Medical Action Industries 10-K 2007
Documents found in this filing:
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
For the Fiscal Year ended March 31, 2007
For the transition period to
Commission File No. 0-13251
MEDICAL ACTION INDUSTRIES INC.
(Exact name of registrant as specified in its charter)
Registrants telephone number, including area code: (631) 231-4600
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act: Common Stock, $.001 par value
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ¨ No x
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No x
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 x No ¨
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K 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 x.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in Rule 12-b of the Exchange Act. (Check one):
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
The aggregate market value of the registrants Common Stock held by nonaffiliates of the registrant as of June 7, 2007 was approximately $300,000,000. As of June 7, 2007, registrant had outstanding approximately 15,863,411 shares of Common Stock.
Parts of the following documents are incorporated by reference to Parts I, II, III and IV of this Form 10-K Report: (1) Proxy Statement for registrants 2007 Annual Meeting of Stockholders and (2) registrants Annual Report to Stockholders for the fiscal year ended March 31, 2007.
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
This Report includes Forward-Looking Statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are Forward-Looking Statements for purposes of these provisions, including any projections of earnings, revenues or other financial items, any statements of the plans and objectives of management for future operations, any statements concerning proposed new products or services, any statements regarding future economic conditions or performance, and any statements of assumptions underlying any of the foregoing. All Forward-Looking Statements included in this document are made as of the date hereof and are based on information available to the Company as of such date. The Company assumes no obligation to update any Forward-Looking Statement for any reason, except as required by law. In some cases, Forward Looking Statements can be identified by the use of terminology such as may, will, expects, plans, anticipates, intends or believes, estimates, potential, or continue, or the negative thereof or other comparable terminology. Although the Company believes that the expectations reflected in the Forward-Looking Statements contained herein are reasonable, there can be no assurance that such expectations or any of the Forward-Looking Statements will prove to be correct, and actual results could differ materially from those projected or assumed in the Forward-Looking Statements. Factors that might cause such differences include, but are not limited to, those discussed in the subsection entitled Factors That May Affect Future Results and Financial Condition under Part One of this Report. All subsequent Forward-Looking Statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements.
ITEM 1 BUSINESS
Medical Action Industries Inc. (Medical Action or the Company) was incorporated under the laws of the State of New York on April 1, 1977, and re-incorporated under the laws of the State of Delaware on November 5, 1987. Headquartered in Hauppauge, New York, Medical Action develops, manufactures, markets and supplies a variety of disposable medical products. The Companys products are marketed primarily to acute care facilities in domestic and certain international markets, and in recent years has expanded its end-user markets to include physician, dental and veterinary offices, out-patient surgery centers and long-term care facilities. Medical Action is a leading manufacturer and supplier of patient bedside utensils, collection systems for the containment of medical waste, minor
procedure kits and trays, sterile disposable operating room towels and sterile disposable laparotomy sponges. The Companys products are marketed by its direct sales personnel and extensive network of distributors. Medical Action has entered into preferred vendor agreements with national distributors, as well as sole source and/or committed contracts with group purchasing alliances. The Company also manufactures its products under private label programs to other distributors and medical suppliers. Medical Actions manufacturing, packaging and warehousing activities are conducted in its Arden, North Carolina, Gallaway, Tennessee, Clarksburg, West Virginia and Northglenn, Colorado facilities. The Companys procurement of certain products and raw materials from the Peoples Republic of China is administered by its office in Shanghai, China.
The Companys strategy is to focus its resources on entering new markets for its existing product lines, including alternate care, physician, veterinary and dental markets; accelerate the internal development of new products for its existing markets and pursuit of acquisitions which include products that complement existing product lines for utilization of the Companys extensive sales and distribution channels; the introduction of its products into the international marketplace; and to increase productivity by maximizing the utilization of its existing facilities.
Since 1994, the Company has engaged in an active acquisition program completing ten transactions. These transactions include:
The Companys products are divided into six (6) categories:
Within each of these categories are multiple product lines that have either been internally developed or acquired, as set forth below:
The following paragraphs contain a brief description of, and provide other information regarding, Medical Actions key products:
Patient Bedside Utensils
Wash Basins used in both hospital in-patient setting, as well as in nursing homes and other long term convalescent care applications, polypropylene wash basins come in a range of sizes and colors. They are available in disposable, plastic single patient reusable, and stainless steel fully-reusable designs.
Bedpans for immobile patients bedpans come in conventional, over the commode seat, stackable and pontoon styles. Polypropylene bedpans come in a range of sizes and colors and are available in disposable, plastic single patient reusable, and stainless steel fully-reusable designs.
Pitchers & Carafes are available in reusable and disposable configurations. Pitchers and carafes are injection molded from durable polypropylene and include options such as ice guards, cup covers, hinged lids, and graduations. Liner and jacket sets are sold separately and provide for additional insulation and quick replenishment.
Urinals for immobile patients urinals are made in a variety of designs. Differing versions accommodate male and female anatomy, and are made from opaque blue or translucent clear polypropylene which facilitates measuring and visualizing contents. Urinals are graduated in 25 cc and 1 oz. increments up to 1,000 ccs.
Emesis Basins are available in reusable and disposable configurations and are graduated in 100 cc increments. Emesis basins are used for containing fluids, measuring output and routine oral care.
Minor Procedure Kits and Trays
The Company offers kits and trays which are used for a wide variety of minor surgical and medical procedures. Kit components are determined by the procedural requirements and may be customized to accommodate individual hospital protocols and preferences. Procedural applications and typical components for the Companys larger kits segments are as follows:
I.V. Start Kits One of the most common medical procedures is intravenous administration of fluids and medications usually done through an I.V. catheter or needle which is inserted into a peripheral vein. Since infection at the site of the catheter insertion can become systemic and potentially serious, I.V. start kits are used to insure speed and efficiency of catheter insertion while promoting sound clinical protocol. Typical components include a tourniquet, antiseptic ampule or swab, gauze, alcohol prep pads and a dressing. The Companys I.V. start kits are
marketed under the ActaSept and Cepti-Seal® brands. For the fiscal year ended March 31, 2007, 2006 and 2005, I.V. Start Kits accounted for 13%, 15% and 12%, respectively, of the Companys total sales.
Central Line Dressing Trays Central line dressing trays are used to provide for cleansing and dressing placement at the site of a central venous catheter which is typically placed in a vein in the patients chest area and is used for the rapid infusion of fluids and medications. Since infection at the site of catheter insertion can become systemic and represents a potentially serious medical complication, central line dressing kits facilitate fast and efficient dressing changes while allowing the clinician to maintain sterile technique. Typical components include an antiseptic ampule or swabs, gloves, gauze tape and a transparent dressing. The Companys Central Line Dressing Trays are marketed under the ActaSept and Cepti-Seal® brands.
Suture Removal Trays Post procedural suture removal is a medical procedure commonly performed in physicians offices, outpatient settings, and hospital emergency rooms among other acute and alternate care settings. The procedure requires precise instruments for grasping and cutting fine sutures. Typical suture removal tray components include Littauer scissors, alcohol prep pads, metal or plastic forceps and the Companys proprietary ACU-dyne povidone iodine anti-microbial solution.
Laceration Trays Laceration trays are used to facilitate closure of lacerations and other deep wounds. Use is primarily concentrated in hospital emergency rooms although they are sold in both acute and alternate care settings wherever emergency care is provided. Typical components are high quality disposable instruments including needle drivers, forceps, scissors and hemostats, as well as drapes for creation of a sterile field, gauze and syringes and needles for administration of a local anesthetic.
Instruments and Instrument Trays The Company offers a broad array of high quality disposable needle holders, hemostats, various procedural scissors, scalpels and forceps. These instruments are available in stainless steel, bent wire, and plastic versions. They can be purchased in bulk, packaged sterile as individual instruments, or combined in custom sterile instrument trays.
Containment Systems for Medical Waste
Biohazardous Waste Containment and Autoclave Bags Various state and federal regulations require that infectious medical waste be collected, stored, transported and disposed of in specially designed and specifically labeled containers. The Companys infectious waste collection bags, known as biohazard bags or red bags, are constructed from high
quality resins with reinforced seals for puncture resistance to reduce the risk of leakage. The bags come in a variety of sizes, and are red, and are clearly labeled with the international biohazard symbol. Autoclave bags are designed to survive the heat generated in a steam autoclave and are used to contain infectious waste through steam sterilization and disposal.
Non-Infectious Medical Waste Containment Bags Non-infectious medical waste and trash must be collected, stored, transported and disposed of in a separate waste stream from potentially infectious or biohazardous waste. The Companys non-infectious medical waste bags come in a variety of sizes, materials, mil thicknesses and seal configurations to isolate the range of non-infectious medical waste generated at healthcare provider sites from collection to disposal.
Chemotherapy Waste Containment Bags and Sharps Containers Waste contaminated with chemotherapeutic agents must be disposed of in a separate waste stream from normal infectious and non-infectious medical waste due to the toxic nature of many of these agents. The Companys chemotherapy waste containment bags and sharps containers are made of special resins for the collection and containment of chemo waste through disposal.
Laundry and Linen Containment Systems and Disposable Bags Infectious and non-infectious reusable laundry and linen must be collected in specifically designed and clearly labeled receptacles and be segregated from the infectious and non-infectious medical waste streams. The Company offers laundry and linen containment systems consisting of hamper style receptacles and disposable laundry and linen receptacle bags for the collection, storage and transportation of infectious and non-infectious laundry and linen.
Laboratory Specimen Transport Bags Used to collect, transport and contain tissue samples and other patient specimens obtained from examinations, diagnostic, or surgical procedures. The bags feature a specimen compartment and documentation pouch to insure that specimens and paperwork do not become separated during transport.
Patient Belonging Bags used to collect, contain and transport patient belongings from admission to discharge. The bags come in a variety of sizes, and thicknesses, and utilize a combination of handle, drawstring closure, and zip closure designs. These bags are often customized with hospital or healthcare facility logos and designs.
Sharps Containment Systems various state and federal regulations require that certain infectious medical waste, such as needles and blades, be collected, contained, transported and disposed of in rigid containers. The Companys sharps containers come in variety of sizes and configurations and are constructed from high quality resins protecting the
public and healthcare workers from accidental stick injuries and potential transmission of pathogens in blood and body fluids. These containers are designed to be puncture resistant and to have torturous path means of egress once a contaminated device is placed inside.
Equipment Dust Covers are used to for the protection of hospital equipment which is non-sterile. They provide a dust and dirt barrier for equipment that is stored between procedures.
Operating Room Disposables and Sterilization Products
Disposable Operating Room Towels The Companys line of absorbent cotton operating room towels are used during surgery for drying hands, rolled up for propping instruments, on back tables and mayo stands for absorbing fluids, around the incision site for absorbing blood and to allow the surgeon to clip tubing and instruments close to the surgical site during the surgical procedure. Operating room towels are sold in sterile packaging for single use and as a non-sterile component to be used with other health care companies products, primarily surgical pre-packaged procedure trays. For the fiscal years ended March 31, 2007, 2006, and 2005, operating room towels accounted for, 11%, 15% and 16%, respectively, of the Companys total net sales.
Surgical Marking Pens Used for marking the patients skin prior to making a surgical incision. Specifically designed so that the pen barrel fits comfortably in the surgeons hand and is made with gentian violet color ink. All pen barrels are embossed with a 5 cm. ruler and may also include a 15 cm. coated ruler and blank labels.
Needle Counters Red plastic boxes manufactured from medical grade materials designed to resist breakage and punctures. They are produced with a variety of designs, including surgical grade magnets in order to facilitate sharps disposal, foam blocks and foam strips with varying count capacity and designs.
Disposable Surgical Light Handle Covers Light ShieldsTM A patented design assures a secure fit and acts as a sterile barrier on surgical light handles in the operating room. Light ShieldsTM are manufactured of a heavy gauge flexible plastic for the optimum assurance of a sterile barrier.
Convenience Kits The Company offers its customers the ability to purchase multiple products packaged with its needle counters. The Company has the flexibility to package many different kits to individualize a hospitals requirements.
Surgical Headwear and Shoe Covers Worn by operating room and other critical care personnel these items prevent contamination of sterile and clean environments from dust and other gross contaminants as well as
protection of healthcare worker apparel. Bouffant caps made of lightweight spunbond polypropylene and surgeons caps made of kaycel are comfortable and absorbent. Shoe covers are made of durable polypropylene and are available with a skid resistant coating.
Isolation Gowns The Companys line of disposable isolation gowns are used to prevent contamination of health care worker apparel during a variety of medical procedures. They are available in yellow fluid resistant spunbond cloth and impervious poly coated spunbond configurations.
Sterilization Pouches Used to house instruments during the sterilization process and maintain sterility of the instrument until it is needed. The pouches are primarily used in hospital central supply, operating rooms and in physicians and dentists offices as well as in any environment where sterile instruments are needed. There are three different styles of pouches availableself seal, heat seal and rolls. The self seal is already sealed on three sides and includes a peel back adhesive strip on the bottom of the package, which when folded over will seal the package. The second type is heat seal, which is also sealed on three sides but needs a heat sealer to seal the fourth side. The Company also markets a roll product, where the user can pull as long a pouch as needed and then seal each end of the pouch.
Sterilization Monitoring Products These are printed paper and chemical devices used to measure certain necessary parameters within a sterilization cycle. Predominate users include the hospital operating room which often houses steam sterilization units for unanticipated needs while cases are in progress, and the central sterile department which cleans, packages and sterilizes the bulk of reusable surgical supplies.
Prior to sterilization, indicators and integrators are placed inside of the packaged products and sterilization pouches which are then distributed and used throughout the hospital, clinic or physician office environment.
Crutches Lightweight aluminum adjustable patient crutches complete with tips and pads. Push-button adjustable foot piece for fast, precise measuring and fitting. Offered in a full range of sizes child, youth, adult, and tall adult. Used to assist mobility in the event of a leg, foot, or ankle injury.
Walkers Lightweight, high strength aluminum patient walkers. Contoured PVC handgrips for comfort and rubber tips for traction. They are available in a 1-button and 2-button version that facilitates folding of the walkers for easy storage and transport. Used to assist patient mobility for both the short and long term.
Canes Lightweight, high strength aluminum patient canes that are fully height adjustable from 30 to 39 in 1 increments. PVC handgrip for comfort and non-slip rubber tip for stability. Used to assist patient mobility for both the short and long term.
Patient Slippers Skid resistant patient slippers available in a full range of sizes from infant, toddler, youth, to adult (from small to XXL). Color coded by size. Used to prevent slipping and to provide warmth and comfort in both acute care and long-term care market settings.
Dressings and Surgical Sponges
Burn Dressings The Company provides dry burn dressings and non-adherent gauze burn dressings. The dry burn dressings are composed of multiple layers of folded gauze that are typically customized for individual hospitals as to size, weave, folds, and stitching. The non-adherent dressings reduce sticking and skin removal during dressing changes, thereby alleviating trauma and pain to the wound site.
Disposable Laparotomy Sponges Laparotomy sponges are designed primarily for use during surgical procedures in hospitals and health facilities. They are single use and made of gauze and sold in varying sizes and utilized for a multitude of purposes. Laparotomy sponges cover exposed internal organs, isolating them from the part of the body being operated upon. They also absorb blood and act as a buffer between medical instruments and the skin, thereby reducing trauma to the skin tissue caused by the medical instrument. Laparatomy sponges are sold in sterile packaging or as a non-sterile component to be used with other health care companies products, primarily surgical pre-packaged procedure trays. The Companys laparotomy sponges contain an x-ray detectable element and loop handle in order to facilitate easy counting and identification in the operating room. For the fiscal years ended March 31, 2007, 2006, and 2005, laparotomy sponges accounted for 6%, 9%, and 9%
respectively, of the Companys total net sales.
Specialty Surgical Sponges The Companys line of specialty surgical sponges is an extension to its laparotomy sponge product line. They are single use and made of gauze and sold in varying sizes and shapes. The design of these sponges is tailored to specific surgical applications for which a standard laparotomy sponge is sub-optimal. There are two classifications of specialty surgical sponges:
a) Specialty Sponges for Open Surgical Procedures including Peanut, Kittner, and Cherry dissecting sponges, used for blunt tissue dissection and fluid absorption, Tonsil Sponges with abdominal tape strings for easy retrieval from narrow body cavities, Stick Sponges used for surgical prepping and fluid absorption in deeper body cavities, and Eye Spears for absorption during eye surgery.
(b) Endoscopic Specialty Sponges including Kittner, Cherry, and Bullet style dissecting sponges. Endoscopic specialty sponges are small sponges affixed to long fiberglass rods and are designed for performing blunt tissue dissection, fluid absorption, and anatomical manipulation through the narrow operating cannulae used in minimally invasive endoscopic surgery.
Gauze Sponges Gauze sponges are used in the operating room as well as throughout the hospital. They are also used extensively throughout the alternate care market, including physicians offices, health clinics, and dentists offices and in veterinary practices. The Company also introduced gauze fluffs, which are pre-folded gauze sponges used for compression and absorption of blood and other fluids.
Sponge Counting System The Companys line of sponge counter bags is designed to facilitate and improve the post-procedural counting of surgical sponges. Peri-operative nursing protocol calls for a systematic count of used and unused sponges and instruments pre and post surgically to insure that foreign bodies are not left in the body cavity. The Companys Pocket Count and patented SAFE-T-Count are clear faced opaque backed plastic bags with up to 10 sponge compartments. The compartments act as fluid receptacles while providing visualization of used sponges for fast and accurate post surgical counting.
Net, Padding and Wound Care Includes proprietary Tubegauz® premium brand and SePro® value brand elastic nets, which are tubular bandages used for dressing retention. This category also includes Tubegauz® brand tubular gauze, which is used to bandage fingers, toes, hands, or other areas that require wrapping to bodily contours. Padding products are used as a protective cushioning material for sensitive areas,
and are sold in styles that offer unique characteristics such as being mold-resistant, water-repellant or designs for improved air circulation.
Petri Dishes used in the laboratory Petri dishes are used to culture microorganisms. Economical, optically clear dishes are precision molded from polystyrene to maintain optical quality and controlled flat surfaces so cultures are clearly visible without distortion.
Specimen Containers used for the collection and transportation of fluid and tissue samples. Polypropylene specimen Containers are available in several sizes and styles including screw top, snap cap, and the patented ClikSeal for insuring sample security and leak resistance during transport. A sterility seal and patient i.d. label with lines for number, name, and doctor are typical features of specimen containers.
Commode Specimen Collectors used for the collection of and measurement of waste. Injection molded LDPE commode collectors fit securely on standard toilets and allow for easy collection and quick visualization, measurement and disposal. Other versions can be sealed for transportation to the laboratory for analysis.
Triangular Graduates used for measuring intake or output, triangular graduates are made from either clear polystyrene or translucent polypropylene. The containers are graduated in 25cc and .5 ounce increments, up to 1000 ccs and 32 ounces. The triangular style provides measuring ease, visualization of contents and comfortable handling.
Tri-pour Beakers used in hospitals, clinics, laboratories and nursing homes for accurate drip-free mixing and or pouring of liquids. Tri-pour beakers are made from translucent polypropylene and are resistant to commonly used acids, alkalis, solvents and reagents and are autoclaveable. They range sizes from 50ml to 1000ml, and each beaker is graduated in increments of 10, 20 or 50ml.
Patents and Trademarks
The Company actively pursues a policy of seeking patent protection, both in the United States and abroad, for its proprietary technology. There can be no assurance that the Companys patents will not be violated or that any issued patents will provide protection that has commercial significance. Litigation may be necessary to protect the Companys patent position. Such litigation may be costly and time-consuming, and there can be no assurance that the Company will be successful in such litigation. Since no single patent covers product lines that constitute 5% or more of any sales of the Company for fiscal 2007, the Company does not believe that any violation of any patents owned by the Company would have a material adverse effect on
it or its business prospects.
The Company owns several patents and trademarks. While it considers that in the aggregate the patents and trademarks are important in the operation of its business, it does not consider that any of them, or any group of them, are of such importance that termination would materially affect its business.
Although there is no assurance that other companies will not be successful in developing similar products without violating the rights of the Company, management does not believe that the invalidation of any patents owned by the Company would have a material adverse effect on it or its business prospects. While the protection of patents is important to the Companys business, management does not believe any one patent is essential to the success of the Company.
The Company also relies on trade secrets and product advancement to maintain its competitive position. There can be no assurance that the Company will prevent the unauthorized disclosure or use of its trade secrets and know-how or that others may not independently develop similar trade secrets or know-how or obtain access to the Companys trade secrets, know-how or proprietary technology.
Group Purchasing Agreements
Hospital chains and large buying groups have played, and are expected to continue to play, an increasingly significant role in the purchase of medical devices. In recent years these group purchasing organizations (GPO) have sought to narrow their list of suppliers. By acting as a supplier to a GPO the Company can operate its sales force much more efficiently. As a result, the Companys sales force continues to call on facilities associated with these buying groups in order to improve compliance with these group purchasing agreements and improve market share. These agreements, which typically have no minimum purchase requirements, can be terminated on ninety (90) days advance notice. The termination or non-renewal of any of the agreements could have a material adverse effect on the Companys business.
The markets in the Companys product lines are highly competitive. In general, the Companys products compete with the products of numerous major companies in the business of developing, manufacturing, distributing and marketing medical products. Some of these competitors have greater financial or other resources than the Company. The Company believes that the principal competitive factors in each of its markets are (i) product design, development and improvement, (ii) customer support; (iii) brand loyalty; and (iv) price. The Company emphasizes overall value through a
combination of competitive pricing, product quality and customer service.
The competitors differ based upon the products being sold. In the sale of sterile laparotomy sponges, where Cardinal Health, Inc., the Kendall Company, a subsidiary of Tyco Industries, Inc. and Medline Industries, Inc. are competitors, Medical Actions sales represent a significant share of the domestic market. The Companys primary competitors in the sale of sterile operating room towels, in which the Company is also a leading supplier in the domestic market, are Cardinal Health, Inc., Medline Industries, Inc. and DeRoyal, Inc. Management believes that the breadth of its line of collection systems for the containment of medical waste is the most complete in the industry, where it competes with Cardinal Health, Inc., Donovan, Inc. and Heritage Bag Company. In the sale of minor procedure kits and trays where the Company has a significant market share, the Companys primary competitors include Cardinal Health, Inc., Becton, Dickinson and Company and the Kendall Company, a subsidiary of Tyco Industries, Inc. In the sale of medical pouches to the hospital market, where the Company is one of the leading suppliers, the Companys primary competitors include Cardinal Health, Inc. In the sale of operating room accessories, where the Companys portion of the market is relatively insignificant, the Companys primary competitor is Devon Industries, Inc., a subsidiary of Tyco Industries, Inc. In the sale of patient bedside utensils, where Cardinal Health, Inc., and Medline Industries, Inc. are competitors, Medical Actions sales represent a significant share of the domestic market. In the sale of laboratory products, where Cardinal Health, Inc., Tyco Industries, Inc., Becton, Dickinson and Company, Kord Products Inc., and Parter Medical Products, Inc., are competitors, Medical Actions sales represent a significant share of the domestic market.
In recent years, several comprehensive healthcare reform proposals were introduced in the U.S. Congress. The intent of the proposals was, generally, to expand healthcare coverage for the uninsured and reduce the growth of total healthcare expenditures. While none of the proposals were adopted, healthcare reform may again be addressed by the current U.S. Congress. While the Company cannot predict whether any healthcare reform legislation will be approved or what effect, if any, that such healthcare reform legislation will have on the Company or its operations, the Company believes that based on the intent of such proposals, healthcare legislation may have some beneficial effects on its business by increasing the availability of healthcare.
As a manufacturer of medical devices, the Company is subject to regulation by, among other governmental entities, the U.S. Food and Drug Administration (FDA) and the corresponding agencies of the states and foreign countries in which the Company sells its products. These
regulations govern the introduction of new medical devices, the observance of certain standards with respect to the manufacture, testing and labeling of such devices, the maintenance of certain records, the tracking of devices and other matters. All medical devices are required to be registered with the FDA. The Company must update its establishment and listing information on an annual basis.
Pursuant to the Food, Drug and Cosmetic Act (FDC Act), medical devices intended for human use are classified into three categories, Classes I, II and III, on the basis of the controls deemed necessary by the FDA to reasonably assure their safety and effectiveness. Class I devices are subject to general controls (for example, labeling, premarket notification and adherence to good manufacturing practice regulations) and Class II devices are subject to general and special controls (for example, performance standards, post-market surveillance, patient registries and FDA guidelines). Generally, Class III devices are those which must receive premarket approval (PMA) from the FDA to ensure their safety and effectiveness (for example, life-sustaining, life-supporting and implantable devices, or new devices which have not been found substantially equivalent to legally marketed devices), Class I devices, unless exempt, and Class II devices require premarket notification clearance pursuant to Section 510(k) of the FDC Act. Class III devices are required to have a PMA. A 510(k) premarket notification clearance indicates that the FDA agrees with an applicants determination that the product for which clearance has been sought is substantially equivalent to another medical device that has been previously marketed. To date, all of the Companys products have received 510(k) clearances or are exempt from the 510(k) clearance process.
In addition to requiring clearance or approval for new products, the FDA may require clearance or approval prior to marketing products that are modifications of existing products. The FDC Act provides that new 510(k) clearances are required when, among other things, there is a major change or modification in the intended use of the device or a change or modification to a legally marketed device that could significantly affect its safety or effectiveness. A manufacturer is expected to make the initial determination as to whether a proposed change to a cleared device or to its intended use is of a kind that would necessitate the filing of a new 510(k) notification.
The Company is also required to register with the FDA as a device manufacturer and to comply with the FDAs Good Manufacturing Practices under the Quality System Regulations (GMP/QSR). These regulations require that the Company manufacture its products and maintain its records in a prescribed manner with respect to manufacturing, testing and control activities. The Companys manufacturing, quality control and quality assurance procedures and documents are inspected and evaluated periodically by the FDA.
The European Union has promulgated rules, under the Medical
Devices Directive, or MDD, which require medical devices to bear the CE mark. The CE mark is an international symbol of adherence to quality assurance standards. The Company received EN ISO 13485:2003 certification for its Arden, North Carolina manufacturing facility and has instituted all the systems necessary to meet the Medical Device Directive, thus acquiring the ability to affix the CE mark to certain products.
Sales, Marketing and Customers
The Companys products are presently marketed and sold primarily to acute care facilities throughout the United States through a network of direct sales personnel. In addition, the Company has expanded its target markets to include physician, dental and veterinary offices, out-patient surgery centers and long-term care facilities.
The Companys sales representatives typically attempt to establish and maintain direct contact with medical professionals that directly utilize the Companys products. As medical product purchases are typically made on a centralized basis by hospital purchasing departments, and increasingly by healthcare networks, sales representatives must also maintain relationships with purchasing department personnel. The Company has approximately fifty-four (54) direct sales personnel throughout the United States engaged in the sales and marketing of the Companys products.
In addition to the field sales personnel focused on the United States acute care market, Medical Action has senior sales and marketing professionals focused on group purchasing organizations, government sales, large integrated delivery networks and with national and regional distributors.
The Companys distribution network is comprised of hospital distributors, alternate care distributors, physician distributors, veterinary distributors, dental distributors and industrial safety distributors covering the entire United States and certain international marketplaces. The Companys products are typically purchased pursuant to purchase orders or supply agreements in which the purchaser specifies whether such products are to be supplied through a distributor or directly by the Company. The Company records sales upon the shipment of inventory to the distributor, at which time title passes to the distributor.
No individual customer or affiliated group of customer accounts accounted for more than 10% of the Companys net sales in any of the past three fiscal years. Nevertheless, sales to Owens & Minor, Inc., Cardinal Health Inc. and McKesson Corporation, diversified distribution companies (the Distributors) accounted for approximately 37%, 22% and 2% respectively, for the fiscal year ended March 31, 2007, 33%, 19% and 9%, respectively, for the fiscal year ended March 31, 2006, and 33%, 18% and 9%, respectively, for the fiscal year ended March 31, 2005. In fiscal 2007, Owens
& Minor, Inc. acquired the acute care distribution business of McKesson Corporation. Although the Distributors may be deemed in a technical sense to be major purchasers of the Companys products, the Distributors typically serve as a distributor under a purchase order or supply agreement between the customer and the Company, and does not purchase for its own account. The Company, therefore, does not believe it is appropriate to categorize the Distributors as actual customers.
Management believes that the continuing pressure to utilize low-cost, disposable medical products has significantly expanded the use of custom procedure trays, which contain the necessary items designed for use in specific procedures by surgical teams. Many of the custom tray suppliers are vertically integrating the packaging process by buying bulk, non-sterile operating room towels, laparotomy sponges and other products manufactured by the Company to place in these custom trays. The trays are then sterilized, saving valuable nursing time and the costs associated with individual product packaging.
The Company believes it has established an efficient system for marketing its products throughout the United States, and intends to utilize these existing sales methods and channels to market new products as they are developed or acquired.
In addition to branded sales to the United States healthcare market, the Company generates revenue to OEM customers in the healthcare, laboratory and non-medical markets. Moreover, Medical Action provides and sells products to international markets via independent in country distribution networks, supported by operations in the United States, Brazil and China.
Research and Development
The Company is continually conducting research and developing new products utilizing a team approach that involves its engineering, manufacturing and marketing resources. Although the Company has developed a number of its own products, most of its research and development efforts have historically been directed towards product improvement and enhancements of previously developed or acquired products. Product development expenses were approximately $788,000, $599,000 and $429,000 for the fiscal years ended March 31, 2007, 2006, and 2005, respectively.
As of June 1, 2007, the Company had approximately 703 full-time employees with 475 in manufacturing and distribution, 78 in marketing and sales, and 150 in administration. Except for 148 employees in the Companys Gallaway, Tennessee facility, which are represented by the
Service Employees International Union (SEIU), none of the Companys employees are represented by a labor union. The Company has entered into an agreement with the SEIU for the three (3) year period ending February 2010. The Company believes that its employee relations are satisfactory.
The Company does not believe that its backlog figures are necessarily indicative of its business since most hospitals and health related facilities order their products on a continuous basis and not pursuant to any contractual arrangements. Since typical shipment times range from two to five days, the Company must maintain sufficient inventories of all products at all times.
Raw Materials and Manufacturing
The principal raw materials used by the Company are a four-ply mesh gauze laparotomy sponge, cotton huck towel and various types of plastic resin. Other materials and supplies used by the Company include gauze, gauze sponges, injection molded and thermoformed plastics, medical instruments, various types of antiseptics and wound dressings, aluminum, foam, medical grade magnets and a variety of packaging material. Several of these raw materials are supplied from vendors outside the United States.
Medical Actions variety of suppliers for raw materials and components necessary for the manufacture of its products, as well as its long term relationships with such suppliers, help to ensure the stability in its manufacturing process. Historically, Medical Action has not been materially affected by interruptions with such suppliers. However, if a supplier of significant raw materials, component parts, finished goods or services were to terminate its relationship with the Company, or otherwise cease supplying raw materials, component parts, finished goods or services consistent with past practices, the Companys ability to meet its obligations to its customers may be disrupted. A disruption with respect to numerous products, or with respect to a few significant products, could have a material adverse effect on the Companys business and financial condition. During the past few years, world events have caused the cost of oil and natural gas prices to increase to historical new heights, causing the cost of resin, the principal raw material in the manufacture of our plastic products, to unprecedented levels.
The Company presently purchases its principal cotton raw materials primarily from the Peoples Republic of China and to a lesser extent, India and is currently sourcing instruments from Pakistan, a portion of its thermoform plastics from Taiwan, packaging material from the United Kingdom and needle counters from the Peoples Republic of China. From time to time, the Company has purchased certain of its raw materials from a number of other countries including Mexico and the Dominican Republic. Some of the Companys products are purchased as components or in final
form, which are shipped to the Companys manufacturing facility in Arden, North Carolina, where they are packaged. The Companys sterilization pouches and minor procedure kits and trays are predominantly manufactured and/or assembled in the Companys Arden, North Carolina manufacturing facility. The Company utilizes outside contract sterilization facilities for its products.
In the Companys Clarksburg, West Virginia facility, where the Company manufactures its containment systems for medical waste, three (3) types of plastic resin are utilized in the various processes; (i) linear low density polyethylene; (ii) high density polyethylene; (iii) film extrusion polypropylene.
In the manufacture of collection systems, resin is extruded through the die where it emerges in a gelatinous state. The extruder and die are positioned under a cooling tower where the emerging plastic is pressed closed and air is blown into it creating a cylindrical column. The column is then pulled up the tower and back down over conveying rollers, and is threaded through a printer, bag machine, triangle folder, separator and air folder into an individually folded bag.
The Companys sharps containers, currently manufactured by a third-party, are also manufactured from either polypropylene or polyethylene resin and are produced either by extrusion blow-molding or by high pressure injection molding. In extrusion blow molding, the resin is melted by friction and applied heat in a long tube with a precisely flighted revolving auger, delivering the molten plastic through an extruder die to form a hollow tube. As the tube exits the extruder, a 2-part blow mold whose internal cavity is in the shape of the finished product, closes around the tube and high pressure are is introduced to form the finished product. In injection molding, a similar barrel and screw auger system plasticizes the resin before injecting the molten plastic into 2-part precision molds. These molds are closed under very high pressure, forcing the plastic to fill all of the voids in the mold and taking the shape of the finished part, then rapidly cooled with water running through the mold structure before being ejected for packaging. During fiscal 2008, the injection molded style will be manufactured internally at the Companys Gallaway, Tennessee facility.
Our Gallaway, Tennessee facility primarily manufactures and/or distributes disposable plastic patient utensils, primarily used in hospital admission kits, as well as other collection, measuring and containment products. These products are manufactured with homopolymer and copolymer polypropylene, high density polyethylene and linear low density polyethylene, primarily utilizing either injection molded plastic process or extrusion blow molding. In addition, the Gallaway facility purchases contract manufactured or private labeled finished products for distribution to its customers. These products include stainless and reusable plastic containers and utensils manufactured domestically, as well as various
measuring and collection products procured from the Peoples Republic of China.
The Companys Northglenn, Colorado facility produces plastic disposable laboratory and OR products including Petri dishes, bowls, culture tubes and specimen containers, as well as supporting the Tennessee facility with patient utensils. These are also manufactured utilizing the plastic injection molding process and utilize polystyrene, polyethylene and polypropylene. The facility distributes directly to the laboratory distributor and media pour markets and transfers patient utensil products to Tennessee for distribution consolidation. The Company has announced its plan to transfer the Colorado facility manufacturing and product lines to the Tennessee facility and close the Colorado facility during the current fiscal year.
The Company files annual, quarterly and current reports and other information with the SEC. These materials can be inspected and copied at the SECs Public Reference Room at 450 Fifth Street, N.W., Washington, D.C. 20549. Copies of these materials may also be obtained by mail at prescribed rates from the SECs Public Reference Room at the above address. Information about the Public Reference Room can be obtained by calling the SEC at 1-800-SEC-0330. The SEC also maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. The address of the SECs Internet site is http://www.sec.gov.
The Company makes available, free of charge, on its Internet website, located at http://www.medical-action.com its most recent Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q, any current reports on Form 8-K filed since the Companys most recent Annual Report on Form 10-K and any amendments to such reports as soon as reasonably practicable following the electronic filing of such report with the SEC. In addition, the Company provides electronic or paper copies of its filings free of charge upon request.
Item 1A Risk Factors
The following factors, among others, could cause actual results to differ materially from its content in forward-looking statements made in this report and presented elsewhere by management from time-to-time. Such factors, among others may have a material adverse affect on our business, financial condition, and results of operations and you should carefully consider them. It is not possible to predict or identify all such factors. Consequently, you should not consider any such list to be a complete statement of all our potential risks or uncertainties. Because of these and other factors, past performance should not be considered an indication of
Our integration of the acquisition of Medegen Medical Products, LLC (Medegen) is ongoing and we may incur substantial costs to achieve, and may not be able to realize, the anticipated cost savings, synergies or revenue enhancements from integrating Medegens operations with our current business.
If we cannot successfully complete the integration of Medegens operations, including the consolidation of Medegens Colorado manufacturing facility into our Gallaway, Tennessee facility, with our current business, we may experience material negative consequences to our business, financial condition or results of operations and to the business, financial conditions or results of operations of the combined company. The integration of companies that have previously operated separately will continue to be a costly and time-consuming process that will involve a number of risks, including, but not limited to:
Indemnification for Remediation of Tennessee facility
The Medegen Medical Products, LLC (Medegen) Tennessee facility is comprised of approximately 20 acres in a light industrial park, located in Gallaway, TN. During 1998, as part of due diligence activities prior to the acquisition of the facility by Medegen, consultants found chlorinated solvents in the groundwater adjacent to the manufacturing plant, which is in the process of being remediated.
Medegen is fully indemnified by the prior owner (Indemnitor) for all
costs associated with the environmental remediation as well as any claims that may arise, including third party claims. As security for the indemnification obligations, Indemnitor is required, on a quarterly basis, to provide proof of cash balances, marketable securities or available, unused lines of credit equal to the expected cost of all future remediation activities plus $500,000. Now that full-scale remediation has begun, Indemnitor will be required to provide Letters of Credit (LC) to secure their future obligations beginning with a $3,000,000 LC at the 2 year point, dropping $2,000,000 at the 4 year mark and reducing to $1,000,000 from years 7 through 10. The LC amounts approximate the expected remaining remediation costs at each point in time. No assurance can be given that the Indemnitor will have the financial resources to complete the environmental remediation and/or defend any claims that may arise, that recommended cleanup levels will be achieved over the long term, or that further remedial activities will not be required.
The Company may be unable to successfully manage growth, particularly if accomplished through acquisitions.
Successful implementation of the Companys business strategy will require that the Company effectively manage any associated growth. To manage growth effectively, the Companys management will need to continue to implement changes in certain aspects of the Companys business, to enhance the Companys information systems and operations to respond to increased demand, to attract and retain qualified personnel and to develop, train and manage an increasing number of management-level and other employees. Growth could place an increasing strain on the Companys management, financial, marketing, distribution and other resources, and the Company could experience operating difficulties. Any failure to manage growth effectively could have a material adverse affect on the Companys results of operations and financial condition.
To the extent that the Company grows through acquisition, it will face the additional challenges of integrating its current operations, culture, informational management information systems and other characteristics with that of the acquired entity. The Company may incur significant expenses in connection with negotiating and consummating one or more transactions, and it may inherit certain liabilities in connection with the acquisition as a result of its failure to conduct adequate due diligence or otherwise. In addition, the Company may not realize competitive advantages, synergies or other benefits anticipated in connection with such acquisition. If the Company does not adequately identify targets for, or manage issues related to our future acquisitions, such acquisitions may have a negative adverse affect on the Companys business and financial results.
In addition to the above risks, future acquisitions may result in the dilution of earnings and the amortization or write-off of goodwill and
intangible assets, any of which could have a material adverse affect on our business, financial condition or results of operations.
The Companys business is subject to the risks of international procurement.
A significant portion of the Companys raw materials and finished goods are purchased from manufacturers in the Peoples Republic of China. As a result, the Companys international procurement operations are subject to the risks associated with such activities including, economic and labor conditions, international trade regulations (including tariffs and anti-dumping penalties), war, international terrorism, civil disobedience, political instability, governmental activities, deprivation of contract and property rights. In particular, since 1978, the Chinese government has been reforming its economic and political systems, which we expect to continue. Although we believe that these reforms have had a positive effect on the economic development of China and have improved our ability to successfully utilize facilities in China, we cannot assure you that these reforms will continue or that the Chinese government will not take actions that impair these operations in China. In addition, periods of international unrest may impede our ability to procure goods from other countries and could have a material adverse effect on our business and results of operations.
Although the Chinese yuan has traded virtually in a straight line for many years, beginning in fiscal 2006 the Chinese government began to re-value the Chinese yuan against other currencies, including the U.S. dollar. This re-valuation or free floating exchange rate, has caused the price of many items that are sourced from China to increase, which could adversely impact the Companys cost of goods sold and profitability.
In addition, the U.S. Government in May 2005 exercised a quota on any textile products from China in Category 632 of the Harmonized Tariff Schedule, which included the Companys patient slippers. The Company anticipates that a similar quota will be exercised in fiscal 2008 on textile products from China in Category 632. The Company has been able to procure a similar product with a different country of origin, although at higher costs than the Company was previously obtaining. An interruption in supply and higher costs, could have a negative adverse effect on the Companys financial results.
Covenants in our credit facilities may restrict our financial and operating flexibility.
We currently have two credit facilities;
Our current credit facility requires, and any future credit facilities may also require, that we comply with specified financial covenants relating to interest coverage, debt coverage, minimum consolidated net worth, and earnings before interest, taxes, depreciation and amortization. Our ability to satisfy these financial covenants can be affected by events beyond our control, and we cannot give assurance that we will meet the requirements of these covenants. These restrictive covenants could affect our financial and operational flexibility, including the following:
Future operating results are dependent upon the Companys ability to obtain a sufficient supply of raw materials, some of which are available only from limited sourcesvolatility of resin cost.
Although most raw materials essential to the Companys business are generally available from multiple sources, certain key components (including resin, which is the principal raw material used in the manufacture of collection systems for the containment of medical waste) are currently obtained by the Company from limited sources. If a supplier of significant raw materials including component parts, finished goods or services were to terminate its relationship with the Company, or otherwise cease supplying raw materials, component parts, finished goods or services consistent with past practices, the Companys ability to meet its obligations to its customers may be disrupted. A disruption with respect to numerous products, or with respect to a few significant products, could have a material adverse affect on the Companys business and financial
During the past few years, world events have caused the price of oil and natural gas prices to increase to historical new heights, causing the cost of resin to rise to unprecedented levels. The Company anticipates the volatility to continue in fiscal 2008. During the past two fiscal years, the Company has been able from time to time, to increase selling prices for certain of these products to recover a portion of the increased cost. However, there can be no assurance that the Company will be able to pass along future cost increases, if any, to its customers which could also have an adverse impact on the Companys results of operations and financial condition.
The Companys success depends largely on its ability to attract and retain key personnel.
Much of the future success of the Company depends on the continued service and availability of skilled personnel, including its Chief Executive Officer, members of its executive team, and those in manufacturing, marketing, finance, and information technology. The Company has relied on its ability to grant stock options as one mechanism for recruiting and retaining this highly skilled talent. Accounting regulations requiring the expensing of stock options may impair the Companys future ability to provide these incentives without incurring significant compensation costs. There can be no assurance that the Company will continue to successfully attract and retain key personnel.
Failure of the Companys information technology systems could adversely affect the Companys future operating results.
Information technology system failures could disrupt the Companys ability to function in the normal course of business by potentially causing delays or cancellation of customer orders, impeding the manufacture or shipment of products, hindering the planning and procurement of raw materials, or resulting in the unintentional disclosure of customer or Company information. Management has taken steps to address these concerns by its implementation of internal control measures. However, there can be no assurance that a system failure or data security breach will not have a material adverse affect on the Companys results of operations.
During fiscal 2007, the Company implemented a new software system, mySAP software suite. The Company has estimated the effective operational cost for the new software. However, these estimates are based upon several factors including, the hiring and retaining of technical resources, availability of functional business people, accuracy of our current data, and additional requirements resulting from the Medegen acquisition. In the event that such factors are delayed or significantly modified, the cost of the implementation could be significantly increased and have a material
effect on the Companys business and financial condition.
The high level of competition and buying groups place pressure on our profit margins and we may not be able to compete successfully.
The disposable medical device segment of the healthcare industry in which we operate is highly competitive and is experiencing both horizontal and vertical consolidation. All of the products which we sell are available from sources other than us. The high level of competition in our industry places pressure on profit margins. Some of our competitors have greater resources than we have. These competitive pressures could have a material adverse affect on our business, financial condition or results of operations.
Sales to the Companys three largest distributors accounted for more than 60% of total sales in each of the last three fiscal years. Although the distributors may be deemed in a technical sense to be major purchasers of the Companys products, they serve, however, as a distributor under a purchase order or supply agreement between the customer and the Company, and do not purchase for their own accounts. The Company, therefore, does not believe it is appropriate to categorize its distributors as actual customers. However, in some cases, distributors compete with the Company on a private label basis, and if successful, sales of certain of the Companys products could decline which may result in a material affect on the Companys business and financial condition.
Healthcare reform and the related pressure to contain costs has been the advent of buying groups in the United States. These group purchasing organizations enter into preferred supplier arrangements with one or more manufacturers of medical products in return for price discounts to members of the group purchasing organizations. If we are not able to obtain new preferred supplier commitments for major group purchasing organizations or retain those commitments that we currently have, which are generally terminable by either party for any reason upon the expiration of a defined notice period, our sales and profitability could be adversely affected. However, even if we are able to obtain and retain preferred supplier commitments from buying groups, they may not deliver high levels of compliance by their members, meaning that we may not be able to offset the negative impact of lower per-unit prices or lower margins with increases in unit sales or in market share.
The Companys products may be subject to recall or product liability claims.
The Companys products are used in connection with surgical procedures and in other medical contexts in which it is important that those products function with precision and accuracy. If the Companys products do not function as designed, or are designed improperly, the
Company may be forced by regulatory agencies to withdraw such products from the market. In addition, if medical personnel or their patients suffer injury as a result of any failure of the Companys products to function as designed, or an inappropriate design, the Company may be subject to lawsuits seeking significant compensatory and punitive damages. Any product recall or lawsuit seeking significant monetary damages may have a material affect on the Companys business and financial condition.
If a natural or man-made disaster strikes our manufacturing facilities, we may be unable to manufacture our products for a substantial amount of time, which may adversely affect our expected results of operations.
We principally rely on our manufacturing facilities in Arden, North Carolina, Gallaway, Tennessee, and Clarksburg, West Virginia. These facilities may be affected by natural or man-made disasters. These facilities and the manufacturing equipment we use to produce our products would be difficult to replace and could require substantial time to repair or replace. In the event one of our facilities was affected by a disaster, we would be forced to rely on third-party manufacturers. However, third-party manufacturers may not be available or they may be unable to produce our products on the schedule or to the specifications that we require. We currently carry insurance in the aggregate amount of $20 million to protect us against such disasters. However, such insurance may not be sufficient to cover all of our potential losses or may become unavailable on acceptable terms, if available at all.
A significant adverse change in, or failure to comply with, governing regulations could adversely affect the Companys business.
Substantially all the Companys products are devices, as defined in the Federal Food, Drug and Cosmetic Act (FDA), and the manufacture, distribution, record keeping, labeling and advertisement of the Companys products is subject to regulation by the FDA in the United States and its equivalent regulatory agencies in various foreign countries in which the Companys products are manufactured, distributed, labeled, offered and sold. Further, the Company is subject to continual review and periodic inspections at its current facilities with respect to the FDAs Good Manufacturing Practices. The Companys business and financial condition could be adversely affected if it is found to be out of compliance with governing regulations. In addition, if such regulations are amended to become more restrictive and costly to comply with, the costs of compliance could adversely affect the Companys business and financial condition.
The Company is dependent on manufacturing and logistic services provided by third-parties and related risks.
Many of the Companys products are manufactured in whole or part
by third-party manufacturers, which are located throughout the United States and other parts of the world. While outsourcing arrangements may lower the fixed cost of operations, they also reduce the Companys direct control of production and distribution. It is uncertain what affect such diminished control will have on the quality or quantity of the products manufactured, or the flexibility of the Company to respond to changing market conditions. The Company also depends on third-party transportation companies to deliver supplies necessary to manufacture our products from vendors to the Companys various facilities and to move the Companys products to customers within and outside the United States. The Companys manufacturing operations, and the operations of the transportation companies on which the Company depends, may be adversely affected by natural disasters and significant human events, such as a war, terrorist attack, riot, strike, slowdown or similar event. Any disruption in the Companys manufacturing or transportation could materially adversely affect the Companys ability to meet customer demands or its operations generally.
The cost of designing, implementing and staffing an effective corporate governance program to meet current and proposed regulations could affect the Companys future operating results.
The corporate governance programs at the Company anticipated much of what is included in the Sarbanes-Oxley Act of 2002 (Sarbanes-Oxley). We had standards in place for dealing with issues of compliance training, board independence and made use of the lead director concept for committees of the Board of Directors, and an audit committee financial expert. However, as part of its continuing effort to fill in the blanks left by Congress, the SEC implemented rules under Section 404 of Sarbanes-Oxley requiring the Company to include in its annual report an internal control report which (i) confirms managements obligation to establish and maintain adequate internal controls and procedures for financial reporting and (ii) assess, as of year end, the effectiveness of our internal controls and procedures for financial reporting. In addition, Section 404 requires the Companys independent auditors to attest to, and report on, managements assessment. Due to its broad scope of purpose, the time and expense required to enable the Company to comply with Section 404 could be substantial and affect the Companys profitability. In addition there is no assurance that proposed rules such as enhanced shareholder access to the Companys proxy materials, the expensing of stock options, and rules requiring expanded disclosure of the Companys director nomination process and designation of an audit committee financial expert will not have an adverse effect on the Companys future operating results.
The Company quarterly revenue and operating results may fluctuate for a variety of reasons.
The Companys profit margins vary among its products and its
distribution channels. As a result, the overall profitability of the Company in any given period will depend, in part, on the product, geographic, and channel mix reflected in that periods net sales.
Changes in accounting rules could adversely affect the Companys future operating results.
Financial statements are prepared in accordance with U.S. generally accepted accounting principles. These principles are subject to interpretation by various governing bodies, including the Financial Accounting Standards Board (FASB) and the SEC, who interpret and create appropriate accounting regulations. A change from current accounting regulations, or the interpretations thereof, can have a significant affect on the Companys results of operations and could impact the manner in which the Company conducts business.
Unanticipated changes in the Companys tax rates could affect its future results.
The Companys future effective tax rates could be favorably or unfavorably affected by unanticipated changes in tax laws or their interpretation. In addition, the Company is subject to the continuous examination of our income tax returns by the Internal Revenue Service and other tax authorities. The Company regularly assesses the likelihood of adverse outcomes resulting from these examinations to determine the adequacy of our provision for income taxes. There can be no assurance that the outcomes from these continuous examinations will not have an adverse affect on its operating results and financial condition.
The market price of the Companys common stock has been, and may continue to be volatile.
The market price of the Companys common stock has been, and may continue to be, highly volatile for various reasons, including the following:
Anti-Takeover provisions of our charter documents and Delaware law could prevent or delay transactions resulting in a change of control.
Provisions of our certificate of incorporation and bylaws and applicable provisions of Delaware law may make it more difficult for or prevent a third party from acquiring control of us without the approval of our board of directors. These provisions:
Item 1B Unresolved Staff Comments
The Company owns manufacturing facilities in Gallaway, Tennessee, Arden, North Carolina and Clarksburg, West Virginia. The Company acquired in March 2007, a 28,200 square foot building in Brentwood, New York to serve as the Companys new corporate headquarters. In addition, the Company leases a manufacturing facility in Northglenn, Colorado and general office space in Shanghai, China. Management believes that the Companys facilities are adequate to meet its current needs and should continue to be adequate for the foreseeable future. Additional information about our facilities is set forth in the following table:
ITEM 3LEGAL PROCEEDINGS
The Company is a party to a lawsuit arising out of the conduct of its business in the ordinary course. While the results of such lawsuit cannot be predicted with certainty, management does not expect that the ultimate liability, if any, will have a material adverse effect on the financial position or results of operations of the Company.
ITEM 4SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
No matters were submitted to a vote of security holders during the fourth quarter of the fiscal year.
ITEM 5MARKET FOR REGISTRANTS COMMON EQUITY, RELATED STOCK-HOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
The information required by this Item is set forth in registrants 2007 Annual Report to Stockholders under the captions Selected Financial Data, Stock Trading and Managements Discussion and Analysis of Financial Condition and Results of Operations, which information is hereby incorporated herein by reference.
ITEM 6SELECTED FINANCIAL DATA
The information required by this Item is set forth in registrants 2007 Annual Report to Stockholders contained under the caption Selected Financial Data, which information is hereby incorporated herein by reference.
ITEM 7MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The information required by this Item is set forth in registrants 2007 Annual Report to Stockholders contained under the caption Managements Discussion and Analysis of Financial Condition and Results of Operations, which information is hereby incorporated herein by reference.
ITEM 7A QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The information required by this Item is set forth in registrants 2007 Annual Report to Stockholders contained under the caption Managements Discussion and Analysis of Financial Condition, which information is hereby incorporated herein by reference.
ITEM 8FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The information required by this Item is set forth in registrants 2007 Annual Report to Stockholders under the captions Reports of Independent Registered Public Accounting Firm, Balance Sheets, Statements of Operations, Statements of Shareholders Equity, Statements of Cash Flows and Notes to Financial Statements, which information is hereby incorporated herein by reference.
ITEM 9CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
ITEM 9ACONTROLS AND PROCEDURES
The Companys management, with the participation of the Chief Executive Officer and Principal Financial Officer, evaluated the effectiveness of the Companys disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Act) as of March 31, 2007. Based on this evaluation, the Chief Executive Officer and Principal Financial Officer concluded that, as of March 31, 2007, the Companys disclosure controls and procedures were (i) designed to ensure that material information relating to the Company, is made known to the Companys Chief Executive Officer and Principal Financial Officer, particularly during the period in which this report was being prepared and (ii) effective, in that they provide reasonable assurance that information required to be disclosed by the Company in the reports that it files or submits under the Securities Act is recorded, processed, summarized and reported within the time periods specified in the SECs rules and forms.
No change in the Companys internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the fiscal quarter ended March 31, 2007 that has materially affected, or is reasonably likely to materially affect, the Companys internal control over financial reporting.
See the Companys Annual Report To Stockholders for our Managements Report on Internal Control Over Financial Reporting.
Item 9BOther Information
Item 10 Directors and Executive Officers of the Registrant
The following is a list of the names and ages of all of our directors and executive officers, including all positions and offices they hold with the Company as of June 1, 2007. The Companys Certificate of Incorporation provides that the board of directors shall consist from between three and eleven members, as determined from time to time by the board, divided into three classes as nearly equal in number as possible. Our executive officers hold office at the pleasure of the board of directors.
Paul D. Meringolo, a director and Chairman of the Board and Chief Executive Officer of the Company since October 1997, has been employed by the Company for more than the past twenty years in various executive positions. He also serves the Company as President (since November 1992), and previously held the position of Vice President of Operations from March 1989 to October 1991 and Senior Vice President (Chief Operating Officer) from October 1991 to November 1992.
Mr. Richard G. Satin, previously a director of the Company from October 1987 to February 1992, was reappointed to the Board of Directors in February 1993. Mr. Satin has been employed by the Company as Vice President and General Counsel since January 1993 and has been Corporate Secretary of the Company since October 1991. In February 1994, Mr. Satin was appointed Vice President of Operations. Mr. Satin, a practicing attorney in the State of New York for more than the past twenty years, was associated with the law firm of Blau, Kramer, Wactlar, Lieberman & Satin, P.C. from May 1983 to January 1993.
Mr. Manuel B. Losada, has been an executive officer of the Company since August 2004 as Vice President of Sales and Marketing. For the year prior thereto, Mr. Losada was Senior Vice President Chief Sales Officer of B. Braun Medical U.S.A., a global organization offering products in IV therapy, pain control, vascular interventional, dialysis and nutrition. For the four years prior thereto, Mr. Losada was Vice President Corporate Business Management for Henry Schein, Inc., a distributor of healthcare products and services primarily to office-based healthcare practitioners in the North America and European markets.
Mr. Eric Liu, has been employed by the Company for more than the past ten years in various positions relating to the international procurement of raw materials and the manufacture of certain of the Companys products. Mr. Liu was appointed Vice President of International Operations and Global Development in May 2005. For more than the five years prior thereto Mr. Liu was Vice President of International Operations. Mr. Liu received a Bachelor of Science degree from The National Taiwan Marine University and a Master of Science degree in Transportation Management from the State University of New York.
Henry A. Berling, a director since August 2005, retired on December 31, 2004 as Executive Vice President after 38 years with Owens & Minor, Inc., a publicly traded Fortune 500 supply-chain solutions company and a leading distributor of name-brand medical and surgical supplies. From 1995 to 2002 Mr. Berling served as Executive Vice President, Partnership Development. Prior to 1995, he served Owens & Minor, Inc. in various positions, including Executive Vice President, Sales and Customer Development and Senior Vice President, Sales and Marketing. Mr. Berling was a member of the Owens & Minor Board of Directors from 1998 to 2005. For more than the past three years, Owens & Minor, Inc. has been the Companys largest distributor.
Mr. William W. Burke, a director since August 2004, has served as Executive Vice President and Chief Financial Officer of ReAble Therapeutics, Inc. (formerly known as Encore Medical Corporation), a diversified orthopedic device company since August 2004. Mr. Burke served as Chief Financial Officer, Treasurer and Secretary of Cholestech Corporation, a publicly traded medical products company from March 2001 to August 2004. For more than fifteen years prior thereto, Mr. Burke was a senior investment banker with such firms as Bear, Stearns & Co., Inc., Everen Securities, Inc. and Principal Financial Securities, where he provided financing and advisory services to companies in healthcare and other industry sectors. Mr. Burke holds a Bachelors of Business Administration degree in Finance from the University of Texas at Austin and a Masters of Business Administration degree from University of Pennsylvanias Wharton Graduate Business School.
Dr. Philip F. Corso, a director of the Company since March 1984, has been associated with the Yale University School of Medicine for more than the past ten years and is presently an Assistant Clinical Professor of Surgery
Emeritus. In addition, Dr. Corso is Senior Attending and Emeritus Chief of Plastic Surgery at Bridgeport and Norwalk Hospitals in Connecticut. Dr. Corso has also published numerous articles in professional journals on plastic and reconstructive surgery. He is a member of numerous national and international plastic surgery societies.
Mr. Kenneth Newsome, a director of the Company since August 2006, has been President and CEO of AMF Automation Technologies, Inc., a privately held manufacturer of wholesale bread and baking equipment since 1996. With approximately 300 employees worldwide, AMF has completed seven acquisitions to date. For more than the four years prior thereto, Mr. Newsome held various executive positions, including Chief Operating Officer of MedSurg Industries, which was acquired by Isolyser Healthcare, which is now known as Microtek Medical Inc., a publicly traded medical products company. Mr. Newsome holds a Bachelors of Science degree in Finance from the University of Virginia McIntire School of Commerce and a Masters of Business Administration degree from the University of Virginia Darden School of Graduate Business Administration.
Mr. Bernard Wengrover, a director of the Company since October 1990, has been a certified public accountant in the State of New York for more than the past forty years. Mr. Wengrover was the Companys independent auditor from 1977 until March 31, 1989.
The Audit Committee assists the Board in its oversight of the integrity of the Companys financial statements, legal and regulatory compliance, the independent auditors qualifications and independence, and the performance of the Companys internal audit function and of the independent auditors. The Audit Committee recommends for approval by the Stockholders, a firm of independent certified public accountants whose duty is to examine the Companys financial statements. The Audit Committee has the sole authority and responsibility to appoint, subject to Stockholder approval, compensate and oversee the independent auditors, and to pre-approve all engagements, fees and terms for audit and other services provided by the Companys independent auditors. The independent auditors are accountable to the Audit Committee. Mr. Burke is Chair of the Audit Committee and is the audit committee financial expert as defined by applicable SEC rules.
The Compensation Committee assists the Board in discharging its responsibilities with regard to executive compensation and oversight of the general compensation philosophy of the Company and prepares a report on executive compensation to the Companys stockholders. It is responsible for reviewing and approving the objectives, evaluating the
performance, and reviewing and recommending the compensation of the Chief Executive Officer to the Board. The Compensation Committee also administers the Companys stock option plans. Dr. Corso is Chair of the Compensation Committee.
Nominating and Governance Committee
The Nominating and Governance Committee assists the Board in identifying individuals qualified to become directors under criteria approved by the Board. The committee recommends to the Board the number and names of persons to be proposed by the Board for election as directors at the annual general meeting of stockholders and may also recommend to the Board persons to be appointed by the Board or to be elected by the stockholders to fill any vacancies which occur on the Board. The Nominating and Governance Committee is responsible for periodically reviewing director compensation and benefits, reviewing corporate governance trends, and recommending to the Board any improvements to the Companys corporate governance guidelines as it deems appropriate. The Nominating and Governance Committee also recommends directors to serve on and to chair the Board Committees and leads the Boards appraisal process. Mr. Wengrover is Chair of the Nominating and Governance Committee.
Directors Fees. Non-employee Directors receive a $1,000 monthly retainer, a $1,000 fee for each board meeting they attend, and a $500 fee for each telephonic Board Meeting they attend. Non-employee Directors also receive a $500 fee for each Committee Meeting they attend that is on the same day as a regular Board meeting (with the exception of the Chairman of each Committee who receives $1,000). For such Committee meetings that non-employee Directors attend that are not on the same day as a regular Board meeting, they receive a $1,000 fee for each meeting (with the exception of the Chairman of each Committee who receives $2,000). For telephonic Committee meetings that non-employee Directors attend, they receive a $500 fee for each meeting (with the exception of the Chairman of each Committee who receives $1,000).
Stock Options. In August 1996, stockholders approved the 1996 Non-Employee Directors Stock Option Plan, under which all Directors who are not also employees of the Company will be automatically granted each year at the Annual Meeting of Stockholders options to purchase 2,500 shares at the fair market value of the Companys Common Stock on the date of grant. All options are exercisable from the date of grant.
Item 11 Executive Compensation
See information under the caption Compensation Discussion and Analysis in the Companys Proxy Statement, which information is incorporated herein by reference.
Item 12 Security Ownership of Certain Beneficial Owners and Management
See the information under the caption Stock Ownership Information in the Companys Proxy Statement, which information is incorporated herein by reference.
Item 13 Certain Relationships and Related Transactions
See the information under the caption Certain Relationships and Related Transactions in the Companys Proxy Statement, which information is incorporated herein by reference.
Item 14 Principal Accounting Fees and Services
See the information under the caption Ratification of Independent Certified Registered Public Accounting Firm in the Companys Proxy Statement, which information is incorporated herein by reference.
Those items which are incorporated by reference to the Companys definitive Proxy Statement relating to the Annual Meeting of Stockholders is scheduled to be held on August 16, 2007. The definitive Proxy Statement will be filed with the Commission not later than 120 days after March 31, 2007, pursuant to Regulation 14A of the Securities Exchange Act of 1934, as amended.
ITEM 15 EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) (1) and (2) List of Financial Statements and Financial Statement Schedules
The following financial statements of Medical Action Industries Inc., included in its Annual Report to Stockholders for the year ended March 31, 2007, are incorporated by reference in Item 8:
Balance Sheets at March 31, 2007 and 2006
Statements of Operations for the Years Ended March 31, 2007, 2006 and 2005
Statements of Shareholders Equity for the Years Ended March 31, 2007, 2006 and 2005
Statements of Cash Flows for the Years Ended March 31, 2007, 2006 and 2005
Notes to Financial Statements
The following financial statement schedule and Report of Independent Registered Public Accounting Firm of Medical Action Industries Inc. and Subsidiaries is included in Item 14(d):
Report of Independent Registered Public Accounting Firm on Schedule II Valuation and Qualifying Accounts
All other schedules for which provision is made in the applicable accounting regulations of the Securities and Exchange Commission are not required under the related instructions or are inapplicable and therefore have been omitted.
The response to this portion of Item 16 is submitted as a separate section of this report.
(c) Financial Statement Schedules
The response to this portion of Item 16 is submitted as a separate section of this report.
With the exception of the aforementioned information incorporated by reference in this Annual Report on Form 10-K, the Companys Annual Report to Stockholders for the year ended March 31, 2007 is not to be deemed filed as part of this report.
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized on this 8th day of June, 2007.
MEDICAL ACTION INDUSTRIES INC.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below on June 8th, 2007 by the following persons in the capacities indicated:
REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM ON SCHEDULE
REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM ON SCHEDULE
Stockholders and Board of Directors
Medical Action Industries Inc.
We have audited in accordance with the standards of the Public Company Accounting Oversight Board (United States) the consolidated financial statements of Medical Action Industries Inc. and subsidiaries referred to in our report dated May 31, 2007, which is included in the annual report to security holders and incorporated by reference in Part II of this form. Our report on the consolidated financial statements includes explanatory paragraphs relating to the application of Financial Accounting Standards No. 123(R) as of April 1, 2006 and No. 158 as of March 31, 2007. Our audit was conducted for the purpose of forming an opinion on the basic financial statements taken as a whole. The Schedule II is presented for purposes of additional analysis and is not a required part of the basic financial statements. This schedule has been subjected to the auditing procedures applied in the audit of the basic financial statements and, in our opinion, is fairly stated in all material respects in relation to the basic financial statements taken as a whole.
GRANT THORNTON LLP
New York, New York
May 31, 2007
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d)
OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE FISCAL YEAR ENDED March 31, 2007
MEDICAL ACTION INDUSTRIES INC.
(Exact name of registrant as specified in its charter)
SCHEDULE II - VALUATION AND QUALIFYING ACCOUNTS
MEDICAL ACTION INDUSTRIES INC.