ESCALON MEDICAL CORP - Annual Report: 2010 (Form 10-K)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended June 30, 2010
Commission File Number 0-20127
Commission File Number 0-20127
Escalon Medical Corp.
(Exact name of registrant as specified in its charter)
Pennsylvania | 33-0272839 | |
(State or other jurisdiction of | (I.R.S. Employer | |
incorporation or organization) | Identification No.) |
435 Devon Park Drive, Building 100, Wayne, PA 19087
(Address of principal executive offices, including zip code)
(Address of principal executive offices, including zip code)
(610) 688-6830
(Registrants telephone number, including area code)
(Registrants telephone number, including area code)
Securities Registered Pursuant to Section 12(b) of the Act:
Common Stock, par value $0.001 | NASDAQ Capital Market | |
(Title of class) | (Name of each exchange on which registered) |
Securities Registered Pursuant to Section 12(g) of the Act: NONE
Indicate by check mark if the registrant is a well-known seasoned issuer as defined in Rule
405 of the Securities Act. Yes o No þ
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 o No þ
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. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and
posted on its corporate website, 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).
Yes o No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation
S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of
registrants knowledge, in definitive proxy or information statements incorporated by reference in
Part III of this Form 10-K or any amendment to this Form 10-K. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of
large accelerated filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
Large accelerated filer o | Accelerated filer o | Non-accelerated filer o | Smaller reporting company þ | |||
(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Act). Yes o No þ
The aggregate market value of the voting and non-voting common equity held by
non-affiliates of the registrant on December 31, 2009 was approximately $11,816,495, computed by
reference to the price at which the common equity was last sold on the NASDAQ Capital Market on
such date.
As of September 27, 2010, the registrant had 7,526,430 shares of common stock
outstanding.
Documents Incorporated by Reference:
Certain information required by Part III of this Annual Report on Form 10-K will be set
forth in, and is incorporated by reference from, the registrants Proxy Statement for the 2010
Annual Meeting of Shareholders.
Escalon Medical Corp.
Annual Report on Form 10-K
For the Fiscal Year Ended June 30, 2010
Annual Report on Form 10-K
For the Fiscal Year Ended June 30, 2010
TABLE OF CONTENTS
Page | ||||||
PART I | ||||||
Item 1. |
Business | 1 | ||||
Item 1A. |
Risk Factors | 6 | ||||
Item 1B. |
Unresolved Staff Comments | 14 | ||||
Item 2. |
Properties | 14 | ||||
Item 3. |
Legal Proceedings | 15 | ||||
Item 4. |
(Removed and Reserved) | 15 | ||||
PART II | ||||||
Item 5. |
Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 15 | ||||
Item 7. |
Managements Discussion and Analysis of Financial Condition and Results of Operations | 16 | ||||
Item 7A. |
Quantitative and Qualitative Disclosures About Market Risk | 34 | ||||
Item 8. |
Financial Statements and Supplementary Data | 36 | ||||
Item 9. |
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 69 | ||||
Item 9A. |
Controls and Procedures | 69 | ||||
Item 9B. |
Other Information | 70 | ||||
PART III | ||||||
Item 10. |
Directors, Executive Officers and Corporate Governance | 70 | ||||
Item 11. |
Executive Compensation | 70 | ||||
Item 12. |
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 70 | ||||
Item 13. |
Certain Relationships and Related Transactions, and Director Independence | 70 | ||||
Item 14. |
Principal Accounting Fees and Services | 71 | ||||
PART IV | ||||||
Item 15. |
Exhibits, Financial Statement Schedules | 71 |
ii
PART 1
ITEM 1. BUSINESS
Company Overview
Escalon Medical Corp. (Escalon or the 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 and its wholly owned subsidiaries:
Sonomed, Inc. (Sonomed), Escalon Vascular Access, Inc. (Vascular), Escalon Medical Europe GmbH
(EME), Escalon Digital Vision, Inc. (EMI), Escalon Pharmaceutical, Inc. (Pharmaceutical),
Escalon Holdings, Inc. (EHI), Escalon IP Holdings, Inc., Escalon Vascular IP Holdings, Inc.,
Sonomed IP Holdings, Inc., Drew Scientific Holdings, Inc. and Drew Scientific Group, Plc (Drew)
and its subsidiaries. The Company sold certain assets of the Vascular business for $5,750,000 on
April 30, 2010 to Vascular Solutions, Inc. (see footnote 13 to the Notes to Consolidated Financial
Statements for additional information).
The Company operates in the healthcare market specializing in the development, manufacture
marketing and distribution of medical devices and pharmaceuticals in the areas of ophthalmology,
diabetes and hematology. 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 governmental
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. The
Companys Internet address is www.escalonmed.com.
Drew Business
Drew is a diagnostics company specializing in the design, manufacture and distribution of
instruments for blood cell counting and blood analysis. Drew is focused on providing
instrumentation and consumables for the physician office and veterinary office laboratories. Drew
also supplies the reagent and other consumable materials needed to operate the instruments. Drew
acquired JAS Diagnostics, Inc. (JAS) on May 29, 2008. JAS was established in 2000 and
specializes in the manufacture of a broad range of liquid stable, diagnostics chemistry reagents
used in IVD tests. Many of these reagents are single vial stable, which offer ease of use,
increased speed of results and extended on-board stability. Drew acquired certain assets of
Biocode Hycel (Biocode) on December 31, 2008. Biocode specializes in the hematology consumables
for the physician office and veterinary office laboratories. The operating results of JAS and
Biocode are included as part of the Drew business segment as of May 29, 2008 and December 31, 2008,
respectively.
Diabetes Testing
Drew sells two diabetic testing products: the DS5 and the Hb-Gold. The DS5 instrument,
dispenser and associated reagent kit measure long-term glucose control in diabetic patients. The
systems small size and ease of use make it ideal for main laboratory, clinic or satellite
laboratory settings. The Hb-Gold instrument and associated reagent kit provides for the in vitro
measurement of certain genetic diseases of the blood. In the United States, this instrument is
available for research only.
Hematology
Drew offers a broad array of equipment for use in the field of human and veterinary
hematology. Drews Excell product lines are for use in the field of human hematology, and its
Hemavet product line is for use in the veterinary field. The acquisition of Biocode added
proprietary hematology reagents to the Drew hematology reagent portfolio of products.
1
Sonomed Business
Sonomed develops, manufactures and markets ultrasound systems for diagnostic or biometric
applications in ophthalmology. The systems are of four types: A-Scans, B-Scans, High Frequency
B-Scans (UBMs) and pachymeters.
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 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. With the advent of refractive surgery (where the cornea is actually
cut and reshaped) this measurement has become critical. Surgeons must know the precise thickness
of the cornea so as to set the blade to make a cut of approximately 20% of the thickness of the
cornea.
EMI Business
EMI markets a CFA (Color/Fluorescein Angiography) digital imaging system, designed
specifically for ophthalmology. This diagnostic tool, ideal for use in detecting retinal problems
in diabetic and elderly patients, provides a high-resolution image, far superior to conventional
film in image quality, processing and capture. The instant image display provides users with the
necessary clinical information that allows treatment to be performed while the patient is still in
the physicians office.
Medical/Trek Business
Medical/Trek manufactures and distributes ophthalmic surgical products under the Companys
and/or Medical/Trek Medical Products names. Vitreoretinal ophthalmic surgeons primarily utilize
the following products.
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
2
distribution agreement with Scott Medical Products (Scott), the Company distributes packages
of Scott 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.
Viscous Fluid Transfer Systems
The Company markets viscous fluid transfer systems and related disposable syringe products,
which aid surgeons in the process of injecting and extracting silicone oil. Adjustable pressures
and vacuums provided by the equipment allow surgeons to manipulate the flow of silicone oil during
surgery.
Fiber Optic Light Sources
Light source and fiber optic products are widely used by vitreoretinal surgeons during
surgery. The Company offers surgeons a complete line of light sources along with a variety of
fiber optic probes and illuminated tissue manipulators.
Research and Development
The Company conducts development of medical devices for the diagnosis and monitoring of
medical disorders in the areas of diabetes, cardiovascular diseases and hematology at the Companys
Dallas, Texas, Miami, Florida and Rennes, France facilities. The Company conducts medical device
and vascular access product development at its New Berlin, Wisconsin facility. The development of
ultrasound ophthalmic equipment is performed at the Companys Lake Success, New York facility on
Long Island. Company-sponsored research and development expenditures from continuing operations
for the fiscal years ended June 30, 2010, 2009 and 2008 were approximately $1,893,000, $3,256,000,
and $3,798,000, respectively.
Manufacturing and Distribution
The Company leases an aggregate of 79,865 square feet of space at its facilities in Texas,
Connecticut, France and the United Kingdom and Florida. These sites are currently used for
engineering, product design and development and product assembly. All of the Companys medical
devices and consumables for the diagnosis and monitoring of medical disorders in the areas of
diabetes, cardiovascular diseases and hematology are distributed from the Companys Dallas, Texas,
Oxford, Connecticut, Miami, Florida, Rennes, France, and Barrow-in-Furness, United Kingdom
facilities. See Business Conditions in Managements Discussion and Analysis of Financial
Condition of Results of Operations for additional information.
The Company leases 13,500 square feet of space in Wisconsin, for its surgical products. and
vascular access operations prior to its sale on April 30, 2010. The facility is currently used for
product assembly related to Medical/Trek. The Company also leases 3,452 square feet in Lawrence,
Massachusetts used primarily for product design and development in the EMI business unit. The
Company subcontracts component manufacture, assembly and sterilization to various vendors. The
Companys ophthalmic surgical products are distributed from the Companys Wisconsin facility.
The Company designs, develops and services its ultrasound ophthalmic products at its 12,173
square foot facility in Lake Success, New York. The Company has achieved ISO13485 certification at
all of its manufacturing facilities for all medical devices, ultrasound devices and consumables the
Company produces. ISO13845 requires an implemented quality system that applies to product design.
These certifications can be obtained only after a complete audit of a companys quality system by
an independent outside auditor. These certifications require that facilities undergo periodic
reexamination. The Company has obtained European Community certification (CE) for disposable
delivery systems, fiber optic light probes, medical devices and consumables for the diagnosis and
monitoring of medical disorders in the areas of diabetes, cardiovascular diseases and hematology,
vascular access products and certain ultrasound models.
3
The manufacture, testing and marketing of each of the Companys products entails risk of
product liability. The Company carries product liability insurance to cover primary risk.
Governmental Regulations
The Companys products are subject to stringent ongoing regulation by the FDA and similar
health authorities, and if these governmental approvals or clearances of the Companys products are
restricted or revoked, the Company could face delays that would impair the Companys 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 impose substantial requirements upon the
manufacturing and marketing of pharmaceutical and medical device equipment and related disposables,
including the obligation to adhere to the FDAs Good Manufacturing Practice regulations.
Compliance with these regulations requires time-consuming detailed validation of manufacturing and
quality control practices, 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 FDA and similar health authorities in foreign countries extensively regulate the Companys
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 Companys products that allows the
Company to sell the products in the countries comprising the European Community. In addition to
the CE mark, some foreign countries require separate individual foreign regulatory clearances.
Marketing and Sales
The Drew business segment sells its products through internal sales and marketing employees
located in the United States, France and in the United Kingdom, as well as through a large network
of distributors, both domestic and international.
The Sonomed product line is sold through internal sales employees as well as independent sales
representatives located in the United States and Europe, to a large network of distributors and
directly to medical institutions.
The Medical/Trek and EMI business segments sell their ophthalmic devices and instruments
directly to end users through internal sales and marketing employees located at the Companys
Wisconsin and Massachusetts facilities. Sales are primarily made to teaching institutions, key
hospitals and eye surgery centers, focusing primarily on physicians and operating room personnel
performing vitreoretinal surgery. The EMI product line is sold through internal sales employees
and independent sales representatives in the United States.
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 Wisconsin facility for surgical devices, vascular access products and EMI devices. Sonomeds
products are serviced at the Companys New York facility. Drews products are serviced at its
Dallas, Texas and Barrow-in-Furness, UK facilities.
4
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 Companys position in the market place and protecting the Companys economic
interests. The Companys 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 Companys 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 Companys patents, trademarks and licenses
vary through 2020. The Company has 13 United States patents and 28 patents issued abroad that
cover the Companys surgical products and pharmaceutical technology. Drew has approximately 72
patents related to its technology.
On February 27, 2008, the Company settled all outstanding disputes and litigation with
Intralase, Corp. (Intralase) pursuant to which the Company transferred to Intralase its ownership
of all patents and intellectual property related the Companys ultrafast laser technology formerly
licensed to Intralase, the license agreement was terminated, and Intralase made a lump-sum payment
to the Company of $9,600,000.
The Company intends to vigorously defend its patents if the need arises.
While in the aggregate the Companys patents are of material importance to its business taken
as a whole, the patents, trademarks and licenses that are the most critical to the Companys
ability to generate revenues is:
The Escalon trademark is due for renewal on January 19, 2013, and the Company intends to renew
the trademark. The Sonomed trademark was renewed in November 2006.
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 prescription ophthalmic pharmaceuticals, ophthalmic devices, consumer products
and other eye care products; large integrated pharmaceutical companies that market a limited number
of ophthalmic pharmaceuticals in addition to many other pharmaceuticals; and smaller specialty
pharmaceutical and biotechnology companies that are engaged in the development and
commercialization of prescription ophthalmic pharmaceuticals and products and, to some extent, drug
delivery systems. The Companys competitors for medical devices and ophthalmic pharmaceuticals
include, but are not limited to, Bausch & Lomb, Inc., Alcon Laboratories, Inc., Paradigm Medical,
Inc., Quantel, Inc. and Accutome, Inc.
Several large companies dominate the ophthalmic market, with the balance of the industry being
highly fragmented. The Company believes that these large companies capture approximately 85% of
the overall ophthalmic market. The balance of the market is 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 Companys strategy
is to compete primarily on the basis of technological innovation to which it has proprietary
rights. The Company believes, therefore, that its success will depend in large part on protecting
its intellectual property through patents and other governmental regulations.
Sonomeds principal competitors are Alcon Laboratories, Inc, 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 within the United States market. Various competitors offering similar products at a lower
price could threaten Sonomeds market position. The development of laser technologies for
ophthalmic biometrics and imaging
5
may also diminish the Companys market position. This equipment can be used instead of
ultrasound equipment in most, but not all, patients. Such equipment, however, is more expensive.
The Medical/Trek and EMI businesses sell a broad range of ophthalmic surgical and diagnostic
products. The more significant products are ISPAN® gases and delivery systems. Medical/Trek and
EMI also manufacture various ophthalmic surgical products for major ophthalmic companies to be sold
under their names. To remain competitive, the Company needs to maintain a low-cost operation.
There are numerous other companies that can provide this manufacturing service. There are a
variety of other devices that directly compete with the camera back marketed by EMI.
Drew is a diagnostics company specializing in the design, manufacture and distribution of
instruments for blood cell counting and blood analysis. Drew is focused on the market for the
physician office and veterinary office laboratories. Drews principal competition is Beckman
Coulter and Bayer Diagnostics in the human market and IDDEX in the veterinary market. Currently
Drew has only a nominal share of these markets, and the Company will seek to increase Drews market
share. The Companys strategy is to market instruments and consumables that are competitive for
the low volume users in the domestic and overseas markets. Drews success will depend on its
ability to enhance its current product range and control its production costs. Drew recognizes
that other companies may adopt similar strategies which could hinder Drews ability to increase
market share.
Human Resources
As of June 30, 2010, the Company employed 178 employees. Of these employees, 87 of the
Companys employees are employed in manufacturing, 61 are employed in general and administrative
positions, 14 are employed in sales and marketing and 16 are employed in research and development.
The Companys employees are not covered by a collective bargaining agreement, and the Company
considers its relationship with its employees to be good.
ITEM 1A. RISK FACTORS
Cautionary Factors That May Affect Future Results
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 Companys 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 Companys products, the
Companys 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, defending the Company in litigation matters and the Companys
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 Companys 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 Companys other filings with the Securities and Exchange Commission (the SEC). In some
cases, these
6
factors have impacted, and in the future (together with other unknown factors) could impact,
the Companys ability to implement the Companys 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 Companys
filings with the SEC. Although it is not possible to create a comprehensive list of all factors
that may cause actual results to differ from the Companys forward-looking statements, the material
factors include, without limitation, the following:
Due to the Companys history of operating losses, the Companys auditors are uncertain that
the Company will be able to continue as a going concern.
The financial statements included in this report have been prepared assuming that the Company
will continue as a going concern. The independent auditors report issued in conjunction with the
financial statements for the year ended June 30, 2010 contains an explanatory paragraph indicating
that certain matters (see footnote 1 to the Consolidated Financial Statements) raise substantial
doubt about the Companys ability to continue as a going concern. The Company cannot guarantee that
it can generate net income, increase revenues or successfully expand its operations in the future,
and if it cannot do so, the Company may not be able to survive and any investment in the Company
may be lost.
The Company is implementing an austerity plan to stem the recurring losses at Drew. If the
Company is unable to achieve improvement in this area in the near term, it is not likely that the
Companys existing cash and cash flow from operations will be sufficient to fund activities
throughout the next 12 months without curtailing certain business activities. The Companys
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 other factors, including the factors discussed in
Risk Factors.
Because the Companys auditors have expressed a going concern qualification, the Companys
ability to obtain additional financing could be adversely affected.
Because of continued losses, negative cash flows and debt payments, the Company has included
going concern disclosure in Note 1 to its consolidated financial statements included in this
report, addressing substantial doubt about the Companys ability to continue as a going concern.
This going concern disclosure could adversely affect the Companys ability to obtain favorable
financing terms in the future or to obtain any additional financing if needed. If the Company
seeks to raise funds in the future, it may be required to raise those funds through public or
private financings, strategic relationships or other arrangements at prices or other terms that may
not be as favorable as they would absent such qualification. The sale of additional equity and debt
securities may result in additional dilution to the Companys stockholders. Additional financing
may not be available in amounts or on terms acceptable to the Company or at all.
Any acquisitions, strategic alliances, joint ventures and divestitures that the Company
effects 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, the Companys financial results may differ from the investment
communitys 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
7
have difficulty developing, manufacturing and marketing the products of a newly acquired business
in a way that enhances the performance of the Companys combined businesses or product lines to
realize the value from any expected synergies. Depending on the size and complexity of an
acquisition, the Companys 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 Companys attention from other business operations. Also, the Companys 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 Companys growth.
The Company continues to have recurring losses from prior acquisitions
The Company has incurred recurring operating losses and negative cash flows from operating
activities related to its Drew division which includes the recently acquired Biocode. The Company
is experiencing lower than expected sales from Biocode related to reduced instrument sales due to
uncertainty surrounding pending regulatory changes under French law. The Company does not know when
this uncertainty will be resolved nor what impact the new law if enacted will have on Biocodes
revenues in the future. For the year ended June 30, 2010, Biocode generated a net loss of $636,000.
Also, since the acquisition of Drew the Company loaned approximately $29 million to Drew, and during fiscal
year ended June 30, 2010 invested additional capital in Biocode of approximately $1,200,000. The
funds were primarily used to procure components to build up inventory to support the manufacturing
process, to pay off accounts payable and debt of Drew, and to expand the sales and marketing and
research and development efforts, to fund new product development and underwrite operating losses
since its acquisition. The Company cannot rule out that further working capital will be required by
Drew and Biocode. If the Company does not realize the expected benefits or synergies of such
transactions, the Companys consolidated financial position, results of operations and stock price
could be negatively impacted.
The Companys 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:
| Acquisitions, such as Drew, JAS and certain assets of Biocode and subsequent integration of the acquired business; | ||
| 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 Companys products; | ||
| Fluctuations in customer demand for the Companys products; | ||
| Fluctuations in royalty income; | ||
| 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
Companys expectations of product orders and shipments during that quarter. A shortfall in
revenue, therefore, in any particular quarter as compared to the Companys plan could have a
material adverse impact on the Companys results of operations and cash flows. Also, the Companys
quarterly results could fluctuate due to general market conditions in the healthcare industry or
global economy generally, or market volatility unrelated to the Companys business and operating
results.
8
The Companys cost saving initiatives may not be effective and the Companys ability to
develop products could be adversely affected by reduced research and development.
The Company has implemented cost-saving initiatives that may not be effective in returning the
Company to profitability. If these initiatives are insufficient, additional measures may be
necessary. The cost savings initiatives include a reduction in research and development expenses
which could hinder the Companys ability to update or introduce new products.
Failure of the market to accept the Companys products could adversely impact the
Companys business and financial condition.
The Companys business and financial condition will depend in part upon the market acceptance
of the Companys products. The Companys products may not achieve 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 Companys products; and | ||
| The advantages of the Companys products over those marketed by the Companys competitors. |
Any failure to achieve significant market acceptance of the Companys products will have a
material adverse impact on the Companys business.
The Companys products are subject to stringent ongoing regulation by the FDA and similar
health care regulatory authorities, and if the FDAs approvals or clearances of the Companys
products are restricted or revoked, the Company could face delays that would impair the Companys
ability to generate funds from operations.
The FDA and similar health care regulatory authorities in foreign countries extensively
regulate the Companys 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 Companys 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 FDAs 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 Companys 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
9
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 Companys financial resources and Companys managements time
and effort. Any delay in obtaining clearances or approvals or any changes in existing regulatory
requirements would materially adversely impact the Companys business.
The Companys 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
Companys business, financial condition and results of operations.
The success of products with which the Companys products compete could have an adverse impact
on the Companys 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 Companys competitors have substantially greater financial,
technical, marketing, distribution and other resources. The Companys strategy is to compete
primarily on the basis of technological innovation, reliability, quality and price of the Companys
products. Without timely introductions of new products and enhancements, the Companys products
will become technologically obsolete over time, in which case the Companys revenues and operating
results would suffer. The success of the Companys new product offerings will depend on several
factors, including the Companys ability to:
| Properly identify customer needs; | ||
| Innovate and develop new technologies, services and applications; | ||
| Establish adequate product distribution coverage; | ||
| Obtain and maintain required regulatory approvals from the FDA and other regulatory agencies; | ||
| Protect the Companys intellectual property; | ||
| Successfully commercialize new technologies in a timely manner; | ||
| Manufacture and deliver the Companys products in sufficient volumes on time; | ||
| Differentiate the Companys offerings from the offerings of the Companys competitors; | ||
| Price the Companys products competitively; | ||
| 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.
The Companys 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 Companys 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 Companys 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 Companys patents may not afford protection against competitors with similar
technology.
10
If a court determines that any of the Companys 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.
Lack of availability of key system components could result in delays, increased costs or
costly redesign of the Companys products.
Although some of the parts and components used to manufacture the Companys products are
available from multiple sources, the Company currently purchases most of the Companys components
from single sources in an effort to obtain volume discounts. Lack of availability of any of these
parts and components could result in production delays, increased costs or costly redesign of the
Companys products. Any loss of availability of an essential component could result in a material
adverse change to the Companys business, financial condition and results of operations. Some of
the Companys suppliers are subject to the FDAs Good Manufacturing Practice regulations. Failure
of these suppliers to comply with these regulations could result in the delay or limitation of the
supply of parts or components to the Company, which would adversely impact the Companys financial
condition and results of operations.
The Companys ability to market or sell the Companys products may be adversely impacted by
limitations on reimbursements by government programs, private insurance plans and other third party
payors.
The Companys customers bill various third party payors, including government programs and
private insurance plans, for the health care services provided to their patients. Third party
payors 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 Companys products was elective,
unnecessary, inappropriate, not cost-effective, experimental or used for a non-approved indication.
Third party payors may deny reimbursement notwithstanding FDA approval or clearance of a product
and may challenge the prices charged for the medical products and services. The Companys ability
to sell the Companys 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 Companys products.
Future legislation or changes in government programs may adversely impact the market for the
Companys 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 may take or its impact on the Companys 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 were to adversely impact those
markets, the Companys product marketing could also suffer, which would adversely impact the
Companys business.
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 Companys 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 Companys time
and attention away from the Companys core businesses. The Company maintains limited product
liability insurance coverage of $1,000,000 per occurrence and
11
$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 Companys financial condition and results of operations. The Companys product
liability insurance coverage may not continue to be available to the Company in the future on
reasonable terms or at all.
The Companys 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 Companys business in these countries and
the Companys 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 Companys results of operations.
The Company is dependent on its management and key personnel to succeed.
The Companys principal executive officers and technical personnel have extensive experience
with the Companys products, the Companys research and development efforts, the development of
marketing and sales programs and the necessary support services to be provided to the Companys
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 Companys executive officers or other technical personnel, or the Companys failure to attract
and retain other skilled and experienced personnel, could have a material adverse impact on the
Companys ability to maintain or expand businesses.
The market price of the Companys stock has historically been volatile, and the Company has
not paid cash dividends.
The volatility of the Companys 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 shareholders holdings of the Companys common stock. The
following factors have and may continue to have a significant impact on the market price of the
Companys 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 Companys 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 Companys 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.
The impact of terrorism or acts of war could have a material adverse impact on the Companys
business.
12
Terrorist acts or acts of war, whether in the United States or abroad, could cause damage or
disruption to the Companys 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 Companys business.
The Companys charter documents and Pennsylvania law may inhibit a takeover.
Certain provisions of Pennsylvania law and the Companys 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 Companys common stock. The Companys 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 Companys 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. The Company has no current plans to issue any shares of preferred stock.
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 Companys
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 related reserves, revenues, expenses and income.
This includes estimates, judgments and assumptions for assessing the recoverability of the
Companys goodwill and other intangible assets, pursuant to FASB issued authoritative guidence. 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 our earnings and could have a material adverse impact on our 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 Companys financial position
and operating results.
On an on-going basis, the Company evaluates its estimates, including, among others, those
relating to:
| product returns; | ||
| allowances for doubtful accounts; | ||
| inventories and related reserves; | ||
| intangible assets and goodwill; | ||
| income and other tax accruals; | ||
| deferred tax asset valuation allowances; | ||
| discounts and allowances; | ||
| warranty obligations; and | ||
| 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
13
sources. The Companys assumptions and estimates may, however, prove to have been incorrect and the
Companys 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 Companys assumptions or estimates, or any actual results which differ from the Companys
assumptions or estimates, could have a material adverse effect on the Companys financial position
and operating results.
Substantially all of the Companys cash and cash equivalents are held at a single financial institution. |
Substantially all of the Companys cash and cash equivalents and short-term marketable
securities are presently held at one national financial institution. Accordingly, the Company is
subject to credit risk if this financial institution is unable to repay the balance in the account
or deliver the Companys securities or if the financial institution should become bankrupt or
otherwise insolvent. Any of the above events could have a material and adverse effect on the
Companys business and financial condition.
Healthcare policy changes, including pending proposals to reform the U.S. healthcare system, 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 Companys products, or the amounts of reimbursement available for its products from
governmental agencies or third-party payors. These limitations could have a material adverse effect
on the Companys financial position and results of operations.
Changes in the healthcare industry in the U.S. and elsewhere could adversely affect the demand
for the Companys products as well as the way in which the Company conducts the Companys business.
On March 23, 2010, health reform legislation was approved by Congress and has been signed into
law. The reform legislation provides that most individuals must have health insurance, will
establish new regulations on health plans, and create insurance pooling mechanisms and other
expanded public health care measures.
The Company anticipates that out of the reform legislation will come a reduction in Medicare
spending on services provided by hospitals and other providers and a form of sales or excise tax on
the medical device manufacturing sector. Various healthcare reform proposals have also emerged at
the 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 governments role in the U.S. healthcare industry may
lower reimbursements for the Companys products, reduce medical procedure volumes and adversely
affect the Companys business, possibly materially. In addition, if the excise taxes contained in
the House or Senate health reform bills are enacted into law, the Companys operating expenses
resulting from such an excise tax and results of operations would be materially and adversely
affected.
ITEM 1B. UNRESOLVED STAFF COMMENTS
The Company does not believe there are any unresolved SEC staff comments.
ITEM 2. PROPERTIES
The Company currently leases an aggregate of 114,844 square feet of space for its (i)
corporate offices in Wayne, Pennsylvania, (ii) Drews administrative offices and/or manufacturing
facilities in Barrow-in-Furness, United Kingdom, Dallas, Texas, Rennes, France (BioCode), Miami,
Florida (JAS) and Waterford, Connecticut. (iii) Sonomed has a manufacturing facility in Lake
Success, New York, and (iv) Medical/Treks distribution facility in New Berlin, Wisconsin. (v)
EMIs product design and development facility in Lawrence, Massachusetts. The corporate offices in
Pennsylvania cover 5,854 square feet and
14
expire in July 2013. The facility in the United Kingdom covers 2,508 square feet whose lease
expires in January 2011. The facility in Texas covers 22,992 square feet whose lease expires in
March 2014. The facility in Rennes covers 31,215 square feet and expires in December 2017. The
Miami facility lease covers 20,000 square feet and expires in December 2013. The Connecticut
facility lease covers 3,150 square feet and expires in November 2017. The New York facility leases
covering 12,173 square feet, expires in August 2017. The Wisconsin lease, covering 13,500 square
feet of space expires in December 2010. The Massachusetts lease, covering 3,452 square feet is a
month to month lease. Annual rent under all of the Companys property lease arrangements was
approximately $928,540 for the year ended June 30, 2010.
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 Companys business, financial condition or results
of operations.
ITEM 4. (Removed and Reserved)
PART II.
ITEM 5. MARKET FOR REGISTRANTS COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
The Companys common stock trades on the NASDAQ Capital Market under the symbol ESMC. The
table below sets forth, for the periods indicated, the high and low sales prices as quoted on the
NASDAQ Capital Market.
High | Low | |||||||
Fiscal year ended June 30, 2010 |
||||||||
Quarter ended September 30, 2009
|
$ | 2.35 | $ | 1.73 | ||||
Quarter ended December 31, 2009
|
$ | 2.20 | $ | 1.45 | ||||
Quarter ended March 31, 2010
|
$ | 1.90 | $ | 1.43 | ||||
Quarter ended June 30, 2010
|
$ | 1.97 | $ | 1.43 | ||||
Fiscal year ended June 30, 2009 |
||||||||
Quarter ended September 30, 2008
|
$ | 3.12 | $ | 2.00 | ||||
Quarter ended December 31, 2008
|
$ | 2.00 | $ | 0.88 | ||||
Quarter ended March 31, 2009
|
$ | 2.30 | $ | 1.40 | ||||
Quarter ended June 30, 2009
|
$ | 2.35 | $ | 1.60 |
As of September 27, 2010, there were 1,264 holders of record of the Companys common
stock. On September 27, 2010 the closing price of the Companys Common Stock as reported by the
NASDAQ Capital Market was $1.74 per share.
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.
15
ITEM 7. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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 IA of this Form 10-K.
The Companys continuing operations are primarily in four reportable business segments: Drew,
Sonomed, Medical/Trek and EMI. Certain assets of the Vascular business were sold for $5,750,000 on
April 30, 2010 to Vascular Solutions, Inc (see footnote 13 of the Companys June 30, 2010 annual
consolidated financial statements for additional information).
Drew is a diagnostics company specializing in the design, manufacture and distribution of
instruments for blood cell counting and blood analysis. Drew is focused on providing
instrumentation and consumables for the physician office and veterinary office laboratories. Drew
also supplies the reagent and other consumable materials needed to operate the instruments. Drew
added to its reagent business with the May 29, 2008 purchase of JAS and the December 31, 2008
acquisition of certain assets of BioCode (see footnote 14 of the Companys June 30, 2010 annual
consolidated financial statements for additional information).
Sonomed develops, manufactures and markets ultrasound systems used for diagnosis or biometric
applications in ophthalmology.
Prior to its sale on April 30, 2010, Vascular developed, manufactured and marketed vascular
access products.
Medical/Trek develops, manufactures and distributes ophthalmic surgical products under the
Escalon Medical Corp. and/or Medical/Trek Medical Products names.
EMI manufactures and markets digital camera systems for ophthalmic fundus photography. For a
more complete description of these businesses and their products, see Item 1 Description of
Business.
Executive Overview Fiscal Years Ended June 30, 2010 and 2009
The following highlights are discussed in further detail within this Form 10-K. The reader is
encouraged to read this Form 10-K in its entirety to gain a more complete understanding of factors
impacting Company performance and financial condition.
| Product revenue from continuing operations increased approximately $57,000 or 0.2% during fiscal year ended June 30, 2010 as compared to the prior fiscal year. The increase is primarily related to decreased sales in the Companys Sonomed, and EMI business units which decreased approximately 12.2%, and 8.5% respectively, offset by sales increases in the Drew and Medical/Trek business units of 7.3% and 2.8%, respectively. | ||
| Other revenue from continuing operations increased approximately $852,000 or 640.6% during the fiscal year ended June 30, 2010, as compared to the prior fiscal year. The increase is due to the licensing of certain Biocode technology to TECOM for $888,000 in fiscal year 2010 (see footnote 12). | ||
| Cost of goods sold as a percentage of product revenue from continuing operations decreased to approximately 56.9% of product revenues during the fiscal year ended June 30, 2010, as compared to approximately 59.1% of product revenue for the prior fiscal year. Cost of goods sold in the Drew business segment was approximately 57.4% of product revenue during the fiscal year ended June 30, 2010, as compared to approximately 62.0% in the prior fiscal year. The aggregate cost |
16
of goods sold as a percentage of product revenue of the Sonomed, EMI and Medical/Trek business units during fiscal year ended June 30, 2010 increased to approximately 56.0% of product revenue from approximately 55.1% in the prior fiscal year. | |||
| Operating expenses increased approximately 7.8% during the fiscal year ended June 30, 2010 as compared to the prior fiscal year. This was due to increased marketing, general and administrative expenses of 20.2% offset by a 41.8% decrease in research and development expenses related to the decision to drastically reduce Sonomeds and Drews research and development department. |
Results of Operations
Fiscal Years Ended June 30, 2010 and 2009
The following table shows consolidated product revenue by business segment, as well as
identifying trends in business segment product revenues for the fiscal years ended June 30, 2010
and 2009. Table amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||
2010 | 2009 | % Change | ||||||||||
Product Revenue: |
||||||||||||
Drew |
$ | 19,403 | $ | 18,085 | 7.3 | % | ||||||
Sonomed |
8,055 | 9,175 | -12.2 | % | ||||||||
EMI |
1,902 | 2,078 | -8.5 | % | ||||||||
Medical/Trek |
1,297 | 1,262 | 2.8 | % | ||||||||
Total |
$ | 30,657 | $ | 30,600 | 0.2 | % | ||||||
Consolidated product revenue from continuing operations increased approximately $57,000
or 0.2%, to $30,657,000 during the year ended June 30, 2010 as compared to the last fiscal year.
In the Drew business unit, product revenue increased $1,318,000, or 7.3%, as compared to last
fiscal year. The increase in product revenue is related to the acquisition of Biocode in
December 2008. The year ended June 30, 2010 includes 12 months of Biocode operations as compared to
six months in the prior period.
Product revenue decreased $1,120,000, or 12.2%, to $8,055,000 in the Sonomed business segment
as compared to the last fiscal year. The decrease in product revenue was primarily caused by a
decrease in product revenue at Sonomeds European distributors related to the current difficult
economic climate in Europe. Sonomed cannot determine when or if European sales volumes will rebound
or if margins will materially improve. Overall weak economic conditions have also led to increased
sales discounts to Sonomeds distributors in order to entice end users to purchase or to compete
with toughening competition.
Product revenue decreased $176,000, or 8.5%, in the EMI business segment when compared to the
last fiscal year. The reduction is related to a general decline in the purchase of capital
equipment by EMIs customers related to the overall economic climate.
In the Medical/Trek business unit, product revenue increased $35,000, or 2.8% , to $1,297,000
during the year ended June 30, 2010, as compared to the last fiscal year. The increase in
Medical/Trek product revenue is attributed to Medical/Treks product line of Ispan intraocular
gases and fiber optic light sources. However, the Company does not intend to invest any funds to
develop or upgrade any new or existing Medical/Trek products.
17
The following table presents consolidated other revenue from continuing operations by
reportable business segment for the fiscal years ended June 30, 2010 and 2009. Table amounts are
in thousands:
Fiscal Years Ended June 30, | ||||||||||||
2010 | 2009 | % Change | ||||||||||
Other Revenue: |
||||||||||||
Drew |
$ | 985 | $ | 133 | 640.6 | % | ||||||
Sonomed |
| | 0.0 | % | ||||||||
EMI |
| | 0.0 | % | ||||||||
Medical/Trek |
| | 0.0 | % | ||||||||
Total |
$ | 985 | $ | 133 | 640.6 | % | ||||||
Consolidated other revenue increased by approximately $852,000, or 640.6%, to $985,000
during the fiscal year ended June 30, 2010, as compared to the prior fiscal year. These increases
are related to the licensing agreement entered into in June 2009 with TECOM (see footnote 12 to the
Consolidated Financial Statements), which accounted for approximately $888,000 in other revenue for
the year ended June 30, 2010. The increase related to the TECOM agreement was offset by lower
royalties earned from Bio-Rad related to an OEM agreement between Bio-Rad and Drew as a result of
lower sales of Drews products in covered areas. While this agreement terminated as of May 15,
2006, the parties have continued to operate under the terms of the expired agreement pending
negotiation of a potential extension and/or revision.
The following table presents consolidated cost of goods sold by reportable business segment
and as a percentage of related segment product revenues for the fiscal years ended June 30, 2010
and 2009. Table amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||||||
2010 | % | 2009 | % | |||||||||||||
Cost of Goods Sold: |
||||||||||||||||
Drew |
$ | 11,137 | 57.4 | % | $ | 11,207 | 62.0 | % | ||||||||
Sonomed |
4,558 | 56.6 | % | 4,974 | 54.2 | % | ||||||||||
EMI |
866 | 45.5 | % | 1,069 | 51.4 | % | ||||||||||
Medical/Trek |
881 | 67.9 | % | 848 | 67.2 | % | ||||||||||
Total |
$ | 17,442 | 56.9 | % | $ | 18,098 | 59.1 | % | ||||||||
Consolidated cost of goods sold from continuing operations totaled approximately
$17,442,000, or 56.9%, of product revenue from continuing operations, for the fiscal year ended
June 30, 2010, as compared to $18,098,000, or 59.1%, of product revenue from continuing
operations, for the prior fiscal year.
Cost of goods sold in the Drew business segment totaled $11,137,000, or 57.4%, of product
revenue, for the fiscal year ended June 30, 2010 as compared to $11,207,000, or 62.0%, of product
revenue, for the prior fiscal year. The decrease in the cost of goods sold as a percentage of
revenue is due to the acquisition of certain assets of Biocode on December 31, 2008. Sales at
Biocode consist primarily of higher margin reagent sales. In addition, the gross margin on Drews
DREW 3 instrument, which is manufactured
18
in France by an OEM partner, increased as a result of favorable Euro to Dollar exchange
fluctuations during the year ended June 30, 2010.
Cost of goods sold in the Sonomed business segment totaled $4,558,000, or 56.6%, of product
revenue, for the fiscal year ended June 30, 2010 as compared to $4,974,000, or 54.2% of product
revenue, for prior fiscal year. The increase in Sonomeds cost of goods sold as a percentage of
revenue is related to an increase in sales discounts during second half of the year ended June 30,
2010 as a result of sales to the more price sensitive international market and an obsolete
inventory write down of approximately $60,000 during the fourth quarter of the year ended June 30,
2010.
Cost of goods sold in the EMI business segment totaled $866,000, or 45.5%, of product revenue,
for fiscal year ended June 30, 2010, as compared to $1,069,000, or 51.4%, of product revenue, for
the last fiscal year. The decrease in cost of goods sold as a percentage of revenue is due to an
increase in sales of Digitals new high margin Axis product during the year ended June 30, 2010.
Cost of goods sold in the Medical/Trek business segment totaled $881,000, or 67.9% of product
revenue, for the fiscal year ended June 30, 2010, as compared to $848,000, or 67.2% of product
revenue, for the last fiscal year.
The following table presents consolidated marketing, general and administrative expenses as
well as identifying trends in business segment marketing, general and administrative expenses for
the fiscal years ended June 30, 2010 and 2009. Table amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||
2010 | 2009 | % Change | ||||||||||
Marketing, General and Administrative: |
||||||||||||
Drew |
$ | 10,285 | $ | 7,090 | 45.1 | % | ||||||
Sonomed |
1,834 | 2,485 | -26.2 | % | ||||||||
EMI |
614 | 601 | 2.2 | % | ||||||||
Medical/Trek |
2,959 | 2,885 | 2.5 | % | ||||||||
Total |
$ | 15,692 | $ | 13,061 | 20.2 | % | ||||||
Consolidated marketing, general and administrative expenses from continuing operations
increased $2,631,000, or 20.2%, to $15,692,000 during the fiscal year ended June 30, 2010, as
compared to the prior fiscal year.
Marketing, general and administrative expenses in the Drew business segment increased
$3,195,000, or 45.1%, to $10,285,000 as compared to the same period last fiscal year. The increase
is related to the acquisition of Biocode in December 2008. There are 12 months of activity included
in the year ended June 30, 2010 as compared to six months of activity in the prior period. In
addition, amortization expense increased approximately $200,000 during the year ended June 30, 2010
at the JAS business unit related to a change in the estimated life of the acquired customer list.
Marketing, general and administrative expenses in the Sonomed business segment decreased by
$651,000, or 26.2%, to $1,834,000 as compared to the prior fiscal year. The decrease is related to
an austerity plan that was implemented in June 2009. The plan included a reduction in force, pay
cuts of between 10%-20% for certain employees and reductions in trade shows, advertising,
commissions, and consulting expenses.
19
Marketing, general and administrative expenses in the EMI business segment increased $13,000
or 2.2% to $614,000 as compared to last fiscal year. The increase is related to increased
advertising and trade show activity during the second half of the year ended June 30, 2010.
The Medical/Trek business units marketing, general and administrative expenses increased
$73,000 or 2.5% to $2,959,000 as compared to the last fiscal year. The increase was due primarily
by increased insurance premiums and accrued discretionary bonuses offset by reductions in force,
lower compensation expense for directors, decreased expenses for third party consultants and legal
expenses.
The following table presents consolidated research and development expenses from continuing
operations by reportable business segment and as a percentage of related segment product revenues
for the fiscal years ended June 30, 2010 and 2009. Table amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||
2010 | 2009 | % Change | ||||||||||
Research and Development: |
||||||||||||
Drew |
$ | 957 | $ | 1,800 | -46.8 | % | ||||||
Sonomed |
560 | 1,085 | -48.4 | % | ||||||||
EMI |
361 | 362 | -0.3 | % | ||||||||
Medical/Trek |
16 | 9 | 77.8 | % | ||||||||
Total |
$ | 1,894 | $ | 3,256 | -41.8 | % | ||||||
Consolidated research and development expenses from continuing operations decreased
$1,362,000, or 41.8%, to $1,894,000 during the fiscal year ended June 30, 2010 as compared to the
prior fiscal year. Research and development expenses were primarily expenses associated with the
planned introduction of new or enhanced products in the Drew, Sonomed and EMI business units.
Research and development expenses in the Drew business segment decreased $843,000, or 46.8%,
to $957,000. The decrease is related to the completion of the DS-360 during the year ended June
30, 2009 and the June 2008 decision to disband the research and development department and rely on
outsourced consultants under the direction of Drew to conduct future research and development
projects on an as needed basis.
Research and development expenses in the Sonomed business segment decreased $525,000, or
48.4%, to $560,000 as compared to the last fiscal year. The decrease is related to the completion
of the PacScan Plus and the Master Vu A products and the decision to suspend further work on the
VuMax III.
Research and development in the EMI business segment decreased $1,000 or 0.3%, to $361,000 as
compared to the last fiscal year. Research and development expense is related to the continued
upgrading of our digital imaging product offering and fluctuates depending on the scope of
individual projects.
Gain on sale of assets was approximately $0 and $92,000 during the fiscal years ended June 30,
2010 and 2009, respectively, due to the sale of assets at Drew related to Drews decision to
outsource future machine shop operations. For the year ended June 30, 2010 the Company had net
income from discontinued operations of $3,474,351 which included a gain on the sale of certain
vascular assets of $3,493,311.
The Company recognized a loss of approximately $75,000 and $65,000 related to its investment
in Ocular Telehealth Management (OTM) during the fiscal years ended June 30, 2010 and 2009,
respectively. Commencing July 1, 2005, the Company began recognizing all of the losses of OTM in
its consolidated financial statements. OTM is an early stage privately held company. Prior to July
1, 2005, the
20
share of OTMs loss recognized by the Company was in direct proportion to the
Companys ownership equity in OTM. OTM began operations during the three-month period ended
September 30, 2004. (See note 13 of the notes to consolidated financial statements.)
Interest income was $0 and $19,000 for the fiscal years ended June 30, 2010 and 2009,
respectively. The decrease was due to lower cash balances.
Interest expense was $427,000 and $216,000 for the fiscal years ended June 30, 2010 and 2009,
respectively. The increase is related to increased debt related to the JAS and Biocode
acquisitions.
Results of Operations
Fiscal Years Ended June 30, 2009 and 2008
The following table shows consolidated product revenue from continuing operations by business
segment as well as identifying trends in business segment product revenues for the fiscal years
ended June 30, 2009 and 2008. Table amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||
2009 | 2008 | % Change | ||||||||||
Product Revenue: |
||||||||||||
Drew |
$ | 18,085 | $ | 13,332 | 35.7 | % | ||||||
Sonomed |
9,175 | 9,367 | -2.1 | % | ||||||||
EMI |
2,078 | 1,762 | 17.9 | % | ||||||||
Medical/Trek |
1,262 | 1,410 | -10.5 | % | ||||||||
Total |
$ | 30,600 | $ | 25,871 | 18.3 | % | ||||||
Consolidated product revenue increased approximately $4,729,000, or 18.3%, to $30,600,000
during the year ended June 30, 2009 as compared to the pervious fiscal year.
In the Drew business unit, product revenue increased $4,753,000, or 35.7%, as compared to the
fiscal year ended June 30, 2008. The increase is primarily due to the acquisition of JAS on May
29, 2008 and of Biocode Hycel on December 31, 2008 which combined increased revenue by $4,405,000.
The remainder of the increase is primarily due to strong sales of Drews DREW 3 instrument which
received FDA approval on December 18, 2008.
Product revenue decreased $192,000, or 2.1%, to $9,175,000 in the Sonomed business segment as
compared to the fiscal year ended June 30, 2008. This decrease in volume is related to the global
economic downturn and the effect it had on the ability of Sonomeds traditional customer base to
add additional or upgraded capital equipment at this time. These troubling economic conditions
also led to increased sales discounts to Sonomeds distributors in order to entice end users to
purchase or to compete with toughening competition. (see Goodwill Impairment-Sonomed below and
footnote 4 of notes to consolidated financial statements for further discussion).
Product revenue increased $316,000, or 17.9% to $2,078,000, in the EMI business segment, when
compared to the fiscal year ended June 30, 2008. The EMI product offering of digital imaging
systems continued to expand and saw increased market acceptance during the year ended June 30,
2009.
In the Medical/Trek business unit, product revenue decreased $148,000, or 10.5%, to $1,262,000
during the year ended June 30, 2009 as compared to the fiscal year ended June 30, 2008. The
decrease was related to the continued aging of Medical/Treks product offerings.
21
The following table presents consolidated other revenue by reportable business segment for the
fiscal years ended June 30, 2009 and 2008. Table amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||
2009 | 2008 | % Change | ||||||||||
Other Revenue: |
||||||||||||
Drew |
$ | 133 | $ | 222 | -40.1 | % | ||||||
Sonomed |
0 | 0 | 0.0 | % | ||||||||
EMI |
0 | 0 | 0.0 | % | ||||||||
Medical/Trek |
0 | 0 | 0.0 | % | ||||||||
Total |
$ | 133 | $ | 222 | -40.1 | % | ||||||
Consolidated other revenue decreased by approximately $89,000, or 40.1%, to $133,000
during the fiscal year ended June 30, 2009 as compared to the fiscal year ended June 30, 2008. The
decrease was due to decreased royalties earned from Bio-Rad royalty agreement (see footnote 11 of
notes to the consolidated financial statements).
The following table presents consolidated cost of goods sold from continuing operations by
reportable business segment and as a percentage of related segment product revenues for the fiscal
years ended June 30, 2009 and 2008. Table amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||||||
2009 | % | 2008 | % | |||||||||||||
Cost of Goods Sold: |
||||||||||||||||
Drew |
$ | 11,207 | 62.0 | % | $ | 8,928 | 67.0 | % | ||||||||
Sonomed |
4,974 | 54.2 | % | 5,029 | 53.7 | % | ||||||||||
EMI |
1,069 | 51.4 | % | 820 | 46.5 | % | ||||||||||
Medical/Trek |
848 | 67.2 | % | 995 | 70.6 | % | ||||||||||
Total |
$ | 18,098 | 59.1 | % | $ | 15,772 | 61.0 | % | ||||||||
Consolidated cost of goods sold totaled approximately $18,098,000, or 59.1%, of product
revenue, for the fiscal year ended June 30, 2009, as compared to $15,772,000, or 61.0%, of product
revenue, for the fiscal year ended June 30, 2008.
Cost of goods sold in the Drew business segment totaled $11,207,000, or 62.0%, of product
revenue, for the fiscal year ended June 30, 2009, as compared to $8,928,000, or 67.0%, of product
revenue, for the fiscal year ended June 30, 2008. The decrease in the cost of goods sold as a
percentage of revenue is due to the acquisitions of JAS on May 29, 2008 and certain assets of
Biocode on December 31, 2008. Sales at both of these divisions consist primarily of higher margin
reagent sales. These higher margin sales had been offset by margin compression related to the
continued strength of the Euro against the US Dollar which negatively affects the margins on Drews
new DREW 3 offering that is manufactured in France by an OEM partner.
Cost of goods sold in the Sonomed business segment totaled $4,974,000, or 54.2%, of product
revenue, for the fiscal year ended June 30, 2009 as compared to $5,029,000, or 53.7%, of product
revenue,
22
for the fiscal year ended June 30, 2008. The increase in Sonomeds cost of goods sold as
a percentage of revenue was primarily caused by an increase in sales discounts during the period as
a result of sales to the more price sensitive international market combined with a decrease in
overall domestic sales.
Cost of goods sold in the EMI business segment totaled $1,069,000, or 51.4%, of product
revenue, for fiscal year ended June 30, 2009, as compared to $820,000, or 46.5%, of product
revenue, for the fiscal year ended June 30, 2008. The increase as a percentage of product revenue
was due to the need to increase discounts related to the difficult economic environment experienced
during the current year.
Cost of goods sold in the Medical/Trek business segment totaled $848,000, or 67.2%, of product
revenue, for the fiscal year ended June 30, 2009, as compared to $995,000, or 70.6%, of product
revenue, for the fiscal year ended June 30, 2008. The decrease as a percentage of product revenue
was due to price increase to its customers.
The following table presents consolidated marketing, general and administrative expenses as
well as identifying trends in business segment marketing, general and administrative expenses for
the fiscal years ended June 30, 2009 and 2008. Table amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||
2009 | 2008 | % Change | ||||||||||
Marketing, General and Administrative: |
||||||||||||
Drew |
$ | 7,090 | $ | 5,287 | 34.1 | % | ||||||
Sonomed |
2,485 | 2,219 | 12.0 | % | ||||||||
EMI |
601 | 605 | -0.7 | % | ||||||||
Medical/Trek |
2,885 | 4,298 | -32.9 | % | ||||||||
Total |
$ | 13,061 | $ | 12,409 | 5.3 | % | ||||||
Consolidated marketing, general and administrative expenses from continuing operations
increased $652,000, or 5.3%, to $13,061,000 during the fiscal year ended June 30, 2009, as compared
to the fiscal year ended June 30, 2008.
Marketing, general and administrative expenses in the Drew business segment increased
$1,803,000, or 34.1%, to $7,090,000, as compared to the fiscal year ended June 30, 2008. The
increase was primarily due to the acquisitions of JAS on May 29, 2008 and certain assets of Biocode
on December 31, 2008 offset by significantly lower legal fees during the fiscal year ended June 30,
2009 and by reductions in force implemented in June 2008.
Marketing, general and administrative expenses in the Sonomed business segment increased by
$266,000, or 12.0%, to $2,485,000, as compared to the fiscal year ended June 30, 2008. The
increase was due primarily to the addition of a marketing consultant in the United States and the
addition of a consultant in South-east Asia and increased travel and advertising related to
marketing and trade show activity during the fiscal year ended June 30, 2009.
Marketing, general and administrative expenses in the EMI business segment decreased $4,000,
or .7%, to $601,000, as compared to the fiscal year ended June 30, 2008.
The Medical/Trek business units marketing, general and administrative expenses decreased
$1,413,000 or 32.9% to $2,885,000, as compared to the fiscal year ended June 30, 2008. The
decrease was due primarily to a reduction in force, lower compensation expense for directors,
decreased expenses for
23
third party consultants in valuation services, information technology and
accounting, and a reduction in legal fees.
The following table presents consolidated research and development expenses by reportable
business segment and as a percentage of related segment product revenues for the fiscal years ended
June 30, 2009 and 2008. Table amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||
2009 | 2008 | % Change | ||||||||||
Research and Development: |
||||||||||||
Drew |
$ | 1,800 | $ | 2,745 | -34.4 | % | ||||||
Sonomed |
1,085 | 779 | 39.3 | % | ||||||||
EMI |
362 | 268 | 35.1 | % | ||||||||
Medical/Trek |
9 | 6 | 50.0 | % | ||||||||
Total |
$ | 3,256 | $ | 3,798 | -14.3 | % | ||||||
Consolidated research and development expenses from continuing operations decreased $542,000,
or 14.3%, to $3,256,000 during the fiscal year ended June 30, 2009, as compared to the fiscal year
ended June 30, 2008. Research and development expenses were primarily expenses associated with the
planned introduction of new or enhanced products in the Drew, Sonomed and EMI business units.
Research and development expenses in the Drew business segment decreased $945,000, or 34.4%,
to $1,800,000. The decrease is related to the decision made in June 2008 to drastically reduce
Drews research and development department and move to an outsourced research and development
model.
Research and development expenses in the Sonomed business segment increased $306,000 or 39.3%,
to $1,085,000 as compared to the fiscal year ended June 30, 2008. The increase is primarily due to
consulting expenses incurred during the year related to the development two new products, the VuMax
III, and the PacScan Plus. The PacScan Plus received FDA approval in September 2009. Additional
work on the VuMax III was suspended (see below and footnote 4 of the notes to the consolidated
financial statements for further discussion).
Research and development in the EMI business segment increased $94,000 or 35.1%, to $362,000,
as compared to the fiscal year ended June 30, 2008. The increase was primarily due to higher
expenses during the fiscal year ended June 30, 2009 related to the development of the new Axis
product.
Gain on sale of assets was approximately $92,000 and $0 during the fiscal years ended June 30,
2009 and 2008, respectively due to the sale of assets at Drew related to Drews decision to
outsource future machine shop operations.
The Company recognized a loss of approximately $65,000 and $88,000 related to its investment
in OTM during the fiscal years ended June 30, 2009 and 2008, respectively. Commencing July 1,
2005, the Company began recognizing all of the losses of OTM in its consolidated financial
statements. OTM is an early stage privately held company. Prior to July 1, 2005, the share of
OTMs loss recognized by the Company was in direct proportion to the Companys ownership equity in
OTM. OTM began operations during the three-month period ended September 30, 2004. (See note 16 of
the notes to Consolidated Financial Statements.)
Interest income was $19,000 and $299,000 for the fiscal years ended June 30, 2009 and 2008,
respectively. The decrease was due to lower cash balances and effective yields on investments.
24
Interest expense was $216,000 and $12,000 for the fiscal years ended June 30, 2009 and 2008,
respectively. The increase was related to increased debt related to the JAS and Biocode
acquisitions.
Goodwill Impairment-Sonomed
During the last six months of fiscal year 2009 Sonomed experienced a significant decrease in
demand for its product offerings. The Company believes that this decrease in volume is related to
the global economic downturn and the effect it has had on the ability of Sonomeds traditional
customer base to add additional or upgraded capital equipment at this time. These troubling
economic conditions have also lead to increased sales discounts to Sonomeds distributors in order
to entice end users to purchase or to compete with toughening competition. These uncertainties in
the market along with increased competition from existing competitors and emerging technologies has
made it difficult for Sonomed to project future revenue and cash flow. The effect these conditions
had on fiscal 2009s actual performance as compared to budgeted performance was significant with
actual profitability approximately 65% lower than anticipated. The Company believes that these
negative sales and profitability trends will continue for the foreseeable future and thus will have
a significant negative affect on Sonomeds estimated future operating results and cash flow.
Sonomed reduced its work force by 13% during the fourth quarter of the year ended June 30, 2009 in
response to these uncertainties. Sonomed projected that these events will negatively affect the
evaluation of the future operating results and cash flows of Sonomed.
The Company tests goodwill for possible impairment on an annual basis and at any other time
events occur or circumstances indicate that the carrying amount of goodwill may be impaired.
The first step of the SFAS No. 142 impairment analysis consists of a comparison of the fair
value of the reporting segment with its carrying amount, including the goodwill. The fair value was
determined based on the income approach, which estimates the fair value based on the future
discounted cash flows. Under the income approach, the Company assumed, with respect to Sonomed, a
forecasted cash flow period of five years, long-term annual growth rates of 3% and a discount rate
of 19%.
Based on the annual income approach analysis that was separately performed for each operating
segment, it was determined that in the Sonomed segment the carrying amount of the goodwill was in
excess of its respective fair value. As such, the Company was required to perform the second step
analysis for Sonomed in order to determine the amount of the goodwill impairment. The second step
analysis consisted of comparing the implied fair value of the goodwill with the carrying amount of
the goodwill, with an impairment charge resulting from any excess of the carrying value of the
goodwill over the implied fair value of the goodwill. Based on the second step analysis, the
Company concluded that all $9,526,000 of the goodwill recorded at Sonomed was impaired. As a
result, the Company recorded a non-cash goodwill impairment charge to operations totaling
$9,526,000 for the year ended June 30, 2009.
The determination as to whether a write-down of goodwill is necessary involves significant
judgment based on short-term and long-term projections of the Company. The assumptions supporting
the estimated future cash flows of the reporting segment, including profit margins, long-term
forecasts, discount rates and terminal growth rates, reflect the Companys best estimates.
Goodwill Impairment-Drew
Drew encountered a series of events during the third and fourth quarters of the fiscal year
ended June 30, 2008 that had a material effect on the valuation of our goodwill related to the
purchase of Drew. These events include a development delay of Drews DS-360 instrument that Drew
had previously anticipated would be completed by the fourth quarter of the fiscal year ending June
30, 2008, and a contract dispute with Point Care Technologies (PCT) that has delayed the
development of Drews 2280 HT HIV instrument (see footnote 8 Commitments and Contingencies in the
notes to the financial statements in the Companys Form 10-K annual report for the fiscal year
ended June 30, 2008).
The development of Drews proposed new diabetes instrument, the DS-360, is indefinitely
delayed because of difficulties related to the final phase of its development. The DS-360 is
intended as Drews next
25
generation diabetes instrument, which is a key line of business for Drew.
The uncertainty of the DS-360s completion combined with the continued aging of Drews existing
diabetes instrument offerings has had a negative impact on Drews estimated future operating
results and cash flow. Drew, in consultation with independent consultants, continues to evaluate
the development status of the DS-360 project. Until the evaluation is completed, Drew cannot
estimate the timing of the 510(k) application submission for the instrument to the FDA or whether
the submission will be made.
Also, Drew had anticipated that the joint development project it had undertaken with PCT of
Drews 2280 HT HIV instrument would be completed during the fiscal year ended June 30, 2008. In
December 2008 Drew settled a contract dispute with PCT relating to this project (see footnote 8
Commitments and Contingencies in the Companys Form 10-K annual report for the fiscal year ended
June 30, 2008 for details on the dispute). As part of the settlement, dated November 3, 2008 Drew
and PCT are no longer jointly developing the 2280 HT HIV instrument, and Drew is unable to estimate
when or if the 2280 HT HIV instrument will be completed. Drew undertook the development effort at
considerable cost because it believed that the 2280 HT HIV instrument had significant potential in
monitoring the status of HIV patients. The uncertainty whether the 2280 HT HIV will be completed
has had a negative impact on Drews estimated future operating results and cash flow.
Because of these developments and the continued diminished operating results of Drews aging
legacy projects, the Company reduced its work force during the fourth quarter of the year ended
June 30, 2008 by 23 positions and restructured certain management responsibilities. These events
negatively affected the evaluation by the Company of the future operating results and cash flows of
Drew.
The Company tests goodwill for possible impairment on an annual basis and at any other time
events occur or circumstances indicate that the carrying amount of goodwill may be impaired.
The first step of the SFAS No. 142 impairment analysis consists of a comparison of the fair
value of the reporting segment with its carrying amount, including the goodwill. The fair value was
determined based on the income approach, which estimates the fair value based on the future
discounted cash flows. Under the income approach, the Company assumed, with respect to Drew, a
forecasted cash flow period of five years, long-term annual growth rates of 5% and a discount rate
of 14%.
Based on the annual income approach analysis that was separately performed for each operating
segment, it was determined that in the Drew segment the carrying amount of the goodwill was in
excess of its respective fair value. As such, the Company was required to perform the second step
analysis for Drew in order to determine the amount of the goodwill impairment. The second step
analysis consisted of comparing the implied fair value of the goodwill with the carrying amount of
the goodwill, with an impairment charge resulting from any excess of the carrying value of the
goodwill over the implied fair value of the goodwill. Based on the second step analysis, the
Company concluded that all $9,574,655 of the
goodwill recorded at Drew was impaired. As a result, the Company recorded a non-cash goodwill
impairment charge to operations totaling $9,574,655 for the year ended June 30, 2008.
The determination as to whether a write-down of goodwill is necessary involves significant
judgment based on short-term and long-term projections of the Company. The assumptions supporting
the estimated future cash flows of the reporting segment, including profit margins, long-term
forecasts, discount rates and terminal growth rates, reflect the Companys best estimates.
26
Liquidity and Capital Resources
The following table presents overall liquidity and capital resources as of June 30, 2010 and
2009. Table amounts are in thousands:
June 30, | ||||||||
2010 | 2009 | |||||||
Current Ratio: |
||||||||
Current assets |
$ | 16,748 | $ | 17,561 | ||||
Less: Current liabilities |
5,998 | 6,848 | ||||||
Working capital |
$ | 10,750 | $ | 10,713 | ||||
Current ratio |
2.8 to 1 | 2.6 to 1 | ||||||
Debt to Total Capital Ratio: |
||||||||
Notes payable and current maturities |
$ | 1,254 | $ | 1,375 | ||||
Long-term debt |
2,916 | 4,741 | ||||||
Total debt |
4,170 | 6,116 | ||||||
Total equity |
12,065 | 12,439 | ||||||
Total capital |
$ | 16,235 | $ | 18,555 | ||||
Total debt to total capital |
25.7 | % | 33.0 | % | ||||
Working Capital Position
Working capital increased $37,000 as of June 30, 2010, and the current ratio increased to 2.8
to 1 from 2.6 to 1 when compared to June 30, 2009. The increase in working capital was caused
primarily by an increase in cash of $1,532,000 to $3,342,000 in 2010 from $1,810,000 in 2009.
Accounts receivable decreased by $373,000, to $4,481,000 in 2010 from $4,854,000 in 2009, Net
inventory decreased $2,852,000 to $6,979,000 in 2010 from $9,831,000 in 2009, and discontinued
operations provided $290,000 in 2010. Overall total current assets decreased $813,000 to $16,748,000 in 2010 from
$17,561,000 in 2009. Total current liabilities, which consist of current portion of long term
debt, accounts payable and accrued expenses, decreased $850,000, to $5,998,000 in 2010 from
$6,848,000 in 2009. The decrease in current liabilities was due principally to a decrease in
accounts payable of $1,016,000 to $1,538,000 in 2010 from $2,554,000 in 2009.
Debt to Total Capital Ratio improved to 25.7% in 2010 from 33.0% in 2009 as a result of the
long-term debt payments paid by the Company in 2010.
Cash Used In or Provided By Operating Activities
During fiscal 2010, the Company used approximately $468,000 of cash for operating activities
as compared to using approximately $1,688,000 for operating activities during the year ended June
30, 2009.
During fiscal 2009, the Company used approximately $1,688,000 of cash for operating activities
as compared to using approximately $2,936,000 for operating activities during the year ended June
30,
27
2008. The net loss for 2009 and 2008 includes a non-cash goodwill impairment charge in the
amount of $9,526,000 and $9,575,000, respectively.
Cash Flows Used In Investing and Financing Activities
Cash flows provided from investing activities for 2010 were approximately $4,108,000. This
increase is due to net cash from the sale of Vascular of $4,338,000, which is offset by purchases
of fixed assets of $190,000 and investment in OTM of $39,000.
Cash flows used in investing activities for 2009 were approximately $489,000. This amount is
made up of purchases of fixed assets of $218,000, investment in OTM of $42,000, and the purchase of
certain assets of Biocode in the amount of $324,000 and offset by the collection on a note
receivable of $100,000.
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 in the amount of $1,177,000 during 2010 relate to
repayment of debt.
Cash flows provided by financing activities in the amount of $527,000 during 2009 relate to
repayment of debt of $502,000, and offset by the proceeds of $1,029,000 from the issuance of common
stock.
The Company is implementing an austerity plan to stem the recurring losses at Drew. If the
Company is unable to achieve improvement in this area in the near term, it is not likely that our
existing cash and cash flow from operations will be sufficient to fund activities throughout the
next 12 months without curtailing certain business activities. The Companys 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.
If the Company seeks to raise raising 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 be absent such
qualification. The sale of additional equity and debt securities may result in additional dilution
to the Companys shareholders. Additional financing may not be available in amounts or on terms
acceptable to us or at all.
Debt History
On December 31, 2008 Drew acquired certain assets of Biocode for $5,900,000 (4,200,000 Euros)
plus acquisition costs of approximately $300,000. The sales price was payable in cash of
approximately $324,000 (approximately 231,000 Euros) and $5,865,000 in debt from Drew. The
seller-provided financing is collateralized by certain assets of Biocode. Biocode assets were
vertically integrated into the Companys clinical diagnostics business that includes Drew and JAS.
The seller-provided financing, which is guaranteed by the Company, requires payment over four years
as follows:
| the first interest-only payment was due in December 2009 at an annual interest rate of 7%; this payment was paid on June 30, 2010 pursuant to an agreement reached with the seller; | ||
| thereafter, every nine months after June 30, 2010, an interest payment is due at an annual interest rate of 7%; | ||
| June 30, 2010 the principal payment of Euro 800,000 was made; | ||
| June 30, 2011 a principal payment of Euro 1,000,000 is due; |
28
| December 31, 2011 a principal payment of Euro 1,000,000 is due; and | ||
| December 31, 2012 a principal payment of Euro 1,375,000 is due. |
The payment amount in United States Dollars will be determined on the payment due date, based
upon the then current exchange rate between the United States Dollar and the Euro.
On May 29, 2008 Drew issued a note payable in the amount of $752,623 related to the purchase
of JAS. The note is collateralized by JASs common stock. Principal was payable in six quarterly
installments of $124,437 plus interest at the prime rate as published by the Bank of America. On
August 30, 2009 one of the notes related to the JAS acquisition was renegotiated. The amount
outstanding on August 30, 2009 was $178,370; this amount will be repaid in 12 equal installments of
$14,864 plus interest at 7%. The remaining balance of this debt as of June 30, 2010 is $33,692.
Off-Balance Sheet Arrangements and Contractual Obligations
The Company was not a party to any off-balance sheet arrangements as of and for the fiscal
years ended June 30, 2010 and 2009. The following table presents the Companys contractual
obligations as of June 30, 2010 (interest is not included in the table as it is not material):
Less than | 3-5 | More than | ||||||||||||||||||
Total | 1 Year | 1-3 Years | Years | 5 Years | ||||||||||||||||
Long-term debt |
$ | 4,170,738 | $ | 1,254,492 | $ | 2,916,246 | $ | 0 | $ | 0 | ||||||||||
Operating lease agreements |
4,464,925 | 862,654 | 1,657,158 | 1,153,944 | 791,169 | |||||||||||||||
Total |
$ | 8,635,663 | $ | 2,117,146 | $ | 4,573,404 | $ | 1,153,944 | $ | 791,169 | ||||||||||
Forward-Looking Statement About Significant Items Likely To Impact Liquidity
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. The Company has incurred recurring operating losses and negative cash
flows from operating activities. These conditions raise substantial doubt about the Companys
ability to continue as a going concern. The financial statements for the fiscal year ended June 30,
2010 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 we be unable to
continue as a going concern. The Companys continuance as a going concern is dependent on our
future profitability and on the on-going support of the Companys shareholders, affiliates and
creditors. In order to mitigate the going concern issues, the Company is actively pursuing business
partnerships, managing the Companys continuing operations, and seeking capital funding on an
ongoing basis via the issuance of securities and private placements. If the Company is unsuccessful
in its efforts to raise additional capital in the near term, the Company may be required to
significantly reduce its research, development, and administrative activities, including further
reduction of its employee base.
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
29
transactions, the Companys financial results may differ from the investment
communitys 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 Companys
combined businesses or product lines to realize the value from any expected synergies. Depending on
the size and complexity of an acquisition, the Companys 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 Companys attention from other business operations.
The Company has incurred recurring operating losses and negative cash flows from operating
activities related to its Drew division which includes the recently acquired Biocode. The Company
is experiencing lower than expected sales from Biocode related to reduced instrument sales due to
uncertainty surrounding pending regulatory changes under French law. The Company does not know when
this uncertainty will be resolved nor what impact the new law if enacted will have on Biocodes
revenues in the future. For the year ended June 30, 2010, Biocode generated a net loss from
operations of $636,000. Also, since its acquisition of Drew the Company loaned approximately $29
million to Drew, and during fiscal year ended June 30, 2010 invested additional capital in Biocode
of approximately $1,200,000. The funds were primarily used to procure components to build up
inventory to support the manufacturing process, to pay off accounts payable and debt of Drew, and
to expand the sales and marketing and research and development efforts, to fund new product
development and underwrite operating losses since its acquisition. The Company cannot rule out that
further working capital will be required by Drew and Biocode. If the Company does not realize the
expected benefits or synergies of such transactions, the Companys consolidated financial position,
results of operations and stock price could be negatively impacted. Also, the Companys 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 Companys
growth.
Common Stock
The Companys common stock is currently listed on the NASDAQ Capital Market. In order to
continue to be listed on the NASDAQ Capital Market, the following requirements must be met:
| Shareholders equity of $2,500,000 or market value of listed securities of $35,000,000 or net income from continuing operations (in the latest fiscal year or two of the last three fiscal years) of $500,000; | ||
| 500,000 publicly held shares; | ||
| $1,000,000 market value of publicly held shares; | ||
| A minimum bid price of $1; | ||
| 300 round lot shareholders; | ||
| Two market makers; and | ||
| Compliance with corporate governance standards. |
As of June 30, 2010, the Company was in compliance with these continued listing requirements.
Critical Accounting Policies
The preparation of financial statements requires management to make estimates and assumptions
that impact amounts reported therein. The most significant of those involve the application of
FASB issued authoritative guidance concerning Revenue Recognition, Goodwill and Other Intangible
Assets, discussed further in the notes to consolidated financial statements included in this Form
10-K. The financial statements are prepared in conformity with accounting principles generally
accepted in the United States of
30
America, and, as such, include amounts based on informed estimates
and judgments of management. For example, estimates are used in determining valuation allowances
for deferred income taxes, uncollectible receivables, obsolete inventory, sales returns and rebates
warranty liabilities and purchased intangible assets. 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.
Revenue Recognition
The Company recognizes revenue from the sale of its products at the time of shipment, when
title and risk of loss transfer. The Company provides products to its distributors at agreed
wholesale prices and to the balance of its customers at set retail prices. Distributors can
receive discounts for accepting high volume shipments. The discounts are reflected immediately in
the net invoice price, which is the basis for revenue recognition. No further material discounts
are given.
The Companys considerations for recognizing revenue upon shipment of product to a distributor
are based on the following:
| Persuasive evidence that an arrangement (purchase order and sales invoice) exists between a willing buyer (distributor) and the Company that outlines the terms of the sale (company information, quantity of goods, purchase price and payment terms). The buyer (distributor) does not have a right of return. | ||
| Shipping terms are ex-factory shipping point. At this point the buyer (distributor) takes title to the goods and is responsible for all risks and rewards of ownership, including insuring the goods as necessary. | ||
| The Companys price to the buyer (distributor) is fixed and determinable as specifically outlined on the sales invoice. The sales arrangement does not have customer cancellation or termination clauses. | ||
| The buyer (distributor) places a purchase order with the Company; the terms of the sale are cash, COD or credit. Customer credit is determined based on the Companys policies and procedures related to the buyers (distributors) creditworthiness. Based on this determination, the Company believes that collectibility is reasonably assured. |
The Company assesses collectibility based on creditworthiness of the customer and past
transaction history. The Company performs ongoing credit evaluations of its customers and does not
require collateral from its customers. For many of the Companys international customers, the
Company requires an irrevocable letter of credit to be issued by the customer before the purchase
order is accepted.
Valuation of Intangible Assets
The Company annually evaluates for impairment its intangible assets and goodwill in accordance
with SFAS 142, Goodwill and Other Intangible Assets, or whenever events or changes in
circumstances indicate that the carrying value may not be recoverable, see footnote 4 to
consolidated financial statements included in this Form 10-K for details on a goodwill impairment
charge related to the carrying amount of Sonomed and Drews goodwill. These intangible assets
include goodwill, trademarks and trade names. Factors the Company considers important that could
trigger an impairment review include significant under-performance relative to historical or
projected future operating results or significant negative industry or economic trends. If these
criteria indicate that the value of the intangible asset may be impaired, an evaluation of the
recoverability of the net carrying value of the asset is made. If this evaluation indicates that
the intangible asset is not recoverable, the net carrying value of the related intangible asset
will be reduced to fair value. Any such impairment charge could be significant and could have a
material adverse impact on the Companys financial statements if and when an impairment charge is
recorded.
31
Income/(Loss) Per Share
The Company computes net income/(loss) per share under the provisions of FASB issued
authoritative guidance.
Under the provisions of FASB issued authoritative guidance, basic and diluted net
income/(loss) per share is computed by dividing the net income/(loss) for the period by the
weighted average number of shares of common stock outstanding during the period. The calculation
of diluted net income/(loss) per share excludes potential common shares if the impact is
anti-dilutive. Basic earnings per share are computed by dividing net income/(loss) by the weighted
average number of shares of common stock outstanding during the period. Diluted earnings per share
are determined in the same manner as basic earnings per share, except that the number of shares is
increased by assuming exercise of dilutive stock options and warrants using the treasury stock
method.
Taxes
Estimates of taxable income of the various legal entities and jurisdictions are used in the
tax rate calculation. Management uses judgment in estimating what the Companys income will be for
the year. Since judgment is involved, there is a risk that the tax rate may significantly increase
or decrease in any period.
In determining income/(loss) for financial statement purposes, management must make certain
estimates and judgments. These estimates and judgments occur in the calculation of certain tax
liabilities and in the determination of the recoverability of certain deferred tax assets, which
arise from temporary differences between the tax and financial statement recognition of revenue and
expense. FASB issued authoritative guidance concerning accounting for income taxes also requires
that the deferred tax assets be reduced by a valuation allowance, if based on the available
evidence, it is more likely that not that all or some portion of the recorded deferred tax assets
will not be realized in future periods.
In evaluating the Companys ability to recover the Companys deferred tax assets, management
considers all available positive and negative evidence including the Companys past operating
results, the existence of cumulative losses and near-term forecasts of future taxable income that
is consistent with the plans and estimates management is using to manage the underlying businesses.
Through June 30, 2010, the Company has recorded a valuation allowance against the Companys
net operating losses for substantially all of the deferred tax asset due to uncertainty of their
realization as a result of the Companys earnings history, the number of years the Companys net
operating losses and tax
credits can be carried forward, the existence of taxable temporary differences and near-term
earnings expectations. The amount of the valuation allowance could decrease if facts and
circumstances change that materially increase taxable income prior to the expiration of the loss
carryforwards. Any reduction would reduce (increase) the income tax expense (benefit) in the
period such determination is made by the Company.
The Company has adopted FASB issued guidance related to accounting for uncertainty in income
taxes, which provides a comprehensive model for the recognition, measurement, and disclosure in
financial statements of uncertain income tax positions that a company has taken or expects to take
on a tax return. Under the FASB guidance a company can recognize the benefit of an income tax
position only if it is more likely than not (greater than 50%) that the tax position will be
sustained upon tax examination, based solely on the technical merits of the tax position.
Otherwise, no benefit can be recognized. The tax benefits recognized are measured based on the
largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement.
Additionally, companies are required to accrue interest and related penalties, if applicable, on
all tax exposures for which reserves have been established consistent with jurisdictional tax laws.
The Company has elected to recognize interest expense and penalties related to uncertain tax
positions as a component of its provision for income taxes.
32
Stock-Based Compensation
Effective July 1, 2007, the Company adopted the FASB issued authoritative guidance on
share-based payments. SFAS 123(R) is a revision of SFAS No. 123 and supersedes ABP Opinion No.
25. The Company used the modified prospective transition method and therefore did not have to
restate results for prior periods. Under this transition method, stock-based compensation expense
for 2007 includes compensation expense for all stock-based compensation awards granted prior to,
but not yet vested as of, July 1, 2006, based on the grant date fair value estimate in accordance
with the original provisions of SFAS 123. Stock-based compensation expense for all stock-based
compensation awards granted after July 1, 2006 is based on the grant-date fair value estimate in
accordance with the provisions of SFAS 123(R). The Company will recognize these compensation costs
on a straight-line basis over the requisite service period of the award.
Valuations are based on highly subjective assumptions about the future, including stock
price volatility and exercise patterns. The fair value of share-based payment awards was estimated
using the Black-Scholes option pricing model. Expected volatilities are based on the historical
volatility of the Companys stock. The Company uses historical data to estimate option exercise and
employee terminations. The expected term of options granted represents the period of time that
options granted are expected to be outstanding. The risk-free rate for periods within the expected
life of the option is based on the U.S. Treasury yield curve in effect at the time of the grant.
Prior to the adoption of SFAS 123(R), the Company accounted for stock-based compensation
in accordance with APB No. 25.
Recently Issued Accounting Standards
In October 2009, the Financial Accounting Standards Board (FASB) issued
amended revenue recognition authoritative guidance for arrangements with multiple deliverables. The
new authoritative guidance eliminates the residual method of revenue recognition and allows the use
of managements best estimate of selling price for individual elements of an arrangement when
vendor specific objective evidence (VSOE), vendor objective evidence (VOE) or third-party
evidence (TPE) is unavailable. This guidance is effective for all new or materially modified
arrangements entered into on or after January 1, 2011, with earlier application permitted as of the
beginning of any prior fiscal year. Full retrospective application of the new guidance is optional.
The Company is currently assessing the impact that the implementation of this new guidance will
have on the Companys financial position and operations.
In October 2009, the FASB issued authoritative guidance that amends the scope of existing
software revenue recognition accounting. Tangible products containing software components and
non-software components that function together to deliver the products essential functionality
would be scoped out of the accounting guidance on software and accounted for based on other
appropriate revenue recognition guidance. This guidance is effective for all new or materially
modified arrangements entered into on or after January 1, 2011, with earlier application permitted
as of the beginning of any prior fiscal year. Full retrospective application of the new guidance is
optional. This guidance must be adopted in the same period that the Company adopts the amended
accounting for arrangements with multiple deliverables described in the preceding paragraph. The
Company is currently assessing the impact that the implementation of this new guidance will have on
the Companys financial position and operations.
On July 1, 2009, the FASB issued the FASB Accounting Standards Codification (the
Codification). The Codification became the single authoritative source of GAAP recognized by the
FASB. The Codification superseded all previously-existing non-Securities and Exchange Commission
accounting and reporting standards, and all other non-grandfathered non-Securities and Exchange
Commission accounting literature not included in the Codification became nonauthoritative. The
Codification was effective for interim and annual reporting periods ending after September 15,
2009. The Company adopted the Codification for the quarter ended September 30, 2009. The Companys
adoption of the Codification did not have any impact on the Companys financial position and
operations as this change is disclosure-only in nature.
In June 2009, the FASB issued authoritative guidance that amends the consolidation guidance
applicable to variable interest entities and requires enhanced disclosures intended to provide
users of
33
financial statements with more transparent information about an enterprises involvement
in a variable interest entity. This guidance will be effective beginning with the Companys
consolidated financial statements for the year ending June 30, 2011 and the quarterly periods
thereof. The Company does not expect the impact of adoption to be material on its financial
position and operations.
In June 2009, the FASB issued authoritative guidance that eliminates the concept of a
qualifying special-purpose entity, changes the requirements for derecognizing financial assets and
requires enhanced disclosure to provide financial statement users with greater transparency about
transfers of financial assets, including securitization transactions and an entitys continuing
involvement in and exposure to the risks
related to the transfer of financial assets. This guidance will be effective beginning with the
Companys consolidated financial statements for the year ending June 30, 2011 and the quarterly
periods thereof. The Company does not expect the impact of adoption to be material on its financial
position and operations.
In May 2009, the FASB issued amended authoritative guidance on subsequent event accounting
which sets forth: (i) the period after the balance sheet date during which management of a
reporting entity should evaluate events or transactions that may occur for potential recognition or
disclosure in the financial statements; (ii) the circumstances under which an entity should
recognize events or transactions occurring after the balance sheet date in its financial
statements; and (iii) the disclosures that an entity should make about events or transactions that
occurred after the balance sheet date. These guidelines were effective for interim and annual
periods ending after June 15, 2009, and the Company adopted them in the quarter ended June 30,
2009. The Company has evaluated subsequent events through
October 12, 2010, which is the date these
financial statements were issued.
ITEM 7A. QUANTITATIVE AND QUALIITATIVE DISCLOSURES ABOUT MARKET RISK
Market risk represents the risk of loss that may impact the Companys consolidated financial
position, results of operations or cash flows. In the normal course of doing business, the Company
is exposed to the risks associated with foreign currency exchange rates and changes in interest
rates.
Interest Rate Risk
The table provides information about the Companys financial instruments consisting of fixed
interest rate debt obligations. For debt obligations, the table represents principal cash flows
and related interest rates by expected maturity dates. (See note 6 of the notes to consolidated
financial statements for further information regarding the Companys debt obligations.)
Interest | ||||||||||||||||||||
Rate | 2011 | 2012 | 2013 | Total | ||||||||||||||||
Notes Payable Former JAS Shareholders |
7 | % | $ | 33,692 | $ | | $ | | $ | 33,692 | ||||||||||
Notes Payable Bio Code |
7 | % | $ | 1,220,800 | $ | 1,220,800 | $ | 1,695,446 | $ | 4,137,046 |
34
Currency Fluctuations
For the years ended June 30, 2010, 2009 and 2008, approximately 16.3%, 19.6% and 13.2%,
respectively, of the Companys net revenues were generated in currencies other than the United
States dollar. Fluctuations in the value of foreign currencies relative to the United States dollar
affect our reported results of operations. If the United States dollar weakens relative to the
foreign currency, then the Companys earnings generated in the foreign currency will, in effect,
increase when converted into United States dollars and vice versa. Exchange rate differences
resulting from the strength or weakness of the United States dollar against the Euro and the United
Kingdom Pound Sterling resulted in decreases of approximately $393,000, in net revenues in 2010
compared to 2009, increases of approximately $323,000, in net
revenues in 2009 compared to 2008.
During the three years ended June 30, 2010, no
subsidiary was domiciled in a highly inflationary environment and the impact of inflation and
changing prices on our net sales and revenues and on loss from continuing operations was not
material.
Conducting an international business inherently involves a number of difficulties, risks, and
uncertainties, such as export and trade restrictions, inconsistent and changing regulatory
requirements, tariffs and other trade barriers, cultural issues, longer payment cycles, problems in
collecting accounts receivable, political instability, local economic downturns, seasonal
reductions in business activity in Europe during the traditional summer vacation months, and
potentially adverse tax consequences.
The following table presents foreign revenue as a percentage of total revenue:
2010 | 2009 | 2008 | ||||||||||
Total |
$ | 16,186,116 | $ | 15,414,655 | $ | 12,661,554 | ||||||
Total Net Revenue |
$ | 31,641,579 | $ | 30,732,984 | $ | 26,091,615 | ||||||
Foreign revenue as a percent of total revenue |
51.2 | % | 50.2 | % | 48.5 | % |
35
ITEM 8. | FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA |
Escalon Medical Corp.
Index to Consolidated Financial Statements
Index to Consolidated Financial Statements
Page | ||||
Report of Independent Registered Public Accounting Firm |
37 | |||
Consolidated Balance Sheets at June 30, 2010 and 2009 |
38 | |||
Consolidated Statements of Operations for the Years Ended June 30, 2010, 2009 and 2008 |
39 | |||
Consolidated Statements of Shareholders Equity and Comprehensive Loss
for the Years Ended June 30, 2010, 2009 and 2008 |
40 | |||
Consolidated Statements of Cash Flows for the Years Ended June 30, 2010, 2009 and 2008 |
41 | |||
Notes to Consolidated Financial Statements |
42 |
36
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and
Shareholders of Escalon Medical Corp.
Shareholders of Escalon Medical Corp.
We have audited the accompanying consolidated balance sheets of Escalon Medical Corp. and
Subsidiaries as of June 30, 2010 and 2009, and the related consolidated statements of operations,
shareholders equity and comprehensive loss, and cash flows for each of the years in the three-year
period ended June 30, 2010. These financial statements are the responsibility of the companys
management. Our responsibility is to express an opinion on these financial statements based on our
audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement. The
company is not required to have, nor were we engaged to perform, an audit of its internal control
over financial reporting. Our audit included consideration of internal control over financial
reporting as a basis for designing audit procedures that are appropriate in the circumstances, but
not for the purpose of expressing an opinion on the effectiveness of the companys internal control
over financial reporting. Accordingly, we express no such opinion. An audit also includes
examining, on a test basis, evidence supporting the amounts and disclosures in the financial
statements, assessing the accounting principles used and significant estimates made by management,
as well as evaluating the overall financial statement presentation. We believe that our audits
provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all material
respects, the financial position of Escalon Medical Corp. and Subsidiaries as of June 30, 2010 and
2009, and the consolidated results of its operations and its cash flows for each of the years in
the three-year period ended June 30, 2010 in conformity with accounting principles generally
accepted in the United States of America.
The accompanying consolidated financial statements for the year ended June 30, 2010 have been
prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the
consolidated financial statements, the ongoing debt payments on the debt related to the Biocode
Hycel acquisition and continued losses from operations and negative cash flows from operating
activities raise substantial doubt about the Companys ability to continue as a going concern.
Managements plans concerning these matters are also described in Note 1 to the consolidated
financial statements. The consolidated financial statements do not include any adjustments that
might result from the outcome of this uncertainty.
/s/
Mayer Hoffman McCann P.C.
Plymouth Meeting, Pennsylvania
October 12, 2010
37
ESCALON MEDICAL CORP. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
June 30, | June 30, | |||||||
2010 | 2009 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 3,342,422 | $ | 1,810,045 | ||||
Accounts receivable, net |
4,481,249 | 4,853,856 | ||||||
Inventory, net |
6,978,714 | 9,830,922 | ||||||
Other current assets |
521,341 | 1,065,823 | ||||||
Assets of discontinued operations |
1,424,183 | | ||||||
Total current assets |
16,747,909 | 17,560,646 | ||||||
Furniture and equipment, net |
672,490 | 892,966 | ||||||
Goodwill |
1,124,018 | 2,065,236 | ||||||
Trademarks and trade names |
694,006 | 694,006 | ||||||
Patents, net |
1,284,109 | 1,824,172 | ||||||
Covenant not to compete and customer list, net |
1,480,264 | 1,880,639 | ||||||
Other assets |
4,140 | 137,737 | ||||||
Total assets |
$ | 22,006,936 | $ | 25,055,402 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Current portion of long-term debt |
$ | 1,254,492 | $ | 1,374,711 | ||||
Accounts payable |
1,537,860 | 2,553,481 | ||||||
Accrued expenses |
2,499,879 | 2,919,540 | ||||||
Liabilities of discontinued operations |
705,635 | 0 | ||||||
Total current liabilities |
5,997,866 | 6,847,732 | ||||||
Long-term debt, net of current portion |
2,916,246 | 4,741,207 | ||||||
Accrued post-retirement benefits |
1,027,821 | 1,027,821 | ||||||
Total long-term liabilities |
3,944,067 | 5,769,028 | ||||||
Total liabilities |
9,941,932 | 12,616,760 | ||||||
Shareholders equity: |
||||||||
Preferred stock, $0.001 par value; 2,000,000
shares authorized; no shares issued |
||||||||
Common stock, $0.001 par value; 35,000,000
share authorized; 7,526,430
issued and outstanding at June 30,
2010 and June 30, 2009 |
7,526 | 7,526 | ||||||
Common stock warrants |
1,733,460 | 1,733,460 | ||||||
Additional paid-in capital |
67,583,905 | 67,458,745 | ||||||
Accumulated deficit |
(56,646,366 | ) | (56,232,503 | ) | ||||
Accumulated other comprehensive loss |
(613,521 | ) | (528,586 | ) | ||||
Total shareholders equity |
12,065,004 | 12,438,642 | ||||||
Total liabilities and shareholders equity |
$ | 22,006,936 | $ | 25,055,402 | ||||
See notes to consolidated financial statements
38
ESCALON MEDICAL CORP. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
For the Years Ended June 30, | 2010 | 2009 | 2008 | |||||||||
Net revenues: |
||||||||||||
Product revenue |
$ | 30,656,518 | $ | 30,600,177 | $ | 25,869,540 | ||||||
Other revenue |
985,061 | 132,807 | 222,075 | |||||||||
Revenues, net |
31,641,579 | 30,732,984 | 26,091,615 | |||||||||
Costs and expenses: |
||||||||||||
Cost of goods sold |
17,442,816 | 18,097,777 | 15,771,685 | |||||||||
Marketing, general and administrative |
15,692,087 | 13,060,528 | 12,408,561 | |||||||||
Research and development |
1,893,182 | 3,255,634 | 3,798,374 | |||||||||
Goodwill impairment |
0 | 9,525,550 | 9,574,655 | |||||||||
Total costs and expenses |
35,028,085 | 43,939,489 | 41,553,275 | |||||||||
Income (loss) from operations |
(3,386,506 | ) | (13,206,505 | ) | (15,461,660 | ) | ||||||
Other (expense) income |
||||||||||||
Gain on sale of assets |
0 | 91,871 | 0 | |||||||||
Equity in Ocular Telehealth Management, LLC |
(74,911 | ) | (65,387 | ) | (88,206 | ) | ||||||
Interest income |
285 | 18,562 | 299,538 | |||||||||
Interest expense |
(427,083 | ) | (216,274 | ) | (11,827 | ) | ||||||
Total other income (expense) |
(501,709 | ) | (171,228 | ) | 199,505 | |||||||
Net loss from continuing operations before
taxes |
(3,888,215 | ) | (13,377,733 | ) | (15,262,155 | ) | ||||||
Provision for income taxes |
0 | 0 | 134,990 | |||||||||
Net income (loss) from continuing operations |
(3,888,215 | ) | (13,377,733 | ) | (15,397,145 | ) | ||||||
Net income from discontinued operations,
including gain on disposal of $3,493,311 during 2010 |
3,474,351 | 412,697 | 337,502 | |||||||||
Net loss |
$ | (413,864 | ) | $ | (12,965,036 | ) | $ | (15,059,643 | ) | |||
Net income (loss) per share |
||||||||||||
Basic: |
||||||||||||
Continuing operations |
$ | (0.52 | ) | $ | (1.87 | ) | $ | (2.41 | ) | |||
Discontinued operations |
0.46 | 0.06 | 0.05 | |||||||||
Net income (loss) |
$ | (0.06 | ) | $ | (1.81 | ) | $ | (2.36 | ) | |||
Diluted: |
||||||||||||
Continuing operations |
$ | (0.52 | ) | $ | (1.87 | ) | $ | (2.41 | ) | |||
Discontinued operations |
0.46 | 0.06 | 0.05 | |||||||||
Net income (loss) |
$ | (0.06 | ) | $ | (1.81 | ) | $ | (2.36 | ) | |||
Weighted average shares basic |
7,526,430 | 7,137,541 | 6,389,008 | |||||||||
Weighted average shares diluted |
7,526,430 | 7,137,541 | 6,389,008 | |||||||||
See notes to the consolidated financial statements
39
ESCALON
MEDICAL CORP AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF SHAREHOLDERS EQUITY
AND COMPREHENSIVE LOSS FOR THE YEARS ENDED
JUNE 30, 2010, 2009 and 2008
CONSOLIDATED STATEMENTS OF SHAREHOLDERS EQUITY
AND COMPREHENSIVE LOSS FOR THE YEARS ENDED
JUNE 30, 2010, 2009 and 2008
Accumulated | ||||||||||||||||||||||||||||
Common | Additional | Other | Total | |||||||||||||||||||||||||
Common Stock | Stock | Paid-in | Accumulated | Comprehensive | Shareholders | |||||||||||||||||||||||
Shares | Amount | Warrants | Capital | Deficit | Income (Loss) | Equity | ||||||||||||||||||||||
BALANCE AT JUNE 30, 2007 |
6,499,357 | $ | 6,499 | $ | 1,601,346 | $ | 66,044,938 | $ | (28,207,824 | ) | $ | (39,353 | ) | $ | 39,405,606 | |||||||||||||
Comprehensive Income (Loss): |
||||||||||||||||||||||||||||
Net loss |
0 | 0 | 0 | 0 | (15,059,643 | ) | 0 | (15,059,643 | ) | |||||||||||||||||||
Foreign currency translation |
0 | 0 | 0 | 0 | 0 | (67,710 | ) | (67,710 | ) | |||||||||||||||||||
Total comprehensive income(loss) |
0 | 0 | 0 | 0 | (15,059,643 | ) | (67,710 | ) | (15,127,353 | ) | ||||||||||||||||||
Exercise of stock options |
27,073 | 27 | 0 | 7,435 | 0 | 0 | 7,462 | |||||||||||||||||||||
Compensation expense |
0 | 0 | 0 | 246,757 | 0 | 0 | 246,757 | |||||||||||||||||||||
BALANCE AT JUNE 30, 2008 |
6,526,430 | 6,526 | 1,601,346 | 66,299,130 | (43,267,467 | ) | (107,063 | ) | 24,532,472 | |||||||||||||||||||
Issuance of common stock |
1,000,000 | 1,000 | 0 | 895,886 | 0 | 0 | 896,886 | |||||||||||||||||||||
Issuance of warrants |
0 | 0 | 132,114 | 0 | 0 | 0 | 132,114 | |||||||||||||||||||||
Comprehensive Income (loss): |
||||||||||||||||||||||||||||
Net loss |
0 | 0 | 0 | 0 | (12,965,036 | ) | 0 | (12,965,036 | ) | |||||||||||||||||||
Foreign currency translation |
0 | 0 | 0 | 0 | 0 | (421,523 | ) | (421,523 | ) | |||||||||||||||||||
Total comprehensive income (loss) |
(12,965,036 | ) | (421,523 | ) | (13,386,559 | ) | ||||||||||||||||||||||
Compensation expense |
0 | 0 | 0 | 263,729 | 0 | 0 | 263,729 | |||||||||||||||||||||
BALANCE AT JUNE 30, 2009 |
7,526,430 | 7,526 | 1,733,460 | 67,458,745 | (56,232,503 | ) | (528,586 | ) | 12,438,642 | |||||||||||||||||||
Comprehensive Income (loss): |
||||||||||||||||||||||||||||
Net loss |
0 | 0 | 0 | 0 | (413,864 | ) | 0 | (413,864 | ) | |||||||||||||||||||
Foreign currency translation |
0 | 0 | 0 | 0 | 0 | (84,935 | ) | (84,935 | ) | |||||||||||||||||||
Total comprehensive income (loss) |
0 | 0 | 0 | 0 | (413,864 | ) | (84,935 | ) | (498,798 | ) | ||||||||||||||||||
Compensation expense |
125,160 | 125,160 | ||||||||||||||||||||||||||
BALANCE AT JUNE 30, 2010 |
7,526,430 | $ | 7,526 | $ | 1,733,460 | $ | 67,583,905 | $ | (56,646,366 | ) | $ | (613,521 | ) | $ | 12,065,004 | |||||||||||||
See notes to consolidated financial statements
40
ESCALON MEDICAL CORP. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
Years Ended June 30, | 2010 | 2009 | 2008 | |||||||||
Cash Flows from Operating Activities: |
||||||||||||
Net (loss) before discontinued operations |
$ | (3,888,215 | ) | $ | (13,377,733 | ) | $ | (15,397,145 | ) | |||
Adjustments
to reconcile net (loss) before discontinued
operations to net cash (used in) operating activities: |
||||||||||||
Depreciation and amortization |
1,147,050 | 742,460 | 535,059 | |||||||||
Goodwill Impairment |
| 9,525,550 | 9,574,655 | |||||||||
Compensation expense related to stock options |
125,160 | 263,729 | 246,757 | |||||||||
Change in accrued post-retirement benefits |
| (59,179 | ) | | ||||||||
Gain on sale of assets |
| (91,871 | ) | 28,421 | ||||||||
Loss of Ocular Telehealth Management, LLC |
74,911 | 65,387 | 88,206 | |||||||||
Change in operating assets and liabilities: |
||||||||||||
Accounts receivable, net |
12,246 | 123,220 | 1,006,811 | |||||||||
Inventory, net |
2,394,907 | 1,044,131 | (555,939 | ) | ||||||||
Other current and long-term assets |
672,610 | (727,306 | ) | 207,680 | ||||||||
Accounts payable, accrued and other liabilities |
(1,296,456 | ) | 177,109 | 1,204,368 | ||||||||
Net cash (used in) operating activities from continuing
operations |
(757,787 | ) | (2,314,503 | ) | (3,061,127 | ) | ||||||
Net cash provided by operating activities from
discontinued operations |
290,029 | 626,167 | 124,636 | |||||||||
Net cash (used in) operating activities |
(467,758 | ) | (1,688,336 | ) | (2,936,491 | ) | ||||||
Cash Flows from Investing Activities: |
||||||||||||
Collection on note receivable |
| 100,000 | | |||||||||
Investment in Ocular Telehealth Management, LLC |
(39,400 | ) | (42,000 | ) | (69,000 | ) | ||||||
Purchase of fixed assets |
(190,351 | ) | (217,834 | ) | (536,506 | ) | ||||||
Purchase of Biocode Hycel France, S.A. |
| (323,975 | ) | | ||||||||
Purchase of JAS Diagnostics, net of cash acquired |
| | (1,324,706 | ) | ||||||||
Net cash (used in) investing activities from continuing
operations |
(229,751 | ) | (483,809 | ) | (1,930,212 | ) | ||||||
Net cash (used in)/provided by investing activities from
discontinued operations
inlcuding proceeds from sale of vascular assets |
4,337,680 | (5,352 | ) | (76,652 | ) | |||||||
Net cash (used in)/provided by investing activities |
4,107,929 | (489,161 | ) | (2,006,864 | ) | |||||||
Cash Flows from Financing Activities: |
||||||||||||
Principal payments on long-term debt |
(1,176,980 | ) | (501,745 | ) | (150,200 | ) | ||||||
Issuance of common stock private placement |
| 1,029,000 | | |||||||||
Issuance of common stock stock options |
| | 7,462 | |||||||||
Net cash provided by/(used in) financing activities |
(1,176,980 | ) | 527,255 | (142,738 | ) | |||||||
Effect of exchange rate changes on cash & cash equivalents |
(930,815 | ) | (248,170 | ) | (84,913 | ) | ||||||
Net increase (decrease) in cash and cash equivalents |
1,532,377 | (1,898,412 | ) | (5,171,006 | ) | |||||||
Cash and cash equivalents, beginning of period |
1,810,045 | 3,708,456 | 8,879,462 | |||||||||
Cash and cash equivalents, end of period |
$ | 3,342,422 | $ | 1,810,045 | $ | 3,708,456 | ||||||
Interest paid |
$ | 618,032 | $ | 25,325 | $ | 11,827 | ||||||
Income taxes refund (paid) |
$ | 0 | $ | 0 | $ | (114,174 | ) | |||||
Issuance of long-term debt for JAS acquisition |
$ | 0 | $ | 752,623 | ||||||||
Sale of Equipment |
||||||||||||
Note receivable for equipment |
$ | 100,000 | ||||||||||
Net book value of equipment sold |
(8,129 | ) | ||||||||||
Gain of sale of equipment |
(91,871 | ) | ||||||||||
Cash received for equipment |
$ | | ||||||||||
Acquistion of Bio Code Hycel France, S.A. |
||||||||||||
Working capital other than cash |
$ | 3,944,102 | ||||||||||
Fixed assets |
50,442 | |||||||||||
Intangibles and other assets |
2,194,471 | |||||||||||
Long term debt |
(5,865,040 | ) | ||||||||||
Cash paid to acquire Biocode-Hycel France S.A |
$ | 323,975 | ||||||||||
See notes to consolidated financial statements
41
Escalon Medical Corp. and Subsidiaries
Notes to Consolidated Financial Statements
1. Going Concern
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. Escalon Medical Corp. (Escalon or the Company) has incurred
recurring operating losses and negative cash flows from operating activities and the debt payments
related to the Biocode acquisition commenced in the current year. These conditions raise
substantial doubt about the Companys ability to continue as a going concern. If the Company is
unsuccessful in its efforts to raise additional capital in the near term, the Company may be
required to significantly reduce its research, development, and administrative activities,
including further reduction of its employee base. The 2010 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 we be unable to continue as a going
concern. Our continuance as a going concern is dependent on our future profitability and on the
on-going support of our shareholders, affiliates and creditors. In order to mitigate the going
concern issues, we are actively pursuing business partnerships, managing our continuing operations,
and seeking capital funding on an ongoing basis via the issuance of securities and private
placements.
The Company is implementing an austerity plan to stem the recurring losses at Drew. If the
Company is unable to achieve improvement in this area in the near term, it is not likely that our
existing cash and cash flow from operations will be sufficient to fund activities throughout the
next 12 months without curtailing certain business activities. The Companys 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.
If the Company seeks to raise 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 my 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 Companys
shareholders. Additional financing may not be available in amounts or on terms acceptable to the
Company or at all.
2. Organization and Description of Business and Business Conditions
The 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 and its wholly owned subsidiaries: Sonomed, Inc. (Sonomed), Escalon Vascular
Access, Inc. (Vascular), Escalon Medical Europe GmbH (EME), Escalon Digital Vision, Inc.
(EMI), Escalon Pharmaceutical, Inc. (Pharmaceutical), Escalon Holdings, Inc. (EHI), Escalon
IP Holdings, Inc., Escalon Vascular IP Holdings, Inc., Sonomed IP Holdings, Inc., Drew Scientific
Holdings, Inc., and Drew Scientific Group, Plc (Drew) and its subsidiaries. All intercompany
accounts and transactions have been eliminated.
The Company operates in the healthcare market specializing in the development, manufacture,
marketing and distribution of medical devices and pharmaceuticals in the areas of ophthalmology,
diabetes, hematology and vascular access. The Company and its products are subject to regulation
and inspection by the United States Food and Drug Administration (the FDA). The FDA 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. The Companys Internet address
is www.escalonmed.com.
42
3. Significant Accounting Policies
Principles of Consolidation
The 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
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America 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
For 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 90 days or less to be cash and cash equivalents.
Fair Value of Financial Instruments
The On July 1, 2008, the Company adopted Financial Accounting Standards Board (FASB) issued
authoritative guidance related to fair value measurement for financial assets and liabilities. The
carrying amounts for cash and cash equivalents, accounts receivable, line of credit, accounts
payable and accrued liabilities approximate their fair value because of their short-term maturity.
The carrying amounts of long-term debt approximate fair value since the Companys interest rates
approximate current interest rates. While we believe the carrying value of the assets and
liabilities is 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
The Company recognizes revenue from the sale of its products at the time of shipment, when
title and risk of loss transfer. The Company provides products to its distributors at agreed
wholesale prices and to the balance of its customers at set retail prices. Distributors can
receive discounts for accepting high volume shipments. The discounts are reflected immediately in
the net invoice price, which is the basis for revenue recognition. No further material discounts
or sales incentives are given.
The Companys considerations for recognizing revenue upon shipment of product to a distributor
are based on the following:
| Persuasive evidence that an arrangement (purchase order and sales invoice) exists between a willing buyer (distributor) and the Company that outlines the terms of the sale (company information, quantity of goods, purchase price and payment terms). The buyer (distributor) does not have a right of return. |
| Shipping terms are ex-factory shipping point. At this point the buyer (distributor) takes title to the goods and is responsible for all risks and rewards of ownership, including insuring the goods as necessary. | ||
| The Companys price to the buyer (distributor) is fixed and determinable as specifically outlined on the sales invoice. The sales arrangement does not have customer cancellation or termination clauses. | ||
| The buyer (distributor) places a purchase order with the Company; the terms of the sale are cash, COD or credit. Customer credit is determined based on the Companys policy and procedures related to the buyers (distributors) creditworthiness. Based on this determination, the Company believes that collectibility is reasonably assured. |
43
With respect to additional consideration related to the sale of Silicone Oil by Bausch & Lomb
revenue is recognized upon notification from the other parties of amount earned or upon receipt of
royalty payments.
Biocode has fulfilled all of its obligations related to the TECOM agreement and has recognized
the entire amount related to the contract of approximately $888,000 as other income for the year
ended June 30, 2010 (see note 12).
Provision has been made for estimated sales returns based on historical experience.
Shipping and Handling Revenues and Costs
Shipping and handling revenues are included in product revenue and the related costs are
included in cost of goods sold.
Inventories
Raw materials, work in process and finished goods are recorded at lower of cost (first-in,
first-out) or market. The composition of inventories is as follows:
June 30, | ||||||||
2010 | 2009 | |||||||
Raw materials |
$ | 6,914,502 | $ | 7,222,070 | ||||
Work in process |
446,966 | 822,446 | ||||||
Finished goods |
1,044,242 | 2,512,202 | ||||||
8,405,710 | 10,556,718 | |||||||
Valuation allowance |
(1,426,996 | ) | (725,796 | ) | ||||
Total inventory |
$ | 6,978,714 | $ | 9,830,922 | ||||
Valuation allowance activity for the years ended June 30, 2010 and 2009 was as follows:
June 30, | ||||||||
2010 | 2009 | |||||||
Balance, July 1 |
$ | 725,796 | $ | 467,824 | ||||
Provision for valuation allowance |
919,250 | 267,832 | ||||||
Write-offs |
(218,050 | ) | (9,860 | ) | ||||
Balance, June 30 |
$ | 1,426,996 | $ | 725,796 | ||||
44
Accounts Receivable
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 Companys historical trends, specific customer issues and
current economic trends. Accounts are written off when they are determined to be uncollectible
based on managements assessment of individual accounts. Allowance for doubtful accounts activity
for the years ended June 30, 2010 and 2009 was as follows:
June 30, | ||||||||
2010 | 2009 | |||||||
Balance, July 1 |
$ | 641,309 | $ | 473,187 | ||||
Provision for bad debts |
551,295 | 178,255 | ||||||
Write-offs |
(222,489 | ) | (10,133 | ) | ||||
Balance, June 30 |
$ | 970,115 | $ | 641,309 | ||||
Property and Equipment
Property and equipment is 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 3 to 5
years for computer equipment and software, 5 to 7 years for furniture and fixtures and 5 to 10
years for production and test equipment. Depreciation and amortization expense for the years ended
June 30, 2010, 2009 and 2008 was $405,876, $784,347 and $582,511, respectively.
Property and equipment consist of the following at:
June 30, | ||||||||
2010 | 2009 | |||||||
Equipment |
$ | 2,391,504 | $ | 2,946,677 | ||||
Furniture and Fixtures |
91,963 | 62,846 | ||||||
Leasehold Improvements |
76,645 | 33,922 | ||||||
2,560,112 | 3,043,445 | |||||||
Less: Accumulated depreciation and amortization |
(1,887,622 | ) | (2,150,479 | ) | ||||
$ | 672,490 | $ | 892,966 | |||||
Long-lived Assets
Long-lived assets and certain identifiable intangibles to be held and used are reviewed for
impairment whenever events or changes in circumstances indicate that the carrying value may not be
recoverable. An assets value is impaired if managements estimate of the aggregate future cash
flows, undiscounted and without interest charges, to be generated by the asset are less than the
carrying value of the asset. Such cash flows consider factors such as expected future operating
income and historical trends, as well as the effects of demand and competition. To the extent
impairment has occurred, the loss will be measured as the excess of the carrying amount of the
asset over the fair value of the asset. Such estimates require the use of judgment and numerous
subjective assumptions, which if actual experience varies, could result in material differences in
the requirements for impairment charges.
45
Intangible Assets
The Company follows FASB issued authoritative guidance for recording Goodwill and Other
Intangible Assets, which discontinues the amortization of goodwill and identifiable intangible
assets that have indefinite lives. In accordance with FASB issued authoritative guidance, these
assets are tested for impairment on an annual basis. There was no impairment of goodwill for the
year ended June 30, 2010. See footnote 4 for details on goodwill impairment charge related to Drew
and Sonomed in prior periods.
During the fiscal year ended June 30, 2010, the Company reduced its estimate of the useful life of its customer list in the JAS business unit to better reflect the remaining useful life of the list. This change had the effect of increasing
the net loss from continuing operations for the year ended June 30, 2010 by approximately $200,000, or $.03 per share.
Accrued Warranties
The Company provides a limited one year warranty against manufacturers defects on its
products sold to customers. The Companys standard warranties require the Company to repair or
replace, at the Companys 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.
Business Combinations
The Company allocates the purchase price of acquired companies to the tangible and intangible
assets acquired and liabilities assumed based on their estimated fair values. When acquisitions
are deemed material by management, the Company engages independent third-party appraisal firms to
assist in determining the fair values of assets acquired and liabilities assumed. Such a valuation
requires management to make significant estimates and assumption, especially with respect to
intangible assets.
Stock-Based Compensation
Stock-based compensation expense for all share-based payment awards granted after July 1, 2006
is based on the grant date fair value estimate in accordance with the provisions of FASB issued
authoritative guidance. As of June 30, 2010, 2009 and 2008 there was $238,084, $363,244 and
$266,348, respectively, of total unrecognized compensation cost related to non-vested share-based
compensation arrangements under the plans. The remaining cost is expected to be recognized over a
weighted average period of 2.65 years. For the years ended June 30, 2010, 2009 and 2008, $125,160,
$263,729, and $246,757, was recorded as compensation expense, respectively.
Valuations are based upon highly subjective assumptions about the future, including stock
price volatility and exercise patterns. The fair value of share-based payment awards was estimated
using the Black-Scholes option pricing model. Expected volatilities are based on the historical
volatility of the Companys stock. The Company uses historical data to estimate option exercise and
employee terminations. The expected term of options granted represents the period of time that
options granted are expected to be outstanding. The risk-free rate for periods within the expected
life of the option is based on the U.S. Treasury yield curve in effect at the time of the grant.
The Company has historically granted options under the Companys option plans with
an option exercise price equal to the closing market value of the stock on the date of the grant
and with vesting,
primarily for Company employees, either in equal annual amounts over a two to five year period or
immediately, and, primarily for non-employee directors, immediately.
The Company did not receive any cash from share option exercises under stock-based payment
plans for the years ended June 30, 2010, 2009 and 2008. The Company did not realize any tax effect,
which would be a reduction in its tax rate, on options due to the full valuation allowances
established on its deferred tax assets.
The Company measures compensation expense for non-employee stock-based awards based
on the fair value of the options issued as this is used to measure the transaction, as this is more
reliable than the fair value of the services received. Fair value is measured as the value of the
Companys common stock on the date that the commitment for performance by the counterparty has been
reached or the counterpartys
46
performance is complete. The fair value of the equity instrument is
charged directly to compensation expense and additional paid-in capital. For the years ended June
30, 2010, 2009 and 2008, $0, $110,690 and $152,074, was recorded as compensation expense,
respectively.
Research and Development
All research and development costs are charged to operations as incurred.
Advertising Costs
Advertising costs are charged to operations as incurred. Advertising expense for the years
ended June 30, 2010, 2009 and 2008 was $67,959, $121,087, and $173,054, respectively.
Net Income (loss) Per Share
Earnings (loss) 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 and
warrants are considered potential common stock. The dilutive effect, if any, of stock options and
warrants is calculated using the treasury stock method.
A reconciliation of the denominator of the basic and diluted earnings per share for the three
years ended June 30, 2010, 2009 and 2008 is as follows:
2010 | 2009 | 2008 | ||||||||||
Basic Weighted average shares outstanding |
7,526,430 | 7,137,541 | 6,389,008 | |||||||||
Effect of dilutive securities Stock
options and warrants |
0 | 0 | 0 | |||||||||
Diluted weighted average shares outstanding |
7,526,430 | 7,137,541 | 6,389,008 | |||||||||
For the years ended June 30, 2010, 2009 and 2008 the impact of all dilutive securities were
omitted from the diluted earnings per share calculation as they reduce the loss per share
(anti-dilutive). No warrants or options were issued in fiscal year 2010. As of June 30, 2010, 2009
and 2008, respectively, there were 150,000, 270,000 and 120,000 warrants,
respectively, issued to purchase shares
of Escalon common stock were outstanding, respectively (see note 7). These warrants were excluded
from the calculation of diluted
earnings per share as the exercise price of the warrants exceeded the average share price of the
Companys common stock making the warrants anti-dilutive.
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and
liabilities are recognized for the future tax consequences attributable to differences between the financial
statement carrying amounts of existing assets and liabilities and their respective tax bases and operating
loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates
expected to apply to taxable income in the years in which those temporary differences are expected to be
recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in
income in the period that includes the enactment date. Valuation allowances are recorded to reduce
deferred tax assets when it is more likely than not that a tax benefit will not be realized.
The Company follows the
FASB issued authoritative guidance for accounting for income taxes which
provides a comprehensive model for the recognition, measurement, and disclosure in financial statements
47
of uncertain income tax positions that a company has taken or expects to take on a tax return.
Under FIN 48, a company can recognize the benefit of an income tax position only if it is more
likely than not (greater than 50%) that the tax position will be sustained upon tax examination,
based solely on the technical merits of the tax position. Otherwise, no benefit can be recognized.
The tax benefits recognized are measured based on the largest benefit that has a greater than fifty
percent likelihood of being realized upon ultimate settlement. Additionally, companies are required
to accrue interest and related penalties, if applicable, on all tax exposures for which reserves
have been established consistent with jurisdictional tax laws. The Company has elected to recognize
interest expense and penalties related to uncertain tax positions as a component of its provision
for income taxes.
Comprehensive Income (Loss)
The Company reports comprehensive income in accordance with the FASB issued authoritative
guidance which establishes standards for reporting comprehensive income and its component in
financial statements. Comprehensive income, as defined, includes all changes in equity during a
period from non-owner sources.
Foreign Currency Translation
The Company translates the assets and liabilities of international subsidiaries into U.S.
dollars at the current rates of exchange in effect as of each balance sheet date. Revenues and
expenses are translated using average rates in effect during the period. Gains and losses from
translation adjustments are included in accumulated other comprehensive income on the consolidated
balance sheet. Foreign currency transaction gains or losses are recognized in current operations
and have not been significant to the Companys operating results in any period. In addition, the
effect of foreign currency rate changes on cash and cash equivalents has not been significant in
any period.
Subsequent Events
The
Company has evaluated subsequent events through October 12, 2010, which is the date the
financial statements were available to be issued.
Reclassification
Certain amounts were reclassed from the June 30, 2009 and 2008 presentations to conform with
the current year presentation.
New Accounting Pronouncements
Recently Issued Accounting Standards
In October 2009, FASB issued amended revenue recognition authoritative guidance
for arrangements with multiple deliverables. The new authoritative guidance eliminates the residual
method of revenue recognition and allows the use of managements best estimate of selling price for
individual elements of an arrangement when vendor specific objective evidence (VSOE), vendor
objective evidence (VOE) or third-party evidence (TPE) is unavailable. This guidance is
effective for all new or materially modified arrangements entered into on or after January 1, 2011,
with earlier application permitted as of the beginning of any prior fiscal year. Full retrospective
application of the new guidance is optional. The Company is currently assessing the impact that the
implementation of this new guidance will have on the Companys financial position and operations.
In October 2009, the FASB issued authoritative guidance that amends the scope of existing
software revenue recognition accounting. Tangible products containing software components and
non-software components that function together to deliver the products essential functionality
would be scoped out of the accounting guidance on software and accounted for based on other
appropriate revenue recognition guidance. This guidance is effective for all new or materially
modified arrangements entered into on or
48
after January 1, 2011, with earlier application permitted as of the beginning of any prior fiscal
year. Full retrospective application of the new guidance is optional. This guidance must be adopted
in the same period that the Company adopts the amended accounting for arrangements with multiple
deliverables described in the preceding paragraph. The Company is currently assessing the impact
that the implementation of this new guidance will have on the Companys financial position and
operations.
On July 1, 2009, the FASB issued the FASB Accounting Standards Codification (the
Codification). The Codification became the single authoritative source of GAAP recognized by the
FASB. The Codification superseded all previously-existing non-Securities and Exchange Commission
accounting and reporting standards, and all other non-grandfathered non-Securities and Exchange
Commission accounting literature not included in the Codification became nonauthoritative. The
Codification was effective for interim and annual reporting periods ending after September 15,
2009. The Company adopted the Codification for the quarter ended September 30, 2009. The Companys
adoption of the Codification did not have any impact on the Companys financial position and
operations as this change is disclosure-only in nature.
In June 2009, the FASB issued authoritative guidance that amends the consolidation guidance
applicable to variable interest entities and requires enhanced disclosures intended to provide
users of financial statements with more transparent information about an enterprises involvement
in a variable interest entity. This guidance will be effective beginning with the Companys
consolidated financial statements for the year ending June 30, 2011 and the quarterly periods
thereof. The Company does not expect the impact of adoption to be material on its financial
position and operations.
In June 2009, the FASB issued authoritative guidance that eliminates the concept of a
qualifying special-purpose entity, changes the requirements for derecognizing financial assets and
requires enhanced disclosure to provide financial statement users with greater transparency about
transfers of financial assets, including securitization transactions and an entitys continuing
involvement in and exposure to the risks
related to the transfer of financial assets. This guidance will be effective beginning with the
Companys consolidated financial statements for the year ending June 30, 2011 and the quarterly
periods thereof. The Company does not expect the impact of adoption to be material on its financial
position and operations.
In May 2009, the FASB issued amended authoritative guidance on subsequent event accounting
which sets forth: (i) the period after the balance sheet date during which management of a
reporting entity should evaluate events or transactions that may occur for potential recognition or
disclosure in the financial statements; (ii) the circumstances under which an entity should
recognize events or transactions occurring after the balance sheet date in its financial
statements; and (iii) the disclosures that an entity should make about events or transactions that
occurred after the balance sheet date. These guidelines were effective for interim and annual
periods ending after June 15, 2009, and the Company adopted them in the quarter ended June 30,
2009.
4. Intangible Assets
Goodwill, Trademarks and Trade Names
Goodwill, trademarks and trade names represent intangible assets obtained from EOI, Endologix,
Sonomed and Drew acquisitions. Goodwill represents the excess of purchase price over the fair
value of net assets acquired.
The Company adopted FASB authoritative guidance effective July 1, 2001 for goodwill and
identified intangible assets that have indefinite lives. These assets are no longer amortized but
reviewed for impairment annually or more frequently if certain indicators arise.
In accordance with authoritative guidance effective July 1, 2001, the Company discontinued the
amortization of goodwill and identifiable intangible assets that have indefinite lives. Intangible
assets that have finite lives continue to be amortized over their estimated useful lives.
Management has evaluated the carrying value of goodwill and its identifiable intangible assets that
have indefinite lives during each of the
49
fiscal years subsequent to July 1, 2001, utilizing discounted cash flows of the respective business
units. After evaluating the discounted cash flow of each of its respective business units,
management concluded that the carrying value of goodwill and identifiable intangible assets at
Sonomed and Drew exceeded their fair values at June 30, 2009 and 2008, respectively, and therefore
were impaired. In accordance with SFAS 142, these intangible assets will continue to be assessed
on an annual basis, and impairment, if any, would be recorded as a charge against income from
operations.
The authoritative guidance makes use of the concept of reporting units. All acquisitions must
be assigned to a reporting segment or unit. Reporting units have been defined under the standards
to be the same as or one level below an operating segment, as defined by FASB issued authoritative
guidance related to disclosures about segments of an enterprise and related information.
The Company tests goodwill for possible impairment on an annual basis and at any other
time events occur or circumstances indicate that the carrying amount of goodwill may be impaired.
There was no impairment of goodwill for the year ended June 30, 2010.
Goodwill Impairment-Sonomed
During the last six months of fiscal year ended June 30, 2009, Sonomed experienced a
significant decrease in demand for its product offering. The Company believes that this decrease
in volume was related to the global economic downturn and the effect it has had on the ability of
Sonomeds traditional customer base to add additional or upgraded capital equipment at this time.
These troubling economic conditions have also lead to increased sales discounts to Sonomeds
distributors in order to entice end users to purchase or to compete with toughening competition.
These uncertainties in the market along with increased competition from existing competitors and
emerging technologies have made it difficult for Sonomed to project future revenue and cash flow.
The effect these conditions had on fiscal 2009s actual performance as compared to budgeted
performance was significant with actual profitability approximately 65% lower than anticipated. The
Company believed that these negative sales and profitability trends will continue for the
foreseeable future and thus will have a significant negative affect on Sonomeds estimated future
operating results and cash flow. Sonomed reduced its work force by 13% during the fourth quarter
of the year ended June 30, 2009 in response to these uncertainties. Sonomed projected that these
events will negatively affect the evaluation of the future operating results and cash flows of
Sonomed.
The Company tests goodwill for possible impairment on an annual basis and at any other time
events occur or circumstances indicate that the carrying amount of goodwill may be impaired.
The first step of the SFAS No. 142 impairment analysis consists of a comparison of the fair
value of the reporting segment with its carrying amount, including the goodwill. The fair value was
determined based on the income approach, which estimates the fair value based on the future
discounted cash flows. Under the income approach, the Company assumed, with respect to Sonomed, a
forecasted cash flow period of five years, long-term annual growth rates of 3% and a discount rate
of 19%.
Based on the annual income approach analysis that was separately performed for each operating
segment, it was determined that in the Sonomed segment the carrying amount of the goodwill was in
excess of its respective fair value. As such, the Company was required to perform the second step
analysis for Sonomed in order to determine the amount of the goodwill impairment. The second step
analysis consisted of comparing the implied fair value of the goodwill with the carrying amount of
the goodwill, with an impairment charge resulting from any excess of the carrying value of the
goodwill over the implied fair value of the goodwill. Based on the second step analysis, the
Company concluded that all $9,526,000 of the goodwill recorded at Sonomed was impaired. As a
result, the Company recorded a non-cash goodwill impairment charge to continuing operations
totaling $9,526,000 for the year ended June 30, 2009.
The determination as to whether a write-down of goodwill is necessary involves significant
judgment based on short-term and long-term projections of the Company. The assumptions supporting
the estimated future cash flows of the reporting segment, including profit margins, long-term
forecasts, discount rates and terminal growth rates, reflect the Companys best estimates.
50
Goodwill Impairment-Drew
Drew encountered a series of events during the third and fourth quarters of the fiscal year
ended June 30, 2008 that had a material effect on the valuation of our goodwill related to the
purchase of Drew. These events include a development delay of Drews DS-360 instrument that Drew
had previously anticipated would be completed by the fourth quarter of the fiscal year ending June
30, 2008, and a contract dispute with Point Care Technologies (PCT) that has delayed the
development of Drews 2280 HT HIV instrument (see footnote 9 Commitments and Contingencies in the
notes to the financial statements in the Companys Form 10-K annual report for the fiscal year
ended June 30, 2008).
The development of Drews proposed new diabetes instrument, the DS-360, has been indefinitely
delayed because of difficulties related to the final phase of its development. The DS-360 was to be
Drews next generation diabetes instrument, which is a key line of business for Drew. The
uncertainty of the DS-360s completion combined with the continued aging of Drews existing
diabetes instrument offerings had a negative impact on Drews estimated future operating results
and cash flow. Drew, in consultation with independent consultants, continues to evaluate the
development status of the DS-360 project. Until the evaluation is completed, Drew cannot estimate
the timing of the 510(k) application submission for the instrument to the FDA or whether the
submission will be made.
Also, Drew had anticipated that the joint development project it had undertaken with PCT of
Drews 2280 HT HIV instrument would be completed during the fiscal year ended June 30, 2008. In
December 2008 Drew settled a contract dispute with PCT relating to this project. As part of the
settlement, dated November 3, 2008 Drew and PCT are no longer jointly developing the 2280 HT HIV
instrument and Drew is unable to estimate when or if the 2280 HT HIV instrument will be completed.
Drew undertook the development effort at considerable cost because it believed that the 2280 HT HIV
instrument had significant potential in monitoring the status of HIV patients. The uncertainty
whether the 2280 HT HIV will be completed has had a negative impact on Drews estimated future
operating results and cash flow.
Because of these developments and the continued diminished operating results of Drews aging
legacy projects, the Company reduced its work force during the fourth quarter of the year ended
June 30, 2008 by 23 positions and restructured certain management responsibilities. These events
negatively affected the evaluation by the Company of the future operating results and cash flows of
Drew.
The Company tests goodwill for possible impairment on an annual basis and at any other time
events occur or circumstances indicate that the carrying amount of goodwill may be impaired.
The first step of the FASB authoritative guidance impairment analysis consists of a
comparison of the fair value of the reporting segment with its carrying amount, including the
goodwill. The fair value was determined based on the income approach, which estimates the fair
value based on the future discounted cash flows. Under the income approach, the Company assumed,
with respect to Drew, a forecasted cash flow period of five years, long-term annual growth rates of
5% and a discount rate of 14%.
Based on the annual income approach analysis that was separately performed for each operating
segment, it was determined that in the Drew segment the carrying amount of the goodwill was in
excess of its respective fair value. As such, the Company was required to perform the second step
analysis for Drew in order to determine the amount of the goodwill impairment. The second step
analysis consisted of comparing the implied fair value of the goodwill with the carrying amount of
the goodwill, with an impairment charge resulting from any excess of the carrying value of the
goodwill over the implied fair value of the goodwill. Based on the second step analysis, the
Company concluded that all $9,574,655 of the goodwill recorded at Drew was impaired. As a result,
the Company recorded a non-cash goodwill impairment charge to continuing operations totaling
$9,574,655 for the year ended June 30, 2008.
The determination as to whether a write-down of goodwill is necessary involves significant
judgment based on short-term and long-term projections of the Company. The assumptions supporting
the estimated future cash flows of the reporting segment, including profit margins, long-term
forecasts, discount rates and terminal growth rates, reflect the Companys best estimates.
51
The following table presents unamortized intangible assets by business segment as of June 30,
2010 and 2009:
2010 | 2009 | |||||||
Net | Net | |||||||
Carrying | Carrying | |||||||
Amount | Amount | |||||||
Goodwill |
||||||||
JAS |
$ | 93,181 | $ | 93,181 | ||||
Vascular |
0 | 941,218 | ||||||
Medical/Trek/EMI |
1,030,837 | 1,030,837 | ||||||
Total |
$ | 1,124,018 | $ | 2,065,236 | ||||
2010 | 2009 | |||||||
Net | Net | |||||||
Carrying | Carrying | |||||||
Amount | Amount | |||||||
Trademarks and tradenames |
||||||||
Sonomed |
$ | 601,806 | $ | 601,806 | ||||
JAS |
89,000 | 89,000 | ||||||
Medical/Trek/EMI |
3,200 | 3,200 | ||||||
Total |
$ | 694,006 | $ | 694,006 | ||||
Patents
It is the Companys practice to seek patent protection on processes and products in various
countries. Patent application costs are capitalized and amortized over their estimated useful
lives, not exceeding 17 years, on a straight-line basis from the date the related patents are
issued. Costs associated with patents no longer being pursued are expensed. Accumulated patent
amortization was $549,477 and $203,607 at June 30, 2010 and 2009, respectively. Amortization
expense for the years ended June 30, 2010, 2009 and 2008 was $310,120, $149,205 and $89,123,
respectively.
Amortization expense, relating entirely to patents, is estimated to be approximately $261,000
in each year 2011 and 2012, $234,000 in 2013 and $226,000 in each year 2014 and 2015.
Covenant Not to Compete and Customer Lists
The Company recorded the value of covenants not to compete and customer lists as intangible
assets as part of the acquisitions of MRP, JAS and Biocode (see note 14). The valuation was based
on the fair market value of these assets at the time of acquisition. These assets are amortized
over their estimated useful lives, between 5 and 10 years, on a straight-line basis from the date
of acquisition. Accumulated amortization was $888,778 and $449,395 at June 30, 2010 and 2009,
respectively. Amortization expense for the years ended June 30, 2010, 2009 and 2008 was $439,383,
$190,073 and $96,647, respectively.
Amortization expense, relating entirely to covenant not to compete and the customer list is
estimated to be approximately $422,000 in 2011, $385,000 in each year 2012 and 2013 and $288,000 in
2014.
52
The following table presents amortized intangible assets as of June 30, 2010:
Adjusted | ||||||||||||||||||||
Gross | Gross | |||||||||||||||||||
Carrying | Carrying | Accumulated | Net Carrying | |||||||||||||||||
Amount | Impairment | Amount | Amortization | Value | ||||||||||||||||
Amortized Intangible Assets
Patents |
||||||||||||||||||||
Medical/Trek/EMI/Drew |
$ | 251,361 | $ | | $ | 251,361 | $ | (165,186 | ) | $ | 86,175 | |||||||||
Biocode |
1,582,225 | 1,582,225 | (384,291 | ) | 1,197,934 | |||||||||||||||
Total |
$ | 1,833,586 | $ | 0 | $ | 1,833,586 | $ | (549,477 | ) | $ | 1,284,109 | |||||||||
Covenant Not To Compete/
Customer List |
||||||||||||||||||||
JAS |
$ | 1,461,397 | $ | | $ | 1,461,397 | $ | (375,092 | ) | $ | 1,086,305 | |||||||||
Biocode |
464,676 | | 464,676 | (107,635 | ) | 357,041 | ||||||||||||||
EMI |
442,969 | | 442,969 | (406,051 | ) | 36,918 | ||||||||||||||
Total |
$ | 2,369,042 | $ | 0 | $ | 2,369,042 | $ | (888,778 | ) | $ | 1,480,264 | |||||||||
The following table presents amortized intangible assets as of June 30,
2009:
Adjusted | ||||||||||||||||||||
Gross | Gross | |||||||||||||||||||
Carrying | Carrying | Accumulated | Net Carrying | |||||||||||||||||
Amount | Impairment | Amount | Amortization | Value | ||||||||||||||||
Amortized Intangible
Assets Patents |
||||||||||||||||||||
Medical/Trek/EMI/Drew |
$ | 254,851 | $ | | $ | 254,851 | $ | (133,333 | ) | $ | 121,518 | |||||||||
Biocode |
1,772,928 | | 1,772,928 | (70,274 | ) | 1,702,654 | ||||||||||||||
Total |
$ | 2,027,779 | $ | | $ | 2,027,779 | $ | (203,607 | ) | $ | 1,824,172 | |||||||||
Covenant Not To Compete/
Customer List |
||||||||||||||||||||
JAS |
$ | 1,461,397 | $ | | $ | 1,461,397 | $ | (97,426 | ) | $ | 1,363,971 | |||||||||
Biocode |
425,668 | | 425,668 | (42,566 | ) | 383,102 | ||||||||||||||
EMI |
442,969 | | 442,969 | (309,403 | ) | 133,566 | ||||||||||||||
Total |
$ | 2,330,034 | $ | | $ | 2,330,034 | $ | (449,395 | ) | $ | 1,880,639 | |||||||||
53
5. Accrued Expenses
The following table presents accrued expenses:
June 30, 2010 | June 30, 2009 | |||||||
Accrued compensation |
$ | 1,167,113 | $ | 953,390 | ||||
Warranty accruals |
168,714 | 164,820 | ||||||
Other accruals |
1,164,052 | 1,801,330 | ||||||
Total accrued expenses |
$ | 2,499,879 | $ | 2,919,540 | ||||
Accrued compensation as of June 30, 2010 and 2009 primarily relates to payroll, bonus and
vacation accruals, and payroll tax liabilities.
6. Long-Term Debt
On December 31, 2008 Drew acquired certain assets of Biocode for $5,922,000 (4,200,000 Euros)
plus acquisition costs of approximately $129,000. The sales price was payable in cash of
approximately $324,000 (approximately 231,000 Euros) and $5,865,000 in debt from Drew. The seller
provided financing is collateralized by certain assets of Biocode. Biocode assets were vertically
integrated into the Companys clinical diagnostics business that includes Drew and JAS. The
seller-provided financing, which is guaranteed by the Company, requires payment over four years as
follows:
| the first interest-only payment was due in December of 2009 at an annual interest rate of 7%; this payment was paid on June 30, 2010 pursuant to an agreement reached with the seller; | ||
| thereafter, every nine months after June 30, 2010, an interest payment is due at an annual interest rate of 7%; | ||
| June 30, 2010 the principal payment of Euro 800,000 was made; | ||
| June 30, 2011 a principal payment of Euro 1,000,000 is due; | ||
| December 31, 2011 a principal payment of Euro 1,000,000 is due; and | ||
| December 31, 2012 a principal payment of Euro 1,375,000 is due. |
On May 29, 2008 Drew issued a note payable in the amount of $752,623 related to the purchase
of JAS Diagnostics, Inc. The note is collateralized by JAS common stock. Principal was payable in
six quarterly installments of $124,437 plus interest at the prime rate as published by the Bank of
America. On August 30, 2009 one of the notes related to the JAS acquisition was renegotiated. The
amount outstanding on August 30, 2009 was $178,370; this amount is being repaid in 12 equal
installments of $14,864 plus interest at 7%. The remaining balance of this debt as of June 30,
2010 is $33,692.
54
Annual maturities of long-term debt are as follows:
Year | ||||
Ending | ||||
June 30, | Total | |||
2011 |
$ | 1,254,492 | ||
2012 |
1,220,800 | |||
2013 |
1,695,446 | |||
Total |
4,170,738 | |||
Current portion of long-term debt |
1,254,492 | |||
Long-term portion |
$ | 2,916,246 | ||
7. Capital Stock Transactions
Stock Option Plans
As of June 30, 2010, Escalon had in effect five employee stock option plans that provide for
incentive and non-qualified stock options. After accounting for shares issued upon exercise of
options, a total of 1,281,152 shares of the Companys common stock remain available for issuance as
of June 30, 2010. 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 over five
years and the options are exercisable over a period no longer than 10 years after the grant date.
As of June 30, 2010, options to purchase 965,688 shares of the Companys common stock were
outstanding, of which 849,438 were exercisable, and 129,575 shares were reserved for future grants.
The following is a summary of Escalons stock option activity and related information for the
fiscal years ended June 30, 2010, 2009 and 2008:
55
2010 | 2009 | 2008 | |||||||||||||||||||||||||
Common | Weighted | Common | Weighted | Common | Weighted | ||||||||||||||||||||||
Stock | Average | Stock | Average | Stock | Average | ||||||||||||||||||||||
Options | Exercise Price | Options | Exercise Price | Options | Exercise Price | ||||||||||||||||||||||
Outstanding at the beginning of the year |
1,039,077 | $ | 4.70 | 884,577 | $ | 5.27 | 752,535 | $ | 5.53 | ||||||||||||||||||
Granted |
| $ | | 154,500 | $ | 2.21 | 135,500 | $ | 3.05 | ||||||||||||||||||
Exercised |
| $ | | | $ | | (2,458 | ) | $ | 3.02 | |||||||||||||||||
Forfeited |
(73,389 | ) | $ | 2.10 | | $ | | (1,000 | ) | $ | 3.05 | ||||||||||||||||
Outstanding at the end of the year |
965,688 | $ | 4.65 | 1,039,077 | $ | 4.70 | 884,577 | $ | 5.27 | ||||||||||||||||||
Exercisable at the end of the year |
849,438 | 886,944 | 779,519 | ||||||||||||||||||||||||
Weighted average fair value of options
granted during the year |
$ | | $ | 2.21 | $ | 3.05 | |||||||||||||||||||||
The following table summarizes information about stock options outstanding as of June 30,
2010: |
Weighted | |||||||||||||||||||||||
Number | Average | Number | |||||||||||||||||||||
Outstanding | Remaining | Weighted | Exercisable | Weighted | |||||||||||||||||||
at | Contractual | Average | at | Average | |||||||||||||||||||
June, 30 | Life | Exercise | June, 30 | Exercise | |||||||||||||||||||
2010 | (Years) | Price | 2010 | Price | |||||||||||||||||||
Range of Exercise Prices | |||||||||||||||||||||||
$1.45 to $2.12 |
46,817 | 1.55 | $ | 1.55 | 46,817 | $ | 1.55 | ||||||||||||||||
$2.37 to $2.77 |
419,492 | 7.33 | $ | 2.65 | 303,242 | $ | 2.65 | ||||||||||||||||
$4.97 to $5.59 |
73,000 | 5.28 | $ | 5.05 | 73,000 | $ | 5.05 | ||||||||||||||||
$6.19 to $6.19 |
168,250 | 4.08 | $ | 6.19 | 168,250 | $ | 6.19 | ||||||||||||||||
$6.94 to $8.06 |
258,129 | 4.47 | $ | 7.41 | 258,129 | $ | 7.41 | ||||||||||||||||
Total |
965,688 | 849,438 | |||||||||||||||||||||
Compensation expense related to stock options for the years ended June 30, 2010, 2009 and
2008 was $125,160, $263,729 and $246,757, respectively.
56
Sale of Common Stock and Warrants
On November 20, 2008, the Company completed a $1,100,000 private placement of common stock and
common stock purchase warrants to accredited investors. The Company sold 1,000,000 shares of common
stock at $1.10 per share. The investors also received warrants to purchase an additional 150,000
shares of common stock at an exercise price of $1.21 per share, which expire in 5 years. The
warrants have a fair value of $132,114. The fair value of the warrants was estimated at the date of
agreement using the Black-Scholes pricing method. The net proceeds to the Company from the
offering, after fees and expenses of $1,029,000 have been allocated among common stock and warrants
based on their relative fair values. As the result of the private placement, the Company had
7,526,430 shares of common stock outstanding, not including the shares issuable upon the exercise
of the warrants.
The shares were offered in reliance on an exemption from the registration requirements of the
Securities Act of 1933 (the Securities Act). The shares may not be offered or sold in the United
States absent an effective registration statement or an applicable exemption from the registration
requirements of the Securities Act and applicable state securities laws.
On March 17, 2004, the Company completed a $10,400,000 private placement of common stock and
common stock purchase warrants to accredited and institutional investors. The Company sold 800,000
shares of its common stock at $13.00 per share. The investors also received warrants to purchase
an additional 120,000 shares of common stock at an exercise price of $15.60 per share. The warrants
expired on September 13, 2009. The securities were sold pursuant to the exemptions from
registration of Rule 506 of Regulation D and Section 4(2) under the Securities Act of 1933. The
Company has subsequently filed a registration statement with the Securities and Exchange
Commission, declared effective on April 20, 2004, to register for resale by the holders all of the
common stock issued in conjunction with this private placement and common stock purchasable upon
exercise of the warrants.
The net proceeds to the Company from the offering, after costs associated with the offering,
of $9,787,918, have been allocated among common stock and warrants based on their relative fair
values. The Company used the Black-Sholes pricing model to determine the fair value of the
warrants to be $1,601,346.
57
8. Income Taxes
The provision for income taxes for the years ended June 30, 2010, 2009 and 2008 consists of
the following:
2010 | 2009 | 2008 | ||||||||||
Current income tax provision |
||||||||||||
Federal |
$ | | $ | | $ | | ||||||
State |
| | 134,990 | |||||||||
| | 134,990 | ||||||||||
Deferred income tax provision |
||||||||||||
Federal |
324,169 | (2,328,920 | ) | 130,565 | ||||||||
State |
76,040 | (546,290 | ) | 30,626 | ||||||||
Change in valuation allowance |
(400,208 | ) | 2,875,210 | (161,191 | ) | |||||||
| | | ||||||||||
Income tax expense |
$ | | $ | | $ | 134,990 | ||||||
Income taxes as a percentage of income for the years ended June 30, 2010, 2009 and 2008
differ from statutory federal income tax rate due to the following:
2010 | 2009 | 2008 | ||||||||||
Statutory federal income tax rate |
-34.0 | % | -34.0 | % | -34.0 | % | ||||||
Change in valuation allowance |
34.0 | % | 34.0 | % | 34.0 | % | ||||||
State income taxes, net of federal tax impact |
| | | |||||||||
Other |
| | | |||||||||
Effective income tax rate |
0.0 | % | 0.0 | % | 0.0 | % | ||||||
As of June 30, 2010, the Company had deferred income tax assets of $12,935,577. The
deferred income tax assets has a valuation allowance of $12,921,341. The valuation allowance is
based on uncertainty with respect to the ultimate realization of net operating loss carryforwards.
The components of the net deferred tax income tax assets and liabilities as of June 30, 2010
and 2009 are as follows:
58
2010 | 2009 | |||||||
Deferred income tax assets: |
||||||||
Net operating loss carryforward |
$ | 10,447,391 | $ | 10,872,291 | ||||
Executive post retirement costs |
349,459 | 349,459 | ||||||
General business credit |
207,698 | 450,199 | ||||||
Allowance for doubtful accounts |
313,963 | 218,045 | ||||||
Accrued vacation |
159,054 | 167,154 | ||||||
Inventory reserve |
401,457 | 236,219 | ||||||
Accelerated depreciation |
| 808 | ||||||
Accelerated amortization on goodwill
and other intangible assets |
998,707 | 971,335 | ||||||
Warranty reserve |
57,848 | 56,039 | ||||||
Total deferred income tax assets |
12,935,577 | 13,321,549 | ||||||
Valuation allowance |
(12,921,341 | ) | (13,321,549 | ) | ||||
14,236 | | |||||||
Deferred income tax liabilities: |
||||||||
Accelerated depreciation |
(14,236 | ) | | |||||
Total deferred income tax liabilities |
(14,236 | ) | | |||||
$ | 0 | $ | | |||||
As of June 30, 2010, the Company has a valuation allowance of $12,921,341, which
primarily relates to the federal net operating loss carryforwards. 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 Companys earnings history, the number of years the
Companys operating loss and tax credits 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. Any tax benefits
related to stock options that may be recognized in the future through reduction of the associated
valuation allowance will be recorded as additional paid-in capital. The Company has available
federal and state net operating loss carry forwards of approximately $29,900,000 and $2,933,000,
respectively, of which $5,769,000 and $1,983,000, respectively, will expire over the next ten
years, and $24,131,000 and $949,000, respectively, will expire in years eleven through twenty.
Approximately $3,787,000 of federal net operating losses expired June 30, 2010. Not included in the
$29,900,000 federal net operating loss is approximately $8.2 million federal NOL carry forward at
June 30, 2010 which represents amounts that were transferred to the Company as a result of the
acquisition of Drew. Use of this transferred NOL could be limited under Section 382 and can only
be used against future Drew taxable income. Any tax benefit realized from such use would first
reduce acquired goodwill.
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 Companys income tax
provision and managements assessment of the realizability of the Companys 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 Companys results of operations in the period in which the benefit is determined by
the Company.
59
Effective July 1, 2007, the Company adopted the FASB authoritative guidance which prescribes a
model for the recognition and measurement of a tax position taken or expected to be taken in a tax
return, and provides guidance on derecognition, classification, interest, penalties, disclosure and
transition. Implementation of the FASB authoritative guidance did not result in a cumulative
effect adjustment to retained earnings. With few exceptions, the Company is no longer subject to
audits by tax authorities for tax years prior to 2007. 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, 2010, the Company did not have any significant unrecognized tax benefits.
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.
9. Commitments and Contingencies
Commitments
The Company leases its manufacturing, research and corporate office facilities and certain
equipment under non-cancelable operating lease arrangements. The future annual amounts to be paid
under these arrangements as of June 30, 2010 are as follows:
Lease | |||||
Year Ending | Obligations | ||||
2011 |
$ | 862,654 | |||
2012 |
819,940 | ||||
2013 |
837,218 | ||||
2014 |
638,733 | ||||
2015 |
515,211 | ||||
Thereafter |
791,169 | ||||
Total |
$ | 4,464,925 | |||
Rent expense charged to continuing operations during the years ended June 30, 2010, 2009 and
2008 was approximately $854,800, $782,700 and $711,778, respectively.
Contingencies
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
Companys business, financial condition or results of operations.
60
10. Retirement and Post-Retirement Plans
The Company adopted a 401(k) retirement plan effective January 1, 1994. The Companys
employees become eligible for the plan commencing on the date of employment. Company contributions
are discretionary, and no Company contributions have been made since the plans inception.
On January 14, 2000, the Company acquired Sonomed. Sonomed adopted a 401(k) retirement plan
effective on January 1, 1993. This plan has continued subsequent to the acquisition and is
available only to Sonomed employees. The Companys discretionary contribution for the fiscal years
ended June 30, 2010, 2009 and 2008 was $0, $35,788, and $36,699, respectively.
On July 23, 2004, the Company acquired Drew. Drew adopted a 401(k) retirement plan effective
on July 1, 1995. This plan has continued subsequent to the acquisition and is available only to
Drews United States employees. Company contributions are discretionary, and no contributions have
been made since Drew was acquired by the Company. Drew also has two defined contribution
retirement plans which were effective November 24, 2002 and February 1, 1992. These plans have
continued subsequent to the acquisition and are available only to Drews United Kingdom Employees.
Drew contributions for the fiscal years ended June 30, 2010, 2009 and 2008 was $0, $28,766 and
$31,242, respectively.
On June 23, 2005, the Company entered into a Supplemental Executive Retirement Benefit
Agreement with its Chairman and Chief Executive Officer. The agreement provides for the payment of
supplemental retirement benefits to the covered executive in the event of his termination of
services with the Company under the following circumstances.
| If the covered executive retires, the Company would be obligated to pay the executive $8,000 per month for life, with payments commencing the month after retirement. If the covered executive were to die within a period of three years after such retirement, the Company would be obligated to continue making such payments until a minimum of 36 monthly payments have been made to the covered executive and his beneficiaries in the aggregate. | ||
| If the covered executive dies before his retirement while employed by the Company, the Company would be obligated to make 36 monthly payments to his beneficiaries of $8,000 per month commencing in the month after his death. | ||
| If the covered executive were to become disabled while employed by the Company, the Company would be obligated to pay the executive $8,000 per month for life, with payments commencing the month after he suffers such disability. If the covered executive were to die within three years after suffering such disability, the Company would be obligated to continue making such payments until a minimum of 36 monthly payments have been made to the covered executive and his beneficiaries in the aggregate. | ||
| If the covered executives employment with the Company is terminated by the Company, or if the executive terminates his employment with the Company for good reason, as defined in the agreement, the Company would be obligated to pay the executive $8,000 per month for life. If the covered executive were to die within a period of three years after such termination, the Company would be obligated to continue making such payments until a minimum of 36 monthly payments have been made to the covered executive and his beneficiaries in the aggregate. | ||
$1,028,000 was accrued at June 30, 2010 and 2009, which represents the approximate present value of the supplemental retirement benefits awarded. |
61
11. Other Revenue
Bio-Rad Laboratories, Inc. Royalty
The royalty received from Bio-Rad Laboratories, Inc. (Bio-Rad) relates to a certain
non-exclusive Eighth Amendment to an OEM Agreement (OEM Agreement) between the Companys Drew
subsidiary and Bio-Rad, dated July 19, 1994. Bio-Rad pays a royalty based on sales of certain of
Drews products in certain geographic regions.
The material terms of the OEM Agreement, provided:
| Drew receives an agreed royalty per test; | ||
| Royalty payments will be made depending on the volume of tests provided by Bio-Rad. If less than 3,750 tests per month are provided by Bio-Rad, Bio-Rad will calculate the number of tests used on a quarterly basis in arrears and pay Drew within 45 days of the end of the quarter. If more than 3,750 tests per month are provided by Bio-Rad, Bio-Rad will pay an estimated monthly royalty and within 45 days of the end of the quarter will make final settlement upon the actual number of tests. |
While the agreement, as amended by the Eighth Amendment, expired on May 15, 2005, the parties
have continued to operate under the terms of the expired agreement pending negotiation of a
potential extension and/or revision.
12. TECOM Agreement
On June 25, 2009 BioCode entered into a License and Supply Agreement with TECOM Science
Corporation (TECOM) for the sale of certain intellectual property and distribution rights in
China from Biocode for the purpose of manufacturing the Xenia instrument and the purchasing of
reagents for the Xenia for its own use and for sale to its customers in China for 750,000 Euros.
TECOM has the exclusive right to manufacture the Xenia into a form for marketing and sale to end
users under TECOMS trademark and/or trade name within China. TECOM has the exclusive rights to
constitute the Xenia reagents into a form for marketing and sale to end users under TECOMs
trademark and/or trade name within China. TECOM provided Biocode an exclusive right to the use of
any improvements or modifications to the Xenia. The Agreement remains in effect for a period of 20
years and is renewable for an additional 10 years. Biocode has fulfilled all of its
responsibilities under the contract and has recognized the entire contract amount in other revenue
for the year ended June 30, 2010.
The following table presents other revenue received by the Company for the years ended June
30, 2010, 2009 and 2008:
2010 | 2009 | 2008 | ||||||||||
Bio-Rad royalty |
$ | 48,215 | $ | 132,807 | $ | 222,075 | ||||||
Other income-JAS |
49,236 | 0 | 0 | |||||||||
TECOM royalty-BHH |
887,610 | 0 | 0 | |||||||||
Total |
$ | 985,061 | $ | 132,807 | $ | 222,075 | ||||||
62
13. Discontinued Operations
In an effort to enhance stockholder value, improve working capital and enable us to focus on
the Companys core in-vitro diagnostics and ophthalmology manufacturing businesses, on April
30, 2010 the Company divested certain Vascular Access assets held by its Vascular Access
subsidiaries to Vascular Solutions, Inc. The total sales price was $5,750,000, consisting of cash
of $5,000,000 at closing and $750,000 payable in cash upon the successful completion of the
transfer of the manufacturing to Vascular Solutions, Inc. plus a one- time earn-out payment in an
amount equal to 25% of the net sales of the VascuView TAP products sold by Vascular Solutions, Inc.
between July 1, 2010 and June 30, 2011. The manufacturing transfer was completed on August 31,
2010. During this four-month transition, the Company continued to manufacture product in its
Wisconsin facility under a supply agreement concurrently entered into with Vascular Solutions, Inc.
The supply agreement ended on August 30, 2010 and the company
has no significant continuing involvement in the operations of
Vascular. Vascular Access generated approximately $210,000 in
gross profit related to the supply agreement.
The following table summarizes the results of discontinued operations for the three years
ended June 30, 2010 (in thousands):
2010 | 2009 | 2008 | ||||||||||
Revenue, net |
$ | 3,427 | $ | 3,868 | $ | 4,119 | ||||||
Cost of Goods Sold |
1,574 | 1,450 | 1,538 | |||||||||
Market, general and administrative |
1,612 | 1,786 | 1,984 | |||||||||
Research & Development |
260 | 219 | 260 | |||||||||
Total Costs |
3,446 | 3,455 | 3,782 | |||||||||
Net income (loss) from operations |
(19 | ) | 413 | 337 | ||||||||
Gain on sale of assets |
3,493 | | | |||||||||
Net income |
$ | 3,474 | $ | 413 | $ | 337 | ||||||
Assets and liabilities of discontinued operations included in the consolidated balance sheets are
summarized as follows at June 30, 2010 (in thousands):
2010 | ||||
Assets |
||||
Accounts receivable, trade |
$ | 325 | ||
Inventory |
342 | |||
Other assets |
7 | |||
Receivable from sale of vascular assets |
750 | |||
Total Assets |
$ | 1,424 | ||
Liabilities |
||||
Payable related to sale of vascular assets |
500 | |||
Accrued expenses and other liabilities |
$ | 206 | ||
Net assets of discontinued operations |
$ | 718 | ||
63
14. Acquisition of Biocode Hycel and JAS Diagnostics, Inc.
Biocode Hycel Acquisition
On December 31, 2008 Drew acquired certain assets of Biocode for $5,922,000 (4,200,000 Euros)
plus acquisition costs of approximately $300,000. The sales price was payable in cash of
approximately $324,000 (approximately 231,000 Euros) and $5,865,000 in debt from Drew. The seller
provided financing is collateralized by certain assets of Biocode. Biocode assets were vertically
integrated into the Companys clinical diagnostics business that includes Drew and JAS. The
seller-provided financing, which is guaranteed by the Company, requires payment over four years as
follows:
| the first interest-only payment was due in December of 2009 at an annual interest rate of 7%; this payment has not yet paid due to an agreement reached with the seller; | ||
| thereafter, every nine months after June 30, 2010, an interest payment is due at an annual interest rate of 7%; | ||
| June 30, 2010 a principal payment of Euro 800,000 was made; | ||
| June 30, 2011 a principal payment of Euro 1,000,000 is due; | ||
| December 31, 2011 a principal payment of Euro 1,000,000 is due; and | ||
| December 31, 2012 a principal payment of Euro 1,375,000 is due. |
The payment amount in United States Dollars will be determined on the payment due date,
based upon the then current exchange rate between the United States Dollar and the Euro.
After evaluating the Biocode Hycel transaction, the Company concluded that the assets
purchased lacked certain key components necessary to categorize the transaction as a purchase of a
business as defined by EITF 98-3 These key missing components included:
Employees essential to continue to conduct normal operations were not transferred to
Biocode Hycel. Key employees remained with the IDS (seller) to continue to operate the
remaining components of their company. These key missing skills include chemists with hematology
background, quality control personnel, senior management and administrative personnel.
Access to customers that would buy the outputs of the transferred set is limited. Since the
Company only purchased certain assets of the seller , both the Company and the seller will attempt
to sell outputs to the same customers. The customers of the seller bought both hematology
products (now the out put of Biocode Hycel) and biochemistry products still produced by the seller
. It will take time for the customers to adjust to this new arrangement.
Business processes essential to conducting normal operations were not fully transferred. The
manufacturing, accounting and administrative processes of the seller commingled all of the various
out puts that the seller produced. Because of this limited transfer no discrete processes were in
place to manage and account for the activities of the transferred set. These accounting and
administrative functions need to be implemented from scratch. This process includes the seller
and Biocode working closely to bifurcate the transferred set from the elements retained by the
seller . Other critical senior management, accounting and administrative functions not included in
the transferred set are currently being performed outside of the transferred set by employees of
Biocodes parent until these functions can be put in place.
The Company has concluded that the cost, time frame and level of effort required to implement
the missing elements taken as a whole are more than minor, therefore, the transaction constituted
the purchase of certain assets and not the purchase of a business.
64
The following table summarizes the purchase price allocation of estimated fair values of
assets acquired as of December 31, 2008, the date of acquisition.
Current Assets |
$ | 3,961,564 | ||
Fixed Assets |
50,619 | |||
Patents and other intangible assets |
2,198,596 | |||
Total |
$ | 6,210,779 | ||
JAS Diagnostics, Inc. Acquisition
On May 29, 2008 Drew acquired the stock of JAS for $2,100,000 less assumed liabilities of
$127,975. The sales price was payable 33% in cash and 67% (see footnote 6) in debt from Drew to
three of the JAS shareholders and 100% cash for the remaining two JAS shareholders. JAS provides
design, development, validation and manufacturing services for vitro diagnostic chemistry reagents
to there customers. The operating results of JAS are included as part of the Drew business segment
as of May 30, 2008.
The Company accounted for the purchase under SFAS 141. Under FASB issued authoritative
guidance, the Company paid a premium (i.e., goodwill) over the fair value of the net tangible and
identified intangible assets acquired to obtain a leading edge technology platform in the digital
imaging marketplace. The application of purchase accounting under FAS 141 requires that the total
purchase price be allocated to the fair value of assets acquired and liabilities assumed based on
their fair values at the acquisition date, with amounts exceeding the fair values being recorded as
goodwill in the amount of $93,181. The allocation process requires an analysis of acquired fixed
assets, contracts, customer lists and relationships, trademarks, patented technology, service
markets, contractual commitments, legal contingencies and brand value to identify and record the
fair value of all assets acquired and liabilities assumed.
The following table summarizes the purchase price allocation of estimated fair values of
assets acquired and liabilities assumed as of the date of acquisition of JAS as of May 30, 2008.
Current assets |
$ | 420,981 | ||
Furniture and equipment |
35,441 | |||
Trade Name |
89,000 | |||
Customer list |
1,461,397 | |||
Goodwill |
93,181 | |||
Total assets acquired |
2,100,000 | |||
Current liabilities |
127,975 | |||
Net assets acquired |
$ | 1,972,025 | ||
65
15. Segment Reporting
The Companys continuing operations are classified into four principal reporting segments for
2010, 2009 and 2008. On April 30, 2010, certain assets of Vascular Access were sold for
$5,750,000, see footnote 13 for additional information.
Table amounts in thousands:
Segment Statements of Operations (in thousands) Year ended June 30,
Drew | Sonomed | |||||||||||||||||||||||
2010 | 2009 | 2008 | 2010 | 2009 | 2008 | |||||||||||||||||||
Revenues, net: |
||||||||||||||||||||||||
Product revenue |
$ | 19,403 | $ | 18,085 | $ | 13,332 | $ | 8,055 | $ | 9,175 | $ | 9,367 | ||||||||||||
Other revenue |
985 | 133 | 222 | | | | ||||||||||||||||||
Total revenue, net |
20,388 | 18,218 | 13,554 | 8,055 | 9,175 | 9,367 | ||||||||||||||||||
Costs and expenses: |
||||||||||||||||||||||||
Cost of goods sold |
11,137 | 11,207 | 8,928 | 4,558 | 4,974 | 5,029 | ||||||||||||||||||
Marketing, General & Admin |
11,843 | 7,090 | 5,287 | 2,384 | 3,247 | 3,824 | ||||||||||||||||||
Research & Development |
957 | 1,800 | 2,745 | 560 | 1,085 | 779 | ||||||||||||||||||
Goodwill Impairment |
| | 9,575 | | 9,526 | | ||||||||||||||||||
Total costs and expenses |
23,937 | 20,097 | 26,535 | 7,502 | 18,832 | 9,632 | ||||||||||||||||||
(Loss) income from
operations |
(3,549 | ) | (1,879 | ) | (12,981 | ) | 553 | (9,657 | ) | (265 | ) | |||||||||||||
Other (expense) and
income: |
||||||||||||||||||||||||
Gain (loss) on sale of assets |
| 92 | | | | | ||||||||||||||||||
Equity in OTM |
| | | | | | ||||||||||||||||||
Interest income |
| | | | | | ||||||||||||||||||
Interest expense |
(416 | ) | (216 | ) | (12 | ) | | | | |||||||||||||||
Total other (expense) and
income |
(416 | ) | (124 | ) | (12 | ) | | | | |||||||||||||||
Income from continuing operations |
(3,965 | ) | (2,003 | ) | (12,993 | ) | 553 | (9,657 | ) | (265 | ) | |||||||||||||
Net gain from discontinued operation |
| | | | | | ||||||||||||||||||
Income taxes |
| | | | | 26 | ||||||||||||||||||
Net (loss) income |
$ | (3,965 | ) | $ | (2,003 | ) | $ | (12,993 | ) | $ | 553 | $ | (9,657 | ) | $ | (291 | ) | |||||||
66
Segment Statements of Operations (in thousands) Year ended June 30, | ||||||||||||||||||||||||||||||||||||
EMI | Medical/Trek | Total | ||||||||||||||||||||||||||||||||||
2010 | 2009 | 2008 | 2010 | 2009 | 2008 | 2010 | 2009 | 2008 | ||||||||||||||||||||||||||||
Revenues, net: |
||||||||||||||||||||||||||||||||||||
Product revenue |
$ | 1,902 | $ | 2,078 | $ | 1,762 | $ | 1,297 | $ | 1,262 | $ | 1,410 | $ | 30,657 | $ | 30,600 | $ | 25,871 | ||||||||||||||||||
Other revenue |
| | | | | | 985 | 133 | 222 | |||||||||||||||||||||||||||
Total revenue, net |
1,902 | 2,078 | 1,762 | 1,297 | 1,262 | 1,410 | 31,642 | 30,733 | 26,093 | |||||||||||||||||||||||||||
Costs and expenses: |
||||||||||||||||||||||||||||||||||||
Cost of goods sold |
866 | 1,069 | 820 | 881 | 848 | 995 | 17,442 | 18,098 | 15,772 | |||||||||||||||||||||||||||
Marketing, General & Admin |
744 | 774 | 605 | 721 | 1,957 | 2,699 | 15,692 | 13,061 | 12,415 | |||||||||||||||||||||||||||
Research & Development |
361 | 362 | 268 | 16 | 9 | 6 | 1,894 | 3,256 | 3,798 | |||||||||||||||||||||||||||
Goodwill Impairment |
| | | | | | | 9,526 | 9,575 | |||||||||||||||||||||||||||
Total costs and expenses |
1,971 | 2,205 | 1,693 | 1,618 | 2,814 | 3,700 | 35,028 | 43,941 | 41,560 | |||||||||||||||||||||||||||
(Loss) income from operations |
(69 | ) | (127 | ) | 69 | (321 | ) | (1,552 | ) | (2,290 | ) | (3,386 | ) | (13,208 | ) | (15,467 | ) | |||||||||||||||||||
Other (expense) and
income: |
||||||||||||||||||||||||||||||||||||
Gain on sale of assets |
| | | | | 92 | | |||||||||||||||||||||||||||||
Equity in OTM |
| | | (75 | ) | (65 | ) | (88 | ) | (75 | ) | (65 | ) | (88 | ) | |||||||||||||||||||||
Interest income |
| | | | 19 | 299 | | 19 | 299 | |||||||||||||||||||||||||||
Interest expense |
(10 | ) | | | | | | (426 | ) | (216 | ) | (12 | ) | |||||||||||||||||||||||
Total other
(expense) and income |
(10 | ) | | | (75 | ) | (46 | ) | 211 | (501 | ) | (170 | ) | 199 | ||||||||||||||||||||||
Income from continuing operations |
(79 | ) | (127 | ) | 69 | (396 | ) | (1,598 | ) | (2,079 | ) | (3,887 | ) | (13,385 | ) | (15,268 | ) | |||||||||||||||||||
Net gain from discontinued operations |
| | | | | | 3,474 | 413 | 344 | |||||||||||||||||||||||||||
Income taxes |
| | | | | 109 | | | 135 | |||||||||||||||||||||||||||
Net (loss) income |
$ | (79 | ) | $ | (127 | ) | $ | 69 | $ | (396 | ) | $ | (1,598 | ) | $ | (2,188 | ) | $ | (413 | ) | $ | (12,965 | ) | $ | (15,059 | ) | ||||||||||
The Company operates in the healthcare market, specializing in the development,
manufacture and marketing of (1) ophthalmic medical devices and pharmaceuticals; (2) in-vitro
diagnostic (IVD) instrumentation and consumables for use in human and veterinary hematology. On
April 30, 2010, the Company sold its Vascular business. The business segments reported above are
the segments for which separate financial information is available and for which operating results
are evaluated regularly by executive management in deciding how to allocate resources and assessing
performance. The accounting policies of the business segments are the same as those described in
the summary of significant accounting policies. For the purposes of this illustration, corporate
expenses, which consist primarily of executive management and administrative support functions, are
allocated across the business segments based upon a methodology that has been established by the
Company, which includes a number of factors and estimates and that has been consistently applied
across the business segments. These expenses are otherwise included in the Medical/Trek business
unit.
During the fiscal years ended June 30, 2010, 2009 and 2008, Drew derived its revenue from the
sale of instrumentation and consumables for blood cell counting and blood analysis in the areas of
diabetes, cardiovascular diseases and human and veterinary hematology. Sonomed derived its revenue
from the sale of A-Scans, B-Scans and pachymeters. These products are used for diagnostic or
biometric applications in ophthalmology. These products are used by medical personnel to assist in
gaining access to arteries and veins in difficult cases. Medical/Trek derived its revenue from
the sale of ISPAN gas products and various disposable ophthalmic surgical products. EMI derived
its revenue from CFA digital imaging systems and related products.
No customer represented more than 10% of consolidated revenue from continuing operations
for the years ended June 30, 2010, 2009 and 2008. Of the external revenue reported above, the
following amounts were derived internationally during the years ended
June 30:
67
2010 | 2009 | 2008 | ||||||||||
Drew |
$ | 11,787,155 | $ | 9,417,050 | $ | 6,587,050 | ||||||
Sonomed |
4,398,961 | 5,931,351 | 5,858,763 | |||||||||
EMI |
| 42,300 | 53,700 | |||||||||
Medical/Trek |
0 | 23,954 | 31,864 | |||||||||
$ | 16,186,116 | $ | 15,414,655 | $ | 12,531,377 | |||||||
16. Related-Party Transactions
Escalon and a member of the Companys Board of Directors are founding and equal members of
Ocular Telehealth Management, LLC (OTM). OTM is a diagnostic telemedicine company providing
remote examination, diagnosis and management of disorders affecting the human eye. OTMs initial
solution focuses on the diagnosis of diabetic retinopathy by creating access and providing annual
dilated retinal examinations for the diabetic population. OTM was founded to harness the latest
advances in telecommunications, software and digital imaging in order to create greater access and
a more successful disease management for populations that are susceptible to ocular disease.
Through June 30, 2010, Escalon had invested $399,000 in OTM and owned 45% of OTM. The Company
provides administrative support functions to OTM. For the years ended 2010, 2009 and 2008 the
Company recorded losses of $74,911, $65,387, and $88,206, respectively.
Richard J.
DePiano, Sr., the Companys Chief Executive Officer. participated in an accounts receivable factoring program that was implemented
by the Company. Under the program, Mr. DePiano advanced the Company $157,332 which represented 80% of an amount due from a Drew customer
in Algeria, as of June 30, 2010 the entire amount of the receivable
was collected. The receivable from Algeria, was not eligible
to be sold to the Companys usual factoring agent. Interest on the transaction is 1.75% per month, which is equal to the best price
offered by the Companys usual factoring agent. The transaction excluded fees typically charged by the factoring agent and provided
much needed liquidity to the Company. Mr. DePiano was paid back in
full and was paid $6,351 in
interest on the transaction during the year ended June 30, 2010.
17. Fair Value Measurements
On July 1, 2008, the Company adopted the FASB-issued authoritative guidance for the fair value
of financial assets and liabilities. This standard defines fair value and establishes a hierarchy
for reporting the reliability of input measurements used to assess fair value for all assets and
liabilities. The FASB issued authoritative guidance defines fair value as the selling price that
would be received for an asset, or paid to transfer a liability, in the principal or most
advantageous market on the measurement date. The hierarchy established prioritizes fair value
measurements based on the types of inputs used in the valuation technique. The inputs are
categorized into the following levels:
Level 1 Observable inputs such as quoted prices in active markets for identical assets or
liabilities
Level 2 Directly or indirectly observable inputs for quoted and other than quoted prices
for identical or similar assets and liabilities in active or non-active markets
Level 3 Unobservable inputs not corroborated by market data, therefore requiring the
entity to use the best available information available in the circumstances, including the
entitys own data.
Certain financial instruments are carried at cost on the condensed consolidated balance
sheets, which approximates fair value due to their short-term, highly liquid nature. These
instruments include cash and cash equivalents, accounts receivable, accounts payable and accrued
expenses and other liabilities.
The Company determined that the fair value of the outstanding debt approximates their
outstanding balances based on the remaining short term maturity of the note for JAS and the Biocode
Hycel debt acquired in May 2008 and December 2008, respectively, and other Level 3 measurements.
The Company determined the estimated fair value amounts by using available market information and
commonly accepted valuation methodologies. However, considerable judgment is required in
interpreting market data as well as the risk of nonperformance related to the debt to develop
estimates of fair value. The
use of different assumptions and/or estimation methodologies may have a material effect on the
estimated fair values.
68
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 Companys management evaluated, with the
participation of the Companys principal executive officer and
principal financial officer, the effectiveness of the Companys
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 Companys principal
executive officer and principal financial officer concluded
that the Companys disclosure controls and procedures are
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 SECs rules and forms and is accumulated and communicated
to our management, including the Companys principal executive
officer and principal financial officer, as appropriate to
allow timely decisions regarding required disclosure.
Managements Report on Internal Control over Financial Reporting
The Companys 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 Companys 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 Companys assets; | ||
| Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that the Companys receipts and expenditures are being made only in accordance with authorizations of the Companys management and directors; and | ||
| Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Companys assets that could have a material affect on our financial statements. |
As of the end of the period covered by
this Annual Report on Form 10-K, the Companys management
evaluated, with the participation of its principal executive
officer and principal financial officer, the effectiveness of
the Companys internal control over financial reporting. This
evaluation was conducted using the framework in Internal
ControlIntegrated Framework issued by the Committee of
Sponsoring Organizations of the Treadway Commission. Based upon
that evaluation, the Companys management concluded that its
internal control over financial reporting was effective as of
June 30, 2010.
Pursuant to the rules of the SEC, the Companys
managements 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
69
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 Companys independent registered public
accounting firm regarding our internal control over financial
reporting. The Companys managements report on internal
control over financial reporting was not subject to attestation
by the Companys independent registered public accounting firm
pursuant to temporary rules of the Securities and Exchange
Commission that permit us to provide only the Companys
managements 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 2010 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
Item 10 will be provided by incorporating the information required under such item by
reference to the Companys Proxy Statement to be filed with the SEC no later than 120 days after
the end of the fiscal year covered by this Form 10-K annual report, or, alternatively, by amendment
to this Form 10-K annual report under cover of Form 10-K/A no later than the end of such 120-day
period.
ITEM 11. EXECUTIVE COMPENSATION
Item 11 will be provided by incorporating the information required under such item by
reference to the Companys Proxy Statement to be filed with the SEC no later than 120 days after
the end of the fiscal year covered by this Form 10-K annual report, or, alternatively, by amendment
to this Form 10-K annual report under cover of Form 10-K/A no later than the end of such 120-day
period.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Item 12 will be provided by incorporating the information required under such item by
reference to the Companys Proxy Statement to be filed with the SEC no later than 120 days after
the end of the fiscal year covered by this Form 10-K annual report, or, alternatively, by amendment
to this Form 10-K annual report under cover of Form 10-K/A no later than the end of such 120-day
period.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
Item 13 will be provided by incorporating the information required under such item by
reference to the Companys Proxy Statement to be filed with the SEC no later than 120 days after
the end of the fiscal
70
year covered by this Form 10-K annual report, or, alternatively, by amendment
to this Form 10-K annual report under cover of Form 10-K/A no later than the end of such 120-day
period.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
Item 14 will be provided by incorporating the information required under such item by
reference to the Companys Proxy Statement to be filed with the SEC no later than 120 days after
the end of the fiscal year covered by this Form 10-K annual report, or, alternatively, by amendment
to this Form 10-K annual report under cover of Form 10-K/A no later than the end of such 120-day
period.
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(a) Documents Filed as Part of This Annual Report on Form 10-K:
(1) 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
Consolidated Balance Sheets as of June 30, 2010 and 2009
Consolidated Statements of Operations for the years ended June 30, 2010, 2009 and
2008
Consolidated Statements of Shareholders Equity and Comprehensive Loss for the
years ended June 30, 2010, 2009 and 2008
Consolidated Statements of Cash Flows for the years ended June 20, 2010, 2009 and
2008
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 our 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, which 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.
3.1 |
(a) | Restated Articles of Incorporation of Registrant. (8) | ||
(b) | Agreement and Plan of Merger dated as of September 28, 2001 between Escalon Pennsylvania, Inc. and Escalon Medical Corp. (8) | |||
3.2 |
Bylaws of Registrant. (8) | |||
4.5 |
(a) | Warrant Agreement between Registrant and U.S. Stock Transfer Corporation. (1) | ||
(b) | Amendment to Warrant Agreement between the Registrant and U.S. Stock Transfer Corporation. (2) |
71
(c) | Amendment to Warrant Agreement between the Registrant and American Stock Transfer Corporation. (3) | |||
4.6
|
Securities Purchase Agreement, dated as of December 31, 1997 by and among the Registrant and Combination. (4) | |||
4.7
|
Registration Rights Agreement, dated as of December 31, 1997 by and among the Registrant and Combination. (4) | |||
4.8
|
Warrant to Purchase Common Stock issued December 31, 1997 to David Stefansky. (4) | |||
4.9
|
Warrant to Purchase Common Stock issued December 31, 1997 to Combination. (4) | |||
4.10
|
Warrant to Purchase Common Stock issued December 31, 1997 to Richard Rosenblum. (4) | |||
4.11
|
Warrant to Purchase Common Stock issued December 31, 1997 to Trautman, Kramer & Company. (4) | |||
10.6
|
Employment Agreement between the Registrant and Richard J. DePiano dated May 12, 1998. (6)** | |||
10.7
|
Non-Exclusive Distributorship Agreement between Registrant and Scott Medical Products dated October 12, 2000. (9) | |||
10.9
|
Assets Sale and Purchase Agreement between the Registrant and Endologix, Inc. dated January 21, 1999. (5) | |||
10.13
|
Supply Agreement between the Registrant and Bausch & Lomb Surgical, Inc. dated August 13, 1999. (5) | |||
10.15
|
Registrants Amendment and Supplement Agreement and Release between the Registrant and Endologix, Inc. dated February 28, 2001. (10) | |||
10.29
|
Registrants amended and restated 1999 Equity Incentive Plan. (13) ** | |||
10.30
|
Securities Purchase Agreement dated as of March 16, 2004 (the Securities Purchase Agreement) between the Company and the Purchasers signatory thereto. (14) | |||
10.31
|
Registration Rights Agreement dated as of March 16, 2004 between the Company and the Purchasers signatory thereto. (14) | |||
10.32
|
Form of Warrant to Purchase Common Stock issued to each Purchaser under the Securities Purchase Agreement. (14) | |||
10.33
|
Manufacturing Supply and Distribution Agreement between Sonomed, Inc. and Ophthalmic Technologies, Inc. dated as of March 11, 2004. (15) | |||
10.34
|
Supplemental Executive Retirement Benefit Agreement for Richard DePiano dated June 23, 2005. (16)** | |||
10.36
|
Vascular Access Sales Agreement dated April 30, 2010. (17) | |||
21
|
Subsidiaries. (11) | |||
23.1
|
Consent of Independent Registered Public Accounting Firm (*). | |||
31.1
|
Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002 (*). | |||
31.2
|
Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002 (*). | |||
32.1
|
Certification of the Chief Executive Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002 (*). | |||
32.2
|
Certification of the Chief Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002 (*). |
* | Filed herewith. | |
** | Management contract of compensatory plan. |
72
(1) | Filed as an exhibit to Pre-Effective Amendment No. 2 to the Companys Registration Statement on Form S-1 dated November 9, 1993 (Registration No. 33-69360). | |
(2) | Filed as an exhibit to the Companys Form 10-KSB for the year ended June 30, 1994. | |
(3) | Filed as an exhibit to the Companys Form 10-KSB for the year ended June 30, 1995. | |
(4) | Filed as an exhibit to the Companys Registration Statement on Form S-3 dated January 20, 1998 (Registration No. 333-44513). | |
(5) | Filed as an exhibit to the Companys Form 10-KSB for the year ended June 30, 1999. | |
(6) | Filed as an exhibit to the Companys Form 8-K/A, dated March 31, 2000. | |
(7) | Filed as an exhibit to the Companys Registration Statement on Form s-* dated February 25, 2000 (Registration No. 333-31138). | |
(8) | Filed as an exhibit to the Companys Proxy Statement on Schedule 14A, as filed by the Company with the SEC on September 21, 2001. | |
(9) | Filed as an exhibit to the Companys Form 10-KSB for the year ended June 30, 2001. | |
(10) | Filed as an exhibit to the Companys Form 10-Q for the quarter ended March 31, 2001. | |
(11) | Filed as an exhibit to the Companys Form 10-KSB/A for the year ended June 30, 2002. | |
(12) | Filed as an exhibit to the Companys Form 10-Q for the quarter ended December 31, 2002. | |
(13) | Filed as an exhibit to the Companys Form 10-Q for the quarter ended December 31, 2003. | |
(14) | Filed as an exhibit to the Companys Registration Statement on Form S-3 dated April 8, 2004 (Registration No. 333-114332). | |
(15) | Filed as an exhibit to the Companys Form 10-Q for the quarter ended March 31, 2004. | |
(16) | Filed as an exhibit to the Companys Form 8-K, dated June 23, 2005. | |
(17) | Filed as an exhibit to the Companys Form 8-K, dated May 6, 2010. |
Signatures
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.
Escalon Medical Corp. (Registrant) |
||||
By: | /s/ Richard J. DePiano | |||
Richard J. DePiano | ||||
Chairman and Chief Executive Officer | ||||
Dated:
October 12, 2010
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.
By:
|
/s/ Richard J. DePiano
|
Chairman and Chief Executive Officer (Principal Executive Officer) and Director |
October 12, 2010 | |||||
By:
|
/s/ Robert M. OConnor
|
Chief Financial Officer (Principal Financial and Accounting Officer) |
October 12, 2010 | |||||
By:
|
/s/ Anthony Coppola
|
Director | October 12, 2010 |
73
By: |
/s/ Jay L. Federman
|
Director | October 12, 2010 | |||||
By:
|
/s/ William L.G. Kwan
|
Director | October 12, 2010 | |||||
By:
|
/s/ Lisa Napolitano
|
Director | October 12, 2010 | |||||
By:
|
/s/ Fred Choate
|
Director | October 12, 2010 |
74