Company's board. Mr. DePiano, Jr. qualified as executor and has control over the listed shares in his capacity as executor of Mr. DePiano Sr.'s estate.
12. iConcentration
of Credit Risk
Credit Risk
Financial Instruments, which potentially subject the Company to concentration of credit risk, consist principally of cash and cash equivalents, restricted cash and trade receivables. Concentration of credit risk with respect to trade receivables is generally diversified due to the large number of entities comprising the Company's customer base and their dispersion across geographic areas principally within the United States and international. The Company routinely address the financial strength of its customer and, as a consequence, believes that its
receivable credit risk exposure is limited. The Company does not require customers to post collateral.
Major Customer
iOne customer accounted for approximately i11%
of net sales during the year ended June 30, 2022. iOne customer accounted for approximately i15% of net sales during the year ended June 30, 2021.
As
of June 30, 2022the Company had ione customer that represents approximately i13% of the total accounts receivable balance. As of June
30, 2021the Company had ione customer that represents approximately i23% of the total accounts receivable balance.
Major Supplier
44
The
Company's itwo largest suppliers accounted for i39% and i12%
of the total purchases for the year ended June 30, 2022. The Company's itwo largest suppliers accounted for the total purchases for i40% and i10% of
total purchases for the year ended June 30, 2021. As of June 30, 2022the Company had onei supplier that represent approximately i36%
of the total accounts payable balance. As of June 30, 2021the Company had two customer that represents i39% and i12%
of the total accounts payable balance.
Foreign Sales
iDomestic and international sales from continuing operations are as follows:
iThe Company leases certain facilities and equipment under operating leases. Total lease expense, under ASC 842, was included in cost of goods sold and marketing, general and administrative costs in our unaudited condensed consolidated statement of operations for the years ended June 30, 2022 and 2021 as follows:
On
April 28, 2022the Company extended the lease agreement for its Wisconsin warehouse, which will end in April 30, 2022 for a term of three years. The lease agreement has a lease ROU assets and lease liability of approximately $224,000, respectively. The Company classified the amended lease as an operating lease under ASC 842.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING
AND FINANCIAL DISCLOSURE
None
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
As of the end of the period covered by this Annual Report on Form 10-K, the Company’s management
evaluated, with the participation of the Company’s principal executive officer and principal financial officer, the effectiveness of the Company’s disclosure
controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934). Based upon that evaluation, the Company’s principal executive officer and principal financial officer concluded that the Company’s disclosure controls and procedures are not effective in ensuring that information required to be disclosed by the Company in the reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and is accumulated and communicated to our management, including the Company’s principal
executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Management’s Report on Internal Control over Financial Reporting
The Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934). The Company’s internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP and includes those policies and procedures that:
•Pertain
to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the Company’s assets;
46
•Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that the Company’s receipts and expenditures are being made only in accordance with authorizations of the Company’s management and directors; and
•Provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on our financial statements.
As of the end of the period covered by this Annual Report on Form 10-K, the Company’s management evaluated, with the participation of its principal executive officer and principal financial officer, the effectiveness of the Company’s internal control over financial reporting. This evaluation was conducted using the framework in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission 2013. We identified a material weakness
in internal control related to the proper design and implementation of controls over our estimates relating to the valuation of inventory and allowance for doubtful accounts, specifically over the precision of management’s review. Based on our evaluation and as a result of the material weakness identified, our management, with the participation of our principal executive officer and principal financial officer, concluded that our internal control over financial reporting was not effective as of June 30, 2022.
Remediation Plan for Existing Material Weakness
Management is committed to the remediation of the material weakness described above. As such, controls will be added to both increase the precision of the review of all assumptions used in the valuation of inventory and allowance for doubtful accounts, as well as to conduct senior
management reviews of any and all material estimates that are applied in these instances
Pursuant to the rules of the SEC, the Company’s management’s report on internal control over financial reporting is furnished with this Annual Report on Form 10-K and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933 or Securities Exchange Act of 1934.
This Annual Report on Form 10-K does not include an attestation report of the Company’s independent registered public
accounting firm regarding the Company's internal control over financial reporting. The Company’s management’s report on internal control over financial reporting was not subject to attestation by the Company’s independent registered public accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permits the Company to provide only the Company’s management’s report on internal control over financial reporting in this Annual Report on Form 10-K.
Changes in Internal Control
Over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during our fourth fiscal quarter of 2022 that would have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
None
PART III.
ITEM
10 DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Directors and Executive Officers
The following table sets forth information with respect to our directors and our executive officers.
Set forth below are the names, positions held and business
experience, including during the past five years, of our directors and executive officers as of September 27, 2022. Officers serve at the discretion of the board of directors.
Mr. DePiano, Jr. has been a Class I director since May 9, 2013, and was appointed our President and General Counsel of the Company on January 1, 2008 and our Chief Executive Officer on September 28, 2013. Previously, he was Chief Operating Officer and General Counsel. Mr. DePiano, Jr. joined us in November of 2000 as Vice President Corporate and Legal Affairs. He currently serves as a member of the board of directors, and served as President from 2008 to 2009 of the Delaware
Valley Corporate Counsel Association (“DELVACCA”). Mr. DePiano, Jr. also serves as a member of the nominations committee, Chairman of the law school initiative committee and member of the pro-bono committee of DELVACCA. He also is vice chairman of the board of directors of the Montgomery County Industrial Development Authority.
Mr. Wallace was appointed our Chief Operating Officer on January 1, 2008. He was also appointed the Principal Financial and Accounting Officer on July 7, 2017. Mr. Wallace has worked with us since 1997. Previous to being appointed Chief Operating Officer he was Executive Vice President of our Escalon Digital Solutions and Trek Medical subsidiaries. He has jointly held the position of Vice President-Quality,
with quality and regulatory responsibilities for all of our companies, and has also previously served as Operations Manager at Sonomed, Inc. and our Quality Manager. He had previously worked with Lunar Corp. (now GE Healthcare) and Trek Medical. He holds a B.S. in Industrial Engineering and a M.S. in Manufacturing Systems Engineering, both from the University of Wisconsin-Madison, is a senior member of the American Society of Quality, and has over 20 years experience in the medical device industry.
Ms. Napolitano has served on our board of directors since 2003. She is a Class II director. Ms. Napolitano has served as a Tax Manager at Global Tax Management, Inc., a provider of compliance support services for both federal and state taxes, since 1998. Ms. Napolitano is a Certified Public Accountant in Pennsylvania. Ms. Napolitano qualifies for our board of directors and audit committee based on her extensive experience in public
accounting and through her understanding of internal controls, accounting principles, business operations and regulatory compliance. We believe that Ms. Napolotano’s financial, operational and regulatory experience qualifies her to serve as a member of our board of directors and our audit committee.
Mr. Trusk was appointed as a member of our Board in 2015 as a Class I director. He is President of BroadBase Solutions, Inc., an information technology staffing and consulting firm since 2000. Mr. Trusk was a sales executive with CB Technologies an IT consulting firm based in the Philadelphia suburbs. Before joining CB Technologies Mr. Trusk held several sales and sales management positions within the disposable medical equipment markets. B. Braun Medical from 1994 to 1997 and Calgon Vestal Labs, a subsidiary of Merck & Co.; Inc. from 1991 to 1994. We believe Mr. Trusk’s operational,
executive and professional experience qualifies him to serve as a member of our Board and our Audit Committee.
Mr. Jacovini was appointed as a Class III Director in February 2018. He currently serves as the Chief Financial Officer of LaFrance Corp, a global manufacturer specializing in on-product branding. Previously, he was President and Founder of Innovator Management LLC, a sponsor of mutual funds and exchange traded funds, from 2011 to 2017. He served as Chief Executive Officer and portfolio manager of Academy Asset Management LLC from 2007 to 2015. Between 2007 and 2017 he held the positions of President, Treasurer, and Trustee of the Academy Funds Trust, a registered investment company. Prior to that, he worked on Wall Street as a derivatives marketer at Deutsche Bank AG and as a municipal strategist at Prudential Securities Incorporated. He holds a BA from the College of the Holy
Cross and an MBA from the MIT Sloan School of Management. We believe Mr. Jacovini's operational, executive and professional experience qualifies him to serve as a member of our Board and our Audit Committee.
Mr. Dogum was appointed as a Class II director in February 2018. John P. Dogum is a partner at Martin Law where he has been working since 2003. He has concentrated his practice on litigating Pennsylvania workers’ compensation cases since 1992. Mr. Dogum has served as consultant to major insurers in addition to frequently appearing before Workers’ Compensation
48
Judges in the Eastern region of Pennsylvania. Mr.
Dogum has argued a case of first impression before the Third Circuit Court of Appeals. He has also litigated claims under the Federal Longshore and Harbor Workers’ Compensation Act. Mr. Dogum has been listed as a Pennsylvania Super Lawyer since 2009 as well as a Top 100 Philadelphia Super Lawyer in 2009. He has been listed as a Best Lawyer since 2013 by Best Lawyers in America. He holds a BS from the Susquehanna University and JD from the Widener University School of Law. We believe Mr. Dogum's operational, executive and professional experience qualifies him to serve as a member of our Board and our Audit Committee.
Section 16(a) of the Securities Exchange Act of 1934 requires our directors, executive officers and 10% shareholders to file initial reports of ownership and reports of changes
in ownership of our common stock and other equity securities with the Securities and Exchange Commission (the "SEC"). The directors, executive officers and 10% shareholders are required to furnish us with copies of all Section 16(a) reports they file. Based on a review of the copies of such reports furnished to us and written representations from our directors and executive officers that no other reports were required, we believe that our directors, executive officers and 10% shareholders complied with all Section 16(a) filing requirements applicable to them for the year ended June 30, 2022.
Code of Conduct and Ethics
Our board of directors has adopted a Code of Conduct and Ethics, which applies to all of our directors, the principal executive officer, principal financial officer, principal accounting officer or controller
and persons performing similar functions, officers and employees. Our Code of Conduct and Ethics is posted in the “Corporate Governance” section of our Internet web site at www.escalonmed.com. Any amendments to, or grant of waiver with respect to, any provision of our Code of Conduct and Ethics, will be disclosed noting the nature of such amendment or waiver in the “Corporate Governance” section of our Internet web site at www.escalonmed.com or by other appropriate means as required or
permitted under the applicable regulations of the SEC.
Audit Committee Members and Financial Expert
The members of the audit committee of our board of directors are Ms. Napolitano, Mr. Trusk, John P. Dogum and David J. Jocavini. Our board of directors has determined that each audit member has the attributes, education and experience of, and therefore is, an “audit committee financial expert,” as such term is defined in Item 407(d)(5) of Regulation S-K, and that each member of our audit committee is “independent,” as such term is defined in the applicable regulations of the Securities.
ITEM
11.
EXECUTIVE COMPENSATION
Overview of Executive Employment Agreements and Equity-Based Awards
On February 14, 2018, the Company entered into a Debt Exchange Agreement (the “Exchange Agreement”) with Mr. DePiano Sr., the Company's former Chairman and DP Associates Inc. Profit-Sharing Plan of which Mr. DePiano Sr. is the sole owner and sole trustee (the “Holders”). Pursuant to the terms of the Exchange Agreement, effective February 15, 2018, the Holders exchanged a total of $645,000 principal amount of debt
related to the accounts receivable factoring program for 2,000,000 shares of Series A Convertible Preferred Stock (the “Preferred Stock”).
Each share of Preferred Stock entitles the Holder thereof to 13 votes per share and will vote together with all other classes and series of stock of the Company as a single class on all actions to be taken by the Company’s stockholders. As a result of this voting power, the Holders as of June 30, 2022 beneficially own approximately 77.81% of the voting power on all actions to be taken by the Company’s shareholders.
Subject
to the terms and conditions of Preferred Stock, the holder of any share or shares of the Preferred Stock has the right, at its option at any time, to convert each such share of Preferred Stock (except that, upon any liquidation of the Company, the right of conversion will terminate at the close of business on the business day fixed for payment of the amounts distributable on the Preferred Stock) into 2.15 shares of Common Stock (the “Conversion Ratio”). The Conversion Ratio is subject to standard provisions for adjustment in the event of a subdivision or combination of the Company’s Common Stock and upon any reorganization or reclassification of the capital stock of the Company. If the Holders were to convert
their shares of Preferred Stock into Common Stock at the Conversion Ratio the Holders would receive a total of 4,300,000 shares of Common Stock, or approximately 36.70% of the then outstanding shares of Common Stock assuming such conversion.
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Each outstanding share of the Preferred Stock accrues dividends calculated cumulatively at the annual rate of $.0258 per share (such amount subject to equitable adjustment in the event of any stock dividend, stock split, combination, reclassification other similar event), payable upon the earlier of (i) a liquidation, dissolution or winding up of the Company or (ii) conversion of the Preferred Stock into Common
Stock. Upon either of such events, all such accrued and unpaid dividends, whether or not earned or declared, to and until the date of such event, will become immediately due and payable and will be paid in full. The dividends payable to the holders of the Preferred Stock is payable in cash or, at the election of any such holder, in a number of additional shares of Common Stock equal to the amount of the dividend expressed in dollars divided by the then applicable Conversion Ratio, described above. As of June 30, 2022 and 2021 the cumulative dividends payable is $225,731 ($0.1129 per share) and $174,131 ($0.0871 per share), respectively.
Mr. DePiano Sr. passed away on October 3, 2019 and left a will by which he appointed Richard
J. DePiano, Jr., the Chief Executive Officer of the Company, as executor. Richard DePiano Jr. was elected to serve as chairman of the Company's board. Mr. DePiano, Jr. qualified as executor and has control over the listed shares in his capacity as executor of Mr. DePiano Sr.'s estate.
Compensation of Named Executive Officers
Summary Compensation Table
The following table sets forth certain summary information concerning compensation that we paid or accrued to or on behalf of each of our executive officers (the “Named Executive Officers”) during each of the fiscal years ended June 30,
2022, 2021 and 2020.
The compensation committee of our board recommends director compensation to our board of directors based on factors it considers appropriate, market conditions and trends and the recommendations of management. In fiscal 2022, none of our non-employee directors received any compensation.
Accounting and Tax Considerations
On July 1, 2007, we adopted in the FASB issued authoritative guidance related to share based payments. Under this accounting standard, we are required to value stock options granted in fiscal year 2007 and in subsequent fiscal years under the fair value method and expense those amounts in the income statement over the vesting period of the stock option. We were also required to value unvested stock options granted
prior to our adoption of the FASB issued authoritative guidance related to share based payments under the fair value method and amortize such expense in the income statement over the stock option’s remaining vesting period. A material portion of such amortizing expense relates to option grants made to our executive officers.
ITEM 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Security Ownership of Certain Beneficial
Owners and Management
The following table indicates, as of September 27, 2022 information about the beneficial ownership of our common stock by (1) each director as of September 27, 2022, (2) each Named Executive Officer, (3) all directors and executive officers as of September 27, 2022 as a group and (4) each person who we know beneficially owns more than 5% of our common stock. All such shares were owned directly with sole voting and investment power unless otherwise indicated.
Beneficial Ownership Table
51
Name
(1)
Amount of Beneficial Ownership of Outstanding Shares (1)
Percent of Class
Amount of Beneficial Ownership of Shares Underlying Options
All
Directors and Executive Officers as a group (7 persons)
4,441,083
59.9
%
109,000
4,550,083
60.1
%
(*)
Less than one
percent
(1)Information furnished by each individual named. This table includes shares that are owned jointly, in whole or in part with the person’s spouse, or individually by his or her spouse. No shares held by board members or named executive officers are pledged as collateral.
(2) Includes the shares of Mr. Depiano Sr. as Mr. DePiano, Jr. qualified as executor and has control over the listed shares in his capacity as executor of Mr. DePiano.Sr.'s estate.
Equity Compensation Plan Information
The following table sets forth information, as of June 30, 2022, with respect to compensation plans under which shares of our
common stock are authorized for issuance.
Plan Category
Number of Shares to be issued upon exercise of outstanding stock options (a)
Weighted-average exercise price of outstanding stock options (b)
Number of securities remaining available
for future issuance under equity compensation plans (excluding securities reflected in column a)) (c)
Equity Compensation plans approved by shareholders
157,000
$
1.47
Equity Compensation plans not approved by shareholders
—
—
—
157,000
$
1.47
—
ITEM
13.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Related Person Transactions
We recognize that related person transactions present a heightened risk of conflicts of interest and can create the appearance of a conflict of interest. Therefore, all proposed related person transactions are disclosed to our board of directors before we enter into the transaction, and, if the transaction continues for more than one year, the continuation is reviewed annually by our board of directors.
On February 14, 2018, the Company entered into a Debt Exchange Agreement (the “Exchange Agreement”)
with Mr. DePiano Sr., the Company's former Chairman and DP Associates Inc. Profit-Sharing Plan of which Mr. DePiano Sr. is the sole owner and sole trustee (the “Holders”). Pursuant to the terms of the Exchange Agreement, effective February 15, 2018, the Holders exchanged a total of $645,000 principal amount of debt related to the accounts receivable factoring program for 2,000,000 shares of Series A Convertible Preferred Stock (the “Preferred Stock”).
Each share of Preferred Stock entitles the Holder thereof to 13 votes per share and will vote together with all other classes and series of stock of the Company as a single class on all actions
to be taken by the Company’s stockholders. As a
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result of this voting power, the Holders as of June 30, 2022 beneficially own approximately 77.81% of the voting power on all actions to be taken by the Company’s shareholders.
Subject to the terms and conditions of Preferred Stock, the holder of any share or shares of the Preferred Stock has the right, at its option at any time, to convert each such share of Preferred Stock (except that, upon any liquidation of the
Company, the right of conversion will terminate at the close of business on the business day fixed for payment of the amounts distributable on the Preferred Stock) into 2.15 shares of Common Stock (the “Conversion Ratio”). The Conversion Ratio is subject to standard provisions for adjustment in the event of a subdivision or combination of the Company’s Common Stock and upon any reorganization or reclassification of the capital stock of the Company. If the Holders were to convert their shares of Preferred Stock into Common Stock at the Conversion Ratio the Holders would receive a total of 4,300,000 shares of Common Stock, or approximately 36.70% of the then outstanding shares of Common Stock assuming such conversion.
Each
outstanding share of the Preferred Stock accrues dividends calculated cumulatively at the annual rate of $.0258 per share (such amount subject to equitable adjustment in the event of any stock dividend, stock split, combination, reclassification other similar event), payable upon the earlier of (i) a liquidation, dissolution or winding up of the Company or (ii) conversion of the Preferred Stock into Common Stock. Upon either of such events, all such accrued and unpaid dividends, whether or not earned or declared, to and until the date of such event, will become immediately due and payable and will be paid in full. The dividends payable to the holders of the Preferred Stock is payable in cash or, at the election of any such holder, in a number of additional shares of Common Stock equal to the amount of the dividend expressed in dollars divided by the then applicable Conversion Ratio,
described above. As of June 30, 2022 and 2021 the cumulative dividends payable is $225,731 ($0.1129 per share) and $174,131 ($0.0871 per share), respectively.
Mr. DePiano Sr. passed away on October 3, 2019 and left a will by which he appointed Richard J. DePiano, Jr., the Chief Executive Officer of the Company, as executor. Richard DePiano Jr. was elected to serve as chairman of the Company's board. Mr. DePiano, Jr. qualified as executor and has control over the listed shares in
his capacity as executor of Mr. DePiano Sr.'s estate.
In
the table above, pursuant to definitions under the applicable regulations of the SEC, “audit fees” are fees for professional services rendered for the audit of our annual financial statements and review of our financial statements included in our quarterly reports on Form 10-Q and for services that are normally provided by the accountant in connection with statutory and regulatory filings or engagements; “audit-related fees” are fees for assurance and related services that are reasonably related to the performance of the audit and review of our financial statements, and primarily include accounting consultations and audits in connection with potential acquisitions; “tax fees” are fees for tax compliance, tax advice and tax planning; and “all other fees” are fees for any services not included in the first three categories.
Our audit committee is responsible for pre-approving all audit services
and permitted non-audit services to be performed by our principal accountant, except in those instances which do not require such pre-approval pursuant to the applicable regulations of the SEC. The audit committee has established policies and procedures for its pre-approval of audit
53
services and permitted non-audit services and, from time to time, the audit committee reviews and revises its policies and procedures for pre-approval.
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
1.Documents Filed as Part of This Annual Report on Form 10-K:
a.Financial Statements
The following consolidated financial statements of the Company and its subsidiaries are included in Part II, Item 8 of this Annual Report on Form 10-K:
Report of Independent Registered Public Accounting Firm (PCAOB ID i711)
Consolidated Statements of Operations for the years ended June 30, 2022 and 2021
Consolidated Statements of Shareholders’ Equity for the years ended June 30, 2022 and 2021
Consolidated Statements of Cash Flows for the years ended June 30, 2022 and 2021
Notes to Consolidated Financial Statements
2.Financial
Statement Schedules
All other schedules have been omitted because the required information is not applicable or the information is included in the Company’s Consolidated Financial Statements or the related Notes to Consolidated Financial Statements.
3.EXHIBITS
The following is a list of exhibits filed as part of this Annual Report on Form 10-K, where so indicated by footnote, exhibits that were previously filed, are incorporated by reference. For exhibits incorporated by reference, the location of the exhibit in the previous filing is indicated parenthetically, followed by the footnote
reference to the previous filing.
Filed as an exhibit to Pre-Effective Amendment No. 2 to the Company’s Registration Statement on Form S-1 dated November 9, 1993 (Registration No. 33-69360).
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
