ESCALON MEDICAL CORP - Annual Report: 2008 (Form 10-K)
Table of Contents
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, 2008
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 incorporation or organization) |
(I.R.S. Employer 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 a 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 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 o No þ
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 (Do not check if a smaller reporting company) | Smaller reporting company þ |
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, 2007, was approximately $22,833,590, 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 25, 2008, there were 6,413,930 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 2008 Annual
Meeting of Shareholders.
Escalon Medical Corp.
Annual Report on Form 10-K
For the Fiscal Year Ended June 30, 2008
Annual Report on Form 10-K
For the Fiscal Year Ended June 30, 2008
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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, Inc. (Drew)
and its subsidiaries. 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 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, blood analysis and blood
chemistry. 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.
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, whereas the
Hemavet product line is for use in the veterinary field.
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.
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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 of 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 do 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.
Vascular Business
Vascular
develops, manufactures and markets assisted vascular access products. These products are
Doppler-guided vascular access assemblies used to locate desired vessels for access. Primary
specialty groups that use the device are cardiac catheterization labs and interventional
radiologists. The Companys vascular products include the PD Access and SmartNeedle lines of
monitors, Doppler-guided bare needles and Doppler-guided infusion needles.
PD Access and SmartNeedle Monitors, Needles and Catheter Products
These devices detect blood flow using Doppler ultrasound technology and differentiate between
a venous and arterial vessel. The devices utilize a miniature Doppler ultrasound probe that is
positioned within the lumen of a vascular access needle. When a Doppler-guided needle pierces the
skin of a patient, the probe and monitor can determine if the user is approaching an artery or
vein, guiding them to a successful vascular access.
VascuView
Visual Ultrasound System
This
device provides a two-dimensional B-Scan image of the vasculature of
a patient, thereby allowing a user to visually guide a needle to the
desired artery or vein for access. Vascular provides periphery
consumable products to maintain a sterile field when using the device.
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. On January 30, 2006 EMI acquired substantially all of the assets of MRP
Group, Inc. (MRP) in exchange for 250,000 shares of the Companys common stock and approximately
$47,000 in cash. The MRP business consists of ophthalmic technology solutions offering retinal
imaging systems. The operating results of MRP are included as part of the EMI business unit
as of January 30, 2006.
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Medical/Trek Business
Medical/Trek manufactures and distributes the following ophthalmic surgical products under the
Companys and/or Trek Medical Products names. Vitreoretinal ophthalmic surgeons primarily utilize
these 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
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. Silicon Oil refers to Adatosil® 5000 Silicone Oil, whose license of distribution rights
were sold to Bausch & Lomb Surgical, Inc. Pursuant to that agreement, the Company has not received
any revenue from Silicon Oil since August 2005.
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, Oxford, Connecticut and Barrow-in-Furness, United Kingdom facilities. The Company
conducts medical device and vascular access product development at its New Berlin, Wisconsin
facility located near Milwaukee. 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 for the fiscal years ended June 30, 2008, 2007 and 2006 were approximately
$4,058,000, $3,461,000 and $2,828,000, respectively.
Manufacturing and Distribution
The Company leases an aggregate of approximately 42,000 square feet of space at its facilities
in Texas, Connecticut and the United Kingdom. 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 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 approximately 11,200 square feet of space in New Berlin, Wisconsin, near
Milwaukee, for its surgical products and vascular access operations. The facility is currently
used for engineering, product design and development, manufacturing and product assembly. The
Company also leases approximately 2,500 square feet in Lawrence, Massachusetts used primarily for
product design and development in the EMI business unit. The Company subcontracts component
manufacture, assembly and
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sterilization to various vendors. The New Berlin manufacturing facility includes a class
10,000 clean room. A class 10,000 clean room is a controlled environment for producing devices
while avoiding any significant contaminants. The cleanliness provided by the clean room exceeds
the requirements of the FDA. The Companys ophthalmic surgical products and vascular access
products are distributed from the Companys Wisconsin facility.
The Company designs, develops and services its ultrasound ophthalmic products at its
approximately 12,200 square foot facility in Lake Success, New York. The Company has achieved
ISO9001 certification at all of its manufacturing facilities for all medical devices, ultrasound
devices and consumables the Company produces. ISO9001 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.
The manufacture, testing and marketing of each of the Companys products entails risk of
product liability. Product liability insurance is carried by the Company 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 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, however, some foreign countries may require separate individual foreign regulatory
clearances.
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Marketing and Sales
The Drew business unit sells its products through internal sales and marketing employees
located in the United States 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.
Vascular business unit products are marketed domestically through internal sales and marketing
employees located in the United States as well as through an independent sales representative in
Europe and a network of domestic and foreign distributors that are managed by the Companys sales
team.
The Medical/Trek and EMI business units 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.
Third Party Reimbursement
It is expected that physicians and hospitals will purchase certain of the Companys products
and that they in turn will bill various third party payers for health care services provided to
their patients using these products. These payors include Medicare, Medicaid and private insurers.
Government agencies generally reimburse health care providers at a fixed rate based on the
procedure performed. Third party payors may deny reimbursement if they determine that a procedure
performed using any one of the Companys products was unnecessary, inappropriate, not
cost-effective, experimental or used for a non-approved indication.
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 21 United States patents and 19 patents issued abroad that
cover the Companys surgical products and pharmaceutical technology.
With respect to the Companys ultrafast laser technology, licensed to Intralase Corp.
Intralase, 16 patents have been issued in the United States and 11 overseas. In 1997, Intralase
and Escalon entered into an agreement under which Intralase became the exclusive licensee of these
patents, technology and intellectual property owned by the Company, which agreement was amended and
restated
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in October 2000. On February 27, 2007, the Company settled all outstanding disputes and litigation
with Intralase pursuant to which the Company transferred to Intralase its ownership of all patents
and intellectual property formerly licensed to Intralase, the license agreement was terminated and
Intralase made a lump-sum payment to the Company of $9,600,000.
Drew has approximately 60 patents related to its technology.
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 are the following:
| The Escalon trademark is due for renewal on January 19, 2013, and the Company intends to renew the trademark. The Sonomed trademark was renewed on November 25, 2006. | ||
| In the Vascular business unit, the Company has two patents that are of material importance. The first patent is an apparatus for the cannulation of blood vessels. This patent will expire on February 23, 2011. The second patent is also an apparatus for the cannulation of blood vessels. This patent will expire on January 11, 2009. The Vascular unit has also one patent application pending for the cannulation of blood vessels with a hypodermic needle. |
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
(such as contact lens cleaning solution) 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.
Management believes that Sonomed is in a market leadership position. 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. Sonomed seeks to preserve its position in the market through continued product
enhancement. Various competitors offering similar products at a lower price could threaten
Sonomeds market position. The development of laser technologies for ophthalmic biometrics and
imaging 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.
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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.
The Vascular access product line is comprised of disposable devices, and currently Vascular
has no direct competition. However, a significantly higher priced non-disposable device that
facilitates vascular access is currently being marketed. Vascular produces the only device that
can be accommodated within a standard needle for assisting medical practitioners in gaining access
to a vessel in the human vascular system. There are no similar devices on the market that enable
medical practitioners to gain access using their normal procedures. The only similar product
utilizes a separate ultrasound monitor, but no disposables are utilized. When using the competing
device, medical practitioners need to look at the monitor while advancing the needle into the
patient. The perceived disadvantage of the Companys vascular product is that the retail price is
substantially greater than the cost of a traditional needle.
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, 2008, the Company employed 150 full-time employees and 11 part-time employees.
70 of the Companys employees are employed in manufacturing, 45 are employed in general and
administrative positions, 23 are employed in sales and marketing and 23 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
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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 such
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 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:
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 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 acquired Drew during the first quarter of fiscal 2005. Drew does not have a
history of producing positive operating cash flows and, as a result, at the time of acquisition,
was operating under financial constraints and was under-capitalized and has continued to negatively
impact the Companys financial results. As Drew is integrated into the Company, management
continues to work to reverse the situation, while at the same time seeking to strengthen Drews
market position. The Company loaned approximately $20 million to Drew. The funds have been
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. 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 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.
As a result of this years test, the Company recorded a non-cash goodwill impairment charge to
Drews operations totaling $9,574,655 for the year ended June 30, 2008 (see footnote 3 of the
consolidated financial statements. 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 unit,
including profit margins, long-term forecasts, discount rates and terminal growth rates, reflect
the Companys best estimates.
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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 and JAS, and subsequent integration of the acquired company, although such acquisitions may not occur; | ||
| 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.
The Companys Cost Saving Initiatives may not be effective.
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.
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
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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 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 competitive products 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; |
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| 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 cannot ensure that the Company will 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.
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
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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 $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.
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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:
| Any 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.
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
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assumptions for assessing the recoverability of the Companys goodwill and other intangible
assets, pursuant to Statement of Financial Accounting Standards, or SFAS, No. 142, Goodwill and
Other Intangible Assets, and SFAS No. 144, Accounting for the Impairment or Disposal of Long-Lived
Assets. 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 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.
The Company will be exposed to risks relating to evaluations of internal control over
financial reporting required by Section 404 of the Sarbanes-Oxley Act of 2002.
The Company anticipates spending a substantial amount of management time and resources to
comply with changing laws, rules, regulations and standards relating to corporate governance and
public disclosure, including the Sarbanes-Oxley Act of 2002 and regulations promulgated by the SEC.
Under the current and proposed rules and regulations of the SEC, the Company is currently not
required to comply with all of the requirements of Section 404 of the Sarbanes-Oxley Act of 2002
until the Company files its Annual Report on Form 10-K for the Companys fiscal year ending June
30, 2010, as long as the Company continues to meet the definition of a non-accelerated filer. In
the Companys Annual Report on Form 10-K for the year ending June 30, 2008, the Companys
management is required to provide an assessment as to the effectiveness of the Companys internal
control over financial reporting, which assessment will be deemed furnished to rather than filed
with the SEC. In the Companys Annual Report on Form 10-K for the year ending June 30, 2010 and for
each fiscal year thereafter, the Companys management will be required to provide an assessment as
to the effectiveness of our internal control over financial reporting and the Companys independent
registered public accounting firm will be required to provide an attestation as to the Companys
managements assessment, which assessment and attestation
will be filed with the SEC. The assessment and attestation processes required by Section 404 are
relatively new to the Company. Accordingly, the Company may encounter problems or delays in
completing its
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obligations and receiving an unqualified report on the Companys internal control
over financial reporting by the Companys independent registered public accounting firm.
While the Company believes that it will be able to timely meet the Companys obligations under
Section 404 and that the Companys management will be able to certify as to the effectiveness of
the Companys internal control over financial reporting, there is no assurance that the Company
will be able to do so. If the Company is unable to timely comply with Section 404, the Companys
management is unable to certify as to the effectiveness of the Companys internal control over
financial reporting or the Companys independent registered public accounting firm is unable to
attest to that certification, the price of the Companys common stock may be adversely affected.
Even if the Company timely meets the certification and attestation requirements of Section 404, it
is possible that the Companys independent registered public accounting firm will advise the
Company that they have identified significant deficiencies and/or material weaknesses, which may
also adversely affect the price of our common stock.
Substantially all of our cash and cash equivalents and marketable securities 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.
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 approximately 71,000 square feet of space for its
(i) corporate offices in Wayne, Pennsylvania, (ii) Drew has an administrative office and
manufacturing facility in Barrow-in-Furness, United Kingdom, an administrative office and
manufacturing facility in Dallas, Texas, and a manufacturing facility in Oxford, Connecticut and
Miami, Florida (JAS). (iii) Sonomed has a manufacturing facility in Lake Success, New York, and
(iv) Vascular has a manufacturing facility in New Berlin, Wisconsin. The corporate offices in
Pennsylvania cover approximately 6,000 square feet and expire in July 2013. The facility in the
United Kingdom covers approximately 8,000 square feet whose lease expires in September 2009. The
facility in Texas covers approximately 23,000 square feet whose lease expires in March 2014. The
Connecticut facility lease covers approximately 3,000 square feet and expires in January 2009. The
Miami facility lease covers approximately 8,000 square feet and expires in July 2009. The New York
facility leases covering approximately 12,000 square feet, expires in October 2011. The Wisconsin
lease, covering approximately 11,000 square feet of space expires in July 2015. Annual rent under
all of the Companys lease arrangements was approximately $782,000.
ITEM 3. | LEGAL PROCEEDINGS |
PointCare Technologies, Inc.
On February 13, 2008, Escalons wholly owned subsidiary, Drew Scientific (Drew), filed an
Order to Show Cause for Preliminary Injunction and Temporary Restraining Order and a Complaint
against PointCare Technologies, Inc. (PCT) (Drew Scientific, Inc. v. PointCare Technologies,
Inc. (08 CV 1490, S.D.N.Y)). In its pleadings, Drew petitioned the Court to require PCT to
honor its obligations to Drew under the Agreement that the parties executed in June 2006 and
further sought a ruling that PCT has
breached its contractual obligations to Drew, that PCT has intentionally acted in bad faith,
and that PCT is liable to Drew for damages resulting from its breach of its contractual obligations
to Drew. PCT has denied
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the allegations set forth by Drew and has asked the Court to declare that
PCT properly terminated its Agreement with Drew and that it owes no further duties and has no
further obligations to Drew.
The Agreement between Drew and PCT was intended to combine the efforts of the parties in two
significant but related respects. In the first respect, Drew agreed to modify its Excell 22
TM hematology platform to accommodate PCTs proprietary CD4 Lymphocyte Assay, CD4
sure.TM The integrated device is intended for use in the diagnosis of patients with HIV
infection, particularly in a hospital setting. Drew asserts that the development of the device is
a joint responsibility, with both Drew and PCT having allocated responsibilities between them (PCT
being responsible for assuring that the CD4 assay is compatible with the HT instrumentation). Two
different versions of the integrated device, referred to collectively as a high throughput (HT)
platform, are to be marketed and sold by the respective parties in assigned territories. Drew has
thus far invested approximately $1,000,000 in this initiative.
The second significant aspect relates to PCTs Near Patient (NP) platform, which permits
the same type of patient care testing for HIV to be performed locally, i.e., in a non-hospital
environment. Once developed and after receiving required regulatory approvals, PCT agreed to
privately label and sell NP instruments to Drew, which was granted certain product distribution
rights, including the right to be the entity primarily responsible for the marketing and sales of
the NP platform in the United States, the United Kingdom, Europe and much of Asia. Drew has
already invested in NP marketing efforts and lined up potential customers. Important to the
present dispute is the fact that there is a significant technological overlap between the HT and NP
devices, and to some extent, they are competitive. For this reason, the Agreement allocates
territories to the parties and the party designated for a specific territory is primarily
responsible for the marketing and sale of both systems in that assigned territory.
In June 2007, PCT unilaterally shifted its personnel and resources away from the joint
development of the HT instrument, diverting these resources instead to the development of its own
NP instrument. Drew believes that at about this time, PCT also began to solicit its own
distributors to act on its behalf in the Drew territories. PCT received FDA approval to market its
NP instrument in December 2007.
In November 2007, PCT asserted that Drew was not in compliance with its contractual
obligations under the Agreement. Specifically, PCT claimed that Drew was not in compliance with
the HT development timeline. Drew denied this claim, noting that PCTs own conduct contributed
materially to the fact that the HT project timeline had to be extended. Further, Drew responded
that PCTs repeated refusal to complete critical software development and to cooperate with Drew
with respect to the necessary integration of such software into the HT instrument remained critical
violations by PCT of its contractual obligations, frustrating any effort by Drew to complete the HT
project.
Despite Drews attempts to resolve outstanding issues with PCT amicably, PCT informed Drew in
December 2007, shortly after receiving approval of its own NP instrument, that PCT deemed the
Agreement between the parties to be terminated, that PCT would not take the necessary steps to
assist Drew to complete the HT instrument project and that PCT would not allow Drew to market or
sell the NP instrument within the territories that were granted to Drew under the Agreement.
Drew filed its legal actions against PCT in February 2008, alleging that PCTs conduct is
intended to irreparably harm Drews ability to bring the HT instrument into the marketplace and
thus allow PCT to gain a competitive advantage for its NP instrument. Drew further alleges that
PCTs actions are intended to deny Drew the economic benefits associated with its marketing rights
relative to both the HT and NP products. Consequently, Drew claims that PCTs actions have and
will continue to harm its reputation and that in addition to its lost profits, Drew is threatened
with the loss of the significant economic resources that it has already committed to the
development and marketing of both the HT and the NP instrument, as well as other irreparable harm.
After a brief period of discovery and the submission of legal papers, the Court issued a
ruling on May 6, 2008. While denying Drews request for a Preliminary Injunction, the Court
scheduled the dispute for expedited trial. The parties are making
progress on achieving an amicable resolution to this matter. The
parties, therefore, have requested and been granted an indefinite
extension to ascertain if a full and final resolution can be achieved
by the parties.
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The Company is cognizant of the legal expenses and costs associated with the PCT litigation.
The Company, however, believes that Drew is taking all necessary actions to protect its rights and
interests under the Agreement with PCT. The Company believes, however, that it
is necessary to pursue this litigation and possible final resolution: a) to protect the significant R&D expenditure that Drew has
already invested in the development of the HT Instrument; b) to prevent PCT from denying Drew
access to PCTs NP Instrument; c) protect Drews territorial rights, as well as its reputation in
such markets; and d) allow Drew to receive the economic benefits that it is entitled to with
respect to both the HT and NP instruments.
Other 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. | SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS |
No matters were submitted to a vote of security holders during the quarter ended June 30,
2008.
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, 2008 |
||||||||
Quarter ended September 30, 2007 |
$ | 8.60 | $ | 3.95 | ||||
Quarter ended December 31, 2007 |
$ | 5.72 | $ | 2.99 | ||||
Quarter ended March 31, 2008 |
$ | 4.39 | $ | 2.78 | ||||
Quarter ended June 30, 2008 |
$ | 3.40 | $ | 2.86 | ||||
Fiscal year ended June 30, 2007 |
||||||||
Quarter ended September 30, 2006 |
$ | 5.19 | $ | 4.06 | ||||
Quarter ended December 31, 2006 |
$ | 4.19 | $ | 2.35 | ||||
Quarter ended March 31, 2007 |
$ | 4.38 | $ | 2.55 | ||||
Quarter ended June 30, 2007 |
$ | 4.53 | $ | 3.75 |
As of September 20, 2008, there were 4,274 holders of record of the Companys common stock.
On September 19, 2008 the closing price of the Companys Common Stock as reported by the NASDAQ
Capital Market was $2.33 per share.
Escalon 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.
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ITEM 6. | SELECTED FINANCIAL DATA |
The following selected financial data are derived from the consolidated financial statements
of the Company. The data should be read in conjunction with Managements Discussion and Analysis
of Financial Condition and Results of Operations included herein in Item 7 and the financial
statements and related notes to consolidated financial statements thereto included herein in Item
8.
For the Years Ended June 30, | ||||||||||||||||||||
2008 | 2007 | 2006 | 2005 | 2004 | ||||||||||||||||
(Amounts in thousands, except per share amounts) | ||||||||||||||||||||
Statement of Operations Data: |
||||||||||||||||||||
Net revenues: |
||||||||||||||||||||
Product revenue |
$ | 29,988 | $ | 27,893 | $ | 27,544 | $ | 23,864 | $ | 12,348 | ||||||||||
Other revenue |
222 | 10,945 | 2,247 | 3,060 | 2,373 | |||||||||||||||
Revenues, net |
30,210 | 38,838 | 29,791 | 26,924 | 14,721 | |||||||||||||||
Costs and expenses: |
||||||||||||||||||||
Cost of goods sold |
17,310 | 15,771 | 16,004 | 13,158 | 5,476 | |||||||||||||||
Marketing, general and administrative |
14,392 | 13,806 | 13,995 | 12,556 | 5,206 | |||||||||||||||
Research and development |
4,058 | 3,461 | 2,828 | 1,893 | 776 | |||||||||||||||
Total costs and expenses |
35,760 | 33,038 | 32,827 | 27,607 | 11,458 | |||||||||||||||
(Loss) income from operations |
(5,550 | ) | 5,800 | (3,036 | ) | (683 | ) | 3,263 | ||||||||||||
Other (expense) and income: |
||||||||||||||||||||
Gain on sale
of available for sale securities |
0 | 75 | 1,157 | 3,412 | 0 | |||||||||||||||
Equity in Ocular Telehealth Management, LLC |
(88 | ) | (88 | ) | (174 | ) | (64 | ) | 0 | |||||||||||
Goodwill Impairment |
(9,575 | ) | 0 | 0 | 0 | 0 | ||||||||||||||
Interest income |
300 | 208 | 162 | 69 | 59 | |||||||||||||||
Interest expense |
(12 | ) | (29 | ) | (64 | ) | (55 | ) | (407 | ) | ||||||||||
Total other (expense) and income |
(9,375 | ) | 166 | 1,081 | 3,362 | (348 | ) | |||||||||||||
Net (loss) income before taxes |
(14,925 | ) | 5,966 | (1,955 | ) | 2,679 | 2,915 | |||||||||||||
Provision for income taxes |
135 | 51 | 31 | 232 | 173 | |||||||||||||||
Net (loss) income |
$ | (15,060 | ) | $ | 5,915 | $ | (1,986 | ) | $ | 2,447 | $ | 2,742 | ||||||||
Basic net (loss) income per share |
$ | (2.36 | ) | $ | 0.93 | $ | (0.32 | ) | $ | 0.42 | $ | 0.70 | ||||||||
Diluted net (loss) income per share |
$ | (2.36 | ) | $ | 0.92 | $ | (0.32 | ) | $ | 0.39 | $ | 0.64 | ||||||||
Weighted average shares basic used
in per share calculation |
6,389 | 6,375 | 6,152 | 5,832 | 3,897 | |||||||||||||||
Weighted average shares diluted
used in per share calculation |
6,389 | 6,434 | 6,152 | 6,231 | 4,304 | |||||||||||||||
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At June 30, | ||||||||||||||||||||
2008 | 2007 | 2006 | 2005 | 2004 | ||||||||||||||||
(Amounts in thousands) | ||||||||||||||||||||
Balance Sheet Data: |
||||||||||||||||||||
Cash and cash equivalents |
$ | 3,708 | $ | 8,879 | $ | 3,380 | $ | 5,116 | $ | 12,602 | ||||||||||
Working capital |
10,547 | 17,238 | 10,616 | 13,613 | 13,966 | |||||||||||||||
Total assets |
31,896 | 45,017 | 38,645 | 40,049 | 29,457 | |||||||||||||||
Short Term Debt |
501,752 | 150,200 | 232,837 | 2,396 | 0 | |||||||||||||||
Long-term debt, net of current portion |
250,871 | 0 | 163 | 392 | 2,396 | |||||||||||||||
Total liabilities |
7,364 | 5,612 | 5,545 | 5,530 | 5,996 | |||||||||||||||
Accumulated deficit |
(43,267 | ) | (28,208 | ) | (34,122 | ) | (32,136 | ) | (34,585 | ) |
No cash dividends were paid in any of the periods presented.
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 Part IA of this Form 10-K.
The Company operates primarily in five reportable business segments: Drew, Sonomed, Vascular,
Medical/Trek and 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 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 its May 29, 2008 purchase of JAS (see footnote 11).
Sonomed develops, manufactures and markets ultrasound systems used for diagnosis or biometric
applications in ophthalmology.
Vascular develops, manufactures and markets vascular access products.
Medical/Trek develops, manufactures and distributes ophthalmic surgical products under the
Escalon Medical Corp. and/or 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, 2008 and 2007
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 increased approximately 7.5% during fiscal year ended June 30, 2008 as compared to the prior fiscal year. The increase is primarily related to strong sales in the Companys Drew, Vascular, and EMI business units which increased approximately 14.7%, 18.8%, and 18.7%, respectively, offset by sales decreases in the Sonomed and Trek business units of 4.6% and 5.5%, respectively. |
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| Other revenue decreased approximately $10,723,000 or 98.0% during the fiscal year ended June 30, 2008 as compared to the prior fiscal year. The decrease is due primarily to the $9,600,000 settlement payment received from Intralase on February 27, 2007. | ||
| Cost of goods sold as a percentage of product revenue increased to approximately 57.7% of revenues during the fiscal year ended June 30, 2008, as compared to approximately 56.5% of product revenue for the prior fiscal year. Gross margins in the Drew business unit have historically been lower than those in the Companys other business units. Cost of goods sold in the Drew business unit was approximately 67.0% of product revenue during the fiscal year ended June 30, 2008 as compared to approximately 66.1% in the prior fiscal year. The aggregate cost of goods sold as a percentage of product revenue of the Sonomed, Vascular, EMI and Medical/Trek business units during fiscal year ended June 30, 2008 increased to approximately 52.0% of product revenue from approximately 51.6% in the prior fiscal year. | ||
| Operating expenses increased approximately 6.9% during the fiscal year ended June 30, 2008 as compared to the prior fiscal year. This was due to increased consulting expenses related to the implementation of an ERP System during the current period and increased research and development at the Drew, Sonomed and Vascular divisions. | ||
| The Company concluded that $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 (see footnote 3 for additional information). |
Results of Operations
Fiscal Years Ended June 30, 2008 and 2007
The following table shows consolidated product revenue by business unit as well as identifying
trends in business unit product revenues for the fiscal years ended June 30, 2008 and 2007. Table
amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||
2008 | 2007 | % Change | ||||||||||
Product Revenue: |
||||||||||||
Drew |
$ | 13,332 | $ | 11,627 | 14.7 | % | ||||||
Sonomed |
9,367 | 9,823 | -4.6 | % | ||||||||
Vascular |
4,119 | 3,467 | 18.8 | % | ||||||||
EMI |
1,762 | 1,484 | 18.7 | % | ||||||||
Medical/Trek |
1,410 | 1,492 | -5.5 | % | ||||||||
Total |
$ | 29,990 | $ | 27,893 | 7.5 | % | ||||||
Consolidated product revenue increased approximately $2,097,000, or 7.5%, to $29,990,000
during the year ended June 30, 2008 as compared to the last fiscal year.
In the Drew business unit, product revenue increased $1,705,000, or 14.7%, as compared to last
fiscal year. The increase is primarily due to the sales of Drews D3 instrument which received FDA
market clearance on December 18, 2007, strong demand for the Primus instrument and continued growth of
Drews reagent sales from its United Kingdom facility.
Drew anticipates launching its new DS-360
Analyzer for in the second half of fiscal 2009.
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Product revenue decreased $456,000, or 4.6%, to $9,367,000 in the Sonomed business unit as
compared to the last fiscal year. The decrease in product revenue was caused by the continued
migration of Sonomeds revenue to international markets. The international market is served
primarily by distributors who receive significant discounts as compared to traditional direct sales
in the Domestic market.
Product revenue increased $652,000, or 18.8%, to $4,119,000, at the Vascular business unit
during the year ended June 30, 2008 as compared to last fiscal year. The increase was primarily
caused by the introduction of the new VascuView instrument which generated $550,000 in revenue
during the year.
Overall needle volume was slightly lower during the year, however, a midyear price adjustment resulted
in higher needle revenue for the year.
Product revenue increased $278,000, or 18.7%, in the EMI business unit when compared to the
last fiscal year. This increase is attributable to the increase in sales of the digital imaging
systems from the January 2006 MRP acquisition. The EMI product offering continues to expand and
has seen significant market acceptance during the year ended June 30, 2008.
In the Medical/Trek business unit, product revenue decreased $82,000, or 5.5%, to $1,410,000
during the year ended June 30, 2008 as compared to the last fiscal year.
The following table presents consolidated other revenue by reportable business unit for the
fiscal years ended June 30, 2008 and 2007. Table amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||
2008 | 2007 | % Change | ||||||||||
Other Revenue: |
||||||||||||
Drew |
$ | 222 | $ | 243 | -8.6 | % | ||||||
Sonomed |
0 | 0 | 0.0 | % | ||||||||
Vascular |
0 | 0 | 0.0 | % | ||||||||
EMI |
0 | 0 | 0.0 | % | ||||||||
Medical/Trek |
0 | 10,702 | -100.0 | % | ||||||||
Total |
$ | 222 | $ | 10,945 | -98.0 | % | ||||||
Consolidated other revenue decreased by approximately $10,723,000, or 98.0%, to $222,000
during the fiscal year ended June 30, 2008 as compared to the prior fiscal year. The decrease is
primarily due to the $9,600,000 settlement reached with Intralase on February 27, 2007. Under the
settlement agreement, Intralase made a lump sum payment to Escalon of $9,600,000 in exchange for
which all pending litigation between the parties was dismissed, the parties exchanged general
releases, the Company transferred to Intralase its ownership of patents and intellectual property
formerly licensed to Intralase by the Company, and the License Agreement was terminated. In
addition, the payment from Intralase satisfied all outstanding past, current and future royalties
owed or alleged to be owed by Intralase to the Company.
The following table presents consolidated cost of goods sold by reportable business unit and
as a percentage of related unit product revenues for the fiscal years ended June 30, 2008 and 2007.
Table amounts are in thousands:
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Fiscal Years Ended June 30, | ||||||||||||||||
2008 | % | 2007 | % | |||||||||||||
Cost of Goods Sold: |
||||||||||||||||
Drew |
$ | 8,928 | 67.0 | % | $ | 7,681 | 66.1 | % | ||||||||
Sonomed |
5,029 | 53.7 | % | 4,976 | 50.7 | % | ||||||||||
Vascular |
1,538 | 37.3 | % | 1,393 | 40.2 | % | ||||||||||
EMI |
820 | 46.5 | % | 711 | 47.9 | % | ||||||||||
Medical/Trek |
995 | 70.6 | % | 1,011 | 67.8 | % | ||||||||||
Total |
$ | 17,310 | 57.7 | % | $ | 15,772 | 56.5 | % | ||||||||
Consolidated cost of goods sold totaled approximately $17,310,000, or 57.7%, of product
revenue, for the fiscal year ended June 30, 2008 as compared to $15,772,000, or 56.5%, of product
revenue, for the prior fiscal year.
Cost of goods sold in the Drew business unit totaled $8,928,000, or 67.0%, of product revenue,
for the fiscal year ended June 30, 2008 as compared to $7,681,000, or 66.1%, of product revenue,
for the prior fiscal year. The increase in the cost of goods sold as a percentage of revenue is
due to the margin compression related to the continued strength of the Euro against the US Dollar
which negatively affects the margins on Drews new D3 offering that is manufactured in France by an
OEM partner. The decrease in instrument gross margins was partially offset by an increase in the
sale of higher volume spare parts and continued sales of higher gross margin reagents. This margin
compression is expected to continue in the near term until there is a favorable foreign exchange
change and until the introduction of Drews higher margin instruments, the HT and DS360, currently
under development and expected to become available for sale during fiscal 2009.
Cost of goods sold in the Sonomed business unit totaled $5,029,000, or 53.7%, of product
revenue, for the fiscal year ended June 30, 2008 as compared to $4,976,000, or 50.7%, of product
revenue, for prior fiscal year. 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 of the Companys new Vumax II ultrasound systems.
Cost of goods sold in the Vascular business unit totaled $1,538,000, or 37.3%, of product
revenue, for fiscal year ended June 30, 2008 as compared to $1,393,000, or 40.2%, of product
revenue, for the last fiscal year. The decrease as a percentage of product revenue was due to a
price increase during the year on traditional needle business offset by the $585,000 of revenue
during the year on Vasculars new lower margin VascuView product.
Cost of goods sold in the EMI business unit totaled $820,000, or 46.5%, of product revenue,
for fiscal year ended June 30, 2008 as compared to $711,000, or 47.9%, of product revenue, for the
last fiscal year. The decrease as a percentage of product revenue was due to continued production
efficiencies and lower sales discounts in the second half of 2008.
Cost of goods sold in the Medical/Trek business unit totaled $995,000, or 70.6%, of product
revenue, for the fiscal year ended June 30, 2008 as compared to $1,011,000, or 67.8%, of product
revenue, for the last fiscal year. The increase as a percentage of product revenue was due to
increased material costs which Trek was unable to completely pass on to its customers.
The following table presents consolidated marketing, general and administrative expenses as
well as identifying trends in business unit marketing, general and administrative expenses for the
fiscal years ended June 30, 2008 and 2007. Table amounts are in thousands:
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Fiscal Years Ended June 30, | ||||||||||||
2008 | 2007 | % Change | ||||||||||
Marketing, General and Administrative: | ||||||||||||
Drew |
$ | 5,287 | $ | 5,475 | -3.4 | % | ||||||
Sonomed |
2,219 | 1,931 | 14.9 | % | ||||||||
Vascular |
1,576 | 1,598 | -1.4 | % | ||||||||
EMI |
605 | 480 | 26.0 | % | ||||||||
Medical/Trek |
4,705 | 4,323 | 8.8 | % | ||||||||
Total |
$ | 14,392 | $ | 13,807 | 4.2 | % | ||||||
Consolidated marketing, general and administrative expenses increased $585,000, or 4.2%, to
$14,392,000 during the fiscal year ended June 30, 2008 as compared to the prior fiscal year.
Marketing, general and administrative expenses in the Drew business unit decreased $188,000,
or 3.4%, to $5,287,000 as compared to the same period last fiscal year. The decrease is primarily
due to a reduction in headcount during the year offset by increased legal fees of approximately
$580,000 related to breach of contract litigation between Drew and PointCare Technologies. Drew
implemented significant reductions in force during June 2008, the full effect of this cost
reduction plan of approximately $1.5 million, is expected to be realized during fiscal 2009.
Marketing, general and administrative expenses in the Sonomed business unit increased by
$288,000, or 14.9%, to $2,219,000 as compared to the prior fiscal year. The increase is due
primarily to the increase in international marketing consulting in Europe and the addition of a
consultant in Southeast Asia, increased travel and advertising related to marketing and trade show
activity during the current year.
Marketing, general and administrative expenses in the Vascular business unit decreased
$22,000, or 1.4%, to $1,576,000 as compared to the same period last fiscal year.
Marketing, general and administrative expenses in the EMI business unit increased $125,000 or
26.0% to $605,000 as compared to last fiscal year. The increase is primarily related to the
addition of sales people during the year.
The Medical/Trek business units marketing, general and administrative expenses increased
$382,000 or 8.8% to $4,705,000 as compared to the last fiscal year. The increase was due primarily
to the addition of a chief operating officer and controller during the year, compensation expense
for directors under SFAS No. 123(R) rules, and increased third party consultants in valuation
services, information technology and the implementation of a new
company-wide ERP system during the
year.
The following table presents consolidated research and development expenses by reportable
business unit and as a percentage of related unit product revenues for the fiscal years ended June
30, 2008 and 2007. Table amounts are in thousands:
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Fiscal Years Ended June 30, | ||||||||||||
2008 | 2007 | % Change | ||||||||||
Research and Development: |
||||||||||||
Drew |
$ | 2,745 | $ | 2,355 | 16.6 | % | ||||||
Sonomed |
779 | 495 | 57.4 | % | ||||||||
Vascular |
260 | 172 | 51.2 | % | ||||||||
EMI |
268 | 350 | -23.4 | % | ||||||||
Medical/Trek |
6 | 89 | -93.3 | % | ||||||||
Total |
$ | 4,058 | $ | 3,461 | 17.3 | % | ||||||
Consolidated research and development expenses increased $597,000, or 17.3%, to $4,058,000
during the fiscal year ended June 30, 2008 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 Vascular business units.
Research and development expenses in the Drew business unit increased $390,000, or 16.6%, to
$2,745,000. The increase was primarily related to additional salaries and benefits and consulting
fees associated with the development of the DS-360, a diabetes instrument, the HT, a CD4 instrument
and the development of additional chemical reagents for use on Drews Trilogy instrument.
Research and development expenses in the Sonomed business unit increased $284,000 to $779,000
as compared to the last fiscal year. The increase is primarily due to consulting expenses incurred
during the fourth quarter related to the development of Sonomeds next generation ultrasound
instrument, the VuMax III and continued improvements made to Sonomeds existing product offering.
Sonomed expects to submit the VuMax III instrument for FDA market
clearance during the second half of
fiscal 2009.
Research and development expenses in the Vascular business unit increased $88,000 to $260,000
as compared to the last fiscal year. The increase was primarily due to completing the development
of the VascuViewTM, a new visual ultrasound device, which received FDA market
clearance on January 20,
2008.
Research and development in the EMI business unit decreased $82,000 to $268,000 as compared to
the last fiscal year. The decrease was primarily due to higher expenses in the prior period
related to various enhancements to EMIs digital systems.
Research and development in the Medical/Trek business unit decreased $83,000 to $6,000 as
compared to the last fiscal year. This decrease is due primarily to the elimination of the
corporate research and development department in the first quarter of fiscal 2007 related to the
Companys previously announced cost reduction plan.
Goodwill Impairment
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 unit 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 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
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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 unit, including profit margins, long-term
forecasts, discount rates and terminal growth rates, reflect the Companys best estimates.
Other Income and Expenses
Gain on sale of available for sale securities was approximately $0 and $75,000 during the
fiscal years ended June 30, 2008 and 2007, respectively due to the sale of 0 shares and 3,000
shares of Intralase common stock during fiscal 2008 and 2007, respectively. The Company has no
remaining available for sale securities.
The Company recognized a loss of approximately $88,000 and $88,000 related to its investment
in Ocular Telehealth Management (OTM) during the fiscal years ended June 30, 2008 and 2007,
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 13 of the notes to consolidated financial statements.)
Interest income was $300,000 and $208,000 for the fiscal years ended June 30, 2008 and 2007,
respectively. The increase was due to higher cash balances and effective yields on investments.
Interest expense was $12,000 and $29,000 for the fiscal years ended June 30, 2008 and 2007,
respectively.
Results of Operations
Fiscal Years Ended June 30, 2007 and 2006
The following table shows consolidated product revenue by business unit as well as identifying
trends in business unit product revenues for the fiscal years ended June 30, 2007 and 2006. Table
amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||
2007 | 2006 | % Change | ||||||||||
Product Revenue: |
||||||||||||
Drew |
$ | 11,627 | $ | 14,253 | -18.4 | % | ||||||
Sonomed |
9,823 | 7,737 | 27.0 | % | ||||||||
Vascular |
3,467 | 3,640 | -4.8 | % | ||||||||
EMI |
1,484 | 434 | 241.9 | % | ||||||||
Medical/Trek |
1,492 | 1,480 | 0.8 | % | ||||||||
Total |
$ | 27,893 | $ | 27,544 | 1.3 | % | ||||||
Consolidated product revenue increased approximately $349,000, or 1.3%, to $27,893,000 during
the year ended June 30, 2007 as compared to the fiscal year ended June 30, 2006.
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In the Drew business unit, product revenue decreased $2,626,000, or 18.4% as compared to as
compared to the fiscal year ended June 30, 2006. The decrease is primarily due to the non-renewal
of two OEM agreements and the continued delay in the introduction of Drews new line of products in
fiscal 2007. In July 2007, Drew received 510(k) clearance from the FDA to market the new TRILOGY
Analyzer. TRILOGY, a multifunction analyzer used in determination of analytes in body fluids, is an
open system intended for clinical use in a professional setting for use with various chemistry
assays. Drew anticipates receiving approval on its new D3 Analyzer in the second quarter of fiscal
2008 which will provide two upgraded instruments for sale in fiscal 2008. Additionally, Drew
anticipates submitting its new DS-360 Analyzer for FDA approval in the second half of fiscal 2008.
Product revenue increased $2,086,000, or 27.0%, to $9,823,000 in the Sonomed business unit as
compared to the fiscal year ended June 30, 2006. The increase in product revenue was primarily
caused by an increase in sales of the Companys EZ AB scan ultrasound systems as well as increased
sales of the new VuMax high frequency systems and an overall increase in export sales.
Product revenue decreased $173,000, or 4.8%, to $3,467,000, at the Vascular business unit
during the year ended June 30, 2007 as compared to the fiscal year ended June 30, 2006. The
decrease was primarily caused by a decrease in revenues from Companys distributor network due to
the termination of its relationship with several distributors during 2006 and 2005. This decrease
was partially offset by an increase in direct sales to end users by the Companys domestic sales
team. The Company continues to replace the territories of the terminated distributors with direct
sales efforts.
Product revenue increased $1,050,000, or 241.9%, in the EMI business unit when compared to the
fiscal year June 30, 2006. This increase is attributable to the increase in sales of the digital
imaging systems from the January 2006 MRP acquisition. The EMI product offering continues to
expand and has seen significant market acceptance during the year ended June 30, 2007.
In the Medical/Trek business unit, product revenue increased $12,000, or 0.8%, to $1,492,000
during the year ended June 30, 2007 as compared to the fiscal year June 30, 2006.
The following table presents consolidated other revenue by reportable business unit for the
fiscal years ended June 30, 2007 and 2006. Table amounts are in thousands:
Fiscal Years Ended June 30, | |||||||||||||
2007 | 2006 | % Change | |||||||||||
Other Revenue: |
|||||||||||||
Drew |
$ | 243 | $ | 283 | (14.1 | )% | |||||||
Sonomed |
0 | 0 | 0.0 | % | |||||||||
Vascular |
0 | 0 | 0.0 | % | |||||||||
EMI |
0 | 0 | 0.0 | % | |||||||||
Medical/Trek |
10,702 | 1,964 | 444.9 | % | |||||||||
Total |
$ | 10,945 | $ | 2,247 | 387.1 | % | |||||||
Consolidated other revenue increased by approximately $8,698,000, or 387.1%, to $10,945,000
during the fiscal year ended June 30, 2007 as compared to the fiscal year June 30, 2006. The
increase is primarily due to the $9,600,000 settlement reached with Intralase on February 27, 2007.
Under the settlement agreement, Intralase made a lump sum payment to Escalon of $9,600,000 in
exchange for which all pending litigation between the parties was dismissed, the parties exchanged
general releases, the Company transferred to Intralase its ownership of patents and intellectual
property formerly licensed to Intralase by the Company, and the License Agreement was terminated.
In addition, the payment from Intralase satisfied all outstanding past, current and future
royalties owed or alleged to be owed by Intralase to the Company.
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Other revenue from the prior year of $3,060,000 and the amount in the current year in excess
of the $9,600,000 Intralase settlement of $1,102,000 is related to royalties received from
Intralase license agreement received prior to the settlement and royalties received by Drew related
to the Bio-Rad license agreement.
The following table presents consolidated cost of goods sold by reportable business unit and
as a percentage of related unit product revenues for the fiscal years ended June 30, 2007 and 2006.
Table amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||||||
2007 | % | 2006 | % | |||||||||||||
Cost of Goods Sold: |
||||||||||||||||
Drew |
$ | 7,681 | 66.1 | % | $ | 9,225 | 64.7 | % | ||||||||
Sonomed |
4,976 | 50.7 | % | 3,962 | 51.2 | % | ||||||||||
Vascular |
1,393 | 40.2 | % | 1,535 | 42.2 | % | ||||||||||
EMI |
711 | 47.9 | % | 290 | 66.8 | % | ||||||||||
Medical/Trek |
1,011 | 67.8 | % | 992 | 67.0 | % | ||||||||||
Total |
$ | 15,772 | 56.5 | % | $ | 16,004 | 58.1 | % | ||||||||
Consolidated cost of goods sold totaled approximately $15,772,000, or 56.5% of product
revenue, for the fiscal year ended June 30, 2007 as compared to $16,004,000 or 58.1 of product
revenue for the fiscal year ended June 30, 2006.
Cost of goods sold in the Drew business unit totaled $7,681,000, or 66.1% of product revenue,
for the fiscal year ended June 30, 2007 as compared to $9,225,000, or 64.7% of product revenue, for
the fiscal year ended June 30, 2006. The increase in the cost of goods sold as a percentage of
revenue is due to the margin compression related to the continued aging of Drews existing product
offering. The decrease in instrument gross margins was partially offset by an increase in the sale
of higher volume spare parts and continued sales of higher gross margin reagents.
Cost of goods sold in the Sonomed business unit totaled $4,976,000, or 50.7% of product
revenue, for the fiscal year ended June 30, 2007 as compared to $3,962,000, or 51.2% of product
revenue, for fiscal year ended June 30, 2006. The primary reason for the decrease as a percentage
of product revenue was an increase in the percentage of domestic sales during the period. The
Company historically experiences a higher selling price per unit on its domestic product sales.
Cost of goods sold in the Vascular business unit totaled $1,393,000, or 40.2% of product
revenue, for fiscal year ended June 30, 2007 as compared to $1,535,000, or 42.2% of product
revenue, for the fiscal year ended June 30, 2006. The decrease as a percentage of product revenue
was due to lower overtime and higher production efficiencies in the current period as compared to
the prior year.
Cost of goods sold in the EMI business unit totaled $711,000, or 47.9% of product revenue, for
fiscal year ended June 30, 2007 as compared to $290,000, or 66.8% of product revenue, for the
fiscal year ended June 30, 2006. The significant improvement in gross margins is related to
improved production techniques implemented during the year and EMIs ability to drive down the cost
of components due to increased purchases made during the year to keep pace with its significant
sales growth.
Cost of goods sold in the Medical/Trek business unit totaled $1,011,000, or 67.8% of product
revenue, for the fiscal year ended June 30, 2007 as compared to $992,000, or 67.0% of product
revenue, for the fiscal year ended June 30, 2006.
27
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The following table presents consolidated marketing, general and administrative expenses as
well as identifying trends in business unit marketing, general and administrative expenses for the
fiscal years ended June 30, 2007 and 2006. Table amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||
2007 | 2006 | % Change | ||||||||||
Marketing, General and Administrative: | ||||||||||||
Drew |
$ | 5,475 | $ | 6,006 | -8.9 | % | ||||||
Sonomed |
1,931 | 2,098 | -8.0 | % | ||||||||
Vascular |
1,598 | 1,682 | -5.0 | % | ||||||||
EMI |
480 | 550 | -12.7 | % | ||||||||
Medical/Trek |
4,323 | 3,659 | 18.2 | % | ||||||||
Total |
$ | 13,807 | $ | 13,995 | -1.4 | % | ||||||
Consolidated marketing, general and administrative expenses decreased $188,000, or 1.4%, to
$13,807,000 during the fiscal year ended June 30, 2007 as compared to the fiscal year ended June
30, 2006.
Marketing, general and administrative expenses in the Drew business unit decreased $531,000,
or 8.9%, to $5,475,000 as compared to the fiscal year ended June 30, 2006. The decrease is
primarily due to the realization of previously announced cost reductions initiated during the first
quarter of the 2007 fiscal year, offset by related charges incurred in consolidating our foot print
in the United Kingdom down to one site from three in the previous year, and from increased legal
and severance costs. The full effect of our previously announced cost reduction plan is expected
to be realized during fiscal 2008.
Marketing, general and administrative expenses in the Sonomed business unit decreased by
$167,000, or 8.0%, to $1,931,000 as compared to the fiscal year ended June 30, 2006. The decrease
is due primarily to the decreased need, as compared to the prior fiscal year, for travel and
advertising expenses related to the introduction and expansion into international markets related
to the roll out of Sonomeds new UBM Instrument.
Marketing, general and administrative expenses in the Vascular business unit decreased
$84,000, or 5.0%, to $1,598,000 as compared to the fiscal year ended June 30, 2006. The decrease
was due mainly to the discontinuance of the relationship with an under performing European sales
consultant and a more efficient approach to domestic sales travel and other marketing related
expenses, including printed material and attendance at trade shows.
Marketing, general and administrative expenses in the EMI business unit decreased $70,000 or
12.7%, to $480,000 as compared the fiscal year ended June 30, 2006. The decrease is primarily
related to additional costs incurred in the prior year on printed and other advertising materials.
The Medical/Trek business units marketing, general and administrative expenses increased
$664,000, or 18.2%, to $4,323,000 as compared to the fiscal year ended June 30, 2006. The increase
was due primarily to $163,000 incurred during this fiscal year under the new SFAS No. 123(R) rules,
increased discretionary bonuses of $175,000, increased corporate salaries of approximately $194,000
and increased third party consultants in accounting, valuation services, and information technology
of $68,000 and increased insurance costs of $64,000.
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The following table presents consolidated research and development expenses by reportable
business unit and as a percentage of related unit product revenues for the fiscal years ended June
30, 2007 and 2006. Table amounts are in thousands:
Fiscal Years Ended June 30, | ||||||||||||
2007 | 2006 | % Change | ||||||||||
Research and Development: | ||||||||||||
Drew |
$ | 2,355 | $ | 1,734 | 35.8 | % | ||||||
Sonomed |
495 | 511 | -3.1 | % | ||||||||
Vascular |
172 | 164 | 4.9 | % | ||||||||
EMI |
350 | 85 | 311.8 | % | ||||||||
Medical/Trek |
89 | 334 | -73.4 | % | ||||||||
Total |
$ | 3,461 | $ | 2,828 | 22.4 | % | ||||||
Consolidated research and development expenses increased $633,000, or 22.4%, to $3,461,000
during the fiscal year ended June 30, 2007 as compared to the fiscal year ended June 30, 2006.
Research and development expenses were primarily expenses associated with the planned introduction
of new or enhanced products in the Drew and EMI business units.
Research and development expenses in the Drew business unit increased $621,000, or 35.8%, to
$2,355,000. The increase is primarily due to increased employee headcount, consulting and other
related product development expenses for Drews continued research on two new instruments, the Drew
DS-360 and the XL2280.
Research and development expenses in the Sonomed business unit decreased $16,000 to $495,000
as compared to the fiscal year ended June 30, 2006. The decrease is primarily due to a completion
of Sonomeds new UBM instrument in the prior year offset by continued enhancements to Sonomeds
existing products.
Research and development in the Vascular business unit increased $8,000 to $172,000 as
compared to the fiscal year ended June 30, 2006.
Research and development in the EMI business unit increased $265,000 to $350,000 as compared
to the fiscal year ended June 30, 2006. The increase is due to additional employees related to
continued development and enhancement of the Companys digital ophthalmic product offerings.
Research and development in the Medical/Trek business unit decreased $245,000 to $89,000 as
compared to the fiscal year ended June 30, 2006. This decrease is due primarily to the elimination
of the corporate research and development department in the first quarter of fiscal 2007 related to
the Companys previously announced cost reduction plan.
Gain on sale of available for sale securities was approximately $75,000 and $1,157,000 during
the fiscal years ended June 30, 2007 and 2006, respectively due to the sale of 3,000 shares and
58,585 shares of Intralase common stock during fiscal 2007 and 2006, respectively. The Company has
no remaining available for sale securities.
The Company recognized a loss of approximately $88,000 and $174,000 related to its investment
in Ocular Telehealth Management (OTM) during the fiscal years ended June 30, 2007 and 2006,
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 13 of the notes to consolidated financial statements.)
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Interest income was $208,000 and $162,000 for the fiscal years ended June 30, 2007 and 2006,
respectively. The increase was due to higher cash balances and effective yields on investments.
Interest expense was $29,000 and $64,000 for the fiscal years ended June 30, 2007 and 2006,
respectively.
Liquidity and Capital Resources
The following table presents overall liquidity and capital resources from continuing
operations during the fiscal years ended June 30, 2008 and 2007. Table amounts are in thousands:
June 30, | ||||||||
2008 | 2007 | |||||||
Current Ratio: |
||||||||
Current assets |
$ | 16,573 | $ | 21,763 | ||||
Less: Current liabilities |
6,026 | 4,525 | ||||||
Working capital |
$ | 10,547 | $ | 17,238 | ||||
Current ratio |
2.8 to 1 | 4.8 to 1 | ||||||
Debt to Total Capital Ratio: |
||||||||
Notes payable and current maturities |
$ | 502 | $ | 150 | ||||
Long-term debt |
$ | 251 | 0 | |||||
Total debt |
$ | 753 | $ | 150 | ||||
Total equity |
24,532 | 39,406 | ||||||
Total capital |
$ | 25,285 | $ | 39,556 | ||||
Total debt to total capital |
3.0 | % | 0.4 | % | ||||
Working Capital Position
Working capital decreased $6,691,000 as of June 30, 2008 and the current ratio decreased to
2.8 to 1 from 4.8 to 1 when compared to June 30, 2007. The decrease in working capital was caused
primarily by a decrease in cash of $5,171,000 from $8,879,000 to $3,708,000 in 2007 and 2008,
respectively. Accounts receivable decreased $757,000 from $4,653,000 in 2007 to $3,896,000 in
2008. Overall total current assets decreased $5,190,000 from $21,763,000 in 2007 to $16,573,000 in
2008. Total current liabilities which consist of current portion of long term debt, accounts
payable and accrued expenses increased $1,501,000, from $4,525,000 in 2007 to $6,026,000 in 2008.
Our principal source of short term liquidity is existing cash and
cash equivalents which we believe will be sufficient to meet our operating needs and
anticipated capital expenditures over at least the next twelve months.
For the long term, we intend to utilize principally existing cash and cash equivalents as
well as internally generated funds, which are anticipated to be derived primarily from
the sale of existing products and reagents and instrumentation products and
reagents currently under development. To the extent that these sources of liquidity are
insufficient, we may consider issuing debt or equity securities or
curtailing or reducing our operations.
Cash Used In or Provided By Operating Activities
During fiscal 2008, the Company used approximately $2,936,000 of cash for operating activities
as compared to generating approximately $5,783,000 from operating activities during the year ended
June 30, 2007. The net decrease in cash generated from operating activities of approximately
$8,719,000 in fiscal 2008 as compared to fiscal 2007 is due primarily to the following factors:
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Loss from operations increased approximately $20,974,000 in fiscal 2008 as compared to fiscal
2007, from $5,915,000 in 2007 to $(15,060,000) in 2008, the net loss for 2008 includes a non-cash
goodwill impairment charge in the amount of $9,575,000. The net income in 2007 was driven by net
income in the other Escalon companies of approximately $9,585,000 offset by a net loss at our Drew
division of approximately $3,670,000. The income in the legacy Escalon companies includes the
$9,600,000 settlement payment received from Intralase.
Cash Flows Used In Investing and Financing Activities
Cash flows used in investing activities for 2008 were approximately $2,007,000. This amount
is made up of purchases of fixed assets of $613,000, investment in OTM of $69,000, and the purchase
of JAS Diagnostics, Inc. in the amount of $1,325,000.
Cash flows used in investing activities for 2007 were approximately $216,000. This amount is
made up of the net proceeds of $75,000 realized on the sale of the remaining Intralase securities
held by the Company as available for sale securities, purchases of fixed assets of $260,000 and
investment in OTM of $31,000.
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 $143,000 during 2008 relate to
repayment of debt of $150,000 and offset by the proceeds from the issuance of common stock options
and issuance of $7,000.
Cash flows used in financing activities in the amount of $62,000 during 2007 relate to
repayment of debt of $245,000, offset by the proceeds $183,000 from the issuance of common stock
options.
Debt History
Drew had long-term debt facilities through the Texas Mezzanine Fund and through Symbiotics,
Inc. The Texas Mezzanine Fund debt provided for interest at fixed rate of 8% per annum until July
1, 2005. The interest rate was then adjusted to the prime rate plus 4% per annum. Each June 1,
the rate was adjusted to the prime rate plus 4% per annum. The debt had a minimum interest rate of
8% per annum to a maximum interest rate of 18% per annum. The note was paid off in April 2008 and
had been secured by certain assets of Drew. The outstanding balance on the Symbiotics as of June
30, 2008 and 2007 was approximately, $0 and $16,666, respectively.
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 is payable in
six quarterly installments of $124,437 plus interest at the prime rate (5% on June 30, 2008) as
published by the Bank of America.
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, 2008 and 2007. The following table presents the Companys contractual
obligations as of June 30, 2008 (interest is not included in the table as it is not material):
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Less than | 3-5 | More than | ||||||||||||||||||
Total | 1 Year | 1-3 Years | Years | 5 Years | ||||||||||||||||
Long-term debt |
$ | 752,623 | $ | 501,752 | $ | 250,871 | $ | 0 | $ | 0 | ||||||||||
Operating lease agreements |
3,445,258 | 704,501 | 1,314,637 | 1,122,846 | 303,274 | |||||||||||||||
Total |
$ | 4,197,881 | $ | 1,206,253 | $ | 1,565,508 | $ | 1,122,846 | $ | 303,274 | ||||||||||
Forward-Looking Statement About Significant Items Likely To Impact Liquidity
On July 23, 2004, the Company acquired approximately 67% of the outstanding ordinary shares of
Drew, pursuant to the Companys exchange offer for all of the outstanding ordinary shares of Drew
and subsequently acquired the remaining shares during the fiscal year ended June 30, 2005. As of
June 30, 2006, the Company has acquired all of the outstanding ordinary shares of Drew. Drew does
not have a history of producing positive operating cash flows and, as a result, at the time of
acquisition, was operating under financial constraints and was under-capitalized. As Drew is
integrated into the Company, management continues to work to reverse the situation, while at the
same time seeking to strengthen Drews market position. The Company has loaned approximately $20
million to Drew. The funds have been primarily used to procure components to build up inventory to
support the manufacturing process as well as to pay off accounts payable and debt of Drew. The
Company may need to provide further working capital for Drew.
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, 2008, Escalon complied with these 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
Statement of Accounting Standards (SFAS) No. 142 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 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 and
purchased intangible assets. Actual results
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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 3 to
consolidated financial statements included in this Form 10-K for details on a goodwill impairment
charge related to the carrying amount of 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. See footnote 3 to the consolidated financial statements.
Income/(Loss) Per Share
The Company computes net income/(loss) per share under the provisions of SFAS No. 128,
Earnings Per Share, (SFAS 128) and Staff Accounting Bulletin, No. 98 (SAB 98).
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Under the provisions of SFAS 128 and SAB 98, 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. SFAS 109 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, 2008, the Company has recorded a full valuation allowance against the
Companys net operating losses 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.
Stock-Based Compensation
Effective July 1, 2007, the Company adopted the fair value recognition provisions of Statement
of Financial Accounting Standards 123(R) (SFAS 123(R)) 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 2006 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
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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 25.
Recently Issued Accounting Standards
In December 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 141(R),
Business Combinations (SFAS 141(R)). SFAS 141(R) will significantly change the accounting
for business combinations in a number of areas including the treatment of contingent
consideration, contingencies, acquisition costs, in-process research and development and
restructuring costs. In addition, under SFAS 141(R), changes in deferred tax asset valuation
allowances and acquired income tax uncertainties in a business combination after the measurement
period will impact income tax expense. SFAS 141(R) applies prospectively to business combinations
for which the acquisition date is on or after the beginning of the first annual reporting period
beginning on or after December 15, 2008. Early application is not permitted. The effect of SFAS
141(R) on our consolidated financial statements will be dependent on the nature and terms of any
business combinations that we consummate on or after July 1, 2009.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements (SFAS 160). SFAS 160 amends Accounting Research Bulletin No. 51 to establish
accounting and reporting standards for the noncontrolling (minority) interest in a subsidiary and
for the deconsolidation of a subsidiary. It clarifies that a noncontrolling interest in a
subsidiary is an ownership interest in the consolidated entity that should be reported as equity in
the consolidated financial statements and establishes a single method of accounting for changes in
a parents ownership interest in a subsidiary that do not result in deconsolidation. SFAS 160 is
effective for fiscal years beginning on or after December 15, 2008. We do not expect the adoption
of SFAS 160 to have a significant impact on our consolidated financial statements unless a future
transaction results in a noncontrolling interest in a subsidiary.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities Including an Amendment of FASB Statement No. 115 (SFAS No. 159). SFAS No.
159 permits a company to choose to measure many financial instruments and other items at fair value
that are not currently required to be measured at fair value. The objective is to improve financial
reporting by providing a company with the opportunity to mitigate volatility in reported earnings
caused by measuring related assets and liabilities differently without having to apply complex
hedge accounting provisions. SFAS No. 159 is effective for fiscal years beginning after November
15, 2007 and, accordingly, we adopted the provisions of this Statement on July 1, 2008. We are
currently evaluating the impact of the adoption of SFAS No. 159 on our consolidated financial
statements. However, we do not expect the effect to be significant.
In June 2007, the FASB ratified Emerging Issues Task Force Issue 07-3, Accounting for Advance
Payments for Goods or Services to Be Used in Future Research and Development Activities (EITF
07-3). EITF 07-3 provides guidance on the capitalization of non-refundable advance payments for
goods and services to be used in future research and development activities until such goods have
been delivered or the related services have been performed. As applicable to us, this pronouncement
became effective for our fiscal year beginning on July 1, 2008. We do not expect the adoption of
this pronouncement to have a material effect on our consolidated financial statements.
In July 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxesan interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the accounting for
uncertainty in income taxes recognized in the enterprises financial statements. This
Interpretation prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to be taken in the tax
return. We adopted the provisions of FIN 48 on July 1, 2007. As of the date of adoption, the
2005-2007 tax years remain subject to examination
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by major tax jurisdictions. As of June 30, 2008,
the 2005-2007 tax years remain subject to examination by major tax jurisdictions.
As a result of the implementation of FIN 48, we recognized no material adjustments in the
liability for unrecognized income tax benefits and, at the adoption date of July 1, 2008, we had no
unrecognized tax benefits which would have affected our effective tax rate if recognized. At June
30, 2008, we also had no unrecognized tax benefits. If uncertain tax positions had been recorded,
then we would recognize interest and penalties related to uncertain tax positions in income tax
expense. As of June 30, 2008, no accrued interest related to uncertain tax positions has been
recorded.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS No. 157).
SFAS No. 157 establishes a framework for measuring fair value and expands the disclosures on fair
value measurements. SFAS No. 157 is effective for fiscal years beginning after November 15,
2007 and, accordingly, we adopted the provisions of this Statement on July 1, 2008. We are
currently evaluating the impact of the adoption of SFAS No. 157 on our consolidated financial
statements. However, we do not expect the effect to be significant.
ITEM 7A. | QUANTITATIVE AND QUALIITATIVE DISCLOSURE ABOUT MARKET RISK |
Market risk represents the risk of loss that may impact our consolidated financial position,
results of operations or cash flows. In the normal course of doing business, we are exposed to the
risks associated with foreign currency exchange rates and changes in interest rates.
Interest Rate Risk
The table below 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 5 of the notes to
consolidated financial statements for further information regarding the Companys debt
obligations.)
2008 | Total | |||||||
Notes Payable Former JAS Shareholders |
$ | 752,623 | $ | 752,623 | ||||
Interest Rate |
5.0 | % |
Currency Fluctuations
For the years ended June 30, 2008, 2007 and 2006, approximately 13.2%, 12.5% and 12.8%,
respectively, of our 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 our 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 increases of approximately $235,000 in net revenues in 2008 compared to 2007,
$279,000 in net revenues in 2007 compared to 2006 and an increase of approximately $37,000 in net
revenues in 2006 compared to 2005. During the three years ended June 30, 2008, 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.
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June 30, | June 30, | |||||||
2008 | 2007 | |||||||
Total Foreign Sales |
12,661,554 | 11,255,394 | ||||||
Total Net Revenues |
29,988,386 | 27,892,738 | ||||||
International Percentage |
42.2 | % | 40.4 | % |
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Escalon Medical Corp.
Index to Consolidated Financial Statements
Index to Consolidated Financial Statements
Page | ||||
38 | ||||
39 | ||||
40 | ||||
41 | ||||
42 | ||||
43 |
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the
Board of Directors and
Stockholders of Escalon Medical Corporation
Stockholders of Escalon Medical Corporation
We have audited the accompanying balance sheets of Escalon Medical Corporation as of June 30, 2008
and 2007, and the related statements of income, stockholders equity and comprehensive income, and
cash flows for each of the years in the three-year periods ended June 30, 2008. 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 Corporation as of June 30, 2008 and 2007, and
the results of its operations and its cash flows for each of the years in the three-year period
ended June 30, 2008 in conformity with accounting principles generally accepted in the United
States of America.
Mayer Hoffman McCann P.C.
Plymouth Meeting, Pennsylvania
September 29, 2008
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ESCALON MEDICAL CORP. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS
June 30, | June 30, | |||||||
2008 | 2007 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 3,708,456 | $ | 8,879,462 | ||||
Accounts receivable, net |
3,896,297 | 4,653,073 | ||||||
Inventory, net |
8,670,160 | 7,761,370 | ||||||
Other current assets |
297,807 | 469,107 | ||||||
Total current assets |
16,572,720 | 21,763,012 | ||||||
Furniture and equipment, net |
1,078,839 | 873,191 | ||||||
Goodwill |
11,590,786 | 21,072,260 | ||||||
Trademarks and trade names |
694,006 | 620,106 | ||||||
Patents, net |
157,883 | 216,228 | ||||||
Covenant not to compete and customer list, net |
1,691,610 | 326,860 | ||||||
Other assets |
110,176 | 145,556 | ||||||
Total assets |
$ | 31,896,020 | $ | 45,017,213 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Current portion of long-term debt |
$ | 501,752 | $ | 150,200 | ||||
Accounts payable |
2,628,004 | 1,626,274 | ||||||
Accrued expenses |
2,895,920 | 2,748,133 | ||||||
Total current liabilities |
6,025,676 | 4,524,607 | ||||||
Long-term debt, net of current portion |
250,871 | 0 | ||||||
Accrued post-retirement benefits |
1,087,000 | 1,087,000 | ||||||
Total long-term liabilities |
1,337,871 | 1,087,000 | ||||||
Total liabilities |
7,363,547 | 5,611,607 | ||||||
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;
6,413,930 and
6,386,857 issued and outstanding at June 30, 2008 and
June 30, 2007, respectively |
6,414 | 6,387 | ||||||
Common stock warrants |
1,601,346 | 1,601,346 | ||||||
Additional paid-in capital |
66,299,242 | 66,045,050 | ||||||
Accumulated deficit |
(43,267,466 | ) | (28,207,824 | ) | ||||
Accumulated other comprehensive (loss) |
(107,063 | ) | (39,353 | ) | ||||
Total shareholders equity |
24,532,473 | 39,405,606 | ||||||
Total liabilities and shareholders equity |
$ | 31,896,020 | $ | 45,017,213 | ||||
See notes to consolidated financial statements
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ESCALON MEDICAL CORP. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
CONSOLIDATED STATEMENTS OF OPERATIONS
For the Years Ended June 30, | 2008 | 2007 | 2006 | |||||||||
Net revenues: |
||||||||||||
Product revenue |
$ | 29,988,386 | $ | 27,892,738 | $ | 27,543,785 | ||||||
Other revenue |
222,075 | 10,945,042 | 2,246,913 | |||||||||
Revenues, net |
30,210,461 | 38,837,780 | 29,790,698 | |||||||||
Costs and expenses: |
||||||||||||
Cost of goods sold |
17,309,671 | 15,771,254 | 16,003,904 | |||||||||
Marketing, general and administrative |
14,392,004 | 13,806,399 | 13,994,788 | |||||||||
Research and development |
4,058,289 | 3,461,322 | 2,828,196 | |||||||||
Goodwill impairment |
9,574,655 | 0 | 0 | |||||||||
Total costs and expenses |
45,334,619 | 33,038,975 | 32,826,888 | |||||||||
(Loss) income from operations |
(15,124,158 | ) | 5,798,805 | (3,036,190 | ) | |||||||
Other (expense) and income: |
||||||||||||
Gain on sale of available for sale securities |
0 | 75,000 | 1,157,336 | |||||||||
Equity in Ocular Telehealth Management, LLC |
(88,206 | ) | (87,852 | ) | (173,844 | ) | ||||||
Interest income |
299,538 | 208,457 | 161,588 | |||||||||
Interest expense |
(11,827 | ) | (28,753 | ) | (63,521 | ) | ||||||
Total other (expense) income |
199,505 | 166,852 | 1,081,559 | |||||||||
Net (loss) income before taxes |
(14,924,653 | ) | 5,965,657 | (1,954,631 | ) | |||||||
Provision for income taxes |
134,990 | 51,054 | 31,309 | |||||||||
Net (loss) income |
$ | (15,059,643 | ) | $ | 5,914,603 | $ | (1,985,940 | ) | ||||
Basic net (loss) income per share |
$ | (2.36 | ) | $ | 0.93 | $ | (0.32 | ) | ||||
Diluted net (loss) income per share |
$ | (2.36 | ) | $ | 0.92 | $ | (0.32 | ) | ||||
Weighted average shares basic |
6,389,008 | 6,374,929 | 6,152,455 | |||||||||
Weighted average shares diluted |
6,389,008 | 6,434,275 | 6,152,455 | |||||||||
See notes to consolidated financial statements
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ESCALON MEDICAL CORP. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF SHAREHOLDERS EQUITY
FOR THE YEARS ENDED JUNE 30, 2008, 2007 and 2006
CONSOLIDATED STATEMENTS OF SHAREHOLDERS EQUITY
FOR THE YEARS ENDED JUNE 30, 2008, 2007 and 2006
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, 2006 |
6,344,657 | $ | 6,345 | $ | 1,601,346 | $ | 65,699,370 | $ | (34,122,427 | ) | $ | (84,527 | ) | $ | 33,100,107 | |||||||||||||
Comprehensive Income (Loss): |
||||||||||||||||||||||||||||
Net income |
0 | 0 | 0 | 0 | 5,914,603 | 0 | 5,914,603 | |||||||||||||||||||||
Change in unrealized gains on
available for sale securities |
0 | 0 | 0 | 0 | 0 | (50,220 | ) | (50,220 | ) | |||||||||||||||||||
Foreign currency translation |
0 | 0 | 0 | 0 | 0 | 95,394 | 95,394 | |||||||||||||||||||||
Total comprehensive income |
0 | 0 | 0 | 0 | 5,914,603 | 45,174 | 5,959,777 | |||||||||||||||||||||
Exercise of stock options |
42,200 | 42 | 0 | 84,692 | 0 | 0 | 84,734 | |||||||||||||||||||||
Compensation expense |
0 | 0 | 0 | 162,576 | 0 | 0 | 162,576 | |||||||||||||||||||||
Income tax benefit from exercise
of stock options |
0 | 0 | 0 | 98,412 | 0 | 0 | 98,412 | |||||||||||||||||||||
BALANCE AT JUNE 30, 2007 |
6,386,857 | 6,387 | 1,601,346 | 66,045,050 | (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 |
$ | (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 |
6,413,930 | $ | 6,414 | $ | 1,601,346 | $ | 66,299,242 | $ | (43,267,467 | ) | $ | (107,063 | ) | $ | 24,532,472 | |||||||||||||
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ESCALON MEDICAL CORP. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
CONSOLIDATED STATEMENTS OF CASH FLOWS
Years Ended June 30, | 2008 | 2007 | 2006 | |||||||||
Cash Flows from Operating Activities: |
||||||||||||
Net (loss) income |
$ | (15,059,643 | ) | $ | 5,914,603 | $ | (1,985,940 | ) | ||||
Adjustments to reconcile net income (loss) to net cash provided by (used in)
operating activities: |
||||||||||||
Depreciation and amortization |
582,511 | 590,846 | 440,952 | |||||||||
Goodwill Impairment |
9,574,655 | 0 | 0 | |||||||||
Compensation expense related to stock options |
246,757 | 162,576 | 0 | |||||||||
Gain on sale of available for sale securities |
0 | (75,000 | ) | (1,157,336 | ) | |||||||
Reserve on notes receivable |
0 | 0 | 100,000 | |||||||||
Loss on sale of assets |
28,421 | 0 | 0 | |||||||||
Loss on Ocular Telehealth Management, LLC |
88,206 | 87,852 | 173,844 | |||||||||
Change in operating assets and liabilities: |
||||||||||||
Accounts receivable, net |
939,655 | (656,830 | ) | 761,834 | ||||||||
Inventory, net |
(694,250 | ) | (638,454 | ) | (1,189,207 | ) | ||||||
Other current and long-term assets |
207,680 | 84,917 | 19,880 | |||||||||
Accounts payable, accrued expenses and other liabilities |
1,149,517 | 312,135 | 230,643 | |||||||||
Net cash (used in) provided by operating activities |
(2,936,491 | ) | 5,782,645 | (2,605,330 | ) | |||||||
Cash Flows from Investing Activities: |
||||||||||||
Proceeds from the sale of available for sale securities |
0 | 75,000 | 1,157,336 | |||||||||
Investment in Ocular Telehealth Management, LLC |
(69,000 | ) | (31,000 | ) | 0 | |||||||
Purchase of fixed assets |
(613,158 | ) | (259,705 | ) | (327,340 | ) | ||||||
Purchase of MRP, net of cash acquired |
0 | 0 | (47,060 | ) | ||||||||
Purchase of JAS Diagnostics , net of cash acquired |
(1,324,706 | ) | 0 | 0 | ||||||||
Net cash (used in) provided by investing activities |
(2,006,864 | ) | (215,705 | ) | 782,936 | |||||||
Cash Flows from Financing Activities: |
||||||||||||
Principal payments on term loans |
(150,200 | ) | (245,188 | ) | (226,749 | ) | ||||||
Issuance of common stock stock options |
7,462 | 183,146 | 374,061 | |||||||||
Net cash provided by (used in) financing activities |
(142,738 | ) | (62,042 | ) | 147,312 | |||||||
Effect of exchange rate changes on cash and cash equivalents |
(84,913 | ) | (5,146 | ) | (60,980 | ) | ||||||
Net (decrease) increase in cash and cash equivalents |
(5,171,006 | ) | 5,499,752 | (1,736,062 | ) | |||||||
Cash and cash equivalents, beginning of period |
8,879,462 | 3,379,710 | 5,115,772 | |||||||||
Cash and cash equivalents, end of period |
$ | 3,708,456 | $ | 8,879,462 | $ | 3,379,710 | ||||||
Supplemental Schedule of Cash Flow Information: |
||||||||||||
Interest paid |
$ | 11,827 | $ | 25,217 | $ | 37,586 | ||||||
Income taxes refund (paid) |
$ | (114,174 | ) | $ | 98,412 | $ | (1,133 | ) | ||||
Issuance of long-term for Jas Diagnostics acquisition |
$ | 752,623 | 0 | 0 | ||||||||
Issuance of common stock for MRP acquisition |
$ | 0 | $ | 0 | $ | 1,427,500 | ||||||
(Decrease) in unrealized appreciation on available for sale securities |
$ | 0 | $ | (50,220 | ) | $ | (1,157,097 | ) | ||||
See notes to consolidated financial statements
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Escalon Medical Corp. and Subsidiaries
Notes to Consolidated Financial Statements
Notes to Consolidated Financial Statements
1. Organization and Description of Business and Business Conditions
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 (which includes the acquisition of Jas Diagnostics, see footnote 11). All
inter-company 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.
In connection with the presentation of the current period consolidated financial statements,
certain prior period balances have been reclassified to conform to current period presentation.
The Drew business unit has experienced significant losses and negative cash flow from
operations in the last three years. On June 19, 2008 Management implemented cost reductions at
Drews Dallas, TX location in order to bring Drews cost structure in line with anticipated
revenues. Management anticipates that these cuts combined with budgeted profits in the other
Escalon entities will provide sufficient liquidity in the coming fiscal year.
2. 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.
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Fair Value of Financial Instruments
The Company follows Statement of Financial Accounting Standards No. 107 (SFAS 107),
Disclosure about Fair Value of Financial Instruments. 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 value of available
for sale securities approximates market based-upon market arms-length transactions in the
underlying security. 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.
Marketable Securities
The Company reports debt and marketable securities in accordance with Statement of Financial
Accounting Standards No. 115 (SFAS 115), Accounting for Certain Investments in Debt and Equity
Securities. All of the equity securities held by the Company at June 30, 2007 and 2006 are
classified as available for sale securities. Accordingly, amounts are reported at fair value, with
unrealized gains and losses excluded from earnings and reported as a separate component of
shareholders equity (see note 15).
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. |
With respect to additional consideration related to the sale of Silicone Oil by Bausch & Lomb
and the licensing of the Companys intellectual laser technology, revenue is recognized upon
notification from the other parties of amount earned or upon receipt of royalty payments.
Provision has been made for estimated sales returns based on historical experience.
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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, | ||||||||
2008 | 2007 | |||||||
Raw materials |
$ | 6,024,784 | $ | 4,825,018 | ||||
Work in process |
759,619 | 680,994 | ||||||
Finished goods |
2,353,581 | 2,556,913 | ||||||
9,137,984 | 8,062,925 | |||||||
Valuation allowance |
(467,824 | ) | (301,555 | ) | ||||
Total inventory |
$ | 8,670,160 | $ | 7,761,370 | ||||
Valuation allowance activity for the years ended June 30 was as follows:
June 30, | ||||||||
2008 | 2007 | |||||||
Balance, July 1 |
$ | 301,555 | $ | 252,712 | ||||
Provision for valuation allowance |
172,670 | 65,221 | ||||||
Write-offs |
(6,401 | ) | (16,378 | ) | ||||
Balance, June 30 |
$ | 467,824 | $ | 301,555 | ||||
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. Credit losses, when realized, have been
within the range of managements expectations. Allowance for doubtful accounts activity for the
years ended June 30 was as follows:
June 30, | ||||||||
2008 | 2007 | |||||||
Balance, July 1 |
$ | 566,878 | $ | 649,577 | ||||
Provision for bad debts |
153,168 | 96,000 | ||||||
Write-offs |
(246,859 | ) | (178,699 | ) | ||||
Balance, June 30 |
$ | 473,187 | $ | 566,878 | ||||
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
45
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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, 2008, 2007 and 2006 was $582,511, $394,517 and
$324,458 respectively.
Property and equipment consist of the following at:
June 30, | ||||||||
2008 | 2007 | |||||||
Equipment |
$ | 2,788,606 | $ | 2,157,562 | ||||
Furniture and Fixtures |
62,846 | 62,846 | ||||||
Leasehold Improvements |
121,702 | 135,895 | ||||||
2,973,154 | 2,356,303 | |||||||
Less: Accumulated depreciation and amortization |
(1,894,315 | ) | (1,483,112 | ) | ||||
$ | 1,078,839 | $ | 873,191 | |||||
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.
Intangible Assets
The Company follows Statement of Financial Accounting Standards No. 142 (SFAS 142),
Goodwill and Other Intangible Assets, which discontinues the amortization of goodwill and
identifiable intangible assets that have indefinite lives. In accordance with SFAS 142, these
assets are tested for impairment on an annual basis. See footnote 3 for details on Goodwill
impairment charge related to Drew.
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
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Effective July 1, 2006, the Company adopted the fair value recognition provisions of SFAS
123(R), using the modified prospective transition method. Under this transition method, stock
based compensation expense for the year ended June 30, 2007 included 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. On June
30, 2006, the Compensation Committee of the Company approved the acceleration of vesting of all of
the outstanding stock options to purchase shares of the Companys common stock. The acceleration
applied to all stock options outstanding as of June 30, 2006 under the Companys 1991 Stock Option
Plan, 1992 Stock Option Plan, 1993 Stock Option Plan, 1999 Stock Option Plan and 2004 Equity
Incentive Plan. Since all options issued prior to July 1, 2006 were accelerated, and therefore
fully vested, there was no compensation expense recorded in fiscal year 2007 related to these
options.
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 SFAS 123(R).
As of June 30, 2008, there was $266,348 of total unrecognized compensation cost related to
non-vested share-based compensation arrangements under the plans. The cost is expected to be
recognized over a weighted average period of four years.
The Company measures compensation expense for its non-employee stock-based compensation under
the Financial Accounting Standards Board (FASB) Emerging Issues Task Force (EITF) Issue No. 96-18,
Accounting for Equity Instruments that are Issued to Other Than Employees for Acquiring, or in
Conjunction with Selling, Goods or Services . The fair value of the option issued 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 performance is complete.
The fair value of the equity instrument is charged directly to compensation expense and additional
paid-in capital.
For the year ended June 30, 2006 the Company reported stock-based compensation through the
disclosure-only requirements of the Statement of Financial Accounting Standards No. 123 (SFAS
123), Accounting for Stock-Based Compensation, as amended by Statement of Financial Accounting
Standards No. 148 (SFAS 148), Accounting for Stock-Based Compensation Transition and
Disclosure an Amendment to FASB No. 123. Compensation expense for options is measured using
the intrinsic value method in accordance with Accounting Principles Board Opinion No. 25,
Accounting for Stock Issued to Employees (APB 25). Under APB 25, because the exercise price of
the Companys employee stock options is generally equal to the market price of the Companys
underlying stock on the date of grant, no compensation expense is recognized.
SFAS 123 establishes an alternative method of expense recognition for stock-based compensation
awards based on fair values. The following table illustrates the impact on net income and earnings
per share if the Company had applied the fair value recognition provisions of SFAS 123.
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2006 | ||||
Net (loss), as reported |
$ | (1,985,940 | ) | |
Deduct: Total stock-based employee compensation
expense determined under fair value based method
for all awards, net of related tax effects |
(288,848 | ) | ||
Pro forma net (loss) |
$ | (2,274,788 | ) | |
(Loss) per share: |
||||
Basic as reported |
$ | (0.323 | ) | |
Basic pro forma |
$ | (0.370 | ) | |
Diluted as reported |
$ | (0.323 | ) | |
Diluted pro forma |
$ | (0.370 | ) | |
The Company has followed the guidelines of SFAS 123 to establish the valuation of its stock
options. The fair value of these equity awards was estimated at the date of grant using these
Black-Scholes option pricing method. For the purposes of pro forma disclosures, the estimated fair
value of the equity awards is amortized to expense over the options vesting period. For the
purposes of applying SFAS 123, the estimated per share value of the options granted during the
fiscal years ended June 30, 2006 was $5.52. The fair value was estimated using the following
assumptions: dividend yield of 0.0%; volatility ranging between 0.60 and 2.51; risk free interest
ranging between 3.30% and 4.5%; and expected life of 10 years. The volatility assumption is based
on volatility seen in the Companys stock over the last five years. This assumption was made
according to the guidance of SFAS 123. There is no reason to believe that future volatility will
compare to historic volatility.
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, 2008, 2007 and 2006 was $173,054, $134,811 and $279,670, 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, 2008, 2007 and 2006 is as follows:
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2008 | 2007 | 2006 | ||||||||||
Basic Weighted average shares outstanding |
6,389,008 | 6,374,929 | 6,152,455 | |||||||||
Effect of dilutive securities Stock options and warrants |
0 | 59,346 | 0 | |||||||||
Diluted weighted average shares outstanding |
6,389,008 | 6,434,275 | 6,152,455 | |||||||||
For the years ended June 30 2008, 2007 and 2006 the impact of all dilutive securities were
omitted from the diluted earnings per share calculation as they reduce the loss per share
(anti-dilutive). As of June 30, 2008, 2007 and 2006, 120,000 warrants, which were issued in March
2004 (see note 6), to purchase shares of Escalon common stock were outstanding. 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
The Company accounts for income taxes using the asset and liability method. Under this
method, deferred tax assets and liabilities are recognized based on the difference between the
financial statement carrying amounts of existing assets and liabilities and their respective tax
bases. Deferred tax assets and liabilities are measured using enacted rates in effect in the years
when those temporary differences are expected to reverse. The impact on deferred taxes of a change
in tax rates, should a change occur, is recognized in income in the period that include the
enactment date.
Comprehensive Income
The Company reports comprehensive income in accordance with the provision of SFAS No.130,
Reporting Comprehensive Income, which establishes standards for reporting comprehensive income
and its component in financial statements. Comprehensive income, as defined, includes all changes
in equit 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.
New Accounting Pronouncements
In December 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 141(R),
Business Combinations (SFAS 141(R)). SFAS 141(R) will significantly change the accounting for
business combinations in a number of areas including the treatment of contingent consideration,
contingencies, acquisition costs, in-process research and development and restructuring costs. In
addition, under SFAS 141(R), changes in deferred tax asset valuation allowances and acquired income
tax uncertainties in a business combination after the measurement period will impact income tax
expense. SFAS 141(R) applies prospectively to business combinations for which the acquisition date
is on or after the beginning of the first annual reporting period beginning on or after December
15, 2008. Early application is not permitted. The effect of SFAS 141(R) on our consolidated
financial statements will be
49
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dependent on the nature and terms of any business combinations that we
consummate on or after July 1, 2009.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements (SFAS 160). SFAS 160 amends Accounting Research Bulletin No. 51 to establish
accounting and reporting standards for the noncontrolling (minority) interest in a subsidiary and
for the deconsolidation of a subsidiary. It clarifies that a noncontrolling interest in a
subsidiary is an ownership interest in the consolidated entity that should be reported as equity in
the consolidated financial statements and establishes a single method of accounting for changes in
a parents ownership interest in a subsidiary that do not result in deconsolidation. SFAS 160 is
effective for fiscal years beginning on or after December 15, 2008. We do not expect the adoption
of SFAS 160 to have a significant impact on our consolidated financial statements unless a future
transaction results in a noncontrolling interest in a subsidiary.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities Including an Amendment of FASB Statement No. 115 (SFAS No. 159). SFAS No.
159 permits a company to choose to measure many financial instruments and other items at fair value
that are not currently required to be measured at fair value. The objective is to improve financial
reporting by providing a company with the opportunity to mitigate volatility in reported earnings
caused by measuring related assets and liabilities differently without having to apply complex
hedge accounting provisions. SFAS No. 159 is effective for fiscal years beginning after November
15, 2007 and, accordingly,
we adopted the provisions of this Statement on July 1, 2008. We are currently evaluating the
impact of the adoption of SFAS No. 159 on our consolidated financial statements. However, we do not
expect the effect to be significant.
In June 2007, the FASB ratified Emerging Issues Task Force Issue 07-3, Accounting for Advance
Payments for Goods or Services to Be Used in Future Research and Development Activities (EITF
07-3). EITF 07-3 provides guidance on the capitalization of non-refundable advance payments for
goods and services to be used in future research and development activities until such goods have
been delivered or the related services have been performed. As applicable to us, this pronouncement
became effective for our fiscal year beginning on July 1, 2008. We do not expect the adoption of
this pronouncement to have a material effect on our consolidated financial statements.
In July 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxesan interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the accounting for
uncertainty in income taxes recognized in the enterprises financial statements. This
Interpretation prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to be taken in the tax
return. We adopted the provisions of FIN 48 on July 1, 2007. As of the date of adoption, the
2005-2007 tax years remain subject to examination by major tax jurisdictions. As of June 30, 2008,
the 2005-2007 tax years remain subject to examination by major tax jurisdictions.
As a result of the implementation of FIN 48, we recognized no material adjustments in the
liability for unrecognized income tax benefits and, at the adoption date of July 1, 2008, we had no
unrecognized tax benefits which would have affected our effective tax rate if recognized. At June
30, 2008, we also had no unrecognized tax benefits. If uncertain tax positions had been recorded,
then we would recognize interest and penalties related to uncertain tax positions in income tax
expense. As of June 30, 2008, no accrued interest related to uncertain tax positions has been
recorded.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS No. 157).
SFAS No. 157 establishes a framework for measuring fair value and expands the disclosures on fair
value measurements. SFAS No. 157 is effective for fiscal years beginning after November 15, 2007
and, accordingly, we adopted the provisions of this Statement on July 1, 2008. We are currently
evaluating the impact of the adoption of SFAS No. 157 on our consolidated financial statements.
However, we do not expect the effect to be significant.
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3. 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 SFAS 142 effective July 1, 2001. Under SFAS 142, goodwill and identified
intangible assets that have indefinite lives are no longer amortized but reviewed for impairment
annually or more frequently if certain indicators arise.
In accordance with SFAS 142, 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 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 Drew exceeded their fair values 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.
SFAS No. 142 makes use of the concept of reporting units. All acquisitions must be assigned to
a reporting unit or units. Reporting units have been defined under the standards to be the same as
or one level below an operating segment, as defined in SFAS No. 131, Disclosures About Segments of
an Enterprise and Related Information (SFAS No. 131). As of June 30, 2007, the Company had total
goodwill of $21,072,260, of which $9,574,655 was assigned to Drew, $9,525,550 was assigned to
Sonomed, $1,030,837 was assigned to EMI and $941,218 is assigned to Vascular.
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 unit 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 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 unit, including profit margins, long-term
forecasts, discount rates and terminal growth rates, reflect the Companys best estimates.
The following table presents unamortized intangible assets by business unit as of June 30,
2008 and 2007:
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2008 | 2007 | |||||||
Net | Net | |||||||
Carrying | Carrying | |||||||
Amount | Amount | |||||||
Goodwill |
||||||||
Sonomed |
$ | 9,525,550 | $ | 9,525,550 | ||||
Drew |
0 | 9,574,655 | ||||||
JAS-subsidiary of Drew |
93,181 | 0 | ||||||
Vascular |
941,218 | 941,218 | ||||||
Medical/Trek/EMI |
1,030,837 | 1,030,837 | ||||||
Total |
$ | 11,590,786 | $ | 21,072,260 | ||||
2008 | 2007 | |||||||
Net | Net | |||||||
Carrying | Carrying | |||||||
Amount | Amount | |||||||
Trademarks and tradenames |
||||||||
Sonomed |
$ | 601,806 | $ | 616,906 | ||||
JAS-subsidiary of Drew |
89,000 | 0 | ||||||
Medical/Trek/EMI |
3,200 | 3,200 | ||||||
Total |
$ | 694,006 | $ | 620,106 | ||||
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 $424,074 and $365,729 at June 30, 2008 and 2007, respectively. Amortization
expense for the years ended June 30, 2008, 2007 and 2006 was $89,123, $98,404 and $75,150,
respectively.
Amortization
expense, relating entirely to patents, is estimated to be
approximately $58,000 for 2009 thru 2011 and $17,000 for 2012.
Covenant Not to Compete and Customer List
The Company recorded the value of a covenant not to compete and a customer lists as intangible
assets as part of the acquisition of MRP and JAS (See note 11). The valuation was based on the
fair market value of these assets at the time of acquisition. These assets are amortized over
their estimate useful lives, not exceeding 5 years, on a straight-line basis from the date of
acquisition. Accumulated amortization was $212,756 and $116,109 at June 30, 2008 and 2007,
respectively. Amortization expense for the years ended June 30, 2008, 2007 and 2006 was $96,647,
$93,213 and $22,986, respectively.
Amortization expense, relating entirely to covenant not to compete and the customer list is
estimated to be approximately $93,000 each for the years 2009 thru 2010 and $47,000 for 2011.
The following table presents amortized intangible assets by business unit as of June 30, 2008:
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Adjusted | ||||||||||||||||||||
Gross | Gross | |||||||||||||||||||
Carrying | Carrying | Accumulated | Net Carrying | |||||||||||||||||
Amount | Impairment | Amount | Amortization | Value | ||||||||||||||||
Amortized Intangible Assets Patents |
||||||||||||||||||||
Drew |
$ | 0 | $ | 0 | $ | 0 | $ | 0 | $ | 0 | ||||||||||
Vascular |
0 | 0 | 0 | 0 | 0 | |||||||||||||||
Medical/Trek/EMI |
215,050 | 0 | 215,050 | (57,167 | ) | 157,883 | ||||||||||||||
Total |
$ | 215,050 | $ | 0 | $ | 215,050 | $ | (57,167 | ) | $ | 157,883 | |||||||||
Covenant Not To Compete/Customer List |
||||||||||||||||||||
JAS |
$ | 1,461,397 | $ | 0 | $ | 1,461,397 | $ | 0 | $ | 1,461,397 | ||||||||||
EMI |
442,969 | 0 | 442,969 | (212,756 | ) | 230,213 | ||||||||||||||
Total |
$ | 1,904,366 | $ | 0 | $ | 1,904,366 | $ | (212,756 | ) | $ | 1,691,610 | |||||||||
The following table presents amortized intangible assets by business unit as of June 30, 2007:
Adjusted | ||||||||||||||||||||
Gross | Gross | |||||||||||||||||||
Carrying | Carrying | Accumulated | Net Carrying | |||||||||||||||||
Amount | Impairment | Amount | Amortization | Value | ||||||||||||||||
Amortized Intangible
Assets Patents |
||||||||||||||||||||
Drew |
$ | 279,740 | $ | 0 | $ | 279,740 | $ | (154,474 | ) | $ | 125,266 | |||||||||
Vascular |
36,916 | 0 | 36,916 | (36,916 | ) | 0 | ||||||||||||||
Medical/Trek/EMI |
265,301 | 0 | 265,301 | (174,339 | ) | 90,962 | ||||||||||||||
Total |
$ | 581,957 | $ | 0 | $ | 581,957 | $ | (365,729 | ) | $ | 216,228 | |||||||||
Covenant Not To
Compete/ Customer
List |
||||||||||||||||||||
EMI |
$ | 442,969 | $ | 0 | $ | 442,969 | $ | (116,109 | ) | $ | 326,860 | |||||||||
Total |
$ | 442,969 | $ | 0 | $ | 442,969 | $ | (116,109 | ) | $ | 326,860 | |||||||||
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4. Accrued Expenses
The following table presents accrued expenses:
June 30, 2008 | June 30, 2007 | |||||||
Accrued compensation |
$ | 1,531,886 | $ | 1,694,394 | ||||
Warranty accruals |
255,740 | 255,740 | ||||||
Legal accruals |
464,338 | 0 | ||||||
Other accruals |
643,956 | 797,999 | ||||||
Total accrued expenses |
$ | 2,895,920 | $ | 2,748,133 | ||||
In addition to normal accruals, other accruals as of June 30, 2008 and 2007 relate to the
remaining lease payments on a facility that ceased manufacturing operations prior to the Drew
acquisition, accruals for litigation existing prior to the Drew acquisition, franchise and ad
valorem tax accruals and other sundry operating expenses accruals.
Accrued compensation as of June 30, 2008 and 2007 primarily relates to payroll, bonus and
vacation accruals, and payroll tax liabilities.
5. Long-Term Debt
The Company had two long-term debt facilities through its Drew subsidiary: the Texas Mezzanine
Fund and Symbiotics, Inc. The Texas Mezzanine Fund debt provided for interest at fixed rate of 8%
per annum until July 1, 2005. The interest rate was then adjusted to the prime rate plus 4% per
annum. Each June 1, the rate was adjusted to the prime rate plus 4% per annum. The debt has a
minimum interest rate of 8% per annum to a maximum interest rate of 18% per annum. The interest
rate on the Texas Mezzanine Fund was 12% per annum and 10.25% per annum as of June 30, 2007 and
2006, respectively. Drew was required to pay an additional interest payment to the Texas Mezzanine
Fund of 1% of fiscal year revenues over $11,500,000 as defined in a revenue participation
agreement. The note was paid in ful in April 2008. The outstanding balance of the note was $0 and
$133,534 as of June 30, 2008 and 2007, respectively. The Symbiotics, Inc. term debt, which
originated from the acquisition of a product line from Symbiotics, Inc., was payable in monthly
installments of $8,333 with interest at a fixed rate of 5% per annum. The outstanding balance of
this note was $0 and $16,666 as of June 30, 2008 and 2007, respectively.
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 is payable in
six quarterly installments of $124,437 plus interest at the prime rate (5% on June 30, 2008) as
published by the Bank of America.
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The schedule below presents principal amortization for the next two years under each of the
Companys loan agreements as of June 30, 2008:
Twelve Months | |||||||
Ending | Former JAS | ||||||
June 30, | Shareholders | Total | |||||
2009 |
$ | 501,752 | $ | 501,752 | |||
2010 |
250,871 | 250,871 | |||||
Total |
$ | 752,623 | 752,623 | ||||
Current portion of long-term debt |
501,752 | ||||||
Long-term portion |
$ | 250,871 |
6. Capital Stock Transactions
Stock Option Plans
As of June 30, 2008, Escalon had in effect five employee stock option plans which 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, 2008. 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 option is exercisable over a period no longer than 10 years after the grant date. As
of June 30, 2008, options to purchase 997,077 shares of the Companys common stock were outstanding
of which 892,019 where exercisable, and 284,075 shares were reserved for future grants.
On June 30, 2006, the Compensation Committee of the Company approved the acceleration of
vesting of all of the outstanding stock options to purchase shares of the Companys common stock.
The acceleration applies to all stock options outstanding as of June 30, 2006 under the Companys
1991 Stock Option Plan, 1992 Stock Option Plan, 1993 Stock Option Plan, 1999 Stock Option Plan and
2004 Equity Incentive Plan.
The Company took this action in order to reduce the future compensation expense associated
with unvested stock options following the adoption of Statement of Financial Accounting Standards
No. 123, Share Based Payment (revised 2004) (SFAS 123R). The Company was required to apply the
expense recognition provisions of SFAS 123R beginning in the first quarter of fiscal 2007. As a
result of the acceleration, the Company expects to reduce the stock option expense it otherwise
would be required to record in connection with the accelerated options by approximately $1.18
million over the original option vesting periods.
The Companys Board of Directors took this action with the belief that it is in the best
interest of our shareholders, as it will reduce the Companys reported compensation expense in
future periods. In addition, because some of these options have exercise prices in excess of the
current market value, the Board also believed that these options might not have been fully
achieving the Companys original objective of employee retention and incentive compensation. The
senior officers of the Company who are subject to reporting under Section 16(a) of the Securities
Exchange Act of 1934 ( the Exchange Act) will be subject to the following restriction with
respect to the sale of shares purchased upon exercise of a stock option whose vesting has been
accelerated: Such sale shall be prohibited until the earlier of: (i) the date on
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which the option
would otherwise have vested; (ii) twelve months from the date of the extension; or (iii)
termination of employment.
The following is a summary of the Companys stock option activity and related information for
the fiscal years ended June 30, 2008, 2007 and 2006:
2008 | 2007 | 2006 | ||||||||||||||||||||||
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 |
865,035 | $ | 5.53 | 920,685 | $ | 5.73 | 847,210 | $ | 4.20 | |||||||||||||||
Granted |
135,500 | $ | 3.05 | 117,000 | $ | 2.65 | 318,400 | $ | 6.63 | |||||||||||||||
Exercised |
(2,458 | ) | $ | 3.02 | (42,000 | ) | $ | 2.00 | (121,183 | ) | $ | 2.22 | ||||||||||||
Forfeited |
(1,000 | ) | $ | 3.05 | (130,650 | ) | $ | 5.52 | (123,742 | ) | $ | 1.00 | ||||||||||||
Outstanding at the end of the year |
997,077 | $ | 5.27 | 865,035 | $ | 5.53 | 920,685 | $ | 5.73 | |||||||||||||||
Exercisable at the end of the year |
892,019 | 810,227 | 920,685 | |||||||||||||||||||||
Weighted average fair value of
options
granted during the year |
$ | 3.05 | $ | 2.65 | $ | 6.63 |
The following table summarizes information about stock options outstanding as of June 30,
2008:
Weighted | ||||||||||||||||||||
Number | Average | |||||||||||||||||||
Outstanding | Remaining | Weighted | Number | Weighted | ||||||||||||||||
at | Contractual | Average | Exercisable | Average | ||||||||||||||||
June, 30 | Life | Exercise | at June 30, | Exercise | ||||||||||||||||
2008 | (Years) | Price | 2008 | Price | ||||||||||||||||
Range of Exercise Prices |
||||||||||||||||||||
$1.45 to $2.12 |
119,756 | 2.23 | $ | 1.88 | 119,756 | $ | 1.88 | |||||||||||||
$2.37 to $2.77 |
377,942 | 6.95 | $ | 2.77 | 272,884 | $ | 2.71 | |||||||||||||
$4.97 to $5.59 |
73,000 | 7.28 | $ | 5.05 | 73,000 | $ | 5.05 | |||||||||||||
$6.19 to $6.19 |
168,250 | 6.08 | $ | 6.19 | 168,250 | $ | 6.19 | |||||||||||||
$6.94 to $8.06 |
258,129 | 6.47 | $ | 7.41 | 258,129 | $ | 7.41 | |||||||||||||
Total |
997,077 | 892,019 | ||||||||||||||||||
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Sale of Common Stock and Warrants
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. If not
exercised, the warrants expire 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 securities Act). The Company has subsequently filed a registration statement with
the SEC, 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.
7. Income Taxes
The provision for income taxes for the years ended June 30, 2008, 2007 and 2006 consists of
the following:
2008 | 2007 | 2006 | ||||||||||
Current income tax provision |
||||||||||||
Federal |
$ | | $ | | $ | | ||||||
State |
$ | 134,990 | 51,054 | 31,309 | ||||||||
134,990 | 51,054 | 31,309 | ||||||||||
Deferred income tax provision |
||||||||||||
Federal |
130,565 | 1,704,463 | (1,962,685 | ) | ||||||||
State |
30,626 | 399,812 | (460,383 | ) | ||||||||
Change in valuation allowance |
(161,191 | ) | (2,104,275 | ) | 2,423,068 | |||||||
— | — | — | ||||||||||
Income tax expense |
$ | 134,990 | $ | 51,054 | $ | 31,309 | ||||||
Income taxes as a percentage of income for the years ended June 30, 2008, 2007 and 2006 differ
from statutory federal income tax rate due to the following:
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2008 | 2007 | 2006 | ||||||||||
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, 2008, the Company had deferred income tax assets of $12,496,702. The deferred
income tax assets have been reduced by a $10,446,340 valuation allowance. 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, 2008
and 2007 are as follows:
2008 | 2007 | |||||||||||
Deferred income tax assets: |
||||||||||||
Net operating loss carryforward |
$ | 10,964,351 | $ | 11,063,841 | ||||||||
Accrued bonus |
188,411 | 62,560 | ||||||||||
Executive post retirement costs |
369,580 | 369,580 | ||||||||||
General business credit |
450,199 | 450,199 | ||||||||||
Allowance for doubtful accounts |
160,884 | 90,734 | ||||||||||
Accrued vacation |
174,003 | 158,885 | ||||||||||
Inventory reserve |
159,060 | 83,318 | ||||||||||
Accelerated depreciation |
3,782 | 41,967 | ||||||||||
Warranty reserve |
26,432 | 26,432 | ||||||||||
Total deferred income tax assets |
12,496,702 | 12,347,516 | ||||||||||
Valuation allowance |
(10,446,340 | ) | (10,607,531 | ) | ||||||||
2,050,362 | 1,739,985 | |||||||||||
Deferred income tax liabilities: |
||||||||||||
Accelerated amortization |
(2,050,362 | ) | (1,739,985 | ) | ||||||||
Total deferred income tax liabilities |
(2,050,362 | ) | (1,739,985 | ) | ||||||||
$ | | $ | | |||||||||
As of June 30, 2008, the Company has a valuation allowance of $10,446,340, 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
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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 $31,121,000 and $4,287,000, respectively,
of which $18,747,000 and $2,009,000, respectively, will expire over the next ten years, and
$12,374,000 and $2,278,000, respectively, will expire in years eleven through twenty.
Approximately $6,800,000 of federal net operating losses expired June 30, 2008. Not included in the
$31,121,000 federal net operating loss is approximately $8.2 million federal NOL carry forward at
June 30, 2008 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.
Effective July 1, 2007, the Company adopted the provisions of FASB Interpretation No. 48,
Accounting for Uncertainties in Income Taxes (FIN 48), an interpretation of FASB Statement No.
109 (SFAS 109). FIN 48 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 FIN 48 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 2005. 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, 2008, 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.
8. 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 amounts to be paid under
these arrangements as of June 30, 2008 are as follows:
Lease | ||||
Twelve Months Ending | Obligations | |||
2009 |
$ | 682,231 | ||
2010 |
656,014 | |||
2011 |
654,134 | |||
2012 |
633,267 | |||
2013 |
489,579 | |||
Thereafter |
303,274 | |||
Total |
$ | 3,418,499 | ||
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Rent expense charged to operations during the years ended June 30, 2008, 2007 and 2006 was
approximately $782,000, $866,000 and $890,000, respectively.
Contingencies
Royalty Agreement: Clinical Diagnostics Solutions
Drew and Clinical Diagnostics Solutions, Inc. (CDS) entered into a Private Label
Manufacturing Agreement dated April 1, 2002 for the right to sell formulations or products of CDS
including reagents, controls and calibrators (CDS products) on a private label basis. The
agreement term
is 15 years and automatically renews year-to-year thereafter. Drew is obligated to pay CDS a
royalty of 7.5% on all sales of CDS products produced from Drews United Kingdom facility.
PointCare Technologies, Inc. Legal Proceedings
On February 13, 2008, Escalons wholly owned subsidiary, Drew Scientific (Drew), filed an
Order to Show Cause for Preliminary Injunction and Temporary Restraining Order and a Complaint
against PointCare Technologies, Inc. (PCT) (Drew Scientific, Inc. v. PointCare Technologies,
Inc. (08 CV 1490, S.D.N.Y)). In its pleadings, Drew petitioned the Court to require PCT to
honor its obligations to Drew under the Agreement that the parties executed in June 2006 and
further sought a ruling that PCT has breached its contractual obligations to Drew, that PCT has
intentionally acted in bad faith, and that PCT is liable to Drew for damages resulting from its
breach of its contractual obligations to Drew. PCT has denied the allegations set forth by Drew
and has asked the Court to declare that PCT properly terminated its Agreement with Drew and that it
owes no further duties and has no further obligations to Drew.
The Agreement between Drew and PCT was intended to combine the efforts of the parties in two
significant but related respects. In the first respect, Drew agreed to modify its Excell 22
TM hematology platform to accommodate PCTs proprietary CD4 Lymphocyte Assay, CD4
sure.TM The integrated device is intended for use in the diagnosis of patients with HIV
infection, particularly in a hospital setting. Drew asserts that the development of the device is
a joint responsibility, with both Drew and PCT having allocated responsibilities between them (PCT
being responsible for assuring that the CD4 assay is compatible with the HT instrumentation). Two
different versions of the integrated device, referred to collectively as a high throughput (HT)
platform, are to be marketed and sold by the respective parties in assigned territories. Drew has
thus far invested approximately $1,000,000 in this initiative.
The second significant aspect relates to PCTs Near Patient (NP) platform, which permits
the same type of patient care testing for HIV to be performed locally, i.e., in a non-hospital
environment. Once developed and after receiving required regulatory approvals, PCT agreed to
privately label and sell NP instruments to Drew, which was granted certain product distribution
rights, including the right to be the entity primarily responsible for the marketing and sales of
the NP platform in the United States, the United Kingdom, Europe and much of Asia. Drew has
already invested in NP marketing efforts and lined up potential customers. Important to the
present dispute is the fact that there is a significant technological overlap between the HT and NP
devices, and to some extent, they are competitive. For this reason, the Agreement allocates
territories to the parties and the party designated for a specific territory is primarily
responsible for the marketing and sale of both systems in that assigned territory.
In June 2007, PCT unilaterally shifted its personnel and resources away from the joint
development of the HT instrument, diverting these resources instead to the development of its own
NP instrument. Drew believes that at about this time, PCT also began to solicit its own
distributors to act on its behalf in the Drew territories. PCT received FDA approval to market its
NP instrument in December 2007.
In November 2007, PCT asserted that Drew was not in compliance with its contractual
obligations under the Agreement. Specifically, PCT claimed that Drew was not in compliance with
the HT development timeline. Drew denied this claim, noting that PCTs own conduct contributed
materially to the fact that the HT project timeline had to be extended. Further, Drew responded
that PCTs repeated
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refusal to complete critical software development and to cooperate with Drew
with respect to the necessary integration of such software into the HT instrument remained critical
violations by PCT of its contractual obligations, frustrating any effort by Drew to complete the HT
project.
Despite Drews attempts to resolve outstanding issues with PCT amicably, PCT informed Drew in
December 2007, shortly after receiving approval of its own NP instrument, that PCT deemed the
Agreement between the parties to be terminated, that PCT would not take the necessary steps to
assist Drew to complete the HT instrument project and that PCT would not allow Drew to market or
sell the NP instrument within the territories that were granted to Drew under the Agreement.
Drew filed its legal actions against PCT in February 2008, alleging that PCTs conduct is
intended to irreparably harm Drews ability to bring the HT instrument into the marketplace and
thus allow PCT to gain a competitive advantage for its NP instrument. Drew further alleges that
PCTs actions are intended to deny Drew the economic benefits associated with its marketing rights
relative to both the HT and NP products. Consequently, Drew claims that PCTs actions have and
will continue to harm its reputation and that in addition to its lost profits, Drew is threatened
with the loss of the significant economic resources that it has already committed to the
development and marketing of both the HT and the NP instrument, as well as other irreparable harm.
After a brief period of discovery and the submission of legal papers, the Court issued a
ruling on May 6, 2008. While denying Drews request for a Preliminary Injunction, the Court
scheduled the dispute for expedited trial. The Court also requested that the parties undertake a
mediation proceeding in an attempt to amicably resolve the dispute. Both parties have agreed to
participate in mediation. Should the mediation prove unsuccessful, the parties will proceed to
trial as scheduled. The parties are making progress on achieving an
amicable resolution to this matter. The parties, therefore have
requested and been granted an indefinite extension if a full and
final resolution can be achieved by the parties.
The Company is cognizant of the legal expenses and costs associated with the PCT litigation. The
Company, however, believes that Drew is taking all necessary actions to protect its rights and
interests under the Agreement with PCT. The Company believes, however, that it
is necessary to pursue this litigation and possible final resolution: a) to protect the significant R&D expenditure that Drew has
already invested in the development of the HT Instrument; b) to prevent PCT from denying Drew
access to PCTs NP Instrument; c) protect Drews territorial rights, as well as its reputation in
such markets; and d) allow Drew to receive the economic benefits that it is entitled to with
respect to both the HT and NP instruments
Intralase Corp. Legal Proceedings
In 1997, Intralase and the Company entered into an agreement under which Intralase became the
exclusive licensee of certain patents, technology and intellectual property owned by Escalon
Medical. This agreement was amended and restated in October 2000. Disputes arose between the
parties culminating in litigation between the parties.
On February 27, 2007 the Company entered into an agreement with Intralase to settle all
outstanding disputes and litigation between the parties. Under the settlement agreement, Intralase
made a lump-sum payment to the Company of $9,600,000 in exchange for which all pending litigation
between the parties was dismissed, the parties exchanged general releases, the Company transferred
to Intralase its ownership of all patents and intellectual property formerly licensed to Intralase
by the Company, and the license agreement was terminated. In addition, the payment from Intralase
satisfies all outstanding past, current and future royalties owed or alleged to be owed by
Intralase to the Company.
Other 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.
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9. Retirement and Post-Retirement Plans
The Company adopted a 401(k) retirement plan effective January 1, 1994. Escalon 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, Escalon 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 contribution for the fiscal years ended June
30, 2008, 2007 and 2006 was $36,699, $36,702 and $35,034, 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, 2008, 2007 and 2006 was $31,242, $29,794 and
$10,000, 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 at age 65 or older, 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. |
In fiscal 2005 the Company accrued $1,087,000, which represents the present value of the
supplemental retirement benefits awarded. This amount is accrued at June 30, 2008 and 2007.
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10. Sale of Silicone Oil Product Line, Licensing of Laser Technology and Other Revenue
Sale of Silicone Oil Product Line
In the first quarter of fiscal 2000, Escalon received $2,117,000 from the sale to Bausch &
Lomb of its license and distribution rights for the Silicone Oil product line. This sale resulted
in a $1,864,000 gain after writing off the remaining net book value of license and distribution
rights associated with that product line. The Companys contract to receive additional
consideration based on sales of Silicone Oil by Bausch & Lomb expired on August 12, 2005.
The agreement with Bausch & Lomb, which commenced on August 13, 2000, was structured so that
the Company received consideration from Bausch & Lomb based on its adjusted gross profit from its
sales of Silicone Oil on a quarterly basis. The consideration was subject to a factor, which
stepped down according to the following schedule:
From 8/13/00 to 8/12/01 |
100 | % | ||
From 8/13/01 to 8/12/02 |
82 | % | ||
From 8/13/02 to 8/12/03 |
72 | % | ||
From 8/13/03 to 8/12/04 |
64 | % | ||
From 8/13/04 to 8/12/05 |
45 | % |
Royalties received from Silicone Oil during 2008, 2007 and 2006 were $0, $0 and $203,000,
respectively.
Intralase: Licensing of Laser Technology
In 1997, Intralase and the Company entered into an agreement under which Intralase became the
exclusive licensee of certain patents, technology and intellectual property owned by Escalon
Medical. This agreement was amended and restated in October 2000. Disputes arose between the
parties culminating in litigation between the parties.
As part of the settlement agreement described in footnote 8 of these financial statements, on
February 27, 2007 the Company transferred to Intralase its ownership of all patents and
intellectual property formerly licensed to Intralase by the Company, and the license agreement was
terminated. In addition, the settlement payment from Intralase satisfies all outstanding past,
current and future royalties owed or alleged to be owed by Intralase to the Company.
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. |
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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.
Other Revenue
Other revenue includes quarterly payments received from:
(1) | Bausch & Lomb in connection with the sale of the Silicone Oil product line. This agreement expired August 12, 2005; | ||
(2) | Royalty payments received from Intralase relating to the licensing of the Companys intellectual laser technology; and the settlement payment from Intralase described in footnote 8 of these financial statements in the amount of $9,600,000 | ||
(3) | Royalty payments received from Bio-Rad. |
The following table presents other revenue received by the Company for the years ended June
30, 2008, 2007 and 2006:
2008 | 2007 | 2006 | ||||||||||
Royalty Income: |
||||||||||||
Bio-Rad royalty |
$ | 222,075 | $ | 242,826 | $ | 283,000 | ||||||
Baush and Lomb |
0 | 0 | 203,000 | |||||||||
IntraLase royalty |
0 | 1,102,216 | 1,761,000 | |||||||||
Settlement payment (see note 8) |
0 | 9,600,000 | 0 | |||||||||
Total |
$ | 222,075 | $ | 10,945,042 | $ | 2,247,000 | ||||||
11. Acquisition of MRP and JAS Diagnostics, Inc.
MRP Acquisition
On January 30, 2006 EMI acquired substantially all of the assets of MRP Group, Inc. (MRP) in
exchange for 250,000 shares of the Companys common stock and approximately $47,000 in cash. The
MRP business consists of ophthalmic technology solutions offering two retinal imaging systems.
Approximately 200 of these systems have been installed at leading medical and retinal care centers.
The operating results of MRP are included as part of the Medical/Trek/EMI business unit as of
January 30, 2006.
The Company accounted for the purchase under FAS 141. Under FAS 141, 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 $905,807. 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 values of certain assets and liabilities are
based on preliminary valuations and are subject to adjustment as additional information is
obtained. The Company will have 12 months from the closing of the acquisition to finalize the
valuation. Business unit disclosures and pro forma statement of operations data for 2006 and 2005
do not include MRP operations and assets as they are not material in relation to the consolidated
financial statements.
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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 MRP of January 30, 2006.
Current assets |
$ | 143,569 | ||
Furniture and equipment |
50,000 | |||
Patents and Trademarks |
11,200 | |||
Covenant not to compete |
319,609 | |||
Customer list |
123,360 | |||
Goodwill |
905,807 | |||
Total assets acquired |
1,553,545 | |||
Current liabilities |
78,984 | |||
Net assets acquired |
$ | 1,474,561 | ||
JAS Diagnostics, Inc. Acquisition
On May 29, 2008 Drew acquired the stock of JAS Diagnostics, Inc. (JAS) for $2,100,000 less
assumed liabilities of $127,975. The sales price was payable 33% in cash and 67% (see footnote 5)
in debt from Drew to three of the JAS shareholders, 50% in cash and
50% in debt from Drew to one shareholder 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 unit as of May 30, 2008.
The Company accounted for the purchase under FAS 141. Under FAS 141, 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 values of certain assets and liabilities are
based on preliminary valuations and are subject to adjustment as additional information is
obtained. The Company will have 12 months from the closing of the acquisition to finalize the
valuation. Business unit disclosures for 2007 and pro forma statement of operations data for 2008
and 2007 do not include JAS operations and assets as they are not material in relation to the
consolidated financial statements.
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 | ||
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12. Segment Reporting
The Companys operations are classified into five principal reporting segments for 2008, 2007
and 2006.
Table amounts in thousands:
Segment Statements of Operations (in thousands) Twelve months ended June 30,
Drew | Sonomed | Vascular | ||||||||||||||||||||||||||||||||||
2008 | 2007 | 2006 | 2008 | 2007 | 2006 | 2008 | 2007 | 2006 | ||||||||||||||||||||||||||||
Revenues, net: |
||||||||||||||||||||||||||||||||||||
Product revenue |
$ | 13,332 | 11,627 | 14,253 | $ | 9,367 | 9,823 | 7,737 | $ | 4,119 | 3,467 | 3,640 | ||||||||||||||||||||||||
Other revenue |
$ | 222 | 243 | 283 | $ | 0 | | | $ | 0 | | | ||||||||||||||||||||||||
Total revenue, net |
$ | 13,554 | 11,870 | 14,536 | $ | 9,367 | 9,823 | 7,737 | $ | 4,119 | 3,467 | 3,640 | ||||||||||||||||||||||||
Costs and expenses: |
||||||||||||||||||||||||||||||||||||
Cost of goods sold |
$ | 8,928 | 7,681 | 9,225 | $ | 5,029 | 4,976 | 3,962 | $ | 1,538 | 1,393 | 1,535 | ||||||||||||||||||||||||
Goodwill impairment |
$ | 9,575 | | | $ | 0 | | | $ | 0 | | | ||||||||||||||||||||||||
Operating expenses |
$ | 8,032 | 7,830 | 7,740 | $ | 4,603 | 3,779 | 3,670 | $ | 2,237 | 2,108 | 2,112 | ||||||||||||||||||||||||
Total costs and expenses |
$ | 26,535 | $ | 15,511 | 16,965 | $ | 9,632 | 8,755 | 7,632 | $ | 3,775 | 3,501 | 3,647 | |||||||||||||||||||||||
(Loss) income from
operations |
$ | (12,981 | ) | (3,641 | ) | (2,429 | ) | $ | (265 | ) | 1,068 | 105 | $ | 344 | (34 | ) | (7 | ) | ||||||||||||||||||
Other (expense) and
income: |
||||||||||||||||||||||||||||||||||||
Equity in OTM |
$ | 0 | | | $ | 0 | | | $ | 0 | | | ||||||||||||||||||||||||
Interest income |
$ | 0 | | | $ | 0 | | | $ | 0 | | | ||||||||||||||||||||||||
Interest expense |
$ | (12 | ) | (28 | ) | (63 | ) | $ | 0 | | | $ | 0 | | | |||||||||||||||||||||
Total other (expense) |
$ | (12 | ) | (28 | ) | (63 | ) | $ | 0 | 0 | 0 | $ | 0 | 0 | 0 | |||||||||||||||||||||
(Loss) and income
before taxes |
$ | (12,993 | ) | (3,669 | ) | (2,492 | ) | $ | (265 | ) | 1,068 | 105 | $ | 344 | (34 | ) | (7 | ) | ||||||||||||||||||
Income taxes |
$ | 0 | 0 | 0 | $ | 26 | 37 | 21 | $ | 0 | 1 | 0 | ||||||||||||||||||||||||
Net (loss) income |
$ | (12,993 | ) | (3,669 | ) | (2,492 | ) | $ | (291 | ) | 1,031 | 84 | $ | 344 | (35 | ) | (7 | ) | ||||||||||||||||||
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Segment Statements of Operations (in thousands) Twelve months ended June 30,
EMI | Medical/Trek | Total | ||||||||||||||||||||||||||||||||||
2008 | 2007 | 2006 | 2008 | 2007 | 2006 | 2008 | 2007 | 2006 | ||||||||||||||||||||||||||||
Revenues, net: |
||||||||||||||||||||||||||||||||||||
Product revenue |
$ | 1,762 | 1,484 | 434 | $ | 1,410 | 1,492 | 1,480 | $ | 29,990 | 27,893 | 27,544 | ||||||||||||||||||||||||
Other revenue |
$ | 0 | | | $ | 0 | 10,702 | 1,964 | $ | 222 | 10,945 | 2,247 | ||||||||||||||||||||||||
Total revenue, net |
$ | 1,762 | 1,484 | 434 | $ | 1,410 | 12,194 | 3,444 | $ | 30,210 | 38,838 | 29,791 | ||||||||||||||||||||||||
Costs and expenses: |
||||||||||||||||||||||||||||||||||||
Cost of goods sold |
$ | 820 | 711 | 290 | $ | 995 | 1,011 | 992 | $ | 17,310 | 15,772 | 16,004 | ||||||||||||||||||||||||
Goodwill impairment |
$ | 0 | | | $ | 0 | 0 | 0 | $ | 9,575 | 75 | 1,157 | ||||||||||||||||||||||||
Operating expenses |
$ | 873 | 830 | 635 | $ | 2,705 | 2,722 | 2,668 | $ | 18,450 | 17,269 | 16,825 | ||||||||||||||||||||||||
Total costs and expenses |
$ | 1,693 | 1,541 | 925 | $ | 3,700 | 3,733 | 3,660 | $ | 45,335 | 33,041 | 32,829 | ||||||||||||||||||||||||
(Loss) income from
operations |
$ | 69 | (57 | ) | (491 | ) | $ | (2,290 | ) | 8,461 | (216 | ) | $ | 15,123 | 5,797 | (3,038 | ) | |||||||||||||||||||
Other (expense)income: |
||||||||||||||||||||||||||||||||||||
Gain on sale of available |
$ | 0 | | | $ | 0 | 75 | 1,157 | $ | 0 | 75 | 1,157 | ||||||||||||||||||||||||
Equity in OTM |
$ | 0 | | | $ | (88 | ) | (88 | ) | (174 | ) | $ | (88 | ) | (88 | ) | (174 | ) | ||||||||||||||||||
Interest income |
$ | 0 | | | $ | 299 | 208 | 162 | $ | 299 | 208 | 162 | ||||||||||||||||||||||||
Interest expense |
$ | 0 | | | $ | 0 | | | $ | (12 | ) | (28 | ) | (63 | ) | |||||||||||||||||||||
Total other (expense) and
income |
$ | 0 | 0 | 0 | $ | 211 | 195 | 1,145 | $ | 199 | 167 | 1,082 | ||||||||||||||||||||||||
(Loss) and income before taxes |
$ | 69 | (57 | ) | (491 | ) | $ | (2,079 | ) | 8,656 | 929 | $ | (14,924 | ) | 5,964 | (1,956 | ) | |||||||||||||||||||
Income taxes |
$ | 0 | | | $ | 109 | 14 | 10 | $ | 135 | 52 | 31 | ||||||||||||||||||||||||
Net (loss) income |
$ | 69 | (57 | ) | (491 | ) | $ | (2,188 | ) | 8,642 | 919 | $ | (15,059 | ) | 5,912 | (1,987 | ) | |||||||||||||||||||
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; and (3) vascular
access devices. 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 year ended June 30, 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. Vascular derived its revenue from the sale of PD Access
and SmartNeedle monitors, needles and catheter products and the
VascuView visual ultrasound system. 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, various disposable ophthalmic surgical
products, revenue derived from Bausch & Lombs sale of Silicone Oil (the contract for which expired
on August 12, 2005) and from royalty revenue related to Increases licensing of the Companys
intellectual laser technology. EMI derived its revenue CFA digital imaging systems and related
products.
No customer represented more than 10% of consolidated revenue during the years ended June 30,
2008, 2007 and 2006. Of the external revenue reported above, the following amounts were derived
internationally during the years ended June 30:
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2008 | 2007 | 2006 | ||||||||||
Drew |
$ | 6,587,050 | $ | 5,177,708 | $ | 8,471,608 | ||||||
Sonomed |
5,858,763 | 5,901,532 | 4,316,856 | |||||||||
Vascular |
130,177 | 126,854 | 226,665 | |||||||||
EMI |
53,700 | 8,900 | | |||||||||
Medical/Trek |
31,864 | 40,400 | 29,671 | |||||||||
$ | 12,661,554 | $ | 11,255,394 | $ | 13,044,800 | |||||||
13. 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, 2008, Escalon had invested $357,000 in OTM and owned 45% of OTM. The Company will
provide administrative support functions to OTM. For the years ended 2008, 2007 and 2006 the
Company recorded losses of $88,206, $87,852 and $173,844, respectively.
A relative of a senior executive officer has provided legal services as either an employee or
a consultant to the Company. Caryn Lindsey (daughter-in-law of the CEO) acted as a consultant and
employee for the Company. Ms. Lindsey received consulting fees and salary of $0, $0, and $110,939
and for the years ended June 30, 2008, 2007 and 2006, respectively.
14. Intralase Initial Public Offering and Sale of Intralase Common Stock
In October 1997, the Company licensed its intellectual laser properties to Intralase in
exchange for an equity interest of 252,535 shares of Common Stock (as adjusted for splits), as well
as royalties on future product sales. The Company has historically accounted for these shares a $0
basis because a readily determinable market value was previously not available. On October 7,
2004, Intralase announced the initial public offering of shares of its common stock at a price of
$13.00 per share. The shares of common stock were restricted for a period of less than one year
and were permitted to be sold after April 6, 2005 pursuant to a certain Fourth Amended Registration
Rights Agreement between the Company and Intralase. During 2007, Intralase accepted a $25 per
share tender offer for all its outstanding shares, as such, Escalon received $75,000 for its
remaining holdings in Intralase of 3,000 shares. The Company sold 58,355 shares of Intralase
common stock in July 2005 at $19.8226 per share resulting in gross proceeds of $1,160,316. After
paying broker commissions and other fees of $2,980, the Company received net proceeds of
$1,157,335. The Company sold 191,000 shares of Intralase common stock in May 2005 at $17.9134 per
share resulting in gross proceeds of $3,421,459. After paying broker commissions and other fees of
$9,698, the Company received net proceeds of $3,411,761. During 2007, Intralase accepted a $25 per
share tender offer for all of its outstanding shares.
ITEM 9. | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE |
NONE
ITEM 9A(T). | CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures
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As of the end of the period covered by this Annual Report on
Form 10-K, our management evaluated, with the participation of
our principal executive officer and principal financial
officer, the effectiveness of our 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, our principal executive officer and principal
financial officer concluded that our disclosure controls and
procedures are effective in ensuring that information required
to be disclosed by us 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 Securities and Exchange Commissions rules and
forms and is accumulated and communicated to our management,
including our principal executive officer and principal
financial officer, as appropriate to allow timely decisions
regarding required disclosure.
Managements Report on Internal Control over Financial Reporting
Our 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). Our 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 our assets; | ||
| Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and | ||
| Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our 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, our management evaluated, with the
participation of our principal executive officer and principal
financial officer, the effectiveness of our 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, our management
concluded that our internal control over financial reporting
was effective as of June 30, 2008.
Pursuant to temporary rules of the Securities and Exchange
Commission, our 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 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 our independent registered public accounting firm
regarding our internal control over financial reporting. Our
managements report on internal control over financial
reporting was not subject to attestation by our independent
registered public accounting firm pursuant to temporary rules
of the Securities and Exchange Commission that permit us to
provide only our managements report on internal control over
financial reporting in this Annual Report on Form 10-K.
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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 2008 that would have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
Requirements of Section 404
Under the rules and regulations of the SEC, the Company is currently not required to comply
fully with the requirements of Section 404 of the Sarbanes-Oxley Act of 2002 until the Company
files its Annual Report on Form 10-K for the Companys fiscal year ending June 30, 2010, as long as
the Company continues to meet the definition of a non-accelerated filer. In the Companys Annual
Report on Form 10-K for the year ending June 30, 2008, the Companys management is required to
provide an assessment as to the effectiveness of the Companys internal control over financial
reporting, which assessment is deemed furnished to rather than filed with the SEC. In the Companys
Annual Report on Form 10-K for the year ending June 30, 2009 and for each fiscal year thereafter,
the Companys management will be required to provide an assessment as to the effectiveness of our
internal control over financial reporting and the Companys independent registered public
accounting firm will be required to provide an attestation as to the Companys managements
assessment, which assessment and attestation will be filed with the SEC. The assessment and
attestation processes required by Section 404 are relatively new to the Company. Accordingly, the
Company may encounter problems or delays in completing the Companys obligations and receiving an
unqualified report on the Companys internal control over financial reporting by the Companys
independent registered public accounting firm.
While the Company believes that we will be able to timely meet our obligations under Section
404 and that the Companys management will be able to certify as to the effectiveness of the
Companys
internal control over financial reporting, there is no assurance that we will do so. If the
Company is unable to timely comply with Section 404, the Companys management is unable to certify
as to the effectiveness of the Companys internal control over financial reporting or the Companys
independent registered public accounting firm is unable to attest to that certification, the price
of the Companys common stock may be adversely affected. Even if the Company timely meets the
certification and attestation requirements of Section 404, it is possible that the Companys
independent registered public accounting firm will advise the Company that they have identified
significant deficiencies and/or material weaknesses.
ITEM 9B. | OTHER INFORMATION |
On September 25, 2008 the Board of Directors determined the Goodwill related to the Drew
acquisition was 100% impaired in the amount of $9,574,655 (see Management Discussion and Analysis
and footnote 3 to the consolidated financial statements).
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.
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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 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:
Reports of Independent Registered Public Accounting Firms
Consolidated Balance Sheets as of June 30, 2008 and 2007
Consolidated Statements of Operations for the years ended June 20, 2008, 2007 and 2006
Consolidated Statements of Shareholders Equity for the years ended June 20, 2008, 2007
and 2006
Consolidated Statements of Cash Flows for the years ended June 20, 2008, 2007 and 2006
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.
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(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) | |||
4.1
|
(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) | |||
(c) | Amendment to Warrant Agreement between the Registrant and American Stock Transfer Corporation. (3) | |||
4.2
|
Securities Purchase Agreement, dated as of December 31, 1997 by and among the Registrant and Combination. (4) | |||
4.3
|
Registration Rights Agreement, dated as of December 31, 1997 by and among the Registrant and Combination. (4) | |||
4.4 |
||||
4.5
|
Warrant to Purchase Common Stock issued December 31, 1997 to Trautman, Kramer & Company. (4) | |||
10.1
|
Employment Agreement between the Registrant and Richard J. DePiano dated May 12, 1998. (6)** | |||
10.2
|
Non-Exclusive Distributorship Agreement between Registrant and Scott Medical Products dated October 12, 2000. (9) | |||
10.3
|
Assets Sale and Purchase Agreement between the Registrant and Endologix, Inc. dated January 21, 1999. (5) | |||
10.4
|
Registrants Amendment and Supplement Agreement and Release between the Registrant and Endologix, Inc. dated February 28, 2001. (10) | |||
10.5
|
2003 Amendment to Loan Agreement. (12) | |||
10.6
|
Allonge to the Amended and Restated Term/Time Note. (12) | |||
10.7
|
Allonge to the Amended and Restated Line of Credit Note. (12) | |||
10.8
|
Registrants amended and restated 1999 Equity Incentive Plan. (13) ** | |||
10.9
|
Securities Purchase Agreement dated as of March 16, 2004 (the Securities Purchase Agreement) between the Company and the Purchasers signatory thereto. (14) | |||
10.10
|
Registration Rights Agreement dated as of March 16, 2004 between the Company and the Purchasers signatory thereto. (14) | |||
10.11
|
Form of Warrant to Purchase Common Stock issued to each Purchaser under the Securities Purchase Agreement. (14) | |||
10.12
|
Manufacturing Supply and Distribution Agreement between Sonomed, Inc. and Ophthalmic Technologies, Inc. dated as of March 11, 2004. (15) | |||
10.13
|
Supplemental Executive Retirement Benefit Agreement for Richard DePiano dated June 23, 2005. (16)** | |||
10.14
|
Settlement Agreement with Intralase Corp, dated February 27, 2007. (17) | |||
10.15
|
Securities Purchase Agreement dated as of May 29, 2008 (the Securities Purchase Agreement) between the Company and the Purchasers signatory thereto. (*) | |||
21
|
Subsidiaries. (11) | |||
23.1
|
Consent of Independent Registered Public Accounting Firm (*). |
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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 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. | |
(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-8 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 10-K dated September 28, 2007. |
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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: September 29, 2008
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 | September 29, 2008 | ||||||
Richard J. DePiano | Officer (Principal Executive | |||||||||
Officer) and Director | ||||||||||
By: |
/s/ | Robert M. OConnor | Chief Financial Officer | September 29, 2008 | ||||||
Robert M. OConnor | (Principal Financial Officer) | |||||||||
By: |
/s/ | Anthony Coppola | Director | September 29, 2008 | ||||||
Anthony Coppola | ||||||||||
By: |
/s/ | Jay L. Federman | Director | September 29, 2008 | ||||||
Jay L. Federman | ||||||||||
By: |
/s/ | William L.G. Kwan | Director | September 29, 2008 | ||||||
William L.G. Kwan | ||||||||||
By: |
/s/ | Lisa Napolitano | Director | September 29, 2008 | ||||||
Lisa Napolitano | ||||||||||
By: |
/s/ | Fred Choate | Director | September 29, 2008 | ||||||
Fred Choate |
74